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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. 

Содержание ANSPACH EG1

Страница 1: ...d for cutting and shaping bone including the cranium and spine Contraindications The eG1 High Speed System does not have any known product specific contraindications Potential Adverse Events As with a...

Страница 2: ...ction causing delay in surgery The Hand Control is provided sterile Remove product from the package using established operating room procedures for sterile transfer Store sterile devices in their orig...

Страница 3: ...its packaging is compromised Visually inspect device components for damage before using do not use if damage or wear is evident unrecognizable markings missing or removed part numbers corrosion etc M...

Страница 4: ...rical Equipment Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the eG1 system Othe...

Страница 5: ...e field Caution Do not push receiver connector into console connector port when out of alignment Figure 1 Receiver connects to the foot control connector port on console SC3001 or SC3002 3 Remove the...

Страница 6: ...dpiece and release pressure on button to decrease speed of handpiece Warning Keep hand control safety cover in locked position when not in use Figure 5 Hand control cover shown in unlocked position 6...

Страница 7: ...st All Instrument System components returned should be properly cleaned as applicable prior to shipping to the manufacturer Warning Transmissible Spongiform Encephalopathies TSE DePuy Synthes Power To...

Страница 8: ...ator will be solid blue Out of Range The blue light indicator will blink with a fast flash when device is out of range or the signal is lost due to interference Hand Control Battery is at FULL Capacit...

Страница 9: ...ure device maintain a minimum distance between portable and mobile RF communications equipment transmitters and the eG1 System as recommended in the Recommended separation distances between portable a...

Страница 10: ...mmunication Apparatus All Frequency Bands Concurrently with FCC Part 15 247 IC ICES 003 2016Ed 6 Information Technology Equipment Including Digital Apparatus Limits and Methods of Measurement Concurre...

Страница 11: ...e IEC 60601 1 6 Issued 2013 10 29 Ed 3 Medical Electrical Equipment Part 1 6 General Requirements for Basic Safety and Essential Performance Collateral Standard Usability Amendment 1 IEC 60601 1 2005...

Страница 12: ...tic establishments and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluc...

Страница 13: ...r 25 periods 50Hz 30 periods 60Hz Interruptions 0 UT 100 dip in UT for 250 periods 50Hz 320 periods 60Hz Mains power quality should be that of a typical commercial or hospital environment If the user...

Страница 14: ...magnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3...

Страница 15: ...M 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse Modulation b 217 Hz 2 0 3 28 5 240 5 100 5 80...

Страница 16: ...stimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At...

Страница 17: ...DePuy Synthes Representative for more information All DePuy Synthes Implant Instructions for Use as well as general Instructions for Use are available as PDF files at www e ifu com www depuysynthes c...

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