Spirobank II
Rev.1.6
Page 15 of 35
User manual
Symbol
Description
Units
T Total
Total test time
hh:mm:ss
T Analysis
Total measurement time (test time minus the zeros)
hh:mm:ss
T<90%
Time with SPO2 below 90%
%-hh:mm:ss
T<89%
Time with SPO2 below 89%
%-hh:mm:ss
T<88%
Time with SPO2 below 88%
%-hh:mm:ss
T<87%
Time with SPO2 below 87%
%-hh:mm:ss
Ev%SPO2<89
SpO2 fall below 89% for at least 20 seconds
/
T<40BPM
Test time with pulse rate <40 BPM
%-hh:mm:ss
T>120BPM
Test time with pulse rate >120 BMP
%-hh:mm:ss
T89%
Time with SpO2<89% for a continuous period of at least 5 minutes
hh:mm:ss
T90%
Time with SpO2<90% for continuous periods of at least 5 minutes with mim value <86% (Nadir)
hh:mm:ss
Measurement method:
Red and infrared absorption
Range of measurement %SpO
2
:
0
–
99% (with 1% increments)
SpO
2
Resolution
1%
%SpO
2
accuracy:
2% between 70-100% SpO2
Average number of heart beats for the %SpO
2
calculation:
8 beats
Range of measurement of cardiac pulse:
30
–
300 BPM (with 1 BPM increments)
Cardiac pulse resolution
1 BPM
Accuracy of cardiac pulse:
2 BPM or 2% whichever is greater
Average interval for the calculation of cardiac pulse:
8 seconds
Signal quality indication:
0 - 8 segments on display
Wavelengths and maximum optical output power average of the oximetry
sensors (919024, 919020)
Red light: 660 nm, 2.0 mW (**)
Infrared light: 905 nm, 2.4 mW (**)
Wavelengths and optical output power of oximetry sensors (Envitec sensors)
Red light: 660 nm, 3.5-4.5 mW (**)
Infrared light: 905 nm, 3.5-4.5 mW (**)
** This information may be useful to the doctor.
1.6.3
Oximetry alarms description
Spirobank II
is equipped with audio and visual alarm indicators to alert the operator to provide prompt patient attention or to abnormal
device conditions.
Spirobank II
detects both patient and equipment alarms. Both, patient alarms and equipment alarms are identified
as
medium priority
as defined in IEC 60601-1-8 standard.
Medium Priority Alarms
Medium priority
alarms signal potential problems with the equipment or other non-life-threatening situations. Medium priority auditiry
alarms are sounded as three beeps.
The
intended operator’s position for correctly perceiving a visual alarm signal is 1 meter.
Alarm Summary
Spirobank II
detects both patient and equipment alarms. Alarm indicators remain active for as long as the alarm condition is present.
WARNING
Verify all alarm settings and limits before oximetry test starts to ensure that they are set as intended.
Setting ALARM LIMITS to extreme values can render the ALARM SYSTEM useless.
A hazard can exist if different presets are used on multiple devices in one care area.
The alarm system provides
medium priority
alarm conditions for:
- Low and high SpO
2
level;
- Low and high Pulse Rate level;
- Sensor is unplugged;
- Finger is not inserted
- Low battery level.
Each alarm condition causes the generation of a
visual alarm
signal. The oximetry tests are intended not to be continuously attended
by an operator in normal use, so additional
auditory alarm
signals are generated.
Patient (physiological) Alarms
If patient SpO
2
or pulse readings are equal to or above the upper alarm limit, or if they are equal to or below the lower alarm limit, the
device will signal a medium priority alarm.
