Lefarma Teramax Service Manual
Lefarma Teramax Service Manual
Lefarma Teramax Service Manual
Patient Monitor
Service Manual
Intellectual Property Statement
LEFARMA S.A. DE C.V. (hereinafter called Lefarma) owns the intellectual property rights to this product and
this manual. This manual may refer to information protected by copyrights or patents and does not convey any
licenseunder the patent rights of Lefarma, nor the rights of others. Lefarma does not assume any liability arising
out of any infringements of patents or other rights of third parties.
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.
Revision number: 1.0
Release time: October 2011
© LEFARMA S.A. DE C.V. All rights reserved.
I
FOR YOUR NOTES
II
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.
This manual is based on the maximum configuration; Therefore, some contents may not
apply to your monitor. If you have any question, please contact our Customer Service
Department.
Intended Audience
III
Abbreviations
Passwords
A password may be required to access different modes within the monitor. The passwords are
listed below:
User maintenance: 888888 (User adjustable)
Factory maintenance: 332888
Demo mode: 2088
Configuration mode: 315666 (User adjustable)
IV
Contents
1
3.3 Monitor Installation ......................................................................................................... 3-4
3.4 Preparation for Power On................................................................................................ 3-4
5 Troubleshooting................................................................................................................ 5-1
5.1 Introduction ..................................................................................................................... 5-1
5.2 Part Replacement ............................................................................................................ 5-1
5.3 Patient Monitor Status Check.......................................................................................... 5-1
5.4 Software Version Check.................................................................................................. 5-2
2
5.5 Technical Alarm Check ................................................................................................... 5-2
5.6 Troubleshooting Guide.................................................................................................... 5-2
5.6.1 Power On/Off Failures ....................................................................................... 5-2
5.6.2 Display Failures ................................................................................................. 5-3
5.6.3 Alarm Lamp Problems ....................................................................................... 5-4
5.6.4 Button and Knob Failures .................................................................................. 5-4
5.6.5 Sound Failures .................................................................................................... 5-5
5.6.6 Power Supply Failures ....................................................................................... 5-6
5.6.7 Recorder Failures ............................................................................................... 5-7
5.6.8 Interface Failures ................................................................................................ 5-8
5.6.9 SD Card Failures ................................................................................................ 5-8
5.6.10 Wired Network Failures ................................................................................... 5-9
5.6.11 WiFi Failures .....................................................................................................5-9
5.6.12 Software Upgrade Problems........................................................................... 5-10
5.6.13 Technical Alarm Messages..............................................................................5-10
3
6.6.3 Removing the Microstream CO2 module (Optional)........................................ 6-16
6.6.4 Removing the C.O. Module (Optional) ............................................................ 6-16
6.6.5 Removing the SpO2 Board ............................................................................... 6-17
6.6.6 Removing the Multi-parameter Board ............................................................. 6-17
6.6.7 Removing the Pump and Valve ........................................................................ 6-18
6.7 Removing the Parameter Connector Panel Assembly ................................................... 6-18
6.7.1 Removing the Mainstream CO2 Signal Cable (Optional) ................................ 6-18
6.7.2 Removing the Microstream CO2 Connector Assembly (Optional) .................. 6-19
6.7.3 Removing the Watertrap Base Assembly (Optional) ....................................... 6-19
6.7.4 Removing the Cables From the Parameter Connector Panel............................ 6-20
6.7.5 Removing the Recorder.................................................................................... 6-21
4
7.12 Rear Housing Subassembly (12 Inch) ......................................................................... 7-17
7.12.1 Exploded View ............................................................................................... 7-17
7.12.2 Parts List ........................................................................................................ 7-17
7.13 Rear Housing Subassembly (8 Inch) ........................................................................... 7-18
7.13.1 Exploded View ............................................................................................... 7-18
7.13.2 Parts List ........................................................................................................ 7-18
7.14 Battery Compartment Subassembly (12 Inch) ............................................................ 7-19
7.14.1 Exploded View ............................................................................................... 7-19
7.14.2 Parts List ........................................................................................................ 7-19
7.15 Battery Compartment Subassembly (8 Inch) .............................................................. 7-20
7.15.1 Exploded View ............................................................................................... 7-20
7.15.2 Parts List ........................................................................................................ 7-20
7.16 Battery Door Subassembly (8 Inch) ............................................................................ 7-21
7.16.1 Exploded View ............................................................................................... 7-21
7.16.2 Parts List ........................................................................................................ 7-21
7.17 TR6F Recorder Kit (8 Inch) ........................................................................................ 7-22
7.17.1 Exploded View ............................................................................................... 7-22
7.17.2 Parts List ........................................................................................................ 7-22
7.18 Parameter Module Assembly ...................................................................................... 7-23
7.18.1 Exploded View ............................................................................................... 7-23
7.18.2 Parts List ........................................................................................................ 7-23
7.19 Parameter Connector Panel Assembly ........................................................................ 7-25
7.19.1 Exploded View ............................................................................................... 7-25
7.19.2 Parts List ........................................................................................................ 7-25
7.20 Oridion Microstream CO2 Kit ..................................................................................... 7-26
7.20.1 Exploded View ............................................................................................... 7-26
7.20.2 Parts List ........................................................................................................ 7-26
7.21 Lefarma Sidestream CO2 Kit...................................................................................... 7-27
7.21.1 Exploded View ............................................................................................... 7-27
7.21.2 Parts List ........................................................................................................ 7-27
7.22 Capnostat Mainstream CO2 Kit .................................................................................. 7-28
7.22.1 Exploded View ............................................................................................... 7-28
7.22.2 Parts List ........................................................................................................ 7-28
7.23 Replacement Parts ....................................................................................................... 7-29
7.23.1 Main Unit ....................................................................................................... 7-29
7.23.2 Connecting Cables ......................................................................................... 7-31
5
A Electrical Safety Inspection ............................................................................................A-1
A.1 Power Cord Plug ........................................................................................................... A-1
A.1.1 The Power Plug ................................................................................................ A-1
A.2 Device Enclosure and Accessories ................................................................................ A-2
A.2.1 Visual Inspection .............................................................................................. A-2
A.2.2 Contextual Inspection....................................................................................... A-2
A.3 Device Labeling ............................................................................................................ A-2
A.4 Earth Leakage Test ........................................................................................................ A-3
A.5 Patient Leakage Current ................................................................................................ A-4
A.6 Mains on Applied Part Leakage .................................................................................... A-6
A.7 Patient Auxiliary Current .............................................................................................. A-9
A.8 Functional test ............................................................................................................. A-10
6
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious
injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 DANGER
There are no dangers that refer to the product in general. Specific “Danger” statements may
be given in the respective sections of this manual.
1.1.2 Warnings
WARNING
All installation operations, expansions, changes, modifications and repairs of this
product are conducted by Lefarma authorized personnel.
There is high voltage inside the equipment. Never disassemble the equipment
before it is disconnected from the AC power source.
When you disassemble/reassemble a parameter module, a patient leakage current
test must be performed before it is used again for monitoring.
The equipment must be connected to a properly installed power outlet with
protective earth contacts only. If the installation does not provide for a protective
earth conductor, disconnect it from the power line and operate it on battery power,
if possible.
Dispose of the package material, observing the applicable waste control regulations
and keeping it out of children’s reach.
1.1.3 Cautions
CAUTION
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
equipment’s 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
Refer to Operation Manual for detailed operation and other information.
The product bears CE mark indicating its conformity with the provisions of
the Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
1-3
Type CF applied part. Defibrillator-proof protection against electric shock.
1-4
2 Theory of Operation
2.1 Introduction
This patient monitor is designed to monitor a fixed set of physiological parameters including
ECG, respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide
(CO2).
Local Display
Defibrillator
Centeral Station
LAN
Remote Monitor
2-1
The above figure shows a system consists of the TERAMAX patient monitor and its
peripheraldevices. The TERAMAX patient monitor:
Can be used for monitoring the physiological parameters, giving alarms and reviewing
patient data, etc.
Supports recorder.
Supports nurse call signal, synchronization defibrillation signal, and analog output
signal.
Supports Wi-Fi module, wired network, remote view, and communication with the
Hyper Visor Central Monitoring System.
Supports a secondary display.
Supports external AC power source and an internal battery.
Supports clinical data acquisition, which has two ways: by SD card and by USB drive.
The system software should support data output function, for SD card is a built-in
device.
CAUTION
Use mounting brackets we supply or approve. If other compatible mounting
bracket is used, be sure it can be safely used on the patient monitor.
The mounting bracket should be installed by our qualified service personnel, or
engineers who have adequate knowledge on it.
If other mounting solution is used, the installation personnel and the customer
should verify if it can be safely used on the patient monitor, and the customer
assume the responsibility for any risk resulting from that.
2-2
2.2.2 Connectors for Peripheral Devices
On the back of the patient monitor you can find all connectors for peripheral devices.
5 6
1
3
4
2-3
2.3 Main Unit
The main unit of the patient monitor consists of two parts:
Front housing assembly: main board, keypad board assembly (knob), display,
touchscreen, alarm lamp board, power switch and indicator board.
Rear housing assembly: power board (AC/DC), battery pad, interface board, recorder,
speaker, multi-parameter module which includes three types of SpO2 stacking boards,
CO2 module, IBP/C.O. module.
