User's Manual

Spirobank II
Page 7 of 34
Rev.1.1
User manual
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 SPIROBANK II 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.
Do not modify this equipment without authorization of the manufacturer.
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.
Technical description indicates, manufacturer will provide circuit diagrams, component part lists, descriptions, calibration
instructions to assist to service personnel in parts repair.
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.
SPIROBANK II should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary,
SPIROBANK II 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 SPIROBANK II is connected must be compliant to the standard CEI EN 60601-1.
To dispose of the SPIROBANK II, 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