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When in position, exert additional forward force in line with the shaft prior to and during needle

deployment. Slowly deploy the needle by simultaneously squeezing Levers A and B (see Figure 1

above) until Lever B is fully advanced. Forward pressure on the device prior to and during

deployment will prevent the tissue from migrating distally. Distal tissue migration during

deployment may lead to suture misfire.

During deployment, the suture outside of the access port should be observed advancing in tandem

with the needle-trigger advancement. If the suture does not advance, or if the suture breaks, the

suture may be pinched between the device and cannula seal. If this occurs, after reloading the device

with suture consider advancing the device beyond the tear in order to introduce slack in the suture

prior to positioning within the tear.

Release both Levers A and B and then retract the lower jaw by pushing down Lever C. Engage Lever

A and remove the device. Keep Lever A engaged when withdrawing the device from the joint in

order to keep the upper jaw parallel with the shaft. Remove the suture end from the upper jaw by

pulling in the proximal direction, parallel to the upper jaw.

If the 2-0 or 0 suture is being passed to subsequently shuttle #2 suture, create a loop in the suture

limb that exits on the glenoid side of the labral tissue and use that loop to shuttle the desired suture

through the labral tissue. If a loop is created prior to loading the suture, the free (non-looped) end

should be loaded into the device. This will ensure that the loop is positioned on the glenoid side of

the tear.

Complete the procedure as usual.

GENERAL USE

Bench deployment testing has demonstrated that the device can be reloaded with suture and fully

actuated 14 times. Cycling the device in excess of 14 deployments may impact needle integrity and

compromise performance.

Immediately discard the Ceterix NovoStitch Disposable Suture Passer after completion of the surgery.

The device is

SINGLE USE ONLY

STORAGE

Store in a cool, dry area.

P/N: LBL-0012 Rev: E

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Содержание NovoStitch

Страница 1: ...e order of a physician DESCRIPTION The Ceterix NovoStitch Disposable Suture Passer device is an arthroscopic suture passer designed to pass USP size 2 0 or 0 braided surgical suture through soft tissu...

Страница 2: ...y lead to changes in material characteristics such as corrosion and dulled edges which may impact the strength of the device and compromise performance Reprocessing of single use devices can also caus...

Страница 3: ...rect suture loading a Advance the lower jaw by holding the pistol grip without Lever A and squeezing Lever B until the lower jaw is fully advanced see Figure 2 Figure 2 Fully advanced lower jaw b Load...

Страница 4: ...IRECTIONS FOR USE PASSING SUTURE THROUGH MENISCAL TISSUE 1 Ensure portal placement and preparation is appropriate to access the region of the meniscus to be sutured 2 Advance the upper jaw along the s...

Страница 5: ...rder to keep the upper jaw parallel with the shaft Remove the suture end from the upper jaw by pulling in the proximal direction parallel to the upper jaw 8 If needed repeat steps 2 through 8 using th...

Страница 6: ...gage Lever A and remove the device Keep Lever A engaged when withdrawing the device from the joint in order to keep the upper jaw parallel with the shaft Remove the suture end from the upper jaw by pu...