Synthes ANSPACH EG1 User manual

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ANSPACH™EG1TM 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
●

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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 receiver 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.
Wireless Hand Control, EG1A (WIRELESS-HC)
Warning: Do not reprocess the Hand Control. Hand Controls are disposable and SINGLE USE ONLY.
Reprocessing hand controls 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.
Explanation of Symbols Used
General Symbols
Direction of motion
Reference or Catalogue Number
(Ref. 5.1.6 ISO 15223-1)
Consult Instructions for Use
(Ref. 5.4.3 ISO 15223-1)
Materials
Caution: United States Federal law
restricts this device to sale by or on
the order of a physician or other
licensed health-care provider
(21 CFR 801.109)
Date of Manufacture
Manufacturer (Ref. 5.1.1 and 5.1.3
ISO15223-1)
Product is ETL listed to the
requirements of US and Canada
Keep dry (Ref. 5.3.4 ISO 15223-1)
Locked
Do not use if package is damaged.
(Ref. 5.2.8 ISO 15223-1)
Unlocked

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Non-ionizing electromagnetic
radiation. (IEC 60417-5140)
Transmitter Interference may occur
in the vicinity of equipment marked
with this symbol.
CAUTION (Ref. 5.4.4 ISO 15223-1)
Non-Sterile
Ref. 5.2.7 ISO 15223-1
Made in
Single sterile
barrier system
with protective
packaging inside (Ref. 5.2.13 ISO
15223-1)
Packaging Unit - Indicates the number
of pieces in the package (ISO 7000-
2794)
Sterilized using ethylene oxide (Ref.
5.2.3 ISO 15223-1)
Unique Device Identifier
Use-by Date (Ref. 5.1.4 ISO 15223-
1)
Lot or Batch Number (Ref. 5.1.5 ISO
15223-1)
Temperature Limit ((Ref. 5.3.7 ISO
15223-1)
Humidity Limitation (Ref. 5.3.8 ISO
15223-1)
Ingress protection rating according
IEC 60529
Do not re-use (Ref. 5.4.2 ISO 15223-1)
FCC Symbol
Follow instructions for use (ISO 7010-
M002)
Warnings
•Surgeon is responsible for learning proper
techniques in use of equipment; improper
use may cause serious injury to user or
patient or damage to system.
•Instrument operator and all operating room
personnel must wear eye protection.
•Do not use if product package has been
damaged or opened.
•Do not use if the product sterilization barrier
or 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.).
•MR Unsafe—Not for use in Magnetic
Resonance Imaging (MRI) environments.
•Do not use excessive force.
•Wireless Hand Control, EG1A is disposable
and intended for single patient use only.
•Do not re-sterilize or reuse Wireless Hand
Control, EG1A: reuse and/or re-sterilization
•Do not modify. Modifications could result in loss of
electrical safety.
•Faulty devices must not be used. Refer to the
section “Disposal of Waste”.
•Do not operate in an explosive flammable
environment.
•Wireless Hand Control, EG1A is only compatible
with eG1 Handpiece and Console (SC3001,
SC3002). Using other than indicated high speed
system may lead to injury.
•Receiver for Wireless Hand Control, EG1A and
console must be maintained outside sterile field.
•Keep Wireless Hand Control, EG1A safety cover in
locked position when not in use
•Medical Electrical Equipment needs special
precautions regarding Electromagnetic
Compatibility (EMC) and needs to be installed and
put into service according to the EMC information
provided in this accompanying documentation.
•The emissions characteristics of this equipment
make it suitable for use in industrial areas and

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of the hand control could result in reduced
performance, material degradation, and/or
patient contamination.
•Do not immerse or sterilize Receiver for
Wireless Hand Control, EG1A.
•Do not use in oxygen rich environment.
•Dispose of items contaminated with body
fluids with other biohazardous waste.
•At end of life recycle or dispose of device in
accordance with local and national
regulations.
•Verify that the Wireless Hand Control, EG1A
is connected to the intended Receiver for
Wireless Hand Control, EG1A. If the receiver
controlling the console is paired to an
unintended hand control, disconnect the
receiver from the EG1 console to prevent
unintended motion of the handpiece.
hospitals (CISPR 11 class A). This equipment
generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance
with the instruction manual, may cause harmful
interference to radio communications.
•Operation of this equipment in a residential area
(for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection
to radio frequency communication services.
•In the event of interference, the user might need to
take mitigation measures such as relocating or
reorienting the equipment.
•Portable and Mobile Radio Frequency (RF)
communications equipment can affect Medical
Electrical 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. Otherwise,
degradation of the performance of this equipment
could result, including intermittent loss of function
or inability to pair the device.
Precautions
•United States Federal law restricts this
device to sale by or on order of a physician
or other licensed healthcare provider.
•Do not use accessories other than those
provided by DePuy Synthes Power Tools
and specified for use with Anspach Systems.
•To ensure equipment operates as designed,
read and follow manufacturer's instructions.
•Use care to protect when handling, cleaning, and
during system use.
•Do not push receiver connector into console
connector port when out of alignment.
Latex Information
Not made with natural rubber latex.
Wireless Hand Control Set Up
Prior to first use the equipment (EG1A) must be processed as per the included EG1 High Speed System Cleaning
and Sterilization instructions.
1. Inspect the equipment prior to use
Warning: Wireless Hand Control System is only compatible with eG1 Handpiece (EG1A) and Console (SC3001,
SC3002). Use with other than the indicated high speed system may lead to injury or damage to product.
EG1A
Visually inspect for damage to the silicone hose or to the
electrical connector.
Connect to console and operate.
The handpiece should operate smoothly.
There is no requirement to operate with attachment or
dissection tool.

