x HANDS-ON MODULE 5 CLEANING FLOW-i V3.0
Before cleaning BEFORE CLEANING CLEANING PROCEDURES OVERVIEW Cleaning procedure when a bacterial/viral filter IS used Cleaning procedure when NO bacterial/viral filter is used Dismantle = D method Dismantle Wipe off/discard = D2 method Wipe off/discard Assemble = autoclave method D D2 Rinse System checkout Washerdisinfector or Disinfectant Dry Rinse Steam autoclave Dry Assemble System checkout 3
Before cleaning cont.... BEFORE CLEANING - GENERAL INFORMATION ABOUT HYGIENE Notes: If the CO 2 absorber is bypassed then the absorbent s cidal effect on microorganisms will not be activated MAQUET recommends that a bacterial/viral filter is always connected to the expiratory inlet of the patient cassette to minimize the risk of cross infection. The filter should always be replaced between patients. If a Servo duo guard (or performance equivalent) filter is connected, then it is usually unnecessary to disinfect or steam autoclave the patient cassette, volume reflector and associated parts. However, 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. Water quality affects cleaning/disinfection. MAQUET recommends using deionized water for this purpose. The water quality must never be less than drinking water quality. 4
2 Dismantling procedure Note: Before dismantling, shut down the system and disconnect it from the power and gas supplies..2 REMOVING EXTERNAL APPLIANCES. Remove water trap () and gas sampling line (2). 2. Remove and discard the filter from the expiratory connection (3). Remove filter Remove water trap 3 2 Remove sampling line 3. Remove the suction bottle/single use bag and associated suction hose. 4. Remove filter on the suction unit (4). Note: After each patient the bacterial/viral filter on the suction unit should be checked for signs of moisture or fluid and replaced if necessary. Fluid in the filter will compromise the functionality of the filter and suction unit Hazardous waste Bacterial/viral filters 4 Pull out and insert new (a click must be heard) 5
2 Dismantling procedure cont... 5. Remove patient tubing (5). 6. Remove Y-piece (6). 7. Remove manual breathing bag including tubing (7). Patient tubing 5 Manual breathing bag 7 Y-piece 6 8. Release the CO 2 absorber using the locking switch (8) and remove it (9). Remove absorber 9 8 Locked to Unlocked 6
2 Dismantling procedure cont....3 REMOVING AND DISASSEMBLING PATIENT CASSETTE: Remove the patient cassette from the FLOW-i as follows:. Release the locking device (). Release locking switch 2. Open the cover by: pressing the lid downwards (2) pressing the button on the right (3) pulling out the release catch (4) Press lid downwards 2 Press button 3 4 Pull out the release catch 7
2 Dismantling procedure cont... 3. Remove patient cassette by lifting the cassette upwards and out using the grip located between inspiratory and expiratory connections (5). 5 REMOVING CAPS AND VALVE CAGES FROM PATIENT CASSETTE. Remove caps () and valve cages (2) from inspiratory and expiratory valves. 2 Remove caps (turn counterclockwise) Remove valve cages (turn counter-clockwise) 2. Reattach the caps (3). Re-attach caps (turn clockwise) 3 8
2 Dismantling procedure cont... REMOVING ABSORBER VALVES FROM PATIENT CASSETTE. Turn patient cassette upside down. 2. Remove the 2 absorber valves - first and then 2 () by turning them counter-clockwise, and attach them to a metal framework (2). 2 2 Metal framework 3. Be careful not to damage the expiratory outlet one way valve that is located at the back of the patient cassette (3). Do not remove this valve. 3 4. Place the 2 dismantled valve cages and the 2 absorber valves inside a fine mesh box (4). The absorber valves are first placed onto a metal framework (5). 5. Rinse the ceramic discs as well. Note: The box holds the parts when they are submerged into disinfectant or are placed in the washer-disinfector. Valve cages with ceramic discs 5 4 Absorber valves 9
2 Dismantling procedure cont... PATIENT CASSETTE S FILTERS 6. Newer systems are not equipped with the gas sampling filters array. Do not remove the protective covers replacing the array..4 REMOVING VOLUME REFLECTOR. Remove volume reflector adapter (). 2. Optional: remove safety valve (2) using Allen key and place on a stand (or something similar) (3) together with adapter Note: Cleaning the safety valve is usually not necessary unless special conditions apply; the patient is a carrier of pulmonary contagious agents etc. Volume reflector adapter 2 Safety valve (option) Metal stand (or something similar) 3 0
