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Classic-120plus V1.2 Manual Usuario

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Patient Monitor

Classic-120plus

User Manual
(Version 1.2)

Heal Force Bio-Meditech Holdings Group


User manual for Patient Monitor

This Manual is written and compiled in accordance with the IEC 60601-1(Medical electrical equipment Part1:
General requirements for safety, and MDD 93/42/EEC. It complies with both international and enterprise
standards and is also approved by State Technological Supervision Bureau. The Manual is written for the current
Classic-120plus Patient Monitor.
The Manual describes, in accordance with the Classic-120plus Patient Monitor’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage, operation, repair,
maintenance and storage, etc. as well as the safety procedures to protect both the user and equipment. Refer to the
respective chapters for details.

The Manual is published in English and we have the ultimate right to explain the Manual. No part of this manual
may be photocopied, reproduced or translated into another language without the prior written consent. We reserve
the right to improve and amend it at any time without prior notice. Amendments will however be published in a
new edition of this manual.
All rights reserved.

Marks in the Manual:

0 Warning: must be followed to avoid endangering the operator and the patient.
☞ Note:contains some important information and tips about operations and application.
 Attention: must be followed to avoid causing damage to the monitor.

3502-3420008

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User manual for Patient Monitor

Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following very carefully
before using this equipment.
Read these instructions carefully before using this monitor. These instructions describe the
operating procedures to be followed strictly. Failure to follow these instructions can cause
monitoring abnormality, equipment damage and personal injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring
abnormality, personal injury and equipment damage due to user’s negligence of the
operation instructions. The manufacturer’s warranty service does not cover such faults.
0 WARNING-PACEMAKER PATIENTS. Rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do
not rely entirely upon rate meter ALARMS. Keep pacemaker patients under
close surveillance. See this manual for disclosure of the pacemaker pulse
rejection capability of this instrument.
0 Monitoring a single person at a time.

0 The monitor is defibrillator proof. Verify that the accessories can function
safely and normally and the monitor is grounded properly before conducting
defibrillation.

0 Disconnect the monitor and sensors before MRI scanning. Use during MRI
could cause burns or adversely affect the MRI image or the monitor’s
accuracy.

0 If you have any doubt to the grounding layout and its performance, you must
use the built-in battery to power the monitor.

0 All combinations of equipment must be in compliance with IEC Standard 60601-1-1

systems requirements.

0 Check SpO 2 probe application site periodically (every 30 minutes) to


determine circulation, positioning and skin sensitivity.

0 The SpO 2 measurement of this monitor may not work for all testees. If stable
readings can not be obtained at any time, discontinue use.
0 Do not immerse the monitor or its accessories in liquid to clean.

0 Do not use accessories other than those provided/recommended by the


manufacturer.

0 Each time the monitor is used, check the alarm limits to ensure that they are
appropriate for the patient being monitored.

0 The monitor is intended only as an adjunct in patient assessment. It must be


used in conjunction with clinical signs and symptoms.

0 When taking the measure of an infants (less than 10 years old) blood pressure, do NOT
operate in the adult mode. The high inflation pressure may cause lesion or even body
putrescence.

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User manual for Patient Monitor

0 The monitor is prohibited from applying to those who have severe hemorrhagic tendency
or who are with sickle cell disease for they may develop partial bleeding when this
monitor is used to take the blood pressure measurement.

0 DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or
intubations or skin lesion area, otherwise, damages may be caused to the limb.

0 Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with
microcirculatory problem. It is recommended that the sensor should NOT be applied to
the same place for over two hours, change the measuring site periodically if necessary.
0 SpO2 measuring position must be examined more carefully for some special patient. Do
NOT install the SpO2 sensor on the finger with edema or vulnerable tissue.

0 To prevent the risk of the short circuit and to ensure the ECG signal quality, the
equipment must be properly grounded.

0 Although biocompatibility tests have been performed on all the applied parts, some
exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who have
anaphylaxis.

0 All the connecting cables and rubber tubes of the applying parts should be kept away from
the patient’ s cervix to prevent any possible suffocation of the patient.

0 All the parts of the monitor should NOT be replaced at will. If necessary, please use the
components provided by the manufacturer or those that are of the same model and
standards as the accessories along with the monitor which are provided by the same
factory, otherwise, negative effects concerning safety and biocompatibility etc. may be
caused.

0 DO NOT stare at the infrared light of SpO2 sensor when switch it on, for the infrared may
do harm to the eye.

0 If the monitor falls off accidentally, please do NOT operate it before its safety and
technical indexes have been tested minutely and positive testing results obtained.
0 It is recommended to take the blood pressure measurement manually. The automatic or
continuous mode should be used at the presence of a doctor/nurse.

0 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2
cannula kits and on-airway adapters may compromise functionality and system
performance leading to a user or patient hazard. Performance is not guaranteed if an
item labeled as single patient use is reused.

0 Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT
use if it appears to have been damaged. Refer servicing to qualified service personnel.

0 Electrical Shock Hazard; No user serviceable parts inside the CO2 Sensor.
0 After the life cycle of the Sidestream CO2 Sensor and its accessories has been met,
disposal should be accomplished following national and/or local requirements.

0 Please peruse the relative content about the clinical restrictions and contraindication.

0 When disposing of the monitor and its accessories, the local law should be followed.

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User manual for Patient Monitor

Table of Contents
CHAPTER 1 OVERVIEW.....................................................................................................................................1
1.1 Features ...........................................................................................................................................................1
1.2 Product Name and Model................................................................................................................................2
1.3 Applications and Scope ...................................................................................................................................2
1.4 Operating Environment ...................................................................................................................................2
1.5 Impact on Environment and Resources...........................................................................................................2
1.6 Safety...............................................................................................................................................................2
CHAPTER 2 WORKING THEORIES .................................................................................................................3
2.1 Overall Structure .............................................................................................................................................3
2.2 Composition ....................................................................................................................................................3
2.3 Working Theories ............................................................................................................................................3
CHAPTER 3 INSTALLATION AND CONNECTION........................................................................................5
3.1 Installation.......................................................................................................................................................5
3.1.1 Opening the Box and Check .....................................................................................................................5
3.1.2 Connecting the AC Power Cable..............................................................................................................5
3.1.3 Starting the Monitor .................................................................................................................................5
3.2 Appearance ......................................................................................................................................................6
3.2.1 Front Panel...............................................................................................................................................6
3.2.2 Left and Right Panel.................................................................................................................................7
3.2.3 Rear Panel................................................................................................................................................8
3.3 Connection ......................................................................................................................................................9
3.3.1 ECG Connection ......................................................................................................................................9
3.3.2 Blood Pressure Cuff Connection ............................................................................................................11
3.3.3 SpO2 Probe Connection..........................................................................................................................13
3.3.4 TEMP Probe Connection........................................................................................................................15
3.3.5 Loading Printing Paper..........................................................................................................................15
CHAPTER 4 MONITORING SCREEN .............................................................................................................17
4.1 Main Screen...................................................................................................................................................17
4.1.1 Date and Time Setup...............................................................................................................................17
4.1.2 Main Screen............................................................................................................................................18
4.2 Monitoring Screen.........................................................................................................................................21
4.2.1 Viewing Screen .......................................................................................................................................21
4.2.2 Seven ECG Waveforms on the Same Screen ...........................................................................................22
4.2.3 Five Channels Real-time Waveforms and Trends on the Same Screen ...................................................23
4.3 Freeze and ST Analysis Screen .....................................................................................................................24
4.4 Mode Selection Screen..................................................................................................................................25
4.4.1 SpO2 Data List Screen ............................................................................................................................25
4.4.2 Blood Pressure Data List Screen............................................................................................................26
4.4.3 Graphic Trend Screen.............................................................................................................................26
4.4.4 Recall Screen ..........................................................................................................................................30
4.4.5 VPC Screen.............................................................................................................................................32
4.4.6 System Setup Screen ...............................................................................................................................33
4.4.7 Color Settings screen..............................................................................................................................37
4.4.8 File/Archive Management Screen...........................................................................................................38
4.4.9 oxyCRG Screen.......................................................................................................................................39
4.4.10 Event List Screen ..................................................................................................................................39
4.4.11 MC Calculator......................................................................................................................................40
CHAPTER 5 CO2 MONITORING......................................................................................................................42
5.1 CO2 Parameter Settings .................................................................................................................................42

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User manual for Patient Monitor

5.2 CO2 Sensor Connection.................................................................................................................................43


5.2.1 Sidestream CO2 Sensor Connection .......................................................................................................43
5.2.2 Mainstream CO2 Sensor Connection......................................................................................................45
5.3 CO2 Monitoring Screen .................................................................................................................................47
5.4 CO2 Graphic Trend........................................................................................................................................48
CHAPTER 6 ALARM ..........................................................................................................................................49
6.1 Alarm Priority................................................................................................................................................49
6.2 Alarm modes .................................................................................................................................................50
6.3 Alarm Silence ................................................................................................................................................50
6.4 Alarm Setting.................................................................................................................................................50
6.5 Verify Adjustable Alarm Function.................................................................................................................51
CHAPTER 7 TECHNICAL SPECIFICATIONS ...............................................................................................52
7.1 ECG Monitoring............................................................................................................................................52
7.2 RESP Monitoring ..........................................................................................................................................53
7.3 TEMP Monitoring .........................................................................................................................................53
7.4 NIBP Monitoring...........................................................................................................................................53
7.5 SpO2 Monitoring............................................................................................................................................54
7.6 Pulse Monitoring ...........................................................................................................................................54
7.7 CO2 Monitoring.............................................................................................................................................54
7.8 Data Recording..............................................................................................................................................55
7.9 Other Technical Specifications......................................................................................................................55
7.10 Classification...............................................................................................................................................55
7.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility..................................................56
CHAPTER 8 PACKAGING AND ACCESSORIES...........................................................................................60
8.1 Packaging ......................................................................................................................................................60
8.2 Accessories ....................................................................................................................................................60
CHAPTER 9 PARAMETERS MONITORING .................................................................................................61
9.1 ECG Monitoring............................................................................................................................................61
9.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value.......................................................61
9.1.2 Factors affecting ECG signal.................................................................................................................61
9.2 NIBP Monitoring...........................................................................................................................................62
9.2.1 Measuring Principle...............................................................................................................................62
9.2.2 Factors affecting NIBP measuring .........................................................................................................63
9.2.3 Clinical Limitations................................................................................................................................64
9.3 SpO2 Monitoring ...........................................................................................................................................65
9.3.1 Measuring Principle...............................................................................................................................65
9.3.2 SpO2 Measurement Restrictions (interference reason)...........................................................................65
9.4 Respiration Monitoring .................................................................................................................................66
9.4.1 Measuring Principle...............................................................................................................................66
9.4.2 Factors affecting respiration monitoring ...............................................................................................66
9.5 Temperature Monitoring................................................................................................................................66
9.6 CO2 Monitoring.............................................................................................................................................67
9.6.1 Measuring Principle...............................................................................................................................67
9.6.2 Mainstream vs. Sidestream Sampling.....................................................................................................67
CHAPTER 10 TROUBLESHOOTING ..............................................................................................................68
10.1 No Display on the Screen............................................................................................................................68
10.2 Excessive ECG Signal Interference or too Thick Baseline .........................................................................68
10.3 No Blood Pressure and Pulse Oxygen Measures.........................................................................................68
10.4 System Alarm ..............................................................................................................................................68

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User manual for Patient Monitor

CHAPTER 11 MAINTENANCE .........................................................................................................................69


11.1 Service and Examination.............................................................................................................................69
11.1.1 Daily Examination ................................................................................................................................69
11.1.2 Routine Maintenance ............................................................................................................................69
11.2 Battery Maintenance....................................................................................................................................69
11.3 Cleaning, Sterilization and Disinfection......................................................................................................70
11.4 Cleaning, Sterilization and Disinfection of Accessories..............................................................................71
11.5 Storage.........................................................................................................................................................71
11.6 Transportation..............................................................................................................................................71
CHAPTER 12 APPENDIX ...................................................................................................................................72
12.1 Alarm Information.......................................................................................................................................72
12.2 Default Alarming Values and Setup Range .................................................................................................73
12.3 Abbreviation of Arrhythmia ........................................................................................................................75
12.4 Status/Error during NIBP Monitoring .........................................................................................................76
12.5 Status/Error during CO2 Monitoring ...........................................................................................................77
12.6 Typical Pressures and CO2 Readings at Altitudes .......................................................................................78
12.7 Accessories List...........................................................................................................................................79
12.8 Instructions for SpO2 Probe.........................................................................................................................80

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User manual for Patient Monitor

Chapter 1 Overview
1.1 Features
This monitoring system can be used to monitor patient’s physiological parameters: ECG, respiratory rate,
body temperatures, non-invasive blood pressure (NIBP), EtCO2, pulse oxygen saturation (SpO2), and
pulse rate.
— 12.1″ high-resolution (800 × 600) TFT color LCD to display of patient’s ECG waveform,
respiratory waveform, SpO2 waveform and CO2 waveform;
— Abundant and friendly display interface, multifold ECG display screen:
Main monitoring screen: displays the information of all the waveforms and parameters visually.
Observing screen: heart rate value and SPO2 value display in big fonts.
Seven lead waveforms on one screen: displays the information of 7 ECG lead waveforms and
different monitoring parameters on one screen.
Eight channel real-time waveforms and two hours’ trends viewing: intuitionistic knowing the
physiological status of patient.
— Real-time monitoring of battery capacity, when the battery power is insufficient, low battery
voltage alarm indication will display on LCD screen;
— Automatic analysis of 21 arrhythmia waveforms and arrhythmia, waveform freezing function
and automated ST segment measurement and manual analysis;
— Up to 480 hours statistic data of HR, TEMP, SpO2, RESP and NIBP trends;
— 100 groups of arrhythmia cases’ data and the corresponding lead, gain and filter mode of ECG;
— Storage and recall of a list of 800 groups of NIBP measurement data, as well as heart rate, body
temperature, respiratory rate and SpO2/pulse rate when the measure of blood pressure is taken;
— 24 hours of ECG data storage and recall;
— High precision NIBP measuring module;
— Special SpO2 measuring device, which ensures the accuracy of SpO2 and pulse rate measures;
— Flexible high and low alarm limits setting function;
— Easy to color-code and change the color of the font, background and waveforms if need be;
— Resistance against defibrillator and electrosurgical unit interference, and high safety level;
— Able to be used along with cardiac pacemaker;
— Built-in battery supports up to 2 hours of continuous operation;
— Blood pressure may be measured in the mode of “adult/infant /neonate”, which may be selected
via the menu, to better suit the adult, infant or newborn patient;
— The monitor is equipped with built-in thermal printer (optional), which can be used to output
waveform, character information conveniently.
— CO2 monitoring and IBP monitoring are optional functions;
— Networking with the central station as a part of the central network.

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User manual for Patient Monitor

1.2 Product Name and Model


Name: Patient Monitor
Model: Classic-120plus

1.3 Applications and Scope


This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and
pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate,
non-invasive blood pressure, functional oxygen saturation, end-tidal CO2 concentration, respiration rate, body
temperature, and so on, it allows comprehensive analysis of patient’s physiological conditions.
This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by
qualified professionals only.

1.4 Operating Environment


1. Ambient temperature range: 5℃~40℃
Relative humidity: 30%~80%
Atmospheric pressure: 70kPa ~106.0kPa
Power Voltage: 100V-240V AC
Power frequency: 50/60 Hz
2. This equipment should be situated in a place protected against direct sunlight, so as to prevent overheating
inside the equipment.
3. Do not use this equipment in an environment with toxic or inflammable gas.
4. This equipment should be placed on a stand or flat platforms, so as to prevent possible shock.
5. Do not use this equipment in combination with any equipment other than those expressly permitted in the
manual.
6. When using this device with electrosurgical equipment, the user (doctor or nurse) should pay attention to the
safety of patient.
7. Make sure that the equipotential grounding terminal is grounded correctly.
8. Do not use mobile phone nearby, so as to avoid strong radiant field interference.

1.5 Impact on Environment and Resources


Low

1.6 Safety
a) This device conforms to IEC60601-1, electric safety classicfication: Class I, with Type BF and CF applied
parts.
b) This device can resist against the discharge of defibrillator and the interference of eletro-surgical unit.
c) This device can monitor the patients with pace-maker.
d) DO NOT use this device while the patient is under MRI scanning.

