Background and Identification

The Respironics BiPAP Focus (Model Number:8-400258-00), is a non-invasive ventilatory system that was released in 2006. The Respironics BiPAP Focus is a hospital grade ventilator that includes features such as a large screen, backup batteries, portable design, adjustable alarms, and nurse calls. This device is distributed worldwide and is meant for hospital use, but can also be used in home care.

In 2008 on September 22nd, the manufacturer issued a Class 1 recall on the device, citing a power supply failure related to power cord connection and possible power surges. The recall status was terminated on July 10th, 2010.

This ventilator has a large screen interface and is constructed with a white/grey plastic exterior and weighs in at 10 lbs (4.5 kg). The device is a portable utilizing a smaller design with a width of 11.4 inches, depth of 14 inches, and a height of 5.5 inches.



Source: Class 1 Recall Status

Technical Specifications

Controls

  • CPAP: 4-20 cm H2O
  • EPAP: 4-25 cm H2O
  • IPAP: 4-30 cm H2O
  • Rise Time: 1-6 (1 = 0.1 s and 6 = 0.6 s)
  • Rate: 1-30 BPM (accuracy: ±BPM or ±10% of setting)
  • I-time: 0.5-0.3 s
  • Ramp Time: 0-45 min
  • Ramp Start: 4 cm H20 to EPAP
  • Maximum Flow Capacity: 160 l/min
  • Leak Compensation: Up to 60 l/min

Dimensions

  • Height: 5.5” (14 cm)
  • Width: 11.4” (29 cm)
  • Depth: 14” (35.5 cm)
  • Max Weight: 10 lbs (4.5 kg)

Patient Parameters

  • Patient Circuit Pressure: 0-35 cm H2O
  • Rate Range: 0-99 BPM
  • Estimated VT Range: 0-4000 ml
  • Estimated MV Range: 0-99 l/min
  • Patient Leak Range: 0-200 l/min
  • Apnea Rate Range: 0-99 per hour

Alarms

  • High System Pressure: 5 cm H2O over target IPAP pressure
  • Low System Pressure: 5 cm H2O under target EPAP pressure
  • Apnea Range: 20, 40, 60s or off
  • Apnea Rate Range: 5, 10, 20 apneas per hour or off
  • Nurse Call: Normally open, normally closed

Electrical

  • Input Rating: 100 VAC / 230 VAC
  • Battery Backup: 3.8 amp-hour (NiMH)
  • Fuse: No replaceable fuse
  • Nurse Call: 0.280 A (rated current); 250 V (rated voltage)

Source: Respironics BiPAP Focus Specs

Additional Information

FDA Product Recall Status Document

Soma Technologies Product Specifications

Philips Respironics BiPAP Focus Product Page