Home Healthcare *smith&nephew User Manual RENASYS GO

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Home HealthcareUser ManualRENASYS GO device 66801496 only*smith&nephewRENASYS GONegative Pressure Wound Therapy*smith&nephewRENASYS GONegative Pressure WoundTherapy300ml200ml100ml50ml

Healthcare provider's name:Healthcare provider's telephone number:Healthcare provider's mobile number:

EN*smith&nephewRENASYS GONegative Pressure WoundTherapyHome HealthcareUser ManualTable of Contents1. Introductionpage 42. When the device shouldor should not be usedIndications for useContraindicationsWarningsPrecautions777893. RENASYS GOsystem featuresDevice overviewCanistersProper use/orientationPower12121314154. RENASYS GO deviceoperationHow do I know if thedevice is working?Battery operation1617185. System setupDevice setupConnecting your dressingAttaching a new canisterReconnecting yourdressing19192021226. Alarms and troubleshooting 237. AccessoriesCary strapShoulder and extensionstrapsCarry bag8. Cleaning, maintenanceand expected life of device40409. Technical specifications4210. Caution statements4311. Contact information24 hour clinical hotlinesCustomer Care contacts444445404142

EN1. IntroductionThis RENASYS GO Home Healthcare User Manual will provide you withimportant information regarding the Smith & NephewRENASYS GO Negative Pressure Wound Therapy (NPWT) System.This system is prescribed to you by a trained and licensed healthcareprovider. This Home Healthcare User Manual will help you operate andmonitor your device.The RENASYS GO device should only be used with compatibleSmith & Nephew RENASYS products.*smith&nephewRENASYS GONegative Pressure WoundTherapy4

What is RENASYS GO Negative Pressure WoundTherapy (NPWT)?ENRENASYS GO is a therapy system that is applied to your wound and maypromote wound healing by removing fluid, including wound exudates andinfectious materials. This form of treatment is being widely used in bothhospitals and the home.How does it work?RENASYS NPWT systems consist of a device, a canister and a wounddressing kit.The dressing is applied to the wound bed and covered with a clear film.Once sealed, it is attached to the device through tubing and a canister.The device then draws fluid from the wound into the canister while theclear film helps to prevent bacteria from entering the dressing. Use of thissystem may also improve blood flow to help the wound heal.The RENASYS GO device is electrical and can be plugged into an electricaloutlet or can operate on its internal battery.How many hours a day do you need to use thetherapy?To receive the full benefit of the therapy, we recommend that the device bepowered on at all times or as prescribed by your healthcare provider.How long will it take to improve your wound?The length of time that the therapy takes to improve a wound is differentfor every patient. It will depend on your general condition, the size andtype of wound that you have and your prescribed treatment. In manycases, an improvement in the wound can be seen with the first dressingchange, but in some cases, it may take several weeks. The therapy maybe used to close the wound completely or may be stopped before thisand replaced with a different type of dressing. If your wound shows noimprovement, the therapy may be stopped. Your healthcare providerwill discuss when and why use of this device will be stopped based onassessment of your wound.5

ENWill it be painful?The first time therapy is turned on, you may feel a slight pulling sensation,but it should not be painful.If you experience any pain, speak to your healthcare provider. They mayrecommend changing the settings on your device or prescribe pain reliefmedication.How often will the dressings be changed?The dressings will usually be changed 2–3 times a week, in some cases itmay be more often. This will depend on your wound’s size, type, positionand drainage amount. Your healthcare provider will determine how oftenyour dressings needs to be changed.All dressing changes must be performed by a trained healthcare provider.Will the dressing changes hurt?Some people may experience slight discomfort during dressing changes,specifically during the cleaning of the wound. If you feel any discomfort, tellyour healthcare provider. They may change your device’s pressure settingor prescribe pain relief medication to help ease the discomfort.Can you move around while on the therapy?Usually, patients using the therapy can move around, but this will dependon the position of the wound and recommendations provided by yourhealthcare provider. If you are able to move around, the device can beunplugged and operate on its internal battery for up to 20 hours.6

EN2. When this device should or should not be usedWhen this device can be used (Indications for use)RENASYS GO is indicated for patients who would benefit from a suctiondevice (Negative Pressure Wound Therapy), as it may promote wound healingby removing fluid, including 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) Partial-thickness burns Flaps and graftsWhen the device should not be used(Contraindications)RENASYS GO should not be used if you have: Untreated osteomyelitis Exposed arteries, veins, organs or nerves Necrotic tissue with eschar present Malignancy in wound (with exception of palliative care to enhancequality of life) Non-enteric and unexplored fistulas Anastomotic sites7

