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HomeMy WebLinkAboutOpening of Bids - Eight Cardiac Monitors Defibrillators - Physio-Control, Inc. - Part 2irranty US/Canada/Latin America/South Ameri'ca Subject to the limitations and exclusions set forth below, the following Physio-Control products which are purchased from authorized Physio-Control representatives or authorized reseflers for use in the United States of America, Canada, Latin America and South America and are used in accordance with their instructions, will be free from defects in material and workmanship appearing under normal service and use as defined below, Eight Years: Now LIFEPAK CR" Plus automated external defibrillator and internal battery system Five Years: a New LIFEPAK' 15 monitor/defibrillator series,, used in clinic and hospital settings exclusively (with no use in mobile applications) * New LIFEPAK 12 defibrillator/monitor, used in clinic and: hospital settings exclusively (with no use in mobile applications) Two Years:! CodeManagement Module'" for use with the LIFEPAK 20/2,Oe defibrillator/monitor One Year: * New LIFEPAK 15 monitor/defibrillator series, which includes use in out -of -hospital and mobile applications * New LIFEPAK 12 dofibrillator/rnonitor series, which includes use in out -of -hospital and mobile applications * RELl" LIFEPAK 12 defibrillator/monitor series a New LUCAS" Chest Compression System a Now LIFEPAK 500T trainer o New LIFEPAK CR-T trainer 0401111111103M * Masirno" SET SP02 only patient cables and reusable sensors 90 Days: CHARGE-PAK Charging Unit (external system) for LIFEPAK CR Plus defibrillator 30 Days: * Internal paddles and internal paddle handles * New LIFEPAK 20 defibrillator/monitor family of products, used in clinics and hospital settings exclusively (with no use in mobile applications) * New LIFEPAK 1000 defibrillators s New LIFEPAK EXPRESS automated external defibrillator and internal battery system Is New Trainer 1000 trainer * Internal Battery System for LIFEPAK 20 defibrillator/monitor family of products o Battery charging systems and power adapters 9 All batteries and battery pales, excluding CHARGE-FAKT111 Charging Unit * Masimo SET'' Rainbow' patient cables and reusable sensors 9 New TrueCPR` Coaching Device @ Installed customer repair parts * All other product accessories (continued on back) Limited warranty time Ilmits begin on the date of delivery to the First Owner' Physio-Control warrants neither error -free nor interruption -free performance. The sole and exclusive remedy of the First Owner Linder this Limited: Warranty is repair or replacement of defective material or workmanship at the option of Physio-Control, To quality for the repair or replacement, the product must have been continuously owned by the First Owner and not have been repaired or altered outside of an authorized Physio-Control factory in any way which, in the judgment of Physio-Control, affects its stability and reliability. The product must have been used in accordance with applicable operating instructions and in the intended environment or setting. The product must not have been subjected to misuse, abuse or accident, Physio-Control, in its sole discretion, will determine whether warranty service on the product will be performed in the field or through ship - in repair, For field repair, this warranty service, will be provided by Physio-Control at the purchaser's facility or an authorized Physio-Control facility during normal business hours. For ship -in repair, all products and/or assemblies requiring warranty service should be returned to a location designated by Physio-Control, freight prepaid, and must be accompanied by a written, detailed explanation of the claimed failure. Products repaired or replaced under this warranty retain the remainder of the warranty period of the repaired or replaced Product, Except for the Limited Warranty provided above, PHYSIO-CONTROL MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOMER OR OTHERWISE, THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. PHY&O-CONTROL IS NOT LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF BUSINESS OR PROFITS) WHETHER BASED ON CONTRACT, TORT, OR ANY OTHER LEGAL THEORY ANY LEGAL ACTION ARISING FROM THE PURCHASE OR USE OF PHYSIO-CONTROL PRODUCTS SHALL BE COMMENCED WITHIN ONE YEAR FROM THE ACCRUAL OF THE CAUSE OF ACTION, OR BE BARRED FOREVER. IN NO EVENT SHALL PHYSIO-CONTROUS LIABILITY UNDER THIS WARRANTY OR OTHERWISE EXCEED THE GREATER OF $50,000 OR THE PURCHASE PRICE OF THE PRODUCT GIVING RISE TO THE CAUSE OF ACTION. Products are warranted in conformance with applicable laws. If any part or term of this Limited Warranty is held to be illegal, unonforceablE or in conflict with applicable law by any court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shali be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. Some geographies, induding certain US states, do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This Limited Warranty gives the user specific legal rights. The user may also have other rights which vary from state to state or country to country. 1 First Owner means the first purchaser or lessee of the products listed above, directly from Physio-Control, through a Phys9o-Control corporate affiliate, or from an authorized Physio-Control resdier, and includes the invoiced purchaser's corporate affiliates, and their respective employees, officers and directors. I'lly'do cool of will Ira ss thlol Warl ulful'old by I'llird NIrty MaIlLifactureis, 1-:or ful I I ior informadw, plea so col It ac I P I lysio-col I I ro I M 1300.442.11/12 (U.S), 800.895.5896 i ada) 01, visit our vvebsite, at www. I) I iysto-cori I il II Physio-Control Headquarters PfIyslo-Control Canada 11811 Willows Road NE P iyslo-Control Canada Sales, Ltd, R udn iond. WA 98052 /111 Syntex Dri;ve, 3rd Floor" wvlmphyrlo-control (:Orr Mississauga, ON Customer Suppm t 1.5N 8G3 R O. Box 97006 Canada Redmond, WA 98073 "61 froo 800 895 5B96 Toll free 800 442 1142 Fax 866 430 f, 115 Fax 800 426 8049 ,02016 Physio-Control. Inc, All names herein are tradewarll or oegjsleied trademarks of their respective owners, l the. Radical logo, Rainil and SET are registered tradewaiks of Mismio Corporation. GDR 3315920 6 Physio-Cointr�ol, Inc. Returned ProdUCt POHCY If Customer desires to return a purchased product, Customer must call its local Physio-Control representative or the Physio-Controt regional sales office for information on credit or replacement of any purchased and non -expired product. A Returned Material Authorization (RMA) number will be provided and must be clearly identified on the carton of any returned product, Customer must return the product to Physio-Control in its original packaging, unopened, and undamaged, except for product that was received in a damaged condition or as otherwise authorized by Physio-Control, which product may be returned in its existing condition. Physio-Control will not accept the return of a non -defective and conforming product ff Customer breaks the security seat on the product. Physio-Control will provide an RMA and accept the return of any product under any of the following circumstances: a) Physlo-Control shipped the product in error; b) Customer received the product after the product"s expira6on date; G) Customer received the product in a damaged condition; cl The product is recalled and must be removed from the market,- or e) Physio-Control spedfically authorizes the return of the product (a 15% restocking fee may apply). Product must be returned within 30 working days from the date the Customer receives the product or within 30 working days from the date the Customer receives notice of recall, if applicable. Upon receipt of a properly returned product, Physio-Control will apply a full credit to Customer's account or provide replacement. Customer is advised that product returned without an RMA number, or not otherwise authorized, will not be accepted and will be returned to Customer at Customer's expense. For Nutter information, please cointart Physio-Controll at 800.442.1142 or visit our viehslte at www,pliyslo.-coipii[i,ot,cloi,n. �2010 Nysio-Gofitfol, Inc, 11811 Willows Rd NE, Redwood, WA OB052 USA All Oghts reserved. ON '3""'r A CERTIFICATE OF LIABILITY INSURANCE L1AT 0(1121122018 Y) THIS CERTIFICATE IS ISSUED AS A MATTER OF INFORMATION ONLY AND CONFERS NO RIGHTS UPON THE CERTIFICATE HOLDER. THIS CERTIFICATE DOES NOT AFFIRMATIVELY OR NEGATIVELY AMEND, EXTEND OR ALTER THE COVERAGE AFFORDED BY THE POLICIES BELOW. THIS CERTIFICATE OF INSURANCE DOES NOT CONSTITUTE A CONTRACT BETWEEN THE ISSUING INSURER(S), AUTHORIZED REPRESENTATIVE OR PRODUCER, AND THE CERTIFICATE HOLDER. IMPORTANT: If the certificate holder is an ADDITIONAL INSURED, the policy(ies) must have ADDITIONAL INSURED provisions or be endorsed. If SUBROGATION IS WAIVED, subject to the terms and conditions of the policy, certain policies may require an endorsement. A statement on this certificate does not confer rights to the certificate holder in lieu of such endorsementis). PRODUCER AOn Risk services central, Inc. Grand Rapids MI Office CONTACT PHONE E FAX JAIC. No. (61S) 45b-5366 IAlC No.):..(616) 456-7451 E-MAIL ADDRESS: 50 Louis street NW suite 200 INSURER(S) AFFORDING COVERAGE NAIC # Grand Rapids MI 49SO3 USA INSURED INSURERA: Old Republic insurance Company 24147 INSURERB: 5trvker Corporation & subsidiaries 2825 Airview Boulevard INSURER C: Kalamazoo MI 49002 USA INSURER D: INSURER E: INSURER F: n nWI=0AnI=Q r'FRT€FIC6TF NIIMRFR• h/i III/IIIl'l[Ia9}i KrVINIUN NL1Mtll'K: THIS IS TO CERTIFY THAT THE POLICIES OF INSURANCE LISTED BELOW HAVE BEEN ISSUED TO THE INSURED NAMED ABOVE FOR THE POLICY PERIOD INDICATED. NOTWITHSTANDING ANY REQUIREMENT, TERM OR CONDITION OF ANY CONTRACT OR OTHER DOCUMENT WITH RESPECT TO WHICH THIS CERTIFICATE MAY BE ISSUED OR MAY PERTAIN, THE INSURANCE AFFORDED BY THE POLICIES DESCRIBED HEREIN IS SUBJECT TO ALL THE TERMS, EXCLUSIONS AND CONDITIONS OF SUCH POLICIES. LIMITS SHOWN MAY HAVE BEEN REDUCED BY PAID CLAIMS. Limits shown are as requested LTR TYPE OF INSURANCE INSD WVO POLICY NUMBER MMIDDIYEYYY POLICY EXP MWQDNYYY LIMITS A X COMMERCIAL GENERAL LIABILITY MWZY 311141 EACH OCCURRENCE $ 5, 000, 000 CLAIMS -MADE X❑ OCCUR UAMAG O RENTED PREMISES Ea occurrence $500, 000 MED EXP (Any one personl Excluded PERSONAL & ADV INJURY $2 , 000, 000 GEN'LAGGREGATE LIMIT APPLIES PER: GENERALAGGREGATE $5 , 000, 000 X POLICY ❑ PRO ❑ LOC JECT PRODUCTS-COMPIOPAGG $5,000,000 OTHER: ''A AUTOMOBILE LIABILITY MWTB 312744 02/01/2018 02/01/2019 COMBINED SINGLE LIMIT Ea accident $2 , 000, 000 BODILY INJURY ( Per person) X ANYAUTO BODILY INJURY (Per accident) OWNED SCHEDULEO AUTOS ONLY AUTOS PROPERTY DAMAGE WEREDAUTos NON -OWNED Per accident ONLY AUTOS ONLY X Phys-OmgoSeEF lost UMBRELLALIAB OCCUR EACH OCCURRENCE AGGREGATE EXCESS LIAB CLAIMS -MADE DED I RETENTION A WORKERS COMPENSATION AND MWC 312743 00 027672618 02 01/2019 X PERSTA7UTE RH- EMPLOYERS' LIABILITY ANY PROPRIETOR I PARTNER i EXECUTIVE YIN A05 MWXS 312745 02/01/2018 02/01/2019 E.L. EACH ACCIDENT $2 , 000 , 000 A OFFICERIMEMBEREXCLUDED? (Mandatory in NH) NIA Excess WC -- MI E.L. DISEASE -EA EMPLOYEE $2 , 000 , 000 If yes, describe under DESCRIPTION OF OPERATIONS below F.L. DISEASE -POLICY LIMIT $2 , 000 , 000 DESCRIPTION OF OPERATIONS! LOCATIONS I VEHICLES (ACORD 101, Additional Remarks Schedule, may be attached if more space Is requiredl Physio-Control, Inc. and its affiliated companies are named under the referenced policy(s). Evidence of Coverage CERTIFICATE HOLDER CANCELLATION SHOULD ANY OF THE ABOVE DESCRIBED POLICIES BE CANCELLED BEFORE THE EXPIRATION DATE THEREOF, NOTICE WILL BE DELIVERED IN ACCORDANCE WITH THE POLICY PROVISIONS. Physio-Control International, Inc.; AUTHORIZED REPRESENTATIVE