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Table of Contents
Related Manuals for Invuity PhotonBlade
Summary of Contents for Invuity PhotonBlade
- Page 1 ® PhotonBlade Instructions for Use MANUFACTURER Invuity, Inc. 444 De Haro Street San Francisco, CA 94107 USA Tel: 866.711.7768 www.invuity.com Consult Instructions for Use and Symbols Glossary on this website: www.invuity.com/documentlibrary IFU 12296 Rev C Invuity Customer Service: 866.711.7768...
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Page 2: Indications For Use
The PhotonBlade consists of a single blade with a rotatable and adjustable length shaft. It is designed to be used with a 510(k) cleared electrosurgical unit (ESU). The PhotonBlade is operated by use of an integrated hand switch or ESU footswitch similar to an electrosurgical pencil. - Page 3 • Do not touch the blade or telescoping shaft assembly while the Cut or Coag function is activated, as this may result in injury. • Do not contact metal objects or instruments with the PhotonBlade while the Cut or Coag function is activated, including sutures, staples or clips, as this may cause patient or user injury, tissue damage, or damage to the device.
- Page 4 • Avoid fluid contact with the device hand switch, as this may cause damage to the device. • Do not use the PhotonBlade on small appendages, as monopolar electrosurgery may cause thrombosis or unintended tissue injury.
- Page 5 2. Inspect the device package before use. Do not use if the device or packaging has been opened or damaged. Remove the PhotonBlade from the package and inspect the tip of the device for damage. Do not use if damaged.
- Page 6 2. To collapse the shaft of the device, loosen the nose cone, push on the shaft to the desired length, then tighten the nose cone. 3. Adjust the length and rotation of the PhotonBlade shaft as needed throughout the procedure.
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Page 7: Battery Replacement
10. Keep the waveguide clean throughout the procedure. Remove fluid or debris with a tapered swab. Battery Replacement: 1. The PhotonBlade will provide approximately 2 hours of illumination. If the battery needs to be replaced: a. Turn OFF the ESU and unplug the device from the ESU. -
Page 8: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below. The customer or user of the Invuity PB1 PhotonBlade should ensure that it is used in such an environment. - Page 9 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Invuity PB1 PhotonBlade is intended for use in the electromagnetic environment specified below. The customer or the user of the Invuity PB1 PhotonBlade should assure that it is used in such an environment.
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Page 10: Warranty
Warranty INVUITY warrants, for the earlier of (i) the expiration date, if applicable, or (ii) one (1) year from the date of purchase, that this medical device is free from defects in both material and workmanship when used normally for its intended purposes. Suitability of the medical device for any surgical procedure shall be determined by the user alone (in light of relevant instructions for use) and not by INVUITY, and such user shall be responsible for understanding how to use the device for its intended purpose. -
Page 11: Document Number
Added "During use, do not allow the illumination 12/09/16 12/12/16 J. Hegener output surface of the PhotonBlade to be obstructed. The high intensity illumination has the potential to cause thermal damage or injury if the output surface is obstructed by tissue, gloves, or other material."... -
Page 12: Printing Instructions
Document Number Page 12 of 12 IFU 12296 Rev C INSTRUCTIONS FOR USE PhotonBlade PRINTING INSTRUCTIONS Print in-house or at an approved supplier. Do not print Revision History or Printing Instructions pages (page 11 & 12). Print double sided, booklet style in black ink on white paper.
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