VERSAJET II Hydrosurgery system user manual
Contents
1. 1 2 Connection to mains grounding is accomplished through use of the grounding post located on the back of the console see following diagram 5 1 3 The steel plate behind the knob on the top of the user interface is the proper location to establish a connection with the patient applied part see following diagram Attach test lead here User interface Patient applied part Ground plug Product description model 50700 and 50750 VERSAJET console Classification class type BF equipment Requirements IEC 60601 1 Test Equipment Limit at 120 V Limit at 240V Condition 50700 50750 Ground integrity Normal 0 2 Ohms 0 2 Ohms Earth leakage Normal lt 250 u Amp lt 500 u Amp Earth leakage Single fault lt 500 u Amp lt 1000 u Amp Enclosure leakage Normal lt 50 u Amp lt 100 u Amp Enclosure leakage Single fault lt 250 u Amp lt 500 u Amp Patient leakage Normal lt 50 u Amp lt 100 u Amp Patient leakage Single fault lt 250 u Amp lt 500 u Amp Input VAC applied Single fault lt 2500 u Amp lt 5000 u Amp to patient applied part Notes For earth leakage current single fault condition shall mean the interruption of either power supply conductor one at a time 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 For pati2. S Smith amp Nephew BV Kruisweg 6592132 NG Hoofddorp Tel 0031 020 6543999 NEW ZEALAND Smith amp Nephew Ltd PO Box 442 621 Rosebank Road Avondale Auckland Tel 64 9 828 4059 NORWAY Smith amp Nephew A S PO Box 224 Nye VakasVei 64 1379 Nesbru Tel 66842020 PAKISTAN Smith amp Nephew Pakistan Private Ltd A 69 SITE Manghopir Road SITE PO Box 3659 Karachi 75700 Tel 21 2561176 PORTUGAL Smith amp Nephew LdaGalerias Alto da BarraAv das Descobertas N59 Piso 3Alto da Barra 2780 053 OEIRAS Tel 21 446 06 50 SINGAPORE Smith amp Nephew Pte Ltd1 Jalan Kilang Timor 08 03 05 Pacific Tech Centre 159303 Tel 65 6 270 0552 SOUTH AFRICA Smith amp Nephew Ltd PO Box 92 Pinetown Natal 3600 Tel 031 7108111 SPAIN Smith amp Nephew SA Fructuos Gelabert 2y4 08970 Sant Juan Despi Barcelona Tel 373 7301 www smith nephew com wound www versajet info SWITZERLAND Smith amp Nephew AGGiutz Biotzheim Str 1GH 4502 Solothurn Tel 32 624 5660 TAIWAN Smith amp Nephew Ltd 8F 4 79 Hsin Tai 5th Road Sec 1 Hsichi Taipei County Tel 886 2 2698 9711 THAILAND Smith amp Nephew Ltd 344 3 Soi Rongrien Yepun Rama IX Road Kwang Bangapi Khet Huay Kwang Bangkok 10320 Tel 66 2 719 622127 UNITED STATES Smith amp Nephew Inc Wound Management Division 11775 Starkey Road PO Box 1970 Largo FL33779 1970 Tel 1 727 392 1261 TURKEY Interfarma KS Mithatpasa C No 24 7 Yenis
3. VERSAJET console performance and safety check N smith amp nephew VERSAJET Hydrosurgery System DI FrAACO r UIUS The purpose of this procedure is to provide a performance and safety check for the VERSAJET power console model 50700 120V and model 50750 240V Important note The VERSAJET 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 al aTa ie CC j DCU ad nd This procedure is applicable to all VERSAJET consoles as a reference guide to help customers wishing to perform performance checks by themselves Refer to the Versajet Hydrosurgery system manual for additional information on the correct use of the console and its specifications Optical Tachometer Ametek 1726 or equivalent hospital is responsible for purchase Electrical testing equipment hospital responsible for purchase RPM verification tool speed stick Smith amp Nephew contact your local sales representative rerrorl ance CNecK porocequre A checklist is provided at the end of this document to record the results of the following checks 4 1 Physical appearance check 4 11 Make sure console is unplugged from electrical power 4 1 2 Check consol
