ic100 Instruction Manual

Icare ic100 tonometer manual

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Icare ic100 tonometer manual ENGLISH Safety instructions...1 Intended use...2 Introduction...2 Package contents...3 Parts of the tonometer ...3 Installing or changing the batteries ...3 Turning the tonometer on...3 Loading the probe...3 Probe base light indication...3 Measurement...4 Menu functions...5 MEASURE – Access to measurement...5 HISTORY – Old measurements...5 SOUND – Setting of Tonometer buzzer...5 LIGHT – Setting of Probe base light ...5 LANGUAGE – Language setting...6 INFO – Device information...6 Turning the tonometer off...6 Error and info messages...6 Measurement flow chart...7 Accessories, detachable parts and other supplies...8 Technical information...8 Performance data...8 Maintenance...8 Replacing the probe base...9 Cleaning the tonometer...9 Returning the Icare tonometer for servicing / repair...9 Periodic Safety Checks...9 Symbols...9 Electromagnetic declaration...10 Guidance and manufacturer’s declaration IEC 60601-1-2:2014; Edition 4.0 - Electromagnetic Emissions...11 Guidance and manufacturer’s declaration IEC 60601-1-2:2014; Edition 4.0 - Electromagnetic Immunity...11 Guidance and manufacturer’s declaration IEC 60601-1-2:2014; Edition 4.0 - Electromagnetic Immunity...13

English

ENGLISH TONOMETER Icare® ic100 INSTRUCTION MANUAL The information in this document is subject to change without prior notice. In a conflict situation the English version prevails.

0598 This device complies with: Medical Device Directive 93/42/EEC Canadian Medical Device Regulations RoHS Directive 2011/65/EU Copyright © 2018 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.icaretonometer.com, [email protected]

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 push the tonometer into the eye (the tip of the probe should be 4-8mm, or 5/32 - 5/16 inch, from the eye). WARNING The tonometer should only be opened by qualified service personnel. It contains no user serviceable parts, apart from the batteries and a probe base. The Icare tonometer requires no routine servicing or calibration other than changing the batteries at least every 12 months or changing the probe base. If servicing is necessary, contact qualified service personnel or your local Icare representative.

WARNING Never immerse the Icare tonometer, 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 this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING Use only the original and certified probes made by the manufacturer. The probes are for singleuse (one per testing session) only. Use probes taken only from the intact, original packaging. Re-use of the probe could result in incorrect measurement values, in the breakdown of the probe, cross-contamination of bacteria or viruses, and infection of the eye. Re-use will void all responsibilities and liabilities of the manufacturer concerning the safety and effectiveness of the tonometer. WARNING Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of the Icare ic100 (TA011) tonometer, including cables specified by the manufacturer. Otherwise, degradation of the performance could result. PRECAUTION Read this manual carefully, since it contains important information on using and servicing the tonometer. • Retain this manual for future use. • Do not use anesthetic to numb the eye, because no anesthetic is required when performing measurements and anesthetic can affect the measurement results. 1

Icare ic100 tonometer manual • If you do not use the tonometer, it will switch off automatically after 3 minutes. • 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 if it is broken. • 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, clean the forehead support after each patient with a disinfectant, e.g. an alcohol solution. • The tonometer conforms to EMC requirements (IEC 60601-1-2: 2014), 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.

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• Be sure to dispose of the single-use probes properly (e.g. in a container for disposable needles), because they may contain microorganisms from the patient. • Batteries, packaging materials and probe bases must be disposed of according to local regulations. • No part of the tonometer or probes are made with natural rubber latex. • The measurement method of the Icare ic100 tonometer is based on magnetic induction and therefore an external magnetic field in line with the probe may prevent the measurement. In such case the tonometer will continuously ask to repeat the measurement. Situation can be solved either by removing the source of interference from the vicinity of the device or by performing the measurement in different location with no such interference.

INTENDED USE The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

INTRODUCTION The Icare ic100 tonometer is based on a patented, induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The tonometer uses the rebound method. A small and light single-use probe makes contact with the eye very briefly. The tonometer measures the deceleration of the probe and the rebound time, and calculates the IOP from these parameters. A measurement sequence includes six measurements. The probe moves to the cornea and back during every measurement. As a result, after the six measurements the tonometer calculates the final IOP and stores it in the tonometer’s memory. The Essential Performance of the Icare ic100 (TA011) tonometer is to measure the Intraocular Pressure (IOP) and display the measurement results.

