IIIUSOO5591213A

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United States Patent (19) 11 Patent Number: 5,591,213
Morgan 45 Date of Patent: Jan. 7, 1997
(54) DEFIBRILLATOR SYSTEM CONDITION 4,852,572 8/1989 Nakahashi et al. .
INDCTATOR 4,957,109 9/1990 Groeger et al. .
5,078,134 1/1992 Heilman et al. .
(75 Inventor: Carlton B. Morgan, Bainbridge Island, 5,080,099 1/1992 Way et al. .
Wash 5,097,830 3/1992 Eikefjord et al. .
a- 5,099,844 3/1992 Faupel.
s 5,168,875 12/1992 Mitchiner.
73) Assignee: Heartstream, Inc., Seattle, Wash. 5,191,886 3/1993 Paeth et al. .
5,201,865 4/1993 Kuehn.
(21) Appl. No.: 532,863 5,249,573 10/1993 Fincke et al. ............................... 607/6.
(22 Filed: Sep. 21, 1995 FOREIGN PATENT DOCUMENTS
Related U.S. Application Data 93.16759 of 0000 WIPO ........................................ 60715
OTHER PUBLICATIONS
63 Continuation of Ser. No. 63,631, May 18, 1993, abandoned.
6 Product Brochure from ''Vivalink AED Automatic External
5) Int. C. ... AN Defibrillator system by survivalink Corporation, 2975
(52) U.S. Cl. - a rap - a a a a a a a a 607/5 84th Lane NE, Minneapolis, MN, 554.49, 4 pages total.
58 Field of Search ................................ 607/4-9, 27, 28, w
607/6, 63 Primary Examiner-William E. Kamm
Attorney, Agent, or Firm-Morrison & Foerster
(56) References Cited 57 ABSTRACT
U.S. PATENT DOCUMENTS A defibrillator and electrode system that gives the user a
4,164,946 8/1979 Langer. visible and/or audible indication of the condition of the
4,300,567 11/1981 Kolenik et al. . electrodes and other parts of the defibrillator system prior to
4,353,372 10/1982 Ayer deployment of the electrodes and use of the defibrillator. In
4,442,315 4/1984 Segawa a preferred embodiment of the method of this invention, a
4,488,555
4494.552
12/1984
1/1985
Imran
Heath
patient simulation and analyze circuit within the defibrillator
4.523595 6/1985 zibel periodically tests the condition of the system and provides
4539.995 9/1985 Segawa the user with a visual indication of the system's condition.
4,543,958 10/1985 Cartmell
4,583,549 4/1986 Manoli 32 Claims, 6 Drawing Sheets

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 5,591,213
1. 2
DEFBRILLATOR SYSTEM CONDITION operating condition of the defibrillator. Because the defibril
NDCTATOR lator electrodes are not part of the test circuit, however, the
simulation unit does not give any indication of electrode
This application is a continuation of application Ser. No. condition. Moreover, performing the test with patient simu
08/063,631, filed May 18, 1993, now abandoned. 5 lation units adds to the burden of highly paid medical
personnel, thereby raising the costs of the patient's care.
BACKGROUND OF THE INVENTION What is needed, therefore, is a defibrillation system condi
This invention relates generally to a method and apparatus tion indicator that tests the electrodes and perhaps other
parts of the defibrillator system automatically while the
for testing medical electrode systems and, in particular, to a O defibrillator is not in use.
mcthod and apparatus for testing the operating condition of This invention provides a defibrillator and electrode sys
defibrillators and defibrillator electrodes and for providing tem that gives the user a visible and/or audible indication of
the user with an indication of the system's condition. the condition of the electrodes and other parts of the defibril
Defibrillators apply voltage pulses to a patient's heart in lator system prior to deployment of the electrodes and use of
response to a life-threatening condition such as cardiac 5 the defibrillator. In a preferred embodiment of the method of
arrest. External defibrillators deliver the voltage pulse this invention, a patient simulation and analyzer circuit
through a pair of electrodes placed on the patient's chest or within the defibrillator periodically tests the condition of the
back by the attending medical personnel. The primary system and provides the user with a visual indication of the
components of a defibrillator system are the defibrillator, system's condition. One preferred embodiment of an elec
which provides the voltage pulse, and the electrodes, which 20 trode system useful for practicing this invention comprises
deliver the voltage pulse to the patient. a flexible substrate having a folded, undeployed position and
Prior art external defibrillator electrodes consist of a an extended, deployed position. The substrate supports an
paddle having an electrode face electrically connected to the electrode, an electrode tester conductive pad, and the elec
defibrillator by a cable. A conductive gel on the electrode trical connections between the defibrillator and the electrode
face lowers the electrical resistance between the electrode 25 and between the conductive pad and the patient simulation
and the patient. Disposable defibrillator electrodes are typi and testing circuit. In its undeployed position, the electrode
cally packaged with the gel pre-applied to the electrode face. contacts the conductive pad to complete a circuit from the
Adhesive holds the electrodes in place on the patient. With defibrillator, through the electrode to the patient simulation
standard reusable electrodes, on the other hand, the user circuit.
