EDAN INSTRUMENTS DX12TREDAN User Manual

About this Manual

Statement

This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.

EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.

Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party.

The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN.

EDAN holds the rights to modify, update, and ultimately explain this manual.

Responsibility of the Manufacturer

EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and

The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use.

Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

WARNING

A WARNING label advises against certain actions or situations that could result in personal injury or death.

CAUTION

A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

NOTE A NOTE provides useful information regarding a function or a procedure.

Table of Contents

Chapter 1 Safety Guidance ........................................................................................................... 1

1.1 Intended Use/Indications for Use ........................................................................................ 1

1.2 Warnings and Cautions ........................................................................................................ 1

1.2.1 General Warnings ...................................................................................................... 1

1.2.2 Battery Care Warnings .............................................................................................. 5

1.2.3 General Cautions ....................................................................................................... 5

1.3 List of Symbols ................................................................................................................... 6

Chapter 2 Introduction .................................................................................................................. 8

2.1 Assembling the System ....................................................................................................... 8

2.1.1 PADECG System ...................................................................................................... 8

2.1.2 DX12(iOS) Transmitter ........................................................................................... 10

2.1.2.1 Keys and Icons .............................................................................................. 11

2.1.2.2 Setting the Menu ........................................................................................... 12

2.2 Installing the Software ...................................................................................................... 12

2.2.1 System Running Environment ................................................................................ 12

2.2.2 About Installation .................................................................................................... 13

2.2.3 Matching DX12(iOS) Transmitter with iOS Tablet ................................................ 13

2.3 Features ............................................................................................................................. 14

Chapter 3 Preparations Before Operation ................................................................................. 15

3.1 Preparing the Patient ......................................................................................................... 15

3.1.1 Instructing the Patient ............................................................................................. 15

3.1.2 Cleaning the Skin .................................................................................................... 15

3.2 Connecting the Patient Cable ............................................................................................ 15

3.3 Attaching Electrodes ......................................................................................................... 16

3.3.1 Electrode Placement ................................................................................................ 17

3.3.2 Attaching the Reusable Electrodes .......................................................................... 18

3.3.2.1 Attaching the Limb Electrodes ...................................................................... 18

3.3.2.2 Attaching the Chest Electrodes ..................................................................... 18

3.3.3 Attaching the Disposable Electrodes ....................................................................... 19

Chapter 4 Operation Instructions .............................................................................................. 20

4.1 Entering Patient Information ............................................................................................. 20

4.2 Sampling ECG Data .......................................................................................................... 21

4.3 Analyzing ECG Data ......................................................................................................... 22

4.4 Printing Reports ................................................................................................................ 24

4.5 Processing Patient Records ............................................................................................... 25

4.6 Configuring the System..................................................................................................... 26

4.6.1 Patient Information Setting ..................................................................................... 26

4.6.2 Sampling Storage Setting ........................................................................................ 27

III

4.6.3 Filter Setting ............................................................................................................ 28

4.6.4 Transmission Setting ............................................................................................... 28

4.6.5 Other Setting ........................................................................................................... 29

Chapter 5 Hint Information ........................................................................................................ 30

Chapter 6 Cleaning, Care and Maintenance ............................................................................. 31

6.1 General Points ................................................................................................................... 31

6.2 Cleaning ............................................................................................................................ 31

6.2.1 Cleaning the DX12(iOS) Transmitter ..................................................................... 32

6.2.2 Cleaning the Patient Cable ...................................................................................... 32

6.2.3 Cleaning the Reusable Electrodes ........................................................................... 32

6.3 Disinfection ....................................................................................................................... 33

6.3.1 Disinfecting the DX12(iOS) Transmitter ................................................................ 33

6.3.2 Disinfecting the Patient Cable ................................................................................. 33

6.3.3 Disinfecting the Reusable Electrodes ..................................................................... 34

6.4 Care and Maintenance ....................................................................................................... 34

Chapter 7 Accessories .................................................................................................................. 36

Chapter 8 Warranty and Service ................................................................................................ 37

8.1 Warranty ............................................................................................................................ 37

8.2 Contact information .......................................................................................................... 37

Appendix 1 Technical Specifications .......................................................................................... 38

A1.1 Safety Specifications ...................................................................................................... 38

A1.2 Environment Specifications ........................................................................................... 38

A1.3 Physical Specifications ................................................................................................... 39

A1.4 Power Supply Specifications .......................................................................................... 39

A1.5 Performance Specifications ............................................................................................ 39

Appendix 2 EMC Information .................................................................................................... 41

Appendix 3 Abbreviation ............................................................................................................. 47

PADECG User Manual Safety Guidance

Chapter 1 Safety Guidance

This chapter provides important safety information related to the use of PADECG.

