LC SPRINT Familie Instructions for Use April 2012

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INSTRUCTIONS FOR USE For use at home

Table of contents 1 IMPORTANT INFORMATION...26 2 PRODUCT DESCRIPTION ...29 2.1 Components ...29 2.2 Material information...31 2.3 Intended use...31 3 INHALATION ...33 3.1 Assembling the nebuliser ...33 3.2 Filling with medication ...35 3.3 Performing the inhalation ...36 4 CLEANING AND DISINFECTION ...38 4.1 Preparation...38 4.2 Care of the connection tubing ...38 4.3 Cleaning ...38 4.4 Disinfection...39 4.5 Drying and storage ...40 5 MISCELLANEOUS ...41 5.1 Disposal...41 5.2 Contact ...41 5.3 Technical data ...41 6 REPLACEMENT SETS, SPARE PARTS AND ACCESSORIES ...42

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1 IMPORTANT INFORMATION Please read these instructions for use through in their entirety. 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. These instructions for use are destined for the user at home. Separate instructions for use are available for technical personnel on the Internet under "Products" at www.pari.de/en/Products (on the relevant product page under "Products") or as a hard copy on request from PARI GmbH. Safety-relevant warnings are categorised into hazard levels in these instructions for use: - The signal word WARNING is used to indicate hazards which, without precautionary measures, might result in serious injury or even death. - The signal word CAUTION is used to indicate hazards which, without precautionary measures, might result in minor to moderate injury or impair treatment. - The signal word NOTE is used to indicate general precautionary measures which should be observed when using the device to avoid damaging it.

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WARNING When treating babies, children and anyone who requires assistance the following must be observed without fail: - 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 tubing), thus resulting in a risk of injury. - The product contains small parts. Small parts can block the respiratory tract and pose a choking hazard. Therefore, make sure that you always keep these parts out of the reach of babies and infants. - The PARI baby mask is used to treat babies and infants who are not yet able to inhale through a mouthpiece. The baby mask should only be used in conjunction with the baby bend. The baby or infant is able to exhale freely through the slots in the baby bend, so avoiding the risk of shortness of breath. - The nebulisers are only designed for patients who are able to breathe by themselves and are conscious. This is the only way to ensure effective treatment and avoid a choking hazard. Patients with a surgical opening in the windpipe (tracheostoma): Patients who have undergone a tracheostomy are unable to breathe in with the mouthpiece and thus require the PARI TRACHEO SET with a special tracheal mask to inhale. When using the tracheal mask, make sure that the nebuliser cap is open during inhalation. This allows the user to exhale freely and avoids the risk of shortness of breath.

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CAUTION Replace all nebuliser components after a year at the latest as changes may occur in the material of the nebuliser over time. This might impair the effectiveness of the treatment. This is why we introduced the PARI Year Packs (see chapter 6). For inhalation treatment only use a nebuliser and accessories which have been cleaned, disinfected and dried according to chapter 4. Contamination and residual moisture encourage the growth of bacteria, so increasing the risk of infection. Please therefore observe the following instructions on hygiene: • Before every use and cleaning wash your hands carefully. • Clean, disinfect and dry your nebuliser and accessories according to chapter 4. Make absolutely sure you also carry out cleaning, disinfection and drying before using the device for the first time. • For cleaning and disinfection always use fresh tap water of drinking water quality. • Make sure all components are dried properly whenever you have performed cleaning or disinfection. • Do not keep the nebuliser or accessories in a damp environment or together with damp objects. CAUTION If symptoms persist or if your condition worsens, discontinue the inhalation treatment and contact your doctor immediately.

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2 PRODUCT DESCRIPTION 2.1 Components Use the following tables to check whether all components belonging to your nebuliser set are included (figure on front cover page). Should anything be missing, notify the dealer from whom you obtained your nebuliser at once.