2 Dismantling procedure cont... 3. Pull out the volume reflector.
3 Wiping off and discarding procedure.5 WIPING OFF. Use a soft lint-free cloth () moistened in soap (ph <0) and water or a mild detergent-based disinfectant (2) to wipe off: Exterior surfaces Patient cassette compartment Volume reflector compartment All removable parts 2 2. Wipe any remaining soap and disinfectant away with a lint-free cloth moistened only in water. 3. Check the fan filter (3) and rinse under water if necessary. Shake out all excess water from the filter. Open the fan filter compartment 3 Checking the filter 2
4 Rinsing before disinfection procedure.6 RINSING PATIENT CASSETTE. Connect cleaning adapter to back of patient cassette (). Cleaning adapter 2. Connect patient cassette to a source of running water using connective tubing (2). 3. Allow water to flow through the cassette for at least one minute (flow >0l/min.) Connective tubing 2 4. Turn patient cassette upside down (3) and let water flow through it for at least one minute. 3 Patient cassette turned upside down (still attached to the tubing and adapter) 3
4 Rinsing before disinfection procedure cont... 5. Attach connective tubing to the expiratory connection (4) and let the water flow through the cassette for at least one minute. 6. Repeat procedure for inspiratory connection. 7. Remove tubing and cleaning adapter. 8. Carefully shake and tilt the cassette. 9. Turn upside down and repeat. 4 Expiratory connection.7 RINSING VOLUME REFLECTOR. Stand the volume reflector on its long side and attach connective tubing to one inlet (), allowing water to flow through for at least one minute. Note: Make sure no air pockets remain in the internal compartment. 2. Rinse the volume reflector adaptor and safety valve (if removed) under running water for at least one minute. 4
5 Disinfection with washer-disinfector procedure (D).8 DISINFECTION WITH WASHER-DISINFECTOR (D) Notes: There are two disinfection procedures for the patient cassette, volume reflector and associated parts (known as D and D2). In D (recommended procedure), a washer-disinfector is used, (with A0 value 600), typically at a maximum temperature ranging from 90 o C to 95 o C (94 o F to 203 o F), a water pressure of <,5 bar and a water flow of >0l/min. If detergents are used with the washer-disinfector, MAQUET recommends detergents with a ph <0: neodisher MediClean forte has been validated: In procedure D2 only a disinfectant is used.. Connect special cleaning adapters to the patient cassette ( and 2). 2 patient cassette (upside down) 5
5 Disinfection with washer-disinfector procedure (D) 3. Connect a washer-disinfector water outlet to the patient end of the volume reflector (upper inlet). 4. Connect the special cleaning adapters to the washer-disinfector water outlet using connective tubings. 2. Place the disassembled parts in the washer-disinfector as suggested in the illustration. 3. To increase washing efficiency, plug remaining water inlets (3) to increase water flow through patient cassette and volume reflector. safety valve patient cassette adapters volume reflector metal stand (or similar) volume reflector adapter volume reflector adapter 3 mesh box plugs on remaining water inlets Note: Be careful as any water remaining in the patient cassette and volume reflector after a completed washing program may be very hot. 6
6 Disinfection with disinfectant procedure (D2).9 DISINFECTION WITH DISINFECTANT (D2). Remove the inspiratory and expiratory valve lids and place them in a fine mesh box () together with the valve cages (2). 2 Valve cages with ceramic discs Absorber valves 2. Lower the parts into the disinfectant fluid and make sure they are completely submerged and no air pockets remain inside. 3. Let the disinfectant act according to manufacturer s instructions - Cidex OPA has been validated. Rinsing after disinfection.0 RINSING AFTER DISINFECTION Notes: Ensure that the cleaning adapters used have been disinfected according to either the D or the D2 disinfection procedure. Use deionized water when rinsing after disinfection to avoid mineral scale build-up. Remove all traces of disinfectant by rinsing the parts thoroughly in water according to the instructions described under Rinsing before disinfection procedure Take care to rinse the inspiratory and expiratory valve screwthreads and lids thoroughly before attaching the lids back onto the patient cassette. Before proceeding to Drying procedures make sure as little water as possible remains in the patient cassette and volume reflector and also check for residuals on the equipment. 7
7 Steam autoclaving procedure. STEAM AUTOCLAVING PROCEDURE Notes: Before autoclaving the equipment must be rinsed and dried (see Rinsing procedure and Drying procedure for details). This is important as any water remaining in the patient cassette can prevent complete energy transfer from the hot steam which will result in an incomplete process. System parts should be autoclaved in a validated process.. Position the parts inside the autoclaving unit as shown in the illustration. Patient cassette Mesh box Volume reflector adapter Safety valve Volume reflector Notes: System parts are typically autoclaved at a temperature of 2 C (250 F) for 5 minutes or 34 C (275 F) for 4-7 minutes. The system parts can also be autoclaved at a temperature of 34 C (275 F) for 8 minutes, (i.e. using the Prion autoclave program) However, using this method will further reduce the lifetime of the parts. The manual breathing bag and suction bottles should be autoclaved according to the manufacturer's instructions. 8