ENWarnings1.This product should only be used as prescribed by your healthcareprovider. Do not use it on anyone other than the prescribed patient.2. Monitor your dressing and device during operation. If there isincreased bleeding, a change in fluid color or pain, contact yourhealthcare provider.3. If you see blood within the canister, power off the device and contactyour healthcare provider immediately.4. The canister is sealed shut and contains a solidifier packet that will gelthe wound fluid. The device and canister should be kept out of reachof children and pets.5. If you are unable to turn off the alarms, consult the Alarms andTroubleshooting section of this Home Healthcare User Manual.6. If the dressing feels or appears to be loose, consult the systemsetup section of this Home Healthcare Use Manual or contact yourhealthcare provider.7.If your wound looks more red than usual, has a foul smell or the skinaround your wound looks red or irritated, contact your healthcare provider.8. Place device at or below thelevel of the wound to ensurethe prescribed level of therapyis delivered.*smith&nephewRENASYS GONegative Pressure S GONegative Pressure WoundTherapyLevelof thewound300ml200ml100ml50ml9. Do not use the device near an oxygen tank oroxygen gernerator due to danger of explosion.10. Do not try to remove or change the dressing yourself. Your healthcareprovider must do this for you.8

ENPrecautions1.Do not change any of the settings on the device. The settings areprescribed by your healthcare provider.*smith&nephewRENASYS GONegative Pressure WoundTherapy300ml2. If your device has been in very hot or cold temperatures, let it returnto room temperature before powering it on to avoid damage to thedevice.200ml100ml50ml3. To provide proper delivery of your prescribed therapy, the tubing thatconnects the dressing to the canister should not be twisted, tangledor kinked.9

EN4. When showering or bathing, power off your device, then disconnectthe tubing and cap the ends of the quick click connectors with theattached end caps. The device is electronic and cannot be exposedto water. If water or other liquids get into the device, turn it off andcontact your healthcare provider.*smith&nephewRENASYS GONegative Pressure WoundTherapy300ml200ml100ml50ml5. The cords and tubing could cause strangulation. Keep away from yourhead and neck and be aware of tubing placement around children andanimals.6. This device has been tested for use in hospital and home settingsregarding interference with other devices. Your cell phone and otherelectronics that transmit signals may affect this device if placed inclose proximity. Keep your cell phone and other electronics thattransmit signals at least 2 feet away from the device at all times.*smith&nephewRENASYS GONegative Pressure WoundTherapy2 Feet300ml200ml100ml50ml10

7.ENDo not use the power suppy or power cord if they are damaged, wiresare frayed or exposed; you must run the device on it's internal batterypower. Contact your heathcare provider for a replacement powersupply and cord.8. The RENASYS GO device is only to be used with Smith & Nephewauthorized components. Use of any other products have not beenproven safe and effective with the RENASYS GO device.11

EN3. RENASYS GO system featuresDevice overviewStatus/Alarm indicatorPower buttonBattery statusindicatorStart/pausetherapyDisplayUp and DownselectorsO-ringAudio pauseInletportKeypad lockNote: When the device is powered on, the Status/Alarm indicator willilluminate green to indicate therapy is being provided. If an alarm occurs, theStatus/Alarm indicator will illuminate yellow.12

ENCanisters – 300ml and 750ml(300ml canister is lWhite quick clickconnector!T-connectorCanistertubeEnd capsOrange quickclick connectorNote: There are two types of dressing and canister connectors: One withwhite quick click connectors and one with orange quick click connectors.Both types are shown here.Note: Do not place tubing or end caps over the T-connector on the canistertubing with white quick click connectors.13!

Proper use/correct orientationephew*smith&n ORENASYS GPressure WoundNegativeTherapyNegative PressureTherapyhew*smith&nep GORENASYS Wound Incorrect orientationNegativeTherapyephew*smith&n GORENASYS Pressure WoundX XWoundNegative PressureTherapyphew*smith&neRENASYS GOEN14

ENPowerre WounNegative PressuTherapynephew*smith& S GORENASY dPower jackDC cordPower supplyPower cord inlet15