must apply the gel before placing the electrodes on the 30
In another preferred embodiment of an electrode system,
patient. Handles on the back side of the electrode paddles the flexible substrate has a rolled or wound undeployed
enable the user to place the electrodes at the desired sites on position and an unrolled or extended deployed position. The
the patient to hold the electrodes against the patient's skin. substrate supports a pair of electrodes, a pair of electrode
SUMMARY OF THE INVENTION 35
tester conductive pads, and the electrical connections
between these elements and the defibrillator and patient
One drawback of prior art defibrillator systems is the simulation circuits. In the substrate's undeployed position,
number of steps required to deploy the electrodes. Because the electrodes contact their respective conductive pads to
defibrillators are used primarily in emergency situations, complete a circuit from the defibrillator, through the elec
deployment and operation of defibrillator electrodes should 40
trodes to the patient simulation circuit.
be quick, easy and reliable. Prior art disposable defibrillator The invention is explained in more detail below with
electrodes, however, require the following steps for deploy reference to the drawings.
ment prior to delivery of the defibrillation pulse: connection
of a cable to the defibrillator; inevitably, untangling of the BRIEF DESCRIPTION OF THE DRAWENGS
cable; removal of the electrodes from their package; removal 45 FIG. 1 shows a block diagram of a defibrillator system
of the release liner covering the conductive gel over each according to this invention.
electrode face and any adhesive surrounding the electrode,
visual inspection of each electrode to determine whether it FIG. 2 is a schematic circuit diagram of the defibrillator
is usable; and application of the electrodes to the patient. system of this invention.
Each of these steps takes time, and time is of the essence 50 FIG. 3 is an elevational view of an electrode system
when trying to save a patient's life. according to a preferred embodiment of this invention.
Furthermore, if a visual inspection or actual defibrillation FIG. 4 is an exploded view of the electrode of FIG. 3.
attempt shows that either electrode is inoperative due to FIG. 5 is a side cross-sectional view of a defibrillator
deterioration of the conductive gel, a broken conductor in electrode system according to a preferred embodiment, prior
the cable, a broken connection between the cable and the 55 to deployment.
electrode, etc., then the deployment process must begin FIG. 6 is a cross-sectional view of a connector between an
again, wasting even more time. What is needed, therefore, is electrode system and an instrument.
a defibrillator system providing an indication of the condi FIG. 7 is a side cross-sectional view of the defibrillator
tion of the defibrillator and defibrillator electrodes before
deployment and placement on the patient. 60
electrode system of FIG. 5 with one electrode partially
deployed.
Patient simulation units are available to test the operation FIG. 8 is an elevational view of an alternative embodi
of external defibrillators. Typically, the defibrillator output
cable, i.e., the conductors leading to the electrodes, is ment of the electrode system of this invention.
connected to the simulation unit input. The defibrillator is FIG.9 is an exploded view of the electrode system of FIG.
then discharged as if the cable were attached to electrodes 65 8.
mounted on a patient. The simulation unit measures the FIG. 10 is a side cross-sectional view of the embodiment
defibrillator output pulse and gives an indication of the of FIG. 8, prior to deployment.
 5,591,213
3 4
FIG. 11 is a side cross-sectional view of the electrode electrode interface. In normal operation, the defibrillator
system of FIG. 10 with the electrodes partially deployed. should deliver a defibrillation pulse to the patient in response
to such an ECG signal.
