Philips Avalon FM20 - Tympanic Temperature

12 Specifications
236
Tympanic Temperature
Complies with:
• EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers)
• ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient
Temperature)
with minor exceptions as noted below.
The fetal monitor additionally complies with ISO 80601-2-56:2009 / EN ISO 80601-2-56:2012
Bradycardia Difference to low limit 0—50 bpm 5 bpm steps max. 14 seconds
Clamping at 30—100 bpm 5 bpm steps
SpO
2
Alarm Specifications Range Adjustment Delay
Performance Specifications
Temperature Resolution 0.1°C or 0.1°F
Response Time less than 2 seconds
Temperature Calibrated Accuracy Specifications (out of the Factory)
Ambient Temperature Target Temperature Accuracy
25.0°C (77.0°F) 37.7°C—38.9°C (98.4°F—102.0°F) ±0.1°C (±0.2°F)
16.0°C—33.0°C (60.8°F—
91.4°F)
33.0°C—42.0°C (91.4°F—107.6°F) ±0.2°C (±0.4°F)
Temperature Calibrated Accuracy Specifications (after recalibration using Genius 2 Checker/Calibrator)
Ambient Temperature Target Temperature Accuracy
16.0°C—33.0°C (60.8°F—
91.4°F)
36.0°C—39.0°C (96.8°F—102.2°F) ±0.2°C (±0.4°F)
16.0°C—33.0°C (60.8°F—
91.4°F)
<36.0°C or >39.0°C
(<96.8°F or >102.2°F)
±0.3°C (±0.5°F)
ASTM laboratory requirement for IR thermometers in the display range 37.0°C—39.0°C (98.0°F—102.0°F) is
±0.2°C (±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards
E667-86 and E1112-86 is ±0.1°C (±0.2°F).
Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use
a certified black body as specified in EN ISO 80601-2-56, Annex C, or use a Genius 2 Checker/Calibrator - available
from Covidien llc under part number 303097.
Clinical repeatability: meets section A.5 of EN ISO 80601-2-56(E) per Covidien llc technical report. Data is available
from Covidien llc on request.
Displayed Temperature Measurement Range
Mode Range °C Range °F
Ear 33.0—42.0 91.4—107.6
Oral (ear + 0.6°C) 33.6—42.0 92.5—107.6
Core (ear + 1.04°C) 34.0—42.0 93.2—107.6