Smith & Nephew

RENASYS EZ PLUS and GO Information Guide Oct 2011

Information Guide

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Information Guide

RENASYS™ GO RENASYS™ EZ Plus information GUIDE CONTENTS 1

Introduction

RENASYS GO

RENASYS EZ Plus

Dressing kits and consumables

Cleaning instructions

Support and educational material

Case studies / clinical papers

Ordering information

Latest information / Product updates

™Trademark of Smith & Nephew ®TMTrademarks Acknowledged

SN8886 (10/11)

Introduction Negative Pressure Wound Therapy (NPWT) refers to the use of negative pressure to promote healing in acute and chronic wounds. The therapeutic benefits of NPWT include the reduction in bacterial load, an increase in blood flow to the wound and stimulation of granulation tissue formation.1,2,3

The principles of Negative Pressure Wound Therapy NPWT delivers vacuum-assisted pressure below the wound surface to help promote healing. NPWT consists of a wound filler (foam or gauze), a drainage tube inserted into the dressing, and a transparent film to seal the site before being connected to a suction device.

Indications for Negative Pressure Wound Therapy (NPWT) NPWT is suitable for a range of wound types including pressure ulcers, diabetic/ neuropathic ulcers, venous insufficiency ulcers, and traumatic wounds, post operative and dehisced surgical incisions, explored fistulas, skin grafts and flaps.

With the RENASYS range of devices and accessories, Smith & Nephew provide a quality offering to facilitate NPWT supported by a 24 hour emergency telephone line, credible and indication-specific clinical information and easy to understand patient guides.

References 1. Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004; 114(5):1086-96; discussion 1097-8. 2. Wackenfors A, Sjögren J, Gustafsson R, Algotsson L, Ingemansson R, Malmsjö M. Effects of vacuum-assisted closure therapy on inguinal wound edge microvascular blood flow. Wound Repair Regen. 2004; 12(6):600-6. 3. Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. 2005 Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 366(9498):1704-10.

RENASYS™ GO Introducing RENASYS GO RENASYS GO combines sleek design and quiet operation for added comfort and peace of mind. Patients can continue treatment at home with more mobility than ever before. The RENASYS GO device will provide the following: • Stylised design, small and light weight • Improved alarm options and functionality • Compact size allowing excellent portability for the patient • Integrated and subtle (frosted) canister • Patient lock out function for extra protection • Easy to use operating controls • Quiet operation, helping patients to live with their treatment

Features of the renasys GO device

Highly Confidential – for internal use only

A L A R MS The alarms that have now been incorporated into this device are:

2 RENASYS GO device information Pressure settings RENASYS GO pressure ranges from -40mmHg to -200mmHg, providing both continuous and intermittent therapy; with a toggle selector switch on the front fascia.

Canisters Two integrated canister sizes are available for the RENASYS GO depending on requirements: • 300 ml canister • 750 ml canister

Protecting your patient Range of safety alarms when: • Low battery • Canister full • Full canister/ line blockage • Low vacuum • Extremely low battery In addition, there is a lock function to avoid patient changes to pressure settings.

Portability • Lightweight, only 1.2kgs which can be easily carried with a shoulder strap • Compact size (210mm x 175mm x 85mm) • Removable cover protecting the patient’s dignity

Quiet device • Low noise levels enable patients to relax • Discreet treatment increases patient confidence and compliance

2 RENASYS GO Specifications

Description

RENASYS GO

Size HxWxD (mm)

210 x 175 x 85

Weight (kg)

1.2 without the bag

Vacuum Range (mm Hg)

40 to 200; cont. and inter. therapy

Battery Life (hrs)

Recharge Time (hrs)

Waste Canister

300ml, 750ml integral

Display

Digital

Patient lock out

Yes

IV Pole attachment

Via Strap

Bed attachment

Via Strap

Carry bag

Yes

2 RENASYS GO Technical Specifications REQUIREMENT

SPECIFICATION

NOTES

Portable

Yes

Provided with a carry bag. Strap can be used to attach to IV pole or foot of bed

Pressure Range

-40 to -200mmHg

40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, 170, 180, 200mmHg

Free Air displacement of pump

4 L/Min.

Equivalent performance to other available styles

Battery Life

Approximately 20hrs

Battery life is dependent on amount of exudate and wound volume.

Available Cycles

Continuous or Intermittent

Displays

Digital

Displays information on the pressure setting, the mode of operation and information about any alarm which is active at the time.

