eResearchTechnology GmbH AM3G01 사용자 설명서
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Peak Flow Meter AM3 - Instructions for Use for Trial xxx
Version 00.03 • Date 04NOV2013
Table of Contents
Indications for Use ................................................................................................ 4
ERT Customer Care Contacts ................................................................................ 5
ERT Toll-Free Hotline ............................................................................................. 6
Notes on Safety in Instructions for Use .................................................................. 7
Declaration of Conformity ..................................................................................... 7
1.
ERT Customer Care Contacts ................................................................................ 5
ERT Toll-Free Hotline ............................................................................................. 6
Notes on Safety in Instructions for Use .................................................................. 7
Declaration of Conformity ..................................................................................... 7
1.
2.1.1 Turning the Device ON in Subject Mode .................................................. 10
2.1.2 Turning the Device ON in Investigator Mode ........................................... 10
2.1.3 Turning the Device OFF ........................................................................... 10
2.1.4 TUTORIAL Devices ................................................................................... 10
2.1.5 New Subject Devices ............................................................................... 11
2.1.6 Assigned Subject Devices ........................................................................ 11
2.2
2.1.2 Turning the Device ON in Investigator Mode ........................................... 10
2.1.3 Turning the Device OFF ........................................................................... 10
2.1.4 TUTORIAL Devices ................................................................................... 10
2.1.5 New Subject Devices ............................................................................... 11
2.1.6 Assigned Subject Devices ........................................................................ 11
2.2
2.2.1 Preparing for the Measurement .............................................................. 11
2.2.2 Performing Scheduled Sessions ............................................................... 12
2.2.3 How to Perform PEF Measurements with the AM .................................... 12
2.2.4 Validity of PEF Measurements ................................................................. 13
2.2.5 Interrupting a Scheduled Session ............................................................ 14
2.3
2.2.2 Performing Scheduled Sessions ............................................................... 12
2.2.3 How to Perform PEF Measurements with the AM .................................... 12
2.2.4 Validity of PEF Measurements ................................................................. 13
2.2.5 Interrupting a Scheduled Session ............................................................ 14
2.3
3.1.1 Cleaning the Disposable Mouthpiece/Rotary Flow Sensor ........................ 20
3.1.2 Cleaning the Case .................................................................................. 20
3.1.3 Checking the Sensor ............................................................................... 20
4.
3.1.2 Cleaning the Case .................................................................................. 20
3.1.3 Checking the Sensor ............................................................................... 20
4.
Literature ............................................................................................................ 30
Notes on EMC according to EN60601-1-2 ........................................................... 31
Return of Goods in Medical Institutions ............................................................... 35
Technical Data .................................................................................................... 39
Index .............................................................................................................. 41
Notes on EMC according to EN60601-1-2 ........................................................... 31
Return of Goods in Medical Institutions ............................................................... 35
Technical Data .................................................................................................... 39
Index .............................................................................................................. 41
This document contains copyright information. All rights are reserved. It is
not allowed to copy, duplicate or translate this manual in any other language
without having the written approval of ERT before. ERT reserves the right to alter
the information included in this document without notice. Names of persons
mentioned in the context of this manual are fictitious - any resemblance to living
or deceased persons is purely incidental and not intended.
Subject to technical modifications.
not allowed to copy, duplicate or translate this manual in any other language
without having the written approval of ERT before. ERT reserves the right to alter
the information included in this document without notice. Names of persons
mentioned in the context of this manual are fictitious - any resemblance to living
or deceased persons is purely incidental and not intended.
Subject to technical modifications.