Corpath GRX Operator's Manual

CorPath® GRX System Operator’s Manual

CorPath GRX Operator’s Manual

Important Safety Notice to Users of the Corindus CorPath GRX System 1 This manual and the equipment it describes are for use only by qualified medical professionals with adequate training and experience in angiographic procedures and use of the CorPath GRX System. It is intended as a guide for both system components and cassette. It is important that operating instructions and user warnings supplied with the CorPath GRX System be read, understood and followed. Please do not hesitate to contact Corindus if additional training resources are needed.

Patent Information The CorPath GRX system and cassette may be covered by or for use under US patent numbers 6726675; 7615042; 7887549; 8399871; 8480618; 8828021; D626250; D674484; D680645; and D685468; and Non-US patent numbers DE69919851.8, FR/EP 1061990, IL162318, GB/EP 1061990, IE/EP 1061990, IT/EP 1061990, DE/EP 1755727; FR/EP 1755727; GE/EP 1755727; and IT/EP 1755727 and other pending US and Non-US patent applications.

Reproduction of this manual is strictly prohibited without the express written consent of Corindus, Inc. CorPath is a trademark of Corindus

150-07582 Rev C CorPath GRX Operator’s Manual

Section 1. General Information ...... 5 1 Definitions ...... 5 Description ...... 5 A. Indication for Use, Warnings and Precautions ...... 7 Section 2. Clinical Data ...... 8 Section 3. System Description ...... 15 A. CorPath GRX Components ...... 15 B. Control Console ...... 15 C. Touchscreen ...... 16 D. Extended Reach Arm and Robotic Drive ...... 17 E. Single-use Cassette ...... 18 The long white support track, encapsulates and supports the guide catheter ...... 19 Section 4. Software Description...... 20 Section 5. Safety Information ...... 21 A. Emergency Stop Controls ...... 21 B. Electrical Safety ...... 21 C. Electro Magnetic Compatibility (EMC) ...... 23 D. Anesthetics, Oxygen and Fire Hazards ...... 23 E. Sterilization ...... 23 Section 6. CorPath GRX System Installation ...... 24 A. Re-attaching Extended Reach Arm to Procedure Table ...... 24 B. Re-installing the Robotic Drive ...... 25 C. Removing Extended Reach Arm and Robotic Drive from Procedure Table ...... 26 D. Re-connecting Control Console and Bedside Unit ...... 27 Section 7. System Operation ...... 29 A. System Power-up ...... 29 B. Bedside Touchscreen ...... 30 C. Control Console Touchscreen Controls ...... 31 D. Joystick Operation ...... 32 E. Guidewire and Device Speed and Direction Indicators...... 34 F. Discrete Controls ...... 36

150-07582 Rev C CorPath GRX Operator’s Manual

G. Guide Catheter Indicators ...... 37 2 H. CorPath Measurement Function ...... 38 I. Traction Notification ...... 39 J. Pushability Notification ...... 40 K. Obstacle Notification ...... 40 L. Sheath Notification ...... 41 M. Motion Limit Notification ...... 41 N. Extended Reach Arm Controls ...... 42 O. Shutting Down the System ...... 44 Section 8. Performing a Procedure ...... 45 A. Manual Preparations ...... 45 B. Draping the CorPath GRX System ...... 45 C. Preparing Proximal End of Guide Catheter ...... 49 D. Attaching Single-use Cassette ...... 50 E. Positioning Extended Reach Arm for Case ...... 52 F. Loading Guide Catheter ...... 54 G. Loading Guidewire into Single-use Cassette ...... 56 H. Loading Device ...... 58 I. Exchanging a Wire or Device ...... 60 J. Exchanging a Guide Catheter ...... 61 K. Finishing the Case ...... 63

L. Switching to Manual Operation - Power Failure or System Malfunction ...... 66 Section 9. Cleaning, Maintenance and Calibration ...... 68 A. Cleaning ...... 68 B. Maintenance ...... 68 C. Calibration ...... 69 Section 10. Menu ...... 69 Section 11. Troubleshooting ...... 70 A. Problem Solving ...... 70 B. Loading Devices into the System ...... 71 C. Operating the System ...... 72

150-07582 Rev C CorPath GRX Operator’s Manual

D. System Fault Messages ...... 74 3 E. Replacement Cassette Errors ...... 76 Appendix A. Technical Specifications ...... 77 Appendix B. Replacement Parts and Consumable Supplies ...... 79 Appendix C. Electromagnetic Compatibility Information ...... 81 Appendix D. Symbol Descriptions ...... 85

