E Series ® Operator’s Guide 9650-1210-01 Rev.
The issue date for the E Series Operator's Guide (REF 9650-1210-01 Rev. R) is March, 2013. If more than 3 years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. Copyright © 2013 by ZOLL Medical Corporation. All rights reserved.
TABLE OF CONTENTS SECTION 1 GENERAL INFORMATION.................................................................. 1-1 Product Description.............................................................................................. 1-1 How to Use This Manual....................................................................................... 1-2 Manual Updates..................................................................................................... 1-2 Unpacking................................
E Series Operator’s Guide SECTION 2 OPERATING CONTROLS AND INDICATORS ................................... 2-1 Code Markers .........................................................................................................2-4 Summary Report Function....................................................................................2-4 Summary Report Formats....................................................................................2-4 Defibrillation Format....................................
Table of Contents FULLY RELEASE Prompt....................................................................................7-2 CPR Voice Prompts .............................................................................................7-2 Compressions Bar Graph ....................................................................................7-2 Displaying the CPR Compressions Bar Graph ....................................................7-3 CPR Dashboard ...............................................
E Series Operator’s Guide NIBP Trend Operation .......................................................................................10-6 Clearing Vital Signs Trend Records...................................................................10-7 SECTION 11 GENERAL MAINTENANCE .............................................................. 11-1 Inspection ............................................................................................................. 11-1 Cleaning................................
Table of Contents PCMCIA Card ........................................................................................................ A-5 Battery Packs ........................................................................................................ A-5 Guidance and Manufacturer’s Declaration — Electromagnetic Emissions .... A-7 Electromagnetic Immunity Declaration (EID) ..................................................... A-8 EID for Life-Support Functions ........................................
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SECTION 1 GENERAL INFORMATION NOTE: Your E Series® may or may not contain all the features listed in this manual, depending on your particular configuration. Product Description The ZOLL® E Series products combine defibrillation, ECG display, advanced monitoring capabilities, and Noninvasive Transcutaneous Pacing (NTP) with communication, data printing and recording capabilities in a single lightweight portable instrument.
E Series Operator’s Guide How to Use This Manual The E Series Operator's Guide provides information operators need to know for the safe and effective use and care of the E Series products. Before operating this device, be sure to read and understand all the information contained within. This manual is organized for Manual mode operators, Advisory mode operators and Semiautomatic mode operators. If you will only use the device in Manual mode or Advisory mode you do not need to read Section 5.
General Information AAMI 5-Lead Wire ECG Patient Cable 8000-1005-01 IEC 5-Lead Wire ECG Patient Cable 8000-0091 Power Cord Extension Cable (12”) 8000-0730 Batteries and Chargers REF ZOLL Base PowerCharger 4x4 Battery Charger 8050-0012-01 Smart Battery Pack 8004-0103-01 SmartReady Battery Pack 8004-0104-01 ZOLL SurePower Charger 8050-0030-01 SurePower defibrillator battery 8019-0535-01 Miscellaneous REF Storage Bag Set 8000-0916 Recorder Paper, 80mm Fan Fold 8000-0301 (20 packages) 800
E Series Operator’s Guide Symbols Used on the Equipment Any or all of the following symbols may be used in this manual or on this equipment: Type B equipment. Type BF equipment. Type CF equipment. Defibrillator-proof type BF equipment. Defibrillator-proof type CF equipment. Attention, consult accompanying documents. Fragile, handle with care. Keep dry. This end up. Temperature limitation. Fusible Link. Equipotentiality. Protective (earth) ground terminal. DANGER High Voltage present.
General Information Conformité Européenne Complies with the medical device directive 93/42/EEC. ,%! $ 2. 45 2% 2%#9#,% 0B Contains lead. Recycle or dispose of properly. Keep away from open flame and high heat. Do not open, disassemble, or intentionally damage. Do not crush. Nonrechargeable battery Do not discard in trash. Recycle or dispose of properly. Date of manufacture. Use by. Latex-free. Do not reuse. Do not fold. Not sterile. Nonionizing electromagnetic radiation.
E Series Operator’s Guide Manufacturer. Authorized representative in the European Community. Serial Number. Catalogue number. Consult instructions for use. IP34 1-6 Protected against ingress of solid foreign objects > 2.5 mm in diameter. Protected against splashing water. 9650-1210-01 Rev.
General Information Defibrillator Function Intended Use — CPR Monitoring The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient’s ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation.
E Series Operator’s Guide External Pacemaker Function (Pacer version only) • Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy.
General Information This reddening should substantially lessen within 72 hours. There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised.
E Series Operator’s Guide • PAD CONTACT are alternately displayed, and energy will not be delivered If a short circuit exists between MFE Pads, the message DEFIB PAD SHORT is displayed. Monitor The patient’s ECG is monitored by connecting the patient to the unit via the 3 lead or 5 lead wire patient cable, MFE Pads, or through the paddles.
General Information Safety Considerations The E Series products are high energy devices capable of delivering up to 200 joules. To completely deactivate the device, you must turn the selector switch to the OFF position.
E Series Operator’s Guide • • • • • • • • • The potential equalization connector on the rear connector panel of the device has no function during physiological monitoring or delivery of therapy. Follow all recommended maintenance instructions. If a problem occurs, obtain service immediately. Do not use the device until it has been inspected by the appropriate personnel. Do not use the unit’s ECG out signal as a sync pulse for another defibrillator or cardioverter.
