|US FDA sec. 864.5200 ; Automated Cell Counter.|
|(a) Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient’s peripheral blood (blood circulating in one of the body’s extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.
(b) Classification. Class II (performance standards).
Acme Revival has specific procedures, refurbishment guidelines, and quality testing protocols for Automated Cell Counters
All Automated Cell Counters undergo specific quality controls to ensure your refurbished device is safe, effective, and operating to the specifications designated by the manufacturer.
1). Cycle Counts are determined, and refurbishment is largely pending prior use
Most automated cell counters provide detailed reporting as to the prior use of the machine. Acme Revival does not fulfill devices that exceed the public recommended usage set forth by the manufacturer.
2). The system’s “Baths” are cleaned
The Bath assembly is cleaned, followed by calibration verification of MCV, RBC, WBC (control) counts.
3). The system’s “Probe Wipe Block” is flushed
The system’s probe wipe block is flushed, cleaned, and returned to factory specifications.
4).Tubing is replaced or cleaned with Benzene and Propylene
All internal tubing is examined, cleaned, and replaced if necessary. Dried, or cracked tubing is replaced with new material if originally installed greater than 3 years ago.
5). “Vacuum Isolator Chamber” is cleaned and flushed
If there is persistent buildup under the top, causing Plt and WBC noise problems, the unit will be replaced.
6). “Waste Filter” is flushed, or replaced
If back-up or failure is observed, the filter will be replaced, entirely.
7). The “Aperture” is zapped, proceeding with calibration if control values or counts are erratic.
Aperture zapping is only performed if the unit provides a self-zapping function.
¹Acme Revival may not perform any additional refurbishment, repair, or cleaning than what is listed above. It is ultimately the responsibility and duty of the clinician to verify, daily, that their device is properly working and to ensure safe patient use per the manufacturer’s specifications. Regular maintenance should be performed as detailed in the manufacturer’s official operator/user manual, and, as indicated by this official document, regular self-calibrations, cleanings, and self-checks should be performed.