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TM
ANSPACH™ EG1
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
SC3001
RECEIVER-HC
WIRELESS-HC
Consoles
Handpiece
SC3002
EG1A
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Summary of Contents for Synthes ANSPACH EG1
- Page 1 ANSPACH™ EG1 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.
- Page 2 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.
- Page 3 Non-ionizing electromagnetic radiation. (IEC 60417-5140) Transmitter Interference may occur CAUTION (Ref. 5.4.4 ISO 15223-1) in the vicinity of equipment marked with this symbol. Non-Sterile Made in Ref. 5.2.7 ISO 15223-1 Single sterile barrier system Packaging Unit - Indicates the number with protective of pieces in the package (ISO 7000- packaging inside (Ref.
- Page 4 Do not push receiver connector into console • Do not use accessories other than those connector port when out of alignment. 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.
- Page 5 Visually inspect for damage or cracks to the housing. Visually SC3001 inspect for damage to the electrical power cord. Power the system and inspect for illumination of the LEDs. If there is an SC3002 irrigation pump present, check for proper function. 2.
- Page 6 Figure 3: Push button on the receiver Figure 4: Push button on the hand control 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.
- Page 7 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.
- Page 8 The blue light indicator will “blink” Pairing with a slow flash during parring. The blue light indicator will be solid Paired blue. The blue light indicator will “blink” with a fast flash when device is out Out of Range of range, or the signal is lost due to interference.
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Page 9: Troubleshooting
The Battery indicator will start Hand Control Battery is at <25% flashing red. Capacity 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 • •... -
Page 10: Technical Specifications
• Ensure console in plugged in and repeat “pairing instructions” found on • Loss of Power Console power failure set up section. Technical Specifications FCC ID: WIRELESS-HC: 2AYUW-WHC1 RECEIVER-HC: 2AYUW-RHC1 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. - Page 11 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) •...
- Page 12 Operating: 0.7–1.06bar Operating: 0.7–1.06bar Atmospheric Transportation and Storage: Transportation and Storage: Pressure Not applicable 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 –...
- Page 13 Voltage dips, short 0% UT (100% dip in UT) for Mains power quality should be 0% UT (100% dip in UT) for 0.5 interruptions and that of a typical commercial or 0.5 periods) at 0, 45, periods) at 0, 45, 90,135, 180, voltage variations on hospital environment.
- Page 14 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. Electromagnetic environment – guidance Immunity test IEC 60601 test level Compliance level...
- Page 15 eG1 System Enclosure Port Immunity to RF Wireless Communications Equipment (IEC 61000-4-3) Test Maximum Immunity Band a) Distance Frequency Service a) Modulation b) Power Test Level (MHz) (MHz) (V/m) Pulse modulation b) 380 –390 TETRA 400 18 Hz FM c) GMRS 460, ±...
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Page 16: Disposal Of Waste
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. - Page 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...
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