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The Keeler TonoCare is a medical electrical instrument. The instrument requires
special care concerning electromagnetic compatibility (EMC). This section describes the
suitability in terms of electromagnetic compatibility of this instrument. When installing
or using this instrument, please read carefully and observe what is described here.

Portable or mobile-type radio frequency communication units may have an adverse
effect on this instrument, resulting in malfunctioning.

6.0 Specifications and electrical ratings (EMC)

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Summary of Contents for Tonocare

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Page 2: ...thout the manufacturer s prior written approval The manufacturer reserves the right to make changes to specifications and other information contained in this document without prior notice TonoCare is a registered Trademark of Keeler Limited 2017 Copyright Keeler Limited 2016 Published in the UK 2017 ...

Page 3: ...3 2 Measurement p16 3 2 1 Routine checks and functional tests p16 3 2 2 Preparing the unit p17 3 2 3 Preparing the patient p17 3 2 4 Obtaining a measurement p18 3 2 5 Repeatability and reproducibility p20 3 2 6 Clinical performance data p21 3 2 7 CCT correction p25 3 2 8 Printing data p26 3 3 Replacing the printer paper p27 3 4 Charging your TonoCare p28 4 0 Product care and maintenance p29 4 1 Ge...

Page 4: ...ple of operation The Keeler TonoCare Tonometer uses the principle of air impulse tonometry this is a variation of general applanation tonometry however does not require direct contact with the surface of the eye Applanation tonometry is a technology to accurately measure IOP as an equivalent of the force required to flatten a defined area of the cornea by mechanical stimuli as a direct application...

Page 5: ...damaged Fragile Keep dry Temperature limits Humidity limits Atmospheric pressure limits This way up The CE mark on this product indicates it has been tested to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive This symbol on the product or its packaging indicates it was put on the market place after August 2006 and this product shall not be treated as household w...

Page 6: ...f measurements obtained Device Controls Display Symbols Description Light Turn on off illumination LEDs Sound Turn on off audible alerts Time Set the system time Date Set the system date IOP Format Select the IOP format XX XX X Pachymetry Pachymetry options of OFF ON TRIGGER If set to TRIGGER the pachymetry option only appears if the measured IOP value is greater than 15 Brightness Set the brightn...

Page 7: ...rding to Keeler Instructions Keep out of reach of children Do not mount anything on the docking station other than the hand unit and forehead rest The mains plug is the means of isolating the device from mains supply ensure the mains plug is accessible at all times Do not position the equipment so that is difficult to remove the mains plug from the wall socket Do not fit mains power adapter into a...

Page 8: ...of aluminium and it is the only part which may touch the patient The housing of the instrument is made of PC ABS Do not touch these parts if you have a known allergy to any of the materials Do not use the forehead rest in the docking station for any other instrument or the performance of the product may be compromised Contact of the front window nozzle area of the TonoCare with the eye of the pati...

Page 9: ...ontent Your TonoCare has been supplied with A hand unit with pre installed battery for IOP standalone measurement A docking station for printing data export and charging functions A metal wall mounting plate with 4 screws and 4 rawlplugs for wall mounting of the docking station A power supply for directly charging the hand unit in transport or via the docking station A roll of thermal paper to be ...

Page 10: ...tions on installation replacement of thermal paper 5 Remove the hand unit from the package and allow the handle to fit the lower recess in the docking station and the measurement window to slide onto the top of the docking station Before use remove the protective film covering the TonoCare display the Front Window and the IR Window 6 Take the forehead stabilizer from the package and allow it to be...

Page 11: ...s a template to mark the position of the retaining screws with a pencil holding a spirit level to the base of the plate to guarantee horizontal alignment 3 Drill the appropriate size holes following the marks left from the previous step Use extreme caution when operating the drill following the instructions provided with the instrument 4 Insert the rawlplugs in the holes drilled in the previous st...

Page 12: ...self with the instructions for the measurement of the IOP using the TonoCare before using the instrument on a patient 3 1 Controls and indicators 3 1 1 Hand Unit Top view 1 Forehead rest mounting 2 Manual trigger 3 OD OS button 4 LED indicator 5 Digital display 6 On Off 7 Print button 8 Menu button 9 Return button Note The LED indicator on the TonoCare pulses when charging and remains solid when f...

Page 13: ...nit continued Isometric view from the user and left side 10 Forehead rest 11 Eyepiece View from underneath the device 12 Charging contacts 13 Power input Patient view 14 Puff tube and window 15 LED indicator 16 Infrared transmitter ...

Page 14: ... view 21 Power input 22 USB interface Allows device to be connected to a PC for raw data upload purposes View to show position of Hand Unit with Docking Station Rear view 17 Charging contacts 18 Infrared receiver 19 Printer door 20 Wall mounting holes ...

Page 15: ...button to move to the previous menu Follow the menu map in the figure below for guidance 3 1 3 Menu Map Confirm Print button Change selection Menu button Return to previous menu Return button The software revision is displayed during start up Main Menu Light Buzzer Time Date Resolution CCT Brightness Self Test On Off On Off HH DD XX On Off Trigger On Off On Off MM MM XX X YY ...

Page 16: ...ration system and the pressure sensor To access the self test facility follow these steps a Power the unit up ensuring it is plugged into the mains power supply b Rest the unit on its side on a flat surface such as on a desk Do not hold the unit c Press and hold the menu button and scroll through until the icon appears on the display d Using the print or return button set this to ON e Press and ho...

Page 17: ...ing that further measurements may not be required 3 2 2 Preparing the unit 1 Before lifting the hand unit from the docking station check the LED indicator is steady on to ensure full battery capacity A full battery will last up to 2 days of intensive use Performance will deteriorate over time 2 Remove the hand unit from the docking station and press the power on button The hand unit will enter sta...

Page 18: ...e instrument forward whilst aligning the positioning ring to the patient s iris Centre the measurement area with the pupil of the patient s eye and make note of the reflected LED crescents These should be central on the pupil as well 6 When the device is approximately 15mm 0 5 inches away from the patient s eye a cross will appear to indicate the position of the device relative to the eye Move the...

Page 19: ...If successive readings are not within 1mmHg of each other Keeler recommends taking up to four readings and using the average 12 Press the OD OS button to switch from left to right eye or vice versa 13 Press and hold the OD OS button to clear all the readings 14 Pressing the print button will produce a paper printout from the printer installed in the docking station The infra red window in the dock...

Page 20: ...ach of the 5 pressure values Results demonstrate standard deviations ranging from 0 14mmHg to 1 11mmHg within the 5 to 50mmHg pressure range respectively Reproducibility was assessed by analysing measurements from three different TonoCare units by two different operators across 5 pressure values spaced evenly between the 5 to 50mmHg working range Two measurements an average of 4 readings at the 5 ...

Page 21: ...t al 1990 Carlos Garcia Resua et al 2006 useful in domiciliary visits and for patients with mobility issues Two experienced observers acquired data from 144 qualifying eyes measuring IOPs ranging from 7mmHg 23mmHg in 50 participants and IOPs greater than 23mmHg in 22 participants The results of the study show that the IOP measurements taken with the TonoCare NCT when compared to the reference Perk...

Page 22: ...bjects with one eye having poor or eccentric fixation High corneal astigmatism 3D Corneal scarring corneal surgery including laser corneal surgery Microphthalmosis Buphthalmos Contact lens wearers Dry eyes Lid squeezers Nystagmus Keratoconus Any other corneal or conjunctival pathology or infection A total of 74 eligible participants were recruited with 2 participants 2 7 excluded The reason for ex...

Page 23: ...and within 3 IOP subgroups IOP TonoCare IOP Perkins AT Based on Perkins AT measured IOP In order to obtain measurements in this range an inversion procedure was performed on a subset of participants while taking IOP measurements Summary parameters of differences between pairs of TonoCare and Perkins AT IOP measurements are given in Table 3 below for the full sample and by each IOP group Overall th...

Page 24: ... measures of IOP differences taken with TonoCare and Perkins AT measurements summarised overall and within 3 IOP subgroups Based on Perkins AT measured IOP Standard deviation Interquartile range In order to obtain measurements in this range an inversion procedure was performed on a subset of participants while taking IOP measurements It was concluded by the investigators that there are no clinical...

Page 25: ...button Short press CCT dialog selection list Return button Menu button Short press CCT dialog selection list Return button OD OS Button OS OD 1 OD 2 OD CCT 3 OS 4 OS CCT TonoCare CCT Workflow The accuracy of IOP measurements is known to be affected by variations and changes in corneal rigidity due to differences in corneal thickness intrinsic structural factors or corneal refractive surgery It is ...

