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MANUAL | Users Manual | 638.59 KiB | February 16 2022 / August 15 2022 | delayed release | ||
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INTERNAL PHOTOS | Internal Photos | 1.03 MiB | February 16 2022 / August 15 2022 | delayed release | ||
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EXTERNAL PHOTOS | External Photos | 252.95 KiB | February 16 2022 | |||
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LABEL AND LOCATION | ID Label/Location Info | 369.28 KiB | February 16 2022 | |||
1 | BLOCK DIAGRAM | Block Diagram | February 16 2022 | confidential | ||||
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CONFIDENTIALITY REQUEST | Cover Letter(s) | 123.22 KiB | February 16 2022 | |||
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LETTER OF AGENCY | Cover Letter(s) | 114.58 KiB | February 16 2022 | |||
1 | OPERATIONAL DESCRIPTION | Operational Description | February 16 2022 | confidential | ||||
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1 | SCHEMATICS | Schematics | February 16 2022 | confidential | ||||
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TEST REPORT | Test Report | 4.22 MiB | February 16 2022 | |||
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TEST SETUP PHOTOS | Test Setup Photos | 5.53 MiB | February 16 2022 |
1 | MANUAL | Users Manual | 638.59 KiB | February 16 2022 / August 15 2022 | delayed release |
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 Page 1 of 17 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. 2. Clean receiver by wiping with non-abrasive cloth and neutral pH detergent and deionized, distilled, or purified Warning: Do not immerse or sterilize the receiver. 1. Disconnect receiver from console. 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 Consult Instructions for Use
(Ref. 5.4.3 ISO 15223-1) 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) Product is ETL listed to the requirements of US and Canada Locked Unlocked Reference or Catalogue Number
(Ref. 5.1.6 ISO 15223-1) Materials Date of Manufacture Manufacturer (Ref. 5.1.1 and 5.1.3 ISO15223-1) Keep dry (Ref. 5.3.4 ISO 15223-1) Do not use if package is damaged.
(Ref. 5.2.8 ISO 15223-1) Page 2 of 17 Warnings Non-ionizing electromagnetic radiation. (IEC 60417-5140) Transmitter Interference may occur in the vicinity of equipment marked with this symbol. Non-Sterile Ref. 5.2.7 ISO 15223-1 Single sterile barrier system with protective packaging inside (Ref. 5.2.13 ISO 15223-1) CAUTION (Ref. 5.4.4 ISO 15223-1) Made in 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) 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 UnsafeNot 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 Page 3 of 17 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. United States Federal law restricts this Use care to protect when handling, cleaning, and during system use. Do not push receiver connector into console connector port when out of alignment. Precautions 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. 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. Page 4 of 17 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. 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. SC3001 SC3002 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. Page 5 of 17 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. Page 6 of 17 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 Improper function, including but not limited to inability to connect to console or failure to pair. wear. Excessive temperature during operation. 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 patients 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. Page 7 of 17 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. Page 8 of 17 Trouble Shooting Wireless Hand Control, EG1A (WIRELESS-HC) Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Problem Receiver LED does not turn on when plugged into Console. Receiver not fully inserted Console not powered 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 Paired, but does not actuate 1.EG1 Handpiece is unlocked
