May 2003, Volume 32, Number 5

Evaluation

Defibrillator/
Monitor/Pacemakers

Also in This Issue

IPM Procedure
Infusion Devices

ECRI Problem Reporting System

Hazard Report
Imperfect Protection: Syringe Safety Mechanisms Can Fail
User Experience Network
ECG Filters Do Not Meet Specifications on Zoll M Series and M Series CCT
Defibrillator/Monitors

Talk to the Specialist

High-Energy versus Low-Energy External Biphasic Defibrillators

A NONPROFIT AGENCY
Health Devices Editorial and Scientific Policy
CHARTER AND GENERAL POLICY PUBLISHER LaVerne Shaw-Bailey, BA, MA
ECRI Robyn J. Silverman, BA
ECRI. ECRI (formerly known as the Emergency Care Research Institute) is a
nonprofit health services research agency established in 1955. Debbie Siru, MSc, Bsc
Founder and President Emeritus
Jennifer E. Sisk, MA
Peer review. The extensive technical studies reported in Health Devices are Joel J. Nobel, MD
conducted by ECRI’s staff. All our articles are intensively reviewed by engineer- Thomas E. Skorup, BS, MBA
ing and clinical professionals, both within and outside ECRI, before publication. President and CEO John J. Skreenock, BS, MBA
Impartiality. ECRI respects and is impartial toward all ethical medical device Jeffrey C. Lerner, PhD David L. Snyder, PhD
companies and practices. Neither ECRI nor any of its staff members has a di- Erin M. Sparnon, BSE
Chief Operating Officer and
rect or indirect financial interest in promoting the sale of any medical device. Executive Vice President J. Michael Stewart
ECRI employees do not undertake private consulting work for the medical de- Melanie Moyer Swan, BS, MPH
Anthony J. Montagnolo, MS
vice industry or own stock in medical device companies. We accept no royal- Karyn Tappe, MS
ties, gifts, finder’s fees, or commissions, nor does Health Devices accept Executive Vice President
advertising. ECRI prohibits manufacturers from using or referring to our product Jay Ticer
and General Counsel
ratings or reports, in whole or in part, in advertising or promotional materials. Stephen J. Tregear, PhD
Ronni P. Solomon, JD
Charles Turkelson, PhD
COMPARATIVE EVALUATIONS Vice Presidents Donielle Weinholtz, BA
Scope. Device Evaluations, unless otherwise noted, cover only the specific Mark E. Bruley, BS, Lamont Williams, BA
models discussed. We caution readers against applying the ratings to models Accident and Forensic Investigation
that we did not evaluate. If we do not include a currently marketed device in an EDITORIAL BOARD
Vivian H. Coates, MBA, Information
Evaluation, this does not necessarily mean that it is no longer available or imply Services and Technology Assessment Pierre D. Anhoury, MD
anything about its value, safety, or performance. Henry T. DiSalvo, Sales Partner, Deloitte & Touche,
Ratings. Our ratings system is explained in each Evaluation. We urge readers Neuilly-sur-Seine Cedex, France
G. Daniel Downing, BS, MBA, Finance
to review it closely and to read Evaluations in their entirety before making medical- A. John Camm, MD, FRCP
David W. Watson, BSc,
device-related decisions. European Operations Professor of Clinical Cardiology, St.
ECRI accountability. Neither ECRI nor the Health Devices System implies George’s Hospital Medical School,
any warranty, including a warranty of merchantability or fitness for a particular Health Devices Management London, UK
and Contributing Staff
purpose, or assumes liability for the safety, performance, or effectiveness of the John H. Eichhorn, MD
evaluated products. We invite manufacturers to discuss their products and to James P. Keller Jr., MSBE, Director Professor and Chairman, Department
review test data before publication. However, ECRI assumes responsibility for Harvey Kostinsky, MSEE, of Anesthesiology, University of
the final Evaluation of a device. Technical Director Mississippi Medical Center,
Restrictions on the use of As an impartial Christian Lavanchy, BSME, Jackson MS
evaluator of biomedical technology, ECRI does not endorse any specific brand Engineering Director
Seymour Furman, MD
or model of device. Reproducing excerpts from our product Evaluations in pro- Richard S. Diefes, MS, Department of Cardio-Thoracic
motional materials implies endorsement, contravenes ECRI policy, and may vio- Associate Director Surgery, Montefiore Medical Center,
late copyright law. Please report any instances of improper use of ECRI’s Kenneth B. Ross, BSBE, Problem Bronx NY; Professor of Medicine and
published materials directly to: Legal Department, ECRI. Reporting System Manager Surgery, Albert Einstein College of
Daniel C. Alt, BSME Medicine, Bronx NY
ECRI PROBLEM REPORTING SYSTEM
Louis M. Anzalone Jr., BS Robert R. Kirby, MD
Purpose. We encourage readers, healthcare providers, patients, and device
Arthur J. Augustine, BS, BMET Professor of Anesthesiology,
suppliers to report all medical-device-related incidents and deficiencies to us
Raylene M. Ballard, BA, MS, University of Florida College of
so that we can determine whether a report reflects a random failure or one that
MT(ASCP) Medicine, Gainesville FL
is likely to recur and cause harm. (Please refer to the ECRI Problem Reporting
System section in each issue of Health Devices for complete information.) Richard Chapell, PhD Harold Laufman, MD, PhD
W. Jack Davie, MEngSci Professor Emeritus of Surgery,
Hazard Reports and User Experience Network™ (UEN™) articles.
Albert Einstein College of Medicine,
A hazard is a possible source of peril, danger, or difficulty. We publish generic Robert Davies
Bronx NY
or unit-specific Hazard Reports when we have identified a fault or design fea- Alastair Deller, MSc, CEng, SRCS
ture that might, under certain circumstances, place patients or users at risk. In Jesse T. Littleton, MD
contrast, UEN articles describe problems that we believe are unlikely to pose a Albert L. de Richemond, MS, PE Emeritus Professor of Radiology,
significant hazard. Most UEN articles describe common or nuisance problems David L. Doggett, PhD University of South Alabama Medical
that can be corrected with an available modification or revised operating or Joseph J. Dougherty, BS School, Mobile AL
maintenance procedures. Jonathan A. Gaev, MSE Paul Maleson, Esq
Submitting a medical device problem report. Concerned parties can Lorna E. Govier, BSME Philadelphia PA
submit problem reports to us by letter, by using a copy of the Problem Report-
Bruce C. Hansel, PhD Stuart J. Meldrum, BSc, PhD, CEng,
ing Form included in the Health Devices binder (additional copies are available
Jeffrey B. Heyman, BSE FIPEMB
on request), or by completing the online form available on the Web at www.
Director of Medical Physics and
ecri.org/problemreport. We also accept reports submitted by facsimile trans- Cécile Hue, BS Bioengineering, Norfolk and Norwich
mission, as well as by telephone. Patrice A. Hughes, BA, BSME Health Care NHS Trust, Norwich, UK
Rohit Inamdar, MSc
Postmaster Robert Mosenkis, MSE, CCE
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Send address change to Health Devices, 5200 Butler Pike, Plymouth Meeting, Meeting PA
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Matthew J. Meitzner, BS, MS Malcolm G. Ridgway, PhD, CCE
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PUBLISHING STAFF
Robert W. Schluth, BA, Editorial Director,
Health Devices Group
Garrett J. Hayner, BA, Editor
Alison Landis Stone, BA, Associate Editor

Production May 2003

Courtney Bowman, AAS, Art Director Volume 32, Number 5
Deirdre E. Devlin, BA
Suzanne R. Gehris
Marlene P. Hartzell
Soon-Ae Jo, BA

Copyediting 176 Executive Summary

Jill Greshes, MA, MEd, Copyediting
Coordinator
Katy Mancini, BA
Evaluation
Ryan Moyer, BA 177 Defibrillator/Monitor/Pacemakers
Library. 178 Introduction
Purpose and Use
Communications.
Applications
178 Update Evaluation Protocol
Circulation.
181 Product Profiles
COPYRIGHT 2003 BY ECRI Welch Allyn PIC 50
All rights reserved. All rights are reserved Zoll M Series CCT
under international and Pan-American
copyright conventions. All material in ECRI Other Models:
publications is protected by copyright. GE Medical Systems CardioServ
Readers may not copy, resell, or quote this Medtronic Physio-Control Lifepak 12
material in promotional literature.
Philips HeartStart XL
Reproduction. Unless otherwise noted, 192 Zoll M Series
ECRI prohibits reproduction of Health Devices
Zoll PD 1200
by anyone, by any means, for any purpose
193 Zoll PD 1400
(including library use and interlibrary loan)
without prior written permission. However, 193 Cardiac Science Powerheart CRM (not evaluated)
Health Devices System and SELECTplus™ 193 Medtronic Physio-Control Lifepak 20 (not evaluated)
hospital members may reproduce Hazard 194 Conclusions
Reports and User Experience Network™
(UEN™) articles for internal distribution only, Ratings
unless otherwise noted. Purchasing Considerations
Reprints. ECRI does make reprints of
individual articles or complete publications
Supplementary Articles
available for educational purposes. Contact 185 Welch Allyn PIC 50 Software and Device Modifications
ECRI’s Communications Department —
+1 (610) 825-6000, ext. 5888 — for more 191 Supplier Information
information. 192 Off the Market
193 Response of Pacing to ECG Leads-Off: Differing Approaches
SUBSCRIPTION INFORMATION
Health Devices (ISSN 0046-7022) is 195 A Note on Standardization
published monthly by ECRI. Subscriptions to
Health Devices are available only through
membership in the Health Devices System or
IPM Procedure
SELECTplus. Single copies of Health Devices 197 Infusion Devices
are available: standard issue price — $275
($85 for members); prices may vary for
double issues or special issues.
ECRI Problem Reporting System
Membership benefits. Annual membership Hazard Report
includes Health Devices, Health Devices 203 Imperfect Protection: Syringe Safety Mechanisms Can Fail
Alerts, and other benefits. Contact ECRI’s
Communications Department — +1 (610) User Experience Network
825-6000, ext. 5888 — for more information. 206 ECG Filters Do Not Meet Specifications on Zoll M Series and
Health Devices System (2003). $3,695 M Series CCT Defibrillator/Monitors
(special rates available for shared services).
Additional subscriptions to Health Devices,
with membership, for use within the same Talk to the Specialist
institution and location and mailed with the
original subscription: $750 per volume year.
205 High-Energy versus Low-Energy External Biphasic Defibrillators
SELECTplus. Contact ECRI for pricing
information.
Executive
Summary
Featured in This Issue . . .
Defibrillator/Monitor/Pacemakers
This month, we present an updated Evaluation of
defibrillator/monitor/pacemakers — devices that can be
used to assess and monitor a patient’s ECG, as well as de-
liver a defibrillating shock to the heart. The study (which
starts on page 177) includes ECRI’s ratings of six units
and features new evaluations of two units, the Welch Allyn
PIC 50 and the Zoll M Series CCT. We rate the units sepa-
rately for in-hospital and prehospital applications, specifi-
cally: general crash-cart use, in-hospital transport use, and
emergency medical service (EMS) use.
Five of the models we tested — including the two
newly evaluated units — offer the capabilities needed and
the level of performance that we desire for all three appli-
cations. We rate these models Acceptable and consider
them to be a good choice for both hospitals and EMS pro-
viders. Refer to the Conclusions section on page 194 for a
list of the models that we recommend for consideration.
Overall Purchasing Guidance
ECRI recommends that hospitals purchase biphasic units
instead of monophasic ones because there is strong clinical
evidence that supports the superiority of the biphasic wave-
form. All five of the models we rate Acceptable are avail-
able in a biphasic waveform version.
For In-Hospital Applications
All the evaluated models that performed well for general
crash-cart use also performed well for in-hospital transport
use. Although we did note some differentiation among the
Acceptable models in four areas — pacing, alarms, human
factors, and monitoring capabilities — these differences are
generally small and thus unlikely to affect selection. User
preferences, cost, and standardization will probably be the
most important considerations during purchase.
For EMS Use
Portability and battery life are two key issues to consider
for this application. All the units we rate Acceptable for
EMS use performed at a satisfactory level in these areas.
We did note some minor advantages and disadvantages,
but the clinical impact of these differences will be small
under most circumstances. As a result, user preferences
will probably be a more important consideration. When
purchasing a unit, EMS providers should keep in mind
HEALTH DEVICES 32 (5), May 2003
that extra features can add weight, reduce operating time,
and increase complexity. All of these factors may affect
the usability of the unit.
Infusion Devices IPM Procedure
ECRI’s Health Devices Inspection and Preventive Mainte-
nance (IPM) System includes dozens of ready-to-use pro-
cedures for verifying equipment performance and safety.
From time to time, we’ve included new or revised proce-
dures from the IPM System in the pages of Health Devices.
In this issue, we provide our updated procedure covering
infusion devices. We’ve revised it to reflect our perspec-
tives on the U.S. Joint Commission on Accreditation of
Healthcare Organizations’ (JCAHO) National Patient
Safety Goals covering infusion devices and alarm systems.
ECRI’s procedure defines tasks that should be carried
out during a routine major inspection. It can be used for a
wide range of infusion devices, including general-purpose,
syringe, and patient-controlled analgesic (PCA) pumps.
You can find the procedure on page 197.
Problem Reports
This month’s Problem Reporting section, which starts on
page 203, includes a Hazard Report describing the failure
of protective syringe safety mechanisms. This report
illustrates why it’s important for staff to remain cognizant
of needlestick hazards, even when protective devices are
used. Another problem report describes a discrepancy be-
tween the specified and actual performance of the ECG fil-
ters on two Zoll defibrillators, the M Series and M Series
CCT. And a Talk to the Specialist article explains why the
different waveforms provided by different biphasic defib-
rillators should not be a factor when choosing a model. ◆
Correction
On page 17 of our January 2003 Guidance Article “A
Clinician’s Guide to Surgical Fires,” one of our recommen-
dations for minimizing oxidizer risks stated: “Question the
need for 100% O2 for open delivery to the face (for exam-
ple, when using a nasal cannula); if possible, use air or
±30% O2 for open delivery, consistent with patient needs.”
The “±” symbol is incorrect. The statement should read
“use air or £30% O2.” We regret the error. ◆
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Evaluation

Defibrillator/Monitor/Pacemakers

UMDNS information. Defibrillator/Pacemakers, External [17-882] ■

Defibrillators, External, Manual [11-134] ■ Defibrillators, External, Semi-
Automated [18-500] ■ Pacemakers, Cardiac, External, Noninvasive Electrodes
[16-516]