EN4. RENASYS GO device operationYour healthcare provider will set the device pressure setting based on yourprescribed therapy. You will be instructed on how often to run the deviceand when to notify your healthcare provider.Your healthcare provider will setup the device based on theRENASYS GO Negative Pressure Wound Therapy Instructions for Use.There is a lock on the device that will be set by your healthcare provider toavoid changes to your prescribed therapy. All buttons will be locked exceptthe Power and Audio Pause buttons. Do not change the therapy settingsprescribed by your healthcare provider.Ke y p a d Lo c k e d 1 0 0 mm H g * * *Power ON the RENASYS GO device by pressing and holding the Powerbutton for 2 seconds. Powering ON the device will start therapy.Power OFF the RENASYS GO device by pressing and holding the Powerbutton for 2 seconds. Powering OFF the device will stop therapy.16

ENHow do I know if the RENASYS GO device is working?While RENASYS GO is Powered on:1. The Status/Alarm indicator will illuminate green.2. The display will read either CONTINUOUS or INTERMITTENT on the topline of the display based on prescribed therapy. The second line on thedisplay will indicate the therapy setting.Con t i nuou s 1 0 0 mm H g * * * In CONTINUOUS mode, the device will deliver therapy constantly. In INTERMITTENT mode, the device will provide therapy for 5 minutesand then pause therapy for 2 minutes. This will repeat as long as yourdevice is set to INTERMITTENT mode.Note: Even if fluid is not actively moving though the tubing, negativepressure is still being delivered.17

ENIt is important to monitor the activity of the device while you are using thetherapy.IMPORTANT: Items to monitor include: The dressing.It should have a raisin-like appearance and be firm to the touch.Dressing compressed andfirm to the touchDressing decompressed andsoft to the touchIf your dressing is not compressed, press down around theedges of your dressing. If your dressing begins to draw down andcompress, you have resealed your dressing. If the dressing remainsdecompressed, contact your healthcare provider. The amount of fluid in the canister.If the canister is 2/3 full of fluid or greater, it needs to be replaced. The device display and indicator lights on the front of the device.For an explanation of any device display messages, indicator lights oraudio signals, refer to the Alarms and Troubleshooting section of thisHome Healthcare User Manual.Battery operationThe RENASYS GO device runs when plugged into an electrical outlet,or can be run using its internal battery for up to 20 hours. If the bottombattery status indicator light illuminates yellow, plug the device into anelectrical outlet to avoid the device turning off during therapy. The devicewill operate while the battery charges.18

EN5. System setupThere are times when you will need to disconnect from your device, suchas when you shower or wash, or when your canister needs to be replaced.Your device is electrical and cannot come into contact with water. Toavoid exposure, power off the device and disconnect the dressing tubingfrom the canister tubing before showering or washing. You will need toreconnect your dressing tubing to the canister tubing and power on thedevice as soon as you finish showering or washing.The clear film placed on top of the wound and the dressing tubing arewater resistant. You can shower or wash with dressings in place, as longas you do not soak them.The following sections walk you through the steps to setting upvarious components of the system:Device setupPower the device on. If the device is set to the CONTINUOUS mode, youshould have constant therapy delivered.If the device is set to INTERMITTENT therapy, your therapy will cycle on for5 minutes and off for 2 minutes.Note: Your device will be set to Home Healthcare Use mode by yourhealthcare provider, and the therapy settings cannot be changed. Thedevice may be Powered off to temporarily stop therapy (e.g. patientshower, dressing change, etc). When re-started, the device will operateusing the settings set up by the healthcare provider.19

ENDisconnecting your dressing1.Hold the quick click connectors above the wound to allow gravity tohelp ensure exudate does not leak from the tubing.2. Power off the device.3. Disconnect the canister tubing from the dressing tubing by applyingpressure to the connectors as shown:RENASYS Soft Portorange quick click connectorWhite connector4. Close the tethered caps on both of the quick click connector to sealthe tubing.20

ENAttaching a new canister1.Power off the device.2. Disconnect the dressing from the canister as described in theDisconnecting Your Dressing section.3. Open the orange canister clips on either side of the canister andgently pull the canister away from the device.4. Disposal of used canisters should follow facility protocols or localguidelines relating to the handling of potentially infected orbio-hazardous materials. Please contact your healthcare provider fordetails about disposal.5. Remove paper tape around the new canister tubing to release tubingto the full length.6. Open both orange clips.7.Align the canister so that the viewing window is facing forward.8. Push the canister gently over the inlet port of the device.9. Engage both canister clips. Clips will click when they are properlyengaged.*smith&nephewRENASYS GONegative Pressure WoundTherapy*smith&nephewRENASYS GO*smith&nephewRENASYS GONegative Pressure WoundTherapyNegative Pressure WoundTherapy*smith&nephewRENASYS GONegative Pressure l50ml21200ml100ml50ml

