USER`S AND MAINTENANCE MANUAL
Contents
1. Caution See operating instructions for more Manufacturing date information BF type device LOT Lot number Single use disposable STERILE R Sterilized using irradiation Serial number Stand by Use by lt date gt Do not dispose of in household waste www icaretonometer com 11 TO2. Care EZZFYYTIXYYN PRO USER S AND MAINTENANCE MANUAL ENGLISH Icare tonometer PRO manual English Icare PRO Model INSTRUCTION MANUAL v1 1 01 12 EN This device complies with Medical Device Directive 93 42 EEC Canadian Medical Device Regulations Copyright O 2012 Finland Oy Made in Finland Icare Finland Oy Hevosenkenk 3 FI 02600 Espoo Finland Tel 358 9 8775 1150 Fax 358 9 728 6670 www icarefinland com info icarefinland com Sato IN nee _ ___ ______ ________ ___ ME RIN SANI EM M 3 Indications LIS E caini ma ded na mut ae ip e dd ua Ati tut lt i i mm 4 I EEE CU CUO mr mata il da a dd i il a i d a d a a ft n d i d e a m il i el 4 PODES n aaa a RA ln Ai a bi aa ati ac o i D OM i ia ura da iai MM it 4 Before a NTC U m n 5 ga O 5 ___ _ _6___ _ _ 6_ _ _ _ _ _ _6__ 6_ _ _ _ _____6__ E Sa ata 8 a ea ii 5 __ a a La A aia a n a a IN a a N aa EE a N e d i 0 al 5 Setting up the tonometer before taking measurermebtsdapoepaten a in a ir n n n i at te a ro Dn I 6 L adine the DIODE a rula ni o tn aaa ao da i a nt at Ama iz una sa io aa a n atu n ta 6 Adjusting the measurement POSITION cenis enn rtr e enr i i i il min la ia e nn tt n ci ati i ln a at ne tt n 6 Measuri
3. Disposable tonometer probe blister pack The Icare PRO tonometer uses disposable tonometer probes Probes are packaged into blister packs as shown in the figure Each probe is meant for single use only A Dec 11 12 12 To load the probe v 1 Press the main button to turn the tonometer The Welcome Settings screendisplays followed by the main menu Turn off 2 Goto Measure and press the main button An insert new probe Press main bulton to select or lo return this menu message displays 3 Partially open the package A CAUTION Do not touch the probe directly to prevent contamination 4 Insert the probe from the partially opened package 5 the blister in between your finger and probe and press lightly Be careful not to bend the probe To check probe is correctly inserted tilt unit backward and forward 6 Goto Measure and press the main button once to activate the inserted probe During activation the device magnetizes theprobe probe moves rapidly back and forth Once the probe is activated the tonometer is ready for measurement A NOTE If the tonometer is left idle it turns off automatically after 3 minutes ADJUSTING THE MEASUREMENT POSITION The Icare PRO tonometer has a built in inclination sensor that allows downward measuring of a patient in a supine position as well as in the normal upright position The tonometer has an adjustable forehead support as shown in The support is adju
4. contraindications Corneal Scarring Microphtalmos Bupthalmos Nystagmus Keratoconus abnormal central corneal thickness www icaretonometer com 3 Icare tonometer PRO manual English INDICATIONS FOR USE The Icare PRO tonometer TAO3 is intended to be used by health care professionals to measure intraocular pressure IOP in the human eye INTRODUCTION The Icare PRO tonometer is used in the diagnosis follow up and screening of intraocular pressure It is based on a new patented induction based rebound method which allows intraocular pressure IOP to be measured accurately rapidly and without anesthetic The Icare PRO tonometer has a built in inclination sensor that allows downward measuring of a patient in a supine position as well as in the normal upright position The tonometer can also record and store over one thousand measurement results which can be viewed directly in the tonometer and or transferred to a PC through a USB cable Single use probes are used for measurement to minimize the risk of microbiological contamination Intraocular pressure changes due to the effects of the pulse breathing eye movements and body position As measurements are taken using a handheld device in fractions of a second several measurements are needed to obtain an accurate reading and therefore the device is pre programmed for six measurements PACKAGE CONTENTS The package contains e Icare PRO tonometer USB cable for connectin
5. shown on the screen Settings About There are electrical connections from the tonometer to the patient The device has BF type electric shock protection e Operation environment Temperature 10 C to 35 C O Relative humidity 30 to 90 O Atmospheric pressure 800 hPa 1060 hPa Storage environment O Temperature 10 C to 55 O Relative humidity 10 to 95 O Atmospheric pressure 700 hPa 1060 hPa Transport environment O Temperature 40 C to 70 C O Relative humidity 10 to 95 O Atmospheric pressure 500 hPa 1060 hPa CLINICAL PERFORMANCE DATA Performance data is obtained from a clinical study performed according to ANSI 280 and ISO 8612 for tonometers The estimate of the effect of the reference tonometer on the Icare PRO tonometer value is close to one the coeffi cient of determination is 0 890 The mean of paired difference Goldmann lcare PRO tonometer were 0 0 16 mmHg 0 4 gt 16 lt 23 0 4 223 0 3 and standard deviation is 2 7 15 Scatterplot of IOP values of test tonometer against the IOP values of Goldmann reference tonometer With regression line and 95 confidence intervals identical observations shown only once IOP icare Pro PRO 0 12794 1 00690 1OP GAT 0 0 20 30 40 50 60 IOP Goldmann IE PRO xis D 27939 1006303 0P GAT www icaretonometer com 10 Icare tonometer PRO manual English SYMBOLS
