VERSAJET Hydrosurgery System Models 50700 and 50750 Console Performance and Safety Check Guide

1.0 Purpose 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 & Nephew customer care representative or sales representative to resolve all console problems.

2.0 Scope 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.

3.0 Equipment Optical Tachometer

Ametek 1726 or equivalent (hospital is responsible for purchase) Electrical testing equipment (hospital responsible for purchase) RPM verification tool (speed stick) Smith & Nephew (contact your local sales representative)

4.0 Performance check procedure A checklist is provided at the end of this document to record the results of the following checks. 4.1 4.1.1 4.1.2 4.1.3 4.1.4

4.1.5 4.1.6 4.1.7 4.1.8 4.1.9

Physical appearance check Make sure console is unplugged from electrical power. Check console for visible dents, cracks or missing pieces. Check that fan slots are free from obstructions, dust or foreign materials. 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. Check that the black console lever on the 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 loose 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.

4.2 4.2.1 4.2.2

4.2.3 4.2.4 4.2.5 • •

4.2.6 •

•

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 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. Off when footswitch connector is inserted. Note: lamp “on” signals a system error that will prevent the console from operating

Console control / display panel

Error lamp indicators

Main power switch

Power level switches

Footswitch connection

4.3 4.3.1 4.3.2 4.3.3

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).

Step 1

Step 2

Step 3

Step 4

4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9

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 5.1.1 5.1.2

5.1.3

Electrical testing check (also see product manual) Ensure the console and test equipment are set to the same input voltage setting prior to conducting electrical testing. Connection to “mains” grounding is accomplished through use of the grounding post located on the back of the console (see following diagram) 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: Classification: Requirements:

Test Ground integrity Earth leakage Earth leakage Enclosure leakage Enclosure leakage Patient leakage Patient leakage Input VAC applied to patient applied part

model 50700 and 50750 – VERSAJET™ console class I / type BF equipment IEC 60601-1

Equipment Condition Normal Normal Single fault Normal Single fault Normal Single fault Single fault

Limit at 120 V -50700 0.2 Ohms < 250 µ Amp < 500 µ Amp < 50 µ Amp < 250 µ Amp < 50 µ Amp < 250 µ Amp < 2500 µ Amp

Limit at 240V -50750 0.2 Ohms < 500 µ Amp < 1000 µ Amp < 100 µ Amp < 500 µ Amp < 100 µ Amp < 500 µ Amp < 5000 µ Amp

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 patient 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 & Nephew customer care representative or sales representative to resolve all console problems.

VERSAJET™ Console performance and safety checklist Steps

Physical Appearance Check

Yes

No

Comments

Yes

No

Comments

Yes

No

Comments

Yes

No

Comments

Yes

No

Comments

Caution: unit is unplugged and placed on bench for this step 1

Check Console for visible Dents, Cracks, Missing pieces

2

Check that ventilation slots are free from Obstructions, Dust or Foreign Materials

3

Check that labels and markings are intact and ledgible with no smudges

4

Check that Console Knob on UI (User Interface) rotates freely between 4 and 6 o’clock position

5

Check that On/Off Rocker switch moves to each position and remains in place

6

Check Foot Switch and attached cord for signs of turn or missing insulation

7

Check Foot Switch Mechanical Operation for Engage and Disengage by depressing and releasing

8

Inspect Power Cord for any frayed or missing insulation and bent , loose or missing plug blades or earth/ground System Diagnostics Check Note: unit is plugged in and placed on bench for this step

9

Adjust main power switch to ON and OFF positions

10

Verify console defaults to power level “1” when unit is turned on main front power switch.

11

Verify the unit power level value changes when arrows are depressed – there are 10 settings

12

Verify that the “Door” error lamp is “on” when door is at 4 o’clock posiion

13

Verify that the “Door” error lamp is “off” when door is at 6 o’clock posiion

14

Verify the “Pedal” error lamp is “on” when the foot switch is not plugged in

15

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

16

Turn main power switch switch to On Position

17

Turn knob on User Interface to “Open” position

18

Insert the “Speed Stick” in the User Interface until fully seated

19

Set Console to its Lowest setting (1)

20

Depress Footpedal allowing motor and transmission to cycle

21

Measure Speed per Console Speed Check Instructions

22

Set Console to its Highest setting (10)

23

Depress Footpedal allowing motor and transmission to cycle

24

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

25

Turn main power switch to On Position

26

Attach test leads to Ground Plug and UI (User Interface) as per electrical testing instructions

27

Take readings as per electrical teseting instructions to check if leakage is occuring

28

Disconnect test leads, and turn main power switch to off position

29

Unplug power cord from outlet and from back of console

30

Overall Physical Appearance showed no anomalies and unit is clean

31

Basic Functional Setup indicates functions evaluated are operational

Summary of results

32

Console Speed verification meets spec as defined in Hospital Test Protocol

33

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 If any of the Summary Results are “NO” this could be an indication of a need for Service or Repair Please contact your Smith & Nephew Customer Care Representative immediately and have this report available at time of call

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