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User Manual, AED10 Automatic External Defibrillator

1. Main Menu Log Setup Setup Save Cancel Save Cance To change transmit mode 1 Access the Main Menu Select Log to display the Log Menu 2 Press the Next soft key to highlight Set Up Press the Enter soft key to display the Log Setup Menu 3 Press the Next soft key to change the transmit mode If using the SmartLink program select SmartLink If transferring the service log select Service See Working with the internal log on page 35 for more information 4 Highlight the Save box and press Enter to save the changes and return to the Log Menu 5 Toleave the transmit mode as it was originally highlight the Cancel box and press Enter to return to the Log Menu User Manual Programming 47 Supervisor Menu Supervisor Menu structure overview Supervisor CPR CPR Timer CPR Timer CPR Tempo 15 30 60 90 120 sorte Shock Mode Energy Language CPR Tempo M r 150 200 Save 90 95 100 105 110 ain Menu i 150 200 300 Cancel 115 120 Disable 150 200 300 360 Cancel Shock Mode Supervisor Menu Program 1 Shock CPR Restore Defaults 3 Shock CPR a 3 Shock Analyze Change Code Restore Defaults Unit ID Don Utility Change Code Bit Rate Current BPS Save Cancel 48 Programming Welch Allyn AED 10 Automated External Defibrillator Accessing the Supervisor Menu The Supervisor Menu is access
2. Unit ID Unit ID 000000000000 000123456000 To set Unit ID Cancel 1 While in the Supervisor Menu press the Next soft key to highlight Unit ID and then press the Enter soft key to go to the Unit ID Menu 2 Enter the desired Unit ID by using Next to scroll to the appropriate number and use Enter to shift to the next digit After the last character has been selected highlight Save by pressing Enter 3 Press Enter again while in the Save box to save the new Unit ID 4 To exit the Unit ID prompt without changing it press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu Note There are 12 available characters for the Unit ID 56 Programming Welch Allyn AED 10 Automated External Defibrillator Setting the department name The supervisor has the ability to assign a specific department name to the Welch Allyn AED 10 The AED 10 includes this department name number when reporting events so that it can be identified among other AEDs Dept Dept TOWNPOLICE 4 Save Cancel Save Cancel To set department name 1 While in the Supervisor Menu press the Next soft key to highlight Dept and then press the Enter soft key to go to the Department Menu 2 Enter the desired department name by using Next to scroll to the appropriate number letter or symbol and use Enter to shift to the next space After the last character has been selec
3. 3 Highlight Save by pressing Enter after the desired volume level has been selected Press the Enter soft key again to confirm the change and return to Main Menu 4 Toleave the volume at its original level press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Main Menu User Manual Programming 43 Adjusting the contrast The contrast of the Welch Allyn AED 10 liquid crystal display can be adjusted There are five pre set contrast levels available Use the Contrast Menu and the Next and Enter soft keys to change the LCD contrast Main Menu Volume Contrast Contrast Contrast To adjust the LCD contrast Cancel Cancel Cancel 1 Access the Main Menu Select Contrast to display the Contrast Menu 2 Press the Next soft key to change the contrast of the LCD The display contrast will change as the displayed value is incremented 3 Highlight Save by pressing Enter after the desired contrast has been selected Press the Enter soft key again to confirm the change and return to the Main Menu 4 Toleave the contrast at its original level press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Main Menu Setting the date Use the Date Menu to change the date Use the Next and Enter soft keys to change the date displayed Main Menu Volume Time ime u To set a new
4. Prior to using the Welch Allyn AED 10 the patient should be assessed by a trained person See Trained operators on page 26 If defibrillation with the Welch Allyn AED 10 is indicated all of the following signs should be present during patient assessment e Unconsciousness e Absence of breathing e Unresponsiveness no signs of circulation Contraindications The Welch Allyn AED 10 should NOT be used if the patient exhibits any of the following signs e Patient is conscious e Patient is breathing e Patient is responsive has signs of circulation 28 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Operating procedures Quick reference The following instructions provide an experienced operator with the main steps for using the Welch Allyn AED 10 Detailed operating information and procedures are provided in Operating procedures Detailed information on page 29 Users should refer to the Quick Reference Guide included with the Welch Allyn AED 10 Assess the patient Verify that the patient is unconscious is not breathing and unresponsive has no signs of circulation Even if the victim takes occasional gasps rescuers should suspect that cardiac arrest has occurred Proceed with treatment Start the Welch Allyn AED 10 and deliver a shock 1 Push the green ON OFF button located at the upper right corner of the Welch Allyn AED 10 next to the large number 1 2 Listen to voice pr
5. Apply defibrillation pads to the patient s bare chest Connect cable N User Manual Using the defibrillator 31 Analyze the patient s heart rhythm When the pads are properly applied and connected the Welch Allyn AED 10 announces and then automatically analyzes the patient s heart rhythm to determine if a shock is indicated N e Analyzing heart rhythm Do not touch the patient Caution Do not touch or move the patient while the Welch Allyn AED 10 is analyzing the heart rhythm Rhythm analysis takes approximately 8 to 16 seconds During this time any movement including CPR and patient transport may interrupt analysis and delay the defibrillation prompts Text and voice prompt will alert user if patient or defibrillation pads move e Analyzing interrupted Motion detected Deliver shock The Welch Allyn AED 10 will only administer a shock to a patient exhibiting a shockable cardiac rhythm All other rhythms are determined non shockable and therefore the patient is not a candidate for defibrillation If itis not a shockable condition the Welch Allyn AED 10 alerts the user with text and voice No shock advised N If a shockable condition is detected the Welch Allyn AED 10 alerts the user with text and voice e Shock advised iN To deliver a shock 1 Make sure the Shock button next to the large number 3 is flashing This indicates that the unit is properly charged A WARNING Make sure no on
6. X a Separate batteries from other disposables for recycling bad Recycle the defibrillator and battery separately from other disposables www welchallyn com weee This device has been tested and certified by the Canadian Standards Association International to comply SP with applicable U S and Canadian medical safety standards c KA This device has been tested and certified by the Underwriters Laboratories to comply with applicable U S us and Canadian medical safety standards C The CE Mark and Notified Body Registration Number signify the device has met all essential requirements 0197 of European Medical Device Directive 93 42 FEC 11 2 Introduction This chapter provides an introduction to the Welch Allyn AED 10 system and presents an overview of the Welch Allyn AED 10 controls indicators displays and prompts It also provides instructions for getting the Welch Allyn AED 10 ready for use and preparing the unit for storage Overview 2 AA OS ae n n e o OA 12 Features O KN Lue eoo seen ee eee eee E 12 Qualified eperators MP cc 12 Getting the Welch Allyn AED 10 ready 0 13 Unpacking and inspecting 4 40 o A A 13 Welch Allyn ABD O battery losses eee AA Be 13 Installing the battery 0 aaa ee aaa M v A 15 Running self testW oe eee m Mer 16 Getting to know the Welch Allyn AED 10 0 0 0 eee A 17 bi Tac o A 17 Gentrols cc ee A a eae 18 Display occ A Pag 19 T
7. 1 Open and carefully unpack each carton 2 Examine the instruments and accessories for signs of damage 3 Check the packing list to determine that all accessories have been received 4 Contact Welch Allyn see page ii if anything looks damaged or is missing Welch Allyn AED 10 battery The Welch Allyn AED 10 uses a single non rechargeable Lithium LIMNO gt battery pack which is specified to provide approximately 5 years of standby performance Depending on environmental conditions patterns of use and age the Welch Allyn AED 10 batteries will eventually begin to indicate a low battery condition Activities such as frequently turning on the device or leaving the device idle for an extended amount of time will decrease the life of the battery and accelerate the timeframe for the Welch Allyn AED 10 indicating Low Battery Verifying readiness To ensure the readiness of the Welch Allyn AED 10 it is important to respond immediately to low battery status indicators regardless of when they occur In addition to the self test performed by the device the defibrillator should be visually inspected weekly or monthly depending on the frequency of its use The Operator s checklist on page 64 should be maintained according to the schedule outlined below Frequency of Use Visual inspection schedule Monthly Weekly Infrequent i e once a year Monthly Check the battery readiness by verifying the defibrillator s status indica
8. FDA Welch Allyn has provided the following operator s checklist Automated External Defibrillator Operator s Checklist Infrequent use Non rechargeable battery Date Location Welch Allyn AED Serial No or Facility ID No Description OKasfound Corrective action Remarks Defibrillator Unit Clean no spills clear of objects on top casing intact Cables Connectors Inspect for cracks broken wire or damage Connectors are engaged securely and are not damaged Supplies Two sets of pads in sealed packages within expiration date Hand towel Scissors Razor Alcohol wipes Spare battery Power Supply Verify non rechargeable long storage life battery inserted and within the expiration date Verify that the system ready indicator shows READY Signature Print Name User Manual Maintenance 65 Inspecting and cleaning the Welch Allyn AED 10 A WARNING Do not autoclave or gas sterilize the defibrillator or any accessories WARNING Do not immerse any portion of the defibrillator in water or other liquids Avoid spilling any liquids on the defibrillator or its accessories Liquids may damage the defibrillator or present a fire or shock hazard Before cleaning the exterior of the defibrillator or any accessories thoroughly inspect them e Look for any signs of damage and any improper mechanical function of buttons or connectors e Immediately report any sign of damage or malfunction
9. 10 energy protocol provides a sequence of three defibrillator shocks The default protocol setting is 200 Joules 300 Joules and 360 Joules for the first second and third shocks respectively However the energy level for each shock is changeable Energy Save Cancel Cancel Save Cancel To set a new energy protocol 1 Access the Supervisor Menu Select Protocol to display the Protocol Menu 2 Highlight a field first second or third shock by using the Enter soft key Press the Next soft key to change the value of the energy for that shock 3 Highlight Save by pressing Enter after the desired energies have been selected Press Enter again to confirm the change and return to the Supervisor Menu 4 Toleave the energy protocol as it was originally press Next when the Save box is highlighted to select the Cancel box Press Enter to return to the Supervisor Menu Selectable Shock Energies for 3 Shock Protocol FirstShock SecondShock Third Shock 150 J 150 J 150 J 200 J 200 J 200 J 300 J 300 J 360 J User Manual Programming 53 Setting the shock mode The Welch Allyn AED 10 allows to choose from 3 different shock modes These modes are 1 Shock CPR goes into CPR mode after every shock 3 Shock CPR goes into CPR mode after every 3 shocks and 3 Shock Analyze for a non shockable heart rhythm continuously analyzes in the background Shock Mode Shock Mode Shock Mode 1 Shock CPR 3 Shock C
10. 39 Programming This chapter explains how to set the basic system operating options through the Main Menu It also provides information on accessing and setting the advanced system operating options using the Supervisor Menu Menu structure diagram RM aaa BM ER 40 Menu structure overview WEE Tb aaa RR RR EE 40 Accessing the Main Menu from startup es 40 Main Menu selections 0 ra 41 Main Menu structure OVEIVISW oe rs 41 Adjusting the volume ooo ll es 42 Adjusting th cOntfast 0 2c isses e A 43 Setting theidate YA ee ef A 43 Setting the time Mos mapa ote Adee et teed Gee ET PES 44 Transmitting or clearing the internal log raeo o ccc ee eee ee 45 Setting up the internal log 0 eee 46 Supesvisor Menu 2 0 gam a 47 Supervisor Menu structure overview w SPE a ee 47 Ace ssing the Supervisor Menu 4 TR MB A cc 48 Supervisor Menu items WII Y Se ee 49 Setting the CPR timer MMe a ccoo 50 Setting the CPR tempo PP MMM Meee ee eens 50 Selecting a language software revision 2 0 and later o oooo oooooo 51 Setting the energy protocol PERPE Y tissues n 52 Setting the shock mode 5 O cc 53 Changing the supervisor password 53 Restoring the factory default settings ce eee 54 Setting the Unit ID X NA occ RR cc ENDE 55 Setting the department name araara anaren 56 Setting the bitrate M coooococo
11. Allyn Protocol Inc Welch Allyn Inc 4341 State Street Road Skaneateles Falls NY 13153 Attn General Counsel Phone 315 685 2500 Fax 315 685 4496 1 Safety Conventions used in the manual AA MBA Baa aaa 1 General cautions and notice 4 A cc 2 Patient Safety iggy E AE a PAPAG apps 3 Defibrillator and electrode pads es 5 Battery care ESL PES OW Naa aa e n amp e A y Care and storage SEPITE cc RICE 8 Defibrillation pads MAB eee n m e RR ND 8 Safety symbol cee Mg hes ies Rb Rer or Mee a 9 Conventions used in the manual Warnings Warnings alert the user to a special condition that could result in serious personal injury or death Warnings are displayed as shown in the following example A WARNING Includes conditions hazards or unsafe practices that can result in serious personal injury or death Cautions Cautions alert the user to a special condition that could result in minor personal injury or damage to the equipment Cautions are displayed as shown in the following examples A Caution Conditions hazards or unsafe practices that can result in minor personal injury damage to the Welch Allyn AED 10 or loss of data AN Caution On the product this caution means Consult the accompanying documentation 2 Safety Welch Allyn AED 10 Automated External Defibrillator Notes Notes contain information that augments or clarifies an operating step Notes do not normal
12. Enter soft key to return to the Main Menu Note Setting the time forces a new patient into the entry log User Manual Programming 45 Transmitting or clearing the internal log A complete treatment summary including time stamped status events records of analysis results and pre and post shock ECG samples are stored in the internal log This information can be transferred to a personal computer via the AED 10 s infrared data port Also this data can be cleared from the log See Working with the internal log on page 35 for detailed information on Log functionality Main Menu Log SUM blink during transmit process Log Supervisor To transmit information stored in the log 1 Access the Main Menu Select Log to display the Log Menu 2 Transmit or clear the Log by using the Next soft key to select the desired action Press the Enter soft key to take that action The selection will blink during this process then the main menu will reappear 3 To exit to the Main Menu and not transmit or clear the log use the Next soft key to highlight Cancel Press Enter to return to the Main Menu 46 Programming Welch Allyn AED 10 Automated External Defibrillator Setting up the internal log The Welch Allyn AED 10 has two modes of transmitting the internal log to a PC Both methods utilize the infrared data port located on the front of the unit To select which method to use the user must access the Log Setup Menu
13. Note Do not open the sealed defibrillation pad pouch until the pads are ready to be used Note To remove the pads pull the wire connector upward from the device Note DO NOT REUSE PADS Store a new set of defibrillation pads in the carrying case electrode storage pocket located on the inside flap of the AED 10 carrying case Spare pads can be stored in the exterior pocket of the carrying case Make sure the pad expiration date can be viewed through the pad window of the carrying case When preparing your device for readiness be sure the status indicator is visible through the round window of the carrying case While in standby the Welch Allyn AED 10 automatically performs periodic self tests including the functionality of the unit and the status of the battery and internal circuitry A periodic visual inspection of your device should be performed on a weekly or monthly basis but should not include turning on the device since that will deplete the battery See Maintenance on page 59 for more information 24 Introduction Parts List Accessories Part Number 0 9 0185 2 0043 2 0185 3 01855 U 980150 E o e 01857 E 01858 E 02173 U 0213 7 0214 3 02169 E Welch Allyn AED 10 Automated External Defibrillator Part Welch Allyn Battery Pack AED 10 Heart Logo Carrying Case with pad expiration date windows AED status indicator window and EMS info card Welch Allyn Multipurpose Defibrillation
14. Test Electrical isolation Power Welch Allyn AED 10 Automated External Defibrillator 8 1 4 x 6 7 8 x 2 3 4 210 x 175 x 70 mm 3 025 1 37 kg pounds with battery 32 F to 122 F 0 C to 50 C 22 F to 158 F 30 C to 70 C Up to 95 non condensing Up to 15 000 feet 150 to 4570 m Mil Std 810F method 516 5 procedure 1 40G 6 9ms pulse 1 2 sine each axis Mil Std 810F method 514 5 category 4 IEC 60529 IP24 Mil Std 810F method 516 5 procedure 4 1 meter drop onto any edge corner or surface onto 2 hardwood over concrete Unit operates on internal battery only External Electrical Connections No external devices are attached to the unit Risk Current Category Data management Event Documentation Internal Memory Capacity Quick Report Communication Internally powered equipment with defibrillator proof BF type patient applied part as per definition of IEC 60601 1 standard Internal 1MB 250 4 sec ECG samples or 3000 time stamped events Treatment Summary Event Log Test Log RS 232 via Infrared IR port to PC or printer User Manual Defibrillator Output Energy Sequence user configurable Charge Time from Shock Advised Analysis Time Combined Analysis and Charge Time from power up after 6 shocks Audible Prompts Visual Prompts Controls Waveform Details Specifications 75 MRL Orbital Biphasic Truncated exponential Shock 1 150 J 200 J Shock 2 150 J 200 J
15. at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible What do do if the flashing low battery status indicator comes on at low temperatures If the AED 10 is subjected to cold temperatures near or outside of its low temperature operating limit of 32 F 0 C the low battery status indicator may be triggered even with a new battery The low battery indicator caused by cold temperature may cease when the device is warmed Discharging the device to defibrillate a patient may cause sufficient warming to eliminate the low battery indicator or cause it to be intermittent 13 Specifications Physical a a a iS TETTE o oe oes soe eee eee ee 74 Electrical isolation AP d WEE OO ee 74 Data management a E udi moo moo ee ee n 8 ap 74 Defibrillator PP ERE occ ERE 75 Pediatric energy reduce TA ri OR 76 Display OO ic ce eee ME 76 Battery ec II Up ooo v e v eee Res m e 76 Electromagnetig compatibility cesses e KG 77 Summary of studies of waveform safety and effectiveness 82 74 Specifications Physical Dimensions Weight Operating Temperature Storage Temperature without battery Humidity Altitude Shock Vibration Enclosure protection Drop
16. attempt to power up the device after a solid red circle with a slash appears in the battery indicator as described in Verifying readiness on page 13 B Solid black Ready 4 Flashing red circle Low battery Si Solid red circle Do not use Always check the status indicator after each use and replace the battery at the first opportunity if flashing A low battery condition does not render the unit non functional but indicates the battery is beginning to weaken Always have a fully charged battery backup available for use Always replace the battery every 5 years due to degradation of battery chemistry Perform regular maintenance checks of your device to ensure it is ready when needed Perform periodic visual inspections of your device on a weekly or monthly basis depending on frequency of use see Maintenance on page 59 for more information An Operator s checklist on page 64 is also provided for your convenience The following conditions will shorten or reduce battery life e Turning on the Welch Allyn AED 10 in non emergency situations Frequent device power ups to check the status of the device affect the life of the battery Battery capacity is diminished with every activation or power up of the device The device performs automatic self tests on a weekly and monthly basis to verify the readiness of your device therefore additional power ups are not required or recommended e Temperature extremes Harsh use
17. 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 logistic regression analysis Individual phase durations and overall pulse durations were measured and recorded on each shock 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 is shown below Also shown are the mean total durations measured for each device Summary table ED50 ID50 and Duration Conclusion Mean Monophasic Welch Allyn 2kV Biphasic Waveform AED 10 Waveform 1D50 Peak Current Amps 9 0 6 4 8 3 Significance of difference p value lt 0 001 lt 0 001 Welch Allyn AED 10 Welch Allyn AED 10 vs Monophasic vs 2kV Biphasic ED50 Delivered Energy Joules 40 2 21 4 22 7 Significance of difference p value 0 001 0 4937 Welch Allyn AED 10 Welch Allyn AED 10 vs Monophasic vs 2kV Biphasic Total Duration msec 11 9 128 13 1 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 statist
18. event log or 2 Setup the infrared port to transfer the log to the WA SmartLink tools Supervisor Enter the password code using the buttons below the Menu Bar to display the selections For each menu item selected the corresponding options replace the Main Menu on the left side of the LCD display If Supervisor is selected the user must enter the correct supervisor password to enter the Supervisor Menu selection screen Main Menu structure overview Main Menu Volume Volume Contrast 1 through 3 Contrast Date Time Date Month Day 2002 2040 Save 0 through 4 Save Cancel 0 c O Supervisor Cancel Time Cancel Password Save Cancel Clear Log 42 Programming Welch Allyn AED 10 Automated External Defibrillator Adjusting the volume The volume of the voice prompts through the Welch Allyn AED 10 speaker can be adjusted There are three preset volume levels available Use the volume screen and the menu selection button below the menu bar to change the volume of the voice prompts Main Menu Volume Volume Volume Volume Contrast Date Time Save Cancel Log Supervisor To adjust the volume 1 Access the Main Menu Select Volume to display the Volume Menu 2 Press the Next soft key to change the volume level As sound volume values are selected the sound volume will change immediately and a Beep sound will be heard
19. month it is recommended that authorized service personnel perform a periodic inspection servicing at least once per year Automatic self test The AED 10 will automatically perform a weekly self test while in standby mode with a battery inserted The AED 10 will also continuously monitor battery level During the weekly self test the following tests are performed battery main processor stuck key internal circuitry ECG acquisition system and defibrillator If a failure occurs during weekly self test it will be identified on the display accompanied by an audible notification After experiencing two consecutive low battery conditions during weekly self test the AED 10 will present visual and audible notifications The unit will then shut off for 30 seconds before entering into an annunciation cycle The annunciation cycle starts by having the AED10 wake up to deliver a single beep and a Low Battery voice prompt and then go to sleep for 30 seconds The AED 10 will wake up once more to deliver a single beep and a Low Battery voice prompt The AED 10 will then go to sleep for 17 hours before restarting the process The cycle will repeat for approximately two weeks or until the AED 10 is powered up to address the issue The status indicator located in the center of the device will remain flashing until the battery is replaced or the device is power cycled After two weeks the AED 10 will stop waking up to deliver the be
20. printer using your Windows based PC SmartLink Event Pro provides expanded features such as patient treatment data review ECG traces analysis results CPR information and an EMT D Narrative Report template Reports can be saved printed and sent via e mail 8 36 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Transmitting the internal log via the infrared data port Transmitting data via the infrared data port is fast and easy Using the Welch Allyn AED 10 Infrared Communications Kit Part No 00214 3 simply connect the infrared adapter cable to a PC serial communication port Next align the infrared adapter to the infrared data port on the AED 10 Infrared data port Infrared adapter To PC serial port Note Keep the infrared data port and adapter cable roughly 6 to 10 inches apart Note The bit rate of the AED 10 must be the same as the bit rate set in SmartLink to transfer the log Refer to Setting the bit rate on page 56 Start the SmartLink program on the PC and access the AED 10 main menu by holding down the lower menu soft key while powering on the unit Select the Log Menu and then select Smartlink The Smartlink selection flashes during data transfer Note See Setting up the internal log on page 46 and Transmitting or clearing the internal log on page 45 for more
21. replacement at 5 years is recommended due to degradation of the battery chemistry Caution Only turn on the Welch Allyn AED 10 when the defibrillator is to be used on a patient Avoid turning on the Welch Allyn AED 10 during non emergency situations Battery capacity is reduced with every activation or power up of the device Caution The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible Caution If the AED 10 is subjected to cold temperatures near or outside of its low temperature operating limit of 32 F 0 C the low battery status indicator may be triggered even with a new battery The low battery indicator caused by cold temperature may cease when the device is warmed Discharging the device to defibrillate a patient may cause sufficient warming to eliminate the low battery indicator or cause it to be intermittent 7 8 Safety Welch Allyn AED 10 Automated External Defibrillator Care and storage Caution Clean and maintain the Welch Allyn AED 10 according to instructions See Maintenance on page 59 Do not clean the Welch Allyn AED 10 with alcohol ketone or any flammable agent Do not autoclave
22. skin burns 4 Safety Welch Allyn AED 10 Automated External Defibrillator Electrical energy WARNING Welch Allyn AED 10 can deliver 360 joules of electrical energy Disconnect any medical electronic device that is not labeled defibrillation protected from the patient If this electrical energy is not discharged properly it could cause personal injury or death to the operator or bystander During defibrillation the operator and all other people must stand clear of the patient bed and all conductive surfaces in contact with the patient WARNING Properly place defibrillation pads Do not place defibrillation pads near the generator of an internal pacemaker Always apply defibrillation pads to flat areas of skin Avoid application over folds of skin such as those underneath the breast or on obese patients Excessive hair poor adhesion or air under defibrillation pads may produce burns ECG misinterpretation WARNING Properly place defibrillation pads Improperly placed pads may produce incorrect analysis and an inappropriate shock or no shock decision advisory WARNING Do not move patient Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis Follow all instructions in the Users Manual WARNING Cardiac pacemakers may affect rhythm analysis Patient pacemakers may reduce the sensitivity of the Welch Allyn AED 10 analysis and errors in detecting shockable rhythms WARNING Radio fre
