Keeler IntelliPuff User Manual English
Contents
1. Regular inspection Inspect your power supply unit and cable for damage regularly Before inspecting disconnect the power supply from the Pulsair intelliPuff and the mains If the outer insulation of the cable appears to be damaged discontinue use immediately Contact your local dealer for a replacement Keeler Home Back Next Calibration maintenance and inspection General Keep the instrument free from dust If the unit is to remain unused for any length of time turn the On off push button switch to Off and remove the power supply Use the dust cover to protect the unit Before using the Pulsair intelliPuff again press the Demo button to dispel any minute particles of dust Servicing and calibration Keeler recommends an annual calibration for the Tonometer This must be performed by an authorised Pulsair service centre or distributor The unit performs a self function check when switched on and will indicate if a fault is found Keeler Home Back Next Specifications and electrical ratings Console dimensions Hand Unit dimensions Console weight Hand Unit weight Calibrated range Displayed accuracy Working distance Displayed scale Illumination system Length of umbilical cord Complies with Power Supply Unit Power supply output Frequency 260 x 215 x 220mm Hx Dx W 315 x 150 x 46mm Hx Dx W 2 465Kg 0 890Kg 5mmHg to 50mmHg 0 1mmHg 20mm from surface of patient s corne2. If 0 1 significant figure is selected using the menu options In this case there is no indication on the display that the reading is the first or average of more than 1 When a pressure IOP of greater than 25mmHdg is detected the unit will display gt 25 the puff intensity will automatically be increased from the soft puff to the normal puff level for subsequent measurements The unit will perform regular self tests if a possible discrepancy in operating parameters is suspected the run self test message will be displayed for up to 15 seconds To continue to use the unit press the OD OS button to clear the message The results displayed thereafter may be suspect Refer to the user menu options section in this manual for guidance on running the self test Display shows error Signified by a long high pitch sound Keeler Home Back Next Printing The results can be printed by pressing the print button on the handpiece or if the user menu is set to automatically print by replacing the handpiece in the cradle Sample print The reading in brackets 20 indicates a discarded value not taking into account in the average calculations The Name Date and Time fields are to be manually written in by the operator Average is printed in XX X and data in only 2 digits Only the last 4 of data on each eye are printed Keeler Name Date Time Right Eye Avg IOP 1 amp 4 mmHg Data 28
3. 19 19 10 Left Eye Avg IOP 18 5 mmHg Data 19 11 18 18 Keeler Home Back Next Replacing the printer paper 1 Access to the printer paper is via the printer cover use your finger in the lip on the top of the cover and gently pull towards you to open the printer cover Remove the empty paper roll 2 Place the new roll of paper into the paper holder making sure the free end is loose at the top of the roll 3 Feed the free end of paper through the gap in the cover 4 Close the cover Keeler Home Back Next User menu options 1 With the unit switched on and the handpiece removed press and IntelliPuff levels hold menu button for more than 3 second to enter the user menu Clinical CLIN Clinical mode will give the most accurate IOP measurement possible with this hand held Tonometer In this 2 The display will show the first user option and the current a o mode precise alignment is essential in order to satisfy the firing selection i e prnt off or ornt on Ip Ip criteria It is recommended to set the IOP format to xx x when 3 To change the user option press the CHANGE button once in this mode toggling the CHANGE button will cycle through the option s Auto AUTO Auto mode will automatically reduce the alignment sensitivity of the Pulsair when there is some difficulty in The Me User Op OT U NE case tie AE comme achieving the firing criteria AUTO mode is the default setting 4 Pre
