Icare TAO1i Instruction Manual ver 2.0

Icare TA01i tonometer manual

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Icare TA01i tonometer manual ENGLISH INDICATIONS FOR USE...1 INTRODUCTION...1 SAFETY INSTRUCTIONS...1 PARTS OF THE TONOMETER...2 TURNING THE TONOMETER ON AND LOADING THE PROBE...2 Load the probe in the following way:...3 MEASUREMENT...3 DISPLAY AFTER MEASUREMENTS...3 OTHER FUNCTIONS...4 Accessing old measurement value...4 Turning the tonometer OFF...4 Error messages...4 DIAGRAM OF TONOMETER FUNCTIONS...5 TECHNICAL INFORMATION...5 PERFORMANCE DATA...5 ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES...5 MAINTENANCE...5 Replacing the probe base...6 Cleaning the tonometer...6 Replacing the batteries...6 Returning the Icare tonometer for servicing /repair...6 Periodic Safety Checks...6 PATENTS AND COPYRIGHTS...6 SYMBOLS...7 ELECTROMAGNETIC DECLARATION...7

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ENGLISH TONOMETER Icare® TA01i INSTRUCTION MANUAL The information in this document is subject to change without prior notice. In a conflict situation the English version prevails.

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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]

INDICATIONS FOR USE The Icare TA01i tonometer 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. The Essential Performance of the Icare TA01i tonometer is to measure the Intraocular Pressure (IOP) and display the measurement results.

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 5/32 - 5/16inch, 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 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.

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Icare TA01i tonometer manual

WARNING Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of the Icare TA01i tonometer, including cables specified by the manufacturer. Otherwise, degradation of the performance could result. WARNING In the event of battery short circuit, the batteries and the device handle could get hot and there is a possible risk of a burn if touched. PRECAUTION • 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. 2

• 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. • 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. • The measurement method of the Icare TA01i 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.

PARTS OF THE TONOMETER (Figure 1) 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 (See chapter: Replacing the batteries).

English Press the measurement button to turn the tonometer ON. The tonometer will turn ON and OFF all the segments of the LCD display for three times. Check that all of the segments are functional in the four-digit, seven-segment LCD display (Figure 2). 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 measurement 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 (Figure 3 and 4). 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 (Figure 5).

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 probe to the patient’s cornea (see picture) should be 4-8 mm (5/32 - 5/16inch) (Figure 6). 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 (See chapter: Error messages). 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 figure 7). 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 22 mmHg 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 00

After the second measurement 2. 13

After the sixth measurement 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. 3

Icare TA01i tonometer manual 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 measurement should be repeated. This symbol occurs also in case of electromagnetic fields disturbing the measurement.

OTHER FUNCTIONS ACCESSING OLD MEASUREMENT VALUE

(Figures 7-9) 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

(Figures 10-12) 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: MESSAGE bAtt E 01

E 02 E 03 E 04 E 05 E 06 E 07

E 09 4

STATE The batteries are low. The probe did not move at all.

DESCRIPTION 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 a new one (see figure 15). The probe did not touch The measurement was taken from too far away. the eye. The probe speed was The measurement was taken from too far away or the too low. tonometer was tilted too far upwards. The probe speed was The tonometer was probably tilted downwards. Make sure too high. that the central groove is in the horizontal position. The contact with the eye The probe probably made contact with the eyelid. was too “soft.” The contact with the eye The probe made contact with the opening eyelid or was too “hard.” calcification in the cornea. The probe measurement The probe may have made contact with a peripheral part of signal detected by the the cornea or the probe was twisted or otherwise inserted tonometer was unusual. incorrectly. If this error message repeats, remove and replace the probe. Bad data. An erroneous measurement for a reason other than those described in E01−E07.

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DIAGRAM OF TONOMETER FUNCTIONS (Figure 13) 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. 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 • 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 14.

ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES SKU 104 7210 540 550 560 500 7171 7000 561 562 563 564

PRODUCT DESCRIPTION PROBE ICARE TP01, 100 pcs/box PROBE BASE COLLAR PROBE BASE TABLE STAND WRIST STRAP ALUMINIUM CASE BATTERY COVER & SCREW THREAD PLATE SILICON GRIP - WHITE SILICON GRIP - PINK SILICON GRIP - GREEN SILICON GRIP - BLUE

MAINTENANCE Follow local regulations and recycling instructions regarding the disposal or recycling of the Icare tonometer and accessories.

WEIGHT 89,10 g 1g 4g 52 g 3g 700 g 4g 1g 26 g

DIMENSIONS 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 135 mm x 46 mm x 23 mm

WARNING The tonometer should only be opened by qualified service personnel. It contains no user serviceable parts, apart from the batteries and 5

Icare TA01i tonometer manual 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. REPLACING THE PROBE BASE

Replace the probe base every six months. 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 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: • 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. REPLACING THE BATTERIES

(Figure 16) Unscrew the battery compartment locking screw with a screwdriver or a small coin. Remove the battery compartment cover. Remove the old batteries.

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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 (Figure 17). 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. 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 The Icare tonometer is patented and protected by the applicable copyright laws.

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SYMBOLS Manufacturing date

Attention!!! See instructions SN

Serial number

Keep dry

Single use only

Rx Only

B-type device

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)

Manufacturer LOT

Lot number

95%

55°C -10°C

10%

-40°C

Temperature limits

1060hPa

Storage environment

700hPa

95%

70°C

Federal law (U.S.) restricts this device to sale by or on the order of a physician.

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 Sources of power frequency magnetic field should be used no closer than 15 cm (6 inches) to any part of the Icare TA01i tonometer, including cables specified by the manufacturer. Otherwise, degradation of the performance could result.

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. 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. Portable and mobile RF communications equipment can affect the Icare TA01i tonometer.

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Icare TA01i tonometer manual

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

Icare TA01i is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare TA01i Tonometer should assure that it is used in such an environment. RF emissions CISPR 11 Group 1 Icare TA01i s 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 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 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 TA01i is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare TA01i Tonometer should assure that it is used in such an environment. Immunity test

IEC 60601 test level Electrostatic discharge ± 8 kV contact (ESD) IEC 61000-4-2 ± 2 kV, ±4 kV, ±8 kV, ±15 kV air

Compliance level ± 8 kV contact ± 15 kV air

Electrical fast Transients / burst IEC 61000-4-4

± 2 kV 100 kHz repetition frequency

Not applicable

Surge IEC 61000-4-5

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

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

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Electromagnetic environment guidance 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

Not applicable

Not applicable

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GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare TA01i is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare TA01i Tonometer should assure that it is used in such an environment. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

30 A/m

Power frequency magnetic fields should be at levels characteristic 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 TA01i, including cables specified by the manufacturer. Otherwise, degradation of the performance could result.

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

3V Not Applicable 0,15 MHz – 80 MHz

The measurement method of the Icare TA01i 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 and display error codes. The final result is accompanied with blinking P (line up) symbol to indicate that the measurement shall be repeated. 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

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

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Icare TA01i tonometer manual

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC IMMUNITY Icare TA01i is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare TA01i Tonometer should assure that it is used in such an environment. Radiated RF IEC 61000-4-3

3 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz

3 V/m

WARNING: Portable RF communications equipment (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 TA01i 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 TA01i is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare TA01i Tonometer 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 TA01i 704 - 787 MHz 9 V/m; 9 V/m including cables specified by PM 50 %; 217 Hz 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:

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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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