Instructions For Use Applying embrace® 6.3in / 16cm Applicator

Transcription

ACTIVE SCAR DEFENSE
Instructions
For Use
embrace® Active Scar Defense is the only
preventative scar treatment of its kind.
embrace® gently draws together both
sides of a closed incision, relieving skin
tension which is clinically shown to limit
scar tissue formation and significantly
improve scar appearance.
6.3
in / 16cm APPLICATOR & DRESSING
6.3in
/ 16cm Applicator & Dressing
Visual Guide
Tabs
Protective Liner
(plastic with
arrows)
Adhesive Dressing
(under protective
liner)
Applicator
INTENDED USE
POTENTIAL SIDE EFFECTS
Application of any surgical tape or
adhesive dressing may strip the skin upon
removal. Consult with your physician
should any of the following occur:
• Position yourself in a way that ensures
the area around the scar is as flat as
possible, allowing for a natural range of
motion once the dressing is applied.
• A mirror may help you visualize
placement of the dressing.
2 Hold the applicator with one hand and
PEEL the protective liners off and away
from adhesive dressing. Make sure
to hold the applicator on the outside
edges and DO NOT touch the exposed
adhesive dressing.
Protective Liner
Hold the
applicator on
the outside
to AVOID
touching the
adhesive.
BEFORE APPLYING embrace®
• Wash hands with soap and water.
• Clip any hairs near the application site
that might prevent the dressing from
adhering to the skin. Do not use a
manual razor as it may cause irritation.
• For external (topical) use only.
• Do not apply lotion or ointment, and
remove all makeup, as this will prevent
the dressing from properly adhering to
the skin.
• DO NOT use if you have known adverse
reactions to medical adhesives or skin
diseases that would preclude the use of
adhesive dressings.
• Thoroughly clean the scar and
surrounding area with soap and water,
followed by isopropyl alcohol, allowing
it to dry.
• The embrace® dressing is waterresistant. Short term exposure to water,
(such as showering) is OK. DO NOT
expose to water for prolonged periods
of time.
• Do not cut the dressing before or after
application as it may cause irritation.
www.neodynebio.com I embracescartherapy.com
Gently bow the applicator as shown
below. This will ensure the dressing has
no pockets or creases before you apply
it to the scar.
• Make sure you are standing upright and
still when you apply the dressing. DO
NOT twist or contort your body during
the application process.
• Do not apply if an infection is suspected.
• Not a sterile device.
Adhesive Dressing
It may be necessary to have assistance with
application if you are unable to apply in the
following manner:
CONTRAINDICATIONS
• DO NOT use on scars if infection is
suspected.
90o
IMPORTANT
• The scar is ready for embrace® once
sutures have been removed and the
area is closed and dry.
WARNINGS & PRECAUTIONS
4 HOLD the applicator (adhesive dressing
side up) on the ends so that it sits
between the thumbs and fingers.
1 Partially OPEN the applicator as shown.
• Skin irritation
• Infection and/or fever
• Allergic reaction
embrace® is intended for use in the
management of closed hyperproliferative
(hypertrophic and keloid) scars.
• Not for use on open incision lines,
injuries or abraded skin.
Applying embrace®
APPLYING embrace®
3 FOLD the side of the applicator with
the visual guide all the way back.
After folding, the visual guide side of
the applicator should be on the back
side of the adhesive dressing. Hold the
applicator on the outside ends; again
DO NOT touch the adhesive dressing.
270o
Visual
Guide
Adhesive
Dressing
5 Use the visual guide to help CENTER
AND ALIGN the dressing over the scar
with the dark stripe facing away from
the body.
Align visual guide over scar
For horizontal scars,
the tabbed end of
the applicator should
point toward the side
of the body.
For vertical scars,
the tabbed end
of the applicator
should point
downward.
Make sure scar is completely covered.
The dressing should extend at least
one half inch beyond each side of the
scar. If you need to apply more than
one dressing to completely cover the
scar, see SCARS REQUIRING MULTIPLE
DRESSINGS on the back of this insert.
For additional video guidance, please visit:
www.youtube.com/embracescartherapy
6 PRESS the adhesive dressing side of
the applicator to the skin. Do not lift
the dressing once it has made contact
with the skin, as this will damage the
dressing and prevent it from properly
adhering. As pressure is applied, the
adhesive dressing will adhere to the
skin. Make sure to press down firmly
on all edges and corners.
9 LIFT the applicator from the skin. The
dressing will remain in place over the
scar. Check the dressing to make sure it
is evenly attached. Use hands and fingers
to help smooth out any uneven areas
and ensure all corners are adhering to
the skin.
Dressing
should
completely
adhere to skin
Apply
pressure
to back of
dressing
10DISCARD the applicator, tabs, and liners.
