Thuasne KIT BIFLEX Manual De Instrucciones página 4

en
This product is a medical device supplied on medical prescription. To fit it, the aid
of a health professional or other person trained in the application of bandages is
required. Read the instruction leaflet carefully.
The BIFLEX KIT consists of two bandages:
Bandage No. 1:
Compression bandage to provide support and protect the skin - short-stretch elastic bandage
(stretch of between 10 and 100%) - latex-free (polyester microfibre + viscose + elastane).
Bandage No. 1 protects the skin and bony prominences and supports the limb.
Bandage No. 2:
Compression bandage - short-stretch elastic bandage (maximum stretch of between 10 and
100%) - latex-free (viscose - polyester - polyamide - elastane).
Bandage No. 2 provides the level of pressure required for treatment of the venous ulcer.
Venous compression is an essential component in the venous ulcer healing process.
The BIFLEX KIT can be left in place on the leg day and night, for a maximum of 7 days.
At the start of treatment, it should be changed and/or repositioned at each local dressing change,
i.e. as often as required by the exudate level, or whenever the limb volume changes (oedema).
The bandages are washable and reusable.
It is recommended that treatment be continued until the venous ulcer has healed completely.
The continued use of a compression device (stockings or bandages) after healing is recommended
to prevent recurrences.
Indications:
Venous ulcer of the lower limbs (CEAP stage C6).
Contraindications:
• Arterial diseases: Peripheral arterial disease (PAD), arterial or mixed ulcer with an arterial
dominance (ankle-brachial index ABPI < 0.8 or ABPI > 1.3).
• Patients suffering from advanced diabetic microangiopathy, phlegmasia cerulea dolens (painful
blue oedema with artery compression) or septic thrombosis
• Extra-anatomic bypass.
• Uncontrolled heart failure.
• Skin wounds, abscesses, furuncles, infected skin conditions.
• Allergies to any of the components in the BIFLEX KIT bandages.
Precautions:
• A Doppler ultrasound exam must be performed before using the BIFLEX KIT to ensure the
absence of any associated severe arterial disease.
• Advanced peripheral neuropathy under regular medical supervision
• In case of imbalanced diabetes, use following medical advice only and under strict supervision
• Follow the instructions of the health professional who prescribed or supplied the product.
• Do not apply directly to a wound.
• Follow your doctor's instructions with respect to application method and the amount of time
the device is worn.
• In the event of significant discomfort or unusual sensations (itching, eczema, acute pain),
remove the product and seek your doctor's advice.
• Reserved for use by one patient only.
Washing instructions:
Machine wash, without detergent or bleach.
Bandages No. 1 and No. 2:
Washable 3 times at 40°C, normal wash programme.
Dry flat, away from direct heat.
Do not bleach.
Do not tumble dry.
Do not iron.
Do not dry clean.
Calibration:
The calibration system makes it possible to control the tension of the bandage.
The bandage has been applied with the correct tension when each rectangle is transformed into
a square.
The bandage has been correctly applied when the square is completely covered.
The calibration system and application method are identical for the two bandages, thereby
guaranteeing optimum application reproducibility and compliance with the correct pressure
required for treatment. (Pressure at the ankle on average > 36 mmHg).
All the bandages can be repositioned on the basis of changes in limb volume.
Instructions for use - Application methods:
Before using the bandages:
Examine the shape of the leg to see whether there are any bony areas or dysmorphic features
and use protective foams or Varico cushions to give the leg an even shape.
Preferably, the Biflex kit bandages should be used after waking up in the morning or after
keeping the patient's leg raised for an hour.
Apply the bandages in the following order, holding the foot at a right angle. For anchoring the
bandage in place on the foot, apply just enough pressure to hold the bandage in place. Only use
the calibration system from the ankle upwards.
Bandage No. 1 (cf fitting diagram)
1. Position the end of the bandage flat against the base of the toes (softest side against the skin
and calibrated side visible).
2. Always include the heel.
3. Securing from the bottom.
4. Securing from the top.
5. Circular application, fully covering the square.
Finishing of the bandage, 2 fingers below the back of the knee.
Bandage No. 2 (cf fitting diagram)
1. Position the end of the bandage flat against the base of the toes, leaving bandage No. 1
protruding slightly (calibrated side visible).
The excess bandage should not be wrapped a one more time around the limb to avoid creating
a pressure peak. Either cut the excess bandage or allow it to hang loosely lengthwise on the
bandage.
How to use the bandage fasteners properly:
 - To attach the fastener:
• Press one side of the fastener into the end of the bandage to be secured.
• Gently pull the attached fastener to apply slight tension to the bandage before attaching the
other side of the fastener. Fastening will be more secure if the bandage is slightly stretched.
• Gently press the whole fastener to ensure it is firmly anchored to the bandage.
 - To remove the fastener:
• Gently raise one edge until it
It is possible that a few fibres or fluff could be left after the fastener is detached, but this does
not affect the quality of the bandage or reduce its effectiveness.
The combined action of the two bandages guarantees the required pressure level recommended
by the HAS (French Health Authority) (> 36 mmHg).
The repositionable BIFLEX KIT promotes good-quality care, comfort and patient compliance,
which are all essential elements for the success of venous ulcer treatment.
The efficacy of the BIFLEX KIT has been tested and measured for the combined application of
both bandages contained in the kit.
becomes detached (like removing
Keep this instruction leaflet.
a plaster).