SE-601 Series Electrocardiograph User Manual Nov 2011

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.

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Table of Contents Chapter 1 Safety Guidance ... 1 1.1 Intended Use ... 1 1.2 Warnings and Cautions ... 1 1.2.1 Safety Warnings ... 1 1.2.2 Li-ion Battery Care Warnings ... 4 1.2.3 General Cautions... 5 1.3 List of Symbols... 6 Chapter 2 Introduction... 9 2.1 Top Panel ... 10 2.2 Keyboard and Keys ... 11 2.3 Rear Panel... 12 2.4 Right Panel ... 13 2.5 Bottom Panel ... 16 2.6 Function Features ... 17 Chapter 3 About SE-601 Application ... 18 3.1 Selecting Menu Functions ... 18 3.2 Entering Data... 19 3.3 Selecting an Option from a List... 20 3.4 About the main Screen... 20 3.5 About the System Setup Screen... 24 3.6 About the File Manage Screen... 26 Chapter 4 Operation Preparations... 29 4.1 Power and Earthing ... 29 4.2 Loading/Replacing Recorder Paper... 30 4.3 Preparing the Patient... 33 4.3.1 Instructing the Patient ... 33 4.3.2 Preparing the Skin ... 33 4.4 Connecting the Patient Cable to the Electrocardiograph and Electrodes ... 33 4.5 Attaching Electrodes to the Patient... 34 4.5.1 Reusable Electrodes ... 35 4.5.2 Disposable Electrodes ... 37 4.6 Inspection before Power-On ... 38 Chapter 5 Switching On the Electrocardiograph... 40 Chapter 6 Entering Patient Information ... 41 6.1 Entering Patient ID ... 41 6.2 Entering Other Information ... 42 Chapter 7 Printing ECG Reports ... 43 7.1 Auto Mode ... 43 7.2 Manual Mode... 45 7.3 Rhythm Mode ... 47 7.4 R-R Mode ... 49 7.5 Transmitting ECG Data to the PC ... 50 7.5.1 Transmitting ECG Data through the Serial Port ... 50 7.5.2 Transmitting ECG Data through the Net Port ... 51 III

7.6 Copy Printing... 51 7.7 ECG Reports... 52 7.7.1 ECG Reports in the Auto Mode ... 52 7.7.2 ECG Reports in the Rhythm Mode ... 54 7.7.3 ECG Reports in the Manual Mode... 55 7.7.4 ECG Reports in the R-R Mode ... 56 7.7.5 ECG Reports Printed by the USB Printer ... 58 Chapter 8 Managing Files ... 60 8.1 Storage Upgrade Function ... 62 8.2 Transmitting Files to the PC ... 62 8.2.1 Transmitting Files through the Serial Port ... 63 8.2.2 Transmitting Files through the Net Port... 64 8.3 Copying Files between SE-601 and the U Disk ... 66 8.4 Editing Patient Information ... 68 8.5 Deleting Files... 69 8.6 Previewing a File (Only for SE-601B/C) ... 70 8.7 File Printing ... 72 Chapter 9 System Setup... 73 9.1 Work Mode Setup ... 73 9.1.1 Specifying Work Mode ... 74 9.1.2 Specifying Manual Style ... 75 9.1.3 Specifying Rhythm Style ... 75 9.1.4 Specifying Auto Style ... 75 9.1.5 Specifying Sampling Mode... 76 9.1.6 Specifying Recording Sequence ... 77 9.1.7 Inputting Sampling Time... 77 9.2 Filter Setup ... 78 9.2.1 Setting AC Filter ... 78 9.2.2 Setting EMG Filter... 78 9.2.3 Setting DFT Filter ... 79 9.2.4 Setting Lowpass Filter... 79 9.3 Record Setup... 79 9.3.1 Specifying Recording Device ... 80 9.3.2 Setting Paper Marker... 81 9.3.3 Selecting Patient Information... 83 9.3.4 Setting Speed... 83 9.3.5 Setting Gain... 83 9.3.6 Selecting Template ... 84 9.3.7 Selecting Measure ... 84 9.3.8 Selecting Minnesota Code... 84 9.3.9 Selecting Analysis ... 84 9.3.10 Selecting Position Marker ... 85 9.4 Lead Setup ... 85 9.4.1 Setting Rhythm Lead1/2/3 ... 86 9.4.2 Setting Lead Sequence ... 86 9.5 Transmission Setup... 87 9.6 Display & Sound Setup ... 88 9.6.1 Setting Brightness (Only for SE-601B) ... 89 9.6.2 Selecting Display Colors (Only for SE-601C)... 89 IV

