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General Information

GBA 17.10.002-05
Instructions for use TELESMART-H/P Holter-ECG-Recording System version D
Version 5
Revised 2013-07

GBA-TS_HP-D-EN.odt

©

 Medset Medizintechnik GmbH

Medset, PADSY, CARDIOLIGHT, SCANLIGHT, Spirosound, Ergotop are registered trade 
marks of Medset Medizintechnik GmbH. 
All other trade marks are the property of their respective owners.

Medset Medizintechnik GmbH
Curslacker Neuer Deich 66
D-21029 Hamburg
Germany
Telefon: +49(0)40 / 72 58 22-0
Telefax: +49(0)40 / 72 58 22-11

http://www.medset.com

email:

//[email protected]

Содержание PADSY TELESMART-H/P

Страница 1: ...I N S T R U C T I O N S F O R U S E English TELESMART H P Holter ECG Recording System Version D PADSY Holter We have sound ideas EN EN...

Страница 2: ...s manual must always be kept with the equipment and accessible to all users All rights particularly translation rights to the text and illustrations are reserved All manner of reproduction is permitte...

Страница 3: ...zintechnik GmbH Medset PADSY CARDIOLIGHT SCANLIGHT Spirosound Ergotop are registered trade marks of Medset Medizintechnik GmbH All other trade marks are the property of their respective owners Medset...

Страница 4: ...nt are visually emphasized by the adjacent graphic symbol Follow instructions for use Caution consult accompanying documentation Safety precautions need to be observed that are not stated on the produ...

Страница 5: ...General Information Products marked with this symbol must not be treated as normal household waste The number printed next to this symbol corresponds to the product s serial number...

Страница 6: ...ing patient cable 3 for pacemaker patients 21 4 3 Starting an ECG recording 22 4 3 1 Recorder direct start procedure 22 4 3 2 Starting the recorder with PADSY 23 4 3 3 External start 25 4 4 Patient in...

Страница 7: ...Page 7 9 1 Accessories 40 9 2 Consumables 40 TELESMART H P Holter ECG Recording System version D...

Страница 8: ...als who either carry the TELESMART H in its recorder bag during their everyday activities or leave it stationary to make single recordings up to 7 days in length Once a recording is made the memory ca...

Страница 9: ...des must be removed from the patient Please note that the conductive sections of the electrode cables must not be allowed to contact any electrical equipment electrical sockets conductive or grounded...

Страница 10: ...equipment If TELESMART H P is operated using lithium batteries only batteries according to DIN EN 60086 4 may be used Otherwise there is an increased risk of hazardous excessive heat generation Liqui...

Страница 11: ...or by any other reason not accessible by the user of the system the documents must be ordered at Medset for replacement and made available to the user in order to ensure safe operation This also inclu...

Страница 12: ...patient can use this button to mark specific events that will be saved to the memory card and will be visible on the ECG after it has been evaluated using the software To do this the patient must bri...

Страница 13: ...mands and error messages that occur during recorder operation are dis played Acoustic signals System start boot loader After Medset Logo appears System test successful Recorder start successful Keystr...

Страница 14: ...up it is recommended that a brief check be performed as described in the Operation testing section 3 1 Special hints for setting up the device with MacOS X Please note that on newer MacOS X operating...

Страница 15: ...uring the system start a progress bar may be seen at the lower edge of the screen 6 If something not described above occurs please see chapter 2 and 6 in this user s manual Please instruct your patien...

Страница 16: ...T H recorder was validated for use with the following electrodes ARBO H92SG as standard electrodes only suitable for 24 hour use Medicotest BlueSensor VL 00 S that prevents the movement of the electro...

Страница 17: ...e always connect the patient cable to your TELESMART recorder before you apply the cable with electrodes to the patient For removal of the recorder from the patient please disconnect first the electro...

Страница 18: ...line red 1 Right clavicle at sternal border Channel B modified V6 white 6 Left fifth intercostal space in the anterior axillary line yellow 2 Left clavicle at sternal border Channel C modified V2 oran...

Страница 19: ...dified CC5 green 3 white 2 Green 3 Left fifth intercostal space in the anterior axillary line Red 1 On the sternum level with the first intercostal space White 2 Right fifth intercostal space in the a...

