CorPath GRX System Operator s Manual

Transcription

1 CorPath GRX System Operator s Manual

2 Important Safety Notice to Users of the Corindus CorPath GRX System 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. 1 Patent Information The CorPath GRX system and cassette may be covered by or for use under US patent numbers ; ; ; ; ; ; D626250; D674484; D680645; and D685468; and Non-US patent numbers DE , FR/EP , IL162318, GB/EP , IE/EP , IT/EP , DE/EP ; FR/EP ; GE/EP ; and IT/EP 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.

3 Section 1. General Information... 5 Definitions Description... 5 A. Indication for Use, Warnings and Precautions... 7 Section 2. Clinical Data... 8 Section 3. System Description A. CorPath GRX Components B. Control Console C. Touchscreen D. Extended Reach Arm and Robotic Drive E. Single-use Cassette The long white support track, encapsulates and supports the guide catheter Section 4. Software Description Section 5. Safety Information A. Emergency Stop Controls B. Electrical Safety C. Electro Magnetic Compatibility (EMC) D. Anesthetics, Oxygen and Fire Hazards E. Sterilization Section 6. CorPath GRX System Installation A. Re-attaching Extended Reach Arm to Procedure Table B. Re-installing the Robotic Drive C. Removing Extended Reach Arm and Robotic Drive from Procedure Table D. Re-connecting Control Console and Bedside Unit Section 7. System Operation A. System Power-up B. Bedside Touchscreen C. Control Console Touchscreen Controls D. Joystick Operation E. Guidewire and Device Speed and Direction Indicators F. Discrete Controls... 36

4 G. Guide Catheter Indicators H. CorPath Measurement Function I. Traction Notification J. Pushability Notification K. Obstacle Notification L. Sheath Notification M. Motion Limit Notification N. Extended Reach Arm Controls O. Shutting Down the System Section 8. Performing a Procedure A. Manual Preparations B. Draping the CorPath GRX System C. Preparing Proximal End of Guide Catheter D. Attaching Single-use Cassette E. Positioning Extended Reach Arm for Case F. Loading Guide Catheter G. Loading Guidewire into Single-use Cassette H. Loading Device I. Exchanging a Wire or Device J. Exchanging a Guide Catheter K. Finishing the Case L. Switching to Manual Operation - Power Failure or System Malfunction Section 9. Cleaning, Maintenance and Calibration A. Cleaning B. Maintenance C. Calibration Section 10. Menu Section 11. Troubleshooting A. Problem Solving B. Loading Devices into the System C. Operating the System... 72

5 D. System Fault Messages E. Replacement Cassette Errors Appendix A. Technical Specifications Appendix B. Replacement Parts and Consumable Supplies Appendix C. Electromagnetic Compatibility Information Appendix D. Symbol Descriptions List of Figures Figure 3-1: Control Console Top View Figure 3-2: Control Console Rear Panel Figure 3-3 Control Console Touchscreen Controls Figure 3-4 Robotic Drive and Extended Reach Arm Figure 3-5 Single-Use Cassette Figure 5-1: Emergency Stop Buttons Figure 6-1: Mounting Arrangement for Extended Reach Arm Figure 6-2: Mounting Robotic Drive to Extended Reach Arm Figure 6-3: Stowing Bedside Unit Figure 6-4: Push the button left and rotate up to remove Figure 6-5: Cable Connections and Power Button Figure 6-6: Cable Connections to Junction Box Figure 6-7: Interventional Cockpit with Control Console Figure 7-1: Bedside Touchscreen Figure 7-2: Control Console Touchscreen Figure 7-3: Individual Joystick Disable Figure 7-4: Joystick Linear Control Function Figure 7-5: Guidewire & Guide Catheter Joystick Rotational Function Figure 7-6: Guidewire; Speed and Direction Indicators Figure 7-7: Device; Speed and Direction Indicators Figure 7-8: Discrete Controls Figure 7-9: Guide Catheter Linear Travel Indicator Figure 7-10: Guide Catheter Rotation Indicator Figure 7-11: Measuring Distance Figure 7-12: Device and Guidewire Measurement Indicators Figure 7-13: Traction Notification Figure 7-14: Pushability Notification Figure 7-15: Obstacle Notification Figure 7-16: Sheath Notification Figure 7-17: Motion Limit Notification Figure 7-18: Extended Reach Arm Joints and Controls Figure 7-19: Minimum Arm Angle Figure 7-20: Fine-tune Controls Figure 7-21: Stowing Bedside Unit Figure 8-1: Minimum exposed Guide Catheter length needed to load into Single-Use Cassette... 45

6 Figure 8-2: Unfolding Drape Figure 8-3: Lifting Drape Figure 8-4: Remove backing from adhesive tabs on faceplate Figure 8-5: Portion of Drape covering Bedside Touchscreen Figure 8-6: Aligning face plate with protrusions on Robotic Drive Figure 8-7: Snapping Drape in place over Track Clamp Figure 8-8: Removing Temporary Face Plate Cover Figure 8-9: Draping Control Console Figure 8-10: Drive Gear and Y-Connector Junction Figure 8-11: Drive Gear and Guide Catheter connection Figure 8-12: Attaching Cassette to Robotic Drive Figure 8-13: Track Clamp connected to Robotic Drive with lever unlocked Figure 8-14 Unclip Support Track and Remove Orange Key Figure 8-16: Cassette test failure, possibly orange key in place Figure 8-17: Tilting Robotic Drive Counterclockwise 30 degrees Figure 8-18: Loading Guide Catheter Figure 8-19: Rail Clamp Release Lever Figure 8-20: Robotic Drive, Fine-tune Controls Figure 8-21: Loading Y-Connector Figure 8-22: Gently Pull Support Track Figure 8-23: Attaching Support Track to Introducer Sheath Figure 8-24: Locking Track Clamp Figure 8-25: System prompt to prepare to load guidewire Figure 8-26: Tilting Y-Connector Holder Figure 8-27: Placing Guidewire Figure 8-28: Control Console Touchscreen Figure 8-29: Enabled Control Console Touchscreen Figure 8-30: Load/Exchange Devices on Bedside Touchscreen Figure 8-31: System prompt to prepare to load Device Figure 8-32: Anchoring Guidewire Figure 8-33: Loading Device Figure 8-34: Placing Device in Single-use Cassette Figure 8-35: Loading Device Figure 8-36: Placing Device Figure 8-37: Bedside Touchscreen Figure 8-38: Removing Guide Catheter Figure 8-39: Ending the Case Figure 8-40: Removing Guide Catheter Figure 8-41: Releasing Cassette Figure 8-42: Allow Robotic Drive to Center Figure 8-43 Level the Robotic Drive Figure 8-44: Stowing Bedside Unit Figure 8-45: Removing Guide Catheter and Unload Devices Figure 8-46: Rotary Drive Release Figure 8-47: Removing Rotary Drive Figure 10-1 System Setting Options and System Status

7 5 Section 1. General Information Definitions The following abbreviations are used in this manual: Abbr. Description CTO chronic total occlusion EMC electromagnetic compatibility GW guidewire LAD left anterior descending artery LCX left circumflex artery LED light-emitting diode RX Rapid Exchange PCI PVI percutaneous coronary intervention percutaneous vascular intervention Description The CorPath GRX System is intended for use in the remote delivery and manipulation of coronary or peripheral guidewires, rapid exchange devices and guide catheters during percutaneous coronary intervention (PCI) procedures and percutaneous vascular intervention (PVI) procedures. The complete CorPath GRX System includes the following major components: The Bedside Components consist of an Extended Reach Arm, Robotic Drive and Single-use Cassette. The Extended Reach Arm is mounted on a bed rail and supports the Robotic Drive. Robotic Drive: Receives inputs from the Control Console. These inputs actuate mechanical operations in Single-use Cassette as movements to a loaded guidewire, RX device, and guide catheter. The Robotic Drive moves forward and backwards to advance and retract the guide catheter. A Bedside Touchscreen on the Robotic Drive provides the user interface for bedside operator during system set-up, loading and device exchanges. Single-use Cassette: Attaches to the Robotic Drive and can be loaded with commercially available guide catheters, guidewires, and RX devices. This Single-use Cassette advances, retracts, and rotates the guidewire, advances and retracts the RX device, and rotates the guide catheter. Extended Reach Arm: Mounted on the rail of the procedure table and supports the Robotic Drive. The Interventional Cockpit, houses the Control Console, the X-ray Foot Pedal, and Monitor(s) to display angiographic and hemodynamic data. It is designed to protect the physician from radiation exposure while maneuvering interventional devices.

8 Control Console: Enables the physician to remotely manipulate the guide catheter, guidewire, and RX device. The Control Console has a touchscreen and three joysticks: one joystick for RX device manipulation, one for guidewire manipulation, and a third joystick for guide catheter manipulation. 6 The CorPath GRX System Control Console and Robotic Drive work together via a communication cable. The physician s commands are communicated to the Robotic Drive using either the touchscreen or the joysticks. Control Console Touchscreen operation advances and retracts the RX device, guidewire, or guide catheter in discrete 1mm steps. The Control Console Touchscreen can also be used to rotate the guidewire in 30 increments. The joystick controls maneuver the catheters or guidewire in a continuous mode. During advancement of the catheters or guidewire, the system provides continuous, distinct audible sounds indicating to the operator the speed the device is traveling. An audible change in the frequency of the sounds indicates a change in the speed of device travel. If the rotational and linear functions are operated simultaneously, the audible beep for the linear function will override the audible sound for the rotational function. Figure 1-1 CorPath GRX System

9 A. Indication for Use, Warnings and Precautions Indications for Use: The CorPath GRX System is intended for the use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. 7 Contraindications: Warnings: Precautions: None known The CorPath GRX System should only be used by qualified personnel familiar with PCI / PVI techniques after they have successfully completed the CorPath GRX System training program (which includes didactic and hands-on sessions with the CorPath GRX System utilizing a vascular model). The devices should not be moved with CorPath GRX System without fluoroscopic visualization. The turbo function should not be used when the guidewire or RX device is intraarterial or outside the guide catheter. The turbo function must only be used when the guidewire and RX device are in the guide catheter. The guide catheter should be manually engaged by physician; the CorPath guide catheter control function is intended to maintain or adjust engagement. The CorPath GRX System is recommended for the following device sizes: Guidewire: diameter Rapid Exchange Catheter: compatible with guidewires and a proximal shaft diameter of 2.3 French Guide Catheter: 5-7 French The CorPath GRX System is recommended for use with the Abbott Vascular COPILOT Bleedback Control Valve (Y-Connector). The use of other Y-Connectors with the CorPath GRX System has not been evaluated. The CorPath GRX System has not been evaluated for neurovascular stent placement, atherectomy, or with the use of self-expanding stents. The CorPath GRX System has not been evaluated in chronic total occlusions (CTOs), ostial lesions, and moderately to severely calcified lesions.

10 Section 2. Clinical Data 8 Summary of GLP Study of the CorPath GRX System Background The safety and technical efficacy of the CorPath GRX System to manipulate coronary guide catheters for use in percutaneous coronary interventions (PCI) procedures was evaluated in an animal study. The objectives of this prospective non-randomized controlled study were to: Demonstrate, by histological examination, the safety of CorPath GRX System to manipulate coronary guide catheters used in PCI compared to manual PCI; Characterize 1) the ease of use and operational performance of the CorPath GRX System using prespecified scoring criteria to obtain a subjective assessment from the operator, and 2) intraprocedural parameters. Twelve pigs underwent PCI (balloon angioplasty and stent deployment) of the mid left anterior descending artery (LAD) performed either by manual PCI (M-PCI) or by robotic PCI (R-PCI) with the CorPath GRX System. Six animals each were enrolled into one of two groups, a 24 hour and 30-day survival group. In each time point cohort, four animals were treated with R-PCI and two animals were treated M-PCI. In addition, the operator provided feedback on five variables comparing the CorPath GRX System to the operator s experience with the traditional manual approach. The five variables assessed were ability to: (1) maintain guide catheter position while advancing devices; (2) adjust guide catheter orientation to obtain coaxial alignment; (3) deep-seat the guide catheter to increase backup support; (4) withdraw guide catheter to avoid coronary occlusion; and (5) redirect the guide catheter to selectively engage the LAD. Histologic sections were evaluated for endothelial loss, surface thrombi, adherent platelets/fibrin, vessel wall injury, hemorrhage, inflammation, and calcification. Results None of the twelve animals experienced any significant pre-, intra-, or post-operative adverse events, and balloon angioplasty and stent deployment were successfully performed in all cases. In addition, all eight robotic cases were successfully completed with the CorPath GRX System without conversion to manual operation. All animals recovered from the procedure and survived to the pre-defined time of sacrifice. Conclusions No major events such as death, artery perforation, or thrombosis occurred during any PCI. Operator feedback on procedural system performance was rated equivalent to or better than manual intervention in all robotically treated animals. X-ray time and contrast volume used was similar in both groups with no statistically significant differences between R-PCI and M-PCI. Interventional procedure time for the M-PCI group was shorter when compared to R-PCI, although the mean difference of less than four minutes would not be considered clinically meaningful. There were no in-life or clinical pathology changes suggestive of health abnormalities or possible adverse effects of the PCI procedure. There were no abnormal gross necropsy findings related to the test articles or implant sites. By histopathologic assessment, one guidewire

