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Tremitas Tremipen, Instructions For Use Manual

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We, the Tremitas GmbH, declare in sole responsibility 

as the Legal Manufacturer, that the medical device

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 Declaration of Conformity is 

available on our website: www.tremitas.com

Declaration of Conformity

1304

Summary of Contents for Tremipen

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

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 14: ...12...

Page 15: ...13...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 39: ...Notes 37...

Page 40: ...Notes 38...

Page 41: ...39...

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

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