Applied Standards; Warranty - B.Well PRO-110 Instructions For Use Manual

Instruction for Use
Durable periods:
Durable periods are as follows, provided the product is used to nebulize 2ml of medica-
tion 2 times a day for 5 minutes each time at room temperature (23°C).
Durable period may vary depending on usage environment.
Compressor (main unite) ≥ 10 years (or ~1000 hours)
Nebulizer kit, air tube, mouthpiece, nosepiece, masks – 1 year
Air filter – 60 days
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The information defined above is advisory and can change depending on physical prop-
erties (temperature, viscosity, density) of the nebulized substance.
The manufacturer may change technical specifications and design of the device without
prior notice.

13. APPLIED STANDARDS

Electric Safety Standards EN 60601-1. Electromagnetic Compatibility according
to EN 60601-1-2. Class IIa Medical Device according to the 93/42/EEC European Directive
on Medical Devices.
This device fulfils the provision of the EC directive 93/42/EEC (Medical Device Directive)
and the European Standard EN 13544-1:2007+A1:2009 Respiratory therapy equipment -
Part 1: Nebulizing systems and their components.

14. WARRANTY

Warranty period is 3 years from the date of purchase.
This warranty doesn't cover any damages caused by improper using, and also battery,
protective cover and storage bag, packaging and the accessories supplied with the
device (nebulizer kit, air tube, mouthpiece, nosepiece, masks, air filters) and those parts
subject to normal wear and tear.
The warranty does not apply to damage caused by using adapters not recommended by
the B.Well company and the overvoltage.
When a manufacturing defect is revealed during the warranty period a faulty unit would
be repaired or, if repairing is impossible, replaced with another one.
The manufacturer may change units partially or completely if necessary, without prior
notice.
Manufacturing date is encoded in the SN number at the bottom of the device: two first
numbers are numbers of the week; two other numbers are last numbers of the year.
Manufacturing date of the spare parts, which can be bought separately from the device
is encoded in the LOT number on the sticker: two first numbers are numbers of the
week, two other numbers are last numbers of the year.
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Class II device as regards protection against electric shocks.
Nebulizer, mouthpiece and masks are type BF applied parts.
Device not protected against sprinkles.
Device for intermittent use (30 min ON / 30 min OFF)
PRO-110 / PRO-115
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