7 PRESS AND HOLD the applicator
against the skin using one hand. With
the other hand, press and slide fingers
downward over the vertical bands,
beginning with the band closest to the
tabs. This will help ensure the dressing
is evenly applied and sits smoothly
over the scar.
Secure
dressing by
rubbing with
fingers
8 Continue to hold the applicator
FIRMLY in place with your fingers
along the visual guide dark stripe.
PULL each tab out and away from
the applicator with the opposing
hand to release the dressing from
the applicator. It is important to
keep pressure on the applicator to
ensure the dressing remains flat when
deployed onto the skin.
Pull tabs
to release
dressing onto
the skin
NOTE:
• After the initial application, the waterresistant dressing should be changed
weekly and worn for a minimum of 8
weeks.
• Certain applications may involve more
frequent changing due to high mobility,
cleansing routine, hair growth, or oil level
on the skin.
• The embrace® dressing does not offer
protection from the sun.
SCARS REQUIRING MULTIPLE DRESSINGS
For scars longer than a single dressing.
additional dressings may be used for
complete coverage.
For scars that require more than two
dressings, begin in the middle of the scar
and work outward as follows:
Apply first
dressing in the
middle of the
scar
Center the next dressing over the
uncovered part of the scar. Use the
applicator to align with the dressing
already in place. There will be an overlap
of the two dressings. Repeat these steps
until the scar is completely covered.
Removing embrace®
• Remove embrace® the evening prior to
your appointment or dressing change,
or when the edges begin to lift—up to 7
days after application.
• It is helpful to remove the dressing in
the shower using warm water and soap.
• Gently peel the dressing back at 180°,
rolling it back upon itself. Use your
other hand to apply slight pressure on
your skin as you remove the dressing.
• Do not pull quickly as skin irritation or
tearing can occur.
• If any adhesive remains, remove it with
an oil based product such as baby oil or
over-the-counter adhesive remover.
• Do not apply any lotions or ointments
to the area, and keep hairs in the bikini
area trimmed.
• Allow skin to rest for 12 to 24 hours
before reapplying embrace®.
Troubleshooting
• PROBLEM There are small sections
or channels where the dressing is not
sticking to the skin.
• SOLUTION Use hands and fingers to
help smooth out and release any air
pockets. Place hand over the dressing
for 30-60 seconds to help it adhere to
the skin.
Helpful Hints
IMPORTANT THINGS TO REMEMBER
• After initial application, embrace® should
be changed weekly and worn for a
minimum of 8 weeks.
• Do not shower 4 hours after application.
• Do not apply compression garmets or
binders for 1-2 hours after application.
• Minor redness is OK.
• Moisture or condensation under the
dressing is OK (such as after showering).
• After application, a minor wrinkly or wavy
appearance in the dressing is normal.
Wavy/wrinkly
appearance is OK
and dressing is still
effective. Redoing
the application is
NOT necessary.
• If you have redness or irritation around
the edges of the dressing, reposition it
slightly higher or lower to avoid direct
contact with the irritation when applying
the next dressing.
• If you are using embrace® after a surgery
and your scar starts to open or ooze, or if
you have an allergic reaction or blistering,
please consult your physician.
• For helpful application and removal video
guidance, please visit:
Smooth out
with fingers
to release air
pockets
Apply pressure
and hold to
help it adhere
to the skin
Neodyne Biosciences, Inc. l 127 Independence
Drive, Menlo Park, CA 94025 l 855.722.7879
embrace® is a registered trademark of Neodyne
Biosciences, Inc. © 2015 Neodyne Biosciences,
Inc. All rights reserved. LS10309 Rev F
Patents: http://embracescartherapy.com/aboutneodyne/patent-notices
ACTIVE SCAR DEFENSE
Instructions
For Use
• Skin irritation
IMPORTANT
2.4in / 6cm Applicator & Dressing
Tabs
Adhesive
Dressing
Visual
Guide
Applicator
INTENDED USE
CONTRAINDICATIONS
suspected.
following manner:
3 PRESS and HOLD the applicator on
the skin for 30 seconds. As pressure is
applied, the dressing will adhere to the
skin. No rubbing is required.
360o
Make sure the dressing is pressed
down firmly on all edges and corners.
Hold the applicator on the outside
and AVOID touching the adhesive.
4 Continue to PRESS the applicator
against the skin using the same hand.
With the other hand, PULL one tab
to the side and along the edge of the
applicator. While maintaining pressure,
repeat this step for the second tab to
release the dressing from the applicator.
2 POSITION the applicator over the scar
as shown, with the dark stripe facing
away from the body. Use the notched
area between the tabs and the visual
guide to help center the dressing over
the scar.
adhesive dressings.
it to dry.
of time.
1 OPEN by placing both thumbs in the
corner of the applicator where it is
marked OPEN, then fold the side of the
applicator with the visual guide dark
stripe all the way back.
the skin.
