Model EDC10T Operators Manual Issue 5 July 2014

CE Marking certifies that this equipment conforms to the following EEC directives: MDD 93/42/EEC amended by 2007/47/EC LVD 2006/95/EC EMC 2004/108/EC WEEE 2002/42/EC

Certificate No. 0954499

Contents 1) INSTALLATION: ... 5 2) INTRODUCTION:...6 FIND YOUR WAY AROUND EDC ... 6 ENDOSCOPE DRYING CABINET (EDC) DESCRIPTION ... 6 TECHNICAL SPECIFICATION ... 7 AIR FILTRATION ... 7 LUMEN AIR PURGE ... 7 TRACE ABILITY... 7

3) LAYOUT: ... 8 EDC CONTROL PANEL ... 8 KEY OPERATED DOOR OVERRIDE. ... 8 MASTER SWITCH ... 8 LIGHTS... 8 AIFLOW MONITORING... 8 CABINET PRESSURE - MAGNAHELIC GAUGE ... 8 CONDENSATE DRIP TRAY ... 9

4) OPERATOR - M/C INTERFACE ...9 CONTROLS INTERFACE ... 9 PERSONAL IDENTIFICATION NUMBERS (PIN) ... 9 OPERATOR ID TAG ... 9 SCOPE ID TAG ...10 TAG READER ...10 DATA PRINT OUTS...10 PRINT OUT HANGERS ...10

5) ENDOSCOPE HANGING SYSTEM:... 11 HANGING THE ENDOSCOPES ... 11 CHANNEL VENTILATION ... 11 MULTIWAY CHANNEL CONNECTOR ... 12

6) USING THE CONTROL PANEL: ...13 HOW TO LOG ON... 13 HOW TO LOAD A SCOPE ... 14 HOW TO REMOVE A SCOPE ... 16

7)

MANAGING THE SYSTEM (ADMINISTRATION): ... 18 LOGGING ONTO ADMIN MENU ...18 ADD A USER ...18 EDIT A USER ...20 ADD A SCOPE... 21 EDIT A SCOPE ...22 HOOK STATUS ...23 DATA RETRIEVAL ...25 OPEN DOOR... 26 SHUTDOWN ...27 AUDIBLE ALARMS ... 28 SCREEN WARNINGS ... 28

9) PRINTER FUNCTIONS:... 29 LABEL PRINTOUT – LOAD SCOPE ... 29 LABEL PRINTOUT – UN-LOAD SCOPE ... 29 LABEL PRINTOUT – UN-LOAD SCOPE OUT OF TIME ... 30 LABEL PRINTOUT – AUTOMATIC SCOPE OUT OF TIME... 30 LABEL PRINTOUT – START UP HOOK STATUS ... 31

IMS SYSTEM...31 10)

CARE & MAINTENANCE OF YOUR EDC: ...32

DAILY MAINTENANCE: ...32 WEEKLY / MONTHLY MAINTENANCE: ...32 SERVICE ...32 MAIN FILTER ...32 TESTING OF THE MAIN FILTER. ...32 AIRFLOW – AIR CHANGES IN THE CABINET ...32 POSITIVE PRESSURE ...33 CHANNEL VENTILATION ...33 SERVICING ...33

11) ROUTINE MAINTENANCE ... 34 FILTERS ... 34 LOW AIRFLOW ALARM ... 34 FAN ... 35 ENCLOSURE ... 35 CONSUMABLES: ... 35

12) FAULT FINDING... 36 13)

FILTERS: ... 37

HEPA FILTER ...37

14) DRIP MATS ... 38 15) VALIDATION ... 39

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INSTALLATION:

The machine will be supplied ready assembled and with a correctly fused mains 3 pin plug fitted. The filters and pre-filter will be fitted into the unit at Cantel Medical, (Plug Fuse is 3A). The units have wheels/feet fitted in each corner of the base section. For ease of installation and positioning the units are delivered with the wheels in the down position. Tether Strap As the unit is tall and slim, it is possible that if the unit is pulled forward when the feet are down, the unit could be topple forward. A restraining tether strap is provided on the rear of the unit . Push the unit in to its final position and then ease the unit from the wall to allow free end of the tether strap to be fixed to the wall.

Lever to change the direction of movement

Ratchet lever (pushes in when not required)

Levelling Once the unit is in its final position the feet should be put down which takes the wheels off the floor, stabilises the unit and allows the unit to be levelled. On each wheel fitting is a small ratchet lever. Pull this out from the wheel, move the lever sideways to move the ratchet and lower the foot into position. Ensure the wheel is off the floor and then with a spirit level placed inside the unit, use the extra movement off the feet (approx 10mm) to level the unit as far as possible. Where units are installed side by side it may only be possible to lower and level the front two feet. There is a lever above the pullout section on the wheel that reverses the movement of the ratchet The cabinets are tested at Cantel Medical and a test certificate supplied. Since damage could occur in transportation, the cabinet filters should be checked before use ie. the pre-filter and main filter are in the correct positions. The cabinet should be checked before use for airflow and efficiency of filter seal. Once unit is tethered and levelled, plug in the mains plug to a 13 amp socket

IMPORTANT THE APPLIANCE MUST BE CORRECTLY EARTHED. THE CABINET USES THE EARTH IN A NORMAL 13amp SOCKET.

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2) INTRODUCTION: FIND YOUR WAY AROUND EDC The diagram below shows the different elements of the EDC. 1) 2) 3) 4) 5) 6) 7) 8)

Mains on/off switch Airflow indicator Light Switch Testing port Magnehelic Gauge Access door Control panel Tag Reader

9) 10) 11) 12) 13) 14)

Printer Door Override Fan Filter Housing Scope Storage Hour Counter Printout hanger Condensate drip tray

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1

5

2 3

4 12

7

13

8 9

6 10

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ENDOSCOPE DRYING CABINET (EDC) DESCRIPTION The Endoscope drying cabinet has been designed to provide a fully validated endoscope drying and/or storage cycle. The EDC retains data and maintains a record of the drying and clean life cycle of the endoscope and when used in conjunction with the ISIS automated Endoscope Reprocessor can give a record of the reprocessing, drying and storage conditions. 6

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With or without using an ISIS AER the EDC maintains a record of the time the endoscope has been stored and provides data on the stored time, with a settable storage time from 72 hour up to 31 days for a useable clean stored endoscope.

TECHNICAL SPECIFICATION Dimensions Construction Airflow Filtration Lumen Airflow Scope Storage Monitoring

Audible Lighting Security Traceability Usability Connectors

1300mm wide x 610mm deep x 2040mm high Carcass - Epoxy coated 316-Stainless Steel Clean airflow through cabinet producing >100 air changes per hour HEPA Filter - 99.997% efficient to 0.3µ particle Sequential Airflow through each channel constantly monitored Microbial levels of each processed endoscope will be maintained for 31 Days Audible and Visible Low Airflow Alarm for HEPA Filter Blockage Audible and Visible low airflow/blocked channel alarm for lumen patency Individual scope storage times constantly displayed Door Alarm Internal Lights can be switched off if required (2 x 15W) Access to locked cabinet via tag reader Scope Tag Reader/2 x Scope Printouts Touch Screen Each scope connected via a connector block with individual connections for each lumen channel

AIR FILTRATION The EDC has HEPA filtered air blowing over the endoscopes to help maintain a biologically clean storage environment. 90% of the air in the cabinet is recirculated through the HEPA filter when the doors are closed, allowing a small positive pressure to be maintained and the humidity to be controlled to below 30%.

LUMEN AIR PURGE The EDC is equipped with a special drying system that produces clean, very low humidity, Hepa filtered air that passes through the lumens of the endoscope drying any residual moisture remaining after reprocessing in the AER. This drying process is essential to maintain the cleanliness in the lumens of the endoscope and ensure the correct long term storage criteria. NOTE: If the 6 monthly services are not carried out on time and the dry air system not maintained, the validity of the cabinet cannot be verified and the endoscopes may be unsafe to use directly from the cabinet for patient use.

TRACEABILITY The EDC records the date and time of any scope that is loaded, the position that it is stored in, and the airflow and humidity of the air passing through the endoscope. This information is utilised when the scope is removed, to verify the storage conditions and the length of time that the scope has been stored. In addition to this, there are also hour counters on each stored position to provide a visual indication of how long a scope has been stored inside the EDC. 7

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3) LAYOUT: EDC CONTROL PANEL The control panel on the front of the EDC houses the following items: Touch screen, tag reader, printer,

KEY OPERATED DOOR OVERRIDE. To access the EDC you need to use the touch screen to unlock the doors. However if there is a problem, ie power cut etc: then the doors can be unlocked with the Key lock on the centre panel.

MASTER SWITCH Mains On/ OFF: The fan, lights and pumps are started by switching on the rocker switch. The switch is illuminated to indicate ON status. The switch is on the Right Hand Side.

LIGHTS The lights can be switched off by using the switch.

AIFLOW MONITORING When the EDC is on, the airflow through the HEPA filter is indicated by the RED / GREEN lights. Shown here on the Switch Panel. The monitoring panel shows the status of the airflow through the unit and thus the status of both the pre-filter and the main HEPA filter, with an alarm which is both visual and audible. If the warning light is flickering, or remains on constantly, this can indicate that the filters require attention or possibly the alarm need re-calibrating. Please refer to the section on Maintenance. The alarm can be muted by pressing the mute button, but if no further action is taken, the audible alarm will restart. The condition of the filter and the airflow must be checked at routine intervals.

CABINET PRESSURE - MAGNAHELIC GAUGE The internal pressure inside the cabinet is displayed on the magnahelic gauge mounted on the top left hand side of the cabinet. This pressure should always be positive up to 20pa to ensure the cleanliness of the air within the cabinet.

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CONDENSATE DRIP TRAY There is a condensate drip tray in the base of the cabinet to collect the small amount of water produced by drying the air that flows through the lumens. The tray should be inspected daily and emptied as necessary. The tray is removed by gently pulling the handle forward until the tray is free of the cabinet. To replace the tray, insert the tray in the recess and slide back until the front is level with the front of the unit.

4) OPERATOR - M/C INTERFACE CONTROLS INTERFACE To use the EDC, the user needs to follow the instructions on the touch screen. A step by step guide is detailed elsewhere in this manual. To operate the touch screen, press on the indicated part of the screen, with a light to normal force.

PERSONAL IDENTIFICATION NUMBERS (PIN) Each user will need a four digit PIN when their details are loaded onto the computer system. If you forget your PIN, a new one can be assigned under the edit user function.

OPERATOR ID TAG To avoid having to type in your PIN and ID number every time you use the EDC, a TAG can be used. This TAG stores all the data about a particular user, and as such should not be shared with anybody else. If a tag is lost or stolen, the user needs to be deactivated, and a new user ID assigned with a new TAG.

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SCOPE ID TAG

Each scope has a list of ID criteria, which is stored on a TAG with an IP68 rating If the TAG is removed from the scope, you must re-TAG the scope using the Add Scope feature.

TAG READER The TAG reader is the device on the front of the EDC, to which the TAG’s need to be placed so that the EDC computer can read the data, and present it to the screen.

DATA PRINT OUTS There is a printer on the front of the EDC, which will provide a print out record each time an endoscope is loaded or unloaded from the EDC.

PRINT OUT HANGERS There is a hanging bar on the front of each door where the ‘Scope In’ printout for the endoscope can be placed until it is removed from the cabinet.

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ENDOSCOPE HANGING SYSTEM:

HANGING THE ENDOSCOPES The endoscopes are supported at both the head, and the light source ends of the endoscope. The endoscope head is supported on the top hanging rail. The head is raised above the shaped holder, the insertion tube slid into the groove, and then the head is allowed to gently move downwards, until the head is resting in the holder groove. The light source end of the endoscope is supported on the lower hanging rail, and again the end is raised above the holder groove, the tube slid into the groove, and then the end is gently lowered down until it is resting in the holder groove.

CHANNEL VENTILATION When the endoscope is in place, the air system to ventilate the channel lumens is connected via the multiway connector and tubing situated behind the head of the endoscope. The air flows through one lumen at a time, ensuring each lumen is purged fully. A valve block sequences the airflow through the six channels. When removing an endoscope from the storage cabinet, disconnect the connectors from the endoscope, and gently allow them to drop down and hang from the multiway connector. Lift the endoscope up and out of the holder groove.

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MULTIWAY CHANNEL CONNECTOR

Quick Release Control Lumen Connection: Tubing Identification Airflow Channel Number Yellow – Air

Channel 1

Red – Aux Air Channel 2 Blue – Water

Channel 3

Green – Aux Water Ch. 4 Clear – Suction Channel 5 Orange – Biopsy Channel 6

How to use the multiway channel connector: 1. Connect the multiway connector to the air supply connection behind the head of the endoscope to be connected. 2. Connect the colour coded tubes to the corresponding channels to suit the scope being dried / stored. 3. Any unused colour coded tubes can be shortened or removed. They must NOT be capped off. 4. Airflow is pumped through one channel at a time, sequencing through the six channels in the order listed above. NOTE: All accessories used with the cabinet, and to connect the endoscopes must comply to Cantel Medical’s specification.

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USING THE CONTROL PANEL:

HOW TO LOG ON If the computer screen on the front of the EDC is blank when you approach it, you need to touch the screen to energise it. Screen 1 EDC Home Page – Indication on screen of hangers being used and confirmation of airflow in these hangers Present the operator TAG to the TAG reader. If a TAG is used, then go to screen 5 (Main Menu) If the manual log in is used, ‘Press Here’ and follow screens 2 – 3 - 4 Screen 2 Touch the white box (data field) to enter your PIN or ID number

Screen 3 Type in your user 4 digit ID number or your 4 digit PIN, dependant on which white box “field” you selected.

008

****

Screen 4

0

Once you have input your data, press Login Return will take you back one stage at a time.

NB: There is an instruction box on the bottom of all the screens, which informs the user what data or action is required. 13

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HOW TO LOAD A SCOPE Screen 5 Main Menu Page Once you have logged in or presented your TAG, you will be presented with the main menu page. Operators name is displayed in the bottom box. Now select what you want to do. In this example – Press “Scope In” NB: “user” access rights, will not allow the operator to select “Admin”

Screen 6 Select and Press which hook number the scope is to be placed on, and then press OK.

Screen 7 Present the scope TAG to the TAG reader to identify the scope data to the EDC computer. Press OK and Door will release. If no tag – Press ‘Serial number’

Screen 8 Enter Serial number using the keypad. Press Num key for the numeric keypad. When data entered press OK, screen will return to above with serial number recorded, Press OK and Door will release.

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Screen 9 This screen will confirm the hook number to place the scope. Once you have connected all the air supply fittings and ensured the centre separators are fitted. Press OK

Screen 10 The doors must be closed to allow the EDC to process any further commands. The audible buzzer will not switch off until the doors are closed and locked

Screen 11 This screen allows selection of a printout confirming the details of the loaded endoscope

Screen 5 Main Menu Log out to return to the Home Screen 1 This screen will go back to the home page after 1 minute if no further process is selected.

Screen 1 EDC Home Page The status for the hook where the endoscope has been located will turn green to show the hook is in use.

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HOW TO REMOVE A SCOPE Screen 1 Present TAG or Press to log on manually.

Screen 5 Main Menu Select Scope Out

Screen 14 Identify scope to be removed by either Presenting the Tag to the tag reader or Selecting the hook in the list or Tap the serial number, enter the number on the keypad Screen and press OK. The door will be released to access the endoscope. If further details of which scope to remove are required Select scope hook and Press ‘Details’ Screen 15 Details of the scope stored are displayed as shown. Press OK to close dialogue box. Press OK or Cancel depending whether the scope is to be removed.

Screen 16 Confirmation of scope removed. Select Yes to confirm

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Screen 10 Close the doors. The doors must be closed to allow the EDC to process any further commands The audible buzzer will not switch off until the doors are closed and locked When the doors are closed, a print out will follow. Screen 5 Main menu screen - Select “Logout” to return to home page. The main menu screen will go Home page screen automatically after 1 minute.

When the scope is removed the green colour in the corresponding location box in the centre of the screen should change back to grey. If the location box remains green after the scope has been removed, please refer to the Hook status section, later in this chapter.

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7) MANAGING THE SYSTEM (ADMINISTRATION): LOGGING ONTO ADMIN MENU Screen 1 Present TAG or Press to log on manually as previous.

Screen 5 Main Menu Select Admin NB: the boxes across the bottom of the screen indicated which station should have a scope in position.

Screen 17 Admin Menu

ADD A USER From the Admin Menu Select ‘Add User’ Screen 18 Add User Fill in the blank fields by the following steps. The next ID number is automatically selected. First present the new TAG to the reader Then touch the name field Present the TAG to input the TAG data. The operator ID is automatically assigned by the computer in a sequential order.

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Screen 8

JANE DOE

Type in the name of the new user. Then press OK Enter User Name

Return will take you back one step.

Screen 18

JANE DOE

Now select the PIN field by touching the white box

Screen 3 Enter a four digit number Then press OK

JANE DOE

Screen 18

RM2C0415D7AA6E2 √

****

Select what “Access Rights” the new user is to have. “User” only allows the new user to load and un-load endoscopes. “Admin” allows the user access to select and edit user’s and scopes.

The user will remain Inactive until “Active” is selected When the data is correct, Activate the user by pressing the “STATUS” field. Press ‘ SAVE’ to store data, this will then return screen to the Admin Menu page If there are no further requirements in the Admin section, select ‘Return’ and then on main menu screen logout . If no action is taken for approx. 1 minute the control panel automatically returns to the Home Page screen.

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EDIT A USER To edit a user, this can be used to change the access levels as above, either giving more or less access rights, or removing access rights to de-activate a user; or can be used to reallocate a tag to a new user or change a PIN number. NB: when a USER leaves the department, their access rights should be deactivated. A user can be deleted but this change should be documented. A deleted user list is kept on the machine. Log On and select Admin to get to the Admin menu as previous section. Screen 17 Admin Menu Select ‘Edit User’

Screen 19 Select a name from the list of users In this example “Test User” Or present the user TAG which will highlight the person assigned to it. Press Edit to continue and make changes. Delete to remove the user from the list Quit to go back to administration menu. Screen 18 - on selecting Edit above Select the detail to be change by touching the relevant white field. Change:1) Access Rights (add or remove Admin / User) 2) Status (Active or Inactive) 3) PIN 4) Change Name Press “Save” to register changes. Press “Quit” to stop at any time and return to previous screen ‘ Save’ or ‘Quit’ is selected, this will then return screen to the Admin Menu page If there are no further requirements in the Admin section, select ‘Return’ and then on main menu screen ‘Logout’. If no action is taken for approx. 1 minute the control panel automatically returns to the Home Page screen. NB. It is not possible to assign a new tag to a user if they lose their tag. The user will have to be deleted and then set up as a new user with a new tag.

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