Safety Information - Codman ORBIT GALAXY G2 Información Importante

hoop, attach the new connecting cable. If the System Ready light is
now illuminated, the Microcoil Delivery System is functioning properly.
Re-package the malfunctioning Microcoil System, and return it to
Codman & Shurtleff or an authorized representative for replacement.
• If the System Ready light still does not illuminate, the DCB is NOT
functioning properly. The DCB should not be used and should be returned
to Codman & Shurtleff or an authorized representative for replacement.
5. Disconnect the cable connector from the DPU hub connector. The Microcoil
System and DCB are ready to be used.
6. Press the Power button again to turn off the DCB until it is ready to be used
in the procedure.
Note: The EnPOWER DCB has an automatic shut off after ½ hour of non-use.
If the DCB automatically shuts off, press the Power button to restart.
7. Refer back to the Microcoil Inspection and Placement Section of this IFU.

SAFETY INFORMATION:

The CODMAN Detachment Control Box (DCB000001-20 and DCB000005-00)
comply with the requirements of:
• ANSI/AAMI ES60601-1:2005
• CAN/CSA-C22.2 No. 60601-1:2008
• IEC 60601-1 (2005) 3rd Edition
• EN 60601-1 (2006) 3rd Edition
• IEC 60601-1-6 (2010)
• IEC 62366 (2007)
• IEC 60601-1-2 (2007)
Detachment Control Box Specifications
Blue EnPOWER Detachment Control Box,
Catalog Number DCB000005-00
• Battery type: lithium
• Input voltage: 3.6 VDC
• Output voltage: 9.0 VDC, maximum
• Output current: 200 mA, maximum
• Operating temperature:
18 to 35°C (65 to 95°F)
• Operating humidity: 0 to 85% RH,
non-condensing
• Transport & Storage Temperature:
-18°C to 60°C
• Transport & Storage Humidity:
10% to 85% RH non-condensing
• Transport & Storage Pressure:
500 hPa to 1050 hPa
• Operating Pressure Range:
700 hPa to 1060 hPa
• Electrical safety classification: Class
IIA Medical Product, internally
powered, Type CF, ordinary
equipment, intermittent operation
• Ingress of liquid classification:
IPX2 rating
Cleaning Instructions for the Detachment Control Box
The DCB may be cleaned by wiping its surface with 70% isopropyl alcohol, a mild
detergent, or disinfectant and a soft cloth. Use caution when cleaning near the
output connector.
Repair of Detachment Control Box
There are no user serviceable parts in the DCB. If the DCB is not functioning
properly it should not be used and should be returned to Codman & Shurtleff or an
authorized representative for replacement.
Storage Instructions for the Detachment Control Box
Between uses, the DCB should be stored in a clean environment that is protected
against extreme temperature and humidity.
Disposal of the Detachment Control Box
Do not discard this product as unsorted municipal waste. Contact your local
authorities for disposal instructions or return it to Codman & Shurtleff for disposal.
MAGNETIC RESONANCE IMAGING (MRI) INFORMATION
Non-clinical testing demonstrated that the detachable coil is MR Conditional. A patient with
this device can be scanned safely, immediately after implant, under the following conditions:
Static Magnetic Field
• static magnetic field of 3 Tesla or less
• maximum spatial gradient magnetic field of 720 Gauss/cm or less
MRI-RELATED HEATING
In non-clinical testing, the coil produced a temperature rise of +1.8 degrees centigrade during
MRI performed for 15 minutes of scanning in a 3 Tesla MR system. Therefore, the MRI-related
heating experiments for the detachable coil at 3 Tesla using a transmit/receive RF body coil
at an MR system reported whole-body-averaged specific absorption rate (SAR) of 2.9-W/kg
indicated that the greatest amount of heating that occurred in association with these specific
conditions was equal to or less than +1.8 degrees centigrade. MR image quality can be
compromised if the area of interest is in the same area or relatively close to the position of the
detachable coil. Optimization of MR imaging parameters is recommended.
WARRANTY
Codman & Shurtleff, Inc. warrants that this medical device is free from defects in both
materials and workmanship. Any other express or implied warranties, including warranties
of merchantability or fitness, are hereby disclaimed. Suitability for use of this medical
device for any particular surgical procedure should be determined by the user in
conformance with the manufacturer's instructions for use. There are no warranties that
extend beyond the description on the face hereof.
® ORBIT GALAXY, XTRASOFT, and EnPOWER are registered trademarks of Codman & Shurtleff, Inc.
SYMBOLS
Blue EnPOWER
DCB000005-00
Power on/off
Detach button
Detach cycle
Full battery power
Low battery power
Dead battery
System fault
System ready
Cardiac floating
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