FLOW-i Cleaning and Maintenance Users Manual Rev 04 March 2019

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Table of contents

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Flow-i Anesthesia System, User's Manual Infologic 1.30

Introduction Routine cleaning Maintenance and service Malignant hyperthermia - Preparing the Flow-i for susceptible patients

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Flow-i Anesthesia System, User's Manual Infologic 1.30

| Introduction | 1 |

1 Introduction 1.1 General information Unless otherwise stated, the information in this User's Manual is valid for the Flow-i anesthesia system. The manual contains the information needed for the safe cleaning and maintenance of the anesthesia system. Up until system version 4.3 of Flow-i, this information was part of the main user manual. As of system version 4.3, the information is included in this separate user manual. As cleaning practices vary widely among health care institutions, it is not possible for the manufacturer to specify particular practices that will meet all needs, or to be responsible for the effectiveness of cleaning procedures carried out in the patient care setting. The manufacturer recommends cleaning the patient cassette once a month. The manufacturer recommends methods using the specified equipment and procedures outlined in this manual. Other methods may work but are not covered by the warranty.

1.2 Hygiene The carbon dioxide absorbent has a potent cidal effect on microorganisms and only a low number of resistant spores pass through the absorber. Studies strongly suggest that patients rarely contaminate the absorber with 1 significant levels of bacteria/viruses . The bactericidal effect will however not be in effect if the absorber is bypassed. The manufacturer recommends that a bacterial/viral filter is always connected to the expiratory connection on the patient cassette. This will minimize the risk of cross-contamination. If possible, cleaning should be performed immediately after use and always before disinfection/autoclaving. Blood or other residues should not be allowed to dry onto the devices. Water quality affects cleaning/disinfection. The manufacturer recommends using deionized water for this purpose. The water quality must never be less than drinking water quality.

When the accessories and/or auxiliary equipment are not covered by the manufacturer's CE mark on the anesthesia system, refer to cleaning instructions found in the equipment's user documentation.

1. Murphy et al. 1991 Flow-i Anesthesia System, User's Manual

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| 1 | Introduction |

Follow the recommendations regarding softening of water provided by the manufacturer of the washer disinfector. All personnel should be aware of the risk of parts being contaminated when disassembling and cleaning the system. All disposable parts must be discarded according to hospital routines and in an environmentally safe way.

1.3 Safety guidelines WARNING! Indicates critical information about a potential serious outcome to the patient or the user.

CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment.

Note: Indicates information requiring special attention.

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| Routine cleaning | 2 |

2 Routine cleaning 2.1 General information

When bacterial filters are not used, the recommended cleaning procedure includes the following steps:

WARNING! A system checkout must always be performed after cleaning of components.

• Disassemble • Wipe off/discard

Other accessories and disposables than those recommended by the manufacturer may alter or modify recommended cleaning procedures.

• Clean and rinse before disinfection

If a Servo DuoGuard filter is used, disinfection or steam autoclaving of the patient cassette, volume reflector and associated parts is usually not necessary.

• Assemble

• Disinfect • Dry • System checkout

When bacterial filters are used, the recommended cleaning procedure includes the following steps: • Disassemble • Wipe off/discard • Assemble • System checkout A complete cleaning procedure should still be performed at regular intervals according to hospital routines, or after treating a known carrier of pulmonary contagious agents.

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There are several disinfection alternatives. The patient cassette, volume reflector and associated parts may be disinfected using a Washer-Disinfector (ISO-15883-1) (recommended). They may also be dried after rinsing and then steam autoclaved. Refer to section Disinfection procedures on page 21. Use only validated processes if steam autoclaving the patient cassette, volume reflector and associated parts. Refer to section Steam autoclaving procedure on page 25.

2.2 Preparations and dismantling CAUTION: The system must not be disassembled further than described in this manual.

2.2.1 Remove external appliances 1. 2. 3. 4.

5.

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Shutdown the system. Disconnect the system from the power and gas supply. Disconnect any optional equipment from the anesthesia system. Remove the water trap and gas sampling line. Discard/empty any water present in the water trap. Remove patient tubing, Y-piece, and manual breathing bag.

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| Routine cleaning | 2 |

6.

7.

Remove the suction bottle/single use collection bag and the associated suction hose. Release the CO2 absorber using the locking switch and remove it.

2.2.2 Remove patient cassette The Cleaning Adapter kit from the manufacturer (order no. 66 81 910) is required for assembly/disassembly, cleaning, rinsing and disinfection of the patient cassette. The kit contains the following items:

The appearance of the CO2 absorber switch may vary (the bypassed symbol is not present on newer systems). Refer to the description in the main user manual for the anesthesia system.

Item

Description

1

Front adapter. Used for rinsing/disinfection of patient cassette.

2

Rear adapter. Used for disinfection of patient cassette.

