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Desfibrilador S8 S6 Comen

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User Manual for Defibrillator Monitor

Copyright
Shenzhen Comen Medical Instruments Co., Ltd.
Version: B00
Product Name: Defibrillator Monitor
Product Model: S8/S6
Revision date: 2020/11
No.:046-001589-03

Statement
All rights reserved by Shenzhen Comen Medical Instruments Co., Ltd.

This instruction manual contains confidential information. It is only intended for users as a reference for
operation, maintenance and repair of Comen products. No one shall disclose the contents hereof to any other
person.
No part of this manual may be reproduced, transmitted, transcribed or stored in a retrieval system in any form
or by any means, electronic or mechanical, including photocopying and recording, or translated into any other
language, without written permission of Comen.
Comen shall assume no liability for any errors contained herein or any incidental or indirect damages arising
from provision, actual performance or use of this manual. This User Manual does not imply the transfer of any
proprietary right under patent law to any third party. Comen shall not be liable for any legal consequences
arising out of breach of the patent law or infringement of any third-party rights.
The contents in this manual are subject to change without prior notice.

Warranty
Comen will be responsible for the safety, reliability and performance of the product within the limited
warranty period: if all of the following conditions are satisfied:
 The product is used in accordance with this Manual.

 The product is installed, maintained or upgraded by persons accepted or authorized by Comen.

 The storage, operating and electrical environments for the product comply with the product
specifications.

 The serial number label or manufacturing mark of the product is clearly legible.

 The damage is not caused by human factors.


The product will be repaired or replaced free of charge within the limited warranty period. After the limited
warranty period, Comen will charge for the service and replacement parts. If the products need to be returned
to Comen for maintenance, the freight charges (including the customs duty) should be on the customer’s
account.

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User Manual for Defibrillator Monitor

Return
If the products need to be returned to Comen, please contact the After-sales Service Department of Comen to
get the right to return the goods. You must provide the serial number of the product, which can be found on
the product’s nameplate. If the serial number is illegible, your return request will be rejected. Please also
present the production date and briefly describe the reason for return.

After-sales Service Unit


Name: After-sales Service Department of Shenzhen Comen Medical Instruments Co., Ltd
Address: F10 of BLDG 1A FIYTA Timepiece Building, Nanhuan Avenue, Matian Subdistrict, Guangming
District 518106 Shenzhen Guangdong P.R.China
Tel.: 0086-755-26431236, 0086-755-86545386, 0086-755-26074134
Fax: 0755-26431232

Customer Service Hotline: 4007009488

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User Manual for Defibrillator Monitor

Preface
This manual provides details on the performance, operations and safety instructions of User Manual for S8/S6
defibrillator monitor (hereinafter referred to as the ―monitor‖). It is the best starting point for new users of the
monitor.

Intended Readers
This user manual is only intended to trained professionals who are expected to have working knowledge of
medical procedures, practices and terminology as required for monitoring patients.
Illustrations
All illustrations provided herein are for reference only. The menus, options, values and functions shown in the
illustrations may be not exactly identical to what you see on the monitor.
Basic Performance
What is claimed to be determined as basic performance is:
1) Defibrillation energy release accuracy of defibrillation monitor;

2) Pacing frequency accuracy;

3) Pacing current accuracy;

4) HR detection accuracy;

5) RESP measurement accuracy;

6) TEMP measurement error;

7) NIBP measurement accuracy;

8) IBP measurement accuracy;

9) SpO2 measurement accuracy;

10) PR measurement accuracy.

11) CO2 measurement accuracy;


Conventions:
 —>: Indicates operating steps.

 [Character]: Indicates user interface text.


Bold italic: Used to indicate the quoted chapter

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User Manual for Defibrillator Monitor

Blank Page

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User Manual for Defibrillator Monitor

Contents
Chapter 1 Safety ............................................................................................................................................... 1-1
1.1 Safety Information .................................................................................................................................. 1-1
1.2 Contraindications.................................................................................................................................... 1-3
1.3 Symbols .................................................................................................................................................. 1-4
Chapter 2 Overview.......................................................................................................................................... 2-1
2.1 Product Introduction ............................................................................................................................... 2-1
2.1.1 Intended Use .................................................................................................................................... 2-1
2.1.2 Components ..................................................................................................................................... 2-1
2.2 MonitorViews ......................................................................................................................................... 2-2
2.2.1 Front View ....................................................................................................................................... 2-2
2.2.1.1 Area 1 ....................................................................................................................................... 2-3
2.2.1.2 Area 2 ....................................................................................................................................... 2-4
2.2.1.3 Area 3 ....................................................................................................................................... 2-4
2.2.1.4 Area 4 ....................................................................................................................................... 2-5
2.2.2 Right View ...................................................................................................................................... 2-6
2.2.3 Left View ......................................................................................................................................... 2-7
2.2.4 Rear View ........................................................................................................................................ 2-8
2.2.5 External Defibrillation Electrode Paddle ......................................................................................... 2-9
2.3 OSD (On-screen Display)....................................................................................................................... 2-9
2.4 Operating Mode .................................................................................................................................... 2-11
2.4.1 Manual Defibrillation Mode .......................................................................................................... 2-12
2.4.2 Monitor Mode................................................................................................................................ 2-12
2.4.3 Pacer Mode .................................................................................................................................... 2-12
2.4.4 AED Mode .................................................................................................................................... 2-12
Chapter 3 Installation ....................................................................................................................................... 3-1
3.1 Unpacking and Checking ....................................................................................................................... 3-1
3.2 Connection of AC Power Cord............................................................................................................... 3-2
3.3 Start-up ................................................................................................................................................... 3-2
3.4 Connecting the Sensor or Patient Cable ................................................................................................. 3-3
Chapter 4 Patient Safety ................................................................................................................................... 4-1
4.1 Safety Instructions .................................................................................................................................. 4-1
4.2 Environmental Requirements ................................................................................................................. 4-1
4.3 Protective Grounding.............................................................................................................................. 4-1
4.4 Equipotential Grounding ........................................................................................................................ 4-1
4.5 Condensation .......................................................................................................................................... 4-2
Chapter 5 Basic Operations .............................................................................................................................. 5-1
5.1 Enter Main Menu.................................................................................................................................... 5-1
5.2 Enter User Maintain Menu ..................................................................................................................... 5-1

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5.3 View Monitor Info.................................................................................................................................. 5-2


5.4 Enter Parameter Setup Window ............................................................................................................. 5-2
5.5 General Setup ......................................................................................................................................... 5-2
5.5.1 Time Setup ...................................................................................................................................... 5-2
5.5.2 Language Setup ............................................................................................................................... 5-2
5.5.3 Measurement Unit Setup ................................................................................................................. 5-2
5.5.4 Brightness Setup .............................................................................................................................. 5-3
5.5.5 Keys Backlight Setup ...................................................................................................................... 5-3
5.5.6 Screen Setup .................................................................................................................................... 5-3
5.5.7 Volume Setup .................................................................................................................................. 5-4
5.5.8 Waveform Freeze ............................................................................................................................ 5-4
5.5.9 Event Setup...................................................................................................................................... 5-5
5.5.10 Module Switch Setup .................................................................................................................... 5-5
5.5.11 User Password Setting ................................................................................................................... 5-5
5.5.12 High Contrast Display ................................................................................................................... 5-6
5.5.13 Demo ............................................................................................................................................. 5-6
Chapter 6 Patient Management ........................................................................................................................ 6-1
6.1 Admit ...................................................................................................................................................... 6-1
6.2 Quick Admit ........................................................................................................................................... 6-2
6.3 Discharge ................................................................................................................................................ 6-2
6.4 Document Manage.................................................................................................................................. 6-3
6.4.1 Save Tactics ..................................................................................................................................... 6-4
Chapter 7 Configuration Management ............................................................................................................. 7-1
7.1 Department ............................................................................................................................................. 7-1
7.2 Manual Defibrillation Settings ............................................................................................................... 7-1
7.3 AED Settings .......................................................................................................................................... 7-2
7.4 Pacer Settings ......................................................................................................................................... 7-3
7.5 12-Lead Settings ..................................................................................................................................... 7-3
7.6 Save as User Config ............................................................................................................................... 7-3
7.7 Delete Config ......................................................................................................................................... 7-3
7.8 Load Config............................................................................................................................................ 7-3
7.9 Import Config from USB........................................................................................................................ 7-4
7.10 Export Config to USB .......................................................................................................................... 7-4
7.11 Startup Configuration ........................................................................................................................... 7-4
7.12 Record Settings..................................................................................................................................... 7-4
7.13 Test Settings ......................................................................................................................................... 7-4
7.14 Network Settings .................................................................................................................................. 7-5
Chapter 8 Monitor Screen ................................................................................................................................ 8-1
8.1 Standard .................................................................................................................................................. 8-1

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8.2 12-lead Screen ........................................................................................................................................ 8-1


8.3 Set Screen Style in Monitoring Mode .................................................................................................... 8-3
8.3.1 Set Wave Sweep Speed ................................................................................................................... 8-3
8.3.2 Set Wave Style ................................................................................................................................ 8-3
8.3.3 Set Module Color ............................................................................................................................ 8-3
8.3.4 Set Wave Draw ................................................................................................................................ 8-3
8.3.5 Set Wave Fill ................................................................................................................................... 8-3
8.3.6 Change Screen Layout ..................................................................................................................... 8-4
Chapter 9 Alarm ............................................................................................................................................... 9-1
9.1 Alarm Type............................................................................................................................................. 9-1
9.2 Alarm Level ............................................................................................................................................ 9-1
9.3 Alarm Mode ........................................................................................................................................... 9-2
9.3.1 Alarm Lamp..................................................................................................................................... 9-2
9.3.2 Audible Alarm ................................................................................................................................. 9-3
9.3.3 Alarm Message ................................................................................................................................ 9-3
9.3.4 Alarm Parameter Flashing ............................................................................................................... 9-3
9.4 Set Alarm Volume .................................................................................................................................. 9-4
9.4.1 Set Minimum Alarm Volume .......................................................................................................... 9-4
9.4.2 Set Alarm Volume ........................................................................................................................... 9-4
9.4.3 Set Alarm Reminder ........................................................................................................................ 9-5
9.5 Set Parameter Alarm............................................................................................................................... 9-5
9.5.1 Set Alarm Limit ............................................................................................................................... 9-5
9.5.2 Set Auto Alarm Limit ...................................................................................................................... 9-6
9.6 Set Alarm Delay ..................................................................................................................................... 9-6
9.7 Set Alarm Recording .............................................................................................................................. 9-7
9.8 Alarm Pause ........................................................................................................................................... 9-7
9.9 Alarm OFF ............................................................................................................................................. 9-8
9.10 Alarm System Off................................................................................................................................. 9-8
9.11 Alarm Reset .......................................................................................................................................... 9-8
9.12 Alarm System Test ............................................................................................................................... 9-9
Chapter 10 PR Setup ...................................................................................................................................... 10-1
10.1 Overview ............................................................................................................................................ 10-1
10.2 PR Source ........................................................................................................................................... 10-1
10.3 Alarm Limit Setup .............................................................................................................................. 10-1
Chapter 11 ECG Monitoring .......................................................................................................................... 11-1
11.1 Definition of ECG Monitoring ........................................................................................................... 11-1
11.2 Precautions for ECG Monitoring........................................................................................................ 11-1
11.3 ECG Display....................................................................................................................................... 11-2
11.4 Monitoring Steps ................................................................................................................................ 11-3

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11.4.1 Prepare Skin................................................................................................................................. 11-3


11.4.2 Install ECG Leads........................................................................................................................ 11-3
11.4.2.1 Place 3-lead Electrodes ......................................................................................................... 11-4
11.4.2.2 Place 5-lead Monitoring Electrodes...................................................................................... 11-5
11.4.2.3 Place 12-lead Monitoring Electrodes.................................................................................... 11-6
11.4.2.4 Recommended ECG Lead Connection for Surgical Patient ................................................. 11-7
11.4.3 Placement of Pads or External Paddles ....................................................................................... 11-8
11.4.3.1 Preparation ............................................................................................................................ 11-8
11.4.3.2 Anterior-Lateral Placement ................................................................................................... 11-8
11.5 ECG Setup .......................................................................................................................................... 11-9
11.5.1 Checking the Pacing Status ......................................................................................................... 11-9
11.5.2 Set Lead Type .............................................................................................................................. 11-9
11.5.3 Smart Lead Off .......................................................................................................................... 11-10
11.5.4 Set Alarm Level for Lead Off.................................................................................................... 11-10
11.5.5 Set Lead Name for Monitoring .................................................................................................. 11-10
11.5.6 Set Wave Gain ........................................................................................................................... 11-10
11.5.7 Set Filter Mode .......................................................................................................................... 11-11
11.5.8 Set Computation Lead ............................................................................................................... 11-11
11.5.9 Set Notch Filter.......................................................................................................................... 11-12
11.5.10 Set Pacer Rejection .................................................................................................................. 11-13
11.5.11 HR Source ............................................................................................................................... 11-13
11.5.12 Multiple Lead Analysis ........................................................................................................... 11-13
11.5.13 Cascade .................................................................................................................................... 11-13
11.6 ST Segment Analysis ....................................................................................................................... 11-14
11.6.1 About ST Segment Analysis...................................................................................................... 11-14
11.6.2 Influence Factors on ST Segment .............................................................................................. 11-14
11.6.3 ST Analysis On/Off ................................................................................................................... 11-14
11.6.4 Adjust ST Point ......................................................................................................................... 11-15
11.6.5 ST Analysis Review .................................................................................................................. 11-16
11.6.6 ST Alarm ................................................................................................................................... 11-16
11.7 Arrhythmia Analysis ........................................................................................................................ 11-17
11.7.1 Arrhythmia Analysis On/Off ..................................................................................................... 11-17
11.7.2 Arrhythmia Alarm Setup ........................................................................................................... 11-17
11.7.3 Arrhythmia Threshold Setup ..................................................................................................... 11-18
11.7.4 Arrhythmia Review ................................................................................................................... 11-18
11.7.5 ARR Relearn ............................................................................................................................. 11-19
11.8 ECG Relearn..................................................................................................................................... 11-19
Chapter 12 Manual Defibrillation and Synchronized Cardioversion ............................................................. 12-1
12.1 Overview ............................................................................................................................................ 12-1

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12.2 Safety Information .............................................................................................................................. 12-1


12.3 Manual Defibrillation Interface .......................................................................................................... 12-2
12.4 Steps of Manual Defibrillation ........................................................................................................... 12-3
12.4.1 Using Child External Paddles ...................................................................................................... 12-4
12.5 Synchronized Cardioversion .............................................................................................................. 12-4
12.5.1 Steps of Synchronized Cardioversion.......................................................................................... 12-5
12.5.2 Giving Another Shock ................................................................................................................. 12-5
12.5.3 Exit Synchronized Cardioversion Mode...................................................................................... 12-6
12.6 Remote Synchronized Cardioversion ................................................................................................. 12-6
12.7 Contact Impedance Indicator .............................................................................................................. 12-7
Chapter 13 Noninvasive Pacing ..................................................................................................................... 13-1
13.1 Overview ............................................................................................................................................ 13-1
13.2 Safety Information .............................................................................................................................. 13-1
13.3 Pacing Interface .................................................................................................................................. 13-2
13.4 Pacing Mode ....................................................................................................................................... 13-2
13.5 Preparation for Noninvasive Pacing ................................................................................................... 13-3
13.5.1 Steps of Demand Pacing .............................................................................................................. 13-3
13.5.2 Steps of Fixed Pacing .................................................................................................................. 13-4
Chapter 14 AED ............................................................................................................................................. 14-1
14.1 Overview ............................................................................................................................................ 14-1
14.2 Safety Information .............................................................................................................................. 14-1
14.3 AED Interface..................................................................................................................................... 14-2
14.4 AED Procedure................................................................................................................................... 14-2
14.5 Shock Advised .................................................................................................................................... 14-3
14.6 No Shock Advised .............................................................................................................................. 14-4
14.7 CPR .................................................................................................................................................... 14-4
14.7.1 Using CPR Metronome ............................................................................................................... 14-5
14.8 AED Audio Recording ....................................................................................................................... 14-5
Chapter 15 Resp Monitoring .......................................................................................................................... 15-1
15.1 Resp Measurement ............................................................................................................................. 15-1
15.2 Resp Display....................................................................................................................................... 15-1
15.3 Placement of Electrodes ..................................................................................................................... 15-1
15.3.1 Optimization of Lead Position ..................................................................................................... 15-1
15.4 Resp Calculation Mode ...................................................................................................................... 15-2
15.5 Resp Setup .......................................................................................................................................... 15-3
15.5.1 Gain ............................................................................................................................................. 15-3
15.5.2 Resp Lead .................................................................................................................................... 15-3
15.5.3 No Breath Alarm Delay ............................................................................................................... 15-4
15.5.4 Enhance Filter .............................................................................................................................. 15-4

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Chapter 16 SpO2 Monitoring .......................................................................................................................... 16-1


16.1 Overview ............................................................................................................................................ 16-1
16.1.1 Identification of SpO2 Sensor Type ............................................................................................. 16-1
16.2 SpO2 Display ...................................................................................................................................... 16-2
16.3 Safety Instructions .............................................................................................................................. 16-2
16.3.1 Masimo SpO2 Specific Information ............................................................................................ 16-5
16.4 SpO2 Accuracy Test ............................................................................................................................ 16-6
16.5 Low Perfusion Accuracy Test ............................................................................................................ 16-6
16.6 PR Accuracy Test ............................................................................................................................... 16-6
16.7 Monitoring Steps ................................................................................................................................ 16-7
16.8 Measurement Restrictions .................................................................................................................. 16-8
16.9 SpO2 Setup ......................................................................................................................................... 16-9
16.9.1 Set Off Level ............................................................................................................................... 16-9
16.9.2 Smart Alarm ................................................................................................................................ 16-9
16.9.3 Smart Pulse Tone....................................................................................................................... 16-10
16.9.4 NIBP Same Side ........................................................................................................................ 16-10
16.9.5 Set Signal IQ.............................................................................................................................. 16-11
16.9.6 Average Time ............................................................................................................................ 16-11
16.9.7 Fast Sat ...................................................................................................................................... 16-11
16.9.8 Sensitivity .................................................................................................................................. 16-12
16.10 Masimo Information ....................................................................................................................... 16-12
Chapter 17 NIBP Monitoring ......................................................................................................................... 17-1
17.1 Overview ............................................................................................................................................ 17-1
17.1.1 NIBP Display............................................................................................................................... 17-1
17.2 Safety Instructions .............................................................................................................................. 17-2
17.3 NIBP Measurement ............................................................................................................................ 17-2
17.3.1 Preparations for Measurement ..................................................................................................... 17-2
17.3.2 Measurement Restrictions ........................................................................................................... 17-3
17.3.3 Start the Measurement ................................................................................................................. 17-4
17.3.3.1 Start the Manual Measurement ............................................................................................. 17-4
17.3.3.2 Start the Whole Point Measurement ..................................................................................... 17-4
17.3.3.3 Start the Interval Measurement............................................................................................. 17-5
17.3.3.4 Start the Continual Measurement ......................................................................................... 17-5
17.3.4 Stop the Measurement ................................................................................................................. 17-6
17.4 NIBP Setup ......................................................................................................................................... 17-6
17.4.1 Patient Type ................................................................................................................................. 17-6
17.4.2 Initial Pressure ............................................................................................................................. 17-6
17.5 NIBP Reset ......................................................................................................................................... 17-6
17.6 Assistance in Venipuncture ................................................................................................................ 17-6

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Chapter 18 Temp Monitoring ......................................................................................................................... 18-1


18.1 Temp Monitoring ............................................................................................................................... 18-1
18.2 Temp Display ..................................................................................................................................... 18-1
18.3 Safety instructions .............................................................................................................................. 18-1
18.3.1 Temp Measurement ..................................................................................................................... 18-2
Chapter 19 CO2 Monitoring ........................................................................................................................... 19-1
19.1 Overview ............................................................................................................................................ 19-1
19.2 Measurement Principle and Working Process .................................................................................... 19-2
19.3 CO2 Module Connection ..................................................................................................................... 19-2
19.4 Measurement Steps for Respironics Mainstream and Sidestream Analyzer ...................................... 19-4
19.5 Measurement Steps for Masimo Mainstream and Sidestream Analyzer ............................................ 19-6
19.5.1 Measurement Steps ...................................................................................................................... 19-6
19.5.2 Checks before Use ....................................................................................................................... 19-6
19.6 CO2 Setup ........................................................................................................................................... 19-7
19.6.1 Work Mode.................................................................................................................................. 19-7
19.6.2 Pressure Unit ............................................................................................................................... 19-7
19.6.3 Gas Compensation ....................................................................................................................... 19-7
19.6.4 No Breath Alarm Delay ............................................................................................................... 19-8
19.6.5 Altitude ........................................................................................................................................ 19-8
19.6.6 Balance Gas ................................................................................................................................. 19-8
19.6.7 Waveform Scale .......................................................................................................................... 19-9
19.7 Maintenance and Cleaning of Respironics Mainstream and Sidestream CO2Module........................ 19-9
19.7.1 General Cleaning ......................................................................................................................... 19-9
19.7.2 Disinfection of Reusable Airway Adapter ................................................................................... 19-9
19.7.3 Disinfection Frequency of Reusable Airway Adapter ................................................................. 19-9
19.7.4 Zeroing ........................................................................................................................................ 19-9
19.8 Masimo Sidestream Module Related Information ............................................................................ 19-10
19.8.1 Zeroing ...................................................................................................................................... 19-10
19.8.1.1 Zeroing ISA CO2 Module ................................................................................................... 19-10
19.8.2 CO2Module LED ....................................................................................................................... 19-10
19.8.3 Adverse Effects on Performance ............................................................................................... 19-10
19.8.4 Warning Information ................................................................................................................. 19-12
19.8.4.1 ISA Sidestream Gas Analyzer Warning Information .......................................................... 19-12
19.8.5 Airway Obstruction ................................................................................................................... 19-13
19.8.6 Discharging Waste Gases .......................................................................................................... 19-13
19.8.7 Leakage Check .......................................................................................................................... 19-13
19.8.8 Safety Symbols .......................................................................................................................... 19-13
19.8.9 Patents and Trademarks ............................................................................................................. 19-15
19.8.10 Consumables............................................................................................................................ 19-15

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19.8.10.1 ISA Nomoline Family....................................................................................................... 19-15


19.8.11 Maintenance ............................................................................................................................ 19-16
19.8.12 Cleaning the Analyzer ............................................................................................................. 19-16
Chapter 20 IBP Monitoring ............................................................................................................................ 20-1
20.1 Overview ............................................................................................................................................ 20-1
20.2 Precautions on IBP Monitoring .......................................................................................................... 20-1
20.3 Monitoring Steps ................................................................................................................................ 20-2
20.3.1 Zero the Pressure Sensor ............................................................................................................. 20-3
20.4 IBP Setup............................................................................................................................................ 20-4
20.4.1 Pressure Name ............................................................................................................................. 20-4
20.4.2 IBP Overlapping .......................................................................................................................... 20-4
20.4.3 Filter Mode .................................................................................................................................. 20-4
20.4.4 Pressure Scale .............................................................................................................................. 20-5
20.5 Pressure Unit ...................................................................................................................................... 20-5
20.6 Turn on SPV and PPV Display........................................................................................................... 20-5
Chapter 21 Data Review................................................................................................................................. 21-1
21.1 Wave Save .......................................................................................................................................... 21-1
21.2 Trend Review ..................................................................................................................................... 21-1
21.3 NIBP Measurement Review ............................................................................................................... 21-3
21.4 Alarm Event Review .......................................................................................................................... 21-4
21.5 Full-Disclosure Wave Review ............................................................................................................ 21-6
21.6 12-lead Report Review ....................................................................................................................... 21-7
21.7 Patient Event Review ......................................................................................................................... 21-8
Chapter 22 Recording ..................................................................................................................................... 22-1
22.1 Description of Recorder ..................................................................................................................... 22-1
22.2 Recording Types................................................................................................................................. 22-1
22.3 Recorder Operation ............................................................................................................................ 22-2
22.4 Recorder Setup ................................................................................................................................... 22-2
22.4.1 Recording waves Setup ............................................................................................................... 22-2
22.4.2 Paper Speed Setup ....................................................................................................................... 22-2
22.4.3 Real-time Recording .................................................................................................................... 22-3
22.4.4 Timed recording Setup ................................................................................................................ 22-3
22.4.5 Grid.............................................................................................................................................. 22-3
22.5 Load Recorder Paper .......................................................................................................................... 22-3
22.6 Clear Jammed Paper ........................................................................................................................... 22-4
22.7 Recorder Cleaning .............................................................................................................................. 22-4
Chapter 23 Other Functions............................................................................................................................ 23-1
23.1 Connection to Central Monitoring System ......................................................................................... 23-1
23.2 Formatting SD Card ........................................................................................................................... 23-1

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23.3 Analog Output .................................................................................................................................... 23-1


Chapter 24 Battery.......................................................................................................................................... 24-1
24.1 General Introduction........................................................................................................................... 24-1
24.2 Battery Alarms ................................................................................................................................... 24-2
24.2.1 Low Battery Alarms .................................................................................................................... 24-2
24.2.2 Battery Aging Alarms.................................................................................................................. 24-2
24.2.3 Battery Fault Alarms ................................................................................................................... 24-2
24.3 Battery Installation ............................................................................................................................. 24-3
24.4 Conditioning and Check Battery Performance ................................................................................... 24-3
24.5 Battery Recycling ............................................................................................................................... 24-4
Chapter 25 Cleaning and Disinfection............................................................................................................ 25-1
25.1 Overview ............................................................................................................................................ 25-1
25.2 Cleaning of Monitor and Modules...................................................................................................... 25-2
25.3 Disinfection of Monitor and Modules ................................................................................................ 25-3
25.4 Cleaning and Disinfection of Accessories .......................................................................................... 25-3
25.4.1 Cleaning and Disinfection of the External Electrode Paddle....................................................... 25-3
25.4.2 Cleaning and Disinfection of NIBP Cuff..................................................................................... 25-4
25.4.3 Cleaning and Disinfection of Other Accessories ......................................................................... 25-5
25.4.3.1 Cleaning of Accessories........................................................................................................ 25-5
25.4.3.2 Disinfection of Accessories .................................................................................................. 25-5
Chapter 26 Maintenance ................................................................................................................................. 26-1
26.1 Maintenance Check ............................................................................................................................ 26-1
26.2 Maintenance and Test Schedule ......................................................................................................... 26-1
26.2.1 Reusable Accessory Service Life ................................................................................................ 26-2
26.3 Self-test............................................................................................................................................... 26-2
26.4 Shift Exchange Check ........................................................................................................................ 26-3
26.5 Auto Test ............................................................................................................................................ 26-3
26.6 User Test............................................................................................................................................. 26-4
26.6.1 User Test Interface ...................................................................................................................... 26-4
26.6.2 Routine Test................................................................................................................................. 26-5
26.6.3 Energy Delivery Test ................................................................................................................... 26-5
26.6.4 Controls Test ............................................................................................................................... 26-5
26.6.5 Test Result Review ...................................................................................................................... 26-6
26.6.6 User Test Prompt ......................................................................................................................... 26-6
26.7 Recorder Test ..................................................................................................................................... 26-6
26.8 ECG Cable Test .................................................................................................................................. 26-7
26.9 Manual Defibrillation Test ................................................................................................................. 26-7
26.9.1 Charge/ Shock Function .............................................................................................................. 26-7
26.9.2 Disarming Energy........................................................................................................................ 26-7

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26.9.3 Synchronized Defibrillation ........................................................................................................ 26-8


26.10 Pacing Test ....................................................................................................................................... 26-9
26.11 ECG Calibration ............................................................................................................................... 26-9
26.12 NIBP Air Leakage Test .................................................................................................................... 26-9
26.13 NIBP Pressure Verification ............................................................................................................ 26-10
26.14 NIBP Overpressure Protection Test ............................................................................................... 26-11
26.15 IBP Calibration ............................................................................................................................... 26-11
26.16 Electric Safety Test......................................................................................................................... 26-11
Appendix I Accessories................................................................................................................................... I-1
Appendix II Product Specifications ............................................................................................................. II-1
Appendix III Cardiac Rhythm Recognition Test ...................................................................................... III-1
Appendix IV System Alarm Information .................................................................................................. IV-1
Appendix V Factory default configuration ................................................................................................. V-1
Appendix VI EMC....................................................................................................................................... VI-1
Appendix VII Defibrillation Monitor Shift Checklist ............................................................................. VII-1

I-10
Chapter 1 Safety

1.1 Safety Information

Danger

 To indicate the dangers which would result in death or severe personal injury.

Warning
 Alerts you to the situations that may result in serious consequences or endanger personal safety.
Failure to observe the warning information may cause severe injury or even death of the user or
patient.

Caution
 Alerts you to potential dangers or unsafe operations, which, if not avoided, may result in minor
injury, product failure or damage, or property damage, or cause more serious injury in the
future.

Note
 Emphasizes important precautions and provides instructions or explanations for better use of
the product.

Warning
 Before using, you must check the monitor and its accessories to ensure that they can work
normally and safely.
 Do not conduct therapy on patients lying on wet ground.
 When conducting therapy on patients with pacemaker, the pads or paddles should be placed
away from the pacemaker.
 Do not place the power outlet out of the operator’s reach.
 Alarm volume and high/low alarm limits should be set depending on the patient. When a
patient is monitored, do not exclusively rely on the audible alarm system. If the alarm volume
is set too low or is completely turned off, the alarm will not be heard, and the patient may be
put into danger. Pay close attention to the patient’s actual clinical conditions is the most
reliable monitoring way.

1-1
Safety

 The monitor can only be connected to a power outlet with protective ground. If the power
socket is not connected to a ground conductor, use the rechargeable battery to supply power to
the monitor instead of using the power outlet.
 Do not open the housing of the monitor to avoid the potential risk of electric shock. The
monitor must be maintained and upgraded by service technician trained and authorized by
Comen.
 Observe the local laws and regulations or the waste disposal rules of the hospital when
disposing of packaging materials. Keep the packaging materials out of the reach of children.
 Do not use the monitor in the presence of flammable anesthetics or other flammable substance
in combination with air, oxygen-enriched environments, or nitrous oxide.
 To ensure safety, avoid stacking multiple equipment or placing anything on the monitor during
operation.
 Carefully place the monitor power cord and accessories cables to avoid entanglement, potential
strangulation, and electrical interference to the patient.
 To protect you from electric shock, always remove the sensor and completely disconnect the
monitor before bathing the patient.
 For patients with pacemakers, the cardiotachometer may be used to record pacemaker pulse in
the event of asystole or arrhythmia. Donot completely rely on the alarm function of the
cardiotachometer. Patients with pacemakers must be closely monitored. For the pacemaker
inhibiting function of the monitor, please refer to relevant section in this Manual.
 Keep patient under close surveillances when using this monitor to conduct therapy. If the shock
is delayed, the shockable rhythm may change to nonshockable rhythm, leading to delivering
wrong shock.
 The equipment without defibrillation protection shall be disconnected from the patient during
defibrillation.
 During defibrillation, the operator should not come into contact with the patient, the monitor
or the supporting table; otherwise may result in serious injury or death. Before reusing the
cables, check to confirm that their functions are normal.
 Any equipment connected to the monitor shall form an equipotential body (effective connection
of protective ground).
 In order to avoid burns (resulted from electric leakage) to the patient, ensure that the
monitor’s sensors and sensor cables never come into contact with any high-frequency
electrosurgical equipment.
 The physiological waveform and parameter, alarm message and other information displayed
by the monitor are only for reference by physicians, and not directly used as a basis for clinical
treatment.
 Electromagnetic field can affect the performance of the monitor. Therefore, equipment used
near the monitor should conform to the applicable EMC requirements. For example, mobile
phones and X-ray machines are potential sources of interference, since they transmit high-
intensity electromagnetic radiation.

1-2
Safety

 Do not use the monitor during MRI scanning or in a MRI environment as it may result in
physical harm.
 The operator should verify that the synchronous input equipment is applicable to this monitor
and the input signals are valid.
 In normal use, the operator should not touch the signal I/O ports, other live equipment and the
patient simultaneously. This action may result in injury to the patient.
 The installation and replacement of fuse should be performed by service technician trained and
authorized by Comen.
 After defibrillation, the electrocardiogram (ECG) waveform must recover within 5s; other
parameters must recover within 10s.

Caution
 To avoid damage to the monitor, and ensure patient’s safety, use accessories specified in this
manual.
 Handle the monitor carefully to avoid damage caused by drop, collision, strong oscillation or
other external mechanical forces.
 Before powering on the monitor, verify that the supply voltage and frequency conform to the
requirements specified on the monitor nameplate or in this manual.
 At the end of the monitor service life, the monitor and its accessories must be disposed of in
accordance with the local laws and hospital’s regulations.
 Dry the equipment immediately in case of rain or water spray.
 Check the cables, paddle handles and functional accessories periodically for possible defects.

Note
 Place the monitor at a position where observation, operation and maintenance are convenient
and not obstructed.
 This manual is based on the maximum configuration; therefore, some contents may not be
applicable to your monitor.
 Keep this manual available for ease of use and timely reference.
 The monitor is not intended for home use.
 The monitor can only be used for one patient at a time.
 The service life of the monitor is 5 years.

1.2 Contraindications

Unclear

1-3
Safety

1.3 Symbols

Complies with medical equipment


Refer to instruction manual/ booklet CE0197
directive 93/42/EEC

Type CF applied parts, with


European community representative
defibrillation-proof function
Type BF applied parts, with
Equipotential symbol
defibrillation-proof function

AC indicator Network connection symbol

Battery level indicator USB port

Service indicator Multi-function connector

Main menu VGA port

Event Shock button

12-lead ECG IPX4 Ingress protection rating

The environmental protection


Lead select service life of electronic products is
10 years

Static-sensitive device Alarm pause key

Separate collection for electrical and


Serial number
electronic equipment

Warning: Only use the ECG cable


provided by our company. Other
Manufacturer types of ECG cable may decrease
the defibrillation energy delivered
to the patient.

This way up Stacking Layer Limit

Fragile Keep away from rain

Transport and Storage environment Transport and Storage environment


temperature of -20℃~+70℃ humidity 10%~95%

1-4
Safety

Transport and Storage atmospheric pressure of 70kPa~106kPa

1-5
Chapter 2 Overview

2.1 Product Introduction

2.1.1 Intended Use

The Defibrillator Monitor is applicable to manual defibrillation, AED defibrillation, pace-making and vital
sign monitoring on patients.
The expected operator position is about one meter around the monitor in normal use.

2.1.2 Components

The Defibrillator Monitor is composed of main unit, battery, paddles, pads and other functional accessories.

2-1
Overview

2.2 MonitorViews

2.2.1 Front View

Handle

Area 1

Area 4

Area 2 Area 3

2-2
Overview

2.2.1.1 Area 1

3 4

1 Alarm lamps
2 Display
3 AC power Indicator on: this monitor is connected to AC power
indicator supply.
Indicator off: this monitor is disconnected from AC
power supply.
Battery indicator Indicator solid on: battery is being charged.
Indicator blinks: battery is used to supply power to the
monitor.
Indicator off: battery is fully charged, is not installed
or malfunctions.
Service indicator Indicator blinks: The auto test or user test fails
Off: The unit operates properly
4 Soft buttons: one-to-one correspondence to the soft button labels on display screen. The
buttons have different functions under different operating mode.

2-3
Overview

2.2.1.2 Area 2

1
5

1 Record key
2 Speaker: Used to sound an alarm and a language prompt.
3 Record latch lock
4 Paper exit
Red: Recorder error, for example, No paper, Recorder door open,
Error indicator
etc.
5 White: Recorder is powered on
Power indicator Off: An error occurred to the recorder or the recorder is not
installed correctly

2.2.1.3 Area 3

1 8

7
2 6

3 5

2-4
Overview

1 Main Menu Press to pop up or exit the main menu.

2 NIBP Start Press to start or stop NIBP measurement.

3 Alarm Pause Press to pause alarms

4 / Loud Speaker Used to record voices in AED mode

5 Lead Select Press to select lead for the first ECG waveform.

Press to mark some specific events, or to pop up or exit [Event Mark


6 Event
Setup] menu.
Used to select menus and confirm settings; rotate it right or left to
7 / Rotary Knob
move the cursor and press it to select.

8 12-lead Press to enter or exit 12-lead screen in monitor mode.

2.2.1.4 Area 4

1 Mode Selector: Rotate to switch operating mode, including AED, Pacer, Monitor, Manual
defibrillation and OFF mode, and select energy level in Manual defibrillation mode. The
monitor will shut down when in OFF position for about3s.
2 Energy Select button: Press ―-‖ and ―+‖ to decrease and increase energy level respectively
in manual defibrillation mode.
3 Charge button: Press to charge the defibrillator.
4 Shock button: Press to deliver defibrillate or energy to patients

2-5
Overview

2.2.2 Right View

Therapy cable connector

2-6
Overview

2.2.3 Left View

External electrode paddle Handle

Hook

Battery

Sensor connectors

ECG connector SpO2 connector

TEMP1 connector

CO2 connector IBP1 connector

TEMP2 connector

NBIP connector IBP2 connector

2-7
Overview

2.2.4 Rear View

Hook

USB connector
Battery1
Net connector

Multi-function
connector

Battery 2
VGA connector

Equipotential
Power connector
connector

1. Equipotential connector: When the monitor is used together with another equipment, use a wire to
connect the equipotential terminals of the monitor with that equipment. This eliminates the ground
potential difference, thus ensuring the safety.
2. USB connector: supporting USB equipment (plug and play).
3. Network connector: connecting to the central monitoring system or other equipment by a network cable.
4. Multi-function connector:

1. Used as defibrillation synchronization port: inputting defibrillation synchronization signal;

2. Used as analog output port: outputting analog signals;


5. VGA connector: Connecting to the display with standard VGA port for showing the current monitoring
information.

Warning
 Only the approved analog or digital equipment in accordance with the specified IEC standards
(like IEC 60950 safety standards for Information Technology Equipment, IEC 60601-1 safety
standards for medical electrical equipment, etc.) are allowed to be connected to the monitor. All

2-8
Overview

configurations should comply with the valid version of the standard IEC 60601-1.Personnel who
connects external equipment to the signal I/O ports of the monitor should verify that medical
system complies with IEC 60601-1 requirements, before configuring the medical system and
connecting the external equipment.
 In normal use, the operator should not touch the signal I/O ports, other live equipment and the
patient simultaneously. This action may result in injury to the patient.
 If more than one external equipment is connected to the monitor at one time through the patient
cable connector, network connector or other signal ports, the total leakage current should be in
accordance with the requirement specified in IEC 60601-1.

2.2.5 External Defibrillation Electrode Paddle

Shock indicator
Shock key Shock key
Energy select key Charge key

Apical electrode
Sternal electrode Electrode paddle handle paddle
paddle

2.3 OSD (On-screen Display)

This monitor uses a backlight LCD color screen which can simultaneously display:
 Physiological parameters,

 Waveforms,

 Alarm message,

 Time,

 Battery level,

 Prompt messages, and so on.

2-9
Overview

2 3 4 5 6

8 12 9
7

11

7
1

10 9 8
1

1. Patient information area: Display the patient type (adult, pediatric and neonate),pacemaker status, and

name. Select the patient info to enter the [Patient Manage] menu.
For patients with pacemakers, when [Pace] (Pacemaker) in the [Patient Info] menu is enabled, icon is

shown at the upper right corner of this area; when [Pace] (Pacemaker) is disabled, icon is shown at the

upper right corner of this area.


2. Time: Shows the current configured time of the monitor. You can enter the [Main Menu] → [Maintain] →

Enter Password → [Time Setup] menu to reset the system clock according to your local time zone.

3. Prompt icons:

Alarm Pause icon ,

Alarm volume off icon .

Alarm system off icon

4. Technical alarm message:

Display the current technical alarm (for example: ECG LEAD OFF). When there are multiple technical

alarms, alarm messages scroll in a cycle. Select the technical alarm message area to enter the [View

Technical Alarm] window.

2-10
Overview

5. Physiological alarm message:

Display the current physiological alarm (for example: ***RR TOO HIGH). When there are multiple

physiological alarms, alarm messages scroll in a cycle. Select the physiological alarm message area to

enter the [View Physiology Alarm] window.

6. Battery status icon: Indicate the status of two batteries. Refer to Battery for detail.

7. Parameter Area

 Display the measured value and the set alarm limit of each physiological parameter.

 The parameter is displayed as the same color with the corresponding waveform.

 Select a parameter to open the corresponding setup menu.

For details on the layout of this parameter area, see Section 5.5.6 Screen Setup.

8. Soft Button Labels

These three labels are one-to-one corresponding to the three soft buttons below them. They will vary with

different operating modes and display screens. Blank label indicates the corresponding soft button is

invalid.

