Olympus
Gyrus ACMI, LLC · Model PK-AI2055
PK ADVANCED INTERGRATED MULTIFUNCTIONAL DEVICE (5/PK, For use with ESG 400 Generator Only)
Intended use: A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.
Key tips
- ·Never defeat or bypass a return-electrode monitoring (REM) alarm to finish a case - it's a direct burn risk.
- ·Verify OR table battery backup - a table that loses power mid-procedure is a real, documented incident type.
- ·Track surgical light lamp-hours rather than waiting for failure - a sudden failure mid-case is avoidable.
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.
- ·Pre-case functional check
- ·Electrosurgical return-electrode cable inspection
- ·Table hydraulic / mechanical inspection
- ·Annual electrical safety test and full PM
Technical Specs
- Handling Environment Temperature
- -29°F to 50°F
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Flexible endoscopic biopsy forceps, single-use
- FDA product classification
- Electrosurgical, Cutting & Coagulation & Accessories
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Operating rooms
- Procedure rooms
- Interventional suites
Documents & Manuals
No documents available for this device yet.
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