LC SPRINT

LC SPRINT Junior

Packages

BOY SX

Basic equipment with compressor

Nebuliser upper section (1a)

×

×

×

Nozzle attachment (1b)

×

×

blue yellow red

× ×

Nebuliser lower section (1c)

×

×

×

Connection tubing (2)

×

×

×

Mouthpiece (3)

×

×

×

Child mask soft (4)

×

×

Rubber band (5)

×

×

Baby mask (6a) with baby bend (6b) LC interrupter (7)

× ×

a)

PIF Control System

a) PIF Control System: Peak Inspiratory Flow

×

×

×

×

×

×

×

×

LC SPRINT STAR nebuliser

×

×

LC SPRINT BABY nebuliser

×

× ×

LC SPRINT Junior Package

×

× ×

red

×

×

×

×

×

×

×

×

Nebuliser lower section (1c)

×

Connection tubing (2) Mouthpiece (3)

×

×

×

×

×

×

×

×

×

×

×

×

×

×

Baby mask (6a) with baby bend (6b) Filter insert (8) for 047, 053, 085 type PARI compressors

LC SPRINT Junior nebuliser

yellow

LC SPRINT nebuliser

×

blue

BOY SX Year Pack

Nebuliser upper section (1a) Nozzle attachment (1b)

TurboBOY Year Pack S

Subsequent purchase sets

LC SPRINT JuniorBOY Year Pack S

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× ×

PIF Control Systema) a) PIF Control System: Peak Inspiratory Flow

×

× ×

×

× ×

×

×

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2.2 Material information Polypropylene Silicone Thermoplastic elastomer Polyester Synthetic rubber (latex-free)

Nebuliser, Mouthpiece, Child mask soft, Adult mask soft, Baby bend, LC interrupter Baby mask Mouthpiece, Child mask soft, Adult mask soft, Nebuliser Rubber band

2.3 Intended use Used with a PARI compressor, the nebulisers of the PARI LC SPRINT family are designed for inhalation treatment of the lower and upper respiratory tract. Each nebuliser should only be used at home by a single patient for hygiene reasons. With regular usage all parts of the nebuliser can be used for up to one year. Each application generally takes between 5 and 10 minutes, however not more than 20 minutes (depending on the dosage of medication and the compressor used). Only approved medication should be used for inhalation treatment. This is generally determined by the doctor in charge. Make sure you take note of any restrictions given in the instructions for use of the relevant medication. The frequency of application depends on the clinical picture and the medication used. The nebulisers are only designed for patients who are able to breathe by themselves and are conscious. Only original PARI compressors and PARI accessories should be used. PARI GmbH cannot be held liable for damage caused by using PARI nebulisers with compressors or accessories from other manufacturers. Please read and follow the instructions for use with your compressor and/or accessory.

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The PARI LC SPRINT nebuliser is available in a range of models catering for different age groups and requirements. - PARI LC SPRINT (nozzle attachment: blue) Including mouthpiece for universal treatment of the respiratory tract in children from approx. 4 years and adults. - PARI LC SPRINT Junior (nozzle attachment: yellow) Specially designed to treat the respiratory tract in infants and children. Used in combination with a baby mask to treat babies and infants up to approx. 4 years who are not yet able to inhale through a mouthpiece. - PARI LC SPRINT STAR (nozzle attachment: red) Including mouthpiece, specially designed to treat the deep respiratory tract in children up to approx. 4 years and adults, additionally equipped with inspiratory flow control (PIF Control System1). - PARI LC SPRINT BABY (nozzle attachment: red) Specially designed for use with the baby mask to treat the respiratory tract in babies (including premature babies) and infants up to approx. 4 years.

1) For further information about the PIF Control System see page 37.

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3 INHALATION Inhalation with the mouthpiece is the most effective way of treating the lower respiratory tract as this allows the greatest possible quantity of medication to reach the lung. If it is not possible to use a mouthpiece, or if the patient prefers to inhale through a mask, PARI can provide the right accessories. 3.1 Assembling the nebuliser CAUTION Check all nebuliser components and the accessories before each use. Replace any broken, misshapen or seriously discoloured parts. Please also follow the instructions for assembly given below. Damaged components and/or an incorrectly assembled nebuliser may impair functioning of the nebuliser and thus treatment as well. • Gently push the nozzle attachment (1b) as far as it will go onto the nozzle in the nebuliser lower section (1c) of the nebuliser. The arrow on the nozzle attachment must point upwards. • Place the nebuliser upper section (1a) on the nebuliser lower section and turn it clockwise to lock the two parts together. • Fit the connection tubing (2) onto the nebuliser. • Connect the connection tubing to the compressor.

