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Rehadapt Rehadapter Instructions For Use Manual

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TM
Instructions for use
EN
EN ISO 13485

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Summary of Contents for Rehadapt Rehadapter

  • Page 1 Instructions for use EN ISO 13485...
  • Page 2 Sie den Link, um die Gebrauchs- load the user manual in your anweisung in Ihrer Sprache zu erhalten. own language. https://rehadapter.com/manual_de https://rehadapter.com/manual_en Escanee el Código-QR con su Scannez le code QR avec votre móvil o utilice el enlace para téléphone ou utilisez le lien...
  • Page 3 All contents in these instructions for use, especially the text, photographs, and graphics, are protected by copyright. Unless expressly stated otherwise, the copyright lies with Rehadapt Engineering GmbH & Co. KG. Any duplication requires the prior written consent of Rehadapt Engineering GmbH & Co. KG.
  • Page 4 4 4 U U s s i i n n g g t t h h e e R R e e h h a a d d a a p p t t e e r r ™ ™ – – U U s s e e r r ............................................. . 1 1 5 5 Turning the Rehadapter™ on/off ...................... 15 Pairing the Rehadapter™ with the tablet ..................15 Unpairing the Rehadapter™ from the Tablet ................... 16 Volume Control ..........................
  • Page 5 Temperature and Humidity ......................24 6.1.1 General Use ............................24 6.1.2 Charging the Rehadapter ........................24 6.1.3 Transport and Storage ........................24 Maintenance and Care ........................24 Cleaning ............................24 6.3.1 General Disclaimer ........................... 24 6.3.2 Cleaning the Rehadapter™ ....................... 25 Redispatch and Return ........................
  • Page 6 The Rehadapter™ is a certified class I medical device that serves as a communication aid in combination with the following iPads: M M o o d d e e l l V V e e r r s s i i o o n n A A r r t t .
  • Page 7 S S y y m m b b o o l l s s a a n n d d M M a a r r k k i i n n g g s s The following symbols can be found on Rehadapt products, accessories, instructions for use or on the packaging: ...
  • Page 8 The Rehadapter™ is not life-sustaining nor life-supporting but is intended to accompany the patient during their daily activities. To do so, it can be mounted on any Rehadapt mount featuring a Universal Device Socket (UDS), used handheld or stand-alone either simply lying on a surface or with its integrated stand.
  • Page 9 G G e e n n e e r r a a l l H H a a n n d d l l i i n n g g Do not use the Rehadapter™ as a life-sustaining or life-supporting device. In the event of a functional ...
  • Page 10 Only use the charger under supervision of a parent, a legal guardian, or a caregiver.  Do not expose the Rehadapter™ to fire or to temperatures above 40 °C (104 °F) as both can lead to  battery malfunction and heat dissipation. Situations such as a car trunk on a hot day or a comparable environment might exceed the advised range of temperature.
  • Page 11  becoming very hot. Do not expose the Rehadapter™ to fire or to temperatures above 40 °C (104 °F) as both can lead to  battery malfunction and heat dissipation. Situations such as a car trunk on a hot day or a comparable environment might exceed the advised range of temperature.
  • Page 12 During use, the Rehadapter™ may only be touched in the designated areas. Keep 1cm [0.40”] between  the casing and the user in the area surrounding the kickstand. It is required to keep 30cm [12”] between the Rehadapter™ and any mobile transmitter for standard- ...
  • Page 13 R R e e h h a a d d a a p p t t e e r r ™ ™ O O v v e e r r v v i i e e w w Figure 3.1 Rehadapter™ overview P P o o s s .
  • Page 14 Blinking purple (slow with long pause) Charging (Connecting) Blinking purple (slow) Charging (Connected) Solid purple Charger Error 4x blinking red, pause, repeating Amplifier Error 3x blinking red, pause, repeating Reset Indicating device versions (Contact Rehadapt Engineering for more information) 1 1 4 4...
  • Page 15 This section includes the instructions for use for the end-user. It includes all the information the end-user needs to know to use the Rehadapter™ according to its intended purpose (as defined in Section 1.2). For C C h h a a p p t t e e r r 5 5 information about the initial setup of the Rehadapter™, refer to...
  • Page 16 U U n n p p a a i i r r i i n n g g t t h h e e R R e e h h a a d d a a p p t t e e r r ™ ™ f f r r o o m m t t h h e e T T a a b b l l e e t t To unpair the Rehadapter™ from the tablet, go to Bluetooth® settings on the tablet and remove the Rehadapter™...
  • Page 17 S S w w i i t t c c h h C C o o n n n n e e c c t t o o r r s s  You can connect up to two switches to the Rehadapter™, which are attached to the 3.5 mm ports ...
  • Page 18 4 4 . . 8 8 . . 1 1 L L y y i i n n g g D D o o w w n n The Rehadapter™ can be lie down on a flat surface. In this case, the screen has an angle of use of 10°, F F i i g g .
