NPWT Renasys and Pico Clinical Guidelines

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Negative
Pressure Wound
Therapy Clinical
Guidelines
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NPWT customer care details

Smith & Nephew Customer Care Center Advice/Service details Consult your local Smith &
Nephew representative if you
USA 24/7 NPWT Clinical Support have any questions about
970 Lake Carillon Drive 1 800-876-1261 operation or use. Information
Suite 110 on RENASYS™ or PICO™ devices
St. Petersburg, FL 33716 can be found in the user device
manual or on the web at
Canada www.myrenasys.com or
2280 Argentia Road www.possiblewithpico.com
Mississauga Ontario
L5N 6H8
These guidelines are recommendations to help clinicians to establish condition-specific treatment

guidelines when using NPWT as part of the treatment protocol. Please consult the patient’s primary
physician or clinician about individual conditions and treatment. These guidelines are not intended
as a guarantee of results, outcome or performance of NPWT.

Introduction
1 Indications for use
Contraindications
Warnings
Precautions
General therapy considerations

2 Wound assessment
Choosing a wound filler/wound interface
Considerations for pump selection
RENASYS™ portfolio – pumps and canisters
Dressing change
Tips and trick frequencydressing wear time
for improving
NPWT pressure settings
RENASYS Soft Port – considerations for use
Physician orders
How do I know if the RENASYS therapy device is working?
RENASYS-G Gauze Dressing Kit with Soft Port

3 Kit sizes and components
Application technique
RENASYS-F Foam Dressing Kits with Soft Port

4 Kit sizes and components
5 RENASYS High Output Dressing Kit

Kit components
RENASYS AB Abdominal Kit with Soft Port

6 Kit components
Indications
Contraindications
Warnings
Precautions
Advanced-complex dressing techniques

7 Bridging – managing multiple wounds
Y-Connector – managing multiple wounds
Undermining and/or tunnelling
Skin grafts (Split and full-thickness)/skin substitutes
Circumferential extremity dressing
RENASYS accessories
8 RENASYS Adhesive Gel Patch
RENASYS Drain Accessory Kits
PICO™ Single Use Negative Pressure Wound Therapy System

9 Description
Indications for use
Contraindications
Warnings
Precautions
Dressing change
Guidance on wound suitability for management with PICO
Instructions for use
10 Clinical Hotline
Appendix
11 Appendix I – Negative Pressure Product Portfolio – Products and Accessories
Appendix II – Instructions for Use – RENASYS Foam and Gauze Dressing Kits with Soft Port
Appendix III – Instructions for Use – RENASYS AB Abdominal Dressing Kit with Soft Port
Appendix IV – Instructions for Use – RENASYS High Output Dressing Kit
Appendix V – Instructions for Use – RENASYS Drain Accessory Kit
Appendix VI – Instructions for Use – PICO Single Use Negative Pressure Wound Therapy System
Appendix VII – Frequently asked questions and answers
Appendix VIII – References

1. Introduction
Section 1
Negative pressure Wound Therapy (NPWT) is an

established therapy that has changed the way serious
wounds are treated. Smith & Nephew has been
involved in wound care since 1856. As global provider
of wound care solutions, Smith & Nephew is known
for providing innovative enhancements and greater
options for NPWT use, and for placing the option for
NPWT use within a broader continuum of care.
Smith & Nephew has an extensive portfolio in wound
care and therapies that cover all of its major aspects.
The concept is well established that wounds are
managed across a continuum of healing and require
different therapies at each step in the continuum.
NPWT is no exception. Smith & Nephew offers NPWT
as part of a complete range of wound care products
to use along the patients’ journey towards healing.
The key
stage of to
thedeciding which
continuum product
is to identifytothe
usebarriers
at eachto
healing and a treatment goal to combat those issues.
The treatment goal can be a variety of steps along the
wound healing continuum such as to control infection or generate a healthy granulating wound bed. Different
products are appropriate to address different treatment goals and the correct product choice is necessary not
only to achieve positive outcomes, but to also provide efficient use of resources.
When NPWT was initially introduced it was reserved for use on the most complex wounds. Today, however,
NPWT is widely adopted as a standard treatment for patients with both acute and chronic wounds. A variety
of formats are now available, and, as the wound progresses along the continuum, a switch from one format
to another may be the most appropriate course. NPWT has been shown to be cost effective when used
appropriately. However, it is important to guard against over-use of NPWT in order to maintain these health
economic benefits.isKnowledge
more appropriate of when
vitally important NPWT is an
to maintain most appropriate
efficient and when while
use of resources alternative therapies
not effecting may be
wound
outcomes negatively.
Negative Pressure Wound Therapy (NPWT) involves the application of controlled levels of sub-atmospheric
(negative) pressure to a wound. The systems described in these guidelines consist of a suction pump to
generate negative pressure and a variety of wound dressing kits to deliver the therapy to the wound site.
The benefits of NPWT go well beyond drainage management. Studies have shown NPWT improves granulation
tissue formation, may decrease bacterial burden, protects from the outside environment, promotes moisture
balance within the wound bed, and may decrease the frequency of dressing changes.1
The following Clinical Guidelines are meant to be used as recommendations for treating specific wound types.
The Guidelines cannot guarantee positive outcomes, wound healing or proper function of the Smith & Nephew
NPWT device.
condition As with anytreatment.
and prescribed medical device,
Alwaysconsult
consultthe
andphysician/clinician concerning
follow all applicable the patient's
user manuals, productindividual
inserts,
instructions for use, safety information and references guides for product use, operation and application.
The purpose of this document is to describe the most appropriate use of NPWT as an integral part of wound
bed preparation to ensure optimal healing and cost-effective wound care.
6

Wound bed preparation

Wound bed preparation has been defined as the process of 1. Prepare the wound environment
removing the barriers to healing. Removal of these barriers is
thought to allow the wound repair process to progress normally.
Wound bed preparation represents a combination of both scientific 2. Use NPWT
knowledge and practical skill; its application can help correct
abnormalities in acute and chronic wounds and stimulate or 3. Know when to stop or change treatme
progress the healing process.2 To optimize the use of NPWT, it is
essential that clinicians ensure wound bed preparation is achieved
prior to, during and after therapy. Optimal healing/cost-effective wound car
Tissue nonviable Infection Moisture Epidermal margin/

or deficient or inflammation imbalance extracellular matrix
T I M E
Negative pressure wound therapy (NPWT)
NPWT)
Antibacterial
dressing Foam
Hydrosurgery
Skin care system Skin care
Foam Ag
Collagen
Cadexomer iodine matrix
1. Debride wound 2. Optimize healing 3. Know when to stop or change

Effective debridement may: • Remove excess fluid edema treatment
• Reveal extent of tissue • Assist in wound contraction • Initial therapy objectives have
damage • Stimulate granulation tissue been met
• Reduce biochemical • Protect from outside • 100% granulation tissue in the
imbalance, senescent cells contaminants wound bed
• Reduce bacterial burden • Increase vascular perfusion • Granulation tissue level with
• Reduce odor the surrounding skin
• May reduce wound bioburden
• Optimize healing potential • Patient’s overall condition/
• Remodel connective tissue
wound is improving
matrix • Wound bed ready to take a
Consequences of ineffective • Encourage maturation of
skin graft/flap
debridement are: epithelial cells
• Exudate levels less than
• Delayed healing • Maintain a moist wound
20–50mLs per day
• Potential for infection healing environment
• No improvement/reduction in
• Physical barrier preventing size is seen in the wound bed
accurate assessment following two consecutive
• Reduced patient Quality of dressing changes
Life (QoL)
• Psychological aspects
Negative Pressure Wound Therapy Clinical Guidelines


Section 1
RENASYS™ EZ Plus/RENASYS GO
RENASYS-F Foam Dressing Kits with Soft Port
RENASYS-G Gauze Dressing Kits with Soft Port
Indications for use

The RENASYS system is indicated for patients who would benefit from a suction device
(negative pressure wound therapy) as it may promote wound healing by removing fluids,
including irrigation and body fluids, wound exudates and infectious materials.
Examples of appropriate wound types include:

Chronic
Acute
Traumatic
Sub-acute and dehisced wounds
Ulcers (such as pressure or diabetic)
Flaps and grafts
Partial-thickness burns
Contraindications
The use of the RENASYS system is contraindicated in the presence of:
Necrotic tissue with eschar
Untreated osteomyelitis
Malignancy in wound (with exception of palliative care to enhance quality of life)
Exposed arteries, veins, organs or nerves
Non-enteric, unexplored fistulas
Anastomotic sites
8

Warnings
Note: Full device operation instructions are found in the User Guide for each RENASYS device
1. Patients must be monitored closely for bleeding. If sudden or increased bleeding is observed,
immediately discontinue therapy, take appropriate measures to stop bleeding and contact the
treating clinician.
2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an
increased risk for bleeding. During therapy, avoid using hemostatic products that, if disrupted, may
increase the risk of bleeding
3. Sharp edges or bone fragments in a wound must be covered or removed prior to using the RENASYS
system due to risk of puncturing organs or blood vessels while under negative pressure.
4. Do not use the RENASYS device directly on exposed blood vessels, organs or nerves.
5. In the event defibrillation

defibrillation. Remove theiswound
required, disconnect
dressing the device
if the location willfrom the wound
interfere dressing prior to
with defibrillation.
6. The RENASYS device is not MRI or CT compatible. Disconnect the pump from the patient and do not
bring the device into the MRI suite or scanner range.
7. When operating, transporting, repairing or disposing of RENASYS device and its accessories, the
risk of infectious liquids being aspirated or contamination of the device cannot be eliminated.
Universal precautions should be observed whenever working with potentially contaminated parts or
equipment.
8. RENASYS devices have not been studied on pediatric patients. Patient size and weight should be
considered when prescribing this device.
9. RENASYS devices are not suitable for use in areas where there is danger of explosion (e.g. hyperbaric
oxygen unit).
Special precautions for Hyperbaric Oxygen Chambers (HBO): oil-emulsion and Petrolatum based
dressings are not recommended for use on patients undergoing HBO therapy and should be
removed prior to therapy and/or a consideration of use under the NPWT dressing on patients
undergoing HBO therapy.
10. The RENASYS devices (pumps) and the RENASYS canister kits are provided non-sterile and should
not be used in a sterile field.


Section 1
Precautions
Note: Full device operation instructions are found in the User Guide for each RENASYS device
1. Precautions should be taken for patients who are or maybe:
• Receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have weakened
blood vessels or organs.
• Suffering from difficult wound hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
2. Infected wounds may require more frequent dressing changes. Regular monitoring of the wound must be
maintained
3. Therapy to check
should remainforON
signs
for of
theinfection.
duration of the treatment. There may be situations when the patient
needs to be disconnected from the NPWT device, for example, for activities of daily living and diagnostic
testing. If the patient needs to be disconnected, the suction tubing should be disconnected and the ends
of the tubing capped. How long patients may be disconnected from the NPWT device is a clinical decision
based on individual characteristics of the patient and the wound. Factors to be considered would include
amount of drainage, location of the wound, integrity of the dressing seal, assessment of bacterial burden
in the wound and patient’s risk of infection. The RENASYS devices have an Intermittent Mode with a 5
minute ON/2 minute OFF cycle appropriate for wound care usage as prescribed by the treating clinician.
5. This device should only be used by qualified and authorized personnel. The user must have the
necessary knowledge of the specific medical application for which the RENASYS system is being used.
6. If the device has been at temperatures below freezing, bring the device to room temperature prior to use
or the unit may be damaged.
7. Ensure that tubing is installed completely, connected correctly and without any kinks to avoid leaks or
blockages in the vacuum circuit.
8. Position the device and tubing appropriately to avoid the risk of causing a trip hazard and of the patient
lying on the tubing. Where possible, the device system tubing should be positioned horizontal with or
below the wound.
9. When bathing/showering, the patient must be disconnected from the device.
10. If any liquids penetrate the device, discontinue use and return to your authorized provider for service.
11. Do not apply NO-STING SKIN-PREP™ directly onto open wounds.
12. Maintain regular monitoring of the RENASYS device and the wound site during therapy to ensure
therapeutic treatment
reports discomfort withand
thepatient
vacuum comfort. The vacuum
level, consider level the
reducing should never be painful. If the patient
pressure.
13. Underlying structures, such as bone and tendon, must be covered by the non-adherent dressing layer.
14. A RENASYS device is only to be used with Smith & Nephew authorized components.
15. Ensure the dressing clamp is engaged prior to switching off the device. For reconnection to the device,
ensure that the device is active prior to opening the dressing clamp.
10

Additional device (pump) specific precautions:

RENASYS™ GO carry bag contains magnets which may influence the function of certain
electrical devices, including pacemakers.
RENASYS EZ Plus:
1. Contains an in-line overflow protection/bacteria guard. Inspect the Bacterial Overflow Guard
on the canister and replace the canister as necessary. At minimum, the canister should be
changed weekly.
2. Should only be used with Smith & Nephew 250mL S- (Sealed) and 800mL S-Canister Kits.
3. The device should only be used in the upright position.


2. General therapy considerations

Section 2
Wound assessment
Success of the NPWT treatment depends heavily upon the quality of the clinical wound
assessment. The wound should have a detailed assessment at the initiation of the NPWT
treatment regime and with every dressing change thereafter. The following areas should be
addressed with every wound assessment:
Wound size: length, width, depth
• NPWT has the ability to assist with removal of interstitial fluid and sloughy necrosis. With the
removal of the space filling materials, the volume of the wound may increase slightly. This will
likely happen within the first few dressing changes, especially if the wound is in the inflammatory
phase of wound healing.
Granulation tissue: amount and description
• Healthy granulation tissue should be beefy red and not bleed easily. No trauma should occur to
the granulation tissue with dressing removal. A Non-Adherent dressing or a contact layer may be
used.
Epithelialization: amount and description
• Epithelialization should be “silvery” in appearance. The new cells are very fragile. If undermining is
present, it is important to fill the undermined areas with gauze or foam to prevent the edges from
rolling under.
Necrotic tissue: type and amount
• NPWT, along with the autolytic environment established by the Transparent Film, may result in a
decrease in necrotic slough.
• Presence of eschar is a contraindication. Eschar should be debrided before NPWT is initiated.
Exudate: type, amount and consistency
• Assess wound
consistent exudate forwith
characteristics type,
theamount,
wound color and the
type and consistency. Evaluate
anticipated theSignificant
exudate. wound exudate for
changes
in exudate warrant a re-assessment of the wound.
Odor: present/absent, description
• It is important to note that body fluids that have been contained in a sealed system for an
extended period of time will likely have an unpleasant odor. This odor is not a direct indication of
wound infection. Remove the soiled dressing from the wound and discard per facility protocol.
Clean wound per protocol, and then, if an odor persists, an assessment for presence of an
infection may be necessary.
Pain: use facility approved tool for rating pain
• There should not be pain with the RENASYS™-G Gauze Dressing Kit. If the patient experiences
pain, decrease the amount of pressure. The pressure range is 40-120mmHg which should allow
for pressure adjustment to ensure pain-free NPWT therapy.
• When using the RENASYS-F Foam Dressing Kit, tissue adherence may be reduced by use of a
contact layer, decreasing the pressure, and/or increasing the frequency of the dressing changes.
12

Choosing a NPWT wound filler/wound interface

Factors to consider include:
• Wound size and volume
• Contour of wound bed
• Amount and type of exudate
• Patient comfort and preference
• Characteristics of granulation tissue
• Caregiver skills
Wound size considerations:

• Small to moderate size wounds with shallow to deep depth: both foam and gauze may be used
with similar ease of application
• Moderate to large surface area wounds with shallow depth: gauze is generally considered easier
to apply
• Moderate to large surface area wounds with deep depth: foam may be considered easier to use
Wound bed contour considerations:

• Distribution of pressure requires intimate contact with entire wound surface.
- Smooth wound bed contour
- Irregular contour – undermining or tunneling
• Ease of application.
- Surface area
- Wound depth
- Anatomical location
Wound bed contour 3
Wound bed with irregular Gauze wound filler easily Foam wound filler may not
contour maintains contact with intimately contact irregular
irregular surface shape spaces in wound bed


Section 2
The choice of wound filler will be influenced by the amount and

consistency of wound exudate
Wound exudate level

Low High
Gauze
Foam
Note: In wounds
generally with large amounts of exudate a wound interface (non-adherent layer) is
not recommended.
If using gauze with larger amounts of exudate, the drain should be placed close to the
wound bed over a single layer of gauze.
Patient comfort4
• The RENASYS™-G Gauze Dressing Kit should be changed 48 hours after initiating therapy to assess
the patient’s response to the therapy. If the patient is comfortable and the wound is responding
positively to the therapy, the subsequent dressing change frequency is 2-3 times per week.
• Pain is a very subjective experience and will vary with each patient. Research has validated that
patients report less pain with gauze.
Pain/discomfort
Lower level Higher level
Gauze Foam
Granulation tissue
• NPWT with foam wound filler has historically been used to prepare wounds for grafting. More
recently gauze has been used by plastic surgeons and feedback suggests that the granulation
tissue is smoother, less inflamed and an excellent bed for receiving a STSG. 5
Skin grafts
• NPWT with gauze has been found to give excellent results on irregular and mobile surfaces. 6
14

Gauze/foam combination therapy:

RENASYS™-G Gauze Dressing and RENASYS-F Foam Dressing can be used in combination in a
wound being treated with negative pressure wound therapy. While combination therapy may
be of benefit for optimizing the best wound healing environment for the patient, this option is
dependent on the individual wound characteristics and clinical judgment.
It is appropriate to use a combination foam/gauze therapy where the HCP determines the
necessity for this combination therapy. Examples may include wounds that have explored tunnels,
undermining or sinus tracts with an open central area. The moistened gauze can be placed in
these areas with foam placed on top ensuring the foam is in contact with the gauze. Another type
of wound that may be appropriate for combination therapy is a circumferential wound where the
gauze is wrapped around an extremity in combination with the foam placed in areas to assist in
managing removal of exudate.

NPWT and combination therapy for infected wounds:
If the wound is infected, consider using one of the Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 are both compatible with either
RENASYS systems or PICO Single Use Negative Pressure Wound Therapy System. ACTICOAT 3
or ACTICOAT 7 may also be used with the RENASYS systems if the dressings are fenestrated
for application.


