Nonin SenSmart™ Model X-100 Universal Oximetry System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Suntime Singapore Pte Ltd

Class:

Class C medical device

Manufactured by:

NONIN MEDICAL INC

Therapeutic area:

General Hospital

Therapeutic indications:

Nonin’s SenSmart™ Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack], Nonin’s SenSmart Model X-100 Universal Oximetry System is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to 6 channels of oxygen saturation of cerebral or somatic hemoglobin (rSO2) & arterial hemoglobin (SpO2).; Models: SenSmart Universal Oximetry System - X-100-010200001, X-l00 SenSmart Universal Oximetry Monitor, (Software Version 1.0) - 8644-003, SenSmart System Hub, X-100H - 8646-001, SenSmart Hub Holster, X-100HH - 8662-001, SenSmart Signal Processor Channel 1, X-100SP-1 (Software Version 2.0) - 8650-001, SenSmart Signal Processor Channel 2, X-100SP-2 (Software Version 2.0) - 8650-002, SenSmart Signal Processor Channel 3, X-100SP-3, (Software Version 2.0) - 8650-003, SenSmart Signal Processor Channel 4, X-100SP-4, (Software Version 2.0) - 8650-004, SenSmart Signal Processor Channel 5, X-100SP-5, (Software Version 2.0) - 8650-005, SenSmart Signal Processor Channel 6, X-100SP-6, (Software Version 2.0) - 8650-006, SenSmart Color Cable Identifier - 8841-001, SenSmart 1 meter extension cable, X-100EC-1 - 8445-001, SenSmart 2 meter extension cable, X-100EC-2 - 8445-002, SenSmart INT-100 Intermediate Cable - 10535-001, SenSmart Download Software, CD ROM, (Software Version 1.0) - 8742-003, SenSmart Sensor Lock - 9390-001, X-100 SenSmart Oximetry System - 8367-001, SenSmart Sensor 8204CA - 10433-001, SenSmart Sensor 8204CA - 10431-001, SenSmart Sensor 8004CB-Non Adhesive - 9750-001, SenSmart Sensor 8004CB-Non Adhesive - 10410-001, SenSmart Sensor 8004CB - 9749-001, SenSmart Sensor 8004CB - 10409-001, SenSmart Sensor 8100SS - 8703-001, SenSmart Sensor 8100SM - 8705-001, SenSmart Sensor 8100SL - 8534-001

Authorization date:

2018-06-14