Salient Characteristics - Pupilometers.pdf
PDF 130 KB Posted
- Attached to
- Pupilometers
- Solicitation number
- 0012384955
- Issued by
-
Department of the Army Medical Command
About this file
This document outlines the salient characteristics and technical specifications for pupilometers required under a federal contract opportunity. The pupilometers must meet minimum clinical performance requirements including accurate pupil size measurements within ±0.2mm tolerance, reaction time to light within 0.5 seconds, and consistent reproducibility of data across multiple readings. The devices must provide real-time results with rapid feedback, function effectively in low-light conditions, and demonstrate resistance to common measurement errors such as motion, ambient lighting, and patient eye movement. Additionally, the pupilometers must deliver clear, clinically interpretable outputs with user-friendly interfaces that facilitate accurate data entry and can withstand the physical rigors of clinical environments through shock resistance and ease of disinfection.
The devices must be powered by rechargeable lithium-ion batteries providing 4-6 hours of operation per full charge, with included charging cradles or adapters. An optional AC adapter accepting standard 100-240V AC power input is acceptable for stationary settings, and automatic power-off functionality is required to conserve battery life. No special biomedical technical training is required for equipment operation, though technical support must be available for persistent troubleshooting issues. The pupilometers must hold 510K Exempt Class 1 medical device designation from the USDA (K895609), comply with Part 15 of the Federal Communications Commission Rules, and meet electromechanical compatibility limits established in EN60601-1-2 for Medical Products.
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Salient Characteristics - Pupilometers
Minimum Clinical Performance Requirements:
- Accurate and precise measurements of pupil size, typically within a +-0.2mm tolerance
- Pupil to reaction time to light expected response time to be within 0.5 seconds
- Must be able to consistently measure pupil size and response over multiple readings, ensuring reproducibility of data
- Reaction time for pupillary constriction and dilation must be quick and responsive, providing results in real-time with a rapid feedback loop
- The illumination intensity must be sufficient to provoke a measurable response in a broad range of patient types, including those with diminished or impaired pupillary reflexes
- Provide accurate reading even in low-light conditions
- Must be resistant to common sources of measurement error or artifact, such as motion, ambient lighting conditions, and patient eye movement
- Provide clear and consistent outputs in a format that is easy for clinicians to interpret
- User interface should facilitate accurate and error free data entry
- Should be able to withstand the rigors of clinical environments, including being shock-resistant and easy to disinfect
- Should function properly over extended periods, maintaining performance without degradation
Source Considerations
Power source: The device uses rechargeable lithium-ion batteries. On a full charge, the device can operate for 4-6 hours depending on usage patterns. Comes with charging cradle or adapter that allows users to recharge the lithium-ion battery.
Voltage requirements: In addition to battery operation, the pupilometers may have an AC adapter option for use in a stationary setting where you do not need portability
- accepts a standard100-240V AC power input
- automatic power-off functionality to conserve battery when not in active use
Biomedical Tech Considerations
- Equipment requested will not require any special biomedical tech training
- Technical support offered if troubleshooting techniques do not work, and continue to persist
Certifications
- 510K Exempt Class 1 medical device by the USDA: K895609
- Complies with part 15 of the federal Communications Commission Rules
- Electromechanical Compatibility Notice: Equipment must comply with the limits set forth in EN60601-l-2 for Medical Products
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