occuity PM1 Handheld Ophthalmic Pachymeter Instruction Manual

occuity PM1 Handheld Ophthalmic Pachymeter

Product information

The Occuity PM1 is a handheld ophthalmic device designed for measuring Central Corneal Thickness (CCT) quickly and accurately. The device utilizes advanced technology to align with the center of the eye and automatically initiate scanning. By capturing data hundreds of times per second, the PM1 calculates a precise CCT measurement.

The PM1 comes with a cradle for charging and a power supply suitable for both UK and EU outlets.

Product Usage Instructions

Set up

1. Remove the PM1 and its accessories from the case, taking note of any safety warnings.
2. Connect the cradle to the provided power supply.
3. Plug the power supply into a mains outlet.
4. Place the PM1 on the cradle to fully charge the battery.

Security Intended Use:
The PM1 is safe to use according to the specified methods of operation. Any deviation from these methods may pose a danger to the patient or operator. Modification or servicing of the equipment should only be done by Occuity.

Contact Lenses:
Before using the PM1, patients should remove their contact lenses to ensure accurate CCT measurements.

Laser Safety:
The laser aperture of the PM1 should not be directed toward any material that may overheat or ignite. Operating the device in ways other than specified may result in hazardous radiation exposure. Prolonged exposure to the emitted light can cause ocular damage, and maximum intensity operation should not exceed 15 minutes or 100 measurements per person per day.

Charging Safety:
Avoid simultaneous contact with the patient and the USB connector. Position the cradle at least 1.5 meters away from the patient. Only use the provided power supply with the cradle, as alternative power supplies may void the warranty and pose a danger. The PM1 should only be charged using the provided cradle, and it cannot be used for measurements while charging. It is normal for both the PM1 and the cradle to become warm during charging and operation. If the rechargeable battery inside the PM1 degrades and it becomes unchargeable, contact your local distributor or visit occuity.com/support.

Electrical Safety:
Do not operate the PM1 if it is known or suspected to be damaged. Tampering with or removing any part of the device or its accessories will void the warranty. Only use accessories, transducers, and cables provided with the PM1 to avoid electromagnetic emissions or decreased electromagnetic immunity. If the PM1 needs to be used adjacent to or stacked with other equipment, it should be tested to ensure normal operation. Portable RF communications equipment should be kept at least 30 cm away from any part of the PM1 to prevent performance degradation.

Introduction

• Occuity PM1 is a handheld ophthalmic device that quickly measures Central Corneal Thickness (CCT), without the need to touch or anaesthetise the eye.
• It uses advanced technology to help the operator align to the center of the eye and automatically begin scanning.
• PM1 captures data hundreds of times per second before calculating a precise CCT measurement.

Setup

1. Carefully remove PM1 and its accessories from the Case and observe safety warnings
2. Connect the Cradle to the Power Supply provided
3. Connect the Power Supply to the mains outlet
4. Place PM1 on the Cradle and fully charge the battery

Safety

Intended use
PM1 is intended to be used only by healthcare professionals in a professional environment to measure the Central Corneal Thickness (CCT) of the eye for aiding the assessment of:

• Intraocular pressure (IOP) for glaucoma assessment
• Pre, during and post-surgical assessment including LASIK, LASEK or intra-ocular lens exchange treatments
• Screening for conditions including keratoconus (through assessment of corneal ectasia) or Fuchs’ endothelial dystrophy

General safety
PM1 is safe to use under the indicated methods of operation, which should not be deviated from. Failure to comply may pose a danger to the patient or operator.

Warning
No modification of the equipment is allowed. The equipment can only be serviced by Occuity. Contact your local distributor or visit occuity.com/support.

Before PM1 is used, patients should remove contact lenses to prevent inaccurate CCT measurements from being reported.

Laser safety

PRECAUTION

• PM1’s laser aperture should not be directed at any material that might easily overheat or ignite.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
• The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 15 minutes or 100 measurements per person per day.

Charging Safety

Warning

• Do not touch the patient and the USB connector simultaneously.
• Position the Cradle at least 1.5 m from the patient. The Cradle must only be powered by the Power Supply provided. The use of an alternative power supply will void the warranty and may be dangerous.
• PM1 must only be charged using the provided Cradle. While PM1 is charging, it cannot be used to take a measurement. During charging and operation, it is normal for PM1 and the Cradle to be warm.
• The rechargeable battery inside PM1, like all lithium-ion batteries, will lose capacity over time. If PM1 is no longer chargeable due to battery degradation, contact your local distributor or visit occuity.com/support.

Electrical safety

Warning:

• Do not operate PM1 if it is known or suspected to be damaged.
• Tampering with or removing any part of PM1 or its accessories will void the warranty. There are no user controls or user-serviceable parts inside PM1.
• The use of accessories, transducers and cables not provided with PM1 may result in electromagnetic emissions or decreased electromagnetic immunity.
• PM1 should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, PM1 should be observed to verify normal operation in the configuration in which it will be used. Portable RF communications equipment should be used no closer than 30 cm to any part of PM1, otherwise, PM1’s performance may be degraded.
• PM1 is a precision electronic optical instrument. Reasonable care should be taken when making an electrical connection and handling all electronic devices.
• To isolate PM1 from mains power, unplug the Power Supply. Position the Cradle so that the Power Supply remains accessible. It is recommended that the Power Supply is inspected for electrical safety annually.