3

Valve tool. Used for assembling/disassembling valves on the patient cassette.

4

Washing shackle. Used for washing the absorber valves of the patient cassette.

The appearance of the patient cassette cover may vary depending on the system in use.

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The procedure to remove the patient cassette is as follows: 1.

3.

To remove the patient cassette, use the intended grip located between the inspiratory and expiratory connections to lift the front edge of the cassette until a click is heard, then pull outwards.

4.

Unlock the caps on the inspiratory/expiratory valves using the tool (turn counter-clockwise to unlock).

Open the patient cassette cover by: A. Pressing the lid downwards (If necessary, on older systems, pressing the button on the right) B. Pulling the release catch

A

B

2.

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Release the patient cassette locking device.

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| Routine cleaning | 2 |

5.

Remove the caps and valve cages (A) and place the valve cages containing ceramic plates in a fine mesh box (B).

Flow-i Anesthesia System, User's Manual

6.

Re-attach the valve caps (turn clockwise to lock).

7.

Turn the patient cassette upside-down and remove the two absorber valves (turn counter-clockwise to unlock) in the order shown (first A, then B).

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8.

Gently pull down the spring mounted discs of the absorber valve to expose the spring apertures (A). Thread both legs of the washing shackle through the apertures (B) taking care not to damage the spring and slide the absorber valve onto the washing shackle (C).

2.2.3 Sample filters Remove and replace the inspiratory (right) and the expiratory (left) sample filters according to hospital routines.

1.

Using a 2.5 mm Allen key, unscrew the screw at the centre of the Inspiratory sample filter holder and the two screws on the Expiratory sample filter holder. Pull off the used filters and dispose according to hospital routines for contaminated waste.

2.

Replace with new filters and tighten the screws.

Note: Excessive force may damage the absorber valve spring. Check that the spring is functioning correctly before assembly. 9.

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Ensure that the expiratory outlet one-way valve is not damaged. The valve is located at the back of the patient cassette.

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The appearance of the inspiratory sample filters may vary depending on the system in use.

2.2.4 Remove volume reflector The volume reflector must also be cleaned when the patient cassette is cleaned. 1.

Remove the volume reflector adaptor (A).

A

B

2.

Firmly pull out the volume reflector from the system.

3.

If considered necessary, remove the safety valve (B) using an Allen key and thread it onto the metal stand together with the volume reflector adaptor.

For devices with serial numbers below 5001, the volume reflector adaptor has a steel wire retaining bracket. For devices with serial numbers above 5001, the volume reflector Flow-i Anesthesia System, User's Manual

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adaptor is delivered without this retaining bracket. The adaptor without the retaining bracket can be used on all Flow-i devices, while the adaptor with the retaining bracket may NOT be used for devices with serial numbers above 5001. To avoid any risk of confusion, it is a good idea to remove the retaining bracket from the volume reflector adaptor. For devices with serial numbers below 20000, the volume reflector material is dark. Cleaning the safety valve is usually not necessary unless special conditions apply; the patient is a carrier of pulmonary contagious agents etc.

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2.3 Wipe off/discard Wipe the exterior of the system, the patient cassette compartment, the volume reflector compartment and all removable parts with a soft lint-free cloth moistened in soap and water or a mild detergent. Wipe the system free of soap and detergent residues using a lint-free cloth moistened in water only. For contaminated surfaces, use ethyl- or isopropyl-alcohol (70%).

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After removing the patient cassette and volume reflector, avoid pouring or spraying any liquid into the open compartments. Avoid contact with electronics and electrical connectors when wiping.

Check the Suction unit bacterial/viral filter after each patient case for signs of moisture or fluid and replace if necessary. Fluid in the filter will compromise the functionality of the filter and Suction unit.

Discard disposable items according to local and environmental regulations.

Firmly pull the filter outwards and dispose it according to hospital routines for contaminated waste products.

Regularly check that the fan filter looks clean (i.e. black). If dusty, remove (snap off/snap on) and rinse in water. Shake out all excess water from the filter.

Attach the new filter by fitting the unmarked end into the back of the suction module and press until a click is heard. Ensure the filter is correctly secured in the locked position.

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2.3.1 Discarding consumables The following items need to be replaced at regular intervals or according to hospital routines: Item

Interval

Notes

Water trap

Replace the entire water trap once a month

Empty the water trap after 17 hours of active use, or when half full. The water collector can be cleaned separately. Refer to instruction below this table.

Patient suction collection bag

After each patient

Applicable only if used during treatment

Vacuum- and serial tubing used with the suction module

After each patient

Applicable only if used during treatment

Gas sampling line (single use)

After each patient if no other means has been used at the Y-piece

---

Exp. connection bacterial filter

After each patient if no other means has been used at the Y-piece

---

Heat and moisture exchanger (HME)

After each patient

---

Patient tubing

According to manufacturers instructions or hospital routines

---

Inspiratory and expiratory sample According to hospital routines filters

---

Suction unit bacterial/viral filter

Once every three months, or according to hospital routines

Replace if filled with fluid

CO2 absorber

When exhausted

---

Reusable CO2 absorber (option)

Replace soda lime when exhausted

Use gloves, protective glasses and facial protection according to soda lime manufacturer’s instructions when refilling the absorber.

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The CO2 absorber is considered hazardous waste and should be disposed of in accordance with hospital regulations and appropriate industrial and environmental standards. Discard the complete disposable CO2 absorber when used up. Never open the disposable CO2 absorber. Always use absorbers approved by the manufacturer. When using the reusable CO2 absorber, discard spent absorbent material and used filters according to hospital routines for hazardous material. For disinfection procedures for the reusable absorber, refer to section Washer-Disinfector on page 21. Do not clean or disinfect the bacterial/viral filter part of the water trap as this might cause irreversible damage to it.

2.4 Clean and rinse before disinfection Before disinfection, clean and rinse the patient cassette, volume reflector and associated parts according to hospital routines as soon as possible after use to improve disinfection and reduce the risk for cross-contamination between patients. • Begin by rinsing the exterior surfaces under running water. Use the cleaning adapters as described below to rinse the interior compartments of the equipment. • Visually check the cleaning adapters for cracks and fissures. Discard broken adapters. • Rinse the parts thoroughly in water (<35 °C/95 °F). Let the water flow through the parts to remove organic matter, e.g. blood, and other residues. Rinsing with water warmer than 35 °C (95 °F) may cause organic material to coagulate.

The following disinfectants may be used to clean the water container part of the water trap: • Ethanol 70% or Isopropanol 70% • Cidex OPA TM

• Chlorhexidine/ethanol (e.g. Hibitane

)

TM

• Hypochlorite solution (e.g. Clorox

)

Note: The disinfectants in this list are only approved for cleaning the water trap.

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If the step of rinsing before disinfecting is not included in the washer disinfector program, or if the washer disinfector will not be used immediately, or if manual disinfection is to be performed, then clean and rinse the parts as follows: 1.

Immerse the part in a detergent solution. Ensure they are completely submerged and no air pockets remain.

2.

Fill a large container with water and rinse the parts by immersing the parts for at least 1 minute.

3.

Remove the parts and discard the rinse water. Do not reuse the water for rinsing or any other purpose.

4.

Repeat steps 2-3 twice (a total of 3 times).

5.

Rinse the patient cassette and volume reflector using the cleaning adapters as described in this manual.

2.4.1 Rinsing the patient cassette Use the required cleaning adaptor when rinsing the patient cassette: 1.

Connect the cleaning adapter to fit into the back of the patient cassette.

The following detergents are recommended by the manufacturer: • neodisher MediClean forte If other detergents are used, the manufacturer recommends detergents with a pH ≤ 10.

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2.

Connect the cleaning adapter to a source of running water (flow > 10 l/min) using connective tubing. Let water flow through the cassette for at least one minute.

Flow-i Anesthesia System, User's Manual

3.

Place the patient cassette upside down and again let water flow through the cassette for at least one minute.

4.

Attach the connective tubing to the expiratory connection and let water flow through the cassette for at least one minute. Repeat for the inspiratory connection.

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5.

Remove the cleaning adaptor, carefully shake and tilt the cassette, turn upside down and repeat.

The patient cassette is a precision instrument and must be handled carefully.

2.4.2 Rinsing the volume reflector Connect running water (flow > 10 l/min) to one inlet of the volume reflector and let water flow through for at least 1 minute. Make sure no air pockets remain in the internal compartment. Place the volume reflector standing on its long end according to the illustration.

To empty water from the volume reflector, the following steps are recommended: 1.

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Hold the volume reflector horizontally so that water flows from the two openings into the sink.

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2.

Slowly rotate clockwise (A-D) until the flow of water is minimal. Repeat this step three more times, or until no more water remains. Beware of residual hot water after using a washer-disinfector.

2.5 Disinfection procedures This section describes two independent methods of disinfecting the patient cassette, volume reflector and associated parts: • Automated disinfection in washer-disinfector (recommended) • Manual disinfection by immersion in disinfectant fluid

2.5.1 Washer-Disinfector The washer-disinfector used for thermal disinfection shall have an A0 value of 600 and shall wash at a maximum temperature ranging o o o o from 90 C to 95 C (194 F to 203 F).

2.4.3 Volume reflector adaptor and safety valve Rinse the volume reflector adaptor and safety valve (if removed) under running water for at least one minute.

Flow-i Anesthesia System, User's Manual

The following detergents are recommended by the manufacturer: • neodisher MediClean forte

If other detergents are used, the manufacturer recommends detergents with a pH ≤ 10.

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