Fon: ++49 (0) 70 71 / 857 893-100

Fax: ++49 (0) 70 71 / 857 893 100

Email
info@smpgmbh.com
http: // www.smpgmbh.com

SMP GmbH Service fr Medizinprodukte

Hechingerstrasse 262 72072 Tbingen














3URMHFW1R

,QYHVWLJDWLRQRIWKHFOHDQLQJ
EHKDYLRU
RIELSRODUPDUVHDO5()PP
PDUVHDOKDQGOH5()PFDEOH

&RPPLVVLRQHGE\
./60DUWLQ*PE+&R.*
$P*DQVDFNHUE
8PNLUFK


ein Projekt des

in Kooperation m it

7DEOHRIFRQWHQWV
1. Overview: ................................................................................................................ 3
2. Objective of investigation ........................................................................................ 4
3. Conclusion .............................................................................................................. 4
4. Material and methods ............................................................................................. 5
4.1 Preparation of the test soil................................................................................. 5
4.2 Contamination ................................................................................................... 5
4.3 Cleaning ............................................................................................................ 6
4.4 Second Measurement with the Gamma camera ............................................... 7
4.5 Devices and reagents........................................................................................ 7
4.6 Instruments under investigation......................................................................... 7
5. Results.................................................................................................................... 8
5.1 Run 1 (29/08) .................................................................................................... 8
5.2 Run 2 (34/08) .................................................................................................. 10
5.3 Run 3 (39/08) .................................................................................................. 12
7. Appendix: Logger data.......................................................................................... 15

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 2 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

,QYHVWLJDWLRQRIWKHFOHDQLQJEHKDYLRU
2EMHFWLYHRILQYHVWLJDWLRQ
The objective of this experiment is, to evaluate the cleaning behavior of the bipolar
marseal and marseal handle with the radionuclide method.
The radionuclide method (RNM) is a non-destructive test procedure, which allows the
investigation of the cleaning behavior of tubular instruments and instruments with
hidden corners. After artificial contamination and cleaning of the inner surfaces of the
instrument as well as of the outside, residues can be made visible with the help of
gamma radiation. The basic idea is to label the test soil prior to the contamination of
the instrument. The exact distribution of the contamination can be checked and
documented before and after cleaning. For labeling macro albumins (known from the
lung perfusion scintigraphy) with radioactive 99m Technetium (Tc-99m) are used and
mixed with fresh coagulable blood.
5 counts/sec (Zr-value in tables of run 1 3; see chapter 5) is the threshold value for
excellent cleaning results. Values above 5 counts/sec can be tolerable, when a risk
analysis is performed, which takes into consideration the amount of contamination
and location before and after the cleaning process, the size of the device and the
way how it is been used.
&RQFOXVLRQ
The investigation shows that the handle and the tube of the bipolar MIC instrument
marSeal can be successfully cleaned. The DYHUDJH of the detected contamination is
5 count/s. The instruments placed forceps upside show a slightly increase of
contamination after cleaning.
Test result in SMP investigation No:11107011407 show, that a coagulation of
contaminated tissue after HF current impact does not cause a fixation of coagulated
blood on the instrument.

&OHDQLQJVWHSV
For the cleaning procedure the instrument is dismantled.
0DQXDOO\SUHFOHDQLQJ
Put the instruments in an ultrasonic bath for 5 minutes with 0,5%
neodischer Mediclean Forte (Dr. Weigert) at 40C
All parts of the instruments are flushed with a water jet pistol with cold tap
water for at least 10 sec. (3,8 bar static water pressure)
Scrub thoroughly using a soft brush
Cleaning of forceps and hinge with special KLS Martin tool

5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRU
Connecting the instruments to the MIC-rack of the washer disinfector
The instruments are cleaned with the following program (Vario TD, only the
cleaning steps are performed):
2 min pre-washing with cold water
emptying
5 min washing with 0,5 % neodischer Mediclean Forte (Dr. Weigert)by 55C
emptying
Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 4 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

3 min neutralizing with warm water (>40C)

emptying
2 min intermediate rinsing with warm water (>40C)
emptying

0DWHULDODQGPHWKRGV

3UHSDUDWLRQRIWKHWHVWVRLO
A flask Pulmocis is labelled by 400 MBq Technetium99m and filled up to the volume
of 5 mL with 0,9% sodiumchloride solution. Heparinized sheep blood and
protaminsulfat is added.
Mixing ratio of the test soil ingredients:
9 mL heparinized sheep blood (Acila GMN)
100 MBq Technetium99m (~ 0,9 mL)
150 L Protaminsulfat


&RQWDPLQDWLRQ
5 devices are marked with different colors.
Contamination is performed in plastic cup filled with the test-soil (1). The instruments
are submerged into the test-soil up to the hinge of the forceps (2). In this position the
forceps are affected 3 times.
After the contamination, the tubes are placed in a basket: 4 of the five tubes with
forceps down, one tube with forceps up to simulate the worst case. In this position it
is possible for the test soil to get inside the tube.
Additional the part of this tube, which is connected with the handle, is contaminated
by touching with contaminated gloves. In the next step this tube is assembled with
the handle to transfer the contamination inside the handle.
After 5 minutes coagulation is insisted, the instruments dried for 1 hour at room
temperature. Then the emission of the gamma quanta and the distribution on and
inside the instruments are measured by a gamma camera.

Figure 1: Example of the contamination procedure

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 5 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

&OHDQLQJ
The cleaning process starts 60 minutes after the contamination of the instruments.
&OHDQLQJVWHSV
For the cleaning procedure the instrument is dismantled.

0DQXDOO\SUHFOHDQLQJ
Put the instruments in an ultrasonic bath for 5 minutes with 0,5%
neodischer Mediclean Forte (Dr. Weigert) at 40C
All parts of the instruments are flushed with a water jet pistol with cold tap
water for at least 10 sec. (3,8 bar static water pressure)
Scrub thoroughly using a soft brush
Cleaning of forceps and hinge with special KLS Martin tool

5HSURFHVVLQJLQDZDVKHUGLVLQIHFWRU
Connecting the instruments to the MIC-rack of the washer disinfector
The instruments are cleaned with the following program (Vario TD, only the
cleaning steps are performed):
2 min pre-washing with cold water
emptying
5 min washing with 0,5 % neodischer Mediclean Forte (Dr. Weigert)by 55C
emptying
3 min neutralizing with warm water (>40C)
emptying
2 min intermediate rinsing with warm water (>40C)
emptying

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 6 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

6HFRQG0HDVXUHPHQWZLWKWKH*DPPDFDPHUD
After cleaning, the instruments are measured again using the gamma camera.
Regions of interest (ROI) are defined to allow subsequent determination of exact
areas of residual contamination in the individual instruments. The results are
documented and residual contamination is determined on the basis of the remaining
activity. Only the Zr value given in the table is used for the evaluation of the residual
contamination. The other values are data recorded by the camera, or which are
recorded during the test and which serve only as a basis for the calculation of the Zr
value.
Zr: counts/sec with correction of time-dependent gamma decay of metastable
technetium 99 (half-life 6,01 h)

'HYLFHVDQGUHDJHQWV
- washer disinfector (Miele)
- MIC rack (E 450)
- gamma camera (Gaede GMS 586)
- Curiementor-E (Semens)
- Ultrasonic bath Sonorex (Bandein)
- magnetic stirrer
- neodischer Mediclean Forte (Dr. Weigert)
- Syringe
- Beaker
- heparinised sheep blood Lot: 18477 (Acila GMN)
- Pulmocis (CIS bio international)
- Protaminsulfat (Acila GMN)
- Technetium99m
- gloves (Satin plus, Safe skin)
- Data logger for temperature and pressure Ebi -125A-PT (Ebro)
,QVWUXPHQWVXQGHULQYHVWLJDWLRQ
For the investigation five instruments are used.

Inner shaft

marseal Instrument

Handle

Figure 2 bipolar marseal Ref: 80-630-02 370 mm

marseal handle Ref: 80-630-09

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 7 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

5HVXOWV

5XQ
Instruments have been washed with a procedure described under 4.3.


 

 

)*  
+

,.-/"10&2

:0 ) 7 1<;.=6>!20!?