English

PACKAGE CONTENTS

TURNING THE TONOMETER ON

PRECAUTION When you have opened the package, check for any external damage or flaws, particularly for damage to the case. If you suspect that there is something wrong with the tonometer, contact the manufacturer or distributor.

Place the wrist strap around your wrist and secure it. The wrist strap protects the tonometer from dropping onto the floor accidentally.

The package contains: • Icare ic100 tonometer • 4 x AA batteries • 100 single use probes in a box • wrist strap • silicone grip • IOP pad • aluminium case • screw driver • additional probe base collar • probe base cover • spare probe base • quick guide • USB memory stick including instruction manuals • warranty card

PARTS OF THE TONOMETER (Figure 1) 1. Forehead support 2. Probe base 3. Collar 4. Display 5. Forehead support adjusting wheel 6. Navigation buttons 7. Measure button 8. Select button

INSTALLING OR CHANGING THE BATTERIES Unscrew the battery compartment locking screw with a screwdriver. Remove the battery compartment cover. Place the wrist strap into the wrist strap attachment at the end of the tonometer. Insert a new set of four AA batteries. Insert the batteries accordance with Figure 2. Do not use rechargeable batteries. Replace the battery compartment cover and secure it by screwing it in lightly using the screwdriver (Figure 2). Take care not to use excessive force when screwing the cover into place.

To turn the tonometer on press the Select or Measure button. The following figures show two alternative ways of starting the tonometer: Pressing the Select button

MEASURE

Pressing the Measure button

LOAD

LOADING THE PROBE Step 1. Remove the probe base cover (do not dispose of the cover) and open the probe tube by removing the cap and insert the probe into the probe base as shown in Figure 3. Step 2. After loading the probe the tonometer will be ready for measurement when Playsymbol appears on the display (Figure 4).

PROBE BASE LIGHT INDICATION The probe base light serves two purposes. First, it helps guide alignment of the device by showing a red light when the device is in the wrong position (i.e. too much vertical tilt) and a green light when the orientation is correct. Second, it indicates errors (see section Error and Info Messages) in addition to the display during the measurement sequence. When any of these errors occurs, the probe base light flashes red until the error is cleared by pressing the “Measure” button. The probe base light flashes red also when the text REPEAT with the yellow repeat symbol come on the display indicating a measurement sequence with too high deviation.

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Icare ic100 tonometer manual

MEASUREMENT PRECAUTION If you do not use the tonometer, it will switch off automatically after 3 minutes. PRECAUTION No anesthetic is required when performing measurements. *Since local anesthetic may lower the tonometer reading, we recommend that you refrain from using an anesthetic when performing measurements. Step 1. Ask the patient to relax and look straight ahead at a specific point. Bring the tonometer near the patient’s eye. Correct head and eye position (Figure 5). Incorrect head and eye position (Figure 6 and 7). Step 2. The device should be in a horizontal position. Keep the probe horizontal and pointing perpendicularly to the center of the cornea. The distance from the tip of the probe to the patient’s cornea (Figure 8) should be 4-8 mm (5/32 - 5/16 inch). If necessary, adjust the distance by turning the forehead support adjusting wheel. Correct alignment of the tonometer and green probe base light indication (Figure 9). If probe base light indication is set OFF green arrows will indicate the correct alignment of the tonometer (Figure 10). Incorrect alignment of the tonometer and red probe base light indication (Figure 11). If probe base light indication is set OFF red arrows will indicate the incorrect alignment of the tonometer (Figure 12).

every successful measurement. After each successful measurement, you will hear a short beep. Series mode: Keep the Measure button down to obtain the sequence of six measurements, blue segments will be lit after every successful measurement. To obtain the final reading, six measurements are required. The measurement values displayed before the final result are average values for all previous measurements (1.-5.). Single measurement values are not shown.

TOO NEAR

If there is an erroneous measurement, the tonometer will beep twice and display an error message. Press the Measure button to clear the error message. If several erroneous measurements appear, see error messages. Step 4. Once the six measurements have been performed, you will hear a long beep. The final IOP will be shown on the display rounded by green (perfect, Figure 14) or yellow (some variation, Figure 15) segments. If variation is too big. Repeat will be displayed.

