Zoll m series_manual

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Zoll m series_manual

  1. 1. 9650-0200-01 Rev YF October, 2005OPERATOR’S GUIDESHOCKDEFIBMONITORPACEROFFANALYZELEADSIZE4:1ALARMSUSPENDCODEMARKERSUMMARYSUMMARYRELEASECHARGER ONRECORDERPACEROUTPUTmAPACERRATEppmCHARGEENERGYSELECT321CO2 HgRR31 x1.5 7217 PADS100Sp02 % ECGECGCO2Param Wave 2 AlarmsLEAD SIZE HRmmID# 12 Lead
  2. 2. An issue or revision date for this manual is shown on the front cover.If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if additionalproduct information updates are available.ZOLL, PD, stat.padz, PowerCharger, Connect Alarm, ZOLL Data Control Software, Smart Alarms, Speed Pack, andPreconnect are trademarks of ZOLL Medical Corporation. 12SL and Catalyst MUSE are trademarks of GE MedicalSystems.Copyright 2005 by ZOLL Medical Corporation. All rights reserved.
  3. 3. iiiTABLE OF CONTENTSSECTION 1 GENERAL INFORMATION.................................................................. 1-1Product Description.............................................................................................. 1-1How to Use This Manual....................................................................................... 1-2Manual Updates..................................................................................................... 1-2Unpacking.............................................................................................................. 1-2Accessories........................................................................................................... 1-2Symbols Used on the Equipment........................................................................ 1-3Defibrillator Function............................................................................................ 1-4Intended Use — Manual Operation..................................................................... 1-4Intended Use — Semiautomatic Operation (AED).............................................. 1-4............................................................................................................................ 1-4Semiautomatic Operation Contraindications for Use .......................................... 1-4Defibrillator Complications .................................................................................. 1-4Defibrillator Output Energy.................................................................................. 1-4External Pacemaker (Pacer Version Only).......................................................... 1-5Intended Use — Pacemaker............................................................................... 1-5Pacemaker Complications .................................................................................. 1-5Pediatric Pacing .................................................................................................. 1-6Monitor................................................................................................................... 1-6Recorder Function ................................................................................................ 1-6Paddle - Electrode Options .................................................................................. 1-6Batteries................................................................................................................. 1-6Internal Battery Charger....................................................................................... 1-6External Battery Charger...................................................................................... 1-7Diagnostics............................................................................................................ 1-7Safety Considerations .......................................................................................... 1-8WARNINGS ........................................................................................................ 1-8CAUTIONS........................................................................................................ 1-10Restarting the Device ......................................................................................... 1-10FDA Regulations ..................................................................................................1-11Tracking Requirements..................................................................................... 1-11Notification of Adverse Events .......................................................................... 1-11Warranty (U.S. Only) ............................................................................................1-11Software License................................................................................................. 1-12Service ................................................................................................................. 1-12U.S.A. Customers ............................................................................................. 1-12International Customers.................................................................................... 1-12Defibrillator Waveform Information................................................................... 1-13ECG Analysis Algorithm Accuracy ................................................................... 1-14Clinical Performance Results ............................................................................ 1-14
  4. 4. M SERIES OPERATOR’S GUIDEivSECTION 2 OPERATING CONTROLS AND INDICATORS................................... 2-1Code Markers .........................................................................................................2-3Summary Report....................................................................................................2-4Summary Report Formats....................................................................................2-4Defibrillation Format.............................................................................................2-4Pacer Format (Pacer version only) ......................................................................2-5Heart Rate Alarm Activated Format.....................................................................2-5VF Alarm Activated (Refer to Section 8)..............................................................2-5Recorder On Format............................................................................................2-5Analyze Format....................................................................................................2-6Manual Mode Activated .......................................................................................2-6Printing a Report....................................................................................................2-7Printing Part of a Report .......................................................................................2-7Adding Patient Name and ID# to a Report...........................................................2-7Printing an Incident Log........................................................................................2-7Erasing Summary Report Memory.......................................................................2-8SECTION 3 MANUAL DEFIBRILLATION ............................................................... 3-1Emergency Defibrillation Procedure with Paddles.............................................3-1Emergency Defibrillation Procedure with MFE Pads .........................................3-4Open Chest Defibrillation with Internal Handles and Electrodes......................3-6Troubleshooting.....................................................................................................3-6SECTION 4 ADVISORY DEFIBRILLATION............................................................ 4-1Advisory Defibrillation...........................................................................................4-1Advisory Function Messages ...............................................................................4-3Warning Messages ................................................................................................4-3Troubleshooting.....................................................................................................4-4SECTION 5 AUTOMATED EXTERNAL DEFIBRILLATOR (AED) OPERATION... 5-1Introduction............................................................................................................5-1AED Semi-Automatic Operation...........................................................................5-1Operating Messages............................................................................................5-3AED Manual Mode Operation................................................................................5-5AED Voice Prompts .............................................................................................5-5Troubleshooting.....................................................................................................5-5SECTION 6 SYNCHRONIZED CARDIOVERSION ................................................. 6-1General Information...............................................................................................6-1Synchronized Cardioversion ................................................................................6-1Troubleshooting.....................................................................................................6-3SECTION 7 NON-INVASIVE TEMPORARY PACING (PACER VERSION ONLY) 7-1Non-invasive Temporary Pacing ..........................................................................7-1
  5. 5. TABLE OF CONTENTSvSpecial Pacing Applications.................................................................................7-3Standby Pacing....................................................................................................7-3Asynchronous Pacing ..........................................................................................7-4Pediatric Pacing...................................................................................................7-4Troubleshooting ....................................................................................................7-4SECTION 8 ECG MONITORING ............................................................................. 8-1Introduction............................................................................................................8-1Preparations...........................................................................................................8-1Electrode Placement............................................................................................8-1Attach Monitoring Electrodes...............................................................................8-2Troubleshooting ....................................................................................................8-2Set the Controls.....................................................................................................8-2Spikes from Implantable Pacemakers .................................................................8-2Alarms.....................................................................................................................8-3Setting Alarm Limits.............................................................................................8-3Alarm Function.....................................................................................................8-3Alarm Limits .........................................................................................................8-3Suspending and Silencing Alarms .......................................................................8-3Smart Alarms .......................................................................................................8-4Recorder Operation...............................................................................................8-4Diagnostic Bandwidth ..........................................................................................8-4Five (5) Lead Monitoring .......................................................................................8-4Simultaneous 3 Lead Printing (If Configured)......................................................8-5Changing from Five (5) Lead to Three (3) Lead ECG Monitoring........................8-5Vital Signs Trending ..............................................................................................8-5Viewing Vital Signs Trending Data on the Display...............................................8-5Printing a Vital Signs Trend Report......................................................................8-6NIBP Trend Operation .........................................................................................8-6Clearing Vital Signs Trend Records.....................................................................8-6SECTION 9 GENERAL MAINTENANCE ................................................................ 