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PIC30 User`s Manual

1. Supr Diagnostics SW Rev Menu Options Available Adv Biphasic Pacer Add Advisory Add Add Pacer Option Biphasic Option Option Welch Allyn PIC30 Operating Instructions Program Menu Setup Supervisor Defibrillator Menu Supervisor Defib Pacer Setup Diag Alarms Exit optional Supr Defib Mode Ext Eng Int Eng Alarm Ext Energy Int Energy CV Mode Alarm Menu Menu Menu Menu Ext Energy External Energy Menu The external energy menu sets the default energy selected when the PIC30 is first turned on with external paddles connected The default selected energy setting is displayed in this menu To change the default energy setting press either the up arrow to increase or down arrow to decrease energy selection Available options are 2 5 7 10 20 30 50 70 100 150 200 300 or 360 Joules Press Exit to return to the Supervisor menu Internal Energy Menu The internal energy menu sets the default internal energy selected E SO when the PIC30 is first turned on without paddles or when internal paddles are first attached The current selected default energy setting is Joules displayed in this menu To change the default energy setting press either the up arrow to increase or down arrow to decrease energy selection Available options are 2 3 4 5 6 7 8 9 10 20 30 or 50 Joules To prevent possible cardiac tissue damage the ene
2. 7 Press the up or down ENERGY Verify that the energy graph is select arrow to select 200 Joules on displayed on the right side of the the defibrillator display and that 200J has been selected 8 Press the CHARGE button on the Verify that the energy graph front panel or on the deluxe apex paddle highlights as it charges up to 200J A periodic tone will sound while the defibrillator is charging At the completion of the charge cycle the tone will be constant and the energy graph will fill up to and include 200J The charge time should be less than 7 seconds for SmartPak batteries 9 seconds for SuperPac batteries or 15 seconds if no battery is installed Welch Allyn PIC30 Operating Instructions 11 5 Maintenance and Service WARNING Keep hands and fingers away from paddle electrodes 9 Ensuring the paddles are properly applied to the test contacts press only the sternum paddle button and release Then press only the apex paddle button and release 10 Press both the sternum and apex paddle buttons Return the paddles to their holder The defibrillator should not discharge The defibrillator should discharge and the defibrillator test light on the top of the paddle tray must flash indicating defibrillator discharge Verify that the Del Energy in the Defib window is between 180 J and 220 J 11 Press the SYNC button The Defib window should indicate Sync and the Sync Indicator
3. Multiple Paired Contacts Recharge Rate 2s Run Time on Battery Power Full Energy Shocks Battery Life Data Retention Battery Data Retention Battery Life Pacer Optional Type Pacer Rate 6 seconds Automatically set to monitor s frequency response Records defibrillation pacing and status events Automatically logs into memory the type of event time and ECG sample 28 ECG events or 300 non ECG events Manual and automatic User selectable Grid On Off 100 to 240 VAC 10 auto ranging 50 to 60 Hz 5 Monitoring Only 12W typical Maximum 190W User replaceable Nicad 12 volt SmartPak SmartPak or SuperPac Audible tone chart printout if automatic printing enabled and low battery icon on display Audible tone repeats every 2 minutes Audible tone and flashing low battery icon on display 1 minute before shutdown Insures quick error free insertion and backup reliability lt 3 hours to 80 4 hours to 100 for SmartPak 3 5 hours to 80 4 5 hours to 100 for SmartPak 7 5 hours to 80 9 5 hours to 100 for SuperPac 2 Hours monitoring only for SmartPak 2 5 Hours monitoring only for SmartPak 5 Hours monitoring only for SuperPac gt 40 360J for SmartPak gt 60 360J for SmartPak gt 110 360J for SuperPac 5 Years External transcutaneous pacing 30 to 180 BPM 5 Welch Allyn PIC30 Operating Instructions 12 5 Specifications Out
4. Load Ohms Ip Amps t ms 25 53 1 10 0 50 27 1 18 8 100 13 7 36 4 Wayeform uou ed xa eei e edes Truncated Exponential Biphasic where available Waveform Details 2 360 joules Patient Phase 1 Phase 2 Tilt 96 Resistance Duration ms Duration ms Min Max Min Max Min Max 25 5 1 6 3 2 4 6 74 8 82 9 50 6 8 7 9 4 9 5 6 639 71 100 8 6 10 6 5 8 7 1 50 7 56 5 125 9 5 11 2 6 3 7 4 46 3 51 6 Energy Select sss sa sh acides E ERR RA 2 5 7 10 20 30 50 70 100 150 200 300 360 J Core MING Ze rd tamil aed 7 seconds 360 with a SmartPak Plus battery after 15 discharges lt 9 seconds 360 with a SuperPac battery after 15 discharges lt 15 seconds 360 AC power 90 voltage or battery power after 15 max energy discharge Charpe Indicator iier or ee hoa Audible and graphic Periodic tone while charging continuous tone while charged 12 2 Welch Allyn PIC30 Operating Instructions Specifications OUTPUTS e sii epope bees E eed Adult paddles internal paddles pediatric adapter and multipurpose hands free adapter available Synchronizer seses dee eer A Delivers energy within 60 msec of R wave detection Disarm auer daw ae see eileen Front panel switch or auto after 60 seconds Indication Charged tone pitch increases with 10 seconds remaining then stops on disarm Tester optional ss dree Sek ad Integrated defibrillator tester in paddle tray verifies defibrillator output gt 2
5. QRS Beeper Control The quick access ORS beeper control turns the beeper on and off Beeper OFF qi Beeper ON d Calibration Control The quick access calibration control is used to send a calibration signal to the monitor and chart recorder Note Cal button is disabled in x4 gain setting Auto Heart Rate Control The quick access auto heart rate HR control is used to set the automatic HR alarm The auto HR icon appears only if auto is selected in the HR alarm menu See page 3 3 for HR alarm menu 2 6 Welch Allyn PIC30 Operating Instructions Control Panel and Display In order to set the auto HR alarm limits 1 There must be a valid heart rate displayed in the HR window 2 Auto HR alarm must be selected in the HR alarm configuration menu 3 Global alarms must be enabled To set the automatic HR alarm limits press the quick access button The patient s Setting auto heart rate alarm heart rate at the moment the button was pressed will be displayed above the heart The P 60 BPM T lia an M monitor automatically sets the upper and lower laim selected heart rate alarms at 20 of that heart rate set point or 10 beats Each press of the button will adjust the heart rate set point and reset the auto HR alarm limits 2 Global alarms enabled If an alarm parameter is exceeded an audible tone will sound and the heart rate will flash 3 Press auto HR alarm to set auto HR limits
6. A Energy Select v Understanding the Defibrillator Controls and Display o cme nl Sync Disarm J A 18 2 Welch Allyn A Eg PIC30 aa xd 5 BG Size Lead cl D j a MONITOR C BELL LLLLI ZS cl Ir E56 KS X p E 1 DEFIBRILLATOR gt A PACING Selected Er A PACER Mode S7 Rate ao Dn Le a 200 Energy pacer O 75 0 mun 5 mmm m J Select 2 3 onion sta amer en es em log Sample 3 j iva Disarg Se CCCII JI Waveform Defibrillator Energy Charge window window Defibrillation functions on the PIC30 are viewed on and controlled by the areas indicated above Note The following operations of the defibrillator depict normal factory default settings Later in this chapter we will discuss user configurations of the defibrillator Initial defibrillator display upon unit startup When the PIC30 is turned on the selected energy default is displayed The defibrillator is not charged CONNECT PADDLES in the defibrillator window indicates the defibrillator paddles multipurpose hands free adapter or internal paddles are not attached or are not seated firmly in the defibrillator connector Energy Selection Control and Display The button is used to select defibrillator energy Pressing either the up or down arrow will cause the Energy Range Bar to be displayed on the right side
7. anterior axillary line V6 Same transverse level as V4 at left mid axillary line Welch Allyn PIC30 Operating Instructions 5 3 ECG Monitoring 5 4 Monitoring with Hands Free Defibrillation Pads optional CAUTION Be sure that the hands free adapter is firmly seated in the defib connector before monitoring with hands free defibrillation pads CAUTION Use only Welch Allyn approved multifunction pads with PIC30 hands free adapter Do not connect unapproved ECG sets to the PIC30 hands free adapter an ECG will not be obtained Multipurpose hands free connector 1 Press switch on Press the Button to the PAD position 2 Connect the disposable defibrillation pads to the hands free adapter cable 3 Remove or loosen clothing if necessary for application of pads Clean and dry skin sites preferably with a coarse dry terry cloth 4 Check expiration date on the multipurpose pads package if the expiration date has passed do not use the pads Remove the multipurpose defibrillation pads from packaging Remove the protective cover and apply the pads to the patient in the position HANDS FREE PAD PLACEMENT illustrated here Do not use if gel area is dry 5 When applying pad gently adhere opposite edge of pad to patient and lightly roll pad against patient s skin 6 Observe the patient s electrocardiogram on the monitor scope 7 Adjust control as necessary Note Apex anterior or
8. gt Volume a The quick access buttons are dt t e 1 OS pas gt GLOBAL Alarm both the quick access features shown at right and to navigate through menu pop up D QRS Beeper Icon d J windows see chapter 3 gt eegen Kat JL gt Auto Heart Rate e Da Advisory Function if installed QUICK ACCESS FEATURES Volume Control The quick access volume control increases and decreases the volume of the PIC30 There are four volume settings that can be selected Each press of the the button increments the volume to the next level The volume ramp 21 indicates the volume level selected Global Alarm Control The quick access global alarm enables or disables all set alarm parameters When the PIC30 is turned on the global alarm will default to the last setting at system shutdown either enabled 44 or disabled 4X To enable global alarms press the button 1 to display the alarm on icon A With the global alarms enabled any set alarm parameter will be enabled 9 To disable global alarms press the button two times The first press of the button 2 will change the icon to PUSH TO DISABLE The second press 3 will change the alarm icon to OFF A If the button is not pressed a second time within 10 seconds global alarms will automatically revert to enabled With the global alarm disabled all parameter alarms will be disabled v v v v y y
9. Press to turn pacer on the pacer window will become active The pacer indicator next to the Pacer button will illuminate orange indicating that the pacer is stopped and that no pacer pulses are being delivered to the patient Note When the pacer is on the lead selection will be restricted to Leads I II or III Press button to select the desired pacing rate Note The initial pacing output rate can be set in the pacing supervisor menus Press the button to select the appropriate therapy Each time the MODE button is pressed the pacing mode will change between demand and async mode The selected mode will be displayed in the pacing window Note The initial pacing mode can be set in the pacing supervisor menus Welch Allyn PIC30 Operating Instructions External Pacing In Demand Mode pacing pulses will be inhibited by the patient s QRS complexes that occur during a time interval that is dependent on the setting of the rate control If during that interval no QRS complexes occur a pacing pulse will be delivered to the patient In the demand mode the pacer supplies the required number of pacing pulses to maintain the patient s heart rate at approximately the rate selected in the pacing rate window Due to the delay between delivered pacing pulse and the patient s response the heart rate display may read less than what is selected on the pacer rate window How much less will depend on the time it takes the heart to respond to t
10. Warnings Cautions and Notices WARNINGS WARNING If conductive gel forms a continuous path between the defibrillator electrodes delivered energy to the heart muscle may be dramatically reduced resulting in ineffective defibrillation In this case remove the gel by wiping the surface of the body and reposition the electrodes to eliminate the shunting path before attempting additional shocks WARNING The PIC30 can deliver 360 joules of electrical energy If proper defibrillation protocol is not followed as described in this manual the electrical energy could cause personal injury or death to the operator or a bystander WARNING During defibrillation discharge the operator and all other people must not contact the patient the bed or any other conductive surfaces that are in contact with the patient The electrical energy delivered to the patient could also be shunted to any other person who is in contact with the patient or the conductive surface WARNING Do not use the defibrillator in the presence of oxygen sources such as bag valve mask devices or ventilators flammable gases or anesthetics These environments can produce fire or explosion hazards Remove all oxygen sources from the patient vicinity before discharge WARNING Electrical shock hazard DO NOT contact the patient during defibrillation Otherwise serious injury or death could result WARNING NEVER position defibrillator paddles very close to or over ECG sensors
11. Welch Allyn Portable Intensive Care System PIC30 a KRELL User Instruction Manual Welch Allyn Part Number 991022 Revision C WelchAllyn Portable Intensive Care System USER INSTRUCTION MANUAL Model PIC 30 Software Revision W Medical Research Laboratories Inc a Welch Allyn Company 1000 Asbury Drive Buffalo Grove Illinois 60089 847 520 0300 Telephone 800 462 0777 Toll Free 847 520 0303 Fax www welchallyn com Internet 1998 1999 2000 2001 2002 2003 2004 MRL Inc a Welch Allyn Company All rights reserved Printed in the U S A Welch Allyn Part Number 991022 Revision C Forward FDA Medical Device Registration Foreword This manual is intended to provide information for the proper operation of the Welch Allyn PIC 30 DO NOT ATTEMPT TO USE THIS EQUIPMENT WITHOUT THOROUGHLY READING AND UNDERSTANDING THESE INSTRUCTIONS USER S RESPONSIBILITY The user is required to be trained in basic monitoring vital signs assessment and emergency cardiac care As with all other electronic patient care monitors good clinical judgment should be used when operating the Welch Allyn PIC The user should be completely knowledgeable of the information in the User Instruction Manual User must save all shipping containers and packaging materials When shipping the PIC System and accessories for calibration service or upgrades the original shipping containers and packaging materia
12. w ERRE If there is no heart rate in the HR window the upper and lower heart rate limits will be undetermined and the set heart rate icon e will appear Advisory Control Optional The A icon control will appear if the advisory option has been installed and enabled To initiate an ECG analysis cycle follow the instructions below 1 Stop CPR and stand clear of the patient 2 Press the A icon The trace section of the screen will be reformatted with the ECG trace in the upper half and the advisory prompts in the lower half If good patient electrode contact is detected an Analyzing prompt will be displayed Within 4 16 seconds a Shock Advised or No Shock Advised prompt will be displayed The A icon will remain highlighted during the duration of the analysis cycle The split screen and prompts will remain for 12 seconds after the completion of the analysis cycle Pressing the A icon control again while the split screen is displayed will abort the analysis cycle and return the trace to its normal configuration Note All personnel must stand clear of the patient during the duration of the analysis cycle Only use the advisory option to analyze ECG on pulseless apneic motionless patients Note The Lead Select and Size controls will be locked out during analysis The PIC30 will automatically select lead II or Pads and will set the size to 1 cm mvV Note The Advisory contr
13. 14 Welch Allyn PIC30 Operating Instructions Program Menu Setup Set Code 4 3 4 Print Options Alarm O Defib Pacer O O n ECG Events n Miscellaneous On t Code Menu The default access code for supervisor configurations is 1 2 3 4 To set a new supervisor code enter the numbers of your choice 0 9 in all four number areas To cancel the number code selection press Cancel to save your code press Enter Note Be sure to write down the new supervisor code in a safe place Printer Menu The printer menu allows the supervisor to disable hardcopy printouts when specific events occur Setting the selections in the printer menu to Off will disable printouts for those events at the time the event occurs Chart printouts for these events can only be obtained when the event log is printed Selections set to On will generate printouts both at the time the event occurred and when the event log is printed ECG Events are events generated by pressing the Sample button Miscellaneous events are system status events such as System On and Low Battery messages Lead Menu The lead menu allows the supervisor to change the default lead displayed on the start up Welch Allyn PIC30 Operating Instructions 3 15 Program Menu Setup Supervisor Upgrade Menu Options Available Adv Biphas Pacer Advisory Bipasic Pacer option pass option pass option pass ADV Password
14. 8 ae ra RE RR 4 1 Preparing Patients for BCC 4 2 Applying ECG Sensors ies ene d a ose Saw agen etd 4 3 Using Disposable ECG Sensors rypene ocen y i a a e a 4 3 ECG Monitoring 05 xx eere X CHOU Ew e E e REV o 5 1 Monitoring with Defibrillator Paddles ee eee EN 5 2 Monitoring with 3 Lead Patient Cable EENS ENEE ena 5 2 Monitoring with 5 Lead Patient Cable 0 00 cece eens 5 3 Monitoring with Hands Free Defibrillation Pads optional 5 4 Welch Allyn PIC30 Operating Instructions Table of Contents Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Defibrillation aa e hh heme x Re RR enw 6 1 Defibrillation with External Paddl s i e sooo hr Rr 6 2 Defibrillation with Pediatric Adapter iilii sse edendi mee hn 6 3 Defibrillation with Multipurpose Hands Free Pads optional 6 4 Performing Synchronized Cardioversion c c uecessscar eee pe erg 6 5 External PACING Ae gc CER GEO on i es CR OPE OC 7 1 External Pacer Operation Procedures optional 7 2 Event Documentation lt 4 65 65504449 eR ERES S ACCES 8 1 Chart Recorder Startup Printout sieisen dere I Er ERE 8 2 Turning On Off the Chart Recorder ubertas eer her Reo n 8 3 A tomatic Printing sesi solo seke nisasie eg UE REC LAYERS Keep Sb sr 8 4 Event log Surmmlaty AE os er ene dere dE C ERE Zeg 8 5 Porver SOUICE css pua quedo awed rna IEEE Ron RAO angu 9 1 General Precautions 1 cect yeaa
15. Async mode PACING 60 BPM 30 MA DEMAND PACING PACER STOP 60 BPM 30 MA DEMAND PACING STOPPED paused Control Panel and Display y Alarm Understanding the Menu Controls The menu controls and functions are controlled by and viewed in the areas indicated below Initial menu items displayed upon unit startup When the PIC30 is powered on the initial startup menu is displayed Pressing any of the menu controls under the function displayed will allow the operator to setup the PIC30 according to their preferences The PIC30 menus are discussed in detail in the next Chapter T E WelchAllyn AT E PIC30 simo E pm Size Lead C BSLLLJALLL eem J pl RH v ES Hold p H p amp DEFIBRILLATOR A pj A i o PACER e mmm Selected Energy A Syne Mode Rate mp mA jam GE i PAGER O Een EE DEMAND F 200 Ta 2 onat StariStop oup Cm mm 3E SZ osam 2 El IG g VK PIC30 Setup Log Sample Xi Welch Allyn PIC30 Operating Instructions 2 13 Chapter Program Menu Setup Basic Menu Structure i c eise ed be e enan b a eee eee 32 PIC30 Menu Heart Rate Alarm 3 3 PIC30 Menu Log Menu Sample and Bright Functions 3 5 Setup Menu ECG Configuration Menus 3 6 Setup Menu Grid Time Date and Supervisor Code Menus 3 8 Overview of Supervisor Men
