Transcutaneous Monitoring System
- UID
- IMP/MD/2022/000584_e22a2afba2f5e44cf5fcd61e6836d63d_fa2e24e4aa7592bc3baa4e57b43b30f0
- Device class
- Class B
- Brand name
- TCM5 Monitor
- License holder
- DHR Holding India Pvt. Ltd,
- Approving authority
- CDSCO
- Product information
- The TCM5 monitoring system including the TCM5 monitor, tc Sensors and accessories is intended for non-invasive continuous transcutaneous monitoring of: • carbon dioxide partial pressure (TCM5 Monitor), functional oxygen saturation (TCM5 Monitor) and pulse rate (TCM5 Monitor), using the tc Sensor 92 applied on the earlobe, the cheek or the forehead of pediatric (TCM5 Monitor) or adult patients. On other conventional measuring sites (TCM5 Monitor) only tcpCO2 can be monitored in pediatric or adult patients. • carbon dioxide partial pressure (TCM5 Monitor) and oxygen partial pressure (TCM5 Monitor) using the tc Sensor 84 applied subclavicular, on the abdomen, upper arm, forearm, inner and outer thigh or back of neonate, pediatric or adult patients. Additional application sites for pediatric and adult patients are chest, laterally on the neck and on the forehead. • carbon dioxide partial pressure (TCM5 Monitor) using the tc Sensor 54 applied on the earlobe, cheek, forehead of pediatric or adult patients. On other conventional measuring sites tcpCO2 can be monitored in neonate, pediatric or adult patients. With the Flex licence, the TCM5 Basic Monitor can be upgraded to a TCM5 Flex Monitor. The following sensors can be connected: tc Sensor 92 (TCM5 Monitor), tc Sensor 54 (TCM5 Monitor) or tc Sensor 84 (TCM5 Monitor)
Transcutaneous Monitoring System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000584_e22a2afba2f5e44cf5fcd61e6836d63d_fa2e24e4aa7592bc3baa4e57b43b30f0. This device is marketed under the brand name TCM5 Monitor. The license holder is DHR Holding India Pvt. Ltd,, and it is classified as Device Class Class B. The approving authority is CDSCO.
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