VERSAJET™ II *smith&nephew
Contents
1. any sharp instrument care and attention must be maintained while using the VERSAJET II Plus handpieces near delicate vessels and structures VERSAJET II is intended primarily for use in the operating room environment Only the 45 degree VERSAJET Il Exact handpieces 66800041 and 66800042 are suitable for use outside the operating room Attention to universal infection control procedures should be applied when using the device outside the controlled environment of the operating room The 15 degree 144mm VERSAJET Il Exact handpiece 66800040 and all of the VERSAJET II Plus handpieces 66800043 66800044 and 66800045 should not be used outside the operating room due to the potential of excessive misting or spraying If the VERSAJET Il Exact 45 degree handpieces are used outside the operating room ensure the floor immediately surrounding the treatment area is covered and any splashes cleaned after treatment is complete Precautions Always begin debridement procedures at the lowest power setting and increase as necessary to the optimal setting for the type of tissue being debrided to avoid unintended tissue removal In order to avoid unwanted procedural delays assure the system is fully operational prior to administration of anesthesia When used on wounds where bone tendon or other hard tissue may be encountered during the debridement procedure excessive spraying and or misting may occur due to the interruption of the s2. Single use handpiece assembly System Console 66800039 Do NOT attempt to The VERSAJET II single use handpiece assembly is a connect to any other equipment sterile device and should be disposed of after use The handpiece has an operating window located at the instrument s distal tip When the system is in operation a stream of pressurized saline travels across the opening and creates a localized vaccum effect By applying passing the operating window over the debridement area the user can excise non viable tissue and contaminants OO O BB Ww 7 Instrument tip the metal tip with a small precise opening where a high velocity stream of sterile saline selects and excises non viable tissue and contaminants contained in the operating site the instrument tip contains the evacuation oriface Handpiece an ergonomic handle supporting the instrument tip receives the high pressure line and waste evacuation line at the proximal end white Inflow tube a clear tube with white spike and pinch clamp that connects to a saline bag Pump cartridge couples with the pump interface on the console orange High pressure tube a tube that carries pressurized saline to the distal tip of the handpiece Waste evacuation tube a clear tube with a blue connector end that carries evacuated fluid non viable tissue and contaminants to an appropriate waste container Clam shell a clear plastic enclosure that holds th
3. also available for download at wwwversajet info Cleaning Follow your healthcare facility s standard procedures for decontaminating surgical equipment to decontaminate the console footswitch and power cord The following are the recommendations for console decontamination Wear protective gloves gown and eye wear Wipe all surfaces of the console and footswitch with a disposable towel or cloth soaked in the disinfectant solution Sporicidin Disinfectant 1 12 glutaraldehyde 1 93 phenol phenate or an equivalent high level disinfectant is recommended Dilute the disinfectant solution according to the manufacturer s instructions After disconnecting the footswitch and power cord from the console wipe down all exposed surfaces of both components in accordance with the guidance for the console Dispose of towels gloves and gown in accordance with your healthcare facility s standard guidelines for biohazardous waste disposal or as prescribed by the environment in which the console was used This procedure should be performed after each console use Disposal of the console and accessories At the end of the console s useful life it should be disposed of in accordance with local laws and regulations For compliance with the Waste Electrical and Electronic Equipment WEEE Directive 2002 96 EC equipment that has reached the end of its useful life may be returned to equipment manufacturer Please contact Customer Care at 1 8
4. pump interface setting standard tool is locked in the 3 o clock position Verify the amber footswitch connection LED is e ON when the footswitch connector is not inserted into the footswitch socket e OFF when the footswitch connector is inserted smith amp ne O 7 Illuminated green light ring indicates positive handset engagement interfaces and secures the handpiece pump assembly to the console 9 Key lock symbols directs user to the open UNLOCKED and the closed LOCKED handpiece pump positions Console speed check 5 Aim the tachometer optical beam so that the 1 Insert the speed stick until fully seated into the reflector on the speed stick produces an RPM opening of the pump interface reading 6 Measure speed specification 425 50RPM 7 Set the console to the highest power setting of 10 3 Set the console to the lowest power setting of 01 8 Depress and hold the footswitch DOWN to allow the console to cycle its motor transmission A 9 Aim the tachometer optical beam so that the reflector on the speed stick produces an RPM reading Vv 4 Depress and hold the footswitch DOWN to allow the console to cycle its motor transmission 10 Measure speed specification 1290 100RPM 24 Safety check procedure Electrical testing check Connect console to electrical outlet AC mains Connection to mains grounding is accomplished through use of the grounding po
