BOY SX, JuniorBOY SX and TurboBOT SX Instructions for Use April 2012

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Instructions for use Information as of: 2011-11. We reserve the right to make technical changes.

IMPORTANT INFORMATION ...29 General ...29 Structure of safety instructions...29 Using the compressor ...29 Treatment of babies, children and anyone who requires assistance ...31 PRODUCT DESCRIPTION...32 Components...32 Intended use ...32 Working parts ...33 Product variants and combinations ...34 Operating life...34 PREPARATION FOR USE ...35 Setup...35 Preparation...36 Performing the inhalation ...37 Completing the inhalation...38 MAINTENANCE...39 Cleaning the compressor ...39 Filter change ...40 Servicing ...41 Storage...41 TROUBLESHOOTING...42 TECHNICAL DATA ...43 General ...43 Classification according to DIN EN 60601-1 ...43 Information about electromagnetic compatibility ...44 Recommended safety distances ...44 Ambient conditions for operation...45

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MISCELLANEOUS... 46 Transportation and storage... 46 Disposal ... 46 Terms and conditions of warranty... 46 Contact ... 48 Explanation of symbols... 48 SPARE PARTS ... 49

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1 IMPORTANT INFORMATION 1.1 General Please read these instructions for use and the instructions for use of the accessories supplied 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. Please read these instructions for use ...

1.2 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 NOTE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

1.3 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.

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– Only use the PARI power cord to operate the compressor. – 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. – 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.

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1.4 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 tubing), thus resulting in a risk of injury. The product contains small parts. Small parts can block the respiratory tract 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 compressor is an electrically powered device. Babies, infants, children, and anyone who requires assistance must be supervised constantly by an adult during inhalation therapy. Otherwise, safe and effective treatment cannot be guaranteed. The device and the connection tubing at the compressor outlet can become very warm during normal operation. Therefore, particularly when dealing with individuals who require special assistance, ensure that their 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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2 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. Check that all...

(1) Compressor (2) Power cord

2.2 Intended use The purpose of the compressor is to generate compressed air for operating a PARI nebuliser. The compressor must only be used for PARI nebulisers. It is intended exclusively for indoor use. Any use for other purposes or use of nebulisers or accessories from other manufacturers may impair the quality of the treatment, cause damage to the device, or even result in injury. PARI GmbH rejects any liability for damage caused by operating the compressor in a manner inconsistent with its intended use. This particularly applies if the compressor is used in any way other than for its intended use or if nebulisers or accessories from other manufacturers are used. In such cases, all claims under the warranty shall also be void.

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2.3 Working parts The compressor includes the following working parts: The compressor includes ...

(3) On/off switch (4) Air outlet (5) Filter holder (6) Holder for nebuliser (7) Power cord socket (rear of the device) (8) Type identification plate (bottom of device) (9) Ventilation slits (10) Carrying handle

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2.4 Product variants and combinations There are three different versions of the PARI BOY SX compressor: – PARI JuniorBOY SX (compressor colour yellow) including the LC SPRINT Junior nebuliser with the yellow nozzle attachment and soft baby mask with babybend – PARI TurboBOY SX (compressor colour blue) including the LC SPRINT nebuliser with the blue nozzle attachment and child mask – PARI BOY SX (compressor colour blue) including the LC SPRINT nebuliser with the blue nozzle attachment, child mask and PEP S system. A red nozzle attachment is also included in the supplied package The compressor is suitable for use with the following nebulisers: – All nebulisers in the PARI LC SPRINT family – All nebulisers in the PARI LC family – PARI LL nebulisers Separate instructions for use accompany all nebulisers, whether they are included in the basic equipment or purchased subsequently.

2.5 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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3 PREPARATION FOR USE 3.1 Setup The room in which the compressor is operated must satisfy certain conditions [See also: 6.5 Ambient conditions for operation]. The compressor is not intended for outdoor use. The room in which ...

When setting up the compressor, ...

