Type WD440PT Model 302-XXX User Manual Ver 5.1 Sept 2014

USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 2 OF 92

USER MANUAL WASSENBURG® WD440 PT WASHER-DISINFECTOR FOR FLEXIBLE ENDOSCOPES AND OTHER THERMOLABILE MEDICAL DEVICES

Machine Information Type: WD440 PT Model: Series: 302-XXX 0344 Document Information User manual Version: 5.1 Language: English Date of issue: September, 2014 Ref.: AMRF0601GB51 Manufacturer Information Wassenburg Medical B.V. Edisonring 9 6669 NA DODEWAARD THE NETHERLANDS

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This manual is printed on paper from responsible sources.

© Copyright 2014 No part of this documentation may be reproduced and / or published in any form or by any means, printing, photocopying, microfilm or otherwise, without prior written permission of the publisher. All information is subject to change. Figures and photos may differ from the actual situation.

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TABLE OF CONTENTS CHAPTER 1 – SPECIFICATIONS ___________________________________ 9 1.1

Introduction _____________________________________________ 9

1.2

Intended use ____________________________________________ 9

1.3

Compliance ____________________________________________ 10

1.4

Components ___________________________________________ 10

1.5

Requirements __________________________________________ 15

1.5.1 15

Requirements for endoscopes and other thermolabile medical devices

1.5.2

Requirements for peripheral equipment ______________________ 15

1.5.3

Installation requirements __________________________________ 15

1.6

Process conditions ______________________________________ 15

CHAPTER 2 – SAFETY __________________________________________ 17 2.1

Safety symbols _________________________________________ 17

2.2.

Safety aspects _________________________________________ 18

CHAPTER 3 – QUICK START _____________________________________ 21 CHAPTER 4 – HOW TO USE _____________________________________ 23 4.1

Programs _____________________________________________ 23

4.2

Switching on the WD440 PT _______________________________ 24

4.3

Starting a program ______________________________________ 25

4.3.1

Preliminary actions prior to reprocessing the endoscope _________ 26

4.3.2

Open the lid ____________________________________________ 27

4.3.3

Load the endoscope _____________________________________ 27

4.3.4

Connect the endoscope __________________________________ 28

4.3.5

Start the washing and disinfection program ___________________ 31

4.3.6

During the program ______________________________________ 36

4.4

Unloading the endoscope _________________________________ 40

4.5

Drying and storage of the endoscope ________________________ 41

4.6

Additional actions _______________________________________ 41

4.6.1

Process identification and registration _______________________ 41 USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 5 OF 92

4.6.2

Printer ________________________________________________ 45

4.6.3

Replacing detergent and disinfectant ________________________ 48

4.6.4

Refill alcohol ___________________________________________ 52

4.6.5

Help functions __________________________________________ 53

CHAPTER 5 – BASIC MAINTENANCE ______________________________ 57 5.1

Daily maintenance_______________________________________ 57

5.2

After the last program of the day____________________________ 59

5.3

Replacing the bacterial filters ______________________________ 59

5.3.1

Removing the bacterial filter _______________________________ 62

5.3.2

Disinfection or sterilization of the bacterial filter ________________ 62

5.3.3

Placing the bacterial filter _________________________________ 63

5.3.4

Bleeding the bacterial filter ________________________________ 64

5.3.5

Resetting the filter cycle counter ____________________________ 65

5.4

Self-disinfection _________________________________________ 66

5.4.1

Thermal self-disinfection __________________________________ 69

5.4.2

Chemical self-disinfection _________________________________ 72

CHAPTER 6 – BASIC EVENTS ____________________________________ 73 6.1

Introduction ____________________________________________ 73

6.2

Alarms ________________________________________________ 75

6.2.1

AL01 / AR01: Abort program and close lid ____________________ 77

6.2.2

AL02-AL07 / AR02-AR07: Channel X pressure too high _________ 77

6.2.3

AL09 / AR09: Detergent container empty _____________________ 79

6.2.4

AL10-AL15 / AR10-AR15: Disconnection channel X ____________ 79

6.2.5

AL17 / AR17: Disinfectant container empty ___________________ 80

6.2.6

AL18 / AR18: Dosing fault _________________________________ 80

6.2.7

AL20 / AR20: Drainage fault _______________________________ 80

6.2.8

AL21 / AR21: Endoscope leaks ____________________________ 81

6.2.9

AL22 / AR22: Endoscope leaks, program aborted ______________ 81

6.2.10

AL26 / AR26: Leakage drip tray full _________________________ 81

6.2.11

AL28 / AR28: Level switch faulty ___________________________ 82

6.2.12

AL33 / AR33: No circulation pressure ________________________ 82

6.2.13

AL34-AL39 / AR34-AR39: No supply channel X ________________ 83

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6.2.14

AL40 / AR40: No supply channel 7 __________________________ 83

6.2.15

AL41 / AR41: No water supply _____________________________ 83

6.2.16

AL42 / AR42: Pressure drop too great _______________________ 83

6.2.17

AL43 / AR43: Leakage test pressure too high _________________ 84

6.2.18

AL44 / AR44: Pressure not reached _________________________ 84

6.2.19

AL46 / AR46: Program manually interrupted __________________ 84

6.2.20

AL48 / AR48: System fault ________________________________ 85

6.2.21

AL49 / AR49: Temperature too high _________________________ 85

6.2.22

AL50 / AR50: Temperature too low _________________________ 85

6.2.23

AG01: Leakage drip tray full (machine standby) _______________ 85

6.2.24

AL29 / AR29 Alcohol container empty _______________________ 85

6.3

Warnings ______________________________________________ 86

6.3.1

WG01: Detergent container nearly empty ____________________ 86

6.3.2

WG02: Exhaust fan faulty _________________________________ 87

6.3.3

WG06: No heartbeat signal from server. IDs are checked locally. __ 87

6.3.4

WG10: Server is not responding to request ___________________ 87

6.3.5

WG81: Alcohol container nearly empty ______________________ 87

6.3.6

WL01 / WR01: Channel flow relay failed _____________________ 87

6.4

IMS faults _____________________________________________ 88

APPENDIX 1 – CHECKLIST FOR REPLACING CHEMICALS ____________ 91

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CHAPTER 1 – SPECIFICATIONS THIS CHAPTER CONTAINS AN INTRODUCTION AND SPECIFICATIONS ON THE WD440 PT (PASS THROUGH) ENDOSCOPE WASHER DISINFECTOR.

1.1

Introduction

®

Thank you for using the first class WASSENBURG equipment. This user manual accompanies the WD440 PT (Pass Through) endoscope washer disinfector. This manual describes the operation and working of the WD440 PT machine and is intended for users who operate and qualified service engineers who service the WD440 PT. Users are those who operate the WD440 PT in the course of their work within the framework of a professional healthcare activity and who have been trained to operate the WD440 PT. Qualified service engineers are employed by recognised Wassenburg service departments or service partners, have been trained by Wassenburg and are authorised by Wassenburg to service the WD440 PT. Also available are a service manual and a support manual. The equipment may only be serviced or validated by qualified engineers. If Wassenburg is contacted for support, the machine serial number will be requested. This number can be found on the type plate in the lower section of the machine. Your authorised supplier can inform you on the approved service and validation partners. Always read the manual before use! Operator instructions will be given by the authorised supplier following installation of the system. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired and all guarantees provided by the manufacturer are put at risk. Only correct use of the machine will ensure safe and effective operation of the machine according to the applicable standards. Please refer to the website www.wassenburgmedical.com for more information on the Wassenburg international distribution network.

1.2

Intended use

The WD440 PT is intended for washing and disinfection of flexible endoscopes and other re-usable thermolabile medical devices in the health care sector. The machine is not suitable for domestic purposes. USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 9 OF 92

1.3

Compliance

The WD440 PT fulfils the requirements of the European Medical Device Directive (93/42/EEC) and meets the applicable parts of the ISO 15883 standards for washer disinfectors:  Part 1: General requirements, terms and definitions and tests;  Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes.

1.4

Components

The WD440 PT washer disinfector is composed of two independently-operated sections: left and right. Furthermore, the machine has a load side (endoscopes to be reprocessed) and an unload side (successfully reprocessed endoscopes). Both sections can be operated at the load and unload sides using the touch screen displays, ‘close’ buttons and foot switches. Operating the unload side is only possible if the process has resulted in a completely reprocessed endoscope. Components load side WD440 PT, see illustration 1.1. I. Upper panel The upper panel contains the touch screen operating display. II. Touch screen display III. Locks from cover plate on upper panel of load side The upper technical compartment is only accessible for qualified service engineers. IV. Screen Metal screen which separates the load side from the unload side. V. Lid with sprinkler The lid of the chamber contains a seal and is fitted with a sprinkler. The sprinkler rotates during the program for reprocessing the outside of the endoscope, the chamber and the lid. VI. Validation port / Sample port (optional) The validation port, designed according to the ISO 15883 standard, can be used for validation purposes. This validation port can be replaced by the optional sample port. The sample port is designed for sampling final rinse water. Details on sampling are described in the support manual. VII. Chamber The endoscope to be reprocessed is loaded into the chamber. This chamber contains connectors for connecting the channels of the endoscope. VIII. Top section The top section contains two chambers and the ‘close’ buttons. IX. Close button (present on both sides) X. LED indication bar XI. Connection bar code reader XII. Door fastening (push right door to open) USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 10 OF 92

XIII.

XIV.

Lower section The lower section houses the detergent, disinfectant, bacterial filters and the main switch on the load side (not shown). The lower section is closed by two doors (push right door to open). Foot switch (separate for each chamber)

ILLUSTRATION 1.1 | Load side WD440 PT USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 11 OF 92

Components unload side WD440 PT, see illustration 1.2. I. II. III.

IV. V.

VI.

VII. VIII. IX. X.

XI.

XII.

Upper panel The upper panel contains the touch screen operating display. Touch screen display Locks for left and right cover plates on upper panel of unload side The upper technical compartment is only accessible for qualified service engineers. Screen Metal screen which separates the unload from the load side. Lid The lid of the chamber contains a seal and is fitted with a sprinkler. The sprinkler rotates during the program for reprocessing the outside of the endoscope, the chamber and the lid. Top section The top section contains two chambers and the ‘close lid’ buttons. The correctly reprocessed endoscope can be unloaded from the chamber. Close lid button (present on both sides) LED indication bar Connection bar code reader Printer compartment As well as the integral printer, the printer compartment contains the locks for the lower section and the main switch for the unload side. Refer to illustration 1.3 for a detailed description. Lower section The lower section houses the electronic equipment box, which is not accessible by the user. Foot switch (separate for each chamber)

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I.

II. III.

IV.

V. VI. VII. VIII. IX. X.

XI.

XII. ILLUSTRATION 1.2 | Unload side WD440 PT USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 13 OF 92

I. II. III. IV

ILLUSTRATION 1.3 | Printer compartment WD440 PT

I.

II.

III.

IV.

Fastening printer compartment. The printer compartment can be opened by pushing the printer compartment door. Main switch unload side The main switch on the unload side is located behind the printer cover plate. Locks for lower section The lower section can be locked so that only qualified service personnel has access to the electronical equipment box. The locks are located behind the printer cover plate. Integral printer The printer prints process data directly from the machine.

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1.5

Requirements

The correct performance of the WD440 PT can only be guaranteed if the following requirements are met:  Only use by professional users, which means users must be trained and use the device in the course of their work and in the framework of a professional healthcare activity;  All instructions for correct use and maintenance must be followed;  Always use original Wassenburg parts and approved filters, detergents and disinfectants;  Additional local requirements may be applicable, your authorised supplier can provide further information. 1.5.1 Requirements for endoscopes and other thermolabile medical devices Endoscopes and other thermolabile medical devices must be released by Wassenburg for reprocessing in the WD440 PT. All released medical devices ® are included in the WASSENBURG database. Your authorised WD440 PT supplier can verify if a particular endoscope or other thermolabile medical device has been released for reprocessing in the WD440 PT. Please contact the authorised WD440 PT supplier for more information. 1.5.2 Requirements for peripheral equipment Equipment connected to the WD440 PT, such as water treatment systems or computers, must fulfil the relevant connection compatibility requirements. Please contact the authorised WD440 PT supplier for more information. 1.5.3 Installation requirements The machine and the installation must fulfil the specifications as determined by Wassenburg and the machine must be installed in accordance with the installation procedure of Wassenburg.

1.6

Process conditions

Endoscopes and other thermolabile medical devices which are reprocessed in the WD440 PT must minimally be able to withstand the following conditions:  Temperatures from +10ºC to +60ºC;  Pressure of up to 1.5 bar for medical device channels;  Pressure during the leakage test of 300 mbar;  The detergents, disinfectants and alcohol (optional) used;  Availability of connectors for each medical device channel;  Waterproof, immersible and, if applicable, provided with parts which protect the medical device against moisture damage. Process conditions also depend on combination of used detergent, disinfectant and alcohol (optional).