5. tissue removal Monitor fluid level of waste container and empty as needed Subsequent debridement procedures may be necessary for complex or highly contaminated wounds Do not touch the high pressure jet in the operating window of the handpiece Use only sterile saline solution with this device Examine all components before use If you believe a component to be faulty damaged or suspect DO NOT USE Contact your local Smith amp Nephew VERSAJET Il representative Pre heating saline prior to use with VERSAJET Il is not recommended Due to the use of high pressure some heating of the saline will occur during use The higher the console power setting the more pressure being applied with the handpiece tip or the longer the saline jet is in contact with the wound area the greater the possibility of unintended tissue damage e Federal USA law restricts this device to sale by or on the order of a physician Each VERSAJET II disposable handpiece is intended for SINGLE USE ONLY DO NOT RE STERILIZE Discard after use The VERSAJET Il handpieces are not designed to withstand the rigors of reprocessing or re sterilization device performance will be compromised and sterility can not be assured Refer to our company position regarding the reprocessing and reuse of single use only medical devices in Appendix A of this manual or visit our website wwwversajet info System components The VERSAJET Il system consists of
6. voltage to the patient applied part relative to the protective earth conductor Important note The VERSAJET Il console is NOT user serviceable and under no situation should the casing be opened Any attempt to open the unit by the user will void all warranties and render the user responsible for all subsequent repairs to the unit Contact your local Smith amp Nephew customer care representative or sales representative to resolve all console problems 26 Physical appearance check Caution console is unplugged and placed on bench for this step Step Yes No Comments 1 Check console for visible dents cracks and missing pieces 2 Check that ventilation slots are free from obstructions dust or foreign materials 3 Check that labels and markings are intact and legible with no smudges 4 Check that the pump interface rotates between lock and unlock positions and remains in place 5 Check footswitch and attached cable for signs of damage or missing insulation 6 Check footswitch mechanicals for system activation by depressing and releasing 7 Inspece UP DOWN power controls for excessive wear 8 Inspect power cord for any frayed or missing insulation and bent loose or missing plug blades or earth ground System diagnostics check Note console is plugged in and placed on bench for this step 9 Adjust main power switch to ON OFF positions verify illumination status when ON 10 Verify that
7. 00 876 1261 USA only or local Smith amp Nephew representative to return a console for repair or replacement Troubleshooting guide Symptom No intermittent electrical power Footswitch LED Console not responding to footswitch and footswitch connector indicator is NOT illuminated System fault LED illuminated Cause Power cord not connected or connected loosely at console or electrical outlet Note The console will default to power level 1 if power is interrupted Power not present at electrical outlet Console power switch not illuminated Footswitch not connected properly Footswitch obstructed Footswitch inoperative Power fault caused by over current System over pressure condition out of tolerance Remedy Ensure that power cord is 1 2 Fully seated into the back of the console and electrical outlet Not damaged and free of defects For replacement power cord contact Customer Care at 1 800 876 1261 USA only or local Smith amp Nephew representative Ensure that the electrical outlet has power Connect to a different electrical outlet Press power switch power switch should become illuminated Observe red alignment dots on footswitch connector and footswitch socket are properly aligned Ensure the footswitch connector is fully inserted Ensure that there are no objects obstructing the footswitch from being depressed or releasing Order replacement footswitch 66800472 f
8. ERSAJET Il Hydrosurgery System uses RF energy only CISPR 11 me so for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby RF emissions CISPR 11 Class A electronic equipment Harmonic emissions PsA eee IEC 61000 3 2 The VERSAJET Il Hydrosurgery System is suitable for use in hospital establishments and those directly connected to Voltage fluctuations flicker emissions i de Sear awai supply network that supplies IEC 61000 3 3 Complies uildings used for industrial purposes WARNING The VERSAJET II Hydrosurgery System should not be used adjacent to or stacked with other electrical equipment and that if adjacent or stacked use is necessary the VERSAJET Il Hydrosurgery System 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 VERSAJET II Hydrosurgery System 66800039 The VERSAJET Il Hydrosurgery System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of The VERSAJET Il Hydrosurgery System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and The VERSAJET Il Hydrosurgery System as recommended below according to the maximum output power of the communications equipmen
9. VERSAJET Il Hydrosurgery System ev gyen Wy C User guide Table of contents Indications Safety Warnings Precautions System components Console Front panel layout Footswitch Back panel layout Handpiece components Single use handpiece asssebly Handpiece options System set up Console set up Connecting the footswitch Power cord socket Turning the console ON Handpiece quick set up pictorial guide Single use handpiece set up and system priming Console maintenance and cleaning Maintenance Cleaning Disposal of the console and accessories page number BR B SD y oo O gt K smith amp nephew VERSAJET Il Hydrosurgery System Troubleshooting guide Glossary of symbols Technical information System specifications Console front panel Console rear panel Product dimensions and weights Single use handpiece environmental conditions Console environmental conditions Electromagnetic compatibility Warranty Appendix Company position regarding the reprocessing and reuse of single use only medical devices Appendix B Ordering information Appendix C Console performance and safety check Global Customer Service 21 22 263 Indications The VERSAJET Il Hydrosurgery System is intended for wound debridement acute chronic wounds and burns soft tissue debridement and cleansing of the surgical site in applications that in the physician s judgm
