US20100063558A9 - Easy-to-use electrode and package - Google Patents
Easy-to-use electrode and package Download PDFInfo
- Publication number
- US20100063558A9 US20100063558A9 US11/429,513 US42951306A US2010063558A9 US 20100063558 A9 US20100063558 A9 US 20100063558A9 US 42951306 A US42951306 A US 42951306A US 2010063558 A9 US2010063558 A9 US 2010063558A9
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- Prior art keywords
- pouch
- handle
- electrode
- patient
- notch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3968—Constructional arrangements, e.g. casings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/046—Specially adapted for shock therapy, e.g. defibrillation
Abstract
Description
- This application is a continuation of and claims priority to Ser. No. 10/008,243, filed Nov. 7, 2001, the entire content of which is incorporated herein by reference.
- The invention relates to medical devices for treating cardiac conditions, and more particularly, to external defibrillators.
- Cardiac arrest is a life-threatening medical condition that may be treated with external defibrillation. External defibrillation includes applying electrodes to the patient's chest and delivering an electric shock to the patient to depolarize the patient's heart and restore normal sinus rhythm. The chances that a patient's heart can be successfully defibrillated increase significantly if a defibrillation pulse is applied quickly.
- Until recently, individuals such as paramedics, emergency medical technicians, police officers and others trained in defibrillation techniques used defibrillators, but the general public did not. In some cases, the patient's need is urgent and the patient cannot wait for trained personnel to arrive. In recognition of the need for prompt treatment, automated external defibrillators (AED's) are becoming more commonplace, and are available in venues such as airports, health clubs and auditoriums.
- When an AED is used to treat a patient, much of the treatment is performed by the AED rather than the person who operates the AED. In general, the AED automatically measures the patient's cardiac signals, assesses whether a shock is indicated and charges a storage element in preparation for giving the shock. When a shock is indicated, the AED may cue the operator to administer the shock, or the AED may administer the shock automatically. In addition, many AED's include visual displays, voice instructions and other audible messages that tell the operator about the status of the defibrillator.
- Placement of defibrillation electrodes on the patient's chest, however, cannot be performed by the AED. In many AED's, the electrodes are packaged in a sealed pouch. The operator must open the pouch, retrieve the electrodes and place the electrodes in the correct positions on the patient's chest. In many cases, a minimally trained operator, properly instructed, can place the electrodes on the patient's chest in the correct positions. Without instruction, the operator could put one or both electrodes in an incorrect anatomical placement.
- The invention is directed to making an AED more effective when used by an operator, such as a minimally trained operator who operates the AED infrequently. Because time is at a premium, an operator should be able to understand how to use an AED with as little instruction as possible. In particular, an operator should be able to find the electrode pouch immediately, open the pouch in moments, and to place the electrodes in the correct positions quickly and accurately. The invention is directed toward helping an operator apply defibrillation therapy to a patient, when time is of the essence.
- In one embodiment, the invention presents a medical device, such as a defibrillator or defibrillator-monitor, with a pouch containing a defibrillation electrode fastened to the medical device. The pouch may be fastened to the medical device with an anchor. The pouch may further include a handle. By pulling the handle, the operator easily opens the pouch to retrieve the electrodes. Instructive pictures and other visual cues may further help the operator understand how to open the pouch and how to place the electrodes.
- In another embodiment, the invention presents a pouch containing a defibrillation electrode. The pouch includes a handle that an operator pulls, causing the pouch to open. The handle may have, for example, a ring shape and may be a distinctive color. A notch in the pouch may help the operator to tear open the pouch. The invention also encompasses a method of making such a pouch.
- In a further embodiment, the invention presents defibrillation electrodes with instructive pictures. The instructive pictures show a human figure with electrode symbols , to instruct the operator as to where and how to place the electrodes. The instructional picture on an electrode is printed at an angle. When the operator applies the defibrillation electrode to the patient, with the head of the patient and the head of the human figure in the same direction, the defibrillation electrode will be oriented at a proper angle.
