COLPOSCOPE, digital, EVA Pro

Complies
Wi-Fi IEEE 802.11
IEEE 802.15.4 Bluetooth class II
CISPR 11 Radiated RF Emission
IEC 60601 Test Level
IEC 6100-4-2 electrostatic discharge (ESD)
IEC 61000-4-3 Radiated RF
EC 61000-4-8 Rated Power-Frequency Magnetic Field

Not Applicable
IEC 6100-3-2 Harmonic Distortion
IEC 61000-3-3 Voltage Flicker
IEC 61000-4-4 Electrical fast transient/burst
IEC 61000-4-5 Surge
IEC 61000-4-6 Conducted Disturbances
IEC 6100-4-11 Voltage dips, short interruptions

Power

• Supply: 12 VDC
• Output: 49W
• Battery Pack: 3-cell 2.6AH Li-ion
• Battery Charger: 12.6VDC, 1.8amp output
• Charge Time: 2-3 hours
• LED LIght: White Cool 5700K

Equipment

• Dimensions WHD: 8x24x12 cm
• Weight: 435g
• Operating Temperature: 10-40C
• Relative Humidity: 0-80% non condensing
• Altitude: 2000m
• Transport and Store: 10-40C 0-80% rh
• IP Rating: IP21
• WiFi enabled: 2.4 GHz 50m max
• Bluetooth enabled: V4.2 20m max
• CISPR11: Group 1, Class A
• EMC: max 2W @ 0.3m ~28V/m all bands

UN 3480 & 3481
Lithium ion batteries packed with equipment
Can be shipped by air per DGR appropriate of IATA DGR

• PI 965 Section IB
• PI 966 Section II
• PI 967 Section II

● EVA Pro Digital Colposcope Device
● Two Removable Lithium-Ion Battery Packs
● Charging Base with A/C Adapter and universal plugs
● Hard Shell Carrying Case
● Stand Connector
● Instructions for Use

● Tripod / Wheeled Stand

WARNING AND PRECAUTIONS
1. No modification of this equipment is allowed.
2. Local and/or other applicable laws may restrict the sale of this device to, or to the order of, a physician or other proprietary licensed medical professional.
3. The device may emit electromagnetic radiation that may affect the performance of other electrically powered equipment, or the performance of the device may be affected by electromagnetic radiation from other electrically powered equipment in the vicinity.
4. Other equipment could interfere with the EVA Pro, even if other equipment complies with CISPR emissions requirements.
5. NOTE: This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
6. The LED light is extremely bright and should be the only illumination used as a light source during an examination. Do not stare directly into the light when it is in operation.
7. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the EVA Pro, including cables specified by the manufacturer.
8. Only connect the EVA Pro to secured, trusted Wi-Fi networks.
9. The EVA Pro batteries should only be connected to the Provided recharging base.
10. The EVA Pro device and accessories have not been tested for magnetic resonance imaging (MRI) safety. Avoid use near MRI equipment.
11. Prior to touching the camera lens or the LED lights, please consult the manual.
12. The EVA Pro should only be transported in its protective carrying case to avoid overbalancing.
13. Do not immerse any part of the colposcope in cleaning solutions or any fluid
14. Do not use strong detergents or alcohol under any circumstances for optics cleaning. This would lead to irrevocable damage to the optically-coated lens surfaces.
15. To limit contamination, use recommended disinfectant agents between each exam.
16. Do not use corrosive materials or strong cleaning materials other than those specifically prescribed on the casings or on the optics.
17. If the LED light ceases to work, due to battery drain or LED burn out, stop using the colposcope and recharge the batteries. Sometimes a discharged battery will manifest via a flickering LED. In this case, recharge the battery to full capacity before continuing use.
18. FCC CAUTION: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment.
19. Further RF exposure reduction can be achieved if the product is kept as far as possible from the user body or is set to a lower output power if such function is available. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
20. Per AAMI TIR69:2017, the risk associated with this device is assessed as Category D NEGLIGIBLE for wireless QoS needed for safe and effective operation.
21. WPA2 wireless AP recommended.
22. WiFi Connection Issues: If there are issues connecting to a WiFi network, ensure that you have the correct password and that you are entering it correctly. WiFi passwords are case sensitive. If problems still persist, restart the device, forget the WiFi connection, and try again. Ensure that other WiFi devices can connect to the WiFi successfully. Try connecting the device to another WiFi network. If problems still persist, user should contact customer service.
23. Patient Data Transmission Issues: If patient data transmission fails, please reboot the device and try again. Ensure that your WiFi connection to the Internet is functioning correctly. Ensure that no firewall or proxy settings on the WiFi network are limiting access to the internet.
24. The MobileODT EVA Pro device contains a 12V lithium-ion battery pack. Please observe the following practices:

• Do not place the device on or near fires, heaters, other high temperature locations, or apply heat directly to the unit or battery pack.
• Do not pierce the unit or battery pack with any sharp objects, strike the unit or battery pack with a hammer, tools, or heavy objects, step on the unit or battery pack, or otherwise damage the unit or battery pack.
• Do not subject the unit to strong impacts or shocks.
• Do not expose the unit or battery to water or any other types of liquid, or allow the battery to get wet.
• Do not leave the unit or battery in direct sunlight and avoid storing in vehicles in extreme hot weather. Doing so may cause the battery to generate heat, rupture, or ignite. Using the battery in this manner may result in a loss of performance and short battery life.
• Remove the battery if the device is not likely to be used for some time.

There are no serviceable parts. If any failure has developed, contact MobileODT to purchase a replacement part or system. The EVA Pro includes a USB-C interface that is for maintenance use only.

The EVA Pro handle, charging base, and power supply are reusable and should be routinely cleaned with a clean damp cloth or with an anti-microbial wipe. Any service to the EVA Pro must be performed by MobileODT.

WARNING: Do not submerge the EVA Pro handle, battery charger, or battery in fluid of any type. It may short the electronics and cause an electrical shock to the user.

If you or your organization purchased the Device directly from MobileODT then MobileODT warrants that the Device will be free from defects in material and workmanship when used normally in accordance with the then-current Terms and related documentation for a period of one (1) year from the date of delivery of Device

10-40C 0-80% RH non condensing

When the EVA Pro handle or battery are no longer functional or show signs of wear and damage, they should be disposed of in the same manner as electrical waste.

Description approved by OBGYN referent OCB (Séverine Caluwaerts) in January 2026.