Page 26: ...e TonoCare Export application matches the readings on the hand unit The printer on the docking station contains a sharp serrated blade to help cut the paper Exercise caution to avoid contact with this blade whenever replacing printer paper rolls or tearing printouts from the device Example The TonoCare docking station can also be connected to a USB port on a PC It will appear as a serial port in t...

Page 27: ...king sure the free end is loose at the top of the roll and oriented as shown 4 Extend a few centimetres of paper out of the housing While holding the end of the paper close the cover by gently pushing the lip at the top towards the docking station until it is fully closed and clicks into place The printer on the docking station contains a sharp serrated blade to help cut the paper Exercise caution...

Page 28: ... TonoCare on the docking station so that it is maintained fully charged and ready for use The LED on the TonoCare pulses when charging Once fully charged the LED will be continuously lit The LED on the Docking Station will not change when the TonoCare hand set is stored on the Docking Station ...

Page 29: ...ualified by Keeler following the instructions in the service manual Do not store the product in a dusty environment as the dust may enter the puff system and be dispelled to the patient s eye during use Regular inspection Inspect your power supply unit and cable for damage regularly Before inspecting disconnect the power supply from the TonoCare and the mains supply If the outer insulation of the ...

Page 30: ...ken not to damage the puff tube assembly during cleaning Never use a dry cotton bud or tissue to clean the puff tube lens Never use a silicone impregnated cloth or tissue to clean the puff tube lens Clean the hand unit daily and between patients 1 Wipe the external surface with a clean absorbent non shedding cloth dampened with a water detergent solution 2 detergent by volume or water isopropyl al...

Page 31: ...till in calibration The unit performs a self function check when switched on and will indicate if a fault is found A further self test can be activated from the menu refer to section 3 2 1 Do not attempt to perform any unauthorized repairs as this could endanger the product and patients Do not allow unauthorized parts to be fitted in your product On request Keeler will provide necessary circuit di...

Page 32: ...vel Displayed accuracy Display accuracy to 1 decimal place e g 12 3 Working distance 11mm from surface of patient s cornea to front surface of the window Display OLED 0 95 Illumination system LED white and infrared The ME Equipment includes the hand unit the docking station the forehead rest and the power supply Docking Station Electric shock protection Class II IP rating IPX0 Dimensions 153 x 155...

Page 33: ...sk The risk may also be slightly increased if the person being examined has had any exposure with the same instrument or another ophthalmic instrument using an intense visible light source during the previous 24 hours This will apply particularly if the eye has been subjected to retinal photography 5 0 Specifications and electrical ratings continued Parameter Wavelength nm Storage Transport ES CL ...

Page 34: ...on describes the suitability in terms of electromagnetic compatibility of this instrument When installing or using this instrument please read carefully and observe what is described here Portable or mobile type radio frequency communication units may have an adverse effect on this instrument resulting in malfunctioning 6 0 Specifications and electrical ratings EMC ...

Page 35: ...al or hospital environment Surge IEC 61000 4 5 1 kV line s to neutral 1 kV line s to neutral Mains power quality should be that of a typical commercial or hospital environment Voltage dips IEC 61000 4 11 Voltage Interruptions IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 1 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 500ms 5 UT 95 dip in UT for 5s 0 UT 0 5 cy...

Page 36: ...ssions CISPR 11 Group 1 The Keeler TonoCare uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Keeler TonoCare is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply ...

Page 37: ...d strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guide lines may not apply in all situations Electromagnetic propagation is affected by a...

Page 38: ...tions equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 50 kHz to 80MHz d 1 2 p 80MHz to 800MHz d 1 2 p 800MHz to 2 5GHz d 2 3 p 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 74 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be det...

Page 39: ...that it shall have no remedy in the event of any breach of the foregoing warranty other than as provided above This warranty is exclusive and in lieu of all other warranties expressed or implied and all implied warranties of merchantability or fitness for a particular purpose are expressly disclaimed The obligations of the manufacturer as set forth in this warranty are expressly conditioned on the...

Page 40: ...this product shall not be treated as household waste To Reduce the Environmental impact of WEEE Waste Electrical Electronic Equipment and minimise the volume of WEEE entering landfills we encourage at Product end of life that this Equipment is recycled and reused 0088 Keeler Ltd Clewer Hill Road Windsor Berkshire SL4 4AA United Kingdom Freephone 0800 521251 Tel 44 0 1753 857177 Fax 44 0 1753 82714...

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