List of Figures Figure 3-1: Control Console Top View ...... 15 Figure 3-2: Control Console Rear Panel ...... 15 Figure 3-3 Control Console Touchscreen Controls ...... 16 Figure 3-4 Robotic Drive and Extended Reach Arm ...... 17 Figure 3-5 Single-Use Cassette...... 18 Figure 5-1: Emergency Stop Buttons ...... 21 Figure 6-1: Mounting Arrangement for Extended Reach Arm ...... 24 Figure 6-2: Mounting Robotic Drive to Extended Reach Arm ...... 25 Figure 6-3: Stowing Bedside Unit ...... 26 Figure 6-4: Push the button left and rotate up to remove ...... 26 Figure 6-5: Cable Connections and Power Button ...... 27 Figure 6-6: Cable Connections to Junction Box ...... 27 Figure 6-7: Interventional Cockpit with Control Console ...... 29 Figure 7-1: Bedside Touchscreen ...... 30 Figure 7-2: Control Console Touchscreen ...... 31 Figure 7-3: Individual Joystick Disable ...... 31 Figure 7-4: Joystick Linear Control Function ...... 32 Figure 7-5: Guidewire & Guide Catheter Joystick Rotational Function ...... 33 Figure 7-6: Guidewire; Speed and Direction Indicators ...... 34 Figure 7-7: Device; Speed and Direction Indicators ...... 35 Figure 7-8: Discrete Controls...... 36 Figure 7-9: Guide Catheter Linear Travel Indicator ...... 37 Figure 7-10: Guide Catheter Rotation Indicator ...... 37 Figure 7-11: Measuring Distance ...... 38 Figure 7-12: Device and Guidewire Measurement Indicators ...... 39 Figure 7-13: Traction Notification ...... 39 Figure 7-14: Pushability Notification ...... 40 Figure 7-15: Obstacle Notification ...... 40 Figure 7-16: Sheath Notification ...... 41 Figure 7-17: Motion Limit Notification ...... 41 Figure 7-18: Extended Reach Arm Joints and Controls ...... 42 Figure 7-19: Minimum Arm Angle ...... 43 Figure 7-20: Fine-tune Controls ...... 43 Figure 7-21: Stowing Bedside Unit ...... 44 Figure 8-1: Minimum exposed Guide Catheter length needed to load into Single-Use Cassette ...... 45

150-07582 Rev C CorPath GRX Operator’s Manual

Figure 8-2: Unfolding Drape ...... 46 Figure 8-3: Lifting Drape ...... 46 4 Figure 8-4: Remove backing from adhesive tabs on faceplate ...... 46 Figure 8-5: Portion of Drape covering Bedside Touchscreen ...... 46 Figure 8-6: Aligning face plate with protrusions on Robotic Drive ...... 47 Figure 8-7: Snapping Drape in place over Track Clamp ...... 47 Figure 8-8: Removing Temporary Face Plate Cover ...... 48 Figure 8-9: Draping Control Console ...... 49 Figure 8-10: Drive Gear and Y-Connector Junction ...... 49 Figure 8-11: Drive Gear and Guide Catheter connection ...... 49 Figure 8-12: Attaching Cassette to Robotic Drive ...... 50 Figure 8-13: Track Clamp connected to Robotic Drive with lever unlocked ...... 50 Figure 8-14 Unclip Support Track and Remove Orange Key ...... 51 Figure 8-16: Cassette test failure, possibly orange key in place...... 51 Figure 8-17: Tilting Robotic Drive Counterclockwise 30 degrees ...... 52 Figure 8-18: Loading Guide Catheter ...... 52 Figure 8-19: Rail Clamp Release Lever ...... 53 Figure 8-20: Robotic Drive, Fine-tune Controls ...... 53 Figure 8-21: Loading Y-Connector...... 54 Figure 8-22: Gently Pull Support Track ...... 54 Figure 8-23: Attaching Support Track to Introducer Sheath ...... 55 Figure 8-24: Locking Track Clamp ...... 55 Figure 8-25: System prompt to prepare to load guidewire ...... 56 Figure 8-26: Tilting Y-Connector Holder ...... 56 Figure 8-27: Placing Guidewire ...... 57 Figure 8-28: Control Console Touchscreen ...... 57 Figure 8-29: Enabled Control Console Touchscreen ...... 58 Figure 8-30: Load/Exchange Devices on Bedside Touchscreen ...... 58 Figure 8-31: System prompt to prepare to load Device ...... 59 Figure 8-32: Anchoring Guidewire ...... 59 Figure 8-33: Loading Device...... 60 Figure 8-34: Placing Device in Single-use Cassette ...... 60 Figure 8-35: Loading Device ...... 61 Figure 8-36: Placing Device ...... 61 Figure 8-37: Bedside Touchscreen ...... 61 Figure 8-38: Removing Guide Catheter ...... 62 Figure 8-39: Ending the Case ...... 63 Figure 8-40: Removing Guide Catheter ...... 63 Figure 8-41: Releasing Cassette ...... 64 Figure 8-42: Allow Robotic Drive to Center ...... 64 Figure 8-43 Level the Robotic Drive ...... 65 Figure 8-44: Stowing Bedside Unit ...... 65 Figure 8-45: Removing Guide Catheter and Unload Devices ...... 66 Figure 8-46: Rotary Drive Release...... 66 Figure 8-47: Removing Rotary Drive ...... 67 Figure 10-1 System Setting Options and System Status ...... 69

150-07582 Rev C CorPath GRX Operator’s Manual

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 percutaneous coronary intervention PVI 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.