2-4
2.4 Front Housing Assembly
LCD mount
Navigation knob
Main board
Key board
Touchscreen
control
board
Power switch
board
2-5
The main board has the following interfaces to connect other PCBAs:
Display signal interface
Backlight control interface
Key board interface
Alarm light interface
WIFI interface
SD storage card interface
Interface board interface (for external output, module communication, power supply,
and etc)
2-6
2.4.3 Power Switch and Indicator Board
The power switch and indicator board controls the patient monitor’s power switch. It has 3
groups of indicators which are used to indicate the status of AC mains and battery, as well as
the monitor’s power on/off status. The power switch and indicator board is connected with
the key board.
2.4.5 Display
TERAMAX 1000 / TERAMAX 2000 respectively supports 8-inch, 10-inch, and 12-inch
color LEDbacklight LCD. The display connects the main board through a display signal
cable and a backlight cable. The interface cables for the three types of patient monitors are
different and cannot be mixed.
The reliability of display signal cable is relatively poor. If display problem occurs, consider
first to replaced the display signal cable.
2-7
2.5 Back Housing Assembly
The back housing assembly mainly includes power management system, multi-parameter
collecting and processing system, recorder and speaker.
The power management system consists of three key components: AC/DC power board,
DC/DC and power management, battery and battery back board. The structure is shown as
below:
2-8
The brown circuits are placed on the connector board. The three boards will be introduced
respectively in the following:
The connector board is the signal center of the whole system. All boards in back housing
assembly needs to communicate with main board through the transfer of connector board.
The connector definitions are:
Multi-parameter module connector (2*7pin)
CO2 connector (5pin)
M03B-C.O. module connector (4pin)
Recorder (6pin)
AC-DC power board (2pin)
2-9
Battery back board (2*4pin)
Speaker (2pin)
External connector (directly welt on the board): network, USB, VGA, multi functional
connector
Main board connector (2*25pin)
Preformed serial
The battery back board transmits the signal of battery capacity and status into the internal
system. This patient monitor only supports lithium battery. The on-site detection of lithium
battery is achieved by the resistance inside the battery.
The patient monitor supports 11.1V lithium chargeable battery. The battery is located at the
base of patient monitor. The battery power is input into power module through battery
connector board, and then power module processes and forwards the power into each
components of the patient monitor. Two types of batteries are supported:
Current high-end lithium battery 4500mAh
New developed low capacity lithium battery 2600mAh
2-10
The battery is fool-proof for type and insertion. The patient monitor requires a battery of
correct type to be inserted in correct direction. Otherwise, the battery can not be loaded.
The multi-parameter module is connected to the connector board with a 2 x 7 pin cable to
supply power for the parameter module, communicate with the main board, and realize
analog output and Defib sync output. It adopts the DSP processor as the core. For ECG
applications, the self-developed Lefarma ECG_ASIC chip is used to realize 3/5/12-lead ECG,
and RESP (I/II lead selectable) measurement, which greatly simplifies the sampling and
control of ECG signals for the DSP.
As for NIBP, IBP, and TEMP measurement, the high-precision - ADC is used to realize
a direct sampling of corresponding parameter signals. Lefarma SpO2 measurement is realized
by a stacking connector. The Nellcor and Masimo SpO2 boards are also compatible with the
multi-parameter module, being connected through a BTB socket.
2-11
2-channel 3/5-lead ECG parameter (12-lead will be developed in the future), with
selectable I/II resp lead;
Lefarma /Nellcor/Masimo SpO2 powering and communication;
2-channel TEMP;
2-channel IBP;
NIBP parameter;
Algorithms for all parameters, communicating with the main board through UART
serial port; and,
4 parallel output interfaces: (1 for ECG, 2 for IBP, and the other for Defib sync output)
The ECG parameter is isolated separately while the others are protected from earth.
SpO2 board is used to collect SpO2 signals transmitted by the multi-parameter module and
process SpO2 algorithms.
2-12
Three gas modules, which can be selected in corresponding menu, are supported on the
patient monitor:
M02C sidestream module;
Capnostat mainstream CO2 module; and,
Ordion microstream CO2 module.
2.5.9 Recorder
The recorder receives data from the main board and then sends them to the thermal printhead
for printing. The recorder has a hardkey (starting/stopping recordings) and a green LED on its
front. It is connected with the main board.
Module Description
Power interface Introduces a DC from the main board.
Converts the input power into voltages that fit each module and then
Power module
forwards them to each module.
CPU Control the communications between modules.
Control the communications between the main board and the recorder
Signal interface
CPU.
Receives the control signals from the CPU and then forwards them to the
Motor drive circuit
step engines.
Key&LED interface Includes a button and an LED which are directly controlled by the CPU.
2-13
2.6 Speaker
The speaker provides sound for alarms, key strokes, heartbeats and pulse, and allows PITCH
TONE and multi-level tone modulation. It is connected with the main board and is directly
driven by the main board.
2-14
3 Unpacking and Installation
This chapter provides information you need to install a patient monitor ready for use.
The following pictures show the patient monitor and accessory packing.
Accessory packing
Main unit
Accessory packing
3-1
3.2 Preparation for Installation
3.2.1 Preparation for Installation Site
1. Ensure that the site meets all safety, environmental and power requirements
2. Check that required power sockets are available.
3. Check that a network connector is available if the defibrillator/monitor needs to be
connected to network.
WARNING
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
To avoid explosion hazard, do not use the equipment in the presence of flammable
anaesthetics, vapours or liquids.
CAUTION
The environment where the patient monitor will be used should be reasonably free
from vibration, dust and corrosive substances. If these conditions are not met, the
accuracy of the system may be affected and damage may occur.
3-2
The environmental specification is as follows:
Main unit
NOTE
The environmental specifications of unspecified parameters are the same as those
of the main unit.
3-3
3.2.2 Electrical Requirements
Check cables and power cords. Make sure that:
1. All system cables, power cords and power plugs are not damaged, and pins are not loose.
Otherwise, remove it from use.
2. The insulation of patient cables and leadwires is not damaged, and connectors are not
loose.
WARNING
Only power sockets with protective grounding can be used.
Frequency 50/60Hz
3-4
4 Testing and Maintenance
4.1 Introduction
To ensure the patient monitor always functions normally, qualified service personnel should
perform regular inspection, maintenance and test. This chapter provides a checklist of the
testing procedures for the patient monitor with recommended test equipment and frequency.
The service personnel should perform the testing and maintenance procedures as required
and use appropriate test equipment.
The testing procedures provided in this chapter are intended to verify that the patient
monitor meets the performance specifications. If the patient monitor or a module fails to
perform as specified in any test, repairs or replacement must be done to correct the problem.
If the problem persists, contact our Customer Service Department.
CAUTION
All tests should be performed by qualified service personnel only.
Care should be taken to change the settings in [User Maintenance] and [Factory
Maintenance] menus to avoid loss of data.
Service personnel should acquaint themselves with the test tools and make sure
that test tools and cables are applicable.
4-1
4.1.3 Preventative Maintenance
Below are preventative maintenance tests which need to be performed on the monitor. See
the following sections for detailed maintenance procedures.
Visual inspection
NIBP test and calibration
Microsteam and Sidestram CO2 test and calibration
Performance Tests
ECG test Performance test 1. If the user suspects that the measurement is
incorrect.
Calibration
2. Following any repairs or replacement of
Resp performance test relevant module.
3. At least once every two years.
Note: At least once a year is recommended for
SpO2 test NIBP and CO2.
Pressure check
Calibration
Temp test
Performance test
IBP test
Pressure calibration
4-2
C.O. test
Leakage test
Sidestream and
Microstream Performance test
CO2 tests
Calibration
Nurse call relay performance test If the user suspects that the nurse call or analog
Analog output performance test output does not work well.
Electrical Safety Tests
Other Tests
1. When first installed or reinstalled.
Power on test 2. Following any maintenance or the
replacement of any main unit parts.
1. When the touchscreen appears abnormal.
Touchscreen calibration
2. After the touchscreen is replaced.
Following any repair or replacement of the
Recorder check
recorder.
Functionality 1. When first installed.
Battery check
test 2. Whenever a battery is replaced.
4-3
4.2.2 NIBP Tests and Calibration
NIBP Accuracy Test
Tools required:
T-shape connector
Appropriate tubing
Balloon pump
Rigid Vessel with volume 500 ± 25 ml
Reference manometer (calibrated with accuracy equal to or greater than 1 mmHg)
Monitor Manometer
Tubing
Connector for NIBP cuff
Balloon pump
Rigid vessel
2. Before inflation, the reading of the manometer should be 0. If not, turn off the balloon
pump to let the whole airway open to the atmosphere. Turn on the balloon pump after
the reading is 0.
3. Select [Main Menu]→ [Maintenance >>]→ [NIBP Accuracy Test].
4. Check the manometer values and the monitor values. Both should be 0mmHg.
5. Raise the pressure in the rigid vessel to 50 mmHg with the balloon pump. Then, wait
for 10 seconds until the measured values become stable.
6. Compare the manometer values with the monitor values. The difference should be 3
mmHg. If it is greater than 3 mmHg, calibrate the monitor by referring to the NIBP
Calibration section.
7. Raise the pressure in the rigid vessel to 200 mmHg with the balloon pump. Then, wait
for 10 seconds until the measured values become stable and repeat step 6.
