Symbols And Trademarks; Information For The User Regarding The Radio Communication Part Of The Tonometer; Bluetooth Module Information; Statement Of Compliance - Icare HOME2 Instruction Manual

level Device N Mean
(mmHg)
7 mmHg HOME2 180 7.81
ic200 180 7.60
10 mmHg HOME2 180 10.10
ic200 180 10.13
20 mmHg HOME2 180 20.42
ic200 180 20.36
30 mmHg HOME2 180 31.33
ic200 180 31.47
40 mmHg HOME2 180 39.71
ic200 180 39.81
50 mmHg HOME2 180 50.56
ic200 180 50.57
17.8

Symbols and trademarks

Caution
Consult
instructions
for use
Serial number
Single use
Do not re-use
Use by
IP22
Protected
against access to
hazardous parts
with a finger.
Protected against
solid foreign
objects of
12,5 mm ∅ and
greater. Protected
against vertically
falling water drops
when enclosure
tilted up to 15°.
Type BF applied
part
Rx Only (U.S.)
Federal law (U.S.)
restricts this
device to sale by
or on the order
of a physician or
properly licensed
practitioner.
40
StDev CV% Difference 95% LoA
(mmHg) HOME2 -ic200 HOME2-ic200
(mmHg) (mmHg)
0.39 5.0% 0,21 -0.57...1.00
0.18 2.4%
0.34 3.3% -0,03 -0.70...0.64
0.28 2.8%
0.55 2.7% 0,06
0.46 2.3%
0.71 2.3% -0,14 -1.56...1.28
0.63 2.0%
0.73 1.8% -0,10 -1.56...1.36
0.73 1.8%
1.05 2.1% -0,01
1.02 2.0%
Batch code
LOT number
Date of manufacture
Sterilized using
irradiation
Keep dry
Non-ionizing
electromagnetic
radiation
Manufacturer
EU WEEE (European
Union Directive for
Waste of Electronic
and Electrical
Equipment) symbol.
Do not dispose of
this product with
household waste.
Send to appropriate
facility for recovery
and recycling.
Bluetooth
communication
-1.04...1.16
-2.11...2.09
17.9 Information for the user regarding the radio
communication part of the tonometer
The iCare HOME2 tonometer contains a Bluetooth transmitter working at
frequencies between 2.402 GHz and 2.480 GHz. Due to the limited physical
size of the tonometer, many of the relevant approval markings are found in
this document.

17.10 Bluetooth module information

Item
Bluetooth module
Communication
Radio Frequency (RF) range
Output power
Antenna gain
Effective radiated power
Transmitting distance
FCC ID: A8TBM78ABCDEFGH
IC: 12246A-BM78SPPS5M2
MIC: 202-SMD070

17.11 Statement of compliance

This device complies with Part 15 of the FCC rules and RSS-210 of Industry
Canada. Operation is subject to the following two conditions:
• This device may not cause harmful interference,
• This device must accept any interference received, including interference
that may cause undesired operation
Changes or modifications not expressly approved by Icare Finland Oy could
void the user's authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in
a residential installation. This equipment generates, uses and can radiate
radio frequency energy, and if not installed and used in accordance with
The Regulatory
Compliance Mark
(RCM), in Australia
and New Zealand
Refer to the
instruction manual
Temperature limit
Atmospheric
pressure limitation
CE mark
Specification
RN4678 Bluetooth 4.2 Dual Mode
Bluetooth Low Energy (LE)
2.402 GHz – 2.480 GHz
< 2.5 mW (4 dBm), Class 2
1.63 dBi
< 2.2 mW (3.4dBm)
10 meters (30 feet)
Technical conformity
mark and
certification number
of the Ministry of
Internal Affairs and
Communications of
Japan (MIC)
Product is a medical
device
Humidity limitation
Recyclable package
material
41