DETAILED DESCRIPTION OF THE The analyzer monitors the output of the defibrillator
PREFERRED EMBODIMENT circuit logic to the test ECG signal. If the defibrillator circuit
logic fails to indicate that a defibrillation pulse is required,
FIG. 1 is a block diagram demonstrating the method and then the analyzer activates the indicator to show that the
apparatus of this invention as applied to a defibrillator defibrillator is not operable. Again, the indicator may be a
system. The defibrillator system 10 includes two or more visible indicator such as a light or a written message on a
electrodes 12 selectively connected to a standard defibrilla 10 display, an audible sound, or any other suitable means of
tor circuit 14 through an electrode interface 16. The defibril communicating an inoperable condition to the user.
lator circuit applies a therapeutic voltage or current pulse to The ECG test may also be used to determine the response
a patient through the electrodes under conditions controlled of the defibrillator circuit to a normal (non-fibrillating) ECG
by logic within or associated with the circuit. The defibril signal from a patient. As in the other tests, conductors
lator may also receive information regarding the patient's 15 leading from at least two electrodes are connected to the
defibrillator circuit via an electrode interface. The electrode
heart activity from the electrodes in the form of ECG surfaces themselves, i.e., the portion of the electrodes that
signals. The electrodes may be configured as described would be mounted on the patient during normal operation of
below or, alternatively, may be any defibrillator electrodes the defibrillator, are electrically connected to the patient
known in the art. simulator via the electrode interface. A signal Substantially
20
A patient simulator 18 is also selectively connected to the similar to an ECG signal derived from a patient with a
electrodes through interface 16. A defibrillator system ana normal ECG, i.e., not in ventricular fibrillation, is generated
lyzer 20 connected to the defibrillator circuit 14 and the by the patient simulator and delivered to the defibrillator
patient simulator 18 controls the operation of the defibril circuit via the electrodes and electrode interface. In normal
lator circuit 14 during a test procedure, receives test infor operation, the defibrillator should not deliver a defibrillation
mation through the patient simulator 18, analyzes the test 25 pulse to the patient in response to such an ECG signal.
information, and indicates the test results via indicator 22. A The analyzer monitors the output of the defibrillator
power Source 24 Supplies power to the system. circuit logic to the test ECG signal. If the defibrillator circuit
The operation of the system of FIG. 1 is as follows. The logic indicates that a defibrillation pulse is required, then the
system may be used to test the ability of the defibrillator analyzer activates the indicator to show that the defibrillator
circuit and electrodes to deliver a defibrillation pulse to a
30 is not operable. As with the other tests, the indicator may be
patient. Conductors leading from at least two electrodes are a visible indicator such as a light or a written message on a
connected to the defibrillator circuit via an electrode inter display, an audible sound, or any other suitable means of
communicating an inoperable condition to the user.
face. The electrode surfaces themselves, i.e., the portion of An indication that the defibrillator is not operable as a
the electrodes that would be mounted on the patient during 35 result of any of these tests could mean that there is a problem
normal operation of the defibrillator, are electrically con
nected to the patient simulator, also via the electrode inter with the electrodes, the conductive gel on the electrodes, the
face. A defibrillator test pulse is delivered from the defibril electrode interface, and/or the defibrillator circuit itself.
lator circuit to the electrodes, and the effect of the test pulse Therefore, if any test fails, the user may replace the elec
is measured at the patient simulator by the analyzer. The test trodes and/or the electrode interface and run the test again.
40 If the test indicates that the defibrillator system is now
pulse may be a voltage pulse of any magnitude, including
but not limited to voltage magnitudes used for actual operable, then the problem was in the electrodes and/or
electrode interface.
defibrillation. In that case, the analyzer will measure the
current flowing through the patient simulator. The test pulse The analyzer can also be used to monitor the power level
may also be a current pulse of any magnitude, in which case 45
of the battery in a battery-operated defibrillator. If the battery
the analyzer will measure the voltage across the patient level falls below a predetermined minimum, the analyzer
simulator. Other suitable tests will be apparent to those activates the indicator to show that the defibrillator is not
skilled in the art. operable because of low battery level.