4. not positioned under direct lighting i e spot lights or sunlight 3 Ensure the patient s eyes are fully opened This helps to prevent squeezing where the patient unconsciously tenses their eyelids and increases IOP 4 Throughout the reading process you should Allow the patient to blink at intervals in order to maintain the corneal tear film Keeler Home Back Next Taking the reading Once the Pulsair intelliPuff and the patient are prepared you are ready to take a reading 1 The Pulsair intelliPuff is set to automatically select the right eye as the first eye to be measured If you wish to select the left eye press the OD OS button on the hand unit Lift the hand unit the pump starts and the two green LED s illuminate From a distance of about 30 cms 12 inches look through the eyepiece and locate the patient s eye Slowly move closer to the patient maintaining alignment Support the Pulsair intelliPuff against your free hand and or use the pop out forehead stabilizer Continue to move in slowly towards the patient two green dots appear Continue to move closer a red reflex appears Move closer At a distance of approximately 15mm a black cross on red or bow tie image appears Centre this image on the central bar and the Pulsair intelliPuff fires Once you have taken a reading remain in the operating position wait a few seconds for the air chamber to refil
5. the cover and gently pull towards you to open the printer cover 5 Serial port The serial port is used for calibration systems checking and data output located on rear of instrument 6 Power input Keeler Insert the low voltage power lead located on rear of instrument use only Keeler power supplies Home Back Next Names of controls and components 9 Display When all the required readings have been taken the figure The display shows the recorded IOP reading and the averaged displayed is the IOP that is recorded for the patient IOP reading When two consecutive readings are within 1mmHg an audible sound will be heard indicating that sufficient readings may After the first reading is taken the display shows the measured have been taken IOP After each of the consecutive reading is taken the display shows the average of the readings taken so far i e the first figure displayed is the actual reading the second figure is an average of the first two readings etc up to a maximum of 4 readings per eye Note The displayed figure is rounded to the nearest whole number or displayed to one decimal place depending on the user setting accessed via the menu The displayed average is based on the actual readings which are taken to one decimal place For example readings of 15 4 16 3 14 2 and 16 9 are averaged by adding them together which equals 62 8 and dividing by the number of readings taken 4 This gives a final f
6. Pulsair CISD Instructions for use Keeler Next Contents 9 Copyright and Trademarks Introduction Symbols Warnings and cautions Cleaning instructions Power supply assembly Wall mounting Tonometry pressure variations in the human eye Names of controls and components 10 Measurement procedures 11 12 13 14 15 16 17 18 19 20 Preparing the patient Taking the reading Display examples Printing Replacing the printer paper User menu options Calibration maintenance and inspection Specifications and electrical ratings Accessories Contact and disposal information Please click on the contents to go straight to your chosen section or navigate by using the Next Keeler and Back buttons to the right Clicking on Home will bring you back to this page Back Next As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice Copyright and Trademarks The information contained within this manual must not be reproduced in whole or part without 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 Pulsair intelliPuff is a registered Trademark of Keeler Limited 2007 Copyright Keeler Limited 2007 Published in the UK April 2007 Description of the p
7. a to front surface of first lens This equates to a nominal distance of 15mm from the front of the puff tube shroud to the front surface of the patient s cornea 4 character dot matrix scrolling LED infra red 2M Safety Medical EN 60601 1 1990 plus amendments A1 1993 A11 1993 A12 1993 A2 1995 and A13 1996 EN ISO 15004 1998 Clause 6 3 optical radiation hazard Clause 7 3 environmental conditions EN60601 1 2 for EMC Switch mode 110 240V 10 multi plug type compliant to EN 60601 1 EN 61000 6 2 EN 61000 6 3 30 VA 12V DC 2 5A 50 60 Hz Keeler Home Back Next Specifications and electrical ratings It is well established that exposure of the eye to intense light 0 8 sources for extended periods of time poses a risk of retinal photic E 5 a ng 28 l i 2 injury Many ophthalmic instruments illuminate the eye with z 0 6 Green intense light The light levels on the Pulsair have been set at the lowest level possible 2 a O 2 0 2 No visible retinal lesions have been identified as a result of using 5 Pulsair tonometers however young children and persons with g 0 oH diseased eyes may be at a higher risk The risk may also be slightly 300 400 500 600 700 800 900 1000 1100 increased if the person being examined has had any exposure Wavelength nm with the same instrument or an other ophthalmic instrument Figure 1 Spectral irradiance of instrument at user plane using an intense visible light so