REPEAT

The displayed result is an average of four measurements as the highest and the lowest reading are discarded before the average calculation.

Step 3. You may perform the measurement in single or series mode (Figure 13).

The colors green and yellow as well as repeat indication are related to the standard deviation (SD) of the probe’s motion parameters of the four remaining measurements.

Single mode: Press the Measure 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 should be made consecutively, blue segments will be lit after

Step 5. Following the performance of the entire measurement, a new measurement series can be begun by pressing the Measure button. The tonometer will then reactivate the probe and be ready for the next measurement series with the Play symbol on the display (Figure 16).

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English The measurement sequence can be aborted by pressing the Select button. Place the probe base cover back to cover the probe base when the tonometer is not in use. 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.), it is recommended that he/she repeat the measurement. In addition, when

encountering unusual values (for example, very high or very low values) it is recommended that a repeat measurement be taken either with the Icare tonometer or an alternative method to verify the result. *Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure. Ophthalmologica 1994;208:309-313.

MENU FUNCTIONS (Figure 17) Scrolling between the Menu functions starts from the MEASURE display, press either of the Navigation buttons located around the Select button. Menu functions are MEASURE, HISTORY, SOUND, LIGHT, LANGUAGE and INFO MEASURE – Access to measurement MEASURE

Press the Select button to access. If the probe is not loaded the LOAD display appears. Tonometer is ready for measurement when Play-symbol display appears. To exit, press the Select button.

LOAD

HISTORY – Old measurements

Press the Select button to access. Scroll through the old values by pressing either of the Navigation buttons. Value colors green and yellow are related to Standard deviation (SD). To exit, press the Select button.

HISTORY

SOUND – Setting of Tonometer buzzer SOUND ON

ON

OFF

Blue text and symbol is active setting. Press the Select button to access. Turn the sound ON and OFF by pressing either of the Navigation buttons. To accept selection, press the Select button. LIGHT – Setting of Probe base light

LIGHT ON

ON

OFF

Blue text and symbol is active setting. Press the Select button to access. Turn the light ON and OFF by pressing either of the Navigation buttons. To accept selection, press the Select button.

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Icare ic100 tonometer manual

LANGUAGE – Language setting SVENSKA

DEUTCH

LANGUAGE ENGLISH

Blue text is active setting. Press the Select button to access. Scroll through the language options by pressing either of the Navigation buttons. To accept selection, press the Select button. INFO – Device information

Press the Select button to access. Serial number (SN) of the tonometer. Software version (SW) of the tonometer. To exit, press the Select button

INFO

TURNING THE TONOMETER OFF Press the Select button (Figure 18) until the display shows the End-symbol (Figure 19). If you do not use the tonometer, it will switch off automatically after 3 minutes.

ERROR AND INFO MESSAGES The following messages may appear on the display: MESSAGE

DESCRIPTION

ACTIONS

Battery charge is low.

Prepare to replace the batteries.

The batteries are empty.

Turn the tonometer OFF by pressing Select button. Replace the batteries.

The probe did not move.

Change the probe. The probe was twisted or otherwise inserted incorrectly. To clear error messages, press the Measure button, after which the measurement can be repeated.

The probe did not move properly for several times during the measurement sequence.

Replace the probe base as instructed in Replacing the probe base. To clear error messages, press the Measure button, after which the measurement can be repeated.

CHANGE

CHANGE

CLEAN CHANGE

The probe did not touch the eye. Adjust correct measurement distance 4-8 mm. The measurement was taken from too far away. TOO FAR

Too short measurement distance between the probe and the cornea. TOO NEAR

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Adjust correct measurement distance 4-8 mm. The measurement was taken from too close. To clear error messages, press the Measure button, after which the measurement can be repeated.

English

REPEAT

The probe did not move properly. The probe did not make clean contact with the cornea, because the probe hit an eyelid or eyelashes. Internal error detected.

SERVICE

Ensure that the eye is open, measure again. To clear error messages, press the Measure button, after which the measurement can be repeated. Turn the tonometer OFF by pressing Select button. Contact the seller to arrange sending the device for service.

