Medtronic DLP 50010 Instrucciones De Uso página 6

Equipo de cateter de presion con introductor

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Directions for Use

Pressure Catheter Placement Set

Model

50010

(3 Fr.)

50011

(5 Fr.)

50013

(5 Fr.)

Description

The PCP set includes a flexible radiopaque plastic catheter (3 or 5 French), 24" (61.0 cm) long. A rigid plastic

female luer connector is permanently attached to the proximal end of the catheter. Depth markings on the tube

serve as insertion depth indicators. Code #50010 is supplied with two winged introducer needles:

17 ga x 2.6" (6.6 cm) breakaway type needles. Code #50011 is supplied with two winged introducer needles:

14 ga x 2.6" (6.6 cm) breakaway type needles. Code #50013 is supplied with a 14 ga slotted placement needle

and a 14 ga x 2.6" (6.6 cm) breakaway winged introducer needle.

Sterile, Non-pyrogenic, Disposable.

Indications

This PCP set is intended for use in perioperative monitoring of the left atrial pressure.

Contraindications

This device is not intended for use except as indicated above.

Warnings

Care should be taken not to damage the catheter during introduction through the needle. DO NOT DRAW

CATHETER BACK THROUGH NEEDLE.

Inadvertent introduction of air into the system is dangerous. Use only locking type luer fittings and insure that the

associated circuits will not allow air to enter the catheter.

Caution: Catheter may not be detectable by x-ray in some cases due to variances in anatomical densities and x-

ray techniques.

Caution: Do NOT allow luer hub to come in contact with alcohol-based solutions.

Precautions

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Note: Proper surgical procedures and techniques are necessarily the responsibility of the medical profession. The

described procedure is furnished for information purposes only. Each surgeon must, of course, evaluate the

appropriateness of the procedure based on their own medical training and experience, and the type of surgical

procedure.

When removing the catheter from the patient, withdraw it completely and check to see that all of the catheter has

been removed by referencing the 3 security dots at the end of the catheter.

This PCP set is designed and intended for single use only. DO NOT REUSE.

Adverse Effects

None known.

Directions for Use

Inspect the package and product for damage and expiration date. If undamaged and unexpired, open the

package and transfer the PCP set onto the sterile field utilizing an aseptic technique.

Remove the anchoring collar from the catheter.

The catheter has three sets of depth markings. If a shorter catheter is desired, cut the catheter immediately

below one of the sets of three circular dots.

Introduce the breakaway catheter introducer needle through the chest wall.

Pass the catheter through the needle and into the thoracic cavity.

Remove the breakaway catheter introducer needle. To remove from around the catheter, withdraw the

needle from the chest wall, pinch the wings on the needle together, then grasp each wing and pull to

separate.

Place a purse string suture in the right superior pulmonary vein. Introduce the remaining catheter introducer

needle (#50010 and #50011) or the slotted needle (#50013) through the purse string suture and into the

vein.

Introduce the catheter through the introducer needle using one of the following methods:

#50010 and #50011:

a. Advance the catheter approximately 2 cm into the left atrium depending on patient anatomy.

b. Remove the catheter introducer needle using the same technique as outlined in step 6.

#50013:

a. Place the end of the catheter into the wide portion of the slot. Feed the catheter forward by pushing the

catheter into the base of the slot at a 45 degree angle until the tip of the catheter is located about 2 mm

behind the point bevel (Figure 1).

b. With a 180 degree twisting motion, insert the needle and catheter into the right superior pulmonary vein

within the confines of the purse string suture.

c. Grasp the catheter immediately above the site where the catheter enters the slotted needle and withdraw

the needle (Figure 2).

After the needle has been removed and the catheter is properly positioned in the left atrium, secure the

purse string suture around the catheter.

10. Aspirate the catheter to remove any air bubbles. Attach a monitoring line having a locking male luer fitting

and remove all air from the catheter and monitoring line.

11. Remove the white polyethylene adhesive backing from the anchoring collar. Lay the catheter on the adhesive

pad.

12. Fold the adhesive pad and press both halves firmly together.

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