11 injury was seen in the left coronary cusp of a 24-hour R-PCI animal; this was not identified during the initial PCI procedure, and no filling anomalies or other findings were visible upon review of the angiography. Otherwise injury related to the PCI procedure was minimal across all animals at both time points. No differences were seen in semi-quantified scored parameters between CorPath GRX or Manual PCI methods at either time point. 9 PRECISE Study of the CorPath 200 System The CorPath 200 System was evaluated in the PRECISE Clinical Study. The PRECISE Clinical Study was a prospective, single-arm, multi-center, nonrandomized study of the CorPath 200 System. The objective of the study was to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath 200 System in the delivery and manipulation of coronary guidewires and stent/balloon devices for use in PCI procedures. One hundred and sixty-four (164) subjects were enrolled and evaluated in the PRECISE Clinical Study at nine (9) clinical sites. The overall rate of clinical procedural success was 97.6%. One hundred percent of subjects achieved post-procedure stenosis of less than 30% (as evaluated by a Core Laboratory) and 97.6% of subjects had an absence of Major Adverse Cardiac Events (MACE). The overall device technical success rate was 98.8%. Although there were some limitations with the collection of operator radiation exposure data, the PRECISE trial results show a reduction in radiation exposure to the primary operator For Tables 1 to 6 listed below, the PRECISE clinical study utilized the following study definitions: *ITT (Intent to Treat Population): consists of all subjects for whom the guidewire insertion using the CorPath 200 System was attempted, including the roll-in subjects. **MITT (Modified Intent to Treat Population): is identified as a subset of the ITT population with exclusion of the roll-in subjects (first 3 subjects of each investigator). **PP (Per-Protocol Population): is identified as a subset of the MITT population and consists of subjects who complete the study without any major protocol deviations. Table 1 Co-Primary Effectiveness Endpoint Clinical Procedural Success and Technical Success¹ ITT* (N=164) MITT** (N=104) PP*** (N=103) Clinical Procedural Success 2, n (%) 160/164 (97.6%) 102/104 (98.1%) 101/103 (98.1%) 95% confidence interval Comprise of both: post-procedure stenosis < 30% 164/164 (100%) 104/104 (100%) 103/103 (100%) absence of MACE 160/164 (97.6%) 102/104 (98.1%) 101/103 (98.1%) Device Technical Success 4, n (%) 162/164 (98.8%) 102/104 (98.1%) 101/103 (98.1%) 95% confidence interval Study success is based upon achievement of success in both co-primary endpoints. 2 Clinical Procedural Success is comprised of post-procedure stenosis less than 30% as measured by QCA by the core lab and the absence of MACE prior to hospital discharge as adjudicated by the CEC. 3 one-sided 95% exact confidence interval 4 Device Technical Success is comprised of successful advancement and retraction of the PCI devices using the CorPath 200 system without conversion to manual operation.

12 Table 2 Pre-Procedure Characteristics (Visual Estimates) ITT* MITT** PP*** (N=103) (N=164) (N=104) Mean ±SD 54.9 ± ± ±7.1 LVEF measurement (%) Median Min, Max 30.0, , , 69.0 RCA 60 (36.6%) 44 (42.3%) 44 (42.7%) LCX 35 (21.3%) 21 (20.2%) 21 (20.4%) LAD 53 (32.3%) 32 (30.8%) 31 (30.1%) Lesion Location, n (%) Posterior 2 (1.2%) 1 (0.96%) 1 (0.97%) descending Ramus 8 (4.9%) 4 (3.8%) 4 (3.9%) 1 st Diagonal 2 (1.2%) 1 (0.96%) 1 (0.97%) Obtuse 4 (2.4%) 1 (0.96%) 1 (0.97%) Marginal Mean ±SD 13.4 ± ± ± 4.0 Lesion Length (mm) Median Min, Max 5.0, , , 24.0 Mean ±SD 3.0 ± ± ± 0.43 Reference Vessel Diameter Median (mm) Min, Max 2.5, , , 4.0 Percent Diameter Stenosis Mean ±SD 78.1 ± ± ±10.0 (%) Median Min, Max 50.0, , , (0%) 0 (0%) 0 (0%) TIMI Flow, n (%) I 0 (0%) 0 (0%) 0 (0%) II 4 (2.4%) 1 (0.96%) 1 (0.97%) III (99.0%) 102 (99.0%) (97.6%) Mild (99.0%) 102 (99.0%) Vessel Tortuosity (%) (95.7%) Moderate 7 (4.3%) 1 (0.96%) 1 (0.97%) Severe 0 (0%) 0 (0%) 0 (0%) Lesion Angulation (>45), n, (%) Yes No 0 (0%) 164 (100%) 0 (0%) 104 (100%) 0 (0%) 103 (100%) Eccentricity, n (%) Yes 91 (55.5%) 59 (56.7%) 58 (56.3%) No 73 (44.5%) 45 (43.3%) 45 (43.7%) None 79 (48.2%) 59 (56.7%) 58 (56.3%) Calcification, n (%) Mild 81 (49.4%) 44 (42.3%) 44 (42.7%) Moderate 4 (2.4%) 1 (0.96%) 1 (0.97%) Severe 0 (0%) 0 (0%) 0 (0%) Evidence of thrombus within lesion, n (%) Yes No 0 (0%) 164 (100%) 0 (0%) 104 (100%) 0 (0%) 103 (100%) 10

13 Table 3 Procedure Characteristics ITT* (N=164) MITT** (N=104) PP*** (N=103) Number of stents placed (92.7%) 93 (89.4%) 92 (89.3%) 2 9 (5.5%) 8 (7.7%) 8 (7.8%) 3 3 (1.8%) 3 (2.9%) 3 (2.9%) 11 Average number of stents placed Reason for additional stents, n (%) 1 Fluoroscopy time (min) Total x-ray time (min) Contrast volume (ml) Subject cumulative dose (mgy) 2 DAP (cgy*cm 2 ) Mean (SD) 1.1 ± ± ±0.42 Median Min, Max 1,3 1,3 1,3 Geographic miss 1 (7.7%) 1 (8.3%) 1 (8.3%) Plaque shifted 4 (30.8%) 4 (33.3%) 4 (33.3%) Dissection 8 (61.5%) 7 (58.3%) 7 (58.3%) Insufficient lesion coverage 0 (0%) 0 (0%) 0 (0%) Mean (SD) 10.6 ± ± ±4.4 Median Min, Max 2.1, , , 31.5 Mean (SD) 11.1 ± ± ±4.8 Median Min, Max 3.3, , , 31.5 Mean (SD) ± ± ±79.0 Median Min, Max 20.0, , , Mean (SD) ± ± ±637.8 Median Min, Max 421.1, , , Mean (SD) ± ± ± Median Min, Max 1298, , , One subject had 2 stents placed due to both a geographic miss and a dissection and therefore is counted in both categories.

14 Table 4 Secondary Safety Endpoints ITT* (N=164) MITT** (N=104) PP*** (N=103) Number (%) of subjects with event Number (%) of subjects with event Number (%) of subjects with event In-hospital MACE 1 4 (2.4%) 2 (1.9%) 2 (1.9%) MACE 1 at 30-days postprocedure 0 (0.0%) 0 (0.0%) 0 (0.0%) Overall Adverse Event Rate 56 (34.1%) 34 (32.7%) 34 (33.0%) 1 As adjudicated by the CEC 12 In-hospital MACE (primary endpoint definition) Table 5 CEC Adjudicated MACE Events ITT* (N=164) MITT** (N=104) PP*** (N=103) Number (%) of subjects with event Number (%) of subjects with event Number (%) of subjects with event 4 (2.4%) 2 (1.9%) 2 (1.9%) Cardiac Death ɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MI ɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MI ɸ2 4 (2.4%) 2 (1.9%) 2 (1.9%) TVR ɸ3 0 (0.0%) 0 (0.0%) 0 (0.0%) In-hospital MACE(h) 2 (1.2%) 1 (0.96%) 1 (0.96%) (secondary endpoint definition) Cardiac Death ɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MI ɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MI ɸ2 2 (1.2%) 1 (0.96%) 1 (0.96%) TVR ɸ3 0 (0.0%) 0 (0.0%) 0 (0.0%) MACE at 30 days FU 0 (0.0%) 0 (0.0%) 0 (0.0%) Cardiac Death ɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MI ɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MI ɸ2 0 (0.0%) 0 (0.0%) 0 (0.0%) TVR ɸ3 0 (0.0%) 0 (0.0%) 0 (0.0%) MACE Major Adverse Cardiac Event is defined as cardiac death, Q-wave or non Q-wave myocardial infarction (MI), or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods. ɸ Cardiac Death: Death due to cardiac causes. If the cause of death cannot be determined, it will be categorized as cardiac. MI Myocardial Infarction a positive diagnosis of periprocedural myocardial infarction is made when one of the following criteria are met: ɸ1 Q wave MI (QWMI) (1) chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in two or more contiguous ECG leads as determined by an ECG core laboratory or independent review of the CEC, in the absence of timely cardiac enzyme data; (2) new pathologic Q waves in two or more contiguous ECG leads as determined by an ECG core laboratory or independent review of the CEC and elevation of cardiac enzymes above normal. ɸ2 Non-Q Wave MI (NQWMI) (Primary Endpoint): defined as elevated CK-MB >3X the laboratory upper limit of normal in the absence of new pathological Q waves. Non-Q Wave MI (NQWMI) (Secondary Endpoint): defined as elevated CK 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal) in the absence of new pathological Q waves. ɸ3 TVR Target Vessel Revascularization-defined as ischemia-driven repeat PCI of the target vessel or bypass surgery of the target vessel.

15 PRECISE Clinical Trial: Conversion to Manual PCI 13 There were two cases (1.2%) of conversion from CorPath PCI to a manual PCI. In both instances the conversion to manual process went very quickly and smoothly and did not compromise subject s safety. They are summarized as follows: Case 1 A stent catheter was blocked from advancing by the structure (one of the struts wasn t fully open) of the old previous deployed stent in the proximal RCA. The procedure was converted to manual PCI due to the complexity of the procedure. The manual procedure was successfully completed and final angiography revealed good results with no residual stenosis and TIMI 3 flow distally. Case 2 Using the CorPath system a guidewire and pre-dilatation balloon were successfully delivered but two attempted to advance the stent catheter were met with resistance in the proximal part of the RCA with the push-back of the guide catheter. A second pre-dilatation balloon was introduced and deployed leading to a linear dissection that was not flow-limiting. At this point the procedure was converted to manual operation with 3 stents successfully placed with excellent final angiogram with TIMI 3 flow. Patient was asymptomatic at the end of the procedure, with no ECG changes. There were no myocardial enzyme elevations after the procedure including the next day. Table 6 Device Malfunctions/Observations ITT* (N=164) Malfunctions, n (%) 22 (13.4%) During set-up 10 (45.5%) During procedure 12 (54.5%) Recovered and continued with CorPath PCI 22 (100%) CorPath PCI abandoned due to malfunction 0 (0%) CorPath PCI converted to manual due to malfunction 0 (0%) Adverse Events related to malfunctions 0 (0%) Component that malfunctioned, n (%): Cassette 17 (77.3%) Robotic Drive 2 (9.1%) Control Console 1 (4.5%) Extended Reach Arm 0 (0.0%) Other 2 (9.1%)

16 Rapid Study A prospective, single center, multi-operator, non-randomized, single arm study (RAPID) was conducted to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in the peripheral vasculature. 14 The study enrolled 20 subjects with a total of 29 lesions. Feasibility Endpoint was device technical success, defined as the successful cannulation of the target vessel using the CorPath 200 system. The Safety Endpoint was no device-related serious adverse events (SAEs) during the procedure. Clinical procedure success was defined as less than 50% residual stenosis at procedure completion, without an unplanned switch to manual procedure in the absence of device-related SAEs. Clinical Study Outcome Results Device Technical Success (Successful target vessel cannulation) 20/20 (100%) Safety Endpoint (Absence of SAEs during procedure) 20/20 (100%) Clinical Procedural Success 20/20 (100%) The study results demonstrated the successful cannulation and treatment of all 29 lesions by the CorPath System. There were no device related adverse events or procedure-related serious adverse events. Clinical procedural success was achieved in all cases.