ENReconnecting your dressing1.Connect the dressing to the canister tubing by pushing the quick clickconnectors together.RENASYS Soft Portorange quick click connectorWhite connectorXNote: If you have orange quickclick connectors – Do not coverthe aeration disc located near theorange connector on your dressingtubing.Note: If you have white quickclick connectors – Do not coveror connect dressing tubing to theopen end of the t-connector that isinserted in the canister tubing.22

EN6. Alarms and troubleshootingA description of the device alarms and indicators is provided below.Use this section as a reference in the case your device alarms.If the alarm does not stop, contact your healthcare provider to inform themof the alarm condition.Keypad lockLocks the keypad to restrictaccidental adjustment oftherapy. When activated thelight will illuminate.PowerTurns the device on and off.Battery status indicatorShows the status of batterylife.Audio pauseSilences the alarm forapproximately 2-3 minutes.When activated the light willilluminate.Up selectorAllows the pressure settingto be increased and scrollthrough menu options.If a new alarm occurs, theAudio Pause will cancel.Down selectorAllows the pressure settingto be decreased and scrollthrough menu options.Start/pause therapyNot available when lockedfor homecare use.Allows therapy to be startedor paused by clinician whiledevice is unlocked.23

ENAlarm/Indicator:Device status:Display will show the prescribed therapyDevice is Powered On inContinuous Mode.Device is Powered On inIntermittent Mode.BatteryBa t t e r y 1 0 0The battery is fully chargedand has up to 20 hourstherapy time remaining.Device is not plugged into anelectrical outlet and batteryhas up to 10 hours therapytime remaining.F u l lmm H g * * *Device is not plugged into anelectrical outlet and batteryhas up to 6 hours therapytime remaining.Device is plugged into anelectrical outlet and batteryis charging.Ch a r g i n g 1 0 0mm H g * * *24

ENIndicator light/audio:Impact to therapy:Steps to remedy:Status/AlarmIndicator:Solid GreenStatus/AlarmIndicator:Solid GreenDevice is operatingnormally.N/ADevice is operatingnormally.N/ABattery Status TopIndicator:Solid GreenBattery Status TopIndicator:Flash GreenDevice is operatingnormally.N/ADevice is operatingnormally.N/ABattery Status Top Device is operatingIndicator:normally.Flash GreenN/ABattery StatusBottom Indicator:Solid yellowBattery Status Top Device is operatingIndicator:normally.Flash Green25N/A

ENAlarm/Indicator:Device status:!A t t e n t i o n!L owDevice is not plugged into anelectrical outlet and batteryis low.!RECHARGE!V . L owBa t t e r yBa t t e r y26Device is not plugged into anelectrical outlet and batteryis very low.

ENIndicator light/audio:Impact to therapy:Status/Indicator:Solid YellowDevice will continueto operate normallyfor 3 hours and willThe audible alarm stop operating oncewill soundthe battery is fullydischarged.Battery StatusBottom Indicator:Solid YellowThe audible alarmcan be pausedby pressing theAudio Pausebutton. Whenpressed the lightabove the buttonwill illuminate.Status/Indicator: Device will continueSolid Yellowto operate normallyfor 1 hour and willBattery Statusstop operating onceBottom Indicator: the battery is fullySolid Yellowdischarged.The audible alarmwill sound.The audiblealarm cannot bepaused.27Steps to remedy:Plug the device into anelectrical outlet.Therapy will continue to bedelivered while the devicebattery is charging.Plug the device into anelectrical outlet.Therapy will continue to bedelivered while the devicebattery is charging.

ENAlarm/Indicator:Device status:!RECHARGE!E X . L OWDevice is not plugged into anelectrical outlet and batteryis extremely low.!RECHARGE!BAT TERY! BAT TERY 1 0 0BAT TERYN OW !FA I LFA I LEDmm H g * * *Device is not plugged intoan electrical outlet anddevice battery is extremelylow. After 2 minutes in anextremely low charge state,the device will power off.Device is plugged into anelectrical outlet and batteryis not charging.Note: Device display andindicator lights will onlypresent the alarm statewhen the device is pluggedinto an electrical outlet.28

ENIndicator light/audio:Impact to therapy:Status/Indicator:Solid YellowThe battery hasonly 2 minutesof therapy timesBattery StatusBottom Indicator: remaining

Troubleshooting section of this Home Healthcare User Manual. 6. If the dressing feels or appears to be loose, consult the system setup section of this Home Healthcare Use Manual or contact your healthcare provider. 7. If your wound looks more red than usual, has a foul smell or the skin

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