Section 2
Considerations for pump selection

Both the RENASYS™ EZ Plus and RENASYS Go devices can be used on a variety of wounds.
Optimally the RENASYS EZ Plus is Optimally the RENASYS GO is

recommended for: recommended for:
• Moderate to large volume wounds • Small to medium volume wounds
• Difficult to seal locations • Low to moderate exudate levels
• High exudate levels • Home care setting
• Large surface area wounds • Ambulatory patients
• Open abdominal wounds
• Acute setting/hospitalized, limited
ambulatory patients
16

RENASYS™ portfolio – pumps and canisters

These NPWT Clinical Guidelines are for use with the RENASYS and PICO™ systems. The systems do not have
the same features or require the same guidelines. Refer to specific quick reference guides, Instructions for
Use (IFU) or specific product user manuals for additional instructions. There may be certain unique indications,
contraindications, precautions and warnings for each individual product.
RENASYS EZ Plus RENASYS GO

Component list Component list
• Pump • Pump
• Canister holder kit • Power cord
• Power cord • Quick reference guide
• Quick reference guide • Strap
800mL S-Canister RENASYS GO Large

Component list; 10 kits per case Canister (750mL)
• Sealed canister Component list; 5 per case
• With or without solidifier • Sealed canister
• Overflow guard with silicone tubing • Solidifier
• Canister tubing • Canister tubing
250mL S-Canister RENASYS GO

Component list; 10 kits per case
• Sealed canister
Canister
Component (300mL)
list; 5 per case
• Solidifier • Sealed canister
• Overflow guard with silicone tubing • Solidifier
• Canister tubing • Overflow guard with silicone t
• Canister tubing


Section 2
Dressing change frequency

The RENASYS™-G Gauze and/or RENASYS-F Foam Dressing Kits should be changed 48 hours after
initiating therapy to assess the patient's response to the therapy. If the patient is comfortable and
the wound is responding positively to the therapy, the subsequent dressing change frequency is
2-3 times per week or 48 to 72 hours.
Check dressings at regular intervals.
Infected wounds may require more frequent dressing changes. Monitor the wound to assess for
changes in signs or symptoms of infection.
Throughout treatment, monitor for any signs of local or systemic infection. If there are any signs
of systemic infection or advancing infection at the wound site, contact the treating physician/
clinician immediately.
Tips and tricks for improving dressing wear time

To enhance dressing wear time, use these basic wound care tips:
• SKIN-PREP™ should be routinely used to protect the periwound area. If skin in the periwound area
is damaged or fragile, a hydrocolloid or adhesive film may be used to protect the area prior to
applying the cover Transparent Film.
• Apply SKIN-PREP barrier to edges of Transparent Film to prevent rolling.
• Apply Ostomy Strip Paste and/or the RENASYS Adhesive Gel Patch to skin irregularities such as
abdominal skin folds or cleft at sacrococcygeal juncture. This will help to decrease depth of the
skin irregularity.
• Border Transparent Film with Waterproof Tape.
NPWT pressure settings

General guidelines:
• Recommended pressure range for the RENASYS NPWT systems is 40mmHg to 120mmHg.
• Generally a pressure level of 80mmHg is used with gauze and 120mmHg with foam. If a patient
experiences discomfort, it may help to reduce the pressure level. A lower pressure range between
40mmHg-80mmHg provides less painful NPWT while handling most exudate levels, types, and
consistencies.
• An increase in the pressure may be necessary according to size of wound, viscosity of exudate,
amount of exudate and clinical judgment of desired wound outcomes.
• Anatomical location and tissue pliability may also influence pressure level utilized.
18

Recommended pressure settings

Wound type Suggested Pressure setting Wound contact Special considerations
filler layer
Acute/traumatic Gauze or -80 to -120mmHg If tendon, bone, Infected wounds and fragile structures should b
foam and/or other fragile protected and care taken to avoid desiccation of
structures are tendon if exposed
exposed
Partial thickness abdominal Foam -80 to -120mmHg Not required unless Layer the filler into the wound to ensure it fits the
(muscle intact) adhesion occurs cavity from the bottom up to ensure contact with
wound margins
Full thickness Decompression Abdominal -60 to -120mmHg OPL large enough The lead clinician must take full responsibility for
abdominal & closure dressing to cover all fragile treatment choices and materials/method of NPW
(muscle with OPL structures should be and pressure setting used
intact) used
Healing by Gauze -60 to -120mmHg Essential to protect Use a single layer of wound contact layer to ens
secondary exposed fragile any fragile structures are protected and to ensur
intention structures is removed and replaced at each dressing chang
Extra care should be taken when patients have
inflammatory bowel disorders/infected/inflamed
bowel. Lead clinician must be consulted prior to
commencement of therapy
Pressure ulcers Gauze -60 to -80mmHg Yes if tendon/bone Always address underlying aetiology and factors
exposed affecting healing – if slough or necrosis present
debride prior to commencement of NPWT or
consider using foam
Diabetic foot ulcers post surgery Gauze -60 to -80mmHg Yes if tendon/bone Dressing should be placed as soon after surger
exposed is practical once hemostasis is achieved
Diabetic foot ulcers Gauze or -60 to -80mmHg Yes if tendon/bone Sharp debridement of any devitalized tissue sho
foam exposed occur prior to placement of NPWT
Meshed
tissue grafts/bioengineered Gauze -50 to -80mmHg Yes to avoidof filler to
adherence Dressings areinstructions
per clinician typically removed after 5 days or a
the graft
Flaps Gauze -50 to -80mmHg Yes to avoid Dressings are typically removed after 5 days or a
adherence of filler to per clinician instructions
the graft
Dehisced surgical wounds Foam -80 to -120mmHg Yes if tendon, bone, Consideration should be taken to debride any
and/or other fragile devitalized tissue prior to commencement of NP
structures are
exposed
Chronic wounds Gauze -80mmHg Yes if tendon/bone Always address underlying etiology and factors
exposed affecting healing
Enteric fistula (explored) Gauze or -80mmHg Yes to protect See RENASYS™ High Output Dressing Kit applica
foam exposed fragile technique, page 32
structures


Section 2
RENASYS™ Soft Port – considerations for use

• Each RENASYS Dressing Kit with Soft Port contains 1 Soft Port.
• Each Soft Port is surrounded by 4.5 inch x 5.5 inch (11.4cm x 14cm) of polyurethane film.
• The Soft
of the Port film extends
Transparent from the
Film covering thesuction
wound.opening to ensure an effective seal of the Soft Port to the top
• It is important to align the opening of the Soft Port with the opening in the Transparent Film to ensure a
good seal and decrease the risk for a false blockage alarm.
• The Soft Port opening is .25 inches (0.6cm) in diameter. It is important that the opening in the wound
Transparent Film be .25 inches (0.6cm) in diameter as well.
• When making the opening in the wound Transparent Film, remove any loose edges from the film to prevent
aspiration into the Soft Port, possibly causing a false blockage alarm.
• Single Soft Ports are available to assist when Y-Connecting multiple wounds and/or other applications.
• Single Soft Ports are sold separately in the RENASYS Port Kit – individually wrapped and sterile.
• All Soft Port dressings can be left in place up to 72 hours
The Soft Port is encased in a white covering

1. Patient dignity – exudate in the Soft Port channel is more discreet with the opaque white covering
2. The white coloring reflects any color changes occurring within the fluid – most prominently, blood and
color changes that may be associated with presence of bacteria. For example:
Bright red coloration Blue/green coloration

The visual appearance of a bright red color • The visual appearance of a blue/green color
within the RENASYS Soft Port may signal within the RENASYS Soft Port supports a
a more critical concern, as this is normally conclusion that Pseudomonas species has
associated with high concentrations of colonized the wound.
whole blood. • The color is from
Pseudomonas a pigment
species calledcreated by the
pyocyanin.
Important customer reminders:
• If blood is visible in the Soft Port before the • A characteristic smell may also be noted
blockage alarm activates, clinicians should when this type of effect is noted.
stop therapy immediately and take the • You may also see gauze dressings similarly
relevant corrective actions. colored in this way.
• The RENASYS Soft Port IFU states
haemostasis should always be achieved
prior to initiating NPWT.
20

Physician orders
Prior to placement of the RENASYS™ device, the medical professional treating the wound
must assess how best to use the system for an individual wound. It is important to carefully
assess the wound and the patient to ensure clinical indications for NPWT are met.
All Rx orders should include:
• Wound location, size, and type
• Smith & Nephew wound dressing kit type
• Vacuum settings (recommended ( -40mmHg to -120mmHg)
• Frequency of dressing changes
• Adjunctive dressings

How do I know if the RENASYS therapy device is
working?
While the RENASYS GO therapy device is turned on a green light will illuminate. The
illuminated light located at the top of the device tells you the device is on and vacuum is
working. If the device is set to CONTINUOUS mode (recommended) the selected pressure is
displayed on the screen. If the device is set to INTERMITTENT mode, the gauge will show 0
pressure during “off time” and the set pressure while vacuum is occurring.
While RENASYS EZ Plus is turned on you will hear the device running and the set pressure
will show on the gauge.
It is important to monitor the activity of the device while you are using the therapy.
Does the dressing have a raisin-like appearance?
Gauze with drain Gauze with Soft Port Foam with Soft Port


3. RENASYS™-G
Section 3 Gauze Dressing Kit with Soft Port

Kit sizes and components
The RENASYS-G Gauze Dressing Kit is part of the Smith & Nephew RENASYS NPWT system. The RENASYS-G
Gauze Dressing Kit contains everything you need to perform the dressing change with the exception of gloves and
scissors. The RENASYS-G Gauze Dressing Kit is designed to provide the clinician with many options to address
most wound types, locations, and exudate levels. The table below will help guide you to the appropriate Kit size for
your patients' wounds.
Kit Contents Small Medium Large X-Large Sterile with Soft Port
Saline 30ml Bullet 1 bullet, 30mL 1 bullet, 30mL 1 bullet, 30mL 2 bullets, 30mL –
Wound Ruler 1 wound ruler 1 wound ruler 1 wound ruler 1 wound ruler –
NO-STING SKIN-PREP™ 1 sachet 1 sachet 1 sachet 2 sachets –
Soft Port 1 – Length 27in (69cm) 1 – Length 27in (69cm) 1 – Length 27in 1 – Length 27in (69cm) 1 – Length 27in (69cm)
Applicator head Applicator head (69cm) Applicator head Applicator head
6in x 4in 6in x 4in Applicator head 6in x 4in 6in x 4in
(15cm x 10cm) (15cm x 10cm) 6in x 4in (15cm x 10cm) (15cm x 10cm)
(15cm x 10cm)
AMD Gauze Dressing 1 dressing – 2 dressings – 1 roll – 2 rolls – 1 dressing –
6in x 6.7in 6in x 6.7in 4.5in x 4.1yd 4.5in x 4.1yd 6in x 6.7in
(15cm X 17cm) (15cm X 17cm) (11cm x 4m) (11cm x 4m) (15cm x 17cm)
1 roll –
4.5in x 4.1yd
(11cm x 4m)
Transparent Film 1 – 8in x 12in 1 – 8in x 12in 2 – 8in x 12in 3 – 8in x 12in 3 – 8in x 12in
(20cm x 30cm) (20cm x 30cm) (20cm x 30cm) (20cm x 30cm) (20cm x 30cm)
Non-Adherent Gauze 1 – 3in x 8in 1 – 3in x 8in 2 – 3in x 8in 4 – 3in x 8in –
(8cm x 30cm) (8cm x 30cm) (8cm x 30cm) (8cm x 30cm)
22

Antimicrobial Gauze (included in RENASYS™-G

Gauze Dressing Kits and separately in RENASYS
Accessory Kits)
• The primary purpose of the gauze is to fill the wound space.
• When contracted under suction it serves two functions:
- it equally distributes negative pressure across the wound bed
- provides a pathway or conduit for wound fluid to exit the wound
• The gauze is impregnated with 0.2% polyhexamethylene biguanide or
PHMB. This antimicrobial agent is present to inhibit the proliferation of
bacteria in the dressing.
• It is important to always moisten the gauze prior to placement in the
wound bed.
• Moistening the gauze also ensures that the entire wound surface is in
contact with the gauze.
• The Antimicrobial Gauze has been studied to sustain its antimicrobial
effectiveness for 72 hours.
• If wound is exposed to fecal matter, urine, or other undesirable
elements, it is suggested that the dressing be removed, wound
cleaned per protocol, and a new dressing applied.
• The 72 hour efficacy of the Antimicrobial Gauze does not dictate the
dressing change frequency. The frequency of the dressing change
should be determined by a thorough assessment of the wound
including exudate levels.
• If the system is applied correctly and the seal is maintained, the
gauze will not dry out due to the occlusive nature of the sealed
dressing system.
Note: The Antimicrobial Gauze is not indicated to be moistened
with any solution except saline, tap water, or sterile water.


Section 3
Non-Adherent Gauze
• A Non-Adherent Gauze on the wound bed maybe used to reduce the
risk of pain and bleeding during dressing changes.
• This gauze is an oil-emulsion dressing that protects fragile tissue at
the time of the dressing change.
• It is recommended that a Non-Adherent Gauze be placed over any
exposed bone, tendon, or fragile structures as well as any part of the
wound bed that may need protection.
• It is recommended that a Non-Adherent layer or contact layer
be placed under the foam and/or gauze interface over meshed
grafts and some bioengineered tissues (as recommended by the
manufacturer).
• Cut a single layer to the size and shape of the wound bed.
• Non-Adherent Gauze is meant to be used as a contact layer.

• The Non-Adherent Gauze is air and exudate permeable.
Special precautions for Hyperbaric Oxygen Chambers (HBO): Oil-
emulsion and petrolatum based dressings are not recommended
for use on patients undergoing HBO therapy and should be
removed prior to therapy and/or a consideration of use under the
NPWT dressing on patients undergoing HBO therapy. The pump
should be disconnected and NPWT discontinued during HBO
therapy.
Note: It is recommended not to use the Non-Adherent Gauze
under ACTICOAT™
Flex 7 as 3, ACTICOAT
the oil-emulsion 7, ACTICOAT
dressing Flex 3,with
may interfere or ACTICOAT
the
effectiveness of the silver and antimicrobial effectiveness of the
ACTICOAT dressings.
24

Transparent Film
• The Transparent Film is a gas permeable membrane
designed to create a seal.
• It creates a barrier to outside contaminants.

• It needs to cover the entire wound and at least 2
inches (5.1cm) of the intact periwound skin.
• It can also be used for patching if a leak situation
occurs.
• Note: In highly exuding wounds, adding
SKIN-PREP™ to the periwound skin will reduce
the risk of maceration.
• The Transparent Film may be cut into strips for easier
application.
Saline (0.9% Sodium Chloride)

30ml Bullet
A Saline bullet may be provided in the RENASYS™-G
Gauze Dressing Kit and can be used to moisten
the Antimicrobial Gauze prior to placing in the
wound bed.
NO-STING SKIN-PREP™ Barrier Pad

• NO-STING SKIN-PREP is used to protect the
patient’s skin upon dressing removal and to assist
with the adherence of the Transparent Film.
• Do not apply directly on to open wound.
Tips for increasing the dressing longevity:

• SKIN-PREP ™/NO-STING SKIN-PREP should routinely be used to protect the periwound area. If skin in the
periwound area is damaged or fragile, a hydrocolloid or adhesive film may be used to protect the area prior to
applying the cover Transparent Film.
• Apply SKIN-PREP barrier to edges of Transparent Film to prevent rolling.
• Apply RENASYS Adhesive Gel Patch to skin irregularities such as abdominal skin folds or cleft at
sacrococcygeal juncture. This will help to reduce depth of skin irregularity.
• Border Transparent Film with Waterproof Tape.


Section 3
RENASYS™-G Gauze Dressing with Soft Port application technique

Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits approved
for use with the RENASYS System.
Clean and debride

Debride any devitalized or necrotic eschar tissue. Cleanse the wound and pat dry as per
local protocol.
If desired, protect the periwound skin from exposure to moisture and adhesive through the
use of a skin sealant.
If desired, a non-adherent wound contact layer may be applied. Trim a single layer of
Non-Adherent Gauze to fit the wound dimensions and lay across the wound bed.
If the wound is infected, consider using one of Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 may be used in conjunction
with RENASYS NPWT treatments. ACTICOAT 3 or ACTICOAT 7 may also be used if the
dressings are fenestrated for application.
Dress the wound with gauze

Apply a layer of saline-moistened antimicrobial gauze to wound bed.
Continue to apply in layers until the gauze loosely fills the entire wound cavity.
Avoid over packing the wound.
If multiple pieces of gauze are used to fill the wound, count and record how many pieces
are present to ensure all pieces are removed at a dressing change.
26

Seal the wound

Remove panel #1 of the Transparent Film, exposing the adhesive. Apply over the wound
and remove the remaining panel #2 to seal. Once placed, remove the top panel #3.
Continue to apply until the gauze is completely covered and the wound is sealed.
Apply the Soft Port

Cut a small hole (no less than 2.0cm) in the center of the film, over the gauze. Remove any
loose Transparent Film and dispose.
Remove the adhesive backing panel from the Soft Port dressing and align directly over
the hole in the Transparent Film. Use gentle pressure to anchor it to the Transparent Film.
Smooth the dressing down while removing the Soft Port stabilization frame.
Secure the Soft Port to the patient according to your institutional protocol. Ensure
the aeration disc, located near the Quick-Click Connector, is not covered or
otherwise occluded by the method used to secure the Soft Port.
Aeration
disc
Connect thetogether.
Connectors Soft Por t An
tubing to the
audible canister
click tubing
indicates theby pushing on
connection the Quick-Click
is secure.
Activate the RENASYS™ device and adjust the prescribed therapy level. Finished
dressings should be firm to the touch.


4. RENASYS™-F
Section 4 Foam Dressing Kit with Soft Port
Kit sizes and components

The RENASYS Soft Port simplifies and enhances negative pressure wound therapy by reducing the need for
bridging which saves time and materials. The Soft Port reduces the risk of pressure-related injuries and eases
patient discomfort by replacing the hard tubing with a soft, cushioned channel, while maintaining the ability to
operate at peak performance when compressed, twisted or kinked by a patient or surrounding object. RENASYS-F
Foam Dressing Kit is sterile, rendering it perfect for use in all care settings, from OR to home care.
Kit contents* Small Medium Large X-Large Soft Port Stand-

Alone Kit
Soft Port 1 – Length 27in (69cm) 1 – Length 27in (69cm) 1 – Length 27in (69cm) 1 – Length 27in (69cm) Length 27in (69cm)
Applicator head Applicator head Applicator head Applicator head Applicator head
6in x 4in 6in x 4in 6in x 4in 6in x 4in 6in x 4in
(15cm x 10cm) (15cm x 10cm) (15cm x 10cm) (15cm x 10cm) (15cm x 10cm)
Foam block 1 – 4in x 3in x 1in 1 – 8in x 5in x 1in 1 – 10in x 6in x 1in 1 – 20in x 25in x 0.6in –
(10cm x 8cm x 3cm) (20cm x 13cm x 3cm) (25cm x 15cm x 3cm) (50cm x 63cm x 1.5cm)
Transparent
Film 1 – 8in x 30cm)
(20cm 12in 2 – 8in xx 30cm)
(20cm 12in 3 – 8in xx 30cm)
(20cm 12in 6 – 8inxx30cm)
(20cm 12in –
*5 kits per case
28

RENASYS™-F Foam Dressing
• Reticulated open pore hydrophobic polyurethane foam.

• Cut foam to size and shape of the wound.
• Foam should fill the wound cavity. Do not force or pack foam into any areas of the wound.
• It may be necessary to stack pieces of foam in deeper wounds.
• A contact layer may be used under the foam if adherence or pain is a concern. Example of contact
layers are Non-Adherent Gauze, ACTICOAT™ 3, ACTICOAT 7, ACTICOAT Flex 3, or ACTICOAT Flex 7.
It is suggested to fenestrate the ACTICOAT 3 or ACTICOAT 7 on more heavily exuding wounds.
• Rub the edges of the foam after cutting to remove any loose fragments.
• Do not cut foam directly over wound bed to avoid foam fragments from falling into the wound bed.
• It is recommended to document the number of foam pieces placed in the wound to ensure all are
removed at dressing change.
• Do not place foam into blind or unexplored tunnels.
• If foam dressing adheres to wound bed:
1. Power down device.
2. Apply normal saline into the wound dressing and let set for 15-30 minutes.
3. Gently remove dressing.

4. Dispose of dressing in accordance with local guidelines.
• Tissue adherence may be reduced by use of a contact layer, decreasing the pressure and/or
increasing the frequency of the dressing changes.


Section 4
RENASYS™ Transparent Film
• Stronger, proprietary adhesion formulation developed by Smith & Nephew provides superior adhesion to skin in
a wide variety of skin moisture conditions, yet is safe and gentle for regular use and removal. It has a long, proven
history of superior performance to many other types of acrylic adhesives available in the market, decreasing the
chance of undesired film removal from the skin.
• Thicker film minimizes the risk of undesired tearing of the film and increases the ease of handling during
application.
• More breathability allows for greater skin moisture vapor permeability without negatively affecting the seal
strength. May help decrease risk of periwound skin maceration.
• More extensible film contours more easily to challenging anatomical geometries. Extends more easily with the
skin to reduce leakage.
• The Transparent Film is a gas permeable membrane designed to create a seal.
• With proper use, it allows appropriate moisture balance within the dressing/wound which is essential to healing.
• It creates a barrier to outside contaminants.
• It needs to cover the entire wound and at least 2 inches (5.1cm) of the intact periwound skin.
• It can also be used for patching if a leak situation occurs.
• The Transparent Film may be cut into strips for easier application.
RENASYS Transparent Film is sold separately.

RENASYS Transparent Film RENASYS Transparent Film X-Large
Component list; 10 kits per case Component list; 10 kits per case
10 – Transparent Films per kit 5 – Transparent Films per kit
8in x 12in (20cm x 30cm) 16in x 25in (40cm x 60cm)
30

RENASYS™-F Foam Dressing with Soft Port application technique

Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits approved
for use with the RENASYS System.
Clean and debride

Debride any devitalized or necrotic eschar tissue. Cleanse the wound and pat dry as per
local protocol.
If desired, protect the periwound skin from exposure to moisture and adhesive through the
use of a skin sealant.
If desired, a non-adherent wound contact layer may be applied. Trim a single layer of
Non-Adherent Gauze to fit the wound dimensions and lay across the wound bed.
If the wound is infected, consider using one of Smith & Nephew’s ACTICOAT™ products to
address the infection. ACTICOAT Flex 3 and ACTICOAT Flex 7 may be used in conjunction
with RENASYS NPWT treatments. ACTICOAT 3 or ACTICOAT 7 may also be used if the
dressings are fenestrated for application.
Dress the wound with foam

Cut foam dressing to fit the size and shape of the wound. Foam should completely fill the
wound.
Do not cut the foam directly over the wound bed and after cutting brush the sides to
dislodge small fragments of foam.
Place the cut foam into the wound. Avoid over packing. Do not force foam into the wound
or place within an unexplored tunnel. It may be necessary to stack pieces of foam in
deep wounds.
If multiple pieces of foam are used to fill the wound, count and record how many pieces
are present to ensure all pieces are removed at a dressing change.


