STAR8000E - Service Manual
STAR8000E - Service Manual
Service Manual
Copyright
Version: B
Statement
Shenzhen Comen Medical Instruments Co., LTD. (“ Comen” or “Comen Company”) possesses the copyright
of the non-published Service Manual, and has the right to handle it as confidential data.This Service Manual
is only used as the reference data for the maintenance.The others have no right to disclose the content of this
Service Manual to any third person.
This manual contains the proprietary information which is protected by copyright law. With copyright
reserved, any person shall not photocopy or duplicate any part of this manual or translate it into any other
language without the prior written permission of Comen Company.
Comen Company shall not assume responsibility for the incidental or consequential damages resulting from
the errors in this manual or from the provision, actual performance and use of this manual. Comen Company
shall not provide the proprietary right vested by patent law to any third party. Comen Company shall not
assume legal responsibility for the legal consequences resulting from violating the patent law and the rights
of any third party.
The content in this manual may be subject to change without further notice.
Return of products
If the products need to be returned to Comen Company, please follow the following steps:
Acquisition of the right to return the goods: Contact the after-sales department of Comen Company, tell it the
number of the instrument made by Comen; this number was printed on the equipment nameplate; if this
instrument number is not legible, the goods returned shall not be accepted. Please specify the instrument
number and production date, and briefly describe the reason for returning the goods.
I
STAR8000E Vital Signs Monitor Service Manual
Content
Chapter 1 Safety ................................................................................................................................................. 1
1.1 Safety Information ................................................................................................................................. 1
1.2 Equipment Symbols .............................................................................................................................. 3
Chapter 2 Warranty and Service.......................................................................................................................... 1
2.1 Warranty Terms..................................................................................................................................... 1
2.2 What is excluded? ................................................................................................................................. 1
2.3 Service Procedure ................................................................................................................................. 2
2.3.1 Fill in the Service Claim Form (SCF) ........................................................................................ 2
2.3.2 Send COMEN the SCF and Select a Solution............................................................................ 2
2.3.3 Obtain the RMA Form ............................................................................................................... 3
2.3.4 Send the Parts to COMEN ......................................................................................................... 4
Chapter 3 Principle Introduction ......................................................................................................................... 1
3.1 STAR8000E Hardware Block Diagram ................................................................................................ 1
3.2 Module Introduction ............................................................................................................................. 1
3.2.1 Main board ................................................................................................................................ 1
3.2.2 7 Prameter ECG Board ............................................................................................................. 2
3.2.3 7 Parameter NIBP Board .......................................................................................................... 3
3.2.4 AC Power Supply Module ....................................................................................................... 4
3.2.5 DC Power Supply Board.......................................................................................................... 5
3.2.6 Key Board .............................................................................................................................. 6
3.2.7 SPO2 Module............................................................................................................................. 6
3.2.8 7 parameter IBP Board ........................................................................................................... 8
3.2.9 Side Connecting Board ........................................................................................................... 9
Chapter 4 Troubleshooting .................................................................................................................................. 1
4.1 Introducion ............................................................................................................................................. 1
4.2 Part Replacement .................................................................................................................................. 1
4.3 Monitor Status Check............................................................................................................................ 1
4.4 Software Version Check ........................................................................................................................ 1
4.5 Technical Alarm Check .......................................................................................................................... 2
4.6 Troubleshooting Guide.......................................................................................................................... 2
4.6.1 Power On/Off Failures ............................................................................................................... 2
4.6.2 Display Failures ......................................................................................................................... 3
4.6.3 Battery Problem ......................................................................................................................... 3
4.6.4 SPO2 Failures ............................................................................................................................ 4
4.6.5 NIBP Failures............................................................................................................................. 4
4.6.6 ECG Failures............................................................................................................................... 5
4.6.7 SpO2 Failures ............................................................................................................................. 6
4.6.8 RESP Failures ............................................................................................................................. 7
4.6.9 IBP Module Defective ............................................................................................................ 7
4.6.10 TEMP Module Defective ........................................................................................................ 8
4.6.11 EtCO2 Failures ..................................................................................................................... 9
4.6.12 Button and Knob Failures ........................................................................................................ 9
4.6.13 Recorder Failures ................................................................................................................. 10
4.6.14 Network Related Problems ................................................................................................. 10
II
STAR8000E Vital Signs Monitor Service Manual