Physio-control, Inc. 11811 willows Road NE Po Box 97006 Redmond WA 98073 USA l 01988-2015 ACORD CORPORATION. All rights reserved. ACORD 25 (2016103) The ACORD name and logo are registered marks of ACORD Section 3 Product Information uj "u, L) 0cod a. co 2 � ol Lr) P� B. �o 10 4, '0 OR �aa bb 0 o a, LO W bo 0 bO 4. Id Lo P P, C) m L) 'd > P PQ w cam. w CO 0 0 48 4.. a) 4y > 0 106 Cf Cf) 'o, 'd 4q) 19 q 0 Z qs '0 0 12 - Id ILOI w 0 > P, V) ro 'o 0 > In 0 (d 0 0 Q e = CD to LO 41 0 50, CY) 2 "4 0 gi V) 0 LO co I'd 0 4014 4 0 LO > WO \ � k k - � ( % \ §\ \ % 2 ) / ! \) 7 o \\ § 3 + Q a 71 Product Information Physio-Control analyzed the City of South Bend's medical equipment needs and propose the following model to enhance the quality and functional requirements set forth by the City in the Notice to Bidders - Eight (8) More or Less Cardiac Monitors/Defibrillators, The UFEPAK'�) '15 Monitor/Defibriflator The LIFEPAK 15 monitor/defibrillator is the device of choice for Advanced Life Support teams who want the most clinically innovative, operationally effective and durable device available today. Built as an upgradeable �platform, the (LIFEPAK 15, with the latest version of software and hardware, offers sophisticated clinical technologies with a rich array of features — like the most powerful escalating energy available (up to 360J), and advanced monitoring parameters for your most critically ill patients.. The LIFEPAK 15 is the gth generation of monitor/defibrillators from Physio-Control, dating back 50 years to the first LIFEPAK, which was the first portable defibrillator designed for EMS. Why the UPEPAK 15 is your best solution: Easy to use — Because nothing can be in the way of your care teams and your patients. Whether treating critically ill patients, exporting data through the cloud to ePCR platforms, or transmitting a 12-Lead ECG to the hospital, Physio-Control understands the importance of your crews treating their patients — not the monitor. That's why everything about the LIFEPAK 15 is designed to maximize your interaction with the patient, and optimize your interaction with the device so that critical time is not wasted. • See the screen clearly with an 8.4-inch anti -reflective, color display with one touch to switch to high -contrast SunVue TM mode for quicker, easier viewing at all angles and the best full - glare view in the, industry • Access all key functionality with a single button-puish - critical therapy controls are single function, highly visible, forward facing, and clearly labeled • The Speed Dial allows for rapid screen navigation and energy selection. There are no complicated soft keys or submenus for basic therapy or monitoring functions. • Dual battery system automatically switches to the second battery if the first becomes depleted for up to 6 hours of uninterrupted power All cables, connectors, and the 100mm printer are front -facing for quick, easy access without unnecessary delays Know it's always ready to go with a daily 3 a.m. self -test that alerts you to possible issues before you experience them in the field, and asset management through the LII;ENET® System Resuscitation Results Matter. Your patients deserve the best possible chance to survive sudden cardiac arrest. Some of the highest -performing EMS systems in the world have driven better outcomes using Physio-Control's Resuscitation Systems of Care, and we would be proud to call City of South Bend our partner in this effort. Our experience has taught us that resuscitation is more than just a single tool, but rather a collection of tools in a resuscitation toolbox that 1) helps rescuers perform optimal chest compressions in any environment, 2) delivers maximum biphasic energy levels (up to 360 Joules) for higher conversion rates, and 3) provides rapid CPR data movement to quickly debrief crews while the code is still fresh in their minds. Proven CPR guidance and post -event review/crew feedback • Metronome guidance and voice prompts that are proven to help rescuers use correct timing. Hear guidance more clearly with ClearVoiceTM technology, even in noisy environments • Only device with cprMAXT^" Technology that minimizes pauses before shock when in AED mode which increases hands-on time to increase the chance of shock success. • MicrostreamTM1d capnography monitors EtCO2 levels for a patient -focused physiological assessment of CPR quality. AHA 2015 recommends the use of EtCO2 "...to monitor and optimize CPR quality, guide vasopressor therapy and detect ROSC. (Class Ilb, LOE C-EO, 5445)" • The only device that acquires CPR data for both pediatric and adult patients through our standard defibrillation electrodes without the need for additional sensors or specialty electrodes that add to the total cost of ownership. • Simple, one -button transmission of CPR and ventilation data directly to CODE-STAT for post -event review and rapid feedback to care teams, which has proven to be a powerful tool in improving CPR quality and resuscitation system performance. • Create more complete documentation for airway management by saving data from all displayed monitoring channels, including EtCO2 and enable continuous improvement in airway management during post -event review with automatic ventilation annotation that provides more detailed information about ventilation rates using CODE-STAT Data Review Software. Offers the most powerful escalating energy available, up to 360J • No commercially available defibrillator on the market offers equivalent strength to full energy, 360J biphasic offered by Physio-Control LIFEPAK defibrillators for both AED and manual defibrillation • Published clinical data demonstrate protocols with escalating energy to 360J improves conversion rates for difficult -to -defibrillate VF and AF patients compared with lower energy shocks • Multiple biphasic vs biphasic comparison studies show low energy is not equivalent to full energy, regardless of how current (A) alone is managed. To date, there are no peer - reviewed published data that demonstrates a lower energy shock is more (or as) effective than a higher energy shock • The science shows that no individual characteristic of any biphasic waveform determines conversion rate. The combined total of a shock's characteristics (energy), determines conversion rate. Shock energy (J) is the therapeutic dose that includes multiple waveform characteristics (current, voltage, and duration). Rapid Data Movement — Your Key to Better Outcomes All LIFEPAK 15 device data moves along the LIFENET System cloud, and our customers choose where it goes and who is authorized to view it. As your partner, our Connected Medicine team will work with you to accelerate, deploy, implement and support data collection, movement and analysis tools to meet your needs and maximize your performance objectives. Specifically the LIFEPAK 15 is cloud -connected for four reasons: 1. Transmit emergent patient data (i.e. 12-lead ECG) to the hospital. • The LIFEPAK 15 uniquely provides users with a simple 3-step transmission process. 1) Press the TRANSMIT button, 2) Select your hospital, 3) Select SEND. • The LIFEPAK 15 is the only commercially available monitor defibrillator that allows for automatic transmission of 12-Lead ECGs to the hospital, eliminating the need to push even a single button. • Eliminate the potential for miscommunication of transmission status. Only the LIFEPAK 15 provides 2-way communication with the hospital's LIFENET System. When the LIFEPAK 15 displays and prints that the transmission is complete, this means the 12- lead has been received by the hospital. • We've all experienced that cellular coverage can be intermittent in certain areas as we travel down the road, so the LIFEPAK 15 will attempt to transmit three times. If it fails all three times, the LIFEPAK 15 displays and prints that the transmission has failed, alerting the user to try again. • The LIFEPAK 15 is the only device capable of transmitting custom event data for any emergency, such as STROKE or SEPSIS. Now EMS crews can alert the hospital's LIFENET System of inbound stroke or sepsis patients. Hospital, in turn, can use LIFENET to alert multiple care -teams, such as neurology and pharmacy. • The LIFEPAK 15 is the only device that transmits all vital signs with every transmission. Physio-Control believes in providing hospital care teams with the most information possible. 2. Rapid export of monitor data to cloud -connected ePCR platform • Time is everything in an emergency, seconds truly count. The LIFEPAK 15 has the ability to efficiently compress and transmit data at high speed and the ability to transmit data at various times during a call. While most ePCR transmissions are completed at the end of the incident, the LIFEPAK 15 allows the provider to transmit information at any time. • The LIFEPAK 15 uniquely provides users with a simple 3-step transmission process to ePCR platforms 1) Press the TRANSMIT button, 2) Select your ePCR, 3) Select SEND. 3. Export CPR quality data to CODE-STAT software for QAIQI and rapid feedback to the crews while the code is fresh in their minds CODE-STAT software simplifies post -event review and enables ongoing provider education. When it comes to quality improvement, CODE-STAT enables your teams to measure, review, report, and repeat -.. with the goal of optimizing team performance over time. AHA Consensus Statement recommendations on CPR quality suggest maintaining "continuous quality improvement on provider, team and systems levels." CODE-STAT software helps automate this process and provides CPR quality measures on demand or automatically during the device self -check. CODE-STAT software gives you quick access to relevant, high -quality data —including compression fraction (hands-on time), compression rate, longest pauses and time elapsed before first shock. That means it's simpler to focus on areas of improvement, so your code team is better prepared for the next event. Continual improvement leads to better survival rates and better neurological outcomes for your patients. The LIFEPAK 15 uniquely provides users with a simple 3-step transmission process to ePCR platforms 1) Press the TRANSMIT button, 2) Select CODE-STAT, 3) Select SEND. 4. Export device health and readiness data to your LIFENET Asset Management System • At Physio-Control we believe it is important for you to know about monitor issues before they are used on patients. That's why the LIFEPAK 15 is the oo device that automatically transmits the results of its daily self -test to your LIFENET Asset Management System. • The LIFEPAK 15 is the only device that automatically notifies your designated team about self -test failures. Your EMS Equipment Manager and your Physio-Control Service Representative can be notified by email or text message and respond to your device before your device responds to the next call. • LIFENET Asset conveys the battery status and configuration of every LIFEPAK 15 monitor in your fleet. • LIFENET Asset stores service reports for each LIFEPAK 15 monitor in your fleet, providing you with easy to access documentation of your LIFEPAK service reports. Uses a leading 12-lead ECG algorithm Reliable 12-lead ECGs are invaluable in assessing your patients' conditions and providing valuable information to hospital care teams. That's why the LIFEPAK 15 uses a 12-lead analysis algorithm that's been developed and continuously improved over the years by a team of world-renowned ECG researchers to optimize its utility in the EMS setting. • The LIFEPAK 15 incorporates the trusted, proven University of Glasgow 12-Lead ECG Analysis Algorithm, which has almost 40 years of history and is widely considered one of the top ECG interpretive algorithms in the world - backed by decades of refinement and numerous