The Keeler All Pupil II is an indirect ophthalmoscope designed for examining the cornea, aqueous, lens, vitreous, and retina of the eye. It is an AC or battery-powered device containing illumination and viewing optics, intended for use by suitably trained and authorized healthcare professionals. The device is head-mounted for user convenience.
Function Description
The All Pupil II allows for a comprehensive examination of the ocular fundus. While it can be used through an undilated pupil, pupillary dilation using mydriatics is recommended for a wider field of view and better magnification. For a more peripheral view of the retina, scleral indentation can be performed as an adjunct. The device features a Filter Selector Bar (M) with three selectable filters:
- Red-free filter: Increases contrast for assessing changes in fine vessels, such as retinal hemorrhages.
- Cobalt Blue filter: Used with fluorescein dye for detecting and examining corneal scars and abrasions.
- Diffuser: Provides an extra-wide beam of diffused light for a more relaxed technique during challenging fundus examinations.
The instrument also provides protection from UV/IR radiation.
Important Technical Specifications
All Pupil II (General):
- Input mains data: 100-240V ~ 50/60Hz
- Power supply rating: 12V: 2.5amps
- Operation: Continuous
- Classification: Class II equipment, Type B applied part
- Environmental Conditions (Use):
- Temperature: 10°C to 35°C
- Humidity: 30% to 90%
- Atmospheric pressure: 800 hPa to 1060 hPa
- Shock (without packing): 10 g, duration 6 ms
- Environmental Conditions (Storage):
- Temperature: -10°C to 55°C
- Humidity: 10% to 95%
- Atmospheric pressure: 700 hPa to 1060 hPa
- Transport Conditions:
- Temperature: -40°C to 70°C
- Humidity: 10% to 95%
- Atmospheric pressure: 500 hPa to 1060 hPa
- Vibration, sinusoidal: 10 Hz to 500 Hz: 0.5g
- Shock: 30 g, duration 6 ms
- Bump: 10 g, duration 6 ms
API II LED:
- Voltage: 6V DC
- Light output: Minimum 1500 LUX (measured at 440mm from front window)
- Optical radiation: Complies with BS EN ISO 15004-1
Battery Life and Charging:
- Slimline Lithium-Ion:
- Battery attached to Indirect: ~2 hours for full charge, ~1 hour operating time on full power.
- Spare Battery: ~2 hours for full charge.
- Standard Lithium-Ion:
- Battery attached to Indirect: ~2 hours for full charge, ~2 hours operating time on full power.
- Spare Battery: ~4 hours for full charge.
- Normal battery life: 1.5 to 5 hours depending on setting.
- Recharge time: 2 hours for continuous trickle charging.
Electromagnetic Compatibility (EMC):
The device is a medical electrical instrument requiring special care concerning EMC. It is intended for use in all establishments, including domestic environments. Portable or mobile RF communication units may affect its operation.
- Emissions:
- RF emissions (CISPR 11): Group 1, Class B
- Harmonic emissions (IEC 61000-3-2): Class A
- Voltage fluctuations/flicker emissions (IEC 61000-3-3): Complies
- Indirect Ophthalmoscope RF emissions (CISPR 14-1): Complies
- Immunity:
- Electrostatic discharge (ESD) (IEC 61000-4-2): ± 8 kV contact, ± 15 kV air
- Electrical fast transient/burst (IEC 61000-4-4): ± 2 kV for power supply lines, ± 1 kV for power supply lines
- Surge (IEC 61000-4-5): ± 1 kV line(s) to line(s), ± 2 kV line(s) for input/output line(s)
- Voltage dips, short interruptions and voltage variations on power supply input lines (IEC 61000-4-11): Uₜ = 0% 0.5 cycle (0, 45, 90, 135, 180, 225, 270, 315°), Uₜ = 0%; 1 cycle, Uₜ = 70%; 25/30 cycles (@ 0°), Uₜ = 0%; 250/300 cycle
- Power frequency (50/60 Hz) magnetic field (IEC 61000-4-8): 30 A/m
- Conducted RF (IEC 61000-4-6): 6 Vrms, 150 kHz to 80 MHz
- Radiated RF (IEC 61000-4-3): 10 V/m, 80MHz to 2.7GHz
Usage Features
Headband Adjustment:
- Headband Size Adjuster (A) and Height Adjuster (B): For comfortable fit.
- Brow Bar (I) and Brow Bar Adjusters (F): Positions the binocular block (H) on the optical axis.
- Optics Hinge Adjuster (L): Allows positioning the All Pupil II as close to the eyes as possible for maximum field of view.