General Information • • • • • • • • • • • • • • • The AutoPulse Plus is only intended for use on adults 18 years of age or older. When using the E Series and AutoPulse Plus as a system, this age restriction applies to the E Series as well. Carefully route the patient cables to reduce the possibility of patient entanglement or strangulation. Do not use the unit’s AED function on patients under 8 years of age.
E Series Operator’s Guide Restarting the Device Certain events require the E Series products to be restarted after they shut off or become inoperative. One example is when the battery runs down and the unit shuts off. In this case, perform these steps in this order: 1. 2. 3. 4. Turn the selector switch to the OFF position Remove the battery. Insert a new battery. Turn the selector switch to the desired operating mode to resume operation.
General Information FDA Regulations Tracking Requirements U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this device, you have the responsibility under this law to notify ZOLL Medical Corporation if this product has been: • • • received lost, stolen or destroyed donated, resold, or otherwise distributed to a different organization. If any of the events described above occur, please contact ZOLL Medical Corporation in writing with the following information: 1.
E Series Operator’s Guide For customers Return the unit to In the U.S.A. ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 Attention: Technical Service Department (SR number) Telephone: 1-800-348-9011 In Canada ZOLL Medical Canada Inc. 1750 Sismet Road, Unit #1 Mississauga, ON L4W 1R6 Attention: Technical Service Department (SR number) Telephone: 1-866-442-1011 In other locations The nearest authorized ZOLL Medical Corporation representative.
SECTION 2 OPERATING CONTROLS AND INDICATORS 9 6 7 8 10 21 3 #(!2'% ,%!$ ECG Sp02 % ll 3):% ,%!$ (2 x1. 204 !.!,):% 4 2 %.%2'9 3%,%#4 3):% !,!23530%.$ 98 RR CO2 2%#/2$%2 $%&)" -/.)4/2 1 20 /&& ECG 0!#%2 2!4% PPM 0!#%2 04:48 Alarms Sync On/Off 0!#%2 /540/24 M! 5 3(/#+ Param #(!2'%2 .)"0 35--!29 #/$% -!2+%2 15 16 22 14 /. 11 12 13 17 18 19 ZM-04-36 Rev. A 1. Selector Switch Allows selection of OFF, MONITOR, DEFIB, and PACER, (Pacer version only) modes.
E Series Operator’s Guide 4. SHOCK Button 10. RECORDER Buttons The SHOCK button illuminates when the defibrillator is charged and ready. Press and hold the button to discharge the defibrillator. Located on the unit’s front panel and another located on the sternum paddle (not shown), starts and stops the stripchart recorder. The SHOCK button is active only when using MFE Pads. The SHOCK button is not functional when external paddles are connected to the unit.
Operating Controls and Indicators 17. Pacer Output mA (Pacer Version Only) When pacing is selected, this control sets the amount of current delivered to the MFE Pads. For conscious patients, it should be gradually increased until capture is recognized. The selected current setting is indicated on the display. The next three items are located on the top of all units, as shown in the following figure. Data Card Slot 18.
E Series Operator’s Guide important that the electrode is locked correctly in position on the paddle handle. PEDI Button Adult Electrode (Shoe) clinical action without having to scroll through the list. If no code marker has been entered, the cursor highlights the first item in the list. Note: Selecting code markers out of order disables this feature.
Operating Controls and Indicators as well as space for patient name, date and comments. On the last event recorded, “SUMMARY COMPLETE” is printed at the bottom left of the recorder strip. Defibrillation Format The summary report function records 6 seconds of pre-shock and 9 seconds of post-shock patient ECG data. Also recorded are joules selected, joules delivered, sync if active (includes sync markers), ECG lead, ECG size, patient impedance, actual event time and date.
E Series Operator’s Guide Pacer Format (Pacer version only) The summary report function records 6 seconds of pre-pacer patient ECG data. Also recorded are the ECG lead, ECG size, patient's heart rate, actual event time and date. The date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event. Actual event date/time After establishing a paced rhythm, turning the recorder on briefly records the paced rhythm for later reports.
Operating Controls and Indicators Heart Rate Alarm Activated Format The summary report function records 6 seconds of pre-alarm patient ECG. Also recorded are the ECG lead, ECG size, patient's heart rate, actual event time, and date. The date/time printed on the top of the strip corresponds to the ECG data occurring 6 seconds before the event. If the pacer is on during this event, the pacing rate and pacing current are also recorded.
E Series Operator’s Guide and pacing current are also recorded. If async pace is active, the annotation “ASYNC PACE” is recorded. AED units additionally include shock count and AED mode annotations. Actual event date/time Analyze Format The summary report function records six seconds of pre analysis ECG and 12 seconds of ECG recorded during the ECG analysis interval with the annotation “SHOCK ADVISED” or “NO SHOCK ADVISED.” AED units additionally include shock count and AED mode annotations.
Operating Controls and Indicators Manual Mode Activated AED versions of the E Series will record a “MANUAL MODE STARTED” summary report event when the device is switched from Semiautomatic mode to Manual mode. 3. Use the scroll keys on top of the unit to scroll through the list of start times associated with different calls. --- NIBP kPa To print the stored information, press the SUMMARY button below the screen display.
E Series Operator’s Guide • • • • • Manual mode started (AED only) Alarms triggered Code markers Recorder turned on NIBP measurements activated (if option is included) • Select the Enter ( ) key from the keypad and press the Commit ( ) key on top of the unit. The highlight automatically advances to the Patient ID# line.
