The Instrument - MIR Spirodoc User Manual

Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, will affect the accuracy
of the oximetry measurements.
Optical cross-talk can occur when two or more sensors are placed in close proximity. This can be eliminated by covering
each site with opaque material. Optical cross-talk may adversely affect the accuracy of the SpO2 readings.
Obstructions or dirt on the sensor's red light or detector may cause a sensor failure or inaccurate readings. Make sure
there are no obstructions and the sensor is clean.
Autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid may cause sensor damage which may result in
inaccurate readings.
Unplug the sensor from the monitor before cleaning or disinfecting to prevent damaging sensor or monitor, and to
prevent user safety hazards.
1.2.5

The instrument

WARNING
The maintenance operations detailed in this manual must be carried out precisely. If these instructions are not
followed this can cause measurement errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfiguration must be made by the manufacturer or by personnel
authorised by the manufacturer. Never attempt to make a repair oneself.
The set-up of configurable parameters should only be made by qualified personnel. However, an incorrect set
up of the parameters does not put the patient at risk.
High-frequency emissions may interfere with the correct operation of the instrument. For this reason, certain
minimum clearances (a few metres) should be observed when high-frequency appliances such as a TV, radio,
portable phone etc and other electronic units are operated at the same time in the same room.
The instrument may give inaccurate readings in the presence of strong electromagnetic sources, such as
electrosurgery equipment.
The instrument may give inaccurate readings in the presence of computed tomography (CT) eqipment.
Do not use the instrument in the presence of magnetic resonance imaging (MRI) equipment. MRI equipment may
cause induced current to the SpO2 sensor resulting in patient injury.
If the instrument is connected to any other instrument then, in order to maintain the essential safety
characteristics laid down by IEC 60601-1-1 only equipment which complies to the current safety regulations may
be used.
For the recycling of the spirodoc, accessories, plastic consumable materials (mouthpieces) plus the battery, use only
the appropriate containers or return all such parts to the seller of the instrument or to a recycling centre. All appropriate
local regulations must be followed.
Use only a battery of the type indicated in the § Technical specifications. Remove the battery from the device if the
machine is not used for a long period (several months).
Keep the device out of reach of children and of any person with mental handicap.
1.3 Unforeseen errors
In the case of a problem, one of a series of messages to indicate the nature of the problem will appear on the screen
together with a warning "beep".
Operation of this device beyond its declared life (see the relevant paragraph in the Technical Characteristics) could
provoke a loss of data in the memory of the device (SRAM memory) .
Errors in measurement or in interpretation can also be caused by:
• use by non-qualified or non-trained personnel, lacking ability or experience
• user error
• use of the instrument outside the guidelines described in this User' s Manual
• use of the instrument even when some operational anomalies are encountered
• non-authorised servicing of the instrument
1.4 Labels and symbols
1.4.1 Identification label
This label contains:
•
Product name
•
Serial number of the device
spirodoc user manual code 980165
0476 0476
Rev 4.5 page 6 of 27