B|BRAUN

Internal message
to
Mr. Messmer, RCC
Mr. Storr, BBM UK
from
RCC
Sign Phone Date
2005-12-23

Test protocol about instruments from Aesculap from the

clinic in Glasgow (UK) with Dot-Matrix-code from an
third party company.

The Services is defined under Q-Report-No. 900025610.

It was arranged to examine the instruments after 5, 10 and 20

cycles for possible corrosion on Dot-Matrix-Code and to documen-
tation by photos.
Also it was arranged the check of water quality and documenta-
tion the content of the water.

The following values are relevant:

Iron, phosphate, chloride, silicic acid, ph-value and conduc-
tance of the water.

Goal: Corrosion resistance in the cleaning process

according to the RKI-rules (Robert-Koch-
Institute).

Sample: several instruments with the following article

no.:
Aesculap: BB073R, OL610R, BC323R, BC654R, FM194R,
BD154R, BM066R, BH111R
Third party: DOWNS-MD-235-04Z

Test: ACS-cleaning and sterilization program

Requirements: 5, 10, 20, 150 Cycles

Test equipment: Automatic Cleaning and Sterilization device

Wet sterilization:
With 3 several sterilization agents – always changing after 20 cycles.
1) Helipur B.BRAUN with phenol without ultrasonicate
2) Gigasept FF Schülke & Mayer free from formaldehyde
with ultrasonicate
3) Lysetol med Schülke & Mayer free from aldehyde
with ultrasonicate

Cleaning
Program 1, WD390-U1T with Helimatic Cleaner alcaline 0,5 %,
by 55°C cleanse, with Helimatic Neutralizer C
neutralise 0,15 %, with 70°C rinse,
by 94°C Thermo sterilization and
by approx. 100 °C approx. 20 minutes desiccate.

Sterilization
ST-666-HS2 with program: FRVV-VMT 134°C RKI with 18 min.
dwell time and/or
FRVV-VMT 134°C Inst. with 5 min. dwell time

Result: After 5, 10 and 20-cycles we has the articles checked

visually and they were okay (see the images in the ap-
pendix). The instruments have now a moderate discol-
oration. This can be caused by diversion of cleaner or
a bad water quality.
After 150 cycles we have stopped the test.

Notes: An current documentation and the final review found in

the appendix.

Appendix: Images of 5, 10 und 20 cycles

Result:

After 150 washing cycles (with the process parameter from the
beginning) we don’t found corrosion on the Dot-Matrix-Code. But
in the last washing process was the flushing with water not op-
timal and the instrument change the color of the surface in
black. Reason was perhaps the contamination with the cleaner in
the last flushing. The coloring of the surface isn’t an problem
of corrosion, it is an optical lack.

The result form our test process isn’t an guarantee for problems
of the surface quality with other washing parameters. We take
. . .
over no guarantee to apply an Dot-Matrix-Code on Aesculap in-
struments.

Also in attention that the instruments were not cleaned under

real conditions. Starting point was we cleaned not contaminated
instruments step by step in the washing process.

Possible appearing corrosion in the Dot-Matrix-Code of contami-

nated instruments (example: protein, blood, secretions saline
solution, chloric medicine, etc) cannot be tested under our lab
conditions.

We send the instruments to you in the present condition and new

instruments free of charge (for replacement).

Result of water analysis :

water -
Sample A = final rinse final rinse autoclav
Washer desinfector EN 285 Sample A Sample B entity
Sample B = water auto- Speise-
clav wasser clear clear

Washing machine

Eisen Iron ≤ 0,2 0 0 mg/L

Phosphat / phosphate ≤ 0,5 0,5 0 mg/L
Chlorid / chloride ≤ 2 15 0 mg/L
Kieselsäure / silicic acid ≤ 1' 1 0,2 mg/L
ph - Wert / ph value 5-7 6,22 5,66 ph
Leitfähigkeit/conductivit
y ≤ 15 293 153 µS/cm

The part of the silicic acid (1,0mg/liter) in the water probe

from the last flushing is marginal to high. We has found also
0,2 mg/liter in fresh water of the sterilizer. We think the rea-
son is the contamination with the cleaner in the last flushing.

These values can lead with the time to silicate, but isn’t an
problem of corrosion, it is an optical lack.

. . .
CL = chlorine chloride are also components of the water.
The concentration of chloride is contingent on the cycle of the
refreshing from the old
water. This is to be seen also in the measured values of the wa-
ter analysis (see table
more than 7 power of the approximate value of the German Insti-
tute for Standardization EN 285.)

Chloride attacks locally the passive layer of instruments, these

penetrate the layer and the result is corrosion. This is a big
danger for the instruments and the Dot-Matrix-Code.

The concentration of chloride in the water of the last flushing

(sample A) hazard a guess that not take distilled water but only
take drinking water for the cleaning and disinfection. This is a
big danger for corrosion.

Have you any questions you can contact Mr. Messmer and Mr. Lom-
pat.

Best regards,

Aesculap AG &Co KG
Complaint Center

Armin Meßmer Christian Lompat

Complaintspecialist SMS Services

Tel. 07461 95-2821 Tel. 07461 95-1056

Fax 07461 95-1555 Fax 07461 95-1200

armin.messmer@aesculap.de chris-
tian.lompat@aesculap.de

. . .
Appendix:

before the check: BH111R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: Ol610R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: FM194R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: BC654R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: BC323R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: BM0066R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: BB073R

after 5 Wash cycles after 10 Wash cycles

. . .
after 20 Wash cycles

before the check: BD154R

after 5 Wash cycles after 10 Wash cycles

after 20 Wash cycles

. . .
before the check: Downs MD-235-04-Z (AN913R)

after 5 Wash cycles after 10 Wash cycles

. . .
after 20 Wash cycle