CTG7 SG Eng 3.0 [PDF]

Zitiervorschau

CTG7 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. The product has passed the CE certification.

Manufacturer Shenzhen Goldway Industrial Inc. Registered/Production Address: No. 2 Tiangong Road, Nanshan District, Shenzhen, P. R. China 518057 Tel: +86 755 26980999 Fax: +86 755 26980222

Edition Third Edition: September 2012 Shenzhen Goldway Industrial Inc. All Rights Reserved.

Safety Conventions The guide uses the following conventions for Notes, Cautions, and Warnings. Note — A Note calls attention to an important point in the text.

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.

ii

CTG7 Fetal/Maternal Monitor Service Guide

Explanation of Symbols The following symbols appear on the monitor and its packaging.

Table 1 Monitor Symbols Symbol

Description

Symbol

Description

CE mark

Caution, consult accompanying documents.

Keep dry

Temperature limitation

Atmospheric pressure limitation

Humidity limitation

Keep upright

Fragile, handle with care

Recycle packaging

Recyclable

Maximum stacking

On/Standby key

Alarm silence key

TOCO calibration key

Event mark key

Print key

Sound source key

NIBP key

Power LED

Charging LED

CTG7 Fetal/Maternal Monitor Service Guide

iii

Table 1 Monitor Symbols (Continued) Symbol

iv

Description

Symbol

Description

B applied part

CF applied part

US transducer connector

TOCO probe connector

Manual quickening marker connector

Fetal waker device connector

NIBP cuff connector

ECG connector

SpO2 probe connector

Fuse

Dangerous Voltage

Equipotential grounding

Signal input and output

Compliance with WEEE standard

Protective grade

Protective grade

Manufacturer address

Date of manufacture

Configuration number

Batch code

EU representatives

Catalogue number

Serial number

Consult instructions for use

CTG7 Fetal/Maternal Monitor Service Guide

Regulatory and Safety Specifications 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

Product Support and Warranty Information Complete the warranty card and send it back to Goldway. Goldway warranties the monitor for one year. Keep the packing case 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.

•

monitor is located in a typical hospital environment.

•

product is used according to this guide.

Goldway is not responsible for damage to the monitor when: •

damage is caused by:

•

– improper operation. – improper connection of the monitor to other devices. – accidental impact. the monitor is altered without written authorization from Goldway.

•

the serial number of the monitor is removed or becomes illegible.

CTG7 Fetal/Maternal Monitor Service Guide

v

After Sales Service When you need product support: 1. Contact your local Goldway representative. 2. For further support, contact Goldway’s Customer Service Department. Customer Service Department of Shenzhen Goldway Industrial Inc. No. 2 Tiangong Road, Nanshan District, Shenzhen, P. R. China 518057 International call center hours: Monday – Friday (except Chinese statutory holidays) BJT 08:30 – 12:00, 13:00 – 17:30 (GMT+8) Tel: +86 755 86278308 Fax: +86 755 86278392 E-mail: [email protected] Service and support are available in Chinese and English only. Before calling for service, note the following information: •

Model and serial number of the monitor

•

Monitor problem

Safety Standards Table 2 Safety Standards Parameter

Specification

Protection Class

Class I, anti-shock, externally and internally powered equipment, per IEC 60601-1

Degree of Protection

Anti-shock degree as combination of B and CF applied part Degree of water proof as IPX1, US and TOCO transducers as IPX8 According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

Sterilization and disinfection

As recommended by manufacturer

Mode of Operation

Continuous

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.

vi

CTG7 Fetal/Maternal Monitor Service Guide

Warning

The monitor is not for home use. The monitor is not for diagnostic or therapeutic use. 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. Never use the monitor on more than one patient at a time. Do not modify this equipment without authorization of the manufacturer. Never use the monitor in an environment of anesthetic gases. 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.

CTG7 Fetal/Maternal Monitor Service Guide

vii

If patient data is lost, closely monitor the patient or replace the monitor immediately. 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.

viii

CTG7 Fetal/Maternal Monitor Service Guide

Table of Contents 1 Introduction 1.1 Who Should Read This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2 Repair Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3 Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3.1 Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3.2 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4 CTG7 Fetal/Maternal Monitor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4.1 Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.5 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.6 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7 CTG7 Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.7.1 Main Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.8 Demo Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.9 Mounting the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-1 1-1 1-2 1-2 1-2 1-2 1-3 1-3 1-3 1-4 1-4 1-5 1-6

2 Testing and Maintenance 2.1 Manufacturer’s Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Testing and Inspecting Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3 Recommended Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 Test Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6 Performance Verification Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.1 Visual Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.2 Power Supply and Battery Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.3 Fetal Monitoring Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4 NIBP Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4.1 NIBP Accuracy Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4.2 NIBP Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4.3 Leakage Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4.4 Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.4.5 Overpressure Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.5 SpO2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.6.6 ECG Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.1 Electrical Isolation Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.2 System Enclosure Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.3 S(1): Sum of Functional Earth and Enclosure Leakage Current Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.4 Patient Leakage Current With Mains Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.5 Fetal Recorder Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.6 Transducer Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.6.1 Ultrasound Transducer Electrical Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.6.2 Toco Transducer Electrical Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7.7 Speaker Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.8 Recorder Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9 Upgrading the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.1 Upgrade Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.2 Installing the USB-RS 232 Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.3 Creating a Hyper Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.4 Updating the Program File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.5 Updating the Data File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.9.6 Updating the Language Resource File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CTG7 Fetal/Maternal Monitor Service Guide

2-1 2-1 2-2 2-2 2-3 2-3 2-4 2-4 2-4 2-4 2-5 2-6 2-6 2-6 2-7 2-7 2-7 2-8 2-8 2-9 2-10 2-10 2-11 2-11 2-11 2-11 2-12 2-12 2-12 2-12 2-12 2-15 2-17 2-20 2-21

Contents-1

2.9.7 Language Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

3 Theory of Operation 3.1 CTG7 Fetal/Maternal Monitor Hardware Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2 Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 LCD Display Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.1 LCD Drive Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4 Fetal Recorder (Thermal Printer Unit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4.1 Recorder Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4.2 Thermal Print Head. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5 NIBP Module (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.6 SpO2 Module (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.7 ECG Module (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8 Fetal Monitoring Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.9 System Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.10 I/O Interface Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-1 3-2 3-2 3-2 3-2 3-2 3-2 3-2 3-3 3-3 3-3 3-3 3-3

4 Troubleshooting 4.1 Power Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Display Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3 Alarm Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4 Fetal Monitoring Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.5 NIBP Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.6 SpO2 Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.7 ECG Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8 Recorder Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.9 Performance Verification Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-1 4-2 4-2 4-3 4-4 4-5 4-5 4-6 4-6

5 Repairing the CTG7 Fetal/Maternal Monitor 5.1 Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Removing/Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2.1 Battery Maintenance and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2.2 Reconditioning the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Removing/Replacing the Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.4 Separating the Top Cover Assembly and the Bottom Housing Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5 Disassembling the Top Cover Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.1 Removing the Recorder Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.2 Installing the Recorder Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.3 Removing the Print Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.4 Removing the Thermal Printer Head . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.5 Removing the Printer Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.6 Removing the Compaction Paper Pane. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.7 Installing the Compaction Paper Pane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.8 Removing the Navigation Wheel Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.9 Removing the LCD Display Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.9.1 Removing the LCD Drive Module and the LCD Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.9.2 Removing the Alarm LED Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.9.3 Removing the LCD Lock Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.5.9.4 Installing the LCD Lock Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6 Disassembling the Bottom Housing Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.1 Removing the Transducer Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.2 Removing the SpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.3 Removing the Fetal Monitoring (FM) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.4 Removing the System Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contents-2

5-1 5-1 5-3 5-3 5-4 5-4 5-6 5-7 5-8 5-10 5-11 5-11 5-12 5-13 5-14 5-15 5-17 5-18 5-19 5-19 5-20 5-21 5-22 5-22 5-23

CTG7 Fetal/Maternal Monitor Service Guide

5.6.5 Removing the NIBP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.6 Removing the Speaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.7 Removing the ECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.8 Removing the AC/DC Power Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.9 Removing the Interface Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.10 Removing the Power Socket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.11 Removing the Probe Socket and NIBP Socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.6.12 Removing the Battery Charger Board. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-24 5-25 5-26 5-27 5-27 5-28 5-28 5-29

6 Replacement Parts and Assembly Drawings 6.1 CTG7 Main Assembly Exploded Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2 CTG7 LCD Display Assembly and Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3 CTG7 Top Cover Assembly and Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.4 CTG7 Bottom Housing Assembly and Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.5 Sparts Parts List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6-1 6-2 6-3 6-4 6-5

7 Electromagnetic Compatibility 7.1 Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Guidance and Manufacturer's EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2.1 Electromagnetic Emissions for all Equipment and Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2.2 Electromagnetic Immunity for all Equipment and Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting . . . . . . . . . . . . . . . . . . . . . . . . . 7.2.4 Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CTG7 Fetal/Maternal Monitor Service Guide

7-1 7-2 7-2 7-2 7-4 7-5

Contents-3

Contents-4

CTG7 Fetal/Maternal Monitor Service Guide

1 Introduction This manual describes how to troubleshoot and repair the CTG7 Fetal/Maternal Monitor and recorder. For more information on maintaining, using, and cleaning the monitor during normal use, see the CTG7 Fetal/ Maternal Monitor Instructions for Use.

1.1 Who Should Read This Guide This guide is for qualified service personnel or technicians responsible for troubleshooting, repairing, and maintaining the CTG7 Fetal/Maternal Monitor (Service Number is 866084). Before you start to service or repair the product, read this service guide and the CTG7 Fetal/Maternal Monitor Instructions for Use. You should also be familiar with the following: 1. Standard medical equipment installation procedures. 2. Current conventional technical terms used in this manual.

