Smith & Nephew RENASYS Negative Pressure Wound Therapy
Contents
1. NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios 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 the device is used exceeds 3V m the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 28 Electromagnetic environment guidelines Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3095 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the device requires continued operation during power mains interruptions it is recommended that the device be powere2. PROCEDURES FOR YOU TO FOLLOW IMMEDIATELY 1 Please read carefully the enclosed copy of Smith amp Nephew s Device Correction Notice including the Important Information and Cautions sections described in the Device Correction Notice Update your User Manuals IFU for the RENASYS range of devices in your possession Notify each of your clients and or patients of this Smith amp Nephew Correction Notice 4 Complete the Acknowledgement form below and fax or email to Medigas as soon as reasonably possible on Page 1 of 2 5 Contact Medigas at 1 866 446 6302 if you have any concerns or questions Thank you for your attention to this matter Sincerely Medigas the healthcare division of Praxair Canada Inc Email Rose Pontarini Praxair com ACKNOWLEDGEMENT FORM DEVICE CORRECTION RENASYS DEVICES have read and understood the information contained in this letter and have distributed copies to all relevant users as defined in the instructions Amendments To the User Manuals have read the Important Information section and the Cautions for leak alarms and blockage alarms that will be included in the amended User Manuals IFU for the RENASYS range of devices Institution Name Address Name amp Title Email Address Phone Signature Date Indicate here if you would like amended User Manuals IFU for RENASYS range of devices Quantity Please Fax or Email the
3. Precaution TAKE CARE NOT TO OVER TIGHTEN SCREW Rubber feet REF 66800611 If a rubber foot has become detached or is missing it may be replaced Use a small quantity of cyanoacrylate adhesive to reattach the rubber foot to the base of the device Rubber feet can be obtained as replacement parts Storage Prior to storage for more than 2 months ensure that the battery is fully charged Some battery discharge may occur in storage During long term storage recharge the battery every 10 months RENASYS GO should be stored between 0 25 C 32 77 F for optimal battery performance but can be stored between 10 55 C 14 31 F for short periods of time Returning device Prior to returning the device to your Smith amp Nephew authorized representative device must be cleaned according to the steps outlined under the cleaning section of this user manual Device should be returned within the original packaging EN Electromagnetic compatibility RENASYS GO REF 66800164 This equipment has been tested and found to comply with the limits for medical devices to IEC 60601 1 2 2001 These limits and test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a typical medical installation 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
4. UL 60601 1 IEC 60601 1 IEC 60601 1 2CAN CSA C22 2 No 601 1 30 Caution statements In order to ensure safe and proper performance the following conditions must be met e Allassembly operation adjustment modification maintenance and or repair should be carried out by qualified personnel authorized by Smith amp Nephew e No modification of this equipment is allowed e If using Class Power Supply REF 66800161 To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth e Use only the AC mains power cord provided with the device to prevent the potential for electrical shock hazard e f power cord is damaged wires are frayed or exposed do not use power cord Contact your Smith amp Nephew representative for a replacement cord e If the device is damaged the performance could be affected Do not use the device Contact your Smith amp Nephew authorized representative e When necessary the device may be isolated from AC mains power by removing the detachable AC mains power adapter cord The electrical installation of the room must comply with the appropriate electrical wiring standards e The product must be used in accordance with this user manual and all applicable labeling Failure to comply with these conditions will void any pertinent warranties This user manual is not intended as a guarantee or warranty It is intended only as a guide
5. 2 Inspect connections tubing and Soft Port aeration disc located on Soft Port near the orange quick click connector to ensure they are free of obstructions Ensure there are no kinks in canister tubing 3 Disconnect Soft Port from canister tubing at orange quick click connector Insert tethered cap into Soft Port connector Allow air to flow freely into canister e f alarm condition continues there is a potential issue with the device or canister Replace canister and contact your Smith amp Nephew authorized representative e If alarm condition resolves a blockage is present within the Soft Port Reassess and replace as needed Caution Do not wait for alarm activation to change canister At point of alarm activation canister contents have exceeded maximum volume capacity potentially impacting device alarm functionality Note Device and canister should be kept in an upright orientation to optimize canister over capacity alarm functionality while maximizing canister volume 20 B Alarm status with display screen Cause Remedy 21 EN Alarm status with display screen Cause Remedy High flow leak alarm WARNING od LEAK Device detects a significant leak in the system e Alarm will beep 3 times every 10 seconds e Status alarm indicator will flash amber e Once corrected alarm will automatically reset and status alarm indicator will retur
6. click connector Device start up Device operates on both battery and AC mains power If battery operation is required for first use of device battery must be charged from AC mains power until battery status top indicator light illuminates solid green During charging process the battery status top indicator light will flash green If AC mains power is required connect power supply to the AC mains power inlet on the side of device To activate device press and hold Power button for 2 seconds Device display will show Welcome Starting VX Standby 100 mmHg If device is being used for the first time the user will be given the option to select desired language PEnglish Dansk Language selection To change language selection 1 Turn device off 2 Simultaneously press and hold Up Ai Select Ib 4 Power buttons for 2 seconds 3 Language can now be selected using Up 4 and Down W buttons to scroll to desired language followed by Select I button 4 Pressing Select Ib button at this point will power on the device at a preset 80mmHg in continuous mode if the device is being used for the first time or the previously entered pressure setting Software version To access software version of a device Turn device off 2 Press and hold Power button for 2 seconds Device display will show Welcome Starting VX XX 3 The software version is provided on the lower righ
7. e Pressing audio pause button will pause audible alarm for approximately 2 3 minutes Fg THERAPY STOP o LOW VACUUM e Device will stop delivering therapy after pausing alarm 5 times without addressing condition Device is unable to achieve selected vacuum level due to internal device malfunction or a significant leak in the system 1 With device actively creating vacuum check wound dressing for air leaks Look for loose or decompressed dressing appearance listen for air movement around dressing and feel for areas less compressed or cooler in temperature Address identified leaks with transparent film or adhesive gel patch 2 Ensure the following connections are secure Orange quick click connector between Soft Port and canister tubing e Secure engagement of canister to device 3 Disconnect Soft Port from canister tubing at orange quick click connector and insert tethered cap into both connectors e If alarm condition continues there is a potential issue with the device or canister Replace canister and contact your Smith amp Nephew authorized representative e If alarm condition resolves an air leak is present within the wound dressing or Soft Port Reassess and replace as needed Note If low vacuum alarm is due to a leak in system the high flow leak alarm may also activate while low vacuum alarm is active Note If over vacuum alarm indicator is illuminated along with low vacuum indi
