Instructions for use
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INSTRUCTIONS FOR USE WASHER-DISINFECTOR ETD4 Program Package “GA Special 3”
WD00264A
Contents 1 General Information...5 1.1 User Instructions...5 1.2 Conventions throughout this Document...5 1.3 Manufacturer/Distributor...5 2 Introduction...6 2.1 Intended Use...6 2.2 User Levels...6 2.3 List of Parameters...6 3 Program Overview...7 3.1 STD10-PC-DR03...8 3.2 STD10-PC-DR15...8 3.3 STD20-PC-DR03...8 3.4 STD20-PC-DR15...9 3.5 STD05-PC-DR03...9 3.6 STDRD PRECL DRY...9 3.7 THERMAL DISIN...10 3.8 SELF DISIN...10
General Information
1 General Information 1.1 User Instructions The complete set of instructions for use for this product consists of the instructions for use for the respective program package (this document), the instructions for use for the washerdisinfector and the accessory sheet “Adapters for ETD3/ETD4 - Compatibilities”. •• Before use, thoroughly read these instructions for use, the instructions for use for the respective program package, the accessory sheet “Adapters for ETD3/ETD4 Compatibilities” and the instructions for use of the products that will be reprocessed in the washer-disinfector. •• If the required instructions for use are missing, immediately contact an Olympus representative. •• Keep the instructions for use in a safe, accessible location.
1.2 Conventions throughout this Document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. Capital letters are used to identify program names.
1.3 Manufacturer/Distributor Manufacturer Miele & Cie KG Carl-Miele-Straße 29 33332 Gütersloh Germany Distributor Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
5
Introduction
2 Introduction Before putting the equipment into operation, read the instructions for use carefully to prevent injury to the user and damage to the equipment.
2.1 Intended Use The program package is designed for use with the ETD4 GA washer-disinfectors.
2.2 User Levels Operating the programs of the washer-disinfector is subject to the user level listed below. User level A: To be used by the standard operator of the washer-disinfector. User level B: To be used only by the hospital technician. For more details user levels, refer to the instructions for use for the washer-disinfector.
2.3 List of Parameters Contact times The specified contact times do not have to be achieved without interruption. The contact time consists of the operating times that the machine works within the specified temperature range above the nominal temperature. Operating times below the nominal temperature do not count as contact time. The chapters 5.4.2 and 5.4.3 of EN ISO 15883 Part 4 state that the specified washing/ disinfection temperatures have to be kept in a range of -0 K to +5 K. Drying temperatures and times The drying temperatures can be measured at the air inlet directly after the drying unit by a low mass sensor. All sensors which are positioned at other places, such as instruments and chamber walls, will differ significantly from each other in temperatures and times. The sensors will be heated slowly and unequally due to the turbulent air flow in the washing chamber. The temperatures and times of these sensors will almost always be different than the times and temperatures indicated in the program listings.
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Program Overview
3 Program Overview The table below lists the programs in this program package. Programs listed for reprocessing flexible endoscopes may only be used for reprocessing flexible endoscopes. Programs listed for reprocessing rigid endoscopes may only be used for reprocessing rigid endoscopes. Details on selected programs are listed in the following sections. All material numbers listed in this document are Miele material numbers. Position on program selection switch
User level
Program name
Program approved for reprocessing endoscopes
Description
Material number
1
A
STD10-PC-DR03
flexible endoscopes
STANDARD disinfection program with intermediate rinsing and 10 min cleaning and 3 min drying
7925100
2
A
STD10-PC-DR15
flexible endoscopes
STANDARD disinfection program with intermediate rinsing and 10 min cleaning and 15 min drying
7925110
3
A
STD20-PC-DR03
flexible endoscopes
STANDARD disinfection program with intermediate rinsing and 20 min cleaning and 3 min drying
7925120
4
A
STD20-PC-DR15
flexible endoscopes
STANDARD disinfection program with intermediate rinsing and 20 min cleaning and 15 min drying
9342470
5
A
STD05-PC-DR03
flexible endoscopes
STANDARD disinfection program with intermediate rinsing and 5 min cleaning and 3 min drying
7925090
6
A
STDRD PRECL DRY
flexible endoscopes
STANDARD disinfection program with 2 min pre-rinse, intermediate rinsing and drying (15 min)
6104770
7
A
DRYING
–
Drying program (15 min)
5357040
8
A
THERMAL DISIN
rigid endoscopes
Thermal disinfection program
5357052
9
A
SELF DISIN
–
Self-disinfection program (thermal)
5357062
10
A
LEAK TEST
–
Separate leak test program with subsequent selfdisinfection. Do not start manually.