1.2 Repair Strategy This service guide will help you determine whether a fault is a hardware or software problem. Repair and/or replacement of individual board components is not supported and should never be attempted. The disassembly, repair, or replacement of the CTG7 Fetal/Maternal Monitor and its accessories without the written authorization of Goldway will invalidate the warranty. •

The main replaceable parts are as follows:

•

– SpO2 module – System module – LCD display module – Keypad board – Alarm LED board – Navigation wheel board – Fetal monitoring module – NIBP module – ECG module – Speaker – Thermal printer head – Recorder board – Battery – AC/DC power module You can also replace the following accessories: – – – – –

Transducers Fetal waker device Event marker NIBP cuff SpO2 sensor

For diagrams and part numbers, see Chapter 6 "Replacement Parts and Assembly Drawings". For repair details, see Chapter 5 "Repairing the CTG7 Fetal/Maternal Monitor". For after-repair tests, see section 2.4 "Testing and Inspecting Guidelines" on page 2-1.

CTG7 Fetal/Maternal Monitor Service Guide

1-1

Site Requirements

1.3 Site Requirements 1.3.1 Space Requirements Situate the CTG7 Fetal/Maternal Monitor in a place where the clinical staff is able to monitor the patient with relative ease, with all patient connectors and controls readily available, and the display clearly visible. The location should also allow access for service personnel without excessive disruption and should have sufficient clearance all around to allow air circulation. For detailed physical specifications of the CTG7 Fetal/Maternal Monitor, see Appendix B, “Specifications” in the CTG7 Fetal/Maternal Monitor Instructions for Use.

1.3.2 Environmental Requirements The environment where clinicians will use the CTG7 Fetal/Maternal Monitor should be free from vibration, dust and corrosive or explosive gases. The ambient operating and storage conditions for the CTG7 Fetal/ Maternal Monitor must be observed. If these conditions are not met, system accuracy could be affected and damage might occur.

Environmental Specifications Temperature Range

Relative Humidity

Barometric Pressure

Operating

10oC - 40oC (50oF - 104oF)

Storage and transportation

-20oC - 55oC (-4oF - 131oF)

Operating

80% (non-condensing)

Storage and transportation

95% (non-condensing)

Operating

70 kPa to 106 kPa

Storage and transportation

50 kPa to 106 kPa

Table 1-1 Environmental Specifications for CTG7 Fetal/Maternal Monitor

1.4 CTG7 Fetal/Maternal Monitor Overview You can use the CTG7 Fetal/Maternal monitor to monitor: fetal heart rate (FHR) externally using ultrasound, uterine activity using an external TOCO transducer, optional maternal ECG, optional maternal non-invasive blood pressure (NIBP) and optional SpO2 (pulse oximetry). Measurements are displayed on a 7-inch color display as numerics and waveforms. The built-in recorder documents fetal and maternal measurements.

Figure 1-1 CTG7 Fetal/Maternal Monitor 1-2

CTG7 Fetal/Maternal Monitor Service Guide

Indications for Use

1.4.1 Power Specifications The following table indicates the power specifications. Table 1-2 Power Specifications

AC Power Parameter

Specification

Mains power input

AC 100 - 240V, 50Hz/60Hz

Power input

100VA

Fuse

T1.6AH, 250V

Battery Power Parameter

Specification

Capacity

Lithium ion, 11.1V/7200mAh

Charging time

Approximately 8 hours

Maximum operating time

At least 4 hours with continuous FHR and TOCO monitoring

Charge mode

Automatic (with charge protection feature) when the monitor is powered by an AC power source.

Discharge protection

On battery power, the monitor powers off when the battery is depleted.

1.5 Indications for Use The CTG7 Fetal/Maternal monitor is for use by licensed healthcare professionals whenever there is a need for monitoring the physiological parameters of pregnant women and their fetuses. Physiological data, system alarms, and patient data analysis will be available to the user from the monitor. Physiological data includes, but is not restricted to FHR, TOCO, maternal ECG, maternal non-invasive blood pressure and pulse oximetry.

1.6 Intended Use The intended use of the CTG7 Fetal/Maternal monitor is for monitoring, recording, and alarming of multiple physiological parameters of mother and fetus in healthcare environments. Additionally, the monitor is intended for use in transport situations. It could be used in the following clinical environments: •

General clinics

•

Gynecology clinics

•

Pre-delivery room

•

Labor and delivery room

CTG7 Fetal/Maternal Monitor Service Guide

1-3

CTG7 Configurations

1.7 CTG7 Configurations The CTG7 Fetal/Maternal Monitor includes several configurations.

1.7.1 Main Components The monitor contains these main components: •

Main unit with recorder

•

FHR US transducer (second transducer for twin monitoring optional)

•

TOCO transducer

•

Event marker

•

Fetal waker device (optional)

•

Maternal ECG (optional)

•

Maternal NIBP and SpO2 (optional)

The following table lists the available features for the CTG7 Fetal/Maternal Monitor. In the table, a solid circle indicates a standard feature and a hollow circle, an optional feature.

Table 1-3 CTG7 Fetal/Maternal Monitor Configurations

Feature

Standard/Optional

Main unit with recorder

●

Fetal heart rate (FHR1)

●

Fetal heart rate (FHR2)

o

TOCO monitoring

●

Maternal ECG1

o

Maternal NIBP and SpO22

o

Event marker

●

Waker device

o

Serial port (for software upgrade only)

●

1. Maternal ECG cannot be ordered without the maternal NIBP and SpO2 options. 2. Maternal NIBP and SpO2 options must be ordered together.

1-4

CTG7 Fetal/Maternal Monitor Service Guide

Demo Mode

1.8 Demo Mode Demo mode lets you demonstrate the monitor without actually monitoring parameters. To configure Demo mode: 1. Rotate the navigation wheel to menu bar and press the wheel. 2. Rotate the navigation wheel to the System menu and press the wheel. 3. Rotate the wheel to Sys. Maint. and press the wheel. A Password window appears. 4. Enter the password 8727 and rotate the navigation wheel to OK and press the wheel. Note — The password is only available for selecting Demo Mode.

5. Rotate the navigation wheel to Demo and press the wheel. 6. Rotate the navigation wheel to select ON and press the wheel. 7. Rotate the navigation wheel to OK enter Demo Mode and exit the Sys. Maint. menu. The monitor enters Demo Mode. To return the monitor to regular monitoring: 1. Repeat the steps 1- 5. 2. Rotate the navigation wheel to select OFF and press the wheel. 3. Rotate the navigation wheel to OK to exit the Sys. Maint. menu. The monitor ends Demo Mode.

CTG7 Fetal/Maternal Monitor Service Guide

1-5

Mounting the Monitor

1.9 Mounting the Monitor The CTG7 Fetal/Maternal Monitor can be installed on a roll stand. Before mounting the monitor, attach the adapter plate. To mount the adapter plate to the CTG7 Fetal/Maternal Monitor: 1. Attach the adapter plate to the bottom of the monitor with the four screws.

Figure 1-2 Adapter Plate of CTG7 Fetal/Maternal Monitor 2. Attach the metal mounting bracket to the bottom of the adapter plate.

Figure 1-3 CTG7 Fetal/Maternal Monitor Mounting Hardware For information on mounting the monitor on the roll stand, see the Roll Stand Installation Guide.

1-6

CTG7 Fetal/Maternal Monitor Service Guide

2 Testing and Maintenance This chapter describes how to inspect and maintain the CTG7 Fetal/Maternal monitor. It contains the testing and maintenance procedures to ensure proper functioning of the monitor and accessories. The chapter also contains information on preventive maintenance, performance assurance, and safety guidelines. Perform the procedures as indicated in Table 2-1 "Testing Guidelines". The recommendations in this table do not supersede local requirements. For more information on how to clean and sterilize the monitor, transducers, and accessories, see Chapter 11 “Cleaning and Care” in the CTG7 Fetal/Maternal Monitor Instructions For Use.

2.1 Manufacturer’s Responsibilities If a maintenance plan is not performed, the monitor can record inaccurate measurements, causing potential hazards to both operators or patients. In these cases – unless otherwise agreed – the manufacturer is not responsible.

2.2 Testing and Inspecting Guidelines Table 2-1 "Testing Guidelines" lists the tests that you should complete after performing monitor installations, repairs, or software upgrades.

Table 2-1 Testing Guidelines

After

Perform These Tests

Installing or updating software

Visual Inspection Power Supply and Battery test Performance Verification Tests

Opening the monitor

Speaker Test Power Supply and Battery Test NIBP Test All Safety Tests

Replacing any internal parts (except the SpO2 module and fetal monitoring module)

Visual Inspection Power Supply and Battery Test Performance Verification Tests NIBP Test Speaker Test ECG Test All safety Tests

Replacing the fetal monitoring module

Visual Inspection Power Supply and Battery Test Fetal Monitoring Module Test All Safety Tests

Replacing the SpO2 module

Visual Inspection Power Supply and Battery Test Pulse SpO2 Test All Safety Tests

CTG7 Fetal/Maternal Monitor Service Guide

2-1

Recommended Frequency

2.3 Recommended Frequency Perform the test procedures at the recommended frequency outlined in Table 2-2 on page 2-2.

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.

Table 2-2 Recommended Frequency

Tests

Frequency

Preventive Maintenance NIBP Calibration

Once a year, or more often if specified by local laws.

Performance • NIBP Accuracy Test

Once a year, or if you suspect the measurement is incorrect.

• SpO2 Test • Fetal Monitoring Test • ECG Performance Safety (In accordance with IEC 60601-1) • System Enclosure Leakage Current • Ground Integrity • Patient Leakage Current With Mains Voltage

Once every 12 months, and after repairs where the unit has been opened (front and back separated) or the monitor has been damaged by impact.