8. 750ml canisters RENASYS GO canisters use an integral two stage bacterial filter for protection of device against overflow and spread of aspirated micro organisms Canisters are designed for single patient use Do not re use Canisters are provided non sterile and should not be used in a sterile field Canisters should be changed at least once a week whenever there is a change in patient or in the event the canister contents reach maximum volume indication 300ml or 750ml fill line Do not wait for alarm activation to change canister Canisters may have to be changed regularly within single patient treatment episodes if exudate levels are high Check canisters regularly to monitor exudate levels ensuring they are below maximum volume indication 300ml or 750ml fill line Check canister for any signs of cracks or damage If noted discard and replace canister Ensure canister viewing window is checked frequently for signs of bleeding For patients with high risk of bleeding use 300ml canister EN Installing canister 1 Ensure device is off 2 Remove paper tape around canister tubing to release tubing to full length Open both orange clips on sides of canister 4 Align canister so that viewing window is facing forward Push canister gently over device inlet port 6 Engage both canister clips Clips will click when properly engaged 7 Following canister installation to verify functional complete bloc
9. Actively bleeding or have friable blood vessels or organs e Suffering from difficult wound hemostasis Untreated for malnutrition Noncompliant or combative e Suffering from wounds in close proximity to blood vessels or delicate fascia When monitoring patients for delivery of therapy ensure wound dressing is free of air leaks fully compressed and firm to the touch As a condition of use device should only be used by qualified and authorized personnel User must have necessary knowledge of the specific medical application for which NPWT is being used For patients with high risk of bleeding use 300ml canister Ensure the 300ml canister viewing is checked frequently for signs of bleeding In the event of heavy or viscous drainage drainage with sediment or when blood is present regular monitoring and more frequent dressing changes may be required to reduce the risk of interruption of therapy maceration infection and ensure proper exudate removal Underlying structures such as bone tendons ligaments and nerves should be covered with natural tissue or a non adherent dressing layer prior to applying the NPWT dressing to ensure protection and minimize the risk of damage from direct contact with the dressing To minimize the risk of bradycardia do not place NPWT in proximity to the vagus nerve 10 Ti 12 13 14 15 16 In the event a patient with spinal cord injury experiences autonomic dysrefle
10. EN Clinician information total time This feature is available with software version 0 66 and later Device displays total number of hours accumulated in active mode This time cannot be reset To access total time display screen 1 Turn device off 2 Simultaneously press and hold Down vy Select I gt Power D buttons for 2 seconds 3 Press Down button to scroll to total time option Press Select gt to show the following display screen Total Time xx xxx H 4 Display will show for 5 seconds and then return to main menu Clinician information battery charge This feature is available with software version 0 66 and later Device displays percentage of battery charge remaining To access battery charge display screen 1 Turn device off 2 Simultaneously press and hold Down vy Select Ib Power O buttons for 2 seconds 3 Press Down button to scroll to battery charge option Press Select Ib to show the following display screen Battery X X X 96 Charge 4 Press Select I button to return to the main menu EN Battery power Device can be used on battery power to allow greater user mobility A fully charged battery will last up to 20 hours During therapy if battery level is low the device can be plugged into AC mains power without interrupting therapy Battery will recharge while therapy continues to be delivered Battery status indication RENASYS GO
11. Foam or gauze must not be tightly packed or forced into any wound area Over packing may interfere with distribution of NPWT evenly across the wound This may decrease the ability of the wound to properly contract and permit exudate to remain in wound 6 In the event defibrillation is required disconnect device from wound dressing prior to defibrillation Remove wound dressing only if its location will interfere with defibrillation 7 Device is not MRI compatible Do not bring device into MRI suite Prior to entering MRI suite disconnect device from dressing Dressing can remain intact on patient 8 Device is unsuitable for use in areas where there is danger of explosion e g hyperbaric oxygen unit EN 9 When operating transporting or disposing of device and accessories there is risk of infectious liquids being aspirated or contamination of device assembly through incorrect use Universal precautions should be observed whenever working with potentially contaminated components or equipment Device and canister kits are provided non sterile and should not be placed within a sterile field Precautions 1 More frequent device and wound dressing monitoring should be taken for patients who are or may be e Suffering from infected blood vessels Receiving anticoagulant therapy or platelet aggregation inhibitors in addition to patients with intrinsic coagulation problems such as low platelet counts e
12. If keypad on user interface has not been used for 15 minutes keypad will automatically lock In active mode if keypad on user interface has not been used for 15 minutes keypad will automatically lock The light above keypad lock button will illuminate solid blue This feature is available with software version 0 66 and later To unlock user interface press and hold Keypad Lock button for 2 seconds Active mmHg Keypad 100 Note Locking keypad only locks row of keys under display screen Power Button is not locked Turn off the device Press and hold Power D button for 2 seconds to power off device Modes of Operation RENASYS GO offers both continuous and intermittent modes Selection of therapy mode setting is a clinical decision based on physician judgment wound type exudate level exudate consistency and patient comfort In continuous mode device will maintain selected pressure setting without stopping until switched off In intermittent mode device cycles on and off in increments of 5 minutes ON active vacuum and 2 minutes OFF no vacuum Intermittent therapy is not recommended for e Highly exudating wounds e Wounds with tunnels or undermining e Wounds in difficult areas where maintaining a seal is problematic e Patients who experience pain during intermittent therapy To change therapy between continuous and intermittent mode 1 Turn device off 2 Simult
13. SA NV Tel 32 2 702 2911 Belgium Hector Henneaulaan 366 Fax 32 2 702 2904 1930 Zaventem customerservice benelux smith nephew com Smith amp Nephew Inc Canada 2250 Alfred Nobel Boulevard ud a ae St Laurent Quebec H4S 2C9 i Smith amp Nephew A S Tel 45 4580 6100 Denmark Slotsmarken 14 Fax 45 4580 6151 2970 Hoersholm sn dk smith nephew com Eia oo x Tel 358 0 207 866 300 AG Vantaa Fax 358 0 207 866 320 RUE dp ida Tel 33 02 43 83 23 23 France 25 Blvd Marie et Alexandre Oyon rax uin 9 EE 2418 72019 Le Mans Cedex 2 seiesmithnepnew con Sd ae sea Tel 49 040 87 97 44 0 Germany Osteibiooks ii 7 Fax 49 040 87 97 44 375 D 22869 BERLINS d info smith nephew com Smith amp Nephew Healthcare Ltd Customer Care 01276 9700 ireland Healthcare House Fax 01276 4970 101 Hessle Road orders oxygen care ie Hull HU3 2BN 24hr Clinical Support 1800 303622 Smith amp Nephew Tel 800 393 060 numero verde attivo 8 30 18 00 Wound Management 033 0094224 Italy a IDE Fax 039 6094274 Via de Capitani 2A i ae 23864 Agrate Brianza MB Centro Assistenza Clienti milan LOGCSM smith nephew com Smith amp Nephew Wound Management Japan Tokyo Warehouse Center C 3F Tel 81 03 5667 2166 3 5 1 Rinkai cho Edogawa ku Tokyo 134 0086 Japan XXX EN Smith amp Nephew B V ied uu Tel 020 654 39 99 Netherlands P Fax 020 654 20 99 Bezoekadres customerservice benelux smith nephew com Kruisweg 637 213
