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Tremitas GmbH

Schleppe-Platz 5

A - 9020 Klagenfurt

www.tremitas.com

TPHL004E

Содержание Tremipen

Страница 1: ...Instructions for Use Tremipen Home for the 1304 EN...

Страница 2: ......

Страница 3: ...Tremipen Home is in compliance with the Directive MDD 93 42 EEC and the Austrian medical device law BGBI 657 1996 The CE label on the device documents the accordance to this The full text about the D...

Страница 4: ...4 Tremor Amplitude Power of Main Peak 11 4 1 5 Medical Decisions based on Tremipen 14 4 2 User Training Knowledge 15 4 3 Medical Indications 15 4 4 Where how long and how often should the Tremipen be...

Страница 5: ...4 22 Correct Waste Disposal 24 4 22 1 Disposal of Packaging Waste 24 4 22 2 Disposal of the Tremipen 24 5 Performance and Technical Data 26 5 1 Changes of Technical Data 26 5 2 Rules Laws and Standard...

Страница 6: ...e Tradename Tremipen Home also Tremipen Home by Tremitas Tremipen 2 1 2 Reference to Variants There are different variants of Tremipen e g Tremipen Home Tremipen 2 1 3 Reference to allowed Accessories...

Страница 7: ...Tremipen Case 4 Grip recess 2 Power switch ON Button 5 Battery case 3 Display 6 Battery 3 Intended Use Purpose 2 2 Legal Manufacturer of the Tremipen Tremitas GmbH Schleppe Platz 5 Klagenfurt A 9020 A...

Страница 8: ...rect or improper use of the Tremipen Tremipen is NOT a toy keep away from children Tremipen must only be used as described in this IfU The ON Button of the Tremipen is a small part which could be swal...

Страница 9: ...the Tremipen 6 After 30 seconds the Tremipen automatically turns off and is ready for another measurement 7 The Tremipen can be manually shut down by continuously pressing the ON button for 3 seconds...

Страница 10: ...on during the whole measurement process 1 Hold the Tremipen as described above 2 Extend your arms horizontally forward in a 90 angle with straightend and lowered shoulders as seen in the picture above...

Страница 11: ...n the arms are positioned just like wings as seen in the picture above 3 The hands are held in front of the upper body slightly below the chest the fingertips of both hands should be close to each oth...

Страница 12: ...display shows a countdown 5 4 3 2 1 The Tremipen is in measurement mode this is shown with a progress bar The tremor amplitude is shown it consists of a two to four digit number followed by the unit m...

Страница 13: ...he Tremipen measures accelerations mG is currently used more often than mV Nevertheless it is possible to convert the values To better understand the relations between the mG unit and the tremor ampli...

Страница 14: ...12...

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Страница 16: ...n are NOT meant to be used for diagnostic or therapeutic purposes by users who are not medical experts This applies for the following but not exclusive list of situations Self diagnosis without a medi...

Страница 17: ...vel impairment G20 1 Primary Parkinson Syndrome with moderate or high level impairment G25 0 Essential Tremor G25 2 Other not further specified forms of tremor Additionally tremor as a symptom The Tre...

Страница 18: ...incorrect use of the Tremipen Attention The Tremipen must only be used under the following environmental conditions Otherwise it could damage the device or lead to wrong measurement results 10 C to 3...

Страница 19: ...gned packaging Keep the Tremipen away from children The Tremipen must only be transported within the provided packaging If the Tremipen is not stored within the recommended environmental conditions de...

Страница 20: ...ttery case 3 Insert the enclosed battery correctly and carefully pay attention to polarity The positive pole of the battery must face to the display 4 Close the battery case Attention do not bruise yo...

Страница 21: ...tery needs to be replaced 4 11 Connections with and to Main Power Supplies 4 10 2 Battery Usage and Changing 4 10 3 Typical Battery Lifespan 4 10 4 Controlling the Battery Status The battery has a lif...

Страница 22: ...ons and compatibilities with other products and devices will be announced on www tremitas com The Tremipen is a stand alone device and is not intended to be used in combination with other products and...

Страница 23: ...lishments This also includes domestic establishments and establishments that are directly connected to a low voltage power supply network for private purposes Test Frequency Ranges EN 55032 B RF Inter...

Страница 24: ...ibutor if assistance is needed 4 18 Retesting The Tremipen was tested following the valid and applicable EMC guidelines The test report with No PB19G599 from 17 09 2019 was issued by Accredited Test L...

Страница 25: ...site www tremitas com or contact your local Tremipen distributor 4 19 Inspection Reevaluation Keep the Tremipen away from dust fuzz pets vermins and children to prevent staining Use non aggressive sur...

Страница 26: ...te electrical and electronic equipment and per country specific rules and guidelines the following rules apply 4 22 2 Disposal of the Tremipen Recycle the packaging as waste paper Otherwise not recycl...

Страница 27: ...iately decommissioning the Tremipen you contribute to an effective use of natural resources You will receive information about suitable waste collection centers from your local municipality from publi...

Страница 28: ...rage 150 measurements if more are made then the oldest ones are over written Measurement Range Tremor frequency 3 20Hz Tremor amplitude 10 1750mG Tolerance Ranges Tremor frequency 10 absolute toleranc...

Страница 29: ...he Tremipen must only be used within the environmental conditions described in this IfU Otherwise this could lead to wrong measurement results The Tremipen is NOT a toy Keep it away from children due...

Страница 30: ...isinfect the case of the Tremipen regularly and appropriately as described within the IfU to avoid infections If the Tremipen breaks due to mechanical impacts pay attention to sharp edges In such a ca...

Страница 31: ...ars after its first use An inspection reevaluation is necessary due to aging components and possible inaccuracies of the sensor This could lead to wrong measurement results Do NOT try to change and or...

Страница 32: ...o read and to store the Instructions for Use IfU This symbol informs to pay attention to the polarity of the battery This symbol provides information about the protection against electric shocks This...

Страница 33: ...ly decommission and recycle the packaging materials This symbol provides information about the operating temperature This symbol provides information about the operating humidity This symbol provides...

Страница 34: ...an activated technical self diagnosis mode do not use it Instead contact your local Tremipen distributor 32 This symbol informs about Bluetooth or other wireless transmissions This symbol informs that...

Страница 35: ...ms via Bluetooth after each measurement the Bluetooth mode can be completely deactivated Quickly press the ON button three times in a row if the following symbol can be seen For more information about...

Страница 36: ...n the IfU Contact the Legal Manufacturer Contact a doctor The Tremipen cannot be activated after a battery change Empty battery inserted Battery inserted wrongly Device did not receive enough power In...

Страница 37: ...available in the following reference languages Feb 03rd 2020 GERMAN ENGLISH Further and new languages will be announced on www tremitas com 14 Information about Safety Reports A safety report and a s...

Страница 38: ...e contact the local distributor for Tremipen products Hotline 43 660 55 10 380 Website www tremitas com 18 Warranty and Contact Please see page 1 of this IfU 17 CE Label 36 19 Local Tremitas Partner F...

Страница 39: ...Notes 37...

Страница 40: ...Notes 38...

Страница 41: ...39...

Страница 42: ...Tremitas GmbH Schleppe Platz 5 A 9020 Klagenfurt www tremitas com TPHL004E...

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