Classic-120plus V1.2 Manual Usuario
Classic-120plus V1.2 Manual Usuario
Classic-120plus V1.2 Manual Usuario
Classic-120plus
User Manual
(Version 1.2)
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.
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.
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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.
systems requirements.
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 Each time the monitor is used, check the alarm limits to ensure that they are
appropriate for the patient being monitored.
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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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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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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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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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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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.
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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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3.2 Appearance
3.2.1 Front Panel
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.
8. Print: Click it to print out different waveforms under different system states.
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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:
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 CF applied part and applicable during the defibrillator is used.
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CE mark
Serial number
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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:
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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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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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.
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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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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The symbol indicates that the cable and accessories are designed to have special protection against electric
shocks, and is defibrillator proof.
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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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.
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Patient Monitor has two TEMP probes to measure different body temperature.
Connecting methods:
Fig.3.9 Fig.3.10
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Power Indicator
Open button
Error Indicator
Paper cartridge
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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
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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.
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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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4.2.3 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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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.
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.
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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.
☞ 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.
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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.
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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
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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.
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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
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When the groups of data exceed one screen, please use the ↑ and ↓ arrow or rotate Navigation knob to scroll the data.
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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.
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.
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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.
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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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.
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Extending airway tube for connecting to sampling tube (Single patient use)
Wye Connector
On-air Connector
Adapter
(2) Nasal Sidestream Cannula Kits
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Sensor cable
Adapter
CO2 sensor
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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.
Waveform area
5th waveform: CO2 waveform. It can be respiration waveform or CO2 waveform.
Data area
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Note: only when the setting item “System Menu→SETUP→CO2→Switch”is set as “ON”, CO2 monitoring
function is available.
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Chapter 6 Alarm
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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Note: Visual alarm indicators can not be suspended or removed. Audible alarms may be decreased in volume or
silenced.
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 .
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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7.10 Classification
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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.
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.
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
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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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)
Note: The accessories are subject to change. Detailed items and quantity see the Packing List.
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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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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.
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.
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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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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.
2. Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires are
broken.
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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.
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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.
11.5 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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“Air leak” —Air moving part, tube or the cuff leak air.
“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
“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
“DEMO” —The monitor is displaying the demo waveforms, which are generated by the monitor itself.
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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.
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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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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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Contraindications
This sensor is contraindicated for use on active patients or for prolonged use.
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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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.
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