9. Status Message Area

Display status message and prompt message.

10. Elapsed Time

Display the operating time after this monitor starting up.

11. Manual Defibrillation Message Area

Display the energy selected, shock times and relative prompt message.

12. Waveform Area

Display the measurement waveforms with the waveform name at the left top corner.

2.4 Operating Mode

The Defibrillator Monitor is applicable to pre-hospital and in-hospital use and must only be used by qualified
medical personnel who have received enough operation training, basic life support training and advance
cardiac life support training.
The monitor supports four operating modes, including manual defibrillation mode, monitor mode, pacer mode
and AED mode.

2-11
Overview

2.4.1 Manual Defibrillation Mode

In manual defibrillation mode, operators analyze patient’s cardiacrhythm and operate following the steps
below according to needs:
1. Select manual defibrillation mode and adjust energy level if necessary;
2. Charge the defibrillator;
3. Shock.
Synchronized cardioversion is also provided in manual defibrillation mode.
Manual defibrillation is applicable to patients suffering from ventricular fibrillation and ventricular
tachycardia and without respiration and pulse; synchronized cardioversion is used to stop atrial fibrillation.
Contraindications
Do not conduct manual defibrillation on patients of any kind below:
 With response
 With autonomous respiration
 Can touch the pulse

2.4.2 Monitor Mode

In monitor mode, the Defibrillator Monitor is applicable to adult, pediatric and neonate bedside monitoring
and can be used to monitor, display, store, review and transfer multiple physiological parameters including
ECG, RESP, TEMP, SpO2, NIBP, IBP and CO2.

2.4.3 Pacer Mode

Pacer mode provides noninvasive pacing therapy. Noninvasive pacing is used to conduct therapy for
bradycardia patients.
Contraindications
Noninvasive pacing cannot be used for ventricular fibrillation therapy. Noninvasive pacing should be used
with cause in case of hypothermia.

2.4.4 AED Mode

In AED mode, the Defibrillator Monitor analyzes patient’s cardiac rhythm automatically and gives ―Shock
Advised‖ or ―No Shock Advised‖ prompts. What’s more, the Defibrillator Monitor can guide operators to
conduct defibrillation through voice prompt and display prompt message on the screen as well.
AED is applicable to sudden cardiac arrest patients of the following kinds:
 Without response
 Without respiration or Not breathing properly

2-12
Overview

Only conduct defibrillation on children below 8 years old in manual defibrillation mode.
Contraindications
Do not conduct AED on patients of any kind below:
 With response
 With normal respiration

2-13
Chapter 3 Installation

Warning
 The Defibrillator Monitor must be installed by the personnel specified by Comen.
 With copyright reserved, any person shall not falsify, photocopy or exchange the software in any
manner whatsoever without prior written permission of Comen.
 When the Defibrillator Monitor is connected with other electrical equipment as a combination
with specific function, if users could not confirm the combination has no danger (for example,
the electric shock hazard caused by the accumulated leakage current) from the specifications of
each equipment, please contact the specialist of Comen or the hospital to ensure the combination
is safe.
 Only the analog or digital equipment compliant with the specified IEC standards (like IEC
60950 standard for data processing equipment, IEC 60601-1 standard for medical equipment,
etc.) are allowed to be connected to the Defibrillator Monitor. The configuration of these
equipment should comply with the valid version of IEC 60601-1 standard. The person who
connects external equipment to the signal I/O interface should configure the medical system and
ensure the medical system complies with IEC 60601-1 standard. If you have any question, please
contact Comen.

3.1 Unpacking and Checking

Carefully take the monitor and its accessories out of the packing box and check according to the following
aspects.
1. Check whether all accessories are provided according to the Packing List.

2. Check for damage.

3. Check all exposed lead wires and connectors.


For any problem or inconsistencies, contact Comen or your distributor
Keep the packaging materials for future use.

Warning
 This equipment may suffer from microbial contamination during transport, storage or use.
Please check whether the packaging is intact, especially for the disposable accessories, and do
not use those with any damage.
 The disposal of packaging materials shall comply with the local laws and regulations or the
waste disposal rules and regulations of the hospital. Keep the packaging material out of the
reach of children.

3-1
Installation

3.2 Connection of AC Power Cord

Before powering on the monitor, verify that the supply voltage and frequency conform to the requirements
specified on the monitor nameplate or in this manual. The steps of connecting the AC power cord:
1. Using the power cord that came with the instrument, connect one end of the power cord to the power
connector on the instrument and the other end to a grounded electrical outlet.
2. Check if the AC indicator is lit. The indicator lights up when the AC power is turned on.

Note
 Connect the power cord to specific hospital outlet.
 When a battery is provided, the battery must be charged after transportation or storage. If the
battery is low, the monitor may fail to work without connecting an AC power supply. Once the
monitor is connected to an AC power outlet, the battery will be charged whether the monitor is
switched on or not.

Connect the equipotential conductor when necessary. Please refer to the content about equipotential grounding
in the ―Patient Safety‖.

3.3 Start-up

1. Before power on, please check whether there is mechanical damage on the Defibrillator Monitor and
whether the external cables and accessories are connected correctly.
2. Insert the power cord into AC power supply socket. If battery is used to supply power, make sure that
there is adequate battery power.
3. Rotate the mode selector to the desired operating mode. First the left alarm lamp turns red and right turns
cyan, and then left turns yellow and right turns blue.
4. Startup picture disappears and the Defibrillator Monitor enters the selected operating mode.

Warning
 If any evidence of failure or any error message is found, do not use this monitor. Contact a
service technician of Comen or a biomedical engineer in your hospital.

Note
 The system sounds an alarm when a major error is detected in the self-test.
 Check all monitoring functions to ensure that the monitor can operate normally.
 The battery must be charged after each use to ensure that sufficient battery power is available.
 To extend the service life of the monitor, after shut-down, wait for at least 1 minute before
restarting the monitor.

3-2
Installation

3.4 Connecting the Sensor or Patient Cable

Confirm what kind of monitoring or treatment is needed and connect the required sensor or patient cable to
the monitor and the patient's monitoring site. Please refer to the relevant sections for the correct connection
method and related requirements for various sensors and patient cables.

3-3
Chapter 4 Patient Safety

4.1 Safety Instructions

The monitor is designed in accordance with international safety standards for medical electrical equipment. It
is provided with defibrillation-proof and electrosurgical protection with floating ground input.

4.2 Environmental Requirements

Before powering on the monitor, verify that the supply voltage and frequency conform to the requirements
specified on the monitor nameplate or in this manual.
The monitor should be used in an environment that can reasonably avoid vibration, dust, corrosive or
explosive gases, extreme temperature and humidity, etc.
When the monitor is installed in an enclosed space, make sure the space is well ventilated. Leave at least 2
inches (5cm) free space around the monitor for air circulation. Also, leave sufficient space around it for easy
operation and maintenance.

4.3 Protective Grounding

To protect both the patient and the operator, the housing of the monitor must be grounded. The monitor is
equipped with a detachable 3-wire power cord, which shall be inserted into a grounded power outlet to ensure
that monitor is grounded. If grounded power outlet is not available, contact the maintenance department in
your hospital.

Warning
 It is NOT recommended to connect the 3-wire power cord to a 2-wire power outlet.

Connect the ground wire to the equipotential connector of the monitor. If you have doubt about whether
equipment used may cause any electrical risks, such as risk caused by accumulation of leakage current,
consult an expert in this field to ensure the safety of all equipment.

4.4 Equipotential Grounding

The monitor must be connected to a power outlet with protective grounding. For cardiac or cerebral
examination, the monitor must be connected to a standalone equipotential grounding system. Connect one end
of the equipotential conductor (potential equalization conductor) to the equipotential connector on the rear

4-1
Patient Safety

panel of the monitor and the other end to a connector of the equipotential grounding system. In the event the
protective grounding system is damaged, the equipotential grounding system can provide protection to the
patient and operator.
Cardiac (or cerebral) examination can only be performed in a room installed with a protective grounding
system. Before each use, ensure the monitor is in a normal operating status. Cables connecting the patient to
the monitor must not be contaminated by electrolyte.

Warning
 If the protective grounding system is not stable, use the built-in battery to supply power to the
monitor.

Note
 If the use of the equipment is affected by the equipotential grounding, contact the Company’s
After-Sales Service Department or agents.

4.5 Condensation

Ensure that the monitor is free from condensation during operation. When the monitor is moved from one
room to another, condensation may be formed due to exposure to damp air and temperature difference. In this
case, do not use the monitor until it is dry.

4-2
Chapter 5 Basic Operations

Note
 The distance between the operator and the monitor should be less than 1 m so that the operator
can observe the monitor easily.

5.1 Enter Main Menu

In pacer, monitor and manual defibrillation mode, press key on the front panel to access [Main Menu] and

perform operations and settings. In AED mode, the key is unavailable.

1. key: Press this button to exit the current menu.

2. , key: Page up/down.

5.2 Enter User Maintain Menu

Enter [Main Menu] → [Maintain]. Enter the correct password in the pop-up [Password] dialog to enter the
[User Maintain] menu.

5-1
Basic Operations

5.3 View Monitor Info

Enter [User Maintain] → [Monitor Info] (Monitor Information). Monitor info includes software and hardware
version, etc., which facilitate the manufacturer to maintain and trace the monitor.

5.4 Enter Parameter Setup Window

Enter the setup windows by one of the following ways:


 In the waveform area: Select a waveform and the corresponding setup window will display. For example,

you can select ECG waveform to open the [ECG Wave] window.

 In the parameter area: Select a parameter and the corresponding setup window will display. For example,

you canselect the ECG parameter area to open the [ECG Setup] window.

 In the [Measu. Setup] menu: Enter [Main Menu] → [Measu. Setup]) to open the [Measu. Setup] window.

You can select and set the desired parameter.


After entering the setup windows, you can set parameters displayed on the screen.

5.5 General Setup

5.5.1 Time Setup

Enter [User Maintain] → [Time Setup]. Set the system time according to the local time zone, including Year,
Month, Day, Hour, Minute (Min), Second (s), Date Format, and Time Format. The settings become effective
immediately.

5.5.2 Language Setup

Enter [User Maintain] → [Language]. Select the user screen language that you want.

5.5.3 Measurement Unit Setup

Enter [User Maintain] → [Unit Setup]. Set the units you want to use for parameters, including [Height Unit],
[Weight Unit], [Press. Unit] (Pressure Unit), [CVP Unit], [Temp Unit] and [CO2 Unit].

5-2
Basic Operations

5.5.4 Brightness Setup

1) Enter [Main Menu] → [Screen Config] (Screen Configuration) → [Brightness].

2) Select the appropriate brightness in X~100. 100 indicates the brightest, and X indicates the darkest (X

refers to the factory default setting, generally 10).

5.5.5 Keys Backlight Setup

In dark environment, you can turn on keyboard backlight. To configure:


1) Enter [Main Menu] → [Screen Config] → [Key Light].

5.5.6 Screen Setup

Enter [Main Menu] → [Screen Config] → [Screen Layout]. In this window, you can adjust the position of
waveforms and parameters. Only parameters that have been turned on are shown on the screen.

Area 1: Waveform area: You can choose to display the parameters and their waveforms (if one exists).The
first row of this area always shows the first ECG waveform and parameter. Waveforms are displayed on the
left and parameters on the right. The waveform and its corresponding parameter are shown on the same line.
Area 2: you can choose to display the parameters. But if a particular row in the area 3 has no parameter, the
corresponding row in area 2 will display parameters and waveforms at the same time.
Area 3: Parameters without waveform: Only data are displayed for parameters in this area.

After layout setup, select to exit.

5-3
Basic Operations

5.5.7 Volume Setup

QRS Volume characteristic: beep


Beat Volume characteristic: beep
Enter [Main Menu] → [Volume Setup].
1) Select [Alm Vol] (Alarm Volume): Select the appropriate volume level between X (the lowest volume,

which depends on the setting of the Minimum Alarm Volume) and 10 (the loudest volume). Refer to the

“Alarms” chapter for details;

2) Select [QRS Vol.] (QRS Volume): Select the appropriate volume within 0~10;

3) Select [Beat Vol]: Select the appropriate volume within 0~10;

4) Select [Key Vol]: Select the appropriate volume within 0~10.

5.5.8 Waveform Freeze

In the Monitor mode, select the [Freeze] soft key, then all waveforms on the screen stop refreshing or
scrolling and the [Freeze] menu pops up, while the parameter area remains refreshing properly, as shown
below.

In the [Freeze] window, use the rotary knob to select the forward or backward key and then rotate the

knob to move the frozen waveform leftward or rightward. A down arrow is shown on the right side above the

top waveform, with a time scale displayed to the left of the arrow. The freeze time is marked as [0s ]. With

the leftward movement of the waveform, the time scale will change to [-1s ], [-2s ], [-3s ]... in sequence,

indicating that how many seconds the waveform has been frozen.
Record Frozen Waveform
In the [Freeze] window, select the waveform you want to print ([Wave1], [Wave2], [Wave3] and [Wave4])
and click the Record key. The recorder prints the frozen waveform and value.
Unfreeze
Click to exit.
Press the Freeze key on the front panel again.

5-4
Basic Operations

Press the Freeze Soft Button again.

5.5.9 Event Setup

Event setup involves saving waveforms for manually triggered events. During patient monitoring, the
occurrence of some events may have certain impacts on the patient, resulting in changes in some waveforms
or parameters. You can select manually triggered events in [Manual Trigger] settings. When an event is
triggered, the monitor marks it and saves the corresponding waveforms and value. You can review the event
later to analyze its impacts. To configure:
1) Enter [Main Menu] → [Event Setup]→ [Event Marker Setup].

2) Choose 3 waveforms from the available options as [Event Save Waves] and mark event: [EVENT A]:

Default general event, which cannot be set by the user. [EVENT B/C/D/E/F/H]: the following events can

be selected: [Epinephrine], [Lidocaine], [ATROPINE], [Nitroglycerin], [MORPHINE], [CANNULA],

[VENOUS TRANSFUSION], [ADENOSINE], [AMIODARONE], [VASOPRESSIN], [Isuprel],

[Dopamine], [ASPININ], [OXYGEN] and [CPR].

3) Users can also set custom events 1, 2, 3 and 4 as needed.

4) After the event setting is completed, select the event tag button on the panel to enter [Event Marker

Setup], select the event to be triggered, and press the shuttle.


In AED mode, pressing the [Event] button will directly mark event A as a [General] event.
To review a manually triggered event, select the event in the [View Physiology Alarm] menu under [Alarm
Event Review].

5.5.10 Module Switch Setup

You can turn on/off the parameter modules as needed. When a parameter module is turned off, the
corresponding waveform and parameter are not displayed on the screen, and the monitor stops measurement,
analysis and alarm for that module.
1) Enter [User Maintain] → [Module Setup].

2) Turn on/off a parameter in the setup menu.

5.5.11 User Password Setting

You can set the password for entering the [User Maintenance] according to your own needs.
1) Enter [User Maintain] → [Set User PassWord].

5-5
Basic Operations

5.5.12 High Contrast Display

High contrast display is helpful for operators to view the contents displayed on the screen in the environment
with strong light.
In pacer, monitor and manual defibrillation mode, enter [Main Menu], select [High Contrast] and enter high
contrast display with [High Contrast] turning to [Normal] simultaneously. Select [Normal] to exit high
contrast display.
In AED mode, press [High Contrast] soft button to enter high contrast display and press [Normal] soft button
to exit the high contrast display.
The high-contrast display is turned on in one mode of operation, and the high-contrast display is maintained
when switching to other clinical modes, but the system no longer saves the settings after shutdown.

5.5.13 Demo

Enter [User Maintain] → [DEMO] to put the monitor into demonstration mode.

Warning
 Demo waveforms are used to simulate the actual monitoring process. Demo mode can only be
used to demonstrate the monitor performance and assist in training course. In actual clinical
use, it is NOT recommended to use the demo mode, because the users/operators may mistake
the demo data for waveforms and patient parameters which can put patient safety at risk.

5-6
Chapter 6 Patient Management

You can enter the [Patient Manage] menu in one of two ways:
a) Enter [Main Menu] and select [Patient Manage];
b) Click in the patient info area on the upper menu bar.

6.1 Admit

When a patient is connected to the monitor, the monitor displays and saves the patient’s physiological data
even if the patient is not admitted. But correct patient admission is important for patient monitoring.
You can admit and discharge a patient in the [Patient Manage] window.
To admit a hospitalized patient:
1) Enter [Patient Manage] → [Admit].

2) If another patient has been admitted on the monitor, the prompt message [Discharge current patient?

Admit new patient?] is shown. Select [Yes] to discharge the existing patient. If no patient has been

admitted, the prompt message [Apply the monitoring data to the patient to be admitted?] is shown.

 [Yes]: Apply the monitor data to the new patient.

 [No]: Clear the stored data on the monitor.

3) Enter patient info in the [Patient Info] menu. Pay attention that [Pat Type] (Patient Type) and [Pace]

(Pacemaker) are set correctly. You can use keyboard to enter information.

 [Pat Type]: the options include [Adu] (Adult), [Ped] (Pediatric), [Neo] (Neonatal). It is essential to

select the correct patient type, as it determines the algorithm used to compute and process the

patient data, as well as certain safety limits and alarm limits applied to the patient.

 [Pace]: This setting determines whether the monitor displays pacemaker pulse. When [Pace] is set to

[ON] and pacemaker signal is detected, symbol is shown above the ECG waveform, and is

shown at the upper right corner of the message prompt area. When [Pace] is set to [OFF], no prompt

message or symbol is displayed, and pacemaker pulse is filtered out.

Warning
 Whether a patient is admitted or not, the monitor assigns a default value to both [Pat Type]
and [Pace]. Make sure the settings in [Patient Info] are consistent with the patient’s actual
conditions before monitoring.
 When the patient type is changed, the system loads the factory default configuration. Verify

6-1
Patient Management

the alarm limits before patient monitoring to ensure that these alarm limits suit your patient.
When the patient type is not changed, the current configuration is not changed.
 For the patient without pacemaker, [Pace] must be set to [OFF]. Otherwise, the system cannot
detect arrhythmia related to ventricular premature beats (including PVCs count), and ST
segment analysis will not be carried out.
 If the patient is admitted with a pacemaker, [Pace] should be set to [ON]. Otherwise,
pacemaker pulse may be counted as normal QRS wave, resulting in failure to detect the [ECG
Lost] alarm.

6.2 Quick Admit

The [Quick Admit] mode can be used in emergency situation when there is not enough time to fill in patient
information. However, you must complete the patient info later.
1) Enter [Patient Manage] → [Quick Admit].

2) If another patient has been admitted on the monitor, the prompt message [Discharge current patient?

Admit new patient?]is shown. Select [Yes] to discharge the existing patient. If no patient has been

admitted, the prompt message [Apply the monitoring data to the patient to be admitted?] is shown.

 [Yes]: Apply the monitor data to the new patient.

 [No]: Clear the stored data on the monitor.

3) Enter the [Patient Info] window, set [Pat Type] and [Pace], and then close the window.

6.3 Discharge

To discharge a patient from the monitor:


1) Enter [Patient Manage] → [Discharge].

2) The system shows the prompt message [Discharge?].

 [Yes]: Discharge the current patient. The original patient data will be archived automatically if the

monitor is mounted with a SD card. You can review the archived patient data in [Document

Manage].

 [No]: Cancel the discharge operation.

Warning
 After the patient is discharged, [Pace] will be automatically set to off.

6-2
Patient Management

6.4 Document Manage

You can inquire, review, delete and export archived patient files in [Document Manage]. However, patient
data cannot be archived if the monitor is not installed with a SD card.
[Query]: Enter the patient name in the field at the lower left corner of the [Document Manage] window and
click [Query] to search for the patient’s file.
[View]: Select the patient info bar you want to review. Click [View] to open [Review] menu, in which you
can view [Patient Info], [Trend Review], [NIBP Review], [Alarm Event Review], [Wave Review] and [Patient
Event Review].
[Delete]: Delete the selected patient file.
[Export]: Export the selected patient file to a USB flash drive.

To manage patient file, do the followings:


1) Enter [Main Menu] →[Document Manage].

2) Enter a patient name in the input field at the lower left corner of the window.

3) Click [Query] the show the patient files found.

If there are multiple patient files found, click the keys to select the one you want to view; click the

keys to show more information of the patient.


4) You can [View], [Delete] and [Export] the selected patient file.

5) If you check the box at the lower left corner, all patient files are selected. At this time, you can click

[Delete] to delete all patient files.

6) You can export patient files by following these steps:

 If a single patient file is selected, select [Export] to open the [Data Export] menu.

1) Set the [Start Time] and [End Time].

2) Select [File Format]: options are .bin or .txt.

3) Select [Export Media]: options are USB or FTP.

4) USB: Export to a USB flash drive.

5) FTP: Export to a FTP server by wired network.

6) Select [Data Export] to start export. When it is finished, the prompt message [Data export

succeeded, please restart.] is shown.

 If multiple patient files are selected, operations steps are the same with those for single patient file

except that [Start Time] and [End Time] cannot be set.

6-3
Patient Management

Warning
 Patient alarm messages, physiological and technical alarms are saved in the patient file.
 In the event of a power interruption, alarm events are still saved in the patient file.
 When exporting data to a USB drive, do not remove the USB drive until the export process is
completed in order to prevent data corruption.
 When exporting data to an FTP server, do not disconnect the network cable until the export is
completed, in order to prevent data corruption.

Note
 When the monitor is shut down, the data in the monitoring period before the shutdown is
saved automatically. Upon start-up of the monitor, the system automatically creates a new
period (i.e., current period data).
 The monitor allows data storage upon power failure.

6.4.1 Save Tactics

The monitor creates a patient file and save its data even if no patient has been admitted. Such patient file is an
unowned temporary case (Temp Case), which can be automatically deleted. Also, the monitor can
automatically delete old cases when the SD card is full.
To automatically delete the unowned case and old case, do the followings:
1) Enter [User Maintain] → [Save Tactics];

2) Select [Auto Del Temp Case] and [Del old case] respectively, and switch them between [ON] or[OFF].

6-4
Chapter 7 Configuration Management

To enter the [Config Manage] menu:

1) Select [Main Menu].

2) Select [Config Manage], and enter the password.

7.1 Department

The department in which the monitor is used. When Department is modified, all user configuration files of the
previous department are deleted. Each department has 3 factory default configurations, i.e. ADU (Adult), PED
(Pediatric), NEO (Neonatal). At most 3 user-defined configurations can be saved to the current department
configuration directory. Before managing the configuration, ensure that the correct department is selected.
Department options: General (General Monitoring)
OR (Operation Room/Anesthesia Monitoring)

ICU (Intensive Care Unit)

NICU (Neonatal Intensive Care Unit)


CCU (Coronary Care Unit)

Note
 Upon start-up or before admitting a new patient, you need to check the current configuration
of the monitor. This can be viewed in [Load Config]. The configuration name marked with the
symbol —> in front is the currently loaded configuration.
 Make sure the configuration you select is appropriate for the patient being monitored.
 Use of different configurations on the monitor in the same department (e.g., ICU or Cardiac
OR) may put patient safety at risk.
 The monitor automatically loads the corresponding default factory configuration when you
switch to another department or change the patient type.
 The monitor can memorize system configuration.

7.2 Manual Defibrillation Settings

Manual defibrillation settings include the following items:


 [External Defib Energy]: set the default energy for external manual defibrillation. The available energy
level includes 2J,5J, 10J, 50J, 100J, 150J, 170J, 200J and 300J.
 [Internal Defib Energy]: set the default energy for internal manual defibrillation. The available energy

7-1
Configuration Management

level includes 2J, 5J, 10J, 20J, 30J and 50J.


 [Auto Disarm Time]: set the time to energy auto disarm, including 30s, 60s, 90s and 120s. If the shock
button is not pressed for discharge within the set time, the defibrillation monitor will automatically
release the energy.
 [Sync Keep]: switch [ON] or [OFF]. [ON] means the monitor is still in synchronized cardioversion mode
after a synchronized shock. [OFF] means the monitor will auto exit synchronized cardioversion mode
after a synchronized shock.
 [Remote Sync Input]: switch [ON] or [OFF] to activate or deactivate the remote synchronized
cardioversion function respectively.
 [Charge Tone Vol]: adjust the charge tone volume. Available volume level includes [High],
[Med]and[Low];
 [Contact Imped Prompt]: toggle between [ON] and [OFF].[ON] means there will be contact impedance
indicator displayed in manual defibrillation mode.

7.3 AED Settings

AED settings include the following items:


 [Serial Shock Times]: set the serial shock times, including 1,2 and 3. When the mode is switched back to
AED mode, the number of electric shocks is cleared and recalculated, and the electric shock energy is
counter from the last energy before switching.
 [First Shock Energy]: set the energy for the first shock. Available energy level includes 100J, 150J, 170J,
200J, 300J and 360J.
 [Second Shock Energy]: set the energy for the second shock. Available energy level includes 100J, 150J,
170J, 200J, 300J and 360J. Not lower than the first shock energy.
 [Third Shock Energy]: set the energy for the third shock. Available energy level includes 100J, 150J,
170J, 200J, 300J and 360J. Not lower than the second shock energy.
 [Auto Disarm Time]: set the time to energy auto disarm, including 30s, 60s, 90s and 120s.
 [Pre-Shock CPR Time]: set the pre-shock CPR time, including OFF, 30s, 60s, 90s, 120s, 150s and 180s.
 [CPR Time]: select the CPR duration, including 30s, 60s, 90s, 120s, 150s and 180s.
 [CPR Metronome]: switch [ON] or [OFF] to activate or deactivate the CPR metronome function
respectively.
 [CPR Mode]: select the CPR mode, including [30: 2], [15:2] and [Only Press].
 [NSA Process Mode]: select the NSA process mode, including [Continue Analysis] and [CPR].
 [Voice Prompt]: switch [ON] or [OFF]. [ON] means there will be voice prompt to guide defibrillation in
AED mode.
 [Voice Volume]: set the volume of voice prompt in AED mode, including [High], [Med] and [Low].
 [Voice Interval]: set the interval of voice prompt in AED mode, including close, 30s, 60s, 90s, 120s, 150s
and 180s.

7-2
Configuration Management

 [Audio Recording]: switch [ON] or [OFF] to activate or deactivate the audio recording function in AED

mode respectively.

7.4 Pacer Settings

Pacer settings include the following items:


 [Pace Rate]: select the default pacing rate from 40ppm to 170ppm.
 [Pace Elec]: select the default pacing current from 0mA to 200mA.
 [Pace Mode]: select the default pacing mode from [Demand Pace], [Fixed Pace].

7.5 12-Lead Settings

 [Report Format]: select the report format of 12-lead ECG, including 3×4 and 4×3.

7.6 Save as User Config

You can save the current configuration as a user configuration after entering a configuration name. The
configuration name can consist of alphanumeric characters or underscore (_), but cannot be empty. If the
name you have entered is already used by another configuration, the message [Overwrite config with same
name] will display on the screen. The monitor can save up to 3 user configurations.

7.7 Delete Config

Delete user configurations currently saved in the monitor. In this menu, all user configurations saved under
the current department are listed, with patient type in brackets added after each configuration name. For
example, John (ADU) indicates that the configuration ―John‖ is saved when the patient type is ADU.

7.8 Load Config

The monitor supports up to 6 configurations for one department. Configurations available for loading include
the default factory configurations for the current patient type, user-defined configurations, and configurations
imported from the USB flash drive. Patient type is marked after the user-defined configuration name. After
you load configurations, it replaces the current configurations and become effective.

Enter [Load Config]: enter [Main Menu] or [Config Manage] → [Load Config].

7-3
Configuration Management

7.9 Import Config from USB

You can import configurations from a USB flash drive if there are less than 6 configurations for the current
department.

7.10 Export Config to USB

Export user-defined configurations in the system to a USB flash drive.

7.11 Startup Configuration

You can set the configuration adopted by the monitor when it restarts.
But after the monitor powers off, the configurations are set according to the following rule: If restarted within
120s after powering off, the monitor automatically uses the latest configurations; if restarted 120s later after
powering off, the monitor uses the configurations according to [Startup Configuration].

7.12 Record Settings

Record settings include the following items:


 [RT Record Time]: set the real-time record time.
 [Paper Speed]: set the paper speed.
 [Actual Charge Energy]: switch [ON] or [OFF]. [ON] means the actual delivered energy will be recorded
on record paper when recording shock events.
 [Grid]: switch [ON] or [OFF]. [ON] means recording with grid.
 [Auto Record]: the following reports and events will be recorded automatically when they are triggered if
they are set to [ON]: [Charge Event], [Shock Event], [User Event], [12-Lead Report] and [Auto Check
Report].

7.13 Test Settings

 [User Test Prompt]: switch [ON] or [OFF]. [ON] means the monitor will give a prompt when the user
test is overdue.
 [Auto Test Time]: set the time when the monitor conduct daily auto test. Available test time includes
0:00, 1:00, 2:00, 3:00, 4:00 and5:00.

7-4
Configuration Management

7.14 Network Settings

In this menu, users can set the network bed number, IP address, subnet mask, server IP, Server Port, Gateway
and MAC address.
When the connection is successful, the message prompt area at the bottom of the screen prompts [CMS
Connected]. See "Connection to Central Monitoring System" for details.

7-5
Chapter 8 Monitor Screen

This monitor provides two user screens in monitor mode: standard screen and 12-lead screen. User can get
different screen messages from different screens.

8.1 Standard

Standard screen can display waveforms of up to 5 channels with separate parameter display area based on the
maximum configuration. The waveform on each channel is not fixed and you can change the position of each
waveform as needed.
Switch to monitor mode and open the standard screen as shown below:

On standard screen, the three soft button labels are [Freeze], [Review] and [Alarm Reset].

8.2 12-lead Screen

12-lead screen can display ECG waveforms of 12 leads, including I, II, III, AVR, AVL, AVF, V1, V2, V3, V4,
V5 and V6, applicable to comprehensive observation of ECG waveforms when the lead type is 12-lead. Under
this interface, the monitor only provides diagnostic filtering mode.

In monitor mode, press the (12 Lead) key on the front panel to enter the 12-lead screen, as shown below:

8-1
Monitor Screen

Under the 12-lead screen, ECG data can be collected and analyzed, and ECG diagnostic reports can be output.
The patient information can be modified in the 12-lead screen. Select the [Patient Info] softkey to enter the
[Patient Info] menu for modification.
Under the 12-lead ECG monitoring screen, select the [Collect] soft key to collect the patient's ECG waveform.
At this time, the screen pops up the message ―Acquiring Ecg......, Keep Ecg electrodes connected properly‖.
Collect the ECG signal for 10s, then the screen pops up "Analying Ecg......, please keep the lead connection
normal". After about 10 seconds of analysis, a diagnostic report is output. Keep the patient still during the
collection of the signal.
All diagnostic reports are automatically saved in the [12-lead Report Review] window. See the Section 12-
lead Report Review for details.
To exit the 12-lead interface, press the button on the lower shell again, select the [Exit] soft key or set the
[Lead Type] to [3 Leads] or [5 Leads].

Warning
 Keep patient still while acquiring 12-lead ECG data, or the accuracy of ECG data will be
affected.
 If the monitor is put in a mobile vehicle, please stop the vehicle when acquiring12-lead ECG
data.

Note
 [Lead Select] on the panel is not selectable when the 12-lead screen is displayed.
 When gathering 12-lead ECG signal, only [Alarm Pause], [12-Lead] and record button on the
panel can be activated.

 When the device is powered by AC, [Noth Filter] should be set as [on] to avoid interference on

8-2
Monitor Screen

gathering and displaying 12-lead ECG waveform.

8.3 Set Screen Style in Monitoring Mode

You can set the screen style as needed, such as:


1) Wave sweep speed.

2) Wave style.

3) Color of parameters and waves displayed.

4) Parameters shown on the screen.


You can set the screen style for all parameters using the same method described in this section.

8.3.1 Set Wave Sweep Speed

1) In the [Standard] screen, select the waveform. For example: Select the ECG wave [II] or [I] → [ECG

Wave] → [Sweep].

2) Select the appropriate sweep speed.

8.3.2 Set Wave Style

Enter [User Maintain] → [Wave Type] → [Thin],[Med] (Medium) or [Bold].

8.3.3 Set Module Color

1) Enter [User Maintain] → [Module Color].

2) In the [Module Color] menu, you can select a waveform and set its color to: [Red], [Orange], [Yellow],

[Green], [Cyan], [Blue], [Purple] or [White].

8.3.4 Set Wave Draw

Enter [User Maintain] → [Wave Draw] → [Color], [MONO].

8.3.5 Set Wave Fill

1) Enter [User Maintain] → [Wave Fill Setup].

2) Select the parameter as needed.

8-3
Monitor Screen

8.3.6 Change Screen Layout

Enter [Main Menu] → [Screen Layout].


In the [Standard] window, you can set parameters and waveforms displayed on the screen. For detailed
settings of [Screen Layout], refer to the “Screen Setup” section.

8-4
Chapter 9 Alarm

When a patient under monitoring or therapy as abnormal vital signs, or when failure occurs in the monitor, the
system sounds audible and visual alarm to remind the user.
When there are multiple alarms and prompt messages, messages scroll in a cycle.

Warning
 Use of different configuration on different monitors in one area (e.g., ICU or OR) may affect
patient’s safety

9.1 Alarm Type

Alarms generated by the monitor are classified into physiological and technical alarms.
 Physiological alarm
A physiological alarm is generated when a certain physiological parameter of the patient is beyond the
high/low alarm limit or the patient has physiological disorder. Physiological alarm messages are displayed in
the physiological alarm area in the upper part of the screen.
 Technical alarm
A technical alarm is triggered when the monitor does not operate normally or the monitoring result is
unreasonable due to improper operation or system failure. A technical alarm message is displayed in the
technical alarm area in the upper part of the screen.
NOTE: In addition to physiological and technical alarms, the monitor also shows messages about system
status. Generally, these messages shown in the system message area are not related to vital signs of the patient.

9.2 Alarm Level

Physiological and technical alarms are classified into high, medium and low-level alarms by severity.

Physiological alarm Technical alarm

Serious machine failure or


mishandling may not be able to
The patient is in life-threatening
situation (i.e. asystole, ventricular detect the patient's critical state
High-level alarm fibrillation/ventricular or cause the treatment function
tachycardia). An emergency to fail, making it life-
treatment may be required. threatening, such as low
battery.

9-1
Alarm

Some machine malfunctions or


mishandling may not threaten

Abnormality is detected in the patient safety, but may also


Medium-level alarm patient’s vital signs; treatment affect normal monitoring of
measures are taken promptly. critical physiological
parameters and patient
treatment.

Some equipment failures or


Abnormality is detected in the mis-operation may result in
Low-level alarm patient’s vital signs; treatment certain malfunctions, but will
may be necessary. not endanger the patient’s
safety.
The levels of all technical alarms (except ECG and SpO2) and some physiological alarms have been set before
delivery of the monitor and cannot be changed by the user. The levels of some physiological alarms can be
modified.

9.3 Alarm Mode

When an alarm is generated, the monitor uses the following alarm modes to alert the user:
Alarm Lamp
Audible Alarm
Alarm Message
Flashing Parameter

9.3.1 Alarm Lamp

Alarm indicators at the upper left corner of the monitor indicate alarm levels with different light colors and
flashing frequencies.
Physiological Alarm:
High-level: Red (Left light), flashing.
Medium-level: Yellow (Left light), flashing.
Low-level: Yellow (Left light), consistently on.
Technical Alarm:
High-level: Red (Left light), flashing.
Medium-level: Yellow (Left light), flashing.
Low-level: Cyan (Right light), consistently on.

9-2
Alarm

9.3.2 Audible Alarm

The monitor indicates alarm levels with alarm sounds with different intervals.
High-level: beep-beep-beep--beep-beep----beep-beep-beep--beep-beep

Medium-level: beep-beep-beep
Low-level: beep

Warning
 Both the bedside monitor and the CMS (Center Monitoring System) are provided with audible
alarm function.
 When this monitor is connected to the CMS, you can use the same high and low alarm limits for
the monitor and CMS. If you enable alarm delay on this monitor, it will not display when CMS
indicates an alarm.
 When multiple alarms of different levels are generated simultaneously, the monitor will activate
the warning sound and light for the highest level alarm.
 Certain physiological alarms, such as asystole and respiratory arrest, are exclusive. The sound
and light expression of this type of alarm is the same as that of the high-level alarm, but the
alarm information is displayed in an exclusive manner, that is, when the general physiological
alarm and the exclusive physiological alarm occur simultaneously, only the text alarm
information of the exclusive physiological alarm is displayed.

9.3.3 Alarm Message

Alarm messages are shown in the physiological alarm area or technical alarm area on the screen.
Different background colors are used to indicate the alarm levels:
High-level: Red
Medium-level: Yellow
Low-level: Yellow (Physiological Alarm)/ Cyan (Technical Alarm)

Different marks are added in front of alarm messages to indicate the alarm levels:
High-level: ***
Medium-level: **
Low-level: *

9.3.4 Alarm Parameter Flashing

When a parameter value is outside the alarm limit, the parameter and its high/low limits flash every second,
indicating the measured result is beyond the high or low limit.

9-3
Alarm

9.4 Set Alarm Volume

9.4.1 Set Minimum Alarm Volume

Do not set the minimum alarm volume too low; otherwise you cannot hear the alarm sound. This may put the
patient safety into danger. Follow the steps below to set the minimum alarm volume:
1) Enter [User Maintain] → [Alarm Setup] → [Min. Alm Volume].

2) Set the appropriate value.

Note
 When the alarm volume is turned down, the alarm sound may be hard to be heard. Set the
minimum alarm volume should be higher than environmental noise.
 The pressure level of alarm sound generated by this monitor is 45-85db.

9.4.2 Set Alarm Volume

1) Enter [Main Menu] → [Volume Setup].

2) Select [Alm Vol] in the pop-up menu.

3) Select the volume within the range of X~10. X represents the lowest volume, which depends on the

setting of minimum alarm volume.

When the alarm volume is set to 0, the icon is shown in the message prompt area of the screen, indicating

the sound is off.


4) Enter the [User Maintain]→ [Alarm Setup]. You can also set the alarm volume of high-level and

medium-level alarm respectively by entering the value in[High Alarm] and [Medium Alarm]based on the

setting in[Alm Vol].

Warning
 When the alarm volume is set to 0, the monitor cannot sound an alarm even if a new alarm is
generated. Therefore, you should consider this when setting the alarm volume to0.
 Do not rely only the audible alarm. Otherwise, patient safety may be at risk if the alarm
volume is low. Pay close attention to the patient’s actual clinical conditions.
 Maximum alarm volume is no more than 10.

9-4
Alarm

9.4.3 Set Alarm Reminder

When the alarm volume is set to 0, the monitor provides periodic prompt tone to remind that there is an
activated alarm in the system. Follow the steps below to set alarm reminders.
1) Enter [User Maintain] → [Alarm Setup].

2) Switch [Alarm Reminder] to [ON] or [OFF].

3) Select [Reminder Interval]: [1 Min], [2 Min] or [3 Min].


Select [Reminder Volume]: set it to a value between 1 (the minimum volume) ~10 (the maximum volume).

9.5 Set Parameter Alarm

Warning
 When setting alarm limits to extreme values, the alarm system may be useless.
 When setting high and low alarm limits, make sure the patient type is correct (ADU, PED or
NEO).
 If you have set the high and low alarm limits manually, the monitor will display these high and
low alarm limits instead of the default alarm limits of the system.
 If power-off accidentally occurs, the equipment retain the latest setting for 120s.After120s, the
monitor sets the configurations according to [Startup Configuration] when restarts.

Note
 When applying factory default configurations, alarm limits of the parameters will also change.
See “Default Configurations” for details.

9.5.1 Set Alarm Limit

Colors of Alarm Limits


 Red represents high-level alarms

 Yellow represents medium-level alarms

 Cyan represents low-level alarms


Intelligent alarm gradation is a characteristic of the alarm system. For parameters of intelligent alarm
gradation, you can simultaneously set the alarm limit ranges of high, medium and low-level alarms without
setting alarm levels. When the measured parameter value is outside the normal range, the monitor
automatically recognizes which alarm range the measured parameter value belongs to, and then will generate
an alarm of the corresponding level.

9-5
Alarm

For parameters of general alarms, you need to set the alarm level and only set the alarm limits corresponding
to the alarm level selected. When the measured parameter value is beyond the normal range, the monitor will
generate an alarm according to the alarm level selected. Intelligent alarm gradation is available on ECG, NIBP,
PR, AwRR and SpO2 (excluding Nellcor SpO2) and not other parameter.
For parameters subject to intelligent alarm gradation, the procedures to set alarm limit are the same. For
example:
1) Select the ECG parameter area to enter the setup menu → [Alarm Limit Setup].

2) Set the appropriate high and low limits for the parameter.