16. Lead Fault The pads lead fault indicates that the multipurpose hands free ee adapter has not been installed or that the multipurpose pads oe have not been attached to the patient or multipurpose hands free adapter To correct fault install the multipurpose hands free adapter and connect the hands free pads to the adapter and patient ECG Lead Fault Pacer Fault The ECG lead fault occurs when lead wires are not properly ECG Lead Fault connected to the ECG electrodes To correct fault confirm the DEMAND ECG lead wires are attached to the ECG electrodes and the electrodes are properly applied to the patient Welch Allyn PIC30 Operating Instructions 2 11 Control Panel and Display Lead Selector Fault This display indicates that the lead selector is not set to leads I II or III Select lead I II or III to allow pacing Pacer Controls O PACER On Off NZ Rate A NZ Output N Start Stop Pacer Control Pressing the pacer button activates the pacer but does not deliver pulses The initial pacing parameters will be displayed in the pacing window Pressing the button again will turn off the pacer Note When the pacer is on and the defibrillator has been charged the pacer will automatically be turned off for safety reasons Mode Control Pressing the button changes the pacing mode from demand to async mode The selected mode will be displayed in the pacing window Note The initial pacing mode can be set
17. Note The initial pacing output rate will automatically be set to the lowest current output to prevent accidental high currents from being delivered to the patient External transcutaneous pacing may be uncomfortable for certain patients Depending upon local protocol consider administering a sedative or analgesic should the pacing therapy become uncomfortable 15 To stop pause the delivery of pacing pulses momentarily press the button The pacing display will indicate Pacer Stop and the pacing indicator light will change from green to orange The rate and output settings will remain the same as what was selected prior to the Start Stop button being pressed To re initiate pacing press the button again Note Should the patient require defibrillation during pacing follow the defibrillation procedure as outlined in chapter 6 When the defibrillator is charged the pacer will automatically be turned off for safety reasons If a Lead Fault occurs the display will indicate the faulting leads ECG or pads During lead fault conditions the pacer light will illuminate red to caution the operator that a lead fault condition exists In an ECG Lead Fault condition check that the ECG electrodes and patient cable are connected properly In a Pads Lead Fault condition Welch Allyn PIC30 Operating Instructions 7 3 External Pacing check to see that the multipurpose electrodes and multipurpose hands free adapter are connected properly When th
18. SHIFT CHECKLIST Date Shift Location Mfr Model No Serial No or Facility ID No At the beginning of each shift inspect the unit Indicate whether all requirements have been met Note any corrective actions taken Sign the form Okay as found Corrective Action Remarks 1 Defibrillator Unit Clean no spills clear of objects on top casing intact 2 Paddles including pediatric adapters a Clean not pitted Release from housing easily If internal paddles are included verify their availability in a sterile package Periodically inspect as with external paddles 3 Cables Connectors a Inspect for cracks broken wire or damage b Connectors engage securely 4 Supplies a Two sets of pads in sealed f Razor packages within expiration date Monitoring electrodes g Spare ECG paper Spare charged battery available Alcohol wipes Hand towels Cassette tape j Gel or other conductive medium present Scissors and stored properly 5 Power Supply a Battery powered units 1 Verify fully charged battery in place 2 Spare charged battery available 3 Follow appropriate battery rotation schedule per manufacturer s recommendations b AC Battery backup units 1 Plugged into live outlet and maintain battery charge 2 Test on battery power and reconnect to line power 6 Indicators ECG Display a Power On display b Self test OK c Monitor display functional d Service message display off
19. adhesive for good results Disposable sensors should be stored according to the guidelines on the packaging and should not be used after the expiration date Never mix sensor types or brands Incompatibilities can cause baseline drift and can increase trace recovery time after defibrillation or cause unstable baseline Welch Allyn PIC30 Operating Instructions 4 3 Patient Preparation Applying Chest Sensors 1 Expose the chest 2 Locate the electrode positions on the patient s chest see illustration below 3 Apply the sensors 4 Ensure that the leads conform to body contours and that no strain is placed on the sensors 3 LEAD ELECTRODE PLACEMENT Color lead Location AHA IEC Right mid clavicular line between 6th Green RL Black N and 7th intercostal space Red LL i Green F Left mid clavicular line between 6th and 7th intercostal space White RA Red R Right mid clavicular line directly below i clavicle Black LA Yellow L Left mid clavicular line directly below i clavicle Brown V White C Chest Place per figure at left for V1 V6 V1 4th Intercostal space at right sternal margin V2 4th Intercostal space at left sternal margin V3 Midway between V2 and V4 leads V4 5th Intercostal space at mid clavicular line V5 Same transverse level as V4 at left anterior axillary line V6 Same transverse level as V4 at left mid axillary line PEDIATRIC LEAD PLACEMENT W
20. coarse dry terry Red Yellow cloth Next clean skin with alcohol and R L allow to dry completely before applying ads Red ud LL Note The type of electrode and the or technique used in preparing the skin are Green major factors in determining the quality F of the ECG signal obtained Use high quality silver silver chloride electrodes These electrodes are designed to provide excellent baseline stability rapid recovery from defibrillation and minimize artifact from patient movement Do not use electrodes if gel is dry 4 Connect each lead of the 3 lead patient cable to the appropriate electrode Arrange the electrodes as shown above Make sure that the ECG electrodes are placed to allow defibrillation if necessary 5 Insert the patient cable plug into the input ECG connector on the PIC30 6 Select the proper lead setting for the desired lead configuration by pressing the button to the appropriate position I II or III 7 Observe the patient s electrocardiogram on the display Adjust size of the ECG trace with the button as necessary 5 2 Welch Allyn PIC30 Operating Instructions ECG Monitoring Monitoring with 5 lead Patient Cable 1 Press switch on 2 Insure that the display indicates a 5 lead patient cable has been configured If not see page 3 7 for setting patient cable 3 Thoroughly prep patient skin for electrode attachment Clean and dry skin sites preferably with a coarse dry ter
21. e Battery charging low battery light off f Correct time display set with dispatch center 7 ECG Recorder a Adequate ECG paper b Recorder prints 8 Charge Display Cycle for Paddle or Adhesive Pad Defibrillation Disconnect AC plug battery backup units Charge to manufacturer s recommended test energy level Charge indicators working Discharge per manufacturer s instructions Reconnect line power a Pacer output cable intact b Pacer pads present set of two c Inspect per manufacturer s operational guidelines Major problem s identified OUT OF SERVICE Applicable only if the unit has this supply or capability Signature Maintenance and Service Cleaning and Disinfecting the PIC30 Clean and disinfect the unit any time it is deemed necessary THE ENCLOSURE Use only the recommended cleaning agents listed below Warm water Hydrogen peroxide solution Coverage Liquid soap Wex cide Formula 409 Fantastik Windex T B Q INCIDIN Never use these cleaning agents Butyl alcohol Denatured ethanol Freon Mild chlorine bleach solution Isopropyl alcohol Trichloroethane trichloroethylene Acetone Vesphene II Enviroquat Staphene Misty Glutaraldehyde Ether Benzene CLEANING Apply the cleaning solution to a clean soft cloth and gently rub the outer enclosure CAUTION Do not immerse the PIC30 or apply liquids direc
22. every 30 minutes or less 4 When the battery runs out note the time This will give you a duration of time that relates to the current battery capacity Compare this run time to the value given in the table above that corresponds to the battery type being used Acceptable Results Battery run time must meet or exceed the minimum time given table above Recharge the battery connect AC power and allow the battery to fully charge or insert the battery in the Welch Allyn Quick Charger Corrective Action If the operating time is less than the specified time above repeat the test to determine if reconditioning was effective If the operating time remains short remove the battery from service and replace it Verify that the battery is fully charged and the correct battery type has been selected on the table above prior to the capacity test Welch Allyn PIC30 Operating Instructions 11 3 Maintenance and Service Consider the age of the battery and the frequency of its use The recommended replacement interval in this critical application is every 2 years as indicated on the battery label Due to the critical nature of battery packs replacement of the battery is recommended every 24 months Do not use the battery after the Do Not use after date labeled on the battery pack DEFIBRILLATOR TESTING The PIC30 paddle holder and the Welch Allyn Quick Charger contain a defibrillator testers for verifying the operation of the PIC30
23. exercised If an additional conditioning cycle is desired press the push button again Allow the battery to remain in the charger until the yellow battery light begins to flash again The time required for the discharge cycle to be completed varies depending on battery capacity and state of charge A fully charged battery with normal capacity will require approximately 8 hours to discharge in the reconditioning slot and a high capacity battery will require 18 hours Partially discharged batteries will require less time After the discharge portion of the reconditioning cycle has been completed the battery pack will undergo a normal charging cycle BATTERY TESTS It is important to test the batteries every 90 days to determine battery capacity for monitoring This will help you approximate the amount of time available for monitoring when the battery icon is displayed ICONS F AUX When the PIC30 is operating from battery power only a battery icon will be displayed on the unit to give a rough estimate of the remaining capacity of the battery Aux Power This icon will appear whenever the PIC30 is operating from AC line power Battery This icon will appear whenever the AC line power is disconnected and the PIC30 is running from the battery Note The battery icon gives the operator a rough estimate of remaining battery capacity of an inserted battery Through proper maintenance of the battery you can determine approxim
24. for each group The mean impedance for these animals was 62 ohms The mean ED50 energies were compared and 12 8 Welch Allyn PIC30 Operating Instructions Specifications were found to be significantly different The significance of difference p value was calculated by the Wald test in each case and are shown below The mean ED50 peak current for the biphasic waveform was 39 percent of that required with the MDS waveform Summary Table ED50 amp ID50 Mean Welch Allyn PIC Monophasic Biphasic Damped Sine ID50 Peak Current Significance of difference p value ED50 Delivered Energy Joules Significane of difference p value Conclusion The MRL Orbital Biphasic waveform is capable of converting fibrillation episodes using less energy than the MDS waveform and requires lower peak currents than MDS waveform defibrillators STUDY 2 Objective Comparison of the defibrillation effectiveness of the MRL Orbital Biphasic waveform defibrillator with a commercially available Biphasic 2KV defibrillator capable of 360 J and a monophasic truncated exponential defibrillator Methods A canine model n 6 61 6 5 5 Ibs was used in a study that was approved by the Institutional Animal Care and Use Committee The animals were anesthetized with an intravenous injection of 20 mg kg sodium pentothal They were then intubated with a cuffed endotracheal tube and maintained on isoflurane gaseous anesthetic The femoral arte
25. g to change the battery the device will assume that the same patient is being monitored and the startup header shown at right will be displayed when turned on System On 12 06 56 Self Test Passed Welch Allyn PIC30 Operating Instructions Event Documentation Turning On Off the Chart Recorder 1 Press _Print_ Button to begin printing 2 Press Print Button again to stop printing Manual printout Each time the chart recorder button is pressed the following information will be printed Top Line PIC30 ECG Lead LEAD ECG Size A indicates AUTO sizing setting Heart Rate HR Sync on if activated Date Time Bottom Line Lead fault status frequency response pacer status if on and option is installed notch filter status N when the notch is on any error messages Normal Printout PIC30 Lead 1cm mV A HR 265 2 01 99 12 13 23 FREQ Monitor 0 5 to 40Hz Pacer On optional ECG Lead Fault PIC30 Lead II 1cm mV A HR 2 01 99 12 13 23 ECG LD FAULT FREQ Monitor 0 5 to 40Hz Welch Allyn PIC30 Operating Instructions 8 3 Event Documentation Automatic Printing The following printouts will be generated automatically if the Defib Pacer ECG Events or Alarm options are On in the Supervisor Setup Printer menu Each time an automatic printout is generated the following information will be printed Top line R for Real Time or P for Playback if pri
26. graph displayed on the monitor The unit will indicate disarm activate with change in pitch 10 seconds prior to disarm CAUTION If a new energy level is selected after the charge button is pushed and while the defibrillator is charging defibrillator will automatically charge to the new energy selection The CHARGE button need not be pressed again to select the new energy level CAUTION Any medical electronic device that is not labeled defibrillation protected must be disconnected from the patient Otherwise damage or patient injury may occur CAUTION Some erythema of the skin and or minor burns may occur during defibrillation Use proper defibrillation techniques as outlined in this operating instruction manual to minimize erythema burns Welch Allyn PIC30 Operating Instructions Warnings Cautions and Notices CAUTION Decision to shock must be made by qualified medical personnel trained in CPR and advanced cardiac life support PACER CAUTIONS OPTIONAL FEATURE CAUTION Defibrillation will take priority over external pacing Should the defibrillator be charged during the administration of external pacing the pacer will automatically be turned off and the defibrillator will charge to the selected energy CAUTION Transcutaneous pacing should not be used to treat V FIB ventricular fibrillation In cases of V FIB immediate defibrillation is advised CAUTION Transcutaneous pacing may cause discomfort ranging from mild t
27. l x2 S ME ea NEN EN D Lead Control and Display Pressing the button selects the ECG input Pressing up or down lead arrows will change the lead selection If the 3 lead cable is configured in the patient cable menu leads I II III are available 3 LEAD oo Lead I selected si ft 2 Lead II selected aaen 27 Lead III selected If the 5 lead cable is configured in the patient cable menu leads aVL aVF aVR and V leads are available in addition to leads I II III AUTO SLED AVR 2 Lead AVR selected 50 Avr 2 Lead AVF selected si AVL 2 Lead AVL selected v 2 Lead V selected If a paddle set PDL or hands free adapter PAD is connected either PDL or PAD lead option will be available in addition to 3 lead or 5 lead lead patient cable options s PDL 2 Lead paddles selected paddle set attached AUTO 3 LEAD PAD 2 Lead pads selected hands free adapter attached Hold Control Pressing and holding the Leld button will hold the trace s in the trace window When the Feld button is released the traces will resume chart recorder is not affected by the hold button Welch Allyn PIC30 Operating Instructions 2 5 Control Panel and Display Understanding the Quick Access Buttons and Features Quick access Quick access buttons window QUICK ACCESS BUTTONS E VOL
28. light should illuminate 12 Press the CHARGE button on the front panel Apply the paddles to the test contacts on the paddle tray or Welch Allyn Quick Charger Verify that the energy graph highlights as it charges up to 200J A periodic tone will sound while the defibrillator is charging At the completion of the charge cycle the tone will be constant and the energy graph will fill up to and include 200J 13 Ensuring that the paddles are properly applied to the test contacts press both the sternum and apex paddle discharge buttons The defibrillator should not discharge 14 Press the DISARM button on the front panel Pacer Test Optional steps 15 21 15 Remove the paddles from the PIC30 and connect the hands free adapter to the defibrillator Connect the 3LD Simulator P N 980139 to the patient end of the hands free adapter 11 6 Welch Allyn PIC30 Operating Instructions The defibrillator should discharge internally and the charge done tone and graph will disappear Connect Paddles message should appear in the defibrillation window when the paddles have been removed The Connect Paddles message should disappear when the hands free adapter has been installed Maintenance and Service 16 Press LEAD select button until PAD is selected The lead fault message should disappear 17 Press PACER button The Pace indicator should illuminate red and Pacer Fault Set Lead
29. nics rer Sd RT AES E De T HE Rul da dae ia dura 1 2 Inspection Upon Delivery 0 0 0 y e 1 3 General Descriplior vitesse neha gin Finke te pe pee qe aes 14 Safety Dedtures oie en ace on es utn RR eus bi uc eunti e oe 14 Equipment EE 1 5 Loading Recording aper 1 7 Summary of Operations a oh id wreath RR Deets 1 8 Welch Allyn PIC30 Operating Instruction 1 1 General Information 1 2 Accessories INCLUDED Part No 001790 001647 001725 002051 800576 001741 991022 971106 001853 OPTIONAL Part No 971107 971125 570310 001517 001516 001537 980139 001795 001796 001794 971108 971032 971031 001788 001781 001720 002052 971029 001638 971104 Welch Allyn PIC30 Operating Instructions Description 3 lead patient cable AHA Super Pac ECG electrodes Defibrillator gel 1 tube Power cord country dependent ECG chart paper Operating manual Standard paddle set Defibrillation pads adult Description Pacing and hands free adapter Internal paddle adapter Internal paddle cable Internal paddle electrode adult set Internal paddle electrode pediatric set Pediatric paddle adapters set 3LD Simulator 5 lead AHA patient cables 5 lead IEC patient cables 3 lead IEC patient cables Deluxe paddle set Field upgrade advisory option Field upgrade pacer option Multipurpose electrodes adult Multipurpose electrodes pediatric Bitrode limb electrodes KLEAN TRACE conductiv
30. of necessary maintenance and for scheduling periodic requirements such as calibration and certification Additionally the log can be used to track the age of accessories such as batteries which require periodic testing and replacement In accordance with the recommendations of the Defibrillator Working Group of the Food and Drug Administration Welch Allyn has provided an operator s shift check list which can be copied for use as needed see page 11 8 Visual Inspection 1 Inspect the PIC30 s Performance Calibration Log located on the bottom of the unit to insure that a PM Calibration has been performed within one year 2 Visually inspect the AC power cord ECG patient cable hands free and or paddles adapter for signs of wear or damage Replace if damaged 3 Locate and inspect the batteries monitoring electrodes multipurpose electrodes and paddle gel and ensure they are within the expiration date stamped on the package 4 Verify that a charged battery has been fully inserted into the battery compartment of the PIC30 5 Inspect the PIC30 to insure it is clean that no liquid has been spilled on the device and that it has not been damaged 6 Inspect the chart recorder to insure there is an adequate amount of chart paper 7 Perform the functional tests as described on the following pages 11 2 Welch Allyn PIC30 Operating Instructions Maintenance and Service TESTING THE PATIENT CABLE If the patient cable appear