Status LED

The main LED at the top of the device is the first place to look to check if everything is OK. If it is not illuminated the device is either switched off or in standby mode. If the LED is green then therapy is being applied in a controlled manner. If this LED is amber, an alarm is active and the nature of the alarm can be found on the LCD screen.

Other LEDs

There are also LEDs to show the battery charge status and to indicate if the alarm mute or keypad locks are active.

Auto Lockout

Yes

Display locks out after 10 minutes

Canister sizes

300ml or 750ml

Sealed opaque integral bacterial filter

Solidifier with canister

Yes

Canister markings

Yes

Antibacterial Filter

Yes

Low battery alarm

Yes

Low vacuum alarm

Yes

If the vacuum is 15mmHg below the set point for more than 2 minutes this alarm will activate

High vacuum alarm

Yes

If the vacuum is 15mmHg above the set point for more than 2 minutes this alarm will activate

Full canister alarm

Yes

Line blockage alarm

Yes

Inactive pump alarm

Alarm Mute Button

Yes

To silence alarm for 2 minutes while problem is rectified.

Tubing clamps

Yes

Bespoke tubing connector with isolating plug/ cap to connector

Mains power option

Yes

Power Input

Internal Battery or 110240 VAC

300ml canister – 50, 100, 200, 300ml 750ml canister – 150, 300, 450, 600, 750ml) level markers which can be used when the device is hung in the vertical orientation.

RENASYS™ EZ PLUS Introducing RENASYS EZ PLUS RENASYS EZ PLUS allows the flexibility to treat multiple types of patients with a device that is easy to use and has the capacity and power to cope under pressure. RENASYS EZ PLUS is indicated for a variety of surgical, traumatic and chronic wounds.

Features of the renasys ez PLUS device

Handle

Antibacterial filter Pressure indicator

Canister holder

Pressure selector

Canister Lock/unlock

Functionality LEDs

On/off Continuous/intermittent

HighlyConfidential Confidential––for forinternal internaluse useonly only Highly

Highly Confidential – for internal use only

Poweron on Power Indicator BatteryIndicator Battery HighVacuum VacuumAlarm Alarm High Power on Power on LeakAlarm Alarm Leak Battery Battery Indicator LowVacuum VacuumAlarm Alarm Low High Vacuum AlarmAlarm High Vacuum Alarm Full Canister/Blockage Alarm Full Canister/Blockage Leak LeakAlarm Alarm

LowVacuum VacuumAlarm Alarm Low Full FullCanister/Blockage Canister/Blockage Alarm Audio Pausebutton button Alarm Audio Pause

Audio Pause button Audio Pause button

Attachingto toan anIVIVpole pole Attaching

Attachingto toaabed bedrail rail Attaching

Attaching to an IV pole

Attaching to a bed rail

Attaching to an IV pole

Attaching to a bed rail

800mlCanister Canister 800ml

250mlCanister Canister 250ml

800ml Canister

250ml Canister

800ml Canister

250ml Canister

3 RENASYS EZ PLUS device information Pressure Settings RENASYS EZ PLUS pressure ranges from -40mmHg to -200mmHg, providing both continuous and intermittent therapy; with a toggle selector switch on the front fascia.

Canisters Selection of two canister sizes is available for the RENASYS EZ PLUS depending on requirements. • 250 ml canister • 750 ml canister

Attachments to make you life easier • No special docking station needed as the device easily attaches to a bed, wheelchair or IV pole. • Tilting does not affect performance of pump

Flexibility • A powerful device with high flow rate that performs under pressure • Two canister sizes give you the capacity to deal with a wide range of exudate levels

Quiet device • Low noise levels enable patients to relax • Discreet treatment increases patient confidence and compliance

3 RENASYS EZ PLUS Specifications

Description

RENASYS EZ PLUS

Size HxWxD (mm)

361 x 240 x 170

Weight (kgs)

3.7

Vacuum Range (mm Hg)

40 to 200; cont. and inter. therapy

Battery Life (hrs)

Recharge Time (hrs)

Waste Canister

250ml and 800ml

Display

Analogue

Patient lock out

Yes

IV Pole attachment

New design – Integrated system

Bed attachment

New design – Integral hooks

Carry bag

Smith & Nephew Bag

3 RENASYS EZ PLUS Technical Specifications REQUIREMENT

SPECIFICATION

NOTES

Portable

Can be carried but should remain static if possible.

Integral hook for bed mounting and clamp to permit IV pole attachment.

Pressure range

-40 to -200mmHg

12 possible preset values (40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200mmHg)

Free air displacement

9 litres per min.