Section 4
Seal the wound

Remove panel #1 of the Transparent Film, exposing the adhesive. Apply over the wound
and remove the remaining panel #2 to seal. Once placed, remove the top panel #3.
Continue to apply until the foam is completely covered and the wound is sealed.
Apply the Soft Port

Cut a small hole (no less than 2.0cm) in the center of the film, over the foam. Remove any
loose Transparent Film and dispose.
Remove the adhesive backing panel from the Soft Port dressing and align directly over
the hole in the Transparent Film. Use gentle pressure to anchor it to the Transparent Film.
Smooth the dressing down while removing the Soft Port stabilization frame.
Secure the Soft Port to the patient according to your institutional protocol. Ensure
the aeration disc, located near the Quick-Click Connector, is not covered or
otherwise occluded by the method used to secure the Soft Port.
Aeration
disc
Connect thetogether.
Connectors Soft Port An
tubing to the
audible canister
click tubing
indicates theby pushing on
connection the Quick-Click
is secure.
Activate the RENASYS™ device and adjust the prescribed therapy level. Finished
dressings should be firm to the touch.
32

5. RENASYS™ High Output Dressing Kit
Kit components
The RENASYS High Output Dressing Kit from Smith & Nephew, in conjunction with the
RENASYS EZ Plus pump, is an intuitive, cost-effective, and clinically proven NPWT solution
for managing explored enterocutaneous fistulas and other high output type wounds.
2 – 30mL saline bullets
4 – strips waterproof tape
1 – strip paste
1 – wound ruler
2 – sachets of NO-STING SKIN-PREP™
1 – 28 Fr round aspiration/irrigation drain 3ft (92cm)
2 – Non-Adherent Gauze 3in x 8in (8cm x 20cm)
2 – AMD gauze rolls 4.5in x 4.1yd (11cm x 4m)
3 – RENASYS Transparent Films 8in x 12in (20cm x 30cm)
The RENASYS High Output Kit should be used with the RENASYS EZ Plus device.
NOTE: The High Output Dressing Kit is not compatible with the RENASYS GO Device.
Irrigation/Aspiration Lumen
• This is a round, perforated, 28 French, double lumen, 7 foot long drain.
• Irrigation port for irrigating the wounds or decreasing the viscosity of the exudate.
• Double lumen allows for irrigation and instilling medication per clinician discretion.
Irrigation/ 28 French round

aspiration lumen large bore


Section 5
RENASYS™ High Output Dressing Kit application technique

High output/thin consistency dressing procedure
• Cover wound bed, including fistula opening, with Non-Adherent Gauze or with one layer of saline
moistened AMD gauze.
• Place drain in close proximity to fistula opening and in dependent/inferior position.
• Fill remaining wound deficit with additional saline moistened AMD gauze.
• Cover with Transparent Film.
• Secure drain with Waterproof Tape using Chevron Technique.
• Apply Negative Pressure at 40-120mmHg.

• Dressing change frequency may be greater than 3 times per week.
• If output is high, e.g. 800cc per shift or greater, the dressing integrity may only last up to 24 hours.
• This improves patient comfort by reducing dressing change frequency and is also more cost effective
than traditional, non-NPWT methods of addressing a fistula.
Sediment laden output considerations

• Sediment may not flow through the gauze layer.
• May require NPWT dressing and an ostomy pouch/wound management pouch device.
Sediment laden dressing procedure

• Cover entire wound bed, excluding fistula opening, with one layer of Non-Adherent Gauze OR saline
moistened AMD gauze.
• Place Irrigation/Aspiration drain in close proximity to fistula opening and in dependent/inferior
position.
• Fistula opening is exposed.
• Fill wound deficit with additional saline moistened AMD gauze, continue to leave fistula opening
exposed.
• Cover entire wound with Transparent Film.

• Create opening in Transparent Film over fistula opening.
• An ostomy pouch may be placed over fistula opening/hole in the Transparent Film and secured.
• Apply negative pressure at 40-120mmHg.
Note: Non-enteric, unexplored fistulae are contraindicated for NPWT.
34

Drain position
• Always position drain inferior or “dependent” of fistula opening to
assist with fluid removal.
• Place drain openings in close proximity to fistula opening to quickly
remove fluid as it is produced.
Fistula precautions
• Never place drain into fistula opening.
• Never lay drain on top of fistula opening.
• Patient’s fluid levels should be closely monitored, particularly with
infants, children, and geriatrics.
Fistula location and fluid description

• The higher the fistula occurs in the bowel...the thinner, more caustic
and heavier the output.
• The lower the fistula occurs in the bowel...the thicker or pastier the
output.
Higher output fistula considerations

• Large volumes of thin fluids.
• Must be able to pass through gauze.
Note: Non-enteric, unexplored fistulae are contraindicated

for NPWT.


Section 5
Types of fistulas
Drain recommendation: Irrigation/Aspiration Drain
(contained in the RENASYS™ High Output Dressing Kit)
• Fistulas can be internal or external:

- Internal – communication is between a body cavity or hollow organ to another body cavity
or hollow organ.
- External – communication between a hollow organ and the skin.
• Fistula terminology – Described by the anatomic location or the site of origin and the site of
termination.
Name From To Type
Enterocutaneous Intestine Skin External
Recto-vaginal Rectum Vagina Internal
Vesicocutaneous Bladder Skin External
• Fistulas may also be described by amount of output:

- High output – 500cc or more/24 hours
- Moderate output – 200-500cc/24 hours
- Low output – less than 200cc/24 hours
• The wound surrounding the fistula opening should respond as any other wound on NPWT
by displaying decreased size, decreased drainage, and increase in granulation tissue.
The fistula opening will likely require surgical intervention or pouching depending on the
maturation of the fistula.
• Smith & Nephew recommends the gauze based interface when addressing high output
fistulas.
Note: Patient's PO intake should be considered. Patient's fluid levels should be closely
monitored, particularly with infants, children and geriatrics.
Note: Non-enteric, unexplored fistulae are contraindicated for NPWT.
36

6. RENASYS™ AB Abdominal Kit with Soft Port
Kit components
RENASYS AB Abdominal Dressing Kit is designed for use with the RENASYS EZ Plus device as a
complete negative pressure wound therapy for managing open abdominal wounds.
The RENASYS AB Dressing Kit includes the following components:
Organ Protection Layer (OPL) x 1 Pre-shaped Foam x 2
Transparent Adhesive Film x 6 RENASYS Soft Port Dressing x 1

1 – Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm)
2 – foam blocks 17in x 12in x 1in (43cm x 30cm x 3cm)
6 – RENASYS Transparent Films 8in x 12in (20cm x 30cm)
1 – Organ Protection Layer 35in x 26in (89cm x 66cm)


Section 6
RENASYS™ AB Abdominal Kit with Soft Port

Indications
The RENASYS
EZ Plus deviceAB
andAbdominal Dressing
canisters as Kit with
a complete NPWTSoftsystem
Port is for
intended for use
managing in abdominal
open conjunctionwounds.
with the RENASYS
• RENASYS AB is indicated for temporary bridging of abdominal wall openings where primary closure is not
possible and/or repeat abdominal entries are necessary.
• It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to
abdominal compartment syndrome.
• RENASYS AB is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and
should ideally be applied in the operating room.

Contraindications
The use of RENASYS AB is contraindicated:
• For non-enteric, unexplored fistulae
• For untreated osteomyelitis
• For malignancy in the wound (with the exception of palliative care to enhance quality of life)
• When vital organs and structures are not covered with the Organ Protection Layer (OPL)
• For the presence of necrotic tissue with eschar
• For use in patients with on-going or high potential for hemorrhage and/or enteric leak
Warnings
• Hemostasis must be achieved prior to dressing application. Carefully monitor patients undergoing treatment
with RENASYS AB for signs of sudden or increased bleeding. If such symptoms are observed, immediately
discontinue therapy, take appropriate measures to control the bleeding, and contact the treating clinician.
Precautions should be taken for patients who are, or may be:
- Receiving anticoagulant therapy or platelet aggregation inhibitors
- Actively bleeding or have friable blood vessels or organs
- Suffering from abnormal wound hemostasis
- Untreated for malnutrition

- Noncompliant or combative
- Suffering from wounds in close proximity to blood vessels or friable fascia
• Sharp edges such as bone fragments must be covered or removed prior to initiating therapy, due to risk of
puncturing organs or blood vessels drawn closer under the action of negative pressure.
• Foam must not be tightly packed or forced into any wound area. Foam must only be placed in the wound defect
once the OPL has been placed.
38

• In the event defibrillation is required, disconnect the device from the wound dressing only if its location will interfere
with defibrillation.
• RENASYS™ EZ Plus is not MRI compatible. Do not bring device into MRI suite.
• When operating, or
being aspirated, transporting, repairing
contamination of the or disposing
device of RENASYS
assembly throughdevices
incorrectand accessories,
use, the risk of infectious
cannot be eliminated. Universal liquids
precautions should be observed whenever working with potentially contaminated parts or equipment.
• RENASYS EZ Plus and RENASYS AB have not been studied on pediatric patients. Patient size and weight should be
taken into account when prescribing this device.
• RENASYS devices are unsuitable for use in areas where there is a danger of explosion (e.g. hyperbaric oxygen unit, or in
the presence of a flammable anesthetic mixture with air or nitrous oxide). Disconnect the device from the dressing prior
to entering an area where this equipment will be used.
• RENASYS devices and canister kits are provided non-sterile and should not be used in a sterile field.
Precautions
Note: Full device operation instructions are found in the user guide for RENASYS EZ Plus.
• While using RENASYS AB, therapy should remain on in the CONTINUOUS mode for the duration of the treatment. If the
patient must be disconnected from the device, protect the tube ends by inserting the tethered caps of the Quick-Click
Connector immediately before turning off the device.
• CT scans and X-ray have the potential to interfere with some electronic medical devices. When possible, move the
device out of the X-ray or scanner range, check that it is functioning correctly following the procedure.
• Whenever possible, the device and system tubing should be positioned level with or below the wound.
• The length of time a patient may be disconnected from the RENASYS EZ Plus device is a clinical decision based on
individual characteristics
the dressing of the of
seal, assessment patient andburden
bacterial the wound.
in theFactors
wound,toand
consider include
patient’s theinfection.
risk of volume of drainage, integrity of
• As a condition of use, RENASYS AB with the RENASYS system must only be applied and operated by qualified and
authorized personnel. The user must have the necessary knowledge of the specific medical application for which
RENASYS AB in indicated.
• During therapy, maintain regular monitoring of the device and tubing, from wound site to canister, to ensure therapeutic
benefit and patient comfort.
• Position the device and tubing appropriately to avoid the risks of causing a trip hazard and of the patient lying on the
tubing.
• Check the Bacterial Overflow Guard on the canister and replace the canister as necessary. Minimally, a weekly canister
change is recommended. Always use the smallest practical canister size, based on the patient’s size and weight to
avoid risk of significant and or unintended fluid and blood loss.
• The lowest recommended therapy pressure for using RENASYS AB with the RENASYS EZ Plus device is 80mmHg.
• If any liquids penetrate the pump, discontinue use and return to your authorized provider for service.
• While using RENASYS AB, apply Universal Precautions according to your institution’s protocols, to minimize the risk of
contact with any blood-borne pathogens. Measures may include use of sterile gowns and eye protection with severely
contaminated wounds.


Section 6
Precautions specific to RENASYS™ AB

Note: Ensure aseptic technique is used during the application of all components of RENASYS AB.
Ensure the abdomen and its contents are adequately visualized, controlled and protected throughout
application of dressing.
• Medical intervention with RENASYS AB should only be undertaken as part of a holistic medical management
strategy, with the goal of reducing the patient’s intra-abdominal pressure to normal levels. Factors to consider
should include the etiology of the patient’s intra-abdominal hypertension (IAH) or Abdominal Compartment
Syndrome (ACS), as well as other factors (including the patient’s size, weight and unique clinical situation).
• Frequent, standardized measurements of the intra-abdominal pressure (IAP) and/or abdominal perfusion
pressure (APP) are recommended before, during and after treatment with RENASYS AB, as a means of guiding
clinical decisions concerning management of the open abdomen.
• RENASYS AB is not intended to provide primary treatment for infection in the open abdomen. RENASYS AB
may, however, be used on septic open abdomens, which are being managed in accordance with institutional
clinical protocols for infection abatement, as an adjunct to the standard treatment regimen, and/or to provide a
barrier to bacterial penetration.
• Use of the Organ Protection Layer is necessary to protect exposed bowel from the abdominal wall. Preventing
adhesions or obstructions that may otherwise form during open abdominal wound management is a critical
parameter in achieving timely primary fascial closure and reducing the chance of fistula formation. The OPL
must completely cover all exposed viscera, prior to application of wound filler and subsequent activation of the
NPWT system.
• Use caution when utilizing RENASYS AB with patients suffering from intestinal obstruction in the small or large
bowel, which may include (but is not limited to) hernias, adhesions from previous abdominal surgery or from
underlying pathologies such as Chrohn’s Disease or Irritable Bowel Syndrome (IBS). Obstructions may often
be complicated by dehydration and/or loss of electrolytes – this is especially the case if the patient has bowel
exposed.
• Patients with circulatory

require careful or intestinal
consideration anastomoses
while using RENASYS (including, butwith
AB. Patients notenteric
limited fistula
to arterial
havegrafts or gastricrisk
an increased bypass)
of
abdominal contamination if output is not carefully managed during the course of treatment with RENASYS AB.
• During the course of treatment, the RENASYS AB dressing and RENASYS NPWT system will remove third space
fluid in the abdominal compartment. Large volumes of fluid can be collected during the course of treatment.
The volume and appearance of the fluid in both the canister and tubing should be checked and recorded
frequently while the patient receiving therapy. The canister should be replaced prior to reaching full-capacity.
Viscous exudates increase the risk of blockage in the system, monitor closely.
• The fluid level in the canister may be used as an approximate guide when considering the necessity of fluid
resuscitation. Planning for fluid replacement should be a clinical consideration in all patients undergoing
therapy with RENASYS AB.
• Planning
RENASYSfor
AB.fluid replacement should be a clinical consideration in all patients undergoing therapy with
• Protection of the periwound skin area from moisture and adhesive irritation may be accomplished through the
use of a skin sealant. Because of the risk of further damage to the periwound area, foam should never overlap
onto intact skin without first protecting the skin with additional Transparent Film or a hydrocolloid dressing.
40

RENASYS™ AB Abdominal Kit with Soft Port application technique

Use clean or sterile/aseptic techniques protocol. Only use RENASYS Dressing Kits
approved for use with the RENASYS System.
Open abdominal wound preparation

Warning: Review all RENASYS NPWT system safety information before beginning
wound preparation. Ensure adequate hemostasis has been achieved prior to
dressing placement.
1. Sharp edges or bone fragments must be eliminated from wound area or covered
2. Ensure any areas of necrosis are appropriately debrided
3. Irrigate abdominal wound as needed
4. Clean and dry the periwound area
Organ Protection Layer (OPL) application

Warning: Protect
at all times duringvital structures
therapy. Foam such as never
should bowelbe
and abdominal
placed organs
in contact with
with the OPL
exposed
bowel, arteries, veins, organs or nerves. The OPL is designed to allow application
directly over exposed internal organs and can be cut or folded as desired. Either side
of the OPL may be placed against the viscera.
Remove contents from pouch and prepare the OPL on a sterile field. If cutting the OPL to a
different size, ensure that each piece removed has been properly disposed of, away from
the open wound.
Ensure gloves are wet before applying the OPL. Gently position the OPL evenly into the
abdominal cavity, distributing the sides into both of the lateral paracolic gutters. Any
excess material on the sides of the OPL may be folded back onto itself.
Ensure complete coverage of all viscera in the abdominal compartment with the OPL prior
to filling the wound defect with foam.


Section 6
Pre-shaped Foam application

Size the foam to the desired proportions by tearing along the pre-scored perforations. The
foam should fit directly over the OPL while maintaining contact with the wound margins.
Foam may be cut if required. Do not cut the foam directly over the wound bed. Always rub
the edges of any cut foam to remove loose fragments.
Do not allow foam to contact intact skin without use of an appropriate barrier such as
Transparent Film or a hydrocolloid. It may be necessary to stack multiple pieces of foam
depending on the wound profile. If multiple pieces of foam are required, count and record
how many pieces are used to ensure all pieces are removed upon bandage changes.
Gently place the perforated foam into the wound cavity over the OPL. Ensure the foam
is sized to fit
abdominal loosely in the wound defect and does not go below the level of the
wall.
Transparent Film application

Holding the Transparent Film, expose one side of the adhesive backing by removing a
single panel and apply it to the foam.
Apply film to the foam removing adhesive panels as well as the carrier film to seal.
Cover the foam with Transparent Film. The film should extend at least 5cm beyond the
wound margin to facilitate a good seal.
When using multiple pieces of film ensure the edges overlap by a minimum of 7.5cm. Avoid
stretching or pulling the film to minimize tension or trauma to the periwound skin.
42

RENASYS™ Soft Port application

Cut a hole no smaller than 2cm in the center of the film. Remove any excess trimmed film
and dispose of away from the wound.
Remove the adhesive panel from the Soft Port dressing and align the port opening over the
hole in the Transparent Film. Use gentle pressure to anchor the Soft Port dressing to the
Transparent Film.
Smooth the dressing down while removing the stabilization frame from the Soft
Port dressing.
Initiation of therapy
Ensure the canister is installed correctly and connect the in-line Bacterial Overflow Guard
to the device. To prevent airflow into the device ensure the guard tubing is fully inserted
past the 4th ridge into the device vacuum port. Connect the Soft Port to the canister tubing
by pushing the Quick-Click Connectors together.
Activate the RENASYS EZ Plus device on continuous mode. Set the pressure to 80mmHg to
commence and check the dressing has a good seal.
The finished dressing should collapse and be firm to the touch. If required, adjust the
pressure setting to desired level. The recommended pressure range for temporary
abdominal closure is 80-120mmHg.


7. Advanced-complex
Section 7 dressing techniques
Bridging – managing multiple wounds

with the RENASYS™-G Gauze Dressing
Kit or the RENASYS™-F Dressing Kit
Transparent Film
and the Soft Port Dressing
Bridging Technique – this technique is used to

join two wounds that are close in proximity and/ Transparent Film
or to position the Soft Port in an area away from
the wound.
• Apply non-adherent layer to both wounds to cover
fragile tissue and/or as a non-adherent if using
gauze as the filler.
• Protect intact skin in area under bridge and between
the wounds with Transparent Film.
• Cut additional
Transparent foam
Film or gauze
to form and place on top of
the bridge.
• Maximum distance between wounds for bridging is
10 inches (25.4cm). If the distance is greater than 10
inches a Y-Connector should be considered.
• Important: Contact must be made between the
bridge foam/gauze and the foam/gauze filler in
the wound bed (overlap).
• Complete NPWT dressing application technique
for the RENASYS-F Foam or RENASYS-G Gauze
dressings – covering both the wound and bridge
with Transparent Film.
• Initiate negative pressure. Cut hole in Transparent Film 0.25in.
(0.6cm) in diameter and place the
Soft Port dressing
44

Y-Connector – managing multiple wounds

Y-Connectors are available to connect multiple wounds to a single unit.
• Compatible with RENASYS™-F Foam Dressing and RENASYS-G Gauze Dressing Kits.
• Compatible with RENASYS GO and RENASYS EZ Plus devices.
Y-Connector instruction
• Connect canister tubing to selected RENASYS Canister (if applicable). RENASYS GO
canister tubing is pre-assembled.
• Attach Y-Connector tubing to canister tubing via Quick Click Connector.
• After completing the wound dressings, attach each dressing tubing to the “Y” arms of the
Y-Connector using the Quick Click Connectors.
• Pressure level recommendations are the same as when addressing one wound:
40-120mmHg.
• Do not cut tubings.
• Y-Connectors are sold separately.
• It is recommended to change the Y-Connector a minimum of one time per week. Or, as a
rule, change the Y-Connector with the canister change.
Dressing integrity must be maintained at each dressing site.
• It is not recommended to connect an infected wound (pressure ulcer) to a non-infected
wound (closed incision or graft site) via the Y-Connector.
• Do not connect wounds requiring different pressure settings.
Y-Connector vs. bridging

• Y-Connect when the distance between the two wounds is greater than 10 inches or
25.4cm.
• Bridging should be possible when the distance between the two wounds is less than 10
inches or 25.4cm.
Tips for success

• When utilizing two Soft Ports with Y-Connector, blockages are not detected unless
both Soft Ports are blocked.
• If both wounds must be monitored, consider a bridging technique using a single Soft
Port instead of a Y-Connector
• When treating separate wounds the clinician should regularly check the wound being
treated with the drain or Soft Port to ensure the dressing is compressed
• When utilizing Y-Connector with the Soft Port, consider utilizing RENASYS EZ Plus
pump.


