VERSAJET II User Guide Sept 2012

EN

*smith&nephew VERSAJET™ II

User guide

Hydrosurgery System

Table of contents

page number

Indications

4

Troubleshooting guide

14

Safety

4

Warnings

4

Glossary of symbols

16

Precautions

4

Technical information

16

System components

6

System specifications

17

Console

6

Console front panel

17

Front panel layout

6

Console rear panel

17

Footswitch

7

Product dimensions and weights

17

Back panel layout

8

Handpiece components

8

Single-use handpiece environmental conditions

17

Single-use handpiece asssebly

8

Console environmental conditions

17

Handpiece options

9

Electromagnetic compatibility

18

System set-up

10

Console set-up

10

Warranty

20

Connecting the footswitch

10

Appendix A

20

Power cord socket

10

Turning the console ON

10

Handpiece quick set-up pictorial guide

11

Company position regarding the reprocessing and reuse of single-use only medical devices

Single-use handpiece set-up and system priming

12

Console maintenance and cleaning

13

Maintenance

13

Cleaning

13

Disposal of the console and accessories

13

Appendix B

21

Ordering information

Appendix C

22

Console performance and safety check

Global Customer Service

3

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Indications

any sharp instrument, care and attention must be maintained while using the VERSAJET II Plus handpieces near delicate vessels and structures.

The VERSAJET II 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 judgment, require sharp debridement and pulsed lavage irrigation.

• VERSAJET II is intended primarily for use in the operating room environment. Only the 45 degree VERSAJET II 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.

Safety The VERSAJET II 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.

• The 15 degree, 14mm VERSAJET II 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 II 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.

Warnings • This device should be used with particular care in patients with hemophilia or other blood clotting disorders and in patients receiving anti-coagulant medication.

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.

• 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.

• In order to avoid unwanted procedural delays, assure the system is fully operational prior to administration of anesthesia.

• Increasing console power settings will lead to more aggressive tissue removal. Use caution near delicate vessels and structures, such as neurovascular bundles.

• 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 stream of sterile saline by hard tissues.

• The VERSAJET II handpieces are designed for connection only to the VERSAJET II system console. DO NOT attempt to connect to any other equipment.

• 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.

• The VERSAJET II Plus handpieces provide more aggressive debridement and excision when compared to the VERSAJET II 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

• 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). 4

EN • 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.

• 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 II 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 www.versajet.info

• It is recommended that prior to clinical use of VERSAJET II, all operators of the device should be trained in the proper use of VERSAJET II. Smith & Nephew has developed a training program; contact your local market representative for details concerning VERSAJET II 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 procedure. • 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 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 & Nephew VERSAJET II representative. • Pre-heating saline prior to use with VERSAJET II 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.

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System components The VERSAJET II system consists of three primary components: • Console with footswitch (reusable equipment) • Single-use handpiece assembly • Power cord – regionally configured

Console The VERSAJET II 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

3

7

1 6 2

9 8 10

4

5

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 (UNLOCKED) and the closed (LOCKED) handpiece pump positions

4. Footswitch connection indicator (LED) 5. System fault indicator (LED)

10. Type BF Applied Part – the handpiece has a type

6. Power controls – allows the user to sequentially

BF rating

select power settings from 1 (lowest) through 10 (highest)

6

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Power display and fault indicators

1

2

3

1. Power display – displays power setting

Fault indicators – illuminate if a fault is present

2. Footswitch not connected indicator – an amber LED will illuminate when the footswitch is not fully connected or is a defective footswitch

01 = lowest power setting

3. System fault indicator – a red LED will illuminate indicating a power fault or an out of tolerance pressure condition • If a fault occurs, the console should be sent back to the manufacturer for service. DO NOT attempt to open the unit to perform repair.

10= highest power setting

Footswitch 1. Footswitch pedal – depressing the footswitch pedal activates the cutting jet

2. UP toe button – depressing the toe button next to

5

the UP arrow increases the power setting

3

3. DOWN toe button – depressing the toe button

2

next to the DOWN arrow decreases the power setting

4. Footswitch connector – connects the footswitch to the footswitch socket on the console

4

5. Footswitch cable – connects the footswitch connector to the footswitch

1

7

EN

Rear panel layout

1

KVAE120001 2012

3

2

1. Input power cord socket – interfaces with the detachable power cord through a three prong socket • 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

Handpiece components

WARNING: The VERSAJET II handpiece is designed for connection only to the VERSAJET II Hydrosurgery System Console (66800039). Do NOT attempt to connect to any other equipment.

