Technology Overview – Temperature Sensitive Labels For RBC Minimizing Loss and mitigating risk using Timestrip temperature indicators Dan Hafen Director of Sales & Marketing 11652 Custer Rd #110 Suite 252 Frisco, TX 75035 Phone: (214) 263 -5793 Email: dan@timestrip. com LEGAL CONFIDENTIAL: The information in this slide deck and in any attachments herewith may contain information which is legally privileged. It is intended only for the attention and use of the named recipient. If you are not the intended recipient, you are not authorized to retain, disclose, copy or distribute the message and/or any of its attachments. www. timestrip. com
About Timestrip Founded Headquarters Solutions 2003 London, England Time Indicators Temperature Indicators www. timestrip. com
Give Blood www. timestrip. com
Blood Bag Temperature Indicators • Adhesive tags that display color change • Designed to alert when blood bag exceeds 10 C • Correlates with core blood bag temperature www. timestrip. com
Simple Regulatory Requirements • Blood storage between 1°C to 6°C • Not to exceed 10°C when transported • 30 -minute rule – Blood components may be held at ambient temperature for no longer than 30 minutes www. timestrip. com
Customer Requirements • • Easy to switch on Easy to apply / handle Monitors core blood temp (not air temp) Display breach when blood core temp rises above 10 C • Easy to interpret (regardless of language) • Small and discreet www. timestrip. com
Timestrip Blood Temp 10™ Easily and cost effectively communicates elevated blood bag temperature breaches. • Single use, single temperature threshold indicators • Easy-to-read – clear and unambiguous • Accurate & affordable • Ensure best practices • Alert parties of potential product instability • Available in rolls for easy dispensing in highvolume scenarios Inert Activated Breached www. timestrip. com
Timestrip Construction Mask / Design Determines breach window layout Blister Housing Dye Solution Membrane Blister awaiting activation Dye travels through micro pores Aluminum Backing Derives greater core blood temp accuracy www. timestrip. com
How It Works Inert: liquid in bubble awaiting activation. Activated: blister squeezed, green indication of arming window confirms product activation Breach: liquid progresses and colors breach window blue www. timestrip. com
Timestrip Blood Temp 10 - Layout Activation Blister Product is inert prior to activation Breach Window Turns blue after temperature breach Indication of Arming Green when product is active Unique Serial Number On every product www. timestrip. com
Blood Bag Temperature Variations 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 Jakob Woisetschläger, Ph. D, Graz University of Technology, Graz, Austria). The image reflects variations in temperature at different locations of a blood bag as the contents warmed from refrigerated to ambient temperature. Johnson, Langeberg, Makuria and Sandler 2006 www. timestrip. com
Indicator Placement: 3. 7 4. 1 3. 9 3. 5 Digital thermometer temperature measurements of the contents of 5 U of RBCs. 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. The digital thermometer 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. Johnson, Langeberg, Makuria and Sandler 2006 www. timestrip. com
Application – Blood Bag Requirements Proper temperature control of the blood bag is required prior to Timestrip® Blood Temp 10 application: – Blood bag must be pre-chilled to refrigeration temperature (2°C/36ᵒF – 6°C/43ᵒF) – Select a location on the lower 1/3 rd of the blood bag where the greatest amount of blood is held – Wipe area to ensure that it is clean, oil free and moisture free www. timestrip. com
Application – Prior to Activation To show that the Timestrip® Blood Temp 10 is inert and not yet monitoring temperature: – The indication of arming window will be yellow with a green border – The Breach window will be white with a red border www. timestrip. com
Application – To Activate In order to switch the product to its activated status and begin monitoring temperature: – Indicators must in an environment above 10ᵒC/50ᵒF (no pre-conditioning is required) – Firmly squeeze the blister located on top of the indicator showing the symbol www. timestrip. com
Activation – Proof of Successful Activation To confirm that the Timestrip® Blood Temp 10 has been activated appropriately: – The indication of arming window will change from yellow to green – In the event that the indication of arming window does not immediately change green re-squeeze the blister firmly and confirm the change from yellow to green www. timestrip. com
