instruction manual

instruction manual
ENGLISH
U
S ER ’ S A N D MANUAL
M A I N T EN A N C E M A N U A L
INSTRUCTION
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Icare tonometer TA01i manual
 English
TONOMETER
Icare® TA01i
INSTRUCTION MANUAL TA01i-001 EN-3.1
The information in this document is subject to change without prior notice.
In a conflict situation the English version prevails.
0044
This device complies with:
Medical Device Directive 93/42/EEC
Canadian Medical Device Regulations
Copyright © 2015 Icare Finland Oy
Made in Finland
Icare Finland Oy/Tiolat Oy
Äyritie 22, FI-01510 Vantaa, Finland
Tel. +358 9 8775 1150, Fax +358 9 728 6670
www.icarefinland.com, info@icarefinland.com
TABLE OF CONTENTS
Indications for use ...................................................................................................................................................................................................................... 3
Introduction ............................................................................................................................................................................................................................... 3
Safety instructions ...................................................................................................................................................................................................................... 3
Parts of the tonometer ............................................................................................................................................................................................................... 4
Turning the tonometer on and loading the probe ...................................................................................................................................................................... 4
Load the probe in the following way: ................................................................................................................................................................................... 4
Measurement ............................................................................................................................................................................................................................. 4
Display after measurements ...................................................................................................................................................................................................... 5
Other functions .......................................................................................................................................................................................................................... 5
Accessing old measurement value ........................................................................................................................................................................................ 5
Turning the tonometer OFF .................................................................................................................................................................................................. 5
Error messages ..................................................................................................................................................................................................................... 5
Diagram of tonometer functions ................................................................................................................................................................................................ 6
Technical information ................................................................................................................................................................................................................ 6
Performance data....................................................................................................................................................................................................................... 7
Accessories ................................................................................................................................................................................................................................. 7
Maintenance .............................................................................................................................................................................................................................. 7
Replacing the probe base...................................................................................................................................................................................................... 8
Cleaning the probe base ....................................................................................................................................................................................................... 8
Cleaning the tonometer ........................................................................................................................................................................................................ 8
Replacing the batteries ......................................................................................................................................................................................................... 8
Returning the Icare tonometer for servicing /repair ............................................................................................................................................................. 9
Periodic Safety Checks .......................................................................................................................................................................................................... 9
Patents and copyrights ............................................................................................................................................................................................................... 9
Symbols ...................................................................................................................................................................................................................................... 9
Electromagnetic declaration ...................................................................................................................................................................................................... 9
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Icare tonometer TA01i manual
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INDICATIONS FOR USE
The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
INTRODUCTION
The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on a new, patented, induction-based rebound method,
which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic.
Since single-use probes are used for measurement, there is no risk of microbiological contamination. No part of the tonometer or probes are made with
natural rubber latex. Intraocular pressure changes due to the effects of the pulse, breathing, eye movements and body position. Because measurements
are taken using a handheld device in fractions of a second, several measurements are needed to obtain an accurate reading and there fore the software is
pre-programmed for six measurements.
SAFETY INSTRUCTIONS
WARNING
The tonometer must not come into contact with the patient’s eyes, except for the probes, which may do so for a fraction of a second during
measurement. Do not bring the tonometer into contact with the eye or push it into the eye (the tip of the probe should be 4-8mm, or 1/6 – 1/3 inch, from
the eye).
WARNING
The tonometer should only be opened by qualified service personnel. It contains no userserviceable parts, apart from the batteries and a probe base. The
Icare tonometerrequires no routine servicing or calibration other than changing the batteries at least every 12 months or changing or cleaning the probe
base. If servicing is necessary, contact qualified service personnel or your local Icare representative.
WARNING
Never spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Dry any liquid on the surface of
the tonometer immediately.
WARNING
Use of any accessories and cables other than those specified in the manufacturer’s documentation, with the exception of cables sold by the manufacturer
as replacement parts for internal components, may result in increased emissions or decreased immunity of the Icare TA01i tonometer.
WARNING
Use of any accessory or cable with the Icare TA01i tonometer other than those specified may result in increased emissions or decreased immunity of the
Icare TA01i tonometer.
CAUTION
Read this manual carefully, since it contains important information on using and servicing the tonometer.
Retain this manual for future use.
