How to Use Aquacel™ Ag Surgical Dressings
What are Aquacel™ Ag Surgical dressings?
The dressing absorbs wound fluid and bacteria, providing a moist wound healing environment.
The ionic silver in the dressing helps reduce the risk of wound infection.
Please note: The information provided here is based on the instructions for use and is intended to offer you additional support when you need it. This should not replace any instruction given to you by your healthcare professional.
PRODUCT DESCRIPTION
Aquacel™ Ag Surgical cover dressing is a sterile post-operative dressing comprising of
an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and
1.2% ionic silver stitch bonded with nylon and elastane yarns. The pad is held in place
between a top layer of Hydrocolloid which is bound to an outer polyurethane film and a
windowed skin contact layer consisting of polyurethane film sandwiched between two
further layers of Hydrocolloid.
The outer polyurethane film of Aquacel™ Ag Surgical cover dressing provides a bacterial
and viral barrier to reduce the risk of infection provided the dressing remains intact and
there is no leakage.
The 1.2% ionic silver in the dressing helps reduce the risk of wound infection.
This product contains porcine gelatine.
INTENDED USE
Aquacel™ Ag Surgical Cover Dressings have been designed to be used as a primary
dressing.
Aquacel™ Ag Surgical Cover Dressings may be used with the direction of a healthcare
professional, for the management of acute, surgical wounds which are at risk of infection
or show signs of infection.
INTENDED USERS
Aquacel™ Ag Surgical Cover Dressings are intended to be used by Healthcare
Professionals.
TARGET PATIENT POPULATION
Aquacel™ Ag Surgical Cover Dressings are intended to be worn by patients who have
undergone surgery which are at risk of infection.
CLINICAL BENEFITS
Aquacel™ Ag Surgical Cover Dressings provide a physical waterproof, bacterial, and viral
barrier to protect the wound.
Aquacel™ Ag Surgical Cover Dressings absorb wound fluid and bacteria, providing a
moist wound healing environment, whilst contouring to the wound/sutures/staples and
removing dead-space between the wound and dressing interface.
Aquacel™ Ag Surgical Cover Dressings effectively kill bacteria, yeasts and moulds
providing protection against surgical site infection.
Aquacel™ Ag Surgical Cover Dressings are flexible to allow a full range of movement
whilst remaining comfortable to the wearer.
INDICATIONS
Aquacel™ Ag Surgical Cover Dressings are indicated for the management of acute,
surgical wounds which are at risk of infection or show signs of infection.
CONTRAINDICATIONS
Aquacel™ Ag Surgical Cover Dressings should not be used on individuals who are
sensitive to or who had an allergic reaction to the dressing or any of its components
including colophony or its derivatives.
PRECAUTIONS AND WARNINGS
• Sterility is guaranteed unless the pouch is damaged or opened prior to use. Do not use
the device if the packaging is damaged or open prior to use and dispose of the device
according to local regulations.
• Aquacel™ Ag Surgical Cover Dressings are for single use only and should not be
re-used. Reuse may lead to increased risk of infection and cross-contamination and
delayed healing.
• This dressing should not be used with other wound care products without first
consulting a healthcare professional.
• Aquacel™ Ag Surgical Cover Dressings are not compatible with oil-based products
• Due to the sterilisation process there may be a slight odour on opening the primary
packaging.
• Clinicians/Healthcare professionals should be aware that there are very limited data on
prolonged and repeated use of silver containing products, particularly in children and
neonates.
• A healthcare professional should be consulted if any of the following are observed
during dressing changes, irritation (reddening, inflammation), maceration (whitening
of skin), hyper-granulation (excess tissue formation), signs of infection (increased pain,
bleeding, warmth/redness of surrounding tissue, wound exudate), or a change in
wound colour and/or odour.
• Aquacel™ Ag Surgical Cover Dressings are designed to be MRI-Safe.
• Do not apply the dressing under tension.
• Aquacel™ Ag Surgical Cover Dressings are not designed as a replacement to
primary closure methods such as staples or sutures.
• Aquacel™ Ag Surgical Cover Dressings are not designed to be cut.
• It has been observed that silver containing products may cause skin discoloration
following prolonged use, however this is often temporary and will reverse when silver
dressing usage is stopped
• After use, this product may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and applicable local state and federal laws
and regulations.
