ENDODRY User Manual Rev G

2

Medical Device Regulation (EU) 2017/745 as amended

MEDIVATORS™, ADVANTAGE PLUS™ and ENDODRY™ are trademarks of Medivators Inc. ISA™ is a trademark of Cantel Medical (Italy) S.r.l. RAPIDAER™ is a trademark of Cantel (UK) Limited. All other company and product names are trademarks of their respective owner. LIT-00267 Rev G © 2021 Cantel Medical (Italy) S.r.l. All rights reserved. All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of Cantel. Cantel reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Cantel representative or Cantel customer service for more information.

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

3

TABLE OF CONTENTS

CHAPTER 1 - SYMBOLS AND SIGNAL WORDS Symbols ... 5 Signal Words ... 5 CHAPTER 2 - SAFETY INSTRUCTIONS / INSTRUMENT SET-UP About this Manual ... 7 Intended purpose ... 7 Indications for Use ... 7 User’s Qualification ... 7 Equipment Combination ... 7 Contents ... 7 Precautions ... 8 Hazards of Laser Radiation ... 8 Doors ... 8 Air circulation ... 8 Service, Repairs and Modifications ... 9 Liability ... 9 Rights ... 9 Disposal... 9 How to report incidents………………………………………………………………………………………………9

CHAPTER 3 - TECHNICAL MANUAL Configurations ... 11 Construction ... 11 Operations of the ENDODRY™ Storage & Drying System ... 12 Optional Operations ... 12

CHAPTER 4 - SYSTEM SET-UP Power Supply ... 15 Compressed Air Supply ... 15 Network Connection ... 16

CHAPTER 5 - OPERATION OF THE UNIT Switching On/Off ... 17 Information Screen ... 17 Barcodes and Barcode Reader ... 18 ... 18 Process steps before storing an endoscope into the ENDODRY™ Storage & Drying System Endoscope Loading (only possible on front side) ... 19 Endoscope Loading with active SMART Connect-add-on (optional) ... 21 Endoscope Loading with Active Multibox add-on (optional) ... 25 Endoscope Loading with Active Transfer add-on (optional) ... 28 Endoscope unloading (on front and back side)... 32

4

CHAPTER 6 - DISPLAY CONTROL SOFTWARE General menu navigation ...36 On-Screen Keyboard...37 User Rights ...38 System Information ...38 Login/Logout as User or Admin ...40 Reset Drawers ...41 User ...42 Save, change & delete users...42 Import the user ...43 User- import of an USB-stick ...43 User-import of the data base (optional) ...44 Export the user data ...44 Updating Endoscope Lists ...44 Save, change & delete endoscopes...45 Import the endoscope ...45 Endoscope-import of an USB-stick ...45 Endoscope-import of a data base (optional) ...46 Export the endoscope ...46 Standard settings ...46 Process settings ...47 Network settings ...49 Default settings ...50 Diagnostic ...51 License settings ...52 SMART Light (optional) ...52 SMART Connect (optional) ...53 HIS Interface (optional)...54 Network print (optional) ...55 Label printer (optional) ...55 Sensors (optional) ...56 Multibox (optional) ...57 Transfer (optional) ...57 Finish the program ...57

CHAPTER 7 - SERVICING Cleaning and Disinfection ...59 Service-interval ...59 General Maintenance and Repair Information ...59 Consumables………………………………………………………………………………………………………. 59

CHAPTER 8 - MESSAGES AND TROUBLESHOOTING Errors and warnings in the message line ...61 Troubleshooting ...61

CHAPTER 9 - REPORTS... 63 CHAPTER 10 - TECHNICAL DATA ... ..65 CHAPTER 11 - TECHNICAL SERVICE INFORMATION Limited Warranty ...69

CHAPTER 1

5

SYMBOLS AND SIGNAL WORDS Symbols Definitions of symbols which are affixed on the device:

Caution! High Voltage!

Manufacturer.

Do not dispose of the ENDODRY™ Storage & Drying System as residual waste.

Date of manufacture.

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

Power

Read instructions before using equipment!

Catalogue number

Medical Device.

Fuse

CE mark.