If the current or voltage measured at the patient simulator The frequency of any of these tests may be chosen to meet
by the analyzer is below a predetermined threshold, the 50 the system's requirements. For example, the power required
analyzer activates the indicator to show that the defibrillator for the defibrillator pulse tests may be so high that the
is not operable. The indicator may be a visible indicator such frequency of this test must be limited in order to preserve
as a light or a written message on a display, an audible battery life in battery-operated defibrillators. At the other
sound, or any other suitable means of communicating an extreme, the analyzer could monitor battery level continu
inoperable condition to the user. 55
ously.
The system may also be used to test the response of the FIG. 2 is a circuit schematic showing one way of imple
logic portion of the defibrillator circuit to a signal originat menting the principal elements of the defibrillator system of
ing with the patient. As in the other test, conductors leading the preferred embodiment. The portion of the schematic
from at least two electrodes are connected to the defibrillator corresponding to the electrodes and electrode interface
circuit via an electrode interface. The electrode surfaces 60 blocks of FIG. 1 is enclosed by a dotted line 202 and is
themselves, i.e., the portion of the electrodes that would be referred to as the electrode apparatus or electrode system.
mounted on the patient during normal operation of the The electrode apparatus 202 includes a pair of electrodes
defibrillator, are electrically connected to the patient simu 204, conductive gel layers 206 covering the electrodes, and
lator, also via the electrode interface. A signal substantially a pair of test pads or contacts 208 shown here to be in
similar to an ECG signal derived from a patient in ventricu 65 electrical contact with gel layers 206.
lar fibrillation is generated by the patient simulator and Electrodes 204 connect to a standard defibrillator circuit
delivered to the defibrillator circuit via the electrodes and via conductors 210. In the circuit state shown here, the
 5,591,213
S 6
system is set to monitor patient ECG signals as if the 226. So long as the system passes the tests, the tests are
electrodes were attached to a patient. In this monitoring repeated periodically until the electrodes and their gel layers
state, switches 212 send the incoming signal from the are removed from test pads 208 as determined by a deploy
electrodes through a preamp 214 and an A/D converter 216 ment detector 240.
for prcprocessing before forwarding the signal to system FIGS. 3 and 4 show an electrode apparatus according to
microprocessor 218. Microprocessor monitors the received a preferred embodiment of this invention. As shown in
ECG signals and compares them to stored patterns or other FIGS. 3 and 4, the electrode apparatus 40 has a relatively
criteria to distinguish normal patient ECG patterns from stiff electrode body 45 attached to a flexible substrate 42
ECG patterns requiring action by the defibriliator system, as with a medical grade adhesive. In this embodiment, sub
discussed below. O strate 42 is a polymer such as polyester or Kapton, approxi
When configured as shown in FIG. 2, i.e., so that elec mately 3 mils thick. The length of substrate 42 depends on
trodes 204 are in electrical contact with test pads 208, the the requirements of the application. Electrode body 45 is
system is in test mode. The defibrillator system of this preferably made from a light-weight, closed-cell foam
invention has a patient simulation and test circuit 220 to approximately 25 mils thick.
monitor the condition and integrity of the system prior to 15 An electrode disk 44 is disposed within electrode body 45.
deployment of the electrodes and application of the elec Electrode disk 44 is preferably a circular piece of metal foil,
trodes to a patient. Periodically, microprocessor 218 sends a such as 3 mill tin, approximately 80 cm in area, attached to
series of test signals to D/A converter 222, which converts substrate 42 with a suitable medical grade adhesive. Elec
the signals to their analog equivalent and transmits the trode disk 44 is covered with a layer of conductive gel 51 in
signals to test pads 208 via conductors 224. Electrodes 204 20 a known manner. The thickness of gel layer 51 is 25 mils to
retrieve the test signals as if the test signals were actual make its top surface approximately even with the surround
patient ECG signals and sends the signals back to the ing electrode body surface. Medical grade adhesive is dis
microprocessor through the ECG monitor circuit described posed in adhesive area 52 on the top surface of electrode
above. body 45 surrounding the opening 53 for electrode disk 44.
Preferably, the test signals are of at least two types: 25
A first conductor 46 and a first electrical attachment pad
normal patient ECG waveforms, and ECG waveforms indi 48 are formed on, or attached to, flexible substrate 42.
cating a therapeutic pulse is required. The microprocessor Conductor 46 and electrical attachment pad 48 are prefer
analyzes the test signals as if they were actual patient ECG ably 3 mill tin foil formed integrally with electrode disk 44
and attached to substrate 42 with adhesive. A second con
signals and decides whether or not to apply a therapeutic ductor 43, a second electrical attachment pad 41 and a test
pulse to the electrodes. In ECG test mode, however, the 30 pad 38 are formed on, or attached to, substrate 42. Conduc
actual pulse is not generated or applied. Rather, the micro tor 43, attachment pad 41 and test pad 38 are also preferably
processor examines its own decision to determine if it was formed as an integral piece of metal foil attached to substrate
correct. If the outgoing ECG test signal from the micropro 42 with adhesive.
cessor to the D/A converter was a normal ECG waveform
and the microprocessor determines from the incoming test An insulating cover 47 is adhesively attached over sub
35 strate 42 and conductors 43 and 46. Cover 47 has a silicon
ECG signal that a therapeutic pulse is required, the system
is faulty, and the microprocessor indicates the fault on a fault release coating on its top side. Openings 49 and 37 are
indicator 226. Likewise, if the outgoing ECG test signal formed in cover 47 so that attachment pads 48 and 41,
from the microprocessor to the D/A converter was an ECG respectively, can make electrical contact with a connector, as
waveform indicating the need for atherapeutic pulse and the described below. An additional opening 39 is formed in
40 cover 47 so that test pad can make electrical contact with
microprocessor determines from the incoming test ECG
signal that a therapeutic pulse is not required, the system is electrode 44 through gel 51, also as described below.
faulty, and the microprocessor indicates the fault on a fault In FIGS. 5–7, a pair of the electrodes shown in FIGS. 3
indicator 226. If, on the other hand, the microprocessor and 4 are mounted in a retainer for use with a defibrillator
determines correctly the required course of action, the fault 45
system. FIG. 5 shows the electrodes in a predeployment
indicator is not activated. storage position. In this position, the flexible substrate 42 of
If the system passes the ECG tests, it then performs a each electrode is folded in an accordion fashion and placed
in retainer 60.
defibrillator test by generating a pulse through its normal
pulse generating circuitry and sending the pulse to the The portion of substrate 42 on which the attachment pads
electrodes 204. To initiate the pulse test, the microprocessor 50 41 and 48 are located extends into a retainer connector area
sends a charge command to a charge controller 230, which 70 for electrical attachment to a corresponding connector 72
begins charging capacitor 232 in a known manner from on the defibrillator 58. FIG. 6 shows the details of one
power supply 234. When the charge on capacitor 232 has embodiment of the connectors for attachment pads 48 on the
reached the required level (either the charge level required two electrode apparatuses. The same arrangement may be
for normal operation or some other test charge level), switch 55 used for attachment pads 41.
relay 228 moves switches 212 to their other position. This Metal crimps 74 at the end of substrate 42 make electrical
switch position permits the pulse circuit to discharge the contact with attachment pads 41 and 48. The crimps 74
capacitor to deliver a damped sinusoidal shock to the partially extend through openings 78 in the connector por
electrodes. tion 70 of retainer 60. When the retainer connector portion
The pulse transmitted by the electrodes through conduc 60 is inserted into the connector portion of the defibrillator 58,
tive gel layers 206 to test pads 208 is monitored by the test crimps 74 make electrical contact with defibrillator contacts
circuit 220 across a patient load simulator 236. The signal is 76. The resilient action of the crimps 74 also provide the
reduced by a divider circuit and sent to microprocessor 218 mechanical attachment of retainer 60 to defibrillator 58. The
via A/D converter 238. If the pulse received by the micro contacts 76 for each electrode and for each test pad are
processor does not meet predetermined criteria (such as 65 connected to the defibrillator electronics in a known manner.
voltage levels and signal waveform shape), the micropro The test pads 38, their associated conductors 43, their
cessor indicates a system fault by activating fault indicator attachment pads 41, and the retainer connector 70 serve as
 5,591,213
7 8
the interface between the electrodes and a patient simulator is preferably 80 cm'. A layer of conductive gel 151 covers
circuit within defibrillator 58 during the defibrillator system each electrode. The thickness of the conductive gel layer is
tests described above. An indicator 59 such as a light or an preferably 25 mils.
audible annunciator is provided to inform the user of test An insulating cover 147 is attached to the top side of
results. substrate 142 with medical grade adhesive. Cover has open
Likewise, the conductors 46 and attachment pads 48 on ings 180 for the electrodes and openings 149 for the attach
the substrates are the interface between the electrodes and ment pads. Openings 180 have diameters slightly smaller
the defibrillator for delivery of the defibrillating voltage than the diameters of their respective electrodes, and open
pulse and/or for monitoring of the electrical activity of the ings 149 have diameters slightly smaller than their respec
patient's heart during normal operation of the defibrillator. 10 tive attachment pads. Medical grade adhesive covers all of
The positions of the electrode apparatus during the two the top surface of cover 147 except for handle area 156 and
operational modes will be explained with reference to FIGS. connector area 157 for attachment of the electrode apparatus
5 and 7.
to a patient.