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SC3001
Visually inspect for damage or cracks to the housing. Visually
inspect for damage to the electrical power cord. Power the
system and inspect for illumination of the LEDs. If there is an
irrigation pump present, check for proper function.
SC3002
2. Insert Receiver for Wireless Hand Control, EG1A into foot control connector port on front of console (SC3001
or SC3002) with red dot on connector facing up. See Figure 1.
Warning: Receiver and console must be outside sterile 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 Wireless Hand Control, EG1A from packaging and attach the hand control onto the eG1A
handpiece. See Figure 2.
Warning: Keep hand control safety cover in locked position when not in use.
Figure 2: Attach hand control onto the eG1A handpiece
4. Pair Handpiece. Press and release the button on the receiver (See Figure 3) and the hand control (See Figure 4)
within 30 seconds to complete the pairing. When pairing is complete you will see the blue light go from flashing to
solid on the receiver.

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Figure 3: Push button on the receiver
Figure 4: Push button on the hand control
5. Start operation: Unlock the hand control, grab the battery pull tab and remove it by pulling in the direction
indicated by the arrow and press button on the hand control to start handpiece. Increase pressure on button to
increase speed of handpiece 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. Stop Operation: Lock the wireless hand control and unpair the device. To unpair the device simply press receiver
button or unplug receiver from console.
Warning: Do not re-sterilize or reuse hand control: reuse and/or re-sterilization of hand control could result in
reduced performance, material degradation, and/or patient contamination.

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End of Life
Wireless Hand Control, EG1A (WIRELESS-HC)
The hand control is a SINGLE USE only device. Product expiration date can be found on the device package label.
Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
The lifetime requirements of the receiver are event-related depending on the use and inspection of the device in
clinical practice. The lifetime of the device may be compromised following normal conditions of use such as, but not
limited to:
Damage, including but not limited to corrosion (e.g. rust, pitting), discoloration, scratches, flaking, cracks and
wear.
Excessive temperature during operation.
Improper function, including but not limited to inability to connect to console or failure to pair.
Missing, faded, or removed device markings.
Made obsolete or no longer in use.
Damage impeding the ability to inspect or use the device.
Service Lifetime
These devices do not require periodic service.
Warranty & Return Policies
Warranty and return policy are available upon request.
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 Tools will not authorize or accept the return of products that directly contact patients or are
contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform
Encephalopathies/ Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. DePuy Synthes Power Tools recommends
that all ANSPACH High Speed System products used on a patient confirmed with a TSE/CJD diagnosis be
incinerated. ANSPACH High Speed System Dissection Tools used on a patient suspected of TSE/CJD diagnosis
must be incinerated.
Contact your Sales Representative for replacement of product incinerated under this policy or for temporary
equipment while original equipment is quarantined. Contact the DePuy Synthes Power Tools Customer Service
Department regarding TSE/CJD contamination for additional information.
Receiver for Wireless Hand Control, EG1A Displays
Display
Result
Description
Not Paired
Press the pairing button on the
receiver and wait until light flashes
blue to initiate pairing.

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Pairing
The blue light indicator will “blink”
with a slow flash during parring.
Paired
The blue light indicator 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
Capacity
The battery indicator will not be ON.
Hand Control Battery is at <50%
Capacity
The battery indicator will be solid
red.

