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CTG7 SG Eng 3.0 PDF
CTG7 SG Eng 3.0 PDF
Fetal/Maternal Monitor
Service Guide
English
CTG7
Fetal/Maternal Monitor
Service Guide
English
Product Information
Product models: CTG7
Product name: Fetal/Maternal monitor
Standard
The product is made under the ISO9001and ISO13485 quality system certified by TUVPS.
Manufacturer
Shenzhen Goldway Industrial Inc.
Registered/Production Address:
Edition
Third Edition: September 2012
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.
Declaration
The CTG7 Fetal/Maternal monitor is a Class IIb device and complies with the requirements of the Council
Directive 93/42/EEC concerning medical devices and carries CE-marking accordingly.
Authorized EU Representative
Shanghai International Holding Corp.GmbH (Europe)
Eiffestrasse 80, 20537
Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
Goldway is responsible for the safety, reliability and performance of the monitor when the:
Safety Standards
Table 2 Safety Standards
Parameter Specification
Protection Class Class I, anti-shock, externally and internally powered equipment, per IEC
60601-1
Safety Requirements
Note — The safety indications in this chapter apply to general monitor use. Safety indications in other
chapters apply to specific monitor measurements. Follow the instructions in this user manual when using the
monitor. However, conventional medical practices always supersede this document. Significance of safety
requirements set forth here in this manual is not in order of reading sequence.
Ensure that the patient monitor is in good working condition and is placed in the proper position before
clinical use.
Never use cables that have exposed conductors on both ends. Only use undamaged cables and
connectors and check them before using.
Never simultaneously touch the patient and the input or output terminal of the monitor.
The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, CT scans or
MRI.
Never use the monitor on patients with pacemakers or the patient has an arrhythmia problem.
The fetal/maternal monitors are NOT intended for use for ECG measurements on patients connected to
external electrical stimulators or with cardiac pacemakers.
Disconnect the AC power supply and remove the battery before disassembling the monitor.
Never rely exclusively on the alarm system for patient monitoring. Low alarm limits or turning the
alarm off during patient monitoring may result in patient danger. The most reliable method of patient
monitoring combines close, personal surveillance along with the correct operation of the monitor. You
must periodically check that monitor alarms are working properly.
Caution Only use the monitor in environments as specified in Table B-10 in Chapter B, “Specifications” of the
CTG7 Fetal/Maternal Instructions for Use. Otherwise, damage to the monitor can occur.
To avoid personal injury, only use accessories and parts produced or recommended by Goldway.
Otherwise, damage to the monitor can occur.
Position power cords and other accessory cables to prevent tangling, patient contact, or electrical
interference.
Always properly ground the monitor. Use the monitor on battery power only if you suspect any
problem with external grounding or wiring.
If multiple devices are connected to a patient, the sum of the leakage currents may cause a dangerous
situation. Therefore, qualified service representatives should always perform current leakage tests
before setting up the connections. This ensures that leakage is within limits and prevents personal injury
and environmental damage. Contact Goldway for correct usage.
The monitor must conform with the international standard IEC 60601-1-2 and other applicable EMC
standards. Interference takes place when electromagnetic energy is extremely high. Ensure that any
nearby instruments are also in compliance with EMC standards. Never turn on or use portale.
Any devices connected to the monitor must comply with the IEC standard for that device. For example,
data processing devices must comply with IEC 60950 and medical devices must conform to IEC 60601-1.
The whole system must comply with the most recent IEC 60601-1-1 standards.
To ensure monitor safety, all service parts and accessories must comply with IEC 60601 standards. The
system configuration of the monitor must comply with IEC 60601-1-1 medical electrical standards.
User configurations will be saved automatically when the monitor is powered off.
Ensure that qualified service representatives annually calibrate and maintain the monitor.
Periodically check all reusable accessories for damage. Replace and dispose of damaged accessories and
monitors according to your local hospital waste disposal regulations.
ECG electrodes are disposable accessories. Always properly dispose of ECG electrodes according to
your local hospital waste disposal regulations.
Clean and sterilize the monitor and accessories according to local requirements. Turn off the monitor
and disconnect the power cords before cleaning or sterilization.
Keep all monitor packing materials away from children, or dispose of them in accordance with your local
environmental regulations.
Always properly dispose of the monitor and all accessories at the end of their service life. Dispose of
batteries according to your local regulations. Never incinerate batteries or expose them to high
temperatures.
Ensure that no water condenses into or on the monitor. Condensation can occur from changes in
temperature or exposure to humidity.
4 Troubleshooting
4.1 Power Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Display Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.3 Alarm Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.4 Fetal Monitoring Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.5 NIBP Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.6 SpO2 Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.7 ECG Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.8 Recorder Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.9 Performance Verification Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
7 Electromagnetic Compatibility
7.1 Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Guidance and Manufacturer's EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2.1 Electromagnetic Emissions for all Equipment and Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2.2 Electromagnetic Immunity for all Equipment and Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.2.4 Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Environmental Specifications
Temperature Range Operating 10oC - 40oC (50oF - 104oF)
Maximum operating time At least 4 hours with continuous FHR and TOCO
monitoring
Discharge protection On battery power, the monitor powers off when the
battery is depleted.
Feature Standard/Optional
TOCO monitoring ●
Maternal ECG1 o
Event marker ●
Waker device o
1. Maternal ECG cannot be ordered without the maternal NIBP and SpO2 options.
2. Maternal NIBP and SpO2 options must be ordered together.
2. Attach the metal mounting bracket to the bottom of the adapter plate.
Caution The frequencies specified in the following table do not supersede local requirements. Always perform both
locally required testing and the testing outlined in the table.
Tests Frequency
Preventive Maintenance
Performance
• System Enclosure Leakage Current Once every 12 months, and after repairs where the unit
has been opened (front and back separated) or the
• Ground Integrity
monitor has been damaged by impact.
• Patient Leakage Current With Mains
Voltage
Test Equipment
“Visual Test” on page 2-4 None
“Fetal Monitoring Test” on page 2-4 Fetal simulator & Fetal monitoring probe
Test Equipment
“ECG Performance” on page 2-7 ECG simulator & ECG patient cable
“NIBP Test” on page 2-4 A reference manometer (includes hand pump and valve).
Accuracy 0.2% of reading.
An expansion chamber (volume 500 ml ±10%)
A piece of appropriate tubing
1. P = pass
2. F = fail
3. X = measured value as defined in test in this chapter.
This test checks the accuracy of the NIBP measurement. To test for NIBP accuracy:
1. Connect the manometer and the NIBP connector on the CTG7 Fetal/Maternal monitor with tubing.
NIBP screen
8. Press the NIBP key on the front panel of the monitor. Note the pressure displayed in the NIBP numeric
pane and record this result as X1 (see Table 2-4 on page 2-3). The reading should be 50mmHg
±3mmHg.
9. Press the NIBP key to stop the test.
10. Squeeze the manometer pump and apply a pressure of 250mmHg.
11. Press the NIBP key on the front of the monitor. Note the pressure displayed in the NIBP Numeric Pane
and record the result as X2. 250 mmHg ± 3mmHg is a proper result.
12. Press the NIBP key on the front of the monitor to stop the test.
13. If the difference between the manometer and displayed values is greater than 3mmHg, calculate the
difference using the following formula, and then calibrate the monitor (see section "NIBP Calibration").
Vadj = [(X1 - 50) + (X2 - 250)] / 2
14. If the difference between the manometer and displayed values is not greater than 3mmHg, see section
"Overpressure Test".
The NIBP leakage test checks the integrity of the system and of the valve. Perform this test once every two
years as well as when you repair the monitor or replace parts.
1. After you calibrated the NIBP, repeat steps 3~6 of the accuracy test.
2. Squeeze the manometer pump and apply a pressure of 250mmHg.
3. Wait a few seconds for the measurement to stabilize.
4. Watch the pressure value for 60 seconds.
5. Calculate and document the leakage test value (X3).
X3= P1-P2
where P1 is the pressure at the beginning of the leakage test and P2 is the pressure displayed after 60
seconds.
The leakage test value should be less than 6 mmHg.
Note — Safety tests meet the standards of, and are performed in accordance with IEC 60601-1, Clause 19
(EN60601-1:1990). The CTG7 Fetal/Maternal monitors have been classified as Class IIb equipment. They are
double insulated and do not require a protective earth (ground) wire.
Figure 2-3 S (1) Part 1: System Enclosure Leakage Current - NC (Normal Conditions)
Excepted Test Results:
Normal condition maximum leakage current X1≤ 500μA.