- Many of the features of the invention are directed to saving time, and thereby increasing the patient's chances of survival. Although the invention is advantageous to those with experience with AED's, the invention is particularly of benefit to operators who have little formal training in the use of the AED or may have had training a long time ago. The invention provides visual cues that show the operator what to do. The visual cues are easy to understand and the actions to be performed are easy to do. By following the visual cues, the operator can quickly retrieve the packaged electrodes and place the electrodes at the proper locations on the patient.
- The above summary of the invention is not intended to describe every embodiment of the invention. The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
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FIG. 1 is a perspective view of an AED. -
FIG. 2 is a view of a pouch and an electrode assembly. -
FIG. 3A is a plan view of the obverse face of the pouch. -
FIG. 3B is an instructive picture showing a technique for opening the pouch. -
FIG. 4 is a plan view of an electrode assembly. -
FIG. 1 shows an example medical device that illustrates an embodiment of the invention. AED 10 includescover 12, which is hingedly coupled todefibrillator case 14.Defibrillator case 14 includes circuitry (not shown inFIG. 1 ) that performs functions such as making measurements, processing cardiac signals, storing energy for delivery as a defibrillation pulse and regulating the delivery of the defibrillation pulse.Defibrillator case 14 also houses a power supply such as a battery (not shown inFIG. 1 ). In addition,defibrillator case 14 may include circuitry that controls automated voice instructions, other audible messages and readiness indicators and othervisual indicators 38. -
Pouch 16 rests atopdefibrillator case 14. In one example,pouch 16 is about 7.3 in (18.5 cm) wide and 5.7 in (14.5 cm) long.Pouch 16 containselectrodes 74 and 76 (not shown inFIG. 1 ) to be placed upon the chest of the patient.Electrodes defibrillator case 14 viainsulated lead wires 22 andconnector 18. Leadwires 22 extend fromelectrodes entry point 48 inpouch 16, and are coupled toconnector 18.Connector 18 mates toreceptacle 20 indefibrillator case 14. Signals detected byelectrodes defibrillator case 14 viainsulated lead wires 22 andconnector 18. Similarly, defibrillation pulses are supplied from energy storage circuitry indefibrillator case 14 toelectrodes connector 18 and insulatedlead wires 22. -
Pouch 16 is fastened todefibrillator case 14. In the example embodiment shown inFIG. 1 ,cylindrical slot 32 indefibrillator case 14 receivescylindrical member 30.Cylindrical member 30 is a component ofpouch 16 located near upperleft corner 42 ofpouch 16. As will be shown below,cylindrical member 30, when engaged withcylindrical slot 32, serves as an anchor forpouch 16. The placement ofcylindrical slot 32 andcylindrical member 30 contribute to makingpouch 16 easy to open. In addition, the placement ofcylindrical slot 32 andcylindrical member 30 assure thatpouch 16 is fastened todefibrillator case 14 withobverse face 44 ofpouch 16 exposed. -
Defibrillator case 14 includeslip 26.Bottom edge 40 ofpouch 16 is tucked beneathlip 26. Together,cylindrical slot 32 andlip 26 help keeppouch 16 in place. -
Electrodes pouch 16 are not permanently coupled todefibrillation case 14, and it is advantageous forelectrodes pouch 16 to be removable.Pouch 16 typically has a shelf life, for example, andelectrodes pouch 16 are replaced when the shelf life expires. In addition,electrodes pouch 16 are replaced afterpouch 16 has been opened. - Accordingly,
connector 18 may be decoupled fromreceptacle 20 by pullingconnector 18 fromreceptacle 20.Pouch 16 may be decoupled fromdefibrillator case 14 by slidingcylindrical member 30 out ofcylindrical slot 32 and, if necessary, by pullingpouch 16 from underlip 26. Installing new electrodes andpouch 16 comprises obtaining a fresh,unopened pouch 16, insertingcylindrical member 30 intocylindrical slot 32, tuckinglower edge 40 ofpouch 16 beneathlip 26 and insertingconnector 18 intoreceptacle 20. - An operator desiring to use
