ICARE

ic200 Instruction Manual Ver 2.8

Instruction Manual

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File Name: ICARE - TA031-046 EN - ic200 Instruction Manual Ver 2.8.pdf

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INSTRUCTION MANUAL ENGLISH

Icare ic200 tonometer manual

ENGLISH

TONOMETER Icare® ic200 INSTRUCTION MANUAL TA031-046 EN 2.8 The information in this document is subject to change without prior notice. Should a conflict situation arise concerning a translated document, the Englishlanguage version shall prevail.

0598 This device complies with: Medical Device Directive 93/42/EEC Canadian Medical Device Regulations RoHS Directive 2011/65/EU Radio equipment directive 2014/53/EU. Copyright © 2019 Icare Finland Oy. All rights reserved. Icare is a registered trademark of Icare Finland Oy, all other trademarks are the property of their respective owners. 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]

TABLE OF CONTENTS SAFETY INSTRUCTIONS... 3 INTENDED USE... 5 INTRODUCTION... 5 PACKAGE CONTENTS... 5 FEATURES AND PARTS OF THE TONOMETER...5 TAKING THE DEVICE INTO USE... 6 INSTALLING THE WRIST STRAP...6 INSTALLING THE BATTERIES FOR THE FIRST TIME...6 TURNING THE TONOMETER ON...7 LOADING THE PROBE ... 7 PROBE BASE INDICATOR LIGHT ... 7 MEASUREMENT... 8 USER INTERFACE FUNCTIONS... 11 BLUETOOTH ... 12 PRINTER ...12 EXPORT...13 ERROR AND INFO MESSAGES ... 14 MEASUREMENT FLOW CHART... 15 ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES...16 TECHNICAL INFORMATION... 16 IT-NETWORK SPECIFICATIONS...16 PERFORMANCE DATA... 17 MAINTENANCE... 17 REPLACING THE PROBE BASE... 17 CLEANING THE TONOMETER... 17 RETURNING THE ICARE TONOMETER FOR SERVICING OR REPAIR...18 PERIODIC SAFETY CHECKS... 18 SYMBOLS... 18 INFORMATION TO THE USER REGARDING THE RADIO COMMUNICATION PART OF THE DEVICE...19 ELECTROMAGNETIC DECLARATION...20

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Icare ic200 tonometer manual

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SAFETY INSTRUCTIONS WARNING The tonometer device must not come into contact with the patient’s eyes. When adjusting the forehead resting support for the tonometer, do not accidentally push the tonometer or probe into the eye. The tonometer’s forehead spacing support needs to be adjusted to maintain the tip of the probe about 5 mm, or about 3/16 inch, from the eye. During measurement, only the probe makes contact with eye, for a fraction of a second. 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 and changing the probe base. If there is reason to believe servicing of the device is necessary, contact qualified service personnel or your local Icare representative. WARNING Changes or modifications not expressly approved by Icare Finland Oy could void the user’s authority to operate the equipment. WARNING Never immerse the Icare tonometer in liquid. Do not spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Remove any liquid appearing on the surface of the tonometer immediately. WARNING Use of this equipment adjacent to, or stacked with, other equipment may result in improper operation and should be avoided. 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, certified probes supplied by the manufacturer. The probes are for single-use (one per measurement session) only. Each testing session is defined by one successful measurement in both eyes, but in case either eye is inflamed or infected the healthy eye should be measured first. Use probes taken only from the intact, original packaging. Re-use of a probe could result in incorrect measurement values, damage to the probe, cross-contamination by bacteria or viruses or infection of the eye. Re-use of probes voids all responsibilities and liabilities of the manufacturer concerning the safety and effectiveness of the tonometer. WARNING Federal law (U.S.) restricts this device to sale by or on the order of a physician. WARNING To prevent contamination, keep unused probes in their box, do not touch the bare probe, do not use a probe if it touches a non-sterile surface like a table or a floor. Do not use the touched or dropped probe, dispose of it properly (e.g. in containers for disposable needles). WARNING Connection of the ic200 tonometer to IT networks including other equipment could result in previously unidentified risks to patients, operators, or third parties. WARNING The responsible organization should identify, analyze, evaluate, and control any additional risks resulting from the ic200 tonometer connected to IT networks including other equipment. WARNING Removing, covering or defacing any label or sign of the device voids all responsibilities and liabilities of the manufacturer concerning the safety and effectiveness of the tonometer. PRECAUTION Read this manual carefully, since it contains important information on using and servicing the tonometer. Do not use any anesthetic to numb the eye, an anesthetic can affect the measurement results. No anesthetic is required when performing measurements with this device. If the tonometer is not used for 3 minutes, it will automatically switch itself off (the probe may then fall out). After removing the device from its packaging, visually inspect the tonometer for any external damage, particularly for possible damage to the device casing. If you suspect damage to the tonometer, contact the manufacturer or distributor. Use the tonometer only for measuring intraocular pressure, any other use is improper. The manufacturer cannot be held liable for any damage arising from improper use of the tonometer, or any consequences thereof.

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Icare ic200 tonometer manual

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Never open the casing of the tonometer, except for battery replacement or changing the probe base. This manual contains instructions for replacing batteries and changing the probe base. Keep the tonometer out of reach of children. The probe base, battery compartment cover, screws, collar and probes are small objects and may be accidentally swallowed. Do not use the device if it appears to be damaged or malfunctioning. The device must be delivered to service for repair. Do not use the device near inflammable substances, including inflammable anesthetic agents. Prior to each new patient to be measured, check that a new disposable probe from an intact package is being used. After inserting the probe in the probe base, visually inspect the probe to ensure that the small plastic round tip is visible at the front. Do not use a probe without the plastic tip. The tonometer conforms to EMC requirements (IEC 60101-1-2), performance of the tonometer may be affected if it is used near to (<1 m) another electrical device, such as a cellular phone, emitting high-intensity electromagnetic radiation. The tonometer’s own electromagnetic emissions are well below the maximum levels permitted by the relevant standards. Nevertheless, the tonometer may cause interference in the operation of highly sensitive devices in the immediate vicinity. If the device is not intended to be used for a long period of time, it is recommended to remove the batteries from the battery compartment. Removing the batteries will not affect the subsequent functioning of the tonometer. Used probes cannot be recycled. Dispose of used probes properly (e.g. in containers for disposable needles or in a bin for metal waste). Batteries, packaging materials and probe bases must be disposed of according to local regulations. To avoid dropping of the device and to ensure the safe handling of the device, always use the wrist strap to keep the device attached to the wrist when in use. Use only the types of battery specified in the Technical Information section of this instruction manual. The measurement method of the Icare ic200 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. Changes to the IT network could introduce new risks requiring additional analysis by the responsible organization. The changes include: • changes in the IT-network configuration • connection of additional items to the IT-network • disconnecting items from the IT-network • update or upgrade of equipment connected to the IT-network

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Icare ic200 tonometer manual

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INTENDED USE The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

INTRODUCTION The Icare ic200 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 Icare ic200 tonometer allows for a patient’s IOP to be measured for patients in the supine position as well as in upright (sitting or standing) positions. With the Icare rebound measurement method, a miniature, light-weight probe is launched in a direction perpendicular to the surface of the center of the cornea of the eye. The probe is composed of a medical grade plastic tip and a metal shaft. The metal shaft is magnetized prior to measurement. During a measurement, the probe can be considered to act like a moving magnet that induces an electric signal in the surrounding coil allowing for highly accurate measurement of the probe’s motion. After launching, the probe briefly makes contact with the cornea and bounces back. The tonometer records multiple parameters covering the motion of the probe, including deceleration and rebound time. Using a proprietary algorithm, the device is able to calculate the eye’s IOP. A displayed IOP reading is derived from the results from a sequence of six individual IOP measurements and calculations, made each of the six times the probe hits the cornea and rebounds. The displayed IOP measurement is also stored in the tonometer’s memory for later retrieval. The Icare ic200 tonometer incorporates a Bluetooth® module which allows wireless connectivity to Bluetooth-supported printers or for data transfer. No part of the tonometer or probes contain natural rubber latex.

PACKAGE CONTENTS PRECAUTION When removing the device from its packaging, visually inspect the tonometer for any external damage, particularly for possible damage to the device casing. If you suspect damage to the tonometer, contact the manufacturer or distributor of the device. The Icare ic200 package contains: • Icare ic200 tonometer • 4 x AA 1.5 V batteries • Box of 100 probes • wrist strap • silicone grip

• IOP pad for writing down results • aluminum case • screwdriver • probe base cover • spare probe base

• printed quick guide • USB drive including instruction manuals • printed instruction manuals (EU only) • warranty card

FEATURES AND PARTS OF THE TONOMETER 1. Forehead support 2. Probe base 3. Locking collar 4. Display screen 5. Adjustment wheel for forehead support 6. User interface Navigation buttons 7. Select button 8. Measure button

1. 5. 2.

3. 7. 8.

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Icare ic200 tonometer manual

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TAKING THE DEVICE INTO USE Before using the Icare ic200 tonometer for the first time, attach the wrist strap and insert the batteries.

INSTALLING THE WRIST STRAP Thread the string loop at the end of the wrist strap through the two holes at the bottom of the device (see figure below). Take hold of the end of the wrist strap, turn it back and bring it through the loop. Finally, pull the wrist strap to tighten the loop.

PRECAUTION To avoid dropping the device and to ensure the safe handling of the device, always keep the tonometer attached to the wrist using the wrist strap when operating the device.

INSTALLING THE BATTERIES FOR THE FIRST TIME Unscrew the battery compartment locking screw with the screwdriver supplied. Remove the battery compartment cover. Insert a new set of four AA 1.5 V batteries (LR6). Insert the batteries according to the figure below. Take care to observe correct polarity. Replace the battery compartment cover. Secure the cover in place by tightening the locking screw. Take care not to use excessive force (torque) when tightening the screw. For a maximum grip in hand and traction on a slippery surface you may now install the silicone grip. Put it first over the end of the device and then slide it with a firm grip all the way (rolling and finally unrolling the end of the silicone grip may help). Uninstall the silicone grip in reverse order. PRECAUTION Use only the battery type which is specified in technical specification section of this instruction manual.

3. 4.

1. 2.

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Date: 11.14.2017 Author: Tomi Lonka (Desigence)

Icare ic200 tonometer manual ENGLISH nt name: GUI Flowchart TA031 Document name: GUI Flowchart Document name:TA031 GUI Flowchart TA031 0.1 GUI Flowchart TA031 1.0 nt number: TA031-GUI Document number: TA031-GUI Document number: TA031-GUI er: TA031-GUI : 04 Revision: 04 Revision: 04 .14.2017 Date: 11.14.2017 Date: 11.14.2017 MEASURE Tomi Lonka (Desigence) Author: Tomi Lonka (Desigence) TURNING THE TONOMETER ON Author: Tomi Lonka (Desigence) ka (Desigence) The tonometer can be activated in one of two ways. Either press the Select or the Measure button once. The following figure sequences illustrate the two alternative ways of starting the tonometer:

Document name: GUI Flowchart TA031 0.1 1.0 0.1 0.2 Document number: TA031-GUI 1.0 16/03/2017 Revision: 04 16:36:10 Date: 11.14.2017 MEASURE Author: Tomi Lonka (Desigence) MEASURE

After pressing the Select button 0.3 1.1 0.2

0.1 0.2

1.1

1.2

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16/03/2017

16:36:10

16:36:10 LOAD

LOAD

1.2 1.3

1.1

1.0

1.1

ID 9

EYE

MEASURE OS OD LOAD OS EYE 1.1 1.2 1.4

1.0

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1.2 1.5

ID 9

OD OS OS OD OS MEASURE OD OS OD LOAD LOAD LOAD EYE LOAD EYE EYE EYE

LOAD

OD LOAD

MEASURE

OD OD OS LOAD EYE EY EY

After pressing the Measure button

1.1 1.2 0.3 1.4 1.3 1.5 1.3 1.6 1.4 1.5 1.4 1.3 1.6 1.5 0.2 ID 91.4 ID1.5 IDare 91.6 The device during0.3 the start-up sequence. If9eitherID the9 time and/or date and/or in ID 9 9 as instructed 1.8 1.7correct timeID 1.3 displays the time and date IDincorrect, 9 ID 9set the 9 IDdate ID 9 ID 9 ID 9 ID 9manual. ID 9 the User Interface Functions section of this instruction

16/03/2017

16:36:10 OD OS OD OS OS OS OD OD ODOS OS OS ODOS OS OD OD OD OD OD OS LOAD You may choose measurement. ID may help belongs to whichLOAD patient ODto assign an OSID number OD OS TheEYE OD OS EYEwhich measurement OD OS EYE EYE to any EYEto verify afterwards EYE EYE in the device’s EYE EY EYE EYE measurement History. to the Measure view from the Load view unless you were already EYEPress the Select button to getEYE EYE in the Measure view. Press the right EYE

PATIENT ID

Navigation button two times to get to the Patient ID view, press the Select button again and select a number by the Navigation buttons. Press the Select button to get back, press the left Navigation button two times to get to the Measure view and finally press the Select button to get to the Load view. 0.3 1.4 1.3 1.5 1.6 1.7 1.7 ID 9 1.8 ID 99 ID 9 1.8 1.7 1.8 ID1.8 9 ID 9 ID 1.7 ID1.9 9 ID 9 ID 9 ID 9 ID 9

LOADING THE PROBE

ID 9

Remove the yellow protective cover from the probe base by pulling (not by turning as turning may unscrew the locking collar). Retain the probe base cover (do not discard). OD The probes OSare supplied OD in protective probe tubes. Take a new probe tube and hold the tube with its cap upright. Remove EYE the protective cap. Insert the probe into the tonometer’s probe base by carefully turning the probe tube upside-down, allowing the probe to slide into the probe base (see figure). The tonometer will magnetize the probe and hold it in the probe base. 1.7 A probe can be loaded into the Icare ic200 tonometer even if the device 1.9 has not yet been turned ID 9 on. In this case, the tonometer recognizes that a probe 1.9has been inserted when entering the ID 9 measurement sequence and automatically displays the eye side selection menu.