Battery life

Approximately 40 hrs

Available cycles

Continuous or Intermittent

Display

Analogue display

Simple and intuitive controls mean fewer troubleshooting problems.

Lockout

Yes

Prevents patient tampering with pressure controls.

Canister size

250ml or 800ml

Sealed opaque with solidifier. Choice of two options

Solidifier with canister

Yes

Canister markings

Yes

Antibacterial Filter

Yes

Low battery alarm

Yes

Green Amber LED indications plus audible alarm

Low vacuum alarm

Yes

If the vacuum is 15mmHg below the set point an Amber LED indications plus audible alarm will activate.

Full canister alarm

Yes

Amber LED indications plus audible alarm.

High vacuum alarm

Yes

If the vacuum is greater than 235mmHg an Amber LED indications plus audible alarm will activate. The device will stop delivering therapy

Line blockage alarm

Yes

Amber LED indications plus audible alarm.

Excessive leak alarm

Yes

Amber LED indications plus audible alarm.

Inactive pump alarm

Alarm mute button

Yes

To silence alarm for two minutes while the problem is rectified, button illuminates during activations.

Tubing clamps

Yes

Bespoke tubing connectors with integral sealing plug/cap to connector

Carrying bag

Smith & Nephew Bag

Mains power option

Yes

Power input

Internal Battery or 100-240 VAC

Battery life is dependent on amount of exudate and wound volume.

250ml canister – 10ml increments 800ml canister – 100ml increments.

Dressing kits and consumables RENASYS-G (Kit components)

(Kit components)

all

Gauze kit contents Medium

Kits Large Small

00216 - Round 00217 - Flat

66800218 - Channel 66800219 - Flat

66800220 - Round 66800491 –Flat Round 66800221-

or 10fr

Flat or channel

Flat or 19fr

in x 3in (7cm x 7cm)

1 – 3in x 8in (7cm x 20cm)

ackage 4 x 4s

1 – package Kerlix fluff 6 x 6s

4in x 4.75in m x 12cm) sheets

gauze 2 –Non-adherent 6in x 8in (15cm x 20cm) sheets

1 each

let

1 bullet

2 bullets

cket

1 packet

2 packets

1 strip

2 – 4in x 4.75in 1(10cm strip x 12cm) sheets

1 each

ips

Connective tubing 2 strips

41 each strips

1 each 4 strips

1 each4 strips

y used – tiny wounds mple: 5.0 x 5.0 x 1.5 cm m³ or smaller.

Small to moderate wounds with moderate depth Saline bullet Example: 8cm x 8cm x 2.5cm - 160 cm³ Most common kit sold.

Large surface area or full thickness wounds with 1 bullet significant depth Example: 10cm x 10cm x 5.0cm - 500 cm³

1 packet

Xtra large surface area or Same example as wound full thickness wounds with size for the XL kit. High 1 bullet 2 bullets Output wounds and/or with significant depth. Example: 18cm x 18cm x sediment. Indicated for fistulas and large abdominal 6.5cm - 2106 cm³ 1 packet 2 packets wounds.

Strip paste

1 strip

Wound ruler

1 each

Waterproof tape

2 strips

4 strips

** The examples are just guidelines. They will not be exact for all wounds.

Small wounds. Example: 5.0 x 5.0 x 1.5 cm 38 cm³ or smaller.

Small to moderate wounds with moderate depth. Example: 8cm x 8cm x 2.5cm - 160 cm³ Most common kit sold.

Extra large surface area or full thickness wounds with significant depth. Example: 18cm x 18cm x 6.5cm - 2106 cm³

Product codes

Drain

Antimicrobial gauze

Transparent film

Skin-PREP™

3 – 3in x 8in (7cm x 20cm)

X-Large Medium

Wooding - Scott X-large

66800222 - Round

66800493 – Channel 66800494 – Flat

66800212

66800497 – Round

19 fr

Irrigation aspiration

3 – 3in x 8in (7cm x 20cm)

2 – Kerlix roll

Flat or 10fr

Flat or channel

19 fr

1 – 3in x 3in 2 – 8in x 12in (7cm x 7cm)

1 – 3in x 8in 2 – 8in x 12in (7cm x 20cm)

3 – 3in x 8in 2 – 8in x 12in (7cm x 20cm)

