Professional Documents
Culture Documents
Defibrillator/Monitor
Service Manual
and
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject
to change without prior notice.
Version number
7.0
Release time:
May 2011
2009-2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
Company Contact
Manufacturer:
E-mail Address:
service@mindray.com
Tel:
Fax:
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not
intended to be a comprehensive, in-depth explanation of the product architecture or technical
implementation. Observance of the manual is a prerequisite for proper equipment
maintenance and prevents equipment damage and personnel injury.
Intended Audience
This manual is for biomedical engineers, authorized technicians or service representatives
responsible for troubleshooting, repairing and maintaining the defibrillator/ monitors
Passwords
Passwords may be required to access different modes. The passwords are listed below:
Installation mode:
888888
Service mode:
332888
Configuration mode:
315666
II
Contents
1 Safety ................................................................................................................................. 1-1
1.1 Safety Information .......................................................................................................... 1-1
1.1.1 Dangers .............................................................................................................. 1-2
1.1.2 Warnings............................................................................................................. 1-2
1.1.3 Cautions ............................................................................................................. 1-2
1.1.4 Notes .................................................................................................................. 1-3
1.2 Equipment Symbols ........................................................................................................ 1-3
2 Theory of Operation ........................................................................................................ 2-1
2.1 The Basics ....................................................................................................................... 2-1
2.1.1 Overview ............................................................................................................ 2-1
2.1.2 Main Functions................................................................................................... 2-1
2.2 Components .................................................................................................................... 2-2
2.3 Main Unit ........................................................................................................................ 2-2
2.4 Front Housing Assembly................................................................................................. 2-4
2.5 Paddle Tray ..................................................................................................................... 2-6
2.6 Rear Housing Assembly.................................................................................................. 2-6
2.6.1 Power System..................................................................................................... 2-6
2.6.2 Main Control System ......................................................................................... 2-7
2.6.3 Therapy System.................................................................................................. 2-7
2.6.4 Parameter Measurement System ........................................................................ 2-7
2.7 External Device Connectors............................................................................................ 2-8
3 Unpacking and Installation ............................................................................................. 3-1
3.1 Unpacking the Equipment............................................................................................... 3-1
3.2 Preparation for Installation.............................................................................................. 3-2
3.2.1 Preparation for Installation Site.......................................................................... 3-2
3.2.2 Electrical Requirements ..................................................................................... 3-3
3.3 Vehicle Mount Kit Installation ........................................................................................ 3-3
3.4 Installing Hook Kit or Conductive Gel Container Kit..................................................... 3-3
3.5 Preparation for Power On................................................................................................ 3-3
3.6 User Test.......................................................................................................................... 3-4
4 Testing and Maintenance................................................................................................. 4-1
4.1 Introduction..................................................................................................................... 4-1
4.1.1 Test Report ......................................................................................................... 4-2
4.1.2 Preventative Maintenance .................................................................................. 4-2
4.1.3 Recommended Frequency .................................................................................. 4-3
4.2 Preventative Maintenance Procedures ............................................................................ 4-4
1
1 Safety
1.1 Safety Information
DANGER
z
Indicates an imminent hazard that, if not avoided, will result in death, serious
personal injury or property damage.
WARNING
z
CAUTION
z
NOTE
z
Provides application tips or other useful information to ensure that you can better
service your product.
1-1
1.1.1 Dangers
WARNING
z
Do not open the equipment cases to avoid shock hazard. All servicing and future
upgrades must be carried out by the personnel trained and authorized by our
company only.
1.1.2 Warnings
WARNING
z
When disposing of the packaging material, be sure to observe the applicable waste
control regulations and keep it out of childrens reach.
1.1.3 Cautions
CAUTION
z
Make sure that no electromagnetic radiation interferes with the performance of the
equipment when preparing to carry out performance tests. Mobile phone, X-ray
equipment or MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
Before connecting the equipment to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the
equipments label or in this manual.
Protect the equipment from damage caused by drop, impact, strong vibration or
other mechanical force during servicing.
1-2
1.1.4 Notes
NOTE
z
Equipotential terminal
Danger: High-voltage
Service indicator
Alternating current(AC)
Network connector
Battery
Video output
USB connector
Analog input/out
1-3
1-4
2 Theory of Operation
2.1 The Basics
2.1.1 Overview
BeneHeart D6 defibrillator/monitor (hereinafter called the equipment) provides four
operating modes: Manual Defib, AED, Pacer, and Monitor. The equipment is for use in
hospital and pre-hospital settings. It adopts the most advanced biphasic defibrillation
technology and can deliver up to 360J of defibrillation energy.
BeneHeart D6 has an 8.4" LCD display.
In Manual Defib Mode, the operator analyzes the patients ECG, and, if appropriate, follows
this procedure:
1
Select the Manual Defib mode, adjust the energy level if necessary
Charge; and
AED Mode
In AED mode, the equipment automatically analyzes the patients ECG rhythm and
indicates whether or not a shockable rhythm is detected. Voice prompts provide
easy-to-follow instructions and patient information to guide you through the
defibrillation process. Messages and flashing buttons are also presented to reinforce the
voice prompts.
Pacer Mode
The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are
delivered through multifunction electrode pads using a monophasic square waveform.
2-1
Monitor Mode
In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing,
storing and printing multiple physiological parameters and waveforms including ECG,
pulse oximetry (SpO2), temperature (Temp), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP) and carbon dioxide (CO2).
2.2 Components
The equipment consists of a main unit, accessories and PC software.
The main unit is the core of the equipment. It provides:
Display;
AED ;
Man-mahcine interface;
The front housing assembly mainly consists of LCD, keypad board, recorder, speaker,
microphone, Mode Select knob, navigation knob, backlight inverter, alarm lamp board,
indicating lamp board, front housing and front housing sheet metal, etc.
The rear housing assembly consists of CPU board, therapy module, high voltage
capacitors, MPM module, CO2 module, power management board, wireless network
adapter, fan, measurement module panel, therapy port, and rear housing, etc.
2-2
Input subsystem: Its input includes keypad board, microphone, Mode Select knob,
navigation knob, and paddle handle controls.
Output subsystem: includes display screen, alarm lamp board, recorder, and speaker
Processing and communication subsystem: includes CPU board, therapy module, MPM
module, and CO2 module.
System Structure
2-3
Navigation Knob
You can rotate the knob clockwise or counterclockwise and then press it to confirm a
selection. The knob is connected to the keypad board.
Recorder
The recorder receives data from the CPU board and then sends the data to a thermal head for
printing. The recorder front panel has a key for starting/ stopping the recorder and a green
indicator which is lit when working normally. The recorder is connected to the keypad board
which board provides connection for the TR6F recorder. The block diagram and functional
modules of the recorder are shown as below.
2-4
Module
Description
Power Interface
Recorder CPU
Receives control signals sent by the recorder CPU to drive the step
motor.
FPC Interface
Speaker
The speaker emits alarm tones, key-stroke tone, heart beats and PR sound. It supports the
functions of PITCH TONE and the multi-level volume. The speaker is connected to the
keypad board.
Microphone
It provides the function of voice recording.
AC/DC board: The AC mains is the input, and the outputs is 18VDC.
2-6
The main control module mainly consists of the CPU and FPGA. CPU is used to provide
least required internal storage, program memory, large capacity non-volatile storage, and the
watch dog. It connects EEPROM and other peripheral ICs such as Ethernet PHY chip. FPGA
performs the main functions of display and audio. Besides, it has the function of adapting
interfaces from CPU to MPM module, the keypad board and the recorder. CPU controls
FPGA via Flexbus.
The therapy module adopts DSP+MCU framework. MCU is responsible for therapy control
while DSP for ECG and impedance detection, AED algorithm, monitoring algorithm, pacing
algorithm, auxiliary therapy control, etc.
2-7
1
6
7
8
9
1.
Hook
2.
Battery 2
3.
Battery 1
4.
External power input: It connects an AC power cord or a DC/AC adapter to run the
equipment respectively on the external AC mains or DC power supply.
5.
Equipotential grounding terminal: When the defibrillator/monitor and other devices are
to be used together, their equipotential grounding terminals should be connected
together to eliminate the potential difference between them.
6.
USB connector: It connects the USB memory for data export. Data stored in the internal
CF card can be transferred to the USB memory and then export to a PC via the data
management software.
7.
8.
9.
2-8
All the optional parts purchased by the customer shall also be checked.
Notify the supplier if provided components are not correct as compared to the packing
list.
In case of damage during transportation, keep the packing material and notify the
supplier immediately.
Main unit
Accessory packing
Accessory packing
3-1
Ensure that the site meets all safety, environmental and power requirements
2.
3.
WARNING
z
Only power cables provided with the system may be used. For reasons of safety,
power (mains) extension cables or adapters shall not be used.
Environmental Requirements
WARNING
z
To avoid explosion hazard, do not use the equipment in the presence of flammable
anaesthetics, vapours or liquids.
CAUTION
z
Operating humidity
Operating altitude
Storage temperature
-30 to 70
Storage humidity
Storage altitude
3-2
The insulation of patient cables and leadwires is not damaged, and connectors are not
loose.
WARNING
z
3-wire power cord is used. The power socket should be 3-wire also. This ensures that the
defibrillator/monitor is properly grounded. Do not use 2-wire power cord or socket.
The defibrillator/monitor is not placed under the infusion bag or placed where their
might be liquid spillage. This protects the defibrillator/monitor from liquid ingress.
