Medtronic PULSAR User manual

PULSAR Generator Preventive
Maintenance Guide

Intended Use of this Document

WARNING: The information contained in this document is intended for the use of qualied

personnel only. Biomedical technicians (e.g.,
[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 PULSAR/
PULSAR ll Generator. Serious injury can result if the activities described in this document
are attempted by unqualied persons.

ICC Certied Biomedical Equipment Technician

PULSAR Generator Preventive Maintenance Procedure

The PULSAR (and PULSAR II) Generator provides radio frequency (RF) energy to
a disposable electrosurgical device. This combined system is used to perform
electrosurgery. The generator is capable of delivering multiple CUT and COAG
modes at various power levels when connected to a PEAK PlasmaBlade™
disposable device. Every disposable device (PEAK PlasmaBlade) has a memory
chip with ten set points for CUT modes and ten set points for COAG modes.
This chip species the output power for each set point. The generator reads this
memory chip to deliver RF power.

Equipment Required

The following equipment will be required to complete the output power
accuracy testing:

• PULSAR or PULSAR II generator

• A neutral electrode (return pad) connector with the pad cut o and the

two leads shorted together.

• PEAK PlasmaBlade disposable device (any one of PEAK PlasmaBlade 4.0,

3.0S, TnA, Needle, or PLUS).

• Electrosurgical analyzer (ESU) (capable of measuring RF output at 1MHz
and 460KHz).

• Oscilloscope and current sensing coil (both with 50 MHz capability).

Note: This equipment is required for cut modes 1-5 on both generator models.

Power Output Tests

See Appendix on page 4 for test procedure.

The Power Output Tests provide a means for the user to verify the accuracy of the RF energy output. The procedure to measure
output power is as follows:

1. Connect the PEAK PlasmaBlade device to the generator under test.

2. Connect the tip of the PEAK PlasmaBlade device (metal needs to be exposed) to the ESU leads using an alligator clip.

3. Connect the shorted leads of the neutral electrode to the ESU leads using an alligator clip.

4. Set the load on the ESU to the value indicated on the appropriate table, (Table 1 for PULSAR II and Table 2 for PULSAR I).

Refer to the ESU’s Instruction manual for set up instructions.

5. Power on the generator and adjust to the appropriate set point per the table.

6. Press the button (yellow for CUT and blue for COAG) on the PlasmaBlade device to activate RF. Measure the output power on

the ESU. Refer to Tables 1 and 2 for accuracy of measured power depending on the type of device connected.

7. This should be repeated for all the values highlighted in blue italics at a minimum. Other values are presented for
additional testing.

8. Per IEC 60601-2-2:

a. 201.12.1.101 Accuracy of output control setting

For output powers in excess of 10% of the RATED OUTPUT POWER, the actual power as a function of the load resistance and
output control setting shall not deviate from that shown in the diagrams specied in 201.7.9.3.1 by more than +/- 20%.

2

Table 1. Pulsar II Power Output Specs

Setting Mode Power (Watts) Impedance (Ohms) Tolerance

Cut 1 Low Cut 1 0.5 100 *None Prescribed

Cut 2 Low Cut 1 2 100 *None Prescribed

Cut 3 Low Cut 1 6 100 +/- 20%

Cut 4 Low Cut 1 10 100 +/- 20%

Cut 5 Low Cut 1 20 100 +/- 20%

Cut 6 Medium Cut 20 400 +/- 20%

Cut 7 Medium Cut 35 400 +/- 20%

Cut 8 Medium Cut 50 400 +/- 20%

Cut 9 High Cut (Blend 1) 25 400 +/- 20%

Cut 10 High Cut (Blend 2) 50 400 +/- 20%

Coag 1 Low Coag 1 15 400 +/- 20%

Coag 2 Low Coag 1 20 400 +/- 20%

Coag 3 Low Coag 1 25 400 +/- 20%

Coag 4 Low Coag 1 30 400 +/- 20%

Coag 5 Low Coag 1 35 400 +/- 20%

Coag 6 High Coag 30 500 +/- 20%

Coag 7 High Coag 35 500 +/- 20%

Coag 8 High Coag 40 500 +/- 20%

Coag 9 High Coag 45 500 +/- 20%

Coag 10 High Coag 50 500 +/- 20%

* Max Power setting for this mode is 40W, therefore is not required to be within 20% tolerance according to IEC 60601-2-

2 due to it being less than 10% of the max power setting.

