How the HEMOdialert™ alarm works


HEMOdialert hemodialysis alarm with HEMOsensor - detect blood leaks

HEMOdialert™ with HEMOsensor™

The HEMOdialert™ alarm and HEMOsensor™, will detect a blood leak from the fistula site of less than 1mL in 1 to 2 seconds or less1. They can can also detect other body fluids such as perspiration.

The HEMOsensor™ is a unique, patented, injection moulded, plastic, reusable sensor. It is placed over the fistula site and taped in place. It is impervious to blood and other fluids and so can be reused after cleaning with alcohol or any proprietary antibacterial/antiviral cleaner (avoid bleach, this will damage the special plastic).

The HEMOdialert™ alarm responds to small amounts of blood on the HEMOsensor™, by emitting a loud alarm at approximately 3.3 kHz, a frequency that has been established as one to which the human ear is especially sensitive2.

For additional safety, when the HEMOsensor™ is plugged into the alarm for use, the alarm beeps to indicate that the battery level is sufficient to power the circuit. If during use the battery power reduces below a predetermined level (this has been established with a high degree of safety with regard to battery power required to operate the alarm), then the alarm will beep at 10 second intervals to warn of the need to replace the batteries.

While the HEMOsensor™ is reusable, over time (e.g., after 6-9 months), the flexing of the wires may require it to be replaced. For this reason a spare sensor is supplied with the package.


Safety and Usability

The HEMOdialert™ has been tested for performance3. In a clinical environment it meets electrical, mechanical and ergonomic safety requirements for the user4 5, and conforms with electromagnetic compatibility6. It is also designed for ease of use7.

Full instructions come with the HEMOdialert™.


Even though the Hemodialert does not come within the definition of a medical device for regulatory purposes, it has been designed to meet the following standards:

  1. UL International Report No 13870A 16 July 2008: Anzacare Body Fluid Detection Alarm with Reusable Plastic Sensor Model: HEMOdialert.
  2. ISO 226:2003 Acoustics -- Normal equal-loudness-level contours
  3. UL International Report No 13870A 16 July 2008: Anzacare Body Fluid Detection Alarm with Reusable Plastic Sensor Model: HEMOdialert.
  4. IEC/ EN 60601-1:2006 Medical Electrical equipment. Part 1: General requirements for basic safety and essential performance.
  5. ISO 14971:2007 Medical devices - Application of risk management to medical devices
  6. IEC/EN 60601-1-2: 2006 and 2007. Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.
  7. IEC 60601-1-6: 2006 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
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