3-3
2.
Connect the external paddles. If pads are used, connect the test load.
3.
Select the Main Menu button on the equipments front panel and select [User Test >>].
Select all test items and press [Start] to perform user test.
NOTE
z
Install the battery and properly place the external paddles in the paddle tray or
connect the pads cable and 50 test load. Otherwise the User Test will fail.
Refer to BeneHeart D6 Operating Manual for the detailed information on user test.
3-4
CAUTION
z
Care should be taken to change the settings in [Installation Mode] and [Service
Mode] menus to avoid loss of data.
Before testing, service personnel should acquaint themselves with the test tools and
make sure that test tools and cables are applicable.
When testing monitoring parameters, move the Mode Select knob to Monitor to
access the Monitor Mode.
When performing therapy function tests, move the Mode Select knob to
corresponding mode.
4-1
Visual inspection
4-2
After
repair
Function
suspected
6
months
Visual inspection
Power-on Test
User test
Recorder check
Performance test
Module calibration
Resp
Performance test
SpO2
Performance test
Temp
Performance test
Leakage test
Module calibration
Manual
defibrillation
tests
12
months
24
months
Charge/
discharge
Energy disarming
Synchronous
defibrillation
Pacing test
ECG
Accuracy test
NIBP
Leakage test
Module calibration
IBP
CO2
Performance test
Pressure calibration
Electrical
safety tests as
per
IEC60601-1
Patient auxiliary
current
4-3
Carefully inspect the housing, the display screen and the buttons for physical damage.
Inspect all external connections for loose connectors, bent pins or frayed cables.
Inspect all connectors on the equipment for loose connectors or bent pins.
Make sure that safety labels and data plates on the equipment are clearly legible.
T-shape connector
Tubing
Balloon pump
Defibrillator/monitor
Connector for
NIBP cuff
Manometer
Tubing
Metal vessel
Balloon pump
2.
Before inflation, the reading of the manometer should be 0. If not, disconnect the airway
and reconnect it until the readings is 0.
3.
Press the Main menu button on the equipments front panel. Select
[Others>>][Installation Mode>>] enter the required password[Maintain
NIBP] [Start Accuracy Test].
4-4
4.
Compare the value of manometer with the value displayed on the equipments screen.
The difference should be no greater than 3 mmHg.
5.
Raise the pressure in the metal vessel to 50 mmHg with the balloon pump. Repeat steps
3 and 4.
6.
Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Repeat steps
3 and 4.
Note
z
You can replace the balloon pump and manometer with a blood pressure simulator
to form a test system.
An adult cuff
An air tubing
2.
Cylinder
Defibrillator/monitor
Connector for
Tubing
NIBP cuff
3.
Cuff
Press the Main menu button on the equipments front panel. Select [Others>>]
[Installation Mode>>] enter the required password[Maintain NIBP] [Start
Leakage Test].
After about 20 seconds, the equipment automatically deflates. This means the leakage test
finishes.
When the accuracy test is completed, the result will be displayed. If the message [NIBP
Pneumatic Leak] is displayed, it indicates that the NIBP airway may have leakages. Check
the tubing and connections for leakages, and then perform a leakage test again.
4-5
Calibrating NIBP
Tools required:
T-shape connector
Tubing
Balloon pump
1.
Defibrillator/monitor
Connector for
NIBP cuff
Manometer
Tubing
Balloon pump
Metal vessel
2.
Before inflation, the reading of the manometer should be 0. If not, disconnect the
airway and reconnect it until the readings is 0
3.
Press the Main menu button on the equipments front panel. Select [Others>>]
[Service Mode>>] enter the required password[Calibrate NIBP].
4.
Calibrate pressure. To do so, set the calibration value to 150 mmHg and adjust the pump
output pressure to 150 mmHg. After the system is stable, click the [Calibrate] button to
start calibration.
5.
set [Patient Cat.] to [Adu/Ped] and adjust pump output pressure to 330 mmHg.
Click the [Calibrate] button and start calibration. Or
set [Patient Cat.] to [Neo] and adjust pump output pressure to 165 mmHg. Click
the [Calibrate] button and start calibration.
All the calibration results will be displayed in the [Calibrating NIBP] screen. If the
calibration fails, please check the connections and then perform a calibration again.
4-6
Access the [CO2 Setup] menu and set [Operating Mode] to [Measure].Wait for CO2
warm-up.
2.
Block the CO2 module gas inlet completely. This will cause different reactions from the
Sidestream and Microstream CO2 modules.
Sidestream: Check that alarm message [CO2 Filter Line Err] is displayed on the
screen in 3s. Block the gas inlet for another 30s, if the alarm message does not
disappear, the module does not leak.
Microstream CO2 module: [CO2 Purging] is displayed in 3s. Block the gas inlet
for another 30s, if the alarm message [CO2 Tubing Err] appears, the module does
not leak.
Module Calibration
Test tools
T-shape connector
Tubing
For sidestream CO2 module, zeroing is required before calibration. Enter [CO2 Setup] menu
and select [Zero] to perform zeroing.
To calibrate the CO2 module, follow this procedure:
1.
Make sure that the CO2 module has been warmed up or started up.
2.
Connect the gas cylinder with the tubing using a T-shape connector as shown below.
Check the airway and make sure there are no leaks.
To the air
Gas valve
Tubing
Defibrillator
/monitor
Gas cylinder
4-7
3.
4.
Access the [Maintain CO2] menu. To do so, Press the Main Menu button on the
equipments front panel. Select [Others>>][Installation Mode>>] enter the
required password [Maintain CO2].
5.
In the [Maintain CO2] menu, select a CO2 value equal to the vented CO2
concentration.
6.
In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. Wait till
the measured CO2 concentration becomes stable; select [Calibrate] to start CO2
calibrate.
Model/No.
4-8
Test items
Test records
Test results
(Pass/Failed)
Visual inspection
The case, display screen, buttons, knob, SMR, modules, power
cord, wall-mount bracket and accessories have no obvious signs
of damage.
The external connecting cables are not frayed and the connector
pins are not loose and bent.
The external connectors are not loose or their pins are not bent.
The safety labels and data plate are clearly legible.
NIBP test
The difference is within 3 mm when 0, 50 or 200 mmHg is set
for NIBP accuracy test.
There is no leakage with NIBP, or the manual leakage test result
does not exceed 6mmHg/min.
Sidestream CO2 test
Block the gas inlet of the module or watertrap. The sidestream
CO2 flowrate is slower than 10ml/min and an alarm of CO2
Filterline Err is given. It indicates that there is no leakage.
The displayed CO2 value is within 60.05.
Microstream CO2 test
Block the gas inlet of the module or watertrap. An alarm of CO2
Filterline Err is given. It indicates that there is no leakage.
The displayed CO2 value is within 60.05.
Place the external paddles on paddle tray, insert the battery (install both if two batteries
are configured) in the battery compartment, and then connect the equipment with AC
mains. In this case, both the AC indicator and battery indicator shall light.
2.
Turn the Mode Select knob to Monitor. Check that the equipment passes the self test and
is turned on properly.
3.
Check the display of technical alarm area, prompt area and battery status indicator on
the upper right corner of the main screen to judge whether the equipment runs normally.
4-9
If you use external paddles, place them on the paddle tray; if you use a pads cable,
connect it to the 50 test load.
2.
Insert the battery (2 if configured) into the equipment. Connect the AC mains if no
battery is available.
3.
Select the Main Menu button on the equipments front panel. In the Main Menu, select
[User Test>>]. Then a prompt Enter user test? pops up. Select Yes to enter the User
Test screen.
4.
Check the test items you want to perform and select [Start] to start user test
The test results indicate the condition of the system. If any item fails, the service indicator
flashes.
If you cannot pass User Test or the message Connect paddles cable, and place paddles in
paddle tray is shown when paddle cable is connected and paddles are placed in paddle tray,
check paddles status.
Select the Monitor mode. Press and hold the [Event] hardkey, and then press the [Lead
Select] hardkey on the front panel, the following screen appears.
0 x 182: The travel switch indicating paddle status may fail, but impedance is correct.
0 x 102 :Paddles are not properly placed in paddle tray and the impedance value is not
correct.
4-10
Defibrillator/pacer analyzer
Charge/Discharge
1.
Remove the batteries and connect the equipment with AC mains. Turn the Mode Select
knob to Manual Defib.
2.
Connect the external paddles to the equipment and place the paddles on the
defibrillator/pacer analyzer.
3.
Enter the Configuration-Main screen. From the Record Setup menu set [Shock Event]
to [On] so that shock events can be recorded automatically if happened.
4.
Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
5.
6.
0 to 3
100
85 to 115
360
306 to 414
Disconnect the equipment from the AC mains. Run the equipment on fully charged
battery. Move the Mode Select knob to Manual Defib. Repeat Steps 5 to 7.
9.
10. Verify that the equipment records the shock events automatically and correctly.
4-11
Energy Disarming
1.
Run the equipment on fully charged battery. Move the Mode Select knob to Manual
Defib.
2.
Connect the external paddles to the equipment and place the paddles on the
defibrillator/pacer analyzer.
3.
Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
4.
5.
6.
7.
8.
Verify that a prompt Charge Removed appears and the charge done tone stops.
9.
10. Enter the Configuration-Main menu, select [Manual Therapy Setup] and set [Time to
Auto Disarm] to [60s].
