Gima TLC5000 Stücklistenhandbuch

M35130-EN-Rev.2-01.24

PROFESSIONAL MEDICAL PRODUCTS

ECG HOLTER WITH SOFTWARE

Use and maintenance book

TLC5000 (GIMA 35130)

CONTEC MEDICAL SYSTEMS CO., LTD

No.112 Qinhuang West Street, Economic & Technical

Development Zone, Qinhuangdao, Hebei Province,

PEOPLE’S REPUBLIC OF CHINA

Made in China

Prolinx GmbH Brehmstr. 56, 40239,

Duesseldorf, Germany

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

0123

-40˚C

+55˚C

86kPa

106kPa

Foreword

Please read the User Manual carefully before using this product. The operating procedures

specifies in this User Manual should be followed strictly. This manual describes in detail the

operation steps must be noted, the procedures may result in abnormal, and possible damage to

the product or users, refer to following chapters for details. Failed to follow the User Manual

may cause measuring abnormality, device damage and personal injury. The manufacturer is NOT

responsible for the safety, reliability and performance issues of such results due to user’s

negligence of this manual for using, maintenance or storage. The free services and repairs does

not cover such faults either.

The content in this user manual complies with real product. For software upgrade and some

modifications, the content in this user manual is subject to change without prior notice, and we

sincerely apologize for that.

Note: Please read the user manual carefully before use, and operate the device strictly

following the procedures in the user manual.

Warnings

Before using this product, the safety and effectiveness described in the following shall be

considered:

Type of protection against electric shock: internally powered equipment.

Degree of protection against electric shock: type BF applied part.

Working mode: continuous operating device.

Protection classification of shell: IP22.

Measurement results shall be described by qualified doctors combined with clinical

symptoms.

The using reliability depends on whether the operation guide and maintenance instructions

in this manual is followed.

The device is not applicable for infants weighting less than 10Kg.

Contraindications: none.

The device can not work directly on human heart.

Date of manufacture: see the label.

Warning: To ensure safety and effectiveness, please use the accessories recommended

by our company. Repair and maintenance shall be carried out by professional personnel

approved by our company. Replacement of accessories that are not supplied by our

company may result in errors. Any maintenance personnel who has not been trained by our

company or other authorized service organization should not attempt to maintain the

product.

Responsibility of operator

The device should be operated by a professionally trained medical staff, and kept by a

special person.

The operator must carefully read the User Manual before using this product, and strictly

follow the operating procedure described in the User Manual.

The safety requirements have been fully considered in product designing, but the operator

should not ignore the observation on patient and the state of device.

The operator shall provide the use condition of the product to our company.

Responsibility of our company

Our company supplies qualified products to users.

Our company provides services of installation, debugging and technically training

according to the contract.

Our company performs device repair in warranty period (one year) and maintenance after

warranty period.

Our company is responsible to respond to users' requirements in time.

CONTENTS

Chapter 1 Introduction ............................................................................................................... 1

1.1 Environment Condition ............................................................................................. 1

1.2 Product Feature.......................................................................................................... 1

1.3 Safety......................................................................................................................... 2

1.4 Maintenance and Cleaning......................................................................................... 6

Chapter 2 Frame Character of Product....................................................................................... 7

2.1 Sketch Map for every Orientation.............................................................................. 7

2.2 Definition of Keystoke, Interface and Indicator Light ............................................... 9

Chapter 3 Preparing Work before Using .................................................................................. 10

3.1 Electrode Placement ................................................................................................ 10

3.2 Battery Installation and Notice ................................................................................ 12

Chapter 4 Recorder Operation Explanation ............................................................................. 16

4.1 New Record............................................................................................................. 17

4.2 Review Record ........................................................................................................ 20

4.3 System Set ............................................................................................................... 22

4.4 Replay Record ......................................................................................................... 27

Chapter 5 Malfunction Analysis and Troubleshooting ............................................................. 30

5.1 Daily Maintenance................................................................................................... 30

5.2The Problem Related to the Battery......................................................................... 31

5.3The Problem Related to the Skin and the Electrode................................................. 33

5.4The Problem Related to the Cable and the Input Plug ............................................. 34

5.5Other Problems........................................................................................................ 35

Chapter 6 Instructions for Analysis Software........................................................................... 36

Appendix Ⅰ................................................................................................................................ 131

Appendix II............................................................................................................................... 133

Appendix III Guidance and Manufacture's Declaration ......................................................... 135

Appendix IV Accuracy of Operating Data............................................................................. 140

Appendix V Warranty ............................................................................................................ 141

Chapter 1 Introduction

1.1 Environment Condition

The environment requirement of operation, transport and storage for Dynamic ECG Systems:

