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INSTRUCTIONS FOR USE
DESCRIPTION
The SAFEGUARD FOCUS™ Compression Device is a sterile, single use
disposable device. The SAFEGUARD FOCUS has a sterile dressing
with a clear window over the compression balloon that facilitates
visibility of the access site without removal or manipulation of
the device. A valve on the end of the flexible fill tube enables the
included syringe with adapted connector to be connected to
inflate the balloon with air to provide pressure to the desired site.
The SafeGuard FOCUS comes in a pressure-sensitive self-adhesive
version and an adhesive-free version with hook and loop straps.
INDICATIONS FOR USE
The SAFEGUARD FOCUS dressing provides compression over
closed surgical sites (to and including pacemaker and ICD pockets)
in the immediate post-operative period.
CONTRAINDICATIONS
•
The adhesive portion of the SAFEGUARD device should not be
used over damaged skin.
•
Not indicated for femoral artery compression.
CLINCAL BENEFITS
The SAFEGUARD FOCUS assists in providing compression to closed
surgical sites in the immediate post-operative period.
PRECAUTIONS
•
This device should be used by clinicians with adequate training
in the use of the device.
•
In the EU - Any serious incident that has occurred in relation
to the device should be reported to the manufacturer and the
competent authority of the applicable member state.
WARNINGS
•
Do not leave the SafeGuard FOCUS on for an inappropriately
long period of time as tissue damage may occur.
•
Do not expose the SafeGuard FOCUS to organic solvents, as
they may cause damage to the device.
•
Over-inflation above 120 mL's of air, the balloon may burst,
detach or compromise the adhesive or fastening properties
of the device.
•
Do not attempt to reposition adhesive. Adhesive only sticks
properly on first application.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination of
the device may lead to injury, illness or death of the patient.
POTENTIAL COMPLICATIONS/RESIDUAL RISKS
Embolism, soft tissue injury, hematoma, local bleeding, local
venous thrombosis, nerve damage, pain or numbness, infection,
allergic reac tion, vasoconstric tion and venous f istula or
pseudoaneurysm.
INSTRUCTIONS FOR USE
PREPARATION:
1.
After closure of surgical site ensure surrounding skin is clean
and dry.
English
PLACEMENT: ADHESIVE TYPE
2.
Remove backing material from adhesive.
3.
Align balloon with desired location of compression.
4.
Apply adhesive to surrounding skin.
PLACEMENT: ADHESIVE-FREE TYPE
2.
Attach printed end of strap to the side of balloon border.
3.
Wrap long printed strap around chest of patient under each
arm.
4.
Align balloon with desired location of compression and pull
strap tight and attach on opposite side.
5.
Attach short strap to the underside of the long strap on the
patient's back.
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