3) Switch the alarm ON/OFF icon to [ON].

4) When setting is finished, select the confirm key .

For parameters subject to general alarms, the procedures to set alarm limit are the same. For example:
1) Select the RESP parameter area to enter the setup menu → [Alarm Limit Setup].

2) Select the check box at the lower left corner of the setup window of the corresponding parameter to
toggle the alarm level.

3) Set the appropriate high and low limits for the parameter under the current level.

4) Switch the alarm ON/OFF icon to [ON].

5) When setting is finished, select the confirm key .

9.5.2 Set Auto Alarm Limit

The monitor can automatically set the Alarm Limits for the currently measured parameters according to the
patient type.
Before applying these alarm limits, make sure they are appropriate for the patient. If inappropriate, you need
to manually set the alarm limits.
Follow the steps to set auto alarm limit:
Enter [User Maintain] → [Alarm Setup] → [Auto Alarm Limit].

9.6 Set Alarm Delay

The system provides five options for parameter alarm delay: [Not Allowed], [5s], [10s], [15s] and [20s]. If
[Not Allowed] is selected, when the measured parameter is beyond the alarm limit, the monitor gives alarm
immediately. If [5s]/[10s]/[15s]/[20s] alarm delay is selected, the monitor gives alarm when the measured
parameter value has been consistently beyond the alarm limit for 5s, 10s, 15s, 20s, respectively.
NOTE: Alarm delay cannot be applied to ECG and IBP.
Follow the steps to set alarm delay time:

9-6
Alarm

1) Enter [User Maintain] → [Alarm Setup] → [Alarm Delay].

2) Set the appropriate delay time.

9.7 Set Alarm Recording

If the monitor is equipped with a recorder, the monitor recorder will print the parameter waveform and value,
if all the following conditions are satisfied: a parameter value is abnormal, the alarm switch is turned on, and
[Alm Record] is set to on.
1) Enter [Main Menu] → [Alarm Setup] → [Alarm Record Setup].

2) Set [Alm Rec Time] to [8s].

3) To activate alarm recording for a parameter, switch the alarm record icon to [ON]; to activate
alarm recording for all parameters, select [All Rec. On].
You can switch the alarm record icon to [OFF] to deactivate alarm record of one specific parameter; to
deactivate all parameter alarm records, select [All Rec. Off].

9.8 Alarm Pause

To quickly enter the alarm pause status, press the key on the control panel. When alarm is paused, the
followings occur:
 Alarm sound, alarm light and alarm message are disabled for physiological alarms, and no physiological

alarms will be triggered.

 The physiological alarm message area shows the prompt message ―Alm Pause XXXs‖.

 Alarm sound and alarm light are disabled for technical alarms; if a new technical alarm is triggered, only

text prompt will be given.

 In the event of the battery too low alarm, this alarm will exit the alarm pause status and automatically

resume the sound, light and message.

 The key on the front panel turns red.

 There will be icon displayed in the icons area.

After the alarm pause time expires, the monitor cancels alarm pause automatically; you can press the key
to cancel alarm pause.
To set alarm pause time, follow:
1) Enter [User Maintain] → [Alarm Setup] → [Alm Pause Time].

2) Set the appropriate pause time: [1min], [2min], [3min], [5min], [10min], [15min].

9-7
Alarm

9.9 Alarm OFF

Only physiological alarms can be turned off. When alarm is turned off, the sign is shown on the left side
below the corresponding parameter in the parameter area:
 For physiological alarms, sound, light and text prompts are disabled, and no new physiological alarms

will be triggered.

 No measured parameter value and alarm limit flash


Follow the steps to turn alarm off:
1) Select the parameter value area, and the setup menu displays. Then select [Alarm Limit Setup].

2) Select [All Alm Off] to disable alarms against all parameters. If the alarm ON/OFF icon of a
parameter is switched to [OFF], alarms for that parameter are disabled.
To turn on the alarms of all parameters, select [All Alm On]; to turn on the alarm of one parameter, switch the
alarm ON/OFF icon of that parameter to [ON].

Warning
 If the alarm is turned off, the monitor cannot provide alarm indications when the parameter is
in an alarm condition. Therefore, you should be careful turning the alarm off.

9.10 Alarm System Off

The alarm system is disabled by default when entering the manual defibrillation mode or AED mode. The
monitor provides periodic prompt tone to remind that the alarm system is disabled.
After entering the synchronous defibrillation mode, monitoring mode or pacing mode, the alarm system is
automatically turned off.

9.11 Alarm Reset

You can reset the current alarm with the [Alarm Reset] soft key:
 Cease the audio alarm indication of all physiological alarms and technical alarms.

 If a new alarm occurs, resetting will be interrupted, and the alarm indications are generated immediately.

 For the technical alarms of leadoff and sensor off, background color is cleared and alarm light is

switched off. Other physiological and technical alarms background color and alarm light cannot be

cleared.
The sign√ appears in front of the alarm message, indicating that the alarm is acknowledged.

9-8
Alarm

9.12 Alarm System Test

After the monitor is turned on, the alarm indicator will light up in cyan and red, cyan and yellow, and the light
alarm signal will start working. If the alarm system does not work properly, please contact our engineers in
time.
The system can be further tested through SpO2 or NIBP parameter. For example:
1) Connect the SpO2 cable to the monitor.

2) Set the SpO2 alarm limits to 90% and 60%, respectively.

3) Set [Alm Vol] to any level among 0~10.

4) When the measured value is beyond the high/low alarm limit, confirm whether the changes in sound,

light , message and parameter flashing on the monitor conform to the descriptions in the section “Alarm

Lamp”, “Audible Alarm”, “Alarm Message”, and “Alarm Parameter Flashing” in this chapter.

Meanwhile, the physiological alarm message area shows [SpO2 Too High] or [SpO2 Too Low].

5) Pull out the SpO2 sensor from the monitor; the technical alarm message area shows [SpO2Finger Off].

9-9
Chapter 10 PR Setup

10.1 Overview

Mechanical activity of the heart causes artery pulse. PR value can be obtained by measuring the pulse. Color
of the PR parameter area is consistent with the color in which the parameter of PR source is shown.

10.2 PR Source

Select the PR parameter area to enter the setup menu, where you can set PR Source.
[SpO2]: Display the pulse rate value from SpO2;
[NIBP]: Display the pulse rate value from NIBP;
[ART], [PA], [UAP], [BAP], [FAP], [P1], [P2], [P3], [P4], [LV], [AO]: Specific pressure parameters from
IBP; display the pulse rate value from IBP (The pressure parameter selected as the source depends on which
pressure parameter is monitored by the monitor).

10.3 Alarm Limit Setup

Select the PR parameter area to enter the setup menu, where you can carry out alarm limit setup.

10-1
Chapter 11 ECG Monitoring

11.1 Definition of ECG Monitoring

Electrocardiography (ECG) monitors continuous electrical activity of the patient’s heart, which is reflected on
the monitor in the form of wave and value, to accurately assess the current physiological status of the patient.
Therefore, you must make sure the ECG cables are connected properly to obtain correct measurement values.
The monitor is suitable for three-lead, five-lead or twelve-lead monitoring. It can also be used for ECG
monitoring using external defibrillation electrode paddles and multi-functional electrode pads. Different
waveforms are displayed according to ECG cables of different leads.

11.2 Precautions for ECG Monitoring

Warning
 During defibrillation, do not contact the patient, table or equipment.
 Before monitoring, ensure that ECG cable is properly connected. If the ECG cable is
disconnected from the connector, the monitor displays the prompt message “ECG Lead Off”
and sounds an alarm.
 Use only ECG electrodes and cables specified by Comen.
 The ECG cable with defibrillation-proof protection should be used when conducting
defibrillation.
 Different metal materials cannot be used for the electrodes.
 Do not use if the electrode package or electrode has signs of damage.
 Please do not mix electrodes of different types and brands. Mixing the electrodes may result in
a large baseline drift or a longer recovery time after defibrillation.

 When connecting the electrodes or patient cable, ensure that the patient does not come into
contact with any other conductive parts or the ground. Confirm that all ECG electrodes
(including neutral electrode) are attached the patient’s body.
 Check whether the ECG electrode patch or paddle has irritation to the skin every day. If there
is any sign of allergy, replace the electrode or paddle or change its position.
 Pacemaker fault: When cardiac conduction is completely blocked, or the pacemaker cannot be
moved away, P wave (> 1/5 of the mean height of R wave) may be wrongly recorded by the
monitor, causing failure to monitor an asystole.
 Equipment such as defibrillator and remote measurement unit can generate a filtered ECG
signal. When this signal is used as the input signal for bedside monitor, it is filtered again. If

11-1
ECG Monitoring

such signal after second filtering is transmitted to the arrhythmia algorithm, it may cause
failure to detect such conditions as pacemaker pulse, pacemaker capture failure or asystole.
This failure degrades the performance of the equipment when it is used for monitoring patients
with pacemakers.
 During defibrillation, the ECG cable connected to the patient may get damaged. When reusing
such cables, you should check that function properly.
 If electrodes are used correctly and attached according to the manufacturer’s instructions, the
ECG parameter on monitor screen recovers within 5safter defibrillation. For electro surgery or
defibrillation, the measurement accuracy may be reduced temporarily, but this accuracy will
not affect the safety of the patient or the equipment.
 When the monitor is connected to an electrosurgical unit (ESU), in order to protect the patient
from injury caused by leakage current, do not put the sensors and cables of the equipment in
contact with the ESU.
 Do not expose the monitor to X-ray and high-intensity magnetic fields.

Note
 Interference from ungrounded equipment near the patient, as well as ESU interference may
result in a waveform problem. If the monitor is operated under conditions specified in
EN60601-1-2 (radiation resistance: 3V/m), electric field intensity over 1V/m may cause
measurement errors at different frequencies. Therefore, it is suggested not to use any electric
radiation equipment in a place near the monitor if ECG/RESP is being measured.
 If the ECG electrode is correctly placed but the ECG waveform is still inaccurate, replace the
leads.
 To protect the environment, recycle and dispose used electrode patches appropriately.
 Dot not to use external paddles to conduct ECG monitoring.
 If the source of the selected ECG signal is not available, the ECG waveform will be shown as a
dotted line.

11.3 ECG Display

3 4 5 6 7 8 9

11-2
ECG Monitoring

Attention

 The pacing signal detected will be shown as “ ”in the ECG waveform.
1. ECG waveform
2. ECG lead name
Select the lead name and rotate the knob to switch ECG lead name.
3. ECG wave gain
Select the gain and rotate the knob to switch ECG wave gain.
4. Filter mode
Select the filter mode and rotate the knob to switch the filter mode.
5. Notch status
6. 1 mV Scale
7. ECG alarm limit
8. ECG value
9. PVCs and ST-I analysis
Display the current analysis state of PVCs and ST segment with the refresh rate of once per second.

11.4 Monitoring Steps

11.4.1 Prepare Skin

Skin is a poor conductor. Therefore, to achieve good contact between electrodes and skin, it is very important
to prepare the patient’s skin:
1) Choose a skin area without any damage or abnormality.

2) When necessary, shave body hair at positions where electrodes will be placed.

3) Use soap water to thoroughly clean the skin. (Do not use diethyl ether or pure alcohol because these

substances may increase the skin impedance).

4) Air-dry the skin completely.

5) Use ECG preparation paper and gently rub the skin, so as to remove dead skin and improve the

conductivity at the position where the electrode is attached.

11.4.2 Install ECG Leads

The table below lists the names of leads in European and American standards. (RA, LA, RL, LL and V are
used to represent leads in American standards, whereas R, L, N, F and C are used in European standards):

11-3
ECG Monitoring

See table below for marks and color codes of 3-lead and 5-lead electrodes:
U.S.A. Standard EU Standard

Mark Color Mark Color

RA White R Red

LA Black L Brown

LL Red F Green

RL Green N Black

V Brown C White

See the table below for marks and color codes of 12-lead electrodes:
U.S.A. Standard EU Standard

Mark Color Mark Color

RA White R Red

LA Black L Brown

RL Green N or RF Black

LL Red F Green

V1 Red C1 Red

V2 Brown C2 Brown

V3 Green C3 Green

V4 Blue C4 Brown

V5 Orange C5 Black

V6 Purple C6 Purple

11.4.2.1 Place 3-lead Electrodes

Refer to American and European standards for placing electrodes of 3-lead unit:
White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Red/green (left leg) electrode — Place it at the left lower abdomen

11-4
ECG Monitoring

Lewis
LA Black (U.S.A.)
L Yellow (EU)
RA White (U.S.A.)
R Red (EU)

LL Red (U.S.A.)
F Green (EU)

11.4.2.2 Place 5-lead Monitoring Electrodes

Refer to American and European standards for placing electrodes of 5-lead unit:
White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Green/black (right leg) electrode — Place it at the right lower abdomen
Red/green (left leg) electrode — Place it at the left lower abdomen
Brown/white (chest) electrode — Place it on the chest wall according to the following figure.

Lewis LA Black (U.S.A.)


L Yellow (EU)
RA White (U.S.A.)
R Red (EU)

V Brown (U.S.A.)
C White (EU)

RL Green (U.S.A.) LL Red (U.S.A.)


N Black (EU) F Green (EU)

For 5-lead configuration, place the chest (V) lead electrode at one of the following positions:
V1: 4th intercostal space, at the right sternal border.
V2: 4th intercostal space at the left sternal border.
V3: In the middle position between V2 and V4.
V4: 5th intercostal space at the left midclavicular line.

11-5
ECG Monitoring

V5: In the left anterior axillary line, just parallel to V4.


V6: In the left midaxillary line, just parallel to V4.
V3R-V6R: On the right side of the chest wall, corresponding to the left-side position.
VE: At the xiphoid eminence position.
V7: 5th intercostal space in the left posterior axillary line at the back.
V7R: 5th intercostal space in the right posterior axillary line at the
back.

11.4.2.3 Place 12-lead Monitoring Electrodes

White/red (right arm) electrode — Place it below the clavicle, near the right arm.
Black/yellow (left arm) electrode — Place it below the clavicle, near the left arm.
Green/black (right leg) electrode — Place it at the right lower abdomen
Red/green (left leg) electrode — Place it at the left lower abdomen

Lewis
LA Black (U.S.A.)
L Yellow (EU)
RA White (U.S.A.)
R Red (EU)

RL Green (U.S.A.) LL Red (U.S.A.)


N Black (EU) F Green (EU)

There are generally six electrode positions on the chest, using intercostal gap to pinpoint the positions, V1 ~
V6:
V1: 4th intercostal space, at the right sternal border.
V2: 4th intercostal space at the left sternal border.
V3: In the middle position between C2 and C4.

11-6
ECG Monitoring

V4/C4: 5th intercostal space at the left midclavicularline


V5/C5: on the left anterior axillary line, horizontal with the C4 electrode position
V6/C6: on the left midaxillary line horizontal with the V4 electrode position

11.4.2.4 Recommended ECG Lead Connection for Surgical Patient

Warning
 When using an ESU, never place electrodes close to the ground plate of the ESU; otherwise
there is too much interference against the ECG signal.
 When the monitor is connected to an electrosurgical unit (ESU), in order to protect the patient
from injury caused by leakage current, do not put the sensors and cables of the equipment in
contact with the ESU.

The placement of ECG lead depends on the type of operation to be performed. For example, when a
thoracotomy is to be performed, the electrode can be placed on the side of the chest or on the back. In the OR,
artifacts may affect ECG waveform due to the use of an ESU. In order to reduce artifacts, the electrodes can
be placed at the left and right shoulders, close to the left and right sides of the abdomen; the chest lead can be
placed left to the middle of the chest. Avoid placing the electrode on the upper arm, or the ECG waveform
may become very small.

Note
 When monitoring the patient with pacemaker, [Pace] must be set to [On]. If it is set to [Off],
pacemaker pulses may be counted as QRS complex, resulting in failure to detect asystole.
When changing patient info or admitting/discharging a patient, check whether [Pace] is set
correctly.
 When monitoring the patient with pacemaker, sometimes a part of pacemaker pulses cannot
be shielded. If pacemaker pulses are counted as QRS complex, it results in wrong heart rate
computation and failure to detect asystole or some arrhythmias. At this point, closely observe
the patient.

11-7
ECG Monitoring

11.4.3 Placement of Pads or External Paddles

11.4.3.1 Preparation

1) Do skin preparation. Refer to Section 11.4.1 Prepare Skin.


2) Place external paddles or pads
 For pads: place pads on patient in the anterior-lateral position according to the indication on the
packaging.
 For external paddles: hold the handle of paddles with two hands and take the paddles out form the
paddle tray. Apply some conductive gel to the paddles and place them on patient in the anterior-
lateral position.
3) For pads: connect pads with pads cable.
4) Connect paddles cable or pads cable to the Defibrillator Monitor until the ―click‖ is heard.

11.4.3.2 Anterior-Lateral Placement

1. Place the RA pad or Sternum paddle on the patient’s upper right torso, lateral to the sternum and below
the clavicle, as shown below:
2. Place either the LL pad or Apex paddle lateral to the patient’s left nipple in the midaxillary line, with the
center of the electrode in the midaxillary line, as shown below:

Sternum
paddle

Apex paddle

Attention
 When conducting ECG monitoring, the external paddles and pads can only be placed in the
anterior-lateral position.

11-8
ECG Monitoring

11.5 ECG Setup

11.5.1 Checking the Pacing Status

It is important to properly set the patient's pacing status before starting ECG monitoring. When [Pace] is set to

"On" and the pacing signal is detected, it is indicated by on the ECG waveform and symbol in the

patient information area; when the pacemaker is set to "Off", is only prompted in the patient information

area and the pacing pulse is filtered out.


You can change the pacing status in any of the following ways:
 Select the interface patient information area to enter the [Patient Info] menu and set [Pace] to On or Off.
Or;
 Select [Main Menu] → [Patient Info] and set [Pace] to On or Off in the pop-up menu.
Or;
 Select the ECG parameter area to enter the ECG setting menu, then select [Other Setup] and set [Pace] to
On or Off.

Warning
 For the patient without pacemaker, [Pace] must be set to [OFF]. Otherwise, the system cannot
detect arrhythmia related to ventricular premature beats (including PVCs count), and ST
segment analysis will not be carried out.
 If the patient is admitted with a pacemaker, [Pace] should be set to [ON]. Otherwise,
pacemaker pulse may be counted as normal QRS wave, resulting in failure to detect the [ECG
Lost] alarm.

11.5.2 Set Lead Type

ECG cables with different leads can be used to monitor different ECG waveforms. You can use the 3-lead, 5-
lead and 12-Lead ECG cables with the monitor.
When the 3-lead ECG cable is used, leads for monitoring include I, II and III. In the standard screen, ECG
wave of at most 1 lead is displayed.
When the 5-lead ECG cable is used, leads for monitoring include I, II, III, aVR, aVL, aVF and V. In the
standard screen, ECG wave of at most 2 leads are displayed.
When the 12-lead ECG cable is used, leads for monitoring include I, II, III, aVR, aVL, aVF,V1, V2, V3, V4,
V5, and V6. In the standard screen, ECG wave of at most 2 leads are displayed.

11-9
ECG Monitoring

When the lead type of the monitor is set to [Auto], the monitor automatically recognizes the leads for
monitoring.
Set the lead type for the ECG cable of the monitor:
1) Select the ECG parameter area to enter the setup menu → [Lead Type] → [3 Leads], [5 Leads], [12

Leads] or [Auto].

11.5.3 Smart Lead Off

When [Smart Lead Off] is ON, if the lead of the current channel comes off, the monitor automatically
switches to a channel where the lead is not off. When the lead that comes off is reconnected, the monitor
automatically switches back to the original channel.
Enable or disable this function:
1) Select the ECG parameter area to enter the setup menu → [Other Setup].

2) Select [Smart Lead Off], and switch it to [ON] or [OFF].

11.5.4 Set Alarm Level for Lead Off

Enter [User Maintain] → [Alarm Setup] → [ECG Lead Off Level].

11.5.5 Set Lead Name for Monitoring

In the standard screen, when 3 Leads is selected as the lead type, only one ECG wave is displayed; when 5
Leads or 12 Leads is selected, two ECG waves are displayed.
1) Select the ECG wave to enter the [ECG Wave] menu → [Lead Name]

2) Select the lead for monitoring, such lead as [II].

11.5.6 Set Wave Gain

If the wave size is too big or too small, you can change the displaying size of wave by setting the gain. The
gain setting will not affect ECG signal analysis of the monitor. With the wave and the 1mv scale provided on
the right side of the wave, you can obtain the optimal wave.
1) Select one ECG wave to enter the [ECG Wave] menu → [Gain].

Note
 When the input signal is too strong, the wave crest may be cut off. In such case the user can
manually change the gain level of ECG wave according to the actual wave to avoid incomplete
wave display.

11-10
ECG Monitoring

11.5.7 Set Filter Mode

Filter Mode: Clearer or more accurate waves can be obtained through filtering. Four filter modes are available.
 In the Diagnosis mode, ECG waves displayed are those without filtering.

 In the monitor mode, the monitor filters artifacts that may result in false alarms.

 In the Surgery mode that usually used in the OR, the monitor reduces artifacts and interference from the

ESU.

 In the ST filter mode, the distorted reflection of the ECG signal ST segment of the patient being

measured can be guaranteed, and high-frequency interference signal above 40Hz, including power

frequency interference, can be filtered effectively. In this mode, user obtains the value of ST segment of

the patient being measured by adjusting the position of ST segment analysis point.

 The filter mode acts on two channels simultaneously, and can be displayed above the first ECG wave.

1) Select one ECG wave to enter the [ECG Wave] menu → [Filter Mode] → [Dia.], [Monitor], [Therapy] or

[ST].

Warning
 The system provides raw signals only in the diagnosis mode. In the [Monitor] and [Therapy]
filter modes, the ECG wave distorts to different degrees. In this case, the system only provides
the basic ECG information, which greatly affects the result of ST segment analysis.

11.5.8 Set Computation Lead

You are allowed to select the leads for HR computation and arrhythmia analysis. When setting the lead, make
sure that the following wave characteristics in this lead are satisfied:
a) Tall and narrow without notch.

b) R wave is tall, completely above or below the baseline.

c) T wave is less than 1/3 height of R wave.


P wave should be much smaller than T wave.

11-11
ECG Monitoring

The computation channels are different under different lead types:


The 3 Leads: Lead II, and no other options are provided.
The 5 Leads: Three options are provided: lead I, II and V.
The 12 Leads: Eight options are provided: lead I, II, V1, V2, V3, V4, V5 and V6.
Select a Lead:
1) Select the ECG parameter area to enter the setup menu → [Calculate Lead]; set the lead for calculation

and arrhythmia analysis.


To obtain 1mV calibrated ECG wave, perform an ECG calibration. For the ECG calibration method, refer to
the “Maintenance” chapter.

11.5.9 Set Notch Filter

The notch filter removes the line frequency interference. When the filter is not set to diagnosis mode, the
system turns on [Notch Filter] automatically. When the filter is set to diagnosis mode, [Notch Filter] can be
turned on or off as needed.
1) Select the ECG parameter area to enter the setup menu → [Other Setup]

2) Set [Notch Filter] as follows:


[Strength g]: Select it when the wave jitters frequently (e.g., the wave has burrs).
[Weak]: Select it when the wave jitters in a few times.
[Off]: Notching will not be performed.
Set notch frequency according to the electric power frequency of your country.
1) Enter [User Maintain] → [Other Setup] → [Notch Filter].

2) Select [50Hz] or [60Hz] according to the power supply frequency.

Attention
 The setting of Notch Filter is not affected by the operation of restoring manufacturer
configuration or switching machine.

11-12
ECG Monitoring

11.5.10 Set Pacer Rejection

Select the ECG parameter area to enter the setup menu → [Other Setup]. In the pop-up setup menu, select
[Pacer Reject] and switch it to [ON] or [OFF].

When [Pace] is turned on:


 In the condition of [Pacer Reject] being on, the display of pacing signal is inhibited. However, when

pacing signal is detected, the pacemaker pulse symbol is still displayed in the ECG wave.
 In the condition of [Pacer Reject] being off, the display of pacing signal is not inhibited. When pacing

signal is detected, the pacemaker pulse symbol is displayed above the ECG wave.
When [Pace] is turned off, [Pacer Reject] cannot be operated.

11.5.11 HR Source

You can set the HR source to determine whether HR value or PR value is displayed in the ECG parameter
area. The HR value color is consistent with the source parameter selected. Select the ECG parameter area to
enter [ECG Setup], and set [HR Source] as follows:
 [ECG]: The ECG parameter area displays the HR value, and the heartbeat sound is provided.
 [SpO2]: The ECG parameter area displays the pulse rate value from SpO2, and the pulse sound is
provided.
 [ART], [PA], [UAP], [BAP], [FAP], [P1], [P2], [P3], [P4], [LV], [AO]: Specific pressure parameters
from IBP as the source; display the pulse rate value from IBP (The pressure parameter selected as the
source depends on which pressure parameter is monitored by the monitor).

11.5.12 Multiple Lead Analysis

When [Mul. Lead Analysis] is turned on, the ECG setting of [Calculate Lead] become invalid. The module
intelligently selects the lead with good ECG wave for HR computation calculation.
1) Select the ECG parameter area to enter the setup menu→[Other Setup].

2) Select [Multi. Lead Analyse], and switch it to [ON] or [OFF].

11.5.13 Cascade

Cascade is for user to observe the designated real-time ECG waveform for a long period of time. The Cascade
screen shows a cascade waveform of the same lead. In any working mode of the monitor, you can select ECG
waveform and turn on [Cascade]in the pop-up[ECG Wave]. The number of cascade waveforms displayed

11-13
ECG Monitoring

depends on the number of ECG waves present in the current screen. The operation over one of the ECG waves
also applies to other ECG waves.

Note
 In the screen of [12-Lead ECG], [cascade] is not selectable.

11.6 ST Segment Analysis

11.6.1 About ST Segment Analysis

Normal heartbeat and atrial pacing heartbeat are used in ST segment analysis. The monitor analyzes these
heartbeats and calculates the elevation and depression of ST segment. On the monitor, the calculated data can
be displayed as the ST value. All available leads can be monitored continuously. For ST segment analysis, it
is unnecessary to display ECG waveform on the monitor. During ST segment analysis, a special filter should
be used to ensure the diagnosis quality. If you use an ECG filter mode other than [ST] to monitor ECG, the ST
segment of ECG wave may be slightly different in appearance from the ST segment of ST fragment for the
same waveform. To perform diagnostic assessment of ST segment, always switch to the [ST] filter mode.
In the ST segment analysis, the elevation or depression of ST segment on the designated lead can be measured.
Meaning of ST segment value: A positive number represents elevation; a negative number represents
depression.
ST segment measurement range: -2.0 ~ +2.0mV.

11.6.2 Influence Factors on ST Segment

Some clinical situations may result in unreliable ST monitoring. For example:


 Lead of low noise cannot be obtained.

 Presence of arrhythmia (e.g., atrial fibrillation/atrial flutter) that can cause irregular baseline.

 The patient is under continuous ventricular pacing.

 The patient has left bundle branch block.


Under these circumstances, you should consider turning off ST monitoring.

Warning
 This monitor provides information about changes in ST level, the clinical significance of should
be determined by a doctor.

11.6.3 ST Analysis On/Off

1) Select the ECG parameter area to enter the Setup menu → [ST Analysis].

11-14
ECG Monitoring

2) Select [ST Analysis], and switch it to [ON] or [OFF].

11.6.4 Adjust ST Point

Set the R wave peak point as the reference point for ST measurement point. The ST value for each beat
complex is the vertical difference between ISO point and ST measurement point. See the figure below:

R wave

J Difference= ST value

ISO point
ST measurement point

Note
 If the HR value or ECG wave of the patient has changed obviously, you should adjust the
position of ISO and ST points. Abnormal QRS complex is not considered for ST segment
analysis.
 Ensure that the position of ST measuring point is suitable for the patient.

Method for adjusting ISO and ST points:


1) Select the ECG parameter area to enter the setup menu → [ST Analysis].

2) Set [ST Analysis] to [ON].

3) Select [Adjust ST Point] to enter the [ST Analysis] window: three vertical lines are ISO, Jand ST,

respectively.

4) Select [ST Lead] to switch the measurement lead. Each time the shuttle is pressed, the name of the ST in

the window changes once, and an obvious ECG lead of the J point and the P wave is selected.

5) Select the points of [ISO (ms)] and [ST (ms)], press the button to adjust, and [J] to confirm the position

of each point.

 The cursor position of ISO point is related to R wave peak equipotential. Use to locate the

ISO point in the middle of the flattest part of baseline (between P and Q waves or in front of P

wave).

 The cursor position of J point decides the relative position of J point and R wave peak. This can help

user to correctly locate the ST point. Use to place J point at the end of QRS complex and the

beginning of ST segment.

 Locate ST point: Select J+60, J+80 or J+40 to convert the value and move J point to locate ST point

11-15
ECG Monitoring

in the middle of ST segment.


6) When setting is finished, select ― ‖ to exit the window.

11.6.5 ST Analysis Review

This monitor saves 20 groups of ST analysis for reference and review. A ST segment shows a complete QRS
wave of all ST leads. The stored data is drawn in white; real-time data is drawn in green. Real-time data of ST
segment refreshes every 5s.
Enter [ST Analysis Review]:

1) Select the ECG parameter area to enter the setup menu → [ST Analysis]; open [ST Analysis] → [ST

Analysis Review].

 To save the current ST segment as reference, select [Save Ref.] (Save Reference).

 To delete the current reference segment displayed, select [Del Ref] (Delete Reference).

 To view several groups of ST segments, select to turn page up and down.

11.6.6 ST Alarm

Select the ECG parameter area to enter the setup menu → [ST Analysis].Open [ST Analysis] → [Alarm Limit
Setup] to set parameter alarm limit. The monitor allows you to set alarm limits for each lead. For operation
details, refer to the “Alarm” chapter.

11-16
ECG Monitoring

11.7 Arrhythmia Analysis

Arrhythmia analysis is clinically used in patient ECG monitoring to detect HR changes and premature
ventricular contractions, and to save arrhythmia events and generate alarm messages. Arrhythmia analysis can
be used for monitoring patients implanted or not implanted with pacemakers. The doctor can evaluate the
patient’s condition (e.g., HR, PVCs (premature ventricular contractions) frequency, rhythm and abnormal
heartbeat) according to arrhythmia analysis, and make diagnosis and treatment on this basis.
The arrhythmia monitoring is set off by default. You can enable this function as needed.
The arrhythmia monitoring can measure and classify arrhythmia and abnormal heartbeat, as well as reminding,
the doctor to observe the patient’s heart rhythm and events that generate alarms.

11.7.1 Arrhythmia Analysis On/Off

1) Select the ECG parameter area to enter the Setup menu → [Arr Analysis].

2) Select [Arr Analysis], and switch it to [ON] or [OFF].

11.7.2 Arrhythmia Alarm Setup

1) Select the ECG parameter area to enter the setup menu → [Arr Analysis].

2) Turn on [Arr Analysis].

3) Select [Arr Alarm Setup] to enter the [Arr Alarm Setup] window. In the [Arr Alarm Setup] window, you

can restore the settings, switch alarm on/off, set alarm level and switch record on/off or the alarms of

[Asystole], [Vfib], [R ON T], [VT>2], [Couplet], [PVC], [Bigeminy], [Trigeminy], [SVT], [Brady]

(Bradycardia), [Pacer Not Capture], [Pacer Not Pacing], [Missed Beat], [IHB] (Irregular Heart Beat),

[Vtac] (Ventricular Tachycardia), [Tachy] (Tachycardia), [PVCs Too High], [Extreme Tachy], [Extreme

Brady], [Vent. Rhythm], [Heart Pause], [Vent. Brady], [Multif. PVCs Window], [Nonsus. Vtac], [Afib]

and [Pause/min]. Select [Restore] to restore equipment to factory settings for the monitor.
NOTE: The alarm level and alarm on/off status of [Asystole], [Vfib], [Vtac], [Extreme Tachy], [Extreme
Brady] and [Vent. Brady] are in default, which cannot be changed by the user.
 When using multi-functional electrode pads and electrode paddles for ECG monitoring, only five

arrhythmia alarms, Asystole, Vfib, Vtac, PNP, and PNC, are provided, and only Asys. Delay and

Vtac Rate threshold settings are provided.

11-17
ECG Monitoring

Attention
 Asystole, Vfib, Vtac, Vent. Brady, Extreme Tachy, and Extreme Brady are exclusive high-level
alarms. For Asystole alarms, regardless of whether the arrhythmia analysis is turned on, an
alarm is triggered as long as the alarm condition is met.

11.7.3 Arrhythmia Threshold Setup

You can set the threshold of each arrhythmia by selecting [ECG] in the parameter area, and then in the pop-up
[ECG Setup] menu, enter the [ARR Analysis] menu. The parameter ranges are shown as below:
No. Arrhythmia Type Setup Range Default Value Step Unit
1 PVCs 0-31 10 1 PCS
2 Tachycardia ADU: 60-160 ADU: 120 1 bpm
PED:60-180 NEO/PED: 160
NEO:60-200
3 Extreme ADU: 120-300 ADU: 160 1 bpm
Tachycardia PED:160-300 PED: 180
NEO:160-350 NEO: 200
4 Extreme 15-40 40 1 bpm
Bradycardia
5 Arrest Time 3-10 4 1 s
6 Ventricular 100-180 160 1 bpm
Tachycardia HR
7 Ventricular 3-15 12 1 PCS
Tachycardia PVC
8 Bradycardia HR 40-120 40 1 bpm
9 Vbrd PVCs 3-99 4 1 PCS
10 Multi. PVC 3-31 15 1 PCS
11 Heart Pause Time 1.5-3.5 2.5 0.5 s
12 Pause/min 1 -15 8 1 min
After setting Arrhythmia Threshold, when a value exceeds this threshold, an alarm will be triggered.

Attention
 The setting of Asys. Delay is associated with ECG self-learning. When the HR is less than
30bpm, it is recommended to set the Asys. Delay to 10 seconds.

11.7.4 Arrhythmia Review

See the “Alarm Event Review” chapter.

11-18
ECG Monitoring

11.7.5 ARR Relearn

During ECG monitoring, when the ECG template of the patient changes significantly, you may need to start
an ARR Relearn. ARR Relearn enables the monitor to learn new ECG templates, thus to correct arrhythmia
alarms and heart rhythm values.
1) Select the ECG parameter area to enter the Setup menu → [ARR Analysis].

2) Select [ARR Relearn]; the system will give the prompt message [ARR Learning].

11.8 ECG Relearn

During ECG monitoring, if the patient’s ECG template changes significantly, you may need to manually start
an ECG Relearn. Changes in the ECG template may result in:
 Arrhythmia alarm error

 ST measurement data loss

 Inaccurate HR value
Start relearning:
Select the ECG parameter area to enter the setup menu → [Other Setup] → [Relearn].

Caution
 Start the ECG Relearn during normal rhythm and when ECG signal is not noisy. If you start
an ECG Relearn during an arrhythmia period, the monitor may collect the wrong QRS
complex as the ECG template.

11-19
Chapter 12 Manual Defibrillation and Synchronized Cardioversion

12.1 Overview

This chapter introduces how to conduct manual defibrillation and synchronized cardioversion by using pads
and external paddles.
It is necessary to assess patient’s cardiac rhythm correctly and decide whether to conduct asynchronous
defibrillation or synchronized cardioversion before manual defibrillation. Select proper energy level to charge
the defibrillator. During defibrillation, the screen will display text message to indicate the users how to
operate.
In manual defibrillation mode, beside ECG, the monitor can monitor three more physiological parameter. The
physiological parameters displayed on the interface can be adjusted through [Screen Layout].
In manual defibrillation mode, if NIBP measurement is being conducted when charging the defibrillator,
NIBP measurement will stop. After shock or disarming the defibrillator, NIBP measurement will auto start if
NIBP measure mode is auto, while NIBP measurement can be started manually if the measure mode is manual.
The alarm is disabled by default when entering the manual defibrillation mode and you can press alarm pause
key to enable the alarms.

12.2 Safety Information

Danger
 Do not conduct defibrillation in the presence of oxygen-rich atmospheres. When conducting
defibrillation on the patient with oxygen catheter, place the oxygen catheter properly. Do not put
it near the pads to avoid fire and explosion.
 During defibrillation, do not allow pads to touch each other or touch ECG electrodes, lead wires,
dressings, etc. Otherwise electrical arcing and patient skin burns could be caused.
 During defibrillation, do not touch patient and conductive material (including bed and stretcher)
connected with the patient to avoid potential injury and death.
 During defibrillation, do not touch conductive liquid like saline solution, blood and conductive
gel and conductive material like bed and stretcher to avoid forming current path.
 Do not use wet hands or the hands with conductive gel to handle the paddles, or the operators
may be shocked.

Warning
 Do not use liquid conductive agent. Only the conductive gel specified by Comen can be used.
 Do not attach the paddles to your body to verify whether the paddles are connected well.
 When using the paddles, put the paddles on patient flatly and push them with equal strength. Do
not push the paddles with too much strength, or patient could be injured.
 Select appropriate defibrillation energy level for children.
 During synchronized cardioversion, if ECG waveform is obtained through external paddles, the
12-1
Manual Defibrillation and Synchronized Cardioversion

artifacts caused by paddles’ movement may be similar to R wave and trigger defibrillation
shock.

Caution
 After therapy, the conductive gel on the paddles should be cleaned immediately to prevent the
paddles from corrosion.
 The medical device which has no defibrillation protection shall be disconnected from the patient
during defibrillation.

Attention
 Too high impedance could have a great impact on patient’s therapy. Reduce the impact caused
by high impedance to the utmost. When prompt message “Impedance Too High” appears, please
check whether patient skin is clean and dry and whether chest hair has been shaved. If the
prompt message is still there, please replace pads or pads cable.
 Alarms are disabled by default when entering asynchronous defibrillation mode with text
message “Alarm Off” displayed in physiological alarm message area. You can enable alarms by
pressing alarm pause key, entering synchronized cardioversion mode or switching to monitor
mode or pacer mode.

12.3 Manual Defibrillation Interface

The manual defibrillation interface is shown as follows:

12-2
Manual Defibrillation and Synchronized Cardioversion

In defibrillation message area at the middle of manual defibrillation interface, such information about manual
defibrillation as defibrillation mode, synchronized status, energy level, impedance indicator, defibrillation
prompt message, shock times and so on will be displayed.

12.4 Steps of Manual Defibrillation

1. Remove all clothing from patient’s chest. Dry patient’s chest and do skin preparation if necessary.
2. Choose proper therapy cable and insert it into the therapy cable connector on the right panel of the
monitor until a ―click‖ is heard.
3. Place pads or paddles.
 Pads: place pads to the patient in the anterior-lateral position or anterior-posterior position
according to the indication on the packaging.
 Paddles: hold the handle of paddles with two hands and take the paddles out form the paddle tray.
Apply some conductive gel to the paddles and place them on the patient in the anterior-lateral
position.

Do not contact this


surface and the parts
below it.

Warning
 When charging or electric shock, do not touch the parts of the electrode paddle except the
insulated part of the handle, otherwise the operator may receive an electric shock.

4. Rotate the mode selector to manual defibrillation mode.


5. Select energy level and the energy level selected will be displayed in defibrillation message area.
 Turn the mode selector to the desired energy level;
 Turn the mode selector to 1-360 position and press ―+‖ and ―-‖on the monitor to adjust energy level;
if external paddle is used, you can also press ―+‖ and ―-‖ buttons on the paddle to adjust the energy.
6. Charge the defibrillator
 Press Charge button on the front panel. If external paddles are used, you can also press the Charge

12-3
Manual Defibrillation and Synchronized Cardioversion

button on the paddles. When the defibrillator is being charged, the progress bar will be displayed in
defibrillation message area and charge tone will be given out. When the defibrillator is charged well,
charge completed prompt tone will be given out.
If you want to increase or reduce the selected energy level during charge or after charge completed,
change the energy level directly and recharge the defibrillator.
Press the [Disarm] soft key to internally discharge the energy that is being charged or has been charged.
When the electric shock button is not pressed for discharge within the set auto release time, the monitor
will automatically cancel. You can set [Auto Disarm Time] under [Manul Def Setup] under the [Config
Manage] menu.
7. Shock
Make sure the patient needs to be shocked and the charge has been completed. Make sure no one contacts
with the patient and on one contacts with the accessories and equipment connected with the patient.
Shout out ―STAND CLEAR‖ loudly and clearly.
 For pads: press the Shock button on the front panel
 For external paddles: press the both Shock buttons on the paddles simultaneously.

Attention
 200J energy level is recommended for defibrillation for adult.
 When using external paddles, the Shock button on the front panel is not available.
 Usually, defibrillation is conducted by using paddles or pads. But you can choose ECG lead
wires to conduct ECG monitoring during defibrillation and any available lead can be selected
to display.

