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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 receiver 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. 

 
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 

 

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) 

 

 

Date of Manufacture   
 
Manufacturer (Ref. 5.1.1 and 5.1.3 
ISO15223-1) 

 

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 

 

 

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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