Product Description - Bauerfeind GloboPed Manual De Instrucciones

Dear Customer,
GB
Please read through the instructions for use carefully and direct any questions to your
physician, medical retailer, or our technical service department at the telephone number
+44 (0) 121 446 53 53 (UK)/+1 800 423 34 05 (USA).
Certifi cation Information
Bauerfeind AG is certifi ed in accordance with DIN EN ISO 13485:2003 as well as DIN EN
ISO 9001.
Classifi cation
The "Postop" forefoot-relieving orthosis is a medical product as defi ned by the German
Medical Product Law, classifi ed in Class I (in accordance with Directive 93/92/EEC, Annex
IX/III, 1.1).
Service Number
You can reach our Customer Service Department at the telephone number +44 (0) 121 446 53 53
(UK)/+1 800 423 34 05 (USA).
Purpose
The "Postop" forefoot-relieving orthosis is a high-quality orthopedic device for targe-
ted relief for the area around the forefoot and front metatarsal area.
Indications/Use
•
For early post-operation and/or post-traumatic recovery of the forefoot and front
metatarsal area
•
Treatment for diabetic foot ulcers in the forefoot area
•
For rheumatic feet and algodystrophic syndromes
Risks/Side Effects/Contraindications
Mobility and balance may be compromised based on the purpose and desired function of
the forefoot-relieving orthosis.
There are no known side effects on the entire body. The strap shoe should only be worn
after consulting trained technical personnel.
There are no known hypersensitivities that cause illnesses. This device should only be
worn after consulting your physician in the following clinical situations:
•
Skin diseases/injuries in the body part being treated, particularly if infl ammation
appears. The same applies for accumulated scars with infl ammation, redness, or
overheating
•
Acroparesthesia in the body part being treated
•
Lymphoid circulation problems, unclear soft tissue infl ammation around the device's
area of application
Guaranty
A guaranty is provided as stipulated by legal regulations. First-time application and fi tting
of the forefoot-relieving orthosis may be carried out by trained technical personnel only,
otherwise no product liability will be assumed.

Product Description

The "Postop" forefoot-relieving orthosis is a prescribable product that may only be
worn under a physician's direction and only in accordance with these instructions of use
and for the applications named.
The "Postop" forefoot-relieving orthosis may only be worn with a correctly installed
4
protective frame that secures the forefoot against mechanical infl uence.
Use
This product is intended for the treatment of one individual patient and may not be re-
used or used by others. No product liability will be assumed in the event of inappropriate
use.
The forefoot-relieving orthosis should be put on while sitting and can be worn both
on the left and right foot. Put on with the Velcro snuggly on the foot, although not too
tight in order to avoid pressure points on the skin respectively damages of arteries, and
nerves.
Always wear a non-skid shoe with the same sole height on your healthy foot. If necessary,
a physician may prescribe that the height of the sole / heel be changed by an orthopedic
technician or orthopedic shoe technician.
Safety Notice
Any open wounds on the foot must be protected by a bandage or similar device. Do not do
not ride a bicycle or drive a car or any other vehicle while wearing the orthosis.
Use crutches when wearing a forefoot-relieving orthosis.
Wearing the "Postop" forefoot-relieving orthosis is only recommended in hospitals and
clinics or within your own home and not in public areas.
Please see your physician immediately should you notice any irregular changes in your
body (i.e. increase in pain).
Do not alter the product in any way as it may affect the product's functionality such that
no product liability will be assumed.
Technical Information
Model Size Shoe Size Article Number
Postop S 33-34 3 662700 001
M 35-38 3 662700 002
L 39-42 3 662700 003
XL 43-46 3 662700 004
Accessories
Model
Protective Frame, Black Plastic
Protective Frame, Aluminum
Maintenance and Care
handwash do not
bleach
Be sure to have your "Postop" forefoot-relieving orthosis checked regularly for
functionality and closing functionality by an orthopedic technician or orthopedic shoe
technician and exchanged if needed.
We recommend washing the orthosis separately at 40° C and by hand using a delicate
detergent. We recommend closing the Velcro before washing in order to preserve its
functionality and avoid damage. The orthosis should not be exposed to direct heat when
drying (i.e. heating vents, sun light, etc.).
We have tested this product within the scope of our integrated quality management
system. Should you nevertheless have a complaint, please contact our local technical
consultant or our customer service department.
Size Article Number
S+M 3 662490 002
L+XL 3 662490 003
S-XL 3 662490 001
do not do not do not
tumble dry iron dry-clean
Version: March 2008
5