Activation – Applying Timestrip 10 Immediately after following the proof of successful activation instructions: – Peel off the Timestrip® Temp 10 adhesive liner – Adhere the indicator to the prepared location on the blood bag and apply constant pressure for 3 -5 seconds to ensure successful adhesion quality www. timestrip. com
Activation - Complete To complete the process: • Immediately after activation and adhesion your blood bag is ready for standard use www. timestrip. com
How To Interpret Inert When the Timestrip® Blood Temp 10 is in a state of inactivity: – Indication of arming window will remain yellow with a green border – Breach window will remain white with a red border Inert Activated Breached www. timestrip. com
How To Interpret Activated When the Timestrip® Blood Temp 10 has been activated but the core blood bag has not experienced 10ᵒC/50ᵒF temperature abuse: – Indication of arming window will be green – Breach window will remain white with a red border Inert Activated Breached www. timestrip. com
How To Interpret Breached Whenever the core temperature of the blood bag breaches the 10ᵒC/50ᵒF an immediate indication of temperature abuse is recorded: – Indication of arming window will be green – Breach window will turn blue with a red border Inert Activated The breach window is irreversible and cannot be reset or changed Breached www. timestrip. com
Protect Against Blood Waste • Blood Temp 10 makes it possible to reissue blood which would otherwise be discarded • Establish a positive ROI www. timestrip. com
Estimated Return on Investment Est. total Blood Bags (Per Year) X 20, 000 Loss units X $300, 000 • • • Avg. replacement costs per unit X Timestrip unit cost = Conservative loss reduction rate using a Timestrip 25% Current yearly costs for replacement $ 300, 000 = $ 1. 20 x Loss units (Per Year) 1, 000 $300 20, 000 Current yearly costs for replacement = 5% 1, 000 Est. total Blood Bags (Per Year) Est. loss rate Total Timestrip investment $ 24, 000 = 25% decrease in loss equates to savings of $75, 000 Reducing your loss rate by 8% pays for total investment. A conservative 25% reduction more than triples your return. Not captured in current costs to customer (that may be reduced with monitoring program): • • • Administration fees Freight (if product cannot be salvaged in the field) Unhappy customers (customer service manpower) Recall / Audits / Regulatory Fines Potential Litigation www. timestrip. com
Increase Patient Safety • Bacterial contamination of blood components is the most frequently reported cause of transfusion-related fatalities reported to the FDA • “The blood bank or transfusion service shall have methods to limit and detect bacterial contamination in all platelet components” - AABB • Blood Temp 10 ensures that bacteria growth due to elevated temperatures has not compromised blood during storage, transportation and distribution http: //labmed. ascpjournals. org/content/35/10/616. full. pdf http: //asheducationbook. hematologylibrary. org/content/2003/1/575. full www. timestrip. com
Accountability – do we really need to manage it? www. timestrip. com
Drive Accountability • When handlers know that blood temperature is being measured, their performance is improved rapidly www. timestrip. com
Ensure Regulatory Compliance • Blood Temp 10 provides auditable proof that your blood has been stored, transported and reissued properly and according to relevant regulatory standards. www. timestrip. com
Blood Temp 10 Life Cycle Flow www. timestrip. com
Check List Reduce blood waste Increase patient safety Ensure accountability Regulatory compliance www. timestrip. com
Summary Specifications Details Monitored temperature 10ᵒC/50ᵒF Temperature accuracy 1ᵒC/2ᵒF Storage conditions Store in a cool, dark location Storage temperature of 22ᵒC/72ᵒF at 20 -80% RH Shelf life 2 years from date of manufacture Display Irreversible Size 30 X 19 X 0. 5 mm Blister height 2. 5 mm Certificate of conformance with every shipment www. timestrip. com
Summary Continued Feature Benefits Patented field activation Low cost shipping and storage requirements Indication of arming Yellow to green window coloration after blister push Indication of breach Clear and unambiguous Unit level serialization Allows for individual product tracking and tractability Highly accurate Tag-to-tag repeatability proven in both lab testing and real world applications Aluminum backing Acts as a conductive surface to gain greater accuracy from core blood bag contents Handling No false activations from human touch Splash/moisture proof High moisture does not affect product stability, accuracy or structure Customization Temperature & design flexibility www. timestrip. com
Questions / Comments www. timestrip. com
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