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Using with baby bend and baby mask • Place the baby mask (6a) on the baby bend (6b). Use your thumb to press the baby mask from the inside over the first lip of the baby bend. • Attach the baby bend to the nebuliser upper section. Using with a mouthpiece • Attach the mouthpiece (3) to the nebuliser upper section.

Using with a child or adult mask • Attach the child or adult mask to the nebuliser upper section. When using a mask, make sure that the expiratory valve plate is pressed out so you can exhale freely during inhalation.

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3.2 Filling with medication NOTE Take care to ensure that the cap only moves in the direction allowed by the hinge. Otherwise the nebuliser cap might snap off. • Release the closure on the nebuliser upper section (1a) by pressing your thumb against the underside of the cap. • Pour the quantity of medication prescribed by your doctor into the nebuliser funnel. • Ensure that the medication is filled no higher than the upper scale marking (max. level 8 ml). Overfilling may greatly impair the nebulisation of medication. • If you plan to inhale several medications one after the after in one application, rinse out the nebuliser with tap water between inhalations. Remove excess water by shaking the nebuliser and then fill with medication as described. • Close the cap of the nebuliser. Make sure that the cap snaps into place.

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3.3 Performing the inhalation Before the patient starts inhaling, ensure that all parts are firmly connected to each other. Perform inhalation until the medication is used up (signalled by a change in the sound of the nebuliser). Several drops of medication will remain in the nebuliser after inhalation. Inhalation with baby bend and baby mask • Swivel the bend so that it corresponds with the position of the baby or infant. Always hold the nebuliser upright. • Switch the compressor on. • Press the mask gently but firmly over the mouth and nose. When they are unwell, infants often struggle against having the mask pressed against their faces, and turn their heads from side to side. To ensure effective inhalation, hold the mask firmly in your hand and rest your little finger against your child's cheek. This will enable you to follow the movements of his or her head with the mask more easily. • Perform treatment. For best inhalation, your child/baby should breathe in and out as slowly and deeply as possible. • Switch the compressor off as soon as you have finished inhalation.

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Inhalation with mouthpiece, child or adult mask • Sit in an upright position and relax. • Switch the compressor on. • Take the mouthpiece between your teeth and close your lips around it or press the mask lightly over the mouth and nose. • Breathe in through the mouthpiece or mask as slowly and deeply as possible and then out again in your own time. • Switch the compressor off as soon as you have finished inhalation. Information about using a nebuliser with the PIF Control System: The PARI PIF Control System in the upper section of the nebuliser reduces the air supply, so creating increased resistance when inhaling. The objective here is to help you learn slow, controlled inhalation. If you notice increased resistance during treatment when inhaling, try to breathe in slowly so that such increased resistance is no longer felt. This will improve the uptake of medication in the lower respiratory tract.

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4 CLEANING AND DISINFECTION Clean the nebuliser and the accessories used after every application. Disinfect the nebuliser at least once a day. 4.1 Preparation • Disconnect the tubing from the nebuliser. • For this purpose dismantle the nebuliser into its individual parts. • Carefully pull the expiratory valve out of the slot in the mouthpiece. The valve should still be attached to the mouthpiece. 4.2 Care of the connection tubing • Connect the connection tubing to the compressor. • Switch the compressor on. • Leave the compressor running until any condensation in the tubing has been removed by the air flowing into the tube. 4.3 Cleaning • Thoroughly clean all components (except for the connection tubing) in warm tap water and dishwashing liquid for about 5 minutes. If necessary, use a clean brush to remove loose dirt (the brush should be solely reserved for this purpose). • Then rinse all parts thoroughly under warm running water. • You can remove excess water more quickly by shaking all parts. Remember to hold the cap of the nebuliser upper section, otherwise the hinge may be damaged by shaking.

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4.4 Disinfection After cleaning, disinfect the dismantled nebuliser and accessories used (except for the connection tubing). Effective disinfection is only possible if the nebuliser has been cleaned. Information when using masks with rubber bands: The rubber band can only be cleaned as it might be damaged by the high temperatures used during disinfection. In boiling water • Place the individual parts of your nebuliser in boiling water for at least 5 minutes. Use a clean pan and fresh drinking water. If your water is very hard, scale may be deposited on the nebuliser parts as a milky coating. This can only be prevented by using softened water. NOTE Plastic will melt if it comes into contact with the hot base of the pan. You should therefore make sure there is plenty of water in the pan. This way you will avoid damaging the nebuliser parts. Using a standard thermal disinfector for baby bottles (not a microwave oven) Disinfection must last at least 15 minutes. Regarding disinfection and the quantity of water necessary, make sure you observe the instructions for use of the relevant disinfector. Always check carefully that it is clean and fully functional.