8. ches trom the patient you will twee the green alignment Got to guide you wat you will we fe red shgnment bary comtinwe the approach 6 Now you will see the black coss on the red alignment bars This is the firing powtion the unit will automatically trigger when alignment is corect Note For quick alignment reference please refer to the short form instructions located at the rear of the instrument and accessed by using the pull out tab on the back left hand side tys tone 4 s Sorat t for ta t atra oF A te 4 wher to Pull out short form instructions Keeler Home Back Next Preparing the patient Before using the Pulsair intelliPuff you should make your patient feel at ease and ensure they are located in an optimum reading location preferably with their head supported This is because apprehension and nervousness may adversely affect the readings obtained Follow the points outlined below to achieve this 1 Ensure that the patient is comfortable and in a relaxed position 2 Ask the patient to remove their contact lenses or spectacles if worn and to blink and breathe normally 3 In order to reassure the patient you can demonstrate the procedure using the Demo button on the back of the patient s hand prior to taking a reading Before taking a reading you should 1 Ask the patient to blink to ensure a good and reflective tear film 2 Ensure the patient and instrument optics are
9. ct is visibly damaged and periodically inspect for signs of damage e Do not use in the presence of flammable gases e This product should not be immersed in fluids e Do not fit mains power adapter into a damaged mains outlet socket e Route power cords safely to eliminate risk of tripping or damage to user e Federal law restricts this device to sale by or order of a physician e Only use approved Keeler power supply EP39 32777 AN Caution e The product has been designed to function safely when at an ambient temperature between 10 C and 35 C e Use correct Keeler power supply e Keep out of the reach of children e To prevent condensation from forming allow instrument to come to room temperature before use e Only mount on wall according to Keeler Instructions Keeler Home Back Next Cleaning instructions Only manual non immersion cleaning as described should be used for this instrument Do not autoclave or immerse in cleaning fluids Always disconnect power supply from source before cleaning a Wipe the external surface with a clean absorbent non shedding cloth dampened with a water detergent solution 2 detergent by volume or water isopropyl alcohol solution 70 IPA by volume Avoid optical surfaces b Ensure that excess solution does not enter the instrument Use caution to ensure cloth is not saturated with solution c Surfaces must be carefully hand dried using a clean non she
10. dding cloth d Safely dispose of used cleaning materials Keeler Home Back Next Power supply assembly Set Plug Replace the blanking plate with the appropriate mains plug adapter if required or use IEC 60320 TYPE 7 connector not supplied oe a cameron sae Keeler Home Back Next Wall mounting Your Pulsair intelliPuff is supplied with a sturdy wall mounting bracket 1 The bracket has four holes allowing it to be securely fixed to an appropriate wall or vertical surface 2 Choose carefully the intended location for your intelliPuff with particular consideration to health and safety aspects for example the routing of the power lead and it s position in regard to the user and the patient 3 Use the wall mounting bracket as a template and clearly mark the position of the holes in the wall Ensure that there are no live utilities where you are to drill 4 Drill the appropriate size holes for the screws and rawplugs supplied 5 Attach the plate securely to the wall 6 Carefully locate the mounting pegs of the plate to the key holes on the back of your Pulsair intelliPuff and allow the Keeler Pulsair be lowered into its final and secure position Home Back Next Tonometry pressure variations in the human eye The Keeler Pulsair intelliPuff measures intra ocular pressure by automatically releasing a gentle puff of air onto the cornea This is known as an event An single reading can