4-4
NOTE
You can use an NIBP simulator to replace the balloon pump and the reference
manometer to perform the test.
You can use an appropriate cylinder and a cuff instead of the rigid vessel.
NOTE
You should perform NIBP accuracy test and make sure the test result is pass prior
to NIBP leakage test.
Tools required:
NIBP cuff for adult patient
Appropriate tubing
Cylinder
Follow this procedure to perform the test:
1. Set [Patient Cat.] to [Adu].
2. Connect the NIBP cuff with the NIBP connector on the monitor.
3. Apply the cuff to the cylinder as shown below.
Cylinder
Monitor
4-5
You can either perform a manual leakage test:
1. Perform procedures 1-4 in the NIBP Accuracy Test section.
2. Raise the pressure in the rigid vessel to 250 mmHg with the balloon pump. Then, wait
for 5 seconds to let the measured values becoming stable.
3. Record the current pressure value and meanwhile use a time counter to count time.
Then, record the pressure value after counting to 60s.
4. Compare the two values and make sure the difference should not be greater than 6
mmHg.
NIBP Calibration
Tools required:
T-shape connector
Approprating tubing
Balloon pump
Metal Vessel with volume 500 ± 25 ml
Reference manometer (calibrated with accuracy equal to or greater than 1 mmHg)
All calibration results are displayed in the [Calibrate NIBP] menu. If the calibration fails,
check the test system for leakage and perform another calibration.
4-6
4.2.3 Sidestream and Microstream CO2 Module Tests and
Calibration
Leakage test
Follow this procedure to perform the test:
1. Turn on the patient monitor.
2. Wait until CO2 warmup is finished and then use your hand or other objects to
completely block the gas inlet of the module or watertrap. The sidestream and
microstream CO2 modules will behave as follows:
Sidestream: The alarm message [CO2 FilterLine Err] is displayed on the screen
after certain time. Block the gas inlet for another 30 s. If the alarm message does
not disappear, it indicates that the module does not leak.
Microstream: The alarm message [CO2 Purging] is displayed on the screen after
certain time. Block the gas inlet for another 30s. If alarm message [CO2
FilterLine Err] is shown, it indicates that the module does not leak.
Accuracy Test
Tools required:
A steel gas cylinder with 6±0.05% CO2 and balance gas N2
T-shape connector
Tubing
Follow this procedure to perform the test:
1. Turn on the patient monitor.
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. Enter [User Maintenance] → enter the required password → [Maintain CO2
Purging]→ [Calibrate CO2>>].
4. Connect the test system as follows:
Open to the air
Tubing
Relief valve
Monitor
Gas cylinder
4-7
5. Open the relief valve to vent standard CO2 and make sure that there is an excess gas
flow through the T-shape connector to air..
6. Check the realtime CO2 value is within 6±0.3% in the [Calibrate CO2] menu.
Calibration
Tools required:
A steel gas cylinder with 6±0.05% CO2 and balance gas N2
T-shape connector
Tubing
Tubing
Relief valve
Monitor
Gas cylinder
6. Open the relief valve to vent standard CO2 and make sure that there is an excess gas
flow through the T-shape connector to air.
7. In the [Calibrate CO2] menu, enter the vented CO2 concentration in the [CO2] field.
8. In the [Calibrate CO2] menu, the measured CO2 concentration is displayed. After the
measured CO2 concentration becomes stable, select [Calibrate CO2] to calibrate the
CO2 module.
4-8
If the calibration is finished successfully, the message [Calibration Completed!] is
displayed in the [Calibrate CO2] menu. If the calibration failed, the message [Calibration
Failed!] is displayed. In this case, perform another calibration.
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.
4-9
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 6±0.05%.
4-10
4.4 Module Performance Tests
4.4.1 ECG Tests and Calibration
ECG Performance Test
Tool required:
Fluke Medsim 300B patient simulator recommended
ECG Calibration
Tool required:
Vernier caliper
If necessary, you can print out the square wave and wave scale through the recorder and
then measure the difference.
4-11
4.4.2 Resp Performance Test
Tool required:
Fluke Medsim 300B 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
II as 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 ± 2 rpm.
NOTE
A functional tester cannot be used to assess the accuracy of a pulse oximeter
monitor. However, it can be used to demonstrate that a particular pulse oximeter
monitor reproduces a calibration curve that has been independently demonstrated
to fulfill a particular accuracy specification.
4-12
4.4.4 NIBP Tests
See section 1.2.2 NIBP Tests.
4-13
IBP Pressure Calibration
Method 1:
Tools required:
Medsim300B Patient simulator, MPS450, or other equivalent device
Dedicated IBP adapter cable (300B, P/N 00-002199-00) (use P/N 00-002198-00, if the
simulator is MPS450)
Method 2:
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. Zero the transducer. Then open the stopcock to the sphygmomanometer.
3. Press the Main menu button on the equipment’s front panel. Select
[Maintenance>>]→[Cal. IBP Press. >>]. Then configure IBP calibration value.
4. Inflate using the balloon pump until the reading of sphygmomanometer approximates
the preset calibration value.
4-14
Pressure transducer
3-way stopcock
IBP Module
Sphygmomanometer
5. Adjust the calibration value in the [Cal. IBP Press.] menu until it is equal to the
reading of sphygmomanometer
6. Select the [Calibrate] button to start a calibration
7. The message [Calibration Completed!] is displayed after a successful calibration. If
the calibration failed, the prompt [Calibration Failed!] will be displayed.
4-15
4.4.8 Mainstream CO2 Tests
NOTE
Make sure that the barometric pressure set in [Maintain CO2] of [User
Maintenance] accords with the local barometric pressure before performing
mainstream CO2 tests.
Tools required:
A steel gas cylinder with 6±0.05% CO2
A steel gas cylinder with compressed air or N2 (with standard concentration)
Two 3-way valves (power supply controlled)
Flowmeter
Power supply
Tube
4-16
Indication of numbers in the figure above:
5 Adjust the power supply and turn on/off 3-way valves to ensure that that only one
cylinder is connected to Mainstream CO2 sensor via 3-way valves at one time and the
flowmeter reading is stable and within 2-5L/min.
6 Switch between the two cylinders to connect Mainstream CO2 sensor at intervals of 6
-10s and check if the displayed CO2 value is within 6±0.05%.
1. Connect the nurse call cable to the Multifunctional Connector of the patient monitor.
2. Enter Demo mode. Then, select [Main Menu]→ [Maintenance >>]→ [User
Maintenance >>]→ enter the required password→ [Others >>].
3. In the [Others >>] menu, select [Nurse Call Setup >>] and then select all options of
[Alm Lev] and [Alarm Cat.] and set [Contact Type] to [Normally Open]
4. In [Nurse Call Setup >>] setup menu, set [Signal Type] to [Pulse]. Make the monitor
to generate an alarm and check that the oscillograph displays positive pulses of 1s
width when there is an alarm.
5. In [Nurse Call Setup >>] setup menu, set [Signal Type] to [Continuous].Make the
monitor to generate an alarm and check that the oscillograph outputs continuous high
level when there is an alarm.
4-17
4.6 Analog Output Performance Test
Tool required:
Patient simulator
Oscillograph
1. Connect the patient simulator to the monitor using an ECG or IBP cable and connect
the oscillograph to the Multifunctional Connector of the patient monitor. Verify that
the waves displayed on the oscillograph are identical with those displayed on the
monitor.
1. Print ECG waveforms. The recorder should print correctly and the printout should be
clear.
2. Set the recorder to some problems such as out of paper, etc. the patient monitor should
give corresponding prompt messages. After the problem is removed, the recorder
should be able to work correctly.
4-18
3. Switch automatic alarm recording for each parameter ON and then set each
parameter’s limit outside set alarm limits. Corresponding alarm recordings should be
triggered when parameter alarms occur.
Function Test
1. If the patient monitor is installed with a battery, remove the battery first.
2. Verify that the patient monitor works correctly when running powered form an AC
source.
3. Insert the battery per the procedures provided in the Operator’s Manual.
4. Remove the AC power cord and verify that the patient monitor still works correctly.
Performance Test
Perform the test by referring to the Battery chapter in the Operator’s Manual and verify the
operating time of the battery meets the product specification.
4-19
4.11.3 Recorder
To enable/disable the recorder, select [Recorder] and toggle between [On] and [Off].
CAUTION
The recorder is disabled if [Recorder] is switched off in the [Factory Maintenance]
menu.
4-20
4.11.5 Monitor Information
Selecting [Monitor Information] will show the status of the patient monitor. Monitor
information is displayed as follows:
4-21
Maintenance and Test Report
(See the above sections for detailed test procedures and contents)
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. Effective date of calibration
Visual inspection
The case, display screen, buttons, knob, 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.
Power-on test
Performance test
4-22
ECG performance test
ECG waves are displayed correctly without noise and the HR
value is within 80±1 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
The Resp wave is not distorted and the Resp value is within
40±2 rpm.
SpO2 test
Measure SpO2 on a healthy person’s finger and a Pleth wave
and PR value are displayed. The displayed SpO2 value is
within 95%-100%
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.
Temp test
IBP test
The static pressure value displayed for each IBP channel is
within 200±2 mmHg.
The ART and LV waves for each IBP channel are displayed
correctly.
C.O. test
The TB value displayed on the monitor is within 37±0.1ºC.