9.6.3 Selecting Antialising (Only for SE-601B/C)... 89 9.6.4 Setting Key Volume ... 89 9.6.5 Setting Hint Volume ... 90 9.6.6 Setting QRS Volume ... 90 9.6.7 Setting Notification Volume... 90 9.7 Patient Question... 90 9.7.1 Specifying ID Mode... 91 9.7.2 Selecting ID Hint... 91 9.7.3 Selecting Gender/Height/Weight/BP/Race/Medication/Ward NO/Doctor/Technician.. 92 9.7.4 Specifying H/W Unit... 92 9.7.5 Specifying BP Unit... 92 9.7.6 Selecting Next Patient ... 93 9.7.7 Setting Prompt... 93 9.7.8 Inputting Extra Question ... 94 9.8 Date & Time Setup ... 94 9.8.1 Setting Current Date/Current Time ... 95 9.8.2 Setting Date Mode... 95 9.8.3 Setting Time Mode... 95 9.8.4 Setting Period Interval and Period Duration ... 95 9.8.5 Setting Power-Off Time ... 96 9.8.6 Setting LCD Off Time... 96 9.9 More Setup ... 96 9.9.1 Choosing a Language... 97 9.9.2 Setting Pacemaker Detection Sensitivity ... 97 9.9.3 Setting Save Option... 97 9.9.4 Entering Institution... 98 9.9.5 Restoring Default Settings ... 98 9.9.6 Setting Extern Input/Extern Output ... 99 Chapter 10 Switching Off the Electrocardiograph ... 100 Chapter 11 Hint Information ... 101 Chapter 12 Troubleshooting... 102 Chapter 13 Cleaning, Care and Maintenance ... 106 13.1 Cleaning... 106 13.1.1 Cleaning the Main Unit and the Patient Cable... 106 13.1.2 Cleaning the Reusable Electrodes... 106 13.1.3 Cleaning the Print Head ... 106 13.2 Disinfection ... 107 13.3 Care and Maintenance ... 107 13.3.1 Recharge and Replacement of Battery ... 107 13.3.2 Recorder Paper ... 109 13.3.3 Visual inspection ... 109 13.3.4 Maintenance of Main Unit, Patient Cable and Electrodes ... 109 Chapter 14 Accessories ... 112 Chapter 15 Warranty & Service ... 114 15.1 Warranty... 114 15.2 Contact information ... 114 Appendix 1 Technical Specifications ... 115 V

A1.1 Safety Specifications ... 115 A1.2 Environment Specifications... 116 A1.3 Physical Specifications ... 116 A1.4 Power Supply Specifications ... 116 A1.5 Performance Specifications ... 117 Appendix 2 EMC Information... 119 Appendix 3 Abbreviation... 124

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

Chapter 1 Safety Guidance This chapter provides important safety information related to the use of SE-601 series electrocardiograph (hereinafter called SE-601).

1.1 Intended Use The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. WARNING 1. This equipment is not designed for internal use or direct cardiac application. 2. This equipment is not intended for home use. 3. This equipment is not intended for treatment or monitoring. 4. This equipment is intended for use on adult and pediatric patients only. 5. The results given by the equipment should be examined based on the overall clinical condition of the patient, and they can not substitute for regular checking.

1.2 Warnings and Cautions In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused by improper operation, please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use. Please pay more attention to the following warning and caution information.

1.2.1 Safety Warnings WARNING 1. The electrocardiograph 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. 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell.