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CAUTION A damp environment may encourage the growth of bacteria. You should therefore remove the nebuliser and accessories from the pan or disinfector as soon as disinfection has finished. Dry parts according to chapter 4.5. Drying completely reduces the risk of infection. 4.5 Drying and storage • You can remove excess water more quickly by shaking all parts. Remember to hold the cap of the nebuliser upper section, otherwise the hinge may be damaged by shaking. • Place the nebuliser parts on a dry, clean and absorbent surface and let them dry completely. • When drying, between applications, and in particular during long breaks, wrap the nebuliser in a clean, lint-free cloth (e.g. a tea-towel) and keep in a dry, dust-free environment. • During storage, make sure the nebuliser and accessories are protected from continuous exposure to direct sunlight.

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5 MISCELLANEOUS 5.1 Disposal All nebuliser components and the accessories can be disposed of with domestic waste unless this is prohibited by the disposal regulations prevailing in the respective member countries. 5.2 Contact For all product information and in the event of defects or questions about usage please contact our Service Center: Tel.: +49 (0)8151-279 279 (German-speaking) +49 (0)8151-279 220 (international) 5.3 Technical data Operating gases:

Air, oxygen

Minimum flow:

3.0 l/min.

Corresponding minimum operating pressure:

0.5 bar/50 kPa

Maximum flow:

6.0 l/min.

Corresponding maximum operating pressure:

2.0 bar/200 kPa

Minimum fill volume:

2.0 ml

Maximum fill volume:

8.0 ml

Aerosol data according to DIN EN 13544-1 is available on request from PARI GmbH or on the Internet under "Products" at www.pari.de/en/Products (on the relevant product page under "Technical data").

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6 REPLACEMENT SETS, SPARE PARTS AND ACCESSORIES The figures relating to the components can found on the front cover page. Pos. Description no.

Item no.

Replacement sets: PARI JuniorBOY Year Pack S

023G1110

PARI TurboBOY Year Pack S

023G1010

PARI BOY SX Year Pack incl. 2 nozzle attachments

023G8510

Spare parts and accessories: 1

2

3

PARI LC SPRINT

023G1000

PARI LC SPRINT Junior

023G1100

PARI LC SPRINT STAR

023G1250

PARI LC SPRINT Junior Package (with BABY mask size 2)

023G1120

PARI LC SPRINT BABY size 0 (for premature babies)

023G1400

PARI LC SPRINT BABY size 1 (for age up to 1 year)

023G1401

PARI LC SPRINT BABY size 2 (for age 1-3 years)

023G1402

PARI LC SPRINT BABY size 3 (for age approx. 3 years and older)

023G1403

Connection tubing for PARI compressors (1.2 m)

041B4591

Connection tubing for PARI compressors (2.1 m)

041B4599

Mouthpiece

022E3050

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Pos. Description no. 4

Item no.

Adult mask soft

041G0740

Child mask soft "Spiggy" (without BABY bend)

041G0741

BABY mask size 0 with BABY bend (for premature babies)

041G0700

BABY mask size 1 with BABY bend (for age up to 1 year)

041G0701

BABY mask size 2 with BABY bend (for age 1-3 years)

041G0702

BABY mask size 3 with BABY bend (for age approx. 3 years and older)

041G0703

6b

BABY bend

041E0701

6

7

LC interrupter

022G1000

9

PARI Filter/Valve Set

041G0500

10

PARI PEP S System

018G4000

11

PARI SMARTMASK (incl. 45 degree elbow piece)

041G0730

12

PARI SMARTMASK Kids (incl. 45 degree elbow piece)

078G5000

13

PARI TRACHEO SET

025G0007

14

Sputum trap

041G0530

15

Nose clip

041E3500

16

Filter screw with filter (only for type 085 compressors)

085B1130

17

Filter holder with filter for 038, 047, 053 type PARI compressors

041G4800