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User manual for Patient Monitor

Chapter 2 Working Theories


2.1 Overall Structure
The overall structure of the monitor is shown as Figure 2.1

Figure 2.1

2.2 Composition
1. The monitor consists of the main units and the corresponding functional components (ECG leads, non-invasive
blood pressure cuff, SpO2 probe, temperature transducer, appendix of invasive blood pressure and side-stream
CO2).
2. The patient monitor has 6 measurement channels: the ECG and respiration channel, the NIBP channel, the SpO2,
pulse channel, the temperature channel, and EtCO2, InsCO2 channel.
3. The patient monitor has two output channels: the networking communication port and the printer.
4. Basic parameters include: heart rate, respiration rate, EtCO2, InsCO2, temperature, SpO2, NIBP (diastolic,
systolic and MAP) and pulse.

2.3 Working Theories


Classic-120plus Patient Monitor, which performs physiological parameter measurement through different modules, is a
product of module design. It consists of six modules: ECG module, NIBP module, SpO2 module, IBP module (optional),
CO2 module (optional) and the main unit.
1. The ECG module collects the heart rate, respiration waveforms through the ECG leads & electrodes and collects
the temperature data through the temperature probes as well.

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User manual for Patient Monitor

2. The SpO2 module collects the data of pulse rate, pulse oxygen saturation (SpO2) and SpO2 volume waveform via
the SpO2 probe.
3. The NIBP module collects the blood pressure data, including the diastolic, systolic and mean arterial pressure
through the NIBP cuff. The cuffs are designed for adult, infant and neonate respectively, and the NIBP
measurement has three modes: adult, infant and neonate.
4. The CO2 module collects the date of respiration rate, EtCO2, InsCO2 through the sampling tube.
5. The main unit consists of main board, multi-function board, and the keyboard. The multi-function board performs
the data communication among the main board, ECG module, SpO2 module, NIBP module, IBP module(optional),
and CO2 module(optional).

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User manual for Patient Monitor

Chapter 3 Installation and Connection


3.1 Installation
3.1.1 Opening the Box and Check
1. Open the package, take out the monitor accessories from the box carefully and place it in a safe stable and easy to
watch position.
2. Open the user manual to sort the accessories according to the packing list.
‹ Inspect the accessories for any mechanical damages
‹ Check all the exposed leads and inserted accessories
☞ You can customize the module configuration by choosing necessary modules to meet your own needs.
Therefore, your monitor may not have all the monitoring functions and accessories.
Please contact the local dealer or our company in case of any problems. We will offer the best solution for your
satisfaction.

3.1.2 Connecting the AC Power Cable


1. When powered by AC mains power supply:
‹ Make sure that the AC power supply is 100-240VAC, 50/60Hz.
‹ Use the power cable prepared by the manufacturer. Insert one end of it to the power port of the monitor
and the other end to the grounded three-phase power jack.
‹ To eliminate potential differences, the monitor has a separate connection to the equipotential grounding
system. Connect one end of the provided ground cable to equipotential grounding port on the rear of the
monitor, and connect the other end to one point of the equipotential grounding system.
Caution: ensure that the monitor is grounded correctly.
 After the supply mains has been interrupted when power switch remains in the “on” position and is restored
after a period of time that is longer than 30 seconds, the monitor will run by the last settings when restarting
the monitor.
2. When powered by built-in battery
‹ Caution: it’s better to recharge the battery after it is used up, and the charging time should be 13~15
hours long.
 The provided battery of the monitor must be recharged after transportation or storage. So if the monitor is
switch on without being connected to the AC power socket, it may not work properly due to insufficient power
supply.

3.1.3 Starting the Monitor


The system performs self-test and enters initial display after switch on the monitor, and the alarm rings to inform
that the user can begin operating it.
‹ Check all the applicable functions to make sure that the monitor works normally.
‹ If the built-in battery is applied, please recharge it after using the monitor to ensure sufficient power
storage. It will take at least 8 hours to charge battery from depletion to 90% charge.
0 Do not use the monitor to monitor the patient if there are indications of damage or reminders of error. Please
contact the local dealer or our company.
0 Start the monitor again 1 minute later after it is switched off.

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User manual for Patient Monitor

3.2 Appearance
3.2.1 Front Panel

Figure 3.1 Front Panel


1. Power switch: Press it to switch on/ off the monitor.
2. AC power indicator: When AC indicator is on, it means this device is using mains power supply.
3. DC power indicator of built-in battery:
When DC indicator is on, it means the battery is used; when both of AC indicator and DC indicator are on, it
means that this device is using mains power supply and the battery is being recharged.

4. ECG lead selection: Click it to shift the ECG monitoring circulatory among Ⅰ, Ⅱ, and Ⅲ, AVR, AVL,
AVF and V.

5. Alarm silence: Press this key to set or activate the system alarm. In the monitoring screen, press
“Alarm” to set the alarm timer. The time shows up on the upper left corner of the screen. When the alarm
timer is activated, the system begins to count down and alarm when the set time has passed. There are four
options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and 20 minutes.
0 DO NOT silence the audible alarm or decrease its volume or patient
safety could be compromised.

6. Freeze: Press the key to freeze ECG waveform or the waveforms of ECG, SpO2 and RESP for the S-T
segment analysis according to the system setting.

7. NIBP: Press it to start or stop NIBP measuring.

8. Print: Click it to print out different waveforms under different system states.

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User manual for Patient Monitor

9. DISP: Click it to shift the display modes. Press it to shift the main screen, list screen, viewing screen and
the seven leads on the same screen and return to the main screen from other screens.

10. Navigation Knob: It is the major operating key of the system, which can be used to select functions or
parameters. Press and release it to shift the screen and to confirm the function or other operating tips.
11. Alarm indicator:

Indicator Color Alarm Level Alarm Event


Red flashing High priority alarm Exceeding the limits, pulse stop or suffocation
Orange flashing Medium priority alarm Leads and probe off, VE RONT and SVE RONT
Orange light Low priority alarm Other arrhythmia phenomenon
Green light Normal

3.2.2 Left and Right Panel

Figure 3.2 the left panel Figure 3.3 the right panel
Different ports are located in different positions of the monitor for operating conveniences.
The built-in printer is at the left panel, shown in Figure 3.2.
The cable and probe ports are at the right panel, shown in Figure 3.3.
1. TEMP1, TEMP2: TEMP probe connector
2. NIBP: NIBP hose connector
3. SpO2: SpO2 probe connector
4. ECG/RESP: ECG cable connector
5. CO2: Cable connector of CO2 sensor module
6. : the cover of battery compartment, open it to replace or insert the battery. The provided standard battery
is a piece of 12V and 2.3Ah rechargeable battery. (The back-up rechargeable battery is optional, and the
detailed type of the battery you can see the surface of it.)
Note: Only the battery of same model with the standard battery can be used. Insert battery properly, or else the
improper insertion may damage the monitor.

With type BF applied parts

With type CF applied part and applicable during the defibrillator is used.

Caution! Please read the manual for details.

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User manual for Patient Monitor

3.2.3 Rear Panel

Figure 3.4 Rear panel


The following ports are at the rear panel of the monitor.
(1) Monitor: External display port
(2) NET: Serial communication port which is used to network with central monitoring system

(3) : Equipotential grounding port


(4) Fuse 2¯T3. 15A: Fuse holders, fuse specification: T3. 15AL/250V Φ5¯20mm.
(5) 100~240VAC: Power supply socket
(6) S/N: Serial Number
(7) Nameplate

CE mark

Serial number

Authorised representative in the European community

Disposal of this device according to WEEE regulations

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User manual for Patient Monitor

3.3 Connection
3.3.1 ECG Connection

ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and the lead. The
lead connects the monitor. The locations of the electrodes are very important for obtaining accurate ECG signals.
1. Connect the cable to the right-panel connector marked with the ECG icon.
2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid variations in electrical
resistance. For ECG monitoring, it is strongly recommended to use silver/silver chloride electrodes. When
dissimilar metals are used for different electrodes, the electrodes may be subject to large offset potentials due to
polarization. Using dissimilar metals may also increase recovery time after defibrillation.
3. Prepare the electrode sites according to the electrode manufacture’s instructions.

4. Skin clean
¾ Clean and dry-abrade skin to ensure low sensor impedance. Mild soap and Water is recommended as a skin
cleanser.
Note: Alcohol is not recommended as a skin cleanser; for it leaves a film layer that may cause high sensor
impedance. If alcohol is used, ensure 30-second dry time.

¾ Dry-abrading the skin gently with a dry wash cloth, gauze, for skin preparation is helpful to remove the
non-conductive skin layer.

The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator-proof.
The locations of the electrode are in the following Figure:

Figure 3.5 Electrode Location


Note: If skin rash or other unusual symptoms develop, remove electrodes from patient.

5. After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system will
display “LEAD OFF” on the screen to alarm the operator.
 It might not display ECG wave with 3 leads. The 5 leads should be used to have ECG wave.

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User manual for Patient Monitor

6. The ECG leads and their corresponding locations are as follows:


Symbol Position
The intersection between the centerline of the right
RA
clavicle and Rib 2
The intersection between the centerline of the left clavicle
LA
and Rib 2
LL Left part of the upper abdomen
RL Right part of the upper abdomen
C1(V1)
C (V) C2(V2)
C3 (V3) The electrodes are placed in different places, the different
Chest C4 (V4) lead forms will display.
electrode C5 (V5)
C6 (V6)
Safety Instructions for ECG Monitoring
 Patient Monitor can only be equipped with ECG leads provided by our company; using ECG leads supplied
by other companies may cause improper performance or poor protection while using defibrillator.

 Electric parts of electrodes, leads and cable are forbidden to contact any other conductive parts (including
ground).

 Patient Monitor can resist against defibrillator and electrosurgical unit. Readings may be inaccurate for a short
time after or during using defibrillator or electrosurgical unit.

 Transient caused by cable circuitry blocks while monitoring may be similar to the real heartbeat waveform, as
a result resistance heart rate alarm rings. If you put the electrodes and cable in proper places according to this
manual’s instructions and the instructions for using electrode, the chance of this transient occurring will be
decreased.

0 To the patient with pacemaker, due to that this device has been designed to provide resistance to pacemaker
signal interference, generally the pacemaker pulse is not counted in heart rate measurement and calculation,
but when the cycle time of pacemaker pulse is over 2ms, it may be counted. In order to reduce this possibility,
observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart rate display and
alarm system of this monitor when monitoring this kind of patients. Keep pacemaker patient under close
surveillance.

0 Besides the improper connection with electrosurgical unit may cause burns, the monitor may be damaged or
arouse deviations of measurement. You can take some steps to avoid this situation, such as do NOT use small
ECG electrodes, choosing the position which is far away from the estimated Hertzian waves route, using larger
electrosurgical return electrodes and connecting with the patient properly.

0 No predictable hazard will be caused by the summation of leakage currents when several item of monitor are
interconnected.

 ECG leads may be damaged while using defibrillator. If the leads are used again, please do the functional
check first.

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User manual for Patient Monitor

3.3.2 Blood Pressure Cuff Connection

1. Connect the cable to the right-panel connector marked with the NIBP icon.
2. Unveil and wrap the cuff around patient’s upper arm.
Requirements of the cuff:
1) Appropriate cuff should be selected according to the age of the subject. Its width should be 2/3 of the length of
the upper arm. The cuff inflation part should be long enough to permit wrapping 50-80% of the limb concerned.
See the table below for the dimensions:

Note: The size of the cuff selected should suit the subjects while measuring.
Cuff Model Arm Circumference Cuff Width
Neonate Cuff 6.0cm~9.5cm 3cm
Small-sized Pediatric Cuff 6cm~11cm 4.5cm
Middle-sized Pediatric Cuff 10cm~19cm 8cm
Large-sized Pediatric Cuff 18cm~26cm 10.6cm
Adult Cuff 25cm~35cm 14cm

2) When putting on the cuff, unveil and wrap it around the upper arm evenly to appropriate tightness.
3) Remember to empty the residual air in the cuff before the measurement is commenced.
4) Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery is
observed.
5) The cuff should be tightened to a degree where insertion of one finger is allowed.
6) The lower end of the cuff should be 2cm above the elbow joint.

Figure 3.6 Cuff Position

The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator proof.
¾ Pressure Accuracy Verification
Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP module
inside the device. Technician or equipment manager should do pressure accuracy verification every half year or
year in order to check if the pressure measurement still conforms to the requirement of product performance. If
the deviation is beyond the declared specification, it is permitted to return it to factory for repair or calibration.
Before verification, please connect the monitor to a standard pressure meter as the reference
equipment like a mercury pressure meter

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Figure 3.7 Connection of Pressure calibration fixture

Mode 1: The inflation can be activated by Monitor so the pressure will increase automatically untill it
exceeds the limit value specified in table A. This pressure limit value depends on the patient type selection as
shown in table A:

Adult 240mmHg

Child 200mmHg

Neonate 120mmHg
Table A
During the inflation, the Monitor will close the deflating valve, and the pressure value will be shown during
the process. If there is no manual deflation operation, the pressure will persist untill deflation by manual
operation, so it is necessary to use a manual valve for doing adequate deflation in several steps to verify the
pressure accuracy in the full scale of measurement range.
Mode 2: No automatic inflation by Monitor during the pressure accuracy verification.
Increase the pressure manually by the pumping balloon, and the verification can be done by applying different
pressure value manually. If the increased pressure exceeds the given limit as shown in table B, the Monitor will
deflate automatically because of over-pressure protection.

Adult 300mmHg

Child 240mmHg

Neonate 140mmHg
Table B
 After the verification, do press the button again to return to normal working mode, then continue other
operation, or the NIBP key will be invalid.
 Pressure accuracy verification must be operated by technician or equipment manager. Doctor or nurse
is not allowed to do the verification, it is very dangerous especially when the pressure cuff is still on
patients.
¾ Air Leakage Check
In order to avoid significant error of blood pressure measurement or even no measurement result caused by air
leakage in the pneumatic system including the cuff during measuring, it is recommended to check if there is leak in
the pneumatic system as well.
 Please remove the cuff from patient while performing the leakage check.

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Safety Instructions for NIBP Measurement


0 When taking the measure of an infant or neonate’s (less than 10 years old) blood pressure, do NOT
operate in the adult mode. The high inflation pressure may cause lesion or even body putrescence.
0 It is recommended to take the blood pressure measurement manually. Automatic or continuous
measurement should be used at the presence of a doctor/nurse.
0 NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell
disease, or partial bleeding will appear.
0 Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area, otherwise,
damages may be caused to the limbs.
0 Pay attention to the color and sensitivity of the limb when measuring NIBP; make sure the blood
circulation is not blocked. If blocked, the limb will discolor, please stop measuring or remove the cuff
to other positions. Doctor should examine this timely.
0 The time of the automatic pattern noninvasive blood pressure measurement pull too long, then the
body connected with the cuff possibly have the purpura, lack the blood and the neuralgia. When
guarding patient, must inspect the luster, the warmth and the sensitivity of the body far-end frequently.
Once observes any exception, please immediately stop the blood pressure measurement.
 The subject should lie on the back so that the cuff and the heart are in a horizontal position and the
most accurate measure is taken. Other postures may lead to inaccurate measurement.
 Do not speak or move before or during the measurement. Care should be taken so that the cuff will not
be hit or touched by other objects.
 The measurements should be taken at appropriate intervals. Continuous measurement at too short
intervals may lead to pressed arm, reduced blood flow and lower blood pressure, and resulting
inaccurate measure of blood pressure. It is recommended the measure be taken at intervals of more
than two minutes.
 When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the
infant mode is selected.
 Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate
measurement.
 Do NOT twist the cuff tube or put heavy things on it.
 When unplugging the cuff, hold the head of the connector and pull it out.

The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator proof.

3.3.3 SpO2 Probe Connection

SpO2 probe is very delicate equipment. Please follow the steps and procedures in operating it. Failure to operate it
correctly can cause damage to the SpO2 probe.
Operation procedure:
1. Connect the SpO2 probe to the right panel’s jack labeled “SpO2”. When unplugging the probe, be sure to
hold the head of the connector and pull it out.

2. Insert one finger into the probe (index finger, middle finger or ring finger with proper nail length)
according to the finger mark on the probe, shown as below.

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Figure 3.8 Demonstration of SpO2 Probe


When selecting a sensor, do consider the patient’s category, adequacy of perfusion, availability of probe site and
anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor. Read the following
table for SpO2 probe information. Refer to Chapter 12.8 for the detailed instructions of each SpO2 probe.

