Keeler Pulsair intelliPuff User manual

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Instructions for use

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Contents
1. Copyright and Trademarks ........................................ p3
2. Introduction ............................................................... p4
3. Symbols ...................................................................... p5
4. Safety .......................................................................... p6
4.1 Device Classification ............................................ p6
4.2 Warnings and cautions ....................................... p6
5. Cleaning instructions ................................................. p7
6. Power supply assembly ............................................. p8
7. Wall mounting ........................................................... p9
8. Tonometry pressure variations in the
human eye ............................................................... p10
9. Names of controls and components ...................... p11
10. Measurement procedures ....................................... p15
10.1 Preparing the device ....................................... p15
10.2 Preparing the patient ...................................... p16
10.3 Taking the reading .......................................... p17
11. Display examples ..................................................... p19
12. Printing .................................................................... p20
13. Replacing the printer paper ................................... p21
14. User menu options .................................................. p22
15. Calibration, maintenance and inspection .............. p23
16. Specifications and electrical ratings ...................... p25
17. Accessories and warranty ........................................ p31
18. Contact, packaging and disposal information ...... p32
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As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.

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1. 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 2009.
Description of the product
The Pulsair intelliPuff Non-Contact Tonometer is indicated for
measuring intraocular pressure without contacting the eye to aid
in the screening and diagnosis of glaucoma.
It 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.

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2. 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.

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3. Symbols
Read user instructions for Warnings, Cautions and
additional information
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
Double insulated
Type BF protections against shock
Consult instructions for use
Manufacturers name and address
Keep dry
0088
Power input port
On/Off
Fragile
This way up
Material suitable for recycling

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4. Safety
4.1 Device Classification
CE Regulation 93/42 EEC: Class 2a
FDA: Class II
4.2 Warnings and cautions
Warning
• Do not use if the product is visibly damaged and periodically
inspect for signs of damage.
• Do not use in the presence of flammable gases.
• This product should not be immersed in fluids.
• Do not fit mains power adapter into a damaged mains
outlet socket.
• Route power cords safely to eliminate risk of tripping or
damage to user.
• USA Federal law restricts this device to sale by or order of a
physician.
• Only use approved Keeler power supply EP29-32777
or instrument may malfunction.
• Do not remove the labels covering the key holes unless wall
mounting the Pulsair intelliPuff.
Caution
• The product has been designed to function safely when at an
ambient temperature between +10ºC and +35ºC.
• This product should be used in a room with subdued lighting.
• Keep out of the reach of children.
• 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 recommended that these factors are
considered during IOP measurement.
• To prevent condensation from forming, allow instrument to
come to room temperature before use.
• Only mount on wall according to Keeler Instructions.
• Before using the Pulsair intelliPuff, press the Demo button
to dispel any minute particles of dust.

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5. 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-
shedding cloth.
d Safely dispose of used cleaning materials.

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6. 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).
IEC 60320 TYPE 7 connector

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7. 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. Remove labels covering the key holes.
7. Carefully locate the mounting pegs of the plate to the key
holes on the back of your Pulsair intelliPuff and allow the
Pulsair be lowered into its final and secure position.
Remove labels
Remove labels
Remove labels

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8. 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 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.

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1. On off push button
To turn the intelliPuff on, push the on off button –
a green LED will indicate the unit is on.
To turn off the intelliPuff, push the on off button –
the green LED will go out.
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 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
Insert the low voltage power lead (located on rear of instrument)
use only Keeler power supplies.
7. Forehead rest
Push to release, or push to return the
forehead stabiliser to its discrete position.
8. Right (OD) / Left (OS) indicators
These will indicate the eye to be
measured; the OD/OS button will
toggle between these indicators.
9. Names of controls and components
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9. Names of controls and components
9. Display
The display shows the recorded IOP reading and the averaged
IOP reading.
After the first reading is taken the display shows the measured
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 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 figure of 15.7, or 16 depending on
user settings.
When all the required readings have been taken the figure
displayed is the IOP that is recorded for the patient.
When two consecutive readings are within 1mmHg an audible
sound will be heard indicating that sufficient readings may
have been taken.
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9. 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 user
menu and sub menu functions. Refer to page 22
for full instructions on the user menu options.
11. Review button / Easy pulse button
The ‘R’ review button is dual function:
• Review It allows the reader to review readings taken.
• Easy Pulse mode In the event of difficulties in firing,
for example with a damaged or scarred cornea, it will
override the firing parameters to ease taking the
measurement.
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.
To initiate Easy Pulse mode hold the review button
for greater than one second; the display will show
‘easy’, it will beep once and the unit will be ready
to use on the difficult eye. Pressing any button,
returning the handpiece to the cradle or
performing a manual reset by pressing the
button in the cradle well will return the
intelliPuff to it’s previous settings.
12. Demo button
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.
13. 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 page 22 for full instructions on
the user menu options.
14. Eyepiece
The Eyepiece allows the user to view
the patient’s eye and align the
targeting system.

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9. Names of controls and components
15. Puff tube and lens
The puff tube and puff lens is the part of the Pulsair intelliPuff
through which the Pulsair is aligned and a gentle puff of air is
emitted.
16. Alignment LEDs
The two green LED’s located on the front of the hand unit act
as a guide when you are lining up the patient’s eye to take a
reading.
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10. Measurement procedures
10.1 Preparing 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
13 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.
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10. Measurement procedures
10.2 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 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.

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10. Measurement procedures
10.3 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.
2. Lift the hand unit, the pump starts and the two green LED’s
illuminate.
3. From a distance of about 30 cms (12 inches), look
through the eyepiece and locate the patient’s eye.
4. Slowly move closer to the patient, maintaining
alignment. Support the Pulsair intelliPuff against your
free hand and/or use the ‘pop out’ forehead stabilizer.
5. Continue to move in slowly towards the patient,
two green dots appear.
6. Continue to move closer, a red reflex appears.
7. 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.
8. Once you have taken a reading, remain in the operating position;
wait a few seconds for the air chamber to refill. 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

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Pull out short form
instructions
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.
10. Measurement procedures
10.3 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.

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11. Display examples
The unit will display STBY when power is on.
The unit will display ‘wait’ for one second while the system initialises.
When a pressure (IOP) of greater than 25mmHg is detected, the
unit will display >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.
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.
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.
Display shows error.
(Signified by a long high pitch sound).

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12. 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.
The average IOP is printed to one decimal place ‘xx.x’.
The last four individual readings are printed to zero decimal
places ‘xx’.
Name:
Date:
Time:
Right Eye:
Avg IOP: 10.4 mmHg
Data: (20), 10, 10, 10
Left Eye:
Avg IOP: 10.5 mmHg
Data: 10, 11, 10, 10