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Summary of Contents for Healy TimeWaver
- Page 1 Healy Electrostimulation device Instructions for Use Frequencies for your life...
- Page 2 Healy Instructions for Use TimeWaver Production GmbH Darritzer Str. 6 16818 Kränzlin Germany TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany...
- Page 3 Healy Electrostimulation device Instructions for Use T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de...
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Page 4: Table Of Contents
6 Cleaning, disinfection and maintenance 6.1 General 6.2 Cleaning 6.3 Disinfection 6.4 Storage between applications 6.5 Proper use of the electrodes 6.6 Maintenance 6.7 Troubleshooting 7 Scope of Delivery TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... - Page 5 13.2 Care and storage of the electrodes 13.3 Service life of the product 13.4 Specifi cations 13.5 Transport and storage 13.6 Important note on using the ear electrodes T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de...
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Page 6: General
1 General 1.1 Preamble Thank you for choosing a TimeWaver device. Please read this manual carefully and pay special attention to the security advices. This document is part of the medical device Healy of the company TimeWaver Production GmbH. The copyrights belong to the company. -
Page 7: Healy
fi elds. The basis for the approval of the Healy as a medical device class IIa are some programs for microcurrent stimulation, which are included in the standard software package. -
Page 8: Description
2.4.1 Hardware Description The Healy is a portable device with an internal battery. On the top you can fi nd an On-Off switch and icons. The connection to the power supply is in the front, marked as pos. 8. The stimulation output is in 90° (see pos. 9) op- posite to the power supply socket, this way it is not possible to charge and stimulate at a time. -
Page 9: General
2.5 General The Healy is a medical device for use only under justifi ed medical conditions and only by users which are familiar with the use of the device. Use only as directed. Intentional misuse by wrong settings or under wrong conditions can be harmful, fatal or reduce the medical benefi... -
Page 10: Product Compliance
You should keep a safety distance of 30 cm (12 inch) to HF-communication devices of parts and cables of the Healy, when the device is in use. Please don’t staple it with such devices or put it next to other electrical equip- ment when used. -
Page 11: Preparations For Using The Healy
Note: By unplugging the USB-connection from the Healy Hardware, you are disconnected from the mains supply. The internal power supply cannot be unplugged. 4.1.5 Pairing via Bluetooth After installation of the App switch on the Healy by shortly pushing the on-switch (see fi gure 4.1.5.1) of the device Figure 4.1.5.1: ON- OFF-switch After starting the App there is a short starting screen (see fi... - Page 12 Within up to about 20 seconds the App scans the en- Figure 4.1.5.5: Connect screen vironment and connects to the Healy automatically. If your smartphone detects a Healy fi gure 4.1.5.4 ap- pears. TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany...
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Page 13: Connection Of The Electrodes
Instructions for Use 4.1.6 Connection of the electrodes Put the plugs of the electrode cables into the sockets of the Healy. Take care for the polarity. Place the electrodes onto the desired treatment area. Important note on using the adhesive electrodes: •... -
Page 14: Operating The Healy
5.1 Starting the treatment using the smartphone After the installation of the app, pairing and connection of the electrodes, the Healy is ready for operation. In the overview interface you can select which program page you want to select (see fi gure 5.1.1). - Page 15 (see fi gure 5.1.4). In the treatment page you can set the intensity of you program by using the plus and mi- nus buttons. T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de...
