Aquamantys System Generator Guide Rev A Aug 2012

Table of Contents

Test Leads Required... 1 Aquamantys® Generator Adjustments... 1 RF Activation... 2 RF Leakage Current... 4 Pump Head Rotation to Verify Flow Rate Accuracy... 11 Load Pump Tubing Segment into Pump... 15

Intended Use of this Document WARNING: The information contained in this document is intended for the use of qualified personnel only. Biomedical technicians (e.g., ICC Certified Biomedical Equipment Technician [BMET]) or similar personnel performing the steps outlined here shall be fully familiar with all documentation on the functions, operations, warnings and components of the Aquamantys® System. Serious injury can result if the activities described in this document are attempted by unqualified persons and if warnings identified in the text are neglected.

Note: The information contained in this document was accurate at the time of publication. Medtronic reserves the right to make changes to the product described in this manual without notice and without incorporating those changes into any products already sold. No part of this document may be reproduced in any manner, or transmitted by any form or means electronic or mechanical, for any purpose without the express written permission of Medtronic Advanced Energy.

Test Leads Required 1 (1) Long red lead with (2) 4mm ends 2 (1) Long black lead with (2) 4mm ends 1

2

4

3 (1) Long lead with (1) 4mm end and (1) banana clip

3

4 (1) Short red lead with (1) 4mm end and (1) 2mm end

Aquamantys® Generator Adjustments Power on Aquamantys generator, adjust power up and down

Adjust flow settings

1

RF Activation When 2mm connector #1 is shorted to 4mm connector #1, the Aquamantys® bipolar RF output will be active from 4mm connector #1 to 4mm connector #2

Figure 1 Aquamantys bipolar output socket; RF output activation

1

1 Insert red (active) and black 4mm test lead ends into bipolar socket

1

2 3

2 2mm pin will activate RF when inserted into center hole of bipolar socket 3 Insert short red 4mm end of test lead into long red lead

2

4 To activate RF output, insert 2mm pin of short red lead into 2mm center hole of bipolar socket

5

5 Blue bipolar active LED will light up and stay lit while RF is activated

4

6

6 WARNING: metal of loose ends of test cables become extremely hot and will cause burn injury if contact with skin is made while RF is active

8

7

7 To deactivate RF output, remove 2mm pin from bipolar socket 8 Bipolar active LED will go off

3

RF Leakage Current* WARNING: Use extreme caution during this test. Metal ends of test leads are hot during RF activation and will cause burning if in contact with skin!

1

1

1 Power on Aquamantys® generator, adjust power to 200W, and flow rate to high

2 Power on electro-surgical safety analyzer (power meter) and adjust resistance to 200Ω

2 2

3

3 Insert opposite end of black test lead into inactive port of power meter

Do not attach red test lead from bipolar socket to power meter at this time

*Electrosurgical power meter shown in this section is for illustrative purposes only. Customer test equipment may differ. 4

4

5

4 Connect 3rd test lead with alligator clip end to the earth ground stud on the back of the Aquamantys® generator

5 Insert opposite end of 3rd test lead into active port of power meter

6 Activate RF output

6

6

5

7 Read current measurement on power meter display 7

This reading must be below 100mA

8 Remove black test lead from inactive port of power meter 8

9 Insert opposite end of red test lead connected to active side of bipolar socket into the inactive port of the power meter, read current measurement on power meter display

9

10

10 This reading must be below 100mA

6

11

11 Deactivate RF output and remove 3rd test lead from power meter and Aquamantys® generator earth ground stud

11

RF Output Power:

12 Set power of the Aquamantys generator to 200W

12

13 Make sure RF output is not active at this point

13

7

14 Insert red test lead into active port of power meter and black test lead into inactive port 14

15 Adjust resistance on the power meter to 50Ω

16 15

16 Activate RF power and read measurement on power meter display Measurement should be 200W +/- 10%

17

17 Deactivate RF power after each measurement; power can only be adjusted when RF is inactive

17

18 Repeat measurement with 100Ω resistance 19 18

19 Measurement should be 200W +/- 10%

8

20 Repeat measurement with 150Ω resistance 21 20

21 Measurement should be lower than previous readings at lower resistance (see power curve below)

Output Power versus Resistance

22

22 Adjust power setting on the Aquamantys® generator to 100W

9

23 Take measurements at 50Ω 24 23

24 Measurement should be 100W +/- 10%

25 Take measurement at 100Ω 26 26 Measurement should be 100W +/- 10%

25

27 Take measurement at 150Ω 28 27

28 Measurement should be lower than previous readings at lower resistance (refer back to power curve above)

10

Pump Head Rotation to Verify Flow Rate Accuracy

1

1 Close pump head by moving and locking the pump head lever down toward the rear of the pump generator

2 2 Remove grommet from pump head

3

3 Mark a visual reference point

4 Or use a piece of tape and stick to pump shaft 4

11

5 Set the Aquamantys® generator power to 200W

5

6 6 Adjust flow rate to Low

7 Activate RF output 7

8 Using a stopwatch as a timer, count number of complete revolutions of pump shaft in 15 seconds

7

8 Deactivate RF output between measurements

Minimum revolutions = 17 Maximum revolutions = 23

9 9 0:1500

12

10 Count pump shaft revolutions in 15 seconds at Medium flow rate 10

10

Minimum revolutions = 22 Maximum revolutions = 30

11 Count pump shaft revolutions in 15 seconds at High flow rate 11

11

Minimum revolutions = 27 Maximum revolutions = 36

13

12 Count pump shaft revolutions in 15 seconds at Prime rate 12

12 Minimum revolutions = 31 Maximum revolutions = 42

Saline Flow Rate versus Power Setting

13 Replace grommet

13

14

Load Pump Tubing Segment into Pump

1

1 Open pump head by moving pump head lever toward front of the Aquamantys® generator

2 With black tubing insert facing toward front of Aquamantys generator and white tubing insert facing toward back of Aquamantys generator, insert tubing segment into pump head

3

2

4

3 Black corner of pump head label points to direction of black tubing barp, white corner of pump head label points to direction of white tubing barp

4 Line tubing up inside of guide pins in front and back and hold in place while closing pump head

15

For further information, please call 866-777-9400 or 603-742-1515. You may also consult our website: www.medtronic.com/advancedenergy Medtronic Advanced Energy LLC 180 International Drive Portsmouth, NH 03801 USA www.medtronic.com/advancedenergy Tel: (866) 777-9400 Fax: (866) 222-0900

International Telephone Numbers Adriatic Regional Office 385-1-488-1120 Australia 1800-668-670 Baltic Regional Office 37-1-67560226 Belgium 32-2456-09-09 Canada 1800-217-1617 China 86-21-50800998 Czech Republic 420-2-9657-9580 France 33-470-679-800 Germany 49-2159-8149-209

Greece 30-210-67-79-099 Hong Kong 852-2919-1312 Hungary 36-30-5052987 India 91-22-26836733 Israel 972-9-972-4400 Italy 39-02-24137-324 Japan 81-3-6430-2017 Korea 82-2-3404-3600 Lebanon 961-1-370-670 Luxembourg 32-2456-09-09

Netherlands 31-45-566-8800 Poland 48-22-4656900 Russian Federation 7-495-580-73-77 Singapore 65-6776-6255 South Africa 27-11-466-1820 Spain 34-91-625-05-40 Taiwan 886-2-2183-6000 UK 44-1923-205-166 USA 1-603-742-1515

© 2012, Medtronic, Inc. All rights reserved. Aquamantys® is a registered trademarks of Medtronic, Inc. 70-10-1399 8.12 Rev A

Caution: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions For Use (IFU) that accompany Aquamantys3 disposable devices and/or the Aquamantys3 System User Guide.