LC SPRINT Familie Instructions for Use Feb 2015

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Instructions for use Information as of: 2014­12. All rights reserved. Technical and design changes and printing errors reserved. Principle shown in figures.

IMPORTANT INFORMATION... General... Information about the instructions for use ... Structure of safety instructions ... Treatment of babies, children and anyone who requires assistance ... Treatment of patients with a surgically created opening in the windpipe (tracheostoma) ... Hygiene ...

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PRODUCT DESCRIPTION ... Components ... Intended use... Proper use ... Contraindications... Product variants and combinations ... Material information ... Operating life ...

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INHALATION ... Assembling the nebuliser ... Filling with medication ... Performing the inhalation ...

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CLEANING AND DISINFECTION AT HOME ... Preparation ... Care of the connection tubing ... Cleaning ... Disinfection ... Visual inspection ... Drying and storage ...

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MISCELLANEOUS ... Disposal... Technical data ... 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. If symptoms persist or if your condition worsens, discon­ tinue the application and contact your doctor immediately.

1.2 Information about the instructions for use These instructions for use are intended for the user at home. A separate copy of instructions for use is available for medical specialists. If these instructions for use are lost, you can request another copy from PARI GmbH [see also: Contact, page 54]. The in­ structions for use for some products can be retrieved on the in­ ternet in both German and English. Simply visit: www.pari.de/ de­en/products (on the respective product page).

1.3 Structure of safety instructions Safety­critical warnings are categorised according to hazard levels in these instructions for use: – 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 precau­ tionary measures which are to be observed to avoid dam­ aging the product during use.

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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. In­ dividuals in this group often underestimate the hazards in­ volved (e.g. strangulation with the power cord or the connec­ tion 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. Special masks may be obtained for treating babies and infants who are not yet able to inhale using the mouthpiece. 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.

1.5 Treatment of patients with a surgically created opening in the windpipe ﴾tracheostoma﴿ Tracheostomised patients cannot use the mouthpiece to inhale and therefore need the PARI TRACHEO SET with a special tracheostoma mask for an inhalation session. If a tracheo­ stoma mask is used, make sure that the nebuliser cap is open during inhalation. This ensures unobstructed expiration and avoids the risk of shortness of breath.

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1.6 Hygiene Observe the following hygiene instructions: – Do not use product components for inhalation therapy un­ less they have been thoroughly cleaned and dried. Contam­ ination and residual moisture encourage the growth of bac­ teria, so increasing the risk of infection. – Before every use and cleaning, wash your hands thoroughly. – Make absolutely sure you also carry out cleaning and drying before using the device for the first time. – For cleaning and disinfection, always use fresh water with reduced calcium content. – Make sure all components are dried properly whenever you have performed cleaning or disinfection. – Do not keep the product and accessories in a damp environ­ ment or together with damp objects.

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2

PRODUCT DESCRIPTION

2.1 Components The components included vary depending on the pack. To find out which components are included in your pack, refer to the following table. Check that all components of your PARI product are contained in your pack. If anything is missing, please notify the dealer from whom you purchased the PARI product immediately.

Components Your pack may contain the following components:

(1)

Nebuliser upper section

(2)

Nozzle attachment

(3)

Nebuliser lower section

(4)

Mouthpiece

(5)

LC interrupter

(6)

Baby mask with baby bend

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(7)

a) Child mask soft b) Adult mask soft

(8)

a) Connection tubing (f/m) b) Connection tubing (f/f)

(9)

Tubing adapter

(10) LC Tracheal adapter (11) Filter insert for compressor

Packs The following components are included in all nebuliser packs: (1) Nebuliser upper section (2) Nozzle attachment (3) Nebuliser lower section The following components may also be included with the product depending on the pack: Pack no. (REF) 023B80012)

PIF1) (4) (5) (6) (7a) (7b) (8a) (8b) (9) (10) (11) ×

×

023B80062)

×

×

×

×

×

023B8051

×

023B8054

×

023B8055

×

023B8101

×

023G1001

×

×

023G1011

×

×

023G1101

×

×

023G1111

×

×

×

×

×

×

×

×

× × ×

× ×

× ×

023G1080

023G1250

× ×

×

×

× ×

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Pack no. (REF)

PIF1) (4) (5) (6) (7a) (7b) (8a) (8b) (9) (10) (11)

023G1400

×

×

023G1401

×

×

023G1402

×

×

023G1403

×

×

023G6001 023G6002

× ×

×

023G6003

×

023G85112)

×

×

×

1) PIF­Control­System: (PIF = Peak Inspiratory Flow) 2) incl. second nozzle attachment

2.2 Intended use The nebulisers of the PARI LC SPRINT family are medication nebulisers that are designed to be used in conjunction with a PARI compressor for inhalation therapy of the lower and/or up­ per respiratory tract. Each application generally takes between 5 and 10 minutes (depending on the quantity of medication), but in no case more than 20 minutes. Only original PARI compressors and PARI accessories must 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 of the com­ pressor and of the accessories you are using.

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2.3 Proper use The nebuliser is intended exclusively for home use. For reasons of hygiene, the nebuliser, the mouthpiece and the masks must only be used by a single patient. This product is only designed for patients who are able to breathe by themselves and are conscious. Only medication that has been approved for inhalation treat­ ment must be used. Take note of any restrictions in the instruc­ tions for use of the medication in question.

