endoSTORE Vertical Operating Manual Editon 01 Rev 01 March 2016

This manual contains information protected by copyright laws. All rights are reserved. The manual may not be copied or duplicated, in its entirety or in part, without the explicit approval of ESCAD Medical GmbH. We reserve the right to make technical changes to the instrument prior to notice. Copyright ESCAD Medical GmbH 14.03.2016

Manufactured by: ESCAD Medical GmbH Zur Öhmdwiesen 5 D-88633 Heiligenberg Germany phone +49 (0) 7554 / 9999-500 fax +49 (0) 7554 / 9999-558 www.escad-medical.de [email protected]

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Index of contents 1

SYMBOLS AND SIGNAL WORDS ... 5

1.1 1.2 2

SAFETY INSTRUCTIONS / INSTRUMENT SET-UP ... 6

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 3

Power Supply ... 13 Compressed Air Supply ... 14 Network Connection... 14

OPERATION OF THE UNIT ... 15

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6

Versions ... 10 Construction ... 10 Operations of the endoSTORE® vertical ... 11 Optional Operations ... 11

START OF OPERATION ... 13

4.1 4.2 4.3 5

About this Manual ... 6 End Use ... 6 User’s Qualification ... 6 Scope of Delivery ... 6 Safety Measures at the Installation Site ... 7 Hazards of Laser Radiation ... 7 Doors ... 7 Air circulation ... 8 Warrantie... 8 Service, Repairs and Modifications ... 8 Liability... 8 Rights ... 9 Disposal... 9

TECHNICAL MANUAL ... 10

3.1 3.2 3.3 3.4 4

Symbols... 5 Signal Words ... 5

Switching On/Off ... 15 Information Screen ... 15 Bar Codes and Bar Code Reader ... 16 Process steps before storing an endoscope into the endoSTORE® ... 16 Endoscope loading (only possible on front side) ... 16 Endoscope Loading with active SMART Connect-add-on (optional) ... 20 Endoscope loading with active Multibox add-on (optional) ... 24 Endoscope loading with active Transfer add-on (optional) ... 27 Endoscope unloading (on front and back side) ... 30

DISPLAY CONTROL SOFTWARE ... 33

6.1 6.2 6.3 6.4 6.5

General menu navigation ... 34 On-Screen Keyboard ... 35 User Rights ... 36 System Information ... 36 Login/Logout as User or Admin ... 38

6.6

Reset Storage yards

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6.7

User 6.7.1 6.7.2

6.7.3

7

6.8

Endoscope ... 42 6.8.1 Save, change & delete endoscopes ... 42 6.8.2 Import the endoscope ... 43 6.8.2.1 Endoscope-import of an USB-stick... 43 6.8.2.2 Endoscope-import of a data base (optional) ... 44 6.8.3 Export the endoscope ... 44

6.9

Standard settings

... 44

6.10

Process settings

... 46

6.11

Network settings

... 49

6.12

Default settings

... 49

6.13

Diagnostic

6.14

License settings

6.15

SMART Light (optional)

... 53

6.16

SMART Connect (optional)

... 53

6.17

HIS Interface (optional)

... 54

6.18

Network print (optional)

... 55

6.19

Label printer (optional)

... 56

6.20 6.21

Sensors (optional) Multibox (optional)

... 56 ... 57

6.22

Transfer (optional)

... 58

6.23

Finish the programm

... 58

... 50 ... 52

SERVICING ... 59

7.1

7.2 7.3 8

... 40 Save, change & delete users... 40 Import the user... 41 6.7.2.1 User- import of an USB-stick ... 41 6.7.2.2 User-import of the data base (optional) ... 42 Export the user ... 42

Cleaning and Disinfection ... 59 7.1.1 Cleaning rear wall ... 59 7.1.2 Cleaning floor ... 61 Service-interval ... 62 General Maintenance and Repair Information ... 62

MESSAGES AND TROUBLESHOOTING ... 63

8.1 8.2

Errors and warnings in the message line ... 63 Troubleshooting ... 63

9

REPORTS ... 65

10

TECHNICAL DATA ... 66

11 TECHNICAL SERVICE INFORMATION ... 68

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1 Symbols and Signal Words 1.1

Symbols

Definitions of symbols which are affixed on the device:

Caution! High Voltage!

Do not dispose of the endoSTORE® as residual waste.

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

Refer to instructions!

1.2

Signal Words

The following signal words are used in this operating manual:

Caution! Indicates important and useful information.

Warning! Shows important information on safety!

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2 Safety Instructions / Instrument Set-Up 2.1

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 a service technician of ESCAD Medical GmbH.

2.2

End Use

This storage cabinet is used for storing and drying flexible endoscopes which were cleaned in a validated endoscope reprocessor before. The compatibility of the endoscopes can be confirmed on request of ESCAD Medical. The endoscopes must be connected via special connectors of ESCAD Medical GmbH to the compressed air system in endoSTORE® vertical. Please follow by connection the Application Notes of the connectors. Please also refer to the operating manuals of the endoscopes.