4.6.15 Software Upgrade Problems ..................................................................................................11
4.6.16 Technical Alarm Messages .................................................................................................11
Chapter 5 Software Upgrade .............................................................................................................................12
5.1 Tools ..................................................................................................................................................12
5.2 Preparation before Upgrade System Software ....................................................................................12
5.3 System Software Upgrade ...................................................................................................................12
Chapter 6 Performance Verification.................................................................................................................... 1
6.1 NIBP Test.............................................................................................................................................. 1
6.1.1 NIBP Leakage Test ...................................................................................................................... 1
6.1.2 NIBP Pressure Calibration ......................................................................................................... 2
6.2 Spo2 Test .............................................................................................................................................. 2
6.3 IBP Test ................................................................................................................................................ 3
6.3.1 BP \Performance Test ................................................................................................................ 3
6.3.2 IBP Pressure Calibration .............................................................................................................. 3
6.4 Sidestream and Mainstream CO2 Module Test .................................................................................... 3
6.5 ECG Test................................................................................................................................................ 4
6.5.1 ECG Performance Test ................................................................................................................ 4
6.5.2 ECG Calibration ......................................................................................................................... 4
6.6 RESP Performance Test ......................................................................................................................... 5
6.7 TEMP Test ............................................................................................................................................ 5
Chapter 7 Disassembling the Monitor................................................................................................................. 6
7.1 Who Should Perform Repairs ............................................................................................................... 6
7.2 Removing the Battery ............................................................................................................................ 2
7.3 Separating the Front and Rear Housing ................................................................................................ 2
7.4 Removing Main Board ........................................................................................................................... 3
7.5 Removing the Key Board ....................................................................................................................... 4
7.6 Removing the Knob Encoder ................................................................................................................. 4
7.7 Removing the LCD Screen ..................................................................................................................... 5
7.8 Removing the Alarm LED Board............................................................................................................. 5
7.9 Removing the 7 Parameter NIBP Board ................................................................................................ 6
7.10 Removing the SpO2 board .................................................................................................................... 6
7.11 Removing the Power Supply Module................................................................................................... 7
7.12 Removing the Speaker and Side Panel ................................................................................................ 8
7.13 Removing the ECG board ..................................................................................................................... 9
7.14 Removing the Recorder ...................................................................................................................... 9
III
Chapter 1 Safety
Warning
Caution
To indicate potential danger or unsafe operation. If not avoided, it may lead to mild
personal injury, product malfunction, damages or property loss. It may also give rise to
more severe harm.
Attention
Warning
This monitor is used for monitoring the clinical patients, so only the doctors and nurses
who are qualified through training can use this monitor.
Do not posit the equipment to make it difficult to operate the power plug which uses to
isolate the equipment circuits electrically from the supply mains.
There is no alarm system for the monitor, only provides fault code for reference. And
also it is not suitable for continuous monitoring, please pay close attention to patient’s
condition avoid any delay of the illness.
Before use, the user shall check whether this instrument and its accessories can work
normally and safely.
Please assure the continuous power supply when monitor patient, the data will be lost
when unexpectedly lose power.
This instrument can only be connected to a power socket with protective grounding. If
Chapter 1-1
Safety
the power socket is not connected to grounding conductor, do not use this socket, but use
the rechargeable batteries for power supply.
l Do not open the shell of this instrument to avoid the possible electric shock hazard. The
maintenance and upgrading of this monitor must be conducted by the service personnel
trained and authorized by Comen Company.
l The disposal of packaging materials shall comply with the local laws and regulations or
the waste disposal rules and regulations of the hospital. The packaging materials must
be placed away from the children.
l Do not use this instrument at the place where there are flammable articles such as
anesthetic to prevent explosion or fire from happening.
l Please carefully install the power lines and the cables for various accessories to avoid the
patient from being constricted or suffocated or the cables from getting entangled and
keep the patient free from electrical interference.
l Do not use mobile phone near the monitor, because the mobile phone will generate a
very strong radiation field and disturb the functions of the monitor.
l When the monitor is used with HF surgical equipment, the transducer and the cables
must be avoided conductive connection to the HF equipment to protect against burns to
the patient.
l The equipment connected with the monitor shall form an equipotential body (the
protective grounding wire is effectively connected).
l When the monitor is shared with the electrosurgery unit, the user (doctor or nurse) shall
ensure the patients safety.
l The electromagnetic field will affect the performance of this instrument, so the use of the
other equipment near this instrument must meet corresponding EMC requirements. For
example: Mobile phone, X-ray or MRI equipment may be an interference source,
because they will transmit high-strength electromagnetic radiation.
l Continuous and prolonged period of monitoring may increase the risk of undesirable
changes in the skin characteristics, such as extremely sensitive, reddening, blistering, or
even pressure necrosis etc.
