Information Guide - Smith & Nephew - Corporate

1 Information Guide 1 Introduction2 RENASYS GO 3 RENASYS EZ PluS 4 Dressing kits and consumables5 Cleaning instructions6 Support and educational material 7 Case studies / clinical papers 8 Ordering information9 latest Information / Product updates RENASYS GORENASYS EZ PluS Information GUiDECONTENTS Trademark of Smith & Nephew SN8886 (10/11) TMTrademarks AcknowledgedIntroduction1 Negative Pressure Wound Therapy (NPWT) refers to the use of negative pressure to promote healing in acute and chronic therapeutic benefits of NPWT include the reduction in bacterial load, an increase in blood flow to the wound and stimulation of granulation tissue ,2,3the principles of negative Pressure Wound therapyNPWT 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 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 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.

2 References1. 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 Wackenfors A, Sj gren J, Gustafsson R, Algotsson l, Ingemansson R, Malmsj M. Effects of vacuum-assisted closure therapy on inguinal wound edge microvascular blood flow. Wound Repair Regen. 2004; 12(6) 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) GO2 Introducing RENASYS GORENASYS 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 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 treatmentfeatures of the rEnasys Go deviceHighly Confidential for internal use only ALARMS The alarms that have now been incorporated into this device are.

3 -Low Battery Alarm (Battery symbol indication) -Extremely low battery (Battery symbol indication) -Canister full (Text on the screen + audible sound) -Line blockage alarm (Text on the screen + audible sound) -Low Vacuum (Text on the screen + audible sound) -High Vacuum (Text on the screen + audible sound) There are detailed instructions of the various features of this device in the draft IFU that is enclosed at the end of this section in the launch pack. This gives detailed descriptions of the warning messages and how to rectify them if this occurs. The strap can be used to attach the device to and IV Pole/Bed and wheelchair. In-situ shots are available within the RENASYS Toolkit. Features, advantages and benefits Feature: New, more portable design, smaller & light weight Advantage: user friendly design for the patient Benefit: Improved quality of life for the patient and hopefully better compliance Feature: Improved alarm functionality Advantage: Troubleshooting of the device will be easier 2 RENASYS GO device informationPressure settingsRENASYS GO pressure ranges from -40mmHg to -200mmHg, providing both continuous and intermittent therapy.

4 With a toggle selector switch on the front integrated canister sizes are available for the RENASYS GO depending on requirements: 300 ml canister 750 ml canisterProtecting your patientRange of safety alarms when: low battery Canister full Full canister/ line blockage low vacuum Extremely low batteryIn addition, there is a lock function to avoid patient changes to pressure lightweight, only which can be easily carried with a shoulder strap Compact size (210mm x 175mm x 85mm) Removable cover protecting the patient s dignityQuiet device low noise levels enable patients to relax Discreet treatment increases patient confidence and compliance 2 RENASYS GO Specifications DescriptionrEnasys Gosize HxWxD (mm)210 x 175 x 85 Weight (kg) without the bagVacuum range (mm Hg)40 to 200; cont. and inter. therapyBattery Life (hrs)20recharge time (hrs)4 Waste Canister300ml, 750ml integralDisplayDigitalPatient lock outYesiV Pole attachmentVia StrapBed attachmentVia StrapCarry bagYes2rEQUirEmEntsPECifiCationnotEsPort ableYesProvided with a carry bag.

