ETD Mini Instructions for Use

Contents 1 Using this document...5 1.1 User instructions...5 1.2 Conventions throughout this document...5 1.3 Safety-related information in this document...5 2 Safety information...7 2.1 Intended purpose...7 2.2 Contact...7 2.3 General safety notes...8 3 Product description...11 3.1 Scope of delivery...11 3.2 Versions...12 3.3 Optional components...12 3.4 General description...13 3.5 Product overview...14 3.6 Washing chamber...18 3.7 Baskets...19 3.8 Adapters for thermal self-disinfection...23 3.9 Accessoires and tools...24 3.10 Storage compartment...25 3.11 Control elements...28 3.12 Features...31 3.13 Symbols...32 3.14 Warranty...34 4 Overview of endoscope reprocessing...35 5 Before use...36 6 Use...37 6.1 Safety notes for use...37 6.2 Endoscope preparation...38 6.3 Endoscope positioning...38 6.4 Endoscope and endoscope washer-disinfector connection...46 6.5 Reprocessing of probes without lumen and leakage tester...50 6.6 Endoscope valves insertion...51 6.7 Basket insertion...53 6.8 Switching on the endoscope washer-disinfector...53 6.9 Reprocessing process...54 6.10 Manual door opening...58 7 After use...59 8 Machine settings...60 8.1 Language...60 8.2 Volume buzzer...60 8.3 Time and date...60 8.4 Reprocessing protocols...61 9 Database Management...62 9.1 User Management...62

9.2 Endoscope Management...62 10 Maintenance...63 10.1 Cleaning and disinfection the outer surface...63 10.2 Cleaning the sieves...64 10.3 Performing thermal self-disinfection...66 10.4 Cleaning the spray arm nozzles...69 10.5 Checking, cleaning and disinfection the door sealings...71 10.6 Checking the O-rings in the washing chamber...71 10.7 Checking the self-disinfection adapter and the yellow tubing ...72 10.8 Replacing the water inlet filters...73 10.9 Maintenance request...76 10.10 Replacing process chemical containers...76 10.11 Exchanging printing paper...85 10.12 Cleaning the washing chamber from persintent residues...86 10.13 Performing process validation...86 10.14 Performing hygienic inspections of the final rinse water...86 10.15 Longer periods of inactivity...87 11 Repair, service and disposal...88 11.1 Repair...88 11.2 Service...88 11.3 Disposal...88 12 Troubleshooting...90 12.1 Note messages...90 12.2 Error message...91 12.3 Power failure...94 13 Ordering information...96 13.1 Process chemicals...96 13.2 Consumables...96 13.3 Endoscopes...96 13.4 Valves...97 13.5 Baskets...97 13.6 Endoscope adapters...97 13.7 Leakage test adapters...98 13.8 Documentation systems...98 13.9 Optional components...98 14 Compatible equipment...99 15 Technical data...101 15.1 Endoscope washer-disinfector...101 15.2 Ambient conditions...102 15.3 Process chemicals...102 16 Electromagnetic compatibility...105 17 Glossary...108 18 Index...110 19 Check list for daily routine checks...113

Using this document

1 Using this document This chapter provides a general information on how to use these instructions for use.

1.1 User instructions Before use, thoroughly read these instructions for use and the instructions for use of all other products that will be used during the procedure. 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. This symbol indicates additional helpful information. 1. A numeration indicates a sequence of actions. 2. 3. ► An arrow indicates a result of an action. • Bullet points indicate individual actions. - Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations. 2) 3) […] Bracketed terms refer to elements in the graphical user interface or keys. Elements in the graphical user interface can be: - buttons - menu items - dialog elements A user is a person responsible for reprocessing endoscopes.

1.3 Safety-related information in this document For safe and efficient use of this product it is important to read the complete instructions for use. The safety related information of these instructions for use is not only described in this chapter. All information and instructions in this document are to ensure a safe and efficient use. Safety information are described in 3 categories: ‒ General safety notes ‒ Specific safety notes ‒ Safety messages

5

Using this document

1.3.1 General safety notes General safety notes are located at the beginning of the instructions for use. They address safety issues that apply to the general use and handling of the product. 1.3.2 Specific safety notes Specific safety notes are located at the beginning of a chapter or section. They address safety issues that are specific to the information and actions described in the chapter or section. 1.3.3 Safety messages Safety messages focus on unexpected incidents that can occur during the intended use. They are placed in the context of such risks and actions. The safety messages are highlighted by a signal word. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

6

Safety information

2 Safety information This chapter provides general safety information for using the product. The safety information includes: ‒ Intended purpose ‒ Manufacturer information ‒ General safety notes

2.1 Intended purpose 2.1.1 Intended use and indications Device for washing and high level disinfection of flexible endoscopes. 2.1.2 User qualification Qualified personnel who have the relevant expert knowledge of reprocessing flexible endoscopes and who have been trained by instructed Olympus representative to reprocess flexible endoscopes in the endoscope washer-disinfector. 2.1.3 Contraindications There are no known contraindications. 2.1.4 Patient target group Not dedicated to any patient population. 2.1.5 Clinical benefits The system allows a safe reprocessing of flexible endoscopes.