- Interpupillary Distance Setting Control (J): Located directly under each eyepiece, it adjusts the optics to ensure proper alignment for each eye, centering the object in the field of view while keeping it in the light patch. This should be done with the Aperture Control Lever (D) set to the large light patch.
Illumination and Viewing:
- Mirror Angle Control (K): Rotates the spindle on either side of the Binocular Block to position the light vertically into the upper two-thirds of the field of view.
- Headband Dimmer Switch (E): Rotated clockwise to turn on illumination.
- Aperture Control Lever (D): Changes aperture size for viewing through large, medium, and small pupils.
- Large: Round, homogenous patch suitable for routine examinations through fully dilated pupils.
- Intermediate: Reduces reflections when entering a partially or poorly dilated pupil (3mm), ideal for closer inspection of particular fundal areas.
- Small: Ideal for small, undilated pupils.
- Plano Lenses: Supplied with +2D lenses as standard; plano lenses are also available.
Charging and Power:
- Wireless Chargers: Available in Standard Lithium-Ion and Slimline Lithium-Ion versions.
- Charging Station:
- No indicator: Battery is fully charged.
- Flashing indicator: Top up charge.
- Solid indicator: Rapid charge.
- Headband Battery Holder: Flashing LED indicates battery requires charging.
- Wall Mounting: Wireless chargers can be wall-mounted using provided templates and hardware.
Teaching Mirror (Optional Accessory):
- Can be fitted to the instrument for teaching purposes. It slides onto a pin on the mounting bar and can be swivelled up and down. It can be made non-removable for security.
Maintenance Features
Cleaning and Disinfection:
- Non-immersion cleaning: Only manual non-immersion cleaning is permitted. Do not autoclave or immerse in cleaning fluids.
- Procedure:
- Disconnect power supply.
- Wipe external surfaces with a clean, absorbent, non-shedding cloth dampened with de-ionised water/detergent solution (2% detergent by volume) or water/isopropyl alcohol solution (70% IPA by volume). Avoid optical surfaces.
- Ensure no excess solution enters the instrument.
- Hand-dry surfaces with a clean, non-shedding cloth.
- Safely dispose of used cleaning materials.
- Reusable Depressor:
- Manually clean all surfaces with a suitable brush and de-ionised water/detergent solution (2% detergent by volume) at no more than 35°C.
- Examine for visible contamination.
- Safely dispose of used cleaning materials.
- Sterilize using a validated steam sterilizer complying with BS 3970 or equivalent standard: 134-138°C sterilizing temperature at 2.25 bar operating pressure for a minimum of 3 minutes hold time.
- Inspect the device after cleaning/sterilization to ensure all soil is removed and it operates as intended. Do not use if damaged.
Bulb / LED Replacement:
- Caution: Bulbs/LEDs can reach high temperatures; allow to cool before handling.
- Procedure:
- Disconnect the instrument from the electrical supply.
- Remove the bulb/LED from the back of the instrument.
- Insert the replacement, ensuring the key is aligned with the aperture and securely pushed in.
- All Pupil II bulbs can be replaced with an LED light source.
Battery Care:
- Use only Keeler approved batteries, chargers, and power supplies.
- Turn indirect off and attach new pack when replacing lithium battery.
- Remove batteries if the device will not be used for prolonged periods.
- Do not charge battery in environments outside 0°C to 40°C.
- Ensure correct battery orientation.
- Do not disassemble, modify, dispose of in fire, puncture, or short circuit damaged batteries.
- Handle damaged/leaking batteries with care; wash exposed areas with soap and water, seek medical attention if electrolyte contacts eyes.
General Safety and Warnings:
- Never use if visibly damaged.
- Do not use in the presence of flammable gases/liquids or oxygen-rich environments.
- Do not immerse in fluid.
- No modification to equipment is allowed.
- Mains plug is the means of isolation; ensure it is always accessible.
- Do not fit mains power adapter into a damaged outlet.
- Route power cords safely.
- Disconnect power lead before cleaning.
- Do not exceed maximum recommended exposure time.
- After bulb/LED removal, do not touch bulb/LED contacts and the patient simultaneously.
- Lithium-Ion batteries contain no toxic heavy metals.
- Dispose of product at end of life according to local environmental guidelines (WEEE).
Warranty:
- 3-year guarantee for the Keeler All Pupil II product (replacement or free repair) for faults due to faulty manufacture, provided the instrument and accessories have been used in compliance with instructions and proof of purchase is available.
- API II LED is guaranteed for 5 years.
- Batteries are covered by a 1-year warranty.
- Warranty is void if the instrument is tampered with, or if routine maintenance is omitted or not performed according to manufacturer's instructions.
- No user-serviceable parts inside; servicing/repairs must be carried out by Keeler Ltd. or authorized distributors.
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