Spirolab
Rev.1.8
Page 12 of 60
must be performed by qualified staff. The incorrect setting of parameters, however,
will not compromise a patient's state of health.
On request, the manufacturer can provide electrical diagrams, parts lists,
descriptions and calibration instructions to assist the technicians with repairs.
The use of accessories and cables other than those specified by the manufacturer
may result in increased emissions or decreased device immunity.
The spirolab device should not be used close to or stacked with other equipment; if
it must be used close to or stacked with other equipment, spirolab should be
observed to verify normal operation in the configuration in which it will be used.
If the device is used in conjunction with other items of equipment, only equipment
that complies with current safety regulations can be used so as meet the safety
standards laid down by IEC EN 60601-1; consequently, the PC or printer to which
spirolab is connected should comply with IEC EN 60601-1.
As regards the disposal of spirolab devices, accessories, plastic consumables
(mouthpieces), removable components and items that are subject to ageing (e.g.
the battery pack), only use suitable containers or, better, send the materials to the
device retailer or an approved disposal centre. Local legal requirements in force
must be complied with in all cases.
Failure to comply with the above mentioned regulations will relieve MIR of all
responsibility from any direct or indirect claim for damages.
Use only the battery pack specified in § Technical Specifications.
Keep the device out of the reach of children and differently-able persons.
1.2.7
Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones,
cell phones, etc.) medical devices may be subject to electromagnetic interference
caused by other equipment.
Such electromagnetic interference could cause the medical device to malfunction,
such as a lower measurement accuracy than stated, and create a potentially
dangerous situation.
Spirolab complies with the EN 60601-1-2:2015 standard on electromagnetic
compatibility (EMC for electromedical devices) both in terms of immunity and
emissions.
For the correct operation of the device, however, it is necessary not to use Spirolab
near other devices (computers, cordless phones, cell phones, etc.) that generate
strong magnetic fields. Keep these devices at a minimum distance of 30
centimeters. If it is necessary to use it at shorter distances, Spirolab and the other
devices must be kept under observation to verify that they work normally.
Do not use the instrument in the presence of MRI equipment, which can generate
an induced current in the sensor to measure oximetry, causing injury to the patient.