Caution
To avoid damage to this instrument and guarantee patient safety, please use the
accessories designated in this instruction manual.
Please properly install or move this instrument and prevent the instrument from being
Chapter 1-2
Safety
damaged due to fall, collision, strong vibration or other external mechanical forces.
l Before the instrument is switched on, please confirm whether the power supply used
meets the requirements for power supply voltage and frequency designated in the
nameplate label or in the instruction manual of this instrument.
l When this instrument and its accessories are about to exceed the service life, they must
be disposed of according to local relevant laws and regulations or the rules and
regulations of the hospital.
l Disposal accessories only can be used for one time in case of performance reduction or
cross infection.
l Please take out the battery of the monitor and keep properly if long time no use.
l The monitor resumes normal operation 10s after defibrillation
Attention
Please install the equipment in a place that is convenient for observation, operation and
maintenance.
This instruction manual introduces the product according to the most complete
configurations. The product you have purchased may not possess some configurations or
functions.
Please place this instruction manual near the instrument for easy and timely reference.
Chapter 1-3
Safety
DVI interface
SD card interface
Table 1
Table 2
Chapter 1-4
Chapter 2 Warranty and Service
COMEN provides an 24 months warranty for the warranted products (main unit) and 6 months for the
accessories. The warranty period begins on the date products are shipped to customer. If a customer
promptly notifies COMEN of customer’s warranty claim hereunder, COMEN will either repair, adjust or
replace (with new or exchange replacement parts) COMEN’s products. COMEN warranty that any service it
provides to customers will be performed by trained individuals in a workmanlike manner.
The warranty does not cover for the situations caused by the following condition:
l Malfunction or damage caused by improper use or man-made failure.
l Malfunction or damage caused by unstable or out-of-range power input.
l Malfunction or damage caused by force majeure such as fire and earthquake.
l Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service
people.
l Malfunction or damage caused by use of parts or accessories not approved by COMEN.
l Malfunction of the instrument or part whose serial number is not legible enough.
l Others not caused by instrument or part it.
Chapter 2-1
Warranty and Service
Figure 1
Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and Problem
Phenomena.
COMEN should not have any obligation to take over the case without this information. The form can got
from COMEN’s Service Department.
Figure 2
Chapter 2-2
Warranty and Service
Ø Within Warranty:
There are two options:
1) After receiving the Return Material Authorization (RMA) form from COMEN service department,
customer sends COMEN the defective parts and informs about the shipment tracking number. Then we
will dispatch new part(s) to your confirmed address with confirmed shipping invoice.
2) The customer signs the Declaration Form and sends it back by email or fax. This form is legally
certificated to make sure the customer or end-user will return the defective parts to COMEN on time.
We will, at this option, dispatch the replacement one(s) with confirmed shipping invoice.
Attention
Both Return Material Authorization Form and Declaration Form are offered by COMEN
service department once the SCF is confirmed by service engineer.
COMEN for service, including custom charges. COMEN is responsible for the freight,
insurance & custom charges from COMEN to the customer.
Ø Out of Warranty:
After receiving the RMA form from the service department, the customer sends defective parts to COMEN
in advance. We will analyze the problems and discuss with the customer about either repairing or replacing
the part(s). Once the maintenance fee is invoiced and paid, we will make sure to dispatch good part(s) to the
confirmed address.
Attention
The customer is responsible for any freight & insurance charges for the returned product.
Before the shipment of the materials, the customer must obtain an RMA form from our service department,
in which the RMA number, description of returning parts and shipping instructions are included. The RMA
number should be indicated on the outside of the shipping container.
Attention
COMEN should not have any obligation to the end-user or customer who returns the goods
without the notification by COMEN’s service department. The sender takes full responsibility
for the accounted fee.