When you have opened the package, check for any external damage or faults, particularly for damage to the case. If you suspect that there is something
wrong with the tonometer, contact the manufacturer or distributor.
Use the tonometer only for measuring intraocular pressure. Any other use is improper and the manufacturer cannot be held liable for any damage arising
from improper use, or for the consequences thereof.
Never open the casing of the tonometer, except for the battery compartment or to change the probe base.
This manual contains instructions for replacing batteries and changing the probe base.
Never use the tonometer in wet or damp conditions.
The probe base, battery compartment cover, screws, collar and probes are so small that a child could swallow them. Keep the tonometer out of the reach
of children.
Do not use the device near inflammable substances, including inflammable anesthetic agents.
Prior to each measurement, check that a new disposable probe from an intact package is being used.
Be sure that the probe contains the small plastic round tip in front.
Certain microbiological agents (e.g. bacteria) can be transmitted from the forehead support.
To avoid this, the forehead support should be cleaned regularly with a disinfectant, e.g. an alcohol solution.
The tonometer conforms to EMC requirements (IEC 60101-1-2: 2001), but interference may occur in it if used near (<1m) a device (such as a cellular
phone) causing high-intensity electromagnetic emissions. Although the tonometer’s own electromagnetic emissions are well below the levels permitted
by the relevant standards, they may cause interference in other, nearby devices, e.g. sensitive sensors.
If the device is not to be used for a long time, we recommend that you remove its AA batteries, since they may leak. Removing the batteries will not affect
the subsequent functioning of the tonometer.
Be sure to dispose of the single-use probes properly (e.g. in a container for disposable needles), because they may contain micro-organisms from the
patient.
Batteries, packaging materials and probe bases must be disposed of according to local regulations.
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Icare tonometer TA01i manual
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CAUTION
Federal law (U.S.) restricts this device to sale by or on the order of a physician.
PARTS OF THE TONOMETER
1. Forehead support
2. Forehead support adjusting wheel
3. Display
4. Collar
5. Selector button
6. Measurement button
7. Probe base
8. Central groove
TURNING THE TONOMETER ON AND LOADING THE PROBE
Place the wrist strap into the wrist strap attachment. Place the wrist strap around your wrist and secure it. The wrist
strap protects the tonometer from dropping onto the floor accidentally. Insert batteries into the tonometer (page 9).
Press the measurement button to turn the tonometer ON. The tonometer display will display all of the LCD segments
(see the figure beside). Check that all of the segments are functional in the four-digit, sevensegment LCD display.
Following a brief pause, the display will show “LoAd,” reminding the user to load the single use probe into the
tonometer prior to measurement.
Load the probe in the following way:
Open the probe tube by removing
the cap and insert the probe into
probe base as shown in the
image. After the probe has been
inserted, be careful not to point it
down before activating the
tonometer in order to prevent
the probe from falling out.
Activate by pressing the
easurement button once and the
tonometer will be ready for
measurement when 00 appears
on the display. After activating
the probe is magnetized and will
not fall out.
To obtain firm
support for the
patient’s
forehead, in order
to obtain an
accurate
measurement at
the right distance,
you can adjust the
forehead support
by turning the
forehead support
adjusting wheel.
MEASUREMENT
Since local anesthetic may lower the tonometer reading, we recommend that
you refrain from using an anesthetic when performing measurements.
Ask the patient to relax and look straight ahead at a specific point. Bring the
tonometer near the patient’s eye. The central groove should be in a horizontal
position, and the distance from the eye to the front part of the collar should
be the length of the collar. In other words, the distance from the tip of the
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Icare tonometer TA01i manual
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probe to the patient’s cornea (see picture) should be 4-8 mm (1/6-1/3 inch).
If necessary, adjust the distance by turning the forehead support adjusting wheel. Press the measurement button lightly to perform the measurement,
taking care not to shake the tonometer. The tip of the probe should make contact with the central cornea. Six measurements are made consecutively.
After each successful measurement, you will hear a short beep. Once the six measurements have been performed, the IOP will be shown on the display
after the ‘P’.
If there is an erroneous measurement, the tonometer will beep twice and display an error message. Press the measurement button to clear the error
message. If several erroneous measurements appear, see error messages (page 10).
To obtain the most accurate reading, six measurements are required, but the result is also displayed after the first measurement, which can usually be
considered valid. The measurement values displayed are average values for all previous measurements (1.-5.). Single measurement values are not shown.
Should there be variation between the measurements, ‘P’ will flash on the display after the sixth measurement.
Following the performance of the entire measurement, a new measurement series can be begun by pressing the measurement button. The tonometer will
then be ready for the next measurement series (00 will show on the display, see page 8).
If the user doubts the validity of the measurement (for example, if the probe made contact with the eyelid, or missed the central cornea etc.), we
recommend that he/she make a new measurement. In addition, when encountering unusual values (for example over 22mmHg or below 8 mmHg) we
recommend the performance of a new measurement to verify the result.
*Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure. Ophthalmologica 1994;208:309-313
DISPLAY AFTER MEASUREMENTS
Before
After the second measurement
After the sixth measurement
00
2.13
P 13
After the sixth measurement, the letter P appears on the display, followed by the IOP (Intraocular pressure) reading.
If the P is blinking, it means that the standard deviation of the measurements is greater than normal.
P_ (line down) The standard deviation of the different measurements has a slightly greater value than normally, but the effect on the result is unlikely to
be relevant.
P-(line in the middle) The standard deviation of the different measurements is clearly greater than normal, but the effect on the result is probably
irrelevant. A new measurement is recommended if the IOP is over 19 mmHg.
P–(line up) The standard deviation of the different measurements is great and a new measurement is recommended.
OTHER FUNCTIONS
Accessing old measurement value
From the starting position, press the right or left selector button
until ‘Old’ appears on the display. Then press the measurement
button. You can now ‘scroll’ through the old values by pressing
the selector buttons (right=older, left=more recent, from 0-9).
To exit the old values search, press the measurement button.
The display will now show the word ‘Old’. Press either selector button to access other functions (00=measurement, End=turning OFF).
Turning the tonometer OFF
Press either selector button until the display shows ‘End‘. Press
the measurement button for two seconds - the display will show
‘byE’ and the tonometer will switch off. The used probe will be
partially ejected. Use the used package to remove it from the
tonometer. Ensure that you dispose of the probe properly.
Error messages
To clear error messages, press the measurement button, after which the measurement can be repeated. The following messages may appear:
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Icare tonometer TA01i manual
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MESSAGE
STATE
DESCRIPTION
bAtt
E 01
The batteries are low.
The probe did not move at all.
E 02
E 03
The probe did not touch the eye.
The probe speed was too low.
E 04
The probe speed was too high.
E 05
E 06
The contact with the eye was too “soft.”
The contact with the eye was too “hard.”
E 07
The probe measurement signal detected by the
tonometer was unusual.
E 09
Bad data.
Replace the batteries.
If this error message is repeated, turn the tonometer so that
the collar faces down for a short time. If the error message is
repeated, remove the probe base and replace it with new ones
(see page 9).
The measurement was taken from too far away.
The measurement was taken from too far away or the
tonometer was tilted too far upwards.
The tonometer was probably tilted downwards. Make sure that
the central groove is in the horizontal position.
The probe probably made contact with the eyelid.
The probe made contact with the opening eyelid or
calcification in the cornea.
The probe may have made contact with a peripheral part of the
cornea or the probe was twisted or otherwise inserted
incorrectly. If this error message repeats, remove and replace
the probe.
An erroneous measurement for a reason other than those
described in E01−E07.
DIAGRAM OF TONOMETER FUNCTIONS
Measurement button (measure, confirm)
Selector button (left and right)
TECHNICAL INFORMATION
Type: TA01i.
The device conforms to CE regulations.
Dimensions: 13 – 32 mm (W) * 45 – 80 mm (H) * 230 mm (L).
Weight: 155 g (without batteries), 250 g (4 x AA batteries).
Power supply: 4 x AA non-rechargeable batteries (e.g. alkaline).
Measurement range: 7-50 mmHg, display range: 0-99 mmHg (IOP estimation beyond the measuring range).
Accuracy (95 % tolerance interval relative to manometry): ±1.2 mmHg (≤20 mmHg) and ±2.2 mmHg (>20 mmHg).
Repeatability (coefficient of variation): <8 %.
Accuracy of display: 1.
Display unit: Millimeter mercury (mmHg).
The serial number is on the back of the battery compartment cover.
There are no electrical connections from the tonometer to the patient.
The device has B-type electric shock protection.
