Hologic Brevera 100 System Bedienungsanleitung Seite 7

Product Complaints and Technical Support
Report any complaints or problems in the quality, reliability, safety, or performance of this product to Hologic. If the device has caused or added to patient
injury, immediately report the incident to Hologic Authorized Representative and Competent authority of the respective member state or country. The
Competent Authorities, for medical devices, are usually the individual Member States' Ministry of Health, or an agency within the Ministry of Health.
For technical support or reorder information in the United States, please contact:
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Phone: 1-877-371-4372
www.hologic.com
International customers, contact your distributor or local Hologic Sales Representative:
Hologic BV
Da Vincilaan 5
1930 Zaventem
Belgium
Tel: +32 2 711 46 80
Troubleshooting
Refer to the Brevera User Guide for complete troubleshooting information.
AU SPONSOR
Hologic (Australia and New Zealand) Pty Ltd
Suite 302, Level 3
2 Lyon Park Road
Macquarie Park NSW 2113
Tel: 02 9888 8000
Symbols Used on Labeling
The following symbols may be found on the product labeling for the Brevera biopsy needle:
Symbol
Translations in Box
www.hologic.com/package-inserts
Description
Prescription use only
Authorized Representative in the European Community
CE Mark with notified body reference number
Translations in Box
Consult instructions for use
Follow instrctions for use
Do not use if package is damaged
Catalog number
Batch code
Quantity
5
Standard
21 CFR 801.109
ISO 15223-1, Reference 5.1.2
MDR Regulation (EU) 2017/745
Hologic
ISO 15223-1, Reference 5.4.3
IEC 60601-1, Reference No. Table D.2,
Safety sign 10 (ISO 7010-M002)
ISO 15223-1, Reference 5.2.8
ISO 15223-1, Reference 5.1.6
ISO 15223-1, Reference 5.1.5
Hologic
English