® OXYGEN GENERATOR and
OxySpur® ABSORBENT FOAM DRESSING,
ADHESIVE and NON-ADHESIVE, for
ONTINUOUS DIFFUSION of OXYGEN
THERAPY
INSTRU TIONS FOR USE
For Single use
p
Keep Dry Store at Room Temperature Gamma Sterilized
PRODU T DES RIPTION
The OxyGeni System consists of the OxyGeni Oxygen Generator, Oxygen
Delivery Extension Sets, USB Charger, OxyGeni Power Pack, Carrying Case an
the OxySpur Oxygen Diffusion Dressings. Optional Humi icant Packs are
available for use in low humi ity environments.
The OxyGeni Oxygen Generator uses fuel-cell technology to continuously produce oxygen. t
is rechargeable and should be recharged daily. The pure, humidified oxygen flows out of the
O2 port through the Oxygen Delivery Extension Set to the OxySpur Oxygen Diffusion Dressing.
The OxySpur Oxygen Diffusion Dressing is a hydrophilic dressing designed for use with the
OxyGeni tissue oxygenation device in the management of wounds. The dressing is available
in two forms: OxySpur for wounds with medium to high levels of exudate, and OxySpur L TE
for wounds with low to minimal exudate.
The OxySpur dressing is a multi-layer construct with a highly absorbent hydrophilic foam layer
directly adjacent to the wounds, a highly absorbent hydrophilic foam layer with channels for
oxygen distribution, and a super absorbent polymeric laminate, all of which are covered by
an occlusive film. The adhesive version also includes a hydrocolloid adhesive border. All
versions contain an integrated oxygen delivery cannula that supplies oxygen into the oxygen
distribution foam layer. The super absorbent layer converts wound fluids into a gel,
absorbing and retaining fluid from the foam wound contact layer, thereby maintaining an
optimally balanced moisture level in the wound contacting layer for an extended period.
OxySpur L TE differs in that it has a non-adherent mesh layer directly adjacent to the wound,
one hydrophilic, yet less absorbent foam layer which is covered by an occlusive film, and an
adhesive border. OxySpur L TE is to be used on wounds with minimal to low exudate, such
as later in the healing cycle when wound exudate levels decrease.
One goal of oxygen therapy is to provide an uninterrupted and continuous supply of oxygen to
a moist wound. The dressing is designed such that the oxygen is supplied in a manner that
most closely approximates the normal diffusion of oxygen in moist tissues, yet at a rate
sufficient to fuel the increased oxygen demands required in healing tissues. This therapy is
known as Continuous Diffusion of Oxygen (CDO) therapy. The dressing helps to provide an
environment for optimal wound healing by providing CDO therapy while managing wound
exudate levels, protecting against wound dehydration and protecting against external
contamination.
OxySpur is available with or without an adhesive border. OxySpur L TE is only available with
an adhesive border. Both versions are referred to simply as OxySpur herein.
INDI ATIONS
CDO therapy is designed for patients who would benefit from wound oxygenation as it may
promote wound healing via increased collagen production, angiogenesis, reactive oxygen
species generation, and increased cell metabolism. The OxyGeni System is indicated to treat
wound types including:
• Skin ulcerations resulting from:
• diabetes
• venous stasis
• postsurgical infections
• gangrenous lesions
• Pressure ulcers
•
•
•
•
Since the dressings are able to absorb and retain fluid under pressure they
use under compression. The dressings may be used to
protection throughout the healing process.
While
The
•
Wounds with inadequate perfusion to support healing
•
Ulcers due to acute thrombophlebitis
•
Ulcers due to Raynaud’s dise
•
Necrotic wounds covered with eschar or slough
•
Wounds with fistulae or deep sinus tracts with unknown depth
PRE AUTIONS AND OBSERVATIONS
CAUT ON: Sterility of the dress
prior to use. DO NOT use if
• A
significant increase in exudate
resulting in the need for more frequent assessment and
•
The sterile dressings are intended for single use only
•
•
n case of intolerance to the dressing, remove and clean the area carefully
•
During the body’s natural healing process,
•
f the wound continues to grow larger after the first few dressing changes, consult a
•
(such as petrolatum, salves or ointments), are not applied over the wound bed below the
OxySpur dressing as this will impair performance of CDO
•
must be taken to apply the dressing such that the occlusive film is facing away from the
wound not contacting the wound surface as this will impair CDO performance
•
compression in the management of venous leg ulcers or pressure
measures in the management of pressure ulcers, systemic antibiotics and frequent
monitoring in the treatment of wound infection, control of blood glucos
for diabetic ulcers, etc.)