17 Section 3. System Description A. CorPath GRX Components The complete CorPath GRX System includes the following units: - Control Console - Robotic Drive - Extended Reach Arm - Single-use Cassette - Interventional Cockpit 15 B. Control Console Touchscreen Emergency Stop Turbo Button Guide Catheter Joystick RX Device Joystick Guidewire Joystick Control Console Components Power On/Off Button Turbo Button RX Device Joystick Guidewire Joystick Guide Catheter Joystick Active Joystick LEDs E-Stop (Emergency Stop) Figure 3-1: Control Console Top View Located in back of the console, turns power on and off to the console Increases advancement or retraction speed of guidewire and RX device by 5x Turbo mode is not available for the guide catheter. Advances and retracts the RX device when enabled Advances, retracts, and rotates guidewire when enabled Advances, retracts, and rotates guide catheter when enabled Green LED next to each joystick indicates when joysticks are active. Joystick is active when Control Console is enabled and sensor on joystick surface senses touch. Disables power to Robotic Drive. Use in event of emergency only Control Console Power On/Off Button Figure 3-2: Control Console Rear Panel

18 C. Touchscreen 16 Enable/Disable All Icon Enable/Disable each Icon Individually Measurement Indicators 1 mm Advance and Retract Guide Catheter Distance Indicator Rotation Indicator Linear Travel Indicator 1 mm Advance and Retract Control Console Touchscreen Components Enable All and Touching Enable All illuminates the screen and enables joysticks and Disable All Button Touchscreen functions. Touching Disable All dims the screen and disables RX Device and Guidewire Measurement Indicators 1 mm Advance and Retract joystick and Touchscreen functions. The window displays movements of RX device and guidewire in mm. Touching the Save button saves the number displayed above the Reset button. Touching Reset button sets indicator to 0 The 1mm icon advances and retracts RX device, guidewire, or guide catheter in 1 mm increments Speed Indicators Displays direction and speed of guidewire and RX device movement 30 Rotation Control Rotates guidewire clockwise or counter-clockwise in discrete 30 increments Guide Catheter Travel Indicator The window displays guide catheter travel movement. + indicates advance, - indicates retract. Touching Reset button sets indicator to 0 Guide Catheter Linear Travel Indicator Guide Catheter Rotation Indicator Speed Indicators 30 Wire Rotation Controls 3-3 Control Console Touchscreen Controls The ruler displays linear travel distance available to advance and retract guide catheter. The Green bar indicates current position relative to travel distance. If the green bar is inside yellow zones at either end of ruler, <10mm is left to advance or retract guide catheter. The indicator displays degrees rotation of guide catheter. + is clockwise, - is counterclockwise. Touching Reset button sets indicator to 0. The arrow indicates rotation direction. Color brightens with increasing number of revolutions in one direction

19 D. Extended Reach Arm and Robotic Drive Emergency -Stop Power Indicator Optical Sensor Track Clamp Holder Extended Reach Arm 17 Bedside Touchscreen Emergency Arm Release Obstacle Sensor Arm Unlock Button Robotic Drive Handle Fine-tune Controls Robotic Drive Bed Support Rail Clamp Figure 3-4 Robotic Drive and Extended Reach Arm Rail Clamp Release Lever Robotic Drive Components Bedside Touchscreen Power Indicator E-Stop (Emergency Stop) Fine-Tune Controls Track Clamp Holder Arm Unlock Button The interface tool for bedside operator during system set-up, loading and exchanges The light indicates power connected to the bedside unit E-Stop disables power to Robotic Drive. Use in event of emergency only Use to fine-tune location of the Robotic Drive if needed before loading guide catheter onto the cassette The track clamp holder attaches to Track Clamp on Single-use Cassette The white button, unlocks Extended Reach Arm to enable positioning Obstacle Sensor This force sensor on the distal end of Robotic Drive that detects the presence of an obstacle in the path of the Robotic Drive and notifies user. Optical (Sheath) Sensor Detects location of Robotic Drive relative to introducer sheath; LED light turns on after cassette attach to detect movement of Guide Catheter Support Track Extended Reach Arm Components Rail Clamp The rail clamp attaches the Extended Reach Arm securely to bed rail Bed Support The supports positioned under bed mattress to support Extended Reach Arm Rail Clamp Release Lever The silver lever unlocks Extended Reach Arm to allow it to slide on rail Emergency Arm Release The emergency lever, overrides Extended Reach Arm lock; to be used in case of power outage or system fault where Arm Unlock Button is disabled.

20 E. Single-use Cassette Locking Lever Linear Pinch Handle 18 Track Clamp Guide Catheter Track Aux. Device Holder Rotational Gate Linear Gate Orange Key Auxiliary Device Holder Button Aux. Device Path Sheath Retainer Y-Connector Holder Wire Holder Drive Gear Y-Connector Figure 3-5 Single-Use Cassette Rotary Drive Release

21 Single-use Cassette Components Y-Connector Holder Holds the Y-Connector in place 19 Guide Catheter Support Track Track Clamp Sheath Retainer Drive Gear Rotational Gate Linear Gate Auxiliary Device Path Auxiliary Device Holder Auxiliary Device Holder Button Linear Pinch Handle Orange Key Wire Holder Rotary Drive Release The long white support track, encapsulates and supports the guide catheter When locked, the track clamp enables linear movement of guide catheter by fixing support track in place. Lock the lever to enable guide catheter control The plastic sheath retainer connects Guide Catheter Support Track to introducer sheath White gear connector between guide catheter and Y-Connector that enables rotation of guide catheter Captures guidewire in Rotary Track Captures guidewire and RX device in Linear Drive Track Path for placing additional auxiliary devices. Devices in Auxiliary Device Path are not manipulated by CorPath Control Console unless they are moved to the active track Feature inside Auxiliary Device Path to help user to hold one auxiliary device in place within the Single-use Cassette When pressed, button opens Auxiliary Device Holder to allow placement of a device inside the holder Enables removal of PCI / PVI devices, in the event of power loss, via manual turn The orange key secures Rotary Drive during shipment Fixates guidewire when introducing the RX device When pressed, allows the Rotary Drive portion of Single-use Cassette to be removed, releasing guidewire. Intended for use in the event of power outage

22 Section 4. Software Description The CorPath GRX System software is designed to operate with parameters proven to execute manipulation of guide catheters, guidewires, and RX devices. The software offers the option for continuous motion or discrete step movement of devices. It also continuously monitors the joystick positions and interprets the inputs for minimum and maximum speeds. 20 The system includes several important features that ensure operation and optimal safety for the patient: Distinct audible tones sound an alert when the guide catheter, guidewire and/or RX device are moving. As the speed is increased, the tones become more rapid. If the joystick is deactivated and the operator moves it, an audible alert will sound. The touch screens convey useful guidance and information to the operator. The software will disable the touch screen and joysticks if the Control Console is not accessed within two (2) minutes. Any faults, warnings, or cautions that occur in the system are reported and displayed on the Touchscreen. The system also produces an audible tone to alert the operator. The software prevents the ability to perform motions using the joystick(s) and the Touchscreen simultaneously. Faults disable the system. If there is a failure in the software, the system will disable all controls and shut down the motor actuators. The software confirms the communication between the Robotic Drive and the Control Console. Either of the Emergency Stop (E-stop) buttons will deactivate the controls and motors when pressed, removing power to all aspects of the bedside unit except the bedside screen display.

23 Section 5. Safety Information This section includes important safety-related information. Please review this section carefully before the operating the system. 21 A. Emergency Stop Controls The system is equipped with two Emergency Stop (E-Stop) buttons: Control Console Robotic Drive Engagement of either E-Stop interrupts power to the Robotic Drive. After it s engaged, an E-Stop may be reset by turning it clockwise. Emergency Stops Control Console E-Stop E-Stop Robotic Drive Figure 5-1: Emergency Stop Buttons B. Electrical Safety The CorPath GRX System is classified as Class 1 medical system, with Type CF applied part rating for the guide wire and catheter accessories, in accordance with IEC :2005/AMD1:2012, ed 3.1, including national/regional version: ANSI/AAMI ES :2005 & A1:2012; US differences CAN/CSA-C22.2 NO :14, Canadian differences EN :2006/A1:2013; EU and EFTA country differences The system is safe for continuous use. CorPath GRX Control Console meets the vertical drip-proof fluid ingress classification of IPX1, and the Robotic Drive meets the angled drip-proof fluid ingress classification of IPX2 in accordance with IEC

24 Warning: No modification of this equipment or system is allowed. Caution: The equipment uses a medical grade power supply to isolate equipment from the supply mains. 22 Warning: Electrical Shock Hazard only use the power cord supplied with the CorPath GRX System. Do not plug the CorPath GRX System power cord into an extension cord or multi-outlet power strip. Warning: The Extended Reach Arm shall be connected to potential equalization conductor of the table or ground. Warning: Electrical Shock Hazard Operator injury could result from worn cabling or disassembly of the unit. To avoid exposure to potentially hazardous voltages, do not disassemble the CorPath GRX System outside of the instructions in this manual. Worn cabling also creates voltage hazards. If you detect any worn or damaged cables, do not use the system. Contact Corindus Technical Support for assistance at or Caution: Damage to the power supplies may occur if they are supplied with the incorrect voltages. Verify that the voltage and frequency from the electrical outlets are compatible with the rated voltages and frequencies on the backs of the power supplies provided with the CorPath GRX System. In order to disconnect this device from the mains, disconnect the power cord from the wall. Ensure access to the power cord is not blocked at all times. The only power supplies approved for use with the CorPath GRX System is described below. No other power supplies should be substituted or exchanged for use in the CorPath GRX System. Specific ordering information for replacement parts can be found in Appendix B. CorPath GRX System Authorized Power Supplies CorPath GRX Subsystem Corindus Part Number Power Supply Used Output Voltage/Power Mains Input Voltage/Frequency/Power Control Console XP Power (model # AHM180PS12) 12VDC/ 165W VAC/50-60-HZ/ 140W Robotic Drive International Components, Inc. (model # 06-5MWA150024A-12A ) 24VDC/ 150W VAC/50-60Hz/ 165W

25 C. Electro Magnetic Compatibility (EMC) The CorPath GRX System has been tested and found to be in compliance with International Standard IEC : 2005, General Requirements for Basic Safety and Essential Performance. Appendix C lists adequate precautions which must be taken to ensure continued EMC compliance for the particular environment of use. 23 D. Anesthetics, Oxygen and Fire Hazards Warning: Explosion Hazard. Explosion risk may exist if the system is used in the presence of flammable anesthetic mixtures and/or flammable agents used for disinfection or cleaning. E. Sterilization The CorPath GRX Single-use Cassette and all single-use CorPath GRX consumable supplies (Appendix B) are provided pre-sterilized via ethylene oxide (EtO) in accordance with the requirements of ISO 11135, and are intended for single patient use. To ensure proper sterile technique, open the Single-use Cassette package after the Robotic Drive and Extended Reach Arm have been draped and the system is turned on. Warning: Biological contamination can result from reusing disposable items or failing to follow sterile technique. None of the CorPath GRX System reusable components are suitable for sterilization. Warning: The Single-use Cassette and all CorPath GRX single-use consumables are incompatible with resterilization. The risk of re-use is infection to the patient and compromised functionality of the CorPath 200 System. After use, properly discard the Single-use Cassette and other single-use consumables as hazardous medical waste in accordance with local regulations. The CorPath GRX Cassette and all CorPath GRX consumables are single-use, pre-sterilized devices; they should never be used on more than one patient. Warning: Patient injury may result if the package is opened or damaged prior to use, or if damaged components are used. Visually inspect the package and contents before each use. If there is any possibility that contamination may have occurred during set-up or use, remove the contaminated Single-use Cassette and replace it with a new sterile Single-use Cassette.

26 Section 6. CorPath GRX System Installation This section includes information on installing the CorPath GRX System in a room equipped for CorPath GRX System integration. Securing Extended Reach Arm to the bed rail Attaching Robotic Drive Connecting cables Caution: Damage may occur if the table rail cannot support a minimum vertical static load of 45 kg (100 lbs or 423 N). Before installing the Extended Reach Arm, ensure that the table rail can support this load. Caution: Additional medical equipment attached to the table rail that is not part of the CorPath GRX System must be accounted for when evaluating the total load on the table rail. Refer to the documentation supplied by the table manufacturer for weight load information. 24 Caution: Do not tilt or cradle the table while the CorPath GRX system is mounted on the table Caution: Personnel installing the CorPath GRX system should be capable of lifting 30 kg (65 lbs) without injury. Caution: When the Robotic Drive is not attached to the Extended Reach Arm, activating the Emergency Arm Release will result in an upward motion of the arm. Use caution to prevent accidental unlock of Extended Reach Arm. Caution: Do not force the arm s table mount bracket onto the table rail. Forcing the arm s table mount bracket onto a table rail of the incorrect size could damage the bracket or table rail. Caution: No parts of this device can be serviced while in use on a patient. A. Re-attaching Extended Reach Arm to Procedure Table The CorPath GRX System should be installed by Corindus service personnel and it is recommended that the Extended Reach Arm and Robotic Drive remain on the bed rail at all times. If it becomes necessary for a user to temporarily remove the system from the bedrail, follow the instructions below to safely remove and properly re-attach the system to the procedure table. 1. Adjust the table to the appropriate height 2. Align the CorPath GRX rail clamp to the rail 3. While depressing Rail Clamp Release Lever, slide Extended Reach Arm onto bed rail. 4. Continuing to depress Release Lever, position arm such that the distal end of the rail clamp is positioned 70 inches from head of the table (Figure 6-1). Release Lever Rail Clamp Bed Support Figure 6-1: Mounting Arrangement for Extended Reach Arm

27 The Extended Reach Arm is designed to be positioned in this location such that it will not need to be moved on the rail to reach the intended access site for the majority of patients The Extended Reach Arm should slide easily on the table and appear perpendicular to table rail. Caution: Upon installation, ensure that Extended Reach Arm will not interfere with X-ray equipment movement. B. Re-installing the Robotic Drive 1. Lift the Robotic Drive and slide its mounting connector into receptacle on the Extended Reach Arm (Figure 6-2) [Arrow #1]. 2. The Robotic Drive should match the opposing socket such that the post fits to the end of the slot. 3. Allow the Robotic Drive, by gravity, to rotate towards the user [Arrow #2]. 4. The spring loaded button will automatically lock the slotted joint in place once rotated. 5. Connect the power cable with from the Extended Reach Arm to connector on the back of the arm extension on the Robotic Drive. (Align both red dots to connect) Figure 6-2: Mounting Robotic Drive to Extended Reach Arm

28 C. Removing Extended Reach Arm and Robotic Drive from Procedure Table Ensure the Extended Reach Arm is in the stowage position (See Figure 6-3) Joint 2 Joint : Stowing Bedside Unit Figure 1. Put the arm in stowage position, but rotate the Robotic to 90 degrees across the table. 2. Disconnect the power cable with from the Extended Reach Arm from the connector on the back of the arm extension on the Robotic Drive. 3. Disconnect communication cable from the junction box on back of Extended Reach Arm. 4. Disconnect 24V power supply cable to junction box. 5. Push the spring-loaded silver button by pushing it left (arrow 1), and rotate the arm upwards (arrow 2) to the large slot (arrow 3). a. While rotating, let go of the button and hold both ends of the Robotic Drive. Figure 6-4: Push the button left and rotate up to remove 6. Slide the Robotic Drive out from the arm slot (arrow 3) while holding the drive and place on a flat surface. Warning: Joint 2 of the Extended Reach Arm will move upwards abruptly if the emergency release is pulled after the Robotic Drive has been removed. Keep clear of the space above Joint 2 of the Extended Reach Arm.