Summary. Defibrillator/monitors allow operators to assess and monitor a pa-

tient’s ECG and, when necessary, deliver a defibrillating shock to the heart.
When integral noninvasive pacing is added, the device is called a defibrillator/
monitor/pacemaker. In this Evaluation, we present our findings for two newly
evaluated models, the Welch Allyn PIC 50 and the Zoll M Series CCT, and we
summarize our findings for the previously evaluated models that are still on the
market. We rate the models for the following applications: general crash-cart use,
in-hospital transport use, and emergency medical service (EMS) use.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. HEALTH DEVICES 32 (5), May 2003
Evaluation
Introduction
Defibrillator/Monitor/Pacemakers
Purpose and Use
Defibrillator/monitors combine the functions of a defibril-
lator and an ECG monitor into a single unit. When integral
noninvasive pacing capability is added, either as a stan-
dard feature or as an option, the resulting device is referred
to as a defibrillator/monitor/pacemaker. (Although this
study often refers to these devices simply as defibrillator/
monitors, our discussion generally applies to units equipped
with pacing capability as well.)
Defibrillator/monitors allow users to assess and monitor
a patient’s ECG and, when necessary, to treat abnormal
heart rhythms using electrical energy. These models are
designed for use by personnel trained in advanced life sup-
port (ALS). However, most models available today can
also be equipped with automated external defibrillation
(AED), or advisory, capability, which extends the ability
of a manual defibrillator/monitor by allowing the unit to
decide if a shock needs to be administered. Personnel
trained in basic life support (BLS) can be trained to oper-
ate defibrillator/monitors in AED mode.*
In this study, we describe the results of our testing of
two new defibrillator/monitors, and we update our find-
ings for several previously evaluated models. Additional
details about this technology are available in our earlier
studies (see the February 2002, September 2000, February
1998, and May-June 1993 issues of Health Devices).
Applications
WITHIN THE HOSPITAL
A defibrillator/monitor may be used by ALS-trained per-
sonnel for the following applications:
■ General crash-cart use, in which the unit is typically
placed on a cart that can be wheeled to the patient’s
bedside when the need arises. Alternatively, because
* Note that we distinguish between manual defibrillator/monitors with
AED capability and stand-alone automated external defibrillators, or AEDs.
Unlike the manual defibrillator/monitors included in this study, AEDs are
intended for use primarily in an automated mode. AEDs are designed for
use by individuals with only BLS training or with no previous medical
training at all, for applications such as public access defibrillation (PAD)
and first-responder use. An updated Evaluation of stand-alone AEDs will
be presented in the next issue of Health Devices.
HEALTH DEVICES 32 (5), May 2003
recent models are more portable than earlier ones,
many of the models that now might be used for this ap-
plication can, if necessary, be taken off the cart and car-
ried to the bedside to speed transport to the patient.
Devices geared for this application would commonly be
used in critical care units (CCUs), as well as specialized
areas such as the operating room, emergency depart-
ment, and cardiac catheterization laboratory.
■ In-hospital transport use, such as when the patient
needs to be moved from one care area to another.
AED capability may be advantageous for these
applications.
OUTSIDE THE HOSPITAL: EMS USE
In the prehospital environment, a defibrillator/monitor
may be used by ALS-trained responders (i.e., paramedics)
who would be called to the scene of a medical emergency.
We refer to this as emergency medical service (EMS) use.
This application also encompasses some other out-of-
hospital uses, such as critical care transport. In addition,
some organizations may choose to train BLS-trained per-
sonnel on the use of defibrillator/monitors in AED mode.
However, if your organization is looking for a device geared
toward lay users or people with BLS training, a stand-alone
AED is probably a better choice. We will be presenting our
Evaluation of AEDs in the next issue of Health Devices.
Update Evaluation Protocol
We subjected the newly evaluated models — the Welch
Allyn PIC 50 and the Zoll M Series CCT — to the same
criteria and test methods used when evaluating the previ-
ously evaluated models. Below, we list the tests included
in our protocol, along with any modifications made since
our last update of this study, published in February 2002.
For brevity, we detail only those criteria that have been
added or revised since the previous evaluation. For an
inclusive list of our criteria and test methods for defibrillator/
monitor/pacemakers, refer to the listing for the May 2003
Health Devices on the members page of our Web site
(www.ecri.org). This information can also be compiled
from previous Evaluations of these technologies (February
2002, September 2000, and February 1998).
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Evaluation

DEFIBRILLATOR/MONITOR TESTS ■ ECG Electrode Contact-Quality Indicator

Defibrillator ■ ECG Cables and Leads
■ Available Energy Settings ■ Monitor Display and Recording
Revised criteria. Our previous criteria did not account ■ Automatic Documentation of a Resuscitation Attempt
for low-energy biphasic units. The revised criteria state: ■ Annotation on the Recorded Strip
— Conventional defibrillators should provide a selec- Alarms
tion of energy outputs, as follows:
■ Activation
Monophasic units designed for adult defibrillation
■ Alarm Limits
should have settings encompassing the range from
50 to 360 J (e.g., 50, 100, 200, 300, 360 J). ■ Disabling and Silencing
Generally, biphasic units designed for adult defib- ■ Protection against Inadvertent Change
rillation should have settings at least encompassing Batteries
the range from 50 to 200 J (e.g., 50, 100, 200 J). ■ Battery-Powered Operating Time
High-energy biphasic units designed for adult de-
■ Low-Battery Indicator
fibrillation may have settings as high as 360 J (e.g.,
50, 100, 200, 300, 360 J). ■ Effect of Battery Status on Line-Powered Performance
Comment. Note that energy requirements for bi- ■ Battery Charging
phasic defibrillators are not well established and will ■ Battery Maintenance
vary from model to model depending on waveform Human Factors Design
characteristics. Refer to the Talk to the Specialist ar-
ticle, “High-Energy versus Low-Energy External
■ General Ease of Use
Biphasic Defibrillators,” on page 205 of this issue ■ Portability
for more information. ■ Display
— Monophasic or biphasic units capable of internal or Optional Monitoring Capabilities
pediatric defibrillation or synchronized cardiover- ■ End-Tidal Carbon Dioxide (ETCO2)
sion should also include energy settings within the
range of 5 to 50 J (e.g., 5, 10, 20, 50 J).
■ Noninvasive Blood Pressure (NIBP)

— Monophasic or biphasic units used for neonatal

■ Pulse Oximetry (SpO2)
applications should have additional low-energy set- General Tests
tings within the range of 1 to 20 J (e.g., 2, 3, 5, 7, ■ Test Loads
10, 20 J). ■ Disposable Defibrillation and Multifunction Electrode
■ Charge Time to Maximum Energy Options
■ Internal Defibrillation ■ Quality of Construction and Serviceability
■ Synchronized Cardioversion ■ Service Manual
Deleted criterion. We deleted the criterion for synchro-
nized cardioversion of simulated ventricular tachy- AUTOMATED EXTERNAL
cardia (VT) waveforms. While it is still expected that DEFIBRILLATOR CAPABILITY
the devices properly mark and synchronize to the QRS Analysis and Shock Initiation
complex of real VT waveforms, testing simulated VT ■ Automatic Analysis
may not be an accurate gauge of clinical efficacy. ■ Check-Patient Indicators
■ Disarm Function ■ Time to Shock
■ Short- and Open-Circuit Discharge Charge/Discharge Sequence
■ Paddle Contact-Quality Indicator ■ Ease of Following the American Heart Association
ECG Monitor and Recorder (AHA) Protocol
■ Heart-Rate Monitoring ■ Indicators

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. HEALTH DEVICES 32 (5), May 2003
Evaluation
Electromagnetic Compatibility (EMC) Requirements
Pediatric Defibrillation in AED Mode
NONINVASIVE PACEMAKER TESTS
Pacemaker
■ Rate Range and Resolution
■ Amplitude Resolution
■ Demand Mode
■ Fixed-Rate Mode
■ Susceptibility to Undetected Stoppage
Revised criteria. We clarified the criteria for this test.
The criteria now state:
— If an ECG lead comes off and/or a suitable ECG sig-
nal is unavailable during demand pacing, the unit
should revert to fixed-rate pacing (if available). Ad-
ditionally, the unit should sound a persistent audible
alarm until the condition is corrected and demand
pacing is restarted (manually or automatically).
Health Devices Ratings System
RATINGS POLICY
Health Devices Evaluations rate products based on their clinical
and technical acceptability and desirability. Ratings are based on
standard commercial products. Suppliers often modify their prod-
ucts in response to our findings, sometimes before we publish
our Evaluations. If the modified product is not available in time for
us to verify the significance of the change, we may include a
statement of the supplier’s intentions. In future issues of Health
Devices, we may update the information provided for the evalu-
ated products and may revise our ratings.
We recommend that you use our ratings as a guide for se-
lecting the best products for your healthcare facility. Actual
purchasing decisions should be based on a thorough under-
standing of the article, as well as on your specific clinical
applications, users’ opinions, standardization policies, direct
experience with the supplier, and price.
RATINGS CATEGORIES
Preferred. The product meets all major performance and
safety criteria. It has no serious shortcomings and offers signif-
icant advantages over other alternatives.
Acceptable. The product meets all major performance and
safety criteria and has no serious shortcomings.
Not Recommended. The product does what it is intended
to do, but not at the desired level of performance, or it has
HEALTH DEVICES 32 (5), May 2003
— If pacing is inadvertently interrupted (including ter-
mination due to an ECG leads-off condition), the
unit should sound a distinct and persistent audible
alarm until the condition is corrected and pacing is
restarted or until the alarm is intentionally stopped.
— For alarms applicable to the above scenarios, a si-
lencing feature is preferred. However, if a sounding
alarm is silenced, the unit should automatically reac-
tivate audible alarms within a short time (e.g., 90
sec), or the unit should sound a momentary tone pe-
riodically to remind the operator of a continuing
alarm condition.
ECG Monitor and Recorder
■ Pacemaker Pulse (Pacing) Marker
■ Annotation
General Tests
■ Test Loads
■ Cables
■ Human Factors Design
significant disadvantages compared with other alternatives.
For example, it may be more difficult to use or clean, or it may
be less suitable for a specific application. A product that we
rate Not Recommended is safe to use and does not have to be
withdrawn from service. However, we recommend against
purchasing the product unless overriding considerations
warrant it.
Unacceptable. The product fails to meet significant criteria
for performance or poses significant safety risks. A healthcare
facility that does not own such a product should not purchase
it. If you have a product that we have rated Unacceptable, re-
view the disadvantages of continuing to use it, and plan to
replace it. If you decide to purchase or continue to use the
product, carefully document the basis for your actions.
CONDITIONAL RATINGS
Occasionally, our rating for a product depends on whether a
healthcare facility is willing and able to take corrective mea-
sures to overcome a basic performance or safety shortcoming.
Corrective measures range from special training (e.g., stress-
ing the importance of certain operating instructions) to order-
ing an upgrade or modifying a product. If the facility meets the
conditions stated, the product is rated in the category speci-
fied — that is, Preferred, Acceptable, or Not Recommended.
However, if the facility does not or cannot meet the conditions,
the product is Unacceptable.
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Evaluation

Product Profiles

Evaluated Models
and Product Descriptions
On the pages that follow, we present all relevant descrip-
tions, specifications, test results, and ratings for the newly
evaluated models in individual product profiles. In addi-
tion, we provide updated information for the previously
evaluated units that are still being sold (although two are
no longer being actively marketed) and describe other units
that are also on the market but that we haven’t evaluated.
■ Welch Allyn PIC 50 . . . . . . . . . . . . page 182
■ Zoll M Series CCT . . . . . . . . . . . . page 187
■ Previously evaluated models:
— GE Medical Systems CardioServ . . . page 191
— Medtronic Physio-Control Lifepak 12 . page 191
— Philips HeartStart XL . . . . . . . . . page 192
— Zoll M Series . . . . . . . . . . . . . . page 192
— Zoll PD 1200 . . . . . . . . . . . . . . page 193
— Zoll PD 1400 . . . . . . . . . . . . . . page 193
We also list two previously evaluated models that are
no longer being marketed; see the inset on page 192.
■ Also available:
— Cardiac Science Powerheart CRM . . . page 193
— Medtronic Physio-Control Lifepak 20 . page 193
For information about how the evaluated units compare
with one another, refer to the Conclusions section on page
194. Note that in future updates of this study, our ratings
and rankings may change as we learn new information or
evaluate additional units.
Good. The unit performs satisfactorily. In general, any ad-
vantages of the unit balance or outweigh any disadvantages.
Fair. The unit either does not perform satisfactorily or has
a noteworthy deficiency or limitation. However, the fail-
ure, deficiency, or limitation is not likely to (1) cause an
adverse clinical outcome, (2) significantly affect the over-
all performance of the unit, or (3) place an excessive bur-
den on those who purchase, use, or service the unit.
Poor. The unit does not perform satisfactorily, and its de-
ficiencies or limitations are likely to (1) adversely affect
the clinical outcome, (2) significantly affect the overall
performance of the unit, or (3) place an excessive burden
on those who purchase, use, or service the unit.
RATINGS RATIONALE
We rate the evaluated units separately for in-hospital and
prehospital applications. Specifically, we rate them for
three applications:
■ general crash-cart use,
■ in-hospital transport use, and
■ EMS use.
(Note that we have eliminated our previous rating category
“In-Hospital Use by Basic as well as Advanced Users.”)
Currency Exchange Rates
Prices listed in Health Devices are typically presented in
U.S. dollars. The exchange rates below can be used to
provide rough cost comparisons in a number of currencies.

About Our Results and Ratings Equivalent for $1 (U.S.) on May 21, 2003
Currency Rate* Currency Rate*
PRESENTATION OF RESULTS Australian Dollars 1.52 Malaysian Ringgit 3.80
Brazilian Real 3.00 New Zealand Dollars 1.71
In reporting our test results, we present only those findings
British Pounds 0.61 Saudi Arabian Riyal 3.74
that we determined to be significant. We do not discuss Canadian Dollars 1.35 Singapore Dollars 1.72
results for tests in which a unit simply met our criteria or Euro 0.85 South African Rand 7.73
did not have any remarkable features. However, we do Hong Kong Dollars 7.80 Turkish Lira 1,494,000.00
provide a table listing ECRI’s judgment of the unit’s per- Japanese Yen 117.23
formance for all tests according to the following scheme: *The exchange rates listed were obtained through online sources
on the date indicated. Because these rates are variable, the infor-
Excellent. The unit possesses a feature or performs at a mation in this table should be used for approximations only. Also,
readers should recognize that actual purchase prices in particular
level that would likely be considered favorable during the regions may vary from the prices used for this study.
selection process.

