Note: Hospital use typically includes such as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital-type facilities include ambulance, physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub-acute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the monitor/ultrasound imaging system.

Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the vital signs monitor.

Intended Use for the M32

The M32 is intended to be used to monitor electrocardiography (ECG) - heart rate (HR) and pulse rate (PR), functional arterial oxygen saturation (SpO2), noninvasive blood pressure (NIBP) – systolic (SYS), diastolic (DIA) and mean arterial pressures (MAP), temperature (Temp), Invasive blood pressure (IBP) – systolic (SYS), diastolic (DIA) and mean arterial pressures (MAP), capnography – end-tidal carbon dioxide (EtCO2), fractional concentration of inspired carbon dioxide (FiCO2) and integrated pulmonary index (IPI) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. And this device is not intended for home and military use. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M32 is suitable for continuous operation.
The M32 Patient monitor is intended to connect the network or PC and output data or connect to MEDIANA Central Monitoring System using wired LAN, wireless LAN, Wi-Fi, Mobile or USB communication.
The CO2 module is intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, transport, intra-hospital transport and home environments.
The CO2 module provides the clinician with an integrated pulmonary index (IPI). The IPI is based on parameters provided by the CO2 sensor (end tidal carbon dioxide, and respiration rate) as well as parameters provided by the host monitor (oxygen saturation and heart rate). The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Intra-hospital transport includes transport of a patient within the hospital or hospital type facility. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and subacute care centers.
Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

Intended Use for the FM20

The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7”) Display, recorded on a strip chart recorder. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound.
Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during antepartum periods on pregnant woman.