↩️ return to all refurbishment procedures

 

US FDA sec. 870.1130 ; NIBP, SpO2, Temperature, Vitals Monitor
(a) Identification. Vital Signs Monitors are devices that take constant or periodic measurements of the body’s most basic functions. The four main vital signs routinely monitored by medical professionals and health care providers include the following: Body temperature. Pulse rate. Respiration rate (rate of breathing), and Blood Pressure.

(b) Classification. Class II (performance standards).

 

Acme Revival has specific procedures, refurbishment guidelines, and quality testing protocols for Patient Monitors.

All Patient Monitors undergo specific quality controls to ensure your refurbished device is safe, effective, and operating to the specifications designated by the manufacturer.

 

1). Voltage currents and other frequencies are determined to ensure safety

All devices must be properly grounded, and demonstrate voltage and frequencies per the manufacturer’s specifications.

 

2). Respiration saturation rates (SpO2) calibration are verified

An automated and portable device is used to determine accuracy of SpO2 rates by setting the following baseline simulations:

Respiration Rate: 0 (Apnea), 15, 20, 30, 40,  60, 80, 100, 120 and 150 R/MIN
Impedance: 0.2, 0.5, 1.0 and 3.0 Ω
Baseline  impedance: 500, 1000, 1500, 2000Ω
Apnea: 12 s, 22 s, 32 s

The device must accurately read, display and record each baseline.

Further, the following tests are performed:

Reaction time of the device
SpO2 and pulse rate are simulated under different amplitudes
Different R-curves are selected

 

3). NIBP value (Blood Pressure) calibration is verified

An automated and portable device is used to determine accuracy of NIBP values by setting the following baseline simulations:

 

  1#: BP: 120/80(93) HR: 80 Pulse Volume:  0.68

  2#: BP: 150/100(116) HR: 80 Pulse  Volume: 0.65

  3#: BP: 200/150(166) HR:  80 Pulse Volume: 0.60

  4#: BP:  255/195(215) HR: 80 Pulse Volume: 0.55

  5#: BP: 60/30(40) HR: 80 Pulse Volume:  0.75

  6#: BP: 80/50(60) HR: 80 Pulse  Volume: 0.71

  7#: BP: 100/65(76) HR: 80  Pulse Volume: 0.69

Neonatal simulations are then performed if applicable to the specific device:
  1#: BP: 35/15 HR: 120bpm  Pulse Volume: 0.11
  2#: BP: 60/30 HR:  120bpm Pulse Volume: 0.10
  3#: BP:  80/50 HR: 120bpm Pulse Volume: 0.10
  4#: BP: 100/70 HR: 120bpm Pulse Volume:  0.10

 

The device must accurately read, display and record each baseline.

 

4).Real-time pulse values and rates are verified

24 conditions between 25bpm~250bpm are presented using an automated and portable device to determine accuracy of real-time pulse values.

The device must accurately read, display and record each baseline within ±2bpm

 

5).Real-time temperature values are verified

Four temperature values of: 0℃(32°F), 24℃( 75°F),  37℃(98.6°F), 40℃(104°F) ;

are presented using an automated and portable device to determine accuracy of patient temperature.

 

 

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.