Chlorine Sentinel II

The Chlorine Sentinel II is a secondary chlorine monitoring system for hemodialysis water treatment that detects dissolved combined chlorine at concentrations of 10 PPB or above. It attaches to a hemodialysis water treatment system sample port and is not intended to replace the primary chlorine monitoring method.

The device uses the same direct measuring polarographic sensor with special polymeric membrane as the predicate, detects the same type of chlorine (dissolved combined chlorine), and has the same chlorine level alarm at 0.1 mg/L. Key differences include replacement of mechanical push buttons with a PLC and color touch screen, consolidation into a single enclosure instead of two, addition of a user-configurable warning set-point (0.01–0.09 PPM), adjustable sampling rates (5–30 minutes instead of continuous), and inclusion of a water shut-off device.

IEC 61010-1 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use), IEC 60601-1-2:2020 Edition 4.1 (Medical Electrical Equipment—Electromagnetic compatibility), CLSI standard EP06-A (Linearity Study), and CLSI standard EP17-A2 (Limit of Blank, Limit of Quantitation, Limit of Detection Study). ISO 14971:2007 was used for risk analysis.

The Chlorine Sentinel II has the same indications for use as the predicate (detection of chlorine in water for hemodialysis dialysate preparation) and uses identical core detection technology and chemistry. Although the user interface is modernized via PLC and touch screen and operational features are enhanced (scheduling, configurable warning setpoint, reduced water consumption), these modifications do not alter the fundamental sensing mechanism, chlorine type detected, detection range, or primary alarm threshold. Both devices are FDA-cleared and function as secondary monitors, making the device as safe and effective as the legally marketed predicate.