Operation Environment:

Environment Temperature: 10 ℃~45 ℃

Relative Humidity: ≤85 %

Atmospheric Pressure: 86 kPa~106 kPa

Power Supply: DC 3 V

Transport and Storage Environment:

Environment Temperature: -40 ℃~+55 ℃

Relative Humidity: ≤85 %

Atmospheric Pressure: 86 kPa~106kPa

1.2 Product Feature

Dynamic ECG Systems contain recorder & analysis software. Recorder is an easy- to -use unit,

which collects 12-lead ECG waveform synchronously and records continuously for 24 hours. In

addition, it also reviews ECG waveform. It is easy for you to use analysis software which plays

back ECG waveform stored in ambulatory recorder and achieves kinds of analysis functions,

such as arrhythmia, HRVA, QTDA, TWA, etc.

1.3 Safety

The design of Dynamic ECG Systems accords with the international safety standard

IEC60601-2-47.

Warning:

Arbitrary modification to the device is forbidden.

Avoid strong vibration and shock when using or moving the device. Doctor must tell the

patient monitored by recorder not to do violent movement.

Turn off the device before cleaning and disinfection. Do not use sharp material to wipe the

screen.

Do not use the device under interference by high-power equipment, such as high voltage

cable, X ray, ultrasonic machine, MRI machine or electrotherapy machine, and keep it

away from mobile phone and other radiation source.

The device should not be used together with any defibrillation device.

Do not connect the device to both the human body and computer at the same time.

Do not remove the USB plug when the device is in turning on state.

The environment where the device to be used should be kept away from vibration, dust,

corrosive or combustible matter, and avoid from extreme temperature and humidity, and

do not use the device in a humid environment.

Maintenance and repair are not allowed during using the device.

Other equipment or network is forbidden to connect with the system except the signal

input/output part connected to the system accessories.

Materials of product accessories should comply with the biological compatibility

requirements.

The materials selected for the design and manufacture of the device shall meet its excepted

service life. Any corrosion, aging, mechanical wear or degradation of biological materials

caused by bacteria, plants, animals, etc. will not degrade the mechanical properties of the

device.

Avoid contact with water. Avoid using or storing the device in places where excessive air

pressure, humidity or temperature exceeds the specified standard, poor ventilation or

dusty.

NO modification of equipment.

Pay attention to battery’s positive and negative anodes when replacing.

Please use LR6 AA alkaline battery to ensure the normal work of device.

Dispose of packaging materials, waste batteries and end-of-life products in accordance with

local laws and regulations. User should perform proper treatment to the waste products

and materials according to the regulations and try to classify the waste for recycling.

The ST algorithm has tested for accuary of the ST segment data.The significance of the ST

segment changes needs to be determined by a clinician.

Type BF applied part

USB interface

WEEE disposal

Covering Protection rate

Serial number

Follow instructions for use

Caution: read instructions

(warnings) carefully

Dieses Handbuch passt für folgende Modelle

Inhaltsverzeichnis

Andere Gima Medizinische Geräte Handbücher

Gima

Gima SUPER VEGA BATTERY Bedienungsanleitung

Gima

Gima OXY 110 Bedienungsanleitung

Gima

Gima Cardio-A Stücklistenhandbuch

Gima

Gima 27500 Bedienungsanleitung

Gima

Gima Dallas Bedienungsanleitung

Gima

Gima 24402 Bedienungsanleitung

Gima

Gima MG8001-H Bedienungsanleitung

Gima

Gima 34088 Bedienungsanleitung

Gima

Gima Rescue LIFE Bedienungsanleitung

Gima

Gima 25953 Bedienungsanleitung

Gima

Gima 27351 Bedienungsanleitung

Gima

Gima 33261 Bedienungsanleitung

Gima

Gima OTOSCILLO Bedienungsanleitung

Gima

Gima 27793 Bedienungsanleitung

Gima

Gima 31108 Bedienungsanleitung

Gima

Gima OXY-0 CMS50Q1 Bedienungsanleitung

Gima

Gima 28180 Bedienungsanleitung

Gima

Gima 34056 Stücklistenhandbuch

Gima

Gima 28209 Bedienungsanleitung

Gima

Gima Sonoline C 29480 Bedienungsanleitung

Gima

Gima CARDIOPOCKET ECG Bedienungsanleitung

Gima

Gima 31107 Stücklistenhandbuch

Gima

Gima 27335 Stücklistenhandbuch

Gima

Gima 27363 Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung

Tobii Dynavox

Tobii Dynavox I-Series Bedienungsanleitung

S-Capepod

S-Capepod Evac Cocoon Bedienungsanleitung