Name of Equipment (License Number) | U-Healthcare in vitro insulin injector (listed after approval)
|
Name of Model | DIA:CONN P8b(black), DIA:CONN P8w(white) |
Manufacturer | G2E Co., Ltd. #205 #206, 102 Dong, 36 Bucheon-ro, 198 beon-gil, Bucheon-si, Gyeonggi-do, Republic of Korea (Chunui Techno Park, Chunui) |
Product Number and Manufactured Date | Refer to the label on the back |
Size
33.2 x 162.6 x 19.4 mm
Weight and Unit to be Wrapped
65g (Except for cartridge), Unit 1
Cartridge
Tolerance
3ml (100U/ml)
Unit for Setting Injection
0.1U
Injection
Accuracy
Within 5%
Injection
Threshold
0.5~60.0U (Default) Up to 160U per day, up to 60U per time (for adults)
Maximum injection pressure and alarm threshold for blockage is 700 kPa
Injection
Accuracy
- As a result of self-testing with the insulin cartridge compatible with this device, it was confirmed that the injection accuracy was measured within 5% of the tolerance range.
- Average injection accuracy (number of test samples: 3EA)
Blockage
Detection
- Minimum injection rate: 60 seconds when the injection rate is set to "0.2U/sec"
- Medium injection rate: 12 seconds when the injection rate is set to "1U/sec"
Program for a Safety Check
The device stops injection when a single failure condition occurs, and no additional insulin is injected.
Injection Unit for Sec.
0.2U, 0.5U(default), 1U, 2U per second is settable
Power and Battery
3.7V, 170mAh, Lithium Polymer battery
Storage Capacity for
Injection Record
Approximately 1,000 individual doses
USB Rated Voltage
USB 5V, 200mAh
Used Wireless Frequency
2402 ~2480 MHz (BLE)
Max RF Output Power
LE_1M = 2.50 dBm(e.i.r.p)
LE_2M = 2.49 dBm(e.i.r.p)
Storage Environment
-25~5℃, 5~35℃(max 90% RH), 35~70℃(max 50hPa)
Atmospheric pressure: 700 ~ 1060hPa
User Environment
5 ~ 40℃, 15~90%RH, * Teste Temperature (-10 ~ 50℃)
Atmospheric pressure: 700 ~ 1060hPa
Display
OLED (White, Blue)
Time for
Battery Consumption
2 days (injection 12 times per day, by the standard of Bluetooth always on)
Battery Life
5 years (by the standard of 1000 times charge cycle ).
Used Motor
3V DC-Motor (N20 U-Type Geared Motor)
Protection Type for
Electric Shock
Internal power equipment
Criteria of Prevention for
Electric Shock
BF-type component is applied
Ranges for Waterproof
IP21 (IP22, if keeping the pouch)
*The first digit indicates the degree of dust protection, and the second digit indicates the degree waterproof protection.
IP21 is protected against the penetration of objects thicker than a finger and is protected against vertical drops of water, while IP22 is protected against penetration of objects thicker than a finger and against drops of water falling at an angle of 15° from the vertical.
Language
Korean, English, German
Certification Period
(Expected Life)
2 years (5 years from the date of the first use)