The displayed C.O. value is within 5±0.25L/min.
4-23
Sidestream CO2 test
Block the gas inlet 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 6±0.3%.
Touchscreen calibration
The touchscreen is calibrated successfully.
Recorder check
The recorder can print ECG waves correctly and the printout is
clear.
Set the recorder to some problems such as out of paper, paper
jam, etc. the monitor gives corresponding prompt messages.
After the problem is removed, the recorder is able to work
correctly.
Automatic alarm recording for each parameter functions
correctly when parameter alarms occur.
Battery check
4-24
5 Troubleshooting
5.1 Introduction
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 Customer Service Department.
5-1
5.4 Software Version Check
Some troubleshooting tasks may require you to identify the configuration and software
version of your patient monitor.
1. To view information on the system configuration and system software version, Select
[Main Menu]→[Maintenance>>]→[Software Version>>].
2. You can also view the information on system software version and module software
version by selecting [Main Menu]→[Maintenance>>]→[Factory Maintenance>>]
- enter the required password →[Software Version>>].
5-2
5.6.2 Display Failures
Symptoms Possible Cause Corrective Action
1. Check that cables from the display to the main
Integrated display Cables defective or board are correctly connected.
is blank but the poorly connected. 2. Check that the cables and connectors are not
patient monitor
damaged.
still works
Main board defective Replace the main board.
correctly.
Display defective Replace the display.
Replace the main board, or upgrade the main board
Main board error
with the upgrade software.
Images
1. Check that cables from the display to the main
overlapped or
Cables defective or board are correctly connected.
distorted
poorly connected. 2. Check that the cables and connectors are not
damaged.
1. Check that the cable between the display and the
Secondary display Cables defective or patient monitor is correctly connected.
does not poorly connected 2. Check that the cables and connectors are not
function or
damaged.
displays snows
Interface board defective Replace the interface board.
or flashing
specks The main board is
Replace the main board.
damaged.
5-3
Symptoms Possible Cause Corrective Action
Touch position Touchscreen not
Calibrate the touchscreen
invalid calibrated
5-4
5.6.5 Sound Failures
Symptoms Possible Cause Corrective Action
The key volume is set Select [Main Menu]→[Screen Setup >>], and set the
to zero. [Key Volume] to appropriate setting.
No hardkey 1. Check that cable between speaker and interface board is
or knob Cable defective or properly connected.
sound, or poorly connected 2. Check that connecting cables and connectors are not
hardkey or
damaged.
knob sound
Speaker failure Replace the speaker.
abnormal
Main board failure Replace the main board.
Interface board failure Replace the interface board.
1. Select [Main Menu]→[Maintenance >>]→[User
Maintenance >>]→enter the required password→
The alarm sound is set [Alarm Setup >>], and then in the popup menu, set
to zero. [Minimum Alarm Volume] to appropriate setting.
2. Select [Main Menu]→[Alarm Setup >>]→[Others],
No alarm
and set [Alm Volume] to appropriate setting.
sound or
alarm 1. Check that cable between speaker and main board is
sound Cable defective or properly connected.
abnormal poorly connected 2. Check that connecting cables and connectors are not
damaged.
Speaker failure Replace the speaker.
Main board failure Replace the main board.
Interface board failure Replace the interface board.
5-5
5.6.6 Power Supply Failures
Symptoms Possible Cause Corrective Action
Battery failure Replace battery.
1. Different battery
1. Check that the cable between battery
voltages
interface board and interface board is
2. Battery can not be Cable defective or
correctly connected.
fully charged poorly connected
2. Check that cables and connectors are not
3. Battery can not be
damaged.
recharged
Battery interface board
4. Battery on-site Replace the battery interface board.
failure
check abnormal
Interface board failure Replace the interface board.
1. Check that cables from interface board to
No voltage output power board, AC input to power board are
Cable defective or
from the main lead, correctly connected.
poorly connected
or the voltage output 2. Check that cables and connectors are not
abnormal. damaged.
Power board failure Replace power board
No +12V output 1. Turn off the monitor then restart it.
2. If the problem remains, disconnect the AC
1. Power supply
mains for 5 s and reconnect it, then restart
protection
No +5.0 V output the patient monitor.
2. Power board failure
3. If the problem still remains, replace power
board.
NOTE
When the power module has a failure, it may cause problems to other components,
In this case, troubleshoot the power module per the procedure described in the
table above.
Components of the main unit are powered by the power module. In the event that a
component malfunctions, check if the operating voltage is correct.
5-6
5.6.7 Recorder Failures
Symptoms Possible Cause Corrective Action
1. Check if the recorder status LED lights
Recorder module
2. If yes, enable the module in [Factory Maintenance]
disabled
menu. Otherwise, check for other possible causes.
Paper reversed Re-install the paper roll.
1. Check that cable between recorder and main board is
No printout Cable defective or properly connected.
poorly connected 2. Check that connecting cables and connectors are not
damaged.
Recorder power Check if the power module outputs 5 V DC and 12V DC
supply failure correctly.
Recorder failure Replace the recorder.
Paper roll not
Stop the recorder and re-install the paper roll.
properly installed
Poor print
1. Check the thermal print head and the paper roller for
quality or
foreign matter.
paper not Print head dirty
2. Clean the thermal print head with an appropriate clean
feeding
solution.
properly
Print head failure Replace the print head.
Recorder failure Replace recorder.
5-7
5.6.8 Interface Failures
Symptoms Possible Cause Corrective Action
1. Check that cable between parameter
board and interface board is properly
Cable defective or
connected.
poorly conn ected
Analog output failure 2. Check that connecting cables and
connectors are not damaged.
Interface board failure Replace the interface board.
Parameter board failure Replace the parameter board.
1. Check that cable between interface
board and main board is properly
Cable defective or
connected.
1. USB device does not poorly connected
2. Check that connecting cables and
function (Assume that connectors are not damaged.
the peripheral devices
Interface board failure Replace the interface board.
are good)
Main board failure Replace the main board.
2. USB drive data
transfer failure Select [Main Menu]→[Maintenance >>]
→[User Maintenance >>]→enter the
Improper setup
required password→[Others >>], and set
[Data Transfer Method] to [USB Drive]
5-8
5.6.10 Wired Network Failures
Symptoms Possible Cause Corrective Action
Incorrect LAN cable Check LAN cable connection. LAN cable
connection shall not be longer than 50 m.
Incorrect IP address Check for IP address conflict. Reconfigure IP
configuration address.
1. Check that cable between interface board
Connection failure
Cable defective or and main board is properly connected.
poorly connected 2. Check that connecting cables and
connectors are not damaged.
Interface board failure Replace the interface board.
Main board failure Replace the main board
Frequent dropouts and Incorrect LAN cable Check LAN cable connection. LAN cable
network disconnects connection shall not be longer than 50 m.
Incorrect LAN cable Check LAN cable connection. LAN cable
The patient monitor is connection shall not be longer than 50m.
connected to a LAN Excessive requests for A patient monitor can only be viewed by 4
but cannot view viewing the patient other patient monitors at the same time
other patients under monitor at the same under the View Others mode. The excessive
the View Others time view requests system will be ignored.
mode Incorrect IP Check for IP address conflict. Reconfigure IP
configuration address.
5-9
5.6.12 Software Upgrade Problems
Symptoms Possible Cause Corrective Action
Power failure or
unintended power off
Boot file upgrade fails Return the main board to factory for repair.
during boot file
upgrade
1. Check that network connector on the
patient monitor is used.
Incorrect network 2. Make sure that the hub or switch run
connection normally. Check that net twines are of the
right type and have been connected
correctly.
Program upgrade fails
Wrong upgrade package Upgrade package shall be .pkg files. Select
has been downloaded package according to system requirement.
Configure a fixed IP address for the patient
Incorrect IP address monitor. We recommend not to upgrade a
configuration program when the patient monitor is
connected to a network with multiple PCs.
Battery abnormal after Fails to power cycle the Upgrade the power management software
upgrading the power patient monitor after again and then power cycle the patient
management program upgrading the power monitor.
management program
5-10
6 Disassembly and Repair
6.1 Tools Required
To disassemble and replace the parts and components, the following tools may be required:
Philips screwdrivers
Tweezers
Sharp nose pliers
Clamp
WARNING
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.
Follow correct sequence to disassembly the equipment. Otherwise, the equipment
may be damaged permanently.
Be sure to disconnect all the cables before disassembling any parts. Be sure not to
damage any cables or connectors.
Be sure to place removed screws and disassembled parts properly, preventing them
from being lost or contaminated.
6-1
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.
6-2
2. Separate the front housing assembly and rear housing assembly with caution.
Disconnect the cable between the main control board and key board and then take off
the front panel.
NOTE
When reassembling the equipment, be sure to check if the front housing
waterproof strip is correctly placed.
NIBP pipe
2. For equipments with optional C.O. and CO2 modules, remove the parameter module
assembly as described in 1.3.3 first.
6-3
6.3.3 Removing the Parameter Module Assembly
1. Lay the equipment on the work surface as shown below, and unscrew the four M4X10
screws:
2. Disconnect the multi-parameter signal cable, NIBP pipe, ECG signal cable, the cable
between the parameter board and interface board, CO2 communication cable (optional),
and the cable between the interface board and M03B module (optional) respectively, as
shown below:
6-4
3. For equipments with standard configuration, the parameter module assembly can be
removed directly.