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. HEALTH DEVICES 32 (5), May 2003
Evaluation
Welch Allyn PIC 50
Formerly Medical Research Laboratories (MRL) PIC
Note: At the time of our testing, this unit was marketed by
Medical Research Laboratories (MRL) as the MRL PIC.
However, the supplier has since been acquired by Welch
Allyn Inc. The company name has been changed to MRL,
a Welch Allyn Company, and the model we evaluated is
now called the Welch Allyn PIC 50. All the information in
this study was gathered before the acquisition. As a result,
we occasionally refer to changes MRL made during the
evaluation process. Product and contact information is
current as of publication; however, this information may
change as a result of the acquisition.
Supplier. MRL, a Welch Allyn Co. [418671], Buffalo
Grove, Illinois (USA); +1 (800) 462-0777, +1 (847)
520-0300; www.mrlinc.com
Product availability
■ Markets: Worldwide
■ CE mark: Yes
■ Date introduced: 1997
Product Description
The Welch Allyn PIC 50 is a portable defibrillator/monitor
designed for in-hospital and prehospital use by ALS- and
BLS-trained responders. It can be operated as a manual
unit or in AED mode. The optional AED function includes
voice prompts and onscreen messages. This model can be
operated from battery power or from AC line power, as
well as from a 12 V vehicle adapter when used for pre-
hospital applications.
HEALTH DEVICES 32 (5), May 2003
The Bottom Line
We rate the Welch Allyn PIC 50 Acceptable for the
three applications considered. The unit is easy to
use, has good battery performance, and can be
equipped with an array of monitoring capabilities,
including ETCO2, IBP, NIBP, SpO2, and tempera-
ture. While we did note disadvantages pertaining to
pacing and human factors issues, overall the unit is
comparable to the other units we rate Acceptable. ◆
This unit is now manufactured with a biphasic defibril-
lation waveform (older units may employ a monophasic
waveform). ECRI prefers biphasic waveforms to mono-
phasic waveforms. For more information on biphasic
defibrillators, see the Guidance Article “External Biphasic
Defibrillation: Should You Catch the Wave?” in the June
2001 Health Devices.
The unit stores event documentation internally or on a
PCMCIA data card (optional) and provides data transfer to
a PC via the PCMCIA card, fax, or RS-232 data port. In
addition, the PIC 50 offers, or can be configured to offer,
the following capabilities:
■ Noninvasive pacing
■ Synchronized cardioversion
■ 3-, 5-, or 12-lead ECG analysis
■ Monitoring of ETCO2, invasive blood pressure (IBP; 2
channels), NIBP, SpO2 (pulse oximetry), and temperature
The model we tested was equipped with 12-lead ECG
analysis and all the features listed above.
CHARACTERISTICS
Defibrillator. Truncated exponential biphasic waveform:
External defibrillation energy settings of 2, 5, 7, 10, 20,
30, 50, 70, 100, 150, 200, 300, and 360 J; internal de-
fibrillation energy settings of 2, 3, 4, 5, 6, 7, 8, 9, 10, 20,
30, and 50 J
Monitor
■ Active matrix color TFT display — 16.5 cm (6.5 in)
diagonal
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.

■ Lead selections:
— With 3-lead cable: I, II, and III
— With 5-lead cable: I, II, III, aVR, aVL, aVF, and V
— With 12-lead cable: I, II, III, aVR, aVL, aVF, V1,
V2, V3, V4, V5, and V6
Pacemaker
■ Pacing rate: 30 to 180 ppm, 5 ppm increments for 30 to
100 ppm; 10 ppm increments for 100 to 180 ppm
■ Pacing output: 30 to 180 mA, 5 mA increments
■ Pulse width: 20 msec
Power
■ NiMH (recommended) or NiCd 12 V rechargeable
battery; can also be operated from AC line power when
equipped with the optional Integral Charger/Bustle
Pack, from the auxiliary cable of the Quick Charger
battery charger, or from a 12 V vehicle adapter
■ Supplier-specified battery-powered operating time:
— SuperPac NiMH: Up to 4 hr ECG monitoring or 110
full-energy discharges or 3 hr combined ECG, SpO 2,
and NIBP monitoring while pacing
— SmartPak Plus NiCd: Up to 2 hr ECG monitoring or
60 full-energy discharges or 1.5 hr combined ECG,
SpO2, and NIBP monitoring while pacing
■ Supplier-specified battery charge time:
— SuperPac NiMH: 9.5 hr in Quick Charger or through
Integral Charger/Bustle Pack; 3 hr in single-slot
charger
— SmartPak Plus NiCd: 4.5 hr in Quick Charger or
through Integral Charger/Bustle Pack; 1.5 hr in
single-slot charger
■ Recommended battery-replacement interval: 24
months, or if battery fails capacity test
Dimensions and weight
■ Display size: 16.5 cm (6.5 in) diagonal
■ Unit size (H ´ W ´ D): 13.5 ´ 31.8 ´ 33 cm (5.3 ´ 12.5
´ 13 in) without Integral Charger; 13.5 ´ 31.8 ´ 42.5 cm
(5.3 ´ 12.5 ´ 16.7 in) with Integral Charger
■ Weight: 8.0 kg (17.6 lb) with Integral Charger, paddles,
and battery
COST ISSUES
List prices:
■ 3-lead basic unit (includes SpO2): $12,500
■ 12-lead basic unit (includes SpO2): $16,800
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Evaluation
■ 3-lead deluxe unit (includes SpO2 and NIBP): $15,600
■ 12-lead deluxe unit (includes SpO2 and NIBP): $19,900
■ Options:
— ETCO2: $2,995
— External pacing: $1,000
— AED capability: $995
— Integral Charger/Bustle Pack: $1,100
— Quick Charger (3-bay): $1,600
— External paddles: $395
— SuperPac NiMH rechargeable battery: $250
— IBP (transducers sold separately): $1,495
— Disposable Tympanic Temperature Sensor (other ac-
cessories required): $195
Significant Test Results
We discuss the significant results of our testing below.
Judgments for each test performed are listed in the table
on page 184.
DEFIBRILLATOR/MONITOR TESTS
Defibrillator. Good — The unit performed well for all
tests in this category. Note, however, that we did not eval-
uate the PIC 50 for internal defibrillation because the
biphasic waveform version of this unit does not have U.S.
Food and Drug Administration (FDA) clearance for this
application. Nevertheless, ECRI sees no reason why this
unit would not be efficacious for this application.
ECG monitor and recorder. Good — The unit performed
well for most tests in this category. One advantage we
noted is that the unit does not have to be taken out of ser-
vice for data retrieval. Data can be transferred using a
PCMCIA card, fax, or data port. One disadvantage is that
the ECG strip-chart recorder does not automatically print a
waveform for every alarm condition. However, it does
print out a text message noting the alarm, and it properly
prints a waveform for each defibrillation attempt. Another
disadvantage we noted is that, during successive shocks, a
shock delivered during the strip-chart printout of the previ-
ous shock would occasionally disable the ECG printout for
that second (not yet printed) shock. However, the wave-
form data was still stored in the event log for later review
and printing. We also found playback of the voice recorder
difficult to hear in noisy environments.
Alarms. Good — We identified several disadvantages
during our initial testing of this unit, which was operating
with software Revision V2. However, the supplier made
HEALTH DEVICES 32 (5), May 2003
Evaluation

several changes in response to our findings and submitted

updated software (Revision X) for examination. The up- Test Results
graded unit performed well for all tests in this category. Welch Allyn
PIC 50
(See “Welch Allyn PIC 50 Software and Device Modifica-
DEFIBRILLATOR/MONITOR TESTS
tions” on page 185 for details.)
Defibrillator Good
Batteries. Good for both in-hospital and EMS applica- Available energy settings Good
tions.* The unit performed well for most tests in this cate- Charge time to maximum energy Good
Internal defibrillation Not tested*
gory. An advantage we noted was that the Quick Charger
Synchronized cardioversion Good
can charge three batteries simultaneously. Disarm function Good
Note that the PIC 50 met our EMS four-hour charge Short- and open-circuit discharge Good
Paddle contact-quality indicator Good
battery-powered operating time criterion after charging
ECG monitor and recorder
with only the single-slot charger. When we tested the PIC
Alarms
50 after charging with the Quick Charger for four hours,
Batteries Good
the unit delivered only 1 set of 10 shocks and approxi- Battery-powered operating time Good
mately 1.5 hours of monitoring before shutoff. Low-battery indicator Fair
Effect of battery status on line-powered
We did note a few disadvantages: The PIC 50 did not performance Good
meet our criteria for the low-battery indicator, delivering Battery charging Excellent
only 8 of the 10 desired shocks after the first activation of Battery maintenance Good
the indicator. We also found the indicator to be somewhat Human factors design Fair
General ease of use Fair
difficult to see. However, the indicator is accompanied by
Portability Good
an audible tone and a chart recorder message, as well as a Display Good
spoken message when in AED mode. Optional monitoring capabilities Good
The manufacturer states that charge time for the Inte- End-tidal carbon dioxide (ETCO 2) Good
Noninvasive blood pressure (NIBP) Good
gral Charger is the same as for the Quick Charger and, Pulse oximetry (SpO 2) Good
thus, performance after charging with either charger would General tests Good
be the same. Test loads Excellent
Disposable defibrillation and
Human factors design. Fair — A disadvantage is that multifunction electrode options Good
the SHOCK button for hands-free defibrillation is not lo- Quality of construction and serviceability Good
cated near the ENERGY SELECT and CHARGE buttons. In- Service manual Good

stead, it is located on the paddle connector cable on top of AUTOMATED EXTERNAL DEFIBRILLATOR CAPABILITY
the unit. Furthermore, the disarm button is placed where Analysis and shock initiation Excellent
the shock button would typically be expected. To test the Charge/discharge sequence Excellent
impact of these button placements, we had three users fa- EMC requirements Good
miliar with defibrillators — but unfamiliar with the partic- Pediatric defibrillation in AED mode Not tested*
ular unit — attempt to deliver a shock without instruction. NONINVASIVE PACEMAKER TESTS
(This scenario would be relevant to rotating clinicians and Pacemaker Fair
other situations in the hospital in which a person who has Rate range and resolution Good
Amplitude resolution Good
not been trained on this particular unit would need to treat
Demand mode Good
a patient.) All three users were unable to locate the SHOCK Fixed-rate mode Excellent
button, with one erroneously pressing the DISARM button. Susceptibility to undetected stoppage Fair

MRL has since developed a software upgrade and en- ECG monitor and recorder Good
Pacemaker pulse (pacing) marker Good
hanced labeling to better indicate the SHOCK button loca- Annotation Good
tion to unfamiliar users. Refer to the supplementary article General tests Good
on the next page for details. Repeating our test (employ- Test loads Excellent
ing different users) with the new modifications showed Cables Good
Human factors design Good

* The results of our battery testing pertain to use with the SuperPac * Supplier does not have FDA approval for this application.
high-capacity battery pack, which is the battery that the manufacturer rec-
ommends for use with this unit.

HEALTH DEVICES 32 (5), May 2003 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.

one of three users unable to locate the SHOCK button.
While still not ideal, the improvements better direct users
to the button, reducing the risk of delaying therapy. In ad-
dition, properly trained users should have no difficulty op-
erating the device.
Optional monitoring capabilities. Good — The ETCO2,
NIBP, and SpO2 options met most of our criteria. One dis-
advantage of the unit’s NIBP feature is that starting a man-
ual pressure measurement will restart the cycling clock.
This affects NIBP trending at preset intervals.
General tests. Good — The unit performed well for all
tests in this category. One advantage we noted is that the
unit has an integral test load to test the defibrillator if
equipped with the integral battery charger.
AUTOMATED EXTERNAL DEFIBRILLATOR
CAPABILITY
We considered the AED function of this unit to be excellent.
Analysis and shock initiation. Excellent — The unit
automatically analyzes and charges between individual
shocks in a set of three shocks. This eliminates the need
for the operator to remember to press the ANALYZE button
between shocks.
Welch Allyn PIC 50 Software and
Device Modifications
In response to a number of disadvantages we found dur-
ing initial testing of the Welch Allyn PIC 50, MRL —
the manufacturer of the product at that time — made
several changes. MRL modified the original software
(Revision V2) during the course of our evaluation and
submitted the updated software (Revision X) to ECRI.
We were able to verify that the modifications eliminated
some stated disadvantages and alleviated others.
Below, we list our initial findings and then provide an
update on any software/product changes that MRL made.
We adjusted our ratings and revised the information in
the product profile as appropriate to reflect the changes.
Alarms
■ Initial finding. On startup, the unit retained previous
alarm-limit values instead of defaulting to preset
alarm limits.
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Evaluation
Charge/discharge sequence. Excellent — This unit
makes it easy for operators to follow the AHA protocol for
AED use (i.e., a set of three shocks, followed by one min-
ute of cardiopulmonary resuscitation [CPR], followed by a
set of three shocks).
Electromagnetic compatibility (EMC) requirements.
Good — This unit meets our criterion. The supplier states
that it tested the unit according to IEC 60601-1-2/EN
60601-1-2 and found that the unit functioned normally
when subjected to fields of 10 V/m.
Pediatric defibrillation in AED mode. Not tested —
This unit is not cleared by FDA for pediatric defibrillation
in AED mode.
NONINVASIVE PACEMAKER TESTS
We judged the unit’s pacemaker function to be fair over-
all. The unit satisfied many of our criteria and even had
one noteworthy advantage, in that it offers a Fixed-Rate
mode. However, the unit discontinues pacing when a suit-
able ECG signal becomes unavailable (i.e., due to leads-
off) while in Demand or Fixed-Rate mode. We consider
this a significant disadvantage. Refer to “Response of
Update. The unit is now supervisor-configurable to
allow either alarm-limit retention or reversion to de-
fault levels on power-up.
■ Initial finding. If automatic heart rate alarm limits
were used and the unit was then powered off, no
alarm limits would be set when the unit was turned
back on. The problem was that, instead of being rep-
resented by the “crossed-out bell” icon that generally
denotes a disabled alarm, this state was represented
by a different icon. As a result, it may have been un-
clear to users that heart rate alarms would not sound
in this state.
Update. Under the above circumstances, the unit
now defaults to a disabled-alarm state; this state is
indicated by the “crossed-out bell” icon.
(continued on page 186)
HEALTH DEVICES 32 (5), May 2003
Evaluation
Pacing to ECG Leads-Off” on page 193 and the Conclu-
sions section for further discussion.
Summary of Findings
Refer to the Conclusions section for information about
how this unit compares with other units evaluated by
ECRI.
IN-HOSPITAL APPLICATIONS
The PIC 50 is a good choice for the hospital environment.
The unit is easy to use, and it includes all the features
needed for in-hospital applications. However, we did note
disadvantages relating to pacing and human factors design.
Application-specific ratings and relevant findings are
listed below.
General crash-cart use. We rate the PIC 50 Acceptable
for general crash-cart use when equipped with the Integral
Charger, which allows operation from AC power when
needed. In addition to being easy to use, the unit can be
equipped with optional advisory (AED) capability. The
unit also showed good battery performance.
(continued from page 185)
■ Initial finding. High and low alarm limits could
overlap, so that the unit could have been in a con-
stant state of alarm.
Update. This possibility has been eliminated.
Human Factors Design
■ Initial finding. The DISCHARGE button for hands-
free defibrillation is not located near the ENERGY
SELECT and CHARGE buttons, which is where the
DISCHARGE button is located on most defibrillators.
Instead, it is located on the paddle connector cable
on top of the unit. Additionally, the DISARM button is
located where a user would intuitively expect the
DISCHARGE button to be. If the user erroneously
presses DISARM instead of DISCHARGE, a message on
the strip-chart recorder is the only indication that no
shock was delivered.
Update. This disadvantage still exists. However,
MRL made software and device-labeling changes to
aid button recognition. With the new software revi-
sion, disarming the device causes “DEFIB DISARM” to
HEALTH DEVICES 32 (5), May 2003
In-hospital transport use. We rate the PIC 50 Accept-
able for in-hospital transport use. In addition to being easy
to use, the unit can be operated using AC line power when
equipped with the Integral Charger and can be equipped
with an array of optional monitoring capabilities, includ-
ing ETCO2, IBP, NIBP, SpO2, and temperature. With the
new software revision, the unit also passes all our alarm
criteria.
EMS USE
The PIC 50 performs similarly to the other evaluated
models for EMS use and, like most of those models, is
rated Acceptable for this application. This unit is light-
weight, compact, and easy to use. In addition, it can be
equipped with 12-lead ECG monitoring capability. The
unit can also be purchased without the integral battery
charger to reduce size and weight and, if necessary, can be
externally powered through a DC vehicle power adapter or
through the auxiliary DC line from the stand-alone Quick
Charger. Note that the PIC 50 met our EMS four-hour
charge battery-powered operating time criterion with only
the single-slot charger.
flash in the energy window for 10 sec. With a hands-
free defibrillation cable connected, an icon indicat-
ing the DISCHARGE button location appears in the
energy window while the unit is charged or charg-
ing. A label on the hands-free adapter now identifies
the DISCHARGE button with the number “3.”
Noninvasive Pacemaker
■ Initial finding. The unit stops pacing when it loses a
suitable ECG signal (such as during an ECG leads-
off condition) while in Demand or Fixed-Rate mode.
Furthermore, when a leads-off condition is cor-
rected, the audible leads-off alarm stops sounding,
and no alarm warns that pacing remains disabled.
Update. MRL addressed these problems to some
extent by revising the software. MRL added indica-
tors to aid clinician awareness that pacing has been
stopped. As with the previous software version, an
alarm sounds during a leads-off condition. Now,
however, after the lead is reapplied, the unit flashes
“RESTART PACER” in the pacing window until pacing
is restarted by a clinician. This message is accompa-
nied by a distinct audible alarm. ◆
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.