clinical studies • The only commercially available monitor/defibrillator that continuously monitors all 12-leads in the background and alerts medics to changes using the ST-Segment trend monitoring feature • The Glasgow algorithm rules out common imposters of STEMI in the presence of left bundle branch block by using the Sgarbossa criteria — recommended by the 2012 ESCIACCFIAHANVHF Third definition of myocardial infarction • The only commercially available monitor/defibrillator that includes pediatric interpretive statements for patients under 18 years of age all the way down to pne day old • Follows AHAIACCFIHRS recommendations for STJ measurement at the J point for STEMI, and prints individual STJ measurements for all 12-leads to reinforce the medic interpretation • Includes criteria for Brugada pattern, a non-ischemic cause of ST elevation Designed to be LIFEPAK TOUGHTM At Physio-Control, we believe LIFEPAK devices should live up to the highest expectations of those working in the harshest of settings. • Ergonomically designed handle has built-in shock absorbers for cushion and fits two gloved hands for easy hand off. • Corner guards protect the most vulnerable parts of the device • Dual layer screen has anti -scratch coating • Tested to withstand drops on six sides onto a steel surface, without bags, and a 5 lb steel impact weight dropped on each all sides of the robust therapy connector • A circular shield surrounds the ECG connector slot for a more solid cable connection that helps prevent cable migration and pin breakage • A circular shield surrounds the ECG connector slot for a more solid cable connection that helps prevent cable migration and pin breakage • Internal design capable of withstanding severe impacts and extreme vibration str ker i Full Energy Biphasic 360 Joule Technology Physio-Control LTFFPAI O monitor/defibrillators Key definitions Monophasic waveform 40 ...Peak Current nionopliasic waveform (older, single direction 30 energy delivery, higher R peals current) 20 Peak Current biphasic waveform Biphasic waveform 1° (modern, bidirectional o energy delivery, less 10 peak current) • Biphasic 'Truncated U ' 15 'r 20 Time (ms6 Exponential- BTE (dynamic current and duration, fixed shape) • Rectilinear Biphasic Waveform- RBW (dynamic current and shape, short fixed duration) 11 Energy expressed in joules (combined metric of current and voltage over time) • Joule (unit of energy (J), 1 amp passing through 1 ohm for 1 sec) • Current (flow of electricity measured in amps (A)) • 'Voltage (electromotive push or force measured in volts (V)) • Duration (interval of time measured In milliseconds) • Impedance (resistance to flow of current measured in ohms) Clinical study (human population) Experimental study (animal population) Biphasic waveforms and maximum programmed settings' s Time (ms) Optimizing conversion rates Biphasic research has provided direction on optimizing conversion rates for the 5-11% of cardiac arrest patients who are difficult-to-defibrillate,',z The more efficient biphasic defibrillation waveforms still leave room to improve conversion rates." • No singular electrical characteristic (current„ voltage or duration) of any biphasic waveform determines conversion rate., • The therapeutic defibrillation dose is a defined set of electrical characteristics over a defined time, measured as energy.' • Published clinical data strongly points to an association between higher biphasic shock energy Uoulcs) and higher conversion rates for VF"/pVT and AF.1-1 Shock Energy (J) 7 11hysio-Control ZOLL Philips LiFEPAK 15 X-Series' MRz *Bipliasic measurement's testing at 90 oluns with the Physio-Control LIFE PAK 15 Monitor/Defibrillator, 1OLL X- Series Monitor/Defibrillator and Philips MRx Monitor/ Def brillator.° Average human 'ianpadance range is approximately 70-80 ohms.' 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 Clinical Overview Biphasic clefibrilllation comparison These data represent the cumulative number of cardiac arrest patients in whom the VF termination efficacy (using the established definition of"re oval of VF for _> 5 seconds") of specific biphasic waveforms and energy levels has been reported in published papers describing either randomized or consecutive case series of oHHCA or IIICA patients. Included are papers that report a VF termination rate for at least one of 11 first shocks or Z) all shocks. Based on information available in the published literature as of March 201.8. **May deliver more energy than the E Series, M Series and ZOLL AEDs.zi,ee'rhis is less than the maximum energy delivered in LIFEPAK monitor/defibrillators and LIFE PAK AEDs. Clinical strategies to improve conversion rates The Critical Mass Theory is a meaningful conceptualization that can help clinicians improve conversion rates.' The goal is to depolarize as much of the myocardial tissue as possible at once, placing it into a repolarized, refractory state unable to re -propagate the electrical misfires that cause Vk/pVT. Two controllable factors can significantly impact this complex biological interaction. 1. optimize the size of the defibrillation field Higher energy (J) can increase a shock's myocardial coverage while less energy likely covers less. Data supports escalating to 3601 as a mechanism to maximize conversion rates.'.4,'a Suboptimal energy dose Myocardium not exposed to sufficient electrical field Closing point's • Science recognizes that no individual characteristic of a well - designed biphasic waveform determines conversion rate. The combined total of a shock's electrical characteristics (energy expressed in joules), determines conversion rate. • 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 50J to 240J. 2. Optimize the vector of the defibrillation field Suboptimal pad placements can also lower conversion rates. Escalating to 360J can compensate for these variations." Suboptimal pad placement, Myocardium not exposed to sufficient electrical field i�—. I Optimal lateral Published clinical data demonstrate protocols with escalating energy to 360J improves conversion rates for difficult -to -defibrillate VF and AF patients, No commercially available defibrillator on the market offers equivalent strength to full energy biphasic (360J) offered by Physio-Control LIFEPAX defibrillators for both AED and manual defibrillation. References 1. Walker G, Koster R, Sun C, at al. Defibrillation probability and impedance 12. Sautomauro M, Borrelli A, Ottaviano L, et al. Card ioversione elettrica change between shocks during resuscitation from out -of -hospital cardiac esterna in pazienti con fibrillazione atriale: confronto fratre d€fferenti arrest. Resuscitation, 2009;80:773-777. Forme di onda.Ital Heart JSuppl. 2004;1(5)36-43. 2. Koster R, Walker R, Chapman F. Recurrent ventricular fibrillation during advanced life support care of patients with prehospital cardiac arrest. Resuscitation. 2 0 0 8; 7 8: 2 5 2- 2 5 7. 3. Stiell I, Walker R, Nesbitt L, at al. Biphasic trial a randomized comparison of fixed lower versus escalating higher energy levels for defibrillation in out -of hospital cardiac arrest. Circulation. 2007;115:1511-1517. 4. Khaykin Y, Newman D, Kowalewski M, et al. Biphasic versus monophasic cardioversion in shock -resistant atrial fibrillation: a randomized clinical trial. Journal of Cardiovascular Electraphysiology, 2003;8(14);868-872. S. Tanker W.A. DEFIBRILLATION OF THE HEART. October. 1993, 6. Physio-Control Internal Testing of the LIFEPAK 15 Defibrillator Monitor-, Philips MRx Defibrillator Monitor, ZOLL X-Series Defibrillator Monitor, ZM7. 3333950 Competitor Waveform Recordings, Attachment A 7. Link M, Atkins D, Passman R, et al. Part 6: Electrical Therapies: Automated External Defibrillators, Defibrillation, Cardicversion, and Pacing 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Circulation. 2010;122; S706 -719. 8. Kim M, Kim S, Park D, at al. Comparison of rectilinear hiphasic waveform energy versus truncated exponential biphasic waveform energy far transthoracic cardioversion of atrial fibrillation. TheAmerican Journal of Cardiology. 2004;11(94):1438-1439, 9. Neat S, Ngarmukos T, Lessard D, et al. Comparison of the efficacy and safety of two biphasic defibrillator waveforms for the conversion of atrial fibrillation to sinus rhythm. The American Journal of Cardiology. 2003;92:810-814, 10. Alatawl F, Gurevitz O, White R, at al. Prospective, randomized comparison of two hiphasic waveforms for the efficacy and safety of transthoracic biphasic cardioversion of atrial fibrillation. The ,Heart Rhythm Society. 2005;4(2):382-387. 11. Deakin C, Connelly S, Wharton R, et al. A comparison of rectilinear and truncated exponential biphasic waveforms in elective cardioversion of atrial fibrillation: a prospective randomized controlled trial. Resuscitation. 2 0 € 3; 3(84):286-291. All claims valid as of March 2018. Physio-Control is now part of Stryker. 13, Stothert J, Hatcher T, Gupton C, et al. Rectilinear biphasic waveform defibrillation of out -of -hospital cardiac arrest. Prehospital Emergency Care. 2004; 8 (4(:388-392 14. Link M, Berkow L, Kudencliuk P, et al. Part 7: Adult Advanced Cardiovascular Life Support 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular. Circulation. 2015;132[suppl 21:S448, 15. Higgins S, Herre J, Epstein A, et al, A comparison of biphasic and monophasic shocks for external defibrillation. Prehosp Emerg Care, 20 00;4:305-3 t 3. 16. Martens P, Russell J, Wolcke B, at al. Optimal Response to Cardiac Arrest study: defibrillation waveform effects. Resuscitation, 2001;49:233-243. 17. Tsai M, Tang W, Castillo C, et al. Individual effect of components of defibrillation waveform on the contractile function and€ntracallular calcium dynamics of cardiomyocytes. Crit Care Mud. 2009;37:1-8. 18. Walker G, Melnick S, Chapman F, et al. Comparison of six clinically used external defibrillators in swine. Resuscitation. 2003;57:73-83, 19. Esibov A, Chapman F, Melnick S, at al. Minor variations in electrode pad placement impact defibrillation success. Prehospital Emergency Care. 2015; t-7. 20. Physio-Control, LIFEPAK 15 Defibrillator/Monitor, Operating Instructions. Publication Date: 07/2014, PN: 3314911-003. 21. ZOLL E-Series Operators Guide. REF: 9650-121-01 Rev. T. June, 2014. 22. ZOLL X-Series Operator's Guide. REF: 9650-001355-01 Rev. P. September, 2016. 23. Physio-Control Internal Testing of the LIFEPAK 15 Defibrillator Monitor, Philips MRx Defibrillator Monitor, ZOLL X-Series Defibrillator Monitor, 2017, 3333950 Competitor Waveform Recordings, Attachment B. For further information, please contact Physio-Control at 800.442.1142 (U.S.), 800.895.5896 (Canada) or visit our website at www.physio-control.com Physio-Control Headquarters 11811 Willows Road NE Redmond, WA98052 www. phy s io-co nt r ol. c om Customer Support P. 0. Box 97006 Redmond, WA 98073 Toll free 800 442 1142 Fax 800 426 9049 Physio control Canada Physio-Control Canada Sates, Ltd. 45Innovation Drive Harniltoa, ON L913 7LB Canada Toll free 800 895 5996 Fax 866 430 6115 0201B Physio-Control, Inc. All names herein are trademarks or registered trademarks of their respective owners. CDR 3336407_A I.- sEryker ,Evolution in ECG Interpretation 100001 University of Gl�asgo,w ECG analysis prograrr no 0 111111111,060 LIFEPAKO 15 rnonitor/defibrillator Key definitions STEMI (ST elevation myocardial ischemia/infarction) STJ level (ST level at J point, QRS end) STEMI imposter (non-ischemic cause of ST elevation) Sensitivity for STEMI (% of STEMI patients who got a STEMI interpretation) Specificity for STEMI (% of patients without STEMI who do not get a STEMI interpretation) False positive rate (% of patients without STEMI who got a STEMI interpretation, = 100% - specificity) Positive predictive value (% of STEMI interpretations that are actually STEMI; this is strongly affected by STEM11 prevalence in the population who get 12-leads 12-lead ECG interpretive programs are not created equal The Glasgow ECG analysis program has been used around the world and refined over 30 years.' It is considered to be among best -in -class by cardiologists.' The LIFEPAK 15 monitor/defibrillator currently uses Glasgow version 27.1," As a trusted EGG interpretive algorithm, the Glasgow program offers many leading clinical advantages and has proven performance for STEMI analysis." Published performance Published performance in hospital and prehospitat environments should be a standard expectation of any 12-lead EGG interpretation program. The Glasgow ECG analysis program has been well -studied in both clinical settings. • Four published articles on STEMI detection in prehospital use • Over 100 published articles on detection of arrhythmias and morphology abnormalities Tuscon data (Macfarlane 2004)�, 1,220 patients with chest pain N/A 98.5% 1.5% Tuscon data (Macfarlane 20071" 300 patients with chest pain 89% N/A N/A . . . ........ . — Denmark data (Clark 2010) 912 patients with AGS symptoms 78% 94% 6% Los Angeles data (Bosson 2017)8 44,611 patients wrth 12-lead ECGs 92,8% 98,7% 1.3% Note: Sensitivity and specificity for STEMI should not be cornpared between different EGG interpretive programs unless testing was done with the, same 12-fead ECG data set. Clinical advantages The Glasgow ECG analysis program incorporates key clinical features to assist clinicians with diagnostic assessment of patients with challenging fit -leads. • STEMI thresholds based on age and gender as recommended by the AHNACCRES01" • Measures ST level at the point for STEMI as recommended by the AHA/ACCF/ESCIO-11 • Uses Sgarbossa criteria for STEMI detection in LBBB as recommended by the AHNACCRESC"m "' • Provides interpretive analysis statements for adult and pediatric patients"' • Includes criteria for Brugada pattern, a non-ischemic cause of ST elevation Clinical advantages (coat.) Age and gender based STEMI thresholds • Age and gender affect normal STJ levels • Older men require less STJ elevation than younger men for STEMI • Women require less STJ elevation than men for STEMI • The AHA-recommended STEMI thresholds are based on age and gender data from University of Glasgow researchg�va J point measurement for STEMI threshold • The Glasgow program follows the AHA/ACCF/HRS recommendations for STJ measurement at the J point for STEMI111" • Measuring after the J point can result in overestimation of the true J point measurement for STEMI 0.2mV (2 mm) overeslicmaterl ST elevation J point i Sgarbossa criteria for STEMI analysis in left bundle branch block (LBBB) • LBBB can increase the risk of a false negative STEMI interpretation • LBBB is also a "STEMI imposter" and increases the risk of false positive STEMI interpretation • The Glasgow program uses Sgarbossa criteria to Book for STEMI when the patient has a LBBB'1' 12-lead ECG interpretive program comparison 12-lead ECG interpretive algorithm Pediatric interpretation _. ..._. LBBB criteria for STEMI ST measurement taken at the J point Published results fromtestingwith prehospital EGGS Adult and pediatric interpretive analysis • Infrequent use of pediatric 12deads makes pediatric interpretive analysis clinically valuable • The Glasgow program can be used for patients of any age down to newborns13 • EGG criteria for neonates, infants and children — Age -dependent bradycardia and tachycardia limits — Age -dependent conduction defect limits — Age -dependent right ventrucuiar hypertrophy — Age -dependent ST depression thresholds Brugada staternent • Brugada syndrome is an inherited genetic defect that increases risk for spontaneous VT/VF • It occurs in approximately 1 in 2,000 patients • A distinct coved -type ST elevation occurs in the right precord'ial leads • It is also a "STEMI imposter" and Increases the risk of false positive STEMI interpretation • The Glasgow program uses Brugada pattern criteria according to the Second Consensus Conference on the Brugada Sy ndromea,,a Glasgow v27.0 Inovise 121.. v1.00 DXL vPi-1100B Yes No Yes Yes No Yes Yes No Yes 4 studies 1 study No 12-lead comparison for a pedliatric patient Pediatric interpretation for a 10-year-old patient The Glasgow EGG analysis program gives an appropriate pediatric interpretation Namea IZI-ead 1 HR 100bpm Normal ECG "Unconfirmed" ID: 10/1612017 3:54:3$13M Sinus rhythm Patient ID: PR 0,128s ORS 0.098r, QT/Q`Fc. 0.324s/0.394S 'Age:p 10 Sex: M P-QRS-T Axes: 66115*42' 1 aVR i V1 I V4 }_J I It la L I V2 IV5 \T_jr A- lIII I aVF i V3 I V6 I F-1 x1 .0 .05-15OHz 25mm/sec LP15 bb Adult interpretation for the same 10-year-old patient • Same 10-year old pediatric patient, but taken after entering an adult age of 18 years • Entering an adult age for a pediatric 12-lead can produce inappropriate interpretative statements • Some EGG analysis programs are contraindicated for pediatric interpretation" Name:: ZLead I HR 100bpm Abnormal `ECG ,­Unconfirmecr' 10: 10/16/2017 2:55!21 PM Sinus tachycardia Patient ID: PR 0.128s QRS 0.098s Possible, right ventricular hypertrophy QT/QTc: 0.324s/0.394s Age: 18 Sex: M P-QRS-TAxes: 66'15'42' I aVRI V1 I V4 III i�L IV2 r iV5 IIII I aVF V3 I V6 x1.0 .05-150Hz 25mmtsec LP15 12-lead with interpretative statement for STEMI with LBBB * Glasgow EGG analysis program uses Sgarbossa criteria for STEMI detection in a patient with a LBBB Name: 12-Lead 1 HR 51bpm Abnormai ECG "Unconfirmed"' to: 11/17/2017 10: 15:2,9 AM ­* MEETS ST ELEVATION MI CRITERIA Patient to: PR 0,228s QRS 0.174s Sinus rhythm with PACs with 1st degree A-V block� Incident ID: QTIQTc: 0.532st0.517s Left bundle branch block Age: 53 Sex- M P-QRS-T Axes: 2'25'122' Interior ST elevation, CONSIDER ACUTE INFARCT aVR i vi V4 II avL j V2 t q V5 qtv\PP' ,V\ �A \ r �f JO V3 V6 x1.0.05-150Hz 25mm/sec LP15 12-lead with Brugada interpretative statement • The ST elevation is correctly attributed to the Brugada pattern Name: 12-Lead 1 ID; 11/16/2017 Patient ID:', PH 0.158s Incident ID: QT1QTc: Age, 73 Sex; M i P-QRS-T Axes: I f I aVR aVL I IaVF xl.0.05-150Hz 25mrn/sec. References HR68bpm Abnormal ECG -Unconfirmed" 2:56:00 PM ,Sinus rhythm OHS 0.150s Marked ST elevation - consider Brugada syndrome 0,398s/0,412s 'STjunctional depression is nonspecific 56"45W i j (V"G I V4 V2 , I V5 I V3 V6 - i II LP15 1. Macfarlane P, Devine B, Clark E. The University of Glasgow (Uni-G) ECG analysis program. Computers in Cardiology. 2005;32:451-454. 2, 'Willems ,I, Abreu-t..ima C, Arnaud P, et al. The diagnostic performance of computer programs for the interpretation of electrocardiograms. N Frlgl J Med. 1991;325:1767-73. 3. Glasgow 12-lead ECG Analysis Program: Statement of Validation and Accuracy. Redmond, WA: Physio-Control; 2009. 4, Glasgow 12-lead ECU Analysis Program: Physician's Guide. Redmond, WA: Physio-Control; 2009. 5. Macfarlane P, Browne U, Devine B, of al. Modification of ACC/ESC criteria I'or acute myocardial infarction. J FlectrocardiaJ. 2004;37(supp1):98-103. 6. Macfarlane P, Hampton D, Clark E, et al. Evaluation of age and sex dependent criteria for ST elevation myocardial infarct'orr. Computers in Cardiology. 2007;34;293-6, 7. Clark E, Sejersten M, Clommensen P, of al. Automated electrocardiogram interpretation programs versus cardiologists' triage decision making based ore teletransmitted data in patients with suspected acrlte coronary syndrome. torn J Cardiol. 2010;106.1606-702. 8. Etosson N, Sanko S, Stickney R, et al. Causes of prehospital misinterpretations of ST elevation myocardial infarction. Prerrosn E'merg Care. 2017;21:283-290. 9, Macfarlane R. Age, sex, and the ST amplitudo in health and disease. J Flectrocardiol. 2001;34(suppi):235-- 41. 10. Wagner G, Macfarlane P, Wellens hf, et al, AI-IA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: Part Vi: acute ischemial infarction. Circulation. 2009;11::062-70, 11 Thygesen K, Alpert J, ,Jaffe A, at al. Joint ESC/ACCF/AHA/WHF Trask Force. Third universal definition of myocardial infarction. Circulation. 2012.;126:2020-35. 12. Sgarbossa E, Pinsky S, Beni A, et al. Electrocardiographic,, diagnosis of evolving acute myocardial infarction in the presence of left bundle branch block. N Fngt ,l Med. 1096;334:481-7, 13, Macfarlane P, Coleman E, Devine B, of al. A new 12-lead ,pediatric ECG interpretation program. J Flcctrocardiot. 1990;23(suppl);76-8'11, 14. Antzelsvitch C, Brugada PP, Gorggrefe M, et al. Brugada syndrome: report of the second Consensus conference, Circulalion. 2005;111;659-70- 15. Inovise 12L intcrprative Algorithm Physician's Guide. (9650-001357-01 Rev.. C), Chelmsford, MA: 701-1- Medical Corp; 2015. AIII claims valid as of January 2018. Physio-Control is now part of Stryker. For further information, please contact Physio-Control at 800.442.1142 (U.S.), 800.895.5896 (Canada) or visit our website at www.physio-control.com Physio-Control Headquarters 11811 willows Road NE Redmond, WA 98052 www.physio-control.com Custorner Support P. 0. Box 97006 Redmond, WA 98073 ToH free 800 442 1142 Fax 600 426 8049 Physilo-Control Canada Physio-Control Canada Sales, Ltd. 45 Innovation drive Hamilton, ON L9H 7LB Canada Toll free 800 895 5896 Fax 866 430 6115 02018 Physio-Cooarol, Inc. All names herein are trademarks or registered trademarks of their respective owners. GDR 3335513,,-A f\(Z,}\�/: {,\ \^ $� $ \\\ \?� \ For Emergency Medical Services When you respond to emergencies, you need the most advanced monitor/ defibrill'ator operationsinnovation, andtoughness. The LIFEPAK 15 monitor/defibrillator delivers. Physio-Control defibrillators have set the standard for six decades, and the latest version of the LiFIEPAW 15 monitor/defibrillator raises the bar. As our most advanced emergency response monitor/defibrillator, the LIFEPAK 15 device balances sophisticated clinical technoGogies and supreme ease of use in a device that's tough enough to stand up to your most challenging environments. Evolving from its original platform, the 15 features temperature monitoring and external power to complement 360J of energy and 12-lead ECG transmission capability. And that means your team can be even more effective. A LIFEPAK device never stands on its own —and the LIFEPAK 15 monitor is no different. Physio-Control is committed to providing innovative solutions for emergency response care, from first responders to throughout the hospital. Out, products have helped save tens of thousands of five,s. We're proud to continue this work with the features in the LIFEPAK 15 munit of1defibrillator. L I F E PA K 15MON ITO R / D EFI BR I LIATO R The standard in clinical innovatiol The pioneer in portable defibrillation and monitoring technology, Physio-Control is committed to creating technologies and devices that change the way you provide emergency care. You can see the results in the latest version of the LIFEPAK 15 monitor/defibrillator, which sets the standard in innovation —yet again. 0 EM Advainced moriftoring parameters With more monitoring capabilities than any other monitor/defibrillator, the 15 gives you EtCO., with continuous waveform capture. Masimo' Rainbow' technology' elps you detect hard -to -diagnose conditions and improve patient care with noninvasive monitoring of carbon monox- ide, SpO, and methemoglobin. In addition, the 15 offers temperature monitoring — and like other data, you can transmNt it to other systems, trend it, or display for post -event review in CODE-STAT111 data revoew software. A,dvainred support for treating cardiac patients The 15 continuously monitors all 12 leads in the background and alerts you to changes using the ST-Segment trend monitoring feature, after acquiring the initial 12-lead. Additionally, STJ values are included on the 12-load printout to help you identify changes. The 15 an'so works soamlessly with the web -based LIFENET System 6,0, so you can automatically share cnfical patient data with multiple patient care teams. FUH energy up to 360 joules, for every patient who needs it The LIFEPAK 15 monitor/defibrillator features 360J Nphasic technology, which gives you the option of escalating your energy dose up to 360J for difficult -to -defibrillate patients, Why is this necessary? Recent studies have shown that refibrillation is common among VF cardiac arrest patients and that defibrillation of recurring episodes of VF is increasingly difficult. A randomized controlled clinical tHal shows the rate of VF termination was higher with an escalating higher energy regimen of 200J and over.' Proven CPR guidance and post event review The CPR Metronome in the LIFEPAK 15 monitor uses audible prompts to guide you without distracting vocal critique, A metronome has been a feature that has been demonstrated to help professionals perform compressions and ventilations within the recommended range of the 2010 AHA Guidelines. Post -event review of CPR data and defivedng feedback to the team has been shown to be effective in improving CPR quality in both hospital and out -of -hospital,"" And by transmitting code data directly to CODE-STAT Data Review software, EMS personnel can review CPR statistics and provide traiNng and feedback where it is most needed. Post -event review of CPR data and delivering feedback to the team has been shown to be affective in improving CPR quaRy in both hospital and out -of -hospital.'... ICI '' MONITtR/DEFIBRILIATOR The standard in operational effelctiveness. Flexible, connected and easy to use, the LIFEPAK 1' 5 monitor/defibrillator was designed based on the feedback and needs specific to working in the field. Mill rr°lode, LCit sicre:en with Sw ue"' ctispirty Switch from full -color to high -contrast SunVue mode with a single touch for the best full -glare view in the industry. A large screen (8.4 inches diagonally) and full -color display provide maximum viewability from all angles. FlexNe power, or Uorti Choose between external worldwide AC or DC power, or use the latest. Lithium -ion dual battery technology for up to six hours of power. The LIFEPAK 15 monitor's two -battery system requires no maintenance or conditioning, and allows you to charge batteries in the device. In addition, you can track the status and service Rife of your batteries using LIFENETT'Asset, part of the LIFENET System data network, Data connectivity The 15 collects code summaries and equipment status data along with critical clinical information as you treat patients. Using LIFENET Connect, part of the LIFENET System data network, the code summaries can be sent directly to your quality improvement team for review with CQDF-STAT Data Review Software. Your equipment manager can also view equipment status on the LIFENET System 5.0 using LiIIFENET Asset and alert you to any potential issues, i.tpgrftrtat e platform The 15 platform is flexible enough to adapt to evolving protocols and new guidelines, and can be upgraded as you're ready to deliver new capabilities. With more processing power and speed,. the 15 is designed to grow as your needs change„ heaping you avoid costly premature replacements, tten ion to rtetaH The LIFEPAK 15 monitor is designed based on field feedback to make it a more effective tool. The 15 has a larger handle for easier handoffs, an easy to clean keypad, and a common interface to the LIFEPAK 12 defibrillator/monitor that helps reduce training. Code ;ci iI'rN,'Iriti ; can be sent direcUy to your cjuaRy irnpro en Ie I tea[lrl for an/iew rruatih COD ,E3_C"/U Data I-tp=vew Sor[wafe. The standard in toughness. We believe LIFEPAK equipment should live up to the highest expectations of those working in the harshest settings. The 15 is LIFEPAK TOUGH, with improved ruggedness and durability you can rely on. Works when dropped, kicked, soaked or Wrty The LIFEPAK 15 monitor/defibrillator passes 30-inch drop tests, which is equal to failing off a cot or dropping it in transit. And with an IP44 rating, it doesn't matter how wet or dirty it gets, so you can keep working in steady wind, rain and other harsh environments, Toughened in side and out We heard from emergency response teams that they wanted a tougher device ---so we added a shock -absorbing handle, a double -layer screen that can take a beating from doorknobs and cot handles, and redesigned cable connections for confident monitoring and therapy delivery. Unmatched fieldservice The unit's self -checking feature alerts our service team if the device needs attention. Our on site maintenance and repair, access to original manufacturer parts, and highly trained, experienced service representatives give you the peace of mind that your LIFEPAK 15 monitor MI be ready when you need it,* Data connectivity LIFEPAK TOUGHT'd Dual -mode LCD screen with SunVue display "A variety of customized service options are available. The latest Lithium -ton battery technology and dual battery system allows for nearly six hour run time, automatic switching between external power and batteries, and an approximate two-year replacement cycle. Easy one -touch Bluetooth* data transmission. NONNI ?-lead EGG transmissions via -- iL F 1� the LiFENET System and ST segment trend monitoring make the LiFEPAK fb device a vital part of decreasing Y EMS -to -Balloon (E28) response times. Integrated Carbon Monoxide and Methemoglobn monitoring. t °fitiMtlltk owl I IF PRINT rI, �IIIII�IIIIIIIIIII�������((((((((((flJrrir�rrrrrrr�ra�,,,.,, Ergonomically designed handle has built-in shock absorbers for cushion and fits two gloved hands for easy pass off. CPR 11 W.YZE POP FACER RATE 1014S ENT ..... ..... PAUSE IAA CPR Metronome, a proven technology that actively guides users to, a consistent compression rate without the need for extra external hardware. Integrated Oridion EtCO, provides waveform ranges as low as 0-20 mmHg to help identify R,OSC or gauge CPR quality, consistent with the AHA, guidelines. The LIFEPAI monitor/ ME/ defibwrillater at a glance. ble connector onfidence for delivery, EM For six decades, Physio-Control has been developing technologies and designing devices that are legendary among first response professionals, clinical care 0=0 0 0 W07 Since we were founded in 1955„ Physio-Control has been giving medical professionals around the world legendary quality and constant innovation. Our LIFEPAK devices have been carried to the top of Mount Everest. They've been launched into orbit on the lnternational Space Station, And you'll find more than half a million units in use today on fire rescue rigs, ambulances, and hospital crash carts worldwide, We are inspired and informed by the rescuers who choose our products to save lives. The knowledge gained from working with some of the world's largest EMS organizations helps us constantly improve clinical standards and durability. Today, we continue our legacy of innovation with leading technologies that improve patient care. Our 360J b1phasic technology gives patients the best chance at survival. Our secure, web -based flow of ECG data helps improve STEMI patient outcomes. And our carbon monoxide monitoring helps catch the number one cause of poisoning deaths. From the streets to the emergency room to the administrative office, we offer a powerful suite of solutions that range from code response to quality control analysis. And even as we bring ground- breaking products to the market, some things don't change. As always, when you choose our products, you don't just get a device. You also get the most comprehensive warranty in the business, industry -leading technical service, and a partner with six decades of experience in emergency care. For more information about the UFEPAK 15 rnolWofl defibrillator -.-and how it can help you do what you do best --please contact your local Physio-Control reprpsent,�..itive or visit wwwphysio -con troL com, !"3AK''151VIO NITOR / DEF I B R I LLATOR LIFE Defibrillators/Monitors q LiFEPAK (,KPh.m Autotnatffll IExternar IDefifirfflator (AED) Featuring the same advanced technology trusted by emergency medjicW professionals —yet simple to use —the fulty automatic LIFEPAK CR Plus AED is designed specifically for the first person to respond to a victim of sudden cardiac arrest (SCA), JFEPAK"' 1000 DefibrMator The LIFEPAK 1000 Defibrillator is a powerful and compact device designed! to treat cardiac arrest patients and provide continuous cardiac monitoring capabilities, Built-in flexibility allows the 1000 to be programmed for use by first responders or professionals and enables care providers to change protocols as standards of care evolve, 11',EPAK' 15 Moinitor/Defibriflator The LIFEPAK 15 monitor/defibriilator is the standard in emergency care for ALS teams who want the most clinically innovafive, operationally effective and LIFEPAK TOUGHTm device available today. The 15 offers sophisticated clinical technologies with a rich array of features —like the most powerful escalating energy available (up to 360J), advanced monitoring parameters and a cornpietely upgraclable platform. LTEPAK'20o, Defibrfflator/Monitor mh'M CodeManagement ModLde Clinically advanced and packed with power, the LIFEPAK 20e defibrillator/monitor is highly intuitive for first responders, and also skillfully combines AED function with manual capability so that ACLS- '4 — trained clinicians can quickly and easily deliver advanced therapeutic care, The CodeManagement Module adds waveform capnography and wireless connectivity to enhance your hospital's ability to effectively manage resuscitations from preparedness through review, CPR Assistance LLJCAS` 2 Chest Compression Systern Designed to provide effective, consistent and uninterrupted compressions according to AHA Guidelines, LUCAS can be used on adult patients in out -of -hospital and hospital settings. `rr u e C P il Coachh'ig Duke TrueCPR helps your team optimize their manual CPR performance using simple real-time and post - event feedback on the most critical resuscitation parameters. It accuratety measures compression rN depth through proprietary Triaxial Field induction technology, Data Solutions Support LiFENET' Systeiin The LIFENET System provides EMS and hospital care teams with reliable, quick access to clinical information through a secure, web -based platform, helping to improve patient care, flow and operational efficiency. .............. . CODE-grAT" Data Review Software CODE-STAT data review software is a retrospective analysis tool that provides easy access to data, reports and post -event review. HeWtNEIVIS" HealthEMS is a remote -hosted field data collection, management and reporting software solution which is proven to help Fire and EMS providers improve patient care and financial performance. HealthFMS creates a two-way information flow which dramaticallY improves the accuracy and timeliness of information needed to support billing and clinical decision -making. PulsePoint PulsePoint Respond alerts CPR -trained bystanders about nearby sudden cardiac arrests in a public area. The app guides the responder to the public location of the incident using a map while also identifying nearby AEDs. Because the PulsePoint solution is integrated into the local dispatch center, alerts are only sent after 911 has been notified. PulsePoint AED is an app designed to build a comprehensive registry of AEDs available for use during cardiac emergencies. AED submissions are verified by the local agency and then become available within the Respond app. Physio-Control Service With a service plan from Physlo-Control, you are free to focus on your mission while relying on us to help to ensure the integrity of your fifesaving tools. From emergency repairs to software updates to, preventive maintenance, we respond to every service call with speed and expertise so you have the peace of mind to do your job with confidence. SPI C11=1GATIONS The LIFEPAK 15 monitor/defibrillator has six main operating modes: AED Mode: for automated ECG ana$ysis and a prompted treatment protocol for patients in cardiac arrest. Manual Mode: for performing manual defibrillation, synchronized cardioversion, noninvasive pacing, and ECG and vital sign monitoring. Archive Mode: for accessing stored patient information. Setup Mode: for changing default settings of the operating functions. Service Mode: for authorized personnel to perform diagnostic tests and calibrations. Demo Mode: for simulated waveforms and trend graphs for demonstration purposes. Weight: Basic monitor/dolibrillalor with now roll paper and two batteries installed: 7.9 kg (17,5 lot Fully featured monitorldefibrillator with new roll paper and two batteries installed: 8.4 kg (18.5lb) Lithium -Ion battery: sO.Bkg (1.31'b) Accessary Bags and Shoulder Strap:1.77 kg (3.9 lb) Standard (hard) Paddles: 0,95 kg 12.1 lb) Height: 31.7 cm (12.5 in) Width: 40.1 cm (15.8 in) Depth: 23.1 cm (9.1 in) Size (active viewing area): 212 mm (8.4 in) diagonal; 171 mm (6.7 in) wide x 1128 mm (5.0 in) high Resolution: display type 640 dot x 480 dot color backlit LCD User Seiectable Display Mode; full color or SunVueTn" display high contrast Display: a minimum of 5 seconds of ECG and alphanumerics for values, device instructions, or prompts Display: up to three waveforms Waveform Display Sweep Speed: 25 mm/sec for ECG, SpO,, IP, and 12.5 rem/sco for CO, [IM11MIZE, MINUMINEEM The device captures and stores patient data, events (including waveforms and annotations), and continuous waveform and patient impedance records in internal memory. The user can select and print reports, and transfer the stored information via supported communication methods. Report Types; - Three format types of CODE SUMMARYTr^ critical event record: short, medium, and long - 12-lead ECG with STEMI'statements Continuous Waveform (transfer only) -- Trond Summary - Vital Sign Summary - Snapshot Memory Capacity: Total capacity is 360 minutes 0f continuous ECG, 90 minutes of continuous data from all channels, or 400 single waveform events.. Maximum memory capacity for a single patient includes up to 200 single waveform reports and 90 rninules 0f continuous ECG. The device is capable of transferring data records by wired or wireless connection. This device compiles with Part 15 of the FCC rules„ and its operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Serial Port RS232 communication + 12V available Limited to devices drawing maximum 0.5 A current Bruotooth° technology provides short-range wireless communication with other Bfuetooth-enabled devices EGG ECG is monitored via several cable arrangements: A 3-wire cable is used for 3-lead ECG monitoring. A 5-wire cable is used for 7-lead ECG monitoring. A 1 O-wire cable is used for 12-lead ECG acquisition. When the chest electrodes are removed, the 110-wire cable functions as a 4-wire cable. Standard paddles or QUIK-COMBO pacing/defibrillation/ECG electrodes are used for paddles lead monitoring. Frequency Response: Monitor: 0.5 to 40 Hz or 1 to 30 Hz Paddles: 2.5 to 30 Hz 12-lead ECG diagnostic: 0.05 to 150 Hz Lead Selection: Leads I, II, III, (3-wire ECG cable) Leads I, II, Ili, AVR, AVL, and AVE acquired simultaneously (4-wire ECG cable) Lead's 1, II, Ill, AVR, AVL, AVF„ and C lead acquired simultaneously (5-wire EGG cable) Leads 1, II, III, AVR, AVL, AVF, V1,V2,V3,V4,V5, and V6 acquired simultaneously it0-wireECG cable) ECG size: 4, 3, 2.5,, 2,1.5,1, 0.5, 0.25 cm/mV (fixed at ii cm1mV for 12-lead) Heart Rate Display: 20-300 bpm digital display Accuracy: ±4% or ±3 bpm, whichever is greater QRS Detection Hangs Duration: 40 to 120 msec Amplitude: 0.5 to 5.0 m Common Made Rejection (CMRR)a ECG Leads: 90 dB at 50160'Hz. spol'1SPGOPSIIism t Sensors MASIMO sensors including RAINBOW" sensors NELLCOR" sensors when used with the MASIMO REDTM MNC adapter SII1102 Displayed Saturation Range: "<50" for levels below 50%;50to100% Saturation Accuracy: 70-100%(0-69%uunspecified) Adults/Pediatrics: ±2 digits (during no motion conditions) ,3 digits (during motion conditions) Dynamic signal strength bar graph Pulse tone as Sp02 pulsations are detected SpO Update Averaging Rate User selectable: 4, 8,12 or 16 seconds Sp02 Sensitivity User selectable: Normal, High SpOZ Measurement: Functional Sp02 values are displayed and stored Pulse Rate Range:25 to 240 bpm Pulse Rate Accuracy (Adults/Pediatrics): ±3 digits (during no:noUon conditions) ±5 digits (during motion conditions) Optional Sp02 waveform display with autogain control tiptAi ' SpCO Concentration Display Range: 0 to 40% SpCO Accuracy; ±3 digits SPME;f°" SpMet Saturation Range:0 to 15.0% SpMet Display Resolution:0.1%a up to 10% SpMet Accuracy: ±1 digit MBP Blood Pressure Systolic Pressure Rangm 30 to 255 mmHg Diastolic Pressure Range:16 to 220 mmHg Mean Arterial Pressure Range: 20 to 235 mmHg Units: mmHg Blood Pressure Accuracy: ±5 mmHg Blood Pressure Measurement Time: 20 seconds, typical (excluding cuff inflation time) Pulse Rate Range: 30 to 240 pulses per minute Poise Rate Accuracy: ±2 pulses per minute or t2%, whichever is greater Operation Features Initial Cuff Pressure: User selectable, 80 to 180 mmHg Automatic Measurement Time Interval: User selectable, from 2 min to 60 min Automatic Cuff Deflation Excessive Pressure: If cuff pressure exceeds 290 mmHg Excessive Time: If measurement time exceeds 120 seconds co, CO2 Range: 0 to 99 mmHg (0 to 13.2 kPa) Units: mmHg,, %, or kPa Respiration Rate Accuracy: 0 to 70 bpm: ±-4 bpm 71to99bpm: ±2bpm Respiration Rate Range: 0 to 99 breaths/minute Rise Time;190 msec Response Time: 3.3 seconds (Includes delay time and rise time) Initialization Time: 30 seconds (typical), 10-180 seconds Ambient Pressure: automatically compensated internally Optional Display: CO2 pressure waveform Scale factors: Autoscale, 0-20 mmHg (0-4 Vo$%a), 0-50 mmHg (0-7 V016/6), 0-100 mmHg! (0-14 Vol%o) invuashm, Piie,ssuure Transducer Type: Strain -gauge resistive bridge Transducer Sensitivity: 5pV/VlmmHg Excitation Voltage: 5 Vdc Connector: Efectro Shield: CXS 3102A 14S-6S Bandwidth: Digital tittered, DC to 30 Hz Lc -3db) Zero Drift: 1 mmHg/hrwithout transducer drift Zero Adjustment: -+150 mmHg including transducer offset Numeric Accuracy: ±1 mmHg or 2% of reading, whichever Is greater, plus transducer error Pressure Range: -30 to 300 mmHg, in six user selectable ranges h'avasive Pressure Display Display: IP waveform and numerics Units: mmHg Labels: P'1 or P2, ART, PA, CVP, ICP, LAP (user selectable) "Temperature Range: 24.8° t0 45.2°C (76.6° to 113.4'F) Resolution: 0.1"C Accuracy: ±0.2°C including sensor Reusable Temperature Cable: 5 foot or 10 foot Disposable Sensor Types; Surface -Skin; Esophageal/Rectal Time Scale: Auto, 30 minutes, 1, 2, 4, or 8 hours Duration: Up to 8 hours )ST Segment: After inifial 12-lead ECG analysis, automatically selects and trends LOG lead with the greatest ST displacement Display Choice of: HR. Pit (SP02)1 PH (NtBP), SP02 I%)' SiPCO N1 SPMet (0/')' CO2 (EtCO)F 'CO2) , HR (CO), NIBP, JP1, IP2, ST Quick SOL Activates alarms for all active vital signs VF/VT Alarm: Activates continuous (CPSS) mon!tGring in Manual mode Apnea Alarm: Occurs when 30 seconds has elapsed since fast detected respiration Heart Rate Alarm Limit Range: Upper, 100-250 bpm; lower, 30-150 bpm 12-Lead Interpretive Algorithm; University of Glasgow 12-Lead FOG Analysis Program, includes AMI and STEMI statements Prints continuous strip of the displayed patient information and reports Paper Size: 100 mm (3.9 On Print Speed: 25 mm/sec or 12.5 narri Optional; 50 mmlsec time base for 12-lead FOG reports Delay: 8 seconds ­,Auloprint: Waveform events print automatically rirequency Response: Diagnostic: 0.05 to 150 Hz or 0.05 to 40 Hz Monitor: 0.67 to 40 Hz or 1 to 30 Hz Blithasic Waveform: Biphask; Truncated Exponential The loillowing specifications apply from 25 to 200 ohms, unless otherwise spieclflepl:� Energy Accuracy, t1 joule or 10% of setting, whichever is greater, into 50 ohms, t2 joules or 15% of setting, whichever is greater, into 25-175 ohms. Voltage Compensation: Active when disposable therapy electrodes are attached. Energy output within ±5% or ±1 joule, whichever is greater, of 50 ohms value, limited to the available energy which results in the delivery of 360 joules Into 50 ohms. Paddle Options; QUIK-COMBO pacing/defibrillation/ECG electrodes (standard). Cable Length 8 foot long (2.4 rm QLJIK-COMBO cable (not Including electrode assembly). Standard paddles (optional) Mantiall Mode Energy Select: 2, 3, 4,5,6, 7, 8.9,10, 15, 20, 30, 50, 70,100, 125, 150,175, 200, 225, 250, 275, 300,325, and 360 joules Charge Time: Charge time to 360 joules in less than 10 seconds, typical Synchronous Cardlovershani: Energy transfer begins within 60 msec of the QRS peak Paddles Leads OFF Sensing: When using QUIK-COMBO electrodes, the device indicates Paddles Leads OFF if the resistive part of the patient impedance is greater than 300 ±15% ohms, or if the magnitude of the patient )mnpeclance is greater than 4410 ±15% ohnis. Shook Advisory SySteraTIM (SAS); an ECG analysis system that advises the operator if the algorithm detects a shockable or non -shockable FOG rhythm. SAS acquires ECG via therapy electrodes only. Shock Ready Time: Using a fully charged battery at normal room temperature, the device is ready to shock within 20 seconds if the Initial rhythm finding is "SHOCK ADVISED" Biphasic Output: Energy Shock levels ranging from 150-360 joules with same or greater energy level for each successive shock cprMAX1m Technology. In AED mode, cprMAXTM technology provides a method of maximizing the CPR time that a patient receives, with the overall goal at Improving the rate of survival of patients treated with AEDs. Setup Options: - Auto Analyze: Allows for auto analysis. Options are OFF, AFTER 1 ST SHOCK - Initial CPR: Allows the loser to he prompted for CPR for a period of time prior to other activity. Options are OFF, ANALYZE FIRST, CPR FIRST - Initial CPR Time: Time interval for Initial CPR, Options are 15, 30, 45,60, 90,120, and 180 seconds. - Pre -Shock CPR:Allows the iuser to be prompted for CPU while the device Is charging. Options are OFF, 15,30 seconds. - Pulse Check: Allows the user to be prompted for a pulse check at various times. Options are ALWAYS,AFTER EVERY SECOND NSA, AFTER EVERY NSA, NEVER - Stacked Shocks:Allows for CPR after 3 consecutive shocks or after a single shock. Options are OFF, ON - CPR Time: 1 air 2 User selectable times for CPR. Options are 15, 30,45, 60, 90,120,180 seconds and 30 minutes. Pacing, Made: Demand omen -demand rate and current defaults Pacing Rate:' 40 to 170 PPM Rate Accuracy. ±1 .5% over entire range Output Waveform: Monophasic, truncated exponential current pulse (20 ± 1 ms) Output Current: 0 to 200 mA Pause: Pacing pulse frequency reduced by a factor of 4 when activated Refractory Pini 180 to 280 msec (function of rate) Unit masts functional requirements during exposure to the following environments unless otherwise stated, Operating Temperature: 0' to 45°C (321 to 113'F); -20°C (-4'F) for 1 Incur after storage at room temperature; 60°C (1401F) for 1 hour after storage at room temperature Storage Temperature: -20* to 65°C (-4' to 149°F) except therapy electrodes and batteries Relative Humidity, Oparatlflig: 5 to 95%, rem -condensing. li 15 to 95%, non -condensing Relative Humidity, Stara 10 to 95%, non -condensing Atmospheric Pressure, Operating: -382 to 4,572 in (-1,253 to 15,000 It), NIOP: -152 