29 7. Adjust the table height to the appropriate height. 8. Depress the Rail Clamp Release Lever and slide the Extended Reach Arm off bed rail. 9. Store the system in a secure location to prevent damage. 27 D. Re-connecting Control Console and Bedside Unit The Interventional Cockpit, Control Console, and associated cabling will be installed by Corindus Service Personnel. If the cables need to be temporarily disconnected, follow instructions below to re-connect. Note: The connectors and receptacles are keyed, or marked to show proper pin alignment. When making connections, be sure the RED dots on the connectors and receptacles line up with each other. In addition, make sure the pin count of the connector matches the pin count of the receptacle. 1. Align the red dot to connect Communication Cable to the connector on back right side of Extended Reach Arm (see Figure 6-3). Console Power Button Communication Cable connector Power Cable connector Figure 6-5: Cable Connections and Power Button 2. Attach the Power Supply Cable to the PWR connector on Console rear panel. 3. Attach the Communication Cable to the COM connector on the Console rear panel. (See Figure 6-5) Note: USB ports on rear panel should only be utilized by authorized Corindus personnel Junction Box Potential Equalization Conductor 24V Power Supply Cable Communication Cable Figure 6-6: Cable Connections to Junction Box

30 1. Connect the 24V Power Supply cable to the connector on the left-hand side of back of Extended Reach Arm The Extended Reach Arm should be connected to potential equalization conductor of the table or ground (see Figure 6-6). 3. Connect power cables from Extended Reach Arm to hospital main and Control Console power cables to Corindus-supplied power strip. 4. The potential of the bedside unit can be equalized to that of the table, by connecting the bedside unit to the table using the potential equalization connector see Figure 6-6, in accordance with IEC (2012) Caution: Damage to power supplies may occur if they are supplied with incorrect voltage. Verify that voltage and frequencies from electrical outlets are compatible with rated voltages and frequencies on backs of power supplies provided with CorPath GRX System. Warning: Connecting equipment other than Corindus authorized equipment to the power strip creates an ME System that may result in reduced level of safety which voids Corindus warranty and responsibility for product safety performance.

31 29 Figure 6-7: Interventional Cockpit with Control Console Section 7. System Operation A. System Power-up Power up the Control Console by pressing and holding down the Power button on console s rear panel for 3 seconds. The blue LED on the Power button will light up. The system will run a power-up self-test. Following a successful power-up self-test, the system will run a Robotic Drive self-test to check functionality of Robotic Drive prior to installation of Single-use Cassette. The touch screens will prompt operator to install Single-use Cassette. Note: If a Single-use Cassette is present at power up, system will prompt operator to check if it is a new Single-use Cassette or an existing one. If the operator indicates an existing Single-use Cassette, the system will skip the Robotic Drive self-test and the cassette test.

32 B. Bedside Touchscreen 30 Figure 7-1: Bedside Touchscreen The Bedside Touchscreen provides prompts to the bedside operator and is the interface tool for system setup, loading, and device exchanges. (See Figure 7-1) When the Bedside functions are active (enabled), Control Console functions are disabled.

33 C. Control Console Touchscreen Controls 31 Shows drive controls enabled and displays feedback of those controls when operator activates them Figure 7-2: Control Console Touchscreen Shows drive controls disabled and allows operator to activate controls via Enable All function In order to drive devices, joysticks and touchscreen controls are enabled by pressing Enable All button on Touchscreen: (See figure 7-2 right side) When the screen is enabled, Touchscreen controls will become visible on the screen When the screen is disabled Touchscreen controls will be grayed out. (See Figure 7-2) As a safety feature, after two minutes of inactivity, the Touchscreen will be automatically disabled To individually disable one joystick, press the button with the device name (RX Device, Guidewire or Guide Catheter) on the Control Console Touchscreen when screen is enabled. (See Figure 7-3) Press button with device name for individual joystick disable Figure 7-3: Individual Joystick Disable Note: The joysticks will only be active when they are enabled on the Control Console Touchscreen and the user touches the joystick. (A sensor on the joystick will sense the user touch with or without gloves). A lit green LED next to each joystick indicates when the joystick is active.

34 D. Joystick Operation Three joysticks are located on Control Console: the left joystick controls the RX device (example balloon catheter or stent catheter), for the central joystick controls the guidewire, and the right joystick controls the guide catheter. 32 Advancing and Retracting the RX Catheter Device, Guidewire and Guide Catheter: Figure 7-4: Joystick Linear Control Function When a given joystick moves forward (away from operator), the guide catheter, guidewire, or RX device will advance into patient. If the joystick moves back (toward operator), the guide catheter, guidewire or RX device retracts. The farther the joystick is moved forward or back, the greater speed of advancement or retraction. During joystick movement of the RX device, guidewire, or guide catheter, the system provides distinct audible sounds for each device. The Control Console Touchscreen will illuminate the panel for the device being operated via joystick. The guide catheter can be advanced or retracted at a maximum speed of 24 mm per second. The guidewire and RX device advance or retract at a maximum speed of 12 mm per second in coronaries. When moving the guidewire and RX device outside coronaries, operator may increase the guidewire or RX device speed to a maximum of 60 mm per second by pressing and holding Turbo Button while joystick is engaged. Warning: The Turbo function should not be used when guidewire or RX device is intra-arterial. The Turbo function must only be used when guidewire and RX device are in guide catheter. Caution: Moving the guide catheter forward or backward will move, as a single unit, the Robotic Drive and any guidewires or RX devices loaded on Single-use Cassette. To maintain the guidewire and RX device in place while moving the guide catheter, user may move guidewire and RX device joysticks in opposite direction as guide catheter joystick. Caution: When operator moves joystick forward to advance guide catheter, Robotic Drive moves towards patient. A sensor on the distal end of Robotic Drive detects the presence of an obstacle in the path of the Robotic Drive and notifies user. Ensure area between Robotic Drive and patient is clear, and monitor access site during procedure.

35 Rotating Guidewire and Guide Catheter: In addition to advance/retract function, joysticks for guide catheter and guidewire have rotational control. To rotate guide catheter or guidewire in a clockwise direction, turn joystick clockwise. To rotate guide catheter or guidewire in a counterclockwise direction, turn joystick counterclockwise. (See Figure 7-5) 33 The further the operator turns the joystick knob, the more rapidly the guide catheter or guidewire rotates. Guide catheter or guidewire will continue to rotate as long as operator holds joystick knob in place. Rotation and advance/retract functions may be used simultaneously. Guidewire and guide catheter can be rotated slow to fast, counterclockwise or clockwise Figure 7-5: Guidewire & Guide Catheter Joystick Rotational Function Caution: Similar to manual rotation, continuous rotation of guide catheter in same direction can result in torque build-up at the distal end of the guide catheter. Monitor guide catheter on fluoroscopy and Guide Catheter Rotation Indicator on Control Console screen. User has option to relieve potential torque build-up by rotating guide catheter in opposite direction.

36 E. Guidewire and RX Device Speed and Direction Indicators 34 As the joystick is advanced or retracted, the speed indicator will light. Figure 7-6: Guidewire; Speed and Direction Indicators Advancement: Illumination will advance toward the plus sign and get higher with greater speed Retraction: Illumination will advance toward the minus sign and get lower with greater speed Turbo Function: The speed indicator lights will change to blue when this function is used for advancement and retraction. Turbo Function is not available for rotation Rotation speed and direction: Illumination will move right for clockwise and left for counterclockwise Touching Reset button sets indicator to 0. The guidewire and RX device each have distinct audio feedback. Note: Touching reset does not move test guidewire; it only changes the display.

37 35 When Turbo Function is used, lights will change to blue. Figure 7-7: RX Device; Speed and Direction Indicators As the joystick is advanced or retracted the speed indictor will illuminate green When the Turbo Function is used, lights will change to blue. Advancement will illuminate toward the plus sign and get higher with greater speed Retraction will illuminate toward the minus sign and get lower with greater speed Touching Reset button sets indicator to 0. Note: Touching reset does not move RX device; it only changes the display.

38 F. Discrete Controls 36 1mm Advance/Retract 30 Rotation Increments Figure 7-8: Discrete Controls For enhanced control, the Touchscreen provides ability to advance or retract the Device, Guidewire, or Guide Catheter 1 mm at a time. The guidewire may be rotated in 30 increments in a clockwise or counterclockwise direction. (See Figure 7-8) Note: Repeated Touchscreen inputs are not queued; the system must complete one motion before recognizing subsequent Touchscreen inputs.

39 G. Guide Catheter Indicators 37 Figure 7-9: Guide Catheter Linear Travel Indicator The CorPath GRX system allows for a guide catheter linear travel of up to 200 mm. When the Y-Connector is loaded onto the Robotic Drive at the Robotic Drive s central position, the guide catheter can be robotically advanced up to 100 mm and retracted up to 100 mm. The green bar depicts the location of the distal end of the guide catheter within the robotic travel range. If green bar is inside yellow zone at the top of the ruler, less than 10 mm of linear distance remains to advance the guide catheter. If green bar is inside yellow zone at the bottom of the ruler, less than 10mm of linear distance to retract the guide catheter. (See Figure 7-9) After 1 revolution 360 degrees + After 2 revolutions 720 degrees + Figure 7-10: Guide Catheter Rotation Indicator The rotation indicator window displays the first 999 degrees of guide catheter rotation. + is clockwise, - is counterclockwise. Touching Reset button sets indicator to 0. (See Figure 7-10) Note: Touching reset does not move guide catheter; it only changes the display.

40 The arrow indicates direction the guide catheter is being rotated by operator. Color of rotation graphic will brighten after one, two, and three revolutions in a single direction. 38 Note: The maximum rotational is 90 degrees per second or 4 seconds per revolution. Note: The distinct audio beep for guide rotation will have one beep each 15 degrees or 24 beeps for a full revolution. Similar to manual manipulation of the guide catheter the physician must exercise care to maintain their normal clinical judgment while manipulating the Guide Catheter with the CorPath GRX system. If the guide catheter joystick is advanced, retracted or rotated, it will correspondingly move at the proximal end and the physician must continuously visually watch the display to ensure the appropriate distal end reaction. H. CorPath Measurement Function End Point 23.4 mm Start Point Figure 7-11: Measuring Distance The measurement feature may be useful for determining the linear distance between two points. To use this function, use a device marker. Examples of device markers include proximal end or transition point on a radiopaque wire tip or a balloon catheter. 1. Using the guidewire or RX device joystick or the RX discrete controls, advance marker at least 10 mm distal to the distal edge of segment to be measured. 2. Pull back the marker until it is at distal edge of segment, so that marker is at site where measurement will begin. (See Figure 7-11) 3. Touch the Reset button on the Touchscreen for appropriate device (either guidewire or RX device); it will register 0.0. (See Figure 7-12) 4. Begin the measurement by retracting the guidewire or to desired location. When marker is at proximal edge, watch for length on measurement display. Measurement Indicator will display distance traveled in millimeters. (See Figure 7-12)

41 5. To save that value and measure again, touch Save button and value will move to Save window; touch Reset button to start over. 39 Note: Most accurate reading is obtained by using retraction. A forward or back-and-forth motion provides least accurate measurement. I. Traction Notification Figure 7-12: Device and Guidewire Measurement Indicators Figure 7-13: Traction Notification The above reduced traction icon (See Figure 7-13) can be seen on either Guidewire or Device portions of Control Console screen. It indicates that the CorPath GRX System has detected a loss of traction on either RX device or guidewire. For continuous traction notifications see Troubleshooting, Repeated Traction Notification in Operating the System on page 72.

