Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Products

Mediana
  • Registration Date 2016-03-31
  • Hit 1994

[Company Information]

Name : Mediana

Company CI : attachment 1

Website Address (URL) : www.mediana.co.kr

Location

Head Office, Factory, R&D : 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea

Seoul Office : Mediana B/D 53, Donggwang-ro, Seocho-gu, Seoul, Korea

Mediana USA : Building 7/A, 2799 152nd Ave NE, Redmond, WA 98052. USA

Contacts : www.mediana.co.kr

Seoul Office : Tel 82-2-542-3375, Fax 82-2-542-7447

Head Office, Factory, R&D: Tel 82-33-742-5400, Fax 82-33-742-5418

[Product Information]

Monitor/Defibrillator

Product 1

Model : D500

Intended Use : The D500 defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or medical specialist in outdoor and indoor emergency care settings including air and ground ambulances within the environmental conditions specified. Manual and Automated external defibrillation, External pacing, Diagnostic electrocardiography (12-lead ECG) are intended for use on adult and pediatric patients. The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration (RESP), temperature (TEMP) and invasive blood pressure (IBP)) are intended for use on adult, pediatric and neonatal patients. End tidal CO2 (EtCO2)) are intended for use on adult, pediatric and infant patients.

Image : attachment 2

Product 2

Model : Orange1

Intended Use : The Orange1 defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or medical specialist in outdoor and indoor emergency care settings including air and ground ambulances within the environmental conditions specified. The Orange1 defibrillator/monitor is intended to be used during ground transportation except when specified otherwise. Manual and Automated external defibrillation, External pacing and the other monitoring functions (functional arterial oxygen saturation (SpO2), respiration (RESP), temperature (TEMP), invasive blood pressure (IBP) and end tidal CO2 (EtCO2)) are intended for use on adult and pediatric patients. Non-invasive blood pressure is intended for use on adult, pediatric and neonatal patients.

Image : attachment 2

AED - Automated External Defibrillator

Product 3

Model : HeartOnA10

Intended Use : The HeartOnA10 is intended to be used to treat someone who is unresponsive, non-breathing and pulseless for the adult and pediatric in all area of a hospital, pre-hospital, public access, alternate care and home healthcare environment. HeartOnA10 is designed to easy to use.

Image : attachment 2

Product 4

Model : HeartOnA15

Intended Use : The HeartOnA15 is intended to be used to treat someone who is unresponsive, non-breathing and pulseless for the adult and pediatric in all area of a hospital, pre-hospital, public access, alternate care and home healthcare environment. HeartOnA15 is designed to easy to use.

Image : attachment 2

Product 5

Model : HeartOnT10, T15 Trainer

Intended Use : The AED Trainer is intended to train for potential Automated External Defibrillator user and the Training Pads is intended to apply manikin and deliver a simulated shock from automated external defibrillator trainer.

Image : attachment 2

Patient Monitor

Product 6

Model : M50

Intended Use : The M50 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2), Multi gas, cardiac output (CO) and temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M50 is suitable for continuous operation.

Image : attachment 2

Product 7

Model : M20

Intended Use : The M20 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Image : attachment 2

Product 8

Model : M30

Intended Use : The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Image : attachment 2

Product 9

Model : YM6000

Intended Use : The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Image : attachment 2

Vital Sign Monitor

Product 10

Model : V10

Intended Use : The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulserate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

Image : attachment 2

Product 11

Model : YM1000

Intended Use : The purpose and function of YM1000 (N,NS, NST, NP, NSP, NTP, NSTP) vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult, pediatric and neonate patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics. YM1000S has no internal measurement and alarm function.

Image : attachment 2

ECG - Electrocardiograph

Product 12

Model : E30/40

Intended Use : The E30/40 is a resting ECG system, developed for adult patients; it records and analyzes ECGs, electrical heart activities, with acquired from patients body surface using electrodes. The device prints ECG report with thermal printer, send ECG data to PC, and preview ECG waveforms with LCD.

The E30/40 should be used by qualified user of organization. The diagnosis using ECG report should be performed hospital facilities by trained physician or clinician. Interpretation function should be used for one of helping method to review ECG report.

Image : attachment 2

CMS - Central Monitoring System

Product 13

Model : InfoWareD

Intended Use : The intended use of the InfoWareD Central Monitoring System is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printings, and provide the annunciation of alarms from other networked Defibrillator/Monitors at a centralized location. The InfoWareD Central Monitoring System provides for the retrospective review of alarms, physiologic waves and parameters from its database. The InfoWareD Central Monitoring System is used in all areas of a hospital and hospital-type facilities and it is not intended to use at home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Product 14

Model : InfoWareG

Intended Use : The intended use of the InfoWareG Central Monitoring System is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printings, and provide the annunciation of alarms from other networked Patient Monitors at a centralized location. The InfoWareG Central Monitoring System provides for the retrospective review of alarms, physiologic waves and parameters from its database. The InfoWareG Central Monitoring System is used in all areas of a hospital and hospital-type facilities and it is not intended to use at home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Product 15

Model : InfoWareM

Intended Use : The intended use of the InfoWareM Central Monitoring System is to display physiologic waves, parameters, trends, events and alarm messages transmitted from other Central Monitoring Systems which are networked with Defibrillator/Monitors or Patient Monitors at a centralized mobile terminal. The InfoWareM Central Monitoring System provides for the retrospective review of alarm messages, physiologic waves and parameters from its database. The InfoWareM Central Monitoring System is used in all areas of a hospital and hospital-type facilities and it is not intended to use at home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Attached File Attach all down
  • Attachment 1_Mediana Company CI.pdf Download
  • Attachment 2_Mediana total product.pdf Download

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