14. devices in the vicinity However there is no guarantee that interference will not occur in a particular installation Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Immunity test IEC 60601 test level Electrostatic 6 kV contact discharge ESD 8 kV air IEC 61000 4 2 Electrical fast 2 kV for power supply lines transient burst IEC 61000 4 4 1 kV for input output lines Surge 1 kV differential mode IEC 61000 4 5 2 kV common mode Voltage lt 5 U dips short gt 95 dip in U for 0 5 cycle interruptions 40 U and voltage 60 dip in U for 5 cycles variations on 70 U power supply 30 dip in U for 25 cycles input lines lt 5 U T IEC 61000 4 11 29596 dip in UJ for 5 sec Compliance level x6 kV contact x8 kV air 2 kV for power supply lines Not applicable 1 kV line to line 2 kV line to earth gt 95 for 10ms 60 for 100ms 30 for 500ms gt 95 for 5000ms NOTE U is the a c mains voltage prior to application of the test level Power frequency 3 A m 50 60Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz NOTE 1 At 80 MHz the higher frequency range applies 3 A m 3 Vrms 3 V m
15. the RENASYS GO Negative Pressure Wound Therapy NPWT system This device REF 66800164 is intended for use by or on the direction of a trained and licensed physician This manual is intended to aid in the training of personnel and to provide a reference for experienced users Device description The RENASYS GO suction device is designed to provide Negative Pressure Wound Therapy to a closed environment over a wound in order to evacuate exudates from the wound site to a disposable container which may promote wound healing via removal of fluids including irrigation and body fluids wound exudates and infectious materials The closed environment is created by applying a RENASYS sterile wound dressing to the wound site and connecting the sealed wound to the suction device The RENASYS GO runs on AC mains power with an AC power adaptor or internal battery power The internal battery charges when the device is plugged into AC mains power both during operation and when turned off and not in use The RENASYS GO should be positioned no more than 19in or 50cm higher than the wound and face user s operator s location For proper and effective use of the RENASYS GO device use only with RENASYS GO canisters RENASYS dressing kits and RENASYS ancillary componentry Refer to instructions for use provided with dressing kits for additional information on dressing use and maintenance The RENASYS GO is a portable Negative Pressure Wound T
16. 2 NB Hoofddorp Smith amp Nephew Limited New Zealand PO Box 442 Tel 64 9 828 4059 Shortland Street Fax 64 9 820 2866 Auckland 1140 Smith amp Nephew A S oin Tel 47 66 84 20 20 Norway Fax 47 66 84 20 90 Bes ksadresse norway smith nephew com Nye Vakasvei 64 Y pres 1395 Hvalstad Smith amp Nephew Lda Portugal Parque Tejo Tel 351 21 446 0650 8 EN 10 Km 131 Fax 351 21 446 0679 2625 445 Forte da Casa Smith amp Nephew Pty Ltd Tel 27 0 31 242 8111 South Africa PO Box 92 Fax 27 0 31 242 8120 Pinetown 3600 i Smith amp Nephew SAU Spain Fructu s Gelabert 2 y 4 Tel 34 93 373 73 01 P 08970 Sant Joan Desp Fax 34 93 373 7453 Barcelona Smith amp Nephew AB Sedan Kraketorpsgatan 20 Tel 46 31 746 58 00 PO Box 143 Fax 46 31 87 05 32 431 22 M nldal Smith amp Nephew AG Switzerland Glutz Blotzheim Strasse 1 m 4502 Solothurn Smith amp Nephew Ltd ti Tel 90 212 226 22 55 Orkide Sokak NO 8 E Turkey z Fax 90 212 226 44 47 Bah ek y 34473 info turkey smith nephew com Istanbul Turkey Smith amp Nephew FZE Level 4 United Arab Tel 971 4 429 9111 Emirates National Bank of Abu Dhabi Building Fax 971 4 429 9100 Dubai Health Care City PO Box 9715 Dubai United Kingdom Smith amp Nephew Healthcare Ltd Healthcare House 101 Hessle Road Hull HU3 2BN Customer Care 01482 673848 Fax 01482 222206 orders uk smith nephew com 24hr Clinical Support 1800 9155394 United
17. Completed Response Form to Rose Pontarini Praxair com or Fax 416 365 0092 Page 2 of 2 7X smith amp nephew RENASYS GO Negative Pressure Wound Therapy 2 smith amp nephew RENASYS GO Negative Pressure Wound Therapy Clinician User Manual REF 66800164 x only Clinician User Manual only Table of contents Introduction Device description Features and functions Important information Monitoring NPWT Indications for use Contraindications Warnings Precautions Physician orders Glossary of symbols Dressing changes Canister selection Installing canister Removing or changing canister Connect RENASYS Soft Port dressing and canister Disconnect RENASYS Soft Port dressing and canister Device start up Software version Language selection EN 7X smith amp nephew RENASYS GO Negative Pressure Wound Therapy Starting therapy Pause adjust therapy Lock or unlock the keypad Turn off the device Modes of operation Clinician information therapy time Clinician information total time Clinician information battery charge Battery power Troubleshooting guide Accessories Maintenance Device replaceable components Storage Returning device Electromagnetic compatibility Specifications Caution statements Limited warranty Global customer assistance EN Introduction This user manual contains important information regarding the safe and effective operation of
18. For medical questions please consult a physician For additional product information or a specific product question please refer to the numbers listed in the NPWT Customer Care Details section of this user manual 3l EN LIMITED WARRANTY LIMITATION OF REMEDIES LIABILITY The Smith amp Nephew negative pressure wound care electro mechanical device Device is warranted against defects in workmanship and materials for the warranty period specified below Warranty Period Smith amp Nephew reserves the right to discontinue any Device or change any Device s specifications or designs from time to time For any Device that fails to meet the foregoing warranty this warranty provides and is restricted to replacement or repair onsite service not included as elected by Smith amp Nephew in its sole discretion If Smith amp Nephew replaces a Device under this warranty and requests Customer to return the Device that was replaced Customer will be invoiced at Smith amp Nephew s then current list price for the replacement Device if Customer does not return the replaced Device within thirty 30 days after Smith amp Nephew s shipment of the replacement Device This warranty does not cover and is voided by any of the following i a warranty claim not made within the first to occur of expiration of the Warranty Period or thirty 30 days following the failure of the Device to perform as warranted ii a Device packaged or lab
19. NASYS Devices Amended User Manuals Instructions for Use Dear Customer Following a recent review of post marketing surveillance information regarding our RENASYS range of Negative Pressure Wound Therapy NPWT devices Smith amp Nephew is issuing a Device Correction Notice to announce the implementation of amended User Manuals for the RENASYS Go 66800164 RENASYS EZ Plus 66800697 and RENASYS EZ Max 66801309 devices and amended Instructions for Use IFU for the RENASYS Foam amp Gauze Dressing Kits to re emphasize the importance of patient monitoring requirements during negative pressure wound therapy PLEASE NOTE THAT THIS CORRECTION DOES NOT REQUIRE ANY RETURN OF RENASYS NPWT PRODUCTS The User Manuals IFU amendments will remind customers that the dressing is to be checked regularly to ensure that pooling is not occurring beneath the dressing and remind users not to rely solely on the device alarms to ensure that therapy is being effectively delivered The essential elements of the revised User Manuals IFU are provided in this letter and the amended User Manuals IFU are available upon request The revised User Manuals IFU will include the following Important information section Important information Monitoring NPWT Carefully monitor the patient device and dressing frequently to determine if there are any signs of bleeding exudate accumulation pooling infection maceration or loss of Negative Pressure W