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Hand Control Battery is at <25%
Capacity
The Battery indicator will start
flashing red.
Trouble Shooting
Wireless Hand Control, EG1A (WIRELESS-HC)
Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
Trouble Shooting Chart
Problem
Possible Cause
Possible Solution(s)
Receiver LED does
not turn on when
plugged into
Console.
•Receiver not fully inserted
•Console not powered ON
•Ensure receiver is fully inserted in foot
pedal connector
•Ensure Console is Power ON
Cannot pair the
device
•Battery tab not removed from
hand control
•RF interference
•Dead battery on hand control
•Hand control was previously
paired with another receiver
•Ensure battery pull tab is removed on
•Repeat “Pairing Instructions” found on
set up section or ensure 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 and mobile RF
communications equipment and the
eG1 System " table
•Discard and replace receiver
•Discard and replace hand control (can
only be paired with one receiver)
Paired, but does not
actuate
•1.EG1 Handpiece is unlocked
(load) position
•Interference
•Ensure EG1 handpiece is in locked
(run) position
•Move equipment away from source of
interference
Device becomes
unpaired
•Lost connection due to possible
RF interference
•Battery failure
•Ensure 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 and mobile RF
communications equipment and the
eG1 System " table
•Discard and replace hand control

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Loss of Power
•Console power failure
•Ensure console in plugged in and
repeat “pairing instructions” found on
set up section.
Technical Specifications
FCC ID:
WIRELESS-HC: 2AYUW-WHC1
RECEIVER-HC: 2AYUW-RHC1
IC:
WIRELESS-HC: 27015-WHC1
RECEIVER-HC: 27015-RHC1
The devices comply with the following standards:
FCC 47CFR PT 15.247 Issued:2004/10/01
Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz.
All measurement performed in 10m chamber.
FCC 47CFR: (Part 15 Subpart B)
Title 47 CFR Part 15 Subpart B: Unintentional Radiators
Concurrently with FCC Part 15.247
RSS-247
Issue: 2015/05/22 Issue 1 Digital Transmission Systems (DTSs),
Frequency Hopping Systems (FHSs) and License-Exempt Local Area Network (LE-LAN) Devices
Concurrently with FCC Part 15.247
RSS 102:2015 Ed.5
Radio Frequency (Rf) Exposure Compliance of Radiocommunication
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
Concurrently with FCC Part 15.247
ETSI EN 300 328:2019 Ed.2.2.2
Wideband Transmission Systems; Data Transmission Equipment Operating in the 2,4 GHz band; Harmonized
Standard for Access to Radio Spectrum
ETSI EN301489-1:2017Ed. V2.1.1
Electromagnetic Compatibility (EMC) Standard For Radio Equipment And Services; Part 1: Common Technical
Requirements; Covering The Essential Requirements Of Article 3.1(B) Of Directive 2014/53/Eu And The
Requirements Of Article 6 Of Directive 2014/30/Eu
Includes:
ETSI EN 301 489-17 V3.1.1 (2017-02)
ETSI EN 303 446-1 V1.2.1 (2019-07)
EN IEC 62311:2020 Testing and/or Evaluation
Receiver for Wireless Hand Control, EG1A and Wireless Hand Control, EG1A intentionally receive RF
electromagnetic energy for the purpose of its operation:
•Frequency band of reception: 2405MHz to 2475MHz
•Receiving bandwidth: 20dB bandwidth: 2.8MHz

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Receiver for Wireless Hand Control, EG1A and Wireless Hand Control, EG1A include RF transmitters:
•Frequency band of transmission: 2405MHz to 2475MHz
•Type and frequency characteristics of the modulation: DSSS (direct sequence spread spectrum)/ QPSK
(offset quadrature phase shift keying)
•Effective radiated power: 4dBm
FCC Compliance Statement:
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
ETL Authorization Mark:
Technical Specifications for Devices Compliant with IEC-60601-1-2 4th Edition
The device complies with the following standards:
AAMI ES60601-1 Issued: 2006/03/09 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety
and Essential Performance, Amendment 1 –2012
CSA C22.2#60601-1 Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for
Basic Safety and Essential Performance
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 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) EN 60601-1:
2005 + A1:2013, IEC 60601-1 / EN 60601-1, Medical electrical equipment Part 1: General requirements for basic
safety and essential performance (CB Scheme)
IEC 60601-1-6:2010 (Third Edition) + A1:2013 for use in conjunction with IEC62366:2007 (First Edition) + A1:2014
and IEC 60601-1:2005 (Third Edition) + Corr.1 (2006) + Corr.2 (2007) + A1: 2012 or equivalent consolidated
version IEC 60601-1:2012 (Ad.3.1), Medical electrical equipment Part 1-6 General requirements for safety -
Collateral Standard: Usability
IEC 60601-1-2:2014 (Edition 4) Collateral Standard: Electromagnetic Compatibility- Medical Electrical Equipment.
.
Environmental Conditions
Wireless Hand Control, EG1A
(WIRELESS-HC)
Receiver for Wireless Hand Control,
EG1A (RECEIVER-HC)
Temperature
Operating: 18°-30°C (65°-85°F)
Operating: 18°-30°C (65°-85°F)
Transportation and Storage: -29° –+60°C
(-20° - +140°F)
Transportation and Storage: -29° –+60°C
(-20° - +140°F)
Relative Humidity
Operating: 30% to 70%
Operating: 30% to 70%
Transportation and Storage: 10% to 90%
Transportation and Storage: 50% to 90%

