3RAY Electronics ECG-3306G User manual

Digital Electrocardiograph
Operation Manual
for ECG-33 0 6 G /ECG-3312G
Guangzhou 3RAY Electronics Co., Ltd.
Date ： 20 13 - 03 - 26
File No. ： MNU- ECG 3312G -USR- Rev.A1

Digital E lectrocardiograph Operation Manual
Statement of the Manufacturer
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The company only considers itself responsible for any effects on safety, reliability and
performance of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out
by personnel authorized by the company, and the electrical installation of the relevant room
complies with safety standards.
Responsibility of User
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This product will perform in conformity with the description thereof contained in this
Operation Manual and accompanying labels and/or inserts, when assembled, operated,
maintained and repaired in accordance with the instructions provided. This product must be
checked periodically for it's safety and accuracy . A defective p roduct should not be used.
This product or any of its parts should not be repaired other than in accordance with
instructions provided by the trained personnel by the manufacturer .
WARNING ： The machine uses environmentally friendly packaging
materials, the machine and its accessories in the use of end of life can
return to the manufacturer for recycling; or are to be properly handled
to comply with local regulations.
Using Labels Guide
N ote
This label advises against certain actions or situations that could
damage equipment, produce inaccurate data, or invalidate a procedure.
W arning
This label advises against certain actions or situations that could result
in personal injury or death.
NOTE ： This device is not intended for home use.
WARNING ： This device is not intended for treatment.

Digital E lectrocardiograph Operation Manual
Contents
1 、 Safety Guidance .................................................................................................................................... 1
3 Structure & Function ........................................................................................................................... 4
3.1 、 Front Panel ................................................................................................................................. 4
3.2 、 LCD display ................................................................................................................................ 4
3.4 、 Control Keypad Panel .............................................................................................................. 5
3.5 、 Patient Cable Interface( DB15 ) .............................................................................................. 5
3.6 、 Analog I/O and UART Interface ( RJ11 ) ............................................................................ 5
3.7 、 USB /Host Interface ( Optional ) ............................................................................................ 6
3. 8 、 USB or LAN Interface ( USB/ RJ45,Optional ) ................................................................... 6
4 、 Operation Preparation ......................................................................................................................... 7
4.1 Power supply and grounding ................................................................................................. 7
4.2 Using Recharg e able Battery .................................................................................................. 7
4.3 Loading Recording Paper ........................................................................................................ 8
4.4 Connecting Patient Cable ........................................................................................................ 8
4.5 Connecting Electrodes ............................................................................................................ 8
5 、 Operation Instructions and Setting .................................................................................................. 9
5.1 、 Power On ..................................................................................................................................... 9
5.2 、 Recording Mode ......................................................................................................................... 9
5 . 3 、 Operation Menu Setting ......................................................................................................... 10
5.4 、 Patient Info. Setting ................................................................................................................ 12
5. 5 、 Record ECG .............................................................................................................................. 12
5. 6 、 Freeze ECG ............................................................................................................................... 12
5. 7 、 ECG File Management ........................................................................................................... 13
5 . 8 、 U ART / USB communication .................................................................................................. 13
5 . 9 、 ECG Explanation on measurement ..................................................................................... 13
6 、 Cleaning, Sterilization and Maintenance ...................................................................................... 13
7 、 Troubleshooting and solution ......................................................................................................... 15
8 、 Service Warranty ................................................................................................................................ 16
9 、 Accessories .......................................................................................................................................... 17
Appendix A . 2 : Classification ................................................................................................................ 17
Appendix A .3 : Technical characteristics .......................................................................................... 18
Appendix A . 4 : Model and Specification ............................................................................................ 19

