Updated January 2006

1. Updated January 2006 1

2. Updated January 2006 2 Crit-Line III TQA Monitor

3. Updated January 2006 3 Back Panel

4. Updated January 2006 4 Monitor 5lbs HCT range: 5-60 (+/- 1 Standard Deviation) O2 saturation range: 10-100% (+/- 2 Standard Deviation with sats between 55-100%) Blood Pump ( QB) 50- 1300ml/min

5. Updated January 2006 5

6. Updated January 2006 6 O2 Saturation Accuracy

7. Updated January 2006 7 Power Supply AC or Battery 10.3V (volts) needed to operate Battery takes 36 hours to fully charge Fully charged Battery lasts 2 hours Turn Screen off at night Always keep the monitor plugged in Quick release power supply cord disconnects easily

8. Updated January 2006 8 Power Supply Green charging indicator light is on if plugged in Machine is charging even if it is on during a patient run-as long as the green light is on There is a 2-minute “Low voltage” warning message before the screen goes blank *If battery dies: Turn the machine off, plug it in, and wait 20 seconds before turning it back on Keep the power supply unit off the floor, out of water

9. Updated January 2006 9 Memory The TQA Memory bank holds 26 hours of information “Memory Full” will appear if: -Any data is entered prior to shutting off the machine - Any data is entered prior to battery depletion -Less than 4 hours is left prior to starting a new patient run

10. Updated January 2006 10 Memory Only “Clear Memory” will clear the memory: - Losing power does Not clear the memory - Printing does NOT clear the memory Once memory is cleared, data can Not be retrieved Printing can be to a serial or parallel port printer Download data to Crit-line reporter software in PC Wireless options are available thru Aerocomm

11. Updated January 2006 11 Blood Chamber 36 per box Polycarbonate window / cuvette Off yellow in color Sterile 3 year shelf- life ( expiration on package and box ) Disposable( optical properties can change with reuse)

12. Updated January 2006 12 Blood Chamber Attach to arterial header Twist using wing located near the arterial connection, not the blood chamber Turn till threads are covered Ensure tight connection Do not use excessive force Can’t really see the wing in this picture- Show an actual example.Can’t really see the wing in this picture- Show an actual example.

13. Updated January 2006 13 Blood Chamber Holds 3 ml. of Saline Air bubbles / saline may cause underestimation of HCT Can Pre-prime / Post-prime Wait 3 minutes after initiating TX to ensure removal of prime before pressing “Start Run”

14. Updated January 2006 14 Sensor Clip Light emitting Diodes and Photodetectors Colored red to show sensor is on Isobestic wave lengths for finding HCT & O2 in whole blood

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18. Updated January 2006 18 Sensor Clip Placement Snap on perpendicular to blood chamber Ensure proper contact is maintained Do not pull on / tie knots in sensor cable Store in /on Docking station (verification filter) between use Each monitor has its own sensor clip and verification filter

19. Updated January 2006 19 “Monitor Specific” Verification Filter Low HCT / Oxygen control - HCT between 15-20 - O2 range around 70% Monitor defaults to a monthly verification Recommend every day of patient use 2 minute self test Maintain Verification log or print out graph Calibrate only if verification fails x2

20. Updated January 2006 20 KEYPAD Controls mode of operation: Menu: To enter main menu and optional menu screens Arrows: Move cursor up or down Enters Intervention arrows every 5 min Mutes alarm for 5 min Red light: Warning light for HCT Limit Select: To choose your selection

21. Updated January 2006 21 Cleaning Damp cloth: Never Spray the monitor Use diluted bleach solution on contaminated areas Use plain water to remove bleach film Clean inside of sensor clip and the verification filter, if verification fails Use a Q-tip with water or diluted bleach for the inside of sensor clip and verification filter Clean inside of sensor clip / verification filter with Windex once a month

22. Updated January 2006 22 Display Screens Primary Screens: Main Menu (choose operating mode) Startup ( Initializing screen) Profile Screen (plotted graph of either HCT, O2, or BV change over TX time) Monitor will default to the BV screen To change the default screen, press Menu twice, move cursor to desired screen, and Select it

23. Updated January 2006 23 Profile Display Screens Second to second updates in the numeric values of HCT, O2, and BV changes on bottom of screen Absolute / immediate / real time values Graph updates every 60 seconds HGB calculated from the measured HCT Displays dotted alarm line at selected HCT Limit HCG = (.3112 x HCT) + .71HCG = (.3112 x HCT) + .71

24. Updated January 2006 24 HCT Threshold Critical Blood Volume level identified by the HCT at which the patient experiences morbid symptoms Specific for each patient The “Crash Crit”

25. Updated January 2006 25 HCT Threshold Definition: the HCT at which the patient experiences symptoms of morbidity (The Crash Crit). Rule of thumb…. Until you establish a HCT Threshold, set the HCT Limit at 15% of the starting HCT. EXAMPLE : Starting HCT 30% Set limit at 34% Review it every 3 weeks: it can change as the RBC mass changes with EPO titration/ Blood loss or gain.

26. Updated January 2006 26 Hematocrit Limit HCT Limit can only be set higher than the current HCT displayed Once the HCT Threshold is known, set the HCT Limit 1-2 HCT units below the HCT Threshold If the HCT Threshold is unknown, set the HCT Limit approx 15% above the starting HCT (approximately 3-5 HCT points) There is an audible and visual alarm when the HCT Limit is reached The HCT Limit is displayed as a dotted alarm line The dotted alarm line is called the “crit-line”

27. Updated January 2006 27 Oxygen saturation: The percent to which the hemoglobin (HGB) is filled with oxygen. 97% means that 97% of the total amount of HGB is filled with oxygen molecules 90 to 100% is considered normal for arterial sats; > 60% for mixed venous sats Oxygen Saturation 1.Below 90% could lead to life threatening complications for arterial sats; COPD may range in high 70s, mid 80’s) 2. For Venous sats: Below 60% denoted cardiac dysfunction; below 30% is Severe cardiac dysfunction1.Below 90% could lead to life threatening complications for arterial sats; COPD may range in high 70s, mid 80’s) 2. For Venous sats: Below 60% denoted cardiac dysfunction; below 30% is Severe cardiac dysfunction

28. Updated January 2006 28 Relationship between HCT and O2 Saturation The more anemic the patient (the lower the HCT), the fewer total HGB molecules they have. This causes the total amount of oxygen available to the tissues to be low, even though the hemoglobin present is full of oxygen . This produces a normal, misleading O2 saturation The O2 sat must be interpreted in the context of the patient’s degree of anemia. False sense of Security unless the O2 sat is interpreted in the context of the patients total Hgb False sense of Security unless the O2 sat is interpreted in the context of the patients total Hgb

29. Updated January 2006 29 Troubleshooting: Prevention “Start Run” on Blood chamber versus Verification Filter Wait 3 minutes after initiating TX to “Start Run” Prime per procedure to remove all air Ensure Bld chamber and sensor clip are clean and dry Keep plugged in Protect from dropping Prevent saturation of machine/ power supply unit Press “Stop” before beginning rinse back

30. Updated January 2006 30 Troubleshooting: Warning Messages 1. Sensor Obstructed: - Foreign material - Clot ( HCT > 60): too much light wave absorption - QB stopped 2. No blood Detected - Air / Saline - Detached sensor clip 3. Low Voltage - Less than 10.3 V 4. Sensor Malfunction - Sensor or cable damage 6. Back Lit Values: temporarily lost lock onto HCT - Saline flush “Service recommended” is no longer in the new monitor versions. “Service recommended” is no longer in the new monitor versions.