31. of the display Press up arrow to increase and down arrow to decrease the energy setting Note The default energy level upon power start up can be changed to a lower or higher setting See page 3 11 ENERGY RANGE BAR Welch Allyn PIC30 Operating Instructions Selected Energy 200 CONNECT PADDLES The selected energy will be highlighted by a surrounding box and displayed in the defibrillator display window To increase the selected energy press the up arrow To decrease the selected energy press the down arrow 2 9 Control Panel and Display Charge Control and Display Charge The button initiates the defibrillator charge cycle When the charge button is pressed a periodic audible tone will sound the energy range bar graph will highlight the relative charge state until it reaches the selected energy When the defibrillator is fully charged the periodic tone will change to a continuous tone and the highlighted energy range bar graph will include the selected energy Note If the energy selection is changed during the charge sequence the unit will automatically charge to the new energy level and the display will be updated accordingly Selected Energy 200 Selected Energy Selected Energy Selected Energy 200 200 200 Charging Fully Charged Disarm Control Pressin
32. on each shock In practice actual clinical units were used so the energy steps were limited to those selectable on the devices tested The ED50 peak current and energy was then estimated for each animal by logistic regression analysis This study simulated a higher impedance patient by having a 32 ohm resistor placed in series with each subject Results The study consisted of 98 total fibrillation defibrillation episodes The mean ED50 and ID 50 estimates for peak current and energy for each animal to one decimal place are shown below The significance of difference p value was calculated by the Wald test in each case and are shown below Also shown are the mean total durations measured for each device Summary Table ED50 amp ID50 Mean Welch Allyn PIC 2kV Biphasic Biphasic Waveform ID50 Peak Current Amps Significance of difference p value ED50 Delivered Energy Joules Significane of difference p value Significane of difference p value Conclusion The MRL Orbital Biphasic waveform was as effective as the 2KV Biphasic waveform in this model of a higher impedance patient When these devices are compared on the basis of peak current the MRL Orbital Biphasic required less peak current than the 2KV Biphasic waveform RATIONALE FOR ANIMAL STUDIES Electrical waveforms for transthoracic ventricular defibrillation have been well studied for nearly 50 years These studies led to the development of monop
33. on the chart recorder with 6 seconds of ECC Bright x Pressing the bright button brightens the display There are 5 brightness settings The current brightness setting is displayed on the menu Each press of the button increases the brightness of the display once the highest brightness setting 5 is reached the next press of the button returns the brightness setting to the lowest setting 1 Welch Allyn PIC30 Operating Instructions 3 5 Program Menu Setup Setup Menu ECG Configuration Menus Alarm Setup Setup Supr EcgConf Grid Date Time EcgConf Pt Cable Filter Frequency Patient Menu Filter Men Cable Menu Setup Menu The Setup Menu appears when the setup control button is pressed ECG Configuration Menu The ECG Configuration menu allows the operator to set frequency response line filter and select patient cable type Frequency Menu Frequency Response Freq me In the Frequency Menu the user can choose between four SE frequencies Limited Monitor Filtered Diagnostic and Diagnostic The currently selected frequency will be highlighted with a bold Monitor A outlined box Press Limited Monitor Filt Diag or Diagnostic to Filt Diag choose a different frequency Pressing Exit will return you to the Display Configuration Menu The frequency response selection Diagnostic will set the display and the chart recorder response Limited response i
34. or jewelry Severe burns may result from improper placement of defibrillator paddles against the body surface WARNING Hazardous voltage To reduce the risk of electrical shock DO NOT attempt to remove the cover of the PIC30 under any circumstances Refer servicing to a qualified technician WARNING If safety procedures are not performed increased risk to patient operator and device can occur WARNING Shock hazard Use of accessories other than those specified in these operating instructions or additional equipment attached to the patient may adversely affect safe levels of patient leakage currents Welch Allyn PIC30 Operating Instructions i Warnings Cautions and Notices WARNING Defibrillator paddles should be kept clean and dry when not in use When preparing electrodes and during defibrillation procedures extreme care should be exercised to prevent gel or any conductive material from forming a pathway between the operator and metal electrodes of the paddles Do not allow gel or any other conductive material to form an electrical bridge between the defibrillator electrodes or to the monitoring electrodes Electrical arcing and or patient burns could occur during defibrillation Arcing and patient burns could prevent sufficient defibrillation energy from being delivered to the patient GENERAL CAUTIONS ACCESSORIES Use only authorized accessories listed on page 1 2 of this manual Use of unauthorized accessories may ca
35. patient s ECG on the display If using paddles apply electrode gel to ELECTRODE PLACEMENT the center of one paddle electrode SEES Lightly press the paddle electrodes see page 5 3 together and spread the gel evenly over for 5 lead both paddle surfaces Make sure the gel PR covers the entire paddle surface Do not allow any gel to touch the paddle handle or the operator s hands synchronizer The light next to the Sync button will illuminate and an S marker will appear over the portion of the ECG that the defibrillator will trigger on The Sync light will flash off with each Sync marker Note If the marker pulse does not appear over the R wave turn lead select to another position 1 II III or adjust ECG size If the Sync marker is not obtained the defibrillator will not discharge Do not switch the lead from PADS if monitoring with hands free defibrillation pads Press button on the front panel up CARDIOVERSION PADDLE PLACEMENT or down to select the desired energy level Charge the defibrillator by pressing the button on the defibrillator panel or the button on the deluxe apex paddle An audible tone will sound periodically indicating that the unit is charging The energy range bar on the right side of the display will highlight the relative charge state until it reaches the selected energy When the unit is fully charged the periodic Apex tone will change to a continuous tone and the highli
36. to I II III should be displayed in the Pacer window 18 Connect ECG patient cable to the PIC30 and to the 3LD Simulator P N 980139 Press the LEAD button to select lead I 19 Press pacer Start Stop button on the pacer controls An ECG trace should appear in the ECG window In the Pacer window Pacer Stop should appear with the default pacing parameter ie rate and output setting The pacer window will indicate pacing The pacer indicator light will illuminate green and flash to verify output 20 While the pacer is pacing disconnect the patient cable from the PIC30 21 Press PACER button The pacer window should indicate Pacer Fault ECG Lead Fault also Lead Fault should appear in the ECG window The pacer indicator lights red indicating the fault condition and that the pacing output has been suspended Pacer indicator light should turn off and pace window should be blank 22 Press the Print button until the header and footer are printed out completely Verify that the date and time are properly set 23 Press the NEXT button on the treatment summary menu Then press Recorder and Log The Log menu should appear next to the quick access buttons 24 Press CLEAR LOG button to erase the log Clearing event storage will be printed to confirm clear 25 Turn the PIC30 off Welch Allyn PIC30 Operating Instructions 11 7 MANUAL nEFIBRILLATORS OPERATORS
37. 00J Applicable Performance Standards AAMI EC13 AAMI DF2 AAMI EG EN 60601 2 27 EN 60601 1 2 EN 60601 1 4 UL 544 CSA 22 2 No 125 ISTA 1A Monitor Display Inp tz 2er Vu aan Re Rs 3 lead or 5 lead patient cable paddles or multipurpose hands free adapter SIZE EE wwe pue dad eas 6 4 inch 16 2 cm diagonal non fade ji eee Color TFT or Monochrome LCD Resolution sesso re basia diiri 640 x 480 pixels Sweep Speedi coe Cute tau ERES 25 mm sec Lead Selections Paddles Pads I II HI AVR AVL AVF V Frequency Response iiiv casses User selectable 2 to 20 Hz Limited mode 0 5 to 40 Hz Monitor mode 0 05 to 150 Hz Diagnostic mode automatically sets chart recorder response Common Mode Rejection Complies with AAMI EC13 1992 section 3 2 9 10 Tall T Wave Rejection Meets AAMI EC13 1992 section 3 1 2 1c for 1 2 mV T wave 1 0 mV with diagnostic response and 1mV QRS Diagnostic Signals Applied to Patient Connections Leads off active noise suppression sensing circuit is lt 0 luA DC The impedance detector signal frequency is 45 4kHz at 78uA RMS 117mV RMS into an impedance of 1 5k pseudo sinewave Heart Rate Meter 20 to 300 BPM Complies with AAMI EC 13 1992 sections 3 2 6 amp 3 27 Heart Rate Alarms xi isecec cecrkan User selectable Low range 20 120 BPM High range 60 300 BPM or automatic based on hea
38. 400 Hz alternating tone with a PW of 200 msec a PRI of 400 msec and a repetition interval of 3 seconds Heart Rate Alarm causes the displayed heart rate to flash at 2 Hz This 1 cm display is located at the top of the display and is 4 high and 28 to 840 0 7 TO 2 cm wide depending on number of digits in the heart rate Color is black on white Audible 3 pulse 500 Hz triplet tone with a PW of 300 msec a PRI of 600 msec When the HR alarm is set or the pacer is on the lead fault tone repeats at a repetition interval of 6 seconds Lead Fault condition causes a LEAD FAULT message to be displayed on the trace along with a dashed line the width of the trace The text is 18 0 46 cm high and is the color of the display text The dashed line is 5 12 cm long the width of the display The signal is not modulated 90 seconds Global alarm disable via 2 step Quick Access icon controls or individual High Low limit disable via configuration menus High resolution thermal array 800dpi 31 5 dpmm Horizontal 244 dpi 9 6 dpmm Vertical Time date ECG lead ECG gain heart rate defibrillation and pacing parameters and event type 50 mm 25 mm sec Specifications Delage Wang Event Log Event Log Capacity Recorder Modes Grid Rn Power Mains Line Voltage Mains Line Frequency AC Power Consumption Battery Ke EE Low Battery Indicator
39. Button Unlocks the adapter connector from the defibrillator to allow removal Note When sliding the multipurpose hands free adapter on make sure the release button clicks into place and returns to its up position TURNING THE UNIT ON AND OFF Name Press the switch on the PIC30 The unit performs a SE self test and prints out the strip To power off the unit press PC the switch on the PIC30 SN wox SW Rev xx Test Strip 1 6 Welch Allyn PIC30 Operating Instructions General Information Loading Recording Paper The check recorder icon will appear in the message window of the display when Free end of paper on top Roll in chart recorder with swing door closed Note The low paper indicator is signified by a black or red strip at the top of the the chart paper is empty or the chart recorder door is not closed properly Swing door Release lever When inserting the paper roll the free end should be over the top of the roll chart recorder paper When the indicator appears approximately 8 ft 2 4 m of paper is left on the roll Note USE only Welch Allyn approved paper kA recorder Open the door by pushing on the release lever located on the side of the chart 2 Remove the empty spool core Place the new roll of ECG paper with the free end of the paper on top of the roll Insert the new spool until it snaps onto the spool retaining arms The spool should be pos
40. Chapter External Pacing optional External Pacer Operation Procedures optional 7 2 Welch Allyn PIC30 Operating Instructions 7 1 External Pacing MULTIPURPOSE DEFIB ELECTRODE PLACEMENT White RA or Red R Anterior Posterior l White RA Black LA H or Red R or Yellow L Black LA or Yellow L Y Red LL or Green F Red LL or Green F A External Pacer Operation Procedures optional 236536534 7 2 10 11 Press switch to turn on pacer Apply ECG monitoring electrodes as illustrated above Connect PIC30 ECG patient cable to the patient and the PIC30 Connect the multipurpose hands free adapter to the PIC30 Make sure the connector locks into place and that the release button returns to its up position Apply multipurpose defibrillation pacing electrodes to patient as illustrated on the electrode package Use PIC30 Adult Multipurpose electrodes P N 001853 for adult patients and Pediatric Multipurpose Electrodes 001781 for pediatric patients lt 10kg Connect multipurpose defibrillation pacing electrodes to the multipurpose hands free adapter Press Lead and select I II or III to provide the largest amplitude QRS complex Press and adjust size to insure proper sensing of the patient s heart rate Confirm that the displayed heart rate coincides with the patient s heart rate
41. ECG in sections 4 and 5 Welch Allyn PIC30 Operating Instructions 10 3 Troubleshooting Recognizing and Reducing ECG Artifacts Rapid large and erratic defections A broken wire in the patient lead or a poorly applied sensor may cause rapid large and erratic trace deflections Irregular frequency or amplitude Patient movement and muscle tremor may result in abnormal traces Attempt to gain the patient s cooperation in staying very relaxed and still Sometimes somatic tremor is unavoidable but its effects may be minimized by having the patient place his her hands under the buttocks Baseline wander Poorly affixed sensors may cause the baseline to wander Normally the baseline will stabilize within a few seconds If the baseline shifts up and down it may be due to the patient s breathing or to loose or corroded sensors Wide baseline Electrical interference may produce a wide baseline Its amplitude depends on the strength of the current source and the lead being recorded In any one lead the amplitude of the interfering signal is uniform 10 4 Welch Allyn PIC30 Operating Instructions Troubleshooting To reduce electrical interference Keep the power cord away from the patient and patient cable Connect the unit to a properly grounded wall outlet Arrange the patient cable leads together closely following the body contour Ensure X ray equipment in adjacent rooms is not operating O
42. Energy i LN Charge Sync Pacer b _ Mode Rates fem Gay N 200 ENS PAcER O sao 55 amp l Select 2 Quot mii oup J Com f e GER 5 d X HN DEFIBRILLATOR VVVVVV V CEA C3 ER BS CR ce J Start Stop Pacer Waveform Output window window Note The external pacer is optional To add pacing capability to your PIC30 contact your Welch Allyn customer service representative External pacing functions on the PIC30 are viewed on and controlled by the areas indicated above Note The following operations of the external pacer depict normal factory default settings Later in this chapter we will discuss supervisor configurations of the external pacer Initial pacer display upon pacer power on When the PIC30 is powered on the external pacer default oe position is off To turn on the external pacer press the pacer 30 mA DEMAND button When the pacer turns on the default parameters will be displayed in the pacing window Factory Pacer Defaults Pacer Display Messages Pacer Stop Pacer Stop indicates that pacer is on and paused will not EE deliver pacing pulses to patient 60 BPM indicates pacing 30 mA nnm DEMAND rate set at 60 beats per minute 30 mA indicates the pacer output in milliamperes Demand indicates that the pacer is set in demand mode Note Pacer Fault messages may appear if the pacer detects a fault condition Pads
43. G through the paddles may result in inaccurate heart rate display due to artifact CAUTION In the SYNC mode the defibrillator will not discharge without a command R Wave signal indicated by a SYNC marker flashing SYNC indicator and an audible beep if the R wave beeper is enabled CAUTION Do not use the defibrillator if excessive condensation is visible on the device CAUTION Use only Welch Allyn approved disposable defibrillation and pacing pads and cables Ineffective pacing or defibrillation may result CAUTION Improper defibrillation technique can cause skin burns To limit possible skin burns use only approved defibrillation gel on paddles insure that the gel covers the entire paddle surface and press firmly against patient s bare chest no electrodes or foreign objects underneath the paddles CAUTION Disposable defibrillation electrodes must be used in accordance with the manufacturer s instructions Do not use expired dry electrodes or reuse disposable electrodes as improper patient contact may result in patient burns and inability of the device to function properly and or ineffective defibrillation CAUTION The device contains an automatic disarm of the stored energy If the operator has not delivered the energy to a patient or test load an internal timer will disarm the stored energy 1 minute after the charge ready signal occurs The charge ready signal is indicated by a continuous audible tone and the energy availability
44. Operating Instructions Maintenance and Service POWER SYSTEM Functional Tests Function Response Q Verify that the AC power cord is firmly connected to the paddle tray or the Welch Allyn Quick Charger with the AC cord holder and that the power cord is connected to the appropriate outlet Green AC PWR light on the PIC30 paddle tray or on the Welch Allyn Quick Charger is illuminated 2 Insert a battery in the unit and check for battery charging indicator The Batt Charger light will illuminate if a battery is inserted in the PIC30 The light illuminates steadily if battery is charging It should begin to blink when battery is charged 3 Press the system POWER switch on The PIC30 will perform a number of self tests and print out the results pass or fail on the chart recorder Verify that the AUX power icon is displayed in the Message window 4 With no patient cable attached to the PIC30 press the LEAD Selector button to select Lead I II or III Verify that a lead fault message is displayed in the waveform window 5 Press the LEAD Selector button to select PDL paddles Verify that a lead fault message is displayed in the waveform window 6 Apply the paddles to the test contacts on the paddle tray or Welch Allyn Quick Charger Verify that the lead fault message disappears from the waveform window and that the trace is in the center of the waveform window
45. Otherwise serious injury or death could result WARNING NEVER position defibrillator paddles very close to or over ECG electrodes Severe burns may result from improper contact of defibrillator paddles Before using defibrillator consult these operating instructions for proper procedures Includes electrically isolated patient inputs This conforms to IEC and AAMI ANSI requirements This symbol next to the patient cable connector indicates this equipment is classified as defibrillation protected Type CF equipment The patient cable and input circuits are designed to prevent damage if the unit is connected to a patient during defibrillation Welch Allyn PIC30 Operating Instructions General Information Equipment Setup STANDARD ADULT PADDLES Sternum Paddle Discharge button Sternum Paddle Discharge button Energy selection button DELUXE ADULT PADDLES optional Note The battery that is shipped with your new PIC30 is not charged To charge the battery and prepare the PIC30 for normal use follow the instructions below INSERTING THE BATTERY INTO THE PIC30 To insert the battery locate the battery slot on the right side of the PIC30 and slide the battery in connectors first Press the battery firmly back into the slot to assure proper connection of all 4 contact points on the battery CHARGING A BATTERY If paddle holder charger is installed plug the unit s AC power cord into a wall outlet and insert batte
