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• Products in Avance Solo Adapt NPWT System contain small parts
which could be a potential choking hazard. Keep this device out of
the reach of children.
• Keep this device out of the reach of pets.
5.
Precautions
• Before starting therapy, evaluate the patient's nutritional status
and address severe malnutrition. Also consider the patient's size
and weight.
• Signs of possible infection or complications must be addressed
immediately. Monitor the device, wound, surrounding skin, and
patient status accordingly to ensure effective and safe treatment
and patient comfort.
• For patients with ischemic condition or at application of a
circumferential dressing, extra monitoring of wound status is
required to avoid risk of compromised circulation.
• Multiple layers of film or addition of an occlusive dressing over
the Avance Solo Adapt Film may decrease the breathability, which
may increase the risk of maceration.
• Application of certain skin protection products or using cleansing
products prior to the application of Avance Solo Adapt Film,
can affect the ability of the film to adhere securely and create
sufficient sealing.
• Do not stretch Avance Solo Adapt Film since it may cause damage
to the surrounding skin when negative pressure is applied.
• Do not use the products on patient and/or user with known
hypersensitivity to the materials/components of the products.
• Ingrowth of tissue may occur if Avance Solo Adapt Foam is not
changed in accordance with recommendations or as appropriate
for the wound condition of the individual patient.
• Consider use of non-adherent wound contact layer to protect
fragile tissue.
• Do not place Avance Solo Adapt Foam onto intact skin or non-
protected superficial or retention sutures.
• For daily hygiene routines do not expose the dressing to extensive
contact with water.
• Avance Solo Adapt Foam and Avance Solo Adapt Film shall only be
applied and changed by healthcare professional.
• No modification of this device (foam, film and transfer port)
outside the instructions for use is allowed as modifications may
significantly compromise the ability of the system to deliver
therapy.
• Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film, shall only be used within the Avance Solo Adapt NPWT
System.
• Do not cut the tubing or detach tubing from the canister.
• Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are provided sterile. Do not use if the sterile barrier is
damaged or has been opened prior to use. Do not re-sterilize.
• Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are single use.
• Do not reuse Avance Solo Adapt Foam, Film and Transfer Port and
Avance Solo Adapt Film. If reused, performance of the product
may deteriorate and/or cross contamination may occur.
• Always clamp the transfer port tubing and the canister tubing
before disconnecting them.
6.
Instructions for use
6.1. To consider before use
Avance Solo Adapt Foam, Film and Transfer Port and Avance Solo
Adapt Film are applicable for use on low to moderately exuding
wounds up to the size of the Avance Solo Adapt Foam. The maximum
allowed wound size area shall not exceed the size of Avance Solo
Adapt Foam (67 cm
/ 10.4 inch2). Do not use more foam than what is
2
supplied in one Avance Solo Adapt Foam, Film, Transfer port kit.
Low exuding wounds are considered to be up to 0.6 g/ cm
area/ 24 hours (0.6 g/ 0.16 inch2 wound area/ 24 hours). Moderate
exuding wounds are considered to be up to 1.1 g/ cm
wound area/
2
24 hours (1.1 g/ 0.16 inch2 wound area/ 24 hours). 1 g exudate is
considered equal to 1 ml.
The film shall cover the foam and adhere to the surrounding skin
with a margin of 4-5 cm/ 1.6- 2.0 inches. It is preferable to apply the
film as a single piece. In case several pieces are required, ensure
overlap of the pieces of 4-5 cm/ 1.6- 2.0 inches for proper adhesion.
Minimize number of overlaps to avoid moisture build up under the
film and/or the risk of air leakage.
If there is a clinical need to treat an underlying pathology of venous
insufficiency with compression therapy, ensure that Avance Solo
Adapt NPWT System do not induce any pressure points that may
result in discomfort or tissue damage to the patient. Do not place
the tubing and transfer port under any form of compression
garment or bandage.
6.2. Pump Set Up
For pump set up see HEALTH CARE PROFESSIONAL Instructions for
use provided with Avance Solo Adapt NPWT System.
6.3. Dressing Application Procedure
To apply, use clean/aseptic or sterile techniques in accordance with
local protocol.
1. Cleanse and debride the wound bed in accordance with local
protocol.
2. Cleanse the peri wound skin and pat dry. Apply skin protector/
skin sealant on peri wound skin if required. Certain skin
protection products or skin lotions can affect the ability of the
film to adhere securely.
3. Eliminate or cover sharp edges and bone fragments with non-
adherent wound contact layer due to risk of puncturing organs or
blood vessels while under negative pressure. Document the use
of wound contact layer in the patient's notes.
4. Cut the foam into an appropriate size corresponding to the
dimensions of the wound cavity.
5. Do not cut the foam above the wound site as fragments may fall
into the wound. Make sure that no foam fragments are left in the
wound or on wound edges.
6. Sufficiently fill the wound cavity without overpacking, as this
could damage tissue, affect exudate removal, or affect delivery
of negative pressure. Ensure contact between all pieces of foam
placed in the wound. Consider use of a non-adherent wound
contact layer to protect fragile tissue.
7. Do not place Avance Solo Adapt Foam onto intact skin or non-
protected superficial or retention sutures.
8. Document the number of pieces of foam used in the patient's
notes.
9. Cut the film to the appropriate size allowing a margin of 4-5 cm/
1.6-2.0 inches onto surrounding skin.
10. Grip the center part of the release film and pull to expose the
adhesive surface.
11. Without stretching, position the film centrally over the wound.
12. Gently remove the remaining release films, smoothing down the
film to minimize wrinkles and creases. Do not stretch the film
during application as this may cause damage to the surrounding
skin when negative pressure is applied.
13. Ensure that the film is in contact with the foam.
14. Contamination of silicone adhesive on top of the film prior to
application of the Avance Solo Adapt Transfer Port can affect the
ability of the Avance Solo Adapt Transfer Port to adhere securely.
15. Cut a hole, < 2 cm/ 0.8 inch in diameter, in the film covering the
wound cavity.
16. Remove the release film on the transfer port and apply it directly
over the cut hole in the film. Press gently to fixate it on top of
wound
the film. For wounds smaller than the transfer port, protect peri
2
wound skin from imprints and tissue damage, with Avance Solo
Adapt Film and Avance Solo Adapt Foam. The tubing should be
laid to prevent bends and kinks of the tubing and to avoid risk of
imprints and discomfort to the patient.
17. Connect the canister tubing to the transfer port tubing using the
connectors on the end of each tubing. Ensure that the tubing is
not clamped.
18. To start therapy, press and hold the green pump start button,
release after two (2) seconds so that the pump activates and the
green start button flashes. Negative pressure shall be achieved
within two (2) minutes after pump start.
19. Once the negative pressure is applied, the dressing will contract
and be firm to the touch. A wrinkled appearance of the dressing
indicates that negative pressure has been achieved and
maintained.
20. If negative pressure is hard to achieve, adjust film or press
around the edges to improve contact with the skin. Take care to
minimize wrinkles and gaps. Consider using additional Avance
Solo Adapt Film or start over and reseal, if necessary.
6.4. Frequency of dressing change
Avance Solo Adapt Foam, Film and Transfer Port should be changed
every 48 to 72 hours, but no less than 3 times a week, or as
instructed by healthcare professional.
NOTE: Ingrowth of tissue may occur if the foam is not changed in
accordance with recommendations or as appropriate for the wound
condition of the individual patient.
6.5. Dressing removal procedure
To remove the dressing, perform the following steps:
21. If the pump is active, pause therapy by pressing down the green
start button, release after two (2) seconds.
22. Block both the canister tubing and transfer port tubing by
positioning the slide clamps next to the connector and slide across
the tubing until secured.
23. Disconnect the canister tubing from the transfer port tubing by
squeezing the connector from both sides and pull apart.
24. Gently peel back one corner of the film and stretch to facilitate
breakage of the seal. Proceed with this technique (in the direction of
hair growth) until the film is completely removed.
25. Remove the foam gently. If adherence of foam to wound bed is
observed, consider moistening the foam. Make sure no fragments
are left in the wound.
If the patient experiences pain during dressing removal, consider
the use of pain relief medication, as instructed by a healthcare
professional, when changing dressings. Consult patient's notes to
ensure that all materials used have been removed.
6.6. Changing the canister, changing the batteries and daily use
For instructions how to change the canister or the batteries and for
daily use see HEALTH CARE PROFESSIONAL Instructions for use
provided with Avance Solo Adapt NPWT System.
6.7. Disposal
Avance Solo Adapt Foam, Film and Transfer Port and Avance
Solo Adapt Film are single use products. After use, dispose of the
products as clinical waste in accordance with local regulations.
For more information about safe disposal, see www.molnlycke.
com/wastehandling or contact your local Mölnlycke Health Care
representative.
7.
Avance Solo Adapt NPWT System Indicators, Alarms and
Troubleshooting
For system indicators for normal use, alarms and troubleshooting
HEALTH CARE PROFESSIONAL Instructions for use provided with
Avance Solo Adapt NPWT System.
8.
Caution
Avance Solo Adapt Foam, Film and Transfer Port and single
packed Avance Solo Adapt Film must be used in accordance with
these Instructions for Use in combination with the HEALTH CARE
PROFESSIONAL Instructions for use provided with Avance Solo
Adapt NPWT System. Read the instructions before using the system
and have them available during use. Failure to read and understand
these instructions may lead to misuse of the system and improper
performance. These instructions are a general guide for the use
of the product. Specific medical situations must be addressed by a
healthcare professional.
9.
Other information
If any serious incident has occurred in relation to Avance Solo Adapt
Foam, Film and Transfer Port or Avance Solo Adapt Film, it should
be reported to Mölnlycke Health Care.
Avance
®
and Safetac
®
are registered trademarks of
Mölnlycke Health Care AB
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