20. O ring should be replaced after each patient use as the O ring can become worn over time potentially creating a source of air leak that may impact alarm functionality 1 To replace the device inlet port O ring the existing O ring must be carefully removed using a plastic removal tool ensuring that the inlet connector is not damaged during removal 27 EN 2 Clean the device inlet port and carefully slide new inlet port O ring onto device inlet port checking that any rolling of the O ring is corrected once it is located in the groove of the inlet port DO NOT LUBRICATE THE O RING NOTE Smith amp Nephew does not offer a plastic removal tool to be used with the RENASYS GO device Plastic removal tools may be purchased from vendors such as Golem Gear SKU GG Yellow Pick Odor filter REF 66800061 To minimize unpleasant odors from RENASYS GO devices it is recommended that the device odor filter be replaced between each patient use Note The presence of device odor does not impact the functionality of the device 1 To change or verify the presence of the odor filter turn the device over and lay it on a soft surface to avoid damage 2 Remove the Pozidriv screw holding the rear flap and open the flap to reveal the odor filter 3 Remove the two odor filter elements and replace with 2 new odor filter elements 4 Close the door flap and insert screw tightening only until the door flap is flush with the case
21. PAIR OR REPLACEMENT BY SMITH amp NEPHEW AS PROVIDED FOR IN THIS WARRANTY EXCEPT FOR THIS LIMITED LIABILITY OF SMITH amp NEPHEW SMITH amp NEPHEW UNDER NO CIRCUMSTANCES WILL BE LIABLE FOR ANY A CLAIM FOR DAMAGES OR OTHERWISE WHETHER ARISING FROM BREACH OF CONTRACT TORT INCLUDING NEGLIGENCE OR OTHERWISE AND WHETHER OR NOT BASED ON OR FLOWING DIRECTLY INDIRECTLY OR AS A CONSEQUENCE OF A WARRANTY CLAIM BREACH OF CONTRACT A TORT BREACH OF LAW OR ANY OTHER CAUSE OR LEGAL THEORY OR B DIRECT INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGES LOSSES OR EXPENSES ARISING FROM THIS AGREEMENT OR ITS PERFORMANCE OR LACK THEREOF OR IN CONNECTION WITH THE SALE OR USE OF OR INABILITY TO USE THE DEVICE INCLUDING BUT NOT LIMITED TO LOSS OF PROFIT OR ANTICIPATED SAVINGS LOSS OF ANTICIPATED PROFIT COST OF COVER FOR REPLACEMENT OR ALTERNATIVE PRODUCT ECONOMIC LOSS LOSS OF DATA WASTED EXPENDITURE OR LOSS OF REPUTATION OR GOODWILL Global customer assistance For more information regarding RENASYS GO or for additional customer assistance please refer to Smith amp Nephew customer care center details below Smith amp Nephew Pty Ltd 315 Ferntree Gully Road Tel 61 3 8540 6777 Australa MR A ey Fax 61 3 9544 5086 Victoria 3149 Smith amp Nephew GmbH Concorde Anes Park C3 jel eae 170 79102 Austria sterreich Fax 43 170 79101 A 2320 Schwechat info austria smith nephew com Smith amp Nephew
22. SYS Foam amp Gauze Dressing Kits to re emphasize the importance of patient monitoring requirements during negative pressure wound therapy Smith amp Nephew has indicated that this correction does not require any return of RENASYS NPWT products Smith amp Nephew s Device Correction Notice indicates that the User Manuals IFU amendments will remind customers that the dressing is to be checked regularly to ensure that pooling is not occurring beneath the dressing and remind users not to rely solely on the device alarms to ensure that therapy is being effectively delivered Smith amp Nephew also indicates that the essential elements of the revised User Manuals IFU are provided in the Device Correction Notice and that the amended User Manuals IFU are available upon request by calling Smith amp Nephew at 1 800 463 7439 or email Canadian Order smith nephew com Alternatively if you prefer Medigas can order amended User Manuals IFU for you Please refer to the enclosed copy of Smith amp Nephew s Device Correction Notice for additional detail including a description of the Important Information section and Caution Lack of Blockage alarm and Caution Lack of Leak alarm sections that Smith amp Nephew will include in the User Manuals IFU Please note that this affects Smith amp Nephew RENASYS Go 66800164 RENASYS EZ Plus 66800697 RENASYS EZ Max 66801309 devices and the RENASYS Foam amp Gauze Dressing Kits user manuals
23. States Smith amp Nephew Inc 970 Lake Carillon Drive St Petersburg FL 33716 XXX Tel 1 800 876 1261 Fax 727 392 6914 customercare largo smith nephew com Smith amp Nephew Inc 970 Lake Carillon Drive St Petersburg FL 33716 USA Smith amp Nephew Medical Ltd EC REP Hull HU3 2BN England 0297 www smith nephew com www globalwoundacademy com Customer Care Center 1 800 876 1261 T 727 392 1261 F 727 392 6914 66800753 only Trademark of Smith amp Nephew PIO4116 2014 Smith amp Nephew Certain marks Reg US Pat amp TM Off 12 2014 07740565712544772
24. ale Alberta Health Mm Services Equipment amp Product Advisory Alberta Health Services news and recommendations about clinical equipment and products EQUIPMENT amp PRODUCT INFORMATION RENASYS Negative Pressure Wound Therapy NPWT System and Kits Issue Medigas reports that Smith amp Nephew is issuing amended User Manuals for RENASYS pumps Go EZ Plus and EZ Max models and Instructions for Use IFU for all RENASYS Foam Dressing and Gauze Dressing Kits to re emphasize the importance of patient monitoring requirements during therapy Equipment amp Product Advisory Action i Ensure all users and potential users are aware re o da H Review and follow the amendments to User Manuals and IFU vendor notice pp 1 2 and Manual and IFU attachments These include but are ZONES Sites not limited to patient monitoring and lack of blockage or leak alarms Clinical Areas Affected e Carefully monitor the patient device and dressing frequently for bleeding exudate accumulation pooling infection maceration or loss NORTH ZONE ZONE of Reb n P pees e Do not rely solely on the device alarms that therapy is being EDMONTON ZONE delivered effectively or that bleeding or pooling is not occurring Pay ALL sites special attention to risks of bleeding and loss of therapy when considering home use CENTRAL ZONE e Be aware of other important factors that may impact therapy ALL sites and or safety including port alignment exud
25. aneously press and hold Down y Select IP Power O buttons for 2 seconds 3 Use Up or Down y buttons to scroll between continuous and intermittent mode Press the Select I gt button to confirm Once therapy is started display screen will show which mode of therapy has been selected Clinician information therapy time Device displays information which allows clinicians to see therapy time total hours and minutes of continuous or intermittent therapy delivered to the patient To access therapy time 1 Turn device off i Simultaneously press and hold Down y Select I gt Power O buttons for 2 seconds Use Down button to scroll to show time d option Press Select I gt to show the following display screen Time XX Active x x x x x H 4 Therapy time display will show for 5 seconds and then return to main menu To reset therapy time 1 Use Down button to scroll to clear time option Press Select Ib button to show the following display screen Clear Active Time x Press Select Ib button again to confirm that you want to clear active time e Use Down y button to scroll to yes option Press Select I gt button to show the following display screen Active Time Cleared 4 Display will show for 5 seconds and then return to main menu Active time should be cleared between patients This will allow the clinician to monitor patient therapy compliance
26. ate characteristics CALGARY ZONE canister orientation tubing height removal of wound filler skin grafts Foothills Medical Centre e Be aware of circumstances that can prevent alarms for blockages or South Health Campus leaks SOUTH ZONE Review your inventory for RENASYS pumps and kits Update the User Brooks Health Centre Manual for pumps and IFU for kits for any items currently in your area by printing the relevant attachments You may also request copies from Smith amp Nephew at 1 800 876 1261 Pumps and kits will be shipped e ALL clinical areas including with updated Manuals and IFU from the manufacturer going forward Community Services Home Complete and return the Medigas Acknowledgement form to Care Seniors Health Long Rose Pontarini praxair com or fax 1 416 365 0092 vendor notice p 4 Term Care Ambulatory attached Medicine Hat Regional Hospital oa Complete and return the attached E amp P Advisory Response Form to Contact ep advisory albertahealthservices ca or fax 403 955 9981 Holly Meyer MSc If you are not a user of these products no response is required Director AHS Product Quality and Safety p Phone 403 955 9923 green n E Holly Meyer albertahealthservices ca healthy Wound Management T 905 813 7770 Ze We are smith amp nephew Smith amp Nephew Inc F 905 813 7775 2280 Argentia Road www smith nephew com Mississauga Ontario L5N 6H8 Canada February 26 2015 DEVICE CORRECTION RE