Section 7
Undermining and/or tunneling

Undermining
Undermining is a lateral tissue defect or pocket under the edges of the wound. The surface opening is
smaller than the base of the wound.
Ways to address undermined wounds:
• Utilizing saline moistened gauze, fill the undermined areas and any dead space of the wound.
• Once the undermined areas have been filled with moistened AMD gauze, gauze or foam may be used to fill
the remainder of the wound making sure that all areas of the wound are in contact with wound filler.
• Cover with Transparent Film as normal.
Tunneling or sinus tracts

A tunnel or sinus tract is a narrow opening in the wound bed that extends into adjacent tissue.
Ways to address tunnels or sinus tracts

Option 1 –
• Fill tunnels or sinus tract with moistened AMD Gauze, sterile packing strips, or ACTICOAT™ Flex; pulling out/
back 0.5 to 1cm to allow for healing distal to proximal.
• Make sure the tunnel filler material is visible in the wound bed to assure removal upon dressing change.
• Continue with RENASYS™ dressing application technique utilizing AMD Gauze or Foam assuring that all areas of
the wound are in contact with the wound filler.
Option 2 –
• Use channel drain, please see drain accessory.
• Measure tunnel by inserting the channel drain to base of tunnel.

• Pull back on the drain be 0.5-1cm to prevent pressure and allow for healing at distal end of tunnel.
• The portion of the drain in the tunnel/sinus tract is left unwrapped and free of wound filler material.
• Wrap the remainder of the train with saline moistened AMD gauze assuring that the drain hub or drain
junction is in the middle of the wound and at least one layer of moistened AMD gauze is between the drain
and wound bed.
• Fill any dead space or remainder of the wound with additional saline moistened AMD gauze or foam filler.
• Cover with Transparent Film as normal and follow drain accessory kit dressing application.
46

Tips for success

• It is important to note the exudate level of the wound.
• Make sure the drain chosen adequately manages the wound's exudate level.
- The Flat drain handles minimal to heavy drainage.
- The Channel Drain handles scant to moderate drainage, no thick drainage, no
sediment.
• The portion of the drain that goes into the tunnel does not have to be wrapped
with saline moistened gauze.
• It is not necessary to wrap the portion of the drain contained to the wound bed as
long as there is at least one layer of gauze between the drain and the wound bed.
• Make sure the level of the gauze is slightly higher than skin level to ensure the dead
space is filled once the suction collapses the gauze.
• Ensure all dead space is filled with saline moistened gauze and/or packing strips.


Section 7
Skin grafts (Split and full-thickness)/skin substitutes

Treatment goal
• Bolster the graft in place to prevent sheering and ultimate loss of the
graft.
• Eliminate excess moisture that could lead to the graft lifting, preventing
graft take.
Suggested pressure setting and dressing change frequency

• Pressure setting recommendation is 40-120mmHg.
• Ultimately, the pressure setting is a decision to be determined by the
physician/clinician. Generally, lower pressure setting are utilized
(60-80mmHg) for skin grafts and over skin substitutes.
NOTE: It is recommended that you follow the manufacturer’s
guidelines for NPWT use over skin substitutes.
• Initial dressing change at 3-5 days post application depending on
physician/clinician preferences.
• Exudate level should decrease after the first 24-48 hours.
• Duration of therapy is also a physician/clinician decision (generally 3-10
days).
• It is required that NPWT therapy remains on continuously to ensure the
graft remains bolstered at all times.
RENASYS™-F Foam Dressing with Soft Port or RENASYS-G Gauze

Dressing with Soft Port
• Cover the entire graft with a non-adherent layer, such as ACTICOAT™ Flex
3 or ACTICOAT Flex 7. ACTICOAT 3 or ACTICOAT 7 may also be used if
the dressings are fenestrated for application.
• Extend the contact layer at least 1 inch (2.54cm) past the suture/staple
line.
• Cut foam or gauze to the size and shape of the contact layer.
• Place cut foam or gauze on top of the contact layer.
• Cover foam or gauze with Transparent Film and apply Soft Port per
dressing application technique in the instructions for use.
48

Circumferential extremity dressing

Application guide to lower limb wound with RENASYS™ Soft Port
Measure the Transparent Film and trim to size if required.
Expose one side of the adhesive backing by removing panel #1.
Gently position the Transparent Film under the patient’s limb.
Wrap the Transparent Film around the limb and remove panel #2 to seal.
Smooth the Transparent Film dressing down.
Remove the top stabilization panel #3 from either the side or the central split.


Section 7
Wrap the opposing Transparent Film around the limb. Remove adhesive panel #2
to seal.
Smooth the Transparent Film dressing down around the limb.
Remove the other top stabilization panel #3 from either the side or central split.
If required use additional Transparent Film to ensure the dressing edges are
adequately sealed.
Apply RENASYS™ Soft Port in desired location avoiding any pressure points. (See
IFU for application of port)
Connect the Soft Port to the canister tubing. Activate the RENASYS device at
desired pressure and commence therapy.
Tips for success

• A leak in this type dressing is easily identified by a tactile coolness at the
site of the leak. Patch leak with Waterproof Tape or Transparent Film to
secure seal.
• Dressing should be comfortable. Remove dressing if any signs of
discomfort are experienced and seek alternative treatment regime.
50

8. RENASYS™ accessories
RENASYS Adhesive Gel Patch

The RENASYS Adhesive Gel Patch is designed for use with the existing Smith & Nephew NPWT
dressing kits. RENASYS Adhesive Gel Patch is a sterile, single use dressing. It is intended for
fixation of drainage tubing and is a useful accessory to help improve seals, especially in challenging
anatomical areas or with challenging wound and skin conditions. The Gel Patch is made of an
adhesive hydrogel sheet. This adhesive Gel Patch can be used as a replacement to Ostomy Paste.
The wear time is 72 hours.
Component list; 5 boxes per case
10 gel patches per box – 4in x 2.8in (10cm x 7cm)
Double sided silicone adhesive hydrogel
Application Tips
• The RENASYS Adhesive Gel Patch is intended to be used on intact skin. It is primarily used to
improve seals and avoid leaks.
• Used under the RENASYS Transparent Film, the Gel Patch can be cut and placed around the
periwound area prior to sealing with the RENASYS Transparent Film.
• It may be easier to cut or shape the RENASYS Gel Patch prior to removing the adhesive backing.
• When using gloves, remove one side of the adhesive backing and apply to the skin. Remove the
remaining panel once placed.
• The Gel Patch has absorbent properties, which means it has the ability to absorb reasonable
amounts of fluid. Depending on the wound output and conditions, it is possible to overwhelm the
dressing if enough fluid comes in contact. More frequent dressing changes may be needed as
directed in the Instructions for Use for RENASYS-G Gauze or RENASYS-F Foam Dressing Kits.
• The adhesive is designed to release off the skin with little or no adhesive remaining. If some
adhesive remains utilize Smith & Nephew’s REMOVE™ or another appropriate adhesive remover.
• Use gentile pressure to apply the RENASYS Adhesive Gel Patch to the dressing or skin site.


Section 8
RENASYS™ Adhesive Gel Patch application technique

Creating a seal around drain tubing or to lift drain
off skin
Cut the Gel Patch into strips in a direction that allows the backing
removal ends to remain accessible.
Remove the backing on one side only and apply to skin with gentle
pressure.
Remove the remaining backing and apply tubing.
Apply another strip using the same technique over the top of the tubing.
Ensure that the Gel Patch completely surrounds the tubing to create
a seal and remove the backing. Continue with normal dressing
application.
52

Creating a seal in challenging anatomical areas

Cut the Gel Patch into strips in a direction with backing removal ends
accessible.
pressure. Ensure the fold is addressed first.
Remove
interfacethe
andbacking.
the Gel Apply
Patch Transparent Filmand
to create a seal overfinish
the foam or gauze
the dressing.
Creating a seal around wound margins

Cut Gel Patch into several strips. Remove the backing on one side only
and apply to skin with gentle pressure. Remove the backing.
Continue to apply Gel Strips around wound margins ensuring that the
strips overlap to create a good seal. Continue with normal dressing
application.


Section 8
Creating a seal in challenging areas of the foot

Cut the Gel Patch into strips in a direction with backing removal ends
accessible.
pressure. Remove the backing. Apply Transparent Film over the foam
or gauze interface and the Gel Patch to create a seal and finish the
dressing.
Creating a seal around external fixation pins

Cut Gel Patch into strips and to a length that will cover the pin
circumference. Remove the backing on one side only. Apply the lead
end of the Gel Strip to the base of the pin. Gently apply pressure to the
backing to ensure initial adhesion to the pin. Wrap the Gel Strip around
the pin while simultaneously removing the backing.
Apply Transparent Film over the foam or gauze interface and the Gel
Patch. Pinch the film at the Gel Patch/pin interface to create a seal and
finish the dressing.
54

RENASYS™ Drain Accessory Kits

The RENASYS system offers a variety of drains to handle multiple wound types in all care
settings.
RENASYS drains provide a conduit for negative pressure and removal of exudate from the
wound cavity.
RENASYS Drain Accessory Kits are offered to complement the treatment of wounds. In
addition to RENASYS Soft Port, experienced clinicians who wish to enhance the treatment
regime of complex wound shapes and depths, locations, and challenging exudate
conditions can choose from several options.
All drains are silicone and include a radiopaque strip for visualization under X-ray. Utilized
in conjunction with the Soft Port, drains may further improve the removal of exudate from
wounds with the following characteristics:
• Irregular contours
• Challenging anatomical conditions
• Explored fistulae
• Significant wound depth, involving undermining, sinus tracts and tunneling.
The RENASYS-G Dressing Technique with the drains and/or Soft Port is the constant
factor that keeps the dressing change simple and cost effective. The variety of drains will
accommodate any wound size or exudate level and may be used in combination with the
Soft Port based upon clinical judgment, wound characteristics and desired clinical outcome
The RENASYS System allows the physician/clinician the flexibility to choose the
appropriate drain for the specific wound characteristics.
RENASYS 10 Fr Round Drain Accessory Kit

• The 10 French is designed for small, shallow wounds with minimal to no drainage. The
drain is perfect for addressing lightly exuding wounds.
• The drain can be curled inside the wound to increase the suction potential or used in a
linear fashion if curling is not possible.
• The design makes the round drain great for accommodating wounds with undermining.
• The drain is 100% silicone and radiopaque.
1 – RENASYS Y-Connector
1 – 10 Fr round drain
12–– strip
stripspaste
waterproof tape


Section 8
RENASYS™ 10mm Flat Drain Accessory Kit

• The 10mm Flat Drain is soft and perforated.
• Internal baffles prevent the drain from collapsing.
• The Flat Drain can be used on both deep and shallow wounds with minimal to heavy
drainage.
1 – flat drain 0.4in (10mm)
1 – strip paste
RENASYS 15 Fr Channel Drain Accessory Kit

• The Channel Drain can be used for wounds with up to moderate drainage.
• It is not designed for thick or sediment laden exudate.
• Its non-hollow, non-perforated design allows for insertion directly into tunnels without
being wrapped with gauze.
• A layer of gauze is recommended between the drain and the wound bed, but is not
necessary within the tunnel.
• The channel drain has four channels that run the length of the drain that perform as gutters
to guide exudate to the suction source.

• It is important to note that the “hub” or suction source must be contained inside the wound
bed.
• The “hub” is the junction between the drain and the tubing.
1 – 5 Fr. channel drain
1 – strip paste
56

RENASYS™ Y- Connector (included in Drain Accessory Kit and

separately in Kit Accessories)
• Compatible with RENASYS-F Foam Dressing and RENASYS-G Gauze Dressing Kits with
Soft Port
• Compatible with RENASYS EZ Plus and RENASYS GO canister tubing
1 – Y-Connector per kit
Ostomy Strip Paste (included in Drain Accessory Kit)

• Ostomy Strip Paste is utilized to obtain the initial dressing seal and maintain the seal
throughout the duration of the dressing.
• Ostomy Strip Paste prevents the drain from coming into contact with the patient's skin
where the drain exits the wound. This decreases the risk of pressure related breakdown in
this area.
• The Ostomy Paste can also be used to alleviate any skin irregularities that may make
getting a seal difficult (e.g. abdominal skin folds, cleft at the sacrococcygeal region).
• The Ostomy Paste can be used to completely border a wound located in an area that is
difficult to get a seal (e.g. perirectal).
Waterproof Tape (included in Drain Accessory Kit)

• Waterproof Tape has a Zinc based adhesive that ensures proper adherence while
remaining friendly to the patient’s intact skin.

• Waterproof Tape is used to secure the drain to prevent accidental removal from the wound
bed.
• The Chevron technique is utilized with the Waterproof Tape to secure the drain. This
technique was developed by nurses to secure IV tubing.


9. PICO™
Section 9 Single Use Negative Pressure Wound Therapy System
Description
The PICO Single Use Negative Pressure Wound Therapy System consists of a pump and two
sterile dressing kits. The PICO pump maintains negative pressure wound therapy at 80mmHg
(nominal) +/- 20mmHg to the wound surface. Exudate is managed by the dressing through a
combination of absorption and evaporation of moisture through the outer film. PICO is intended
for use in wound sizes (surface area x depth) up to 400cm3 which are considered to be low to
moderately exuding. The kit is intended to be used for a maximum of 7 days on low exuding
wounds and 6 days on moderately exuding wounds. Therapy duration of the kit may be less than
indicated if clinical practice or other factors such as wound type, wound size, rate or volume of
exudate, orientation of the dressing or environmental conditions, result in more frequent
dressing changes.
Indications for use

PICO is indicated for patients who would benefit from a suction device (negative pressure wound
therapy) as it may promote wound healing via removal of low to moderate levels of exudate and
infectious materials.
Examples of appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed surgical incisions
PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital
and homecare setting.
Contraindications
The use of PICO is contraindicated in the presence of:
• Patients with malignancy in the wound bed or margins of the wound (except in palliative care to
enhance quality of life).
• Previously confirmed and untreated osteomyelitis.
• Necrotic tissue with eschar present.
• Exposed arteries, veins, nerves or organs.
• Anastomotic sites.
• Emergency airway aspiration.
• Pleural, mediastinal or chest tube drainage.
• Surgical suction.
58

Warnings
1. Certain patients are at high risk of bleeding complications which, if uncontrolled, could potentially
be fatal. Patients must be closely monitored for bleeding. If sudden or increased bleeding is
observed, immediately discontinue therapy, leave dressing in place, take appropriate measures
to stop bleeding and seek immediate medical assistance.
2. The use of anticoagulants does not deem a patient inappropriate for treatment with PICO™
however hemostasis must be achieved before applying the dressing. Patients suffering from
difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of
bleeding. During therapy, avoid using hemostatic products that, if disrupted, may increase
the risk of bleeding. Frequent assessment must be maintained and considered throughout
the therapy.
3. At all times care should be taken to ensure that the pump and tubing does not:
• Lie in a position where it could cause pressure damage to the patient.
• Trail across the floor where it could present a trip hazard or become contaminated.
• Present a risk of strangulation or a tourniquet to patients.
• Rest on or pass over a source of heat.
• Become twisted or trapped under clothing or bandages so that the negative pressure is
blocked.
4. Sharp edges or bone fragments in a wound must be covered or removed prior to using PICO due
to risk of puncturing organs or blood vessels while under negative pressure.
5. In the event that defibrillation is required, disconnect the pump from the dressing prior to
defibrillation. Remove the dressing if it is positioned in a location that will interfere with
defibrillation.
6. MRI unsafe. PICO is not MRI compatible. Do not take PICO into the MRI suite.
7. PICO has not been studied on pediatric patients. Patient size and weight should be considered
when prescribing this therapy.
8. PICO is unsuitable for use in areas where there is danger of explosion (e.g. hyperbaric oxygen
unit).
Precautions
1. Precautions should be taken in the following types of patients who are at high risk of bleeding
complications:
• Receiving anticoagulant therapy or platelet aggregation inhibitors or actively bleeding.
• Having weakened or friable blood vessels or organs in or around the wound as a result of, but
not limited to; anastomoses, infection, trauma or radiation.
• Suffering from difficult wound hemostasis.
• Untreated for malnutrition.
• Noncompliant or combative.
• Suffering from wounds in close proximity to blood vessels or delicate fascia.
2. PICO dressings should only be applied by a healthcare professional. Dressings are not to be
removed or changed by the patient.
3. Where PICO is used on infected wounds, more frequent dressing changes may be required.
Regular monitoring of the wound should be maintained to check for signs of infection.
4. If deemed clinically appropriate, care should be taken that the application of a circumferential
dressing does not compromise circulation.


Section 9
5. PICO™ does not contain audible alarms. The pump should be carried so that it is accessible
and the patient/healthcare professional can check the status routinely.
6. Although PICO can be used under clothing/ bedding, it is important that occlusive
materials e.g. film dressings, are not applied over the pad area of the dressing as this will
impair device performance.
7. Where PICO is used on patients with fragile skin, a skin protectant such as SKIN-PREP™
should be used on areas of skin where fixation strips are to be applied. Inappropriate use
or repeated application of fixation strips may otherwise result in skin stripping.
8. If reddening or sensitization occurs discontinue use and contact the treating healthcare
professional.
9. Do not use PICO with oil-based products such as Petrolatum as it may compromise
establishing an effective seal.
10. The use of negative pressure presents a risk of tissue ingrowth into foam when this is
used as a wound filler. When using foam filler with PICO, tissue ingrowth may be reduced
by using a wound contact layer or by increasing the frequency of dressing changes.
11. PICO may be used in conjunction with surgical drains provided the dressing is not placed
over tubing
away where
from the edgeit of
exits
thethe skin. Any
dressing andsurgical
functiondrain should be routed
independently underSingle
of the PICO the skin
Use
Negative Pressure Wound Therapy System.
12. When showering the PICO pump should be disconnected from the dressing. Ensure the
end of the tubing attached to the dressing is facing down so that water does not enter the
top of the tube.
13. Do not take the pump apart.
14. The dressing should not be used with any other suction pump.
15. Do not alter or cut tubing configuration or pull on the tubing.
16. Do not cut the dressing as this may lead to loss of NPWT application.
17. Always ensure that the dressing is positioned centrally over the wound. The port should be
positioned uppermost
collecting around on intact
the port skin and not
and potentially extendthe
blocking over the wound
negative so that
pressure the risk of fluid
is minimized.
18. CT scans and X-ray have the potential to interfere with some electronic medical devices.
Where possible, move the device out of the X-ray or scanner range. If the device has been
taken into the CT scan or X-ray range, check that it is functioning correctly following the
procedure.
19. This device is single use only. Use of any part of this system on more than one patient may
result in cross contamination that may lead to infection.
20. High temperatures and humidity may reduce wear times of dressings.
21. During transport, there is a potential for radio frequency interference that could affect PICO
performance. If the device malfunctions, replace batteries. If not corrected, contact your
caregiver to replace the device. PICO is not intended for use aboard aircraft, the batteries
should be removed during air travel.
22. The potential for electromagnetic interference in all environments cannot be eliminated.
Use caution if PICO is near electronic equipment such as RFID (Radio Frequency
Identification) readers, anti-theft equipment or metal detectors.
23. Excessive bleeding is a serious risk associated with the application of suction to wounds
which may result in death or serious injury. Careful patient selection, in view of the above
stated contraindications, warnings and precautions is essential. Carefully monitor the
wound and dressing for any evidence of a change in the blood loss status of the patient.
Notify the healthcare professional of any sudden or abrupt changes in the volume or the
color of exudate.
60


1. Dressings should be changed in line with standard wound management guidelines,
typically every 3-4 days. More frequent dressing changes may be required depending
on the level of exudate, condition of the dressing, wound type/size, orientation of the
dressing, environmental considerations or other patient considerations; e.g. when
PICO is used on infected wounds. At the healthcare professional’s discretion a PICO™ A B C
dressing may be left in place for up to 7 days.
(A) Dressing properly positioned an
2. Inspect the dressing regularly. If the dressing appears ready for changing (see acceptable to be left in place
diagrams A-C), press the orange button and disconnect the dressing from the pump.
(B) Dressing requires change – Por
The fixation strips should be stretched away from the skin and the dressing lifted at block with fluid
one corner and peeled back until it has been fully removed. Apply another dressing,
connect to the pump and press the orange button to reinitiate the therapy. (C) Dressing requires change –
Absorbent area is full

Guidance
with PICO on wound suitability for management
PICO should be used on wounds which fit comfortably within the area of the pad,
observing precautions on port positioning (on intact skin and not extending over
the wound).
As a guide:
Depth – Wounds greater than 0.5cm (1/4in.) in depth are likely to require a foam or
gauze NPWT filler to ensure adequate treatment of all the wound surfaces. Wounds
treated with the larger dressing sizes of the PICO system should generally be no more
than 2cm (4/5in.) in depth.
Exudate
(nominally – PICO is liquid
0.6g of intended for use on
exudate/cm 2 wounds where the level of exudate is low
of wound area/24 hours) to moderate (nominally
1.1g of liquid exudate/cm2 of wound area/24 hours). 1g of exudate is approximately
equal to 1ml of exudate. When used on a moderately exuding wound, the size of the
wound should generally be no more than 25% of the dressing pad area.


