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Home My WebLink About1999 04 26 Consent Item A , .. COMMISSION AGENDA ITEM A CONSENT X INFORMATIONAL PUBLIC HEARING REGULAR Meeting MGR ~EPT ":V j, Authorization { April 26, 1999 REQUEST: Fire Department requesting authorization for expenditures from the Medical Transport fund for Heart Monitor Defibrillators. PURPOSE: The purpose of this Commission item is to gain Commission authority for expenditures from the Medical Transport fund for four (4) Hewlett-Packard Corp. 12 Lead Heart Monitor Defibrillators from the sole source distributor Laerdal Medical Corporation for an amount not to exceed $48,815.00 which includes trading in existing equipment. CONSIDERATIONS: The Fire Department has been administering Advanced Life Support (ALS) procedures to patients since authorization by the City Commission with the Paramedic Program in 1981. Paramedics have utilized a portable heart monitor defibrillator to assist diagnosis of heart activity and to shock the heart when in a condition of fibrillation. The original heart monitor defibrillators that were purchased for the program are still in service today however technology has changed significantly since that time. The original heart monitors were capable ofthree lead monitoring and did not offer any predictive or analysis of heart activity. These devices relied entirely on the paramedic's diagnosis and provided limited information to the paramedic via a small display and printout of Electro Cardio Gram (ECG) activity. The Department has three (3) ofthese original three lead heart monitor defibrillators that were manufactured by Physio Control. In early 1990's the Department purchased three (3) Marquette 12 Lead Heart Monitor Defibrillators to replace the original units. These units provided a better monitor that also allowed the paramedic to pace the heart with this newer technology. The Marquette units April 26, 1999 Consent Agenda Item "A" Page 2 also recorded the event with the capability to review at a later time the interventions that the paramedic provided to the patient. The Department with the 1998/99 budget requested and was approved to purchase two units to replace two of the three Marquette units. We were also in the process of surplusing the original three Physio Control units that were purchased in early 1980's and had evaluated all current manufacturers of portable heart monitor defibrillators for purchase. The Department's overall plan was to replace two units this budget year and to replace two units next year, however it was determined during evaluation of current equipment that it was not Year 2000 Compliant so therefore we have proposed to replace all current equipment this fiscal year. The Hewlett-Packard equipment being proposed by Laerdal Medical Corporation is the equipment of choice by the Department Medical Director and by the Department Equipment Committee. These units are Y2K compliant and offer these sole source items such as the only DefibrillatorlMonitor to incorporate advanced predictive instruments, the easy use of QWERTY keyboard controls, and a complete 5-year warranty. Laerdal Medical Corporation has also offered to trade in our existing equipment to reduce the cost ofthis project. The total project would require us to trade in three Physio Control Lifepak 5's with charger and three Marquette Medical 1500SLP's. In return our purchase would include four Hewlett-Packard CM100 Monitor Defibrillators with battery systems. FUNDING: Funding for two units was requested and approved in this current year budget. However, I am requesting to amend the original appropriation from two units to the purchase of four Hewlett-Packard CMlOO Monitor Defibrillators with battery systems units for a total amount not to exceed $48,815.00 from the Medical Transport Fund Reserves. April 26, 1999 Consent Agenda Item "A" Page 3 RECOMMENDATION: It is recommended that the City Manager be authorized to purchase four Hewlett-Packard CM100 Monitor Defibrillators with battery systems including trading in existing equipment from Laerdal Medical Corporation for an amount not to exceed $48,815.00 from the Medical Transport Fund Reserves. IMPLEMENTATION SCHEDULE: Purchase, equipment delivery, and training within 30 days. ATTACHMENTS: 1. Quote from Laerdal Medical Corporation Sole Source Letter from Laerdal Medical Corporation Laerdal Medical Corporation notification on Year 2000 Compliance Product Information COMMISSION ACTION: ~ laerdar helping save lives Chief Timothy Lallathin Winter Springs Fire Rescue 102 N. Moss Rd Winter Springs FL 32708 We are pleased to quote as follows: Qty. 4 Catalog # LCM05 4 M2480B 4 4 M1940A M1191 3 3 Description CM 100 Monitor/Def W /12 Lead Complete. Includes: Adult/Pediatric Paddles, 12 & 3-Lead ECG Cable, Ten (10) Disposable ECG Electrodes, "Hands-free" Cable with Adaptor for Heartstart Electrodes, 2 rolls of Recorder Paper, User's Guide, Quick Reference Guide, Training Video Tape, Battery Support System. 2.5Amp-hour NiCad, Internal Modem Battery, Paramedic Carrying Case, and 2 pairs of Heartstart Electrodes. Load Tester Ischemia Analysis/Predictive Instruments. Reuseable Sp02 Trunk Cable Reuseable Sp02 Adult Transducer 5 Year Warranty TRADE-IN SUBJECT TO EQUIPMENT EXAMINATION Marquette Medical 1500SLP Lifepak 5 with Charger 03/31/99 407-327-7569 407 -977 -2602 List Price $13,700.00 {$1,595.00l ($400.00) Extended Price $54,800.00 ($4,785.00) ($1,200.00) Quoted by: Delivery: FOB: Terms: U. LL,./41V (j , / John Hawkins - Account Manager 800-648-1851 X247 Free shipping for orders over $500.00 Destination 2 % 20 OR Net 60 Days Thank you for your interest in Laerdal products. TOTAL Federall.D. # Quote Exp. Quote No. $48,815.00 13-2587752 60 days WINTERSP.IJI{~?:dal Medical Corporation, 167 My"r3 Co'ners hU2'::. P.O. Box 18-10. Wappingers Falls. NY 12590-8840 Telephone 19;-\} 29 '-~~70. Fax (914) 297-1137 Customer Ser'/ice (800) 431-1055. C,-,storner Serv;::e Fa, (800: ::27- 11,13 or (91-1) 298-4545. Sales Representatives (8001 048-1851 ~ laerdar helping save lives Winter Springs Fire Rescue 102 N. Moss Rd Winter Springs FL 32708 Attn: Chief Timothy Lallathin 03/31/99 Dear Chief Lallathin, This letter is in response to your question of the sole source distribution of the CodeMaster 100 Monitor/Defibrillator with 12 Lead. Laerdal Medical Corp. has been designated by Hewlett-Packard Corp. as the distribution channel for the product to the prehospital market segment (including Fire Depts. and Emergency Medical Services Providers), as indicated in our strategic alliance with theirs. The HP CM100 with 12 Lead ECG is the only portable Defibrillator/Monitor to incorporate advanced predictive instruments, and easy to use Qwerty keyboard controls. HP ACI- TIPI (Acute Cardiac Ischemia - Time Insensitive Predictive Instrument), TPI (Thrombolytic Predictive Instrument). 5 Year Warranty. HP ACI- TIPI uses a patient's age, gender, chest pain status and ECG features to analyze a patient and present a numerical score - the predicted probability of acute cardiac ischemia. HP TPI helps identify patients having acute myocardial infarction who might benefit from thrombolytic therapy. If we can assist you with any other matter, please do not hesitate to contact me at 800-648-1851 X247. Sincerely, f'k~/U/f. John Hawkins Account Manager Laerdal rvledlcal Corpora~IC1, 167 Myers Corners Road. P.O. Box 18-10. \Vappi""ers Falls. NY 12590-88-10 Telephone 1914) 297-7770. Fax (91.1) 297-) i37 Customer Service (800) 431-1055, Cusiomer Service Fax (8001 227-/1.J3 or (91-1) 293-.15-15. S,1!es Reoresentatives (800) (3.13-1851 .