2.2 Contact 2.2.1 Manufacturer Steelco S.p.A Via Balegante, 27 330139 Riese Pio X (TV) Italy 2.2.2 Distributer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

7

Safety information

2.2.3 CH-REP Steelco AG Limmatstrasse 4 08957 Spreitenbach Switzerland Country-specific information Refer to the contact information for customers included in the scope of delivery for countryspecific information. 2.2.4 Incident reporting European Union If a serious incident occurs with the device, report it to the distributor and the relevant national authority. Eurasian Economic Union If an undesirable event occurs with the device, report it to the distributor or the authorized representative. Other regions If a serious incident occurs with the device, report it to the distributor and/or the relevant national authority according to national legislation.

2.3 General safety notes The following safety information address points that apply to the general handling and use of the product. This information is to be supplemented by the information given in each chapter of this document. WARNING Risk of injury to the user Any use other than the one intended is forbidden. Improper use of this unit can be hazardous to the user and can seriously damage the endoscope washer-disinfector itself. Do not use the endoscope washer-disinfector for any other purposes than the one intended. Read all instructions for use thoroughly Before use, read this instructions for use and the instructions for use for all other equipment which will be used during the procedure. An insufficient understanding of the safety information in these instructions for use can result in death, serious injury, or equipment damage. The complete set of instructions for use for this product consists of the following documents: ‒ Instructions for use for the ETD Mini endoscope washer-disinfector (this document) ‒ Instructions for use for the program packages ‒ Instructions for use for Olympus Adapter ‒ Instructions for use for Pentax Adapter ‒ Instructions for use for Fujifilm Adapter ‒ Instructions for use for Karl Storz Adapter ‒ Instructions for use for Richard Wolf Adapter

8

Safety information

‒ ‒ ‒ ‒ ‒

ETD Mini – Compatible adapters and RFID tags for Olympus endoscopes ETD Mini – Compatible adapters and RFID tags for Pentax endoscopes ETD Mini – Compatible adapters and RFID tags for Fujifilm endoscopes ETD Mini – Compatible adapters and RFID tags for Karl Storz endoscopes ETD Mini – Compatible adapters and RFID tags for Richard Wolf endoscopes

In addition, the instructions for use of the products to be reprocessed are needed for the reprocessing procedure. For questions on the topics covered in these instructions for use or on the operation or safety of the equipment, contact an Olympus representative. Repair and product modifications Unauthorized repairs and product modification can cause injury to the patient and the user. Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus. Refer to section “11.1 Repair“ on page 88 for more details. Incompatible equipment Reprocessing incompatible equipment of the endoscopes or incompatible endoscopes in the washer‑disinfector can cause inefficient reprocessing and infection of the patient. Use and reprocess only compatible equipment in the washer‑disinfector. For information on compatible equipment, refer to the compatibility lists. 2.3.1 User protection Personal protective equipment Patient debris and reprocessing chemicals are hazardous. If these substances come into contact with exposed skin, they can cause infections or irritate the skin. Personal protective equipment can reduce these hazards. To protect against hazardous chemicals and infectious material when operating with the endoscope washer-disinfector (e.g. exchanging chemical containers, performing any maintenance or troubleshooting or handling contaminated endoscopes), wear personal protective equipment like: ‒ Eye wear ‒ Face mask ‒ Moisture-resistant clothing ‒ Chemical-resistant gloves. Gloves must fit properly so that no skin is exposed. 2.3.2 High temperatures Burning of the skin Contact with the hot device or equipment can cause burning of the skin. Do not touch the outside or inside of the endoscope washer-disinfector during a thermal self-disinfection or immediately after. Let the washing chamber and the equipment cool down before touching or removing. 2.3.3 Power and water supply Water damage The safety and diagnosis system will be deactivated if the endoscope washer-disinfector is left unused or is disconnected from the electrical connection. Always turn off the water taps when the endoscope washer-disinfector is not used.