In the folded position shown in FIG. 5, the conductive gel FIGS. 10 and 11 show the electrode apparatus of this
51 covering the electrode disk 44 of each electrode appara 15 embodiment mounted in a retainer. As seen in FIG. 10, prior
tus lies in electrical contact with its respective test pad 38. to deployment, the electrode apparatus is wound around a
This contact closes the circuit going from one electrode spool-shaped retainer 160 mounted on top of a defibrillator
through the patient simulation circuit to the other electrode 158. The portion of the electrode apparatus on which the
so that the patient simulation tests can be performed. attachment pads 141 and 148 are located extend into the
Also, in the folded position shown in FIG. 5, the adhesive 20 center of the retainer spool where they make electrical
Surrounding the electrode disk lies against an area 54 on the connection with conductors (not shown) that connect to the
top surface of substrate 42. The top surface of substrate 42 defibrillator connector 172. The metal crimps shown in FIG.
is coated with a suitable release coating such as silicon in at 6 may be used for this purpose. A protective cover 164 may
least release area 54. The release coating enables the adhe be kept over retainer spool 160 until the electrodes are to be
sive to peel away from substrate 42 during deployment of 25 deployed.
the electrode, as discussed below. The covering action of the In the undeployed state shown in FIG. 10, the conductive
substrate over the conductive get also helps keep the con gel layers 151 and the adhesive coating on cover layer 147
ductive gel from drying out during storage. A handle 56 face the inward toward the center of the retainer'spool, and
attached to the back side of electrode body 45 lies in position the release coating on the underside of backing layer 182
in which it can be grasped by a user during deployment of 30
faces outward from the center. Thus, when the electrode
the electrodes.
apparatus is wound about itself, the conductive gel layers
FIG. 7 demonstrates deployment of the electrodes. As 151 and the adhesive coating on the cover layer lie against
shown in FIG. 7, the user pulls electrode body 45 out of the silicon release coating of the backing layer 182. Also, the
retainer 60 by grasping handle 56. As it moves out of the conductive gel layers 151 of each electrode lie in electrical
retainer, the electrode disk 44 and its conductive gel layer 51 35
contact against their respective test pads 138, as shown. This
peel away from Substrate surface 42. Movement of the contact closes the circuit going from one electrode through
conductive gel layers 51 of the electrodes away from their the patient simulation circuit to the other electrode so that
respective test pads 38 breaks the circuit through the patient the patient simulation tests can be performed. An indicator
simulator. After removal from the retainer, the electrodes 159 such as a light or an audible annunciator is provided to
may be placed on a patient and used for monitoring the 40
inform the user of test results.
patient's heart activity and for applying therapeutic electri To deploy the electrode apparatus of this embodiment, the
cal pulses in the usual manner. protective cover 164 is removed, and the electrode apparatus
FIGS. 8-11 show an alternative embodiment of this is unwound from retainer spool 160 by pulling on handle or
invention. As shown in FIGS. 8 and 9, the electrode appa 45 tab 156, as shown in FIG. 11. The release coating on backing
ratus 140 has a flexible body or substrate 2, preferably layer 182 permits the conductive gel layers 151 and the
formed from /16" closed cell foam. A backing layer 182 is adhesive on cover layer 147 to peel away. Movement of the
attached to the underside of substrate 142 with a medical conductive gel layers 151 of the electrodes away from their
grade adhesive. Backing layer 182 may be formed from respective test pads 138 breaks the circuit through the
Tyvek or any other suitable material. 50 patient simulator. The electrode apparatus is then applied to
The underside of backing layer 182 is coated with a the patient and used for monitoring the patient's heart
silicon release material. A pair of test pads 138 are adhe activity and for applying therapeutic electrical pulses in the
sively attached to the top of backing layer 182 over a pair of usual manner.
