Related Manuals for Welch Allyn AED 10
Summary of Contents for Welch Allyn AED 10
- Page 1 Welch Allyn AED 10 Manual Get an original copy of the Welch Allyn AED 10 Operators Guide for manufacturer information about service, available accessories and how to use and maintain your device.
- Page 2 AED 10 Automatic External Defibrillator User Manual Software version 2.06.XX...
- Page 3 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.
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Page 4: Table Of Contents
Overview ............10 Getting the Welch Allyn AED 10 Ready ....... 11 Getting to Know the Welch Allyn AED 10 . - Page 5 Contents Welch Allyn AED 10 Automatic External Defibrillator Recycling Defibrillator Components ........59 6 - Troubleshooting .
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Page 6: Preface
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:... -
Page 7: Contact And Technical Support
US Customers Welch Allyn Protocol, Inc. (Welch Allyn) provides the following indemnity to persons or legal entities that originally purchase or lease a Welch Allyn AED from Welch Allyn or an authorized distributor appointed by Welch Allyn (the Purchaser). Welch Allyn will, at its cost, defend, indemnify, and hold harmless the Purchaser from... - Page 8 User Manual Preface 2. providing to Welch Allyn and its counsel all other evidence relevant to the Claim, whether in the form of documents or testimony. Welch Allyn will promptly notify the Purchaser in writing if Welch Allyn determines that the Claim is not covered by this indemnity, and Welch Allyn shall have the unrestricted authority to defend or settle any Claims for which indemnification is required by this agreement.
- Page 9 Preface Welch Allyn AED 10 Automatic External Defibrillator...
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Page 10: Safety
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. -
Page 11: General Cautions And Notices
U.S. Federal law restricts this device to be used by or on the order of a physician. If the battery pack is removed for any reason, the user must label the Welch Allyn AED 10 as “Out of service due to battery operation. ”... -
Page 12: Patient Safety
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). - Page 13 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...
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Page 14: Defibrillator And Electrode Pads
Follow all instructions in this users manual. 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. -
Page 15: Battery Care
“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. -
Page 16: Safety Symbols
Graphical symbols, letter symbols, and signs listed below may be found on the Welch Allyn AED 10 and accessories. Note the use of these symbols for safe and proper use of the equipment. For a list of icons that display operating status information, see “System... - Page 17 Safety Welch Allyn AED 10 Automatic External Defibrillator...
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Page 18: Introduction
Introduction This chapter provides an introduction to the Welch Allyn AED 10 system and presents an overview of the Welch Allyn AED 10 controls, indicators, displays, and prompts. It also provides instructions for getting the Welch Allyn AED 10 ready for use and preparing the unit for storage. -
Page 19: Overview
Continuous surveillance of battery level Qualified Operators The Welch Allyn AED 10 permits trained users to administer a brief electrical shock to patients experiencing fibrillation or sudden cardiac arrest (SCA). A qualified operator is someone who has successfully completed a CPR AED training course (e.g., AHA Heartsaver course or equivalent course provided by an accredited... -
Page 20: Getting The Welch Allyn Aed 10 Ready
2. Plug in the 3-pin connector. 1. Remove the battery cover. Open 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. 2. Locate the 3 battery contact pins in the bottom-right corner of the battery compartment 3. -
Page 21: Getting To Know The Welch Allyn Aed 10
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”... -
Page 22: Controls
Controls 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: Turn the power ON. -
Page 23: Display
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... -
Page 24: Text Prompts
Voice Prompts 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. -
Page 25: Battery Level Indicator
Introduction Welch Allyn AED 10 Automatic External Defibrillator Stand clear Defibrillator charged and ready to shock; do not touch or move patient Stop CPR Stop CPR, wait for further instructions It is safe to touch the Defibrillator shock has been delivered... -
Page 26: System Status Indicator
User Manual Introduction 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 AED10 Ready Battery is properly installed, charged, and system is ready for use. -
Page 27: Infrared Data Port
Welch Allyn AED 10. The AED 10 IR communication kit with Smartlink Lite Software (002143) or AED 10 Communication Kit with Smartlink... -
Page 28: Preparing The Welch Allyn Aed 10 For Storage
Store a new set of defibrillation pads in the carrying case electrode storage pocket – located on the inside flap of the AED 10 carrying case. Spare pads can be stored in the exterior pocket of the carrying case. Make sure the pad expiration date can be viewed through the pad window of the carrying case. -
Page 29: Parts List
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... -
Page 30: Using The Defibrillator
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. -
Page 31: Overview
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. -
Page 32: Indications And Contraindications For Use
• Unconsciousness • Absence of breathing • Unresponsiveness (no signs of circulation) Contraindications The Welch Allyn AED 10 should NOT be used if the patient exhibits any of the following signs: • Patient is conscious • Patient is breathing •... -
Page 33: Operating Procedures - Quick Reference
2. Connect the cable to the AED 10. Start the Welch Allyn AED 10 and Deliver a Shock Push the green ON/OFF button located at the upper right corner of the Welch Allyn AED 10 next to the large number “1” . -
Page 34: Operating Procedures - Detailed Information
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: •... -
Page 35: Start The Welch Allyn Aed 10
(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... -
Page 36: Deliver Shock
All other rhythms are determined “non-shockable” and therefore the patient is not a candidate for defibrillation. If it is not a shockable condition, the Welch Allyn AED 10 alerts the user with text and voice. “No shock advised. ”... - Page 37 Welch Allyn AED 10 Automatic External Defibrillator Shock button AED10 The Welch Allyn AED 10 does not allow the operator to charge or discharge the Note defibrillator unless a shockable rhythm is detected. After delivering a shock, the Welch Allyn AED 10 prompts for immediate CPR.
