Clinical accuracy validation method
NT16B is an adjusted mode clinical thermometer
the validated information for clinical accuracy in each
adjusted mode are:
GroupA1:
∆
cb=-0.01°C, L
A
=0.18, σ
r
=±0.08°C
GroupA2:
∆
cb= 0.06°C, L
A
=0.22, σ
r
=±0.08°C
GroupB :
∆
cb=-0.01°C, L
A
=0.20, σ
r
=±0.07°C
GroupC :
∆
cb=-0.01°C, L
A
=0.18, σ
r
=±0.07°C
cb: CLINICAL BIAS
L
A
: LlMITS OF AGREEMENT
σ
r:
CLINICAL
REPEATABILITY
Cleaning and Disinfecting
For home use device disinfection, 70% Ethanol or Isopropyl
alcohol(available in the pharmacy) can be used.
- Clean the measuring sensor after each use. Use a clean
cloth or cotton bud that can be moistened with 70 % alcohol.
- To clean the entire device, please use a soft cloth slightly
moistened with a mild soapy solution. Under no
circumstances may liquid enter the device. Do not use the
device again until it is completely dry.
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Applied Standards
This product conforms to the provisions of the EC directive
MDD(93/ 42/ EEC). The following standards apply to design
and/or manufacture of the products:
‧ ISO 80601-2-56
Medical electrical equipment -- Part 2-56: Particular
requirements for basic safety and essential performance
of clinical thermometers for body temperature
measurement
‧ IEC/EN 60601-1
Medical electrical equipment- Part 1: General requirement
for safety
‧ IEC/EN 60601-1-2
Medical electrical equipment- Part 2: Collateral standard:
Electromagnetic compatibility - Requirements and tests
FCC Important Information
a. FCC Caution: To assure continued compliance,
(example
–
use only shielded interface cables when
connecting to computer or peripheral devices). Any
changes or modifications not expressly approved by the
party responsible for compliance could void the user
＇
s
authority to operate this equipment.
b. This device complies with Part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any
interference received, including interference that may
cause undesired operation.
c. This device complies with FCC radiation
exposure limits set forth for an uncontrolled
environment. End users must follow the specific
operating instructions for satisfying RF exposure
compliance. This transmitter must not be colocated or
operating in conjunction with any other antenna or
transmitter.
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