Operating Instructions
Contents
1. 1 Overview Vision 5L Holter Recorder Description The Vision 5L Holter recorder is a battery operated solid state recorder designed for 24 to 48 hour continuous recording of ambulatory ECG data and the ability to detect and record pacemaker pulses in accordance with appropriate AAMI pacer detection criteria The Vision 5L is an AAMI Type device which is part of a conventional AECG monitoring system where the ECG is recorded on a CompactFlash memory card installed in the Vision 5L After the recording is complete the CompactFlash card is removed and placed in a Card Reader connected to the Vision Series Holter Analysis system Follow the instructions provided with your Vision Series system to down load and analyze the recorded ECG data The Vision 5L is compatible with Windows 98SE or higher and only computers complying with EN60950 should be used Indications for Use The Vision 5L Holter recorder is intended for patients requiring ambulatory Holter monitoring from 1 to 48 hours Such monitoring is most frequently used for the indications below 1 Evaluation of symptoms suggesting arrhythmia or myocardial ischemia 2 Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients 3 Evaluation of patients for ST segment changes 4 Evaluation of a patient s response after resuming occupational or recreational activities e g after M I or cardiac surgery Clinical and epi2. gt buttons Push ENTER again to save and exit e The default for pacer detect is OFF It must be turned ON for each procedure in which it will be used Date Time For setting the date and clock To set the clock press ENTER for set mode To change fields push the A and V buttons To change values push the lt and gt buttons Push ENTER again to save and exit About Unit information and Copyright notice Start After configuring or reviewing all the settings select the start screen and push the ENTER button This will start the recording Vision 5L Holter Recorder Recording Display The Vision 5L displays the current time and the remaining recording time Patient Event Marker To register an event push the ENTER button Early Out and Real Time ECG Display Hold the 4 arrow button and the ENTER button simultaneously to access the menus for Early Out and Real Time Display The Early Out feature allows a trained individual to stop a recording before the selected recording time has elapsed When viewing the Real Time Display the user can return to the recording screen manually or the Vision 5L will automatically return after five minutes have elapsed Real Time mode does not interrupt recording Caution Do not remove CompactFlash card or battery until session is complete or Early Out procedure is finished Session Complete Remove the CompactFlash card disconnect the patient l
3. 7 3 100 12 12 23 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 NOTE1 At 80 MHz and 800 MHz the separation distance for 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 19 Vision 5L Holter Recorder Vision Series Holter Analysis Systems PC Card Compat 92500 92501 92502 92503 The Vision 5L CompactFlash card is only compatible with the following Vision Series Holter Analysis Systems Windows 2000 Professional Windows 98 2nd Edition Windows XP Professional e e e systems and is not appropriate for use with any other system or The CompactFlash card is guaranteed for use only in the above computer UjA uey ssa aq pinoys suiBuads PRY ZHIN Os 01 2HY 0S1 sBuei Aousnbag Sup Je D 18 uoisiA aui Bune o a4 Jo Bugueuioal se uns Aresse eu etr Aew seJnseeul jeuonippe peaasqo si a2ueuuojiad puuouge J uogejedo ewou Ajuaa 0 pe lesqo aq pinoys 15 uoriA eu UA a oqe snd eoueijduico Jy ajge ridde ay spaa2xe pesn si 15 uoislA aui uorues Ul uone20 auj ui ujBuags
4. N CARDIAC a J SCIENCE Bothell Washington 98021 8969 608 764 1919 Operating Instructions Vision 5L Digital Holter Recorder Document Number 010 1646 00 Revision H Caution U S Federal law restricts this device to sale by or on the order of a physician Copyright 2005 Cardiac Science Corp C All rights reserved ri Authorized Representative Manufactured for per MDD 93 42 EEC Cardiac Science Corp MDSS 3303 Monte Villa Parkway Bur k ardtsirasse 1 Bothell Washington 98021 8969 D 30163 Hannover Germany 800 426 0337 or 425 402 2000 Vision 5L Holter Recorder Recommended Separation Distances Refer to the following table for recommended separation distances between the Vision 5L and portable and mobile RF communications equipment The Vision 5L is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the Vision 5L can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Vision 5L as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to output power of frequency of transmitter transmitter 150 kHz 80 MHz 800 MHz to 80 MHz to 800 MHz to 2 5 GHz w d 12YNP d212NP d 2 3VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8
