BESDATA 192875 Video Otoscope Instruction Manual
- July 27, 2024
- BESDATA
Table of Contents
BESDATA 192875 Video Otoscope
Product Information
Specifications
- Manufacturer: SHENZHEN BESDATA TECHNOLOGY CO., LTD
- Compliance: 93/42/EEC Medical Device Directive
- Power Source: One 18650 battery
- Battery Life: Approximately 2 hours
Product Usage Instructions
Introduction
Product Overview
The BESDATA Video Otoscope is a hand-held medical device equipped with a video
camera for capturing images of the outer ear canal and tympanic membrane. The
device features preset focus, brightness, and white balance settings, with a
built-in screen for direct image display.
Intended Use
The BESDATA Video Otoscope is designed as an assistive tool for observing ear
health conditions. Its applications include inspection of the outer ear canal,
and tympanic membrane, and detection of hearing aid devices. Additionally, it
can be used with a flexible camera module to monitor nasal and mouth cavity
health conditions.
Operations
Setting up the Video Otoscope
- Align the mounting base and insert the otoscope camera module.
- Turn clockwise to tighten (avoid overtightening).
- Push the otoscope protective cover onto the camera module until it locks. After use, remove and discard the cover.
Operating Instructions
- Power ON/OFF: Press and hold the power button for 2 seconds to switch on/off the device.
- Battery Conditions: When charging, the light indicator changes from green to yellow and back to green when fully charged.
- Image Freeze/Video: Use the designated button to freeze or enter video mode.
FAQ
-
Q: Can the BESDATA Video Otoscope be used without professional supervision?
A: It is recommended to operate the otoscope under the supervision of a trained ENT doctor or health professional familiar with otoscopy. -
Q: What precautions should be taken while using the device?
A: Avoid using the device near inflammable anesthetics and ensure proper disposal or recycling of the components following local regulations.
Thank you for choosing the BESDATA® Video Otoscope, the Video Otoscope choice for health care professionals. The operating and maintenance instructions found in this manual should be followed to ensure product reliability. Please read this manual carefully before using the product. If you encounter a technical problem related to the operation of the BESDATA® Video Otoscope, please contact your local dealer for after-sales support.
The manufacturer declares on his/her sole responsibility that the product conforms with the essential requirements of the 93/42/EEC Medical Device Directive, and that the relevant conformity assessment procedures
Copyright belongs to SHENZHEN BESDATA TECHNOLOGY CO., LTD. Reproduction or reprinting of any part of this manual by any means without written authorization from SHENZHEN BESDATA TECHNOLOGY CO., LTD. is strictly prohibited. Printed in China.
Introduction
Product Overview
- The BESDATA Video Otoscope is a hand-held medical device that includes a video camera for capturing a video image of the outer ear canal and/or tympanic membrane. The image is displayed directly on a built-in screen.
- The BESDATA video otoscope is preset for its focus, brightness level, and white balance. It is powered by one 18650 battery for a continuous operation of about 2 hours.
Intended use
- The BESDATA video otoscope is as an assistive tool to observe the health condition of the ear. Indications for use include Inspection of the outer ear canal and tympanic membrane and detection of hearing aid devices.
- The device may also be coupled with a flexible camera module to monitor the health condition of the nasal cavity and mouth cavity.
Indications for use include:
- nasal cavity: asal vestibule, nasal septum, inferior turbinate and inferior nasal meatus, middle turbinate, and middle nasal meatus.
- Mouth cavity: inspection of palate, tongue, and anterior of the oropharynx.
Product Drawing
Cautions and warning
CAUTIONS:
The BESDATA video otoscope should be operated under the supervision of a
trained ENT doctor or health professional with sufficient knowledge of
otoscopy.
Do not use this device in the presence of inflammable anesthetics.
- Please follow local rules and regulations regarding the disposal or recycling of the device and its components.
- The Video signal output (RCA Port) connector is intended for connection to devices that comply with IEC 60601-1, or other IEC standards (for example, IEC 60950), as appropriate to the device.
- Do not use alcohol, chemicals, or water to clean the lenses. Solution entering the optical assembly can cause short circuits for electrical components.
- A portable and mobile wireless communications device that transmits radio frequency (RF) may affect the performance of the medical electrical device.
- Please remove the batteries if the device is stored for a long time.
- Some patients may feel warm and uncomfortable at the probe during the diagnosis when the device is left switched ON for a long period. The operator of the device should first discuss the possible discomfort with the patient, and when necessary withdraw the device from the patient and switch it off until the probe no longer feels warm.
WARNING:
- No modification of this equipment is allowed.
- Under an extreme laboratory test condition at 40°C, the applied part of the device may be measured at a temperature of no higher than 60°C and its enclosure at 49°C if it is turned on continuously for more than 2 hours.
Operations
Setting up the Video Otoscope
- Align the mounting base and insert the otoscope camera module.
- Turn clockwise and tighten. (Do not over-tighten)
- ①. Push the otoscope protective cover onto the otoscope camera module until it clicks into a lock position.
②. After use, remove the otoscope protective cover of the otoscope camera module and discard it.
Operating instructions
-
Power ON/OFF
Press and hold the power button for 2 seconds to switch the device on. -
Battery Conditions
When the otoscope is charging, the light switches will change from green to yellow. When fully charged, the light switches will change from yellow to green. -
Image Freeze/video/Enter button
When the power is turned ON, Press the image freeze button for less than 1 second to freeze the image, and press the same button again for more than 3 seconds to record the video. This key can also be used as a menu confirmation function. -
Playback button
When the power is turned ON, Press the playback button to preview the frozen photos and videos. -
Menu button
Press the menu button to enter the menu directory list. There are four functions in the directory list: back camera mode, recording camera mode, playback, and setting. The setting includes four functions: date setting, time setting, language setting, and formatting SD card. -
Up button and down button
When entering the menu page or playback page, you can press the up button and down button to switch pages. -
Charge
Connect one end of the adapter to the socket and the other end to the USB type-C of the charging base. When the power of the otoscope is insufficient, the otoscope can be placed on the charging base for charging. -
Data transmission and charge
Connect one end of the video out cable to the USB type-C for the otoscope and the other end to the monitor video port for data transmission. This interface also has a charging function. Connect one end of the adapter to the socket and the other end to the USB type-C for the otoscope for charging.
Specifications
Item
|
Specifications
---|---
Model| VOT-01| VOT-02| VRN-01| VRN-02
Angle of view| 70°| 70°| 70°| 70°
Focal length/distance| 5-60mm| 5-60mm| 5-60mm| 5-60mm
Tip diameter| Φ4mm| Φ4.2mm| Φ4.2mm| Φ7mm
Working length| 30mm| 90mm| 175mm| 185mm
Weight| 306g| 310g| 316g| 336g
Resolving power| 1280*720
Item
|
Specifications
---|---
Model| VOT-01| VOT-02| VRN-01| VRN-02
Battery model| 2500mA| 2500mA| 2500mA| 2500mA
Charging time| ≤2hour| ≤2hour| ≤2hour| ≤2hour
Discharge time| ≥2 hour| ≥2 hour| ≥2 hour| ≥2 hour
SD card compatibility| 32G| 32G| 32G| 32G
Charging specification| 5V/1A,5V/2A| 5V/1A,5V/2A| 5V/1A,5V/2A| 5V/1A,5V/2A
Storage Conditions
|
Video Otoscope
---|---
Ambient Temperature| 10°C to 40°C
Relative Humidity| Minimum 10% RH, Maximum 85% RH, Non-
Condensing
Atmospheric Pressure| Minimum 70kPa, Maximum 106kPa
Transport Conditions
|
Video Otoscope
---|---
Ambient Temperature| -20°C to 50°C
Relative Humidity| Minimum 10% RH, Maximum 95% RH, including
Condensing
Atmospheric Pressure| Minimum 70kPa, Maximum 106kPa
Operating Conditions
|
Video Otoscope
---|---
Ambient Temperature| 10°C to 35°C
Relative Humidity| Minimum 10% RH, Maximum 85% RH, Non-
Condensing
Atmospheric Pressure| Minimum 70kPa, Maximum 106kPa
Cleaning and Storage
For cleaning of the camera probe
- 1st Step: Take out the alcoholized prep-pad.
- 2nd Step: Clean and wipe the Copper plating part of the standard/long camera module or the outer sheath of the flexible camera module with the alcoholized prep pad.
- 3rd Step: Gently clean the camera lens with the cotton swab. Be careful not to scratch the lens of the camera module. Be careful
For cleaning the main unit
- The housing of the main unit can be cleaned with a cloth dampened with water, alcohol, or a non-staining disinfectant.
- Liquids should not be dripped or spilled over the surfaces of the LCD module, pogo pins, or handle as they are not watertight.
Storage
- The camera module and main unit should be placed in the storage compartment of the carrying case.
- Unnecessary exposure to extremes in temperature and humidity should be avoided.
Troubleshooting
Why is the BESDATA video otoscope not switched ON?
- Please check whether the otoscope has power. If it has no power, please charge it;
- Please confirm whether it is an SD Memory Card problem. You can take out the SD Memory Card and reinsert it;
- Please confirm whether the switch button is damaged; Press the switch button to check whether the button reacts;
- If the device is NOT switched ON by repeating the above steps, please contact your local dealer for technical support.
After the device is switched ON, the power indicator light is ON but no image is displayed or the image is fuzzy and unstable.
- Confirm whether the LED light in front of the camera module is on.
- Confirm if the camera module is mounted properly.
- Confirm whether the camera module and the mounting base are tightened.
- Confirm if there is any foreign substance stuck on the metal contact and clean the surface of the metal contact with an alcoholized prep pad.
- If the image is still NOT displayed properly after carrying out steps 1-5 above, please contact your local dealer for technical support.
The device is switched ON with the image displayed but I can’t freeze the image.
- Restart the device and try the freeze function again.
- Check and confirm the button can be depressed with ease, and repeat at least 10 times.
- The main unit may be defective if the freeze function does not work after repeating the above steps for several times. Please contact your local dealer for technical support.
Parts
Basic Parts
Item
| Description| Quantity|
Description
---|---|---|---
1| Main device| 1| The device may be coupled with a flexible camera module
2| Camera module (30mm)| 1| Check the external auditory canal and tympanic
membrane, and check for hearing aids.
3| Charging base| 1| Charge the video otoscope.
4| Protective cover| 1| Protect Camera module
5| Adapter| 1| Connect the video out cable
6| video out cable| 1| Transfer data to the device
7| Cotton Swab| 2| Clean Camera module
8| Instruction| 1| video Otoscope operation manual
Optional Parts
Item
| Description| Quantity|
Description
---|---|---|---
9
| ****
Camera module (90mm)
| ****
1
| Check the nasal vestibule, nasal septum, inferior turbinate and inferior nasal meatus, middle
turbinate and middle nasal
meatus.
10
| ****
Camera module (175mm)
| ****
1
11| Camera module (185mm)| 1| Check the palate, tongue and
anterior oropharynx.
Parts List
Limited Warranty
Each of the BESDATA® video otoscope comes with a one-year warranty, starting on the purchase date to cover repair and/or if necessary replacement of any product failure due to defects in materials and workmanship. Within the limited range of the warranty, defective products shall be repaired or replaced by the Manufacturer or authorized technical and service groups at their options and to the extent permitted by law.
This warranty is non-transferable. Damages due to negligence, accident, abuse, misapplication, modification, or repairs not made by the Manufacturer, or authorized technical and service groups, are not covered by the warranty. Within the coverage of the warranty, the delivery fee for mailing to the local dealer or the direct store is not covered within the scope of the warranty.
Manufacturer:
SHENZHEN BESDATA TECHNOLOGY CO., LTD
BESDATA® is a registered trademark of SHENZHEN BESDATA TECHNOLOGY CO., LTD Assembled in the China.
Appendix
Table 1
Guidance and manufacturer’s declaration-electromagnetic emissions. The
BESDATA® video otoscope is intended for use in the electromagnetic environment
specified below. The customer or the users of the device should ensure that it
is used in such an environment.
Emissions test| Compliance| Electromagnetic environment –
guidance
---|---|---
RF emissions CISPR11| Group 1| The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions CISPR11| Class B| The device is suitable for use in all
establishments, including domestic establishments and those directly to the
public low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
| Not Applicable
Voltage fluctuations/flicker emissions IEC 61000-3-3| Not Applicable
Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity. The BESDATA®
video otoscope is intended for use in the electromagnetic environment
specified below. The customer or the user of the device should ensure that it
is such an environment.
Immunity test
| IEC 60601 test level| Compliance level|
Electromagnetic environment-guidance
---|---|---|---
Electrostatic discharge (ESD)
IEC
61000-4-2
| ± 6 kV contact
± 8 kV air
| ±6 kV contact
± 8 kV air
| Floors should be of wood, concrete, or ceramic tiles. If the floor is tiled
with synthetic material, the relative air humidity must be 30 % at least.
Electrical fast transient/bursts
IEC 61000-4-4
| ± 2 kV for power supply lines
± 1 kV for
input/output lines
| Not Applicable|
Surge| ±1 kV line(s) to| Not|
IEC 61000-4-5| line(s)| Applicable
| ±2 kV line(s) to|
| earth|
Voltage dips,| < 5 % UT (>95 %| Not|
short| dip in UT) for 0,5| Applicable
interruptions| cycle|
and voltage| 40 % UT (60% dip|
variations on| in UT) for 5 cycles|
power supply| 70 % UT (30% dip|
input lines| in UT) for 25 cycles|
IEC 61000-4-11| < 5 % UT (>95 %|
| dip in UT) for 5 s|
Power frequency magnetic field IEC 61000-4- 8| 3 A/m| 0,3 A/m|
If image distortion occurs, it may be necessary to position the device’s image intensifier further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to ensure that it is sufficiently low.
NOTE:
UT is the a.c. mains voltage before application of test level.
Table 3
Guidance and manufacturer’s declaration-electromagnetic immunity The BESDATA®
video otoscope is intended for use in the electromagnetic environment
specified below. The customer or the user of the device should ensure that it
is such an environment.
Immunity test| IEC 60601
test level
| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted RF IEC
61000-4-6
|
3 Vrms
150 kHz to80 MHz
|
Not Applicable
| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance d=1,2√P d =1,2√P 80MHz to 800 MHz d =2,3√P 800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m).
Field strength from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC
61000-4-3
|
3 V/m 80MHzto2,5 GHz
|
3 V/m
NOTE 1: At 80 Hz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptions and reflections from structures, objects, and people.
A Field strength from transmitters such as base stations for radio (celluar/cordes) telephones and mobile radio, amateur radio, AM and FM radio, and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
Over the frequency range of 150 kHz to 80 MHz, field strength should be less than 3 V/m.
Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the BESDATA® Video Otoscope The device is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled.
The user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and the device as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum|
Separation distance according to the frequency of transmitter m
---|---
the output power of the transmitter W|
150 kHz to 80 MHz
d=1,2√P
|
150 kHz to 80 MHz
d=1,2√P
|
150 kHz to 80 MHz
d=1,2√P
0,01
|
0,12
|
0,12
|
0,23
0,1
|
0,38
|
0,38
|
0,73
1
|
1,2
|
1,2
|
2,3
10
|
3,8
|
3,8
|
7,3
100
|
12
|
12
|
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in the meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.
NOTE 1: At 80 Hz and 800 MHz the separation distance for the frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorptions and reflections from structures, objects, and people.
References
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