BOY SX, JuniorBOY SX and TurboBOT SX Instructions for Use Aug 2017

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Gebrauchsanweisung ...

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Instructions for use ...

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en Instructions for use Information as of: April 2017. All rights reserved. Technical and design changes and printing errors reserved. Principle shown in illustrations.

IMPORTANT INFORMATION... General... Information about the instructions for use ... Structure of safety instructions ... Using the compressor ... Treatment of babies, children and anyone who requires assistance ...

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PRODUCT DESCRIPTION ... Components ... Intended purpose ... Intended use... Contraindications... Product variants and combinations ... Working parts ... Operating life ...

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PREPARATION FOR USE ... Setting up the compressor ... Preparing the treatment... Performing treatment... Ending the treatment ...

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MAINTENANCE ... Cleaning ... Replacing the filter... Repairing ... Storage ...

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TROUBLESHOOTING ...

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TECHNICAL DATA... General compressor data ... Classification according to DIN EN 60601-1 ... Information about electromagnetic compatibility ... Ambient conditions ...

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MISCELLANEOUS ... Disposal... Terms and conditions of warranty ... Explanation of symbols ... Contact ...

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1

IMPORTANT INFORMATION

1.1 General Please read these instructions for use carefully and completely. Do not discard, so you can consult them at a later date. If you fail to comply with the instructions for use, injury or damage to the device cannot be ruled out. In addition, follow the instructions for use of the nebuliser and the accessories that are being used.

1.2 Information about the instructions for use If these instructions for use are lost, you can request another copy from PARI GmbH [see: Contact, page 50]. The instructions for use for some products can be retrieved on the internet in both German and English. Simply visit: www.pari.com (on the respective product page).

1.3 Structure of safety instructions Safety-critical warnings are categorised according to hazard levels in these instructions for use: – The signal word WARNING is used to indicate hazards which, without precautionary measures, can result in serious injury or even death. – The signal word CAUTION is used to indicate hazards which, without precautionary measures, can result in minor to moderate injury or impair treatment. – The signal word NOTICE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

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1.4 Using the compressor The compressor is an electrical device that is powered by supply voltage. It has been designed so that no live parts are accessible. However, if ambient conditions are unfavourable or if the compressor or power cord is damaged, this protection may no longer be assured. Therefore, please follow the instructions below to avoid damage to the device and the associated danger of contact with live parts (e.g., electric shock): – The compressor is not splashproof. Protect the device and the power cord from liquid and moisture. Never handle the device, the power cord or the power plug with damp hands. In addition, the device must not be operated in a damp environment. – Only use the PARI power cord to operate the compressor. – Make sure that the local supply voltage complies with the voltage data marked on the compressor identification label. – Never leave the compressor unattended while it is in use. – For safety reasons, always disconnect the power plug from the socket under the following circumstances: – if a malfunction occurs during operation – before cleaning and maintaining the device – immediately after use – Always pull the power plug, not the cable, to disconnect the power cord from the socket. – Make sure that the power cord is never kinked, pinched or jammed. Do not pull the power cord over sharp edges. – Keep the compressor and the power cord away from hot surfaces (e.g., stove top, electric fire, open fire). Direct heat may damage the compressor housing or the power cord insulation. – Keep the power cord away from domestic animals (e.g., rodents). They may damage the power cord insulation.

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– The compressor must not be operated and/or the power plug must be unplugged from the socket immediately if the compressor or the power cord is damaged, or if a fault is suspected after the device has been dropped or suffered a similar shock.

1.5 Treatment of babies, children and anyone who requires assistance Babies, children and anyone who requires assistance must be supervised constantly by an adult during inhalation therapy. This is the only way to ensure safe and effective treatment. Such persons often underestimate the hazards involved (e.g., strangulation with the power cord or the connection tube), thus resulting in a risk of injury. The product contains small parts. Small parts can block the airways and lead to a choking hazard. Therefore, make sure that you always keep the compressor, the nebuliser and the accessories out of the reach of babies and infants. The device and the connection tube at the compressor outlet can become very warm during normal operation. Therefore, particularly with individuals who require special assistance, ensure that the user's skin does not come into contact with the compressor. Prolonged contact may cause burns, particularly for patients with impaired temperature perception.

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PRODUCT DESCRIPTION

2.1 Components Check that all of the components belonging to your compressor are included in the package. If anything is missing, please notify the dealer from whom you purchased the PARI compressor immediately.

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(1)

Compressor

(2)

Power cord

1

2.2 Intended purpose The purpose of the compressor is to generate compressed air for operating a PARI nebuliser.

2.3 Intended use The compressor must only be used for PARI nebulisers. It is intended exclusively for indoor use and can be operated by the patient himself/herself. Only original PARI nebulisers and PARI accessories must be used.

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2.4 Contraindications There are no contraindications known to PARI GmbH.

2.5 Product variants and combinations There are several different versions of the PARI BOY SX compressor: – PARI JuniorBOY SX (compressor coloured yellow) – PARI TurboBOY SX (compressor coloured blue) – PARI BOY SX (compressor coloured blue) The compressor is intended for operation with a PARI nebuliser. Separate instructions for use accompany all nebulisers, whether they are included in the basic equipment or purchased subsequently.

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2.6 Working parts The compressor includes the following working parts:

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3

5

10

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8

7

(3)

Carrying handle

(4)

Power cord socket

(5)

Ventilation slits

(6)

Holder for nebuliser

(7)

On/off switch

(8)

Identification label (bottom of device)

(9)

Air outlet

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(10) Filter

2.7 Operating life The compressor has an average expected operating life of: – approx. 1,000 operating hours – max. 5 to 6 years

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PREPARATION FOR USE

3.1 Setting up the compressor WARNING Risk of fire due to a short circuit A short circuit in the device can cause a fire. In order to reduce the risk of fire in such an event, follow the instructions below: • Do not operate the compressor close to readily flammable objects such as curtains, tablecloths, or paper. • Do not operate the compressor in areas where there is a risk of explosion or in the presence of oxidising gases (e.g., oxygen, nitrous oxide, flammable anaesthetics). CAUTION Quality of treatment impaired by electromagnetic interference Electrical devices can cause electromagnetic interference. Interference can impair the function of the devices and thus also the effectiveness of the treatment. • Do not place the PARI device immediately beside or on top of other devices. • Keep at a minimum distance of 30 cm from portable wireless communication devices (including accessories therefor, such as antenna cables or external antennas).

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CAUTION Risk of injury from tripping or caused by the device falling A compressor placed in a poor position or for which the cables are routed untidily poses a risk of injury. • Route the power cord in such a way that it is not a tripping hazard and no one can become entangled in it. • Do not place the compressor above head height and make sure that it cannot be pulled down by the power cord or the connection tube. NOTICE Danger of device fault caused by falling If the compressor falls, it may be damaged so badly inside and outside that it is no longer usable. • Place the compressor on a firm, flat, dry surface. A soft base such as a sofa, a bed or tablecloth is not suitable. NOTICE Danger of device fault caused by dust If the device is operated in a very dusty atmosphere, more dust may collect inside the housing and cause a fault in the device . • Do not operate the compressor on the floor, under the bed or in workshops. • Only operate the compressor in a low-dust environment. The room in which the compressor is operated must satisfy certain conditions [see: Operation, page 46]. The compressor is not intended for outdoor use.

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3.2 Preparing the treatment WARNING Danger of death by electrocution from a faulty device! If the device has a fault, a person may come into contact with live parts, resulting in the danger of electric shock, for example. • Check the compressor housing, the power cord and the power plug for damage every time before use. • Only use the compressor if all components are intact. CAUTION Quality of treatment impaired by electromagnetic interference The use of third-party products can result in higher levels of electromagnetic emissions or lower the resistance of the PARI device to electromagnetic interference. • Use only original spare parts and original accessories from PARI. • Assemble the nebuliser as described in the instructions for use of the nebuliser. • Insert the connection tube of the PARI nebuliser with a slight twist into the air outlet on the compressor.

• Insert the nebuliser in the holder on the compressor intended for this purpose. • Fill the nebuliser as described in the instructions for use of the nebuliser.

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WARNING Danger of electrocution due to damp hands Liquids can conduct electricity, thereby posing a risk of electric shock. • Never take hold of the power cord or the power plug with damp or wet hands. • Connect the power cord to the power cord socket of the compressor. • Plug the power plug into a suitable socket.

3.3 Performing treatment WARNING Danger of death by mixing up tubes When several tubing systems are present, there is a possible danger of death if different connection options are confused with each other. This danger applies particularly in the case of patients in need of constant care who must receive artificial nutrition or other infusion treatments, for example. • Check carefully to ensure that the other end of the PARI connection tube that is connected to the compressor is attached to the PARI nebuliser.