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30 % to 90 %
Atmospheric pressure: 800 hPa-1,060 hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 700 hPa-1,060 hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10 % to 95 %
Atmospheric pressure: 500 hPa-1,060 hPa
Mode of operation: continuous.
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Icare tonometer TA01i manual
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PERFORMANCE DATA
The performance data is obtained from a clinical study, performed according to American National Standard ANSI Z80.10-2003 and International Standard
ISO 8612.2 for tonometers. The study was performed ain the Department of Ophthalmology, Helsinki University Central Hospital. In the study, 158
patients were measured. The mean paired difference and standard deviation (Goldmann-Icare) were -0.4 mmHg and 3.4 mmHg. A scattergram and BlandAltman plot of the results is shown below.
ACCESSORIES
SKU
104
102
7210
540
550
560
500
7171
7000
543
561
562
563
564
PRODUCT DESCRIPTION
BOX OF 100 PROBES
BOX OF 100 PROBES (ONLY USA)
PROBE BASE COLLAR
PROBE BASE
TABLE STAND
WRIST STRAP
ALUMINIUM CASE
BATTERY COVER & SCREW
THREAD PLATE
PROBE BASE CLEANING CONTAINER
SILICON GRIP - WHITE
SILICON GRIP - PINK
SILICON GRIP - GREEN
SILICON GRIP - BLUE
WEIGHT
89,10 g
89,10 g
1g
4g
52g
3g
700g
4g
1g
3g
26g
DIMENSIONS
5,3 x 10,3 x 3,6 cm
5,3 x 10,3 x 3,6 cm
11 mm x 10 mm
7 mm x 38 mm
73 mm x 52 mm x 38 mm
270 mm x 10 mm x 10 mm
240 mm x 280 mm x 72 mm
42 mm x 17 mm x 13 mm
4 mm x 10 mm x 3 mm
5,6 cm x 2 cm
135 mm x 46 mm x 23 mm
MAINTENANCE
Follow local regulations and recycling instructions regarding the disposal or recycling of the Icare tonometerand accessories.
WARNING
The tonometer should only be opened by qualified service personnel. It contains no userserviceable parts, apart from the batteries and a probe base. The
Icare tonometerrequires no routine servicing or calibration other than changing the batteries at least every 12 months or changing or cleaning the probe
base. If servicing is necessary, contact qualified service personnel or your local Icare representative.
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Icare tonometer TA01i manual
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Replacing the probe base
Replace the probe base every twelve months. Clean or replace the probe base if the error messages E01 or E03 are displayed.
Instructions for replacing the probe base:
• Turn off the tonometer.
• Unscrew the probe base collar and put it in a safe place.
• Remove the probe base by tilting the tonometer downwards and use your fingers to pull the probe base
out of the tonometer.
• Insert a new probe base into the tonometer.
• Screw the collar in, to lock the probe base.
Cleaning the probe base
You can reuse the probe base after careful cleaning. Clean the probe base every six months. Clean or
replace the probe base if the error messages E01 or E03 are displayed.
Instructions for cleaning the probe base:
• Fill the probe base cleaning container or other clean container with 100% isopropyl alcohol.
• Turn the power off.
• Unscrew the probe base collar.
• Invert the probe base over the container, drop in the probe base into the container and let soak for 5-30 minutes.
• Remove the probe base from alcohol.
• Dry the probe base by blowing clean canned or compressed air into the hole in the probe base. This will additionally remove possible residual dirt.
• Insert the probe base into the tonometer.
• Screw the collar in, to lock the probe base.
Cleaning the tonometer
WARNING
Never spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Dry any liquid on the surface of
the tonometer immediately.
Icare TA01’s surfaces have been tested and found chemically resistant to the following liquids:
• 100 % 2-propanol
• Mild soap solution
• 95% Pursept solution
Cleaning instructions for surfaces:
• Turn the power off.
• Dampen a soft cloth with one of the liquids mentioned above.
• Lightly wipe the surfaces of the tonometer with the soft cloth.
• Dry the surfaces with a dry soft cloth.
Replacing the batteries
Unscrew the battery compartment locking screw with a screwdriver or a small coin.
Remove the battery compartment cover. Remove the old batteries.