AED 10 opens cover 12 by depressingbutton 36 ondefibrillator case 14, which releaseslatch 34. Upon openingAED 10, an operator is immediately presented with theobverse face 44 ofpouch 16. Obverse face 44 ofpouch 16 includesinstructive pictures 28 showing techniques for openingpouch 16 and placing the electrodes on the patient.FIGS. 3A and 3B present examples ofinstructive pictures 28, and will be described in more detail below. -
Electrodes pouch 16 to protectelectrodes Electrodes electrodes electrodes Pouch 16 may be, for example, an airtight foil bag that prevents the hydrogel from drying out and losing its desirable properties. Accordingly, the operator must openpouch 16 to obtain access toelectrodes -
Pouch 16 includeslarge handle 24 near upperleft corner 42 ofpouch 16.Handle 24 may be composed of a brightly colored plastic, such as red plastic, so thathandle 24 is especially prominent.Handle 24 may be a ring-type handle as shown inFIG. 1 , makinghandle 24 easy to clutch and pull. -
Handle 24 is oriented at an angle relative todefibrillator case 14, suggesting to the operator that handle 24 is to be pulled toward himself and to the right. In addition, handle 24 may includedirectional arrows 50 that further show the operator the direction in which to pullhandle 24. As the operator pulls handle 24,cylindrical member 30 incylindrical slot 32 anchors upperleft corner 42 ofpouch 16 in place.Cylindrical member 30 can be removed fromcylindrical slot 32 by pullingcylindrical member 30 to the left. However, pullinghandle 24 to openpouch 16 will not dislodgecylindrical member 30 fromcylindrical slot 32. - The operator tears
pouch 16 open by pullinghandle 24.Pouch 16 tears beginning at notch 60 (not shown inFIG. 1 ), and continues to tear alongtear strip 46. Tearstrip 46 prevents the tear from cutting acrosspouch 16, potentiallydamaging electrodes tear strip 46 comprises tape with embedded fibers that guide the tear. The tape may be included on both theobverse side 44 and the reverse side ofpouch 16. - As
pouch 16 tears alongtear strip 46, pouch opens, makingelectrodes Pouch 16 may be torn into two pieces. The smaller piece is the small strip that remains fastened todefibrillator case 14 bycylindrical member 30. Leadwires 22, which are secured at sealedentry point 48, remain anchored todefibrillator case 14, preventing the operator from inadvertently pullingconnector 18 fromreceptacle 20. The larger piece ofpouch 16 slips easily fromlip 26. The operator may extractelectrodes electrodes handle 24. The operator retrieveselectrodes electrodes -
FIG. 2 showspouch 16 andelectrode assembly 70, which includes a right electrode 74 (also called an anterior electrode) and a left electrode 76 (not shown inFIG. 2 ) (also called a lateral electrode).Bottom edge 40 ofpouch 16 has been removed for purposes of illustration, andFIG. 2 is not intended to demonstrate howelectrode assembly 70 is to be removed frompouch 16. - As shown in
FIG. 2 and as will be shown in more detail inFIG. 4 ,electrode assembly 70 includesright electrode 74 and leftelectrode 76 affixed toliner 72.Liner 72 is folded to allowelectrodes pouch 16. The usefulness ofliner 72 will be discussed in more detail in connection withFIG. 4 . -
FIG. 2 further illustrates that a length of insulatedlead wires 22 is coiled insidepouch 16. In one embodiment, about 48 inches (122 cm) of the length of insulatedlead wires 22 extends fromelectrodes entry point 48. -
FIG. 2 showscylindrical member 30 and handle 24.Handle 24 has been flipped upward to showobverse face 44 ofpouch 16.Cylindrical member 30 and handle 24 are securely bonded to the foil portion ofpouch 16, e.g., by ultrasonic welding.Notch 60 is betweenhandle 24 andcylindrical member 30.Notch 60 provides a starting point for tearing ofpouch 16. When the operator pulls handle 24 as illustrated inFIG. 3B ,pouch 16 tears beginning atnotch 60. The portion ofpouch 16 to the left side ofnotch 60 is held in place bycylindrical member 30 in cylindrical slot 32 (not shown inFIG. 2 ), and the portion to the right side ofnotch 60 is drawn withhandle 24.Pouch 16 tears alongtear strip 46. - Obverse face 44 of
pouch 16 includesinstructive pictures 28.Instructive picture 62 shows the operator how to openpouch 16.Instructive picture 62 is positioned onobverse face 44 to be visible through the opening inhandle 24.Instructive picture 64 indicates thatpouch 16 contains electrodes and further shows the operator where to place the electrodes on the patient.Instructive pictures FIGS. 3A and 3B . In addition,directional arrows 50 onhandle 24 may further inform the operator how to pullhandle 24. -