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CAUTION Quality of treatment impaired by electromagnetic interference If electrical devices are placed too close to each other, the function of both can be impaired due to electromagnetic interference. • If the PARI device has to be placed immediately beside or on top of other devices for operation, all devices must be monitored to ensure that they are working properly. NOTICE Danger of device fault due to overheating Air must be able to circulate freely around the compressor to dissipate the heat generated in the housing. • Never operate the compressor while it is in a bag. • Never cover the compressor while it is operating. • Make sure that the ventilation slits on the compressor are unobstructed at all times while it is operating. • Before starting the treatment, pull the nebuliser out of the holder.

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• Switch the compressor on. WARNING! Danger of death by electrocution from a faulty device! If the device has a fault, a person may come into contact with live parts, resulting in the danger of electric shock, for example. Switch the compressor off and disconnect the power plug from the mains socket immediately if a fault is suspected (e.g., following a fall or if there is a smell of burning plastic). • Check that an aerosol is being generated before you start with the inhalation. • Perform the inhalation as described in the instructions for use of the nebuliser.

3.4 Ending the treatment • Switch the compressor off. • Place the nebuliser back in its holder. • Disconnect the power plug from the mains socket. Complete disconnection from the mains is only certain when the power plug has been unplugged from the socket.

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MAINTENANCE

Do not attempt to carry out any maintenance on the device unless it is switched off and the power plug has been disconnected from the socket.

4.1 Cleaning WARNING Danger of electrocution Liquids can conduct electricity, thereby posing a risk of electric shock. • Always switch the compressor off and disconnect the power plug from the mains socket before starting to clean it. NOTICE Danger of device fault due to liquid penetration If liquids get into the interior of the device, this may cause a fault in the device. • Never spray any liquids onto the compressor or the power cord. • Wipe the outer surface of the housing with a clean, damp cloth.

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In order to clean the nebuliser, the connection tubing and the accessories, follow the notes in the respective instructions for use. If liquid does get into the compressor, the device must not be used under any circumstances. Before using the compressor again, you must contact the PARI GmbH Technical Service department or Service Center.

4.2 Replacing the filter NOTICE Danger of device fault due to incorrect air filter If air filters that are not designed for the compressor are used, the compressor may be damaged. • Only use air filters provided by PARI for use with your compressor. In normal operating conditions, the compressor filter must be replaced after every 200 operating hours, but at least once a year. Also please check the filter at regular intervals (after every 10 applications). If it is soiled (grey or brown colour) or blocked, replace it. The filter must also be replaced with a new one if it has become damp. The filter cannot be cleaned and then reused! To replace the filter, proceed as follows: • Unscrew the filter holder from your compressor using a suitable coin. • Pull the old filter out of the filter holder and fit the new filter in its place.

• Reinsert the filter holder together with the new filter in your compressor and screw it tight with the coin.

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4.3 Repairing The compressor must only be serviced by the PARI GmbH Technical Service department or a service centre expressly authorised by PARI. If the compressor is opened or manipulated by anyone else, all claims under the warranty shall be void. In these cases, PARI GmbH will also accept no liability.

4.4 Storage NOTICE Damage to the power cord by kinking If the power cord is wound or bent very tightly, the wires inside the cable may break. This will render the power cord unusable. • Do not wind the power cord around the compressor. • Disconnect the power cord from the compressor and wind it up. • Clip the power cord below the carrying handle for storage.

Store the compressor and accessories safely out of continuous direct sunlight. Always disconnect the compressor from the mains for storage because electrical devices that remain plugged in present a potential hazard source.

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5

TROUBLESHOOTING

In the event of faults that are not listed in this chapter, or if the suggested procedure does not correct the fault, contact the PARI GmbH Service Center. Fault

Possible cause

The compressor does not start up.

The power cord is not Check that the power plugged into the device cord is seated correctly properly. in the compressor power cord socket.

No medication is coming out of the nebuliser.

Procedure

The power plug is not plugged into the mains socket properly.

Check that the power plug is seated correctly in the mains socket.

The nebuliser nozzle is blocked.

Clean the nebuliser.

The connection tube is Check that both ends of not connected properly. the tube are seated properly. The connection tube is leaking.

Replace the connection tube.