SNAP THERAPY SYSTEM Guidelines Jan 2018

SNAP™ THERAPY SYSTEM IN 10 MINUTES:1 TAKE OFF-THE-SHELF. APPLY. GO. The SNAP™ System delivers clinically proven -125mmHg continuous negative pressure while also being wearable. This discreet and silent wearable therapy complements patient activities of daily living and helps support patient quality of life.1 With a simple, pre-set device, disposable negative pressure wound therapy (dNPWT) is easy on the patient for improved compliance.

Single-Use Disposable NPWT Therapy

Discreet with minimal interference with daily living

Suitable For A Range of Wound Types Improved Patient QOL1

SNAP™ System Simple Solution For Home-care Patients

Off-the-Shelf Availability

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Proven in 2 RCT Studies1,2

TABLE OF CONTENTS

Benefits of the SNAP™ System...2 Indications and Contraindications for Use...5 When to Choose SNAP™ System... 7 Precautions and Warnings...9 SNAP™ System Overview... 14 SNAP™ Therapy Cartridge... 15 SNAP™ Advanced Dressings ... 16 SNAP™ System Application and Activation... 18 Resetting/Replacing the SNAP™ Cartridge...26 Cleaning Instructions...29 Troubleshooting...30 Physician Instructions...31 SNAP™ Advanced Dressing Application Tips & Tricks... 33 Appendix Introductory Skills Validation for the Safe Use of the SNAP™ System...42 Clinical Skills Checklist ...44 Ordering Information... 53

These guidelines are not intended as a guarantee of results, outcome, or performance of the SNAP™ System. As with any application, please consult with the patient’s lead clinician about individual conditions and treatments. Follow all applicable manuals and reference guides as to product use and operation. Always consult the product labeling and instructions before applying ACELITY™ products and therapies. Contact your ACELITY representative if you have any questions about operation or use. 3

THE SNAP™ SYSTEM WEARABLE dNPWT Combines the simplicity of advanced wound dressings with the proven efficacy1 of negative pressure therapy in a discreet design. • Mechanically powered and portable for patient mobility • No settings or adjustments for patient to learn • Improved patient QOL to powered NPWT1 • Discreet and worn under clothing • Silent design helps minimise sleep interruptions • Continuous -125mmHg therapy • Single-use, disposable NPWT • Off-the-shelf availability • Indicated for identical wound types as V.A.C.® Therapy

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SNAP™ SYSTEM INDICATIONS AND CONTRAINDICATIONS FOR USE Indications for Use The SNAP™ System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material, and tissue debris. The SNAP™ System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous, or pressure), surgically closed incisions, flaps, and grafts.

Contraindications for Use DO NOT place the SNAP™ System over: • Inadequately drained wounds • Necrotic tissue such as eschar or adherent slough • Exposed blood vessels, anastomotic sites, organs, tendons, or nerves • Wounds containing malignancy • Fistulas • Untreated osteomyelitis • Actively bleeding wounds 5

WOUND CRITERIA/CLINICAL CONSIDERATIONS NPWT ALGORITHM FOR CLINICIANS STOP!

Is the wound type indicated for NPWT use?

NO

Consider use of alternative therapies

YES

• Active Bleeding

• Fistulas

• Malignancy

• Active Infection

• Untreated Osteomyelitis

• Inadequately Drained

• Exposed Organs, Vessels, Tendons, Nerves, Anastomosis Sites

• Necrotic Tissue

Does the wound possess any contraindications for use?

YES

YES

NO

Is the wound < 13cm x 13cm or draining ≤ 180ml/wk of exudate?

STOP!

Consider resolving issues or use alternative therapies

YES

NO 6

WOUND CRITERIA/CLINICAL CONSIDERATIONS

WOUND SIZE < 13cm x 13cm

> 13cm x 13cm

WOUND DRAINAGE ≤ 180ml/week

> 180ml/week

ADDITIONAL CONSIDERATIONS Consider for active, ambulatory, or elderly patients

Wound size or drainage requires the ACTIV.A.C.™ System. Consider the SNAP™ System as wound size and drainage decreases

NPWT INITIATION COVERAGE CRITERIA* New wound; First line treatment; Day 1

Previously treated with modern wound care; > Day 30

These Wound Criteria/Clinical Considerations are provided to help determine when to use the SNAP™ System/ ACTIV.A.C.™ System. They are not intended to replace the judgment and expertise of the treating physician. 7

INDICATED WOUND TYPES ARE IDENTICAL TO V.A.C.® THERAPY THE SNAP™ THERAPY SYSTEM IS INDICATED FOR REMOVAL OF SMALL AMOUNTS OF EXUDATE FROM:

Flap Wounds

Surgically Closed Incisions Subacute and Dehisced Wounds

Traumatic Wounds

Pressure Ulcers

Partial Thickness Burns Grafts Chronic and Acute Wounds Venous Ulcers Diabetic Foot Ulcers 8

Precautions • Patient size and weight should be carefully considered when prescribing the SNAP™ System. • Position the SNAP™ Cartridge and tubing to prevent risk of tripping. Tubing can be cut to fit. • To reduce the transmission risk of bloodborne pathogens, apply standard precautions for infection control with all patients, per institutional protocol. In addition to gloves, use gown and goggles if exposure to body fluids is likely. • The SNAP™ System may not be appropriate for treatment of noncompliant or combative patients. • Patients may shower while using the SNAP™ System. DO NOT allow the SNAP™ System to be submerged. • The SNAP™ Cartridge and SNAP™ Therapy Strap are provided non-sterile and should not be sterilised. • The SNAP™ Cartridge and SNAP™ Advanced Dressings should be stored at room temperature. DO NOT expose to excessive cold or heat.

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Warnings It is a condition of use that the SNAP™ System will be operated under the supervision of a qualified and authorised clinical caregiver and that the user has the necessary training and knowledge of the specific medical application for which the SNAP™ System is being used. Failure to follow these conditions and/or to carefully read and follow all the therapy unit usage and dressing application instructions and the safety information prior to each use may lead to improper device performance and the potential for serious or fatal injury. • The SNAP™ System has not been studied on pediatric patients. • For single patient use only. DO NOT reuse, reprocess or resterilise. Reuse, reprocessing, or resterilisation will compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury or illness. • DO NOT use the SNAP™ Advanced Dressing on patients who are allergic to adhesives. • DO NOT compress contained wound exudate of gelled BIOLOCK™ Technology material when resetting the SNAP™ Cartridge to prevent expulsion of exudate or BIOLOCK™ Technology material. • NEVER leave the SNAP™ Advanced Dressing in place without active negative pressure therapy for more than 24 hours unless under clinical supervision. If the red indicator becomes visible, negative pressure is no longer active. • Fluid and electrolyte loss may result from highly exudative wounds. Close monitoring of electrolytes may be indicated in such cases. • Patients with severe malnutrition may be at higher risk for fluid loss from their wounds and may require more frequent monitoring.

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Bleeding and Infection • Complete haemostasis should be achieved prior to use of the system as bleeding may interfere with the normal function of the SNAP™ System. • Extra care and monitoring is required for patients who are on anticoagulants or platelet-aggregation inhibitors because bleeding may interfere with the normal function of the SNAP™ System. • SNAP™ Advanced Dressing should not be placed on actively infected wounds or bone as this may worsen infections. Infection can be severe and result in septic or toxic shock and/or fatal injury. • Clinicians, caregivers, and patients should frequently monitor the patient’s wound, surrounding tissue, and secreted exudate for signs of infection or other secondary conditions such as maceration or tissue necrosis.

Protect Vessels and Delicate Tissues • Sharp edges, such as bone fragments, should be removed from the wound treatment area prior to placing the SNAP™ Advanced Dressing due to risk of puncturing the SNAP™ Advanced Dressing which will impair the proper function of the SNAP™ System, or could puncture blood vessels, or organs resulting in injury. • DO NOT place the SNAP™ System on the vagus nerve to avoid inducing bradycardia. • DO NOT place the SNAP™ System on friable vessels or infected blood vessels. Infected or weakened vessels are more prone to damage, potentially resulting in bleeding which will interfere with the function of the system. • Care should be exercised if using the SNAP™ System on spinal cord injury patients; stimulus from placement, initiation or cessation of negative pressure may cause autonomic hyperreflexia. • If a patient experiences autonomic dysreflexia, discontinue use of the SNAP™ System and seek medical assistance. 11

Warnings (cont.) Use of SNAP™ Advanced Dressings • Discard if packaging is open or damaged. • DO NOT place the dressing material into blind tunnels. • DO NOT place the primary foam interface in direct contact with delicate structures such as tendons, ligaments, and nerves. Use of a wide-mesh, non-adherent, bio-engineered tissue or natural tissue structures should be utilised to cover and protect delicate structures. • During initial placement of the foam interface, count the total number of pieces placed in the wound and document this number per facility protocol. • During removal of the SNAP™ Advanced Dressing, ensure that all pieces, as documented during initial placement, and any fragments are removed from the wound. Unintentional dressing material retention for longer time periods than recommended may result in infection or other adverse events. • It is recommended that SNAP™ Advanced Dressing is changed at a minimum of two times per week, with frequency adjusted by the clinician as appropriate. • To prevent ischemia, the SNAP™ Advanced Dressing should not be circumferentially placed around appendages, and the SNAP™ Therapy Strap should be worn as loosely as possible. • SNAP™ Advanced Dressing should be removed prior to defibrillation if near the area of pad/paddle placement.

Magnetic Resonance Imaging (MRI) • DO NOT use inside an MRI suite. The SNAP™ Cartridge is not safe for use with magnetic resonance imaging (MRI) equipment.

