Beruflich Dokumente
Kultur Dokumente
Patient Monitors
Service Guide
May 2009
English
1
Product Information
Standard
The product is made under the ISO9001 and ISO13485 quality system certified by
TUVPS.
Manufacturer Information
Version
The content of this manual can change without notice due to software upgrades.
■ Edition date: May 2009
Safety Conventions
The guide uses the following conventions for Notes, Cautions, and Warnings.
Caution A Caution calls attention to a condition or possible situation that could damage or destroy
the product or the user’s work.
Warning A Warning calls attention to a condition or possible situation that could cause injury to
the user and/or patient.
2
Explanation of Symbols
Humidity Caution
On/Standby Equipotential
button grounding
post
3
Table 1 Monitor Symbols(Continued)
Symbol Description Symbol Description
Param Menu Dangerous Voltage
button
EU Serial Number
representatives
Declaration
The G30 and G40 monitors are Class IIb devices and comply with the requirements
of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and
carry CE-marking accordingly.
Authorized EU Representative
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Tel: +49 40 2513175
Fax: +49 40 255726
4
Product Support and Warranty Information
Warranty period for the G30/G40 monitor is one year from the date of shipment.
Warranty is “parts only” and does not include any labor. Shipping of replacement
parts is included in the warranty. Warranty claims for parts require the return of the
defective materials to Goldway.
Accessories that are included with the product are warranted for 6 months from the
date of shipment of the original product. Warranty for accessories is “replacement”.
Keep the packaging in case you need it for transport, storage, or maintenance.
Goldway is responsible for the safety, reliability and performance of the monitor
when the:
• Product is assembled, upgraded, altered, or maintained by authorized service
representatives.
• Electric facilities where the monitor is placed are in conformity with the
national standard.
• Product is used according to this guide.
Goldway is not responsible for damage to the monitor when the:
• Damage is caused by:
– Improper operation.
– Improper connection of the monitor to other devices.
– Accident.
• Monitor is altered without written authorization from Goldway.
• Serial number of the monitor is removed or becomes illegible.
5
E-mail: service@goldwayinc.com
(English and Chinese ONLY)
Safety Standards
6
Contents
Table of Contents
Contents-1
Contents
2.4 Cleaning..................................................................................................................2-6
2.4.1 General Guidelines........................................................................................2-6
2.4.2 Cleaning and Disinfecting.............................................................................2-7
2.4.3 Cleaning the Cables ......................................................................................2-7
2.4.3.1 Cleaning the Accessories ...........................................................................2-7
2.4.3.2 SpO2 Accessories .......................................................................................2-8
2.4.3.3 NIBP Cuffs.................................................................................................2-9
2.4.3.4 Temperature Accessories............................................................................2-9
2.4.3.5 Cleaning the Recorder................................................................................2-9
2.4.3.6 Disinfecting Guidelines............................................................................2-10
2.5 Performance Verification Testing..........................................................................2-11
2.5.1 Manufacturer’s Responsibility ....................................................................2-11
2.5.2 Recommended Frequency...........................................................................2-11
2.5.3 Required Test Equipment............................................................................2-12
2.5.4 Testing Record ............................................................................................2-13
2.5.5 Power Supply and Battery Test ...................................................................2-13
2.5.6 ECG Test .....................................................................................................2-14
2.5.7 Respiration Test...........................................................................................2-14
2.5.8 Temperature Test .........................................................................................2-14
2.5.9 IBP Test.......................................................................................................2-15
2.5.10 Pulse SpO2 Test .........................................................................................2-15
2.5.11 NIBP Test ..................................................................................................2-15
2.5.12 Speaker Test ..............................................................................................2-17
2.5.13 Networking Test ........................................................................................2-17
2.6 Electrical Safety Test ............................................................................................2-17
Contents-2
Contents
Contents-3
Contents
Contents-4
General Introduction
1-1
General Introduction
1.2.1 General
The monitor collects the physiological signals of ECG, RESP, TEMP, NIBP, SpO2,
IBP, and CO2, and converts the above into digital data which is analyzed and
displayed. You may not have all of these functions, depending on the monitor
configuration purchased.
1-2
General Introduction
G30 G40
ECG
● ●
(3, 5 leads)
TEMP1
● ●
TEMP2
RESP ● ●
NIBP ● ●
SpO2 ● ●
CO2 ○ ○
IBP1
○ ○
IBP2
Arrhythmia analysis ● ●
ST segment analysis ● ●
Recorder ○ ○
Display Screen,
10.4 inches, 800×600 12.1 inches,800×600
Resolution
Max. Number of
1 2
Batteries
Maximum
8 8
Waveform Channels
● indicates standard configuration; ○ indicates optional configuration
1.2.4 Audience
You can use the G30/G40 Patient Monitors along with other Goldway equipment to
create a central monitoring system that allows remote monitoring. The monitor
communicates with the UT4800 Central Monitoring System via an RJ45 port on the
back of the monitor.