6. CARE PRO TONOMETER S SEPARATE CHARGER ADAPTER To charge PRO tonometer without PC is possible with the charger adapter provided with your tonometer Connect the USB cable to USB charger and the docking station To charge place PRO tonometer to docking station see the image on the right side Do not charge the tonometer with the adapter e Charge Icare PRO tonometer outside the patient environment o Use only the charger provided by your Icare PRO tonometer i A NOTE Do not charge the tonometer directly with the adapter and the USB cable A NOTE Charging the tonometer is only allowed outside the patient environment 1 8 m 6 ft www icaretonometer com 9 Icare tonometer PRO manual English SPARE PARTS AND CONSUMABLES Icare PRO probes 100 pieces per package Probe base kit includes probe base and probe holder TECHNICAL AND PERFORMANCE DATA e Type TAO3 The device conforms to CE regulations Dimensions 225 mm x 46 mm x 90 mm 8 9 x 1 8 x 3 5 Weight 275 g 9 7 oz Power supply rechargeable Lithium lon battery Up to 1000 measurements can be performed with fully charged battery Measurement range 5 50 mmHg e Display range 1 99 9 mmHg Accuracy 1 2 mmHg lt 20 mmHg and 2 2 mmHg gt 20 mmHg Repeatability coefficient of variation 8 96 Accuracy of display 0 1 mmHg e Display unit mmHg The serial number can be
7. Positioning of tonometer is incorrect Incorrect position Probe didn t move properly va Check the probe and base Probe does move correctly or does not move at all If the error repeats change the probe base and probe holder Battery low Battery is low Recharge the battery by placing the tonometer in the docking station This error message is given if probe is continuously not moving smoothly or stops moving Change the probe base and Turn power off POED and clean tonometer TURNING THE TONOMETER OFF Press either navigation button until the display shows Turn off Press the main button the display will show byE and the tonometer will switch off The used probe will be partially ejected Use the used package to remove it from the tonometer Ensure that you dispose of the probe properly www icaretonometer com Icare tonometer PRO manual English CLEANING AND DISINFECTING If the tonometer indicates that the probe is not moving smoothly or that the tonometer needs cleaning the probe base and or probe holder may be dirty or dusty Change the probe base and probe holder by unscrewing the probe cover and replacing the parts with new ones The forehead support must be wiped for each new patient with disinfectant for example an alcoholic solution Do not immerse the tonometer in water or other solution SERVICE PROCEDURES Change the probe base and probe holder if the pr
8. e the probe base when the USB cable is connected 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 A CAUTION Federal US law restricts this device for sale by or on the order of a physician or properly licensed practitioner A CAUTION To avoid cross contamination of bacteria or viruses and infection of the eye take a new probe for every patient measured Use probes taken only from original intact packaging The sterility of the probe cannot be guaranteed once the seal is compromised Resterilization or re use of the probe could result in incorrect measurement values or in the break down of the probe A CAUTION Do not connect Icare PRO tonometer to any charger or equipment other than the docking station TX01 provided with the tonometer A CAUTION Do not touch the USB cable terminal and patient simultaneously A CAUTION Do not place a docking station TX01 charger USB cable or PC together with the tonometer in patient environment The distance from a patient must be more than 1 8m 6 ft When you have opened the package check for any external damage or faults particularly for damage to the case If you suspect that there is something wrong with the tonometer contact the manufacturer or distributor Use the tonometer only for measuring intraocular pressure Any other use is improper and the manufacturer cannot be h