10. drosurgery System or for additional customer assistance please refer to the Smith amp Nephew Customer Care Details below Australia Smith amp Nephew Pty Ltd Tel 61 3 8540 6777 315 Ferntree Gully Road Fax 61 3 9544 5086 PO Box 242 Mount Waverley Victoria 3149 Austria Smith amp Nephew GmbH Tel 43 1 70 79102 Concorde Business Park C3 Fax 43 1 70 79101 Osterreich info austria smith nephew com A 2320 Schwechat Belgium Smith amp Nephew SA NV Tel 32 2 702 2911 Kareelovenlaan 3b Fax 32 2 726 1035 1140 Brussel info be smith nephew com Canada Smith amp Nephew Inc Tel 1 800 463 7439 2250 Alfred Nobel Boulevard Fax 1 800 671 9140 St Laurent Quebec H4S 2C9 Denmark Smith amp Nephew A S Tel 45 4580 6100 Slotsmarken 14 Fax 45 4580 6151 2970 Hoersholm sn dk smith nephew com Finland Smith amp Nephew Oy Tel 358 0 207 866 300 Ayritie 12 C Fax 358 0 207 866 320 01510 Vantaa France Smith amp Nephew SAS Tel 33 02 43 83 23 82 Espace Novaxis 33 02 43 83 24 14 25 Blvd Marie et Alexandre Oyon Fax 33 02 43 83 23 83 72019 Le Mans Cedex 2 scw smith nephew com Germany Smith amp Nephew GmbH Tel 49 040 87 97 44 0 Wound Management Fax 49 040 87 97 44 375 Osterbrooksweg 71 info smith nephew com D 22869 Schenefeld Italy Smith amp Nephew Tel 800 393 060 numero verde attivo 8 30 18 00 Wound Management 039 6094223 6094224 Via de Capitani 2A Fax 039 6094274 20041 Agrate Brianza MI Centro Assistenza Client
11. e orange pump cartridge in clam shell tray and waste evacuation line to the circulator nurse for final system set up The circulator nurse should remove the orange pump cartridge from the clam shell and insert into the pump interface located on the front of the console until fully seated and then turn clockwise to the 3 o clock position When locked correctly the circular light surrounding the pump interface should illuminate green CAUTION Only insert the saline bag spike AFTER the orange pump cartridge has been securely locked in the console Failure to do so may result in fluid leakage from the pump cartridge Remove sterile cover from bag spike and insert into sterile saline supply bag Ensure that the clip on the saline inflow line is open Note The saline bag MUST be a minimum of 24in 60cm above the console for the system to prime Attach end of waste evacuation tubing blue tip to waste container DO NOT connect to a port containing a filter or to the port labeled VACUUM You must ensure that there is an additional open port on the waste containers lid Ensure there are no kinks or other external obstructions in saline supply high pressure and waste evacuation hoses 9 Insert the footswitch connector into the footswitch socket on the front of the console until the connector locks in place The red dot on the footswitch connector should be aligned with the red dot on the footswitch socket Position the footsw
12. e VERSAJET Il Hydrosurgery System requires continued operation during power mains interruptions it is recommended that the VERSAJET Hydrosurgery System be powered from an uninterruptible power supply or battery Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 NOTE U_is the AC mains voltage prior to application of the test level Power frequency Power frequency magnetic fields should be at 50 60 Hz magnetic field 3 A m levels characteristic of a typical location in a IEC 61000 4 8 typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any part of the VERSAJET Il Hydrosurgery System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2vP d 1 2VP 80 MHz to 800 MHz Conducted RF 3 Vrms avers d 2 3VP 800 MHz to 2 5 GHz IEC 61000 4 6 150 kHz to 80 MHz where P is the maximum output power rating of the transmitter in watts W according to Radiated RF 3 V m ai the transmitter manufacturer and d is the IEC 61000 4 3 80 MHz io 2 5 GHz recommended separation distance in metres 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 equipm
13. e condition e fa fault occurs the console should be sent back to the manufacturer for service DO NOT attempt to open the unit to perform repair Footswitch pedal depressing the footswitch pedal activates the cutting jet UP toe button depressing the toe button next to the UP arrow increases the power setting DOWN toe button depressing the toe button next to the DOWN arrow decreases the power setting Footswitch connector connects the footswitch to the footswitch socket on the console Footswitch cable connects the footswitch connector to the footswitch Rear panel layout gt y smith amp nephew VERSAJET II 66800039 Hydrosurgery Console 100 240 V 50 60Hz pri 600W T6 34 250v 2011 R only A a K CE 0 Lake Cari ademark of Marque de commerce de Smith amp Nephew om LA02854 D 1 Input power cord socket interfaces with the detachable power cord through a three prong socket e The power cord provides electrical power to the console from an electrical outlet For details of available power cords please refer to the Ordering Information section 2 Protective earth ground terminal equipotentiality allows connection to the main system ground for testing the equipment 3 Device label contains information and symbols specific for device Hand piece components WARNING The VERSAJET Il handpiece is designed for connection only to the VERSAJET II Hydrosurgery
14. e following conditions apply for product use as well as shipping and Power cord Detachable hospital grade power handling cord with C13 plug Power input 100 240 VAC rating 600 W Lu 50 60 Hz Shipping and handling Product use 50 F 10 C to 90 F 32 C Humidity range 10 to 90 non condensing Temperature range 40 F 40 C to 125 F 52 C Fuse ratings Dual slo blo type T6 3A 250 VAC 5 x 20 mm fuses Mode of Continuous operation Atmospheric pressure 700 to 1060 hPa Applied part Type BF classification Console environmental conditions Equipment Class classification Unless otherwise stated the following conditions Compliance IEC 60601 1 apply for product use as well as shipping and UL 60601 1 handling CAN CSA C22 2 No 601 1 Temperature Shipping and handling Product use 50 F 10 C to 90 F 32 C Humidity range 10 to 90 non condensing 4 F 20 C to 131 F 55 C Atmospheric pressure 700 to 1060 hPa Electromagnetic compatibility This equipment has been tested and found to comply with the limits for medical devices to IEC 60601 1 2 2001 These limits are designed to provide reasonable protection against harmful interference 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 devices in the vicinity However there is