1-3
General Introduction
3. Examine the monitor for cleanliness and general physical condition. Make sure
that the:
– Housing is not cracked or broken.
– Power plugs and cords are in good condition and plug prongs are not bent.
– External cables and accessories are in good condition and that the insulation is
intact.
Caution If the equipment or packaging show signs of damage, do not use the equipment.
1. Before turning on the power, check the monitor and accessories to make sure there
is no damage and the extension cables are correctly connected to the fittings.
2. Plug one end of the power cord into an AC power supply with a protective
grounding wire. Plug the other end into the power connector on the monitor. If the
monitor is powered by batteries, make sure enough power remains.
3. Power on the monitor and enter the main screen after the start-up screen.
4. Ensure that the patient cable and sensors are correctly connected.
5. Ensure that all settings like patient type, alarm limits, and so on, are correct.
6. Test the measurements and verify that the monitor is working correctly.
1-4
General Introduction
Warning Never attempt to open the monitor case. Only qualified personnel should service the
monitor. Only use the instructions in this guide to install and use the monitor.
Caution To maintain normal operation of the monitor, develop a good maintenance plan for
periodic cleaning, maintenance and service. For more information, see Chapter 2
Maintenance.
1.5 Cleaning
Caution Do not immerse the monitor or its accessories in liquid or clean it with caustic or
abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories.
If it is necessary to return the monitor for service, call the Goldway Service
Department. Have all equipment serial numbers available before calling.
1-5
General Introduction
Place and use the monitor in any appropriate location that conforms to the
environmental specifications in the G30/G40 Patient Monitors Instructions for Use.
Caution Only install the monitor as outlined in this Service Guide. Never block the monitor’s air
vent during operation. Always keep the monitor free from condensation and
temperature changes when transporting it from one location to another.
You can put the monitor on a flat surface or mount it using the bedrail hooks. To
mount, place the monitor bedrail hooks over a secure horizontal bedrail.
Warning Never place the monitor in a location where the patient might inadvertently knock it off the
bed.
Warning Never disassemble the monitor before unplugging the power cable from the AC power
source or from the AC power connector on the side of the monitor.
After connecting the monitor to an AC power source, it can be put into operation.
Before turning on the monitor:
1. Ensure that the AC power source complies to any AC power regulations.
Note — Only connect the monitor to a power outlet with correct protective grounding. If no grounded
power is available, only use the monitor with internal batteries.
2. Connect the power cord to the monitor and to a single-phase AC power source.
3. Check that the power light on the front panel is yellow.
1-6
General Introduction
Warning Personnel connecting additional devices to input and output connectors are responsible
for system compliance with the IEC 60601-1-1 standard. If you cannot determine the
safety of the monitor when combining it with another medical device, contact Goldway to
ensure that the combined devices are safe and will not cause electric shock or other
hazards.
When safety (for example an electrical shock caused by the sum of current leakage)
can not be determined from the specific combination of the monitor and other
medical devices, please contact service representative, to ensure necessary safety.
Demo mode lets you demonstrate the monitor without monitoring parameters. Demo
mode does NOT generates alarms when alarm settings are exceeded.
To set the Demo mode:
1. Press the Main Menu key on the front panel.
2. Rotate the navigation wheel to System menu and press the navigation wheel.
3. The System menu appears, and then rotate the navigation wheel to Demo then
press the navigation wheel.
4. The Logging On menu appears and rotate the navigation wheel to the Password,
press the navigation wheel. A password window appears. Enter the password
(8727) by turning the wheel to select the digit, and then press the wheel to save
the first digit. Repeat this for the next three digits of the password.
5. Press OK.
1-7
General Introduction
1-8
Maintenance
Chapter 2 Maintenance
This chapter describes how to inspect and maintain the G30/40 Patient Monitors.
2-1
Maintenance
2-2
Maintenance
The following table lists the tests that Goldway requires to be completed after
performing monitor installations, repairs, or software upgrades.
Table 2-1 Testing and Inspection Guidelines
After … Complete These Tests …
Installing Visual inspection
Upgrading the software Power Supply and Battery Test
Opening the monitor for any Speaker Test
reason Power Supply and Battery Test
NIBP Test
All safety tests
Replacing any internal parts Power Supply and Battery Test
(except SpO2, CO2, ECG, NIBP Test
TEMP, IBP/TEMP module) Speaker Test
All safety tests
Replacing the ECG module Power Supply and Battery Test
ECG test
Speaker Test
Respiration Test
All safety tests
Replacing the SpO2 module Power Supply and Battery Test
Pulse SpO2 Test
All safety tests
Replacing the IBP/TEMP Power Supply and Battery Test
module IBP Test
IBP Calibration
Temperature Test
All safety tests
Replacing the TEMP module Power Supply and Battery Test
Temperature Test
All safety tests
Replacing the CO2 module Power Supply and Battery Test
Speaker Test
All safety tests
2-3
Maintenance
To maintain proper performance of the monitor, a good maintenance plan must be made.
We recommend the following:
Before use, operator shall first inspect the outside appearance of the equipment. Service
personnel shall first inspect the outside appearance of the equipment before
maintenance.
2.2.2 Cleaning
When monitor is received, a qualified person must inspect the monitor thoroughly and
verify its performance. Service personnel shall inspect the monitor thoroughly and
verify performance every time maintenance is done or every 12 months.
Service personnel shall inspect the monitor thoroughly every time when maintenance is
done or every 12 months.
Replace the cuff or hose as necessary. If a pressure reading, when compared with a
precise blood pressure meter, differs by more than 3% (beyond the range of ±3mmHg),
the monitor needs pressure calibration. Authorized personnel can perform the required
calibrations.
2-4
Maintenance
2-5
Maintenance
Before using the monitor, make sure to inspect the monitor carefully:
1. Carefully inspect the outside of the monitor, display and control parts to see if there
is any apparent physical damage. If yes, do not use the monitor. Please contact an
authorized service personnel and reflect the damage until problems are settled
before connect the monitor to patients.
2. Inspect all cables, connecting wires and external connectors. If there is any damage,
do not use the monitor. Please contact authorized service personnel and reflect he
damage until the problems are settled before connecting the monitor to patients.
2.4 Cleaning
This chapter gives general guidelines on the cleaning and care of your monitor and
accessories. Use only the approved cleaning methods and agents listed in this chapter.
The warranty does not cover damage caused by using unapproved substances.
Cleaning methods described in this chapter have been tested by Goldway. Other
methods and cleaning agents may contaminate or damage the monitor. In addition,
qualified professionals should perform calibration and maintenance of the monitor
periodically.
Keep the monitor, cables and accessories free of dust and dirt. After cleaning and
disinfecting, check the equipment carefully. Do not use if you see signs of
deterioration or damage. If you need to return any equipment to Goldway,
decontaminate it first.
2-6
Maintenance
• Never immerse any part of the equipment in liquid or allow any liquid to enter
electrical contacts.
• Never use abrasive material (such as steel wool or silver polish).
• Never use bleach, strong solvents, or acetone on any part of the monitor
• Never autoclave, steam sterilize, or ultrasonically clean the monitor or cables
• Never use alcohol on the patient cables. Alcohol can cause the plastic to
become brittle and fail prematurely.
Caution If you see any sign of deterioration or damage on any accessory, do not use it, and
replace it with a new one. Use the equipment according to instructions accompanied
with the sensors. The manufacturer information might be more current. If you spill
liquid on the exterior of the monitor, use a clean cloth to dry the monitor. If you believe
the liquid may be inside the monitor, power off the monitor and contact your service
representative.
2-7
Maintenance
SpO2 reusable sensors should be cleaned and disinfected, but never sterilized.
Warning Use only the validated cleaning agents and disinfectants listed below. Using other agents may
damage the sensor or its connecting wires, shorten product lifetime, or cause safety hazards.
Select disinfectants carefully as some have very similar names but very different compositions.
Never immerse the sensor connector in any of the cleaning solutions, disinfectants, or other
liquids. The sensor and cable housing may be immersed, however. Never soak sensors in
disinfectants longer than specified by the disinfectant manufacturer. Never sterilize or
autoclave the sensors.
2-8
Maintenance
Clean the temperature sensor after each use. To clean the temperature sensor:
1. Hold the probe with one hand and clean the sensor from the top with a wet
lint- free cloth dampened with isopropanol.
2. In addition, regularly disinfect the sensor with ethylene oxide.
3. Use a dry cloth to clean the surface of the temperature sensor.
4. Check the temperature sensor and do not use it if you see any signs of
damage or deterioration.
Caution Never heat the sensor to over 100°C (212°F). Only heat it to 80°C (176°F) - 100°C (212°F)
for a short time.
After extended use, deposits of paper debris may collect on the print head making
recordings uneven and faint, shortening the life of the print head and the roll shaft.
2-9
Maintenance
To avoid long-term damage to cables, do not disinfect a cable unless directed by the
hospital. Always shut off the monitor and clean it before performing any
disinfection.
Do not use strong solvents for disinfection. Always dilute cleaning agents according
to the manufacturer’s instructions or use the lowest possible concentration. Disinfect
the equipment with a cloth moistened with these materials.
– 70% ethanol, 70% isopropyl alcohol
– Acetaldehyde: Cidex
Caution When disinfecting any accessories, follow the manufacturer’s instructions; otherwise, use
the disinfection agents listed in this chapter.
2-10
Maintenance
2-11
Maintenance
2-12
Maintenance
1. Connect power cable between the wall outlet and monitor power connector and
power the monitor up.