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

WARNING 3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixtures with oxygen or other flammable agents. 4. 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. 5. Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, electrical shock or other injuries may happen to the patient or operator. 6. If the integrity of the external protective conductor is in doubt, the equipment should be powered by an internal rechargeable battery. 7. Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks. 8. Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection can not be guaranteed. 9. Make sure that all electrodes are connected to the patient correctly before operation. 10.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. 11.If reusable electrodes with electrode gel are used during defibrillation, electrocardiograph recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times. 12.Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 13.The disposable electrodes can only be used for one time. 14.The electrocardiograph has been safety tested with the recommended accessories, peripherals, and leads, and no hazard is found when the electrocardiograph is operated with cardiac pacemakers or other stimulators. 15.Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 16.Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously. 17.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 cable from the electrocardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment. -2-

SE-601 Series Electrocardiograph User Manual

Safety Guidance

WARNING 18.If the wireless AP technology is used, the minimum distance between the radiator and the human body should be not less than 20cm. Use the supplied antenna only. There should be no shield in or around the room where the wireless AP is used. 19.Fix attention on the examination to avoid missing important ECG waves. 20.SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. 21.SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlets supplying the system. 22.Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1-1 approved to the electrocardiograph. The operation or use of non-approved equipment or accessories with the electrocardiograph is not tested or supported, and electrocardiograph operation and safety are not guaranteed. 23.Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.). 24.Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the system. 25.Multiple portable socket-outlets shall not be placed on the floor. 26.Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system. 27.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 configurations shall comply with the valid version of the standard IEC/EN 60601-1-1. 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 60601-1-1. If in doubt, consult our technical service department or your local distributor.

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

WARNING 28.Parts and accessories used must meet the requirements of the applicable IEC/EN 601 series safety standards, and/or the system configuration must meet the requirements of the IEC/EN 60601-1-1 medical electrical systems standard. 29.Connecting any accessory (such as external printer) or other device (such as the computer) to this electrocardiograph 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 30.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. 31.The potential equalization bar can be connected to that of other equipment when necessary. Make sure that all these devices are connected to the potential equalization terminal.

1.2.2 Li-ion Battery Care Warnings WARNING 1. Improper operation may cause the internal li-ion battery (hereinafter called 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. Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and batteries of the same model and specification 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.

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

WARNING 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. Only when the device is off can the battery be installed or removed. 9. Remove the battery from the electrocardiograph when the electrocardiograph is not used for a long time. 10.If the battery is stored alone and not used for a long time, we recommend that the battery should be charged at least once every 6 months to prevent overdischarge.

1.2.3 General Cautions CAUTION 1. Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. 2. 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. 3. Do not use the equipment in a dusty environment with bad ventilation or in the presence of corrosive. 4. 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. 5. Ruptured fuse must only be replaced with that of the same type and rating as the original. 6. 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. 7. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

1.3 List of Symbols External output

External input

Equipment or part of CF type with defibrillator proof

Caution

Consult Instructions for Use

Potential equalization

Mains Supply

Battery indicator

Battery recharging indicator Delete key Enter key Esc key Space key/Feed paper key

Shift key

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

Fn key

Power On/Off key

MODE key

RESET key

1mV/COPY key

START/STOP key

Tab key

Recycle



Part Number



Serial Number

Manufacturer

Date of Manufacture

The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.

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SE-601 Series Electrocardiograph User Manual

Safety Guidance

Authorized Representative in the European Community With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No. 601.1 It indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life Rx only (U.S.)

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

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SE-601 Series Electrocardiograph User Manual

Introduction

Chapter 2 Introduction The 6-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms. The 6-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality thermal recorder. The manual, auto, rhythm or R-R mode can be chosen freely. SE-601 can be powered by the mains supply or a battery. With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer, the 6-channel electrocardiograph has advanced performance and high reliability. The compact size makes it suitable for clinic and hospital uses. The 6-channel electrocardiograph has three models: SE-601A, SE-601B and SE-601C. SE-601A adopts 192×64 dot single color LCD screen; SE-601B adopts 320×240 dot single color LCD screen; SE-601C adopts 640×480 dot multicolor TFT LCD screen. Configuration: main unit, power cord, patient cable, chest electrodes, limb electrodes, disposable electrodes, alligator clips, thermal recorder paper, fuses and battery. NOTE: The pictures and windows in this manual are for reference only.

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SE-601 Series Electrocardiograph User Manual

Introduction

2.1 Top Panel

Recorder

LCD Screen

Indicators From left to right on the top panel: A, B, C.

Keyboard

Figure 2-1 SE-601A

LCD Screen

Recorder

Indicators From left to right on the top panel: A, B, C.

