Easy Care Instructions for Use Rev A Oct 2012

Instructions for Use: EASYCARE Cleaning Aid for eRapid™ Aerosol Heads

3.3.

Read these instructions carefully and completely before using EASYCARE for the first time. Keep these instructions in a safe place.

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Product description The EASYCARE cleaning aid (EASYCARE) consists of two hinged plastic parts. The dark gray part provides a mounting for the eRapid Aerosol Head, while the other, light gray part has a built-in funnel opening and receptacle for filling 5 ml isotonic sodium chloride solution (0.9%). The eBase™ Controller and Nebulizer Connection Cord are required for EASYCARE’s operation. Information on connecting the Controller to the AC Power Supply and on operating the Controller can be found in Sections E and F of the eRapid Instructions for Use. Intended use The EASYCARE is intended to be used only with the eRapid Aerosol Head. DO NOT USE EASYCARE WITH ANY OTHER EFLOW® TECHNOLOGY PRODUCTS.

The EASYCARE should help to shorten the nebulization time if the eRapid Aerosol Head is has become clogged. EASYCARE allows the pores in the membrane of the eRapid Aerosol Head to be mechanically rinsed free by means of backwashing in the opposite direction. 3.

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Backwashing Procedure 4.1. Open the EASYCARE.  Press lightly on the side gripping surfaces to release the side engaging hooks.  Gently pull the light gray funnel part outward and down.

4.2.

Important information for use Cleaning with the EASYCARE is recommended if the nebulization time for the same fill volume of a given substance significantly increases. The FUNCTIONALITY TEST contained in Section K, in the corresponding eRapid Instructions for Use can help determine this. Example:  Measure the nebulization time with 2.5 ml isotonic sodium chloride solution (0.9%) without inhaling.  If the nebulization time for 2.5 ml takes longer than 4 minutes, cleaning with the EASYCARE cleaning aid is recommended. NOTE: you will have approximately 1 ml (1/5 teaspoon) of solution left in the reservoir following the test. This is normal. 3.1.

Frequency of use As needed, no more than two times weekly after inhalation and after cleaning the Aerosol Head (see cleaning steps below). More frequent use than twice weekly can lead to premature material wear. During its entire period of use, an Aerosol Head should not be backwashed more than 25 times with the EASYCARE cleaning aid. The EASYCARE cleaning aid does not extend the life cycle of the Aerosol Head.

3.2.

Backwash liquid 5 ml isotonic sodium chloride solution (Normal saline, 0.9%)

Cleaning steps The EASYCARE procedure is performed as an additional measure for the normal cleaning of the aerosol head. Please ensure that the following cleaning steps are observed during EASYCARE backwashing:  Clean the eRapid Nebulizer parts and Aerosol Head. See Section H of the eRapid Instructions for Use.  Backwash the Aerosol Head with EASYCARE. In addition to these EASYCARE Instructions For Use, refer to Section I of the eRapid Instructions for Use.  Disinfect the eRapid Nebulizer parts including Aerosol Head. See Section J of the eRapid Instructions for Use.

Insert the Aerosol Head so the “eRapid” label is UPSIDE DOWN and close the EASYCARE reservoir.  Insert the Aerosol eRapid Label Head into the dark gray reservoir part as shown at right. The Aerosol Head will be felt to snap into place when it has properly inserted. • When closing, ensure that the two side engaging hooks are felt to snap into place.

4.3.

Connect the EASYCARE cleaning aid to the eBase Controller that came with your eRapid Nebulizer System.  Attach the horseshoe-shaped end of the Connection Cord UPSIDE DOWN to the hinge of the EASYCARE reservoir part and swivel it downwards. Ensure that the Connection Cord’s metal  Connect the other end of contacts engage the cable to the front of with the Aerosol the eBase Controller. Head’s metal inserts.