EYE

23.9 23.9

PROBE BASE INDICATOR LIGHT

The probe base indicator can emit either red or green light when the tonometer is on. The probe OD mmHg base indicator light serves two purposes: Firstly, the indicatorOD helps guide alignment of the mmHg tonometer and probe device by emitting a red light – if the device is too tilted to far up – or a green light when the orientation of the device is acceptable. 1.11 Secondly, the indicator light color changing to red can communicate an error situation ID 9 during the 1.11 on the device’s ID 9 display screen (see section: measurement sequence, in addition to messages shown Error and Info Messages).

20.8 20.8

OD mmHg

1.12

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1.12

ID1.9 9

ID 9

1.8

1.10

ID 9

1.9

ID 9

OD mmHg

1.10

ID 9

1.9

23.9 17.6

1.11

ID 9

1.10

20.8 23.9

1.11

ID 9

1.13

ID 9

OD mmHg

20.8 23.9 ID 9

OD mmHg 1.12

ID 9

1.11

16.5 20.8

ID 9

OD mmHg

OD mmHg 1.13

ID 9

1.12

17 .6 16 16.5.6 ID 9

OD mmHg mmHg ODOD mmHg

OD mmHg ID 9

BAC 2/10

OD mmHg

OD mmHg OD mmHg 1.14 1.13

BACK 2/100

ID 9

OD mmHg

ID 9

23.9 17.6 ID 9

1.10

ID 9

1.12

ID 9

1.11

OD mmHg

2.4

OD mmHg

ID 9

OD mmHg

.5 16.5 16.516.6 16.6 16 20.8

OD mmHg

1.13

OS EYEOD mmHg

17.6

OD mmHg

ID 9

17.6

2.4

17.6 17.6

OD mmHg WARNING ODuse mmHg To prevent contamination, do not touch the bare probe, do not a probe if it touches a non-sterile surface like a table or a floor. Do not use the touched or dropped probe, dispose of it properly (e.g. in containers for disposable needles). 1.10 ID 9 1.10 ID 9

1.15 1.13

ID 9 ID 9

Icare ic200 tonometer manual

ENGLISH

MEASUREMENT PRECAUTION If the tonometer is not used for 3 minutes, it will automatically switch itself off. PRECAUTION Do not use any anesthetic to numb the eye, an anesthetic can affect the measurement results (Badouin C, Gastaud P. Influence of topical anesthesia on tonometeric values of intraocular pressure. Ophthalmologica 1994; 208: 309–313). No anesthetic is required when performing measurements with this device.

t name: GUI Flowchart TA031 WARNING t number: TA031-GUI The tonometer device must not come into contact with the patient’s eyes. When adjusting the forehead resting support for the tonometer, do not accidentally the tonometer or probe into the eye. The tonometer’s forehead spacing support needs to be adjusted to maintain the tip of the probe about 5 mm, 04 push or about 3/16 inch, from the eye. During measurement, only the probe makes contact with eye, for a fraction of a second. 14.2017 When measuring, the tonometer and probe needs to be positioned approximately perpendicular to the surface at the center of the cornea of the eye. omi Lonka (Desigence)

STEP 1. Ask the patient to relax. Whether seated or standing, ask the patient to assume a straight and upright posture of their head and neck. Ask the patient to look straight ahead at a specific point. Bring the tonometer in front of the patient’s eye.

1.0

1.1

1.0

03/2017

:36:10

Correct head and eye position.

1.2

2.1

LOAD

EYE

OS LOAD

18/09/2017 2.0 07:37:45 AM

1.4

2.0

LOAD

1/100

EYEon the screen. If you have selected and confirmed the eye side or the patient ID, The tonometer is now Ready to Measure, indicated by the “Play” symbol displayed this information is also displayed on the screen. ID 9

OD OD LOADEYE

OS EYE

ID 9

OD OS OD OS LOAD EYE EYE

1.5

ID 9

OD OS EYE EYE

HISTORYOD EYE mmHg

EYE

OD OS EYE

1.6 1.7

ID 9

EYE

ID 9

EYE 2.4

OS 2.2

1.6 1.8 www.icaretonometer.com

ID 9

1.9

18 07:

12.6

OS OS 2/100

HI EYE m

OD OD EYE

2.3

07:37:45 AM

18/09/2017 1.8 07:37:45 AM

17.4

mmHg

ID 9 ID 9

1.5

18/09/2017 1.6 2.1 07:37:45 AM

Patient ID selected18/09/2017

Ready to measure display with the eye’s side selection options: OD, no information, OS.

2.1

ID 9

mmHg

2.2

1.2 1.3 1.6

EYE

17.4

Incorrect head and eye position.

2.2

18 07:

17.4 17.2 17.8 ID 9 18.2 ---- ----

OD ID 9

3/100

1/100 2.5

2.3

18/09/2017 07:37:45 AM

12.6

BACK ID 9 OS 2/100

mmHg

HISTORY mmHg

STEP 2. You may choose to annotate the measurement result with the eye’s side (right/left) information. Note that the device’s default selection is NO eye side OD OD ID 9 OD OS information.MEASURE Select between the OD (right eye) and the OS (left eye) by pressing the Navigation buttons.

EYE

MEASURE

mmHg

URE

2.0

18 07:

RETURN TO MENU

17.4 18.2

2.2 1.6

12.6

Icare ic200 tonometer manual

EYE

mmHg

ID 9

18/09/2017 07:37:45 AM

ENGLISH

2/100

STEP 3. Ensure that the forehead support is fully extended by turning the forehead support adjustment wheel. In order to perform a successful measurement, the distance from the tip of the probe to the patient’s cornea (see picture) should be about 5 mm (about 3/16 inch).2.3 Bring the tonometer in front of the patient’s 18/09/2017 eye with the probe pointing to the center of the cornea until the forehead support touches the forehead. Do not accidentally push the tonometer or probe into 07:37:45 AM the eye. Adjust the probe -cornea distance for your patient by turning the forehead support adjustment wheel.

17.4 17.2 17.8 18.2 -------

ID 9

3/100

2.4

~5 mm

2.5

BACK 2/100

(3/16”)

I C

RETURN TO MENU

Always adjust the position of the tonometer such that the probe is pointing towards the center of the cornea and is perpendicular to the surface of the cornea.

Correct device position.

Incorrect device position.

12: PRINTER MENU STEP 4. An IOP measurement can be performed using the tonometer either in Single Mode or in Series Mode. Each IOP measurement is calculated from six individual and consecutive rebound measurements:

14.3

16.6 CHANGE

OD mmHg

Single Mode: Press the Measure button gently but firmly. As when taking a picture with a camera, do not shake the tonometer. The tip of the measurement probe will make contact with the central cornea. Take six measurements. The grey segments of a circle on the display screen will turn blue one by one. In addition, the device will emit a short “beep” sound after each successful measurement. Series Mode: Press and hold the Measure button down. The device will automatically make a series of measurements. After the first successful measurement, one segment of the circle will be lit blue, additional segments will turn blue as the tonometer continues to measure. Measuring in Series Mode will take just a few seconds.

If Printer is not found

If the tonometer detects an error occurring during the measurement, it will beep twice and an error message will be displayed. To remove the error message from the display, press the Measure button and proceed to the measurements. For more information about error messages, see Error and Info Messages in this manual.

14.6

12.8

REPEAT IF PRINTER www.icaretonometer.com CONNECTED 14.9

12.0

PRINTER NOT FOUND 9

17.6

OD OD mmHg mmHg

mmHg

OD mmHg

Icare ic200 tonometer manual PRINT ENGLISH

1.15

ID 9

1.14

IF PRINTER 1.15 CONNECTED

.5 .8 17.4 1623

ME21 IF PRINTER CONNECTED

ID 9

1717 .4 .4

STEP 5. Once six measurements have been successfully made, the tonometer will emit one long beep sound. The final IOP measurement is displayed in large digits, in mm Hg, inside a colored circle on the display screen. The colors indicate the quality of the IOP measurement. Green indicates “good” (a low variation 12.0 12.0 12.1 of the observed parameters of probe motion during the four individual measurements used in the calculation of the final IOP), yellow indicates “acceptable” mmHg mmHg measurement quality. OD mmHg OD mmHg mmHg If the variation in the measurements is too high, the tonometer will display the Repeat symbol on the display screen. A new measurement series can be initiated by pressing the Measure button once.

ID 9

.5 .5 17.4 1616 mmHg

1.16

PRINT ME21

PRINTING... PRINT RECEIPT ME21

1.16

12.1 mmHg OD mmHg

17.4 mmHg

12.1

REPEAT

The values from the first to the fifth value displayed before the sixth value are running average values. The sixth value is the final IOP value which is calculated PRINTING... PRINTING... from the best four individual measurements (the worst two individual measurements are discarded).

1.17

ID 9

16.5

1.16

RECEIPT

1.18

STEP 6. After an IOP measurement has been successfully made from one eye, you may measure the IOP in the other eye (or make a repeat measurement in the same eye) by repeating the steps 1-5 above. The device does not automatically switch from one eye to another after one eye is measured, e.g. from OD to OS. When you have finished your IOP measurement session, hold the device so that the probe is horizontally or slightly downward tilted, press the Select button for three seconds to turn the tonometer off. The mmHg OD probe comes out from the probe base and you can remove it. Discard the probe (according to instructions). Retrieve the probe base cover and place over the probe base.

REPEAT

Note: When the tonometer is not in use, always keep the probe base covered to protect the probe base from contamination. If you doubt the validity of any of the tonometer’s displayed measurements of IOP (for example, if you suspect that the probe missed the central cornea or made contact with the eyelid), it is recommended that you repeat the measurement. In addition, if you observe an unusually high or low displayed value of IOP, it is recommended that you make another measurement, either with the Icare tonometer or using an alternative method in order to verify the unusual reading.

1.18

1.17

1.18

If you are unable to complete six successful measurements in a sequence, the measurement process can be terminated by pressing the Select button once. In such an instance, the results of the measurement attempt can be viewed in the device’s HISTORY menu. Note that in cases of unfinished measurements, IOP data from the individual steps are displayed with no indication of measurement validity.

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2.0 2.0

EYE 1.0

OD HISTORY EYE mmHg

1.1

1.2 2.0

2.1

BLUETOOTH EXPORT

4.0

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4.1 3.0

17.4

OFF

1.4 SOUND

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mmHg

ID 9 ID 9 ID 9 BLUETOOTH BLUETOOTH PATIENT ID EXPORT OD 740A ID 9 7.0 6.1 HISTORY ID 1 1/100 4.4 6.2 mmHg OS LOAD LOAD OD OS OD OS 5.3 YE R MENU 4.3 EYE EYE

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3.0

1.6

4.0

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2.3

mmHg

3.1 3.0 AM 3.2 07:37:45 MEASURE –2.1 Access to the measurement features 18/09/2017 LIGHT SOUND SOUND 07:37:45 AM If no LIGHT probe is detected in the probe base, the “LOAD” text and graphics are OF BRIGHTNESS LIGHT SOUND OFF OF .6 ID 1 740A OFF displayed. After a probe is loaded, the eye side to be measured first can be SOUN PATIENT.4 ID BLUETOOTH BLUETOOTH BLUETOOTH .6 OS .4 PATIENT ID BLUETOOTH BLUETOOTH PATIENT ID BLUET selected. TheHISTORY tonometer 9 OD IDOD PATIENTPATIE ID OFF 1 OS 2/100 OD OD OS OD OS7.0EXPORT PATIENT IDwhen the Play-symbol ID is 9 ready for measurement OD 740A OSOS 6.1 EXPORT ID 1 5.2 8.0 9.0 740A 1/100 2/100 EYE appears on display1/100 screen. EYE ID 1 6.2 EYE EYE 6.2 themmHg 7.1 18/09/2017 07:37:45BLUETOOTH AM

mmHg

2.1 1.5

BLUET PATIE 74 ID

18/09/2017

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6.0 5.0 4.3

4.2

6.1 5.1

4.4 2.2 3.2 measurements 3.1 2.1 – Previous HISTORY 3.3 07:37:45 AM 18/09/2017 3.2 18/09/2017 17.4 17.2 17.8 OFF BRIGHTNESS 07:37:45 The latestOFF measurement isAM displayed first LANGUAGE in HISTORY. The color of the OFF DATE BLUETOOTH 07:37:45 AM SOUND ID 9 17.4 17.2 17.8 18.2 ---- ID02 ---LIGHT ID 1 BRIGHTNESS SOUND displayed result indicates the measurement quality. The horizontalLIGHT arrow16.03.2017OFF ID SOUND SOUND ENGLISH BLUETOOTH 18.2 ------SOUND BLUETOOTH BLUETOOTH BLUETOOTH PATIENT.6 ID BLUETOOTH .6 orID sitting3/100 .4 standing the patient's position,BLUETOOTH the oblique arrow a tilted PATIENT ID indicates BLUETOOTH BLUETOOTHBLUET PATIENT ID BLUETOOTH OFF OS PATIENT IF PRINTER 8.0 10.0 11.0 9.0 PATIENTPATIE ID PATIENT ID EXPORT 740A OD ID OS OFF 9 OD OS 5.3 8.1 6.3 position, and the vertical arrow supine position. 3/100 2/100 9.1 EXPORT 740A OFF ID7.1 1 ME CONNECTED IF PRINTER 2/100 18/09/2017 1.607:37:45 OFF AM

