Gima TLC5000 Parts list manual

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
[e-mail] - [e-mail]
www.gimaitaly.com
0123
0%
%
-40˚C
+55˚C
86kPa
106kPa

I
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:

I
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.

I
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.
The user manual is written by Contec Medical Systems Co., Ltd. All rights reserved.

IV
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

V
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

1
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.

2
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

3
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

4
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

5
Medical Device compliant with Directive 93/42/EEC
Authorized representative in the European community
Manufacturer
Date of manufacture
Temperature limit
Humidity limit
Atmospheric pressure limit
Keep in a cool, dry place
Keep away from sunlight
Fragile, handle with care

6
This side up Imported by
Product code Lot number
1.4 Maintenance and Cleaning
It is recommended that you check if there is any damage on the recorder or leads wires before
monitoring on the patient. If you find any damage, stop using it, and contact the biomedical
engineer of the hospital or our Customer Service immediately.
In addition, the overall check of the recorder, including the safety check, should be performed
only by qualified personnel once every 12 months.
The recorder can be cleaned with hospital-grade ethanol and dried in air or with dry and clean
cloth.
Please take out the batteries if the recorder is not in use for a long time and proper safekeeping.

7
Chapter 2 Frame Character of Product
2.1 Sketch Map for every Orientation
2.1.1 Front view
Fig.2-1 Front view

8
2.1.2Side view
Fig.2-2 Side view
2.1.3Bottom view
Fig.2-3 Bottom view

9
2.2 Definition of Keystoke, Interface and Indicator Light
function key: marker/affirmance/choice
function key: menu/cancel/turn on/off
direction key: left
direction key: right
direction key: go up
direction key: go down
Indicator light: (glint every 4 seconds when collecting ECG signal)
Show date communication status when connecting with the computer.

1
Chapter 3 Preparing Work before Using
3.1 Electrode Placement
Notice:
The placement of electrode is the basic of holter recorder collecting ECG data signal. The
quality and position of electrode affect the quality of ECG signal. Please read this chapter
carefully before first operation.
The conductive part (applied part) of electrode should not contact with other conductive
parts or the earth.
Signal input/output part can be connected with the specified instrument only, please
contact our company for any replacement.
Position of the electrode placement is shown (as Fig.3-1).
Fig.3-1

1
Deal with the skin
When attaching and placing the electrode, we need to deal with the skin at first, and be sure to
clean the skin. Use 95 % alcohol to scrub the skin, after the alcohol evaporates, use abrasive
paper attached to the electrode to wipe the attached place to remove cuticula on the surface of the
skin in order to reduce the resistance from the skin and the disturbance from the EMG. People
who have much hair need to shave it to ensure the skin well connected with the electrode. The
skin of old patients is dry and has many crinkles, so we have to clean the skin and make the
attached place flat. If the attached place is near the bosom of the woman patient, electrode and
cables should be covered by the bra and then fixed well.
Place the electrode
Use high-quality ECG electrode to attach the right place and connect with the correspond
electrode. To prevent the electrode drop and the baseline excursion caused by pulling, use the
medical adhesive belt or plaster to fix every electrode and cable properly. After the cables get
together, use the adhesive belt to fix in the abdomen; the rest cables can be tucked into the
recorder's waistband. Don't use the common adhesive belt to attach the cables for fear of dirtying,
corroding the cables and reducing the usage life span. If use the device in the environment of
high temperature or easy perspiring, "EKG Medical Gel" could be wiped on the skin around the
electrode beforehand.

1
3.2 Battery Installation and Notice
3.2.1 Open the battery cover according to the direction which the arrowhead on the cover
indicates. Follow as Fig.3-2.
Fig.3-2
3.2.2 Please insert the batteries properly in the right direction, and then close the cover. Follow
as Fig.3-3.
Fig.3-3

1
3.2.3 The state of battery and working requirements are shown as Table 3-a1.
The batteries are full, the device could run in gear.
The batteries are insufficient, suggest not record.
The batteries are almost drained, please replace the battery immediately.
Table 3-a1
When the batteries are almost drained and not replaced, the recorder will show the interface (as
Fig.3-4), and turn into protected mode.
Fig.3-4
When the energy of battery is low, the recorder turn into protected mode in order to protect the

1
recorder from damaging. Under protected mode the device don't run until the device is
electricized by USB or the batteries are full.
Warning:
The batteries should be full when the device collects new information, otherwise the
recording time could not last long enough.
Notice:
Please confirm all electrodes and lead wires are connected well to patient. Otherwise,
interference in waveform at the beginning of record may lead to failure analysis.
Notice:
Please take off the battery after monitoring in order to protect the recorder from damaging
because of battery leak.
Instructions:
The electrode indicator and pictures in this direction take example for usually American, if there
is some difference in the actual use,please operate and use refer to following usually European
indicator.
LA LL V1 V3 V5
RA RL V2 V4 V6
3-5 usually American 3-6 usually European