DePuy Synthes
ANSPACHTM EG1TM WIRELESS HAND CONTROL SYSTEM
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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 •
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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)
Manufacturer and Date of Manufacture (Ref. 5.1.1 ISO 15223-1)
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
Caution (Ref. 5.4.4 ISO 15223-1)
Non-ionizing electromagnetic radiation. (IEC 60417-5140) Transmitter Interference may occur in the vicinity of equipment marked with this symbol.
Made in
Non-Sterile (Ref. 5.2.7 ISO 15223-1)
Packaging Unit - Indicates the number of pieces in the package (ISO 7000-2794)
Single sterile barrier system with protective packaging inside (Ref. 5.2.13 ISO 152231)
Unique Device Identifier
Sterilized using ethylene oxide (Ref. 5.2.3 ISO 15223-1)
Lot or Batch Number (Ref. 5.1.5 ISO 15223-1)
Use-by Date (Ref. 5.1.4 ISO 15223-1)
Humidity Limitation (Ref. 5.3.8 ISO 15223-1)
Temperature Limit (Ref. 5.3.7 ISO 15223-1)
Do not re-use (Ref. 5.4.2 ISO 15223-1)
Ingress protection rating according IEC 60529
Follow instructions for use (ISO 7010-M002)
Date of Manufacture (Ref. 5.1.3 ISO 15223-1)
FCC Symbol
Page 2 of 14 • EG1™ WIRELESS HAND CONTROL SYSTEM
DePuy Synthes
Warnings • Qualified healthcare professionals are responsible for learning proper techniques in use of equipment; improper use may cause serious injury to user or patient or damage to system.
• 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 Instruction for Use.
• Instrument operator and all operating room personnel must wear eye protection.
• 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.
• 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.). • 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 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. • 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.
NOTE: “Harmful interference” is defined by the FCC as follows: Interference that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs, or repeatedly interrupts a radio communication service operating in accordance with FCC rules. • 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 High Speed 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.
• 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. • Not for use in Magnetic Resonance Imaging (MRI) environments. DePuy Synthes
EG1™ WIRELESS HAND CONTROL SYSTEM •
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Wireless Hand Control Set Up
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.
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.
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.
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. 3. Remove the Wireless Hand Control, EG1A from packaging, slide safety cover to the unlock position (See Figure 2), grab the battery pull tab and remove it by pulling in the direction indicated. Attach the hand control onto the EG1A handpiece. See Figure 3. ▲ Warning: Keep hand control safety cover in locked position when not in use.
Figure 1: Receiver connects to the foot control connector port on console (SC3001 or SC3002)
Figure 2: Hand control cover shown in unlocked position
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EG1™ WIRELESS HAND CONTROL SYSTEM
DePuy Synthes
4. Pair Handpiece. Press and release the button on the receiver (See Figure 4). Press the hand control button (See Figure 5) 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. 5. Start operation: Press button on the hand control to start handpiece (See Figure 5). Increase pressure on button to increase speed of handpiece and release pressure on button to decrease speed of handpiece.
Figure 3: Attach hand control onto the eG1A handpiece
▲ Warning: Keep hand control safety cover in locked position when not in use. 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.
Figure 4: Push button on the receiver
Figure 5: Push button on the hand control
DePuy Synthes
EG1™ WIRELESS HAND CONTROL SYSTEM •
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End of Life Wireless Hand Control, EG1A (WIRELESS-HC)
Display
Result
Description
Not Paired
Press the button on the receiver and wait until light flashes blue to initiate pairing.
Pairing
The blue LED indicator will flash slowly during pairing.
Paired
The blue LED indicator will be solid blue.
Pairing Interrupted
The blue LED indicator will flash quickly when device is out of range, or the signal is lost due to interference.
Hand Control Battery is at FULL Capacity
The red LED battery indicator will be OFF.
Hand Control Battery is at <50% Capacity
The red LED battery indicator will be solid red.
Hand Control Battery is at <25% Capacity
The Battery indicator will start flashing red.