SpO2 Probe Patient Category


SpO2 Finger clip Sensor (reusable) Pediatric
SpO2 Finger rubber Sensor(reusable) Adult
SpO2 Finger clip Sensor(reusable) Adult

High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of an SpO2 sensor. To
prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque
material.

Failure to take this action in high ambient light conditions may result in inaccurate measurements.

If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less
active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive backing.

For reusable sensors, follow the sensor directions for use for cleaning and reuse. For single-patient use sensors, use a
new sensor for each patient. Do not sterilize any sensor by irradiation, steam, or ethylene oxide.

Safety Introductions for SpO2 Monitoring


0 Continuous use of fingertip SpO2 sensor may result in discomfort or pain, especially for
those patients with microcirculatory problem. It is recommended that the sensor should
NOT be applied to the same finger for over two hours, change the measuring site
periodically if necessary.
0 SpO2 measuring position must be examined more carefully for some special patient. Do
NOT install the SpO2 sensor on the finger with edema or fragile tissue.
0 Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP
measuring will affect SpO2 measuring and cause the alarm error.
 If sterile packaging of SpO2 sensor is damaged, do not use it any more.
 Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor.
 When the temperature of SpO2 sensor is abnormal, do not use it any more.
 Please do not allow the cable to be twisted or bended.
 Please do not use nail polisher or other cosmetic product on the nail.
 The fingernail should be of normal length.
 The SpO2 sensor can not be immerged into water, liquor or cleanser completely, because the sensor has no
capability of waterproofness.

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3.3.4 TEMP Probe Connection

Patient Monitor has two TEMP probes to measure different body temperature.

Connecting methods:

1. Attach the probes to the patient firmly;


2. Connect them to “TEMP” on the right panel.
Note: When unplugging the probe, be sure to hold the head of the connector and pull it out.

3.3.5 Loading Printing Paper

This description is for loading paper for the built-in printer.


Operation procedures:
1. Press both “OPEN” notches with force on printer shield with two thumbs to open it.
2. Move the tab of rubber roller lock at the left 90°upwards to unlock it.
3. Cut one end of the paper into triangle, and load the paper from the underside of the rubber roller.
4. Turn the roller clockwise to get the paper rolled, and put the paper roll into the compartment.
5. Pull the paper out of paper slot on the shield.
6. Move the tab of the rubber roller lock 90° downwards to lock it.
7. Put the shield back in position and secure it.
Unloading printing paper
1. Press both “OPEN” notches vertically with force on printer shield with two fingers to open it.
2. Move the tab of roller lock at the left 90° upwards to unlock it.
3. Roll the loading roller anti-clockwise and pull the paper out.
4. Roll the loading roller clockwise to get the paper rolled, and put it into the compartment.
5. Pull the paper out of paper slot on the shield.

Fig.3.9 Fig.3.10

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P8 printer may be used due to the different configuration.


P8 printer operation instruction:
Power indicator: green light shows the power is on, while the monitor is out of power, the green light is off.
Error indicator: red light is constant which shows the printer is out of paper, or the printing paper does not install well.
When the printer installs normally, the red light is off.

Power Indicator
Open button
Error Indicator

Paper cartridge

Figure 3.11 P8 printer


Loading printing paper:
Step 1: press and hold down the cartridge button to open the paper cartridge;
Step 2: Install the paper to the printer properly, pull the paper out of the printer for 2 cm, as shown in figure 3.12.
Step 3: Close the printer cover along the direction of arrow, as shown in figure 3.12.

Figure 3.12 printing paper

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Chapter 4 Monitoring Screen


4.1 Main Screen
4.1.1 Date and Time Setup
Instead of entering into monitoring screen, it shows the date and time setting screen immediately after the monitor is
started, shown as Figure 4.1:

Figure 4.1 Date and Time Setup


The system will stay on this screen for 10 seconds. If you do not rotate the navigation knob within this period, the screen
will enter into the Main Screen.
Follow the steps below to set date and time.
Step 1: Rotate Navigation Knob, move the gray cursor to “Edit”.
Step 2: Press the knob, and then “Edit” turns into “Save”. The gray cursor stays on the Year of the date. Press
the knob again and the gray cursor becomes highlighted. Rotate the knob left or right to increase or decrease
the year value.
Step 3: When the Year is set, press the knob to move the gray cursor to the Month of the date.
Step 4: Repeat Step 2 and Step 3 to adjust the Year, Month, Date, Hour and Minute.
Step 5: If you have finished adjusting the date and time, press the knob and rotate the knob to move the cursor
to “Save”. Press it to save the settings and exit the date and time setting screen, meanwhile enter into the main
screen shown in Figure 4.2. If you press “Exit”, the settings will not be saved.
The system is initialized and enters into Main Screen where monitoring and system operation are performed. (shown in
Figure 4.2)

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4.1.2 Main Screen

Figure 4.2 Main Screen


Border area
— “Alarm ”: “ ” shows the alarm stays in alarm silence status, “ ” shows the alarm is ON. “19:19”
after “ ” is the counting down time. The alarm activates automatically after the system finishes counting
down.
— “ADUL”: The type of the monitor subject. There are three modes available: “Adult”, “Infant” and
“Neonate” (Adult for adult patient, Infant for pediatric patient, Neonate for neonate patient).
— “MON”: ECG Filter type. There are “Diagnosis”, “Monitor”, and “Operation” three types. The option can
be set in the system menu.
— : battery power indicator; when the indicator is yellow and displays only one “grid”, it means there
is a little battery power left. When the indicator turns red and blinks, as well as less than one “grid”
displayed, meanwhile, the system alarm will be on to remind the battery shortage. Please connect the device
to the mains power supply in time to ensure the normal use of this monitor, and the battery will be recharged.
When the battery power is full, battery power indicator displays full grid. During recharging, the grids in the
battery indicator are rolling circularly.
— “2010-01-20 21:16:15”: System current time and date. The system time and date can be set during the
system start-up when the screen displays the time and data setups. The current figure shows the time and
date of January 20, 17:28:34, 2010.
— “Push Knob for system menu”: System prompt or description for the current status.
— “ID”: The patient ID. The patient ID can be entered or changed in the archive management window.

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Waveform area
— 1st Waveform: The first waveform is ECG waveform for lead II. The left side of the ECG shows the
marker I, which indicates the ECG scale. The scale marker changes its length according to the ECG gains.
All ECG waveforms have their own scale. When the third measured waveform change to lead II, the
waveform automatically changes to lead I.
— 2nd Waveform: The second waveform is for the ECG waveform of lead III. When the third measured
waveform displays the ECG for the lead III, this waveform automatically changes to the ECG for lead I.
— 3rd waveform: The third waveform is the measurable ECG channel. Its lead can be adjusted and will no
overlap the 1st and 2nd waveforms.
— 4th waveform: SpO2 waveform
— 7th waveform: CO2 waveform. It can be respiration waveform or CO2 waveform.

Data area

Figure 4.3 Heart Rate and Temperature Data Area


— “HR”: The currently displayed heart rate. The 60 on the right side is the heart rate measured.
— “bpm”: The heart rate unit. Bpm = beat per minute.
— “ ”:The heart beating symbol. Its flashing corresponds to the R wave of the ECG waveform. The speed
is the same with the heart rate.
— “ST+0.039mv”: The measured milli-volts value during ST measurement.
— “X1”: ECG waveform gain (amplification), 5 options available.
“Auto”: Automatic waveform gain.
“x1/2”: half size of the basic waveform
“x1”: Basic waveform
“x2” : Twice the size of the basic waveform
“x4” : Four times the size of the basic waveform
— TEMP1/2: Temperature label. The value below “36.6, 37.0” are the temperature values.
— “℃”: Body temperature unit.℃ is Celsius; and °F is Fahrenheit.
— TD: the absolute value in temperature between TEMPⅠ and TEMPⅡ.

Figure 4.4 Blood Pressure Data Area

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— “NIBP”: The blood pressure type labels and the measured value.
— “mmHg”: NIBP unit
— “17:28”: The time of NIBP measuring
— “ADUL”: NIBP measurement mode. The subject is adult.
— “kPa”: The measurement value when the unit is kPa.
The 3 values from left to right are the blood pressure: Systolic pressure value (“127”), Diastolic pressure
value (“85”) and MAP (“98”).
— “MANU”: The NIBP measurement mode.

Figure 4.5 SpO2 and Pulse Rate Data Area


— “SpO2”: SpO2 label,The “99” on the right side is the current SpO2 value measured.
— “PR”: Pulse rate label. The value “62” on the lower left shows the pulse rate value.

— “ ”: SpO2 strength bar.

Figure 4.6 RR, EtCO2, and Ins Data Area


— “RR”: Respiration Rate: The rpm after that is the unit of the respiration, i.e., respiration per min.
— “EtCO2 39.0”: The label and the value will become gray when CO2 is turned off.
— Ins: The label of the minimal inhalational CO2, the label and the value will become gray when CO2 is turned
off.
— “16”: Respiration rate. It will display the respiration rate of CO2, when the switch is turned on.
— “X1”: Respiration gain(amplification) :
“X1/2” half of the basic waveform
“X1” basic waveform
“X2” Twice the size of the basic waveform.
“X4” 4 times of the basic waveform
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

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4.2 Monitoring Screen


4.2.1 Viewing Screen
Choose Obsev of Disp2 on system setup screen, press the DISP key to enter the monitoring screen, as shown in
Figure 4.7.

Figure 4.7 Monitoring Screen

In this screen, press the DISP key to switch the ECG lead, or press the Print key to print the ECG waveform and the
second waveform. The second waveform can be selected in the System menu.

☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

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4.2.2 Seven ECG Waveforms on the Same Screen


Choose 7 ECG of Disp2 on system setup screen, press the DISP key, the system enters the 7 ECG waveform screen.
In this screen, the operator can simultaneously view the ECG waveform for 7 leads: I, II, III, AVR, AVL, AVF and V, as
shown in 4.8.

Figure 4.8 7 Leads on the Same Screen


In this screen, rotate the Navigation Knob to adjust the ECG gain. The ECG gain includes 5 options: “Auto”, “X1/2”,
“X1”, “X2”, “X4”. Rotate the knob to adjust the gain for all 7 ECG waveforms. Press (Freeze) button to freeze all 7
ECG waveforms.
Operating Instructions
In the above 3 monitoring screens, the operator can perform normal printing and the blood pressure measurement. The
printing cannot be performed during the blood pressure measurement. When pressing the (Display) key again on the
front panel, the system returns to the main screen.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

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4.2.3 Five Channels Real-time Waveforms and Trends on the Same Screen
When the Disp2 option is “Trend” on system menu screen, press the DISP key on the main screen, the system will enter
the trend screen, as shown in Figure 4.9. Five channel real-time waveforms and trend graph can be viewed on this
screen.

Figure 4.9 Five Channel Real-time Waveforms and Two Hours Trends

Operating Instructions
In the above monitoring screens, the operator can perform freeze, normal print and the blood pressure etc. measurement,
in addition, print and blood pressure measurement can be operated at the same time. When pressing the “DISP” key
again on the front panel, the system returns to the main screen.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

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4.3 Freeze and ST Analysis Screen


During the process of monitoring the patient, the healthcare provider can freeze the screen to perform detailed analysis.
If necessary, the operator can send one of the frozen waveform to the printer.

In the main screen, press the (Freeze) key to freeze the 3 ECG waveforms or all the waveforms on the screen, as
shown in Figure 4.10.

Figure 4.10 Frozen Screen


Screen Description

Freezing, ST segment analysis screen is similar with the main screen, except the waveforms are frozen. For example, the
figure below is a portion of the frozen waveform from the 3rd ECG waveforms. The symbols on the screen were
described briefly on the screen.

 When the system setting for the freezing waveform is “ALL”, the (Freeze) key will freeze all the
waveforms.

Operating Instructions
The operation can use the Navigation Knob to analyze the ST segment waveform, i.e. measuring the difference between
the ST segment value and the referenced value. The value is displayed after the measure on “ST + 0.000 mV”. The
operation is carried out in 4 steps.
First, rotate the Navigation Knob to move the base point (the red cross) horizontally to base line point (the base line is

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between the Q wave and the P wave). At this point, the frozen screen shows “ST+0.xxx mV, Set Base, Dirc Hor”
Second, press the Navigation Knob. The screen shows “ST+0.xxx mV, Set Base, Dirc Ver”. Then rotate the knob to
move the base point vertically to the base line point.
Third, press the Navigation Knob again. The screen shows “ST+0.xxx mV, Set ST, Dirc Hor”. Rotate the knob to move
the ST point (the yellow cross) horizontally to the point to be measured on the ST segment.
Last, press the Navigation Knob again. The screen shows “ST+0.xxx mV, Set ST, Dirc Ver”. Rotate the knob to move the
ST point vertically to the point to be measured on the ST segment.

One the main screen allows pressing the (Freeze) key to enter the ST segment analysis screen.
NOTE: The S point is the end point of S wave, and the T point is the start point of T wave.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

4.4 Mode Selection Screen


Press the Navigation Knob in the main screen as shown in Figure 4.2, the operating area shows the mode selection
screen, as shown in Figure 4.11.

Figure 4.11 Mode Selection Screen


In the mode selection screen, rotate the knob to move the gray cursor to the corresponding screen. Press the knob to enter
the screen of SpO2, NIBP, TREND, RCALL, VPC, SETUP, COLOR, FILE, oxyCRG, EVENT and MC. Press “Exit” to
exit from Mode Selection Screen.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu.

4.4.1 SpO2 Data List Screen


Move the gray cursor to SpO2 in the mode selection screen, and press Navigation Knob to enter into SpO2 data list
screen, shown as Figure 4.12

Figure 4.12 SpO2 Data List Screen

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Screen Description
The SpO2 data list screen is similar with the data listing screen described before. The difference is the title bar colors.
The operation is also similar to the data listing screen, please refer to the previous chapters.
All the parameters in the SpO2 data list are corresponding to the time when the SpO2 measurements were taken. There is
only one record every 4 seconds.
Another difference is that the SpO2 screen can list up to 13 groups of data.
☞ Press print key to print SpO2 list on the SpO2 List Screen.

4.4.2 Blood Pressure Data List Screen

Figure 4.13 NIBP Data List


The time shows the time when the measurement was taken. As shown in Figure 4.13, one blood pressure listing screen
can list up to 13 groups of blood pressure data. When the measured data exceeds 13 groups, we can use the Navigation
Knob to scroll up and down to show the complete listing.

☞ Press print key to print NIBP list on the NIBP List Screen.
4.4.3 Graphic Trend Screen
Screen Description
Move the gray cursor to the “TREND” button, press the knob, and you will get the screen as shown in Figure 4.14.

Figure 4.14 Graphic Trend


This is the graphic trend selection screen, i.e. Trend Menu screen.
If you want to enter one of the trend graphs, the procedures are: rotate the knob, move the cursor to one of the parameter.
For example, from the left to right, we are entering “heart rate”, “Respiration Rate”, “Temperature”, SpO2 and NIBP
trend graphs. Their screens are described in the following figures.

