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The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.

The FAST Sphyg by Koven is an aneroid sphygmomanometer that uses the auscultatory blood pressure technique in combination with a stethoscope or Doppler and occluding cuff to determine systolic and diastolic blood pressure measurement. The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.

The provided text describes the FAST Sphyg by Koven, an aneroid sphygmomanometer intended for indirect measurement of arterial blood pressure. The document focuses on establishing substantial equivalence to a predicate device and adherence to relevant performance standards.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

   The document does not present a single, consolidated table explicitly labeled "acceptance criteria" and "reported device performance" in the context of clinical accuracy for blood pressure measurement. Instead, it refers to compliance with performance standards, primarily ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.

   However, the document lists other technical standards that the device meets, which can be considered acceptance criteria for electrical safety and electromagnetic compatibility:

   Standard / Test	Acceptance Criteria / Test Level	Reported Device Performance / Compliance Level
   ISO 81060-1:2007	Requirements and test methods for non-automated measurement type	Designed and tested to meet this standard. (Specific accuracy metrics not detailed in this excerpt)
   IEC 60601-1 (2007) - Electrical Safety	Class II device (Protection class against electric shock)	Class II device, Internally powered equipment
   	Type B applied part (Protection grade against electric shock)	Type B applied part
   IEC 60601-1-2 (2007) - Electromagnetic Emissions
   RF Emissions CISPR 11	Group 1	Group 1
   RF Emissions CISPR 11	Class B	Class B
   Harmonic Emissions IEC 61000-3-2	Class A	Class A
   Flicker Emissions IEC 61000-3-3	Not Applicable	Not Applicable
   IEC 60601-1-2 (2007) - Electromagnetic Immunity
   Electrostatic Discharge (ESD) IEC 61000-4-2	±6kV Contact, ±8kV Air	±6kV Contact, ±8kV Air
   Electrical Fast Transient/burst IEC 61000-4-4	±2kV for power supply lines, ±1kV for input/output lines	±2kV for power supply lines, ±1kV for input/output lines
   Surge IEC 61000-4-5	±1kV differential mode, ±2kV common mode	±1kV differential mode, ±2kV common mode
   Voltage dips, short interruptions, and variations

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