12.4.1 Using Child External Paddles

Child paddles are installed inside the external paddles. To use child paddles, press the latch in the side of
external paddles and pull the electrodes of external paddles.
For other operating steps, please refer to 12.4 Steps of Manual Defibrillation.

12.5 Synchronized Cardioversion

In manual defibrillation mode, press [Enter Sync] soft button to enter the synchronized cardioversion mode.
The synchronized state will be displayed in defibrillation message area and an R wave mark will be displayed
above each R wave detected as shown below:

Synchronized Cardioversion
12-4
Manual Defibrillation and Synchronized Cardioversion

R wave mark
ECG monitoring can be conducted by pads, paddles and also 3-lead ECG cable, 5-lead ECG cable and 12-lead
ECG cable. Use pads and paddles to give shock.
When conducting synchronized cardioversion, it is recommended to monitor ECG by using 3-lead ECG cable,
5-lead ECG cable or 12-lead ECG cable and give shock by pads and paddles.

12.5.1 Steps of Synchronized Cardioversion

1. Connect therapy cable and place pads or paddles; if using ECG lead to monitor ECG, connect ECG lead
wire and place ECG electrodes.
2. In manual defibrillation mode, press [Enter Sync] soft button. If [Remote Sync Input] of [Manul Def
Setup] is turned on, select it as required and enter synchronous cardioversion mode.
3. Select the lead. The selected lead must has clear signal and large QRS complex.
4. Make sure the R wave mark appears above the R wave. If the R wave mark doesn’t appear or appear at
the wrong position (like above T wave), select another lead.
5. Make sure the Defibrillator Monitor has entered synchronized cardioversion mode with text message
[SYNC] displayed in defibrillation message area.
6. Select energy level.
7. Press the Charge button on the panel. If you are using an external paddle, you can press the Charge
button on the paddle.
8. Make sure the patient needs to be shocked and the charge has been completed. Make sure no one contacts
with the patient and on one contacts with the accessories and equipment connected with the patient.
Shout out ―STAND CLEAR‖ loudly and clearly.
9. Press Shock button. If the external paddles are used, press both Shock buttons on the paddles
simultaneously. When the next R wave is detected, the Defibrillator Monitor will give a shock.

Attention
 The alarms will auto be enabled after enter synchronized cardioversion.
 When giving a shock, you should press and hold the Shock button (or Shock buttons on external
paddles) until the shock is delivered. The monitor will deliver the shock when the next R wave is
detected.

12.5.2 Giving Another Shock

If another synchronized cardioversion is required after giving a shock, please do the following steps:
1) Make sure that the monitor is still in synchronized cardioversion mode.
2) Repeat the 4~9 steps of synchronized cardioversion introduced above.
12-5
Manual Defibrillation and Synchronized Cardioversion

If [Sync Keep] is set to [On], the monitor will still be in synchronized cardioversion mode after giving a shock;
while if it is set to [Off], the Defibrillator Monitor will auto exit synchronized cardioversion mode after giving
a shock.

12.5.3 Exit Synchronized Cardioversion Mode

Press [Exit Sync] soft button to exit the synchronized cardioversion mode.

12.6 Remote Synchronized Cardioversion

The monitor can realize remote synchronized cardioversion by connecting with the bedside monitor. The
bedside monitor providing ECG signal must have a synchronized defibrillation connector and must be
connected with the data input/output interface of the Defibrillator Monitor through the synchronized cable.
Access [Main Menu]→[Config Manage]→enter password→[Manul Def Setup] →[Remote Sync Input] and
select [On] to enable remote synchronized cardioversion function.
Conduct remote synchronized cardioversion following the steps below:
1. Connect the bedside monitor with the Defibrillator Monitor through the synchronized cable.
2. Start the Defibrillator Monitor and enter manual defibrillation mode.
3. Press [Enter Sync] soft button and the [Sync Mode Select] menu will be displayed as shown below:

4. Select [Remote] to enter remote synchronized cardioversion mode and the text message [Remote Sync]
will appear on the screen.

5. Make sure that each time the bedside monitor detects an R wave, the mark on the monitor will flash
once, which indicates that the synchronized signal has been received once.
6. Connect the therapy cable with the monitor until a ―click‖ is heard.
7. Place pads or paddles.
8. Conduct the remote synchronized cardioversion following the step 6 through step 9 introduced in 12.5.1
Steps of Synchronized Cardioversion.

12-6
Manual Defibrillation and Synchronized Cardioversion

Attention
 After entering remote synchronized cardioversion mode, the monitor will not display ECG
waveform and parameter values of the patient. Please view the ECG waveform of the patient on
bedside monitor.
 Make sure that the bedside monitor being used has such performance that when performing
remote synchronized cardioversion, the bedside monitor and Defibrillator Monitor used
together can deliver shock synchronously within 60ms of detecting the next R wave peak.

12.7 Contact Impedance Indicator

The contact impedance indicator is used to indicate the contact impedance of the patient, as shown in the
figure below:

In which

: The contact impedance is too high.


: The contact impedance is high.
: The contact impedance is normal.
: The therapy cable is not connected well.
12-7
Manual Defibrillation and Synchronized Cardioversion

To open the contact impedance indicator, please follow the steps below:
Access [Main Menu]→[Config Manage]→enter password→[Manul Def Setup] →[Contact Imped Prompt]
and select [On] to open the contact impedance indicator.

Attention
 It is recommended to conduct defibrillation when the contact impedance is normal. The
defibrillation can also be conducted when the contact impedance is high.

12-8
Chapter 13 Noninvasive Pacing

13.1 Overview

Noninvasive pacing therapy is used to deliver rhythmical pulse to patient’s heart through the pads. When
delivering the pacing pulse once, a white pacing mark will appear on ECG waveform. In the demand pacing
mode, the white R wave mark will appear above ECG waveform until electrical capture occurs.
In pacer mode, the physiological parameters except RESP can be monitored and trigger alarms.
During demand pacing, ECG monitoring should be performed by using ECG electrodes and 3-lead, 5-lead or
12-lead ECG cable. Pacing pulse is delivered through pads, but pads are not capable of monitoring ECG and
delivering pacing pulse at the same time.

13.2 Safety Information

Warning
 For conducting pacing therapy on the patient with oxygen catheter, please place the oxygen catheter
properly and do not put it near the pads to avoid fire and explosion.
 During pacing, the heart rate and alarms given by the monitor may be inaccurate. Keep the patient
under close surveillance and do not rely entirely on the heart rate displayed on the screen.

Caution
 If pacing needs to be conducted for a long period, you should check the skin in touch with ECG
electrodes and pads and replace ECG electrodes and pads periodically.
 For conducting therapy on the patient with implanted device (like permanent pacemaker or
cardioverter-defibrillator), please consult the doctors or refer to the user manual of the
implanted device.

Attention
 Pacer mode supports arrhythmia analysis and give arrhythmia alarms including Asystole,
Ventricular Fibrillation and Ventricular Tachycardia.
 If pacing is interrupted for some reason, press [Start Pace] soft button to continue pacing.
 In pacer mode, the pacing state of the patient cannot be changed.
 If pads do not contact well, prompt message “Pacer Stopped abnormally” and “Electrode Pad
Off” will be displayed.
 In pacer mode, pads cannot be used to monitor ECG waveform.

13-1
Noninvasive Pacing

13.3 Pacing Interface

In pacer mode, the monitor can display one ECG waveform and other physiological parameters monitored. In
the pacing message area, such information related to pacing as pacing mode shortcut key, pacing message,
pacing alarm, pacing current and pacing rate will be displayed.

13.4 Pacing Mode

Two pacing modes are provided by the monitor: [Demand Pace] and [Fixed Pace].
 Demand pace: the monitor will deliver pacing pulse only when patient’s heart rate is lower than the set
pacing rate.
 Fixed pace: the monitor will deliver pacing pulse at the set pacing rate.
During pacing, you can change the pacing mode through the pacing mode shortcut key. The pacing will not
stop when changing the pacing mode and will continue to deliver pacing pulse at the set pacing rate and as the
set pacing current.

Attention
 Use demand pacing for most patients. Use fixed pacing only when there is no reliable R wave
detected or there is no available monitoring shock due to interference.

 In fixed pacing mode, there is no R wave mark above the pacing QRS complex.

 In demand pacing mode, if patient’s heart rate is higher than the pacing rate, the monitor will
not deliver pacing pulse and there will be no pacing mark either.

13-2
Noninvasive Pacing

13.5 Preparation for Noninvasive Pacing

1. Connect pads cable with the therapy cable connector on the monitor right panel.
2. Make sure that the packaging of pads is intact and pads are not expired.
3. Connect pads with pads cable.
4. Place pads on the patient in the anterior-lateral or anterior-posterior position.
5. For demand pacing mode, use ECG lead cable to monitor ECG. Connect the ECG lead cable and place
ECG electrodes. To receive the best ECG monitoring signal, make sure there is adequate space between
the ECG electrodes and pads.

13.5.1 Steps of Demand Pacing

After finishing the preparation, follow the steps below:


1. Switch to pacer mode. Demand pacing is enabled automatically and ECG waveform from lead II will be
displayed by default.
2. Select a lead with an easily detectable R-wave.
3. Make sure that the R wave mark appears above R wave, as shown below. If the R wave mark doesn’t
appear or appear at the wrong position (like above T wave), select another lead.

4. Set the pacing rate. If necessary, set the initial pacing current. Rotate the knob to outline the pacing rate
or pacing electricity hotkey and press the knob, then rotate the knob to change the pacing rate or initial
pacing current and press the knob to confirm the change or set under [Pace Setup] under the [Config
Manage] menu.

Pacing electricity Pacing rate hotkey


hotkey

5. Press [Start Pace] soft button to start pacing and the pacing message ―Being Pacing.........‖ will appear.

Attention
 In demand pacing mode, the monitor will detect the connection of pads cable, pads, ECG cable
and ECG electrodes. If any connection error is detected, the pacing will stop and relevant
prompt message will appear in the pacing message area until the connection is good.

6. Make sure the white pacing marker appears on the ECG waveform, as shown in the figure below:

13-3
Noninvasive Pacing

7. Adjust pacing current: increase the pacing current until electrical capture occurs (Electrical capture is
indicated by a QRS complex following each pacing mark), then adjust pacing current to the lowest level
which can maintain the electrical capture.
8. Confirm the peripheral circulation has a pulse.
To interrupt pacing and view patient’s pulse rate, please press and hold the [4:1] soft button. The Defibrillator
Monitor will deliver the pacing pulse at one fourth of the set pacing rate. Release the [4:1] soft key to resume
sending the pacing pulse at the set rate.
Press [Stop Pace] soft button to stop pacing. Press [Sart Pace] soft button to restart delivering pacing pulse
after pacing stops.

Caution
 The patient’s cardiac output shall be routinely evaluated.

13.5.2 Steps of Fixed Pacing

1) Enter pacer mode.


2) Select the pacing mode hotkey and switch to [Fixed Pace] mode.
Pacing mode hotkey

3) If ECG lead is used, press LEAD SELECT button to select the desired lead.
4) Set pacing rate. If necessary, set the initial pacing current.
5) Press [Start Pace] soft button to start pacing and the pacing message ―Being Pacing.........‖ will appear.
6) Make sure the white pacing marker appears on the ECG waveform, as shown in the figure below:

7) Adjust pacing current: increase the pacing current until electrical capture occurs (Electrical capture is
indicated by a QRS complex following every pacing mark), then adjust pacing current to the lowest level
which can maintain the electrical capture.
8) Confirm the peripheral circulation has a pulse.
13-4
Noninvasive Pacing

To interrupt pacing and view patient’s pulse rate, please press [4:1] soft button. The Defibrillator Monitor will
deliver the pacing pulse at one fourth of the set pacing rate. Release the [4:1] soft key to resume sending the
pacing pulse at the set rate.
Press [Stop Pace] soft button to stop pacing. Press [Start Pace] soft button to restart delivering pacing pulse
after pacing stops.

Warning
 Use pads on patient carefully to avoid shock during pacing.
 When operating the monitor on battery in pacer mode, if “Low Battery” alarm triggered, please
connect the monitor to AC power supply or replace the battery with a fully charged one
immediately.

Attention
 The monitor or pacer mode may be instable when electrotome and other electronic equipment
are used.

13-5
Chapter 14 AED

14.1 Overview

In AED (Automatic External Defibrillation) mode, the Defibrillator Monitor will analyze patient’s ECG
waveform automatically and indicate the users to operate according to the cardiac rhythm monitored.
The monitor starts to perform intelligent analysis after entering AED mode. When a shock able rhythm is
detected, the Defibrillator Monitor will give ―shock advised‖ prompt and start to auto charge immediately. If
the patient is found to be unsuitable for electric shock, enter a state where no electric shock is recommended.
Defibrillation intelligence analysis continues throughout the AED process. Defibrillation intelligence analysis
is stopped when the defibrillation monitor enters the CPR state or an abnormality occurs in the connection of
multi-functional electrode pads.
In AED mode, only the ECG signals acquired through the multi-functional electrode pads are displayed. The
monitor will turn off the alarm and parameter measurements, and it is forbidden to enter patient information.
Lead Select, Alarm Pause, NIBP, and Menu buttons are all inactive.
Before entering the AED mode to treat patients, go to the [Config Manage] → [AED Setup] screen to set the
AED routine. See 7.3 AED Settings for details.

14.2 Safety Information

Danger
 Do not conduct defibrillation in the presence of oxygen-rich atmospheres. When conducting
defibrillation on the patient with oxygen catheter, place the oxygen catheter properly. Do not put
it near the pads to avoid fire and explosion.
 During defibrillation, do not allow pads to touch each other or touch ECG electrodes, lead wires,
dressings, etc. Otherwise electrical arcing and patient skin burns could be caused.
 During defibrillation, do not touch patient and conductive material (including bed and stretcher)
connected with the patient to avoid potential injury and death.
 During defibrillation, do not touch conductive liquid like saline solution, blood and conductive
gel and conductive material like bed and stretcher to avoid forming current path.

Warning
 During defibrillation, the bubble between pads and patient skin will cause patient skin burns.
Make sure that pads are placed to patient skin tightly to avoid bubbles.
 Do not use dry pads. Use the pads immediately after unpacking them.
 AED is only applicable to the patients more than eight years old.

Caution
 For the patients with pacemaker, the sensitivity and specificity of AED analysis may decline.
 Improper operation on pads during storage or before use will damage the pads. Do not use the
damaged pads.

14-1
AED

14.3 AED Interface

AED interface is shown as the figure below:

In AED mode, the Defibrillator Monitor will only display one ECG waveform detected by pads and HR value
calculated from this displayed waveform. The AED message area at the middle of AED interface will display
AED prompt message, contact impedance indicator (settable), shock times and so on.
For the introduction to contact impedance indicator and its setting method, please refer to section 12.7
Contact Impedance Indicator for detail.
There are there soft buttons at the lower right corner of AED interface.
 When the Defibrillator Monitor is used outdoors, press [HIGH CONTRAST] soft button to view the
display screen clearly.

 Press to adjust voice volume.

14.4 AED Procedure

Verify that the patient is in cardiac arrest without consciousness, pulse or normal breathing.
1. Remove all clothing from patient’s chest. Dry patient’s chest and do skin preparation if necessary.
2. Place pads on patient in the anterior-lateral position according to the indication on packaging.
3. Connect pads with pads cable. Connect pads cable with the therapy cable connector on the Defibrillator
Monitor right panel until a ―click‖ is heard.
4. Rotate the mode selector to AED.
In AED mode, the Defibrillator Monitor will detect the connection of pads cable and pads. If any
connection error is detected, relevant prompt message will appear in the AED message area until the
connection is good.
5. Perform AED following the voice prompt and prompt message.

14-2
AED

The monitor will analyze patient’s cardiac rhythm based on the ECG waveform detected by pads and
give a warning of ―Not Contact Patient‖. When a shock able rhythm is detected, the Defibrillator Monitor
will start to auto charge immediately.
The voice prompt can be enabled or disabled in [Config Manage] menu or by pressing the soft button
below .
6. If there is a shock advised, press the Shock button on the front panel.
After charge completes, the monitor will give out ―Do not touch patient! Press shock button‖ voice
prompt. At this moment, check that no one touches the patient and accessories or equipment connected
with the patient and shout out ―STAND CLEAR‖ loudly and clearly. Then press the Shock button on the
front panel to deliver a shock.
After shock, the monitor will give ―Energy Delivered‖ voice prompt and text message. The shock times on the
screen will update to indicate the number of shocks has been delivered. If the [Serial Shock Times] is set as
more than one, the monitor will restart to analyze patient’s cardiac rhythm after a shock being delivered and
estimate whether the shock is successful. There will be voice prompt and text message for indicating the users
to perform more shocks.

Attention
 Do not place pads in the anterior-posterior position. The AED algorithm of this monitor has
not been verified under the anterior-posterior placement.
 Keep patient still during cardiac rhythm analysis in order to prevent misdiagnosis and delayed
diagnosis.
 The monitor will not deliver shocks automatically. Shocks will only be delivered by pressing
Shock button.
 Too high impedance could have a great impact on patient’s therapy. Reduce the impact caused
by high impedance to the utmost. When prompt message “Impedance Too High” appears,
please check whether patient skin is clean and dry and whether chest hair has been shaved. If
the prompt message is still there, please replace pads or pads cable.

14.5 Shock Advised

If the shock able cardiac rhythm is detected, the defibrillator will be auto charged to the set energy level and
charge tone will be given out. The Shock button will flash after charge completes.

14-3
AED

The cardiac rhythm analysis will continue during charge. If the situation that the cardiac rhythm has changed
and is not suitable for shock before delivering a shock is detected, the defibrillator will disarm the energy
automatically.
After the monitor gives out voice prompt ―Do not touch patient! Press shock button.‖, if the users do not press
Shock button during the interval set in [Auto Disarm Time], the defibrillator will disarm the energy
automatically and restart cardiac rhythm analysis.
Press [Pause Analysis] soft button to disarm the defibrillator at any time during charge or after charge
completes.
Initial shock energy recommended for adult patient is 200J.

14.6 No Shock Advised

When there is no shock able rhythm detected, the monitor will give ―No Shock Advised!‖ prompt message.
If NSA process mode is set as:
 [CPR]: Enter CPR, the monitor will give out voice prompt ―No shock advised, Pause, if needed, start
CPR‖ and display text prompt ―Pause, If Needed, Begin CPR‖ in AED message area. CPR countdown
will also appear.
 [Continue Analysis]: The monitor will continue to monitor patient’s ECG and analyze the potentially
shock able cardiac rhythm. Before shock able cardiac rhythm being detected, the monitor will give out
voice prompt ―No shock advised. If needed, pause analysis for CPR‖ repeatedly and display ―No Shock
Advised!‖ and ―Being Monitoring....‖ text prompt circularly. The frequency of the language prompt can
be set in [Voice Interval] in [AED Setup].
You can press [Pause Analysis] soft button to stop analysis and start CPR. [CPR Time] can be set in [AED
Setup].

After CPR, the monitor will resume analysis, or during CPR, you can press [Recovery Analysis] soft button to
resume cardiac rhythm analysis.

14.7 CPR

If the [Pre-Shock CPR Time] isn’t set to [Off], the system will enter initial CPR after entering AED mode.
The users can set the pre-shock CPR time or disable the initial CPR function in [Pre-Shock CPR Time].
After finishing the serial shocks, the monitor will pause analysis and enter CPR. The CPR countdown will
start and voice prompt ―Pause, If Needed, Begin CPR‖ will be given out. After CPR, the monitor will resume
analysis. During CPR, you can press [Recovery Analysis] soft button to resume cardiac rhythm analysis.
During serial shocks, if you press [Pause Analysis] soft button after a shock delivered, the monitor will enter
CPR. The CPR duration can be set in [CPR Time] in [AED Setup].

14-4
AED

14.7.1 Using CPR Metronome

After enter CPR, the monitor provides the CPR metronome function and indicates the operators to press the
patient’s chest 120 times per minute which is recommended by AHA/ERC and perform ventilation.
You can enable and disable the CPR metronome function in [CPR Metronome] in [AED Setup].
The CPR metronome is turned on by default. With the CPR metronome turned on, you can set the CPR
compression/ventilation ratio by selecting [CPR Mode]. The default compression/ventilation ratio is 30:2.

Warning
 CPR metronome doesn’t prompt the current condition of the patient. The operators should assess
patient’s condition constantly because patient’s condition may vary in a very short period. Do not
perform CPR on the patients with response and normal breathing.

Attention
 CPR metronome can be affected by the on/off state of AED voice prompt and the settings of
voice volume.

14.8 AED Audio Recording

In AED mode, the system can tape the whole therapy process.
You can enable the audio recording function by accessing [Config Manage]→[AED Setup]→[Audio
Recording]and select [On].
After audio recording function is enabled, symbol will appear at the upper right corner of the AED
message area.
The system can store audio recording up to 240 min and store audio recording of 60 min for each patient.

14-5
Chapter 15 Resp Monitoring

15.1 Resp Measurement

The monitor measures the RESP based on the thoracic impedance between the two electrodes. The changes of
such impedance caused by thoracic movements generate a RESP wave on the screen. The RR is calculated
from such wave.

15.2 Resp Display

1 3

2
1. Resp Waveform 2. Resp Alarm Limit 3. Value

15.3 Placement of Electrodes

In Resp measurement, it is important to prepare the skin properly for electrode placement. Refer to the ECG
measurement for relevant information.
The Resp signals are measured through the two ECG electrodes. When the ECG electrodes are placed in
standard position, the Resp can be measured through the electrode RA and electrode LL.

15.3.1 Optimization of Lead Position

To measure the ECG and Resp simultaneously, it may be necessary to adjust the positions of the two
electrodes for some patients. Non-standard placement of ECG electrodes may cause changes to the ECG
waveform and affect the ST segment analysis and ARR analysis.
1) Cardiac Superposition
The cardiac activities affecting the Resp waveform are defined as cardiac superposition. When that the Resp
electrodes collect the rhythmic blood flow causes the impedance changes, the phenomenon occurs. Proper
placement of electrodes can reduce cardiac superposition. Avoid the liver area and ventricles in the line
between the electrodes, which is especially important to neonates.

15-1
Resp Monitoring

2) Lateral Thoracic Expansion


The thoracic cage of some patients, especially neonates, may expand to both sides. To obtain the best Resp
waveform, place the two electrodes respectively at the right mid-axillary line and left outer chest with
strongest Resp movements, as shown below:

3) Abdominal Respiration
Some patients may have restricted thoracic movements and rely mainly on abdominal respiration. To obtain
the best Resp waveform, place the electrode LL on the left abdomen with strongest expansion, as shown
below:

Attention

 Place the green and red electrodes diagonally for the best respiratory wave. The liver region
and ventricle should be avoided by connecting them to the respiratory electrodes, so as to avoid
the false difference of cardiac coverage or pulsating blood flow, which is especially important
for newborns.

 Respiratory monitoring is not appropriate for patients with a high range of activity because it
can lead to false alarms.

15.4 Resp Calculation Mode

1) Enter [User Maintain] → [Resp Setup] → [Cal. Mode] (Calculation Mode).

2) Select [Auto] or [Manual].

3) In [Manual] mode, you can set the upper and lower dotted line of the Resp waveform.

4) In [Auto] mode, you cannot change the upper or lower dotted line but use the default waveform

computation method.

15-2
Resp Monitoring

[Auto] mode:
The monitor automatically adjusts the detection level based on the waveform height and ECG artifact. In
[Auto] mode, no dotted line of detection level is displayed on the Resp waveform.
Select [Auto] mode if:
 The RR is not approximate to the HR;

 The patient relies on spontaneous Resp with or without CPAP;

 The patient relies on mechanical ventilation (except intermittent mandatory ventilation (IMV)).
[Manual] mode:
In [Manual] mode, you have to set the Resp detection level. The monitor does not auto adjust the dotted lines
of detection level. When the Resp depth changes or the Resp waveform gain is adjusted, you may need to
adjust the position of the dotted lines of detection level on the Resp waveform manually by selecting [Up Line]
and [Down Line].
Select [Manual] mode if:
 The RR is approximate to the HR;

 The patient relies on IMV;

 The Resp signals are weak (try to improve the signal quality by relocating the electrodes).
In [Manual] mode, the superposition of some cardiac activities may trigger the Resp counter and result in
incorrect high RR indication or no-breath detection failure. If you doubt that the cardiac superposition has
been treated as Resp activities, improve the RESP detection level until it is higher than the cardiac
superposition. If you do not improve the Resp detection level due to small Resp waveform size, follow the
instructions of Lateral Thoracic Expansion in Section 15.3.1 Optimization of Lead Position to optimize the
position of the electrodes.

15.5 Resp Setup

15.5.1 Gain

Gain is used to adjust the amplitude of the Resp wave. You can select ×0.25, ×0.5, ×1, ×2 or ×4 as the gain.
1) Select the Resp parameter area to enter [Resp Wave] and select an appropriate [Gain].

15.5.2 Resp Lead

Resp leads indicate the source of the current Resp waveform. You can set [Resp Lead] to RA-LA (I), RA-LL
(II) or [Auto]. If you select [Auto], the monitor automatically selects the appropriate Resp lead.
1) Select the Resp parameter area to enter [Resp Setup] → [Resp Lead].

2) Select RA-LA (I), RA-LL (II) or [Auto].

15-3
Resp Monitoring

15.5.3 No Breath Alarm Delay

No-breath detection is to detect the longest interval between two respirations. When the actual no-breath time
of the patient exceeds the set no-breath time, the monitor responds to no-breath alarms according to the value
of [No Breath Alm Delay].
Set [No Breaths Timeout]:
1) Select the Resp parameter area to enter [Resp Setup] → [No Breaths Timeout] and set an appropriate

detection time.
Set [No Breath Alm Delay]:
1) Enter [User Maintain] → [Other Setup].

2) Set [No Breath Alm Delay] to [Close], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or

[1min].
If you select [Close], the alarm delay function will be disabled.

15.5.4 Enhance Filter

This parameter is designed to filter out the Resp interference. Its default is [On].
1) Select the Resp wave area to enter [Resp Wave].

2) Select [Enhance Filter] to switch between [ON] and [OFF].

Note
 In Resp measurement, the monitor cannot recognize any obstructive or mixed nobreathing but
trigger an alarm when the interval between two respirations exceeds the set time.

15-4
Chapter 16 SpO2 Monitoring

16.1 Overview

The SpO2 plethysmography measures the arterial SpO2, namely, the percentage of the oxyhemoglobin count.
The SpO2 is measured with the pulse oximetry; a continuous noninvasive method measuring how many of the
lights emitted from the sensor (light source) can penetrate the patient’s tissues (fingers or ears) and reach the
receiver.
The monitor measures the following parameters:
Arterial SpO2: the ratio of the oxyhemoglobin to the sum of oxyhemoglobin and non-oxygenated hemoglobin
(functional arterial SpO2);
Pleth waveform: a visible indication of the patient’s pulse;
PR (calculated from pleth waveform): the patient’s pulse count per minute;
PI (perfusion index, not for Nellcor SpO2): pulse signal strength as the percentage of pulsatile signal to non-
pulsatile signal.

Warning
 If there is any carboxyhemoglobin (COHb), methemoglobin (MetHb) or dye dilution
chemical, the SpO2 value has a deviation.

16.1.1 Identification of SpO2 Sensor Type

The SpO2 sensor type is pre-configured before the monitor is delivered. You can identify it based on the
silkscreened logo beside the original SpO2 sensor below the left side sensor connector of the monitor:
 Comen SpO2 sensor:
Sensor connector: circular white connector at the side panel;
Silkscreened logo: SpO2.
 Masimo SpO2 sensor:
Sensor connector: circular blue connector at the side panel;
Silkscreened logo: MasimoSET.
 Nellcor SpO2 sensor:
Sensor connector: circular blue connector at the side panel;
Silkscreened logo: Nellcor.
The information about wavelength range and maximum optical output power of the sensor is useful to the
clinician for some therapy, for example, photodynamic therapy.
 The Comen SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

16-1
SpO2 Monitoring

 The Masimo SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

 The Nellcor SpO2 sensor can measure a wavelength of 660nm (red LED) or 905nm (IR LED).

 The maximum optical output power of the sensor is lower than 15mW.

Warning
 The monitor can automatically recognize the SpO2 sensor type. However, the monitor is
connfigured with a specific internal SpO2 hardware before delivery, the monitor cannot
measure SpO2 if using a incompatible sensor.

16.2 SpO2 Display

Pleth waveform Signal Identification and Quality Alarm limit SpO2 value PI value

16.3 Safety Instructions

Warning
 The monitor is compatible with the SpO2 sensor designated by Comen only. Before monitoring
the patient, check the sensor and extension cord are compatible with the monitor. Incompatible
accessories reduce the performance of the monitor.
 Before monitoring the patient, check the sensor cable works properly. Remove the SpO2 sensor
cable from the sensor interface and the monitor displays the prompt message “SpO2Finger off”
and triggers the alarm sound.
 If the SpO2 sensor or its package seems damaged, do not use it. Return the damaged product to
the manufacturer.
 Long-time continuous monitoring increases the risk of undesired skin characteristic changes
(extremely sensitive, turning red, blistered or pressure necrosis), especially for neonates or the
patients with perfusion disorder or variable or immature skin morphology diagram. Align the
sensor with the light path, adhere the sensors properly and check the sensors position regularly
based on skin quality (change the sensor position when the skin quality decreases). Perform such
check frequently if necessary (subject to the condition of the patient).
 Make sure the sensor cable and the electrosurgical equipment cable are not intertwined.
 Do not place the sensor on a limb with ductus arteriosus or intravenous tube.
 Setting the high SpO2 alarm limit to 100% disables the high-limit alarm. Premature infants may

16-2
SpO2 Monitoring

get infected with crystalline posterior fibrous tissue diseases in case of high SpO2. Please set the
high SpO2 alarm limit cautiously based on recognized clinical practices.
 The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.
 As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
 Do not place the pulse oximeter or accessories in any position where it might fall on the patient.
 Do not start or operate the pulse oximeter unless the setup was verified to be correct.
 Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI
environment.
 Do not use the pulse oximeter if it appears or is suspected to be damaged.
 Explosion hazard: Do not use the pulse oximeter in the presence of flammable anesthetics or
other flammable substances in combination with air or nitrous oxide or in oxygen-enriched
environment.
 To ensure safety, avoid stacking multiple equipment or placing anything on the equipment
during operation.
 To protect against injury, follow the directions below:
 Do not soak or immerse the equipment in liquids.
 Do not attempt to sterilize the equipment.
 Use cleaning solutions only as instructed in this operator's manual.
 Do not attempt to clean the equipment while monitoring a patient.
 To protect from electric shock, always remove the sensor and completely disconnect the pulse
oximeter before bathing the patient.
 If any measurement seems questionable, first check the patient’s vital signs by alternate means
and then check the pulse oximeter for proper functioning.
 Inaccurate SpO2 readings may be caused by:
 Improper sensor application and placement.
 Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a
seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory
analysis (CO-Oximetry) of a blood sample should be performed.
 Elevated levels of bilirubin.
 Elevated levels of dyshemoglobin.
 Vasospastic disease, such as Raynaud’s, and peripheral vascular disease.
 Hemoglobinopathies and synthesis disorders such as thalassemias, such as thalassemias,
Hbs, Hbc, sickle cell, etc.
 Hypocapnic or hypercapnic conditions.
 Severe anemia
 Very low arterial perfusion.

16-3
SpO2 Monitoring

 Extreme motion artifact.


 Abnormal venous pulsation or venous constriction.
 Severe vasoconstriction or hypothermia.
 Arterial catheters and intra-aortic balloon.
 Intravascular dyes, such as indocyanine green or methylene blue.
 Externally applied coloring and texture, such as nail polish, acrylic nails, glitter, etc.
 Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers.
etc.
 Skin pigment disorders.
 Interfering Substances: Dyes or any coloring substance that can change usual blood
pigmentation may cause erroneous readings.
 The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in
conjunction with clinical signs and symptoms.
 The pulse oximeter is not an apnea monitor.
 The pulse oximeter may be used during defibrillation, but this may affect the accuracy or
availability of the parameters and measurements.
 The pulse oximeter may be used during electrocautery, but this may affect the accuracy or
availability of the parameters and measurements.
 The pulse oximeter should not be used for arrhythmia analysis.
 SpO2 is empirically calibrated in healthy adult volunteers with normal levels of
carboxyhemoglobin (COHb) and methemoglobin (MetHb).
 Do not adjust, repair, open, disassemble, or modify the pulse oximeter or accessories. Injury to
personnel or equipment damage could occur. Return the pulse oximeter for service if necessary.
 Check the patient’s skin every two hours to ensure good skin quality and lighting. In case of any
skin change, move the sensor to another part. Change the wearing part at least every four hours.

Cautions
 Do not place the pulse oximeter where the patient can control it.
 Electrical shock and flammability hazard: Before cleaning, always turn off the equipment and
disconnect from any power supply.
 When patients are undergoing photodynamic therapy they may be sensitive to light sources.
Pulse oximeter may be used only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.
 Do not place the pulse oximeter on electrical equipment that may affect the normal work of the
oximeter equipment
 If SpO2 values indicate the possibility of the hypoxemia, a laboratory blood sample should be
taken to confirm the patient’s condition.
 If using pulse oximeter during full body irradiation, keep the sensor out of the radiation field. If

16-4
SpO2 Monitoring

the sensor is exposed to the radiation, the reading might be inaccurate or the equipment might
be zero for the duration of the active irradiation period.
 To ensure that alarm limits are appropriate for the patient monitored, check the limits each time
the pulse oximeter is used.
 Variation in measurements may be profound and may be affected by sampling technique as well
as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s
clinical status should be repeated and/or supplemented with additional test data. Blood samples
should be analyzed by laboratory instruments prior to clinical decision made to completely
understand the patient’s condition.
 Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilize by autoclave,
irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse
oximeter.
 Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-
applied circuits and the system are within acceptable limits as specified by the applicable safety
standards. The summation of leakage currents must be checked and in compliance with IEC
60601-1 and UL60601-1. The system leakage current must be checked when connecting external
equipment to the system. When an event such as a component drop of approximately 1 meter or
greater or a spillage of blood or other liquids occurs, retest before further use. Injury to
personnel could occur.
 Disposal of product - Comply with local laws in the disposal of the equipment and/or its
accessories.
 To minimize radio interference, other electrical equipment that emits radio frequency
transmissions should not be in close proximity to the pulse oximeter.

Notes
 High-intensity extreme lights (such as pulsating strobe lights) directing on the sensor may not
allow the pulse oximeter to provide vital sign readings.

16.3.1 Masimo SpO2 Specific Information

Cautions
 If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In
the interim, assess the patient and, if indicated, verify oxygenation status through other means.
 Replace the cable or sensor if the instructions in the manual after firstlytried don't work when a
low SIQ message is displayed in the process of consistently monitoring patients. after completing
troubleshooting steps listed in this manual.

16-5
SpO2 Monitoring

Notes
 When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be
compromised. If the equipment is in this setting and the sensor becomes dislodged from the
patient, the potential for false readings may occur due to environmental "noise" such as light,
vibration, and excessive air movement.
 Do not loop the patient cabling into a tight coil or wrap around the equipment, as this can
damage the patient cabling.
 Additional information specific to the Masimo sensors compatible with the pulse oximeter,
including information about parameter/measurement performance during motion and low
perfusion, may be found in the sensor's directions for use (DFU).
 Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate
readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the
specified duration of the patient monitoring time.

16.4 SpO2 Accuracy Test

Warning
 A functional tester cannot be used to assess the accuracy of the pulse oximeter.

Assess the SpO2 accuracy by comparing the readings respectively on the monitor and CO-oxygen pressure
gauge.

16.5 Low Perfusion Accuracy Test

This monitor measures low perfusion and the recommended method of determining the low perfusion
accuracy of the monitor is to conduct this test with CO-oximeter on adult volunteers whose SpO2 ranges from
70% to 100%. The accuracy index is obtained according to statistical distribution, and only about 2/3 of the
estimated values are expected to fall within the estimated values of CO-oximeter.

16.6 PR Accuracy Test

Assess the PR accuracy by comparing with the ECG heart rate.

16-6
SpO2 Monitoring

16.7 Monitoring Steps

Warning
 Place the SpO2 sensor properly based on the SpO2 sensor type. This is especially important
for neonates.

Monitor SpO2:
1) Set the patient type;

2) Insert the SpO2 cable connector into the SpO2connectorof the monitor;

3) Place the sensor to an appropriate position on the patient’s finger.

Fig 16-1Placement of SpO2 Sensor

Monitor SpO2 for neonates:


The SpO2 for neonates is almost the same as that for adults. The neonatal SpO2 sensor and its placement is
provided below.
 Neonatal SpO2 Sensor
The neonatal SpO2 sensor consists of the Y-shaped SpO2 sensor and neonatal SpO2 sensor cover. Insert the
LED end and PD end of the Y-shaped SpO2 sensor respectively to the upper and lower slot of the neonatal
SpO2 sensor cover as shown in Fig. 16-2. The assembled neonatal SpO2 sensor is shown in Fig. 16-3.

Y-shaped SpO2Sensor Neonatal SpO2 Sensor Cover

Fig 16-2Neonatal SpO2 Sensor

16-7
SpO2 Monitoring

Fig 16-3Neonatal SpO2 Sensor

 Placement of Neonatal SpO2 Sensor


Clip the SpO2 probe to the newborn's hand or foot (as shown in Figure 16-4). Hold the SpO2 probe, pull the
strap and place the 'V' shaped edge on one side of the strap into the 'V' shaped slot on the corresponding side
of the sheath. Properly stretch the strap (about 20 mm or so) and place the 'V' shaped edge on the other side of
the strap into the 'V' shaped slot on the other side of the sheath. Then loosen the strap and thread the strap into
the first latch to lock the strap with the 'V' shaped edges on both sides of the strap and the 'V' shaped slots on
both sides of the sheath. If the strap is too long, it can be threaded into the second latch. The SpO2 probe must
be positioned so that the optoelectronic component can be in the correct facing position. Also, be careful not
to pull the strap too long, as this will result in inaccurate measurements and severe blockage of blood
circulation.

Fig 16-4Placement of Neonatal SpO2 Sensor

16.8 Measurement Restrictions

In operations, the following factors may affect the SpO2 measurement accuracy:
1) High-frequency radio interference, whether from the monitor or from the electrosurgical equipment

connected to the monitor. To minimize radio interference, other electrical equipment that emits high-

frequency transmission should not be in close proximity to the monitor.

2) Do not use the oximeter or SpO2 sensor during MRI scanning, or the induced current may cause burns.

3) Intravenous dyes.

4) The patient moves frequently.

16-8
SpO2 Monitoring

5) Ambient ray radiation.

6) The sensor is fixed improperly or in an improper position on the patient.

7) Improper sensor temperature.

8) The sensor is placed on a limb with blood pressure cuff, ductus arteriosus or intravenous tube.

9) Concentration of the non-functional hemoglobin, like COHb or MetHb.

10) Low SpO2.

11) Poor circulation perfusion at the tested part.

12) The shock, anemia, hypothermia and vasoconstrictors may reduce the arterial blood flow to a level that is

not measureable.

13) The SpO2 measurement accuracy depends also on the absorption of the lights with special wavelength by

oxyhemoglobin and reduced hemoglobin. If any other substance also absorbs such lights, like COHb,

MetHb, methylene blue or indigo carmine, you may obtain a false or low SpO2 value.

16.9 SpO2 Setup

16.9.1 Set Off Level

Enter [User Maintain] → [Alarm Setup] → [SpO2 Sensor Off Level].

16.9.2 Smart Alarm

1) Select the SpO2 parameter area to enter [SpO2 Setup] → [SatSecond] (Saturation Seconds).

2) Select [10], [25], [50], [100] or [Not Allowed].


Note: this function is available for NELLCOR SpO2 only.

The smart alarm is designed to reduce false alarms and keep the clinician informed of the SpO2 changes more
accurately and timely. For example, if you set [Sat second] to [50] and the high and low alarm limit of
NELLCOR SpO2 respectively to 97% and 90%, and the measured SpO2 value keeps at 80% for 3s and then to
78% for 2s, the monitor will provide audible and visual alarm indications 5s after the SpO2 value goes beyond
the alarm limit and the circle beside the SpO2 value will return to the origin.
Calculation method:
Percentage points × seconds = Sat second (integer)
The calculated Sat second is displayed as follows:
% SpO2 Seconds Sat second
(90%-80%) × 3 = 30
(90%-78%) × 2 = 24

16-9
SpO2 Monitoring

Total Sat second = 54

Fig 16-5AnExample

In the above Sat second example:


About 4.9s later, the monitor will report a Sat second alarm because you’ve set [Sat second] to [50], smaller
than 54.
The SpO2 value may fluctuate for a few seconds rather than remain unchanged. Usually the patient’s SpO2
value fluctuates within the alarm limit and sometimes goes beyond the alarm limit. The monitor accumulates
the positive and negative percentage points until the set value of [Sat second] is reached or the patient’s SpO2
value remains within the alarm limit.