4. amp Nephew Pty Ltd 315 Ferntree Gully Road Mount Waverley Victoria 3149 Tel 03 8540 1360 AUSTRIA Smith amp Nephew GmbH Concorde Business Park D2 Top 11 2320 Schwechat Tel 17079102 BELGIUM Smith amp Nephew SA NVAv du Four a Briques 3b1140 Bruxelle Kareelovenlaan 3b 1140 Brussels Tel 02 7022911 CANADA Smith amp Nephew Inc 4707 Levy Street St Laurant QC H4R 2P9 Tel 1 514 956 1010 CHINA Smith amp Nephew Ltd 19F Harbour Ring Hiang Pu CentreNo 98 Liu He Road Shanghai 200041 Tel 86 21 63503100 DENMARK Smith amp Nephew A SNaerum Hovedgade 22850 Naerum Tel 45 45 80 61 00 EASTERN EUROPE Smith amp Nephew Service GmbH Max Planck Strasse 1 3 D 34253Lohfelden Tel 49 561 9514 0 FRANCE Smith amp Nephew SAS Espace Novaxis25 Boulevard Alexandre Oyon 72019 Le Mans Cedex 2 Tel 33 0 2 43 83 23 23 FINLAND Smith amp Nephew OyAyritie 12 C01510 Vantaa Tel 0 10 218 7300 GERMANY Smith amp Nephew GmbH Medical Division Max Planck Sir 1 3D 34253 Lohfelden Tel 561 95140 GREECE Costas A Papaelinas Hellas SA26th km Paeanias Makopoulou AvePO Box 182 19400 Koropi Tel 662 6201 7 HONG KONG Smith amp Nephew Ltd Unit 813 816 8 F Delta House 3 On Yiu Street Shatin N T Tel 852 2648 7700 INDIA Smith amp Nephew Healthcare Ltd323 B Chintamani Plaza Andheri Kurla Road Andheri East Mumbai 400 099 Tel 91 22 4005 5090 INDONESIA PT Sm
5. ce as per electrical testing instructions Take readings as per electrical teseting instructions to check if leakage is occuring Disconnect test leads and turn main power switch to off position Unplug power cord from outlet and from back of console Summary of results Overall Physical Appearance showed no anomalies and unit is clean Basic Functional Setup indicates functions evaluated are operational Console Speed verification meets spec as defined in Hospital Test Protocol Electrical Equipment Safety Testing indicates readings meet requirements Please photocopy this page when performing the checklist so that you will always have a blank copy Yes No Yes No Yes No Yes No Yes No If any of the Summary Results are NO this could be an indication of a need for Service or Repair Please contact your Smith amp Nephew Customer Care Representative immediately and have this report available at time of call Comments Comments Comments Comments Comments UK Smith amp NephewHealthcare Ltd Healthcare House Goulton Street Hull HU3 4DJ Tel 01482 222200 AUSTRALIA Smith
6. e for visible dents cracks or missing pieces 4 1 3 Check that fan slots are free from obstructions dust or foreign materials 4 1 4 Inspect console ventilation slots located on rear and back of the instrument Remove obstructions dust or foreign materials using vacuum and or household all purpose cleaner and wipes 4 1 5 Check that the black console lever on the UI User Interface rotates freely between 4 and 6 o clock position 4 1 6 Check that on off rocker switch moves to each position and remains in place 4 1 7 Check foot switch and attached cord for signs of loose or missing insulation 4 1 8 Check foot switch mechanical operation for engage and disengage by depressing and releasing 4 1 9 Inspect power cord for any frayed or missing insulation and bent loose or missing plug blades or earth ground 4 2 4 2 1 4 2 2 4 2 3 4 2 4 4 2 5 4 2 6 Error lamp indicators Main power switch System diagnostics check Make sure console is plugged into an electrical outlet Turn the main power switch to the on position and verify that the switch is illuminated and green in color verify the lamp extinguishes with the switch in the off position Verify console defaults to power level 1 when unit is turned on using front power switch Verify the unit power level value changes when arrows are depressed there are a total of ten different power settings Verify that the door error lamp
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8. ent leakage current single fault condition shall also mean application of rated mains voltage to the patient applied part relative to the protective earth conductor Important note The VERSAJET 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 Steps on oOo oO FP OO DY 10 1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Physical Appearance Check Caution unit is unplugged and placed on bench for this step Check Console for visible Dents Cracks Missing pieces Check that ventilation slots are free from Obstructions Dust or Foreign Materials Check that labels and markings are intact and ledgible with no smudges Check that Console Knob on UI User Interface rotates freely between 4 and 6 o clock position Check that On Off Rocker switch moves to each position and remains in place Check Foot Switch and attached cord for signs of turn or missing insulation Check Foot Switch Mechanical Operation for Engage and Disengage by depressing and releasing Inspect Power Cord for any frayed or missing insulation and bent loose or missing plug blades or earth ground System Diagnostics Check Note u
