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ANSPACH

 

EG1

TM

 WIRELESS HAND CONTROL SYSTEM

 

 

General Information 

 

Device Description 

The eG1 Wireless Hand Control System consists of the non-sterile 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 the cranium and spine. 

 

Indications for Use 

The eG1 High Speed System is indicated for cutting and shaping bone including the cranium and spine. 

 

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.

 

 

Catalog number & Compatibility 

Catalog 
Number 

Consoles 

Handpiece 

SC3001 

SC3002 

EG1A 

RECEIVER-HC 

 

 

 

WIRELESS-HC  
 

 

 

 

Summary of Contents for ANSPACH EG1

Page 1: ...d for cutting and shaping bone including the cranium and spine Contraindications The eG1 High Speed System does not have any known product specific contraindications Potential Adverse Events As with a...

Page 2: ...ction 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 orig...

Page 3: ...its packaging is compromised Visually inspect device components for damage before using do not use if damage or wear is evident unrecognizable markings missing or removed part numbers corrosion etc M...

Page 4: ...rical Equipment Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the eG1 system Othe...

Page 5: ...e field Caution Do not push receiver connector into console connector port when out of alignment Figure 1 Receiver connects to the foot control connector port on console SC3001 or SC3002 3 Remove the...

Page 6: ...dpiece and release pressure on button to decrease speed of handpiece Warning Keep hand control safety cover in locked position when not in use Figure 5 Hand control cover shown in unlocked position 6...

Page 7: ...st All Instrument System components returned should be properly cleaned as applicable prior to shipping to the manufacturer Warning Transmissible Spongiform Encephalopathies TSE DePuy Synthes Power To...

Page 8: ...ator will be solid blue Out of Range The blue light indicator will blink with a fast flash when device is out of range or the signal is lost due to interference Hand Control Battery is at FULL Capacit...

Page 9: ...ure device maintain a minimum distance between portable and mobile RF communications equipment transmitters and the eG1 System as recommended in the Recommended separation distances between portable a...

Page 10: ...mmunication Apparatus All Frequency Bands Concurrently with FCC Part 15 247 IC ICES 003 2016Ed 6 Information Technology Equipment Including Digital Apparatus Limits and Methods of Measurement Concurre...

Page 11: ...e IEC 60601 1 6 Issued 2013 10 29 Ed 3 Medical Electrical Equipment Part 1 6 General Requirements for Basic Safety and Essential Performance Collateral Standard Usability Amendment 1 IEC 60601 1 2005...

Page 12: ...tic establishments and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluc...

Page 13: ...r 25 periods 50Hz 30 periods 60Hz Interruptions 0 UT 100 dip in UT for 250 periods 50Hz 320 periods 60Hz Mains power quality should be that of a typical commercial or hospital environment If the user...

Page 14: ...magnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3...

Page 15: ...M 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse Modulation b 217 Hz 2 0 3 28 5 240 5 100 5 80...

Page 16: ...stimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At...

Page 17: ...DePuy Synthes Representative for more information All DePuy Synthes Implant Instructions for Use as well as general Instructions for Use are available as PDF files at www e ifu com www depuysynthes c...

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