FORMAT SPESIFIKASI

I DATA ADMINISTRASI (*
JENIS PRODUK : ARRHYTHMIA DETECTOR AND ALARM
NAMA PRODUK : MEK INTENSIVE CARE PATIENT MONITOR
MODEL/TIPE PRODUK : MP 1000NT PLUS
NO. REGISTRASI DAN MASA BERLAKU : KEMENKES RI AKL 20501310086/ 15 Mei 2024
NAMA SOLE AGENT : PT. Permana Putra Mandiri
ALAMAT SOLE AGENT : JL. Taman Mini Indonesia Indah (TMII)
Pintu II atas No.43 Cipayung
Jakarta Timur - Indonesia
PHONE/ FAX. / E-MAIL : ±62-21 841 5976/ ±62-21 840 7865/ info@ptppm.id
NAMA PABRIK : MEKICS CO., LTD., Korea
ALAMAT PABRIK : Industrial Zone 861-10 Taegye-dong, Chunchon-si, Kangwon-do
Korea 200-944

* seluruh data izin edar sesuai izin registrasi

Data administrasi diisi sesuai dengan data yang tercantum dalam
izin edar

II DATA SPESIFIKASI (*
(*untuk informasi spesifikasi lain yang dimiliki alkes semua
dimasukan kedalam informasi tambahan
INFORMASI PRODUK PRODUK

COUNTRY OF ORIGIN
FACTORY OF ORIGIN
OUTSOURCE EXTERNAL MANUFACTURE (OEM)
PRODUCT'S REGISTRATION (AKL/AKD)
PRODUCT'S CERTIFICATION
FDA Clearance
CE Mark (MDD)
Certificate ISO 13485
Certificate ....
(* informasi produk di isi sesuai dengan yang dimiliki oleh produk
tersebut

ECG
Channel 3 channels
Electrode 3 electrode
Lead (I, II, III)
Dynamic range 10mV
Heart rate 20 ~ 300bpm
Accuracy ±2%
Input signal range ±0.5mV ~ ±5mV
Defibrillator Protection Defibrillator Discharge : <5s
Defibrillation artifact Recovery Time <5s
Pacemaker Detection Mode User available
ST Level measurement User available (range: +0.99~0.99mV)
Arrhythmia analysis available
PVC Detection with display indicator available
Automatic Biasing and Scalling for ECG signal Display
Respiration
Method impedance for ECG LEAD II
Respiration rate -2~150bpm
Accuracy ±1bpm
Detect sensitivity 0.5 ohm min
Sensitivity 30~90%
SpO2
Range 0~100%
Accuracy Adult : ±2% for readings 70~100%
±3% for readings 50~69%
Neonate : ±3% for readings 70~100%
Unspecified 0~49%
NIBP
Measurement range 0~300mmHg
Auto deflation pressure Adult : 300mmHg
Neonate : 150mmHg
Measurement time : max 40sec
Automatic/STAT Mode
IBP (Optional)
Measurement range -50~300mmHg
Sensor 5uV/mmHg
Accuracy ±2%
Zero balance ±150mmHg
 Automatic Biasing and Scalling for IBP signal Display
Temperature (Optional)
Sensor YSI 400 series (Optional)
Resolution 0.1°C
Measurement range 0~50°C
Accuracy ±0.2°C(15~33°C, 42~45°C)
±0.1°C(34~41°C)
GENERAL
Display
Display 10.4" Color LVDS LED LCD
Resolution 800(H) x 600(V)
Trace line 7 wave form max
Vital sign graphic HR, SpO2, NIBP, IBP, Temp, Resp, Co2 trend
Display parameter
Traceline color and Parameter color changeable (40 color)
Heart rate and alarm limit
SpO2 percentage and alarm limit
Blood pressure (NIBP, IBP)
Respiration
Temperature
72hrs Graphic trend of Vital signs, Value & Time
Name, Bed ID, Date & Time and Menu information
Event management (Save up to 30 Event memory capacity)
Alarm
Alarm All parameters on/off slective independently
Alarm silence 2:00 Menit
Power Input 100~240 VAC, 50/60Hz
Operating time Battery 1Hr
Power consumption 150 Va (Max)
Dimensions W282 X H315 X D165
Weight 5Kg max. (with Printer)
Environmental
Operating Temperature 10~40C (50~104F)
Storage Temperature -20~70C (-4~158F)
Relative Humidity 10~90% (operating), 0~95% (storage)
EtCo2 (Optional)
Measurement range 0~99mmHg
Respiration range 0~150bpm
Accuracy ±2mmHg, 0~38mmHg
±5%, 39~99mmHg
Sampling rate 50ml/min
Initialization time 30 second (typical), reaches +/-5%
steady-state accuracy within 3 minute
Printer (Optional) 58mm thermal printer

INFORMASI SPESIFIKASI TAMBAHAN LAIN YANG ADA

(*Spesifikasi di isi sesuai dengan produk anda sendiri

Tidak semua kolom harus diisi, disesuaikan dengan spesifikasi
produknya

III INFORMASI LAINNYA

Garansi : Garansi Unit 1 Tahun
Training : ………………………………………………………..
Spare Part : ………………………………………………………..
Dan Lain-Lain : ………………………………………………………..

Catatan:
informasi lain diisi sesuai dengan produk anda sendiri
Tidak semua kolom harus diisi, disesuaikan dengan produknya