16.9.3 Smart Pulse Tone

If smart pulse tone is enabled, you can hear the pulse tone even when the signal is unstable or the equipment is
in a noisy environment. You won’t hear the pulse tone in the case of unstable signal or ambient noise if this
function is disabled.
Set [Smart Tone]:
1) Select the SpO2 parameter area to enter [SpO2 Setup].

2) Select [Smart Tone] to switch between [ON] and [OFF].


Note: this function is available for Masimo SpO2 only.

16.9.4 NIBP Same Side

Set [NIBP Same Side]:


1) Select the SpO2 parameter area to enter [SpO2 Setup].

2) Select [NIBP Same Side] to switch to [ON].

16-10
SpO2 Monitoring

If you do not select [ON], the weak perfusion caused by NIBP measurement leads to inaccurate SpO2
measurement or trigger aphysiologicalSpO2 alarm when the NIBP measurement and SpO2measurement
are performed on the same limb.

16.9.5 Set Signal IQ

The magnitude of the SpO2 SIQ waveform provides an assessment of the confidence in the measurement
displayed. A higher value indicates higher confidence in the measurement whereas a smaller value indicates
lower confidence in the displayed measurement.
Movements usually affect the signal quality. When the arterial pulse reaches the peak, the monitor marks its
location on the vertical line (signal indicator). The smart tone volume (if enabled) remains consistent with the
indication in the vertical line (the volume of the smart tone will increase or decrease accordingly when the
SpO2 value increases or decreases).
The height of the vertical line represents the quality of the measured signal (the higher line, the higher quality).
Set [Signal IQ] (Signal Identification and Quality):
1) Select the SpO2 parameter area to enter [SpO2 Setup].

2) Select [Signal IQ] to switch between [ON] and [OFF].


Note: this function is available for Masimo SpO2 and simulated SpO2 only.

16.9.6 Average Time

The SpO2 value displayed on the monitor is the average of the SpO2 values acquired in a given time. Shorter
(longer) average time will lead to quicker (slower) response and lower (higher) measurement accuracy of the
monitor when the patient’s SpO2 value changes. For a critical patient, please set a short average time so as to
analyze his/her condition timely. Set average time:
Masimo SpO2:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Average Time].

2) Select [2-4s], [4-6s], [8s], [10s], [12s], [14s] or [16s].


Comen SpO2:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Sensitivity].

2) Select [High], [Medium] or [Low].

16.9.7 Fast Sat

FastSat enables rapid response to, and display of, fast changes in SpO2 by giving priority to the most recent
data. This aids the clinician in clinical settings requiring fast response time such as those seen with induction,
intubation, sleep studies and resuscitation.

16-11
SpO2 Monitoring

1) Select the SpO2 parameter area to enter [SpO2 Setup].

2) Select [Fast Sat] (Fast Saturation) to switch between [On] and [Off].
Note: this function is available for Masimo SpO2 only; if this function is enabled, you can find the
prompt message “Fast Sat” at the main screen.

16.9.8 Sensitivity

[Sensitivity] can be set to [Normal], [Maximum] or [APOD] (Adaptive Probe Off Detection). [Maximum]
represents the highest sensitivity. In typical monitoring conditions, select [Normal]. If the sensor is likely to
fall off the patient due to wet skin, violent movement or other causes, select [Maximum]. If the patient’s
perfusion level is extremely low, select [APOD].
Set [Sensitivity]:
1) Select the SpO2 parameter area to enter [SpO2 Setup] → [Sensitivity].

2) Select an appropriate [Sensitivity]: [Normal], [Maximum] or [APOD].

Note: this function is available for Masimo SpO2 only.

16.10 Masimo Information

1) Masimo Patent Information


Masimo Patents: www.masimo.com/patents.htm
2) No Implied License Statement
Possession or purchase of this equipment does not convey any express or implied license to use the equipment
with unauthorized sensors or cables which would, alone or in combination with this equipment, fall within the
scope of one or more of the patents relating to this equipment.
3) Other Information
©2006 Masimo Corporation. Masimo, Radical, Discrete Saturation Transform, DST, Satshare, SET, LNOP,
LNCS and LNOPv are federally registered trademarks of Masimo Corporation.
RadNet, Radicalscreen, signal IQ, FastSat, fastStart and APOD are trademarks of Masimo Corporation.

16-12
Chapter 17 NIBP Monitoring

17.1 Overview

NIBP monitoring is applicable to adults, children, neonates, pregnant women and pre-eclampsia patients
The monitor uses the vibration method (measuring the cuff pressure vibration amplitude) to measure the
noninvasive blood pressure (NIBP). Blood pressure changes cause the cuff vibration. The pulse wave range
varies from the cuff pressure and when the maximum pulse wave range is obtained, according to the
corresponding proportionality calculating the pulse wave ranges of systolic and diastolic pressure, the systolic
pressure and diastolic pressure can be obtained. The BP values measured by this equipment are equivalent to
the values measured by invasive method. The error complies with the requirements of IEC80601-2-30. The
brachial artery is selected for verification in the clinical trials using the invasive method.
When making measurements on children and newborns, it must be ensured that the correct mode setting has
been selected (see Patient Information Menu Settings). Using the wrong patient mode may jeopardize patient
safety as higher adult blood pressure levels are not applicable to children and newborns.
NIBP measurement can be applied in electrosurgical operations and defibrillator discharges according to
IEC80601-2-30.

17.1.1 NIBP Display

The NIBP measurement results are displayed in the parameter area. The figure below is for reference only.
The actual display may be slightly different from this figure.

② ⑥ ③ ④

⑦ ⑤

① Alarm limit of systolic pressure ② Time of the previous measurement

③ Patient type: ADU, PED or NEO. ④ Pressure unit: mmhg or kPa


Measurement mode: auto, manual or
⑤ Diastolic pressure ⑥
continual.
⑦ Systolic pressure

17-1
NIBP Monitoring

17.2 Safety Instructions

Warning
 Before the NIBP measurement, make sure the selected monitoring mode is appropriate for the
patient (adult, pediatrics or neonate). It is dangerous to select a non-neonatal mode for
neonatal patients.
 Do not place the cuff on a limb with intravenous infusion or cannula in place, or the tissues
around the cannula may be damaged when the infusion is slowed or blocked in the cuff
inflation process.
 Make sure the inflation tube connecting the blood pressure cuff to the monitor is not obstructed
or entangled.
 Do not perform the NIBP measurement to a patient with sickle cell disease or existing or
expected skin lesions.
 For a patient with severe disturbances of blood coagulation, please determine the applicability
of automatic NIBP measurement based on clinical evaluation, or the limb contacting the cuff
may suffer from hematoma due to friction.
 Frequent measurements could cause blood flow disturbance and injure the patient.
 To prevent further injury, do not place the cuff on any wound.
 Do not place the blood pressure cuff on a limb under intravenous infusion, intravenous therapy
or arteriovenous shunt, or the transient blood flow disturbance will injure the patient.
 Do not place the cuff on the arm at the same side as mastectomy.
 The increasing cuff pressure could cause transient function failure to other monitoring
equipment used on the same limb.

17.3 NIBP Measurement

17.3.1 Preparations for Measurement

1) Connect the inflation tube to the blood pressure cuff.

2) Connect the inflation tube to the NIBP connector of the monitor without compressing or blocking the

pressure tube.

3) Use the correct size cuff and make sure the airbag is not folded or twisted.

 An incorrect cuff size or a folded or twisted airbag causes inaccurate measurement. Make sure the

cuff is deflated thoroughly. The cuff width should be 40% (50% for neonates) of the limb perimeter

or 2/3 of the upper arm length. The inflated part of the cuff should be long enough to circle 50~80%

17-2
NIBP Monitoring

of the limb.

4) Wrap and secure the cuff around the limb and make sure the cuff is at the same level as the patient’s

heart. If you fail to do so, use the following methods to correct the measurement result:

 Make sure the mark ―φ‖ is located at an appropriate artery. Do not wrap or secure the cuff too

tightly, or the distal extremity may suffer from discoloration or ischemia. Regularly check the skin

condition of the contact part and the color, temperature and feeling of the limb which wears the cuff.

If the skin condition changes or the blood circulation of the limb is affected, move the cuff to

another body part for continued measurement or stop the NIBP measurement immediately. In auto

measurement mode, observe the skin condition frequently.

 If the cuff is not at the same level as the heart, use the following correction formulas:

 If the cuff is at a higher level than the heart: displayed NIBP value + 0.75mmHg (0.10kPa) ×

level difference (cm).

 If the cuff is at a lower level than the heart: displayed NIBP value - 0.75mmHg (0.10kPa) × level

difference (cm).

17.3.2 Measurement Restrictions

The vibration method has some restrictions, depending on the patient’s condition. The vibration method
detects the regular pulse wave generated by arterial pressure. If the patient’s condition makes it difficult to
detect such waves, the measured pressure value is unreliable and the pressure measurement time increases. In
the following cases, the pressure measurement is affected.
1) Patient Movement
If the patient is moving, trembling or under cramps, which may affect the detection of arterial pressure pulse,
the NIBP measurement is unreliable or impossible and the pressure measurement time will increase.
2) Arrhythmia
If the patient has irregular heartbeats due to arrhythmia, the NIBP measurement is unreliable or impossible
and the pressure measurement time increases.

17-3
NIBP Monitoring

3) Heart-lung Machine
Do not perform the NIBP measurement if the patient is connected to a heart-lung machine.
4) Pressure Changes
If the patient’s blood pressure changes rapidly within a certain time when the monitor analyzes the arterial
pressure pulse for measurement purpose, the NIBP measurement is unreliable or impossible.
5) Severe Shock
If the patient is under severe shock or hypothermia, the NIBP measurement is unreliable as the reduced blood
flow to the periphery will cause lower arterial pulse.
6) Extreme HR
Do not perform the NIBP measurement if the HR is lower than 40bpm (beats per minute) or higher than
240bpm.
7) Obese Patient
Due to the thick fat layer of the limb, the vibration from the artery fails to reach the cuff, which causes lower
measurement accuracy than in normal weight cases.
8) Patient with Hypertension
To measure the NIBP of a patient with hypertension accurately, follow the steps below:
 Adjust his/her sitting posture until:

 He/she sits comfortably;

 His/her legs are not crossed;

 His/her feet are laid flat on the ground;

 He/she leans his/her back against the chair and puts his/her hands on the desk;

 The middle part of the cuff is at the same level as his/her right atrium.

 Ask the patient to relax as much as possible and not talk during the measurement.

 5 min elapses before the first reading is taken.

17.3.3 Start the Measurement

17.3.3.1 Start the Manual Measurement

Select the NIBP parameter area to enter the setup menu→[Measure Mode]→[Manual] or select quick key
[Mode Setup], then select [Manual]. Whether to start the NIBP measurement depends on the user’s need.

17.3.3.2 Start the Whole Point Measurement

1. Select the NIBP parameter area to enter the setup menu→[Whole point Mea.], and switch it to ―On‖.

17-4
NIBP Monitoring

2. Select the [NIBP] key on the control panel and manually start the first measurement. After the first

measurement, the monitor will automatically and repeatedly start the measurement according to the

interval time set before.


For example, if you start the first measurement at 08:23, and set [Interval] to [5min], the monitor will operate
the next measurement at 08:25. The measurement will start in synchronization with the clock, and then at
08:30 by parity of reasoning.

Note
 The monitor operate the [Whole point Mea.] only when the [Interval] is not less than 5min.

17.3.3.3 Start the Interval Measurement

1. Select the NIBP parameter area to enter the setup menu→[Measure Mode]→[Auto].

2. Select the [Interval]: from 1 minute to 720 minutes.

3. Select the [NIBP] key on the control panel and manually start the first measurement. After the first

measurement, the monitor will automatically and repeatedly start the measurement according to the

interval time set before.

17.3.3.4 Start the Continual Measurement

Select the NIBP parameter area to enter [NIBP Setup]→ [Continual Measure], then start the 5min
measurement continuously.

Note
 If you have any doubt about the reading accuracy, check the patient’s vital signs first before
checking the monitor functions. Use the same method for checking the monitor as checking
the patient.
 In order not to injure the patient, the [Continual Measure] mode is not available for the
patient [Neo].
 The automatic measurement results are affected by the temperature, RH and altitude limit.

Warning
 If any liquid splashes onto the monitor or its accessories, especially when it is likely to flow
into the monitor or its tubes, please contact the maintenance department of the hospital.

17-5
NIBP Monitoring

17.3.4 Stop the Measurement

When a measurement is complete, the monitor can automatically deflate and stop the measurement. During
the measurement, you can press the [NIBP] key on the control panel to stop the measurement.

17.4 NIBP Setup

17.4.1 Patient Type

The patient type includes adult, pediatric and neonate. The patient type is the same as the setting of [PAT
Type] in [Patient Info].
1) Select the NIBP parameter area to enter [NIBP Setup] → [Pat Type].

2) Select [ADU], [PED] or [NEO].

17.4.2 Initial Pressure

1) Select the NIBP parameter area to enter [NIBP Setup] → [Initial Pressure].

2) Set an appropriate value for [Initial Pressure].

17.5 NIBP Reset

Select [NIBP] in the parameter area to enter [NIBP Setup] → [Reset]. This function can restore the initial
pressure of the blood pressure pump. If the blood pressure pump works improperly, use this function to check
the blood pressure pump and automatically recover in the event of failures.

17.6 Assistance in Venipuncture

Inflate the NIBP cuff to a pressure approximate to the diastolic pressure to block the vein vessel and assist in
venipuncture.
1) Select the NIBP parameter area to enter [NIBP Setup] → [Other Setup] → [Cuff Pressure] and then

select an appropriate pressure value.

2) Select [Venipuncture Start], then the key change to [Venipuncture Stop].

3) Puncture the vein and take the blood sample.

4) Press the [NIBP] key or the [Venipuncture Stop] key to deflate the cuff. If you fail to do so, the cuff

automatically deflates after a set time.

17-6
NIBP Monitoring

In the venipuncture process, the NIBP parameter area displays the cuff pressure and remaining time of
venipuncture.

17-7
Chapter 18 Temp Monitoring

18.1 Temp Monitoring

The monitor has two Temp measurement channels and uses a TEMP probe to measure the Temp.
Place the Temp probe under the patient’s axilla or on the patient’s anus, depending on the probe type. To
obtain an accurate measurement result, leave the probe in place to measure the Temp for at least 3min.

18.2 Temp Display

The parameter area displays the Temp value and unit of channel [T1] and [T2] and the Temp difference [TD]
between the channels. Select [Temp] in the parameter area to enter [Temp Setup].

Temp Unit

Alarm Limit

TD: Temp Difference

18.3 Safety instructions

Warning
 The work mode of the Temp probe is the direct mode.
 Before the Temp measurement, check if the Temp probe cable is in good condition. Remove the
Temp sensor cable from the Temp probe connector, and the monitor displays the prompt message
[T1 (T2) sensor off] and triggers the alarm sound.
 Handle the Temp probe and cable with caution. When they are not in use, coil them loosely. Tight
coiling may cause mechanical damage to the cable.
 Calibrate the Temp module at least every two years or as required by the hospital’s regulations.
Contact the manufacturer for calibration when necessary.

Note
 Do not reuse any disposable Temp sensor.

18-1
TEMP Monitoring

18.3.1 Temp Measurement

1) Select an appropriate Temp probe type and size.

2) If you are using a disposable Temp probe, connect it to the Temp cable.

3) Connect the Temp probe or Temp cable to the Temp sensor connector of the monitor.

4) Securely apply the Temp sensor to the patient.

5) Set an appropriate alarm limit.

18-2
Chapter 19 CO2 Monitoring

19.1 Overview

The monitor uses the CO2 measurement to monitor the patient’s respiration status and control patient’s
ventilation. There are two methods of measuring the CO2 in the patient’s airway:
 Sidestream measurement method: take sample from the respiratory gas module in the patient’s airway at

a constant flow rate and use the built-in remote CO2module in the measurement system to analyze them.
The measurement principle is IR emission. Use the optical detector to measure the intensity of the infrared
rays penetrating the respiratory system. The intensity depends on the CO2 concentration as some infrared ray
is absorbed by CO2molecules.
The CO2 measurement involves the following parameters (see the figure below):
 CO2 waveform ①

 End-tidal CO2 (EtCO2): the maximum partial pressure ofCO2 at the end of respiration②

 EtCO2 alarm limit ③

 Fraction of inspiratory CO2 (FiCO2): the minimum CO2 value during inspiration ④

 Airway respiration rate (AWRR): the respiration per minute calculated from the CO2 waveform ⑤

 Measurement unit ⑥
④ ⑥

③ ② ⑤
Warning
 Try to avoid collision and vibration of the CO2 module.

Note
 Do not use the monitor in an environment with any flammable anesthetic gas.
 Only the trained professionals familiar with this manual are allowed to operate the monitor.

19-1
CO2 Monitoring

19.2 Measurement Principle and Working Process

The CO2 measurement principle is mainly based on the feature that CO2 can absorb infrared light with a
wavelength of 4.26 um. The measurement method is to send CO2 gas to the measurement chamber. One side
is irradiated with infrared rays, and the other side is measured by a sensor to measure the degree of attenuation
of the received infrared rays. The degree of attenuation is proportional to the CO2 concentration.
The conversion relational expression between CO2 partial pressure and CO2 concentration is:
CO2 partial pressure (mmHg) = CO2 concentration (%) ×Pamp (ambient pressure)
For instance: 5% CO2 at 760mmHg = 38mmHg
5% CO2 at 700mmHg = 35mmHg
The CO2 module uses the Auto run command measurement mode, and the waveform sampling rate is
performed every 31 milliseconds.

19.3 CO2 Module Connection

1) Connect the module cable to the CO2connector of the monitor.

2) Wait for 10s (Masimo) or 2min (Respironics) until the module reaches its working temperature and a

stable thermal state.

3) Connect the cannula, airway adapter or sampling line to the module reliably until you hear a click.

To the monitor

Respironics Sidestream CO2 Connection

19-2
CO2 Monitoring

Connect the sampling tube and


airway adapter to the patient

To the Monitor

CO2 Sensor
Sensor Adapter

Masimo CO2 Connection Diagram for ISA™ Sidestream Analyzer

4) Use the airway adapter for the intubated patient: install the airway adapter onto the proximal end of the
respiration circuit, exactly between the elbow and the Y-shaped line of the ventilator.

5) Use the nasal cannula for the non-intubated patient: Place the nasal or oral-nasal O2 cannula onto the
patient’s face, connect the O2 supply line to the O2 supply system and set the O2 flow as directed.

Warning
 Check the airway adapter before use. Replace the adapter if the airway adapter has any
exterior damage or breakage.
 When the CO2module is not in use, turn it off to extend its service life.

19-3
CO2 Monitoring

19.4 Measurement Steps for Respironics Mainstream and Sidestream

Analyzer

Turn the mode selection switch to monitor mode.


1) Follow the steps in Section 19.3 to connect the CO2module based on the CO2module type.

2) Select [Screen Layout] to display the CO2 waveform and parameter to be monitored (skip this step if the

CO2 waveform and parameter are already displayed on the screen).

3) Set [O2 Compensate] in [CO2 Setup]. Set the appropriate [O2 Compensate] in the [CO2 Setup] menu. In

general, the value of this item is recommended to be set to FiO2 minus 5%.

4) Set [Balance Gas] in [CO2 Setup] to [Room Air], [N2O] or [Helium] (select [Room Air] if there is no

N2O or helium in the room).

5) Set [Altitude] in [CO2 Setup] to 0~5120.6m (default: 0m), depending on the local altitude. When the CO2

value is too high or too low, follow Table 19-1 to select the relevant local altitude (the barometric

pressure changes with the altitude).

Barometric Pressure Conversion Table – EtCO2 Data Based on Altitude


Altitude Barometric Pressure 5% CO2

Feet Meters mmHg EtCO2mmhg

Sea Level (0) Sea Level (0) 760 38

500 152.4 745 37

750 228.6 738 37

1,000 304.8 731 37

1,500 457.2 717 36

2,000 609.6 704 35

2,500 762 690 35

3,000 914.9 677 34

3,500 1066.8 665 33

4,000 1219.2 652 33

4,500 1371.6 640 32

5,000 1524 628 31

5,500 1676.4 616 31

6,000 1828.8 604 30

6,500 1981.2 593 30

19-4
CO2 Monitoring

7,000 2133.6 581 29

7,500 2286 570 29

8,000 2438.4 560 28

8,500 2590.8 549 27

9,000 2743.2 539 27

10,000 3048 518 26

10,500 3200.4 509 25

11,000 3352.8 499 25

11,500 3505.2 490 24

12,000 3657.6 480 24

12,500 3810 471 24

13,000 3962.4 462 23

13,500 4114.8 454 23

14,000 4267.2 445 22

14,500 4419.6 437 22

15,000 4572 428 21

15,500 4724.4 420 21

16,000 4876.8 412 21

16,500 5029.2 405 20

16,800 5120.6 400 20

Table 19-1
Note: It is assumed that the barometric pressure is 760mmHg and the temperature is 0℃ at the sea level.
Calculation of Atmospheric Pressure: it is based at the sea-level and the ambient temperature at 0℃. Then you
can refer to this table.

Warning
 The monitor has no automatic air compensation function. Set the correct altitude before using
the CO2 measurement function for the first time. Incorrect altitude causes incorrect CO2
reading (5% CO2 error per 1,000m altitude difference).

6) Select [Zero] in [CO2 Setup], and the prompt message ―Zeroing, please wait 30s‖ will appear at the lower
right corner of the screen. Do not start the CO2 measurement until such prompt message disappears.

19-5
CO2 Monitoring

19.5 Measurement Steps for Masimo Mainstream and Sidestream Analyzer

19.5.1 Measurement Steps

Follow the steps below to set the monitor for gas analysis purpose:
1) Follow the steps in Section 19.3 to connect the CO2module based on the CO2module type.

2) Connect the Nomoline sampling tube to the input port of the ISA analyzer.

3) Connect the cable of the ISA analyzer to the CO2connector of the monitor.

4) Enter [User Maintain] and activate the CO2 module.

5) Enter the regular screen of the monitor and select [Screen Layout] to display the CO2 waveform and

parameter to be monitored (skip this step if the CO2 waveform and parameter are already displayed on

the screen).

6) Set an appropriate value for [O2 Compensate] and [N2O Compensate].

7) Connect the gas sample outlet to the scavenging system or make the gas flow back to the patient circuit.

8) The green LED indicates that the ISA analyzer is ready for use.

9) Follow the steps in Section 19.5.2 to perform the checks before use.

10) Start the CO2 monitoring if all the checks are normal.

19.5.2 Checks before Use

Perform the following operations before connecting the Nomoline sampling tube to the respiration circuit:
1) Connect the sampling tube to the gas inlet of the ISA CO2 module.

2) Check if the LED remains a steady green (an indication of normal system).

3) Exhale into the sampling tube and check if the monitor displays the effective CO2 waveform and value.

4) Block the sampling tube with a fingertip and wait for 10s.

5) Check if the prompt message ―Sampling line clogged‖ appears and the LED flashes in red.

6) Check the tightness of the patient circuit connected to the sampling tube when appropriate.

Note
 To prevent the condensed water from dropping into the gas sampling tube and blocking it, the
gas sampling tube connection end of the airway adapter should point upwards.

19-6
CO2 Monitoring

Warning
 Securely hang the external CO2 analyzer onto the CO2holder on the back housing of the
monitor so it does not fall and damage.
 Unless HME is used to protect the IRMA sensor, the LED state indicator should face upwards
all the time during IRMA sensor placement.
 Do not pull the cable of the ISA sidestream gas analyzer.
 Do not operate the ISA sidestream Gas Analyzer in the environment beyond the designated
operating temperature.
 Make sure all connections are firm and reliable. Any leakage will result in the inclusion of
ambient air in the patient’s respiratory gas, which leads to a wrong reading.

19.6 CO2 Setup

19.6.1 Work Mode

Follow the steps below to set CO2 work mode after connecting the CO2module to the monitor. Turn off the
CO2module for service life protection purpose once the CO2 measurement is stopped.
1) Select the CO2 parameter area to enter [CO2 Setup] → [Work Mode].

2) Select [Standby] or [Measure].

19.6.2 Pressure Unit

Enter [User Maintain] to set [Press. Unit].

19.6.3 Gas Compensation

1) Select the CO2 parameter area to enter [CO2 Setup].

 Masimo CO2module:

 Select [O2 Compensate] → [High], [Med] or [Low].

 Select [N2O Compensate] → [On] or [Off].

 Respironics CO2module:

 Select [O2 Compensate] → set the O2 compensation value.

19-7
CO2 Monitoring

Warning
 Set [O2 Compensate] and [N2O Compensate] based on the actual conditions, or the
measurement results could differ greatly from the actual values which can cause misdiagnosis.

19.6.4 No Breath Alarm Delay

No breath detection is to detect the longest interval between two adjacent RESPs. When the actual no-breath
time of the patient exceeds the set apnea time, the monitor responds to apnea alarms according to the value of
[No Breath Alm Delay].
To set the [No Breaths Timeout]:
1) Select the CO2 parameter area to enter [CO2 Setup] → [No Breaths Timeout] and set an appropriate

detection time.
To set the [No Breath Alm Delay]:
1) Enter [User Maintain] → [Other Setup].

2) Set [No Breath Alm Delay] to [Off], [10s], [15s], [20s], [25s], [30s], [35s], [40s], [45s], [50s], [55s] or

[1min].
If you select [Off], the alarm delay function is disabled. The monitor responds to no-breath alarms (if any)
immediately.

19.6.5 Altitude

For Masimo CO2module, there is no need to set the altitude.


1) Select the CO2 parameter area to enter [CO2 Setup] → [Altitude Unit].

2) Select the CO2 parameter area to enter [CO2 Setup] → [Altitude].

3) Set an altitude value, and the monitor is automatically set to [Baro. Pressure] (Barometric Pressure)

based on the altitude value.

19.6.6 Balance Gas

Only the Respironics CO2module requires setting the balance gas manually (for Masimo CO2 module, the
balance gas is automatically set).
1) Select the CO2 parameter area to enter [CO2 Setup] → [Balance Gas].

2) Select [Room Air], [N2O] or [Helium].

19-8
CO2 Monitoring

19.6.7 Waveform Scale

If you adjust the scale value, the waveform amplitude changes accordingly.
Select the CO2 waveform area to enter [Waveform Setup] → [Scale].

19.7 Maintenance and Cleaning of Respironics Mainstream and Sidestream

CO2Module

19.7.1 General Cleaning

Dip a cloth in 70% isopropyl alcohol, water solution (bleach) containing 10% sodium hypochlorite,
disinfecting spray cleaner (like Steris Coverage SprayHB), ammonia water or mild soapy water, wash it with
water, wring it and then air dry the washed cloth. Make sure the module’s sight glass is clean air dried before
use.

19.7.2 Disinfection of Reusable Airway Adapter

Autoclave: applicable to the airway adapter for adults only.


ETO: disinfect the airway adapter for 1.5h.
Dip in CidexPlus solvent for 10h.
Dip in Perasafe solvent for 10h.
Low-temperature sterilization cabinet of U.S. Steris System 1®.
Make sure the airway adapter is not damaged in operations or in the cleaning/disinfection process and its sight
glass is dry without any residue before using the disinfected airway adapter.

19.7.3 Disinfection Frequency of Reusable Airway Adapter

The above disinfection methods allow you to reuse the airway adapter for 100 times.

19.7.4 Zeroing

Usually, the CO2moduleis automatically zeroed when necessary. You can zero it manually as you consider it
necessary: select [CO2] in the parameter area to enter [CO2 Setup] and then select [Zero] to zero the
CO2module. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) for 30s in the zeroing process.
The CO2module is zeroed successfully when the prompt message ―Zeroing, please wait 30s‖ disappears.

19-9
CO2 Monitoring

19.8 Masimo Sidestream Module Related Information

19.8.1 Zeroing

In order to eliminate the effect of the baseline drift on measurement results and obtain accurate measurement
results, zero the sensor before using the CO2module to monitor the patient.
Usually, the CO2moduleis automatically zeroed when necessary. You can zero it manually when you consider
it necessary: select [CO2] in the parameter area to enter [CO2 Setup] and then select [Zero] to zero the
CO2module. Keep the patient circuit in the ambient air (21% O2 and 0% CO2) in the zeroing process. The
CO2module is zeroed successfully when the prompt message ―CO2 is zeroing‖ disappears.

19.8.1.1 Zeroing ISA CO2 Module

The ISA CO2Module requires a zero reference level for the CO2 measurement. This zero calibration is here
referred to as ―Zeroing‖.
The ISA sidestream gas Module performs zeroing automatically by switching the gas sampling from the
respiratory circuit to the ambient air. The automatic zeroing is performed every 24 hours and takes less than 3
seconds for ISA CO2 gas module. If ISA sidestream gas Module is equipped with the oxygen sensor, auto-
zeroing will include the calibration of indoor air of the oxygen sensor.

Warning
 Since successful zeroing requires the presence of ambient air in the gas module, ensure that
the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas
module before or during the zeroing.

19.8.2 CO2Module LED

LED indications:
Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady red light Sensor error
Blinking red light Check adapter

19.8.3 Adverse Effects on Performance

1) The following factors are known adverse effects on the specified performance:
 Quantitative effects of RH or condensation;

19-10
CO2 Monitoring

 Quantitative effects of barometric pressure;


 Interfering gas or water vapor; and
 Other interference sources.
2) Gas Measurement Unit
Use volume percentage as the gas concentration unit. The concentration calculation formula is:

Use the cup-making pressure sensor of the ISA gas analyzer to measure the total pressure of the gas mixture.
To convert into any other unit, use the actual barometric pressure sent from the ISA sidestream (IRMA
mainstream).
CO2 (mmHg) = (CO2 Concentration) x (Barometric Pressure from ISA (kPa)) x (750 / 100).
Take 5.0 vol% CO2 @ 101.3kPa as an example: 0.05 x 101.3 x 750 / 100 = 38 (mmHg).
3) Effects of RH
The partial pressure and volume percentage of the CO2, N2O, O2 and anesthetic gas depend on the water vapor
content in the measured gas. Calibrate the O2 measurement, and the displayed value at the ambient
temperature and RH level will be 20.8 vol%, not the actual partial pressure. The 20.8 vol% O2 represents the
actual O2 concentration of the room air (water concentration: 0.7 vol %) (for example, 25°C and 23% RH @
1013hPa). The monitor displays the actual partial pressure at the current RH level when measuring the CO2,
N2O and anesthetic gas (like all gases measured by infrared cell).
In the patient’s alveoli, the water vapor in the respiratory gas is saturated (BTPS) at the body temperature.
Before the acquired respiratory gas in the sampling tube is transferred to the ISA sidestream gas analyzer, its
temperature becomes approximate to the ambient temperature. No water enters the ISA gas analyzer after the
Nomoline sampling tube removes all condensed water. The RH of the acquired gas is approximately 95%.
Use the following formula to calculate the CO2 value at BTPS:

In the above formula:


EtCO2: EtCO2 value [vol%] sent from ISA
Pamb: barometric pressure [kPa] sent from ISA
3.8 : typical partial pressure [kPa] of the water vapor condensed between the patient circuit and ISA
EtCO2 (BTPS) = EtCO2 concentration [vol%] at BTPS
It is assumed that the O2 is calibrated by the room air at 0.7 vol% H2O (RH).

19-11
CO2 Monitoring

19.8.4 Warning Information

19.8.4.1 ISA Sidestream Gas Analyzer Warning Information

Warning
 The ISA sidestream gas analyzer is intended for use by authorized healthcare professionals
only.
 Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.
 Do not lift the ISA gas analyzer by the sampling line as it could disconnect from the ISA,
causing the ISA gas analyzer to fall on the patient.
 Dispose Nomoline Family sampling lines in accordance with local regulations for biohazardous
waste.
 Use only airway T-adapters with the sampling point in the center of the adapter.
 Do only use sample lines intended for anesthetic agents if N2O and/or anesthetic agents are
being used.
 Do not use T-adapter with infants, as this adds 7 ml dead space to the patient circuit.
 Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as this
may clog the bacteria filter.
 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2), ensure
that the ISA is placed in a well ventilated place. Avoid breathing near the ISA sidestream gas
analyzer before or during the zeroing procedure.
 Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 The ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It must
be used in conjunction with other assessments of clinical signs and symptoms.
 Measurements can be affected by mobile and portable RF communications equipment. Make
sure that the ISA sidestream gas analyzer is used in the electromagnetic environment specified
in this manual.
 Replace the sampling line if the sampling line input connector starts flashing red, or the
medical backboard equipment displays a “Check sampling line” message.
 No modification of this equipment is allowed without authorization of the manufacturer. If this
equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe operation.
 The ISA sidestream gas analyzers are not designed for MRI environments.
 During MRI scanning, ISA must be placed outside the MRI suite.
 Use of high frequency electrosurgical equipment in the vicinity of the ISA/medical backboard
equipment may produce interference and cause incorrect measurements.

Caution
 The ISA analyzers should be securely mounted in order to avoid the risk of damage to the ISA.
 Do not operate the ISA sidestream gas analyzer outside the specified operating environment.
 (US Only) Caution: Federal law restricts this equipment to sale by or on the order of a
physician.
 For professional use. See instructions for use for full prescribing information, including
indications, contraindications, warnings, precautions and adverse events.

19-12
CO2 Monitoring

19.8.5 Airway Obstruction

When the anesthetic gas airway is obstructed, on the screen there will be such a prompt message as ―Sampling
Line Clogged‖; under such a circumstance, replace the Nomoline sampling line.

Warning
 Do not use the ISA gas analyzer together with a quantitative spraying agent or pulverization
treatment; otherwise it may result in the clogging of the germ filter.

19.8.6 Discharging Waste Gases

When nitrous oxide and/or an anesthetic gas are/is used, you should prevent these gases from polluting the
operating room. The gas discharging outlet should be connected to (via the gas discharging pipe connected to
the sample gas outlet of the host equipment):
A discharging system (used for discharging collected gases) or the patient circuit (used for the back flowing of
collected gases)

Warning
 Anesthetics: If you measure the parameter of a patient who is using or recently has usedan
anesthetic, the gas discharging port on the module must be connected to a scavenging system or
the patient circuit (on the anesthesia machine or the ventilator), so as to prevent medical
personnel from inhaling the anesthetic.

19.8.7 Leakage Check

1. Connect a new Nomoline sampling line with male Luer lock to the ISA gas inlet connector and check
that the gas inlet connector shows a steady green light.
2. Connect a short silicon tubing with an inner diameter of 3/32‖ (2.4 mm) to the Nomoline male Luer.
3. Exhale a long breath into the silicon tubing until the CO2 concentration is greater than 4.5 vol% or 34
mmHg.
4. Quickly connect the silicon tubing tightly to the exhaust port.
5. Wait for 1 minute until the CO2 concentration has stabilized. Note the value.
6. Wait 1 minute and check that the CO2 concentration has not decreased more than 0.4 vol% or 3 mmHg.
If it has decreased more there is a major leakage in the ISA unit or in the Nomoline. Do not operate the
ISA if there is a major leakage in the unit.

19.8.8 Safety Symbols

Text, Color Code and Text


Symbol Description
Format
―Warning‖ indicates the hazardous conditions causing
Warning: additional
possible personal injuries or death. The warning
information. symbol should comply with ISO 7010-W001.

19-13
CO2 Monitoring

User’s Manual Refer to the User’s Manual.

Reference No. /

Serial No. /

Lot No. /
Valid until [YYYY-MM-
Do not use the monitor after such date.
DD]

Temperature limit /

Pressure limit /

RH limit /

No reuse /
Recycle this electrical and electronic equipment
WEEE directive
according to 2002/96/EC.

Contain Pb /

The IP grade indicates the water ingress protection


IP grade
performance.
IP grade against water and Protection against tools and short cable ends (>1mm).
solid object ingress Protection against water sprays from all directions.
Warning (U.S.): the monitor shall be sold by medical
Sold on prescription only practitioners or on prescription according to U.S.
federal laws.

CO2 The ISA analyzer measures CO2 only.

Multiple gases (AX+ or


The ISA analyzer can measure multiple gases.
OR+)

Gas inlet /

Gas (exhaust) outlet /

Illustrate the connection between Nomoline and


Connect to patient circuit
patient circuit.

Connect to ISA Illustrate the connection between Nomoline and ISA.

Not sterile, latex free The monitor is latex free and not sterile.

19-14
CO2 Monitoring

19.8.9 Patents and Trademarks

(1) Patent Statement


Masimo Sweden AB owns the following patents for relevant products described in this operating
instruction manual: SE519766; SE519779; SE523461; SE524086. Other patents are being applied.
(2) Trademark
Masimo IRMA™, Masimo ISA™, Masimo XTP™, Sigma Multigas Technology™, LEGI™,
Nomoline™, IRMA EZ Integrator™, MasimoGasMaster™ and ISA MaintenanceMaster™ are
trademarks of Masimo Sweden AB.

19.8.10 Consumables

19.8.10.1 ISA Nomoline Family

ISA samples gas from the respiratory circuit through the Nomoline Family sampling line at a rate of 50
sml/min, making measurements of CO2 possible for adult, pediatric and infant patients.
The Nomoline Family sampling lines incorporate a unique water separation (NO MOisture) section, which
can remove the condensed water. The NOMO section is also fitted with a bacteria filter that protects the gas
analyzer from water intrusion and cross contamination.
As long as no sampling line is connected, the ISA gas analyzer remains in a low-power sleep mode. Once the
sampling line is connected, the ISA gas analyzer switches to measuring mode and starts delivering gas data.
The Nomoline Family sampling lines are available in a wide variety of versions for both intubated and
spontaneously breathing patients and in both disposable and reusable configurations.For instance, the
disposable Nomoline Airway adapter Set or a combination of the reusable Nomoline Adapter and a disposable
Nomoline Extension / T-adapter, is available for the intubated patient. For spontaneously breathing patients,
similarly a disposable Nomoline Nasal CO2 Cannula or a combination of the reusable Nomoline Adapter and
a disposable Nomoline Nasal CO2 Cannula (with Luer Connector) can be applied.

OR

The disposable Nomoline Airway Adapter Set is an alternative to the combination of the reusable Nomoline
Adapter and a disposable Nomoline Extension / T-adapter.

19-15
CO2 Monitoring

The Nomoline Adapter may be used with other third party sampling lines and cannulas. However, note that
the Nomoline Family sampling lines are designed for optimal performance and measurement fidelity when
used with the ISA gas analyzers. For instance, when connecting to a respiratory circuit, the Masimo T-adapter
provides a central gas sampling point thereby minimizing the risk of sampling line occlusion (see below)

For optimal water handling, always use T-adapters with the sampling point in the center of the adapter, as
shown to the left above.

Note
 Using sample tubes or cannulas with larger inner diameter than 1 mm will increase the response
time of ISA system.

Nomoline Family sampling line replacement


Nomoline Family sampling lines should be replaced according to good clinical practice or when the sampling
line gets occluded. Occlusion occurs when water, secretion etc. is aspired from the respiratory circuit to such
extent that ISA cannot maintain the normal 50 sml/min sample flow. This situation is indicated by a red
flashing gas of inlet connector and an alarm message ―Sampling Line Clogged‖; Replace the Nomoline and
wait until the gas inlet connector switches to green indicating that the ISA gas analyzer is ready for use.

19.8.11 Maintenance

The user should verify gas readings regularly; If any problem, contact an engineer of the manufacturer for
maintenance.

19.8.12 Cleaning the Analyzer

The ―Plug in and measure‖ ISA sidestream gas analyzer should be cleaned regularly. Use ethanol or isopropyl
alcohol with a maximum concentration of 70% and a wet cloth to clean the analyzer..
In order to prevent the cleaning liquid and dust from entering into the ISA gas analyzer through the LEGI
connector, the Nomoline sampling line should be connected all the time during analyzer cleaning.

Warning
 The Nomoline sampling line is not a sterile equipment. In order to prevent the sampling line
from causing damages, do not carry out high-pressure sterilization on any part of the sampling
line.
 Do not sterilize the ISA sidestream gas analyzer and the IRMA probe or soak them into a
liquid.

19-16
Chapter 20 IBP Monitoring

Note
 The function is only applicable to S8.

20.1 Overview

The monitor measures the artery pressure (systolic pressure, diastolic pressure and mean pressure).