Table 2. Pulsar I Power Output Specs

Setting Mode Power (Watts) Impedance (Ohms) Tolerance

Cut 1 Low Cut 1 0.5 40 *None Prescribed

Cut 2 Low Cut 1 2 40 *None Prescribed

Cut 3 Low Cut 1 6 40 +/- 20%

Cut 4 Low Cut 1 10 40 +/- 20%

Cut 5 Low Cut 1 20 40 +/- 20%

Cut 6 Medium Cut 20 600 +/- 20%

Cut 7 Medium Cut 35 600 +/- 20%

Cut 8 Medium Cut 50 600 +/- 20%

Cut 9 High Cut (Blend 1) 25 600 +/- 20%

Cut 10 High Cut (Blend 2) 50 600 +/- 20%

Coag 1 Low Coag 1 15 600 +/- 20%

Coag 2 Low Coag 1 20 600 +/- 20%

Coag 3 Low Coag 1 25 600 +/- 20%

Coag 4 Low Coag 1 30 600 +/- 20%

Coag 5 Low Coag 1 35 600 +/- 20%

Coag 6 High Coag 30 1000 +/- 20%

Coag 7 High Coag 35 1000 +/- 20%

Coag 8 High Coag 40 1000 +/- 20%

Coag 9 High Coag 45 1000 +/- 20%

Coag 10 High Coag 50 1000 +/- 20%

* Max Power setting for this mode is 40W, therefore is not required to be within 20% tolerance according to IEC 60601-2-

2 due to it being less than 10% of the max power setting.

3

Appendix

Procedure for measuring the Pulsar Generator output power at Low Cut settings.

Due to the low duty cycle characteristics of the low cut settings (Cut 1 through 5) of the Pulsar generator, it is
necessary to follow these instructions to accurately measure the true rms output power for these settings.

Equipment Required:

• Pulsar Generator and PEAK PlasmaBlade hand piece

• Oscilloscope

• Current sensing coil (i.e.: Pearson Wide Band Current Monitor model 4100 or similar)

• 100 ohm non-reactive resistive load - Pulsar II

• 40 ohm non-reactive resistive load - Pulsar I

Test Setup:

Load (100Ω or 40Ω)

Use the test conguration above, keeping all interconnecting leads as short as possible. Set the oscilloscope x-axis
time base to 1μs/division and the measurement to volts rms.

Procedure:

Set the Pulsar generator to the desired setting (Cut 1
through 5) and activate the Cut (yellow) nger switch on
the PEAK PlasmaBlade device. Adjust the trigger and delay
on the oscilloscope to capture the rf signal with no “o”
time in the screen. See the example screen to the right:

Record the rms amperage indicated on the oscilloscope.

4

Calculate the resulting power (Watts) utilizing the equation and table below:

2

( l

x Duty Cycle ) x R

I = Amps rms

R = See indicated loads in Tables 1 and 2.

Note: Equation into Spreadsheet example:

Table 3: Duty Cycle for Pulsar Generator (PEAK Plasmablade 4.0 & 3.0S) setting

Setting Duty Cycle “On” Time Repeat Cycle

Cut 1

Cut 2 0.0072

Cut 3 0.0144

Cut 4 0.0235

Cut 5

Notes:

For accuracy of output power measurement, IEC 60601-2-2 states:

201.12.1.101 Accuracy of output control setting

For output powers in excess of 10% of the RATED OUTPUT POWER, the actual power as a function
of the load resistance and output control setting shall not deviate from that shown in the diagrams
specied in 201.7.9.3.1 by more than ± 20%.

0.0017 18 μs 40100 μs

38 μs

50 μs

62 μs

0.0353

i.e. (2.4^2 x 0.0353) x 100 = 20.33 Watts

76 μs

5261 μs

3461 μs

2640 μs

2150 μs

5

70-10-1231 Rev C

© Copyright 2013

Medtronic Advanced Energy LLC.

© 2013, Medtronic, Inc. All rights reserved. PEAK, PEAK PlasmaBlade and PULSAR are registered and/or trademarks of Medtronic, Inc.
U.S. Patent Nos. 6,135,998, 6,730,075, 6,780,178, 7,238,185, 7,357,802, 7,736,361, and 7,789,879. Additional patents pending.

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.

2014/02

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 PEAK PlasmaBlade™ disposable devices and/or the PULSAR/PULSAR ll Operator’s Manual.

Medtronic Advanced Energy LLC

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Portsmouth, NH 03801 USA
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www.medtronicadvancedenergy.com

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