Warning! Only use endoscopes that have been previously reprocessed or cleaned and disinfected.

2.3

User’s Qualification

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

2.4

Scope of Delivery

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!

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The packaging includes the following:  1x storage cabinet endoSTORE® vertical  1x door lock (2x fort wo-sided version)  1x lock flap (2x for two-sided version)  1x bar code reader with cable and holder (2x for two-sided version)  1x power cord (only in European area)  1x pneumatic tube with quick connector  1x operating manual  1x LAN cable

2.5

Safety Measures at the Installation Site

The device may only be transported in an upright position or with the special packaging from ESCAD Medical. For transporting the device the use of a truck is recommended. The alignment of the device at the installation site should be performed by at least two people. Place the equipment on solid and flat subsurface only. Remove the packaging with care! Please follow the Installation manual to unpack the device. The device may only be used in premises that are installed according to national recognised standards. Locate the device in a way that the cutting unit from the power supply is easy to reach. The power cable serves as cutting unit. 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. Basically, the power cable cannot be replaced by inadequately sized power cable. The power connector may only be put into a grounded protection contact outlet. Operating the device in explosive areas is prohibited.

2.6

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!

2.7

Doors

The doors of the endoSTORE® vertical protect the endoscopes during the storage. The drying phase can only be started by closing the door. In 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 endoSTORE® vertical the doors can’t be opened simultaneously due to the opposing door lock.

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2.8

Air circulation

The drying of the endoscopes’ skin can be accelerated with the circulation of the air. Inside the endoSTORE® vertical is a blower in the Technology Department.

Warning! Do not grab into the fans! Protect fans and filters against splash water!

2.9

Warrantie

Within the warranty period defects of the device based on a material or manufacturing fault are eliminated gratuitously. Warranty adjustment shall not extend the warranty period or a new beginning of it. The manufacturer assumes no warranty in:  third-party intervention  removal/alteration of the serial number  changes or extensions that cause a defect  repair work, which was not carried out by service personnel authorized by ESCAD Medical GmbH Damages caused by improper usage or neglect of this operating manual are exempt from warranty claims. Also exempt are damages due to extraneous cause, in particular damages caused by electrical surge. Furthermore, the terms and conditions apply (more information: www.escad-medical.com).

2.10 Service, Repairs and Modifications The service interval is 12 months. In service cases please inform our service hotline: phone +49 (0) 7554 / 9999-500 fax +49 (0) 7554 / 9999-558 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 authorized by the manufacturer. Caution! ESCAD Medical does not assume liability for injuries or damages which result from repairs conducted by non-authorized staff.

2.11 Liability ESCAD Medical is only responsible for the effects on safety, reliability and functionality of the device if:  The assemblies, extension, readjustment, modifications or repairs are carried out by persons who are authorized by ESCAD Medical GmbH.  The electrical configuration of the premise is in compliance with the specification of the respective country. Operating Manual – endoSTORE® vertical

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

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

2.12 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.

2.13 Disposal The storage cabinet is categorized as an electric device. In accordance with Directive (European Union) 2002/96/EC 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 for the return and/or in your country available collection systems ESCAD Medical.

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3

Technical Manual

3.1

Versions

Different versions of the endoSTORE® vertical are available. In the two-sided version there is a door, a display and a bar code reader in addition on the back side. This pass-through version separates the hygiene (reprocessing) and the examination zone. The loading process of endoscopes will be carried out on the front side only. The unloading process can be performed on the front and back side of the endoSTORE® vertical.

3.2

Construction

connector for - power supply voltage - compressed air - LAN

on the back side of the two-sided version: - second door - touch display - bar code reader

control system with touch display, electronics-and pneumaticmodul

FlexFix Guide

glass door (not shown)

on-off switch

Barcode Scanner

rotation module

technique drawer

ventilation system

figure without door

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3.3

Operations of the endoSTORE® vertical

The storage cabinet has the following main functions: 



storage of endoscopes after reprocessing incl. drying function 

hanging storage for eight to twelve endoscopes



adaption via connector (optional equipment)



circulation of filtered air in all cannels of flexible endoscopes (e.g. biopsy, water, jet channel) of every manufacturer after reprocessing



circulation of filtered air in the interior space of the endoSTORE® vertical



control with up to three different air pressures



reduction of the air pressure reaching a minimum time of circulation



fault message management



optional: interface between reprocessing and operating room (two-sided version)

documentation and visualization of important information for the reprocessing room 

user via bar code reader



endoscope and storage yard via bar code reader



documentation of drying and storage time



recording and storage of all process data



warning in case of failure or exceeded storage time

 simple and safe operation

3.4



touch display



door lock with user authorization via bar code reader

Optional Operations

To enhance the functionality of the endoSTORE® vertical the following add-ons are available and can be purchased as an option: 

SMART Light The storage cabinet is equipped with LED light. The color changes according to the storage status of the endoscopes. green  storage phase blue  drying phase red  failure



SMART Connect In connection with a reprocessor: 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 section 6.16). 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 reprocessor can be imported by clicking (see section 6.7.2.2 and 6.8.2.2) or automatically at up to three times per day (see section 6.16).

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

HIS Interface The HIS add-on releases process and master data from the endoSTORE® 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 section 6.17).



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



Label Printer All relevant process data can be printed on a label printer after unloading an endoscope. The label printer is provided by ESCAD Medical GmbH. A network connection between endoSTORE® and label printer is required.



Sensors Critical parameters 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 endoSTORE®.



Multibox For endoscopes with less channel number it is possible to store more than two endoscopes on one wall. This add-on enables the storage and recording of up to twelve endoscopes in the cabinet.



Transfer After storing an endoscope in centralized endoSTORE® in the endoscopy area the storage process can be continued in a decentralized endoSTORE®. The process steps in the different storage locations can be recorded completely.

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4 Start of Operation 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 Supply

Use only a tested power cable for connecting the equipment to the power supply voltage. Pay attention to the correct power supply voltage. Connect the device only to a grounded electrical outlet. The power cable of the endoSTORE® serves as a cutting unit. If this is not easily accessible an appropriate device must be installed by the operator (for example a central emergency stop).

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4.2

Compressed Air Supply

A connection (inner diameter 6 mm) with quick connector establishes the compressed air supply to the endoSTORE®. The connection is allowed only to systems with filtered and compressed air (specifications see chapter 10).

Warning! Not following the manual might lead to disturbance in circulations of air!

power cable

Potential equalization plug

LAN cable

air connection, quick coupling

4.3

Network Connection

The storage cabinet can be integrated into the hospital network via LAN connection (two LAN connections in two-sided version). 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.

Reprocessor RDG-E

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5 Operation of the Unit 5.1

Switching On/Off

After connecting power supply, medical air and possible required LAN connection the device can be put into operation. Turn on the storage cabinet using the on/off switch on the front of the endoSTORE. The blue light within the switch lights up and the touch display shows various information (see chapter 3.2 and 5.2). 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

5.2

Information Screen

(In two-sided version: the same at front and back side) The control panel with integrated touch display regulates all processes and visualizes the operation. On the main screen the following information is displayed: storage yard number stored endoscopes with type bar code Drying time: hh:mm

status display - free - in progress - finished - warning

Statusweergave: 

free

= free storage yard



in progress

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



finished

= the set drying time has been reached



warning

= maximum storage time is exceeded or pressure malfunction during storage

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5.3

Bar Codes and Bar Code Reader

Bar codes are used to identify users, endoscopes and storage yards. These bar codes will be generated and delivered by ESCAD Medical GmbH. Bar codes for endoscopes and users must not be assigned twice. Make sure that all endoscopes are prepared with different bar codes and all users are registered in the device. The endoSTORE® vertical can be operated by authorized and registered staff only. Using the bar code reader the bar codes of users, endoscopes and storage yards bar codes can be read and entered to the system.

5.4

Process steps before storing an endoscope into the endoSTORE®

To ensure the drying of the inner channels and the outer surfaces of an endoscope in the endoSTORE® 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 connector (see User Manual according to the connector type)  Large amounts of residual moisture on the endoscopes surface should be removed.  To reduce residual moisture in inaccessible spots on the outer surface of the endoscope, the endoscope should be wiped of with a lint-free and highly-absorbent cloth before storing in the endoSTORE® (for example, between the steering wheels and on the contact surface). Wearing of disposable gloves is recommended.  The residual moisture in endoscope channels and on the outer surfaces should be less than 30 ml.

5.5

Endoscope loading (only possible on 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®! These increase the demand for compressed air!

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Procedural method: 1. user logs in via bar code reader 2. open the door

3. hanging endoscope at the free holder

4. connect connector

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Warning! To achieve a perfect drying result, make absolutely sure that all connections are correctly connected.

5. position FlexFix

6. scan the bar code of the endoscope which has been loaded

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7. scan storage yard bar code

8. „Scan the next endoscope or close the door“ is displayed

Case 9a. Scan the next endoscope

 loading: repeat steps 3 to 8  unloading: see section 5.9

Case 9b. If Cancel or close door

 system starts the drying process  the storage time begins

10. The information screen displays the storage yards and loaded endoscopes with its type and storage status. More information see chapter 5.2.

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5.6

Endoscope Loading with active SMART Connect-add-on (optional)

This function can be activated by an additional license key for the SMART Connect-add-on for the endoSTORE® vertical (see section 3.4 and 6.16). This add-on works in connection with a RDG-E (List available on request). The SMART Connect add-on not only includes the master data transfer (saved user and endoscope information), but also the security query: By inserting an endoscope, the endoSTORE® checks, whether this has been processed correctly in an adjustable time window in the RDG-E. Procedural method: 1. user logs in via bar code reader 2. open the door 3. scan the bar code of the endoscope which has been loaded

4. Database request to RDG-E runs

The database request can yield three different results, which are described below: case 5a. Endoscope passed a correct reprocessing cycle up to 30 minutes1 before:

1

The maximum time between reprocessing and storage of an endoscope can be set (see section 6.16).

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