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device measurements.
• If you think that the device is not reading correctly,
advise your healthcare professional immediately.
• If the device is used for longer than it's speci昀椀ed life, the
accuracy of the device may deteriorate.
• Store in a clean dry place.
• Any serious incident that has occurred in relation
to the device should be reported to Vitalograph or
its Authorized Representative and the Regulatory
Authorities of the country.
Warranty
Your device is guaranteed for one year*. Replace
if it is faulty, otherwise replace the unit every three
years. *Excepting accidental/transit damage or
inappropriate use of the device.
CE Notice
Marking by the
device to the Medical Devices Directive of the European
Community. Such marking is indicative that the device
meets or exceeds the referenced technical standards.
FDA Notice
Caution: Federal Law restricts this device to sale by, or on
the order of a physician.
Declaration of Conformity
Product: Vitalograph Model 4300
Vitalograph hereby ensures and declares that the above
product associated with this user manual, is designed
and manufactured in accordance with the following QMS
regulations and standards:
European Medical Devices Directive 93/42/EEC, as
amended.
This device is classi昀椀ed as 1m per Annex V per Annex VII
section 5 of the MDD Canadian Medical Device Regulation
{CMDR SOR/98-282}
FDA Quality System Regulation {QSR} 21 CFR 820;
EN ISO 13485. Medical devices. Quality management
systems. Requirements for regulatory purposes
Certifying Body {For 93/42/EEC and CMDR}: British
Standards Institute, Certi昀椀cate Nos.
CE 00772, CE 85553, MD 82182.
Technical Speci昀椀cations
Product: Peak Flow Meter
Model Number: 4300
Material: ABS plastic
Accuracy: ± 10L/min or ± 10% of the reading
(EN ISO 23747:2015)
Repeatability: ± 10L/min or ± 5% of the reading
(EN ISO 23747:2015)
Frequency: Pro昀椀le A/B difference less than 15 L/min or
12% (EN ISO 23747:2015)
Highest resistance to 昀氀ow: 0.00377 kPa/L/min @ 720 L/min
Measurement Range: 50-800 L/min BTPS
Operating Temperature Range: ATS/ERS: Limits: 17-37°C.
Design Limits: 10-40°C
Peak Flow Meter performance standards:
EN ISO 23747:2015; ATS/ERS:2019
Designed & Manufactured Under: EN ISO 13485,
FDA 21CFR820, CMDR & JPAL
Size: 138.0mm x 56mm x 23mm
Weight: 78.4g (Net)
symbol indicates compliance of this
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