9-1Periodic Testing.....................................................................................................9-1Inspection.............................................................................................................9-1Cleaning...............................................................................................................9-1Cleaning the Recorder Printhead.........................................................................9-1Semi-Automatic Defibrillator Testing...................................................................9-21. Power-Up Sequence Check............................................................................9-22. Defibrillator Test..............................................................................................9-23. Recorder Check (if applicable)........................................................................9-2Manual Defibrillator Testing..................................................................................9-21. Power-Up Sequence Check.............................................................................9-22. Delivered Energy and Shock Buttons ..............................................................9-23. Energy Delivery Test (Paddles/MFE Pads) .....................................................9-3
  6. 6. M SERIES OPERATOR’S GUIDEvi4. Pacer Operation (Pacer Version Only) ............................................................9-35. Recorder Check ...............................................................................................9-3Changing Paper .....................................................................................................9-4Setting Time and Date ...........................................................................................9-4Manual Method ....................................................................................................9-4Automated Method...............................................................................................9-4Operator’s Shift Checklist for M Series Products (Manual)...............................9-6Operator’s Shift Checklist for M Series Products (Semi-Automatic)................9-7SECTION 10 BATTERY MANAGEMENT ............................................................... 10-1Battery Care..........................................................................................................10-1Battery Life Expectancy .....................................................................................10-1Low Battery Message ........................................................................................10-1Changing the Battery Pack ................................................................................10-1Charging and Testing Battery Packs .................................................................10-2Achieving Optimal Battery Pack Performance..................................................10-2APPENDIX A SPECIFICATIONS................................................................................A-1General................................................................................................................... A-1Pacemaker (Pacer Version Only)......................................................................... A-2ECG Monitoring..................................................................................................... A-3Display ................................................................................................................... A-3Recorder ................................................................................................................ A-4PCMCIA Card.........................................................................................................A-4Battery Packs ........................................................................................................ A-4Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ...... A-5Electromagnetic Immunity Declaration (EID)..................................................... A-6EID for Life-Support Functions............................................................................ A-7Recommended Separation Distances from RF Equipment for the M Series Life-Support Functions................................................................................................ A-8EID for Non–Life-Support Functions................................................................... A-9Recommended Separation Distances from RF Equipment for the M SeriesNon–Life-Support Functions ............................................................................. A-10SECTION B TROUBLESHOOTING GUIDES ..........................................................B-1General................................................................................................................... B-1Monitor................................................................................................................ B-1Recorder ............................................................................................................. B-3Pacer (Pacer Version Only) ................................................................................ B-4Defibrillator.......................................................................................................... B-5AC Charger......................................................................................................... B-7APPENDIX C MEDICAL REPORT CAPABILITY .......................................................C-1PCMCIA Data Card................................................................................................ C-1
  7. 7. TABLE OF CONTENTSviiInstalling the PCMCIA Data Card ........................................................................ C-1Erasing A Memory Card....................................................................................... C-1Warning Messages ............................................................................................... C-2Transferring Data to a PC with a PCMCIA Data Card Reader........................... C-2Uploading Data to a PC via A Serial Link ........................................................... C-2Troubleshooting ................................................................................................... C-3Display Messages................................................................................................. C-4
  8. 8. M SERIES OPERATOR’S GUIDEviii(This page intentionally left blank.)
  9. 9. 1-1SECTION 1GENERAL INFORMATIONNOTE: Your M Series may or may not contain all the features listed in this manual,depending on your particular configuration.Product DescriptionThe ZOLL M Series products combine a defibrillator, ECG display, advanced monitoring capabilities, and NoninvasiveTranscutaneous Pacing (NTP) with communication, data printing and recording capabilities in a single lightweightportable instrument. The unit has been designed for all resuscitation situations and its small, compact, lightweightdesign makes it ideal for accompanying patients during transport. The product is powered by AC or DC mains and aneasily replaced battery pack that is quickly recharged in the device when it is connected to AC or DC mains. In addition,the units batteries may be recharged and tested using ZOLL PowerCharger systems designed for standardinterchangeable ZOLL battery packs.The product is designed for use in both the hospital and the rugged EMS environment. All of its ruggedized featuresadd to its durability in hospital applications. The device is a versatile automated external defibrillator with or withoutmanual capabilities and may be configured to operate in manual, advisory or semi-automated modes. Semi-automatedversions of the device have a distinctive front panel with a single “ON” position. Conventional hospital style devices,which can be configured for manual, advisory or semi-automated operation, have a standardized ZOLL operatorinterface. When operating in the manual configuration the device operates as a conventional defibrillator where thedevice’s charging and discharging is fully controlled by the operator. In advisory and semi-automatic modes, somefeatures of the device are automated and a sophisticated detection algorithm is used to identify ventricular fibrillationand determine the appropriateness of defibrillator shock delivery. Units may be configured to automatically charge,analyze, recharge, and prompt the operator to “PRESS SHOCK”, depending on local protocols. The unit is switchedfrom the semi-automated mode to manual mode for ACLS use by pressing the appropriate soft key on the front panel.Information regarding the unit’s operation, patient ECG, and other physiological waveforms are displayed on a large5.66 inch diagonal display which provides high contrast and visibility under virtually all lighting conditions. Operatingand warning messages are displayed on the monitor and the unit can also be configured with voice prompts to alert theuser to unit status. Self-diagnostic tests are performed when the instrument is turned on and the unit is periodicallytested during operation.A sophisticated data collection system, an optional internal summary report feature with printer, and PCMCIA cards areavailable for this unit. A PCMCIA card can be installed in the unit to record ECG and virtually all device data when thedevice is turned on. In addition, voice data from any incident around this device can also be recorded. The data storedon the PCMCIA card can be reviewed and archived on a properly equipped personal computer using ZOLL DataControl software.An annotating strip chart recorder can be included to provide immediate documentation as well as summary reportfunctions about patient care and treatment during use.Some M Series products are intended for use in the semiautomatic mode by first responders and emergency medicaltechnicians certified by an appropriate federal, state or local government authority. Some M Series products areintended for use in manual mode by personnel certified by appropriate federal, state or local authority to provideadvanced life support care.Some M Series products are intended for use in the pre-hospital emergency medical care setting, indoors andoutdoors, including first response vehicles, fire vehicles, basic and advanced level ambulances as well as by bothBasic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) staff in hospitals under protocol control.