OD EYE

4.0 2.3 3.2

18/09/2017 2.4 OFF AM 1.6 07:37:45

EYE

18/09/2017 2.5 BRIGHTNESS 07:37:45 AM

3.0

18/09/2017 07:37:45 AM LIGHT

17 12

OS 12: PRINTER MENU 4.1

4.3

3.1

mmHg

2.0 1.2

mmHg

2.0

2.1

3.0

mmHg

1.4

ID 9 BLUETOOTH SOUND UETOOTH EXPORT OFF HISTORY OS OD OS MEASURE OD OS 6.0 mmHg 4.3 YE LOAD EYE OD EYE LOAD 5.2 OS 0 4.1 EYE 3.1

3.0 2.1

2.0

ENGLISH

OD ID 9 OD.4 OS HISTORY PATIENT ID the The Icare ic200 tonometer color display screen as part of its user interface. Three buttons below screen allowIDthe userBLUETOOTH to control the MEASURE HISTORY PATIENT LOAD device uses a large, LOAD OS OD 1/100 EYE OD OD 4.0 OS 5.0 4.2 ID 9arrows) 5.1 4.1 Navigation EXPORTis for 6.0 mmHg ID 1 device. Pressing either of the two buttons (right/left allows for changing a selection in a displayed menu, the center Select button EYE mmHg 1/100 EYE 5.0 6.0 5.1 6.1 7.0 activating a selection. The large 3.0 Measure button located on the handle is used for starting the measurement function. 5.0 4.0 4.2 4.1 2.2 mmHg

1.1 1.0 ID 9 1.6

HISTORY PATIENT ID mmHg ID 1

18/09/2017 07:37:45 AM

USER INTERFACE FUNCTIONS

Icare ic200 tonometer manual

mmHg

4.0

3.0

mmHg

MEASURE OS

mmHg

1.0

1/100 6.3 7.2 CONNECTED5.2 4.4 2.5 5.0 4.2 2.4 EN PRINTER MENU – Add3.3an18/09/2017 identification to 12: a measurement 4.3 2.2 ID 2.3 3.2PATIENT

4.4

6.2 5.1 5.2 DMY 3.3 TIME3.2 4.5 FORMAT

12: PR

18/09/2017 DATE LANGUAGE The user assign an ID number from one to ninety-nine to any 07:37:45 AM BLUETOOTH OFF can 07:37:45 SOUND AM OFF ID LIGHT BRIGHTNESS LANGUAGE ID 9 17.4 SOUND 17.21 17.8 16.03.2017 OFF during OFF ENGLISH ID 1 If a17.4 LIGHT BRIGHTNESS ID02 measurement. Patient ID is selected, it will be shown the17:15 17.2 17.8 ID 1 ID ENGLISH DD.MM.YYYY 1.9 ID 9 18.2 ME21 ------ID 9 BLUETOOTH LIGHT SOUND BLUETOOTH 18.2 ---PRINT BACK RETURN measurement sequence and---in the device’s measurement SOUND HISTORY. SOUND PATIENT IDID 9 BLUETOOTH BLUETOOTH PATIENT ID PATIENT ID BLUETOOTH BLUETOOTH SOUND BLUETOOTH OS PATIENT ID BLUETOOTH PATIENT ID PATIENT ID OD ID 9 PRINT BACK RETURN 8.1 10.1 7.1 9.1 11.1 .2 ME21 ME21 OS TO MENU PATIENTPATIE ID 6.4 EXPORT 740A 7.2 OFF 2/100 3/100 5.4 8.2 ID 1 3/100 9.2 ME21 2/100 6.3 IF PRINTER 1/100 BLUET 5.0 6.0 MENU 6.1 6.4 7.0 7.3 IF PRINTER 8.0 2/100 ME21 OD OS OD OS 5.1 5.4 2/100 OD OS TO CONNECTED 5.36.0 6.3 4.2 5.1 6.1 CONNECTED 4.4 EYE 4.5 5.0 ENBLUETOOTH DMY 247.0 H5.3 Icare 5. E ® EYE EYE 13: PC/ MOBILE MENU4.4 – Wireless connection 12: PRINTER MENU 4.3 2.3 OD mmHg 3.3 FI 2017 5.2 3.1 3.2

2.4 18/09/2017

12.6 17.6

12.6

mmHg

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mmHg

17.4

mmHg

ID 9

1.7

18/09/2017 2.5

3.2

2.4

2.3

12: PRINTER MENU

4.4 ® The tonometer can be paired with a Bluetooth printer for printing the 2.518/09/2017 12: PRINTER MENU