Chapter 2-3
Warranty and Service
Chapter 2-4
Chapter 3 Principle Introduction
Figure 4
The main board is the heart of the monitor,it is in charge of connections and communications with other
internal modules.
The main board is the heart of the patient monitor. It implements a series of tasks including input& output
control, data storage and processing, display processing, system control communication management,
printing management and alarming, etc.
The main board comprises the core board and bottom board. The core board is an essential CPU system
Chapter 3-1
Principle Introduction
containing the CPU, FLASH, memory, real time clock, EEPROM, etc. It interfaces to the bottom board only.
The bottom board is in charge of connections and communications with other internal modules
Figure 5
The 7 parameter ECG board is a parameter measurement components, it provides the following functions:
1. 3 or 5 leads ECG and RESP measurement;
2. 2-channel TEMP measurement;
3. Data exchange with the 7 parameter NIBP module.
Chapter 3-2
Principle Introduction
Figure 6
PIN ID J2 J3
Description To NIBP board To ECG interface panel
Working voltage 6.6V,5V,3.3V 5V
Module Function Measure ECG parameter
Table 4
The 7 parameter NIBP board is a parameter measurement components, it provides the following functions:
1. NIBP measurement;
2. SpO2 installation place;
3. IBP installation place;
4. Data exchange with the main board through the serial ports.
Chapter 3-3
Principle Introduction
The power module is located at the back of the patient monitor. The main part of the power module is the
power board, which contains charging & power management, distributed different DC power to main
board , 7-parameter board, USB port, speaker and battery charging.
The AC power module transforms the input power into DC and then forwards them to each component of
the patient monitor. The input power comes from AC source. The patient monitor will run power from the
AC source whenever an AC source is available. If the AC source becomes unavailable, the patient monitor
will automatically switch to the battery power. This does not affect the monitor’s operating status.
Chapter 3-4
Principle Introduction
Description
The DC power module is located at the back of the patient monitor. The main part of the power module is
the power board, which contains charging & power management, distributed different DC power to main
board , 7-parameter board, USB port, speaker and battery charging.
Chapter 3-5
Principle Introduction
The key board, located at the lower part of the monitor’s front panel, button board including knob that can
be pressed, knob can also be rotated both clockwise and counter-clockwise, signals are sent to main board
CPU by the single chip processor on button board. It also controls display of power indicator, AC indicator
and battery charge indicator.
PIN ID J3 J1
Description Button FFC socket Knob socket
Working voltage 18V,12V,5V 5V
Module Function keyboard signal process and sending
There are 3 types of SPO2 modules: COMEN SPO2, Masimo SpO2 and Nellcor SpO2 module.
The SPO2 board implements SPO2 signals collect amplified simulating, relative digital/analog converting
and signal processing.
The pulse extent of optical signal changes during monitoring. SpO2 parameter, pulse rate signal and pleth
waveform will be acquired after calculation. These data will be transmitted to the main board with special
communication protocol.
Chapter 3-6
Principle Introduction
Figure 16
No. Description Working Voltage
2*4pin,SpO2 input socket /
2*5pin,SpO2 module socket 3.3V
Table 12
Table 12
Figure 17
No. Description Working Voltage
2*5pin,SpO2 module socket 3.3V
2*5pin,SpO2 input socket /
Table 13
Chapter 3-7
Principle Introduction
Figure 18
No. Description Working Voltage
2*5pin,SpO2 module socket 3.3V
2*4pin,SpO2 input socket /
PIN ID J8 J9
Description IBP Power Socket IBP Power Socket
Working voltage 5V 5V
Chapter 3-8
Principle Introduction
PIN ID J1 J3 J5 J11
Working / / / /
voltage
Module Collect data from external accessories.
Function
Figure 15
Chapter 3-9
Chapter 4 Troubleshooting
4.1 Introducion
In this chapter, patient monitor problems are listed along with possible causes and recommended corrective
actions. Refer to the tables to check the patient monitor, identify and eliminate the troubles. The troubles we
list here are frequently arisen difficulties and the actions we recommend can correct most problems, but not
all of them. For more information on troubleshooting, contact our International After-sale Dept.