Digital E lectrocardiograph Operation Manual
1
1 、 Safety Guidance
THE design of the electrocardiograph (ECG) complies with IEC 60601-1 / GB 9706.1 -2007
( Medical Electrical Equipment: General Requirements for Safety ) and IEC 60601-2-25 /
GB10793-2000 ( Particular Requirements for Safety of Electrocardiographs ) . The
classification of this equipment is Class І , type CF, which means a higher degree of
protection against electric shock and the patient connection is fully isolated and
defibrillation protected. The equipment is not explosion-proof. Do not use it in the
presence of flammable anesthetics.The equipment is designed for continuous operation but
it not drip or splash-proof.
THE device also strictly follows the standard IEC 60601-1-2 / YY0505-2005 about the
electromagnetism compatibility of medical instrument. When the electromagnetism is
beyond the margin of the standard, the device may not work properly. When the abnormal
situation appears, please check and clear all the influence before the operation starts again.
POWER Supply and Environment Requirements of the equipment please refer to [Appendix
A : Specification and Electrical characteristics ]
1.2.1 Application environment and connection
WARNING :
♦ SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet.
♦ EXPLOSION HAZARD - Do not use the ECG in the presence of flammable anesthetic
mixture with oxygen or other flammable agents.
♦ If the integrity of external protective conductor in installation or arrangement is in doubt,
the ECG should be operated by the built-in rechargeable battery.
♦ Do not use in the presence of high static electricity or high voltage equipment which may
generate sparks.
♦ This equipment is not designed for internal use and direct cardiac application.
♦ Only patient cable and other accessories supplied by the manufacturer can be used,
otherwise the performance or electric shock protection can not be guaranteed.
♦ Be sure that all electrodes have been connected to the patient properly before operation.
♦ Auxiliary equipment connected to the analog and digital interfaces must be certified
according to IEC standards (e.g. IEC 950 for data processing equipment and IEC 60601-1
for medical equipment). Furthermore all configurations shall comply with the valid version
of IEC 60601-1-1. If in doubt, consult our technical service department or your local
distributor.
♦ The summation of leakage current should never exceed leakage current limits while
several other units are used at the same time.
♦ The potential equalization conductor can be connected to that of other equipment s when
necessary, to make sure that all these equipment s are connected with the potential
equalization bus bar of the electrical installation.
1.2.2 Application simultaneously with defibrillator, pace-maker and
high-frequency electrosurgical unit
♦ Be sure that the conductive parts of electrodes and associated connectors, including
neutral electrode, do not contact with earth or any other conducting objects.
♦ There is no danger for patients with pacemaker.
♦ Do not touch the patient, bed, table or the equipment while using defibrillator or
pacemaker simultaneously.
♦ Before defibrillating, make sure the patient is completely isolated and avoid touching any
metal part of the ECG machine in case of electric shock.

Digital E lectrocardiograph Operation Manual
2
♦ Before defibrillating, remove all electrodes, gel or cloth pieces from the patient in case
of any possible burning.
♦ Apply patient cable appointed by manufacturer only. Otherwise there might be electric
burn of the patient or damage of ECG machine.
♦ Electrodes with defibrillator protection should be applied. To avoid any possible electric
burn, it is recommended that only the patient cable and electrodes supplied by the
manufacturer to be applied while defibrillating.
♦ In order to avoid burning, please keep the electrode far away from the radio knife while
using electrosurgical equipment simultaneously.
1.2.3 Battery maintenance
WARNING :
♦ Improper operation may cause the battery hot, ignited or exploded, and it may lead to
declination of battery capacity. It is necessary to read the Operation Manual carefully.
♦ Disassembling or replacing battery should be done according to the Operation Manual,
and only battery of same model and specification provided by manufacturer should be used.
♦ Danger of explosion -- Do not reverse the anode and cathode when connecting the
battery.
♦ Do not use battery around fire or place over 60 ℃ . Do not heat or splash the battery. Do
not throw the battery into fire or water.
♦ When leakage or foul smell found, stop using the battery immediately. If skin or cloth
contact with the leakage liquid, cleanse it with clean water at once. If splashed into your
eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor
immediately.
♦ When the battery ’ s cycle life is over, stop using it, and contact the manufacturer or local
distributor for disposal or dispose the battery according to local regulations.
1.2.4 Cleaning & Disinfection
NOTE :
♦ Turn off the power before cleaning and disinfection. If mains supply used, the power
cord should be pulled out from the outlet, too. Prevent detergent from seeping into the
equipment.
♦ Do not immerse the unit or patient cable into liquid under any circumstances.
♦ Do not clean the unit and accessories with abrasive fabric and avoid scratching the
electrodes.
♦ Any remainder of detergent should be removed from the unit after cleaning.
♦ Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.
♦ Do not use high temperature, autoclaving or radiation sterilization processes.
WARNING :
♦ To prevent the spread of infection , the following precautions should be taken : (1) use
the disposable electrodes ; (2) regular cleaning of all components contact ing with the
patient ; (3) avoid to examine ECG for the patients with infectious ulcers etc .
1.2.5 EMC dec l aration
NOTE :
1. Powerful electromagnetic interference produced by radio station, transformer substation,
X-ray machine, CT-scanner, micro-waver, high-frequency treatment equipment, mobile
phone, wireless receiver, etc.
Solution : keep enough distance from this equipment.
2. AC interference caused by other equipment nearby
Solution : activate HUM filter, change power cable or use built-in battery