Parameter
Parameter
module
connector panel
assembly
assembly
For those configured with C.O. function: disconnect the C.O. signal cable, and then
separate the parameter connector assembly and parameter module assembly, as shown below;
For those configured with mainstream CO2 function: disconnect the mainstream CO2
signal cable, and then separate the parameter connector assembly and parameter module
assembly, as shown below;
Mainstream CO2
signal cable
6-5
For those configured with microstream CO2 function: disconnect the CO2 pipe, take the
microstream CO2 connector assembly out from the parameter connector assembly, and then
separate the parameter connector assembly and parameter module assembly, as shown below:
CO2 pipe
For those configured with Lefarma M02C CO2 module: disconnect the CO2 pipe, pipe 1,
pipe 2, and the cable between the interface board and M02C module respectively, and then
separate the parameter connector assembly and the parameter module assembly, as shown
below:
CO2 pipe
Pipe 1
Communication cable
between interface board
and M02C module
Pipe 2
NOTE
All pipes should be assembled properly without occlusion during reassembly.
For equipments configured with optional C.O. or CO2 modules, be sure to remove
the parameter connector assembly and parameter module assembly together from
the rear housing and then separate the two module.
For those with standard configuration, remove the parameter module separately.
6-6
6.3.4 Removing the Battery Compartment Assembly
1. Loose and unscrew the four M3X6 screws as shown below. Disconnect the cable for
battery backboard and cable for AC/DC module, and then remove the battery
compartment assembly.
Cable for
battery back
board
Speaker cable
6-7
6.3.6 Removing the Recorder (Optional)
1. Unscrew the two M3X6 screws indicated below. Disconnect the recorder cable and
remove the recorder. The recorder can be removed separately without disassembling any
other components.
1. Check that the waterproof strip is properly stuck on the battery socket.
2. Check that the white waterproof strip is properly stuck on the front housing assembly.
6-8
6.4 Disassembling the Front Housing Assembly
NOTE
To disassemble the equipment, place the equipment on a work surface free from
foreign material, avoiding damaging the antiglare screen, touchscreen and the
knob.
Remember to install the screen support pad properly during reassembly.
Operations relating to optional parts may not apply to your equipment.
Position the touchscreen properly with the flexible cable facing down.
Touchscreen cable
Antenna
6-9
2. Remove the antennas from the Cyberlink module PCBA.
3. Put the clamps on the main control board aside and take out the Cyberlink module.
SD card
6-10
6.4.4 Removing the Main Control Board
1. Disconnect the alarm lamp cable, cable for display backlight, display cable, and the
cable between the main control board and keypad respectively. Unscrew the four M3X8
screws and take out the main control board, as shown below:
Screen cable
Touchscreen
6-11
6.4.6 Disassembling the Screen
1. Unscrew the ten M3X8 screws indicated below. Then take out the screen bracket.
2. Unscrew the four M3X8 screws indicated below to remove the screen.
Encoder cable
6-12
6.4.8 Removing the Encoder
1. Poke the encoder knob out from the slot and loose the nut with a sharp nose plier. Take
out the encoder.
Encoder
nut
Knob
6-13
6.5 Disassembling the Battery Compartment Assembly
6.5.1 Removing the Power Board
1. Disconnect the cable for AC input receptacle. Remove the three M3X6 screws indicated
below and remove the power board.
NOTE
Follow the instructions and unscrew the correct screws.
6-14
6.6 Disassembling the Parameter Module Assembly
NOTE
Perform disassembly with exercise care to protect the boards on both sides of the
module from damage.
Be sure to reassemble the fast valve (red) and slow vale (blue) in correct sequence.
The slow valve should be connected to the reducer-equipped end of the pipe.
Operations relating to optional parts, like C.O. and CO2, may not apply to your
equipment.
6-15
6.6.3 Removing the Microstream CO2 module (Optional)
1. Unscrew the four M3X6 screws indicated below and then take out the microstream CO2
module.
2. Then unscrew the three M3X6 screws and then take out the microstream converter, as
shown below:
6-16
6.6.5 Removing the SpO2 Board
1. Unscrew the two M3X6 screws indicated below and take out the SpO2 board.
6-17
6.6.7 Removing the Pump and Valve
1. Clip the cable holders indicated below with a clamp and take out the pump.
2. Push the four clamps indicated below aside and take out the valve.
Mainstream CO2
connecting board
6-18
2. Screw the connector of the mainstream signal cable clockwise with a sharp nose plier.
Pull the connector up to remove the mainstream signal cable.
Mainstream CO2
signal cable
(Optional)
1. Push the four clamps aside as shown below and take out the microstream CO2 interface
assembly.
Microstream CO2
connector assembly
6-19
2. Unscrew the four PT2X6 screws indicated below and take out the watertrap base
bracket.
Panel
1. To remove the cables, loose the connectors clockwise with a sharp nose plier; To
reassemble the cables, screw the connectors counter-clockwise to the correct sockets as
shown below:
ECG interface
TEMP 1
TEMP 2
IBP 1
IBP 2
6-20
6.7.5 Removing the Recorder
1. Push the two clamps aside and take out the recorder drive board, as shown below:
Clamps
Recorder drive
board
2. Unscrew the two PT2X6 screws and disconnect the cable between the recorder drive
board and recorder keypad and the flexible cable, as shown below. Then remove the
thermal print head and recorder drive board.
3. Unscrew the two PT2X6 screw indicated below and take out the keypad.
Keypad
6-21
FOR YOUR NOTES
6-22
7 Parts
7.1 Introduction
This section contains the exploded views and parts lists of the main unit. It helps the engineer to
identify the parts during disassembling the patient monitor and replacing the parts. This manual is
based on the maximum configuration. Your equipment may not have same parts and the quantity
of the screws or stacking sleeves etc. may be different with those included in the parts lists.
7-1
7.2 Main Unit (10"/12")
7.2.1 Exploded View
7-2
/ Front panel subassembly (10 Inch/Touchscreen)
/ Front panel subassembly (10 Inch/touchscreen/1G SD)
/ Front panel subassembly (10 Inch/touchscreen/WiFi)
/ Front panel subassembly (10 Inch/touchscreen/WiFi+ 1G SD
card)
/ Front panel subassembly (10 Inch/VGA/USB)
/ Front panel subassembly (10 Inch/Touchscreen)
2. / Rear housing of the main unit (12 inch/single network connector)
As
/ Rear housing of the main unit (12
configured
inch/Network/VGA/USB/Anolog input & output)
3. / Cross pan head screw M4X10 5
4. / TERAMAX 1000 / 2000 rear label (CN) 1
5. 9211-20-87369 AC Inlet Hook 1