• If during the use of this device or as a result of its use a serious incident has occurred,
please report it to the manufacturer and to the competent authority of the Member
State in which the user and/or patient is established.
• Aquacel™ Ag Surgical Cover Dressings are water resistant however, should not be
submerged during bathing or swimming.
ASSOCIATED PRODUCT & THERAPIES
Aquacel™ Ag Surgical Cover Dressings are not designed to be used in conjunction
with any other products or therapies however, clinical judgement should be used to
determine appropriate use where casts or splints are being applied.
CONTACT AND DURATION OF USE
Aquacel™ Ag Surgical Cover Dressings can be worn for up to 7 days, dressings should be
changed earlier if clinically indicated. The requirement for Aquacel™ Ag Surgical Cover
Dressings should be re-assessed after 14 days and alternative wound management
considered where appropriate.
DIRECTIONS FOR USE
To dress knee incisions. knee should be approximately at a 30-degree angle for
optimal dressing application.
1. Before applying the dressing, cleanse the wound/incision site with an appropriate
wound cleanser, rinse well with sterile saline and dry the surrounding skin.
2. Choose a dressing size to ensure direct contact between the wound/incision and the
Hydrofiber™ technology pad.
3. Remove the dressing from the sterile pack
4. Initially remove 3/4 of the backing paper from along the length of the dressing
minimising finger contact with the central pad and the adhesive surface. Place at one
side of the wound/incision line and gently roll the dressing over the wound/incision
line and mould into place.
5. Remove the remaining 1/4 backing paper and gently mould the dressing over the
wound/incision line. Mould the dressing in place for a secure adhesion. Do not stretch.
6. The translucent polyurethane and hydrocolloid backing materials allows the clinician
to monitor the central Hydrofiber™ technology pad and assess when the dressing
needs to be changed. The dressing can be left in place for up to 7 days subject to
regular clinical assessment and local dressing protocol.
7. All wounds/incisions should be monitored frequently. Remove Aquacel™ Ag Surgical
cover dressing when clinically indicated (i.e. leakage, excessive bleeding, suspicion of
infection or at 7 days).
Dressing Removal
To remove the dressing, press down on the skin with one hand and carefully lift an edge
of the dressing with your other hand. Stretch the dressing to break the adhesive seal and
remove.
Store at room temperature (10°C - 25°C/50°F - 77°F). Keep dry.
https://ec.europa.eu/tools/eudamed. This is the Summary of Safety and Clinical
Performance (SSCP) location after the launch of European Database on Medical Devices/
EUDAMED.
If further information or guidance is needed, or to report an adverse event, please
contact ConvaTec. Contact details can be found at www.convatec.com or use the contact
details at the end of this document.
Made in Dominican Republic
© 2022 ConvaTec Inc.
™ indicates a trademark of ConvaTec Inc.
How to apply and remove Aquacel™ Ag Surgical (Hip)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a wound located on the Hip.
How to apply and remove Aquacel™ Ag Surgical (Knee)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a wound located on the Knee.
How to apply and remove Aquacel™ Ag Surgical (Sternum)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a Sternal wound.
How to apply and remove Aquacel™ Ag Surgical (C-section)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a C-section wound.
How to apply and remove Aquacel™ Ag Surgical (Pacemaker)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with Pacemaker wound.
PRODUCT DESCRIPTION
Aquacel™ Ag Surgical cover dressing is a sterile post-operative dressing comprising of
an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and
1.2% ionic silver stitch bonded with nylon and elastane yarns. The pad is held in place
between a top layer of Hydrocolloid which is bound to an outer polyurethane film and a
windowed skin contact layer consisting of polyurethane film sandwiched between two
further layers of Hydrocolloid.
The outer polyurethane film of Aquacel™ Ag Surgical cover dressing provides a bacterial
and viral barrier to reduce the risk of infection provided the dressing remains intact and
there is no leakage.
The 1.2% ionic silver in the dressing helps reduce the risk of wound infection.
This product contains porcine gelatine.
INTENDED USE
Aquacel™ Ag Surgical Cover Dressings have been designed to be used as a primary
dressing.
Aquacel™ Ag Surgical Cover Dressings may be used with the direction of a healthcare
professional, for the management of acute, surgical wounds which are at risk of infection
or show signs of infection.
INTENDED USERS
Aquacel™ Ag Surgical Cover Dressings are intended to be used by Healthcare
Professionals.
