MEDAP FINA Air B 800 Operating Instruction Ver 08 Sept 2004

MAQUET

Entnahmegerät FINA AIR B 800

Contents 1. Notes for safe operation ... 25 1.1. Notes for user ... 25 1.2. Note on guarantee ... 25 1.3. Applicable standards and guidelines ... 25 1.4. Checking the contents ... 25 1.5. Pictograms used in the operating instructions ... 26 1.6. Pictograms used on the suction controller ... 26 1.7. Intended usage / purpose ... 26 1.8. Incorrect operation / Contra-indications ... 27 1.9. Description of interface ... 27 2. What is what? ... 28 2.1. Components ... 29 2.2. Description of controller and its function ... 29 3. Commissioning ... 30 3.1. Safety notes ... 30 3.2. Checking the controller ... 30 3.3. Assembling and connection ... 31 3.3.1. Fitting the vacuum meter ... 31 3.3.2. Connecting the controller to the terminal unit ... 32 3.3.3. Connecting the receiver jar and the applicator ... 34 3.4. Function testing ... 36 4. Operation ... 37 4.1. Working with the controller ... 37 5. Taking out of operation ... 38 6. Malfunctions ... 39 6.1. Troubleshooting table ... 39 7. Cleaning and Disinfection ... 40 7.1. Safety notes ... 40 7.2. Cleaning the components of the controller ... 40 7.3. Disinfection ... 40 8. Maintenance / Repair ... 42 8.1. Maintenance ... 42 8.2. Inspection / Repair ... 42 9. Supply programme ... 43 9.1. Accessories / spare parts ... 43 10. Disposal ... 44 11. Technical Data ... 45

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MAQUET 1. Notes for safe operation 1.1. Notes for user Please ensure that the use of the suction controller is restricted to appropriately qualified staff. These Operating Instructions are intended for medical staff who • have acquired their knowledge by specialist training, • are able to judge their actions on the basis of professional experience and knowledge of the relevant safety regulations, • can recognise and react to potential dangers.

1.2. Note on guarantee The manufacturer can only accept responsibility for the safety, reliability and functioning of the apparatus when: • Only original spare or replacement parts are used. • Repairs to the controller are only made by staff authorised by the manufacturer. Warning! This unit may be operated only by persons trained in its use, in accordance with this instruction manual. This instruction manual applies only to units designated REF 5752 1729 - 5752 1732, REF 5752 1734 , REF 5752 1735, REF 5752 1756, REF 5752 2594 and REF 5752 3360.

Suction controller FINA AIR B 800

1.3. Applicable standards and guidelines DIN EN 837-1: 1997-02 Preasure guages - Part 1: Bourdon tube pressure gauges; Dimensions, metrology, requirements and testing. DIN EN 739: 1998-02 Low pressure hose assemblies for use with medical gases. DIN EN ISO 10079-3: 2000-03 Medical suction apparatus Part 3: Suction equipment powered from vacuum or pressure sources. DIN EN 12218: 1998-12 Rail systems for supporting medical equipment. DIN 13260-2: 2004-06 Medical gas supply systems. Part 2: Terminal units for medical gases and vacuum; specifications, testing. DIN EN ISO 14971: 2001-3 Medical products – Application of risk management to medical devices. DIN V ENV 737-6: 2003-6 Pipeline systems for medical gases and vacuum. Part 6: Dimensions and arrangements for compressed medical gases and vacuum. Connector dimensions: MEDAP standard company-specific version ( published ) BS 5682 British plugs NFS 90116 French plugs SS 87 524 30 Swedish plugs DIN 13260-2 German plugs DIN V ENV 737-6 European plugs

1.4. Checking the contents When the controller is delivered, check that all components are included and are in perfect condition. Please address any complaints to your supplier.

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MAQUET 1.5. Pictograms used in the operating instructions The following pictograms are used in these operating instructions: Warning! Non-compliance can result in severe or even fatal injury. Caution! Non-compliance can result in slight to moderate injury or material damage. Note! Tips for use and useful information.