46. Upgrade Password Menu The Upgrade Menu allows the addition of options to the PIC30 in the field Contact your Welch Allyn customer service representative for instructions on upgrading the PIC30 Entering the upgrade password The ADV Password menu gives the operator the option of moving the cursor forward or Backward or clearing canceling or saving the entry 1 Enter a new character by pressing once on the group of characters containing the character of your choice B In this case we want to change the 1 to a 0 Note The upgrade menu window is replaced by a numeric window The password is displayed just above the numeric window with an active cursor in the first space Upgrade Menu Adv Numeric window 1 2 3 4 1 2 3 4 5 6 7 8 9 0 Space C B 1 2 3 4 9 0 ee o 2 3 4 1 2 3 4 5 6 7 8 9 0 Space 2 Press on the actual character C Your selection will be entered and the cursor will move to the next character in the identifier Continue this procedure to complete the password 3 Press the SAVE button in the ADV Password menu to save the selection and return to the Upgrade menu A symbol should now appear after ADV indicating that the option was successfully installed 3 16 Welch Allyn PIC30 Operating Instructions Program Menu Setup PIC Lite Operating Instructions 3 17 Chapter Patient Preparation Preparing Patients for ECGS as rex y Rer HC OP OP IR Oe
47. apex posterior placement of pads results in a modified Lead II ECG trace Welch Allyn PIC30 Operating Instructions Chapter Defibrillation Defibrillation with External Paddles 1 22 oe eee 6 2 Defibrillation with Pediatric Adapter 0 c cece ee eee ee 6 3 Defibrillation with Multipurpose Hands Free Pads optional 6 4 Performing Synchronized Cardioversion 05 eee ee 6 5 Welch Allyn PIC30 Operating Instructions 6 1 Defibrillation Defibrillation with External Paddles 1 Press switch to On 2 Apply electrode gel to the center of one paddle electrode Lightly press the paddle electrodes together and spread the gel evenly over both paddle surfaces Make sure gel covers the entire paddle surface Do not allow any gel to touch the paddle handle or the operator s hands 3 Press button on the front panel up or down to select the desired energy level energy selection is also available on the deluxe paddle set 4 Press the button on the defibrillator panel to charge the defibrillator charge selection is also available on the deluxe paddle set An audible periodic tone will sound indicating that the unit is charging The energy range bar graph on the right side of the display will highlight the relative charge state until it reaches the selected energy When the unit is fully charged the periodic tone will change to a continuous tone and the highlighted energy range bar graph
48. ately the capacity of your battery throughout the battery s life Thus when the icon is displayed at 50 full you can roughly determine based on your most recent maintenance test how much actual capacity is remaining in the battery CHARGER AND BATTERY CARE To achieve optimum performance from your PIC30 battery packs Charge battery packs in a moderately cool environment 5 to 30 C 41 to 86 F All NiCad batteries are adversely affected by charging at extreme temperatures and will exhibit a significant decline in useful operating time if charged at temperatures above 35 C 95 F or below 0 C 32 F Perform periodic conditioning cycles on battery packs Welch Allyn PIC30 Operating Instructions 9 5 Chapter Troubleshooting Troubleshooting Basic Unit Problems eme NN erre men 10 2 Troubleshooting Trace Problems 4222 bebe eae eh re 10 3 Recognizing and Reducing ECG Artifacts 00000 10 4 Welch Allyn PIC30 Operating Instructions 10 1 Troubleshooting Troubleshooting Basic Unit Problems PROBLEM PROBABLE CAUSE CORRECTIVE ACTION Unit will not turn on Display quality is poor Defibrillator won t charge CONNECT PADDLES message is displayed Defibrillator energy select switch does not respond when pressed AC power indicator does not illuminate Battery icon is displayed when AC line power cord is connected Charge light does not illuminate
49. bury Drive Dublin Road Buffalo Grove IL 60089 Navan Co Meath USA Republic of Ireland Phone 847 520 0300 Phone 011 353 466 7775 Fax 847 520 0303 Fax 011 353 466 7128 declares that the CE marked product Product Name PIC30 Portable Intensive Care Base Units 972039 PIC30 BIPHASIC MONOCHROME DISPLAY 973039 PIC30 BIPHASIC COLOR DISPLAY Options 971029 Charger 971031 Pacing 971032 Advisory Device Type Defibrillator External Transcutaneous Pacemaker Multifunction Monitor complies with Council Directive 93 42 EEC Medical Device Directive of 14 June 1993 class IIb Annex II Standards General ISP 9001 EN 46001 Safety IEC 601 1 EN 60601 1 Class I Continuous operation Type BF with external paddles or Type CF with internal paddles IEC 601 1 4 EN 60601 1 4 IEC 601 2 4 EN 60601 2 4 IEC 601 2 25 EN 60601 2 25 EN 475 EMC EC 601 12 EN 60601 1 2 Huy Doan Date Site Quality Manager Welch Allyn PIC30 Operating Instructions Table of Contents Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Table of Contents Intended Use itecto hoe de qtto Inglesa irte dr outer i Warnings Cautions and Notices sesso saca srrerereaici ss ta asaca i Definitions of Symbols Used 0 2 0 0 0 ccc ee eee vii General Information cos sea ACA ae POKES COR 1 1 JACCeSSOPIES cose du BEER escuche Sed xcd LE dod ae ws ere 1 2 Inspection Upon Delivery creer Ree tee x eee 1 3 Gene
50. cially available Biphasic 2KV defibrillator capable of 360 J in a simulated higher impedance model Methods A canine model n 6 53 7 6 1 Ibs was used in a study that was approved by the Institutional Animal Care and Use Committee The animals were anesthetized with 20 mpk sodium pentothal i v and maintained as required through an intravenous catheter in the foreleg The femoral artery was cannulated and an intra arterial line was placed for continuous measurement of arterial blood pressure The chest was shaved and defibrillating patch electrodes were placed on the left and right chest walls Fibrillation was induced by delivering 60 Hz current to the chest electrodes The energy required to defibrillate was determined by a protocol that has been used in several other biphasic comparison studies An initial shock strength of 70 to 100 joules was used If successful VF was re induced after a 5 minute rest period and the shock strength was reduced by approximately 2076 for the next defibrillation attempt If the initial shock 12 10 Welch Allyn PIC30 Operating Instructions Specifications failed a rescue shock was delivered and after a rest period VF was again induced The energy was now increased about 20 for the next defibrillation attempt This procedure was continued until approximately 4 reversals in result were observed with each waveform Two ED50 estimation procedures were run in parallel with the device being used alternated
51. ck Access Configuration menu Defib Defib Defib Defib 5 mode rate energy charge disarm sync 7 select Pacer Pacer Start stop output Chart recorder print Activates and deactivates the chart recorder Mute Pressing the MUTE button once causes all audio alarms and tones to be muted for 90 seconds except defibrillator charge tones Pacer on off optional Turns on off pacer circuit Pacer indicator optional Automatically illuminates during pacing activity Pacer start stop optional Delivers pacing stimulus to the patient or pauses delivering pacing stimulus to the patient Pacer mode optional Changes pacing mode from DEMAND to Async Pacer output optional Selects pacing output current Pacer rate optional Selects pacing output rate 9 10 11 12 13 14 15 16 17 18 15 Sync indicator Quick access Initiates menu functions appearing adjacent to each button on the display when the PIC30 is on Configuration menu Allows documentation of ECG sample events and access to setup menu windows Defib energy select Select defibrillation energy levels Defib charge Initiates defibrillator charge to selected energy Defib disarm Disarms charged defibrillator internally Defib sync Activates the synchronization mode Sync indicator Light that indicates sync activation Size Selects ECG trace sizes Lead Selects ECG
52. d 8 For additional counter shocks repeat steps 4 through 7 9 To secure the instrument turn the power switch to Off Clean the patient cables and controls as outlined in chapter 11 10 If battery power was used recharge the battery by connecting the PIC30 to AC power or replace the used battery with a fully charged battery and check that there are sufficient supplies for the next use 6 4 Welch Allyn PIC30 Operating Instructions Defibrillation Performing Synchronized Cardioversion 1 2 3 4 N Press the button to engage the RA WARNING Elective cardioversion should only be performed while monitoring patient with patient cable and electrodes or hands free defibrillator pads Although the device will allow synchronized cardioversion in the PDL paddle lead selection it is not recommended that Sync be performed in the PDL lead Artifact can be generated from the paddle cables which could cause the defibrillator to discharge on the artifact Press switch to On Attach the electrodes to the patient Position the electrodes to allow immediate placement of the defibrillator paddles Attach an ECG electrode to each lead of the patient cable Connect the ECG patient cable plug to the ECG input connector Press the button to select lead II position if using the hands free defibrillator pads select PAD lead position If using 5 lead patient cable see page 3 7 to change 3 lead selection to 5 lead Observe the
53. d by magnetic resonance imaging MRI equipment The large magnetic fields generated by an MRI device can move ferromagnetic equipment with an extremely violent force which could cause serious personal injury or death to persons between the equipment and the MRI device LABELS Observe all CAUTION and WARNING labels on the equipment and accessories PATIENT OR OPERATOR PHYSICAL HARM Place the PIC30 System accessories and cables in a position where they cannot harm the patient should they fall Keep all cables away from the patient s neck and feet to prevent entanglement Welch Allyn PIC30 Operating Instructions Warnings Cautions and Notices PERFORMANCE The PIC30 may not meet performance specifications if stored transported or used outside the specified storage or operating environmental range limits EVENT LOG SUMMARY To prevent incorrect trending data from being printed clear the Log from the Log menu prior to use on a new patient MONITORING CAUTIONS CAUTION Use only PIC30 patient cables Other cables can produce excessive artifact causing an inability to interpret the ECG CAUTION Use only ECG electrodes that meet the AAMI standard for electrode performance AAMI EC 12 Use of electrodes not meeting this AAMI standard could cause the ECG trace recovery after defibrillation to be significantly delayed CAUTION The type of surface ECG electrodes and the technique used in applying the electrodes are major factors i
54. defibrillator WARNING Hazardous high voltage is present when the defibrillator is discharged during this test Observe safety precautions regarding the use of a defibrillator To test the defibrillator 1 Charge the defibrillator to 200 Joules 2 Place the defibrillator paddles in the Paddle Holder tray or apply the defibrillation paddles to the test contacts on the Welch Allyn Quick Charger Conditioner 3 Discharge the defibrillator into the paddle tray 4 The defibrillator test light at the back of the charger should flash indicating that the defibrillator has delivered 180 Joules or greater 5 Verify that the delivered energy displayed on the defibrillator screen is 200 10 Note Periodically test your defibrillator with a calibrated defibrillator tester to verify the accuracy of its energy output Inspecting for Damage WARNING Hazardous voltage To reduce the risk of electrical shock do not attempt to remove the cover under any circumstances Refer servicing to a qualified technician Before every use check the power cord power plug power connector and power input jack for signs of damage Contact an authorized service agent immediately if The equipment falls from a cart or is subject to some other extreme mechanical stress Liquid is spilled on the equipment The equipment is not functioning properly Any connector or cord shows signs of deterioration such as cracking 11 4 Welch Allyn PIC30
55. des 4 Bell symbols in the Heart Rate window indicate the status of the HR alarm A alarm off A alarm on A alarm upper limit set aa alarm lower limit set A automatic HR alarm set Lead Fault Display The ECG trace will be replaced with a dotted line and the words LEAD FAULT to indicate a lead fault condition Lead fault condition may have occurred due to improper connections on the patient cable lead wires and should be inspected for proper contact and connection Replace the electrodes if necessary In rare cases an excessive offset voltage on the ECG electrodes may cause a lead fault condition This condition could result in recovery time up to 20 seconds after defibrillation LEAD FAULT Welch Allyn PIC30 Operating Instructions Control Panel and Display Size H Lead H Size Control and Display Pressing the button selects ECG trace sizes from 0 125cm mv to 4cm mv and automatic trace sizing Pressing the up arrow will increase the ECG size Pressing the down arrow will decrease the ECG size The AUTO size setting will automatically select the proper gain to fit the ECG in the waveform window When the PIC30 is turned on the default setting is AUTO CAUTION Do not use the auto size setting for diagnosing asystole Set the size to 1cm mV to maintain a fixed ECG display gain example Auto size is set and 4cm mV was selected Manual size set at 2cm mV 3 LEAD
56. e a different lead configuration press the corresponding quick access button Pressing Exit will return you to the Display Configuration Menu If the patient cable inserted into the PIC30 does not match the patient cable configuration selected a lead fault alarm may sound Welch Allyn PIC30 Operating Instructions 3 7 Program Menu Setup Setup Menu Grid Time Date and Supervisor Code Menus PIC30 Alarm Setup Log Sample Ew Supr EcgConf Grid Supervisor Password Supervisor Menu Peint and In the Print Grid menu the user can choose to print or not to print grid on chart paper by turning the print grid on or off In the Print Grid ON mode the chart recorder will print a grid on plain white o paper The current selection will be highlighted with a bold outlined box To choose a different option press the corresponding button Pressing Exit will return you to the Setup Menu Grid Menu Date Menu Time Menu On Set Date Month To set the month press the corresponding button A bold outlined box will appear around the month window Press the up or down Day arrow to select the month Follow the same procedure to set the day and year When finished press save 99 3 8 Welch Allyn PIC30 Operating Instructions Program Menu Setup Hour 12 Minute 0 Reset to 0 Set Time To set the hour press the corresponding button A bold outlined box will app
57. e alarm icon in the heart rate window will display the appropriate status 3 Set the lower limit The lower limit can be either set or disabled To set the lower limit press the lower limit button A bold line will appear around the box Press the up or down arrow to increase or decrease the lower limit value You can disable the lower limit by pressing the lower limit button again to display Disabled below the words Lower Limit The alarm icon in the heart rate window will display the appropriate status 4 Exit Press Exit to leave menu Welch Allyn PIC30 Operating Instructions 3 3 Program Menu Setup Turning on and setting the Auto HR alarm 1 Set the HR alarm to auto by pressing the Off On Auto button until Auto is selected When the HR alarm is set to auto the auto alarm icon amp will appear in the HR window and the global alarms will be turned On Note The upper and lower limits will be undetermined if a valid ECG is not present 2 Exit Press Exit to leave the HR alarm menu 3 To set the automatic HR alarm limits press the quick access Auto button next to the e icon The patient s heart rate at the moment the button was pressed will be displayed above the heart 2 The HR alarm monitor automatically sets the upper and lower heart rate limits at 20 of that heart rate set point or 10 beats whichever is greater Each press of the Auto button will adjust the heart rate set point and reset
58. e lead fault has been corrected the lead fault message will be removed from the display and the pacing indicator next to the pacer On Off button will change from red to orange To begin pacing again press the button Note Should a lead fault occur after you have achieved capture the pacer will automatically revert to the stop mode The rate and output current settings will remain at the last settings used before the lead fault occurred To resume pacing correct the lead fault and press the button 7 4 Welch Allyn PIC30 Operating Instructions Chapter Event Documentation Chart Recorder Startup Printout 004 2s lt 0s e aee e d 8 2 Turning On Off the Chart Recorder i iae ERE y o 8 3 Automatic Printing oses eek DELE Renee SES 8 4 Event Log SUMMAT isi ere ih iot he Re P eh RR Ree prend 8 5 Welch Allyn PIC30 Operating Instructions 8 1 Event Documentation 8 2 Chart Recorder Startup Printout Chart recorder System On Header Each time the PIC30 is powered on the unit will perform a self test and the results of the test will be printed on the header The date and time the system was turned on the unit serial number and software revision level will be printed on the header if the device has been turned off for more than 2 minutes NEW PATIENT Name SYSTEM ON 01 06 97 12 05 44 Self Test Passed WING azis jenjoe If the device was switched off briefly for less than 2 minutes e
59. e spray Paddle tray charger SmartPak Plus battery Quick Charger General Information Inspection Upon Delivery Your new PIC30 was carefully inspected before shipment Inspect your unit upon delivery for any damage which may have occurred in transit If you notice any damage please contact your shipping agent If items are missing contact your local representative or call Welch Allyn Inc Technical Service Department at 800 462 0777 or 847 520 0300 To determine the initial installation condition of the PIC30 after shipment follow the simple steps below 1 Open and carefully unpack each carton 2 Examine the instrument and accessories for signs of damage 3 Check the packing list to determine that all accessories have been received Save all packing materials invoicing and any other paperwork in case discrepancies occur Connect defibrillator paddles or optional hands free adapter by sliding connector on here Power switch Insert battery on right side of PIC30 DETERMINE SOFTWARE SETUP In order to ensure that the device is running properly after shipping and the proper features are installed follow the instructions below 1 Connect defibrillator paddles or the multipurpose hands free adapter 2 Plug the AC power cord into the PIC30 and into a power outlet 3 Insert a PIC30 battery into the battery slot and charge battery 4 Press the PIC30 power switch to ON 5 The PIC30 will perform a series o
