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Vitalograph 4300 User Manual

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Universal For Adults & Children | Universal Für
Erwachsene & Kinder | Universel pour adultes
et enfants | Universale per adulti e bambini
Medical Device | Medizinisches Gerät
Dispositif médical | Dispositivo medico
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Vitalograph 4300 Specifications

General IconGeneral
Flow Accuracy±5% or 0.2 L/s, whichever is greater
Device TypeSpirometer
Parameters MeasuredFVC, FEV1, PEF, FEV1/FVC, FEF25-75%, FET
DisplayLCD
Volume Accuracy±3% or 50 mL, whichever is greater
ComplianceATS/ERS 2005
ConnectivityUSB, Bluetooth, Wi-Fi

Summary

Vitalograph Peak Flow Meter Model 4300 Instructions

Setting Action Zones

Zone markers set by healthcare professionals for personal asthma action plan boundaries.

How to Use the Peak Flow Meter

Step-by-step guide on how to use the peak flow meter for accurate readings.

Cleaning and Maintenance

Instructions for cleaning the outer surfaces and mouthpiece area with alcohol wipes.

Indications for Use

Specifies the device measures PEF for adults/paediatrics (5+ years) in various healthcare settings.

Clinic Use Recommendations

Recommends adaptor and filter for multi-subject use and external cleaning between patients.

Disposal Guidelines

Guidance on disposing of the device and accessories as minimally soiled medical waste per local requirements.

Contraindications, Warnings, Precautions and Adverse Reactions

Crucial safety information, including cross-contamination prevention, handling, and potential issues.

Product Warranty Information

Details the one-year warranty and replacement policy for the device, excluding accidental damage.

CE Marking Compliance

Explains the meaning of the CE symbol indicating compliance with the Medical Devices Directive.

FDA Regulatory Notice

States Federal Law restricts device sale to physician order, highlighting regulatory control.

Declaration of Conformity

Vitalograph declares the product meets QMS regulations and standards like MDD and ISO 13485.

Technical Specifications

Lists detailed product specifications, accuracy, repeatability, measurement range, and performance standards.

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