Other Regular Tests • Visual Inspection

Before each use.

• Recorder Maintenance

Once a year, or if the printout is degraded.

• Testing Transducers

Once a year, or if you suspect the measurement is incorrect.

2.4 Required Equipment The following table lists the test equipment needed in order to perform the tests. Many of the tests use the standard accessories shipped with the monitor. Table 2-3 Required Test Equipment

2-2

Test

Equipment

“Visual Test” on page 2-4

None

“Power Supply and Battery Test” on page 2-4

None

“Fetal Monitoring Test” on page 2-4

Fetal simulator & Fetal monitoring probe

“SpO2 Test”on page 2-7

SpO2 simulator & SpO2 cable

CTG7 Fetal/Maternal Monitor Service Guide

Test Recording

Table 2-3 Required Test Equipment (Continued)

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

“NIBP Calibration” on page 2-6

None

“Speaker Test” on page 2-12

None

“Safety Tests” on page 2-8

Multimeter

2.5 Test Recording Authorized personnel report test results back to Goldway to add to the product development database. Hospital personnel, however, do not need to report results. The following table describes what to record in the service record after you complete the tests in this chapter. Table 2-4 Test Recording

Test

What to Record

Visual Test

VI:P1 or VI:F2

Power Supply and Battery Test

PB:P or PB: F

Fetal Monitoring Test

No need to report

Noninvasive Blood Pressure (NIBP) Test

NT:P/X31/X2 or NT:F/X1/X2 NT:P/X3 or NT:F/X3 NT:P/X4 or NT:F/X4

SpO2 Test

No need to report

ECG Test

ET: P or F

Safety Test

S(1): P/X1/X2 or S(1): F/X1/X2 S(2): P/X1 or S(2): F/X1

1. P = pass 2. F = fail 3. X = measured value as defined in test in this chapter.

2.6 Performance Verification Tests This section details the periodic maintenance recommended for the monitor, transducer and accessories. Service personnel must inspect the monitor thoroughly and verify performance when before the monitor is put into service and every 12 months or whenever necessary thereafter.

CTG7 Fetal/Maternal Monitor Service Guide

2-3

Performance Verification Tests

2.6.1 Visual Test To perform the visual test: 1. Inspect the system for obvious signs of damage; for example, cracks, cuts, or breakage. 2. Check all external cables and accessories; for example, cuts, kinks, wrong connections. 3. Ensure that all markings and labeling are legible. 4. Check for any obstructions to mechanical parts. The excepted test result is that the system has no obvious signs of damage or obstruction.

2.6.2 Power Supply and Battery Test To perform a power supply and battery test: 1. Plug the monitor into an AC power outlet and 2. Power on the monitor. 3. The power LED should glow in one of the following colors: – Green: the monitor is powered on and working normally. – Yellow: the monitor is connected to AC power but not turned on.The internal battery is charging. 4. Unplug the AC power cord. 5. Verify that the power LED is green and a battery icon displays in the status box on the screen.

2.6.3 Fetal Monitoring Test 1. Set the fetal simulator to 120 bpm, then attach the fetal monitoring probe on the analog signal generator of the fetal simulator. 2. Set the baseline value of the uterine contraction to 20. Make sure that the uterine contraction probe faces up and the uterine contraction pressure is 0. 3. Place a 50g weight on the uterine contraction probe. 4. Set the volume of the fetal heart to level 5. 5. Observe if the fetal heart pulse is 120 +/- 2bpm, and the volume of fetal heart is normal. 6. The uterine contraction pressure should be 46 +/- 10. The fetal monitoring module test is complete.

2.6.4 NIBP Test Always check to see if the cuff or hose has a leak. Replace the cuff or hose as necessary. If a pressure reading is more than ±3mmHg inaccurate when compared with a precise blood pressure meter, the monitor needs pressure calibration. The following tests verify the performance of the non-invasive blood pressure measurement.

2-4

•

NIBP accuracy

•

NIBP calibration procedure (if required)

•

Leakage test

•

Linearity test

•

NIBP overpressure valve

CTG7 Fetal/Maternal Monitor Service Guide

Performance Verification Tests

2.6.4.1 NIBP Accuracy Test 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.

Figure 2-1 NIBP Accuracy Tubing Connection 2. Connect the other end of the tubing to the expansion chamber (500ml cylinder). 3. Press the TOCO calibration key. 4. Press the navigation wheel and roate the wheel to select the NIBP screen.

NIBP screen

5. Press the navigation wheel. The NIBP menu appears. 6. Rotate the navigation wheel to Work mode and set it to Test.

7. Squeeze the manometer pump to apply a pressure of 50mmHg.

CTG7 Fetal/Maternal Monitor Service Guide

2-5

Performance Verification Tests

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". 2.6.4.2 NIBP Calibration To calibrate the NIBP module: 1. Press the TOCO calibration key. 2. Press the navigation wheel and roate the wheel to select the NIBP screen. 3. Press the navigation wheel. The NIBP menu appears. 4. Rotate the wheel to Calibration and press the wheel. 5. Rotate the wheel to select a value most close to Vadj. NIBP calibration is complete. 2.6.4.3 Leakage 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. 2.6.4.4 Linearity Test 1. Reduce the manometer pressure to 150mmHg. 2. Wait a few seconds for the measurement to stabilize. 3. After the measurement is stabilized, compare the manometer value with the displayed value. 4. Document the value displayed by the monitor (X4). 5. If the difference is greater than 3 mmHg, calibrate the NIBP measurement (see section "NIBP Calibration").

2-6

CTG7 Fetal/Maternal Monitor Service Guide

Performance Verification Tests

2.6.4.5 Overpressure Test To test the overpressure: 1. Press the TOCO calibration key. 2. Press the navigation wheel and roate the wheel to select the NIBP screen. 3. Press the navigation wheel. The NIBP menu appears. 4. Rotate the wheel to Work mode and set it to Test. 5. Rotate the wheel to Patient Type and set it to Adult. 6. Squeeze the manometer pump and apply a pressure of 290 mmHg. 7. Press the NIBP key and verify that the valves are open. 8. Release the pressure on the manometer.

2.6.5 SpO2 Test To perform the pulse SpO2 test: 1. Power off the Oximetry simulator (SpO2 simulator). 2. Connect the SpO2 simulator to the SpO2 connector on the monitor via a SpO2 cable. 3. Turn on the SpO2 simulator, set the SpO2 value to 95% and the pulse rate to 100 bpm. 4. Verify that the SpO2 value displayed on the monitor is between 92% and 99%. 5. Verify that the SpO2 waveform displayed on the monitor is normal. 6. Verify that the pulse value displayed on the monitor is between 96 and 104. 7.

Turn off the SpO2 simulator and unplug the SpO2 cable.

SpO2 test is complete.

2.6.6 ECG Performance This test checks the performance of the ECG measurement. To perform the ECG test: 1. Connect the ECG patient cable to the ECG connector on the socket panel of the monitor. 2. Connect the other end of the ECG patient cable to the ECG simulator. 3. Configure the ECG simulator to: – ECG sinus rhythm – HR = 80 bpm, or a rate of your choice. 4. Verify that the displayed ECG wave and HR value (+/- 2bpm) on the monitor correlate to the values you selected on the ECG simulator. For example, if you selected 80 bpm, the displayed value on the ECG monitor should be 78-82 bpm. 5. Redo the test, selecting several heat rates on the ECG simulator: 80, 100, 160. 6. If you do not get the results in step 4, see Chapter 4, "Troubleshooting".

CTG7 Fetal/Maternal Monitor Service Guide

2-7

Safety Tests

2.7 Safety Tests Use the following safety test procedures to verify safe installation or service. 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 and in the US use UL2601-1. The Metron Report should print results with the names listed below, together with other data. 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.

The monitor safety tests include: •

System Enclosure Leakage

•

Ground Integrity

•

Patient Leakage Current With Mains Voltage

To perform these tests, you need a Multimeter.

2.7.1 Electrical Isolation Diagram The diagram gives an overview of the electrical isolation of the CTG7 Fetal/Maternal Monitor.

Figure 2-2 Electrical Isolation Diagram of the CTG7 Fetal/Maternal Monitor

2-8

CTG7 Fetal/Maternal Monitor Service Guide

Safety Tests

2.7.2 System Enclosure Leakage

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.

CTG7 Fetal/Maternal Monitor Service Guide

2-9

Safety Tests

2.7.3 S(1): Sum of Functional Earth and Enclosure Leakage Current Test

Figure 2-5 Protective Earth Continuity Expected Test Results: With mains cable, maximum impedance x = 100 mOhms (IEC 60601-1 and UL2601-1). This measures impedance of Protective Earth (PE) terminal to all exposed metal parts of Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE). Test current 25 Amp applied for 5 to 10 seconds. Report the highest value. You can find metal parts of the device: • In the bottom housing (accessed by opening the recorder door). • In the mounting bracket located on the recorder (after you attached the monitor to the recorder). • In the connectors on the side or the back of the monitor.

2.7.4 Patient Leakage Current With Mains Voltage

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.

2-10

CTG7 Fetal/Maternal Monitor Service Guide

Safety Tests

2.7.5 Fetal Recorder Maintenance Clean the recorder platen, thermal printhead and paper sensor at least once a year, or when needed (when traces become faint). Clean the assemblies as follows: •

Clean the recorder platen with a soft lint-free cloth.

•

Soak a cotton swab in alcohol and gently wipe the surface of the thermal printhead of the recorder.

•

Check the paper sensing mechanism is dust free.

2.7.6 Transducer Test 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.

2.7.6.1 Ultrasound Transducer Electrical Check To test an ultrasound transducer: 1. Power on the monitor and the recorder. 2. Connect the transducer to the fetal monitor. 3. Select the fetal heart sound for this channel. 4. Increase the loudspeaker volume to an audible level. 5. Move the transducer back and forth over a solid surface, or the hand as shown.

6. A sound should be heard. 2.7.6.2 Toco Transducer Electrical Check To test a Toco transducer: 1. Power on the monitor and the recorder. 2. Connect the transducer to the fetal monitor. 3. Gently apply pressure to the Toco sensor. 4. Check that the value on the display and paper shows the change in pressure.

CTG7 Fetal/Maternal Monitor Service Guide

2-11

Recorder Test

2.7.7 Speaker Test To test the monitor speaker: 1. Turn on the alarm sound and set the heart rate alarm limits. 2. Check and make sure the monitor provides an alarm sound when the heart rate is out of the alarm limits. 3. Silence the alarm sound and ensure that the monitor provides an alarm sound when the heart rate is out of the alarm limits. 4. Turn on the alarm sound. The speaker test is completed.

2.8 Recorder Test For detailed recorder test procedures, see section “10.2 Loading the Recorder Paper” on page 10-1 in CTG7 Fetal/Maternal Monitor Instructions for Use.

2.9 Upgrading the Software Before you perform a software upgrade, you need the following: 1. PC with CD-ROM 2. USB-RS 232 cable 3. Upgrade software

2.9.1 Upgrade Software Before you update the software, check that the new software includes the contents listed in Table 2-5: Note — The new software will be released by Goldway with Goldway’s Field Change Order (FCO).

Table 2-5 Software

File Name

Description

CTG7_Flash_V*.**.bin1

CTG7 M2560 program file

CTG7_Eeprom_V*.**.bin

CTG7 M2560 data file

CTG7_Language_V*.**.bin

CTG7 language resource file

1. V*.**.bin is the latest version.

2.9.2 Installing the USB-RS 232 Driver To install the USB-RS 232 driver: 1. Insert the USB-RS 232 driverinstallation CD into the PC’s CD driver. 2. Plug the USB-RS232 cable into a USB port on the PC. The system displays a window stating that new hardware has been found.

2-12

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

Figure 2-7 Found New Hardware 3. Select Advanced and click Next.

Figure 2-8 Advanced Installation Selection 4. Select Include this location in the search and click the Browse.

Figure 2-9 Search Driver CTG7 Fetal/Maternal Monitor Service Guide

2-13

Upgrading the Software

5. Select the corresponding CD-ROM drive and select CH340. Cilick OK.

Figure 2-10 Search Folder 6. Click Next and install the driver.

Figure 2-11 Install the Driver 7. Click Finish to complete the driver installation.

Figure 2-12 Complete the Installation

2-14

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

8. Select Start->Control Panel->System->Hardware->Device Manager. The Device Manager window appears. 9. Click Ports (COM & LPT) and find USB 2.0 to COM Device. 10. Record the Port Number name, for example, COM3 (current). The installation is completed.

2.9.3 Creating a Hyper Terminal To create a hyper terminal: 1. Connect the monitor and computer with the USB-RS 232 cable.

Figure 2-13 Connect the Monitor and Computer 2. Select Start→ All Programs → Accessories → Communications → Hyper Terminal → New Windows Hyper Terminal. The Connection Description window appears.

Figure 2-14 Connection Description 3. Enter a name, for example COM3 38400, select an icon for the connection and click ok. The Connection To window appears.

CTG7 Fetal/Maternal Monitor Service Guide

2-15

Upgrading the Software

Figure 2-15 Connect to Window 4. Select the USB-RS232 port number, for example COM3, from the Connect using pull-down menu. Click OK. The COM3 Properties window appears. 5. Set the COM properties as shown and click OK. •

Bits per second: 38400

•

Data bits: 8

•

Parity: None

•

Stop bit: 1

•

Flow control: None

Figure 2-16 COM3 Properties Window The Hypter Terminal widow appears. 6. After the Hyper Terminal window appears, press CTRL + C and connect the monitor to AC power. Figure 2-18 describes the messages that should appear on the terminal window. Note — If the messages do not display as in Figure 2-18, press Enter to refresh.

2-16

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

Figure 2-17 Hyper Terminal Window-1

2.9.4 Updating the Program File To update the program file: 1. Type zero (0) and press Enter. Wait until the letters C appear on the screen.

Figure 2-18 Hyper Terminal Window-2 2. Click Transfer in the Menu of Hyper Terminal window. 3. Select Send File from the drop-down menu.

CTG7 Fetal/Maternal Monitor Service Guide

2-17

Upgrading the Software

Figure 2-19 Send File-1 The Send File window appears.

Figure 2-20 Send File-2 4. Click Browse…and browse to the file CTG7_Flash_V*.**. Bin. Set Protocol to Xmodem. 5. Click Send to start the transfer. A window displays the progress bar and data transferred.

2-18

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

Figure 2-21 Xmodem File Send… Window-1 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.

Figure 2-22 Hyper Terminal Window-3

CTG7 Fetal/Maternal Monitor Service Guide

2-19

Upgrading the Software

2.9.5 Updating the Data File 1. Type the number one (1) and press Enter. Wait until the letters C appear..

Figure 2-23 Hyper Terminal Window-4 2. Click Transfer in the Menu of Hyper Terminal window. 3. Select Send File from the drop-down menu (see Figure 2-19). The Send File window appears.

Figure 2-24 Send File-Eeprom 4. Click Browse… and browse to the file CTG7_ Eeprom_V*.**. Bin. Set Protocol to Xmodem. 5. Click Send to start the transfer.

2-20

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

A window displays the progress bar and data transferred.

Figure 2-25 Xmodem File Send… Window-2 6. After the file is successfully sent, “done” appears in Hyper Terminal window.

Figure 2-26 Hyper Terminal Window-5

2.9.6 Updating the Language Resource File 1. Type the number two (2) and press Enter. Wait until the letters C appear.

CTG7 Fetal/Maternal Monitor Service Guide

2-21

Upgrading the Software

Figure 2-27 Hyper Terminal Window-6 2. Click Transfer in the Menu of Hyper Terminal window. 3. Select Send File from the drop-down menu (see Figure 2-19). The Send File window appears.

Figure 2-28 Send File-3 4. Click Browse… and browse to the File CTG7_Language_V*.**. Bin and Set Protocol to Xmodem. 5. Click Send to start the transfer. A window displays the progress bar and data transferred.

2-22

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

Figure 2-29 Xmodem File Send… Window-3 6. After the file is successfully sent, “done” appears in Hyper Terminal window.

Figure 2-30 Hyper Terminal windows-7

CTG7 Fetal/Maternal Monitor Service Guide

2-23

Upgrading the Software

2.9.7 Language Setting 1. Type the number three (3) and press Enter. Wait until the language type list appears. 2. Note the id of the language which you want to install.

Language type list

Figure 2-31 Hyper Terminal Window-8 3. Type the number four (4) and press Enter to start the load language process.

Figure 2-32 Hyper Terminal Window-9 2-24

CTG7 Fetal/Maternal Monitor Service Guide

Upgrading the Software

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).

Figure 2-33 Hyper Terminal Window-10 5. Press Enter. The message load language success means the software updating is completed.

Figure 2-34 Hyper Terminal Window-11 6. Power off the monitor. 7. Disconnect the USB-RS232 cable from the monitor and PC. 8. Power on the monitor and check the software version. CTG7 Fetal/Maternal Monitor Service Guide

2-25

Upgrading the Software

2-26

CTG7 Fetal/Maternal Monitor Service Guide

3 Theory of Operation This chapter provides an overview of the theory of operation for the CTG7 Fetal/Maternal Monitor.

3.1 CTG7 Fetal/Maternal Monitor Hardware Overview

Figure 3-1 CTG7 Fetal/Maternal Monitor Hardware Overview Note — The items displayed in

in figure 3-1 indicate optional features.

The CTG7 Fetal/Maternal Monitor contains these main components: •

Power Supply

•

– AC/DC power module (+15V) – Lithium Ion LCD Display Assembly

•

Fetal Recorder (Thermal Printer Unit)

•

– Print board – Print head NIBP Module (optional)

•

SpO2 Module (optional)

•

ECG Module (optional)

•

Fetal Monitoring (FM) Module

•

System Board

•

Interface Board – Software update connector

CTG7 Fetal/Maternal Monitor Service Guide

3-1

Power Supply

3.2 Power Supply The power supply includes an AC power module (+15V) and Lithium Ion battery. The power supply is a wide-range input switching unit, with an output of 15V. It is located in the bottom housing assembly. A green LED is located on the monitor controls panel of the top cover assembly. This LED indicates when there is AC input power.

3.3 LCD Display Assembly The LCD display assembly is located in the top cover assembly. It contains these parts: •

LCD screen

•

LCD drive module

•

Alarm LED board

The LCD display assembly consists of a 7” TFT panel, a LCD drive module, and a alarm LED board. Driving signals of the display panel transfer to the system board via FPC (flexible printed circuit). The LED converter connects to the system module via a 2-pin connector wire.

3.3.1 LCD Drive Module The LCD drive module is located in the LCD display assembly. It connects to the system board via recorder board. It controls the display drive and alarm.

3.4 Fetal Recorder (Thermal Printer Unit) The fetal recorder is located in the bottom housing assembly. The recorder contains these parts: •

Recorder board

•

Thermal printer head

3.4.1 Recorder Board The recorder board is located in the top cover assembly. It handles the recorder signals and transfers the power to the print head. The recorder board also connects to the system board and the LCD drive module to offer the communication between the system board and LCD drive module.

3.4.2 Thermal Print Head The printhead prints all data and monitoring information on heat sensitive paper. The print head connects to the print board via FPC and cables. The print head is an integrated unit containing the thermal line printhead (TLPH), paper sensor, and stepper motor.

3.5 NIBP Module (optional) The optional NIBP module is located in the left side of the bottom housing assembly. It connects with the system board via the NIBP connector cable.

3-2

CTG7 Fetal/Maternal Monitor Service Guide

SpO2 Module (optional)

3.6 SpO2 Module (optional) The optional SpO2 module is fixed on the system board. It sends data to the system module via connector pins.

3.7 ECG Module (optional) The optional ECG module is located in the right side of the bottom housing assembly. It connects with the system board via the connection cable.

3.8 Fetal Monitoring Module The fetal monitoring module controls the ultrasonic emission of the ultrasonic transducer, receives the echo signals, and receives the signals from TOCO transducer, marker and waker. The ultrasonic transducer is a pulsed Doppler system with a 1.0 MHz ultrasound frequency and reception rate. The fetal monitoring module processes all collected signals, outputs fetal heart sounds, and transfers all monitoring data to the system module.

3.9 System Module The system module is located in the bottom housing assembly. The main functions of the system module are signal processing, interface communication, and voltage inversion.

3.10 I/O Interface Board The RS232 interface is used for software upgrade. To perform software upgrades, you use a software upgrade tool that connects to a PC.

CTG7 Fetal/Maternal Monitor Service Guide

3-3

I/O Interface Board

3-4

CTG7 Fetal/Maternal Monitor Service Guide

4 Troubleshooting This chapter describes how to troubleshoot monitor and recorder problems. After using this chapter to diagnose a problem, see the "Repairing the CTG7 Fetal/Maternal Monitor", to repair the monitor or to remove and replace a part or assembly.

4.1 Power Problems

Symptom

Possible cause

Action

The monitor does not turn on with AC power. The power LED does not light and the screen is blank.

The power cord is unplugged.

Ensure that the AC power cord is plugged into an outlet.

The monitor turns on with AC power, but does not with battery power.

CTG7 Fetal/Maternal Monitor Service Guide

The power cord is broken. The power supply malfunctioned.

Check the output voltage on the power supply. 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 system module and power supply module.

Fix the connector cable between the system board and power supply module.

Poor contact between the system module and recorder board or recorder board and keypad board.

Fix the connector cable.

The keypad board malfunctioned.

Replace the keypad board. See "Removing the Navigation Wheel Board" on page 5-14.

The recorder board malfunctioned.

Replace the recorder board. See "Removing the Battery Charger Board" on page 5-29.

The system board malfunctioned.

Replace the system board. See "Removing the System Board" on page 5-23.

The battery or connector cable is loose.

Reseat both the battery and battery cable. See "Removing/Replacing the Battery" on page 5-1.

The battery has run out of power.

Charge the battery. If after 48 hours of charging, there is still no battery power, the battery is damaged.

The battery malfunctioned.

Replace the battery. See "Removing/Replacing the Battery" on page 5-1.

The system board malfunctioned.

Replace the system board. See "Removing the System Board" on page 5-23.

4-1

Display Problems

4.2 Display Problems

Symptom

Possible cause

Action

Power is on, but the monitor screen is blank.

There is a bad connection with the printer board.

Ensure that there is a proper connection between the LCD display module and the recorder board.

There is a bad LCD.

Replace the Display assembly. See "Removing the LCD Display Assembly" on page 5-15.

The display board module malfunctioned.

Replace the system module. See "Removing the System Board" on page 5-23.

The LCD cable is not attached correctly.

Open the monitor and reseat the LCD signal cable.

The LCD malfunctioned.

Replace the Display assembly. See "Removing the LCD Display Assembly" on page 5-15.

The display board module malfunctioned.

Replace the system module. See "Removing the System Board" on page 5-23.

There is a bad connection of the keypad board, printing board and system board.

Ensure that all connector cables from the keypad board to the system module are seated correctly.

The monitor keypad or navigation wheel is broken.

Replace the front case. See "Removing the Navigation Wheel Board" on page 5-14 and "Removing the Navigation Wheel Board" on page 5-14.

• Poor contact between the LCD screen and LCD display board module.

• Ensure that the LCD screen cable is well connected to the LCD display board module.

The monitor displays random/ distorted graphics with a white background.

The monitor does not respond to the navigation wheel or front panel buttons.

The monitor display is blank or displays random or distorted graphics.

• LCD screen failure.

• Replace the LCD screen. • Replace the LCD display board module.

• The LCD display board module malfunctioned.

4.3 Alarm Problems

4-2

Symptom

Possible cause

Action

No alarm sound

There is a bad connection to the speaker.

Ensure that the connection to the speaker is correct.

The speaker is bad.

Replace the speaker assembly. See "Removing the Speaker" on page 5-25.

There is a bad connection to the system module.

Ensure that all connectors to the system module are seated correctly.

CTG7 Fetal/Maternal Monitor Service Guide

Fetal Monitoring Problems

4.4 Fetal Monitoring Problems

Symptom

Possible cause

Action

There is no FHR waveform displayed.

There is poor contact with the US transducer.

Ensure that the transducer is connected to the monitor.

The US transducer connects incorrectly.

Ensure that the US transducer is connected to the correct FHR transducer connector.

The US transducer malfunctioned.

Replace the US transducer.

There is poor contact between the fetal monitoring module and the system module.

Restart the monitor, if the problem remains: – Replace the fetal monitoring module. – Replace the system module.

The fetal monitoring module malfunctioned.

After replacing the fetal monitoring module and the system module, if the problem still exists, contact Goldway.

The system module malfunctioned. There is no TOCO data after the TOCO transducer is connected.

There is poor contact of the US transducer.

Ensure that the transducer is connected to the monitor.

The TOCO transducer malfunctioned.

Replace the TOCO transducer.

The FHR waveform is too faint to be observed.

The US transducer is applied incorrectly.

Apply ultrasound transmitter gel to the transducer.

CTG7 Fetal/Maternal Monitor Service Guide

Adjust the transducer on the mother's abdomen.

4-3

NIBP Problems

4.5 NIBP Problems

Symptom

Possible cause

Action

The NIBP cuff does not inflate

The air tube or cuff is bent or twisted.

Straighten the tube or cuff.

There is a leak in the air tube or cuff.

Replace the cuff and ensure that there is no air 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.

• Wrong cuff size. • Incorrect cuff placement.

Use proper cuff size, ensure proper cuff placement.

• The tube is kinked.

• Ensure that the tube is straight and not kinked.

• There is a leak in the air tube or cuff.

• Replace the cuff and ensure that there is no leak in the tube.

• There is a leak in the NIBP socket.

• Replace the NIBP connector.

External problems exist.

• Ensure that all external blood pressure reading requirements are met.

NIBP measurements are not displayed.

• Ensure that the patient is not moving excessively.

NIBP measurements are unreliable.

4-4

The NIBP module setting is incorrect.

Reset the NIBP module.

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 malfunctioned.

Replace the system module. See "Removing the System Board" on page 5-23.

Wrong cuff size or incorrect cuff placement.

Use proper cuff size and ensure proper cuff placement.

The initial pressure setting is incorrect.

Specify the correct intial pressure.

A problem external to the monitor occurred.

Ensure all external blood pressure reading requirements are met and that the patient is not moving excessively.

The NIBP module needs to be calibrated.

Recalibrate the NIBP module. See "NIBP Calibration" on page 2-6.

CTG7 Fetal/Maternal Monitor Service Guide

SpO2 Problems

4.6 SpO2 Problems

Symptom

Possible cause

Action

SpO2 measurements are not displayed.

The SpO2 module is in the learning phase.

Wait until the learning phase is complete.

The SpO2 sensor malfunctioned.

Replace the SpO2 sensor.

The board has a faulty connection to the front end board.

Ensure that all connectors to the front end 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.

A problem external to the monitor occurred. For example, excessive patient movement.

Ensure that all external SpO2 reading requirements are met and that the patient is not moving excessively. For more information about taking SpO2 measurements, see the CTG7 Fetal/ Maternal Monitor Instructions for Use.

SpO2 measurements are unreliable.

4.7 ECG Problems

Symptom

Possible cause

Action

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 system board has malfunctioned.

Replace the system board. See "Removing the System Board" on page 5-23.

The ECG module has malfunctioned.

Replace the ECG module. See "Removing the ECG Module" on page 5-26.

The ECG leads are off.

Ensure that the ECG leads are connected.

There has been some external problem.

Ensure that all external ECG reading requirements are met and that the patient is not moving excessively. Ensure proper skin preparation has been performed.

The system board has malfunctioned.

Replace the system board. See "Removing the System Board" on page 5-23.

The ECG module has malfunctioned.

Replace the ECG module. See "Removing the ECG Module" on page 5-26.

I am getting unreliable ECG readings.

CTG7 Fetal/Maternal Monitor Service Guide

4-5

Recorder Problems

4.8 Recorder Problems

Symptom

Possible cause

Action

A paper empty warning is displayed but the paper is not out.

The drawer is open.

Close the drawer.

There is a paper jam.

Remove the paper and reinstall correctly.

The recorder is using incorrect paper.

Use only recommend recorder paper.

The paper sensor is dirty.

Clean the paper sensor.

The paper sensor malfunctioned.

Replace the thermal print head. See "Removing the Thermal Printer Head" on page 5-11.

The drawer is open.

Close the drawer.

There is a poor connection

Check all internal connectors.

There is a paper jam.

Remove the paper and reinstall correctly.

The recorder motor cable is disconnected.

Ensure that the recorder motor cable is properly connected to the recorder board.

The recorder motor malfunctioned.

Replace the thermal print head. See "Removing the Thermal Printer Head" on page 5-11.

The paper is installed incorrectly (the wrong side of the paper is facing up).

Load the paper correctly.

The thermal printhead is disconnected.

Ensure that the thermal printhead cable is properly connected to the recorder board.

The thermal printhead malfunctioned.

Replace the recorder board. See "Removing the Recorder Board" on page 5-7.

The paper settings is incorrect.

Set the correct paper settings.

There is no paper transport

The recorder runs normally, but the paper remains blank, or contains blurry or incorrect traces.

4.9 Performance Verification Testing After repairing the monitor, you should perform verification testing. See "Performance Verification Tests" on page 2-3 and "Safety Tests" on page 2-8.

4-6

CTG7 Fetal/Maternal Monitor Service Guide

5 Repairing the CTG7 Fetal/Maternal Monitor This chapter describes the procedures for disassembling and assembling the CTG7 Fetal/Maternal monitor in order to replace or repair defective assemblies/components. The CTG7 Fetal/Maternal monitor includes the top cover assembly and the bottom housing assembly.

5.1 Required Tools The following lists the tools required to disassemble, repair, and re-assemble the CTG7 Fetal/Maternal monitor:

Warning

•

Phillips head driver 3mm

•

Flat-head screwdriver

•

Hexagon nut driver 3mm

•

Wire cutter

•

Long-nosed pliers

•

Tweezers

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.

5.2 Removing/Replacing the Battery Before performing any service on the monitor, you should remove the battery. To remove the battery: 1. Carefully place the monitor upside down on a soft surface.

CTG7 Fetal/Meternal Monitor Service Guide

5-1

Removing/Replacing the Battery

2. Use a flat-head screwdriver to open the battery cover.

3. Press the spring lock down to release the battery.

4. Pull out the battery.

5-2

CTG7 Fetal/Meternal Monitor Service Guide

Removing/Replacing the Battery

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.

5.2.1 Battery Maintenance and Disposal When the battery displays signs of damage or when it no longer charges, replace it. Dispose of the used battery in accordance with local laws and regulations.

5.2.2 Reconditioning the Battery Caution

Only authorized service representatives should recondition the battery. 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.

CTG7 Fetal/Meternal Monitor Service Guide

5-3

Removing/Replacing the Fuse

5.3 Removing/Replacing the Fuse To remove a fuse in AC power socket: 1. Use a flat-head screwdriver to lift the fuse holder away from AC power socket.

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.

5-4

CTG7 Fetal/Meternal Monitor Service Guide

Separating the Top Cover Assembly and the Bottom Housing Assembly

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.

4. Gently open the top cover assembly.

System Board Connector Cable

CTG7 Fetal/Meternal Monitor Service Guide

5-5

Disassembling the Top Cover Assembly

5. Remove the system board connector cable to separate the top cover assembly from the bottom housing assembly.

Bottom Housing Assembly

Top Cover Assembly

5.5 Disassembling the Top Cover Assembly To disassemble the top cover assembly, you must remove these components: •

Recorder board

•

Thermal printer head assembly

•

Print keypad

•

Navigation wheel board

•

LCD display assembly – LCD screen – LCD drive module – Alarm LED board Recorder Board

Metal Bar A

Metal Bar B

LCD Display Assembly

Print Keypad Navigation Wheel Board Thermal Printer Head Assembly

Printer Key

5-6

Navigation Wheel

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

5.5.1 Removing the Recorder Board To remove the recorder board: 1. Remove the two screws shown and remove the metal bar A.

Metal Bar A 2. Remove all connecter cables as shown.

3. Remove three M3x6 screws.

4. Remove the recorder board.

CTG7 Fetal/Meternal Monitor Service Guide

5-7

Disassembling the Top Cover Assembly

5.5.2 Installing the Recorder Board To install the recorder board: 1. Put the screw bolt into the fixing groove and place the recorder board 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.

LCD Drive Cable

4. Put the metal A as shown.

5-8

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

5. Use Hexagon nut driver to install the nut. Install the M3x6 screw on the rest corner of the recorder board as shown.

6. Use Hexagon nut driver to tighten the nut as shown.

7. Connect all cables as shown.

CTG7 Fetal/Meternal Monitor Service Guide

5-9

Disassembling the Top Cover Assembly

5.5.3 Removing the Print Keypad To remove the print keypad: 1. Remove the three screws and remove the metal bar B.

Metal Bar B

2. Remove the navigation wheel cable and the six M3x8 screws. Navigation Wheel Cable

3. Remove the print keypad.

4. Remove the plastic pad.

5-10

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

5.5.4 Removing the Thermal Printer Head To remove the thermal print head: 1. Remove four 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.

5.5.5 Removing the Printer Door To remove the printer door: 1. Hold the printer door as shown and push the plastic shell in the direction as shown.

Push the Plastic Shell

CTG7 Fetal/Meternal Monitor Service Guide

5-11

Disassembling the Top Cover Assembly

2. Pull out one side of the printer door in the direction as shown.

Pull out the Printer Door 3. Remove the printer door.

Printer Door

5.5.6 Removing the Compaction Paper Pane To remove the compaction paper pane: 1. Hold the compaction paper pane and insert flat head screwdriver into the slot on the right side of the compaction paper pane. 2. Push the compaction paper pane in the direction as shown. Press the compaction paper pane down.

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.

5-12

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

4. Note the spring on the left side of the compaction paper pane.

Spring on A Side

A Side

B Side

Spring

5.5.7 Installing the Compaction Paper Pane To install the compaction paper pane: 1. Check the Spring and the compaction paper pane.

Long Side

Short Side

Hole on A Side

2. Insert the short side of the spring through the hole on the compaction paper pane.

CTG7 Fetal/Meternal Monitor Service Guide

5-13

Disassembling the Top Cover Assembly

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

5.5.8 Removing the Navigation Wheel Board To remove the navigation wheel board: 1. Remove the navigation wheel cap.

Pull upright

2. Use a long-nosed pliers to remove the screw.

5-14

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

3. Remove the navigation wheel board.

Navigation Wheel Cable

5.5.9 Removing the LCD Display Assembly The LCD display assembly contains three main components: •

LCD screen

•

LCD drive module

•

Alarm LED board

To remove the LCD display assembly: 1. Turn over the top cover assembly.

2. Press the Lock button to release the LCD display assembly. LCD Lock Button

3. Lift the LCD screen . You will find two plastic covers at the bottom of the two sides of the LCD screen.

Plastic Caps

CTG7 Fetal/Meternal Monitor Service Guide

5-15

Disassembling the Top Cover Assembly

4. Unveil the two plastic caps. Use a flat-head screwdriver.

Left Side

Right Side

5. Remove four M3x4 screws.

6. Separate the LCD display assembly from the top cover assembly.

7. Remove the two plastic caps.

5-16

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

5.5.9.1 Removing the LCD Drive Module and the LCD Screen To remove the LCD board: 1. Remove four plastic covers and the four M3x6 screws and remove the back shell.

2. Remove the alarm LED cable, LCD display cable, and LCD drive cable. Alarm LED Cable

CTG7 Fetal/Meternal Monitor Service Guide

LCD Display Cable

LCD Drive Cable

5-17

Disassembling the Top Cover Assembly

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

5.5.9.2 Removing the Alarm LED Board To remove the alarm LED board: 1. Remove the two M3x6 screws and remove the alarm LED cable. Remove the alarm LED board.

Alarm LED Cable 2. LCD Upper Panel. LCD Upper Panel

5-18

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Top Cover Assembly

5.5.9.3 Removing the LCD Lock Button To remove the LCD lock button: 1. Use the flat head screw driver to loosen the clips and push the LCD lock button upward very carefully. Note the springs installed in the holes as shown.

Step 2: Push upward

Step 1: Loose clips

2. Remove the LCD lock button.

Lock Button Springs

LCD Lower Panel

5.5.9.4 Installing the LCD Lock Button To install the LCD lock button: 1. Insert the LCD lock button into the clips and install two springs into the holes as shown.

CTG7 Fetal/Meternal Monitor Service Guide

5-19

Disassembling the Bottom Housing Assembly

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.

5.6 Disassembling the Bottom Housing Assembly To disassemble the bottom housing assembly, you must remove these components:

5-20

•

Transducer holder

•

SpO2 module

•

Fetal monitoring (FM) module

•

Socket panel

•

System board

•

NIBP module

•

Speaker CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Bottom Housing Assembly

•

ECG module

•

AC/DC power module

•

Power socket

•

Interface board

•

Battery charge board

Interface Board

Power Socket System Board

NIBP Module Transducer Holder

AC/DC Power Module SpO2 Module

Speaker ECG Module Fetal Monitoring (FM) Module

Probe Socket

5.6.1 Removing the Transducer Holder To remove the probe bracket: 1. Remove three M3x6 screws.

2. Remove the probe bracket.

CTG7 Fetal/Meternal Monitor Service Guide

5-21

Disassembling the Bottom Housing Assembly

5.6.2 Removing the SpO2 Module To remove the SpO2 module: 1. Remove two M3 x 6 screws.

2. Gently unplug the SpO2 board from the system board. Note the connector pins between the SpO2 board and the system board.

