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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 

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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