3.3

3.3 4.5 LANGUAGE FORMAT FORMAT 13: PC/ MOBILE MENU AM SOUND KIELI BRIGHTNESS 13: PC/ 4.6LANGUAGE measurement07:37:45 results or with a computer for transfering the4.5 measurement YEAR OFF BRIGHTNESS LIGHT LIGHT BRIGHTNESS LIGHT ENGLISH DD.MM.YYYY hh:mm ID02 ID 1 17.2 17.8 ® ID02 SOUMI of this DD.MM.2017 For17.4 details, see the Bluetooth section document. BRIGHTNESS LIGHT LIGHT SOUND results. LIGHT SOUND 10.0 11.0 ENGLISH 18.2 ------BLUETOOTH SOUND BLUETOOTH PRINTING... SOUND BLUETOOTH PRINT PATIENT ID PATIENT ID 10.0 11.0 9.0 10.2 9.2 8.2 .3 PRINT RETURN ME21 PATIENT ID BLUETOOTH 7.3 BACK 9.3 PRINTING... 8.3 8.0 10.0 9.0 RECEIPT 5.5 6.5 ME21 3/100 ME21 6.2 BLUETOOTH 8.1 RETU 2/100 TO MENU 6.1 7.0 7.1 IF PRINTERME21 7.4 5.5 6.5 CONNECTED Icare EXPORT 8.0 RECEIPT 6.4 SOUND – 5.4 Adjusting the beep volume CONNECTED Icare EXPORT FI 2017 17 OD mmHg 5.2 7.1 6.2 4.6 TO M 5.4 5. GHTNESS INFO 5.3 SVaddition TIME LANGUAGE 2.3 3.3 4.4 DATE The offers three sound levels, in to a silent mode. The 03 .4 2.5 18/09/2017 4.5 EN 3.2 12: tonometer PRINTER MENU 3.3 2.4 2.5 ODAMmmHg BRIGHTNESS 1733RM001 LIGHT INFO 13: PC/ MOBILE MENU 16.03.2017 17:15 DATE TIME ENGLISH LANGUAGE 4.5 KIELI YEAR HOURS LIGHT 07:37:45 BRIGHTNESS 4.6 sound level is indicated with a 3-level bar. 13: PC/ MOBILE MENU SOUND BRIGHTNESS LIGHT LIGHT DATE 4.5 BRIGHTNESS SPRÅK MONTHMENU LIGHT LANGUAGE 4.6 13: PC/ MOBILE ID02 1733RM001 16.03.2017 17:15 1.11SOUND ENGLISH ID 1 17.8 17.4SOUND 17.2 LIGHT BRIGHTNESS LANGUAGE DD.MM.2017 17:mm BRIGHTNESS SOUND BRIGHTNESS LIGHT ID02 SOUMI LIGHT LIGHT IDSOUND 9 LANGUAGE 16.03.2017 SVENSKA DD.03.2017 ENGLISH LIGHT SOUND 18.2 ------- 8.1 LIGHT BRIGHTNESS 10.1 9.1 11.1 SOUND 8.0 10.0 11.0 9.0 RETURN ENGLISH SOUND PRINT 7.0 1.10 ENGLISH BLUETOOTH 8.0 10.0 11.0 9.0 SOUND PATIENT ID ID 9 PRINT SN RETURN 1.9 BACKPATIENT ID7.1 10.3 7.3 9.3 .4 BLUETOOTH 8.3 PATIENT ID 8.1 10.1 9.1 11.1 9 TO MENU PRINT PRINTING... BACK RETURN R ME21 ID 3/100 ME21 BLUETOOTH PRINTING... 8.1 10.1 6.2 9.1 6.1 2/100 IF PRINTER 8.47.2 12: PRINTER 9.4 6.5 ME21 7.1 DMY 1733RM001 EN 24 TO 7.0 MENU 8.0 10.0 9.0H RETURN BLUETOOTH D 5.3 8.2 SN 11.0 6.37.4 MENU Icare EXPORT RETURN LIGHT – Adjusting the Probe base brightness RECEIPT MENU 8.1 5.2 7.1 light ME21 6.2 2/100 CONNECTED OD Icare EXPORTTO mmHg RECEIPT TO MENU SVThe 03 can be adjusted 15 5.3 7.2 6.3 12: PRINTER 1733RM001 EN MENU DMY 24 Hto 5.5 of 6.5MENU Icare EXPORT intensity the Probe base light one of three levels, or If Printer is connected TO 5.5 16 12: PRINTER MENU 5.4 DMY DE DATE TIME GHTNESS LANGUAGE FORMAT FORMAT EN INFO SW LANGUAGE 3.3 BRIGHTNESS OD mmHg DATE switched OFF state. The intensity TIME LANGUAGE 2.5 of the light is indicated with INFO a 3-level bar. EN FI 4.6 OD mmHg 12.2 1733RM001 BRIGHTNESS SPRÅK MONTH MINUTES LIGHT 16.03.2017 17:15 ENGLISH DD.MM.YYYY hh:mm 1.00 AFORMAT ENGLISH BRIGHTNESS LANGUAGE FORMAT SW 4.5 4.6 1733RM001 16.03.2017 17:15 ENGLISH 13: PC/ MOBILE MENU 1.12LIGHT ID BRIGHTNESS LANGUAGE FORMAT BRIGHTNESS LIGHT SPRACHE DAY LIGHT BRIGHTNESS 12.2 12.4 12.7 12.9 DATE TIME 9 SVENSKA DD.03.2017 4.6 17:15 ID02 LIGHT BRIGHTNESS SOUND ENGLISH LANGUAGE DD.MM.YYYY hh:mm 1.00 KIELI A LIGHT BRIGHTNESS LANGUAGE 10.0 11.0 9.0 SOUND ENGLISH DD.MM.YYYY 17 DEUTSCH 16.03.2017 16.03.2017 17:15 ENGLISH LIGHT SOUND 10.0 11.0 9.0 10.2 9.2 8.2 1.11 LIGHT BRIGHTNESS SOUND 8.1 10.1 9.1 11.1 SOUMI ID 9 SOUND SOUND 1.10 10.0 11.0 9.0 ENGLISH 8.1 10.1 7.1 9.1 11.1 PRINTING... ID 9 ID7.28.0 PATIENT PRINT SN RETURN 10.2 9.2 8.2 7.0 PRINTING... 8.4 7.4 9.4 .5 8.0 10.0 11.0 9.0 RETURN SN PAIR10.2 6.3 7.2 2017BLUETOOTH 9.2 BRIGTHNESS 8.2 – Adjusting the brightness of the display screen RECEIPT 7.3 PRINTING... 6.4 FI mmHg 17 8.1 7.1OD 9.1 11.1 ME21 1733RM001 EN 5.4 24 H RETURN DMY RECEIPT TO MENU 8.3 mmHg PAIR10.1 TEST RETURN TO MENU 5.3 7.2 8.2 6.3 1733RM001 EN OD DMY The brightnessPAIR 24 H can NEW of the display be set to one of three levels. The RECEIPT 7.3 6.4 screen SN 12: PRINTER MENU Icare EXPORT TO MENU 5.4 FI 2017 17 INFO If Printer is connected DE 16 DATE TIME 12: PRINTER MENU mmHg ANGUAGE ME21 ME21 If Printer is conne INFO TO MENU NEW DATE TIME NGUAGE FI OD mmHg KIELI YEAR HOURS GHTNESS brightness level with a 3-level bar. 5.5 201724 H LANGUAGE FORMAT SW 17 EN FORMAT DMY If Printer is not found SV INFO HTNESS DATE TIMEis indicated 1733RM001 OD LANGUAGE mmHg 16.03.2017 17:15 ENGLISH BRIGHTNESS LANGUAGE FORMAT FORMAT SW FI 1733RM001 16.03.2017 17:15 NGLISH13: PC/ MOBILE MENU If Printer is not found SOUMI DD.MM.2017 17:mm KIELI YEAR HOURS BRIGHTNESS INFO BRIGHTNESS SPRACHE DAY BRIGHTNESS LIGHT ENGLISH DD.MM.YYYY hh:mm 1.00 A TIME DATE 1.13 LANGUAGE 1733RM001 16.03.2017 17:15 ID 9 ENGLISH 12.2 12.4 12.7 12.9 4.6 DD.MM.YYYY 1.00 A ENGLISH KIELI hh:mm YEAR LIGHT BRIGHTNESS BRIGHTNESS 12.2 12.4SPRÅK SW LIGHT LANGUAGE FORMAT BRIGHTNESS LIGHT SOUND SOUMI DD.MM.2017 FORMAT 1733RM001 DEUTSCH 16.03.2017 16.03.2017 17:1512.8 ENGLISH10.1 10.0 11.0 9.0 1.12 KIELI LIGHT BRIGHTNESS17:mm SOUND 12.3 9.1 11.1 10.3 SOUMI DD.MM.2017 9.3 ID9.1 9 8.3 BRIGHTNESS LIGHT SOUND 10.2 ENGLISH 11.1 DD.MM.YYYY hh:mm 1.0 10.1 1.11 8.2 SVENSKA12.1 9.2 ID 9 12.3 SN 12.6 12.8SOUND 12.8 7.2 8.0 SOUMI 13:10.3 PC/ MOBILE MENU 10.1 9.1 11.1 10.09.2 11.0 10.2 9.08.2 SN 7.38.1 9.3 .. 8.3 LANGUAGE – Language setting SN 8.1 13: PC/ MOBILE MENU 10.1 9.1 11.1 PRINTING... 10.3 6.4 7.3 24 H 9.3 1733RM001 EN 7.1 DMY 8.315 SV mmHg to PC/ of Mobile device already 1733RM001 DMY EN 2403 H8.2 RETURN 10.2 exists 7.2OD 9.2 If connection FI 2017 17 The user PAIR TEST UNPAIR P can24 change the language user interface from several 8.3 8.4 SN PAIR 7.3177.4 the 1733RM001 6.4 6.5 2017 T 5.4 5.5 EN RECEIPT DMY H FI If Printer is connected PAIR 12: PRINTER MENU SV TO MENUINFO NEW 03 15 ME21 PRINTER DATE TIME If Printer is connected 12.7 12.9 13.0 7.4 SEARCHING... ME21 ME21 5.5 6.5 languages. 12: PRINTER MENU 12.5 OD OD mmHg mmHg SW MINUTES SV ANGUAGE FORMAT FORMAT 1733RM001 EN DMY 24 H If Printer is connected M 03 GHTNESS SPRÅK MONTH NEW OD mmHg NGUAGE FORMAT FORMAT SW 13.0 13.5 13.6 13.8 KIELI YEAR PRINTER SEARCHING... 2017 FI HOURS 17 1733RM001 FOUND FOUND 1DE 16.03.2017 17:15 PAIRED PRINTING... INFOHOURS DATE TIME HTNESS LANGUAGE FORMAT SWNOT YEAR BRIGHTNESS KIELIis not found FORMAT LANGUAGE SV ENGLISH DD.MM.YYYY hh:mm 1.00 A If Printer SVENSKA12.4 DD.03.2017 17:15If 1Printer is not found 12.2 SOUMI 12.7 12.91.00 A MONTH BRIGHTNESS SPRÅK MINUTES NGLISH DD.MM.YYYY hh:mm 12.5 DD.MM.2017 17:mm NOT FOUND FOUND LANGUAGE FORMAT FORMAT SW TEST 1.14 BRIGHTNESS 1.15 12.4 12.7 17:mm 1733RM001 BRIGHTNESS SPRÅK M LIGHT ID 9 16.03.2017 12.5 17:15 DD.MM.YYYY hh:mm 1.00 AME21 12.9 MONTH ENGLISH DD.MM.2017 SOUMI 12.2IF PRINTER ENGLISH KIELI YEAR HOURS LIGHT BRIGHTNESS 12.2 12.4 SVENSKA DD.03.2017 17:15 SPRACHE BRIGHTNESS LIGHT SOUND 10.1 CONNECTED IF PRINTER SPRÅK LIGHT ENGLISH DD.MM.YYYY 1.00 A 10.0 11.0 10.2 ID 9.2 9 SOUND 9.1 1.13 11.1 SVENSKA hh:mm BRIGHTNESS DD.03.2017 1.12 10.3 9.3 ID 9 TEST UNPAIR BACK PAIR 10.2 9.2 SOUMI DD.MM.2017 17:mm BRIGHTNESS LIGHT 12.8 SOUND CONNECTED 12.610.3 12.10 SVENSKA 12.8 8.4 9.4 10.0 11.0 12.3 9.08.3 DEUTSCH 9.3 SN 12.3 12.6 12.8 10.2 – Setting11.1 9.2 8.2 DATE of the date displayed CK PAIR PAIR on the device TEST UNPAIR& OBILE 7.3 MENU 14: ERRORs 8.1 10.1 9.18.3 12.0 ME21 7.4 ME21 If connection NEW 8.4PC/ Mobile 9.4 10.2 7.2 8.2 to device9.2 already exists NEW 1733RM001 24 H DMY PAIR FI 2017 17 SN PAIR TEST UNPAIR BACK The date shown on the device can be set in one of several formats: IS0 8061 740A 740A 740A 10.3 7.3 9.3 .0 FI 8.4 13: PC/ MOBILE MENU 7.4 PAIR 9.4 2017 17 SV 6.5 03 15 DE mmHg 168.3 PAIR TEST UNPAIR 12.4 12.5 OD mmHg PC/ Mobile Device SV 15 If PC/(D.M.Y). FI 2017 17 PAIRMOBto If13: connection ME21 ME2112.42403 ME21 1733RM001 ENOD DMY H (Y-M-D), USA (M/D/Y) PAIR setting the8.4 and the common However, date is 5.5 mmHg 7.4 6.5 IfMENU Printer is connected NEW 12:FORMAT PRINTER INFO 12.5 If PC/ Mobile Device DATE TIME 16 ME21 ME21 is not found FORMAT 13.0 13.5 13.8 IfDE Printer 13.6 is SW connected NEW OD mmHg ODYEAR KIELI HOURS FI PRINTER 2017 17 ME21 mmHg ME21 SEARCHING... 16 15 INFO NEW always performed in theDEstandard format order of: PRINTING... YEARMONTHDAY. HOURS YEAR SPRÅK MINUTES DATE TIME SPRACHE GHTNESS DAY is MONTH not found SV 03 PAIRED CONNECTION dKIELI PRINTER SEARCHING... 1733RM001 03.2017 17:15 BRIGHTNESS SPRÅK MINUTES PA DD.MM.YYYY hh:mm 1.00 FORMAT AMONTH YEAR HOURS HTNESS KIELIis not found PRINT 12.9 13.0 13.5 SOUMI DD.MM.2017 17:mm LANGUAGE FORMAT SW DE If Printer 12.5 NOT FOUND FOUND 1 1733RM001 12.8 12.10 13.4 13.1 SOUMI DD.MM.2017 17:mm 14.0 SVENSKA12.4 DD.03.2017 17:15 16.03.2017 17:15 DEUTSCH 16.03.2017 SPRACHE12.9 DAY BRIGHTNESS 12.7 ME21 TEST REMOVED If Printer is not found 12.5 NOT FOUND FOUND 1 KIELI YEAR HOURS BRIGHTNESS PRINT SVENSKA DD.03.2017 MB SOUMI DD.MM.2017 13.4 13.1SPRÅK 13.7 13.9 12.4 12.7 17:mm 13.1 12.9 ME21 SPRACHE DAY BRIGHTNESS LIGHT 12.2 ENGLISH 11.0 DD.MM.YYYY hh:mm 1.00 A 17:15 12.5 BRIGHTNESS MONTH MINUTES LIGHT PAIR DEUTSCH 16.03.2017 1.13ME21 10.3 9.3 SOUND11.0 10.2 DD.MM.2017 17:mm BRIGHTNESS 1.15 ID 9 10.1 IF PRINTERSOUMI 11.1 10.3 SPRACHE LIGHTPAIR 12.3 12.6 12.8 12.10 10.09.2 ID9.3 9 BACK DEUTSCH 16.03.2017 SVENSKA TEST DD.03.2017 17:15ME21 TIME – Setting of the device time PAIR PAIR UNPAIR 12.3 12.6 12.8 12.10 12.8 14: ERRORs & ALERTs CONNECTED 10.19.4 9.18.4 11.1 10.3 9.3 SN 8.3 device already 12.3 12.6 DEUTSCH 12.8 10.29.4 9.2 8.4 7.4 8.2 If connection to PC/ Mobile exists SN TheME21 time displayed on device can be selected to be either in the 12- or 740A 740A 740A 10.3the 9.3 TEST UNPAIRNEW PAIR 8.3 1733RM001 2403 H CONNECTION DMY 2017 17 BACK SV 7.3 15 12.1 CONNECTION WAITING... CHA PRINTING... PAIR TEST UNPAIR BACK SV PAIR 03 15 mmHg mmHg 12.0 24-h format. Setting the timeWAITING... is made in theUNPAIR sequence: DE 16 8.4 7.4 1733RM001 DMY 24 H PAIR16 BACK WAITING... PAIRING ME21 ME21 INFO NEW PAIR SV 159.4TEST .1 TIME 13.5 le Device DECONNECTION 13: PC/ MOBILE MENU 13.6 13.812.4 03 FI 2017 17 12.5 CANCELLED12.6 DEVICE TEST REMOVED ME21 ME21 ME21 NEW If PrinterOD is connected mmHg 12.4 12.5 OD mmHg SEARCHING... mmHg INFO FORMATHOURSMINUTES. ORMAT FORMAT SW YEAR HOURS TIME MINUTES MONTH SV 03 15 d SPRÅK ME21 DEVICE ME21 ME21 PAIRED PRINTING... CONNECTION DEVICE CANCELLED NEWCANCELLED 1733RM001 17:15 PRINTER SEARCHING... MONTH SPRÅK MINUTES If PC/ Mobile Device PAIRED PRINTING... CONNECTION SPRACHE DAY FORMAT FORMAT SW 12.6 DE 16 PRINTER SEARCHING... D 1 HTNESS MINUTES SPRÅK If PC/ Mobile D 1733RM001 14.0 MM.YYYY hh:mm 1.00 AMONTH DD.MM.2017 17:mm 17:15 SVENSKA 17:15 DD.03.2017 PAIRED SPRACHE DAY BRIGHTNESS ME21 TEST HOURS REMOVED KIELIFOUND YEAR is not found NOT FOUND 16.03.2017 FOUND If Printer is not found DD.03.2017 VENSKA 17:15 1 13.7 PRINTING... 13.1 13.1 13.9 NOT FOUNDMINUTES ME21 TEST REMOVED is not found DEUTSCH BRIGHTNESS SPRÅK 12.9 DD.MM.YYYY hh:mm 1.00 A MONTH 12.4 12.7 FOUND 1 12.5 SVENSKA DD.03.2017 17:15 PRINT ME21 DEUTSCH 16.03.2017 1.16 SOUMI DD.MM.2017 17:mm PRINTING... ID 9 11.1 SPRACHE DAY BRIGHTNESS LIGHT 11.0 RECEIPT 14.1 10.3 TEST SVENSKA 9.3 12.10 PAIR 13.4 13.1 13.1 DD.03.2017 17:15 INFO – Device System information UNPAIR 1.15 IF PRINTER PAIR BACKand ME21 10.1 11.1 PAIRED ID 9 10.2 9.4 SN 13.2 12.6 12.8 12.10 PAIR BACK 13.4 RECEIPT DEUTSCH 16.03.2017 12.10 9.4 10.2 9.2 CONNECTED 12.3 12.6 12.8 screen displays 12.8 13.2 13.3 the device 10.3 9.3 SN740A This INFO serial number (SN). Pressing the Select 740A 740A ME21 PAIRED 8.3 8.4 9.4 ME21 1733RM001 24 H ME21 13: PC/ MOBILE MENU 15 2017 17 button theMobile installed version CHANGE (SW) of the tonometer. 8.4 9.4 DE 7.4 16 1733RM001 2403H ME21shows NNECTION WAITING... WAITING... PAIRING If connection to PC/ devicesoftware already exists DE 16 PAIR TEST BACK 12.0 13:UNPAIR PC/ MOBILE MENU 2017 17 12.4 12.5 mmHg OD 12.1 SV 03 15 DE 16 INFO mmHg DEVICE FORMAT SW 12.4 12.5 If connection to PC/ Mobile device already exists ANCELLED DEVICE ME21 CANCELLED mmHg CONNECTION WAITING... W INTING... ME21 CONNECTION ME21 MINUTES MONTH REPEAT 12.4 12.5 mmHg YEAR HOURS SEARCHING...OD SPRACHE DAY DE PRINTING... 16 13.5 FORMAT SW 012345 CONN CONNECTION 1733RM001 13.0 12.6 13.6 13.8 hh:mm 1.00PAIRED A DAY PRACHE SEARCHING... CHA YEAR PRINTER HOURS 012345 12.6 CANCELLED DEVICE PAIRED PRINTING... CONNECTION TEST REMOVED PAIRED DD.03.2017 17:15 12.8 MM.2017 17:mm 13.1 13.7 13.9 SPRÅK MINUTES DAY HTNESS SPRACHE FOUND 1 If PC/ DEUTSCH 16.03.2017 hh:mm 1.00 AMONTH CAN 13.5 13.6Mobile Device740A 1 ME21 REMOVED 13.0 12.5 NOT FOUND 16.03.2017 FOUND 1 TEST EUTSCH DD.MM.2017 17:mm 12.8 ME21 TEST REMOVED SPRACHE DAY740A BRIGHTNESS is not found 740A14.1 SVENSKA DD.03.2017 17:15 14.3 PRINT DEUTSCH 16.03.2017 14.2 BACK 14: ERRORs & ALERTs PRINTING... 11.1 PAIR 10.3 PAIR BACK 16.03.2017 9.4 1.16 ME21 DEUTSCH 13.2 13.3 ID 910.2 PAIR SN 1.17 10.31.18 9.3 ME21 1114.4 www.icaretonometer.com 12.6 12.8 12.10 13.4 BACK RECEIPT 14: ERRORs & ALERTs PAIRED ME21 PAIR PAIR TEST PAIRED UNPAIR& ALERTs 14: ERRORs n to PC/ already exists 17Mobile 8.4 device 9.4 PRINTING... ME21 13.2 1733RM001 13.3 WAITING... PAIRING 13.3 03 15 If connection to PC/ Mobile device already exists BACK PAIR PAIR TEST 16 13: PC/ MOBILE MENU 13.8 17 NEWME21 740A ME21 740A PRINTING... 740A 13.3 TEST 03DEVICE 15 If connection to PC/ Mobile device already exists CANCELLED 12.5 NEW 740A 740A 12.1 13.6 13.8 HOURS DE 16 SWmmHg 12.4 12.5 TEST IfMINUTES PC/ Mobile Device ONTH 14.0 13.0 13.5 13.6 13.8 DAY CHANGE mmHg HOURS CHANGE D12.6 012345 PAIRED 12.6 CONNECTION 17:mm is not foundPRINTING... PAIRED CONNECTION MONTH MINUTES 07:37:45 AM LIGHT 07:37:45 AM BRIGHTNESS LIGHT ID02 OFF 17.4 ID 17.21 17.8 SOUND SOUND SOUND 1.8 1.10 ID 9 ------SOUND 9.0 PRINTER EXPORT BLUETOOTH 8.0 BLUETOOTH ID 9 ID 18.2 9BLUETOOTH PATIENT ID PATIENT PATIENT MODE ID7.2 MODE 1.9 OFF ID7.0 Icare EXPORT 8.0 RETURN OS ID 9 BACK ME21 IF PRINTER 3/100 6.4 6.0 6.1 7.0 IF 2/100 CONNECTED TO MENUPRINTER6.0 5.2 2/100 5.1 5.0

16.6

mmHg

12.6

17.6

17.623.9 23.920.8 20.816.5

23.9 20.8 16.5

16.6

17.6 16.6

23.8 17.4 16.517.6 16.6

16.5 23.8 17.617.4

17.4

TBD

16 .5 .4 16 17 8 .5 17 .4

5 .5 17.4 16

TBD

23.9 Author: Tomi Lonka (Desigence) 12.6 16.517.6 16.6 17.4 2017 .8 .6 2.2 OD mmHg

2.4

2.5

17.4

2.4

2.5 12: PRINTER MENU CONNECTED

18/09/2017 07:37:45 AM

3.2

2.4

2.5

mmHg

EYE OD mmHg

HISTORY ODmmHg OS

mmH

4.4 RECEIPT PATIENT ID BLUETOOTH EXPORT ID 1 OD ID 9 12.2 1 ID 1 LOAD 1.12 LOAD 1/100 4.0 1.9 EYE 2.0 4.2 4.1 PRINT 3.0 ID 9 PRINT BACK BACK RETURN RETURN ID 9 0.1 1.0 4.3 3.1 2.1 BLUETOOTH OS PATIENT ID ME21 2/100 ME21 18/09/2017 2/100 TO MENU TO MENU 1.11 2.2 1.9 ID 9 2/100 ME21 S 07:37:45 AM 18/09/2017 tonometer ID 9 3.2 BACK RETURN Icare ic200 ENGLISH 2.0 4.0PRINTmanual 4.1 3.0 1.4 1.5 1.6 OFF 07:37:45 AM PAIR ID 9 ID 9 ME21 2/100 TO MENU OD mmHg PATIENT ID BLUETOOTH BLUETOOTH OD HISTORY OD mmHg mmHg 2.3 NEW 18/09/2017 MEASURE 3.3 OD PATIENT ID EXPORT OS 740A mmHg ID12: 1 PRINTER MENU OD ID 9 OD OS 07:37:45 AM If Printer is connected OD mmHg EYE If Printer is not found 4.5 1/100 EYE OD mmHg OS 17.4 17.2 17.8 HISTORY PATIENT ID BLUETOOTH BLUETOOTH 1.0 2.0 2.0 4.0 ID02 2/100 1.10 3.0 4.2 3.0 1.13 ID 9OS---- ---OS OD OS OD9 18.2 OD OS 4.1 ID 3.0 4.3 3.1 4.0 2.1 EXPORT 740A ID 1 12.2 12.4 18/09/2017 PRINTING... PRINTING... 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If connection to PC/ device already exists If Mobile connection toENGLISH PC/ Mobile device 7.2 8.2 6.4already exist

ID 1 6.3

5.4 5.5 6.5 13: PC/ MOBILE MENU 13.0 13.5 13.6 BLUETOOTH 12.5 5.2OS 13.5 8.1 13.6 7.113.0(Low Energy) functionality 6.2 ic200 with PATIENT ID 4.55.3 results you first need to pair the To export12.5 the measurement the computer having a Bluetooth the Icare toEXPORT If connection PC/ Mobile device already exist If connection to PC/ Mobile device already exists 7.2 and 8.2FI 6.3 13: PC/ MOBILE MENU 2/100 4.6 means that you create a connection between the ic200 device and the computer. The connection (pairing) ME21 software running. Pairing is automatically stored, and 12: PRINTER MENU EN LIGHT BRIGHTNESS SOUND If Prin 13.6 KIELI 13.0 13.6 13.8 13.5 OD mmHg 12.5 if disconnected, resuming is fast and simple by activating the connection. Once13.5 the computer has been 13.0 paired, the export mode is active and the Icare EXPORT LI SOUND 2.3 SOUMI 18/09/2017 LI SOUND 3.3 software is running on the computer, measurements are sent. BACK PAIR PAIR TEST UNPAIR BACK PAIR PAIR LIGHT BRIGHTNESS LANGUAGE BLUETOOTH 07:37:45SOUND AM 12.2 5.0 12.4 LIGHTNEW4.2 BRIGHTNESS SOUND 4.0 5.1 4.1 4.5 3.0 740A 740A ME21 NEW 740A RETURN 13: PC/ MOBILE MENU ENGLISH 7.3 6.4 Icare EXPORT 17.4 17.2 17.8 1.12 5.4 8.3 ID 9 ID02 5.5 6.5 UNPAIR BACK TO MENU PAIR PAIR TEST UNPAIRPAIR 18.2 ------If PC/ Mobile Device If PC/ Mobile DevicePAIR To pair the ic200 device with the computer: is not found 5.3 7.2 8.2740A 740A 6.3 is not ME21 SV NEW NEW 740A PATIENT ID found 6.4 740A 7.3 8.3 5.4 4.6 • 3/100 Open the BluetoothPATIENT settings of the computer you wantBLUETOOTH to pair the ic2004.0 device with IF PRINTER 5.0 2.0 4.0 4.2 4.2 PAIR 4.1 4.1 SOUND BLUETOOTH BLUETOOTH BLUETOOTH EXPORT 3.0 3.0 If PC/ Mobile Device If PC/ MobileCONNECTED Device ID 13.4 13.1 13.1 13.7 13.4 13.1 13.1 13.7 SPRÅK ODthe OD mmHg and make issure Bluetooth mmHg BRIGHTNESS LIGHT SOUND is ON. FI MODE U is not found not found NEW EXPORT 740A ID 1 OFF Icare EXPORT

20.8 16.5

16.6

LI SOUND • Navigate into the Bluetooth menu of the ic200 device and select EXPORT MODE. SVENSKA If Printer is not found KIELI LIGHT13.4 13.1 SOUND 13.4 13.1 13.7 BRIGHTNESS 13.9 BRIGHTNESS 13.1 13.7 • Select PAIR NEW. RETURN LIGHT 13.1 SOUND 5.2 1.13 3.1 ID 9 4.6 ORY HISTORY PATIENT ID ic200 PATIENT The ID 4.3 BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH SOUMIBLUETOOTH • The ic200 will <serial number of the device>. can CONNECTION WAITING... WAITING... TO MENU 8.4 5.5 display WAITING… 7.4 6.5 pairing CONNECTION WAITING... WAITING... NNECTION EXPORT EXPORT 740A 12.3 OFF OFF mHg mmHg ID 1 ID 1 12.6 12.8 740A be canceled by pressingOFF the Select button. CANCELLED DEVICE DEVICE CANCELLED DEVICE DEVICE OFF EMOVED 5.4 7.3 6.4 8.3 PRINT RETURN DE • The ic200 is nowCONNECTION available for pairing 3.0 and visible as a Bluetooth device in4.0 the 5.0 4.2 4.1 8.4 5.5.6 7.4 6.5 WAITING... WAITING... PAIRING CONNECTION WAITING... WAITING... NNECTION ME21ID TO MENU 4.3 4.3 3.1 3.1 2.1 computer. OD mmHg PATIENT BLUETOOTH SOUN RETURN name: GUI Flowchart TA031 /2017 18/09/2017 Document SV CANCELLED DEVICE DEVICE CANCELLED 1838BM001 1838BM001 EMOVED SPRACHE BRIGHTNESS CANCELLED LIGHT SOUND • Select the ic200 device from the device list of the Icare EXPORT software. 45 AM 07:37:45 AM Document TO MENU PRINTER SEARCHING... number: TA031-GUI DEUTSCH OFF 13.3 OFF13.3 OFFinstance 740A, OFF 13.2 13.2 BRIGHTNESS • TheSOUND pass key and the mac id of the connection, for will appear on the SPRÅK 1 LIGHT NOT FOUND FOUND Revision: 05- Pikamuutokset ORY PATIENT ID BLUETOOTH BLUETOOTH BLUETOOTH BRIGHTNESS LIGHT SOUND .4 .4 5.3 display of the ic200 device for 30 seconds. 4.4 SVENSKA 1.14 1.15 3.2 IF PRINTER 12: PRINTER MENU PATIENT ID PATIENT ID Date: 17.8.2018 ID 9 13:BLUETOOTH PC/740A MOBILE MENUBLUETOOTH OFF 9 9 the OD• ID EXPORT mHg ID Enter pass key to the Icare EXPORT software to1pair the devices. CONNECTED 13.2 13.3 13.2 13.3 If c 100 1/100 Author: Tomi Lonka (Desigence) • After a successful pairing, will display PAIRED with the mac ID 1the ic200 device 5.0 4.0 id. 4.2 PAIRED 8.4 012345 3.0 5.5 7.4 4.1 6.5 012345 PAIRED PRINTING... 12.0 4.3 • .8 The device returns to.4 main menu and3.1 displays the BLUETOOTH EXPORT and the mac 2.7 12.9 13.0 13 12.5 /2017 2.2 740A 740A 4.4 BLUETOOTH 740A 4.4 SOUN RECEIPT PATIENT ID 12.4 12: PRINTER MENU 740A 12.5 MENU /2017 18/09/2017 mmHg 3.2 3.2 12:DE PRINTER 45 AM id in turn on OD the mmHg screen. ME21 012345 45 AM 07:37:45 AM 012345 PAIRED PAIRED OFF 4.1 OFF • If the pass key is incorrect, ic200 will display PAIRING ERROR. The 2.0 2.0 4.0 4.0 4.2 4.2 4.1 3.0 3.0error needs to be ID 1740A ID 1 740A 740A ORY PATIENT ID BLUETOOTH BLUETOOTH BLUETOOTHSPRACHE 740A .4 BRIGHTNESS LIGHT SOUND PRINT acknowledged by pressing the Select button. .6 .6 PATIENT ID BLUETOOTH

TBD

mmHg

mmHg mmHg

12 16.5

T T

mmHg

7 2

TBD

2.5

PC/740A MOBILE MENU TEST UNPAIR PAIR 5.4 13.3 EXPORT OFF DEUTSCH IDBACK 1 3.3 13.3 13:BLUETOOTH BLUETOOTH ME21 OS PATIENT ID PATIENT ID PAIR BACK If c ME21 ME21 NEW 4.5 2/100 ME21 ME21 ME21 13: PC/ MOBILE MENU HISTORY HISTORY PATIENT ID PATIENT ID BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOT PAIRING TURN ID02 4.3 If PC/ Mobile Device 2.7 13.0 13 13.3 13.3 To activate the12.9 pairing with the computer: 3.1 (if12.5 Bluetooth is turned off) /2017 4.4EXPORT 740A OFF mmHg ID 1 ID 1 is not EXPORT found ERROR OFF OFF /2017 2.3 12.1 3.2 12:740A PRINTER MENU SOUN 45 AM •mmHg Go to EXPORT MODE. /2017 18/09/2017 mmHg mmHg 3.3 3.3 PAIRED PATIENT ID PAIRED 45 AM 12: PRINTER OFF OFF If Printer is connected 45 AM 07:37:45 AM MENU NTER Select button and ACTIVATE appears. ID 4.0 4.2 5.1 4.1 2.8 13.4 13.1 13 12.6 4.5 BLUETOOTH 740A 3.0• Press the12.10 740A 4.5 5.0 1 13: ECTED 4.3 4.3PC/ MOBILE MENU13: PC/ MOBILE MENU 3.1 3.1 2.1 .2 17.8 17.42.1 17.2 17.8 • Press 18/09/2017 the Select button to activate the exportPATIENT mode the connection ID02and ID02 with the Icare EXPORT 18/09/2017 ID BLUETOOTH TEST UNPAIR BACK PAIR PAIRED PAIRED 13: PC/ MOBILE MENU --9 ---18.207:37:45 ---- AM---BLUETOOTH AM PRINTING... 12.2 12.7 12.9 paired07:37:45 computer. PATIENT ID12.4 5.5 12.5 100 ME21 ME21 NEW 740A OFF OFF 740A exists 1.16 OFF ID OFF If connection to PC/ Mobile device already PATIENT PATIENT ID 9 100 ME21 RECEIPTID 100 3/100IF PRINTER IF PRINTER PAIRED CONNECTION 4.6 SOUND SOUND 13: PC/ MOBILE MENU 13.0 BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH BLUETOOTH CONNECTION WAITING... EXPORT ACTIVATE PRINTING... PATIENT ID CONNECTION If PC/ Mobile Device 13.6 13.8 CONNECTED PATIENT ID PATIENT ID13.5 BLUETOOTH BLUETOOTH If connection to PC/isMobile device already exists OD ID 9CONNECTED ODID ID not found ME21 MODE 740A 1 9 OFF 4.4 /2017 Icare EXPORT EXPORT CANCELLED Icare DEVICE 3.2EXPORT TEST REMOVED 12:740A PRINTER MENU ACTIVATED /2017 To test the activated computer: 3.3 1/100 1/100 45 PAIR TEST UNPAIR BACK SOUN PAIR NT 45 AM AM2.5 4.0 4.2 • Go to EXPORT 2.8 12.10 MODE and press the Select button. 13.4 4.1 13.1 13 13.0 13.5 13.6 13.8 4.5 OD mmHg 3.0ID 1 ME21 ME21 ME2113: PC/ MOBILE MENU NEW .2 17.8 21 REPEAT 4.3 5.2 3.1• Navigate to TEST and press the Select button. ID02 4.6 4.6 RETURN 2.2 2.2 4.4 TEST 4.4 PAIR PAIR UNPAIR ----18/09/2017 18/09/2017 3.2 3.2 12: PRINTER 12:MENU PRINTER MENU 12.8 If Printer is not found BLUETOOTH • FOUND EXPORT or NOT FOUND EXPORT will PATIENT appear to TO MENU IDindicate the connection status. 07:37:45 AM07:37:45 AM 13.2 13 NEW OFF 740A 740A 740A PATIENT ID OFF 100 ME21 100 PRINT URN RETURNIFPRINT ID 1 ID 1 PRINTER HISTORY PATIENT ID BLUETOOTH BLUETOOTH BLUETOOTH FOUND PAIR PAIR TEST UNPAIR BLUETOOTH CONNECTION WAITING... EXPORT PRINTING...13: PC/ CONNECTION MOBILE MENU If PC/ Mobile Device CONNECTED 12.3 12.6 12.8device already exists 12.10 12.8 ME21 ID ME21 ENU TO MENU 1.17 to PC/ Mobile PATIENT BLUETOOTH SOUND 740A RETURN RETURN is1.18 not found MODE 740A BLUETOOTH OFF mmHg ID 1 If connection EXPORT 740AIcare NEW 740A BLUETOOTH EXPORT EXPORT CANCELLED DEVICE TEST REMOVED OS remove OSthe pairing (computer PATIENT ID PATIENT ID /2017 To connection): 3.3 PRINTING... TO MENU TOME21 MENU ME21 45 AM 2/100 2/100 012345 If PC/ Mobile Device 4.0 4.2 4.1 • Go to EXPORT MODE the Select button. 13.4and press 13.1 13.7 13.9 13.0 13.5 13.6 13.8 4.5 3.013.1 TEST 13: PC/ MOBILE MENU ING... is not found .2 17.8 4.3 3.1 740A 4.6 ID02 18/09/2017 • Navigate to UNPAIR. 5.3 4.4 2.3 2.3 PRINTER SEARCHING... ----EIPT PAIRED PRINTING... CONNECTION 3.218/09/2017 MENU 07:37:45 AM • Press 18/09/2017 the Select button to remove the pairing between 3.3 the ic2003.3 device and the 12: PRINTER 13.4 13.1 13.1 13.7 13.9 13.2 13 NOT FOUND FOUND 1 PATIENT ID OFF OFF 07:37:45 AM07:37:45 AM ME21 TEST REMOVED 4.5 4.5 PRINT computer. URN 100 IF PRINTER 13: PC/ MOBILE 13: PC/ MENU MOBILE MENU ID 1 17.4 17.2 17.4 17.8 17.2 17.8 PAIR PAIR HISTORY PATIENT ID ID02 BLUETOOTH BLUETOOTH CONNECTION WAITING... WAITING... TEST BLUETOOTH PAIRING EXPORTBLUETOOTHUNPAIR ID02 ME21 PRINTING... PRINTING... CONNECTED ENU PATIENT ID BLUETOOTH 740A 13.3 RETURN ---- ------ID 918.2 ---- 18.2 OD mmHg MODE NEW OFF ID DEVICE 1 BLUETOOTH740A EXPORT REMOVED EXPORT 740A CANCELLED DEVICE 740A Icare CANCELLED SOUND RECEIPT RECEIPT PATIENT ID Document name: GUI Flowchart TA031 1/100 TO MENU PATIENT ID PATIENT ID CONNECTION WAITING... WAITING... 012345 PAIRING ME21 If PC/(send) Mobile Device 3/100 3/100the To export measurement results: IF PRINTERIF PRINTER Document number: TA031-GUI BLUETOOTH BLUETOOTH is not found 3.1 CANCELLED DEVICE 740A CANCELLED CONNECTED CONNECTED 4.6DEVICE 4.3 isRevision: activated (see 12.4 12.5 and the computer connected to internet. 18/09/2017 • Make sure pairing 4.4 05- above) Pikamuutokset Icare EXPORT Icare 18/09/2017 3.2 12: PRINTERPAIRED MENU 5.4 EXPORT 07:37:45 AM • Select the ic200 device in the Icare EXPORT software. 3.3 13.1 13.1 13.7 13.9 13.2 13.3 07:37:45 AM2.5 13.4 13: PC/ M 2.5 Date: 17.8.2018 OFF OFF is connected 740A PRINT • At this pointIf Printer measurements are sent to cloud for further4.5 management with software. URN ID 1 13: PC/ MOBILE MENU Author: Tomi Lonka (Desigence) 4.6 4.6 ID02 ME21 • YouPRINTING... will also be able to set software to send measurements to cloud from the ic200 device13.3 as you take measurements. ENU 13.3 RETURNBLUETOOTH 13.2 ID OD ID 9 PAIR BACKPATIENT BLUETOOTH 2 OS 12.7 RECEIPT 12.4 PATIENT ID 12.9 12.5 SOUND 1/100 TO MENU ME21 PATIENT ID CONNECTION WAITING... 012345 2/100 12:RETURN ME21 PAIRING PAIRED PRINT PRINT WAITING... BACK NTER MENU PRINTER RETURN MENU If Printer is connectedIf Printer is connected BLUETOOTH CANCELLED DEVICE 4.0 CANCELLED 740A4.0 /100 MENU MENU 4.2RETURN 4.1 5.0 4.2 4.1740A ToTOturn offTO Bluetooth (to saveME21 batteries, pairingDEVICE is not 3.0removed): 3.0ME21 RETURN 4.4 18/09/2017 Icare012345 EXPORT 12: PRINTERPAIRED MENU 18/09/2017 • Go to BLUETOOTH and press the Select button.3.2 PAIRED 3.3 TO MENU TO MENU 07:37:45 AM 12.2 12.2 12.4 12.4 12.7 12.7 12.9 12.9 PAIR TEST UNPAIR BACK 12.6 5.5 12.5 12.5 PAIR 07:37:45 AM 740A 740A 740A 4.5 • Navigate with the Navigation 13: PC/ MOBILE MENU ME21 buttons to TURN OFF. ME21 ID 1 ME21 NEW 17.4 17.2 17.8 ID02 4.6 PRINTING... • Press the Select button to turn off Bluetooth. 13.3 18.2 ------13.2 SO HISTORY PATIENT ID13.3 BLUETOOTH BLUETOOTH PATIENT ID BLUETOOTH BLUETOOTHTURN BLUETOOTH BLUETOOTH PAIRING BLUETOOTH If PC/ Mo OS RECEIPT PATIENT ID is not fou 740A OFF mmHg ID 1 ID PAIR EXPORT EXPORT 740A ID 1 OFFBACK ERROR OFF 2/100 ME21 PAIRED PAIR PATIENT TEST TEST UNPAIR UNPAIR BACK NTER MENU SOUND PAIR PAIR 3/100 If Printer is connected IF PRINTER 13.3 BLUETOOTH PRINTING... ME21 PRINTING... ME21 ME21 ME21 ME21 ME21 ME21 CONNECTED NEW NEW 3 12.6 12.8 12.10 13.4 RETURN Icare EXPORT PAIRED 4.3 3.1 4.3 3.1 RECEIPT RECEIPT 012345 18/09/2017 PAIRED 3.3 18/09/2017 er is not found If Printer is not found 12.2 12.4 12.7 12.9 12.5 TO MENU 07:37:45 AM 740A 07:37:45 AM 740A 740A 4.5 13: PC/ MOBILE MENU OFF OFF 4.6 17.4 17.2 17.8 OFF OFF PAIRED ID02 12.8 18.2SEARCHING... ---- 12.8 ---12.3 12.3 12.6 12.6 12.8 12.8 12.10 12.10 C PAIRED PRINTING... CONNECTION 740A ID BLUETOOTH PATIENT ID TESTPATIENT BLUETOOTH FOUND 1 9 OD ID REMOVED PAIR PATIENT ID TEST UNPAIR BACK PAIR ME21 PRINT NTER MENU RETURN 3/100 IF PRINTER 1/100 13.3 If Printer is connected BLUETOOTH ME21 ME21 ME21 NEW ME21 CONNECTED TO MENU RETURN PRINTING... Icare EXPORT PRINTER SEARCHING... SEARCHING... PAIRED PAIRED PRINTING... PRINTING... CONNECTION CONNECTION er isPRINTER not found 12.2 12.4 12.7 12.9 4.4 4.4 TO MENU 12.5 TEST 3.2 3.2 12: PRINTER MENU 12: PRINTER MENU 12:MENU PRINTER MENU NOT18/09/2017 FOUND12: PRINTER NOT FOUND FOUND 1 FOUND 1 Printer ME21 If Printer isIfconnected ME21is connected TEST TEST REMOVED REMOVED 07:37:45 AM PAIRED 4.6 12.5 ID 1 12.8 12.3 12.6 ID 1 12.10 740A 12.2 12.2 12.4 12.4 12.7 12.7 12.9 12.9 12.5 12.5 BLUETOOTH BLUETOOTH TEST UNPAIR BACK PAIR OSRETURN PRINT PATIENT ID PAIR PATIENT ID ME21 ME21 ME21 ME21 ME21 PRINTING... NEW ME21 13 www.icaretonometer.com TO2/100 MENU RETURN IR PRINTER 12.4 BACK 12.4 12.5 12.5 SEARCHING... RECEIPT PAIRED PRINTING... CONNECTION er is not found TO MENU 21 PAIR PAIR TEST TEST UNPAIR UNPAIR PAIR PAIR NOT18/09/2017 FOUND FOUND 1 13: PC/BACK MOBILE BACK MENU TEST REMOVED 3.3ME21 3.3 If Printer is connected 07:37:45 AM ME21 ME21 ME21 ME21 ME21 ME21 NEW NEW

9 mHg

100 100

mmHg mmHg

7 2.4 .6

17.4

mmHg

2.6

mmHg

17.417.4 16.5

mmHg

12.612.6

TBD TBD

mmHg

17.4

mmHg mmHg

17 12.4 .6

TBD

mmHg

12.6

mmHg

17.4

mmHg

12.6

17.4 17.2 17.8

12.3

12.6

12.8

4.5 12.10

4.5

13: PC/ MOBILE MENU 13: PC/ MOBILE MENU

MONTH 2017 11.1 2017 SN FORMAT DD.03.2017 YEAR 1733RM001 hh:mm YEAR DD.MM.2017 DD.MM.2017 SW 10.2 1.00 A 17

10.3 10.3

03 DAY 03 HOURS 16.03.2017 MONTH 17:mm MONTH DD.03.2017 DD.03.2017 10.3

Icare ic200 tonometer manual

15 15 MINUTES MINUTES 17:15 17:15

ENGLISH

15 16 MINUTES 16 DAY 17:15 DAY 16.03.2017 The following messages may appear on the display screen: 16.03.2017

GHTNESS

ERROR AND INFO MESSAGES MESSAGE DESCRIPTION

8.0 14: ERRORs & ALERTs

RTs GHTNESS

GHTNESS GHTNESS

R GHTNESS

GHTNESS E GHTNESS GHTNESS

8.0

CHANGE

14.3 14: ERRORs & ALERTs

14.1 14.0 14.0 14.6

8.0

CHANGE 8.1

8.2 ALIGNMENT ERROR

CHANGE CHANGE CHANGE 8.0 8.1 8.2

14.4 14.1 14.1

14.9 14.2

14.5

REPEAT 8.3

TOO FAR 8.1 CHANGE 8.2 CHANGE 8.3 8.4

PRINTER ERROR CHANGE 8.2 CONNECTION8.3 TOO FAR RESTORED 8.4 CHANGE TOO FAR

GHTNESS GHTNESS 14.6 GHTNESS 14.10

R GHTNESS GHTNESS

14.7 14.7

TOO NEAR

8.3 8.4

CONNECTION REPEAT CONNECTION RESTORED 14.8 14.10 14.12 14.10 14.9

ON D GHTNESS 13.8 ON

14.11

14.12 14.12 13.8

13.9 14.13 13.8

SERVICE RESTORED

8.4

CONNECTION Sensor ERROR calibration PRINTER ERROR UNPAIR 740A

PAIRING Sensor ERROR calibration Sensor calibration UNPAIR 740A

NOT FOUND PAIRING EXPORT CANCELLED SERVICE

13.9

UNPAIR 740A 13.8

NOT FOUND PAIRING 740A CANCELLED

13.9

UNPAIR 740A

11.0

DATE 16.03.2017

INFO

TIME 17:15

9.0

10.0

9.1

10.1

Turn the tonometer 1733RM001 OFF by pressing the Select button. Replace the batteries. 11.0

11.1

EN DMY DATE LANGUAGE LANGUAGE FORMAT 16.03.2017 ENGLISH The probe was not perpendicular to the cornea or the ENGLISH DD.MM.YYYY 10.0 9.0 14.3 14.2 probe hit an eyelid or eyelashes. 9.1

SN 1733RM001 24 H INFO TIME 1733RM001 FORMAT SW 17:15 Ensure the eye is open and the probe points towards the center of the cornea and hh:mm 1.00 A 11.0

is perpendicular 11.1 to the surface of the cornea.

10.1 10.2

SN 1733RM001 EN DMY 24 H INFO DATE TIME LANGUAGE FI 2017 17 CHANGE 1733RM001 LANGUAGE FORMATor did not make clean FORMAT SW 16.03.2017 17:15 ENGLISH The probe did not move properly Measure again or change the probe. To clear error messages, press the Measure CHANGE KIELI YEAR HOURS ENGLISH DD.MM.YYYY hh:mm 1.00 A 10.0 11.0 9.0 contact button, after which the measurement can be repeated. SOUMI with the cornea. DD.MM.2017 17:mm 10.1 9.1 11.1 14.5 14.6 SN 10.2 9.2 10.3 9.3 1733RM001 EN DMY 24 H 14.3 14.2 INFO DATE TIME LANGUAGE FI 2017 17 14.3 14.2 SV 03 15 1733RM001 LANGUAGE FORMAT FORMAT SW 16.03.2017 17:15 ENGLISH The probe did not move. Change the probe. The probe was twisted or otherwise inserted incorrectly. KIELI YEAR HOURS ENGLISH DD.MM.YYYY hh:mm 1.00 A SPRÅK TOO NEAR MONTH MINUTES REPEAT To clear error messages, press the Measure button, after which the measurement SOUMI DD.MM.2017 17:mm 10.1 9.1 11.1 CHANGE SVENSKA DD.03.2017 17:15 SN error keeps recurring, change also the probe base as 10.2 9.2 CHANGE CHANGE can be repeated. If the 10.3 9.3 1733RM001 EN DMY 24 H CHANGE 14.3 FI 2017 17instructed in Replacing the probe base. 9.4 14.5 14.6 SV 03 15 LANGUAGE FORMAT FORMAT SW 14.8 14.9 14.5 14.6the eye. The Adjust correct measurement distance about 5 mm. The measurement was taken KIELI YEAR HOURS DEprobe did not touch 16 ENGLISH DD.MM.YYYY hh:mm 1.00 A SPRÅK MONTH MINUTES SOUMI DD.MM.2017 17:mm from too far away. CHANGE SPRACHE DAY SVENSKA DD.03.2017 17:15 10.2 9.2 10.3 9.3 DEUTSCH 16.03.2017 CONNECTION PRINTER TOO NEAR REPEAT ERROR ERROR FI 2017 17 9.4 TOO NEAR REPEAT 14.6 SV 03 15 Too Adjust correct measurement distance about 5 mm. The measurement was taken KIELI YEAR DEshort measurement distance 16 between the probe and HOURS SPRÅK MONTH MINUTES SOUMI DD.MM.2017 17:mm the cornea. from too close. To clear error messages, press the Measure button, after which the 14.11 SPRACHE DAY SVENSKA DD.03.2017 17:15 14.8 14.9 10.3 9.3 measurement can be repeated. DEUTSCH 16.03.2017 14.8 14.9 REPEAT 9.2

9.4

Internal error detected. DE CONNECTION

SPRÅK CONNECTION ERROR SPRACHE SVENSKA ERROR 14.9 DEUTSCH

03 PRINTER 16 PRINTER MONTH ERROR ERROR DAY DD.03.2017

Turn the tonometer OFF by pressing the Select button. Contact the seller to

MINUTES arrange sending the device for service. 17:15

16.03.2017 9.4

14.11 14.13 14.11

Printer loses power during connection or &itALERTs is OFF. PRINTER DE 1614: ERRORs

SPRACHE DEUTSCH

ERROR SERVICE

Acknowledge with the Select button. Look for solution from the printer, not the ic200.

DAY 16.03.2017 14.0

14: ERRORs & ALERTs The pass key is incorrect or pairing is removed from the 14.13 computer end when the user tries to connect from ic200. CHANGE

For incorrect pass key acknowledge with the Select button. For partially removed pairing remove the pairing from both the ic200 and computer. Renew the pairing.

14.13

SERVICE SERVICE

14.0

14: ALERTs testing The Icare EXPORT software was not active& when 14.1ERRORs 14.2 the connection. CHANGE 14.0

CHANGE

Displayed for 214.3seconds. Run the Icare EXPORT software on the computer and test again.

14: ALERTstesting the The Bluetooth connection was not active &when 14.1ERRORs 14.2 connection. 14.5 14.4 CHANGE 14.0

CHANGE

The connection to the computer14.1 is lost.

TOO FAR

14.4

CHANGE

14.5

14.7

CHANGE

14.8

The Select button was pressed to14.1 exit the pairing on the 14.2 TOO FAR EXPORT MODE. 14.5 14.4 CONNECTION RESTORED

PAIRING CANCELLED 14.7 14.10 14.4

www.icaretonometer.com

CHANGE

TOO FAR

14.10

14.8 14.11 14.5

CONNECTION RESTORED

Displayed for 214.3seconds. Make sure the Bluetooth is ON also at the computer end. 14.6

TOO FAR CONNECTION

CHANGE

In 2 seconds the returns to the screen previously used. Try to reconnect. 14.3 ic200 TOO NEAR REPEAT 14.6

CHANGE

In 2 seconds the returns back to the PAIR NEW screen. 14.3 ic200 REPEAT

CONNECTION ERROR CHANGE

14.6

PRINTER ERROR CHANGE

14.9

TOO NEAR

CONNECTION ERROR

14.11

CHANGE 14.9

TOO NEAR

14.8

14.7

CHANGE

14.2

CONNECTION PAIRING LOST CANCELLED 13.9

Prepare to replace the batteries.

10.0

9.0

The batteries are empty.

8.1

14.4 GHTNESS ON 14.4 GHTNESS 14.7 GHTNESS 14.3 GHTNESS E

Battery charge is low.

ACTIONS

LANGUAGE ENGLISH

14.0

GHTNESS 14: ERRORs & ALERTs GHTNESS

MINUTES 17 17 SW 17:15 HOURS 1.00 A HOURS 17:mm 17:mm

REPEAT 14.6

PRINTER ERROR

14.9

TOO NEAR

REPEAT

CONNECTION

PRINTER

2.2

Revision: 04 1.8 1.7 Date: 11.14.2017 ID 9 Author: Tomi Lonka (Desigence) 1.8

ID 9

1.0

1.9OD 1.9

OS ID 9ID 9 EYE

ID 9

MEASUREMENT FLOW CHART

1.101.10

ID 9ID 9

23 23.9.9

1.9

ID 9

1.0 0.2

17.6

16/03/2017 OD mmHg LOAD 16:36:10 MEASURE MEASURE MEASURE 1.10 ID 9

23.9 1.5

ID 9

1.2 1.2 0.3

1.2

OD ID 9 LOAD LOAD

20.8 1.8

ID 9

OD mmHg 1.59 ID ID 9

1.5 ID1.5 9

1.3

ID 9 OD OS LoadOS Probe EYE EYE OD OS OD OS OD EYE OD OS OS LOAD EYE EYE EYE OD mmHg

20.8

ID 9

1.6 ID1.12 91.6

1.7

ID 9

ID 9 1.89 ID ID ID 99

17.6 17.6

1.13

16.6 23 23.8.8

ID 9

ID 9 ID 9

23 23.9.8 8 17.6 17.6 17.6 .4 OD mmHg

mmHg

OD mmHg OD mmHg 1.11 OD mmHg ID 9 OD mmHg

20 16.8.5 23.9.9 23 5 23 17.9.4

ID 9

17.4

IF PRINTER CONNECTED

mmHg

OD mmHg mmHg 1.12 OD mmHg ID 9 OD mmHg

16.5 16.8.5 20 .8 20 5 20.8 ID 9 ID 9

OD mmHg

ID 9ID 9 12.0

mmHg mmHg ODOD

16.6

OD mmHg OD mmHg OD mmHg 1.13 ID 9 OD mmHg

PRINTING... RECEIPT

17.6 16.5.5 16.516 16.6.6 16.6 16

1.13

1.18

17.4 17.6 17.6 ID 9

ID 9

OD mmHg

1.15

23.8

12.

BACK 2/100

12.3 IF PRINTER IF PRINTER IF PRINTER CONNECTED CONNECTED CONNECTED PRINTER

2.5

PRINTER NOT FOUND PRINTING... PRINTING... RECEIPT RECEIPT PRINT RETURN RETURN PRINT RETURN ME21 TO MENU TO MENU ME21 TO MENU

3.3 3.3

NOT FOUND SEARCHING... PRINTING... FOUND 1 RECEIPT PRINT ME21 12.4 12.5

PAI ME B

PAIR PRINTING...PRINTING... ME21 PRINTING... RECEIPT RECEIPT RECEIPT 12.2

12: PRINTER MENU

12.6

ID 9

16.6

IfmmHg Printer is not found ODMENU 12: PRINTER 12: PRINTER MENU 12: PRINTER MENU 12.8

ID 9

CONNECTED

12.0

12.112.1

PRINT ME21

ID 9

OD mmHg

1.14

3/100

12.8

ID 9

17.6

1.18

ID 9 www.icaretonometer.com 1.13

PAIR NEW

12.4

16.5

OD mmHg OD mmHg OD mmHg OD mmHg OD mmHg OD mmHg 1.15 IF PRINTER ID 9

23.9

OD mmHg

REPEAT

1.17 OD mmHg

ID 9 BACK 2/100

20.8

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12: PRINTER MENU

If Printer is not 2.4 found

18/09/2017 07:37:45 AM

OD mmHg

REPEAT

ID 9

2.3 18/09/2017 18/09/2017 07:37:45 AM 07:37:45 AM

1.181.18

Tonometer OFF by pressing the Select button 12.1 >3 seconds

IF PRINTER 12.2 CONNECTED

REPEAT REPEAT

1.171.17 12.1

mmHg

OD mmHg

3/100 IF PRINTER IF PRINTER CONNECTED OS CONNECTED OS OS 2/100 2/100 2.5 2/100 12.012.0

OD mmHg

1.11

17.4 1.16

ID 9

mmHg mmHg OD mmHg 2.5 2.5

PRINT ME21

3.1 3.1

3.2 3.2 12.

12.6.6 12.6 12

17 .4.4 .6 1717

BACK BACK 2/100 2/100

PRINTING... RECEIPT

17.4 17.2 17.8

17 17.4.4

1.10 1.161.16

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2.2 12: PRINTER MENU 18/09/2017 18.218/09/2017 ------18/09/2017 07:37:45 AM 07:37:45 AM 07:37:45 AM

2.3

16 16.5.5

PRINT ME21

ID 9 OD mmHg

2/100

OD ID 9 OD ID 9 2.39 OS ID OD 1/100 OD OD 18/09/2017 1/100 1/100 EYE EYE 07:37:45 AM

ODOD mmHg mmHg2.3

mmHg mmHg 2.4 2.4 2.4 IF PRINTER CONNECTED

3.0 3.0

07:37:45 AM

18/09/2017 1.6 18/09/2017 07:37:45 ID 9 AM 07:37:45 AM 07:37:45 AM OS

ID 9ID 9

16 16.5.5

OD mmHg

OD mmHg Successful 12.0 measurement

EYE

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17.6

1.15

16 16.6.6 12.6 17.4.4 17.4 17

1.8

ID 9

2.4

1.15

ID 9

17 17.6.6

OS EYE ODOD mmHg mmHg2.2

PRI ME

OSRETURN TO MENU PRINT ME21

1/100

HISTORY OD mmHg 18/09/2017

OD mmHg OD mmHg 2.1 18/09/2017

2.2

16.5 16.6

16.5

ID 9

ID 9 1.12

ID 9ID 9

OS OS OSOD OD OS OD OD OS OD EYE OS OD mmHg OD OD mmHg EYE OS EYE EYE EYE EYE mmHg mmHg OD mmHg OD mmHg

ID 9

1.10 1.14

ID 9 1.11 ID 9 1.16

1.6

OD mmHg

ID 9

1.131.13

17.4

HISTORY HISTORY LOAD mmHg 2.2 mmHg

2.1 1.5

ID 9

1.11

OD mmHg

1.10 ID 9

1.4

EYE

OD ID 9

16 16.5.5

ID 9

HISTORY mmHg BACK OD 2/100 18/09/2017 RETURN 07:37:45 AM TO MENU

IF PRI CONNE

IF PRINTER CONNECTED

2.5

2.0

ODpressed the OSSelect button, pressing of the This is displayed if you LOAD 1.10 EYE ID 9 would lead Measure button you directly to Load Probe 1.121.12 ID 9ID 9 OS OD OS OD OD EYE OS LOAD EYE EYE 1.6 ID 9 OD mmHg ODOD mmHg mmHg2.1

1.151.15

1.9 1.8 1.8 ID 9 1.13

1.99 ID ID 9

1.2

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3/100

2.1

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Ready to measure 1.14 and1.14 eye side selection

1.12

EYE

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2.5

20 20.8.8

1.1

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3/100

MEASURE ID 9ID 9

1.111.11

17.6

OD mmHg

LOAD

OS OD S

ID 9

1.2

18/09/2017 07:37:45 AM

2.4

ODOD mmHg mmHg 2.4 OS OD Turn Tonometer ON by pressing EYE the Select or Measure button

1.9

EYE 1.11

2.0

BACK BACK 2/100 ENGLISH2/100

18/09/2017 07:37:45 AM

2.3

1.0

MEASURE

2/100

2/100 2.3 manual Icare ic200 tonometer

ODOD mmHg mmHg

ID 9

17 17.6.6

0.1

12.6

mmHg

Document name: GUI EYE EYE Flowchart TA031EYE OD Document OS OD OS OD number: TA031-GUI EYE EYE EYE

mmHg

2.4 2.4

mmHg

mmHg mmHg

12.6

18/09/2017 07:37:45 AM

1.6

ID 9

mmHg mmHg

1.5

ID 9

12.2 12.2 12.8

PRINTER NOT FOUND

If Printer is not found is not found If Printer If Printer is not found IF PRINTER CONNECTED 12.3 12.8 12.8 12.4 12.3 12.8 12.0

17.4

PAIRED ME21 12.3 12.2

PAIR PRINTING... PAIR NEW TEST NEW

PAIR NEW

12.8

PAIR ME

If Printer If Printer 12.4 12.4

PRINTI SEARCHING... TES PAIR 1 FOUND NEW

15 12.3

12.5

12.6 12.6

Icare ic200 tonometer manual

ENGLISH

ACCESSORIES, DETACHABLE PARTS AND OTHER SUPPLIES SKU 104 540 559 527 7169 619 565 566 567 568 568A 568B 568C 548 577E 544B

PRODUCT DESCRIPTION Probe Icare TP01, 100 pcs/box Probe base Wrist strap with lock Aluminum case, Icare ic200 Battery cover & screw IOP pad, Icare ic200 Silicone grip white Silicone grip green Silicone grip dark gray Silicone grip blue Silicone grip pink Silicone grip light pink Silicone grip yellow Screwdriver USB memory stick, Icare ic200 Probe base cover, Icare ic200

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

DIMENSIONS 53 x 109 x 36 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 45 x 35 x 113 mm 45 x 35 x 113 mm 45 x 35 x 113 mm 45 x 35 x 113 mm 45 x 35 x 113 mm 45 x 35 x 113 mm 16 x 90 mm 98 x 11 x 93 mm 19 x 11 mm

TECHNICAL INFORMATION Type: TA031 Dimensions: 43 mm (W) x 104 mm (H) x 214 mm (L). Weight: 165 g (without batteries) Power supply: 4 x AA non-rechargeable batteries, 1.5 V alkaline LR6. Measurement range: 7-50 mmHg Accuracy: ±1.2 mm Hg (≤20 mmHg) and ±2.2 mm Hg (>20 mmHg). Repeatability (coefficient of variation): < 8 %. Accuracy of display: 0.1 mmHg. Display unit: Millimeters of mercury (mmHg). Mode of operation: continuous.

Operation environment: Temperature: +10 °C to +35 °C Relative humidity: 30 % to 90 % Atmospheric pressure: 800 hPa to 1,060 hPa

Storage environment: Temperature: -10 °C to +55 °C Relative humidity: 10 % to 95 % Atmospheric pressure: 700 hPa to 1,060 hPa

Transport environment: Temperature: -40 °C to +70 °C Relative humidity: 10 % to 95 % Atmospheric pressure: 500 hPa-1,060 hPa

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.

IT-NETWORK SPECIFICATIONS WARNING Connection of the ic200 tonometer to IT networks including other equipment could result in previously unidentified risks to patients, operators, or third parties. WARNING The responsible organization should identify, analyze, evaluate, and control any additional risks resulting from the ic200 tonometer connected to IT networks including other equipment. PRECAUTION Changes to the IT network could introduce new risks requiring additional analysis by the responsible organization. The changes include: • changes in the IT-network configuration • connection of additional items to the IT-network • disconnecting items from the IT-network • update or upgrade of equipment connected to the IT-network To transfer the measurement data from the ic200 tonometer to a host device, the tonometer must be connected to responsible organizations IT Network over Bluetooth. The ic200 tonometer is designed to work stand-alone without the Bluetooth connection. The ic200 tonometer is designed such that network failures will not prevent the ic200 tonometer from working normally. Required characteristics of the IT-network: Printer: Bluetooth® Classic, ESC/POS communication protocol. Computer: Bluetooth® 4.0 (or greater) Low Energy support. Connection is secured by link authentication. Intended Information Flow: Measurement data is collected by the ic200 Tonometer. This data is sent via Bluetooth connection either to a wireless printer (Bluetooth Classic), or to the computer (Bluetooth Low Energy, BLE) which has the Icare Export application installed. The Icare Export will transfer the data into the Icare CLINIC software. Operators can then access the data by using the Icare CLINIC software with a web browser in an internet connected device. Potential Hazardous situations resulting from the failure of the IT-network: • If the Bluetooth connection is lost during data transfer, no data is lost from the device. The measurement data can still be found from the device history and transferred once the connection is re-established. • Failure or misconfiguration of the IT-network may result in data not being transferred causing inconvenience to the operators.

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Icare ic200 tonometer manual

ENGLISH

PERFORMANCE DATA The performance of the device is determined based on bench testing in comparison to the predicate device ic100 (similar technology, energy source, materials, probe), which has been tested to conform to the requirements of American National Standard ANSI Z80.10-2014 and International Standard ISO 8612 for tonometers. The study was performed at the Manipal University, India. In the study, 151 patients were measured in sitting position. The mean paired difference and standard deviation (Icare-Goldmann) were -0.48 mmHg and 1.68 mmHg.

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 and the probe base. If there is reason to believe servicing of the device is necessary, contact qualified service personnel or your local Icare representative. PRECAUTION Keep the tonometer out of reach of children. The probe base, battery compartment cover, screws, collar and probes are small objects and may be accidentally swallowed.

REPLACING THE PROBE BASE Change the probe base after six months. If the error message Change is shown on the display screen more than two times in a row after changing the probe, replace the probe base before resuming use of the device. Instructions for replacing the probe base: • Turn power off from the tonometer. • By hand, unscrew the probe base collar and place it in a safe location. • Pull the probe base out of the tonometer using thumb and fingers. • Insert a new probe base into the tonometer. • Screw the collar down until it firmly locks the probe base.

CLEANING THE TONOMETER WARNING Never immerse the Icare tonometer in liquid. Do not spray, pour or spill liquid onto the Icare tonometer, its accessories, connectors, switches or openings in the chassis. Remove any liquid appearing on the surface of the tonometer immediately. To help avoid possible cross-contamination and infection, clean the tonometer’s forehead support after each patient with a disinfectant. The outer surfaces of the Icare ic200 tonometer may be safely cleaned with the following liquids: • 70-100 % isopropyl alcohol • Mild soap solution • 95 % Pursept solution Instructions for cleaning the tonometer’s surface: • Turn the power off. • Dampen a soft cloth with one of the permitted cleaning fluids. • Lightly wipe the surfaces of the tonometer. • Remove residual fluid using a soft, dry cloth.

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Icare ic200 tonometer manual

ENGLISH

RETURNING THE ICARE TONOMETER FOR SERVICING OR 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 any accessories with the tonometer. Use a suitable cardboard or similar box with the appropriate packaging material to protect the device during shipment. Return the device using any shipping method that includes proof of dispatch and delivery.

PERIODIC SAFETY CHECKS Every 24 months we recommend that the tonometer is checked for correct function as well as visually inspected for mechanical damage and legibility of the safety labels. Applicable in Germany only: Messtechnische Kontrolle nach MPG (Medizinproduktegesetz) alle 24 Monate.

SYMBOLS LOT

Caution

Manufacturing date

Consult operating instructions

Lot number

STERILE R

Serial number

Single use only

Sterilized using irradiation

Keep dry

This product meets the power requirements for a Class 1 LED product to IEC/EN 60825-1 (2001) under normal operating conditions and those of single fault failure.

Use by

rotected from touch by fingers and objects P greater than 12 millimeters. Protected from water spray from any direction.

Non-ionizing radiation

BF-type device Manufacturer

Rx Only

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

Do not dispose of this product with household waste. Send to appropriate facility for recovery and recycling. EU WEEE (European Union Directive for Waste of Electronic and Electrical Equipment).

T echnical conformity mark and certification number of the Ministry of Internal Affairs and Communications of Japan (MIC).

95%

55°C -10°C

10%

1060hPa

700hPa

95%

70°C

Storage environment

1060hPa

Transport environment -40°C

Temperature limits

10%

Humidity limits

www.icaretonometer.com

500hPa

Atmospheric pressure limits

Icare ic200 tonometer manual

ENGLISH

INFORMATION TO THE USER REGARDING THE RADIO COMMUNICATION PART OF THE DEVICE WARNING Changes or modifications not expressly approved by Icare Finland Oy could void the user’s authority to operate the equipment. Icare ic200 (TA031) device contains a Bluetooth transmitter working at frequencies between 2.402 GHz and 2.480 GHz. Due to the limited size available on the device, many of the relevant approval markings are found in this document. Bluetooth Module Information: Item Bluetooth Module Communication Radio Frequency (RF) Range Output Power Antenna Gain Effective Radiated Power Transmitting Distance

Specification RN4678 Bluetooth 4.2 Dual Mode Classic (BR/EDR) and Low Energy (LE) 2.402 GHz – 2.480 GHz < 2.5 mW (4 dBm), Class 2 1.63 dBi < 2.2 mW (3.4dBm) 10 meters (30 feet)

The Device Contains a module with: FCC ID: A8TBM78ABCDEFGH IC: 12246A-BM78SPPS5M2 MIC: 202-SMD070 Statement of Compliance: This device complies with Part 15 of the FCC rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, 2. This device must accept any interference received, including interference that may cause undesired operation Changes or modifications not expressly approved by Icare Finland Oy could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. T his Product operates in the unlicensed ISM band at 2.4GHz. In case this Product is used around the other wireless devices including microwave and wireless LAN, which operate same frequency band of this Product, there is a possibility that interference occurs between this Product and such other devices. If such interference occurs, please stop the operation of other devices or relocate this Product before using this Product or do not use this product around the other wireless devices The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Icare Finland Oy is under license. Other trademarks and trade names are those of their respective owners.

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Icare ic200 tonometer manual

ENGLISH

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, transducers and cables 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. PRECAUTION The measurement method of the Icare ic200 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. Icare ic200 (TA031) 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 following tables. Portable and mobile RF communications equipment can affect Icare ic200 (TA031) Tonometer. The Essential Performance of the Icare ic200 (TA031) tonometer is to measure the Intraocular Pressure (IOP) and to display the measurement results.

GUIDANCE AND MANUFACTURER’S DECLARATION IEC 60601-1-2:2014; EDITION 4.0 - ELECTROMAGNETIC EMISSIONS Icare ic200 (TA031) is intended for use in a professional healthcare environment with electromagnetic characteristics specified below. The user of the Icare ic200 Tonometer (TA031) should assure that it is used in such an environment. RF emissions CISPR 11

Group 1

Icare ic200 (TA031) 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 ic200 (TA031) 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 IEC 61000-3-2

NOT APPLICABLE

Voltage fluctuations flickering emissions IEC 61000-3-3

NOT APPLICABLE

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