5.6.3 Removing the Fetal Monitoring (FM) Module To remove the fetal monitoring (FM) module: 1. Remove four M3x6 screws and two connector cables. FM Cable

Speaker Connector Cable

5-22

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Bottom Housing Assembly

2. Remove the four connector plastic nuts.

3. Unplug the socket panel.

4. Unplug the FM board.

5.6.4 Removing the System Board To remove the system board: 1. Unplug all the connector cables.

NIBP Cable Netport Cable ECG Cable Power Cable

FM Cable SpO2 Cable

CTG7 Fetal/Meternal Monitor Service Guide

5-23

Disassembling the Bottom Housing Assembly

2. Remove the six M3x6 screws.

3. Remove the system board and the plastic sheet.

System Board Insulation Plastic Sheet

5.6.5 Removing the NIBP Module To remove the NIBP module: 1. Remove the cable tie and remove the four M3x6 screws.

5-24

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Bottom Housing Assembly

2. Remove the NIBP connector tube. Note the tube connection.

3. Remove the NIBP module.

5.6.6 Removing the Speaker To remove the speaker: 1. Remove the three M3x6 screws and remove the speaker assembly.

CTG7 Fetal/Meternal Monitor Service Guide

5-25

Disassembling the Bottom Housing Assembly

5.6.7 Removing the ECG Module To remove the ECG module: 1. Remove the cable tie.

2. Remove three M3x6 screws.

ECG Cable (To System Board)

ECG Cable (To ECG Probe)

3. Remove the ECG board.

5-26

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Bottom Housing Assembly

5.6.8 Removing the AC/DC Power Module To remove the AC/DC power module: 1. Unplug the power cable and remove the four M3x6 screws (yellow circles).

Power Cable

2. Remove the AC/DC power module.

5.6.9 Removing the Interface Board To remove the interface board: 1. Remove the three M3x6 screws and the ground wire.

Electric Foam (5 x 8 x 63 mm) Ground Wire

2. Remove the interface board.

CTG7 Fetal/Meternal Monitor Service Guide

5-27

Disassembling the Bottom Housing Assembly

5.6.10 Removing the Power Socket To remove the power socket: 1. Remove two M3x8 screws with washers and remove the power socket.

Electric Foam (8 x 8 x 63 mm)

5.6.11 Removing the Probe Socket and NIBP Socket To remove the probe socket: 1. Remove the ECG and SpO2 connector cable.

ECG Connector Cable

SpO2 Connector Cable

2. Remove the probe socket.

3. Remove two M3x6 screws.

5-28

CTG7 Fetal/Meternal Monitor Service Guide

Disassembling the Bottom Housing Assembly

4. Remove the NIBP socket.

5.6.12 Removing the Battery Charger Board To remove the battery charger board: 1. Remove six M3x6 screws to remove the metal plate A.

Plate A 2. Remove eight M3x6 screws.

CTG7 Fetal/Meternal Monitor Service Guide

5-29

Disassembling the Bottom Housing Assembly

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. Remove two M3x6 screws.

5. Remove the battery charger board.

5-30

CTG7 Fetal/Meternal Monitor Service Guide

6 Replacement Parts and Assembly Drawings This chapter contains the assembly diagrams and describes the replaceable parts of the CTG7 Fetal/ Maternal Monitor.

6.1 CTG7 Main Assembly Exploded Diagram

1

2

3

Figure 6-1 CTG7 Main Assembly Exploded Diagram

Table 6-1 CTG7 Main Assembly Exploded Diagram List

Item

Descriptions

P/N

1

LCD display assembly

N/A

2

Top cover assembly

N/A

3

Bottom housing assembly

N/A

CTG7 Fetal/Maternal Monitor Service Guide

6-1

CTG7 LCD Display Assembly and Parts

6.2 CTG7 LCD Display Assembly and Parts 1

2

3 4 5

6

7

Figure 6-2 CTG7 LCD Display Assembly Exploded Diagram

Table 6-2 CTG7 LCD Display Assembly Parts List

Item

6-2

Descriptions

P/N

1

3T PLAST LCD Key (LCD Lock Button)

453564286051

2

3T PLAST LCD Lower Panel

453564277331

3

PCA 3T CTG7DRV00 V1.4 Pb Free (LCD drive module)

453564337391

4

3T INSUL Insulation Film PVC (LCD insulation plastic sheet)

453564278611

5

DSPL 7'' TFT Display CHIMEI (TFT LCD screen)

453564336431

6

3T PCA Alarm Board AL00 V1.1 (Alarm LED board)

453564304431

7

3T PLAST LCD Upper Panel

453564277321

CTG7 Fetal/Maternal Monitor Service Guide

CTG7 Top Cover Assembly and Parts

6.3 CTG7 Top Cover Assembly and Parts

1 2 3 4 5 6 10

7 8

9

Figure 6-3 CTG7 Top Cover Assembly Exploded Diagram

Table 6-3 CTG7 Top Cover Assembly Parts List

Item

Description

P/N

1

3T PLAST Headrace Panel

453564278421

2

3T PCA Printer Drive Board PRT00 V1.1 (Recorder board)

453564304471

3

PTR Thermal Recorder (Thermal printer head assembly)

453564294041

4

3T PCA Key Board KE00 V1.1 (Print keypad)

453564304461

5

3T PLAST Compaction Paper Pane

453564277361

6

3T ASSY Front Frame

453564390351

7

3T PLAST Printer Button

453564278371

8

3T PLAST Printer Door

453564277341

9

3T PLAST Button (Navigation Wheel Button)

453564278391

10

PCA Code Board C-DOCE011D (Navigation wheel board)

453564297371

CTG7 Fetal/Maternal Monitor Service Guide

6-3

CTG7 Bottom Housing Assembly and Parts

6.4 CTG7 Bottom Housing Assembly and Parts 14

1 2

12 11

10 3 4

13 9

5 15 7 6

8

Figure 6-4 CTG7 Bottom Housing Assembly Exploded Diagram

Table 6-4 CTG7 Bottom Housing Assembly Parts List

Item 1

6-4

Description

P/N

PCA 4ACN00 V1.4 Pb Free (Interface board)

453564304331

PCA Interface Board CN00 V1.1 (Interface board)

453564304521

2

PCA NIBP Module Assembly C-NIBP312B (NIBP Module)

453564288791

3

3T ASSY Speaker (Alarm speaker)

453564390361

4

CTG7 PCA FM00 (Fetal monitoring module)

453564280241

5

3T PLAST Fixing Inductor (Transducer holder)

N/A

6

3T Function INTFC ASSY, SpO2/NIBP (Probe socket, SpO2/NIBP)

453564304371

3T Function INTFC ASSY, SpO2/NIBP/ECG (Probe socket, SpO2/ NIBP/ECG)

453564304381

7

PCA EECG Module C-ECG7131C V1.2 (ECG module)

453564304531

8

3T ASSY Rear Frame

453564390341

CTG7 Fetal/Maternal Monitor Service Guide

Sparts Parts List

Table 6-4 CTG7 Bottom Housing Assembly Parts List

Item

Description

P/N

9

ASSY-PWR SMPS LPS54-M (AC/DC power module)

453564288691

10

3T ASSY Power Socket (Power socket)

453564390371

11

3T PCA System Board SYS00 V1.1 (System board)

453564304501

12

PCA SPO2 GISP-N C-ISPO2011B Pb Free (SpO2 module)

453564290991

13

PCA BAT Adapte Board CHG00 V1.3 Pb Free (Battery charger board)

453564304511

14

3T PLAST Interface Film 2 Hole (Interface film)

453564293981

3T PLAST Interface Panel Film (Interface film, single hole)

453564278551

3T INSUL System Board Film PVC (System board insulation plastic sheet)

453564278601

15

6.5 Sparts Parts List

Table 6-5 CTG7 Spare Parts List

Item

Descriptions

P/N

1

3T PLAST LCD Key (LCD Lock Button)

453564286051

2

3T PLAST LCD Lower Panel

453564277331

3

PCA 3T CTG7DRV00 V1.4 Pb Free (LCD drive module)

453564337391

4

3T INSUL Insulation Film PVC (LCD insulation plastic sheet)

453564278611

5

DSPL 7'' TFT Display CHIMEI (TFT LCD screen)

453564336431

6

3T PCA Alarm Board AL00 V1.1 (Alarm LED board)

453564304431

7

3T PLAST LCD Upper Panel

453564277321

8

3T PLAST Headrace Panel

453564278421

9

3T PCA Printer Drive Board PRT00 V1.1 (Recorder board)

453564304471

10

PTR Thermal Recorder (Thermal printer head assembly)

453564294041

11

3T PCA Key Board KE00 V1.1 (Print keypad)

453564304461

12

3T PLAST Compaction Paper Pane

453564277361

13

3T ASSY Front Frame

453564390351

14

3T PLAST Printer Button

453564278371

15

3T PLAST Printer Door

453564277341

16

3T PLAST Button (Navigation Wheel Button)

453564278391

17

PCA Code Board C-DOCE011D (Navigation wheel board)

453564297371

CTG7 Fetal/Maternal Monitor Service Guide

6-5

Sparts Parts List

Table 6-5 CTG7 Spare Parts List

Item

6-6

Descriptions

P/N

18

3T PLAST Headrace Panel

453564278421

19

PCA 4ACN00 V1.4 Pb Free (Interface board)

453564304331

PCA Interface Board CN00 V1.1 (Interface board)

453564304521

20

PCA NIBP Module Assembly C-NIBP312B (NIBP Module)

453564288791

21

3T ASSY Speaker (Alarm speaker)

453564390361

22

CTG7 PCA FM00 (Fetal monitoring module)

453564280241

23

3T Function INTFC ASSY, SpO2/NIBP (Probe socket, SpO2/ NIBP)

453564304371

3T Function INTFC ASSY, SpO2/NIBP/ECG (Probe socket, SpO2/NIBP/ECG)

453564304381

24

PCA EECG Module C-ECG7131C V1.2 (ECG module)

453564304531

25

3T ASSY Rear Frame

453564390341

26

ASSY-PWR SMPS LPS54-M (AC/DC power module)

453564288691

27

3T ASSY Power Socket (Power socket)

453564390371

28

3T PCA System Board SYS00 V1.1 (System board)