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-JakobDisease (TSE/CJD) diagnosis, DePuySynthes 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. Page 6 of 14 •
EG1™ WIRELESS HAND CONTROL SYSTEM
DePuy Synthes
Trouble Shooting Wireless Hand Control, EG1A (WIRELESS-HC) Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Trouble Shooting Chart Problem Receiver LED does not turn on when plugged into console
Cannot pair the device
Possible Cause(s) •
Receiver not fully inserted
•
Console not powered ON
•
Battery tab not removed • from hand control • RF interference Hand control battery is depleted Hand control was previously paired with another receiver
• • •
Paired, but does not actuate
Device becomes unpaired
Possible Solution(s)
•
eG1 handpiece is unlocked (load) position
•
Interference
•
Lost connection due to possible RF interference
•
Battery failure
•
Ensure receiver is fully inserted in foot pedal connector
•
Ensure console is powered ON
DePuy Synthes
•
Console power failure
Repeat “Pairing Instructions” found in set up section or maintain a minimum distance between portable-mobile RF communications equipment (transmitters) and the eG1 High Speed System as per Recommended separation distances between portable and mobile RF communications equipment and the eG1 High Speed System table
•
Discard and replace receiver
•
Discard and replace hand control (can only be paired with one receiver)
•
Ensure eG1 handpiece is in locked (run) position Move equipment away from cause of interference
• •
• Loss of power
Ensure battery pull tab is removed
•
Maintain a minimum distance between portable-mobile RF communications equipment (transmitters) and the eG1 High Speed System as recommended in the Recommended separation distances between portable and mobile RF communications equipment and the eG1 High Speed System table Discard and replace hand control Ensure console is plugged in and repeat “pairing instructions” found in set up section.
EG1™ WIRELESS HAND CONTROL SYSTEM •
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Technical Specifications FCC ID WIRELESS-HC: 2AYUW-WHC1 RECEIVER-HC: 2AYUW-RHC1 The devices comply with the following standards: CFR47 FCC Part 15.247 Subpart C: 10/2021 Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz. All measurement performed in 10m chamber. CFR47 FCC Part 15 Subpart B: 10/2021 Unintentional Radiators RSS-247 Issue 2 February 2017 Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and License-Exempt Local Area Network (LELAN) Devices RSS-Gen Issue 5 April 2018 +Amendment 1 March 2019 General Requirements for Compliance of Radio Apparatus RSS-102 Issue 5 March 2015 Radio Frequency (Rf) Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands) ISED ICES-003 Issue 7, October 15 2020 Information Technology Equipment (Including Digital Apparatus) – Limits and Methods of Measurement 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
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: 2405 MHz to 2475 MHz • Receiving bandwidth: 20 dB bandwidth: 2.8 MHz
Receiver for Wireless Hand Control, EG1A and Wireless Hand Control, EG1A include RF transmitters • Frequency band of transmission: 2405 MHz to 2475 MHz • Type and frequency characteristics of the modulation: DSSS (direct sequence spread spectrum)/ QPSK (offset quadrature phase shift keying) • Effective radiated power: 4 dBm (0.0025 W)
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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. NOTE: “Harmful interference” is defined by the FCC as follows: Interference that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs, or repeatedly interrupts a radio communication service operating in accordance with FCC rules.
ETL Authorization Mark Technical Specifications for Devices Compliant with IEC 60601-1-2 4th Edition CONFORMS TO AAMI STD ES60601-1 IEC STD 60601-1-6 CERTIFIED TO CSA STD C22.2 # 60601-1
The device complies with the following standards: ANSI/AAMI ES60601-1 2005 / I2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance CAN/CSA C22.2 No. 60601-1:14, Third Edition Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 62311 Edition 1.0 (2007-08), CENELEC EN 62311:2008, Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz - 300 GHz) IEC 60601-1:2005+A1:2012, Third Edition Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-6:2010+A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. NOTE: The eG1 system is determined to have no Essential Performance or unacceptable risk to the patient or operator. DePuy Synthes
Environmental Conditions Wireless Hand Control, EG1A (WIRELESS-HC) Temperature
Relative Humidity
Atmospheric Pressure
Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
Operating: 18° to 30°C (65° to 85°F)
Operating: 18° to 30°C (65° to 85°F)
Transportation and Storage: -29° to +60°C (-20° to +140°F)
Transportation and Storage: -29° to +60°C (-20° to +140°F)
Operating: 5% to 70%
Operating: 5% to 70%
Transportation and Storage: 30% to 90%
Transportation and Storage: 50% to 90%
Operating: 0.7 to 1.06 bar
Operating: 0.7 to 1.06 bar
Transportation and Storage: Not applicable
Transportation and Storage: Not applicable
Receiver for Wireless Hand Control, EG1A powered through Console (SC3001/SC3002) Specifications Primary: 100-240 VAC, 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 High Speed System is intended for use in the electromagnetic environment specified below. The customer or the user of the eG1 High Speed 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 High Speed 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 B
The eG1 High Speed System is suitable for use in all establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3
Complies
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EG1™ WIRELESS HAND CONTROL SYSTEM •
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Guidance and Manufacturer’s Declaration –Electromagnetic Immunity The eG1 High Speed System is intended for use in the electromagnetic environment specified below. The customer or the user of the eG1 High Speed 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)
±8 kV contact
±8 kV contact
The relative humidity should be at least 5%.
