CONTROL DOCUMENT

PROCESS NO. EWI-09-21

ellman International, inc. TITLE: EMC and Dento Test Procedure
REV: F
DATE: 9/23/2009
Step OPERATION/PROCESS
HYPOT Administratr 6/16/2009 11:37 AM
Test unit per EWI-10-07 attaching return lead to the low power stop as indicated below. Formatted Table

CALIBRATION
Calibration must be done daily before any measurements are done.
a) Turn on and Warm up the scope for at least 20 minutes
b) Remove Scope Probe from Channel 1 Input
c) Press Utility
d) Press System 5 times until Calibration is selected

e) Press Signal Path

f) Press OK Compensate Signal Path Press Signal Path

Calibration will take approximately 10 minutes to complete

RECALLING SETUP
a) Push Menu

b) Push Recall Setup

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 c) Push Setup 1. Setup parameters are listed below.

Parameter Setting
Horizontal Sweep 2 msec
Channel 1 100 Volts
Measurement: Select Measurement – RMS
Gating – Between Cursors
Set Cursor a to -7.52 msec
Set Cursor b Δ (Delta) to 16.6 msec
Acquire: Mode – Sample
Record Length – 1M Point
Trigger: AC Line
d) Push Menu Off twice to clear menus

SET-UP
a) Connect the Scope Probe to Channel 1 Input

b) Connect the load as shown with the Active Plug connected to the Scope Probe and the Ground
connected to the Antenna Plug

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 c) Connect the White Banana Plug to the Surgitron FINGERSWITCH ADAPTOR Jack as shown.

d) Connect the Green Banana Plug to the Green ANTENNA Jack, and the Black Banana Plug to the
Black ACTIVE Jack.

e) Turn on the Surgitron and allow to warm-up 1 Minute.

f) Set Volume on rear of unit to High.

CUT
a) Set the Surgitron Level to 1 and Mode to Cut.
b) Press the Footswitch and hold long enough to hear both tones (beeping and constant tone).
c) Check the Waveform. Fail if distortion or a defined 0V line is observed. Reference example
Pass/Fail Images below.
d) Observe Vrms from the Oscilloscope Display and convert to power using form QF-21-01. Verify
that power level falls within the following limits

SURGITRON DENTO
Setting Minimum Maximum Setting Minimum Maximum
Lo 0 9 Lo 0 7
1 0 11 1 0 7
2 21 31 2 10 16
3 37 55 3 18 28
4 49 73 4 25 37
5 58 86 5 31 47

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 6 66 98 6 38 56
7 69 103 7 42 64
8 70 106 8 45 67
9 72 108 9 49 73
Hi 74 110 Hi 50 76
e) For Medical units transfer the results of testing into the Quality Record found in the EMC
Hospital Manual
f) Wait at least 10 seconds
g) Repeat for levels 2 to HI.
CUT/ COAG
a) Set the Surgitron Level to 1 and Mode to Cut/Coag.
b) Press the Footswitch and hold long enough to hear both tones (beeping and constant tone).
c) Check the Waveform. Fail if distortion or a defined 0V line is observed in the modulated regions.
Reference example Pass/Fail Images below
d) Observe Vrms from the Oscilloscope Display and convert to power using form QF-21-01. Verify
that the power falls within the following limits.
SURGITRON DENTO
Setting Minimum Maximum Setting Minimum Maximum
Lo 0 8 Lo 0 4
1 0 8 1 0 4
2 12 18 2 8 12
6 3 25 37 3 13 19
4 34 52 4 17 25
5 42 62 5 22 34
6 46 70 6 27 41
7 54 80 7 31 47
8 56 84 8 34 52
9 59 89 9 38 56
Hi 62 92 Hi 38 58
e) For Medical units transfer the results of testing into the Quality Record found in the EMC
Hospital Manual
f) Wait at least 10 seconds
g) Repeat for levels 2 to HI.

