A battery-powered, hand-held, device primarily designed for examining the outer ear canal and tympanic membrane by direct viewing through the ear opening during ENT treatments. Supplied including batteries.
Indicative Price 40.97 USD
Otoscope set for visual examination of the eardrum and the outer ear, Otoscope set composed of diagnostic head on a handle.
Viewing lens magnification 2.5-3x
Color temperature: Cool white in the range 3100-5500K
Light intensity: 8,000-12,000 lux
Cleanable with alcohol wipes
Handle with on/off switch.
Scratch-resistant lens; glass (preferred) or plastic
Port for an insufflation bulb
Set contained in a hard storage case.
Liquid splash resistant
Weight: < 0.170kg without batteries
Standard AA or AAA or rechargeable
Battery life: at least 3 hours of use on full charge or fresh batteries
Low battery or charge status indicator (as applicable to rechargeable type only)
Supplied without batteries (as applicable to AA/AAA type only)
Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.
Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%.
Clear instructions for use / diagrams for assembly in 3 languages (English, French, Spanish), list of accessories / parts.
1 X set of at least 8 reusable plastic specula of 4 (min) diameters ranging from 2-5mm.
Battery charger (as applicable to rechargeable type only)
Soft ball and tube for pneumatic tests
Sufficient light bulbs for 3 years use
Packaging, labelling instructions:
Packaging and Labelling:
Labelling on the primary packaging:
Name and/or trademark of the manufacturer.
Manufacturer's product reference; Type of product and main characteristics; If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging; Lot number prefixed by the word "LOT"(or equivalent harmonized symbol) (if applicable); Information for particular storage conditions(temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonized symbol); Information for handling, if applicable(or equivalent harmonized symbol).
Labelling on the packaging unit:
Labelling to be the same as primary packaging. Extra information required: Number of units.
Instructions for use should indicate:
“For examination of inner ear, canal and tympanic membrane. Batteries should be ordered separately. Specula must be thoroughly cleaned and disinfected after each use to prevent cross contamination.”
Instructions for use:
Examination of inner ear, canal and tympanic membrane.
Batteries should be ordered separately.
Specula must be thoroughly cleaned and disinfected after each use to prevent cross contamination.
Weight and Volume
Estimated weight: 7kg
Estimated volume: 22.800cdm
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