Colposcope,portable,incl stand & access

GENERAL DESCRIPTION
Colposcope, hand-held, portable model including monopod, battery, charger and case.

INTENDED USE
The colposcope is used to triaging, diagnose, and manage precancerous cervical lesions in women by trained medical professionals. This model is portable and light weight, allowing it to be transported in a case or backpack.

TECHNICAL SPECIFICATIONS
The device is portable and light-weight making portability a key aspect of this device.
The device includes a pouch for storage purposes and to protect the device during transport.
Full spectrum visible light (white light) LED light source, delivering 30,000 Lux at 300mm (equivalent to 100-150 Watt quartz halogen bulb.)
Color Rendering Index > 93%.
LED lifespan > 40.000 hours.
Optical magnification of 5x, 8x, and 12x while digital zoom allows further magnification.
Adjustable illumination and be capable of focus, zoom and field of view adjustment.
Equipped with green light filters.
The unit comes with including a mobile phone with a screen resolution of 1920 x 1080 to function as a external screen and a connection cable.
Through the mobile phone any images can be displayed on an external screen with the use of a HDMI cable.
Images can be displayed on mobile devices or transmitted an external screen with a resolution of 1920 x 1080 pixels.
The device is able to capture and store images through connection to an external device (mobile phone/laptop).
Using a mobile device the colposcope can forward images to a LED TV or medical grade monitor using a HDMI connection and, if a printer is connected, allows printing of any captured images.
Unit comes with a charger to charge the internal lithium-ion battery which provides power for 2-4 hours operation.
Power requirements: 90 – 264 Volt, 47 – 63 Hz, 0.18A @ 120 VAC; 0.36A @ 240VAC.

SUPPLIED WITH
1 x Battery, lithium-ion
1 x Charger 90-264 Volt
1 x Case for colposcope and accessories
1 x Universal phone holder
1 x Clinical monopod (stand)

WARRANTY
Three years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 40°C / <80 % RH
- Storage conditions: -10°C - 70°C / <80 % RH

WEIGHT AND VOLUME
Weight: 9 kg
Volume: 55 dm3

LABELLING
In accordance with UNICEF technical requirements as indicated here:
https://www.unicef.org/supply/technical-specifications-packing-packaging -and-labelling

Products with market clearance from the USA FDA follow labelling requirements as stipulated in CFR code of regulations Title 21, part 801 - Labelling. Follow below hyperlink for details on this regulation.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801

ESTIMATED DELIVERY LEAD TIME
4 Weeks

INSTALLATION REQUIREMENTS
There is no need for a qualified technician for assembly or commissioning this device.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
As per user manuals.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

REGULATION & CONFORMITY REQUIREMENTS
- IEC 60601-1:2005 + CORR:1 (2005) + CORR:2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- ISO 14971:2019 Medical devices — Application of risk management to medical devices

CLASSIFICATION
USA FDA 510k (registration number: K132423) as Device Class 2.

NOMENCLATURE
- GMDN code: 10960