23. the manual describes the operation of both the AED 10 and the JumpStart automated external defibrillators configured with the software indicated on the front of this manual Features e Two button operation e Extensive voice and visual prompts for the operator e Continuous event recording for reporting each use to a printer or computer e Weekly self test to ensure readiness e Biphasic energy output e Lock out protection to prevent inadvertent defibrillation e Continuous surveillance of battery level Qualified operators The Welch Allyn AED 10 permits trained users to administer a brief electrical shock to patients experiencing fibrillation or sudden cardiac arrest SCA A qualified operator is someone who has successfully completed a CPR AED training course e g AHA Heartsaver course or equivalent course provided by an accredited organization User Manual Introduction 13 Getting the Welch Allyn AED 10 ready Carefully unpack and inspect all the Welch Allyn AED 10 system components and accessories Install the battery Verify that the self test passes before putting the unit into service The device will perform an automatic self test upon being turned on Unpacking and inspecting Visually inspect the carton for any signs of damage or mishandling carton perforations cuts or dents bent or collapsed corners or broken carton seal Remove the Welch Allyn AED 10 from the carton and inspect it carefully Before proceeding
24. to your service department To clean the defibrillator 1 Make sure the battery is in place to keep liquids out of the battery contact area Make sure liquid does not get into the defibrillation pads connector 2 Wipe the equipment with a soft cloth slightly moistened not wet with one of the approved cleaning solutions listed in Table 2 Cleaning instructions and cleaning solutions on page 66 Do not use abrasive materials cleaners or strong solvents such as acetone or acetone based cleaners 3 Thoroughly wipe off any excess cleaning solutions Do not let the cleaning solution run into or accumulate in connector openings latches or crevices If liquid gets into connectors dry the area with warm air and check the equipment to confirm it operates properly A Caution Use only a cleaning solution recommended by Welch Allyn for this equipment Use of any other cleaning solutions which have a high acid content or are otherwise inappropriate can cause damage to the equipment including cracking and deterioration of the plastic case Caution Always follow the mixing diluting instructions provided by the manufacturer of the cleaning solution Caution Never use any of the following solutions or similar products to clean the equipment butyl alcohol denatured ethanol Freon mild chlorine bleach solution isopropyl alcohol trichloroethane trichloroethylene acetone Vesphene Il Enviroquat Staphene Misty Glutaraldehyde
25. 0 3 69 3 79 3 79 7 27 100 11 70 12 00 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people User Manual Specifications 81 Rhythm recognition performance Standards Performance The Welch Allyn AED 10 algorithm exceeds the requirements of ANSI AAMI DF39 1993 section 3 3 18 and the sensitivity and specificity levels recommended by the AHA Automated External Defibr
26. 0 will test the performance of its battery main processor stuck key internal circuitry ECG acquisition system and defibrillator Note The capacity of the battery is reduced with every activation or power up of the device The AED 10 performs automatic self tests on a weekly and monthly basis and therefore additional power ups are not required Inspecting for damage Inspect the Welch Allyn AED 10 and battery Look for signs of damage See Checklists for preparedness on page 63 for specific inspection requirements Contact an authorized service agent immediately if e The unit is not functioning properly e Accessories show signs of deterioration e The unit was subjected to extreme mechanical stress e Status indicator displays a Do Not Use icon Service and repair A WARNING Hazardous voltage To reduce the risk of electrical shock do not attempt to remove the cover under any circumstances There are no operator serviceable components and only a qualified technician should service the Welch Allyn AED 10 WARNING Do not disassemble the Welch Allyn AED 10 There are no operator serviceable components Service and repair should be performed only by authorized service personnel see page ii If a Welch Allyn AED 10 needs servicing contact an authorized service agent see page ii Be prepared to provide the following information e Model e Serial number e Description of the problem e Service log file If t
27. 300 J Shock 3 150 J 200 J 300 J 360 J 4 sec to 150 J 8 sec to 200 J 15 sec to 360 J 4 16 sec From start of analysis to shock ready Less than 20 seconds to 200 J Less than 30 seconds to 360 J 18 audible prompts 20 text screen prompts Four buttons On Off Shock and 2 software configurable buttons Table 1 provides details of the biphasic truncated exponential waveform delivered by the AED 10 set to Emax when connected to resistive loads of 25 through 175 2 The waveforms are characterized by typical values for peak current lp duration of the first output phase and duration of the second output phase pl T Table 1 hee o AM Tm en p 25 522 357 56 38 50 265 16 9 116 17 75 175 118 16 6 99 100 133 93 18 8 99 125 10 5 17 199 103 150 89 68 202 10 3 175 1 5 6 0 20 4 10 3 76 Specifications Welch Allyn AED 10 Automated External Defibrillator Output Energy Accuracy Nominal AED 10 energy delivery into load is given in Table 2 Accuracy into 50Q is the given nominal 10 Accuracy into 25Q 75Q 100Q 125Q 150Q and 175Q is the given nominal 15 Table 2 Load Energy selected 252 502 752 1000 1252 1502 1750 150 150 150 150 150 150 140 127 200 200 200 200 200 200 187 169 300J 300 300 300 300 283 254 230 360 360 360 360 318 283 254 230 Pediatric energy reducer Energy Attenuation Factor 25 at 25 Q 50 Q and 75 Q 20 at 100 Q and 125 Q 15 at 150 Q and 175 Q Display Ba
28. 800 289 2500 toll free in USA or 503 530 7500 Likewise if the defibrillator is retired from use or otherwise permanently disposed of please call and notify us and provide the date of retirement or disposition Manufacturer s responsibility ZOLL Medical Corporation is responsible for the safety reliability and performance of the Welch Allyn AED 10 only if the following conditions are met e Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by ZOLL Medical Corporation e The Welch Allyn AED 10 equipment is used in accordance with the instructions for use vi Preface Welch Allyn AED 10 Automated External Defibrillator User s responsibility The Welch Allyn AED 10 is intended for infrequent use only in emergency response situations by personnel who are authorized by a physician medical director and who have the following training and skills e American Heart Association Heartsaver course American Red Cross CPR AED course or equivalent e Training in the use of the Welch Allyn AED 10 The user should be completely knowledgeable of the information in the Welch Allyn AED 10 Users Manual Good judgment should be used when operating the Welch Allyn AED 10 To ensure patient safety and proper operation use only Welch Allyn authorized parts and accessories We recommend saving the AED 10 shipping container and packaging material for future use should your device require
29. AED 10 Automated External Defibrillator LA LOSS WN ac Sy User Manual Software version 2 07 XX WelchAllyn Advancing Frontline Care July 2009 9650 0145 01 Rev A ii Welch Allyn AED 10 Automated External Defibrillator O 2009 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn is a registered trademark of Welch Allyn AED 10 is a trademark of Welch Allyn Software in this product is Copyright Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remain with Welch Allyn or its vendors For information
30. EXBPTOMPTS sssr al SA TM a 20 Moice prompts ME ERE cc ce cee 20 System status indicator es EE ic os ene 21 Infrared data port PPP MB cc 22 Event documentation WEE A dc 22 Preparing the Welch Allyn AED 10 for readiness 0 0 ees 23 Kag AA EE NER 25 RD te ack Ia PCT 24 ACCESSOMES NM Lot AA 24 12 Introduction Welch Allyn AED 10 Automated External Defibrillator Overview The Welch Allyn AED 10 automated external defibrillator is a safe easy to use defibrillation device The unit is lightweight and mobile and can be used in situations where there could be several minutes before the arrival of advanced life support ALS personnel The Welch Allyn AED 10 recognizes ventricular fibrillation and other ventricular tachycardia and guides operators through the defibrillation process When properly connected to a patient who is unconscious not breathing and unresponsive without signs of circulation the Welch Allyn AED 10 analyzes the patient s heart rhythm provides text and audio instruction prompts determines if a shockable situation exists and if appropriate automatically arms the Shock button The Welch Allyn AED 10 delivers the defibrillation shock through two self adhesive pre gelled low impedance electrode defibrillation pads The pads cable and connector are sold as disposable kits Note Although this User Manual refers to only the AED 10 automated external defibrillator
31. GHz 80 to 800 MHz d 2 30 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with this symbol e n Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electrom
32. Next soft key to scroll through CPR tempo values 3 Highlight Save by pressing Enter after the desired tempo has been selected Press the Enter soft key again to confirm the change and return to the CPR Menu 4 Toleave the tempo as it was originally press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the CPR Menu Note Available CPR tempo values are 90 95 100 default 105 110 115 120 and Disable User Manual Programming 51 Selecting a language software revision 2 0 and later The language used for text on icons screen displays and voice prompts can be changed on the Welch Allyn AED 10 Language Language Language TE Reboot Save Cancel Save Cance Save Cance To select a different language 1 Access the Supervisor Menu Select Language to display the Language Menu 2 Press the Next soft key until the desired language is displayed 3 Highlight Save by pressing Enter after the desired language has been selected Press the Enter soft key again to confirm the change 4 To leave the language as it was originally press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu Note Changing the language will cause the AED 10 to reboot into automated mode 52 Programming Welch Allyn AED 10 Automated External Defibrillator Setting the energy protocol The Welch Allyn AED
33. PR 3 Shock CPR Save Cance Save Cancel Save Cance To set shock mode 1 Access the Supervisor Menu screen Select Shock Mode to display the Shock Mode Menu 2 Press the Next soft key to select different mode 3 Highlight Save by pressing Enter after the desired selection has been made Press the Enter soft key again to confirm the change and return to the Supervisor Menu 4 To leave the selection as it was originally press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu Changing the supervisor password Access to the Supervisor Menu is protected by a password The supervisor can change this password Change Code Change Code Cance To change the supervisor password 1 While in the Supervisor Menu press the Next soft key to highlight Change Code then press the Enter soft key to go to the Change Code Menu 2 Enter the desired new Password by using Next to scroll to the appropriate number and use Enter to shift to the next digit After the third number has been selected highlight Save by pressing Enter 3 Press Enter again while in the Save box to save the new password 4 To exit the Change Code prompt without changing the password press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu 54 Programming Welch Allyn AED 10 Automated External Defibri
34. Pads One Pair Welch Allyn Multipurpose Defibrillation Pads 10 pair Welch Allyn AED 10 Trainer with IR Remote Control Training Pads and Carrying Case Pre Attached Defibrillation Pads 1 pouch 2 pads Pre Attached Defibrillation Pads 1 box 10 pair AED 10 Pediatric Energy Reducer 002168 U carrying pouch and instructions for use Welch Allyn First Responder AED Prep Kit SmartLink Lite AED 10 IR Communications Kit SmartLink Event Pro AED 10 IR Communications Kit Notes Non rechargeable LiMnO battery Includes storage area for supplies such as spare pads batteries prep kit and pediatric energy reducer acquired separately Pads sealed in pouch with cable exposed Pads sealed in pouch with cable exposed For use with AED 10 devices only Additional supplies and accessories are available for your device Contact your local Welch Allyn representative or authorized distributor for more information 25 3 Using the defibrillator This chapter provides information for using the Welch Allyn AED 10 with a patient It also provides the instructions for operating the Welch Allyn AED 10 in automated or manual mode and describes the procedures to follow after using the unit Caution Read the Safety section at the beginning of this manual before proceeding with this chapter Overview e aao NEN OU a a e Mee Re 26 Trained operators e Mek Que ek ee cee Mee Ms S 26 Fibrillation and defiflagillationg UM AR 26 Indications
35. Welch Allyn AED 10 operator or supervisor can use a simple menu driven structure to set charge protocols and system configurations set system operating parameters such as display contrast and select the language used for text and voice 20 Introduction Text prompts Welch Allyn AED 10 Automated External Defibrillator Text prompts provide operating information and instructions The prompts display in the lower half of the LCD above ANALYZING ATTACH DEFIB PADS CHARGING BEGIN CPR MOTION DETECTED NO SHOCK ADVISED SHOCK ADVISED SHOCK NOW STAND CLEAR Voice prompts the status window Defibrillator pads are properly connected and the system is accessing the patient s heart rhythm Attach the defibrillation pads according to the instructions given on the package System is automatically charging the defibrillator to the energy level pre set in the shock protocol Begin a CPR cycle System has detected movement of the defibrillation pads or the patient as indicated by inconsistent data readings System has analyzed the patient s heart rhythm and determined that a shockable condition does not exist System has analyzed the patient s heart rhythm and determined that a shockable condition exists Prepare to administer the shock Defibrillator is charged and ready for shock Do not touch or move the patient The Welch Allyn AED 10 voice prompt feature provides instructional prompts to guide the user through the d
