Table of Contents
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BRAND
SKU
COMPONENT User Manual
PRODUCT
THIS BSC/REF 30958
PREV BSC/REF
DIMENSIONS
COLOURS
Match to
coated stock
PMS
DATE
JOB NUMBER S38163 - 6389
ARTWORK
VERSAJET™ III
N/A
Hydrosurgery System
N/A
A5 (24pp)
Black
Pantone 1375 C (Cover only)
CMY (Pages 6, 14 & 16 only)
12.04.2022 REVISION
CHECKED
MP
17
ARN
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Summary of Contents for smith&nephew VERSAJET III
- Page 1 BRAND VERSAJET™ III COMPONENT User Manual PRODUCT Hydrosurgery System THIS BSC/REF 30958 PREV BSC/REF DIMENSIONS A5 (24pp) COLOURS Black Match to Pantone 1375 C (Cover only) coated stock CMY (Pages 6, 14 & 16 only) DATE 12.04.2022 REVISION JOB NUMBER S38163 - 6389 ARTWORK CHECKED...
- Page 2 VERSAJET ◊ Hydrosurgery System User Manual...
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Page 4: Table Of Contents
11. Glossary of symbols 12. Technical information 13. System specifications 14. Environmental Conditions 15. Electromagnetic compatibility VERSAJET III Hydrosurgery System (REF 66802146) 16. Guidance and manufacturer’s declaration – electromagnetic emissions VERSAJET III Hydrosurgery System (REF 66802146) 17. Warranty 18. Appendix A Company position regarding the reprocessing and reuse of single-use only medical devices 19. -
Page 5: Description
• Examine all components before use. DO NOT 2. Indications for Use use, if you believe a component to be faulty or damaged. Contact your local Smith+Nephew The VERSAJET III Hydrosurgery System ◊ VERSAJET III System representative. -
Page 6: System Components
6. System components The VERSAJET III System consists of four primary components: ◊ Reusable Equipment: • Console • Foot pedal • Power cord Single-Use Equipment: • Single-use hand piece and associated tubing 6.1. Console • The VERSAJET III Console is an electrically powered device that controls the pumping of ◊... -
Page 7: Rear Panel Layout
6.1.3. Rear panel layout VERSAJET 66802146 ◊ Hydrosurgery System Console 100-240V~ 50/60Hz 600W YYYY-MM-DD T 6.3A H x2 250V IPX3 FCC ID: 2AWH9-VJIII Smith & Nephew Medical Limited, 101 Hessle Road, Hull HU3 2BN, England © 2022 Smith+Nephew. ◊ Trademark of Smith+Nephew Certain marks Reg. -
Page 8: Single-Use Hand Piece
6.3. Single-Use Hand Piece The sterile VERSAJET III Hand Piece and associated tubing should be disposed of after use as ◊ clinical waste. The hand piece 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 vacuum effect, following the principles of the Venturi effect. -
Page 9: Hand Piece Options
6.3.1. Hand Piece Options There are two single-use VERSAJET III hand piece types – PRECISION and PROCLINICAL. ◊ VERSAJET III PRECISION Hydrosurgery System Hand Piece ◊ Order no. Description 66802147 VERSAJET III PRECISION ◊ Hand Piece (15º/14mm) 15° For operating room only 14mm 66802148 VERSAJET... -
Page 10: Instructions For Use
7. Instructions for Use 7.3. Power cord socket CAUTION: Before connecting the device to an It is recommended that prior to clinical use of electrical outlet, ensure that you have selected VERSAJET III System, all operators of the device ◊ the appropriate power cord for the local power should be trained in the proper use of VERSAJET ◊... -
Page 11: Connect The Saline Bag(S)
4. Remove the hand piece from the clam Ensure there is an additional open port shell and place in the sterile field or onto a on the waste canister lid, to prevent a sterile surface. DO NOT remove the orange pressure build-up inside the canister. -
Page 12: Removal Of An Obstruction In The Evacuation Orifice
burn injuries, it is recommended to 2. Release the foot pedal and remove the first debride the eschar using sharp obstruction with forceps. debridement techniques followed by the NOTE: Avoid touching the opening in the use of VERSAJET III System to complete ◊... -
Page 13: Hand Piece Quick Set-Up Pictorial Guide
7.12. Hand piece quick set-up pictorial guide... -
Page 14: Console Cleaning And Maintenance
8. Console cleaning 8.2. Maintenance and maintenance Smith+Nephew recommends that dielectric strength, earth leakage current and 8.1. Cleaning protective earth testing be performed Follow your healthcare facility’s standard annually to assure continued compliance procedures for decontaminating surgical with applicable safety requirements. equipment to decontaminate the console, These tests should be conducted in foot pedal and power cord. -
Page 15: Troubleshooting Guide
10. Troubleshooting Guide Follow the below troubleshooting steps. If the fault is not resolved, contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative. Fault Potential Cause Solution No / intermittent Console power switch not • Press power switch; power switch should become electrical power illuminated illuminated... - Page 16 Follow the below troubleshooting steps. If the fault is not resolved, contact Customer Care at 1-800-876-1261 (USA Only) or your local Smith+Nephew Representative. Fault Potential Cause Solution Hand piece does not No / obstructed fluid 1. Ensure saline bag is full and fluid flows freely Prime supply 2.