openings 184 whose diameters are slightly smaller than the The electrode apparatus and spool retainer remain
diameters of test pads 138. Openings 184 provide access to 55 attached to the defibrillator during use. The conductors 146
test pads 138 from the underside of backing layer 182. and attachment pads 148 provide the electrical connection
Conductors 143 lead from test pads 138 to attachment between the electrodes 144 and the defibrillator for delivery
pads 141. Openings 186 beneath attachment pads 141 have of the defibrillating voltage pulse and/or for monitoring of
diameters slightly smaller than the diameters of attachment the electrical activity of the patient’s heart. After use, the
pads 141. Each set of test pad, conductor and attachment pad 60 retainer spool and the electrode apparatus it houses can be
is preferably formed from a single piece of tin metal foil 3 discarded and replaced with a new electrode set.
mils thick. Modifications may be made to the described embodiments
A pair of electrodes 144 are adhesively attached to the top without departing from the scope of the invention. For
of substrate 142. Conductors 146 lead from electrodes 144 example, other electrode configurations may be used with
to attachment pads 148. Each set of electrode, conductor and 65 the test apparatus of this invention so long as an appropriate
attachment pad is preferably formed from a single piece of electrode interface is provided. When selecting electrode
tin metal foil 3 mils thick. The surface area of each electrode materials, it should be remembered that repeated tests could
 5,591,213
10
cause corrosion of the electrodes and/or test pads if the tests 13. The defibrillator system of claim 8 wherein the test
are not charge-balanced. In addition, while in the preferred signal analyzer comprises a microprocessor.
cmbodiment the defibrillator runs the electrode integrity 14. The defibrillator system of claim 13 wherein the test
tests, it should be understood that a separate test unit may be signal analyzer further comprises an A/D convertor.
used instead. The electrodes would then have to be discon 15. A defibrillator system comprising:
nected from the test unit and connected to a defibrillator defibrillator, the defibrillator comprising a defibrillator
before actual use. Also, while this invention has been circuit and an electrode interface, the defibrillator cir
described in the context of defibrillators and defibrillator cuit comprising an energy source, the electrode inter
electrodes, it should be understood that the invention applies face comprising conductors in electrical communica
to medical electrodes used with other instruments, such as 10 tion with the energy source;
ECG monitors. means for periodically delivering a test signal through the
Other modifications will be apparent to those skilled in conductors;
the art. a patient simulator communicating with the conductors;
What is claimed is:
1. A defibrillator system comprising: 15 a test signal analyzer communicating with the conductors
a defibrillator, the defibrillator comprising a defibrillator and the patient simulator; and
circuit and an electrode interface, the defibrillator cir a fault indicator communicating with the test signal
cuit comprising an energy source, the electrode inter analyzer,
face comprising conductors in electrical communica wherein the test signal is an ECG signal pattern.
tion with the energy source; 20 16. A defibrillator system comprising:
means for periodically operating the energy source to a defibrillator, the defibrillator comprising a defibrillator
discharge a test pulse through the conductors; circuit and an electrode interface, the defibrillator cir
a patient simulator communicating with the conductors; cuit comprising an energy source, the electrode inter
a test pulse analyzer communicating with the conductors face comprising conductors in electrical communica
25 tion with the energy source;
and the patient simulator, and means for periodically delivering a test ECG signal
a fault indicator communicating with the test pulse ana through the conductors;
lyZer.
2. The defibrillator system of claim 1 further comprising means for periodically delivering a test pulse through the
electrodes attached to the conductors. 30 conductors;
3. The defibrillator system of claim 1 wherein the means a patient simulator communicating with the conductors;
for periodically operating comprises a microprocessor. an analyzer communicating with the conductors and the
4. The defibrillator system of claim 1 wherein test pulse patient simulator; and
analyzer comprises a microprocessor. a fault indicator communicating with the analyzer.