8 Drying procedures.2 DRYING PROCEDURES Note: The patient cassette, volume reflector and associated parts, must be dried before use. If the assembled system parts are not dry, the System checkout may fail. Drying may not be necessary, or the drying time may be reduced, if the washer-disinfector has a drying phase. Before employing the drying procedures described below, remove as much visible water as possible by shaking and tilting the parts. REMOVING WATER FROM THE VOLUME REFLECTOR. Hold the volume reflector horizontally and tilt the device so that water flows from the two openings into the sink (). 9
8 Drying procedures cont... 2. Hold the volume reflector vertically, with the top (smooth) side facing you. Slowly rotate clockwise at least four times until the flow of water is minimal (2, 3 and 4). 2 Note: Take care as there may be residues of hot water in the volume reflector if the equipment has been cleaned using a washer-disinfector 3 4 3. Visually check for residual water in the channels by holding the volume reflector in front of a light source. 20
8 Drying procedures cont... USING A DRYING CABINET. Disconnect the cleaning adapters from the patient cassette ( and 2). 2 patient cassette (upside down) 2. Place the patient cassette, volume reflector and associated parts in a drying cabinet (see illustration). 3. Connect a 22 mm air hose () to the expiratory outlet of the patient cassette (2) for extra drying capacity. 22 mm air hoses 2 2
8 Drying procedures cont... Notes: All parts (minimum of.5 hrs max. temperature 90 o C (94 o F). Volume reflector time (2.5 hrs if manually disinfected and rinsed). Volume reflector pressure (max. 0.3 bar). FORCED VENTILATION (OPTIONAL). Assemble the system as described under Assembly procedure. 2. Ventilate using a MAQUET test lung that is attached to the Y-piece for 5 minutes. In Volume Control ventilation mode, set a minute volume of at least 0 l/min. Note: Forced ventilation should not be considered a stand alone procedure for drying the system equipment. It acts as a complement to the drying cabinet only. 22
9 Assembly procedure.3 ASSEMBLY PROCEDURE Notes: Prior to assembly, make sure all parts are dry, free from dust and other particles and are at room temperature. Thoroughly inspect all removed parts for cracks, deformities, fissures and other material wear and replace if necessary. ASSEMBLY OF VOLUME REFLECTOR. When the volume reflector adapter has been removed, you can check that the lever in the cassette compartment () is correctly positioned (see illustration) 2. It will now be possible to re-insert the volume reflector (2). Lever 2 3. Plug in the volume reflector adaptor (3) and remount the safety valve (if removed) (4). 4 3 23
9 Assembly procedure cont... ASSEMBLY OF PATIENT CASSETTE. Re-position the valve cages that hold the ceramic plates () into the inspiratory and expiratory valves. 2. Check for damage and material wear. Caps Valve cages with ceramic discs 3. Turn patient cassette upside down. 4. Remount absorber valve (turning clockwise). 5. Remount absorber valve 2 (turning clockwise). 6. Ensure that the expiratory outlet s one-way valve on the patient cassette (2) covers the opening completely and functions correctly. expiratory outlet one-way valve 2 back view 24
9 Assembly procedure cont... 7. Reinsert the patient cassette by placing the back of the cassette onto the mounting rails and then press firmly down and forwards (3). 3 8. Press in the button on the right (4). 9. Open the release catch (5). 0. Press the lid down until it locks into position (6).. Tighten the patient cassette locking device (7). Press down and forwards 5 6 4 7 Locking device 25
9 Assembly procedure cont... RECONNECTING THE ABSORBER. Reconnect the CO 2 absorber ( and 2) 2 RECONNECTING THE PATIENT TUBING. Attach a new bacterial/viral filter to the expiratory connection (). new filter patient tubing 2 2. Attach a new bacterial/viral filter to the suction unit (see Dismantling procedure ). 3. Reconnect suction bottle/single use bag and suction hose. manual breathing bag 4 Y-piece 3 4. Attach patient tubing (2), Y-piece (3) and manual breathing bag (4). 26
9 Assembly procedure cont... Attach water trap and gas sampling line (5). Important: After cleaning always perform a System checkout see MX0867 System checkout and Emergency ventilation" water trap and sampling line 5 27
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Legal manufacturer: Maquet Critical Care AB Röntgenvägen 2 SE-7 54 Solna, Sweden Phone: +46 (0) 8 730 73 00 www.maquet.com Maquet Critical Care AB 204. All rights reserved. MAQUET reserves the right to modify the design and specifications contained herein without prior notice. Order No. MX-0869 Rev: 03 English, MCV00026875 REVA HANDS-ON MODULE 5 Printed in Sweden 4040 US Sales contact: MAQUET Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 www.maquetusa.com CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician. Refer to Instructions for Use for current Indications, warnings, contraindications, and precautions. For local contact outside US: Please visit our website www.maquet.com MCV order number is valid for US MX order number is valid outside US GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care.