Vitalograph 4300 Peak Flow Meter Instruction Manual
- October 30, 2023
- Vitalograph
Table of Contents
Vitalograph 4300 Peak Flow Meter
Product Information
The peak flow meter is a medical device that measures peak expiratory flow (PEF) for adults and pediatric patients aged 5 years and older. It is primarily used in primary care, clinics, hospitals, and at home under the supervision of a healthcare professional. The device comes with instructions for use and a stylus for setting action zones. The device should be cleaned after each use, and the outer surfaces should be wiped with an alcohol wipe (IPA 70%). The device and its accessories constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements.
Product Usage Instructions
- To set action zones, use the stylus provided to mark personal boundaries for implementing the asthma action plan.
- To use the peak flow meter, slide the pointer to the bottom of the scale.
- Hold the device horizontally in front of your mouth.
- Inhale as deeply as possible.
- Seal your lips firmly around the mouthpiece.
- Blow out as hard and as fast as possible for a second or longer. Take care that your tongue or teeth do not obstruct the airflow. A “spitting” action or coughing will give false readings.
- Take note of the reading.
- Repeat steps 1 to 7 three times and record the highest reading.
- Take action according to your personal asthma management plan.
Note : The device is guaranteed for one year, except for accidental/transit damage or inappropriate use of the device. Replace the unit every three years.
Instructions for Use
Setting Action Zones
Zone markers may be set with a stylus by the healthcare professional to give
personal boundaries for implementing the asthma action plan.
To Use Peak Flow Meter
- Slide pointer to the bottom of the scale.
- Hold device horizontally in front of your mouth.
- Inhale as deeply as possible.
- Seal your lips 昀椀rmly around the mouthpiece.
- Blow out as HARD and as FAST as possible for a second or longer.
- Take care that tongue or teeth do not obstruct the air flow. A ‘spitting’ action or coughing will give false readings.
- Take note of the reading.
- Repeat steps 1 to 7 three times and record the highest reading.
- Take action according to your personal asthma management plan.
Cleaning
Clean the outer surfaces after use. We recommend using an ordinary alcohol
wipe (IPA 70%). Pay special attention to the mouthpiece area.
Indications For Use
Device measures peak expiratory 昀氀ow (PEF) for use on adults and
paediatrics, 5 years and older, in primary care, clinics, hospitals and at
home, under the supervision of a healthcare professional.
Use In Clinic
When used for multiple subjects Vitalograph® intends that a mouthpiece adaptor
(available as an accessory) and disposable Bacteria/Viral Filter (BVF™) be
used. The Peak Flow Meter should be externally cleaned between each patient.
Cat. No 28501: EcoBVF – Bacterial/Vital Filter (100)
Disposal
The peak flow meter and its accessories constitute minimally soiled waste from
human healthcare and should be disposed of in line with local requirements.
Peak Flow Meter ABS
Contraindications, Warnings, Precautions and Adverse Reactions
Note : Please read all this information before using this Peak Flow
Meter.
- When used for multiple subjects Vitalograph intends that a new BVF be used for every subject to prevent cross contamination. Using a new BVF provides a significant level of protection of the subject, the device and the user against cross-contamination. A BVF is for single use only.
- This device is intended to help you assess how well your asthma is under control, by measuring your peak flow which can then be monitored over time.
- Never attempt to dismantle the unit. This can cause faulty Peak Expiratory Flow scores.
- If used at home symptoms must take precedence over 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 symbol indicates compliance of this 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 classified 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 Specifications
- 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: Profile A/B difference less than 15 L/min or 12% (EN ISO 23747:2015)
- Highest resistance to flow: 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)
- Package Contents: Peak Flow Meter, Instructions for Use
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