9. eld liable for any damage arising from improper use or for the consequences thereof Never open the casing of the tonometer except for to change the probe base Never use the tonometer in wet damp conditions The probe base screws collar and probes are so small that a child could swallow them Keep the tonometer out of the reach of children Do not use the device near inflammable substances including inflammable anesthetic agents Prior to each measurement check that a new disposable probe from an intact package is being used Certain microbiological agents for example bacteria can be transmitted from the forehead support To avoid this the forehead support must be cleaned for each new patient with disinfectant for example an alcohol solution The tonometer conforms to requirements IEC 60601 1 2 but interference may occur if used near 1m device such as a cellular phone causing high intensity electromagnetic emissions Although the tonometer s own electromagnetic emissions are well below the levels permitted by the relevant standards they may cause interference in other nearby devices for example sensitive sensors Be sure to dispose of the single use probes properly for example in a container for disposable needles because they may contain micro organisms from the patient Dispose of the device components and accessories according to applicable local regulations e Usage
10. g to a PC with Icare LINK software LINK software on USB memory stick Docking station model 1 Charger e Spare parts probe base and probe holder 100 sterilized single use probes e User manual e Warranty certificate Instructions for downloading LINK software and registration of the device Aluminium box Forehead support adjustment wheel Forehead support Collar Probe base Navigation buttons Up Down Left and Right Display Main button DUNT ue DO ROUES Icare tonometer PRO manual English BEFORE USING Read this manual carefully before starting to use the tonometer Make sure the battery is fully charged before using the tonometer for the first time See Charging the battery TURNING THE DEVICE ON mS Dec 11 12 12 Press the main button to turn the tonometer on The tonometer will show a welcome screen Measure TTG followed by the menu The menu has four items Hi stol Settings History Turn off e Settings Hrass main bullan lo select Turn off Main menu NAVIGATING There are navigation buttons left right up and down and a main button which are used to navigate through the menus in the tonometer A navigation button is lit when available A NOTE The left button is typically used to go back to the previous menu when there is no Back to menu item in the menu SETTINGS Use the Settings menu to change the tonometer s settings pack to
11. ific point while keeping rass main button lo select eyes wide open 4 Bring the tonometer near the eye The distance from the tip of the probe to the cornea must be 3 7mm 1 8 2 7 inch as shown in Figure 10 If necessary adjust the distance using the forehead support 5 the main button lightly to perform one individual measurement taking care not to shake the tonometer The tip of the probe should make contact with the central cornea A short beep sounds after each measurement and an interim result is shown on the display 6 Repeat step 5 six times Once the six measurements are complete the final IOP is displayed 7 Press the main button 8 Choose YES to continue measuring the other eye of the same patient Select the eye you want to measure with the navigation button and the press the main button OD OS 9 Ifyou do not want to continue measuring choose NO The results are saved and you can turn off 3 7 mimm the device from the main menu 1 8 2 7 An indication of the reliability of the measurement is displayed below the IOP result If the variation between the measurements is within normal limits the numerical deviation is shown in green If the variation is slightly high the deviation is shown in yellow and a high variation is shown in red If there is a high variation the tonometer suggests repeating the measurement The results of the six individual measurements can be viewed by pressing the navigatio
12. menu To access settings go to Menu gt Settings and press the main button to confirm Brightness Volume History Date Time About in bullor Brightness Change the display brightness 1 Increase or decrease brightness using the up down navigation buttons and press the main button to confirm Brightness ent nisi i Volume Turn the tonometer sounds on or off 1 Select or off using the left right navigation buttons and press the main button to confirm If the sound is off you do not hear the beep when a measurement is taken Date Set the date 1 Select the month day year you want to change using the left right navigation buttons 2 Change month day year using the up down navigation buttons Dec AU 3 Press the main button to confirm Date Time Set the time 1 Select the hour minute second you want to change using the left right navigation buttons 2 Change hour minute second using the up down navigation buttons 3 Press the main button to confirm About Shows important information about your PRO tonometer About Product No TAQ3 Serial No 12345 Sollware version TT www icaretonometer com B Icare tonometer PRO manual English SETTING UP THE TONOMETER BEFORE TAKING MEASUREMENTS Before taking measurements your tonometer must be set up correctly Set up includes Loading the probe Adjusting the measurement position LOA D N G p RO B