Equipment safety

Warning:

• PM1 provides no explosion protection from static discharge or arcing components.
• Do not operate the product in the presence of explosive gases such as flammable mixtures of anesthetic and oxygen, or nitrous oxide.
• No peripheral equipment should be connected to PM1. It should only be used in conjunction with Occuity-accredited accessories.
• Always take care when handling PM1 to avoid accidental damage. Use the provided Case to transport PM1 and its accessories. Do not allow PM1 to get wet.
• PM1 does not require calibration.

Standard operating conditions
PM1 must be used within the specified limits.

• Temperature 10 to 35 OC
• Relative Humidity 30 to 80 %
• Pressure 800 to 1060 hPa

Features

Taking a measurement

1. Press the power button to turn on PM1
2. Ask the patient to look straight ahead, then press Start
3. Align PM1’s viewfinder to the reflection in the centre of the eye
4. Wait until the Progress ring is complete PM1 will play a sound as it collects data
5. Repeat steps 2 to 4 twice to calculate the mean measurement
6. Hold the power button to turn off PM1

Using PM1

Statistics

• If statistics are enabled in Settings, PM1 will show additional data to assist with the clinical interpretation of the measurements.
• When statistics are shown, PM1 will retain measurements that are not recommended for use. Press Delete to remove individual measurements.
  • An accurate measurement is close to the true value
  • A precise measurement is made of consistent data

Settings

Verification
After inactivity, change in environmental conditions or impact shock, PM1 may request verification in the Cradle.

• Place PM1 in the powered Cradle to initiate verification. Ensure there are no obstructions between PM1’s laser aperture and the Cradle’s reference artefact, and that both optical surfaces are clean.
• If PM1 is only reporting measurements that are not recommended for use, verification can be manually started from Settings to confirm PM1’s functionality.

Alignment override
After pressing Start measurement, PM1 projects a ring of light onto the eye and uses it to detect alignment before laser scanning. In the presence of bright ambient light, PM1 may not be able to detect the projected ring of light.

To override alignment detection, press and hold the Start measurement button for 3 seconds to begin laser scanning.

Sleep
After 20 seconds of inactivity, the touchscreen will turn off and PM1 will enter sleep mode. Tap the touchscreen to wake PM1. After 20 minutes of inactivity, PM1 will turn off automatically.

Display symbols

Troubleshooting

PM1 does not turn on
Check PM1 is charged by placing it on the Cradle. Turn PM1 off by holding the power button, then press the power button again. Check for damage and that the operating conditions are acceptable.

PM1 does not charge when placed on the Cradle
Ensure the Cradle is connected to the correct Power Supply, powered at the mains outlet, and PM1 is sat correctly.

PM1 takes longer than usual to turn on
PM1 is tuning its scanning system to the surrounding environment to ensure functionality.

PM1’s charging indicator is flashing
PM1 is experiencing a charging issue. Remove PM1 from the Cradle and ensure it is within acceptable environmental conditions. Ensure PM1 and the Cradle are free from obstuctions.

PM1 is reporting measurements that are not recommended for use
Move PM1 and the patient away from bright light sources. Ensure the patient stays still and looks straight ahead. Use both hands to stabilise PM1. If required, touch the patient’s forehead with the second hand to improve stability, ensuring local infection control procedures are followed. Ensure PM1 is aligned to the center of the reflection in the eye until the Alignment ring turns green.

PM1 has failed verification
Ensure there are no obstructions between PM1’s laser aperture and the Cradle’s reference artefact, and that both optical surfaces are clean. Check PM1 and the Cradle are free from visible damage. Ensure the Cradle is placed on a steady surface and that PM1 is not being handled during verification.

Cleaning

• PM1 is designed to avoid contacting the patient. Cleaning should be performed according to local clinical protocols and is recommended between patients to avoid cross-contamination.
• To clean the enclosure of PM1 and the Cradle, only use a 70% isopropyl alcohol wipe. Allow PM1 and the Cradle to dry before use. Other cleaning products may damage the plastic enclosure.
• Only clean PM1’s glass laser aperture using a lint-free lens cloth. Check the laser aperture is free from residue before use. Only clean the Cradle’s reference artefact using a lint-free lens cloth.
• Do not touch the patient unless adequate PPE and infection control measures have been implemented.

