USER`S AND M AINTENANCE M ANUAL
Contents
1. Serial number e Use by lt date gt ro 8 Ble D www icaretonometer com LOT STERILE R x G e Keep dry e Manufacturing date Lot number e Sterilized using irradiation e Stand by e Do not discard this product with other household type waste e Send to appropriate facility for recovery and recycling e EU WEEE European Union Directive for Waste of Electronic and Electrical Equipment 142. case you end up taking multiple measurements for some reason the eye details can be incorrect and must be fixed See Icare LINK user manual www icaretonometer com Instruction for the patient Switch on the unit load the probe Go in front of a wall mirror Take the tonometer in your hand with the white main button pointing upwards Move the tonometer sideways toward your eye so that you see in the mirror the white tip of the probe in front of the black pupil Move the tonometer closer so that the forehead and cheek supports touch the skin Check that the white tip of the probe is seen in front of the center of the cornea Turn the tonometer from the sideway position so that the tonometer with the loaded probe points straight to the center of the cornea pupil Open your eyes wide and try not to blink your eye while measuring Press the measurement button once You will get the final result after the probe touched you eye for six times and after one long beep In automatic mode the six interim measurements are taken in sequence A new measurement needs to be taken if REPEAT ERROR LED is displayed for example if the probe made contact with the eyelid 10 Icare tonometer ONE manual English CLEANING AND DISINFECTION The forehead and cheek supports and the eye support must be cleaned for each new patient with disinfectant for example 70 alcohol solution using wipe Do not immerse the tonometer in water or other l
3. inch 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 pupil The way you take measurements depends on the chosen mode In normal mode a value is shown briefly after each successful measurement When the six measurements in sequence are completed and the measurement valid the final value of IOP is displayed If there is too much variation between the measurements the REPEAT ERROR LED is displayed and the measurement needs to be performed again The device stores the quality of the measurement in its internal memory which is only accessible by downloading to a PC using the Icare LINK software A new measurement needs to be taken if REPEAT ERROR LED is displayed for example if the probe made contact with the eyelid Encountering unusual values for example over 22 mmHg or below 8 mmHg The tonometer s internal memory stores the time and date of a measurement the measurement result and the quality level of the measurement This information can be uploaded to a PC through a USB cable using Icare LINK software If a patient does not have the software the tonometer is taken to a health care professional who can transfer the data NOTE When using Icare LINK software it assumes by default that the first accepted measurement is for the right eye and the second accepted measurement is for the left eye In
4. 1 ranges 5 7 mmHg 7 10 mmHg 10 14 mmHg 14 18 mmHg 18 21 mmHg 21 24 mmHg 24 27 mmHg 27 30 mmHg 30 35 mmHg 35 40 mmHg 40 50 mmHg SETTING UP THE TONOMETER BEFORE TAKING MEASUREMENTS Before taking measurements your tonometer the measurement position must be adjusted correctly by health care professional Set up includes e Choosing a measurement mode e Adjustment of the measurement position e Loading the probe before each measurement CHOOSING A MEASUREMENT MODE The device can operate in two modes Normal e Normal mode is used to take individual measurements one at a time The measurement button must be pressed once to initiate each of the six measurements to obtain final IOP reading Normal mode is generally used when measurements are taken by someone other than the patient Automatic e Automatic mode is especially useful in self tonometry In automatic mode a single press of the measurement button initiates the measurement function and the tonometer takes six measurements automatically to obtain final IOP reading A NOTE Device is designed to perform six subsequent movements of probe to cornea measurements after which the device calculates the final IOP range The final IOP range is displayed on device LED panel To change the measurement mode 1 Turn on the tonometer 2 Inserta straight pin into the mode switch hole on the side of the tonometer Mode switch hole Measurement mode switch 3 Push the switch w