Section 9
Instructions for use

Application
1. Remove anyirrigate
necessary, excessthe
hair to ensure
wound close approximation
with sterile saline and patofthe
thewound
dressing
dry.to the wound. If
2. Using a clean technique, peel off the central release handle and place the dressing
centrally over the wound to reduce the chance of wound fluid coming into contact with
the port. The port should be uppermost from the wound (depending on the patient’s
primary position), placed on intact skin and not extend over the wound to prevent fluid
pooling around the port and blocking the negative pressure. Remove the other two
handles and smooth the dressing around the wound to prevent creasing. Reposition if
required to ensure border is not creased.
3. Once the dressing is in place, remove the pump and the batteries from the tray. Insert
the batteries. Replace the cover. Following this all three lights should flash once (refer to
Appendix VI – PICO™ IFU, table 1 on page 72).
4. Join the pump to the dressing by twisting together the tubing connectors. Press the
orange button to start the application of negative pressure. The green light will start to
flash indicating the system is working properly.
Depending on the size of the wound, the pump should take up to 30 seconds to establish
negative pressure wound therapy.
If after 30 seconds the system has not established negative pressure wound therapy,
the amber air leak light will illuminate. To troubleshoot refer to section (ii) of Appendix VI –
PICO IFU, table 1 on page 72.
5. If using SKIN-PREP™ prior to application of the fixation strips (see Precautions), wipe the
area surrounding the dressing and allow skin to dry.
6. Apply the fixation strips to each of the four sides of the dressing. Remove top carrier on
the strip after each one has been applied. These strips maintain the seal over the wear
time of the dressing. In awkward areas, it may be useful to apply the strips to help achieve
a seal prior to switching on the pump. Place each strip so that it overlaps the dressing
border by approximately 1cm (2/5in.). Ensure tubing is not twisted or trapped between
clothing.
Please note that if at any time the fixation strips are removed, the dressing should also
be replaced.
62

Use with fillers and wound contact layers

PICO™ is compatible with standard gauze and foam fillers used in traditional NPWT where this is
clinically appropriate – for example on a defect wound. When a filler is used, the filler and the PICO
dressing should be changed 2 to 3 times a week, according to local clinical protocol and manufacturer’s
instructions. Gauze should loosely fill to the surface of the wound. Avoid over packing.
PICO may be used over the top of a non-adherent layer if required, for example over a skin graft. On
infected wounds or wounds at risk of infection. ACTICOAT™ Flex Silver-coated Antimicrobial Dressings
may be used under PICO.
General use
Showering and bathing
Light
in showering
a safe locationiswhere
permissible; however,
it will not get wet.the
Thepump should
dressing be disconnected
should (seetoPrecautions)
not be exposed and
a direct spray or placed
submerged in water. Ensure the end of the tubing attached to the dressing is facing down so that water
does not enter the top of the tube.
Cleaning
Adherence to clinical directives concerning hygiene is of prime importance. The pump may be wiped
clean with a damp cloth using soapy water or a weak disinfectant solution.


10. Clinical
Section 10 Hotline
For clinical support regarding Smith & Nephew NPWT

devices call 1-800-876-1261.
A Clinical Hotline is available to assist patients and healthcare
providers with any questions related to Smith & Nephew's NPWT
System. This includes generalized questions from the dressing
techniques to troubleshooting an alarm situation.
The Hotline is available 24 hours a day, 7 days a week.
Or visit www.myrenasys.com or www.possiblewithpico.com.
64

11. Appendix
Appendix I RENASYS GO NPWT System
Negative Pressure Wound RENASYS GO device

Product description Product code
Therapy product portfolio RENASYS GO Smith & Nephew
66800164
Component list
Smith & Nephew prides itself in delivering an innovative Acute Care (UHS)
and comprehensive NPWT product portfolio that • Pump
• Power cord
ZNG
offers flexibility and clinical excellence. Our extensive • Quick reference guide Home Care (Apria)
M040511
selection of pumps, canisters, kits and accessories • Strap
are each conformably designed to meet the unique
complexities of your patients’ wounds. The RENASYS™
NPWT System helps improve the overall patient RENASYS GO canisters
experience by promoting wound healing throughout the 750mL with solidifier:
RENASYS GO Large Canister (750mL)
entire continuum of care. Smith & Nephew
Component list; 5 per case 66800916
• Sealed canister
Acute Care (UHS)
RENASYS EZ Plus NPWT System • Solidifier 2012250
• Canister tubing
RENASYS EZ Plus device
300mL with solidifier:
Product description Product code Canister
RENASYS(300mL)
GO Smith & Nephew
66800914
RENASYS EZ Plus Smith & Nephew Component list; 5 per case
66800697 Acute Care (UHS)
Component list • Sealed canister 2012000
• Pump Acute Care (UHS) • Solidifier
ZNP Home Care (Apria)
• Canister holder kit • Overflow guard with silicone tubing M047406
• Power cord Home Care (Apria) • Canister tubing
M046689
• Quick reference guide
RENASYS GO accessories
RENASYS GO Smith & Nephew
66800161
RENASYS EZ Plus canisters Power Supply
External Cord Acute Care (UHS)
1901102
800mL S-Canister 800mL with solidifier: 1 per case
Smith & Nephew Home Care (Apria)
• Sealed
canister 66800912 R037398
Acute Care (UHS)
• With or without solidifier 2012025 RENASYS GO Smith & Nephew
66800162
• Overflow guard with silicone tubing
Home Care (Apria)
Carrying Case
• Canister tubing Acute Care (UHS)
M047411 1 per case 2009525
800mL without solidifier:
Home Care (Apria)
250mL S-Canister Smith & Nephew
R037471
66801066
Component list;
10 kits per case Acute Care (UHS) RENASYS GO Smith & Nephew
TBD 66800163
• Sealed canister Carrying Straps
• Solidifier Acute Care (UHS)
250mL with solidifier: Component list; 1 per case
• Overflow guard with silicone tubing 2009550
Smith & Nephew • Straps include fix-lock
• Canister tubing 66800913 buckles, shoulder pad Home Care (Apria)
and strap extender R037472
Acute Care (UHS)
2012225
RENASYS EZ Plus accessories PICO™ Single Use NPWT System

RENASYS EZ Plus Smith & Nephew
66800060
PICO device
Canister Holder Kit
Acute Care (UHS) Product description Product code
(accommodates all canister sizes)
2009475
1 per case Dressing size 4in x 8in Smith & Nephew
(10cm x 20cm) 3 kits/case 66800862
RENASYS EZ Power Cord Smith & Nephew

66800193 Smith & Nephew
Hospital Grade Dressing size 4in x 12in
Acute Care (UHS) (10cm x 30cm) 3 kits/case 66800863
1 per case 2008025


Section 11
Product description Product code Product description Product code
Dressing size 6in x 6in Smith & Nephew RENASYS-G Smith & Nephew
(15cm x 15cm) 3 kits/case 66800865 Gauze Dressing Kit Sterile with Soft Port 66800961
Component list; 5 kits per case Acute Care (UHS)
• 1- Soft Port – length 27in (69cm) 2012325
Dressing size 6in x 8in Smith & Nephew applicator head 6in x 4in (15cm x 10cm)
(15cm x 20cm) 3 kits/case 66800866
• 1- AMD gauze dressing 6in x 6.7in (15cm x 17cm)
• 1 - AMD gauze roll 4.5in x 4.1yd (11cm x 4m)
Carry Bag 1/each Smith & Nephew
66800918
• 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
RENASYS High Output Dressing Kit Smith & Nephew

66800932
Gauze • 2 - 30mL saline bullets Acute Care (UHS)
• 4 - strips waterproof tape 2011100
Product description Product code
• 1 - strip paste Home Care (Apria)
TBD
RENASYS ™ -G Smith & Nephew • 1 - wound ruler
Gauze Dressing Kit with Soft Port – Small 66800933 • 2 - sachets of NO-STING SKIN-PREP
Component list; 5 kits per case Acute Care (UHS) • 1 - 28 Fr round aspiration/irrigation drain 3ft (92cm)
• 1 - saline bullet 30mL 2012275 • 2 - non-adherent gauze 3in x 8in (8cm x 20cm)
• 1 - wound ruler Home Care (Apria) • 2 - AMD gauze rolls 4.5in x 4.1yd (11cm x 4m)
• 1 - sachet of NO-STING SKIN-PREP™ M047408 • 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm) Foam
• 1 - AMD gauze dressing 6in x 6.7in (15cm X 17cm) Product description Product code
• 1 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - non-adherent gauze 3in x 8in (8cm x 30cm)
RENASYS-F Smith & Nephew
Foam Dressing Kit with Soft Port – Small 66800794
RENASYS-G Smith & Nephew
• 1 - Soft Port – length 27in (69cm) 2012050
Gauze Dressing Kit with Soft Port – Medium 66800934
applicator head 6in x 4in (15cm x 10cm) Home Care (Apria)
Component list; 5 kits per case Acute Care (UHS) • 1 - foam block 4in x 3in x 1in (10cm x 8cm x 3cm) M047414
• 1 - saline bullet 30mL 2002225 • 1 - RENASYS Transparent Film 8in x 12in (20cm x 30cm)
• 1 - wound ruler Home Care (Apria)
• 1 - sachet of NO-STING SKIN-PREP M047409 RENASYS-F Smith & Nephew
• 1 - Soft Port – length 27in (69cm) Foam Dressing Kit with Soft Port – Medium 66800795
applicator head 6in x 4in (15cm x 10cm) Component list; 5 kits per case Acute Care (UHS)
• 2 - AMD gauze dressings 6in x 6.7in (15cm x 17cm) • 1 - Soft Port – length 27in (69cm) 2012075
• 1 - RENASYS Transparent Film 8in x 12in (20cm x 30cm) applicator head 6in x 4in (15cm x 10cm) Home Care (Apria)
•• 12--foam blockTransparent
RENASYS 8in x 5in x 1in (20cm
Films 8in xx 13cm x 3cm)x 30cm)
12in (20cm M047415
RENASYS-G Smith & Nephew RENASYS-F Smith & Nephew

Gauze Dressing Kit with Soft Port – Large 66800935 Foam Dressing Kit with Soft Port – Large 66800796
Component list; 5 kits per case Acute Care (UHS) Component list; 5 kits per case Acute Care (UHS)
• 1 - saline bullet 30mL 2002200 • 1 - Soft Port – length 27in (69cm) 2012100
• 1 - wound ruler Home Care (Apria) applicator head 6in x 4in (15cm x 10cm) Home Care (Apria)
• 1 - sachet of NO-STING SKIN-PREP M047410 • 1 - foam block 10in x 6in x 1in (25cm x 15cm x 3cm) M047407
• 1 - Soft Port – length 27in (69cm) • 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - AMD gauze roll 4.5in x 4.1yd (11cm x 4m) RENASYS-F Smith & Nephew
• 2 - RENASYS Transparent Films 8in x 12in (20cm x 30cm) Foam Dressing Kit with Soft Port – X-Large 66800797
• 1 - Soft Port – length 27in (69cm) 2012125
RENASYS-G Smith & Nephew • 1 - foam block 20in x 25in x 0.6in (50cm x 63cm x 1.5cm)
Gauze Dressing Kit with Soft Port – X-Large 66800936 • 6 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 2- saline bullets 30mL 2012300
RENASYS AB Smith & Nephew
• 1 - wound ruler Abdominal Dressing Kit with Soft Port 66800980
• 1 - Soft Port – length 27in (69cm)
applicator head 6in x 4in (15cm x 10cm) 2012150
• 2 - sachets of NO-STING SKIN-PREP • 1 - Soft Port – length 27in (69cm)
• 4 - non-adherent gauze 3in x 8in (8cm x 20cm) applicator head 6in x 4in (15cm x 10cm)
• 2 - AMD gauze rolls 4.5in x 4.1yd (11cm x 4m) • 2 - foam blocks 17in x 12in x 1in (43cm x 30cm x 3cm)
• 3 - RENASYS Transparent Films 8in x 12in (20cm x 30cm) • 6 - RENASYS Transparent Films 8in x 12in (20cm x 30cm)
• 1 - organ protection layer 35in x 26in (89cm x 66cm)
66

Kit accessories
Product description Product code Product description Product code
NPWT Antimicrobial Large Gauze Roll Smith & Nephew RENASYS Adhesive gel patch Smith & Nephew
66800391 66801082
Component list; 10 kits per case Component list; 5 boxes per case
• 5 - rolls of gauze Acute Care (UHS) • 10 gel patches per box Acute Care (UHS)
individually packaged 2007700 4in x 2.8in (10cm x 7cm) TBD
per kit Home Care (Apria)
M039970 • Double sided silicon adhesive hydrogel Home Care (Apria)
TBD
RENASYS™ Transparent Film Smith & Nephew

66800394
• 10 - Transparent Films per kit Acute Care (UHS)
8in x 12in (20cm x 30cm) 2007775
Home Care (Apria)
M040105
RENASYS Transparent Film X-Large Smith & Nephew

66800853
• 5 - Transparent Films per kit Acute Care (UHS)
16in x 25in (40cm x 60cm) 2012200
RENASYS Y-Connector Smith & Nephew

Component list; 10 kits per case 66800971
• 1 - Y-Connector per kit Acute Care (UHS)
2002250
Home Care (Apria)
M047412
RENASYS Soft Port Stand-Alone Kit Smith & Nephew

66800799
• 1 - Soft Port per kit Acute Care (UHS)
Length 27in (69cm) 2012350
applicator head 6in x 4in
(15cm x 10cm)
RENASYS 10 Fr Round Drain Accessory Kit Smith & Nephew

66800972
• 1- RENASYS Y-Connector Acute Care (UHS)
• 1- 10 Fr round drain 2012375
• 1- strip paste
• 2-strips waterproof tape
RENASYS 10mm Flat Drain Accessory Kit Smith & Nephew

66800973
• 1- flat drain 0.4in (10mm) 2012400
• 1- strip paste
RENASYS 15 Fr Channel Drain Accessory Kit Smith & Nephew

66800974
2012425
•• 1-
1- strip
15 Fr.paste
channel drain


Section 11
EN
Appendix II RENASYS™
Foam and Gauze Dressing Kits with Soft Port
Negative Pressure Wound Therapy Do not reuse Keep dry
INDICATIONS FOR USE Examples of appropriate wound types include: CONTRAINDICATIONS

The RENASYS-F foam dressing kits and the RENASYS-G gauze  Chronic The use of NPWT is contraindicated for:
dressing kits with Soft Port are intended to be used in conjunction  Acute  Untreated osteomyelitis
with Smith & Nephew Negative Pressure Wound Therapy (NPWT)  Traumatic  Exposed arteries, veins, organs or nerves
Systems. The Smith & Nephew RENASYS NPWT System is indicated  Sub-Acute and dehisced wounds  Necrotic tissue with eschar present
for patients who would benefit from a suct ion device (negative  Ulcers (such as pressure or diabetic)  Malignancy in the wound (with exception of palliative care to
pressure wound therapy) as it may promote wound healing via  Partial-thickness burns enhance quality of life)
the removal of fluids including irrigation and body fluids, wound  Flaps and grafts  Non-enteric and unexplored fistulas
exudates and infectious materials.  Anastomotic sites
WARNINGS closer under the ac tion of negative pressure. be observed whenever working with potentially contaminated part s
1. Carefully monitor patients for signs of sudden or increased bleed- 4. Foam or gauze must not be tightly packed or forced into any or equipment.
ing. If such symptoms are observed, immediately discontinue wound area. 8. NPWT has not been studied on pediatric patients. Patient size
therapy, take appropriate measures to control the bleeding, and 5. In the event defibrillation is required, disconnect the device from and weight should be considered when prescribing RENASYS
contact the treating clinician. the wound dressing prior to defibrillation. Remove the wound dress- devices.
2. Patients suffering from difficult hemostasis or who are receiving ing only if its location will interfere with defibrillation. 9. RENASYS devices are unsuitable for use in areas where there is
anticoagulant therapy have an increased risk of bleeding. During 6. RENASYS devices are not MRI compatible. Do not bring t he danger of explosion (e.g., hyperbaric oxygen unit, or in the presence
therapy, avoid using hemostatic products that, if disrupted, may RENASYS device into the MRI suite. of a flammable anesthetic mixture with air or nitrous oxide). Discon-
increase the risk of bleeding. 7. When operating, transporting, repairing or disposing of nect the device from the dressing prior to entering an area where
3. Do not use on exposed blood vessels or organs. Sharp edges RENASYS devices and accessories, the risk of infectious liquids this equipment will be used.
such as bone fragments must be covered or removed prior to initiat- being aspirated, or contamination of the device assembly through 10. Canister kits are provided non-sterile and should not be placed
ing therapy, due to risk of puncturing organs or blood vessels drawn incorrect use, cannot be eliminated. Universal precautions should within a sterile field.
PRECAUTIONS 5. Inspect thebacterial overflow guard on the canister and replace be disconnected from the RENASYS device is a cl inical decision
NOTE: Full device operation is found in the User Guide for each the canister as necessary. At minimum, the canister should be based on individual characteristics of the patient and the wound.
RENASYS device. changed weekly. Always use t he smallest canister volume possible Factors to consider include the location of the wound, the volume
1. Precautions should be taken for patients who are or may be: – do not use a large canister on patients with a high risk of bleeding. of drainage, the integrity of the dressing seal, the assessment of
 Receiving anticoagulant therapy or platelet aggregation inhibitors. 6. If any liquids penetrate the RENASYS device, discontinue use and bacterial burden and the patient’s risk of infection.
return to your authorized provider for service. 13. Ensure that tubing and Soft Port is installed completely and with-
 Actively bleeding or have friable blood vessels or organs.
 Suffering from abnormal wound hemostasis. 7. Do not use a dressing kit with breached or damaged packaging. out any kinks to avoid leaks or blockages in the vacuum circuit. Posi-
 Untreated for malnutrition. 8. The use of NPWT presents a risk of tissue in-growth. Tissue tion the RENASYS device and tubing appropriately to avoid the risks
 Noncompliant or combative. in-growth may be reduced by reducing therapy pressure, using of causing a trip hazard. Wherever possible, the device and system
 Suffering from wounds in close proximity to blood vessels or fri- a wound contact layer or by increasing the frequency of dressing tubing should be positioned level with or below the wound.
able fascia. changes. 14. When bathing or showering, the patient must disconnect from
2. CT scans and x-ray have the potential to inter fere with some 9. Underlying structures, such as t endons, ligaments and nerves the RENASYS device and should protect both ends of the tubing
electronic medical devices. Where possible, move the device out of should be covered with natural tissue or a non-adherent dressing using the tethered cap. Ensure that the aeration disc, located near
the x-ray or scanner range. If the d evice has been taken into the CT layer prior to applying the NPWT dressing kit. the quick click connector, is free of excess moisture before reactiva-
scan or x-ray range, check that it is functioning correctly following 10. If multiple pieces of foam or gauze are needed to f ill the wound tion of therapy.
profile, count and record how many pieces are present to ensure all 15. NPWT should not be painful. If the patient reports discomfort,
the procedure.
3. As a condition of use, the RENASYS device should only be used the pieces are removed at a dressing change. consider reducing the pressure.
11. Infected wounds may require more frequent dressing changes. 16. Maintain regular monitoring of the RENASYS device and wound
by qualified and authorized personnel. The user must have the
necessary knowledge of the specific medical application for which Regular monitoring of the wound should be maintained to check for site during therapy to ensure therapeutic treatment and patient
NPWT is being used. signs of infection. comfort.
17. As with all adhesive products apply and remove the dressing
4. If the RENASYS device has been at temperatures below freezing, 12. NPWT should remain on for the duration of the treatment. If the
the device must be brought to room temperature prior to use or the patient must be disconnected, the ends of the tubing should be carefully from sensitive or fragile skin to avoid skin stripping, espe-
pump unit may be damaged. protected using the tethered cap. The length of time a patient may cially after frequent dressing changes.
PRECAUTIONS SPECIFIC TO FOAM 2. Never place foam into blind or unexplored tunnels. If a tunnel 3. Do not cutthe foam directly over the wound cavity to avoid foam
1. Foam should be cut to fit loosely into wound bed. Never force or of known depth presents, cut the foam longer than the tunnel, to fragments from falling into the wound. Rub the edges of the foam,
tightly pack foam into any areas of t he wound, to avoid damaging ensure direct contact is made with t he foam in the primary wound away from the open wound, to remove loose fragments after cutting.
underlying tissue. cavity.
CLEAN AND DEBRIDE 1. Cover intact skin with t ransparent film wherever bridge will be INITIATE THERAPY
Use clean or aseptic techniques for application, according to your placed. 1. Connect the RENASYS Soft Port to the canister tubing by pushing
institutional protocol. Thorough wound cleansing should occur with
each dressing change. 2. Layer additional foam or gauze on top of the wound f iller and any the quick click connectors together. An audible click indicates the
film intended to support bridging materials. Ensure contact with the connection is secure.
1. Debride any devitalized or necrotic eschar filler in the wound cavity is made. 2. Activate the RENASYS device and adjust to the prescribed
tissue. Cleanse the wound bed and pat dry. therapy level. The recommended therapeutic pressure range is
3. Proceed to “SEAL THE WOUND”
40 – 120 mmHg.
SEAL THE WOUND  The vacuum level is a decision each healthcare provider must
make, based on an individual assessment of the particular
2. If desired, protect periwound skin from 1. While holding the transparent film,
expose
exposure to moisture and adhesive through the wound.
one side of the adhesive backing by removing
use of a skin sealant. a single panel, and apply over the wound.  Lower levels of vacuum are generally effective and more toler-
able.
2. Cover wound filler with transparent film,  The vacuum level should never be painful. If the patient reports
3.If desired, a non-adherent dressing may be
removing remaining adhesive panels to seal, discomfort with the vacuum level, it can be reduced.
applied. Trim a single layer of non-adherent
then the top stabilization panel. 3. Finished dressings should be firm to the touch and leak-free.
gauze and lay across wound bed.
Note: Avoid stretching or pulling the transparent film to minimize DRESSING CHANGES