  10. 10. M SERIES OPERATOR’S GUIDE1-2How to Use This ManualThe M Series Operators Guide provides information operators need for the safe and effective use and care of theM Series products. It is important that all persons using this device read and understand all the information containedwithin.This manual is organized for manual mode operators, advisory mode operators and semiautomatic mode operators. Ifyou will only use the device in manual mode or advisory mode you do not need to read Section 5. If you will only usethe device in semi-automatic mode you do not need to read Sections 3, 4, or 6.Please read thoroughly the safety considerations and warnings section.Procedures for daily checkout and unit care are found in the Maintenance Section.This manual is supplemented by manual inserts for options available on the M Series. These inserts contain additionalwarnings, precautions, and safety-related information.Manual UpdatesZOLL Medical Corporation provides Manual Updates to inform customers of changes in device information and use.The updates are mailed to each registered M Series purchaser automatically. All users should carefully review eachmanual update to understand its significance and then file it in its appropriate section within this manual for subsequentreference.UnpackingCarefully inspect each container for damage. If the shipping container or cushion material is damaged, it should bekept until the contents have been checked for completeness and the instrument has been checked for mechanical andelectrical integrity. If the contents are incomplete, if there is mechanical damage, or if the instrument does not pass itselectrical self-test, U.S.A. customers should call ZOLL Medical Corporation (1-800-348-9011). International customersshould contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify thecarrier.AccessoriesNote: The terms “ZOLL Multi-Function Electrode (MFE) Pads” and “MFE Pads” are used interchangeably throughoutthis manual.• Service Manual• Internal Defibrillator Handles and Cable Assembly *• Internal Defibrillator Electrodes: 3.0" (7.6 cm), 2.7" (6.8 cm), 2.0" (5.1 cm), 1.6" (4.0 cm), & 1.0" (2.5 cm) diameter.*• Adult, Multi-Function pacing/defibrillation electrode pads (12 pair/box)• Pediatric, Multi-Function pacing/ defibrillation electrode pads (6 pair/box)• Adult Multi-Function pacing/defibrillation Stat Padz• Multi-Function Cable assembly for use with Multi-Function pacing/defibrillation Electrode Pads*• Base PowerCharger4x4• Base PowerCharger1x1• ECG Simulator• Battery Management Program Manual• Replacement battery packs*• Smart Batteries• AAMI Standard 3-lead ECG patient cable & 5-lead ECG patient cable• IEC Standard 3-lead ECG patient cable & 5-lead ECG patient cable• Carry Case* These accessories are considered safety-relevant components
  11. 11. General Information1-3Symbols Used on the EquipmentAny or all of the following symbols may be used in this manual or on this equipment:Type B patient connectionType BF patient connectionType CF patient connectionDefibrillation protected Type BF patient connectionDefibrillation protected Type CF patient connectionAttention Refer to manual for more informationFusible LinkProtective (earth) ground terminalDANGER High Voltage presentAlternating currentConformité Européenne Complies with the medical device directive 93/42/EEC
  12. 12. M SERIES OPERATOR’S GUIDE1-4Defibrillator FunctionThe M Series products contain a DC defibrillator capableof delivering up to 360 joules of energy. It may be used insynchronized mode to perform synchronizedcardioversion by using the R-wave of the patient’s ECGas a timing reference. The unit uses paddles ordisposable, pre-gelled, MFE Pads for defibrillation.Intended Use — Manual OperationUse of the M Series products in the manual mode fordefibrillation is indicated on victims of cardiac arrestwhere there is apparent lack of circulation as indicatedby:• Unconsciousness• Absence of breathing• Absence of pulse.This product should be used only by qualified medicalpersonnel for converting ventricular fibrillation and rapidventricular tachycardia to sinus rhythm or other cardiacrhythms capable of producing hemodynamicallysignificant heart beats.Intended Use — Semiautomatic Operation (AED)The M Series products are designed for use byemergency care personnel who have completed trainingand certification requirements applicable to the use of adefibrillator where the device operator controls deliveryof shocks to the patient.They are specifically designed for use in earlydefibrillation programs where the delivery of adefibrillator shock during resuscitation involving CPR,transportation, and definitive care are incorporated into amedically-approved patient care protocol.The M Series products must be prescribed for use by aphysician or medical advisor of an emergency responseteam.Use of the device in the Semiautomatic mode fordefibrillation is indicated on victims of cardiac arrestwhere there is apparent lack of circulation as indicatedby:• Unconsciousness• Absence of breathing• Absence of pulse.Specifications for the ECG rhythm analysis function areprovided at the end of this section.Semiautomatic Operation Contraindications for UseThe rhythm analysis function may not reliably identifyventricular fibrillation in the presence of an implantablepacemaker. Inspection of the electrocardiogram andclinical evidence of cardiopulmonary arrest should be thebasis for any treatment of patients with implantablepacemakers.Do not use the rhythm analysis function during patientmovement on a stretcher or in an ambulance or otherconveyance. A patient must be motionless during ECGanalysis. Do not touch the patient during analysis. Ceaseall movement via stretcher or vehicle prior to analyzingthe ECG. If using the device in an emergency vehicle,bring the vehicle to a halt before activating the analysisfunction.Note: Do not use the unit’s AED function on patientsunder 8 years of age.Defibrillator ComplicationsInappropriate defibrillation or cardioversion of a patient(e.g., with no malignant arrhythmia) may precipitateventricular fibrillation, asystole, or other dangerousarrhythmias.Defibrillation without proper application of electrode padsor paddle electrolyte gel may be ineffective and causeburns, particularly when repeated shocks are necessary.Erythema or hyperemia of the skin under the paddles orMFE Pads often occurs; this effect is usually enhancedalong the perimeter of the paddle or electrode. Thisreddening should substantially lessen within 72 hours.Defibrillator Output EnergyThe M Series products may deliver up to 360 joules intoa 50 ohm impedance. The energy delivered through thechest wall, however, is determined by the patientstransthoracic impedance. An adequate amount ofelectrolyte gel must be applied to the paddles and aforce of 10-12 kilograms must be applied to each paddlein order to minimize this impedance. If MFE Pads areused, make sure that they are properly applied. (Refer tothe instructions on the Multi-Function Electrodepackage).
  13. 13. General Information1-5External Pacemaker (Pacer VersionOnly)Non-invasive Transcutaneous Pacing (NTP) is anestablished and proven technique. This therapy is easilyand rapidly applied in both emergency and non-emergency situations when temporary cardiacstimulation is indicated.Some M Series products may contain an optionaldemand pacemaker consisting of a pulse generator andECG sensing circuitry. The output current of thepacemaker is continuously variable from 0 to 140 mAand the rate is continuously variable from 30 to 180pulses per minute (ppm).The pacing output pulse is delivered to the heart byspecially designed ZOLL MFE Pads placed on the backand the precordium.The characteristics of the output pulse, together with thedesign and placement of the electrodes, minimizecutaneous nerve stimulation, cardiac stimulationthreshold currents, and reduce discomfort due to skeletalmuscle contraction.The unique design of the M Series products allow clearviewing and interpretation of the electrocardiogram(ECG) on the display without offset or distortion duringexternal pacing.Proper operation of the device, together with correctelectrode placement, is critical to obtaining optimalresults. Every operator must be thoroughly familiar withthese operating instructions.Intended Use — PacemakerThis product may be used for temporary external cardiacpacing in conscious or unconscious patients as analternative to endocardial stimulation.Note: This device must not be connected to internalpacemaker electrodes.The purposes of pacing include:Resuscitation from standstill or bradycardia of anyetiology:Noninvasive pacing has been used for resuscitation fromcardiac standstill, reflex vagal standstill, drug inducedstandstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatoryarrest (due to anesthesia, surgery, angiography, andother therapeutic or diagnostic procedures). It has alsobeen used for temporary acceleration of bradycardia inStokes-Adams disease and sick-sinus syndrome. It issafer, more reliable, and more rapidly applied in anemergency than endocardial or other temporaryelectrodes.As a standby when standstill or bradycardia might beexpected:Noninvasive pacing may be useful as a standby whencardiac arrest or symptomatic bradycardia might beexpected due to acute myocardial infarction, drugtoxicity, anesthesia or surgery. It is also useful as atemporary treatment in patients awaiting pacemakerimplants or the introduction of transvenous therapy. Instandby pacing applications, noninvasive pacing mayprovide an alternative to transvenous therapy that avoidsthe risks of displacement, infection, hemorrhage,embolization, perforation, phlebitis and mechanical orelectrical stimulation of ventricular tachycardia orfibrillation associated with endocardial pacing.Suppression of tachycardia:Increased heart rates in response to external pacingoften suppress ventricular ectopic activity and mayprevent tachycardia.Pacemaker ComplicationsVentricular fibrillation will not respond to pacing andrequires immediate defibrillation. The patient’sdysrhythmia must therefore be determined immediately,so that appropriate therapy can be employed. If thepatient is in ventricular fibrillation and defibrillation issuccessful, but cardiac standstill (asystole) ensues, thepacemaker should be used.Ventricular or supraventricular tachycardias may beinterrupted with pacing but in an emergency or duringcirculatory collapse, synchronized cardioversion is fasterand more certain. (See Synchronized CardioversionSection.)Electromechanical dissociation may occur followingprolonged cardiac arrest or in other disease states withmyocardial depression. Pacing may then produce ECGresponses without effective mechanical contractions,and other treatment is required.Pacing may evoke undesirable repetitive responses,tachycardia, or fibrillation in the presence of generalizedhypoxia, myocardial ischemia, cardiac drug toxicity,electrolyte imbalance, or other cardiac diseases.Pacing by any method tends to inhibit intrinsicrhythmicity. Abrupt cessation of pacing, particularly atrapid rates, can cause ventricular standstill and shouldbe avoided.Noninvasive Temporary Pacing may cause discomfort ofvarying intensity, which occasionally can be severe andpreclude its continued use in conscious patients.Similarly, unavoidable skeletal muscle contraction maybe troublesome in very sick patients and may limitcontinuous use to a few hours. Erythema or hyperemiaof the skin under the MFE Pads often occurs; this effectis usually enhanced along the perimeter of the electrode.
  14. 14. M SERIES OPERATOR’S GUIDE1-6This reddening should substantially lessen within 72hours.There have been reports of burns under the anteriorelectrode when pacing adult patients with severelyrestricted blood flow to the skin. Prolonged pacingshould be avoided in these cases and periodicinspection of the skin is advised.There are reports of transient inhibition of spontaneousrespiration in unconscious patients with previouslyavailable units when the anterior electrode was placedtoo low on the abdomen.This device must not be connected to internalpacemaker electrodes.Pediatric PacingPacing can be performed on pediatric patients weighing33lbs / 15kg or less using special ZOLL pediatric MFEPads. Prolonged pacing (in excess of 30 minutes),particularly in neonates, could cause burns. Periodicinspection of the underlying skin is recommended.MonitorThe patient’s ECG is monitored by connecting the patientto the unit via the 3 or 5 lead patient cable, MFE Pads, orthrough the paddles. Four seconds of ECG is presentedon the display along with the following information:• averaged heart rate, derived from measuring R to Rintervals• lead selections - I, II, III, aVR, aVL, aVF, V (with ECGcable), PADDLES, or PADS• ECG size - 0.5, 1, 1.5, 2, 3 cm/mV• pacemaker output in milliamps (Pacer version only)• pacemaker stimulus rate in pulses per minute (Pacerversions only)• defibrillator output in joules• other operational prompts, messages, and diagnostic codesMonitoring or diagnostic ECG bandwidth is selectable.Recorder FunctionA strip recorder is provided to document events. Thestrip recorder normally operates in the delay mode (6seconds) to insure capture of critical ECG information.The recorder may be activated manually by pressing theRECORDER button. It will be activated automaticallywhenever a defibrillation SHOCK is delivered, a heartrate alarm occurs, or the rhythm analysis function isactivated. The strip recorder may also be configured notto print during these events.Paddle - Electrode OptionsThe M Series products will defibrillate, cardiovert andmonitor ECG using either defibrillation paddles or ZOLLMulti-Function Electrode (MFE) Pads.The pacer version of the M Series will also pace usingZOLL MFE Pads.Energy Select, Charge, and Shock controls are locatedon the paddles and front panel. When using MFE Pads,the controls on the front panel of the unit must be used.To switch between paddles and MFE Pads, removeMulti-Function cable from the apex paddle and connectthe MFE pads to the Multi-Function cable.The Advisory function cannot be activated unless MFEPads are attached to the Multi-Function Cable and usedas the ECG monitoring lead.Note: The MFE Pads, Pediatric MFE Pads, Stat Padz,and ECG electrodes (not the ECG cable) aredisposable, single-use items.BatteriesThe M Series products use easily replaced sealed, lead-acid battery packs that, when new and fully charged, willprovide at least 2.5 hours of monitoring. Use of thedefibrillator, strip chart recorder, and pacemaker willreduce this time.When a “LOW BATTERY” message appears on thedisplay and the unit emits two beeps in conjunction withthe displayed message, the battery must be replacedand recharged.Internal Battery ChargerBattery charging can be performed within the device viaAC mains, an optional DC input, or by using an externalbattery charger.When the M Series products are plugged into AC mainsor to a DC power supply, the CHARGER ON indicatorswill operate in the following manner:The orange-yellow CHARGER ON indicator willilluminate continuously whenever; the device is turnedOFF and charging the battery or turned ON with abattery installed.The green CHARGER ON indicator will illuminatecontinuously whenever the unit is turned OFF and theinstalled battery has been fully charged to presentcapacity.The green and orange-yellow Charger On indicators willilluminate alternately when no battery is installed in theunit or a battery charging fault has been detected.When the device is not connected to AC mains, theCHARGER ON indicators will remain extinguished.If your M Series unit does not function as expected, seethe AC Charger Troubleshooting section on page B-7.
  15. 15. General Information1-7External Battery ChargerExternal battery charging and capacity evaluation isperformed with the ZOLL Base PowerCharger4x4. Up tofour battery packs can be charged simultaneously andtesting is automatic. See the appropriate ZOLL batterycharger Operators Guide and Battery ManagementProgram for more detailed information on thespecifications, use and management of ZOLL batterypacks.DiagnosticsA computer contained within the unit performs self-diagnostic tests whenever the product is initially turnedon and periodically during operation. During operation, a“Function* FAULT XX” message will be displayed if afault is detected. If this occurs, turn the unit off and thenon and recheck operation. Contact authorized servicepersonnel if the message continues to be displayed.* Function: may include Recorder, Pace, Defib, etc.
  16. 16. M SERIES OPERATOR’S GUIDE1-8Safety ConsiderationsThe M Series products are high energy devices capableof delivering up to 360 joules. To completely deactivatethe device, you must turn the SELECTOR SWITCH tothe OFF position.In order to disarm a charged defibrillator:• Turn the SELECTOR SWITCH to MONITOR, OFF orPACER (pacer equipped versions only)or• Change the selected defibrillator energyAs a safety feature, the device will automatically disarm ifleft charged for more than 60 seconds (15 seconds forAED versions).Note: The terms “ZOLL Multi-Function Electrode (MFE)Pads” and “MFE Pads” will be usedinterchangeably throughout this manual.WARNINGSGeneral• Federal (U.S.A.) law restricts this device to use by or onthe order of a physician.• The use of external pacing/defibrillation electrodes oradapter devices from sources other than ZOLL is notrecommended. ZOLL makes no representations orwarranties regarding the performance or effectiveness ofits products when used in conjunction with pacing/defibrillation electrodes or adapter devices from othersources. Device failures attributable to the use of pacing/defibrillation electrodes or adapters not manufactured byZOLL may void ZOLLs warranty.• Proper operation of the unit, together with correctelectrode placement is critical to obtaining optimalresults. Operators must be thoroughly familiar withproper device operation.• Do not use the unit in semiautomatic mode during patientmovement. A patient must be motionless during ECGanalysis. Do not touch the patient during analysis. Ceaseall movement via stretcher or vehicle before analyzingthe ECG. If using the device in an emergency vehicle,bring the vehicle to a halt before using in semiautomaticmode.• The device is protected against interference from radiofrequency emissions typical of two-way radios andcellular phones (digital and analog) used in emergencyservice/public safety activities. Users should assess thedevice’s performance in their typical environment of usefor the possibility of radio frequency interference fromhigh-power sources. Radio Frequency Interference (RFI)may be observed as shifts in monitor baseline, tracecompression, display brightness changes or transientspikes on the display.• M Series units equipped with the Bluetooth® optioninclude an RF transmitter which transmits with 0dBmpower in the 2.4 GHz ISM band.• Do not operate the unit without a battery. Keep a fullycharged spare battery pack with the device at all times.• Regular use of partially charged battery packs withoutfully recharging between uses will result in permanentlyreduced capacity and early battery pack failure.• Test batteries regularly. Batteries that do not pass ZOLL’scapacity test could unexpectedly shutdown withoutwarning.• Replace the battery with a fully charged batteryimmediately after the “LOW BATTERY” or “REPLACEBATTERY” message.• Emergency defibrillation should be attempted only byappropriately trained, skilled personnel who are familiarwith equipment operation. Training appropriateness, suchas Advanced Cardiac Life Support (ACLS) or Basic LifeSupport (BLS) certification, should be determined by theprescribing physician.• Synchronized cardioversion should only be attempted byskilled personnel trained in Advanced Cardiac LifeSupport (ACLS) and familiar with equipment operation.The precise cardiac arrhythmia must be determinedbefore attempting defibrillation.• Prior to attempting synchronized cardioversion, ensurethat the ECG signal quality is good and that sync marksare displayed above each QRS complex.• These operating instructions describe the functions andproper operation of the M Series products. They are notintended as a substitute for a formal training course.Operators should obtain formal training from anappropriate authority prior to using the device for patientcare.• Do not disassemble the unit. A shock hazard exists. Referall problems to authorized service personnel.• Follow all recommended maintenance instructions. If aproblem occurs, obtain service immediately. Do not usethe device until it has been inspected by the appropriatepersonnel.• Do not use the unit’s ECG out signal as a sync pulse foranother defibrillator or cardioverter.
  17. 17. General Information1-9• The ECG out signal is delayed by up to 25 ms. This delaymust be considered when the ECG out signal is used as aninput to other devices requiring R-wave synchronization.• The M Series device may not perform to specificationswhen stored at the upper or lower extreme limits ofstorage temperature and immediately put into use.• Avoid using the M Series adjacent to, or stacked on otherequipment. If unavoidable, verify that the M Seriesoperates normally in this configuration before clinicaluse.• The M Series should be installed and put into serviceaccording to the Electromagnetic Compatibility (EMC)information in Appendix A of this manual.• The use of accessories, transducers, and cables other thanthose specified in this manual and related M Seriesoption manual inserts may result in increased emissionsor decreased immunity of the M Series.Operator Safety• Do not use M Series products in the presence of oxygen-rich atmospheres, flammable anesthetics or otherflammable agents (such as gasoline). Using theinstrument near the site of a gasoline spill may cause anexplosion.• Do not use the instrument near or within puddles ofwater. Electrical safety of the device may becompromised when wet.• Do not discharge with paddles or MFE Pads shortedtogether or in open air.• Warn all persons in attendance of the patient to STANDCLEAR prior to defibrillator discharge.• Do not touch the bed, patient, or any equipmentconnected to the patient during defibrillation. A severeshock can result. Do not allow exposed portions of thepatients body to come in contact with metal objects, suchas a bed frame, as unwanted pathways for defibrillationcurrent may result.• For defibrillation using paddles, utilize only highconductivity electrolyte gel specified by the manufacturerfor such use.• To avoid risk of electrical shock, do not allow electrolytegel to accumulate on hands or paddle handles.• To avoid risk of electrical shock, do not touch the gelledarea of the MFE Pads while pacing.• When defibrillating with paddles use your thumbs tooperate the SHOCK buttons in order to avoid inadvertentoperator shock. No portion of the hand should be near thepaddle plates.• Only use thumbs to depress the paddle SHOCK buttons.Failure to do so could result in the inadvertent depressionof the energy select buttons, causing the defibrillator todisarm itself.• Do not discharge the defibrillator except as indicated inthe instructions. Do not discharge the defibrillator if theMFE Pads are not properly attached to the patient.• Always check that the equipment functions properly andis in proper condition before use.• Disconnect all electro-medical equipment that is notdefibrillation protected from the patient prior todefibrillation.• The use of ACCESSORY equipment not complying withthe equivalent safety requirements of this equipment maylead to a reduced level of safety of the resulting system.Consideration relating to the choice shall include:• Use of the accessory in the PATIENT VICINITY• Evidence that the safety certification of theACCESSORY has been performed in accordance withthe appropriate IEC (EN) 60601-1 and/orIEC (EN) 60601-1-1 harmonized national standards.Patient Safety• Neonatal and pediatric defibrillation energy levels shouldbe set based on site-specific clinical protocols.• Do not use the unit’s AED function on patients under8 years of age. *• The device detects ECG electrical signals only. It will notdetect a pulse (i.e. effective circulatory perfusion).Always verify pulse and heart rate by physicalassessment of the patient. Never assume that a non-zeroheart rate display means that the patient has a pulse.• Implanted pacemakers may cause the heart rate meter tocount the pacemaker rate during incidents of cardiacarrest or other arrhythmias. Pacemaker patients should becarefully observed. Check the patients pulse; do not relysolely on heart rate meters. Dedicated pacemakerdetection circuitry may not detect all implantedpacemaker spikes. Patient history and physical exam areimportant in determining the presence of an implantedpacemaker.• Use only high quality ECG electrodes. ECG electrodesare for rhythm acquisition only. Do not attempt todefibrillate or pace through ECG electrodes.• The ECG rhythm analysis function does not warn theoperator of patient asystole, as it is not a shockablerhythm.• Do not use ECG electrodes or MFE Pads if the gel isdried, separated, torn, or split from the foil; patient burnsmay result from using such electrodes. Poor adherenceand/or air under the MFE Pads can lead to the possibilityof arcing and skin burns.• Excessive body hair or wet, sweaty skin can inhibit goodcoupling (contact), which can lead to the possibility ofarcing and skin burns. Clip excess hair and drysurrounding moisture from the area where the electrode isto be attached.• MFE Pads should be replaced after 8 hours of continuouspacing (2 hours for Radiolucent stat2padz) to ensuremaximum patient benefit).WARNINGS (Continued)
  18. 18. M SERIES OPERATOR’S GUIDE1-10* AHA Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, I-64, 2000.Restarting the DeviceCertain events require the M 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. The selector switch should always be turned to theOFF position before removing the battery. The selector switch may then be turned to the desired operating mode toresume operation after insertion of a new battery. This sequence is needed to restart the device, and can also be usedto clear some “X FAULT XX” messages, if immediate use of the device is required.Note that some settings (for example, alarm settings, lead selection, ECG size) may need to be restored from theirdefault values when operation is resumed.• To avoid electrosurgery burns at monitoring sites, ensureproper connection of the electrosurgery return circuit sothat the return paths cannot be made through monitoringelectrodes or probes.• Prolonged pacing (in excess of 30 minutes), particularlyin neonates or adults with severely restricted blood flow,may cause burns. Periodic inspection of the underlyingskin is recommended.• Check leakage levels prior to use. Leakage current maybe excessive if more than one monitor or other piece ofequipment is connected to the patient.CAUTIONS• Do not install the battery into the device when storage may exceed 90 days. Battery damage may occur.• The “LOW BATTERY” message display-to-shutdown interval may be less than one minute when olderbatteries become depleted.• The M Series ships standard with a PD 4410 battery, but can optionally use the XL battery if properlyconfigured. Incorrectly configuring the unit for XL battery operation when the PD 4410 is installed willsubstantially reduce the number of defibrillation shocks that can be delivered between the onset of the“LOW BATTERY” warning message and M Series shutdown. (See the M Series Configuration Guide,P/N 9650-0201-01, for complete details on properly configuring the selected battery type.)• Do not sterilize the device.• Do not immerse any part of the device in water.• Do not use alcohol or ketones (MEK, acetone, etc.) on the device.• Avoid using abrasives (e.g. paper towels) on the display window.• Grounding reliability can only be achieved when the equipment is connected to an equivalent receptaclemarked “HOSPITAL ONLY” or “HOSPITAL GRADE”. If the grounding integrity of the line cord or ACreceptacle is in doubt, operate on battery only.• Use only ECG cables (namely, ones with internal current-limiting resistors) specified or supplied byZOLL Medical Corporation to protect the M Series from damage during defibrillation, for accurate ECGinformation, and for protection against noise and other interference.WARNINGS (Continued)
  19. 19. General Information1-11FDA RegulationsTracking RequirementsU.S. Federal Law (21 CFR 821) requires the tracking ofdefibrillators. As an owner of this device, you have theresponsibility under this law to notify ZOLL MedicalCorporation if this product has been received; lost, stolenor destroyed; or has been donated, resold, or otherwisedistributed to a different organization.If any of the events described above occur, pleasecontact ZOLL Medical Corporation in writing with thefollowing information:1. Originators organization - Company Name, Address,Contact Name, and Contact Phone Number2. Part Number/Model Number and Serial Number3. Disposition of Device (e.g., received, lost, stolen,destroyed, distributed to another organization), NewLocation and/or Organization (if different from #1above) - Company Name, Address, Contact Name,and Contact Phone Number4. Date change took effect5. Other information or commentsPlease address your information to:ZOLL Medical CorporationAttn: Tracking Coordinator269 Mill RoadChelmsford, MA 01824-4105Fax: (978) 421-0010Tel: (978) 421-9655Notification of Adverse EventsAs a health care provider, you may have responsibilitiesunder the SMDA, for reporting to ZOLL and possibly tothe FDA the occurrence of certain events.These events, described in 21 CFR Part 803, includedevice related death and serious injury or illness. In anyevent, as part of our Quality Assurance Program, ZOLLshould be notified of any device failures or malfunctions.This information is required to assure that ZOLL providesonly the highest quality products.Warranty (U.S. Only)(a) ZOLL Medical Corporation warrants to the originalequipment purchaser that beginning on the date ofinstallation, or thirty (30) days after the date of shipmentfrom ZOLL Medical Corporations facility, whichever firstoccurs, the equipment (other than accessories andelectrodes) will be free from defects in material andworkmanship under normal use and service for theperiod of one (1) year. During such period ZOLL MedicalCorporation will, at no charge to the customer, eitherrepair or replace (at ZOLL Medical Corporations soleoption) any part of the equipment found by ZOLL MedicalCorporation to be defective in material or workmanship.If ZOLL Medical Corporations inspection detects nodefects in material or workmanship, ZOLL MedicalCorporations regular service charges shall apply. (b)ZOLL Medical Corporation shall not be responsible forany equipment defect, the failure of the equipment toperform any function, or any other nonconformance ofthe equipment, caused by or attributable to: (i) anymodification of the equipment by the customer, unlesssuch modification is made with the prior written approvalof ZOLL Medical Corporation; (ii) the use of theequipment with any associated or complementaryequipment, (iii) installation or wiring of the equipmentother than in accordance with ZOLL MedicalCorporations instructions. (c) This warranty does notcover items subject to normal wear and burnout duringuse, including but not limited to lamps, fuses, batteries,patient cables and accessories. (d) The foregoingwarranty constitutes the exclusive remedy of thecustomer and the exclusive liability of ZOLL MedicalCorporation for any breach of any warranty related to theequipment supplied hereunder. (e) Limitation of Liability:ZOLL shall not in any event be liable to Purchaser, norshall Purchaser recover, for special, incidental orconsequential damages resulting from any breach ofwarranty, failure of essential purpose, or under any otherlegal theory including but not limited to lost profits, lostsavings, downtime, goodwill, damage to or replacementof equipment and property, even if ZOLL has beenadvised of the possibility of such damages.THE WARRANTY SET FORTH HEREIN IS EXCLUSIVEAND ZOLL MEDICAL CORPORATION EXPRESSLYDISCLAIMS ALL OTHER WARRANTIES WHETHERWRITTEN, ORAL, IMPLIED, OR STATUTORY,INCLUDING BUT NOT LIMITED TO ANYWARRANTIES OF MERCHANTABILITY OR FITNESSFOR A PARTICULAR PURPOSE.For additional information, please call ZOLL MedicalCorporation at 1-800-348-9011. International customersshould call the nearest authorized ZOLL MedicalCorporation service center.
  20. 20. M SERIES OPERATOR’S GUIDE1-12Software LicenseNote: Read this Operators Manual and Licenseagreement carefully before operating any of theM Series products.Software incorporated into the system is protected bycopyright laws and international copyright treaties aswell as other intellectual property laws and treaties. Thissoftware is licensed, not sold. By taking delivery of andusing this system, the Purchaser signifies agreement toand acceptance of the following terms and conditions:1. Grant of License: In consideration of payment of the soft-ware license fee which is part of the price paid for thisproduct ZOLL Medical Corporation grants the Purchaser anon-exclusive license, without right to sublicense, to usethe system software in object-code form only.2. Ownership of Software/Firmware: Title to,ownership of and all rights and interests in thesystem software and all copies thereof remain at alltimes vested in the manufacturer, and Licensors toZOLL Medical Corporation and they do not pass toPurchaser.3. Assignment: Purchaser agrees not to assign, sub-license or otherwise transfer or share its rights underthe license without the express written permission ofZOLL Medical Corporation.4. Use Restrictions: As the Purchaser, you mayphysically transfer the products from one location toanother provided that the software/firmware is notcopied. You may not disclose, publish, translate,release or distribute copies of the software/firmwareto others. You may not modify, adapt, translate,reverse engineer, decompile, crosscompile,disassemble or create derivative works based on thesoftware/firmware.ServiceThe device does not require periodic recalibration oradjustment. Appropriately trained and qualifiedpersonnel should, however, perform periodic tests of thedevice to verify proper operation. (See GeneralMaintenance Section).U.S.A. CustomersShould the unit require service, it should be returned, inits original container, to:ZOLL Medical Corporation269 Mill RoadChelmsford, Massachusetts 01824-4105,Attn: Technical Service DepartmentLoaner instruments are available for use while repairsare being completed. To request loan equipment, contactthe ZOLL Technical Service Department at1-800-348-9011. Have the following informationavailable to expedite service:• The devices serial number• A description of the problem• Department where equipment is in use• Sample ECG strips documenting problem (if available)• A Purchase Order to allow tracking of loan equipmentInternational CustomersShould the unit require service, return it, in its originalcontainer, to the nearest authorized ZOLL MedicalCorporation service center.