Printed circuit boards (PCBs), major parts and components in the patient monitor are replaceable. Once you
isolate a PCB you suspect defective, follow the instructions in 7Repair and Disassembly to replace the PCB
with a known good one and check that the trouble disappears or the patient monitor passes all performance
tests. If the trouble remains, exchange the replacement PCB with the original suspicious PCB and continue
troubleshooting as directed in this chapter. Defective PCB can be sent to us for repair.
Some troubleshooting tasks may require you to identify the hardware version and status of your patient
monitor.
Some troubleshooting tasks may require you to identify the configuration and software version of your
patient monitor
Check the configuration and software version:Enter 5188 matain menu, you can find the Monitor
Information key, tap it, you can get the monitor software information.
Chapter 4-1
Troubleshooting
Temp module
version
Before troubleshooting the patient monitor, check for technical alarm message. If a fault message is
presented, eliminate the fault first. For detailed information on the fault prompts, possible cause and
corrective action, refer to the patient monitor’s User Manual.
Chapter 4-2
Troubleshooting
Chapter 4-3
Troubleshooting
Chapter 4-4
Troubleshooting
management
Check out the cuff ,the cuff pipe ,or the
The type of the patient is wrong
interface socket
Check out the cuff ,the cuff pipe ,or the
Inflate air The accessories has an air leakage
interface socket
repeat(NO NIBP
Inflatable with numerical display, but the
values )
The NIBP pump has an air leakage value is not stable, it can be seen that the
numerical decline phenomenon
The NIBP module is defective Replace the NIBP module
Check out the type of the patient in the patient
The type of the patient is wrong
management
1. The cuff is tied up so tight or too loose
The NIBP values
The NIBP accessories have leakage 2. The cuff has leakage or is defective
is incorrect
3. The NIBP pipe has leakage
The NIBP module is defective Replace the NIBP module
The main board is defective Replace the main board
Chapter 4-5
Troubleshooting
The cable from the SPO2 module to Check the cable from SPO2 module to side plate
The SpO2 no side plate socket is not connect well socket and reconnect them
waveform
and value 1. Check that the cable between the Motherboard
Cables from Motherboard to SPO2
to the SPO2 module is correctly connected.
module are defective or poorly
2. Check that the cables and connectors are not
connected.
damaged
Chapter 4-6
Troubleshooting
Patient factor
SpO2 value 1 patient moved too much
is incorrect 2 NIBP same side
Start the SPO2 measurement in a normal state
3 Nail is with nail polish
4 Finger is with wound
Chapter 4-7
Troubleshooting
and no
Please enable the IBP module, For more details, you can
waveforms IBP module is disabled
refer to the user manual.
Cables from Motherboard to 1. Check that the cable between the Motherboard to the
IBP module are defective or IBP module is correctly connected.
poorly connected 2. Check that the cables and connectors are not damage.
The cable from the IBP module
Check the cable from IBP module to side plate socket
to side plate socket is not
and reconnect them
connect well
IBP module is defective Replace the IBP module
Motherboard is defective Replace the Motherboard
1. Zeroing must be done before use
2. Disposable IBP sensor must be change after single
The IBP settings are incorrect use
IBP readings 3. Ensure the channel you set is the channel you are
are incorrect using
The IBP extension cable or
Replace the extension cable or sensor
sensor is defected
The IBP module is defective Replace the IBP module
Cables from Motherboard to 1. Check that the cable between the Motherboard to
NO TEMP values ECG module are defective or the ECG module is correctly connected.
poorly connected 2. Check that the cables and probe are not damage
Chapter 4-8
Troubleshooting
The TEMP socket defective Check out whether it has a bad contact
The TEMP probe defective Change a TEMP probe
TEMP Value The ECG module is
Replace the ECG module
unstable defective
The Mother board is
Replace the Mother board
defective
Chapter 4-9
Troubleshooting
Chapter 4-10
Troubleshooting
Can’t communicate with CMS, Settings problem Reset the IP address and monitor
but connection is ok configuration according the user manual
Chapter 4-11
Troubleshooting
The system software is able to be upgraded with the USB disk through USB interface on monitor.
5.1 Tools
1. Before software upgrade, please check software version and record it to make sure you are able to
revert back in case the failure of software upgrade.
2. Take a USB-Stick, the size of the USB Stick should be 2GB/4GB(recommend), format it to “FAT” format
before software upgrade;
3. Unzip the package file that got from us and copy the folder * to the root directory in USB-Stick, do not
change the folder name or the file name(s) in the folder unless you are informed by usto have the
necessary change.