Operating Controls and Indicators Note: You cannot add a patient name to summary report events already stored in memory. The patient name is stored only with those summary events saved after the patient name has been entered. 5. When you have modified the patient name, move the cursor to the Enter ( ) key on the keypad and press the Commit ( ) key on top of the unit. Modifying a Patient Name and ID Number To change an existing patient name and identification number: 1.
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SECTION 3 MANUAL DEFIBRILLATION Paddles/pads are a defibrillation-protected Type BF patient connection. ECG leads are a defibrillation-protected Type CF patient connection. Emergency Defibrillation Procedure with Paddles or MFE Pads WARNING • • • To avoid risk of electrical shock, do not allow electrolyte gel to accumulate on hands or paddle handles. When defibrillating with paddles, use your thumbs to operate the SHOCK buttons in order to avoid operator shock.
E Series Operator’s Guide Note: When the unit is turned to MONITOR or DEFIB, the ECG source is set either to PADDLES (if paddles are connected to the Multi-Function cable), or to Multi-function pads (if paddles are not connected to the Multi-Function cable). If connected to the AutoPulse Plus, the APLS icon will be displayed and PADS will be the ECG source.
Manual Defibrillation 2 Charge Defibrillator 3 Deliver SHOCK Press the CHARGE button on the front panel (if using MFE pads) or on the apex paddle handle (if using paddles). WARNING • • #(!2'% !.!,9:% 3(/#+ %.%2'9 3%,%#4 or CHARGE Button on Apex Paddle CHARGE Button on Front Panel Note: If using paddles, if both SHOCK buttons on the paddles are depressed when you press the CHARGE button, the device does not charge and a RELEASE SHOCK BUTTON or other message appears on the display.
E Series Operator’s Guide device disarms. The charge ready tone stops, the charge indicator light, or the front panel SHOCK button light goes off, and the monitor message changes to DEFIB XXXJ SEL. Press the CHARGE button again to recharge the unit. Paddle Cleaning Paddle plates and handles must be thoroughly cleaned after each use. See “General Maintenance” on page 111 for correct cleaning procedure.
SECTION 4 ADVISORY DEFIBRILLATION When MFE Pads are used, the patient connection is considered to be defibrillationprotected Type BF. Advisory Defibrillation WARNING • • Do not use the unit’s Advisory function on patients under 8 years of age. The AutoPulse Plus is only intended for use on adults 18 years of age or older. When using the E Series and AutoPulse Plus as a system, this age restriction applies to the E Series as well.
E Series Operator’s Guide 1 Select DEFIB An ANALYZING ECG message is displayed for approximately 9 to 12 seconds while the patient’s ECG is analyzed. -/.)4/2 $%&)" /&& ECG 0!#%2 ANALYZING ECG The unit displays the DEFIB 120J SEL message on the monitor until you press the ANALYZE button. 00:01 Param Wave 2 ID# Alarms Sync On/Off ECG Once the analysis is complete, the unit indicates whether or not a shock is advised. When a non-shockable rhythm is detected, the message NO SHOCK ADV.
Advisory Defibrillation . NO SHOCK ADV. SCE LOW SHOCK ADVISED ECG ECG DEFIB 200J SEL. DEFIB 200J SEL. 00:01 00:01 Param Param Wave 2 ID# Alarms Sync On/Off ID# Alarms Sync On/Off If the patient’s SPI value is greater than the configured SPI threshold, the unit operates as previously described and issues the SHOCK ADVISED prompt.
E Series Operator’s Guide 3 Press SHOCK Continue Patient Care Continue patient care according to medical protocols. WARNING Advisory Function Messages Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge. Do not touch the bed, patient, or any equipment connected to the patient during defibrillation. A severe shock can result.
Advisory Defibrillation and does not require depression of the ANALYZE button for operation. • CHECK PADS / POOR PAD CONTACT The MFE Pads are no longer properly attached to the patient or the cable connections have become loose. Check that the MFE Pads are making good contact with the patient’s skin and that the cables are all securely connected. This voice prompt is issued only if MFE pads were previously connected to the patient.
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SECTION 5 AUTOMATED EXTERNAL DEFIBRILLATOR (AED) OPERATION MFE Pads are a defibrillation-protected Type BF patient connection. The AED unit has two modes of operation: Semiautomatic or Manual. This section describes the recommended method for analysis and defibrillation for the AED unit in Semiautomatic mode. However, if your local protocol requires a different procedure, follow that protocol. WARNING • • • Do not use the unit’s AED function on patients under 8 years of age.
E Series Operator’s Guide AED Semiautomatic Operation Before you begin: • • • Determine the patient’s condition following medical protocols and by verifying: – Unconsciousness – Absence of breathing, and – Absence of pulse If appropriate, begin CPR following medical protocol, and request additional assistance. Prepare the patient and attach the MFE pads as described in “MFE Pad Application/Connection” on page 1-9.
Automated External Defibrillator (AED) Operation When a non-shockable rhythm is detected, the unit displays a NO SHOCK ADV. message. 3 Press SHOCK WARNING • NO SHOCK ADV. ECG • 120J SEL. NO SHOCK ADVISED 00:15 Manual Mode Param ID# In this case, immediately check pulse and breathing and resume other treatment per protocol. If the patient’s rhythm is shockable, the unit displays a SHOCK ADVISED message. Warn all persons in attendance of the patient to STAND CLEAR prior to defibrillator discharge.
E Series Operator’s Guide ready for operation. Additional tone signals are described below. The messages that appear on the monitor depend upon the function the unit is performing, the mode selected, and the ECG information from the patient. The unit alternately displays two different messages in the same field of the display when two conditions are detected at the same time. For example, a LOW BATTERY message may alternately display on the same line of the monitor as the CHECK PADS prompt.
Automated External Defibrillator (AED) Operation • This prompt appears when the unit has detected a non-shockable rhythm. Check the patient’s pulse. have entered the access code correctly and the unit enters Manual mode. IF NO PULSE, PERFORM CPR* If you press the Return to Auto softkey, the unit returns to the Semiautomatic mode of operation. If you cannot detect a pulse, begin CPR protocols.
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SECTION 6 SYNCHRONIZED CARDIOVERSION Paddles are a defibrillation-protected Type BF patient connection. ECG leads are a defibrillation-protected Type CF patient connection. WARNING • • • Only skilled personnel trained in ACLS (Advanced Cardiac Life Support) and familiar with equipment operation should perform synchronized cardioversion. The precise cardiac arrhythmia must be determined before attempting defibrillation.
E Series Operator’s Guide Turn Selector Switch to MONITOR -/.)4/2 Press the SYNC softkey again to reactivate SYNC mode. Changing the selected energy does not turn off Sync mode. $%&)" You can configure the unit to stay in Sync mode after defibrillation if desired. /&& 2 Charge Defibrillator 0!#%2 Press the CHARGE button on the front panel or on the apex paddle handle (if paddles are used). Press the LEAD button to select the desired ECG lead.
Synchronized Cardioversion Once energy is delivered, the display simultaneously shows the XXXJ DELIVERED and DEFIB XXXJ SEL. messages. After approximately 5 seconds the XXXJ DELIVERED message disappears, and the DEFIB XXXJ SEL. message remains to indicate the selected energy level. If additional countershocks are necessary, re-adjust the energy level as necessary, press the SYNC softkey and repeat. Note the SYNC XXXJ SEL. message must be displayed prior to pressing the CHARGE button.
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SECTION 7 REAL CPR HELP The CPR sensor is defibrillation-proof Type BF equipment. WARNING • • • ® The Real CPR Help function is not intended for use on patients under 8 years of age. The CPRD-to-MFC connector is intended for use with the E Series, or other ZOLL defibrillators where indicated. Real CPR Help is disabled when using CPR-D-padz through an AutoPulse Plus.
E Series Operator’s Guide compression indicators and CPR idle time described in the next sections. compressions have been delivered for more than 20 minutes, dashes (---) will be displayed in this time field. CPR Compressions Indicator CPR Idle Time This rectangular bar shaped figure provides a quick, overall indicator of how well the rescuer's combined rate and depth of chest compressions match the AHA/ERC recommendations for adult CPR.
Real CPR Help Displaying the CPR Compressions Bar Graph When an appropriate rate and depth are achieved, these labels are not highlighted. To manually display the CPR compression bar graph, press the Wave 2 softkey until the bar graph is displayed. * * NIBP mmHg CO2 Whenever CPR-D-padz or CPR stat-padz are connected to the E Series unit and the CPR Dashboard is configured on, the unit illuminates the CPR Dashboard, replacing the right half of the Wave 2 display area.
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SECTION 8 SEE-THRU CPR WARNING • • • • • The See-Thru CPR filter works only when the E Series defibrillator is monitoring CPR in Manual mode. The See-Thru CPR filter stops if: — Diagnostic bandwidth mode is active. — The unit is in pace mode. — Patient impedance is invalid. — CPR-D-padz electrodes are no longer detected. The See-Thru CPR filter will not remove all CPR artifact. Always stop CPR to verify the patient’s ECG rhythm before making treatment decisions.
E Series Operator’s Guide The following figure shows a patient in Fine VF. It is difficult for a rescuer to discern this rhythm during CPR compressions. When the CPR filter turns on, the Fine VF rhythm becomes more obvious.
See-Thru CPR The following figure shows a patient in VF, which, during compressions, is slightly more difficult to discern. When viewing this ECG, it is possible to view the underlying rhythm as the filter is able to reject all of the CPR artifact.
E Series Operator’s Guide The following figure shows a patient in PEA, which could easily be mistaken for Fine VF because enough of the compression artifact leaks through to distort this signal. When the CPR filter turns on, the PEA is still not obvious because of the left over ripples from the CPR signal. About 14 seconds into this chart, the rhythm changes to asystole, which could easily be mistaken for coarse VF.
See-Thru CPR The following figure shows a patient with an organized rhythm where See-Thru CPR effectively filters out artifact created by CPR. SinusRhythm Raw ECG Raw ECG • | Filter ON Filtered ECG Filtered ECG CPR 0:00 CPR 0:12 SinusRhythm Raw ECG Raw ECG • | Filter OFF • | Filter ON Filtered ECG Filtered ECG CPR 0:12 CPR 0:24 SinusRhythm Raw ECG Raw ECG • | Filter OFF Filtered ECG Filtered ECG CPR CPR 0:24 0:36 12.5 mm/sec, 5 mm/mV 9650-1210-01 Rev.
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SECTION 9 NONINVASIVE TEMPORARY PACING (PACER VERSION ONLY) Paddles are a defibrillation-protected Type BF patient connection. ECG leads are a defibrillation-protected Type CF patient connection. WARNING • • • • • • To avoid risk of electrical shock, do not touch the gelled area of the MFE Pads while pacing. MFE Pads should be replaced after 8 hours of continuous pacing (2 hours for Radiolucent stat-padz) to ensure maximum patient benefit. Pacing with CPR-D-padz is not recommended.
E Series Operator’s Guide The pacer rate increments or decrements by a value of 2 ppm on the display when you turn the knob. Electrical Capture Electrical capture means that the unit is delivering sufficient electrical current to stimulate the heart as seen on the ECG trace. 0!#%2 2!4% PPM 0!#%2 /54054 M! WARNING • • Observe the pacing stimulus marker on the display or stripchart ( ) and verify that it is well-positioned in diastole.
NonInvasive Temporary Pacing (Pacer Version Only) by increasing the pacer output (mA) until every pacing marker is immediately followed by a wide QRS complex. • • Note that changing ECG leads and size can sometimes be helpful in determining capture. • Mechanical Capture The alarm continues to sound until the Clear Pace Alarm softkey is pressed. Mechanical capture is indicated when the patient’s pulse approximates the displayed pace rate.
E Series Operator’s Guide rate drops below the set pacing rate. The pacing rate should be set at a level sufficient for adequate cardiac output. 4. Check the threshold periodically. Asynchronous Pacing If ECG electrodes are not available or there is some circumstance that prevents or interferes with the surface ECG, it may be necessary to operate the pacemaker asynchronously. Perform asynchronous pacing only in emergency situations when there are no other alternatives. To pace asynchronously: 1.
SECTION 10 ECG MONITORING ECG leads are a defibrillation-protected Type CF patient connection. Introduction You can use the E Series products for either short-term or long-term ECG monitoring. IEC Color Coding AHA Color Placement of Electrodes Coding E Series products have built-in protection circuitry to prevent damage to their ECG monitoring circuits during defibrillation attempts.
E Series Operator’s Guide Monitoring Electrodes Attachment Attach snap-on leads to electrodes and check for good contact between the electrode and the lead termination. ,%!$ 3):% Peel the protective backing from the ECG electrode. Be careful to keep adhesive surface free of electrolyte gel. !,!23530%.$ 2%#/2$%2 CAUTION Only use electrodes that are well within the expiration date indicated on the package.
ECG Monitoring LEAD ECG SIZE HR x1 70 selected State value and moves the highlight to the next field on the right (Low limit field). • If you press the Next Field softkey after selecting AUTO, the unit sets the lower and upper limits to 80% and 120% of the patient’s currently measured heart rate if valid measurements are present for the vital sign. (Refer to appropriate Operator’s Guide parameter insert(s) for percentages associated with other parameters).
E Series Operator’s Guide 280 bpm with a default setting of 150 bpm. When the unit is monitoring a patient’s heart rate through pulse oximetry (SpO2), however, the unit automatically lowers the upper limit for the high heart rate alarm to 235 bpm. The unit restores the original high heart rate alarm limit when ECG monitoring resumes.
ECG Monitoring standard monitoring bandwidth when you release the RECORDER button. set to Yes in System Configuration. Refer to the E Series Configuration Guide for more information. 5-Lead Monitoring Vital Signs Trending You can perform 5-lead ECG monitoring with the appropriate ECG patient cable.
E Series Operator’s Guide If only one parameter is installed on the unit, the trend screen automatically appears when you press the Trend softkey. 09-Jun-10 CO2 TIME HR/PR SpO2 EtCO2 RR 5 MIN 36 4.1 100 13:35 120 13:30 119 100 4.3 13 13:25 120 99 3.7 15 13:20 119 99 3.7 15 Print Newer Older Zoom Data is printed on the stripchart in order of newest data to oldest data. Alarm conditions are indicated on the stripchart by placing brackets around alarmed values.
ECG Monitoring Clearing Vital Signs Trend Records The unit stores at least 24 hours of normal (non-alarmed, non-NIBP) trending samples before it is overwritten. If the unit is powered down while recording trend data, the corresponding gap in time is indicated on the display by a series of asterisks in the time field and no data points in any parameter fields.
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SECTION 11 GENERAL MAINTENANCE Resuscitation equipment must be maintained to be ready for immediate use. Perform the following operational checks at the beginning of every shift to ensure proper equipment operation and patient safety. Cleaning the Recorder Printhead To clean the recorder printhead, perform the following steps: Note: Self-test defibrillation and pacing data is automatically recorded on the PCMCIA data card, if present.
E Series Operator’s Guide Testing the Defibrillator (Semiautomatic Mode) Perform these tests on all AED units periodically. Power-Up Sequence Test Follow these steps to verify the unit’s power-up sequence. 1. Turn the selector switch on the front panel to the ON position 2. Verify the following: • The unit emits a 4-beep tone to indicate the power-up self test has been successfully completed. • The CHECK PADS message is displayed and announced.
General Maintenance 5. When charge ready tone sounds, use the defibrillator ENERGY SELECT buttons on either the sternum paddle or defibrillator front panel to change the selected energy to 20 joules. 6. Verify that the unit disarms itself. 7. Use the defibrillator ENERGY SELECT buttons on either the sternum paddle or defibrillator front panel to change the selected energy back to 30 joules. MFC Setup: 1. Plug the MFC cable into the unit, making sure it is not plugged into the test connector. 2.
E Series Operator’s Guide Changing Recorder Paper You should always check for adequate paper supply in the unit before operation. Failure to do so may result in insufficient paper to print out event information during clinical rescue. Follow these steps to change the paper: 1. Open the recorder module on top of the E Series unit. 2. Remove the paper from the tray. 3. Unfold the top sheet of a pad of thermal paper. You should not see a thick red line (which indicates the end of the pad).
General Maintenance Setting Time and Date Check the time and date on the recorder annotation. If it is not correct, reset the time and date (from System Utilities mode) manually, by dial-up to a National Institute for Science and Technology (NIST) site, or using the GPS synchronization feature. After implementing time reset using any of the methods described below, verify that the time and date are set correctly by pressing the RECORDER button to generate a stripchart recording.
E Series Operator’s Guide Error Message Description/Corrective Action BUSY The unit detected a busy signal from the selected NIST location. Retry. NO ANSWER The unit received no answer from the selected NIST location. Retry or select another NIST location. NO CARRIER The unit determined that the line is broken. Correct the line break and retry. HANG UP The unit received a hang up indication from the selected NIST location. Retry. MODEM DIAL ERROR The modem could not dial the phone number.
Operator’s Shift Checklist for E Series Products (Manual) Recommended checks and procedures to be performed at the start of each shift. For more detailed information, see the E Series Operator’s Guide. Date____________________________Location________________________________Unit Serial Number__________________ 1st 2nd 3rd Remarks 1. Condition Shift Shift Shift Unit clean, no spills, clear of objects on top, case intact 2. Multi-function Pads 1 set preconnected / 1 spare (check expiration dates) 3.
Operator’s Shift Checklist for E Series Products (Semiautomatic) Recommended checks and procedures to be performed at the start of each shift. For more detailed information, see the E Series Operator’s Guide. Date_____________________________Location __________________________Unit Serial Number ______________________ 1st 2nd 3rd Remarks 1. Condition Shift Shift Shift Unit clean, no spills, clear of objects on top, case intact 2.
SECTION 12 BATTERY MANAGEMENT Battery Care LOW BATTERY Message Safe, reliable use of the system requires a well designed battery management program to ensure that adequate battery power is always available. Whenever the unit detects a low battery condition, a LOW BATTERY message is displayed on the monitor once every minute, and a 2-beep low battery tone sounds once every minute or once every 5 minutes.
E Series Operator’s Guide 3. Turn the defibrillator back on to the selected mode of operation. Note: If a battery has been discharged below its safe limit (8.5 V), which could occur during long-term storage, the battery fault indicator illuminates when it is installed. In this case, the battery is not usable; remove it immediately. Replace with a fully-charged battery. (In emergency situations, you can use AC power.) If the unit is set to PACER mode, pacing may resume immediately after battery replacement.
Battery Management : Achieving Optimal Battery Pack Performance The following general practices will ensure the longest life from your battery pack: “Do’s and Don’ts” in using battery packs: • DO charge battery packs completely. When a battery pack exchange is required, place a fully charged battery in the unit. If you use a partially charged battery pack, it may result in a very short monitor/defibrillator run time.
E Series Operator’s Guide • DO exchange your battery packs regularly. Battery packs should be exchanged once per shift or once per day depending on their use. • DO carry a fully charged spare battery pack at all times. DON’T remove a partially charged battery pack from the battery charger. If a partially charged battery pack is used, a full charge is recommended before its next use. Repeated use after partial charging may quickly diminish the battery’s capacity, thereby shortening its life.
SECTION 13 TROUBLESHOOTING GUIDELINES The troubleshooting guidelines provided on the following pages are intended for use by non-technical medical personnel during device operation. This section addresses many of the common problems or questions that may arise during operation. If trouble persists after consulting this guide, contact the appropriate technical personnel or ZOLL Technical Service Department. A more detailed troubleshooting guide is found in the E Series Service Manual.
E Series Operator’s Guide Symptom Recommended Action Unit displays the TIME SYNCHRONIZATION REQUIRED message on power down. • More than two weeks have elapsed since the clock was last synchronized. Synchronize the clock as described in “Setting Time and Date” on page 11-5.” Unit displays the CABLE FAULT or PADDLE FAULT message. • Check the connection between the Multifunction cable and the MFE pads.
Troubleshooting Guidelines Recorder Symptom Recommended Action Unit displays the CHECK RECORDER prompt. • • • Ensure the recorder door is shut properly. Ensure adequate paper supply in recorder paper tray (see “Changing Recorder Paper” on page 11-4). Remove paper, check paper type, check recorder for paper jam, and then reload paper. Recorder makes stuttering sound when activated. • Check recorder for paper jam. Light or poor quality printing is observed.
E Series Operator’s Guide Pacer (Pacer version only) Symptom Recommended Action Unit displays the CHECK PADS prompt. • • • • No pacing marker ( ) present on the ECG trace. • • No ventricular capture beat after pacing marker is seen • on ECG display. • • • Patient receives intermittent pacing stimulus during standby pacing. • • • Ensure MFE Pads are connected to Multi-Function cable. Ensure electrode gel is not dry. Replace MFE Pads if necessary. Ensure good electrode-to-patient contact.
Troubleshooting Guidelines Defibrillator Symptom Recommended Action Excessive artifact when using paddles as ECG source. • • • • • • • Ensure PADDLES is selected. Firmly press paddles against patient skin. Use gel on paddles. Clean paddle surface. Check and clean between adult and pediatric shoe. Check cable for damage. Use MFE electrodes for ECG analysis. Defibrillator will not charge (energy level does not increment on display). • • Check SHOCK button(s) on paddles or front panel are not stuck on.
E Series Operator’s Guide Symptom Recommended Action No energy delivery to patient is apparent. • • • • Unit displays PADDLE FAULT message when connected to the AutoPulse Plus. Unit displays the CHECK PADS prompt. Under certain circumstances, some patients do not twitch when energy is delivered. Perform defibrillator self test as described in “General Maintenance” on page 11-1. Check for CHECK PADS and POOR PAD CONTACT messages alternating on the monitor.
Troubleshooting Guidelines AC Charger Symptom Recommended Action The green and orange-yellow CHARGER ON indicators • illuminate alternately. • • • Verify battery is installed. Turn unit ON to identify the fault condition. Replace battery pack with a fully charged battery pack. If problem persists, replace battery pack, unplug device from AC mains and plug device back into AC mains. Unit displays the LOW BATTERY message when it is plugged into AC mains.
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APPENDIX A SPECIFICATIONS General Size 5.75 in. high x 13.1 in. wide x 10.5 in. deep 14.6 cm high x 33.3 cm wide x 26.7 cm deep Weight Approximately 13.2 lbs (5.99 kg) Power 5 cells, 2 V/cell; wired in series (sealed lead acid battery pack) 3 cells, 4.2 V/cell; wired in series (lithium-ion battery pack) AC Power 100-120V ~ 50/60 Hz, 220-240V ~ 50 Hz, 220 VA DC Input (Optional) 10-29 V. 130 W Device Classification Class I and internally powered per IEC 60601-1.
E Series Operator’s Guide Pacemaker (Pacer version) Type VVI demand; asynchronous (fixed rate) when used without ECG leads or in ASYNC pacing mode Pulse Type Rectilinear, constant current Pulse Shape and Duration Rectilinear, 40 milliseconds ±2 milliseconds Pulse Amplitude Variable 0 mA to 140 mA ±5% or 5 mA, whichever is greater Digitally displayed on the monitor (increments or decrements by a value of 2 mA) Pacing Rate Variable from 30 ppm to 180 ppm ±1.
Paddles Standard apex/sternum adult and pediatric. Adult paddles slide off to expose pediatric paddles. Multi-Function Electrode (MFE) Pads Specifically designed adult anterior/posterior pregelled ZOLL MFE Pads and Multi-Function stat-padz packaged in pairs. Built-in Defibrillator Tester Provides verification of the defibrillator charging and discharging without removing paddles from storage wells or verification of unit configured with Multi-Function Cable.
E Series Operator’s Guide Heart Rate Alarm Screen icon indicates activated/deactivated status. User-selectable. Tachycardia 60 bpm - 280 bpm, bradycardia 20 bpm - 100 bpm Tall T-wave Rejection 1.0 mV Heart Rate Averaging The E Series averages the interval between the last 5 detected beats. On startup, the E Series averages the rate between detected beats once two beats are detected, until a full 5 beats have been received. The rate is updated every beat.
Display Screen Type High resolution, color liquid crystal display (LCD) Screen Size 5.63 inches (14.3 cm) diagonally Sweep Speed 25 mm/s Viewing Time 4 seconds Messages ERASING REPORT, INSERT CARD, CARD FULL, REPLACE BATTERY, LOW BATTERY, PERFORM CPR, ECG TOO LARGE, NOISY ECG, RETRY ANALYSIS, CHECK PATIENT, ANALYSIS HALTED, PRESS ANALYZE, NO SHOCK ADV.
E Series Operator’s Guide Operating Time For a new, fully charged battery pack at 20 °C: (68F) • • • For a new, fully charged battery pack at 20 °C: (68F) 40 defibrillator discharges at maximum • energy (200 J), or 2.75 hours of continuous ECG • monitoring, or 2.25 hours of continuous ECG • monitoring/pacing at 60 mA, 80 beats per minute. 100 defibrillator discharges at maximum energy (200 J), or 4.25 hours of continuous ECG monitoring, or 3.
Guidance and Manufacturer’s Declaration — Electromagnetic Emissions The E Series unit is intended for use in the electromagnetic environment specified below. Ensure that the E Series unit is used in such an environment. Emissions Test Compliance Electromagnetic Environment — Guidance RF emissions CISPR11 Group 1 The E Series unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
E Series Operator’s Guide Electromagnetic Immunity Declaration (EID) Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment — Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
EID for Life-Support Functions The life-support functionsa of the E Series unit are intended for use in the electromagnetic environment specified below. Ensure that the E Series unit is used in such an environment.
E Series Operator’s Guide Recommended Separation Distances from RF Equipment for E Series Life-Support Functions The life-support functionsa of the E Series unit is intended for use in an environment in which radiated RF disturbances are controlled.
EID for Non-Life-Support Functions The non-life-support functionsa of the E Series unit are intended for use in the electromagnetic environment specified below. Ensure that the unit is used in such an environment.
E Series Operator’s Guide Recommended Separation Distances from RF Equipment for E Series Non-Life-Support Functions The non-life-support functionsa of the E Series unit is intended for use in an environment in which radiated RF disturbances are controlled.
Rectilinear Biphasic Waveform Characteristics The following table shows the Rectilinear Biphasic™ waveform’s characteristics when discharged into 25 ohm, 50 ohm, 100 ohm, and 125 ohm loads at a maximum energy setting of 200 Joules.
E Series Operator’s Guide Table A-1.
25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-1. Rectilinear Biphasic Waveforms at 200 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-2. Rectilinear Biphasic Waveforms at 150 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-3.
E Series Operator’s Guide 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 Figure A-4. 1 2 3 4 5 6 7 8 9 10 11 12 Rectilinear Biphasic Waveforms at 100 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-5. Rectilinear Biphasic Waveforms at 85 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-6.