  21. 21. General Information1-13Defibrillator Waveform InformationGeneralThe following defibrillation waveforms are produced when the device is discharged into 25, 50 and 100 ohm loads atmaximum energy. Each major vertical division equals 1000 volts; each major horizontal division equals 2 milliseconds.Discharge into a 25 ohm loadDischarge into a 50 ohm loadDischarge into a 100 ohm load
  22. 22. M SERIES OPERATOR’S GUIDE1-14ECG Analysis Algorithm AccuracySensitivity, specificity, false positive rate and positive predictivity are expressions of the accuracy of an ECG analysissystem when compared with clinicians or experts. The specifics of computations are detailed below. Theaccompanying data details the accuracy of the algorithm as tested by independent investigators.The Algorithm:• Divides the ECG rhythm into three 3-second segments.• Filters and measures noise, artifact, and baseline wander.• Measures baseline content (waviness at the correct frequencies- frequency domain analysis) of signal.• Measures QRS rate, width, and variability.• Measures amplitude and temporal regularity (auto-correlation) of peaks and troughs.• Determines if two-out of-three, 3 second segments are shockable then displays “SHOCK ADVISED” message.The Algorithm sequence takes approximately 9 seconds.Clinical Performance ResultsApplications: # of analyses # of patients316 194Shockable RhythmOverall Sensitivity 95.7%Positive Predictability100.0%Non-shockable RhythmOverall Sensitivity 100%False Positive Rate 0%Sensitivity = # of “correct shock” decisions by algorithmTotal # of rhythms for which a shock is clinically advisedSpecificity = # of “correct no shock” decisions by algorithmTotal # of rhythms for which no shock is clinically advisedFalse Positive Rate = # of “incorrect shock” decisions by algorithmTotal # of rhythms for which no shock is clinically advisedPositive Predictivity = # of “correct shock” decisions by algorithmTotal # of rhythms for which shock is advised by unit
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  76. 76. 3-1SECTION 3MANUAL DEFIBRILLATIONEmergency Defibrillation Procedure with PaddlesDetermine Patient Condition Following MedicalProtocolsVerify:• Unconsciousness• Absence of breathing• Absence of pulseBegin CPR following medical protocolsRequest additional assistance.1 Select DEFIBTurn the SELECTOR SWITCH to DEFIB. The unitautomatically defaults to 200 Joules or the first shockenergy selection pre-configured by the user.Note: Defibrillator “PADDLES” are selected as the ECGsource when the instrument is turned toMONITOR or DEFIB and paddles are connectedto the Multi-Function cable.Energy SelectObserve the display and verify the selected energy isappropriate. To change the energy setting use either pairof up-down arrow buttons. One pair is located on thefront panel of the unit, the other pair is located on thesternum paddle. The selected energy level will be shownas “DEFIB XXXJ SEL.” on the display.If the M Series unit is configured to do so, it automaticallysets the energy to the pre-configured Energy Level:Shock 1, 2, 3 setting at power-up and after each of thefirst two shocks. The “ENERGY INCREMENTED”message displays when this occurs. Manually changingthe energy level outside the pre-programmed sequenceand delivering a shock disables this function. Thisfunction is disabled when internal spoons are connected.See the M Series Configuration Guide for more details.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 allow electrolyte gel to accumulate on hands orpaddle handles.• When defibrillating with paddles use your thumbs to operate the SHOCK buttons in order toavoid inadvertent operator shock. No portion of the hand should be near the paddle plates.PACEROFFMONITOR DEFIB1DEFIB 200J SEL.ID#Param00:01ECGWave 2 AlarmsSyncOn/Off
  77. 77. M SERIES OPERATOR’S GUIDE3-2Note: Neonatal and Pediatric defibrillator energy levelsshould be set based on site-specific clinicalprotocols.Prepare PaddlesRemove the paddles from their holders by grasping thehandles and pressing down on the paddle release latchlocated above each paddle. Apply a liberal amount ofelectrolyte gel to the electrode surface of each paddle.(Use of electrode gel patches can be substituted for gelapplied to paddle surfaces.)Rub the electrode surfaces together to evenly distributethe applied gel.Apply Paddles to ChestApply the paddles firmly to the anterior wall of the chest.Place the “Sternum” paddle to the right (patient’s right) ofthe patient’s sternum, just below the clavicle.Place the “Apex” paddle on the chest wall, just belowand to the left of the patient’s left nipple, along theanterior-axillary line.Rub the paddles against the skin to maximize thepaddle-to-patient contactThe paddles may be used for ECG monitoring inemergency situations when time does not allowconnection of standard ECG monitoring electrodes. Theunit automatically pre-selects “PADDLES” when it isinitially turned on and paddles are connected to theMulti-Function cable.If an ECG cable and ECG electrodes are in use, pressthe LEAD button to select the desired ECG leadconfiguration - I, II, III or PADDLES (also aVR, aVF, aVLand V if the unit has been so configured).2 Charge DefibrillatorPress the CHARGE button on the front panel or on theapex paddle handle.If both SHOCK buttons on the paddles are depressedwhen the CHARGE button is activated, the device willnot charge and a “RELEASE SHOCK BUTTON” or othermessage will appear on the display.To increase or decrease the selected energy after theCHARGE button has been pressed, use the defibrillatorenergy select buttons on either the sternum paddle ordefibrillator front panel.After charging to the selected energy, the chargeindicator on the apex paddle will light. A distinctivecharge ready (continuous) tone sounds and the energyready “DEFIB XXXJ READY” message will be displayed.The defibrillator is now ready.3 Deliver SHOCKWARNING• Do not permit gel to accumulate between the paddleelectrodes on the chest wall (gel bridge). This couldcause burns and reduce the amount of energy delivered tothe heart.• If using defibrillator gel pads make sure that the size ofthe pad is large enough to cover the entire paddleelectrode area.3 SHOCK2 ANALYZECHARGEENERGYSELECTorSTERNUMAPEXCAUTION• Changing the selected energy while the unit is chargingor charged will cause the defibrillator to disarm itself.Press the CHARGE button again to charge the unit.WARNING• Warn all persons in attendance of the patient to STANDCLEAR prior to defibrillator discharge.• Do not touch the bed, patient, or any equipmentconnected to the patient during defibrillation. A severeshock can result. Do not allow exposed portions of thepatients body to come in contact with metal objects, suchas a bed frame, as unwanted pathways for defibrillationcurrent may result.3 SHOCK2 ANALYZECHARGEENERGYSELECTor
  78. 78. Manual Defibrillation3-3Using your thumbs, simultaneously press and hold bothSHOCK buttons (one on each paddle) until energy isdelivered to the patient.Once energy is delivered, the display will simultaneouslyshow “XXXJ DELIVERED” and “DEFIB XXXJ SEL”. Afterapproximately 5 seconds the “XXXJ DELIVERED”message will disappear and the “DEFIB XXXJ SEL”message remains to indicate the selected energy level.Note: If the defibrillator is not discharged within 60seconds after reaching the selected energy level,the unit automatically disarms itself.During the ten seconds prior to disarming, the chargeready tone will beep intermittently. The charge readytone will then stop, the charge indicator light will go off,and the monitor message will change to “DEFIB XXXJSEL.” Press the CHARGE button to recharge the unit.Paddle CleaningPaddle plates and handles must be thoroughly cleanedafter each use. See the General Maintenance Sectionfor correct cleaning procedure.CAUTION• Only use thumbs to depress the SHOCK buttons.Failure to do so could result in the inadvertentdepression of the ENERGY SELECT buttons, causingthe defibrillator to disarm itself.
  79. 79. M SERIES OPERATOR’S GUIDE3-4Emergency Defibrillation Procedure with MFE PadsDetermine Patient Condition Following MedicalProtocolsVerify:• Unconsciousness• Absence of breathing• Absence of pulseBegin CPR following medical protocolsRequest additional assistance.Prepare PatientRemove all clothing covering the patients chest. Drychest if necessary. If the patient has excessive chesthair, clip it to ensure proper adhesion of electrodes.Attach the Multi-Function Electrode (MFE) Padsaccording to instructions on the electrode packaging.Ensure that all MFE Pads are making good contact withthe patient’s skin and are not covering any part of theECG electrodes.Connect MFE Pads to the multi-function cable if notpreconnected.The messages “CHECK PADS” and “POOR PADCONTACT” will be alternately displayed and energy willnot be delivered if the MFE Pads are not making goodcontact with the patientThe message “DEFIB PAD SHORT” will be displayed toindicate that a short circuit between MFE Pads mayexist.MFE Pad Application1. Apply one edge of the pad securely to the patient.2. “Roll” the pad smoothly from that edge to the otherbeing careful not to trap any air pockets between thegel and skin.Note: If it is not possible to place the “BACK” MFE Padon the patients back, the MFE Pad should beplaced in the standard apex-sternumconfiguration. Effective defibrillation will result,but pacing with the device will usually be lesseffective.1 Select DEFIBTurn the SELECTOR SWITCH to DEFIB. The unitautomatically defaults to 200 Joules or the first shockenergy selection pre-configured by the user.Note: Multi-function “PADS” are selected as the ECGsource whenever the instrument is turned toMONITOR or DEFIB and paddles are notconnected to the Multi-Function cable. You mayselect any of the other ECG lead configurations -I, II, III (also aVR, aVF, aVL and V) if the unit hasbeen so configured and ECG cable/electrodesare in use.Paddles are a defibrillation protected Type BF patient connection.ECG leads are a defibrillation protected Type CF patient connectionWARNING• Poor adherence and/or air under the MFE Pads can leadto the possibility of arcing and skin burns.PadSkinPACEROFFMONITOR DEFIB1DEFIB 200J SEL.ID#Param00:01ECGWave 2 AlarmsSyncOn/Off
  80. 80. Manual Defibrillation3-5Energy SelectObserve the display and verify the selected energy isappropriate. To change the energy setting use either pairof up-down arrow buttons. One pair is located on thefront panel of the unit, the other pair is located on thesternum paddle. The selected energy level will be shownas “DEFIB XXXJ SEL.” on the display.If the M Series unit is configured to do so, it automaticallysets the energy to the pre-configured Energy Level:Shock 1, 2, 3 setting at power-up and after each of thefirst two shocks. The “ENERGY INCREMENTED”message displays when this occurs. Manually changingthe energy level outside the pre-programmed sequenceand delivering a shock disables this function. Thisfunction is disabled when internal spoons are connected.See the M Series Configuration Guide for more details.Note: Neonatal and Pediatric defibrillator energy levelsshould be set based on site-specific clinicalprotocols.2 Charge DefibrillatorPress the CHARGE button on the front panel.To increase or decrease the selected energy after theCHARGE button has been pressed, use the defibrillatorenergy select buttons on the front panel.After charging to the selected energy, the SHOCK buttonon the front panel will light. A distinctive charge ready(continuous) tone sounds and the energy ready “DEFIBXXXJ READY” message will be displayed. Thedefibrillator is now ready.3 Deliver SHOCKPress and hold the SHOCK button on the front paneluntil energy is delivered to the patient.Once energy is delivered, the display will simultaneouslyshow “XXXJ DELIVERED” and “DEFIB XXXJ SEL”. Afterapproximately 5 seconds the “XXXJ DELIVERED”message will disappear and the “DEFIB XXXJ SEL”message remains to indicate the selected energy level.Note: If the defibrillator is not discharged within60 seconds after reaching the selected energylevel, the unit will automatically disarm itself.During the ten seconds prior to disarming, the chargeready tone will beep intermittently. The charge readytone will then stop, the SHOCK button light will go off,and the displayed message will change to “DEFIB XXXJSEL.” Press the CHARGE button to recharge the unit.CAUTION• Changing the selected energy while the unit is charging orcharged will cause the defibrillator to disarm itself. Pressthe CHARGE button again to charge the unit.3 SHOCK2 ANALYZECHARGEENERGYSELECT3 SHOCK2 ANALYZECHARGEENERGYSELECTWARNING• Warn all persons in attendance of the patient to STANDCLEAR prior to defibrillator discharge.• Do not touch the bed, patient, or any equipmentconnected to the patient during defibrillation. A severeshock can result. Do not allow exposed portions of thepatients body to come in contact with metal objects, suchas a bed frame, as unwanted pathways for defibrillationcurrent may result.3 SHOCK2 ANALYZECHARGEENERGYSELECT
  81. 81. M SERIES OPERATOR’S GUIDE3-6Open Chest Defibrillation with Internal Handles and ElectrodesZOLL Autoclavable Internal Handles are designed for use with a manually operated ZOLL defibrillator and internaldefibrillation electrodes to defibrillate the heart during open chest surgical procedures.When used with a ZOLL defibrillator equipped with an advisory or ECG analysis feature, the ZOLL AutoclavableInternal Handles allow the defibrillator to operate only as a manual device.Connection of the ZOLL Internal Handle Sets to the defibrillator automatically causes the defibrillator to limit its energyoutput to a maximum of 50 joules.Refer to the Autoclavable Internal Handle and Electrode Operator’s Guide for step by step open chestdefibrillation procedure and important cleaning and sterilization information.TroubleshootingIf your M Series unit does not function as expected, see the Defibrillator Troubleshooting section starting on page B-5.
  82. 82. 4-1SECTION 4ADVISORY DEFIBRILLATIONAdvisory DefibrillationThe device can identify shockable rhythms using its builtin ECG analysis capability when using MFE Pads tomonitor ECG and defibrillate. The operator must read theadvisory messages, charge the defibrillator to the userselected or preconfigured energy level (if automaticcharge is disabled), and deliver treatment to the patientwhen required by protocol and patient condition.The Advisory function can only be activated when:• MFE Pads are connected and selected as the ECG source• MFE Pads are firmly attached to the patient to reduce anyelectrode noise or artifactand• SELECTOR SWITCH is turned to DEFIB.Determine Patient Condition Following Medical ProtocolsVerify:• Unconsciousness• Absence of breathing• Absence of pulseBegin CPR following medical protocolsRequest additional assistance.Prepare PatientRemove all clothing covering the patients chest. Drychest if necessary. If the patient has excessive chesthair, clip it to ensure proper adhesion of electrodes.Attach the MFE Pads according to instructions on theelectrode packaging.Ensure that all MFE Pads are making good contact withthe patient’s skin and are not covering any part of theECG electrodes.Connect MFE Pads to the multi-function cable if notpreconnected.The messages “CHECK PADS” and “POOR PADCONTACT” will be alternately displayed and energy willnot be delivered if the MFE Pads are not making goodcontact with the patient.The message “DEFIB PAD SHORT” will be displayed toindicate that a short circuit between MFE Pads mayexist.MFE Pad Application1. Apply one edge of the pad securely to the patient.2. “Roll” the pad smoothly from that edge to the otherbeing careful not to trap any air pockets between thegel and skin.Note: If it is not possible to place the “BACK” MFE Padon the patients back, the MFE Pad should beplaced in the standard apex-sternumconfiguration. Effective defibrillation will result,but pacing with the device will usually be lesseffective.When Multi-function Electrode (MFE) Pads are used the patientconnection is considered to be defibrillation protected Type BF.WARNING• Do not use the unit’s Advisory function on patients under8 years of age.WARNING• Poor adherence and/or air under the MFE Pads can lead tothe possibility of arcing and skin burns.PadSkin

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