42 J. Pushability Notification 40 Figure 7-14: Pushability Notification The pushability icon can be seen on either the Guidewire or Device portions of Control Console screen. (See Figure 7-14) It indicates that the CorPath GRX System has reached its maximum drive force limit on either the RX device or guidewire. For continuous pushability notifications see Troubleshooting, Repeated Pushability Notification in Operating the System section. K. Obstacle Notification Figure 7-15: Obstacle Notification The above icon will be displayed on guide catheter portion of the Control Console screen if the CorPath GRX System detects that an obstacle is in the path of the Robotic Drive. (See Figure 7-15) Forward motion of the guide catheter will be disabled as a safety feature until the obstacle is removed. The user may still retract and rotate the guide catheter during obstacle notifications.

43 L. Sheath Notification 41 Figure 7-16: Sheath Notification The above icon will be displayed on the guide catheter portion of the Control Console screen when the CorPath GRX System detects that the cassette has reached the introducer sheath retainer. (See Figure 7-16) Forward motion of the guide catheter will be disabled as a safety feature to ensure the sheath is not perturbed. The user may still rotate and retract the guide catheter during sheath notifications. M. Motion Limit Notification Figure 7-17: Motion Limit Notification The above icons will be displayed on the guide catheter portion of the Control Console screen when the CorPath GRX System reaches its motion limits for advancing or retracting guide catheter. (See Figure 7-17)

44 N. Extended Reach Arm Controls There are several joints on the Extended Reach Arm. Joint #2 is a Friction Joint. All other joints are electrically locked by the system. The green Arm Unlock Button on the Robotic Drive handle unlocks Joints #3 and #4, and allows for arm height adjustments and positioning of the arm relative to the patient. In the event of a power outage or a system fault that results in lack of power to the Extended Reach Arm, the Emergency Arm Release lever may be used to override the arm lock. (See Figure 7-18) 42 Joint #2 (Friction Joint) Arm-to-Robotic Drive Attachment Joint #1 Robotic Drive Pitch Angle Joint #3 Joint #4 Mast Emergency Arm Release Fine-tune Controls Arm Unlock Button Figure 7-18: Extended Reach Arm Joints and Controls Rail Clamp Release Lever Joint #1 is utilized to position the Robotic Drive at the appropriate angle for the case. The system will automatically unlock Joint #1 at the start of a case, after the cassette is attached and tested, and the touchscreen will prompt the user to tilt the robotic drive. The Robotic Drive will be locked at the 30 degree tilt angle for the case. The system will unlock Joint #1 again at the end of a case and prompt the user to level the robotic drive back to its horizontal, stowage position.

45 When positioning the Extended Reach Arm for a procedure, in rare situations (for example, when positioning the product for left-side access in tall patients), a notification may appear on the Bedside Touchscreen: (See Figure 7-19) 43 Figure 7-19: Minimum Arm Angle This notification indicates that the system has detected that the Friction Joint is at an angle below 80 degrees. A minimum of 80 degrees is required to ensure that when the user moves the Robotic Drive to retract the guide catheter, the Robotic Drive will not interfere with the Extended Reach Arm. The arm should be slid on the bed rail as indicated on Figure 7-19 to allow the angle to widen. To move Extended Reach Arm on bedrail, press Rail Clamp Release Lever and slide arm. The notification on the Bedside Touchscreen will disappear as soon as the Friction Joint is repositioned at or beyond the minimum 80 degree angle. Once the Extended Reach Arm has been positioned in place for the case, the user has the option to fine tune the location of the Robotic Drive if desired. The Fine-tune Controls (See Figure 7-20) allow the user to move the Robotic Drive up to 25mm in either direction without repositioning the Extended Reach Arm. Note: The arm Unlock Button is disabled during procedures to prevent accidental movement of any devices. Caution: Do not use the emergency release lever to move the arm while the devices are loaded. Figure 7-20: Fine-tune Controls

46 When not in use, the Robotic Drive and Extended Reach Arm should be maintained on the bed rail in the stowage position as depicted. (See Figure 21) 44 To position the system in stowage position: 1. Remove cassette and follow system prompts to level Robotic Drive. 2. Press the Arm Unlock Button and position Robotic Drive such that the top arm segment is parallel to the bed rail and the angled arm segment is below the Stow label on the mast. 3. Without pressing the Arm Unlock Button, angle Friction Joint to position Robotic Drive as shown in Figure 21. Figure 7-21: Stowing Bedside Unit Caution: The Bedside unit should be maintained over the rail or over the bed. Stow CorPath GRX in the recommended stowage position. Damage to bed or injury to user may result if the weight of the bedside unit is allowed to extend beyond the bed rail. O. Shutting Down the System To shut down the CorPath GRX system, press the Power button at the back of the Control Console, or choose the "Menu" button on the Control Console Touchscreen and select "Shutdown".

47 Section 8. Performing a Procedure A. Manual Preparations The operator must manually perform the following: 45 Initial guide catheter intubation and engagement in coronary ostium or peripheral vasculature Loading or exchanging of guide catheters, guidewires, RX devices (ex. balloons, and stent systems) Contrast injections C-arm movements Balloon inflations Medication administration Note: The CorPath GRX system requires a minimum of 12.4cm of guide catheter length (including its hub) exposed outside the introducer sheath in order to load the guide catheter into the Single-use Cassette. (See Figure 8-1) Figure 8-1: Minimum exposed Guide Catheter length needed to load into Single-Use Cassette The maximum length of exposed guide catheter for compatibility with CorPath GRX is 45cm. This should be considered during guide catheter length selection. Power up the CorPath GRX system, allow it to perform a self-test, and proceed with the steps below. B. Draping the CorPath GRX System The Robotic Drive and Extended Reach Arm should be draped with a CorPath GRX Robotic Drive Drape prior to every CorPath procedure. Draping Robotic Drive and Extended Reach Arm Note: Be sure to follow proper aseptic technique during draping. 1. From the stowage position, angle the Friction Joint on the Extended Reach Arm to extend arm across the bed and position the Robotic Drive in place for draping. 2. Remove the drape from the package according to aseptic technique. 3. Place drape down on a sterile surface with blue arrows on the right side of the operator (see Figure 8-2). Unfold right (Arrow 1) and left (Arrow 2) folds. Unfold bottom fold (Arrow 3).

48 46 Figure 8-2: Unfolding Drape 4. Insert left hand under the long flap (Figure 8-3) Hand should be directly above the Remove label. Lift drape by holding the face plate to create a tunnel. Figure 8-3: Lifting Drape 5. (Optional) Remove the backing of the adhesive tabs under the face plate. Figure 8-4: Remove backing from adhesive tabs on faceplate 6. Place the drape over the Robotic Drive and find the touchscreen cover of the drape that s immediately next to the face plate and marked with a white strip (See Figure 8-5). Cover the Touchscreen. Figure 8-5: Portion of Drape covering Bedside Touchscreen

49 7. Align the cut-out areas of the face plate with the protrusions on the face of the Robotic Drive and secure the face plate with the adhesive tabs. Note: There is a thin material temporarily covering the face plate, which is designed to help ensure the operator does not touch the non-sterile protrusions on the Robotic Drive during draping. This temporary cover is removed after the arm is fully draped, before attaching Single-use Cassette. (See Figure 8-6) 47 Figure 8-6: Aligning face plate with protrusions on Robotic Drive 8. Place drape over the Track Clamp using the tabs, such that it completely covers the Track Clamp and does not interfere with the cassette. Fix the Track Clamp cover in place by snapping it onto its mating part on the Robotic Drive. (See Figure 8-7) Figure 8-7: Snapping Drape in place over Track Clamp 9. Pull the sleeve of the drape over the Extended Reach Arm to its base. This may be done with the help of a second, non-sterile operator. Ensure the portion of the Extended Reach Arm extending over the sterile

50 field is completely covered. 10. Remove the temporary face plate cover before attaching Single-use Cassette. (See Figure 8-8) 48 Figure 8-8: Removing Temporary Face Plate Cover Draping Control Console and Cockpit Chair The Control Console and cockpit chair can be covered with sterile drapes if the operator wishes to be scrubbed during the procedure. Proceed with draping Control Console and chair to provide an appropriate sterile field for procedure. (See Figure 8-9) Note: Use aseptic technique when draping the control console and cockpit chair. 1. Remove drape from package according to aseptic technique. 2. Place drape on front of Control Console and wrap around top of console. 3. Unfold side sections of drape to cover Interventional Cockpit. 4. Secure sides with adhesive tabs. 5. Unfold front of drape so it covers front of Interventional Cockpit. 6. Cover each of the three joysticks.

51 49 Figure 8-9: Draping Control Console 7. Place cockpit chair drape over back of chair according to aseptic technique. C. Preparing Proximal End of Guide Catheter It is recommended that the Drive Gear be connected to Y-Connector and the guide catheter before engaging the guide catheter in the coronary ostium or the peripheral vasculature. Figure 8-10: Drive Gear and Y-Connector Junction 1. Remove the Drive Gear from its package according to aseptic technique. 2. Connect the Drive Gear to the Y-Connector (See Figure 8-10). 3. Connect the Drive Gear to the guide catheter (See Figure 8-11). Use care to attach the Drive Gear firmly. Figure 8-11: Drive Gear and Guide Catheter connection

52 Note: Check Luer connections for leaks and tighten as necessary to avoid loss of pressure during procedure. 50 Guide catheter is now ready to be manually engaged in coronary ostium or the peripheral vasculature according to standard PCI / PVI practice. D. Attaching Single-use Cassette 1. Remove the Single-use Cassette from sterile package according to aseptic technique. 2. Attach the Single-use Cassette to the draped Robotic Drive by aligning the cassette over the Optical Sensor and positioning the tab at the back of the cassette under the recess in the Robotic Drive. Note: Ensure the tab in the back of the Single-use Cassette is under the recess in the Robotic Drive; if it s not positioned appropriately, Track Clamp cannot be attached. (See Figure 8-12). Figure 8-12: Attaching Cassette to Robotic Drive Optical Sensor 3. Press down on Track Clamp to connect it into Track Clamp Holder. The Track Clamp Lever should be in the unlocked position. (Figure 8-13). Figure 8-13: Track Clamp connected to Robotic Drive with lever unlocked 4. The CorPath GRX system will recognize the Single-use Cassette and prompt the user to continue. Unclip the Guide Catheter Support Track from the front of the cassette so that the track can straighten. (Figure 8-14) [Arrow #1.] 5. Open the Rotary Drive Cover; remove Orange Key. (See Figure 8-14) [Arrow #2]

53 51 Figure 8-14 Unclip Support Track and Remove Orange Key 6. Align Rotary Drive with Linear Drive (Figure 8-14) [Arrow #3], and close cover [Arrow #4]. Note: System will not operate with Orange Key in place Figure 8-15: Cassette test failure, possibly orange key in place. Single-use Cassette will perform an automated self-test. When test is complete, Bedside Touchscreen will instruct user to tilt the Robotic Drive 7. Tilt the Robotic Drive in counterclockwise direction until it is tilted 30 degrees towards the patient and cannot be rotated further. The system will automatically lock the Robotic Drive at this angle for the intervention, and prompt user to load guide catheter. (See Figure 8-16)

54 Figure 8-16: Tilting Robotic Drive Counterclockwise 30 degrees E. Positioning Extended Reach Arm for Case Press Arm the Unlock Button on the Robotic Drive Handle to unlock the Extended Reach Arm. While pressing the unlock button, position the Robotic Drive to align it with the axis of the introducer sheath and guide catheter. The Cassette should be positioned so that the Y-Connector reaches the Y-Connector Holder comfortably, without tugging the guide catheter, or hanging with excess slack. (See Figure 8-17). Figure 8-17: Loading Guide Catheter 2. If it s necessary to move the Extended Reach Arm on the rail in order to position the Robotic Drive for the case, press the Rail Clamp Release Lever to slide arm on rail. See Figure Caution: Ensure the guide catheter or devices are NOT loaded onto the Single-use Cassette anytime you move Extended Reach Arm Caution: Keep fingers away from Extended Reach Arm joints when positioning arm. Caution: When loading the guide catheter ensure that the support track and guide catheter are positioned to align with the sheath to minimize the bending the guide.

