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Table of Contents
Summary of Contents for Tremitas Tremipen Home
- Page 1 Instructions for Use for the Tremipen® Home 1304...
- Page 3 Declaration of Conformity 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.
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Page 4: Table Of Contents
1. Table of Contents 1. Table of Contents 2. General Information 2.1 General Information about the Product 2.1.1 Name – Tradename 2.1.2 Reference to Variants 2.1.3 Reference to allowed Accessories 2.1.4 Safekeeping of the IfU 2.1.5 Scope of Delivery | Parts of the Device 2.2 Legal Manufacturer of the Tremipen®... - Page 5 11. Possible Error Causes and Solutions 12. Definition of Color Coding and Identifying Colors 13. Special Exclusions 14. Information about Safety Reports 15. Reference to Clinical Performance 16. Allowed Languages for this IfU 17. CE-Label 18. Warranty and Contact 19. Local Tremitas Partner...
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Page 6: General Information
Not following the IfU will lead to a warranty loss. 2.1.1 Name – Tradename Tremipen® Home (also Tremipen® Home by Tremitas, Tremipen®). 2.1.2 Reference to Variants There are different variants of Tremipen® (e.g. -
Page 7: Legal Manufacturer Of The Tremipen
(4) Grip recess 2.2 Legal Manufacturer of the Tremipen® Tremitas GmbH Schleppe-Platz 5 | Klagenfurt A-9020 | Austria www.tremitas.com | office@tremitas.com +43 660 55 10 380 2.3 Issue Date of the IfU Date of last revision: Feb 03rd 2020 Version Number: 1.0 Please contact your local Tremipen®... -
Page 8: How To Use The Tremipen® Safely
(by measuring the symptom on a regular basis) Tremitas GmbH does not take any responsibilities and liabilities for incidents, accidents, defects and/ or harms and damages, which occur due to a incorrect or improper use of the Tremipen®! Tremipen®... -
Page 9: Measurement Positions (Examples)
The Tremipen® must only be used with a closed battery case! For further information and instruction videos please visit our website www.tremitas.com. 4.1.1 Measurement Positions (Examples) The following rules apply for all measurement positions: The Tremipen® must be held with a loose grip, just like a regular pen, so that no physiological tremor can influence the actual tremor. - Page 10 How to hold the Tremipen® during a measurement Measurement Position for Rest Tremor (e.g. for Parkinson‘s Disease) Hold the Tremipen® as described above. Place your arms in a relaxed position onto your upper legs or onto armrests of a chair, as seen in the picture above.
- Page 11 The fingers on the hand, which does not hold the Tremipen®, should be spread out. Additionally, the ring finger and the little finger of the hand, which is holding the Tremipen®, should be spread away from the palm as far as possible. Remain this position...
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Page 12: Symbols On The Tremipen® Display
The following symbol is shown for all measurement results below 10mG and 3Hz (underflow): The following symbol is shown for all measurement results over 1750mG (overflow): All measurement results are beyond the measurement range of the Tremipen® if they are below 10mG and above 1750mG. -
Page 13: Tremor Amplitude (Power Of Main Peak)
(Nevertheless, it is possible to convert the values). To better understand the relations between the mG unit and the tremor amplitude, the Tremitas GmbH has used available clinical data from own clinical trials to create a comparison between the amplitudes defined in the “Unified Parkinson’s Disease Rating Scale”... -
Page 16: Medical Decisions Based On Tremipen
4.1.5 Medical Decisions based on Tremipen® The measurement results generated by the Tremipen® are clinical measurement results that can be be used within the intended purpose. Nevertheless, the results and the use of the Tremipen® are NOT meant to be used for diagnostic or therapeutic purposes by users, who are not medical experts. -
Page 17: User (Training, Knowledge)
4.2 User (Training, Knowledge) The Tremipen® is intended to be used by the patients themselves (lay person), since the intended functioning requires the patient to hold the object. Medical experts and professionals can assist during the preparation or the implementation of the intended operation. -
Page 18: Exclaimers
4.6 Exclaimers Exclaimers for incorrect use of the Tremipen® The Tremipen® must NOT be used by users, who are not able – in case of physical and/or mental impairments – to implement a correct measurement. In this case, the measurement must be supervised by qualified personnel or professionals. -
Page 19: Pressure
4.7.5 Pressure 700 hPa to 1060 hPa 4.7.6 Heights above the Sea Level Heights above the sea level are bound to the pressure described in chapter 4.7.5 4.8 Storage | Safekeeping | Transport • If you do not use the Tremipen® for a longer time, keep it safe within the provided packaging. -
Page 20: Installation | Battery Usage | Battery Changing
All performance characteristics and functionalities of the Tremipen® were only tested with this type of battery! The Tremitas GmbH is not liable for improper functioning or malfunctions of the Tremipen® due to the use of other battery types. If alternative batteries... -
Page 21: Battery Usage And Changing
4.10.2 Battery Usage and Changing Open the battery case of the Tremipen®. Optional: Carefully extract the old and/or empty battery if available! Carefully insert the new battery – pay attention to polarity! Close the battery case; take care not to bruise your fingers! 4.10.3 Typical Battery Lifespan The battery has a lifespan of approximately 3-4 months... -
Page 22: Combination | Compatibility With Other Products And Devices