Applying embrace®
Maintain pressure on the applicator to
ensure the dressing remains flat as it is
detached and deployed onto the skin.
5 REMOVE the applicator from the skin.
The embrace® dressing will remain in
place over the scar. Check the dressing
to make sure it is evenly attached. Use
hands and fingers to help smooth out
any uneven areas and release any air
pockets.
APPLYING A NEW DRESSING
For scars longer than a single dressing,
complete coverage.
Before applying a new dressing, check
the scar area for skin irritation, rashes or
possible infection. Consult a health care
provider if an infection is suspected. Make
sure there is no adhesive remover left on
the skin before applying a new dressing.
See step 1 for applying a new dressing.
Begin in the middle of the scar and work
outward. Center the next embrace®
dressing over the uncovered part of the
scar. There will be an overlap of the two
dressings. Repeat these steps until the scar is
completely covered.
Troubleshooting
Helpful Hints
minimum of 8 weeks.
Removing embrace®
Dressing should completely
adhere to skin
7 DISCARD the applicator and tabs.
NOTE:
weeks.
cleansing routine, hair growth, or oil
level on the skin.
your appointment or dressing change, or
when the edges begin to lift—up to 7 days
after application.
• It is helpful to remove the dressing in the
shower using warm water and soap.
rolling it back upon itself. Use your other
hand to apply slight pressure on your skin
as you remove the dressing.
for 30-60 seconds to help it adhere
to the skin. If area is still not affixed,
remove and discard the dressing and
replace with a new one.
• If any adhesive remains, remove it with an
oil based product such as baby oil or overthe-counter adhesive remover.
• Do not apply any lotions or ointments to
the area, and keep hairs in the bikini area
trimmed.
• Allow skin to rest for 12 to 24 hours before
reapplying embrace®.
Wavy/wrinkly
appearance is OK
effective. Redoing
the application is
NOT necessary.
the next dressing.
tearing can occur.
Gently peel dressing back
at 180°
Smooth out with fingers
to release air pockets
Apply pressure and hold
to help dressing adhere to
the skin
Inc. All rights reserved. LS10305 Rev G
Instructions
For Use
ACTIVE SCAR DEFENSE
6.3
in / 16cm APPLICATOR & DRESSING
1.6in
/ 4cm Applicator & Dressing
Tabs
Visual Guide
• Skin irritation
IMPORTANT
Applicator
INTENDED USE
CONTRAINDICATIONS
suspected.
Make sure the dressing is pressed
down firmly on all edges and corners.
Hold the applicator on the outside to
AVOID touching the adhesive.
2 POSITION the applicator over the scar
as shown, with the visual guide dark
stripe facing away from the body. Use
the notched area between the tabs
and the visual guide to help center the
dressing over the scar.
4 Continue to PRESS the applicator
against the skin using the same hand.
With the other hand, PULL one tab
to the side and along the edge of the
applicator. While maintaining pressure,
repeat this step for the second tab to
release the dressing from the applicator.
adhesive dressings.
it to dry.
of time.
360o
the skin.
1 OPEN by placing both thumbs in the
corner of the applicator, then fold the
side of the applicator with the visual
guide dark stripe all the way back.
3 PRESS and HOLD the applicator on
the skin for 30 seconds. As pressure is
applied, the dressing will adhere to the
skin. No rubbing is required.
following manner:
Adhesive Dressing
Applying embrace®
Maintain pressure on the applicator to
ensure the dressing remains flat as it is
detached and deployed onto the skin.
5 REMOVE the applicator from the skin.
The embrace® dressing will remain in
place over the scar. Check the dressing
to make sure it is evenly attached. Use
hands and fingers to help smooth out
any uneven areas and release any air
pockets.
APPLYING A NEW DRESSING
For scars longer than a single dressing,
complete coverage.
Before applying a new dressing, check
the scar area for skin irritation, rashes or
possible infection. Consult a health care
provider if an infection is suspected. Make
sure there is no adhesive remover left on
the skin before applying a new dressing.
See step 1 for applying a new dressing.
Begin in the middle of the scar and work
outward. Center the next embrace®
dressing over the uncovered part of the
scar. There will be an overlap of the two
dressings. Repeat these steps until the scar is
completely covered.
Troubleshooting
Helpful Hints
minimum of 8 weeks.
Removing embrace®
Dressing should completely
adhere to skin
7 DISCARD the applicator and tabs.
8 Repeat the application process with
additional dressings as needed to
cover additional scars.
NOTE:
weeks.
cleansing routine, hair growth, or oil
level on the skin.
your appointment or dressing change, or
when the edges begin to lift—up to 7 days
after application.
• It is helpful to remove the dressing in the
rolling it back upon itself. Use your other
hand to apply slight pressure on your skin
as you remove the dressing.
for 30-60 seconds to help it adhere
to the skin. If area is still not affixed,
remove and discard the dressing and
replace with a new one.