453564304501

29

PCA SPO2 GISP-N C-ISPO2011B Pb Free (SpO2 module)

453564290991

30

PCA BAT Adapte Board CHG00 V1.3 Pb Free (Battery charger board)

453564304511

31

3T PLAST Interface Film 2 Hole (Interface film)

453564293981

3T PLAST Interface Film (Interface film, single hole)

453564278551

32

3T INSUL System Board Film PVC (System board insulation plastic sheet)

453564278601

33

Fetal Waker device

989803174951

34

CBL 2x8PIN, 2.0, 120mm (keypad board and printer dirve board connector cable)

453564311721

35

UT-4B CBL Encode Connection (Navigation wheel cable)

453564311521

36

CBL 8PIN Conversion 10PIN 2.0 L180mm (SpO2 Cable)

453564278761

37

3T CBL 4PIN, 1.25, L50mm (Alarm LED cable)

453564278781

38

3T CBL FFC 26PIN, 0.5, 80mm (LCD drive cable)

453564280821

39

3T CBL 2x15PIN, 2.0, L190mm (System Board Connector Cable)

453564278751

40

3T CBL 5PIN, 2.54, L110mm (FM cable and Netport cable)

453564278811

41

3T CBL 7PIN, 2.54, L90mm (NIBP cable)

453564278771

42

3T CBL 2PIN, 3.96, L70mm (Power cable)

453564278801

43

CBL 6PIN Conversion 4PIN 2.54 L70mm (ECG cable)

453564278821

CTG7 Fetal/Maternal Monitor Service Guide

Sparts Parts List

Table 6-5 CTG7 Spare Parts List

Item 44

Descriptions UT-4B CBL SPO2 Socket Connection, 7 PIN

CTG7 Fetal/Maternal Monitor Service Guide

P/N 453564311531

6-7

Sparts Parts List

6-8

CTG7 Fetal/Maternal Monitor Service Guide

7 Electromagnetic Compatibility This chapter lists the tests and compliance levels that make the CTG7 Fetal/Maternal monitor suitable for use in the specified electromagnetic environment according to IEC 60601-1-2:2007.

7.1 Instructions for Use Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC60601-1-2:2007, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2007. Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your service provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in this service guide.

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.

CTG7 Fetal/Maternal Monitor Service Guide

7-1

Guidance and Manufacturer's EMC Declaration

7.2 Guidance and Manufacturer's EMC Declaration The CTG7 Fetal/Maternal monitor is intended for use in the electromagnetic environment specified in the following tables. The customer or the user of the CTG7 monitor should assure that it is used in such an environment.

7.2.1 Electromagnetic Emissions for all Equipment and Systems Table 7-1 Electromagnetic Emissions for all Equipment and Systems

Emission test

Compliance

Electromagnetic Environment Guidance

RF emissions

Group 1

The CTG7 Fetal/Maternal monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

The CTG7 Fetal/Maternal monitor is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11

RF emission CISPR 11 Harmonic emissions

Class A

IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

7.2.2 Electromagnetic Immunity for all Equipment and Systems Table 7-2 Electromagnetic Immunity for all Equipment and Systems

Immunity Test Electrostatic discharge (ESD)

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

±6KV contact

±6KV contact

±8KV air

±8KV air

Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.

±2KV for power supply lines

±2KV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

±1KV differential mode

±1KV differential mode

Mains power quality should be that of a typical commercial or hospital environment.

±2KV common mode

±2KV common mode

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

7-2

CTG7 Fetal/Maternal Monitor Service Guide

Guidance and Manufacturer's EMC Declaration

Table 7-2 Electromagnetic Immunity for all Equipment and Systems (Continued)

Immunity Test Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/ 60Hz) magnetic field

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

95% dip in UT) for 0.5 cycle

95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the CTG7 Fetal/Maternal monitor requires continued operation during power mains interruptions. It is recommended that the CTG7 Fetal/Maternal monitor be powered from an uninterruptible power supply or a battery.

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

95% dip in UT) for 5 sec

95% dip in UT) for 5 sec

3A/m

3A/m

Mains power quality should be that of a typical commercial or hospital environment.

IEC61000-4-8 1. UT is the AC mains voltage prior to application of the test level.

CTG7 Fetal/Maternal Monitor Service Guide

7-3

Guidance and Manufacturer's EMC Declaration

7.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting Table 7-3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting

Immunity Test

IEC60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance Portable and mobile RF communications equipment should be used no closer to any part of the CTG7 Fetal/Maternal monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

1 Vrms

3 V/m

 3 .5  d   P  V1 

3.5 d = ------E1

P

7 d   P  E1 

80 MHz to 800 MHz

800 MHz to 2.5 GHz

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,1 should be less than the compliance level in each frequency range.2 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 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 necessary, 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.

7-4

CTG7 Fetal/Maternal Monitor Service Guide

Guidance and Manufacturer's EMC Declaration

7.2.4 Recommended Separation Distances The CTG7 Fetal/Maternal monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CTG7 Fetal/Maternal monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CTG7 Fetal/Maternal monitor as recommended below, according to the maximum output power of the communications equipment. Table 7-4 Recommended Separation Distances Between Portable and Mobile RF

Communications Equipment and CTG7 Fetal/Maternal Monitor

Separation Distance According to Frequency of Transmitter (m) 1 Rated Maximum Output Power Of Transmitter (W)

150 kHz to 80 MHz

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

 3 .5  d   P  V1 

80 MHz to 800 MHz

3.5 d = ------E1

P

800 MHz to 2.5 GHz

7 d = ----E1

P

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.

CTG7 Fetal/Maternal Monitor Service Guide

7-5

Guidance and Manufacturer's EMC Declaration

7-6

CTG7 Fetal/Maternal Monitor Service Guide

Index battery reconditioning, 5-3 battery removing and replacing, 5-1 fuse removing and replacing, 5-4 required tools, 5-1 top cover disassembling, 5-6 separating, 5-4

D demo mode configuring, 1-5 returning to regular monitoring, 1-5 diagram bottom housing, 6-4 LCD display assembly, 6-2 main assembly, 6-1 top cover assembly, 6-3

E electromagnetic compatibility instructions for use, 7-1 EMC instructions for use, 7-1

M manufacture responsibilities, 2-1

P product configuration table, 1-4 electromagnetic compatibility, 7-1 electromagnetic emissions all, 7-2 electromagnetic immunity all, 7-2 not life-supporting, 7-4 hardware overview, 3-1 main components, 1-4 mounting, 1-6 overview, 1-2 spare parts list, 6-5 product information manufacturer, i-ii product warranty, i-v product, electromagnetic compatibility separation distance, 7-5

R regulatory and safety specifications, i-v repair strategy, 1-1 repairing battery maintenance, 5-3

UT3000 Fetal/Maternal Monitor Service Guide

repairing, bottom housing AC/DC power module removing, 5-27 battery charger board removing, 5-29 disassembling, 5-20 ECG module removing, 5-26 fetal monitoring module removing, 5-22 I/O interface board removing, 5-27 NIBP module removing, 5-24 NIBP socket removing, 5-28 power socket removing, 5-28 probe socket removing, 5-28 speaker removing, 5-25 SpO2 module removing, 5-22 system board removing, 5-23 transducer holder removing, 5-21 repairing, front panel alarm LED board, 5-18 repairing, top cover LCD display, 5-15 navigation wheel board removing, 5-14 printer key board removing, 5-10 recorder board removing, 5-7 thermal printer head removing, 5-11 reparing, top cover alarm LED board removing, 5-18 LCD drive module removing, 5-17 LCD screen removing, 5-17 replace accessories, 1-1 parts, 1-1

S safety specification, i-v safety standards, i-vi site requirements enviromental, 1-2 space, 1-2

Index-1

software upgrade USB-RS232, 2-12 upgrading, 2-12 software, data file updating, 2-20 software, hyper terminal creating, 2-15 software, language setting, 2-24 software, language resource file updating, 2-21

theory ECG, 3-3 fetal monitoring, 3-3 fetal recorder, 3-2 board, 3-2 thermal printer head, 3-2 I/O interface board, 3-3 LCD display, 3-2 NIBP, 3-2 power supply, 3-2 SpO2, 3-3 system module, 3-3

symbols, on monitor and packaging, i-iii

troubleshooting alarm, 4-2 display, 4-2 ECG, 4-5 fetal monitoring, 4-3 NIBP, 4-4 performance tests, 4-6 power, 4-1 recorder, 4-6 SpO2, 4-5

T

U

test fetal recorder maintenance, 2-11 frequency, 2-2 guidelines, 2-1 performance tests, 2-3 ECG, 2-7 fetal monitoring, 2-4 NIBP, 2-4 NIBP accuracy, 2-5 NIBP calibration, 2-6 NIBP leakage, 2-6 NIBP linearity, 2-6 NIBP overpressure, 2-7 power supply and battery, 2-4 pulse SpO2, 2-7 speaker, 2-12 visual, 2-4 recorder, 2-12 recording, 2-3 required equipment, 2-2 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

UT 3000 monitor visual inspection, 2-1

software, program file updating, 2-17 specifications environmental, 1-2 power, 1-3 symbols, i-iii

Index-2

UT3000 monitor back cover exploded diagram, 6-3 main frame exploded diagram, 6-3 UT3000 monitor, performance tests NIBP, 2-7 calibartion, 2-5 power supply and battery, 2-4 UT3000 monitor, test required equipment, 2-2 UT3000 monitor, troubleshooting performace tests, 4-5, 4-6 UT3000, test performance tests fetal monitoring, 2-4

CTG7 Fetal/Maternal Monitor Service Guide

Printed in China Third Edition

*13307021009* 453564293951

3.0 3.0