60. ead select to leads I II or III Check pads and ECG electrodes Troubleshooting Troubleshooting Trace Problems PROBLEM PROBABLE CAUSE CORRECTIVE ACTION LEAD FAULT and dashed lines Patient cable not properly connected Make sure patient cable is properly displayed to unit connected LEAD FAULT and dashed lines Lead wire s disconnected from Check electrodes and leads displayed for one or more leads All patient others are OK Replace the patient cable Damaged lead wire s Baseline is drifting in waveform for one or more leads Poor patient preparation Use of dissimilar sensors or sensors not recommended for use with PIC30 Poor sensor contact with skin Refer to instructions for patient prep in section 4 Only use electrodes recommended for use with the PIC30 Refer to instructions on page 4 3 Trace is noisy The waveform is not a single clean line AC interference from lighting cables or equipment near patient Improper line filter setting Re position ECG cables Check line filter setting in the SETUP ECG CONFIG menu Occasional noise or artifact in the waveform for one or more leads Patient movement Muscle tremor noise Improperly applied sensors Electrical interference Poor sensor contact with skin Ineffective baseline filter setting Refer to instructions for monitoring
61. ear around the hour window Press the up or down arrow to select the hour Follow the same procedure to set the minute When finished press Save Entering the Supervisor Menus The default access code for entering the supervisor menus is 1 2 3 4 This code may be changed by the supervisor see 3 14 Pressing each button will increment the corresponding digit To reset the code press Reset to 0 When all four digits are entered press Enter to enter the supervisor menu The Lock icon on the supervisor menu title block will open in if the correct code has been entered If the code is lost contact your Welch Allyn authorized service representative Note Be sure to write down the new supervisor code in a safe place Welch Allyn PIC30 Operating Instructions 3 9 Program Menu Setup 3 10 Overview of Supervisor Menus Supr EcgConf Grid Date Time Back Supervisor Password Optional Supervisor Defib Pacer SE peg Alarms Exit Alarms Menu Supr Defib Ext Eng Int Eng Mode Alarm Back Ext Energy Int Energy CV Mode Alarm Menu Menu Menu Menu Supr Pacer Pace Mode Rate Menu Men Supr Setup Code Date Printer Line Freq Upgrade Language Line Freq Date Format Upgrade Language Printer Lead Menu Menu Password Menu Code Menu Menu Menu
62. ery pack in your regular trash The incineration land filling or mixing of NiCad batteries with municipal waste is PROHIBITED BY LAW in most areas Return this battery pack to a government approved battery recycler Contact your local waste management officials for more information NOTICE U S Federal law restricts this device to use by or on the order of a physician NOTICE If the battery pack is removed for any reason labeling of the PIC30 is required indicating out of service for battery operation Welch Allyn PIC30 Operating Instructions Definitions of Symbols Used Definitions of Symbols Used SAFETY SYMBOLS Graphical symbols letter symbols and signs listed below may be found on the PIC30 and accessories Please note the use of these symbols for safe and proper use of the equipment Alternating current Attention consult accompanying documents L gt Auxiliary power operation T X Caution high voltage Dangerous voltage we Defibrillator protected type BF patient connection Pj Defibrillator protected type CF patient connection Earth ground n CERTIFICATION SYMBOLS OWOo Negative input terminal Positive input terminal Power off Power on Recycle battery Protective earth ground Defibrillator discharge button Release C This symbol on the device indicates that the device meets the o requirements of Council Directive 93 42 EEC MDD Cla
63. ery pak should be inserted in the PIC30 at all times This will allow for the battery to be charged whenever the AC line power cord is plugged in Note It is recommended that a fully charged battery be inserted in the PIC30 when operating on AC line power NOTICE If the battery pack is removed for any reason labeling of the PIC30 is required indicating out of service for battery operation Welch Allyn SmartPak 12 volt battery provides power to the PIC30 Multiple paired contacts Four contacts ensure SMARTPAK PLUS STATUS NDICATOR i d CAUTION swift error free 1 Important saftey considerations FLASH atten battery Y Charge prior to use i B S E Y Charge only in the MRL battery charger m A insertion and Y Always have back up power available T wi ga Y Refer to manual for battery maintainence T backup AX Y Do not directly connect the negative and positive terminals E V T Y Do not incinerate 4 D R reliability 2 To prevent deterioration or damage to the battery y Y Do not drop or subject to strong physical shock YEDo not use to power equipment other than MRL products T 2 WelchAllyn MES L WELCH ALLYN SUPERPAC BATTERY The Welch Allyn SuperPac battery is a nickel metal hydride NiMH battery NIMH batteries are less suseptible to the memory effect associated with NiCd batteries It weighs only a few ounces more than the SmartPak yet provides twice the capacity T
64. es concurrently Indicators uina n ese pomeranian Battery Charging Ready Reconditioning Defibrillation Test Indicator Power On Reconditiotier ac SEN ree eee ds Simple one button operation Reconditioning Load 220 mA 10 constant Recondition Cycle Time Dependent on battery capacity and state of charge typically lt 12 hours External Power Output Voltage 13 Volts 0 65 V 12 6 Welch Allyn PIC30 Operating Instructions Specifications Fuse Ratings 0 c cece eee General Chargers ugeet Eech Defibrillator Tester PADDLE HOLDER CHARGER Mains Line Voltage At ae eg Mains Line Frequency EE AC Power Consumption Dual Line Fuses 120 VAC 2 Amp SB Welch Allyn 500218 220 VAC 1 Amp SB Welch Allyn 500241 Operating Temperature 0 to 45 C Humidity 15 to 95 Size 11 5 x 7 25 x 4 4 inches 29 2 x 18 4 x 11 2 cm Built in 50 Ohm load 100 to 240 VAC 10 autoranging 50 to 60 Hz 5 18 W typical Maximum 190 W while charging defib Welch Allyn PIC30 Operating Instructions 12 7 Specifications Summary of Studies of Waveform Safety and Effectiveness INTRODUCTION Over 30 years ago Medical Research Laboratories MRL patented a unique monophasic truncated exponential waveform which utilized a low peak current impedance compensated defibrillation waveform The MRL monophasic waveform was developed as an alte
65. ess may take several minutes B Welch Allyn SmartPak contain NiCad batteries which tend to lose charge capacity if they are repeatedly charged after not being fully discharged or are charged at high temperatures In order to counteract these cumulative deteriorating effects it is recommended that you periodically exercise the SmartPak by deeply discharging it in the Reconditioning Slot Slot 3 before recharging See reconditioning schedule later in this chapter O1 Slot 3 on the Welch Allyn Battery Charger has dual charging and reconditioning capabilities To use slot 3 only to charge a battery pack follow the directions above Conditioning Battery Packs with the Welch Allyn Quick Charger Conditioner Important To initiate a battery conditioning cycle 1 Insert the battery into slot 3 2 Press the red push button switch on the top of the charger behind slot 3 3 The red reconditioning light next to the push button will light indicating that the battery pack is being exercised At the end of the exercise period the charger will automatically begin a normal charge cycle and will illuminate the yellow battery light indicating that the battery is charging When the yellow battery light begins to flash the conditioning cycle is complete The red conditioning light will remain on until the battery is removed to serve as a reminder 9 4 Welch Allyn PIC30 Operating Instructions Powre Source that the battery has been
66. ess pacer up arrow to increase the pacing output current until capture is obtained Note If the defibrillator is charged the pacer will automatically turn off Welch Allyn PIC30 Operating Instructions Chapter Control Panel and Display WelchAllyn PIC30 z Size Lead MONITOR E gt E E m e gt A E 4 DEFIBRILLATOR E PACER did ad Select ba LL ELA v f E 3 EE E E E33 E 0 Overview of Interfaces es osse peser esa ge sa ER eR a 2 2 Overview of Controls and Display 2 3 Understanding ECG Monitoring Controls and Display 24 Understanding the Quick Access Buttons and Features 2 6 Understanding the Defibrillator Controls and Display 2 9 Understanding the Pacer Controls and Display optional 2 11 Understanding the Menu Controls lt 4 2 222 rre ri Ra Re Een 2 13 Welch Allyn PIC30 Operating Instructions 2 1 Control Panel and Display Overview of Interfaces 9 Front panel 1 System power switch bum 2 Display T Power supply defib tester and paddle holder 8 Annotating chart recorder 6 Defibrillator H release button L Le 5 Defibrillator connector 4 Battery slot Ge 3 ECG patient Ke cable connector System power switch Switch for main system power Display 6 4 16 2 cm screen that dis
67. f self tests and a Self Test Passed message will be printed on the chart recorder paper 6 Installed features will appear on the display after the self tests have been completed Standard features are ECG monitor and defibrillator Optional features are pacer and advisory function If you note any discrepancies please contact Welch Allyn with your model and serial number ADVISORY OPTION The PIC30 is available with an advisory ECG analysis option This option is an effective way of acquiring a second opinion of a patient s ECG condition within seconds Developed by Medical Research Laboratories the Advisory option analyzes a patient s ECG and displays a Shock Advised or No Shock Advised prompt within 4 16 seconds Welch Allyn PIC30 Operating Instructions 1 3 General Information 1 4 General Description FLEXIBLE DESIGN The PIC30 has been designed to allow additional options to be installed anytime in the future This system can grow with your needs SMALL LIGHTWEIGHT Weighing only 13 5 Ib 6 kg excluding battery and not much larger than a cardiac monitor this full function intensive care tool is ideal for transport portable applications LARGE 6 4 16 2 CM BRIGHT LCD DISPLAY A large bright display allows viewing the critical parameters from significant distance Safety Features A DH Je WARNING Electrical shock hazard DO NOT contact paddle electrodes or patient during defibrillation
68. g the button will safely discharge the defibrillator internally and the energy range bar display will disappear Note The unit contains an automatic disarm of the defibrillator If the operator has not delivered the energy to a patient or load an internal timer will disarm the defibrillator 1 minute after reaching a fully charged state O Synchronization Control Pressing the button activates the synchronization mode and illuminates the SYNC indicator light which flashes off when a QRS has been detected Sync will appear on the display and a SYNC marker will also appear over the portion of the ECG that the defibrillator will trigger on Pressing the Eme button again reverts to the asynchronous mode Note After synchronized cardioversion discharge E 18 Vi the defibrillator can be EU aa configured to remain in the Sync mode or revert to the asynchronous mode Sync marker Note The factory default Sync setting after EE ech Sync in the display asynchronous mode mn e Alarm Setup Log 2 10 Welch Allyn PIC30 Operating Instructions Control Panel and Display Understanding the Pacer Controls and Display optional a d WelchAllyn z 18 us i PIC30 sip x Size Lead A A MONITOR Ledid SET Li A H In Mr N S Set vw A Rate Ee Mode al NUM A O PACER ee Selected
69. gag pes Ranges Kala uie es 9 2 PIC30 Power Supply Paddle Holder optional Le 9 2 Battery Operation and Maintenance 9 3 Troubleshooting desea encore cee eer d e aq adr crie 10 1 Troubleshooting Basic Unit Problems e eser e rn 10 2 Troubleshooting Trace Problems ee se pere vee RAA doen 10 3 Recognizing and Reducing ECG Artifact 000000 10 4 Maintenance and SCroices soon cse sx enr AEN EA 11 1 Testing Equipment i 2is 3 040 eR ae ete ewe RE ES SER 11 2 Inspecting for Damage vac eee RERO erer 11 4 Functional lests a eq m Ue pie tos d Warde 11 5 Cleaning and Disinfecting the PIC30 en n AH du em RR Rn 11 9 Specifica HONS Lih es CURE LEEREN ea TER Ee 12 1 Welch Allyn PIC30 Operating Instructions Intended Use Warnings Cautions and Notices AN gt gt gt intended Use The Welch Allyn PIC30 is intended for ECG monitoring defibrillation and transthoracic external pacing and can be use by trained authorized medical personnel who are familiar with basic monitoring vital signs assessment and emergency cardiac care The PIC30 is also intended for use by physicians at the scene of an emergency or in a hospital emergency room Federal USA law restricts this device to use by or on the order of a physician It is highly recommended that any person using the PIC30 should have been trained in CPR or be ACLS certified and be completely knowledgeable of the information in this manual
70. ger Conditioner The Welch Allyn Quick Charger Conditioner is able to charge three standard Welch Allyn battery packs simultaneously in approximately 4 hours 1 To initiate a battery pack charge cycle insert the Welch Allyn battery into any of the three numbered slots in the front of the charger When the battery has been firmly seated into the contacts at the back of the slot the yellow light behind the slot will illuminate indicating that the battery is being charged This light will remain on for the duration of the charging cycle When the battery is fully charged the yellow light will flash to indicate it is ready for use N A completely discharged battery pack will require approximately 4 hours or less to recharge and a WelchAllyn SuperPac requires approximately 8 10 hours Charging time varies depending on battery capacity and state of charge Deeply discharged batteries and those with higher capacity will take longer to charge partially discharged batteries and those with lower capacity will require less time to charge Note Charging battery packs at temperatures above 30 C 86 F will prolong the charging time and may result in a gradual decline in battery capacity 3 If a fully charged battery is inserted into the charger it will be charged for a short period of time while the charger determines its state of charge When it is determined that the battery is fully charged the yellow light will begin to flash This proc
71. ghted energy range bar will include the selected energy C Sternum Welch Allyn PIC30 Operating Instructions 6 5 Defibrillation 8 If using paddles place the sternum paddle firmly against the patient s chest inferior to the patient s right clavicle and lateral to the upper sternum place the apex paddle in the anterior axillary line inferior and lateral to the patient s left nipple 9 To discharge hold the paddles firmly in place then press and hold both buttons down until the defibrillator discharges If using the hands free defibrillator pads press and hold the button on the multipurpose hands free adapter Note Discharge may not be immediate upon pressing the paddle buttons This is normal Keep the fire buttons pressed until the defibrillator discharges Note For any additional shocks the button may or may not need to be pressed This depends on the supervisor cardioversion mode setting 10 To negate the cardioversion after the buttons are pressed but before the next QRS wave is detected and the defibrillator discharges merely release both buttons The defibrillator will not fire When ready to defibrillate again firmly position the paddles then press and hold the buttons until a QRS wave is detected and the defibrillator delivers the energy 11 Press the button on the front panel to disarm the defibrillator at any time during the procedure 6 6 Welch Allyn PIC30 Operating Instructions
72. hasic waveforms such as the Edmark Lown and truncated exponential waveforms which have now been used in humans for over 30 years Starting in the early 1980s biphasic waveforms have been extensively studied in animal models of transthoracic ventricular defibrillation These studies have shown that a wide variety of biphasic waveforms exhibited superior defibrillation effectiveness to these conventional monophasic waveforms In many cases the waveform comparisons performed in animals were repeated in clinical trials involving humans These studies have conclusively demonstrated that well designed animal studies can and do predict the results that will be observed in humans Welch Allyn PIC30 Operating Instructions 12 11 Specifications The reasons for conducting animal trials as opposed to additional human clinical studies are 1 Animal studies can use a much larger sample size more shocks per subject and thus result in far more accurate comparisons 2 Animal studies do not place human subjects at risk from additional and clinically unneeded shocks 3 The animal hearts can be inspected for damage after the defibrillation studies WAVEFORM SAFETY AND EFFECTIVENESS CONCLUSIONS These scientific studies have demonstrated that 1 The data suggests that the MRL Orbital Biphasic waveform in the Welch Allyn PIC is at least as effective as and may be more effective than either of the two tested monophasic waveforms appeari
73. he pacer mode menu Demand Supervisor Diag Menu Supr Diagnostics SW Rev Menu Software Rev Menu Motherboard Displays the software version for the microprocessor in the ven PIC30 Preamp 5 XXXX Welch Allyn PIC30 Operating Instructions 3 13 Program Menu Setup Supervisor Setup Menu Supr Setup Line Freq Date Upgrade Language Code Printer Lead Menu Menu Password Menu Menu Menu Menu Line Frequency Menu The line filter frequency must be set to match the frequency of the NENNEN AC line current In countries where the line current is 60 Hz i e USA set the selection to 60 Hz In countries where the line current frequency is 50 Hz select 50 Hz A bold outline will appear around the selected frequency Date Format Date Format mm dd Date format is used to set how the month day and year will be d displayed dd mm yy mm dd yy month day year yy mm dd year month day To select a format press the corresponding button to highlight your choice then press Exit Language Menu The PIC30 display and chart printouts can be displayed in multiple languages To select a new language press the up and down arrows until the desired choice is displayed Then press Save to save your selection The unit must be powered off then on again for the language change to take effect To restore the PIC30 language setting to English press the Mute and VOL SS button at the same time 3
74. he pacing stimulus In the Async Mode pacing pulses are not dependent on the patient s cardiac activity The pacer will deliver pacing pulses at the selected pacing rate 12 Press the button to initiate pacing The pacing display will indicate PACING and the orange pacing light will change to green indicating the pacer is active Each time a pacing pulse is delivered to the patient the green light will flash off briefly 13 Ensure that the pacing pulses are occurring in the appropriate position of the cardiac cycle 14 Press the button to adjust the pacing current output Pressing the up arrow will increase the current by 10 mA Pressing the down arrow will decrease the current by 5 mA Slowly increase the output current while observing the ECG for evidence of electrical capture Check patient s pulse or blood pressure to verify mechanical capture Select the lowest output current that will achieve both electrical and mechanical capture Electrical Capture can be verified by noting a large ectopic beat approximately 100 msec after the pacing pulse is delivered to the patient The morphology of this pulse may vary widely from patient to patient sometimes appearing as a relatively normal QRS complex Mechanical Capture can be verified by monitoring the physical condition of the patient Check for the following physiological signs reddening of the skin palpable pulses increased blood pressure and other signs of increased blood flow
