IMM1039 Immedia Positioning Wedge
Product Information:
The Etac Positioning Wedge is a Class 1 medical device compliant
with the Medical Device Regulation (EU) 2017/745. It is designed to
support and position users in baths, for lower body hygiene,
bed-baths, resting, raising head or foot end, etc. The product is
intended for use in Acute care, Long-term care, and Home care
environments and has a user mass limit equal to the maximum rated
load. The product has an expected service life of 1 to 2 years
under normal use and comes with a two-year warranty on material and
manufacturing defects.
Product Usage Instructions:
Before using the Etac Positioning Wedge, please read the
Instruction for Use carefully to avoid accidents and injury when
moving and handling the product. The person described as the user
in this manual is the person who is lying or sitting on the
product, while the carers are the people who manoeuvre the
product.
To position the user, one or more Positioning Wedges can be
positioned to best suit the individual user and to help maintain
the user’s position. The user will feel more comfortable and
relaxed in the position. As the carer does not have to stand and
support the user, bathing, lower body hygiene, bed-baths, etc. will
be far less of a strain on the carer.
If adjustments, repairs or combinations not predetermined by
Etac are made to the product, the Etac CE certification and Etac
warranty will not be valid. If in doubt, please contact Etac. The
product can be scrapped according to national regulations.
In case of an adverse event occurred in relation to the device,
incidents should be reported to your local dealer and the national
competent authority in a timely manner. The local dealer will
forward information to the manufacturer.
For further information on the Etac Patient handling, please
visit www.etac.com.
Instruction for use
IMM1039_IFU.Version8.2020-09-11
Positioning Wedge
Index
Illustrations…………………………………..3 User manual English ………………….4 Bruksanvisning Svenska…………….9 Bruksanvisning Norsk …………….. 14 Brugervejledning Dansk………….. 19 Käyttöohjeet Suomi…………………24 Gebrauchsanweisung Deutsch … 29 Gebruiksaanwijzing Nederlands … 34 Instruction d’utilisation Francais … 39 Istruzioni per l’uso Italiano ……… 44 Instrucciones de uso Español …. 49
See www.etac.com
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Illustrations
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FR
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General
Thank you for choosing an Etac product.
To avoid accidents and injury when moving and handling the products, please read this manual carefully.
The person described as “the user” in this “Instruction for Use” is the person who is lying or sitting on the product. The carers are the people who manoeuvre the product.
This symbol appears alongside the text in the manual. It draws the reader’s attention to points at which there may be a risk to the health and safety of the user or carer.
These products comply with the standards applicable for Class 1 products in the Medical Device Regulation (EU) 2017/745 on medical devices.
At Etac we strive to continually improve our products and therefore we reserve the right to make changes to products without prior warning. All measurements given on illustrations and similar material are for guidance only and Etac cannot be held liable for errors and defects.
The information given in this manual, including recommendations, combinations and sizing, does not apply to special orders and modifications. If the customer makes adjustments, repairs or uses combinations not predetermined by Etac, the Etac CE certification and Etac warranty will not be valid. If in doubt, please contact Etac.
Warranty: Two-year warranty on material and manufacturing defects, provided that the product is used correctly.
Expected lifetime: The device has an expected service life of 1 to 2 years under normal use. The service life of the device varies depending on usage frequency, loads and how often and how it is washed.
For further information on the Etac Patient handling, see www.etac.com.
In case of an adverse event occurred in relation to the device, incidents should be reported to your local dealer and the national competent authority in a timely manner. The local dealer will forward information to manufacturer.
Symbols in general Washing Do not bleach
Disinfect / Wipe off Never leave on the floor
Warning
Production year, month and day
Manufacturer CE -certification
Tumbledry
Risk of sliding down
Iron
Keep out of the sun
Do not dryclean
Read the user manual
Medical device
Intended use
Positioning Wedges can be used to support and position users in baths, for lower body hygiene, bed-baths, resting, raising head or foot end, etc.
Batch no./Lot no.
User mass limit = maximum rated load
The product can be scrapped according to national regulations
Keep dry Non sterile Article number
Intended environment Acute care, Long-term care, Home care
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GB ILL.
Practical handling
Positioning One or more Positioning Wedges can be positioned to best suit the individual user and to help maintain the user’s position.
Use
The user feels more comfortable and relaxed in the position. Carers can position the user using a Positioning Wedge or Wedges. As the carer does not have to stand and support
the user, bathing, lower body hygiene, bed-baths, etc. are far less a strain on the carer.
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Notice
Special features
Always check the product before use and after washing.
Never use a defective product. If the product shows signs of wear-and-tear, it must be scrapped.
Read these instructions carefully.
It is important that carers receive instruction in manual handling. Etac offers advice and training for carers. For further information, contact Etac.
Always use the correct manual handling techniques.
Encourage the user to assist where possible.
To ensure that the user feels safe and that every manual handling is smooth, always plan the manual handling in advance.
There is a risk that the user may slide off. Never leave the user alone on the edge of the bed. Never leave the product on the floor.
Always conduct a risk assessment, and ensure that the assistive product can be used for the individual user and, in combination with other devices, that it is safe for the user and carers.
If in any doubt – please contact Etac.
Material and cleaning
Material: Positioning Wedge: Polyurethane foam. Cover: Polyester, polyurethane.
The product should be checked regularly, preferably each time it is used, and especially after washing.
Check that there is no damage to seams or fabric.
Never try to repair a product yourself. Never use a defective product.
Washing instructions: Remove foam before washing. Do not use fabric softener. This product can be cleaned with a solvent-free cleaning agent with a pH level between 5 and 9, or a 70% disinfection solution.
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Products and accessories
Article no. IM53NS IM53/80NS IM5300NS IM5300/80NS
Product Description Positioning Wedge S Positioning Wedge L Positioning Wedge Cover Positioning Wedge Cover
Size (mm) W300xL530xH200 W300xL800xH200 W300xL530xH200 W300xL800xH200
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Service information
Inspection
First inspection: · Is the packaging intact? · Read the label on the packaging and check the article no. and product description · Check that Short Instruction is enclosed updated User Manual/Instruction for use can be downloaded from www.etac.com or contact your Etac
Customer Service or the local dealer. · Check the label on the product – does it include article no., product description, lot/batch no., cleaning instructions and supplier name?
Periodic Inspection: · Make sure that your Manual transfer system always is in a perfect condition. · After wash always check materials, stitching, handles, buckles. · If the product shows signs of wear and tear, it must be removed from service immediately.
Visual inspection/Check the product: Ensure that the materials, seams, stitching, handles, buckles are intact/faultless.
Mechanical load or stress/Test handles: Draw hard in the handles in opposite directions and control the material, seams and stitching. Test buckles: Lock the buckle and draw in opposite directions, control the buckle and the stitching.
Check: Manual transfer aids with handles, straps and buckles:
Stability test: Try to bend the product verify that it feels firm, stable and solid.
Test low/high friction: Place the product on a firm surface or a bed, place your hands on the material and test the friction by pushing your hands down into the product. Low friction slides effortlessly High friction no sliding/moving
Manual transfer aids with for sitting and lying transfer and with high or low friction:
Production year, month and day
The product can be scrapped in accordance with national regulations
Read the user manual
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Etac - A world-leading developer of assistive devices
