1. OverviewIndication for use: The CorPath GRX System is intended for use in the remote delivery

and manipulation of coronary guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary interventional (PCI) procedures.

Contraindications: None known.

Warnings: The CorPath GRX System should only be used by qualified personnel familiar with PCI 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 PCI devices should not be moved with CorPath GRX System without fluoroscopic visualization.

The turbo function should not be used when the guidewire or device is intra-arterial. The turbo function must only be used when the guidewire and 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.

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 GRX System. After use, properly discard the Single-use Cassette 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.

Precautions: The CorPath GRX System has not been evaluated in chronic total occlusions (CTOs), ostial lesions, and moderately to severely calcified lesions. The CorPath GRX System should only be used with 0.014” guidewires and rapid exchange balloon/stent catheters.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 is recommended for use with guide catheter sizes 5 – 7 F.

CorPath® GRX SystemSingle – Use Cassette

Instructions for Use

13. If after manual movement of Extended Reach Arm, Y-Connector is still not well-aligned with Y-Connector Holder, use Robotic Drive Fine-tune Controls to fine-tune location of Robotic Drive before loading guide catheter onto cassette. 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 guide catheter and devices are NOT loaded onto the Single-use Cassette when using Fine-tune Controls

14. Position 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 guide catheter so that it is inside slot at distal end of the cassette16. Close lid of Y-Connector Holder.17. Gently pull Guide Catheter Track out from cassette, so that it completely

encapsulates guide catheter. 18. Hold onto the introducer sheath to ensure guide catheter and sheath do not move.

Attach track to introducer sheath by capturing the sheath port in the sheath retainer, and rotating proximal end of the sheath retainer towards user.

19. Turn lever on Track Clamp clockwise 180 degrees so that it is in locked position20. .13. Finishing the Case

1. Press “End Case” on Bedside Touchscreen

2. Turn Track Clamp counter clockwise to unlocked position [Figure 13-2, Arrow #1].

3. Disconnect sheath retainer from introducer sheath, and pull track back into Single-Used Cassette by pulling proximal end of track. Figure 13-1: Ending the Case

4. If guidewire or devices are still loaded onto cassette, open cassette cover and gates, and lift guidewire and devices out of their tracks. Using standard PCI technique, remove balloon/stent catheter and guidewire from guide catheter

5. Open lid on Y-Connector Holder [Figure 13-2, Arrow #4] and lift Y-Connector and guide catheter out of Single-use Cassette

Figure 13-2: Removing Guide Catheter

12. Exchanging a Guide Catheter 1. Press “Exchange Guide” on Bedside Touchscreen2. Turn Track Clamp counterclockwise to unlocked position [Figure 12-2, Arrow #1]3. Disconnect sheath retainer from introducer sheath, by rotating proximal end of

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 track back into Single-use Cassette [Figure 12-2, Arrow #3] by pulling proximal end of track. Ensure track is fully re-inserted into cassette.

Figure 12-1: Bedside Touchscreen

Figure 12-2: Removing Guide Catheter

Caution: Hold introducer sheath while disconnecting sheath retainer to ensure sheath is not inadvertently moved. Hold guide catheter while moving track to ensure guide does not move.

5. If guidewire or devices are still loaded onto cassette, open cover and gates and lift guidewire and devices out of their tracks. Using standard PCI technique, remove balloon/stent catheter and guidewire from guide catheter.

6. Open lid on Y-Connector Holder [Figure 12-2, Arrow #4] and lift Y-Connector and guide catheter out of Single-use Cassette.

7. Manually remove guide catheter from patient according to standard PCI technique.8. Detach distal end of Drive Gear from previous guide catheter.9. Attach distal end of Drive Gear with Y-Connector to new guide catheter.10. After manually engaging coronary ostium with new guide catheter, prepare to load

new guide catheter onto Single-use Cassette.11. Open lid of Y-Connector Holder.12. If needed, unlock Extended Reach Arm and position Robotic Drive such that

Y-Connector reaches cassette Y-Connector Holder comfortably, without the guide catheter being tugged, or hanging with excess slack

Caution: Tugging on guide catheter during system set-up can result in unintended motion at distal end of guide catheter. Exercise caution and maintain guide catheter steady when loading.

15. Single-use Cassette Components

6. Lift guidewire and balloon/stent catheter out of their tracks. 7. Manually remove guide catheter from patient according to standard PCI technique8. Lift Y-Connector out of cassette and complete procedure according to standard PCI

technique9. Close cassette covers and gates10. Move Extended Reach Arm away from patient.11. After all devices are unloaded from cassette, press “Release Cassette” on Bedside

Touchscreen.12. When prompted by system, push and hold Cassette Release Button [Figure 13-3,

Arrow #1] and remove Single-use Cassette from Robotic Drive [Arrow #2].

Figure 13-3: Releasing the Cassette

13. Discard Single-use Cassette.14. Follow system prompts to level the Robotic Drive such that it is no longer tilted.15. Remove and discard sterile drapes16. System will notify user that Robotic Drive is moving to Cassette Attachment

Position. Clear area and enter “Allow” on Bedside Touchscreen.Caution: Ensure all devices are removed from cassette before entering “Allow”

17. To place 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. (See Figure 13-4). Angle Friction Joint to position Robotic Drive. (See Figure 13-4).

Figure 13-4: Stowing Extended Reach Arm

ng Extended Reach Arm 14. Switching to Manual Operation - Power Failure or System Malfunction

Note: To switch to manual operation when system has power, see instructions for “Finishing the Case.” The instructions listed below assume there has been 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 [Figure 14-1, Arrow #1]

Figure 14-1: Removing Guide Catheter

Caution: Hold introducer sheath while disconnecting sheath retainer to ensure sheath is not inadvertently moved. Hold guide catheter while moving track to ensure guide does not move.

2. Disconnect sheath retainer from introducer sheath [Figure 14-1, Arrow #2]. 3. Pull track back into Single-use Cassette by pulling proximal end of track. Ensure track

is fully re-inserted into cassette [Figure 14-1, Arrow #3].4. Open Y-connector holder [Figure 14-1, Arrow #4]5. Open Single-use Cassette cover [Figure 14-1, Arrow #5].6. Ensure Linear Drive is pinched; (Linear Pinch Handle is a 6 o’clock position) then

guidewire will not move.7. Press Rotary Drive Release. (See Figure 14-2).

Figure 14-2: Opening Gate Release

8. While continuiing to press the Rotatary Drive Release, grasp back portion of cassette (Rotary Drive), lift slightly and slide it off back of guidewire. (See Figure 14-3).

Figure 14-3: Removing Rotary Drive

9. Manually rotate Linear Pinch Handle clockwise to 9 o’clock position to release guidewire and balloon/stent catheter pinch mechanisms.

Caution: Hold guidewire and/or balloon/stent catheter steady to avoid inadvertent movement in patient

10. Open Linear Gate.11. Lift guidewire and balloon/stent catheter (if present) out of their tracks. Open

Y-Connector Holder and lift Y-Connector and guide catheter out of Single-use Cassette.

12. Pull the emergency arm release lever and move Extended Reach Arm out of the way.

13. Continue procedure manually.

Symbol Description

Manufactured by

Part number/Catalog number

Lot number

Expiration date

Sterilization method; Sterile via the ethylene oxide sterilization process

Do not reuse

Consult accompanying Documentation

Emergency Stop (E-stop)

Must Consult Operator’s Manual

Consult Operator’s Manual, caution

Do not use if package is damaged

Keep Dry

Cassette/ single use, transport temperature limit

Storage temperature limit

Type CF Applied Part C = CardiacF = 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

Protection against electrical shock through reliableProtection Earth (PE) and not in basic insulation alone

CE Mark

Identifies Corindus regulatory representative in the European Community (EC)

Not made with natural rubber latex

Contains no PVCs

Do not re-sterilize

Quantity

Marking of Conformity to IEC60601-1: 3rd Edition, 2005 series of Standards by Nationally Recognized testing laboratory (NTRL) TUV SUD.

℞onlyCaution federal law restricts this device for sale by or on order of a physician.

℞onlyCorindus, Inc.309 Waverley Oaks Road • Suite 105Waltham, MA 02452 U.S.A.Phone 800.605.9635 or 508.653.3335Fax (508) 653-3355 info@corindus.com • www.corindus.com

EU Authorized RepresentativeMDSS GmbHSchiffgraben 413017 Hannover, Germany

150 - 04992 Rev A

309 Waverley Oaks Road, Suite 105 Waltham, MA 02452

3. Lift lever on Y-Connector Holder to tilt Y-Connector Holder upward for improved access

Caution: Guidewire is no longer fixed by system. Ensure that guidewire position is maintained by manually holding guidewire, or by anchoring it in Wire Holder during loading of balloon/stent catheter. Take care not to damage the guidewire when inserting it in the Wire Holder. (See Figure 10-3). Figure 10-3: Anchoring guidwire

Figure 10-4: Loading Balloon/Stent Catheter

4. Use standard PCI technique to load balloon/stent catheter onto guidewire until catheter is advanced into Y-Connector past its coaxial portion and to first marker. (See Figure 10-4).

5. Gently remove guidewire from Wire Holder and compress levers on Y-Connector Holder to tilt the Y-Connector downward until it clicks into place. Fit guidewire into guidewire track and balloon/stent catheter into device track. (See Figure 10-5).

Figure 10-5: Placing Balloon/Stent Catheter in Single-Use Cassette

6. Close cassette cover and gates.7. Touch “Enable All” icon on Control Console to activate joysticks and Touchscreen.

Shows drive controls enabled and displays feedback of those controls when operator

activates them

Shows drive controls disabled and allows operator to activate controls via “Enable

All” function

8. Use joysticks and/or Touchscreen controls to navigate guidewire to target location.

Figure 9-5: Enabled Control Console Touchscreen

10. Loading Balloon/Stent Catheter

Press “Load/Exchange Devices” on beside Touchscreen. (See Figure 10-1).

Figure 10-1: Load/Exchange Devices on Bedside Touchscreen

1. When prompted by system, open cassette cover, Rotary Gate and Linear Gate. (See Figure 10-2)

2. Lift guidewire from wire track.

Figure 10-2: System Prompt to prepare to load balloon/stent catheter

Caution: System will rotate Linear Pinch Handle to allow loading/unloading of 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 Y-Connector Holder to tilt Y-Connector Holder upward for improved access

Figure 9-2: Tilting Y-Connector Holder

3. Insert guidewire through a guidewire introducer and into Y-Connector. Advance guidewire a short distance until floppy portion of wire is inside guide catheter. Remove wire introducer.

Note: Operator may load balloon/stent catheter on guidewire at this point, provided they know which type of device will be used. See instructions in section titled “Loading Balloon/Stent Catheter”.

4. Compress levers on Y-Connector Holder and tilt Y-Connector Holder downward until it clicks in place.

5. Gently maneuver guidewire into guidewire track.

6. Close cassette cover and gates. Figure 9-3: Placing Guidewire

Warning: Do NOT move Extended Reach Arm or Robotic Drive when guide catheter, guidewire, or device(s) are loaded onto Single-use Cassette.

7. Touch “Enable All” icon on Control Console to activate joysticks and Touchscreen. Touchscreen controls will become visible on the screen. (See Figure 9-4).

Figure 9-4: Control Console Touchscreen

Fig 8-2: Attaching Track to Introducer SheathCaution: Monitor access site throughout setup and procedure to ensure introducer sheath and guide catheter are not inadvertently moved.

8. Turn lever on Track Clamp clockwise 180 degrees so that it is in locked position.Robotic Drive is now ready for guidewire and device loading (Figure 8-3).

Figure 8-3: Locking Track Clamp

Caution: System will not operate properly if Track Clamp is unlocked

Note: Bedside controls are disabled when Track Clamp is in locked position

9. Loading Guidewire into Single-use Cassette

1. When prompted by system, open cassette cover, Rotary Gate, and Linear Gate.

Figure 9-1: System prompt to prepare to load guidewire

2. DefinitionsThe following abbreviations are used in this manual:CTO chronic total occlusion PCI percutaneous coronary intervention

3. Manual PreparationsOperator must manually perform the following:• Initial canulation of guide catheter into coronary ostium• Loading or exchanging of guide catheters, guidewires, balloons, and stent systems• Contrast injections• C-arm movements• Balloon inflations• Medication administrationNote: The CorPath GRX system requires a minimum of 12.4 cm 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 3-1).

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.

Fig 3-1: Minimum Exposed Guide Catheter length needed to load into Cassette

4. 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.

5. Preparing Proximal End of Guide Catheter

It is recommended that the Drive Gear be connected to Y-Connector and guide catheter before engaging guide catheter in the coronary ostium

Fig 5-1: Drive Gear and Y-connector junction

1. Remove Drive Gear from its package according to aseptic technique.2. Connect Drive Gear to Y-Connector. (See Figure 5-1).3. Connect Drive Gear to guide catheter. (See Figure 5-2). Use care to attach Drive Gear

firmly.

Fig 5-2: Drive Gear and Guide Catheter Connector

Note: Check Luer connections for leaks and tighten as necessary to avoid loss of pressure during procedure.Guide catheter is now ready to be manually engaged in coronary ostium according to standard PCI practice.