2. Check if the power indicator lights up and the indicator color.
3. Green: The monitor is powered on and in normal working status.
4. Yellow: The monitor is connected to AC power but not turned on. It is under
internal battery charging status.
5. Press the stand-by key of the monitor to turn on the monitor and unplug the power
cable. Inspect if the power indicator is green and if a battery mark displaying in
the status box on the screen, showing that the monitor is powered by batteries.
2-13
Maintenance
2-14
Maintenance
1. Connect an adult SpO2 transducer that you know to be working correctly to the
SpO2 connector on the monitor. Ensure that the red LED in the sensor in the
transducer is lit.
2. Connect the other end of the transducer to your finger (this assumes that you are
healthy).
3. Verify that the SpO2 value displayed on the monitor is between 95% and 100%. If
it is not, try the test again with a patient simulator.
Before you start, see Required Test Equipment for a list of the equipment that you
need to perform this test.
These tests check the performance of the non-invasive blood pressure measurement.
Perform each of these NIBP checks and procedures when checking the NIBP unit:
• NIBP accuracy
• NIBP calibration procedure (if required)
• NIBP overpressure valve
2-15
Maintenance
3. Press the Main menu key, the Main Menu window appears. Rotate the wheel to the
System button, press the wheel.
4. Rotate the wheel to the System Maintenance ..., enter this menu.
5. Rotate the wheel to the Pressure Test, press the wheel to start test.
6. Squeeze the manometer pump and apply a pressure of 50mmHg.
7. Note the pressure displayed in the NIBP Test window and record this result as X1
(see Test Recording). It should be 50mmHg +/- 3mmHg.
8. Squeeze the manometer pump to apply a pressure of 250mmHg to the monitor.
9. Note the pressure displayed in the NIBP Test window and record this result as X2.
The pressure in the NIBP Test window should be 250mmHg +/- 3mmHg.
10. Press the NIBP button to stop the test.
11. If the difference between the manometer and displayed values is greater than
3mmHg, calculate the difference by the following formula, and then calibrate the
monitor.
Vadj = [(X1 – 50) + (X2 – 250)] / 2
Note: You need to round up the result.
12. If the difference between the manometer and displayed values is not greater than
3mmHg, skip to the “To Test the Overpressure”.
2-16
Maintenance
1. Turn on alarm sound and set Heart Rate alarm limits. Test if the monitor would
make alarm sound when heart rate is out of the alarm limits.
2. Silence alarm sound and test if the monitor will make alarm sound when heart rate
is out of the alarm limits.
3. Turn on the alarm sound. Speaker test is complete.
After monitor is networked with the UT 4800 Central Monitoring System, inspect if the
ECG waveform and its parameters are correctly displayed at the Central Monitoring
System display.
2-17
Maintenance
Electrical safety test inspects whether the monitor has potential hazards to patients or
operators.
In order to establish a systematic maintenance plan, we recommend all safety tests and
records shall be made under the following circumstances: every year, and the monitor
is opened for repair.
Use the following safety test procedures for verifying safe installation or service of the
monitor. The setups used for these tests and the acceptable ranges of values are derived
from local and international standards but may not be equivalent. These tests are not a
substitute for local safety testing where it is required for an installation or a service
event. If using the Metron Safety tester, perform the tests in accordance with your local
regulations, for example in Europe use IEC60601-1/IEC60601-1-1. The Metron Report
should print results with the names listed below, together with other data.
2-18
Maintenance
S(1) Part 2: System Enclosure Leakage current - Single Fault (open earth)
2-19
Maintenance
2-20
Troubleshooting
Chapter 3 Troubleshooting
This chapter describes how to troubleshoot monitor problems. After using
this chapter to diagnose a problem, see Chapter 5(G40) or Chapter 6(G30)
to repair the monitor or to remove and replace a part or assembly.
3-1
Troubleshooting
3-2
Troubleshooting
3-3
Troubleshooting
Measure the good battery’s Measure the good battery’s voltage and
voltage and record; then replace record; then replace the battery.
the battery.
Is the
voltage of T2/T3 the same
as the good battery’s Can the monitor be powered on?
Yes No Yes No
3-4
Troubleshooting
Check AC
Figure
Power cable
3-6
and fuse
Is there
Yes a voltage about
15V?
No
Replace main
Measure voltage of AC/
module
DC module’s input
assembly
Is the AC voltage
Yes the same as the
Supply mains?
No
Replace
Replace
AC power
AC/DC module
assembly
3-5
Troubleshooting
Is there
Yes a tone or any sound No
from the fan?
Yes
Replace
Replace Main Board Fix it
battery board
assembly
3-6
Troubleshooting
3-7
Troubleshooting
4-8
Troubleshooting
Power is on, but the monitor There is a bad connection with Ensure that there is a proper
the backlight LCD connection between the cable,
screen is Blank LCD, backlight and Main board
module.
There is a bad LCD. Replace the Display assembly.
