Sunrise Medical Switch-It MicroPilot, Руководство пользователя

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Switch-It
®
MicroPilot
™
Owner’s Manual
247751 Rev. C 6
Warranty
Each Switch-It device is carefully inspected and tested to provide peak performance. Every Switch-It device is covered under a limited,
express warranty.
1. All
electronic components
are covered under warranty for twelve (12) months from the date of shipment, provided normal use,
unless modifi ed or damaged.
2. All
mounting hardware
is covered under warranty for twelve (12) months from the date of shipment, provided normal use, unless
modifi ed or damaged.
3. All
wearable items
(covers, pads, etc.) are covered under warranty for three (3) months from the date of shipment, provided
normal use, unless modifi ed or damaged.
Warranty claims should be processed through the nearest Sunrise Medical authorized dealer. A Return Authorization number must be
obtained prior to returning the item for evaluation, along with details of the issue.
Items returned for warranty claim must be evaluated by Switch-It before warranty determination is made. Should a defect in materials or
workmanship occur during the warranty period, and the item has not been modifi ed or damaged, Switch-It will, at its option, rework or
replace it without charge.
Except for express warranties made herein, all other warranties, including implied warranties of merchantability and warranties of fi tness
for a particular purpose, are excluded. There is no implied warranty beyond what is contained herein. Remedies for breach of express
warranties herein are limited to rework or replacement of the goods. In no event shall damages for breach of any warranty include any
consequential damages or exceed the cost of non-conforming goods sold.
NOTE: General user advice. Not following these instructions may result in physical injury, damage to the product or damage to the environment!
A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority
of the Member State in which the user and/or patient is established.
As the manufacturer, SUNRISE MEDICAL, declares that this product conforms to the Medical Device Regulation (2017/745).
B4Me special adaptations
Sunrise Medical strongly recommends that in order to ensure that your B4Me product operates, and performs as intended by the manufacturer; all the user information
supplied with your B4Me product is read and understood, before the product is first used. Sunrise Medical also recommends that the user information is not discarded after
reading it, but it is kept safely stored for future reference.
Medical Device Combinations
It may be possible to combine this Medical device with one or more other Medical Device or other product. Information on which combinations are possible can be found
at www.SunriseMedical.com. All combinations listed have been validated to meet the General Safety and Performance Requirements, section 14.1 of the Medical Device
Regulation 2017/745.
Guidance on the combination, such as mounting, can be found at www.SunriseMedical.com.
We at SUNRISE MEDICAL have been awarded the ISO-13485 certifi cate, which affi rms the quality of our products at every stage, from R & D to production. This product
meets the requirements in accordance with EU regulations. Options or accessories shown are available at extra cost.
The varieties of fi tting variants, as well as the modular design, mean that it can be used by those who cannot walk or have limited mobility because of:
- Paralysis
- Loss of extremity (leg amputation)
- Extremity defect deformity - Joint contractures/joint injuries
- Illnesses such as heart and circulation defi ciencies, disturbance of equilibrium or cachexia as well as for elderly people who still have strength in the upper body.
The wheelchair shall not be used in case of:
- Perception disorder
- Imbalance - Seating disability
CE Mark
Date of
Manufacture
Serial Number
This symbol
means Medical
Device
Manufacturer
European
Authorised
Representative
XXXX-XX-XX
Sunrise Medical (US) LLC
2842 Business Park Ave,
Fresno, CA 93727
YYYY-MM-DD
MP-#####
SN
MD
Sunrise Medical GmbH
Kahlbachring 2-4
69254 Malsch-HD / Germany
Type: MicroPilot
Alternate
Control
EC REP