RAPIDAER Operators Manual Issue 01 Sept 2014

RapidAER

Operators Manual – RA015

Language Version Original Instructions in English.

0088 CE Marking certifies that this equipment conforms to the following EEC directives: Medical device directive 93/42/EEC Low Voltage Equipment – 72/23/EEC CE marking directive 93/68 EEC Electromagnetic Compatibility – 89/336/EEC

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CONTENTS INTRODUCTION: ... 6 RAPIDAER DESCRIPTION:...6 Process Cycle ... 6

UNDERSTANDING RAPIDAER: ... 7 PASS THROUGH TECHNOLOGY: ... 7 TRACE ABILITY:... 7 FIND YOUR WAY AROUND RAPIDAER: ... 8 “Dirty Side” Scope loading side ... 8 “Clean Side” Scope Un-loading side ... 8 On/ Off switches: ... 9 Emergency STOP button: (clean side only) ... 9 TAG reader:... 9 Chemical chamber: ... 9

RAPIDAER CONNECTIONS:...9 Electrical connections: ... 9 Supply water:...10 Waste water: ...10 Air Purge Supply: ...10 Connection Diagram ...10 Specification ... 11 Operator - RAPIDAER interface... 12

RAPIDAER CONTROL PANELS: ...13 Dirty Side (Load Side) control touch screen ... 13 Clean Side (un-Load side) control Panel ... 13

OPERATOR ID... 14 Personal Identification Number ... 14 (PIN) ... 14 Operator ID TAG: ...15 Scope / Connection Manifold ID TAG: ...15

PRE-LOADING A SCOPE:... 16 Preparing the scope basket: ... 16 Connection Manifold... Error! Bookmark not defined. Loading the Scope into the RAPIDAER machine ... 17 Un-Loading a scope from the RAPIDAER machine: ... 17

HOW TO “LOG ON” RAPIDAER ... 18 AUTOMATIC RE-PROCESS CYCLE ... 20 Cycle Sequence ... 21 Scope Load Sequence... 21 Wash Cycle Sequence ... 21 Scope Unload Sequence ... 21

USING THE RAPIDAER MACHINE...22 Switching the RAPIDAER Machine ON. ...22

USING THE RAPIDAER MACHINE – RUNNING A CYCLE: ...23

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SCOPE PASS UNLOAD PROCESS ... 25 SCOPE FAIL UNLOAD PROCESS... 26 OPTIONS MENU...27 Self Disinfect:...27 Opening Doors: ... 28 Retrieving a Scope:... 28 Opening the Chemical Storage Drawer: ... 29 Activate Flush System routine: ... 30 Water Sample ... 30 Engineering. ... 30 Leak Test: ... 30 Set Time ... 31 Print Cycle Ticket ... 31 Print SD Ticket ... 31 Hospital Protocols ... 31 Add a New User ...32 EDIT an existing User’s details ...33 Assign a NEW scope ID ... 34 EDIT an existing scope ID ... 38 Copy Files ... 39 Log Files... 41 Print Cycle Report... 41 Print Last Cycle Ticket ... 41 Print SD Ticket ... 41

AUDIBLE ALARMS ...41 Information alarm: ... 41 Warning Alarms: ... 41 Power interruption: ... 41 Remote alarms: ... 42 DATA Systems ... 43 DATA Storage: ... 44

PRINTOUTS ... 45 Changing Printer Paper: ... 47

ESSENTIAL OPERATING PRACTICES. ...51 Hospital Protocols: ...51 Disinfectant Warnings: ...52 Disinfectant Types: ... 53

DISINFECTION OF SCOPES: ... 54 Connection of Endoscopes to Irrigation Channels: ... 54 Endoscope Storage After Disinfection Process ... 54 EU Regulations: ... 55 Biological Hazards: ... 55 Training: ... 55 Validation: ... 55 Compliance:... 55 Declaration of Conformity ... 56 “Peracetic Acid” spillage...57

CONSUMABLES: ...58 GENERAL CARE: ... 59 ACTIVATED CARBON AIR FILTRATION... 59

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ROUTINE MAINTENANCE: ... 60 MACHINE SELF DISINFECTION:... 61 Chemical Storage Drawer: ... 62 Changing Chemicals: ... 62

DOOR LOCK – MANUAL OVERRIDE: ... 63 WATER SAMPLE PROTOCOL... 64 Where to find the water sampling port. ... 65

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Operators Manual – RA015

INTRODUCTION: RAPIDAER DESCRIPTION: The Medivators® range of automated endoscope re-processors, cover a wide range of capabilities to suit your particular requirements. RAPIDAER is the latest in the range, which now offers the user full pass through compliance to meet the requirements of BS EN 15883 Parts 1 & 4, SHTM2030 & CFPP01-06. The RAPIDAER is a single chamber machine processing a single multiple channel endoscope per cycle in an easy to load basket. The machine has the same unparalleled external scope cleaning performance and integral individual channel cleaning facility as the Autoscope Isis providing a fully compliant re-processing performance. Included in the automated wash cycle time of approx.17 minutes, is the automated leak test facility, and continuous channel monitoring. DATA records include operator, endoscope, and wash cycle information, together with the unique identification of the connection manifold being cross referenced against the endoscope channels of the endoscope.

PROCESS CYCLE The normal re-processing cycle is in 7 stages.

1. 2. 3. 4. 5. 6. 7.

Leak Test Gross Wash and lumen patency check Detergent wash Detergent Rinse, Disinfectant Clean, Disinfectant Rinse. Air flush

The operator also has the option to perform a “Manual Leak Test” with the door open, prior to the wash cycle

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Operators Manual – RA015

UNDERSTANDING RAPIDAER: RAPIDAER is a fully compliant self contained pass-through endoscope reprocessing machine. Designed to re-process one endoscope in each cycle, RAPIDAER offers a full cycle process with-in 17 - 18 minutes of pressing the start button. (subject to a 5 minute disinfectant contact time and the incoming water temperature) Likewise loading the scopes is quick and efficient, by the use of the scope carrier basket design. Scopes can pre-loaded into their carrier baskets ready to be loaded in to the RAPIDAER machine, as soon as the re-processed scope is removed.

PASS THROUGH TECHNOLOGY: RAPIDAER offers a compact footprint design that can be easily delivered and installed with access through standard size doorways. The pass through function of RAPIDAER allows the owner to split the re-processing task into separate areas, either in the same room, or separate rooms, by incorporating RAPIDAER into a dividing wall. “Dirty Side” for loading used scopes & un-loading scopes that don’t complete their re-processing cycle. “Clean Side” for unloading re-processed scopes only.

TRACE ABILITY: RAPIDAER incorporates all the information that you require: Operators have to log onto the machine, by use of a Tag, or ID & PIN for both loading & un-loading The connection manifold and the endoscopes have to be logged onto the machine by use of a Tag, which identifies the channel configuration for irrigation and checks the hub and the manifold have the same channel connections. Any access to the user configuration and set-up options, requires a log in, either by use of a TAG, or “ID & PIN”. All information is captured in the RAPIDAER computer memory, and can be transferred when required via a USB data storage device, or the unit can be linked directly to a traceability system. A printout is produced as part of each cycle, with the option for a comprehensive print out:- detailed report.

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FIND YOUR WAY AROUND RAPIDAER: “DIRTY SIDE” SCOPE LOADING SIDE 11.. ON / OFF switches 22.. Printer (optional on this side) 33.. Process Chamber 44.. Tag Reader 55.. Control Panel touch screen (onboard computer) 66.. Chemical storage chamber

5 1 3 4

2 6

“CLEAN SIDE” SCOPE UN-LOADING SIDE The clean side has Emergency stop Button Printer Access to Process Chamber Tag Reader Control Panel Read out for cycle status

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ON/ OFF SWITCHES: The On/Off switches are located on the top left of the load side (dirty side) of the RAPIDAER adjacent to the control panel. GREEN is ON RED is OFF

EMERGENCY STOP BUTTON: (CLEAN SIDE ONLY) There is an emergency stop button on the top left of the unload side (clean side) of RAPIDAER.

TAG READER: The TAG readers are on both sides of the RAPIDAER machine, and are positioned to give the best possible ergonomic interaction with the operator and scope carrier baskets during loading and unloading.

CHEMICAL CHAMBER: The Chemical chamber is on the Dirty Scope, load side of the machine.

RAPIDAER CONNECTIONS: ELECTRICAL CONNECTIONS: RAPIDAER will be connected to a 32 amp, 50Hz, 240 V single phase supply. The connection point for each RAPIDAER machine should have an isolator switch located close to one side of the RAPIDAER machine, (pass through installations) If an engineer is working on the RAPIDAER machined he may require to disconnect the power supply and lock this isolator for health and safety requirements. 9

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Operators Manual – RA015

SUPPLY WATER: The incoming water supply to the RAPIDAER should be from an RO plant. The RO is connected to the machine at the top where there is an aseptic sampling point and isolation tap. The machine will use 44 litres per cycle.

WASTE WATER: Waste water from the RAPIDAER should flow directly to a standard vented drain. Always ensure that the water supply is turn on before using the RAPIDAER machine.

AIR PURGE SUPPLY: A medical grade air supply should be connected to the top of the machine with an line gauge to allow operators to see the air pressure that is being supplied.

CONNECTION DIAGRAM

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SPECIFICATION

Model

RapidAER

Dimensions Processing Time

Noise Level Weight Process Capacity

600mm (w) x 800mm (d) x 1930mm (h) 17 minutes Rapicide PA two part, single shot, Peracetic acid based disinfectant Mediclean Plus alkaline single shot detergent 230v, 50hz, 32 amp supply Protective Earth required IEC 60309 industrial coupler 64 litres per processed scope Steel frame, Polycarbonate doors, Plastic cover panels. <58 dBA 240Kg 1 large flexible endoscope per cycle

Enviromental Operation Conditions Operating Temperature Range Humidity

Ambient (0-40°C) 20%- 90%

Disinfectant Detergent Power Requirements Class 1 equipment Connection to supply Water Requirements Construction

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OPERATOR - RAPIDAER INTERFACE NOTE: Only trained personnel should use the RapidAER, and should have read and understood the manual. If the unit is not used in the correct manner, the cleaning and decontamination carried out by the unit may be impaired. The operator has various options on how to interface with the RAPIDAER machine. For ease of use, speed and efficiency the RAPIDAER machine is configured to operate using a TAG system. There are three types of TAGS: The Operator TAG:- which contains all the relevant data about the operative. The Scope TAG:- which contains all the relevant data about the endoscope. The Connection Manifold TAG – which contains all the details about endoscope connection (All of these are covered in more detail on the following pages). The TAGS are pre-programmed by the RAPIDAER manager with all the relevant details. The TAG system allows the operator to follow the prompts / instructions on the computer screen, and by presenting the TAG to the tag reader, the RAPIDAER machine will progress onto the next step in the process. However, should the operator not have their TAG for whatever reason, RAPIDAER also has the option to allow access through the computer touch screen. Each operator will also have an identification number and a PIN, these can be used to identify the operator to the RAPIDAER manually. The operator will also be required to use the computer touch screen during the endoscope loading process. The buttons that are active and can be pressed to select an option or confirm a question, are always coloured in green. The only other button that can be pressed is the Pause button, active once the cycle has started. To operate a touch screen button, the operator should gently, but firmly press their finger on the button on the computer screen.

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RAPIDAER CONTROL PANELS: DIRTY SIDE (LOAD SIDE) CONTROL TOUCH SCREEN

CLEAN SIDE (UN-LOAD SIDE) CONTROL PANEL

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OPERATOR ID PERSONAL IDENTIFICATION NUMBER (PIN) Under the “Hospital protocols” section of the RAPIDAER control functions, you are required to choose a PIN and sequential ID number for each operator or manager who has access to your RAPIDAER machine. The PIN should be a confidential identification known only to the assignee, and the RAPIDAER manager. It is recommended that a secure log or record of the PIN’s should be kept by the hospital (RAPIDAER manager) to cover for the event of an operator losing their TAG, and forgetting their PIN. It doesn’t matter if operators choose a PIN that someone else already has, because it has to be used with their unique sign on ID number. Once an ID & PIN and a TAG have been assigned to a user’s log on, the operator does not need to use their PIN because all the necessary information is stored on the operator TAG. The operators ID & PIN will be required if a TAG is lost or stolen; so that the operator can access the RAPIDAER machine manually. The ID & PIN are also needed to reassign a new TAG for the operator.

Please refer to the following section on TAG’s , for lost or damaged TAG’s

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OPERATOR ID TAG: Fig: Tag 1 Each operator that is assigned to your Autoscope RAPIDAER machine, should be allocated a unique personal TAG. The operator ID TAG provides several functions: 1) Identifies the operator. 2) Automatically logs the operator into the RAPIDAER machine. 3) Automatically confirms the operator’s access level status. 4) The TAG is required to open the RAPIDAER doors for both loading & unloading. 5) If a tag is lost or stolen. The RAPIDAER Manager should assign a new tag to the operator, this will disable the lost TAG.

SCOPE ID TAG: Fig : Tag 2 Each Scope that will be re-processed in the RAPIDAER requires a unique identification TAG rated to IP68. This will identify the scope to the RAPIDAER machine, automatically confirming the parameters for cleaning and testing etc. The TAG will also allow the endoscope to be tracked within the DATA storage and printouts.

CONNECTION HUBS THE CONNECTOR HUB. This is used with each scope that is installed into the carrier basket. There are a large number of hubs with connections dedicated to number of channels in that particular family of endoscopes. The hubs vary dependant on manufacturer and the individual connectors required to fit the individual channels.

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Operators Manual – RA015

CONNECTOR HUBS ID TAG The connector hub tag is similar to endoscope ID tag and is rated to IP68. The information stored on the tag allows for the number of channel that are connected to be verified against the number on channels on the endoscope tag and then during the process these connections are monitored.

NOTE: All accessories used with the RapidAER, and to connect the endoscopes must comply to Cantel Medical’s specification.

PRE-LOADING A SCOPE: PREPARING THE SCOPE BASKET: The RAPIDAER machine uses a scope carrier basket to house the scope in the machine. The basket is pre-loaded with the scope on a worktop, and placed into the RAPIDAER when ready. On completion of the wash cycle, the scope is removed in its basket, so that another scope basket can be loaded and washed whilst the previous scope is removed from the basket. The carrier basket can then be returned to the load side, for re-loading with more scopes. Take an empty basket and then select the correct hub for the endoscope to be reprocessed. Each type of endoscope will have a specific connection manifold with the correct number of channel connectors suitable for that family of endoscopes. The manifold is slid into the end of the basket, the scope is then placed in the basket and the connections made to the scope.

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LOADING THE SCOPE INTO THE RAPIDAER MACHINE Open the RAPIDAER load door, using the operator tag or foot pedal.

Place the end of the basket on the side guides and slide the basket forward into the chamber until it rests totally in the base area.

Pull the basket back towards the front of the machine to locate the connectors into the irrigation ports on the inside front face of the chamber. When located, lock in position by moving the locking arm across the basket.

When the scope is loaded securely, Check the computer screen, and answer the question regarding channel separators, before closing the door,

UN-LOADING A SCOPE FROM THE RAPIDAER MACHINE: To unload a scope, it is the reverse of the load operation. When the computer instructs that the unload door can be opened, the operator should present their TAG to identify the unload operator and then retag or use the foot switch to open the clean side door. Move the locking arm across to unlock the connections and then slide the basket upwards and remove through the clean door. Close the door using the tag or foot switch. The RAPIDAER machine will not proceed to the next step until the door has been closed properly.

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HOW TO “LOG ON” RAPIDAER RAPIDAER functions via the onboard touch screen computer. The following steps show how to LOG ON to RAPIDAER using the touch screen. RAPIDAER Home screen When at rest, the RAPIDAER will display the Home Screen. In order to access the operating system, present the operator TAG to the reader. Alternatively, touch the green box as indicated. If the TAG is used, the door can then be opened by using the operator tag again or pressing the foot switch, and the RAPIDAER will ask for the Scope ID. If the green box is pressed, the computer will proceed to the LOG ON screen LOG ON screen Touch the user ID box to input the users 4 digit reference number via the Key Pad screen

The numerical Key pad screen Enter the user 4 digit ID number Press OK to accept

Enter PIN Touch the PIN box to activate the numerical keypad

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The numerical Key pad screen Enter the user 4 digit PIN Press OK to accept

Now press LOG ON The door will open and the RAPIDAER will ask for the hub and scope ID

All the information displayed on the screen will be stored in the Data Log: Ie: User ID, name, PIN, TAG, including dates & times.

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AUTOMATIC RE-PROCESS CYCLE The normal re-processing cycle for either a one or two scope process is in 7 stages. 1. Leak Test 2. Gross Wash and Lumen Patency 3. Detergent wash 4. Rinse 5. Disinfectant Clean 6. Disinfectant Rinse 7. Air flush The Computer display on the Load side of the RAPIDAER machine is the main user interface. Most of the wash cycle sequence can be performed by the use of the Operator TAG, Manifold TAG and the Endoscope TAG. Additional operator input is by pressing buttons on the touch screen. The touch screen buttons are all indicated when they are active and are mostly located across the bottom of the computer screen. The computer screen display prompts and instructs the operator on the physical actions to be taken during the load and un-load sequences. During the wash cycle process, the computer screen displays the stage of the cycle that is being performed. This information is repeated on the unload side, scrolling display. Other information displayed on the screen includes: The load operator for each scope The hub identification The endoscope identification The PAUSE cycle button.

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