Keyboard

 Figure 2-2 SE-601B / SE-601C

Indicator Symbol Name A B C

Explanation

Mains supply indicator

When the device is powered by the mains supply, this indicator is lit.

Battery indicator

When the device is powered by the battery, this indicator is lit.

Battery indicator

recharging When the battery is being recharged, this indicator is lit.

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SE-601 Series Electrocardiograph User Manual

Introduction

2.2 Keyboard and Keys A B (1, 2, 3)

C D

N

E

M

F

G

H

I

J

L K

Figure 2-3 SE-601A / SE-601B / SE-601C Keyboard

A B

Name

Explanation

Function Key

Selecting menu functions on the screen (Pressing F1, F2, F3 or F4 can move the cursor)

Indicator

1 indicates that the device is powered by the mains supply 2 indicates that the device is powered by the battery 3 indicates the battery charging status

C D E

Power on / off Esc

Canceling operation

Tab

Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward. In the MANU mode, press Tab to switch the lead group.

F

Space: adding a space between typed characters Feed Paper: before printing, if Paper Marker is set to Style1 or Style2, you can press the Space key to advance the recorder paper to the next black marker; if Paper Marker is set to No, you can press the Space key to advance the paper for about 2cm. Press the Space key again to stop advancing the paper.

G

MODE

Press this key to select a working mode among AUTO, MANUAL and RHYTHM. NOTE: Only in the Work Mode Setup window can the R-R mode be selected.

H

RESET

Draw the baseline to zero quickly in the case of baseline drift

I

1mV/COPY

In the AUTO mode, pressing the 1mV/Copy key can print the ECG report which was printed out last time.

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SE-601 Series Electrocardiograph User Manual

Introduction

In the MANU mode, pressing the 1mV/Copy key can insert a 1mV calibration mark in the printing course. J

START/STOP

Start/Stop printing reports

K

Fn

Inputting special characters. Press Fn + a to type è.

L

Shift

Inputting a capital letter. Press Shift + p to type a capital P.

M

Enter

Confirming operation

N

Delete

Deleting characters

2.3 Rear Panel

B

A

C

Figure 2-4 SE-601A / SE-601B / SE-601C Rear Panel

Name

A

Potential Conductor

Explanation

Equalization

B

Handle

C

Mains Supply Socket

Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation. Part for people to hold AC SOURCE: alternating current supply socket

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SE-601 Series Electrocardiograph User Manual

Introduction

2.4 Right Panel D

C

A

B

E

F

Figure 2-5 SE-601A / SE-601B / SE-601C Right Panel

Name

Explanation

A

Patient Cable Socket

Connecting to the patient cable

B

Serial Port

Connecting to a PC

C

USB Socket 1 (Optional)

Standard USB socket, connecting to a PC

USB Socket 2 (Optional)

Standard USB socket, connecting to a U disk or a USB printer recommended by the manufacturer

E

Net port

Standard net port, connecting to a PC

F

External Input / Output Socket

Connecting to the external signal device

D

1) Patient Cable Socket

: Applied part of type CF with defibrillator proof : Caution Definitions of corresponding pins: Pin

Signal

Pin

Signal

Pin

Signal

1

C2 / V2

6

SH

11

F / LL

2

C3 / V3

7

NC

12

C1 / V1 or NC

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SE-601 Series Electrocardiograph User Manual

Introduction

3

C4 / V4

8

NC

13

C1 / V1

4

C5 / V5

9

R / RA

14

RF (N) /RL or NC

5

C6 / V6

10

L / LA

15

RF (N) / RL

NOTE: The left side of “/” is European standard; and the right side is American standard. 2) Serial Port WARNING The isolated intensity of serial port is 1500V AC and the maximum voltage applied should not exceed +15V DC.

Definitions of corresponding pins: Pin

Signal

Pin

Signal

Pin

Signal

1

NC

4

NC

7

NC

2

RxD (input)

5

GND

8

NC

3

TxD (output)

6

NC

9

NC

3) External Input / Output Socket

Definitions of corresponding pins: Pin

Signal

Pin

Signal

1

GND

4

GND

2

GND

5

ECG Signal (input)

3

GND

6

ECG Signal (output)

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