Edwards Lifesciences
Vigilance Monitor CCO and SvO2 Abbreviated Instructions for Use
Abbreviated Instructions for Use
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Edwards Vigilance Monitor Continuous Cardiac Output (CCO) and Mixed Venous Oxygen Saturation (SvO2) Abbreviated Instructions for Use CCOmbo Catheter Length: 110 cm Size: 7.5 F Recommended Introducer Size: 8.5-9.0 F Shelf Life: 18 months
CCOmbo VIP Catheter Length: 110 cm Size: 8 F Recommended Introducer Size: 9.0 F
The Swan-Ganz CCOmbo and CCOmbo VIP Catheters and Vigilance Monitor provide the traditional parameters of the Swan-Ganz catheter with the addition of continuous cardiac output and mixed venous oxygen saturation monitoring.
PA Distal Port Balloon Inflation Volume • Appropriate inflation volume is 1.25 – 1.5 cc
VIP Port 777F8, 777HF8 • 30 cm from tip
•Transduce distal lumen – proper waveform is PA
Thermistor •4 cm from tip •In main body of PA
Proximal Injectate Port • 26 cm from tip • Located in RA or SVC • If incorrectly positioned in introducer sheath, Bolus CO measurement will be erroneously high due to reflux of injectate within introducer • Transduce Proximal Injectate Lumen – proper waveform is RA or SVC
Thermal Filament • 14 – 25 cm from tip • Rests between RA and RV • Should be free floating and avoid endocardial surface • Erroneous CCO measurements may result if beyond pulmonic valve Note: Assess patient physiology. Atypical physiology and heart size may require special handling.
The Swan-Ganz CCOmbo and CCOmbo VIP Thermodilution Catheters Model 744HF75 and 746HF8
Troubleshooting the CCOmbo Catheter PROBLEM OR DISPLAYED MESSAGE
POSSIBLE CAUSE
SUGGESTED ACTION
CCO measurements do not agree with Bolus CO measurements
• Catheter Position
• Verify proper catheter position: - Balloon inflation 1.25-1.5cc. - Check for PAWP tracing. - Transduce Injectate (RA/Blue) Lumen.
• Instrument Configuration
• Verify that injectate volume and catheter size OR computation constant have been correctly selected.
• Faulty thermistor or injectate probe connection
• Check injectate probe and catheter connection.
• Unstable baseline temperature affecting bolus CO measurements
• Assess factors affecting PA temperature stability: - Rapid bolus infusions. - Shivering. - Patient movement. - Fighting ventilator. - Wait 60 seconds between injections.
“Check Thermal Filament Position”
• Flow around thermal filament may be reduced
• Verify proper catheter position. • Verify free floating state of catheter.
“Warm Injectate” or “Injectate too Warm. Check Probe”
• Injectate temperature within 8°C of blood temperature • Injectate temperature >30°C
• Use cooler injectate fluid: - Maintain ice slush solution. - If prefilled syringes, remove from cold source and use within 15 seconds. • Check injectate probe connection. • Replace injectate temperature probe.
“SQI = 4”
• Catheter too distal • Low blood flow at catheter tip or catheter tip against vessel wall • Change in Hgb/Hct values
• Verify proper catheter position. • Verify patency of catheter.
• Catheter kinked or damaged
• Update Hgb/Hct values using UPDATE function. • Check catheter for kinking and recalibrate. • Replace catheter if required and recalibrate. • After all above troubleshooting measures are utilized, press OPTICAL RESET.
“Red/IR Transmit”
• Optical Module contamination/ Optical Module damage
If problem persists, call Edwards Technical Support at 1.800.822.9837 (US and Canada) or 949.250.2222.
• Disconnect catheter from OM. • Clean Optical connector on catheter andOM. • Reconnect. If Error message disappears, do INVIVO calibration. • If Error message remains, try different Optical Module. • If Error message remains, change catheter. Edwards Lifesciences, Edwards, the stylized E logo and VIP are trademarks of Edwards Lifesciences Corporation. CCOmbo, Swan-Ganz and Vigilance are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. © Copyright 2002 Edwards Lifesciences LLC. All rights reserved. 1130A-6/00-CC
Edwards Lifesciences LLC · One Edwards Way · Irvine, CA 92614 USA · 949.250.2500 · Fax: 949.250.2275 · www.edwards.com Edwards Lifesciences (Canada) Inc. · 1290 Central Pkwy West, Suite 300 · Mississauga, Ontario · Canada L5C 4R3 · 905.566.4220 Edwards Lifesciences S.A. · Ch. du Glapin 6 · 1162 Saint-Prex · Switzerland · 41.21.823.4300 Edwards Lifesciences Japan · 2-8 Rokubancho · Chiyoda-ku, Tokyo 102-0085 · Japan · 81.3.5213.5700