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Summary of Contents for MicroPort EverPace Columbus DF-5A
- Page 1 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Cardiac Electrophysiology Stimulator User Manual Shanghai MicroPort EP MedTech Co., Ltd. A-C6F06-001 Rev. E, Revision date: 2022-06 Statement...
- Page 2 All user manuals, self-contained CDs and electronic documents of this product are protected by copyright law. Without prior written authorization from Shanghai MicroPort EP Medtech Co., Ltd., all or part of content contained in this user manual shall not be reproduced, copied, deleted or translated by anybody in any form and shall not be transmitted, retrieved or stored on the Internet in any form.
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Page 3: Table Of Contents
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Table of Contents Overview ................................... 1 Application ..........................错误!未定义书签。 Safety Information ..............................1 Function ..................................3 5. Technical Index ................................5 6. Front View of the Instrument ............................ 6 7. Rear View of the Instrument ............................. 7 8. -
Page 4: Overview
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Read carefully these instructions before use. 1. Overview DF-5A cardiac electrophysiology stimulator is a new high-tech product that integrates advanced technology and medical expertise. It was designed meticulously by combining clinical practice of many years and absorbing the constructive suggestions from experts in terms of cardiac electrophysiology. - Page 5 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Stimulator operates normally under such situation. ④ Intentional misuse of Columbus™ Cardiac Electrophysiology Stimulator may cause serious injury to the operator and patient. 3.3 Cautions ① Before the operation, check the performance of the instrument, make sure the electricity quantity is sufficient and be familiar with the operation process.
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Page 6: Function
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Connect the pump system to socket in other circuits, which is different from that used by other devices. Consult manufacturer for help. ⑱ The Cardiac electrophysiology stimulator does not contain any parts with user-performed maintenance. ⑲... - Page 7 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Fixed Delay Number number 1~99 times (5) S stimulus increasing/decreasing Delay Increment (6) Quick stop stimulus Stop Stop 4.2 Premature beat stimulus (1) S Synchronous programmable premature beat stimulus, short for S ) stimulus Programm 4 (8) S generate 1 premature beat-S...
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Page 8: Technical Index
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 5. Technical Index 5.1 Safety Classification ① Product type: DF-5A ② Protection against electric shock: internally powered equipment. ③ Applied Parts type : Type CF Applied Parts and Defibrillation-proof Applied Parts ④ Protection against harmful ingress of water or particulate matter: it is non-protective equipment. ⑤... -
Page 9: Front View Of The Instrument
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 5.10 Output pulse width Intracardiac stimulating pulse width 1ms factory set, unadjustable. 5.11.10 R wave heart rate sensitivity body surface ≥1mv 5.12 Power supply 1 set of rechargeable polymer lithium battery (2000mAh), power supply 7.4V. The battery must be charged continuously for 5~6 hours. -
Page 10: Rear View Of The Instrument
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 7. Rear View of the Instrument 7 / 24... -
Page 11: Accessory
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 8. Accessory 9. Functions of the Instrument and Instruction of Key Panel 9.1 Description of functions key ○ 1 Battery charging socket The plug of the charger which outputs VDC is inserted into the socket to charge the battery; it should be charged continuously for 5~6 hours. - Page 12 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F ○ 8 Display window Display: R-R self heart rate, S stimulus frequency, the coupling interval of S ○ 9 Display window Display: S or the coupling interval of RS premature beat stimulus ○ 10 Display window Display: S the coupling interval of the second premature beat stimulus ○...
- Page 13 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F In Stimulus mode, when S lights, the display window only indicates the frequency and interval of S ; the instrument only generate S basic stimulus. The way of S stimulus includes: S continuous, S increasing/decreasing, S timing, S number.
- Page 14 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F When press S stimulus increasing/decreasing key for the first time, the instrument will activate S frequency increasing (If “0+9”combination key is not set before generating increasing stimulus, when the frequency is over 256 times/min., the instrument will stop stimulus automatically, This is due to its function of high frequency output limitation.
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Page 15: Basic Operation Procedure
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 256times/min., it will stop stimulating automatically. If the stimulus frequency needs to be over 256times/min., it necessary to use the combination key before or in process of stimulating. Set as follows: Press and hold “0”, then press “9” till hear a long beep to make stimulus frequency over 256 times/min., When this function is canceled in the following stimulus, the frequency is still limited to 256times/min. -
Page 16: Operation For Generating Stimulus Pulse
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Adjusted heart rate sensing sensitivity. The stimulus pulse of the instrument adopts the R wave trigger mode, that is, according to the release key, to perceive a R wave, in the delay of a RS1 interval, and then send out the stimulus pulse. The delay value of RS1 is calculated by the instrument based on the perception of the patient's own heart rate. - Page 17 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 11.2“S ”timing stimulus. 11..2.1 The instrument is in state of stop. 11.2.2 Select intracardiac by “Output Option” switch. 11.2.3 (Mode) key in position S 11.2.4 (Display Option) key in position frequency. 11.2.5 Set stimulus frequency by number key “0~9” then press “Confirm”. 11.2.6 (Display Option) in timing position.
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Page 18: The Use Of Charger And Battery
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F 11.5.9 Stimulus ratio are 8:1 and 4:1, i.e. 8 (4) of S followed by 1 added premature beat S It is switched by “Output Option”. 11.5.10 Press (S Sn Programmed) key to generate S programming premature beat stimulus, stop for 5 seconds then automatically generate stimulus pulse. -
Page 19: Authorized Representative
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F to instructions for use. Refer to instruction manual The equipment is mark of defibrillation-prevention of CF type Defibrillation-proof Type CF Applied Part The identification is “Authorized representative in EU market” Authorized representative Manufacturer Representing the identification of Stimulator manufacturer Please read the specification before using the Stimulator Caution Correct placement direction of packing case during... -
Page 20: Temperature Limitation
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Temperature The temperature during transportation shall Limitation be kept in between -40℃ and 50℃. The humidity during transportation shall Humidity be not exceed 80%. Limitation Separate collection of The equipment and accessories shall abide by requirements of electronic and separate collection of electronic and electrical equipment at end electrical equipment... -
Page 21: After-Sale Service
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F environment”, good ventilation, no corrosion gas. The operation duration is 5 hours. lint-free flannel/mat dipped in Keep the surface of the instrument clean; wipe its surface use 75% ethyl alcohol after each use and put into the aluminum case. Otherwise it may result bad effect. lint-free flannel/mat dipped in Clean its input/output wire use 75% ethyl alcohol after each use;... -
Page 22: Appendix I: Connection Diagram
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Self-test of is required before every use, and maintenance is not allowed during the stimulator application (connected to patient). Specific inspection items are as below: All the knobs are not released, adjustment of the knob can modify values on the screen properly. ... -
Page 23: Appendix Ii：emc Information
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: F Appendix II：EMC Information The data in the following table shows that the stimulator conforms to requirements in IEC60601-1-2:2007; Guidance and manufacturer’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission DF-5A/Cardiac EP stimulator is intended for use in the electromagnetic environment specified below. -
Page 24: Electromagnetic Environment
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: E Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity DF-5A/Cardiac EP stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of DF-5A/Cardiac EP stimulator should assure that it is used in such an environment. - Page 25 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: E Power frequency 3A/m 3A/m Power frequency magnetic fields (50/60Hz) magnetic field IEC61000-4-8 Should be at levels characteristic of a typical location in a typical commercial or hospital NOTE U T is the a.c. mains voltage prior to application of the test level. environment.
- Page 26 DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: E NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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Page 27: Appendix Iii：common Failures And Troubleshooting Absorption And Reflection From Structures, Objects And People
DF-5A Cardiac Electrophysiology Stimulator A-C6F06-001: E For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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