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Figure 4.15 ECG Graphic Trend


Figure 4.15 is the ECG trend graph. There are 3 options on the right of the graph, as described below.
The “6” on the top shows the trend graph time. Move the cursor to the trend time, press the knob and rotate it, and the
trend graph time will change to 24, 120 or 480, which changes the horizontal coordinates to be 24 hours, 120 hours or
480hours. The corresponding trend graph also changes to 24 - hour trend, 120 - hour trend or 480 - hour trend.
After choosing “Scan”, the trend graph display a triangle and a vertical line, a moving ruler mark that can be moved by
rotating the knob. As shown in the figure, when you move the mark to a specific point, the data area below the graph will
display the time, and its corresponding heart rate, respiration rate, SpO2, temperatureⅠ, temperatureⅡ. When rotating
Navigation Knob to move the mark, the moving interval is a changing value. The rule is that the initial step is 1, after
moving it towards the same direction 5 times, the interval becomes 5, and with 5 more steps the interval becomes 10,
then 20 and 40. No matter what the interval is, as long as you move towards the other direction, the interval becomes 1
of the other direction. Therefore, it is very easy to find the time you are looking for.
The last key on the right is “Exit”. Move the cursor to the Exit, and press the knob to return to the previous screen. The
screen returned to is the Mode Selection screen.
Please note that the maximum value on the vertical coordinates of the ECG is 150, not the value of ECG upper limit 300.
The graph is scaled down for better view of the waveforms. When the ECG value exceeds 150, the vertical coordinate’s
maximum value will automatically change to 300. That is to say, the vertical axis value 0-75-150 will change to
0-150-300 automatically if the ECG value exceeds 150. When system gets reset or the patient ID is changed, the vertical
coordinate will return to its original value of 0, 75, and 150. Other changes of vertical coordinate value in other trend
graph are similar to that of ECG.
The Trend graph shows parameter value of the current time. For example, in the 6 hours trend graph, when the
monitoring time exceeds 6 hours, the data 6 hours ago will be move out of the graph. This ensures the screen always
display the current data for review. The data moved out of the graph is not deleted but is just hidden temporarily. When
the time frame changes from 6 hours to 24 hours (while the monitoring time is less than 24 hours), the complete set of
data will display. Other trend graph follows the same rule.
The respiration rate, body temperature and other trend graph are similar to that of ECG’s and we will not cover them in
detail again. Please note that for those trend graphs, the horizontal coordinate is the number of times the blood pressure
measured in stead of time.
NIBP graphic trend is a little different from the other graphic trends. Rotate the knob to move the cursor to
“ ”, then press the knob for activing this item. Next, rotate the knob towards left or right for viewing another
400 groups’ graphic trend.

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Figure 4.16 ST Graphic Trend

Figure 4.17 Body Temperature Graphic Trend

Figure 4.18 NIBP Graphic Trend

Figure 4.19 SpO2 Graphic Trend

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Figure 4.20 Pulse Rate Graphic Trend

Figure 4.21 Respiration Graphic Trend

Figure 4.22 EtCO2 Graphic Trend


Operating Instructions
Rotate the knob, choose the parameter and press the knob to review the trend graph, and move the cursor to the Exit to
exit the trend graph.
In the temperature trend graph, the Temperature 1 is dotted in white and Temperature 2 is dotted in green.
☞ Press print key to print the trend graph on its corresponding Trend Graph Screen.

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4.4.4 Recall Screen


Move the gray cursor to RECALL in mode selection screen and press the Navigation Knob to enter waveform Recall
Screen, shown as Figure 4.23.

Figure 4.23 Waveform Recall Screen


Shown as Figure 4.24, it is different from the main screen in its 3rd waveform area and the operation area. We will
explain them in details below.

Figure 4.24 Recall Listing


Rotate the Navigation Knob and choose “Recall”, “HIST”, “Delete” or “Exit”. We explain the functions of each button
below.
Recall: press the Recall and the first record in recall list becomes green. Rotate the knob to choose a record, and press
the knob to recall it. The recalled waveform is displayed on the 3rd channel of the waveform area, as shown in Figure
4.25.

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Figure 4.25 Recalled Waveform


Rotate the Navigation Knob to move forward or backward to review the waveform. Press the Navigation Knob to exit
the waveform recall and return to the initial waveform recall screen.
During waveform recall, the system not only displays the current recalled waveform, but also displays the lead status,
gain and filter type of the waveform and time.
HIST: press the key to shift between the history key and current key. Press HIST and the recall list on the left displays
the history data list. Press the Current, the recall list on the left side displays the current one. When entering the recall
screen, the system defaults the current one.
Delete: press this key, and the selected record in the recall list becomes green. Rotate the Navigation Knob to choose the
reviewed record that is to be detected, press it, release it 2 seconds later, and then the record is deleted. The current
record cannot be deleted.
Exit: press this key to return to the system setup menu.
☞ Press print key to print the recalled data list. If a piece of record is chosen, press print key to print leadⅡ ECG
waveform and the recalled waveform on the Waveform Recall Screen.

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4.4.5 VPC Screen


Move the gray cursor to “VPC” and press Navigation Knob to enter VPC screen, shown in Figure 4.26. The structure is
similar to recall screen. We will cover each function key below.

Figure 4.26 VPC Screen


Start: This button is used to start and end the system arrhythmia detection. The default is OFF. When the VPC is not ON,
the learn key is disabled. Press this key and the system enters learning mode. The Start changes to End. Press it again to
end the learning. When “Learn” key change to yellow from gray, it indicates the learning has finished. After the
arrhythmia detection is begins, the system will automatically detect the arrhythmia waveforms. If arrhythmia is detected,
the arrhythmia waveform will be displayed in the 3rd ECG channel, shown in Figure 4.26
When the system get reset or the patient has change, the arrhythmia needs to be re-learned.
Learn: Because the arrhythmia detection is based on the normal ECG waveform at the same speed and same amplitude,
when the patient changes, or the arrhythmia detection is incorrect, the arrhythmia needs re-learn. To better use the learn
function, it is recommended to use a good ECG waveform to learn during the monitoring.
View: Press this key, and the selected record in the VPC list, which is to be reviewed, becomes the green. Rotate the
Navigation Knob to choose the record and display the corresponding waveform in the 3rd ECG channel. Press the knob
again to exit.
Exit: press this key to exit the arrhythmia detection screen and return to the system menu.
During monitoring, if arrhythmia is detected, the system will alarm. The VPC alarm is system default and does not need
setup.
During arrhythmia detection, incorrect detection might occur if the non-ECG waveforms (e.g. square wave and triangle
wave) appear.
Before start 1mV testing, please turn off the arrhythmia detection.
During arrhythmia detection, the arrhythmia module is very important. The system requires a group of stable ECG
waveforms. If the system detects the arrhythmia incorrectly, please re-learn arrhythmia by pressing “Learn” button and
capture correct template.

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☞ Press print key to print the arrhythmia data list. If a piece of record is chosen, press print key to print leadⅡ ECG
waveform and arrhythmia waveform on the VPC Screen.

4.4.6 System Setup Screen


Screen Description
In the Mode Selection screen, move the cursor to the “SETUP”, and press it to enter system setup screen, shown in
Figure 4.27.
To set up the system parameter, rotate the Navigation Knob to move the cursor to the corresponding button, and press it
to perform corresponding settings.
At the same time, the DEF button returns the settings to the default value, but the patient document and the recalled data
will not be changed. We will cover the functions of each button.
☞ Press print key to print its corresponding parameter settings on the setup screen.
SYSTEM PARAMETER SETTINGS

Figure 4.27 System Parameter Settings


— Type: The subject being monitored, this can be selected among Adult, Child and Neonate.
Adult: the subject is adult.
Infant: the subject is pediatric patient.
Neonate: the subject is neonate.
The default is “Adult”.
When changing the patient type, the system will perform the alarm settings, NIBP settings initializations.
Please pay special attention to the patient type before starting the monitoring. It is forbidden to use Adult
type on the infant patient. Doing so can cause serious injury.
— Mode: Monitor mode selection. The Real Time shows the real time waveform, i.e. normal monitoring state.
The DEMO shows the demo waveforms. In the demo state, all the signals and data are generated from the
patient monitor for demo and testing purpose. The default is “Real Time”
— Lang: for setting the display language. The patient monitor is equipped with dual-language, the primary and
secondary languages, which can be switched alternatively by user. The default language configuration is
"ENG" (English) as the primary language, "中文" (Chinese) as the secondary language. The available
secondary languages can be configured optionally with "中文" (Chinese), "ENG" (English), "PTG"
(Portuguese), "CSK" (Czechish), "TRK" (Turkish), “APA”(Spanish) and "FRA" (French) etc.. For the
special configuration without the secondary language, the display language is always "ENG" (English), and
this setting item is gray so that it can not be set.

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— Fill: When the fill setting is ON, the display fills the volume for the SpO2 and Respiration. When it is OFF,
the system displays the line graph. The default is OFF.
— Frze: Pressed the key to freeze the selected waveform. The options are “All” and “ECG”. When ECG is
selected, the system only freezes the ECG waveform. When “All” is selected, the system freezes all the
waveforms including ECG, SpO2, and Respiration. The factory default is “ECG”
— Disp2: The screen can display the observe screen or seven ECG waveforms on the same screen.
— VOL: The sound volume. The maximum volume is 7 and minimum is 0, i.e. no sound. The default is 5.
— Key: If the setting is ON, the press of the button will generate a keystroke sound. The factory is ON.
— Beep: The synchronous heart beat sound. The range of setting is “0~7”, The factory default is “5”
PRINTER PARAMETER SETTINGS

Figure 4.28 Printer Parameter Settings


— Printer: Printer switch. If the printer option is “ON”, the printer will be available. This parameter does not
have default, but the choice can be stored.
— Timer: It is the switch of the automatic print timer. When the set is “ON”, 1 minute to 240 minutes (the
intervals at which the system will print the information automatically) adjustable. When the time setting is
reached, the system will automatically print waveform information. The default is “OFF”.
— Wav2: When the Printer option is “ON”, it will be available. The first printed waveform is Lead II ECG
waveform, and the second printed waveform is optional. The SpO2, respiration, and Lead I, III, AVR, AVL,
AVF, V ECG waveforms can be selected. The default is “SpO2”.
— VPC: When the option is “ON”, the printer will be triggered on when arrhythmia appear, and record
waveform data automatically. The default is “OFF”.
ECG PARAMETER SETTINGS

Figure 4.29 ECG Parameter Settings

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— Lead: Can choose from I, II, III, AVR, AVL, AVF, V (V1-V6). The default is I.
— Gain: The ECG gain, 5 options x1/2, x1, x2, x4 and Auto. Auto is for automatic gain control. The factory
default is x1
— HR Hi: upper limit of heart rate alarm
Lo: lower upper limit of heart rate alarm
The adjustable range and the factory default value can be found in chapter 3
— Speed: ECG display speed. 3 options: 12.5, 25, 50 mm/s. The factory default is 25 mm/s
— Mode: ECG filter mode. Three options: MON, DIA, and OPE
MON: monitoring mode. Moderate filtering that can filter out interference and present good ECG
waves.
DIA: Diagnosis. No filtering, represent the true ECG with out filtering.
OPE: Operation. Deep filtering, filtering out strong interference.
The factory default is MON.
— BtSnd: Heart beat sound. The synchronous heart beat sound during monitoring. The factory default is ON.
— 1mV: Generating the 1mV signal. This signal is used to test the function of the machine. It is not used
during normal operation. Factory default is OFF
— ST Hi: The high limit value of ST Segment
Lo: The low limit value of ST Segment.
— 50Hz: 50 Hz frequency filter. The factory default is ON.
— Pace: Cardiac pacemaker detection. When Pace is “ON”, a mark will be displayed on the ECG waveform if
the patient fitted with a cardiac pacemaker. The factory default is OFF.

— Grid: The grid on the background. Factory default is OFF.


☞ Limits setup: Move the gray cursor to the upper or lower limits of the alarm settings, and press the
(Alarm Silence) key to turn ON or OFF the alarm for the setting. Yellow color shows ON status, and gray
color show the OFF status.

RESPIRATORY PARAMETER SETTINGS

Figure 4.30 Respiration Settings

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— Gain: Respiration amplification/gain, 4 options, x1/2, x1, x2, x4, the default is x1
— Speed: Respiration display speed. 2 options 6.25mm/s and 12.5 mm/s. The factory setting is 12.5 mm/s
— Apnea: The apnea alarm time (in second). When the patient stop breathing for the time longer than the set
period, the Respiration display channel display warning “Apnea xxx second”.
— Type: Respiration impedance
— RR Hi: Upper limit of respiration rate alarm
Lo: Lower limit of respiration rate alarm
☞ Limits setup: Move the gray cursor to the upper or lower limits of the alarm settings, and press the
(Alarm Silence) key to turn ON or OFF the alarm for the setting. Yellow color shows ON status, and gray
color show the OFF status.
TEMPERATURE SETTINGS

Figure 4.31 Temperature Settings


— TEMP1 Hi:Upper limit of temperature 1 alarm
Lo:Lower limit of temperature 1 alarm
— TEMP2 Hi:Upper limit of temperature 2 alarm
Lo:Lower limit of temperature 2 alarm
☞ Limits setup: Move the gray cursor to the upper or lower limits of the alarm settings, and press the
(Alarm Silence) key to turn ON or OFF the alarm for the setting. Yellow color shows ON status, and gray
color show the OFF status.
— Unit:Temperature unit. The default is °C (Celsius) and it can be set to °F (Fahrenheit).
— TD: temperature difference.

NIBP PARAMETER SETTINGS

Figure 4.32 NIBP Settings

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— SYS Hi/Lo: upper and lower limits of systolic pressure alarm


— DIA Hi/Lo: upper and lower limits of diastolic pressure alarm
— MAP Hi/Lo: upper and lower limits of mean arterial pressure alarm
— PR Hi/Lo: upper and lower limits of pulse rate alarm
— Unit: the pressure unit. mmHg or kPa. The factory default is mmHg.
— Mode: The cuff inflation mode, manual or automatic. The factory default is manual. The operator needs to
press the (NIBP) button to perform NIBP measurement. If the Auto mode is chosen, the operator needs
to set an interval cycle as well.
— Cycle: The inflation interval when the NIBP measurement is set as Auto. The options are STAT, 1 min, 2
min…480min. Press (NIBP) key and the system begins to count down. It takes blood pressure
measurement automatically after finishing counting down If STAT is selected, press (NIBP) Key to take
5 minutes’ measurement.
 WARNING: STAT can only be used for Adult. Using this mode to neonate can cause
serious injury.
SpO2 PARAMETER SETTINGS:

Figure 4.33 SpO2 Settings


— SpO2 Hi/Lo: upper and lower limits of SpO2 alarm
— Pulse Hi/Lo: upper and lower limits of pulse rate alarm

4.4.7 Color Settings screen

Figure 4.34 Color Setting Screen


Move the gray cursor to “Color” and press the Navigation Knob to enter color setting screen, shown in Figure 4.34. In
this screen, rotate the knob to choose the color, press and rotate it to change the color. When the appropriate color is
chosen press the knob again to save it.
Press the Exit to exit from this color settings screen.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu on Color
Setting Screen.

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4.4.8 File/Archive Management Screen

Figure 4.35 Document Management Screen


The document/archive management screen can be used to manage information about the patient. In the screen, the
operator can enter and modify the patient ID, name, Bed number, Sex, and Age. The operator can also choose to save the
patient data in the permanent storage. The screen is shown in Figure 4.35.
ID: or Patient ID. To enter patient ID, choose the patient ID field using the Navigation Knob. Press it to enter the
text entry box. Rotate the knob to choose the letter and press the knob to enter the letter. To delete the letter, move
the cursor to the letter to be deleted and rotate the knob to enter spaces (after the H). Use the spaces to replace
the letters. After finishing entering the patient ID, choose Exit button and press the knob to exit the text entry. The
patient ID is the unique identifier for the patient. When the patient ID changes, the system considers the patient has
changed.
Name: Enter the patient’s name.
Bed: Enter the patient’s bed number.
Sex: Choose between M or F for male and female.
Age: Choose the age field and use the rotate knob to select an age.
Save: The operator can choose how much of the data that needs to be saved. The unit is hour. Once the time is
chosen, the system starts to save data from the current time. If OFF is selected, it means that the data will not be
saved. The system will determine the time range according to the disk space available. If no disk space available,
SAVE will be displayed as OFF.
☞ Press print key to print leadⅡ ECG waveform and waveform 2 which can be selected in the system menu on the
Document Management Screen .

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4.4.9 oxyCRG Screen


In the mode selection screen, move the gray cursor to “oxyCRG” and press the Navigation Knob to enter oxyCRG
screen, shown in Figure 4.36. This screen displays the value or waveform of HR, SpO2, and Respiration waveform or
Respiration Rate in selected time. The time can be set as 1 minute, 2 minutes and 4 minutes by the lower left button.
Press the middle button to set the third channel waveform display: Respiration waveform or Respiration Rate. Press
“Exit” button or DISP key to exit form this screen.

Figure 4.36 oxyCRG Screen


☞ Press print key to print oxyCRG.

4.4.10 Event List Screen


In the mode selection screen, move the gray cursor to “EVENT” and press the Navigation Knob to enter Event List
screen, shown in Figure 4.37.

Figure 4.37 Event List


The event list displays the time, event type, the value detected and high and low alarm limits.

When the groups of data exceed one screen, please use the ↑ and ↓ arrow or rotate Navigation knob to scroll the data.

☞ Press print key to print event list.

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4.4.11 MC Calculator
In the mode selection screen, move the gray cursor to “MC” and press the Navigation Knob to enter MC analysis screen,
shown in Figure 4.38. This series monitor supplies 10 kinds of medicine calculation and titration display function.

