Flow c Cleaning and Maintenance Users Manual Rev 01

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Table of contents

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Flow-c Anesthesia System, User's Manual Infologic 1.4

Introduction Routine cleaning Maintenance and service Malignant hyperthermia

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5 7 33 35

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Flow-c Anesthesia System, User's Manual Infologic 1.4

| Introduction | 1 |

1 Introduction The information in this manual is necessary for safe cleaning and maintenance (also known as reprocessing) of the Flow-c anesthesia system. For information on how to operate the system, see the User's Manual. Cleaning practices vary widely among health care institutions and it is therefore not possible to specify procedures that meet all situations nor is the manufacturer responsible for the effectiveness of cleaning procedures carried out by the patient care handler. The manufacturer recommends cleaning the patient cassette once a month. The manufacturer recommends methods that have been validated using the specified equipment and procedures outlined in this manual. Other methods may work but are not covered by the warranty.

1.1 Cleaning accessories and auxiliary equipment 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.

1.2 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 residue should not be allowed to dry onto the devices. Water quality affects cleaning/disinfection. the manufacturer recommends using deionized water for this purpose. The minimum water quality must be equivalent to drinking water.

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

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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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2 Routine cleaning WARNING! A system checkout must always be performed after cleaning of components. See System checkout on page 32.

2.1 General information When the manufacturer's Servo Duo Guard bacterial and viral filter is used, disinfection and/or steam autoclaving of the patient cassette, volume reflector and associated parts is usually not necessary. If no bacterial/viral filter is used, disinfection or steam autoclaving of the patient cassette, volume reflector and associated parts is usually necessary. Other accessories and disposables than those recommended by the manufacturer may alter or modify recommended cleaning procedures.

When bacterial filters are not used, the recommended cleaning procedure includes the following steps: • Disassemble • Wipe off/discard • Disinfect • Dry • Assemble • System checkout The entire system is required to be cleaned as part of the preventive maintenance procedure, see section Preventive Maintenance on page 33. 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.

When bacterial filters are used, the recommended cleaning procedure includes the following steps: • Disassemble • Wipe off/discard • Assemble • System checkout

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There are several disinfection alternatives.

2.2 Preparations and dismantling

• The patient cassette, volume reflector and associated parts may be cleaned and disinfected using a washer-disinfector compliant with ISO 15883-1. This alternative is recommended by the manufacturer. • The parts may be disinfected by a manual disinfection procedure. • The parts may be dried after rinsing and subsequently steam autoclaved.

2.2.1 Remove external appliances

See section Disinfection procedures on page 21. Use only validated processes when steam autoclaving the patient cassette, volume reflector and associated parts. See section Steam autoclaving procedure on page 24.

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CAUTION: The system must not be disassembled further than described in this manual. 1.

Shutdown the system

2.

Disconnect the system from the power and gas supply.

3.

Disconnect any optional equipment from the anesthesia system.

4.

If installed, remove the suction bottle/single use bag and the suction hose. See section Discarding consumables on page 17 for more details.

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5.

Remove the water trap and gas sampling line (A). Discard the water trap or empty any water present in the water trap. Refer to section Discarding consumables on page 17 for more details.

6.

Turn the CO2 absorber locking dial to unlock (A) and then grip the base of the absorber and gently pull out the absorber (B).

Remove patient tubing, Y-piece and manual breathing bag (B). If present, also remove the bacterial/viral filter.

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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 washer-disinfection of the patient cassette. The kit contains the following items:

Item

Description

1

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

2

Rear adapter. Used for washer-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.

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

Open the patient cassette lid by lifting the release catch and pulling the lid gently upwards.

2.

Release the patient cassette locking device.

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3.

To remove the patient cassette, grip the handle between the inspiratory and expiratory connectors and lift the front edge of the cassette until there is an audible click. The cassette can then be pulled outwards.

4.

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

Flow-c Anesthesia System, User's Manual

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

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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).

8.

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

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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).

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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2.2.3 Remove volume reflector

2.

Firmly pull out the volume reflector from the system.

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

Remove the volume reflector adapter (A) and thread it onto a metal stand (B).

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If required, remove the safety valve housing for cleaning. To do this, use a 6 mm Allen key to loosen the restraining screw approx 3-5 mm (A). Remove the housing and thread it onto a metal stand together with the volume reflector adapter (B).

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-based disinfectant. In the case of more contaminated surfaces, the following products have been approved for use: • Alcohol (ethyl or isopropyl alcohol 70%) Wipe the system free of soap and disinfectant residues using a lint-free cloth moistened in water only.

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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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.

2.3.1 Check fan filter 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 and leave to dry in room temperature.

Discard disposable items according to local and environmental regulations.

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2.3.2 Replace suction filter If necessary, replace the bacterial/viral filter of the suction unit. Refer to section Discarding consumables on page 17. 1.

To remove the suction filter, grip both sides of the filter and pull one side outwards and sideways. The filter will then pop out. Dispose according to hospital routines for contaminated waste products.

2.

Attach a new suction filter into the suction outlet and press firmly until the filter clicks in place to ensure that the filter is correctly secured.

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2.3.3 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

Applicable only if used during treatment

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

Disposable CO2 absorber

When exhausted

---

Reusable CO2 absorber (option)

Replace soda lime when exhausted

When refilling the absorber, use gloves, protective glasses and facial protection according to instructions from soda lime manufacturer.

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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.

If required, remove and replace the inspiratory sample filter (A) and expiratory sample filter (B) located in the patient cassette lid.

Discard the disposable CO2 absorber when exhausted. Never open the disposable CO2 absorber. Only use CO2 absorbers approved by the manufacturer. When reprocessing the reusable CO2 absorber, discard exhausted absorbent material and filters according to hospital routines for hazardous material. For disinfection procedures for the reusable absorber, see section Washer-disinfector procedure on page 21.

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.

Do not clean or disinfect the bacterial/viral filter part of the water trap as this might cause irreversible damage to it. 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. Hibitine ) TM • Hypochlorite solution (e.g. Clorox ) Note: The disinfectants in this list are only approved for cleaning the water trap.

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2.4 Clean and rinse before disinfection

2.4.1 Rinsing patient cassette

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.

Use the rear cleaning adapter when rinsing the patient cassette: 1.

Connect the cleaning adapter to the back of the patient cassette. Align the connections of the adapter to the patient cassette and push gently until the adapter clips snap into the locked position.

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.

• 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. Note: If the step of rinsing before disinfecting is not included in the washer disinfection program, or if the washer disinfector will not be used immediately, then clean and rinse the equipment manually according to hospital routines.

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3.

4.

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

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

2.4.2 Rinsing volume reflector Connect running water to one inlet of the volume reflector and let water flow through for at least one 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.

5.

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

Remove the cleaning adapter and carefully tilt and shake the cassette to empty any residual water left inside the patient cassette. Turn the cassette upside down and repeat.

Note: The patient cassette is a precision instrument and must be handled carefully. 20

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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 • Manual disinfection by immersion in disinfectant fluid

2.5.1 Washer-disinfector procedure CAUTION: Water remaining in the patient cassette and volume reflector after a completed washing program may be very hot.

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

To minimize the effect on the environment, the manufacturer recommends only using water when disinfecting the equipment. This is best performed in a washer-disinfector (with A0 value 600), typically at a maximum o o o temperature ranging from 90 C to 95 C (194 F o to 203 F). If detergents are used with the washer-disinfector, the manufacturer recommends detergents with a pH <10. The following detergents are recommended by the manufacturer: • neodisher® MediClean forte

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