"g  * h
 #i0
6hjk:GGlBV

@<A=>< B+

"CD@! )!* 0 $3(6!EE$!F GH

D&!I !
) * 0 D '>+
P#"10</J2!: 
Q.

J * =&0</6!  )K1L 0<EMN< /&6 *(K!O 

J/7 '>

:0&/D0 5* Y /=BJ< 
:0&/D0 * 2D@
:0&/D0 * !
> 2
:0&/D0 *5
O * J
:0&/D0 * 8 * * 6 L
0&/D0 `* L 7 E
70 '@ * 
70 '@ * b2D@
70 '@ *  
O * J
70 '@ * $>!2
70 '@ * 1
 8 * * 6 L
70 '@ *  L 7 E
 #"10</J2!: 

Q.

:0&/D0 5* Y /=BJ< 
:0&/D0 * 2D@
 !/70<eA
:0&/D0 * >!2
 !/70<eA


!#"$&%'(

R ) = S<  8UT!>

3#546'/7980

after contamination

V. * * /

W3


I 
PX'2

E6

T

8150

264

1,4

150

Z[\

6608

264

1,4

150

Z\]

2860

299

1,4

150

[]

7848

299

1,4

150

Z9^!_

7487

299

1,4

150

Z]a

3001

3174

1,4

150

[]

3973

3243

1,4

150

cZ

2841

3243

1,4

150

[d

2001

3243

1,4

150

]'^

465

3174

1,4

150

W3


I 
PX'2

E6

T
\

R ) = S<  8UT!>

after pre-cleaning

V. * * /

84

210

1,4

128

150

103

1251

1,4

128

150

Z
^

195

189

1,4

128

150

:0&/D0 5* O* J

 !/70<eA

83

1251

1,4

128

150

109

210

1,4

128

150

:0&/D0 * 8 * * 6 L
 !/70<eA

89

1251

1,4

128

150

162

210

1,4

128

150

0&/D0 `* L 7 E
 !/70<eA

96

1251

1,4

128

150

266

189

1,4

128

150

131

1251

1,4

128

150

339

3174

1,4

132

150

303

3243

1,4

132

150

280

3243

1,4

132

150

303

3243

1,4

132

150

251

3243

1,4

132

150

f 
eNeE
70 '@ * b2D@
70 '@ *  
O * J
70 '@ * $>!2
70 '@ * 1
 8 * * 6 L
70 '@ *  L 
7 E

Z
^
Z

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 8 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

m!n5oCpq<rst&p!u:pvw
u:qtErDpqx5y vrw=t
s<u:pvw
uqtErDpqxzt2pD{
} vvpt!r~qNw
u:qtErDpqx!t2ppv
} vvpt!r~qNw
uqt&rDpqx5x sp
} vvpt!r~qNw
uqtErDpqx`px x 
} vvpt!r~qNw
u:qt&rDpqx`:~} wAp
} vvpt!r~qNw
tB} AAp
~qv'{!x pt2pD{
~qv'{!x pbx sp
~qv'{!x p!t2ppv
~qv<{!x ph9px x 
~qv'{!x ph:~D} wEp

in Kooperation m it

after cleaning

73

230

1,4

172

150

109

1341

1,4

172

150

104

230

1,4

172

150

95

1341

1,4

172

150

104

230

1,4

172

150

90

1341

1,4

172

150

150

230

1,4

172

150

115

1341

1,4

172

150

246

230

1,4

172

150

134

1341

1,4

172

150

310

3174

1,4

176

150

271

3243

1,4

176

150

242

3243

1,4

176

150

237

3243

1,4

176

150

230

3243

1,4

176

150

1RWRI5XQ
Instrument white to simulate the worst case. In this position it is possible for the test
soil to get inside the tube.(see chapter 4.2)

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 9 from 10
Publications or copies are only allowed of the complete report.

in Kooperation m it

ein Projekt des

5XQ
Instruments have been washed with a procedure described under 4.3.

:

'< 

 

.1&2

: ! 1<.=!2!?

g h#
h:B

#5' 9 

<A=<B

CD! ! $(!EED 

D&! !
 '
#1<2!:
.

= &!! 1 <EA< & (! B '

:&D =B<
:&D 2D
:&D !
2
:&D 5

:&D `
&D ` E
'
' b2D

' 
'


'

2

'
' E
#1<2!:
.