27. bsequent dressing changes should occur 2 3 times per week 3 Inthe event of heavy or viscous drainage drainage with sediment or when blood is present regular monitoring and more frequent dressing changes may be required 4 When dressing a wound involving a difficult to seal anatomy or exposure to external moisture frequent inspection of dressing is recommended to ensure a seal is maintained Ensure wound dressing is fully compressed and firm to the touch 5 Ensure all wound filler material placed in the wound has been removed before redressing the wound If foam dressing adheres to the wound apply saline into the wound dressing and let it set for 15 30 minutes before gently removing the foam Appropriately discard used wound dressings observing your institution s protocol for medical waste handling 6 As with all adhesive products apply and remove dressing carefully from sensitive or fragile skin to avoid skin stripping especially after frequent dressing changes Use of skin sealant may assist with protection of periwound skin 7 Monitor patient for any signs of local or systemic infection by checking dressing frequently Infected wounds may require more frequent dressing changes As NPWT is not intended to directly treat infection if there are any signs of systemic infection or advancing infection at wound area contact treating clinician immediately Canister selection Device is to be used with RENASYS GO 300ml or
28. cator follow troubleshooting steps for over vacuum alarm Alarm status with display screen Cause Remedy High vacuum alarm WARNING HIGH VACUUM Vacuum level is higher than NPWT set point by 15mmHg for more than 30 seconds e Audible alarm will beep 3 times every 10 seconds Status alarm indicator will flash amber This audio alarm cannot be paused and must be investigated by healthcare provider immediately and corrected Once corrected alarm will automatically reset and status alarm indicator will return to solid green Device has detected a high vacuum condition potentially due to line blockage or device malfunction Inspect connections and tubing to ensure they are free of obstructions Ensure there are no kinks in canister tubing Replace canister If alarm condition continues device may have malfunctioned Contact your Smith amp Nephew authorized representative Over vacuum alarm 13 THERAPY STOP OVER VACUUM 1 THERAPY STOP Restart Device The system has encountered an excessively high vacuum of gt 235mmbg e Vacuum safety switch will operate and device will stop delivering therapy Audible alarm will beep 3 times every 10 seconds Status alarm indicator will flash amber This audio alarm cannot be paused and must be investigated by healthcare provider immediately and corrected Device has reached high vacuum level gt 235mmbH
29. conds Status alarm indicator will flash amber Service and repair required Contact your Smith amp Nephew authorized representative Battery failed alarm This feature is available with software version 0 66 and later BATTERY FAILED 100 mmHg Battery within device has failed Battery status bottom indicator will flash amber Therapy can only be continued by keeping device plugged into AC mains power Status alarm indicator will flash amber Note This will only display when connected to AC mains power Internal hardware failure Contact your Smith amp Nephew authorized representative 24 Accessories Carry straps To attach carry strap to device Co TT 1 Feed end of open strap behind location pin on side of device 2 Pull strap through and feed the end behind clip on carry strap 3 Close clip to secure strap 4 Repeat steps 1 3 on other side of device Once both sides of the carry straps are connected to device they can be joined together to make the short carry strap The short carry strap can be used to attach the device to a wheelchair or IV pole when moving patients Shoulder and extension straps The carry strap can be extended to allow the device to be carried on the shoulder or across the body Place the padded section of the shoulder strap against shoulder for maximum comfort when carrying device CLO ZZ Note Device carry straps are designed for s
30. contains a lithium ion rechargeable battery There are several battery level indicators on RENASYS GO device Indicator Battery level Action Battery is fully charged and has up to No action required 20 hours active therapy remaining Battery status top indicator will illuminate solid green Battery Full 100 mmHg Battery has up to 10 hours active No action required therapy remaining Battery status top indicator will flash green remaining Battery status top indicator will flash green and battery status bottom indicator will illuminate solid amber k Battery has up to 6 hours active therapy No action required Battery has up to 3 hours active therapy Audio alarm can be paused remaining by pressing the audio pause Attention Battery status bottom indicator will button on user interface Low Batter B illuminate solid amber Plug device into AC mains Audible alarm will beep 2 times every power to charge battery 30 seconds Battery has up to 1 hour active therapy Device should be plugged remaining into AC mains power to RECHARGE Battery status bottom indicator will flash charge battery and ensure v Low Battery i amber continued delivery of Audible alarm will beep 3 times every therapy 10 seconds Battery has only 2 minutes of active Device should be plugged therapy remaining into AC mains power or RECHARGE g Battery status bottom indicator will flash therapy will discontinue EX LOW BATTERY amber Audib
31. d from an uninterruptable power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP d 1 2 NP 80 MHz to 800 MHz d 2 3 NP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol qe EN Guidance and manufacturer s declaration electromagnetic emissions RENASYS GO REF 66800164 The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidelines RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not li
32. edy Inactive alarm This feature is available with software version 0 66 and later Attention INACTIVE Device has been left in standby mode for longer than 15 minutes e Alarm will beep 2 times every 30 seconds Status alarm indicator will flash amber AUDIO PAUSED INACTIVE e Pressing audio pause button will pause audible alarm for 15 minutes Alarm can only be paused once Device has been left in standby mode without any keys being pressed for longer than 15 minutes Either select pressure setting and start therapy or turn device OFF until therapy is required 23 EN Alarm status with display screen Cause Remedy Battery See battery status and alarm section of manual for screen messages Battery partially discharged or depleted Plug unit into AC mains power to charge battery Keypad lock on Keypad Locked 100 mmHg When lock is active keypad will illuminate solid blue User interface is locked Unlock by pressing and holding keypad lock button for 2 seconds Device failed alarm FAILED Return Fg DEVICE ft Please Device has an unrecoverable error Status alarm indicator will flash amber Internal hardware or software error Contact your Smith amp Nephew authorized representative Device not calibrated alarm bg DEVICE NOT CALIBRATED Device will not operate Alarm will beep 3 times every 10 se
33. eled by someone other than Smith amp Nephew or its authorized agents iii a Device not used in compliance with the specifications instructions or claims for use of the Device iv a Device used in conjunction with disposables accessories or any other products not specified for use with the Device lv a Device used in conjunction with expired or reprocessed disposables accessories or other products specified for use with the Device vi modification of the Device vii damage due to misuse reprocessing alteration unauthorized repair or negligent handling or damage due to lack of care by the owner user or handler of the Device including but not limited to storage handling or cleaning and viii any other damage inflicted to a Device by the owner user or handler This warranty applies only to the original buyer from Smith amp Nephew or its authorized distributor and is not transferable THIS WARRANTY IS THE SOLE WARRANTY OF SMITH amp NEPHEW ALL OTHER WARRANTIES OF ANY KIND OR DESCRIPTION WHATSOEVER INCLUDING WARRANTIES OF MERCHANTABILITY SATISFACTORY QUALITY AND FITNESS FOR A PARTICULAR PURPOSE EXPRESSED OR IMPLIED ARE EXCLUDED TO THE FULLEST EXTENT PERMITTED BY LAW 32 RENASYS NPWT electro Two 2 years from date mechanical devices of delivery to original inclusive of the power buyer cord and power supply CUSTOMER S SOLE REMEDY AND SMITH amp NEPHEW S SOLE LIABILITY FOR ANY CLAIM WILL BE THE RE