5. The defibrillator system of claim 4 wherein the test 35 17. A test system for a defibrillator, the system compris
pulse analyzer further comprises means for sensing an ing:
electrical parameter. an energy SOurce;
6. The defibrillator system of claim 1 wherein the fault conductors in electrical communication with the energy
indicator comprises a visual display. SOurce,
7. The defibrillator system of claim 6 wherein the visual 40
display comprises a light. means for periodically operating the energy source to
8. A defibrillator system comprising: discharge a test pulse through the conductors;
a defibrillator, the defibrillator comprising a defibrillator a patient simulator communicating with the conductors;
circuit and an electrode interface, the defibrillator cir a test pulse analyzer communicating with the conductors
cuit comprising an energy source, the electrode inter 45 and the patient simulator; and
face comprising conductors in electrical communica a fault indicator communicating with the test pulse ana
tion with the energy source; lyzer.
means for periodically delivering a test signal through the 18. The system of claim 17 further comprising electrodes
conductors; attached to the conductors.
50
a patient simulator communicating with the conductors; 19. The system of claim 17 wherein the means for
a test signal analyzer communicating with the conductors periodically operating comprises a microprocessor.
and the patient simulator, and 20. The system of claim 17 wherein test pulse analyzer
comprises a microprocessor.
a fault indicator communicating with the test signal 21. The system of claim 20 wherein the test pulse analyzer
analyzer. 55
further comprises means for sensing an electrical parameter.
9. The defibrillator system of claim 8 further comprising 22. The system of claim 17 wherein the fault indicator
electrodes attached to the conductors. comprises a visual display.
10. The defibrillator system of claim 8 wherein the means 23. The system of claim 22 wherein the visual display
for periodically delivering a test signal comprises means for comprises a light.
operating the energy source to discharge a test pulse through 60
24. A test system for a defibrillator, the system compris
the conductors. ing:
11. The defibrillator system of claim 8 wherein the means an energy source;
for periodically delivering a test signal comprises a micro
processor. conductors in electrical communication with the energy
12. The defibrillator system of claim 11 wherein the 65 Source,
means for periodically delivering a test signal further com means for periodically delivering a test signal through the
prises a D/A convertor. conductors;
 5,591,213
11 12
a patient simulator communicating with the conductors; 31. The system of claim 30 wherein the test signal
a test signal analyzer communicating with the conductors analyzer further comprises an A/D convertor.
and the patient simulator, and 32. A test system for a defibrillator, the system compris
a fault indicator communicating with the test signal 5
ing:
analyZer.
25. The system of claim 24 further comprising electrodes an energy source,
attached to the conductors. conductors in electrical communication with the energy
26. The system of claim 24 wherein the means for SOurce,
periodically delivering a test signal comprises means for
operating the energy source to discharge a test pulse through 10 means for periodically delivering a test ECG signal
the conductors. through the conductors;
27. The system of claim 24 wherein the test signal is an means for periodically delivering a test pulse through the
ECG signal pattern. conductors;
28. The system of claim 24 wherein the means for 15
periodically delivering a test signal comprises a micropro a patient simulator communicating with the conductors;
CESSO. an analyZer communicating with the conductors and the
29. The system of claim 28 wherein the means for patient simulator, and
periodically delivering a test signal further comprises a D/A
COWeO. a fault indicator communicating with the analyzer.
30. The system of claim 24 wherein the test signal 20
analyzer comprises a microprocessor.
 UNITED STATES PATENT AND TRADEMARK OFFICE
CERTFCATE OF CORRECTION

PATENT NO. : 5,591,213

DATED 7 Jan 1997
INVENTOR(S): Carlton B. Morgan

It is certified that error appears in the above-identified patent and that said Letters Patent
is hereby corrected as shown below:
On The Cover Page
At (54) "INDICTATOR” should be -INDICATOR-.
At (56 add to U.S. documents -5,184,620 2/1993 Cudahy et al. -
At (57), line 6 "analyze circuit' should be -analyzer circuit-.

In Column 1, line 2, 'INDICTATOR' should be -INDICATOR -.

At column 7, line 27, "get" should be -gel-.
In Column 7, line 46, "substrate 2' should be - substrate 142-.
In Column 8, line 5, "Cover has' should be -Cover 147 has -.
In Column 10, line 6 (claim 15), "defibrillator, the defibrillator comprising a
defibrillator' should be -a defibrillator, the defibrillator comprising a defibrillator -.
Signed and Sealed this
Nineteenth Day of August, 1997

Attest: (a (4-4-
BRUCE LEHMAN

Attesting Officer Commissioner of Patents and Trademarks