20.2 Precautions on IBP Monitoring

Warning
 Use the pressure sensor specified herein only.
 Only use the accessories compliant with the safety requirements on medical equipment. Please
refer to the attached user manual for the sterilization identification.
 Do not touch the metal parts connected to electrical equipment when connecting or using any
accessory.
 When the monitor is connected to the highfrequency electrosurgicalequipment, to protect
patient from burns (resulted from electric leakage), do not allow the sensors and cables of
monitor to contacthigh-frequency electrosurgical equipment.
 Never reuse the disposable pressure sensor.
 Before monitoring the patient, check if the sensor cable works properly. Remove the IBP sensor
cable from the sensor connector, and the Monitor displays the prompt message [IBP sensor off]
and triggers the alarm sound.
 If any liquid other than the solution used for the perfusion pressure tube and sensor splashes
onto the monitor or its accessories, especially when it is likely to flow into the monitor or its
sensors, please contact the maintenance department of the hospital.
 If any signs of damage or aging are found on the sensor, cable, and pressure tube, replace the
sensor, cable, or pressure tube immediately prior to use.

20-1
IBP Monitoring

With the protection against electric shock and against the effects of defibrillators, the pressure sensor specified
herein can be used for surgical operations. The pressure waves may become disordered in the defibrillation
process. Once the defibrillation is complete, the monitor returns to normal within 10s and user configurations
remaining unaffected.

Note
 Calibrate the sensor, whether new or used, regularly according to the relevant procedures of
the hospital.

20.3 Monitoring Steps

Preparations for measurement:

1) Prepare the pressure tube and sensor by filling the system with the physiological saline solution. Make

sure there is no bubble in the system.

2) Connect the patient catheter to the pressure tube. Make sure there is no air in the catheter, pressure tube

or sensor.

3) Plug the power cable into the relevant socket and check if the monitor is powered on.

4) Enter [User Maintain] and activate the IBP sensor.

5) Enter the normal screen of the Monitor and select [Screen Layout] to display the IBP waveform and

parameter to be monitored (skip this step if the IBP waveform and parameter are already displayed on the

screen).

6) Place the sensor at the same level as the heart (approximately at the mid-axillary line).

7) Zero the sensor. After the zeroing is successful, close the end of the sensor to atmosphere and open the

end to patient.

Warning
 If there is any bubble in the pressure tube or sensor, use the infusion solution to flush the
system. Bubbles lead to inaccurate measurement.
 To perform the ICP measurement to a sitting patient, adjust the sensor to the same level as the
patient’s ears. Incorrect sensor position leads to inaccurate measurement.

20-2
IBP Monitoring

Anticoagulant
Saline Pressure
Sensor
Valve Three-way
Cock
Pressure Sensor
Dropping Pipette
Interface Cable

Monitor

20.3.1 Zero the Pressure Sensor

Note
 Zero the sensor before monitor the patient. In the IBP monitoring process, keep the pressure
sensor at the same level as the patient’s heart. To avoid catheter clogging, continuously flush
the catheter with the heparin saline to keep the pressure measurement path unobstructed.
Secure the catheter reliably against displacement and disconnection.

To prevent inaccurate measurement, zero the sensor every day or as required by the relevant regulations of the
hospital.
Zero the sensor in the following conditions:
 When using a new pressure tube or sensor;

 When connecting the sensor to the monitor;

 If you doubt the accuracy of the measurement results.


To zero the sensor;
1) Close the valve of the three-way cock to patient.

2) The sensor must be open to the atmosphere first.

3) Select the IBP parameter area (any displayed channel) to enter [IBP Setup] and select [Zero] (the zeroing

result is displayed when the zeroing operation is complete). You can also select [IBP Zero] (quick key) in

the lower menu bar to zero the sensor.

4) Once the sensor zeroing is successful, close its end to atmosphere and open its end to patient.

20-3
IBP Monitoring

20.4 IBP Setup

[IBPx: XXX]: ―x‖ refers to the IBP channel and ―XXX‖ refers to the current pressure name of such channel.

20.4.1 Pressure Name

Enter [Screen Config] to change the pressure name (select an appropriate pressure name from the table below).
Pressure Name Description

ART Arterial pressure

PA Pulmonary artery pressure

CVP Central venous pressure

RAP Right atrial pressure

LAP Left atrial pressure

ICP Intracranial pressure

P1/P2 Expansion pressure

LV Left ventricular pressure

Ao Aortic pressure

UAP Umbilical artery pressure

BAP Brachial artery pressure

FAP Femoral artery pressure

UVP Umbilical venous pressure

IAP Intra-abdominal pressure

P3/P4 Expansion pressure

20.4.2 IBP Overlapping

Two channels of waveforms can be displayed in the IBP waveform area. To enable this function, follow the
steps below:
1) Enter [Main Menu] → [Screen Config] → [Screen Layout].

2) Select IBP waveform and then select the two IBP parameters in monitoring.

20.4.3 Filter Mode

1) The two channels of the module use the same filter mode. Select the waveform of either channel to enter

20-4
IBP Monitoring

[IBPx: XXX Wave] and then set [Filter Mode] to [No Filter], [Smooth] or [Normal].

 No Filter: display the original waveform without filtering it.

 Smooth: obtain a smooth waveform.

 Normal: obtain a relatively smooth waveform.

20.4.4 Pressure Scale

You can adjust the waveform position on the screen by adjusting the upper scale and lower scale. The IBP
waveform area provides the waveform scale. The top and bottom of each IBP waveform represent the upper
scale and lower scale respectively. You can set the upper scale and lower scale. The middle scale depends on
the upper scale and lower scale and it is not selectable.
1) Select [IBPx: XXX] in the waveform area to enter [IBPx: XXX Wave]. Select an appropriate range for

[Upper Scale] and [Lower Scale] respectively.

2) You can set the scale range for the pressure on both channels:

 Upper Scale: the pressure value corresponding to the upper scale limit (selectable range: the

measurement range of the current pressure).

 Lower Scale: the pressure value corresponding to the lower scale limit (selectable range: the

measurement range of the current pressure).

 Middle Scale: the pressure value corresponding to the middle scale limit (selectable range: depend on the

range selected for [Upper Scale] and [Lower Scale]).

20.5 Pressure Unit

1. Enter [User Maintain] → [Unit Setup].

2. Set [Press. Unit] and [cvp Unit].

20.6 Turn on SPV and PPV Display

Select [IBPx:] in the parameter area to enter [IBPx: XXX Setup]. Select [SPV Display] to switch to [ON],
then the SPV and PPV measured values are displayed in parameter area.

20-5
Chapter 21 Data Review

Select the [Review] soft key, or select [Main Menu] and then select [Review] to enter the review screen.
Data Review includes: NIBP Review, Alarm Event Review, Trend Graph Review, Trend Table Review,
Wave Review, 12-lead Report Review, and Patient Event Review.
The monitor provides 120h trend data, 2,000 sets of NIBP measurement data, 200 times of storage of
parameter alarm events, and at most 120h wave review of single-channel wave, up to 5 case ECG reports for
each patient, 1,000 patient events, and up to 60 minutes of AED recording storage for each patient. This
chapter introduces the method to view these saved data in detail.

21.1 Wave Save

You can select the wave to be saved according to the requirements. Only waves set to be saved can be viewed
in [Wave Review]. After admitting a patient, it will be impossible to modify [Wave Save] selection.
1) Enter [User Maintain] → [Wave Save].

2) Select the wave to be saved, and select [Enter]; operate according to the prompt message.
[Rec. Merge]: When admitting a new patient, the monitor creates a patient file, and save current
monitoring data to the patient file created.
[Rec. Not Merge]: When admitting a new patient, the monitor creates a patient file, but current
monitoring data is not saved to the patient file created.

21.2 Trend Review

Trend is a set of patient data over time shown in the form of graph or table.
In the [Trend Review] window, select [Trend Graph] or [Trend Table] to review the corresponding data.
The trend graph continuously shows the updated data. The bottom of the screen shows the time scale.
You can select the desired wave in the parameter area on the left side of the window; besides, you can browse
the trend database using a cursor crossing all measurement items in the window. When moving the cursor, the
current parameter trend data and specific time of data are shown on the right side of the corresponding
window:

21-1
Data Review

Cursor

Parameter Area Data Area

Aperiodic measurements can be viewed from the trend table. This table shows measurement data and
measurement time. During a maximum period of 120h, the trend table data can be viewed.

 Symbol Description

Symbol Introduction
Scroll the page up and down to view other parameter trend graphs not shown in the
current view.
Move the cursor left or right by one step to view along the timeline of trend database.
Move the cursor left or right by one page to view along the timeline of trend database.

Jump to the starting point or the end point of the trend database to view the farthest
(earliest) or nearest (latest) trend info saved.
 Select the date field beside [Start Time], and the setup window will pop up, where you can set the start

time of trend graph review.

 Trend Interval refers to the resolution of trend data shown on the screen. For neonate monitoring, since

21-2
Data Review

the clinical condition of the patient changes fast, a high resolution can be selected; for adult monitoring,

since the clinical condition of the patient changes relatively slowly, a low resolution can be selected.
Set [Res.] (Resolution)
1) In the [Trend Graph]review window

 Select [1s] or [5s] to view the short trend during the past 1h.

 Select [10s] to view the medium trend during the past 4h.

 Select [1 Min], [5 Min] or [10 Min] to view the long trend during the past 160h.

2) In the [Trend Table] review window

 Select [1 Min], [5 Min], [10 Min], [30 Min], [60 Min], [120 Min] or [180 Min] to view the trend

during the past 160h.

 In the [Trend Table] menu, select to enter the [Trend Table Review Report] menu. You can set the

following in this menu:

 Record time: Determine which period of trend data is to be output via [Start Time] and [Forward

Time]. For example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the

trend data to be output are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward

Time] is set to [Auto], trend table data within 30min will be printed. When [Forward Time] is set to

[All], all of the trend table data will be printed.

 [Res.]: Select the resolution for trend table output.

 [Param.] (Parameter Selection): Select the specific parameter to be output in this menu.

 [Record]: After setting, select [Record] to start data output.


Note: Trend graph has no recording setup.

21.3 NIBP Measurement Review

This monitor displays the latest 2,000 sets of NIBP measurement data in [NIBP Review]. In the [Review]
menu, select [NIBP Review], as shown in the figure below:

21-3
Data Review

 Select to enter the [NIBP List Report] menu.

 Record time: Determine which period of trend data is to be output by [Start Time] and [Forward

Time]. For example: If [Start Time] is set to 2015-4-21 10:00:00 and [Forward Time] to [2h], the

trend data to be output are those during 2015-4-21 08:00:00~2015-4-21 10:00:00. When [Forward

Time] is set to [Auto], NIBP list data during 1h will be recorded. When [Forward Time] is set to

[All], all of NIBP list data will be recorded.

 [Record]: After setting, select [Record] to start data output.

21.4 Alarm Event Review

Warning
 Only current physiological and technical information is displayed. Once the monitor is restarted,
all the alarm information is cleared.
 Alarm information in this window is not classified by patient.
 When the alarm event storage reaches the maximum, the oldest alarm events are deleted.

The monitor can display the latest 200 parameter alarm events in [Alarm Event Review], including 200 times
physiological alarm events (including arrhythmia alarm events, and manual events). When an alarm event
occurs, the monitor saves the values of relevant parameters and the waveforms 8s before and after such
occurrence. There are three ways to enter the physiological alarm event review window, as described below:
1) Select the physiological alarm information area;

2) Or in the monitoring mode, press the [Review] soft key, select [Alarm Event Review] → [View

Physiology Alarm];

21-4
Data Review

3) Or enter the [Main Menu], select the [Review] menu, and then select [Alarm Event Review] → [View

Physiology Alarm];
See the figure below:

 You can set the start time of review in [Start Time].

 In [Event] under Alarm Review, you can select the alarm information of the parameter to be viewed.

 Select to directly print current page alarm event data with recorder.
Select [View Technical Alarm] → [View Technical Alarm] menu. See the figure below:

Note
 Technical alarm can only be viewed and cannot be printed.

21-5
Data Review

21.5 Full-Disclosure Wave Review

You can review full-disclosure waves only after the SD card is installed and waveform is set to be saved. The
monitor displays single-channel wave playback for a maximum of 120h in the [Wave Review] window. You
can review the waveform of any parameter of functions configured on the monitor:

Symbol Introduction

Scroll up or down on the page

Waveform gain; select this button to choose the appropriate gain

Waveform currently reviewed; select the waveform to be viewed.

Start time of waveform view.

Record full-disclosure waveform.

 Operation Examples
ECG Wave Review:
1) Before admitting a patient, enter the [Wave Save] window under [User Maintain]; select the waveform to

be saved.

2) In the [Review] menu, select [Wave Review].

3) In the [Wave Review] window, select the parameter to be reviewed.

4) In the [Wave Review] window, you can use to view changes in trend graph time and trend curve.

5) Select to enter the [Wave Review Report] menu. After setting the recorded start time in this menu,
select [Record] to record full-disclosure waveform for 6s.

21-6
Data Review

6) Press to exit the [Wave Review] window.

21.6 12-lead Report Review

The 12-lead report review makes it easy to view all 12-lead ECG diagnostic reports, with up to 5 ECG
diagnostic reports per patient. There are two ways to enter the 12-lead report review window:
1) Press the [Review] soft key and select [12-lead Report Review];

2) Or go to [Main Menu], select the [Review] menu, and then select [12-lead Report Review].
Go to the 12-lead report review window, as shown in the figure below:

In the 12-lead report review, the diagnostic results are arranged in chronological order and a description of the
diagnostic results is listed. If you want to view more detailed diagnostic information, select a diagnosis result
and press the shuttle to view the corresponding diagnosis report, as shown in the figure below:

In the diagnosis report window, you can do the following:

21-7
Data Review

 Select [Diag Wave] to view the 10-second ECG waveform acquired in this diagnosis report.

 Recording the 12-lead report:

1) Go to [Main Menu] → [Config Manage] and enter the access code.

2) Select [12-Lead Setup] → [Report Format] and select [4×3] or [3×4].

3) Select [Record] under this interface to record the output diagnosis report.

21.7 Patient Event Review

The user enters the [Patient Event Review] interface to view 1,000 operation records, as shown in the figure
below:

Select record icon to print all events on the current page.

21-8
Chapter 22 Recording

22.1 Description of Recorder

The monitor uses a thermal array order which supports several recording types and outputs the patient’s
information, measured data, reviews and at most 4 waves.

Recorder key Power indicator


Fault indicator

Recorder door
Latch lock

Attention
 The four channels that record the waveform cannot select the same waveform at the same time.

22.2 Recording Types

Recordings are categorized into the following types according to the ways in which they are triggered:
 Real-time recording triggered manually

 Timed recording automatically triggered by the recorder at the set interval

 Alarm recording triggered by parameter exceeding alarm limit, etc.


Recordings related to specific functions
 Waveform Freeze

 Events: such as charging event, discharge event, marking event, 12-lead report, and automatic inspection

report

 Review data

22-1
Recording

22.3 Recorder Operation

 Start recording manually:

 To start real-time recording, select on the front panel of the monitor.

 To start recordings related to specific functions, select the [Record] button in the current menu or

window.

 Stop recording manually:

 Select on the front panel of the monitor or the [Record] quick key.

 The recorder starts recording automatically in the following situations:

 If the timed recording function is enabled, the recorder starts recording automatically at the set

interval.

 When [Alarm On/Off] and [Alarm Record] of a parameter are both set to [On]; as soon as an alarm

is generated for this parameter, the monitor starts alarm recording.

 The recorder stops recording automatically in the following situations:

 The recording task is fulfilled

 The recorder is out of paper

 The recorder is not operating property.

22.4 Recorder Setup

Open [Main Menu], and select [Record Setup] to enter relevant screen.

22.4.1 Recording waves Setup

The recorder can print 4 waves at one time. In the recording output setup window, set Record Waves 1, 2, 3
and 4. These settings apply to real-time record and timed record.

22.4.2 Paper Speed Setup

1) Enter [Record Setup], select [Paper Speed].

2) Select a value.

22-2
Recording

22.4.3 Real-time Recording

1) In this menu, select [Rt Record Time] (Real-time Record Interval): select a value as needed.
If [8s] is selected, waves for 8s after the current moment are recorded.
If [Continual] is selected, waves after the current moment are recorded; to stop the recording, use the
manual operation.

22.4.4 Timed recording Setup

You can set the recording interval as needed; the setting of real-time record determines the time length
between two adjacent recordings.
1) In this menu, select [Timed Record Interval].

2) Select the interval: [Off], [1h], [2h], [3h] and [4h].

22.4.5 Grid

Select [Grid] and switch it between On and Off. When set it to On, the grid is printed out by the recorder on
the paper; when set to Off, the grid is not printed out on the paper.

22.5 Load Recorder Paper

Load the recorder paper to the thermal recorder (optional) on the right side of the monitor according to the
steps shown in the right figure below:
1) Use the latch lock at the top of the recorder door to open the door.

2) Remove the empty paper core.

3) Load new roll paper and fix it onto the paper clip.

4) The roll feeds paper from the bottom; paper runs across the top of the recorder door.

5) At least one inch of paper should extend out of the edge of the door.

6) Push the recorder door up to close it tightly.

7) To check whether paper is properly loaded, start a recording.

8) If printing is not performed, it indicates the paper may be loaded

inversely. Try reloading the paper.

Load Record Paper

22-3
Recording

Caution
 Load the paper carefully; otherwise the thermal print head may be damaged.
 When the recorder is printing, do not pull the record paper with force; otherwise the recorder
may be damaged.
 Do not keep the recorder door open except for paper change or troubleshooting.
 Use only the recording paper provided by the company.

22.6 Clear Jammed Paper

If the recorder makes any abnormal sound during running or the record paper outputs abnormally, check if
there is a paper jam. If yes, clear the jam according to the following steps:
1) Open the recorder door.

2) Take out the paper, and cut off the folded part.

3) Reload the paper, and close the recorder door.

22.7 Recorder Cleaning

After a long-term use of the recorder, scraps of paper and impurities could accumulate on the print head,
which affects the quality of recording and the service life of print head and roll shaft.
Cleaning procedures:
1) Before cleaning the recorder, prevent the equipment from being damaged by static electricity.

2) Open the recorder door; take out the paper, and use a cotton ball to dip an appropriate amount of alcohol.

3) Gently wipe the surface of the thermal part of print head.

4) When the alcohol becomes completely dry, reload the paper and close the recorder door.

Note
 Do not use any materials (such as abrasive paper), that can damage the thermal part.
 Do not squeeze the thermal print head with force.

22-4
Chapter 23 Other Functions

23.1 Connection to Central Monitoring System

Wired connection:
1) Enter [User Maintain] → [Net Protocol] (Network Protocol).

2) Go to [Main Menu] → [Config Manage] → [Network Setup]

3) Set [Net Bed] (Network Bed Number), [IP Address], [Gateway], [Server IP] and [Server Port]. Normally,

you only need to set Net Bed and leave other options to the default settings.

 [Net Bed] is an identification number used by the monitor to communicate with the central

monitoring system. Its valid range is 1~254.


When the connection is successful, the message prompt area at the bottom of the interface prompts [CMS
Connected].

Note
 Network bed number must be unique in the central monitoring system (CMS).
 For details, see the User’s Instruction Manual for Comen Central Monitoring System.
 After the monitor is connected to the central monitoring system, [Time Settings] turns to gray,
and you cannot make any operations.

23.2 Formatting SD Card

The monitor allows user to format SD card. When [Format SD Card] is selected, all data is removed.
Therefore, this function should be used with caution. During SD card formatting, all operations on the screen
are disabled. When formatting is finished, the monitor restarts automatically.
Steps for formatting SD card:
1) Enter [User Maintain] → [Format SD Card]. A warning dialog [The monitor will auto restart after

formatting SD card! Confirm to format?] displays. Select [Enter] to format the SD card. The monitor

restarts automatically after formatting is finished.

23.3 Analog Output

Enter [User Maintain] → [Analog Out].

23-1
Other Functions

3 leads includes Off, I, and II; 5 leads includes Off, I, II, and V; 12 leads includes Off, I, II, V1, V2, V3, V4,
V5 and V6 (varying with the lead type selected). The monitor can be connected to an oscilloscope or other
external equipment via cables, and outputs analog signals such as lead I or lead II for use by such equipments.

23-2
Chapter 24 Battery

24.1 General Introduction

This monitor is equipped with two lithium rechargeable batteries with number ―1‖ and ―2‖ on the battery icon
to identify. The batteries will be charged automatically once the monitor is connected to the AC power supply,
no matter whether the monitor is turned on or turned off. Under the circumstance of sudden power failure, this
monitor will automatically operate on batteries without any operation interruption. The battery indicator will
turn green after cutting off AC power supply.

Stands for battery 1

Stands for battery 2

When the battery is being charged, the battery bar is moving and the battery indicator turns yellow.
The battery bar displayed on the upper right corner of the screen indicates the battery’s charge level, here
taken battery 1 as an example:

Indicates the battery is full.

Indicates the battery is not full.

Indicates the battery is low and should be charged.

Indicates no battery 1 or damaged battery 1.

There are multiple LEDs on the battery to indicate its approximate battery level. Press the button beside the
LEDs and the LEDs will be illuminated to show the battery level.

Warning

 Check the battery periodically to ensure there is adequate battery power.


 Improper replacement of the lithium battery will result in unacceptable equipment risk.
 Battery electrolyte is hazardous. In case that battery electrolyte comes into contact with your
skin or enters your eyes, wash it with clean water immediately and seek for medical help.
 Keep the battery out of the reach of children.
 When the battery is used for operation, the monitor powers off automatically when the
battery is low.
 Only use the battery specified by the manufacturer.

24-1
Battery

Note
 If the battery is not to be used for a long period of time, please remove the battery and store it
properly according to the manufacturer’s instructions.
 If the monitor is provided with a built-in battery, the battery must be charged after each use to
ensure sufficient charge.
 As the battery is used and aged, the remaining battery power displayed by the battery icon may
deviate from the actual power. Please refer to the system alarm information.

24.2 Battery Alarms

24.2.1 Low Battery Alarms

If battery power is used, when the battery is low, the instrument will report the ―Low Battery‖ alarm. In this
case, the battery shall be replaced or AC power shall be inserted in time to avoid affecting the patient's
treatment and monitoring. When the battery is seriously depleted, the instrument triggers an alarm and shuts
down the countdown. In this case, plug in the AC or replace the battery immediately.

Note
 After the alarm “Low Battery” is triggered, this monitor can at least conduct vital signs
monitoring for 20 minutes and 6 maximum energy deliveries. The battery shall be replaced or
AC power shall be connected immediately.

24.2.2 Battery Aging Alarms

If the operation time of battery is obviously shorter than the time declared in battery specification, the system
will trigger a technical alarm ―Battery 1(2) Aging‖. Under such circumstance, contact the manufacturer to
replace the battery.

24.2.3 Battery Fault Alarms

When there is any battery fault, the system will trigger a technical alarm ―Battery 1(2) Fault‖. Under such
circumstance, replace battery or contact the maintenance personnel.

24-2
Battery

24.3 Battery Installation

1) Turn off the monitor and disconnect power cord and other connecting cables.

2) Put the back panel of the monitor upwards.

3) Align the battery connector with battery pin.

4) Press the battery into the battery pin until it clicks into place.

5) To replace a battery, press the latch on the right end of the battery with right hand and push the battery to

the right with left hand; reinsert a new battery.

Warning
 Only the battery specified by the manufacturer can be used.
 The installation of the battery should be performed by the personnel authorized by the
manufacturer.
 Watch your hand when installing the battery.
 Do not remove the battery when the equipment is working.

24.4 Conditioning and Check Battery Performance

1) Conditioning Battery Performance


If it is the first time to use the battery, ensure that the battery has undergone at least two complete
conditioning cycles. A complete conditioning period means uninterrupted charging till the battery is fully
charged, and then discharging it till the monitor shuts down automatically.
When conditioning the battery, follow these steps:
1) Completely disconnect the monitor from the patient and stop all monitoring and measurement.

2) Put the battery for conditioning in the battery compartment of the equipment.

3) When charging the battery, please ensure that the battery is charged uninterruptedly until it is fully

charged.

4) Disconnect AC power supply, and use the battery to supply power to the monitor until the monitor shuts

down automatically.

5) Battery conditioning is finished.


2) Check Battery Performance
The battery service life varies with the storage and operation environments, frequency of battery discharging
and charging time. The battery performance degrades gradually even if the battery is not used.
Here are the steps for checking the battery:

1) Determine whether the battery is damaged. When the battery icon shows , it indicates the battery

24-3
Battery

is damaged or there is no battery in the battery compartment.

2) Check whether the battery can be charged normally when connected to AC power supply.

3) Completely disconnect the monitor from the patient and stop all monitoring and measurement.

4) When charging the battery, ensure that the battery is charged uninterruptedly for at least 6h till it is fully

charged.

5) Disconnect AC power supply, and use the battery to supply power to the monitor until the monitor shuts

down automatically; meanwhile note down the start time and end time of discharging.

6) The length of discharging time reflects the performance of the battery.

7) When the discharging time reduces to less than 50% of the initial time, replace the battery.

Note
 In order to prolong the service life of the rechargeable battery, if the battery is to be stored for
a long period of time, it is suggested that the battery is charged every three months to prevent
excessive discharging.
 The power supply time of the battery depends on the configuration and operation of the
equipment. For example, frequent NIBP measurement reduces the power supply time of the
battery.

24.5 Battery Recycling

If the battery is obviously damaged or runs out, it should be replaced. Dispose of batteries in accordance with
applicable laws and regulations or the rules of the hospital.

Warning
 Do not disassemble or short-circuit the battery or place it in fire; otherwise the battery may
cause fire, explosion, leakage of hazardous gas or other hazards.

24-4
Chapter 25 Cleaning and Disinfection

Only materials and methods listed in this chapter that are approved by the company can be used for cleaning
or disinfection of the equipment. For any damage arising from use of unaccepted materials or methods, the
warranty does not cover. This chapter describes how to clean and disinfect the monitor and some accessories.
The cleaning and disinfection methods for the remaining accessories are detailed in the corresponding
accompanying documents.
The company does not assume any liability for the effectiveness of listed chemicals or methods when they are
used as infection control means. For infection control methods, consult the Infection Prevention Department
or an epidemiologist in your hospital. Besides, refer to local policies that apply to your hospital and country.

25.1 Overview

Keep the equipment and its accessories dustless. After cleaning, check the equipment carefully. If there is any
evidence of ageing or damage, stop using it immediately. If it is necessary to send the monitor back to Comen
for repair, send us a clean monitor. Observe the following precautions:
 Before cleaning the device, you must turn off the power, remove the battery, and disconnect the power

cord from the outlet.

 Dilute the detergent and disinfectant as specified by the manufacturer, or use a concentration as low as

possible.

 Do not allow any liquid to flow into the housing.

 Do not pour any liquid onto any part or accessory of the equipment.

 Do not soak the equipment in any liquid.

 Do not attempt to sterilize the equipment.

 Use cleaning solutions only as instructed in this operator's manual.

 Do not attempt to clean the equipment while monitoring a patient.

 Do not use any abrasive or corrosive material, bleaching powder or strong solvent (for example, acetone

or detergent containing acetone).

 Keep the electrode paddle clean. The electrode paddle and the electrode base shall be thoroughly cleaned

after each use and before the user detects it.

25-1
Cleaning and Disinfection

Warning
 Only use detergents and disinfectants recommended in this manual. Using other detergents and
disinfectants may result in damage to the equipment or other risks.
 Before cleaning the monitor, power it off and disconnect it from the AC power supply.
 Do not use EtO (ethylene oxide) to disinfect the monitor.
 Do not leave any disinfectant residue on the surface and accessory of the monitor. Use a wet cloth
to clean it immediately.
 It is not allowed to use detergent mixture; otherwise hazardous gases may generate.
 This chapter only introduces the methods for cleaning reusable accessories. Disposable
accessories should not be reused after cleaning and disinfection to avoid cross infection.
 To protect the environment, disposable accessories must be recycled or disposed of properly.
 After cleaning, if the sensor cable is damaged or shows any evidence of ageing, it should be
replaced with a new cable.
 High-temperature sterilization of the monitor and all accessories is not allowed.
 Do not use any cleaning solution not recommended in this manual; failure to do so may result in
permanent damage to the equipment, sensor or cable.
 Do not soak the sensor or connector in any solution for cleaning or disinfection.
 In order to prevent the entry of cleaning solution and dust into the ISA gas analyzer via LEGI
port, the Nomoline sampling line should always be connected when cleaning the ISA analyzer. Do
not soak the ISA sidestream gas analyzer in any liquid for disinfection.
 The Nomoline sampling line is not a sterile equipment. In order to avoid damage, do not sterilize
any part of the sampling line under high pressure.

Caution
 If you carelessly pour any liquid onto the equipment or any accessory, contact the maintenance
personnel or our Company immediately.

25.2 Cleaning of Monitor and Modules

The monitor and modules should be kept clean. It is suggested that the external surface of the housing should
be cleaned frequently; especially in environments with tough conditions or very windy and dusty places, the
cleaning frequency should be increased. Before cleaning, first consult or understand relevant rules of your
hospital on equipment cleaning. Water, hydrogen peroxide (diluted concentration), alcohol (diluted
concentration), isopropanol (diluted concentration), and sodium hypochlorite solution (diluted aqueous
solution) are recommended by our company.
 Cleaning steps:

1) Power the equipment off, and unplug the power cord, accessories and batteries.

25-2
Cleaning and Disinfection

2) Use a soft cloth dipped with an appropriate amount of detergent to wipe the housing of the monitor and

modules.

3) Use a soft cloth dipped with an appropriate amount of detergent to wipe the display screen of the

monitor.

4) If necessary, you can use a soft, dry cloth to remove residual detergent.

5) Put the monitor and modules in a cool, well-ventilated environment to air-dry it.

25.3 Disinfection of Monitor and Modules

It is suggested that the monitor and modules can be disinfected only when it is considered necessary in the
maintenance plan of your hospital. Before disinfection, clean the monitor and modules first. 70% alcohol, 70%
isopropanol, 2% glutaraldehyde, 3% hydrogen peroxide and 0.5% sodium hypochlorite solution are
recommended by our company.

25.4 Cleaning and Disinfection of Accessories

It is suggested that the accessories can be disinfected only when it is considered necessary in the maintenance
plan of your hospital. Before disinfection, clean the accessories first.

Warning
 Do not use a chlorine-containing disinfectant such as sodium hypochlorite solution, bleach, or
chlorhexidine gluconate to wipe the metal parts of the defibrillation electrode paddle. Chlorine
disinfectants and or other oxidizing disinfectants can corrode the electrode paddles.

25.4.1 Cleaning and Disinfection of the External Electrode Paddle

Our recommended external electrode paddle cleaners are: water, alcohol (diluted concentration), and
isopropyl alcohol (diluted concentration); disinfectants are: 70% alcohol, 70% isopropanol, and 2%
glutaraldehyde. Check carefully before cleaning and disinfection. If the external electrode paddle is damaged,
it shall not be used any more.
The specific method is as follows:
1) Soak a soft cloth in a detergent or disinfectant (no water can be squeezed out), and wipe the defibrillation

electrode surface, handle, and cable of the external electrode paddle.

2) If necessary, use a soft, dry cloth to remove excess detergent or disinfectant.

3) If necessary, you can use a soft, dry cloth to remove residual detergent.

25-3
Cleaning and Disinfection

4) Put the paddles in a cool, well-ventilated environment to air-dry it.

5) The two defibrillation electrodes shall be separately wrapped to prevent damage to the electrode surface.

25.4.2 Cleaning and Disinfection of NIBP Cuff

Our recommended NIBP cuff cleaners are: Water, hydrogen peroxide (diluted concentration), alcohol (diluted
concentration), isopropanol (diluted concentration), and sodium hypochlorite solution (diluted aqueous
solution); disinfectants are: 70% alcohol, 70% isopropanol, 2% glutaraldehyde, 3% hydrogen peroxide and
0.5% sodium hypochlorite solution.
Before cleaning the cuff, remove the rubber bag.
The cuff can be washed by machine or hand with warm water and mild detergent. Hand wash can prolong its
service time. The rubber bag can be cleaned using a wet cloth dipped with clean water. Naturally air-dry it
after cleaning.
The cuff can be disinfected using a wet cloth dipped with disinfection. Long-term use of disinfectants may
result in color fading or discoloration of the cuff.

Warning
 Do not squeeze the rubber tube on the cuff.
 During cleaning, only wipe the external surface of the connector. Do not wipe its inner surface.
 Carefully clean the rubber bag. Do not allow any liquid to flow into the rubber bag.
 Do not dry-clean the cuff.
 The disposable cuff can be cleaned with soap to control infection.

After cleaning, put the rubber bag into the cuff according to the following steps:
1) Place the rubber bag on the top of the cuff;
2) Roll the rubber bag lengthwise and insert it into the large opening;
3) Hold the hose and the cuff and shake the complete cuff until the rubber is in position;
4) Thread the hose from inside the cuff and out through the small hole under the internal flap, as shown below:

25-4
Cleaning and Disinfection

25.4.3 Cleaning and Disinfection of Other Accessories

25.4.3.1 Cleaning of Accessories

The cleaning steps are as follows:


1) After using a soft cloth to absorb the proper amount of detergent, wipe the accessories.

2) Wipe off excess detergent with a soft, dry cloth.

3) Place the accessories in a cool and ventilated environment.

The following table lists the recommended detergents.

Cleaning/Disinfection Parts Detergent

Water, hydrogen peroxide, and diluted sodium hypochlorite


Power cord
solution

ECG cable

TEMP probe Water, hydrogen peroxide (diluted concentration), alcohol


(diluted concentration), isopropanol (diluted concentration), and
IBP cable, analog SpO2 main cable,
sodium hypochlorite solution (diluted aqueous solution)
and CO2 extension cable

SpO2 probe

Masimo and Nellcor SpO2 probes and


Water, neutral detergent, and 70% isopropanol
SpO2 cables

Water, alcohol (diluted concentration), and isopropyl alcohol


BP air tube
(diluted concentration)

25.4.3.2 Disinfection of Accessories

The following table lists the recommended disinfectants.

Cleaning/Disinfection Parts Disinfectant

ECG cable
70% alcohol, 70% isopropanol, 2% glutaraldehyde, 3% hydrogen
peroxide and 0.5% sodium hypochlorite solution
TEMP probe

25-5
Cleaning and Disinfection

IBP cable, analog SpO2 main cable,


and CO2 extension cable

SpO2 probe

Masimo and Nellcor SpO2 cables 0.5% sodium hypochlorite solution

BP air tube 70% alcohol, 70% isopropanol, and 2% glutaraldehyde

25-6
Chapter 26 Maintenance

26.1 Maintenance Check

A comprehensive maintenance check including safety check should be conducted by the qualified
maintenance personnel before using, after 6-12 continuous operation or after each maintenance and upgrading.
Check items including:
 Self-test
 Shift exchange check
 User test
 Recorder test
 Manual defibrillation test
 Pacing test
 Functional module test
 NIBP overpressure protection test
 Electrical safety test
Cables and paddles which can be abraded easily are key accessories for this Defibrillator Monitor. Daily
inspection and test is recommended.
If you find any damage on the Defibrillator Monitor, stop using it on patient, and contact the biomedical
engineer of the hospital or our customer service immediately.
All the safety and maintenance checks that need to dismantle the monitor should be performed by a qualified
customer service technician. Non-professional operation can cause the monitor damage or cause a security
risk, and human health may be endangered.
The circuit diagrams of the Defibrillator Monitor can be provided by Comen as per customer demands.
Qualified technicians can use it to help the user repair some apparatus that Comen classifies as ―can be
maintained by the user‖.

Warning
 If the hospital or agency who uses this Defibrillator Monitor does not follow a satisfactory
maintenance schedule, the Defibrillator Monitor may become damaged and personal safety may
be endangered.

26.2 Maintenance and Test Schedule

The following maintenance and test items can only be conducted by the maintenance personnel approved by
Comen. Please clean and disinfect this Defibrillator Monitor before maintenance and test.
Maintenance and test items Schedule
Clean this equipment and accessories After use

26-1
Maintenance

User test (Routinetest, Energy Delivery


Once a week or as required. Controls test is once a year.
test, Controlstest)
Recorder test Once a year or as required

ECG cable test Once a year or as required


Manual defibrillation test (charge and
shock function, disarming energy, Once a year or as required
synchronized defibrillation)
Pacing test Once a year or as required

ECG calibration Once a year or as required


NIBP test (pressure verification, air
Once every two years or as required.
leakage test)
NIBP overpressure protection test Once a year or as required

IBP calibration Once a year or as required

Functional test Once a year or as required

Electrical safety test (Housing leakage


current test, Earth leakage current earth Once every two years, after Defibrillator Monitor falling off
test, Patient leakage current test, Patient and replacing power supply or as required.
auxiliary current test)

26.2.1 Reusable Accessory Service Life

Testing and maintenance items Frequency


ECG lead wire It is recommended to change once every two years.
IBP cabe It is recommended to change once every two years.
Comen SpO2 probe It is recommended to change once every two years.
Nellcor and Masimo SpO2 probe It is recommended to change once every 4380 hours.
Reusable blood pressure cuff It is recommended to change once every 18 months.
Temp probe It is recommended to change once every two years.
CO2 module It is recommended to change once every five years.
External paddle It is recommended to change once every two years.

26.3 Self-test

Each time you turn on the Defibrillator Monitor, it performs internal self-test. If any error is found during self-
test, service indicator will be illuminated and alarm message will be displayed in technical alarm message area.
Self-test contains the following test items:
 Power module test
 Therapy module test
Self-test should be performed every day or after initial installation and replacing components for the main unit
to make sure that the Defibrillator Monitor can work properly.
Specific steps are as follows:
26-2
Maintenance

1. Put paddles into the paddle tray and make them contact well. Install the Defibrillator Monitor with
battery (install two batteries if equipped) and connect AC power supply. Check whether AC indicator and
battery indicator are illuminated.
2. Rotate mode selector to monitor mode. Check whether the Defibrillator Monitor can be turned on.
3. Observe technical alarm message area, physiological message area and battery icon for error message.

26.4 Shift Exchange Check

In order to ensure that your Defibrillator Monitor is available at any time, it is recommended to perform
checks according to the ―Shift Exchange Checklist‖ in Appendix.

26.5 Auto Test

As long as the Defibrillator Monitor is connected to AC power supply, it will perform routine test and energy
delivery test daily at the specified time and remind the users of the error found.
How to set auto test time:
1. Access [Main Menu]→[Config Manage]→enter password
2. Select [Detection Setup]→[Auto Test Time] and select auto test time. Available options include 0:00,
1:00, 2:00, 3:00, 4:00 and 5:00.
Auto test item and schedule are listed below:
Test item Description Schedule
Routine test Test battery and therapy modules Once a day from 0:00 to 5:00
Energy delivery test Deliver 200J energy Once a week after routine test.

There is no prompt message on the screen of Defibrillator Monitor during auto test. If auto test fails, the
maintenance indicator will flash and the buzzer will continue to sound at regular intervals until it is turned
back on. After turning on the Defibrillator Monitor, a low level technical alarm ―Last Auto Test Failed‖ will
be triggered. If the next auto test passes, or the routine test or energy delivery test which fails in auto test
passes during user test, the ―Last Auto Test Failed‖ alarm will be cleared.
It is recommended to perform user test if the auto test fails.
The Defibrillator Monitor will save an auto test report after each auto test. You can choose whether to print
auto test report after each auto test. Specific steps are:
1. Access [Main Menu]→[Config Manage]→enter password.
2. Select [Record Setup]→[Auto Record] →[Auto Check Report] and select [On] or [Off].
You can select [History] in user test interface to view the auto test results.

Attention
 If the Defibrillator Monitor is switched off, it will perform auto test daily at the specified time
only when it is connected to AC power supply.
 Install the Defibrillator Monitor with at least one battery, place the paddles in the paddle tray
correctly or connect electrode cable and 50Ω test load, or the auto test will not pass.
 Clean the paddles and place them into paddle tray correctly after each use. Only when the

26-3
Maintenance

paddles contact well with the metal parts of paddle tray, will the auto test pass.

26.6 User Test

User test performs routine test, energy delivery test and controls test.

Warning
 Make sure that patient is not connected to the Defibrillator Monitor when conducting user test.

Attention
 Install the Defibrillator Monitor with at least one battery, place the paddles in the paddle tray
correctly or connect electrode cable and 50Ω test load, or the auto test will not pass.
 Clean the paddles and place them into paddle tray correctly after each use. Only when the
paddles contact well with the metal parts of paddle tray, will the auto test pass.

26.6.1 User Test Interface

Access [Main Menu]→[User Test] to enter user test interface.

Select items to be tested and select [Start] to start test. Perform the test following what indicated on the screen.
After test, the ―Test completed‖ prompt message will be displayed. Press [Record] to print the test result.
Press [Back] soft button to return to user test interface.

