EXPLANATION OF SYMBOLS
0197
(93/42/EEC)
The CE marking with the Registration Number
of the Notified Body. This denotes the com-
pliance of European Medical Device Directive
93/42/EEC.
Disposal information: Should you wish to di-
spose of the article, do so in accordance with
current regulations. Details are available from
your local authority.
European Authorized Representative
Caution
Manufacturer’s name and address
Type of protection of applied part against
electric shock, body floating.
Follow instructions for use
SN YYMWWWXXXXX
SN: Product Serial Number
YY: year, M:month, WWW: working sheet,
XXXXX: serial no.
IP22
This product meets the basic safety and es-
sential performance requirements indicated
in the IP22 conditioning test (protection
against solid foreign objects of 12.5mm
and greater and against vertically falling water
drops when enclosure tiled up to 15°).
The Bluetooth® combination mark,
Bluetooth® version v. 4.0
Temperature limits
Product catalogue reference code or catalog
number.
Batch number or Lot Number
(2014/53/EU)
Compliance to RED directive 2014/53/EU
DECLARATION OF EC COMPLIANCE
Hereby, AVITA Corporation declares that the radio equipment type REF 02009197100000, is in compliance with Directive
2014/53/EU, Directive 93/42/EEC and directive 2011/65/EU (RoHS). The full text of the EU declaration of conformity is available at
the following internet address: http://www.avita.com.tw/download/RED_DoC.pdf
THIS PRODUCT COMPLIES WITH THE DIRECTIVE 2012/19/EU.
The crossed bin symbol on the appliance indicates that the product, at the end of its life, must be disposed of separately from
domestic waste, either by taking it to a separate waste disposal site for electric and electronic appliances or by returning it to
your dealer when you buy another similar appli ance. The user is responsible for taking the appliance to a special waste disposal
site at the end of its life. If the disused appliance is collected correctly as separate waste, it can be recycled, treated and disposed
of ecologically; this avoids a negative impact on both the environment and health, and contributes towards the recycling of the
product’s materials. For further information regarding the waste disposal services available, contact your local waste disposal
agency or the shop where you bought the appliance.
COMPLIANCE WITH EU DIRECTIVE 2006/66 CE
The crossed bin symbol on the batteries or product pack indicates that, at the end of their life, they must not be disposed of
as urban refuse. They must be disposed of separately from domestic waste, either by taking them to a separate waste disposal
site for batteries or by returning them to your dealer when you buy similar rechargeable or non-rechargeable batteries. The
chemical symbols Hg, Cd, Pb, printed under the crossed bin symbol, indicate the type of substance contained in the batteries:
Hg=Mercury, Cd=Cadmium, Pb=Led. The user is responsible for taking the batteries to special waste disposal sites at the end of
their life to allow for their processing and recycling. The correct disposal of your old toy will help prevent potential negative consequences for
the environment and human health and favour the recycling of the materials of which the product is made. Improper disposal of the product
by the user may harm the environment and human health. For further information regarding the waste disposal services available, contact your
local waste disposal agency or the shop where you bought the appliance.
NOTE:
• The Bluetooth® trademark and logos are registered trademarks of SIG. Inc. and any use thereof by PIKDARE is under license.
• Google Play and the Google Play logo are Google Inc. trademarks.
• Apple and the Apple logo are trademarks of Apple Inc., registered in the United States and in other countries. App Store is a
service trademark of Apple Inc. registered in the United States and in other countries.
WARRANTY
The product is guaranteed against any conformity defect in normal conditions of use as provided for by the instructions for use.
The warranty shall not therefore apply in the case of damages caused by improper use, wear or accidental events.
For the duration of warranty on conformity defects please refer to the specific provisions of national laws applicable in the
country of purchase, where provided.
In case of problems concerning settings, maintenance or use of the device, contact your local distributor or the Italian toll-free
number 800 900 080. Warning! Do not service and/or repair the appliance.
NOTE:
All the readings will be cleared no matter record in Human mode or Object mode.
CLINICAL ACCURACY VALIDATION METHOD
The thermometer is an adjusted mode clinical thermometer the validated information for clinical accuracy in each adjusted
mode are:
GroupA1:
Δcb=-0.01°C, LA=0.18, σr=±0.08°C
GroupA2:
Δcb= 0.06°C, LA=0.22, σr=±0.08°C
GroupB:
Δcb=-0.01°C, LA=0.20, σr=±0.07°C
GroupC:
Δcb=-0.01°C, LA=0.18, σr=±0.07°C
cb:
CLINICAL BIAS
LA:
LlMITS OF AGREEMENT
σr:
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.
ERROR CODES
When a malfunction or incorrect temperature measurement occurs, an error message will appear as described below.