9. is Illuminated when the lever is open 4 o clock Off when user interface knob is in the closed position 6 o clock Verify the pedal error lamp is Illuminated when the footswitch connector is not plugged into the front of the console e Off when footswitch connector is inserted Note lamp on signals a system error that will prevent the console from operating Console control display panel Power level switches Footswitch connection 4 3 4 3 1 4 3 2 4 3 3 Step 3 4 3 4 4 3 5 4 3 6 4 3 7 4 3 8 4 3 9 Console speed check Turn the knob on the user interface to the open position Insert the speed stick until fully seated into the opening in the user interface step 1 Turn the user interface knob to the closed position step 2 POWER LEVEI Step 4 Set the console to lowest setting of 1 Step 3 Depress and hold the footswitch down to allow the console to cycle its motor transmission Aim the tachometer optical beam so that the reflector on the speed stick produces a RPM reading Step 4 Measure speed Spec 390 50 RPM Set console to highest setting of 10 and repeat the measuring steps Measure speed spec 1210 100 RPM 5 0 Safety check procedure 5 1 Electrical testing check also see product manual 5 1 1 Ensure the console and test equipment are set to the same input voltage setting prior to conducting electrical testing 5
10. ith amp Nephew Healthcare PT Enseval Putera Megatrading TbkJI Pulo Lentut No 10Kawasan Industri Pulo GadungJakarta 13920 Indonesia Tel 62 21 4682 2422 IRELAND Smith amp Nephew Ltd Carraig Court George s Avenue Blackrock Co Dublin Tel 01 217 0444 Made in USA for Fabriqu on USA pour Smith amp Nephew Inc 11775 Starkey Road Largo FL 33773 USA 727 932 1261 EU Authorised Representative Repr sentatif Autoris Smith amp Nephew Medical Ltd 101 Hessle Road Hull HU3 2BN UK Trademark of Smith amp Nephew 6089 2 Global Performance Safety Manual ITALY Smith amp Nephew S r l Via De Capitani 2A 20041 Agrate Brianza Milano Tel 39 039 60941 JAPAN Smith amp Nephew Wound Management KK Shiba Nikkei Yuaku Bld1 10 13 Shiba Minato ku Tokyo 105 0014 Tel 81 3 5443 5721 KOREA Smith amp Nephew Ltd ASEM Tower 13F 159 1 Samsung dong Gangnam gu Seoul Korea 135 7 98 Tel 82 2 6001 7575 MALAYSIA Smith amp Nephew Healthcare Sdn BhdMenara Merais No 1 Jalan 19 346300 Petaling Jaya Selangor Darul Ehsan Malaysia Tel 60 3 7958 7103 MALTA VJ Salamone Ltd PO Box 55 Valletta Malta MEXICO Smith amp Nephew SA de CV San Francisco Cuautalpan No 101 Fracc Alce Blanco Naucalpan De Juarez Estado de Mexico CP 53370 Tel 5359 5252 MIDDLE EAST Smith amp Nephew Fze PO Box 9359 Dubai World Trade Centre Level 19 Dubai United Arab Emerates Tel 4 331 7000 NETHERLAND
11. nit is plugged in and placed on bench for this step Adjust main power switch to ON and OFF positions Verify console defaults to power level 1 when unit is turned on main front power switch Verify the unit power level value changes when arrows are depressed there are 10 settings Verify that the Door error lamp is on when door is at 4 o clock posiion Verify that the Door error lamp is off when door is at 6 o clock posiion Verify the Pedal error lamp is on when the foot switch is not plugged in Verify the Pedal error lamp is off when the foot switch is plugged in Console Speed Check Note unit is plugged in and placed on bench for this step A hand held tachometer is needed for this step Turn main power switch switch to On Position Turn knob on User Interface to Open position Insert the Speed Stick in the User Interface until fully seated Set Console to its Lowest setting 1 Depress Footpedal allowing motor and transmission to cycle Measure Speed per Console Speed Check Instructions Set Console to its Highest setting 10 Depress Footpedal allowing motor and transmission to cycle Measure Speed per Console Speed Check Instructions Electrical Equipment Safety Check Note unit is plugged in and placed on bench for this step A meter capable of measuirng micro amps is required Turn main power switch to On Position Attach test leads to Ground Plug and UI User Interfa
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