Model SE-1200 Series Service Manual Ver 1.5 Nov 2013

The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.

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.

II

Table of Contents Chapter 1 Warranty and Service ... 1 Chapter 2 Safety Guidance ... 4 2.1 Intended Use... 4 2.2 Warnings and Cautions... 4 2.2.1 Safety Warnings ... 5 2.2.2 Li-ion Battery Care Warnings ... 8 2.2.3 General Cautions ... 9 2.3 List of Symbols ... 10 Chapter 3 Overview ... 13 3.1 Technical Specifications ... 13 3.2 Electrode Placement (for Resting ECG) ... 15 3.3 Electrode Placement (for Exercise ECG) ... 17 3.4 Description of Hardware Design Principle ... 18 3.4.1 Main Board Description ... 19 3.4.2 ECG Board Description ... 20 3.4.3 PS900D Power Supply Module Description ... 21 3.4.4 Key Board Description ... 22 Chapter 4 Optional and Advanced Functions ... 23 4.1 Configuring a Bar Code Reader ... 24 4.2 Activating SCP/FDA-XML/DICOM/VCG Function ... 26 4.3 Implementing FTP Protocol ... 27 Chapter 5 Inspection and Troubleshooting... 34 5.1 Function Tests ... 34 5.2 System Tests ... 36 5.3 Module Tests ... 43 5.3.1 Main Board Test ... 43 5.3.2 ECG Board Test ... 45 5.3.3 Key Board Test ... 46 5.3.4 Power Supply Board Test ... 47 5.4 Troubleshooting... 48 Chapter 6 Electrocardiograph Disassembly ... 53 6.1 Disassembly Procedures... 53 6.2 Internal Boards and Interfaces ... 58 Chapter 7 Cleaning, Care and Maintenance ... 68 7.1 Cleaning ... 68 7.1.1 Cleaning the Main Unit and the Patient Cable ... 68 7.1.2 Cleaning the Reusable Electrodes ... 68 III

7.1.3 Cleaning the Print Head ... 69 7.2 Disinfection ... 69 7.3 Care and Maintenance ... 70 7.3.1 Recharge and Replacement of Battery ... 70 7.3.2 Recorder Paper ... 71 7.3.3 Visual inspection ... 72 7.3.4 Maintenance of the Main Unit and the Patient Cable ... 72 Chapter 8 Renewable Parts ... 74

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SE-1200 Series Electrocardiograph Service Manual

Warranty and Service

Chapter 1 Warranty and Service Standard Service EDAN provides a one-year-warranty for the warranted products (accessories are included). The warranty period begins on the date the products are shipped to customers. If a customer promptly notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or replace (with new or exchange replacement parts) EDAN’s products. EDAN warrants that any service it provides to customers will be performed by trained individuals in a workmanlike manner. Limitation of Warranty Direct, indirect or final damage and delay caused by the following situations for which EDAN is not responsible may void the warranty: Groupware is dismounted, stretched or redebugged. Unauthorized modification or misuse. Damage caused by operating beyond the environmental specifications for the medical product. Change or remove original serial number label or Manufacturer symbol. Improper use. Service Procedure (1) Fill in the Service Claim Form (SCF). Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and Problem Phenomena. EDAN should not have any obligation to take over the case without this information. The form can be downloaded at: http://www.edan.com.cn or obtained from EDAN’s Service Department. (2) Send EDAN the SCF and Select a Solution. Once the service department receives the fully filled SCF, EDAN’s engineer will offer a solution in three working days. EDAN will follow out the case based on the two conditions below:

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SE-1200 Series Electrocardiograph Service Manual