36. able on the devices tested User Manual Results Specifications 83 The study consisted of 82 total fibrillation defibrillation episodes ID50 peak currents and ED50 delivered energies are shown below for each group The mean impedance for these animals was 62 Q The mean ED50 energies were compared and were found to be significantly different The significance of difference p value was calculated by the Wald test in each case and is shown below The mean ED50 peak current for the biphasic waveform was 39 percent of that required with the MDS waveform Summary table ED50 and ID50 Conclusion Study 2 Objective Methods Mem WelchAlyn Monophasic _ AED 10 Damped Sine 1D50 Peak Current Amps 6 4 16 6 Significance of difference p value 0 001 ED50 Delivered Energy Joules 26 3 35 3 Significance of difference p value 0 014 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 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 A canine model n 6 61 6 5 5 lbs was used in a study that was approved by the Institutional Animal Care and Use Committee The animals were anesthetized with an intraveno
37. about any Welch Allyn product call the nearest Welch Allyn representative USA 1 800 535 6663 Australia 6129 638 3000 1315 685 4560 800 074 793 Canada 1 800 561 8797 China 86 216 327 9631 European Call Center 4 353 46 906 7790 France 4 3315 569 5849 Germany 49 747 792 7186 Japan 4 8133 219 0071 Latin America 4 1 305 669 9003 Netherlands 3115 750 5000 Singapore 656 419 8100 South Africa 2711 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Caution Changes or modifications not expressly approved by Welch Allyn could void the purchaser s authority to operate the equipment REF 9658 0220 40 Manual 9650 0145 01 Rev A 2009 07 EC REP ZOLL International Holding B V ZOLL Medical Corporation ewtonweg 18 269 Mill Road 6662 PV ELST Chelmsford MA 01824 4105 USA The Netherlands www welchallyn com Printed in USA Cop WelchAllyn Contents Preface ooo q REB cc V 1 Safety EE e eee om KAKA n e I eg 1 Conventions used in the manual 0 6 00 00 00 eee eae i General cautions and notices 0 eee 2 Patient safety O aaa EE 3 Defibrillator and electrode pads 1 o 5 Battervacare yc Mea Mis Wa heed sexes eee Aes xA RE ise Mes 7 Care andistorage o MN Lee ee MAS 8 Defibrillati n Pads ee eee AM 8 Safety symDelsy isses ee A 9 2 Introduction W iussa aes d d xc EG Ree NES 11 verview co MN Rede IRR a RUN 12 Getting the Welch Allyn AED 10 ready lili
38. ads to the Welch Allyn AED 10 Before applying pads to the patient s chest be sure to e Remove all clothing covering chest e Wipe off any water moisture or perspiration e Press the pads firmly to make sure they adhere securely to the chest 30 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Note To remove pads pull the wire upward from the device Note DO NOT REUSE PADS A WARNING Excessive body hair may affect the operation of the defibrillation pads or cause skin burns on the patient Remove body hair as needed to ensure that the defibrillation pads make proper contact with the patient s chest To attach defibrillation pads and connect the cable 1 Open the package containing the defibrillation pads and cable 2 Peel off the backing from the defibrillation pad labeled RA Place this pad just below the patient s right collarbone sternum as illustrated on the AED 10 pad placement illustration 3 Peel off the backing from the defibrillation pad labeled LL Place this pad over the ribs on the patient s left side below the breast apex as depicted on the pad placement illustration 4 Plug the pad connector into the Welch Allyn AED 10 on the left side of the unit Connect the cable from the defib pads Note If the pads are not properly applied or if the cable is not properly connected to the Welch Allyn AED 10 it will alert the user with text and voice e
39. agnetic site survey should be considered If the measured field strength in the location in which the Welch Allyn AED 10 is used exceeds the applicable RF compliance level above the Welch Allyn AED 10 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Welch Allyn AED 10 C Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 80 Specifications Welch Allyn AED 10 Automated External Defibrillator Recommended separation distances between portable and mobile RF communications equipment and the Welch Allyn AED 10 IEC 60601 1 2 Table 205 The Welch Allyn AED 10 is intended for use in an environment in which radiated RF disturbances are controlled The customer or the user of the Welch Allyn AED 10 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Welch Allyn AED 10 as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 150kHzto80MHzin 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of outside ISM bands ISM bands transmitter W d 3 5 3 P d 12 10 P d 12 10 JP d 23 10 JP 0 01 0 17 0 12 0 12 0 23 0 1 0 37 0 38 038 0 73 1 1 17 1 20 1 20 2 3 1
40. am a cioe 73 Physical aaa eR mr 74 Electrical isolation 0 amm oaa es 74 Data management o 74 Defibrillator AE ES Soo eee 75 Pediatric energy reducer 2 2 ee 76 Display EUA A Oe aa 76 Battery 6 065 sy o MEERN a W on GA KGG KGG cum 76 Electromagnetic compatibility 77 Summary of studies of waveform safety and effectiveness 82 B Glossary BG Waaa 87 Preface Important Read this Operators Manual carefully as it contains important information concerning your safety and the safety of others when using this Automated External Defibrillator It is important that you are familiar with the operation and controls before operating the product Manufacturer ZOLL Medical Corporation Product Name Welch Allyn AED 10 Device Type Automated External Defibrillator Medical device registration Welch Allyn and its distributors are required by FDA medical device tracking regulations and other national regulatory authorities to maintain records of end users that purchase Welch Allyn s defibrillators Please provide us with the information requested in the device registration card to assist us in complying with the defibrillator tracking requirement and to enable us to contact you promptly in the unlikely event that there is a problem with your defibrillator If you transfer the defibrillator to another person or company please notify us of the new owner by calling Welch Allyn at
41. ance WARNING Properly use defibrillation pads Do not attempt to warm the defibrillation pads with a heat source greater than 35 C 95 F Do not immerse or clean defibrillation pads with alcohol or solvents Do not perform chest compressions CPR through defibrillation pads These actions may damage the defibrillation pads and cause the AED 10 to function improperly WARNING Use only accessories approved by Welch Allyn Do not use defibrillation pads batteries and other accessories not approved by Welch Allyn Use of unauthorized accessories may cause the device to operate improperly and provide false measurements Follow all labeling instructions on the defibrillation pads and the battery Caution Do not repeatedly charge and discharge the defibrillator in rapid Succession If a need for repetitive testing arises wait at least 1 minute for every third discharge to avoid damaging equipment Caution Improper maintenance can cause improper performance Follow instructions in the Users Manual User Manual Battery care N Safety Caution Use only Welch Allyn batteries Use only Welch Allyn Part No 001852 U non rechargeable lithium battery Use of any other battery can damage the Welch Allyn AED 10 Caution Always verify remaining capacity of a non rechargeable battery after use Check capacity and change if battery is low See Maintenance schedule on page 62 Caution Replace the battery at 5 years Battery
42. and contraindications for use 2 eee 27 Operating procedures Quick reference 2 eee 28 Assess the patient 2 2 cee eee esM 28 Start the Welch Allyn AED 10 and deliver a shock 0 0 000000 cee 28 Begin CPR Start with chest compressions a an asaan cerae 28 Operating procedures Detailed information 0 000 000 ee eee 29 Assess the patient MA TEE eee 29 Start the Welch Allyn AED 10 E A A ac 29 Apply defibrillation pads to the patient s bare chest and connect cable 29 Analyze the patient s heartrhythm o o Eeoa 31 Deliver Shock A222 D ci 31 Defibrillator disarm TES TEES eo o Qe aa RI 33 Check the patient s condition and perform CPR 0 33 Shock mode i e Meso aa x O o Nh ll la a Naa RARE 34 Post use procedures Wa ye ye AM rs d aa 35 Working with the intermal leg 2 0 00 cee aaa eee o PER 35 Transmitting the internal log via the infrared data port 2 00005 36 Storing the Welch Allyn AED 10 for reuse 0 eee 37 26 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Overview The Welch Allyn AED 10 is capable of operating in an automated mode In this mode the operator must be trained to use the unit and understand the indications and contraindications for use Trained operators The Welch Allyn AED 10 is intended to treat patients in cardiopulmonary arrest It is for
43. aste Prepare it for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If the defibrillator or battery LiMinO2 is contaminated this directive does not apply For more specific information see www welchallyn com weee or contact Welch Allyn Customer Service page ii Recycle defibrillator batteries LiMnO2 according to the Directive 91 157 EEC Batteries and accumulators containing certain dangerous substances and Directive 93 86 EEC Labeling of batteries and accumulators containing certain dangerous substances Outside the European Union KG When the defibrillator or the battery LiMnO2 reaches end of life recycle it locally according to national state and local regulations or return it to Welch Allyn 68 Maintenance Welch Allyn AED 10 Automated External Defibrillator 69 Troubleshooting This chapter provides information on how to troubleshoot situations and conditions that arise during the operation of the Welch Allyn AED 10 and gives answers to frequently asked questions Overview SR aaa aaa TERT 69 Attaching defibrillation pads TMB AM aaa aaa aaa EE 69 Analyzing interrupted APM A ee eee eee a a E 70 No shock delivered TEF K aaraa araara ee Ree 70 Defibrilat r x ke Ba ak MR em o Be 2 71 Battery MX WELL Kana ee AM NN 71 Other problems X AK 0 lp
44. bare chest e Then connect the cable to the AED 10 3 If prompted deliver shock by pressing the flashing red Shock button 1 Poweron 2 Textand voice prompts 3 Shock Power ON OFF Green ON OFF button to toggle system power on off Shock Red Shock button to discharge defibrillator red LED flashes when defibrillator is fully charged Menu selection Two soft buttons located to the left of the display programmable functionality to make menu selections in programming mode User Manual Display Introduction 19 Text prompts patient data and event information display on the liquid crystal display LCD screen The display is a backlit monochrome liquid crystal display LCD measuring 160 x 100 pixels The display is divided into five functional areas Operating information and user instructions display in these areas Elapsed Shocks time counter Text prompts Shocks counter Displays the number of shocks administered to the current patient Text prompts Displays up to three lines of text user instructions directions for patient care error messages See descriptions below Elapsed time Displays the time elapsed since the system was powered ON or time used on current patient The time format is HH MM SS Status Displays various system status prompts such as Charging and Energy Delivered Graphical screen icons provide system operational information The
45. cal 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 alternative 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 defibrillator the Welch Allyn AED 10 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 To evaluate the MRL Orbital Biphasic waveform defibrillator against a monophasic damped sinusoidal waveform defibrillator A canine model n 5 71 7 lbs was used in a study that was approved by the Institutional Anima
46. cumentation below for details Infrared data port Event documentation The Welch Allyn AED 10 stores event documentation including patient status ECG traces and treatment summary The information is stored in an internal log Event documentation is time stamped and can be downloaded to a computer and printed through the infrared data port on the Welch Allyn AED 10 The AED 10 IR communication kit with Smartlink Lite Software 002143 or AED 10 Communication Kit with Smartlink Event Pro Software 002169 E is required to produce an event report User Manual Introduction 23 Preparing the Welch Allyn AED 10 for readiness After each use any rescue event documentation should be retrieved from the internal log and printed Error messages or malfunctions should be reported and corrective actions taken before redeploying the device The Welch Allyn AED 10 should be inspected and cleaned in accordance with recommendations in this User Manual see Maintenance on page 59 Used defibrillation pads should be removed from the device and replaced with new defibrillation pads Check battery readiness by verifying that the AED 10 status indicator located to the left of the green power button is in a ready to use state If the status indicator is flashing a red circle with a slash through it 8 this indicates a Low Battery situation Replace battery with a new battery pack betore redeploying device