5 Strap can be used to attach to IV pole or foot of bedPressure Range-40 to -200mmHg40, 50, 60, 70, 80, 90, 100, 120, 130, 140, 150, 160, 170, 180, 200mmHgFree Air displacement of pump4 performance to other available stylesBattery lifeApproximately 20hrsBattery life is dependent on amount of exudate and wound CyclesContinuous or IntermittentDisplaysDigitalDisplays Information on the pressure setting, the mode of operation and Information about any alarm which is active at the lEDThe 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 lEDsThere are also lEDs to show the battery charge status and to indicate if the alarm mute or keypad locks are lockoutYesDisplay locks out after 10 minutesCanister sizes300ml or 750mlSealed opaque integral bacterial filterSolidifier with canisterYesCanister markingsYes300ml canister 50, 100, 200, 300ml 750ml canister 150, 300, 450, 600, 750ml)

6 Level markers which can be used when the device is hung in the vertical FilterYeslow battery alarmYeslow vacuum alarmYesIf the vacuum is 15mmHg below the set point for more than 2 minutes this alarm will activateHigh vacuum alarmYesIf the vacuum is 15mmHg above the set point for more than 2 minutes this alarm will activateFull canister alarmYesline blockage alarmYesInactive pump alarmNoAlarm Mute ButtonYesTo silence alarm for 2 minutes while problem is clampsYesBespoke tubing connector with isolating plug/cap to connectorMains power optionYes Power InputInternal Battery or 110-240 VACRENASYS GO Technical Specifications3 Introducing RENASYS EZ PluSRENASYS 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 EZ PluS is indicated for a variety of surgical, traumatic and chronic of the rEnasys Ez PLUs devicePressure indicatorPressure selectorlock/unlockOn/offContinuous/inte rmittentHandleAntibacterial filterCanister holderCanisterFunctionality lEDsRENASYS EZ PluSAttaching to a bed rail3 Highly Confidential for internal use only Attaching to an IV pole Attaching to a bed rail 800ml Canister 250ml Canister Power on Battery Indicator High Vacuum Alarm Leak Alarm Low Vacuum Alarm Full Canister/Blockage Alarm Audio Pause button Power onBattery IndicatorHigh Vacuum Alarmleak Alarmlow Vacuum AlarmFull Canister/Blockage AlarmAudio Pause buttonHighly Confidential for internal use only Attaching to an IV pole Attaching to a bed rail 800ml Canister 250ml Canister Power on Battery Indicator High Vacuum Alarm Leak Alarm Low Vacuum Alarm Full Canister/Blockage Alarm Audio Pause button Highly Confidential for internal use only Attaching to an IV pole Attaching to a bed rail 800ml Canister 250ml Canister Power on

7 Battery Indicator High Vacuum Alarm Leak Alarm Low Vacuum Alarm Full Canister/Blockage Alarm Audio Pause button Attaching to an IV pole800ml Canister250ml Canister3 RENASYS EZ PluS device informationPressure settingsRENASYS EZ PluS pressure ranges from -40mmHg to -200mmHg, providing both continuous and intermittent therapy; with a toggle selector switch on the front of two canister sizes is available for the RENASYS EZ PluS depending on requirements. 250 ml canister 750 ml canisterProtecting your patientRange of safety alarms when: low battery Canister full Full canister/ line blockage low vacuum Extremely low batteryIn addition, there is a lock function to avoid patient changes to pressure 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 pumpflexibility 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 levelsQuiet device low noise levels enable patients to relax Discreet treatment increases patient confidence and compliance3 RENASYS EZ PluS Specifications DescriptionrEnasys Ez PLUssize HxWxD (mm)361 x 240 x 170 Weight (kgs) range (mm Hg)40 to 200; cont.

8 And inter. therapyBattery Life (hrs)40recharge time (hrs)6 Waste Canister250ml and 800mlDisplayAnaloguePatient lock outYesiV Pole attachmentNew design Integrated systemBed attachmentNew design Integral hooksCarry bagSmith & Nephew Bag3rEQUirEmEntsPECifiCation notEsPortableCan be carried but should remain static if hook for bed mounting and clamp to permit IV pole range-40 to -200mmHg12 possible preset values (40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200mmHg)Free air displacement9 litres per lifeApproximately 40 hrsBattery life is dependent on amount of exudate and wound cyclesContinuous or IntermittentDisplayAnalogue displaySimple and intuitive controls mean fewer troubleshooting patient tampering with pressure size250ml or 800mlSealed opaque with solidifier. Choice of two optionsSolidifier with canisterYesCanister markingsYes250ml canister 10ml increments800ml canister 100ml FilterYeslow battery alarmYesGreen \ Amber lED indications plus audible alarmlow vacuum alarmYesIf the vacuum is 15mmHg below the set point an Amber lED indications plus audible alarm will canister alarmYesAmber lED indications plus audible vacuum alarmYesIf the vacuum is greater than 235mmHg an Amber lED indications plus audible alarm will activate.