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Atmospheric
Pressure
Operating: 0.7–1.06bar
Operating: 0.7–1.06bar
Transportation and Storage:
Not applicable
Transportation and Storage:
Not applicable
Receiver for Wireless Hand Control, EG1A powered through Console
(SC3001/SC3002) Specifications
Primary: 100-240VAC, 50/60 Hz, 250 VA
Class I: Protective Earth
Wireless Hand Control, EG1A Specifications
Powered through: CR1620 lithium coin battery, nonreusable –disposable
Fluid Ingress Protection: IPX2
Guidance and manufacturer’s declaration –electromagnetic emissions
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.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The eG1 System uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The eG1 System is suitable for use in all establishments other
than domestic 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 fluctuations /
flicker emissions
IEC 61000-3-3
Complies
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
Electrostatic discharge
(ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for AC lines
1 kV for I/O lines
100kHz Pulse Repetition
Frequency
2 kV for AC lines
1 kV for I/O lines
100kHz Pulse Repetition
Frequency
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
0.5, 1kV line to line
0.5, 1, 2 kV line to earth
0.5, 1kV line to line
0.5, 1, 2 kV line to earth
Mains power quality should be
that of a typical commercial or
hospital environment.

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Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
0% UT (100% dip in UT) for
0.5 periods) at 0, 45,
90,135, 180, 225, 270,
315
0% UT (100% dip in UT) for
1 period)
70% UT (30% dip in UT) for
25 periods (50Hz) 30
periods (60Hz)
Interruptions 0% UT
(100% dip in UT) for 250
periods (50Hz) 320 periods
(60Hz)
0% UT (100% dip in UT) for 0.5
periods) at 0, 45, 90,135, 180,
225, 270, 315
0% UT (100% dip in UT) for 1
period)
70% UT (30% dip in UT) for 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 of the eG1 System
requires continued operation
during power mains
interruptions, it is recommended
that the eG1 System be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A / m
30 A / m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the A.C. mains voltage prior to application of the test level.

Page 14 of 17
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
Pd 2.1=
Pd 2.1=
80 MHz to 800 MHz
Pd 3.2=
800 MHz to 2,5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey, ashould 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.
aField 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.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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eG1 System Enclosure Port Immunity to RF Wireless Communications Equipment (IEC 61000-4-3)
Test
Frequency
(MHz)
Band a)
(MHz)
Service a)
Modulation b)
Maximum
Power
(W)
Distance
(m)
Immunity
Test Level
(V/m)
385
380 –390
TETRA 400
Pulse
modulation b)
18 Hz
1,8
0,3
27
450
430 –470
GMRS 460,
FRS460
FM c)
± 5 kHz deviation
1 kHz sine
2
0,3
28
710
704 –787
LTE Band
13,17
Pulse
modulation b)
217HZ
0,2
0,3
9
745
780
810
800 –960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
2
0,3
28
870
930
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 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 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
5 500
5 785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the
eG1 System may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.

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Recommended separation distances
between portable and mobile RF communications equipment and the eG1 System
The eG1 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the eG1 System can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the eG1 System as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Pd 2.1=
Pd 2.1=
Pd 3.2=
0,01
0.12
0.12
0.23
0,1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated 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 80 MHz and 800 MHz, the separation distance for 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.
Customer Service
Contact your local Depuy Synthes representative for Troubleshooting assistance.
To request a paper copy of the IFU call 800-255-2500.
Disposal of Waste
Dispose of items contaminated with body fluids or with other biohazardous waste. Please send devices that are no
longer used to your local DePuy Synthes representative. Devices must be disposed of as a healthcare medical
device in accordance with hospital procedures. The device contains electronics/battery and should be disposed off
in accordance to local and/or national regulations.
The Anspach Effort, Inc
4500 Riverside Drive
Palm Beach Gardens, FL 33410 USA
Tel: [phone]
www.e-IFU.com
US / 800-255-2500

Page 17 of 17
Not all products are currently available in all markets. Data available on request.
Please contact your 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.com
Pat. www.jnjmedicaldevices.com/en-US/patentmarking
© DePuy Synthes 2021. All rights reserved.
0000314957, A.5, 01/ 2022