4
performance, there are certain safety issues need attention to when use the
device, please follow the following guidance carefully:
Do not sprinkle water or any liquids on the device;
Keep your portable spirometer dry and avoid exposing it to extremes in
temperature or humidity;
Do not damage the
UBREATH® PRO
Spirometer System;
Keep the Spirometer System and all associated parts out of reach of children;
Use only original disposable and accessories from manufacturer;
Device rechargeable lithium battery life is 500 complete recharge cycles.
WARNING:
The thermal paper used for printing is highly inflammable. Keep
away from open flames.
Accessory to Medical Equipment (IEC 60601-1)
Accessory equipment connected to this product must be certified according to
the respective IEC standards (i.e.,60601-1) for medical equipment. Furthermore,
all configurations shall comply with the system standard IEC 60601-1-1. Anyone,
who connects additional equipment to the signal input part or signal output part
configures a medical system, and it therefore responsible that the system
complies with the requirements of system standard IEC 60601-1-1. Whoever is
responsible for securing the unit to a system needs to ensure that the mounting
equipment used with this product complies to IEC standard 60601-1. If in doubt,
consult the technical services department or your local dealers.
1.7 Cross-Contamination
To avoid exposing the subject to the critical danger of cross-contamination, a
single disposable mouthpiece as well as a flow transducer are required to
connect a subject to the spirometer.
WARNING:
It is importance to use a new flow transducer and mouthpiece for
each subject for every pulmonary function test. The characteristics, accuracy
and the hygiene of the disposable transducer or mouthpiece can only be
guaranteed if it has been conserved beforehand in its original sealed
packaging. The disposable mouthpiece / flow transducer both are made of
plastic and its disposal after use must adhere to the local regulations and
norms in force.
To avoid incorrect functioning and possible damages, do not allow dust or
any impurities such as hair, sputum, threads etc. to enter the sensor.
WARNING:
It is highly recommended to use gloves when replacing disposable
flow transducers and mouthpieces and washing hands after touching them.