9

Safety information

2.3.4 Detergents and disinfectants Incompatible detergents and disinfectants Cleaning and disinfection avoid infections of patients and the medical personnel. Refer to the cleaning and the disinfection instructions for detergent and disinfectant information. Use only original compatible detergents and disinfectants to prevent damage to the endoscope. Refer to chapter “13 Ordering information“ on page 96. Residues of detergents and disinfectants Detergents and disinfectants can contain aggressive compounds. If residues of the compounds are left on the endoscope after cleaning or disinfection, the residues can damage the endoscope. 2.3.5 Reprocessing chemicals Chemical burning of the skin Contact with chemicals during handling reprocessing chemicals can cause chemical burning of the skin. Avoid contact by using appropriate personal protective equipment (e. g. lab coat, protective gloves, safety glasses, mask) and act in compliance with the safety recommendations indicated by the manufacturer of the chemical products. Immediately take off clothing which has been contaminated or soaked by chemicals. If these chemical products come into contact with the skin, wash off affected skin areas immediately and rinse with plenty of water. Contact of chemicals with the eyes Chemical products are an irritant for the eyes. Avoid contact by using appropriate personal protective equipment (e. g. lab coat, protective gloves, safety glasses, mask) and act in compliance with the safety recommendations indicated by the manufacturer of the chemical products. If these chemical products come into contact with the eyes, rinse with plenty of water and consult a doctor. Vapours of process chemicals Process chemicals escaping from the endoscope washer-disinfector or the container will result in vapours which can cause damage to the respiratory tract. Use appropriate personal protective equipment (e. g. lab coat, protective gloves, safety glasses, mask). Act in compliance with the safety recommendations indicated by the manufacturer of the chemical products and if there are none, wear a mask for the protection of the respiratory airways. Make sure that the air ventilation is sufficient. Make sure that all advice for safe handling of the process chemicals is observed. Refer to the Material Safety Data Sheets. Chemicals of other manufacturers Using chemicals which are not recommended by Olympus can cause infection of the patient and damage to the endoscope washer-disinfector. Only use chemicals recommended by Olympus for the reprocessing. If other chemicals are used, Olympus cannot make any statement about the effectiveness of the reprocessing and about the material compatibility.

10

Product description

3 Product description This chapter provides a general overview of the product and its functions. This includes the following information: ‒ Scope of delivery ‒ Product description and functions ‒ Control elements ‒ Explanation of symbols ‒ Warranty information

3.1 Scope of delivery Before use, check that all items listed below are available. Contact an Olympus representative or an authorized service center if any items are missing or damaged. 3.1.1 ETD Mini, 1 chamber, PAA (WD00500A) or GA (WD00501A) Endoscope washer-disinfector ‒ Endoscope washer-disinfector with 1 washing chamber ‒ Installation accessories ‒ 2 water inlet filters (0.45 µm and 0.1 µm) ‒ Printer paper (4 rolls) ‒ O-ring spare parts Basket ‒ Standard basket C587 (WD00504A), including: ‒ Basket brackets ‒ Valve holder Adapter accessories ‒ Self-disinfection adapter and yellow tubing for self-disinfection ‒ Leakage test plug Tools ‒ Emergency release tool ‒ Tool for dismounting the closure plugs of the spray arms Instructions for use ‒ Instructions for use for the endoscope washer-disinfector (this document) ‒ Instructions for use for the program packages ‒ Instructions for use for Olympus, Pentax, Fujifilm, Storz and Wolf adapters ‒ Compatibility lists of Olympus, Pentax, Fujifilm, Storz and Wolf endoscopes 3.1.2 ETD Mini, 2 chambers, PAA (WD00502A) or GA (WD00503A) Endoscope washer-disinfector ‒ Endoscope washer-disinfector with 2 washing chambers ‒ Installation accessories ‒ 4 water inlet filters (2 x 0.45 µm and 2 x 0.1 µm) ‒ Printer paper (8 rolls) ‒ O-ring spare parts

11

Product description

Baskets ‒ 2 Standard basket C587 (WD00504A), including each: ‒ 1 bracket kit ‒ 2 valve holders Adapter accessories ‒ 2 self-disinfection adapters and 2 yellow tubings for self-disinfection ‒ 2 leakage test plugs Tools ‒ Emergency release tool ‒ Tool for dismounting the closure plugs of the spray arms Instructions for use ‒ Instructions for use for the endoscope washer-disinfector (this document) ‒ Instructions for use for the program packages ‒ Instructions for use for Olympus, Pentax, Fujifilm, Storz and Wolf adapters ‒ Compatibility lists of Olympus, Pentax, Fujifilm, Storz and Wolf endoscopes