Zoll M Series CCT
Supplier. Zoll Medical Corp. [150032], Burlington,
Massachusetts (USA); +1 (800) 348-9011, +1 (781)
229-0020; www.zoll.com
Product availability
■ Markets: Worldwide
■ CE mark: Yes
■ Date introduced: 2002
Product Description
The Zoll M Series CCT is a portable defibrillator/monitor
specifically designed for in-hospital transport use by
ALS-trained responders. However, its features and config-
uration options allow use for general crash-cart and EMS
applications as well. It can be operated as a manual unit, or
it can be configured with an advisory capability that pro-
vides AED functionality. This unit can be operated either
from battery power or from line power.
This unit uses a biphasic defibrillation waveform. ECRI
prefers biphasic waveforms to monophasic waveforms. For
more information on biphasic defibrillators, see the Guid-
ance Article “External Biphasic Defibrillation: Should
You Catch the Wave?” in the June 2001 Health Devices.
This unit provides event documentation and data trans-
fer via a PCMCIA card. The M Series CCT is essentially
an M Series unit, which we evaluated in September 2000
(see page 318 of that issue), with additional features and
display capabilities. Like the M Series, the CCT model of-
fers, or can be configured to offer:
■ Noninvasive pacing
■ Synchronized cardioversion
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Evaluation
The Bottom Line
We rate the Zoll M Series CCT Acceptable for the
three applications considered. The unit is designed
specifically for in-hospital transport; however, it can
be configured without many of the optional monitor-
ing capabilities, making it suitable for general
crash-cart use as well. Although the unit is suitable
for EMS use overall, the battery performance was
below that of some other Acceptable units for this
application. Generally, the unit is easy to use and
can be equipped with many advantageous features
for in-hospital transport applications, including
ETCO2, IBP, NIBP, SpO2, and temperature. ◆
■ 3-, 5-, or 12-lead ECG analysis
■ Monitoring of ETCO2 and SpO2 (pulse oximetry)
In addition, the CCT offers the following features and
capabilities:
■ A 16.5 cm (6.5 in) color display
■ The ability to display three traces simultaneously
■ A choice of which traces to display in addition to ECG
■ Connection to an external VGA display
■ Configuration of displayed parameters by color
■ Monitoring of IBP, NIBP, and temperature
The model we tested was equipped with 3-lead ECG
and all the features and capabilities listed above except
ETCO2.
CHARACTERISTICS
Defibrillator. Rectilinear biphasic waveform: Energy set-
tings of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 75, 100,
120, 150, and 200 J
Monitor
■ Active matrix color LCD — 16.5 cm (6.5 in) diagonal
■ Lead selections:
— With 3-lead cable: I, II, and III
— With 5-lead cable: I, II, III, aVR, aVL, and aVF or
V; all are acquired simultaneously
HEALTH DEVICES 32 (5), May 2003
Evaluation
— With 12-lead cable: I, II, III, aVR, aVL, aVF, V1,
V2, V3, V4, V5, and V6
Pacemaker
■ Pacing rate: 30 to 180 ppm, 2 ppm increments
■ Pacing output: 0 to 140 mA, 2 mA increments
■ Pulse width: 40 msec
Power
■ SLA battery (12 V rechargeable); can be operated from
AC line power or DC vehicle adapter
■ Supplier-specified battery-powered operating time:
40 defibrillator discharges at 200 J, or 2.5 hr minimum
continuous ECG and SpO2 monitoring, or 1.5 hr con-
tinuous ECG, ETCO2, IBP, SpO2, and temperature
monitoring/pacing at 60 mA, 70 bpm
■ Supplier-specified battery charge time: 7.2 hr or less
with integral charger
■ Recommended battery-replacement interval: 18 months,
or if battery fails capacity test
Dimensions and weight
■ Display size: 16.5 cm (6.5 in) diagonal
■ Unit size (H ´ W ´ D): 21.8 ´ 25.9 ´ 22.4 cm (8.6 ´
10.2 ´ 8.8 in) without IBP, NIBP, and temperature;
25.9 ´ 26.2 ´ 22.1 cm (10.2 ´ 10.3 ´ 8.7 in) with IBP,
NIBP, and temperature
■ Supplier-specified weight: 7.8 kg (17.2 lb) with
multifunction cable and battery; 8.7 kg (19.1 lb) with
multifunction cable, battery, and paddles
COST ISSUES
List prices:
■ Base unit (SpO2 standard) without pacemaker: $12,885
■ Base unit with SpO2 and NIBP: $15,885
■ Base unit with SpO2 and ETCO2: $17,685
■ Base unit with SpO2, NIBP, and IBP/temperature: $17,880
■ Base unit with SpO2, NIBP, and ETCO2: $20,685
■ Base unit with SpO2, NIBP, ETCO2, and IBP/tempera-
ture: $22,680
■ Options:
— Pacemaker: $2,000
— 12-lead ECG: $7,395
HEALTH DEVICES 32 (5), May 2003
Significant Test Results
We discuss the significant results of our testing below.
Judgments for each test performed are listed in the table
on page 189.
DEFIBRILLATOR/MONITOR TESTS
Defibrillator. Good — The unit performed well for most
tests in this category. However, we judged it only fair for
our Disarm Function test because the unit doesn’t have an
onscreen message or a labeled control for disarming the
unit. The user must manually switch the selector from
the Defibrillator position to either the Monitor position or
the Off position to disarm the unit.
We did not evaluate the unit for internal defibrillation
because it has not received FDA clearance for this applica-
tion. Nevertheless, ECRI sees no reason why this unit
would not be efficacious for this application.
ECG monitor and recorder. Good — The unit performed
well for all tests in this category. One advantage we noted is
that the unit doesn’t have to be taken out of service for data
retrieval. Data can be transferred using a PCMCIA card.
Alarms. Good — The unit performed well for all tests in
this category.
Batteries
■ For in-hospital applications: Good
■ For EMS applications: Fair — With a fully charged
battery, the unit could not perform the full resuscitation
sequence we require for out-of-hospital use (i.e., 10
shocks and 5 minutes of strip-chart recording, followed
by 2 hours of monitoring, then another 10 shocks and
5 minutes of recording). For the second set of shocks,
the unit was able to deliver only 0 (worst case) to 5
(best case) of the 10 consecutive shocks required.
One advantage we noted for both applications is that
the separate charger can charge four batteries at a time.
Human factors design. Good — The unit is portable,
easy to use, and has clearly labeled controls. We did, how-
ever, note a few disadvantages. First, the unit doesn’t
clearly indicate that it is in Manual mode. Second, the
same button is used to both silence and deactivate alarms;
pushing the button silences the alarm, while keeping the
button depressed for an additional three seconds deacti-
vates the alarm. Finally, the AC power cord can be easily
disconnected, resulting in a lack of power to the unit for
operation or battery charging. (Zoll does offer a retention
clip that prevents this type of disconnection; we recom-
mend that this clip be used on units that will be operated
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Evaluation

or charged on line power. For perspectives on this issue, Test Results

refer to the Hazard Report “Reducing the Risk of Power Zoll M
Series CCT
Loss to Critical Equipment” in the April-May 1998 Health
DEFIBRILLATOR/MONITOR TESTS
Devices.)
Defibrillator Good
Optional monitoring capabilities. Good — The SpO2 Available energy settings Good
and NIBP options met our criteria. The unit we tested was Charge time to maximum energy Good
Internal defibrillation Not tested*
not equipped with ETCO2; therefore, we cannot report
Synchronized cardioversion Good
findings on this option. Disarm function Fair
General tests. Good — The unit performed well for all Short- and open-circuit discharge Good
Paddle contact-quality indicator Good
tests in this category. One advantage we noted is that the
ECG monitor and recorder Good
unit has an integral test load to test the defibrillator.
Alarms Good
Batteries Good/Fair**
AUTOMATED EXTERNAL DEFIBRILLATOR
Battery-powered operating time Good/Fair**
CAPABILITY Low-battery indicator Good
We considered the advisory function of this unit to be Effect of battery status on line-powered
performance Good
excellent. Battery charging Excellent
Analysis and shock initiation. Excellent — If properly Battery maintenance Good
configured, the unit automatically analyzes and charges Human factors design Good
General ease of use Good
between individual shocks in a set of three shocks. This
Portability Good
eliminates the need for the operator to remember to press Display Good
the ANALYZE button between shocks. (Note that the Optional monitoring capabilities Good
ANALYZE button must be pressed initially to start the End-tidal carbon dioxide (ETCO 2) Not tested***
sequence.) Noninvasive blood pressure (NIBP) Good
Pulse oximetry (SpO 2) Good
Charge/discharge sequence. Excellent — This unit General tests Good
makes it easy for operators to follow the AHA protocol for Test loads Excellent
AED use (i.e., a set of three shocks, followed by one min- Disposable defibrillation and
multifunction electrode options Good
ute of cardiopulmonary resuscitation [CPR], followed by a Quality of construction and serviceability Good
set of three shocks). Service manual Good

Electromagnetic compatibility (EMC) requirements. AUTOMATED EXTERNAL DEFIBRILLATOR CAPABILITY

Good — This unit meets our criterion. The supplier states Analysis and shock initiation Excellent

that it tested the unit according to IEC 60601-1-2 and Charge/discharge sequence Excellent

found that the unit functioned normally when subjected to EMC requirements Good

fields of 10 V/m. Pediatric defibrillation in AED mode Not tested*

Pediatric defibrillation in AED mode. Not tested — NONINVASIVE PACEMAKER TESTS

This unit is not cleared by FDA for pediatric defibrillation Pacemaker Good
Rate range and resolution Good
in AED mode. Amplitude resolution Good
Demand mode Good
NONINVASIVE PACEMAKER TESTS Fixed-rate mode Excellent
Susceptibility to undetected stoppage Good
The unit performed well in almost all noninvasive pace-
ECG monitor and recorder Good
maker tests, leading us to judge its pacemaker function to
Pacemaker pulse (pacing) marker Good
be good overall. One advantage we noted is that the de- Annotation Fair
tected QRS complexes are marked during pacing. Another General tests Good
advantage is that a Fixed-Rate mode is available. Test loads Excellent
Cables Good
However, we also noted some disadvantages: (1) The Human factors design Good
unit does not revert to Fixed-Rate mode during an ECG * Supplier does not have FDA approval for this application.
leads-off condition. The unit will continue to pace the pa- ** Good for in-hospital applications; Fair for EMS applications.
*** The unit we tested did not have this feature.
tient in Demand mode, treating the leads-off condition as
asystole. While this method is preferable to discontinuing

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. HEALTH DEVICES 32 (5), May 2003
Evaluation
pacing altogether, ECG noise — such as that created when
the reference lead is detached — can inhibit pacing beats
in Demand mode. (Refer to “Response of Pacing to ECG
Leads-Off” on page 193 and the Conclusions section for
further discussion.) (2) The unit does not indicate when it
is in Demand mode, and the recorded strip does not
indicate that the unit is in Pacing mode.
Summary of Findings
Refer to the Conclusions section for information about how
this unit compares with other units evaluated by ECRI.
IN-HOSPITAL APPLICATIONS
Although it is designed specifically for in-hospital transport
use, the Zoll M Series CCT is also suitable for other appli-
cations inside the hospital. When purchased without IBP,
NIBP, and temperature, the unit has all the capabilities of its
counterpart, the M Series, with the addition of a larger,
color screen and multiple-waveform display capability.
Hospitals must determine if these additional features justify
the additional cost of the CCT over the base M Series.
Coming Up
ECRI’s Latest Evaluation of AEDs
The June issue of Health Devices will feature an up-
dated Evaluation of stand-alone automated external
defibrillators (AEDs). Unlike the defibrillator/monitors
included in the accompanying study, AEDs are de-
signed specifically for applications such as public ac-
cess defibrillation (PAD) and first-responder use. In the
upcoming issue, we evaluate two of these units, and we
describe several additional currently available models.
We also include a Guidance Article that addresses fac-
tors for hospitals to consider when implementing an
AED program. Topics covered include training, use,
and liability.
HEALTH DEVICES 32 (5), May 2003
General crash-cart use. We rate the M Series CCT
Acceptable for general crash-cart use. The unit can be op-
erated from AC line power and has advisory capability. In
addition, the unit showed good in-hospital battery perfor-
mance, despite the additional monitoring capabilities.
In-hospital transport use. We rate the M Series CCT
Acceptable for in-hospital transport use. In addition to be-
ing easy to use, the unit offers the following advantages
for this application: It is lightweight, offers good battery
performance, can be operated from AC line power, and
offers ETCO2, IBP, NIBP, SpO2, and temperature
capabilities.
EMS USE
We rate the M Series CCT Acceptable for EMS use. The
unit’s primary disadvantage for this application is that bat-
tery performance is only fair. An advantage is that the unit
is compact and easy to use. In addition, it can be pur-
chased without many of the optional monitoring capabili-
ties to reduce size and weight and, if necessary, can be
externally powered through a DC vehicle power adapter.
ECRI is also working on the following articles for
inclusion in the next several issues:
■ A Guidance Article about how to protect yourself
while maintaining equipment that has been exposed
to the SARS virus. (Look for this article in June.)
■ An Evaluation of portable ultrasound units that will
help you determine which model is best for certain
areas in your facility.
■ A Guidance Article on newborn hearing screening
that will compare the available technologies and
help you select a system. ◆
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.

Previously Evaluated Models
In the past decade, ECRI has evaluated defibrillator/
monitors in five issues of the journal: May-June 1993,
February 1998, September 2000, February 2002, and the
current issue. We detail our findings for two newly evalu-
ated models in the product profiles that precede this sec-
tion. Below, we present updated information, including
revised ratings where applicable, for all previously evalu-
ated models that are still on the market. As part of our
evaluation update process, we investigate product changes
and review previous evaluation findings — and modify
them when necessary — to ensure that the information
provided in the update accurately reflects the current state
of the technology. In some cases, this review will lead us
Supplier Information
Cardiac Science Inc. [344498], Irvine, California
(USA); +1 (888) 274-3342, +1 (949) 797-3800;
www.cardiacscience.com
GE Medical Systems Information Technologies,
Cardiology Division [393585], Milwaukee, Wiscon-
sin (USA); +1 (800) 643-6439, +1 (414) 355-5000;
www.gemedicalsystems.com
Medical Research Laboratories (MRL) —
MRL, a Welch Allyn Co.
Medtronic Physio-Control Corp. [363222],
Redmond, Washington (USA); +1 (800) 442-1142,
+1 (425) 867-4000; www.medtronicphysio-control.
com
MRL, a Welch Allyn Co. [418671], Buffalo Grove,
Illinois (USA); +1 (800) 462-0777, +1 (847) 520-
0300; www.mrlinc.com
Philips Medical Systems, Cardiac and Monitoring
Systems Division [397917], Andover, Massachusetts
(USA); +1 (800) 934-7372, +1 (978) 687-1501;
www.medical.philips.com
Welch Allyn — See MRL, a Welch Allyn Co.
Zoll Medical Corp. [150032], Burlington, Massa-
chusetts (USA); +1 (800) 348-9011, +1 (781)
229-0020; www.zoll.com ◆
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Evaluation
Other Models
to change a unit’s rating based on product modifications,
changes made to our evaluation protocol, or the availa-
bility of additional models since the unit was originally
evaluated. Below, we describe any such changes to our
findings. Except where noted, we have not verified the
effectiveness of the product changes described.
Note that any ratings presented here supersede those
from our earlier studies. For information about how the ac-
tively marketed units compare to one another, refer to the
Conclusions section that follows. For additional informa-
tion about specific models, refer to the appropriate issue(s)
of Health Devices.
Units are listed in alphabetical order. For supplier con-
tact information, refer to the inset on this page.
GE Medical Systems
CardioServ
This unit is currently being
sold in Asia and Europe only.
Evaluation date. February
1998 (page 60), with update
information presented in
September 2000 (page 313)
and February 2002 (page 55). At the time of our original
Evaluation, this model was marketed by Marquette
Hellige; the product was later marketed by GE Marquette
See Medical Systems.
List prices. The supplier did not respond to repeated re-
quests for current pricing information.
Findings. We rate this model Not Recommended for all
the applications considered.
Medtronic Physio-Control
Lifepak 12
Evaluation date. September
2000 (page 314), with up-
date information presented
in February 2002 (page 56).
List prices
■ With monophasic wave-
form: $8,395
■ With biphasic waveform:
$9,865
HEALTH DEVICES 32 (5), May 2003
Evaluation

■ Options Update information. Philips has made a number of minor

— Electroluminescent display: $550 software and accessory changes; none of these changes
has had any effect on our findings or ratings of the unit.
— Noninvasive pacing: $1,575
Some changes include the following: An attachable acces-
— SpO2: $1,313 sory pouch is now available for holding items such as ca-
— 12-lead ECG: $7,613 bles, pads, and ECG electrodes. Also, external paddles
— NIBP: $2,888 have been unbundled from the purchasing package and
may now be purchased as an option.
— ETCO2: $3,995
Update information. The biphasic waveform version of Philips also reports that it has received FDA clear-
this product has received FDA clearance for internal ance to market this biphasic waveform unit for internal
defibrillation. defibrillation.
Findings. We rate this model Acceptable for all the appli- Findings. At the time of our original study, we did not cite
cations considered. In our previous studies, we rated this the following disadvantage: When pacing in Demand
unit (and a few others) Preferred for general crash-cart mode, the unit does not continue to pace the patient when
use. However, other models that offer comparable func- a suitable ECG signal becomes unavailable. Additionally,
tionality and features have since been introduced. Because silencing the alarm that sounds during this condition per-
none of these models stand out above the others, we now manently defeats it. (For more information on this issue,
rate them all Acceptable. refer to the supplementary article on page 193, as well as
the Conclusions section.) As a result of this disadvantage,
Philips HeartStart XL we now rate the unit’s overall pacemaker function fair in-
Evaluation date. February stead of good. This finding does not alter our overall rating
2002 (page 51). We for the unit.
evaluated this unit under
its former name, the We rate this model Acceptable for all the applications
Heartstream XL. considered. In our previous studies, we rated this unit (and
a few others) Preferred for general crash-cart use. How-
List prices
ever, other models that offer comparable functionality and
■ Base unit (AED mode is features have since been introduced. Because none of
standard): $7,995 these models stand out above the others, we now rate them
■ With SpO2: $9,245 all Acceptable.
■ With pacing: $10,345

Zoll M Series
Evaluation date. September
Off the Market
2000 (page 318), with up-
date information presented
The following models have been taken off the mar- in February 2002 (page 56)
ket since our last evaluation: List prices
Medtronic Physio-Control Lifepak 9P. Evaluated ■ Without pacemaker:
in May-June 1993; updated in February 1998, Sep- $8,890
tember 2000, and February 2002. The unit was mar-
■ With pacemaker: $11,390
keted by Physio-Control at the time of our original
study. Findings. We rate this model Acceptable for all the appli-
Medtronic Physio-Control Lifepak 10. Evaluated cations considered. In our previous studies, we rated this
in May-June 1993; updated in February 1998, Sep- unit (and a few others) Preferred for general crash-cart
tember 2000, and February 2002. The unit was mar- use. However, other models that offer comparable func-
keted by Physio-Control at the time of our original tionality and features have since been introduced. Because
study. ◆ none of these models stand out above the others, we now
rate them all Acceptable.

HEALTH DEVICES 32 (5), May 2003 ©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Evaluation

Zoll PD 1400
Response of Pacing to Evaluation date. May-June 1993, with update information
ECG Leads-Off presented in February 1998 (page 54), September 2000
Differing Approaches (page 313), and February 2002 (page 57)
Update information. This model is available from the sup-
plier; however, it is no longer being actively marketed. For
The evaluated units are divided in their approach to this reason, we no longer recommend it for purchase
handling ECG leads-off during demand pacing. (although the unit performed satisfactorily in our earlier
Some units continue pacing when an ECG lead is studies). An exception would be if your organization
detached by either reverting to Fixed-Rate mode or wanted to supplement an already existing inventory.
by remaining in Demand mode and pacing the pa-
tient as if he or she were asystolic. In either case, de-
mand pacing is automatically resumed when the lead Also Available
is replaced. Other units discontinue pacing during The following defibrillator/monitors are also on the mar-
leads-off and require a clinician to restart pacing ket, but ECRI has not evaluated the units. The descriptions
when the condition is resolved. are based on information from the supplier. We have not
tested these units and have not verified their performance
ECRI believes that the latter scenario places pa-
or any other claims made by the supplier.
tients at risk. External pacing is used on very critical
patients whose native pulse rate may not provide for Cardiac Science Powerheart CRM
sufficient circulation. It is often used temporarily until
Description. The Power-
an internal pacing lead can be inserted. Terminating
heart CRM (Cardiac
pacing during an ECG leads-off condition removes
Rhythm Module) is a bed-
this much-needed therapy and can compromise
side unit that can serve as
blood circulation. An alarm will sound due to the
a manual defibrillator or as
leads-off condition; however, if a clinician does not
a semiautomated or fully
respond promptly, the patient will not be paced for
automated AED.
that period of time and could be harmed as a result.
Therefore, our criteria require continuation of pacing List price. $6,500
during ECG interruption. Refer to the Conclusions
section for a model-specific discussion of external
pacing. ◆
Medtronic Physio-Control Lifepak 20
Description. The Lifepak 20
Zoll PD 1200 is a portable defibrillator/
monitor designed for in-
Evaluation date. May-June 1993, with update information hospital general crash-cart
presented in February 1998 (page 54), September 2000 and transport use by
(page 313), and February 2002 (page 57) ALS- and BLS-trained
Update information. This model is available from the sup- responders.
plier; however, it is no longer being actively marketed. We List prices. $8,285; with
do not recommend this unit for purchase. pacing and SpO2: $11,785

©2003 ECRI. Duplication of this page by any means for any purpose is prohibited. HEALTH DEVICES 32 (5), May 2003
Evaluation
Conclusions
In this section, we discuss factors to consider when select-
ing from among the evaluated models that are still being
actively marketed. We list our ratings for each of these
models for the following applications: general crash-cart
use, in-hospital transport use, and EMS use. For brevity,
we haven’t included a detailed discussion of the features
we require for each application or detailed descriptions of
our findings for the previously evaluated models. For
application-specific features, refer to the Conclusions sec-
tion in our September 2000 update. For details on our pre-
viously evaluated models, refer to the issue of Health
Devices that corresponds to the evaluation date in the
ratings table below.
Ratings
RECOMMENDED MODELS
Five of the models that ECRI has evaluated to date per-
form well and are rated Acceptable for all three applica-
tions considered. We recommend that organizations
consider the following models when buying a unit for gen-
eral crash-cart, in-hospital transport, or EMS applications
(units are listed in alphabetical order):
■ Medtronic Physio-Control Lifepak 12. Note that for
general crash-cart use, the unit should be equipped with
the optional AC power adapter.
■ Philips HeartStart XL. Note that for in-hospital trans-
port of certain patients, a separate transport monitor
Ratings by Application
Supplier/model* Evaluation date
GE CardioServ Feb 1998
Lifepak 12 Sep 2000
HeartStart XL Feb 2002
PIC 50 Current issue
M Series Sep 2000
M Series CCT Current issue
* Units are listed in alphabetical order. Note that we have omitted the previously evaluated Zoll PD 1200 and PD 1400 from this list because the
models are no longer being actively marketed by the supplier.
HEALTH DEVICES 32 (5), May 2003
will be required (see Monitoring on page 196 for fur-
ther discussion).
■ Welch Allyn PIC 50. Note that for general crash-cart
use, the unit should be equipped with the optional Inte-
gral Charger.
■ Zoll M Series
■ Zoll M Series CCT
Selection decisions from among these models should be
based on user preferences, as well as on other organiza-
tion-specific factors, such as device standardization and
the relative importance that purchasers place on the spe-
cific advantages and disadvantages that we identified for
each model. We discuss some of these factors in the Pur-
chasing Considerations section below. For further discus-
sion of product-specific advantages and disadvantages,
refer to each unit’s product profile.
Note that in previous evaluations of defibrillator/
monitors, we rated several units Preferred for general crash-
cart and in-hospital transport applications, while rating a
few older units that did not perform as well against our cri-
teria Acceptable. However, since our last Evaluation, those
Acceptable units were taken off the market, and additional
units have been introduced that offer comparable function-
ality and features to the units we had rated Preferred. Be-
cause we find no specific benefits or shortcomings among
these models that would clearly suggest purchase of one
IN-HOSPITAL PREHOSPITAL
General In-hospital
crash-cart use transport use EMS use
Not Recommended Not Recommended Not Recommended
(with
AC power adapter)
(with
Integral Charger)
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.

above the rest, we now rate all such devices Acceptable
for the appropriate in-hospital applications.
OTHER EVALUATED MODELS
■ The GE CardioServ is Not Recommended for in-
hospital or EMS use.
■ The Zoll PD 1200 and PD 1400 are no longer being ac-
tively marketed, so we have not updated our ratings for
these units.
Purchasing Considerations
Below, we present some factors your facility may want to
consider before making any purchasing decisions. In addi-
tion to this advice, you may find it useful to refer to the
following sections in the September 2000 Health Devices:
■ “Advances in Defibrillator/Monitor Design” (page 302)
■ “Money Matters: Defibrillator/Monitor Costs versus
Capabilities” (page 312)
Most defibrillator/monitors on the market — including
those we recommend in this Evaluation — employ a
biphasic waveform. ECRI recommends that hospitals in-
terested in buying new defibrillators purchase biphasic
units instead of monophasic ones because there is strong
clinical evidence supporting the superiority of the biphasic
waveform. For more information regarding defibrillator
waveforms, refer to the Guidance Article “External
Biphasic Defibrillation: Should You Catch the Wave?” in
the June 2001 Health Devices and the Talk to the Special-
ist article “High-Energy versus Low-Energy External
Biphasic Defibrillators” on page 205 of this issue.
IN-HOSPITAL APPLICATIONS
All defibrillator/monitors currently rated Acceptable for
in-hospital use performed at least satisfactorily against our
criteria. We did find four areas where some differentiation
among the evaluated defibrillator/monitors can be ob-
served: pacing, alarms, human factors, and monitoring.
However, differences are generally small and will have
only minimal impact on selection. User preferences, stan-
dardization, and cost are likely to be more important selec-
tion considerations in most purchasing decisions.
Pacing. The evaluated units differ in the efficacy of how
they respond to ECG leads-off during demand pacing.
(See the article “Response of Pacing to ECG Leads-Off”
on page 193 for a discussion of this topic.)
The Philips HeartStart XL discontinues pacing during
ECG leads-off while in Demand mode. However, the unit
sounds a loud, persistent alarm when a lead is detached
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Evaluation
during pacing and continues to alarm until pacing is re-
initiated. The Welch Allyn PIC 50 acts similarly, although
a standard leads-off (low-level) alarm sounds until the lead
is replaced, at which point the alarm priority increases.
(For the Welch Allyn unit, it should also be noted that
fixed-rate pacing is disabled during an ECG leads-off con-
dition. This means that it is never possible to pace a patient
without a functioning, attached ECG cable, unlike on the
Philips unit.)
The Medtronic Physio-Control Lifepak 12 reverts to
Fixed-Rate mode, which meets our criteria, while the Zoll
M Series and M Series CCT remain in Demand mode and
pace as if responding to asystole. Zoll’s method, while
preferable to stopping pacing altogether, allows for ECG
noise to inhibit pacing beats. Additionally, Zoll’s audible
leads-off alarm during this condition is limited to a single
set of beeps. The leads-off alarm on the Lifepak 12 contin-
ues intermittently until the condition is corrected and
demand pacing resumes.
The differences among the units’ responses to ECG
leads-off will be negligible, as long as patients under-
going external pacing are constantly observed. However,
recognizing that constant attendance may not always be
achieved, we find the response of the Lifepak 12’s pacer to
be the most desirable of the evaluated units.
Alarms. Current defibrillator/monitors provide a vast ar-
ray of optional monitoring capabilities that closely mirror
the monitoring capabilities of many bedside and transport
monitors. As a result, users are likely to take advantage
of these features and use these devices to monitor patients
for extended periods of time. Therefore, ECRI holds
defibrillator/monitors up to performance criteria that are
similar to the criteria applied to conventional bedside and
transport monitors.
A Note on Standardization
Standardizing on any of the defibrillator/monitor
models that we rate Acceptable can be advantageous
for your facility. Standardization simplifies the pur-
chasing process and may help your hospital save
money. And because clinicians would only need to
be trained on and familiar with one model, staff will
know how to operate all the units that are used
throughout the hospital. For further discussion, refer
to the article “Defibrillator Standardization” on page
327 of the September 2000 Health Devices. ◆
HEALTH DEVICES 32 (5), May 2003
Evaluation
Alarms on the units we rated Acceptable generally met
our criteria. However, some disadvantages were noted for
the Medtronic Physio-Control Lifepak 12 and Philips
HeartStart XL units, which were rated Fair for our Alarms
tests. For the Lifepak 12, operators cannot select custom-
ized alarm limits, but rather, must choose one of two pre-
set ranges (wide or narrow). Operators must navigate
through two menus to set this range. Some purchasers may
consider the simplicity of this design an advantage, while
others may be concerned with the inability of clinicians to
select limits. For the HeartStart XL, after an alarm is si-
lenced, the audible alarm does not reactivate, and no mo-
mentary tone sounds to indicate the continuing alarm
condition. The visual alarm is also defeated when the
alarm is silenced.
The Welch Allyn PIC 50, the Zoll M Series, and the
Zoll M Series CCT met all our Alarm criteria and are thus
rated Good overall for this category.
Human factors. As discussed in the product profile for
the Welch Allyn PIC 50, we found the DISCHARGE button
placement for hands-free defibrillation to be less intuitive
than that of other units we’ve evaluated. In most cases,
users are trained on a specific defibrillator and will know
where to find the DISCHARGE button on that unit. How-
ever, in cases where users may be required to use an unfa-
miliar device — such as when rotating clinicians must
respond to a code using a different defibrillator than the
model on which they’ve been trained — defibrillation may
be delayed or not delivered at all if the user cannot locate
the button (see “A Note on Standardization” on page 195).
All Acceptable defibrillator/monitors other than the PIC
50 fulfilled most of our human factors criteria, with only
minor disadvantages noted.
Monitoring. As stated in the Alarms section above, many
of the current defibrillator/monitors provide optional mon-
itoring capabilities that are similar to the capabilities of
bedside and transport monitors. As a result, many of the
ECRI Reprint Policy
All material in ECRI publications is protected by copyright
law. Readers may not copy, resell, or quote this material in
promotional literature.
ECRI does make reprints of individual articles or com-
plete publications available for educational purposes. For
further information, contact the Communications Depart-
ment by phone at +1 (610) 825-6000, ext. 5888, or through
e-mail at communications@ecri.org.
HEALTH DEVICES 32 (5), May 2003
units we have evaluated do not require a transport monitor
to accompany them during in-hospital transport. The Philips
HeartStart XL is an exception: It cannot be equipped with
ETCO2, IBP, NIBP, or temperature. Therefore, a separate
transport monitor will be required for in-hospital transport
of patients who require these monitoring capabilities.
EMS APPLICATIONS
Two issues especially important for EMS use are porta-
bility and battery life. While all units rated Acceptable
for EMS use perform at a satisfactory level in these
categories, we did note some minor advantages and
disadvantages.
The Medtronic Physio-Control Lifepak 12 is the heavi-
est of the Acceptable defibrillator/monitors but was able
to perform our full prehospital battery sequence. When
configured for EMS use, the Philips HeartStart XL, the
Welch Allyn PIC 50, and the Zoll M Series are about 25%
lighter than the other evaluated units. However, the PIC 50
was the only one of these three units to complete our pre-
hospital battery test.* When equipped with SpO 2 monitor-
ing only, the Zoll M Series CCT is fairly compact (part of
the housing that normally holds other monitoring features
is not present). Its weight falls between that of the Lifepak
12 and the three lighter units discussed above, but it was
unable to complete our full battery sequence.
Although these differences in portability and battery
life exist, their clinical impact will be small under most
circumstances, and thus do not make a particular
defibrillator/monitor stand out from the rest in all cases.
Furthermore, the differentiating factors mentioned for
in-hospital applications are not of concern for EMS appli-
cations. The differences in alarms and pacing capabilities
are less important because the patient is constantly at-
tended or observed. EMS personnel are typically familiar
with the devices they use, so familiarity issues are of less
concern as well.
Therefore, purchasers may choose to place more im-
portance on user input regarding any differences. They
may also want to consider how certain features will affect
the usability of the unit. We discourage inclusion of extra
features that add weight, reduce operating time, and in-
crease complexity. ◆
* When equipped with ECG only, the Zoll M Series completed the
prehospital battery sequence. However, it could not complete this se-
quence when equipped with SpO2 monitoring, a desirable capability for
EMS use. Since our evaluation of the M Series in September 2000, Zoll
has made available their higher-capacity XL battery, which can be used
with this unit. We have not evaluated the M Series in this configuration.
©2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
 IPM
Procedure

Infusion Devices
Inspection and Preventive Maintenance Procedure

Procedure number. 416-20030501 (Major)

UMDNS information. Infusion Controllers [11-010] ■ Infusion Pumps,

Ambulatory [16-491] ■ Infusion Pumps, General-Purpose [13-215] ■ Infusion
Pumps, Micro [16-722] ■ Infusion Pumps, Multichannel [17-634] ■ Infusion
Pumps, Patient-Controlled Analgesic [16-924] ■ Infusion Pumps, Syringe
[13-217] ■ Pumps, Enteral Feeding [13-209]

Where commonly used. All patient care areas, homes

Scope. This procedure applies to most types of electromechanical devices

that regulate the delivery of fluids to a patient, including general-purpose
microinfusion pumps, multichannel pumps, microinfusion pumps, patient-
controlled analgesic pumps, syringe pumps, ambulatory pumps, enteral feed-
ing pumps, and infusion controllers.

Risk level. High

Major inspection intervals. 12 months; however, as discussed in the proce-

dure, it may be possible to establish a longer interval for general-purpose infu-
sion pumps

Minor inspection intervals. None

About This IPM Procedure
We have revised our inspection and preventive mainte-
nance (IPM) procedure covering infusion devices to reflect
our perspectives on the National Patient Safety Goals for
2003 set by the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) — specifically, the
goals covering infusion and alarm safety. This procedure,
which is part of the Health Devices IPM System, covers a
wide range of infusion devices, including general-purpose,
syringe, and patient-controlled analgesic (PCA) pumps. It
is designed for routine IPM; its tasks are not as compre-
hensive as those recommended for acceptance testing. The
updated version of the procedure is being made available
to users of the IPM System through the IPM tab in the
members area of ECRI’s Web site (www.ecri.org).
The Health Devices IPM System is a Windowsâ-
compatible CD-ROM program that includes dozens of
ready-to-use procedures for verifying equipment perfor-
mance and safety. The procedures and forms in the IPM
System have been developed, tested, and updated to com-
ply with quality standards and to take safety standards into
account. For more information about this product, contact
ECRI’s Communications Department by phone at
+1 (610) 825-6000, ext. 5888, or through e-mail at
communications@ecri.org.
Overview
Infusion devices are often used when accurate fluid-
delivery rates are required over long periods of time.
There are a wide variety of such devices:
■ General-purpose infusion pumps and infusion control-
lers are used for many of the same applications and
have similar alarm features. However, infusion pumps
infuse under pressure, whereas controllers regulate a

©2003 ECRI. Member hospitals may reproduce this page for internal distribution only. HEALTH DEVICES 32 (5), May 2003
IPM
Procedure
gravity infusion. Most general-purpose infusion pumps
have a flow range of 0.1 to 999 mL/hr, while most con-
trollers regulate flow in a range of 3 to 300 mL/hr and
are less accurate.
■ Multichannel infusion pumps consist of two or more
general-purpose pumps within one chassis.
■ Microinfusion pumps are similar to general-purpose
pumps but have lower maximum flow settings and may
have greater flow resolution; they are used in neonatal
critical care areas.
■ PCA pumps deliver pain medication on patient demand
by handswitch activation; they are programmed for
drug concentration and dose volume, lockout interval,
and maximum dose.
■ Syringe pumps are used to infuse volumes £60 mL at
rates typically <50 mL/hr by advancing the plunger or
sliding the barrel of a conventional syringe installed in
the pump.
■ Ambulatory pumps are small and do not rely on line
power or gravity for operation. They are commonly
used to infuse antibiotics, analgesics, chemotherapeutic
agents, and total parenteral nutrition solutions.
■ Enteral feeding pumps are typically used to deliver
enteral solution or food mixtures to a patient’s stomach
or small intestine through an enteral feeding tube.
Except for syringe pumps, ECRI recommends that in-
fusion devices and/or their infusion sets provide free-flow
protection (meaning that, if a set or reservoir is removed
from an operating pump and is not manually clamped, no
fluid will flow under gravity pressure). As of January 1,
2003, JCAHO surveyors are assessing accredited U.S.
healthcare facilities for compliance with JCAHO’s 2003
National Patient Safety Goals, including a recommenda-
tion to “ensure free-flow protection on all general-use and
[PCA] intravenous infusion pumps used in the organiza-
tion.” The safety goal for pumps applies to any accredited
healthcare organization that uses these pumps.
Some pumps now have dose error reduction systems
that warn users of incorrect physician/pharmacy orders,
calculation errors, and misprogramming that would result
in significant underdelivery or overdelivery of a drug or
electrolyte. These systems operate on dose limits that are
defined by a facility for its intravenous (IV) and epidural
drugs before the pumps are put into use. Although the func-
tioning of these systems would not typically be assessed
during a major inspection, some models have a dedicated
log that could be downloaded before starting the inspec-
tion. Data from these logs can be useful in determining if
HEALTH DEVICES 32 (5), May 2003 ©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
limits have been appropriately set and for performing
an infusion therapy failure mode and effects analysis
(FMEA).
Inspecting alarms on infusion devices is also a con-
sideration. Another of JCAHO’s National Patient Safety
Goals is one covering the effectiveness of clinical alarm
systems. The goal does not require measurement of alarm
sound levels, and it does not require more frequent in-
spections than would otherwise be required for infusion
pumps. But a facility will need to include infusion devices
in its inventory of devices with alarms, determine which
(if any) alarms are critical to patient safety, and ensure that
staff are alerted to and promptly respond to those critical
alarms. (In many cases, however, infusion pump alarms
are not critical and do not require immediate attention. Fa-
cilities must ensure that clinician priorities are not inappro-
priately shifted to these less critical infusion alarms.)
While verification of alarm function and qualitative as-
sessment of alarm volume during routine inspections may
be part of implementing JCAHO’s goal, it is more impor-
tant to examine the environment in which pumps are used
and consider factors that might prevent a nurse from hear-
ing a critical alarm. Take into account the fact that nurses
may not always be close to a patient’s room, that patient
room doors might be closed, and that pumps might be
used by mobile patients. (Note, however, that these types
of assessments are generally outside the scope of IPM pro-
grams.) Occasionally, a facility may need to consider im-
plementing remote alarms, possibly by using the nurse call
feature on some infusion devices. See the November 2002
and March 2003 issues of Health Devices for further guid-
ance on alarm safety.
Citations from ECRI Publications
From Health Devices
Enteral feeding pumps [evaluation], 1984 Nov;14(1):
9-30.
Infusion controllers [evaluation], 1985 May;14(7):219-56.
Syringe infusion pumps [evaluation], 1987 Jan;16(1):
3-32.
Ambulatory insulin infusion pumps [evaluation], 1987
Nov;16(11):351-76.
Ambulatory infusion pumps [evaluation], 1991 Sep;20(9):
324-58.
IV free-flow — still a cause for alarm [perspective], 1992
Sep;21(9):323-8.

ECRI responds to FDA Public Health Advisory on IV
free-flow [hazard report], 1994 Jun;23(6):256-7.
General-purpose infusion pumps [evaluation], 1997 Feb;
26(2):50-75.
Infiltration during infusion therapy [User Experience Net-
work], 1998 Jan;27(1):39.
Infusion pump analyzers [evaluation], 1998 Apr-May;
27(4-5):124-47.
Infusion pump inspection frequencies: how often is in-
spection really needed? [guidance article], 1998
Apr-May;27(4-5):148-50.
General-purpose infusion pumps [update evaluation], 1998
Apr-May;27(4-5):151-70.
Patient-controlled analgesic infusion pumps [evaluation],
2001 Jun;30(6):157-85.
Patient-controlled analgesic infusion pumps: evaluating
the Deltec CADD-Prizm PCS II [update evaluation],
2001 Sep-Oct;30(9-10):360-4.
General-purpose infusion pumps [evaluation], 2002 Oct;
31(10):353-84.
Abbott Omni-Flow 4000 Plus [evaluation], 2002 Oct;
31(10):385-7.
From Health Devices Alerts
JCAHO’s 2003 National Patient Safety Goal for infusion
pump free-flow protection: assessing general-purpose
and patient-controlled analgesic pumps [special report
SR0018], 2003 Mar 21.
Test Apparatus,
Supplies, and Parts
■ Ground resistance ohmmeter
■ Leakage current/electrical safety tester
■ Pressure meter (³50 psi)
■ Infusion tester (optional)
■ Electronic balance (if infusion tester cannot measure
PCA dose volume accuracy)
■ Small beaker (if a balance is used)
■ 50 mL graduated cylinder (1 mL graduations)
■ Stopwatch
■ Disposable(s) specified for device to be inspected
■ Fluid container of IV solution or degassed water
■ U-100 insulin syringe
■ IV pole
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
IPM
Procedure
Procedure
Before beginning an inspection, carefully read this pro-
cedure and the manufacturer’s instruction and service
manuals; be sure that you understand how to operate the
equipment, the significance of each control and indicator,
and the alarm capabilities. Also, review special IPM pro-
cedures or frequencies recommended by the manufacturer.
Note that, for some models of general-purpose infusion
pumps, an inspection interval longer than one year can be
justified by a careful review of inspection and repair trends
(see “Infusion Pump Inspection Frequencies: How Often
Is Inspection Really Needed?” in the April-May 1998
Health Devices).
Set up the infusion device according to the manufac-
turer’s instructions, using an IV pole, a container of out-
dated IV solution or degassed water, and the specified
infusion set. Be sure that the set is properly primed and
that bubbles are removed. Disposable accessories should
be replaced at least weekly, and more frequently with
heavy use.
For settings ³1 mL/hr, flow accuracy is most conve-
niently determined with an infusion tester. If a tester is not
available, calculate flow rate by dividing the volume col-
lected in a 50 mL graduated cylinder (1 mL graduations)
by the delivery time measured with a stopwatch. The accu-
racy of a PCA pump’s patient-demand dose or bolus can
be determined by measuring the mass of a bolus in a small
beaker on an electronic balance (200 mg range, resolution
to 0.1 mg).
QUALITATIVE TASKS
Chassis/Housing. Examine the infusion device for over-
all condition. The chassis should be clean and free from IV
or enteral solution residue, especially near moving parts
(e.g., thumbwheel switches, pump or controller mecha-
nisms). Also check for dried solution deposits on accessi-
ble air-in-line sensors, pressure-sensing mechanisms, and
infusion set/cassette locking mechanisms. Check that
labels and markings are legible.
Mount. Screws and brackets that attach the infusion de-
vice to an IV pole should be secure and functioning. If the
device is mounted on a stand or cart, examine the condi-
tion of the mount. Also examine the pole, stand, or cart.
Casters/Brakes. If the infusion device is mounted on a
dedicated IV pole, stand, or cart that moves on casters,
check their condition. Look for accumulations of lint and
thread around the casters, and be sure that the casters turn
HEALTH DEVICES 32 (5), May 2003
IPM
Procedure
and swivel, as appropriate. Check the operation of brakes
and swivel locks, if present.
AC Plug. Examine the AC power plug for damage. At-
tempt to wiggle the blades to determine that they are se-
cure. Shake the plug and listen for rattles that could
indicate loose screws. If any damage is suspected, open
the plug and inspect it.
If the device or its IV pole has an electrical receptacle,
inspect it by inserting an AC plug and checking that it is
held firmly. If the receptacle is used frequently, consider a
full inspection (see Procedure 437, Electrical Receptacles,
in the IPM System).
Line Cord. Inspect the cord for signs of damage. If dam-
aged, either replace the entire cord or, if the damage is
near one end, cut out the defective portion. Be sure to wire
the new power cord or plug with the correct polarity.
Strain Reliefs. Examine the strain reliefs at both ends of
the line cord. Be sure that they hold the cord securely.
Cables. Inspect drop-sensor and remote air-in-line detec-
tor cables for general condition. Examine cables carefully
to detect breaks in the insulation. Ensure that they are
gripped securely in the connectors at each end to prevent
rotation or other strain.
Fittings/Connectors. Examine any electrical cable con-
nectors (e.g., drop sensor, nurse call) for general condi-
tion. Electrical contact pins or surfaces should be straight
and clean. Check any spill-protection connector caps for
signs of damage.
Controls/Switches. Before moving any control switches,
dials, or knobs, check their positions. If any appear inordi-
nate (e.g., volume-infused counter or audible alarm level
at the end of its range), consider the possibility of inappro-
priate clinical use or of incipient device failure. Record the
settings of those controls (e.g., occlusion pressure limits)
that should be returned to their original positions follow-
ing the inspection. Examine all controls and switches for
physical condition, secure mounting, and correct motion.
Where a control should operate against fixed-limit stops,
check for proper alignment, as well as positive stopping.
Check membrane switches for membrane damage (e.g.,
from fingernails, pens). During the inspection, be sure to
check that each control and switch performs its proper
function.
Battery. If the device uses a battery or batteries, assess
the battery status for function and/or inspect the physical
condition of batteries and battery connectors, if readily ac-
cessible. Operate the infusion device on battery power dur-
ing the entire inspection to check that the battery has been
HEALTH DEVICES 32 (5), May 2003 ©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
charged and can hold a charge. If a low-battery alarm oc-
curs, check to ensure that the alarm is properly displayed,
then continue the inspection using line power. Note how
long the infusion device has been operating and the condi-
tions under which the low-battery alarm occurred. Fully
charge the battery before returning the infusion device to
use. When a battery must be replaced, label the new
battery with the date.
Indicators/Displays. During the inspection, confirm the
operation of all indicators, visual displays, and display
backlighting, if the device is so equipped. Be sure that all
segments of a digital display function. (Note: Many infu-
sion devices automatically check indicator and display
function when turned on or during a manually activated
self-test.) As appropriate, verify the date/time, default
settings, and malfunction log.
Flow-Stop Mechanism. Turn the power off with the infu-
sion set primed and loaded in the device. With all tubing
clamps open and the fluid container as high above the de-
vice as the tubing will allow, verify that no fluid flows out
of the set as it hangs straight down from the device.
If the device incorporates a mechanism that automati-
cally closes the set or requires the set to be manually
closed before it is removed from the device, remove the
set from the device (tubing clamps still open) and again
verify that no fluid flows out of the set. Note: Some PCA
and ambulatory pump sets have an integral positive-
pressure (antisiphon) valve that may allow small amounts
of fluid to flow under conditions of maximum head height.
For PCA therapy, however, the reservoir should be se-
cured to the pump and not suspended above it.
Lockout Interval. Note: This test applies only to PCA
pumps. Program the pump for its minimum lockout inter-
val (typically 3 to 6 minutes). Activate a dose, and verify
that a second dose cannot be activated until the pro-
grammed lockout time has elapsed.
Alarms. Many infusion device alarm capabilities can be
checked qualitatively. The following procedures include
tests for the most common alarm conditions. Check the
operator’s manual to see how the alarm should work.
When an alarm occurs, check to see that both the audible
and the visual alarms are activated and that flow stops.
Confirm appropriate alarm volume, as well as the opera-
tion of any volume control.
Air-in-Line. Note: This test may not apply to syringe and
enteral pumps, which typically do not have air detectors.
With the device operating at 100 mL/hr, test its air detec-
tor by introducing a small air bubble into the system. This

can be done either by inverting the drip chamber briefly or
by using a syringe to inject air into an injection port of the
IV tubing between the fluid container and the air-in-line
detector. (Sensitivity to air volumes of <50 mL is likely to
result in nuisance alarms; most devices will trigger an
alarm for >100 mL air. Volumes of 50 and 100 mL can be
approximated by 5 and 10 units, respectively, from a
U-100 insulin syringe.)
Occlusion. If the device delivers from an external fluid con-
tainer, verify upstream occlusion detection by activating
infusion with the tubing clamped just below the container.
Verify downstream occlusion detection by activating infu-
sion with the infusion set’s distal connector capped.
Infusion Complete. If the total volume to be infused can be
preset, set it to a low volume (e.g., 5 mL) and operate the
pump at a high-flow setting. Verify that an alert activates
when the volume is delivered and that the flow setting
drops to a low (typically £5 mL/hr) keep-vein-open
(KVO) rate. For pumps that deliver from a syringe or vial,
verify the activation of near-empty and empty alerts.
Open Door/Misloaded Infusion Set. For units with this fea-
ture, verify the activation of an alert or an alarm during
setup and operation.
Nurse Call. Note: Perform this test only if this function is
used. Some pumps have a relay contact closure that acti-
vates a nurse call system when an alarm condition occurs.
This requires a special cable that connects the pump to the
nurse call system. If the infusion device has this capability
and is used in any clinical location, connect the cable, and
simulate one or more of the above alarm conditions to de-
termine whether they activate the nurse call. Alternatively,
use an ohmmeter to check that a change in resistance (either
low to high or high to low) occurs between the two con-
ductors of the cable when an alarm condition is created.
Labeling. Check that all necessary placards, labels,
conversion charts, and instruction cards are present and
legible.
Accessories. Check the condition of external air-in-line
and drop sensors, if so equipped. Clean sensors according
to the manufacturer’s instructions. For syringe pumps, ver-
ify that the correct brand of syringe is selected. Insert a sy-
ringe, and verify that the pump correctly identifies its size.
QUANTITATIVE TASKS
Grounding Resistance. Measure and record the resis-
tance between the grounding pin of the power cord and ex-
posed (unpainted and not anodized) metal on the chassis
with an ohmmeter, electrical safety tester, or multimeter
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
IPM
Procedure
with good resolution of fractional ohms. Grounding resis-
tance should not exceed 0.5 W. If the device or its IV pole
has an accessory outlet, check its grounding to the main
power cord.
Chassis Leakage Current. Measure leakage current be-
tween the chassis and ground with the grounding conduc-
tor temporarily opened. Measure chassis leakage current
while all accessories normally powered from the same line
cord are connected. This includes other equipment that is
plugged into the primary device’s accessory receptacles, as
well as equipment plugged into a multiple-outlet strip so
that all are grounded through a single line or extension
cord. Perform measurements with this equipment both
turned on and turned off. Chassis leakage current to
ground should not exceed 300 mA.
Flow Accuracy. Determine the flow accuracy at two
typical flow settings that are ³1 mL/hr (e.g., 10 and 100
mL/hr). Use an infusion pump tester, or collect the output
in a graduated cylinder. Use a stopwatch or a watch with a
second hand to time the delivery into the graduated cylin-
der until at least 10 mL is collected. Record the time inter-
val and volume collected, and calculate the delivery rate in
mL/hr.
To calculate flow error, use the following formula:
Actual rate – Desired rate
% Error = x 100%
Desired rate
Exercise extreme care during measuring to ensure accu-
rate test results. Most IV infusion pumps are specified to
deliver within 5% of the flow setting, which is required for
critical applications. (Note: Negative and positive flow
errors represent underdelivery and overdelivery, respec-
tively.) Enteral feeding pumps and infusion controllers are
typically specified to deliver within 10% of the flow set-
ting (or drop rate). Be sure that infusion devices are used
appropriately (e.g., infusion controllers should not be used
for critical IV infusions).
If the infusion device is designed to count drops and the
delivery rate can be set only in drops/min, do not attempt
to convert to mL/hr. Converting drops to milliliters is
complex and only grossly assesses the device’s ability to
deliver fluid volumes. Instead, operate the device for 3 to
5 minutes at a midrange rate setting, then count the drops
falling into the drip chamber for 2 minutes. Operate the
device for several more minutes, and repeat the count. Cal-
culate the number of drops per minute for each trial, and
average the two rates if they differ. (Slight variations may
be due to the control circuitry correcting for errors.)
HEALTH DEVICES 32 (5), May 2003
IPM
Procedure

Dose (Bolus) Volume Accuracy. Note: This test applies
only to PCA pumps. Use an infusion tester if it is capable
of measuring the accuracy of patient-demand boluses.
Otherwise, use an electronic balance to determine volume
accuracy by converting mass to volume. (For example,
1 g H2O = 1 mL. This equivalence can also be applied to
most other test solutions, such as normal saline.) Program
the pump for a concentration of 1.0 mg/mL and a dose of
1 mg. Weigh a small beaker before and after collecting a
bolus. Collect and determine the average mass of three
1 mg boluses.
To calculate volume error, use the following formula:
Actual mass – Desired mass
% Error = ´ 100%
Desired mass
Dose volumes should be accurate to within 5%.
Maximum Pressure. Note: This task does not apply to
infusion controllers. If the unit has a user-selectable pres-
sure setting, this test should be performed at the highest
setting. Connect the distal end of the primed administra-
tion set to a pressure meter, or use an infusion pump tester
(if the tester is equipped to perform this task). Start infu-
sion at a commonly used flow setting (e.g., 10 or 100
mL/hr), and record the maximum pressure at which the
occlusion alarm activates. Restart the pump to ensure that
maximum infusion pressure has been attained. The mea-
sured pressure should be within 1 psi of the manufac-
turer’s specification for maximum pressure.
Preventive Maintenance
Clean. Clean the exterior and the interior of the infusion
device, if required. Pay particular attention to solution de-
posits on mechanical infusion control mechanisms, drop
sensors and air-in-line detectors, and occlusion- or
pressure-sensing mechanisms.
Calibrate. Calibrate per the manufacturer’s specifica-
tions.
Replace. Replace the primary battery, the clock battery
(or cell), and/or the memory battery (or cell), if necessary,
and label the new one with the date.
Before Returning to Use
Ensure that the battery is fully charged. For pumps with
user-selectable occlusion-pressure alarms, reset the limit to
the facility’s default setting. ◆

Missed the May 21 Audio

Conference?

On May 21, 2003, ECRI held the latest installment in its

audio conference series: “HIPAA Security Rules and Medi-
cal Technology.” Speakers, including representatives from
ECRI and the American College of Clinical Engineering,
provided an overview of the Health Insurance Portability
and Accountability Act and the challenges it presents for
healthcare facilities.
Audiotape and CD-ROM recordings of this conference —
plus course materials that were provided to registrants —
are available from ECRI. The cost for the audiotape plus
the course materials is $229 ($49 for conference regis-
trants). The cost for the CD-ROM plus the course materials
is $239 ($89 for conference registrants). To order, please
contact ECRI’s Communications Department at +1 (610)
825-6000, ext. 5888, or at communications@ecri.org. ◆

HEALTH DEVICES 32 (5), May 2003 ©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
 ECRI Problem
Reporting System

Problem Reports
Policy statement. ECRI encourages members, healthcare providers, patients,
and suppliers to report all medical-device-related incidents and deficiencies to us
so that we can determine whether a report reflects a random failure or one that is
likely to recur and cause harm. Reports can be generic or model specific. We
add all reports to our internal confidential databases to track trends of device
failure or lot-specific defects. Although many reports do not result in a published
article, we inform the reporting party of our findings or opinions when appropri-
ate. As soon as we become aware of device hazards and problems, we inform
the suppliers and invite them to respond constructively.

If our investigations yield information that should be communicated to the

healthcare community, we publish the information in Health Devices as either
a Hazard Report or a User Experience Network™ (UEN™) article, depending
on the level of risk associated with the problem. Member hospitals may repro-
duce these reports for internal distribution only. This policy does not apply to
other articles in Health Devices, unless otherwise noted.
Submitting a report. Please report problems to us by mailing or faxing one
of the problem reporting forms in your Health Devices binder, by sending us a
letter, by completing the online form available at www.ecri.org/problemreport,
or by calling +1 (610) 825-6000. The identity of the reporting individual or
institution is never revealed without permission.

Hazard Report
Imperfect Protection: Syringe Safety Mechanisms Can Fail

failures resulting in user injury, with syringes from a

PROBLEM
A member hospital reported that on several of its protec-
tive syringes, either the needle failed to fully retract into
the syringe barrel or the retraction mechanism failed to re-
tain the needle inside the barrel after the safety mechanism
was activated. No injury occurred at the time; however,
this type of device failure could easily result in a needle-
stick exposure.
Although the hospital’s report describes incidents re-
lated to the use of one particular syringe model, this prob-
lem is not unique. A search of ECRI’s Problem Reporting
System and Health Devices Alerts databases, along with
the U.S. Food and Drug Administration’s (FDA) MAUDE
database, reveals multiple reports of protective syringe
variety of suppliers named in the different reports. Further-
more, it’s likely that the hazard is even more prevalent
than these reports indicate since healthcare workers don’t
always report device failures when there is no associated
injury.
BACKGROUND
ECRI divides protective syringes into two general catego-
ries: disposable protective syringes and needle guards.
Disposable protective syringes consist of a needle pre-
attached to a syringe that incorporates a safety mechanism.
Needle guards incorporate the safety mechanism in the
needle itself. Various types of safety mechanisms are

©2003 ECRI. Member hospitals may reproduce this page for internal distribution only. HEALTH DEVICES 32 (5), May 2003
ECRI Problem
Reporting System
available; for example, the mechanism may cover the
needle with a shield or retract the needle into the syringe.
These mechanisms are intended to be activated after the
injection has been delivered; in properly working devices,
they will prevent the needle from making further contact
with any surface or individual.
Unfortunately, safety devices can fail for a variety of
reasons. These include manufacturing issues such as im-
proper assembly, parts not meeting specifications for size
or strength, or just random failure. User error can also be a
factor — the user may activate the safety mechanism im-
properly or may fail to activate it at all.
DISCUSSION
In the reported incidents, the facility was using a protec-
tive syringe that was designed to automatically retract the
needle into the syringe barrel after use. Once retracted, the
needle should have been completely enclosed in the sy-
ringe barrel and should not have protruded even when the
syringe was held vertically with the needle-end down. In-
stead, in several cases, the needle tip still protruded past
the barrel tip after the safety mechanism was activated.
It is not clear whether the needle retracted only partially
in these instances or whether it reemerged after retraction.
It is also not clear whether the failure of the safety mecha-
nism in these incidents resulted from some defect in the
device or from user error — although the latter seems
unlikely, since the incidents occurred during training
ECRI’s Hazard Reports
A Hazard Report describes a possible source of peril, danger,
or difficulty. We publish reports about those units in which
we have identified a fault or design feature that might, un-
der certain circumstances, place patients or users at risk.
These reports describe the problem and ECRI’s recom-
mendations on how to correct or avoid it. Publication of a
report on a specific brand name and model of device in no
way implies that competitive devices lack hazardous
characteristics.
When deciding whether to discontinue using a device
that ECRI believes poses a risk, staff should balance the
needs of individual patients, the clinical priorities, and the
availability of safer or superior products against the infor-
mation we provide. Clinical judgment is more significant
than an administrative, engineering, or liability decision.
Users can often take precautions to reduce the possibility
of injury while waiting for equipment to be modified or
replaced.
HEALTH DEVICES 32 (5), May 2003
sessions. (Unfortunately, such uncertainty is typical; most
reports of exposure incidents simply indicate that the
safety mechanism failed but do not describe how or why.)
Regardless of the cause, these reports illustrate an im-
portant point: Although many protective syringes and
other needlestick-prevention devices (NPDs) offer effec-
tive protection against needlestick injuries, these devices
sometimes fail. Healthcare workers should not become
complacent about needlestick hazards simply because a
syringe is equipped with a safety device.
Staff need to be aware
that even safety devices
can fail.
We urge all healthcare institutions to ensure that their
staff members are aware of the hazards posed by sharps
injuries, including injuries from protective devices that
have not activated properly. Healthcare worker training
and review sessions on proper protective device activation
and disposal methods should include information on
proper handling when safety devices fail. (For example, if
a safety device does not activate, the user should never try
to force it to function, such as by manually sliding a sheath
over a needle.) These sessions should also cover the steps
required for reporting exposures and device failures.
At the same time, the occasional failure of safety
devices should not discourage healthcare workers from
diligently using NPDs. The importance of needlestick-
prevention technology was reinforced recently in a report
published by the Exposure Prevention Information Net-
work (EPINet) coordinated by the International Healthcare
Worker Safety Center at the University of Virginia.*
The report describes a substantial drop in needlestick
injuries from 1999 to 2001: The number of injuries per
100 occupied beds dropped from 40 to 25 at teaching fa-
cilities and from 34 to 18 at nonteaching facilities. The
reduction was attributed primarily to the requirements of
the U.S. Occupational Safety and Health Administration
(OSHA), which mandate that U.S. hospitals evaluate and
deploy NPDs.
* Perry J, Parker G, Jagger J. 2001 percutaneous injury rates [EPINet
report]. Adv Expo Prev 2003;6(3):32-6. Available from Internet:
www.med.virginia.edu/medcntr/centers/epinet/benchmark01.pdf.
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.

RECOMMENDATIONS
1. Remind users that protective syringes occasionally fail.
Inform users that they should not assume the needle is
shielded just because the safety mechanism has been
activated. Instruct them that all syringes should be dis-
posed of in a sharps container immediately after use.
2. If not already in place, institute periodic mandatory
training sessions that review device protocols such as
proper use and disposal, as well as protocols for report-
ing device failures and exposure incidents. Remind
users not to try to manually activate a safety feature
after it has failed.
3. Report all failures to the supplier, even if there is no in-
jury. This information is useful for product improvement
efforts. Talk to device suppliers — in advance when
possible — about their procedures for handling device
failure and product return. Incorporate this information
into training sessions.
Talk to the Specialist
High-Energy versus Low-Energy External Biphasic Defibrillators
Question. Should the energy levels offered by an
external biphasic defibrillator affect our purchasing
decision?
Answer. Currently, there is no clear evidence that it
should. While there is strong evidence for the superior-
ity of biphasic over monophasic waveforms for achiev-
ing defibrillation, our literature review reveals no
similar evidence supporting a significant difference in
efficacy between high-energy and low-energy biphasic
waveforms. An external biphasic defibrillator is typi-
cally referred to as high-energy if its waveform is de-
signed for use at energies up to 360 J, and low-energy
if designed for use at energies not exceeding 200 J.
The entrance of the biphasic waveform into the
defibrillator marketplace spawned a number of ques-
tions (such as this one) that did not exist with mono-
phasic units. The energy delivered by a monophasic
waveform remains fairly consistent among suppliers. In
contrast, the biphasic waveforms offered by different
suppliers will differ in their shape and in the energies
and current they deliver. It’s likely that the optimal en-
ergy level for biphasic defibrillators will vary with the
units’ waveform characteristics. That is, an appropriate
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
ECRI Problem
Reporting System
4. Forward a copy of device-failure reports to ECRI and
appropriate government agencies.
UMDNS information. Syringes, Plunger, Hypodermic,
Protected Needle [18-070]
Supplier. These devices are available from a variety of
suppliers; consult ECRI’s Health Devices Sourcebook or
Health Devices International Sourcebase for a list of
companies.
Need to know more? ECRI’s Sharps Safety and
Needlestick Prevention guide is a comprehensive resource
for evaluating and selecting sharps-safety technologies.
For more information or to obtain a copy, contact ECRI’s
Communications Department by phone at +1 (610)
825-6000, ext. 5888, or by e-mail at communications@
ecri.org. ◆
energy dose for one biphasic waveform may be inap-
propriate for another. Therefore, unlike monophasic
defibrillators, each biphasic defibrillator may have dif-
ferent capabilities and different use recommendations
based on the manufacturer’s design and clinical
research.
(continued on page 206)
Talk to the Specialist
In this column, we provide answers to questions fre-
quently asked of ECRI’s specialists. Members of either
the Health Devices System or the SELECTplus™ Program
are encouraged to contact ECRI’s experts to pose ques-
tions such as these or to seek assistance on healthcare
technology issues. This type of direct, personal assis-
tance — which can save you valuable time, effort, and
money — is a membership benefit available to all individ-
uals at subscribing healthcare facilities.
ECRI’s specialists can be reached by telephone at
+1 (610) 825-6000; by fax at +1 (610) 834-1275; by
mail at 5200 Butler Pike, Plymouth Meeting, PA 19462,
USA; or through e-mail at healthdevices@ecri.org.
HEALTH DEVICES 32 (5), May 2003
ECRI Problem
Reporting System
User Experience Network
ECG Filters Do Not Meet Specifications on Zoll M Series and
M Series CCT Defibrillator/Monitors
HOSPITAL
During acceptance testing, we found that the performance
of the ECG filters of the Zoll M Series defibrillator/
monitors does not meet the supplier’s specifications. Ac-
cording to the System Configuration menu on the unit, as
well as the operator’s manual, the unit can be operated
with a filter setting of 0.5 to 30 Hz, 0.5 to 40 Hz, or 1 to
30 Hz. However, we found the actual upper filter values
(called the upper-cutoff frequencies) for these settings to
be 21, 27, and 19 Hz, respectively.
ECRI
Zoll has informed us that this problem also affects another
of its defibrillator/monitors, the M Series CCT.
ECG monitors — including those used in defibrillator/
monitors — are designed to acquire a physiologic signal
while filtering out extraneous electrical noise and other
nonphysiologic artifacts. The frequencies admitted by the
ECG filter are called the unit’s bandwidth, or frequency re-
sponse. The appropriate bandwidth for an ECG monitor de-
pends on how the waveform will be used — specifically,
(continued from page 205)
Although many suppliers are using their particular
waveforms as selling points for their units, there isn’t
enough clinical evidence to suggest that one biphasic
waveform is better than another. ECRI believes that all
currently available biphasic defibrillators are compati-
ble with American Heart Association (AHA) guide-
lines.* Therefore, in selecting among the available
biphasic units, the waveform shape and energy should
not be a deciding factor. Instead, you should use the
same purchasing criteria for biphasic units that you
would use to assess any other defibrillator — including
factors such as ease of use and ability to standardize
throughout the hospital.
* American Heart Association (AHA). Guidelines 2000 for cardio-
pulmonary resuscitation and emergency cardiovascular care: an interna-
tional consensus on science. Circulation 2000 Aug 22;102(8 Suppl).
HEALTH DEVICES 32 (5), May 2003
on whether its primary use will be for rhythm recognition
or diagnosis.
The reported discrepancy deals with the Zoll units’
performance in monitoring mode, which is their normal
operating mode. In this mode, the primary function of the
ECG is to identify heart rate and rhythm so that a clinician
can judge whether defibrillation is necessary. The Associa-
tion for the Advancement of Medical Instrumentation’s
(AAMI) EC13 standard recommends an ECG bandwidth
for monitoring mode of 0.5 to 40 Hz.* Such a range is suf-
ficient to identify most sinus rhythms and arrhythmias; at
the same time, it avoids electrical noise radiating from
50 Hz and 60 Hz power lines, as well as low-frequency
“baseline wander” caused by respiration and electrode
impedance changes.
The Zoll units have three filter settings available for
monitoring mode. Testing by Zoll has shown that the
* American National Standards Institute (ANSI)/Association for the Ad-
vancement of Medical Instrumentation (AAMI). Cardiac monitors, heart
rate meters, and alarms. ANSI/AAMI EC13:2002. 2002.
For more information on biphasic waveforms,
refer to the Guidance Article “External Biphasic
Defibrillators: Should You Catch the Wave?” in the
June 2001 Health Devices.
UMDNS information. Defibrillator/Pacemakers, Exter-
nal [17-882] ■ Defibrillators, External, Automated
[17-116] ■ Defibrillators, External, Semi-Automated
[18-500] ■ Defibrillators, External, Manual [11-134] ■
Pacemakers, Cardiac, External, Noninvasive Electrodes
[16-516]
Supplier. These devices are available from a variety of
suppliers; consult ECRI’s Health Devices Sourcebook
or Health Devices International Sourcebase for a list of
companies. ◆
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.

Zoll M Series and M Series CCT
ECG Filter Performance
Actual Upper-Cutoff
Specified Bandwidth Frequency*
0.5 to 30 Hz 21 Hz
0.5 to 40 Hz 27 Hz
1 to 30 Hz 19 Hz
* Approximate values.
actual upper-cutoff frequencies for these settings are ap-
proximately 9 to 13 Hz lower than those specified, as illus-
trated in the table on this page.
Although the performance of the Zoll units falls below
that recommended in the AAMI standard, ECRI believes
that the effect of this reduced bandwidth on rate and
rhythm recognition will be negligible. While investigating
this problem, we compared the performance of the Zoll M
Series to another supplier’s defibrillator, which had a con-
firmed upper-cutoff frequency of 40 Hz. We tested the two
units with a number of simulated ECG waveforms, both
shockable and nonshockable. We found small differences
between the units’ displayed waveforms (on both the
screen and the strip-chart recorder), but the differences
were not clinically significant for identifying cardiac
rhythm: Although the M Series showed some loss of QRS
amplitude and some smoothing of fine waveform details,
the ECG rhythm was apparent in all cases.
While the performance of the Zoll units should not
present a problem, we do believe that devices should meet
their listed specifications. We are satisfied with Zoll’s cor-
rective action to reconcile the units’ specifications with
their actual performance, as described below.
On a final note: Users need to recognize that monitoring-
mode bandwidth is not designed for diagnostic-quality
ECG recording and should not be used for this purpose. If
diagnostic-quality recording is desired, users should
©2003 ECRI. Member hospitals may reproduce this page for internal distribution only.
ECRI Problem
Reporting System
instead employ a 12-lead ECG machine to print an ECG
strip chart.
SUPPLIER’S CORRECTIVE ACTION
Zoll has updated the operator’s manuals for the M Series
and M Series CCT units to reflect the actual filter perfor-
mance for ECG monitoring. In April, the company re-
leased a software revision (v. 35.00) for the M Series that
corrected the labeling in the System Configuration menu.
Updated software (v. 54.00) for the M Series CCT is
scheduled for release by the end of July. These changes
will be implemented on all new units and will be provided
for free to current users upon request.
UMDNS information. Defibrillator/Pacemakers, External
[17-882] ■ Defibrillators, External, Manual [11-134] ■
Defibrillators, External, Semi-Automated [18-500] ■ Pace-
makers, Cardiac, External, Noninvasive Electrodes
[16-516]
Supplier. Zoll Medical Corp. [150032], Burlington, Mas-
sachusetts (USA); +1 (800) 348-9011, +1 (781) 229-0020;
www.zoll.com ◆
ECRI’s
User Experience Network
User Experience Network™ (UEN™) articles describe prob-
lems that ECRI believes are unlikely to pose a significant risk
of harm. Most describe common or nuisance problems that
can be corrected with an available modification or revised
operating or maintenance procedures. Typically, they in-
clude the hospital’s report and ECRI’s comment. When ap-
propriate, they also include the supplier’s response and
recommendations for corrective action.
HEALTH DEVICES 32 (5), May 2003
 Health Devices System
Objectives

To improve the effectiveness, safety, and

economy of health services by:
Providing independent, objective judg-
ment for selecting, purchasing, managing,
and using medical devices, equipment, and
systems.
Functioning as an information clearing-
house for hazards and deficiencies in
medical devices.
3. Encouraging the improvement of medical
devices through an informed marketplace.

A NONPROFIT AGENCY

www.ecri.org
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA
Telephone +1 (610) 825-6000 ■ Fax +1 (610) 834-1275 ■ E-mail healthdevices@ecri.org