This measures leakage current of exposed metal parts of Instrument under Test (IUT) and between parts of the
system within the patient environment; normal and reversed polarity using S2.
Safety test according IEC 60601-1 / UL2601-1
Figure 2-4 System Enclosure Leakage current - Single Fault (open earth)
Expected Test Results:
Single Fault maximum leakage current x2 ≤ 100μA (IEC 60601-1)
≤ 500μA (UL2601-1)
This measures leakage current of exposed metal parts of Instrument under Test (IUT) with Protective Earth
(PE) open circuit (S4 = open) and between parts of the system within the patient environment; normal and
reversed polarity using S2.
2.7.3 S(1): Sum of Functional Earth and Enclosure Leakage Current Test
Figure 2-6 Patient Leakage Current - Single Fault Condition (S.F.C) Mains on Applied Part
Expected Test Results:
Maximum leakage current, x = 50μA@250V (IEC 60601-1 and UL2601-1).
This measures leakage current of exposed metal parts of Instrument under Test (IUT) with Protective Earth
(PE) open circuit (S4=open) and between parts of the system within the patient environment; normal and
reversed polarity using S2.
Caution Use of ultrasound gel that is not approved by regulations (CE certificate) may reduce signal quality and may
damage the transducer. This type of damage is not covered by warranty.
If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the
tests, confirming that the first transducer is defective, contact an authorized service agent. If the second
transducer also fails the tests, contact Goldway’s Customer Service Department.
Note — The new software will be released by Goldway with Goldway’s Field Change Order (FCO).
5. Select the corresponding CD-ROM drive and select CH340. Cilick OK.
Note — If the messages do not display as in Figure 2-18, press Enter to refresh.
Note — If an error message appears or the transfer is interrupted, retry until the file sends successfully.
6. After the file is successfully sent, “done” appears in Hyper Terminal window.
4. Type the id number of the language which you want to install. The following shows an example of
setting the CTG7 for Englis (2).
The monitor does not The power cord is Ensure that the AC power cord is plugged into
turn on with AC power. unplugged. an outlet.
The power LED does
not light and the screen The power cord is broken.
is blank.
The power supply Check the output voltage on the power supply.
malfunctioned. If it does not measure 15 V, replace the power
supply. See "Removing the AC/DC Power
Module" on page 5-27.
Poor contact between the Fix the connector cable between the system
system module and power board and power supply module.
supply module.
The keypad board Replace the keypad board. See "Removing the
malfunctioned. Navigation Wheel Board" on page 5-14.
The system board Replace the system board. See "Removing the
malfunctioned. System Board" on page 5-23.
The monitor turns on The battery or connector Reseat both the battery and battery cable. See
with AC power, but cable is loose. "Removing/Replacing the Battery" on page 5-1.
does not with battery The battery has run out of Charge the battery. If after 48 hours of
power. power. charging, there is still no battery power, the
battery is damaged.
The system board Replace the system board. See "Removing the
malfunctioned. System Board" on page 5-23.
The display board module Replace the system module. See "Removing the
malfunctioned. System Board" on page 5-23.
The monitor displays The LCD cable is not Open the monitor and reseat the LCD signal
random/ distorted attached correctly. cable.
graphics with a white
background. The LCD malfunctioned. Replace the Display assembly. See "Removing
the LCD Display Assembly" on page 5-15.
The display board module Replace the system module. See "Removing the
malfunctioned. System Board" on page 5-23.
The monitor does not There is a bad connection Ensure that all connector cables from the keypad
respond to the of the keypad board, board to the system module are seated correctly.
navigation wheel or printing board and system
front panel buttons. board.
The monitor keypad or Replace the front case. See "Removing the
navigation wheel is Navigation Wheel Board" on page 5-14 and
broken. "Removing the Navigation Wheel Board" on
page 5-14.
The monitor display is • Poor contact between • Ensure that the LCD screen cable is well
blank or displays the LCD screen and connected to the LCD display board module.
random or distorted LCD display board • Replace the LCD screen.
module.
graphics. • Replace the LCD display board module.
• LCD screen failure.
• The LCD display board
module malfunctioned.
There is a bad connection Ensure that all connectors to the system module
to the system module. are seated correctly.
There is poor contact between Restart the monitor, if the problem remains:
the fetal monitoring module – Replace the fetal monitoring module.
and the system module. – Replace the system module.
The fetal monitoring module After replacing the fetal monitoring module
malfunctioned. and the system module, if the problem still
The system module exists, contact Goldway.
malfunctioned.
There is no TOCO data There is poor contact of the US Ensure that the transducer is connected to the
after the TOCO transducer. monitor.
transducer is The TOCO transducer Replace the TOCO transducer.
connected. malfunctioned.
The FHR waveform is The US transducer is applied Apply ultrasound transmitter gel to the
too faint to be incorrectly. transducer.
observed. Adjust the transducer on the mother's
abdomen.
There is a leak in the air tube or Replace the cuff and ensure that there is no air
cuff. leakage in the tube.
The NIBP module malfunctioned. Replace the NIBP module. See "Removing the
NIBP Module" on page 5-24.
The NIBP pump filter is blocked. Replace the NIBP module. See "Removing the
NIBP Module" on page 5-24.
The system board malfunctioned. Replace the system board. See "Removing the
System Board" on page 5-23.
NIBP • Wrong cuff size. Use proper cuff size, ensure proper cuff
measurements • Incorrect cuff placement. placement.
are not
displayed. • The tube is kinked. • Ensure that the tube is straight and not kinked.
• There is a leak in the air tube • Replace the cuff and ensure that there is no
or cuff. leak in the tube.
• There is a leak in the NIBP • Replace the NIBP connector.
socket.
External problems exist. • Ensure that all external blood pressure reading
requirements are met.
• Ensure that the patient is not moving
excessively.
The NIBP module malfunctioned. Replace the NIBP module. See "Removing the
NIBP Module" on page 5-24.
The I/O board malfunctioned Replace the I/O board. See "Removing the
Battery Charger Board" on page 5-29.
The system module Replace the system module. See "Removing the
malfunctioned. System Board" on page 5-23.
NIBP Wrong cuff size or incorrect cuff Use proper cuff size and ensure proper cuff
measurements placement. placement.
are unreliable. The initial pressure setting is Specify the correct intial pressure.
incorrect.
A problem external to the monitor Ensure all external blood pressure reading
occurred. requirements are met and that the patient is not
moving excessively.
The NIBP module needs to be Recalibrate the NIBP module. See "NIBP
calibrated. Calibration" on page 2-6.
The board has a faulty connection Ensure that all connectors to the front end
to the front end board. board are seated correctly.
The SpO2 module malfunctioned. Replace the SpO2 module. See "Removing
the SpO2 Module" on page 5-22.
The system board malfunctioned. Replace the system board. See "Removing
the System Board" on page 5-23.
SpO2 measurements A problem external to the monitor Ensure that all external SpO2 reading
are unreliable. occurred. For example, excessive requirements are met and that the patient is
patient movement. not moving excessively. For more
information about taking SpO2
measurements, see the CTG7 Fetal/
Maternal Monitor Instructions for Use.
The system board has Replace the system board. See "Removing
malfunctioned. the System Board" on page 5-23.
The ECG module has Replace the ECG module. See "Removing the
malfunctioned. ECG Module" on page 5-26.
I am getting unreliable The ECG leads are off. Ensure that the ECG leads are connected.
ECG readings.
There has been some Ensure that all external ECG reading
external problem. requirements are met and that the patient is
not moving excessively. Ensure proper skin
preparation has been performed.
The system board has Replace the system board. See "Removing
malfunctioned. the System Board" on page 5-23.
The ECG module has Replace the ECG module. See "Removing the
malfunctioned. ECG Module" on page 5-26.
The recorder motor cable is Ensure that the recorder motor cable is
disconnected. properly connected to the recorder board.
The recorder runs The paper is installed Load the paper correctly.
normally, but the paper incorrectly (the wrong side
remains blank, or of the paper is facing up).
contains blurry or
incorrect traces. The thermal printhead is Ensure that the thermal printhead cable is
disconnected. properly connected to the recorder board.
Warning Before performing any service on the CTG7 Fetal/Maternal monitor, power off the monitor and
disconnect it from the AC mains supply, and remove the battery first.
5. When installing the battery, check the polarity indicators on the battery cover and insert the new battery
according to the indicators.
6. Install the battery cover. Note insert the plastic lock pillar into the hole in the middle of the spring lock.
Warning Ensure that the battery is completely inserted into the monitor and that the battery door is firmly closed.