Single-use handpiece assembly The VERSAJET II single-use handpiece assembly is a 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 nonviable tissue and contaminants.

8

EN

1

2 5 3

4

6

7

1. 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 orifice

2. Handpiece – an ergonomic handle supporting the instrument tip; receives the high-pressure line and waste evacuation line at the proximal end (white)

3. Inflow tube – a clear tube with white spike and pinch clamp that connects to a saline bag 4. Pump cartridge – couples with the pump interface on the console (orange) 5. High pressure tube – a tube that carries pressurized saline to the distal tip of the handpiece 6. 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

7. Clam shell – a clear plastic enclosure that holds the handpiece and pump cartridge Handpiece options The VERSAJET II handpiece is available in two styles – Exact and Plus. VERSAJET II Exact handpieces Order no.

Description

66800040

VERSAJET II Exact disposable handpiece (15º/14mm)

14mm 15°

66800041

VERSAJET II Exact disposable handpiece (45º/14mm)

66800042

VERSAJET II Exact disposable handpiece (45º/8mm)

14mm 45°

8mm 45°

VERSAJET II Plus handpieces Order no.

Description

66800043

VERSAJET II Plus disposable handpiece (15º/14mm)

66800044

VERSAJET II Plus disposable handpiece (45º/14mm)

66800045

VERSAJET II Plus disposable handpiece (45º/8mm)

14mm 15°

14mm 45°

8mm

45°

Lower deck height

Higher deck height

Narrower channel

Wider channel 9

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System set-up This section provides the procedures for set up and operation of the VERSAJET II 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 the threeprong 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.

10

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Handpiece quick set-up pictorial guide

11

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Single-use handpiece set-up and system priming

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

1. Remove the pouch from carton. Inspect pouch to

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 footswitch for convenient access.

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.

10. Insert the female three-prong plug of the power

2. Inspect inner pouch to ensure seals are intact and

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.

pouch is not damaged. Open inner pouch, remove the sterile contents and place securely in the sterile field. Avoid tangling and knotting of hoses.

11. Remove the protective cover from the tip of

3. Remove white handpiece from clam shell and

handpiece.

place in sterile field. Do not remove pump cartridge (orange handle) from clam shell tray.

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 orifice, indicates the system is primed. Priming takes approximately 30 seconds. Release the footswitch and reduce the power setting to 1 before use.

4. 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 tube, orange pump cartridge in clam shell tray and waste evacuation line to the circulator nurse for final system set up.

13. CAUTION: Once the system has been primed with

5. The circulator nurse should remove the orange

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.

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.

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.

6. 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.

15. If the evactuation orifice 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 highpressure jet 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

7. 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.

8. 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. 12

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Cleaning

procedure or check that the waste evacuation tube is not pinched by forceps, stepped on or that the collection container is full.

Follow your healthcare facility’s standard procedures for decontaminating surgical equipment to decontaminate the console, footswitch and power cord.

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.

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.

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.

This procedure should be performed after each console use.

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.

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 1-800-876-1261 (USA only) or local Smith & Nephew representative to return a console for repair or replacement.

If the power cord or footswitch are damaged, these should be replaced. Please refer to Appendix B, Ordering Information section.

Recommended annual performance checks Smith & Nephew recommends that dielectric strength, earth leakage current and protective earth testing be performed annually to assure continued compliance with applicabable safety requirements. These tests shoul be conducted in accordance with specifications UL 60601-1/IEC 60601-1. CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified person. Further information on user performance and safety testing can be found in Appendix C ‘VERSAJET II Console Performance and Safety Check’. This is also available for download at www.versajet.info 13

EN

Troubleshooting guide Symptom

Cause

Remedy

No/intermittent electrical power

Power cord not connected or connected loosely at console or electrical outlet

Ensure that power cord is: • Fully seated into the back of the console and electrical outlet

Note: The console will default to power level 1 if power is interrupted

Footswitch LED

• Not damaged and free of defects • For replacement power cord contact Customer Care at 1-800-876-1261 (USA only) or local Smith & Nephew representative

Power not present at electrical outlet

• Ensure that the electrical outlet has power

Console power switch not illuminated

• Press power switch; power switch should become illuminated

Footswitch not connected properly

• Observe red alignment dots on footswitch connector and footswitch socket are properly aligned

• Connect to a different electrical outlet

• Ensure the footswitch connector is fully inserted Console not responding to footswitch and footswitch connector indicator is NOT illuminated