75. hen acquiring a pediatric ECG you may use an alternative V3 placement Place the sensor in the V4 position See figure above Improper placement will result in inaccurate waveform labeling 4 4 Welch Allyn PIC30 Operating Instructions Chapter ECG Monitoring Monitoring with Defibrillator Paddles ENEE 5 2 Monitoring with 3 lead Patient Cablessucccceeresacasaaawesdctves 5 2 Monitoring with 5 lead Patient Cables SNE sce nasantn n 5 3 Monitoring with Hands Free Defibrillation Pads optional 5 4 Welch Allyn PIC30 Operating Instructions 5 1 ECG Monitoring Monitoring with Defibrillator Paddles 1 Press switch on Set the to PADDLE PLACEMENT PDL paddles 2 Apply gel to paddles and place the sternum paddle firmly against the patient s chest inferior to the right clavicle and lateral to the upper sternum place the apex paddle in the anterior axillary line inferior and lateral to the patient s left nipple Sternum 3 Observe the patient s electrocardiogram on the display Adjust size of the ECG trace with the Apex control button as necessary Monitoring with 3 Lead Patient Cable 1 Press switch on 3 LEAD ELECTRODE PLACEMENT 2 Insure that the display indicates a 3 lead e patient cable has been configured If not see page 3 7 for setting patient cable type 3 Thoroughly prep patient skin for RAY nis electrode attachment Clean and dry skin or of sites preferably with a
76. here are no light indicators as on the SmartPak batteries due to space limitations inside the battery case Therefore use the battery status amp icon on the display to determine battery charge status MULTIPLE CONTACTS Switi error tree insertion Weld Allyn Backup reliability CAUTION T Importast talely considerations MRL QUICK HANGER High Capacity Battery a C 2 Te Do not UNDERSTANDING BATTERY CAPACITIES Each new battery is capable of 2 hours of monitoring or 40 360J shocks Over time and use the capacity of batteries will degrade Thus it is important to properly maintain your battery to maximize the battery s capacity throughout its life The amount of capacity degradation varies from battery to battery due to the conditions in which the batteries are used and maintained It is recommended that all batteries be replaced every 24 months Welch Allyn PIC30 Operating Instructions 9 3 Power Source CHARGING THE BATTERY Paddle Holder Charger The PIC30 charger is built into the the optional paddle holder area of the unit When installed the charger will charge a battery that is inserted into the PIC30 whenever the AC line power cord is connected to an outlet or the battery can be charged in the quick charger The yellow charge light on the paddle holder is illuminated continuously to indicate that a battery is charging The yellow light will flash whenthe battery is fully charged Welch Allyn Quick Char
77. ii AC Inlet LED Indicator for AC power Charger E a Death testi e j Paddle holder and defib tester PIC30 Power Supply Paddle t Holder optional ENTERO d pottery The PIC30 can operate from AC line or 8 Y battery power The AC line power cord is located in the back of the PIC30 and can be connected directly to any AC power source Ge CR i wc worldwide with the use of the proper a H a power cable Contact Welch Allyn Inc for LE ra ae era BS more information on the power cables to fit i your standard AC voltage E d AC Power Indicator The line power indicator is illuminated green when the unit is plugged into an AC outlet Charge Indicator Yellow light is illuminated continuously to indicate that a battery is charging The yellow light will flash when the battery is fully charged Defibrillator Test Indicator Green light is briefly illuminated to indicating that 200J or more has been delivered when testing the defibrillator Defibrillator Test Paddle Trays Paddle trays contain discharge contacts used for testing the defibrillator AC Inlet Connector accepts standard IEC 320 line cord with earth ground AC Power Cord A variety of cords are available to allow for connection of the PIC30 to virtually any worldwide AC line power source 9 2 Welch Allyn PIC30 Operating Instructions Power Source Battery Operation and Maintenance BATTERY PAK The batt
78. in the pacing Setup Menu See page 3 12 Rate Control Pressing the button selects the pacing output rate measured in beats per minute BPM Pressing the up Z arrow will increase the rate Pressing the down 7 arrow will decrease the rate When the pacing rate is below 100 BPM each press of the buttons will change the pacing rate by 5 BPM When the pacing rate is above 100 BPM each press of the buttons will change the pacing rate by 10 BPM Note The initial pacing output rate can be set in the pacing Setup Menu See page 3 12 Output Control Pressing the button selects the pacing output current measured in milliamperes mA Pressing the up arrow will increase the selected output by 10 mA Pressing the down arrow will decrease the selected rate by 5 mA Default is 30 mA Start Stop Control Pressing the button will allow pacing or pause the delivery of pacing stimulus to the patient When the pacer is in the paused mode a PACER STOP message will be displayed in the Pacer Window When the pacer is not paused a PACING message will be displayed in the pacer window Note Whenever a pacer or ECG lead fault occurs the pacer will automatically stop and a fault message will be displayed in the pacer window 2 12 Welch Allyn PIC30 Operating Instructions Pacer Fault Set Ld I II IH DEMAND Pacer Stop 60 BPM 30 MA DEMAND PACING 60 BPM 30 MA DEMAND Demand mode PACING 60 BPM 30 MA ASYNC
79. input source Hold Holds the traces on the display while pressing Welch Allyn PIC30 Operating Instructions 2 3 Control Panel and Display 2 4 Understanding ECG Monitoring Controls and Display Size Heart rate window T jV WelelyAllyn af 18 ECG PIC30 pee A j D 2 ies ES MONITOR Lead ick trol ii ei el LI LI awl Quick access controls GI DU J 1 Hold and windows pdt EES Ib v 1 DEFIBRILLATOR 5 A o mode lt 7Rate n ong lode ate A mi ton ners eee es ee R al 200 sx On Off j pH ES seen staristop Wesen Lm TUER S Sek I Vv 2 Disarm SE SE l C M CES CC E33 CS z Waveform window ECG monitoring functions on the PIC30 are viewed and controlled by the areas indicated above Note The following description and operation of the ECG monitoring portion of the PIC30 depict normal factory default settings Later in this chapter we will discuss user configurations of the ECG monitoring system Heart Rate Display 1 HR Indicates Heart Rate window 2 78 BPM indicates heart rate displayed in beats per minute flashing heart rate indicates an alarm limit has been exceeded 3 ECG abbreviation indicates the origin of the heart rate In this case the source of the heart rate is derived from the ECG electro
80. itioned so the inside or shiny side of the paper contacts the thermal array print head The spool should feed paper from the top 3 Pull out approximately 2 3 5 7 cm of paper and bring the free end of the paper around to the front of the swing out door then completely close the door 4 With the power switch on press the button and allow the paper to feed through the roller automatically Press Print again to stop paper feed Note If icon flashes on the display the paper is probably not moving freely through the slot in the door or the door is not completely shut Open the door and make sure the paper moves freely through the slot after closing the door again If the chart recorder runs but nothing is printed the paper is in backwards Rotate the spool so the inside of the paper contacts the print head Welch Allyn PIC30 Operating Instructions 1 7 1 8 General Information Summary of Operations CAUTION The Summary of Operations should be used as a reference only by those who have already read the User Instruction Manual Please read the User Instruction Manual completely before using the PIC30 SYSTEM SET UP AI AWN Se Press switch to OFF Connect appropriate options and accessory equipment Install charged battery or axillary AC power source Press switch to ON Clear log if the log gauge indicates a previous patient s events are in the log Verify that the configuration menus are
81. kin with alcohol and allow to dry completely before applying pads Check expiration date do not use pads that have expired Remove disposable multipurpose pads from packaging Use adult multipurpose electrodes P N 001853 for adult patients pediatric multipurpose electrodes P N 001828 for pediatric patients lt 10kg Remove the protective cover from the pads and apply the pads to the patient in the position illustrated or according to pad package Do not use if gel area is dry ies B Press button on the front panel up or down to select the desired energy level Wu Press the button on the defibrillator panel to charge the defibrillator An audible tone will sound periodically indicating that the unit is charging The energy range bar on the right side of the display will highlight the relative charge state until it reaches the selected energy When the unit is fully charged the periodic tone will change to a continuous tone and the highlighted energy range bar will include the selected energy 6 Visually and verbally ensure that all personnel including the operator are clear from the patient Press the button on the multipurpose hands free adapter to deliver energy 7 Observe the effect of the delivered countershock by observing the patient s ECG on the display The amount of energy delivered will appear in the defibrillation display window Verify that the proper amount of energy has been delivere
82. limit is exceeded the alarm condition and the time will be printed on the chart recorder 12 13 01 Miscellaneous Status Events Pre Certain system status events will generate L i a time stamped text printout on the chart recorder These events include Low bi ME battery defib disarm lead fault during pacing pacer off self test results advisory mode status time change and log full HR LOW ALARM Event Log Summary The Event Log provides a summary of key treatment events including defibrillator and pacing events ECG sample events alarms and system status The Event Log has a capacity of thirty eight 4 second ECG events and three hundred time stamped events Note Defibrillation events store 12 seconds of ECG consisting of three 4 second ECG events 4 seconds pre shock and 8 seconds post shock Pacing start events store 8 seconds of ECG consisting of two 4 second ECG events Sample To assist in providing a Summary of the incident the Sample button is available to document Advance Cardiac Life Support ACLS or other events Pressing the Sample button will store a 4 second ECG sample in memory along with the type of event time date as well as other status and annotation information Note If a subsequent ACLS treatment event button is pressed before the chart recorder has completed printing the information of the previous ACLS treatment event a low tone will sound indicating that the second event was not sto
83. logistic regression Welch Allyn PIC30 Operating Instructions 12 9 Specifications analysis Individual phase durations and overall pulse durations were measured and recorded on each shock Results The study consisted of 344 total fibrillation defibrillation episodes The mean ED50 and ID50 estimates to one decimal place are shown below The significance of difference p value was calculated by the Wald test in each case and are shown below Also shown are the mean total durations measured for each device Summary Table ED50 amp ID50 amp Duration Mean Monophasic Welch Allyn PIC 2kV Waveform Biphasic Biphasic Wavform ID50 Peak Current Amps 6 4 Significance of 0 001 0 001 difference p value PIC vs 2kV Monophasic PIC vs 2kV Biphasic ED50 Delivered Significane of 0 001 0 4937 difference p value PIC vs 2kV Monophasic PIC vs 2kV Monophasic Significane of difference p value 11 9 11 9 Study 2 Conclusion The MRL Orbital Biphasic waveform was as effective as the Biphasic 2KV waveform and more effective than the monophasic waveform While both biphasic waveforms required less peak current than the monophasic waveform the MRL Orbital Biphasic waveform required statistically less peak current than the 2 KV biphasic waveform defibrillator STUDY 3 Objective Comparison of the defibrillation effectiveness of the Welch Allyn Orbital Biphasic waveform defibrillator with a commer
84. ls must be used MANUFACTURER S RESPONSIBILITY Welch Allyn is responsible for the safety reliability and performance of the Welch Allyn Portable Intensive Care System only if the following three conditions are met Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by Welch Allyn The electrical installation of the relevant room complies with the appropriate requirements The PIC equipment is used in accordance with the instructions for use To ensure patient safety and proper operation use only Welch Allyn authorized parts and accessories FDA Medical Device Registration The FDA Safe Medical Device Act stipulates that each end user is required under penalty of law to register with the manufacturer all information pertinent to each medical device Please fill out the attached FDA Medical Device Registration postcard and return it promptly to Welch Allyn This card must be filled in and returned within 30 days of product delivery If the medical device is transferred from your possession you must notify Welch Allyn of the new registration information Please contact Welch Allyn 800 462 0777 if you have any questions regarding this notice Welch Allyn PIC30 Operating Instructions Declaration of Conformity Declaration of Conformity Manufacturer Medical Research Laboratories Inc Welch Allyn Ireland a Welch Allyn Company Navan Business Park 1000 As
85. mize interference locate the defibrillator and patient away from power cords and other electrical devices PREPARING THE SKIN Note In some cases skin irritation can occur from site preparation and sensor electrolyte solutions You are more likely to get a stable baseline and clean trace if you prepare your patient s skin properly at sensor sites For the best contact 1 Clean the skin with alcohol or acetone and let dry completely 2 Abrade the skin slightly with a dry heavy gauze or similar alternative 4 2 Welch Allyn PIC30 Operating Instructions Patient Preparation Applying ECG Sensors Apply sensors and connect the patient cable to them Make sure the lead cables follow the contours of the patient s body and lie flat If any lead wire is too long as with a short patient or child take up the length by making a small stress loop see figure p Stress Loop i d ht When applying sensors to sites with a lot of hair the following techniques may improve contact 1 Use the thumb and forefinger to spread the hair before applying the sensor to the skin 2 Abrade the skin slightly with a dry heavy gauze or similar alternative 3 If the sensor does not adhere well it may be necessary to shave the site Using Disposable ECG Sensors Disposable sensors save time and are an affordable alternative to bulbs plates straps creams and gels Disposable sensors utilize a highly conductive natural
86. mple y This is the menu which appears at startup From here the user can navigate through the program menus to set up unit functions Alarm Menu The alarm menu sets the heart rate HR alarm The HR alarms can be set to either OFF ON or AUTO The appropriate alarm icon appears in the heart rate window indicating the current state of the alarm Lower Limit Off 35 HR Alarm o Upper Limit 120 Lower Limit 35 Turning Off the HR Alarm To set the HR alarm to off press the Off On Auto button until Off is highlighted When the HR alarm is set to Off the upper and lower limits will each display Off and a number in parenthesis The number indicates the currently set HR limit that will be active when the HR alarm is turned back on Example HR alarm off the upper limit setting is 120 HR alarm off the lower limit setting is 35 Turning On the HR Alarm 1 Set the HR alarm to on by pressing the Off On Auto button until On is selected If the upper and lower limits are set the alarm on icon 4 will appear in the HR window and the global alarms will be enabled Set the upper limit The upper limit can be either set or disabled To set the upper limit press the upper limit button A bold line will appear around the box Press the up or down arrow to increase or decrease the upper limit value You can disable the upper limit by pressing the upper limit button again to display Disabled below the words Upper Limit Th
87. n 42 Applying ECG Sensors sese cese e Cal bin esa E ee e le naa 4 3 Using Disposable ECG Sensors 00 000 ccc cece eee 4 3 Welch Allyn PIC30 Operating Instructions 4 1 Patient Preparation Preparing Patients for ECGs You will obtain the highest quality ECGs when your patient is relaxed Assure your patient that there is no danger or pain involved and that his or her cooperation will assist in producing a valuable diagnostic record Make the patient comfortable on a cot or padded table which is large enough to support arms and legs The patient s arms should rest at his or her sides and the legs should lie flat not touching one another Use a pillow to support the patient s head Also try to avoid factors like cold drafts which could cause discomfort Leaving the chest and sensor sites exposed cover your patient with a blanket to prevent shivering CHOOSING THE ENVIRONMENT WARNING Explosion hazard DO NOT use in the presence of flammable anesthetics CAUTION Although the PIC30 is designed to meet IEC 601 1 1 2 EMC immunity requirements the presence of strong EMI field generated by electronic surgical or diathermy instruments close to the unit may cause trace noise or input overload conditions The PIC30 is a high fidelity instrument which responds to the minute voltages of the heart Since it is such a sensitive instrument take care to avoid interference which can be produced by muscle tremor and AC signals To mini
88. n determining the quality of the signal obtained Use high quality silver silver chloride electrodes These electrodes are designed to provide excellent baseline stability and rapid recovery from defibrillation and minimize artifacts from patient movement Do not use electrodes if gel is dry CAUTION When attempting to interpret subtle ECG changes ST segments etc use only the diagnostic frequency response mode Other frequency response settings may cause misinterpretation of the patient s ECG See Frequency Response section on page 3 6 for further details CAUTION Excessive artifact can be the result of improper skin preparation of the electrode sites Follow skin preparation instructions on page 4 2 CAUTION Do not operate the PIC30 in conjunction with electrocautery or diathermy equipment Such equipment as well as equipment that emits strong radio frequency signals can cause electrical interference and distort the ECG signal displayed by the monitor thereby preventing accurate interpretation of the rhythm CAUTION Do not operate the PIC30 in close proximity to any other monitor with respiration measurements The two devices could affect the respiration accuracy CAUTION The following caution is in accordance with the disclosure requirement of AAMI Standard EC13 1992 section 3 1 2 1m Certain line isolation monitors may cause interference on the ECG display and may inhibit heart rate alarms Note This caution is an AAMI req
89. nal jugular vein was cannulated and a bipolar pacing catheter was introduced under fluoroscopic control and advanced into the right ventricle The femoral artery was cannulated and an intra arterial line was placed for continuous measurement of arterial blood pressure The chest was shaved and defibrillating patch electrodes R2 part number 3200 1715 were placed on the left and right chest walls Fibrillation was induced by delivering 60 Hz current to the right ventricular electrode The energy required to defibrillate was determined by a protocol that has been used in several other biphasic comparison studies An initial shock strength of 50 to 70 joules was used If successful VF is reinduced after a 4 minute rest period and the shock strength is reduced by approximately 2076 for the next defibrillation attempt If the initial shock fails a rescue shock is delivered and after a rest period VF is again induced The energy is now increased about 20 for the next defibrillation attempt This procedure was continued until at least 3 reversals in result were observed with each waveform Two ED50 estimation procedures were run in parallel with the device being used alternated on each shock In practice actual clinical units were used so the energy steps were limited to those selectable on the devices tested Results The study consisted of 82 total fibrillation defibrillation episodes ID50 peak currents and ED50 delivered energies are shown below