COAG
a) Set the Surgitron Level to 1 and Mode to Coag.
b) Press the Footswitch and hold long enough to hear both tones (beeping and constant tone).
c) Check the Waveform. Fail if distortion or a defined 0V line is observed in the modulated regions.
Reference example Pass/Fail Images below
d) Observe Vrms from the Oscilloscope Display and convert to power using form QF-21-01. Verify
7 that power level falls within the following limits
SURGITRON DENTO
Setting Minimum Maximum Setting Minimum Maximum
Lo 0 4 Lo 0 4
1 0 4 1 2 4
2 6 8 2 5 7
3 7 11 3 6 10

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 4 17 25 4 10 14
5 19 29 5 11 17
6 23 35 6 14 20
7 26 38 7 16 24
8 28 42 8 18 26
9 29 43 9 18 28
Hi 30 44 Hi 20 30
e) For Medical units transfer the results of testing into the Quality Record found in the EMC
Hospital Manual
f) Wait 10 seconds and Repeat for levels 2 to HI.
FULGURATE
a) Move the Black Banana Plug to the White FULGARATE Jack set the mode to Coag.
b) Press the Footswitch and hold long enough to hear both tones (beeping and constant tone).
c) Check the Waveform. Fail if distortion or a defined 0V line is observed. Reference example
Pass/Fail Images below.
d) Observe Vrms from the Oscilloscope Display and convert to power using form QF-21-01. Verify
that power level falls within the following limits
SURGITRON DENTO
Setting Minimum Maximum Setting Minimum Maximum
Lo 0 7 Lo 0 4
1 5 7 1 0 4
2 10 16 2 6 8
3 18 28 3 7 11
4 25 37 4 17 25
5 31 47 5 21 31
8 6 38 56 6 25 37
e) For Medical units transfer the results of testing into the Quality Record found in the EMC
Hospital Manual
f) Wait at least10 seconds
g) Repeat for levels 2 to 6.
h) Set the level to 7
i) Press the Footswitch and hold long enough to hear both tones (beeping and constant tone).
j) Verify that RF is generated (waveform distortion is acceptable) and that the audio tone is
not distorted.
k) Wait at least 10 seconds.
l) Repeat for levels 8 to Hi.
m) Set Mode to Cut/Coag with Power Hi.
n) Repeat steps (i) through (k).
o) Set Mode to Cut with Power Hi.
p) Repeat steps (i) through (k).
Repeat (m) through (o) with Mode set to Cut and Power Hi
FINGERSWITCH ADAPTOR (EMC Unit)
9 a) Move the Black Banana Plug to the White FINGERSWITCH ADAPTOR Jack

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 b) Press the Footswitch
c) Check the Waveform at Hi for Cut, Cut/Coag and Hemo Modes. Fail if distortion or a defined
0V line is observed. Reference example Pass/Fail Images below.
Labels
a) Take off the vendor part number on bottom of foot pedal (round pedal only) using alcohol
b) Turn off machine, unplug and discharge by pressing foot pedal
c) Fill out the declaration of conformity and put under handle (EMC: DCC-50-05, Dento:
DCC-50-04)
d) Cable tie the foot pedal wires
e) On all EMC units Place UL label (UL483E) and caution/warning label (DMV237) on unit
(see picture for placement)

f) Use respective serial number for corresponding Model shown in the chart (for placement
10 see picture)

g) Wrap a caution label (D6DMV-1128) around foot pedal wire

h) On all EMC units except for Japan, place another label (B1M-1012) on top of unit
i) On all EMC units, Inside Cover place an operator label (LS-76-12) and Fingerswitch
adaptor label (DMV204) under the fingerswitch plugs.
j) Final check on unit, make sure all screws in tight, rubber bumpers are not loose, and there
are no scratches or scuffs
k) Fill out the production traveler paper and check it over
l) Place a green tag around a front knob to indicate that the unit passed inspection, if failed use
a red tag
Hospital Units Only
11 Using QF-21-01 transfer the results of testing into the Quality Record found in the EMC
Hospital Manual

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 Administratr 6/16/2009 11:38 AM
Deleted:
Administratr 6/17/2009 8:48 AM
Formatted: Font:Not Italic

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 Cut Mode Pass Cut Mode Fail

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 Cut/Coag Mode Pass Cut/Coag Mode Fail

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 Cut/Coag Mode Pass Cut/Coag Mode Fail

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 Coag Mode Pass Coag Mode Fail

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 Coag Mode Pass Coag Mode Fail

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ellman  international inc.
REVISION CONTROL SHEET

TITLE: EWI-09-21 EMC-09-21

ISSUE DATE APPROVAL REVISIONS

A 7/28/08 Initial Release
B 12/10/08 JMA Significant rewrite. Added Pass/Fail example
images
C 12/15/08 Changes were made to the Pass/Fail example
images
D 4/30/09 The Addition of Step 12, Audio testing for
Japan
E 6/19/09 JMA Updates to Step 12 per further discussions
with Japan

** PROPRIETARY INFORMATION **
This document contains proprietary information that may only be distributed or routed within
ellman  international inc. except with the written permission of the company CEO or President.

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