55 Figure 8-18: Rail Clamp Release Lever Caution: Tugging on the guide catheter during system set-up can result in unintended motion at distal end of the guide catheter. Exercise caution and keep the guide catheter steady when loading If after manual movement of Extended Reach Arm, Y-Connector is not aligned with Y-Connector Holder, use Robotic Drive Fine-tune Controls (See Figure 8-19) to fine-tune the location of the Robotic Drive before loading the guide catheter onto cassette. The system allows movement up to 25 mm in either direction with the Fine-tune Controls. If additional movement is necessary, reposition the Robotic Drive using the Extended Reach Arm. Caution: Ensure the guide catheter and devices are NOT loaded onto the cassette when using fine-tune controls. Figure 8-19: Robotic Drive, Fine-tune Controls

56 F. Loading Guide Catheter 1. Open lid on Y-Connector Holder. 2. Position the Drive Gear in Y-Connector Holder as shown in Figure 8-20 [Arrow #1]. Hold Drive the Gear in place while rotating Y-Connector as needed to position the Y-Connector as shown. Ensure Y- Connector is properly seated in the Y-Connector Holder and that Y-Connector Holder lid can close fully. 54 Figure 8-20: Loading Y-Connector 3. Position the guide catheter so the drive gear fits inside the slot at distal end of the cassette as shown in Figure 8-20 [Arrow #2]. The guide catheter must completely sit within the middle of the sheath retainer to aid in encapsulation. The support track completely encapsulates the guide catheter. 4. Close lid of Y-Connector Holder. 5. Gently pull Guide Catheter Support Track out from cassette, so that it completely encapsulates guide catheter. (See Figure 8-21) Figure 8-21: Gently Pull Support Track 6. Hold on to the introducer sheath to ensure the guide catheter and sheath do not move.

57 7. While aligning the gap in the sheath retainer to the sheath port, attach the support track to the introducer sheath by capturing the sheath port in the sheath retainer. Use left hand with some force to rotate the white proximal end of the sheath retainer towards user as shown in Figure The white retainer has friction spots to ensure sheath retention for a secure support track. 55 Figure 8-22: Attaching Support Track to Introducer Sheath Caution: Monitor the access site throughout the setup and the procedure to ensure introducer the sheath and the guide catheter are not inadvertently moved. 8. Turn lever on Track Clamp clockwise 180 degrees so that it is in locked position. The Robotic Drive is now ready for guidewire and device loading. (See Figure 8-23) Figure 8-23: Locking Track Clamp Caution: System will not operate if the Track Clamp is unlocked. Note: The bedside controls are disabled when the Track Clamp is in locked position

58 56 G. Loading Guidewire into Single-use Cassette 1. When prompted by the system, open cassette cover, Rotary Gate and Linear Gate. (See Figure 8-24) Figure 8-24: System prompt to prepare to load guidewire Caution: System will rotate the Linear Pinch Handle to allow loading/unloading of the guidewire and devices, and to grip guidewire and devices after loading is complete. Keep fingers away from Linear Pinch Handle while it is being moved by the system. 2. Lift lever on the Y-Connector Holder to tilt it upward for improved access. (See Figure 8-25) Figure 8-25: Tilting Y-Connector Holder 3. Insert the guidewire through a guidewire introducer and into the Y-Connector. Advance the guidewire a short distance until the floppy portion of wire is inside guide catheter. Remove wire introducer. Note: The operator may load RX Device on guidewire at this point, provided s/he knows which type of device will be used. See instructions in section titled Loading Device. 4. Compress levers on the Y-Connector Holder and tilt Y-Connector Holder down until it clicks in place. 5. Gently maneuver the guidewire into guidewire track. (See Figure 8-26)

59 57 6. Close the cassette cover and gates. Figure 8-26: Placing Guidewire Warning: Do not move the Extended Reach Arm or Robotic Drive when guide catheter, guidewire, or device(s) are loaded onto the Single-use Cassette. 7. Touch the Enable All button on the Control Console to activate joysticks and Touchscreen. The Touchscreen controls will become visible on the screen. (See Figure 8-27) Shows drive controls disabled and allows operator to activate controls via Enable All function Shows drive controls enabled and displays feedback of those controls when operator activates them Figure 8-27: Control Console Touchscreen

60 8. Use joysticks and/or Touchscreen controls to navigate guidewire to target location. (See Figure 8-28) 58 Figure 8-28: Enabled Control Console Touchscreen H. Loading Device Press Load/Exchange Devices on bedside Touchscreen. (See Figure 8-29) Figure 8-29: Load/Exchange Devices on Bedside Touchscreen

61 59 1. When prompted by the system, open cassette cover, Rotary Gate and Linear Gate. (See Figure 8-30) Figure 8-30: System prompt to prepare to load RX device 2. Lift the guidewire from wire track. 3. Lift the lever on the Y-Connector Holder to tilt the Y-Connector Holder upward for improved access. Caution: The Guidewire is no longer fixed by the system. Ensure that the guidewire position is maintained by manually holding the guidewire, or by anchoring it in the Wire Holder during loading of the RX device. Take care not to damage the guidewire when inserting into the Wire Holder. (See Figure 8-31) Figure 8-31: Anchoring Guidewire 4. Use standard PCI / PVI technique to load RX device onto guidewire until catheter is advanced into Y- Connector past its coaxial portion and to first marker. (See Figure 8-32)

62 60 Figure 8-32: Loading Device Figure 8-33: Placing Device in Single-use Cassette 5. Place the RX device into Cassette as shown by the blue catheter above. (See Figure 8-33) 6. Close the cassette cover and gates. 7. Touch the Enable All button on Control Console to activate the joysticks and Touchscreen. 8. Use the joysticks and/or Touchscreen controls to navigate the guidewire to target location. I. Exchanging a Wire or Device 1. Press Load/Exchange Devices on the bedside Touchscreen. 2. When prompted by the system, open cassette cover, Rotary Gate and Linear Gate. Caution: The Guidewire is no longer fixed by system. Ensure that guidewire position is maintained by manually holding the guidewire, or by anchoring it in the Wire Holder during loading of the RX device. Take care not to kink the guidewire when inserting it in the Wire Holder 3. Lift the guidewire and RX device from their tracks in the cassette. 4. Lift lever on Y-Connector Holder to tilt Y-Connector Holder upward for improved access. 5. Using standard PCI / PVI technique, remove the RX device from guidewire. 6. Load the new RX device onto guidewire until the catheter is advanced into the Y-Connector past its coaxial portion and to the first marker. (See Figure 8-34)

63 61 Figure 8-34: Loading Device 7. Gently remove the guidewire from the Wire Holder and tilt the Y-Connector downward until it clicks in place. Fit the guidewire into the guidewire track and the RX device into the device track. Figure 8-35: Placing Device 8. Close the cassette cover and gates. 9. Touch the Enable All button on Control Console to activate joysticks and Touchscreen. J. Exchanging a Guide Catheter 1. Press the Exchange Guide button on the Bedside Touchscreen. (See Figure 8-36) Figure 8-36: Bedside Touchscreen

64 2. Turn the Track Clamp counter clockwise to unlocked position (See Figure 8-37: [Arrow #1]. 3. Disconnect the sheath retainer from introducer sheath, by rotating the proximal end of the sheath retainer away from the user, ensuring that the sheath port is no longer captured by the sheath retainer. 4. While holding the sheath in place, pull the support track back into the Single-use Cassette (Figure 8-37: [Arrow #3] by pulling the proximal end of the support track. Ensure the support track is fully re-inserted into the cassette. 62 Figure 8-37: Removing Guide Catheter Caution: Hold the introducer sheath while disconnecting the sheath retainer to ensure the sheath is not moved. Hold the guide catheter while pulling the support track to ensure the guide does not move. 5. If the guidewire or devices are still loaded into the cassette, open the cassette cover and gates, and lift the guidewire and devices out of their tracks. Using standard PCI / PVI technique, remove the RX device and guidewire from the guide catheter. 6. Open lid on the Y-Connector Holder (See Figure 8-37) [Arrow #4] and lift the Y-Connector and guide catheter out of the Single-use Cassette. 7. Manually remove the guide catheter from the patient according to standard PCI / PVI technique. 8. Detach the distal end of the Drive Gear from the previous guide catheter. 9. Attach the distal end of the Drive Gear with Y-Connector to the new guide catheter. 10. After manually engaging the coronary ostium or peripheral vasculature with the new guide catheter, prepare to load the new guide catheter onto the Single-use Cassette. 11. Open lid of the Y-Connector Holder. 12. If needed, unlock the Extended Reach Arm and position the Robotic Drive such that Y-Connector reaches the Y-Connector Holder easily, without tugging the guide catheter, or leaving excess slack. Caution: Tugging on the guide catheter during the system set-up can result in unintended motion at distal end of the guide catheter. Exercise caution and maintain the guide catheter steady when loading. 13. If after manual movement of the Extended Reach Arm, the Y-Connector is still not well-aligned with the Y-Connector Holder, use the Robotic Drive Fine-tune Controls to fine-tune location of the Robotic Drive so that the white drive gear will fit into the slot before loading the guide catheter into the cassette. The

65 system allows movement up to 25 mm in either direction with the Fine-tune Controls. If additional movement is necessary, reposition the Robotic Drive using the Extended Reach Arm. 63 Caution: Ensure the guide catheter and devices are NOT loaded onto the Single-use Cassette when using Fine-tune Controls. 14. Position the Drive Gear in Y-Connector Holder. Ensure Y-Connector is properly seated in Y-Connector Holder and that Y-Connector Holder lid can close fully. 15. Position the guide catheter so that it fits into slot at distal end of the cassette. 16. Close lid of the Y-Connector Holder. 17. Gently pull the Guide Catheter Support Track out from the cassette, so that it completely encapsulates the guide catheter. 18. Hold onto the introducer sheath to ensure the guide catheter and sheath do not move. Attach the support track to the introducer sheath by capturing the sheath port in the sheath retainer, and rotating proximal end of the sheath retainer towards user. 19. Turn the lever on the Track Clamp clockwise 180 degrees so that it is in locked position. K. Finishing the Case 1. Press End Case on Bedside Touchscreen. (See Figure 8-38) Figure 8-38: Ending the Case 2. Turn the Track Clamp counter clockwise to the unlocked position (See Figure 8-39) [Arrow #1]. Figure 8-39: Removing Guide Catheter

66 3. Disconnect the sheath retainer from the introducer sheath, and pull the support track back into Singleuse Cassette by pulling proximal end of the support track. (See Figure 8-39) [Arrow 2] 4. While holding the sheath in place, pull the support track back into the cassette. (See Figure 8-39) [Arrow 3] 5. If the guidewire or devices are still loaded into cassette, open the cassette cover and gates, and lift the guidewire and devices out of their tracks. Using standard PCI / PVI technique, remove the RX device and guidewire from the guide catheter. 6. Open the lid of the Y-Connector Holder [Arrow #4] and lift the Y-Connector and guide catheter out of Cassette. 7. Manually remove the guide catheter from the patient according to standard PCI / PVI technique. 8. Lift the Y-Connector out of the cassette and complete rest of procedure according to standard PCI / PVI technique. Caution: Ensure all devices are removed from the cassette before moving the arm or detaching cassette. 9. Close the cassette covers and gates 10. Move the Extended Reach Arm away from patient. 11. After all the devices are unloaded from cassette, press Release Cassette on Bedside Touchscreen. 12. When prompted by the system, push and hold the Cassette Release Button [Figure 8-40, Arrow #1] and remove the Single-use Cassette from Robotic Drive. (See Figure 8-40) [Arrow 2] Discard the Single-use Cassette. 14. Remove and discard the sterile drapes. Figure 8-40: Releasing Cassette 15. The system will notify the user that the Robotic Drive is moving to Cassette Attachment Position. Clear area and press Allow on the Bedside Touchscreen shown in Figure (Ready to stow or new case) Figure 8-41: Allow Robotic Drive to Center

67 16. Follow the system prompts to level the Robotic Drive such that it is no longer tilted. 65 Figure 8-42 Level the Robotic Drive 17. To position the system in stowage position; press the Arm Unlock Button and position Robotic Drive such that the top arm segment is parallel to the bed rail, and the angled arm segment is below the Stow label on the mast. Rotate Friction Joint to position Robotic Drive as shown. (See Figure 8-43) Figure 8-43: Stowing Bedside Unit

68 L. Switching to Manual Operation - Power Failure or System Malfunction Note: To switch to manual operation when system has power, see instructions for Finishing the Case. The instructions listed below are intended for when there is a power outage or system has malfunctioned and guidewire and devices are being held in place by the system within the cassette tracks Turn Track Clamp counter clockwise to unlocked position (See Figure 8-44) [Arrow #1] Figure 8-44: Removing Guide Catheter and Unload Devices Caution: Hold the introducer sheath while disconnecting the sheath retainer to ensure sheath is not inadvertently moved. Hold the guide catheter while moving the support track to ensure the guide does not move. 2. Disconnect the sheath retainer from the introducer sheath, (See Figure 8-44) [Arrow 2] and pull the support track back into the Single-use Cassette [Arrow #3] by pulling the proximal end of the support track. Ensure the support track is fully re-inserted into the cassette. 3. Open the Single-use Cassette cover. 4. Ensure the Linear Drive is pinched; (Linear Pinch Handle in 6 o clock position) then the guidewire will not move. 5. Press the Rotary Drive Release. (See Figure 8-45) Linear Pinch Handle Rotary Drive Release Figure 8-45: Rotary Drive Release

69 6. While continuing to press the Rotary Drive Release, grasp the back portion of the Rotary Drive, lift slightly and slide it off back of the guidewire. (See Figure 8-46) 67 Figure 8-46: Removing Rotary Drive 7. Manually rotate the Linear Pinch Handle clockwise to 9 o clock position to release the guidewire and RX device pinch mechanisms. Caution: Hold the guidewire and/or RX device steady to avoid inadvertent movement in the patient. 8. Open the Linear Gate. 9. Lift the guidewire and RX device (if present) out of their tracks. Open lid on the Y-Connector Holder and lift the Y-Connector and guide catheter out of the Single-use Cassette. 10. Pull the emergency arm release lever and move the Extended Reach Arm out of the way. 11. Continue the procedure manually.