4. The folder name should be “SOFTUPDATE” in capital.
Chapter 5-12
Performance Verification
NOTE
u Make sure you have confirmed with COMEN Customer Service Department the software
package is fit for the software upgrade for the monitor you are currently operating on.
u Disconnect the patient monitor from patient before software upgrade;
u Make sure the battery capacity is enough or plug on AC power while doing the software
upgrade process, it takes around 2-10 minutes during the whole upgrade;
u Program upgrade should be performed by qualified service personnel only.
u Do not unplug the USB-Stick during the software upgrade process.
Chapter 5-2
Chapter 6 Performance Verification
Tools required:
l NIBP cuff for adult patient
l Appropriate tubing
l Cylinder
Follow this procedure to perform the test:
1. Set [Patient type] to [Adult].
2. Connect the NIBP cuff with the NIBP socket on the monitor.
3. Apply the cuff to the cylinder as shown below.
Chapter 6-1
Performance Verification
Tools required:
n T-shape connector
n Appropriate tubing
n Balloon pump
n Metal Vessel with volume 500 ± 25 ml
n Reference manometer (calibrated with accuracy equal to or greater than 1 mmHg)
Follow this procedure to perform a NIBP calibration:
1. Connect the equipment as shown below.
2. Before inflation, the reading of the manometer should be 0. If not, open the balloon pump to let the
whole airway open to the atmosphere. Close the balloon pump after the reading is 0.
3. Check the manometer values and the monitor values. Both should be 0mmHg.
4. Set [NIBP Pressure] to 150 mmHg in the [NIBP Measurement Circuit]. Raise the pump pressure to 150
mmHg. After the pressure value is stabilized, select the[Calibrate] button to start a calibration.
5. Set patient type to [Adult/Pediatric] in the [Overpressure Protection Circuit], and raise the pressure to
350 mmHg. After the pressure value is stabilized, select [Calibrate] to start a calibration.
6. Set the patient type to [Neonate] in the [Overpressure Protection Circuit], and raise the pressure to
165 mmHg. After the pressure value is stabilized, select [Calibrate] to start a calibration.
All calibration results are displayed in the [Calibrate NIBP] menu. If the calibration fails, check the test
system for leakage and perform another calibration.
1. Connect SpO2 sensor to the SpO2 connector of the monitor, and set patient type to [Adult] ;
Chapter 6-2
Performance Verification
3. Check the PLETH wave and PR reading on the screen and make sure that the displayedSpO2 is within
95%-100%.
4. Remove the SpO2 sensor from your finger and make sure that warning message of SpO2 SensorOff is
triggered.
Tool required:MX960(medex)
Follow this procedure to perform the test.
1. Connect the patient simulator to IBP1 socket..
2. Click the IBP baseline on the screen, select “CH press set up”, set “ART” as CH1(arterial
pressure).Enter “SURVEY set up” menu, select IBP(1,2)setup select “IBP PRESSURE ZERO”, select
“CH1 ZERO”. Follow up the next step after screen display “IBP CH1 zero success”.
3. Press MX960 keypad continuously.
4. The IBP value show 100±1mmHg
5. Repeat the steps above for all the IBP channels.
Tools required:
l A steel gas cylinder with 6±0.05% CO2 and balance gas N2
l T-shape connector
l Tubing
Follow this procedure to perform the test:
1. Plug the module into the module rack.
Chapter 6-3
Performance Verification
2. Wait until the CO2 module warmup is finished, and check the airway for leakage and perform a
leakage test as well to make sure the airway has no leakage.
3. In the [ CO2] menu—->CO2setupàselect [Zero].
4. Connect the test system as follows:
5. Open the relief valve to vent standard CO2 and make sure that there is an excess gas flow through
theT-shape connector to air.
6. Check the realtime CO2 value is within 6±0.05% in the [zero CO2] menu.
Tool required:
Fluke Medsim 300B, MPS450 or other patient simulator recommended
Follow this procedure to perform the test:
1. Connect the patient simulator with the ECG module using an ECG cable.
2. Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitudes 1mV.
3. Check the ECG waves are displayed correctly without noise and the displayed HR values within 80 ± 1
bpm.
