Operators Manual
40 Pages
Preview
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Microwash Q-Rinse System
Contents Contents...3 1. Introduction...4 2. Warning, Cautions and Symbols...5 3. Description...7 3.1 Features...7 3.2 Function Modes...7 3.3 Key Components...8 3.4 Front Control Panel...9 3.5 Back Panel...11 3.6 Top Panel...12 4. Set up and Operation...13 4.1 Set Up...16 4.2 Operation: Automated Cycle...20 4.3 Operation: Manual Cycle...21 4.4 Operation: Foot pedal Operation...22 4.5 Operation: Refilling bottle...23 4.6 Operation: Disinfection and Sterilization...24 5. Troubleshooting...26 6. Maintenance...28 7. Warranty...29 8. Specifications...30 9. Supplies and Ordering...32 10. Special Instructions / Notes regarding the Microwash Q-Rinse and Electromagnetic compatibility (EMC) testing to EN 60601-1-2:2015...33 11. Customer and Technical Support...37
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1. Introduction Altomed supports the surgical community with superior products, technical support and customer service. The Microwash Q-Rinse System is built by Altomed in the UK. • The Microwash Q-Rinse system will help you standardise the rinsing procedure of reusable surgical instruments and tubing after surgery and prior to processing. • Its time saving design is an efficient alternative to the manual syringe rinsing method. • The 15 second automated cycles regulates the necessary flow of fluid and air. • The manual mode allows for easy transition between cycles at any time if required due to narrow lumen. • The Microwash Q-Rinse system is recognized globally among the surgical community and is becoming the standard rinsing procedure for many surgical centres.
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2. Warning, Cautions and Symbols Carefully read all warnings, cautions and instructions before use. See also Section 11 for electrical information. The following warnings and cautions and notes apply to all Microwash Q-Rinse components unless otherwise specified: General Warnings • DO NOT attempt to modify the Microwash Q-Rinse system in any way. Modifying the Microwash Q-Rinse System may affect the device operation and user safety. Modification will also void the warranty. • DO NOT interchange any other manufacturer’s equipment or accessories with the Microwash Q-Rinse system unless the Altomed Quality Department confirm otherwise. Only use an Altomed Foot Pedal. The warranty is exclusive to Microwash Q-Rinse System parts and accessories only. • DO NOT use the Microwash Q-Rinse in the presence of explosive gases or other flammable substances. • DO NOT open any panels on the machine while the Microwash Q-Rinse is plugged in to avoid electric shock. There are no serviceable parts inside the machine. Contact Altomed Limited Repairs Department or approved Distributor for repair information. A list of Approved Distributors is available from Altomed. • DO NOT aim the tubing at any part of the body while the Microwash Q-Rinse System is plugged in. The Microwash Q-Rinse operates under pressure. • DO NOT disconnect the bottle cap or any tubing lines while the system is ON and pressurized. (If the pressure is not allowed to be safely released, disconnecting the tubing lines can cause pressurized fluid to spray.) • DO NOT carry the machine by the tubing or the cap. • DO NOT sterilize the bottle in a peel pouch or with the cap on as it may collapse and be rendered unusable. • In the event the fluid and air do not pass from the tubing during use. Stop the machine by pushing the Stop button and contact Altomed for advice on +44 (0) 191 519 0111. • Return the machine to Altomed for inspection if the machine has been dropped and does not function correctly. Damaged casings need to be replaced to prevent fluid ingress. If a drop has resulted in the case being damaged, return to Altomed or Authorised Distributor for inspection.
