AbbVie VYAFUSER - Page 60

60 Technical Specications
Technical Features
The pump has the following primary mitigations against under-
infusion:
• Required conrmation of all delivery rates and volumes set by the
healthcare professional.
• Required conrmation of all delivery rates selected by the user.
• Occlusion detection
• Independent circuitry that checks against malfunctioning software or
hardware.
The pump has the following primary mitigations against over-
infusion:
• Maximum programmable rates are consistent with expected patient
needs.
• Required conrmation of all delivery rates and volumes set by the
healthcare professional.
• Required conrmation of all delivery rates selected by the user.
• Independent circuitry that checks against malfunctioning software or
hardware.
Note: Maximum volume infused under single fault conditions:
If the pump malfunctions in an over-infusion condition at a delivery
rate of less than 6.5 mL/hr, the safety circuit will not detect the over-
infusion. During this condition, the entire syringe volume (up to 11 mL)
would be delivered at that rate.
Description of pump occlusion threshold:
1. Prevention of the pressure in the syringe exceeding 200 kPa.
2. Detecting syringe pressure increase if line is occluded at pressures
below 200 kPa.
Sound Pressure Level:
The high priority alarm has a sound pressure level range from 50 dBA
to 67 dBA at 1 meter. The low priority alarm has a sound pressure level
range from 49 dBA to 62 dBA at 1 meter.