99999999 a
11
A
FLUSH
–
Washing chamber flush program with water
99999998
12
A
LT-LEAK TEST
–
Separate leak test program
99999953
13
A
DOSFILL CLEANER
–
Process for air removal from cleaner dosage system
99999997
14
A
DOSFILL DISIN
–
Process for air removal from disinfector dosage system
99999996
15
A
No function assigned
–
–
–
16
A
No function assigned
–
–
–
17
B
HYG-TEST-CL-RI
–
Validation program for cleaning performance
9476170
18
B
DOSFILL SYSTEM
–
Process for air removal from entire dosage system
7267320
19
B
SYSTEMCHECK
–
System check program. The program is a self-test program of the ETD4.
99999993
20
B
CHANGE UV-LAMP
–
Change UV lamp inside the UV unit. The program resets the hour counter for the UV lamp.
99999990
21
B
CHANGE FILTER1
–
Change coarse filter 1 inside the Drying Unit. The program resets the hour counter for the Air Filter 1
99999992
22
B
CHANGE FILTER2
–
Change air filter 2 inside the Drying Unit. The program resets the hour counter for the Air Filter 2.
99999991
23
B
TEACH-IN RT
–
Teach-in program for Flow Control. The program creates new reference values for an allowed selected endoscope type and overwrites any former values.
99999952
24
B
No function assigned
–
–
–
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Program Overview
3.1 STD10-PC-DR03 Material number: 7925100 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
10 min (±1 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±2.5 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
3 min (±2.5 %)
-
57 °C
-
3.2 STD10-PC-DR15 Material number: 7925110 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
10 min (±1 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±2.5 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
15 min (±1 %)
-
57 °C
-
3.3 STD20-PC-DR03 Material number: 7925120 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
20 min (±1 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±2.5 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
3 min (±1 %)
-
57 °C
-
8
Program Overview
3.4 STD20-PC-DR15 Material number: 9342470 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
20 min (±1 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±2.5 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
15 min (±1 %)
-
57 °C
-
3.5 STD05-PC-DR03 Material number: 7925090 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
5 min (±2.5 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±2.5 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
3 min (±1 %)
-
57 °C
-
3.6 STDRD PRECL DRY Material number: 6104770 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
-
-
-
-
Pre-cleaning
2 min (±2.5 %)
11 l (±5 %)
23 °C (-0 K/+5 K)
-
Cleaning
5 min (±2.5 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
0.5 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Disinfection
5 min (±2.5 %)
10.5 l (±5 %)
57 °C (-0 K/+5 K)
126 ml DETD (±10 %)
Second rinse
1.5 min (± 2.5 %)
10 l (±5 %)
No heating
-
Final rinse
3 min (±1 %)
9.5 l (±5 %)
57 °C (-0 K/+5 K)
-
Cool down
2 min
-
No heating
-
Drying
15 min (±1 %)
-
57 °C
-
9
Program Overview
3.7 THERMAL DISIN Material number: 5357052 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Pre-cleaning
1 min (±2.5 %)
10 l (±5 %)
No heating
-
Cleaning
5 min (±2.5 %)
10.5 l (±5 %)
53 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
2 min (±2.5 %)
9 l (±5 %)
No heating
-
Second rinse
1 min (±2.5 %)
9 l (±5 %)
No heating
-
Thermal disinfection
5 min (±2.5 %)
9.5 l (±5 %)
90 °C (-0 K/+5 K)
-
Cool down
5 min
-
No heating
-
Drying
15 min (±1 %)
-
90 °C
-
3.8 SELF DISIN Material number: 5357062 Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Cleaning
5 min (±2.5 %)
10.5 l (±5 %)
43 °C (-0 K/+5 K)
63 ml CETD (±10 %)
First rinse
1 min (±2.5 %)
10.5 l (±5 %)
No heating
-
Thermal disinfection
10 min (±1 %)
10.5 l (±5 %)
80 °C (-0 K/+5 K)
-
10
W7093150_2-0 2016-03-08 en
© Copyright 2016 Olympus Winter & Ibe GmbH