34. f wound volume of drainage integrity of dressing seal assessment of bacterial burden and patient s risk of infection Do not use a dressing kit with breached or damaged packaging Use of NPWT presents a risk of tissue in growth Tissue in growth may be reduced by reducing therapy pressure using a wound contact layer or increasing the frequency of dressing changes NPWT should not be painful If patient reports discomfort consider reducing pressure setting and use of a wound contact layer Pressure setting is a clinical decision based on individual characteristics of patient and wound Factors to consider include location of wound volume of drainage and integrity of dressing seal Maintain regular monitoring of device and wound site during therapy to ensure therapeutic treatment and patient comfort T 18 19 20 21 22 23 24 25 26 27 Device is only to be used with Smith amp Nephew authorized components Use of any other products have not been proven safe and effective with RENASYS GO device Ensure canister tubing and RENASYS Soft Port are installed completely and without any kinks to avoid leaks or blockages in vacuum circuit Position device and tubing appropriately to avoid risk of a trip hazard Device and system tubing should be positioned no more than 19 inches or 50cm higher than the wound to ensure optimization of therapy and prevent therapy interruption When bathing or showe
35. g Press and hold power button for 2 seconds to turn device OFF Inspect connections and tubing to ensure they are free of obstructions Ensure there are no kinks in canister tubing Replace canister Turn device back ON by pressing and holding power button for 2 seconds If alarm condition continues device may have malfunctioned Contact your Smith amp Nephew authorized representative EN Alarm status with display screen Cause Remedy Complete blockage canister over capacity I WARNING BLOCKAGE FULL Device detects a complete blockage in vacuum circuit There is no negative pressure at wound site e Audible alarm will beep 3 times every 10 seconds Status alarm indicator will flash amber Once corrected alarm will automatically reset and the status alarm indicator will return to solid green AUDIO PAUSED I BLOCKAGE FULL e Pressing audio pause button will pause audible alarm for approximately 2 3 minutes tt THERAPY STOP It BLOCKAGE FULL e The device will stop delivering therapy after pausing alarm 5 times without addressing condition There is a complete blockage in system this includes a canister where contents have exceeded maximum volume capacity or in the instance that the internal canister filter is covered with exudate 1 Check canister If contents have reached maximum volume indication 300ml or 750ml fill line replace canister
36. h amp Nephew authorized representative or distributor if service is required Cleaning Adherence to facility directives concerning hygiene is of prime importance The instructions supplied with all cleaning agents as well as sterilization and or disinfection units must be followed Cleaning of the RENASYS GO outer housing should be done in accordance with the guidelines below e Wipe down device surface with a damp soft cloth e Use a mild cleaning agent disinfectant or an antimicrobial agent and ensure its compatibility with plastics Follow manufacturer s guidelines for use of cleaning or disinfectant agents e Dampen another soft cloth with clean water and wipe down all surfaces to remove any excess solution e Dry with a separate soft cloth e Do not use solvents or abrasives e Do not immerse any part of RENASYS GO in fluid directly spray any cleaner onto device or use a wet cloth that is dripping fluid No fluids should be allowed to enter device If any liquids penetrate device contact your local distributor Device replaceable components As performed by appropriately trained personnel RENASYS GO replaceable components including the Inlet O ring odor filter and rubber feet may be purchased through Smith amp Nephew Contact your Smith amp Nephew authorized representative or distributor for more information Inlet O ring REF 66800603 To ensure the canister seal is secure the device inlet port
37. herapy NPWT device It is designed to be used with Smith amp Nephew power supply REF 66800161 Features and functions User interface Power button Display screen Up and down selectors Keypad lock 3 smith amp nephew RENASYS GO leg Negative Pressure Wound Therapy t O ring Status alarm indicator Battery status indicator Start pause therapy and select Audio pause Inlet port Canisters 300ml and 750ml 300ml canister shown here Canister clips 9 Viewing window Tethered connector caps Quick click connector EN Proper use correct orientation Incorrect orientation RENASYS GO device may also be used in a horizontal orientation with device facing upward However to maximize canister volume and optimize canister over capacity alarm upright device orientation is recommended Caution When device is operating in horizontal orientation facing upward alarm functionality may be compromised Monitor wound dressing to ensure it is fully compressed and firm to the touch Power inlet and power supply AC mains power inlet cii m Power supply with DC cord Indications for use RENASYS GO is indicated for patients who would benefit from a suction device Negative Pressure Wound Therapy as it may promote wound healing via removal of fluids including irrigation and body fluids wound exuda
38. icant air leak may occur in system without device activating a high flow leak alarm This may be due to partial blockage between source of air leak and device prohibiting detection of the leak by device resulting in no alarm activation Potential sources of blockage include e Physical occlusion in wound dressing coagulated blood or purulent material in filler compacted filler high volume viscous fluid e Physical occlusion in tubing kink in canister tubing clot in tubing e Soft Port aperture misaligned to dressing opening Check wound dressing regularly to ensure it is fully compressed and firm to the touch Page 2 of 3 H e iMedigas 385 Bentley St Praxair Canada Inc Markham ON L3R 972 MEDICAL DEVICE RECALL PRIVATE amp CONFIDENTIAL DEVICE CORRECTION NOTICE Delivered Via Registered Mail Date February 27 2015 Dear Customer Re Device Correction regarding RENASYS Devices Amended User Manuals Instructions For Use IFU Smith amp Nephew Inc Smith amp Nephew has notified Medigas division of Praxair Canada Inc Medigas of a device correction regarding Smith amp Nephew s RENASYS range of Negative Pressure Wound Therapy NPWT devices Smith amp Nephew has issued a Device Correction Notice to announce the implementation of amended User Manuals for the RENASYS Go 66800164 RENASYS EZ Plus 66800697 and RENASYS EZ Max 66801309 devices and amended Instructions For Use IFU for the RENA
39. ingle patient use 25 Carry bag available for 300ml canister To place the device into the carry bag 1 Open the zipper on both sides of bag and place face down on a flat surface with viewing flaps on top Place device face up on the open bottom section of the bag Pull front of the bag over top of the device and feed both parts of one zipper together Close zipper on the other side of the bag Once fitted ensure canister tubing can move freely gs nN PF ODN Excess tubing can be coiled and placed in the pouch on the back of the carry bag Flaps on the front of the bag provide privacy and discretion for the user On rear of the bag there is a belt loop should the user wish to wear RENASYS GO around their waist Note Device carry bag is designed to be a single patient use item a Belt loop Lifting top flap allows access to ium device user interface Canister tubing pouch Lifting bottom flap allows the canister to be viewed Note Device and canister should remain in an upright orientation to maximize canister volume and optimize complete blockage canister over capacity alarm 26 Maintenance Inspect device for visible signs of damage before each use If device has been dropped or shows signs of damage do not use Return damaged device to your Smith amp Nephew authorized representative There are no serviceable parts in the device Do not attempt to open device housing Contact your Smit