47. date 1 Access the Main Menu Select Date and display the Date Menu 2 Highlight a field month day or year by using the Enter soft key Press the Next soft key to change the value of the field 3 Highlight Save by pressing Enter after the desired date has been selected Press the Enter soft key again to confirm the change and return to the Main Menu 4 Toleave the date as it was originally press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Main Menu Note Setting the date begins a new patient record in the entry log 44 Programming Welch Allyn AED 10 Automated External Defibrillator Setting the time The Welch Allyn AED 10 time stamps events and saves them to the internal log A 24 hour clock is used for time displays e g 15 30 is used for 3 30 p m Use the Time Menu and the Next and Enter soft keys to change the hours and minutes Main Menu To set a new time Cancel Cancel Cancel 1 Access the Main Menu Select Time to display the Time Menu 2 Highlight a field hours or minutes by using the Enter soft key Press the Next soft key to change the value of the field 3 Highlight Save by pressing Enter after the desired time has been selected Press the Enter soft key again to confirm the change and return to the Main Menu 4 Toleave the time as it was originally press Next when the Save box is highlighted to select the Cancel box Press the
48. e 81 All other rhythms are determined non shockable and the patient is not a candidate for defibrillation Cardiopulmonary resuscitation CPR medication and supplemental oxygen may also be required to effectively resuscitate the patient User Manual Using the defibrillator 21 Indications and contraindications for use Once the Welch Allyn AED 10 is connected via the defibrillation pads to the patient the instrument assesses the patient s cardiac status and indicates whether the patient is a candidate for defibrillation The Welch Allyn AED 10 will only administer a defibrillation pulse shock to a patient exhibiting a shockable cardiac rhythm All other rhythms are non shockable and the patient is not a candidate for defibrillation Cardiopulmonary resuscitation CPR medication and supplemental oxygen may also be required to effectively resuscitate a patient This defibrillator should not be used on patients less than 8 years old or under 25kg 55lbs unless it is equipped with the accessory AED 10 Pediatric Energy Reducer Welch Allyn 002173 U Defibrillation may be effective against cardiac arrhythmias such as e Cardiac arrest e Ventricular fibrillation e Ventricular tachycardia e Other cardiac rhythms with ventricular rates equal to or greater than 160 beats per minute and amplitudes of at least 0 099 millivolts mV Note The Welch Allyn AED 10 has not been evaluated for cardioversion of atrial fibrillation Indications
49. e is touching the patient before you press the Shock button Loudly announce Stand back Do not touch the patient and look down the entire length of the patient to ensure there is no contact with a bystander or conductive surface before pressing the Shock button Stand clear AN Shock now Press the red button now AN 2 Press Shock to deliver a shock 32 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Shock button Note The Welch Allyn AED 10 does not allow the operator to charge or discharge the defibrillator unless a shockable rhythm is detected After delivering a shock the Welch Allyn AED 10 prompts for immediate CPR Note In the 3 shock cycle configuration the AED 10 continues to analyze the heart rhythm and determine whether additional shocks are indicated User Manual Using the defibrillator 33 Defibrillator disarm If the defibrillator is charged and the Shock button is not pressed the Welch Allyn AED 10 must be disarmed e The defibrillator discharges automatically in 30 seconds After 25 seconds a warning tone indicates that the defibrillator will disarm automatically e The operator can press the ON OFF button and turn off the defibrillator Check the patient s condition and perform CPR If the heart rhythm is not treatable with defibrillation the Welch Allyn AED 10 displays and announces the message No Shock Advised e No
50. ed from the Main Menu Main Menu Password Password Cw 000 Supervisor To access the Supervisor Menu 1 While in the Main Menu press the Next soft key to highlight Supervisor and then press the Enter soft key to go to the Password Menu 2 Enter the Password by using Next to scroll to the appropriate number and use Enter to shift to the next digit After the third number has been selected highlight Save by pressing Enter 3 Press Enter again while in the Save box If the password is correct the Supervisor Menu will appear If the password is incorrect the Main Menu will appear 4 To exit the Password prompt press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Main Menu Note The default supervisor password is 1 2 3 User Manual Programming 49 Supervisor Menu items Supervisor 1 Supervisor Menu Restore Defaults Utility CPR Set the value for CPR Timer and or CPR Tempo Language Select text and audio language The Welch Allyn AED 10 will reboot into automated mode to activate selected language Protocol Select the energy level protocol Default protocol is 200 300 360 Joules Shock Mode Selects among 1 Shock CPR default 3 Shock CPR or 3 Shock Analyze mode Program Allows the user to update to the current version of Welch Allyn Restore Defaults Unit ID Dept Change Code Bit Rate Utility AED 10 software via
51. eee MA 71 Frequently Asked QUESTIONS c ooooooocooooooora BK 72 Overview If the built in sensors in the Welch Allyn AED 10 detect a problem prior to or during operation the unit provides a voice or screen prompt indicating the problem Use the information in the following tables to troubleshoot The tables list fault indicators and determine possible corrective actions Note In some situations the operator will be instructed to change the battery or defibrillation pads It is important to always have spare batteries and other accessories available Attaching defibrillation pads Indicator Possible Cause Corrective Action Defibrillation pad does not adhere properly to the patient Wipe moisture from chest and or shave excessive hair from chest Defibrillation pads are dry damaged or out of date Replace the defibrillation pads Improper pad placement or pads touching each other Check pad placement make sure pads are in the correct location Inadequate connection to AED 10 Check for proper insertion of defibrillation pads connector into AED 10 Pads connector not connected or properly inserted into the Push pads connector firmly into the connector socket connector socket Poor defibrillation pad contact with the patient s bare chest Press firmly on defibrillation pads to improve adherence to patient s skin Troubleshooting Analyzing interrupted Welch Allyn AED 10 Automated External Defibrillator Indica
52. efibrillation process without relying solely on text prompts The Welch Allyn AED 10 provides audio instructions through the built in speaker to provide operating instruction and assist the user during defibrillation The voice prompts listed in the following table parallel the text and icon displays shown on the LCD Analyzing heart rhythm do not touch the patient Analyzing interrupted motion detected Apply defib pads to patient s bare chest connect cable Apply defib pads connect cable Begin CPR Low battery No shock advised Shock advised Defibrillator pads properly attached and connected assessing heart rhythm Patient or defibrillation pads moved At unit power up Attach defibrillation pads to the patient and connect cables to the Welch Allyn AED 10 Defibrillator pads are not properly attached to the patient or properly connected to the Welch Allyn AED 10 Begin a CPR cycle Low battery charge Replace battery Shockable condition does not exist Shockable condition exists Shock now press the red Push the red SHOCK button button now User Manual Introduction 21 Stand clear Defibrillator charged and ready to shock do not touch or move patient Stop CPR Stop CPR wait for further instructions It is safe to touch the Defibrillator shock has been delivered patient Shock not delivered Attempted shock did not deliver any energy to the patient System status indicator The system status indicator d
53. elch Allyn AED 10 and Clean the Welch Allyn AED 10 If damaged remove AED pad connector for any signs of damage 10 from service and contact Welch Allyn customer service Make sure that all supplies and Do not use damaged or expired supplies or accessories accessories are present and in proper Replace any used supplies and accessories such as operating condition Inspect the razors gloves and pads defibrillation pad packages and battery packs for install before dates and any signs of damage Note The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible Check battery Check the battery capacity shown in the system status indicator see System status indicator on page 21 If Low Battery is indicated remove the battery and replace with a new battery Dispose of the battery properly according to local authority disposal standards Always verify that a fully charged spare battery is available for use Note The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low batter
54. ent 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 monophasic waveforms such as the Edmark Lown and truncated exponential waveforms that 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 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 tha
55. ents associated with heart muscle activity EMS emergency medical services erythema redness of the skin fibrillation rapid twitching movements that replace the normal rhythmic contraction of the heart and may cause a lack of circulation and pulse joule the amount of energy delivered during defibrillation related to the intensity of the shock delivered 88 Glossary Welch Allyn AED 10 Automated External Defibrillator LCD liquid crystal display AED 10 screen log list of ECG samples and time stamped system events nonshockable rhythm patient heart rhythms that are not a candidate for defibrillation pulse NSR normal sinus rhythm Primary AED AED 10 mode that provides text and voice prompts protocol see defibrillation protocol RF radio frequency SCA sudden cardiac arrest self test automatic test performed at system power up to check readiness of battery internal circuitry main processor and defibrillator shock defibrillation electrical pulse shockable rhythm abnormal heart rhythm which is a candidate for defibrillation pulse tachycardia an abnormally fast heart rate time stamped event any change in heart rhythm or any shock delivered by the defibrillator
56. ep and LOW BATTERY notifications and will revert to only supplying a failure beep and tone at the end of the weekly test If the failure was a fatal error other than a low battery the unit will act the same as described above except the beep and LOW BATTERY prompts will be replaced by two beeps The cycle of the AED 10 sleeping for 30 seconds and waking up to notify the user will repeat six times instead of twice These six dual beep notifications will be repeated every 17 hours for approximately two weeks or until the AED 10 is powered up by the user to address the issue The System Status indicator will remain flashing until the battery is replaced or the device is power cycled The System Status indicator will display the red DO NOT USE indicator If both a low battery and another fatal error are detected during the self test the user will get both audible notifications described above User Manual Maintenance 61 The user can stop these notifications by powering up the unit and addressing the problem If a self test failure is detected the System Status indicator will display the red DO NOT USE indicator If the failure was only a low battery the indicator will flash rather than display a solid DO NOT USE indicator Note The user MUST power the AED 10 on via the power button to clear a low battery error Simply replacing the battery will not always clear the fault At power up and automatic self test the Welch Allyn AED 1
57. gy level is preset when operating the Welch Allyn AED 10 in Automated Mode What do do if a shock is advised while am transporting a patient Avoid shocking a patient during transport movement may interfere with the accuracy of the rhythm analysis Stop the transport if possible and allow the Welch Allyn AED 10 to reconfirm the shockable condition How can tell the status of the battery Refer to System status indicator on page 21 for battery capacity specifications When the unit is in storage battery capacity will diminish over time The Welch Allyn AED 10 continuously monitors and reports battery capacity while in storage The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity What do do if need to use the defibrillator and have a flashing low battery status indicator The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible What do I do if the flashing low battery status indicator comes on during use The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced
58. have excessive hair from chest Replace the pad if needed Press Shock button within 30 seconds Automated Mode or 60 seconds Manual Mode after the ready message Check the connection to the AED 10 User Manual Defibrillator Battery Troubleshooting 71 Indicator Possible Cause Corrective Action AED 10 operates but LCD is too dark or too light AED 10 turns off or will not turn on Battery depleted or disconnected Displayed time or date is incorrect Electrical radio frequency interference Operating temperature is too low or too high Adjust the contrast setting Reinstall or replace the battery Reinstall or replace the battery Change the AED 10 time setting Verify that time is correct after a power ON OFF cycle Move hand held communication devices or other suspected devices away from the AED 10 Operate the AED 10 between 0 to 50 C 32 to 122 F Indicator Possible Cause Corrective Action AED 10 needs service Depleted battery No display or messages after ON button is pushed Replace battery If condition is not corrected contact authorized service personnel Replace battery If condition is not corrected contact authorized service personnel Replace battery If condition is not corrected contact authorized service personnel For battery recycling information see Recycling defibrillator components on page 67 Note Depending on e
