Swan-Ganz Pacing TD CatheterD200F7, D200HF7, D205HF7

Swan-Ganz Pacing TD CatheterD200F7, D200HF7, D205HF7

THe PaCinG-TD CaTHeTer Can PerForm:• RAP, PAP, and PAOP pressure measurements

• Cardiac output measurements by thermodilution

• Pacing atrial and ventricular pacing and atrioventricular (A-V) sequential pacing

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Proximal Injection Lumen Hub

Gate Valve

Distal Lumen HubThermistor Connector

Proximal Atrial

CentralAtrial

DistalAtrial

ProximalVentricular

DistalVentricular

Balloon

Thermistor(back side)

1Ventricular Electrode

2

5 4 3 Stylet Anchor Brushing

Atrial Electrodes

Proximal InjectionPort

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aTrial PaCinG a-V SequenTial PaCinG

1. Connect the “distal atrial” electrode 3 to the negative pacemaker terminal. Connect the “central atrial” electrode 4 to the positive terminal.

notice: To facilitate a connection between the catheter and pacemaker, a cable adapter may be required.

2. Adjust the pacemaker output to 0.1 milliamps and the rate to 15% above the patient’s heart rate, or to a physiological rate. With the pacemaker turned on, slowly increase the output until atrial pacing occurs (see Figure 5). A typical atrial pacing current threshold is 5 milliamps. If atrial pacing does not occur, slowly advance or withdraw the catheter 0.5 cm at a time with the pacemaker operating at 5 milliamps and the balloon deflated.

3. Check the catheter position once again to make sure it has not been advanced to a permanent wedge position.

1. After achieving atrial and ventricular pacing, connect the two ventricular electrodes to the A-V sequential pacemaker; attempt pacing. Successful A-V sequential pacing is shown in above image.

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EquipmEnt1. Swan-Ganz Pacing-TD catheter2. Percutaneous sheath introducer and contamination shield3. Compatible cardiac output computer, CO-Set injectate probe4. External pacemaker (ventricular demand or A-V sequential)5. External pacemaker cable adapters6. Sterile flush system and pressure transducers7. Bedside pressure monitor system

PlaCemenT

Standard pressure waveform showing RA-RV-PA-PAWP-progression

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PAWP

PARV

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Surface ECG showing atrial pacing

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VenTriCular PaCinG

1. Connect the “distal ventricular” electrode 1 to the negative pacemaker terminal. Connect the “proximal ventricular” electrode 2 to the positive terminal.

2. Adjust the external generator R-wave sensitivity to approximately 3 millivolts to avoid competition between the pacemaker’s rate and the patient’s rate.

3. Repeat steps 1 and 2 to achieve ventricular pacing. Ventricular stimulation at 3 milliamps or less is generally obtainable. Check for adequate sensitivity once pacing is established. Successful ventricular capture is shown in above image.

Unused electrode connectors must be capped to prevent their contact with a faulty ground.

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Surface ECG showing ventricular pacing

Surface ECG showing A-V sequential pacing

Catheter position before and after pulling back from initial wedge position

Final Catheter Position

A. Before B. After

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note: The Atrial Proximal Lead (5th lead) is used at the clinicians discretion when unable to capture or obtain satisfactory thresholds in the atrium using lead 3 and 4.

note: Diaphragmatic pacing may occasionally occur; it can usually be alleviated by advancing the catheter 0.5 to 1 cm.

Precaution: If atrial and ventricular pacing occur only with the catheter in a permanent wedge position, withdraw the catheter to a pulmonary artery position. In this situation, pacing is sacrificed because of the likelihood of pulmonary infarction resulting from the catheter being permanently wedged.

For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, AMC THROMBOSHIELD, Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

© 2013 Edwards Lifesciences Corporation.All rights reserved. AR10036

Edwards Lifesciences | edwards.comOne Edwards Way | Irvine, California 92614 USASwitzerland | Japan | China | Brazil | Australia | India

PaCinG leaD-PaCemaker Cable ConneCTionimportant: Effective May 9, 2000, FDA regulation 21 CFR 898 requires changes affecting pacing catheters and probes. Your current external pacemaker cable may not be compatible with the modified catheter leads. Please follow these instructions to facilitate connection.

option 1: Use the universal adapters enclosed in this package with any external pulse generator cable equipped with a mechanism that mechanically secures the adapters in place.

option 2: Use cable models equipped with alligator clips option 3: Cables facilitating a direct connection between the catheter modified with shrouded pin connectors and external pulse generators may be available from other manufacturers.

Step 1. Insert and secure adapter to cable

Shrouded Pin Connector Universal AdapterPulseGeneratorCable

Step 2. Connect or disconnect shrouded pin connector and adapter

Shrouded Pin Connector Alligator Clip Connection

From Catheter

To PulseGeneratorCable

model number Computation Constants D200F7, D200HF7& D205HF7

Temp (°C) Volume (ml) Computation Constants (cc)*

0-5 10 0.542 5 0.247 3 0.132 19-22 10 0.578 5 0.274 3 0.154

Computation Constants for Co-Set+

Cold Injectate 10 0.561 10 ml: 6-12°C 5 0.2595 ml: 8-16°C 3 -

Room Temperature 10 0.608Injectate 5 0.3015 or 10 ml: 18-25°C 3 -

*CC = (1.08)CT(60)Vi

Function atrio-Ventricular Pacing and Thermodilution model number D200F7, D200HF7 D205HF7CoC Compatibility edwards edwards

Usable Length (cm) 110 110

Catheter Body French Size 7F 7F

Required Introducer Size 8F 8F

Body Color Yellow Yellow

Diameter of Deflated Balloon 8F 8F

Diameter of Inflated Balloon (mm) 13 13

Balloon Inflation Capacity (ml) 1.5 1.5

Injectate Port (cm from tip) 30 29.5

Injectate Lumen Volume (ml) 0.93 0.93

Electrode Material Elgiloy, 2 mm long Elgiloy, 2 mm long

Electrode Connector 0.40” x 0.080” dia pin plugs 0.40” x 0.080” dia pin plugs

Atrial Electrodes (cm from tip) 28.5, 31.0, 33.5 25.5, 28.0, 30.5

Ventricular Electrodes (cm from tip) 18.5, 19.5 15.5, 17.5

Permanent Stabilizing Stylet* Yes Yes

Compatible Guidewire Diameter (in) 0.020 0.020

Distal Lumen Natural Frequency/

Amplitude Radio 16 Hz 1.6:1

16 Hz 1.6:1

Thermistor Location (cm from tip) 4 4

Catheters are constructed from quadruple-lumen, polyvinylchloride, radiopaque extrusions; catheters with the AMC THROMBOSHIELD coating are denoted by an “H” in the model number.

* Catheters with permanent stabilizing stylets are not suitable for placement through the inferior vena cava. All specifications given are nominal values.

TD ComPuTaTion ConSTanTS CaTHeTer SPeCiFiCaTionS