15. e handpiece and pump cartridge Handpiece options The VERSAJET Il handpiece is available in two styles Exact and Plus VERSAJET Il Exact handpieces VERSAJET II Plus handpieces Order no Description Order no Description VERSAJET Il Exact mm VERSAJET II Plus 66800040 disposable handpiece ee 66800043 disposable handpiece 15714mm m 1514mm VERSAJET II Exact Ae VERSAJET II Plus 66800041 disposable handpiece 4 4 66800044 disposable handpiece 45714mm 4 h 45 14mm i VERSAJET Il Exact l VERSAJET II Plus 66800042 disposable handpiece y 66800045 disposable handpiece 458mm Ha 45 8mm ee Lower deck height Higher deck height EE Narrower channel Wider channel System set up This section provides the procedures for set up and operation of the VERSAJET Il system CAUTION Before connecting the device to an electrical outlet ensure that you have selected the appropriate power cord for the local power requirements and that the device is connected to a socket that meets the system requirements Failure to do so may cause damage to the equipment and void the warranty Console set up Connecting the footswitch Connect the footswitch connector into the footswitch socket on the front of the console ensuring the red dots on the connector and socket are aligned Position the footswitch for convenient access Power cord socket Insert the female end of the power cord into th
16. e of manufacture STERILE EO Method of packaging do not contain sterilization natural rubber latex Do not use if package is ML Protect from direct Fuse PAS damaged AN sunlight Equipotentiality Green point UK Footswitch protective grounding connection R l Federal USA law CE mark RoHS compliant only restricts this device to 0086 sale by or on the order of sis a physician Technical information Contact Customer Care at 1 800 876 1261 USA only or local Smith amp Nephew representative to return CAUTION Only VERSAJET Il system equipment should console for repair or replacement be connected to the console There are no user serviceable parts within the console All required service must be performed by the manufacturer System specifications Product dimensions and weights Front panel Size 15in W x 11 8in D x 5 8in H 38 1cm W x 30cm D x 14 8cm H IP classification IPXI pootewtteh Size 7 5in W x 7 25in D x 2in H L Unlock position for pump 19cm W x 18 4cm D x 5cm H cartridge Weight 3lbs 1 1kg we Amber footswitch indicator light Cord length 15ft 4 6m A Red fault indicator light IP classification IPX8 Prior to connecting the device to an electrical Length 15ft 4 6m outlet determine local voltage and electrical supply requirements Ensure the cable is compatible Power inlet IEC60320 1 C14 style power inlet with dual fuse holder Single use handpiece environmental conditions Unless otherwise stated th
17. e three prong socket on the back of the console Connect the other end of the power cord to an appropriate electrical outlet Turning the console ON Press the power switch The display will illuminate to indicate that power is supplied CAUTIONS Do NOT block the air vents on the bottom of the console Air vents allow circulating air to cool the console After each use thoroughly clean the console footswitch and power cord Please refer to the Cleaning and Maintenance section Handpiece quick set up pictorial guide Single use handpiece set up and system priming Remove the pouch from carton Inspect pouch to ensure seals are intact and pouch is undamaged Open the pouch ensuring that the sterility of the inner pouch is not compromised Aseptically transfer inner pouch and contents to the sterile field Note Chart labels are on the outer pouch Inspect inner pouch to ensure seals are intact and pouch is not damaged Open inner pouch remove the sterile contents and place securely in the Sterile field Avoid tangling and knotting of hoses Remove white handpiece from clam shell and place in sterile field Do not remove pump cartridge orange handle from clam shell tray Remove the white paper tape from coiled tubing Uncoil the various tubing lines Maintain aseptic technique for the white handpiece and several feet of tubing to allow access to the surgical site Hand off the inflow tub
18. ent require sharp debridement and pulsed lavage irrigation Safety The VERSAJET Il system is designed for use by qualified and trained medical professionals It is recommended to study this user guide paying particular attention to all Warnings and Precautions prior to any surgical procedure Improper system use or set up or failure to follow this user guide may cause injury or damage not covered under the warranty Warnings e This device should be used with particular care in patients with hemophilia or other blood clotting disorders and in patients receiving anti coagulant medication This device can cut soft tissue Apply only to tissues and debris intended to be excised from the wound This device is not suitable for use in the presence of a flammable anaesthetic mixture with air or oxygen Increasing console power settings will lead to more aggressive tissue removal Use caution near delicate vessels and structures such as neurovascular bundles The VERSAJET II handpieces are designed for connection only to the VERSAJET Il system console DO NOT attempt to connect to any other equipment The VERSAJET II Plus handpieces provide more aggressive debridement and excision when compared to the VERSAJET Il Exact handpieces VERSAJET II Plus is appropriate for wounds that require aggressive yet selective removal of tissues that are tough heavily necrotic contaminated or burnt Users should be aware that just as with