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6. demiological research studies Evaluation of patients with pacemakers Reporting of time and frequency domain heart rate variability 8 Reporting of QT Interval noo Vision 5L Holter Recorder EMC Declaration Tables WARNING Use of accessories or cables other than those specified with the exception of Burdick accessories and cables sold by Cardiac Science Corp as replacement parts for internal components may result in increased emissions or decreased immunity of the Vision 5L CAUTION The Vision 5L requires special precautions regarding EMC Install and use the Vision 5L according to the guidelines of the EMC declaration tables CAUTION Portable and RF communications equipment may affect the Vision 5L Always observe the recommended separation distances as defined in the EMC declaration tables The Vision 5L is intended for use in the electromagnetic environment specified below The customer or the user of the Vision 5L should assure that it is used in such an environment 15 oO NOOB Vision 5L Holter Recorder 3 Channel 7 lead Electrode Placement Seven color coded leadwires are utilized to create a 3 channel ECG recording A L 7 Lead Electrode Placement Channel Color 1 White 1 Red 2 Black 2 Brown 3 Blue 3 Orange Reference Green Placement Below left clavicle just lateral to the midclavicular line At the fourth rib to the left of the sternal border Below right clavicle j
7. eads from the electrodes and dispose of the electrodes The patient cable connector can remain connected to the Vision 5L for the next procedure Remove and properly dispose of the alkaline battery according to local laws Analyzing the ECG Data Insert the CompactFlash card into the card reader of the Vision Series system on which the ECG analysis is to be performed Once the data transfer is complete the previous patient s name and any other information written on the CompactFlash card s label should be removed Be sure to initialize the CompactFlash card prior to next use Vision 5L Holter Recorder Service amp Maintenance Maintenance Cleaning Dampen a soft cloth with mild detergent and water to clean the recorder lead wires and belt clip Remove the battery before cleaning the recorder Service If there is a problem with the recorder review the problem descriptions and solutions listed below If additional assistance is required contact Cardiac Science Technical Support Contact Technical Support before returning a recorder to make shipping arrangements Phone 800 777 1777 608 764 1919 E mail techsupport cardiacscience com
8. en ete eer n etsi ee bu c ede e eT Ea 2 Indications for Use eee tenente een tenentis 2 md z07 I i o o PRESE TRE 4 Electrode Application sss 5 enIciuILMMM 6 Initialize the CompactFlash Card ssssssesses 6 HoWw to ROCOFGd it et REGEM RR ERR IER A 6 Recording Display eene neret pe ener eden 8 Patient Event Marker eese eren ntnns 8 Early Out and Real Time ECG Display sees 8 Session Complete ssssssssssssseeeeeeneenm 8 Analyzing the ECG Data sss eee 8 Service amp Maintenance eese eene nnne nnne 9 Maintenarice 2 cucciolo e i dod eee 9 Gleanlhg e perd UE e ei DI nii 9 SENICE cuite id bb eru mb nter ds 9 Troubleshooting te a 10 Service Items amp Accessories ssssssseeeeee 11 Specifications sieren a iaa vana danena cte ca ree nananana eaaa anana 12 Electrode Placement essent nennen nennen 13 3 Channel 5 lead Electrode Placement ssssss 13 3 Channel 7 lead Electrode Placement sssss 14 EMC Declaration Tables eese 15 Electromagnetic Emissions sss 16 Electromagnetic Immunity esee 16 Recommended Separation Distances sssssssss 19
9. idity Battery Type Life Removable CompactFlash Non volatile 200 sec 0 05Hz to 60Hz 3dB LCD display 24 or 48 hours Non volatile Flash Memory 128MB Removable 3 75 x 3 00 x 0 90 95 x 76 x 23mm 4 oz 114 grams Molded plastic UL 94V 0 Any orientation 1X 20 pin 5 or 7 lead 0 C 32 F to 45 C 113 F 20 C 4 F to 65 C 149 F 10 to 95 non condensing 5 to 95 non condensing 1 AA Alkaline IEC LR6 48 hours 12 absolutely essential for obtaining a quality ECG recording Refer to your electrode provider for instructions on skin preparation techniques Apply electrodes per Electrode Placement diagrams on page 13 in this manual or as instructed by the physician Vision 5L Holter Recorder Operation Initialize the CompactFlash Card Refer to the Operating Instructions of your Vision Series system for the initialization procedure NOTE The Vision 5L Holter Recorder is only compatible with the CompactFlash card provided part number 010 1640 00 The CompactFlash card is exclusively for use with the Vision 5L Holter Recorder and is not compatible with other Holter recorders CAUTION CompactFlash card must be initialized prior to recording Otherwise ECG data from previous recording is retained How to Record 1 Install initialized CompactFlash card observing correct insertion direction and method It is recommended that the CompactFlash card be installed first bef
10. or other sources of electromagnetic interference such as electric blankets heating pads etc Vision 5L Holter Recorder Electrode Placement 3 Channel 5 lead Electrode Placement Five color coded leadwires are utilized to create a 3 channel ECG recording 5 Lead Electrode Placement Channel Color Placement 3 White Below right clavicle just lateral to the midclavicular line 1 2 Red Top of the sternum 2 3 Black Eighth rib at the left midclavicular line 1 Brown Fifth rib at the left anterior axillary line Reference Green Eighth rib at the right midclavicular line NOTE BROWN RED Channel 1 BLACK RED Channel 2 BLACK WHITE Channel 3 13 Vision 5L Holter Recorder Vision 5L Holter Recorder Specifications Electrode Application e It is recommended that trained medical personnel Functional handle the application of electrodes Channels 3 e Use only electrodes designed for longer term Resolution 8 10 bit sampling 4X Oversampling Holter monitoring Programmable e Proper preparation of the patient s skin is Recording Full disclosure Download interface Sample rate Frequency response Signal verification Pacemaker Detection Memory Recording time Type Capacity Physical Dimensions Weight with batteries Enclosure Operating position Electrical Gain settings Connector Patient cable Environmental Operating temperature Non operating temperature Operating humidity Non Operating hum