:&D =B<
:&D 2D
! <A
:&D !2
! <A
:&D 5 
! <A
:&D `
! <A
&D ` E
! <A

NE
' b2D

' 
'


'

2

'
'
E




= < U

after contamination

!5g&'(

N ='=

&

7610

288

1,4

150

9!

3120

288

1,4

150

2689

299

1,4

150

3624

276

1,4

150

3831

299

1,4

150

3709

3519

1,4

150

3374

3519

1,4

150

3544

3640

1,4

150

6999

3712

1,4

150



3519

1,4

150

N ='=

&

386

160

1,4

108

150

3919

= < U

after pre-cleaning

86

1071

1,4

108

150

235

144

1,4

108

150

87

952

1,4

108

150

96

160

1,4

108

150

84

1071

1,4

108

150

210

144

1,4

108

150

61

952

1,4

108

150

97

144

1,4

108

150

75

952

1,4

108

150

242

3519

1,4

112

150

261

3519

1,4

112

150

388

3640

1,4

112

150

466

3712

1,4

112

150

332

3519

1,4

112

150

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 10 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

#1<2!:
:&D5 =B<
:&D2D
!<A
:&D(!2
!<A
:&D5 
!<A
:&D` 
!<A
&D` E
!<A

NE
'! b2D
'!  '
'! $!2
'! 1 
' 1 E

in Kooperation m it

after cleaning

123

198

1,4

121

150

89

1170

1,4

121

150

107

198

1,4

121

150

91

1053

1,4

121

150

49

198

1,4

121

150

84

1170

1,4

121

150

123

198

1,4

121

150

83

1053

1,4

121

150

56

176

1,4

121

150

101

1053

1,4

121

150

220

3519

1,4

125

150

277

3519

1,4

125

150

321

3640

1,4

125

150

332

3712

1,4

125

150

274

3519

1,4

125

150

1RWRI5XQ
Instrument red to simulate the worst case. In this position it is possible for the test soil
to get inside the tube.(see chapter 4.2)

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 11 from 10
Publications or copies are only allowed of the complete report.

in Kooperation m it

ein Projekt des

5XQ
Instruments have been washed with a procedure described under 4.3.

:

 

 

.1&2

: ! 1<.=!2!?

g h#
h:B

#5' 9 

<A=<B

CD! ! $(!EED 

D&! !
 '
#1<2!:
.

= &!! 1 <EA< & (! B '

:&D =B<
:&D 2D
:&D !
2
:&D 5

:&D `
&D ` E
'
' b2D

' 
'


'

2

'
' E
#1<2!:
.

:&D =B<
:&D 2D
! <A
:&D !2
! <A
:&D 5 
! <A
:&D `
! <A
&D ` E
! <A

NE
' b2D

' 
'


'

2

'
'
E




= < U

after contamination

!5g&'(

N ='=

&

6073

288

1,4

150



7065

312

1,4

150



6441

288

1,4

150



4347

288

1,4

150

6290

312

1,4

150



7149

3082

1,4

150



4705

3128

1,4

150

3845

3082

1,4

150

2999

3082

1,4

150

3128

1,4

150

N ='=

&

180

1,4

86

150

4538

= < U
307

after pre-cleaning

61

882

1,4

86

150

391

180

1,4

86

150

882

1,4

86

150

200

1,4

86

150

63

882

1,4

86

150

346

180

1,4

86

150

67

882

1,4

86

150

90

200

1,4

86

150

71

882

1,4

86

150

314

3082

1,4

96

150

286

3128

1,4

96

150

283

3082

1,4

96

150

275

3082

1,4

96

150

516

3082

1,4

96

150

87
311

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 12 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

