eResearchTechnology GmbH AM3G01 User Manuals

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. The Ambulatory Monitoring Equipment

  8
• 2. The Peak Flow Meter AM3

  8
• 2.1 Handling

  10
• 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 PEF Measurements with the AM

  11
• 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 Performing Unscheduled/Optional PEF Measurements

  14
• 2.4 Device Settings (Service Mode)

  15
• 2.5 Power Management

  17
• 2.6 Memory Capacity

  18
• 3. Cleaning

  19
• 3.1 Disposal of Sensor

  19
• 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. Error Checklist

  21
• 5. General Safety Precautions

  22
• 5.1 Safety Precautions for Lithium Ion Rechargeable Batteries

  25
• 5.2 Safety Precautions for GSM Option

  26
• Literature

  30
• Notes on EMC according to EN60601-1-2

  31
• Return of Goods in Medical Institutions

  35
• Technical Data

  39
• Index

  41