1.6. Pictograms used on the suction controller The following pictograms are used on the suction controller As with operating instructions >PA< 0123

Identifies the plastic material CE-symbol and number of the authorised office as in the Medical Product Guidelines 93/42/EEC

1.7. Intended use / purpose The suction controller is suitable for continuous operation, with high flow and high vacuum. It may only be used in combination with a receiver jar for the collection of the aspirated fluids. The controller may only be operated by trained specialist staff. • The controller is intended for use in clinics and doctors' surgeries. It is used to aspirate secrete, blood, vomit or serous liquids and is especially suitable for bronchial aspiration (nasal or oral aspiration). • For compressed air operation, the suction controller is connected to a central gas supply system (CSS) with a pressure of 5 bar ± 10%.

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Suction controller FINA AIR B 800

Warning! The medical gas supply system must be equipped with a device to warn of incorrect operating pressures. Caution, overflow! To prevent liquid entering the suction controller, the controller may only be used with an overflow protection and / or hydrophobe filter and a receiver jar. Connection of the suction controller to the gas terminal unit is dependant on the type of controller. Version A: Direct controller • The controller is connected directly to the terminal unit. Version B: Remote controller with equipment rail clamp • The controller is mounted on a 25 x 10 mm rail and is supplied from a terminal unit by a hose and gas probe. Version C: Remote controller with equipment mount. • The controller is fitted with an equipment mount to DIN EN 12218 and is supplied from a terminal unit by a hose and gas probe. All versions: • All components of the suction controller, except the bacteria filter paper and sound absorber inserts, are reusable after cleaning/ disinfecting/ sterilising. • Only those accessories or parts which are approved by Maquet may be used in conjunction with the suction controller. Warning, Controller malfunction! The use of incorrect accessories or parts can lead to personal injury or to a malfunction.

MAQUET 1.8. Incorrect operation / Contraindications Warning! The suction controller is not suitable for vacuum extraction. Warning! The suction controller is not suitable for drainage and should not be used in the fields of paediatrics and neonatology. • The controller must not be thrown, hit or dropped. • The controller must not be operated without an overflow protection. • The overflow jar must not be used as a receiver jar and must not come into contact with strong alkalis or acids. • The controller must not be held or handled by the vacuum meter. • The vacuum meter is not autoclaveable. • When stored, the controller should be protected from damage, e.g. wrapped in cloths or similar.

1.9. Description of interface Attention, Controller malfunction! The use of incorrect parts can lead to personal injury or to a controller malfunction. g Only use original accessories and spare parts. All devices or accessories which are combined with the suction controller must be included in the list of accessories or comply with the conditions of the following interface description. The configuration of the whole system and checking its proper operation is part of the overall responsibility of the medical staff. The function and the suitability of the connected accessory for an intended purpose must be chekked by the user before each use. This includes the functionality of the connectors, air tightness and suitability with regard to material properties, working pressure and flow.

Suction controller FINA AIR B 800

• Intermediate tube (connecting suction controller and receiver jar): Vacuum tube, internal diameter 6 to 8 mm; length 50 cm (± 10 cm); must not collapse at a vacuum of –0.95 bar and must be either sterilisable or a sterilised disposable article. • Mechanical overflow protection or hydrophobe watertight filter: Tube nipple accepting the intermediate tube; filter pore size max. 1µm; check direction of flow. • Receiver jar incl. lid: Low leakage; Volumes 0.7 – 5.0 l; the outer diameter of the tube nipple on the vacuum source must match the internal diameter of the intermediate tube, the receiver jar must be securely fixed in a the holder or on the equipment rail. • Aspiration tube (connecting the receiver jar – applicator): Vacuum tube (1.3 m – 3.0 m length) must not collapse; must be sterilisable or be a sterilised disposable article; the external diameter of the patientside tube nipple on the receiver jar must match the internal diameter of the aspiration tube. • Applicator (lancet, cannule, etc.): The outer diameter of the connection on the applicator must match the inner diameter of the aspiration tube; Applicators must be sterilisable or be sterilised disposable articles. Warning! The functionality and suitability of the applicators for the purpose, and their bio-compatibility must be checked by the user.