11. Exit Configuration Management. The equipment restarts automatically.
12. Set the analyzer to Energy Measurement mode. In this case, the energy value should be
displayed as 0 or blank.
13. Select the energy level to 360J.
14. Charge the equipment. Count time after charging is completed.. Verify that the prompt
Shock Removed appears on the equipment and the energy measured by the analyzer is
0J or blank after 60 seconds.
15. Use multifunctional electrode pads. Repeat Step 3 to Step 14.
Synchronous Defibrillation
1.
Connect the external paddles and ECG cable to the equipment. Place the paddles ECG
electrodes on the defibrillator/pacer analyzer.
2.
Set the analyzer to Measurement Mode and output normal sinus rhythms, e.g. amplitude
value 1mV and HR 60bpm.
3.
Enter Configuration Management. In the [Manual Therapy Setup] menu, set [Sync
After Shock] to [On].
4.
5.
Press the [Sync On] soft key to start synchronous defibrillation. If Remote Sync is
switched on, press the [Sync On] soft key and select [Local] to start synchronous
defibrillation
6.
7.
When charging finishes, press and hold the Shock button to deliver a shock.
8.
Verify that synchronous discharge succeeds and the delivery energy measured by the
analyzer is 10J2J.
9.
Verify that the delay time of synchronous defibrillation measured by the analyzer is less
than 60ms.
10. Verify that the synchronous discharge mark appears on the R wave.
11. Verify that the prompt messages are correct during testing.
12. Select lead II as ECG source and perform charging. Repeat steps 7 to 11.
13. Use multifunctional electrode pads. Repeat steps 2 to 12.
Defibrillator/pacer analyzer
1.
Run the equipment on fully charged battery. Move the Mode Select knob to Pacer. Set
[Pacer Mode] to [Fixed].
2.
Connect the pads cable to the equipment and properly place the pads on the
defibrillator/pacer analyzer.
3.
Set the analyzer to Pacing Measurement mode. Use test load of 50.
4.
On the equipment, set [Pacer rate] to [70ppm] and [Pacer Output] to [30mA].
5.
Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is
70 ppm1ppm and the pacer output measured is 30 mA5mA.
6.
Press the Stop Pacing soft key, and then set [Pacer rate] to [170ppm] and [Pacer
Output] to [200mA].
7.
Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is
170 ppm2ppm, and the measured current is 200 mA10mA.
4-13
ECG simulator
1.
2.
3.
ECG Calibration
1.
Select the ECG parameter area to enter the [ECG Setup] menu.
2.
3.
Compare the amplitude of the waveform with the wave scale. The difference should be
within 5%. If needed, you can also print out the waveform and the wave scale.
4.
4-14
1.
2.
On the defibrillator/monitor, select the Resp widow to enter the Resp Setup menu. Set
[Lead] to [II].
3.
Configure the simulator as follows: set Lead to II, base impedance line to 1500 ; delta
impedance to 0.5 , and respiration rate to 40 rpm.
4.
Check that respiration waveform is not distorted and the displayed Resp value does not
exceed 402 rpm.
Patient simulator
1.
2.
3.
Zero the transducer. To do so, vent the transducer to atmospheric pressure by turning on
the stopcock to the air. Select an IBP parameter window, e.g. Art, to enter [Art Setup]
menu. Select [Art Zero>>][Zero] to start a zero calibration. After the completion of
zero calibration, close the stopcock to the air and open the stopcock to the patient.
4.
5.
6.
4-15
Pressure Calibration
Tools required:
Standard sphygmomanometer
Balloon pump
Tubing
T-shape connector
To perform a calibration:
1.
Connect the 3-way stopcock, the sphygmomanometer and the balloon pump through a
T-shape connector, as shown below.
2.
3.
Press the Main menu button on the equipments front panel. Select [Others>>]
[Installation Mode>>] enter the required password[Maintain IBP]. Then
configure IBP calibration value.
4.
Inflate using the balloon pump until the reading of sphygmomanometer approximates
the preset calibration value.
Pressure transducer
3-way stopcock
T-shape connector
Sphygmomanometer
5.
Adjust the calibration value in the [Maintain IBP] menu until it is equal to the reading
of sphygmomanometer
6.
7.
4-16
Patient simulator.
1.
2.
Select the model and manufacturer of the SpO2 module under test. Configure the
parameter as SpO2 96% and PR 80 bmp.
3.
The displayed SpO2 and PR values should be within the ranges listed below
SpO2 (%)
PR (bmp)
Mindray
96% 2%
803
Masimo
96% 2%
803
Nellcor
96% 2%
96% 2.5%
96% 3%
96% 3.5%
803
Resistance box
1.
Connect the two pins of any Temp connector on equipment to the two ends of the
resistance box using 2 wires.
2.
Set the resistance box to 1354.9 (corresponding temperature is 37). The displayed
value on the equipment should not exceed 370.2.
4-17
Oscillograph
1.
Connect the patient simulator to the equipment under test using an ECG or IBP cable.
2.
3.
Verify that the waveforms displayed on the oscillograph is identical with those
displayed on the defibrillator/ monitor.
None.
1.
Print ECG waveforms. The recorder should print correctly and the printout should be
clear.
2.
Simulate some recorder problems, such as out of paper, paper jam, etc. the defibrillator/
monitor should give corresponding prompt messages. After the problem is removed, the
recorder should be able to work correctly.
3.
Switch automatic alarm recording for each parameter ON and then set each parameters
limit outside set alarm limits. Corresponding alarm recordings should be triggered when
parameter alarms occur.
4-18
2.
3.
Start the equipment and select the Monitor mode. Press and hold the [Event] hardkey,
and then press the [Lead Select] hardkey on the front panel, the following screen
appears.
4-19
4.
NOTE
z
If 300 ohms test load is not available, you can use a 50 ohms test load to perform
impedance checking. In this case, Verify that the reading of RT Imped is
between 50075.
Press the Main menu button on the equipments front panel. Select [Others>>]
[Service Mode>>] enter the required passwords[Calibrate/Zero Impedance] to
enter the Calibrate/Zero Impedance screen.
2.
Connect a test load of 0 ohm to the pads cable; then select Zero. A message Zero
Completed shall be shown. If the message Zero Failed is displayed, check the
connection of pads cable.
3.
Connect a test load of 100 ohms to the pads cable; then select Calibrate. A message
Calibration Completed shall be shown. If the message Calibration Failed is
displayed, check the connection of pads cable.
4-20
In the Device Information screen, you can select [Export] to export error codes and shock
delivery data to a USB flash memory.
Refer to 6.8 Error Codes for the description of each error code.
4-21
4-22
Test Report
Customer name
Customer address
Servicing person
Servicing company
Equipment under test
(EUT)
Model of EUT
SN of EUT
Hardware version
Software version
Test equipment
Model/No.
4-23
Test items
Test records
Visual inspection
The case, display screen, buttons, knob, modules, power cord, and
accessories have no obvious signs of damage.
The external connecting cables are not frayed and the connector pins
are not loose and bent.
The external connectors are not loose or their pins are not bent.
The safety labels and data plate are clearly legible.
Power-on test
The power-on test is passed. The power indicator and alarm system
work correctly and the equipment start up properly.
Performance test
Manual Defibrillation Test
When running on AC mains and external paddles are used, the
equipment can be properly charged and discharged; the energy
delivered meets accuracy requirement, and shock information is
correctly recorded.
When running on fully charged battery and external paddles are used,
the equipment can be properly charged and discharged; the energy
delivered meets accuracy requirement, and shock information is
correctly recorded.
When running on AC mains and multifuncational electrode pads are
used, the equipment can be properly charged and discharged; the
energy delivered meets accuracy requirement, and shock information
is correctly recorded.
When running on fully charged battery and multifuncational
electrode pads are used, the equipment can be properly charged and
discharged; the energy delivered meets accuracy requirement, and
shock information is correctly recorded.
When external paddles are used, charge tone is correctly issued when
the equipment is being charged. The prompt "Charged Removed" is
shown on the screen and charge done tone stops when the Disarm
hotkey is pressed. The equipment does not discharge externally.
When [Time to Auto Disarm] is set to [60s], the prompt "Charged
Removed" is shown on the screen and the charge done tone stops
after 60 seconds at the completion of charging. The equipment does
not discharge externally.
When pads are used, the charge tone is correctly issued when the
equipment is being charged. The prompt "Charged Removed" is
4-24
Test results
(Pass/Failed)
Test items
Test records
shown on the screen and the charge done tone stops when the Disarm
hotkey is pressed. The equipment does not discharge externally.
When [Time to Auto Disarm] is set to [60s], the prompt "Charged
Removed" is shown on the screen and the charge done tone stops
after 60 seconds at the completion of charging. The equipment does
not discharge externally.
When external paddles are used for synchronous defibrillation and
ECG source is paddles and lead II respectively, the prompt is correct
and a Sync mark appears above each R wave. The delivered energy
measured is 10J2J and the synchronous shock is delivered within 60
ms of the peak of the R-wave.
When pads are used for synchronous defibrillation and ECG source
is paddles and lead II respectively, the prompt is correct and a Sync
mark appears above each R wave. The delivered energy measured is
10J2J and the synchronous shock is delivered within 60 ms of the
peak of the R-wave.
Pacing Test
When set [Pacer rate] to [70ppm] and [Pacer Output] to [30mA],
the pacer rate measured by the analyzer is 70 ppm1ppm and the
pacer output measured is 30 mA5mA.