19. ent marked with the following symbol fr a iae NOTE 1 At 80 MHz 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 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 VERSAJET Il Hydrosurgery System is used exceeds 3V m the VERSAJET II Hydrosurgery System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the VERSAJET Il Hydrosurgery System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 18 Guidance and Manufacturer s declaration electromagnetic emissions The VERSAJET Il Hydrosurgery System 66800039 is intended for use in the electromagnetic environment specified below The customer or the user of the VERSAJET Il Hydrosurgery System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidelines RES Group 1 The V
20. g multi use systems with single use patient contact components it is our position that these devices are not designed or manufactured to withstand the rigors of reprocessing and therefore should not be reprocessed Single use medical devices are intended to be used on an individual patient during a single procedure and then discarded They are not intended to be reprocessed and used again Labeling identifies such devices as single use and is not intended to be reprocessed and used again The use of reprocessed devices may present unacceptable risks to the health and safety of patients and healthcare professionals Tissue and organ damage as well as cross infection can result from the reuse of a single use device because of practical issues of cleaning single use devices Moreover the rigors of reprocessing can impair the performance and adversely affect the safety of a single use device as a result of changes in the physical state of the device Appendix B Ordering information 66800039 VERSAJET Il console e includes footswitch power cord and user manual 4mm 4mm 5 45 45 8mm 5 14mm 45 14mm 45 8mm 1 1 66800044 VERSAJET II Plus handpiece 66800045 VERSAJET II Plus handpiece 66800472 VERSAJET II multi function footswitch 66800303 Power cord Australia New Zealand To order contact Customer Care at 1 800 876 1261 USA only or local Smith amp Nephew representative 21 Appendix C Co
21. he sales order This warranty does not cover i Products packaged or labeled by someone other than Smith amp Nephew or its authorized agents ii Products not used in compliance with the specifications in the product manuals iii Products used in conjunction with single use handpieces used more than one time iv Products used in conjunction with expired single use handpieces v defects due to misuse reprocessing alteration unauthorized repair or negligent handling or defects due to lack of care by the Customer or assigned user of the Product including but not limited to storage handling or cleaning OTHER THAN THE WARRANTY STATED ABOVE SMITH amp NEPHEW INC MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE MERCHANTABILITY OR FITNESS OR SUITABILITY FOR ANY PURPOSE OR USE BY CUSTOMER OF THE PRODUCT IN NO EVENT SHALL SMITH amp NEPHEW INC BE LIABLE FOR ANY ANTICIPATED PROFITS OR OTHER INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER OR LOSS OF TIME INCURRED BY THE CUSTOMER WITH THE PURCHASE OR USE OF THE PRODUCT FURTHER SMITH amp NEPHEW INC SHALL IN NO EVENT BE LIABLE FOR ANY EXEMPLARY OR PUNITIVE DAMAGES 20 Appendix A Company position regarding the reprocessing and reuse of single use only medical devices As a manufacturer of single use medical devices includin
22. i milan LOGCSM smith nephew com Ireland Smith amp Nephew Tel 01 276 9700 Oxygen Care Ltd Fax 01 276 4970 2 Holfeld Business Park orders oxygen care ie Kilmacanogue 24 hour clinical support line Co Wicklow lreland 01 217 0484 lreland Netherlands New Zealand Norway Portugal South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom United States Smith amp Nephew B V Postbus 525 2130 AM Hoofddorp Bezoekadres Kruisweg 637 2132 NB Hoofddorp Smith amp Nephew Limited PO Box 442 Shortland Street Auckland 1140 Smith amp Nephew A S Postboks 224 1379 Nesbru Bes ksadresse Nye Vak svei 64 1395 Hvalstad Smith amp Nephew Lda Estrada Nacional n 10 Km 131 Parque Tejo Bloco C 2626 445 Forte de Casa Vila Franca de Xira Portugal Smith amp Nephew Pty Ltd PO Box 92 Pinetown 3600 Smith amp Nephew SA Fructu s Gelabert 2 y 4 08970 Sant Joan Desp Barcelona Smith amp Nephew AB Kr ketorpsgatan 20 PO Box 143 431 22 M nldal Smith amp Nephew AG Glutz Blotzheim Strasse 1 4502 Solothurn Smith amp Nephew FZE Level 4 National Bank of Abu Dhabi Building Dubai Health Care City PO Box 9715 Dubai Smith amp Nephew Wound Mangement Healthcare Ltd Healthcare House 101 Hessle Road Hull HU3 2BN Smith amp Nephew Inc 970 Lake Carillon Drive St Petersburg FL 33716 Tel 020 654 39 99 Fax 020 653 20 99 holland info smith
23. itch for convenient access 10 Insert the female three prong plug of the power cord into the back of the console and the other end into an electrical outlet Press the power switch located on the front of the console 11 Remove the protective cover from the tip of handpiece 12 While holding the handpiece at a safe distance set the console power setting to 10 Depress the footswitch and keep the system running until saline reaches the distal tip of the handpiece An audible hissing sound and a visible saline jet aimed down the evacuation oriface indicates the system is primed Priming takes approximately 30 seconds Release the footswitch and reduce the power setting to 1 before use 13 CAUTION Once the system has been primed with saline do not allow the saline bag to empty An empty bag can cause air to enter the system and require re priming of the system Tubing should be clamped when changing saline bags 14 Begin debridement procedures starting at the lowest power setting and increase as necessary to the optimal power setting for the type of tissue being excised or debrided 15 If the evactuation oriface becomes blocked with foreign matter a reduction in device efficiency or the presence of spray from the insturment tip may result To eliminate the obstruction remove the handpiece from the wound site release the footswitch and remove the obstruction with forceps Do not touch the opening in the high pressure jet
