Haag-Streit Perkins Mk3 Instruction Manual
Perkins Mk3
Hand-Held
Applanation Tonometer
Instruction Manual
Please read these instructions
before using the equipment
CLEMENT CLARKE
OPHTHALMIC
!
0120
en
Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.1 Technical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2a Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2b Purpose for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3 Brief Description of the Appliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. General Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4/5
3. Safety and Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1 Safety Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3.2 Measuring Prism Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.4 Notes on Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.5 Statutory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.6 Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.7 Regulatory Information: CE Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.7.1 Waste Electrical Electronic Equipment (WEEE). . . . . . . . . . . . . . . . . . . . 10
3.8 Environmental Conditions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
3.9 EMC (Electromagnetic Compatibility) Declaration. . . . . . . . . . . . . . . . . . . 11
3.10 Product Labelling and Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.11 Safety Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4. Taking a Pressure Measurement . . . . . . . . . . . . . . . . . . . . . . . . . .13/14
5. To Prepare the Prism for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.1 Remove Perkins Mk3 Tonometer From Case . . . . . . . . . . . . . . . . . . . . . . 15
5.2 Doubling Prism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.3 To Insert Prism into Prism Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5.4 Tonosafe Disposable Prism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6. Operating the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.1 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.2 Instruction to the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
7. Cleaning the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
8. General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
8.1 Astigmatism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
8.2 To Use the Instrument on Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.3 Special Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
9. Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9.1 Sources of Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
9.2 Inaccurate Horizontal Centering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
9.3 Inaccurate Vertical Centering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
9.4 Inaccurate Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
10. Case Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
11. Calibration Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
12. Storage of Prism and Tonometer . . . . . . . . . . . . . . . . . . . . . . . . . 29
13. Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
14. Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
15. Charger Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
16. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
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1. Introduction
We would like to thank you for your decision to purchase this CLEMENT CLARKE product.
If the instructions in this manual are carefully followed, we are confident that this product will
give you reliable and trouble-free usage.
We will be forced to disclaim any warranty and liability if the instrument is altered in any way
or if routine maintenance is neglected or not carried out according to factory specifications.
Only original CLEMENT CLARKE accessories are to be used to ensure continued reliability of
the instrument.
Following the popular Mark 2 Perkins tonometer, comes the technically advanced and well
designed Mark 3 model. Its improved LED illumination and convenience are some of the
many features which maintain the reputation of Perkins hand-held instruments in the
forefront of tonometry.
Because the Perkins tonometer is capable of being used in all positions, the mass of the
Goldmann doubling prism must be controlled accurately. Only HAAG-STREIT prisms
should be used or the disposable Tonosafe prism can be used to prevent cross-infection.
Any other prisms may give a false reading if used in the Perkins tonometer.
1. 1 Technical Description
A pair of spiral wound flat springs connected in series are progressively tensioned by rotation
of the operator’s calibrated thumb-wheel. The resulting force stored in the spring is
transmitted through a balanced arm to the applanation doubling prism or the Tonosafe prism
mounted at its end.
The tonometer is fitted with two cobalt blue LEDs, (wavelength 450-490nm) to provide
illumination. These are powered by a 3.6V, 280 mAh Ni-Mh rechargeable battery.
The LED meets the requirements for a Class 1 LED product to IEC/EN 60825-1 (2001) under
normal operating conditions and those of single fault failure.
The battery charger conforms to Class II insulation and has also been tested to EN60601
and UL60601-1.
This equipment is designed and manufactured to be as safe as is reasonably practicable
when installed and used correctly by persons qualified to do so in accordance with the
manufacturer’s instructions. Any misuse, incorrect assembly or installation could result in
the equipment becoming unsafe. It must not be repaired except by competent
persons under the manufacturer’s instructions.
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2. General Layout
Fig 1
1 Forehead rest
2 Forehead rest locking screw
3 Forehead rest stem
4 Prism holder
5 Doubling prism
6 Illumination LEDs
1
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6
5
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2. General Layout - continued
Fig 2
7 Viewing lens
8 Milled thumb-wheel
9 Scale
10 Tonogrip (Cone arm securing buttons)
11 Battery Indicator
12 Charging Port
8
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7
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3. Safety and Regulatory Information
3. 1 Safety Notices
No user serviceable parts inside.
Do not open the Tonometer case moulding under any circumstances.
Caution: In the event of any malfunction, contact your local distributor or
visit our website to contact us directly.
Use only the charger supplied with the device.
The operator should not touch the accessible charger connector and the
patient simultaneously.
This product is intended for indoor use only.
This product is not suitable for operation in the presence of a flammable
anaesthetic mixture with air or with oxygen or with nitrous oxide.
Not protected against the ingress of water or other fluids.
“Warning: No modification of this equipment is allowed”
The following instructions should be observed to ensure
the safety of patients:
Avoid examinations in cases of eye infections or injured corneas
• There is no known contraindication for performing tonometry. Medical assessment
is necessary and due care is to be exercised in cases of eye infections and injuries
to the cornea.
