medi protect.SIS, Instructions For Use Manual, Page: 5 / 38

protect.SIS
Intended purpose
protect.SIS is a shoulder joint support for immobilising the shoulder in a
defined position.
Indication
For all indications which require immobilisation of the shoulder joint with
internal rotation support, such as:
• For conservative treatment for anterior dislocated shoulder / chronic
anterior subluxation
• Following rotator cuff repair
• Separated shoulder (conservative, post-operative)
•
Scapular fracture (conservative, post-operative)
• Proximal humeral head fracture (conservative, post-operative)
Contraindications
• All indications that require abduction and/or external rotation
•
Conservative and post-operative therapy of posterior shoulder
dislocation
Risks / Side Effects
If the aids are too tight, this can cause local pressure sores or constriction
of blood vessels or nerves. Therefore you should consult the doctor
treating you before you use it if the following circumstances apply to you:
• Condition or injury of the skin in the area of application, particularly
with infectious indications (excessive heat, swelling or reddening)
• Paraesthesia and circulatory disorders (e.g. as seen in diabetes, varicose
veins)
•
Lymph drainage disorders – equally, swelling of soft tissue adjacent to
the area of application which is not related to a condition
When wearing snug-fitting aids, this can result in localised skin
inflammation or irritation that is due to mechanical irritation of the skin
(particularly in conjunction with sweating) or due to the composition of
the material.
Intended patient groups
Healthcare professionals should provide care to the adults and children,
applying the available information on the measurements/sizes and
necessary functions/indications and in line with the information provided
by the manufacturer, and acting under their own responsibility.
Fitting instructions
• Please wash before first use.
• Wrap the longer strap around your body and fasten it just below the
breast. The strap sewn to the brace must be on the injured side, and the
thin strap with the loop for your hand must be at the back.
• Fix the injured arm with the strap around your upper arm.
• Pass the thin strap up over the healthy shoulder. Slide the hand of your
injured arm through the loop.
• After adjusting the length of the strap with the hand loop fix the hand
loop to the breast belt with the hook and loop strip.
Care instructions
Hook and loop fasteners should be closed for washing. Soap residues,
lotions and
ointments can cause skin irritation and material wear.
• Wash the product by hand, preferably using a medi clean detergent, or
in delicate cycle at 30°C using a mild detergent without fabric
conditioners.
• Do not bleach.
• Leave to dry naturally.
• Do not iron.
• Do not dry clean.
    
Storage instructions
Please keep the brace in a dry place and do not expose it to direct sunlight.
Material composition
Polyamide, PU, polyester, cotton
Liability
The manufacturer’s liability will become void if the product is not used as
intended. Please also refer to the corresponding safety information and
instructions in this manual.
Disposal
The product can be disposed of in the domestic waste.
In the event of any complaints regarding the product such as damage to
the fabric or a fault in the fit, please report to your specialist medical
retailer directly. Only serious incidents which could lead to a significant
deterioration in health or to death are to be reported to the manufacturer
or the relevant authorities in the EU member state. The criteria for serious
incidents are defined in Section 2, No. 65 of the Regulation (EU) 2017/745
(MDR). The traceability of this product is assured via a UDI code
.
English
E009617_AAL_protect_SIS.indd 5 06.11.20 11:41