24. k instructions verify the RPM is 1290 100 Electrical equipment safety check Note console is plugged in and placed on bench for this step e A meter capable of measuring micro amps is required 24 Power ON console by pressing illuminated power switch 24 Attach test leads to ground plug and pump interface as per electrical testing instructions Take readings as per electrical testing instructions to check if leakage is occurring Table 2 26 Disconnect test leads and power OFF by pressing illuminated power switch 25 27 Unplug power cord from electrical outlet and from rear panel of console Summary of results 28 Overall physical appearance showed no anomalies and unit is clean 29 Basic functional setup indicates functions evaluated are operational 30 Console speed verification meets specification as defined in test protocol 31 Electrical equipment safety testing indicates readings meet requirements e Please photocopy this page when performing the checklist so that you will always have a blank copy If any of the Summary Results are NO this could be an indication of a need for Service or Repair e Please contact your Smith amp Nephew Customer Care representative immediately at 1 800 876 1261 USA only e Have this report available at time of call Page intentionally left blank Customer Assistance For more information regarding VERSAJET Il Hy
25. nephew com Tel 64 9 828 4059 Fax 64 9 820 2866 Tel 47 66 84 20 20 Fax 47 66 84 20 90 norway smith nephew com Tel 351 21 446 0650 Fax 351 21 446 0679 Tel 27 0 31 242 8111 Fax 27 0 31 242 8120 Tel 34 93 373 73 01 Fax 34 93 373 7453 Tel 46 31 746 58 00 Fax 46 31 87 05 32 Tel 41 32 624 56 60 Fax 41 32 624 56 81 Tel 971 4 429 9111 Fax 971 4 429 9100 Tel 01482 222200 Fax 01482 222211 npwtorders uk smith nephew com 24 hour Clinical Support Line UK 0845 120 0167 Tel 1 800 876 1261 Fax 727 392 6914 customercare largo smith nephew com 1 866 998 NPWT 6798 Wound Management Smith amp Nephew Inc 970 Lake Carillon Drive St Petersburg FL 33716 Smith amp Nephew Medical Ltd EC REP hu Hus 28N England CE 0086 www smith nephew com www versajet info www globalwoundacademy com Customer Care Center 1 800 876 1261 T 727 392 1261 F 727 392 6914 only 2011 Smith amp Nephew Trademark of Smith amp Nephew PI03485 Certain marks Reg US Pat amp TM Off 07 2011 0 4056 66800474 J 12549 7
26. no guarantee that interference will not occur in a particular installation Guidance and Manufacturer s declaration electromagnetic immunity The VERSAJET Il Hydrosurgery System 66800039 is intended for use in the electromagnetic environment specified below The customer or the user of the VERSAJET Il Hydrosurgery System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge P TER EE sekcia Floors should be wood concrete or ceramic tile ESD 48 kV air 48 KV air If floors are covered with synthetic material the IEC 61000 4 2 E a relative humidity should be at least 30 Electrical fast transient 2 kV for power supply lines 2 kV for power supply lines burst IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge 1 kV differential mode 1 kV line to line Mains power quality should be that of a typical IEC 61000 4 5 2 kV common mode 2 kV line to earth commercial or hospital environment lt 5 U gt 95 dip in U for 0 5 cycle gt 95 for 10ms 40 U 60 dip in U for 5 cycles 60 for 100ms 70 U 30 dip in U for 25 cycles 30 for 500ms lt 5 U gt 95 dip in U for 5 sec gt 95 for 5000ms Mains power quality should be that of a typical commercial or hospital environment If the user of th
27. nsole performance and safety check Purpose The purpose of this procedure is to provide a performance and safety check for the VERSAJET II console 66800039 Important note The VERSAJET Il console is NOT user serviceable and under no situation should the casing be opened Any attempt to open the unit by the user will void all warranties and render the user responsible for all subsequent repairs to the unit Contact your local Smith amp Nephew Customer Care representative or sales representative to resolve all console problems Scope This procedure is applicable to the VERSAJET II console as a reference guide for customers and service providers wishing to perform performance checks Refer to the VERSAJET II Hydrosurgery System manual for additional information on the correct use of the console and its specifications Equipment Table 1 Ametek 1726 or equivalent hospital is responsible for purchase Electrical testing hospital responsible for equipment purchase RPM verification tool speed stick Optical tachometer Smith amp Nephew part number 15SN 0089 contact your local sales representative Pump interface Smith amp Nephew part setting standard tool number 15SN 0099 VERSAJET Il footswitch Smith amp Nephew part number 66800472 VERSAJET II Smith amp Nephew part Hydrosurgery System number 66800474 manual 22 Performance check procedure A checklist is provided at the end of this d
28. ocument to record the results of the following checks Physical appearance check 1 Make sure console is unplugged from electrical power Check console for visible dents cracks or missing pieces Inspect console and fan ventilation slots located on the bottom of the instrument Remove obstructions dust or foreign materials using vacuum and or disposable wipes Inspect console labels and markings for legibility and partial or missing labels Using the pump interface setting standard tool ISSN 0099 check that the pump interface rotates freely between UNLOCK and LOCK position and back to UNLOCK Check footswitch and footswitch cable for signs of exposed wires loose or missing insulation Check footswitch mechanical operation for engage and disengage by depressing the footswitch pedal and releasing Inspect the UP DOWN toe buttons for excessive wear Inspect power cord for any frayed or missing insulation bent loose or missing plug blades or earth ground System diagnostics check 1 Make sure console is plugged into an electrical outlet Press the illuminated power switch to the ON position and verify that the switch is illuminated and green in color Verify the light extinguishes with the switch in the OFF position Press the power switch to the ON position When power is turned ON the VERSAJET II console will perform the following visual sequence for you to verify that system indicator s a
