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spirodoc
SPIRODOC cod. 980156 Rev 2.4 EN 6/46
User manual
If an oximetry sensor appears damaged, do not use it. Use another oximetry sensor or contact your authorized repair center for
assistance.
Use only MIR oximetry sensors supplied with, or specifically intended for use with SPIRODOC. Use of oximetry sensors not intended for
use with the SPIRODOC may cause inaccurate readings.
Oximetry measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a surgical towel, for
example) if necessary.
WARNING
Dyes introduced into the bloodstream (for example; to perform a diagnostic tests) such as methylene blue, indocyanine green, indigo
carmine, patent blue V (PBV), and fluorescein may adversely affect the accuracy of the oximetry reading.
Any condition that restricts blood flow, such as the use of a blood pressure cuff or a device for systemic vascular resistance, may cause
the inability to determine accurate pulse rate and SpO2 readings.
Remove fingernail polish and/or false fingernails before applying SpO2 sensors. Both may cause inaccurate oximetry measurements.
Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, may adversely affect the accuracy of
the oximetry measurement.
Optical cross-talk can occur when two or more sensors are placed in close proximity. Optical cross-talk may adversely affect the
accuracy of the oximetry readings. The danger can be eliminated by covering each site with opaque material.
Obstructions or dirt on the sensor’s emitter and/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, may cause sensor damage. Do not attempt to sterilize the sensor.
Unplug the sensor from SPIRODOC before cleaning or disinfecting to prevent damaging sensor or device, and to prevent safety hazards
for the user.
1.2.5 Device
WARNING
The maintenance operations detailed in this manual must be fully and accurately carried out. If these instructions are not followed this
may cause measurement errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfigurations must be made by the manufacturer or by personnel authorised by the
manufacturer. Never attempt to make a repair on your own. The set-up of configurable parameters should only be made by qualified
personnel. However, an incorrect set-up of the parameters in no way endagers the patient
’s health.
High-
frequency emissions from “electronic” devices may interfere with the correct operation of the device. For this reason, certain
minimum clearances (a few meters) 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 device may give inaccurate readings if operated in the presence of strong electromagnetic sources, such as electrosurgical
equipment, or in the presence of computed tomography (CT) equipment.
The use of accessories and cables other than those specified by the manufacturer may result in increased emissions or decreased
immunity of the device.
SPIRODOC should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, SPIRODOC
should be observed to verify normal operation in the configuration in which it will be used.
Do not use the device in the presence of magnetic resonance imaging (MRI) equipment. MRI equipment may cause an induced current to
the oximetry sensor, resulting in patient injury.
If the device is connected to other instruments, to satisfy the safety requirements of the system required by the standard CEI EN 60601-1,
it is necessary to use exclusively devices compliant to the safety standard. Therefore the PC or the printer which the SPIRODOC is
connected must be compliant to the standard CEI EN 60601-1.
To dispose of the SPIRODOC, the accessories, any plastic consumable materials (mouthpieces) as well as the battery, use only
appropriate containers or return all such parts to the dealer or to a recycling center. All applicable local regulations must be followed.
If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages, however caused.
To supply power to the device use only the battery type indicated in the § Technical specifications.
The device may be powered through a PC by a USB cable. By this means, the device works both on line with the PC, or individually
powered by the PC.
Keep the device out of reach of children and of any person with mental handicap.
1.3 Lithium-ion battery pack warning
The device is powered by a rechargeable lithium-ion battery pack with a supply voltage of 3.7 V.
For proper use of the battery pack please read carefully the warning below
WARNING
Use only battery packs supplied by MIR
Improper use of the battery pack may cause acid leakage, overheating, smoke, breakage an explosion and/or fire. Consequently the
battery pack may be damaged or suffer a drop in overall performance. The internal battery pack safety sensor could also be damaged as
well by any of the above events. Furthermore the user of the device could be harmed and other nearby appliances could be damaged as
well.
Please read the following instructions carefully.