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1.

INTRODUCTION

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USE IN THE UNITED STATES

USA

only

[CAUTION:

Federal law restricts the sale of this device by or on the order of a physi-

cian.]

1.1.

1. INTRODUCTION

SpiderView – UA10709B

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Содержание SpiderView

Страница 1: ...SpiderView Digital Holter Recorder USER MANUAL...

Страница 2: ......

Страница 3: ...ckaging 12 Opening the battery cover 13 Cable insertion and extraction 13 7 USE OF BATTERIES 14 Batteries 14 Rechargeable batteries 14 Internal memory battery 14 8 POSITIONING THE ELECTRODES 15 Two ch...

Страница 4: ...Radio Equipment Emission 33 14 ACCESSORIES 34 15 APPENDIX 35 Guidance and manufacturer s declaration electromagnetic emissions 35 Guidance and manufacturer s declaration cable length 35 Guidance and m...

Страница 5: ...alerts you to a hazard that may result in equipment damage or personal injury Carefully read the instructions provided with this icon USE IN THE UNITED STATES USA only CAUTION Federal law restricts t...

Страница 6: ...nd SyneCom TYPE OF RECORDING SpiderView offers three types of recording Holter recording only High Resolution ECG recording only High Resolution ECG recording followed by a 24 hour standard Holter rec...

Страница 7: ...ulatory authority Training completion and effectiveness are under his her medical supervisor s responsibility NOTE Any serious incident that has occurred in relation to the device must be reported to...

Страница 8: ...060 hPa Storage and Transportation 20 to 65 C 5 to 93 non condensing 500 hPA to 1060 hPa Flash cards 8 If exposed to a severely wet or humid environment a protective bag like RG008 is needed During tr...

Страница 9: ...ore starting an MRI procedure CARE OF THE DEVICE AND FLASH CARD No special maintenance is required The external case and the patient cables can be cleaned with a slightly damp cloth or a wet soapy clo...

Страница 10: ...ty is only valid under the condition that no attempts have been made to open or repair the device The warranty will be void if the device or the cards have been used contrary to this user manual s rec...

Страница 11: ...DESCRIPTION SPIDERVIEW COMPONENTS 2 Screen buttons 3 Cursor buttons 4 Event button 5 LCD display 6 Operating light LED 1 On off button 7 Patient cable connector 6 1 6 GENERAL DESCRIPTION SpiderView UA...

Страница 12: ...ith this symbol Consult instructions for use available on CD ROM Consult the documentation and manual enclosed in the packaging On Off switch CE mark SpiderView complies with EC directive 93 42 EEC Se...

Страница 13: ...e cover with the thumb as shown below CABLE INSERTION AND EXTRACTION The insertion first A then B and extraction first C then D of the patient cable should be done as indicated in the picture below NO...

Страница 14: ...will be one day only 24h regardless of the programmed time RECHARGEABLE BATTERIES For 24 hour recordings SpiderView may also be powered by a re chargeable battery with a minimum capacity of 1500 mA h...

Страница 15: ...attached to avoid air bubbles which could impede proper contact A loop should be made in each lead and the lead then attached with adhesive strips close to the electrode Pressure on an electrode coul...

Страница 16: ...ength 122 cm ELECTRODE PLACEMENT The CMV5 lead 60 axis detects identifiable P waves and high amplitude QRS complexes It is also acknowledged as being sensitive in detecting myocardial ischemia during...

Страница 17: ...o leads used for a two channel recording CBV2 is an anteroposterior lead close to the Z axis that allows thorough study of changes in the ST segment related to the left coronary artery as well as the...

Страница 18: ...ver 8th rib in right midclavicular line Cable length 152 cm Available with SyneScope Holter software ELECTRODE PLACEMENT For an ambulatory orthogonal ECG recording close to the XYZ late potential conf...

Страница 19: ...avF augmented limb leads Leads V1 to V6 precordial leads The central terminal of Wilson is automatically calculated by SpiderView Because of ambulatory conditions we recommend placing electrodes on t...

Страница 20: ...ack of the device under the back cover NOTE The event button has a flat surface in order to avoid accidental activation of the button and causing false patient events in the report After switching on...