3.2 Versions Endoscope washer-disinfector

Article number

Reprocessing chemicals

Number of washing chambers

ETD Mini, 1 chamber, PAA

WD00500A

Peracetic acid

1

ETD Mini, 1 chamber, GA

WD00501A

Glutaraldehyde

1

ETD Mini, 2 chambers, PAA

WD00502A

Peracetic acid

2

ETD Mini, 2 chambers, GA

WD00503A

Glutaraldehyde

2

3.3 Optional components The following components are not included in the standard scope of delivery of the endoscope washer-disinfector. Basket C588 WD00505A ‒ Basket for 2 endoscopes ‒ Reference sheet to instructions for use Basket C589 WD00506A ‒ Basket without endoscope holders ‒ Reference sheet to instructions for use Castors WD00507A ‒ Castors ‒ Reference sheet to instructions for use Software license “Hytrack” For further information on “Hytrack”, contact an Olympus representative. WD10800A Reprocessing interface, department license

12

Product description

WD10801A Documentation license, workstation license WD10802A Advanced reprocessing license, workstation license ‒ Reprocessing documentation software ‒ Instructions for use

3.4 General description The ETD Mini is an endoscope washer-disinfector that allows reprocessing of up to 2 flexible endoscopes at the same time in a chemo-thermal disinfection process. All processes are compliant to the relevant parts of EN ISO 15883-1, -4, -5. The endoscope washer-disinfector has been designed to be used in a reprocessing area of endoscopy departments or in the central sterilization service department. A safe reprocessing can only be ensured when using process chemicals which have been applied in the framework of type testing of ETD Mini according to EN ISO 15883-1 and EN ISO 15883-4. For the ETD Mini the term “endoscope washer-disinfector”, “washer-disinfector” and “endoscope washer” are used as equivalent terms.

13

Product description

3.5 Product overview ETD Mini, 1-chamber Front side

1) 2) 3) 4) 5)

14

Emergency door opening Washing chamber handle Display Control panel Printer

Product description

6) 7) 8) 9)

Power button USB port Storage compartment Base with lockable castors (optional)

ETD Mini, 1-chamber Back side

1) Exhaust 2) Coarse filter (0.45 µm) 3) Fine filter (0.1 µm)

15

Product description

ETD Mini, 2-chamber Front side

1) Emergency door opening

16

Product description

2) 3) 4) 5) 6) 7) 8)

Washing chamber handle Display Control panel Printer Power button USB port Storage compartment

ETD Mini, 2-chamber Back side

17

Product description

1) Exhaust 2) Coarse filter (0.45 µm) 3) Fine filter (0.1 µm)

3.6 Washing chamber Left and lower section

1) 2) 3) 4) 5) 6)

18

Door sealing Basket coupling Fluid temperature sensor Inlet for process chemicals Lower spray arm Heating element

Product description

Right and upper section

7) Upper spray arm 8) Leakage test port 9) Self-disinfection adapter port 10) Air temperature sensors 11) Outlet for exhaust 12) Water inlet

3.7 Baskets The baskets for the flexible endoscopes are made of stainless steel grid. For reprocessing of flexible endoscopes, there are different baskets available. Each basket has a fluid distribution pipe for the endoscope adapters on its left side. There are 7 adapter connection positions in the basket in total.

19

Product description

Standard basket C587 (WD00504A)

1) 2) 3) 4) 5) 6) 7) ►

Basket handle Basket brackets Holder for the control section of the endoscope Position to place the valve holder Guiding elements for the insertion tube of the endoscope Holder for the light guide of the endoscope Fluid distribution pipe with 7 adapter connection positions 1 connection position is located at the yellow tube.

The standard basket C587 is delivered with the endoscope washer-disinfector. The standard basket is designed for reprocessing 1 endoscope and provides a holder for the light guide and a holder for the control section of the endoscope.

20

Product description

Basket C588 (WD00505A)

1) 2) 3) ►

Basket handle Holders for the light guides and control units of the endoscopes Fluid distribution pipe with 7 adapter connection positions 1 connection position is located at the yellow tube.

The basket C588 is used to reprocess 2 small flexible endoscopes that do not povide any channels in the light guide of the endoscope (e.g. flexible bronchoscopes, ENT, cystoscopes, etc.). In total there are 7 connection positions for two small endoscopes available to connect them to the basket.

21