28
5.11 Overview of validated procedures
The following procedures have been validated as suitable for
processing the product:
•
Manual cleaning/disinfection with the detergent Cidezyme
and disinfectant Cidex OPA (Johnson & Johnson Medical
Limited, Gargrave, Skipton).
– Cidezyme: Dosage 1.6%, 5 minutes exposure time at
room temperature.
– Cidex OPA: Dosage 0.3%, 12 minutes exposure time at
20 °C.
•
Machine cleaning and disinfection in a G 7836 CD disinfector
(Miele & Cie. KG, Gütersloh, Germany) with the cleaning
agent neodisher mediclean forte (Dr. Weigert GmbH & Co.
KG, Hamburg, Germany).
– neodisher mediclean forte: Dosage 0.5%, 5 minutes ex-
posure time at 55 °C
– Disinfection: 5 minutes at 90 °C.
•
Sterilization in an autoclave Systec V-150 (Systec GmbH,
Linden/Germany).
– Steam sterilization with saturated steam, fractionated
vacuum procedure, 3 minutes, 132 °C, 3 bar.
Erbe recommends the processing procedures described in these
instructions for use. Equivalent different procedures are possible
if not explicitly excluded. It is incumbent on the user to ensure
the suitability of the actual procedures used by means of suit-
able measures (e.g. validation, routine monitoring, check of ma-
terial compatibility).
6
Disposal
Dispose of the product, packaging material and accessories (if
available) in accordance with the national guidelines and legis-
lation applicable in each case.
OBJ_DOKU-169544-013.fm Seite 28 Mittwoch, 17. März 2021 4:45 16
Summary of Contents for 20192-094
Page 6: ...6 OBJ_DOKU 169544 013 fm Seite 6 Mittwoch 17 M rz 2021 4 45 16...
Page 30: ...30 OBJ_DOKU 169544 013 fm Seite 30 Mittwoch 17 M rz 2021 4 45 16...
Page 44: ...44 OBJ_DOKU 169544 013 fm Seite 44 Mittwoch 17 M rz 2021 4 45 16...
Page 95: ...95 1 Erbe Erbe 1 1 1 2 2 1 3 OBJ_DOKU 169544 013 fm Seite 95 Mittwoch 17 M rz 2021 4 45 16...
Page 99: ...99 5 3 1 5 4 5 5 1 5 6 2 bar OBJ_DOKU 169544 013 fm Seite 99 Mittwoch 17 M rz 2021 4 45 16...
Page 104: ...104 x 1 1 X CE OBJ_DOKU 169544 013 fm Seite 104 Mittwoch 17 M rz 2021 4 45 16...
Page 128: ...128 OBJ_DOKU 169544 013 fm Seite 128 Mittwoch 17 M rz 2021 4 45 16...
Page 140: ...140 OBJ_DOKU 169544 013 fm Seite 140 Mittwoch 17 M rz 2021 4 45 16...
Page 152: ...152 OBJ_DOKU 169544 013 fm Seite 152 Mittwoch 17 M rz 2021 4 45 16...
Page 176: ...176 OBJ_DOKU 169544 013 fm Seite 176 Mittwoch 17 M rz 2021 4 45 16...
Page 191: ...191 1 Erbe Erbe 1 1 1 2 2 1 3 OBJ_DOKU 169544 013 fm Seite 191 Mittwoch 17 M rz 2021 4 45 16...
Page 194: ...194 5 5 1 2 2 95 C 138 C OBJ_DOKU 169544 013 fm Seite 194 Mittwoch 17 M rz 2021 4 45 16...
Page 195: ...195 5 2 5 3 1 5 4 5 5 1 2 OBJ_DOKU 169544 013 fm Seite 195 Mittwoch 17 M rz 2021 4 45 16...
Page 200: ...200 6 7 x 1 1 MM X CE OBJ_DOKU 169544 013 fm Seite 200 Mittwoch 17 M rz 2021 4 45 16...
Page 212: ...212 OBJ_DOKU 169544 013 fm Seite 212 Mittwoch 17 M rz 2021 4 45 16...
Page 218: ...218 4 5 5 1 2 bar 2 bar 95 138 OBJ_DOKU 169544 013 fm Seite 218 Mittwoch 17 M rz 2021 4 45 16...
Page 223: ...223 7 x CE 1 1 X CE OBJ_DOKU 169544 013 fm Seite 223 Mittwoch 17 M rz 2021 4 45 16...
Page 224: ...224 OBJ_DOKU 169544 013 fm Seite 224 Mittwoch 17 M rz 2021 4 45 16...
Page 235: ...OBJ_DOKU 169544 013 fm Seite 235 Mittwoch 17 M rz 2021 4 45 16...