59. he Welch Allyn AED 10 needs to be returned for servicing use the original shipping container If the shipping container is not available contact Welch Allyn for packing instructions prior to shipping This will help minimize damage during shipping 62 Maintenance Welch Allyn AED 10 Automated External Defibrillator Maintenance schedule General Caution Improper maintenance may cause the Welch Allyn AED 10 to malfunction Maintain the Welch Allyn AED 10 as described in this manual Prepare a customized maintenance schedule for the Welch Allyn AED 10 to reflect how the unit will be used The schedule should account for how often the unit is used and where it is used In addition the schedule should consider how familiar the operators are with the operation of the unit Here are some guidelines for preparing a maintenance schedule at your facility Frequency Observe Action After each use and during each inspection After each use Check the system status indicator Verify If the system status indicator is flashing replace the that the ready to use status indicator on battery If a solid red symbol appears turn on the AED 10 the front of the unit is operating if possible and note the self test results If a Self Test Failure is indicated remove AED 10 from service and contact Welch Allyn customer service If the AED 10 wil not power on replace the battery as it is probably drained Inspect exterior of W
60. ically less peak current than the 2 kV biphasic waveform defibrillator User Manual Study 3 Objective Methods Results Specifications 85 Comparison of the defibrillation effectiveness of the MRL Orbital Biphasic waveform defibrillator with a commercially available Biphasic 2kV defibrillator capable of 360 J in a simulated higher impedance model A canine model n 6 53 7 6 1 lbs 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 20 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 about 20 for the next defibrillation attempt This procedu
61. ies that are not provided by Welch Allyn This indemnification is expressly conditioned on the Purchaser s fulfilling the following obligations with respect to any claim for which indemnification will be requested the Claim The Purchaser will send to Welch Allyn at the address shown below written notice of the Claim promptly after the Purchaser obtains knowledge of the Claim The Purchaser also will provide to Welch Allyn all assistance reasonably requested by Welch Allyn for evaluation of the Claim or defense of the Claim Such assistance will include 1 providing to Welch Allyn possession of the Welch Allyn AED involved in the Claim including any electronic record created by the Welch Allyn AED of the event involved in the Claim for analysis of the cause of any failure and 2 providing to Welch Allyn and its counsel all other evidence relevant to the Claim whether in the form of documents or testimony Welch Allyn will promptly notify the Purchaser in writing if Welch Allyn determines that the Claim is not covered by this indemnity and Welch Allyn shall have the unrestricted authority to defend or settle any Claims for which indemnification is required by this agreement However the Purchaser shall retain the right to participate at its own expense in the defense or settlement of any Claim that is covered by this indemnity viii Preface Welch Allyn AED 10 Automated External Defibrillator Address for notification of claims Welch
62. illators for Public Access Use Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance The test database includes shockable rhythms consisting of ventricular fibrillation rhythms gt 99 vV and wide complex ventricular tachycardia at a rate greater than 160 BPM Non shockable rhythms include various sinus rhythms including supraventricular tachycardia atrial fibrillation atrial flutter sinus rhythm with PVC s asystole pacemaker rhythms and ventricular tachycardia with a rate less than 160 BPM and or narrow complexes Rhythm Class ECG Test Performance Goal 90 one sided Conclusion Sample Size lower confidence level Shockable VF 90 gt 90 sensitivity 97 2 Meets the AAMI DF39 requirement and AHA recommendation Shockable VT 33 gt 75 sensitivity 84 6 Meets the AAMI DF39 requirement and AHA recommendation Nonshockable NSR 349 gt 99 specificity 100 Meets the AAMI DF39 AHA requirement and AHA recommendation Nonshockable 10 gt 95 specificity 100 Meets the AAMI DF39 asystole requirement and AHA recommendation Nonshockable all 242 gt 95 specificity 97 8 Meets the AAMI DF39 other rhythms requirement and AHA recommendation 82 Specifications Welch Allyn AED 10 Automated External Defibrillator Summary of studies of waveform safety and effectiveness Introduction Study 1 Objective Methods Over 30 years ago Medi
63. information The Welch Allyn AED 10 also stores a service log used for keeping track of system information If any error messages or malfunctions occur the service log can be transferred to SmartLink and then sent to Welch Allyn service technicians for review The internal log retains its data after transmitting to the PC and may contain data from multiple incidents Therefore it is recommended that the user clear the internal log after successfully transferring its contents Any error messages or malfunctions should be reported and corrective actions taken before storing the unit for reuse User Manual Using the defibrillator 31 Storing the Welch Allyn AED 10 for reuse After each use the Welch Allyn AED 10 should be inspected and cleaned with a new supply of defibrillation pads restocked to prepare the unit for its next use Any event documentation should be retrieved from the internal log and printed Note When using the Welch Allyn AED 10 carrying case store new defibrillation pads to ensure proper viewing of the system status indicator During storage the Welch Allyn AED 10 performs periodic self tests including the functionality of the unit and the status of the battery and internal circuitry A more detailed test of defibrillator operation and battery status should be performed on a regular basis See Maintenance on page 59 for more information 38 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator
64. is 13 Getting to know the Welch Allyn AED 10 00 0000 cee eee eee 17 Preparing the Welch Allyn AED 10 for readiness 0000 23 parts List 2 A ee een 24 3 Using the defibrillator Hr ccoo 25 Overview 78989 A ee 26 Operating procedures Quick reference 0 00 0 ee 28 Operating procedures Detailed information naonao aaa anaana aaran 29 Post use procedures A Qoo esee n Res 35 4 Programming Wyss dichos a rho RR ERR dd 39 Menu structure di grammwf 4 gt aaa aaa aaa a E 40 Menu structure Overview eooo eee 40 Accessing the Main Menu from startup n 0 0 0 0 ee eee 40 Supervisor Menu 7 MB ee A 47 Be MaintegaNge 2 XX as Ana a paani bk kakabahan MR ex Dy 59 IngSpeetioni ics essen eR RR herd RE EN AA 60 Maintenance Schedule 62 Inspecting and cleaning the Welch Allyn AED 10 0 0 0 eee 65 Recycling defibrillator components aaaea aa 67 6 Troubleshooting 0 0 00 c eee ees 69 Overview XX a ee A Me Rm 69 Attaching defibrillation pads 2 0 ee eee 69 Analyzing interrupted HA TR a Ta 70 No shock delivered afe ES ee 70 iv Contents Welch Allyn AED 10 Automated External Defibrillator Defibrillator Bo ez NE ee 71 Battepy y eo eme eM eee o IAM 71 Other problem ooccocccccco Me Mee eMe 71 Frequently Asked Questions eee 72 B Specifications sa aure eor aw E E P
65. isplay located in the center of the Welch Allyn AED 10 represents the operational readiness of the battery System status indicator Ready e Battery is properly installed charged and system is ready for use Do Not System is not ready for use Battery may not be properly installed Use battery charge is too low for effective operation or system failure Flashing e Battery is low and requires changing Note The flashing low battery status indicator means that the battery is beginning to weaken and should be replaced at the first opportunity The AED 10 remains operable when the flashing low battery is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible Note If the AED 10 is subjected to cold temperatures near or outside of its low temperature operating limit of 32 F 0 C the low battery status indicator may be triggered even with a new battery The low battery indicator caused by cold temperature may cease when the device is warmed Discharging the device to defibrillate a patient may cause sufficient warming to eliminate the low battery indicator or cause it to be intermittent 22 Introduction Welch Allyn AED 10 Automated External Defibrillator Infrared data port The built in Infrared Data Port provides a wireless connection to the Welch Allyn IRDA device See Event do
66. l 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 external 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 20 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 select
67. llator Restoring the factory default settings The Welch Allyn AED 10 has the option to revert all user configurable settings back to the original factory settings Using this option completely erases all settings including language which may have been set by the supervisor Restore Defaults Yes Cancel To restore factory defaults 1 Access the Supervisor Menu Select Restore Defaults to display the Restore Defaults Menu 2 The Yes box will be highlighted To restore defaults press Enter 3 To not restore defaults press Next to highlight Cancel Press Enter to return to the Supervisor Menu Table 1 Factory default settings Parameter Default setting Volume 3 Password 123 CPR Timer 120 Language English US First energy protocol 200 Second energy protocol 300 Third energy protocol 360 Self test counter 0 ECG Counter 0 LOG setup SmartLink CPR tempo 100 Shock counter 0 Total energy 0 Shocks delivered 0 Elapsed time 0 Shock mode 1 shock CPR User Manual Programming 55 Setting the Unit ID The supervisor has the ability to assign a specific Unit ID number to the Welch Allyn AED 10 The AED 10 includes this ID number when reporting events so that it can be correctly identified among other AEDs The Unit ID and the department name can be sent to the SmartLink application when transferred by the user through the IR port see Transmitting the internal log via the infrared data port on page 36
68. ly contain actions They follow the procedural steps to which they refer In this manual notes are displayed as shown in the following example Note The default supervisor password is 1 2 3 Voice prompts The Welch Allyn AED 10 provides audio instructions through the built in speaker to provide operating instruction and assist the user during defibrillation In this manual voice prompts are displayed as shown in the following example e Low battery General cautions and notices Damaged If the device has been damaged in any way refer the device to qualified service personnel for servicing Labels Observe all CAUTION and WARNING labels on the equipment and accessories Performance The Welch Allyn AED 10 may not meet performance specifications if stored transported or used outside the specified storage or operating environmental range limits Notices U S Federal law restricts this device to be used by or on the order of a physician If the battery pack is removed for any reason the user must label the Welch Allyn AED 10 as Out of service due to battery operation User Manual Safety 3 Patient safety General A AN Shock hazard A Burns WARNING Accessory adapter required for use on pediatric patients The AED 10 is not to be used on patients less than 8 years old or under 25kg 55 Ibs unless it is equipped with the accessory AED 10 Pediatric Energy Reducer Welch Allyn part number 0021 73 U WARNING Ferromagne
69. nsecutive shocks During the CPR cycle the Welch Allyn AED 10 will suspend patient heart rhythm analysis promoting a complete and uninterrupted cycle of CPR 3 Shock Analyze Like the 3 shock CPR mode the AED 10 will deliver one shock followed by an immediate analysis of the patient s heart rhythm while in a shockable event The AED 10 will also continue to analyze the heart rhythm and determine whether additional shocks are indicated The CPR cycle begins after a No Shock Advised prompt or after delivering the third shock However during the CPR cycle the Welch Allyn AED 10 will continue to analyze the patient heart rhythm Should the Welch Allyn AED 10 detect the presence of a shockable rhythm during the CPR cycle the user will be prompted to stop CPR The AED 10 will analyze patient heart rhythm and if need prompt the user to deliver a shock A No Shock Advised text prompt will continue to flash on the display accompanied by an audible tone every minute until a shockable rhythm is detected User Manual Using the defibrillator 35 Post use procedures Working with the internal log After each use the Welch Allyn AED 10 internal log can be downloaded to a PC via the infrared data port Reports can be generated with one of two Welch Allyn communication kits SmartLink Lite software and SmartLink Event Pro software The SmartLink Lite communication kit can be used to produce a hardcopy report from your desktop
70. nvironmental conditions patterns of use and age the Welch Allyn AED 10 batteries will eventually begin to indicate a low battery condition Activities such as frequently turning on the device or leaving the device idle for an extended amount of time will decrease the life of the battery and accelerate the timeframe for indicating a low battery warning Other problems Indicator Possible Cause A fault requires service AED 10 operates but LCD is blank Operating temperature is too low or too high LCD not operating properly AED 10 always powers up with menu displayed Corrective Action Continue to use the AED 10 if it is possible and needed Contact authorized service personnel as soon as possible to repair the AED 10 Operate the AED 10 between 0 and 50 C 32 and 122 F Contact authorized service personnel Stuck lower menu button Contact authorized service personnel 72 Troubleshooting Welch Allyn AED 10 Automated External Defibrillator Frequently Asked Questions Will the Welch Allyn AED 10 function correctly if have reversed the placement of the defibrillation pads when placed them on the patient s chest Yes The Welch Allyn AED 10 s ability to analyze the rhythm and to deliver shocks is independent of the polarity of the defibrillation pads See Apply defibrillation pads to the patient s bare chest and connect cable on page 29 Do select the energy level with successive shocks No The ener