±15 kV air
±15 kV air
±2 kV for AC lines ±1 kV for I/O lines 100 kHz Pulse Repetition Frequency
±2 kV for AC lines Mains power quality should be that of a typical ±1 kV for I/O lines commercial or hospital environment. 100 kHz Pulse Repetition Frequency
±0.5, 1 kV line to line ±0.5, 1, 2 kV line to earth
±0.5, 1 kV line to line Mains power quality should be that of a typical ±0.5, 1, 2 kV line to earth commercial or hospital environment.
0% UT (100% dip in UT) for 0.5 periods) at 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°
70% UT (30% dip in UT) for 25 periods (50 Hz) 30 periods (60 Hz)
Mains power quality should be that of a typical 0% UT (100% dip in UT) commercial or hospital environment. for 0.5 periods) at 0°, 45°, 90°, 135°, 180°, 225°, (*) If the user of the eG1 High Speed System 270°, 315° requires continued operation during power mains interruptions, it is recommended that 0% UT (100% dip in UT) the eG1 High Speed System be powered from for 1 period) an uninterruptible power supply or a battery. 70% UT (30% dip in UT) for 25 periods (50 Hz) 30 periods (60 Hz)
Interruptions 0% UT (100% dip in UT) for 250 periods (50 Hz) 320 periods (60 Hz)
Interruptions 0% UT (100% dip in UT) for 250 periods (50 Hz) 320 periods (60 Hz) *
30 A / m
30 A / m
IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
0% UT (100% dip in UT) for 1 period)
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8 ■ Note: UT is the A.C. mains voltage prior to application of the test level.
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EG1™ WIRELESS HAND CONTROL SYSTEM
DePuy Synthes
Guidance and Manufacturer’s Declaration –Electromagnetic Immunity The eG1 High Speed System is intended for use in the electromagnetic environment specified below. The customer or the user of the eG1 High Speed 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
3 Vrms 150 kHz to 80 MHz
6 Vrms in ISM bands 150 kHz to 80 MHz
6 Vrms in ISM bands 150 kHz to 80 MHz
Except as indicated in the table on page 12, portable and mobile RF communications equipment should be used no closer to any part of the eG1 High Speed System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.7 GHz
3 V/m 80 MHz to 2.7 GHz
80% at 1 kHz (AM modulation)
80% at 1 kHz (AM modulation)
80 MHz to 800 MHz 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 d is 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:
■ 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 High Speed System is used exceeds the applicable RF compliance level above, the eG1 High Speed 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 High Speed System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
DePuy Synthes
EG1™ WIRELESS HAND CONTROL SYSTEM •
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eG1 System Enclosure Port Immunity to RF Wireless Communications Equipment (IEC 61000-4-3) Services for which the recommended separation distance is 30 cm Test Frequency (MHz)
Band a) (MHz)
Service a)
Modulation
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
2
0.3
28
1 kHz sine 710
704 – 787
LTE Band 13,17
Pulse modulation b) 217 Hz
0.2
0.3
9
800 – 960
GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5
Pulse modulation b) 18 Hz
2
0.3
28
1700 – 1990
GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS
Pulse modulation b) 217 Hz
2
0.3
28
5100 – 5800
WLAN 802.11 a/n
Pulse modulation b) 217 Hz
0.2
0.3
9
745 780 810 870 930 1720 1845 1970
5240 5500 5785
■ Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the eG1 High Speed 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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EG1™ WIRELESS HAND CONTROL SYSTEM
DePuy Synthes
Recommended separation distances between portable and mobile RF communications equipment and the eG1 System The eG1 High Speed System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the eG1 High Speed System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the eG1 High Speed System as recommended below, according to the maximum output power of the communications equipment except as indicated in the table on page 12. 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
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
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 • The devices contain electronics/battery and must not be disposed of with household waste. • Dispose of items contaminated with body fluids with other biohazardous waste. • At end of life, recycle or dispose of device in an environmentally friendly manner and in accordance with local and national regulations. • All products returned to DePuy Synthes should be properly cleaned, disinfected and sterilized as applicable prior to shipping.
DePuy Synthes
EG1™ WIRELESS HAND CONTROL SYSTEM •
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www.e-IFU.com US / 800-255-2500 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 Pat. www.jnjmedtech.com/en-US/patentmarking
The Anspach Effort, Inc 4500 Riverside Drive Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887 / +1 561 627 1080
www.jnjmedtech.com © DePuy Synthes 2022. All rights reserved. WINDCHILL # 0000314957, A.19, 05/2022
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