25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 0 A -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-7. Rectilinear Biphasic Waveforms at 50 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-8. Rectilinear Biphasic Waveforms at 30 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-9.
E Series Operator’s Guide 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 0 A -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-10. Rectilinear Biphasic Waveforms at 15 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-11. Rectilinear Biphasic Waveforms at 10 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-12.
25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-13. Rectilinear Biphasic Waveforms at 8 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-14. Rectilinear Biphasic Waveforms at 7 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-15.
E Series Operator’s Guide 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-16. Rectilinear Biphasic Waveforms at 5 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-17. Rectilinear Biphasic Waveforms at 4 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-18.
25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-19. Rectilinear Biphasic Waveforms at 2 Joules 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 40 175Ω 30 20 10 A 0 -10 -20 -30 -40 0 1 2 3 4 5 6 7 8 9 10 11 12 ms Figure A-20.
E Series Operator’s Guide 300, 360 J). A significance level of p=0.05 or less was considered statistically significant using Fischer’s Exact test. Also, differences between the two waveforms were considered statistically significant when the customary 95% or AHA recommended 90%* confidence interval between the two waveforms was greater than 0%. Results: The study population of 184 patients had a mean age of 63 ±14 years. 143 patients were males.
between the two waveforms were considered statistically significant when the 95% confidence interval between the two waveforms was greater than 0%. Results: The study population of 165 patients had a mean age of 66±12 years with 116 male patients. The total efficacy of consecutive rectilinear biphasic shocks was significantly greater than that of monophasic shocks. The following table displays the Kaplan-Meier (product-limit) survival curves for each of the two waveforms.
E Series Operator’s Guide Shock Conversion Estimator Use of a defibrillator shock is currently the best option for terminating ventricular fibrillation and restoring a life sustaining ECG rhythm [1]. Maintaining blood flow through the heart via cardiopulmonary resuscitation (CPR) has been shown to improve the chances of a successful defibrillation [1].
Number of ECG Rhythms with SPI > Threshold that were successfully converted Sensitivity = ------------------------------------------------------------------------------------------------------------Total number of ECG rhythms that were successfully converted Number of ECG rhythms with SPI Threshold that did not convert Specificity = ----------------------------------------------------------------------------------------- Sensitivity or Specificity Total number of ECG rhythms that did not convert SPI
E Series Operator’s Guide Table A-2. Accuracy Table of SCE Levels and Corresponding SPI Thresholds SCE Level SPI Threshold (mV-Hz) Sensitivity % Specificity % HIGH 7.4 95 57 MEDIUM 8.3 90 65 LOW 10.8 80 80 References: [1] Eftestol T, Sunde K, Steen PA. Effects of Interrupting Precordial Compressions on the Calculated Probability of Defibrillation Success during Out-of-Hospital Cardiac Arrest. Circulation 2002; 105:2270-2273. [2] Sota Y, Weil MH, Sun S, Tang W. Xie J, Noc M, Bisera J.
ECG Analysis Algorithm Accuracy • Sensitivity and specificity are expressions of ECG analysis algorithm performance when compared to ECG interpretation by a clinician or expert. Sensitivity refers to the algorithm’s ability to correctly identify shockable rhythms (as a percentage of the total number of shockable rhythms). Specificity refers to the algorithm’s ability to correctly identify non-shockable rhythms (as a percentage of the total number of non-shockable rhythms).
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APPENDIX B MEDICAL REPORT CAPABILITY The unit's medical report capability automatically records incident information for subsequent review and archiving. Data is stored on a removable PCMCIA Type II data card (memory card) for uploading to a properly equipped personal computer or hand held device. The medical report capability begins recording when the unit is turned on and continues until the unit is turned off. Patient ECG, unit status, date, time and control settings are recorded.
E Series Operator’s Guide • Press the Next Item softkey and then the Enter softkey to exit. When finished erasing memory cards, return the unit to normal use by powering the unit off and then back on. Transferring Data to a PC with a PCMCIA Data Card Reader RescueNet Code Review for Windows software version 4.00 or later must be installed on the PC to access any information stored on PCMCIA cards. Remove the data card from the unit. Insert the card into the PCMCIA data card reader on the PC.
Communication Settings upload the entire contents of the data card. You must configure the same communication settings on both the E Series unit and the PC or hand-held device for proper data transmission.
E Series Operator’s Guide Activating Automatic Data Transmission 1. Press the Param softkey from the main menu to display the Parameter menu. The unit can be placed into realtime mode for automatic data transmission. In this mode, you can transmit data in real time to a remote device running ZOLL Data Relay software. The remote device in turn sends the data to a ZOLL Data Relay service for appropriate processing and formatting.
3. To deactivate automatic data transmission, display the Summary menu (by pressing the SUMMARY button) and press the Data Relay Off softkey 3. Press the Patient Records softkey to display the Patient Records menu. Note: If you change the destination port while a record is already being transmitted, that transmission continues to the previously selected port. All other records in the queue will be transmitted to the newly-selected port.
E Series Operator’s Guide Message Possible Causes and Corrective Action NOT AN E SERIES The wrong type of card is DATA CARD installed. The unit operates, but no data is being stored. Message Possible Causes and Corrective Action SERIAL FAULT or E Series unit aborted transmission. Data retrieval pre-empted by other E Series operations (such as alarm conditions or defibrillation activity); unit could not retrieve data from memory. UPLOAD ABORTED Insert the correct type of card.
