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User Manual, AED10 Automatic External

1. 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 Toexit 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 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 52 Programming Welch Allyn AED 10 Automatic External Defibrillator 1 Access the Supervisor Menu screen Select Utility to display the Utility Menu 2 Press the System Test key 3 Atthe completion of all the voice phrases press the Next key to select Back box Leave the Utility menu by pressing the Enter key with the Back box highlighted 53 D Maintenance This section contains information on inspecting maintaining cleaning and servicing the Welch Allyn AED 10 EPSON oss dd REY RR VEA C A A aa Ye Eee Ried 54 Automato Delibes Esos costes seh E Rts GE SHY betes we eE e ca 54 Inspecting for Damage siis rues da dee a wd 55 a Repslr i xussenussk aee E aeos eu Rs eeu RR Rh PRO d 55 Maintenance Schedule eere 56 A TP 56 Checkli
2. 2 Listen to voice prompts and read text instructions on the screen next to the large number 2 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 25 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 2 Attach the Electrodes and Connect the Cable 3 Start the Welch Allyn AED 10 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 Attach the Electrode Pads and Connect the Cable For defibrillation to be effective it is important to correctly place the pads on the patient and connect the electrodes 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 Note To remove pads pull the wire upward from the device Note
3. 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 User Manual Programming 51 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 oua 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 selected 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
4. 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 58 Maintenance Welch Allyn AED 10 Automatic External Defibrillator Cleaning and Disinfecting the Welch Allyn AED 10 Clean and disinfect the Welch Allyn AED 10 regularly and observe the following cleaning and disinfecting guidelines A Clean the unit with the battery in place to keep liquids out of the battery contact area Make sure liquid does not get into the electrode pads connector Use a soft cloth Do not use abrasive materials cleaners or strong solvents such as acetone or acetone based cleaners Caution Do not immerse any portion of the Welch Allyn AED 10 in water or other liquids Avoid spilling any liquids on the Welch Allyn AED 10 or its accessories Liquids may damage the unit or present a fire or shock hazard Caution Do not autoclave or gas sterilize the Welch Allyn AED 10 or accessories The following are recommended cleaning agents for use on the exterior of the Welch Allyn AED 10 Fantastik Formula 409 Hydrogen peroxide solution INCIDIN9 Liquid soap T B Q Warm water Wexcide Windex Never use any of the fo
5. LED Non rechargeable LiMn02 12V 2 6 Ah 90 discharges at 360 Joules or 125 discharges at 200 Joules or 150 discharges at 150 Joules or 5 hours ECG monitoring 10 years 5 years storage 5 years standby 5 years standby after installation Battery capacity measured according to IEC 60601 1 2 4 claf use 102 3 2 at room temperature Capacity may be diminished by extremes or when the available battery charge is used in multiple power ON OFF cycles User Manual Electromagnetic Compatibility Specifications 69 Category Standard Level Radiated Emissions EN55011 CISPR11 B ESD EN61000 4 2 8kV air 6kV contact Radiated Susceptibility EN61000 4 3 10 V m 20 V m EN 60601 2 4 Magnetic Field Emissions MIL STD RE101 AAMI DF2 4 3 18 1 Magnetic Field Susceptibility MIL STD RS101 1 Gauss 47 Hz 1 8 kHz 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 Electromagnetic environment guidance Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CSPR 11 Class B Harmonic Emission IEC 6100 3 2 Not applicable Voltage fluctuations Not applicable flicker emissions IEC 61000 3 3 The Welch Allyn AED 10 uses RF energy only for its internal function Therefo
6. 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 The table below 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 Q The waveforms are characterized by typical values for peak current Ip duration of the first output phase and duration of the second output phase Values are within 10 lQ Rd bee 0 ndis n Tues md 25 522 357 5 6 3 8 50 26 5 16 9 11 6 7 75 17 5 11 8 16 6 9 9 100 13 3 9 3 18 8 9 9 125 10 5 1 7 19 9 10 3 150 8 9 6 8 20 2 10 3 175 7 5 6 0 20 4 10 3 Output Energy Accuracy 10 or 1 J whichever is greater into 50 Q impedance 15 or 1 J whichever is greater into any impedance from 25 Q to 125 Q Typical transthoracic impedance with properly applied Welch Allyn defibrillation pads is under 125 Q 68 Specifications Welch Allyn AED 10 Automatic External Defibrillator Pediatric Energy Reducer Display Battery Energy Attenuation Factor Type Size Resolution Freq Response Low Battery Indicator Backlight Type Capacity Shelf Life 25 C 15 C 25 at 25 Q 50 Q and 75 Q 20 at 100 Q and 125 Q 15 at 150 Q and 175 Q Backlit Monochrome LCD 2 1 x 1 42 54 x 36 mm 160 x 100 1 to 40 Hz Battery Icon gauge on display with 10 capacity levels
7. info card energy reducer acquired separately 001853 Welch Allyn Multipurpose Defibrillation Pads One Pair 001855 Welch Allyn Multipurpose Defibrillation Pads 10 pair 980150 Welch Allyn AED 10 Trainer with IR Remote Control Training Pads and Carrying Case 001857 Pre Attached Defibrillation Pads 1 pouch 2 pads Pads sealed in pouch with cable exposed 001858 Pre Attached Defibrillation Pads 1 box 10 pair Pads sealed in pouch with cable exposed 002173 AED 10 Pediatric Energy Reducer 002168 carrying For use with AED 10 devices only pouch and instructions for use 002137 Welch Allyn First Responder AED Prep Kit 002143 SmartLink Lite AED 10 IR Communications Kit 002169 SmartLink Event Pro AED 10 IR Communications Kit Additional supplies and accessories are available for your device Contract your local Welch Allyn representative or authorized distributor for more information 21 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 Ro RDUM 22 Tamed Lee A cs Ladder EI e RERUM e EAM Deer texas 22 Fibrillation and Defibrillation llle 22 Indications and Contraindications for Use 23 Operating Pro