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Hyperbaric Oxygen Therapy (HBO) • DO NOT take the SNAP™ Cartridge, SNAP™ Therapy Strap, or Tube Fitting into a Hyperbaric Oxygen (HBO) chamber as they have not been studied for use in this environment and could be considered a fire hazard. • After disconnecting the SNAP™ Advanced Dressing tubing from the Tube Fitting, cover the open end of the tubing with cotton gauze. Alternatively, replace the SNAP™ Advanced Dressing with another HBO compatible material during the hyperbaric treatment. • To resume negative pressure therapy after HBO treatment, remove gauze from the tubing, cut 5mm off the tubing end to expose fresh tubing, and reinsert into the Tube Fitting. • To reset the SNAP™ Cartridge, refer to section: Resetting the SNAP™ Therapy Cartridge.

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SNAP™ SYSTEM AT A GLANCE • Wearable, discreet and lightweight dNPWT device (0.1kg) • -125mmHg continuous pressure (-100mHg, -75mmHg also available) • Dressings –– Wound interface layer: Reticulated Open Cell Foam (Blue) –– Sealant layer: Proprietaryhydrocolloid layer with Integrated Tubing Port • Cartridge: Disposable therapy unit integrated with exudate containment unit, 60ml (150ml at -125mmHg also available) • Visual Alarms: Red visual indicator displays when loss of negative pressure is present • Audible Alarms: None

SNAP™ System Wound Criteria: • Location:Non-weight bearing area • Exudate: Low to moderate, thin- to medium-viscosity <20ml/day • Size: 13cm x 13cm (or smaller) • Depth: Approximately 0.5cm - 3.0cm, no minimum depth restriction • Dressing: Minimum customisation required

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SNAP™ CARTRIDGE • Silent, lightweight design is discreet under clothing • Proprietary spring mechanism generates consistent, even levels of pressure • Green visual indicator displays when therapy is active • Red visual indicator displays when cartridge is full or discharged • 60ml fluid capacity with BIOLOCK™ Technology to gel exudate

A A. Activation/reset key B. Chamber window C. Capacity indicator (green) D B

D. Pressure discharge indicator window (red if capacity exhausted) E. Cartridge opening (shown with Tube Fitting attached)

C

E

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SNAP™ SYSTEM DRESSINGS SNAP™ Advanced Dressings (A.) and SNAP™ Bridge Dressing (B.): • Proprietary, thin hydrocolloid dressing offers periwound protection, robust seal, and easy removal • Naturally occurring adhesive, carboxymethyl cellulose (CMC) • No picture-framing of wound required • Cut-to-fit dressing with measured grid for accurate length/ width sizing ––Low-profile, integrated microport for flexibility and tight bending radius for difficult anatomies ––Integrated check-valve prevents reflux of exudate –Tube – Fitting release valve –Cut-to-length – tubing helps reduce trip hazards

E

A

D

C

B

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C. SNAP™ SecurRing™ Hydrocolloid • Fast and easy sealing on uneven skin surfaces and challenging body contours • Reduces accessories needed to seal and protect the wound from moisture • Increases adhesion of the SNAP™ Advanced Dressing on dry and uneven skin D. Reticulated Open Cell Foam Interface (Blue) • Purposefully designed 40-50 PPI (Pores Per Inch) open cells to evenly distribute -125mmHg pressure across the wound bed • Facilitates the lifting and channeling of exudate and infectious materials away from the wound bed and into the canister E. S NAP™ Therapy Strap and SNAP PLUS™ Therapy Strap (each available in three sizes) • Clip (60ml Cartridge) or Pouch (150ml Cartridge)

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SNAP™ SYSTEM APPLICATION & ACTIVATION All wounds are unique. The treating clinician should make an individual assessment of the optimal dressing and application method. Inspect all packaging before use and DO NOT use products from packages that are open or damaged.

You will need the following dressing items: 1. Reticulated Open Cell Foam Interface (blue) 2. SNAP™ Hydrocolloid Dressing

Optional items: 1. SNAP™ SecurRing™ Hydrocolloid 2. Non adherent dressing such as ADAPTIC TOUCH™ Non-Adhering Silicone Dressing

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SNAP™ ADVANCED DRESSING BASIC APPLICATION STEPS For SNAP™ Advanced Dressing advanced application please see the Tips and Tricks section on pg. 33

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Step One Prepare the wound bed and periwound skin per institutional protocol and irrigate wound bed thoroughly with normal saline.

2

Step Two If necessary, apply a skin protectant to the surrounding skin and allow to dry.

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Step Three If necessary, cut a single layer of widemesh, non-adherent dressing to the size of the wound and place on the wound bed.

4

Step Four Cut the foam interface to fit the size and shape of the wound.

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Application Steps (cont.)

TIPS: • DO NOT cut foam directly over wound bed to avoid loose fragments from falling into wound • Brush off foam edges after cutting to remove any loose fragments

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Step Five Place foam interface into wound cavity. Foam interface should fill the wound cavity and extend above the wound margins. DO NOT over pack.

TIPS: • Count and record the number of pieces of foam interface used to ensure the same number of pieces are removed during dressing change. • DO NOT place foam into blind or unexplored tunnels. If a piece of foam is used in a tunnel, ensure the foam is visible and in contact with foam in the primary wound bed.

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