Tremipen® and other devices should be observed to verify that they are operating properly. Future combinations and compatibilities with other products and devices will be announced on www.tremitas.com 4.13 Distance to RF Communications Equipment WARNING: Portable RF communications... -
Page 23: Electromagnetic Classification Of The Tremipen
4.14.1 Electromagnetic Classification of the Tremipen® The Tremipen® is classified as Group 1 (CISPR 11): It uses HF energy for internal functions only. Consequently, it is improbable that the Tremipen’s emissions will cause damages to nearby electronic devices. The Tremipen® is classified as Class B (CISPR 11): It can be used in all establishments. -
Page 24: Rf Properties
The test report with No.: PB19G599 from 17.09.2019 was issued by: Accredited Test Laboratory No. 185. For further information please contact the Tremitas GmbH or your local Tremipen® distributor. 4.15 Accessories The Tremipen® does not have any accessories. -
Page 25: Inspection | Reevaluation
Tremipen® is guaranteed by Tremitas GmbH. Inspection/reevaluation of the device is carried out by Tremitas GmbH – for further information visit our website www.tremitas.com or contact your local Tremipen® distributor. 4.20 Cleaning and Disinfection Clean the Tremipen®... -
Page 26: Decommissioning Lifecycle Of The Tremipen
• Do NOT dip the Tremipen® into cleaning agents! • If the Tremipen® is used by more than one user, it must be disinfected before every new user. 4.21 Decommissioning Lifecycle of the Tremipen® If the Tremipen® is decommissioned, the following steps must be implemented. - Page 27 Electronic waste (used devices) must NOT be decommissioned as residual waste. Otherwise such a decommissioning could lead to environmental harm. This symbol points out, that the Tremipen® must not be decommissioned as residual waste. This is required by the guideline for electrical and electronic equipment (2012/19/ EU) and by national laws about residual waste.
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Page 28: Performance And Technical Data
5. Performance and Technical Data Type Tremipen® Model Home See label on the packaging and the Lot Number Tremipen® 1.5V Power Supply (1 × 1.5 V Battery - Type AAA, Varta) IP Protection IP42 Category Weight approx. 30g including the battery approx. -
Page 29: Rules, Laws And Standards Applicable For The Tremipen
5.2 Rules, Laws and Standards applicable for the Tremipen® For a full list of applicable rules, laws and standards see the Declaration of Conformity within this IfU (page 1). 6. Adverse Effects and Residual Risks (MDD, Attachment I, Chapter 2) Adverse Effects: Based on previous clinical evaluations NO adverse effects were identified! Residual Risks: Based on previous clinical evaluations... - Page 30 Manufacturer or the local distributor! Do NOT remove the label on the Tremipen®! If the label is removed or lost, please follow the information within the IfU, on the packaging or online via www.tremitas.com. Otherwise, this could lead to a wrong use.
- Page 31 While changing the battery, take care of the correct polarity and of using the correct battery type with the correct voltage, as it is described within this IfU. Wrong battery types or too high or low voltages may cause a wrong measurement result and/or damages to the device.
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Page 32: Definition Of Symbols
8. Definition of Symbols This list of symbols applies to the IfU, the packaging and the labeling on the Tremipen®. Pay special attention / Use special caution. Situations events are strictly forbidden / prohibited. This symbol provides information about the Legal Manufacturer. - Page 33 This symbol describes that the device must not be decommissioned as residual waste. (Disposal of electronic equipment / electric waste) This symbol describes that the battery must not be decommissioned as residual waste. This symbol provides information about how to properly decommission recycle packaging materials.
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Page 34: Technical Self Diagnosis Function
This symbol informs about Bluetooth® or other wireless transmissions. This symbol informs that a direct current is used. This symbol informs that the Tremipen® must be protected against moisture and humidity. This symbol informs about the protection against solid matters (e.g. -
Page 35: Technical Bluetooth® Interface
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 future apps and connecting devices visit www.tremitas.com. -
Page 36: Possible Error Causes And Solutions
11. Possible Error Causes and Solutions Possible Causes Error Solutions of Error The Tremipen® can No battery inserted Insert a new battery not be switched on Empty battery Insert a new battery inserted Battery Pay attention to inserted wrongly polarity! The device is Contact the Legal damaged/defect... -
Page 37: Definition Of Color Coding And Identifying Colors
A safety report and a safety and risk analysis are available for the Tremipen®. For more information about these documents, which are part of the product development file, please contact the Tremitas GmbH or your local Tremipen® distributor. 15. Reference to Clinical Performance A Clinical Evaluation for the Clinical Performance is available for the Tremipen®. -
Page 38: Ce-Label
18. Warranty and Contact For information about warranty conditions and ser- vices, please contact the local distributor for Tremipen products. Hotline + 43 660 55 10 380 Website www.tremitas.com 19. Local Tremitas Partner For warranty claims, please contact the following organization:... - Page 39 Notes...
- Page 40 Notes...
- Page 42 Tremitas GmbH Schleppe-Platz 5 A - 9020 Klagenfurt www.tremitas.com TPHL004E...
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