29. re operating properly 4 a Verify that the footswitch connection LED indicator flashes amber ON OFF b Verify that the system fault LED indicator flashes red ON OFF c Verify that the pump interface illuminated green light ring flashes green ON OFF d Verify that the power display flashes 88 ON OFF Verify console defaults to power setting 01 when console is turned ON and after the visual sequence is complete Verify that no system fault is indicated with red LED Note A red LED indicates a system error that will prevent the console from operating If a system fault is indicated the console must be returned to Front panel layout On BB O Footswitch socket VERSAJET II Hydrosurgery System DL i Illuminated power switch turns the power ON and OFF interfaces with the footswitch Power display displays power setting Footswitch connection indicator LED System fault indicator LED Power controls allows the user to sequentially select power settings from 1 lowest through 10 highest 8 Pump interface an authorized service center for repair Verify the console power setting value changes when arrows are pressed there are a total of ten different power settings Note test both switches on the front panel and also the corresponding switches on the footswitch Verify that the pump interface illuminated green light ring is illuminated only when the
30. rom Customer Care at 1 800 876 1261 USA only or local Smith amp Nephew representative Turn console OFF by pressing power switch Ensure power cord is connected to an appropriate power source If necessary try a different electrical outlet 3 Wait at least 5 seconds after turning OFF Turn console ON by pressing power switch Ensure the yellow high pressure tube on handpiece is not kinked obstructed or tangled If error light is still illuminated replace handpiece Contact Customer Care 1 800 876 1261 USA only or local Smith amp Nephew representative to arrange a return Symptom Cause Handpiece does not prime No obstructed fluid supply Note Priming takes approximately 1 min at power level 10 Air in inflow line Obstruction of evacuation orifice debris tissue or other foreign material Excessive spray spattering Note Handpiece should not come into contact with bone tissue as it obstructs fluid flow and causes spraying Obstructed waste evacuation tube Fluid jet striking edge of metal evacuation oriface Remedy e Ensure saline bag is full and fluid flows freely e Check that pinch clamp is fully open e Check high pressure tube for kinks obstructions or leaks e Ensure saline bag is set at a level higher than the console e Reconnect or replace as necessary e While keeping handpiece at a safe distance set console power level to 10 and depress footswitch to purge all air in inflow t
31. st located on the rear panel see following diagram gt gt y smith amp nephew VERSAJET II 66800039 Hydrosurgery Console 100 240 V 50 60Hz pr 600W T6 3A 250V 2011 Kony A fe ce Made in USA for Fabriqu au Etats Unis pour Smith amp Nephew Inc 970 Lake Carillon Drive St Petersburg FL 33716 t rk of Marque de commerce de Smith amp Nephew www smith LA02854 D The pump interface is the correct location to establish a connection with the patient applied part a e EF VERSAJET Il Hydrosurgery system gt x smith amp nephew Attach test lead here 25 Product description VERSAJET II console model 66800039 Classification class type BF equipment Requirements IEC 60601 1 Table 2 Enclosure leakage Single fault lt 250 u Amp lt 500 u Amp Patient leakage lt 50 u Amp lt 100 u Amp Patient leakage Single fault lt 250 u Amp lt 500 u Amp Input VAC applied to Single fault lt 2500 u Amp lt 5000 u Amp patient applied part Notes e For earth leakage current single fault condition shall mean the interruption of either power supply conductor one at a time e For enclosure leakage current or patient leakage current single fault condition shall mean the interruption of either power supply conductor or the protective earth conductor one at a time e For patient leakage current single fault condition shall also mean application of rated mains
32. system indicator s are operating properly 10a Verify that the footswitch connection LED indicator flashes amber ON OFF 10b Verify that the system fault LED indicator flashes red ON OFF 10c Verify that the pump interface illuminated green light ring flashes green ON OFF 10d Verify that the power display flashes 88 ON OFF 11 Verify console defaults to power setting 01 when unit is turned ON 12 Verify system fault indicator red LED does not illuminate Verify the console power display value changes when arrows are depressed there are 10 settings 14 Verify that the pump interface illuminated green light ring functions properly 15 Verify that the footswitch connection LED indicator functions properly Console speed check Note console is plugged in and placed on bench for this step e A hand held optical tachometer is needed for this step 16 Power ON console by pressing illuminated power switch 17 Insert the speed stick into the pump interface and turn to the LOCKED position 18 Set console to its lowest power setting 01 19 Depress footswitch pedal allowing motor and transmission to cycle 20 Measure speed per console speed check instructions verify the RPM is 425 50 21 Set console to its highest power setting 10 22 Depress footswitch pedal allowing motor and transmission to cycle 23 Measure speed per console speed chec