FIG. 3A showsobverse face 44 ofpouch 16.Handle 24 andcylindrical member 30 have been removed.Tab 98 provides a site for securing,cylindrical member 30 to the left ofnotch 60 andtab 96 provides a site for securinghandle 24 to the right ofnotch 60. - Obverse face 44 of
pouch 16 includesinstructive pictures Instructive pictures pouch 16 in many ways, such as by four-color printing or embossing.Instructive pictures pouch 16. -
Instructive picture 64 depicts bare-chested humanfigure 90 , which represents the patient.Right electrode symbol 92 is shown placed on the upper right side of the chest offigure 90 .Left electrode symbol 94 is shown placed on the lower left side of the chest offigure 90 .Left electrode symbol 94 is further shown oriented at an angle α, relative to the direction of the head offigure 90 .Left electrode symbol 94 tells the operator that leftelectrode 76 should be placed at a small angle. As will be described below in connection withFIG. 4 , the angle shown ininstructive picture 130 onleft electrode 76 assists the operator in making the proper anatomical placement ofleft electrode 130. -
Electrode symbols electrodes electrode symbols -
FIG. 3B showsinstructive picture 62 in more detail.Instructive picture 62 shows the operator how to openpouch 16, represented bypouch symbol 112. In particular,instructive picture 62 includes ahandle symbol 106, and showsright hand 100 clutchinghandle 106 by reaching throughopening 108.Handle symbol 106 is color-coded to match the color ofhandle 24.Left hand 102 is shown holding downpouch 112.Instructive picture 62 further includesdirectional arrows 104 that show the operator the direction in which to pullhandle 24.Instructive picture 62 also shows the tearing ofpouch 112 andfurther shows path 110 along which tearing occurs. -
Instructive picture 62 instructs the operator to clutch handle 24 with his right hand.Instructive picture 62 also instructs the operator to holddefibrillator case 14 and the left edge ofpouch 16 with his left hand. The left hand provides leverage for openingpouch 16 and prevents the operator from pullingAED 10 when pullinghandle 24. Further,instructive picture 62 instructs the operator to pullhandle 24 firmly with the right hand, and in particular, to pull toward the operator and to the right, thereby tearingopen pouch 16. The orientation ofhandle 24 anddirectional arrows 50, as shown inFIGS. 1 and 2 , further inform the operator as to pull toward himself and to the right. By applying the techniques illustrated ininstructive picture 62, the operator openspouch 16 and obtains access toelectrode assembly 70, includingdefibrillation electrodes -
FIG. 4 showselectrode assembly 70, includingelectrodes Electrodes FIG. 4 ) are electrically coupled to leadwires 22.Right electrode 74 is color-coded to matchright electrode symbol 92, and leftelectrode 76 is color-coded to matchleft electrode symbol 94.Electrodes liner 72. - As noted above, the tin foil plates of
electrodes electrodes Electrodes Liner 72 preventselectrodes liner 72 fromelectrodes electrodes -
Electrode assembly 70 includes features to instruct the operator to removeelectrodes liner 72.Right electrode 74 includestab 120 with peeled-corner icon 122, instructing the operator to peelright electrode 74 fromliner 72. Similarly, leftelectrode 76 includestab 124 with peeled-corner icon 126 that instructs the operator to peelleft electrode 76 fromliner 72. Peeled-corner icons resemble a flipped-up corner oftabs electrodes liner 72. - Further, a
single liner 72 adheres to bothelectrodes liner 72 helps the operator understand thatliner 72 needs to be removed from bothelectrodes electrodes instructive pictures electrodes Instructive pictures instructive picture 64 onobverse face 44 ofpouch 16. Unlikeinstructive picture 64, which includes symbols for right and leftelectrodes instructive picture 128 includes onlyright electrode symbol 92 andinstructive picture 130 includes only leftelectrode symbol 94.Instructive pictures electrodes - It is immediately apparent to the operator that
electrodes electrodes liner 72 is not perforated and cannot be easily torn, it is evident to the operator thatelectrodes liner 72.Tabs corner icons electrodes liner 72. - Moreover,
liner 72 may be color-coded so as not to match any symbol ininstructive pictures Liner 72 may be blue, for example, andinstructive pictures blue liner 72, and sees no blue items ininstructive pictures liner 72 is to be removed and discarded. Color-coding also provides contrast, so that the operator understands thatliner 72 is distinct fromelectrodes -
Instructive picture 128 shows the correct placement ofright electrode 74. In particular,instructive picture 128 shows right electrode symbol placed upon the right side of the chest of humanfigure 90 , above and slightly to the left of the right nipple. Whenright electrode 74 is correctly placed,instructive picture 128 appears properly oriented, in that the head of figure 90 is oriented in the same direction as the head of the patient. - On the face of
left electrode 76, figure 90 ininstructive picture 130 is oriented at an angle α, as compared with the orientation of figure 90 ininstructive picture 128. AsFIG. 4 illustrates, the same angle α describes the orientation ofleft electrode symbol 94 relative to the direction of the head of figure 90 ininstructive pictures - Orientation of figure 90 in
instructive picture 130 at angle α demonstrates to the operator the proper placement ofleft electrode 76. In particular, when the operator correctly places leftelectrode 76,instructive picture 130 appears to the operator to be properly oriented, with the head of figure 90 oriented in the same direction as the head of the patient. - To place left
electrode 76 in the correct orientation, the operator turnsleft electrode 76 by approximately angle α prior to placement. In particular, the operator orients the head of figure 90 in the same direction as the head of the patient. In doing so, the operator places leftelectrode 76 in the orientation resembling the orientation ofleft electrode symbol 94 ininstructive picture 64. - The angled placement of
left electrode 76 may provide therapeutic benefit to the patient. In defibrillation,AED 10 supplies current that travels betweenelectrode Right electrode 74 and leftelectrode 76 are placed on opposite ends of this line, withleft electrode 76 positioned on the lower chest of the patient and somewhat on the side of the chest. Angled placement ofleft electrode 76 is more likely to produce proper anatomical placement, and is therefore more likely to result in proper current flow. - Once the operator has placed the electrodes on the chest of the patient,
AED 10 may automatically sense the presence of a conductive path through the body of the patient.AED 10 may evaluate the heart rhythm of the patient and may deliver a shock when a shockable rhythm is detected. In some AED's, the AED administers the shock automatically, and in others, the AED cues the operator to press a button to administer the shock. -
AED 10 cannot evaluate the heart rhythm until thedefibrillation electrodes - The invention assists the operator in performing these tasks in several respects. The invention provides for easy-opening
pouch 16, which tears open upon the pull ofhandle 24. Several visual cues prompt the operator to pullhandle 24.Handle 24 is a prominent feature ofpouch 16, may be brightly colored and may includedirectional arrows 50. In addition,instructive picture 62 shows the operator thatpouch 16 is to be opened, and further shows the operator how to perform this task. An anchor such ascylindrical member 30 holds a corner ofpouch 16 in place, making it easier for the operator to openpouch 16 by pullinghandle 24. - Once
pouch 16 is open, the operator extractselectrode assembly 70, includingdefibrillation electrodes liner 72. Several visual cues prompt the operator to removeliner 72 andplace electrodes Tabs corner icons electrodes liner 72.Instructive picture 64 onpouch 16,instructive picture 128 onright electrode 74 andinstructive picture 130 onleft electrode 76 show the operator where to placeelectrodes electrodes electrode symbols instructive pictures right electrode 74 fromleft electrode 76 and helps theoperator place electrodes instructive picture 130 further helps the operator position leftelectrode 76 properly. - In summary, there are several visual cues that show the operator what needs to be done. Many visual cues, such as
directional arrows 50 anddirectional arrows 104, reinforce the same actions. Commonly known and understood symbols such as human figures and arrows makeinstructive pictures AED 10. Instead of spending time reading detailed directions, the operator follows the visual cues. In addition, becauseinstructive pictures - As a result, the operator places
