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Guidance and manufacturer’s declaration –

electromagnetic immunity

 

The 

eG1 System

 is intended for use in the electromagnetic environment specified below. The customer or the user of the 

eG1 

System 

should assure that it is used in such an environment.  

Immunity test

 

IEC 60601 test level

 

Compliance level

 

Electromagnetic environment 

 

guidance

 

Conducted RF 
IEC 61000-4-6 

3 Vrms 
150 kHz to 80 MHz 
 
6 Vrms in ISM bands 
150 kHz to 80 MHz 

3 Vrms 
150 kHz to 80 MHz 
 
6 Vrms in ISM bands 
150 kHz to 80 MHz 

 
Portable and mobile RF communications equipment should 
be used no closer to any part of the eG1 System, including 
cables, than the recommended separation distance 
calculated from the equation applicable to the frequency of 
the transmitter. 
 

Recommended separation distance  
 

P

d

2

.

1

=

 

P

d

2

.

1

=

 

 

80 MHz to 800 MHz

 

P

d

3

.

2

=

  800 MHz to 2,5 GHz

 

 

where 

is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter 
manufacturer and 

d

 is the recommended separation 

distance in meters (m).  

Field strengths from fixed RF transmitters, as determined by 
an electromagnetic 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 

3 V/m 
80 MHz to 2,7 GHz 
 
80% at 1kHZ (AM 
modulation) 

3 V/m 
80 MHz to 2,7 GHz 
 
80% at 1kHZ (AM 
modulation) 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.  

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection 
from structures, objects and people.  

a

 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, 
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the 
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the 
measured field strength in the location in which the eG1 System is used exceeds the applicable RF compliance level above, 
the eG1 System should be observed to verify normal operation. If abnormal performance is observed, additional measures 
may be necessary, such as re-orienting or relocating the eG1 System. 

b

   Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.  

 
 

 

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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