(load) position Interference Device becomes unpaired Lost connection due to possible RF interference Battery failure Hand Control Battery is at <25%
Capacity The Battery indicator will start flashing red. Trouble Shooting Chart Possible Cause Possible Solution(s) Ensure receiver is fully inserted in foot pedal connector Ensure Console is Power ON 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) Ensure EG1 handpiece is in locked Move equipment away from source of
(run) position interference 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 Page 9 of 17 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 Page 10 of 17 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. Temperature Relative Humidity Environmental Conditions Wireless Hand Control, EG1A
(WIRELESS-HC) Operating: 18-30C (65-85F) Transportation and Storage: -29 +60C
(-20 - +140F) Operating: 30% to 70%
Transportation and Storage: 10% to 90%
Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Operating: 18-30C (65-85F) Transportation and Storage: -29 +60C
(-20 - +140F) Operating: 30% to 70%
Transportation and Storage: 50% to 90%
Page 11 of 17 Atmospheric Pressure Operating: 0.71.06bar Transportation and Storage:
Not applicable Operating: 0.71.06bar 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 manufacturers 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 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /
flicker emissions IEC 61000-3-3 Group 1 Class A Class A Complies 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. 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. Guidance and manufacturers 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 Electrostatic discharge
(ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 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 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 Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Page 12 of 17 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 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) *
30 A / m 30 A / m 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 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 13 of 17 Guidance and manufacturers 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 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) 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 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 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. Page 14 of 17 Pd2.1=Pd2.1=Pd3.2=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 400 450 430 470 GMRS 460, FRS460 704 787 LTE Band 13,17 800 960 1 700 1 990 2 400 2 570 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 710 745 780 810 870 930 1 720 1 845 1 970 2 450 5 240 5 500 5 785 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Pulse modulation b) 217HZ Pulse modulation b) 18Hz Pulse modulation b) 217 Hz Pulse Modulation b) 217 Hz Pulse modulation b) 217 Hz 1,8 2 0,2 2 2 2 0,3 0,3 0,3 0,3 0,3 0,3 28 27 28 9 28 28 9 5 100 5 800 WLAN 802.11 a/n 0,2 0,3 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. Page 15 of 17 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 0,01 0,1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 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. www.e-IFU.com US / 800-255-2500 The Anspach Effort, Inc 4500 Riverside Drive Palm Beach Gardens, FL 33410 USA Tel: (800) 327 6887 / +1 561 627 1080 Page 16 of 17 Pd2.1=Pd2.1=Pd3.2=