5. A CAUTION Federal US law restricts this device to sale by or on the order of a physician or properly licensed practitioner e 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 dealer e 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 e Never open the casing of the tonometer except for the battery compartment or to change the probe base e Never use the tonometer in wet or damp conditions nor allow the tonometer to get wet e 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 e Do not use the device near inflammable substances including flammable anesthetic agents Certain microbiological agents for example bacteria can be transmitted from the forehead eye or cheek support To avoid this the forehead and cheek support and eye piece must be cleaned for each new patient with disinfectant for example an alcohol solution e The tonometer conforms to EMC requirements IEC 60601 1 2 but interference may occur in it if used near lt 1m a device such as a cellular phone causing high intensity electromagnetic emissions Although the tonomete
6. ENGLISH care EEEETEIEIE ONE USER S AND MAINTENANCE MANUAL Icare tonometer ONE manual English Icare ONE Model TA02 INSTRUCTION MANUAL v1 12 01 14 EN A 0044 This device complies with Medical Device Directive 93 42 EEC Canadian Medical Device Regulations Copyright 2012 Icare Finland Oy Made in Finland Icare Finland Oy yritie 22 FI 01510 Vantaa Finland Tel 358 9 8775 1150 Fax 358 9 728 6670 www icarefinland com info icarefinland com TABLE OF CONTESTS Table of CONTESTS IRI DRE A ee nen Cen RR IE RR II RI RR ee re 2 Safety WN SUF UNG CIN morire poimaine dia p n rata ina cabine dia auf neant aie e nai e vse nr i illa uta lieu simi i i nu ist 2 Indications TDF IS Eaton ema lia mata da mata mata aa tata atata ma ta aa aaa tau aaa 3 E je je Bote aha gel a ce iale ae NS IRENE RER RR RR PPR RR E IRI RR ANR RR PI RARI RE IRI NE IRINA PERIE TI INT INN OR INI PN RI E NR IVI 4 ip FURS 5 Lo RIP IRI PORN IRINA ON OI PI a pele ae E PI e e ae aia ep ilps na pe E e ae ei a aly ee i a e daly eae ete E Poeta 4 Package COnNtents ennen TRI CE RR ERORI REC RI 0 RR RR EN RP MIRI IN RR RER RI E RR MRI RDI RECE PIE SPRE ECE NI RISC MIINE AER RR N a INN RER RR 4 Turnin Ne device ON ie cama pi alai i aa ri a af ar dn sa i a ara ri ia i ia dat 5 Setting up the tonometer before taking measurements sea esuate aaea oaia tame aaa ie mea ea adie a dle dala iai ea aa 80 ai pl ea dar ta aa ai aia aie sara da 6 Choosing
7. a measurement ModE RR RR RR RI RR RR RO RI RR N RR RI II N NINO RR RE III RR RR RR RR RI NR PRR RI IRI IP IRI RR 6 Adjusting the measurement DOSIRIIOFI ceasca als do limes a i iun aul fa este ionii a dala iai i cd all aa 6 Loading the OS i miar ca acea mac aaa nica a aa a i ca ua a a usa nu at a dau ini na nn at at bg daia e ta 7 Measunne intraocular Pressure ri aranera E PI RI RR RR ROI e RI RR EP RR NE O RR N PRR RR RIN A NE IN RANI NR RAE RONI 8 Patient Use MMStrUCtIONS vis coaie tite da bca i n i ra dn n 5 a nl ia aa 80 a a n al Sa E atac 9 Eirormessages SMA Ne AOS cier ERROR ORE RER ERORI RER RE RD RR PR RN RI RR RR IE E RER IER RR N N 10 Differences between professional user and the patient using the Icare ONE Tonometer eee nana 10 Cleaning and disinfection PRPRREDE PRR PRIME RE RR RI RR RIN e PRR EP OR PR IE ROI PAR OR PR Ie n RU PR EI PRR IA 11 Changing the Dei EREI IRIS eta ital a li al lt tt i a aa aa d ca a tc aaa aaa aa tat a it la et a 11 Service O PO GEICIRI E 6 ee ee im ea ni mea dala i i aa ci N i n ata a a i te lit ii ia ec a tal 12 Spare pan Sio oaste to maus asta E E E ea pia a atat ma dat pia atat pa a i pal 12 TecHnicakand performance data merer aoaea EEA EE EEEE E E A EA 12 Glinicalpertormance CIEL ie es eines ae A E EAE EEE E E A EEE EEE EEE EERE E E AREE AEE 13 SYMBOLS 99 O RI RR NR RR RR A ERE RN NI EEE E get E N RR E EEE EE EE E E 14 SAFETY INSTRUCTIONS N saune The tonometer must not come into contact with the pa
8. button once You will get the final result after the probe touched you eye for six times and after one long beep In automatic mode the six interim measurements are taken in sequence A CAUTION Always perform measurement on RIGHT eye first followed by LEFT eye Complete the RIGHT eye measurement sequence before changing to the LEFT eye www icaretonometer com English Icare tonometer ONE manual English A new measurement needs to be taken if e REPEAT ERROR LED is displayed for example if the probe made contact with the eyelid e Encountering unusual values for example over 22 mmHg or below 8 mmHg ERROR MESSAGES AND INDICATORS Icare Tonometer ONE display panel shows the following LEDs LED Cs State Description and Action PROBE BLUE blinking Load probe oE eo OOO CLEAN RED lit Clean or change the probe base DIFFERENCES BETWEEN PROFESSIONAL USER AND THE PATIENT USING THE ICARE ONE TONOMETER Instructions for the health care professional Check that the tonometer is set up correctly by a doctor or a nurse The patient should relax and look straight ahead at a specific point while keeping eyes wide open Bring the tonometer near the eye Move the tonometer closer so that the forehead and cheek support touch the skin Check that the white tip of the probe is seen in front of the center of the cornea pupil The distance from the tip of the probe to the center of the cornea must be 4 8 mm 5 32 5 16
9. ent Temperature 10 C to 35 C Relative humidity 30 to 90 Atmospheric pressure 800 hPa 1060 hPa Storage environment Temperature 10 C to 55 C Relative humidity 10 to 95 Atmospheric pressure 700 hPa 1060 hPa e Transport environment Temperature 40 C to 70 C Relative humidity 10 to 95 Atmospheric pressure 500 hPa 1060 hPa CLINICAL PERFORMANCE DATA Performance data is obtained from a clinical study performed according to ANSI Z80 and ISO 8612 for tonometers The mean of paired difference Goldmann lcare ONE tonometer were 0 6 lt 16 mmHg 0 1 gt 16 lt 23 1 0 gt 23 0 8 and and standard deviation is 3 1 Bland Altman plot for IOP values of Goldmann tonometer vs Icare One tonometer AQ 4040404 E 4O Coon 0 004440 9 44 4040 mee a e o o e e eee Difference IOP One IOP GAT Mean IOP GAT IOP ONE Frequency Count 999 AAA EENG 0604 ttt 5 FHKE Scatterplot of IOP values of test tonometer against the IOP values of Goldmann reference tonometer With regression line and 95 confidence intervals IOP lcare One IOP_ONE 0 00077190 1 0290 I0P GAT 0 0 20 30 40 50 60 70 IOP Goldmann Frequency Cont AAA EEE 6064 8 5 HH e 13 www icaretonometer com Icare tonometer ONE manual English SYMBOLS e Caution See operating instructions for more information BF type device e Single use disposable
10. iquid If the tonometer displays a CLEAN error CLEAN LED the probe base see Figure below may be dirty or dusty To clean the probe base first unscrew the probe base off the tonometer Carefully inject isopropyl alcohol rubbing alcohol through the top of the probe base Dry the probe base by injecting air into the probe base and drying the part gently If it is not possible to clean the probe base then replace it with a new one Probe base le Tonometer probe base Probe base Tonometer probe base unscrewed CHANGING THE BATTERIES Lift the silicone lid that protects the USB port and keeps the battery compartment cover in place Open the battery compartment cover by pressing the silicone lid slightly and sliding the battery compartment cover as shown in figure Battery compartment cover Silicone lid Opening the silicone lid and battery cover Insert two CR123A lithium batteries in the correct order end upwards as shown in figure Close the cover firmly and press the silicone lid in place to cover the USB port A NOTE Make sure you use batteries with built in PTC protection For Example Energizer Lithium Photo 123 3V CR123A 11 www icaretonometer com Icare tonometer ONE manual English Inserting new batteries SERVICE PROCEDURES Replace the batteries when the device indicates low battery voltage Clean or change the probe base if the probe does not move smooth
11. ith mode switch key provided with the tonometer on the bottom of the mode switch hole of the tonometer until the mode change signal is heard The switch must be pressed for approximately three seconds for the mode to change The audible sound indicates the measurement mode one beep normal mode e three beeps automatic mode ADJUSTING THE MEASUREMENT POSITION The tonometer has two adjustable supports one for the forehead and one for the cheek as shown in figure These supports are adjusted to ensure accurate measurement distance and alignment Adjust the supports using the adjustment wheels so the distance from the tip of the probe to the surface of the cornea is 4 8 mm 5 32 5 16 inch and the probe is horizontal www icaretonometer com English Icare tonometer ONE manual English lt Forehead support Adjustment wheels _ lt Cheek support Tonometer forehead and cheek supports with adjustment wheels An optional eye support can be used for easy alignment and additional stability during measurement When the eye support is used the cheek support is not used and needs to be adjusted to minimum setting The eye support can be used for both eyes by rotating it from one side lt Eye support Forehead and eye support with the cheek support in minimum position LOADING THE PROBE The Icare ONE tonometer TA02 uses disposable tonometer probes as shown in figure Each probe is meant for single use only The probes a
12. ly CLEAN LED is lit A NOTE No other service procedures can be carried out by the user All other service and repair must be carried out by the manufacturer or a certified service center SPARE PARTS Single use probes 10 included with the tonometer when purchased Probe base kit Eye supports Mode switch key USB cable Batteries carry on case These can be purchased from a local distributor of Icare products TECHNICAL AND PERFORMANCE DATA Type TA02 The device conforms to CE regulations Dimensions approximately 11 cm x 8 cm x 3 cm Weight approximately 150 g Power supply 2eCR123 batteries make sure you use batteries with built in PTC protection For Example Energizer Lithium Photo 123 3V CR123A Measurement range 5 50 mmHg Display range 5 50 mmHg Accuracy 95 tolerance interval relatively to manometry 1 8 mmHg Repeatability coefficient of variation lt 9 IOP lt 20 mmHg lt 3 IOP gt 20 mmHg e Accuracy of display display is divided into 11 ranges 5 7 mmHg 7 10 mmHg 10 14 mmHg 14 18 mmHg 18 21 mmHg 21 24 mmHg 24 27 mmHg 27 30 mmHg 30 35 mmHg 35 40 mmHg 40 50 mmHg Display unit mmHg The serial number is located 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 12 www icaretonometer com Icare tonometer ONE manual English Operation environm
13. nd by patients under supervision and control of the health care professional Patient use is by prescription only www icaretonometer com Icare tonometer ONE manual English USAGE CONTRAINDICATIONS The TAO2 tonometer is contraindicated in the presence of the following conditions Corneal Scarring Microphtalmos Buphthalmos Nystagmus Keratoconus abnormal central corneal thickness and topical anesthetics INTRODUCTION Icare ONE tonometer is intended to monitor intra ocular Pressure IOP of the human eye It is indicated to be used by health care professionals and by patient under prescription use only It is based on a patented induction based rebound method which allows intraocular pressure IOP to be measured accurately rapidly and without an anesthetic Icare One uses sterilized disposable probes in order to reduce the risk of microbiological contamination to a negligible level Intraocular pressure changes are due to the effects of pulse breathing eye movements and body position Several measurements are taken using the handheld device within fractions of a second to average the micro changes of IOP that occur during measurement In the automated mode six pre programmed measurements are needed to obtain an accurate reading Icare ONE tonometer can be used by glaucoma patients to monitor their intraocular pressure Results are stored in the internal memory of the tonometer and can be transferred to a PC through a USB cable u
14. r s own electromagnetic emissions are well below the levels permitted by the relevant standards they may cause interference in other nearby devices for example sensitive sensors If the device is not to be used for a long time remove its batteries as they may leak Removing the batteries restores the device to normal measurement mode e For every patient to be measured take a new probe to avoid cross contamination of bacteria or viruses and infection of the eye e Use probes taken only from original intact packaging Sterility of the probe cannot be guaranteed once the seal is compromised e The tonometer probes are labeled single use only Re sterilization or re use of the probe can result in incorrect measurement or damage to the probe head e Be sure to dispose of the single use probes properly for example in a container for disposable needles Probes may become contaminated with micro organisms after one time use e Do not connect the USB cable during measurements When connected it is impossible to perform measurement e Do not change the batteries or probe base when the USB cable is connected e Batteries packaging materials and probe bases must be disposed of according to local regulations Use only original probes see Figure 5 and accessories INDICATIONS FOR USE Icare ONE tonometer TA02 is indicated for the monitoring of intraocular pressure IOP of the human eye It is intended to be used by health care professionals a
15. re packed individually in blister ee Disposable tonometer probe and probe container To load the probe 1 Open the lid of the probe container as shown in figure A CAUTION To prevent contamination do not touch the probe tip with fingers Open the probe container 2 Insert the probe into the probe base by turning the probe container upside down as shown in figure www icaretonometer com Icare tonometer ONE manual English Inserting probe into probe base 3 After the probe has been inserted be careful not to point the tonometer downward to prevent the probe from falling out 4 Press the measurement button once to activate the inserted probe During activation the device magnetizes the probe probe moves rapidly back and forth Once the probe is activated the PROBE LED remains lit The tonometer is now ready to take a measurement MEASURING INTRAOCULAR PRESSURE A measurement sequence is a set of six measurements The measurement value shown after all six measurements are taken is displayed on LED display The measurement value is an average of four successful interim measurements of those six interim measurements performed The highest and the lowest value is left out from final value displayed If there is too much variation in average SD error code REPEAT is lit on LED display See error messages and indicators e In the automatic mode the six measurements in a sequence are taken automatically and in
16. sing the Icare LINK software Consult your doctor to interpret the results of the self measurement PACKAGE CONTENTS The package contains Icare ONE tonometer 10 sterilized single use probes 2 eye supports small and large 2 Batteries USB cable User manual Instructions for downloading Icare LINK software Warranty card Carry on case Mode switch key www icaretonometer com Icare tonometer ONE manual English 1 Eye support 2 Support position indicator 3 Measurement button 4 Forehead support 5 Probe 6 Cheek support 7 Probe base IOP indicator LEDs Mode switch Forehead cheek support adjustment wheel PROBE ERROR LED POSITION ERROR LED REPEAT ERROR LED CLEAN ERROR LED NOW PUNR TURNING THE DEVICE ON Press the measurement button to turn the tonometer on All LEDs are displayed briefly One of the lower IOP indicator LEDs remains lit for 2 seconds while other LEDs switch off The LED indicates the battery voltage GREEN OK YELLOW REDUCED RED LOW change battery IOP indicator LEDs One indicator LED remains lit for 2 seconds to show battery voltage PROBE LED POSITION LED REPEAT LED CLEAN LED Tonometer LED panel Following a brief pause the PROBE LED blinks to remind the user to load the single use probe into the tonometer prior to measurement www icaretonometer com icare tonometer ONE manual Accuracy of display display is divided into 1
17. that the first accepted measurement is for the right eye and the second accepted measurement is for the left eye MEASUREMENT STEP Measurement position PATIENT USE INSTRUCTIONS e When taking measurements A NOTE Before performing self tonometry the patient must have the tonometer set up by a health care professional The doctor or nurse has adjusted the distance between the tip of the probe and the center of the cornea with the forehead and cheek support to be 4 8 mm 5 32 5 16 inch A NOTE The tonometer must be held in a vertical position Angle of inclination has limited to 22 to ensure reliable outcome e Doctor or nurse has adjusted the measurement position Doctor or nurse has demonstrated to the patient how to use the tonometer 1 Switch on the unit load the probe 2 Goin front of a wall mirror 3 Take the tonometer in your hand with the white main button pointing upwards 4 Move the tonometer sideways toward your eye so that you see in the mirror the white tip of the probe in front of the black pupil 5 Move the tonometer closer so that the forehead and cheek supports touch the skin 6 Check that the white tip of the probe is seen in front of the center of the cornea pupil 7 Turn the tonometer from the sideway position so that the tonometer with the loaded probe points straight to the center of the cornea pupil 8 Open your eyes wide and try not to blink your eye while measuring 9 Press the measurement