150-07582 Rev C CorPath GRX Operator’s Manual

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, 6 one for guidewire manipulation, and a third joystick for guide catheter manipulation.

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

150-07582 Rev C CorPath GRX Operator’s Manual

A. Indication for Use, Warnings and Precautions 7  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.

Contraindications: None known Warnings: 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 intra- arterial 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. Precautions: The CorPath GRX System is recommended for the following device sizes:

 Guidewire: 0.014” diameter  Rapid Exchange Catheter: compatible with 0.014” 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.

150-07582 Rev C CorPath GRX Operator’s Manual

8 Section 2. Clinical Data

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 pre- specified scoring criteria to obtain a subjective assessment from the operator, and 2) intra- procedural 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

150-07582 Rev C CorPath GRX Operator’s Manual

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. 9 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.

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 Success2, n (%) 160/164 (97.6%) 102/104 (98.1%) 101/103 (98.1%) 95% confidence interval3 94.5 94.1 94.0 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 Success4, n (%) 162/164 (98.8%) 102/104 (98.1%) 101/103 (98.1%) 95% confidence interval3 96.2 94.1 94.0

1 Study success is based upon achievement of success in both co-primary endpoints. 2Clinical 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. 3one-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.

150-07582 Rev C CorPath GRX Operator’s Manual

Table 2 – Pre-Procedure Characteristics (Visual Estimates)

ITT* MITT** PP*** (N=103) (N=164) (N=104) Mean ±SD 54.9 ±8.9 55.9 ±7.1 56.0 ±7.1 LVEF measurement (%) Median 55.0 56.0 57.0 Min, Max 30.0, 80.0 30.0, 69.0 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%) 1st 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 13.6 ± 4.0 13.6 ± 4.0 Lesion Length (mm) Median 12.0 12.0 12.0 Min, Max 5.0, 24.0 5.0, 24.0 5.0, 24.0 Mean ±SD 3.0 ± 0.40 3.1 ± 0.43 3.0 ± 0.43 Reference Vessel Diameter Median 3.0 3.0 3.0 (mm) Min, Max 2.5, 4.0 2.5, 4.0 2.5, 4.0 Percent Diameter Stenosis Mean ±SD 78.1 ±10.0 78.0 ±10.2 77.8 ±10.0 (%) Median 80.0 80.0 80.0 Min, Max 50.0, 99.0 50.0, 99.0 50.0, 99.0 0 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 160 103 (99.0%) 102 (99.0%) (97.6%) Mild 157 103 (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 0 (0%) 0 (0%) 0 (0%) (%) No 164 (100%) 104 (100%) 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 Yes 0 (0%) 0 (0%) 0 (0%) lesion, n (%) No 164 (100%) 104 (100%) 103 (100%)

150-07582 Rev C CorPath GRX Operator’s Manual

Table 3 – Procedure Characteristics 11 ITT* (N=164) MITT** PP*** (N=104) (N=103) Number of stents placed 1 152 (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%)

Average number of Mean (SD) 1.1 ±0.34 1.1 ±0.42 1.1 ±0.42 stents placed Median 1.0 1.0 1.0 Min, Max 1,3 1,3 1,3

Geographic miss 1 (7.7%) 1 (8.3%) 1 (8.3%) Reason for additional Plaque shifted 4 (30.8%) 4 (33.3%) 4 (33.3%) stents, n (%)1 Dissection 8 (61.5%) 7 (58.3%) 7 (58.3%) Insufficient lesion 0 (0%) 0 (0%) 0 (0%) coverage Mean (SD) 10.6 ±6.2 9.6 ±4.4 9.6 ±4.4 Fluoroscopy time (min) Median 9.3 8.7 8.4 Min, Max 2.1, 48.0 3.1, 31.5 3.1, 31.5 Mean (SD) 11.1 ±6.2 10.1 ±4.8 10.1 ±4.8 Total x-ray time (min) Median 9.6 9.3 9.3 Min, Max 3.3, 48.0 3.3, 31.5 3.3, 31.5 Mean (SD) 144.2 ±70.4 147.5 ±78.9 148.2 Contrast volume (mL) ±79.0 Median 130.0 130.0 130.0 Min, Max 20.0, 570.0 20.0, 570.0 20.0, 570.0 Subject cumulative dose Mean (SD) 1500.9 ±823.2 1422.6 ±635.3 1429.8 (mGy)2 ±637.8 Median 1323.0 1240.5 1243.0 Min, Max 421.1, 6580 421.1, 3341.9 421.1, 3341.9 Mean (SD) 9944.7±9990.9 10090.9±12241.3 10090.9±1 DAP (cGy*cm2) 2241.3 Median 7658.6 6748.6 6748.6 Min, Max 1298, 80162.0 3516, 80162.0 3516, 80162.0

1 One subject had 2 stents placed due to both a geographic miss and a dissection and therefore is counted in both categories.

150-07582 Rev C CorPath GRX Operator’s Manual

Table 4 – Secondary Safety Endpoints 12 ITT* (N=164) MITT** (N=104) PP*** (N=103) Number (%) of Number (%) of Number (%) of subjects with event subjects with event subjects with event In-hospital MACE1 4 (2.4%) 2 (1.9%) 2 (1.9%) MACE1 at 30-days post- 0 (0.0%) 0 (0.0%) 0 (0.0%) procedure Overall Adverse Event 56 (34.1%) 34 (32.7%) 34 (33.0%) Rate 1 As adjudicated by the CEC

Table 5 – CEC Adjudicated MACE Events

ITT* (N=164) MITT** (N=104) PP*** (N=103) Number (%) of Number (%) of Number (%) of subjects with event subjects with event subjects with event In-hospital MACE¥ (primary 4 (2.4%) 2 (1.9%) 2 (1.9%) endpoint definition) Cardiac Deathɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MIɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MIɸ2 4 (2.4%) 2 (1.9%) 2 (1.9%) TVRɸ3 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 Deathɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MIɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MIɸ2 2 (1.2%) 1 (0.96%) 1 (0.96%) TVRɸ3 0 (0.0%) 0 (0.0%) 0 (0.0%) MACE at 30 days FU 0 (0.0%) 0 (0.0%) 0 (0.0%) Cardiac Deathɸ 0 (0.0%) 0 (0.0%) 0 (0.0%) Q-wave MIɸ1 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-wave MIɸ2 0 (0.0%) 0 (0.0%) 0 (0.0%) TVRɸ3 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. ɸCardiac 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: ɸ1Q 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. ɸ2Non-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. ɸ3TVR –Target Vessel Revascularization-defined as ischemia-driven repeat PCI of the target vessel or bypass surgery of the target vessel.

150-07582 Rev C CorPath GRX Operator’s Manual

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%)

150-07582 Rev C CorPath GRX Operator’s Manual

Rapid Study 14 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.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Section 3. System Description 15 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 B. Control Console

Touchscreen

Emergency Stop

Turbo Button Guide Catheter Joystick

RX Device Joystick Guidewire Joystick

Figure 3-1: Control Console Top View Control Console Components Power On/Off Button Located in back of the console, turns power on and off to the console Turbo Button Increases advancement or retraction speed of guidewire and RX device by 5x Turbo mode is not available for the guide catheter. RX Device Joystick Advances and retracts the RX device when enabled Guidewire Joystick Advances, retracts, and rotates guidewire when enabled Guide Catheter Joystick Advances, retracts, and rotates guide catheter when enabled Active Joystick LEDs 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. E-Stop (Emergency Stop) Disables power to Robotic Drive. Use in event of emergency only

Control Console Power On/Off Button

Figure 3-2: Control Console Rear Panel

150-07582 Rev C CorPath GRX Operator’s Manual

C. Touchscreen 16

Enable/Disable All Icon Guide Catheter Enable/Disable Distance each Icon Indicator Individually Rotation Indicator Measurement Indicators Linear Travel Indicator 1 mm 1 mm Advance and Retract Advance and Retract

Speed Indicators 30° Wire Rotation Controls 3-3 Control Console Touchscreen Controls

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 joystick and Touchscreen functions. RX Device and Guidewire The window displays movements of RX device and guidewire in mm. Touching Measurement Indicators the “Save” button saves the number displayed above the “Reset” button. Touching “Reset” button sets indicator to “0” 1 mm Advance and The 1mm icon advances and retracts RX device, guidewire, or guide catheter in 1 Retract 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 The window displays guide catheter travel movement. “+” indicates advance, “-” Indicator indicates retract. Touching “Reset” button sets indicator to “0” Guide Catheter Linear The ruler displays linear travel distance available to advance and retract guide Travel Indicator 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. Guide Catheter Rotation The indicator displays degrees rotation of guide catheter. “+” is clockwise, “-” is Indicator counterclockwise. Touching “Reset” button sets indicator to “0”. The arrow indicates rotation direction. Color brightens with increasing number of revolutions in one direction

150-07582 Rev C CorPath GRX Operator’s Manual

D. Extended Reach Arm and Robotic Drive Emergency -Stop Extended Reach Arm 17 Power Indicator Optical Sensor Track Clamp Holder

Bedside Touchscreen Emergency Arm Release

Obstacle Sensor Robotic Drive Handle Arm Unlock Button

Fine-tune Controls

Robotic Drive

Bed Support

Rail Clamp Rail Clamp Release Lever

Figure 3-4 Robotic Drive and Extended Reach Arm

Robotic Drive Components Bedside Touchscreen The interface tool for bedside operator during system set-up, loading and exchanges Power Indicator The light indicates power connected to the bedside unit E-Stop (Emergency Stop) E-Stop disables power to Robotic Drive. Use in event of emergency only Fine-Tune Controls Use to fine-tune location of the Robotic Drive if needed before loading guide catheter onto the cassette Track Clamp Holder The track clamp holder attaches to Track Clamp on Single-use Cassette Arm Unlock Button 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.

