Q-Rinse System Operators Manual Issue 05 Sept 2020

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Contents Contents... 3 1. Introduction... 4 2. Warning, Cautions and Symbols... 5 3. Description... 8 3.1 Features... 8 3.2 Function Modes... 8 3.3 Key Components... 9 3.4 Front Control Panel... 10 3.5 Back Panel... 12 3.6 Top Panel... 13 4. Set up and Operation... 14 4.1 First Use... 14 4.2 Table 1: Pre-Use Checks... 15 4.3 Set Up... 17 4.4 Operation: Automated Cycle... 21 4.5 Operation: Manual Cycle... 22 4.6 Operation: Refilling bottle... 23 4.7 Operation: Disinfection and Sterilization... 24 5. Troubleshooting... 28 6. Maintenance... 30 7. Warranty... 31 8. Specifications... 32 9. Supplies and Ordering... 34 10. Special Instructions / Notes regarding the Q-Rinse and Electromagnetic compatibility (EMC) testing to EN 60601-1-2:2015... 35 11. Customer and Technical Support... 39

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1. Introduction Altomed supports the surgical community with innovative products, technical support and customer service.

MD

The Q-Rinse is classified as a medical device.

The Q-Rinse is built by Altomed in the United Kingdom. • The Q-Rinse will help you standardise the rinsing procedure of reusable ophthalmic 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 Q-Rinse is recognized globally among the surgical community and is becoming the standard rinsing procedure for many surgical centres.

Intended Use The Q-Rinse is intended to rinse the lumen of an ophthalmic medical device (such as a phacoemulsification handpiece or irrigation / aspiration handle), straight after its use in a surgical procedure. It is used to help rinse out any contaminants from inside the lumen and prevent them from drying on the inner wall in preparation for the washing, disinfection and sterilization stages carried out later. Notes: The lumen is kept damp after rinsing, ready for the application of a suitable preparation solution such as Ruhof Prepzyme XF or similar. This is not a disinfection device. The devices rinsed must go through the decontamination instructions provided by their manufacturers.

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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 Q-Rinse components unless otherwise specified: General Warnings • DO NOT attempt to modify the Q-Rinse in any way. Modifying the Q-Rinse may affect device operation and user safety. Modification will also void the warranty. • DO NOT interchange any other manufacturer’s equipment or accessories with the Q-Rinse unless Altomed confirm otherwise. The warranty is exclusive to Q-Rinse parts and accessories only. • DO NOT use the Q-Rinse in the presence of explosive gases or other flammable substances. • DO NOT open any panels on the machine while the Q-Rinse is plugged in to avoid electric shock. There are no serviceable parts inside the machine. Contact Altomed repairs repartment or approved distributor for repair information. A list of approved distributors is available from Altomed. Any attempt to open the machine may invalidate warranty. • DO NOT aim the tubing at any part of the body while the Q-Rinse is plugged in. The Q-Rinse operates under pressure. • DO NOT disconnect the bottle cap or any tubing lines while the 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 refer to the trouble shooting guide. • Return the machine to Altomed for inspection if the machine has been dropped and does not function correctly. If a drop has resulted in the casing being damaged, return to Altomed or authorised distributor for inspection. • Keep power adaptor away from water sources • Clean the handpiece separately and after immersion in any bath. • It recommended to use water for irrigation (deionised water). It is not recommended to use saline

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General Cautions • Carefully read this manual before initial operation or if an untrained user. If in any doubt contact Altomed or authorised distributor. • The Q-Rinse must only be connected to a grounded electrical outlet. • Use of the Q-Rinse does not absolve the user from following your facility’s policies and procedures for cleaning or decontamination of ophthalmic surgical instruments. All items rinsed with the 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 and Electromagnetic compatibility (EMC) testing to EN 60601-1-2: 2015 The Q-Rinse is suitable for use in a professional healthcare facility, except near HF surgical equipment or outside the RF shielded room of a medical for magnetic resonance imaging where the intensity of EM disturbances is high, or in a healthcare facility. 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. This will also invalidate the warranty. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be no closer than 30 cm (12 inches) to any part of the Q-Rinse, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. IMPORTANT! Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Power Adaptor The power adaptor is only intended for use with the Q-Rinse and is for indoor use only. Keep dry. It is not protected against ingress of water. Protect from excessive force or shock. Do not pull out plug with excessive force. No user serviceable parts inside. Use only rated input range as indicated on the bottom of the equipment. Locate near an accessible, properly grounded outlet.

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Symbols Used On The Machine Name and address of manufacturer.

Fragile handle with care.

Altomed catalogue number used for device identification.

Keep dry (shipping).

Device lot number (batch code) used for traceability. This way up. Consult instructions for use for important cautionary information (e.g. warnings and precautions) unable to be printed on the device.

Non-sterile

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.

85°C

Temperature limit

-30°C

CE mark. Medical device meets the current regulatory and legislative requirements. Instructions for use. Refer to the Instruction Manual enclosed with the device.

MD

This is a Medical Device.

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3. Description The used ophthalmic device should be rinsed immediately after use to prevent debris drying inside the lumen, preferably within 30 minutes. Carry out initial cleaning on the outer body by following the Handpiece manufacturer’s instructions for use. The Q-Rinse provides a consistent method for rinsing residual fluids and debris from ophthalmic surgical devices. A pressurised stream of air follows the rinse cycle to make sure that the majority of water is cleared from the inner channels. 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, then follow manufacturers instruction prior to processing

3.1 Features Some of the features of the Q-Rinse 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 (e.g. narrow lumen devices) • Positive pressure delivery • 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

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3.3 Key Components Q-Rinse: Key Components Figure 1

Key 1. Bottle cap (With fittings)

8. Power Supply

2. 1000ml bottle for fluid

9. Power Lead

3. Air/fluid tubing

10. Green cycle switch (on)

4. Air supply tubing

11. Blue stop switch

5. Wire brush

12. Accessory Pack

6. Storage tray

13. Pinch (air and fluid) valves

7. Front bezel

14. Instrument interface tubing

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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: Cycle Button: Automatic Cycle Pushing the Cycle button 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 unit 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 cycle if needed. Stop Button: Push the stop button to interrupt the current operation and reset the unit. Fluid Valve/ Air Valve: These valves open and close in response to the Q-Rinse’s timing circuits. The blue tubing segment between the bottle and the “Y” connection is to be placed in the Fluid Valve (see Figure 2). The clear tubing segment between the bottle and the “Y” connection is to be placed in the Air Valve (see Figure 2). The amber light adjacent to the valve illuminates 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 and the POWER switch. Refer to Figure 3 for locations of the components of the Back Panel. Power Switch: The Power 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 bottle. The spring lock mechanism prevents accidental disconnection of the rear air supply line. Power In: Connect the Q-Rinse 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 luer connectors used to connect the Q-Rinse 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 Q-Rinse. If in any doubt, contact Altomed on: Tel: +44 (0) 191 519 0111 or E-mail [email protected] The Q-Rinse is designed to interface with a variety of ophthalmic surgical devices by using standard luer adaptors. A storage compartment is provided on the top of the unit to store these adaptors. A smaller diameter cleaning brush is included to assist in clearing blockages in 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 Q-Rinse 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.

4.1 First Use • Unpack the Q-Rinse, place all parts on a clean flat surface and check to make sure all items as in Figure 1 (page 9 above) are present and correct. • Check to make sure there has been no shipping damage. Contact 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 storage compartment.

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4.2 Table 1: Pre-Use Checks

* See Page 9 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.

14

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.

Bottle Cap

1, 2 and 3

Ensure the male and female connectors are fastened together and secure. If unable to secure replace bottle cap.

Bottle

4

Ensure there is no physical damage to the bottle, the threads are not damaged and that the structure is not deformed. Dispose of any failed bottles and replace.

Bottle Cap

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Part Description

Power Supply and Lead

Q-Rinse

Assembled Q-Rinse

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Item Numbers*

Checks to be carried out

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. Ensure no contact with water or other fluids. 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 or other physical damage to the valves, 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.

N/A

Run an automatic cycle to ensure fluid and air flow are correct and that the switch over between fluid and air takes place. Do not use if the cycle fails, return for inspection.

N/A

Fill bottle. Using a calibrated measuring device, ensure the water output is >140ml for every cycle until the bottle is empty. Check air cycles last 15 seconds. Do not use if the tests fail, return for inspection.

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4.3 Set Up

* See Page 9 for “Item” References

STEP 1 See Caution #1 and complete all pre-use checks as advised in Table 1 (page 13 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 A11074 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 A11074 Altomed Power Supply (Item 10) into the back of the Q-Rinse (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 optimum operation. DO NOT OVER FILL. Screw the metal cap (Item 1) onto the bottle (Item 4). The bottle cap must be securely screwed onto the bottle BEFORE it is put into the well! Only use the bottle supplied with the Q-Rinse which is specifically designed to withstand the pressures associated with the machine. Use of third party bottles may result in reduced performance and invalidate the warranty. Place the bottle (Item 4) into the well located on the top of the machine. Position the Poly bottle so that the two fittings on the Bottle Cap face the front of the console. Connect the luer fitting on the clear tube of the Air/Fluid Tubing to the connection on the Bottle Cap labeled AIR with a twisting motion until snug. Connect the luer fitting on the blue tube of the Air/Fluid Tubing to the connection on the Bottle Cap labeled FLUID with a twisting motion until snug. (Refer to Figure 5b) Connecting Air/Fluid Tubing Figure 5b

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STEP 3 At the back of the unit, insert the white elbow connector on the green supply tubing (Item 6) into place (Figure 5c). The elbow connector will “click” when secure. The green supply tubing (Item 6) MUST be in place before operating the Q-Rinse otherwise the pressure will not build in the bottle. Figure 5c

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 5d 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 5d

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STEP 5 Switch on the machine Turn on the Q-Rinse System by pressing the power switch on the rear panel (Figure 5e). The symbol “I” being On and “ O ” being off. Figure 5e

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