Figure 4.38 Medicine Dosage Calculator Screen


Medicine Dosage Calculator

Medicine types which can be perform drug dosage calculation: AMINOPHYLLINE, DOBUTAMINE, DOPAMINE,
EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN, and PITOCIN.
Drug Dosage Calculation adopts the following formula:
Medicine Consistency (MC) =Medicine Gross/ Cubage
(Dose/minute)= (Dose/hour) /60
(Dose/Kg/m)= (Dose/m) /Weight
(Dose/Kg/h)= (Dose/h) /Weight
Transfusion Speed (TS) = (Dose/h) /MC
Drop Speed=TS/ (Cubage/drop)
Duration=Medicine Gross/Dose/h)
Formula Introduction: Dose/m=Dose per minute; Dose/h=Dose per hour; Dose/Kg/m=Dose per Kg per minute;
Dose/Kg/h=Dose per Kg per hour.

On medicine calculation screen, at first the operator should move the gray cursor to “Medicine” to select the calculated
medicine name, and then move the cursor to “Weight” to select and confirm patient weight, at this time MC analysis
screen is shown as Figure 4.39.

Figure 4.39 MC Analysis Screen

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Rotate the Navigation knob to move the cursor to the option which needs to be calculated, press the knob and rotate it to
obtain calculating value. When the calculating value is selected, the calculated value will be displayed in corresponding
position. Each calculating option has limit range, if the result exceeds range, it will display “…”.

 On MC analysis screen, other menu options can not enter value unless entering patient’s weight and
medicine name again, in default status it is no effective. The values in system is a group of stochastic
initial values, the operator should not consider it as calculating standard, please according to doctor’s
device enter a group values which are suitable for patient.

 The unit of every medicine is settled unit or unit series. The operator must select the appropriate unit
according to doctor’s device. In a unit series, unit carry performs automatic adjustment along with the
current entering value. When exceeding the range of this unit expression, the system will display “…”.

 When the operator finishes one option entering, the system will give visible indication in menu to
remind operator to check the correctness of entering value.

 Under neonate mode, “DS” and “Drop” are useless.

 For every new entering value, please perform confirming. The operator should take it seriously, only
the entering is correct, the calculating result is believable and reliable.

Select Medicine Type: Move the cursor to “Medicine”, rotate Navigation knob to perform selection. Ten options:
AMINOPHYLLINE, DOBUTAMINE, DOPAMINE, EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE,
NITROGLYCERIN, and PITOCIN. The default medicine is AMINOPHYLLINE.

Weight: when entering into medicine calculating window, the operator should enter patient’s weight; the weight is used
for MC calculation only; weight: 0.5Kg to 300Kg selectable; step: 0.5Kg; default: 70 Kg for adult; 20Kg for infant; 3.0
Kg for neonate.

 Medicine calculation function just supplies a medicine calculator function. The values in table can have
no relation with the monitored patient, so the weight in this menu and the weight in system are two
different values. When update a patient in system operation, the value in this menu will not be affected.

☞ Press print key to print patient information and relevant medicine information.

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User manual for Patient Monitor

Chapter 5 CO2 Monitoring


If your monitor has CO2 monitoring function, please follow the instructions in this chapter to
perform CO2 monitoring on patient.

5.1 CO2 Parameter Settings


1. On Main Screen, press the knob to enter System Menu Screen. Then choose “SETUPÆC02”to enter CO2
Parameter Settings screen.

CO2 Parameter Settings


— Switch: choosing the mode of CO2. It is recommended that the switch is turned on only when there is a need
to monitor CO2 parameter. This can not only reduce the power consumption and also extend the life of the
CO2 module.
In order to maintain the monitor, please set CO2 switch at OFF state in system setup when CO2 function is
not used.
— Gain: the CO2 waveform gain.
— Unit: Choosing the EtCO2 and the minimum InsCO2. It can be set up as kPa, mmHg, and %.
— Respiration Rate High: Setting the upper alarm limit of CO2 respiration rate.
Low: Setting the lower alarm limit of CO2 respiration rate.
— EtCO2 High: Setting the upper alarm limit of EtCO2.
Low: Setting the lower alarm limit of EtCO2.
— InsCO2 High: Setting the upper alarm limit of InsCO2.
Low: Setting the lower alarm limit of InsCO2.
— Baro (Barometric pressure): set ambient atmospheric pressure. It can be determined by barometer or the
ambient altitude. Altitude can be used to determine the typical barometric pressure if a barometer is not
available, refer to Appendix Typical Pressures and CO2 Readings at Altitudes for details.
— Zero: The method to calibrate CO2: Zero calibration. Calibration must be carried out in a drafty place, and
the CO2 module must have worked continuously for 5 minutes to ensure an accurate calibration, or the
calibration will not work.
— Flow (CO2 flow): It is flow rate of the CO2 sampling. Its value is 50ml/min.

The information promoted for Zero calibration is as follows:

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Please apply the reference air with 0% CO2, the air in the drafty room usually can be regarded as the air with 0% CO2.
Press “OK”, and the result will be displayed on the screen several seconds later.
2. To set the color of CO2 parameters on Color Settings screen.

5.2 CO2 Sensor Connection


5.2.1 Sidestream CO2 Sensor Connection

Demonstration for Sidestream CO2 Sensor Connection


1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labeled “CO2” on the connector panel of
the monitor;
2. The sample cell of the sampling cannula must be inserted into the sample cell receptacle of the CO2 Sensor. A “click”
will be heard when the sample cell is properly inserted. Then connect to airway tube. After finishing sensor
connection, and make sure that the air input end is exposed to room air and away from all sources of CO2, including
the ventilator, the patient’s breath and your own. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2
minutes for the sensor warm-up.
3. Default Tubing Configuration

Adapter and Sampling tube (Single patient use)

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Extending airway tube for connecting to sampling tube (Single patient use)

Wye Connector

4. Optional sampling cannula kits

(1) T connector sampling cannula kits

On-air Connector

Adapter
(2) Nasal Sidestream Cannula Kits

(3) Oral Sidestream Cannula Kits

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5.2.2 Mainstream CO2 Sensor Connection

Sensor cable

Adapter

CO2 sensor

Demonstration for Mainstream CO2 Sensor Connection


1. Take out the CO2 Sensor and insert the CO2 Sensor Cable into the connector labeled “CO2” on the connector panel of
the monitor;
2. Snap the CO2 sensor onto the airway adapter as shown in Figure 6.9. A “click” will be heard when the airway adapter
is properly inserted.
3. Position the airway adapter in the patient’s respiratory circuit (as close to the patient as possible) between the
endotracheal tube and the ventilator circuit. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2 minutes
for the sensor warm-up.

Safety Introductions for CO2 Monitoring


0 CO2 Sensor is a precision measuring part, please use it correctly and store it
properly;
0 Precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI)
to and from other equipment.
0 Failure of Operation: If the CO2 Sensor fails to respond as described in this user
manual; DO NOT use it until approved for use by qualified personnel.
0 DO NOT position the sensor cables or tubing in any manner that may cause
entanglement or strangulation.
0 Support the airway adapter to prevent stress on the ET tube.
0 Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2

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airway adapters may compromise functionality and system performance leading to


a user or patient hazard. Performance is not guaranteed if an item labeled as single
patient use is reused.
0 Inspect the sidestream on-airway adapters and sidestream sampling kits for damage
prior to use. DO NOT use the sidestream on-airway adapters and sidestream
sampling kits if they appear to be damaged or broken.
0 If the CO2 waveform (Capnogram) appears abnormal, inspect the CO2 airway
adapters and replace if needed.
0 Periodically check the CO 2 /Flow sensor and tubing for excessive moisture
or secretion buildup. Do not use them if there is excessive moisture or exterior
condensation.
0 Electric Shock Hazard: The CO2 Sensor contains no user serviceable parts.
0 Refer service to qualified service personnel. Do not open the sensor cabinet at will,
as electric shock hazard may occur.
0 Place the exhaust vent of the CO2 Sensor in drafty ambient and do not let anything
block the exhaust vent.
0 Always disconnect the CO2 Sensor before cleaning. Do NOT use if it appears to have been
damaged. Refer servicing to qualified service personnel.
0 DO NOT sterilize or immerse the CO2 Sensor in liquids.
0 Replace the sidestream on-airway adapters and sidestream sampling kits if excessive
secretions are observed.
0 Do not operate the CO2 Sensor when it is wet or has exterior condensation.
0 Monitor the CO2 waveform (Capnogram). If you see changes or abnormal
appearance, check the patient and the sampling line. Replace line if needed.
0 DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min
+/- 10 ml/min from the airway or patients that can not tolerate the added dead space
to the airway.
0 Do not apply excessive tension to any sensor cable or pneumatic tubing.
0 Explosion Hazard: DO NOT use in the presence of flammable anesthetics or other
flammable gasses. Use of the CO2 Sensor in such environment may present an
explosion hazard.
☞ The power voltage over monitor working voltage may cause damage to CO2 sensor.
Likewise, too low power voltage may affect the CO2 measuring accuracy or even
make the CO2 sensor not work.
☞ When changing sampling tube, it is suggested to choose the default sampling tube
with dehumidifying function. The sampling tube without dehumidifying function
may be easily blocked by excessive moisture. (Use life: ordinary sampling tube: 6~12
hours; the sampling tube with dehumidifying function: about 120 hours.)
☞ If the measurement appears abnormity caused by sampling tube block, please
replace it.
☞ The total length of the sampling tube and extending airway tube shouldn’t be longer
than 3 meters, too long may cause measurement abnormity. If using T connector
sampling cannula kits, please insert the sampling tube with the tubes upward to
avoid the affects of excessive moisture;

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☞ Altitudes are different in different area, so set the Barometric Pressure setting value
as the ambient barometric pressure.
☞ Use only our company approved accessories.
☞ While using the CO2 sensor, a system leak, that may be caused by an uncuffed
endotracheal tube or a damaged CO2 sensor may significantly effect flow-related
readings. These include flow, volume, pressure and other respiratory parameters.
☞ When stopping CO2 monitor, please disconnected the CO2 sensor from the patient
monitor.
☞ Disposal of the CO2 Sensor and its accessories should comply with national and/or
local requirements.
☞ In the presence of electromagnetic devices (i.e., electrocautery), patient monitoring may be
interrupted due to electromagnetic interference. Electromagnetic fields up to 20 V/m will
not adversely affect system performance.
☞ Nitrous oxide, elevated levels of oxygen, helium and halogenated hydrocarbons can
influence the CO2 measurement.
☞ Excessive moisture in the CO2 may affect the accuracy of the flow measurement.

5.3 CO2 Monitoring Screen

Waveform area
— 5th waveform: CO2 waveform. It can be respiration waveform or CO2 waveform.

Data area

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RR, EtCO2, and Ins Data Area


— “RR”: Respiration Rate: The rpm after that is the unit of the respiration, i.e., respiration per min.
— “EtCO2 39.0”: The label and the value will become gray when CO2 is turned off.
— Ins: The label of the minimal inhalational CO2, the label and the value will become gray when CO2 is turned
off.
— “16”: Respiration rate. It will display the respiration rate of CO2, when the switch is turned on.
— “X1”: Respiration gain(amplification) :
“X1/2” half of the basic waveform
“X1” basic waveform
“X2” Twice the size of the basic waveform.
“X4” 4 times of the basic waveform
Observing Screen, 7 Leads on the Same Screen and other display screen will display CO2 monitoring data as well
besides Main Screen.

Note: only when the setting item “System Menu→SETUP→CO2→Switch”is set as “ON”, CO2 monitoring
function is available.

5.4 CO2 Graphic Trend


On Graphic Trend screen, rotate the knob and move the cursor to “CO2”, then press the knob to enter EtCO2 Graphic
Trend. Refer to Chapter 4.5 Graphic Trend Screen for detailed instructions and operations.

EtCO2 Graphic Trend

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Chapter 6 Alarm

6.1 Alarm Priority


High Priority:

Over HR limit
Over RR limit
Over TEMP1 limit
Over TEMP2 limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit
Over NIBP DIA limit
Over NIBP MAP limit
Over EtCO2 limit
Over InsCO2 limit
Over TD limit
Over ST limit
Over NIBP PR limit
ECG VPCEST
Unable to detect HR
Unable to detect SpO2
The battery capacity will exhaust
Medium Priority:
VE RONT
SVE RONT
Lead Off
Probe Off
Sensor Over Temp
Sensor Faulty
Zero Required
CO2 Out of Range
Check Airway Adapter
Check Sampling Line
The Sensor Off
Low Priority:
Other arrhythmia phenomenon(Except ECG VPCEST, VE RONT and SVE RONT, refer to 12.3 Abbreviation of
arrhythmia for details.)

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6.2 Alarm modes


When an alarm occurs, the monitor responds with visual alarm indications (which are shown by two ways: alarm
indicator and alarm message description) and audible alarm indications.
Visual Alarm Indicators
The flashing rates for the three categories of alarms are shown in the table below.

Indicator Color Alarm Caregory Flashing Rate


Red flashing High priority alarm 2 Hz
Yellow flashing Medium priority alarm 0.5 Hz
Yellow light Low priority alarm Constant(on)(non-flashing)

Audible Alarm Indications


The audible alarm has different tone pitch and on-off beep patterns for each priority category. These are summarized
in the Table below.
Alarm Category Tone Pitch Beep Rate

High priority alarm ~500Hz 2 beeps per 7 sec.


Medium priority alarm ~700Hz 4 beeps per 9 sec.
Low priority alarm ~600Hz 20 beeps per 13 sec.
Normal ~300Hz continuous

Note: Visual alarm indicators can not be suspended or removed. Audible alarms may be decreased in volume or
silenced.

6.3 Alarm Silence


Press key to set or activate the system alarm. In the monitoring screen, press “Alarm” to set the alarm timer. There
are four options of alarm silent time: 2 minutes, 5 minutes, 10 minutes and 20 minutes. The time shows up on the upper
left corner of the screen. When the alarm timer is activated, the system begins to count down. If alarm occurs during that
period, the system alarm will be actived automatically and the monitor will give alarm. If there is no alarm during that
period, when the set time has passed the system alarm will be actived as well. When the monitor alarms, press key
to suspend the alarm and set the alarm silence time.

0 DO NOT silence the audible alarm or decrease its volume if patient safety could be
compromised.
0 zero value alarm occures must be on the condition of probe not off. If spo2 value is
zero dispalyed on the screen instead of normal value, the zero value alarm will
automatically active if the state lasts for about 7 seconds .

6.4 Alarm Setting


In the Mode Selection screen, move the cursor to the “SETUP”, and press it to enter system setup screen.
Limits setup: Move the gray cursor to the High or Low limits of the alarm settings, and press the “Alarm” key to
turn ON or OFF the alarm for the setting. Yellow color shows ON status, and gray color shows the OFF status.
Refer to Chapter 12.2 for detailed Default Alarming Values of All Parameters and Setup Range.

0 Whenever the monitor is used, check the alarm limits to ensure that they are
appropriate for the patient being monitored.

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6.5 Verify Adjustable Alarm Function


To verify adjustable alarm function, select “Demo” for the item of Mode in system parameter settings menu and adjust
alarm limits or change alarm setting, then pay a close attention to the alarm. If the alarm is sent out according to your
setting, it means the alarm function is effective.