See “To remove the Display
assembly” in Chapter 5 (G40) or
Chapter 6 (G30).
There is a bad inverter. Replace the inverter. See “To
remove the Inverter” in Chapter
5 (G40) or Chapter 6 (G30).
The Main board module has Replace the Main board module.
malfunctioned. See “To remove the Main board
module” in Chapter 5 (G40) or
Chapter 6 (G30).
The monitor displays random/ The LCD cable is not attached Open the monitor and reseat the
correctly LCD signal cable. See “Front
distorted graphics with a white Case Disassembly Procedures”
in Chapter 5 (G40) or Chapter 6
background. (G30).
The LCD is bad Replace the Display assembly.
See “To remove the Display
assembly” in Chapter 5 (G40) or
Chapter 6 (G30).
The Main board module has Replace the Main board module.
malfunctioned. See “To remove the Main board
module” in Chapter 5 (G40) or
Chapter 6 (G30).
I turn on the monitor and the The ARM module has Replace the ARM MODULE.
malfunctioned. See “To remove the ARM
opening screen and/or color bar module” in Chapter 5 (G40) or
Chapter 6 (G30).
starts, but then just hangs.
The monitor does not respond to There is a bad connection to the Ensure that all connectors to the
Main board module. Main board module are seated
the navigation wheel or front correctly.
The monitor keypad or Replace the front case, See
panel buttons
navigation wheel is broken. “Front Case Disassembly
Procedures” in Chapter 5 (G40)
or Chapter 6 (G30).
The Main board module has Replace the Main board module.
malfunctioned. See “To remove the Main board
module” in Chapter 5 (G40) or
Chapter 6 (G30).
4-9
Troubleshooting
Audible alarms do not sound There is a bad connection to the Ensure that the connection to
speaker. speaker is correct.
The speaker is bad. Replace the speaker. See “Rear
case disassembly procedure” in
Chapter 5 (G40) or Chapter 6
(G30).
The Main board module has Replace the Main board module.
malfunctioned. See “To remove the Main board
module” in Chapter 5 (G40) or
Chapter 6 (G30).
The NIBP cuff does not inflate The tube or cuff is kinked. Straighten the tube or cuff.
There is an air leak in the air Replace the cuff and ensure that
tube or cuff. there is no air leakage in the
tube.
The NIBP module has Replace the NIBP pump
malfunctioned. module. See “To remove the
NIBP Module” in Chapter 5
(G40) or Chapter 6 (G30).
There are no NIBP readings Wrong cuff size or incorrect cuff Use proper cuff size, ensure
placement. proper cuff placement.
The tube is kinked or there is air Ensure that the tube is straight
leakage in the air tube or cuff. and not kinked. Replace the cuff
and ensure that there is no air
leakage in tube.
There has been some external Ensure that all external blood
problem. pressure reading requirements
are met and that the patient is not
moving excessively.
There is an NIBP module error. Replace the NIBP pump
module. See “To remove the
NIBP Module” in Chapter 5
(G40) or Chapter 6 (G30).
The ARM module has Replace the ARM module. See
malfunctioned. “To remove the ARM module”
in Chapter 5 (G40) or Chapter 6
(G30).
I’m getting unreliable NIBP Wrong cuff size or incorrect cuff Use proper cuff size, ensure
placement. proper cuff placement.
readings There have been some external Ensure that all external blood
problems. pressure reading requirements
are met and that the patient is not
moving excessively.
4-10
Troubleshooting
There are no temperature The probe lead is off. Ensure that the temperature
probe is connected.
readings The temperature is over range. Ensure that temperature readings
are in the range of 15oC-45oC.
The probe has malfunctioned. Replace the temperature probe.
The IBP and TEMP module Replace the IBP and TEMP
board has malfunctioned. board. See “To remove the IBP
and TEMP module” in Chapter 5
(G40) or Chapter 6 (G30).
I’m getting unreliable The probe has malfunctioned. Replace the temperature probe.
The IBP and TEMP module Replace the IBP and TEMP
temperature readings board has malfunctioned. Module board. See “To remove
the IBP and TEMP module” in
Chapter 5 (G40) or Chapter 6
(G30).
There are no SpO2 readings The SpO2 sensor has Replace the SpO2 sensor.
malfunctioned.
The SpO2 board has Replace the SpO2 board. See “To
malfunctioned. remove the SpO2 Board” in
Chapter 5 (G40) or Chapter 6
(G30).
The ARM module has Replace the ARM MODULE.
malfunctioned. See “To remove the ARM
module” in Chapter 5 (G40) or
Chapter 6 (G30).
The SpO2 readings are There has been some external Ensure that all external SpO2
problem. reading requirements are met
unreliable and that the patient is not
moving excessively.
There are no CO2 The CO2 module is initializing. Wait until initialization is
complete.
readings The CO2 tube is kinked. Check the tube to ensure that it
is straight.
