DePuy Synthes

ANSPACHTM EG1TM WIRELESS HAND CONTROL SYSTEM

14 Pages

ANSPACH™ EG1™ WIRELESS HAND CONTROL SYSTEM General Information Device Description The eG1™ Wireless Hand Control System consists of the nonsterile reusable Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) and the disposable Wireless Hand Control, EG1A (WIRELESS-HC) which is provided in a sterile package configuration. The Wireless Hand Control, EG1A communicates wirelessly through the Receiver for Wireless Hand Control, EG1A to allow the user to regulate the speed of the eG1 High Speed System.  Intended Use The eG1 High Speed System is intended for cutting and shaping bone including spine and cranium.  Indications for Use The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.  Contraindications The eG1 High Speed System does not have any known product specific contraindications.  Potential Adverse Events As with all major surgical procedures, risks, side effects and adverse events can occur. The following potential adverse events can occur: • Infection • Adverse Tissue Reaction • Injury to Patient • Injury to User  Intended User This device is intended to be used by qualified health care professionals e.g. surgeons, physicians, operating room staff, and individuals involved in preparation of the device.  Patient Target Group The eG1 Wireless Hand Control System is for use with patients undergoing surgery where the cutting and shaping of bone, including bones of the cranium and spine, is desired.  DePuy Synthes  Catalog number & Compatibility Consoles Catalog Number  SC3001  SC3002  RECEIVER-HC      Handpiece  WIRELESS-HC  EG1A    ■ Note: DePuy Synthes has not tested compatibility with devices provided by other manufacturers and assumes no liability in such instances.  Cleaning and Sterilization  Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Receivers are non-sterile capital equipment and shall always be maintained outside the Operating Room Sterile Field. ▲ Warning: Do not immerse or sterilize the receiver. 1. Disconnect receiver from console. 2. Clean the receiver thoroughly by wiping with non-abrasive cloth and neutral pH detergent and deionized, distilled, or purified water after each case. 3. Dry thoroughly with non-abrasive cloth. 4. Visually inspect the device. If any visible soil remains, repeat steps 2 and 3 with new cloth. Wireless Hand Control, EG1A (WIRELESS-HC) ▲ Warning: Do not reprocess the Hand Control. The Hand Control is disposable and SINGLE USE ONLY. Reprocessing the hand control may result in loss of function causing delay in surgery. The Hand Control is provided sterile. Remove product from the package using established operating room procedures for sterile transfer. Store sterile devices in their original protective packaging, and do not remove them from the packaging until immediately before use. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use if the package is damaged.  EG1™ WIRELESS HAND CONTROL SYSTEM •  Page 1 of 14
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File Name: DePuy Synthes - Johnson & Johnson - 0000314957 - ANSPACHTM EG1TM WIRELESS HAND CONTROL SYSTEM - 2022-05 - Rev A.19.pdf

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