2.4 Contraindications None.

2.5 Product variants and combinations The PARI LC SPRINT nebuliser can be operated with all PARI compressors that are available on the market. The PARI LC SPRINT nebuliser is available in various versions for different age groups and requirements: – PARI LC SPRINT (nozzle attachment: blue) With mouthpiece for general treatment of the respiratory tract in adults and children aged approx. 4 years and older. – PARI LC SPRINT Junior (nozzle attachment: yellow) For treating the respiratory tract in infants and children. In conjunction with a baby mask for treating babies and infants up to about 4 years old who are not yet able to inhale using the mouthpiece. – PARI LC SPRINT STAR (nozzle attachment: red) With mouthpiece for treatment of the deep respiratory tract in adults and children aged approx. 4 years and older.

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– PARI LC SPRINT BABY (nozzle attachment: red) With baby mask and baby bend for treatment of the respirat­ ory tract in babies (including premature babies) and infants aged up to about 4 years old.

2.6 Material information Polypropylene

Nebuliser, mouthpiece, child mask soft, adult mask soft, baby bend, LC interrupter, LC tracheal adapter

Silicone

Baby mask

Thermoplastic elastomer

Mouthpiece, child mask soft, adult mask soft, nebuliser

Polyester

Rubber band

Synthetic rubber

Rubber band

2.7 Operating life Replace the nebuliser after a year at the latest as changes can occur in the material of the nebuliser over time. This might im­ pair the effectiveness of the treatment.

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3

INHALATION

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 as­ sembly given below. Damaged components and/or an incorrectly assembled nebuliser may impair functioning of the nebuliser and thus treatment as well. • Press the nozzle attachment lightly onto the nozzle in the nebuliser lower section. The arrow on the nozzle at­ tachment must point upwards. • Place the nebuliser upper sec­ tion on the nebuliser lower sec­ tion and turn it clockwise to lock the two parts together.

• Attach the connection tubing to the nebuliser.

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Using with a mouthpiece • Fit the mouthpiece onto the nebuliser.

Use with a baby mask and baby bend • Attach the baby mask to the baby bend. Use your thumb to press the baby mask from the inside over the first ridge on the baby bend. • Attach the baby bend to the nebuliser.

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Using with a child or adult mask • Attach the child or adult mask to the nebuliser.

When using a mask, make sure that the expiratory valve plate is pressed out so you can exhale freely during an inhalation session.

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3.2 Filling with medication NOTICE Take care to ensure that the cap only moves in the direction allowed by the hinge. Otherwise the nebuliser cap might snap off. • Insert the nebuliser in the holder on the compressor intended for this purpose. • Open the nebuliser cap by pressing your thumb against the underside of the cap. • Pour the quantity of medication prescribed by your doctor into the nebuliser nozzle attach­ ment. Be sure to follow the instruc­ tions regarding the minimum and maximum fill volumes [see also: Technical data, page 53]. If the nebuliser con­ tains too little or too much medication, nebulisation, and thus also the treatment, will be greatly impaired. • Close the nebuliser cap. Make sure that the cap snaps into place. If you are to inhale several medications one after the other 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.

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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 (indicated by a change in the sound of the nebuliser). Several drops of medication will remain in the nebuliser after inhalation.

Information on using a nebuliser with PIF­Control­ System: The PARI PIF­Control­System in the nebuliser upper section re­ stricts the inflow of air and so cre­ ates increased inspiratory resist­ ance. It is used to help patients to learn slow, controlled inhalation. If you notice increased resistance when breathing in during a treat­ ment session, try to inhale more slowly, until you no longer feel the increased resistance. In this way, you will improve the amount of medication that is delivered to the lower respiratory tract. • Connect the connection tubing to the compressor and switch the compressor on.

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Inhalation with mouthpiece or with child or adult mask • Sit in an upright position and relax. • Take the nebuliser out of its holder and hold it upright. • 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 breathe out in a relaxed man­ ner. • Replace the nebuliser in the holder as soon as you have fin­ ished inhaling. • Switch the compressor off.

Inhalation with a baby mask and baby bend The baby mask must only be used in conjunction with the baby bend. The baby or infant can breathe out without obstruction and the risk of shortness of breath is avoided.

• Adjust the alignment of the bend and the mask according to the position the baby or in­ fant is in. • Gently press the mask against the face so that it fits snugly over the mouth and nose. Make sure that the nebuliser is upright.

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Sick infants often struggle when the mask is pressed against their face, and twist their head back and forth. To ensure effective inhalation, hold the mask firmly in your hand and rest your little finger against the child's cheek. This will enable you to follow the movements of the child's head with the mask more easily.

• Complete the treatment session. • Replace the nebuliser in the holder as soon as you have fin­ ished inhaling. • Switch the compressor off.

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4

CLEANING AND DISINFECTION AT HOME

The nebuliser and the accessories used must be cleaned thoroughly after each application and disinfected at least once a day. The connection tubing cannot be cleaned or disinfected.

4.1 Preparation • Detach the tubing from the nebuliser. • Make sure that all medication residues are removed from the nebuliser. • Dismantle the nebuliser into its individual parts. • Carefully pull the blue expirat­ ory valve out of the slot in the mouthpiece. The valve must still be attached to the mouth­ piece. • Rinse all components of the nebuliser under running tap wa­ ter. This must be done especially thoroughly if cleaning and disinfection are not carried out straight away.

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.