The CO2 module has Replace the CO2 module. See
malfunctioned. “Remove the CO2 module” in
Chapter 5 (G40) or Chapter 6
(G30).
The ARM module has Replace the ARM module. See
malfunctioned. “To remove the ARM module”
in Chapter 5 (G40) or Chapter 6
(G30).
4-11
Troubleshooting
The CO2 readings area The CO2 tube is kinked. Check the tube and make sure
that it is straight.
unreliable There have been some external Ensure that all external CO2
problems. reading requirements are met
and that the patient is not
moving excessively.
There are no ECG readings The ECG leads are off. Ensure that the leads are
connected.
The ECG cable is broken. Ensure that the cable is in good
working order.
The ECG 3/5 lead set is not Correct the ECG
configured correctly. configuration.
The ARM module has Replace the ARM module. See
malfunctioned. “To remove the ARM module”
in Chapter 5 (G40) or Chapter 6
(G30).
The ECG module has Replace the ECG board. See
malfunctioned. “Remove ECG board” in
Chapter 5 (G40) or Chapter 6
(G30).
I’m getting unreliable ECG The ECG leads are off. Ensure that the ECG leads are
connected.
readings There has been some external Ensure that all external ECG
problem. reading requirements are met
and that the patient is not
moving excessively. Ensure
proper skin preparation has been
performed.
There are no respiration The respiration leads are off. Ensure that the respiration leads
are connected.
readings The ECG module has Replace the ECG board. See
malfunctioned. “Remove ECG board” in
Chapter 5 (G40) or Chapter 6
(G30).
The respiration readings are There has been some external Ensure that all respiration
interference. reading requirements are met
unreliable and that the patient is not
moving excessively. Ensure that
the correct ECG lead set is being
used.
4-12
Troubleshooting
The recorder paper is The paper is not installed Remove paper and reinstall
correctly. correctly.
jamming The recorder is using improper Use only the recommend
paper. recorder paper.
The recorder has a mechanical Replace the recorder module.
problem. See “To remove the recorder” in
Chapter 5 (G40) or Chapter 6
(G30).
The recorder does not print The paper is out and/or the Install a new paper supply. Open
recorder door is open. the recorder door, and then close
it again.
The system does not recognize Check the recorder’s physical
the recorder. connections. See “To remove the
recorder” in Chapter 5 (G40) or
Chapter 6 (G30).
The recorder module has Replace the recorder module.
malfunctioned. See “To remove the recorder”
in Chapter 5 (G40) or Chapter
6 (G30).
The ARM module has Replace the ARM module. See
malfunctioned. “To remove ARM module” in
Chapter 5 (G40) or Chapter 6
(G30).
4-13
Troubleshooting
4-14
Theory of operation
4-1
Theory of operation
Ethernet port
Display output USB Port ECG analog
(RJ45 Nurse call port
port Only for update output port
connector)
ARM Module
Batteries
Main Board assembly
Keys
AC/DC power
module Speaker Driver
Charge control Navigation
AC power Inverter control wheel
assembly Keys control Front case
AC socket Power supply to other modules assembly
Signals interface Battery LED
Supply mains
Power LED
4-2
Theory of operation
This chapter contains a high-level overview of the theory of operation of some major
functional components of the G30/G40 Patient Monitors.
This chapter contains a system overview for the G30/G40 Patient Monitors,
including a high-level block diagram. This block diagram shows major components
of the monitor, including the power supply, NIBP control, SpO2 and CO2 processing,
and microcontroller. The monitor is a full function monitor for use on adult, pediatric,
and neonatal patients. The functions performed by the system include:
• Monitoring patient ECG, heart rate and respiration rate
• Blood pressure
• Blood oxygen saturation
• Carbon dioxide
• Temperature
The G30/G40 Patient Monitors operate from either an AC power source or battery
power. The monitor charges the battery when powered by AC.
4-3
Theory of operation
The system board contains a DC/DC voltage converter, which provides power and
communication to:
• IBP
• ECG
• SpO2
• NIBP
• IBP/Temp
• CO2
• Recorder
• ARM board
• Inverter
• AC/DC power module
• Speaker
• Keys
• Battery charging module
The output interface board provides the connector socket for the following
applications:
• Display output port
• Nurse call port
• USB Port
• Ethernet port
• ECG analog output port
4-4
Theory of operation
4.2.6 Speaker
The speaker is driven by an amplifier. The speaker provides the monitor’s audio
during alarm conditions. The microprocessor outputs different audio tones specified
by different alarm priorities and conditions.
4.2.7 Recorder
The G30/G40 Patient Monitors contain a medical grade power supply module and
circuitry that converts AC (100-240V) to DC (15V). Power consumption is 115 VA.
The keys and navigation wheel generate pulses to the Main Board assembly during
use, and the Main Board assembly encodes the message to the ARM module, so the
patient monitor can respond to all kinds of operations.