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Page 17: Glossary Of Symbols
11. Glossary of symbols Follow instructions Do not re-use Lot number for use Consult instructions Date of manufacture Serial number for use Sterilized using Product catalog Manufacturer ethylene oxide number Do not use if Keep Away Keep dry package is damaged From Sunlight Temperature limitation Humidity limitation... -
Page 18: System Specifications
13. System specifications Product dimensions and weights Front panel Console Size 40cm W x 35cm D x 18cm H 15.8in W x 13.8in D x 7.1in H Power switch, ON/OFF (I/O) Weight 13.6kg / 30lbs IP classification IPX3 Foot pedal connection Footswitch Size 19cm W x 18.4cm D x 5cm H... - Page 19 15. Electromagnetic compatibility VERSAJET III System ◊ (REF 66802146) This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2014 4th edition as a Class B digital device, pursuant to part 15 of the FCC Rules.
- Page 20 Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidelines Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or ceramic tile. If discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV, floors are synthetic, the relative humidity should IEC 61000-4-2 ±15 kV air...
- Page 21 16. Guidance and manufacturer’s declaration – electromagnetic emissions VERSAJET III System (REF 66802146) ◊ 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 –...
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Page 22: Warranty
17. Warranty Limited one-year warranty S&N products are warranted to conform in all material respects to S&N’s standard specification for a particular product in effect at the time of product delivery to the buyer (including any tolerance parameters) for the warranty period specified for the products at www.SNWarranties.com. -
Page 23: Appendix B Ordering Information
18. Appendix A Company position regarding the reprocessing and reuse of single-use only medical devices As a manufacturer of single-use medical devices, including 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. - Page 25 Smith & Nephew Medical Limited, 101 Hessle Road, Hull HU3 2BN England Customer Care Center 1 800-876-1261 www.smith-nephew.com www.educationunlimited.smith-nephew.com 2022 Smith+Nephew © Trademark of Smith+Nephew ◊ Certain marks Reg. US Pat. & TM Off. This product may be covered by one or more US Patents. See: www.smith-nephew.com/patents 04/2022 30958...
- Page 26 BRAND VERSAJET™ III COMPONENT User Manual Review PRODUCT Hydrosurgery System THIS BSC/REF 31230 BASED ON 27441 DIMENSIONS 215.9 x 279.4 (2pp) COLOURS Black Match to Pantone 1375 C (One side only) coated stock DATE 03.03.2022 REVISION JOB NUMBER S38181 - 6433 ARTWORK CHECKED...
- Page 27 System Installation VERSAJET III PRECISION/ ◊ VERSAJET III PROCLINICAL ◊ Hydrosurgery System Hand Piece...
- Page 28 VERSAJET III PRECISION/ ◊ 2. Connect Saline Bag(s) 7. Changing the Saline Bag(s) It is recommended that full saline bag(s) are connected prior to 1. When using one saline bag: If additional saline is required, attach an VERSAJET III PROCLINICAL ◊...
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