71. ompts and read text instructions on the screen next to the large number 2 e First apply pads to patient s bare chest e Then connect the cable to the AED 10 3 If prompted press the red Shock button next to the large number 3 Begin CPR Start with chest compressions User Manual Using the defibrillator 29 Operating procedures Detailed information The Quick Reference operating procedure in the preceding subsection provides the main steps for operating the Welch Allyn AED 10 1 Assess the Patient Start the Welch Allyn AED 10 Apply Defibrillation Pads to the Patient s Bare Chest and Connect Cable 2 3 4 Analyze the Patient s Heart Rhythm 5 Deliver the Shock if prompted press the red button 6 Perform CPR For each step detailed operating information or procedures follow Assess the patient Before using the Welch Allyn AED 10 assess the patient s condition Use the unit only if all of the following patient signs are present e Unconsciousness e Absence of breathing e Unresponsiveness no signs of circulation Start the Welch Allyn AED 10 Push the green ON OFF button next to the large number 1 to power on the Welch Allyn AED 10 ON OFF button Apply defibrillation pads to the patient s bare chest and connect cable For defibrillation to be effective it is important to correctly place the pads on the patient and connect the defibrillation p
72. oooooooca RIT 56 Utility MEI 3 paaa I ori rr reg m e es eR rr Bead pe 57 40 Programming Welch Allyn AED 10 Automated External Defibrillator Menu structure diagram Main Menu Soft keys for Next User selectable menu selection options Ente Menu structure overview The operating options are available to the operator through a simple menu structure The basic system operating options are accessed through the Main Menu The advanced system operating options are accessed through the Supervisor Menu Accessing the Main Menu from startup To access the Main Menu hold down the lower Enter soft key and press the power button to turn on the defibrillator A menu similar to the above diagram will appear on the left side of the LCD display Although unlabeled on the front panel decal of the AED 10 the display will turn on and identify the keys while in menu mode To exit shut off power Use the Next soft key on the left side of the LCD display to move from one menu selection to the next The selected menu item is highlighted by a dark box Press the Enter button to select the highlighted menu item Main Menu Nox Enter User Manual Programming 41 Main Menu selections Volume Adjust the volume level Contrast Adjust the LCD contrast Date Display the current date set and save the date month day year Time Display the current time set and save the time hour minute Log Allows the user to 1 Clear the existing
73. or Fantastik ether benzene ammonia cleaner Windex or Coverage 66 Maintenance Welch Allyn AED 10 Automated External Defibrillator Table 2 Cleaning instructions and cleaning solutions Equipment Cleaning Instructions Welch Allyn AED 102 e Wipe with a nearly dry cloth moistened with cleaning solution e Thoroughly wipe off any excess cleaning solution Do not let cleaning solution run into connector openings or crevices Accessories e Consult manufacturer s instructions Approved Cleaning Solutions Warm water liquid soap Ovation hydrogen peroxide solution Wex cide T B Q 9 Formula 4099 Consult manufacturer s instructions a Theequipment can be disinfected to comply with OHSA requirements for cleaning and decontaminating spills of blood and other body fluids Federal OHSA Standard on blood borne pathogens 29 CFR 1910 1030 12 6 91 b If liquid gets into the connectors dry the area with warm air and then verify proper functions c Wex cide Wexford Labs Inc Kirkwood MO and T B O Calgon Vestal Lab Calgon Corp St Louis MO are disinfectants that meet OSHA requirements are EPA approved and will not harm the outside of the defibrillator Wipe away disinfectants with a water dampened cloth after the manufacturer s recommended period User Manual Maintenance 67 Recycling defibrillator components Within the European Union pd Do not dispose of this product as unsorted municipal w
74. or storage temperatures e g hot or cold environments near to or outside the specified operating limits 0 to 50 C affect the life of the battery Battery capacity may also be diminished by other environmental extremes such as high humidity gt 95 moisture IPX4 and altitude extremes lt 150 to gt 4750 m User Manual Introduction 15 Installing the battery The Welch Allyn AED 10 uses an extended life lithium manganese dioxide non rechargeable battery To install the battery 1 2 Open the battery compartment located near the bottom of the back of the AED 10 by removing the black rubber feet and then sliding the battery cover back and off 3 Locate the three battery contact pins in the bottom right corner of the battery compartment Push the 3 pin battery connector firmly onto the contact pins The connector can be installed in either direction 16 Introduction Welch Allyn AED 10 Automated External Defibrillator bdo 4 Place the battery into the battery compartment and replace the battery cover Slide the cover on so that the screw holes are aligned 5 Replace the black rubber feet 6 Cycle power on by using the On Off button 7 Make sure the system status indicator see page 21 in the center of the AED 10 indicates that the battery has sufficient charge If the system status indicator displays anything other than the Battery Ready icon the Welch Allyn AED 10 is not ready for u
75. quency RF interference Do not operate the Welch Allyn AED 10 in conjunction with electrocautery or diathermy equipment Any equipment that emits strong radio frequency signals can cause electrical interference and distort the ECG signal to cause inaccurate interpretation of rhythm User Manual Safety 5 Defibrillator and electrode pads Explosion WARNING Explosion hazard Possible explosion hazard if used in the presence of concentrated oxygen or flammable anesthetics Electrical shock or fire hazard A WARNING No internal operator serviceable parts Do not open unit remove covers or attempt to repair the Welch Allyn AED 10 All servicing must be performed by qualified personnel WARNING Improper use can cause injury The Welch Allyn AED 10 contains an automatic disarm of the stored energy If the operator has not delivered the energy to a patient or a test load an internal timer will disarm the stored energy This stored electrical energy can potentially cause death or injury if discharged improperly Follow all instructions in this users manual A Caution Do not immerse or expose the Welch Allyn AED 10 to water or other liquids Do not use the defibrillator if unit has been immersed in liquid or if excessive condensation is visible on the device Caution Conductive parts should not contact other conductive parts including the earth 6 Safety Welch Allyn AED 10 Automated External Defibrillator Improper device perform
76. r 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Power frequency 3 A m 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact x 8 kV ai Not app Not app Not app Not app Not app Not app Not app Not app 10 A m r icable icable icable icable icable icable icable icable Note Uy is the ac mains voltage prior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment User Manual Specifications 79 Guidance and manufacturer s declaration electromagnetic immunity IEC 60601 1 2 Table 203 The Welch Allyn AED 10 is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn AED 10 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Welch Allyn AED 10 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF 10 V m 10 V m d 1 20 P IEC 61000 4 3 80 MHz to 2 5
77. re 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 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 Q resistor placed in series with each subject 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 is shown below Also shown are the mean total durations measured for each device Summary Table ED50 ID50 and Duration Mem WelchAlyn 2kVBiphasic AED 10 Waveform 1D50 Peak Current Amps 5 8 7 4 Significance of difference p value lt 0 001 ED50 Delivered Energy Joules 34 3 32 0 Significance of difference p value 0 885 Total Duration msec 21 3 15 6 86 Specifications Welch Allyn AED 10 Automated External Defibrillator 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 curr
78. roup 1 The Welch Allyn AED 10 uses RF energy only for Na its internal function Therefore its RF emissions RF emissions CSPR 11 Class B are very low and are not likely to cause any Harmonic Emission IEC 6100 3 2 Not applicable interference in nearby electronic equipment Voltage fluctuations Not applicable flicker emissions IEC 61000 3 3 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document 18 Specifications Welch Allyn AED 10 Automated External Defibrillator Guidance and manufacturer s declaration electromagnetic immunity IEC 60601 1 2 Table 202 The Welch Allyn AED 10 is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn AED 10 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge 6 kV contact ESD IEC 61000 4 2 8 kV air Electrical fast transient 2 kV for power supply burst lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV differential mode IEC 61000 4 5 2 kV common mode Voltage dips short 596 Uy gt 95 dip in Ur interruptions and for 0 5 cycle voltage variations on power supply input lines 40 Ur 60 dip in Ur for IEC 61000 4 11 cycles 70 Uy 30 dip in Uy fo
79. se See Troubleshooting on page 69 System status indicator Running a self test After installing the battery the Welch Allyn AED 10 automatically powers up and performs a self test At power up the following tests are performed battery main processor memory and program stuck key ECG acquisition system and defibrillator User Manual Introduction 17 Getting to know the Welch Allyn AED 10 Functions The Welch Allyn AED 10 is an automated external defibrillation AED device It features a straightforward three step operating design that uses extensive voice and visual prompts to assist the operator With continuous ECG and event recording the Welch Allyn AED 10 maintains a detailed log that can be reported directly to a computer or printer This describes the following Welch Allyn AED 10 features e Controls e Display e Text prompts e Voice prompts e cons e System status indicator e Infrared data port e Event documentation M Speaker Defibrillation pads connector System status indicator Menu selection soft keys On off button Shock button Infrared data port Display 18 Introduction Welch Allyn AED 10 Automated External Defibrillator Controls The Welch Allyn AED 10 is designed for ease of operation The operator performs this simple three step process 1 Turn the power ON 2 Follow text and voice prompts e First apply pads to patient s
80. service or upgrades Contact and technical support Please contact Welch Allyn page ii if you have any questions regarding this notice User Manual Preface vii Indemnification against defects Welch Allyn Automated External Defibrillators AED 10 US customers Welch Allyn Protocol Inc Welch Allyn provides the following indemnity to persons or legal entities that originally purchase or lease a Welch Allyn AED from Welch Allyn or an authorized distributor appointed by Welch Allyn the Purchaser Welch Allyn will at its cost defend indemnify and hold harmless the Purchaser from third party claims or legal actions for liability or damages resulting from bodily injury or death caused by a mechanical or electrical failure of the Purchaser s Welch Allyn AED or the malfunction of the Purchaser s Welch Allyn AED due to a defect in its design or manufacture This indemnity does not extend to or cover any claim or legal action for liability or damages in connection with the use of the Purchaser s Welch Allyn AED to the extent caused by 1 negligent operation of the Welch Allyn AED or failure to follow the sequential operating instructions for use of the Welch Allyn AED or 2 failures or malfunctions of the Welch Allyn AED that are due to improper maintenance including without limitation malfunctions of pads or batteries that occur after expiration of their shelf life or malfunctions of repairs replacement parts pads or batter
81. shock advised N The Welch Allyn AED 10 will direct the operator to perform cardiopulmonary resuscitation CPR to effectively resuscitate the patient e Begin CPR N Perform cardiopulmonary resuscitation CPR in accordance with the procedures and techniques presented in your CPR training In the 3 shock mode configurations the Welch Allyn AED 10 can be configured to suspend the heart rhythm analysis during the CPR interval 3 Shock CPR or provide a background heart rhythm analysis during CPR 3 Shock Analyze 34 Using the defibrillator Welch Allyn AED 10 Automated External Defibrillator Shock mode The Welch Allyn AED 10 can be configured in one of three rescue modes 1 Shock CPR Factory preset During a shockable event the AED 10 will deliver one shock followed by a cycle of CPR A CPR cycle will begin immediately after the delivery of a defibrillation shock or after a non shockable event During the CPR cycle the Welch Allyn AED 10 will suspend patient heart rhythm analysis promoting an uninterrupted cycle of CPR 3 Shock CPR Traditional three shock sequence During a shockable event the AED 10 will deliver one shock followed by an immediate analysis of the patient s heart rhythm After delivering a shock the Welch Allyn AED 10 continues to analyze the heart rhythm and determines whether additional shocks are indicated The CPR cycle begins after a No Shock Advised prompt or after delivering three co
82. t e The data suggests that the MRL Orbital Biphasic waveform in the Welch Allyn AED 10 is at least as effective as and may be more effective than either of the two tested monophasic waveforms appearing to allow termination of fibrillation episodes using lower energies e The MRL Orbital Biphasic waveform in the Welch Allyn AED 10 is as effective as the 2kV biphasic truncated exponential waveform in another commercially available defibrillator e The MRL Orbital Biphasic waveform in the Welch Allyn AED 10 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 87 B Glossary AED automated external defibrillator AHA American Heart Association ALS advanced life support arrhythmia irregular rhythm of the heart muscle BLS basic life support bradycardia abnormally slow heart rate cardiac arrest cessation of the heart muscle CPR cardiopulmonary resuscitation defibrillation high energy pulse of electricity shock delivered to the heart muscle to restore normal cardiac activity defibrillation protocol preset order and level of the shock energy delivered at defibrillation for example 200 200 360 Joules or 200 300 360 Joules ECG electrocardiogram electrocardiogram curve traced by an electrocardiograph electrocardiograph instrument used to record electrical curr