Pressure data is converted to digital format and conveyed to the processor. The NIBP
pump uses an oscillometric method that employs stepwise pressure deflation. Pump
software eliminates most ambient noise and motion interference. Applications are
neonatal, pediatric and adult patients. The blood pressure range is: Systolic, 30-254
mmHg and Diastolic, 10-220 mmHg. Accuracy is Maximum Mean Error ±5 mmHg
4-5
Theory of operation
The monitor measures the patient's ECG signals by sensing the varying potential
difference between several points at the skin surface which respond to the
electro-chemical actions of the muscular activity of the heart. Up to five electrodes
are attached to the patient’s body. The varying potentials at these locations are sent
to the ECG circuitry. These signals are amplified and filtered and then digitized
before being transmitted to the microprocessor.
The microprocessor executes algorithms to:
• Calculate the ECG data
4-6
Theory of operation
Note — The ECG analog output is available at a connector on the back of the monitor.
The invasive blood pressure (IBP) measurement produces real-time waveforms and
numeric values for systolic, diastolic, and mean arterial blood pressure. IBP
measurements use an A/D converter. An isolation transformer and opto-coupler
provide the required isolation between isolated and grounded chapters of the monitor.
Software algorithms filter typical artifacts like respiratory variation and pressure
changes caused by flushing the line or drawing blood samples.
4.2.15 etCO2
The G30/G40 Patient Monitors use the Microstream® sidestream etCO2 method to
measure carbon dioxide (CO2). The sidestream measurement method samples the
respiratory gas with a constant flow from the patient’s airway and analyzes it with a
4-7
Theory of operation
All infrared gas measuring instruments, including the CO2 module, consist of a
radiation source, a cell through which samples of gas flow and a detector that
transmits a signal related to the intensity of the radiation that is detected. The
quantitative aspects of photometric measurement are stated by the Beer-Lambert
law:
A = Log (Io/I) = εlc
Under carefully controlled conditions at a select absorption band, the absorbency of a
sample (A) is proportional both to the concentration of the sample (c) and the depth
of the absorbing layer (l). The molar extinction coefficient (ε) is a wavelength
dependent constant characterizing the sample. (Io) is the light intensity at zero
absorbency and (I) is the light intensity after some of the light is absorbed by the
sample. The CO2 module, as most continuous monitors of carbon dioxide, uses a non
dispersive infrared (NDIR) light source. All CO2 monitoring instruments, except
those manufactured by Oridion, that use a NDIR infrared light source, use the broad
band energy from a black-body source. A mechanical chopper modulates the light
beam and makes possible the monitoring of the sample, reference and dark signals
from which the concentration of carbon dioxide can be determined. The CO2 module
uses the energy generated by an infrared source that includes a proprietary gas filled
lamp and driver circuit. This energy contains only specific wavelengths which match
the absorption bands of the CO2. The CO2 module's infrared source is electronically
modulated by the driver circuit.
The G30/G40 Patient Monitors contain a medical grade power supply module and
circuitry that converts AC (100-240V) to DC (15V). Power consumption is 115 VA.
4-8
Theory of operation
• DC/DC converter
The power management circuitry charges the battery through a battery charger(s).
Both the battery(s) and the AC/DC power module can power the system through
several DC/DC converters that provide various voltage outputs required by various
chips. Isolated transformers provide the power to the front ends floating area.
The nurse call alarm contacts are available through a 3.5mm, miniature insulated
phone jack on the back of the unit. The alarm contacts close (open) for any alarm
condition detected by the monitor.
The alarm contacts are the three switching signals associated with a single pole,
double throw relay. These are the:
• Normally open contact (NO)
• Common contact
• Normally closed contact (NC)
4-9
Theory of operation
(Blank)
4-10
G40 System Disassembly
5-1
G40 System Disassembly
Caution Before removing the battery, perform a monitor shutdown and remove from AC
power.
2. One thumb pushing the batteries and the other rotating the battery holder, to let the
batteries out.
5-2
G40 System Disassembly
2. Replace the fuse as the showing. Then push the fuse holder back into the power
connector until it snaps into place.
5-3
G40 System Disassembly
2. Remove the two M3×6 screws holding the recorder to the monitor case.
3. Place your two thumbs on either side of the recorder case and pull it straight out of
the assembly and remove the recorder connector cable.
5-4
G40 System Disassembly
2. Remove two M4×12 screws, then turn the monitor upright, the front case and the
rear case are held by the buckle, gently open the monitor.
5-5
G40 System Disassembly
5-6
G40 System Disassembly
5-7
G40 System Disassembly
4. Remove the two M3 nuts by hexagon nut driver Φ5.5mm, and then remove the
inverter.