CAUTION When setting up the compressor, follow the instructions below to avoid any risk of injury or damage to the device: – Place the compressor on a firm, flat, dust-free, dry surface. A soft base such as a sofa, a bed or tablecloth is not suitable because the compressor might fall. – Route the power cord in such a way that it is not a tripping hazard and no one can become entangled in it. – Make sure that children cannot pull on the power cord or connection tubing and cause the compressor to fall. – Only operate the compressor in a low-dust environment. If it is operated in a very dusty environment (e.g., under the bed or in workshops), or on the floor, a larger amount of dust is likely to collect inside the housing, which may impair the quality of the treatment or damage the compressor. To avoid a ...

WARNING To avoid a risk of fire due to a short circuit, follow the instructions below when setting up the compressor: – Do not operate the compressor close to 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).

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3.2 Preparation Check the compressor housing, the power cord and the power plug for damage every time before using. Make sure that the local supply voltage complies with the voltage data marked on the compressor identification label. Only use the compressor if all components are intact. The compressor must not be operated if the device or the power cord is damaged, or if damage is suspected (e.g., after it has fallen or if there is a smell of burning plastic). Prepare the device for an inhalation session as follows: • Assemble the nebuliser as described in the instructions for use of the nebuliser. • Insert the nebuliser in the holder on the compressor intended for this purpose. • Insert the connection tubing of the PARI nebuliser with a slight twist into the air outlet on the compressor.

Check carefully, ...

WARNING Check carefully whether the other end of the PARI connection tubing connected to the compressor is connected to the PARI nebuliser. When several tubing systems are present, there is a possible danger of death if different connection options are confused with each other. This applies particularly in the case of patients in need of constant care who must receive artificial nutrition or other infusion treatments.

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• Connect the power cord to the power cord socket of the compressor. • Fill the nebuliser as described in the instructions for use of the nebuliser. • Plug the power plug into a suitable socket. Liquids can conduct, ...2

WARNING Liquids can conduct electricity, thereby posing a risk of electric shock. Therefore, never take hold of the power cord or the power plug with damp or wet hands.

3.3 Performing the inhalation To avoid overheating the compressor, never place a cover over the device during operation, and ensure that the side ventilation slits are not obstructed. If the compressor is covered or if the ventilation slits are blocked, the compressor cannot be cooled properly. Perform the inhalation as follows: • Before starting the treatment, pull the nebuliser out of the holder.

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• Start the compressor by pressing the on/off switch. • Check that an aerosol is being generated before you start with the inhalation.

WARNING In the event of damage to the device a person may come into contact with live parts, and there may be a risk of electric shock. Therefore, switch the compressor off and disconnect the power plug from the mains socket immediately if the compressor or the power cord is damaged or if damage is suspected (e.g., following a fall or if there is a smell of burning plastic). • Perform the inhalation as described in the instructions for use of the nebuliser.

3.4 Completing the inhalation • Switch the compressor off. • Place the nebuliser back in its holder. • Disconnect the power plug from the mains socket. Complete disconnection ...2

Complete disconnection from the mains is only certain when the power plug has been unplugged from the socket.

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4 MAINTENANCE 4.1 Cleaning the compressor Liquids can conduct, ...1

WARNING Liquids can conduct electricity, thereby posing a risk of electric shock. Therefore, always switch the compressor off and disconnect the power plug from the mains socket before starting to clean it. • Wipe the outer surface of the housing with a clean, damp cloth.

Liquids that get into the device ...

NOTICE Liquids that get into the device can cause a fault in the device. Therefore, never spray any liquids onto the compressor or the power cord. 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 the PARI Service Center [See also: 7.4 Contact]. 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 ...

In order to clean ...

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4.2 Filter change 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 inhalations). 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! In normal operating conditions, ...

Only use ...

NOTICE Only use air filters that are intended by PARI for use with your compressor, otherwise your compressor might be damaged. 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 Servicing The compressor must only be serviced by the PARI GmbH Technical Service department or a service center 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 • Disconnect the power cord from the compressor. • Wind up the power cord and stow it under the compressor handle.

The power cord can ...

NOTICE The power cord can be damaged if it is kinked. Therefore, do not wind the power cord around the compressor. 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 present a potential hazard source. Always disconnect the compressor ...

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5 TROUBLESHOOTING Table: Faults

Fault

Possible cause

Procedure

The compressor The power cord is not Check that the power does not start up. plugged into the device cord is seated correctly properly. in the compressor power cord socket. The power plug is not Check that the power plugged into the mains plug is seated correctly socket properly. in the mains socket. No medication is The nebuliser nozzle is Clean the nebuliser. coming out of the blocked. nebuliser. The connection tubing Check that both ends is not connected of the tubing are seated properly. properly. The connection tubing Replace the is leaking. connection tubing.

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 [See also: 7.4 Contact]. In the event of faults that ...

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6 TECHNICAL DATA 6.1 General Supply voltage [V] Mains frequency [Hz] Power consumption [A] Housing dimensions [cm] max. compressor flow (FreeFlow) Compressor flow1) Sound pressure level2) Pressure Weight

see back cover page

19.2 × 14.5 × 15 (W × H × D) 10.9 l/min. approx. 5.1 l/min. approx. 56 dBA approx. 1.6 bar 1.7 kg

1) towards PARI nebuliser nozzle (Ø 0.48 mm) 2) Maximum A-evaluated sound pressure level of the compressor (in accordance with DIN EN 13544-1, section 26)

6.2 Classification according to DIN EN 60601-1 Type of electric shock protection

Protection class II Type BF

Degree of protection from electric shock of the part used (nebuliser) Degree of protection against water ingress in No protection accordance with IEC 529 (IP rating) Degree of protection when used in the presence No protection of flammable mixtures of anaesthetics with air, with oxygen, or with nitrous oxide Operating mode Continuous operation

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6.3 Information about electromagnetic compatibility Electrical medical equipment is subject to special precautionary measures with regard to electromagnetic compatibility (EMC). Such equipment must only be installed and operated in accordance with EMC instructions. Portable and mobile high-frequency communication devices can disrupt electrical medical equipment. Using accessories, converters and power cords other than those specified, with the exception of converters and power cords that the manufacturer of the medical electrical device sells as spare parts for internal components, can result in higher emission levels or lower the resistance to interference of the device. The device must not be placed directly beside or on top of other devices for operation. If the medical electrical device must be placed beside or on top of other devices to operate it, it should be monitored constantly to ensure that it is operating properly in the arrangement used. Technical data on electromagnetic compatibility (EMC instructions) in table format are included with the compressor. It can also be ordered from PARI GmbH or downloaded from the internet at www.pari.de/en/products under "Technical Data" on the respective product page.

6.4 Recommended safety distances Recommended safety distances between portable and mobile high-frequency (HF) telecommunication devices and the PARI compressor: The PARI compressor is intended for operation in an electromagnetic environment in which radiated HF transients are monitored. The user can help to prevent electromagnetic interference by observing the minimum safety distances between portable and mobile HF communication equipment

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(transmitters) and the PARI compressor, as recommended below in accordance with the maximum output power of the communication device. Safety distance depending on transmitting frequency: Rated power 150 kHz to 80 of the MHz transmitter [W] D = (3.5/3) × SQRT(P) [m]

80 MHz to 800 800 MHz to MHz 2.5 GHz D = (3.5/3) × D = (7/3) × SQRT(P) [m] SQRT(P) [m]

0.01 0.1 1 10 100

0.2 0.4 1.2 3.8 12

0.2 0.4 1.2 3.8 12

0.3 0.8 2.3 7.3 23

For transmitters whose rated power does not appear in the table above, the safety distance can be calculated using the equation associated with the respective column, where "P" is the rated power of the transmitter in Watt (W) according to the information supplied by the device manufacturer.

6.5 Ambient conditions for operation Ambient temperature Relative humidity Atmospheric pressure

+10 °C to +30 °C 30% to 75% (non-condensing) 700 hPa to 1,060 Pa