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
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Section 3
Product Information
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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
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Ergonomically designed handle
has built-in shock absorbers
for cushion and fits two gloved
hands for easy pass off.
CPR 11
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RATE
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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