150-07582 Rev C CorPath GRX Operator’s Manual

E. Single-use Cassette 18 Locking Lever Linear Pinch Handle

Track Clamp

Guide Catheter Track

Aux. Device Holder Rotational Gate

Linear Gate

Orange Key

Aux. Device Path Auxiliary Device Holder Button

Y-Connector Holder Sheath Retainer

Wire Holder

Y-Connector Drive Gear

Rotary Drive Release Figure 3-5 Single-Use Cassette

150-07582 Rev C CorPath GRX Operator’s Manual

19 Single-use Cassette Components Y-Connector Holder Holds the Y-Connector in place

Guide Catheter Support Track The long white support track, encapsulates and supports the guide catheter Track Clamp 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 Sheath Retainer The plastic sheath retainer connects Guide Catheter Support Track to introducer sheath Drive Gear White gear connector between guide catheter and Y-Connector that enables rotation of guide catheter Rotational Gate Captures guidewire in Rotary Track Linear Gate Captures guidewire and RX device in Linear Drive Track Auxiliary Device Path 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 Auxiliary Device Holder Feature inside Auxiliary Device Path to help user to hold one auxiliary device in place within the Single-use Cassette Auxiliary Device Holder When pressed, button opens Auxiliary Device Holder to allow placement of a Button device inside the holder Linear Pinch Handle Enables removal of PCI / PVI devices, in the event of power loss, via manual turn Orange Key The orange key secures Rotary Drive during shipment Wire Holder Fixates guidewire when introducing the RX device Rotary Drive Release 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

150-07582 Rev C CorPath GRX Operator’s Manual

Section 4. Software Description 20 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.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Section 5. Safety Information 21 This section includes important safety-related information. Please review this section carefully before the operating the system. 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 60601-1:2005/AMD1:2012, ed 3.1, including national/regional version:

 ANSI/AAMI ES60601-1:2005 & A1:2012; US differences  CAN/CSA-C22.2 NO. 60601-1:14, Canadian differences  EN 60601-1:2006/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 60529.

150-07582 Rev C CorPath GRX Operator’s Manual

Warning: No modification of this equipment or system is allowed. 22 Caution: The equipment uses a medical grade power supply to isolate equipment from the supply mains.

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 800.605.9635 or 508.653.3335.

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 Corindus Power Supply Used Output Mains Input Subsystem Part Voltage/Power Voltage/Frequency/Power Number

Control 110-05908 XP Power 12VDC/ 165W 100-240VAC/50-60-HZ/ Console 140W (model # AHM180PS12)

Robotic Drive 111-03785 International Components, 24VDC/ 150W 100-240VAC/50-60Hz/ Inc. (model # 06- 165W 5MWA150024A-12A )

150-07582 Rev C CorPath GRX Operator’s Manual

C. Electro Magnetic Compatibility (EMC) 23 The CorPath GRX System has been tested and found to be in compliance with International Standard IEC 60601-1: 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. 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 re- sterilization. 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.

150-07582 Rev C CorPath GRX Operator’s Manual

Section 6. CorPath GRX System Installation 24 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. 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).

Bed Support

Release Lever

Rail Clamp

Figure 6-1: Mounting Arrangement for Extended Reach Arm

150-07582 Rev C CorPath GRX Operator’s Manual

The Extended Reach Arm is designed to be positioned in this location such that it will not need to be 25 moved on the rail to reach the intended access site for the majority of patients.

1. 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

150-07582 Rev C CorPath GRX Operator’s Manual

C. Removing Extended Reach Arm and Robotic Drive from Procedure Table 26 Ensure the Extended Reach Arm is in the stowage position (See Figure 6-3)

Joint 2 Joint 3

Figure 6-3: Stowing Bedside Unit

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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. 27 9. Store the system in a secure location to prevent damage. 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

150-07582 Rev C CorPath GRX Operator’s Manual

1. Connect the 24V Power Supply cable to the connector on the left-hand side of back of Extended Reach Arm. 28

2. 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 60601-1 (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.

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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 set- up, loading, and device exchanges. (See Figure 7-1)

When the Bedside functions are active (enabled), Control Console functions are disabled.

150-07582 Rev C CorPath GRX Operator’s Manual

C. Control Console Touchscreen Controls 31

Shows drive controls enabled and displays feedback of Shows drive controls disabled and allows operator to those controls when operator activates them activate controls via “Enable All” function Figure 7-2: Control Console Touchscreen 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.

150-07582 Rev C CorPath GRX Operator’s Manual

D. Joystick Operation 32 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.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Rotating Guidewire and Guide Catheter: 33 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)

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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 After 2 revolutions 360 degrees + 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.

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

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.

