Hetaida HTD8823US - Equipment Classification and Standards; Safety Standards and Certifications; Performance Indicators; ME Equipment Safety Classification

Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
8 / 18
8
Equipment classification
Safety Standards:
ANSI AAMI ES60601-1: 2005/(R)2012 and A1:2012
IEC 60601-1-2: 2015
Type of protection
Internally powered equipment (on battery power)
Front panel and case
labeling
ISO 15223-1 : 2016
Performance
ASTM E1965-98 (2016)
Home healthcare
environment
IEC 60601-1-11 : 2015
Calculated values of the indicators according to ISO 80601-2-56
Indicators
Forehead mode
Forehead Scan mode
Group I
(Infants)
Group II
(Children)
Group III
(Adults)
Group I
(Infants)
Group II
(Children)
Group III
(Adults)
Clinical Bias
0.18
0.17
0.17
0.16
0.16
0.15
Uncertainty
± 0.11
± 0.10
± 0.10
± 0.09
± 0.08
± 0.08
Clinical repeatability, S
r
0.13
0.12
*Infants except less than or equal to 28 days of age
Safety classification of ME EQUIPMENT
2- Operation
2.1 Battery installation
Caution: The Non Contact Infrared Body Thermometer does not operate with dead
batteries and does not input outer power. Install new batteries.
1) Pull the battery downward, toward the bottom of the Non Contact Infrared Body
Thermometer, and remove the battery access door;
2) Insert two pieces AAA size batteries according to the “+” and “-”;
3) Close the battery cover.
2.2 How to Operate
Before Applying the Thermometer
Be sure to read and understand all warnings listed of the instructions before use.
Protection against electric shock
Internally powered ME
equipment
Applied part
Non Applied part
Protection against harmful ingress of water or
particulate matter
IP22
Mode of operation
Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT