Opening of Bids - Eight Cardiac Monitors Defibrillators - Physio-Control, Inc. - Part 2

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Full Energy Biphasic 360 Joule Technology Clinical Evidence 1. A large volume of published data now exists on biphasic defibrillation. It should be referenced when evaluating proven performance. 2. The data shows that at the same low energy biphasic shocks„ the most widely used defibrillation waveforms (BTE and RBW) have the same conversion rates from 501 to 200J,e-11 3. The data also shows that higher energy biphasic waveforirls are associated with higher conversion rates for VF/pVT and AF.' 4•"' 4. The 2010 and 2015 AHA Guidelines state full energy biphasic 360J is safe for patients."-14.11 High peals current is a primary cause of myocardial injury." Biphasic waveforms use as much as 40% less current than monophasic waveforms. Published clinical performance • Early manufacturer biphasic studies were done in EF labs on non -critical, short duration VF patients. All showed high conversion. rates at lower shock energies, But, biphasic performance in real -world cardiac arrest patients matters more. • The Physio-Control biphasic waveform (BTE) has been studied in nearly 2X as many cardiac arrest patients as all other manufacturers' biphasic waveforms combined, across a wide range of impedances.* Lowy energy biphasic 50J to 200J: clinical equivalence 100 • From 50J to 200J, five clinical cardioversion studies showed that at the same low energies, biphasic waveforms had the same v so conversion rates. 1z a • Three studies compared the Physio-Control BTE (LIFEPAK 12) and ° 60 ZOLL RBw (M Series") waveforms.e-le, • Two studies compared the Philips BTE (MRx) and ZOLL RBw b 40 (M Series and R Series"') waveforms.11,12 20 • For each study; same low energies = same conversion rates Full energy biphasic 3601s clinical advantage Iiini, Neal, Alatawwi """ 501 1031 15011 200,I • Clinical studies (VF and AM show protocols with escalating energy to full energy 360J improves conversion rates for difficult -to -defibrillate patients, 1.4 No clinical (human) evidence exists showing low energy (1501 to 200J) from any monitor/defibrillator provides equivalent or superior conversion rates when compared to full energy biphasic 360J, The only randomized,. triple -blinded Conversion rate were lower when 200J Conversion rate probability increased dosing comparison showed higher was repeated for recurrent VF/pVT. All in a subset of VF/pVT patients who conversion rate for VF/pVT when were eventually converted with 360J,2 received shocks at each energy dose, escalating to 360J vs. a fixed protocol.' 3601 had the highest cumulative rate.' 100 so G N 20 U 150.1 1501 15W 2001 30011 3601d BTE fixed HTE escalating 200, 20DJ 360J P' ;Shoc'k..._ 2ne shock 3'"a shock 2001 300J 360J "I`hese data ralrreswit the cuhnulative ournber oaf cardiac arrest patients io whonx the VF termination efficacy (using the established def.niticai of "rennoval or VF for 2 5 seconds') or spet,`iRc biphasic waveforms and energy levels has been reported in published papers describing either randomized or cohhsecutive case series of OHCA or IHGA patients. Included are papers that report. a VF termination rate For at least one of 1 i firstshocks or 2) all shocks. 0