90. ng to allow termination of fibrillation episodes using lower energies 2 The MRL Orbital Biphasic waveform in the Welch Allyn PIC is as effective as the 2KV biphasic truncated exponential waveform in another commercially available defibrillator 3 The MRL Orbital Biphasic waveform in the Welch Allyn PIC requires less peak current to achieve defibrillation effectiveness than either of the two monophasic waveforms or the 2KV biphasic truncated exponential waveform that is used in another commercially available defibrillator 12 12 Medic 6 Operating Instructions
91. nt when the ECG analysis is in process Take precautions to eliminate sources of motion or artifact before using the Advisory feature BATTERY CAUTIONS CAUTION Battery is shipped discharged Charge fully before use Charge time to 100 is approximately 4 hours CAUTION Use only Welch Allyn batteries in the PIC30 Use of any other battery can damage the PIC30 and or not provide sufficient power inhibiting patient care CAUTION Due to the critical dependency on batteries replacement of the battery is recommended at 24 month intervals due to self degradation of the battery chemistry Periodic maintenance and testing is highly recommended to ensure proper battery performance POWER SOURCE AND INTERNAL PIC30 DEFIB TESTER OPTIONAL CAUTION When testing the defibrillator ensure that the paddle surface is positioned properly in the paddle holder test well Do not use gel during this test When discharging the paddles into the tester press the paddles firmly onto the test points to prevent pitting the paddle surfaces CAUTION Do not take the paddle holder apart or attempt to repair it yourself CAUTION The power source should not be used in the presence of flammable anesthetics or materials NOTICES NOTICE A battery is not mandatory for operation of the PIC30 The PIC30 will operate from an optional AC power source alone Some defibrillation charging times will increase with no battery installed NOTICE Do not place a used batt
92. nted from the log event type Time ECG lead ECG Size and Heart Rate Bottom line Frequency and pacer status Defibrillation After the defibrillator has been discharged the chart recorder will automatically run for 12 seconds providing 4 seconds of pre shock ECG and 8 seconds of post shock ECG In addition the selected defibrillation energy will be printed A 12 second ECG sample will be stored in the Event Log Defibrillation QR DEFIBFIRED 200 JOULES 12 13 18 LEAD I 2cm mVA HR 65 A FREQ Monitor 0 5 to 40 Hz de Pacer Activation optional After the pacer has delivered pacing pulses the chart recorder will automatically run for 8 seconds providing 4 seconds of pre pace ECG and 4 seconds of post pace ECG In addition to the standard chart annotation the pacing rate output and mode information will be printed An 8 second ECG sample will be stored in the Event Log Pacer QR PACE ON 15 45 11 LEAD Il 2cm mv A HR 60 FREQ Monitor 0 5 to 40 Hz PACING 60BPM Q9 30mA Demand Analysis Event advisory option optional After the A Quick Access button has been pushed and an analysis cycle has been completed the chart recorder will automatically run providing a 6 second ECG trace A 4 second ECG sample will be stored in the Event Log 8 4 Welch Allyn PIC30 Operating Instructions Event Documentation Alarm Condition If the global alarms are enabled and a parameter s alarm
93. o severe depending on the patient s tolerance level muscle contractions and electrode placement In certain cases discomfort may be decreased by slightly relocating the pacing pads CAUTION It is important to monitor the patient closely to verify that both mechanical and electrical capture are occurring Electrical capture can be verified by observing the presence of a large ectopic beat after the pacing pulse is delivered The size and morphology of the beat are dependent on the patient In some instances the beat may appear as a relatively normal looking QRS pulse Mechanical capture can be verified by checking for signs of increased blood flow i e reddening of the skin palpable pulses increased blood pressure etc Continuously observe the patient during pacing administration to insure capture retention Do not leave the patient unattended when administering external pacing therapy CAUTION Some erythema of the skin and or minor burns may occur under the pacing electrodes in some patients For prolonged periods of pacing gt 4 hours periodically inspecting the skin beneath the electrodes when patient s condition allows is recommended Evaluate the patient s condition and if the skin is degrading discontinue external pacing if it is not required repositioning is not possible and or another form of pacing is available CAUTION Disposable defibrillation pacing electrodes must be used in accordance with the manufacturer s inst
94. ol is inhibited while pacing Advisory prompts are displayed in the lower half of the trace screen These prompts are listed below Analyzing LD II or Analyzing PADs Indicates the PIC30 is analyzing the patient s ECG to assess if it is a shockable rhythm Avoid touching or moving the patient Touching or moving the patient can cause artifact which may interfere with the analysis process Welch Allyn PIC30 Operating Instructions 2 7 Control Panel and Display No Shock Advised Indicates the PIC30 has completed analyzing the patient s ECG and that No Shock was advised Two BEEPs will be heard signifying the completion of the analysis Shock Advised Indicates the PIC30 completed analyzing the patient s ECG and that a shockable rhythm was detected The display will indicate SHOCK ADVISED The PIC30 will NOT automatically charge the defibrillator or shock the patient For instructions on how to defibrillate a patient refer to chapter 6 Motion Detected Indicates the PIC30 has detected motion artifact or noise Check electrode contact and make sure that the patient is motionless and personnel are not in contact with patient Attach Defib Pads Indicates that PIC30 has sensed that the defibrillator paddle set or pads are not attached properly Attach Electrodes Indicates the PIC30 has detected a lead fault on the patient cable ECG electrodes 2 8 Welch Allyn PIC30 Operating Instructions Control Panel and Display
95. plays ECG and other parameter information ECG patient cable connector Accepts 3 lead or 5 lead PIC30 patient cables Note Only use PIC30 patient cables Excessive artifact could result from use of non approved cables Battery slot Accepts PIC30 batteries Defibrillator connector Allows connection of external paddles hands free adapter or internal paddles Defibrillator release button Unlocks the defibrillation connector from the defibrillator to allow removal of external paddles hands free adapter or internal paddles Note When sliding the defibrillation connector on make sure the release button clicks into place and returns to its up position 7 Power supply defib tester and paddle holder Annotating chart recorder Use Welch Allyn approved 50 mm thermal paper Front panel Control panel with buttons for PIC30 operation 2 2 Welch Allyn PIC30 Operating Instructions Control Panel and Display Overview of Controls and Display 16 Monitor size 17 add lead 18 Monitor hold PIC30 ke gt MONITOR 1 Chart recorder fo Mute gt oY SI Display v e 11 2 Mute gt A gt 1 DEFIBRILLATOR E PACER 4 ZN Charge syne N f Mode 7 Rate A Energy PACER SC Select On O starustdp outpu AJ J VW am 3 AJ L3 L3 A ACA Pacer on off pacer 6 10 11 12 13 14 indicator Pacer Pacer 9 Qui
96. put Current ee nira 30 to 180 mA 10 or 5 mA whichever is greater Modes sses vou deas nero thapnantds Demand or Asynchronous Status Indicators ECG lead fault pace lead fault pace marker on monitor and chart start stop LED Pulse Type Aaen E A Rectangular constant current Pulse Width 2ossdbkt dass S i ids 20 ms Refractory Period 250ms Output Protection 360 Joules Option upgrade capability ee can be upgraded to add pacing option in the ield Advisory Module Optional Operations sess seke EE e ERES Pushbutton initiates a single ECG analysis cycle Advises defibrillation on VFIB or shockable VTACH Analysis Time pasera nerriseps tensi 4 16 seconds Outputs i eee rn ER Le eds Visual Display of Analysis results and prompts Prompts ese seen te ama Analyzing Stand Back No Shock Advised Shock Advised Motion Detected Lead Fault Attach Defib Pads Option upgrade capability Unit can be upgraded to add an advisory option in the field WELCH ALLYN QUICK CHARGER Mains Line Voltages 100 to 240 VAC four user selectable ranges 100 120 220 240 VAC Mains Line Frequency EE 50 to 60 Hz AC Power Consumption a ege stasis 50 W while charging batteries only 70 W while powering monitor 300 W while charging defibrillator Charger Bays A suave e e Rs Three charges three batteri
97. ral Desctiption ve ug aon eek he io eg er HUE ES eR Rp eere 14 Safety Features sos dog eer es eden tet haer due EE 14 Equipment Set i e een RR EDE etre de ede ee ae de os 1 5 Loading Recording Pap s esses 1 7 Summary of Operations jig e NEEN EEN Seer E s 1 8 Control Panel and Display amp 2 4 rr wean as awe 2 1 Overview of Interfaces sortari nk deg RI de gaer 22 Overview of Controls and Display 2 3 Understanding ECG Monitoring Controls and Display 2 4 Understanding the Quick Access Buttons and Features 2 6 Understanding the Defibrillator Controls and Display 2 9 Understanding the Pacer Controls and Display optional 2 11 Understanding the Menu Controls 4 6 565440 e EN ova acess teen 2 13 Program Menu Setup 8 8 e EELER G04 ENTREE EE 3 1 Basie Menu Structure o Dr eee em oi digs RR ERR RE bre 32 PIC30 Menu Heart Rate Alarm 3 3 PIC30 Menu Log Menu Sample and Bright Functions 3 5 Setup Menu ECG Configuration Menus 3 6 Setup Menu Grid Time Date and Supervisor Code Menus 3 8 Overview of Supervisor Menus 0066 ccc eee eee 3 10 Supervisor Defibrillator Menu 3 11 Supervisor Pacer Menu optional e NEEN ENEE EE EE es 3 12 Supervisor Diag Ment 026 cone RR ERE E eee AE OR ELE T 3 13 Supervisor Setup Menit ice cs er Cere ed be epe In E iet 3 14 Supervisor Upgrade Menu 3 16 Patient Preparation e Ae 5 cian es esse aw
98. red into the log or printed on the chart recorder Sample Event m QR Sample 12 13 00 Lead Ill 125cm mV A HR 65 Welch Allyn PIC30 Operating Instructions 8 5 Event Documentation 8 6 Clearing The Log To clear the event log press the Log button then f NEW PATIENT press Clear log A new patient header will be printed Name on the chart recorder and all events will be erased from EE the internal log 01 06 97 12 05 44 Print Log S N XXXXXX awe SE Emit So LR Aum Sep Sample x CJ EJ C01 C3 E EDU EA E Po Sample Event R SAMPLE 12 13 00 Lead Ill 125cm mV A HR 65 HH FREQ Monitor 0 5 to 40 Hz Log Full If the Log is full and the sample event button is pressed Sample will be printed along with Log Full The event will not be saved in the Treatment Summary log Log Full printouts should be saved and added to the log printout to provide a complete history of the event Printing out the Log A header is printed for each patient when the Log is printed out The header includes a place for the patient s name the time and date that system power was turned on the total number of ECG events stored for that patient the total number of defibrillator shocks delivered to that patient and the elapsed time the system was on The Log is followed by a printout of all the ECG samples stored for that patient At
99. rgy output is limited to 50 Joules Press Exit to return to the Supervisor menu Welch Allyn PIC30 Operating Instructions 3 11 Program Menu Setup 3 12 Sync After CV Charge Alarm Alarm Volume Sync After CV Menu The Sync after CV cardioversion menu allows the user to configure the defibrillator to stay in the sync mode after each synchronized cardioversion If the Sync After CV is off the defibrillator will revert to the asynchronous mode If the Sync After CV is on the defibrillator will remain in the Sync mode after each cardioversion Press Exit to return to the Supervisor menu Alarm Menu The Charge Alarm menu allows the user to select the Charge Alarm volume setting Press ALARM VOLUME to use the Volume icon in the Quick Access window to adjust the charging tone Press MAX VOLUME to set the charging tone to the maximum volume and by pass the Volume icon Supervisor Pacer Menu optional Supr Pacer Welch Allyn PIC30 Operating Instructions Mode Menu Rate Menu To set the default pacer rate setting press either up arrow to increase or down arrow to decrease the pulse per minute PPM selection Range is from 30 to 180 PPM Press Exit to close the pacer rate menu Program Menu Setup mode menu To set the default pacing mode press either demand or async Pressing either demand or async will highlight your selection with a bold surrounding box Press Exit to close t
100. rnative to the monophasic damped sine MDS waveform often referred to as the Edmark waveform defibrillator which was associated with higher peak currents and did not actively compensate for varying patient impedances In fact the MRL monophasic waveform defibrillator delivers less than half of the peak current of an MDS waveform defibrillator at equal delivered energies A new Welch Allyn defibrillator the Welch Allyn PIC has been introduced which offers a biphasic truncated exponential waveform that incorporates MRL s original low peak current impedance compensation design The MRL Orbital biphasic truncated exponential waveform has been extensively tested in multiple scientific safety and effectiveness studies Over 524 fibrillation defibrillation shock episodes have been conducted using the MRL Orbital Biphasic waveform comparing it to MDS MTS and another commercially available 2kV biphasic 360 J capable defibrillators Results of three of the scientific safety and effectiveness studies are summarized below STUDY 1 Objective To evaluate the MRL Orbital Biphasic waveform defibrillator against a monophasic damped sinusoidal waveform defibrillator Methods A canine model n 5 71 7 Ibs was used in a study that was approved by the Institutional Animal Care and Use Committee The animals were anesthetized with 20 mpk sodium pentothal i v and maintained as required through an intravenous catheter in the foreleg The exter
101. rt rate at time of setting DIVA PERDE RE TER 0 125 0 25 0 5 1 2 4 cm mV and auto ranging Aspect Ratio esee cae se ee Rd 0 05 0 1 0 4 0 8 1 6 per AAMI EC 13 1992 section 3 2 9 1f Welch Allyn PIC30 Operating Instructions 12 3 Specifications 12 4 Heart Rate Meter Response Time Heart Rate Response to Responds to a 40 BPM step increase in heart rate in 2 to 4 5 seconds per AAMI EC 13 1992 section 3 1 2 1 f Responds to a 40 BPM step decrease in 1 4 to 3 9 seconds per AAMI EC 13 1992 section 3 1 2 1 f Response times include a 2 5 second display update interval Irregular EE Complies with AAMI EC13 1992 section 3 1 2 1 e Ventricular Bigeminy Slow Alternating Ventricular Bigeminy Rapid Alternating Ventricular Bigeminy Tachycardia Response Time Alarms Heart Rate Alarm Lead Fault Alarm Mute Duration Enable Disable Recorder KEE Annotation 0 00000 8 Paper Width 1425 6b dees Paper Speed iios rer ten Welch Allyn PIC30 Operating Instructions 80 BPM expected 60 BPM expected 120 BPM expected Bidirectional Systole 45 BPM expected Response time to tachycardia alarm is on average 3 43 seconds with a range of 1 15 to 10 69 seconds per AAMI EC 13 1992 section 3 1 2 1 g Response times include a 2 5 second display update interval Audible 5 pulse 2 frequency 800
102. ructions Do not use expired dry electrodes or reuse disposable electrodes as improper patient contact may result in patient burns ineffective pacing and inability of the device to function properly CAUTION The pacing rate determination can be adversely affected by artifact If the patient s pulse and the heart rate display are significantly different external pacing pulses may not be delivered when required Ensure good ECG electrode contact CAUTION Artifact and ECG noise can make R wave detection unreliable affecting the HR meter and the demand mode pacing rate Always observe the patient closely during pacing operations Consider using asynchronous pacing mode if a reliable ECG trace is unobtainable ADVISORY CAUTIONS OPTIONAL FEATURE CAUTION Cardiac Pacemakers The presence of an internal cardiac pacemaker may adversely affect analysis results If it is known or suspected that the patient is fitted with a cardiac pacemaker follow your own locally established procedure for dealing with defibrillation of such patients CAUTION The Advisory mode should only be utilized on victims of cardiac arrest who exhibit unconsciousness absence of breathing and absence of pulse Welch Allyn PIC30 Operating Instructions v Warnings Cautions and Notices vi CAUTION Excessive motion may affect analysis results ECG analysis should not be performed when the patient is being moved Stop all patient movement and do not touch patie
103. ry cloth Next clean skin with alcohol and allow to dry completely before applying pads 4 Connect each lead of the 5 lead patient cable to the appropriate disposable electrode Arrange the electrodes as shown below Make sure that the ECG electrodes are placed to allow defibrillation if necessary The V or C lead may be repositioned as indicated to view V1 V6 5 Insert the patient cable plug into the input ECG connector on the PIC30 6 Select the proper lead setting for the desired lead configuration Press the button to the appropriate position corresponding to the desired configuration 7 Observe the patient s electrocardiogram on the display Adjust size of the ECG trace with the button as necessary For lead placement follow lead color code below Color lead AHA j IEC Right mid clavicular line between 6th Green RL i Black N and 7th intercostal space Red LL Green F Left mid clavicular line between 6th and i 7th intercostal space White RA j Red R Right mid clavicular line directly below 5 LEAD ELECTRODE PLACEMENT i clavicle Black LA i Yellow L Left mid clavicular line directly below i clavicle Brown V White C Chest Place per figure at left for V1 V6 V1 4th Intercostal space at right sternal margin V2 4th Intercostal space at left sternal margin V3 Midway between V2 and V4 leads V4 5th Intercostal space at mid clavicular line V5 Same transverse level as V4 at left
104. ry into the PIC30 Otherwise insert the battery into the quick charger The yellow charger indicator will illuminate indicating that the battery is being charged This light will remain on for the duration of the charging cycle When the battery is fully charged the yellow light will flash to indicate that it is ready for use CONNECTING THE PATIENT CABLE Make sure the connector on the cable is firmly pushed into the patient connector interface CONNECTING THE DEFIBRILLATOR ADAPTER Slide the adapter inward along the guide plate on the defibrillator interface Make sure the adapter is pushed snug against the plastic housing to assure a solid connection Apex Paddle Discharge button Defibrillator Adapter Defibrillator adapter release button Apex Paddle Note When sliding the defibrillator adapter on make sure the release button clicks into Discharge button e place and returns to its up position Charge button Pressing a will increase energy selection Pressing b will decrease energy selection Welch Allyn PIC30 Operating Instructions 1 5 General Information Multipurpose Hands Free Adapter and Electrodes optional 1 Multipurpose Pads 2 Pad Connector Hands Free Connects to patient connector 3 Patient Connector Accepts disposable monitoring defibrillation non invasive pacing pads B Multipurpose Hands Free Adapter Wu Hands Free Discharge Button oO Adapter Release