8. 1 a teh fut ees Ata ew tae 6 Electrodes xu etes RR we DUM E eR Ee ER x e IE EAS 6 Satety SvEDBOIS dq Eus da GE Ter ae pe Luke eeu ie en des pi Loic R youd 7 2 5 POO UCHION a ds hi te cto Eu Ad d Ment ese s 9 ONVer VIeW iut it es DL Rae N o Deed Se E Oeo TP Last 10 Getting the Welch Allyn AED 10 Ready 000 000 cece ees 11 Getting to Know the Welch Allyn AED 10 0 0 0000 ee eee 12 Preparing the Welch Allyn AED 10 for Storage 19 Part Eds cito a ete da Bit da queria rin do ig Dh eas landi shade gl Ao i A A ga 20 3 Using the Defibrillator ix es rr Aa 21 AA A II UN EL Mnt AS 22 Operating Procedures Quick Reference 24 Operating Procedures Detailed Information a anaana naa 25 FPost Use Procedures nu dto Paris e feris MU R e ea doas i te Pe c et 31 4 Programming sese eiii ANE RE ERE 35 Menu Structure Diagram llis 36 Menu Structure Overview o 36 Accessing the Main Menu from Startup liliis 36 S pebvISOL GD s Suse dul ce ise eus Lo ae Lee ML Ld Ru ET 43 B lt WiaintenanCes 2 sedg tb o e e RERO Us ih M d M ent cnc 53 E zoo pad eor E eec ed eiui qued ast een A 54 Maintenance Schedules rato es torear tarea tante eser ie gana 56 Cleaning and Disinfecting the Welch Allyn AED 10 58 iv Contents Welch Allyn AED 10 Automatic External Defibrillator Recycling Defibrillator Components 59 6 Troubleshooting xxr a Re erg eed ee 61 OVOLVIGW cum oberen E s ate LA REOR ADR Ud eds Uu ate art
9. 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 electrode pads to improve adherence to patient s skin Troubleshooting Analyzing Interrupted Welch Allyn AED 10 Automatic External Defibrillator Indicator Possible Cause Corrective Action Defibrillator pad removed Electrical interference or radio transmissions Electrical radio frequency interference Electrode disconnected from patient or AED 10 Patient movement Patient s motion CPR seizures etc Transportation of the patient during vehicle motion Press electrode 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 No Shock Delivered Indicator Possible Cause Corrective Action Electrode pad connector not properly connected to the Welch Allyn AED 10 socket Improper pad placement or pads touching each other Pads cable or connector
10. 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 service or upgrades Contact and Technical Support Please contact Welch Allyn page ii if you have any questions regarding this notice 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 tts 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 Welc
11. Allyn AED 10 Automatic External Defibrillator 35 4 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 Daerenn 000 esce e Sek A eg x ame ea signees dos Res tc be 36 Menu Structure Overveens eaaa ma ue Avge oe taa pada Ra oe nd wae R E E Aa 36 Accessing the Main Menu from Startup ae eee ae 36 Main Menu Selections n n annna anaana aaaea 37 Main Menu Structure Overview 37 Adjusting the Volume eee 38 Adjusting the Contrast ux Duce ec EU x aU Re E Gd Ye eut 39 belt the Dale coord ep Ebo tee Sgen tea sS Erste teo d 39 PSR INS TIME 22 nui sete DERBI ESO a ia OE SEA S 40 Transmitting or Clearing the Internal Log s ro e ee e a cc ees 41 Setting Up the Internal Log 42 Supervisor MiS aci ia ad aboot td ida dt ta donde at ad tado ed 43 Supervisor Menu Structure Overview llle res 43 Accessing the Supervisor Menu 0 eee eee 44 Supervisor Menu Items o 44 Setting the CPR TIMET ule iati oe ne a da 45 Setting the CPR Temp teirri ye bade eee ae eae Pea eee C RR 45 Selecting a Language Software Revision 2 0 or later o o oooo o o 46 Seti the Energy PROIDEUl soi w er dao ade eens we SEI 47 betung the Shock Mode io eye renns axe Waa ee Rer Ae 47 Changing the Supervisor Password 0000 00 ccc cena 48 Programming me AE
12. DO NOT REUSE PADS A WARNING Excessive body hair may affect the operation of the electrodes or cause skin burns on the patient Remove body hair as needed to ensure that the electrode pads make proper contact with the patient s chest To attach electrodes and connect the cable 1 Open the package containing the defibrillation pads and cable 2 Peel off the backing from the electrode pad labeled RA Place this pad just below the patient s right collarbone sternum as illustrated on the AED 10 pad placement illustration 26 Using the Defibrillator Welch Allyn AED 10 Automatic External Defibrillator 3 Peel off the backing from the electrode 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 IT 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 Apply pads to patient s bare chest and connect the cable Start the Welch Allyn AED 10 Push the green ON OFF button next to the large number 1 to poweron the Welch Allyn AED 10 ON OFF button User Manual Using the Defibrillator 21 Analyze the Patient s Heart Rhythm When the pads are properly applied and co
13. 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 of the unit is operating Check the status indicator Verify that the Inspect exterior of Welch Allyn AED 10 and pad connector for any signs of damage Make sure that all supplies and accessories are present and in proper operating condition Inspect the defibrillation pad packages and battery packs for install before dates and any signs of damage After each use Check battery ready to use status indicator on the front If the status indicator is flashing replace the battery If a solid red symbol appears turn on the AED 10 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 will not power on replace the battery as it is probably drained Clean the Welch Allyn AED 10 If damaged remove AED 10 from service and contact Welch Allyn customer service Do not use damaged or expired supplies or accessories Replace any used supplies and accessories such as razors gloves and pads Check the battery capacity shown in the battery gauge on the display If Low B
14. 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 23 Indications and Contraindications for Use Once the Welch Allyn AED 10 is connected via the defibrillation electrode 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 02173 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 Prior to using the Welch Allyn AED 10 the patient should be assesse
15. and after a rest period VF was again induced The energy was now increased about 2096 for the next defibrillation attempt This procedure was continued until approximately 4 reversals in result were observed with each waveform Two ED50 estimation procedures were run in parallel with the device being used alternated 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 O 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 amp Duration Mean Welch Allyn 2kV Biphasic AED 10 Waveform ID50 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 18 Specifications Welch Allyn AED 10 Automatic External Defibrillator Conclusion The MRL Orbital Biphasic waveform was as effective a
16. 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 Icons e System Status Indicator e Infrared Data Port e Event Documentation User Manual Controls Introduction 13 speaker defibrillation pads connector system status indicator menu selection soft keys shock button WelchAltyn infrared data port display AED10 ay The Welch Allyn AED 10 is designed for ease of operation After putting the defibrillator pads on the patient and connecting them to the Welch Allyn AED 10 unit the operator performs this simple three step process E M 1 Turn the power ON 2 Follow text and voice prompts 3 If prompted deliver shock by pressing the flashing red Shock button 1 power on 2 text and 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 14 Introduction Display Welch Allyn AED 10 Automatic External Defibrillator Text prom
17. 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 Appendix A All other rhythms are determined non shockable and the patient is not
18. damaged Poor defibrillation pad contact with patient s bare chest Shock button not pressed within fixed time limit Electrode 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 shave 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 63 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 displ
19. 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 What is the capacity of the battery Refer to Battery Level Indicator on page 16 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 battery level status indicator alerts you when the battery needs to be replaced 65 Specifications ps CCCII 66 Electrical Isolation s io cessas dariak sa adeli a a a ka i a aa RR es 66 Data Managemen AU o d ee nia E a ER er e ERR e ES 66 DefibnllStor a CR RR mun 67 Pediatric Energy Bed cer isis eoa e oon p GO Or Vy ER REG 68 BUS CXII aves Sea oa ee 68 DAME da A A AA AAA GREER AR Se ERA 68 Electromagnetic Compatibility iiis less esee e ke Re he 69 Summary Of Studies Of Waveform Safety amp Effectiveness llli sies 7A 66 Specifications Physical Dimensions Weight Operating Temperature Storage Temperature without battery Humidity Altitude Shock Vibration Water resistance Drop Test Electrical Isolation Power External Electrical Connections Risk Current Category Data Management Event Documentation Inte
20. in minor personal injury or damage to the equipment In this manual cautions are displayed as shown in the following example AN Caution Conditions hazards or unsafe practices that can result in minor personal injury damage to the Welch Allyn AED 10 or loss of data Notes Notes contain information that augments or clarifies an operating step Notes do not normally contain actions They follow the procedural steps to which they refer In this manual notes are displayed as shown in the following example 2 Safety Welch Allyn AED 10 Automatic External Defibrillator 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 N 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
21. 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 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 31 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 43 Supervisor Menu Supervisor Menu Structure Overview Supervisor CPR CPR Timer 150 180 Language Energy Language CPR Tempo Save 90 95 100 105 110 Main Menu 75072007300 50 200 300 Caneel 115 120 Disable Cancel Shock Mode Supervisor Menu Program 1 Shock CPR Restore Defaults 3 Shock CPR s 3 Shock Analyze Change Code Restore Defaults Unit ID Den Utility Change Code Bit Rate Current BPS Save Cancel 44 Programming Welch A
22. 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 Guidance a Specifications 1 nd 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 Conducted RF 3 Vims 3 Vims d 1 17 JP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vims 10 Vims d 1 20 JP 150 kHz to 80 MHz in ISM bands Radiated RF 10 V m 10 V m d 1 20 P IEC 61000 4 3 80 MHz to 2 5GHz 80 to 800 MHz d 2 30 JP 800 MHz to 2 5 GHz Where Pis the maximum output pow
23. summary Of Studies Of Waveform Safety amp Effectiveness Introduction Study 1 Objective Methods Over 30 years ago Medical Research Laboratories MRL patented a unique monophasic truncated exponential waveform which utilized a low peak current impedance compensated defibrillation waveform The MRL monophasic waveform was developed as an 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 dampe
24. to software upgrades or changes in functionality the Welch Allyn AED 10 may require reprogramming at some time in its service life In order to program the AED 10 the user must enter programming mode by selecting Program from the Supervisor Menu Note Programming the AED 10 should only be performed by qualified sales or service representatives Program Yes Restart in Program Mode Cancel To program the AED 10 1 Access the Supervisor Menu screen Select Program to display the Program Menu 2 Press the Enter soft key to restart the unit in program mode 3 Toleave the program as it was originally press Next when the Yes box is highlighted to select the Cancel box Press the Enter soft key to return to the Supervisor Menu Note After reprogramming the AED 10 the battery must be removed to turn off the power When the battery is reinserted the AED 10 will perform a self test and then power off 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 hig
25. 0 P d 12 10 JP d 23 10 P 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 10 3 69 3 79 3 79 7 27 100 1 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 13 Rhythm Recognition Performance Standards Performance The Welch Allyn AED 10 algorithm exceeds the requirements
26. 0 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 31 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 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 printe
27. AED 10 Automatic External Defibrillator NP W any T User Manual Software version 2 06 XX WelchAllyn Advancing Frontline Care ii Welch Allyn AED 10 Automatic External Defibrillator Copyright 2007 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 about any Welch Allyn prod
28. D VW ud ca bees adi add aoe deed dep PS 49 Restoring the Factory Default Setings eee 49 copre ME UME ID a Za Bee eee Sap EN Ephes eo wee ed 50 Setting the Department Name 51 Cet iie bu sie nadaa ra e RR hada dened I S Oe beet a ees 51 B lusc c Ur DT 51 36 Programming Welch Allyn AED 10 Automatic External Defibrillator Menu Structure Diagram Main Menu Soft keys for Next User selectable menu selection options E 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 while powering on the unit 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 Ned C Enter User Manual Programming 31 Main Menu Selections Volume Adjust the volume level Contrast Adjust the LCD contrast Date Display the cur
29. If a failure occurs during weekly self test it will be identified on the display accompanied by an audible notification Once the weekly self test failure occurs the AED 10 will turn itself on every two hours providing six audible notifications spaced 30 seconds apart Powering up the AED 10 using the ON button will reset the hourly notification If a LOW BATTERY is detected during the self test for two consecutive weeks the unit will wake itself up 30 seconds after the weekly self test executed and provide a single beep followed by the voice prompt LOW BATTERY The AED 10 will turn itself off and wake up 30 seconds later to repeat the beep and the LOW BATTERY phrase The AED 10 will then go to sleep for 18 hours before restarting the beep and voice prompt cycle listed above The cycle will repeat for approximately two weeks or until the AED 10 is powered up by the user to address the issue After two weeks the AED 10 will stop waking up to deliver the beep and LOW BATTERY notifications and will revert to the standard weekly self test process where it will only supply 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 two beep and LOW BATTERY notifications will be replaced by six dual beep cycles each 30 seconds apart These six dual beep notifications will be repeated every 18 hours for approximately two weeks or u
30. O 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 electrodes 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 defibrillation 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 ba
31. a bystander or conductive surface before pressing the Shock button Stand clear IN k Shock now Press the red button now A 2 Press Shock to deliver a shock 28 Using the Defibrillator Welch Allyn AED 10 Automatic 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 29 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 shock advised The Welch Allyn AED 10 will direct the operator to perform cardiopulmonary resuscitation CPR to effectively resuscitate the patient e Begin CPR Perform cardiopulmonary resuscitati
32. after the defibrillation studies Waveform Safety amp Effectiveness Conclusions These scientific studies have demonstrated that 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 79 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 el
33. attery 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 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 User Manual Maintenance 57 Operator s Checklist In accordance with the recommendations of the Defibrillator Working Group of the Food and Drug Administration 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 Verify date and time Cables Connectors Inspect for cracks broken wire or damage
34. ay 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 For battery recycling information see Recycling Defibrillator Components on page 59 Other Problems Indicator Possible Cause Corrective Action 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 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 64 Troubleshooting Welch Allyn AED 10 Automatic External Defibrillator Frequently Asked Questions Will the Welch Allyn AED 10 function correctly if have reversed the placement of the electrode pads when I 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 electrode pads See Attach the Electrode Pads and Connect the Cable on page 25 Do select the energy level with successive shocks No The energy level is preset when operating the Welch Allyn AED 10
35. ce 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 User Manual Results Specifications 15 The study consisted of 82 total fibrillation defibrillation episodes ID5O 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 amp ID50 Conclusion Study 2 Objective Methods Mean Welch Allyn Monophasic AED 10 Damped Sine ID50 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 us
36. cedures Quick Reference 24 Assess the 1 calc ice ta RIS Bea ae Ree ew eec Yu d ae ed 24 a CCEPIT 24 Start the Welch Allyn AED 10 and Deliver a ShoCk o ooooooooooooooo 24 Begin CPR Start with Chest Compressions e R e 0 E eee 24 Operating Procedures Detailed Information een 25 Assess he Patient uoi dil esee eed wes og e per da Y Rer Ra pd 25 Attach the Electrode Pads and Connect the Cable o o o oooooo ooo o 25 Attach the Electrode Pads and Connect the Cable o ooooooo ooo 25 start the Welch Allyn AED 10 sese ccs ree e t e OX lc rn e 26 Ro 22m lll lie vu cer eec Re A RS ek ee Ss RES 27 Defibrillator DIST iiie ic ad nbd ERRARE ERR EE RID DE dr en a 29 Check the Patient s Condition and Perform CPR e KR RR KRA 29 ME EROE MEME CE EET 30 Post Use Procedures ica ke REX EA E er edens 31 Working with the Internal Log 31 Transmitting the Internal Log via the Infrared Data Port ananasa oo 32 Storing the Welch Allyn AED 10 for Reuse eee 33 22 Using the Defibrillator Welch Allyn AED 10 Automatic 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 use in either in hospital or out of hospital
37. d and sent via e mail 1 05 Pade Creu ZLE Sater OH F ZL LI Sof Test fared f ELED Pods Creed Edn Sito bod Moud de DOG Wavefcan Dte E e s Ri mN ANA AA A LALA Sd ell ACA EL EIE Ex Epp HR Ia 9 pp E 9 B SIE BIB EHS 9 SIS H HE HS GIB 79H SHS 9 29H HEET EMEN EE INN SY pN pes I f 1 Fg I i II I I 1 7 i 1 Y I FI I 32 Using the Defibrillator Welch Allyn AED 10 Automatic 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 002143 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 51 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 42 and T
38. d by a trained person See Trained Operators on page 22 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 24 Using the Defibrillator Welch Allyn AED 10 Automatic 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 25 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 Attach Electrodes 1 Apply pads to patient s bare chest 2 Connect the cable to the AED 10 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
39. d press Enter Select CPR Tempo to display the CPR Tempo Menu 2 Press the Next soft key to scroll through CPR tempo values 46 Programming Welch Allyn AED 10 Automatic External Defibrillator 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 To leave 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 Selecting a Language Software Revision 2 0 or 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 EET Reboot 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 Toleave 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 User Manual Programming 47 Setting
40. d sinusoidal waveform defibrillator A canine model n 5 71 7 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 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 devi
41. eady for use and preparing the unit for storage VEO MEY NE UU rd dM ho Se ee TOR ARE 4 eGR Sha eee oad Seen eed 10 Pe A 0 HE el raa T K Seas me ee ee ati Cae wom an eee le 10 QualiiBd OBSISPIOIS ssa daas Pada AR ORR EES e PP 10 Getting the Welch Allyn AED 10 Ready 0 0 e e e eK 11 Unpacking and Inspecting 0 00 05 cc ee aca p ada E aOR a mer mes 11 Install the Banery cssc RN A eee oe v ee 11 piacere 1 e ose ah ee hh A soe SEEM eared OOM ee GE 12 Getting to Know the Welch Allyn AED 10 xs ae e tenes 12 B 1o CREER CCP 12 COMME ti ta a a a pa Aa ls a dec dow setae 13 Disp c nde edo eit der edd eque pd Ade addidi dd 14 TEKE ae 1 REMITTI 15 Voce PEORES 2 2 554 a ub EX E YAG C ERDAUUEIS eae A GS Ed 15 Battery Level MdlgstOl uisa ese dp X pene Eo ehh qe Ron qoe deed 16 System Stats ls e coordinada DIGG Pr I 17 miara Data rep EE E PC M 18 Event Documentation nux xk ge NEZ RIReX GE ee REX EAR 18 Preparing the Welch Allyn AED 10 for Storage 0 0 eese 19 Poe Ge 12 52707 E ta oh oh te et a bas Se ata gut eatin Doble a aveo atin Ba ea 20 Wen Ai AED IU cesis estem Pade ec es OM a RR ald 20 a o csi c kk acdc piece on E dcus amp dong Medo god dedo cede dde er dedic 20 10 Introduction Welch Allyn AED 10 Automatic 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
42. ectrocardiogram electrocardiogram curve traced by an electrocardiograph electrocardiograph instrument used to record electrical currents 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 Glossary Welch Allyn AED 10 Automatic 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 powerup 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
43. ed in a study that was approved by the Institutional Animal Care and Use Committee The animals were anesthetized with an intravenous injection of 20 mg kg sodium pentothal They were then intubated with a cuffed endotracheal tube and maintained on isoflurane gaseous anesthetic The femoral 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 ED5O 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 16 Specifications Results Welch Allyn AED 10 Automatic External Defibr
44. el 1 Access the Supervisor Menu screen Select Shock Mode to display the Shock Mode Menu 48 Programming Welch Allyn AED 10 Automatic External Defibrillator 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 Zoo HH La Cancel 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 Toexit 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 User Manual Programming 49 Programming the AED 10 Due
45. em is not ready for use Battery may not be properly installed 18 Introduction Welch Allyn AED 10 Automatic External Defibrillator Infrared Data Port The built in Infrared Data Port provides a wireless connection to the Welch Allyn IRDA device See Event Documentation 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 is required to produce an event report User Manual Introduction 19 Preparing the Welch Allyn AED 10 for Storage After each use any event documentation should be retrieved from the internal log and printed Any error messages or malfunctions should be reported and corrective actions taken before storing the unit for reuse Then the Welch Allyn AED 10 should be inspected cleaned used pads should be removed and a new supply of electrode pads restocked to prepare the unit for its next use Do not open sealed pads bag until immediately prior to use Note To remove the pads pull the wire upward from the device Note DO NOT REUSE PADS Store a
46. en the battery compartment located near the bottom of the back of the AED 10 by removing the thumbscrews and then sliding the battery cover up and off Locate the 3 battery contact pins in the bottom right corner of the battery compartment Push the 3 pin battery connector onto the contact pins The connector can be installed in either direction Place the battery into the battery compartment and replace the battery cover Slide the cover back so that the screw holes are aligned 12 Introduction Welch Allyn AED 10 Automatic External Defibrillator 5 Replace the thumbscrews 6 Cycle power by using the On Off button 7 Make sure the system status indicator see page 17 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 use See Troubleshooting on page 61 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 powerup the following tests are performed battery main processor memory and program stuck key ECG acquisition system and defibrillator 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
47. er rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters mi Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Y Interference may occur in the vicinity of equipment marked with this symbol e A 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 b 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 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 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 theor
48. essories 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 17 7 Consult accompanying documents Earth ground iH G Defibrillator protected type BF patient FEM Negative input terminal A connection 4 Dangerous voltage Positive input terminal 4 Altitude limit Non ionizing electromagnetic radiation 3 A y Fragile Humidity limit n AMA Xx Stacking limit by number Temperature limits E 2 Keep away from rain This way up IS gt LiMn0O Lithium Manganese Dioxide battery X a Separate batteries from other disposables for recycling 4 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 GB with applicable U S and Canadian medical safety standards c C The CE Mark and Notified Body Registration Number signify the device has met all essential requirements 0297 of European Medical Device Directive 93 42 EEC 8 Safety Welch Allyn AED 10 Automatic External Defibrillator 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 r
49. etermines 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 Address for notification of Claims Welch 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 viii Preface Welch Allyn AED 10 Automatic External Defibrillator 1 Safety Conventions Used in the Manal as n a a K R R R R eee nae 1 General Cautions and NoOtiC8S o o ooooooooooro eee ene eee 2 Patient Saloy nn nn ee ee ee EE a EES 3 Defibrillator and Electrode Dada 5 Bate 15 DCUM 6 COR Sd SEIS oos ccs ross tae hae Bee oat REVUE Lew Belg ae ee 6 S e laa Fae BSE end A Ed x ex EG HA Gea e dde 6 Barely Sumbols ss id ebb eder AA See ee em Uo deb e edere d ed d eb eed 7 Conventions Used in the Manual Warnings Warnings alert the user to a special condition that could result in serious personal injury or death In this manual 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
50. etically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic 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 Over the frequency range 150 kHz to 80 MHz field strengths should be less than V 1 V m 72 Specifications Welch Allyn AED 10 Automatic 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 150 kHz to 80 MHzin 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 1
51. f 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 11 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 1 2 3 4 Open and carefully unpack each carton Examine the instruments and accessories for signs of damage Check the packing list to determine that all accessories have been received Contact Welch Allyn see page ii if anything looks damaged or is missing Installing the Battery The Welch Allyn AED 10 uses an extended life lithium manganese dioxide non rechargeable battery To install the battery O O 3 Insert the battery and replace the cover c S O Y 2 Plug in the 3 pin connector 1 Remove the battery cover Op
52. h 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 batteries 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 User Manual Preface vii 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 d
53. he 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 To set a new 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 40 Programming Welch Allyn AED 10 Automatic 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 co
54. her 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 skin burns 4 Safety Welch Allyn AED 10 Automatic 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 electrodes near the generator of an internal pacemaker Always apply electrodes 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 electrode may produce burns ECG Misinterpretation WARNING Properly place defibrillation pads Improperly placed pads may produce incorrect analysis and an inappropriate shock
55. hlight Cancel Press Enter to return to the Supervisor Menu Table 1 Factory default settings Parameter Default setting Volume 3 Password 123 CPR Timer 120 50 Programming Welch Allyn AED 10 Automatic External Defibrillator Table 1 Factory default settings Parameter Default setting Language English US First energy protocol 200 Second energy protocol 300 Third energy protocol 360 Self test counter 0 ECG Counter 0 LOG setup DEBUG CPR tempo 100 Shock counter 0 Total energy 0 Shocks delivered 0 Elapsed time 0 Shock mode 1 shock CPR 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 32 Unit ID Unit ID 000000000000 000123456000 Save Cancel To set Unit ID Save 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
56. illator episodes Three ED50 estimation procedures were run in parallel with the device being used alternated on each shock After each of the three independent ED5O 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 1D50 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 amp Duration Conclusion Mean Monophasic Welch Allyn 2kV Biphasic Waveform AED 10 Waveform ID50 Peak Current Amps 9 0 6 4 8 3 Significance of difference p value 0 001 0 001 Welch Allyn AED 10 Welch Allyn AED 10 vs Monophasic vs 2kV Biphasic ED50 Delivered Energy Joules 40 2 214 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 9 123 13 1 The MRL Orbital Biphasic waveform was as effective as the Biphasic 2kV waveform and more effective than the monophasic waveform Whi
57. ions 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 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 Welch Allyn Protocol Inc 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 Welch Allyn Protocol Inc e The Welch Allyn AED 10 equipment is used in accordance with the instructions for use User s Responsibility The Welch Allyn AED 10 is intended for use by personnel who are authorized by a physician medical director and who have the following training and skills vi Preface Welch Allyn AED 10 Automatic External Defibrillator e American Heart Association Heartsaver course American Red Cross CPR
58. lch Allyn AED 10 software via the infrared port Restore Defaults Reset the Welch Allyn AED 10 options to factory defaults Unit ID Set the Welch Allyn AED 10 s Unit ID Dept Set the Welch Allyn AED 10 s Department Name Change Code Set supervisor password numbers Bit Rate Allows the user to change the bit rate of the infrared port Utility Opens the Utility Menu 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 Save To set the CPR Timer Save Cancel 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 To leave 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 Save Cancel Cancel 1 Access the Supervisor Menu screen Highlight CPR an
59. le both biphasic waveforms required less peak current than the monophasic waveform the MRL Orbital Biphasic waveform required statistically less peak current than the 2 kV biphasic waveform defibrillator User Manual Study 3 Objective Methods Results Specifications 71 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 2096 for the next defibrillation attempt If the initial shock failed a rescue shock was delivered
60. llowing cleaning agents on the Welch Allyn AED 10 Acetone Ammonia cleaner Benzene Butyl alcohol Denatured ethanol Enviroquat Ether Freon Glutaraldehyde Isopropyl alcohol Chlorine bleach solution Misty Staphene Trichloroethane trichloroethylene Vesphene II User Manual Maintenance 59 Recycling Defibrillator Components Within the European Union S Do not dispose of this product as unsorted municipal waste 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 LiMnO2 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 HS 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 60 Maintenance Welch Allyn AED 10 Automatic External Defibrillator 61 Troubleshooting This chapter provides information on how to troubleshoot sit
61. llyn AED 10 Automatic External Defibrillator Accessing the Supervisor Menu The Supervisor Menu is accessed from the Main Menu Main Menu Password Password Supervisor Cancel 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 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 User Manual Programming 45 Program Allows the user to update to the current version of We
62. must label the Welch Allyn AED 10 as Out of service due to battery operation User Manual Safety 3 Patient Safety General 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 lbs unless it is equipped with the accessory AED 10 Pediatric Energy Reducer Welch Allyn part number 002168 WARNING Ferromagnetic 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 Shock Hazard 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 Burns WARNING Properly place defibrillation pads Do not allow defibrillation pads to touch each ot
63. 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 storage deployment be sure that the status indicator is visible through the round window of the carrying case 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 periodic inspection of your device should be performed on a weekly or monthly basis See Maintenance on page 53 for more information 20 Introduction Welch Allyn AED 10 Automatic External Defibrillator Parts List Welch Allyn AED 10 Partnumber Part Notes 970300 Welch Allyn AED 10 with Orbital Biphasic Waveform Includes one set of defibrillation pads battery and operator s manual AED 10 is available in a variety of deployment configurations Ask your Welch Allyn representative or authorized distributor for more information Accessories Part Number Part Notes 001852 2 Welch Allyn Battery Pack Non rechargeable LiMnO2 battery 900432 AED 10 Heart Logo Carrying Case with pad expiration Includes storage area for supplies such as date windows AED status indicator window and EMS spare pads batteries prep kit and pediatric
64. nfirm the change and return to the Main Menu 4 To leave 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 Main Menu Note Setting the time forces a new patient into the entry log User Manual Programming 4 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 31 for detailed information on Log functionality Main Menu Log Slaton vi 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 42 Programming Welch Allyn AED 10 Automatic External Defibrillator Setting Up the Internal Log The Welch Allyn AED 10 has two modes of transmitting the internal