11. igure of 15 7 or 16 depending on user settings Keeler Home Back Next Names of controls and components Main control buttons 10 Print Menu button A press of less than one second will print the acquired data press and hold for more than 3 seconds to access the menu and sub menu functions 11 Review button You can review the readings taken at any time Press the Review button The display shows the readings taken in the order they were taken the final figure displayed is the cumulative average the IOP The Pulsair memory is retains a rolling four readings per eye New readings automatically replace the oldest To review the other eye press the OD OS button once and then press the review button To clear the memory you can either replace the hand unit in the holster and remove again or press the Demo button 12 Demo button The demo button will produce a sample puff to demonstrate to a patient the softness of the puff and alleviate any apprehension 13 14 15 16 OD OS button Menu Change button This toggles between recording data for the left or right eyes This button also is used to toggle through the menu options when in menu mode refer to section 17 for full instructions Eyepiece The Eyepiece allows the user to view the patient s eye and align the targeting system Puff tube and lens The puff tube and puff lens is the part of the Pulsair intelliPuff
12. l When the bow tie image appears Pulsair intelliPuff takes a subsequent reading When two successive readings within 1mmHg of each other are recorded a sound may be emitted if sounds are enabled in the menu settings If successive readings of within 1mmHg of each other are not obtained Keeler recommend taking up to four readings Continued on next page Keeler Home Back Next Taking the reading 9 When two consecutive readings are within 1mmHg an audible sound will be heard indicating that sufficient readings may have been taken 10 If a reading is recorded as a non event or bad event a bad event long high pitch tone will be heard 11 The first reading will be the measured value successive readings will display the running average IOP Outlying or spurious readings will automatically be excluded from the calculation 12 At any time the review button will allow you to view the individual readings 13 If the unit does not fire repeat step 3 7 To measure the other eye press the OD OS button on the hand unit and repeat processes 3 7 Keeler Home Back Next Display examples The unit will display STBY when power is on The unit will display wait for one second while the system initialises When no fault is found OK is displayed and the unit defaults to measure the right eye OD Shows first reading of 14mmHg The LED OD OS indicator shows which eye the reading relates to
13. ng and instructions indicates that it was put on the market place after August 2005 and ME that this product shall not be treated as Household Waste C 3 0088 EP59 70004 Issue B USA Sales Office Keeler USA 456 Parkway Broomall PA 19008 USA Toll Free 1 800 523 5620 Tel 1 610 353 4350 Fax 1 610 353 7814 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 If you need more information on the collection reuse and recycling then please contact B2B Compliance on 01691 676124 44 1691 676124 Keeler Home Back
14. roduct The Keeler Pulsair intelliPuff is an air puff Tonometer designed to accurately measure Intra Ocular Pressure IOP without making contact with the surface of the eye Air impulse tonometry is a variant of the general applanation tonometry in which a portion of the cornea is flexed by mechanical stimuli in which the force pressure required to produce the flexing effect is related to the intraocular pressure The air puff technique requires directing a calibrated quantized packet of air towards the central portion of the cornea and the detection of the pre defined deformation of the cornea through optical means and reflections from the corneal surface Please read and follow these instructions carefully Keeler Home Back Next Introduction Thank you for purchasing the Keeler Pulsair intelliPuff The product has been designed and manufactured to ensure that you will enjoy many years of trouble free and safe use Please follow the User Instructions to ensure optimum performance Keeler Home Back Next Symbols A Read user instructions for Warnings Cautions and additional information C 4 The CE mark on this product indicates it has been 0088 tested to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive o Double insulated Type BF protections against shock Keeler Home Back Next Warnings and cautions AN Warning e Do not use if the produ
15. sometimes be misleading as the IOP will vary as a result of pulse respiratory and diurnal fluctuations In addition blinking squeezing fluid intake physical activity body position and even the direction of gaze can influence IOP Up to 4 readings may be required in order to reduce the impact of these variants to a constant IOP Pulsair intelliPuff software will recognise the readings and give a sound notification when two consecutive readings are 1mmHg of each other indicating that further measurements may not be required Home Keeler Back Next Names of controls and components 1 On off push button 7 Forehead rest To turn the intelliPuff on push the on off button Push to release or push to return the a green LED will indicate the unit is on forehead stabiliser to its discrete position To turn off the intelliPuff push the on off button the green LED will go out 8 Right OD Left OS indicators These will indicate the eye to be measured the OD OS button will toggle between these indicators 2 Test eye This is useful for user training it will not return an IOP measurement 3 Printer active LED When lit this indicates the printer is activated replacing the handset in the cradle will force a print Alternatively a print can be forced at any time using the print button on the handset 4 Printer cover Access to the printer paper is via this cover use your finger in the lip on the top of