Insert a new set of batteries (four AA batteries). Do not use rechargeable batteries, since they may not function properly (the inner resistance of some
rechargeable batteries is too high). Insert the batteries in accordance with the diagrams inside the battery compartment, with the +terminals pointing
downwards on the display side of the tonometer (the rear side), and the -terminals pointing downwards on the measurement side (the front side).
Replace the battery compartment cover and secure it by screwing it in lightly using the coin or screwdriver. Take care not to use excessive force when
screwing the cover into place.
Battery compartment cover
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Returning the Icare tonometer for servicing /repair
Contact Icare Finland’s Technical Services Department (see www.icarefinland.com) or your local Icare representative for shipping instructions. Unless
otherwise instructed by Icare Finland, there is no need to ship accessories along with the tonometer. Use a suitable carton with the appropriate packaging
material to protect the device during shipment. Return the device using any shipping method that includes proof of delivery.
Periodic Safety Checks
We recommend that the following checks be performed every 24 months.
Equipment inspection for mechanical and functional damage.
Inspection of safety labels for legibility.
Applicable in Germany only: Messtechnische Kontrolle nach MPG (Medizinproduktegesetz) alle 24 Monate.
PATENTS AND COPYRIGHTS
US Patent No 6,093,147 and patents pending. The Icare tonometer is also protected by the applicable copyright laws.
SYMBOLS
Attention!!! See instructions
Lot number
Serial number
Manufacturing date
Single use only
Sterilized using radiation
B-type device
Keep dry
Manufacturer
Storage environment
Transport environment
ELECTROMAGNETIC DECLARATION
WARNING
Use of any accessories and cables other than those specified in the manufacturer’s documentation, with the exception of cables sold by the manufacturer
as replacement parts for internal components, may result in increased emissions or decreased immunity of the Icare TA01i tonometer.
WARNING
Use of any accessory or cable with the Icare TA01i tonometer other than those specified may result in increased emissions or decreased immunity of the
Icare TA01i tonometer.
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Icare tonometer TA01i manual
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TA01i is class B equipment and needs special precautions regarding EMC and needs to be installed and put into service according to EMC information
provided in user and maintenance manual.
Guidance and manufacturer’s declaration-Electromagnetic emissions
TA01i is intended for use in the electromagnetic environment specified below. The user of the TA01i should assure that it is used in such an
environment.
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
NOT APPLICABLE
Voltage fluctuations flickering emissions
IEC 61000-3-3
NOT APPLICABLE
Icare TA01i is battery operated and use RF
energy only for its internal function.
Therefore, its RF emissions are low and are
not likely to cause any interference in nearby
equipment.
Icare TA01i is suitable for use in all
establishments, including domestic
establishments and those directly connected
to public low-voltage power supply network
that supplies buildings used for domestic
purposes
Guidance and manufacturer’s declaration-Electromagnetic immunity
Icare TA01i is intended for use in the electromagnetic enviroment specified below. The customers or users of Icare TA01i should assurre
that it is used in such enviroment
Immunity test
IEC 60601 Test level
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Electrical fast
Transients/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruption
and voltage variations on power
supply lines
IEC 61000-4-11
±2 kV for power supply lines
±1 kV for input/output lines
NOT APPLICABLE
±1 kV for line(s) to line(s)
±2 kV for line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
3 A/m
NOT APPLICABLE
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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Electromagnetic environmentGuidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%
NOT APPLICABLE
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
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Icare tonometer TA01i manual
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Guidance and manufacturer’s declaration – electromagnetic immunity
Icare TA01i is intended for use in the electromagnetic environment specified below. The customer or the user of the Icare TA01i should assure
that it is used in such an environment.
Immunity test
Radiated RF IEC
61000-4-3
IEC 60601 test level
Compliance level
3 V/m
80MHz to 2,5 GHz
3V/m
Electromagnetic environment-Guidance
Portable and mobile RF communications equipment should be used
no closer to any part of the IcareTA01i, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
3Vrms
150 kHz to 80 MHz
Conducted RF
IEC 61000-4-6
NOT APPLICABLE
d = 1 2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2 5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey should be less than the compliance level
in each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Icare TA01i
is used exceeds the applicable RF compliance level above, the Icare TA01i should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Icare TA01i.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and Icare TA01i
Icare TA01i is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
IcareTA01i can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and Icare TA01i as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
(W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1,2 √P
d = 1,2 √P
d = 2,3 √P
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.2
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
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