40. kage alarm turn device on and insert tethered cap of canister tubing into connector to simulate a blockage A functional device will activate a complete blockage alarm within 5 minutes In the case that complete blockage alarm does not activate check canister installation and contact your Smith amp Nephew authorized representative Removing or changing canister 1 Hold orange quick click connector above wound to help ensure exudate does not leak from tubing 2 Turn device off 3 Disconnect canister tubing from Soft Port 4 Insert tethered cap into both sides of orange quick click connector 5 Release orange canister clips on sides of canister and gently pull away from device eh Disposal of used canisters should follow A facility protocols or local ordinances M relating to handling of potentially sionazaro infected or biohazardous materials Connect RENASYS Soft Port dressing and canister Connect Soft Port to canister tubing by pushing orange quick click connectors together An audible click indicates connection is secure Note Do not cover aeration disc Disconnect RENASYS Soft Port dressing and canister 1 Hold orange quick click connector above wound to help ensure exudate does not leak from tubing Turn device off 3 Disconnect canister tubing from Soft Port M 4 Insert tethered cap into both sides of orange quick
41. kely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings Voltage fluctuations flicker emissions Comply used for domestic purposes IEC 61000 3 3 Harmonic emissions IEC 61000 3 2 Not Applicable WARNING The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the device should be observed to verify normal operation in the configuration in which it will be used Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz WI dz12P d 1 2 P d 2 34P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 10 12 12 2 3 10 3 8 3 8 73 100 12 12 23 For transmitters rated at a maximum ou
42. le alarm will sound continuously for 2 minutes Indicator 1 RECHARGE NOW BATTERY FAIL Charging 100 mmHg BATTERY FAILED mmHg 100 This feature is available with software version 0 66 and later Battery level After 2 minutes in an extremely low battery charge state device will power off When plugged into AC mains power display screen will show Charging message and battery status top indicator will flash green If battery unit within device has failed to charge display screen will show Battery Failed message and battery status bottom indicator will flash amber Note This will only display when connected to AC mains power Caution Keep device away from direct heat sources during charging EN Action Plug device into AC mains power No action required Device may take up to 3 hours to charge Therapy will only be delivered if plugged into AC mains power Device will not operate on battery power Contact your Smith amp Nephew authorized representative EN Troubleshooting Guide Cause Alarm status with display screen Remedy Low Vacuum Alarm LOW VACUUM Vacuum level is lower than NPWT set point by gt 15mmHg e Audible alarm will beep 3 times every 10 seconds Status alarm indicator light will flash amber Once corrected alarm will automatically reset and status alarm indicator will return to solid green AUDIO PAUSED o LOW VACUUM
43. n to solid green AUDIO PAUSED t LEAK e Pressing audio pause button will pause audible alarm for approximately 2 3 minutes There is a significant leak in the system This could include an air leak around the dressing or a poor seal at one of the connectors between the dressing Soft Port canister or device 22 1 With device actively creating vacuum check wound dressing for air leaks Look for loose or decompressed dressing appearance listen for air movement around dressing and feel for areas less compressed or cooler in temperature Address identified leaks with transparent film or adhesive gel patch 2 Ensure the following connections are secure e Orange quick click connector between Soft Port and canister tubing e Secure engagement of canister to device 3 Disconnect Soft Port from canister tubing at orange quick click connector and insert tethered cap into both connectors e If alarm condition continues there is a potential issue with the device or canister Replace canister and contact your Smith amp Nephew authorized representative e If alarm condition resolves an air leak is present within the wound dressing or Soft Port Reassess and replace as needed Note An air leak may result in a pressure drop occurring within the system As a result the low vacuum alarm may also activate while the high flow leak alarm is active Alarm status with display screen Cause Rem
44. ng around flames and sources of ignition Keep out of reach of children For external use only 28 29 EN As with all adhesive products apply and remove dressing carefully from sensitive or fragile skin to avoid blistering and skin stripping especially after frequent dressing changes Use of skin sealant may assist with protection of periwound skin If patient must be disconnected the ends of the RENASYS Soft Port and canister tubing should be protected using tethered caps to avoid leakage of fluid and cross contamination Physician orders Prior to placement of RENASYS CO the medical professional treating the wound must assess how to best use the system for an individual wound It is important to carefully assess wound and patient to ensure clinical indications for Negative Pressure Wound Therapy NPWT are met All orders should include Wound location size and type Smith amp Nephew wound dressing kit Pressure settings Frequency of dressing changes Adjunctive dressings EN Glossary of symbols Power Turns device ON and OFF Battery indication Shows status of device battery life Up selector Allows pressure setting to be increased and scroll through menu options Down selector Allows pressure setting to be decreased and scroll through menu options 0 o Keypad lock Locks keypad to restrict accidental adjustment of therapy When activated the light will illumina
45. o include the following Cautions for blockage alarms and leak alarms Caution Lack of Blockage alarm If partial blockage occurs the change in pressure status detected by device may not be significant enough to trigger alarm activation Over time if blockage reaches point of full occlusion complete blockage alarm will activate Blockage formation within the wound dressing will not be detected by the system as it has occurred outside of the monitored vacuum circuit but can affect pressure status at the wound Appropriately frequent monitoring of wound dressing is recommended to confirm adequate delivery of therapy In the event of heavy or viscous drainage drainage with sediment or when blood is present regular monitoring and more frequent dressing changes may be required If a complete blockage is present in the system but an air leak occurs between blockage and device the alarm may not activate Ensure all connections are secure and no air leaks are present in system Potential sources of air leaks include e Misplaced or worn O ring on the RENASYS GO device inlet port located between the device and canister e Partially inserted in line bacterial overflow guard on the RENASYS EZ EZ PLUS EZ MAX devices e Tear in Soft Port e Misplaced or worn O ring within the quick click connector between the Soft Port and canister tubing e Cracked or damaged canister Caution Lack of Leak alarm Under specific circumstances a signif