Figure 7-12: Device and Guidewire Measurement Indicators

I. Traction Notification

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

N. Extended Reach Arm Controls 42 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)

Joint #2 (Friction Joint) Arm-to-Robotic Drive Attachment Joint #4 Mast Joint #1 Joint #3 Robotic Drive Pitch Angle

Emergency Arm Release

Fine-tune Arm Unlock Button Controls

Rail Clamp Release Lever

Figure 7-18: Extended Reach Arm Joints and Controls 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.

150-07582 Rev C CorPath GRX Operator’s Manual

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 43 Touchscreen: (See Figure 7-19)

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

150-07582 Rev C CorPath GRX Operator’s Manual

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".

150-07582 Rev C CorPath GRX Operator’s Manual

Section 8. Performing a Procedure 45 A. Manual Preparations The operator must manually perform the following:

 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).

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

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. 47 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)

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

150-07582 Rev C CorPath GRX Operator’s Manual

field is completely covered. 48 10. Remove the temporary face plate cover before attaching Single-use Cassette. (See Figure 8-8)

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

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]

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

Figure 8-16: Tilting Robotic Drive Counterclockwise 30 degrees 52 E. Positioning Extended Reach Arm for Case

1. 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 8-18.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Figure 8-18: Rail Clamp Release Lever 53 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.

3. 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

150-07582 Rev C CorPath GRX Operator’s Manual

F. Loading Guide Catheter 54 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.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

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 55 rotate the white proximal end of the sheath retainer towards user as shown in Figure 8-22. The white retainer has friction spots to ensure sheath retention for a secure support track.

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

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

Figure 8-26: Placing Guidewire

6. Close the cassette cover and gates.

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 Shows drive controls enabled and displays feedback of activate controls via “Enable All” function those controls when operator activates them

Figure 8-27: Control Console Touchscreen

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

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)

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

2. Turn the Track Clamp counter clockwise to unlocked position (See Figure 8-37: [Arrow #1]. 62 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.

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

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

3. Disconnect the sheath retainer from the introducer sheath, and pull the support track back into Single- use Cassette by pulling proximal end of the support track. (See Figure 8-39) [Arrow 2] 64 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]

Figure 8-40: Releasing Cassette 13. Discard the Single-use Cassette. 14. Remove and discard the sterile drapes. 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 8-41. (Ready to stow or new case)

Figure 8-41: Allow Robotic Drive to Center

150-07582 Rev C CorPath GRX Operator’s Manual

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

150-07582 Rev C CorPath GRX Operator’s Manual

L. Switching to Manual Operation - Power Failure or System Malfunction 66 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.

1. 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

150-07582 Rev C CorPath GRX Operator’s Manual

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Section 9. Cleaning, Maintenance and Calibration 68 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.

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: 800.605.9635 or 508.653.3335.

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.

150-07582 Rev C CorPath GRX Operator’s Manual

Corindus recommends a periodic system preventive maintenance process, performed by Corindus, to maintain CorPath GRX System performance. Corindus also recommends periodic inspections of cabling 69 and connectors for handling damage. 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 800.605.9635 or 508.653.3335.

System Settings and System Status in Menu

Figure 10-1 System Setting Options and System Status

150-07582 Rev C CorPath GRX Operator’s Manual

Section 11. Troubleshooting 70

A. Problem Solving Problem Descriptions

Problem Description Suggested Solution(s) Trouble sliding Extended Reach Arm on bed 1. Ensure arm is not extended. Arm should be in stowage rail position for easiest sliding on rail 2. Push on Rail Clamp Release Lever Unable to position Extended Reach Arm 1. Ensure arm is mounted on the recommended portion correctly for case 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).

Unable to attach Single-use Cassette to 1. Check the drape to make sure it is properly positioned Robotic Drive 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. Unable to attach Track Clamp to Robotic 1. Ensure that cassette is properly attached, and that tab Drive 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. Unable to collapse Extended Reach Arm into Before attempting to stow the arm, push down on the Stowage Position Robotic Drive such that it is below the marking indicated on the mast

150-07582 Rev C CorPath GRX Operator’s Manual

B. Loading Devices into the System 71 Problem Description Suggested Solution(s) Difficulty loading guide catheter into Single- 1. Pull flexible support track back into the cassette use 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) Difficulty loading guidewire into Single-use 1. Repeat loading process, ensuring the Linear Pinch Cassette 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. Difficulty loading Device into Single-use 1. Repeat loading process, ensuring the Linear Pinch Cassette 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.

150-07582 Rev C CorPath GRX Operator’s Manual

C. Operating the System 72 Problem Description Suggested Solution(s) Joysticks do not respond to user 1. Ensure Control Console is enabled input. 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 800.605.9635 or 508.653.3335 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 Touchscreen controls to 1. Ensure Control Console is enabled manipulate guide catheter, 2. Check for lesion severity or vessel tortuosity that could account guidewire or ` do not respond to for resistance levels outside parameters under which system user inputs. was designed to operate. Difficulty advancing, retracting, or 1. Ensure Drive Gear is properly attached rotating Guide Catheter 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. Repeated Traction Notification on 1. Retract guidewire 10 to 20 mm Guidewire 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. Repeated Traction Notification on 1. Retract RX device 10 to 20 mm. Device 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. Repeated Pushability Notification 1. Check fluoroscopy image to confirm location of guidewire and on Guidewire 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.

