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Table of contents
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Table of contents ..............................................................................................................................................16
2
Symbols (ISO 15223-1) .....................................................................................................................................16
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Foreword ..............................................................................................................................................................16
The manual .....................................................................................................................................................................16
Safety requirements .......................................................................................................................................................16
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Specifications ..................................................................................................................................................................17
Functioning .....................................................................................................................................................................17
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Hazards .................................................................................................................................................................18
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The valve..............................................................................................................................................................18
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Assembly of the va lve ......................................................................................................................................20
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Pre-filling insp ections ......................................................................................................................................22
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Filling ....................................................................................................................................................................22
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Checks after filling ............................................................................................................................................22
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Use .........................................................................................................................................................................23
Supply of gas. ..................................................................................................................................................................23
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Periodic inspections .........................................................................................................................................24
Valve traceability. ...........................................................................................................................................................24
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14
Clean lin ess ..........................................................................................................................................................24
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Storage .................................................................................................................................................................25
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Defects - Causes - Remedies .........................................................................................................................25
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Valve repairs . .....................................................................................................................................................25
Procedure for returning valves ........................................................................................................................................25
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Disposal ................................................................................................................................................................26
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Glossary ...............................................................................................................................................................27
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Warranty condition s .........................................................................................................................................27
2
Symbols (ISO 15223-1)
Do not
lubricate
Date of
manufacture
3
Foreword
The manual
This manual provides essential information for safe use of Pergola S.r.l. pressure reducing valves ("valves" below). The valves
comply with the requirements of EN ISO 10524-3 regulations and are produced and CE/π marked in accordance with European
Directives 93/42/EEC and 2007/47/EC (medical devices), 2010/35/EC and ADR (transportable pressure equipment). For use of the
cylinder and related accessories, refer to the warnings for use of the individual products.
The owner of the medical device is responsible for guaranteeing that all valve users are suitably informed of the related methods
of use and of the requirements specified in this manual.
Safety requirements
The valves are homologated for installation on medical gas cylinders and must be used only and exclusively for
the purposes specified in this manual. Pursuant to Directives 93/42/EEC and 2007/47/EC on Medical Devices, the
supplier of the cylinder equipped with valve must ensure that this manual has been furnished to the user. Any
further information concerning the cylinder equipped with valve shall not in any way modify the general meaning
of the warnings furnished in this manual.
To guarantee patient safety, before connecting medical devices and accessories to the valves, verify compatibility
with valve technical and operating data (See "TECHNICAL CHARACTERISTICS OF THE PRESSURE REDUCING
VALVE"). The device fitted downstream of the valve must be able to withstand twice the pre-calibrated outlet
pressure (See "FUNCTIONING" paragraph) of the valve (P
with the valve may cause excessive or insufficient flow of gas to patient.
Cod. 2379446342 Rev.B6 Index 15648 - 08/2016
Consult
instructions for
use
Production lot
Hazard
Upper
temperature
limit
). Non-compatibility of the medical device components
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www.cavagnagroup.com
Manufacturer
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