Страница 20: ...ed on the ECG with a red marker element Please refer to the PADSY Holter software user s manual for more detail Please note that patient cable M is not intended for use with pacemaker pa tients 4 2 1...

Страница 21: ...acemaker operation For patients with mixed pacemaker operation unipolar detection and bipolar stimu lation the electrode array must be established identically to how it was for pa tients with bipolar...

Страница 22: ...ting No returns to the previous menu existing recording Selecting Yes deletes the existing recording and displays the following Patient s name To record audio please press and hold Micro Micro Next Us...

Страница 23: ...th two beeps A dead time is maintained between two markers where no additional markers can be added The recording will be stopped after the specified time if a low voltage condition ex ists if the mem...

Страница 24: ...s displayed Connected with PADSY Computer Doctor Back Selecting Back or if the connection is lost brings the user back to the entry menu The PC displays the recorder assistant that guides the user thr...

Страница 25: ...isplays the current ECG signal Back Start A Back returns the user to the Recorder ready screen The A allows the channel to be selected The recording is started with the Start button 4 4 Patient instru...

Страница 26: ...ime for approx 5 seconds The following menu appears Recording running Duration 00 03 05 Back End Online When this menu is displayed the recording is running in the background To see the ECG signal pre...

Страница 27: ...tions for use of the rechargeable batteries 4 7 2 Battery compartment Using gentle pressure on the grip molding of the battery compartment cover will al low the cover to be opened The battery is now v...

Страница 28: ...4 Recorder bag The recorder bag protects the recorder as well as allows it to be comfortably car ried The recorder bag can be secured to the patient using the nylon strap TELESMART H P Holter ECG Reco...

Страница 29: ...contact with disinfectants During cleaning and disinfection ensure that no liquid enters the openings in the equipment Cables and leads may not be autoclaved for sterilization this may compromise the...

Страница 30: ...cation Patient cable with a length of 75cm Following disinfectants are adequate for disinfecting electrode leads of the patient cable Terralin Protect Sch lke und Mayr Hexaquart Forte B Brown Sterill...

Страница 31: ...The equipment undergoes extreme mechanical stress Liquid enters the equipment housing Cables plugs or the housing is damaged Name plate or parts of technical documentation is damaged or unreadable Enc...

Страница 32: ...years Undamaged patient cables are specified for a service lifetime of at least 1 years Memory cards are specified for a service lifetime of at least 2 years at daily use Please exchange the memory ca...

Страница 33: ...t inserted properly or is missing Insert or check the position of the memory card to ensure that it is properly connected Patient cable missing Patient cable not supported The electrode cable is not p...

Страница 34: ...d or incorrect electrodes were used or the skin surface was not appropriately prepared 3 Defective electrode lead 1 Carefully replace electrode 2 Use only electrodes and materials recommended in the u...

Страница 35: ...care env EN 60601 1 11 Electrical Data Number of ECG channels 3 time synchronized differential inputs Input resistance 10 M Ohm 22nF Sensitivity 7 mV System noise 46 V p p DC stability 300 mV Frequenc...

Страница 36: ...umidity 10 bis 95 without condensation air pressure 700 1060 kPa Variants TELESMART H max recording time 7 days Channels cable 2 channels with patient cable 2 2L 3 channels with patient cable 3 3 chan...

Страница 37: ...supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Guidance and manu...

Страница 38: ...es m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey1 should be less than the compliance level in each frequency range NOTE 1 At 80 MHz and 800 MHz the highe...

Страница 39: ...maximum output power of transmitter in W 0 01 0 1 1 10 100 80 MHz to 800 MHz d 1 17 sqrt P 0 12 0 37 1 17 3 70 11 70 800 MHz to 2 5 GHz d 2 33 sqrt P 0 23 0 74 2 33 7 37 23 30 150 KHz to 80 MHz not ap...

Страница 40: ...system please note recorder version in order 9 2 Consumables Order code Item description BAV0004 ARBO Holter ECG electrodes type H92SG 48x34 mm with special solid gel only for 24 hr use BAV0014 Singl...

Страница 41: ...Page 41 TELESMART H P Holter ECG Recording System version D...

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