ShockWatch Blood Temp

1. ShockWatch Blood Temp Minimizing loss & mitigating risk with ShockWatchBlood Temp

2. ShockWatch Solutions Increasing Value to Customer TrekView Intelligent Monitoring System ColdMark2 WarmMark2 Real-time Monitoring Performance Multi-use recorder Single use Low cost Go – No/Go Data Recorders ColdMark WarmMark Chemical Indicators Price

3. Red Blood Cell Regulatory Requirements • Blood must be stored between 1°C to 6°C • Blood cannot exceed 10°C when transported • Generally accepted 30-minute rule • Blood components may be held at ambient temperature for no longer than 30 minutes

4. Blood Life Cycle After donation, blood is stored in a refrigerator Unused blood is discarded if it cannot be determined that the cold chain was maintained properly. Blood is moved from a refrigerator to the operating room or emergency room

5. Blood Bag Temperatures As a filled blood bag is warmed from refrigerated temperature to room temperature, the temperature inside the bag will vary by location Temperature recordings by a thermographic camera of a blood bag removed from refrigerated storage (2°C-6°C) and placed at room temperature (25°C) for 33 minutes (Courtesy of JakobWoisetschläger, PhD, Graz University of Technology, Graz, Austria). Johnson, Langeberg, Makuria and Sandler 2006

6. Blood Bag Temperature Study Details • Digital thermometer temperature measurements were made of the contents of 5 units of red blood cells. • Temperatures were measured during refrigerated storage (1°C-6°C) at 5 locations inside the blood bags: a top corner, core/center surface, bottom midline, and a bottom corner. • Temperature measurements were repeated at the same locations after the bags had been removed from refrigerated storage and maintained at ambient room temperature (23.2°C-23.5°C) for 15 and 30 minutes. • After 15 min at room temp, differences could be detected in peripheral locations compared with core locations • After 30 min at room temperature none of the temperatures in the peripheral locations were consistent with the core temp • The center of the bag cools slower than the peripherals Johnson, Langeberg, Makuria and Sandler 2006

7. Design Considerations • Temperature indicator must: • Be easy to arm • Be easy to interpret (regardless of language) • Be easy to apply / handle • Suitable for mounting directly onto a blood bag • Monitor core blood temp (not air temp) • Display breach when blood core temp rises above 10°C • Be small and discreet • Solution – ShockWatch Blood Temp

8. ShockWatch Blood Temp • Application specific member of the WarmMark2 product family • Single-use temperature indicator • Field-armable • Easy to read with a definitive color change when armed and activated • Accurate • Identifies when blood bag core temperature reaches 10°C

9. Layout of Blood Temp Activation Blister Product is inert prior to activation Indication of Arming Turns green when product is active Breach Window Turns blue after temperature breach Unique Serial Number On every product

10. Blood Temp Construction Mask / Design Determines breach window layout Blister Housing Dye Solution Blister awaiting activation Membrane Dye travels through micro pores Aluminum Backing Derives greater core blood temp accuracy

11. How Blood Temp Works Inert: liquid in blister before arming Activated: blister squeezed, yellow to green color change in the arming window confirms product is armed. Breach: liquid moves into the breach window (blue color appears) when blood bag core temperature reaches 10°C

12. Applying Blood Temp to the bag • Blood bag must be pre-chilled to refrigeration temperature (2°C/36°F – 6°C/43°F) before applying the Blood Temp indicator • Ensure that the blood bag is clean, oil free and moisture free before applying • Blood Temp should be applied on the lower 1/3 of the blood bag since this is where the greatest volume of blood is held

13. Using the Blood Temp • Indicators must in an environment above 10°C/50°F • Firmly squeeze the blister located on the top of the indicator • Confirm that the Blood Temp has been activated appropriately by verifying that the arming window has changed from yellow to green • Re-squeeze the blister firmly if immediate color change does not occur • Immediately remove the adhesive liner and adhere the indicator to the prepared location on the blood bag • Apply constant pressure for 3-5 seconds to maximize adhesion quality • Blood bag is now ready for use!

14. Easy to Interpret Yellow window indicates product has not been armed. Green window indicates the device has been armed. Blue window indicates the blood bag core temperature has reached or exceeded 10°C White window indicates temperature control has been maintained.

15. Estimated Return on Investment • Reducing your loss rate by 8% pays for total investment. • A conservative 25% reduction more than triples your return. • Not captured in current costs (that may be reduced with monitoring program): • Administration fees • Biohazard waste disposal fees • Audits / Regulatory Fines • Potential Litigation

16. Benefits Reduce blood waste Increase patient safety Ensure regulatory compliance

17. Reduce Blood Waste Blood Temp allows you to determine if it is safe to return blood bags to refrigerator for reissue or if blood must be discarded

18. Increase Patient Safety • “Bacterial contamination of blood components is the most frequently reported cause of transfusion-related fatalities reported to the FDA” – Lab Medicine • “The blood bank or transfusion service shall have methods to limit and detect bacterial contamination in all platelet components” - AABB Blood Temp ensures that bacteria growth due to elevated temperatures has not compromised blood during storage, transportation and distribution Sources: http://labmed.ascpjournals.org/content/35/10/616.full.pdf http://asheducationbook.hematologylibrary.org/content/2003/1/575.full?sid=6490eff7-b721-4045-acb3-c35b7f367383

19. Ensure Regulatory Compliance Blood Temp provides auditable proof that your blood has been stored, transported and reissued properly and according to relevant regulatory standards.

20. Blood Life Cycle with Blood Temp Blood is discarded if the cold chain was not maintained properly After donation, blood is stored in a refrigerator Blood is moved from a refrigerator to the operating room or emergency room Blood Temp indicates if blood is safe to return to refrigeration for reissue

21. Blood TempBenefits Accuracy Easy to Read and Use Field-armable Clear indication when armed (yellow to green) Clear indication when breach (white to blue) • Temperature accuracy of +1°C • Aluminum backing acts as a conductive surface for greater accuracy in monitoring core blood temperature • No false activations from human handling Quality Traceability • Certificate of conformance with every shipment • Heat-sealed to prevent bleeding • Tamperproof • Splash / moisture-resistant • Unique identifiers assist tracking • Product is lot-traceable

22. Key Specifications

23. How Blood Temp Works Activated Not Activated

24. For additional informationemail info@shockwatch.comor visit www.shockwatch.com