Manual BI160-GE - NORAS MRI products GmbH

More documents

Recommendations

Info

6 2 Intended Purpose 2. Intended Purpose The BI160-GE is a medical device and is used to immobilize the female breast and for MR supported assistance for puncture, tissue removal and minimally invasive procedures. It may only be used by trained personnel in clinical situations. With the aid of the immobilization grid the breast is held fi rmly during the examination. The needle can be positioned and guided using the grid or a positioning system. Indication Tissue removal from medial and lateral direction. Contraindication Option Grid Option Positioning Device (Post&Pillar) All examinations are contraindicated that are contraindicated for MRI according to GE (e.g. breast implants, pace makers, surgical metal implants or similar). Furthermore in the event of unclear or critical symptoms, responsibility lies with the treating doctor. BI160-GE
3. Operating Principle Operating Principle The immobilization of the breast is done in the mamma coil in a mediolateral direction. After localization of the lesion (following a diagnostic examination), the coordinates obtained are transferred to the positioning unit or the grid. Safety Concept The following safety concept must be strictly followed while performing a biopsy. A control scan must be made after each work step to verify the correct completion of the previous work steps to be able to recognize incorrect adjustments of the needle guides bases and needle blocks during the biopsy. That is the only way incorrect adjustments, incorrectly read scale values and other operator errors can be recognized in order to prevent injuries of the patient. The control scan procedure is described in Chapter “Localization and Biopsy Process”, in the description of the biopsy procedure, and the correct result illustrated in the text. BI160-GE 3 7
Page 1 and 2: NORAS Immobilization and Biopsy Sys
Page 3 and 4: Contents 1. General Information ...
Page 5: 1. General Information General Info
Page 9 and 10: Rating Plates Compression Plate Ger
Page 11 and 12: 4.2.3 Combination with other Device
Page 13 and 14: 5.1 Option 1 - Fixation Plate/Grid
Page 15 and 16: 5.2 Option 2 - Positioning Unit The
Page 17 and 18: Removal Start-up To remove the late
Page 19 and 20: • Detect the marker block (1) and
Page 21 and 22: Localization and Biopsy Process •
Page 23 and 24: • Perform the biopsy in accordanc
Page 25 and 26: 6.2 with Positioning Device Localiz
Page 27 and 28: 2 Fiducial Marker, right Localizati
Page 31 and 32: • The patient is then brought out
Page 33 and 34: • Draw in a suitable angle (-30°
Page 37 and 38: 6.2.1 Post&Pillar Adaptor for Ethic
Page 39 and 40: After the adjustment of the calcula
Page 41 and 42: 6.3 Safety Information Please consi
Page 43 and 44: Closing Markers Localization and Bi
Page 45 and 46: 7.2 Disinfection All components of
Page 47 and 48: 7.3 Sterilization Sterilization aft
Page 49 and 50: 8.3 Waste Disposal Maintenance, Sto
Page 51 and 52: 9.2 Performance Data Operating Temp
Page 53 and 54: Declaration of Conformity DRAFT DRA
Page 55 and 56: 11. Important Addresses Important A
Page 57 and 58:
13. Training Certifi cate Training
Page 59 and 60:
15. Warranty Registration Device/De
show all

Manual BI160-GE - NORAS MRI products GmbH

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?