#1<2!:
:&D5 =B<
:&D2D
!<A
:&D(!2
!<A
:&D5 
!<A
:&D` 
!<A
&D` E
!<A

NE
'! b2D
'!  '
'! $!2
'! 1 
' 1 E

in Kooperation m it

after cleaning

291

180

1,4

131

150

61

882

1,4

131

150

223

180

1,4

131

150

68

882

1,4

131

150

239

200

1,4

131

150

47

882

1,4

131

150

275

180

1,4

131

150

50

882

1,4

131

150

83

180

1,4

131

150

75

882

1,4

131

150

285

3082

1,4

135

150

267

3128

1,4

135

150

261

3082

1,4

135

150

274

3082

1,4

135

150

314

3082

1,4

135

150

1RWRI5XQ
Instrument yellow to simulate the worst case. In this position it is possible for the test
soil to get inside the tube.(see chapter 4.2)

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 13 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

6. References:
<<2 2
5= 

 

Draft Standard Test Method for Validation of cleaning cycles for

reusable medical devices with lumens and hidden surfaces. This
test method is under the jurisdiction of ASTM Committee F04
Medical and Surgical Devices and is the direct responsibility of
Subcommittee F04.35 GI Endoscopes.
TIR 30

TIR 30 A compendium of processes, materials, test methods,

acceptance criteria for cleaning reusable medical devices

ISO 17664

Publication date:2004-03 Sterilization of medical devices - Information to

be provided by the manufacturer for the processing of resterilizable
medical devices

EN ISO 15883-1:2006

Publication date:2006, Washer/-disinfectors - Part 1: General

requirements, terms and definitions and tests; German version EN ISO
15883-1:2006

EN ISO 15883-2:2006

Publication date:2006 Washer/-disinfectors - Part 2: Requirements and

tests for washer/disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes receivers, utensils,
glassware, etc. (ISO 15883-2:2006); German version EN ISO 158832:2006

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 14 from 10
Publications or copies are only allowed of the complete report.

ein Projekt des

in Kooperation m it

$SSHQGL[/RJJHUGDWD

Fig.3: Pressure and temperature logger diagram

Project No.: 02208011403 Investigation of the cleaning behavior of bipolar marseal Ref. 80-630-02 and marseal handle Ref: 80630-09
page 15 from 10
Publications or copies are only allowed of the complete report.

KLS Martin Group

Karl Leibinger GmbH & Co. KG
78570 Mhlheim
Germany
Tel. +49 74 63 838-0
info@klsmartin.com

Stuckenbrock Medizintechnik GmbH

78532 Tuttlingen
Germany
Tel. +49 74 61 16 11 14
verwaltung@stuckenbrock.de

KLS Martin GmbH & Co. KG

79224 Umkirch
Germany
Tel. +49 76 65 98 02-0
info@klsmartin.com

Rudolf Buck GmbH

78570 Mhlheim
Germany
Tel. +49 74 63 99 516-30
info@klsmartin.com

KLS Martin France SARL

68000 Colmar
France
Tel. +33 3 89 21 66 01
france@klsmartin.com

Martin Italia S.r.l.

20059 Vimercate (MB)
Italy
Tel. +39 039 605 67 31
italia@klsmartin.com

Martin Nederland/Marned B.V.

1270 AG Huizen
The Netherlands
Tel. +31 35 523 45 38
nederland@klsmartin.com

Nippon Martin K.K.

Osaka 541-0046
Japan
Tel. +81 6 62 28 90 75
nippon@klsmartin.com

Gebrder Martin GmbH & Co. KG

Representative Office
121471 Moscow
Russia
Tel. +7 (499) 792-76-19
russia@klsmartin.com

KLS Martin L.P.

Jacksonville, Fl 32246
USA
Office Phone +1 904 641 77 46
usa@klsmartin.com

Orthosurgical Implants Inc.

Miami, Fl 33186
USA
Office Phone +1 877 969 45 45
sales@orthosurgical.com

Gebrder Martin GmbH & Co. KG

A company of the KLS Martin Group
Ludwigstaler Strae 132 D-78532 Tuttlingen
Postfach 60 D-78501 Tuttlingen/Germany
Tel. +49 7461 706-0 Fax +49 7461 706-193
info@klsmartin.com www.klsmartin.com

04.08 90-335-82-04 Printed in Germany Copyright by Gebrder Martin GmbH & Co. KG Alle Rechte vorbehalten Technische nderungen vorbehalten
We reserve the right to make alterations Cambios tcnicos reservados Sous rserve de modifications techniques Ci riserviamo il diritto di modifiche tecniche