JENIS PRODUK : PULSE OXIMETER NEONATUS

NAMA PRODUK : BIONET

MODEL/TIPE PRODUK : Oxy 9 Wave Neonatus
NO REG & MASA BERLAKU : KEMENKES RI AKL 20502113495, 1 Maret 2018
NAMA SOLE AGENT : PT. JAYAMAS MEDICA INDUSTRI
ALAMAT SOLE AGENT : Jl. By Pass KM. 28, Sidomojo, Krian, Sidoarjo - Jawa Timur
PHONE/ FAX. / E-MAIL : 031 8982349 / 031 8985268 / uus@onemed.co.id
NAMA PABRIK : BIONET CO., LTD., KOREA
ALAMAT PABRIK : 1101, E-C Dream Tower III, 197-33, Guro Dong, Guro-Gu,
Seoul, Korea

NAME OF PRODUCT Pulse Oximeter Neonatus

BRAND / MANUFACTURER BIONET
MODEL / TYPE Oxy 9 Wave Neonatus
COUNTRY OF ORIGIN Seoul, Korea
FACTORY OF ORIGIN BIONET Co.,Ltd
OUTSOURCE EXTERNAL MANUFACTURE (OEM) -
PRODUCT'S REGISTRATION (AKL/AKD) KEMENKES RI AKL 20502113495
PRODUCT'S CERTIFICATION
FDA Clearance Korean FDA
CE Mark (MDD) Yes
Certificate
ISO 13485 .... Yes
Certificate ....
WHERE MARKETED Indonesia
REFERENCE OF TECHNICAL
STAND-ALONE/ MODULAR Stand Alone
MOUNTING OPTIONS Yes
DISPLAYS
Type 3.5" Color TFT LCD
Pixel 320 x 480
Displayed data SpO2, BPM, SpO2 limits, Level bar, Pulse rate wave, Time &
Date, Alarm volume, battery status, Brightness
LED Display Sensor separation, Alarm silence, Charging status, Power
connection
SpO2 RANGE, % 40 % to 100%
Accuracy, % 70% - 100% + 2%, 0 - 69% : Unspecified
PULSE RATE, bpm 30 to 250 bpm
Accuracy 2bpm
MAJOR COMPONENTS
Main unit 1pc
SpO2 sensor 1pc
Power cable 1pc
Adaptor 1pc
Pole clamp 1pc
Manual user 1pc
DATA MANAGEMENT
Data stored Trend display 30 days at 10 second interval
PRINTER/RECORDER No
MRI CONDITIONAL No
POWER SUPPLY
Power consumption 24VA ( max )
During charging (power is off) 18VA
Adapter
Input 100 - 240V; 50 - 60Hz; 0.4A
Output +5V
Battery
Type Li-Ion battery 3.6Volts
Operating times Up to 15 Hours
Charging times 6.5 Hours
Low-battery notice Yes
Operating temperature 5 - 40 C
Non operating temperature -20 - 70 C
Humidity 5 - 95%
Operating altitude -1,000 - 12,000 ft
Dimension (H x W x D), cm (in) 4,5(H) x 21(W) x 7,5(D) cm
WEIGHT, g (oz) 300 g
PURCHASE INFORMATION
List price see attachment
Replacement probe Yes
Warranty 1 Year
Delivery time, ARO max 1 month
Year first sold 2008
Fiscal year
GREEN FEATURES
OTHER SPECIFICATIONS
UMDNS CODE(S)
LAST UPDATED
Supplier Footnotes
Model Footnotes
Data Footnotes
OTHER INFORMATIONS