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CHAPTER 2 – SAFETY FOLLOW THE SAFETY REGULATIONS FOR YOUR OWN SAFETY AND THE SAFETY OF THE PATIENT.

2.1

Safety symbols

Symbols are present on the WD440 PT which indicate possible hazards. CAUTION Locations:

- Detergent suction tube; - Lower rim of the bottom plate; - In this user manual to draw attention to possible risks.

HAZARDOUS ELECTRIC POTENTIAL Locations: - Screening plate of the electric equipment box (E-box) at the unload side of the machine; - Electrical entry assembly box in the upper section. MOVING PARTS Location: - Chamber lids.

HOT SURFACE Locations: - Heating element holders; - Pre-filter housing in the front section. CORROSIVE SUBSTANCES Locations: - Supply tubing from the disinfectant container; - Measuring cylinder; - Lower rim of the bottom plate. FLAMMABLE Locations: - Alcohol container (optional); - On the inside of the right door. CONSULT INSTRUCTIONS FOR USE Indicates the need for the user to consult the instructions for use.

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NOTE! Location:

2.2.

- In this user manual to draw attention to important points.

Safety aspects

Hygienic measures  Endoscopes should be reprocessed immediately following patient treatment;  The machine and endoscopes can become contaminated. Always follow the protocol for the handling of contaminated instruments and the infection prevention protocol from your hospital;  Endoscopes must be pre-cleaned directly after patient treatment and prior to reprocessing in the WD440 PT. Follow the requirements for manual cleaning of the endoscope provided by the endoscope manufacturer. The endoscope and other thermolabile medical devices  Prior to reprocessing a new type of endoscope or other thermolabile medical device, the connection procedure must be established and released by Wassenburg for reprocessing in the WD440 PT. All released medical devices ® are included in the WASSENBURG database. Contact your authorised WD440 PT supplier for more information;  Check the endoscope or other thermolabile medical device before and during pre-cleaning for damage. A damaged endoscope or other thermolabile medical device should be repaired before reprocessing in the WD440 PT. Consult the instructions of the medical device supplier and the protocol of your hospital. Operating the machine  The WD440 PT may only be operated by one person at a time, at the load or unload side. An exception is made for loading a large ultrasound endoscope, during which it may be necessary for a colleague to assist by holding the extra connector;  The lid must always be closed using the the two-handed control;  Users must have received proper training and have read the instructions for use;  Always leave the main switch of the WD440 PT on when detergent or disinfectant containers are present in the machine so that potential hazardous vapours can be extracted;  Ensure that appropriate ventilation requirements are being achieved;  Never place objects on any part of the machine;  The rims of the lid and the chamber must be kept free from obstruction;  Carrying out modifications to the washing and disinfection system without the approval of Wassenburg is not permitted. All warranties expire upon unauthorized modifications. USER MANUAL WD440 PT | REF. AMRF0601GB51 | PAGE 18 OF 92

During reprocessing  In the event of a channel pressure fault (for example a blockage), it is possible that the channel is still under pressure and liquid may spray from the endoscope after disconnection. Take appropriate safety precautions following the infection prevention protocol;  If a program is interrupted or aborted, the endoscope and the inside of the machine may still be contaminated;  If a program is aborted due to a power failure, the program must be repeated. Please refer to the protocol in the service manual;  During the thermal self-disinfection program the temperature of the lids of the machine can increase. Do not touch the lids during thermal self-disinfection. Handling detergent, disinfectant and alcohol  Detergents and disinfectants may be irritant. Follow the safety precautions as directed in the (Material) Safety Data Sheets (MSDS / SDS) of the used detergent and disinfectant;  Wassenburg advises using suitable protective garments for the detergent, disinfectant and alcohol concerned, such as gloves, safety goggles, apron, half-mask respirator and footwear;  Always make sure that the approved and set detergent and disinfectant are used. The set product combination (DIS) can be found by pressing the button in the bottom left corner on the display;  Ensure that disinfectant and detergent containers are correctly located in the WD440 PT. Switching the containers can have serious effects on the performance of the endoscope reprocessing process;  Check periodically the expiration date of the detergent and disinfectant in use. Do not use chemicals which have exceeded their expiration date.

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