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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

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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.
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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.

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For the cleaning procedure the instrument is dismantled.
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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

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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


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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

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

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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

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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)

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- 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)
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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

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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.

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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.

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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

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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.

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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

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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