to 3,048 in (-500 to 10,000 It) Water Resistance, Operating. IP44 (dust and splash resistance) per IEC 529 and EN 1789 (without accessories except for 12-lead ECG cable, hard paddles, and battery pack) Vibrallom MIL-STO-8101E Method 514.4, Propeller Aircraft - category 4 (figure 514.4-7 spectrum a), Helicopter - category 6 (3.75 Grins), Ground Mobile - category 8 (3.14 Gnarls), EN 1789: Striusoldal Sweep, 1 octave/min, 10-150 Hz, t0.15 min/2 g Shock (drop): 5 drops on each side from 18 inches onto a steel surface EN 1789: 30-Inchi drop onto each at 6 surfaces Shock (functional): Meets IEC 60068-2-27 and MIL-STD- 81 OF attack requirements 3 shocks per face at 40 g, 6 ms half -sine pulses Bump: 1000 bumps at 15 g with pulse duration of 6 msec Impact, Non -operating: EN 60601-10,5 + 0,05 joule impact UL 60601-16.78 Non impact with 2-Inch diameter steel ball. Meets IEC62262 protection level IK 04. EMC: EN 60601-1-2:2006 Medical Equipment -General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests EN 60601-2-4:2003: (Clause 36) Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator- Monitors Cleaning: Cleaning 20 times with the following: Quaternary ammonium, isopropyl alcohol, hydrogen peroxide Chemical Resistance: 60 hour exposure to specified chemicals: Bletadine (10% Povidarm-Iodine solution), Coffee, Cola, Dextrose (5% Glucose Solution), Electrode Gel/ Paste (98% water, 2% Carbopol 940), HCL (0.5% solution, pH=1), Isopropyl Alcohol, NaCI solution (0.9% solution), Cosmetic discoloration of the paddle well shorting bar shall be allowed following exposure to HCL (0.5% solution). ISM30MENNOMMOSOME Power Adapter% AC or DO Power Adapters provide operation and battery charging from external AG or DO power - Full functionality with air without batteries when connected to external AC/D,C - Typical battery charge time while installed In LIFEPAK 15 device is 190 minutes - indicators: external power indicator, battery charging indicator Dual battery: Capability with automatic switching Lawbattery indication and message: Law battery fuel gauge indication and low battery message in status areafor each battery Replace battery Indication and message: Replace battery fuel gauge indication, audio tones and replace battery message In the status area for each battery. When replace battery is indicated, device auto -switches to second battery. When both batteries reach replace battery condition, a voice prompt instructs user to replace battery. Battery Capacity For Won, now fully-cltarged batteries, 20'C (681) Operating Mode Monitoring Pacing Defibrillatlen (manures) (minutes) (3130,1discharges) Total Capacity Typical 360 340 420 to Shutdown ml,, in . an 340 320 400 Capacity After Typical 21 20 30 Low Battery Ml,,,,, 12 10 6 Battery Specifications Battery Type: Lithium -Ion Weight: 0.6kig (1.31b) Charge Time (with fully depleted baltery): 4 hours and 15 minutes (typical) Battery Indicators: Each battery has a fuel gauge that indicates its approximate charge. A fuel gauge that shows two or fewer LEDs after a charge cycle indicates that the battery should be replaced. Charging Temperature Range: 5' to 45°C (41 ` to 11 3'F) Operating Temperature Range: 0' to 4 51C (32' to 113°F) Short Term (41 week) Storage Temperature Range: -201 to 601G (-41 to 1401F) Long Term (>1 week) Storage Temperature Range: 201 to 25°C (68* to 777) Operating and Storage Humidity Range;! 5 to 95% relative humidity, non- condensing Genuine Accessories from Physio-Control LEFEflAK-15MON ITO R /DEHBR I LLATOR kit", 011 I Thank you for, choosing Physio-Control as your partner in helping save lives and improve patient care. You already know our reputation for quality and reliability in LIFEPAK defibrillators and AEDs, When it comes to LIFEPAK accessories, we know you won't accept anything less. Inside this catalog you'll find accessories designed to meet your needs and reliability standards., All the accessories and disposables in this catalog are designed to work with the LIFEPAK 15 monitor/defibrMator. If you have any questions about accessories or disposables, please contact your Physio-Control representative. L.1FEPAK'15MON ITO R /D EFIBR I I-LATOR 6 Fl Temperature Adapter Cable 11140�-000079 (10fl) 11140-000078 (5fI) NIBP Tubing 21300-007299 (NI) 21300-007298 (12R) is= I Esopliageal-Rectal Temperature Sensor 11996-000360 (9FR, 20/box) SkinTeniperatLIM Sensor 11996-000359 (20/box) Foley GathetorTemperature Sensor 11996-000361 (14FR, 10/PK) 11996-000362 (1618, 1 Qlpkp 11996-000363 (1 8R, 4Glpk) Reusable Cuff Single Patient Use Cuff X-Largo Adult Pediatric X-Large Adult Pediatric 35 x 44 cm 13 - 20 crin 35 x 44 cm 13 20 C.111 11160-000009 11160-000003 11160-000010 11160-000004 1',..ai,ge Adult Infant Large Adult Infant 32 - 42 cm 8 - 14 cm 32 - 42 cm 8 - 14 cin 11160-000007 11160-0000011 11160-000008 11160-000002 Adult Adult 26 - 35 cm 111160-000005 26 - 35 cin 11160-000006 NIBP Tubing, Coiled 21300-007300 (291t) AC Power Adapter lncludos Right Angle Cable (AG power cord not included) 11140-000072 DC Power Adapter lncludes DC cable and Right Angle Cable 11140-000074 REDI-CHARGE Base AC power cord and adapter tray not illdUded. 11141-000,116 REDI-CHARGE LlFEPAK 15 Adapter Tray 11140-000052 AG Power Cord 11140-000015 Mobile Battery Charger Includes AG and Kpovvei cords, mounting bracket rand operafliig i(IMRIGUTIS. 11577-000011 AG Power Cord 11140-000015 Power Attachment Kit 11577-000019 Lithiuni-Ion Battery 5.7 Ah 5.7 amp hour, l L I volt, recharpable, MVi fuel tJaLl(je, 21330-001176 Extension Cable for AC/DC Power Adapter 111140-000080 Replacement Right Angle Power Cable for AC/DC Power Adapter 11140-000081 Replacement DC Input Cable 11140-000084 LIFE PAI("15MO NITOR / DEFI B R I FLA FOR ECG Monitoring Accessories 12-Lead EGG Cable Trunk Cable with 4,.Wir(, 1-finl) Leads 11111-000018 (511) Ili 11-000020 (8f I) "12-1-ead ECG Cable 6-Wire Precordial Attachrnent 11111.000022 3-Wiro EGG Cable 5-Wire ECG Cable Higlil-am'llp, connector Ought -angle conneclai, 4-wire Uimb plus rune 11110-000029 chf,sl lead, Wwled N I" on We [AFEPAK 15 momitor lej)00s 11110-000066 EGG Electrodes Adult, piegelled. 11100-000001 (3/pi�) LIFE-pivrelI EGG Electrodes Adult, p�egelled. 11100-000002 (4/j*) 4-wire Cable Comb 21300-008054 (10/pk) 6-wire Cable Comb 21330-0080�55 (10/1%) Box of Strip Chart Recorder Paper 100nm x 22m 11240-000016 12 rolls/box) UMMEMNAIRSOMMOMm Har-d Paddles and Electrode Gel All Standard Hard Paddles Pediatric Paddle, External SIGNAGEL" Electrode Gal 11130-000,061 (1 pair) (Two ieq(Ared): slips onto sland,'jjrj adult hard For use with hard paMes. Highly conductive, wulfi- paddle, purpose electrolyte meets all the standards of the 11133-00�0007 (1 PaMie) ideal saline electrode gel. Recommended for ECG, deffirillafim, Nofeedback and EMG. 21300-005847 (8.5 oz/tube) Internal Paddles (RBqLfires Internal Paddle Handles and Internal Paddles Adapter Cable) 1 in, size 11131-000010 (1 Plif, 625io. shatt) 1.5 in, size 11131 -000011 (1 pair, 6 fir. shalt) 11131-0000211: (1 pa4, 0 in shaft) 11131-000024 (1 pair, 14 in. shaft) 2 in, size 11131-000012 (1 pair, 5 75 in shaft) 11131-000022 (11 pair, 8.75 in. shaft) *"11111111114W 2.5 in, size 11131-000013 (1 pah, 5.5 in. shaft) 11131-000019 (1 pair, 8.5 in Oaftl 3.5 in, size 11131-000014 0 pair, 5 in. shaft) 11131-000023 (1 jmVi, 8 in. shal tl) Internal Paddle Handles with Discharge Control (For use with the Iniernal Paddles Adapter Cable) 11131-000001 (1 pa4) Internal Paddles Adapter Cable (For use with Irilpmal PaWle Handles) 11998-000326 LIFEPAK'15MON I TOR / DEF I BR I LLAFOR EDGE 'Systeffl"` Ellectriodes for �3a(,,,��ig/Def�br���al�-,�on/ECG vvfthl QIYK-COMBO"" Connector 18-111011th milillnum Aellf We remaining ,,It l of shipillent flour Pllysio-C.ontrol excell where, noled, EDGE System Electrodes with QUIZ{ -COMBO Connector 24 ljl. fekvilre length 11996-000091 Pediatric EDGE System RTS Electrodes with QUIK-COMBO Connector l'or use, only with niallul lillullitor/Clefiblikitols� 12 il minimum shelf Me M time of shipment 211 in, letadwire length. 11996-000093 EDGE System RTS (Rachil if spare fit) Electrodes with CIUM-COMBO Connector 24 ri. 1l11,'1dvjlre1 longth 11996-000090 QUIZ(-COMBO'nierapy l Willi cenvenient TRUE-LOCKTINI Cable Connector. Lengthy is apinxinWely 8 It. For use with LIFEW 15 moniloridell 111113-000004 EDGE Systern Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System 42 ln. lendwire length 11996-000017 Mash,no SET" RC Patien't Cables RC Patient Cable For use AM M-LNCS and Rainbow Patienl Sensors 11171-000037 )C) 11171-000038 Mlft) Masho SET RC, Patient Cable Compatible SpO, Sensors 1 Gomm 34l oil OWN011 nr M-LNCS Reusable Sensor M-LNCS, Adhesive Sensors (20/box) M-LNCS Adhesive Sensors (20/box) 11171 -000046 (Ad' 11171-00003'9 (Adp 11171.0000,43 (Nea/P[) 11171-000047 (Pad) 11171-000040 ftd) 11171-000042 (Neo*l) 11171-000041 (hf) Masirno SET R,C Nifient Cable Cornpafib,Ie Mnbow"' SP02, SPCO', SpMet Sensors Rainbow Reusable Sensor 11171-000049 (Ad) 11171 -000050 (PO Rainbow Adhesive Sensor (10/box) 11996-000342 jhl� 119l96-000341 (Nen/Ad) Rainbow Adhesive Sensor (1(t/box) 1199�6-000339 (Ads� 1199l6-000340 (Ped� L I F IIE �PA KI 5M ON I I OR / DEF I B R I LLATOR ii��i III `111� 11111 Ir iiil Masirno SET' LNC Pabent Cables Red LNC Patient Cable For LISL with LKS Fatient Sensois 1 1996-000�323 (41t) 11996-000324 (Mfl) 11996-000325 (141) Mash,io SETLAC Patlent Cable CompatiNe SP02 S01"ISOt'S LNCS Reusable Sensor 111171-000017 (Ad) 11171-000018 (Pod) ME LNCS Adhesive Sonsol'(20/box) 11171-000019 @Ad) 11171-000020 (Pee) rRm LNGS Reusable Soft Sensor 11171-000052 (Ad) ME LNGS Adhesive Sensor (20/box) 11171-000029 (Neo/Pt) 11171-000028 (Neo/Akl) 11171-000031 gIjnl) Pul�lse, Oximetry Monitoring Accessories, LIFErIAK 15 Dlirect Connect SpO, Only 1"atient Sensors Adult Reusable Direct Connect Sensor Pediatric ReusabIle Direct Connect Sensor AcILM Reusable Soft Direct Connect Sensor 111996-000331 (M) 11996-000,333 (aft) 11171-000053 (Wt) 111996-000332 (12Q) 11996-000,334 (12ft) I-WEPAK 15 Drect Connect Rainbow SP02, SPCO,l SpMet IF atient Sensors Adult Rainbow Direct Connect Reusable Sensor 11996-000335 (A) 11171-000032 (8ft) 11996.000336 (1211) Addiflorial Masirno Access,ors Pediatric Rainbow Direct Connect Reusable Sensor 11996-00,0337 (3ft) 11171-000033 (8ft) 11996-000338 (12fO Red ZINC Cable Connects LIFEPAK 15 to Nellcor patient sensor 11996 - 000365 (4f 1) 11996-000366 (IWQ Reusable Ambient Disposable Ambient Light Shield Light Shield 11171-000054 (5/baj11171-000,055 (10/bafj) LIFIEPAK 15MON I TOR/ DEF1 BR I LLAFOR q 1111111 11111q� ill : iiiq��iiip Nekor Reto,,INe Sensor's md Catfles WI 1001,11--1, DURASENSOR Reusable Clip 11996-000060(Adult RPIPDS100A) DlJHA-Y Multisite Reusable Sensor 11996-000106 (.-, 0 q - Refit 11 Y,,) Nekcar Disposade Senscirs 0 "WWO -1 I)',1IiPnt He -4f, 0xisensor 11 (2,miox) Aduk 11996-000113 (Vin. � RoP 025) 11996.000114 (36 in. - RePID25L) Pedialric 11996-000116 (18 in,- ReW D20) oxisensor 11 (Atox) hnant 11996-000115 (18 in. - N0 20) Neonatal/Adult 11996-000117 (18 in. - Reffft N25) 0xiband Reusable Sensor k1cludes 50 Jiposable adhesive sensom 11996-000061 (Ad/New Ro.141 OXI NN) 11996-000062 (Ped/lnt � H0#0XI I'd) Disposable Adhesive Bandage Wrap No, t AvaiIahle, nn Cinada� (I 00/pk) 11996-000048(Ad/Neo HeWADHA/N) 11996-000049 (Ped/14 - Refit ADH P/1) Disposable Adhesive Foam Wrap Not Available in Canada. (1: Wplo 11996-000110 (Ad/Neu - H'e,10 fOW A01) 11996-000108 (Ped/Int - HeIg FOAM P/1) Oridioln" Filterhes for Intubated Patients Single patient use FilterLine' SET Key Applications: OR, EMS, F. D, Rapid Response leans, rransport, Adult/Pediatric 119916-000,081 (25/pk, 200 cm) 11996-000164 (251pk,400 cm) Ordon Nm]ntubated Fiftedines Single patient Use Smart CapnoLine" Plus Key Applications: Procedural Sedation, Upper GI Procedures, MAC, RIMS, RD. Rapid Response "leanns AdUR With 0, 11996-000163 (25/pk, 200 cm) 11996-000167 (100/1)k, 200 cm) 11996-000165 (25/pk, QO cnO Adult WMIOUt G„ 111996-0001,62 (25/pk, POO CIT) 11996-000166 (1001[)k, 200 cil1) FilterLine H SET Key Applications: Gritcal care, Huindfied Environments. Adult/Pediitric 11996-000080 (25/pk, 200 cmi Adull/NeomU 11996.000001 (251plk, 200 cm) Smart CapnoLlne Key Appkations: Procedmal Sedation, SMS, SD, Rapid Response learns, Pediatric with O, 111996-000128 (25/pkl 200 cm) Pediatric without 0, 11996-00012�0 (25/pk, 200 cm) LIFE PAK'15M ON ITOR / DU I B R I LLATOR Standard Carrying Case ndtjdes right pouch and left pouch, for arse vAth LIFFPAK 15 monirorAleHbOlWor 11577-000002 Top Pouch Shoulder Strap For use with LfFFPAK 15 moniior/defibidlaWi 11577-000001 [lack Pouch Sloiage for sensors an eledwdes; hisei t ill rAnce deal tor iddtiot4 iccessorystoiage. of slalrdald JmOdlps, For use with UIFEFAK 15 monRoi/defibMIator. 11220-000028 11260-000039 COMMUlk].EifirI ccessories LIFFPAK Monitor to PC Cable For conneding LIFFPAK 12 or LIFFFIAK 1y monitoi/delibriflator to PC 11230.000020 (Serial) 11996-000369 (e-W) ritarr ii wireless Gateway For transmitfing data from LIFUIAK 12/15 Io (he 1, IFENET System or CODE-SIAI data revre� v solkv,'vr; He quire's existing vviieless relwork 21996-0000�73 INireiass Gateway) 21996-000093 6Vireless 3G Ga4evjay AW, Wdzw, vwlzon/physiu) 21996-000094 (Wjfrldess K t Voice GMeway I AIN/111hysin) 21996-000092 (Wireless W, + Voice Gareway - AT,%,T, velizoll, vmizojldlllysio)} Bed Connector For use in 110SPilal 0111Y. 11996-000374 of, 'OF 3G Gateway For Iransmittling data li,om I IFEPAK 12/13 to the [IFENET System or COOF SJAJ daLi [evlew soQvjaro. Rotgiries data plan. 21996,-000086 pVmlzun Gatemy) 99428-000305 (Vei!zcr Data Plan) 21996-000082 (AI&T C„kvmy) 99428-000304 IAl,�I Oah Man) N. r Defibrillator Checker Tests integrity of energy delivery through standard barel Paddles. Neon fight indicates energy has been delivered. 119198-000060 Inservice Viideo: LIFEPAK 15 Monitor/Defibrillator 21330-001357 (UVO - NTSC version) Operating Instructions: LIFEPAK 15 Mon itor/Delibriliator Also available as free online download at mmPhysio-conlrol.com 26500-002408 12-Leact Patient Sinnulatnr (QUIK-COMBO) Connects directly to your LIFEPAK defibrillator for .safe simulation of cardioversien and electrical capture, Generates fibrillation, tachycardias, and bradycaedias, as well as ST segment and T awave abnormalities, For use with LIFEPAK devices with a 12-lead ECG feature. 11996-000311 3-Lead Patient Simulator (QUIKµCQMBQ) Connects directly to your LIFEPAK defibrillator for safe, Interactive traiNng. Select from '17 ECG rhrythrns Including: fibrillation, tachycardias and bradycardias. 11996-000310 �r�rrM Test Load Use to perform therapy cable Performance checks, Connects to the CUIK-COMBO therapy cable on the defibrillator, 21330-0011365 (English only) 21330-001367 (English, French for Canada) UNIVERSITY Ptlysio-Control University 12-Leads Made Easy 44500-000001 Capno Made Easy 44500-000003 Respond with confidence; Rely on service from Physio-Control ryrker MR OUr service plans, go beyond keeping your devices rUnning at peak performance. Your service representative will get to know you and your team, answer questions specific to your devices, give reminders about proper device operation, and advise you about new features and accessories to help you maximize efficiency. Onsite service If you ever need us, your dedicated service representative comes to your location with just one phone call. Backup support from our team is always available. Expertise Your service representative is 100% focused on Physio-Control devices. With an average of 14 years' experience, nobody knows your devices better. Because they carry a large inventory of spare parts, representatives can often repair your device onsite. Customer satisfaction Our service representatives consistently receive the highest marks in customer satisfaction —an average satisfaction rating of 6.8 out of 7 in our onsite service survey. Because they are part of your community, they are completely dedicated to helping you achieve your goals. -i lets yoi-i foct,.ir-') ori A service plar yux' i nission. Confidence in the readiness of your device. E Comprehensive maintenance and inspections can hdp find issues before they cause problems I'm Most repairs performed within 48 hours, if not sooner Control costs. 11 Minimize unexpected costs and make budgeting more predictable III Stretch your budget further with additional discounts Less hassle, fewer disruptions. FA Inspection schedules that put minimal demand on your staff and equipment in Your rep tracks maintenance and device status, and provides documentation for your compliance needs IN Onsite Service option eliminates hassle of boxing up devices and shipping them out when a repair is needed IN No need to get a purchase order or obtain approvals Choose the b�est service plan for your needs Preventative Repair Plus Comprehensive . . . ...... . Maintenance Preventive maintenance and V/ V/ inspection service Configured loaner device during VI/ V/ preventive maintenance or repairs . . .. .. . ......... ... . . . ------ Discounts on upgrades, accessories V/ ✓ V/ and disposables ..... . .. ....... . Software updates, V/ V/ . . . 24/7 telephone support . . . . .... . .......... ....... .. . . .. - _ ..... . ...... ............... V/ V V/ (Battery-replacement service V/ ---- - ----- . .......... . Parts and labor for repairs . .. ....... .... ........ . . . ..... Discount . ..... - - ------ V/ To find out more about our Service Plans, please contact a Sales or Service Representative at 800-442-1142. We're rlgh�t I'ier-&­-rigit, when you need �_is. Every day, you protect the people in Your community during all types of events —from festivals to football games, or even when disaster strikes. With local representatives across the country, Physio-Control is able to respond when our customers need us most. Specific services affered by device. LlFEPAK@ 15/12 monitor/defibrillator LIFEPAK 1000 defibrillator/ LIFEPAK CRII Plus AED Update software to the most current version Check all batteries and battery pins Inspect the integrity of accessories and recommend replacement as needed Test the integrity of all cables and recommend replacement as needed Electrical safety check in accordance wrth NFPA guidelines Computer -aided diagnostics to test 30 device dimensions and verify the unit functions accurately, from waveform shape and clefibrillatilon energy to pacing current and capnography readings (if present) Check electrode expiration dates and recommend replacement as needed Check printer operation and trace quality Test the integrity of all cables and recommend replacement as needed Electrical safety check in accordance with NFPA guidelines Computer -aided diagnostics to verify the unit functions accurately, including waveform shape (LIFEPAK 1000 defibrillator only) and defibrillation energy Replace up to one (1) battery pack in accordance with the device operating Instructions or upon battery failure (LIFEPAK 1000 defibrillator only) Replace one (1) set of expired adult therapy electrodes at scheduled time of service (LIFEPAK 1000 defibrillator only) Replace up to one (1) CHARGE-PAK Tm and two (2) WK-PAKIM electrodes at time of service (LIFEPAK OR Plus AED) Repairs (parts and labor) to restore equipment to manufacturer specifications ILIFEPAK battery -charger repair or replacement as deemed necessary by Physlo-Control Power -adapter repair or replacement Replace up to three (3) Iiithium-ion batteries in accordance with the device operating instructions or upon failure Replace two (2) NiOd or up to two (2) S,LA batteries (LIFEPAK 12 only) Replace up to one (1) coin cell memory battery in accordance with the device operating instructions or upon failure Combines benefits of Repair Plus and Preventive Maintenance Service Plans LUCAS" 2/3 chest compression system Test linear sensor and recalibrate if needed Lubricate and adjust mechanical parts, Including compression module and claw lock Clean hood, fan, intake and bellows Perform functional test on all mechanical components and electronics Computer -aided diagnostics Replacement of LUCAS Disposable suction cup, LUCAS Patient Straps, or LUCAS Stabilization Strap, as deemed necessary by Physlo-Control Replace up to two (2) LUCAS chest compression system batteries in accordance with the Instructions for Use or upon battery failure LUCAS Battery Desk -Top Charger, LUCAS Aux Power Supply, LUCAS Car Cable repair or replacement as deemed necessary by Physio-Control Replacement of LUCAS Disposable suction cup, LUCAS Patient Straps, or LUCAS Stabilization Strap Service Plans are also available for the LIFEPAKO 20e defibrillator/monitor; please contact your local Physio-Control Representative for more information. Service details. dnsite Services are performed between 8:00am and 5:00pm local time, Monday through Friday, excluding holidays. Customer is to ensure Covered Equipment is available for Service at scheduled times or additional labor charges may apply. Some Services may not be completed onsite, Physio-Controi will cover travel and/or round-trip freight for Covered Equipment that must be sent to our designated facility for repair. Ship -In Service will ship your device to the nearest service center for repairs and inspections. We use only original manufacturer parts, and services will be performed at a designated Physio-Controt facility. Physio-Control will cover round-trip shipping (ground only) for covered equipment sent to our designated facility for service. Loaners will be provided if Covered Equipment must be removed from use to complete repairs. Physic - Control will strive to provide Customer with a similar loaner device until the Covered Equipment is returned. Customer assumes complete responsibility for the loaner and shall return the loaner in the same condition as received, upon the earlier of the return of the removed Covered Equipment or Physio-Control's request. Updates are changes to a device to enhance its current features, stability or software. Physio-Controf will install Updates at no additional cost, provided such Updates are installed at the time of regularly scheduled Services. Updates at a time other than regularly scheduled Services will be billed on a separate invoice at 20% off the then -current list price of the Update. if parts must be replaced to accommodate installation of new software, such parts may be purchased at 30% off the then -current list price. Upgrades are major, standalone versions of software or the addition of features or capabilities to a device. For all Service Plans, Upgrades are not provided under the Plan and must be purchased separately. Upgrades are available at I r% off the them -current list price. Service Plans do not include: supply or repair of accessories or disposables; repair of damage caused by misuse, abuse, abnormal operating conditions, operator errors, acts of God, and use of batteries, electrodes or other products not distributed by Physio-Control; replacement or repair of cases; repair or replacement of items not originally distributed Or installed by Physio-Control; Upgrades and installation of Upgrades. Physio-Control is now part of Stryker, For further information, please contact Physio-Contral at 800.442.1142 or visit our website at www.physio-control.com Physio-Cmitrol Headquarters 11811 Willows Road NE Redmond, WA 98052 w W w. Physio-COntrQLCQM Customer Support R O. Sox 97006 Redmond, WA 98073 Toll free 800 442 1142 (,D2017 Physio-Conlrol, Ina Not all products and sarvices avallablo in all cnunlries_ GOR 332470D C