Страница 21: ...rd is not correctly inserted the cover of the case cannot be closed WARNING SpiderView has been designed to fully support flash cards with NAND technology Older MMC cards with NOR technology do not gu...

Страница 22: ...els should be at least 1 mV This corresponds to the amplitude of the calibration bar on the left side of the display Pacemaker recordings If the patient undergoing a Holter recording has a pacemaker i...

Страница 23: ...rt patient ID and activate the accelerometer sensor In this screen the ECG analysis protocol can be selected with or without activating the accelerometer sensor Adult Normal analysis protocol Infant F...

Страница 24: ...o the flash card and the cable used here you can select the recording quality and the recording duration Duration longer than 24h available with SyneScope Holter software Please refer to the table in...

Страница 25: ...this mode has been selected in the mode choice screen the recorder is going to perform a short high resolution recording 20 minutes by default followed by a 24h Holter recording or longer The device w...

Страница 26: ...ARNING Removing the flash card or the battery while the device is recording or stopping the device with any other method than those described in this paragraph may damage the data on the card and may...

Страница 27: ...1400 min 23h20min 520 min 8h40min 512 MB FLASH CARD duration in days d Nbr of channels 2 3 ABC or XYZ 9 12 STD 4 d 4 d HR 4 d 4 d Enh 4 d 4 d HR 4 d 2 d No Comp 7 d 3 d HR 2 d 1 d High resolution only...

Страница 28: ...shows four or six vertical bars according to the cable in use Each bar is an indicator of the contact quality of an electrode If the height of one bar does not reach the dotted line placed at the mid...

Страница 29: ...me and Date are stored on the device and kept updated by the internal rechargeable battery for about a week After switching on the recorder if the SpiderView fails to retrieve the language time or dat...

Страница 30: ...st error that occurred and the time and date of the occurrence by switching the device on 1 and keeping the left cursor button 3 pressed until the end of the auto test phase The Critical error screen...

Страница 31: ...le creating file errlog 0402 Overrun on acquisition buffer 1 0115 Error while writing file errlog 0403 Overrun on acquisition buffer 2 0116 Error while creating file media 0117 Error while writing fil...

Страница 32: ...Common mode rejection 94 dB Input dynamic range 16 mV Power supply One 1 5 V AA long life lithium battery for seven 24 hour recordings or one NIMH type rechargeable batteries with a minimum capacity o...

Страница 33: ...ter and the signal has an excellent quality as long as there is not much noise 10MB channel 24h In uncompressed mode NoComp there is no compression which means that files can be very large 17 3 MB cha...

Страница 34: ...View 10 electrodes 12 channels RC016 ECG Cable SpiderView 5 electrodes 2 channels RC017 ECG Cable SpiderView 7 electrodes 3 channels ABC RC019 ECG Cable SpiderView 7 electrodes 3 channels ABC XYZ and...

Страница 35: ...er must therefore be strictly observed The medical device must not be used near or on another device If this cannot be avoided it must be checked for proper operation under the conditions of use befor...

Страница 36: ...ed for use in the electromagnetic environment specified below The customer or the user of the SpiderView should ensure that it is used in such an environment Immunity test IEC 60601 test level Complia...

Страница 37: ...care environment or profes sional health care establishment If operation of the system requires continued use during power cuts it is recommended that the medical device be powered by a separate powe...

Страница 38: ...y RF fields IEC610004 6 3 V 150 kHz to 80 MHz 80 MA at 1 KHz 6 V in ISM band between 0 15 MHZ and 80 MHZ Ra dio Amateur band in cludes 80 MA at 1 KHz 3 V 150 kHz to 80 MHz 80 MA at 1 KHz 6 V in ISM ba...

Страница 39: ...osure rules This equipment has very low levels of RF energy that is deemed to comply without testing of specific absorption rate SAR Cet appareil contient des metteurs r cepteurs exempt s de licence c...

Страница 40: ...ption which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one of the following measures Reorient or relocate the receiving antenna...

Страница 41: ......

Страница 42: ...MicroPort CRM S r l Via Crescentino S N 13040 Saluggia VC Italy Tel 39 0161 487095 www microport com 2021 11 UA10709B...

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