Only clean and disinfected measuring prisms should be used
• Examinations should be conducted with cleaned and disinfected measuring
prisms.
• Tonometer prisms are not dispatched in a disinfected state and should always be
disinfected before use.
• The disinfecting of contact glasses e.g. with cotton wool or a damp cloth without
putting them into disinfecting fluid is insufficient and should not be allowed.
3. Safety and Regulatory Information
- continued
No damaged prisms should be used
Before each use the contact surface of all prisms should be checked for
contamination or damage (such as scratching, rips or sharp edges).
A slit lamp microscope or Loupe is best used for this purpose, at a magnification
of 10x to 16x.
• If cracks form, the disinfectant may get into the hollow interior and can enter the
patient’s eye while tonometry is taking place, leading to irritation of the cornea.
Defective measuring prisms should not be used, to avoid any damage to the
patient’s cornea.
3. 2 Measuring Prism Replacement
• Due to the number of variables involved - type and concentration of disinfecting
material used, number of patients, handling etc. - it is almost impossible to put a
figure on the number of times and/or period of time that a measuring prism can
safely be used for.
• Our experience, and that of our users, indicates that under ‘normal’ usage (i.e. as
per the instructions contained within this instruction manual) a maximum of two
years provides an adequate safety factor.
• HAAG-STREIT therefore recommend strongly that no measuring prism is used
beyond two years from it’s date of first usage (a measuring prism may be retained
as a spare indefinitely - deterioration does not start until it is first used).
• The recommended time is overruled if the prism is in any way damaged within
this time period - damaged prisms should be immediately discarded.
7
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• Incorrect medical disinfecting can cause patients to be infected and can also
cause damage to the eyes.
• Residue from the disinfecting may cause a caustic reaction to the patients eye,
therefore rinse throughly.
Applied Parts
Tonosafe Disposable Prism
Goldmann Doubling Prism
Head Rest
8
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3. Safety and Regulatory Information
- continued
3. 3 Transportation and Storage
• The Applanation Tonometer conforms to ISO 15004-1:2006 for Storage and
Transport Conditions and should always be stored in its carry case when not
in use.
Transport Conditions
Temperature: -40˚C to +70˚C
Relative Humidity: 10% to 95%
Atmospheric Pressure: 500hPa to 1060hPa
Vibration, Sinusoidal: 10Hz to 500Hz: 0.5g
Shock: 30g, duration 6 ms
Bump: 10g, duration 6 ms
Storage Conditions
Temperature: -10˚C to +55˚C
Relative Humidity: 10% t0 95%
Atmospheric Pressure: 1060hPa
• The Applanation Tonometer should be checked for damage after unpacking.
• Defective equipment should always be returned in appropriate packaging.
• The equipment may only be operated with the listed accessories (see page 33)
according to the corresponding operating instructions.
• The battery charger is exempt from the above standard but has been tested for
Transport Conditions only within the carry case.
3. 4 Notes on Usage
• Only qualified and trained personnel may operate the equipment.
• The training of the operating personnel is the responsibility of the equipment user.
• This type of sensitive measuring equipment should be checked after exposure
to external force (e.g. unintentional shocks or being allowed to fall) and if
necessary, should be returned to the manufacturer for repair.
• The manufacturers of the equipment will not be liable for any loss or damage
resulting from unauthorized intervention.
In particular, it is forbidden to loosen any screws; this may reduce the accuracy
of the measurement. All ensuing warranty claims will be deemed null and void as
a result of unauthorized intervention.
• The Perkins Mk3 should not be used while connected to the battery charger.
9
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3. Safety and Regulatory Information
- continued
3. 5 Statutory Requirements
• The Applanation Tonometer is designed as a Class IIa device under the Medical
Device Directive 93/42/EEC.
• The Applanation Tonometer complies with the Tonometer regulation
ISO 8612:2009 & ISO 15004-1: 2006.
3. 6 Caution
• The safety regulations displayed in the operating instructions are to be
observed with special care.
Caution
Strictly observe all warning notices!
3. 7 Regulatory Information: CE-Mark
The products fulfil the requirements according to the following
standards:
Safety: EN60601-1 Part 1: General Requirements for Safety,
Medical Electrical Equipment
Electrical: EN60601-1-2 Part 2: Collateral Standard: Electromagnetic
Compatibility
Infrared: EN60825-1 Part 1: Safety of Laser Products: Equipment
classification requirements
10
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3. Safety and Regulatory Information- continued
3. 8 Environmental Conditions of Use
Temperature: +10ºC to +35ºC
Relative Humidity: 30% to 90%
Atmospheric Pressure: 800hPa to 1060hPa
Shock ( without packing): 10g, duration 6 ms
3. 7.1 Waste Electrical Electronic Equipment (WEEE)
End of Life and Disposal
The battery may contain toxic or hazardous material and must be disposed of as
Waste Electrical Electronic Equipment (WEEE).
For all applicable devices under the WEEE directive, which have reached their end
of life, please contact Haag-Streit customer services on 01279 414969, who will
instruct you how to return the device for disposal.
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