OLYMPUS
ETD Double Program package Instructions for Use
Instructions for Use
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INSTRUCTIONS FOR USE Washer-disinfector ETD Double Program package
Contents 1 General information...5 1.1 User instructions...5 1.2 Conventions...5 1.3 Manufacturer...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 FLEX standard...7 3.2 FLEX with heating final rinse...7 3.3 FLEX dry short...8 3.4 FLEX dry long...8 3.5 WD thermal self disinfection...8 3.6 MIS thermal disinfection...9 3.7 PERFORMANCE TEST cleaning...9 3.8 PERFORMANCE TEST disinfection...9 3.9 DEPOSIT short...9
General information
1 General information This product is under constant development. Even though all efforts are made to always update this instruction manual, we reserve the right to change technical data and equipment without previous announcement.
1.1 User instructions These instructions for use contain essential information on using this washer-disinfector safely and effectively. Before use, thoroughly review these instructions for use and the instructions for use of all equipment which will be used during the procedure and use the equipment as instructed The complete set of instructions for use for this product consists instructions for use for the standard user, for the advanced user, for the program overview (this document), and for the adapters. •• Before use, thoroughly read the instructions for use for the standard user, for the advanced user, for the program overview, for the adapters, and the instructions for use of the products that will be reprocessed in this 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 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.
1.3 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
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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 ETD Double washer-disinfector WD00104A.
2.2 User levels Operating the programs of the washer-disinfector is subject to the user level. For competences of the standard user and the advanced user, refer to the instructions for use for the standard user of 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 washer-disinfector 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. Program name
User level
Program approved for reprocessing endoscopes
Description
FLEX standard
Standard
flexible endoscopes
Standard disinfection program with intermediate rinsing
FLEX with heating final rinse
Standard
flexible endoscopes
Standard disinfection program with intermediate rinsing and heated final rinsing
FLEX dry short
Standard
flexible endoscopes
Standard disinfection program with intermediate rinsing and 15 min drying
FLEX dry long
Standard
flexible endoscopes
Standard disinfection program with intermediate rinsing and 90 min drying
WD thermal self disinfection
Standard
−
Self-disinfection program
MIS thermal disinfection
Standard
rigid instruments
Thermal disinfection program
PERORMANCE TEST cleaning
Advanced
flexible endoscopes
Validation program for cleaning performance
PERFORMANCE TEST disinfection
Advanced
flexible endoscopes
Validation program for disinfection performance
DEPOSIT short
Standard
−
Rinsing program for deposit removal
*This program is available on request. For more information, contact the service technician authorized by Olympus.
3.1 FLEX standard Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Pre-cleaning
0.5 min
14 l
No heating
−
Cleaning
3 min
18 l
35 °C (-0 K/+5 K)
6 ml/l detergent
First rinse
0.5 min
18 l
No heating
−
Disinfection
5 min
17 l
35 °C (-0 K/+5 K)
12 ml/l disinfectant, 12 ml/l activator
Second rinse
1 min
14 l*
No heating
−
Final rinse
1 min
14 l*
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.2 FLEX with heating final rinse Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Pre-cleaning
0.5 min
14 l
No heating
−
Cleaning
3 min
18 l
35°C (-0 K/+5 K)
6 ml/l detergent
First rinse
0.5 min
18 l
No heating
−
Disinfection
5 min
17 l
35 °C (-0 K/+5 K)
12 ml/l disinfectant, 12 ml/l activator
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Program overview Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Second rinse
1 min
14 l*
No heating
−
Final rinse
1 min
14 l*
55 °C (-0 K/+5 K)
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.3 FLEX dry short Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Pre-cleaning
0.5 min
14 l
No heating
−
Cleaning
3 min
18 l
35 °C (-0 K/+5 K)
6 ml/l detergent
First rinse
0.5 min
18 l
No heating
−
Disinfection
5 min
17 l
35 °C (-0 K/+5 K)
12 ml/l disinfectant, 12 ml/l activator
Second rinse
1 min
14 l*
No heating
−
Final rinse
1 min
14 l*
55 °C (-0 K/+5 K)
−
Drying
15 min
−
58 °C
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.4 FLEX dry long Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Pre-cleaning
0.5 min
14 l
No heating
−
Cleaning
3 min
18 l
35 °C (-0 K/+5 K)
6 ml/l detergent
First rinse
0.5 min
18 l
No heating
−
Disinfection
5 min
17 l
35 °C (-0 K/+5 K)
12 ml/l disinfectant, 12 ml/l activator
Second rinse
1 min
14 l*
No heating
−
Final rinse
1 min
14 l*
55 °C (-0 K/+5 K)
−
Drying
90 min
−
58 °C
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.5 WD thermal self disinfection Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Rinse
0.5 min
14 l*
No heating
−
Thermal disinfection
1 min
14 l*
90 °C (-0 K/+5 K)
−
Cool down
3 min
−
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
8
Program overview
3.6 MIS thermal disinfection Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Pre-cleaning
3 min
16 l
No heating
−
Cleaning
10 min
18 l
52 °C (-0 K/+5 K)
6 ml/l detergent
First rinse
2 min
18 l
No heating
−
Second rinse
1 min
15 l*
No heating
−
Thermal disinfection
5 min
15 l*
90 °C (-0 K/+5 K)
−
Drying
30 min
−
90 °C
−
Cool down
5 min
−
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.7 PERFORMANCE TEST cleaning Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Pre-cleaning
0.5 min
14 l
No heating
−
Cleaning
3 min
18 l*
35 °C (-0 K/+5 K)
6 ml/l detergent
First rinse
0.5 min
18 l*
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.8 PERFORMANCE TEST disinfection Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
Leakage test
−
−
−
−
Disinfection
5 min
17 l
35 °C (-0 K/+5 K)
12 ml/l disinfectant, 12 ml/l activator
Second rinse
1 min
14 l*
No heating
−
Final rinse
1 min
14 l*
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
3.9 DEPOSIT short Program step
Contact time
Water inlet quantity
Temperature
Chemical dosage quantity
First rinse
0.5 min
17 l*
No heating
−
Second rinse
1 min
17 l*
No heating
−
*In this process step, 0.22 ml of disinfectant per liter water (= 10 ppm PAA) is dosed into the incoming water. This quantity of PAA is harmless to patients and users.
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W7092200_04 2016-07-19 en
© Copyright 2016 Olympus Winter & Ibe GmbH