Note: Skin sealant and wound contact layer is not included as part 1.            
tension or trauma to the periwound skin.
of RENASYS-F or RENASYS-G Sterile Kit. initial application of therapy. If no leak is present and the patient is
Recommendations: comfortable, dressing changes should occur no less than 3 times
DRESS WOUND WITH FOAM OR GAUZE          per week.
Review Precautions Specific To Foam before continuing. It is wound margin and be securely anchored to 2. Gauze dressings should be changed 48 hours after the initial
critical that foam is not forced into any wound, or placed within an periwound area to maintain a good seal.
 application of therapy. If no leak is present and the patient is
unexplored tunnel.
comfortable, dressing changes should occur 2-3 times per week.
4. Foam: Cut thefoam dressing to fit the size             
when using multiple pieces of transparent film. 3. In theevent of heavy drainage or drainage with sediment, more
and shape of the wound and place the cut
frequent dressing changes may be needed.
foam into the wound. Avoid over packing. Foam
should completely fill the wound cavity. It may APPLY RENASYS SOFT PORT : 4. Ensure all wound filler material placed in the wound has been
be necessary to stack pieces of foam in deep removed before redressing the wound. I f foam dressing adheres
wounds. 1. Cut a small opening (no less than 2cm) to the wound, apply normal saline into the wound dressing and
in the center of the film, over the wound let it set for 15-30 minutes before gently removing the foam.
4. Gauze: Apply a layer of saline-moistened  filler. Remove any loose transparent film and Appropriately discard used wound dressings observing your
antimicrobial gauze to wound bed (saline dispose of away from the wound. institution’s protocol for medical waste handling.
not included in RENASYS-G Sterile OR Kit).
Continue to apply in layers, until t he gauze 2. Remove the adhesive panel 5. As with all adhesive products apply and remove the dressing
loosely fills the entire wound cavity. Avoid over from the Soft Port dressing, and carefully from sensitive or fragile skin to avoid skin stripping,
packing the wound. align the port opening directly over especially after frequent dressing changes.
the hole in the transparent film.
Precaution: If multiple pieces of wound filler are needed to fill the Use gentle pressure to anchor the Soft Port t o the transparent film. 6. Check the dressing regularly. Throughout treatment, monitor the
wound cavity, count and record how many pieces are present to patient for any signs of local or systemic infection. Infected wounds
ensure all wound filler p ieces are removed at a dressing change. 3. Smooth the dressing down while removing may require more frequent dressing changes. If there are any signs
the Soft Port’s top stabilization frame. of systemic infection or advancing infection at the wounded area,
BRIDGING AWAY FROM WOUND contact the treating clinician immediately.
Under normal circumstances using Soft Port, it should not be
7. If t he RENASYS device reports a blockage alarm, inspect the
necessary to bridge away from wounds. If this is the case proceed 4. Secure the Soft Port to the patient
according to your institutional protocol. Ensure dressing and canister tubing for any blockages which may be
to “SEAL THE WOUND.” If there is still concern that the Soft Port manually remedied. If a blockage cannot be identified or resolved,
may create pressure at the wound, due to the wound’s location and the aeration disc, located near the q uick
click connector, is not covered or otherwise replace the device canister first, and then replace the dressing and
conditions, or if the wound is smaller t han the Soft Port opening Soft Port as necessary.
(1.5 cm), utilize the bridge technique. This technique will allow the occluded by the method used to secure the
Soft Port to be redirected to a non-weight bearing area. Soft Port.
68

*smith&nephe
EN
Appendix III INDICATIONS FOR USE

The RENASYS™ AB Abdominal Dressing Kit with Soft Port
 Sharp edges such as bone fragments must be covered
or removed prior to initiating therapy, due to risk of punc
PRECAUTIONS
NOTE:           RENASYS™ AB
(RENASYS AB) is intended for use in conjunction with turing organs or blood vessels drawn closer under the RENASYS EZ and RENASYS EZ PLUS.
RENASYS EZ and RENASYS EZ PLUS devices and action of negative pressure.           Abdominal Dressing Kit
canisters as a complete Negative Pressure Wound                     with Soft Port
Therapy (NPWT) System for managing open abdominal                   
wounds with NPWT. defect once the OPL has been placed. protect the tube ends by inserting the tethered caps of Do not use
                         Do not
if packge is
abdominal wall openings where primary closure is not device from the wound dressing prior to defibrillation. the device. reuse
damaged
possible and/or repeat abdominal entries are necessary. Remove the wound dressing only if its location will inter           
           fere with defibrillation. some electronic medical devices. Where possible, move Storage Sterilized u
temperature ethyleneox
with exposed viscera, including but not limited to                       
abdominal compartment syndrome.                       
             When operating, transporting, repairing or disposing of it is functioning correctly following the procedure.
hospital care settings (trauma, general and plastic surgery RENASYS devices and accessories, the risk of infectious                  
wards) and should ideally be applied in the operating liquids being aspirated, or contamination of the device be positioned level with or below the wound.        
theatre. assembly through incorrect use, cannot be eliminated.  The length of time a patient may be disconnected from weekly canister change is recommended. Always use
CONTRAINDICATIONS Universal precautions should be observed whenever RENASYS EZ or RENASYS EZ PLUS device is a clinical deci smallest practical canister size, based on the patient’s
The use of RENASYS AB is contraindicated: working with potentially contaminated parts or equipment. sion based on individual characteristics of the patient and and weight, to avoid risk of significant and or unintend
                   fluid and blood loss.
    
RENASYS AB have not been studied on pediatric patients. age, integrity of the dressing seal, assessment of bacterial        
    RENASYS AB with the RENASYS EZ or RENASYS EZ PL
Patient size and weight should be taken into account burden in the wound, and patient’s risk of infection.
           when prescribing this device.              
care to enhance quality of life)  RENASYS devices are unsuitable for use in areas where NPWT system must only be applied and operated by          
          there is danger of explosion (e.g., hyperbaric oxygen unit, qualified and authorized personnel. The user must have return to your authorized provider for service.
the Organ Protection Layer (OPL). or in the presence of a flammable anesthetic mixture the necessary knowledge of the specific medical applica            
        with air or nitrous oxide). Disconnect the device from the tion for which RENASYS AB is indicated. event packaging is breached, please contact Smith &
           dressing prior to entering an area where this equipment         Nephew customer service.
hemorrhage and/or enteric leak. will be used. device and tubing, from wound site to canister, to ensure        
         therapeutic benefit and patient comfort. according to your institution’s protocols, to minimize th
         sterile and should not be used in a sterile field.                  
bowel, arteries, veins, organs, or nerves. risks of causing a trip hazard and of the patient lying on may include use of sterile gowns and eye protection w
Utilize the OPL at all times when using the RENASYS AB the tubing. severely contaminated wounds.
with the RENASYS NPWT System. PRECAUTIONS SPECIFIC TO RENASYS AB
NOTE: Ensure aseptic technique is used during the appli standard treatment regimen, and/or to provide a barrier to dominal contamination if output is not carefully manag
WARNINGS cation of all components of RENASYS AB. Ensure the abdo bacterial penetration. during the course of treatment with RENASYS AB.
men and its contents are adequately visualized, controlled                     
        
and protected throughout application of the dressing. from the abdominal wall. Preventing adhesions or obstruc ing and NPWT system will remove third space fluid in t
tion. Carefully monitor patients undergoing treatment with
        tions that may otherwise form during open abdominal abdominal compartment. Large volumes of fluid can be
         
be undertaken as part of a holistic medical manage wound management is a critical parameter in achieving collected during the course of treatment. The volume a
such symptoms are observed, immediately discontinue
therapy, take appropriate measures to control the bleed ment strategy, with the goal of reducing the patient’s timely
fistula primary facial closure
development. The OPLand reducing
must t he chance
completely cover allof appearance
be checked andof the fluid in both
recorded canister
frequently andpatient
while tubingissho
ing, and contact the treating clinician. Precautions should       
         exposed viscera, prior to application of wound filler and receiving therapy. The canister should be replaced prio
be taken for patients who are, or may be:
      subsequent activation of the NPWT system.       
– Receiving anticoagulant therapy or platelet aggregation of blockage in the system; monitor closely.
Syndrome (ACS), as well as other factors (including the         
inhibitors.
patient’s size, weight, and unique clinical situation). suffering from intestinal obstruction in the small or large             
– Actively bleeding or have friable blood vessels or organs.       bowel, which may include (but is not limited to) hernias, proximate guide when considering the necessity of flu
– Suffering from abnormal wound hemostasis.        adhesions from previous abdominal surgery, or from un resuscitation. Planning for fluid replacement should be
– Untreated for malnutrition. (APP) are recommended before, during and after treat         clinical consideration in all patients undergoing therap
– Noncompliant or combative. ment with RENASYS AB, as a means of guiding clinical         with RENASYS AB.
decisions concerning management of the open abdomen. cated by dehydration and/or loss of electrolytes – this is         
– Suffering from wounds in close proximity to blood ves
          especially the case if the patient has bowel exposed. adhesive irritation may be accomplished through the u
sels or friable fascia.
ment for infection in the open abdomen. RENASYS AB                  
may, however, be used on septic open abdomens, which cluding, but not limited to arterial grafts or gastric bypass) to the per iwound area, foam should never overlap ont
are being managed in accordance with institutional clinical require careful consideration while using RENASYS AB. intact skin without first protecting the skin with additio
protocols for infection abatement, as an adjunct to the Patients with enteric fistula have an increased risk of ab transparent film or a hydrocolloid dressing.
RENASYS AB ABDOMINAL DRESSING KIT 66800980 INCLUDES: COMPATIBLE DEVICES COMPATIBLE CANISTERS
w w w w w w w
h e p h e p h e p h e p h e p h e p h e
2 n e p
& & n e S ™ & n e S ™ n e S ™
& & n e S ™ & n e S ™ 2 n e
&
i t h E ™ i t h S Y i t h S Y i t h S Y i t h S Y i t h S Y i t h E ™
s m S I T s m N A s m N A s m N A s m N A s m N A s m S I T
* O P * R E * R E * R E * R E * R E * O P
2 2
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e h w
e h w
e h we h e w h w
e
n e p n e p ™ n e p ™ n e p ™ n e p ™ n e p ™ n e p 800ml
i t h & E ™
m i t h & S Y S
m i t h & S Y S
m i t h & S Y S
m i t h & S Y S
m i t h & S Y S
m i t h & E ™
m
s S I T s N A s N A s N A s N A s N A s S I T 90 10 0
700ml
* O P2 * R E * R E * R E * R E * R E * 2 O P
80 12 0 9 0 10 0
80 12 0
70
14 0
60 16 0
70
14 0 600ml
w w e w e w w w w
60 16 0
h e p h e p h e

50 18 0
500ml
2 p e p h e p h e p h e e p h e
40 200 50 18 0
2 n e
40 200
h & n e ™ h & n e Y S ™ h & n Y S ™ h & n Y S ™ h & n Y S ™ h & n Y S ™ h & ™

m i t S I T E m i t A S m i t A S m i t A S m i t A S m i t A S m i t S I T E 400ml
* s O P * s R E N * s R E N * s R E N * s R E N * s R E N * s O P
300ml
2 2
h e w h e w h e w h e w h e w h e w h e w
n e p n e p ™ n e p ™ n e p ™ n p n p n p
200ml
e ™ e ™ e
t h & E ™ h & Y S
m i t A S
h & Y S
m i t A S
h & Y S
m i t A S
h & Y S
m i t A S
h & Y S
m i t A S
h & ™
m i2 t S I T E
m i S2 I T
* s O P * s R E N * s R E N * s R E N * s R E N * s R E N * s O P 100ml
Organ Protection Layer (OPL) Perforated Foam Transparent Film Soft Port RENASYS EZ RENASYS EZ PLUS 800ml 250m
1 ea. 2 ea. 6 ea. 1 ea. 66800059 66800697 

66800937 
668009
PREPARATION OF OPEN ABDOMINAL WOUND PERFORATED FOAM APPLICATION 5.0cm

2. Cover foam with transparent INITIATION OF THERAPY
film, removing remaining adhesive
WARNING: Review all RENASYS NPWT System safety 1. Size the provided foam to the 1. Ensure canister is installed correctly. Connect the
7.5cm
panels to seal, as well as the re
information prior to beginning Wound Preparation. Ensure     suction port tubing to the canister tubing by pushing t
    
that sufficient hemostasis has been achieved prior to scored perforations. Cutting the extend at least 5cm beyond connectors together. An audible click indicates the co
        wound filler may be performed wound margin and be securely nection is secure.
 if desired. Do not cut the foam anchored to periwound area to 2. Activate the RENASYS EZ or RENASYS EZ PLUS dev
wound filler directly over the maintain a good seal.       
1. Eliminate any sharp edges or bone fragments from wound bed to avoid foam frag
check that the dressing has a good seal. The recom
      ments from falling into the wound. Rub the edges of NOTE: Overlap the edges of the transparent film by a
    
any cut foam, away from wound, to remove any loose minimum of 7.5cm when using multiple pieces of transpar 
2. Ensure any areas of necrosis are appropriately de 
fragments which may result. The foam should be placed ent film. 3.        
brided.
directly over the OPL while maintaining contact with the NOTE: Avoid stretching or pulling the transparent film to 4.         
3.      margins of the wound. minimize tension or trauma to the periwound skin.
4. Clean and dry the periwound area.
DRESSING CHANGES
2. Do not allow foam to contact intact skin without use of SOFT PORT APPLICATION
appropriate barrier, such as transparent film or a hydrocol PRECAUTION: Protect the tube ends by inserting the
ORGAN PROTECTION LAYER (OPL) APPLICATION 1. Cut a small opening (no less
                  
WARNING: Protect vital structures such as bowel and         than 0.6cm) in the center of the before turning off the device.
abdominal organs at all times with the Organ Protection pieces of foam are needed, count and record how many film, over the wound filler. Remove
 NOTE: When negative pressure is switched off, ensur
         foam pieces are used. any loose transparent film and
abdomen is adequately supported.
in contact with exposed bowel, arteries, veins, organs, or dispose of away from the wound.
     1. Remove and dispose of dressing per institutional
3.     2. Remove the adhesive panel from protocol. Thoroughly inspect the wound to ensure all f
NOTE: Either side of the OPL may be applied to exposed in the wound cavity over the OPL. the Soft Port dressing, and align the pieces have been removed.
organs. The OPL may be cut or folded to accommodate Ensure that foam is sized to fit port opening directly over the hole 2. Count and record number of foam pieces removed.
the specific needs of the patient. loosely into the wound defect in the transparent film.
and there is sufficient material to 3. As with all adhesive products, apply and remove th
1. Remove kit contents from pouch and prepare the OPL top the surface of the abdominal dressing carefully from sensitive or fragile skin to avoid
            wound (do not under fill the Use gentle pressure to anchor the skin stripping – especially if frequent dressing change
ensure that each piece removed has been disposed of wound). Soft Port to t he transparent film. will be needed.
properly, away from the open wound. 4. Dressings should be changed every 48 hours, or m
WARNING: Do not tightly pack or force foam into any frequently, based on continual monitoring of patient
areas of the wound.         
2.     
sediment or infected wounds, more frequent dressing
ing evenly into the abdominal 3. Smooth the dressing down changes may be needed. Check dressings regularly a
cavity, distributing the sides into while removing the Soft Port’s top monitor the wound to check for signs of infection, blee
TRANSPARENT FILM APPLICATION
both of the lateral paracolic gut stabilizationframe.         
ters. Any excess material on the 1. While holding the transparent
1
systemic infection or advancing infection at the wound
sides of the OPL may be folded
1
film, expose one side of the adhe

site, contact the treating clinician immediately.
* s mi
th& ne ph
ew
back onto itself. * s m

R EN
ith &n ep he
A S Y
S ™ w
* s mi
th& ne
R E N A S Y ph ew

S ™
* sm
ith &n ep he
sive backing by removing a single
panel and apply it to the foam.
* sm ith &n ep he R EN
A S Y w
1 1 1 S ™
R EN
A
S
Y S
™ w
* sm ith &n ep
* sm R
h &n
E N A S Y
™ he w
w
4. Secure the Soft Port to the

ith &n ep he Y S
R
E N A S Y
™ w * s m i
S th &n ep he w
R E N A S Y
* sm th &n
i
th &n ep he ™
S
R E N A S YS ™
N A S w
* s
sm i ith &n ep he w
* sm ith R EN
A S Y
™
S
&n ep he w
&n ep h
R E N A S YS ™
N A S Y
2

* m
* sm
m ith &
ith &n
ith
h &n ep he
h &n e
R E
EN
N A
N w
patient according to your

A S YS
™
* sm ith &n
m ith &n e
m ith
it h & n ep
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R EN A
N
n ep he
A S YS ™ w
3. Ensure complete coverage of all 2

2
institutional protocol. Ensure

exposed bowel in the abdominal
the aeration disc, located near
cavity with the OPL, prior to filling
the quick click connector, is not
the wound defect with foam.
covered or otherwise occluded by
the method used to secure the
Soft Port.