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Page 16: Handling Of The Healy Hardware
5.2 Handling of the Healy hardware During the treatment you should use the clip on the back of the device to attach the Healy to your clothes. The electrodes should be affi xed like recommended in the pictographs of the App (please refer to chapter 10). Route the electrode cables to the Healy in such a way that you feel comfortable and they don’t constitute an obstacle. -
Page 17: Cleaning, Disinfection And Maintenance
6.2 Cleaning Switch off the Healy before cleaning. For cleaning, commercial cleaning products may be used. The surfaces can be wiped with a damp sponge or cloth. Do not use too much liquid and make sure that no liquid penetrates be- neath the covers or enclosures. -
Page 18: Maintenance
Contact your authorized dealer or the manufacturer bance TimeWaver Production GmbH App Store is trademark of Apple Inc. Play Store is a trademark of Google Inc. TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... -
Page 19: Scope Of Delivery
7 Scope of Delivery The Healy is delivered with a power supply adapter, a set of electrodes and a charging cable. Reference number Description Quantity 0006 Healy hardware device 108-4063 Press button adhesive electrodes round Ø 32 mm 108-4062 Connection cable for electrodes 96 cm - press button on 2 mm... -
Page 20: Technical Data
Protection class Class II Compliance IEC60950 8.2.2 Power source requirements The Healy can be connected to any power source with the supplied USB-charging cable and the following spec- ifi cations: Supply voltage range 4.4 V – 5.5 V DC Output current Max. -
Page 21: Electromagnetic Compatibility
EN55022 30MHz – 1GHz and 1GHz – 6 GHz, class B The Healy is suitable for use in all establishments, including the domestic area and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. -
Page 22: Mechanical Parameters
5 ms 5 ms 5 ms 5 ms Depression +/- 600 µA 0.5 Hz Anxiety +/- 600 µA 0.5 Hz Learning +/- 200 µA 0.5 Hz TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... -
Page 23: Disposal
Waste electrical products should not be disposed of with household waste. Please recycle at the according facili- ties. Ask your local authority or dealer for recycling advice. T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de... -
Page 24: Used Symbols And Icons
Symbol for Battery Minus icon for negative electrode socket Symbol for on- and off-switch Plus icon for positive electrode socket Symbol for USB-Connection One patient use TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... - Page 25 Pictograph for the placement of bracelet electrodes. Appears after selection of the stimulation program Note: the background colour may vary, depending on the selected and confi gured program parameter T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de...
- Page 26 Button for moving one page back Button for moving one page for- wards Note: The background colour may vary, depending on the selected and confi gured program parameter TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany...
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Page 27: Attachment Instruction For Use "Electrodes" Ref: 108-4063 - Press Button Adhesive Electrodes Round Ø 32 Mm
Production GmbH is not responsible for the content. The electrodes have been tested and evaluated together with the Healy and are safe and effective for use, if the recommendations and advices are followed prior to use. 11.1 Description and specifi cations These cutaneous electrodes are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient‘s skin. -
Page 28: Warning
We recommend to report opportunely any malfunction or defect of the product to FIAB Quality Assurance Service. TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... -
Page 29: Disposal
(chlorine oxides, sodium hypochlorite, etc.) before being disposed of. FIAB S.p.A. Via Costoli, 4 – 50039 – Vicchio (Florence, Italy) – www.fi ab.it T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de... -
Page 30: Attachment Instruction For Use "Electrodes" Ref: 108-4061 Bracelet Electrode (Black, Carbon)
Production GmbH is not responsible for the content. The electrodes have been tested and evaluated together with the Healy and are safe and effective for use, if the recommendations and advices are followed prior to use. 12.1 Description and indications The reusable conductive electrical stimulation bracelets are made of conductive fabric and hydratable material or conductive elastic fabric. -
Page 31: Guarantee - Notice
(chlorine oxides, sodium hypochlorite, etc.) before being disposed of. FIAB S.p.A. Via Costoli, 4 – 50039 – Vicchio (Florence, Italy) – www.fi ab.it T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de... -
Page 32: Attachment Instruction For Use "Electrodes" Ref: 108-4004 Ear Electrodes (Pair)
Upon recognition of any damages, the product shall not be used anymore and shall be disposed. 13.4 Specifi cations Connectors: 2 mm connector 13.5 Transport and storage Ambient temperature: -20°C to 70°C, Humidity 15% - 93% TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany... -
Page 33: Important Note On Using The Ear Electrodes
• For hygienic reasons, the electrodes may only be used for one individual patient. This means that every patient re- quires his/her own pair of ear electrodes. TimeWaver Production GmbH Darritzer Str. 6 16818 Kränzlin, Germany T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de... - Page 34 Healy Instructions for Use TimeWaver Production GmbH | Schloss Kränzlin | Darritzer Str. 6 | 16818 Kränzlin - Germany...
- Page 35 T. +49 3391 40022-11 | F. +49 3391 40022-99 | www.healy.de | info@healy.de...
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