13. n down button A new measurement needs to be taken if 11 12 12 e The validity of the measurement is in doubt forexample if the probe i REM made contact with the eyelid or missed the central cornea 05 Left eye OD Right OS Left e The variation is high and the numerical deviation is shown in red 1 5 a 1 5 9 1 When encountering unusual values for example above 22 mmHg or i mie T below 8 mmHg T mmHg mmHg Measurements 6066 MEASUREMENT HISTORY History contains the results of previous measurements To access measurement history 1 Go to Menu gt History and press the main button to confirm The most recent measurement is displayed 2 View previous next measurements using the up down navigation buttons 3 Press left right main button to return to the menu www icaretonometer com Icare tonometer PRO manual English ERROR MESSAGES If an error occurs the PRO tonometer shows it on the display Error messages are explained in the following table A WARNING Indicates that important operating instructions are included in this Instruction Manual The probe does not make clean contact with cornea for example the probe hit an eyelid or eyelashes Incorrect hit a Remeasure Distance between probe and cornea is too great or the probe does not hit cornea at all Distance was too long 6 Distance between probe and cornea is too short Distance was too short a
14. ng intraocular pressure IOP ati aa ti dt ta tt a Ci mt i cd ei ta ani a i mil ta 7 Measurement history mean pot imi ada mat pe 7 DIE seta ao dl aia ia tao See 8 Turning the tonometer OUT aia Sa aaa aci e at a a atac tat Oa usa Enee 8 Cleaning and le _________ auto anii lit ii acuitatea a aaa 9 Service POE MNS e ont oala a ide a aa adi clip dicta da edil eT 9 Charging the Di taci iu acida 9 Icare PRO tonometer s separate charger adaptet isaac aaa a a ai iet imd a al ad ala a d al d d ll al d vi 9 Spareparts and CONSUMaADIES se Muza imun lu a iai Data iei and nds a ta en aa ta Deir d 10 Tech icaland performance ani a ai ant a ini n ut a ani a alai ean 10 Clinical pertormance NORD PRR IIT 10 soi ninti inca ut a d ata a a d nt a nat ta i ape nn n aia M 11 www icaretonometer com 2 Icare tonometer PRO manual English SAFETY INSTRUCTIONS AN WARNING The tonometer must not come into contact with the patient s eyes except for the probes which may do so for a fraction of a second during measurement Do not bring the tonometer into contact with the eye or push it into the eye the tip of the probe should be 3 7 mm or 1 8 2 7 inch from the eye A CAUTION Do not connect the USB cable during measurement A CAUTION Do not chang
15. obe does not move smoothly a clean error message is shown 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 Before sending the device for service make sure you have transferred your measurement data to a PC using LINK software when necessary CHARGING THE BATTERY When the battery is low an error message indicates that you must recharge it Place the tonometer in the docking station that is provided with your tonometer Attach the docking station to a PC using a USB cable Charging the battery fully takes approximately one hour When a green light is blinking in the upper navigation button the tonometer is charging When the green light is constant charging is complete Do not charge the tonometer within the patient s environment Avoid extreme conditions High and low temperatures will reduce the capacity of the battery In order to recharge at maximum rate LINK software must be installed See installation instructions in LINK User Manual or a separate installation instruction sheet provided with the software Use only a PC that complies to the IEC 60950 standard or the charger provided To charge PRO tonometer without a PC is possible with the charger adapter provided with your tonometer Connect the USB cable to the USB charger and the docking station To charge Icare PRO place the tonometer in the docking station I
16. sted to ensure accurate measurement distance and alignment 1 8 2 7 Adjustable forehead support Patient with the tonometer correctly positioned Measuring supine patient Adjust the forehead support using the adjustment wheel so the distance from the tip of the probe to the surface of the cornea is 3 7mm 1 8 2 7 inch When the tonometer is tilted to measure a supine patient the probe is automatically held in place When measuring a supine patient an arrow appears in the display that indicates the vertical position of the device www icaretonometer com 6 Icare tonometer PRO manual English MEASURING INTRAOCULAR PRESSURE A measurement sequence is a set of six measurements Six measurements are necessary to obtain the most accurate reading but the result is also displayed after each measurement The measurement value shown after six measurements are taken displays an average value AN vos Anesthetic is not required when performing measurements If used it may lower the tonometer reading To measure intraocular pressure Dec 11 12 12 Dec 11 12 12 1 Check that the tonometer is set up correctly Setting up the tonometer before Select eye Select eye taking measurements i 2 Goto Menu Measure and press the main button Select the eye you want to Right Left measure using the left and right navigation buttons and press the main button to on 05 confirm 3 Tell the patient to relax and look straight ahead at a spec
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