Physical characteristics
Medical electrical equipment includes the control unit
and the power supply.
Dimensions of Control Unit
9.3 cm (3.7 in) high, extendable to 11.4 cm (4.5 in) high
7.1 cm (2.8 in) wide, 4.3 cm (1.7 in) deep
Weight of Control Unit
128 g (4.5 oz)
Dimensions of Sensor
4.1 cm (1.6 in) diameter, 0.5 cm (0.2 in) thick
Length of the Sensor Cable
400 cm (158 in)
Classification
Protection against electric shock: Class II Medical
Electrical Equipment with Type CF defibrillation-
proof applied part Protection against ingress of
water: Ordinary equipment (IPX0) Mode of operation:
Continuous operation
MEDICAL—GENERAL MEDICAL
EQUIPMENT AS TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE
WITH ANSI/AAMI ES 60601-
1:2005+ AMD: 2012, CAN/
CSA-C22.2 NO. 60601-1: (2008) +
(2014), IEC 60601-1-6:2010 (Third
Edition) + A1:2013, ISO 80601-2-
56:2009 (First Edition); Control
No.4HZ8
Accuracy
25°C to 43°C ± 0.2°C
Sensor Material
Medical grade foam and adhesive
PET flexible circuit
Recommended Calibration Check
Every 12 months or according to institutional protocol.
Sensor Shelf Life
36 months
Digital Port (used by 3M personnel only)
Serial output 0 [-12 to +12]
Monitor Cable Port
Provides a resistance that corresponds to a
YSI-400 thermistor at the displayed temperature. It is
electrically isolated from the control unit.
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Electrical characteristics
External power supply
100-240 VAC, 50-60 Hz
Output; 5 VDC
Class II, double insulated medical grade
Maximum heating power
2 W
Temperature characteristics
Over-temperature cutoff
43°C - Skin thermistor reading
44.5°C - Heater thermistor reading
Performance characteristics
Clinical thermometer mode of operation
Direct mode
Equilibration time/Response time
Approximately five minutes
Measurement locations
Patient's lateral forehead above the orbital ridge
Measurement range
25°C - 43°C
Measurement readout
Celsius or Fahrenheit
Leakage current
Meets leakage current requirements in accordance
with IEC 60601-1.
Environmental conditions
Ambient temperature range
10°C to 40°C (50°F to 104°F)
Storage and transport temperature range
-20°C to 60°C (-4°F to 140°F)
Store all components at room temperature and in a dry
place when not in use.
Operating humidity
10 to 75% RH, noncondensing
Atmospheric pressure range
80 kPa to 106 kPa (12 PSI to 15 PSI)
Oxygen environment
The sensor only is suitable for use in the presence of an
oxygen enriched environment.