150-07582 Rev C CorPath GRX Operator’s Manual

Problem Description Suggested Solution(s) Repeated Pushability Notification 1. Check fluoroscopy image to confirm location of RX device 73 on 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. Repeated Sheath Notification 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. Repeated Obstacle Notification 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. Bedside Touchscreen is Cycle power to bedside unit: unresponsive 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 Power Outage with guidewire and 1. Open cover of Single-use Cassette devices held in tracks by system 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.

150-07582 Rev C CorPath GRX Operator’s Manual

D. System Fault Messages 74 All system faults disable motor drives and suspend system operation. The following codes help provide diagnostic information to Corindus technical support personnel.

Figure 10 -2: Example of Communications error with fault code

Figure 10 -3: CorPath can recover and remember workflow step Fault Code Descriptions 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 800.605.9635 or 508.653.3335. 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, Shutdown 1007 contact Corindus Technical Support.

150-07582 Rev C CorPath GRX Operator’s Manual

Title Text Button Fault Code Robotic Drive Over Robotic Drive detected an over temperature and Shutdown 1008 75 Temperature should shutdown. If problem persists, contact Corindus Technical Support. Control Console Over Control Console detected an over temperature and Shutdown 1009 Temperature should shutdown. If problem persists, contact Corindus Technical Support. Robotic Drive Power Robotic Drive detected a power error. If problem Shutdown 1010 Error persists, contact Corindus Technical Support. Control Console Power Control Console detected a power error. If problem Shutdown 1011 Error persists, contact Corindus Technical Support. Unintended Motion Guidewire unintended motion detected. Shutdown 1012 (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) Unintended Motion RX device unintended motion detected. Shutdown 1013 (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) 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 1025

GCR Motor Error Guide catheter rotary motor error detected. Shutdown 1026

Motor Obstruction Guide catheter rotary motor obstruction detected. Restart 1027 Make sure the motor drive is not blocked. Unintended Motion Guide catheter linear motor unintended motion was Shutdown 1030 detected.

150-07582 Rev C CorPath GRX Operator’s Manual

Title Text Button Fault Code Motor Obstruction Guide catheter linear motor obstruction detected. Restart 1031 76 Make sure the motor drive is not blocked.

E. Replacement Cassette Errors If operator experiences need for persistent cassette replacements, please contact Corindus Technical Support at 800.605.9635 or 508.653.3335. 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. 3004 Remove and replace cassette. Replace Cassette Guidewire rotary drive cassette test failed. 3005 Remove and replace cassette. Replace Cassette Rotational pinch drive cassette test failed. 3006 Remove and replace cassette. Replace Cassette Cassette error detected. Remove and replace cassette. 3042 Unpinch RP Cassette error detected. Manually unpinch Rotational Pinch. 3071 Unpinch LP Cassette error detected. Manually unpinch Linear Pinch 3072 Pinch LP Cassette error detected. Manually pinch Linear Pinch. 3073 Rotate GWR Cassette error detected. Manually rotate Guidewire rotary 3074 motor. Replace Cassette Guide Catheter rotary drive test failed. Remove and replace 3076 cassette.

Operator may try to remedy above problems through examination of cassette for an obstruction.

150-07582 Rev C CorPath GRX Operator’s Manual

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 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)

o 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)

o 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)

150-07582 Rev C CorPath GRX Operator’s Manual

78 Environmental Conditions

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 60529  Bedside Unit (Robotic Drive + Extended Reach Arm): Standard: IPX2 per IEC 60529

150-07582 Rev C CorPath GRX Operator’s Manual

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 160-01857 including Interventional cockpit CorPath GRX Control Console CorPath Control Console with 081628002301 Power Supply—US configuration CorPath GRX Extended Reach CorPath Extended Reach Arm 081628002302 Arm with Power Supply—US Configuration CorPath GRX Robotic Drive CorPath Robotic Drive 081628002303 CorPath Interventional Cockpit, CorPath Interventional Cockpit 081628002101 Standard CorPath GRX system Chair for Chair for Interventional Cockpit 160-01458 Interventional Cockpit CorPath Control Console Power 12V Power Supply with AC Mains 110-05908 Supply Power CorPath Robotic Drive Power 24V Power Supply with AC Mains 111-03785 Supply Power CorPath AC Mains Power Cord- AC Mains Power Cords for 110-01068-08 (3 FT) Power Supply-US Configuration CorPath power supplies-Medical 110-01068-01 (10 FT) Grade-US Configuration 110-01068-24 (25 FT) CorPath AC Mains Power Cord- AC Mains Power Cords for 110-01068-02 (Denmark) Power Supply- OUS CorPath power supplies-Medical 110-01068-03 (UK) Configuration Grade-OUS Configuration 110-01068-04 (Continental EU) 110-01068-05 (Italy) 110-01068-06 (Switzerland) 110-01068-07 (Israel) CorPath AC Mains Power Strip- AC Mains Power Strip for 110-00993-01 Interventional Cockpit CorPath Interventional-Cockpit- Medical Grade—US Configuration CorPath GRX Communication Communication Interface Cable 110-03783-01 (6 Meter) Cable between Control Console and 110-03783-02 (20 Meter) Extended Reach Arm/ Robotic 110-03783-03 (30 Meter) Drive

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.

