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Summary of Contents for Keeler Tonocare
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- Page 2 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. Back...
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Page 3: Table Of Contents
3.2.8 Printing data ............p26 2.0 Installation ..............p9 3.3 Replacing the printer paper ........p27 2.1 Tools required ............p9 3.4 Charging your TonoCare ........p28 2.2 Packaging content ...........p9 4.0 Product care and maintenance ........p29 2.3 Table top installation ..........p10 4.1 General product care ..........p29 2.4 Wall mount installation .........p11... -
Page 4: Introduction
1.0 Introduction 1.4 Principle of operation Thank you for purchasing the Keeler TonoCare™. The Keeler TonoCare Tonometer uses the principle of air impulse These Instructions For Use are addressed to healthcare tonometry - this is a variation of general applanation tonometry, professionals using the TonoCare Non-contact Tonometer. -
Page 5: Symbols Information
1.5 Symbols information Please pay attention to the description of symbols below, as they will be used throughout the manual, device and packaging. Follow instructions for use Manufacturer’s name and address This way up The CE mark on this product Mandatory action sign Date of manufacture indicates it has been tested to, and... -
Page 6: Symbols Used On Controls And Display
1.6 Symbols used on controls and display Please pay attention to the description of the symbols and sounds below, as they will be used on the device and display during operation. Device Controls Display Symbols Description Light Turn on / off illumination LEDs On/Standby button Sound Turn on/off audible alerts... -
Page 7: Warnings And Cautions
• TonoCare is not intended to be used with wireless technology. • The TonoCare cannot be used in the vicinity of sources known Do not plug a wireless dongle into the USB port on the docking to cause electromagnetic disturbance (magnetic resonance station. - Page 8 Warnings and Cautions – failure to follow these instructions may pose a risk of injury Operation and use • Contact of the front window / nozzle area of the TonoCare with (continued) the eye of the patient should be avoided. If accidental contact •...
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Page 9: Installation
2.2 Packaging Content This chapter will instruct how to unpack and prepare the TonoCare for use. Your TonoCare has been supplied with: • A hand unit with pre-installed battery for IOP standalone When you open the package, check for any external measurement. -
Page 10: Table Top Installation
3. Lift the docking station from the package and place it in a 7. Remove the power supply from the package, plug it to the clean area intended for the charging of the TonoCare when back of the docking station and after fitting the suitable not in use. -
Page 11: Wall Mount Installation
2.4 Wall Mount Installation Your TonoCare has been supplied with a wall mounting plate, 4. Insert the rawlplugs in the holes drilled in the previous step, 4 screws and 4 rawlplugs. Follow the instructions below for wall and fix the metal plate on the wall with the screws provided, mounting. -
Page 12: Using The Tonocare
3.0 Using the TonoCare This section will instruct the user on how to interpret the controls and indicators of the TonoCare, and how to perform the IOP measurement on a patient using the device. Familiarise yourself with the instructions for the measurement of the IOP using the TonoCare, before using the instrument on a patient. -
Page 13: Hand Unit
3.1.1 Hand Unit (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. -
Page 14: Docking Station
3.1.2 Docking station • Rear view • Underside view 17. Charging contacts 21. Power input 18. Infrared receiver 22. USB interface 19. Printer door • Allows device to be connected to a PC for raw data 20. Wall mounting holes upload purposes •... -
Page 15: Menu Map
3.1.3 Menu Map Press the menu button to open the software menu. Once in software menu, use the menu button to change your selection, the print button to confirm and the return button to move to the previous menu. Follow the menu map in the figure below for guidance. Confirm (Print button) The software revision is displayed during start-up... -
Page 16: Measurement
If you suspect the unit has been subjected to any impacts or moisture ingress do not use the device. Contact Keeler or your local service centre for advice. 2. Keeler recommends performing a weekly self-test on the hand unit to confirm functionality. -
Page 17: Preparing The Unit
The TonoCare software will recognise the readings and give an audible notification when two consecutive readings are within 3. In order to reassure the patient, you can demonstrate the... -
Page 18: Obtaining A Measurement
/ demo button to dispel any minute particles of dust or from the patient’s eye, a cross will appear to indicate the moisture which may have settled whilst the TonoCare was not position of the device relative to the eye. Move the device so in use. - Page 19 (if sounds are enabled in the menu settings). 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.