electrodes electrodes AED 10 will provide successful treatment for the patient. - Various embodiments of the invention have been described. These embodiments are illustrative of the practice of the invention. Various modifications may be made without departing from the scope of the claims. For example, the handle may be constructed other than shown in
FIGS. 1 and 2 . The handle may, for example, be formed from the same foil material as the pouch. A handle may be presented in a form other than a ring, such as a cord, a knob or a lever. - Many different forms of anchors are also possible, such as a clip, an adhesive or a hook. Although the embodiments described above show an anchor in the form of a
cylindrical member 30 that mates withcylindrical slot 32, an anchor may include other forms of mating members onpouch 16 anddefibrillator case 14. In addition, the invention encompasses embodiments in which the anchor is a component ofdefibrillator case 14, with no mating member onpouch 16.Defibrillator case 14 may include, for example, a clasp that fastenspouch 16 tocase 14. Similarly, the invention encompasses embodiments in which the anchor is a component ofpouch 16, with no mating member ondefibrillator case 14. - Modifications may also be made to the electrode assembly or the electrodes without departing from the scope of the claims. For example, both defibrillation electrodes need not be mounted on a single liner, as shown in
FIG. 4 . Instead, each electrode may be mounted on its own liner. The electrodes may include visual cues other than tabs and arrows that tell the operator to remove the liner. - The instructive pictures on the pouch and electrodes need not be line drawings. Other visual information, such as photographs, may also be employed. Although the invention instructs the operator with no written explanatory text, the invention also encompasses embodiments having written instructions on the AED, the pouch, the electrodes, or elsewhere. The invention further encompasses embodiments in which instructions are provided audibly or with a visual display.
- Furthermore, the invention may be practiced with a variety or medical devices and is not limited to an AED. The invention may be practiced, for example, with a defibrillator-monitor, which may be used to display the heart rhythm of the patient on an LCD screen, CRT screen or other display. A defibrillator-monitor may deliver a defibrillation shock when needed, but a defibrillator-monitor may also be used for monitoring or diagnostic purposes.
- These and other embodiments are within the scope of the following claims.
Claims (36)
Priority Applications (1)
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US11/429,513 US7797044B2 (en) | 2001-10-02 | 2006-05-05 | Easy-to-use electrode and package |
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US33135801P | 2001-10-02 | 2001-10-02 | |
US10/008,243 US7069074B2 (en) | 2001-11-07 | 2001-11-07 | Easy-to-use electrode and package |
US10/262,536 US20030114885A1 (en) | 2001-10-02 | 2002-09-30 | System and device for implementing an integrated medical device component package |
US11/429,513 US7797044B2 (en) | 2001-10-02 | 2006-05-05 | Easy-to-use electrode and package |
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US10/262,536 Continuation-In-Part US20030114885A1 (en) | 2001-10-02 | 2002-09-30 | System and device for implementing an integrated medical device component package |
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US20100063558A9 true US20100063558A9 (en) | 2010-03-11 |
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US11/429,513 Expired - Fee Related US7797044B2 (en) | 2001-10-02 | 2006-05-05 | Easy-to-use electrode and package |
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WO2014181277A1 (en) * | 2013-05-09 | 2014-11-13 | Koninklijke Philips N.V. | Defibrillator electrode having adult and pediatric graphics |
Also Published As
Publication number | Publication date |
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US7069074B2 (en) | 2006-06-27 |
US20060206152A1 (en) | 2006-09-14 |
US20030088276A1 (en) | 2003-05-08 |
US7797044B2 (en) | 2010-09-14 |
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