  • Page 19 4 4 . . 8 8 . . 4 4 M M o o r r e e P P o o s s s s i i b b i i l l i i t t i i e e s s In addition, the Rehadapter™ can be used handheld, carried by its handle, or with a shoulder strap.
  • Page 20 S S e e t t t t i i n n g g u u p p t t h h e e R R e e h h a a d d a a p p t t e e r r ™ ™ – – A A u u t t h h o o r r i i z z e e d d D D i i s s t t r r i i b b u u t t o o r r Only authorized distributors may set up and adjust the Rehadapter™. Attempting to set up and adjust ...
  • Page 21 5 5 . . 1 1 . . 3 3 C C l l o o s s i i n n g g t t h h e e R R e e h h a a d d a a p p t t e e r r ™ ™  Reattach the Rehadapter™ back casing. Make sure every part is correctly aligned. Tighten the bolts (12x) on the back casing.
  • Page 22 5.a. The white and grey keyguard blocks are self-adhesive on one side. When using the white or grey blocks, attach the keyguards from the front of the Rehadapter after it has been closed (as shown in Section 4.6). For a correct positioning, the self-adhesive side of the white and grey keyguard blocks must face the ...
  • Page 23 ( ( 5 5 . . 1 1 . . 3 3 C C l l o o s s i i n n g g t t h h e e R R e e h h a a d d a a p p t t e e r r ™ ™ ) ) Insert the tablet and close the Rehadapter™...
  • Page 24 6 6 . . 1 1 . . 1 1 G G e e n n e e r r a a l l U U s s e e Use the Rehadapter™ in a dry environment and at room temperature. It is advised to stay within the following temperature and humidity range: •...
  • Page 25 We recommend keeping the original packaging of the Rehadapter™. If the device is returned to  Rehadapt Engineering GmbH & Co. KG for a warranty claim or a repair, use the original packaging for shipping. 6 6 . . 5 5 D D i i s s p p o o s s a a l l o o f f t t h h e e R R e e h h a a d d a a p p t t e e r r ™...
  • Page 26 Tablet On/Off button does not work  is clogged with dirt Open the Rehadapter and clean The button ( ( F F i i g g . . 5 5 . . 2 2 ) ) the button area ...
  • Page 27 W W a a r r r r a a n n t t y y Rehadapt Engineering GmbH & Co. KG warrants that for a period of 3 years from the date of purchase, the Rehadapter will substantially conform with its specifications, be free from defects in material and workmanship, and will perform in accordance to its basic intended purpose.
  • Page 28 Engineering GmbH & Co. KG does not guarantee that the Rehadapter™ will meet all user requirements, that the operation of the Rehadapter™ will be uninterrupted under all circumstances, or that the Rehadapter™ will always be free of errors and defects.
  • Page 29 (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications to this product not authorized by Rehadapt Engineering GmbH & Co. KG  could void the user’s authority to operate the product.
  • Page 30 R R e e g g u u l l a a t t i i o o n n s s , , D D i i r r e e c c t t i i v v e e s s a a n n d d S S t t a a n n d d a a r r d d s s The Rehadapter™ is a class I medical device and complies with the following regulations and directives: •...
  • Page 31 M M o o u u n n t t i i n n g g S S y y s s t t e e m m s s Rehadapt UDS S S u u p p p p o o r r t t e e d d...
  • Page 32 B B 2 2 . . 2 2 M M e e d d i i c c a a l l P P o o w w e e r r A A d d a a p p t t e e r r I I N N T T S S p p e e c c i i f f i i c c a a t t i i o o n n M M o o d d e e l l EM1012AVRU...
  • Page 33 A A p p p p e e n n d d i i x x C C F F u u n n c c t t i i o o n n s s o o f f t t h h e e B B u u t t t t o o n n s s F F u u n n c c t t i i o o n n I I n n p p u u t t T T u u r r n n o o n n...
  • Page 34 Rehadapter GA HeadMouse Nano • Keyguards for the Rehadapter™/Rehadapter™ Pro are available upon request. This list is continuously updated. Find the latest information on accessories at www.rehadapt.com. Read the respective instructions for use for using each accessory. Only authorized distributors may mount accessories.
  • Page 35 W W A A R R N N I I N N G G : : Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Rehadapter™, including cables specified by the manufacturer.

  • Page 36: Harmonic Distortion

    E E M M I I C C o o m m p p l l i i a a n n c c e e T T a a b b l l e e – – E E m m i i s s s s i i o o n n P P h h e e n n o o m m e e n n o o n n C C o o m m p p l l i i a a n n c c e e E E l l e e c c t t r r o o m m a a g g n n e e t t i i c c e e n n v v i i r r o o n n m m e e n n t t...

  • Page 37: Voltage Interruptions

    5240 5100-5800 Pulse modulation 217 Hz, 9 V/m 5500 5785 E E M M S S C C o o m m p p l l i i a a n n c c e e T T a a b b l l e e — — I I n n p p u u t t A A C C p p o o w w e e r r P P o o r r t t P P h h e e n n o o m m e e n n o o n n B B a a s s i i c c E E M M C C I I m m m m u u n n i i t t y y t t e e s s t t l l e e v v e e l l s s...
  • Page 38 3 3 8 8...
  • Page 39 Your new AAC hub equipped with all features needed Support for all Ultimate access methods protective case Loud and clear sound amplifier Multiple options for Maximum positioning portability...