1.1 Intended Use/Indications for Use

The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by PADECG can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. It is mainly used in ECG inpatient department of hospitals or healthcare facilities.

WARNING

1. This system is not designed for intracardiac use or direct cardiac application.

2. This system is not intended for home use.

3. This system is not intended for treatment or monitoring.

4. This system is intended for use on adult and pediatric patients only.

5. The results given by the system should be examined based on the overall clinical condition of the patient, and they cannot substitute for regular checking.

1.2 Warnings and Cautions

To use the system safely and effectively, firstly be familiar with the operation method of Windows and read the user manual in detail to be familiar with the proper operation method for the purpose of avoiding the possibility of system failure. The following warnings and cautions must be paid more attention to during the operation of the system.

1.2.1 General Warnings

WARNING

1. The system is intended to be used by qualified physicians or personnel professionally

trained. They should be familiar with the contents of this user manual before operation.

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PADECG User Manual Safety Guidance

WARNING

2. Only qualified service engineers can install this equipment, and only service

engineers authorized by the manufacturer can open the shell. Otherwise, safety hazards may happen.

3. EXPLOSION HAZARD - Do not use the system in the presence of flammable

anesthetic mixtures with oxygen or other flammable agents.

4. Only the patient cable and other accessories supplied by the manufacturer can be

used. Or else, the performance and electric shock protection cannot be guaranteed. The system has been safety tested with the recommended accessories, peripherals, and leads, and no hazard is found when the system is operated with cardiac pacemakers or other stimulators.

5. Make sure that all electrodes are connected to the patient correctly before operation.

6. Ensure that the conductive parts of electrodes and associated connectors, including

neutral electrodes, do not come in contact with earth or any other conducting objects.

7. Disposable electrodes must be used during defibrillation.

8. Electrodes of dissimilar metals should not be used; otherwise it may cause a high

polarization voltage.

9. The disposable electrodes can only be used for one time.

10. Do not touch the patient, bed, table or the equipment while using the ECG together

with a defibrillator.

11. Do not touch accessible parts of electrical equipment and the patient simultaneously.

12. The use of equipment that applies high frequency voltages to the patient (including

electrosurgical equipment and some respiration transducers) is not supported and may produce undesired results. Disconnect the patient data cable from the ECG workstation, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment.

13. Fix attention on the examination to avoid missing important ECG waves.

14. Do not connect any equipment or accessories that are not approved by the

manufacturer or that are not IEC/EN 60601-1 approved to the system. The operation or use of non-approved equipment or accessories with the system is not tested or supported, and system operation and safety are not guaranteed.

15. The use of patient cable and other accessories not supplied by the manufacturer may

result in increased emissions or decreased immunity of the equipment.

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PADECG User Manual Safety Guidance

WARNING

16. Any non-medical equipment (such as the external printer) is not allowed to be used

within the patient vicinity (1.5m/6ft.).

17. Accessory equipment connected to the analog and digital interfaces must be certified

according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configuration shall comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt, consult our technical service department or your local distributor.

18. Connecting any accessory (such as external printer) or other device (such as the

computer) to this system makes a medical system. In that case, additional safety measures should be taken during installation of the system, and the system shall provide:

a) Within the patient environment, a level of safety comparable to that provided by

medical electrical equipment complying with IEC/EN 60601-1, and

b) Outside the patient environment, the level of safety appropriate for non-medical

electrical equipment complying with other IEC or ISO safety standards.

19. All the accessories connected to system must be installed outside the patient vicinity,

if they do not meet the requirement of IEC/EN 60601-1.

20. You are recommended to purchase the iOS tablet from the manufacturer. Otherwise,

the manufacturer will not be held responsible for the maintenance of the hardware, operating system and other accessories.

21. If multiple instruments are connected to a patient, the sum of the leakage currents

may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.

22. Connecting to other devices may decrease the antistatic gradation of the system

during operation.

23. Make sure that there is no intense electromagnetic interference source around when

using the wireless system of PADECG. Furthermore, Keep a unobstructed distance of at most 3 meters between DX12(iOS) Transmitter and the iOS tablet.

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PADECG User Manual Safety Guidance

WARNING

24. Do not open the battery cover of DX12(iOS) Transmitter when using the wireless

system of PADECG.

25. The iOS tablet shall comply with the valid version of the standard IEC 60950 and be

used outside the patient environment (at least 2 meters away from the patient). The iOS tablet shall be charged outside the patient environment, and no operations are permitted during the charging.

26. The device shall not be serviced or maintained while in use with a patient.

27. The medical electrical equipment needs to be installed and put into service according

to Appendix 2 EMC information.

28. Portable and mobile RF communications equipment can affect medical electrical

equipment, refer to the recommended separation distances provided in Appendix 2 EMC Information.