An improperly installed battery could result in serious injury to patients if it falls out of the monitor.
Before putting a new battery into use, perform at least two complete reconditioning cycles. This improves the
battery life and increases performance specifications. A reconditioning cycle is complete (charging and
discharging the battery) when the monitor powers off from lack of battery power. Perform a recondition when
battery performance is shortened or when the battery is stored for 2 months or more.
To recondition the battery:
1. Disconnect the monitor from the patient and turn it off.
2. Place the battery you want to recondition into the monitor battery compartment (see section 5.2
"Removing/Replacing the Battery" on page 5-1).
3. Connect the monitor to AC power and continuously charge the battery for more than 8 hours.
4. Disconnect the monitor from AC power and power the monitor with the battery until the monitor turns
off.
5. Connect the monitor to AC power and continuously charge the battery for more than 8 hours.
Reconditioning is complete.
Interface Film
2. Pull out the fuse holder and remove and replace the fuse as shown. To replace the fuse holder, push it
back into the power socket until it snaps into the place.
5.4 Separating the Top Cover Assembly and the Bottom Housing Assembly
To separate the top cover assembly and the bottom housing assembly:
1. Carefully place the monitor upside down on a soft surface.
2. Remove the four M3x15 screws securing the top cover assembly to the bottom housing assembly.
Screws
3. Holding both the top cover and bottom housing assemblies together and place the monitor upright again.
5. Remove the system board connector cable to separate the top cover assembly from the bottom housing
assembly.
Bottom
Top Cover Housing
Assembly Assembly
Print Keypad
Navigation Wheel
Board
Thermal Printer
Head Assembly
Metal Bar A
2. Remove all connecter cables as shown.
2. Install three M3x6 screws on the three corners of the recorder board as shown.
3. Insert the LCD drive cable into the slot and push the lock in the direction as shown.
5. Use Hexagon nut driver to install the nut. Install the M3x6 screw on the rest corner of the recorder board
as shown.
Metal Bar B
2. Remove the navigation wheel cable and the six M3x8 screws.
2. Turn the top cover back and press the printer key to open the printer door.
Printer Button
Printer Door
3. Turn the top cover and gently remove the thermal print head from the plastic shell.
2. Pull out one side of the printer door in the direction as shown.
Printer Door
Compaction
Paper Pane
Step 2:
Press Down Step 1:Push
3. Loosen the right side of the compaction paper pane. Hold the compaction paper pane and remove it in
the direction as shown.
4. Note the spring on the left side of the compaction paper pane.
Spring
on A Side
A Side B Side
Spring
Long Side
Short Side
Hole on A Side
2. Insert the short side of the spring through the hole on the compaction paper pane.
3. Turn the top cover back. Insert the A side of the compaction paper pane with the spring into the hole as
shown. The long side of the spring should be placed into the slot show in the picture.
Step 1:
Insert the Long Side of the Sprint Here
Back of Printer Button
Step 2:
Insert the Compaction Paper Pane A
Side into the Hole.
4. Insert the B side of the compaction paper pane into the hole as shown and press the compaction paper
pane down. Use flat head screw driver if needs.
Press Down
Pull upright
3. Lift the LCD screen . You will find two plastic covers at the bottom of the two sides of the LCD screen.
Plastic Caps
Left Side
Right Side
6. Separate the LCD display assembly from the top cover assembly.
5.5.9.1 Removing the LCD Drive Module and the LCD Screen
2. Remove the alarm LED cable, LCD display cable, and LCD drive cable.
3. Remove four M3x6 screws and remove the LCD drive module.
4. Remove the LCD insulation plastic sheet and remove the LCD screen.
LCD Insulation
Plastic Sheet
Step 2:
Push upward
Step 1:
Loose clips
Lock Button
Springs
2. Use the flat head screw driver to press the two springs as shown.
3. Press the lock button in the direction as shown to install the lock button.
• ECG module
• AC/DC power module
• Power socket
• Interface board
• Battery charge board
System Board
NIBP Module
AC/DC Power
Transducer Holder Module
SpO2 Module
Speaker
ECG Module
Fetal Monitoring
(FM) Module
Probe Socket
2. Gently unplug the SpO2 board from the system board. Note the connector pins between the SpO2 board
and the system board.