7-3
3. / TERAMAX 1000 / 2000 rear label (CN) 1
4. / Cross pan head screw M4X10 5
7-4
9. / Screw, self-tapping, PT3X8 9
10. 051-000878-00 6301 keyboard PCBA 12.1 inch 1
11. 049-000335-00 Key (12 inch-Chinese) As
049-000351-00 Key (12 inch-English) configured
049-000385-00 Key (12 inch-Italian)
049-000386-00 Key (12 inch-Spanish)
049-000387-00 Key (12 inch- Portuguese)
049-000388-00 Key (12 inch-French)
049-000389-00 Key (12 inch-German)
12. 0010-30-43089 Encoder 1
13. 801-6301-00010-00 Front housing assembly (12 inch touchscreen) 1
14. 043-001790-00 Knob 1
15. / FUJI 12 Touchscreen long position pad 2
16. / Alarm lamp shade 1
17. 115-010845-00 Antenna and cable assembly 2
18. / Alarm gasket 1
19. 801-6301-00005-00 6301 alarm board PCBA 1
20. / FUJI12 Touchscreen short position pad 2
21. / 12 inch touchscreen short gasket 2
22. / 12 inch touchscreen long gasket 2
23. 021-000059-00 touch-panel, resitive-type, 12.1", 4-line 1
7-5
7.5 Front Housing Subassembly (12 Inch/Nakescreen)
7.5.1 Exploded View
7-6
10. 049-000335-00 Key (12 inch-Chinese) As
049-000351-00 Key (12 inch-English) configured
049-000385-00 Key (12 inch-Italian)
049-000386-00 Key (12 inch-Spanish)
049-000387-00 Key (12 inch-Portuguese)
049-000388-00 Key (12 inch-French)
049-000389-00 Key (12 inch-German)
11. 043-001790-00 Knob 1
12. 801-6301-00009-00 Front housing (12 inch) 1
13. / Alarm lamp shade 1
14. / Alarm gasket 1
15. 801-6301-00005-00 6301 alarm board PCBA 1
16. / 12 inch nakescreen long gasket 2
17. / 12 inch nakescreen short gasket 2
7-7
7.6.2 Parts List
SN P/N Description Qty
1. / Screw, pan head cross recessed M3X6 1
2. 051-000881-00 6301 touch control board PCBA 1
3. 801-6303-00001-00 6301 main control PCBA (complete, 10 inch) As
801-6303-00002-00 6301 main control PCBA (standard, 10 inch) configured
4. / Cross pan head screw with washer, GB9074.5, M3X8 16
5. 801-6303-00003-00 AU LCD service kit (LED backlight, 10 inch As
touchscreen) configured
801-6303-00010-00 Tianma LCD service kit (10 inch touchscreen)
6. / Spring, EMI 1
7. 021-000005-00 Touch panel 1
8. / Screw, self-tapping, PT3X8 9
9. 6802-20-66691-51 Power button (T5, mould MR66691) 1
10. / DMC touchscreen position pad 2
11. 051-000878-00 6301 keyboard PCBA 12.1 inch 1
12. 0010-30-43089 Encoder 1
13. 043-001790-00 Knob 1
14. 801-6303-00005-00 Front housing assembly (10 inch touchscreen) 1
15. / Alarm lamp shade 1
16. 115-010845-00 Antenna and cable assembly 2
17. 049-000335-00 Key (12 inch-Chinese) As
049-000351-00 Key (12 inch-English) configured
049-000385-00 Key (12 inch-Italian)
049-000386-00 Key (12 inch-Spanish)
049-000387-00 Key (12 inch-Portuguese)
049-000388-00 Key (12 inch-French)
049-000389-00 Key (12 inch-German)
18. / Alarm gasket 1
19. 801-6301-00005-00 6301 alarm board PCBA 1
20. 051-000880-00 6301 On/Off key board PCBA 1
21. / 10 inch touchscreen long gasket 2
22. / DMC touchscreen position pad 2
23. / 10 inch touchscreen short gasket 2
7-8
7.7 Front Housing Subassembly (10 Inch/Nakescreen)
7.7.1 Exploded View
7-9
8. 0010-30-43089 Encoder 1
9. 801-6303-00004-00 Front housing assembly (10 inch nakescreen) 1
10. 043-001790-00 Knob 1
11. / Alarm lamp shade 1
12. / Alarm gasket 1
13. 051-000878-00 6301 keyboard PCBA 12.1 inch 1
14. 801-6301-00005-00 6301 alarm board PCBA 1
15. 6802-20-66691-51 Power button (T5, mould MR66691) 1
16. 051-000880-00 6301 On/Off key board PCBA 1
17. / 10 inch nakescreen long gasket 2
021-000014-00 LCD, TFT 10.4” 800*600
7-10
7.8.2 Parts List
SN P/N Description Qty
1. 043-001790-00 Knob 1
2. 801-6302-00006-00 Front housing assembly (8 inch touchscreen) 1
3. / 6301 Antenna attached PCB 2
4. / Antenna, 2400-2500 MHz, 2.15 dBI, IPEX-II 2
5. 0010-30-43089 Knob 1
6. 049-000350-00 Key (8 inch-English) As
049-000334-00 Key (8 inch-Chinese) configured
049-000380-00 Key (8 inch-Itanlian)
049-000381-00 Key (8 inch-Spanish)
049-000382-00 Key (8 inch-Potuguese)
049-000383-00 Key (8 inch-French)
049-000384-00 Key (8 inch-German)
7. 051-000877-00 6301 keyboard PCBA 8.4 inch 1
8. / Screw, self-tapping, PT3X8 8
9. 9200-21-10460 Encoder connection cable 1
10. / Screw, Pan head w/washer, Phillips M3X6 14
11. / PCB shielding insulator 1
12. / PCB-shielding 1
13. 801-6302-00001-00 6301 main control PCBA, complete, 8 inch As
801-6302-00002-00 6301 main control PCBA, standard, 8 inch configured
14. 051-000881-00 6301 touch control board PCBA 1
15. / Screw, pan head cross recessed M3X6 1
16. / Screen bracket (8 inch touchscreen) 1
17. 801-6302-00003-00 AU LCD service kit, LED-Backlight, 8 inch As
touchscreen configured
801-6302-00013-00 Truly LCD service kit, 8 inch touchscreen
18. / Screw, M2.5x6, display 4
19. / LCD-PORON-L 2
20. / LCD-PORON-S 2
21. 021-000058-00 Touch-panel, resitive-type, 8.4" 4-line 1
22. / Long gasket, IPM8, touchscreen 1
23 / Short gasket, IPM8, touchscreen 1
24. 051-000880-00 6301 On/Off key board PCBA 1
25. 6802-20-66691-51 Power button 1
26. 801-6301-00005-00 6301 alarm board PCBA 1
27. / Alarm gasket 1
28. / Alarm lamp shade 1
7-11
7.9 Front Housing Subassembly (8 Inch/Nakescreen)
7.9.1 Exploded View
7-12
7. 051-000877-00 6301 keyboard PCBA 8.4 inch 1
8. / Screw, self-tapping, PT3X8 8
9. 9200-21-10460 Encoder connection cable 1
10. / Spring, EMI 1
11. / PCB shielding insulator 1
12. / Screw, Pan head w/washer, Phillips M3X6 12
13. / PCB-shielding 1
14. 801-6302-00001-00 6301 main control PCBA, complete, 8 inch As
801-6302-00002-00 6301 main control PCBA, standard, 8 inch configured
15. / Screw, pan head cross recessed M3X6 1
16. / Screen bracket (8 inch nakescreen) 1
17. 021-000060-00 LCD TFT 8.4" 800*600 LED-Backlight As
021-000078-00 LCD TFT 8.4” 800*600 3.3v 345cd/m2 LED backlight configured
18. / Screw, M2.5x6, display 4
19. / LCD-Gasket-L 2
20. / LCD-Gasket-S 2
21. 051-000880-00 6301 On/Off key board PCBA 1
22. 6802-20-66691-51 Power button, T5 (MR66691) 1
23. 801-6301-00005-00 6301 alarm board PCBA 1
24. / Alarm gasket 1
25. / Alarm lamp shade 1
7-13
7.10 Rear Housing Subassembly (12 Inch)
7.10.1 Exploded View
7-14
6. / Spring, EMI 3
7. / Earth bracket 1
8. 115-010373-00 Battery compartment subassembly (12 Inch) 1
9. / Screw, Pan Head W/Washer, Phillips M3X6 4
10. / Recorder bracket (12 inch) 1
11. 801-6301-00001-00 PCBA, Power management/interface board, complete As
801-6301-00001-00 PCBA, Power management/interface board, standard configured
12. / Screw, Pan Head W/Washer, Phillips M3X6 6
13. TR6F-30-67306 TR6F recorder 1
14. 047-005546-00 Label (standard)
047-005756-00 Label (Standard + IBP)
047-005757-00 Label (Standard + C.O.)
047-005758-00 Label (Standard + non-mainstream CO2)
047-005759-00 Label (Standard + mainstream CO2)
047-005760-00 Label (Standard + C.O. + non-mainstream CO2) As
047-005761-00 Label (Standard + C.O. + mainstream CO2) configured
047-005762-00 Label (Standard + IBP + C.O.)