29. The equipment should not be used adjacent to or stacked with other equipment, refer

to the recommended separation distances provided in Appendix 2 EMC Information.

30. Assembly of the ECG workstation and modifications during actual service life shall be

evaluated based on the requirements of IEC60601-1.

31. Check the gain and speed of the report thoroughly when confirming diagnosis.

32. The device is MR unsafe. It is not intended for use in an MRI environment.

33. Magnetic and electrical fields are capable of interfering with the proper performance

of the device. For this reason make sure that all external devices operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

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PADECG User Manual Safety Guidance

1.2.2 Battery Care Warnings

WARNING

1. Improper operation may cause the internal battery to be hot, ignited or exploded, and

it may lead to the decrease of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages.

2. Batteries of the same model and specification as manufacture configuration should be

used.

3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when

installing the battery.

4. Do not heat or splash the battery or throw it into fire or water.

5. Do not destroy the battery; do not pierce battery with a sharp object such as a needle;

do not hit with a hammer, step on or throw or drop to cause strong shock; do not disassemble or modify the battery.

6. When leakage or foul smell is found, stop using the battery immediately. If your skin or

cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately.

7. Properly dispose of or recycle the depleted battery according to local regulations.

8. Remove the battery from the transmitter if the system won’t be used for a long time.

9. Replace the depleted battery before use.

1.2.3 General Cautions

CAUTION

1. Avoid liquid splash and excessive temperature. The temperature must be kept

between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and 55 ºC during transportation and storage.

2. Do not use the equipment in a dusty environment with bad ventilation or in the

presence of corrosive.

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PADECG User Manual Safety Guidance

No.

Symbol

Description

DEFIBRILLATION-PROOF TYPE CF APPLIED PART

Caution

Operating instructions

Warning (Background: Yellow; Symbol&Outline: Black)

Refer to User Manual (Background: Blue; Symbol: White)

Non- ionizing electromagnetic radiation

CAUTION

3. Make sure that there is no intense electromagnetic interference source around the

equipment, such as radio transmitters or mobile phones etc. Attention: large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc. is likely to bring electromagnetic interference.

4. The device and accessories are to be disposed of according to local regulations after

their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of them together with house-hold garbage. At the end of their lives hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product.

5. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

1.3 List of Symbols

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PADECG User Manual Safety Guidance

General symbol for recovery/recyclable



Part Number



SERIAL NUMBER

Date of manufacture

MANUFACTURER

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

CE marking

Disposal method

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.

FCC ID: SMQDX12TREDAN

Federal Communications Commission: FCC ID: SMQDX12TREDAN

MR Unsafe–Keep away from magnetic resonance imaging (MRI) equipment

NOTE: The user manual is printed in black and white.

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PADECG User Manual Introduction

iOS Tablet

DX12(iOS) Transmitter

Patient

Patient Cable

Wireless

Chapter 2 Introduction

PADECG as mobile ECG Workstation has similar functions with an ordinary ECG Workstation. ECG data can be sampled, analyzed and stored in a Pad, ECG waves can be reviewed. Auto measurement and diagnosis are available, and the diagnosis template can be edited.

PADECG includes the following equipment, you can also purchase the iOS tablet.

 DX12(iOS) Transmitter  Patient Cable  Electrodes

NOTE: The pictures and windows in this manual are for reference only.

2.1 Assembling the System

2.1.1 PADECG System

WARNING

DX12(iOS) Transmitter of the wireless system uses the Bluetooth technology, which could make the patient with the pacemaker uncomfortable. Keep DX12(iOS) Transmitter far away from the pacemaker when using the wireless system of PADECG.

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PADECG User Manual Introduction

WARNING

1. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configuration shall comply with the valid version of the standard IEC/EN 60601-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt, consult our technical service department or your local distributor.

2. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.

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PADECG User Manual Introduction

Patient Cable Socket

2.1.2 DX12(iOS) Transmitter

DX12(iOS) Transmitter Appearance

Front Panel



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PADECG User Manual Introduction

Keys/Icons

Description

After batteries are installed, press this key to turn on/off DX12(iOS) Transmitter.

When the Menu screen is displayed, press this key to return to the previous screen.

When the Main or Menu screen is displayed, press this key to enter the next menu.

Press this key, and then press in 1.2 seconds to lock / unlock the keypad.

When the Main screen is displayed, press this key to switch the lead. When the Menu screen is displayed, press this key to display an item in black.

Icon for Bluetooth Connection If this icon is not displayed on the main screen, you need to match the device

manually.

Icon for Keypad Locked If no operation is taken, the Main screen will be displayed and the keyboard

will be locked automatically in 8 seconds.

Icon for Battery Capacity When the battery is weak, a hint will be displayed in PADECG software.

2.1.2.1 Keys and Icons

Main Screen Menu Screen

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