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Chapter 7 Technical Specifications


7.1 ECG Monitoring
1. Input signals range in amplitude: ± (0.5 mVp ~ 5 mVp)
2. Heart rate display range: 15 bpm ~ 350 bpm
3. Heart rate display accuracy: ± 1% or ± 2 bpm, whichever is greater.
4. Heart rate averaging: Averages the recent eight beats having RR intervals falling within the acceptable limits.
5. Heart rate alarm delay time: ≤ 10s
6. Response time to change in heart rate:
Change from 80 bpm to 120 bpm: < 8 sec
Change from 80 bpm to 40 bpm: < 8 sec
7. Tall T-wave rejection: Rejects all T-wave less than or equal to 120% of 1mV QRS.
8. Pacemaker pulse rejection:
Rejects all pulses of amplitude ± 2mV to ± 700mV and duration 0.1 to 2 ms without overshoot;
Rejects all pulses of amplitude ± 2mV to ± 400mV and duration 0.1 to 2 ms with overshoot.
9.Sensitivity selection:
×1/2, 5mm/mV tolerance: ± 5%
×1, 10mm/mV tolerance: ± 5%
×2, 20mm/mV tolerance: ± 5%
10. Sweeping speed: 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s tolerance: ±10%
11. ECG noise level: ≤ 30μVP-P.
12. ECG input loop current: ≤ 0.1μA
13. Differential input impedance: ≥ 5MΩ
14. Common-mode rejection ratio (CMRR): ≥ 89dB
15. Time constant:
Monitoring mode: ≥ 0.3s Diagnostic mode: ≥ 3.2s

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16. Frequency response:


Monitoring mode: 0.5 Hz~40 Hz(+0.4dB
-3.0dB)
Diagnostic mode: 0.05 Hz~75 Hz(+0.4dB
-3.0dB)
Additional declarations to conform the particular standard of IEC 60601-2-27 “Medical
electrical equipment – Part 2-27: Particular requirements for the safety, including
essential performance, of electrocardiographic monitoring equipment”
Direct current for Applied current less than 0.1 microamperes.
respiration, leads-off
sensing, and active noise
suppression
Response to irregular A1 Ventricular bigeminy-80BPM
rhythm A2 Slow alternating ventricular bigeminy-60BPM
A3 Rapid alternating ventricular bigeminy-120BPM
A4 Bidirectional systoles-90BPM
Time to ALARM for Waveform B1, Amplitude Average Time to Alarm
tachycardia 0.5 mV <8 sec
1 mV <8 sec
2mV <8 sec
Waveform B2, Amplitude Average Time to Alarm
1mV <8 sec
2mV <8 sec
4mV <8 sec

7.2 RESP Monitoring


1. RESP rate measuring range: 0rpm~120rpm
2. RESP rate accuracy: ±5% or ±2 rpm, whichever is greater
3. RESP rate alarm limit range: 0rpm~120rpm.
4. Alarm tolerance: ±5% or ±2 rpm, whichever is greater

7.3 TEMP Monitoring


1. TEMP measuring range: 25.0℃~45.0℃
2. TEMP measuring accuracy: ±0.2℃
3. TEMP responding time: ≤150s

7.4 NIBP Monitoring


1. Measuring method: Oscillometric Technique
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg
3. Accuracy of pressure measurement: ±3 mmHg
4. Cuff inflation time: <10 seconds (typical adult cuff)
5. Measurement time on the average: < 90 seconds
6. Air release time while the measurement is canceled: <2 seconds (typical adult cuff)
7. Initial cuff inflation pressure
Adult: <180 mmHg; Infant: <120 mmHg; Neonate: <90 mmHg

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8. Overpressure protection limit


Adult: 300 mmHg; Infant: 240mmHg; Neonate: 150 mmHg
9. NIBP measurement range:
press(unit) Adult Infant Neonate
SYS mmHg 40~255 40~200 40~135
MAP mmHg 20~215 20~165 20~110
DIA mmHg 10~195 10~150 10~95

10. NIBP accuracy:


Maximum mean difference : ±5 mmHg
Maximum standard deviation: 8 mmHg
11. Measurement mode: Manual, Auto, STAT

7.5 SpO2 Monitoring


1. Probe: dual-wavelength LED
Wavelength: Red light: 660 nm, Infrared light: 905 nm.
Maximal optical output power: less than 2mW maximum average
2. SpO2 measuring range: 0%~100%
3. SpO2 measuring accuracy: not greater than 2% for SpO2 range from 70% to 100%
*NOTE: accuracy defined as root-mean-square value of deviation according to ISO 9919
4. Low perfusion performance: the declared accuracy is sustained when the pulse amplitude modulation ratio is as
low as 0.4%

7.6 Pulse Monitoring


1. Pulse rate measuring range: 30bpm~240bpm
2. Pulse rate measurement accuracy: ±2bpm or ±2%, whichever is greater.

7.7 CO2 Monitoring


1. Technology: Infrared absorption method.
2. Mode of Sampling: Sidestream or Mainstream
3. CO2 Response Time:
Sidestream: <3seconds (including transport time and rise time).
Mainstream: <60ms (rise time)
4. Warm-up Time: Not less than two minutes
5. CO2 measurement range: 0~150mmHg
6. CO2 Accuracy: 0~40mmHg ±2mmHg
41~70mmHg ±5% of reading
71~100mmHg ±8% of reading
101~150mmHg ±10% of reading
*NOTE: Gas temperature at 25°C for Sidestream;
Gas temperature at 35°C for Mainstream
7. Flow rate: 50ml/min ±10 ml/min (Sidestream)

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7.8 Data Recording


1. Sensitivity selection tolerance: ±5%
2. Recording speed: 25mm/s
3. Recording speed accuracy: ±10%
4. Hysteresis: ≤0.5mm
5. Frequency response:
Monitoring mode: 0.5~40Hz Diagnostic mode: 0.05~75Hz
6. Time constant:
Monitoring mode: ≥0.3s Diagnostic mode: ≥3.2s

7.9 Other Technical Specifications


1. Power supply: 100~240VAC, 50/60Hz
2. Power consumption: see the nameplate on the monitor
3. Display mode: 12.1 inches TFT color LCD
4. Alarming mode: Audible & visible alarm
5. Communication: Net port

7.10 Classification

Safety standard: IEC 60601-1


The type of protection against electric shock ClassⅠequipment
The degree of protection against electric shock Type BF, CF applied parts
Electro-Magnetic Compatibility: Group I, Class A

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7.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility


Table 1
Guidance and manufacturer’s declaration-electromagnetic emission-
for all EQUIPMENT AND SYSTEMS

Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the equipment or system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment-guidance

RF emissions Patient Monitor uses RF energy only for its internal


CISPR 11 function. Therefore, its RF emissions are very low and are
Group 1
not likely to cause any interference in nearby electronic
equipment.
RF emissions Patient Monitor is suitable for use in all establishments
CISPR 11 Class A other than domestic and those directly connected to the
public low-voltage power supply network that supplies
Harmonic emissions
buildings used for domestic purposes.
IEC61000-3-2 Class A

Voltage
fluctuations/flicker
Complies
emissions
IEC61000-3-3

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Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity
for all EQUIPMENT AND SYSTEMS

Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the equipment or system should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC60601 test level Compliance level
-guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete
discharge(ESD) ±8kV air ±8kV air or ceramic tile. if floors are
IEC61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%
Electrical fast ±2kV for power ±2kV for power Mains power quality should be
transient/burst Supply lines Supply lines that of a typical commercial or
±1 kV for ±1 kV for hospital environment.
IEC61000-4-4 input/output lines input/output lines

Surge ±1kV line (s) to line(s) ±1kV differential Mains power quality should be
IEC 61000-4-5 ±2kV line(s) to earth mode that of a typical commercial or
±2kV common hospital environment.
mode
Voltage dips, short Mains power quality should be
interruptions and voltage that of a typical commercial or
variations on power hospital environment. If the user
supply input lines of the equipment or system
IEC61000-4-11 requires continued operation
during power mains interruptions,
it is recommended that the
equipment or system be powered
from an uninterruptible power
supply or a battery.

Power Power frequency magnetic fields


frequency(50Hz/60Hz) should be at levels characteristic of
magnetic field a typical location in a typical
3A/m 3A/m
IEC61000-4-8 commercial or hospital
environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity-for
EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of Patient Monitor should assure that it is used in such an electromagnetic environment.
Compliance
IMMUNITY test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part of
Patient Monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF 3V
Recommended separation distance
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz

Radiated RF 3 V/m
IEC 61000-4-3 3 V/m
80 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey ,a
should be less than the compliance level in each
frequency range .b
Interference may occur in the vicinity of
equipment marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and
electromagnetic site survey should be considered. If the measured field strength in the location in which Patient
Monitor is used exceeds the applicable RF compliance level above, Patient Monitor should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating Patient Monitor.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

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Table 4
Recommended separation distances between portable and mobile RF
communications equipment and The equipment or system-
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment or system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the equipment or system as recommended below, according to the maximum output power
of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum m
output power of 150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz
transmitter
W

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be determined using the equation applicable to the frequency of the transmitter, where p is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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Chapter 8 Packaging and Accessories

8.1 Packaging
The product is packed in high quality corrugated cartons with foam inside to protect the apparatus against damage in the
handling process.
Gross weight: Details see the indication on the outer package
Dimension: 500(L) ×320(W) ×460(H) mm

8.2 Accessories
(1) ECG lead cable One set
(2) NIBP cuff One set
(3) SpO2 probe One piece
(4) Body temperature probe One piece
(5) Power supply cable One piece
(6) Equipotential grounding wire One piece
(7) Disposable electrode Ten pieces
(8) User Manual One copy
(9) Warranty One copy
(10) Quality certificate One copy
(11) Assembly report Two copies
(12) Dustproof mantle One set
(13) Printing paper (optional) Ten rolls
(14) CO2 accessories(optional)

For Mainstream For Sidestream


Mainstream sensor One set Sidestream Sensor One set
( CAPNOSTAT 5 ) (LoFlo C5)
Airway adapter One piece Sampling Line Kit One set

Note: The accessories are subject to change. Detailed items and quantity see the Packing List.

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Chapter 9 Parameters Monitoring


9.1 ECG Monitoring
9.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value
The electrocardiogram (ECG or EKG) is primarily a tool for evaluating the electrical events within the heart. The action
potentials of cardiac-muscle cells can be viewed as batteries that cause charge to move throughout the body fluids. These
currents represent the sum of the action potentials occurring simultaneously in many individual cells and can be detected
by recording electrodes at the surface of the skin. The figure below shows the system of the heart.

First of all, the hospital should be equipped with a 100~250V power supply system with a typical grounding wire. If big
interference in ECG continues, connect one end of the grounding wire provided with this equipment to the grounding
wire on the back panel of this monitor, and the other end to the special grounding wire, water pipe or radiator.
A common ECG plate electrode used together with this monitor has short shelf life. Generally, the shelf life is only one
month after the package is opened. When outdated plate electrode is used, due to skin’s contact impedance and big
electrode potential, the chance of interference will be increased, and the ECG baseline will have an unstable inclination.
Therefore, always use valid plate electrodes.
9.1.2 Factors affecting ECG signal
— Interference from Electrosurgical Unit;
— Doesn’t filter the interference waveform;
— Poor grounding;
— Electrodes are not placed properly;
— Use expired electrode or use disposable electrode repeatly;
— The skin placed electrode is uncleaned or poor contract caused by scurf and hair;
— Electrode long-time used.

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9.2 NIBP Monitoring


9.2.1 Measuring Principle
Blood pressure may be measured in an invasive way (whereby the sensor will be inserted into blood vessel directly) or a
non-invasive way. The non-invasive way includes several methodologies, such as the Korotkoff Sound Method and
oscillating method. The Korotkoff Sound Method is used as a conventional way, whereby stethoscope is used to
measure the blood pressure. By the oscillating method, an inflation pump will fill the air, and release it slowly. A
computer will record change of the cuff pressure when the air is released. With this record, the blood pressure value will
be determined. First of all, make sure the signal quality judgment by computer meets the requirements of accurate
calculation (such as sudden limb movement or cuff being hit during the measurement). If the answer is negative, give up
the calculation. If the answer is positive, proceed with calculation of the blood pressure value.

As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher than that of human ears,
the oscillating method uses different definitions for measurement of diastolic pressure, mean arterial pressure and
systolic pressure from the Korotkoff Sound Method. When the oscillating method is used, the circuit in the measuring
apparatus will separate the amplitude of the cuff pressure from its change with pulsation. With the oscillating method,
the blood pressure at the maximum amplitude of cuff pressure is defined as the mean arterial pressure. The blood
pressure at amplitude of cuff pressure forward reduced according to proper proportion is defined as systolic pressure,
while the blood pressure at amplitude of cuff pressure backward reduced according to proper proportion is defined as
diastolic pressure. The maximum change of pulse pressure occurs at these two points. They are equivalent to the point
with pulse sound and the point without pulse sound respectively in the Korotkoff Sound Method.

When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive monitoring method
shall be used.

Comparison between blood pressure measuring methods


To overcome the effect of human hearing variation and air release speed on measurement accuracy when the
conventional Korotkoff Sound Method is used to take measure of blood pressure, people have been dedicated to study of
automatic measurement of blood pressure. By now, automatic blood pressure measuring system based on the principle
of oscillating method is mature. In practice, however, various problems are encountered, such as why the measures
taken by the oscillating method is lower or higher than those taken by Korotkoff Sound Method? Why the measures are
inclined to decline? Why, in some cases, no result is obtained in spite of the inflation actions? Why the measure values
have big discreteness and even abnormal data in some cases? Why the SpO2 waveforms may disappear suddenly? ...and
so on. The following explanations are devised to give the answers.

The Oscillating method vs. the Korotkoff Sound Method

Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good correlation with the
invasive measurement. Notwithstanding, any of the non-invasive blood pressure measurements has its one-sidedness
when it is compared to the invasive measurement. The oscillating method has its advantages over the Korotkoff Sound
Method in less error, higher reliability and stability. Their differences may be reflected in the following aspects.
1. The measures by the Korotkoff Sound Method are liable to effect of human factors. For example, different
people may have different sound judging ability, or different reactivity when listening to heart sound and reading
mercury meter. The air release speed and subjectivity may also affect the judgment. By the oscillating method,
the computation is accomplished by the computer, thus relieving the possibility of effect due to human factor.
2. With the Korotkoff Sound Method, the measure is taken on the basis of appearance and disappearance of heart
sound. The air release speed and heart rate may have direct effect on the measurement accuracy. It also has the
disadvantages of rapid air release and poor accuracy. In the contrast, with the oscillating method, the
determination is calculated on the basis of cuff pressure oscillatory waveform envelope, and the air release
speed and heart rate has little effect on the measurement accuracy.

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3. Statistics show that, when measuring the hypertension, the measure taken by the oscillating method is likely to
be lower than that taken by the Korotkoff Sound Method. When measuring the hypotension, the measure taken
by the oscillating method is likely to be higher than that by the Korotkoff Sound Method. But, it doesn’t mean
the advantages or disadvantages between the oscillating method and the Korotkoff Sound Method. Comparison
with the results taken by more accurate method, let’s say comparison of the invasive pressure result with the
output value by the blood pressure measuring simulator, will show which method has more accurate results. In
addition, higher or lower value should be a statistical concept. It is recommended those used to adopt the
Korotkoff Sound Method use different physiological calibration for values determined by the oscillating method.
4. The studies have shown that the Korotkoff Sound Method has the worst accuracy when it comes to measurement
of hypotension, while the oscillating method has worse accuracy when it comes to measurement of controlled
hypertension relief.

9.2.2 Factors affecting NIBP measuring


Like common non-invasive blood pressure measurement, improper operation may cause inaccurate or blank result or
misunderstanding of the measuring information when the oscillating method is used to take the measure of blood
pressure. This point needs particular attention of the operators.
1. Requirements of the cuff:
1) Appropriate cuff should be selected according to the age of the subject. For more information, see Chapter 3.
2) Remember to empty the residual air in the cuff before the measurement is commenced.
3) Locate the cuff in such a way that the “φ” mark is at a location where the clearest pulsation of brachial artery
is observed.
4) The cuff should be tightened to a degree where insertion of one finger is allowed.
5) The lower end of the cuff should be 2cm above the elbow joint.
2. The subject should lie on the back so that the cuff and the heart are in a horizontal position and the most accurate
measure is taken. Other postures may lead to inaccurate measurement.
3. Do not speak or move before or during the measurement. Care should be taken so that the cuff will not be hit or
touched by other objects.
4. The measures should be taken at appropriate intervals. Continuous measurement at too short intervals may lead to
pressed arm, reduced blood flow and lower blood pressure, and resulting inaccurate measure of blood pressure.
It is recommended the measure be taken at intervals of more than two minutes.
5. With the oscillating method, when blood pressure is measured, the inflation pressure of the cuff will be
automatically adjusted according to the previous measure. Generally, the initial inflation pressure is 180mmHg
(for the adult mode) or 100mmHg (for the infant mode) or 80 mmHg (for the neonate mode) when it is powered
on. Following that, 50mmHg (for the adult mode) or 30mmHg (for infant mode) or 10mmHg (for the neonate
mode) will be added on the basis of the last measurement of systolic pressure. In this way, when the blood
pressure rises or the subject is changed, the blood pressure meter may fail in giving the result after the first-time
inflation. This monitor will automatically adjust the inflation pressure until the measure is taken, after that, up to
four measures will be allowed.
6. When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the infant or
neonate mode is selected.