6. Attaching Single-Use Cassette

1. Remove Single-use Cassette from sterile package according to aseptic technique.2. Attach Single-use Cassette to 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 6-1).

Figure 6-1: Attaching Cassette to Robotic Drive

3. Press down on Track Clamp to connect it into Track Clamp Holder. The Track Clamp Lever should be in the “unlocked” position. (See Figure 6-2).

4. The CorPath GRX system will recognize the Single-use Cassette attachment and will prompt user to continue.

5. Unclip the Guide Catheter Track from the front of the cassette so that the track can straighten [Figure 6-3, Arrow #1].

6. Open the Rotary Drive Cover, remove Orange Key [Figure 6-3, Arrow #2].

Figure 6-2: Track clamp connected to Robotic Driver with lever unlocked

Figure 6-3: Unclip Track and Remove Orange Key

7. Align Rotary Drive with Linear Drive [Figure 6-3, Arrow #3], and close cover [Arrow #4].

Note : System will not operate with 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 6. 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.

Fig 6-4: Tilt Robotic Drive Counterclockwise 30 degrees

7. Positioning Extended Reach Arm for Case

1. Press Arm Unlock Button on Robotic Drive Handle to unlock Extended Reach Arm. While pressing unlock button, position Robotic Drive to align it with axis of introducer sheath and guide catheter. Cassette should be positioned so that Y-Connector reaches Y-Connector Holder comfortably, without the guide catheter being tugged, or hanging with excess slack. (See Figure 7-1).

Figure 7-1: 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 7-2).

Caution: Ensure 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 track and guide catheter are positioned to align with the sheath to minimize the bending of the guide

Figure 7-2: Rail Clamp Release Lever Figure 7-3: Robotic Drive, Fine-tune Controls

Caution: Tugging on guide catheter during system set-up can result in unintended motion at distal end of guide catheter. Exercise caution and maintain guide catheter position 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 to adjust the location of Robotic Drive before loading guide catheter onto cassette. (See Figure 7-3). 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 guide catheter and devices are NOT loaded onto the cassette when using the fine-tune controls.

8. Loading Guide Catheter

1. Open lid on Y-Connector Holder.

Fig 8-1: Loading Y-Connector

2. Position Drive Gear in Y-Connector Holder [Figure 8-1, Label #1]. Hold Drive Gear in place while rotating Y-Connector as needed to position the Y-Connector as shown. Ensure Y-Connector is properly seated in Y-Connector Holder and that Y-Connector Holder lid can close fully.

3. Position guide catheter so that it is inside slot at distal end of the cassette as shown in Figure 8-1 [Arrow #2].

4. Close lid of Y-Connector Holder.5. Gently pull Guide Catheter Track out from cassette, so that it completely

encapsulates guide catheter. The guide catheter must completely sit within the middle of the sheath retainer to aid in encapsulation.

6. Hold onto the introducer sheath to ensure guide catheter and sheath do not move. 7. While aligning the gap in the sheath retainer to the sheath port, attach track to

introducer sheath by capturing the sheath port in the sheath retainer. Use left hand with force to rotate the white proximal end of the sheath retainer towards user as shown in Figure 8-2 to ensure support track is secure.

8. Use joysticks and/or Touchscreen controls to navigate guidewire to target location.

11. Exchanging a Wire or Balloon/Stent Catheter1. Press “Load/Exchange Devices” on Bedside Touchscreen2. When prompted by system, open cassette cover, Rotary Gate and Linear Gate. Caution: Guidewire is no longer fixed by system. Ensure that guidewire position is maintained by manually holding wire, or by anchoring it in Wire Holder during loading of balloon/stent catheter. Take care not to kink the wire when inserting it in the Wire Holder.

3. Lift guidewire and balloon/stent catheter 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 technique, remove balloon/stent catheter from guidewire.6. Load new balloon/stent catheter onto guidewire until catheter is advanced into

Y-Connector past its coaxial portion and to first marker. (See Figure 11-1).

Figure 11-1: Loading Balloon/Stent Catheter

7. Gently remove guidewire from Wire Holder and tilt the Y-Connector downward until it clicks in place. Fit guidewire into guidewire track and balloon/stent catheter into device track.

Figure 11-2: Placing Balloon/Stent Catheter in Single-Use Cassette

8. Close cassette cover and gates9. Touch “Enable All” icon on Control Console to activate joysticks and Touchscreen.

150 - 04992 Rev A