Spirobank II
Rev.1.6
Page 4 of 35
User manual
1.
INTRODUCTION
Configuration
Spirobank II BASIC
Spirobank II
Spirobank II Advanced
Oximetry
✓
spot
Spirometry
FVC-VC
FVC-VC-MVV
FVC-VC-MVV
Rechargeable via USB
✓
✓
✓
Bluetooth
✓
✓
winspiroPRO
✓
✓
✓
✓
yes
optional
no
1.1
Intended use
The
Spirobank II
spirometer and pulse oximeter is intended to be used by a physician, by a licensed healthcare professional or by a
patient under the instruction of a physician or of a licensed healthcare professional.
The device is intended to test lung function and can make:
•
spirometry testing in adult and pediatric patients, excluding infants and neonates
•
oximetry testing in people of all ages.
It can be used in hospital setting, physician's office, factory, pharmacy.
1.1.1
User category
Spirobank II
spir oximeter calculates a series of parameters relating to human respiratory function.
Typically the doctor “prescribes” a spirometry test and is responsible for analysing and checking the results obtained.
1.1.2
Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of the device all require qualified personnel. In the
event that the device is to be operated by a patient, sufficient training must first be given to the patient by the doctor.
WARNING
The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow instructions
and warnings in this manual.
If the user of the device is a person considered to be cognitively impaired the operation of the device must be made under the
supervision and responsibility of the person legally responsible to supervise the cognitively impaired person.
WARNING
When used as a pulse-oximeter, the Spirobank II is intended for spot-checking, overnight sleep screening and/or continuous
monitoring when used by a trained healthcare professional.
1.1.3
Operating Environment
Spirobank II
has been designed for use in hospital setting, physician's office, factory, pharmacy.
The device is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents, nor in the presence
of inflammable anaesthetic gases (oxygen or nitrogen).
The device is not designed to be used in direct air drafts (e.g. wind), sources of heat or cold, direct sunlight or other sources of light or
energy, dust, sand or any chemical substances.
The user and/or doctor is responsible for ensuring that the device is stored and used in appropriate environmental
conditions; in this
regard reference is made to the specifications described in paragraph 1.6.3 below.
WARNING
Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results.