Footswitch obstructed

• Ensure that there are no objects obstructing the footswitch from being depressed or releasing

Footswitch inoperative

• Order replacement footswitch (66800472) from Customer Care at 1-800-876-1261 (USA only) or local Smith & Nephew representative

System fault LED illuminated

Power fault caused by over-current

1. Turn console OFF by pressing power switch 2. 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 4. Turn console ON by pressing power switch System over-pressure condition out of tolerance

• 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 & Nephew representative to arrange a return

14

EN Symptom

Cause

Remedy

Handpiece does not prime

No/obstructed fluid supply

• Ensure saline bag is full and fluid flows freely • Check that pinch clamp is fully open

Note: Priming takes approximately 1 min at power level 10

• Check high pressure tube for kinks, obstructions or leaks • Ensure saline bag is set at a level higher than the console • Reconnect or replace as necessary Air in inflow line

• While keeping handpiece at a safe distance set console power level to 10 and depress footswitch to purge all air in inflow tube • Note: To expedite, the pinch clamp can be used to pull fluid through the inflow tube • 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

Excessive spray/ spattering Note: Handpiece should not come into contact with bone tissue as it obstructs fluid flow and causes spraying

1. Turn console OFF by pressing power switch

Obstruction of evacuation orifice (debris, tissue or other foreign material)

2. Remove obstruction 3. Turn console ON by pressing power switch 4. Restore to desired power level

Obstructed waste evacuation tube

Ensure that: • The distal end of the evacuation tube is connected to a non-filtered port of a waste collection container • Collection container is vented • Evacuation tube is not obstructed, kinked or pinched • Collection container is at lowest possible point below console level • Collection container is not full • Saline supply is above console (provides gravity feed/pressure)

Fluid jet striking edge of metal evacuation orifice

Replace handpiece. Return initial handpiece by contacting Customer Care at 1-800-876-1261 (USA only) or local Smith & Nephew representative

15

EN

Glossary of symbols Follow instructions for use

Single-use do not reuse

European representative

Keep dry

Lot number

CSA international classification

Storage temperature

Serial number

EU: not for general waste

Date of manufacture

Product catalog number

Caution: indicates FAULT on the front panel

Place of manufacture

This product and packaging do not contain natural rubber latex

Protect from direct sunlight

Fuse

Do not use if package is damaged

Green point (UK)

Footswitch connection

Equipotentiality (protective grounding)

CE mark

RoHS compliant

Equipment classification Isolation type BF applied part

LATEX

STERIL E EO

Method of sterilization

Federal (USA) law

only restricts this device to

sale by or on the order of a physician.

Technical information

Contact Customer Care at 1-800-876-1261 (USA only) or local Smith & Nephew representative to return console for repair or replacement.

CAUTION: Only VERSAJET II system equipment should be connected to the console. There are no user serviceable parts within the console. All required service must be performed by the manufacturer. 16

EN

System specifications

Product dimensions and weights Console

Console Size

Front panel

15in W x 11.8in D x 5.8in H 38.1cm W x 30cm D x 14.8cm H

Power switch, ON/OFF (I /0) Footswitch connection

Weight

Power setting (levels 1 – 10)

IP classification IPX1

26lbs/11.8kg Footswitch

Pump interface – type BF Applied Part

Size

7.5in W x 7.25in D x 2in H

Lock position (for pump cartridge)

19cm W x 18.4cm D x 5cm H

Unlock position (for pump cartridge)

Weight

3lbs/1.1kg

Cord length

15ft/4.6m

Amber footswitch indicator light

IP classification IPX8

Red fault indicator light

Power cord

Rear panel

Length

Prior to connecting the device to an electrical 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

Power cord

Detachable hospital grade power cord with C13 plug

Power input rating

100-240 VAC 600 W 50/60 Hz

Fuse ratings

Dual slo-blo type T6.3A/250 VAC 5 x 20 mm fuses

Mode of operation

Continuous

Applied part classification

Type BF

Equipment classification

Class I

Compliance

IEC 60601-1 : 2005 UL 60601-1 CAN/CSA C22.2 No.601.1

Listing

15ft/4.6m

Single-use handpiece environmental conditions Unless otherwise stated, the following conditions apply for product use as well as shipping and handling Temperature range Shipping and handling

-40°F (-40°C) to 125°F (52°C)

Product use

50°F (10°C) to 90°F (32°C)

Humidity range

10% to 90%, non-condensing

Atmospheric pressure

700 to 1060 hPa

Console environmental conditions Unless otherwise stated, the following conditions apply for product use as well as shipping and handling. Temperature range

CSA International

17

Shipping and handling

-4°F (-20°C) to 131°F (55°C)

Product use

50°F (10°C) to 90°F (32°C)

Humidity range

10% to 90%, non-condensing

Atmospheric pressure

700 to 1060 hPa

EN

Electromagnetic compatibility This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2006. 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 no guarantee that interference will not occur in a particular installation. Guidance and Manufacturer’s declaration – electromagnetic immunity. The VERSAJET II Hydrosurgery System (66800039) is intended for use in the electromagnetic environment specified below. The customer or the user of the VERSAJET II Hydrosurgery System should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 test level

Compliance level

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Electrical fast transient/ burst IEC 61000-4-4

±2 kV for power supply lines

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV for input/output lines

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

±1 kV line to line ±2 kV line to earth

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

>95% for 10ms 60% for 100ms 30% for 500ms >95% for 5000ms

Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 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 VERSAJET II Hydrosurgery System requires continued operation during power mains interruptions, it is recommended that the VERSAJET II Hydrosurgery System be powered from an uninterruptible power supply or battery.

NOTE UT is the AC mains voltage prior to application of the test level. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

0,3 A/m

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

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 the VERSAJET II Hydrosurgery System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P (80 MHz to 800 MHz) d = 2.3√P (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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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 II 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 II Hydrosurgery System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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EN Guidance and Manufacturer’s declaration – electromagnetic emissions. The VERSAJET II Hydrosurgery System (66800039) is intended for use in the electromagnetic environment specified below. The customer or the user of the VERSAJET II Hydrosurgery System should assure that it is used in such an environment. Compliance

Electromagnetic environment - guidelines

RF emissions CISPR 11

Emissions test

Group 1

RF emissions CISPR 11

Class B

The VERSAJET II Hydrosurgery System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.

Harmonic emissions IEC 61000-3-2

Class B

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

The VERSAJET II Hydrosurgery System is suitable for use in hospital establishments and those directly connected to the public low-voltage power supply network that supplies buildings 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 II 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 II 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 II Hydrosurgery System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The VERSAJET II Hydrosurgery System as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter M 150 kHz to 80 MHz

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 3.5√P

d = 12√P

d = 1.2√P

d = 2.3√P

0.01

0.35

1.2

0.12

0.23

0.1

1.1

3.8

0.38

0.73

1

3.5

12

1.2

2.3

10

11

38

3.8

7.3

100

35

12

12

23

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.

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Warranty

Appendix A

Limited one year warranty

Company position regarding the reprocessing and reuse of single-use only medical devices

Limited Warranty. Smith & 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 & 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.

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. 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.

In order to keep this product warranty in effect, Customer must promptly notify Smith & Nephew of any defects in writing within thirty (30) days of discovery of such defects or within one (1) year of the sales order. This warranty does not cover: (i) Products packaged or labeled by someone other than Smith & 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.

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.

OTHER THAN THE WARRANTY STATED ABOVE SMITH & 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 & 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 & NEPHEW, INC. SHALL IN NO EVENT BE LIABLE FOR ANY EXEMPLARY OR PUNITIVE DAMAGES.

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Appendix B Ordering information 66800039

VERSAJET II console • includes footswitch, power cord and user manual

66800040

VERSAJET II Exact handpiece

15°/14mm

66800041

VERSAJET II Exact handpiece

45°/14mm

66800042

VERSAJET II Exact handpiece

45°/8mm

66800043

VERSAJET II Plus handpiece

15°/14mm

66800044

VERSAJET II Plus handpiece

45°/14mm

66800045

VERSAJET II Plus handpiece

45°/8mm

66800472

VERSAJET II multi-function footswitch

66800474

VERSAJET II Hydrosurgery System user manual

66800979

VERSAJET II cart (only for IEC 60601-1:1988 + A1:1991 + A2:1995 Second Edition)

66800475

VERSAJET II replacement shelf (retrofit to 50800)

66800193

Power cord, North America

66800213

Power cord, United Kingdom

66800291

Power cord, Central Europe

66800302

Power cord, South Africa

66800303

Power cord, Australia/New Zealand

66801063

VERSAJET II Speed Stick (RPM verification) tool

To order, contact Customer Care at 1-800-876-1261 (USA only) or local Smith & Nephew representative

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