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Echelon CircularECHELON CIRCULAR Powered Stapler Optimized Device Performance Guide

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Page 1: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

Echelon Circular™

ECHELON CIRCULAR™

Powered StaplerOptimized Device Performance Guide

Page 2: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

Device overviewECHELON CIRCULAR™ Powered Stapler

Orange Band

Staple Housing

Device Trocar

Knife Outside Diameter

Tissue Compression Scale

Adjusting Knob

Battery Pack

Red Safety

Firing Trigger

Staple Retaining Cap

Finger Notch

Ancillary TrocarAnvil Shaft

Locking Spring

White Breakaway Washer

Anvil Cap

Suture Tying Area

Anvil Grasping

Area

Page 3: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

Device preparation

2. Opening and Staple Retaining Cap removal

Rotate Adjusting Knob counterclockwise until the Anvil Shaft is fully exposed and remove Staple Retaining Cap.

1. Install Battery Pack

The Battery Pack must be installed prior to use. Ensure the Battery Pack is fully inserted into the device. An audible click will be heard and the Tissue Compression Scale backlight will be illuminated when the Battery Pack is fully inserted.

3. Anvil removal

Pull Anvil to remove from Trocar.

4. Device Trocar retraction

Retract Device Trocar by rotating Adjusting Knob clockwise until a stop is reached.

Check Device Trocar

Verify it is fully retracted before proceeding.

Anvil and device placement

5. Anvil placement

Insert Anvil into Lumen.

6. Secure Anvil

Secure the purse string onto Anvil Shaft above Suture Tying Area.

7. Device placement

With Device Trocar retracted, insert Device up to closed Lumen.

8. Device Trocar penetration

Fully extend Device Trocar and pierce tissue by holding the device while gently rotating the Adjusting Knob counterclockwise.

9. Tissue adjustment

Once penetrated, fully extend Device Trocar and push tissue down until Orange Band is visible.

10. Attaching Anvil

Using an Anvil Grasper or similar instrument, grip Anvil Grasping Area, being careful not to grasp locking springs. Slide Anvil Shaft over Device Trocar until Anvil snaps into fully seated position. The Orange Band on the Device Trocar will be covered when the Anvil is fully attached.

If necessary, hold the adjusting knob to prevent the Device Trocar from retracting during laparoscopic anvil attachment.

NOTE: Anvil Grasper can be used to prevent tissue tenting during Device Trocar penetration.

For complete product details, refer to the relevant package inserts, with particular attention paid to the indications, contraindications, warnings and precautions, and steps for use of the device.

Page 4: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

Tissue compression

12. Tissue compression selection

Continue closing device until tissue is adequately compressed for proper anastomosis. Wait 15 seconds to allow for adequate tissue compression and adjust if needed to maintain appropriate tissue resistance.

Device firing

13. Red Safety disengagement

Confirm Orange Indicator is fully within green range. Draw Red Safety back toward the handle. The device will not fire if the anvil is not properly attached or if the Orange Indicator is not fully within the range of the Green Tissue Compression Scale.

14. Firing

Activate the firing sequence by completely depressing the Firing Trigger. Keep device still and do not attempt to manipulate the Adjusting Knob until the firing sequence is completed, which will be indicated by an illuminated green check mark on the indicator window.

It is not necessary to hold the trigger once the firing sequence has initiated. The user may notice audible feedback during the firing sequence when cutting through the Breakaway Washer. Once fired, the device cannot be fired again.

For complete product details, refer to the relevant package inserts, with particular attention paid to the indications, contraindications, warnings and precautions, and steps for use of the device.

Before firing After firing

11. Closing device

Close by turning Adjusting Knob clockwise until Orange Indicator enters the green range on the Tissue Compression Scale, keeping anastomotic segments in proper orientation to prevent twisting of tissue.