26-4
Maintenance

26.6.2 Routine Test

Routine test includes the following test items:


 Battery 1, battery 2
 Main board
 Power board
 Defibrillation/pacer function
 Monitor function
Perform the test following what indicated on the screen.
If any test item of routine test fails, the service indicator will be illuminated. The test result of each test item
will be displayed on the screen. If the defibrillation/pacer function test fails, the system will give low level
technical alarm ―Last User Test Failed‖ when switching on the Defibrillator Monitor next time and it is
suggested to perform a successful user test to clear this alarm.

Attention
 It is recommended to perform user test when changing shift.

26.6.3 Energy Delivery Test

Energy delivery test includes 200J charge and shock test and charge and shock circuit function test. Perform
the energy delivery test following what indicated on the screen.
If energy delivery test fails, the service indicator will be illuminated and the system will give low level
technical alarm ―Last User Test Failed‖ when switching on the Defibrillator Monitor next time. It is suggested
to perform a successful user test to clear this alarm.

26.6.4 Controls Test

Controls test includes the following test items:


 Controls (all the buttons on front panel and mode selector)
 Audio test
 Display test
Perform the controls test following what indicated on the screen.
If any test item of controls test fails, the service indicator will be illuminated and the system will give low
level technical alarm ―Last User Test Failed‖ when switching on the Defibrillator Monitor next time It is
suggested to perform a successful user test to clear this alarm.

Attention
 During controls test, the controls have been tested turn green.
 Controls test doesn’t test the OFF mode. If you rotate the mode selector to OFF for more than
2s, the Defibrillator Monitor will shut down.

26-5
Maintenance

26.6.5 Test Result Review

The Defibrillator Monitor could save the test results of routine test, energy delivery test and controls test.
Press [History] in user test interface to view the test results.

The Defibrillator Monitor could save up to 300 test reports which are listed in chronological order. Select a
certain test report to view it in detail. Select [Record] to record this test report.
Press [Pre Page] and [Next Page] to view the test reports not on current page. Press [Delete All] to delete all
the test reports. Press [Back] soft button to return to user test interface.

26.6.6 User Test Prompt

It is recommended to perform routine test and energy delivery test once a week and controls test once a year.
Each time you turn on the Defibrillator Monitor, the system will check the time period from last routine test,
energy delivery test and controls test automatically. If user test prompt function is activated and you do not
perform corresponding test within the suggested time period, the system will give technical alarm ―User Test
Due‖. If user test prompt function is deactivated and there will be no prompt even when user test is overdue.
How to activate or deactivate user test prompt function:
1. Access [Main Menu]→[Config Manage]→enter password
2. Select [Detection Setup]→[User Test Prompt] and select [On] or [Off].

26.7 Recorder Test

1. Start the Defibrillator Monitor and switch to monitor mode.


2. Print ECG waveforms. Verify that the recorder can print normally and what printed is clear.
3. Simulate such troubles as no recording paper and recorder door open, and check whether there is
corresponding prompt message on the screen. After clearing all these troubles, check whether the
recorder can work properly.

26-6
Maintenance

26.8 ECG Cable Test

It is recommended to conduct ECG cable test once a year.


Test tool: ECG simulator
Specific test steps are as follows:
1. Switch to monitor mode. If 12-lead ECG cable is being test, enter 12-lead screen.
2. Connect the ECG cable to the Defibrillator Monitor and connect the ECG lead wire to ECG simulator.
3. Start ECG simulator and select a normal ECG rhythm
4. After several seconds, check that there is normal ECG waveform displayed and there is no ―ECG LEAD
OFF‖ technical alarm. For 12-lead ECG cable, press button to print 12-lead real-time waveform and
confirm the output waveforms of all leads are normal.

26.9 Manual Defibrillation Test

Test tool: Defibrillator/Pacer analyzer

26.9.1 Charge/ Shock Function

1. Remove two batteries, connect the Defibrillator Monitor to AC power supply only, switch on the
Defibrillator Monitor and switch to manual defibrillation mode.
2. Connect paddle cable with the therapy cable connector on the Defibrillator Monitor. Place the paddles on
the defibrillator/pacer analyzer correctly.
3. Access [Config Manage]→ [Record Setup]→[Auto Record] and set [Charge Event] and [Shock Enevt]to
[ON].
4. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy is 0 or blank this moment).
5. Select 1J energy for the Defibrillator Monitor.
6. Charge the defibrillator and deliver the energy to verify whether the value measured by the
defibrillator/pacer analyzer meets the accuracy requirements shown in the following table.
Energy select (J) Measured value (J)
1 0~3
100 85~115
360 306~414
7. Adjust energy level to 100J and 360J respectively and repeat step 6.
8. Operate the Defibrillator Monitor on fully charged battery, switch on it and switch to manual
defibrillation mode. Repeat step2 through step 7.
9. Check whether the charge/shock event has been recorded automatically and what has been recorded is
correct.
10. Use the pads and repeat step 3 through step 9.

26.9.2 Disarming Energy

1. Operate the Defibrillator Monitor on fully charged battery, switch it on and switch to manual
26-7
Maintenance

defibrillation mode.
2. Connect paddle cable with the therapy cable connector on Defibrillator Monitor. Place paddles on the
defibrillator/pacer analyzer correctly.
3. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy should be 0 or blank at this moment).
4. Select 360J energy for the Defibrillator Monitor.
5. Charge the Defibrillator Monitor.
6. Check whether there is charge tone during charge.
7. After charge, press [Disarm] soft button to disarm the energy.
8. Check there is ―Charge Removed‖ prompt message and the charge completed prompt tone stops.
9. Check that the measured energy value on defibrillator/pacer analyzer is 0J or blank.
10. Access [Config Manage]→[Manul Def Setup]and set [Auto Disarm Time] to 60s.
11. Exit [CONFIG SETUP] menu.
12. Set the operating mode of defibrillator/pacer analyzer as energy measurement mode (the displayed
energy should be 0 or blank at this moment). Select 360J energy for the Defibrillator Monitor and charge.
13. Form the moment charge completes, check whether there is ―SHOCK CANCELED‖ prompt message
after 60s and whether the measured energy value on defibrillator/pacer analyzer is 0J or blank.
14. Use pads and repeat step3 through step 12.

26.9.3 Synchronized Defibrillation

1. Connect paddle cable with the therapy cable connector on Defibrillator Monitor. Place paddles on the
defibrillator/pacer analyzer correctly. Connect ECG cable with the Defibrillator Monitor and connect the
lead wires to the defibrillator/pacer analyzer.
2. Set the operating mode of defibrillator/pacer analyzer as synchronized defibrillation time measurement
mode and output normal sinus rhythm (for example: amplitude 1mV, heart rate 60bpm).
3. Access [Config Manage]→[Manul Def Setup]and set [Sync Keep] to [On].
4. Select 10J for the Defibrillator Monitor.
5. Press [Enter Sync] soft button to enter synchronized defibrillation mode. If remote synchronization input
function is activated, after pressing [Enter Sync] soft button, select [Local] in the pop-up dialog box to
enter synchronized defibrillation mode.
6. Press LEAD SELECT button on the front panel to select [Pads] as ECG source and charge the
defibrillator.
7. After charge, press both shock buttons on paddles to deliver the energy synchronously.
8. Check whether the system can deliver the energy synchronously. The delivered energy measured by the
defibrillator/pacer analyzer should meet the requirement of 10J±2J.
9. Check that the delay of defibrillation synchronization measured by the defibrillator/pacer analyzer is less
than 60ms.
10. Check that the synchronized shock marker is above R wave.
11. Check that the prompt messages are correct during the test.
12. Select lead II as ECG source. Charge the defibrillator and repeat step 7 through step 11.
13. Use pads and repeat step 2 through step 12.

26-8
Maintenance

26.10 Pacing Test

Test tool: defibrillator/ pacer analyzer


1. Operate the Defibrillator Monitor on fully charged battery, switch it on and switch to pacer mode. Enter
[Config Manage] and set the pacing mode to [Fixed Pace].
2. Connect pads cable to the Defibrillator Monitor and place pads on defibrillator/pacer analyzer correctly.
3. Set the operating mode of defibrillator/pacer analyzer as pacing measurement mode and set test load as
50Ω.
4. Set the [Pace Rate] to [70ppm] and [Pace Ele] to [30mA].
5. Press [Start Pace] soft button. Verify whether the pacing rate measured by the defibrillator/pacer analyzer
meets the requirement of 70 ppm±1ppm and pacing current meets the requirement of 30 mA±5mA.
6. Press [Stop Pace] soft button. Set the [Pace Rate] to [170ppm] and [Pace Ele] to [200mA].
7. Press [Start Pace] soft button. Verify whether the pacing rate measured by the defibrillator/pacer analyzer
meets the requirement of 170 ppm±2ppm and pacing current meets the requirement of 200 mA±10mA.

26.11 ECG Calibration

During the use of monitor, ECG calibration is required when the ECG signal is inaccurate. ECG calibration
should be conducted by the serviceman approved by Comen at least once a year or when you doubt the
measured value.
Specific steps are as follows:
1. Enter [Main Menu]→[Maintain]→[User Maintain]→enter password →[ECG Calibrate].Then the screen
displays square wave signal and displays prompt message ―Cal...can't monitor!‖.
2. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
3. After calibrating, press [Stop ECG Cal].

26.12 NIBP Air Leakage Test

The NIBP Leakage Test is used to detect whether the NIBP measuring pump leaks. When the NIBP cuff is
connected, this button can be used to activate the NIBP inflation process, so as to detect whether the NIBP gas
circuit is in good airtight condition. If the result of gas leakage test is OK, the system does not give any
prompt; if not, a corresponding error message is shown in the NIBP info area.
Gas Leakage Test Process:
1) Properly connect the cuff to the NIBP opening in the monitor.
2) Wrap the cuff around a cylinder of proper size.
3) Enter [Main Menu] →[Maintain]→[User Maintain]→ [Leakage Test].
4) At this moment, [Leakage Testing] is shown in the lower part of the NIBP parameter area on the screen,
indicating that the system started performing the air leakage test.
5) The system inflates the cuff automatically until the pressure reaches 180mmHg.
6) About 20s later, the system turns on the deflation valve automatically, indicating that leakage
measurement is finished.

26-9
Maintenance

If no prompt message is shown in the NIBP parameter area, it indicates the system has no leakage. If
[Pneumatic Leak...] is shown, it indicates the air circuit may leak. At this moment, the operator should check
the complete connection to see if there is any looseness. After confirming the connection is correct, perform
the leakage test again. If there is still any fault prompt, contact the manufacturer for repair.

Cylinder
Monitor
Tube
Cuff

Warning
 This leakage test is different from those described in EN 1060-1. This is simply for the user to
test whether there is air leakage during NIBP inflation. If the system shows NIBP air leakage at
the end of the test, contact Comen’s service technician.

26.13 NIBP Pressure Verification

Warning
 Calibration of NIBP measurement should be performed once every two years (or according to
maintenance rules of your hospital). Check its performance according to the following details.

NIBP pressure verification should be carried out once a year or when you doubt the measured NIBP by the
serviceman approved by Comen.
Manufacturers recommend a calibrated pressure gauge (or mercury sphygmomanometers) with a precision
more than 1mmHg to be used for NIBP pressure verification. Specific steps are as follows:
1. Set measure mode to adult mode and select a metal container with a volume of 500ml ± 5% to replace
cuff.
2. Connect a calibrated standard gauge with measurement error of less than 1mmHg, a spherical air pumps
with a t-interface and inflatable tubes with NIBP socket on the monitor as the figure shown below:

26-10
Maintenance

Monitoring Standard pressure meter


NIBP
Gas pipe

Round pump Metal vessel

3. Access [Main Menu]→[Maintain] →[User Maintain] → [NIBP Verify].


4. The standard pressure gauge shall read zero before inflation. If it is not zero, open the ball pump valve so
that the entire gas circuit leads to the atmosphere, and then close the valve after the standard pressure
gauge reads zero.
5. Inflate the metal container with spherical air pump to pressure of 50 and 200 mmHg respectively. The
difference of pressure value between standard pressure gauge and monitor should be within 3mmHg.
Otherwise, please contact the Comen maintenance engineers.

26.14 NIBP Overpressure Protection Test

It is recommended to conduct NIBP overpressure protection test once a year. The specific steps are as follows:
1. Open the housing of the Defibrillator Monitor, take out the multi-parameter module, remove the gas tube
connected with NIBP measuring transducer and block it up.
2. Connect NIBP cuff.
3. Start NIBP measurement. When the pressure rises to the overpressure protection point (300~
330mmHg), the valve will open and the sound of deflation will be heard, and the prompt message ―Over
Pressure‖ will be displayed on the screen.
If the system can give an alarm and deflate normally, the overpressure protection function is normal.
Otherwise, please contact the service technician of our company.

26.15 IBP Calibration

IBP calibration can only be performed by the manufacturer at least once a year or as required. When IBP
calibration is needed, please contact the manufacturer.

26.16 Electric Safety Test

The users can not conduct the electric safety test including ground impedance test, leakage current test and so
on. Please contact the service technician for the electric safety test when necessary.
26-11
Appendix I Accessories

Warning
 Please use the accessory models specified by the manufacturer. Using other models of
accessories may damage the monitor or affect performance.
 Disposable accessories can only be used once. Repeated use may result in reduced performance
or cross-infection.
 Please check the packaging of the accessories before using the accessories. Do not use the
accessory if it is found to be damaged or not.
 Expired and damaged accessories may cause environmental pollution and must be disposed of
in accordance with relevant local laws and regulations or hospital systems.
 When using accessories, refer to the accessory manual, and consider the requirements for
operating environment of accessories.

Defibrillation accessories
Accessory Patient type Model Part No.
External paddles Adult, pediatric CM3901 040-000660-00
Pads Adult DF20N 040-000665-00
pediatric DF31L 040-000666-00
Pads cable / CM3905 040-000664-00
ECG accessories
Accessory Lead type Compatible Type Model Part No.
with
ECG lead wire 12-lead AHA Clip 98ME01AB076 040-000481-00
12-lead IEC 98ME01EB075 040-000487-00
5-lead AHA 98ME01AC457 040-000480-00
5-lead IEC 98ME01EC680 040-000486-00
3-lead AHA 98ME01AC458 040-000479-00
3-lead IEC 98ME01EC681 040-000485-00
SpO2 accessories
Accessory Patient type Type Model Part No.
SpO2 sensor Adult Reusable, finger DS-100A 040-000010-00
Adult Reusable, finger DURA-Y®D-YS 040-000075-00
Pediatric Reusable, finger OXI-P/I 040-000086-00
Neonate Reusable, foot OXIBAND®OXI-
040-000087-00
Adult Reusable, finger A/N
Pediatric Disposable, finger MAX-P 040-000004-00

I-1
Accessories

Neonate Disposable, foot


OXIMAXMAX-N 040-000223-00
Adult Disposable, finger
Neonate Disposable, foot
M-LNCS NEO-3 040-000200-00
Adult Disposable, finger
Neonate Disposable, foot
M-LNCS NEO 040-000232-00
Adult Disposable, finger
Infant Disposable, foot M-LNCS INF-3 040-000198-00
Pediatric Reusable, finger M-LNCS DCIP 040-000373-00
Neonate Reusable, finger M-LNCS YI 040-000361-00
Adult Reusable, finger M-LNCS DCI 040-000203-00
Pediatric Reusable, finger A1418-SP203PV 040-000034-00
Adult Reusable, finger A0916-SA203MV 040-000646-00
Neonate Reusable, Bundle A1418-SW203MU 040-000334-00
Neonate Reusable, Bundle A0816-SW106PU 040-000715-00
Adult Finger SAL001 040-000726-00
Pediatric Finger SCL001 040-000727-00
Adult Finger SAS001 040-000728-00
Pediatric Finger SCS001 040-000729-00
Neonate Foot SES001 040-000730-00
SpO2 sensor belt / Reusable M-LNCS YI 040-000362-00
NIBP accessories
Accessory Type Model Part No.
NIBP cuff Adult, Reusable U1880S 040-000583-00
Pediatric, Reusable U1881S 040-000584-00
Infant, Reusable U1882S 040-000585-00
Pediatric, Reusable U1883S 040-000586-00
Reusable, adult, thigh U1884S 040-000587-00
Reusable, small adult U1885S 040-000588-00
Reusable, large adult U1869S 040-000589-00
Reusable, small adult, extension U1889S 040-000590-00
Adult, thigh CK-XT-78243-001 040-000091-00
Adult CK-XT-78243-003 040-000092-00
Infant CK-XT-78243-008 040-000120-00
Pediatric CK-XT-78243-007 040-000140-00
Neonate CK-XT-78243-000 040-000141-00
TEMP accessories
Accessory Patient type Application site Model Part No.
Temperature probe Adult Skin surface TAS03-04 040-000246-00

I-2
Accessories

Neonate Skin surface TPS03-03 040-000387-00


/ Rectum TAE03-03 040-000385-00
Neonate Rectum TPE03-04 040-000386-00
Adult 2.25K Skin surface TPS03-07 040-000534-00
Pediatric 2.25K Skin surface TPS03-06 040-000650-00
Adult 2.25K Rectum TAE03-08 046-000652-00
Pediatric/ neonate Rectum TPE03-07 040-000651-00
2.25K
CO2 accessories
Type Accessory Patient type Model Part No.
RESPIRONIC LOFLO™ CO2 / 1022054 099-000004-00
sidestream module
CO2 nasal tube Adult 3468ADU-00 040-000027-00
CO2 nasal tube Infant 3468INF-00 040-000028-00
CO2oral/ nasal tube Adult 3470ADU-00 040-000029-00
CO2oral/ nasal tube Pediatric 3470PED-00 040-000030-00
Airway adapter Pediatric/adult 3473ADU-00
(with dryer line) 040-000024-00
Airway adapter Infant/Neonate 3473INF-00
(with dryer line) 040-000026-00
Airway adapter Adult/pediatric 3472ADU-00
(without dryer line) 040-000316-00
Sampling line (with / 3475-00 040-000399-00
dryer line)
ISA™ CO2 module / CAT.NO.800101 099-000007-00
MASIMOsidestream NOMOLINE / CAT.NO.108210 040-000017-00
sampling line
CO2 module / C300 099-000021-00
T-type airway
/ L 040-000408-00
adapter
Dryer line / ME-050-12ML 040-000405-00
Comensidestream Disposable nasal
/ DM3100 040-000407-00
sampling line
Disposable
extension sampling / MM 040-000406-00
line
IBP accessories
Accessory Type Model Part No.
IBP transducer Disposable PX260 040-000673-00
Disposable 42584-05 040-000674-00
Disposable 5202620 040-000675-00
Disposable DPT-248 040-000633-00

I-3
Accessories

Disposable DT-4812 040-000634-00


Disposable DP-248 040-000013-00

I-4
Appendix II Product Specifications

1) Monitor Type
Item Classification
Type of protection against electrical I class, CF and BF applied parts with defibrillator-
shock proof protection
Type of medical apparatus and IIb class
instruments management
Degree of protection against harmful IPX4
ingress of water
Safety degree of use in the environment This Defibrillator Monitor cannot be used in the
with flammable anesthesia gas or nitrous environment with flammable anesthesia gas or nitrous
oxide (Not applicable) oxide
Operating mode Continuous

2) General Specifications
2.1 Dimension and Weight
Item Specifications
Size and Size:324mm(L)×220mm(W)×345mm(H)(Including external paddles)
weight Size:301mm(L)×220mm(W)×345mm(H)(Not including external paddles)
Weight: 7.5Kg (not including batteries)
Weight of one battery: 0.7Kg

2.2 Environmental Specifications


Item Specifications
Work Environmental 0℃~45℃
environment temperature
Relative humidity Humidity 10%~95%, no condensation
Atmospheric pressure 700hPa~1060hPa
Power Voltage 100V~240V
requirements Frequency 50Hz/60Hz1Hz
Input current 2.0A-1.0A
Transport Avoid severe shock ,vibration, rain and snow during transport
Storage The packaged Defibrillator Monitor should be stored in the room with
environment temperature of -20 ℃ ~ +70 ℃ , with humidity 10%~95%(no
condensation), with good ventilation and without corrosive gas

II-1
Product Specifications

2.3 Display
Item Specifications
Screen size 8.4 inch color TFT display screen
Displayed Up to 5 waveforms can be displayed.
information
Resolution 800×600 pixels

2.4 Recording (optional parts)


Item Specifications
Paper width 80mm
Paper speed 12.5/25/50 mm/s
Real-time recording time 8s,16s,32s
Number of waveform channels Up to four waveform channels
Recording triggered by alarms With this function

2.5 Battery
Item Specifications
Battery Two rechargeable lithium-ion battery 4500mAh, 14.8V
Charge time Charge time to 80% charge level in less than 2 hours; charge time to 100%
charge level in less than 3 hours
Running time Running time of one battery in the environmental temperature of 20℃ is as
follows: (Running time of two batteries is twice of that of one battery)
 Monitoring mode: more than 5 hours(interval of NIBP measurement is 15
minute and no printing);
 Defibrillation mode: more than 100 discharges(maximum energy level,
charge interval more than 1 minute and no printing)
 Pacing mode: more than 2 hours (50Ω load, frequency 80bpm, current
60mA and no printing)
Battery There is multiple LEDs on the battery to indicate its approximate charge
capacity
indicator
Low battery After low battery alarm, 20 minutes vital sign monitoring and at least 6
alarm maximum energy discharges can be conducted at the same time.

2.6 Data storage


Item Specifications
Trend data Short trend 1 hour with resolution of 1 second
Long trend 120 hours with resolution of 1 minute
Trend graph and trend table 120 hours
Alarm events 200 alarm events with relevant parameter values and waveforms
of 32s at alarm moment.
NIBP measurement data 2000
12-lead diagnosis report 5 12-lead diagnosis reports for each patient

II-2
Product Specifications

Taping Store up to 480min taping (up to 60min for each patient)


Parameter waveforms 120 hours

2.7 Defibrillation specification


Item Specifications
Defibrillation mode Manual defibrillation, synchronized defibrillation and AED
Defibrillation waveform BTE waveform. The waveform parameters are compensated
automatically according to patient impedance.
Type of defibrillation External paddles, therapy electrodes; child external paddles are
electrode inside adult external paddles
Controls and indicators of There are charge button, shock button and energy select button on
external paddles external paddles and there is instruction when charge completes.

Energy select
External defibrillation 1/2/3/4/5/6/7/8/9/10/15/20/30/50/70/100/120/150/170/200/220/250/2
70/300/360J
Internal defibrillation 1/2/3/4/5/6/7/8/9/10/15/20/30/50J

Range of patient impedance


External defibrillation 20Ω~250Ω
Internal defibrillation 15Ω~250Ω

Charge time
Powered by new fully Charge time to 200J in less than 5s; charge time to 360J in less than 8s
charged battery(with 20℃
environmental
temperature)
Powered by AC power Charge time to 200J in less than 7s; charge time to 360J in less than
supply 11s

Synchronized discharge delay


Local synchronized Less than 60ms
discharge delay
Remote synchronized Less than 25ms(from synchronized signal rising edge)
discharge delay

AED
Serial shock Shock energy: 100~360J
Shock times: 1, 2,3
Shockable rhythm VF, VT (heart rate >150bpm and QRS width >120ms)

AED algorithm performance


Type of heart rhythm Performance requirements Remark

II-3
Product Specifications

Shockable rhythm-VF Sensitivity>90% Comply with AAMI DF80 and AHA


(sensitivity>90%)
Shockable rhythm- VT Sensitivity >75% Comply with AAMI DF80 and AHA
(sensitivity>75%)
Nonshockable rhythm- Specificity >99% Comply with AAMI DF80 and AHA
NSR (specificity >99%)
Nonshockable rhythm- Specificity >95% Comply with AAMI DF80 and AHA
asystole (specificity >95%)
All other nonshockable Specificity >95% Comply with AAMI DF80 and AHA
rhythms (specificity >95%)

360J defibrillation waveform (load impedance is 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω and 175Ω,
respectively)

175Ω
150Ω
125Ω
100Ω
75Ω
50Ω
25Ω

Energy accuracy
Impedance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω Accur
Energy acy
1J 1 1 1.1 1 100Ω
1 0.9 0.8 2J
2J 2 2 2 2 2 1.8 1.8 2J
25Ω
3J 2.8 3 3 2.8 3 2.7 2.5 2J
4J 3.8 4 4.1 3.8 4 3.6 3.5 2J
5J 4.8 5 5.0 4.8 4 4.5 4.2 2J
6J 5.8 6 5.9 5.9 5 5.4 5.3 2J
7J 6.8 7 6.9 6.9 6.8 6.3 6.0 2J
8J 7.8 8 8 8.0 7.5 7.2 7.0 2J
9J 8.8 9 9 8.6 8.5 8.1 7.7 2J
10J 9.6 10 9.9 9.6 9.3 9.0 8.4 2J
15J 15 15 15 14 14 13 13 15%
20J 19 20 20 19 18 17 17 15%
30J 29 30 30 29 27 26 25 15%

II-4
Product Specifications

50J 49 50 49 48 45 44 42 15%
70J 68 70 69 66 63 60 58 15%
100J 98 101 98 95 90 86 83 15%
120J 118 122 119 114 109 104 100 15%
150J 148 152 148 142 136 130 124 15%
170J 167 172 168 160 151 147 140 15%
200J 197 203 198 189 180 173 165 15%
220J 217 224 218 209 199 190 182 15%
250J 245 254 247 237 226 216 207 15%
270J 267 275 267 256 244 233 223 15%
300J 297 305 296 284 270 258 247 15%
360J 356 363 354 339 324 310 296 15%

2.8 Pacing Specification


Pacing
Pacing mode Fixed pacing and demand pacing
Pacing waveform One-way square-wave pulse with pulse with of 20ms±1.5ms
Pacing rate 40ppm~170ppm with accuracy of ±1.5%
Pacing current 0mA~200mA with accuracy of ±5% or 5mA (larger one)
Pacing with decreased When this function is enabled, pacing rate decreased to 1/4 of original
speed rate.
Output protection The output end of S8/S6 Defibrillator Monitor can stand 360J discharge
without any damage.

2.9 ECG Specifications


Item Specifications
ECG input Support ECG detected through 3-lead ECG cable, 5-lead ECG cable, 12-
lead ECG cable, paddles and therapy electrodes
Sweep speed 50mm/s, 25mm/s, 12.5mm/s with error less than ±10%
Lead mode 12-lead ( R、L、F、N、C1、C2、C3、C4、C5、C6 or RA、
LA、LL、RL、V1、V2、V3、V4、V5、V6)
Lead selection I、II、III、avR、avL、avF、V1、V2、V3、V4、V5、V6
Waveform display 12 channels
Lead mode 5-lead (R, L, F, N, C or RA,LA, LL, RL, V)
Lead selection I, II, III, avR, avL, avF, V,
Waveform display 2 channels
Lead mode 3-lead ( R, L, F or RA, LA, LL)
Lead selection I, II, III,
Waveform display 1 channel
Range of ECG signal ±0.2~±8mV
Overload protection Load 1V, power frequency and difference mode alternating voltage have
no damage within 10s (p-v)
Respiration, lead off Measuring electrode <0.1µA

II-5
Product Specifications

detection and active noise Drive electrode<1µA


suppression
Range of QRS amplitude Range of 0.5mV~5mV
and interval amplitude (p-v
RTI)
Range of QRS 70ms~120ms
width(adult)
Range of QRS 40ms~120ms
width(pediatric/ne
onate)
No response for a) signals with amplitude (p-v RTI)
the following ≤0.15mV(except from pediatric/neonate operating
signals mode)
b) signals with 1mV amplitude and 10ms width
(except from neonate/ pediatric operating mode)
Power frequency voltage >100µV(p-v)
tolerance
Notch filter Power frequency interference inhibition capacity≥20 dB
Monitor and cure mode: supporting 50/60 Hz notch function
Diagnosis mode: supporting setting 50/60 Hz notch manually
Drifting tolerance Amplitude of pyramidal 4mV
wave (p-v RTI)
Amplitude of QRS wave (p- 0.5 mV
v RTI)
Width of QRS wave 100ms
Repetition rate of QRS wave 80bpm
HR measurement range and Adult 15~300bpm
error Pediatric/neonate 15~350bpm
Error ±1% or ±1 bpm, the large one
Adult maximum 300 bpm
measurement value
Pediatric/neonate maximum 350 bpm
measurement value
Range of alarm limits Adult Upper limit: (lower limit+2)~300bpm
Lower limit: 15bpm~(upper limit-2)bpm
Pediatric/neonate Upper limit: (lower limit+2)~350bpm
Lower limit: 15bpm~(upper limit-2)bpm
Alarm resolution ±1 bpm
Error ±1 bpm
Starting time for cardiac <10s
arrest, the high heart rate
alarm and the lower heart
rate alarm
Frequency characteristic Cure mode : 1 Hz~20 Hz (-3.0dB~+0.4dB);
Monitor mode: 0.5 Hz~40 Hz (-3.0dB~+0.4dB);

II-6
Product Specifications

Diagnosis mode: 0.05Hz~150 Hz (-3.0dB~+0.4dB);


ST mode: 0.05 Hz~40 Hz (-3.0dB~+0.4dB);
Dynamic range of inputting Amplitude of ±5mV
input signal
Rate(RTI) 320mV/s
offset voltage of -650~+650mV
direct current
Changes in output ±10%
signal
Display of the No declining below 50%
non-operation
condition
(displaying the
degree of
attenuation )
Input impedance No more than 20% signal attenuation (0.67Hz~40Hz)
System noise (p-v RTI) <25µV
Multichannel crosstalk <5%
Gain control and stability Gain selection All display 2.5mm/mV
5.0mm/mV,10mm/mV,
20mm/mV
Permanent 10mm/mV
display
Gain control Supporting changing gains manually
gain variation in No more than 0.66%/min
every minute
General gain No more than ±10%
variation in an
hour
Time reference selection Time reference Permanent display 25mm/s
and accuracy selection
Impermanent 12.5 mm/s, 25 mm/s, 50
display mm/s
Accuracy ±10%。
Output display Width of channels 30mm
Aspect rate 0.4s/mV
Input signals reconstruction General error of ±20% or ±100µV, the larger one
accuracy system
Frequency Sinusoidal 0.67~40Hz(attenuation -3dB)
response input
Response to the Amplitude of the wave peak
input pyramidal attenuates from 0 to 25 Hz
wave with width
of 20ms
Response to the Deviation(RTI) No more than 0.1mV

II-7
Product Specifications

0.3 mVs shock in Slop (RTI) No more than 0.30mV/s


its range
Electrode No less than ±5%
weighting factor
hysteresis effect of No more than 0.5mm
15 mm deviation
Error of calibration voltage ±5%
1mV
CMRR Diagnostic mode>90dB
Monitor mode >105dB
Therapy mode >105dB
ST mode >105dB
Baseline control and recovery time 3s
stability after resetting
Drift rate within 10µV/s
10s
Baseline drift ≤500µV
within 1h
Baseline drift ≤50µV/℃
under work
temperature
Pacing pulse inhibition Amplitude: ± 2mV ~ ± 700mV, width: 0.1ms ~ 2.0ms, overshoot less
without overshoot than 0.05ɑp , settling time less than 5μs; the start rise and fall time of
pulse, all no more than100μs; the start time of pulse goes ahead of the
QRS wave’s start time in or less than 40ms, that is to say, having the
same pulse earlier than that pacing pulses in 150ms to 250ms.
Inhibition of the pacing Minimum input slew rate: 830mV/s
pulse detector for fast ECG
signal
Display capabilities of Amplitude: ± 2mV ~ ± 700mV, width: No less than 0.2mV
pacing pulses 0.5ms ~ 2.0ms, maximum rise time:
100µS, display of ECG when 100 pacing
pulses appear per minute.
ST segment measurement Range -2.0mV-+2.0mV
Accuracy -0.8 mV~+0.8mV: ±0.02mV or ±10%, the larger one
Resolution 0.01 mV
Upper limit:(lower limit +0.2)~2.0 mV;
ST alarm limits and error Lower limit: -2.0~(upper limit -0.2 mV)
Error:±0.1 mV
Type of arrhythmia Asystole, ventricular fibrillation / tachycardia, ventricular rhythm, a
single ventricular ectopic, two ventricular ectopic, multiple ventricular
ectopic, ventricular ectopic bigeminy, trigeminy, the R- on –T,
tachycardia, bradycardia missed beat, extreme tachycardia, extreme
bradycardia, irregular heartbeat, PVCs two high
Leakage current < 10 uA

II-8
Product Specifications

Electrosurgical interference The change of HR is not more than ±10% compared with the HR
inhibition without interference
Electrotome protection Cut mode: 300W; coagulation mode: 100W, recovery time:≤10s

HR calculation

Maximum T-wave 1.2mV


inhibition capability
HR calculation As required in Section 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the HR
is calculated like this: if all of the last 3 RR intervals are longer than
1200ms, the average of the last 4 RR intervals is the HR; in other cases,
the average of the last 12 RR intervals (with the longest interval and
shortest interval excluded) is the HR.
HR calculation accuracy and As required in Section 201.12.1.101.17 b) 4) of IEC 60601-2-27, the HR
response to arrhythmia is displayed as follows after the 20s stable segment:
HR is displayed as follows after the 20s stable segment:
Figure A1, Ventricular bigeminy: 80±1bpm
Figure A2, Slow alternating ventricular bigeminy: 60±1bpm
Figure A3, Rapid alternating ventricular bigeminy: 120±1bpm
Figure A4, Bidirectional systoles: 90±2bpm
Response time for HR As required in Section 201.7.9.2.9.101 b) 5) of IEC 60601-2-27: the
change response time for a HR change from 80bpm to 120bpm or from 80bpm to
40bpm is less than 10s.
Tachycardia alarm start time Meet the requirements of IEC 60601-2-27: Clause 201.7.9.2.9.101 b) 6),
the waveform:
Figure B1 1 - range: 11s
Figure B1 0.5 - range: 11s
Figure B1 2 - range: 11s
Figure B2 1 - range: 11s
Figure B2 0.5 - range: 11s
Figure B2 2 - range: 11s

Pacing pulse
Pacing marker There will be pacing marker for the pacing pulse that meets the
following conditions:
Amplitude: ±2~±700mV
Width: 0.1~2ms
Uprising time: 10~100μs
Pacing inhibition Comply with requirements of IEC60601-2-27, and suppress pulses that
meet the following conditions:
Amplitude: ±2~±700mV
Width: 0.1~2ms
Uprising time: 10~100μs
Minimum input slew rate: 10V/s RTI

II-9
Product Specifications

2.10 Resp Specifications


Item Specifications
Technique Thoracic impedance
RESP lead Lead I and II available
Measurement Range Adult 0bpm-120bpm
range and
Pediatric/neonate 0bpm-150bpm
accuracy
Accuracy ±1bpm
Alarm limits and Adult Upper limit (Lower limit+2)~120bpm
error Lower limit 6bpm~(Upper limit-2)bpm
Pediatric/neonate Upper limit (Lower limit+2)~150bpm
Lower limit 6bpm~(Upper limit-2)bpm
Error ±1bpm
Apnea alarm time Apnea alarm time Adult:10s  60s
and error Pediatric/neonate: 10s 20s
Error ±5s
CVA recognition S8/S6 Defibrillator Monitor will give alarm message in the event of the same HR
function and RR

2.11 NIBP Specifications


Item Specifications
Measurement Oscillometric method
technique
Measurement Adult Systolic pressure 5.3~36kPa(40~270mmHg)
range and Diastolic pressure 1.3~28.7kPa(10~215mmHg)
accuracy Mean arterial pressure 2.7~31.3kPa(20~235mmHg)
Pediatric Systolic pressure 5.3~26.7kPa(40~200mmHg)
Diastolic pressure 1.3~20kPa(10~150mmHg)
Mean arterial pressure 2.7~22kPa(20~165mmHg)
Neonate Systolic pressure 5.3~20kPa(40~135mmHg)
Diastolic pressure 1.3~13.3kPa(10~100mmHg)
Mean arterial pressure 2.7~14.7kPa(20~110mmHg)
Accuracy 5mmHg; when the measured NIBP exceeds the ranges
described above, there is still reading on the screen but the
accuracy is not specified.
Static pressure 0 mmHg(0 kPa)~300 mmHg(40.0 kPa); ±3 mmHg(±0.4 kPa)
measurement
range and
accuracy
Overpressure Adult 300mmHg
protection range Pediatric 240mmHg
and error Neonate 150mmHg
Error ±3mmHg

II-10
Product Specifications

Alarm limit and Adult High limit:5.6kPa~36kPa(42mmHg~270mmHg);


error Systolic Low limit:5.3kPa~35.7kPa(40mmHg~
268mmHg)
High limit:1.6kPa~28kPa(12 mmHg~
210mmHg);
Diastolic
Low limit:1.3kPa~27.7kPa(10 mmHg~
208mmHg)
High limit:2.9kPa~30.6kPa(22 mmHg~
Mean 230mmHg)Low limit:2.6kPa~30.3(20
mmHg~228mmHg)
Pediatric High limit: 5.6kPa ~ 26.6kPa ( 42mmHg ~
200mmHg)
Systolic
Low limit:5.3kPa ~ 26.3kPa ( 40mmHg ~
198mmHg)
High limit:1.6kPa~22kPa(22mmHg~
165mmHg)
Diastolic
Low limit:1.3kPa~21.7kPa(20 mmHg~
163mmHg)
High limit:2.9kPa~22kPa(22mmHg~
165mmHg)
Mean
Low limit:2.6kPa~21.7kPa(20mmHg~
163mmHg)
Neonate High limit:5.6kPa~18kPa(42mmHg~
135mmHg)
Systolic
Low limit:5.3kPa~17.7kPa(40mmHg~
133mmHg)
High limit:1.6kPa~12.6kPa(12 mmHg~
Diastolic 95mmHg)Low limit:1.3kPa~12.3kPa(10
mmHg~93mmHg)
High limit:2.9kPa~14.6kPa(22mmHg~
110mmHg)
Mean
Low limit:2.6kPa~14.3kPa(20 mmHg~
108mmHg)
Error ±0.1kPa or ±1mmHg, the larger one
Measure mode Manual, auto and continuous
Interval of auto mode 1、2、3、4、5、10、15、30、60、90、
120、180、240、480min
Continuous 5min

II-11
Product Specifications

2.12 SpO2 Specifications


Item Specifications
Display range 1%~100%
Display resolution 1%
Measurement (1) Comen SpO2:
accuracy Measurement range: 0%~100%;
Accuracy: ±2% (measured without motion in adult/pediatric mode) or ±3%
(measured without motion in neonate mode) in the range of 70%~100%
(2) Masimo SpO2:
Measurement range: 1%~100%;
Accuracy: ±2 % (measured without motion in adult/pediatric mode), ±3 %
(measured with motion in adult/pediatric mode) or ±3%(measured without
motion and with motion in neonate mode) in the range of 70%~100%
(3) Nellcor SpO2:
Measurement range: 0%~100%
Accuracy: ±2% (measured without motion in adult/pediatric mode) or ±3%
(measured without motion in neonate mode) in the range of 70%~100%
(4) Accuracy is not specified in other ranges.
Alarm limits and Upper limit (lower limit +1)%~100%
accuracy Lower limit 0%~(upper limit -1)%
Accuracy ±1%
Perfusion index (PI) MasimoSpO2 module has the perfusion index indication function.
Measurement range: 0.02 % 20 %.
Accuracy: not specified.
Resolution: 0.01% in the range of 0.02%9.99%; 0.1% in the range of 10.0%
20.0%.

Masimo Accuracy Footnotes:


1 The Masimo SET technology with Masimo sensors has been validated for no motion accuracy in
human blood studies on healthy adult male and female volunteers with light to dark skinpigmentation in
induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG
monitor. This variation equals ±1standard deviation. Plus or minus onestandard deviation encompasses
68% of the population.
2 The Masimo SET technology with Masimo sensors has been validated for motion accuracy in human
blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in
induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1
to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitudeof 2 to 3 cm in induced hypoxia
studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This
variation equals ±1 standard deviation, which encompasses 68% of the population.
3 The Masimo SET technology has been validated for low perfusion accuracy in bench top testing
against a Biotek Index 2™ simulator and Masimo’s simulator with signal strengths of greaterthan 0.02%
and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals ±1
standard deviation. Plus or minus one standard deviation encompasses 68%of the population.
4 The Masimo SET Technology with Masimo Neo sensors has been validated for neonatal motion

II-12
Product Specifications

accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin
pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at
an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in
induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG
monitor. This variation equals ±1 standard deviation. Plus or minus one standard deviation encompasses
68% of the population. 1% has been added to the results to account for the effects of fetal hemoglobin
present in neonates.
5 The Masimo SET technology with Masimo sensors has been validated for pulse rate accuracy for the
range of 25 -240 bpm in bench top testing against a Biotek Index 2™ simulator. This variation equals ±1
standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
6 Sensor accuracy specified when used with Masimo technology using a Masimo patient cable for LNOP
sensors, RD SET sensors, the LNCS sensors, or the M-LNCS sensors. Numbers represent Arms (RMS
error compared to the reference). Because pulse oximeter measurements are statistically distributed, only
about two-thirds of the measurements can be expected to fall within a range of ± Arms compared to the
reference value. Unless otherwise noted, SpO2 accuracy is specified from 70% to 100%. Pulse Rate
accuracy is specified from 25 to 240 bpm.
7 Masimo M-LNCS, LNOP, RD SET, and LNCS sensors types have the same optical and electrical
properties and may differ only in application type (adhesive/non-adhesive/hook & loop), cable lengths,
optical component locations (top or bottom of sensor as aligned with cable), adhesive material type/size,
and connector type (LNOP 8 pin modular plug, RD 15 pin modular plug, LNCS9 pin, cable based, and
M-LNCS 15 pin, cable based). All sensor accuracy information and sensor application instructions are
provided with the associated sensor directions for use.

2.13 PR Specifications
Item Specifications
Measurement range (1) Comen SpO2 module
and error Measurement range: 20bpm~254bpm; resolution: 1bpm; error: ±1bpm
(2) Masimo SpO2 module
Measurement range: 25bpm~240bpm; resolution: 1bpm; error: ±3bpm
(without motion) and ±5bpm (with motion)
(3) Nellcor SpO2 module
Measurement range: 20bpm~300bpm; resolution: 1bpm; error: ±3bpm in the
range of 20bpm~250bpm, no specified in the range of 251bom~300bpm
Upper limit: (lower limit +1)~350bmp
Alarm limits and
Lower limit: 0~(upper limit -1) bpm
accuracy
±1 bpm

2.14 TEMP Specifications


Item Specifications
Measurement range and Range 0℃~50℃
accuracy Accuracy ±0.1℃
Alarm limits and error Range of alarm limits Upper limit: (lower limit +0.1)~50.0˚C
Lower limit: 0℃~(upper limit -0.1)˚C

II-13
Product Specifications

error ±0.1℃
Display resolution 0.1C
Number of channels Two channels

2.15 CO2 Specifications


Item Specifications
Measurement range Respironics CO2 module
Range: 0mmHg~150mmHg,0%~19.7%, 0kPa~20kPa;
Masino CO2 module
Range: 0mmHg~190mmHg, 0%~25%, 0kPa~25.3kPa;
Comen CO2 module
Range: 0mmHg~150mmHg, 0%~20%, 0kPa~20kPa
CO2 resolution 1mmHg/ 0.1kPa/0.1%
CO2 accuracy a) Respironics CO2 module
1)0mmHg~40mmHg:±2mmHg;
2)41mmHg~70mmHg: ±5%;
3)71mmHg~100mmHg: ±8%;
4)101mmHg~150mmHg:±10%.
b)Masimo CO2 module
1)0mmHg~114mmHg:±1.52mmHg+2%;
2)114mmHg~190mmHg: not specified.
c)Comen CO2 module
1) 0mmHg~40mmHg:±2mmHg;
2) 41mmHg~70mmHg:±5%;
3) 71mmHg~100mmHg:±8%;
4) 101mmHg~150mmHg:±10%.
a) Respironics CO2 module
Adult measurement range: 2rpm~150rpm;
Accuracy: ±1rpm
b) Masimo CO2 module
AwRR measurement
Adult measurement range: 0rpm~150rpm;
range and accuracy
Accuracy: ±1rpm
c) Comen CO2 module
Adult measurement range: 2rpm~150rpm;
Accuracy: ±1rpm

Respironics and Comen CO2 module 0 mmHg~150mmHg or 0 kPa~20kPa


Alarm range
0 mmHg ~ 190mmHg or 0 kPa ~
Masimo CO2 module
25.3kPa
Alarm error ±0.1kPa/±1mmHg

II-14
Product Specifications

2.16 IBP Specifications (only applicable to S8)


Item Specifications
Number of IBP channels Two channels
IBP label ART, PA, CVP, RAP, LAP, ICP, P1, P2
ART 0~40kPa(0~300mmHg)
PA -0.8~16kPa(-6~120 mmHg)
CVP -1.3~5.3kPa(-10~40mmHg)
Measurement range RAP -1.3~5.3kPa(-10~40mmHg)
LAP -1.3~5.3kPa(-10~40mmHg)
ICP -1.3~5.3kPa (-10~40mmHg)
P1, P2 -6.6~40kPa(-50~300mmHg)
Measurement accuracy ±1mmHg or ±2%, the larger one (not including transducer error)
Range of static pressure
-1.3kPa~+40kPa(-50mmHg~+300mmHg)
measurement
Display resolution of static
0.1kPa or 1mmHg
measurement
Static measurement error ±1mmHg or ±2%, the larger one (not including transducer error)
Upper limit: (Lower limit+2)-300 mmHg
ART
Lower limit: 0-(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~120mmHg
PA
Lower limit: -6~(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~40mmHg
CVP
Lower limit: -10~(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~40mmHg
RAP
Lower limit: -10~(Upper limit-2)mmHg
Range of IBP alarm limits
Upper limit: (Lower limit+2)~40mmHg
LAP
Lower limit: -10~(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~40mmHg
ICP
Lower limit: -10~(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~300 mmHg
P1
Lower limit: -50~(Upper limit-2)mmHg
Upper limit: (Lower limit+2)~300 mmHg
P2
Lower limit: -50~(Upper limit-2)mmHg
IBP alarm error ±0.1/±1mmHg
Sensitivity : 5V/V/mmHg
Pressure transducer
Impedance: 300~3000Ω

2.17 Alarm System


Item Specification

The alarm system complies with IEC 60601-1-8.

II-15
Appendix III Cardiac Rhythm Recognition Test

According to the requirements of the standard IEC60601-2-4 and AAMI DF80, the algorithm evaluation
indicators mainly include sensitivity and specificity. The calculation is as follows:

A
Sensitivity 
AC

D
Specificity 
BD
Where: A - true positive, B - false positive, C - false negative, D - true negative
The number of evaluation samples and indicator requirements are shown in the following table:
Rhythm Minimum test sample Result
Shockable
Coarse VF,Fine VF 250 >90% sensitivity
Shockable VT 50 >75% sensitivity
Nonshockable 300 total
NSR 100(arbitrary) >99% specificity
AF, SB, SVT, heart block, 30(arbitrary) >95% specificity
idioventrivular, PVCS, etc.
Asystole 100(for safety) >95% specificity
Unshockable VT 25 Report only
Refer to the AHA recommendations: Automatic External Defibrillators for Public Access Defibrillation:
Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating
New Waveforms, and Enhancing Safety);
ECG test database
The database used for evaluation mainly includes:
 MIT-BIT Malignant Ventricular Arrhythmia Database (VFDB)。
 The American Heart Association Electrocardiographic Database (AHADB) (ANSI/AAMI EC57 standard
requirements).
 MIT-BIT arrhythmia Database (MITDB)(ANSI/AAMI EC57 standard requirements).
 Creighton University Ventricular Tachyarrhythmia Database (CUDB) (ANSI/AAMI EC57 standard
requirements).

The three results of the sample test are evaluated as the criteria for eligibility. See the following table
for details:
Test conclusion
Rhythm Minimum test Actual test Result Standard
sample sample
Coarse VF, Fine VF 250 300 93.6% >90%

III-1
Cardiac Rhythm Recognition Test

Shockable VT 50 80 90.8% >75%


NSR 100 500 100% >99%
AF, SB, SVT, heart 30 50 100% >95%
block,
idioventrivular,
PVCS, etc.
Asystole 100 110 100% >95%
Unshockable VT 25 50 94.6% Report

III-2
Appendix IV System Alarm Information

Some of the most important physiological and technical alarm messages are listed in this section, and some of
the alarm information may not be listed.
XX stands for: certain module names and physiological parameters in the HR, ST, RR, TEMP (including
TEMP1, TEMP2, and TD), SpO2, PR, CO2 (including AwRR, INS, and Fi), NIBP, IBP and other systems.
The corresponding countermeasures are listed for the alarm information. After following the countermeasures,
if the problem persists, please contact your service representative.
Among which, technical alarm category classification: A means that it can be completely cleared, B means
that the sound and light can be cleared, and C means that it cannot be cleared.
And the level of technical alarms is not adjustable after leaving the factory (except ECG and SpO2).
(1) Physiological alarm
Source Default Adjustable level Cause Countermeasures
level
ECG
High-level,
Medium-
XX too high medium-level, and
level
low-level
High-level,
Medium-
XX too low medium-level, and
level
low-level
The value of
Among which, XX stands for ST, ST-I, ST-II, ST-III,
the measured
ST-aVR, ST-aVL, ST-aVF, ST-V, ST-V1, ST-V2, Check the patient's
parameter is
ST-V3, ST-V4, ST-V5, and ST-V6. physiological condition, and
above the
Medium- High-level, and confirm if the patient type and
HR too high upper alarm
level medium-level alarm limit settings are
limit or below
Medium- High-level, and appropriate for the patient.
HR too low the lower
level medium-level
alarm limit.
High-level,
Medium-
PVCs too high medium-level, and
level
low-level
High-level,
Medium-
PVCs too low medium-level, and
level
low-level
The patient's
Check the patient's condition,
ECG Lost for
ECG Lost Low-level Low-level electrodes, cables and lead
the system to
wires.
analyze.
ECG Noise Low-level Low-level
Medium- High-level, and The patient Check the patient's
Heart Pause has condition, electrodes, cables
level medium-level
Medium- High-level, and arrhythmia. and lead wires.
Vent.Rhythm
level medium-level
IV-1
System Alarm Information

Source Default Adjustable level Cause Countermeasures


level
Asystole High-level High-level

Vfib/Vtac High-level High-level

Vent. Brady High-level High-level


Medium- High-level, and
Pause/min
level medium-level
Medium- High-level, and
R ON T
level medium-level
Medium- High-level, and
VT>2
level medium-level
Medium- High-level, and
Couplet
level medium-level
Medium- High-level, and
PVC
level medium-level
Medium- High-level, and
Bigeminy
level medium-level
Medium- High-level, and
Trigeminy
level medium-level
Medium- High-level, and
SVT
level medium-level
Medium- High-level, and
Tachy
level medium-level
Pacer Not Medium- High-level, and
Capture level medium-level
Pacer Not Medium- High-level, and
Pacing level medium-level
Bradycardia Medium- High-level, and
Threshold level medium-level
Medium- High-level, and
Missed Beat
level medium-level
Medium- High-level, and
ARR
level medium-level
Medium- High-level, and
Noise signal
level medium-level
Signal
Medium- High-level, and
amplitude is too
level medium-level
small
Medium- High-level, and
SVT
level medium-level
Extreme Tachy High-level High-level

Extreme Brady High-level High-level

SpO2

IV-2
System Alarm Information

Source Default Adjustable level Cause Countermeasures


level
High-level, and
SpO2 too high High-level
medium-level The value of
High-level, and the measured
SpO2 too low High-level Check the patient's
medium-level parameter is
physiological condition, and
High-level, above the
confirm if the patient type and
PR too high High-level medium-level, and upper alarm
alarm limit settings are
low-level limit or below
appropriate for the patient.
High-level, the lower
PR too low High-level medium-level, and alarm limit.
low-level
The patient's
pulse signal is Check the patient's condition,
No Pulse High-level High-level too weak for SpO2 sensor and measurement
the system to site.
analyze.
NIBP
The value of
SYS/MAP/DIA Medium- High-level, and
the measured
too high level medium-level Check the patient's
parameter is
physiological condition, and
above the
confirm if the patient type and
upper alarm
SYS/MAP/DIA Medium- High-level, and alarm limit settings are
limit or below
too low level medium-level appropriate for the patient.
the lower
alarm limit.
RESP
High-level, The value of
Medium-
RR too high medium-level, and the measured
level Check the patient's
low-level parameter is
physiological condition, and
above the
confirm if the patient type and
High-level, upper alarm
Medium- alarm limit settings are
RR too low medium-level, and limit or below
level appropriate for the patient.
low-level the lower
alarm limit.
The patient's
RESP signal is
No Breaths High-level High-level too weak for
the system to
Check the patient's condition,
analyze.
electrodes, cables and lead
The patient's
wires.
heartbeat
Resp Artifact High-level High-level interfered with
the RESP and
the RR is not

IV-3
System Alarm Information

Source Default Adjustable level Cause Countermeasures


level
measured
correctly.
IBP
The value of
Medium- High-level, and
ZZ too high the measured
level medium-level
parameter is Check the patient's
above the physiological condition, and
upper alarm confirm if the patient type and
Medium- High-level, and
ZZ too low limit or below alarm limit settings are
level medium-level
the lower appropriate for the patient.
alarm limit.
Among which, ZZ stands for IS1, ID1, IM1, IS2, IM2, and ID2

TEMP
Medium- High-level, medium-
T1 too high The value of
level level, and low-level
the measured
Medium- High-level, medium-
T1 too low parameter is Check the patient's
level level, and low-level
above the physiological condition, and
Medium- High-level, medium-
T2 too high upper alarm confirm if the patient type and
level level, and low-level
limit or alarm limit settings are
Medium- High-level, medium-
T2 too low below the appropriate for the patient.
level level, and low-level
lower alarm
Medium- High-level, medium-
TD too high limit.
level level, and low-level
CO2
Medium-
CO2 too high Not adjustable
level
The value of
Medium-
CO2 too low Not adjustable the measured
level
parameter is Check the patient's
Medium- High-level, medium-
AwRR too high above the physiological condition, and
level level, and low-level
upper alarm confirm if the patient type and
Medium- High-level, medium-
AwRR too low limit or alarm limit settings are
level level, and low-level
below the appropriate for the patient.
Medium- High-level, and
INS too high lower alarm
level medium-level
limit.
Medium- High-level, and
INS too low
level medium-level

(2) Technical alarm


Alarm Alarm Alarm
Source Cause Countermeasures
information level level
Error X occurs Reboot and try again. If
XX XX Init Err High A
during initialization the error persists, contact
IV-4
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
of XX module the manufacturer for
The XX module repair.
XX Comm cannot
High C
Stop communicate with
the main system.
The XX module
cannot
XX Comm
High A communicate
Err
normally with the
main system.
The alarm limit of
XX Alm Lmt the XX parameter is
XX Low C
Err accidentally
changed.
The measured value Contact the manufacturer
of the XX for repair.
XX parameter is beyond
XX Low C
Overrange the measurement
range that the
system can perform.
The ECG lead wire
ECG Lead Check the connection of
Low B is not connected
Off the ECG lead wire.
well.
ECG YY
Lead Off (YY
stands for: V, The ECG YY lead
Check the connection of
LL, LA, RA, Low B wire is not
the YY lead wire.
ECG V1, V2, V3, connected well.
V4, V5, and
V6)
Check the connection of
Large interference the ECG lead wire, check
ECG Noise Low A signals appear in the current condition of
the ECG signal. the patient, and whether
there is a big action.
The SpO2 sensor
SpO2 Finger
Low B has been removed
Off
from the finger.
Check the connection of
SpO2 No
Low B the SpO2 sensor.
SpO2 Sensor The SpO2 sensor is
SpO2 Low not connected well.
Low C
Signal
NELLC NELLCOR module If the fault still exists after
Low C
failure, error, system reset the system fails to reset or

IV-5
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
resetting restart the monitor, please
contact the manufacturer
for repair.
The SpO2 sensor is Check the connection of
not connected well the SpO2 sensor and the
Search Pulse Low B
or the patient's arm current condition of the
is moving. patient.

The measured value


Please follow the
SpO2 C is beyond the
Low manufacturer's stated
Overrange claimed measuring
range for measurement.
range.

Replace other fingers, or


The peripheral detect the presence or
SpO2 Low
C circulation is not absence of limb
Perfusion Low
smooth compression resulting in
(masimo)
poor peripheral
circulation.

Check and replace the


SpO2 Sensor
C Sensor failure sensor. If the fault
Fault Low
persists, contact the
(masimo)
manufacturer for repair.
Check the connection of
SpO2 External the SpO2 lead wire, check
Interference Low C interference is too the current condition of
(masimo) strong the patient, and whether
there is a big action.

The patient (sensor) Check that the SpO2 probe


Too Much receives too much is clamped, remove or
Light Low C light. Improper reduce the light, cover the
(masimo) fabric covers the sensor from light, and
sensor detector. reposition the sensor.

SpO2 Check and replace the


The SpO2 module
Unknown C probe. If the fault persists,
Low cannot recognize
Sensor contact the manufacturer
the probe.
(masimo) for repair.
Check and replace the
SpO2 No The cable is not
cable. If the fault persists,
Cable Low B connected or not
contact the manufacturer
(masimo) connected well.
for repair.

SpO2 No C The SpO2 module Check and replace the


Low
Adhesive cannot recognize probe. If the fault persists,

IV-6
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
Sensor the probe. contact the manufacturer
(masimo) for repair.

SpO2 Module
C Module failure Return to the
Error Low
manufacturer for repair.
(masimo)
TEMP1
Low A The TEMP sensor
Sensor Off Check the connection of
TEMP is not connected
TEMP2 the TEMP sensor.
Low A well.
Sensor Off
NIBP Selftest NIBP initialization Select the reset function in
High A
Err. error the NIBP menu. If the
NIBP error persists, please
NIBP Comm
High A communication part contact the manufacturer
Error
has a problem. for repair.
NIBP cuff is not Please reconnect the NIBP
Loose Cuff Low A
connected well. cuff.
There is gas leakage
Pneumatic
Low A at the NIBP gas
Leak
circuit.
A problem occurs
during the
measurement of
curves, and the
Pressure
Low A system is unable to
Overrange
conduct
measurement
NIBP analysis and Check the connection of
calculation. each part or update a cuff.
NIBP cuff is not If the fault persists, please
connected well, or contact the manufacturer
Air Leak Low A
there is gas leakage for repair.
at the gas circuit.
A problem occurs
during the
measurement of
curves, and the
Air Pressure
Low A system is unable to
Error
conduct
measurement
analysis and
calculation.
A problem occurs Check if the patient type
Weak Signal Low A during the setting is correct, and
measurement of check the connection of
IV-7
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
curves, and the each part or update a cuff.
system is unable to If the fault persists, please
conduct contact the manufacturer
measurement for repair.
analysis and
calculation.
It may be that the
Cuff Type cuff used does not
Low A
Error match the type of
patient being set.
Excessive The patient's arm
Low A
Motion moves.
Signal
Low A A problem occurs
Saturated Check the connection of
during the
NIBP System each part, and the patient's
High A measurement of
Failure condition, and measure
curves, and the
NIBP again. If the fault persists,
system is unable to
Measure Low A please contact the
conduct
Timeout manufacturer for repair.
measurement
NIBP
analysis and
Measure Low A
calculation.
Failed
Check if the gas circuit is
clear and the patient's
Gas circuit may be condition, and measure
Over Pressure Low A
folded. again. If the fault persists,
please contact the
manufacturer for repair.
Check the NIBP's gas
circuit to see if there is
An illegal reset any blockage before
NIBP Reset
Low A occurs during NIBP taking measurements. If
Error
measurements. the error persists, please
contact the manufacturer
for repair.
IBP1 Lead Check or re-plug the IBP
Off IBP sensor is in sensor. If the fault
IBP Low B
IBP2 Lead poor contact. persists, contact the
Off manufacturer for repair.
Select the CO2 operating
CO2 is The CO2 operating
Low mode as the measurement
sleeping mode is on standby.
CO2 mode.
CO2 The sampling tube Check and replace the
Low B
Sampling is blocked. sampling tube. If the fault

IV-8
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
Line Clogged persists, contact the
CO2 No The sampling tube manufacturer for repair.
Sample Line Low B is not connected or
(Masimo) has poor contact.
The measured value Please follow the
CO2 Out Of
is beyond the manufacturer's stated
Accuracy Low C
claimed accuracy accuracy range for
Range
range. measurement.
CO2 internal
temperature is
Low C
beyond the
range.
CO2 Span Cal
Error Low C
(Masimo)
Factory
Return to the
Calibration Module failure
Low C manufacturer for repair.
Lost
(Masimo)
Speed Out Of
Bounds Low C
(Masimo)
Pressure
Overrange Low C
(Masimo)
CO2 Span
CO2 range is Return to the
Calibrating... Low C
calibrating manufacturer
(Masimo)
Replace
Adapter Low C Adapter exception Check and replace the
(Masimo) adapter. If the fault
The adapter is not persists, contact the
No Adapter
Low C connected or has manufacturer for repair.
(Masimo)
poor contact.
Enter the CO2 setting to
Need Zero CO2 needs to be return to zero. Returning
Low C
(Masimo) zeroed. zero here is equal to zero
calibration.
Software
Error Low C Software error Reboot.
(Masimo)
Hardware Check and replace the
Error Low C Hardware error sensor. If the fault
(Masimo) persists, contact the
IV-9
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
manufacturer for repair.

Low Battery High A Please charge the battery


Battery is low.
in time.

Battery 1 Please charge the battery


Low A Battery is low.
Low in time.

Battery 2 Please charge the battery


Low A Battery is low.
Low in time.

Battery 1 Please replace the battery.


Low C Battery aging
Aging Restart the instrument. If
the fault persists, please
Battery 2 contact the manufacturer
Low C Battery aging
Aging for repair.

Battery 1 The battery has Check the battery for


High C
Fault failed. compatibility, damage, or
battery replacement.
Restart the instrument. If
Battery 2 The battery has the fault persists, please
High C
Fault failed. contact the manufacturer
Battery
for repair.

Batteries 1 and 2
No Battery Low A Please install the battery.
are not installed.

Battery 1 is not
No Battery 1 Low A Please install the battery 1.
installed.

Battery 2 is not
No Battery 2 Low A Please install the battery 2.
installed.
Please replace the battery. If
the problem persists, please
Battery failure or
Battery 1 contact the maintenance
Medium C power board charging
personnel.
Charge Fault
circuit failure

Please replace the battery. If


the problem persists, please
Battery failure or
Battery 2 contact the maintenance
Medium C power board charging
personnel.
Charge Fault
circuit failure

The input signal is


Treatment Paddle Over Reconnect the lead wires
Low A out of the
module Load or electrode pads; or treat
measurement
the patient's skin.
range.

IV-10
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level

The input signal is


Reconnect the lead wires
Pad Over out of the
Low A or electrode pads; or treat
Load measurement
the patient's skin.
range.

Electrode pad or Reconnect the lead wires


Pad/Plate Off Low A eletrode plate or electrode pads; or treat
detachment the patient's skin.

Self-test items
Last self-test
Low C failed in the last Perform self-test again.
has failed.
self-test.

Restart the instrument. If


Defibrillation
Defib Comm the fault persists, please
High C function
Stop contact the manufacturer
malfunctions
for repair.

Restart the instrument. If


Defibrillation
Defib Comm the fault persists, please
High C function
Err contact the manufacturer
malfunctions
for repair.

Restart the instrument. If


Defibrillation
the fault persists, please
Defib Fault High C function
contact the manufacturer
malfunctions.
for repair.

Restart the instrument. If


Pacing function the fault persists, please
Pace Fault High C
malfunctions. contact the manufacturer
for repair.

Pace Unlrmal
High A Pacing failure Re-pacing
Stop
Fault code,
defibrillation
malfunction or
Restart the instrument. If
simultaneous
Defib/Pace the fault persists, please
High C defibrillation
Malfunction contact the manufacturer
malfunction and
for repair.
pacing malfunction.

Fault code, the Replace the low-pressure


Failed Energy
High C treatment board board and the high-pressure
Released
self-discharge board. Restart the

IV-11
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
circuit is abnormal. instrument. If the fault
persists, please contact the
manufacturer for repair.

ECG Lost Low C Fault code None

Restart the instrument. If


Last self-test Power-on self-test is the exception persists,
Low C
has failed. abnormal. please contact the
manufacturer for repair.

Restart the instrument. If


Power
the fault persists, please
Voltage Low C Fault code
contact the manufacturer
Abnormal
for repair.

Restart the instrument. If


Power Board the fault persists, please
Low C Fault code
RTC Error contact the manufacturer
for repair.

Restart the instrument. If


Internal Temp the fault persists, please
Low C Fault code
Too High contact the manufacturer
for repair.

Fault code, power Restart the instrument. If


Power Board board failure or unit the fault persists, please
High C
Comm Stop communication contact the manufacturer
failure for repair.

Fault code, button Restart the instrument. If


Key Board board failure or unit the fault persists, please
High C
Comm Stop communication contact the manufacturer
failure for repair.

No Record The printer is out of Please load new printing


Low A
Paper paper. paper.

Recorder has a Check if the recorder is


Recorder
Recorder Low C communication installed correctly or
Comm Error
error. replace the recorder.
Record after cooling.
Recorder Recorder works for a
Low A
Head Hot long time. Output

No SD card No SD card
Low A Install SD card.
Others exist! installed

SD Storage Low A Storage is full. Empty or reduce storage.

IV-12
System Alarm Information

Alarm Alarm Alarm


Source Cause Countermeasures
information level level
Full

(3) Prompt information

SOURCE ALARM INFORMATION ALARM LEVEL CAUSE


Manual Measuring... None
Calibrating... None
Leakage Test... None
Resetting... None
Continual measuring... None
Please Start None
Reset For Error None
NIBP
Auto Measuring... None
Leakage Test Stopped None
Measure Stopped None
Over Pressure None
Reset Failed None
Venipuncture Start None
Venipuncture Stop None

IBP1 Zeroing None

IBP2 Zeroing None The system prompts only the


monitor to prompt for a
IBP1 Zero Succeeded None
IBP function or an action that is
IBP2 Zero Succeeded None being operated.

IBP1 Zero Failed None

IBP2 Zero Failed None


Zeroing None
CO2 zero CO2 Zeroing None
calibration CO2 Zero Succeeded None
CO2 Zero Failed None
ECG ECG Calibrating None
ECG Alarm Disabled! None
Cal...can't monitor! High
Alarm
prohibition Resp Alarm Disabled! None
prompt
TEMP Alarm Disabled! None
information
SpO2 Alarm Disabled! None
NIBP Alarm Disabled! None

IV-13
System Alarm Information

SOURCE ALARM INFORMATION ALARM LEVEL CAUSE

IBP Alarm Disabled! None


CO2 Alarm Disabled! None

Defib Alm Disabled None

Ip conflict None

Import Succeeded None

Import Failed None


Config Load Success None
Config Load Failed None
Delete Config Succeeded None

Delete Config Failed None

Sampling None
Relearn None
Arr Learning None
The same module exists,only
one can be kept! None

User Test Due None


Formatting SD Card None
Cannot format SD card None
Format SD Card Succeeded None
Rebuilding Index... None
CMS Connected None
CMS Disconnected None
U-disk Connected None
U-disk Disconnected None
Cal...can't monitor! None
Recording ... None
Recorder Comm Error None

IV-14
Appendix V Factory default configuration

(1) General settings


Configuration item Default value Remark
Pat Type Adu
Language selection Chinese
Date Format YYYY-MM-DD
Time format 12h
Brightness 2
Key Vol 5

(2) Manual defibrillation settings

Configuration item Default value Remark


External defibrillation energy
200J
default value
Internal defibrillation energy
default value 10J

Auto Disarm Time 60s


Sync Keep No
Remote Sync Input ON
Charge Tone Vol Medium
Contact impedance indication OFF

(3) AED settings

Configuration item Default value Remark


Serial Shock Times 1
First Shock Energy 200J ≤ second
Second Shock Energy 300J ≥ first, and ≤ third.
Third Shock Energy 360J ≥ second
Auto Disarm Time 30s
Pre-Shock CPR Time OFF
CPR Time 120s
CPR Metronome ON
CPR mode 30:2
NSA Process Mode CPR
Voice Prompt ON
Voice Volume High
V-1
Factory default configuration

Voice Interval 30s


Audio Recording OFF

(4) Pacing settings

Configuration item Default value Remark


Pace Rate 70ppm
Pace Elec 30mA
Pace Mode On-demand pacing

(5) Event tag settings

Configuration item Default value Remark


Event Save Wave1 II
Event Save Wave2 I
Event Save Wave3 PLETH
EVENT A SIMPLE
EVENT B LIDOCAINE
EVENT C ATROPINE
EVENT D NITROGLYCERIN
EVENT E MORPHINE
EVENT F CANNULA
EVENT G VENOUS TRANSFUSION
EVENT H ADENOSINE

(6) Record settings

Configuration item Default value Remark


Actual Charge Energy OFF
Grid OFF
Charge Event OFF
Electric shock event OFF
User Event OFF
12-Lead Report OFF
Auto Check Report OFF
RT Record Time 8s
Record output speed 25 mm/s

V-2
Factory default configuration

(7) Alarm settings

Configuration item Default value Remark


Alm Vol 2
Alm Rec Time 8s
Alm Pause Time 2min
Alarm delay time Not Allowed
Min. Alm Volume 2
Alarm mute prompt OFF
Reminder Interval 1min
Reminder Volume 1

(8) 12-lead settings

Configuration item Default value Remark

Report Format 3X4

(9) Network settings

Configuration item Default value Remark

Net Bed 1 User settings


Local IP 200.200.200.10
Subnet Mask 255.255.255.0
Service IP 200.200.200.100

(10) Detection settings

Configuration item Default value Remark

User Test Prompt OFF


Auto Test Time 3:00

(11) Event settings


Name General OR ICU NICU CCU
Waveform 1 I
Waveform 2 II
Waveform 3 PLETH

(12) Module Color


Name General OR ICU NICU CCU
ECG Green
Waveform/parameter
SpO2 Cyan
color
RESP Yellow
V-3
Factory default configuration

NIBP White
TEMP White
CO2 Yellow
IBP Red

(13) ECG settings


Name General OR ICU NICU CCU
Cascade switch OFF
Lead name II
Gain X1
Sweep 25 mm/s
Filter Mode Monitor
Lead Type 5-lead
Calculate Lead II
HR Source ECG
Alarm switch ON
Alm Record OFF

Alm Level Medium

Power frequency ON (50HZ)


suppression
Smart Lead Off OFF
Adu Ped Neo
HR alarm limit Upper limit 120 160 200
Lower limit 50 75 100
(14) RESP settings

Configuration item Default value Remark

Alm Level Medium


Alm Record OFF
Display color Yellow
Lead II
Waveform speed 12.5mm/s
Gain X1
Apnea 20s
Enhance Filter OFF
Adu Ped Neo

RESP alarm limit Upper limit 30 30 100


Lower limit 8 8 30

V-4
Factory default configuration

(15) ST default settings

Name General OR ICU NICU CCU


ST Analysis OFF
Alarm switch OFF

Alm Level Medium

Alm Record OFF

Limit (-0.20, 0.20)

(16) Arrhythmia default settings


Name Genera OR ICU NICU CCU
Arrhythmia analysis
OFF
switch
ADU 120
TACHY
PED
threshold 160
NEO
Extreme ADU 160
tachycardi PED 180
a threshold NEO 200
ADU
Brady PED 40
NEO
Extreme ADU 40
bradycardi PED
40
a threshold NEO
Arrhythmia alarm switch All OFF
Arrhythmia alarm record All OFF
The alarm level of ASY, VT, VF, extreme tachycardia, and extreme
Arrhythmia alarm level
bradycardia are high-level alarms, while the others are medium-level alarms.

(17) RESP settings


Name General OR ICU NICU CCU
Gain X1
Enhance Filter ON
Sweep 12.5 mm/s
Apnea alarm 20s
Resp Lead RA-LL(II)
Alarm switch ON
Alm Level Medium
Alm Record OFF
ADU
(8 --- 30)
Limit PED
NEO (30--- 100)

V-5
Factory default configuration

(18) SpO2 settings


Name General OR ICU NICU CCU
Sweep 25 mm/s
Sat-Second(Nellcor) 50s
Fast Sat OFF
Average Time (Masimo) 8s
Smart Tone ON
Sensitivity (Masimo) APOD
Signal IQ ON
Alarm switch ON
Alm Record OFF
Alm Level (Nellcor) High
SpO2 alarm ADU
limit PED (90 --- 100)
(Nellcor) NEO
SpO2 alarm ADU
limit
PED
(Masimo (85 --- 100)
and Digital NEO
SpO2)

(19) PR settings

Name General OR ICU NICU CCU


Alarm switch ON
Alm Record OFF
PR source SpO2
Alm Level High
Adults Children Newborns
Upper limit 120 160 200
PR alarm limit Lower limit 50 75 100

(20) NIBP settings

Name General OR ICU NICU CCU


Pat Type Adu
Measure Mode Manual
Interval 1min
ADU 160
Initial
PED 120
Pressure
NEO 100
Alarm switch ON
Alm Record OFF
Alm Level Medium
Adults Children Newborns
NIBP alarm limit SYS Upper limit 160 120 90

V-6
Factory default configuration

Lower limit 90 70 40
Upper limit 110 90 70
MAP Lower limit 60 50 25
Upper limit 90 70 60
DIA Lower limit 50 40 20

(21) CO2 settings

Name General OR ICU NICU CCU


Gain X1
Sweep 6.25 mm/s
Work Mode Measurement
O2 Compensate
(Respironics) 16
O2 Compensate
(Masimo) High
Balance Gas (National
Medical, and Bicom) Room Air
Altitude Unit m
Altitude (National
Medical, and Bicom) 0.0 m
Baro.Pressure 760mmHg
N2O compensation switch
(Masimo) OFF
No Breaths Timeout 20s
Alarm switch ON
Alm Record OFF
Adults Children Newborns
Upper limit 50 50 45
CO2 Lower limit 25 25 30
Upper limit 4 4 4
INS Lower limit 0 0 0
Upper limit 30 30 100
CO2 alarm limit AWRR Lower limit 8 8 30

(22) IBP Settings


Name General OR ICU NICU CCU
Pressure IBP1 ART
Label IBP2 CVP
PA
LAP
Sweep 25 mm/s
Filter Mode Normal
SPV display OFF
Alarm switch ON
V-7
Factory default configuration

Alm Record OFF


Alm Level Medium
ART, P1, P2, LV, Ao, UAP, BAP and FAP settings
Scale (0,150)
SYS alarm ADU (90,160)
limit
PED (70,120)

NEO (55,90)

MAP ADU (70,110)


alarm limit

PED (50,90)

NEO (35,70)

DIA alarm ADU (50,90)


limit PED (40,70)
NEO (20,60)
PA Settings
Scale (0,100)
SYS alarm ADU (10,35)
limit
PED (24,60)

NEO

MAP ADU (0,20)


alarm limit
PED (12,26)

NEO

DIA alarm ADU (0,16)


limit
PED (-4,4)

NEO

CVP, LAP, RAP, ICP, UVP and IAP settings


Scale (0,40)
MAP ADU (0,10)

V-8
Factory default configuration

alarm limit PED (0,4)


NEO

(23) TEMP Settings


Name General OR ICU NICU CCU
Alarm switch ON
Alm Record OFF
Alm Level Medium
ADU
T1 alarm (36.0 --- 39.0)
PED
limit
NEO
ADU
T2 alarm (36.0 --- 39.0)
PED
limit
NEO
ADU
TD alarm
PED (0 .0 --- 2.0)
limit
NEO

(24) User Maintenance Settings


Name General OR ICU NICU CCU
Wave Draw MONO
Waveform line Thin
Analog Out OFF
Alarm mute
OFF
prompt
Reminder
1min
Interval
Alarm tone
1
Alarm volume
settings Min. Alm
2
Volume
Alm Pause
2min
Time
Alarm delay
Not Allowed
time

V-9
Appendix VI EMC

Warning
 Use of the S8/S6 adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, the S8/S6 and the other equipment
should be observed to verify that they are operating normally.
 Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of the S8/S6 could result in increased electromagnetic emissions or decreased
electromagnetic immunity of the S8/S6 and result in improper operation.
 Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the S8/S6, including cables specified by the manufacturer. Otherwise,
degradation of the performance of the S8/S6 could result.

declaration - electromagnetic emission


Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Clause 5
flicker emissions
IEC 61000-3-3

declaration - electromagnetic immunity


Immunity test IEC 60601 test level Compliance level
Electrostatic ±8 kV contact ±8 kV contact
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, ±15 kV air
IEC 61000-4-2 ±15 kV air
Electrical fast ± 2 kV for power supply ±2 kV for power supply lines
transient/burst lines
±1 kV for input/output lines
IEC 61000-4-4 ± 1 kV for input/output
lines
Surge ±0.5kV, ±1 kV line(s) to ±0.5kV, ±1 kV line(s) to lines
IEC 61000-4-5 lines
±0.5kV, ±1 kV, ±2 kV line(s) to earth
± 0.5kV, ± 1 kV, ± 2 kV
line(s) to earth
Voltage dips, 0 % UT; 0.5 cycle At 0°, 0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°,
short 45°, 90°, 135°, 180°, 270°and 315°
interruptions and 225°, 270°and 315°

VI-1
EMC

voltage 0 % UT; 1 cycle and


variations on 0 % UT; 1 cycle and 70 % UT; 25/30 cycles
power supply 70 % UT; 25/30 cycles Single phase: at 0°
input lines Single phase: at 0°
IEC 61000-4-11
0 % UT; 250/300 cycles
0 % UT; 250/300 cycles
Power frequency 30 A/m 30 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.

declaration - electromagnetic immunity


Immunity test IEC 60601 test Compliance level
level
Conducted RF 3V 3V
IEC 61000-4-6 0.15 MHz to 80 0.15 MHz to 80 MHz
MHz 6 V in ISM bands between 0.15 MHz and 80 MHz
6 V in ISM bands
between 0.15 MHz
and 80 MHz
Radiated RF 3V/m 3V/m
IEC 61000-4-3 80 MHz to 2.7
GHz

declaration - IMMUNITY to proximity fields from RF wireless communications equipment


Immunity IEC60601 test level Compliance level
test
Test Modulation Maximum Immunity
frequency power level
Radiated 385 MHz **Pulse 1.8W 27 V/m 27 V/m
RF Modulation:
IEC 18Hz
61000-4-3 450 MHz *FM+ 5Hz 2W 28 V/m 28 V/m
deviation:
1kHz sine
710 MHz **Pulse 0.2 W 9 V/m 9 V/m
745 MHz Modulation:
780 MHz 217Hz
810 MHz **Pulse 2W 28 V/m 28 V/m
870 MHz Modulation:
930 MHz 18Hz
1720 MHz **Pulse 2W 28 V/m 28 V/m
1845 MHz Modulation:
1970 MHz 217Hz

VI-2
EMC

2450 MHz **Pulse 2W 28 V/m 28 V/m


Modulation:
217Hz
5240 MHz **Pulse 0.2 W 9 V/m 9 V/m
5500 MHz Modulation:
5785 MHz 217Hz

Note* - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while


it does not represent actual modulation, it would be worst case.
Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal.

VI-3
Appendix VII Defibrillation Monitor Shift Checklist

Please check the defibrillator monitor once a day according to the items in the list below. Check the passed
items by typing ―√‖ or ―×‖ in the ―pass/fail‖ column, indicating pass and fail respectively, and filling in ―-‖
for items not involved. If the device is found to be abnormal during the inspection process, please describe it
in the ―Exception Description‖ column.
Device name: Serial No.: Department name:
Test item Description Pass/Fail Exception
description
Device appearance Device surface is clean, with no
damage, crack and foreign matter
Battery Equipped with battery, battery
indicator is on, and battery icon shows
more than 3 grids
AC power Connect AC power, and the AC power
indicator lights up
Recording paper Recording paper is loaded and the
recording paper is sufficient
Cable and connector The cable is not damaged, and the plug
pin is not loose or bent
ECG cable and The ECG cable and electrode pads are
electrode pad complete, the cable is not damaged, the
(not used is not plug pins are not loose or bent, and the
involved) electrode pads are not expired.
Electrode pad The electrode paddle cable is not
(not used is not damaged, the plug pin is not loose or
involved) bent, and the electrode paddle is
correctly placed in the electrode paddle
slot.
Treatment cable and The treatment cable and electrode pads
electrode pad are complete, the treatment cable is not
(not used is not damaged, the plug pins are not loose or
involved) bent, and the electrode pads are not
expired.
Treatment cable shock Turn on the unit, select ―Manual
test* Defibrillation‖, connect the treatment
(not used is not cable and test the load. The charging
involved) value is 200J. Press the ―Discharge‖
button to indicate that the electric
shock is released normally. Remove
the test load after the test is complete.
Electrode paddle Turn on the unit, select "Manual
shock test** Defibrillation", connect the electrode

VII-1
Defibrillation Monitor Shift Checklist

(not used is not paddle, put the electrode paddle into


involved) the slot, charge to 10J, and press the
"Discharge" button, prompting the
electric shock to release normally.
Maintenance indicator Maintenance indicator is not lit
Tester signature: Date:

*: This check is required only if the automatic self-test or the automatic self-test fails when the treatment cable
is not used.
**: This check is required only if the automatic self-test or the automatic self-test fails when the electrode
paddle is not used.

Attention
 After the test is completed, if the test load is not removed, the patient's treatment may be
delayed.

VII-2

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