150-07582 Rev C CorPath GRX Operator’s Manual

80 Consumable Supplies

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 Corindus UDI Number Shipping – Box or Pouch of 1 Invoice Box of 4 or 5 (barcode – inventory) CorPath GRX Single-use Single-use Cassette for 081628002305 081628002304 Cassette CorPath GRX System (Ship in box of 4)

CorPath GRX Drive Gear Carton of 4 Drive Gears 081628002307 081628002306 (Ship in a box of 4) CorPath GRX Robotic Carton of 4 Sterile Drapes 081628002309 081628002308 Drive Drape for Robotic Drive and Arm (Ship in box of 4)

CorPath GRX Control Carton of 4 Sterile Drapes 081628002311 081628002310 Console Drape for Control Console (Ship in box of 4)

CorPath GRX Cockpit Carton of 5 Sterile Drapes 074842605318 074842605319 Chair 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.

150-07582 Rev C CorPath GRX Operator’s Manual

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 60601-1: 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 Class A The CorPath GRX System is suitable for use in all establishments other than domestic and those directly Harmonics-IEC61000-3-2 Class A connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Flicker-IEC61000-3-3 Complies RF = radio frequency

150-07582 Rev C CorPath GRX Operator’s Manual

82 IEC 60601-1: 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 IEC 60601 -1: 2005 Test Compliance Level Electromagnetic Level Environment - Guidance Electrostatic Discharge ±6kV contact ±8kV ±6kV contact ±8kV Floors should be wood, (ESD)-IEC61000-4-2 contact contact concrete, or ceramic tile. If floors are synthetic the relative humidity should be at least 30% Electrical Fast ±2kV mains ±1kV ±2kV mains Mains power quality Transient/ Burst — for input/ output lines 1kV for input/ output should be that of a IEC 61000-4-4 lines typical commercial or hospital environment Surge — ±1kV differential ±2kV ±1kV differential ±2kV Mains power quality IEC 61000-4-5 common common should be that of a typical commercial or hospital environment Voltage Dips, Short >95% dip for 0.5 cycle >95% dip for 0.5 cycles Mains power quality Interruptions and 60% dip for 5 cycles 60% dip for 5 cycles should be that of a Voltage Variations on 30% dip for 25 cycles 30% dip for 25 cycles typical commercial or Power Supply Input >95% dip for 250 >95% dip for 250 hospital environment. If Lines — cycles(5 seconds at cycles(5 seconds at the operator of the IEC 61000-4-11 50Hz) 50Hz) 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 Power Frequency Non-applicable (no Non-applicable (no 50/60Hz Magnetic Field magnetically sensitive magnetically sensitive IEC 61000-4-8 devices) devices)

150-07582 Rev C CorPath GRX Operator’s Manual

IEC 60601-1: 2005 Table 4 Guidance and Manufacturer’s Declaration— Electromagnetic immunity 83 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.

Immunity Test IEC 60601-1: Compliance Electromagnetic Environment - Guidance 2005 Test Level Level 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

Conducted RF- 3 Vrms150 kHz to V1= 3Vrms

IEC 61000-4-6 80MHz

D = 1.2 √ P 80 to 800MHz 3V/m80MHz to D = 2.4 √ P 800 MHz to 2.5 GHz Radiated RF – 2.5 GHz E1=3V/m Where P is the maximum power rating in watts and IEC 61000-4-3 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.

150-07582 Rev C CorPath GRX Operator’s Manual

IEC 60601-1: 2005 Table 6 Recommended Separation Distances Between Portable and Mobile RF 84 Communications Equipment and the CorPath GRX System Equipment and Systems

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 0.01 0.12 0.12 0.24 0.1 0.37 0.37 0.74 1 1.2 1.2 2.4 10 3.7 3.7 7.4 100 12 12 24 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.

150-07582 Rev C CorPath GRX Operator’s Manual

Appendix D. Symbol Descriptions 85 Symbol Description Manufactured by

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

Keep Dry System transport temperature limit + 40C

Cassette/ single use, transport temperature limit

150-07582 Rev C CorPath GRX Operator’s Manual

Symbol Description 86 Storage temperature limit / Operating temperature limit

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

Classification for protection against vertical drip-proof fluid ingress IPX 1 IPX 2 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 0086 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

Marking of Conformity to IEC60601-1: 3rd Edition, Amendment 1 2005 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. ℞only

150-07582 Rev C CorPath GRX Operator’s Manual

87 Notes

150-07582 Rev C