047-005763-00 Label (Standard + IBP + non-mainstream CO2)
047-005764-00 Label (Standard + IBP + mainstream CO2)
047-005765-00 Label (Standard + IBP + C.O. + mainstream CO2)
047-005695-00 Label (Standard + IBP + C.O. + non-mainstream CO2)
7-15
7.16 Rear Housing Subassembly (8 Inch)
7.11.1 Exploded View
7-16
7.17 Rear Housing Subassembly (12 Inch)
7.12.1 Exploded View
7-17
9. / Gasket, speaker pressure plate and spacer 1
10. / Screw, Pan Head W/Washer, Phillips M3X6 2
11. / Gasket, speaker spacer 1
12. / Rubber feet 4
13. 115-010376-00 Battery door (12 inch) 1
14. / Battery door belt 1
7-18
8. / Handle waterproof pad 2
9. / Handle bracket 2
10. 020-000015-00 Speaker, 2W, 4ohm, 60mm 1
11. / Gasket, speaker pressure plate and spacer 1
12. / Gasket, speaker spacer 1
13. / Screw, Pan head w/washer, Phillips M3X6 2
7-19
9. / M4X8 combined screw 1
10. / Power board insulator 1
11. / Screw, Pan head w/washer, Phillips M3X6 3
12. 051-000824-00 6301 AC/DC power supply PCBA 1
13. / Spring, EMI 2
7-20
7. / M4X8 combined screw 1
8. / Conductive sponge 1
9. / Spring, EMI 5
10. / Battery Spring (8 inch) 1
11. / Power board insulator 1
12. 051-000824-00 6301 AC/DC power supply PCBA 1
13. / Screw, Pan head w/washer, Phillips M3X6 5
14. / Knob, battery latch 1
7-21
7.17 TR6F Recorder Kit (8 Inch)
7.17.1 Exploded View
7-22
7.18 Parameter Module Assembly
7.18.1 Exploded View
7-23
7. / Screw, Pan Head Cross Recessed M3X6 2
8. / Connector, Elbow, 200Barb, 3/32"ID, White Nylon 1
9. / NIBP pipe 2 1
10. / NIBP pipe 7 1
11. / Connector, Straight, 400Barb, 3/32"ID, White 3
12. / Airway tube 2 1
13. / NIBP pipe 5 1
14. / NIBP pipe 3 1
15. / Filter, inline filter 43um 1/8” I.D.Tubing 1
16. / NIBP pipe 6 1
17. / Connector, Tee, 200Barb, 3/32"ID, White Nylon 1
18. / NIBP pipe 4 1
19. / Pump cushion 1
20. 082-000862-00 Pump, 12V DC, with 120 mm wire and connector 1
21. / Cable holder, CHS-4X150mm, Nylon 2
22. M03B-30-26064 CO/IBP (M03B) module 1
23. / Lefarma sidestream CO2 kit As
/ Capnostat mainstream CO2 kit configured
/ Oridion microstream CO2 kit
24. / Screw, Pan Head Phillips M3X8 4
25. / 630F reducer 1
26. / Airway tube 1
27. 082-000861-00 Valve, CJV13-A12B1 1
7-24
7.19 Parameter Connector Panel Assembly
7.19.1 Exploded View
7-25
2. / NIBP pedestal (hexagon) 1
3. / Steel ball, 2.5 4
4. / Gas outlet 1
5. / AG watertrap receptacle As
/ Mainstream CO2 connecting board configured
9201-30-35923 Microstream CO2 connector assembly
6. / Parameter panel 1
7. / Nut, Stainless Steel M5 GB6170 1
8. / Silicon jacket 1
9. / NIBP external 1
10. 009-001678-00 ECG signal cable 1
11. 009-001993-00 C.O. signal cable 1
12. 009-001679-00 Multi-parameter signal cable, Lefarma As
009-001680-00 Multi-parameter signal cable (Nellcor SpO2+TEMP+IBP) configured
009-001681-00 Multi-parameter signal cable (Masimo SpO2+TEMP+IBP)
009-002123-00 Multi-parameter signal cable (Lefarma SpO2+TEMP)
009-002124-00 Multi-parameter signal cable (Nellcor SpO2+TEMP)
009-002125-00 Multi-parameter signal cable (Masimo SpO2+TEMP)
7-26
7.21 Lefarma Sidestream CO2 Kit
7.21.1 Exploded View
7-27
7.22 Capnostat Mainstream CO2 Kit
7.22.1 Exploded View
7-28
7.23 Replacement Parts
7.23.1 Main Unit
No. P/N Description Qty
1. 801-6301-00001-00 Power management/interface board (complete) 1
2. 801-6301-00002-00 Power management/interface board (standard) 1
3. 801-6302-00001-00 Main control PCBA (complete, 8 inch) 1
4. 801-6302-00002-00 Main control PCBA (standard, 8 inch) 1
5. 801-6303-00001-00 Main control PCBA (complete, 10 inch) 1
6. 801-6303-00002-00 Main control PCBA (standard, 10 inch) 1
7. 801-6301-00003-00 Main control PCBA (complete, 12 inch) 1
8. 801-6301-00004-00 Main control PCBA (standard, 12 inch) 1
9. 051-000878-00 6301 keyboard PCBA (12/10 inch) 1
10. 051-000877-00 6301 keyboard PCBA (8 inch) 1
11. 051-000880-00 6301 On/Off key board PCBA 1
12. 801-6301-00005-00 Alarm board PCBA 1
13. 051-000811-00 Cyberlink module PCBA 1
14. 051-000892-00 6301 Microstream converter PCBA 1
15. 051-000891-00 6301 battery interface PCBA 1
16. 051-000824-00 6301 AC/DC power supply PCBA 1
17. 051-000881-00 6301 touch control board PCBA 1
18. 801-6301-00006-00 MEC Multi-parameter PCBA (complete) 1
19. 801-6301-00007-00 MEC Multi-parameter PCBA (standard) 1
20. 051-000950-00 MEC Multi-parameter (complete) board PCBA 1
21. 051-000949-00 MEC Multi-parameter (standard) board PCBA 1
22. M03B-30-26064 C.O./IBP (M03B) module 1
23. 051-001038-00 Power isolation board PCBA of 6301 mainstream CO2 1
24. 051-000943-00 9008 V2.0 SpO2 board PCBA 1
25. 0010-30-43089 Encoder 1
26. 082-000861-00 Valve, CJV13-A12B1 1
27. 082-000862-00 Pump, 12V DC, with 120 mm wire and connector 1
28. 020-000015-00 Speaker, 2W, 4ohm, 60mm 1
29. 021-000058-00 Touch-panel, resitive-type, 8.4" 4-line 1
30. 021-000059-00 Touch-panel, resitive-type, 12.1" 4-line 1
31. 021-000005-00 Touch panel, resitive-type, 10.4" 4-line 1
32. 021-000060-00 LCD, TFT, 8.4", 800*600, LED-BackLight 1
33. 801-6302-00003-00 AU LCD service kit (8 inch touchscreen ) 1
34. 021-000061-00 LCD, TFT, 12.1", 800*600, LED-BackLight 1
35. 801-6301-00008-00 AU LCD service kit (12 inch touchscreen ) 1
36. 021-000062-00 LCD, TFT, 10.4", 800*600, LED-BackLight 1
37. 801-6303-00003-00 AU LCD service kit (10 inch touchscreen ) 1
7-29
38. 021-000078-00 8" LCD, Truly 1
39. 801-6302-00013-00 TRULY LCD kit (8 inch touchscreen) 1
40. 021-000014-00 10" LCD, TianMa 1
41. 801-6303-00010-00 AU LCD service kit (10 inch touchscreen ) 1
42. 0010-10-42633 12" AU LCD 1
43. 801-6301-00024-00 AU LCD service kit (12 inch touchscreen ) 1
44. 022-000053-00 Li-ion battery, 11.1, 2600mAh, LI13I001A 1
45. 023-000278-00 Industrial SD card (SLC), 1G 1
46. 040-001149-00 Masimo MS-2013 SpO2 board (For Lefarma 1
only)
47. 0010-10-42559 Microstream CO2 module, MiniMediCO2-9 1
48. M05-010R03--- Cell battery, Lithium, 3V, 35mAh, D12.5*2.0 1
49. 0671-00-0102-01 Nellcor SpO2 board (MDU) 1
50. 043-001790-00 Knob 1
51. 6802-20-66691-51 Power button 1
52. 049-000334-00 Key (8 inch-Chinese) 1
53. 049-000350-00 Key (8 inch-English) 1
54. 049-000380-00 Key (8 inch-Italian) 1
55. 049-000381-00 Key (8 inch-Spanish) 1
56. 049-000382-00 Key (8 inch-Portuguese) 1
57. 049-000383-00 Key (8 inch-French) 1
58. 049-000384-00 Key (8 inch-German) 1
59. 049-000335-00 Key (12 inch-Chinese) 1
60. 049-000351-00 Key (12 inch-English) 1
61. 049-000385-00 Key (12 inch-Italian) 1
62. 049-000386-00 Key (12 inch-Spanish) 1
63. 049-000387-00 Key (12 inch-Portuguese) 1
64. 049-000388-00 Key (12 inch-French) 1
65. 047-005546-00 Parameter label (standard) 1
66. 047-005756-00 Label (standard+IBP) 1
67. 047-005757-00 Label (standard+C.O.) 1
68. 047-005758-00 Label (standard+CO2) 1
69. 047-005759-00 Label (standard+Capnostat CO2) 1
70. 047-005760-00 Label (standard+C.O.+CO2) 1
71. 047-005761-00 Label(standard+C.O.+Capnostat CO2) 1
72. 047-005762-00 Label (standard+IBP+C.O.) 1
73. 047-005763-00 Label (standard+IBP+CO2) 1
74. 047-005764-00 Label (standard+IBP+Capnostat CO2) 1
75. 047-005765-00 Label (standard+IBP+C.O.+Capnostat CO2) 1
76. 047-005695-00 Label (standard+IBP+C.O.+CO2) 1
77. 049-000389-00 Key (12 inch-German) 1
78. 9211-20-87369 AC Inlet Hook 1
79. 9211-20-87402 Recording cover 1
7-30
80. 115-010355-00 Parameter panel subassembly 1
(ECG+TEMP+NIBP+ Lefarma SpO2)
81. 115-010356-00 Parameter panel subassembly (ECG+TEMP+NIBP+Nellcor 1
SpO2)
82. 115-010357-00 Parameter panel subassembly 1
(ECG+TEMP+NIBP+Masimo SpO2)
83. 115-010358-00 Parameter panel subassembly (ECG+TEMP+NIBP+ 1
Lefarma SpO2+IBP)
84. 115-010359-00 Parameter panel subassembly (ECG+TEMP+NIBP+Nellcor 1
SpO2+IBP)
85. 115-010360-00 Parameter panel subassembly 1
(ECG+TEMP+NIBP+Masimo SpO2+IBP)
86. 115-010376-00 Battery door subassembly (10/12 Inch) 1
87. 801-6302-00004-00 Battery door subassembly (8 inch) 1
88. 115-010845-00 Antenna cable 1
89. 801-6301-00009-00 Front Housing Subassembly (12 Inch/Nakescreen) 1
90. 801-6301-00010-00 Front Housing Subassembly (12 Inch/Touchscreen) 1
91. 801-6303-00004-00 Front Housing Subassembly (10 Inch/Nakescreen) 1
92. 801-6303-00005-00 Front Housing Subassembly (10 Inch/Touchscreen) 1
93. 801-6302-00005-00 Front Housing Subassembly (8 Inch/Nakescreen) 1
94. 801-6302-00006-00 Front Housing Subassembly (8 Inch/Touchscreen) 1
95. 115-010374-00 Rear cover subassembly (10/12 Inch) 1
96. 115-010391-00 Rear cover subassembly (8 Inch) 1
97. 801-6301-00011-00 Handle (10/12 inch) 1
98. 801-6302-00007-00 Handle (8 inch) 1
99. 115-010540-00 Watertrap pedestal assembly (M02C) 1
100. 115-010077-00 CO2 module unit (M02C) 1
101. 9201-30-35923 Microstream CO2 connector assembly 1
102. 115-010373-00 Battery compartment subassembly (12 inch) 1
103. 115-010390-00 Battery compartment subassembly (8 inch) 1
104. TR6F-30-67306 TR6F recorder 1
7-31
6. 009-001994-00 Mainstream CO2 signal cable 1
7. 009-001995-00 M02C sidestream communication cable 1
8. 009-001996-00 Cable between interface board and M03B moudle 1
9. 009-001997-00 Interface board to the mainstream converter 1
10. 009-001998-00 Interface board to Micro-stream board converter 1
11. 009-002000-00 Recorder cables 1
12. 009-002107-00 Cable for AC input receptacle 1
13. 009-002108-00 Cable for AC/DC module 1
14. 009-002109-00 Cable for touchscreen control board 1
15. 009-002112-00 Cable for display signal (AU 12") 1
16. 009-002115-00 Cable for backlight of 12.1〞display (AU) 1
17. 009-002116-00 Cable between mother board and alarm lamp 1
18. 009-002117-00 Cable between mother board and keypad 1
19. 009-002119-00 Cable between parameter board and interface board 1
20. 009-002123-00 Multi-parameter signal cable (Lefarma SpO2+TEMP) 1
21. 009-002124-00 Multi-parameter signal cable (Nellcor SpO2+TEMP) 1
22. 009-002125-00 Multi-parameter signal cable (Masimo SpO2+TEMP) 1
23. 009-002126-00 Cable between mother board and interface board 1
24. 009-002127-00 Cable between keypad and ON/OFF key board (12") 1
25. 009-002132-00 Cable for battery backboard 1
10 Inch
7-32
19. 009-002119-00 Cable between parameter board and interface board 1
20. 009-002123-00 Multi-parameter signal cable (Lefarma SpO2+TEMP) 1
21. 009-002124-00 Multi-parameter signal cable (Nellcor SpO2+TEMP) 1
22. 009-002125-00 Multi-parameter signal cable (Masimo SpO2+TEMP) 1
23. 009-002126-00 Cable between mother board and interface board 1
24. 009-002127-00 Cable between keypad and ON/OFF key board (12") 1
25. 009-002132-00 Cable for battery backboard 1
8 Inch
7-33
FOR YOUR NOTES
7-34
8 Upgrade
8.1 Introduction
You can upgrade parameter modules, functional assemblies and software by connecting the
patient monitor to a PC running the System Update Tool.