65. nnected the Welch Allyn AED 10 announces and then automatically analyzes the patient s heart rhythm to determine if a shock is indicated 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 electrodes move e Analyzing interrupted Motion detected N 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 e No shock advised aS If a shockable condition is detected the Welch Allyn AED 10 alerts the user with text and voice e Shock advised 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 one 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
66. ntil the AED 10 is powered up by the user to address the issue If both a low battery and another fatal error are present during the self test the user will get both audible notifications described above The user can stop these notifications by powering up the unit and addressing the problem User Manual Maintenance 5 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 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 You can press the ON button to powerup the Welch Allyn AED 10 and automatically perform a self test At powerup the following tests are performed battery main processor stuck key internal circuitry ECG acquisition system and defibrillator Note Frequently powering the AED 10 on will reduce battery life Inspecting for Damage Inspect the Welch Allyn AED 10 and battery Look for signs of damage See Checklists for Preparedness on page 56 for specific inspection requirements Contact an authorized service agent immediately if e The unitis 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 Haza
67. o 001852 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 56 Caution Replace the battery at 5 years Battery replacement at 5 years is recommended due to degradation of the battery chemistry Care and Storage A Electrodes A Caution Clean and maintain the Welch Allyn AED 10 according to instructions See Maintenance on page 53 Do not clean the Welch Allyn AED 10 with alcohol ketone or any flammable agent Do not autoclave the Welch Allyn AED 10 or attempt to sterilize the Welch Allyn AED 10 or any of its accessories WARNING Follow manufacturer s instructions for use of defibrillation electrodes Improper use of defibrillation electrodes may cause the Welch Allyn AED 10 to function improperly or may cause skin burns Do not use expired dry electrodes Do not reuse disposable electrodes Only use Welch Allyn approved electrodes or electrode adapters Caution Properly store and use defibrillation pads Store electrodes in a cool dry location between 60 and 95 F or 15 and 35 C Do not sterilize the pads immerse or clean the electrodes with alcohol or solvents User Manual Safety Safety Symbols Graphical symbols letter symbols and signs listed below may be found on the Welch Allyn AED 10 and acc
68. o io oh 61 Attaching Electrode PadS esee 61 Analyzing Interrupted a reneo eee 62 No Shock Delivered anaana anaa rare 62 Defibrillator at re dp be D RR A EN 63 Battery tte duse edt as pomo ettet Lp e T Ld o S T 63 Other Problems xo aote omega a e bI ee ERE easi 63 Frequently Asked Questions reis eed seb harded Madey ode ed 64 o sso 3a ttt palsies KEI OU UE 65 PHYSICAL vest sov ets A eats Se gate Vt ee o de Rd 66 Electrical Sola i o a e R RR S oO RICE Rt ret 66 Data Management 66 DeftibrillatOr xa texte a alaa A E rl etas hoe aono de Fd Add ale as 67 Pediatric Energy Reducer naana aee 68 Display 4 iex ertet ta delet item oh ye LI Sele gas e Magee E de a ata 68 Battery moie se tact ul UU aote RA oes aa tio toc up Roe 68 Electromagnetic Compatibility esee 69 Summary Of Studies Of Waveform Safety amp EffectivenesS 74 B Gl ssaiV ia A ASE AA AS 79 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 Welch Allyn Protocol Inc Product Name Welch Allyn AED 10 and JumpStart Device Type Automated External Defibrillator Medical Device Registration Welch Allyn and its distributors are required by FDA medical device tracking regulat
69. of ANSI AAMI DF39 1993 section 3 3 18 and the sensitivity and specificity levels recommended by the AHA Automatic External Defibrillators 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 84 696 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 14 Specifications Welch Allyn AED 10 Automatic External Defibrillator
70. on 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 30 Using the Defibrillator Welch Allyn AED 10 Automatic 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 consecutive 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 1
71. 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 frequency 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 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 u
72. pts 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 Battery Shocks Time Level 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 Battery Level Displays battery status icons See descriptions below Status Displays various system status prompts such as Charging and Energy Delivered Graphical screen icons provide system operational information The 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 User Manual Text Prompts Introduction 15 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 N
73. ransmitting or Clearing the Internal Log on page 41 for more 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 33 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 electrode 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 electrode 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 53 for more information 34 Using the Defibrillator Welch
74. rdous 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 If a Welch Allyn AED 10 needs servicing contact a Welch Allyn 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 the 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 technical support for packing instructions prior to shipping This will help minimize damage during shipping Note Information such as circuit diagrams parts lists descriptions and calibration procedures needed to aid in repairing components designated as field repairable may be requested from Welch Allyn 56 Maintenance Maintenance Schedule General Caution Welch Allyn AED 10 Automatic External Defibrillator 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
75. re its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 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 70 Specifications Welch Allyn AED 10 Automatic 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 Compliance level Electromagnetic environment guidance Immunity test IEC 60601 test level 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 f 1 kV for input output lines Surge 1 kV differential mode IEC 61000 4 5 2 kV common mode Voltage dips short 596 Ur 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 5 cycles 70 Ur 30 dip in Ur for 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 8kV ai No No No No No app app app app app app app app 10 A