Warranty and Service

Within Warranty: There are two options: i) After receiving the Return Material Authorization (RMA) form from EDAN service department, the customer sends EDAN the defective parts and informs about the shipment tracking number. Then we will dispatch new part(s) to your confirmed address with confirmed shipping invoice. ii) The customer signs the Declaration Form and sends it back by email or fax. This form is legally certificated to make sure the customer or end-user will return the defective parts to EDAN on time. We will, at this option, dispatch the replacement one(s) with confirmed shipping invoice. NOTE: (1) Both Return Material Authorization Form and Declaration Form are offered by EDAN service department once the SCF is confirmed by service engineer. (2) The customer is responsible for freight & insurance charges when the equipment is shipped to EDAN for service, including custom charges. EDAN is responsible for the freight, insurance & custom charges from EDAN to the customer. Out of Warranty: After receiving the RMA form from the service department, the customer sends defective parts to EDAN. We will analyze the problems and discuss with the customer about either repairing or replacing the part(s). Once the maintenance fee is invoiced and paid, we will make sure to dispatch good part(s) to the confirmed address. NOTE: The customer is responsible for any freight & insurance charge for the returned product. (3) Obtain the RMA Form. Before the shipment of the materials, the customer must obtain an RMA form from our service department, in which the RMA number, description of returning parts and shipping instructions are included. The RMA number should be indicated on the outside of the shipping container. NOTE: EDAN should not have any obligation to the end-user or customer who returns the goods without the notification by EDAN’s service department. The sender takes full responsibility for the accounted fee.

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SE-1200 Series Electrocardiograph Service Manual

Warranty and Service

(4) Send the Parts to EDAN. Follow these recommended instructions: Please disassemble the parts with anti-static facility, do not touch the parts with naked hand. Please pack the parts safely before return. Please put the RMA number on the parcel. Please describe the returned parts as ‘sample of *****’ and put the total value on the invoice, and note on the invoice as ‘sample, no commercial value’. Please confirm the invoice with Edan before shipment. Please send back the parts after Edan’s confirmation. Contact Information If you have any question about maintenance, technical specifications or malfunctions of devices, do not hesitate to contact us. EDAN Instruments, Inc. TEL: +86-755-26898321, 26899221 FAX: +86-755-26882223, 26898330 E-mail: [email protected]

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

Chapter 2 Safety Guidance This chapter provides important safety information related to the use of SE-1200 series electrocardiograph.

2.1 Intended Use The intended use of SE-1200 series electrocardiograph 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 interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. WARNING 1. This equipment is not designed for intracardiac 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.

2.2 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.

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

2.2.1 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. 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 li-ion 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. 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. 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, the electrocardiograph recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times.

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

WARNING 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. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 15. Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously. 16. 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 electrocardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment. 17. If the wireless AP technology is used, in order to maintain compliance with the FCC RF exposure guidelines, the wireless AP should be installed and operated with a minimum distance of 20cm between the radiator and the human body. There should be no shield in or around the room where the wireless AP is used. 18. Fix attention on the examination to avoid missing important ECG waves. 19. 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. 20. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system. 21. 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. 22. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.).

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

WARNING 23. Do not exceed the maximum permitted load when using the multiple portable socket-outlet(s) to supply the system. 24. Multiple portable socket-outlets shall not be placed on the floor. 25. 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. 26. 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. 27. 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. 28. 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. 29. You should purchase computer, printer, treadmill, ergometer and BP monitor from the manufacturer. Otherwise, the manufacturer will not be held responsible for the maintenance of the PC hardware, operating system and other accessories. 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.

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

WARNING 31. The potential equalization bar can be connected to that of other equipment when necessary. Make sure that all the equipment is connected to the potential equalization terminal.

2.2.2 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 as manufacturer 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. Only when the device is off can the battery be installed or removed. 9. Remove the battery from the electrocardiograph when the electrocardiograph isn’t used for a long time. 10. If the battery is stored alone and not used for a long time, we recommend that the battery be charged at least once every 6 months to prevent overdischarge. -8-

SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

2.2.3 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. 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. Ruptured fuse must only be replaced with that of the same type and rating as the original. 5. 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. 6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

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SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

2.3 List of Symbols External output External input Equipment or part of CF type with defibrillator proof Caution Consult Instructions for Use

Potential equalization

Patient Cable Socket USB socket

Net port

Mains supply Battery indicator Battery recharging indicator

Delete key

Enter key

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SE-1200 Series Electrocardiograph Service Manual

Esc key/Reset key

Shift key

Fn key

Power On/Off key

1mV/COPY key

MODE key

SLEEP/WAKE UP key

PRINT/STOP key

Tab key/Feed paper key

UP/DOWN Arrow key

LEFT/RIGHT Arrow key / Lead switch key

Gender key

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Safety Guidance

SE-1200 Series Electrocardiograph Service Manual

Safety Guidance

Age Group key

Recycle

Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in the European Community The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. Federal (U.S.) law restricts this device to sale by or on the order of a physician. 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.

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SE-1200 Series Electrocardiograph Service Manual

Overview

Chapter 3 Overview The service manual is a reference for periodic preventive maintenance and corrective service procedures for SE-1200 series electrocardiograph. WARNING When performing a service procedure, follow the instructions in this manual exactly. Failure to do so could damage the device, invalidate the product warranty, and lead to serious personal injury. This guide provides troubleshooting information, disassembly procedures, and instructions for functional testing and performance verification. It is intended to be used by technically qualified service personnel only.

3.1 Technical Specifications Safety Standards: IEC 60601-1:1988+A1:1991+A2:1995 EN 60601-1:1990+A1:1993+A2:1995 IEC60601-1-2:2001+A1:2004 EN 60601-1-2:2001+A1:2006 IEC/EN60601-2-25 ANSI/AAMI EC11 IEC/EN 60601-2-51 Classifications: Anti-electric-shock type:

Class І with internal power supply

Anti-electric-shock degree:

CF type with defibrillation-proof

Degree of protection against harmful

Ordinary equipment (Sealed equipment without

ingress of water:

liquid proof)

Disinfection/sterilization method:

Refer to the user manual for details

Degree of safety of application in the

Equipment not suitable for use in the presence

presence of flammable gas:

of flammable gas

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SE-1200 Series Electrocardiograph Service Manual

Overview

Working mode:

Continuous operation

EMC:

CISPR 11 Group 1, Class A

Environment Requirements:

Temperature:

Transport and Storage

Working

-20ºC (-4ºF) ~ +55ºC (+131ºF)

+5ºC (+41ºF) ~ +40ºC (+104ºF)

25%~93%

25%~80%

Non-Condensing

Non-Condensing

700hPa ~1060hPa

860hPa ~1060hPa

Relative Humidity: Atmospheric Pressure: Power Supply Specifications: 1) Mains Supply:

Operating Voltage: 100V-240V~ Operating Frequency: 50Hz/60Hz Input Current = 0.9-0.4A 2) Internal li-ion rechargeable battery: SE-1200 Express: Rated voltage: 14.8V; Rated capacity: 2200mAh or 4400mAh SE-1200: Rated voltage: 14.8V; Rated capacity: 2200mAh 3) Fuse Specification: T1AL250VP Ø5×20

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SE-1200 Series Electrocardiograph Service Manual

Overview

3.2 Electrode Placement (for Resting ECG) The electrodes’ positions on the body surface are shown in the following table and figure. Standard 12-Lead Placement

Only for the Reusable Electrodes

Only for the Disposable Electrodes

IEC

AHA

Electrode Placement

C1

V1

Fourth intercostal space at the right border of the sternum

C2

V2

Fourth intercostal space at the left border of the sternum

C3

V3

Fifth rib between C2 and C4

C4

V4

Fifth intercostal space on the left midclavicular line

C5

V5

Left anterior axillary line at the horizontal level of C4

C6

V6

Left midaxillary line at the horizontal level of C4

L

LA

Right arm/Right deltoid

R

RA

Left arm/Left deltoid

F

LL

Right leg/Upper leg as close to torso as possible

N

RL

Left leg/Upper leg as close to torso as possible

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SE-1200 Series Electrocardiograph Service Manual

Overview

NEHB Placement

IEC

AHA

Electrode Placement

Nst

A1

Attachment point of the second rib to the right sternal edge

Nax

A2

Fifth intercostal space on the left posterior axillary line

Nap

V4

Left mid-clavicular line in the fifth intercostal space

R

RA

Right arm

L

LA

Left arm

N or RF

RL

Right leg

F

LL

Left leg

Frank Lead Placement (for VCG)

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