Specifications

• Model PM1 · 5065007477007 EU
• Device type Pachymeter
• Device overall dimensions 17.5 x 15 x 4.5 cm
• Mass 345 g
• Laser safety class (BS EN 60825-1) Class 1
• Laser wavelength 1310 nm ± 20 nm
• Laser power 30 μW (nomimal)
• Measurement units μm
• Recommended patient age group ≥ 6 years old
• Corneal thickness range measured 300 to 800 μm
• Measurement accuracy ± 10 μm
• Measurement precision ± 5 μm
• Measurement resolution 1 μm
• Scanning range < 5 mm
• Scanning frequency 100 Hz
• Scanning time Up to 10 s
• Minimum working distance 16.5 mm from aperture
• Charge time Up to 4 hours
• Power supply model GlobTek GTM46101-1005-USB
• Power supply input requirements 100 to 240 V AC at 50/60 Hz
• Battery type Li-ion · 7.4 V · 1050 mAh
• Auto power-off when idle 20 minutes
• Enclosure material Polycarbonate
• Diffuser material Acetal copolymer
• Rated product life 3 years

Environmental limits

Storage

• Temperature -10 to 55 OC
• Relative Humidity 30 to 80 %
• Pressure 800 to 1060 hPa

Transport

• Temperature -20 to 60 OC
• Relative Humidity 10 to 80 %
• Pressure 800 to 1060 hPa

Device labelling

• CE mark, notified body 1912
• Subject to WEEE Directive
• Manufacturer
• Date of manufacture
• Serial number
• European representative
• Medical device

Important Information

Regulatory compliance

PM1 is designed to comply with:
IEC 60601-1:2006 Medical Electrical Equipment BS EN 15004-1:2007 Ophthalmic Instruments BS EN 60825-1:2014 Safety of Laser Products EU MDR 2017/745 Medical Device Regulation

Laser classification

• Class 1 laser product (BS EN 60825-1:2014 + A11:2021)
• Group 1 ophthalmic instrument (BS EN 15004-2:2007)

Declaration

PM1 is intended for use in the electromagnetic (EM) environment specified. The user of PM1 must ensure that it is used in the correct environment. Hereby, Occuity declares that the radio equipment type PM1 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at occuity.com/legal.

Emissions
As per IEC 60601. PM1 is intended for use in professional healthcare environments, such as High Street Optometrists, including those directly connected to the public low-voltage power supply network. PM1 is not intended for use in high electromagnetic field environments such as near HF Surgical Equipment, or outside the RF-shielded room of magnetic resonance imaging systems.

The Cradle uses RF energy to charge PM1. It uses frequency and backscatter modulation within the 110-205 kHz band and the effective radiated power is <8 W. PM1 must emit electromagnetic energy to perform its intended function.
In the unlikely event that PM1 interacts with other electronic equipment, measures should be taken to minimise interference, such as relocation.

EM compatibility compliance

• RF Emissions (CISPR 11)
  • Group II
  • Class B
• Harmonic emissions (IEC 61000-3-2) Compliant
• Voltage fluctuations emissions (IEC 61000-3-3) Compliant
• Electrostatic Discharge immunity (ESD) (IEC 61000-4-2)
  • ± 8 kV contact
  • ± 15 kV air
• Radiated RF field immunity (IEC 61000-4-3) 3 V/m
• Power frequency magnetic field immunity (IEC 61000-4-8) 30 A/m
• Proximity magnetic fields immunity (IEC 61000-4-39)
  • 13.56 MHz 7.5 A/m
  • 134.2 kHz 65 A/m
• Fast transients immunity (IEC 61000-4-4) ± 2 kV
• Surge immunity (IEC 61000-4-5)
  • ± 1 kV line-to-line
  • ± 2 kV line-to-ground
• Voltage dips and interruptions (IEC 61000-4-11) Compliant
• Conducted RF field immunity (IEC 61000-4-6)
  • 3 V/m
  • 6 V/m in ISM bands

Disposal
PM1 contains electronic components. At the end of its shelf life, it must be properly disposed of in compliance with local regulations. EU directives and national regulations prohibit the disposal of PM1 in domestic waste or by municipal waste disposal companies. Contact your local distributor or visit occuity.com/support for the latest advice on how to recycle PM1.

Complaints
In the unlikely event of needing to make a complaint about PM1, contact your local distributor, or email [email protected].

If during the use of this device you believe a serious incident has occurred, report it to Occuity Ltd. and the competent local authority.

Support
For support and warranty claims, contact your local distributor or visit occuity.com/support

Warranty

Occuity Ltd. warrants its new equipment to be free from defects. Any device that is proven to be defective will be repaired or replaced, at Occuity Ltd.’s discretion, free of charge, up to one year from the date of purchase, unless otherwise governed by local legislation or an extended warranty has been purchased. This warranty covers all repairs and servicing of parts that prove defective due to manufacturing. This warranty does not apply to any defect that is the result of an accident, misuse, mishandling, neglect, improper repair, or improper modification unless by authorised technicians of Occuity Ltd.

Occuity news
For Occuity product announcements and updates, subscribe at occuity.com

Legal
‘Occuity’, ‘PM1’ and the fiducial logo are registered trademarks of Occuity Ltd. They may not be reproduced without the written permission of Occuity Ltd.

• European Healthcare & Device Solutions (Ireland) Ltd, Stratton House, Bishopstown Road, Cork, T12 Y9TC, Ireland europeandevicesolutions.eu
• Occuity Ltd, The Blade, Abbey Square, Reading, RG1 3BE, UK occuity.com.

Retain this document for future reference.

References

• Optical Healthcare Monitoring And Screening | Occuity
• Optical Healthcare Monitoring And Screening | Occuity
• Support | Occuity

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