• If any adhesive remains, remove it with an
oil based product such as baby oil or overthe-counter adhesive remover.
• Allow skin to rest for 12 to 24 hours before
reapplying embrace®.
Wavy/wrinkly
appearance is OK
effective. Redoing
the application is
NOT necessary.
the next dressing.
tearing can occur.
• Do not apply any lotions or ointments to
the area, and keep hairs in the bikini area
trimmed.
Gently peel dressing back
at 180°
Apply pressure and hold
to help dressing adhere to
the skin
Inc. All rights reserved. LS10734 Rev B
Instructions
For Use
embrace® MINIMIZE™
Featuring Stress-Shield™ Technology +
100% Medical Grade Silicone, embrace
MINIMIZE™ protects and hydrates the
scar site, helping to improve the scar’s
appearance in as little as 4 weeks.
(Individual results will vary.)
Applying embrace MINIMIZE™
CONTRAINDICATIONS
suspected.
1 Peel open packet and remove silicone
sheet. Silicone sheet has an adhesive
side covered by two protective liners.
5 Pat and roll out second half of the sheet
so it firmly adheres to the skin, covering
the entire scar site.
2 Hold the sheet with one hand and PEEL
the first protective liner off and away
from adhesive sheet. The first protective
liner is labeled “PEEL FIRST.”
MINIMIZE™ Sheet: 6.3in / 16cm
First Protective Liner
PEEL FIRST
(plastic with arrows)
Silicone Adhesive
Sheet
(under protective
liner)
Second Protective Liner
PEEL SECOND
(plastic with arrows)
INTENDED USE
embrace® is intended for use on existing
hypertrophic and keloid scars resulting
from cuts, injuries, or surgical scars. Each
sheet is designed to last an average of 10
days then discarded.
adhesive sheets.
• embrace® is water-resistant. Short term
exposure to water, (such as showering)
is OK. DO NOT expose to water for
prolonged periods of time.
adhesive sheet may strip the skin upon
Be careful not to touch the exposed
adhesive before placing over scar
3 Place exposed sheet onto scar site with
the adhesive side on the skin. Next,
press and hold sheet down to adhere to
the skin.
• Skin irritation, redness, or pain
BEFORE APPLYING embrace MINIMIZE™
motion once the sheet is applied
• Thoroughly clean and dry the scar and
surrounding area
www.embracescartherapy.com
Protective
Liner
6 Smooth out any air bubbles and apply
pressure onto entire sheet for 30-60
seconds to ensure adherence to the
skin.
Exposed sheet with
adhesive side on the skin
4 Gently peel off the second protective
liner, labeled “PEEL SECOND.”
7 Once applied, sheet can last up to 10
days, then discarded and replaced with
a new sheet.
For instructions on removing embrace,
please refer to REMOVING EMBRACE
MINIMIZE™ on the back of this insert.
Removing embrace MINIMIZE™
• It is helpful to remove the sheet in the
• Gently peel the sheet back at 180°,
rolling it back upon itself. Use your
other hand to apply slight pressure on
your skin as you remove the sheet.
tearing can occur.
• If any adhesive remains, remove it with
an oil based product such as baby oil or
over-the-counter adhesive remover.
Helpful Hints
• After initial application, embrace
MINIMIZE™ can be worn on average 10
days.
Cut-to-size embrace MINIMIZE™
The embrace MINIMIZE™ sheet may be
conveniently cut to size. Please refer to the
CUTTING TEMPLATE document included
with this IFU.
• Do not shower for 4 hours after
application.
• Moisture or condensation under the sheet
is OK (such as after showering).
appearance in the sheet is normal.
Wavy/wrinkly
appearance is OK
and sheet is still
effective. Redoing
the application is
NOT necessary.
*Example cut-template. Refer to CUTTING
TEMPLATE document before cutting.
www. embracescartherapy.com
Cut-to-size embrace MINIMIZE™
The embrace MINIMIZE™ sheet can be cut
to size for smaller scars. It is important to
read and follow the instructions below to
ensure a successful application and avoid
skin irritation:
• Align sheet over template
• Cut along the dotted lines to trim
the sheet. Sizes are indicated on the
template.
• It is important to follow the rounded
angles when cutting to ensure skin
irritation does not occur once applied.
• Do NOT cut the applicator flaps on the
protective liners located in the center
of the sheet. This area is indicated on
the template. If cut, you will not be able
to peel the protective liners from the
silicone adhesive.
To download and print additional
templates, please visit our website at:
https://www.embracescartherapy.com/
universal-uses/
www.embracescartherapy.com
*May not be to scale

Instructions For Use Applying embrace® 6.3in / 16cm Applicator

Transcription

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