Serial number

Generic warning

Signal Words The following signal words are used in this operating manual:

CAUTION ! Indicates important and useful information.

WARNING ! SHOWS IMPORTANT INFORMATION ON SAFETY!

Note: A note refers to important information to which you should pay special attention.

6

NOTES

CHAPTER 2

7

SAFETY INSTRUCTIONS / INSTRUMENT SET-UP About this Manual This manual contains important information for the operation of the storage cabinet. It also explains the loading and unloading process for the endoscopes and the menu navigation. This manual contains no references to current techniques of endoscopy reprocessing and must not be used as a teaching guide. Reading this manual and observing the safety information is part of the obligations of the device operator. Not following the manual might lead to injury of the patient or damaged endoscopes. If you still have any questions after reading this manual please do not hesitate to contact your local Cantel Office.

Intended Purpose

Endoscope storage cabinet with drying functions

Indications for Use This storage cabinet is used for storing and drying flexible endoscopes which have been previously cleaned and high-level disinfected in a validated endoscope reprocessor. Please also refer to the operating manuals of the endoscopes.

WARNING ! ONLY USE ENDOSCOPES THAT HAVE BEEN PREVIOUSLY REPROCESSED OR CLEANED AND HIGH-LEVEL DISINFECTED!

User’s Qualification This storage cabinet may only be used by trained personnel. The user must have sufficient technical training regarding the usage of the instrument. It is the user’s responsibility to assure functional reliability and correct operation so that the instrument is safe and operates correctly before use.

Equipment Combination The ENDODRY™ Storage and Drying System provides compatibility with the cassette/load carrier of the RAPIDAER™ Endoscope Reprocessor and MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessors and can be also used in combination with the MEDIVATORS™ DSD and MEDIVATORS™ ISA™ Automated Endoscope Reprocessors.

Contents Remove the storage cabinet and the provided accessories from its packaging with care. Make sure that the supplied parts are complete and check for possible damages caused during transportation. CAUTION ! Please inspect the equipment upon arrival and check for any evidence of shipping damage. Any queries or complaints can be resolved immediately with the manufacturer or supplier. Please do not use faulty equipment!

8

The packaging includes the following: • • • • • •

1x ENDODRY™ Storage and Drying System 1x barcode reader with cable and holder (2x barcode readers for two-sided version) 1x power cord 1x pneumatic tube with quick connector 1x operating manual 1x LAN cable

Destination Kits for each market are available and which contain a power cord and operating manual. These Kits are supplied separately to the cabinet.

Precautions The device may only be transported in an upright position. The alignment of the device at the installation site should be performed by at least two people. Place the equipment on solid and flat surface only. Remove the packaging with care! The device may only be used in healthcare or decontamination facilities according to national recognised standards. Locate the device in a way that the electrical switch for the power supply is easy to reach. Removing the plug from the power supply serves as the means of isolation. To avoid potential hazards the unit must be connected correctly. The unit must be connected using a power connection suitable for the power cord provided. The power cable cannot be replaced by inadequately sized power cable. The power connector may only be put into an electrical earth protection contact outlet. Operating the device in explosive areas is prohibited. Any additional electrical work should only be performed by a suitably qualified electrician. Under normal intended use, the device does not come into contact with the patient and the user does not come into contact with hazardous and/or biological substances since the endoscope must be previously reprocessed and cleaned/high level disinfected.

Hazards of Laser Radiation To read the bar codes, a laser beam is used. Laser radiation can cause irreparable damage to the eyes and the skin. How to protect yourself from hazards in general: •

Do not look into the beam or reflections from shiny surfaces, even with optical instruments.

•

Avoid long and direct radiation on your skin.

•

Only actuate the storage cabinet if the laser scanner is fixed in its holder. WARNING! LASER RADIATION CAN CAUSE IRREPARABLE DAMAGE TO THE EYES AND THE SKIN! LASER CLASS 1: DO NOT LOOK INTO THE BEAM DIRECTLY!

Doors The doors of the ENDODRY™ Storage and Drying System protect the endoscopes during the storage. The drying phase can only be started by closing the door. In the case of an opened door the drying phase is interrupted and the control switches to the storage phase. In the two-sided version of the ENDODRY™™Storage and Drying System the doors cannot be opened simultaneously due to the opposing door lock.

Air circulation The drying of the endoscope’s outer surface can be accelerated with the circulation of the air. To achieve this eight fans are placed inside the ENDODRY™ Storage and Drying System. WARNING! DO NOT PUT FINGERS INTO THE FAN! PROTECT FANS AND FILTERS AGAINST SPLASHING WATER!

9

Service, Repairs and Modifications Annual preventative maintenance is recommended. For service information, please contact your local Cantel Office. NOTE: Due to the special safety regulations for medical-technical appliances any servicing such as regular check-ups, repairs, modifications, calibrations etc. must only be conducted by the manufacturer or by persons explicitly authorised by the manufacturer. CAUTION! Cantel does not assume liability for injuries or damages which result from repairs conducted by non-authorised staff.

Liability Cantel is only responsible for the effects on safety, reliability and functionality of the device if: • The assembly, extension, readjustment, modifications or repairs are carried out by persons who are authorised by Cantel. •

The electrical configuration of the premise is in compliance with the specification of the respective country.

•

The device is used in accordance with the operating instructions as advised in this manual.

Rights All rights to this manual in particular the right of reproduction and the right of publication as well as translation are reserved. No part of this manual may be copied in any way (duplicate, microfilm or other methods) or be copied/ processed/distributed using electronic systems without prior written consent by the manufacturer. The information in this manual is subject to change or extension without notice and does not represent a commitment by the manufacturer. Errors and technical modifications excepted.

Disposal The storage cabinet is categorised as an electric device. In accordance with 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 should be collected separately. Contact your supplier for return of the device and/or an available recycling collection system in your country.

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

10

NOTES

CHAPTER 3

11

TECHNICAL MANUAL Configurations Various versions of the ENDODRY™ Storage and Drying System are available including systems designed to interface with: - MEDIVATORS™ ISA™ Endoscope Reprocessor; - MEDIVATORS™ ADVANTAGE PLUS™ Automated Endoscope Reprocessor; - MEDIVATORS™ DSD Endoscope Reprocessor; - RAPIDAER™ Endoscope Reprocessor.

In the two-sided pass-through version there is a door, a display and a bar code reader on each side. The loading process of endoscopes will be carried out on the front side only whilst the unloading process can be performed on either side.

Construction connector for: • • •

power supply voltage compressed air LAN on-off switch

pneumatic system (with air filter) and electronics

bar code reader

control system with touch display glass door (not shown)

on the rear of the two-sided version: • second door • touch display • bar code reader

- MEDIVATORS™ DSD

- MEDIVATORS™ ADVANTAGE PLUS™

- RAPIDAER™

connection block drawer system*

Figure 1. ENDODRY™ Storage and Drying system without door

*Note: a dedicated version of ENDODRY™ Storage and Drying System is available for use with the RAPIDAER™ Endoscope Reprocessor

12

Operation of the ENDODRY™ Storage and Drying System The storage cabinet has the following main functions: •

Drying and Storage functions for endoscopes after reprocessing -

horizontal storage of up to eight endoscopes using additional transport cassette/load carrier (sold separately)

-

circulation of filtered air through all channels of flexible endoscopes (e.g. biopsy, water, jet channel) of every manufacturer after reprocessing circulation of filtered air around the interior space of the ENDODRY™™ Storage and Drying System control with up to three different air pressures reduction of the air pressure after a minimum time of circulation error message management optional: interface between reprocessing and operating room (two-sided version)

•

•

Documentation and visualisation of important information for the reprocessing room - user I.D. via barcode reader - endoscope I.D. and drawer placement via barcode reader - documentation of drying and storage time by endoscope position - recording and storage of all process data - warning in case of failure or exceeded storage time Simple and safe operation - touch display - door lock with user authorisation via barcode reader

Optional Operations To enhance the functionality of the ENDODRY™ Storage and Drying System the following add-ons are available to purchase: •

SMART Light The storage cabinet is equipped with LED lights. The colour changes according to the storage status of the endoscopes. green - storage phase blue - drying phase red - failure NOTE: Options are not available in all regions.

•

SMART Connect * In connection with a Cantel AER: A security query, which verifies the correct reprocessing, runs if an endoscope is loaded. The maximum time between reprocessing and loading an endoscope can be set (see Chapter 6). By loading an endoscope a warning appears if the reprocessing was faulty or the maximum transport time is exceeded. Furthermore, the user and endoscope information of an ADVANTAGE PLUS™ Reprocessor can be imported to the ENDODRY™ Storage and Drying System on demand (see Chapter 6) or automatically at up to three tim es per day (see Chapter 6).

•

HIS Interface * The HIS add-on releases process and master data from the ENDODRY™ Storage and Drying System to the hospital information system. Process data (loading and unloading information of each endoscope) is released permanently. The release of master data (saved user and endoscope data) can be set in the control panel (see Chapter 6).

13

•

Network Print All relevant process data can be printed on a controlled network printer after unloading an endoscope. An application runs on a desktop PC and controls the print process. The desktop PC and the network printer have to be provided by the operator. A network connection between ENDODRY™ Storage and Drying System, desktop PC and network printer is required.

•

Label Printer All relevant process data can be printed on a label printer after unloading an endoscope. A network connection between ENDODRY™ Storage and Drying System and label printer is required.

•

Sensors * Critical parameters such as temperature, humidity and air flow are controlled and recorded. In case of deviation of the adjustable limits a new or extended drying phase is initiated to return to the desired climatic state in the ENDODRY™ Storage and Drying System.

•

Multibox * For endoscopes with few channels it is possible to store more than one endoscope in the same cassette (e.g. bronchoscopes). This add-on enables the storage and recording of up to four endoscopes in one cassette. Not available on ENDODRY™ Storage and Drying System variants that are compatible with the RAPIDAERTM Endoscope Reprocessor load carrier. Transfer * After storing an endoscope in centralised ENDODRY™ Storage and Drying System in the endoscopy area the storage process can be continued in a decentralized ENDODRY™ Storage and Drying System. The process steps in the different storage locations can be recorded completely.

•

14

NOTES

CHAPTER 4

15

SYSTEM SET-UP

CAUTION! Please carefully read the User Manual before operation! CAUTION! All connections to 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 earth conductor. WARNING! LASER RADIATION CAN CAUSE IRREPARABLE DAMAGE TO THE EYES AND SKIN! LASER CLASS 1: PREVENT DIRECT EYE EXPOSURE TO THE BEAM.

Power Supply Use only the power cable supplied with the equipment for connecting the equipment to the power supply. Ensure to the correct power supply voltage is available and connect the device only to a earth grounded electrical outlet. The power cable of the ENDODRY™ Storage and Drying System serves as a means of electrical isolation. If this is not easily accessible an additional electrical isolator must be installed by the operator (for example a central emergency stop).

Compressed Air Supply A connection (inner diameter 6 mm) with quick connector establishes the compressed air supply to the ENDODRY™™ Storage and Drying System. The connection is allowed only to systems with filtered and compressed air specifications (see Chapter 10). WARNING! NOT FOLLOWING THE USER MANUAL MIGHT LEAD TO ERRORS IN THE CIRCULATIONS OF AIR!

power cable LAN cable Note: it must be connected to devices compliant to IEC 60950-1. air connection, quick coupling

16

Network Connection The storage cabinet can be integrated into the hospital network via LAN connection. This allows access to the report files and a software update by the service technician. A LAN connection to the hospital network is necessary to use the operation of the add ons SMART Connect, SMART Update or HIS interface. The relevant peripheral devices must be integrated in the same network group. 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.

Check the flow of the channel connection port (only model ENDODRY™ Storage & Drying System and not ENDODRY™ Storage & Drying System one-click) Before the first operation and during maintenance all seven channel connection ports for each drawer need to be checked for correct air flow.

To begin this, the drying phase of 0.5 Bars has to be activated in the diagnostic menu. For the test an air flow tester is put on to every channel connection port in turn while the valve pin is pressed. The float of the air flow tester needs to reach the red marked range completely.

CAUTION! Channel connection ports with low air flow deteriorate the drying results of endoscopes. It is recommended to change these parts with replacement equipment of the manufacturer.

CHAPTER 5

17

OPERATION OF THE UNIT Switching On/Off After connecting power supply, air supply and LAN connection the device can be put into operation. Turn on the storage cabinet using the on/off switch on the front of the ENDODRY™ Storage and Drying System. The blue light within the switch lights up and the touch display shows various information (see Chapter 3 and 5). In the version with two-sided design the displays are distinguished as follows: •

front side= with on-off switch

•

back side = without on-off switch

Information Screen (in two-sided version: the same at front and back side) The control panel with integrated touch display regulates all processes and visualises the operation. On the main screen the following information is displayed: Drawer number Stored endoscopes with type

Drying time: hh:mm

Status display - free drawer - drying progress - channel drying complete - warning/error Barcode

Status display: -

free = free drawer

-

in progress = endoscope has been loaded, drying of internal channels has been initiated



-

channel drying complete = the set drying time has been reached for internal channels



-

warning/error = maximum storage time is exceeded or pressure malfunction during storage has occurred

18

Barcodes and Barcode Reader Barcodes are used to identify users, endoscopes and drawers. These barcodes will be generated and delivered by Cantel. Barcodes for endoscopes and users must not be assigned twice. Make sure that all endoscopes are prepared with different barcodes and all users are registered in the device. The ENDODRY™ Storage and Drying System must be operated by authorised and registered staff only. Using the barcode reader the barcodes of users, endoscopes and drawers barcodes can be read and entered to the system.

Process steps before storing an endoscope into the ENDODRY™ Storage and Drying System To ensure the drying of the inner channels and the outer surfaces of an endoscope in the ENDODRY™ Storage and Drying System the following steps should be observed before storing: •

For an optimal drying process of the loaded endoscopes the relative humidity should not exceed 40%.

•

The final step in reprocessing the endoscope should include purging the inner channels of the endoscope with filtered and compressed air.

•

The endoscope has to be connected correctly to the Hookup (see User Manual according to the connector type)

•

The residual moisture in endoscope channels and on the outer surfaces should be less than 30 ml.

•

Excess moisture on the endoscope surface and/or the cassette/load carrier should be reduced by either shaking the cassette/load carrier, wiping the endoscope and cassette/load carrier with a sterile lint-free and highly absorbent cloth, or using a compressed air supply (paying particular attention to the angulation controls and endoscope contact points) before storing in the ENDODRY™ Storage and Drying System. Wearing of appropriate PPE is recommended.

19

Endoscope Loading (only possible on front side) WARNING! USE ONLY ENDOSCOPES WHICH HAVE BEEN REPROCESSED OR PREVIOUSLY CLEANED AND HIGH-LEVEL DISINFECTED! CAUTION! THE DOOR WILL NOT OPEN UNTIL AN AUTHORISED USER IS LOGGED IN (VIA BAR CODE READER)! CAUTION! THE TWO-SIDED VERSION, THE OPERATION CANNOT BE PERFORMED ON BOTH SIDES SIMULTANEOUSLY. THE UNUSED SIDE WILL DISPLAY A MESSAGE OF “SYSTEM BUSY”. CAUTION! DO NOT INSERT A TRANSPORT CASSETTE/ LOAD CARRIER OR HOOKUP WITHOUT AN ENDOSCOPE INTO THE ENDODRY™ STORAGE & DRYING SYSTEM. EMPTY TRANSPORT CASSETTE/LOAD CARRIER INCREASE THE CONSUMPTION OF COMPRESSED AIR!

Procedural method: Loading an Endoscope *Note: Images are representative, cassettes and load carriers can vary depending on the model. Interface language will be country specific. 1.

user logs in via barcode reader

2.

open the door

3.

scan the barcode of the endoscope which has been loaded

4.

insert the endoscope (with transport cassette/load carrier) into a free drawer and connect the appropriate hookup

20

5.

Interlock the connection block

6.

Scan the drawer

7.

Slide the drawer in

or connect CPC quick coupling as appropriate

8.

“Scan the next endoscope or close the door” is displayed