9 The device will stop delivering therapyline blockage alarmYesAmber lED indications plus audible leak alarmYesAmber lED indications plus audible pump alarmNoAlarm mute buttonYesTo silence alarm for two minutes while the problem is rectified, button illuminates during clampsYesBespoke tubing connectors with integral sealing plug/cap to connectorCarrying bagSmith & Nephew BagMains power optionYesPower inputInternal Battery or 100-240 VACRENASYS EZ PluS Technical Specifications4 Dressing kits and consumablesRENASYS-G (Kit components) Trademark of Smith & NephewGauze kit componentsKitsSmallMediumLargeX-LargeWoo ding - ScottProduct codes66800216 - Round66800217 - Flat66800218 - Channel66800219 - Flat66800220 - Round66800221- Flat66800222 - Round66800212 Drain Flat or 10fr Flat or channel Flat or 19fr 19 fr Irrigation aspirationNon-adherent gauze 1 3in x 3in (7cm x 7cm) 1 3in x 8in (7cm x 20cm) 3 3in x 8in (7cm x 20cm) 3 3in x 8in (7cm x 20cm) 3 3in x 8in (7cm x 20cm)Antimicrobial gauze 1 package 4 x 4s 1 package Kerlix fluff 6 x 6s 1 Kerlix roll 2 Kerlix roll 2 Kerlix rollTransparent film 2 4in x (10cm x 12cm) sheets 2 6in x 8in (15cm x 20cm) sheets 2 8in x 12in (20cm x 30cm) sheets 2 8in x 12in (20cm x 30cm) sheets 2 8in x 12in (20cm x 30cm) sheetsConnective tubing 1 each 1 each 1 each 1 each 1 eachSaline bullet 1 bullet1 bullet2 bullets2 bullets2 bulletsSkin prep 1 packet 1 packet2 packets2 packets3 packetsStrip paste 1 strip 1 strip1 strip1 strip1 stripWound ruler 1 each 1 each1 each1 each1 eachWaterproof tape 2 strips 2 strips4 strips4 strips4 strips** The examples are just guidelines.

10 It will not be exact guidelines for all wounds. Rarely used tiny wounds Example: x x cm 38 cm or to moderate wounds with moderate depth Example: 8cm x 8cm x - 160 cm Most common kit surface area or full thickness wounds with significant depth Example: 10cm x 10cm x - 500 cm Xtra large surface area or full thickness wounds with significant depth. Example: 18cm x 18cm x - 2106 cm Same example as wound size for the XL kit. High Output wounds and/or with sediment. Indicated for fistulas and large abdominal kit contentsKitssmallmediumX-largeProduct codes66800491 Round66800493 Channel66800494 Flat66800497 RoundDrainFlat or 10frFlat or channel19 frNon-adherent gauze1 3in x 3in (7cm x 7cm)1 3in x 8in (7cm x 20cm)3 3in x 8in (7cm x 20cm)Antimicrobial gauze1 package 4 x 4s1 package Kerlix fluff 6 x 6s2 Kerlix rollTransparent film2 4in x (10cm x 12cm) sheets2 6in x 8in(15cm x 20cm) sheets2 8in x 12in(20cm x 30cm) sheetsConnective tubing1 each1 each1 eachSaline bullet1 bullet1 bullet2 bulletsSKIN-PREP 1 packet1 packet2 packetsStrip paste1 strip1 strip1 stripWound ruler1 each1 each1 eachWaterproof tape2 strips2 strips4 strips** The examples are just guidelines.