2. Spesifikasi Pulse Oxymeter
2
JENIS PRODUK : PULSE OXIMETER NEONATUS NAMA PRODUK : BIONET MODEL/TIPE PRODUK : Oxy 9 Wave Neonatus NO REG & MASA BERLAKU : KEMENKES RI AKL 20502113495, 1 November 2014 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 / [email protected] NAMA PABRIK : BIONET CO., LTD., KOREA ALAMAT PABRIK : 1101, E-C Dream Tower III, 197-33, Guro Dong, Guro-Gu, Seoul, Korea Pulse Oximeter Neonatus BIONET Oxy 9 Wave Neonatus Seoul, Korea BIONET Co.,Ltd - KEMENKES RI AKL 20502113495 Korean FDA Yes Certificat ISO 13485 Yes Certificate .... Indonesia Stand Alone Yes 3.2" Color TFT LCD 40 % to 100% 70% - 100% + 2%, 0 - 69% : Unspecified 30 to 250 bpm ± 2bpm ± 5 sec ± 10 sec ± 10 sec Yes Yes Silence for audible alarm Yes No Neonate spo2 sensor Neonate wrap spo2 sensor Neonate 1m spo2 sensor, 2m extention cable SELF-TEST MODE PROBE TYPES Disposable Reusable Patient range Cable length, m (ft) ALARMS Audible and visual Visual only ALARM OVERRIDE Reactivation method Volume control PULSE RATE, bpm Accuracy PERFUSION INDEX AND/OR SIGNAL STRENGTH INDICATOR RESPONSE TIME, sec START-UP TIME, sec or pulses AVERAGING TIME, sec STAND-ALONE/ MODULAR MOUNTING OPTIONS DISPLAYS Type SpO2 RANGE, % Accuracy, % PRODUCT'S REGISTRATION (AKL/AKD) PRODUCT'S CERTIFICATION FDA Clearance CE Mark (MDD) WHERE MARKETED REFERENCE OF TECHNICAL NAME OF PRODUCT BRAND / MANUFACTURER MODEL / TYPE COUNTRY OF ORIGIN FACTORY OF ORIGIN OUTSOURCE EXTERNAL MANUFACTURE (OEM
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Transcript of 2. Spesifikasi Pulse Oxymeter
JENIS PRODUK : PULSE OXIMETER NEONATUS
NAMA PRODUK : BIONET
MODEL/TIPE PRODUK : Oxy 9 Wave Neonatus
NO REG & MASA BERLAKU : KEMENKES RI AKL 20502113495, 1 November 2014
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 / [email protected]
NAMA PABRIK : BIONET CO., LTD., KOREA
ALAMAT PABRIK : 1101, E-C Dream Tower III, 197-33, Guro Dong, Guro-Gu,
Seoul, Korea
Pulse Oximeter Neonatus
BIONET
Oxy 9 Wave Neonatus
Seoul, Korea
BIONET Co.,Ltd
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KEMENKES RI AKL 20502113495
Korean FDA
Yes
Certificate ....ISO 13485 Yes
Certificate ....
Indonesia
Stand Alone
Yes
3.2" Color TFT LCD
40 % to 100%
70% - 100% + 2%, 0 - 69% : Unspecified
30 to 250 bpm
± 2bpm
± 5 sec
± 10 sec
± 10 sec
Yes
Yes
Silence for audible alarm
Yes
No
Neonate spo2 sensor
Neonate wrap spo2 sensor
Neonate
1m spo2 sensor, 2m extention cable
SELF-TEST MODE
PROBE TYPES
Disposable
Reusable
Patient range
Cable length, m (ft)
ALARMS
Audible and visual
Visual only
ALARM OVERRIDE
Reactivation method
Volume control
PULSE RATE, bpm
Accuracy
PERFUSION INDEX AND/OR SIGNAL STRENGTH
INDICATORRESPONSE TIME, sec
START-UP TIME, sec or pulses
AVERAGING TIME, sec
STAND-ALONE/ MODULAR
MOUNTING OPTIONS
DISPLAYS
Type
SpO2 RANGE, %
Accuracy, %
PRODUCT'S REGISTRATION (AKL/AKD)
PRODUCT'S CERTIFICATION
FDA Clearance
CE Mark (MDD)
WHERE MARKETED
REFERENCE OF TECHNICAL
NAME OF PRODUCT
BRAND / MANUFACTURER
MODEL / TYPE
COUNTRY OF ORIGIN
FACTORY OF ORIGIN
OUTSOURCE EXTERNAL MANUFACTURE (OEM)
Trend display 30 days at 10 second interval
No
No
AC Adaptor 220 Volt
Up to 20 Hours
6.5 Hours
Yes
4,5(H) x 21(W) x 7,5(D) cm
300 g
see attachment
Yes
1 Year
max 1 month
2008
LAST UPDATED
Supplier Footnotes
Model Footnotes
Data Footnotes
OTHER INFORMATIONS
Delivery time, ARO
Year first sold
Fiscal year
GREEN FEATURES
OTHER SPECIFICATIONS
UMDNS CODE(S)
Dimension (H x W x D), cm (in)
WEIGHT, g (oz)
PURCHASE INFORMATION
List price
Replacement probe
Warranty
LINE POWER, VAC
BATTERY TYPE (NUMBER)
Life, hr
Rechargeable
Recharge time, hr
Low-battery notice
DATA MANAGEMENT
Data stored
Data storage, hr
External output
PRINTER/RECORDER
MRI CONDITIONAL