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Page 38: Defibrillator Disarm
User Manual Using the Defibrillator Defibrillator Disarm If the defibrillator is charged and the Shock button is not pressed, the Welch Allyn AED 10 must be disarmed. • The defibrillator discharges automatically in 30 seconds. After 25 seconds, a warning tone indicates that the defibrillator will disarm automatically. -
Page 39: Shock Mode
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"... -
Page 40: Post-Use Procedures
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. -
Page 41: Transmitting The Internal Log Via The Infrared Data Port
Keep the infrared data port and adapter cable roughly 6 to 10 inches apart. Note 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”... -
Page 42: Storing The Welch Allyn Aed 10 For Reuse
Using the Defibrillator 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. - Page 43 Using the Defibrillator Welch Allyn AED 10 Automatic External Defibrillator...
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Page 44: Programming
........48 Programming the AED 10 . -
Page 45: Menu Structure Diagram
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. -
Page 46: Main Menu Selections
User Manual Programming Main Menu Selections Volume Adjust the volume level. Contrast Adjust the LCD contrast. Date Display the current date; set and save the date (month, day, year). Time Display the current time; set and save the time (hour, minute). Allows the user to: Clear the existing event log, or 2. -
Page 47: Adjusting The Volume
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. -
Page 48: Adjusting The Contrast
Programming 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. -
Page 49: Setting The Time
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. -
Page 50: Transmitting Or Clearing The Internal Log
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”... -
Page 51: Setting Up The Internal Log
Welch Allyn AED 10 Automatic External Defibrillator Setting Up the Internal Log The Welch Allyn AED 10 has two modes of transmitting the internal log to a PC. Both methods utilize the infrared data port located on the front of the unit. To select which method to use, the user must access the Log: Setup Menu. -
Page 52: Supervisor Menu
User Manual Programming Supervisor Menu Supervisor Menu Structure Overview Supervisor CPR Timer CPR Timer Language CPR Tempo 15/30/60/90/120/ 150/180 Protocol Back Save Shock Mode Cancel Program Language More CPR Tempo Energy Language Back Save 90/95/100/105/110/ 150/200 Main Menu 115/120/Disable Cancel 150/200/300 Save 150/200/300/360... -
Page 53: Accessing The Supervisor Menu
Back 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. -
Page 54: Setting The Cpr Timer
User Manual Programming Program Allows the user to update to the current version of Welch 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. -
Page 55: Selecting A Language (Software Revision 2.0 Or Later)
4. To leave the language as it was originally, press Next when the Save box is highlighted to select the Cancel box. Press the Enter soft key to return to the Supervisor Menu. Note Changing the language will cause the AED 10 to reboot into automated mode. -
Page 56: Setting The Energy Protocol
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). -
Page 57: Changing The Supervisor Password
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. -
Page 58: Programming The Aed 10
Due 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. -
Page 59: 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”... -
Page 60: Setting The Department Name
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. 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. - Page 61 Programming Welch Allyn AED 10 Automatic External Defibrillator Access the Supervisor Menu screen. Select Utility to display the Utility Menu. 2. Press the System Test key. 3. At the completion of all the voice phrases, press the Next key to select Back box.