83. ted press Enter until Save is highlighted 3 Press Enter again while in the Save box to save the new Dept name 4 Toexit the Dept name prompt without changing it press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu Note There are 12 available characters for the Department name Setting the bit rate The supervisor can change the bits per second at which infrared port of the AED 10 communicates 1 While in the Supervisor Menu press the Next soft key to highlight Bit Rate and then press the Enter soft key to go the Bit Rate Menu 2 Press the Next soft key to change the bit rate to the appropriate number After the appropriate number appears press the Enter soft key 3 Press the Enter soft key to save the new bit rate 4 To exit the Bit Rate menu without changing the bit rate press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu User Manual Programming 57 Utility Menu The Utility menu allows access to the System Test function When selected the System Test will speak all the voice phrases for the selected language Utility 1 Access the Supervisor Menu screen Select Utility to display the Utility Menu 2 Press the System Test key 3 At the completion of all the voice phrases press the Next key to select Back box Leave the Utility menu by pressing the Enter key
84. the Welch Allyn AED 10 or attempt to sterilize the Welch Allyn AED 10 or any of its accessories Defibrillation pads WARNING Follow manufacturer s instructions for use of defibrillation pads Improper use of defibrillation pads may cause the Welch Allyn AED 10 to function improperly or may cause skin burns Do not use expired dry pads Do not reuse disposable pads Only use Welch Allyn approved defibrillation pads or pad adapters Caution Properly store and use defibrillation pads Store defibrillation pads in a cool dry location between 60 and 95 F or 15 and 35 C Do not sterilize the pads immerse or clean the pads with alcohol or solvents User Manual Safety 9 Safety symbols Graphical symbols letter symbols and signs listed below may be found on the Welch Allyn AED 10 and accessories Note the use of these symbols for safe and proper use of the equipment For a list of icons that display operating status information see System status indicator on page 21 i Consult accompanying documents AR Consult accompanying documents o Defibrillator protected type BF patient Earth ground A connection E Dangerous voltage Negative input terminal 4 Altitude limit Positive input terminal n y Fragile Non ionizing electromagnetic radiation t2 A Stacking limit by number Humidity limit St n 7 AMA E a lt Keep away from rain Temperature limits LiMn0 Lithium Manganese Dioxide battery This way up
85. the infrared port Reset the Welch Allyn AED 10 options to factory defaults Set the Welch Allyn AED 10 s Unit ID Set the Welch Allyn AED 10 s Department Name Set supervisor password numbers Allows the user to change the bit rate of the infrared port Opens the Utility Menu 50 Programming Welch Allyn AED 10 Automated External Defibrillator Setting the CPR timer The CPR timer begins if a No Shock Advised decision is made to time the appropriate length that CPR should be performed CPR Timer CPR Timer CPR Timer EI To set the CPR timer 1 Access the Supervisor Menu screen Highlight CPR and press Enter Select CPR Timer to display the CPR Timer Menu 2 Press the Next soft key to scroll through CPR timer lengths 3 Highlight Save by pressing Enter after the desired time has been selected Press the Enter soft key again to confirm the change and return to the CPR Menu 4 Toleave the time as it was originally press Next when the Save box is highlighted to select the Cancel box Press the Enter soft key to return to the CPR Menu Note Available CPR timer values are 15 30 60 90 120 default 150 and 180 seconds Setting the CPR tempo The CPR Tempo is the rate at which a tone plays when the CPR Timer is running CPR Tempo CPR Tempo CPR Tempo To set the CPR tempo 1 Access the Supervisor Menu screen Highlight CPR and press Enter Select CPR Tempo to display the CPR Tempo Menu 2 Press the
86. tic Equipment ECG electrodes and cables contain ferromagnetic materials They must not be used in the presence of large magnetic fields created by magnetic resonance imaging MRI equipment The large magnetic fields generated by an MRI device could move ferromagnetic equipment with an extremely violent force that could cause serious personal injury or death to persons between the equipment and the MRI device Caution Patient Physical Harm Place the Welch Allyn AED 10 in a position where it cannot harm the patient should it fall Do not use adjacent to or stacked with other equipment Keep all cables and connectors away from the patient s neck WARNING Defibrillation current can cause injury Do not touch the patient during defibrillation Do not touch equipment connected to or metal objects in contact with the patient during defibrillation Disconnect other electrical equipment from the patient before defibrillating WARNING Properly place defibrillation pads Do not allow defibrillation pads to touch each other or to touch other ECG electrodes lead wires dressings transdermal patches etc Such contact can cause patient skin burns during defibrillation and may divert defibrillating current away from the heart Remove excessive body hair which may cause skin burns or ineffective energy transfer Do not use alcohol iodine or other skin preparations These can dry the skin and may cause the AED 10 to function improperly or may cause
87. tor located to the left of the device green power button is ina ready to use state solid black icon If the status indicator is flashing a red circle with a slash through it this indicates a Low Battery situation A Low Battery condition does not render the unit inoperable but does indicate that the battery is beginning to weaken Continue to use the defibrillator if connected to a patient but replace the battery at the first opportunity before using it on another patient If a solid red circle with slash symbol appears turn on the defibrillator and note the self test results 14 Introduction Best practices Welch Allyn AED 10 Automated External Defibrillator If the unit powers on and indicates a Self Test Failure immediately remove the defibrillator from service and contact Welch Allyn If the Welch Allyn AED 10 will not power on replace the battery as it may be drained Again attempt to power on the defibrillator If the defibrillator successfully powers on and a Self Test Failure is indicated or if the defibrillator will still not power on immediately remove the defibrillator from service and immediately contact Welch Allyn Follow these recommendations to ensure readiness and lengthen use of an AED battery before a Low Battery indication 1 Rely solely on the device s status indicator to identify the operational readiness of the device rather than powering up the device Only
88. tor Possible Cause Corrective Action Defibrillator pad removed Electrical interference or radio transmissions Electrical radio frequency interference Defibrillation pads disconnected from patient or AED 10 Patient movement Patient s motion CPR seizures etc Transportation of the patient during vehicle motion No shock delivered Indicator Possible Cause Press defibrillation pad to firmly attach it to patient s skin If needed replace the pad Remove possible sources of electrical or radio interference Move hand held communication devices or other suspected devices away from the AED 10 Check the connection to the AED 10 Move patient to stable location when possible Stop patient motion if possible Stop patient movement or if possible stop vehicle transportation during analysis Corrective Action Defibrillation pad connector not properly connected to the Welch Allyn AED 10 socket Improper pad placement or pads touching each other Pads cable or connector damaged Poor defibrillation pad contact with patient s bare chest Shock button not pressed within fixed time limit Defibrillation pads disconnected from patient or AED 10 Push pads connector firmly into Welch Allyn AED 10 connector socket Check pad placement Use the pictures on the pads to make sure they are in correct location Replace pads Press pads firmly to patient s bare chest Wipe moisture from chest and or s
89. ttery Type Backlit Monochrome LCD Size 2 1 x 1 42 54 x 36 mm Resolution 160 x 100 Backlight LED Type Non rechargeable LiMnO 12V 2 6 Ah Capacity 60 discharges at 360 Joules to reach low battery warning 90 discharges typical at 360 Joules to completely exhaust the battery or 125 discharges at 200 Joules or 150 discharges at 150 Joules or 5 hours ECG monitoring Shelf Life 10 years 5 years storage 5 years standby 25 C 15 C 5 years standby after installation a Capacity of discharges tested per EN 60601 2 4 2003 Clause 101 4 with the AED protocol set according to EN60601 2 4 2003 Clause 102 3 2 Note Depending on environmental conditions patterns of use and age the Welch Allyn AED 10 batteries will eventually begin to indicate a low battery condition Activities such as frequently turning on the device or leaving the device idle for an extended amount of time will decrease the life of the battery and accelerate the timeframe for indicating a low battery warning User Manual Specifications 71 Electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic emissions IEC 60601 1 2 Table 201 The Welch Allyn AED 10 is intended for use in the electromagnetic environment specified below The customer or the user of the Welch Allyn AED 10 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 G
90. us injection of 20 mg kg sodium pentothal They were then intubated with a cuffed endotracheal tube and maintained on isoflurane gaseous anesthetic The femoral artery 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 5096 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 84 Specifications Welch Allyn AED 10 Automated External Defibrillator Results episodes Three ED50 estimation procedures were run in parallel with the device being used alternated on each shock After
91. use in either in hospital or out of hospital arrests It is intended that the operator is authorized by a physician medical director and has the following training skills e American Heart Association Heartsaver course American Red Cross CPR AED course NSC CPR and Rescuer Course or equivalent e Training in the use of the Welch Allyn AED 10 Fibrillation and defibrillation Ordinarily the heart produces regular electrical activity normal sinus rhythm NSR Fibrillation is an abnormal heart rhythm that replaces the normal rhythmic contraction of the heart During fibrillation irregular cardiac electrical activity causes rapid uncoordinated twitching movements As a result the heart cannot pump blood effectively causing a lack of appropriate circulation and pulse Defibrillation is the delivery of a brief high energy pulse of electricity to the heart muscle using a device called a defibrillator Early defibrillation increases the potential to restore the normal cardiac electrical activity and allow the heart s natural pacemaker areas to regain normal function The Welch Allyn AED 10 using direct current applies a brief high energy pulse of electricity to the heart to counteract fibrillation of the heart muscle and restore a normal heartbeat The Welch Allyn AED 10 will only administer a defibrillation pulse to a patient exhibiting a shockable cardiac rhythm Shockable rhythms are described in Rhythm recognition performance on pag
92. with the Back box highlighted 58 Programming Welch Allyn AED 10 Automated External Defibrillator 59 5 Maintenance This section contains information on inspecting maintaining cleaning and servicing the Welch Allyn AED 10 Inspection in E cc ee le 60 Automatic selt to MA MB Ok ce eee eee A 60 Inspecting for damages ERE a eee n EE 61 Service and repair WERE O oo ee eee eee Y 61 Maintenance schedule 2 0 00 eee 62 General Wye Bk LN Mese m RR e A a o 62 Checklists for preparedness 2 0 een 63 Operator s checklist csse I AS 64 Inspecting and cleaning the Welch Allyn AED 10 0 00 0002 o 65 Recycling defibrillator components s anaana eea 67 Within the European Union 2 0 aaa aaa aM 67 Outside the European Uni 67 60 Maintenance Welch Allyn AED 10 Automated External Defibrillator Inspection To ensure the readiness and optimum working condition of the Welch Allyn AED 10 the unit should be inspected weekly or monthly depending on the frequency of its use The checks outlined in the operator checklists should be planned according to the inspection schedule outlined below Frequency of Use Inspection Schedule Monthly Weekly Infrequently such as once a year Monthly Also new pads or other accessories should be checked for compatibility with the Welch Allyn AED 10 when they are first received Note If the Welch Allyn AED 10 is used more than once per
93. y is activated and it can be used on a patient in this condition or continued in use when connected to a patient if the low battery indicator activates Replace the battery as soon as possible Note f the AED 10 is subjected to cold temperatures near or outside of its low temperature operating limit of 32 F 0 C the low battery status indicator may be triggered even with a new battery The low battery indicator caused by cold temperature may cease when the device is warmed Discharging the device to defibrillate a patient may cause sufficient warming to eliminate the low battery indicator or cause it to be intermittent User Manual Maintenance 63 Checklists for preparedness Use FDA Checklist and Automated External Defibrillators Operator s Checklist to help maintain the Welch Allyn AED 10 in an operation ready condition An important part of a successful maintenance program is the creation of a maintenance log in which information is recorded on a regular basis The log provides a e Record of the maintenance performed who performed it and when it was completed e Schedule of periodic requirements such as calibration and certification e Tracking of accessories such as batteries that require periodic testing and replacement 64 Maintenance Welch Allyn AED 10 Automated External Defibrillator Operator s checklist In accordance with the recommendations of the Defibrillator Working Group of the Food and Drug Administration

User Manual, AED10 Automatic External Defibrillator

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