Models ESC5T, ESC10T, ESCENT & ESCTPC Operators Manual Issue 12 July 2014

CE Marking certifies that this equipment conforms to the following EEC directives: Low Voltage Equipment – 72/23/EEC & 93/68 EEC Electromagnetic Compatibility – 89/336/EEC

Certificate No. 0954499

CONTENTS CONTENTS ... 3 1) INSTALLATION: ... 5 2) INTRODUCTION:...6 FIND YOUR WAY AROUND ESC ... 6 ENDOSCOPE STORAGE CABINET (ESC) DESCRIPTION... 7 AIR FILTRATION ... 7 DESICCANT ... 7 TRACE ABILITY... 7

3) LAYOUT: ... 8 ESC CONTROL PANEL ... 8 KEY OPERATED DOOR OVERRIDE. ... 8 MASTER SWITCH ... 8 LIGHTS... 8 AIFLOW MONITORING... 8

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

5) ENDOSCOPE HANGING SYSTEM:... 11 HANGING THE ENDOSCOPES ... 11 CHANNEL VENTILATION ... 11 CHANNEL CONNECTOR MANIFOLD ... 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 SET TIME ... 26

8) ALARMS: ... 28 AUDIBLE ALARMS ... 28 SCREEN WARNINGS ... 28

9) PRINTER FUNCTIONS:... 30 LABEL PRINTOUT – LOAD SCOPE ... 30 LABEL PRINTOUT – UN-LOAD SCOPE ... 30 LABEL PRINTOUT – UN-LOAD SCOPE OUT OF TIME ... 31 LABEL PRINTOUT – AUTOMATIC SCOPE OUT OF TIME... 31 LABEL PRINTOUT – START UP HOOK STATUS ...32

10)

CARE & MAINTENANCE OF YOUR ESC: ... 33

DAILY MAINTENANCE: ...33 WEEKLY / MONTHLY MAINTENANCE: ...33 SERVICE ...33 PRE-FILTER ...33 MAIN FILTER ...33 TESTING OF THE MAIN FILTER. ...33 AIRFLOW – AIR CHANGES IN THE CABINET ... 34 CHANNEL VENTILATION ... 34 SERVICING ... 34

11) ROUTINE MAINTENANCE ... 35 FILTERS ... 35 LOW AIRFLOW ALARM ... 35 FAN ... 36 ENCLOSURE ... 36 CONSUMABLES: ... 36

12) FAULT FINDING... 37 13)

FILTERS: ... 38

PARTICULATE PRE FILTER... 38 HEPA FILTER ... 38 EXHAUST FILTERS ... 39

14) ENDOSCOPE CLEAN AIR SYSTEM: ... 40 15) DRIP MATS ... 41 16) VALIDATION ... 42

Endoscope Storage Cabinet

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Operators Manual

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, main filter and desiccant columns 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 ESC The diagram below shows the different elements of the ESC. 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)

Printer Door Override Fan Filter Housing Dessiccant Holder Scope Storage Hour Counter

1

4

2

5 11

13

6

3 7

8

9 10

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ENDOSCOPE STORAGE CABINET (ESC) DESCRIPTION The Endoscope storage cabinet has been designed to provide a fully validated endoscope storage cycle. The ESC retains data and maintains a record of the clean life cycle of the endoscope and when used in conjunction with the ISIS automated Endoscope Re-processor can give a record of the reprocessing and storage conditions. With or without using an ISIS AER the ESC maintains a record of the time the endoscope has been stored and provides data on the stored time, with a 72 hour or 31 day (depends on model purchased) cut off for a useable clean stored endoscope. The ESC5T and ESC10T cabinets are fitted with a lumen irrigation system and are used to store endoscopes with up to 7 lumens. The ESCENT cabinet is designed specifically to store ENT endoscopes which have no lumens. This cabinet is the size of the ESC5 but can hold 10 of the small ENT endoscopes. The ESCTPC cabinet is designed to hold 5 TOE endoscopes that also have no lumens.

AIR FILTRATION The ESC has HEPA filtered air blowing over the endoscopes to help maintain a biological clean environment.

DESICCANT The ESC is also equipped with desiccant filters to help maintain a moist free atmosphere through the lumens of the endoscope. This low level of moisture is essential to maintain the cleanliness in the lumens of the endoscope and ensure the correct storage criteria. NOTE: If the 6 monthly services are not carried out on time and the desiccant column changed, the 72 hour or 31 day validity of the cabinet cannot be verified and the endoscopes may be unsafe to use directly from the cabinet for patient use.

TRACE ABILITY The ESC records the date and time of any scope that is loaded, and also the position that it is to be housed in. This information is utilised when the scope is removed, to verify the length of time that the scope has been stored. In addition to this, there are also hours counters on each stored position to provide a visual indication of how long a scope has been stored inside the ESC.

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

KEY OPERATED DOOR OVERRIDE. To access the ESC 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. The Key is shown here 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 shown here on the Right Hand Side

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

AIFLOW MONITORING When the ESC 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.

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Endoscope Storage Cabinet

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4) OPERATOR - M/C INTERFACE CONTROLS INTERFACE To use the ESC, 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 ESC, 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 ESC, to which the TAG’s need to be placed so that the ESC computer can read the data, and present it to the screen.

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

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Endoscope Storage Cabinet

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Operators Manual

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 (not applicable to the ESCENT & ESCTPC models)

When the endoscope is in place, the air system to ventilate the lumens is connected via the CPC fitting and tubing, to the manifold behind the head of the endoscope for all the channels on the endoscope. 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 manifold. Lift the endoscope up and out of the holder groove.

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CHANNEL CONNECTOR MANIFOLD

Air connection to pump supply Lumen Connection: Tubing Identification Yellow – Air Green – Aux Water Clear – Suction Red – Aux Air Blue – Water Purple – Raiser Bridge Orange - Biopsy

How to use the channel ventilation manifold: 1. Place the manifold on the top of the scope hanger bracket. 2. Connect the umbilical tube to the air supply CPC coupling 3. Connect the colour coded tubes to the corresponding channels to suit the scope being dried / stored. 4. Blank off any unused colour coded tubes to prevent air by pass using the plastic plugs provided.

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Endoscope Storage Cabinet

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Operators Manual

USING THE CONTROL PANEL:

HOW TO LOG ON If the computer screen on the front of the ESC is blank when you approach it, you need to touch the screen to energise it. Screen 1 ESC 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.

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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 ESC 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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Endoscope Storage Cabinet

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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 Press OK (not applicable to the ESCENT and ESCTPS cabinets)

Screen 10 The doors must be closed to allow the ESC 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 NB: the boxes across the bottom of the screen indicated which hook should have a scope in position.

Screen 1 ESC Home Page This screen will go blank after 15 minutes (to save energy). Tap the screen to re-activate.

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Endoscope Storage Cabinet

Operators Manual

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

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

Screen 12 Select if you want to add a patients name or reference Number to the use of this scope

Screen 8 Type in the patient name

Enter Patients ID

This keyboard can be used to enter both alpha and numeric symbols. Pressing “Num” gains access to the number keypad. When data has been entered correctly Press OK Screen 13 Select door to be opened to access scope. Door will release. Disconnect the scope and lift off the hook. Remove the scope from the cabinet.

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Endoscope Storage Cabinet

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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 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

Screen 10 Close the doors. The doors must be closed to allow the ESC 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. When the scope is removed the tick in the corresponding location box on the bottom of the screen should vanish. If this tick remains after the scope has been removed, please refer to the Hook status section, later in this chapter. Screen 5 Main menu screen - Select “Logout” to return to home page. The Home page screen will go blank after 15 minutes (to save energy). Tap the screen to reactivate. NB: Hooks with scopes. 17

Endoscope Storage Cabinet

Operators Manual

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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Endoscope Storage Cabinet

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JANE DOE

Screen 8 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

Screen 18

JANE DOE 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 .

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Endoscope Storage Cabinet

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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’ . 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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