4. Disconnect each of the leads in turn and observe the corresponding lead off message displayed on the
screen.
5. Set that the simulator outputs paced signals and set [PACE] to [ON] on the monitor’s patient manage
interface. Check the pace pulse marks on the monitor screen.
Tool required:
Vernier caliper
Follow this procedure to perform a calibration:
1. Select the 1st channel ECG waveform area→ [FILTER]→ [DIA].
2. Select [MAIN MENU]→ [MAINTAIN] →PASSWORD “5188” →[ECG Calibrate].
3. Select [ECG CAL]. A square wave appears on the screen and the message [CAL, can’t monitor] is
Chapter 6-4
Performance Verification
displayed.
4. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%.
5. After completing the calibration, select [STOP ECG CAL].
If necessary, you can print out the square wave and wave scale through the recorder and then measure the
difference.
Tool required:
Fluke Medsim 300B, MPS450 or other patient simulator recommended
Follow this procedure to perform the test:
1. Connect the patient simulator to the module using a non ESU-proof cable and set lead IIas the
respiration lead.
2. Configure the simulator as follows: lead II as the respiration lead, base impedance line as 1500 Ω; delta
impedance as 0.5 Ω, respiration rate as 40 rpm.
3. Check the RESP wave is displayed without any distortion and the displayed RESP value is within 40 ±
1 rpm.6.1 Spo2 Test
1. Connect SpO2 sensor to the SpO2 connector of the monitor. Set [Patient type.] to [Adu]on the monitor
and set [PR Source] to SpO2 on the monitor.
2. Measure SpO2 on your finger. (Assume that you stay healthy)
3. Check the PLETH wave and PR reading on the screen and make sure that the reading of SpO2 is within
95%-100%.
4. Remove the SpO2 sensor from your finger and make sure that an alarm of SpO2 Sensor Off is
triggered.
Tool required:
Resistance box (with accuracy above 0.1Ω)
Follow this procedure to perform the test:
a) Connect the two pins of any Temp connector of a module to the two ends of the resistance box using 2
wires.
b) Set the resistance box to 1354.9Ω (corresponding temperature is 37ºC).
c) Verify each Temp channel of the monitor and make sure that the displayed value is within 37 ±
0.1ºC.You can also use a patient simulator to perform the Temp test.
Chapter 6-5
Performance Verification
The following section describes the disassembly and reassembly procedures for the monitor and its
components
Only qualified service personnel (biomedical engineers or technicians) should open the monitor housing,
remove and replace components or make adjustments. If your medical facility does not have qualified
service personnel, contact COMEN or your local COMEN representative.
Chapter 7-6
Disassembling the Monitor
Caution
High-Voltage – Voltages dangerous to life are present in the instrument when it is connected to the
mains power supply. Do not perform any disassembly procedures (other than server removal) with
power applied to the instrument. Failure to adhere to this warning could cause serious injury or death.
Tools required
l Screwdrivers
l Small flat head screwdriver
l Needle Nose Pliers
l ESD mat and wrist strap
l Cleaning agent
l Tweezer
l Torx screwdrivers
l Needle Nose Pliers
l ESD mat and wrist strap
l Cleaning agent
l Tweezer
1. Open the battery compartment by removing the 4 screws on the back of monitor.
2. Disconnect the battery cable and then take out the battery as below shows.
Chapter 7-3
Disassembling the Monitor
Chapter 7-4
Disassembling the Monitor
Caution:
u Do not touch the LCD panel
u Disassemble the LCD in an environment as dust-free as possible
u Screen panel is fragile, be careful in installation or disassemble
4. Unscrew the 7 screws to separate the LCD carefully from the front panel of the monitor show as
above;
5. Unscrew the 4 screws on top and bottom of LCD frame to separate the LCD carefully from the LCD
frame, as show below;
Chapter 7-5
Disassembling the Monitor
Chapter 7-6
Disassembling the Monitor
Chapter 7-7
Disassembling the Monitor
3. Unscrew the 5 screws, you can take out the 7 parameter chassis and the side panel, unscrew the 2
screws, then you can separate the side panel and the 7 parameter chassis.
4. Unscrew the 2screwson speaker holder to remove the speaker.
Chapter 7-8
Disassembling the Monitor
Remove the 4 screws on ECG board, then remove the ECG board.
Chapter 7-9