MEASUREMENT FLOW CHART Turn Tonometer ON by pressing Select or Measure button

This is displayed if you pressed the Select button, pressing of Measure button would lead you directly to Load Probe MEASURE

Load Probe

LOAD

Ready to measure

Measure 6 times by pressing Measure button (blue color bar shows the progress)

Successful measurement

Repeat the measurement

REPEAT

Tonometer OFF by pressing Select button >3 seconds 7

Icare ic100 tonometer manual

ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES SKU 104 7217 7218 540 559 525 7169 623 565 548 577 544

PRODUCT DESCRIPTION PROBE ICARE TP01, 100 pcs/box TA011/TV011 collar TA011/TV011 collar narrow Probe base Wrist strap with lock Aluminium case, Icare ic100 Battery cover & screw, Icare ic100 IOP pad, Icare ic100 Silicone grip - white, Icare ic100 Screw driver, Icare USB memory stick Probe base cover

TECHNICAL INFORMATION Type: TA011 Dimensions: 24 - 29 mm (W) * 35 - 95 mm (H) * 215 mm (L). Weight: 140 g (without batteries), 230 g (4 x AA batteries). Power supply: 4 x AA non-rechargeable batteries, 1.5 V alkaline LR6. Measurement range: 7-50 mmHg Accuracy: ±1.2 mmHg (≤20 mmHg) and ±2.2 mmHg (>20 mmHg). Repeatability (coefficient of variation): <8 %. Accuracy of display: 1 mmHg. Display unit: Millimeter of mercury (mmHg). The serial number is on the inside of the battery compartment cover. There are no electrical connections from the tonometer to the patient. The device has BF-type electric shock protection. The single use probe and the forehead support of the device are considered as applied parts. 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 8

WEIGHT 89 g 4g 1g 4g 4g 800 g 6g 38 g 26 g 15 g 44 g 1g

DIMENSIONS 53 x 109 x 36 mm 18 x 18 mm 17 x 18 mm 7 x 38 mm 10 x 10 x 270 mm 240 x 280 x 72 mm 110 x 25 x 12 mm 50 x 53 x 16 mm 45 x 35 x 113 mm 16 x 90 mm 98 x 11 x 93 mm 19 x 11 mm

Relative humidity: 10 % to 95 % Atmospheric pressure: 500 hPa-1,060 hPa Mode of operation: continuous

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 for tonometers. The study was performed in the Department of Ophthalmology, Helsinki University Central Hospital. In the study, 158 patients were measured. The mean paired difference and standard deviation (GoldmannIcare) were -0.4 mmHg and 3.4 mmHg. A scattergram and Bland-Altman plot of the results is shown in Figure 20.

MAINTENANCE Follow local regulations and recycling instructions regarding the disposal or recycling of the Icare tonometer and accessories. WARNING The tonometer should only be opened by qualified service personnel. It contains no user serviceable parts, apart from the batteries and a probe base. The Icare tonometer requires no routine servicing or calibration other than changing the batteries at least every 12 months or changing the probe base. If servicing is necessary, contact qualified service personnel or your local Icare representative.

English

REPLACING THE PROBE BASE

PERIODIC SAFETY CHECKS

(Figure 21) Replace the probe base every six months. Replace the probe base if the error message Clean Change is displayed.

We recommend that the following checks be performed every 24 months. Equipment inspection for mechanical and functional damage. Inspection of safety labels for legibility.

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.

Applicable in Germany only: Messtechnische Kontrolle nach MPG (Medizinproduktegesetz) alle 24 Monate.

SYMBOLS Attention!!! See instructions See operating instructions for more information

CLEANING THE TONOMETER WARNING Never immerse the Icare tonometer, 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 ic100’s surfaces have been tested and found chemically resistant to the following liquids: • 70-100 % isopropyl alcohol • 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.

RETURNING THE ICARE TONOMETER FOR SERVICING / REPAIR Contact Icare Finland’s Technical Services Department (see www.icaretonometer.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.

SN

Serial number Single use only BF-type device

Rx Only

LOT

Federal law (U.S.) restricts this device to sale by or on the order of a physician. Lot number Manufacturing date Keep dry Manufacturer Do not discard this product with other household-type waste. Send to appropriate facility for recovery and recycling. EU WEEE (European Union Directive for Waste of Electronic and Electrical Equipment)

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Icare ic100 tonometer manual

95%

55°C -10°C

10%

Temperature limits

Storage environment

700hPa

95%

70°C -40°C

1060hPa

10%

1060hPa

500hPa

Humidity limits

Transport environment

Atmospheric pressure limits

ELECTROMAGNETIC DECLARATION WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

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WARNING Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of the Icare ic100 (TA011) tonometer, including cables specified by the manufacturer. Otherwise, degradation of the performance could result. The Icare ic100 (TA011) tonometer is a class B equipment and needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in Instruction for use manual. Portable and mobile RF communications equipment can affect the Icare ic100 (TA011) Tonometer.