When set [Pacer rate] to [170ppm] and [Pacer Output] to
[200mA], the pacer rate measured by the analyzer is 170 ppm2ppm,
and the measured current is 200 mA10mA.
ECG performance test
ECG waves are displayed correctly without noise and the HR value
is within 801 bpm.
ECG Lead Off alarm behaves correctly.
Paced signals are detected and pace pulse marks are displayed when
[Paced] is set to [Yes]
The difference between the amplitude of the ECG calibration square
wave and that of the wave scale is not greater than 5%.
Resp test
Resp wave is not distorted and the Resp value is within 402 rpm.
NIBP test
The difference is within 3 mm when 0, 50 or 200 mmHg is set for
NIBP accuracy test.
There is no leakage with NIBP, or the manual leakage test result does
4-25
Test results
(Pass/Failed)
Test items
Test records
Test results
(Pass/Failed)
Date: ________________________
4-26
801-0651-00117-00
12-lead ECG
801-0651-00118-00
801-0651-00049-00
3/5-lead ECG/NIBP
801-0651-00050-00
801-0651-00051-00
801-0651-00052-00
801-0651-00053-00
Mindray SpO2/NIBP/IBP/TEMP
upgrade package
NellcorSpO2/NIBP/TEMP upgrade
package
NellcorSpO2/NIBP/IBP/TEM upgrade
package
801-0651-00056-00
801-0651-00059-00
801-0651-00060-00
801-0651-00061-00
801-0651-00062-00
5-1
/NIBP/TEMP
/NIBP/IBP/TEMP
/NIBP/TEMP
/NIBP/TEMP
/NIBP/IBP/TEMP
/NIBP/IBP/TEMP
801-0651-00053-00
801-0651-00061-00
3/5-lead ECG/Masimo
SpO2/NIBP/IBP/TEMP
801-0651-00060-00
NellcorSpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Nellcor
SpO2/NIBP/TEMP
801-0651-00062-00
NellcorSpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
801-0651-00116-00
12-lead ECG
801-0651-00056-00
801-0651-00059-00
/NIBP/TEMP
/NIBP/IBP/TEMP
/NIBP/TEMP
801-0651-00118-00
12-lead ECG
801-0651-00053-00
3/5-lead ECG/Mindray
SpO2/NIBP/TEMP
801-0651-00056-00
3/5-lead ECG/Mindray
SpO2/NIBP/IBP/TEMP
5-2
801-0651-00116-00
12-lead ECG
801-0651-00059-00
3/5-lead ECG/Masimo
SpO2/NIBP/TEMP
801-0651-00061-00
3/5-lead ECG/Masimo
SpO2/NIBP/IBP/TEMP
801-0651-00116-00
12-lead ECG
801-0651-00060-00
NellcorSpO2/NIBP/TEMP
upgrade package
3/5-lead ECG/Nellcor
SpO2/NIBP/TEMP
801-0651-00062-00
NellcorSpO2/NIBP/IBP/TEMP
upgrade package
3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
801-0651-00116-00
12-lead ECG
801-0651-00081-00
3/5-lead ECG/Mindray
SpO2/NIBP/IBP/TEMP
5-3
801-0651-00116-00
12-lead ECG
801-0651-00081-00
3/5-lead ECG/Mindray
SpO2/NIBP/IBP/TEMP
Description of upgrade
package
801-0651-00116-00
12-lead ECG
801-0651-00081-00
3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
Configuration after
upgrade
801-0651-00116-00
12-lead ECG
5-4
801-0651-00116-00
12-lead ECG
801-0651-00116-00
12-lead ECG
Remove the MPM module assembly and parameter panel assembly as described in 7.3.8
Disassembling the MPM Module.
2.
Replace the old parameter panel assembly and MPM module assembly with those in the
upgrade package.
3.
Remove the watertrap receptacle unit, or microstream CO2 connector assembly, or CO2
panel as described in 7.8 Disassembling the Measurement Module Panel Assembly.
4.
NOTE
z
If you need to upgrade 3/5-lead ECG to 12-lead ECG, insert the 12-lead ECG
board into the MPM module. Make sure that the 12-lead ECG board should be in
correct direction. Then fix the clip in place.
5-5
Clip 1
Clip 2
6. Stick correct parameter panel overlay on the parameter panel according to the
configuration you upgrade.
If the upgrade MPM module is equipped with Masimo SpO2, you need to stick a
Masimo label on the lower left corner of the front housing and a No Implied
License label below the parameter panel, as indicated in the following pictures.
Masimo label
If the upgraded MPM module is equipped with Nellcor SpO2, you need to stick a
Nellcor label at the lower left corner of the front housing, as indicated in the
following pictures.
Nellcor label
7.
5-6
2.
Take off the Mode Select knob. Peel off the Mode label.
3.
Replace the old therapy module with the one configured with pacing function in the
upgrade package.
4.
Replace the old Mode Select knob and Mode label with those in the upgrade package.
5.
Mode label
6.
After upgrade the therapy module, perform the tests described in 4.6 Module
Performance Tests.
5-7
801-0651-00079-00
801-0651-00082-00
801-0651-00080-00
Remove the parameter module panel assembly as described in 7.3.4 Removing the
Measurement Module Panel.
2.
Remove the left capacitor sheet metal as described in 7.3.9 Removing the CO2 Module.
3.
Install the required M02B CO2 module or microstream CO2 module on the left
capacitor sheet metal.
4.
Apply the CO2 insulating sheet on the MPM module mounting plate. Be careful to align
the edge of insulating plate with the edge of the metal plate when stick the insulating
plate to the metal sheet. Do not stick the screw holes on the metal sheet. Then bent the
insulating plate properly to avoid being cut by the insulating plate during later assembly
process.
5-8
CO2
insulating plate
Align the edge of
insulating plate with the
edge of the metal plate
Bent here
5.
Peel off the overlay on the parameter module panel and install the connector fixing part
of the microstream CO2 module or the watertrap receptacle kit and the gas outlet of the
Mindray CO2 module on the parameter module panel. Choose an appropriate overlay
from the upgrade package and apply it on the parameter module panel.
Gas outlet
Mindray CO2
watertrap kit
Microstream CO2
connector fixing part
6.
Install the left capacitor metal sheet with CO2 module in the machine.
7.
Reassemble the machine. Route the gas pipes to avoid blocking them.
8.
5-9
2.
Respectively plug the TR8A connecting cable into the recorder modules J1 and J3
sockets. Use two M36 Philips screws to secure the recorder.
Recorder
connecting cable
3.
TR8A recorder
Bootstrap
System software
Language library
FPGA program
2.
3.
Click [Ok] and the following screen appears. Click [Next] to go to the next step.
4.
5.
Specify the destination folder for installing this program. Then select [Next].
5-11
6.
7.
5-12
2.
3.
Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to
BneneHeart.
4.
On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select Package]
and select packages you want to upgrade. Then select [Start].
5.
Simultaneously hold the [Summary] key and [Menu] key on the defibrillator/monitors
front panel, and then turn on the equipment.
After software upgrade is finished, turn off the equipment, and then disconnect AC mains and
remove the battery. If you do not disconnect the power supply after software upgrade, the
status indicator will flash and the beeper will sound.
For the details of software upgrade, refer to help and instructions for use of Mindray Patient
Monitor Software Upgrade Tool.
CAUTION
z
Disconnect the equipment from the patient and make sure the important data are
saved before upgrade.
Do not shut down or power off the equipment when upgrading the boot program.
Otherwise, it may cause the equipment to break down.
NOTE
z
After upgrading the boot program, re-upgrade the system program and other
programs to ensure compatibility.
Make sure the version of the upgrade package is the one that you desired. If you
want to obtain the latest upgrade package, contact Mindray Customer Service
Department.
5-13
5.3.1 Precautions
1.
2.
If you are going to upgrade the software through a PC, do not plug a USB memory to
the defibrillator/monitors USB connector.
3.
Up to 15 upgrade files can be placed to the UPGRADE_0651 folder. If more files are
placed, only the first 15 can be displayed and chosen.
4.
Only one upgrade file can be chosen at a time. Repeat steps 3 to 5 as described in 5.3.2
Software Upgrade Procedure to upgrade files one by one.
5.
6.
Both .pkg and .mpkg files can be upgraded. Bootstrap cannot be included in the .mpkg
files.
7.
The bootstrap of main control should be upgrade separately. That is to say, it cannot be
included in the upgrade package.
Create a folder named UPGRADE_0651 in the root directory of the USB memory.
2.
3.
Turn off the defibrillator/monitor. Plug the USB memory to the equipments USB
connector.
4.
Simultaneously hold the [Summary] key and [Menu] key on the defibrillator/monitors
front panel, and then turn on the equipment.
5.
Follow the on-screen instructions to upgrade the software. Choose a file to be upgraded
by rotating the navigation knob. Press down the navigation knob to confirm the selection.
You have to choose the upgrade file within 120 s. If not, software upgrade fails. The
system will upgrade automatically when the upgrade file is selected and confirmed.
5-14
6 Troubleshooting
6.1 Overview
In this chapter, the defibrillator/monitor problems are listed along with possible causes and
recommended corrective actions. Refer to the tables to check the defibrillator/monitor,
identify and eliminate the problems.
The problems 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 Customer Service Department.
Select [Main Menu] [Review >>][Event Review >>]. Then you can view the
information on system start time, self check, etc.
2.
You can also view the information on the defibrillator/monitors current status by
pressing the Menu key on the equipments front panel, and then selecting
[Others>>][Service Mode>>] enter the required password [Device
Information>>].
6-1
6-2
The equipment
does not charge
by pressing the
Charge button on
the front panel.
The equipment
cannot be charged
by pressing the
Charge button on
the external
paddles.
Charging failed
Possible Cause
Corrective Action
Paddles failure.
The equipment is
charged too
slowly
A shock cannot be
delivered by
pressing the
Shock button on
the equipments
front panel in
Manual Defib
Mode or AED
Mode.
Battery failure.
6-3
Symptom
Possible Cause
Corrective Action
Paddles failure.
The message.
Disarming
Failed is
displayed.
The equipment
can be charged,
but the energy is
disarmed
automatically at
the completion of
charging or when
the equipment is
being discharged.
Paddles failure.
A shock cannot be
delivered by
pressing the
Shock button on
the paddles.
Defibrillation
malfunction.
Energy Select
buttons on the
equipment front
panel do not work.
Energy Select
buttons on the
paddles do not
work
The message
Defibrillation
malfunction
presented at
power-on
6-4
Possible Cause
Corrective Action
Pacer Equip
Malfunction
Possible Cause
Corrective Action
The
defibrillator/monitor
fails to start. AC
LED or battery LED
does not light
6-5
Possible Cause
Corrective Action
Connection cable
defective or poorly
connected.
Secondary display
does not function.
Backlight inverter
defective
Cable failure
Secondary display
displays snows or
flashing specks
Connection cable
defective or poorly
connected.
Images overlapped or
distorted
FPGA failure
Connection cable
defective or poorly
connected.
Symptom
Possible Cause
Corrective Action
Connection cable
defective or poorly
connected.
Display failure
Possible Cause
Corrective Action
The alarm
lamp is not
light or
extinguished
but alarm
sound is issued
No alarm
sound is issued
but alarm lamp
is lit
Speaker failure
6-7
Possible Cause
Corrective Action
Buttons do not
respond.
Connection cable
defective or poorly
connected.
Keypad board
failure
Power management
board failure.
Connection cable
defective or poorly
connected.
Navigation knob
does not respond.
Knob failure
Keypad board
failure
Power management
board failure.
Connection cable
defective or poorly
connected.
Knob failure.
Keypad board
failure
Power management
board failure.
6-8
Possible Cause
Corrective Action
No printout
Connection cable
defective or poorly
connected.
Recorder power
supply failure
Recorder failure
Blank printout
Recorder failure
Replace recorder
Paper-roll installed
reversely.
Reload paper-roll
Recorder failure
Possible Cause
Corrective Action
Power management
board failure.
Power management
board failure.
6-9
Possible Cause
Corrective Action
CF card malfunctions
Wrong CF card or
limited memory space
CF card defective
CF card failure
Possible Cause
Corrective Action
Faxing failure
Antenna is loose.
Wireless transmission
module failure
Y cable failure
6-10
Possible Cause
Corrective Action
Battery failure
Battery damaged.
Battery interface failure.
Replace battery.
1. Check batteries are installed properly.
2. Check if the battery interface is defective.
3. If the battery interface is defective,
replace the power management board.
Replace the power management board.
Battery cannot be
charged
Power management
board failure.
Battery damaged.
Battery interface failure.
Power management
board failure.
Battery failure.
Cable defective or
poorly connected
Power management
board failure.
No +3.3 V A output
No +3.3 V B output
Not +5.0 V output
Replace batteries.
1. Check batteries are installed properly.
2. Check if the battery interface is defective.
3. If the battery interface is defective, replace
the power management board.
Replace the power management board.
No +12 V output
NOTE
z
When the power module has a failure, it may cause problems to other components,
e.g. the defibrillator/monitor suddenly breaks down during start-up, as the power
module may have a power supply protection. In this case, troubleshoot the power
module per the procedure described in the table above.
Components of the main unit, SMR and parameter modules are powered by the
power module. In the event that a component malfunctions, check if the operating
voltage is correct. Refer to Chapter2 Theory of Operation for the operating voltage
and measurement points of each component.
6-11
Possible Cause
Corrective Action
Power failure or
unintended power off
during boot file upgrade
Incorrect network
connection
Incorrect IP address
configuration
6-12
Error description
No error
10
11
12
13
14
15 to 20
Reserved
21
22
23
24
25
26 to 30
Reserved
31
32
33
Over-charging
34
35 to 40
Reserved
41
Self-discharging failure
42
IGBT failure
43
Error codes
Error description
44
45 to 70
Reserved
71
72
73
74
75
Pacer DA error
76
77
78
79 to 90
Reserved
91
92 to 99
Reserved
Error contents
100/register value
101/register value
102
103
104
105
106
107 to 199
Reserved
6-14
Error contents
200
201
202
203
204
205/register value
206
207
208
209
210
211 to 299
Reserved
Error contents
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
Error codes
Error contents
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331 to 399
6-16
Phillips screwdrivers
Tweezers
7# Socket wrench
Adjustable spanner
7-1
Stop patient monitoring and therapy, turn off the equipment and disconnect all the
accessories and peripheral devices.
To avoid high voltage hazard, strictly follow the procedure as defined in section 7.3.6
Discharging the Capacitor for disassembling.
WARNING
z
Before disassembling the equipment, be sure to eliminate the static charges first.
When disassembling the parts labeled with static-sensitive symbols, make sure you
are wearing electrostatic discharge protection such as antistatic wristband or
gloves to avoid damaging the equipment.
Properly connect and route the cables and wires when reassembling the equipment
to avoid short circuit.
Select appropriate screws to assemble the equipment. If unfit screws are tightened
by force, the equipment may be damaged and the screws or part may fall off
during use, causing unpredictable equipment damage or human injury.
Disconnect all the cables before disassembling any parts. Be careful not to damage
any cables or connectors.
Place removed screws and disassembled parts properly, preventing them from
being lost or contaminated.
Place the screws and parts from the same module together to facilitate
reassembling.
To reassemble the equipment, first assemble the assemblies, and then the main
unit. Carefully route the cables.
Make sure that the waterproof material is properly applied during reassembling.
7-2
To disassemble the equipment, first remove the external assemblies, such as the
hook mount, wireless transmission module,paddle tray and front housing, and then
the internal assemblies and parts.
The power supply assembly and recorder can be removed without removing any
other assemblies.
To disassemble the equipment, place the equipment on a work surface free from
foreign material, avoiding damaging the antiglare screen, LCD and the knob. Be
careful not to break the two cotters on the front ends of rear housing.
All the operations should be performed by qualified service personnel only. Make
sure to put on the insulating gloves during service operations.
Before remove the therapy module high-voltage board, you must use the dicharge
fixture to discharge the capacitor first. If you do not have a discharge fixture,
disconnect AC mains and remove batteries, Wait for at least 2 hours before
removing the capacitor.
Stand the equipment on the work surface with the back of the equipment facing to you.
Loose and remove the two M316 Philips screws; take off the flat washer and spring
washer. Pull out the hooks.
7-3
Stand the equipment on the work surface with the back of the equipment facing to you.
Tweeze the five plastic plugs in the screw holes.
2.
Loose and remove the five M310 Philips screws. Remove the paddle tray.
3. Make sure that the waterproof strip is properly applied when replacing the paddle tray in
the equipment.
Waterproof strip on
the top of rear case
7-4
Lay the equipment on a padded work surface with the display facing down and the
bottom of the equipment nearest to you. Be careful not to damage the LCD and controls.
Loose and remove the 7 M310 Philips screws.
2.
Stand the equipment on the work surface. Carefully separate the front housing and the
rear housing. Disconnect the cable between the CPU board and keypad board, and then
remove the front housing.
3.
Make sure that the waterproof strip is properly applied when reassemble the front
housing.
Cotter
Disconnect this cable
Waterproof strip (in the slot)
7-5
Stand the equipment on the work surface. Loose and remove the M36 Philips screw
that secures the flexible cable. You can also disconnect the flexible cable by loosening
the plastic nut behind the SpO2 board. Remove the flexible cable.
2.
Fastening
frame
Flexible cable
M36 Philips
screws
3.
If you equipment is configured with a NIBP module, disconnect the NIBP air tube. If
you equipment is configured with a CO2 module, disconnect the cables between the
CO2 module and the module connector.
If Mindray CO2 module is configured, disconnect the Nafion tube, CO2 exhaust
tube, micro-active switch connector and flow limit tube.
If the microstream CO2 module is configured, disconnect the CO2 exhaust tube
and remove the CO2 connector assembly. If the connector assembly is difficult to
be removed, disconnect the air tube and cable on it. Take care not to damage the air
tube and cables. Remove the measurement module panel.
Nafion tube
NIBP air tub
CO2 exhaust tube
Flow limit tube
Micro-active switch connector
7-6
Microstream
CO2 connector
NOTE
z
Be careful not to damage the air tube when disconnecting the air tube or the cable
between the CO2 module and the module connector. During reassembly, route the
air tube and cable so that they are placed between the MPM module and CO2
module, making sure not to block the air tube.
When replacing the measurement module panel, do not screw the flexible cable
forcibly avoiding screw slipping. In case the screw slips, fasten the plastic bolt with
the nut before screwing.
When the equipment is reassembled, make sure that the frame securing the
measurement module panel does not bend the two cotters on the rear housing.
7-7
Lay the equipment on a padded work surface with the display side facing down and the
bottom of the equipment nearest to you. Be careful not to break the two cotters in the
front of rear housing. Loose and remove the two M38 Philips screws and pull out the
power supply assembly.
2.
Disconnect the cable between the power management board and AC/DC module.
Remove the Power Supply Assembly.
Cable between the power management
board and AC/DC module
7-8
Before removing the capacitor, you must wear insulation gloves which stand high
voltage.
1.
Use the high-voltage discharge fixture (0651-TF11) to disarm the capacitor by hooking
the high-voltage ground (TP1) with the black probe of the fixture, and hooking the
high-voltage socket (TP3) with the fixtures red probe. Wait till the indicating lamp on
the fixture turns off. The capacitor is not completely discharged if the indicator remains
on.
2.
Set the multimeter to DC 1000V. Measure the discharge resistance to check if the
reading of the multimeter is lower than 30V. If yes, you can safely disassemble the
equipment now.
TP3
TP1
7-9
Disconnect the cables from the therapy port and the capacitor.
2.
Loose and remove the six M48 Philips screws. Remove the therapy module
high-voltage board.
High-voltag
e board
M48
Philips screw
WARNING
z
Before remove the therapy module high-voltage board, you must use the dicharge
fixture to discharge the capacitor first. If you do not have a discharge fixture,
disconnect AC mains and remove batteries, Wait for at least 2 hours before
removing the capacitor.
NOTE
z
When replacing the therapy module low-voltage and high-voltage boards, carefully
route the cable to the therapy port so that it comes out through the gaps of PBCAs
and insulation sheet. Make sure the cable is not pressed by the PCBAs.
Route the cables, making sure that the cables are placed in the gaps between the
PCBAs.
When connecting two PCBAs, align the connectors and make sure they are firmly
engaged.
7-10
Stand the equipment on the work surface, and remove the four M48 Philips screws. If
your MPM module has a fan on it, first disconnect the fan cable, and then remove the
four M48 Philips screws.
M48
Philips screws
2.
Disconnect the MPM cable and remove the MPM module assembly.
MPM module
assembly
MPM cable
7-11
Stand the equipment. Remove the 2 screws integrated with the left capacitor sheet metal
and the two M38 Philips screws. Remove the sheet metal and the CO2 module, if it is
configured. Remove the left capacitor.
Screws integra
ted with the
sheet metal
Left capacitor
sheet metal
M3X8 Philips
screws
Remove the insulation sheet for the power management board. Pull out the magnetic
ring. Disconnect the cable between the power management board and keypad board.
2.
Remove the six M420 blots and the two M38 Philips screws; remove the CPU board
assembly. To remove the data card, remove the M410 socket head screw.
M38 Philips
screws
For replacement,
place the magnetic
ring in the gap
between PCBAs
and rear case
M410 socket
head screws
7-12
3.
Remove the 4 M36 Philips screws. Separate the CPU board and power management
board.
M36 Philips
screws
CPU board
NOTE
z
To reassemble the CPU board assembly, pass the cable between the power
management board and AC/DC module through the gap on the rear housing; then
replace the CPU board assembly.
Carefully route the therapy port cable so that it comes out through the gap of
PBCA. Be careful not to press the cable under the PCBA. Make sure the magnetic
ring is fixed at the gap of the CPU board and rear housing.
7-13
Check that the battery elastic pad and the silicone pad are stuck in place.
Silicone
pads. Apply
glue here
before close
the rear case.
Battery
elastic pad
2.
Check that power supply waterproof pads 1, 2 and 3 are stuck in place.
Power supply waterproof pad 1
Power supply
waterproof pad 3
3.
Check that the white waterproof strip is adhered to the proper place.
White waterproof
strip (45 cm long)
7-14
To disassemble the equipment, place the equipment on a work surface free from
foreign material, avoiding damaging the antiglare screen, LCD and the knobs.
After repairing any other front housing assembly, verify that the speaker is not
damaged by powering on the equipment and testing the speaker.
Cut the cable tie. Remove the seven M38 Philips screws and remove the front housing
sheet metal.
M38
Philips screws
7-15
Front housing
metal sheet
2.
Disconnect all the cables. Before disconnecting the rotary encoder cable, remove the
hot-melt glue using the sharp nose pliers.
When reassembling,
apply hot-melt glue to
the cable connector
Encoder cable
3.
Remove the eight M38 Philips screws and remove the keypad board.
M38
Philips screws
NOTE
z
When reassembling the equipment, apply hot-melt glue to the rotary encoders
cable connector to help fastening the cable. Be careful not to damage the cables and
connectors when plugging and unplugging the cables. Properly route the cables
7-16
Disconnect the cables from the alarm lamp board and the indicating lamp board. Your
equipment may be configured with a Toshiba LCD, or Sharp LCD, or AU LCD.
Sharp LCD
Alarm lamp
board cable
Mode
Select knob
7-17
2.
Remove the display assembly from the front housing, Remove the LCD from the shield;
disconnect the cables; remove the LCD inverter.
Sharp LCD inverter
Toshiba LCD inverter
Cable between
the inverter and
keypad board
Cable between
the inverter and
keypad board
LCD cable
LCD cable
AU LCD
AU LCD
backlight board
Magnetic ring
between the inverter
and keypad board
LCD
NOTE
z
If Sharp LCD is configured, S15 on the keypad board should be short (soldering
temperature between 280 and 300 , soldering time no more than 3 seconds), as
shown below. If Toshiba or AU LCD is configured, the S15 should be open.
7-18
Sharp LCD:
S15 is short
3.
Disconnect the cables and separate the LCD from the rubber frame.
For Toshiba or AU
LCD, inverter cable
passes through this gap
NOTE
z
Be careful not to damage the rubber frame. Properly route the cables.
Protect the antiglare screen, LCD and the rotary knob from being scratched.
When reassembling the equipment, apply hot-melt glue to the displays cable
connector to help fastening the cable.
7-19
Remove the two M38 Philips screws. Take off the speaker bracket, and then remove
the speaker.
2.
After repairing any other front housing assembly, verify that the speaker is not damaged
by powering on the equipment and testing the speaker.
M38 Philips
screws.
M38 Philips
screws
7-20
Alarm lamp
shade
Use a sharp nose pliers to pull the Mode Select knob off its shaft. Loosen and remove
the nut and washer using a socket wrench. Disconnect the cable from the knob.
Knob
cable
Washer
and nut
with the
knob
NOTE
z
When replacing the Mode Select knob, check that it is aligned with the labeling.
Adjusting the knob using sharp nose pliers if necessary.
7-21
Pull the encoder off its shaft. Loosen and remove the nut and washer using a socket
wrench. Disconnect the encoder cable.
Encoder
cable
Washer and
nut with the
encoder
Rotary
encoder
Remove the two M36 Philips screws. Pull the recorder out of the recorder well.
Disconnect the cable from the recorder, and then remove the recorder.
Recorder
cable
M36 Philips
screws
7-22
Take care not to damage the plastic bolts and nuts when disassembling and
replacing the PCBAs of the MPM module.
M314 Philips
screws with 3
flat washer
NOTE
z
The new MPM module does not have a fan. For MPM module which is equipped
with a fan, remember to install the fan during reassembling the MPM module after
maintenance or upgrade.
7-23
If your equipment is configured with a Masimo SpO2 module, remove the three M314
Philips screws. Thus you can remove the Masimo SpO2 board, Masimo SpO2 adapter
board and Masimo PCBA stacking sleeves.
Masimo SpO2 board
Masimo PCBA
stacking sleeves
M314 Philips
screws
2.
Masimo SpO2
adapter board
If your equipment is configured with a Nellcor or Mindray SpO2 module, remove the
three M36 Philips screws. Thus you can remove the Nellcor or Mindray SpO2 module.
M36 Philips screws
NOTE
z
If your equipment is configured with the SpO2 module, remove the three M36 Philips
screws and a M312 plastic bolt. Remove the MPM module analog board.
M312 plastic
bolt
M36 Philips
screws
Analog board
2.
If your equipment is not configured with the SpO2 module, remove the three M36
Philips screws. Then you can remove the MPM module analog board.
M36 Philips
screws
7-25
Remove the 3 M315+6-8 plastic bolt and a M36 Philips screw. If your equipment is
configured with the NIBP module, disconnect the cable and then remove the MPM
module digital board.
M36 Philips
screws
MPM module
digital board
M3X15+6-8
plastic bolt
and insulation
flat washer
Pump
cable
7-26
NIBP valves
shield
Pump
Airway
connector
Linear valve
(white & black wires)
7-27
AC power input
cable
7-28
Remove the M36 Philips screw; disconnect the ground wire. Remove the M6 nut; the
power supply metal sheet; the 6 flat washer and the M6 nut in turn. Then you can
remove the grounding terminal.
Power supply
metal sheet
M6 nut
Ground wire
6 flat washer
+ M6 nut
2.
Make sure that the waterproof pad is properly applied when replacing the power supply
module.
Power module
waterproof pad 1
7-29
Remove the six M36 Philips screws, and then remove the microstream CO2 module
and the CO2 adapter board.
Microstream
CO2 adapter
board
Microstream
CO2 module
Bolt
M3X7+8-6
7-30
Remove the four M36 Philips screws, and then remove the Mindray CO2 module.
M36 Philips
screws
CO2 module
(M02B)
Bolt
M3X7+8-6
7-31
Remove the two PT26 crosshead tapping screws; take out the watertrap receptacle.
Watertrap
Receptacle kit
PT26 crosshead
tapping screw
2.
Remove the four PT26 crosshead tapping screws. Thus you can remove the watertrap
bracket.
Watertrap bracket
PT26 crosshead
tapping screw
NOTE
z
Make sure the waterproof sheet is properly applied when replacing the CO2
module in the equipment.
7-32
Loose the
4 snaps
Microstream
CO2 connector
Waterproof
sheet
Remove the four PT26 crosshead tapping screws, and then remove the CO2
compartment door.
2.
Make sure the waterproof sheet is properly applied when replacing the CO2 module in
the equipment.
Waterproof sheet
7-33
Loosen the two snaps and remove the recorder drive board.
Snaps
2.
Loosen and remove the two PT26 crosshead tapping screws. Disconnect the flexible
cable and the connection cable between the recorder drive board and recorder keypad
board. Remove the thermal print head and recorder drive board.
Thermal
print head
PT26 crosshead
tapping screw
Cable between
the recorder
drive board and
recorder keypad
board
Flexible cable
7-34
3.
Remove the two PT26 crosshead tapping screws, and then remove the keypad board.
PT26 crosshead
tapping screw
Keypad board
M38 Philips
screws
2.
Recorder drive
board
Disconnect the flexible cable and the connection cable between the recorder drive board
and recorder keypad board. Remove the recorder drive board.
Flexible cable
7-35
3.
Remove the two PT26 crosshead tapping screws; take out the print head.
Print head
mounting
plate
4.
PT2.66 crosshead
tapping screws
Remove the two M24 Philips screws and then remove the print head.
Remove the two PT26 crosshead tapping screws, and then remove the keypad board.
Keypad board
PT26 crosshead
tapping screws
7-36
Sternum
paddle label
2.
Apex paddle
labels
Remove the two PT314 crosshead tapping screws; and then remove the handle cover
and the P+R button.
Apex paddle
cover
PT314 crosshead
tapping screws
3.
Remove the PT314 crosshead tapping screw. Take off the button bracket; disconnect
the cable and remove the keypad board.
Apex paddle
button bracket
PT314 crosshead
tapping screw
Apex paddle
keypad board
Remove the two PT314 crosshead tapping screws; remove the handle cover and then
the P+R button.
Sternum
paddle cover
PT314
tapping screws
2.
Sternum paddle
P+R button
Remove the PT314 crosshead tapping screw. Take off the button bracket; disconnect
the cable and remove the keypad board.
Sternum paddle
button bracket
PT314 crosshead
tapping screw
7-38
Sternum paddle
keypad board
8 Parts
8.1 Introduction
This chapter contains the equipments exploded views and parts lists. It helps the engineer to
identify the parts during disassembling the equipment and replacing the parts. This manual is
based on the maximum configuration. Your equipment may not have some parts and the
quantity of the screws, stacking sleeves, and etc may be different with those included in the
parts lists.
The figure below shows the hardware architecture of the equipments main unit.
Main Unit
Front housing
assembly
Rear housing
assembly
Paddle tray
assembly
Other
assemblies
Front housing
Rear housing
Paddle tray
External
paddle set
Anti-glare screen
8.4" LCD
Handle kit
Lithium
battery
Paddle holding
reed
Hook mount
kit
MPM module
Handle reinforce
sheet metal
Navigation knob
Therapy module
assembly
Paddle sheet
metal
Recorder
CO2 module
Keypad board
Measurement module
panel assembly
Inverter
Capacitor assembly
Speaker
Indicating lamp shade
Alarm lamp board
Indicating lamp board
8-1
P/N
Description
801-0651-00006-00
801-0651-00010-00
801-0651-00101-00
801-0651-00102-00
801-0651-00103-00
801-0651-00105-00
801-0651-00106-00
801-0651-00107-00
801-0651-00108-00
8-2
Qty
1
(As configured)
SN
P/N
Description
Qty
801-0651-00037-00
12
Plastic plug
801-0651-00005-00
Flat washer
Spring washer
10
022-000012-00
Lithium batteries
11
12
Silicone tube
13
8-3
P/N
Description
Qty
(As configured)
20
801-0651-00026-00
Keypad board
0651-20-76783-51
8-4
SN
P/N
Description
Qty
area
0651-20-76783-52
049-000091-00
049-000092-00
049-000093-00
049-000094-00
049-000095-00
049-000097-00
049-000098-00
049-000096-00
049-000099-00
0651-20-76782-51
801-0000-00002-00
801-0000-00007-00
(As configured)
(As configured)
801-0651-00111-00
LCD, Sharp
801-0651-00138-00
LCD, AU
(As configured)
10
Reed, 92-047
11
LCD shield
12
Antiglare screen
13
14
15
801-0651-00044-00
16
17
801-0651-00043-00
18
19
20
1
(As configured)
5
6
7
8
8-5
(As configured)
SN
P/N
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
21
22
Description
Qty
Navigation knob
TR6F-30-67306
TR6F recorder
TR8A recorder
(As configured)
115-008103-00
8-6
SN
P/N
Description
Qty
23
24
Recorder frame
25
801-0651-00047-00
26
27
020-000004-00
Speaker
28
Indicator shade
29
801-0651-00032-00
30
801-0651-00027-00
Indicator board
31
Speaker pad
32
33
34
8-7
P/N
Description
Qty
801-0651-00038-00
801-0651-00141-00
009-001325-00
801-0651-00033-00
043-001116-00
Bolt, M420_7-8
8-8
SN
P/N
Description
Qty
801-0652-00033-00
801-0652-00034-00
1
(As configured)
10
042-005519-00
Right bracket
11
12
10
13
801-0651-00040-00
Capacitor assembly
M02B-30-64513
1,
801-0651-00078-00
(As configured)
801-0651-00009-00
801-0651-00012-00
801-0651-00013-00
801-0651-00014-00
801-0651-00015-00
801-0651-00016-00
801-0651-00017-00
801-0651-00018-00
801-0651-00116-00
801-0651-00119-00
801-0651-00120-00
16
17
Silicone tube
801-0651-00019-00
801-0651-00020-00
801-0651-00021-00
801-0652-00027-00
14
15
18
19
8-9
1
(As configured)
1
(As configured)
8-10
P/N
Description
Qty
Warning label 2
4
5
Instruction label
1
(As configured)
1
(As configured)
Silicone pad
043-001936-00
Rear housing
10
11
12
13
1
BeneHeart D6 main unit label
(As configured)
Service label
14
15
16
17
18
Electrode spring
8-11
P/N
Description
Qty
8-12
SN
P/N
Description
Qty
10
11
NIBP connector
12
13
14
Gas outlet
15
1
(As configured)
16
Watertrap bracket
17
801-0651-00042-00
Watertrap receptacle
9201-30-35923
(As configured)
18
8-13
8-14
P/N
Description
Qty
801-0651-00041-00
Grounding terminal
10
801-0651-00024-00
11
AC mains label
12
13
14
15
8-15
8-16
P/N
Description
Qty
801-0651-00022-00
801-0651-00088-00
0010-10-12275
Masimo M7 Board
801-0651-00002-00
801-0651-00003-00
801-0651-00004-00
801-0651-00085-00
1
(As configured)
1
(As configured)
1
2a
801-0651-00023-00
801-0651-00001-00
801-0651-00086-00
(As configured)
Insulating plate
10
11
12
13
14
Bolt, M316+8-8
15
16
Spring washer
17
Bolt, M314+8-10
18
19
20
21
8-17
(for Masimo
SpO2 board)
1
P/N
Description
Qty
Capacitor pad 2
Capacitor pad 1
8-18
P/N
Description
Qty
Remark
M02B-30-64513
Bolt, M37+8-6
Conductive foam
Parts that are included in the sidestream CO2 module kit, but not shown in above figure:
/
Gas outlet
Watertrap bracket
801-0651-00042-00
8-19
P/N
Description
Qty
Remark
2
3
9201-30-35908
801-0651-00078-00
Bolt, M37+8-6
Conductive foam
Parts that are included in the microstream CO2 module kit, but not shown in above figure:
/
Gas outlet
9201-30-35923
8-20
Refer to the
figure of
measurement
module
panel for
assembly
P/N
Description
Qty
Paddle tray
Spring washer
10
Flat washer
11
12
Spring washer
13
Flat washer
14
801-0651-00124-00
15
0651-21-77162
Handle (0651)
8-21
P/N
Description
Qty
8-22
P/N
Description
0651-20-76818-51
047-001597-00
047-001599-00
047-001601-00
047-001603-00
0651-20-76818-52
1
1
10
11
Silicone tube
047-001598-00
1
047-001604-00
8-23
Qty
1
(As configured)
3
1
P/N
Description
Qty
8-24
P/N
Description
0651-20-76849-51
047-001607-00
Qty
1
(As configured)
047-001608-00
047-001610-00
047-001611-00
047-001612-00
801-0651-00029-00
Silicone tube
10
11
8-25
1 (As configured)
1
P/N
Description
Qty
8-26
P/N
Description
Qty
Torsion spring
Silicone pad
Paddle cable
8-27
P/N
Description
Qty
Hook
Pin
Spring
Hook base
Sleeve
8-28
NOTE
z
Here we list most replacement parts. If you need more parts, please contact our
Customer Service Department.
