Cochlear Baha BI300 Bedienungsanleitung

Cochlear™Baha®Attract System

Radiographer’sInstructionsforMRI

The Cochlear™Baha®Attract System is a magnetic bone conduction implant system. The system includes an

osseointegrated BI300 Implant and a BIM400 Implant magnet that are implanted beneath the skin. A Baha Sound

Processor and a Sound Processor (SP) Magnet are worn on the head (see Fig. 1).

These guidelines are intended for radiologists performing MRI scans on a patient with the Cochlear Baha Attract

System. Please read this information carefully. For more information, contact Cochlear.

MRI Safety Information

The sound processor and Sound Processor Magnet must

be removed before entering a room where an MRI scanner

is located.

Non-clinical testing has demonstrated that the

BIM400 Implant Magnet, in combination with

a BI300 Implant, is MR Conditional.

It can be scanned safely under the following conditions.

Scanning under other conditions may result in severe

patient injury or device malfunction.

• Static magnetic ﬁeld of 1.5 Tesla only

• Maximum spatial gradient ﬁeld of 26600 Gauss/cm

(266 T/m)

• Maximum switched gradient slew rate per axis

of 200 mT/m/ms

• Maximum switched gradient amplitude per axis

of 45 mT/m

• Maximum MR System reported whole body averaged

speciﬁc absorption rate (SAR) of 2.0 W/kg

(Normal Operating Mode)

Additional instructions essential to safe use

in the MR environment:

Under the scan conditions deﬁned above, the

BIM400 Implant Magnet is expected to produce a

maximum temperature rise of 2.1 °C after 15 minutes

of continuous scanning.

In non-clinical testing, the BIM400 Implant

Magnet produced a temperature rise of less than

2.1 °C (extrapolated) at a maximum whole body

averaged speciﬁc absorption rate (SAR) of 2.0 W/kg

(extrapolated) assessed by calorimetry for 15 minutes

of MR scanning in a 1.5 Tesla Intera, Philips Medical

Systems (Software: 12.6.1.3, 2010-12-02) MR Scanner.

Figure 2

BI300 Implant

BIM400 Implant Magnet

Sound Processor Magnet

Baha Sound Processor

Figure 1

BUN264 ISS2 APR15

Cochlear Americas

13059 East Peakview Avenue

Centennial, CO 80111 USA

Telephone: 1 303 790 9010

Support: 1 800 483 3123

Cochlear Canada Inc.

2500-120 Adelaide Street West

Toronto, ON M5H 1T1 Canada

Telephone: 1 416 972 5082

Fax: 1 416 972 5083

www.Cochlear.com/US

trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names

of actual companies and products mentioned herein may be the trademarks of their respective owners.

Not everyone with hearing loss is a candidate for a Baha System. All surgical procedures

include an element of risk, and it is impossible to guarantee success. For complete

information regarding the risks and beneﬁts of a Baha procedure, please refer to the

Instructions for use for the Baha implant available at www.Cochlear.com/US/BahaIndications

In non-clinical gradient-induced heating testing, the

BIM400 Implant Magnet produced a temperature rise

(extrapolated) of less than 4.5 °C at a time rate of

change of the theoretical maximum worst-case gradient

magnetic ﬁeld dB/dt (extrapolated) of 200 T/s during 30

min. of continuous exposure in a test laboratory system

(Pulsed Magnetic Field Generator) equivalent with a

gradient system of a 1.5 Tesla MR system.

In non-clinical testing with the implant magnet in

place, the image artefact caused by the device extends

approximately 11.5 cm (4.5 in.) from the BIM400

Implant Magnet when imaged with a gradient echo

pulse sequence and a 1.5 Tesla MRI system (see Fig. 2)

NOTE: MR System manufacturers may claim that

scanning patients with implanted devices is generally

contraindicated. This is a general precautionary claim

due to the fact that MR System manufacturers are

unable to ensure safety for all types of implantable

devices. Cochlear has performed speciﬁc testing for

the above implants and established the necessary

SAR safety limits as outlined. Recently available MR

Systems are able to monitor SAR levels. The MR System

manufacturer should be able to provide advice on how

to maintain SAR levels with their system.

Dieses Handbuch passt für folgende Modelle

Inhaltsverzeichnis

Andere Cochlear Hörgerät Handbücher

Cochlear

Cochlear Baha BP100 Bedienungsanleitung

Cochlear

Cochlear Baha Softband Bedienungsanleitung

Cochlear

Cochlear Baha 5 SuperPower Bedienungsanleitung

Cochlear

Cochlear Baha Bedienungsanleitung

Cochlear

Cochlear nucleus 7 hybrid Bedienungsanleitung

Cochlear

Cochlear Baha Attract System Bedienungsanleitung

Cochlear

Cochlear Baha 6 Max Bedienungsanleitung

Cochlear

Cochlear Baha BP100 Bedienungsanleitung

Cochlear

Cochlear Baha 5 Wireless Phone Clip Bedienungsanleitung

Cochlear

Cochlear Baha Attract System Bedienungsanleitung

Cochlear

Cochlear Nucleus Freedom Bedienungsanleitung

Cochlear

Cochlear True Wireless Mini Microphone 2 Bedienungsanleitung

Cochlear

Cochlear Baha Attract System Bedienungsanleitung

Cochlear

Cochlear baha Classic 300 Bedienungsanleitung

Cochlear

Cochlear Nucleus 7 CP1000 Bedienungsanleitung

Cochlear

Cochlear Nucleus 7 Aqua+ Bedienungsanleitung

Cochlear

Cochlear Nucleus 6 Bedienungsanleitung

Cochlear

Cochlear Baha Attract System Bedienungsanleitung

Cochlear

Cochlear Baha Bedienungsanleitung

Cochlear

Cochlear Nucleus 7 Bedienungsanleitung

Cochlear

Cochlear Baha ZONE 5 Bedienungsanleitung

Cochlear

Cochlear Baha Attract System Bedienungsanleitung

Cochlear

Cochlear Kanso Bedienungsanleitung

Cochlear

Cochlear Baha Bedienungsanleitung

Beliebte Hörgerät Handbücher anderer Marken

Sonic

Sonic Bliss miniBTE Bedienungsanleitung

Lexie

Lexie B1 Stücklistenhandbuch

Widex

Widex FM+DEX Bedienungsanleitung

Siemens

Siemens Triano Bedienungsanleitung

Camplicomms

Camplicomms HC-200 Bedienungsanleitung

Widex

Widex SUPER 220 S2-VSD Bedienungsanleitung

Phonak

Phonak Q90 Bedienungsanleitung

Williams Sound

Williams Sound SoundPlus WIR 237 Leitfaden

Oticon Medical

Oticon Medical Ponto SoundConnector Bedienungsanleitung

Siemens

Siemens Life micon Bedienungsanleitung

Starkey

Starkey Destiny Bedienungsanleitung

Audicus

Audicus The Icon Bedienungsanleitung

Advanced Bionics

Advanced Bionics Slim HP Standard Bedienungsanleitung

Widex

Widex DREAM440 THE DREAM SERIES Bedienungsanleitung

Phonak

Phonak myPilot Bedienungsanleitung

NIKEN

NIKEN NK-401 Bedienungsanleitung

ON Semiconductor

ON Semiconductor Ezairo 7111 Pre Suite Bedienungsanleitung

Sonetik

Sonetik GOHEAR Bedienungsanleitung