TARGET PATIENT POPULATION
Aquacel™ Ag Surgical Cover Dressings are intended to be worn by patients who have
undergone surgery which are at risk of infection.
CLINICAL BENEFITS
Aquacel™ Ag Surgical Cover Dressings provide a physical waterproof, bacterial, and viral
barrier to protect the wound.
Aquacel™ Ag Surgical Cover Dressings absorb wound fluid and bacteria, providing a
moist wound healing environment, whilst contouring to the wound/sutures/staples and
removing dead-space between the wound and dressing interface.
Aquacel™ Ag Surgical Cover Dressings effectively kill bacteria, yeasts and moulds
providing protection against surgical site infection.
Aquacel™ Ag Surgical Cover Dressings are flexible to allow a full range of movement
whilst remaining comfortable to the wearer.
INDICATIONS
Aquacel™ Ag Surgical Cover Dressings are indicated for the management of acute,
surgical wounds which are at risk of infection or show signs of infection.
CONTRAINDICATIONS
Aquacel™ Ag Surgical Cover Dressings should not be used on individuals who are
sensitive to or who had an allergic reaction to the dressing or any of its components
including colophony or its derivatives.
PRECAUTIONS AND WARNINGS
• Sterility is guaranteed unless the pouch is damaged or opened prior to use. Do not use
the device if the packaging is damaged or open prior to use and dispose of the device
according to local regulations.
• Aquacel™ Ag Surgical Cover Dressings are for single use only and should not be
re-used. Reuse may lead to increased risk of infection and cross-contamination and
delayed healing.
• This dressing should not be used with other wound care products without first
consulting a healthcare professional.
• Aquacel™ Ag Surgical Cover Dressings are not compatible with oil-based products
• Due to the sterilisation process there may be a slight odour on opening the primary
packaging.
• Clinicians/Healthcare professionals should be aware that there are very limited data on
prolonged and repeated use of silver containing products, particularly in children and
neonates.
• A healthcare professional should be consulted if any of the following are observed
during dressing changes, irritation (reddening, inflammation), maceration (whitening
of skin), hyper-granulation (excess tissue formation), signs of infection (increased pain,
bleeding, warmth/redness of surrounding tissue, wound exudate), or a change in
wound colour and/or odour.
• Aquacel™ Ag Surgical Cover Dressings are designed to be MRI-Safe.
• Do not apply the dressing under tension.
• Aquacel™ Ag Surgical Cover Dressings are not designed as a replacement to
primary closure methods such as staples or sutures.
• Aquacel™ Ag Surgical Cover Dressings are not designed to be cut.
• It has been observed that silver containing products may cause skin discoloration
following prolonged use, however this is often temporary and will reverse when silver
dressing usage is stopped
• After use, this product may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and applicable local state and federal laws
and regulations.
• If during the use of this device or as a result of its use a serious incident has occurred,
please report it to the manufacturer and to the competent authority of the Member
State in which the user and/or patient is established.
• Aquacel™ Ag Surgical Cover Dressings are water resistant however, should not be
submerged during bathing or swimming.
ASSOCIATED PRODUCT & THERAPIES
Aquacel™ Ag Surgical Cover Dressings are not designed to be used in conjunction
with any other products or therapies however, clinical judgement should be used to
determine appropriate use where casts or splints are being applied.
CONTACT AND DURATION OF USE
Aquacel™ Ag Surgical Cover Dressings can be worn for up to 7 days, dressings should be
changed earlier if clinically indicated. The requirement for Aquacel™ Ag Surgical Cover
Dressings should be re-assessed after 14 days and alternative wound management
considered where appropriate.
DIRECTIONS FOR USE
To dress knee incisions. knee should be approximately at a 30-degree angle for
optimal dressing application.
1. Before applying the dressing, cleanse the wound/incision site with an appropriate
wound cleanser, rinse well with sterile saline and dry the surrounding skin.
2. Choose a dressing size to ensure direct contact between the wound/incision and the
Hydrofiber™ technology pad.
3. Remove the dressing from the sterile pack
4. Initially remove 3/4 of the backing paper from along the length of the dressing
minimising finger contact with the central pad and the adhesive surface. Place at one
side of the wound/incision line and gently roll the dressing over the wound/incision
line and mould into place.
5. Remove the remaining 1/4 backing paper and gently mould the dressing over the
wound/incision line. Mould the dressing in place for a secure adhesion. Do not stretch.
6. The translucent polyurethane and hydrocolloid backing materials allows the clinician
to monitor the central Hydrofiber™ technology pad and assess when the dressing
needs to be changed. The dressing can be left in place for up to 7 days subject to
regular clinical assessment and local dressing protocol.
7. All wounds/incisions should be monitored frequently. Remove Aquacel™ Ag Surgical
cover dressing when clinically indicated (i.e. leakage, excessive bleeding, suspicion of
infection or at 7 days).
Dressing Removal
To remove the dressing, press down on the skin with one hand and carefully lift an edge
of the dressing with your other hand. Stretch the dressing to break the adhesive seal and
remove.
Store at room temperature (10°C - 25°C/50°F - 77°F). Keep dry.
https://ec.europa.eu/tools/eudamed. This is the Summary of Safety and Clinical
Performance (SSCP) location after the launch of European Database on Medical Devices/
EUDAMED.
If further information or guidance is needed, or to report an adverse event, please
contact ConvaTec. Contact details can be found at www.convatec.com or use the contact
details at the end of this document.
Made in Dominican Republic
© 2022 ConvaTec Inc.
™ indicates a trademark of ConvaTec Inc.
How to apply and remove Aquacel™ Ag Surgical (Hip)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a wound located on the Hip.
How to apply and remove Aquacel™ Ag Surgical (Knee)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a wound located on the Knee.
How to apply and remove Aquacel™ Ag Surgical (Sternum)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a Sternal wound.
How to apply and remove Aquacel™ Ag Surgical (C-section)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with a C-section wound.
How to apply and remove Aquacel™ Ag Surgical (Pacemaker)
We’ve created a short film to help guide you on how to apply and remove Aquacel™ Ag Surgical, when treating a patient with Pacemaker wound.
PRODUCT DESCRIPTION
Aquacel™ Ag Surgical cover dressing is a sterile post-operative dressing comprising of
an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and
1.2% ionic silver stitch bonded with nylon and elastane yarns. The pad is held in place
between a top layer of Hydrocolloid which is bound to an outer polyurethane film and a
windowed skin contact layer consisting of polyurethane film sandwiched between two
further layers of Hydrocolloid.
The outer polyurethane film of Aquacel™ Ag Surgical cover dressing provides a bacterial
and viral barrier to reduce the risk of infection provided the dressing remains intact and
there is no leakage.
The 1.2% ionic silver in the dressing helps reduce the risk of wound infection.
This product contains porcine gelatine.
INTENDED USE
Aquacel™ Ag Surgical Cover Dressings have been designed to be used as a primary
dressing.
Aquacel™ Ag Surgical Cover Dressings may be used with the direction of a healthcare
professional, for the management of acute, surgical wounds which are at risk of infection
or show signs of infection.
INTENDED USERS
Aquacel™ Ag Surgical Cover Dressings are intended to be used by Healthcare
Professionals.
TARGET PATIENT POPULATION
Aquacel™ Ag Surgical Cover Dressings are intended to be worn by patients who have
undergone surgery which are at risk of infection.
CLINICAL BENEFITS
Aquacel™ Ag Surgical Cover Dressings provide a physical waterproof, bacterial, and viral
barrier to protect the wound.
Aquacel™ Ag Surgical Cover Dressings absorb wound fluid and bacteria, providing a
moist wound healing environment, whilst contouring to the wound/sutures/staples and
removing dead-space between the wound and dressing interface.
Aquacel™ Ag Surgical Cover Dressings effectively kill bacteria, yeasts and moulds
providing protection against surgical site infection.
Aquacel™ Ag Surgical Cover Dressings are flexible to allow a full range of movement
whilst remaining comfortable to the wearer.
INDICATIONS
Aquacel™ Ag Surgical Cover Dressings are indicated for the management of acute,
surgical wounds which are at risk of infection or show signs of infection.
CONTRAINDICATIONS
Aquacel™ Ag Surgical Cover Dressings should not be used on individuals who are
sensitive to or who had an allergic reaction to the dressing or any of its components
including colophony or its derivatives.
PRECAUTIONS AND WARNINGS
• Sterility is guaranteed unless the pouch is damaged or opened prior to use. Do not use
the device if the packaging is damaged or open prior to use and dispose of the device
according to local regulations.
• Aquacel™ Ag Surgical Cover Dressings are for single use only and should not be
re-used. Reuse may lead to increased risk of infection and cross-contamination and
delayed healing.
• This dressing should not be used with other wound care products without first
consulting a healthcare professional.
• Aquacel™ Ag Surgical Cover Dressings are not compatible with oil-based products
• Due to the sterilisation process there may be a slight odour on opening the primary
packaging.
• Clinicians/Healthcare professionals should be aware that there are very limited data on
prolonged and repeated use of silver containing products, particularly in children and
neonates.
• A healthcare professional should be consulted if any of the following are observed
during dressing changes, irritation (reddening, inflammation), maceration (whitening
of skin), hyper-granulation (excess tissue formation), signs of infection (increased pain,
bleeding, warmth/redness of surrounding tissue, wound exudate), or a change in
wound colour and/or odour.
• Aquacel™ Ag Surgical Cover Dressings are designed to be MRI-Safe.
• Do not apply the dressing under tension.
• Aquacel™ Ag Surgical Cover Dressings are not designed as a replacement to
primary closure methods such as staples or sutures.
• Aquacel™ Ag Surgical Cover Dressings are not designed to be cut.
• It has been observed that silver containing products may cause skin discoloration
following prolonged use, however this is often temporary and will reverse when silver
dressing usage is stopped
• After use, this product may be a potential biohazard. Handle and dispose of in
accordance with accepted medical practice and applicable local state and federal laws
and regulations.
• If during the use of this device or as a result of its use a serious incident has occurred,
please report it to the manufacturer and to the competent authority of the Member
State in which the user and/or patient is established.
• Aquacel™ Ag Surgical Cover Dressings are water resistant however, should not be
submerged during bathing or swimming.
ASSOCIATED PRODUCT & THERAPIES
Aquacel™ Ag Surgical Cover Dressings are not designed to be used in conjunction
with any other products or therapies however, clinical judgement should be used to
determine appropriate use where casts or splints are being applied.
CONTACT AND DURATION OF USE
Aquacel™ Ag Surgical Cover Dressings can be worn for up to 7 days, dressings should be
changed earlier if clinically indicated. The requirement for Aquacel™ Ag Surgical Cover
Dressings should be re-assessed after 14 days and alternative wound management
considered where appropriate.
DIRECTIONS FOR USE
To dress knee incisions. knee should be approximately at a 30-degree angle for
optimal dressing application.
1. Before applying the dressing, cleanse the wound/incision site with an appropriate
wound cleanser, rinse well with sterile saline and dry the surrounding skin.
2. Choose a dressing size to ensure direct contact between the wound/incision and the
Hydrofiber™ technology pad.
3. Remove the dressing from the sterile pack
4. Initially remove 3/4 of the backing paper from along the length of the dressing
minimising finger contact with the central pad and the adhesive surface. Place at one
side of the wound/incision line and gently roll the dressing over the wound/incision
line and mould into place.
5. Remove the remaining 1/4 backing paper and gently mould the dressing over the
wound/incision line. Mould the dressing in place for a secure adhesion. Do not stretch.
6. The translucent polyurethane and hydrocolloid backing materials allows the clinician
to monitor the central Hydrofiber™ technology pad and assess when the dressing
needs to be changed. The dressing can be left in place for up to 7 days subject to
regular clinical assessment and local dressing protocol.
7. All wounds/incisions should be monitored frequently. Remove Aquacel™ Ag Surgical
cover dressing when clinically indicated (i.e. leakage, excessive bleeding, suspicion of
infection or at 7 days).
Dressing Removal
To remove the dressing, press down on the skin with one hand and carefully lift an edge
of the dressing with your other hand. Stretch the dressing to break the adhesive seal and
remove.
Store at room temperature (10°C - 25°C/50°F - 77°F). Keep dry.
https://ec.europa.eu/tools/eudamed. This is the Summary of Safety and Clinical
Performance (SSCP) location after the launch of European Database on Medical Devices/
EUDAMED.
If further information or guidance is needed, or to report an adverse event, please
contact ConvaTec. Contact details can be found at www.convatec.com or use the contact
details at the end of this document.
Made in Dominican Republic
© 2022 ConvaTec Inc.
™ indicates a trademark of ConvaTec Inc.