46. ound Therapy NPWT The frequency should be determined by the clinician based on individual characteristics of the patient and wound NPWT devices are not designed to detect or issue an alarm condition based on the presence of bleeding or pooling These conditions may only be detected by frequent monitoring Special attention to the risks of bleeding or loss of NPWT should be considered when prescribing for use in the Home Environment Page 1 of 3 red We are smith amp nephew NPWT may be impacted by various conditions related to system configuration set up and individual characteristics of the patient and wound e g exudate characteristics patient anatomy Alignment of the port to the opening in the drape use of a bridging technique and choice of dressing configuration based on wound characteristics may impact NPWT vacuum delivery over the course of therapy Exudate volume viscosity and consistency may influence fluid removal or occlusion formation A full canister incorrect canister orientation and device tubing height relative to the wound can contribute to loss of NPWT and exudate accumulation within the wound which could lead to maceration infection or unrecognised bleeding Monitor the wound for infection and ensure that all wound filler is removed at each dressing change to reduce the risk of infection Skin grafts should be closely monitored to ensure NPWT is being delivered The revised User Manuals IFU will als
47. ring patient must disconnect from device protecting both ends of RENASYS Soft Port tubing using tethered caps Ensure aeration disc located near quick click connector is free of moisture before reactivation of therapy to ensure proper alarm functionality and prevent interruption in therapy If any liquids penetrate device discontinue use and return to your Smith amp Nephew authorized provider for service CT scans and x ray have the potential to interfere with some electronic medical devices Keep device out of x ray or scanner range Use caution if device is used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide AC mains power can only be removed by disconnecting power cord or AC power adaptor Take care in positioning the device to allow access to cord receptacle If power cord is damaged wires are frayed or exposed do not use power cord Contact your Smith amp Nephew representative for a replacement cord Canisters should be changed at least once a week whenever there is a change in patient or in the event that canister contents reach maximum volume indication 300ml or 750ml fill line Do not wait for the canister over capacity alarm to activate to change canister Canisters kits are single use devices Do not reuse Do not apply SECURA No sting barrier film wipes directly to open wounds SECURA No sting barrier film is flammable Use in a well ventilated area Avoid usi
48. t hand corner of the welcome display screen Starting therapy 1 Select prescribed pressure setting using Up 4 and Down y buttons 2 Press Select I gt button to start therapy Continuous 100 mmHg 3 Finished dressings should be fully compressed firm to the touch and leak free Setting pressure level is a decision that the healthcare provider must make based on an individual assessment of the particular wound 40 120mmHg is recommended therapeutic pressure range In the event you have a wound that is difficult to seal you may increase the pressure setting to achieve desired negative pressure at the wound bed Device will show set pressure level If device detects operation outside of the set pressure it will result in alarm activation Caution Before starting therapy ensure that device and system tubing are located no more than 19in or 50cm higher than the wound and is away from any direct sources of heat EN Pause adjust therapy Therapy may be paused by pressing Select Ib button once When paused device will show a standby message on display screen and pressure setting can be changed using Up 4 and Down y buttons Standby gt 100 mmHg Press Select I gt button to restart therapy Lock or unlock keypad To lock user interface when device is active press and hold Keypad Lock B button for 2 seconds When activated the light will illuminate solid blue Locked mmHg Keypad 100
49. te solid blue o Audio pause Pauses alarm for approximately 2 3 minutes When activated the light will illuminate and flash yellow If a new alarm occurs the audio pause will cancel This feature available with software version 0 66 and later Start pause therapy and select Starts or pauses therapy It is also used to confirm settings within therapy Equipment Single Use IEC REP European Classification Do not reuse Representative Isolation type BF applied part GP CSA International b Keep Dry Lot Number cus Classification X EU sses Storage Temperature SN Serial Number Not for general waste c EN Lu Refer to instruction Date of Manufacture Product Catalogue manual booklet mi Number Caution Manufacturer C CE Mark Follow instructions for ise 0297 Caution U S Federal amp Do not use if package is MA MRI Unsafe R only law restricts this device to sale by or on the damaged order of a physician Dressing changes Refer to instructions for use provided with dressing kits for additional information on dressing use and maintenance 1 Foam dressings should be changed every 48 to 72 hours after the initial application of therapy If no leak is present and the patient is comfortable subsequent dressing changes should occur no less than 3 times per week 2 Gauze dressings should be changed 48 hours after the initial application of therapy If no leak is present and the patient is comfortable su
50. tes and infectious materials Appropriate wound types include e Chronic e Acute e Traumatic e Sub Acute and dehisced wounds e Ulcers such as pressure or diabetic e Partial thickness burns e Flaps and grafts EN Contraindications Use of RENASYS GO is contraindicated in the presence of e Untreated osteomyelitis e Exposed arteries veins organs or nerves Necrotic tissue with eschar present e Malignancy in wound with exception of palliative care to enhance quality of life e Non enteric and unexplored fistulas e Anastomotic sites Warnings 1 Carefully monitor patients for signs of bleeding which may lead to interruption in therapy and hemodynamic instability If such symptoms are observed immediately discontinue therapy take appropriate measures to control bleeding and contact treating clinician 2 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 3 Do not use directly on exposed blood vessels or organs 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 4 NPWT has not been studied on pediatric patients Patient size and weight should be considered when prescribing the device 5
51. tput power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 29 EN Specifications Pressure Setting 40 50 60 70 80 90 100 120 140 160 180 200mmHg tolerance 10 mmHg Maximum 200mmHg Power requirements Device input voltage 21 VDC Device input power 36 Watts Mains adapter Smith amp Nephew REF 66800161 Input 100 240VAC 50 60HZ 0 9A Output 21VDC 1 71A 36W Fuses Internal electronic fuse not user changeable Power cord Length 4 5m maximum Class Dimensions 7 x 8 3 x 3 5in 175 x 210 x 85mm Weight 2 4lbs 11 kg Battery Operating time 20 hours therapy Type Lithium ion Charging time 3 hours Safety protection Protection against electric shock Class Patient protection Type BF Ingress protection IP2X Environmental Storage and transport Operational temperature Relative humidity Atmospheric pressure 14 to 131 F 10 to 55 C 41 to 95 F 5 to 35 C 30 to 70 RH 700 mbar to 1 060 mbar Compliance Standards
52. xia discontinue use of NPWT and immediately seek medical assistance When treating enteric fistulas do not place NPWT dressing in direct contact with exposed bowel Cover the wound bed including fistula opening with non adherent gauze or with one layer of saline moistened gauze During the course of treatment patient s fluid levels must be closely monitored Avoid use of circumferential dressings except in cases of oedema or heavily exuding extremities where this technique may be necessary to maintain a seal Consider using multiple drapes to minimize risk of decreased distal circulation Regularly assess distal pulses and discontinue therapy if changes in circulation are detected Monitor patient for any signs of local or systemic infection Infected wounds may require more frequent dressing changes As NPWT is not intended to directly treat infection if there are any signs of systemic infection or advancing infection at wound area contact treating clinician immediately If multiple pieces of foam or gauze are needed to fill the wound profile count and record how many pieces are present to ensure all pieces are removed at a dressing change to minimize the risk of retention and possible infection NPWT should remain on for duration of treatment The length of time a patient may be disconnected from device is a clinical decision based on individual characteristics of patient and wound Factors to consider include location o
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