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Page 62: Maintenance
..........57 Cleaning and Disinfecting the Welch Allyn AED 10 . -
Page 63: Inspection
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. -
Page 64: Inspecting For Damage
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 power-up the Welch Allyn AED 10 and automatically perform a self-test. -
Page 65: Maintenance Schedule
Maintain the Welch Allyn AED 10 as described in this manual. General Prepare a customized maintenance schedule for the Welch Allyn AED 10 to reflect how the unit will be used. The schedule should account for how often the unit is used and where it is used. -
Page 66: Operator's Checklist
User Manual Maintenance 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. -
Page 67: Cleaning And Disinfecting The Welch Allyn Aed 10
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. -
Page 68: Recycling Defibrillator Components
(Labeling of batteries and accumulators containing certain dangerous substances). Outside the European Union 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. - Page 69 Maintenance Welch Allyn AED 10 Automatic External Defibrillator...
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Page 70: Troubleshooting
..........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. -
Page 71: Analyzing Interrupted
No Shock Delivered Indicator/Possible Cause Corrective Action Electrode pad connector not properly connected to the Push pads connector firmly into Welch Allyn AED 10 Welch Allyn AED 10 socket. connector socket. Improper pad placement or pads touching each other. Check pad placement. Use the pictures on the pads to make sure they are in correct location. -
Page 72: Defibrillator
Indicator/Possible Cause Corrective Action A fault requires service. 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. AED 10 operates, but LCD is blank. -
Page 73: Frequently Asked Questions
Will the Welch Allyn AED 10 function correctly if I 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... -
Page 74: A - Specifications
Specifications Physical ............. . 66 Electrical Isolation . -
Page 75: Physical
Specifications Welch Allyn AED 10 Automatic External Defibrillator Physical Dimensions 8 1/4" x 6 7/8" x 2 3/4" (210 x 175 x 70 mm) Weight 3.5 (1.6 kg) pounds with battery Operating Temperature 32ºF to 122ºF (0ºC to 50ºC) Storage Temperature -22ºF to 158ºF (-30ºC to 70ºC) -
Page 76: Defibrillator
Waveform Details 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 Ω. The waveforms are characterized by typical values for peak... -
Page 77: Pediatric Energy Reducer
Specifications Welch Allyn AED 10 Automatic External Defibrillator Pediatric Energy Reducer 25%, at 25 Ω, 50 Ω and 75 Ω Energy Attenuation Factor 20%, at 100 Ω and 125 Ω 15%, at 150 Ω and 175 Ω Display Type Backlit Monochrome LCD Size 2.1”... -
Page 78: Electromagnetic Compatibility
(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. - Page 79 (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.
- Page 80 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.
- Page 81 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...
- Page 82 Specifications Rhythm Recognition Performance Standards The Welch Allyn AED 10 algorithm exceeds the requirements of ANSI/AAMI DF39-1993 section 3.3.18 and the sensitivity and specificity levels recommended by the AHA 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 (>...
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Page 83: Summary Of Studies Of Waveform Safety & Effectiveness
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. - Page 84 The mean ED50 peak current for the biphasic waveform was 39 percent of that required with the MDS waveform. Summary Table - ED50 & ID50 Mean Welch Allyn Monophasic AED 10 Damped Sine ID50 Peak Current (Amps) 16.6 Significance of difference (p-value) <0.001 ED50 Delivered Energy (Joules) 26.3...
- Page 85 Specifications Welch Allyn AED 10 Automatic External Defibrillator episodes). Three ED50 estimation procedures were run in parallel, with the device being used alternated on each shock. After each of the three independent ED50 estimation procedures had been completed, the entire protocol was repeated twice more, each time starting all devices at an energy of 30 joules.
- Page 86 Also shown are the mean total durations measured for each device. Summary Table -ED50, ID50, & Duration Mean Welch Allyn 2kV Biphasic AED 10 Waveform ID50 Peak Current (Amps) Significance of difference (p-value) <0.001 ED50 Delivered Energy (Joules) 34.3...
- Page 87 • 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. •...
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Page 88: B - Glossary
Glossary automated external defibrillator American Heart Association advanced life support arrhythmia irregular rhythm of the heart muscle basic life support bradycardia abnormally slow heart rate cardiac arrest cessation of the heart muscle 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... - Page 89 ECG samples and time-stamped system events nonshockable rhythm patient heart rhythms that are not a candidate for defibrillation pulse normal sinus rhythm Primary AED AED 10 mode that provides text and voice prompts protocol see defibrillation protocol radio frequency sudden cardiac arrest self-test...