Avoximeter Whole Blood Oximeter
ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Model AVOX1000E
Avoximeter Whole Blood Oximeter System - Instrument
Intended use: A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Co-oximetry analyser IVD, point-of-care
- FDA product classification
- Oximeter
- Manufacturer support
- 1-800-678-0710 · ilsd_ra.na@werfen.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
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