76. rent 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 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 rc Q Supervisor Cancel Time Cancel Password Smartlink Setup Save Cancel Clear Log Back 38 Programming Welch Allyn AED 10 Automatic 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 Cancel Log Supervisor To adjust the volume 1 Access the Main Menu Select Volume
77. rnal Memory Capacity Quick Report Communication 8 1 4 x 6 7 8 Welch Allyn AED 10 Automatic External Defibrillator x 2 3 4 210 x 175 x 70 mm 3 5 1 6 kg pounds with battery 32 F to 122 0 C to 50 C 22 F to 158 30 C to 70 C Up to 95 non condensing Up to 15 000 feet 150 to 4570 m Mil Std 810E method 516 4 procedure 1 30G 6 9ms pulse 1 2 sine each axis Mil Std 810E method 514 4 category 1 IEC 60529 IPX4 Mil Std 810F m ethod 516 5 Procedure IV 1 meter drop onto any edge corner or surface Unit operates on internal battery only No external devices are attached to the unit Internally powered equipment with defibrillator proof BF type patient applied part as per de finition 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 67 MAL Orbital Biphasic Truncated exponential Shock 1 150 J 200 J Shock 2 150 J 200 J 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
78. s the 2kV Biphasic waveform in this model of a higher impedance patient When these devices are compared on the basis of peak current the MRL Orbital Biphasic required less peak current than the 2kV Biphasic waveform Rationale for Animal Studies Electrical waveforms for transthoracic ventricular defibrillation have been well studied for nearly 50 years These studies led to the development of 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
79. sers manual T 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 Improper Device Performance WARNING Properly use electrode pads Do not attempt to warm the electrodes with a heat source greater than 35 C 95 F Do not immerse or clean electrodes with alcohol or solvents Do not perform chest compressions CPR through electrodes These actions may damage the electrode pads 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 6 Safety Battery Care A Welch Allyn AED 10 Automatic External Defibrillator Caution Do not repeatealy 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 Caution Use only Welch Allyn batteries Use only Welch Allyn Part N
80. sts for Preparedness 0 00 ee eee n e ERR ERR En 56 Operators Checklist 113 Liar asa nisa X PE a GEER OHA rx saa 57 Cleaning and Disinfecting the Welch Allyn AED 10 58 Recycling Defibrillator Components n 0 0 00 es 59 Within the European UNOM edes Sex E QR E ERE Pee or sch 59 Outside the European Union iliis 59 54 Maintenance Welch Allyn AED 10 Automatic 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 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 weekly self test the following tests are performed battery main processor stuck key internal circuitry ECG acquisition system and defibrillator
81. the Energy Protocol The Welch Allyn AED 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 Cancel Cancel 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 To leave 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 First Shock Second Shock Third Shock 150 J 150 J 150 J 200 J 200 J 200 J 300 J 300 J 360 J 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 To set Shock Mode Canc
82. 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 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 39 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 t
83. ttery No shock advised Shock advised Defibrillator pads properly attached and connected assessing heart rhythm Patient or electrode moved at unit power up Attach electrode 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 16 Introduction Stand clear Stop CPR It is safe to touch the patient Shock not delivered Battery Level Indicator rn Fully charged Welch Allyn AED 10 Automatic External Defibrillator Defibrillator charged and ready to shock do not touch or move patient Stop CPR wait for further instructions Defibrillator shock has been delivered Attempted shock did not deliver any energy to the patient Partially depleted h User Manual Introduction 17 System Status Indicator The system status indicator display located in the center of the Welch Allyn AED 10 represents the operational readiness of the battery System status indicator Ready Battery is properly installed charged and system is ready for use Use battery charge is too low for effective operation or system failure Flashing Battery is low and requires changing Do Not Syst
84. uations and conditions that arise during the operation of the Welch Allyn AED 10 and gives answers to frequently asked questions a A dus Ge angie Same each ds alte e os wh 61 Attaching Electrode Pads iiis sess sss ss ge REE a Hea ee eye rs 61 Analyzing ter upted cus cond he Rae sec d REY CERES RAO REOS A E ROSE ORE En 62 No Shock Delivered res 62 Den DESEE A hoe ita aid eh he tada hd dd 63 LA E EE 63 iher a AAA A ee OR hea Reed eee ees BOS 63 Frequently Asked QUESTIONS iiis ca anced ds bane Red ER REGE GR RE E PSY 64 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 electrode pads It is important to always have spare batteries and other accessories available Attaching Electrode Pads Indicator Possible Cause Corrective Action Electrode pad does not adhere properly to the patient Wipe moisture from chest and or shave excessive hair from chest Electrode pads are dry damaged or out of date Replace the electrode pads Improper pad placement or pads touching each other Check pad placement make sure pads are in the correct location Inadequate connection to AED
85. uct call the nearest Welch Allyn representative USA 1 800 535 6663 Australia 6129 638 3000 1 315 685 4560 800 074 793 Canada 1 800 561 8797 China 86 216 327 9631 European Call Center 353 46 906 7790 France 4 3315 569 5849 Germany 49 747 792 7186 Japan 8133 219 0071 Latin America 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 Reorder Part Number 810 2348 XX Manual Part Number 810 2356 01 Rev A 02 2007 Welch Allyn 8500 SW Creekside Place Beaverton Oregon 97008 7107 www welchallyn com Printed in USA C 0297 WelchAllyn Contents A O AN el ea ah a yeah E RO V Importante Carts e d p repo dk dest hue da e ta e e SEN V Medical Device Registration liliis ees V Manufacturer s Responsibility loli V User s Responsibility llis V Gontactand Technical Support soe ee e m eo e ied ee es vi Indemnification Against Defects vi 1 Sateby korea ERG EET EP dd Xd Eu eta a mas 1 Conventions Used in the Manual lees 1 General Cautions and Notices lise 2 Patlent Satety ees wees A ni ee Gene ie ce PUERRIGA EDI 3 Defibrillator and Electrode Pads liliis 5 Battery Care sos Fone yeas pee ade ta qe ie AS eg ier ep Gar TA 6 Care adios Ate chats wy lA es eges S
86. 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 defibrillator 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 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 brie

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