Microlife PF 200 BT handleiding

Handleiding

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2. Important information

Device description

Microlife digital peak flow meter is a medical device that utilizes the principles of flow

turbine, with optical interruption detection and digital signal processing, to compute and

provide a measurement of peak expiratory flow and other pulmonary functional parame-

ters. Measuring your pulmonary functions, as instructed by your physician or other qual-

ified healthcare professionals, is useful for monitoring your airway and lung conditions or

diseases.

Intended purposes

This device is intended to measure the following pulmonary function parameters:

 Peak Expiratory Flow (PEF): The maximum flow rate a person can exhale forcibly

after taking a deep as possible breath.

 Forced Expiratory Volume 1-Second (FEV1): The air volume of forcible exhalation a

person can exhale in 1 second after taking a deep as possible breath.

Intended user

The device is intended to be operated by adult users with the vision and motor functions

as well as the literacy and basic education, capable of understanding the content of this

instructions for use and operating general household electrical appliances, for use of

self-monitoring or monitoring of other subjects.

Intended patient

The device is intended for measurements of pediatric and adult subjects.

Intended use environment and conditions

The device is intended for use in a home healthcare environment (for example general

household) and professional healthcare environment by patients (for self-measurement)

or by a care giver.

Indications

This device has the indications of:

 Asthma

 Chronic bronchitis

 Chronic Obstructive Pulmonary Disease (COPD)

 Other respiratory diseases or conditions affecting airway flow, as instructed by

healthcare professionals

Contra-indications

The device is not suitable for subjects who are unable to conduct the measurement

correctly, for example:

 Patients unconscious or in disabling conditions that does not allow correct self-

measurement operating conditions.

 Bedridden patients unable to stand or sit upright as required for correct measure-

ment.

 Patients whose mouth cannot cover the mouthpiece as required for correct measure-

ment.

Warning

 DO NOT use this device for purposes beyond described in this instructions for use.

The manufacturer cannot be held liable for damage caused by incorrect application.

 Inspect the device and other parts for damage. DO NOT USE the device or parts if

they appear damaged or operating abnormally.

 DO NOT use this device in oxygen rich environment or near flammable gas.

 Do not use this device in a moving vehicle (for example in a car or on an aircraft).

 Keep the device away from children and people incapable of operating the device.

Beware of the risks of accidental ingestion of small parts and of strangulation with the

cables and tubes of this device and accessories.

DO NOT let children operate the device alone.

 The measurement result of this device is not a medical diagnosis and not intended

to substitute consultation and diagnosis by a qualified professional healthcare

provider (e.g., physician, pharmacist, or other licensed health-care professionals).

Do not use this device for self-diagnosis or for self-treatment of a medical condition.

Seek advice from a health-care professional immediately if the patient is clearly

unwell and/or having physiological or medical symptoms.

 DO NOT change the patient medication and treatment based on the result of one or

multiple measurements. Treatment and medication changes should be prescribed

only by a medical professional.

 Use and store the device and parts in temperature and humidity conditions specified

in the «Technical specifications». Usage and storage of the device and parts in

conditions outside ranges given in the «Technical specifications» may result in

device malfunction and/or impact the safety of usage.

Caution

 Protect the device and accessories from the following to avoid damaging the device:

 water, other liquids, and moisture

 extreme temperatures

 impacts and vibrations

 direct sunlight

 contamination and dust

 Stop using this device and consult with your doctor if you experience skin irritation or

discomfort.

 DO NOT use this device or parts after the expiration of its stated service life.

 Do not dissemble or attempt to service the device, accessory and parts, during use

or in storage. Access to the device internal hardware and software is prohibited.

Unauthorized access and servicing of the device, during use or in storage, may

compromise the safety and performance of the device.

 Using non-compatible accessories may compromise the safety and performance of

the device.

 This device is reusable. It is recommended to clean and disinfect the device and the

accessory prior to use if contamination or cross contamination are possible.

 Ensure the device has acclimated to the environment before taking measurement. It

is recommended to wait approximately 4 hours after device storage at the maximum

or minimum storage and transport temperature for device to cool down or warm up.

Electromagnetic compatibility

 This device is compliant with electromagnetic disturbances standard.

 Do not use this device close to strong electromagnetic fields and portable radio

frequency communication devices (for example microwave oven and mobile

devices). Keep a minimum distance of 0.3 m from such devices when using this

device.

 DO NOT use this device in proximity of equipment that may cause electromagnetic

disturbance (EMD), such as high frequency (HF) surgical equipment, magnetic reso-

nance imaging (MRI) equipment, and computerized tomography (CT) scanners. This

device is not certified for operation near these equipments, which may cause device

malfunction and measurement inaccuracies.

 This device features Bluetooth

®

that emits radio frequency (RF) in the 2.4GHz band.

Do not use this device in locations where RF is restricted (for example, on an

aircraft). Turn off the device and remove the power source if necessary when in RF

restricted locations.

 This device operates in an unlicensed ISM band at 2.4GHz. In case this device is

used near other wireless devices (for example wireless LAN) which operates on the

same frequency band as this device, there is a possibility that interference may

occur. If interference occurs, stop the operation of other devices or relocate this

product away from other wireless devices before using it.

Indicates a potentially hazardous situation which, if not avoided, may result in

minor or moderate injury to the user or patient, or cause damage to the device

or other property.

Indicates a potentially hazardous situation, which if not avoided, could result in

death or serious injury.

Further documentation in compliance with EN 60601-1-2 EMC standard is

available from Microlife on

www.microlife.com/electro-magnetic-compatibility.

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