70 Section 9. Cleaning, Maintenance and Calibration The reusable components of the CorPath GRX System must be cleaned after each procedure. This can be accomplished with standard disinfecting solutions in use at healthcare facilities, such as isopropyl alcohol (IPA) based disinfectants, germicides such as Spor-Klenz, or 10% to 20% bleach solutions. 68 Warning: For all body fluid spills/contamination, follow institutional decontamination procedures. If blood has leaked inside Robotic Drive, contact Corindus Technical Service for further assistance: or Caution: Do not spray cleaning solutions directly onto the touchscreen(s). To prevent damage, wipe down the touchscreen(s) with a clean, soft non-abrasive, lint-free cloth pre-moistened with water-soluble cleaning solution. Caution: Improper or careless cleaning methods may result in equipment damage. While cleaning the outside portion of the Robotic Drive, avoid allowing any water or cleaning solutions to leak inside system components. A. Cleaning Follow the steps below when cleaning the CorPath GRX System: 1. Remove Single-use Cassette and properly dispose of it as hazardous medical waste, in accordance with local regulations, after use. 2. Remove all sterile drapes and dispose of them as hazardous medical waste, in accordance with local regulations, after use. 3. Power off the CorPath GRX System, and unplug power supplies for Control Console and Robotic Drive. 4. Wipe down Robotic Drive and Extended Reach Arm with a cleanser approved for health care use. Use clean, soft, non-abrasive, lint-free disposable wipes. Do not saturate the CorPath GRX System components with cleaning solution. Wipe system using straight deliberate motions. Do not scrub or wipe in a rotating or circular fashion. Inspect system components for any residual biological material or contrast, particularly on Robotic Drive around recesses where Single-use Cassette interfaces and in any crevices on Extended Reach Arm. Repeat cleaning steps in any area where biological material is noted. Wipe Control Console in a similar manner, paying close attention to area around the joysticks. Allow components of the CorPath GRX System to air dry for 10 to 15 minutes. Plug in power supplies for Control Console and Robotic Drive. B. Maintenance CorPath GRX System Maintenance by healthcare professionals is accomplished primarily through proper cleaning of the system following each patient procedure, as described above in this Operator s Manual. No additional maintenance of the CorPath GRX System by end user is required. Corindus recommends that the user follow the X-ray system manufacturer s instructions to clean and inspects the bed rail on the X-ray system.

71 Corindus recommends a periodic system preventive maintenance process, performed by Corindus, to maintain CorPath GRX System performance. Corindus also recommends periodic inspections of cabling and connectors for handling damage. 69 C. Calibration The CorPath GRX System is preset at the factory for all parameters and tested for optimal performance. In addition, automated self tests are performed by the CorPath Operating System during every power-up. No further calibration of the CorPath GRX system is required. Corindus recommends a periodic preventive maintenance regimen performed by Corindus to assure optimal performance of the CorPath GRX system. Section 10. Menu If the recommended troubleshooting procedures below do not resolve the problem, complete case manually and contact Corindus Technical Support at or System Settings and System Status in Menu Figure 10-1 System Setting Options and System Status

72 Section 11. Troubleshooting 70 A. Problem Solving Problem Descriptions Problem Description Trouble sliding Extended Reach Arm on bed rail Unable to position Extended Reach Arm correctly for case Unable to attach Single-use Cassette to Robotic Drive Unable to attach Track Clamp to Robotic Drive Unable to collapse Extended Reach Arm into Stowage Position Suggested Solution(s) 1. Ensure arm is not extended. Arm should be in stowage position for easiest sliding on rail 2. Push on Rail Clamp Release Lever 1. Ensure arm is mounted on the recommended portion of the rail; if required to reach target location, press Rail Clamp Release Lever and slide arm on rail as needed 2. If Bedside Touchscreen indicates that arm angle should be widened, slide arm on rail away from patient so that the arm can be further extended. 3. Use Fine-tune Controls to make slight adjustments (within +/- 25mm) if needed before loading guide catheter. Check that Arm and Robotic Drive are powered. If Arm and Robotic Drive are not powered, the green LED on Robotic Drive Bedside Touchscreen would not be lit. If so, check cables, power supply and connectors (see Communication Error). 1. Check the drape to make sure it is properly positioned to allow installation of cassette. Ensure the temporary drape plate covering has been removed, and that drape is smoothly extended over the back of the Robotic Drive. 2. If problem persists, replace the drape. 3. If problem persists, replace single-use Cassette. 1. Ensure that cassette is properly attached, and that tab protruding from the back of the cassette is UNDER backstop on the Robotic Drive. 2. If problem persists, check the drape to ensure it is properly positioned and not obstructing the back of the Robotic Drive 3. If problem persists, replace single-use Cassette. Before attempting to stow the arm, push down on the Robotic Drive such that it is below the marking indicated on the mast

73 B. Loading Devices into the System Problem Description Difficulty loading guide catheter into Singleuse Cassette Difficulty loading guidewire into Single-use Cassette Difficulty loading Device into Single-use Cassette Suggested Solution(s) 1. Pull flexible support track back into the cassette 2. Ensure Y-connector holder is flat, NOT tipped up 3. Ensure Drive Gear is properly attached between Guide Catheter and Y-Connector, and that Y- connector is seated in the Y-connector holder such that Y-connector holder lid can close fully 4. Pull out flexible support track again, ensuring support track fully encapsulates Guide Catheter, and attach sheath retainer to introducer sheath 5. Ensure Robotic Drive is aligned with axis of introducer sheath when loading Guide Catheter onto cassette 6. Ensure there is sufficient guide catheter exposed (see Section 8: Performing a Procedure) 1. Repeat loading process, ensuring the Linear Pinch Handle is in open position and guidewire is being loaded inside the guidewire track, between the cassette tires. 1. Check Single-use Cassette visually for damage. 2. If problem persists, replace Single-use Cassette. 1. Repeat loading process, ensuring the Linear Pinch Handle is in open position and RX device is being loaded inside the RX device track, between the tires. 2. When closing linear gate, hold RX device down to ensure it properly positioned. 3. Check Single-use Cassette visually for damage. 4. If problem persists, replace Single-use Cassette. 71

74 C. Operating the System Problem Description Joysticks do not respond to user input. Touchscreen controls to manipulate guide catheter, guidewire or ` do not respond to user inputs. Difficulty advancing, retracting, or rotating Guide Catheter Repeated Traction Notification on Guidewire Repeated Traction Notification on Device Repeated Pushability Notification on Guidewire Suggested Solution(s) 1. Ensure Control Console is enabled 2. Ensure LED next to each joystick lights up when Control Console is enabled and user hand moves joystick. Ensure you are holding the joystick above the base. If LED light does not light up when both of these conditions are met, contact Corindus Technical Support at or to assess the capacitive touch sensor on the joysticks. 3. If joystick LEDs light up as expected, check for lesion severity or vessel tortuosity that could account for resistance levels outside parameters under which system was designed to operate 1. Ensure Control Console is enabled 2. Check for lesion severity or vessel tortuosity that could account for resistance levels outside parameters under which system was designed to operate. 1. Ensure Drive Gear is properly attached 2. Ensure guide catheter is properly loaded onto Single-use Cassette and cassette cover can fully close 3. Ensure Guide Catheter Support Track fully encapsulates guide catheter, and sheath retainer is locked onto introducer sheath 4. CorPath GRX is designed for use with guide catheters sized 5-7F. Ensure guide catheter is proper size for use with CorPath. 1. Retract guidewire 10 to 20 mm 2. Move forward and rotate 3. Press Load/Exchange Devices on Bedside Touchscreen, open cassette cover, lift guidewire out of track, and clean with sterile gauze. Place back in cassette. 2. If problem persists, repeat loading process, ensuring the Linear Pinch Handle is in open position and guidewire is being loaded inside the guidewire track, between the cassette tires. 3. If problem persists, try new guidewire. 1. Retract RX device 10 to 20 mm. 2. Move forward. 3. If problem persists, press Load/Exchange Devices on Bedside Touchscreen, open cassette cover, lift RX device out of track, and clean with sterile gauze and place back into cassette. 4. If problem persists, repeat loading process, ensuring the Linear Pinch Handle is in open position and catheter is being loaded inside the RX device track, between the tires. 1. Check fluoroscopy image to confirm location of guidewire and confirm no obstructions. 2. Retract guidewire, rotate, and move forward. 3. Check for lesion severity or vessel tortuosity that could account for resistance levels outside parameters under which system was designed to operate. 72

75 Problem Description Repeated Pushability Notification on Device Repeated Sheath Notification Repeated Obstacle Notification Bedside Touchscreen is unresponsive Power Outage with guidewire and devices held in tracks by system Suggested Solution(s) 1. Check fluoroscopy image to confirm location of RX device confirm no obstructions. 2. Retract RX device and move it forward. 3. Check for lesion severity or vessel tortuosity that could account for resistance levels outside parameters under which system was designed to operate. 1. Assess at bedside whether guide catheter has been advanced forward such that cassette has reached introducer sheath; if so; no additional forward guide catheter motion is available. Convert to manual if additional guide catheter forward motion is needed 2. If cassette has not reached introducer sheath, remove guide catheter and all devices from cassette. Remove Single-use Cassette. Clean window on Optical Sensor on the Robotic Drive. Re-attach cassette 3. If problem persists, attach new Single-use Cassette. 1. Assess at bedside whether an obstacle is impeding forward motion of the guide catheter. Shift obstacle if possible to remove it from the path of the Robotic Drive. 2. Ensure drape is not taut against the obstacle sensor on the Robotic Drive. Cycle power to bedside unit: 1. Restart Control Console by pressing the Power button at the back of the Control Console, allowing system to shut down, and pressing Power Button again to turn it back on 2. Unplug Extended Reach Arm power (base of arm cable labeled PWR) 3. Wait 30 seconds and plug power cable back in 1. Open cover of Single-use Cassette 2. Ensure linear drive is pinched (linear pinch handle is a 6 o clock position) so that guidewire will not move 3. Press Rotary Drive Release 4. Grasp back portion of cassette (rotary drive), lift slightly and slide it off back of guidewire. 5. Manually rotate linear pinch handle clockwise to 9 o clock position to release guidewire and RX device pinch mechanisms 6. Remove guide catheter and devices from cassette following instructions in Section 8. 73

76 D. System Fault Messages All system faults disable motor drives and suspend system operation. The following codes help provide diagnostic information to Corindus technical support personnel. 74 Figure 10-2: Example of Communications error with fault code Fault Code Descriptions Figure 10-3: CorPath can recover and remember workflow step Title Text Button Fault Code Communications Error Check power cables, data cables, and E-stop button Restart 1001 positions. If problem persists, contact Corindus Technical Support at or Incompatible Software Incompatible software version detected. Contact Shutdown 1002 Corindus Technical Support. GW Drive Motor Error GW drive detected a motor error. If problem Shutdown 1003 persists, contact Corindus Technical Support. BSC Drive Motor Error BSC drive detected a motor error. If problem Shutdown 1004 persists, contact Corindus Technical Support. LP Drive Motor Error LP drive detected a motor error. If problem persists, Shutdown 1005 contact Corindus Technical Support. GWR Drive Motor GWR drive detected a motor error. If problem Shutdown 1006 Error persists, contact Corindus Technical Support. RP Drive Motor Error RP drive detected a motor error. If problem persists, contact Corindus Technical Support. Shutdown 1007

77 Title Text Button Fault Code Robotic Drive Over Robotic Drive detected an over temperature and Shutdown 1008 Temperature should shutdown. If problem persists, contact Control Console Over Temperature Robotic Drive Power Error Control Console Power Error Unintended Motion Unintended Motion Corindus Technical Support. Control Console detected an over temperature and should shutdown. If problem persists, contact Corindus Technical Support. Robotic Drive detected a power error. If problem persists, contact Corindus Technical Support. Control Console detected a power error. If problem persists, contact Corindus Technical Support. Guidewire unintended motion detected. (GW movement was detected without being commanded. If GW was moved manually, restart system to clear fault. If there was no manual movement or fault persists, power off system and call Corindus Technical Support) RX device unintended motion detected. (RX device movement was detected without being commanded. If RX device was moved manually restart system to clear fault. If there was no manual movement or fault persists power off system and call Corindus Technical Support) Shutdown 1009 Shutdown 1010 Shutdown 1011 Shutdown 1012 Shutdown 1013 Motor Obstruction Guidewire motor obstruction detected. Make sure Restart 1014 motor drive is not blocked. Motor Obstruction RX device motor obstruction detected. Make sure Restart 1015 motor drive is not blocked. Motor Obstruction Linear pinch motor obstruction detected. Make sure Restart 1016 motor drive is not blocked. Motor Obstruction Guidewire rotary motor obstruction detected. Make Restart 1017 sure motor drive is not blocked. Unknown Error The cause of the error is unknown. Shutdown 1019 Joint 1 Unexpectedly Arm Joint 1 unlocks unexpectedly. Shutdown 1020 Unlocked Joint 1 Failed to Arm Joint 1 failed to unlock Restart 1021 Unlock Arm Failed to Lock Arm failed to lock Restart 1022 Arm Failed to Unlock Arm failed to unlock Restart 1023 Arm Unexpectedly Arm unlocks unexpectedly. Shutdown 1024 Unlocked GCL Motor Error Guide catheter linear motor error detected. Shutdown GCR Motor Error Guide catheter rotary motor error detected. Shutdown 1026 Motor Obstruction Unintended Motion Guide catheter rotary motor obstruction detected. Make sure the motor drive is not blocked. Guide catheter linear motor unintended motion was detected. Restart 1027 Shutdown 1030