1 each

1 – package 1 each Kerlix fluff 6 x 6s

2 – Kerlix roll

1 – Kerlix roll

(20cm x 30cm) sheets

1 – package 4 x 4s

(20cm x 30cm) sheets

(20cm x 30cm) sheets 1 each

2 bullets

2 packets

2 – 6in x 8in (15cm x 20cm) sheets 1 strip

2 bullets 3 packets

2 – 8in x 12in (20cm1xstrip 30cm) sheets

4 RENASYS-F/P Foam Port (Kit components)

Kit contents

Kits Small

Medium

Large

Product codes

66800639

66800640

66800641

Foam dimensions

10cm x 8cm x 3cm

20cm x 12.5cm x 3cm

25cm x 15cm x 3cm

Port

1 x Port Connector

Drape

8in x 12in (20cm x 30cm)

Number of drapes per pack

Tube fixation film

2 per kit

Ifu

In kit

Case size

4 NPWT wound sealing kits The Smith & Nephew Negative Pressure Wound Therapy (NPWT) sealing kits contain the necessary components to successfully prepare a wound for NPWT using the RENASYS™ EZ or RENASYS GO NPWT system. The type of wound sealing kit required depends on the size and depth of the wound and the drainage requirements.

Drain guide (gauze kits only) Flat

Multipurpose, standard drain for deep or shallow wounds where low or heavy drainage is required. No sediment present.

Round

10 French – For shallow wounds where minimal or no drainage is required. No sediment present. 19 French – For deeper wounds (at least 1cm of depth) where moderate to heavy drainage is required. No sediment present.

Channel For medium depth wounds where nil to moderate drainage is required. The channel can be inserted into tunnels and curled into undermining space.

Kit name

Description Multipurpose standard drain

Medium flat drain

Deep or shallow wounds Minimal to heavy drainage without sediment

Channel drain

Non-hollow, non-perforated design Minimal to moderate drainage Can be inserted into tunnels and curled into undermining space

Small round drain

May be curled into the wound bed or used in a linear fashion 10 fr: Shallow wounds with minimal to moderate drainage

Extra large round drain

May be curled into the wound bed or used in a linear fashion 19 fr: heavy to moderate drainage with no sediment and at least 1cm of depth

4 Wound sealing selection guide

Wound size

Up to 15cm x 10cm

Up to 30cm x 20cm

Drainage

Dressing selection

Low

Medium Kit with flat drain Medium Kit with channel drain

Moderate to heavy

Medium Kit with flat drain Medium Kit with channel drain

Medium

Large Kit with flat drain

Sediment present

Medium Kit with channel drain

Low to heavy

X-Large Kit with round drain

Sediment present

Large or X-Large with round drain

RENASYS™ Cleaning and disinfecting instructions The instructions supplied with all cleaning agents must be followed. Canister Kits are not reusable. A new disposable canister kit must be used for each patient. Disconnect the unit from the power socket before cleaning is commenced. Use a highlevel disinfection solution or wipe as described in your local equipment decontamination protocol. While cleaning, always wear the appropriate protective equipment as described in your local protocol for handling clinical waste. As a minimum, gloves should be worn throughout this process.

Please ensure wound vacuum systems have been cleaned and disinfected before returning to Smith & Nephew 1. As directed in your local protocol for the handling and disposal of biological contaminated equipment, remove the canister and discard it. 2. Carefully wipe all surfaces of the device with the disposable wipe. Particular attention should be made to the handle (RENASYS EZ) and areas close to the canister connection port. 3. Carefully wipe all surfaces of the power cord and power adaptor (RENASYS GO). 4. Use second wipe with the disinfectant solution to thoroughly clean all external surfaces. 5. Allow to air dry (do NOT dry with towel / cloth. PLEASE NOTE: RENASYS GO carry straps should be replaced with each new patient usage.

Support and educational material RENASYS™ -G Quick reference dressing guidelines

RENASYS-G Quick reference dressing guidelines

1. Clean wound bed with normal saline if indicated

2. Apply skin protection wipe to periwound skin

3. Cut a single layer of non-adherent wound contact layer to fit the wound dimensions

4. Lay non-adherent wound contact layer into wound bed

5. Moisten gauze with saline saline and squeeze out excess

6. Place a layer of moistened gauze into wound bed

7. If required, cut drain to fit wound dimensions. As a guide the drain should be at least 1–2cm shorter than the wound size

8. Secure drain using strip paste beneath and on top of drain as shown

9. Fill remaining defect to skin level with additional moistened gauze

10. Cover wound and drain with drape with approx 3–5cm overlap onto surrounding skin

11. Attach canister to the device, secure dressing tubing to the canister tubing

12. Ensure tubing clamps are open

NPWT 24hr Helpline UK: 0845 1200 167 Ireland: 01217 0484 13. Turn on machine. Set desired negative pressure and start therapy

14. Dressing should collapse and appear firm to touch and have a ‘raisin-like’ appearance

6 RENASYS-G Quick reference dressing guidelines RENASYS™ -G specialist dressing techniques Undermining

Option 1 – Follow instructions overleaf making sure that all undermined areas are filled with saline moistened gauze. The drain should also be inserted as described overleaf.