Page 5: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

Device opening and removal

15. Open Device

Open device by turning Adjusting Knob counterclockwise for 2 complete 360° revolutions (2 X 360°) or 4 half turns (4 x 180°)

16. Remove Device

Rotate the device 90° in both directions taking care to minimize movement of the distal tip. This ensures the tissue is released. Gently pull out the device while simultaneously rotating device back 90°.

Repeat as required until device slides out.

CAUTION: If the device does not freely release from the anastomosis or withdraw easily after rotation, turn the adjusting knob counterclockwise one additional complete revolution (360°) and attempt removal again by rotating the device 90° in both directions, taking care to minimize movement of the distal tip. Gently pull out the device while simultaneously rotating.

Anastomosis check

17. Breakaway Washer and Donuts check

Fully open device and extract Breakaway Washer and Tissue Donuts.

18. Examine Donut and anastomosis integrity

Examine the integrity of the Tissue Donuts and White Breakaway Washer. Donuts should be intact and include all tissue layers. Ensure that Donuts are complete, and the White Breakaway Washer is completely transected into inner and outer concentric rings. If Donuts or Breakaway Washer are not complete, the anastomosis should be carefully checked for leakage and appropriate repairs made.

For complete product details, refer to the relevant package inserts, with particular attention paid to the indications, contraindications, warnings and precautions, and steps for use of the device.

2

Device opening and removal

1. Open DeviceOpen device by turning Adjusting Knobcounterclockwise for 2 complete 360° revolutions(2 X 360°) or 4 half turns (4 x 180°)

2. Remove Device Rotate the device 90° in both directionstaking care to minimize movement ofthe distal tip. This ensures the tissue isreleased. Gently pull out the devicewhile simultaneously rotating deviceback 90°.

Repeat as required until device slides out.

CAUTION: If you rotate the device and it does not freely release from the anastomosis or if the device does not withdraw easily, turn the Adjusting Knob counter-clockwise one additional complete revolution (360º), then attempt removal again by rotating the device 90° in both directions taking care to minimize movement of the distal tip.

1

2

2ND 360° Revolution(2 Half Turns)

½1½

1

½

1ST 360° Revolution(2 Half Turns)

Device opening and removal

1. Open DeviceOpen device by turning Adjusting Knob counterclockwise for 2 complete 360° revolutions(2 X 360°) or 4 half turns (4 x 180°)

2. Remove Device Rotate the device 90° in both directions taking care to minimize movement of the distal tip. This ensures the tissue is released. Gently pull out the device while simultaneously rotating device back 90°.

Repeat as required until device slides out.

CAUTION: If you rotate the device and it does not freely release from the anastomosis or if the device does not withdraw easily, turn the Adjusting Knob counter-clockwise one additional complete revolution (360º), then attempt removal again by rotating the device 90° in both directions taking care to minimize movement of the distal tip.

1

2

½1½

2

2ND 360° Revolution(2 Half Turns)

1

½½

1ST 360° Revolution(2 Half Turns)

Page 6: ECHELON CIRCULAR Powered Stapler - J&J Medical Devices · 2020. 8. 13. · Powered Stapler Optimized Device Performance Guide. Device overview ECHELON CIRCULAR™ Powered Stapler

For complete product details, refer to the relevant package inserts, with particular attention paid to the indications, contraindications, warnings and precautions, and steps for use of the device.

©2020 Ethicon, Inc. All rights reserved. 059221-200309

Ancillary Trocar use

1. Removing Ancillary Trocar

To remove the Ancillary Trocar from the Staple Retaining Cap, grasp the Finger Notches and pull straight out, parallel to the retainer body.

2. Attaching Ancillary Trocar

Grasp the Finger Notches of the Ancillary Trocar and place the blunt end into the Anvil Shaft.

3. Detaching Ancillary Trocar

Grasp the Anvil Grasping Area and grasp Finger Notches of the Ancillary Trocar. Rotate the Ancillary Trocar approximately 45° while pulling outward from Anvil Shaft.

Rotate the Ancillary Trocar with respect to the Anvil Shaft approximately 45° to ensure secure attachment.