CorPath® GRX System Operator’s Manual CorPath GRX Operator’s Manual Important Safety Notice to Users of the Corindus CorPath GRX System 1 This manual and the equipment it describes are for use only by qualified medical professionals with adequate training and experience in angiographic procedures and use of the CorPath GRX System. It is intended as a guide for both system components and cassette. It is important that operating instructions and user warnings supplied with the CorPath GRX System be read, understood and followed. Please do not hesitate to contact Corindus if additional training resources are needed. Patent Information The CorPath GRX system and cassette may be covered by or for use under US patent numbers 6726675; 7615042; 7887549; 8399871; 8480618; 8828021; D626250; D674484; D680645; and D685468; and Non-US patent numbers DE69919851.8, FR/EP 1061990, IL162318, GB/EP 1061990, IE/EP 1061990, IT/EP 1061990, DE/EP 1755727; FR/EP 1755727; GE/EP 1755727; and IT/EP 1755727 and other pending US and Non-US patent applications. Reproduction of this manual is strictly prohibited without the express written consent of Corindus, Inc. CorPath is a trademark of Corindus © 2017 Corindus Inc. All rights reserved. 150-07582 Rev C CorPath GRX Operator’s Manual Section 1. General Information ............................................................................................. 5 1 Definitions ......................................................................................................................................... 5 Description ........................................................................................................................................ 5 A. Indication for Use, Warnings and Precautions .............................................................................. 7 Section 2. Clinical Data .......................................................................................................... 8 Section 3. System Description .............................................................................................. 15 A. CorPath GRX Components ......................................................................................................... 15 B. Control Console ........................................................................................................................ 15 C. Touchscreen ............................................................................................................................. 16 D. Extended Reach Arm and Robotic Drive ..................................................................................... 17 E. Single-use Cassette ................................................................................................................... 18 The long white support track, encapsulates and supports the guide catheter ..................................... 19 Section 4. Software Description............................................................................................ 20 Section 5. Safety Information ............................................................................................... 21 A. Emergency Stop Controls .......................................................................................................... 21 B. Electrical Safety ........................................................................................................................ 21 C. Electro Magnetic Compatibility (EMC) ....................................................................................... 23 D. Anesthetics, Oxygen and Fire Hazards ....................................................................................... 23 E. Sterilization .............................................................................................................................. 23 Section 6. CorPath GRX System Installation .......................................................................... 24 A. Re-attaching Extended Reach Arm to Procedure Table ............................................................... 24 B. Re-installing the Robotic Drive .................................................................................................. 25 C. Removing Extended Reach Arm and Robotic Drive from Procedure Table ................................... 26 D. Re-connecting Control Console and Bedside Unit ....................................................................... 27 Section 7. System Operation ................................................................................................ 29 A. System Power-up ...................................................................................................................... 29 B. Bedside Touchscreen ................................................................................................................ 30 C. Control Console Touchscreen Controls ....................................................................................... 31 D. Joystick Operation .................................................................................................................... 32 E. Guidewire and Device Speed and Direction Indicators................................................................ 34 F. Discrete Controls ...................................................................................................................... 36 150-07582 Rev C CorPath GRX Operator’s Manual G. Guide Catheter Indicators ......................................................................................................... 37 2 H. CorPath Measurement Function ................................................................................................ 38 I. Traction Notification ................................................................................................................. 39 J. Pushability Notification ............................................................................................................. 40 K. Obstacle Notification ................................................................................................................ 40 L. Sheath Notification ................................................................................................................... 41 M. Motion Limit Notification ...................................................................................................... 41 N. Extended Reach Arm Controls ................................................................................................... 42 O. Shutting Down the System ........................................................................................................ 44 Section 8. Performing a Procedure ....................................................................................... 45 A. Manual Preparations ................................................................................................................ 45 B. Draping the CorPath GRX System .............................................................................................. 45 C. Preparing Proximal End of Guide Catheter ................................................................................. 49 D. Attaching Single-use Cassette .................................................................................................... 50 E. Positioning Extended Reach Arm for Case .................................................................................. 52 F. Loading Guide Catheter ............................................................................................................. 54 G. Loading Guidewire into Single-use Cassette ............................................................................... 56 H. Loading Device .......................................................................................................................... 58 I. Exchanging a Wire or Device ..................................................................................................... 60 J. Exchanging a Guide Catheter ..................................................................................................... 61 K. Finishing the Case ..................................................................................................................... 63 L. Switching to Manual Operation - Power Failure or System Malfunction ..................................... 66 Section 9. Cleaning, Maintenance and Calibration ................................................................ 68 A. Cleaning ................................................................................................................................... 68 B. Maintenance ............................................................................................................................ 68 C. Calibration ................................................................................................................................ 69 Section 10. Menu ................................................................................................................... 69 Section 11. Troubleshooting ................................................................................................... 70 A. Problem Solving ........................................................................................................................ 70 B. Loading Devices into the System ............................................................................................... 71 C. Operating the System ..............................................................................................................