11. ore installing the battery 2 Install fresh AA alkaline battery in the Vision 5L Be sure to observe the correct battery polarity 3 Hook up the patient to the device via the patient cable CAUTION Insert the patient cable in the orientation as shown in the picture on page 2 The patient cable will require a very firm squeeze on the locking clip of the cable plug in order to install or remove it from the Vision 5L However it only needs to be removed in the event of damage Vision 5L Holter Recorder Service Items amp Accessories Description Part Number 128 MB CompactFlash Card 010 1640 00 3 Channel Recorder Prep Kit 043250 with 5 electrodes 3 Channel Recorder Prep Kit 043272 with 7 electrodes 5 Lead Patient Cable 010 1642 00 7 Lead Patient Cable 010 1643 00 Pouch with Strap 010 1644 00 Belt Clip 010 1645 00 Operating Instructions 010 1646 00 NOTE The Vision 5L Holter Recorder is only compatible with the CompactFlash card listed above The CompactFlash card is exclusively for use with the Vision 5L Holter Recorder and is not compatible with other Holter recorders 11 Troubleshooting Vision 5L Holter Recorder Symptom Recommended Solution No display Ensure patient cable is connected Ensure battery is inserted with correct polarity Install new alkaline battery Low battery Inspect battery compartment clean contacts if necessary Install new alkaline ba
12. ttery Battery does not last 24 or 48 hours Ensure new alkaline battery is being used Noise artifacts on ECG signal Ensure all electrodes are securely attached to the patient Replace the patient cable 10 Vision 5L Holter Recorder To turn on the recorder push any one of the keypad buttons A splash screen will be displayed for a couple seconds then the trace screen will be displayed The device will not turn on unless a cable is plugged in 4 Push the lt 4 and gt keypad buttons to change the active screen To input Patient ID choose Input Patient ID from the proper screen Scroll Numerical line for Patient ID using 4 gt A and V buttons ENTER button selects each entry of Patient ID It is recommended that after the patient hook up is complete the device be inserted in the Vision 5L pouch to be worn by the patient either on the belt or with the shoulder strap Screen Description Trace Displays the signal trace in real time pacer pulse marks if selected There is one screen for each ECG channel e The gain setting is the same for all channels e Pacer pulse marks are displayed below the trace to indicate each pacer pulse detection Settings For setting the record time user language LCD contrast To change settings press the ENTER button for set mode To change fields push the A and V buttons To change values push the lt and
13. ust lateral to the midclavicular line Fifth rib at the left anterior axillary line At manubrium sterni Sixth rib at the left midclavicular line Lower right chest wall rib 14 Vision 5L Holter Recorder Recorder Components LCD Display Patient Cable Vision 5L Holter Recorder Equipment Symbols Symbol Description Type B equipment ZV Consult manual Complies with the Medical Device 0086 Directive of the European Union ao Year of Manufacture SN Serial Number REF Catalog reorder number A TERTE Complies with the North American ETL ID safety standards Listed Precautions Patient leads must be removed from electrodes before defibrillation When using Pacer Detect the physician should be aware that false positive and false negative pacer detects may occur False positives may result from poor electrode hook up or high noise conditions False negatives may occur with bipolar pacers due to a weak pacer pulse signal at the patient s skin surface When reviewing ECG data the presence of pacemaker signals in the ECG trace should not be considered true representations of the actual pacemaker stimulus amplitude Observe local laws for disposal of alkaline batteries Do not leave the batteries in the recorder when it is not in use Damage from corrosion could result For the best recording results the patient should be instructed to avoid close proximity to heavy electrical equipment
14. y 00018 23l Ji Payeipey 9 F 00019 23l dy papnpuog 17 Vision 5L Holter Recorder Electromagnetic Emissions Emissions Electromagnetic Compliance 3 test environment guidance RF emissions Group 1 The Vision 5L uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Vision 5L is suitable for use in CISPR 11 all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Electromagnetic Immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If eal eal floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz magnetic field IEC 61000 4 8 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 16 Vision 5L Holter Recorder Table of Contents OVOfVIQW fcc 5 2 cies ecir cierto hti ote cepi tere DR pe t eterne ipei teer een 2 Description in dte r
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