NOTE
If you have to disassemble the patient monitor for software upgrade, be sure to
eliminate the static charges before disassembling the equipment. When
disassembling the part labeled with a ESD warning symbol, 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.
Follow correct sequence to disassembly the equipment. Otherwise, the equipment
may be damaged permanently.
Disconnect all the cables before disassembling any parts. Be careful not to damage
any cables or connectors.
Properly place removed screws and disassembled parts, preventing them from
being lost or contaminated.
8-1
8.2 Upgrading Software
You can upgrade the software with the System Update Tool (PN: G-110-000493-00) through
network. This tool can directly run on a PC. Through network or by connecting the patient
monitor to a PC via a crossover network cable, you can upgrade the following programs:
Software PN Description
Boot program 110-001792-00 BIOS program
System software 110-001851-00 System software
Multilingual library 110-1795-00 Language library
110-001796-00 Icon library
BMP resource file
110-001847-00 Startup Logo
LINUX platform software 110-001848-00 LINUX kernel (including drive)
110-001861-00 M0 software for power management board
110-001839-00 BF512 software for M51A V2.0 module
110-000539-00 Software for 9008 SpO2 module
Module program
110-001838-00 STM32 software for M02C module
Software for M03B module (download
M03B-30-86661
online)
All programs except the module software will be cleared during the upgrade of LINUX
kernel (including drive). Therefore, remember to upgrade the system software and boot
program etc. after the LINUX kernel (including drive) is upgraded.
1. Connect the patient monitor to a PC through a network cable. Set the IP to 77.77.XX.XX
and subnet mask to 255.255.255.0.
2. Run the System Update Tool in the PC. Select [Miracle] in the [Machine Type Selection]
window and confirm.
3. Select [Select Package] in the main screen of the Lefarma Patient Monitor Software
Upgrade Tool. Choose the package you want to upgrade and click [Start].
4. Start up the patient monitor and press quickly the [Silence]+[Main Menu] hardkeys to
enter upgrade mode. Determine if the software is upgraded successfully according to the
prompt message of the patient monitor when finishing upgrading the software.
8-2
Software upgrade is taken in the sequence of LINUX kernel (including drive) → system
software package (including system software, language library, BMP resource files, and boot
program) →Module software.
For the details of software upgrade, refer to help and instructions for use of Lefarma Patient
Monitor Software Upgrade Tool.
CAUTION
Disconnect the patient monitor from patient and make sure important data are
saved before upgrade.
Do not shut down or power off the equipment when upgrading the boot program.
Otherwise, the equipment may break down.
Program upgrade should be performed by qualified service personnel only.
NOTE
After upgrading the BIOS program, you have to upgrade system program and
other programs to ensure compatibility.
Make sure the version of the upgrade package is you desired one. If you want to
obtain the latest upgrade package, contact Lefarma Customer Service Department.
8-3
FOR YOUR NOTES
8-4
A Electrical Safety Inspection
The following electrical safety tests are recommended as part of a comprehensive preventive
maintenance program. They are a proven means of detecting abnormalities that, if undetected,
could prove dangerous to either the patient or the operator. Additional tests may be required
according to local regulations.
All tests can be performed using commercially available safety analyzer test equipment.
These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent
safety analyzer. Other popular testers complying with IEC 60601-1 used in Europe such as
Fluke, Metron, or Gerb may require modifications to the procedure. Follow the instructions
of the analyzer manufacturer.
The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step if an approved agency status is to be maintained. The safety
analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line
voltage and grounding, as well as total current loads.
A-1
A.2 Device Enclosure and Accessories
A.2.1 Visual Inspection
Test Item Acceptance Criteria
No physical damage to the enclosure and
accessories.
No physical damage to meters, switches,
connectors, etc.
The enclosure and accessories
No residue of fluid spillage (e.g., water, coffee,
chemicals, etc.).
No loose or missing parts (e.g., knobs, dials,
terminals, etc.).
A-2
A.4 Earth Leakage Test
Run an Earth Leakage test on the device being tested before performing any other leakage
tests.
SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse.
SOFT KEY 2 toggles the DUT outlet from Earth to No Earth.
SOFT KEY 3 toggles the DUT outlet from L2 to No L2.
SOFT KEY 4 toggles the AP to Earth to No AP to Earth.
4. Press the print data key at any time to generate a printout of the latest measurement.
A-3
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
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.
Change another probe to confirm if the fail is caused by console.
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
For USA,
300 μA in Normal Condition
1000 μA in Single Fault Condition
Preparation
Perform a calibration from the Mains on Applied Part menu.
A-4
WARNING
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.
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
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.
A-5
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
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.
Change another probe to confirm if the fail is caused by console.
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
For CF applied parts
10μA in Normal Condition
50μA in Single Fault Condition
For BF applied parts
10μA DC,100μA AC in Normal Condition
50μA DC, 500μA AC in Single Fault Condition
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity;
Reversed Polarity
A-6
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. Press CAL to begin calibration, as shown:
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
A 2-beep-per-second signal indicates high voltage present at the applied part
terminals while a calibration is being performed.
High voltage is present at applied part terminals while measurements are being
taken.
A-7
5. Select the desired outlet configuration and applied part to test using the appropriate
SOFT KEYS:
6. Press START TEST (SOFT KEY 1) to begin the test.
7. Press the print data key to generate a printout of the latest measurement.
NOTE
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
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
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.
Change another probe to confirm if the fail is caused by console.
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
For CF applied parts: 50μA
For BF applied parts: 5000μA
A-8
A.7 Patient Auxiliary Current
Patient Auxiliary currents are measured between any selected ECG jack and the remaining
selected ECG jacks. All measurements may have either a true RMS or a DC-only response.
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. Attach the patient leads to the 601PRO ECG jacks.
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.
NOTE
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.
A-9
In Case of Failure
Check any broken of the enclosure. Replace any defective part.
Inspect wiring for bad crimps, poor connections, or damage.
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.
Change another probe to confirm if the fail is caused by console.
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
For CF applied parts,
10μA in Normal Condition
50μA in Single Fault Condition
For BF applied parts,
10μA DC, 100μA AC in Normal Condition
50μA DC, 500μA AC in Single Fault Condition
A-10
ELECTRICAL SAFETY INSPECTION FORM (American Version)
Overall assessment:
Scheduled inspection Test item: 1, 2, 3, 8
Unopened repair type Test item: 1, 2, 3, 8
Opened repair type, not modify the power part Test item: 1, 2, 3, 4,8
including transformer or patient circuit board
Opened repair type, modify the power part Test item: 1, 2, 3, 4, 5, 6, 7, 8
including transformer or patient circuit board
Location: Technician:
Location: Technician:
Note: The test items marked “*” are needed only for incoming inspections and after repairs or
modifications that may have affected lead leakage [NFPA 99 (2005)8.5.2.1.3].
Deficiency /Note: