Endoflip
Covidien LP · Model EF-301
300 Pump System With Pre-Use Tube
Intended use: An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.
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
- Storage Environment Temperature
- -30°C to 60°C
- Handling Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- Handling Environment Temperature
- 20°C to 40°C
- Handling Environment Humidity
- 15 Percent (%) Relative Humidity to 95 Percent (%) Relative Humidity
- Storage Environment Humidity
- 15 Percent (%) Relative Humidity to 95 Percent (%) Relative Humidity
- 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)
- Manometric gastrointestinal motility analysis system
- FDA product classification
- SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
- Manufacturer support
- +1(508)261-8000 · covidien.udi@covidien.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.
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