~ L9~rp~1 -dllo-' helping save fives March 17, 1999 LAERDAL MEDICAL CORPORATION NOTIFICATION ON YEAR 2000 COMPLIANCE Products: Laerdal Medical Corporation has conducted an internal review of all of our products for compliance for the Year 2000 date change. NONE of the Laerdal manufactured and/or distributed products pose any risk to patients, caregivers or end users. ALL Laerdal products (with the exception of the Actronics Training Sofuvare) will perform as intended with or without being updated, though some of the products may generate incorrect dates on reports after use. A complete listing of our products is attached, however, the following items have been identified as requiring some type of action to be Year 2000 compliant: Treatment Products 1. Heartstart 3000 (excluding QR and A TS models) display 2. Medical Control Unit (MCU) 3. Medical Control Module (MCM 2000 and MeN! Plus) 4. Heartstart Database Manager Training Products 5,. Actronics Training SofuvarelHardware Please call Laerdal's Customer Support Team at 1-800-431-1055 to arrange for your product(s) to be updated for Year 2000 compliance, if possible. Infrastructure: Laerdal Medical Corporation has done extensive research on our infrastructure to be sure that it will continue to support our ability to provide products and services. This includes our sofuvare systems and hardware platforms as well as our facility infrastructure and manufacturing processes. All of these items are either currently compliant or will be compliant upon the activation of our new operating software, planned for June I, 1999. In addition, we are in the process of querying our vendors to insure that they will be able to continue to provide Laerdal with quality products and services without interruption or malfunction throughout the century date change. Please visit our website, www.laerdaI.com. for more information as it becomes available. Laerdal Medical Corporation. 167 Myers Corners Road. P.O. Box 1840. Wappingers Falls, NY 12590-8840 Telephone (914) 297-7770. Fax (914) 297-1137 Customer Service (800) 431-1055. Customer Service Fax (800) 227-1143 or (914) 298-4545, Sales Representatives (800) 648-1851 LAERDAL PRODUCTS YEAR 2000 COMPLIANCE TABLE Product Type Product Name & Description " Y2K Attachment Compliant Training Family CPR Trainer Yes Training Little Annen..., Baby Anne™ Infant, Little Yes Junior™ CPR Training Manikins Training Resusci@ Anne, Resusci@ Baby, Yes Resusci@ Junior, CPR Training Manikins Training Recording Resusci@ Anne, CPR Training Yes Manikin Training Skillmeter, for CPR evaluation Yes Training Resusci@ Anne Skillguide, Resusci@ Yes Baby Skillguide Training Resusci@ Baby with Skillguide Yes Defibrillation Heartstart@ 1000, 1000S Automated Yes Treatment External Defibrillators Treatment Heartstart@ 2000 Automated External Defibrillator Yes Heartstart@ ECG SimulatorfTester Yes Treatment Heartstart@ Battery Chargers Yes Treatment Heartstart@ 3000 Automated External No A Defibrillators Treatment Heartstart@ 3000ATS, 3000QR Yes Automated External Defibrillators Treatment Heartstart@ Medical Control Modules No B Treatment Heartstart@ Check Module for HS3000 Yes Treatment Heartstart@ Medical Control Units - prints No C incident reports from cassette tape Treatment Heartstart@ Reporter - prints incident Yes reports from MCMs Treatment Heartstart@ Quick Reporter Charger - Yes prints incident reports from MCMs LAERDAL .\IEDICAL CORPORATIO;\' YEAR 2000 PRODUCT CO'IPLlA~CE TABLE CO~FIDE~TIAL PAGE10F3 Pro~uct Type Product Name & Description ". Y2K Attachment , .- Compliant - . . .. -' .- ' . Treatment Heartstart@ 911 Automated Defibrillator Yes . Treatment Heartstart@ Intelligent Power System - Yes sustains in-unit battery Treatment Heartstart@ FR Automatic External Yes Defibrillators Treatment HP/Heartstream@ ForeRunner™ Semi- Yes Automatic External Defibrillators Training HP/Heartstream@ ForeRunner™ Setup Yes and Training cards Training HP/Heartstream@ ForeRunner™ Yes CodeRunner Event Review Software and PCMCIA Data cards Treatment Hewlett Packard CodeMaster@ 100 Yes Portable Defibrillator/Monitor Treatment Hewlett Packard M2480B Battery Support Yes and Charging system Treatment Hewlett Packard CodeMaster@ 100 12- Yes Lead Portable Defibrillator/Monitor Training HeartTesFM RST3, RST-12 Rhythm Yes Simulators Treatment Heartstart@ DataBase Manager No D Treatment HeartMaster™ Event Data Management Yes System Treatment Heartstart@ Electrodes Yes Training Early Defibrillation Training Manikin, with Yes Skill meter and Mini-Heartsim™ Training Laerdal@ (HS911) AED Trainer Yes Training Heartsim@ 200 Cardiac Rhythm Yes Simulator Training Heartsim@ 2000 Cardiac Rhythm Yes Simulator and Program Modules Training Laerdal@ Monitor Interface Yes Training ALS BabyTM, Basic ALS, Advance ALS Yes Trainers LAERDAL MEDICAL CORPORATlO:"i YEAR 2000 PRODCCT CO:\ll'l.IA:"ICE TABLE CONFIDENTIAL PAGE 2 OF 3 Product Type Product Name & Description Y2K Attachme~t , Compliant .~ Training IV Trainers Yes Training HeartCode".l Adult Airway manikin and Yes interface box Training HeartCode,M ACLS Courseware Yes Training Actronics Software/Hardware Systems No E Training HeartSim™ Interactive Training System - Yes courseware, manikin & interface box Training HeartSim™ 4000 Rhythm Simulator Yes Airway Laerdal@ Silicone Resuscitators, The Yes BAGTM Disposable Resuscitators Treatment Laerdal@ Pocket Mask™ and Resusci@ Yes Face Shield Treatment Laerdal@ Premier™ Suction Unit, Yes Laerdal™ Suction Unit, Laerdal™ Compact Suction Unit Treatment V-VACTM Manual Suction Unit Yes Training Laerdal@ Airway Management Trainer Yes Training Laerdal@ Infant Intubation Model Yes Treatment Trachlight@ Stylet and Lightwand Yes Spinal BaXstrapTM Spineboard Yes Treatment Stifneck@ SelecFM and Stifneck@ Yes Extrication Collars Treatment Headbed™ II Cervical Immobilization Yes Device MPL Products Skeletons, Skulls, Spines, Hearts, Brains, Yes Training Manikins, Trauma, and IV Training Products Training Multi-Sounds Trainer Yes Training Arrhythmia Scenario Trainer Yes Treatment LAERDAL MEDICAL CORPORATlO.'i YEAR 2000 PRODCCT CO.\IPLI.-\:'-iCE TABLE CO~FIDE.'iTIAL ".-\GE 3 OF 3 ( HP __ Speed of Life) --~?ij:;;f~~~r\~ )~, IifEj PAC'K-ARD When it comes to treating and trans- porting patients. the HP CodeMaster 100 is in a class by itself. It delivers the quick charging. dependable performance and advanced features you expect from an HP defibrillator/monitor - all in a durable. water-resistant unit built to \\ithstand the rigors of emergency use. The HP CodeMaster 100 is a versa- tile defibrillator/monitor forBLS- and ALS-trained personnel alike. BLS responders \vill appreciate its true 1-2-3 operation. intelligent battery support system. easy-to-use pads for hands-free defibrillation. and optional shock advisory - which signals whether a rhythm is shockable or not and guides users through the process. ALS responders ....ill value the.HP CodeMaster 100's advanced manual defibrillation. integrated .pu1se oximetry. non-invasive pacing. synchronized cardioversion and other advanced features that put them in complete control. Best of all. 12-Lead ECG. predictive instruments and interpretation are all available on the HP CodeMaster 100 - to speed diagnosis of acute cardiac ischemia and other cardiac arrhyth- mias. and reduce time to treatment. HP has been a leader in electrocar- diography. defibrillation and moni- toring for more than 35 years. Now. with the HPCodeMaster 100. we take life-saving technology to the next level. . . ...' -. ~ .... -.. ...... -., ... ". ,. ~. .-.. -,........ '-- . '. .. . , ,.. . \. \ . \. I \. ~ ..... , ,., '.'" f \... . ~ ".' . Early 12-Lead ECGs reduce time to treatment. In the United States alone. over one third of the L.5 million people who suffer heart attacks each year die. And even more will experience diminished lives due to the resulting damage. Why? Because it took too long to get the right care. Clinical studies show that early treatment using thrombolytic agents can significantly improve outcomes for patients suffering from acute myocardial infarction (Atvfi) - especially if administered within one hour of symptom onset. Obtaining 12-Lead ECGs in the field has proven to be the most effective way to reduce time to treatment. Thanks to this advanced technology, a patient is more likely to be trans- ported to a hospital with the most appropriate facilities. And the emer- gency department is more likely to be prepared once the patient arrives. The right solution - anytime, anywhere. The HP CodeMaster 100 with 12-Lead ECG and predictive instruments allows emergency medical personnel to view, acquire, store. print, fax and transmit .l2-Lead ECGs. Paramedics can send a patient's L2-Lead ECG by landline or cellular phone to an emergency department, where a physician can overread it and be ready to deliver treatment upon a patient's arrival. The result? Using 12-Lead ECGs in pre-hospital medicine improves door-to-treatment time, as well as patient outcomes. ..,. - . -_\. -.-'. ,..ou '-"\.&"'_"\. ....\., \."" I I .' "".;-'111'" '" ...'"";"'.+..1'...... I ....... I T""',- I .. 1\.:- ., I ," _ t ........ I I t ~ ~ . :"'. ' . .. . , . , .Ii II, "._: r~,l.."" .1t'11..' ". 1(.'.... The only defibrillator! with predictive instrum The HP CodeMaster L 00 \ ECG is the only portable monitor to incorporate a predictive instruments TIPI (Acute Cardiac Isch Time-Insensitive Predict' ment) and HP TPI (Thro Predictive Instrument), HP ACI-TIPI uses a patie gender, chest pain status features to analyze a pat present a numerical scor predicted probability of diac ischemia. It's an ad you can use to support y decision. HP TPI helps Identify pa " , lng acute myocardial inf might benefit from thro therapy - recommende the American Heart Ass the National Heart Attac Program. HP TPI pro\;d HP Codelvlaster 100 With 12.Lead lets 'f qll'Ck,y p-ev ew all 12 leads. any three ; time. to ver fy [eG quailty tJe{cre rewd 8 8 SO" =- .- ====-- .~ ':::=- '> ':=> :> -=- ;;> tv V. 8 8 - '" -~~- < < v. ... I t 1 ~ o =- =- .=- " ;' ;-[f . ~ 1- ,:0 < ... < -, -=.::--' -1 . - I i i I i I I I i _ ..__. __-J -- IliOn. repcrtS ~lIl1lar phone the ED ~ via fax llcally to a eMaster il~tW~>:- - . ::,:~:,:,-:"",~,,:, &I - ...~.. .'\ ..... .,'\ .,.~.. '..' ; I " ! . .":-" : I. . _', '..:",.. : \. ~ '..... I '.~.' .,t ", I I" I . ..... . ; : _, "', .~ ;" I . !. _ :\! '. I.: -:'l r,,-t:\ . ... ... . . '_~ . _' 1...", ',' I.",. \ ...., \ \ 1 I 'I... ..... . Ct..';< ~ . .'. ~.~.", 1f1i.~~' .J/ y:~( ~, ,. I e~,,~ . Acquires. stores. transmits and prints simultaneous 12-Lead ECGs. . HP ACI-TlPI predicts the probability of acute cardiac ischemia in chest-pain patients, . HP TPI identifies those who might benefit from thrombolytic therapy. . Displays all 12 leads, any three at a time, to verify ECG quality before recording. . Incorporates HP's advanced adult and pediatric analysis programs. . Reports clearly labeled with ECG data and patient information entered via the QWERTY keyboard. . Stores up to 30 12-Lead ECGs intemally. . Transmits ECGs to a receiving station using landline or cellular telephone via intemal modem (US, Canada and UK only). or external modem in other countries. The durable carry bag is engineered and manufactured to absorb the bumps and scrapes of transport. ~ ~t-. \ 1 t fi)~.~.~,,~.~4.. i lh~"?: H? C.C(iC:\.;t1':r.f'~ :c!() ~ ~. re3t\Jre\~ !..)'.:(';'.::~.;\/:: r,\ S I . Quick Charging. Charges From 0 to 360 joules in under 5 seconds. r;\SY 10 U~;r-: . True 1-2-3 Operation. Easy to learn, easy to use, speeds response in an emergency. . Event Summar::!. Documents and stores up to 28 events, even holds data aFter the unit is turned oFF. . Advisor::!.tvent Summary. Documents and stores up to 50 ECG strips and 200 events in the advisory event summary mode- included with Shock Advisory. . Large CRT Display. A bright S-inch screen makes it easy to read user-Friendly messages and monitoring inFormation. . Leads-oFf IndicatOl'. HP defibrillatorl monitors display a dotted line on the display when a lead becomes disconnected. . Paddle-to-Patient Contact Indicator. Reduces guesswork by telling you whether you've applied enough pressure to successFully defibrillate a patient . Uncluttered Front PaneL Contributes to easy operation and Fast response. POi'leRfUL . Long-Lasting Battery. Comes with a 25 hollf'. NiCd quick-charge battery. (4-bourbattery.optionaO. . Intelligent Battery Support System. Eliminates the "memory eFFect" that takes place .when batteries are partially dis- charged. then recharged again and again. Automatically indicates when it's time to recondition the battery. . Battery Capacity Gauge. Indicates battery cha~ level. so you know when it's running low. . Optional AC Power. The AC power module allows it to be plugged into a standarn AC wall socket For use in the hospitaL . Optional DC Power. The 12-volt power module is ideal For long-term monitoring or as a batter::! charger in emergency vehicles. ~r.YC\c. THC BA<JIC:. . Monitoring. Use the HP CodeMaster 100 as an ECG bedside monitor when a separate unit isn't available. . Hands-Free Defibrillation. Allows you to defibrillate remotely through multi- Function electrodes for maximum.safety. . Integrated Pacing Option. Pace and defibrillate through the same multi- Function electrodes. . Integrated Sp02 Monitoring. Measure and monitor Sp02 levels to help determine when mechanical capture occurs. . Auto Gain. Automatically sizes ECGs on the display. . Adjustable Heart Rate Alarms. .Alerts you to any changes in a patient's condition. . . Easy-loading Thermal Array Recorder. Prints critical patient data - date. time. heart rate and more. . Built-in Pediatric Paddles. Available under slide-oFF adult paddles, so there's no extra equipment to carry. ,1;.;!ll TO l:'fRFOfU.\ . Durable, Water-Resistant Case. Engineered and manuFactured to absorb the bumps and scrapes of transport . High-Visibility Yellow Case. Makes.it easy to locate in an emergency. . Built-in Diagnostics. Lets you know when the unit needs to be serviced. . HP$upport. HP Customer Support keeps your HP.CodeMaster 100 up and running. 24-hour telephone support means help is always just a phone call away. . . 5-Year Warranty. Backed by HP, with more than 35 years of clinical leadership. o Pil Q~: S . 12-lead ECG. Acquires high-quaUty 12-Lead ECGs at the touch of a button which can then be stored, transmitted and printed. . Predictive Instruments - standard with the 12-Lead option. HP AO-TIPI-helps predict the probability of acute cardiacis.chemia HP TPI- helps predi<t outcomes of throm- bolytic therapy in AMI patients. . Shock Advisory. lets you know whether arhythm is shockable or not and guides you through t~ess of deftbritlation- all on screen. lf7EJ ~~C'K-~~D For more information, please call your local HP sales office or an HP regional office listed below. United States: Hewlett.Packard Company /o.ledical Products Group Headquarters 3000 Minuteman Road Andover. MA 01810 Medical Customer Information: 1.800.934.7372 Canada: Hewlett.Packard (Canada) Ltd. 5150 Spectrum Way I\lississauga. Ontario L4W 5G I (416) 206.4725 Asia Pacific Headquarters: Hcwlett.Packard Asia Pacific Ltd. J7.2IfF Shell Tower. Times Square I Matheson Street, Causeway Bay Hong Kong (852) 2599 7777 Latin America: Hewlett.Packard Latin America 5200 Blue Lagoon Drive 9th Floor Miami. FL 33126 (305) 267.4220 Marketing Center Europe: Hcwlett.Packard GmbH Herrenberger Str. 140 71034 Boeblingen Germany Fax (49) 7031 144096 Medical Distribution: . Europe, Middle East, Africa 39 rue Veyret 1217 MeyTin I. Geneva, 'Switzerland (41) 227804111 Visit us on the .....-eb at: www.hp.comlgo/heart For life-saving Informati.on about Sudden Cardiac Arrest (SCA). please visit our educational web site: www.chalnofsurvlval.com i\ote; For specific, detailed information. please consult the HP CodeMaster 100 lser's Guide and/or Technical Data Sheet. Caution: In the U.s.. federal law restricts this de.,ice to sale on or by the order of a physician. The Informarion contained In this document Is subject [0 change without notice. . C 1998 He.....lett.Paekard Cnmpany. AU Rights Reserved. Printed In USA 10/98 Part Number 5968-2303E HEwun PACKAPO [~~!o~!.~, HP CodeMaster 100 Defibrillator First to Offer Pre-hospital 12-Lead ECG with Predictive Instruments Palo Alto, California. Nov. 3, 1998 Hewlett-Packard Company today introduced the industry's first defibrillator with prehospital 12-lead ECG and predictive instruments. The new HP CodeMaster 100 with 12..,}ead electrocardiogram (ECG) capabilities, designed to speed diagnosis and treatment of heart-attack patients, provides enhanced decision-support capabilities in the field. Using the new HP CodeMaster 100, paramedics and other ALS.(advanced life support) personnel can capture a 12-lead ECG in the field, as well as use predictive software to calculate the probability of acute cardiac ischemia (ACI), and mortality and complications with and without thrombolytics for patients with ECG-detected acute myocardial infarction (AMI). HP's predictive instrument algorithms were developed in conjunction with Dr. Harry P. Selkerofthe New England Medical Center and Tufts University School of Medicine, Boston. The HP Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI)on the.HP CodeMaster 100 calculates the predictive probability of ACI, which includes unstable angina pectoris and acute myocardial infarction, on a.percentage scale by combining 12-lead ECG analysis with patient age, sex and chest-pain status. The HP Thrombolytic Predictive Instrument (TPI) is designed to .assistin identifying patients who .have AMI and might benefit from thrombolytics -- "clot-busting" drugs. The TPI algorithm uses a combination of the ECG, patient age, sex, weight, blood pressure, patient .history, and time since .ischemic onset tD predict the probability of cardiac .arrest, mortality with and without thrombolysis, and the probability of a major bleed and intracranial hemorrhage resulting from thrombolysis. Using the HP CodeMaster 100, paramedics in the field can transmit the 12-lead ECG and probability scores via landline or cellular communication to an emergency department (ED). The 12-lead reports can be received by fax or HP ECG Manager PC software. With this information, clinicians in the ED can help accelerate assessment and triage of patients before they reach the hospital -- saving time and preserving heart muscle. "As clinicians seek new ways to decrease door-to-drug times, predictive instruments in the field .offer an additional layer of decision support beyond a 12-lead strip," said Steve Rusckowski, general manager of HP's Cardiology Products Division. "This new functionality will help further reduce the time to intervention and is a valuable tool for expanding the administration of thrombolytics." 1 01'3 3/11/998:50 PM According to the National Heart. Attack Alert Program,. obtaining a 12-lead ECG on patients in the field is a key factor in reducing time needed to identify and treat heart-attack patients. The American Heart Association and European Congress of Cardiology agree that all eligible patients should receive thrombolytic therapy within a short time after arriving in the emergency department. Thrombolytic therapy has been shown to reduce mortality by 20 percent to 52 percent and to improve left ventricular function significantly. The greatest benefits ofthrombolytics, however, have been observed in patients who receive therapy within 70 minutes of the onset of symptoms. The lIP CodeMaster 100 with 12-lead ECGretains the.originalfeatures that have made.it a success in the prehospital market, including the fastest charge time and true 1-2-3 operation. The integration of 12-lead ECG includes a large display and alphanumeric keyboard. In addition, an internal modemis.currently available in the United States and Canada. The new HP CodeMaster 100 with 12-lead ECG is available worldwide through lIP and its alliance partner Laerdal Medical Corporation. About HP's Medical Products Group lIP's Medical Products Group is a worldwide leader of clinical measurement and diagnostic.technologies, .information solutions, services, support and supplies for the healthcare industry. The group has 4,800 employees and had revenues of more than $1.2 billion in its 1997 fiscal year. HP leads the world in acute-care patient monitoring, cardiovascular ultrasound imaging. and clinical-inf.ormation systems for critical care, and is at the forefront of new technologies such as point-of-care diagnostics and predictive instruments. lIP is the founding member and chair of the Andover Working Group, a 300.,member initiative focused on developing standards-based interopecability between healthcare applications. Information about lIP Medical Products Group can be found on the World Wide Web at About HP Hewlett-P4ckard Company is a l~ading global provider of computing; Internet and intranet solutions, .services, .communications products and measurement solutions, all of which are recognized for excellence in quality and support. lIP has 127,200 employees and had revenue of $42.9 billion in its 1997 fiscal year. Information about lIP and its products can be found on the \Vorld Wide Web at http://www.hp.com/. Editorial Contacts: Kelly Peavey, HP (978) 659-4351 Tony Labriola 20fJ 3/11/99 8:5\ PM Mullen PR forHP (978) 468-1155 x 127 Note: HI' press releases are archived on this Web site for historical purposes. Information in the releases is accurate at the time of release. However, .productspecifications and availability, promotions, .prices, .relationships, contact numbers aud other. specific information may change over time. Some information about product pricing and availability may be limited to specific geographic ;ireus and may differ in other areas. Infonnatwn as stated in the release mayor may not be in. effect after the.date,oll the release. Iu additiou,4e press releases may contain statements that are forward-looking. These statements arebased{)u current expectations as of the date of a particular release. Actual results may differ materially from those projected because of a number of risks and uncertainties. including those detailed from time to time in HP's reports filed with the Securities and Exchange Commission. Click here to review these that could cause results to differ materially from those in any such forward-looking statements. ~ - ~ = -.l( "'" '\>:.. , -."i'...:.... .' '. ..',. ~~.'; .. ."'~~~i"" o\c':; :-':";'.':',.,..;,.' . ..... ,.;. - ';.,. . :L\~; ~> ;=;7~~~;~;~~.~~;'1:~::J .: . . . . ~ . .... . .' . .. .,' . '. .' Ute of thr~ ~ite indkill,;.s &1M you accept th~ . t.." ~ ~~.,~ ! H~\.I::TT PACKAI'IO .t COP!Jng~ 1')<).j.Y.i9g H~wle-:r-Patkard Ccr.'i;)~y (c) Copyright 1998 Hewlett-Packard Com pan)'. 30D 3/11/99 8:52 PI\\ HP M2475B CodeMaster 100 Portable MonitorfDefibrillator Technical Data Sheet Features · Shock advisory with advisory (optional). · Charges. from 0 to 360 joules in less than five seconds with fully charged battery. · True 1-2-3 operation, standardized with other HP CodeMasterdefibrillators. · Large CRT display offers clear view in multiple applications and environments. · Built-in pulse oximetry. · Built-in non-invasive pacing. · Battery capacity gauge indicates battery .charge level. · Event Summary documents pre-and post-critical event data. · High-visibility yellow case for fast, -easy recognition. · \Vater-resistant. · Durabl.e design and extra-rugged materials made to withstand. everyday-bumps and scrapes. · Paddle-to-patient contact indicator reduces guesswork. · Adjustable heart rate alarms. · Standard battery powers 50 .fuU-.energy .discharges or2.5 .hours ECTmonitoring. · Built-in pediatric paddles immediately available under. slide-off adult electrodes. · Hands-free defibrillation c~pability .included: · 12-volt power module for long-term monitoring and battery charging in emergency vehicles ( optiol)al). · 5-year warranty standard. ~.p'i~'d~~i.~~.;hAi.~;y : Specifications Defibrillator Waveform: Damped sinusoidal (Lown). lof7 3/11/998:38 PM Output Energy (Delivered): 2, 3, 5, 7, 10,20,30,50, 70, 100, 150,200,300, and 360 joules. Charge Control: Push-button on apex paddle and on front panel. Charge Time: Less than 5 seconds to 360 joules with a fully charged battery installed. Armed Indicators: Charge done tone,.charge done light on apex .paddle.and on defibrillator front panel, and available energy indicated on display. Paddle Contact Indicator.(PCI): 3.,color LED bar .graph .array on STERNUM paddle indicates quality of defibrillator paddle contact before discharge. Paddles: Standard paddles are water.,resistant anterior/anterior,adultand.pediatric, with .PCL Adult electrodes (83 cm2) slide off to expose pediatric electrodes (21 cm2). Paddle cord is lOft. (3 m). Synchronizer: SYNC message appears.on monitor.and is.annotated periodically.on recorder while.in synchronous mode. An audible beep sounds with each detected R-wave, while a marker on the monitor and sync designator on the recorder strip indicate the discharge point. Monitor Shock Advisory ( optional): Allows CodeMaster 100 to be used as an advisory or "semi-automatic" defibrillator. Inputs: ECG may be viewed through paddles or patient .cable. .Lead I, II, III, or P ADDLE SIP ADS . selectable. Additional.leads (aVR, aVF, ~VL, V leads) are available. Monitor and recorder indicate selected ECG source. Lead Fault: LEADS OFF .message .and dashed baseline .appearon .monitor if aJead becomes disconnected. Common Mode Rejection: Greater than 90 dB measured as per AAMI standards for cardiac monitors (EC 13). Display Size and Type: 5 inch (12.7.crn).diagonaICRT for 4 .secondsofECG.data.on screen; non-fade, fixed trace. Scrolling trace is selectable. Sweep Speed: 25 mm/sec nomi~a1. Frequency Response: 0.5 to 40 Hz. Heart Rate Display: Digital readout on monitor from 15 to 300 bpm. Heart Rate Alarms: Three configurable pairs of high and low heart rate alarm limits from 20 to 280 bpm. ECG Output: 1 V/mV. Patient Cable Length: 10 ft. (3 m). 2of7 3/11/998:39 PM Thermal Array Recorder Annotates; Time, date, HR, event marker, ECG mode, .defibrillator mode, selected.energy,actual delivered energy, peak current, patient impedance, Sp02 and pacing current and rate. Recorder :Mode: Automatically documents events. and ECG during defibrillation episodes. The recorder can be configured to run in either real time or with a six-second delay. Speed: 25 mrn/sec. Paper Size: 50 mm by 30 m (100 ft). Frequency Response: 0.5 to 40 Hz or 0.05 to 150 Hz selectable. Event Summary: Stores and prints 3 seconds pre- and 8 seconds post-critical event data for up to 28 events. Data retained after unit is turned off Advisory Event Summary (with shock advisory):. Stores approximately 200 events and up to 50 ECGs. Data retained after unit is turned off. Battery Standard Type: 2.5 Ah NiCd. Dim~nsions: 3.3 in H by 3.0 in W by 7.3 in D (8.4 cm H by 7.6 cm W by 18.5 cm D). \Veight: 2.71b (1.2 kg). Charge Time: Approximately 2 hours to 100%. Capacity: 2.5 hours ECG monitoring or fifty (50) full-energy discharges or 1.75 hours combined ECG and Sp02 monitoring while pacing. Battery Indicators: LOW BATTERY message appears on monitor when approximatdy30 minutes of battery capacity remain. .. Capacity Gaug~ LED system built into battery pack gives operator visual indication .of remaining battery cl1arge. Also available Type: 4.0 Ah NiCd. Dimensions: 3.3 in H by 3.0 in W by 7.3 in D (8.4 cm H by 7.6 cm W by 18.5 cm D). Weight: 4.3 lb (1.9 kg). 30f7 3/11/998:-10 PM Charge Time: Approximately 3 hours to 100%. Capacity: 4 hours ECG monitoring or seventy-five (75) full-energy discharges or J hours combined ECG and Sp02 monitoring while pacing. External Pacemaker Current Pulse Amplitude: 10 mA to 200 mA. Pulse \Vidth: 20 msec. Rate: 40 ppm to 180 ppm. l\'lodes: Demand or fixed rate. Refractory Period: 40 to 80 ppm 340 ms; 90 to 180 ppm 240 ms. Pulse Oximeter Sp02 l\'leasurement Range: 0 to 100%. Accuracy with HP M1190A Sensor: 1 standard deviation. 65% to 80%: +/- 2.5% 80% to 100%: +/- 1.5% Resolution: 1 % Accuracy with Nellcor Sensors: 1 standard deviation. N-25, 1-20, D-20, D-25, Oxiband AIN, OxibandPII: 80% to 100%, +/- 3% (requires option #C74 adapter cable for Nellcor sensors). Sp02 Alarm Limits: Three pr~set ranges ofhigh/low alarms: 100/90, 100/85, 100/80. Default = Off. Pulse Amplitude Indicator: Indicates pulsatile activity. Pulse Rate Measurement: Range: 30 to 300 bpm Accuracy: +/-1% Resolution: 1 bpm En l'ironmental Operating 401'7 3/11/99 8:40 PM Temperature: 0 to 550 C. Humidity: 15 to 95% for 24 hours at 400C. Altitude: 15,000 ft. Shock: MIL-STD 81 OD, Method 516.3, Procedure 1 (functional). Vibratiqn: MIL-STD 810D, Method 514.3, Figure 514.3-28 (Cat. 6), Helicopter (UH-60). 'Vater Resistance: IEC 601-2-4, splash proof per IEC 529 IPX4. Storage Temperature: -20 to 700 C. Humidity: 90% for 24 hours at 650 C. Altitude: 15,000 ft. General Dimensions: 6.25 in H by 13.75 in W by 15.13 in D (15.9 cm H by 34.9 cm W by 38.4 cm D). 'Veight: 21.5 Ib (9.8 kg). Includes paddles, standard 2.5 Ah battery, Sp02 , pacer, and recorder paper. Standard Accessories Water-resistant Paddles with Paddle Contact Indicator 3-Lead ECG Patient Cable Disposable Monitoring Electrodes Water-resistant Adhesive Pads Adapter Cable (M2472A) Recorder Paper, Spare Roll (40457C for package of 10 rolls) User's Guide Quick Reference Guide ;2{. ~ Training Video Tape VHS-NTSC Training Video Tape VHS-P AL Sp02 Concepts Guide l~ ( '3 · 33 ~i\. IOu) \' ~.W- '\ I:' ~&-v ~ . \'\. Sp02 Sensor Guide Redux P~ste (651-1008-010) 2.5 Ah NiCd Battery (M2476B) 5of7 3/11/99 8:-11 PM -ProdU<:(S~;n~a~y. ~""." -, .'. - -.. ....~....... '. Ordering Information Options C30 6-pin AAMI ECG connector; includes AAM1 3-lead cable C31 6-pin AAMI ECG connector with AAMl12-lead 5-wire cable C32 12-pin HP CMS ECG connector; includes AAM13-lead cable C33 12-pin HP CMS ECG connector; includes AAM1 12-lead 5-wire cable C34 12-pin HP CMS ECG connector; includes IEC 3-lead cable C35 12-pin HP CMS ECG connector; includes IEC, 12-lead 5-wire cable C36 AAMI, 12-lead 5-wire ECG cable C37 IEC, 12-lead 5-wire ECG cable C51 Defibrillator carrying case with accessory pouch C52 Accessory pouch C73 Adult finger Sp02 sensor C74 Ad~pter cable for Nellcor Sp02 sensors C76 Additional 2.5 Ah NiCd battery en AdcFtional4.0 Ah NiCd battery C78 Substitute 4.0 Ah NiCd battery instead of2.5 Ah battery C80 Shock advisory JOt Add 8-pin SYNC cable J02 Add 6-pin AAMI SYNC cable J03 Add 12-pin HP CMS SYNC cable OB3 Service manual OBR Service training video tape, VHS/NTSC 60f7 3/11/998:41 PM OBS Service training video tape, VHS/P AL Additional Accessories l\t12480B External NiCd battery support system (required for battery charging and reconditioning) l\t11749A Multi-function electrode pads, adult AAMl l\t11749B Multi-function electrode pads, adult IEC l\t11749C Multi-function electrode pads, pediatric IEC 1\'11 749D Multi-function electrode pads, pediatric AAMI l\t12478A 12-voltpower module for use in emergency vehicles Click here to order at your local H P Sf tIes oftk.;-. .. .-. ... ---.." ... .. .--.- -.--- ------.-....... ~-.- --. __ ."_ -__..__"._..._..____n.." .__ 0._ .__. .._._.. ___.____..._....._ __' ."...__._.__ _ .___.._._ _.. ... ."_ '_...______ _ ...._ _ _,,'__.'_',_ U This data sheet is available in Adobe Acrobat format. Click here to do\vnloi1d the Acrobat versior: (jfthi~ data sheet - - n_.. -- ... -' .---." ...... ._. -. ".-.-_ .....-.--. . -_. _. _ ........_._ ___ .... n._ _.. . ..._ .. _0_,_ ...' .'_'." _. _... . ...... . ... ..... ."... . h_ _..._~ . _. _ .._ _.. ..... _..__ 0'_'" M.. . _ . _. . _. .._. _.. ".. 0.. Updated 11/19/98 19:58:28 7of7 3/11/99 8:42 PM rhfl'l HEWLETT' ~?-JI PACKARD Thrombolytic Predictive Instrument (TPI) HP TPI for PageWriter XLi (M1792A Option C01)** HP TPI for PageWriter 300pi (M1792A Option C02) HP TPI for CodeMaster 100 (M2475B Option C90)* Technical Data Description The Hewlett-Packard Thrombolytic Predicti ve Instrument (TPI) is a soft- ware program that enhances the com- puter-assisted ECG analysis capabilities of the HP PageWriter 300pi and the HP PageWriter XLi cardiographs. It is designed to aid the decision-making process of physi- cians in the pre-hospital and Emer- gency Department setting iq identifying patients having acute my- ocardial infarction (AlVII) who might benefit from thrombolytic therapy. Patient age, gender, time since is- chemic symptom onset, history of di- abetes, history of hypertension, blood pressure, weight, and ECG features are used to predict patient outcome probabilities for short-term mortality; . long-term mortality, cardiac arrest, and complications associated with thrombolytic therapy. Features The Thrombolytic Predictive Instru- ment: Fully implements the Throm- bolytic Predicti ve Instrument analysis program. Automatically assesses ECGs for evidence of acute myocardial infarction to identify throm- bolytic therapy candidates. Automatically detects the approximately 25'70 of patients with chest pain that actually have At"!!. Detection triggers the appropriate data entry screen to produce a HP TPI analysis report. Provides a HP TPI analysis report in an easy-to-read tabular format. Can be enabled or disabled through standard configuration controls and can be selected at any time from the main report selection menu.. Reports results with regard to two degrees of Al\H evidence: definite and possible. Automatically reports the pre- dicted probabilities of patient outcome: short-term mortality, long-term mortality. cardiac arrest, and complications associ- ated with thrombolytic therapy (intracranial hemorrhage and other major bleeds). Provides ECG reports which can be permanently stored on the HP TraceMaster ECG Management System and HP ECG Manager. **Note: Available on the Page'Vriter XLi in 1999. Cardiography HP TPI The Hewlett-Packard Thrombolytic Predictive Instrument (HP TPI) pro- vides physicians with an additional tool in identifying patients with acute myocardial infarction (AlVII) who might benefit from thrombolytic ther- apy. Aiter answering a series of questions, the physician is presented with pre- dicted probabilities of patient out- come: 30 day mortality (with and without thrombolysis), 1 year mortal- ity (with and without thrombolysis), cardiac arrest within 48 hours (with and without thrombolysis), thrombol- ysis-related intracranial bleed and other types of thrombolysis-related major bleeds. The clinical features entered by the clinician include: pa- tient age, gender, time since ischemic symptom onset, history of diabetes, history of hypertension, blood pres- sure. and weight Three ECG features which are taken from the computerized analysis of the electrocardiogram are examined. They are: presence and degree of ST segment elevation or depression, presence or absence of abnormal Q_ wa ves, and the presence and degree of T-wave elevation and inversion. ECG features must be apparent in at least two related leads and not due to noise. artifact or any of the five ex.clu- sionary cases which can skew ECG interpretation repolarization abnor- malities secondary to L VH, REBB, LBBB, anificial pacemaker or early repolarization. \Vhile none of these ECG features alone is diagnostic, to- gether they represent the most promi- nent ECG features for predicting Ai\-! I. A vailable Reports A printed HP TPI report contains the TPI analysis statements based on de- gree of AMI evidence: definite and possible. An optional second section contains standard adult ECG criteria statements. In general, patient ECGs meeting "definite" AMI criteria have ST seg- ment elevation in two or more related leads well exceeding the commonly used thresholds (2mY in the pre cor- dial leads and ImY in the limb leads). Patient ECGs meeting possible AMI criteria have somewhat elevated ST segment not consistent with normal variants. This may include significant reciprocal ST depression in opposite anatomic regions or abnormal ST seg- ment elevation across a wide region of the leads. Predictive Instruments Predictive instruments are appropri- ate for medical situations where clini- caljudgment is dependent upon a number of diagnostic variables. This type of mathematically-based deci- sion aid is useful in critical care situa- tions where speed of diagnosis can be critical. HP TPI uses a logistic regression mathematical formula that, based on patient age, gender, time since is- chemic symptom onset, history of di- abetes, history of hypertension, blood pressure, weight, and ECG, to com- pute predicted probabilities of patient outcome. These predicted probabiJi- ties are: short-term mortality, long- term mortality, cardiac arrest, and risks associated with thrombolytic therapy such as thrombolysis-related intracranial bleed, and other types of thrombolysis-related major bleeds. The HP TPI algorithm and report are implementations of work:by Harry P. Selker, M.D., of New England Medical Center, and his col- leagues. Dr. Selker is a clinician and researcher who has worked for many years in hospital Emergency Depart- ments, and directs a research center that studies ways to improve emer- gency care through decision aids. The development of the TPI instru- ment resulted from Dr. Selker's rec- ognition of the need to increase the Emergency Department (ED) physi- cian's ability to quickly and correctly identify patients with acute myocar- dial infarction (Ai\1I) who might ben- efit from thrombolytic therapy. By analyzing the Emergency Department triage process, his research team was able to detennine which factors led to best decisions. These factors were incorporated into the fonnula. Extensive work on TPI has been done in consultation with Dr. Selker to produce Hewlett-Pack- ard's application ofTPI for the Page- Writer XLi and 300pi cardiographs and the HP CodeMaster 100 monitor- defibrillator with 12-Lead ECG. Physician Use Like any computer-assisted ECG interpretation program, HP TPI evaluation is intended to supplement, not substitute for the physician's decision process. The results must be considered in context of contradictions of thrombolysis and conditions that mimic acute myocardial infarction. It is best used in conjunction with knowledge of the patient's history, the resu Its of the physical examination, the ECG tracing, and other findings. The range of predicted patient outcome probabilities produced by HP TPI is ex.pressed in a percentage from 0% to 100%. Specific ranges of predicted probability and probabiJity ratio of benefit versus risk are not represented as indicating specific treatment decisions such as "administer thrombolytics" or "send the patient home". Specific ranges are meant to be utilized at the physician's discretion, and the meaning of any panicular number or subset must be defined by the physician. Ordering Information Model M 1792A Option CO I is com- patible with HP PageWriter XLi car- diographs using version A.05.00 or later operating software. Model M 1792A Option CO 1 includes appli- cation software on a 3.5 inch diskette (which is installed by the customer), Quick Reference Guide, and Predic- tive Instruments Physician's Guide. Orderable as the HP M3548A Predic- tive Instrument Upgrade. Model M 1792A Option C02 is com- patible with HP PageWriter 300pi interpretive cardiographs. It comes installed on the PageWriter 300pi and includes a Quick Reference Guide and a Predictive Instruments Physi- cian's Guide. *The HP TPI software program has been incorporated into the HP CodeMaster 100 monitor- defibrillator for use in pre-hospital emergency settings. HP TPI is designed to aid physicians and paramedics in the pre-hospital environment The TPI report can be selected by the user, generated on the CodeMaster 100 monitor- defibrillator with 12-Lead ECG, transmitted to the hospital Emergency Department for physician overview, and stored on the HP TraceMaster ECG Management System and the HP ECG Manager receiving station. The CodeMaster 100 12-Lead ECG option includes TPI and can be or- dered as M2475B with option C90. For more information, please call your local HP sales office listed in your telephone directory or an HP regional office listed below for the location of your nearest sales office. United States: Hew(ett-P:!ckard Comp:lJlY Medic:!1 Products Group He:ldquarters 3000 Mnutem:!ll Road Andover. MA 01810 Medical Customer loIormalion 1-800- 934-7372 Canada: Hewlett-P:!ckard (Canada) Ltd. 5150 Spectrum Way Mississ:!ug:l, Oot.1rio L4W 501 (905) 206-4725 Latin America: Hewlett-P:!ckard Luin Amenc:! 5200 Blue Lagoon Drive 9th Floor Miami. Fl 33126 (305) 267-4220 Marketing Center Europe: Hewlett-Packard GmbH Schickardstr. 4 71034 Boeblingen Germ:l!1Y Medical Distribution Distribution Europe. Middle Ease. Africa (+41) 22 1804111 Asia Pacinc Headquarters: Hewlett-Packard Asia Pacific Lcd. 17-211F SheU Tower, Times Square 1 Matheson Street, Causeway Bay Hoag Kong (+852) 2599 7777 The information contained in Ih,:r document iJ .ruhjectto change without notice. Hewlett-Packard Company 1998 Printed in USA 8/98 596~OE rhii'l HEWLETT' ~~ PACKARD Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) HP ACI-TIPI for PageWriter XLi (M179lA Option COl) HP ACI-TIPI for PageWriter 300pi (M179lA Option C02) HP ACI-TIPI for CodeMaster 100 M2475B (Option C90*) Technical Data Description The Hewlen-Packard Acute Cardiac Ischemia Time-Insensiti ve Predictive Instrument (HP ACI-TIPI) is a software program designed to aid the physician's decision-making process in the pre-hospital and Emergency Department setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (ACI). The HP ACI-TIPI software package enhances the computer-assisted ECG analysis capabilities of the HP PageWriter XLi and 300pi cardiographs. The program is called a Time- Insensiti ve Predictive Instrument because it uses information that is readily available both real-time in the Emergency Department can be used for retrospective review to aid in quality assurance. This tool has been shown in clinical studies to help improve detection of ACI. Features Can be manually selected or configured to automatically report the probability of acute cardiac ischemia on ECGs printed by the Page Writer XLi and 300pi cardiographs. Generation of the report is prompted by entry of three simple variables in the patient ID field: age, gender and severity of chest pain. Reports can be stored on the HP TraceMaster ECG Management System and the HP ECG Manager. An optional Risk Management Report can be printed which thoroughly documents the physician's decision-making process. Printing of the Risk Management Report can be triggered by user- configurable high and low ACI- TIPI probability score thresholds. HP ACI-TIPI The Hewlett-Packard Acute Cardiac Ischemia Time-Insensitive Predicti ve Instrument (HP ACI-TIPI) provides physicians with an additional tool in the diagnosis of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction). After answering a series of questions, the physician is presented with a numerical score, which is the predicted probability that the patient has ACI. The clinical features entered by the clinician include: patient age, gender, and whether chest or left arm pain is the chief Cardiography complaint, a secondary complaint, or not present. TIu-ee ECG features are examined which are taken from the computerized analysis of the electrocardiogram. They are: the presence or absence of abnormal Q wa ves, the presence and degree of ST segment elevation or depression, and the presence and degree of T-wave elevation or inversion. ECG features must be apparent in at least two related leads and must not be due to any exclusionary cases which can interfere with ECG interpretation (repolarization abnormalities secondary to L VH, RBBB, LBBB, artificial pacemaker or early repolarization). While none of the ECG features alone is sufficient for diagnosing ACI, together they represent the most important ECG features for predicting ACI. A vaiJable Reports The ACI-TIPI report prints a standard ECG trace, the ACI-TIPI score, plus detailed infonnation about how the ACI-TIPI probability was derived. An optional Risk Management Report can be printed which helps physicians document their decision- making processes. This report can be used to help focus attention on the process and procedures used to Ji:lgnose ACI in the :lcute care setti ng. The ACI-TIPI Report The ACI-TIPI report is meant to be used in place of the standard Auto ECG report in clinical settings where ACI is a major diagnostic concern. It is based on the standard Auto ECG report, but provides ACI-TIPI interpreti ve statements instead of the regular computerized ECG analysis statements. Just like the standard ECG report, the ACI-TIPI report provides ten seconds of ECG waveforms and standard waveform measurements. On the ACI- TIPI report, the predicted probability of ACI is accompanied by a list of the clinical variables and ECG features used by ACI- TIP!. At the end of the report is a coded listing of coefficients that were used in the HP ACI-TIPI formula. The Risk Management Report The HP ACI-TIPI report can include an optional Risk Management Report. This form may be configured to print on a separate page. It covers key clinical and ECG findings relevant to the triage decision-making process for ACI. These findings include characterization of the chest pain or chief complaint, its duration, factors which have made it worse or relieved it, comparison to prior ECGs, history of prior heart attack, prior nitroglycerin use, and the ultimate admit/discharge decision. By thoroughly documenting the Emergency Department examination, this report provides a useful tool for assessing and managing malpractice risk. Physicians may choose not to use the Risk Management Report, or to accommodate the institution's needs and triage protocols, the Risk Man:lgement Report can be set to print automatically at specified ACI- TIPI probabilities. Predictive Instruments Predicti ve instruments are appropriate for medical situations where clinical judgment is dependent upon a number of diagnostic variables. This sort of mathematically-based decision aid is useful in critical care situations where speed of diagnosis can be crucial. If it is a time-insensitive predictive instrument (TIPI) such as the ACI-TIPI, it can also be used retrospecti vely, to aid in quality assurance and cost control efforts. The HP ACI-TIPI report uses a logistic regression mathematical formula that, based on the patient's age, gender, chief complaint, and ECG, computes a predicted probability of ACI in the fonn of a percentage score. The HP ACI-TIPI algorithm and report are implementations of work by Harry P. Selker, M.D., and his colleagues at New England Medical Center. Dr. Selker is a clinician and researcher who has. worked for many years in hospitals and Emergency Departments, and directs a research center that studies ways to improve emergency care through decision aids. The development of the ACI-TIPI instrument resulted from Dr. Selker's recognition of the need to increase the Emergency Department (ED) physician's ability to quickly and correctly diagnose ACI. By analyzing the Emergency Department triage process, his research team was able to determine which factors led to the best decisions. These factors were incorporated into the formula. Extensive work on ACI- TIPI has been done in consultation with Dr. Selker to produce Hewlett- Packard's application of ACI-TIPI for the PageWriter XLi and 300pi cardiographs, and the HP CodeMaster 100 monitor- defibrillator with 12-Lead ECG. Physician Use Like any computer-assisted ECG interpretation program, HP ACI-TIPI evaluation is intended to supplement, not substitute for the physician's decision process. It is best used in conjunction with knowledge of the patient's history, the results of the physical examination, the ECG tracing, and other findings. The range of predicted probability of ACI produced by HP ACI-TIPI is expressed as a percentage from 0% to 100%. Specific ranges of predicted probability are not represented as indicating specific treatment decisions such as "admit to CClJ" or "send the patient borne", Specific ranges are meant to be utilized at the physician's discretion, and the meaning of any particular number or subset must be defined by the physician. Ordering Information Model M 1791 A Option CO 1 is compatible with PageWriter XLi cardiographs using version A.OS.OO or later operating software. It . includes application software on a 3-1/2" diskette (which is installed by the customer), User's Quick Reference Guide, and Predictive Instruments Physician's Guide. Orderable as the HP M3548A Predicti ve Instrument Upgrade. Model M 1791 A Option C02 is compatible with HP PageWriter 300pi cardiographs. It comes installed on the HP PageWriter 300pi and includes Quick Reference Guide and Predicti ve Instruments Physician's Guide. *The HP ACI-TIPI software program has been incorporated into the HP CodeMaster 100 monitor- defibrillator for use in pre-hospital emergency settings. HP ACI-TIPI is designed to aid physicians and paramedics in the pre-hospital environment. The ACI-TIPI report can be selected by the user, generated on the CodeMaster 100 monitor- defibrillator with 12-Lead ECG, transmitted to the hospital Emergency Department for physician overview, and stored on the HP TraceMaster ECG Management System and the HP ECG Manager receiving station. The CodeMaster 100 12-Lead ECG option includes ACI-TIPI and can be ordered as M2475B with option C90. For more information, please call your local HP sales office listed in your telephone directory or an HP regional office listed below for the location of your nearest sales office, Uniled Stales: Hew!eCt-POlcb.rd Comp:lllY Medical Products Group H~dqu:uters 3000 Miauceman ROOld Andover. MA OlSIO Medical Customer Information I-SOl}. 934-7372 Canada: Hewlett-POlcb.rd (C:llIOldOl) Lcd. 5150 Spectrum WOlY Mississ:!uga. Onurio lAW 5GI (905) 206-4725 Latin America: Hewlett-P:!cb.rd L:uia America. 5200 Blue L:igoon Drive 9th Floor MiOlmi. FI 33126 (305) 267-4220 Marketing Center Europe: Hewlett-POlcbrd Gmbh Schicbrdstr. 4 71OJ4 Boebliagen GerlTl:lllY Medical Distribution Distribution Europe. Middle E:lSt, Arnc:! (+41) 22 7S0 4111 Asia Pacific Headquarters: Hewlett-P:!cbrd Asia Pacific Ltd. 17-211F SheU Tower. Times Squ:l!e 1 Mathesoa Street, CaUseWOlY Bay Hong Koag (+S52) 25997777 The information contained in rhi.f document i.f suhject to change without notice. Hewlett-Packard 1998 Printed in USA 8/98 5966-0441 E