LCD Display
Cause
Solution
The temperature measured is higher than
1. Human thermometer mode: 43°C (109.4°F)
2. Object temperature mode: 100°C (212.0°F)
Operate the thermometer only between the spe-
cified temperature ranges. If necessary, clean the
sensor tip. In the event of a repeated error mes-
sage, contact your retailer or Customer Services.
The temperature measured is lower than
1. Human thermometer mode: 34°C (93.2°F)
2. Object temperature mode: 0°C (32°F)
The operating temperature is not in the range
15°C~35°C (59°F~95°F)
Operate the thermometer only between the spe-
cified temperature ranges.
SPECIFICATIONS
• Measuring range:
Human Body: 34°C~43°C (93.2°F~109.4°F)
Object: 0°C~100°C (32.0°F~212.0°F)
• Calibration Accuracy:
Human Body: ±0.2°C (±0.4°F): from 34 to 43 °C (93.2 to 109.4 °F)
Object: < 40°C ± 2°C; >= 40°C ± 5%
• Display resolution:
0.1°C
• Measuring site:
Forehead
• Reference body site:
Ear
• Operating environment:
15°C~35°C (59°F ~ 95°F) with relative humidity up to 95% (non condensing)
• Storage/ Transportation
environment:
-25 to 55 °C (-13 to 131 °F) with relative humidity up to 95% (non condensing)
• Power supply:
2 x 1.5V AAA size alkaline batteries
• Weight:
approx. 80g (with batteries)
• Dimensions:
approx. 52.4mmX44.5mmX129.9mm (L×W×H)
• Operation Distance:
3 cm
• BT module:
MAB40A
• Frequency:
2,402 - 2,480 GHz
• Output power range:
<4 dBm
• It is recommended that the accuracy should be checked by manufacture every 1 years.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according
to the EMC information.
1. Electromagnetic/Radio Frequency Interference (EMC/RFI): Readings may be affected if the unit is operated within a radio
frequency electromagnetic fi eld strength of approximately 3 volts per meter, but the performance of the instrument will not
be permanently affected. Care should be taken to keep the thermometer at least 6 inches away from R/C transmitters to avoid
radio frequency interference.
2. Avoid keeping the thermometer too close to objects that continuously generate high heat (like a hot plate) for long periods
of time, which can cause overheating of the thermometer.
ThermoDiary HEAD
02009197100000 is intended for use in the electromagnetic environment specified below. The customer or the
user of ThermoDiary HEAD
02009197100000 must make sure that it is used in such an environment.
Guidance and manufacturer’s declaration - Electromagnetic emissions
Phenomenon
Professional healthcare
facility environment
a
)
HOME HEALTHCARE
ENVIRONMENT
a
)
Conducted and radiated RF EMISSIONS
a
)
CISPR 11
Group 1 Class B
Harmonic distortion
Not applicable
Voltage fluctuations and flickering
Not applicable
a
) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms
and respiratory treatment facilities in hospital or clinics. The more restrictive acceptance limits of Group 1 Class B (CISPR 11) have been
considered and applied. The equipment is suitable for use in the mentioned environments when directly connected to the Public Mains
Network.
b
) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC MAINS
NETWORK and the power input is otherwise within the scope of the Basic EMC standard.
Guidance and manufacturer’s declaration - Electromagnetic immunity - Enclosure port
Phenomenon
Basic EMC standard or test
method
Immunity test levels
Professional healthcare
facility environment
Home healthcare
environment
ELECTROSTATIC DISCHARGE
IEC 61000-4-2
± 8kV contact
± 2 kV, ±4kV ±, ±8 kV, ±15 kV air
Radiated RF EM fields
IEC 61000-4-3
a
)
10 V/m
b
) 80MHz - 2.7 GHz 80%
AM at 1kHz
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
COMPLIANT
NOTE: Further information about distances to be maintained
between portable and mobile RF communications equipment
(transmitters) and the ThermoDiary HEAD
02009197100000
can be requested from PIKDARE S.r.l. using the contact information
provided in this manual. However, it is advisable to keep the
electromechanical aerosol equipment at an adequate distance of,
at least, 0.5 m from mobile phones or other RF communications
transmitters to minimise possible interference.
RATED power frequency
magnetic fields.
IEC 61000-4-8
30 A/m
c
)
50 Hz or 60 Hz
a
) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited to patient rooms and
respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNITY acceptance limits have been considered and applied.
b
) Before modulation is applied.
c
) This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and sources of power frequency
magnetic fields.
02009197100000
76 009197 100 000
Rev
. 01/2017
Distributed by:
PIKDARE S.r.l.,
Via Saldarini Catelli 10,
22070 - Casnate con Bernate (CO) - Italia
MIB Technology Ltd, JPA Brenson Lawlor House, Argyle Square, Morehampton Road, Dublin 4, Ireland.
0197
(93/42/EEC)
(2014/53/EU)
AVITA Corporation 9F, No.78 Sec.1,
Kwang-Fu Rd., San-Chung District,
24158 New Taipei City, Taiwan