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General Cautions • Carefully read this manual before initial operation of this system or if an untrained user. If in any doubt contact Altomed or Authorised Distributor. • The Microwash Q-Rinse System must only be connected to a grounded electrical receptacle. • Use of the Microwash Q-Rinse System does not absolve user from following your facility’s policies and procedures for cleaning or decontamination of surgical instruments. All items rinsed with the Microwash Q-Rinse should be inspected for cleanliness and integrity prior to further processing. This is not a disinfection machine. Special Instructions / Notes regarding the Q-Rinse System and Electromagnetic compatibility (EMC) testing to EN 60601-1-2: 2015 The Q-Rinse system is suitable for use in a professional healthcare facility, except near HF surgical equipment or outside the RF shielded room of a medical system for magnetic resonance imaging where the intensity of EM disturbances is high, or in a home healthcare environment. WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Q-Rinse system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Page 6
Symbols Used On The Machine Name and address of manufacturer.
Altomed catalogue number used for device identification. Device lot number used for traceability. Consult instructions for use for important cautionary information (e.g. warnings and precautions) unable to be printed on the device. WEEE Symbol. Waste electrical electronic Equipment. Do not dispose of as general waste. Return to Altomed or Authorised Distributor for recycling after end of life CE mark. Medical device meets the current regulatory and legislative requirements. Instructions for use. Refer to the Instruction Manual enclosed with the device. altomed.com
3. Description The Microwash Q-Rinse system provides a consistent method for rinsing patient fluids and debris from surgical tubing and instruments. A pressurised stream of air follows the rinse cycle to make sure that the majority of rinsing fluid is cleared from the inner channels. The contaminated surgical tubing or instruments should be rinsed immediately after use to prevent debris drying inside the lumen, preferably no later than 30 minutes. Note: Residual moisture is desired within the inner channels of the medical device and tubing to prevent any remaining biofilm from drying in the lumen. If the medical device to be rinsed is not being sent for processing straight away fill the lumen with a pre-cleaning solution such as Ruhof Prepzyme XF or similar. Rinse this out with sterile water for irrigation (or similar) prior to processing. 3.1 Features Some of the features of the Microwash Q-Rinse system are summarised below. • One automatic cycle has a fluid run of 15 seconds followed by an air cycle of 15 seconds. • There is a manual override feature to allow the user to select fluid or air depending upon the device being processed • Positive pressure delivery system • Selection of adaptors for variety of instrument interfaces, some of which can be cut to size • 1000ml bottle • Single connection instrument interface • Compact countertop-sized unit 3.2 Function Modes • Automatic Mode: Fluid followed by air • Manual Override • Fluid Only • Air Only • Foot Pedal (Optional)
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3.3 Key Components Microwash Q-Rinse System: Key Components Figure 1
Key 1. Bottle cap
10. Power supply
2. Quick disconnect (dual)
11. Power lead
3. Quick disconnect (single)
12. Cycle switch (on)
4. 1 litre bottle for fluid
13. Stop switch
5. Air/fluid tubing
14. Footpedal (Optional)
6. Air supply tubing
15. Accessory pack
7. Wire brush
16. Pinch (air and fluid) valves
8. Storage tray
17. Instrument interface tubing
9. Front bezel Page 8
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3.4 Front Control Panel Front Control Panel Figure 2
The front control panel contains both the automatic and manual control (cycle) switches in addition to the Fluid and Air Valves. The front panel functions are described in the order indicated in Figure 2, from left to right: Cycles: Automatic Cycle Pushing the Cycle switch once will operate the automatic program which consists of two cycles, each lasting a minimum of 15 seconds, first fluid then air. After completing the Automatic Cycle, the system will reset itself for the next program Manual Override Function To manually override the Automatic Cycle, push the Cycle button a second time. Repeated pushing of the Cycle button will continue to alternate between fluid and air. Note: If manually overriding the Automatic Cycle, YOU MUST press the Stop Button before operating the unit again in order to properly reset the Automatic Cycle mode.
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If the fluid starts to back up the blue tubing during use, it means the blockage is severe or the lumen very narrow. If there is a blockage use the wire brush or an impregnated sponge designed for cleaning lumen (like a Ruhof InstruSponge); if a narrow lumen, then switch to the Air Cycle on the manual mode to flush away the backed-up fluid. Return to the fluid path if needed. Stop: Push the stop button to interrupt the current operation and reset the system. Fluid Valve/ air Valve: These valves open and close in response to the Microwash Q-Rinse system’s timing circuits. The blue tubing segment between the bottle and the “Y” connection is to be placed in the Fluid Valve. The clear tubing segment between the bottle and the “Y” connection is to be placed in the Air Valve. The amber lights adjacent to the valves illuminate when the valve is open.
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3.5 Back Panel Back Panel Figure 3
The back panel contains the AIR OUT connector, the POWER IN connector, FOOT PEDAL connector, and the POWER switch. Refer to Figure 3 for locations of the components of the Back Panel. Power Switch: The Toggle switch turns the unit on or off. The symbol “I” being On and “O” being off Air Out: The Air Out connection delivers approximately 30 psi to the fluid container. The spring lock mechanism prevents accidental disconnection of the rear air supply line. Foot Pedal: The Foot Pedal connection is for the optional Foot Pedal. Power In: Connect the Microwash Q-Rinse Machine to a regulated 12-volt supply by using the Altomed Power supply REF: A11074 (see Section 9).
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3.6 Top Panel Top Panel Figure 4
Top Panel The top panel features storage compartments for the wire brush and various connectors used to adapt the Microwash Q-Rinse system to various instruments and tubing. See Figure 4. A deep well is provided to hold the 1000ml bottle.
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4. Set up and Operation This section details the recommended set up and operational procedures for the Microwash Q-Rinse System. If in any doubt, contact Customer Services at Altomed Limited on: Tel: +44 (0) 191 519 0111 or E-mail [email protected] The Microwash Q-Rinse System is designed to interface with a variety of surgical instruments by using standard luer adaptors. A storage tray is provided on the top of the unit to keep these adaptors available. A smaller diameter cleaning brush is included to assist in clearing blockages in metallic lumens. CAUTION #1 Follow your facility’s Standards of Practice for personnel working in the decontamination, preparation and sterilization area. Personal protective equipment (PPE) including gloves, apron, sleeves and visor or protective eyewear must be worn when cleaning contaminated medical instruments to reduce the risk of cross contamination. Users of the Microwash Q-Rinse System must still adhere to the facility’s Standards of Practice for sterilization and sterility assurance for cleaning medical devices. In the UK this includes compliance with recommended practices covering the preparation and decontamination of instruments, see “Choice Framework for Local Policy and Procedures” issued by the Department of Health. First Use • Unpack the Microwash Q-Rinse System, place all the parts on a clean flat surface and check to make sure all the items as in Figure 1 (page 8 above) are present and correct; the Foot Pedal is an optional extra and is not supplied as part of the System. • Check to make sure there has been no shipping damage. Contact the Quality Department at Altomed or the Authorised Distributor in the case of any problems. DO NOT USE ANY DAMAGED PARTS. • Remove the short protective segments of silicone tubing from the pinch valves and discard in the general waste. • Place the adaptors into the storage compartment on the top panel. • Place the wire brush alongside the container in the appropriate storing compartment.
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Table 1: Pre-Use Checks
* See Page 8 for “Item” References
Part Description
Item Numbers*
Checks to be carried out
Tubing Set
5 and 6
Check all silicone tubes for signs of wear or physical damage such as holes, stretches, splits or squashing. If damaged replace.
5
Ensure the “Y” connector is secure in the tubes and not damaged. If damaged replace.
2 and 3
Ensure the joints around the male connections are all secure and that the connectors themselves are not damaged. Check for cracks or chips etc. If damaged replace.
2
Ensure the hexagonal nut on the air/fluid tubing connector is secure, if loose tighten or replace bottle cap.
2 and 3
Ensure the 1 x black gasket on the elbow connector is present and undamaged and that the 2 x black gaskets on the air/fluid tubing cap connector are also present and not damaged. If missing or damaged replace.
17
Ensure the luer connector is present and secure in the end of the interface tubing. If it is missing replace it.
1
Ensure the white gasket is secure inside the cap and that it is not damaged. Check for wrinkles, splits, snaps or squashing. If damaged replace.
2 and 3
Ensure both the female connectors are secure in the cap and are not loose or damaged. Check for cracks or chips. If damaged replace.
2
Check that the metal pin in the air/fluid connector is not damaged and that the metal plate slides down and springs back up. If damaged replace.
2
Ensure the PTFE (white) tape is secured around the metal air input connector on the cap. If damaged replace.
1
Ensure there is no damage to the silicone tube, especially around the connector, and that it is securely on the connector inside the cap. If damaged replace.
1, 2 and 3
Ensure the male and female connectors are fastened together and secure. If unable to secure replace bottle cap.
Bottle Cap
Bottle Cap Complete
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Part Description
Item Numbers*
Checks to be carried out
Bottle
4
Ensure there is no physical damage to the bottle, cracks, splits, holes etc., and that the threads are not damaged and that the structure is not deformed. Dispose of any failed bottles and replace with new ones.
4
Ensure the bottle is clean and dry and does not have residues in the bottom. If dirty clean, may be sterilized if deemed necessary.
10 and 11
Check the grommets, connectors, plugs and wire for any signs of physical damage, e.g. exposed wires, splits in the cable, cracks in casing etc. Do not use if there is any sign of damaged
10 and 11
Make sure the connection between the lead and power supply unit is secure, if loose push together to ensure the connection is secure.
N/A
Check for any physical damage to the casing e.g. cracks, chips etc., or other physical damage to the valves or switches or connectors. If damaged replace.
N/A
Ensure the four rubber feet are in place and secure to prevent movement of the machine. If missing replace.
15
Check to make sure the 10 adaptors are present and ready for use if needed. If missing replace.
N/A
Ensure the waste receptacle is designed to accept contaminated fluid waste. If not designated for contaminated waste, source a suitable receptacle approved by your facility.
6 and 16
Ensure the blue tubing goes into the Fluid Valve and the clear tubing goes into the Air Valve. Ensure the elbow connector on the green tubing has clicked securely into place. If not set up accordingly and re-read the Instruction Manual.
10 and 11
Ensure the Power Supply and lead cannot be splashed or exposed to water. Use splash protection over sockets if present.
N/A
Run an automatic cycle to ensure fluid and air flow is correct and that the switch over between fluid and air takes place. Do not use if the cycle fails, send for repair.
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Power Supply and Lead
Q-Rinse Machine
Assembled Q-Rinse System
4.1 Set Up
* See Page 8 for “Item” References
STEP 1 See Caution #1 and complete all pre-use checks as advised in Table 1 (page 14 above). Position the machine on a flat surface near a grounded wall outlet and close to the facilities waste receptacle for disposing of contaminated fluids (e.g. sink). Ensure there is sufficient free space around the machine to permit proper connection, use and dismantling procedures. Do not position the device in a way that will make it difficult to readily access the plug. Plug in the A11047 Altomed power supply (Item 10) into the hospital grade power cord (Item 11) supplied, (this may differ from the picture in Figure 1 depending upon which country you are in.) Ensure the machine is not pushed up against a wall or other solid surface causing the power connector and lead to bend at the back of the machine. Plug the A11047 Altomed power supply (Item 10) into the back of the Microwash Q-Rinse System (Figure 5a). Make sure the plug is fully engaged. Plug the power cord (Item 11) into a grounded wall outlet. A standard wall plug has been supplied to allow the use of splash protection covers if required. Power Supply Connection Figure 5a
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STEP 2 Fill the bottle (Item 4) with sterile water for irrigation (or similar) leaving one inch of space from the top for proper operation. DO NOT OVER FILL. Screw the metal cap (Item 1) onto the bottle (Item 4). The bottle cap must be securely on the bottle BEFORE it is put into the well! Place the bottle (Item 4) into the well located on the top of the machine. Position so that the quick disconnect (single) fitting (Item 3) faces the rear of the unit. Connect the air supply tubing (Item 6) to the metal female connector on the bottle cap. The tubing will “click” into place when the connection is secure. STEP 3 At the back of the unit, click the white elbow connector on the air supply tubing (Item 6) into place (Figure 5b). The elbow connector will “click” when secure. The air supply tubing (Item 6) MUST be in place before operating the Microwash Q-Rinse System otherwise the pressure will not build in the container. Air Supply Connection Figure 5b
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STEP 4 Connect the air/fluid tubing (Item 5) to the quick disconnect (dual) fitting (Item 2) on the bottle cap. It will “click” when the connection is secure. At the front of the unit, install the rinse lines through the pinch valves (see Figure 5c below). The BLUE tubing line MUST run through the Fluid valve. The CLEAR line MUST run through the Air valve. Installing Fluid and Air Lines Figure 5c
STEP 5 (Optional footpedal) Only use an Altomed footpedal. Connection of Optional Footpedal Figure 5d
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At the back of the Microwash Q-Rinse System, plug in the Foot Pedal connector (see Figure 5d). Place the Foot Pedal on the floor in a location which is convenient for use. Be constantly aware of a possible trip hazard. Switch on the machine Figure 5e
Turn on the Microwash Q-Rinse System by pressing the power switch on the rear panel (Figure 5e). The symbol “I” being On and “ O ” being off.
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4.2 Operation: Automated Cycle
* See Page 8 for “Item” References
STEP 1 See Caution #1 and complete all pre-use checks as advised in Table 1 (see page 14 above). Connect the instrument interface tube (Item 17) to the item to be rinsed (Figure 6), use the adaptor pack (Item 15) and/or A11047 “Y” Dual Rinse Fitting if necessary. Device Connection Figure 6
STEP 2 Press the Cycle button (Item 12) once to begin the automated rinse cycle. The amber light next to the fluid valve will light up indicating that the valve is open. After 15 seconds the fluid valve will close and the air valve open. The amber light next to the air valve will now be illuminated. After 15 seconds the air valve will close, the machine will stop and both amber lights will be turned off. This completes the automated cycle. See Table 2 (page 26 below) for Troubleshooting if necessary. STEP 3 Repeat Steps 1 and 2 for any further lumen on the device. STEP 4 Inspect the rinsed device for cleanliness and function prior to further processing, e.g. disinfection or sterilization. Page 20
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4.3 Operation: Manual Cycle
* See Page 8 for “Item” References
STEP 1 See Caution #1 and complete all pre use checks as advised in Table 1 (see Page 14 above). Connect the instrument interface tube (Item 17) to the item to be rinsed (Figure 6), use the adaptor pack (Item 15) and/or A11047 “Y” Dual Rinse Fitting if necessary. STEP 2 Press the Cycle button (Item 12) once to begin the automatic rinse cycle. At any time during the automatic cycle, press the Cycle button (Item 12) a second time to enter the manual mode. After pressing the Cycle button (Item 12) a second time, the Microwash Q-Rinse System will be in the manual mode and the Cycle button (Item 12) will begin to flash. While in the manual mode, the user can alternate between fluid and air by further pressing of the Cycle button (Item 12). The amber light adjacent to the open valve will illuminate. STEP 3 To end the manual mode, press the stop button (Item 13). The Cycle button will stop flashing and the unit will reset for the next use. The manual mode will time out after 60 seconds if no buttons are pressed. STEP 4 Repeat Steps 1 to 3 for any further lumen on the device. Use the luer adaptors (Item 15) as required. STEP 5 Inspect the rinsed device for cleanliness and function prior to further processing e.g. Disinfection or Sterilization. Note: After using manually shortened modes, you must press the Stop to reset the internal timers.
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