Option 2 – Wrap your selected drain in moistened gauze and coil into the wound. Fill remaining defect with saline moistened gauze, secure drain with strip paste and seal with drape

Tunnelled wounds

Option 1 – When the tunnel is only slightly larger than the drain circumference – insert channel drain directly into the tunnel until resistance is felt and then draw back at least 1cm to prevent excess pressure at the wound base. Coil the remaining drain into the wound bed then fill the defect with saline moistened gauze, secure drain with strip paste and seal with drape

Option 2 – When the tunnel is larger than the drain circumference, wrap your chosen drain in saline moistened gauze, insert into the tunnel until resistance is felt and then draw back at least 1cm to prevent excess pressure at the wound base. Coil the remaining drain into the wound bed then fill the defect with saline moistened gauze, secure drain with strip paste, and seal with drape

Bridging technique

Option 1 – Treating two wounds in close proximity with one pump – fill both wounds with saline moistened gauze, protect intact skin between the wounds with drape then connect both wounds with a strip of gauze, place drain between the wounds on the strip of gauze connecting the two wounds, secure the drain with strip paste, seal all wounds and the drain with drape

Option 2 – Where only one wound is present this technique can be used to move the drain tubing from wound’s periphery to a non-weight bearing area. Fill the wound defect with gauze, apply drape onto the skin to create a protective bridge between the wound and the upper body surface. Run a strip of gauze on top of the drape in a continuous strip from the wound to the non-weight bearing surface. Secure the drain with strip paste, cover the wound and all gauze and the drain with drape

Skin grafts

Skin flaps

Cover graft with non-adherent wound contact layer extending at least 1cm beyond the suture/staple line, place a single layer of moistened wound filler over the prepared area, then place a flat drain as close to the middle of the wound as possible. Cut to fit the wound dimensions if required. Place a single layer of moistened wound filler over the drain and seal

Cover the intact skin of the flap with transparent film to within approximately 1cm of the suture line. Cover the opposite side of the suture line with transparent film to within approximately 1cm of the suture line (creating a ‘ring’ of exposed skin around the suture line). Cover this with nonadherent wound contact layer. Then place a single layer of moistened wound filler over the prepared area, place a flat drain as close to the middle of the wound as possible. Cut to fit the wound dimensions if required. Place a single layer of moistened wound filler over the drain and seal

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6 RENASYS-F/P Foam Quick reference dressing techniques RENASYS–F/P Quick Reference Dressing Guide

Layered technique 1

Debride any necrotic tissue / eschar if necessary. Cleanse the wound bed and pat dry as per protocol.

Apply SKIN-PREP™ or a thin hydrocolloid to the peri-wound skin if required. N.B. Skin sealant is not included as part of the RENASYSF/P foam dressing kit.

Cut the foam to fit the size and shape of the wound. Do not cut the foam directly over the wound bed.

Place the foam into the wound cavity. Multiple pieces or layers of foam can be inserted into a cavity if required to ensure a perfect fit is achieved.

Cover the foam with transparent film. The film should extend 5cm beyond the wound margin to facilitate an adequate seal.

Ensure the film is securely anchored to the peri-wound area to maintain a good seal. Ensure the film is not stretched or applied under tension, or pressure applied to the foam as this may cause blistering when the NPWT is applied

Cut a small circular hole in the centre of the film over the foam. The hole needs to be roughly 0.6cm in size. Remove any excess trimmed film.

Remove the backing from the Port dressing.

Align the opening of the Port over the hole in the film. Use gentle pressure to anchor the Port to the film.

Smooth the dressing down whilst removing the frame.

Connect the Port tubing to the canister tubing. Ensure the tubing clamps are open.

Switch on the device, set desired therapy setting and start therapy

The finished dressing should collapse, be firm to the touch and have a wrinkled appearance.

Healthcare Divison Smith & Nephew Pty Ltd 315 Ferntree Gully Road PO Box 242 Mount Waverley 3149 Victoria Australia

T 61 3 8540 6777 F 61 3 9544 5086 www.smith-nephew.com.au/healthcare NPWT Customer Service T 1800 068 840 F 1800 671 000

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