16. ssing the MENU print button will move you forward to 5 Use the CHANGE OD OS button to make your preferred selection Note to run the self test press the DEMO button not the CHANGE button The last choice above Run Test 6 Continue to repeat steps 4 and 5 until OK is displayed your Pulsair intelliPuff is now ready to use with your preferred settings Selected by pressing Demo button would start a self test program around 45 seconds the result of Menu option Display Change options which should be printed Printer control PRNT OFF ON Buzzer control BUZ ON OFF MENU DEMO BUTTON intelliPuff level PUFF CLIN clinical AUTO Keeler IOP Format IOP XX XX X Full self test RUN TEST WAIT Home Back Next CHANGE Calibration maintenance and inspection Clean the puff tube lens on a weekly basis 1 Moisten a cotton bud with Isopropyl Alcohol 2 Move the tip of the bud around the lens in a circular motion 3 After one circle the bud should be discarded to avoid smearing on the lens 4 Look at the puff tube lens from the patient s side if traces of tear film can still be seen repeat above steps until clear Note Care should be taken not to damage the Puff Tube assembly during cleaning AN Caution 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 External cleaning Keep the unit free of dust
17. through which the Pulsair is aligned and a gentle puff of air is emitted Alignment LEDs The two green LED s located on the front of the hand unit Keeler Back Next act as a guide when you are lining up the patients eye to take a reading Home Measurement procedures Prepare the device 1 Plug in the power supply cord to the instrument The power socket is located at the rear of the instrument 2 Turn the instrument on using the on off push switch located on the front of the instrument 3 Lift the handpiece from the cradle 4 Remove the red protective dust cap from the puff tube 5 When the hand unit is removed from the holster the two green LED s on the front illuminate and the pump starts the intelliPuff will perform a system check when complete the display will read OK refer to section 14 for a full list of display data 6 Before using the Pulsair intelliPuff press the Demo button to dispel any minute particles of dust or moisture which may have settled whilst the Pulsair intelliPuff was not in use 7 Align the handpiece with the patients cornea the Pulsair will automatically fire when correctly aligned Pull seated with the pabeary head supported 1 Press to release the forehead rest Al appecuimately Sdcms 12 inches look Teough the wnetiPull eyepiece at the patents eye 3 Slowly move towards the patient eye keeping the cornea centred 4 amp As you approach Some 2 in
18. urce during the previous 24 hours This will apply particularly if the eye has been subjected to retinal Photochemical cores Radiance photography source radiance mW cm sr Aphakic LA 305 700nm Red LED Thi li th EN 1 1 2 for EM houl Note This device complies wit 6060 or EMC and should Phakic LB 380 700nm Red LED not present problems to other equipment or be affected by other i o o Aphakic LA 305 700nm Green LED devices As a precaution avoid using this device in close proximity Phakic LB 380 700nm Green LED to other equipment Table 2 Calculated photochemical source radiances Keeler Home Back Next Accessories Accessories supplied Dust cover Printer paper Puff tube dust cap Wall mounting bracket User manual printed CD depending on market Quick user guide pull out card Consumable Printer paper Home Keeler Back Next Contact Information Manufacturer Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA Freephone 0800 521251 Tel 44 0 1753 857177 Fax 44 0 1753 827145 Scotland Sales Office Keeler Scotland 25 Deerdykes View Westfield Estate Cumbernauld G68 9HN Freephone 0800 521251 Tel 44 0 1236 721214 Fax 44 0 1236 721231 Disposal of old Electrical and Electronic Equipment Applicable in the European Union and other European Countries with separate Collection Systems xt This Symbol on the Product or on its Packagi
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