Section 11
Appendix IV
EN
NOTE: The High Output Dressing Kit is not compatible with the
RENASYS™ RENASYS GO device.
High Output Dressing Kit  
 
Negative Pressure Wound Therapy
Do not reuse Keep dry
Indications for Use NPWT is appropriate for use on the following wounds: Contraindications
The RENASYS High Output Dressing Kit is intended to be used   The use of NPWT is contraindicated for:
in conjunction with Smith & Nephew Negative Pressure Wound     
Therapy (NPWT) Systems to deliver negative pressure to the wound.         
Smith & Nephew NPWT Systems are indicated for patients who           
would benefit from a suction device, particularly as the device may                  
promote wound healing.    quality of life)
        
  
Warnings              8. When operating, transporting, repairing or disposing of NPWT de
1. Patients must be closely monitored for bleeding. If sudden or blood vessels while under negative pressure.           
increased bleeding is observed, immediately discontinue therapy, 4.              or contamination of the device assembly through incorrect use, can
          5.                   
clinician.        
6. In the event defibrillation is required, disconnect t he NPWT device
2. Patients suffering from diff icult hemostasis or who are receiving from the wound dressing prior to defibrillation. Remove the wound 9.          
         dressing if it will interfere with defibrillation. and weight should be considered when prescribing NPWT devices.
therapy, avoid using hemostatic products that, if disrupted, may 7.              10. NPWT is unsuitable for use in areas where there is danger of
               
3. Sharp edges or bone fragments in a wound m ust be covered or
Precautions needs to be disconnected, t he dressing tubing should be clamped 10. Inspect the overflow protection/bacteria filter on the canister
1.            and the ends of the tubing protected. How long patients may be and replace the canister as necessary. At minimum, the canister
         disconnected from the NPWT device is a clinical decision based    
                    11.        
to be considered would include; amount of drainage, location of          
      the wound, integrity of the dressing seal, assessment of bacterial        
             12. NPWT should not be painful. If the patient reports discomfort,
    5. As a condition of use, the NPWT device should only be used by consider reducing the pressure.
                    
13. Always use the smallest canister volume possible – do not use
delicate fascia.                     
2.            is being used.
14.          
         6.           during therapy to ensure therapeutic treatment and patient comfort.
a wound contact layer or by increasing the frequency of dressing the device must be brought to room tem perature prior to use or the
changes. pumping unit may be damaged. 15. If any liquids penetrate the NPWT device, discontinue use and
       
3. Infected wounds may require more frequent dressing changes. 7.           
                   16. As with all adhesive products apply and remove the dressing
signs of infection.           
8. Position the NPWT device and tubing appropriately to avoid the cially after frequent dressing changes.
4.                        
duration of the treatment. There may be situations when t he patient 17.         
9. When bathing/showering, the patient must clamp off the dressing
          tubing and disconnect from the NPWT device. 18.           
for activities of daily living and diagnostic testing. If the patient a sterile field.
Precautions Specific to the RENASYS High Output Dressing Kit Precautions for Treating Enterocutaneous Fistulae Recommendations Based on Fistula Location and Fluid Descripti on
Pressure Settings Recommendations              The anatomical location of the fistula in the intestine will influence
       top of fistula opening. the amount and type of the output:
                                  
            closely monitored. caustic and heavier the output.
treating physician/clinician and the individual needs of the patient              
     output.
Dressing Application High Output/Thin Consistency Dressing Procedure           
Use aseptic or sterile techniques for application depending on insti- below in accordance with the location and the fluid properties.
Step 4:        Step 6: Place transparent dressing over the
tutional protocol. Use only Smith & Nephew Dressing Kits approved
to fistula opening and in dependent/inferior wound and seal.
for use with the NPWT device.
position.
NOTE: The drain in the High Output Dressing Kit is equipped with
an irrigation port for irrigating the wound surface with an appropriate Caution:    
solution. If the objective is to bathe the wound surface for a period        Step 7:       
of time, the NPWT device should be turned off during that period. point. tape.
When the irrigation port is not in use, the cap should be applied to WARNING: The drain should never be placed
Fistula
the port. directly in the fistula tract. Step 8: Remove the canister tube supplied
Step 1:        Step 5:       with the canister and discard. Attach the
protocol. Thorough wound cleansing should     canister to the RENASYS device.
occur with each dressing change. Step 9:       
Sediment Laden Dressing Procedure ter by joining the blue connector of the drain to
Step 2:       Step 4:        the canister input.
       
to fistula opening and in dependent/inferior
open wound.
    
 PRECAUTION: Ensure dressing tubing clamp is open and there are
Drain     
Step 3:     
position WARNING: The drain should never be placed
       directly in the fistula tract. Step 10:       
    
Step 5:                
CAUTION:                         
moistened with normal saline prior to filling the wound.    pressure setting to the desired level.
Dressing Changes Step 2: As with all adhesive products, apply and remove the dress wounds, more frequent dressing changes may be needed.
PRECAUTION: Before removing the dressing, clamp the dressing            Step 4:         
tubing immediately before turning off the device. especially if frequent dressing changes will be needed. for signs of infection or bleeding. Infected wounds may require
Step 1: Remove and dispose of dressing per institutional protocol. Step 3:          more frequent dressing changes. If there are any signs
            frequently, based on continual monitoring of patient condition. In of systemic infection or advancing infection at the wound
removed. the event of heavy drainage, drainage with sediment or infected site, contact the treating clinician immediately.
70

Appendix V
*smith&nephew
EN
 
RENASYS™       
Drain Accessory Kit  10mm flat wound drain accessory kit       
Negative Pressure Wound Therapy        to sale by or on the order of a physician
 RENASYS Soft Port     
INDICATIONS FOR USE Examples of appropriate wound types include: CONTRAINDICATIONS

The RENASYS dressing kits and related accessories are   The use of NPWT is contraindicated for:
intended to be used in conjunction with Smith & Nephew     
Negative Pressure Wound Therapy (NPWT) Systems. The         
Smith & Nephew RENASYS NPWT Systems are indicated           
for patients who would benefit from a suction device                
(Negative Pressure Wound Therapy) as it may promote    care to enhance quality of life)
wound healing via the removal of fluids including irrigation         
and body fluids, wound exudates and infectious materials.   
WARNINGS AND PRECAUTIONS Y-CONNECTOR AND WOUND BRIDGING PRECAUTIONS check dressings for compressed appearance. If dress
       ings are not visibly compressed, and no leak alarm has
          
(e.g., surgical dehiscence and explored fistula) via t he sounded, a blockage is present.
        
                   
    
risk of cross contamination. tightly sealed, low exuding wounds may present a risk of
USING A Y-CONNECTOR          nuisance blockage alarms from the RENASYS device. If this
                  occurs, replace one drain with a Soft Port.
multiple suction adaptors to one large wound. not recommended due to the risk of cross contamination.            
                         
between them. presents additional demands on the RENASYS device;          
          battery power may deplete more rapidly and/or result in those wounds and their respective seal, a leak alarm from
         additional leak alarms, depending on the extent of the          
            demand on the unit. used, which will offer significantly greater tolerance for
                       
                           
Soft Port with either another Soft Port or a RENASYS drain.         wounds.
          may not be detected by the RENASYS device. Always         
canister change.        
ACCESSORY DRAIN SELECTION 2.                 
RENASYS drains provide a conduit for negative pressure and          margin and be securely anchored to the per iwound area to main
removal of exudate from the wound cavity.    tain a good seal.
          a.                     
ment of wounds in addition to RENASYS Soft Port for experienced
clinicians who wish to enhance the treatment regime of complex around
 drain
(Note: if placingdirectly
  into asinus
   when using multiple pieces of transparent film.
wound shapes and depths, locations, and challenging exudate drain in the tract.)
D APPLY RENASYS SOFT PORT
conditions. 1.          
Warning:          center of the film, over the wound filler. Remove
           to achieve a seal. any loose transparent film and dispose of away
           from the wound.
further improve the removal of exudate from wounds with the b. Apply a strip of ostomy paste
to the wound edge to secure 2. Remove the adhesive backing from
following characteristics:
the drain in position; place the the Soft Port dressing, and align the
   port opening directly over the hole in
    remainder over the top of the
drain and pinch in place.      
  
sure to anchor the Soft Port to the transparent film.
         3.        
tunneling. 3. Smooth the dressing down while removing the
       
RENASYS Soft Port’s frame.
DRAIN APPLICATION WITH RENASYS SOFT PORT over packing the wound.
A CLEAN AND DEBRIDE CAUTION: If using a drain with foam, ensure the drain is placed on 4. Secure the Soft Port to t he patient according to
          top of the foam dressing and not in direct contact with the wound your institutional protocol.
institutional protocol. Thorough wound cleansing should occur with bed. CAUTION: Ensure the aeration disc, located
each dressing change. near the quick click connector, is not covered or
C SEAL THE WOUND otherwise occluded by the method used to secure the Soft Port.
1.        1. While holding the transparent film, expose
        5.            
one side of the adhesive backing by removing a
 
single panel, and apply over the wound.
2. If desired, protect the periwound skin from E INITIATE THERAPY
exposure to moisture and adhesive through the 2.        1.           
use of a skin sealant. removing the remaining adhesive panels to seal,           
     the canister connector. An audible click indicates the connection
3.        is secure.
        3.         2. Activate the RENASYS device and adjust to the prescribed
      therapy level. The recommended therapeutic pressure range is 80
        
Note: Skin sealant and wound contact layer is not included as part 3.          
      4. Secure the drain tubing with waterproof tape. Notes: The vacuum level is a decision each healthcare provider
B PLACE DRAIN AND DRESS WOUND WITH GAUZE Notes: must make, based on an individual assessment of the particular
 Avoid stretching or pulling the transparent film wound. Adhere to the following general guidelines:
1.                           
            The vacuum level should never be painful. If the patient
skin.
channel or round drain. reports discomfort with the vacuum level, it can be reduced.


Section 11
Appendix VI
PICO™ is supplied sterile, single use. Do wound healing via removal of low to moderate
not use if package is open or damaged. levels of exudate and infectious materials.
1. Description Examples of appropriate wound types

include:
Single UseWound
Pressure Negative The PICO
Wound Single System
Therapy Use Negative Pressure
consists of a • Chronic
• Acute
pump and two sterile dressing kits. The
• Traumatic
Therapy System PICO pump maintains negative pressure
• Subacute and dehis ced wounds
wound therapy (NPWT) at 80 mmHg
• Ulcers (such as diabetic or pressure)
surface. Exudate is managed by the
• Flaps and grafts
dressing through a combination of
• Closed surgical incisions
absorption and evaporation of moisture
through the outer film.
PICO Single Use Negative Pressure Wound
Therapy System is suitable for use both in
PICO is intended for use in wound
a hospital and homecare setting.
sizes (surface area x depth) up to 400 
which are considered to be low to

moderately exuding. 3. Contraindications
The use of PICO is contraindicated in the
The kit is intended to be used for a presence of:
maximum of 7 days on low exuding • Patients with malignancy in the wound
wounds and 6 days on moderately exuding bed or margins of the wound (except in
wounds. Therapy duration of the kit may be palliative care to enhance quality of life).
less than indicated if clinical practice or • Previously confirmed and untreated
other factors such as wound type, wound osteomyelitis.
size, rate or volume of exudate, orientation
of the dressing or environmental • Necrotic tissue with eschar present.
conditions, result in more frequent • Exposed arteries, veins, nerves
dressing changes. or organs.
• Anastomotic sites.
2. Indications for use • Emergency airway aspiration.
• Pleural, mediastinal or chest tube
PICO is indicated for patients who would
drainage.
US benefit from a suction device (negative
• Surgical suction.
pressure wound therapy) as it may promote
18504653 35363
• Rest on or pass over a source • Receiving anticoagulant therapy or are not applied over the pad area of
4. Warnings
1. Certain patients are at high risk of of heat. platelet
actively aggregation
bleeding. inhibitors or the dressing as this will impair device
performance.
• Become twisted or trapped under
bleeding complications which, if clothing or bandages so that the • Having weakened or friable blood 7. Where PICO is used on patients with
uncontrolled, could potentially be fatal. negative pressure is blocked. vessels or organs in or around the fragile skin, a skin protectant such as
Patients must be closely monitored for 4. Sharp edges or bone fragments in a wound as a result of, but not limited
bleeding. If sudden or increased wound must be covered or removed to; anastomoses, infection, trauma of skin where fixation strips are to be
bleeding is observed, immediately prior to using PICO due to risk of or radiation. applied. Inappropriate use or repeated
discontinue therapy, leave dressing in puncturing organs or blood vessels • Suffering from difficult wound application of fixation strips may
place, take appropriate measures to while under negative pressure. hemostasis. otherwise result in skin stripping.
stop bleeding and seek immediate 5. In the event that defibrillation is • Untreated for malnutrition. 8. If reddening or sensitisation occurs
medical assistance. required, disconnect the pump from • Noncompliant or combative. discontinue use and contact the
2. The use of anticoagulants does not the dressing prior to defibrillation. • Suffering from wounds in close treating healthcare professional.
deem a patient inappropriate for Remove the dressing if it is positioned proximity to blood vessels or 9.
treatment with PICO however in a location that will interfere with delicate fascia. products such as petrolatum as it
hemostasis must be a chieved before defibrillation. 2. PICO dressings should only be applied may compromise establishing an
applying the dressing. Patients 6. MR Unsafe. PICO is not MRI by a healthcare professional. effective seal.
suffering from difficult hemostasis or compatible. Do not take PICO into the Dressings are not to be removed or 10. The use of negative pressure presents a
who are receiving anticoagulant MRI suite. changed by the patient. risk of tissue ingrowth into foam when
therapy have an increased risk of 7. PICO has not been studied on 3. Where PICO is used on infected wounds, this is used as a wound filler. When
bleeding. During therapy, avoid using pediatric patients. Patient size and more frequent dressing changes may be using foam filler with PICO, tissue
hemostatic products that may increase weight should be considered when required. Regular monitoring of the ingrowth may be reduced by using a
the risk of bleeding, if di srupted. prescribing this therapy. wound should be maintained to check wound contact layer or by increasing
Frequent assessment must be 8. PICO is unsuitable for use in areas for signs of infection. the frequency of dressing changes.
maintained and considered throughout where there is danger of explosion 4. If deemed clinically appropriate, care 11. PICO may be used in conjunction with
the therapy. (e.g. hyperbaric oxygen unit). should be taken that the application of surgical drains provided the dressing is
3. At all times care should be taken to a circumferential dressing does not not placed over tubing where it exits the
ensure that the pump and tubing compromise circulation. skin. Any surgical drain should be routed
does not:
5. Precautions
5. PICO does not contain audible alarms. under the skin away from the edge of the
• Lie in a position where it could cause 1. Precautions should be taken in the The pump should be carried so that it dressing and function independently of
pressure damage to the patient. following types of patients who are at is accessible and the patient/ the PICO Single Use Negative Pressure
• Trail across the floor where it could high risk of bleeding complications: healthcare professional can check the Wound Therapy System.
present a trip hazard or become status routinely. 12. When showering the PICO pump
contaminated. 6. Although PICO can be used under should be disconnected from the
• Present a risk of strangulation or a clothing/ bedding, it is important that dressing. Ensure the end of the tubing
tourniquet to patients. occlusive materials e.g. film dressings, attached to the dressing is facing
72

down so that water does not enter the corrected, contact your caregiver to As a guide: and not extending over the wound to
top of the tube. replace the device. PICO is not intended prevent fluid pooling around the port and
13. Do not take the pump apart. for use aboard aircraft, the batteries Depth – Wounds greater than 0.5cm (1/4 blocking the negative pressure. Remove
14. The dressing should not be used with should be removed during air travel. in.) in depth are likely to require a foam or the other two handles and smooth the
any other suction pump. 22. The potential for electromagnetic gauze NPWT filler to ensure adequate dressing around the wound to prevent
15. Do not alter or cut tubing configuration interference in all environments cannot treatment of all the wound surfaces. creasing. Reposition if required to ensure
or pull on the tubing. be eliminated. Use caution if PICO is Wounds treated with the larger dressing border is not creased.
16. Do not cut the dressing as this may near electronic equipment such as RFID sizes of the PICO system should generally
lead to loss of NPWT application. (Radio Frequency Identification) readers, be no more than 2cm ( 4/5 in.) in depth.
17. Always ensure that the dressing is
positioned centrally over the wound. Exudate – PICO is intended for use on
The port should be positioned 6. Adverse Reactions wounds where the level of exudate is low
uppermost on intact skin and not (nominally 0.6g of liquid exudate/cm2 of
Excessive bleeding is a serious risk
extend over the wound so that the risk wound area/24 hours) to moderate
associated with the application of suction to
of fluid collecting around the port and (nominally 1.1g of liquid exudate/cm2 of
wounds which may result in death or serious
potentially blocking the negative wound area/24 hours). 1g of exudate is 3. Once the dressing is in place, remove
injury. Careful patient selection, in view of the
pressure is minimised. approximately equal to 1ml of exudate. When the pump and the batteries from the
above stated contraindications, warnings and
18. used on a moderately exuding wound, the tray. Insert the batteries. Replace the
precautions is essential. Carefully monitor the
to interfere with some electronic size of the wound should generally be no cover. Following this all three lights
wound and dressing for any evidence of a
medical devices. Where possible, more than 25% of the dressing pad area. should flash once. (Refer to Table 1).
change in the blood loss status of the patient.
4. Join the pump to the dressing by
Notify the healthcare professional of any
scanner range. If the device has been
sudden or abrupt changes in the volume or 7.2. Application twisting together the tubing
connectors. Press the orange button to
the color of exudate. 1. Remove any excess hair to ensure
check that it is functioning correctly start the application of negative
close approximation of the dressing to
following the procedure. pressure. The green light will start to
the wound. If necessary, irrigate the
19. This device is single use only. Use of 7. flash (indicates system working OK,
7.1.Instructions forwound
use wound with sterile saline and pat the
any part of this system on more than Guidance on see Table 1).
wound dry.
one patient may result in cross suitability for management Depending on the size of the wound,
2. Using a clean technique, peel off the
contamination that may lead the pump should take up to 30
to infection.
with PICO central release handle and place the
seconds to establish negative pressure
PICO should be used on wounds which dressing centrally over the wound to
20. High temperatures and humidity may wound therapy.
fit comfortably within the area of the pad, reduce the chance of wound fluid
reduce wear times of dressings. If after 30 seconds the system has not
observing precautions on port positioning coming into contact with the port. The
21. During transport, there is a potential for established negative pressure wound
(on intact skin and not extending over port should be uppermost from the
radio frequency interference that could therapy, the amber air leak light will
the wound). wound (depending on the patient’s
affect PICO performance. If the device illuminate. To troubleshoot refer to
primary position), placed on intact skin
malfunctions, replace batteries. If not section (ii) of Table 1.
7.3. Dressing change 3. Based on dressing change frequency, antimicrobial dressings may be used
1. Dressings should be changed in line a new PICO Single Use Negative under PICO.
with standard wound management Pressure Wound Therapy System kit
will be required dependent on 8. General use
More frequent dressing changes may
be required depending on the level of either when both dressings have been 8.1. Showering and bathing
exudate, condition of the dressing, used or after 7 days when the pump Light showering is permissible; however,
wound type/size, orientation of the automatically stops functioning (all the the pump should be disconnected (see
5. If using SKIN PREP prior to application dressing, environmental considerations lights will turn off at this point). Precautions) and placed in a safe location
of the fixation strips (see Precautions), or other patient considerations; e.g. 4. The dressing should be disposed of as where it will not get wet. The dressing
wipe the area surrounding the when PICO is used on infected wounds. clinical waste. The batteries should be should not be exposed to a direct spray or
dressing and allow skin to dr y. At the healthcare professional’s removed from the pump; and both submerged in water. Ensure the end of the
6. Apply the fixation strips to each of the discretion a PICO dressing may be left batteries and pump disposed of tubing attached to the dressing is facing
four sides of the dressing. Remove top in place for up to 7 days. according to local regulations. down so that water does not enter the top
carrier on the strip after each one has 2. Inspect the dressing regularly. If the 5. For additional information on disposal of the tube.
been applied. These strips maintain dressing appears ready for changing requirements see:
the seal over the wear time of the www.possiblewithpico.com 8.2. Cleaning
dressing. In awkward areas, it may be button and disconnect the dressing from
Adherence to clinical directives concerning
useful to apply the strips to help the pump. The fixation strips should be 7.4. Use with fillers and hygiene is of prime importance. The pump
achieve a seal prior to switching on the stretched away from the skin and the wound contact layers
pump. Place each strip so that it may be wiped clean with a damp cloth
dressing lifted at one corner and peeled
PICO is compatible with standard gauze and using soapy water or a weak disinfectant
overlaps the dressing
approximately 1cm (2/5 border by
in.). Ensure back
Applyuntil it hasdressing
another been fully
asremoved.
per section foam fillers used in traditional NPWT where solution.
tubing is not twisted or trapped 7.2, connect to the pump and press the this is clinically appropriate – for example on
between clothing. orange button to reinitiate t he therapy.
a defect wound. When a filler is used, the 9. Faults and technical
filler and the PICO dressing should be assistance
changed 2 to 3 times a week, according to
local clinical protocol and manufacturer’s If your device develops a fault or there are
instructions. Gauze should loosely fill to the signs of damage, refer to Table 1.
surface of the wound. Avoid over packing.
A B C
(A) Dressing properly positioned and is
acceptable to be left in place adherent layer if required, for example over
Please note that if at any time the f ixation (B) Dressing requires change – Port may a skin graft.
block with fluid On infected wounds or wounds at risk of
strips are removed, the dressing should (C) Dressing requires change – Absorbent
also be replaced. area is full