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 Page 17 of 17
1 | INTERNAL PHOTOS | Internal Photos | 1.03 MiB | February 16 2022 / August 15 2022 | delayed release |
1 | LABEL AND LOCATION | ID Label/Location Info | 369.28 KiB | February 16 2022 |
15 14 13 12 PROPRIETARY INFORMATION NOTICE IS HEREBY GIVEN THAT ALL DATA CONTAINED IN, REVEALED BY, OR SHOWN IN THIS DOCUMENT IS PROPRIETARY AND BELONGS TO THE ANSPACH EFFORT. IT IS FURNISHED AND RECEIVED IN CONFIDENCE SOLELY FOR INFORMATIONAL PURPOSES OF THE RECIPIENT FOR THE PURPOSES HEREWITH TRANSMITTED. NONE OF THE INFORMATION CONTAINED HEREIN SHALL BE USED FOR ANY OTHER PURPOSES OR DUPLICATED IN WHOLE OR IN PART WITHOUT PRIOR AUTHORIZATION OF THE ANSPACH EFFORT INC. J 11 10 9 8 7 6 5 4 3 2 1 REVISIONS D01.03 CO REV. PBG-006443 PBG-100620 A B DESCRIPTION PRODUCTION RELEASE / DESIGN FREEZE. DIM .689/.679 WAS .685;
.739/.733 WAS
.739/.736. UPDATED MARKINGS ON SHEET 2. SHEET 2: DELETED NOTES 2.1, 2.4, 2.5. RENUMBERED NOTES. CHG 2.1 TO INK: SIGMA MP-320 WHITE EO. AND 2.2 TO HARDENER: MP-200; ADDED 2.3 THINNER: MP-102. DWN BY CO DATE 02/18/21 DC DC 6 B B 2.865.004 +DFT 3.055 -DFT 2.857
.000
.005 -DFT
2X
.012
.010
.037.001 DETAIL D SCALE 8 : 1
.680 -DFT
.630 +DFT
.140 4 D SECTION B-B NOTES:
1. UNLESS OTHERWISE SPECIFIED, ALL SURFACES ARE DEFINED DIRECTLY FROM 3D CAD MODEL FILE 44-3045(X).STEP. (X = CURRENT REV) 3D CAD MODEL IS CONTROLLING DOCUMENT. DRAWING PROVIDES ADDITIONAL INFORMATION FOR TOOL BUILD, PRODUCTION AND INSPECTION OF PART. ALL PART DIMENSIONS QUERIED FROM 3D CAD MODEL ARE NOMINAL AND SHALL CONFORM TO TOLERANCES INDICATED IN TABLE BELOW:
VALUES IN INCHES ABOVE
.000
.250 1.500 UP TO, INCLUDING
.250 1.500 3.250 TOLERANCE
.002
.004
.005 2. MATERIAL: PC RESIN, MAKROLON 2458 2.1 USE OF REGRIND MATERIAL IS NOT ACCEPTABLE. 2.2 SUPPLIER TO PROVIDE MATERIAL CERTIFICATE OF CONFORMANCE OR ANALYSIS WITH EACH SHIPMENT. 3. COLOR: PANTONE BLACK M H G F E D C B A 5. EJECTOR, GATE, PARTING LINE, AND OTHER FEATURES FOR TOOLING CONSIDERATIONS ARE SUBJECT TO APPROVAL BY ANSPACH BEFORE TOOL CONSTRUCTION. 6. GATE REMNANT TO BE FLUSH OR BELOW SURFACES NOTED. 7. FLASH AND PARTING LINE MISMATCH NOT TO EXCEED .005 . MATERIAL 8. MOLD RELEASE NOT PERMITTED AND PART MUST BE FREE OF OTHER SURFACE CONTAMINANTS. SEE NOTES UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES AND INCLUDE APPLIED FINISH TOLERANCES DESIGN ORIG CHECKED BY O. NEICONI 9. AFTER TOOL CONSTRUCTION, SUPPLIER MUST COMPLETE A FIRST ARTICLE INSPECTION REPORT AND SUBMIT IT TO DEPUY SYNTHES ENGINEERING FOR TOOL AND PART APPROVAL. FINISH SEE NOTES UNLESS OTHERWISE SPECIFIED TOLERANCES ARE:
LINEAR .XX
.01
.XXX
.005
.XXXX
.0005 ANGLES 1 1/64 FRACTIONS DESIGN ENGR MFG ENGR 4. WHERE NOTED, MOLD TEXTURE EXTERIOR SURFACES WITH MT11020 OR EQUIVALENT. 10. PRODUCT AND PROCESSES SHALL BE RoHS COMPLIANT 15 14 13 12 11 10 9 8 7 6 5 4
.689
.679 SECTION A-A EJECTOR PIN MARKS PERMISSIBLE ANSPACH 4500 RIVERSIDE DRIVE, PALM BEACH GARDENS, FL 33410 TITLE DWG NO HOUSING, BOTTOM, HAND CONTROL 44-3045 SCALE FILE NAME 2:1 3 44-3045(B) 2 1 REV B SHEET A 1 OF 2 SCALE 1:1
.832
.025 +DFT A A
.026.002
.031.001
.739
.733 2X .630 4
.658 4 4 J H G F E D C B DDC RELEASED 07/22/21 15 14 13 12 PROPRIETARY INFORMATION NOTICE IS HEREBY GIVEN THAT ALL DATA CONTAINED IN, REVEALED BY, OR SHOWN IN THIS DOCUMENT IS PROPRIETARY AND BELONGS TO THE ANSPACH EFFORT. IT IS FURNISHED AND RECEIVED IN CONFIDENCE SOLELY FOR INFORMATIONAL PURPOSES OF THE RECIPIENT FOR THE PURPOSES HEREWITH TRANSMITTED. NONE OF THE INFORMATION CONTAINED HEREIN SHALL BE USED FOR ANY OTHER PURPOSES OR DUPLICATED IN WHOLE OR IN PART WITHOUT PRIOR AUTHORIZATION OF THE ANSPACH EFFORT INC. J 11 10 9 8 7 6 5 4 3 2 1 D01.03 H G F E D C B A NOTES:
1. PART MARKING:
1.1 PAD PRINT, SEE NOTE 2 1.2 COLOR: WHITE, SOLID FILLED, AS SHOWN 1.3 ANSPACH SHALL SUPPLY GRAPHICS FILES. 2. PAD PRINTING:
2.1 INK: SIGMA MP-320 WHITE EO 2.2 HARDENER: MP-200 2.3 THINNER: MP-102 TEXT SHALL BE IN ARIAL FONT. 3. FORMAT (NOT ACTUAL NUMBER) AND HEIGHT:
3.1 WIRELESS-HC ; .06 MIN HIGH 3.2 FCC ID: ; .05 MIN HIGH 3.3 IC: ; .05 MIN HIGH 4. DIMENSIONS ARE FOR MANUFACTURING REFERENCE ONLY AND ARE NOT INTENDED FOR INSPECTION. MARKING FILES ITEM NO DESCRIPTION SPEC GRAPHIC FILE GRAPHIC HEIGHT 5. 6. 7. 8. CE 2797 MARK 17-0439 17-0426 17-0441 NON-IONIZING RADIATION 17-0448 17-0448 CATALOG NUMBER SYMBOL 17-0395 17-0395 CROSSED OUT WHEELED BIN SYMBOL 17-0394 17-0394
.20
.09
.20
.18
.22 THIS AREA RESERVED FOR FCC ID AND CANADA IC NUMBERS 5 8 6 3 7 3
.13
.82 1.03 1.18 2.13 4X EJECTOR PIN MARKS PERMISSIBLE 15 14 13 12 11 10 9 8 7 6 5 4 3 DWG NO 44-3045 SCALE 3:1 FILE NAME 44-3045(B) 2 REV B SHEET 2 OF 2 1 J H G F E D C B A
1 | CONFIDENTIALITY REQUEST | Cover Letter(s) | 123.22 KiB | February 16 2022 |
02/02/2022 Attention: Application Examiner RE:
Request for Confidentiality Applicant: DepuySynthes Power Tools FCC ID: 2AYUW-WHC1 To Whom It May Concern:
Short-term Confidentiality Request is hereby submitted by DepuySynthes Power Tools to withhold from public review for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing, certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept confidential for a period of 180 days from the date of Authorization:
User manual Internal photos Permanent Confidentiality Request is hereby submitted by DepuySynthes Power Tools to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:
Schematics Detailed Operational/Functional Description Block Diagram Rationale for request for confidentiality:
DePuy Synthes Power Tools has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, 1(1)
1 | LETTER OF AGENCY | Cover Letter(s) | 114.58 KiB | February 16 2022 |
Limited Agency Agreement DepuySynthes Power Tools FCC ID: 2AYUW-WHC1 01/06/2022 Federal Communications Commission 445 12th Street SW Washington, DC 20554 Subject:
To Whom It May Concern:
We, DepuySynthes Power Tools, hereby authorized Intertek Testing Services to act as our Agent for the purpose of preparing application for FCC ID number 2AYUW-WHC1 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 01/06/2022. The Limited Agency Agreement expires on 01/06/2023, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely,
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-02-16 | 2405 ~ 2475 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-02-16
|
||||
1 | Applicant's complete, legal business name |
DePuySynthes Power Tools
|
||||
1 | FCC Registration Number (FRN) |
0030512123
|
||||
1 | Physical Address |
4500 Riverside Dr.
|
||||
1 |
Palm Beach Gardens, FL
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@intertek.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AYUW
|
||||
1 | Equipment Product Code |
WHC1
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
P****** R********
|
||||
1 | Telephone Number |
+1561********
|
||||
1 | Fax Number |
561-6********
|
||||
1 |
P******@ITS.JNJ.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/15/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | EG1 Wireless Hand Control System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is Peak conducted. This device is a mobile device with respect to RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek Testing Services NA Inc.
|
||||
1 | Name |
Y****** L********
|
||||
1 | Telephone Number |
978 6********
|
||||
1 |
y******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2405.00000000 | 2475.00000000 | 0.0029110 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC