endoSTORE BHT and one-click Operating Manual Rev E

Medical Device Regulation (EU) 2017/745 as amended

endoSTORE™ and INNOVA™ are trademarks of Cantel (Production) Germany GmbH. All other company and product names are trademarks of their respective owner. LIT-00268 Rev E The text of this operating manual is protected by copyright. This operating manual may not be copied or reproduced in whole or in part without the consent of Cantel. Technical changes, which serve the further development of the device, are subject to change without notice. ©2021 Cantel Medical (Italy) S.r.l. All rights reserved. Cantel Medical (Italy) S.r.l. Via Laurentina, 169, 00071 Pomezia (RM) Italia Tel: +39 06 9145399 | Fax: +39 06 9146099 [email protected] | www.cantelmedical.eu

ii | endoSTORE™ BHT / endoSTORE™ one-click - Endoscope Storage Cabinet with drying function

Index 1

Symbols and signal words ... 2

1.1

Symbols ... 2

1.2

Signal words ... 2

2

Safety instructions / Installation of the device ... 3

2.1

About this operating manual ... 3

2.2

End use ... 3

2.3

Qualification of the user... 3

2.4

Device combinations ... 3

2.5

Scope of delivery ... 4

2.6

Safety measures at the installation site ... 4

2.7

Hazards due to laser radiation ... 4

2.8

Doors ... 5

2.9

Circulating air ... 5

2.10

Warranty ... 5

2.11

Services, repairs, modifications ... 5

2.12

Accountability ... 6

2.13

Rights ... 6

2.14

Disposal ... 6

2.15

How to report incidents ... 6

3

Device description ... 7

3.1

Versions... 7

3.2

Design... 7

3.3

Functions of the endoSTORE™ Storage Cabinet... 8

3.4

Optional functions... 8

4

Comissioning ... 10

4.1

Power/mains wire ... 10

4.2

Compressed air ... 11

4.3

Network connection... 11

4.4

Nozzle flow test (Model BHT)... 12

5

Operating the device ... 13

5.1

On/Off switching ... 13

5.2

Information display ... 13

5.3

Barcodes and barcode scanners ... 14

5.4

Procedures before storing an endoscope in the endoSTORE™ Storage Cabinet ... 14

5.5

Storing endoscope (only possible from the front side) ... 14

5.7

Storage of endoscope with active transfer add-on (optional) ... 21

5.8

Remove endoscope (via front and back) ... 25

6

Control software ... 28

6.1

General menu navigation ... 29

6.2

Screen keyboard ... 30

6.3

User rights ... 31

6.4

Information display ... 31

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6.5

Log in/log out as user or admin... 33

6.6

Reset storage areas

6.7

User

... 34

... 35

6.7.1 Create, change & delete users... 35 6.7.2 Importing Users ... 36 6.7.2.1 User import from a USB stick ... 36 6.7.2.2 User import from the database (optional) ... 37 6.7.3 Exporting user ... 37 6.8

Endoscope

... 37

6.8.1 Create, change & delete endoscopes ... 38 6.8.2 Import endoscopes... 38 6.8.2.1

Endoscope import from a USB stick ... 38

6.8.2.2 Endoscope import from the database (optional) ... 39 6.8.3 Exporting endoscopes ... 39 6.9

Standard settings

... 40

6.10

Process Settings

... 41

6.11

Network Settings

... 44

6.12

Factory settings ... 44

6.13

Diagnosis

6.14

License Settings

6.15

SMART Light (optional)

6.16

SMART Connect (optional) ... 49

6.17

HIS Interface(optional) ... 50

6.18

Network Printing (optional) ... 51

6.19

Label Printer (optional) ... 51

6.20

Sensor system (optional) ... 51

6.21

Transfer (optional) ... 53

6.22

Exit program

7

Maintenace ... 54

7.1

Cleaning and disinfection ... 54

7.2

Service schedule ... 54

7.3

General maintenance and repair ... 54

8

Messages and troubleshooting ... 55

8.1

Errors and warnings in the message line... 55

8.2

Troubleshooting ... 55

9

Reports ... 57

10

Technical data... 58

11

Technical service information ... 60

... 46 ... 48 ... 48

... 53

iv | endoSTORE™ BHT / endoSTORE™ one-click - Endoscope Storage Cabinet with drying function

1

Symbols and signal words

1.1

Symbols

Below are the meanings of the symbols that are affixed to the device:

Caution! High Voltage!

Refer to instructions!

Do not dispose of the endoSTORETM Cabinet as residual waste.

Medical Device.

Before opening the control drawer, always disconnect the device from the main power supply.

CE mark.

Power

Manufacturer.

Catalogue number

Date of manufacture.

Fuse

Serial Number

Generic warning

1.2 Signal words The following signal words are used in the chapters of this operating manual: Caution! Indicates important and useful information.

Warning! Shows important information on safety!

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2 2.1

Safety instructions / Installation of the device About this operating manual

The operating manual contain important information for the use of the storage cabinet. Additionally, the storage and removal of endoscopes and the menu navigation are explained. This operating manual does not contain any information on current preparation techniques and is not suitable as a teaching manual. Reading these operating manual and observing the safety instructions is part of the user's obligations.Noncompliance with these operating manual can lead to injuries to the patient and damage to the endoscopes. If you have any questions after reading this manual, please contact Cantel service department.

2.2

End use

The storage cabinet is used to store and dry flexible endoscopes that have previously been cleaned in a validated preparation machine. The endoSTORE™ BHT Storage Cabinet is compatible with the cassette system from Cantel and the connection system to the INNOVA™ Reprocessing Machine. Please also observe the operating manual for the endoscopes. Warning! Only use endoscopes that have been previously reprocessed or cleaned and disinfected. The device does not enter in contact with the patient. It is not intended the use of hazardous substances/mixture that could enter in contact with the patient or the user. There is no risk that the user enters in contact with biological residues since the endoscope must be prevouusly reprocessed or cleaned and high-level disinfected.

Intended Purpose Endoscope storage cabinet with drying functions.

2.3

Qualification of the user

The storage cabinet may only be operated by trained personnel from the hygiene department. The user must have received adequate training in the use of the device. Before using the device, the user must ensure that the device is in proper working order and in good working order.

2.4

Device combinations

The endoSTORE™ BHT Storage Cabinet has been specially developed for the transport cassettes of Cantel and should only be operated with this type. The transport boxes are an optional part of the INNOVA™ Reprocessing Machine. The endoSTORE™ one-click Storage Cabinet can also be operated in combination with transport cassettes. These are part of the optional scope of delivery of the storage cabinet.

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2.5

Scope of delivery

Carefully remove the device and the supplied accessories from the packaging. Check the delivery for integrity and for any damage caused by transport. Caution! Should the delivery give cause for complaint, please contact the manufacturer or supplier immediately. Do not use the device! The packaging includes the following: • 1x endoSTORE™ BHT Storage Cabinet or endoSTORE™ one-click Storage Cabinet • 1x barcode scanner with wire and holder (2x barcode scanner for two-sided version) • 1x power supply wire (only in EU area) • 1x pneumatic connection hose with quick coupling • 1x Operating manual • 1x LAN-wire

2.6

Safety measures at the installation site

The device may only be transported in an upright position. The use of a lift truck (in conjunction with a transport pallet) or a furniture lifting roller is recommended for transport. Alignment of the unit at the installation site must be carried out by at least two persons. Only place the device on a firm, level ground. Remove the packing material carefully. The device may only be used in rooms that are equipped according to national standards. It must be positioned in such a way that the disconnecting device can be easily reached from the mains. The mains wire or a suitable device on the building side serves as a disconnecting device. Only use the supplied power wire for the mains connection (only in the EU area). Outside the EU area only a tested mains wire with plug may be used. In principle, the mains wire must not be replaced by insufficiently dimensioned mains cables. The power plug may only be inserted in a grounded earthing contact socket. The operating of the device in hazardous areas is prohibited.

2.7

Hazards due to laser radiation

A laser scanner is used to scan the barcodes. Laser radiation can cause irreparable damage to the eyes and damage the skin. How to protect yourself from dangers in general: • Do not look directly in the beam or in reflections on bare surfaces, even with optical devices. • Avoid prolonged direct radiation to skin. • Do not operate the storage cabinet unless the laser gun is in its holder. Warning! Laser radiation can cause irreparable damage to eyes and skin! Class 1 laser: Do not look directly in the beam.

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2.8

Doors

The doors of the storage cabinet protect the endoscopes during storage. The drying phase can only be started with the door closed. If the door is not closed, the drying phase is interrupted and the controller switches to the storage phase. With the two-sided version of the endoSTORE™ Storage Cabinet, the doors are interlocked in opposite directions, i.e. both doors cannot be opened at the same time.

2.9

Circulating air

The drying of the outer skin of the endoscopes can be accelerated by circulating the air. The interior of the endoSTORE™ Storage Cabinet contains eight fans for this purpose.

Warning! Do not reach inside the fans! Protect the fans and filters from splash water!

2.10 Warranty Within the warranty period, defects in the device that are due to a material or manufacturing fault will be rectified free of charge. Warranty services do not cause an extension or a new start of the warranty period. The manufacturer does not provide any guarantee: • External intervention • on removal/change of the serial number • in the case of conversions or attachments that indicate the cause of the defect • Repairs that have not been carried out by service personnel authorised by Cantel • Damages caused by improper use or non-compliance with the operating manual are excluded

from the warranty. Likewise, damage due to external influences, in particular overvoltage, is not covered under warranty. In all other respects, our General Terms and Conditions of Business apply (can be read at www.cantelmedical.eu).

2.11 Services, repairs, modifications The service interval is 12 months. Please inform your regional service centre in case of maintenance. Note: All services such as regular testing, repairs, modifications, calibrations, etc. may only be carried out by the manufacturer or by persons expressly authorised by the manufacturer with regard to the special safety regulations for medical-technical devices.

Caution! Cantel accepts no liability for injury or damage resulting from repairs carried out by unauthorised persons

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2.12 Accountability As the manufacturer of the device, Cantel considers itself responsible for the impact on the safety, reliability and performance of the device only if: • Installation, expansion, readjustment, modifications or repairs are performed by Cantel authorised service personnel. • the electrical installation of the room in question meets the requirements of the country in question. • the device is used in accordance with the instructions for use.

2.13 Rights All rights to this manual, in particular the right of reproduction, distribution and translation, are reserved. No part of this manual may be reproduced in any form (by photocopying, microfilm or other methods) or processed, duplicated or distributed using electronic systems without the prior written consent of the manufacturer. The information contained in this manual can be changed or extended without prior notice and does not represent any obligation on the part of the manufacturer. Errors and technical changes are subject to change.

2.14 Disposal This storage cabinet belongs to the category electrical appliances. In accordance with the provisions of Directive (European Union) 2012/19/EU on waste electrical and electronic equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste but must be collected separately.

Contact your supplier for return of the device and/or an available recycling collection system in your country.

2.15 How to report incidents Any serious incident that occurs in relation to the endoSTORETM Storage Cabinet should be reported to Cantel Medical (Italy) S.r.l. and to the local Competent Authority.

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3 3.1

Device description Versions

Different versions of the endoSTORE™ Storage Cabinet are available. The two-sided version has an additional door, a display and a barcode scanner on the back of the device. This pass-through variant offers a separating function between the hygienic and examination areas. Loading is only carried out from the front of the device, removal from the front and rear of the device.

3.2

Design

Pneumatics and electronics

Connections for • Mains voltage • Compressed air • LAN

Barcode scanner On/off switch Glass door (faded out) Touch display with controls

on the rear side of the double-sided version: • second door • Touch display • Scanner

Connection possibility

Pull-out system

Exemplary figure, without door

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3.3

Functions of the endoSTORE™ Storage Cabinet

The storage cabinet has the following main functions: • Storage of reprocessed endoscopes including drying function − horizontal storage of up to eight endoscopes − Adaptation via a transport box (accessory) − Circulation of filtered compressed air in biopsy, air-water and jet channel of flexible endoscopes of all manufacturers after reprocessing − Circulation and filtering of the air inside the endoSTORE™ Storage Cabinet − Control with up to three different air pressures − Reduction of the air pressure after reaching a minimum circulation time − Error message management − optional: Interface between preparation and examination room (with two-sided design) • Acquisition and visualization of important information for the reprocessing room − Users with barcode scanners − Endoscope and extraction via barcode scanner − Recording storage and drying time − Recording and storage of all process data − Warning in case of error or exceeded storage time • simple and safe operation − Touch display − Door locking with user authorization using barcode scanner

3.4

Optional functions

To extend the functions of the endoSTORE™ Storage Cabinet, the following add-ons are available and can be purchased as options: • SMART Light The storage cabinet is equipped with an LED lighting system which indicates the storage status of the endoscopes by changing colour. green – storage phase blue – drying phase red – fault

• SMART Connect In connection with an appropriate reprocessing machine, a safety query is carried out for each storage, which checks the correct reprocessing. For this purpose, a maximum permissible time between reprocessing and storage of an endoscope can be defined (see section 6.16). If reprocessing was faulty or if the maximum permitted time was exceeded, a warning appears when the endoscope is put in storage. Furthermore, the user and endoscope data can be imported from a reprocessing machine by a click (see section 6.7.2.2 and 6.8.2.2) or automatically at adjustable intervals (see section 6.16).

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• HIS Interface Process and master data from the storage cabinet can be approved for the hospital information system via the HIS interface. There is a permanent release of the process data (information on storage and removal of each endoscope). The release of the master data (created user and endoscope data) can be defined in the control panel (see section 6.17).

• Network Printing All relevant process data can be printed out via a controlled network printer. An application on a deployed desktop PC forwards the print job to a printer provided by the operator. Required: Network connection, desktop PC and printer

• Label Printer A label printer provided by Cantel prints out the relevant process data. Required: Network connection

• Sensor system Critical values like temperature, humidity and flow rate are controlled and recorded. By means of adjustable limit values, a new or prolonged drying phase is initiated when exceeded in order to restore the desired climate in the endoSTORE™ Storage Cabinet.

• Transfer After storage in a central cabinet in the endoscopy area, documented storage in the decentralized area is possible. The process steps at the various storage locations can be seamlessly recorded.

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4

Comissioning Caution! Please read the respective user manual before operation carefully! Caution! All connections of the power supply and compressed air must be established before switching on the device! Caution! To avoid the risk of electric shock, the device must be connected to the power supply with a protective conductor! Warning! Laser radiation can cause irreparable damage to the eyes and skin! Laser Class 1: Prevent direct eye exposure to the beam.

4.1

Power/mains wire

Use a tested mains wire to connect the units to the mains voltage. Make sure that the mains voltage indicated on the devices is correct. Only connect the devices to a grounded earthing contact socket. The mains wire of the endoSTORE™ Storage Cabinet serves as a disconnecting device from the mains supply. If this cannot be achieved without problems, a suitable device (e.g. central emergency stop) must be installed by the operator.

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4.2

Compressed air

The compressed air supply of the endoSTORE™ Storage Cabinet is ensured via a connection (nominal diameter DN 6 or ¼'') with quick coupling. Connection is only permitted to systems with filtered compressed air (for specifications see chapter 10). Warning! Not following the manual might lead to disturbance in circulations of air!

Potential equalization plug

Mains wire LAN wire Note: it must be connected to devices compliant to IEC 60950-1

Air connection, quick coupling

4.3

Network connection

The storage cabinet can be integrated in the hospital network via a LAN connection. This enables remote maintenance, access to the reports and a possible software update by the service technician. To use the function of the add-ons SMART Connect, HIS Interface, Network Printing, Label Printer and Transfer, a LAN connection to the hospital network is required. The corresponding peripheral devices must be located in the same network group.

Hospital network

Processing machine

TCP-Ports: 80; 20; 21; 445; 1433; 1034; 37223 UDP-Ports: 80; 1900 LM- authentication for network logons LAN cable must be connected to devices compliant to IEC 60950-1.

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4.4

Nozzle flow test (Model BHT)

During maintenance, all seven nozzles of each pull-out must be checked for flow. For this purpose the drying phase of 0.5 bar must be set in the diagnosis menu.

For the test, the float-type flow meter is placed on the respective nozzle and the supply air pin is pressed. The float must reach the marked red mark.

Caution! Nozzles with too low flow worsen the drying result of the endoscopes. It is strongly recommended to replace them with spare parts from the manufacturer.

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5

Operating the device

5.1

On/Off switching

After all necessary connections have been made, the device can be commissioned Switch on the storage cabinet with the mains switch on the front of the unit. The blue light inside the switch lights up and the touch display shows various information (see chapter 3.2 and 5.2). For the device variant with two-sided design, the sides are differentiated as follows: • Front panel with on/off switch • Rear panel without on/off switch

5.2

Information display

(for two-sided version: identical for front and rear of device) Via the control system with integrated touch display, the procedures are regulated and the process is visualized.

On the main screen the following information is displayed: drawer number stored endoscopes with type bar code Drying time: hh:mm

status display - free - in progress - finished - warning

Status display: free

= free drawer

in progress

= endoscope has been loaded, drying time (1 & 2) runs

f nished

= the set drying time has been reached

warning

= maximum storage time is exceeded or pressure malfunction during storage

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5.3

Barcodes and barcode scanners

Barcodes are used to identify users, endoscopes and pull-outs. These barcodes are created and issued by Cantel. No barcodes may be assigned twice to endoscopes or users. Make sure that your endoscopes have different barcodes and that all users are registered. The device can only be operated by authorised and created users. The barcode scanner is used to read the users, endoscopes and pull-outs and enter them in the system.

5.4

Procedures before storing an endoscope in the endoSTORE™ Storage Cabinet

To ensure the drying of the inner channels and the outer surface of an endoscope in the endoSTORE™ Storage Cabinet, the following points should be observed before storage. • For an optimized drying process of the load, the relative humidity of the environment should not exceed 40 %. • The last step in the reprocessing of the endoscope should include the thorough blowing out of the inner channels with filtered compressed air. • The endoscope must be correctly connected via the connector (see operating manual of the corresponding connector). • Larger amounts of residual moisture on the endoscope or box should be removed by shaking offand briefly placing the box on an absorbent substrate. • To reduce residual moisture in inaccessible places on the outer surfaces, the endoscope and, if necessary, the box before storing in the endoSTORE™ Storage Cabinet should be wiped with a lint-free, absorbent cloth (e.g. between the steering wheels and on the contact surfaces). The wearing of disposable gloves is recommended. • The residual moisture in the endoscope channels and on the outer surfaces should be less than 30 ml.

5.5

Storing endoscope (only possible from the front side)

Warning! Use only endoscopes which have been reprocessed or cleaned and disinfected previously!

Caution! The door will not open as long as no user is logged in (via bar code reader)!

Caution! In the two-sided version the operation cannot be performed on both sides simultaneously. On the unused side the message “System Busy” is displayed. Caution! Do not connect connectors without endoscope in endoSTORE™ Storage Cabinet! These increase the demand for compressed air!

14 | endoSTORE™ BHT / endoSTORE™ one-click - Endoscope Storage Cabinet with drying function

Procedure: 1.

Operator logs in using the barcode scanner

2.

Open the door

3.

Scan the barcode of the endoscope to be inserted

4.

Insert endoscope (if necessary with transport box) in a vacant pull-out

5.

Lock connector

(endoSTORE™ BHT Storage Cabinet)

or connect CPC quick coupling

(endoSTORE™ one-click Storage Cabinet)

endoSTORE™ BHT / endoSTORE™ one-click - Endoscope Storage Cabinet with drying function | 15

6.

Scan pull-out

7.

Slide in pull-out

8.

"Scan another endoscope or close door" is displayed

16 | endoSTORE™ BHT / endoSTORE™ one-click - Endoscope Storage Cabinet with drying function

Case9a. Scan next endoscope

lnsert: Repeat steps 3 to 8 Removal:see section 5.8

Case9b. When cance//ing or closing the door System starts the drying process Storage time starts counting 10.The information display shows the pull-outs with the stored endoscope types and the storage status. Far further information on the status display see chapter 5.2.

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