Description
Qty
Front housing
801-0651-00026-00
Keypad board
0651-20-76783-51
0651-20-76783-52
049-000091-00
049-000092-00
049-000093-00
049-000094-00
049-000095-00
049-000097-00
049-000098-00
049-000096-00
049-000099-00
0651-20-76782-51
801-0000-00002-00
801-0000-00007-00
801-0651-00111-00
Sharp LCD
801-0651-00110-00
Toshiba LCD
801-0651-00138-00
AU LCD
(As configured)
801-0651-00044-00
Rotating encoder
801-0651-00043-00
801-0651-00047-00
020-000004-00
8-29
1
(As configured)
P/N
Description
Qty
801-0000-00032-00
801-0000-00027-00
801-0651-00038-00
801-0651-00141-00
801-0651-00040-00
Capacitor assembly
801-0651-00078-00
801-0651-00039-00
801-0651-00046-00
801-0651-00045-00
801-0651-00083-00
801-0651-00025-00
801-0652-00027-00
801-0652-00031-00
801-0652-00032-00
801-0652-00033-00
801-0652-00034-00
801-0651-00035-00
0000-10-11158
801-0651-00009-00
801-0651-00012-00
801-0651-00013-00
801-0651-00014-00
801-0651-00015-00
801-0651-00016-00
801-0651-00017-00
801-0651-00018-00
801-0651-00116-00
801-0651-00119-00
801-0651-00120-00
801-0651-00033-00
801-0651-00019-00
801-0651-00020-00
801-0651-00021-00
Rear housing
8-30
1
(As configured)
P/N
Description
Qty
801-0651-00084-00
801-0651-00042-00
9201-30-35923
801-0651-00041-00
Power seat
801-0652-00039-00
801-0651-00024-00
801-0651-00022-00
801-0651-00088-00
0010-10-12275
MASIMO M7 BOARD(MASIMOKIT)
801-0651-00002-00
801-0651-00003-00
801-0651-00004-00
801-0651-00085-00
801-0651-00023-00
801-0651-00001-00
801-0651-00086-00
M02B-30-64513
9201-30-35908
External paddle
801-0651-00006-00
801-0651-00010-00
801-0651-00101-00
801-0651-00102-00
801-0651-00103-00
801-0651-00105-00
801-0651-00106-00
801-0651-00107-00
801-0651-00108-00
1
(As configured)
Miscellaneous
801-0651-00037-00
022-000012-00
801-0651-00005-00
1
8-31
P/N
Description
Qty
TR6F-30-67306
TR6F recorder
115-008103-00
TR8A recorder
(As configured)
0651-20-77032
040-000413-00
040-000099-00
040-000098-00
801-0651-00007-00
Description
0651-20-76870
0651-20-76872
0651-20-76873
Recorder cable
0651-20-76874
AU LCD cable
0651-20-76875
0651-20-76878
0651-20-76886
0651-20-76888
0651-20-76898
Cable between the inverter and keypad board (for Sharp LCD)
0651-20-76871
0651-20-77133
LCD cable
0651-20-77134
0651-21-76883
0651-21-76884
0651-20-77166
0651-20-77165
9201-20-35932
009-000484-00
LCD cable
8-32
Acceptance Criteria
The power plug pins
No loose connections.
No physical damage to the cord.
deterioration to the cord.
No
A-1
Acceptance Criteria
No physical damage to the enclosure and
accessories.
Acceptance Criteria
No unusual noises (e.g., a rattle inside the case).
A-2
Preparation
1.
First select the test current that will be used for performing the Protective Earth
Resistance test by pressing AMPERES (SOFT KEY 3).
2.
Connect the test lead(s) between the RED input jack and the GREEN input jack.
3.
Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than 0.150
Ohms, it will store the reading and subtract it from all earth resistance readings taken at
the calibrated current.
If the calibration fails, the previously stored readings will be used until a passing calibration
has occurred.:
WARNING
z
During Earth Resistance testing, the DUT must be plugged into the 601PRO
front outlet. If the DUT fails Earth Resistance, discontinue tests and label the
device defective.
A-3
From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet.
2.
Attach the 601PRO RED input lead to the devices Protective Earth terminal or an
exposed metal area.
3.
4.
Press SOFT KEY 3 to select a test current (1AMP, 10AMP, or 25AMP). The selected
test current is displayed in the upper right corner of the display.
5.
Press START TEST to start the test. The test current is applied while resistance and
current readings are taken. This takes approximately 5 seconds.
6.
Press the print data key at any time to generate a printout of the latest measurement(s).
NOTE
z
When "Over" is displayed for Ohms, this signifies that a valid measurement was
not obtained because either an open connection was detected or that the
measurement was not within range. Readings greater than 9.999 Ohms will be
displayed as Over.
In Case of Failure
Once it reaches the limitation, stop using and inform the Customer Service Engineer for
analysis and disposal.
Limits
R = 0.1 Maximum
A-4
Earth Leakage Current, leakage current measured through DUT outlet Earth
Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage
current measured through DUT outlet Earth
There is no need to attach a test lead; the 601PRO automatically connects the measuring
device internally.
From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2.
Attach the device's applied parts to the 601PRO applied part terminals if applicable.
3.
Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins
immediately:
SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.
4.
Press the print data key at any time to generate a printout of the latest measurement.
A-5
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
Preparation
Perform a calibration from the Mains on Applied Part menu.
The following outlet conditions apply when performing this test:
A-6
WARNING
z
If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2.
3.
Press shortcut key 6. The Patient Leakage test is displayed, and the test begins
immediately.
4.
Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part
leakage current.
5.
Modify the configuration of the front panel outlet by pressing the appropriate SOFT
KEY on the 601PRO.
6.
Press the print data key at any time to generate a printout of the latest measurement.
NOTE
z
If the current test standard being used does not include Patient Leakage DC
readings, or the DC option is not enabled, then DC readings will not be available
through the APPLIED PART SOFT KEY selections. Refer to Chapter 8,
Standards and Principles.
For external or internal paddle, the patient leakage current test should be tested
when the EUT was charging.
A-7
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
10 A in Normal Condition
A-8
Normal Polarity;
Reversed Polarity
Preparation
To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2).
1.
Disconnect ALL patient leads, test leads, and DUT outlet connections.
2.
If the calibration fails, the previously stored readings will be used until a passing
calibration has occurred. Also, the esc/stop key has no effect during calibration.
3.
When the calibration is finished, the Mains on Applied Part test will reappear.
WARNING
z
High voltage is present at applied part terminals while measurements are being
taken.
A-9
From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601
2.
3.
Attach the red terminal lead to a conductive part on the DUT enclosure.
4/
5.
Select the desired outlet configuration and applied part to test using the appropriate
SOFT KEYS:
6.
7.
Press the print data key to generate a printout of the latest measurement.
NOTE
z
If all of the applied parts correspond to the instrument type, the applied parts
will be tied together and one reading will be taken. If any of the applied parts
differ from the instrument type, all applied parts will be tested individually,
based on the type of applied part. This applies to Auto and Step modes only.
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
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Limits
50 A
5000 A
Preparation
1.
From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO
front panel outlet, and turn on the device.
2.
3.
Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions
in Section 5 of this chapter).
4.
Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins
immediately. Display values are continuously updated until another test is selected.
5.
6.
Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part
leakage current:
7.
Modify the configuration of the front panel outlet by pressing the appropriate SOFT
KEY on the 601PRO:
8.
Press the print data key at any time to generate a printout of the latest measurement.
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NOTE
z
If the current test standard being used does not include Patient Auxiliary
Current DC readings, or the DC option is not enabled, then DC readings will not
be available through the APPLIED PART SOFT KEY selections.
For external or internal paddle, the patient auxiliary current test should be
tested when the EUT was charging.
In Case of Failure
Test the wall outlet; verify it is grounded and is free of other wiring abnormalities.
Notify the user or owner to correct any deviations. As a work around, check the other
outlets to see if they could be used instead.
If the leakage current measurement tests fail on a new unit and if situation can not be
corrected, submit a Safety Failure Report to document the system problem. Remove unit
from operation.
If all else fails, stop using and inform the Customer Service Engineer for analysis and
disposal.
Limits
A-12
Opened repair type, not modify the power board and patient circuit board: Test item 1, 2,
3, 4, 5, 9
Opened repair type, modify the power board or patient circuit board: Test item 1, 2, 3, 4,
5, 6, 7, 8, 9
Location:
Technician:
Equipment:
Control Number:
Manufacturer:
Model:
SN:
Date of Calibration:
Pass/Fail
Comments
Device Labelling
_____
Max 0.1
EARTH
Leakage
Normal condition(NC)
____A
Single Fault
condition(SFC)
____A
Max
NC:500A,
SFC:1000A
Patient
Leakage
Current
Normal condition(NC)
____A
Single Fault
condition(SFC)
____A
6*
7*
8*
Patient
Auxiliary
Current
Max
CF AP
NC:10A, SFC: 50A
BF AP
NC:100A, SFC: 500A
Max
CF AP: 50A
BF AP: 5000A
Normal condition(NC)
____A
Single Fault
condition(SFC)
____A
Max
CF AP
NC:10A, SFC: 50A
BF AP
NC:100A, SFC: 500A
Name/Signature: _________________________
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Date: ________________________
A-14