Omega Critical Care Ltd.

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FAQ



Q. Who are Omega Critical Care?
A. Omega Critical Care (OCC) Ltd. was founded in Scotland in August 2003. Omega Critical Care is a Scottish development company that intends to market medical devices related to the monitoring of key haemodynamic parameters in the critically ill patient within the hospital environment. During 2003, OCC purchased the IP rights, trademarks, inventory of monitors and manufacturing assets to the truCCOMS Monitoring System.

Q. How has the truCCOMS^� product been changed?
A. The physical appearance of the system has not changed, however in response to user feedback and a review of the product when bought by OCC it has been enhanced by: � Minimising the amount of vinyl adhesive at both ends of Heat Transfer Device in order to improve rate of heat transfer. Excessive adhesive was applied to earlier catheters when the product was marketed before. This reduced the efficiency of the heat transfer causing inability to reach higher CO because of less thermal gradient present at higher flows. � Calibration of catheters at 2� ^C rather than 2.5� ^C � Changes have been made to make navigation around the system smoother and to enhance user satisfaction with the product. � A �Zoom� feature has been added to allow better recognition of small changes in Cardiac Output. � Users can now download the history file and import into the truCCOMS^TM macro for automatic calculation of linear regression and Bland Altman plots. � If users switch to history mode, monitoring of CO continues uninterrupted. � Users will now have one TD probe supplied with monitor, which can be used for conventional thermodilution measurements if desired.

Q. Does the Heat Transfer Device heat the patient's blood?
A. No - With truCCOMS the heat transfer rate is less than 1 watt. Since 1 watt is equal to a 0.24 cal/sec, the heat generated is insignificant and is easily dissipated in the lungs without any resultant changes in blood temperature.

Q. Why is there a 2�C difference?
A. 2� C was found to generate an adequate, safe temperature gradient for heat transfer.

Q. How can I check the accuracy of truCCOMS against standard bolus thermodilution methods?
A. The true gold standard for doing this is to take the measurements in-vitro. truCCOMS offers you the benefit of having both continuous and intermittent cardiac output measuring so should you wish you can periodically check the continuous readings by switching to standard TD mode, and perform thermodilution measurement using bolus injection of saline. Data can be downloaded in excel format and regression and Bland Altman analysis performed.

Q. Can your monitor link to my main monitoring system?
A. No - At present, truCCOMS is a stand alone monitor but we believe that in the future it will be integrated with other patient monitoring systems.

Q. Does truCCOMS have to be managed by medical staff?
A. No - Because the display is updated every 1 second the readings can be recorded during the regular observations taken by the nursing staff allowing early warnings or indications of deterioration to be viewed immediately and preventative action taken. The continuous nature of the monitoring also means that the medical staff do not have to be present frequently to take TD measurements.

Q. How long can the truCATH catheter be left in the patient?
A. truCATH should be left indwelling only as long as required by the patient's condition. The incidence of complications increases significantly with indwelling periods longer than 72 hours. The duration of catheterisation should not exceed 72 hours. For full details please refer to truCATH Directions for Use and your own Hospital Standards and Guidelines for guidance on individual policies.

Q. Can truCCOMS be used in patients who are undergoing Intra-Aortic Balloon Counterpulsation (IABP)
A. Yes.

Q. We monitor Sv0₂ and your device doesn't have that facility?
Sv0₂ is dependant on serveral variables: � Changes in haemoglobin - if the patient is anaemic this may affect the readings. � Arterial saturation � Tissue oxygen requirements can result in changes in the mixed venous saturation. � Cardiac Ouptut If any of these measurements are compromised or fall outside the normal range, the Sv02 reading may well be inacurate. As such, it is not a very specific indicator of a patients condition because all of the above are ultimately affected by the heart and its ability to pump out blood. If the heart cannot pump effectively, the Sv02 reading will be inacurate. Thus the best way to measure CO is via truCCOMS directly at source. Proponents of continuous Sv02 monitoring, state that Sv02 is a reflection of cardiac output and suggest that measurements of Sv02can be substituted for measurements of cardiac output. Meausrements obtained intermittently, such as cardiac output, may not indicate changes in a patient's condition; therefore, therapeutic interventions may be delayed.

Q. Any contraindications when using truCCOMS?
A. There are no absolute contra-indications to the use of flow-directed pulmonary artery catheters. However patients with either recurrent sepsis or hyper-coagulopathy in which the catheter could serve as a focal point for septic or bland thrombus formation shoud not be considered candidates for a balloon flotation catheter. Also, the truCATH is contraindicated in patients with a known sensitivity to latex or heparin. Please refer to the truCATH Directions for Use for full and complete instructions. In addition, diathermy can sometimes interfere with the continuous functioning of the truCCOMS system. Please refer to the Operator Manual for further details.

Q. Who is the best person to talk to about Omega Critical Care?
A. The best people to answer your questions would be: Lucio Jannetta, Finance Director Office: +44(0)1355 265733 email: lucio@omegacriticalcare.com Susan Clarke, Marketing Services Manager Mobile: +44(0)7941 934460 Office: +44(0)1355 265733 email: susan@omegacriticalcare.com Lauren Newland-Nell, UK Sales Specialist Mobile: 07908 530721 email: lauren@omegacriticalcare.com Lindsay MacCallum, Clinical Product Specialsit Mobile: +44 (0)7917 770863 Office: +44 (0)1355 265733 email: lindsay@omegacriticalcare.com

Q. How do I become a distributor?
A. Complete our on line form or contact our Marketing Services Manager, Susan Clarke at susan@omegacriticalcare.com


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Principle

Using an innovative application of the Mass-Heat Transfer principle, the Omega truCCOMS� is fundamentally different from all other CO measurement technologies.

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