18. the normal mode the user must take each measurement individually until all six measurements are taken To measure intraocular pressure 1 Check that the tonometer is set up correctly and the measurement position is adjusted by a doctor or a nurse 2 The patient should relax and look straight ahead at a specific point while keeping eyes wide open 1 6 1 3 Patient with the tonometer correctly positioned 3 Bring the tonometer near the eye in front of a wall mirror as shown in Figure Measurement step Move the tonometer closer so that the forehead and cheek support touch the skin The distance from the tip of the probe to the center of the cornea must be 4 8 mm 5 32 5 16 inch 4 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 The way you take measurements depends on the chosen mode In Automatic mode press the measurement button once to perform the measurement A long beep indicates the end of one measurement sequence six measurements In automatic mode single measurement values are not shown e In Normal mode press the measurement button to take one individual measurement at a time A short beep sounds after each measurement A long beep sounds when the six measurement sequence is complete In addition to showing the IOP range the accurate IOP value is stored in the internal memory Icare ONE is constan
19. tient 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 16 inch from the eye A WARNING The device probe tips have not been evaluated for the presence of endotoxins The probe tips are for single use only and are packaged sterile A WARNING The Icare ONE Tonometer TA02 is intended to be used only under supervision and control of the health care professional only www icaretonometer com Icare tonometer ONE manual English A WARNING Health care professionals must inform patients not to modify or discontinue their treatment plan without receiving instructions from the health care professional N anni Do not change your medication or dosage without consulting your doctor Misses IOP accuracy and repeatability are unknown for patients with corneal astigmatism gt 3 00 D of astigmatism irregular astigmatism and keratoconus A WARNING Patients with hearing loss may not detect signals that indicating correct measurements N sunau Patients with physical challenges may experience difficulty in using the hand held tonometer N wanna No modification of this equipment is allowed A CAUTION Before using the tonometer read this manual carefully Keep it for future use It contains important information on using and servicing the tonometer
20. tly controlling the measurement position When too far or near from eye or if the measurement angle is too tilted the tonometer beeps twice and displays a red LED indicating an error Position Press the measurement button again to clear the error message and follow the corrective actions according to indicators described on page 10 www icaretonometer com icare tonometer ONE manual In normal mode a value is shown briefly after each successful measurement When the six measurements in sequence are completed and the measurement result is valid the final value range is displayed If there is too much variation between the measurements the REPEAT ERROR LED is displayed and the measurement needs to be performed again The device stores the quality of the measurement in its internal memory which is only accessible by downloading to a PC using the Icare LINK software A new measurement needs to be taken if e REPEAT ERROR LED is displayed for example if the probe made contact with the eyelid e Encountering unusual values for example over 22 mmHg or below 8 mmHg The tonometer s internal memory stores the time and date of a measurement the measurement result and the quality level of the measurement This information can be uploaded to a PC through a USB cable using Icare LINK software The tonometer is taken to a health care professional who can transfer the data A NOTE When using Icare LINK software it assumes by default
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