Section 11
Table 1 – Pump status indication, alarms and faults Section (ii) – Alarms and faults
PICO has visual alarms to let the user know when there is an issue. PICO does not contain Displ ay st at us Ind ic at or st at us Possi bl e c ause Comment s/ troubl e shoot in g
audible alarms. The pump should be carried so that it is accessible and the Amber ‘leak’ Air leak detected Smooth down the dressing and the
patient/healthcare professional can check t he status routinely. light flashes. possibly due to a strips to remove any creases that are
creased dressing/ allowing air into the system.
Section (i) – Normal function border/strip.
Pump is in auto Press the orange button to restart the
pause. NPWT is therapy. The green “OK” light will
Displ ay st at us Ind ic at or st at us Possi bl e c ause Comment s/ troubl e shoot in g not being applied flash as the pump tries to establish
to the wound. therapy.
A l l ig ht s of f. T he pum p is OFF. The therapy has been paused.
Pressing the orange button will The pump will auto If the air leak remains, the amber
restart the therapy and the green pause for 1 hour leak light will start to flash after
light will flash. and then will approximately 30 seconds.
automatically try to If this happens, repeat smoothing
The pump has After 7 days of therapy the pump actions and press the orange button.
reached the end will automatically cease functioning, therapy If the leak is resolved the green light
of its life. in this case all the lights will turn off. if no remedial will continue to flash.
Pressing the orange button will not action is taken.
provide a green flashing light.
Green ‘OK’ System on and Change of batteries required in <24 hours.
The batteries are If the pump has had less than 7 light flashes. functioningproperly. Pause the therapy by pressing the orange
no longer days usage, the batteries may not button.
functional. be functional and should be
replaced as below. Amber ‘battery Battery power low. Push open the battery cover at the top of
low’ light flashes. the pump and remove the old batteries.
All lights This reflects the This is expected. Insert 2 new lithium (L91) batteries.
flash once. pump self test Replace the cover. Press the orange
once batteries
have been inserted green light will flash.
and the cover has Amber ‘leak’ Creased dressing/ Address air leak as above.
been replaced. light flashes. border/strip.
Green ‘OK’ Dressing applied, The pump may be heard running Amber ‘battery Battery power low. Change of batteries or device
light flashes. and full system is occasionally as it maintains the low’ light flashes. required in <24 hours as above.
functioning negative pressure. This is normal. If
properly. this occurs frequently (several times All lights solidly Pump failed. Contact S&N representative.
an hour) smooth down the dressing illuminated.
No issues. to remove any creases that may be System is not Apply new pump and dressing.
allowing air into the system. NPWT is usable.
still being applied in this situation.
10. Specifications 11. Safety and Guidance and manufacturer’s

Maximum Dimensions 85 x 85 x 25mm (3.5 x 3.5 x 1.0”) electromagnetic declaration –
Weight <120g compatibility electromagnetic immunity
Operating Time 7 days When used in accordance with the PICO is intended for use in the
manufacturer’s instructions, PICO electromagnetic environment specified below.
Battery Type Lithium AA (L91)
complies with the general requirements for The healthcare professional or the user of
Power (Battery) 3V DC safety of electrical medical equipment IEC PICO should assure that it is used in such
an environment.
Ingress Protection IPX4
requirements of electrical medical
Maximum Vacuum 100 mmHg for PICO is that the device should not deliver
Mode of Operation Continuous a Negative Pressure to the patient
Patient Protection Type BF

Electromagnetic
compatibility
Storage/Transport 5 – 25°C, 10 – 75% RH
700 to 1060 mbar atmospheric pressure This equipment has been tested and
found to comply with the limits for medical
Operating Environment 5 – 35°C, 10 – 95% RH
700 to 1060 mbar atmospheric pressure
designed to provide reasonable protection
Compliance against electromagnetic interference
typical of medical installations and home
CAN/CSA C22.2 use environment. Portable and mobile RF
communication equipment can affect
Medical Electrical Equipment.
This equipment generates, uses and can

radiate radio frequency energy and if not
installed and used in accordance with the
instructions, may cause harmful interference
to other devices in the vicinity. However,
there is no guarantee that interference will
not occur in a particular installation.
74

Immunity test IEC 60601 test level Compliance level Immunity test Electromagnetic environment – guidelines
Electrostatic discharge (ESD) ±6 kV contact ±8 kV contact Electrostatic discharge (ESD) Floors should be wood, concrete or ceramic tile.
±8 kV air ±25 kV air If floors are covered with synthetic material, the relative humidity
should be at least 30%.
Electric al fast transie nt/burst ±2 kV for power supply li nes Not Applicable
±1 kV for input/output lines
Electric al fast transient/burst Not Applicable
±1 kV line(s) to line(s) Not Applicable
±2 kV line(s) to earth
Not Applicable
Voltage dips, short interruptions <5% UT (>95% dip in U T) for 0.5 cycles Not Applicable
and voltage variations on power 40% UT (60% dip in UT) for 5 cycles
supply input lines Voltage dips, short interruptions Not Applicable
70% UT (30% dip in UT) for 25 cycles and voltage variations on power
<5% UT (>95% dip in U T) for 5 cycles supply input lines
Power frequency (50/60Hz) 3 A/m 50 A/m

Power frequency (50/60Hz) Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
Conducted RF 3 Vrms Not Applicable
150kHz to 80MHz
Conducted RF Not Applicable
Radiated RF 3 V/m 30 V/m
80 MHz to 2.5 GHz 80 MHz to 2.5 GHz
Radiated RF Recommended separation distance
d = 0.175√ P (80 MHz to 800 MHz)
Note 1: At 800 MHz, the separation distance for the higher frequency range applies. d = 0.35√ P (800 MHz to 2.5 GHz)
where P is the maximum output power rating of the transmitter in
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people. watts (W) according to the transmitter manufacturer and ‘d’ is the
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, recommended separation distance in metres (m).
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which PICO is used exceeds 3V/m, PICO should be observed to verify normal operation. If Field strengths from fixed RF transmitters, as
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating PICO. determined by an electromagnetic site survey (a),
should be less than the compliance level in each
WARNING: PICO should not be used adjacent to, or stacked with other electrical equipment and that if adjacent or stacked use
is necessary, PICO should be observed to verify normal operation in the configuration in which it will be used. frequency range. Interference may occur in the
vicinity of equipment marked with the following symbol:
Recommended separation distances between portable and Emissions test Compliance Electromagnetic environment – guidelines
mobile RF communications equipment and PICO
PICO is intended for use in an elec tromagnetic environment in which radiated RF RF emissions CISPR 11 Group 1 PICO uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
disturbances are controlled. The healthcare professional or the user of PICO can help
to cause interference in nearby electronic equipment.
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and PICO as recommended below, RF emissions CISPR 11 Class B
according to the maximum output power of the communications equipment. The RF emissions characteristic of PICO make it
Harmonic emissions IEC Not Applic able
use environments.
Rated maximum output Separation distance according to frequency of transmitter (m)
power of transmitter (W) Voltage fluctuations/flicker Not Applicable
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Not applicable d = 0.175 P d = 0.35 P Covered by or for use under U.S. Pat.
Cautions
0.01 Not applicable 0.02 0.04
7964766, 8080702, D642594, D648353.
This user guide is not intended as a Date of issue 05/2012
0.1 Not applicable 0.06 0.11
1 Not applicable 0.18 0.35
guarantee or warranty. It is intended only
as a guide. For medical questions please
consult a physician.
12. System variants
8 sizes of dressing are available in kits
For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ The product must be used in accordance which contain 2 dressings, 1 pump and
in metres (m) can be esti mated using the equation applicable to the frequency of the transmitter, where P is secondary fixation strips:
the maximum power rating of the transmitter in watts (W) according to the transmitter manufacturer.
with this user guide and all applicable
labelling.
Note 1: At 800 MHz, t he separation distance for the higher frequency range applies. 110cm
0c m xx 3
20cm
0cm // 4in.
4 in. xx 18in.
1¾i n. 66800951
6 68 00 95 2
Note 2: These guidelines may not apply in all situations. Elect romagnetic propagation is affected by absorption PICO is packed in the UK with individual 10cm x 40cm / 4in. x 16in . 66800953
and reflection from structures, objects and people. components made in the following countries: 15cm x 15cm / 6in. x 6in. 66800954
15cm x 20cm / 6in. x 8in. 66800955
15cm x 30cm / 6in. x 11¾in. 66800956
Dressing – UK
20cm x 20cm / 8in. x 8in. 66800957
Guidance and manufacturer’s declaration – Fixation strips – Belgium 25cm x 25cm / 10in. x 10in. 66800958
electromagnetic emissions Pump – China
Batteries – Origin as marked
PICO is intended for use in the electromagnetic environment specified below. Carry bag
The healthcare professional or the user of PICO should assure that it is used in such an The pump may be carried in the patient’s
Smith & Nephew Medical Limited
environment. pocket. Alternatively, a bag for carrying t he
101 Hessle Road, Hull, HU3 2BN England
pump is also available. This can be
™Trade Marks of Smith & Nephew ordered with the following code:
©Smith & Nephew PICO Carry bag 66800918


Section 11
13. Glossary of symbols
Do not use if the package is

Equipment
Isolation Classification:
Type BF applied part opened or damaged
Keep product out of sunlight
Manufacturer Leak alert
International classification Date of manufacture
Product is sterilised by
Keep dry STERILE EO
Ethylene Oxide
LOT Lot Number Battery power indication
EU: Not for general waste OK Pump is functioning properly
25°C/
77°F Caution: Federal (USA) law
Storage temperature
restricts this device to sale by
only or on order of a physician
CE Mark
0086
Start/pause/resume therapy
Attention:
See instructions for use
76

Appendix VII
Frequently asked questions and answers
What is the suction pressure of your machine or the range of pressure that the machine achieves?
RENASYS™ GO, 40mmHg-200mmHg
RENASYS EZ Plus, 40mmHg-200mmHg
PICO™ – operates at continuous negative pressure of nominally 80mmHg
Is the pressure pre-set?
The pressure is not pre-set on the RENASYS EZ Plus or the RENASYS GO. The pressure is pre-set on the PICO
system and it operates at continuous negative pressure of nominally 80mmHg.
Can it be changed?
The pressure setting on the RENASYS devices can be changed. With both pumps, the pressure can be set at
different levels. The device resumes at the same level of pressure as was set when it was last turned off or put
on standby.
The pressure cannot be changed on the PICO system.
Is there an Intermittent feature?
The RENASYS devices have an Intermittent feature. The PICO system does not have an Intermittent feature.
Is there a cut off which stops suction if the canister is full?
The RENASYS canisters are protected by a filter. An audible alarm will sound and a visual light flashes when
the canister is full, but the devices do not turn off. The PICO system is canister-free. The larger the PICO
dressing, the more fluid can be managed. Traditional NPWT may be the best option to manage wound fluid
that is expected to exceed greater than 50cc in 24 hours.
Is there a one-way valve to prevent fluid from coming back through the tubing towards the patient?
The RENASYS and PICO systems have a filter that prevents fluid from coming back through the tubing toward
the patient.
How long does the battery last?
RENASYS GO, 20 hours
RENASYS EZ Plus, 40 hours
The PICO system runs on two AA batteries that can be changed out if required, but should not be necessary. It
is indicated for use up to 7 days, at which time the system is disposable
How much does the machine weight? (How portable is it?)
RENASYS GO is 2.4 lbs, and comes with a shoulder strap and carry bag.
RENASYS EZ Plus is 7.4 lbs, and can be mounted on an IV pole and bed rail attachments.
PICO is less than 4.2 oz, and is small enough to easily fit in a pocket, like a smart phone.
What is the interface with the wound?
For the RENASYS systems, the wound interfaces are foam or AMD gauze. The PICO system employs a
revolutionary dressing technology that manages exudate, eliminating the need for canisters.
How often do you recommend changing the dressing?
We recommend changing foam and/or AMD gauze dressings every 48-72 hours. The PICO system may be left
in place for up to 7 days, depending on level of exudate.


Section 11
Can you “Y” wounds together and if so how many?

Yes, we recommend Y-connecting a maximum of two wounds. PICO™ dressing cannot be Y-connected.
How do you handle undermining?
The RENASYS™-F Foam Dressing and RENASYS-G Gauze Dressing Kits with Soft Port are both indicated
for undermining. We also recommend use of the RENASYS Channel Drain Kit with moistened gauze for
its ability to conform to these types of wounds. The PICO system can be used to handle undermining in
wounds with the addition of either a foam or gauze filler.
How do you handle fistulas?
We offer the RENASYS High Output Dressing Kit that includes a large 28Fr round irrigation aspiration drain.
This kit is indicated for explored fistulas and other high output wounds.
How do you handle exposed tendon or bone?
For the RENASYS systems, we offer a Non-Adherent Gauze in our gauze kits and recommend the use of a
non-adherent with a foam interface to protect exposed tendon or bone while it is under NPWT.
Do you have any special recommendations for high bioburden or infection?
We recommend the use of Smith & Nephew ACTICOAT™ Flex as a wound contact layer for wounds with
a high bioburden or infection. ACTICOAT Flex is compatible for use with gauze or foam NPWT interface
materials. ACTICOAT Flex is also indicated for use with PICO.
78

Appendix VIII
References
1. Chariker ME, Jeter KF, Tintle TE, Bottsford JE. Effective management of incisional and cutaneous fistulae with closed suction wound drainage.
Contemp Surg. 1989:34:59-63.
2. Schultz et al. Wound bed preparation: a systematic approach to wound management. Wound Rep Reg (2003) 11: 1-28.
3. Jeffery LC. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 2 1;9e28.
4. Dorafshar AH, Franczyk M, Lohman R, Gottlieb LJ. 2009. Prospective Randomized Study Comparing Gauze Suction Negative Pressure Wound
Therapy with Standard Vacuum Assisted Closure Device. Abstract presented at American Association Of Plastic Surgeons, 88th Annual
Meeting and Symposium March 21-25, 2009
5. Malmsjö M, Borgquist O. NPWT Settings and Dressing Choices Made Easy. Wounds International 2010; 1(3).
6. Negative Pressure Wound Therapy as a Dressing for Split-Thickness Skin Grafts: Our Experience. O’Brien, et al. Presented at CSAWC San
Antonio Oct 2009.
Additional resources
Afshin Rahmanian-Schwarz et al. A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care. Burns, 2011.
(in press)
Birke-Sorensen H et al. Evidence-based recommendations for negative pressure wound therapy: Treatment variables (pressure levels, wound
filler and contact layer) e Steps towards an international consensus*. Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, S1-S16.
Bondokji S. et al. Clinical efficacy of a new variant of foam-based NWPT system. journal of wound care vol 20 , no 2 , February 2011.
Campbell PE, Smith GS, Smith JM. Retrospective clinical evaluation of gauze-based negative pressure wound therapy. Int. Wound J. 2008
Jun;5(2):280-6.
Chariker ME, Jeter KF, Tintle TE, Bottsford JE. Effective management of incisional and cutaneous fistulae with closed suction wound drainage.
Contemp Surg. 1989:34:59-63.
Dunn RM et al. Assessment of Gauze-Based Negative Pressure Wound Therapy in the Split-Thickness Skin Graft Clinical Pathway—An
Observational Study. www.e-plasty.com, 2011 :116-126.
Dunn R et al. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. International
Journal of Surgery 9 (2011) 258-262.
7(6):448–455.
Hurd T et al. Impact of gauze- based NPWT on the patient and nursing experience in the treatment of challenging wounds. Int Wound J 2010;
Krug et al. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery:
Steps towards an international consensus. Injury – International Journal of the Care of the Injured. 2011; 42, S1-S12.
Llanos S et al. Effectiveness of Negative Pressure Closure in the Integration of Split Thickness Skin Grafts. A Randomized, Double-Masked,
Controlled Trial. Ann Surg 2006;244: 700–705).
Malmsjo M et al. Wound Edge Microvascular Blood Flow Effects of Negative Pressure Wound Therapy Using Gauze or Polyurethane Foam. Ann
Plast Surg 2009;63: 676–681).
Malmsjo M et al. Negative-pressure wound therapy using gauze or open-cell polyurethane foam: Similar early effects on pressure transduction
and tissue contraction in an experimental porcine wound model. Wound Rep Reg (2009) 17 200–205.
Malmsjö M et al. NPWT settings and dressing choices made easy. Volume 1 | Issue 3 | May 2010.
Malmsjö M et al. NPWT in clinical practice made easy. Volume 1 | Issue 5 | Nov 2010.
Vig S et al. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: Steps towards an international
consensus*. Journal of Tissue Viability (2011)


With over 150 years of experience in advanced wound care, Smith & Nephew
is an industry leader providing innovative solutions to meet the needs of chronic,
acute and traumatic wounds across all care settings.
Smith & Nephew, Inc.

USA Customer Care Center Canada Customer Action Centre www.smith-nephew.com
970 Lake Carillon Drive 1-800-876-1261 2280 Argentia Road T 1-800-463-7439 www.myrenasys.com
Suite 110 T 727-392-1261 Mississauga Ontario F 1-800-671-9140 www.possiblewithpico.com
St. Petersburg, FL 33716 F 727-392-6914 L5N 6H8
©2013 Smith & Nephew, Inc., All rights reserved.

™Trademark of Smith & Nephew. Certain trademarks registered in the US Patent & Trademark Office.
RA NPCE 48 0613 N

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5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

NPWT customer care details

These guidelines are recommendations to help clinicians to establish condition-specific treatment

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

General therapy considerations

RENASYS-G Gauze Dressing Kit with Soft Port

RENASYS-F Foam Dressing Kits with Soft Port

5 RENASYS High Output Dressing Kit

RENASYS AB Abdominal Kit with Soft Port

Advanced-complex dressing techniques

PICO™ Single Use Negative Pressure Wound Therapy System

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Negative pressure Wound Therapy (NPWT) is an

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Wound bed preparation

Tissue nonviable Infection Moisture Epidermal margin/

1. Debride wound 2. Optimize healing 3. Know when to stop or change

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Indications for use

Examples of appropriate wound types include:

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

5. In the event defibrillation

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Additional device (pump) specific precautions:

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

2. General therapy considerations

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Choosing a NPWT wound filler/wound interface

Wound size considerations:

Wound bed contour considerations:

Wound bed contour 3

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

The choice of wound filler will be influenced by the amount and

Wound exudate level

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Gauze/foam combination therapy:

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Considerations for pump selection

Optimally the RENASYS EZ Plus is Optimally the RENASYS GO is

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

RENASYS™ portfolio – pumps and canisters

RENASYS EZ Plus RENASYS GO

800mL S-Canister RENASYS GO Large

250mL S-Canister RENASYS GO

Negative Pressure Wound Therapy Clinical Guidelines

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Dressing change frequency

Tips and tricks for improving dressing wear time

NPWT pressure settings

5/23/2018 NPW T RENASYS a nd PICO Clinic a l Guide line s - slide pdf.c om

Recommended pressure settings

Negative Pressure Wound Therapy Clinical Guidelines