FM Cable
NIBP Cable
Netport Cable
ECG Cable
Power Cable
FM Cable
SpO2 Cable
ECG Cable
(To System Board)
ECG Cable
(To ECG Probe)
Power Cable
Electric Foam
(5 x 8 x 63 mm)
Ground Wire
Electric Foam
(8 x 8 x 63 mm)
Plate A
3. Open the battery door (see section 5.2 "Removing/Replacing the Battery" on page 5-1)and remove the
metal plate B.
Plate B
4
5
6
10
7
8
9
1 14
12 11
2
10
4
13
5 9
15
7
6
13 PCA BAT Adapte Board CHG00 V1.3 Pb Free (Battery charger 453564304511
board)
15 3T INSUL System Board Film PVC (System board insulation plastic 453564278601
sheet)
30 PCA BAT Adapte Board CHG00 V1.3 Pb Free (Battery charger 453564304511
board)
34 CBL 2x8PIN, 2.0, 120mm (keypad board and printer dirve board 453564311721
connector cable)
40 3T CBL 5PIN, 2.54, L110mm (FM cable and Netport cable) 453564278811
Warning Use of accessories, transducers, and cables other than those specified may result in increased emissions
and/or decreased immunity of the CTG7 Fetal/Maternal monitor.
The CTG7 Fetal/Maternal monitor 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.
Caution The following CTG7 Fetal/Maternal monitor accessories are sensitive to electrostatic discharge
during fetal/maternal monitoring:
• SpO2
Follow these guidelines to avoid electrical fast transient bursts and conducted disturbances:
– Do not use the CTG7 Fetal/Maternal monitor on mains power where other devices with
radio-frequency transmitters are connected.
– Keep any accessories for the CTG7 Fetal/Maternal monitor far away from devices with
radio-frequency transmitters.
RF emission Class A The CTG7 Fetal/Maternal monitor is suitable for use in all
establishments, other than domestic establishments and those
CISPR 11
directly connected to the public low-voltage power supply network
Harmonic emissions Class A that supplies buildings used for domestic purposes.
IEC 61000-3-2
Electrical fast ±2KV for power ±2KV for power Mains power quality should be that of a typical
transient/burst supply lines supply lines commercial or hospital environment.
IEC 61000-4-4
Surge ±1KV differential ±1KV differential Mains power quality should be that of a typical
mode mode commercial or hospital environment.
IEC 61000-4-5
±2KV common mode ±2KV common
mode
Table 7-2 Electromagnetic Immunity for all Equipment and Systems (Continued)
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency (50/ 3A/m 3A/m Mains power quality should be that of a typical
60Hz) magnetic field commercial or hospital environment.
IEC61000-4-8
7
d P 800 MHz to 2.5 GHz
E1
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 strength in the location in which the CTG7 Fetal/Maternal
monitor is used exceeds the applicable RF compliance level above, the CTG7 Fetal/Maternal monitor should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be neces-
sary, such as reorienting or relocating the CTG7 Fetal/Maternal monitor.
2. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1. For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in metres (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.
T U
test UT 3000 monitor
fetal recorder maintenance, 2-11 visual inspection, 2-1
frequency, 2-2
UT3000 monitor
guidelines, 2-1
back cover exploded diagram, 6-3
performance tests, 2-3
main frame exploded diagram, 6-3
ECG, 2-7
fetal monitoring, 2-4 UT3000 monitor, performance tests
NIBP, 2-4
NIBP, 2-7
NIBP accuracy, 2-5
NIBP calibration, 2-6 calibartion, 2-5
NIBP leakage, 2-6 power supply and battery, 2-4
NIBP linearity, 2-6
NIBP overpressure, 2-7 UT3000 monitor, test
power supply and battery, 2-4 required equipment, 2-2
pulse SpO2, 2-7
speaker, 2-12 UT3000 monitor, troubleshooting
visual, 2-4 performace tests, 4-5, 4-6
recorder, 2-12
UT3000, test
recording, 2-3
performance tests
required equipment, 2-2
fetal monitoring, 2-4
safety tests, 2-8
electrical isolation diagram, 2-8
functional earth and enclosure leakage current, 2-10
patient leakage, 2-10
system enclosure leakage, 2-9
transducer test, 2-11
TOCO, 2-11
ultrasound, 2-11
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