Chic ThermoFamily Gebrauchsanweisung Seite 4

NOTE:
Whether the reading is human or object, the oldest reading will be cleared.
CLINICAL ACCURACY VALIDATION METHOD
This device is a clinical thermometer with operating modes. The validated data on clinical accuracy in each 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
The temperature measured is higher than
1. Human thermometer mode: 43°C (109.4°F)
2. Object temperature mode: 100°C (212.0°F)
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)
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 year.
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.
ThermoFamily 00009222000000 is designed for use in an electromagnetic environment that meets the specifications provided below.
The person who purchased or who uses ThermoFamily
environment that complies with said specifications.
Guidance and manufacturer's declaration - Electromagnetic emissions
Phenomenon
Conducted and radiated RF EMISSIONS
Harmonic distortion
Voltage fluctuations and flickering
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
Basic EMC standard or test
Phenomenon
method
ELECTROSTATIC DISCHARGE IEC 61000-4-2
Radiated RF EM fields IEC 61000-4-3
Proximity fields from RF IEC 61000-4-3
wireless communications
equipment
RATED power frequency IEC 61000-4-8
magnetic fields.
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.
Solution
Operate the thermometer only between the spec-
ified temperature ranges. If necessary, clean the
sensor tip. In the event of a repeated error mes-
sage, contact your retailer or Customer Services.
Operate the thermometer only between the spec-
ified temperature ranges.
00009222000000 is responsible for ensuring that the device is used in an
Professional healthcare HOME HEALTHCARE
facility environment ) ENVIRONMENT
a
CISPR 11
)
a
Group 1 Class B
Not applicable
Not applicable
Immunity test levels
Professional healthcare Home healthcare
facility environment environment
± 8kV contact
± 2 kV, ±4kV ±, ±8 kV, ±15 kV air
10 V/m ) 80 MHz - 2.7 GHz
b
a )
80% AM at 1 kHz
COMPLIANT
NOTE: further information about the distances to be maintained
from portable and mobile radio-frequency communication devic-
es (transmitters) and ThermoFamily 00009222000000 may be
requested by contacting Artsana SpA using the contact informa-
tion included in this booklet. 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.
30 A/m c )
50 Hz or 60 Hz
EXPLANATION OF SYMBOLS
The CE marking with the Registration Number
of the Notified Body. This denotes the com-
pliance of European Medical Device Directive
0598
93/42/EEC.
(93/42/EEC)
European Authorized Representative
Manufacturer's name and address
Follow instructions for use
This product meets the basic safety and essen-
tial performance requirements indicated in the
IP22 conditioning test (protection against solid
IP22
foreign objects of 12.5mm
against vertically falling water drops when en-
closure tiled up to 15°).
Temperature limits
Lot Number
DECLARATION OF EC COMPLIANCE
Hereby, AVITA Corporation declares that the radio equipment type
2014/53/EU, Directive 93/42/EEC and Directivr 2011/65/EU (RoHS). The complete text of the EU Declaration of Compliance is availa at:
http://www.avita.com.tw/download/ThermoFamily_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 appliance. 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=Lead. 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. If dead batteries are collected correctly as separate waste they can be recycled, processed
and disposed of ecologically; this avoids a negative impact on both the environment and human health, and contributes towards the recycling
of the substances contained in the batteries. 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 Artsana SpA 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 800 188 898. Warning! Do not service and/or repair the appliance.
)
a
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
AVITA Corporation 9F, No.78 Sec.1,
Kwang-Fu Rd., San-Chung District,
24158 New Taipei City, Taiwan
Disposal information: Should you wish to dis-
pose of the article, do so in accordance with
current regulations. Details are available from
your local authority.
Caution
Type of protection of applied part against
electric shock, body floating.
SN YYMWWWXXXXX
SN: Product Serial Number
YY: year, M: month, WWW: working sheet,
XXXXX: serial no.
The Bluetooth® combination mark,
and greater and Bluetooth® version v. 4.0
Product catalogue reference code or catalog
number.
Compliance to RED directive 2014/53/EU
(2014/53/EU)
00009222000000 is in compliance with Directive
0598
(2014/53/UE)
(93/42/CEE)
Distributed by:
ARTSANA S.p.A.,
Via Saldarini Catelli 1,
22070 - Grandate (CO) - Italia