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9.2.3 Clinical Limitations


1. Serious angiospasm, vasoconstriction, or too weak pulse.
2. When extremely low or high heart rate or serious arrhythmia of the subject occurs. Especially auricular
fibrillation will lead to unreliable or impossible measurement.
3. Do not take the measurement when the subject is connected with an artificial heart-lung machine.
4. Do not take the measurement when the subject uses diuresis or vasodilator.
5. When the subject is suffering from major hemorrhage, hypovolemic shock and other conditions with rapid
blood pressure change or when the subject has too low body temperature, the reading will not be reliable, for
reduced peripheral blood flow will lead to reduced arterial pulsation.
6. Subject with hyperadiposis;
In addition, statistics show that 37% people report blood pressure difference of no less than 0.80kPa(6mmHg)
between the left and right arms, and 13% people report difference of no less than 1.47kPa (11mmHg).
Note: Some practitioners may report big discreteness or abnormal value of the blood pressure measures when
the oscillating method is used. As a matter of fact, the so-called “big discreteness” must be a term in the sense of
statistical significance of mass data. Abnormal data may be observed in some individual cases. It is normal in the
scientific experiments. It may be caused by an apparent reason, or by an unknown factor in some cases. Such
individual doubtful experimental data may be identified and eliminated using the special statistical technique. It
is not a part of this manual. The practitioner may eliminate the apparently unreasonable data according to the
experience.
Operation Introduction:
1. Take a measurement in manual mode:
‹ Enter into the screen of NIBP setting, select “Mode” option and set it as “MANU”, and then press the
NIBP key on the front panel to start measure. If press the NIBP key again, the measurement will be
stopped.
‹ During the automatic measurement interval when no NIBP measurement is taken, press the NIBP key, a
measurement in manual mode will be taken. If at this time press the NIBP key again, the manual mode will
be stopped and continue the automatic mode.
2. Take a measurement in automatic mode:
Enter into the screen of NIBP setting, select “Cycle” option and select time interval according needs, then press
the NIBP key on the front panel to start the automatic measurement at a certain interval.
3. Stop automatic measurement
In the procedure of automatic measurement, press the NIBP key at any time, the measurement will be stopped.
4. STAT measurement
Enter into the screen of NIBP settings, select Cycle option and set as STAT, the STAT measurement will be
taken. This procedure will last for 5 minutes.
5. Stop STAT measurement on the halfway
In the procedure of STAT measurement, press the NIBP key at any time, the measurement will be stopped.

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9.3 SpO2 Monitoring


9.3.1 Measuring Principle
Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its
density or concentration. When the light with certain wavelength emits on human tissue, the measured
intensity of light after absorption, reflecting and attenuation in tissue can reflect the structure character
of the tissue by which the light passes. Due to that oxygenated hemoglobin (HbO2) and deoxygenated
hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light
(600nm~1000nm wavelength), by using these characteristics, SpO2 can be determined. SpO2 measured
by this monitor is the functional oxygen saturation -- a percentage of the hemoglobin that can transport
oxygen. In contrast, hemoximeters report fractional oxygen saturation – a percentage of all measured
hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.

9.3.2 SpO2 Measurement Restrictions (interference reason)


1. The fingers should be properly placed (see the attached illustration of this instruction manual), or else it may
cause inaccurate measurement result.
2. Make sure that capillary arterial vessel beneath the finger is penetrated through by red and infrared lights.
3. The SpO2 sensor should not be used at a location or limb tied with arterial or blood pressure cuff or receiving
intravenous injection.
4. Do not fix the SpO2 sensor with adhesive tape, or else it may result in venous pulsation and consequential
inaccurate measurement result of SpO2.
5. Make sure the optical path is free from any optical obstacles like adhesive tape.
6. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared
heater, and direct sunlight etc.
7. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
8. Please do not use the SpO2 sensor when having the MRI, or burn may be caused by faradism.
9. Always observe the plethysmogram (waveform), which is auto-scaled within the range of 100. The SpO2
reading may be unlikely true when the waveform is not smooth or irregular. If in doubt, rely on your clinical
judgment, rather than the monitor readout
10. A functional tester can not be used to assess the accuracy of the pulse oximeter monitor or a SpO2 sensor.
However, a functional tester, such as SpO2 simulator can be used to check how accurately a particular pulse
oximeter is reproducing the given calibration curve. Before testing the oximeter by a functional tester, please
firstly ask the manufacturer which calibration curve is used, if necessary, request the manufacturer for its
dedicated calibration curve and download it into the tester.
Clinical Limit
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood stream of subject is required.
For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular
contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will be more
sensitive to interference.
2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid
indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin,
and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.
3. The drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed
for serious error of SpO2 measurements.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, the
measurement result of some patients with serious anemia may also present as good SpO2 value.

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9.4 Respiration Monitoring

9.4.1 Measuring Principle


The air will be filled into alveolus or be expelled during respiration, and the chest’s volume changes with this
process. Because the conductivity of air is lower than body tissues, the chest’s impedance will be changed by the
inflation. With this specialization, the respiration can be monitored through putting safe current into body and
measuring the change of voltage between the electrodes. The product will transmit the high-frequency current
whose frequency is much higher than ECG frequency (but with the safe current limit) to the ECG electrodes (placed
at the both sides of chest), which can be detect ECG signal and chest’s impedance at the same time, and the
respiratory rate will be measured through impedance method by the software. So the additional electrodes for
respiratory measurement are unnecessary.

9.4.2 Factors affecting respiration monitoring


— Place the white (RA) and red (LL) electrodes on the cross, if the line between two electrodes in liver area or
heart area, the artificial error may occur.
— Respiration monitoring doesn’t support monitoring the patient who do much movement, or may lead to wrong
alarm.

9.5 Temperature Monitoring


The sensor is thermo-resistor type (25℃ 5kΩ) and is supplied with constant micro current. Calculating the
temperature of measured part through measuring the voltage. There is a period responding time, so the accurate
temperature value display after a while. The temperature monitoring can be divided into two measuring method:
measure through body surface temperature and through the temperature inside the body cavity (placed in mouth or
anus).

Normal value: body surface: 36.5℃~37℃; inside body cavity: 36.5℃~37.7℃

Notes:

¾ Attach the TEMP transducer to the patient; generally if the TEMP transducer and skin doesn’t contact closely, the
measured value becomes lower, so for those who have requirement for temperature, add a proper martial to
transducer and fix it with adhesive tape to make them contact firmly.

¾ Especially for pediatric patient, they like sports, pay more attention to the transducer fixing.

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9.6 CO2 Monitoring


9.6.1 Measuring Principle
The principle is based on the fact that CO2 molecules absorb infrared light energy of specific wavelengths, with the
amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a
gas sample containing CO2, the electronic signal from a photodetector (which measures the remaining light energy), can
be obtained. This signal is then compared to the energy of the IR source, and calibrated to accurately reflect CO2
concentration in the sample. To calibrated, the photodetector’s response to a known concentration of CO2 is stored in the
monitor’s memory.
The monitor determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these
gases.EtCO2 is display as a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In
addition, a CO2 waveform (capnogram) may be displayed which is a valuable clinical tool that can be used to assess
patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time
interval between detected breaths.

9.6.2 Mainstream vs. Sidestream Sampling


Mainstream CO2 sensors are placed at the airway of an intubated patient, allowing the inspired and expired gas to pass
directly across the IR light path. The major advantages of mainstream sensors are fast response time and elimination of
water traps.
Sidestream CO2 sensors are located away from the airway, requiring a gas sample to be continuously aspirated from the
breathing circuit and transported to the sensor by means of a pump. This type of system is needed for non-intubated
patients.
When using mainstream CO2 sensors, check the window for the patient secretions pooled on periodically. Because that
condition may affect the accuracy of the measurement or even make the sensor not work.
When using sidestream CO2 sensors, there is a water trap or a part of the sampling tube with dehumidifying function.
Please periodically check the flow sensor and tubing for excessive moisture or secretion buildup.

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Chapter 10 Troubleshooting
Note: In case of trouble of this machine in service, follow the instructions below to eliminate the problem first. If the
attempt fails, contact the dealer in your local area or the manufacturer.

 Do NOT open the monitor cabinet without permission

10.1 No Display on the Screen


Shut down the machine and unplug the power cable. Use a universal meter to check if the outlet has proper voltage, if
the power cable is in good condition, and if the power cable is properly connected with this apparatus or outlet. Remove
the fuse from the back cover of this machine, and make sure it is in good condition.

10.2 Excessive ECG Signal Interference or too Thick Baseline


1. Check if the plate electrodes are properly located, and if valid plate electrodes are used.

2. Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires are
broken.

3. Make sure the mains outlet has standard grounding wire.

4. Check if the grounding wire of the apparatus properly grounded.

10.3 No Blood Pressure and Pulse Oxygen Measures


1. Check if the blood pressure cuff is properly wrapped around the arm according to the operating instructions, if the
cuff leaks, and if the inlet is closely connected with the NIBP jack on the side panel. Check if the indicator of the
pulse oxygen sensor flashes and if the pulse oxygen probe is properly connected to the SpO2 jack on the side panel.
2. If the problems still exist, please contact the manufacturer.

10.4 System Alarm


1. When the parameter value is higher or lower than the alarm limits, the alarm will ring. Please check whether the
alarm limit value is proper or the condition of the patient.

2. Leads off. Please check the connection of the leads.

3. Probe off. Please check the connection of the probes.

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User manual for Patient Monitor

Chapter 11 Maintenance

In case of trouble of this machine in the service, follow the instructions below to eliminate the problem first. If the
attempt fails, refer to the dealer in your local area or the manufacturer.

11.1 Service and Examination


11.1.1 Daily Examination
Before using the monitor, the checks below should be carried out:
„ Check the monitor for any mechanical damage;
„ Inspect the exposed parts and the inserted parts of all the leads, and the accessories;
„ Examine all the functions of the monitor that are likely to be used for patient monitoring, and ensure that it is
in good working condition;
„ Make sure that the monitor is grounded properly.
„ Pay close attention to the fluctuation of the local power supply voltage. A manostat is recommended when
necessary.
In case any indication of damage about the function of the monitor is detected and proven, it is not allowed to apply it to
the patient for any monitoring. Please contact the local dealer or our company, and we are to offer the best solution as
soon as possible for your satisfaction.

11.1.2 Routine Maintenance


After each maintenance or the yearly maintenance, the monitor can be thoroughly inspected by qualified personnel,
including function and safety examinations. The designed life of this monitor is 5 years. In order to ensure its long
service life, please pay attention to the maintenance.
0 If the hospital fails to carry out a satisfactory maintenance program about the monitor, it may get
disabled and harm the patient’s safety and health.
0 In case of ECG leads damage or aging, please replace the lead.
0 If there is any indication of cable and transducer damage or they deteriorate, they are prohibited from
any further use.
 The adjustable units in the monitor such as potentiometer are not allowed to adjust without permission to
avoid unnecessary failures that affect normal application.
 It is recommended to use the battery once a month to ensure its strong power supply capacity and long
service life, and recharge it after run out of the power volume.

11.2 Battery Maintenance


0 Please pay attention to the polarity of battery, do NOT insert it into battery compartment with reversed
polarities;
0 Do NOT use the batteries manufactured by other companies, if being inserted, the device will may be
damaged;
0 In order to avoid damaging the battery, do NOT use other power supply device to charge the battery;
0 After battery ageing phenomenon occurring, do NOT throw the battery into fire to avoid explosion risk.
0 Do not hit or strike it with force;

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0 Do not use this battery on other devices;


0 Do not use this battery below -10℃ or above 40℃;
0 Dispose of the battery, the local law should be followed.
 In order to maintain battery supply time and prolong battery lifetime, please charge the battery every
one or two months if don’t use battery for a long time. And do charge battery at least 12-15 hours every
time. Before connect to AC, do start monitor with battery’s power supply, until battery power is used up
and monitor turn off automatically, then connect monitor to AC and have it charged for 12-15 hours
continuously. The speed of charge will be the same no matter whether the monitor is working or not. The
reason why discharge the battery before charge is to avoid the decrease of capacity caused by battery’s
memory effect. If the monitor won’t be used for a long time, do have it charged fully before
conservation.
 When starting the monitor by battery power only which is short of supply, monitor will turn off
automatically. In order to avoid the damage to battery caused by excessive discharge, please pay
attention to following. After monitor turns off automatically, there is still small drain current inside
battery, so it is suggested that user should press the power button again to cut off the power supply. If
battery keeps in a state of small drain current, battery will be damaged and can’t be repaired because of
excessive discharged.
 If battery is damaged, please replace with same type and specification battery marked by “CCC” or
“CE” in time, or contact the company directly.

11.3 Cleaning, Sterilization and Disinfection


0 Switch off the monitor and disconnect the power cable before cleaning.
„ Kept the monitor from dust.
„ It is recommended to clean the outer shell and screen of the monitor to keep it clean. Only non-corrosive
cleanser such as clear water is permitted.
„ Wipe the surface of the monitor and transducers with an alcohol impregnated wipe, and dry it with dry and
clean wipe or simply air-dry.
„ This monitor can be disinfected and sterilized, please clear the monitor first.
0 Do not let the liquid cleanser flow into the connector jack of the monitor to avoid damage.
0 Clean the exterior of the connector only.
 Dilute the cleanser.
 Do not use scrub materials.
 Do not let any liquid flow into the shell or any parts of the monitor.
 Do not let the cleanser and disinfectant stay on its surface.
 Do not perform high pressure sterilization to the monitor.
 Do not put any parts of the monitor or its accessories in the liquid.
 Do not pour the disinfector on its surface while sterilization.
 If the monitor is accidentally wetted it should be thoroughly dried before use. The rear cover can be
removed by qualified service technician to verify absence of water.
 Never use this machine in an environment with inflammable gas.
 Avoid being hit by lightning. The power cable should be plugged into an outlet with grounding wire. Do
not use an outlet with poor condition. If possible, use power supply system with regulator.
 It must be used in a clean environment protected against shock. Keep it away from corrosive substances,
explosive substances, high temperature and dampness.

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 If it is installed in a cabinet, make sure the installation allows for good ventilation, and easy maintenance,
observation and operation.

11.4 Cleaning, Sterilization and Disinfection of Accessories


It is recommended to clean the accessories (including sensor, leads and plugs) with a piece of gauze which has been
soaked in 75% Alcohol or 70% Ispropanol before use.
0 Do not use damaged accessories.
0 Accessories can not be entirely immerged into water, liquor or cleanser.
0 Do not use radial, steam or epoxyethane to disinfect accessories.
0 Do wipe off the remained alcohol or ispropanol on the accessories after disinfection, for good
maintenance can extend the life of accessories.

11.5 Storage
If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging, which shall be kept
in a dry and good ventilation place free from dust and corrosive gases
Storage environment: ambient temperature: -20~60°C
relative humidity: 10%~95%
atmosphere: 53kPa~106kPa

11.6 Transportation
This monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms. Do not
hit or drop it with force.

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Chapter 12 Appendix

12.1 Alarm Information


Alarm Information Descriptions
Over HR limit
Over RR limit
Over TEMP limit
Over SpO2 limit
Over PR limit
Over NIBP SYS limit The related parameter value exceeds the preset high/low
Over NIBP DIA limit alarm limit.
Over NIBP MAP limit
Over ST limit
Over NIBP PR limit
Unable to detect HR ECG cable and leads are connected to monitor and patient
well, but HR is unable to be detected. It may caused by
inconformity HR signal.
Unable to detect SpO2 SpO2 probe is connected to monitor and patient well, but
SpO2 is unable to be detected. It may be caused by inconformity
SpO2 signal.
The battery capacity will exhaust Low battery voltage
Lead Off The ECG electrodes or cable fell off
Probe Off SpO2 probe fell off

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12.2 Default Alarming Values and Setup Range


The default alarming value:

Mode Adult Infant Neonate


Parameter
High Limit 180 bpm 200 bpm 220 bpm
Heart Rate
Low limit 40 bpm 50 bpm 50 bpm
High Limit 40 rpm 50 rpm 60 rpm
Respiration
Low limit 10 rpm 10 rpm 10 rpm
High limit 39℃ 39℃ 39℃
Temperature
Low limit 35℃ 35℃ 35℃
High Limit 180 mmHg 130 mmHg 110 mmHg
Systolic
Low limit 60 mmHg 50 mmHg 50 mmHg
High Limit 120 mmHg 90 mmHg 90 mmHg
NIBP Diastolic
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 160 mmHg 110 mmHg 100 mmHg
MAP
Low limit 50 mmHg 40 mmHg 30 mmHg
High limit 100% 100% 100%
SpO2
Low limit 90% 85% 85%
High limit 180 bpm 200 bpm 220 bpm
Pulse Rate
Low limit 40 bpm 50 bpm 50 bpm
High Limit +1.00mV +1.00mV +1.00mV
ST Segment
Low Limit -1.00mV -1.00mV -1.00mV
Temperature Difference Range 2℃ 2℃ 2℃
High limit 200mmHg 160mmHg 140mmHg
SYS
Low limit 10mmHg 10mmHg 10mmHg
Arterial High limit 200mmHg 160mmHg 140mmHg
DIA
Pressure Low limit 10mmHg 10mmHg 10mmHg
High limit 200mmHg 160mmHg 140mmHg
MAP
Low limit 10mmHg 10mmHg 10mmHg
High limit 120mmHg 100mmHg 90mmHg
SYS
Low limit 10mmHg 10mmHg 10mmHg
Pulmonary High limit 120mmHg 100mmHg 90mmHg
Artery DIA
Pressure Low limit 10mmHg 10mmHg 10mmHg
High limit 120mmHg 100mmHg 90mmHg
MAP
Low limit 10mmHg 10mmHg 10mmHg
High limit 30mmHg 30mmHg 30mmHg
SYS
Low limit 0mmHg 0mmHg 0mmHg
Central High limit 30mmHg 30mmHg 30mmHg
Venous DIA
Pressure Low limit 0mmHg 0mmHg 0mmHg
High limit 30mmHg 30mmHg 30mmHg
MAP
Low limit 0mmHg 0mmHg 0mmHg
Respiration High limit 40 rpm 50 rpm 60 rpm
Rate Low limit 10 rpm 10 rpm 10 rpm
High limit 70 mmHg 70 mmHg 70 mmHg
CO2 EtCO2
Low limit 10 mmHg 10 mmHg 10 mmHg
High limit 10 mmHg 10 mmHg 10 mmHg
InsCO2
Low limit 0 mmHg 0 mmHg 0 mmHg

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The high and low limits setting range:

Mode Adult Infant Neonate


Parameter
High limit 1~350bpm 1~350bpm 1~350bpm
Heart Rate
Low limit 0~349bpm 0~349bpm 0~349bpm
High limit 1~120rpm 1~150rpm 1~150rpm
Respiration
Low limit 0~119rpm 0~149rpm 0~149rpm
High limit 0.1~60°C 0.1~60°C 0.1~60°C
Temperature
Low limit 0~59. 9°C 0~59. 9°C 0~59. 9°C
High limit 30~280 mmHg 30~200 mmHg 30~135 mmHg
Systolic
Low limit 29~279 mmHg 29~199 mmHg 29~134 mmHg
High limit 11~232 mmHg 11~150 mmHg 11~100 mmHg
Diastolic
Low limit 10~231 mmHg 10~149 mmHg 10~99 mmHg
High limit 21~242 mmHg 21~165 mmHg 21~110 mmHg
Mean
Low limit 20~241 mmHg 20~164 mmHg 20~109 mmHg
High limit 1~100% 1~100% 1~100%
SpO2
Low limit 0~99% 0~99% 0~99%
High limit 1~300bpm 1~350bpm 1~350bpm
Pulse Rate
Low limit 0~299bpm 0~349bpm 0~349bpm
High Limit -2.49Mv~+2.49mV -2.49mV~+2.49mV -2.49mV~+2.49mV
ST Segment
Low Limit -2.49mV~+2.49mV -2.49mV~+2.49mV -2.49mV~+2.49mV
Temperature Difference 0.0~5.0℃ 0.0~5.0℃ 0.0~5.0℃
High limit (1~250)mmHg (1~250)mmHg (1~250)mmHg
Systolic
Low limit (0~249)mmHg (0~249)mmHg (0~249)mmHg
Arterial High limit (1~250)mmHg (1~250)mmHg (1~250)mmHg
Diastolic
Pressure Low limit (0~249)mmHg (0~249)mmHg (0~249)mmHg
High limit (1~250)mmHg (1~250)mmHg (1~250)mmHg
Mean
Low limit (0~249)mmHg (0~249)mmHg (0~249)mmHg
High limit (1~120)mmHg (1~120)mmHg (1~120)mmHg
Systolic
Low limit (0~119)mmHg (0~119)mmHg (0~119)mmHg
Pulmonary High limit (1~120)mmHg (1~120)mmHg (1~120)mmHg
Artery Diastolic
Pressure Low limit (0~119)mmHg (0~119)mmHg (0~119)mmHg
High limit (1~120)mmHg (1~120)mmHg (1~120)mmHg
Mean
Low limit (0~119)mmHg (0~119)mmHg (0~119)mmHg
High limit (-9~40)mmHg (-9~40)mmHg (-9~40)mmHg
Systolic
Low limit (-10~39)mmHg (-10~39)mmHg (-10~39)mmHg
Central High limit (-9~40)mmHg (-9~40)mmHg (-9~40)mmHg
Venous Diastolic
Pressure Low limit (-10~39)mmHg (-10~39)mmHg (-10~39)mmHg
High limit (-9~40)mmHg (-9~40)mmHg (-9~40)mmHg
Mean
Low limit (-10~39)mmHg (-10~39)mmHg (-10~39)mmHg
Respiration High limit (1~120)rpm (1~150)rpm (1~150)rpm
Rate Low limit (0~119)rpm (0~149)rpm (0~149)rpm
High limit (1~100)mmHg (1~100) mmHg (1~100) mmHg
CO2 EtCO2
Low limit (0~99)mmHg (0~99) mmHg (0~99) mmHg
High limit (1~30)mmHg (1~30) mmHg (1~30) mmHg
InsCO2
Low limit (0~29)mmHg (0~29) mmHg (0~29) mmHg

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12.3 Abbreviation of Arrhythmia


1. ECG TACHY
2. ECG BRADY
3. ECG VPCEST
4. MISS BEAT
5. VE EARLY
6. SVE EARLY
7. VE COUPLET
8. SVE COUPLET
9. VE RUN
10. SVE RUN
11. VE SHORT RUN
12. SVE SHORT RUN
13. VE BIGEMINY
14. SVE BIGEMINY
15. VE TRIGEMINY
16. SVE TRIGEMINY
17. VE INSERT
18. SVE INSERT
19. VE RONT
20. SVE RONT

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12.4 Status/Error during NIBP Monitoring


“Cuff error” —cuff is not wrapped correctly, or is not connected

“Air leak” —Air moving part, tube or the cuff leak air.

“Pressure error” —Unstable cuff pressure or tangled cuff tubing

“Signal weak” —Very weak signal because of the cuff, or the patient has very weak pulse

“Over extent” —The measurement range exceeds 255 mmHg (Infant patient over 135 mmHg)

“Over motion” —The repeated measurement due to moving, excessive noise during the stepping inflation and

measuring pressure and pulse, e.g. during patient shaking motion

“Signal overflow” —Blood pressure amplifier overflow due to excessive movement

“Leak in gas run” —Leaking during the pneumatic device testing

“System error” —Abnormal condition of CPU, such as register overflow, divided by zero

“Adult” —The blood pressure measuring now is in adult mode. In this case, it is not allowed to monitoring

infant or neonatal patient. Otherwise, there may be serious danger to the infant monitored.

“Infant” —The blood pressure module is now worked in infant measuring mode.
“PROBE OFF” —SpO2 probe fell off
“LEADS OFF” —The ECG electrodes or cable fell off

“LEARNING” —Learning arrhythmia for 15 seconds

“DEMO” —The monitor is displaying the demo waveforms, which are generated by the monitor itself.

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12.5 Status/Error during CO2 Monitoring


Suggested Message/Response Description
“Sensor Over Temp” The sensor temperature is greater than 40 °C.
Make sure sensor is not exposed to extreme heat (heat
lamp, etc.). If error persists, return sensor to factory for
servicing.
“Sensor Faulty” One of the following conditions exist:
Check that the sensor is properly plugged in. Reinsert Source Current Failure,
or reset the sensor if necessary. If error persists, return EEPROM Checksum Faulty,
sensor to factory for servicing Hardware Error

No Parameter Message Barometric Pressure and/or gas compensations have not been
The host must set the Barometric Pressure and set since power on. For CO2 to be calculated with the stated
compensations to clear this error; no user intervention accuracy, these values should be set whenever the sensor is
should be required. plugged in.

“Module in Sleep Mode” This bit is set when sensor has been placed in sleep mode.
“Zero In Progress “ A Module Zero is currently in progress.
One of the following conditions exist:
“Sensor Warm Up”
Sensor under temperature
This error condition is normal at startup. This error
Temperature not stable
should clear when the warm up is complete.
Source Current unstable
“Check Sampling Line” This error occurs whenever the pneumatic pressure is outside
Check that the sampling line is not occluded or kinked. the expected range.
“Zero Required” One of the following conditions exist:
To clear, check airway adapter and clean if necessary. Zero Required;
If this does not correct the error, perform an adapter Zero Required: Zero Error
zero. If you must adapter zero more than once, a
possible hardware error may exist.
The value being calculated is greater than the upper CO2 limit
“CO2 Out of Range”
(150 mmHg, 20.0 kPa, or 19.7 %). The maximum value output
If error persists, perform a zero. is the upper CO2 limit.
Usually caused when the airway adapter is removed from the
“Check Airway Adapter” sensor or when there is an optical blockage on the windows of
To clear, clean airway adapter if mucus or moisture is the airway adapter. May also be caused by failure to perform
seen. If the adapter is clean, perform a Capnostat zero. sensor zero to when adapter type is changed.

This is prompted if the CO2 sensor is not ready for a Capnostat Zero.
If the “Zero Required” and this massage both prompt message both
The Sensor promptone or more of the following conditions may exist:
not Ready • Breaths detected
• Temperature is not stable
• Source Current unstable
• In sleep mode.

Zero in already progress Normal zero calibration is in already progress.


Zero Fault and Breaths Detected Zero attempted and breaths have been detected in the last 20
seconds.
Zero Ok Zero calibration is successful

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12.6 Typical Pressures and CO2 Readings at Altitudes

Barometric EtCO2 Reading


Altitude
Pressure(mmHg) (%) (mmHg)
0m 760 5 38.0
70m 754 5 37.7
100m 751 5 37.5
200m 743 5 37.1
1500m 641 5 32.0
3000m 537 5 26.8
5000m 420 5 21.0

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12.7 Accessories List


Part No. Part Name Remark
15010513 ECG cable
5101-0101310 ECG electrode
15044051 Adult SpO2 Finger clip Sensor
15044061 Adult SpO2 Finger rubber Sensor Optional
15044041 Pediatric SpO2 Finger clip Sensor Optional
15024402 Adult NIBP cuff(25~35cm)
15021402 Small-sized Pediatric NIBP Cuff Optional
15022402 Middle-sized Pediatric NIBP Cuff Optional
15023402 Large-sized Pediatric NIBP Optional
15084120 Skin TEMP probe
15100420 CO2 Mainstream sensor Optional for mainstream
15100411 Adult airway adapter Optional for mainstream
15100421 Pediatric airway adapter Optional for mainstream
15100410 CO2 Sidestream sensor Optional for sidestream
15100130 Sampling line kit Optional for sidestream
15100214 Extending airway tube Optional for sidestream
15100210 Wye connector Optional for sidestream
2903-0000000 Power cord
900093 Net wire

For more information regarding the accessories, please contact your local sales representative or the
manufacturer.

Note: Part no. is subject to change without prior notice, please refer to the label of parts or packlist.

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12.8 Instructions for SpO2 Probe


Instructions for Pediatric SpO2 Finger Clip Sensor
Intended Use
When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for pediatric patients
weighing between 10~40kg.

Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.
Instructions for Use
1) With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the finger tip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or is
not available, other fingers can be used.
2) Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
3) Spread open the rear tabs of the sensor to provide even force over the length of the pads (B).
4) The sensor should be oriented in such a way that the cable is positioned along the top of the hand (C).
5) Plug the sensor into the
oximeter and verify proper
operation as described in
the user manual.
6) Inspect the monitoring site
every 1~2 hours for skin integrity.
7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings
1) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poor blood perfusion in the finger, extreme
finger sizes or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the
sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the
ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently
with some patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.

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Instructions for Adult SpO2 Finger Rubber Sensor


Intended Use
When used with a compatible patient monitor or a pulse oximeter device, this SpO2 sensor is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients weighing
greater than 50kg.

Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use


1) Hold the sensor with its opening towards the patient’s index finger (A). The sensor should be oriented in such a
way that the sensor side with a finger tip sign is positioned on the top.
2) Insert the patient’s index finger into the sensor until the fingernail tip rests against the stop at the end of the
sensor. Adjust the finger to be placed evenly on the middle base of the sensor. Direct the cable along the top of
the patient’s hand. Apply adhesive tape to secure the cable (B). If an index finger cannot be positioned
correctly, or is not
available, other fingers
can be used.
3) Plug the sensor into the
oximeter and verify
proper operation as
described in the user
manual.
4) Inspect the monitoring site every 1~2 hours for skin integrity.

Cleaning & Disinfection


Unplug the sensor before cleaning or disinfecting. Surface-clean sensor and cable with a soft gauze pad by saturating
it with a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings
1) This sensor is for use only with compatible patient monitors or pulse oximeter devices. Use of this sensor with
instruments other than compatibles may result in improper performance.
2) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger sizes
or improper placement of the sensor.
3) The sensor site must be checked for skin integrity at least every 1~2 hours. Because individual skin condition
affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor to another
finger.
4) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse. Do not use the sensor
during MRI scanning.
5) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
6) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
7) Do not use the sensor if the sensor or the sensor cable appears damaged.

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Instructions for Adult SpO2 Finger Clip Sensor


Intended Use

When used with a compatible patient monitor or a pulse oximeter device, the sensor is intended to be used for
continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring for patients weighing
greater than 40kg.

Contraindications

This sensor is contraindicated for use on active patients or for prolonged use.

Instructions for Use

1) With the upper and lower jaws open, place an index finger evenly on the base of the clip. Push the finger tip
against the stop so that it is over the sensor window (A). If an index finger cannot be positioned correctly, or is
not available, other fingers can be used.
2) Note: When selecting a sensor site, priority should be given to an extremity free of an arterial catheter, blood
pressure cuff, or intravascular infusion line.
3) Spread open the rear tabs of the sensor to provide even force over the length of the pads (B).
4) The sensor should be
oriented in such a way
that the cable is
positioned along the top
of the hand (C).
5) Plug the sensor into the oximeter and verify proper operation as described in the user manual.
6) Inspect the monitoring site every 1~2 hours for skin integrity.
7) Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as
70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Warnings

1) Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient
motion, fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger sizes
or improper placement of the sensor.
2) Using the sensor in the presence of bright lights may result in inaccurate measurements. In such cases, cover the
sensor site with an opaque material.
3) The sensor must be moved to a new site at least every 3 hours. Because individual skin condition affects the
ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently
with some patients. If skin integrity changes, move the sensor to another site.
4) Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation may lead to inaccurate
saturation measurements.
5) Do not immerse sensor as it causes short.
6) Do not use NIBP or other constructing instruments on same appendage as sensor for blood flow interrupted by
NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.
7) Do not use the sensor or other oximetry sensors during MRI scanning.
8) Carefully route cables to reduce the possibility of patient entanglement or strangulation.
9) Do not alter or modify the sensor. Alterations or modifications may affect performance or accuracy.
10) Do not use the sensor if the sensor or the sensor cable appears damaged.

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User manual for Patient Monitor

Our company offers a 6-momth warranty against manufacturing defects for the SpO2 sensors
mentioned above in its undamaged condition.

If you have any question regarding any of SpO2 sensor instructions, please contact
your local dealer.

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Heal Force Bio-Meditech Holdings Group
Nison Instrument (Shanghai)Ltd.

Address 15F., No.2 Hua Shan Road, Shanghai 20040, P.R. China
Tel +86 21-6272 8646
Fax +86 21-6271 0529
E-mail export@healforce.com
Website www.healforce.com

Version 1.2
Revised date August 2, 2012

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