•
The wound should be assessed during dressing changes
•
dressing and the end of the tubing attached to the dressing are protected so
does not enter the top of the tube or the dressing
•
•
Do not cut tubing or pull on the tubing
•
•
•
tubing should be positioned uppermost (going toward the head) on intact skin and not
extend over the wound so that the risk o
potentially blocking the flow of oxygen is minimized
•
w
here possible, move the OxyGeni ou
been taken into the CT scan or x
•
patient may result in cross
•
•
increased redness, wound drainage); excessive bleeding; an unexpected change in
(allergic reaction); no signs of healing
•
• f
have additional questions a
•
•
EO
•
l
86ºF
Since the dressings are able to absorb and retain fluid under pressure they
are suitable for
use under compression. The dressings may be used to
provide moisture management and
protection throughout the healing process.
can be used on highly exuding wounds, the level of exudate will determine the
of the dressing, and the wound should be monitored accordingly.
System is contraindicated for the following:
Wounds with inadequate perfusion to support healing
Ulcers due to acute thrombophlebitis
Ulcers due to Raynaud’s dise
ase
Necrotic wounds covered with eschar or slough
Wounds with fistulae or deep sinus tracts with unknown depth
PRE AUTIONS AND OBSERVATIONS
CAUT ON: Sterility of the dress
ing is guaranteed unless the pouch is damaged or opened
prior to use. DO NOT use if
either has occurred.
significant increase in exudate
may occur during the early phase of CDO therapy,
resulting in the need for more frequent assessment and
dressing changes. To reduce the
sing changes, you may add absorptive dressings under the OxySpur
The sterile dressings are intended for single use only
ation date
n case of intolerance to the dressing, remove and clean the area carefully
During the body’s natural healing process,
edema may decrease and non-viable tissue
removed from the wound (autolytic debridement), which could initially make the
f the wound continues to grow larger after the first few dressing changes, consult a
important that occlusive materials, such as film dressings or oil-based products
(such as petrolatum, salves or ointments), are not applied over the wound bed below the
OxySpur dressing as this will impair performance of CDO
OxySpur dressing has an occlusive film on one side (the side with bubbles) and care
must be taken to apply the dressing such that the occlusive film is facing away from the
wound not contacting the wound surface as this will impair CDO performance
supportive measures should be taken where necessary (e.g. use of
compression in the management of venous leg ulcers or pressure
redistribution
measures in the management of pressure ulcers, systemic antibiotics and frequent
monitoring in the treatment of wound infection, control of blood glucos
e and offloading
for diabetic ulcers, etc.)
The wound should be assessed during dressing changes
showering the OxyGeni should be disconnected from the dressing: ensure the
dressing and the end of the tubing attached to the dressing are protected so
that water
does not enter the top of the tube or the dressing
not take the OxyGeni apart
Do not cut tubing or pull on the tubing
Y splitter to the tubing since this may impair CDO performance
OxyGeni can be charged using any other USB charger than that supplied with the
ensure that the dressing is positioned centrally over the wound: the dressing
tubing should be positioned uppermost (going toward the head) on intact skin and not
extend over the wound so that the risk o
f fluid collecting around the tubing and
potentially blocking the flow of oxygen is minimized
and x-ray have the potential to interfere with some electronic medical devices:
here possible, move the OxyGeni ou
t of the x-ray or scanner range: if the OxyGeni has
been taken into the CT scan or x
-ray range, check that it is functioning correctly following
OxyGeni is single patient use only: use of any part of this system on more than one
patient may result in cross
-contamination that may lead to infection
temperatures and humidity may reduce wear times of dressings
a healthcare professional if there are: signs of infection (increased pain,
increased redness, wound drainage); excessive bleeding; an unexpected change in
nd color and/or odor; irritation (increased redness and/or inflammation); sensitivity
(allergic reaction); no signs of healing
instructions are not intended to supersede the instructions of your health care
have additional questions a
bout your OxyGeni System please call your local wound care
have immediate medically related questions or concerns, please call your physician
serious incident that has occurred in relation to the OxyGeni System to
Concepts and the authority having jurisdiction in your locale.
(USA) restricts this device to sale or rental by or on the order of a physician
System set up
•
Be sure to have these items available to comp
o
OxyGeni
Oxygen Generator and Wound Monitoring Device
o
OxyGeni
Oxygen Delivery Extension Set (
o
OxySpur Dressing (size of dressing is determined by your
•
Optional items:
o
OxyGeni
o
OxyGeni
o
OxyGeni
o
Skin prep
o
o
Fixative film
o
APPLYING THE OxySpur DRESSING
Prior to application:
•
C
•
Debride wound of
devitalized tissue (eschar, slough, etc. may interfere with oxygen
delivery)
•
Select a dressing that will allow the wound contact area to completely
and extend onto healthy tissue
•
Use Skin protection before applying an adhesive dressing
NOTE: Do not
typically water based and work well with CDO.
Applying
NOTE:
non-
adhesive dressing instead.
•
Hydrocolloid
your hands prior to application. Remove part of the clear liner to expose the adhesive
(hydrocolloid) portion of the dressing
•
when the patient removes the OxyGeni to shower or bathe
•
Position and smooth into place
clear plastic liner
•
Carefully smooth
adhesive film border and the periwound skin
•
(hydrocolloids activate with heat an
NOTE: The adhesive
the next dressing change.
changes, unless instructed to do so by a clinical caregiver.
needed when removing the dressing.
Applying Non-
Adhesive OxySpur Dressings:
NOTE:
Use of a skin protectant should be used before placing the dressing to protect the
peri-
•
Orientate the
dressing such that the tu
when the patient removes the OxyGeni to shower or bathe
•
Place
the dressing over the wound.
(The side with the
•
A
OxySpur dressing to secure the dressing in place
•
f required, the dressing can be cut,
•
For
highly exuding wounds, be sure to secure any fixative over all of the edges of the
dressing
NOTE:
into the dressing and can be achieved using a wrap or a sock.
use with compression, from light compression stockings up to 4 layer compression wraps
NOTE: The seal around the dressing edges does not have to be perfect, yet gaps or tears
could allow exudate to damage the periwound and potentially lower o
being produced than consumed by the wound, the oxygen pressure will build in a tightly
confined space).
•
instructed to by clinical caregiver.
could allow
excessive exudate to damage the periwound
concentration at the wound site, which could affect the efficacy of the therapy
OxySpur ANNULA ORIENTATION & PLA EMENT
For
instructional videos, visit our
YouTube.com.
Be sure to have these items available to comp
lete your system set up:
Oxygen Generator and Wound Monitoring Device
Oxygen Delivery Extension Set (
connecting tubing)
OxySpur Dressing (size of dressing is determined by your
clinical caregiver)
hydrophilic fill materials
APPLYING THE OxySpur DRESSING
area.
devitalized tissue (eschar, slough, etc. may interfere with oxygen
Select a dressing that will allow the wound contact area to completely
cover the wound
and extend onto healthy tissue
Use Skin protection before applying an adhesive dressing
oil based products such as petrolatum, salves or ointments: they do not
enetrate and will impair the efficacy of CDO therapy. Gels and creams are
typically water based and work well with CDO.
ssings:
in protectant should be used before placing the adhesive dressing. f you
t the patient’s skin will not tolerate a strong adhesive, we advise using the
adhesive dressing instead.
e efficiently when warm. Warm the adhesive portion with
your hands prior to application. Remove part of the clear liner to expose the adhesive
(hydrocolloid) portion of the dressing
such that the tubing exiting the dressing is on top/up when the
ding or resting. This will help to prevent exudate from entering the tubing
when the patient removes the OxyGeni to shower or bathe
Position and smooth into place
(bubble-side up) while removing the second half of the
around the edge of the dressing to ensure good contact between the
adhesive film border and the periwound skin
to the adhesive until it becomes firmly attached to the skin
(hydrocolloids activate with heat an
d pressure)
are designed to be strong enough to stay on the patient until
the next dressing change.
Advise patients against lifting or removing the dressing between
changes, unless instructed to do so by a clinical caregiver.
An adhesive remover may be
needed when removing the dressing.
Adhesive OxySpur Dressings:
Use of a skin protectant should be used before placing the dressing to protect the
dressing such that the tu
bing exiting the dressing is on top/up when the
ding or resting. This will help to prevent exudate from entering the tubing
when the patient removes the OxyGeni to shower or bathe
the dressing over the wound.
Ensure the foam side is face down against the wound
ubble print should be facing out)
lm dressing, tape, wrap or conforming bandage should be applied over the
OxySpur dressing to secure the dressing in place
f required, the dressing can be cut,
although note that this may increase the risk of
highly exuding wounds, be sure to secure any fixative over all of the edges of the
ure should be placed on the entire dressing to ensure that the dressing
ce of the wound. This enables wicking of excess fluid from the wound bed
into the dressing and can be achieved using a wrap or a sock.
All dressings are suitable for
use with compression, from light compression stockings up to 4 layer compression wraps
.
NOTE: The seal around the dressing edges does not have to be perfect, yet gaps or tears
could allow exudate to damage the periwound and potentially lower o
xygen concentration at
o tight of a seal may cause a blockage alarm over time (if more oxygen is
being produced than consumed by the wound, the oxygen pressure will build in a tightly
vised against lifting or removing the dressing between changes, unless
instructed to by clinical caregiver.
Ensure that the edges are firmly sealed. Gaps or tears
excessive exudate to damage the periwound
and potentially lower the oxygen
concentration at the wound site, which could affect the efficacy of the therapy
OxySpur ANNULA ORIENTATION & PLA EMENT
instructional videos, visit our
YouTube channel: search "EO2 Concepts” on