English

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC EMISSIONS

Icare ic100 (TA011) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic100 Tonometer (TA011) should assure that it is used in such an environment. RF emissions CISPR 11 Group 1 Icare ic100 (TA011) is battery operated and uses RF energy only for its internal function. Therefore, its RF emissions are low and are not likely to cause any interference in nearby equipment RF emissions CISPR 11 Class B Icare ic100 (TA011) 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 Harmonic emissions Not applicable Not applicable IEC 61000-3-2 Voltage fluctuations flickering emissions IEC 61000-3-3

Not applicable

Not applicable

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare ic100 (TA011) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic100 Tonometer (TA011) should assure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Electrostatic discharge ± 8 kV contact ± 8 kV contact Floors should be wood, concrete or (ESD) IEC 61000-4-2 ± 2 kV, ±4 kV, ± 15 kV air ceramic tile. If floors are covered ±8 kV, ±15 kV air with synthetic material, the relative humidity should be at least 30 % Electrical fast ± 2 kV 100 kHz Not applicable Not applicable Transients / burst repetition IEC 61000-4-4 frequency Surge IEC 61000-4-5

±1 kV for line(s) to Not applicable line(s) ±2 kV for line(s) to earth

Not applicable

Voltage dips, short interruption and voltage variations on power supply lines IEC 61000-4-11

0 % UT for Not applicable 0.5 cycle (1 phase) 0 % UT for 1 cycle 70 % UT for 25/30 cycles (50/60 Hz) 0 % UT for 250/300 cycles (50/60 Hz)

Not applicable

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Icare ic100 tonometer manual

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare ic100 (TA011) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic100 Tonometer (TA011) should assure that it is used in such an environment. Power frequency 30 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) magnetic should be at levels characteristic field IEC 61000-4-8 of a typical location in a typical commercial or hospital environment. WARNING: Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of Icare ic100 (TA011), including cables specified by the manufacturer. Otherwise, degradation of the performance could result.

Conducted disturbances induced by RF fields IEC 61000-4-6

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3V Not Applicable 0,15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

The measurement method of the Icare ic100 tonometer is based on magnetic induction and therefore an external magnetic field in line with the probe may prevent the measurement. In such case the tonometer will continuously ask to repeat the measurement. Situation can be solved either by removing the source of interference from the vicinity of the device or by performing the measurement in different location with no such interference. Not Applicable

English

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare ic100 (TA011) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic100 Tonometer (TA011) should assure that it is used in such an environment. Radiated RF 3 V/m 3 V/m WARNING: Portable RF IEC 61000-4-3 80 MHz – 2,7 GHz communications equipment 80% AM at 1 kHz (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Icare ic100 (TA011) including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Interference may occur in the vicinity of equipment marked with the following symbol:

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY

Icare ic100 (TA011) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic100 Tonometer (TA011) should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Proximity fields 380 - 390 MHz 27 V/ m; 27 V/m WARNING: Portable RF from RF wireless PM 50%; 18 Hz communications equipment communications (including peripherals such as equipment 430 - 470 MHz 28 V/m; 28 V/m antenna cables and external IEC 61000-4-3 (FM ±5 kHz, 1 kHz sine) antennas) should be used no PM; 18 Hz closer than 30 cm (12 inches) to any part of the Icare ic100 704 - 787 MHz 9 V/m; 9 V/m (TA011) including cables specified PM 50%; 217 Hz by the manufacturer. Otherwise, degradation of the performance 800 - 960 MHz 28 V/m; 28 V/m of this equipment could result. PM 50%; 18 Hz Interference may occur in the 1700 - 1990 MHz 28 V/m; 28 V/m vicinity of equipment marked PM 50%; 217 Hz with the following symbol: 2400 - 2570 MHz 28 V/m; PM 50%; 217 Hz

28 V/m

5100 - 5800 MHz 9 V/ m; PM 50%; 217 Hz

9 V/m

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