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MAQUET 2. What is what? Fig. 1

Version B

Version A

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Suction controller FINA AIR B 800

Version C

MAQUET

Suction controller FINA AIR B 800

2.1. Components

2.2. Description of controller and its function

Basic controller: 1 Shut-off valve 2 NIST- body 3 Connection nipple 4 Bacteria filter housing 5 Regulating valve 6 Body 7 Vacuum meter

The suction controller is supplied from a central supply system (CSS) with compressed air. The gas jet pump is powered by the compressed air and produces the required vacuum. For this purpose, the suction controller in

Media connection: 2 NIST body 8 NIST-Nippel 9 Nut A Connecting hose B Probe C Terminal unit D Equipment rail E Equipment mount holder F Equipment mount G Rail clamp H Spring lever Connection to receiver jar: I Mechanical overflow protection J Mechanical overflow protection nipple K Silicone vacuum tube (intermediate tube A) L Silicone vacuum tube (intermediate tube B) M Hydrophobe filter, watertight Safety device: N Safety valve

Version A: Direct controller • is coupled directly to the respective terminal unit C of the CSS. Version B: Remote controller with equipment rail clamp • is clamped to an equipment rail D with a 25 x 10 mm profile. A connection hose A with NIST nut 9 is screwed on to the NIST body 2 of the con-troller and the probe B is plugged into the respective terminal unit C of the CSS. Version C: Remote controller with equipment mount • is located in an equipment mount holder E. Here too a connection hose A with NIST nut 9 is screwed on to the NIST body 2 and the probe B is plugged into the respective terminal unit C of the CSS. With the shut-off valve 1 the compressed airsupply can be opened or closed. The vacuum is set with the regulator valve 5 and read on the vacuum meter 7. The exhaust air is blown into the room through the bacteria filter 4. If a malfunction occurs, a safety valve N prevents over pressure build up on the patient side. A mechanical overflow protection I / watertight hydrophobe filter M, protects the controller from an overflow. Over the connection nipples (3 / J) the connection to the receiving jar can be made.

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MAQUET 3. Commissioning 3.1. Safety notes Warning, Observe hygiene guidelines! Contaminated parts can endanger the patients' health. g Prepare the controller as recommended in the hygiene guidelines, before Commissioning. g Clean and disinfect the controller. Caution, Overflow! Only operate the suction controller with an overflow protection. Otherwise the controller is not protected against over flow. Caution, Overflow! The suction controller may only be operated in a vertical position with the mechanical overflow protection. Caution, Receiver jar! Only use the controller in conjunction with a receiver jar. Caution, Vacuum meter! Caution, Do not subject the vacuum meter to any shocks, the sensitive, fine mechanical components can be damaged. Caution, accuracy of measurement! The controller may only be operated in a vertical position.

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Suction controller FINA AIR B 800

3.2. Checking the controller Warning, Checking the controller! Proper functioning of the suction controller is only ensured by components in perfect condition. Before assembly, the components must be given a thorough examination. g Check that all tubes are undamaged. g Check that the shut-off valve operates properly. g Check that the controller has been properly cleaned and that there are no residues or soiling. g Damaged parts may not be used.

MAQUET

Suction controller FINA AIR B 800

3.3. Assembling and connection

Fig. 2

3.3.1. Fitting the vacuum meter (Fig.2) • Push the vacuum meter into the controller housing, turned sideways through 90° and press downwards to stop. To lock the vacuum meter, turn back through 90°.

Vertical vacuum meter

3.3.2. Inserting the bacteria filter paper • Screw off the bacteria filter cap O and place the bacteria filter paper P into the filter cap. The side with the fine structure must face the gas jet pump Q. • Screw the bacteria filter cap O back on. Caution, Hygiene! The bacteria filter paper should be changed after 48 hours' use.The bacteria filter paper and the sound absorber insert must be changed immediately if the performance of the suction controller reduces. • Used bacteria filters papers and sound absorber inserts are to be disposed of in accordance with hygiene guidelines. Horizontal vacuum meter Fig. 3

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MAQUET 3.3.2. Connecting the controller to the terminal unit (Fig. 4): All Versions:

Suction controller FINA AIR B 800

Fig. 4 Version A

Note! Connect the gas probe to the terminal unit in accordance with the manufacturers instructions Version A: Direct controller • Push the probe B directly into the terminal unit C. Version B: Remote controller with equipment rail clamp • Locate the rail clamp G at a slight angle with the upper edge fully over the rail, press flat against the rail D and the spring lever engages. • Ensure that the controller rail clamp G is properly and firmly located on the equipment rail D. The spring lever H must be flush with the clamp. • Push the NIST nipple 8 of the connection hose A into the NIST body 2 on the controller and tighten the NIST nut 9. • Press the connection hose A probe B into its respective terminal unit C.

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Version B

MAQUET Version C: Suction controller with equipment mount • Locate the equipment mount F in the equipment mount holder E and lock.

Suction controller FINA AIR B 800

Fig. 4 Version C

Note! Please find instructions on operation of the equipment mount holder in the manufacturer's documents. • Ensure that the equipment mount F is fully inserted in the holder E and the suction controller sits securely in the equipment mount holder E. • Push the NIST nipple 8 of the connection hose A into the NIST body 2 on the suction controller and tighten the NIST nut 9. • Press the probe B of the connection hose A into the relevant terminal unit C.

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MAQUET 3.3.3. Connecting the receiver jar and the applicator Caution, Overflow protection! If the receiver jar to be connected does not have an integrated overflow protection, connection to the suction controller may only be made with an intermediate overflow protection and/ or a hydrophobe watertight filter, (accessory). Caution, Configuration of the applicator! The design of the applicator is crucial for the proper functioning of the controller. An unsuitable applicator can reduce the performance of the controller or even prevent it from operating. g All applicators or accessories connected to the controller, must either be included in the list of accessories or meet the conditions in the interface description (see 1.9). Caution, Accessory! No mechanical force must be exerted by the accessory which could impair the firm sit of the controller. Caution, Assembly or dismantling force! When assembling or dismantling an accessory to the controller, the controller must be firmly held with one hand, to compensate for the occurring forces.

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Suction controller FINA AIR B 800

MAQUET Connecting an overflow protection (Fig. 5a): 1. Locate the overflow protection I directly on to the connection nipple 3 on the controller housing and press upwards to the stop. 2. Press the intermediate tube A K on to the tube nipple J of the overflow protection and connect to the tube nipple on the receiver jar. 3. To dismantle, first remove the intermediate tube A K from the tube nipple J of the overflow protection I. Then pull the overflow protection, complete with cover, off the connection nipple 3 of the controller. While doing this, hold the controller firmly with one hand. Connecting a watertight hydrophobe filter, (Fig. 5b): 1. Press the intermediate tubes A K and B L on to the two tube nipples of the filter M. 2. Determine the flow direction of the filter. The inlet side must be towards the patient, the outlet side towards the controller. 3. Then press the intermediate tube A K on to the connection nipple 3 on the controller housing. 4. Connect the intermediate tube B L with tube nipple on the secretion jar

Suction controller FINA AIR B 800

Abb. 5a

Abb. 5b

Connection of a receiver jar with integrated overflow protection (Fig. 5c): • Press the intermediate tube A K on to the connection nipple 3 on the underside of the controller housing and connect to the tube nipple of the receiver jar. Note!

Abb. 5c

Please find further instructions for the correct use of the receiver jar and the applicators in the relevant manufacturer's instructions.

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MAQUET 3.4. Function testing Warning, Function testing! The suction controller is used in the treatment of patients. Reduced performance can lead to complications in the treatment. Before use, the suction controller must be given a full function check. Ensure that, with Version A: Direct controller • The suction controller is directly and fully connected to the terminal unit. Version B: Remote controller with equipment rail clamp • The suction controller is firmly mounted on the equipment rail. Version C: Remote controller with equipment mount • The suction controller is inserted securely into the equipment mount holder. All Versions: • The shut-off valve functions properly; • The overflow protection and / or hydrophobe filter is fitted and functioning and there are no residues in them; • A bacteria filter paper is inserted; • The tube connections are all securely connected, with no leakage and there are no mechanical forces acting on the tubes; • Plastic and rubber components are in perfect condition and show no signs of aging; • A receiver jar is connected to the suction controller. Note! Connecting several receiver jars in series will delay the vacuum build up and can reduce the displacement flow.

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Suction controller FINA AIR B 800

Caution, Foaming! When aspirating fluids, foam may form. Foam can affect the function of the overflow protection. g Use a commercial foam inhibitor. g To operate, open the shut-off valve.

MAQUET 4. Operation 4.1. Working with the controller

Suction controller FINA AIR B 800

Fig. 6

Set the required vacuum for the treatment (Fig. 6): 1. To operate, open the shut-off valve 1 fully. To do this, turn the wing nut through 90°, so that it lines up with the gas inlet. 2. Open the regulator valve 5 one complete turn anticlockwise. 3. Kink the hose A K leading to the receiver jar and read on the vacuum meter 7 whether the controller has produced vacuum. If the vacuum is too low, look for the possible cause in the troubleshooting table. 4. Set the vacuum required for the treatment with the regulator valve 5: - Increase vacuum: Turn regulator valve anticlockwise. - Reduce vacuum: Turn regulator valve clockwise.

Note! Re-check vacuum setting immediately prior to use. Caution, Overflow protection! If the overflow protection closes during use, the overflow protection, complete with cover, must be removed and a new overflow protection fitted as described in Point 3.3.

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MAQUET 5. Taking out of operation • Close the shut-off valve 1 and the regulator valve 5. • Pull the intermediate tube K / L and the overflow protection (overflow protection I or filter M ) off the suction controller and the receiver jar and process or dispose of them. • Remove the probe B from the terminal unit C. Note! Uncouple the probe from the terminal unit according to the manufacturer´s instructions. Version B: Suction controller with equipment rail clamp • Remove the controller from the equipment rail D. To do this, pull the spring lever H back and lift the controller off the rail D. Version C: Suction controller with equipment mount • Remove the controller from the equipment mount holder E.

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Suction controller FINA AIR B 800

MAQUET

Suction controller FINA AIR B 800

6. Malfunctions 6.1. Troubleshooting table Attention, Controller malfunction!

Defect

• No / low vacuum • No or reduced flow • Regulation not possible

Vacuum meter doesn't fit

The use of incorrect spare parts can lead to personal injury or to a controller malfunction. g Only use original spare parts.

Reason Shut-off valve closed No vacuum meter connected

Corrective action Open shut-off valve Fit vacuum meter as instructed

Intermediate tube not connected to suction controller

Connect intermediate tube as instructed

Intermediate tube too long Tubes collapse

Shorten tube to 50 cm max length Use specified tubes (to – 0.95 bar)

Receiver jar full, overflow protection closed

Empty/ change receiver jar, change overflow protection

Hydrophobe filter blocked Damaged seals / gaskets Vacuum system leaking Shut-off valve defective Central supply system failure Probe connections loose Vacuum meter defective Gas jet pump defective Regulator valve defective

Change hydrophobe filter Change seals / gaskets Check vacuum system

Problems by the insertion of the vacuum meter into the controller with the scale to the front.

Call technical services

Always insert vacuum meter rotated through 90° and then rotate forwards

Select vacuum meter for the correct Wrong vacuum meter for the controller vacuum range (see model plate), vacuum range Connections are coded.

Despite protection Suction controller not vertical device, the controller is Overflow protection dirt overflowed No foam inhibitor used Probe doesn't fit Selected terminal unit is for another into terminal unit gas

Only operate with the controller vertical Clean overflow protection Use commercial foam inhibitor Check type of gas and connect to correct terminal unit

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MAQUET

Suction controller FINA AIR B 800

7. Cleaning and Disinfection 7.1. Safety notes Warning, Danger to Health! Parts of the remote controller may be contaminated. There is a risk of infection. Protect your health. g By preparation and when cleaning, be sure to observe the hygiene guidelines. Warning, Danger to Patients! Suction controllers will not function after an over flow. If the controller is not properly cleaned after an overflow, there is considerable risk to the patient, since safety devices could be sticky. g Controllers which have suffered from an overflow must be inspected and repaired by the Technical Service.

7.2. Cleaning the components of the controller The controller must be cleaned before disinfection or sterilisation.

• Dry the controller parts immediately to prevent the colonisation of germs on the surfaces. • After each use, check that the controller parts function correctly (see Point 3.4.).

7.3. Disinfection Warning, Danger of injury! Disinfectants may contain substances hazardous to health, which can cause injury on contact with skin and eyes. g Protect your skin and eyes and be sure to comply with the hygiene guidelines when working with disinfectants. • Observe the instructions of the disinfectant manufacturer and the hygiene specialist. • fter disinfection in a solution, rinse the controller parts with water and then dry well. • After every disinfection, check the proper functioning of the controller. Caution, Damage to controller!

Caution, Material damage! Some components of the suction controller are made of plastic materials. Solvents, some disinfectants or cleaners can attack plastic parts or can cause stress cracking . g Do not use solvents containing hydrocarbons to clean the surfaces. g Do not bring the overflow jar into contact with strong acids or alkalis. Note! Dirt particles or fluid droplets may become encapsulated and cause parts of the controller to not be sterile after sterilisation. If the controller has had an overflow, or if the float has been activated, fluid droplets may have entered the overflow protection. • Clean the parts of the controller thoroughly and remove obstinate dirt with a cloth and cleaning agent. • Rinse cleaned parts thoroughly. 40

Do not use an alcoholic disinfectant. There is the risk of stress cracking. Caution, Material changes! Sterilising with hot steam accelerates the natural aging of plastics. The function of the controller components may be impaired. g Check the controller function after every cleaning. Please find the recommended disinfection procedures in the following table.

MAQUET

Suction controller FINA AIR B 800

Disinfection processes for the suction controller

Suction controller components, see Fig. 1

Suction controller housing3

In solution1

Wipe and spray disinfection

X

X

Vacuum meter

X

Connection hose with NISTnipple and nut

X

Overflow protection4

X

X

Autoclaveable with hot steam up to 134° C2

X

1

Take care to rinse well and then dry. Attention, sterilising with hot steam accelerates the natural aging of plastics! 3 The connection hose with NIST connector should be unscrewed from the suction controller (Versions B and C). 4 Unscrew the jar and lid. 2

Note! If wrapping cloths used by autoclaving are not colour-fast, plastic parts may become dicoloured. Note! The jar of the overflow protection is a consumable item. Dependent on the cleaning methods the material can wear out. Before every use check the jar for signs of wear. If damage to the jar is found exchange the jar.

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MAQUET 8. Maintenance / Repair 8.1. Maintenance Warning, Controller malfunction! The use of incorrect spare parts can lead to personal injury or to a malfunction of the controller. g Only use original spare parts. Warning, Function testing! The suction controller is used for patient treatment. Reduction in performance can lead to complications during the treatment. g After preparing the suction controller, check each time that it is working properly. No maintenance work is necessary on the controller, beyond the usual regular care by the staff using it. Caution, Inspection! The controller function and the accuracy of the vacuum meter must be checked at least once a year by authorised specialist staff in accordance with Instruction 56351342. If deviations are found in the accuracy of the display, the controller must be sent for repair.

8.2. Inspection / Repair Warning, Danger to Health! The suction controller is used for treating patients. The controller, or parts of it, may be contaminated. g Clean and disinfect the controller before sending it back for inspection or repair. Repair work may be carried out by staff trained by us. Guarantee exclusion! BNo responsibility can be accepted after work has been carried out by unauthorised persons.

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Suction controller FINA AIR B 800

Service address: See back of operating instructions.