5-8
G40 System Disassembly
5-9
G40 System Disassembly
5-10
G40 System Disassembly
5-11
G40 System Disassembly
5-12
G40 System Disassembly
3. Set the socket into the connector panel, and rotate it as showing direction 90°.
5-13
G40 System Disassembly
2. Remove the connector cables carefully, and then remove the NIBP module gently.
5-14
G40 System Disassembly
5-15
G40 System Disassembly
2. Unplug the cable, cut the cable tie, and remove the yellow-green wire.
5-16
G40 System Disassembly
5-17
G40 System Disassembly
3. Remove the speaker’s M3×6 screws then remove the speaker gently.
5-18
G30 System Disassembly
6-1
G30 System Disassembly
6-2
G30 System Disassembly
2. Replace the fuse, remove the fuse as shown. Then push the fuse holder back into
the power connector until it snaps into place.
6-3
G30 System Disassembly
2. Remove the two M3×6 screws holding the recorder to the monitor case.
3. Place your two thumbs on either side of the recorder case and pull it straight out
assembly and remove the recorder connector cable gently.
2. Remove the two M4×8 screws, then turn the monitor upright, the front case and
the rear case are held by the buckle, gently open the monitor, and disconnect the
6-4
G30 System Disassembly
cables as shown.
6-5
G30 System Disassembly
2. Pull out the inverter control cable and the LCD driver cable.
6-6
G30 System Disassembly
3. Remove the two M2×4 screws, and then remove the inverter.
2. Turn the monitor over, remove the three M4×6 screws, and then pull the main
frame out gently.
6-7
G30 System Disassembly
6-8
G30 System Disassembly
6-9
G30 System Disassembly
3. Set the socket into the connector panel, and rotate it as showing direction 90°.
6-10
G30 System Disassembly
6-11
G30 System Disassembly
6-12
G30 System Disassembly
6-13
G30 System Disassembly
6-14
G30 System Disassembly
6-15
G30 System Disassembly
6-16
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7-18
Appendix A Electromagnetic Compatibility
A-1
A.1 Instructions for use
Warning Use of accessories, transducers, and cables other than those specified may
result in increased emissions and/or decreased immunity of the G30/G40
Patient monitors.
G30/G40 Patient monitors should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the monitor should
be observed to verify normal operation in the configuration in which it is
used.
A-2
A.2 Guidance and Manufacturer's EMC Declaration
The G30/G40 Patient Monitors are intended for use in the electromagnetic environment
specified below. The customer or the user of the G30/G40 Patient Monitors should assure
that it is used in such an environment.
Electrical fast ±2 kV for power ±1kV for Mains power quality should be
transient/burst supply lines power supply that of a typical commercial or
IEC 61000-4-4 lines hospital environment. It
recommends the use of filters on
power input lines.
A-3
IEC 60601 test Compliance Electromagnetic environment -
Immunity test
level level guidance
Surge ±1 kV ±1 kV Mains power quality should be
IEC 61000-4-5 Differential differential mode that of a typical commercial or
mode ±2 kV hospital environment.
±2 kV common common mode
mode
Voltage dips, <5% UT1 <5% UT Mains power quality should be
short (>95% dip in UT) (>95% dip in UT) that of a typical commercial or
interruptions and for 0.5 cycle for 0.5 cycle hospital environment. If the user
voltage variations of the G30/G40 Patient Monitors
on power supply 40% UT 40% UT requires continued operation
input lines (60% dip in UT) (60% dip in during power mains
IEC 61000-4-11 for 5 cycles UT)for 5 cycles interruptions. It is recommended
that the G30/G40 Patient
70% UT 70% UT Monitors be powered from an
(30% dip in UT) (30% dip in UT) uninterruptible power supply or a
for 25 cycles for 25 cycles battery.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency magnetic fields
(50/60Hz) Should be at levels characteristic
magnetic field of a typical location in a typical
IEC61000-4-8 commercial or hospital
environment.
1. UT is the AC mains voltage prior to application of the test level.
A-4
A.2.3 Electromagnetic Immunity for Equipment and Systems not
Life-Supporting
Table A-3 Electromagnetic immunity –for Equipment and Systems not Life-Supporting
⎡7⎤
d =⎢ ⎥ P
⎣ E1 ⎦
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
A-5
strength in the location in which the G30/G40 Patient Monitors are used exceeds the applicable
RF compliance level above, the G30/G40 Patient Monitors should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the G30/G40 Patient Monitors.
2. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The G30/G40 Patient Monitors are intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the G30/G40 Patient
Monitors can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the G30/G40
Patient Monitors as recommended below, according to the maximum output power of the
communications equipment.
Table A-4 Recommended separation distances between portable and mobile RF communications
equipment and G30/G40 Patient Monitors
Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
output power of
⎡ 3 .5 ⎤ ⎡ 3 .5 ⎤ ⎡7⎤
transmitter d =⎢ ⎥ P d =⎢ ⎥ P d =⎢ ⎥ P
(W) ⎣ V1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
1. For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Note — At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies. These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
A-6
The following interference test results do not affect patient diagnoses.
A-7
(Blank)
A-8