33. t Separation distance according to frequency of transmitter M Rat i tput a a 150 kHz to 80 MHz 150kHzto 80 MHz 80MHz to 800 MHz 800 MHz to 2 5 GHz power of transmitter W For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 19 Warranty Limited one year warranty Limited Warranty Smith amp Nephew warrants for a period of one year from the date of sale of the console that the console Product shall perform to specifications as stated in the product manual In the event of failure to perform to specifications Smith amp Nephew shall repair or replace the Product at its discretion at no charge to Customer in accordance with its repair policy as stated in the Product Terms and Conditions In order to keep this product warranty in effect Customer must promptly notify Smith amp Nephew of any defects in writing within thirty 30 days of discovery of such defects or within one 1 year of t
34. three primary components e Console with footswitch reusable equipment e Single use handpiece assembly e Power cord regionally configured Console The VERSAJET Il console is an electrically powered device that drives the VERSAJET II handpieces The console is provided with an attachable footswitch and power cord Front panel layout VERSAJET II Hydrosurgery System A fa 4 1 Illuminated power switch turns the power ON 7 Illuminated green light ring indicates positive and OFF handset engagement 2 Footswitch socket interfaces with the 8 Pump interface interfaces and secures the footswitch handpiece pump assembly to the console 3 Power display displays power setting 9 Key lock symbols directs user to the open 4 Footswitch connection indicator LED eke do e pump positions 5 System fault indicator LED 6 Power controls allows the user to sequentially select power settings from 1 lowest through 10 highest Power display and fault indicators 9 A 1 Power display displays power setting Fault indicators illuminate if a fault is present 01 lowest power setting 10 highest power setting Footswitch 2 Footswitch not connected indicator an amber LED will illuminate when the footswitch is not fully connected or is a defective footswitch System fault indicator a red LED will illuminate indicating a power fault or an out of tolerance pressur
35. tream of sterile saline by hard tissues Spraying or misting is more frequent at lower power settings due to less pressure Spraying or misting may be reduced by keeping the waste evacuation tube straight As with all surgical procedures the VERSAJET II operator and other clinical personnel should follow the universal precautions for infection control including the use of surgical gloves facemask that covers the mouth and nose protective eye goggles protective clothing and anti slip shoe covers For optimal results when debriding hard or leathery eschar resulting from burn injuries it is recommended to first debride the eschar using sharp debridement techniques followed by the use of VERSAJET II to complete debridement or excision of the wound It is recommended that prior to clinical use of VERSAJET Il all operators of the device should be trained in the proper use of VERSAJET Il Smith amp Nephew has developed a training program contact your local market representative for details concerning VERSAJET Il training Do not allow saline bag to empty this could allow air to enter the supply tube Air in the supply tube will temporarily lower device efficiency and may require re priming of the system Select an appropriate sized waste container for the proceedure Connecting the waste evacuation tubing hose or any container connected to it to a vacuum source is not recommended and may increase the aggressiveness of
36. ube e Note To expedite the pinch clamp can be used to pull fluid through the inflow tube e Caution Ensure power level is set to 1 after priming is complete Ensure continuous flow of saline DO NOT allow saline bag to empty completely before changing 1 Turn console OFF by pressing power switch 2 Remove obstruction 3 Turn console ON by pressing power switch 4 Restore to desired power level Ensure that e The distal end of the evacuation tube is connected to a non filtered port of a waste collection container e Collection container is vented e Evacuation tube is not obstructed kinked or pinched e Collection container is at lowest possible point below console level e Collection container is not full e Saline supply is above console provides gravity feed pressure Replace handpiece Return initial handpiece by contacting Customer Care at 1 800 876 1261 USA only or local Smith amp Nephew representative Glossary of symbols Equipment Single use classification 2 do not reuse Isolation type BF applied part dt CSA international classification Keep dry Q ya G 55 C Storage temperature EU not for general waste 10 o Caution see instructions for use also indicates FAULT on the front panel Date of manufacture amp 1x E fa a le REP European representative Lot number Serial number Product catalog number This produci and Plac
37. with forceps Once the obstruction is removed depress the footswitch and check for steady stream of sterile saline flow If the obstruction is not completely removed repeat procedure or check that the waste evacuation tube is not pinched by forceps stepped on or that the collection container is full 16 After completing the procedure turn OFF the console by pressing the power switch located on the front of the console Disconnect the handpiece from the pump interface by turning the orange pump assembly counterclockwise to the 12 o clock position Remove the pump cartridge by pulling it straight out Discard handpiece in accordance with your healthcare facility s standard guidelines for biohazardous waste disposal Console maintenance and cleaning Maintenance The fan slots and other vents on the bottom of the console should be kept free from obstructions and periodically inspected for excessive build up of dust and or foreign material The pump interface should be inspected periodically for build up of deposits and or debris A damp cloth with mild detergent can be used to remove material Do not soak the inside Excessive fluid can cause damage If the power cord or footswitch are damaged these should be replaced Please refer to Appendix B Ordering Information section Further information on user performance and safety testing can be found in Appendix C VERSAJET II Console Performance and Safety Check This is
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