105. ry was cannulated and an intra arterial line was placed for continuous measurement of arterial blood pressure and for acquiring samples for arterial blood gas and electrolyte monitoring The chest was shaved and adhesive defibrillating electrode pads were placed on the left and right chest walls Fibrillation was induced by delivering 60 Hz current to the external electrodes The ED50 energy that required to defibrillate with 50 probability was determined by a protocol modeled after that of Dixon An initial shock strength of 30 joules was used which was applied after 15 seconds of ventricular fibrillation VF If successful VF was re induced after a 4 minute rest period and the shock strength was reduced by one energy step for the next defibrillation attempt If the initial shock failed a rescue shock was delivered and after a rest period VF was again induced The energy was now increased one energy step for the next defibrillation attempt This procedure was continued until a nominal sample size of six episodes was achieved both sides of the first reversal in result plus 4 episodes Three ED50 estimation procedures were run in parallel with the device being used alternated on each shock After each of the three independent ED50 estimation procedures had been completed the entire protocol was repeated twice more each time starting all devices at an energy of 30 joules The ED50 peak current and energy was then estimated for each animal by
106. s automatically selected for paddle monitoring applications Monitoring response is recommended for general ECG monitoring applications Filt Diag Filtered Diagnostic 0 05 40 Hz to choices of frequency response Diagnostic response should be used when attempting to interpret subtle ECG changes ST segments For optimal diagnostic response the line filter should be turned off Only Limited response is available when lead select is set to PDL Only Monitor and Limited response are available when lead select is set to PADS 3 6 Welch Allyn PIC30 Operating Instructions Program Menu Setup Filter Menu Line Filter On 60 Hz Filters In the Filter Menu the user can choose between line filter on or off by pressing the corresponding quick access button The currently selected line filter state is written below the words Line Filter The line filter frequency selectable from the supervisor menu is displayed in parentheses To choose a different line filter configuration press the corresponding quick access button Pressing Exit will return you to the Display Configuration Menu Line filters will remove AC mains line interferences emitted from power lines and other electrical apparatus Patient Cable Pt Cable In the Patient Cable Menu the user can choose between either 3 lead or 5 lead patient cable The currently selected lead configuration is highlighted with a bold outlined box To choos
107. s damaged in any way contact your local representative for replacement Visually inspect the cable for cracks stress marks and broken or bent pins Connect the patient cable to the PIC30 and attach each sensor lead to an electronic heart signal simulator such as the 3LD Simulator P N 980139 If a simulator is not available a test subject may be used Check the signal transmission through the cable by flexing the cable and electrode lead wires and observing the ECG rhythm for irregular tracings Note If using a test subject be sure not to disturb the sensor site since common baseline artifact will occur This should not be confused as a broken wire BATTERY TESTS AND RECONDITIONING It is important to test the batteries every 90 days to determine battery capacity for monitoring If batteries are charged in a high temperature environment above 30 C 80 F or normally encounter more than one charge discharge cycle per day recondition battery packs once every 30 days This test will help you approximate the amount of time available for monitoring when the battery icon is displayed Because this test completely drains the battery it also serves as an important reconditioning cycle that will help ensure maximum capacity Minimum Time hours 2 2 5 5 Capacity test perform test with a fully charged battery 1 Disconnect the unit from AC power 2 Turn on the monitor and note the starting time 3 Verify continued operation
108. set appropriately ECG MONITORING 1 Connect ECG patient cable multipurpose hands free adapter or paddles to the PIC30 System 2 Prep patient s skin H connect electrodes to patient 3 Select appropriate E 4 Adjust Size Size as necessary DEFIBRILLATING 1 Monitor patient s ECG on the display using the patient cable multipurpose hands free adapter or paddles 2 Apply gel to paddles or apply Multipurpose electrodes to patient 3 Select energy by pressing the up down buttons 4 Press button on front panel or on apex paddle deluxe paddles 5 After the defibrillator charges to the selected energy a continuous charge tone will be heard and the selected energy will be highlighted on the energy bar graph visually and verbally clear the patient area 6 Place the paddles firmly on the patient s chest at apex and sternum 7 To discharge the defibrillator press both buttons on the paddles or press the button on the multipurpose hands free adapter PACING NON INVASIVE PACING OPTIONAL 1 NS OT ge oo NI Monitor patient s ECG using the ECG patient cable and display Set lead to I II or III Apply multipurpose pads to patient as illustrated on the package Connect multipurpose pads to multipurpose hands free adapter Press pacer Far button to turn on pacer Press pacer button to select either DEMAND or ASYNC modes Press pacer button to select the desired rate Press pacer button to initiate pacing Pr
109. ss IIb C This symbol on the device indicates that the device meets the requirements of Council Directive 93 42 EEC MDD Class I UL Underwriters Laboratories Listed Device UL 544 Canadian Underwriters Laboratories Listed Device Welch Allyn PIC30 Operating Instructions vii Definitions of Symbols Used DISPLAY SYMBOLS Graphical and text icons listed below may be found on the display of the PIC30 during operation PPP PY iu Disable l o I SEHR Alarm oft Se Alarm on Log Alarm lower limit set Alarm upper limit set Automatic HR Alarm set Alarm push to disable Battery full Battery low warning Battery partially depleted N Calibration pulse aC P d x Check chart recorder viii Welch Allyn PIC30 Operating Instructions Auto heart rate undetermined Internal log gauge Mute QRS beeper off ORG beeper on Volume level Supervisor menu locked Supervisor menu unlock Notch filter On Brightness Advisory Optional Chapter General Information Congratulations on your purchase of a top quality Welch Allyn PIC30 defibrillator Your business is important to us If you would like more information or if you have any questions contact your local representative or call Welch Allyn Inc Technical Service Department at 800 462 0777 or 847 520 0300 CAUTION Federal law restricts this device to use by or on the order of a physician ACCESSOTIES 5 555
110. supplies for the next use defib gel recorder paper ECG electrodes etc 6 2 Welch Allyn PIC30 Operating Instructions Defibrillation Defibrillation with Pediatric Adapter CAUTION There is no energy limit for pediatric electrodes Care should be exercised to insure appropriate selection of defibrillation energy level for pediatric patients Note To facilitate rapid defibrillation for pediatric use the power on default defibrillation energy can be auto set in the supervisor defib menu 1 Shut the unit off before attaching the pediatric electrodes to the paddles 2 Slide the pediatric electrode onto the adult paddle set Be sure to slide the electrode to the end for a snug fit 3 Refer to page 6 2 and follow instruction for defibrillating with external paddles to defibrillate patient PEDIATRIC ELECTRODES Welch Allyn PIC30 Operating Instructions 6 3 Defibrillation Defibrillation with Multipurpose Hands Free Adapter optional Connect the multipurpose hands free adapter by sliding it onto the defibrillator guide plate Make sure the release button clicks into place and is in the up position 1 Press switch to On and ensure lead selector is set to PAD 2 Remove or loosen patient s clothing if necessary for application of pads Clean and dry skin sites preferably with a coarse dry terry cloth Shave patient if appropriate To remove HANDS FREE PAD PLACEMENT lotions or moisturizer clean patient s s
111. the auto HR alarm limits 4 You can view the upper and lower limits that were set by going back to the HR alarm menu The undetermined upper and lower limits have been replaced with automatically set values Note In either the On or Auto mode if the alarm parameters have been exceeded an audible tone will sound and the patient s heart rate measurement will flash in the heart rate window 3 4 Welch Allyn PIC30 Operating Instructions Lower Limit 48 B CG A gt gt Cp Dj IA Heart Rate Window Program Menu Setup PIC30 Menu Log Menu Sample and Bright Functions PIC30 Alarm Setup Log Sample 3 i 1 5 Log Menu This is the menu which appears at startup From here the user can navigate through the program menus to set up unit functions Log Menu To print out or clear the log press LOG to enter the Log Menu From the Log menu the user can print the log stop printing the log Print Log or clear the log To exit press Exit 0 To stop printing the Event Log while it is printing press Stop Print The information in the log will not be affected top Print To clear the Event Log press the Clear log button NEN Note To prevent a previous patient s Event Log Data from being printed with a new patient s data always clear the log prior to Clear Log treating a new patient Sample Pressing the sample button stores a 4 second ECG sample internally and prints Sample Event
112. the end of the ECG traces a System Off message will be printed along with the time the system was powered down If the system was powered down for more than two minutes a new patient is assumed and a new event summary is generated If the system is powered down for less than 2 minutes e g for a battery change it is assumed that the same patient is being monitored and subsequent events will be added to the current Log Multiple copies of the Log can be printed by printing the Log again after the System Off message is printed PIC30 EVENT SUMMARY nt Log Pri SYSTEM ON 01 01 99 12 34 01 SiS Baik TOTAL EVENTS XX p TOTAL SHOCKS XX ELAPSED TIME 0 01 12 S N XXXX Welch Allyn PIC30 Operating Instructions Chapter Power Source Katie Wb 3 i p Jl oa General Precautions coner zoe sah tates Syed Gea pude ph Ut 9 2 PIC30 Power Supply Paddle Holder optional 9 2 Battery Operation and Maintenance 9 3 Welch Allyn PIC30 Operating Instructions 9 1 Power Source General Precautions The PIC30 Batteries Do not incinerate Do not directly connect the negative and positive terminals together Use only the internal charger to charge the battery To prevent deterioration or damage to the battery Do not drop or subject to strong physical shock Do not use the PIC30 battery to power equipment other than the PIC30 AC Power Cord uM
113. ther electrical equipment including electrical beds and lighting fixtures may also generate interference even when not in use Try moving the patient to another place in the room Sometimes electrical wiring in walls and ceilings causes interference Welch Allyn PIC30 Operating Instructions 10 5 Chapter Maintenance and Service Testing Equipments ere sev onide sihr pennen p nE Hele we SE ee e 11 2 Inspecting for Damage 21 4 6 debuh o phe Cp esos 1a ean ck 114 Functional Tests hk xe ee epp EE ERR Rus 11 5 Cleaning and Disinfecting EE 11 9 Welch Allyn PIC30 Operating Instructions 11 1 Maintenance and Service Testing Equipment The Welch Allyn PIC30 performs a computer self test every time it is powered up Complete safety and component checks should be performed at least annually by a qualified service technician DAILY SHIFT CHECK PROCEDURE To insure the readiness and optimum working condition of the PIC30 the following inspections and tests should be performed daily or at each shift change In addition to daily monthly three month tests it is recommended that Welch Allyn performance verification procedure be completed by a qualified Biomedical Equipment Technician BMET every year or according to local requirements FDA Checklist An important part of a successful maintenance program is the creation of a maintenance log in which information is recorded on a regular basis This allows for verification
114. tly to the device Note Do not use cleaners which contain ammonia to clean the display Disinfection Gently rub the housing with INCIDIN or similar product THE PATIENT CABLE PADDLE SETS AND REUSABLE SENSORS NEVER immerse cables in fluid or use hot sterilization Do not use ether Do not use bleach acetone or similar harsh chemicals or solvents Cleaning and disinfection Rub with a clean cloth moistened with any of the recommended cleaning agents listed above Welch Allyn PIC30 Operating Instructions 11 9 Chapter Specifications Welch Allyn PIC30 Operating Instructions 12 1 Specifications General LEE 13 5 lbs 6 kg excluding battery DIZG cpu tae act A UM Ts 16 7 x 12 5 x 5 3 inches 424 x 318 x 135 mm Environmental Operating Temperature 0 to 45 C Storage Temperature 30 to 70 C Humidity Non condensing 15 to 95 RH Vibration 2secsesduickaee ae is MIL STD 810E Shick Diop iex os oro Ee iios ed MIL STD 810E Enclosure Protection 14 lt as lt niasas Solid Foreign Object IEC 529 IP2X Water IEC 529 IPX4 Atmospheric Pressure soe 15 000 Ft Altitude Tests performed per AAMI DF 2 Defibrillation Standard Defibrillator Waveform i secs ae ninnisi Precise Trapezoidal per AAMI Standard for Truncated Exponential Waveforms Waveform Details Peak current Ip and duration t at 360 Joules delivered energy The values shown are within 10
115. uirement that applies to all ECG monitors regardless of make or model CAUTION Do not use the auto gain setting for diagnosing asystole CAUTION Conductive parts of electrodes and conductors for applied parts should not contact other conductive parts including earth IEC 601 2 27 Welch Allyn PIC30 Operating Instructions iii Warnings Cautions and Notices iv DEFIBRILLATION CAUTIONS CAUTION After a synchronized cardioversion the SYNC mode can be configured to be cleared after each shock or disarm The user may have to reselect press the SYNC switch after each synchronized cardioversion shock performed on a patient The PIC30 can be configured in the Supervisor Defibrillation Set up menu to remain in the SYNC mode after each synchronized cardioversion CAUTION Synchronized cardioversion can be performed in the paddle monitoring mode However it is possible that artifact can be produced by the moving paddles which could cause the defibrillator to trigger on the artifact It is recommended that monitoring in leads I II or III be used during synchronized cardioversion Paddle monitoring should not be used for elective cardioversion procedures CAUTION To avoid damage to the defibrillator or the tester never attempt to repeatedly charge and discharge the defibrillator in rapid succession If a need for repetitive testing arises allow a waiting period of at least 1 minute for every third discharge CAUTION Monitoring EC
116. us 0 0 0 60 cece ccc eee eee 3 10 Supervisor Defibrillator Men 3 11 Supervisor Pacer Menu optional 2 sa 00 0805 n 3 12 supervisor Diag Men esser hated E Ra RETE ene 3 13 Supervisor Setup Menu 3 14 Supervisor Upgrade Mem eee EE EE nh ee a 3 16 Welch Allyn PIC30 Operating Instructions 3 1 Program Menu Setup 3 2 Basic Menu Structure Quick Access Buttons After selecting one of the menu buttons use the quick access buttons to navigate though the pop up programmable menus WelchAllyn PIC30 Size Lead A A MONITOR wot 9 DEFIBRILLATOR vVvvvvv N A PACER SS E TA moe Sato PACER 9898 kene Teens Menu Buttons Pressing the menu buttons allows the user to navigate through the PIC30 Menu options Alarm Setup Sample Brightens Printout Display Ecg Conf Menu Supr Pass Menu Supervisor Menu Defib Pacer Setup Diag Upgrade Key Alarms Alarms Bl Con menus L pico Pop up windows Welch Allyn PIC30 Operating Instructions Program Menu Setup lower limit set upper limit disabled upper limit set lower limit disabled Heart Rate Window Heart Rate Window PIC30 Menu Heart Rate Alarm Alarm Setup Alarm Menu PIC30 Log Sa
117. use the device to operate improperly and provide false measurements STERILIZATION Do not attempt to sterilize any accessory or any equipment part BATTERY CARE Proper care and maintenance of the batteries is important to insure continuous operation during portable use of the PIC30 If the batteries are not maintained properly loss of power during portable use could result affecting patient care DROPPED OR DAMAGED If this device has been dropped or damaged in any way refer the device to qualified service personnel for verification of performance and or servicing INGRESS OF LIQUIDS To achieve the specified level of protection against spilled or splashed liquids thoroughly dry all exposed surfaces of this device prior to operation or connection to mains power DISPOSABLE ELECTRODES When obtaining a new supply of disposable electrodes for monitoring defibrillation or pacing verify that they will properly connect to the existing cables prior to putting in service Do not use these electrodes if gel is dry Always verify expiration dates on dated items such as disposable defibrillation or pacing pads monitoring electrodes and battery packs If the expiration date has passed replace the disposable items immediately FERROMAGNETIC EQUIPMENT Biomedical equipment and accessories such as ECG electrodes and cables contain ferromagnetic materials Ferromagnetic equipment must not be used in the presence of high magnetic fields create
118. when AC line power is connected Chart recorder icon is flashing Pacer does not turn on 10 2 AC line power cord is disconnected Battery is depleted or defective Brightness and contrast controls need to be adjusted Paddle set is not connected to the unit Paddle set is not connected to the unit Bad line power wall outlet Failed power supply Bad line power wall outlet Failed power supply Battery missing or not properly seated Auxiliary power cable from paddle tray is not connected Failed charger No chart paper Paper jam Chart recorder door is open Hands free pad set not connected to unit Lead select set to PADS ECG or PADS lead fault Pacing option not installed in unit Welch Allyn PIC30 Operating Instructions Check power cord and AC PWR Light Replace Battery Adjust brightness and contrast using front panel controls Make sure paddle connector is properly seated Make sure paddle connector is properly seated Plug unit into different wall outlet Contact qualified service provider Plug unit into different wall outlet Contact qualified service provider Make sure battery is properly seated Connect Aux power cable Contact qualified service provider Replace chart paper Open door and clear paper jam Close chart recorder Make sure hands free connector is properly seated Set l
119. will include the selected energy Note If the selected energy is changed after charging has been activated additional time may be required to charge to the new energy 5 Place the sternum paddle firmly against the PADDLE PLACEMENT patient s chest inferior to the patient s right clavicle and lateral to the upper sternum place the apex paddle in the anterior axillary line inferior and lateral to the patient s left nipple Sternum 6 With the paddles in proper position clear all personnel visually ensure all personnel are clear including the operator from patient contact Press the button on each paddle simultaneously Note If defibrillation is not required D pressing the button located on the front panel will discharge the energy internally DELIVERED ENERGY Ld Del Energy 202 7 Observe the effect of the delivered countershock by observing the patient s ECG on the display The amount of energy 200 J delivered will appear in the defibrillation display window Verify that the proper amount of energy has been delivered 8 For additional counter shocks repeat steps 3 7 9 To secure the instrument turn the power switch to Off Clean the paddle electrodes patient cables and controls as outlined in chapter 11 10 If battery power was used recharge the battery by connecting the PIC30 to AC power or replace the used battery with a fully charged battery and check that there are sufficient

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