Meldepflicht; English - Bauerfeind SacroLoc Bedienungsanleitung

Meldepflicht

Aufgrund regionaler gesetzlicher Vorschriften sind Sie verpflichtet,
jeden schwerwiegenden Vorfall bei Anwendung dieses Medizinproduktes
sowohl dem Hersteller als auch dem BfArM (Bundesinstitut für
Arzneimittel und Medizinprodukte) unverzüglich zu melden. Unsere
Kontaktdaten finden Sie auf der Rückseite dieser Broschüre.
Entsorgung
Sie können das Produkt entsprechend den nationalen gesetzlichen
Vorschriften entsorgen.
2
Fachpersonal
Allgemeine Hinweise
Überprüfen Sie nach der ersten Versorgung den optimalen und
individuellen Sitz der SacroLoc. Die Rückenpelotten müssen in ihrer
Position auf das Becken angepasst werden, sodass diese auf den
hinteren oberen Darmbeinstacheln mit der inneren Aussparung
aufliegen.
Üben Sie das richtige Anlegen mit dem Patienten.
Eine unsachgemäße Änderung am Produkt darf nicht vorgenommen
werden. Bei Nichtbeachtung kann die Leistung des Produktes beein­
trächtigt werden, so dass eine Produkthaftung ausgeschlossen wird.
Materialzusammensetzung
Polyamid (PA), Thermoplastisches Elastomer (SEBS),
Polyurethan (PUR), Elastan (EL), Polypropylen (PP),
Polyester (PES), Polyoxymethylen (POM), Baumwolle (CO), Polyethylen
(PE), Acrylat­Kleber (A)
– Medical Device
– Kennzeichner der DataMatrix als UDI
barrierefreie Version
www.bauerfeind.de/barrierefrei
Stand der Information: 2024­02
* Hinweis auf Gefahr von Personenschäden (Verletzungs­, Gesundheits­
und Unfallrisiko) ggf. Sachschaden (Schäden am Produkt).
1 Orthese = orthopädisches Hilfsmittel zur Stabilisierung, Entlastung,
Ruhig stellung, Führung oder Korrektur von Gliedmaßen oder Rumpf
2 Fachpersonal ist jede Person, die nach den für Sie geltenden
staatlichen Rege lun gen zur Anpassung und Einweisung in den
Gebrauch von Orthesen befugt ist.
en

english

Dear Customer,
thank you for choosing a Bauerfeind product.
We work to improve the medical effectiveness of our products every
day – because your health is very important to us. Please read and
observe these instructions for use carefully. If you have any questions,
please contact your doctor or medical retailer.
Intended purpose
SacroLoc is a medical device. It is an orthosis
pelvis and targeted relief of the sacroiliac joints.
Indications
• Sacroiliac joint disorders (SI joint syndrome, osteoarthritis of the
SI joint, SI joint instability)
• Pelvic girdle instability, e. g. symphysis rupture and loosening
• Sacroiliac joint blockage (acute and prophylactic)
• Myalgia and tendinopathy in the pelvic region
• Structural disturbances following spinal fusion (in the transition from
L5 to S1)
• Non­surgical treatment following pelvic fractures
Risks of using this product
Caution*
Please closely observe the specifications in these instructions for use
and the instructions given by the specialist.
1 for the stabilization of the
3
• SacroLoc must only be worn in accordance with the specifications
contained in these instructions and used for the areas of application
(places of use) listed.
• No product liability is accepted in the event of improper use.
• The suitability and use of the orthosis
determined by a physician. If wearing the orthosis
feels uncomfortable, check size adjustments and application technique,
seek medical advice, and refrain from further use if necessary. Side
effects for the mother and fetus are not known.
• Only a specialist 2 may provide instruction.
• Use in combination with other products, e. g. as part of compression
treatment (medical compression stockings), must be discussed
beforehand with your physician.
• The SacroLoc is to be worn under your T­shirt or undershirt.
• If your symptoms get worse or you notice unusual changes to your
body, please contact your physician without delay.
• Avoid the use of ointments, lotions or any substances including grease
or acids.
• Side effects involving the body as a whole have not been reported
to date. Correct fitting is assumed. Do not put the SacroLoc on too
tightly as this could lead to local pressure symptoms. In rare cases,
constriction of blood vessels and nerves may occur. For this reason,
check the fit of the product if you feel unpleasant pressure and consult
the specialist in this regard or for general questions about handling.
• Caution: When loosening the straps or tensioning and fastening
systems, or when removing the product or adjusting configured
limitations of movement, there is not sufficient support / sufficient
protection of the body part requiring treatment. In this case, particularly
avoid placing any strain on this body part.
• If you would like to use your Bauerfeind product due to acute
symptoms / injuries, make sure to obtain and follow the advice of
a medical professional before first using the product. Restrictions
may exist given the specific indication which the specialist retailer
can clarify. In particular, the ability to operate vehicles, other means
of transport or machinery may be limited. In case of doubt, we
recommend temporarily refraining from the activities mentioned above.
Use during pregnancy
The fundamental suitability and use of the orthosis
is to be determined by a physician. If you should experience any
discomfort while wearing the orthosis
remove the orthosis and consult your physician without delay. They will
decide on whether and how you should continue using the product. Size
adjustment and donning technique should be practiced and reviewed
regularly with a trained specialist.
Contraindications
Hypersensitivity reactions harmful to health have not been reported
to date. In the following conditions such aids should only be fitted and
applied after consultation with your physician:
• Skin disorders / injuries in the relevant part of the body, particularly
if inflammation is present. Likewise, any raised scars with swelling,
redness and excessive heat build­up
• Impaired sensation and movement disorders, e. g. in the case of
diabetes mellitus
Area of use
A – Back pad (massage cushion)
B – Right half of the fastening with finger pockets
C – Left half of the fastening with finger pockets
D – Tensioning straps
Putting the product on
1 Position the orthosis 1 centrally on the pelvis, ensuring that the upper
1
edge of the orthosis is no higher than the upper edge of the iliac crest
2
and below the waist. Then slide your fingers downward into the
finger pockets provided on the fastening and steadily pull the fastening
forward. 3 Then press the left half of the fastening onto your stomach
and position the right half of the fastening on top of the left half so
that it can be fastened to it on the left­hand side. When fastening the
two halves, pull your fingers out of the left­hand finger pocket first and
then out of the right­hand one.
straps and pull them forward, steadily and at the same time, until the
desired level of tension (stabilization) is achieved.
tensioning straps close together on the large fastening.
Care instructions
Note: Never expose the SacroLoc to direct heat (e. g. heater, sunlight, in
your car, etc.)! This may cause damage to the material, which can impair
the effectiveness of the SacroLoc.
1 during pregnancy is to be
1
during pregnancy
1
during pregnancy
1 during pregnancy, immediately
4 Then take hold of the two tensioning
5 Then fasten the two