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Vitalograph asma-1 4000 User Manual

Vitalograph asma-1 4000
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Vitalograph asma-1
TM
User Manual
Model No. 4000
Medical Devices Directive
93/42/EEC L169, Vol. 36.
EN ISO 13485
FDA QSR 21 CFR 820/803
Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland
1

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Vitalograph asma-1 4000 Specifications

General IconGeneral
Modelasma-1 4000
CategoryMedical Equipment
Flow Range0 to 16 L/s
PEF Range0 to 16 L/s
Resolution (Flow)0.01 L/s
Resolution (Volume)0.01 L
DisplayLCD
Power Source2 x AAA batteries
TypeSpirometer
Parameters MeasuredFEV1, PEF
Accuracy (FEV1 and FVC)±3% or 0.05 L, whichever is greater
Accuracy (PEF)±5% or 0.2 L/s
ConnectivityUSB
Battery LifeApproximately 1 year
Operating Conditions (Temperature)10 to 40°C
Operating Conditions (Humidity)10 to 95% RH, non-condensing
Storage Temperature-20°C to 60°C
Standards ComplianceISO 26782
Accuracy (Flow)±5% or 0.2 L/s

Summary

Warnings and Advisory Notices

Main Components of the Vitalograph asma-1™

What Is The Vitalograph asma-1™ Used For?

The Asthma Sufferer

How To Use The Vitalograph asma-1™

Setting Personal Best (Reference) Values

Guide to setting reference values for PEF and FEV1.

Setting Management Zones

Instructions for configuring 3 or 4 zone management plans.

Performing The Test

Reviewing Previous Results

Deleting All Results History

Steps to erase all stored test sessions and data.

Care and Cleaning Of The Vitalograph asma-1™ In Home Use

Cleaning and Disinfecting the Vitalograph asma-1™ In Clinic Use

Table of Materials Used & Cleaning/Disinfection Methods

Consumables, Accessories and Spare Parts

Explanation of Symbols

Technical Specifications

Warranty

Appendices

Quick Start Guide

Visual instructions for basic operations and settings.

Regulatory Notices for the Vitalograph asma-1™

CE Notice

Information regarding CE marking and Medical Devices Directive compliance.

FDA Notice

Regulatory statement from the FDA.

Recommended separation distances between portable and mobile RF communication equipment and the system

Declaration of Conformity

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