78 Title Text Button Fault Code Motor Obstruction Guide catheter linear motor obstruction detected. Restart 1031 Make sure the motor drive is not blocked. 76 E. Replacement Cassette Errors If operator experiences need for persistent cassette replacements, please contact Corindus Technical Support at or The following codes help provide diagnostic information to Corindus technical support personnel. Title Text Code Replace Cassette Guidewire drive cassette test failed. Remove and replace 3002 cassette. Replace Cassette RX device drive cassette test failed. Remove and replace 3003 cassette. Replace Cassette Linear pinch drive cassette test failed Remove and replace cassette. Replace Cassette Guidewire rotary drive cassette test failed Remove and replace cassette. Replace Cassette Rotational pinch drive cassette test failed Remove and replace cassette. Replace Cassette Cassette error detected. Remove and replace cassette Unpinch RP Cassette error detected. Manually unpinch Rotational Pinch Unpinch LP Cassette error detected. Manually unpinch Linear Pinch 3072 Pinch LP Cassette error detected. Manually pinch Linear Pinch Rotate GWR Cassette error detected. Manually rotate Guidewire rotary 3074 motor. Replace Cassette Guide Catheter rotary drive test failed. Remove and replace cassette Operator may try to remedy above problems through examination of cassette for an obstruction.

79 Appendix A. Technical Specifications 77 Functional Performance Guide Catheter Linear Velocity: 0 to 24 mm/sec Guide Catheter Rotational Velocity: 0 to 90 /sec Guide Catheter Linear Position Error: +-2.5mm Guidewire Linear Velocity: Normal Mode: 0 to 12 mm/sec Turbo Mode: 0 to 60 mm/sec Guidewire Rotational Velocity: Normal Mode: 4 speeds: 45, 90, 180 and 360 /sec RX Device Linear Velocity: Normal Mode: 0 to 12 mm/sec Turbo Mode: 0 to 60 mm/sec Guidewire Linear Position Accuracy: ±0.1 mm using touch-screen keys RX Device Linear Position Accuracy: ±0.1 mm using touch-screen keys Rotational Position Accuracy, Guidewire Only: ±3 using touch-screen keys Linear Measurement Error, Guidewire: ± (10% + 0.1) mm Linear Measurement Error, RX Device: ± (10% + 0.1) mm Physical Characteristics Note: All dimensions are rounded to the nearest inch o o o Control Console: o Dimensions: L= 17, W= 21, H= 9 (43 cm x 53 cm x 23 cm) o Weight: 16.8 lbs (7.6 kg) Bedside Unit (Robotic Drive and Extended Reach Arm): o Dimensions: L= 36, W= 27, H=31 (91 cm x 69 cm x 79 cm) o Weight: 97.2 lbs (44.1 kg) o Note: Dimensions are at lowest 0⁰ loading position o Robotic Drive (Includes portion of Extended Reach Arm permanently attached to Robotic Drive): Dimensions: L= 27, W= 16, H= 10 (69 cm x 41 cm x 25 cm) Weight: 32.6 lbs (14.8 kg) o Extended Reach Arm: (Excluding portion of arm permanently attached to Robotic Drive) Dimensions (lowest storage position): L= 24, W= 22, H=31 (61 cm x 56 cm x 79 cm) Weight: 64.6 lbs (29.3 kg) Single-use Cassette: o Dimensions: L = 21, W = 6, H = 3.2 (L = 53 cm, W=15 cm, H= 8 cm) o Weight: 2.9 lbs (1.3 kg)

80 Environmental Conditions 78 System Operating/Storage Temperature: 15 C to 30 C (59 F to 86 F) Transport Temperature: -18 C to 40 C (-0 F to 104 F) Operating/ Storage/Transport Relative Humidity: Keep dry, protect from moisture Cassette / Single Use Operating/Storage Temperature: 15 C to 30 C (59 F to 86 F) Transport Temperature: -18 C to 40 C (0 F to 104 F) Operating/ Storage/Transport Relative Humidity: Keep dry, protect from moisture Fluid Ingress Protection: Control Console: Standard: IPX1 per IEC Bedside Unit (Robotic Drive + Extended Reach Arm): Standard: IPX2 per IEC 60529

81 Appendix B. Replacement Parts and Consumable Supplies 79 The following system modules, components, and consumable supplies may be ordered for use or replacement in the CorPath GRX System: Durable Modules and Components Item Name Product Description Corindus Part Number CorPath GRX System Complete CorPath GRX System including Interventional cockpit CorPath GRX Control Console CorPath Control Console with Power Supply US configuration CorPath GRX Extended Reach CorPath Extended Reach Arm Arm with Power Supply US Configuration CorPath GRX Robotic Drive CorPath Robotic Drive CorPath Interventional Cockpit, CorPath Interventional Cockpit Standard CorPath GRX system Chair for Chair for Interventional Cockpit Interventional Cockpit CorPath Control Console Power 12V Power Supply with AC Mains Supply Power CorPath Robotic Drive Power Supply 24V Power Supply with AC Mains Power CorPath AC Mains Power Cord- Power Supply-US Configuration CorPath AC Mains Power Cord- Power Supply- OUS Configuration CorPath AC Mains Power Strip- Interventional Cockpit CorPath GRX Communication Cable AC Mains Power Cords for CorPath power supplies-medical Grade-US Configuration AC Mains Power Cords for CorPath power supplies-medical Grade-OUS Configuration AC Mains Power Strip for CorPath Interventional-Cockpit- Medical Grade US Configuration Communication Interface Cable between Control Console and Extended Reach Arm/ Robotic Drive (3 FT) (10 FT) (25 FT) (Denmark) (UK) (Continental EU) (Italy) (Switzerland) (Israel) (6 Meter) (20 Meter) (30 Meter) Note: At the end of their useful life, all durable CorPath GRX System modules and components should be properly disposed of in accordance with local regulations.

82 Consumable Supplies 80 Note: All single-use consumable components for the CorPath GRX System should be treated as hazardous biological waste after use, and properly disposed of in accordance with local regulations. Item Name Product Description Corindus Part Number Shipping Invoice Box of 4 or 5 CorPath GRX Single-use Cassette Single-use Cassette for CorPath GRX System (Ship in box of 4) Corindus UDI Number Box or Pouch of 1 (barcode inventory) CorPath GRX Drive Gear CorPath GRX Robotic Drive Drape Carton of 4 Drive Gears (Ship in a box of 4) Carton of 4 Sterile Drapes for Robotic Drive and Arm (Ship in box of 4) CorPath GRX Control Console Drape Carton of 4 Sterile Drapes for Control Console (Ship in box of 4) CorPath GRX Cockpit Chair Drapes Carton of 5 Sterile Drapes for Interventional Cockpit Chair (Ship in box of 5) Proper Disposal Attention: At the end of their useful life contact Corindus for disposal information.

83 Appendix C. Electromagnetic Compatibility Information 81 Warning: Medical electrical equipment needs special precautions regarding electromagnetic compatibility [EMC] and needs to be installed and put into service according to the EMC information provided in this operator s manual. Warning: Portable and mobile RF communications equipment can affect medical electrical equipment. Warning: The CorPath GRX System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is unavoidable, equipment or system should be observed to verify normal operation in configuration in which it will be used. Warning: Only equipment specified in this operator s manual, and in particular the CorPath GRX System communications cable and power supplies, should be used with the CorPath GRX System. The use of any other equipment may result in increased emissions or decreased immunity of the CorPath GRX System. Note: The EMC tables and other guidelines included in this manual provide information essential for determining the suitability of the CorPath GRX System for the electromagnetic environment of use, and in managing the electromagnetic environment of use to permit the CorPath GRX System to perform its intended use without disturbing other medical equipment and systems or non-medical electrical equipment. IEC : 2005 Table 1 Guidance and Manufacturer s Declaration Emissions The CorPath GRX System is intended for use in the electromagnetic environment specified below. The customer or user of the CorPath GRX System should assure that it is used in such an environment. Emission Test Compliance Electromagnetic-Guidance RF Emissions CISPR11 Group 1 The CorPath GRX System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR11 Harmonics-IEC Class A Class A The CorPath GRX System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Flicker-IEC Complies RF = radio frequency

84 IEC : 2005 Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The CorPath GRX System is intended for use in the electromagnetic environment specified below. The customer or user of the CorPath GRX System should assure that it is used in such an environment. Immunity Test Electrostatic Discharge (ESD)-IEC Electrical Fast Transient/ Burst IEC Surge IEC Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC Power Frequency 50/60Hz Magnetic Field IEC IEC : 2005 Test Level ±6kV contact ±8kV contact ±2kV mains ±1kV for input/ output lines ±1kV differential ±2kV common >95% dip for 0.5 cycle 60% dip for 5 cycles 30% dip for 25 cycles >95% dip for 250 cycles(5 seconds at 50Hz) Non-applicable (no magnetically sensitive devices) Compliance Level ±6kV contact contact ±8kV ±2kV mains 1kV for input/ output lines ±1kV differential ±2kV common >95% dip for 0.5 cycles 60% dip for 5 cycles 30% dip for 25 cycles >95% dip for 250 cycles(5 seconds at 50Hz) Non-applicable (no magnetically sensitive devices) Electromagnetic Environment - Guidance Floors should be wood, concrete, or ceramic tile. If floors are synthetic the relative humidity should be at least 30% Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment. If the operator of the CorPath GRX System requires continued operation during power mains interruptions, it is recommended that the CorPath GRX System be powered from an uninterruptible power supply or battery 82

85 IEC : 2005 Table 4 Guidance and Manufacturer s Declaration Electromagnetic immunity The CorPath GRX System is intended for use in the electromagnetic environment specified below. The customer or user of the CorPath GRX System should ensure that it is used in such an environment. 83 Immunity Test IEC : 2005 Test Level Conducted RF- IEC Vrms150 khz to 80MHz Compliance Level V1= 3Vrms Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be separated from the CorPath GRX System by no less than the recommended separation distances calculated/listed below: D = 1.2 P Radiated RF IEC V/m80MHz to 2.5 GHz E1=3V/m D = 1.2 P 80 to 800MHz D = 2.4 P 800 MHz to 2.5 GHz Where P is the maximum power rating in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter. Note 1: At 80 MHz and 800 MHz the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If measured field strength in location in which the CorPath GRX System is used exceeds applicable RF compliance level above, the CorPath GRX System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CorPath GRX System. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

86 IEC : 2005 Table 6 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CorPath GRX System Equipment and Systems 84 The CorPath GRX System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the CorPath GRX System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the CorPath GRX System as recommended below, according to the maximum output power of the communications equipment. Maximum Output Recommended Separation Distances for the CorPath GRX System Power (Watts) 150 khz to 80 MHz d = 80 to 800MHz d = 800 MHz to 2.5 GHz d 1.2 P 1.2 P = 2.4 P For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

87 Appendix D. Symbol Symbol Descriptions Description Manufactured by 85 Manufacture Date Part number/catalog number Serial number Lot number Expiration date Sterilization method; Sterile via the ethylene oxide sterilization process Do not reuse Caution Emergency Stop (E-stop) Must Consult Operator s Manual Consult Operator s Manual, caution Do not use if package is damaged Keep Dry +40 C Keep Dry System transport temperature limit Cassette/ single use, transport temperature limit

88 Symbol Description Storage temperature limit / Operating temperature limit 86 Type CF Applied Part C = Cardiac F = Floating applied part Stand-by (Power ON and OFF). Identifies the switch by means of which the Control Console is switched on to bring it to an operational condition Turbo speed and directional indication Forward/reverse linear motion Clockwise and counter-clockwise rotational motion of guidewire IPX 1 IPX Classification for protection against vertical drip-proof fluid ingress Classification for protection against angled drip-proof fluid ingress Protection against electrical shock through reliable Protection Earth (PE) and not in basic insulation alone This symbol signifies compliance of the CorPath System with The Medical Device Directive 93/42/EEC Identifies Corindus regulatory representative in the European Community (EC) Not made with natural rubber latex Contains no PVCs Do not re-sterilize Quantity Consult with Corindus Service for Disposal Information only Marking of Conformity to IEC : 3 rd Edition, Amendment series of Standards by Nationally Recognized testing laboratory (NTRL) TUV SUD. Caution federal law restricts this device for sale by or on order of a physician.