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Page 20: Repeatability And Reproducibility
0.05 and an R-square value of 98% or 99%, which signifies excellent reproducibility across Repeatability was measured using a single TonoCare device and operator and across devices. a series of approximately 50 individual readings for each of 5 pressure values spaced evenly between the 5 to 50mmHg working range. -
Page 21: Clinical Performance Data
Perkins Applanation Tonometer (AT) in order The results of the study show that the IOP measurements taken to assess whether the TonoCare meets the requirements of ISO with the TonoCare NCT when compared to the reference Perkins 8612 (comparable to ANSI Z80.10) in design compliance testing. - Page 22 From the included 72 participants, IOP was measured in both eyes of all participants with TonoCare and Perkins AT, giving paired IOP measurements for a total of 144 eyes. Home...
- Page 23 >5mm Hg overall, and within 3 IOP subgroups. Table 1 below gives summary of IOP characteristics of the group, showing measurements to have similar distributions. IOP Group † Table 1: Summary of TonoCare and Perkins AT IOP measurements. 7 to 17 to 16mmHg 23mmHg >23mmHg**...
- Page 24 ** 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 clinically meaningful differences in IOP measurements among the tonometers, and that the TonoCare conforms to the standard as detailed. Home Back...
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Page 25: Cct Correction
3. The CCT screen will show the CCT group and the correction corneal abnormalities potentially affecting rigidity (e.g., applied under the relevant eye. keratoconus, corneal transplant, crosslinking) in addition to intrinsic structural factors and corneal refractive surgery. TonoCare CCT Workflow Menu button CCT dialog Return button Short press... -
Page 26: Printing Data
The last four individual readings are printed as whole numbers ‘XX’. The TonoCare docking station can also be connected to a USB port on a PC. It will appear as a serial port in the system. The average IOP is calculated and printed to one decimal place ‘XX.X’. -
Page 27: Replacing The Printer Paper
3.3 Replacing the printer paper 1. Access to the printer paper is via the printer cover. Using your fingertip, locate the lip on the top of the cover and gently pull towards you to open the printer housing. 2. Remove any leftover paper roll. 3. -
Page 28: Charging Your Tonocare
3.4 Charging your TonoCare When not in use Keeler recommends storing your 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. -
Page 29: Product Care And Maintenance
Contact your local dealer for a repair. These should only be done by personnel trained and replacement. qualified 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... -
Page 30: Cleaning
4.2 Cleaning Clean the hand unit daily and between patients Do not autoclave or immerse in cleaning fluids. Always disconnect power supply from source before cleaning. 1. Wipe the external surface with a clean absorbent, Disinfect the unit carefully following the procedures and non-shedding cloth dampened with a water/detergent cleaning solutions described below. -
Page 31: Maintenance
4.4 Fault Codes If the TonoCare is dropped by accident the same service centre or distributor can verify if the device is still in calibration. If an Error Code between 00 to 34 is seen on the screen, restart the device and check its function. -
Page 32: Specifications And Electrical Ratings
(110 – 240V)+/- 10% mains supply – ensure the mains plug is accessible at all times. 350-700mA * If connecting the TonoCare to a computer, the computer shall Compliant to: comply with the requirements of EN 60601-1:2006 EN 60601-1, EN 61000-6-2,... - Page 33 Many ophthalmic instruments illuminate the eye with intense light. The light levels on the TonoCare have been set at the lowest level possible. Figure 1: Spectral irradiance of instrument at patient plane...
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Page 34: Specifications And Electrical Ratings (Emc)
6.0 Specifications and electrical ratings (EMC) 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. - Page 35 6.0 Specifications and electrical ratings (EMC) (continued) Guidance and manufacturer’s declaration – electromagnetic immunity The Keeler TonoCare is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity test...
- Page 36 6.0 Specifications and electrical ratings (EMC) (continued) Guidance and manufacturer’s declaration – electromagnetic emissions The Keeler TonoCare is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. Emissions test...
- Page 37 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Keeler TonoCare is used exceeds the applicable RF compliance level above, the Keeler TonoCare should be observed to verify normal operation.
- Page 38 Recommended separation distances between portable and mobile RF communications equipment and the Keeler TonoCare The Keeler TonoCare is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Keeler TonoCare can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Keeler TonoCare as recommended below, according to the maximum output power of the communications equipment.
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Page 39: Accessories And Warranty
EP79-40370 USB cable (docking station to PC) 2418-P-7000 Forehead rest 2415-P-7007 Instruction for Use and TonoCare Export App on USB device EP29-32777 Power supply TonoCare warranty The TonoCare and its components are covered by warranty The obligations of the manufacturer as set forth in this warranty... -
Page 40: Contact, Packaging And Disposal Information
8.0 Contact, packaging and disposal information Keeler Ltd Keeler Instruments Inc. Clewer Hill Road 3222 Phoenixville Pike #50 Windsor Malvern Berkshire SL4 4AA PA 19355 United Kingdom United States Freephone: 0800 521251 Toll Free: +1 800 523 5620 Tel: +44 (0) 1753 857177...
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