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DAC-510E-EN-BG

8.1.5.1 Shockable Rhythm Criteria

When placed on a patient meeting the indications for use criteria, the

DDU-100

AED is designed to

recommend a defibrillation shock when it detects proper pad impedance and one of the following:

Ventricular Fibrillation

Peak-to-peak amplitude at least 200 µVolts.



Warning

Some very low amplitude or low frequency VF rhythms

may not be interpreted as shockable.

Ventricular Tachycardia

(including ventricular flutter and

polymorphic VT)

Cardiac rhythm rate of at least 180 bpm and peak-to-peak amplitude at

least 200 µVolts.



Warning

Some very low amplitude or low frequency VT rhythms

may not be interpreted as shockable.

The

DDU-100

AED is designed to recommend

shock for all other rhythms, including Normal

Sinus Rhythms, fine Ventricular Fibrillation (<200 µVolts), and some slow Ventricular Tachycardias
and Asystole.

Содержание Lifeline DCF-100

Страница 1: ...DAC 510E EN BG Defibtech DDU 100 Semi Automatic External Defibrillator User Manual AHA ERC 2010 ELECTRONIC DISTRIBUTION www AmericanAED com...

Страница 2: ......

Страница 3: ...iii DAC 510E EN BG...

Страница 4: ...tion refer to the Contacts section of this manual Tracking U S A federal regulations require Defibtech to maintain records for each AED it distributes reference 21 CFR 821 Medical Device Tracking Thes...

Страница 5: ...Maintenance 7 2 2 Improper Device Performance 7 2 2 1 Usage Environment 7 2 2 2 Pads 8 2 2 3 Patient Analysis 8 2 2 4 Shock Delivery 9 2 2 5 Maintenance 9 2 3 General 10 3 Setting up the DDU 100 AED 1...

Страница 6: ...ive Status Indicator 30 5 2 2 Checking the Condition of the Unit and Accessories 31 5 2 3 Running a Manually Initiated Self Test 32 5 2 4 Replacing Pads 32 5 2 5 Checking Pad and Battery Pack Expirati...

Страница 7: ...teria 50 8 1 5 2 Patient Analysis System Performance 51 8 1 6 Clinical Summary 51 8 1 6 1 Background 51 8 1 6 2 Methods 52 8 1 6 3 Results 52 8 1 6 4 Conclusion 52 8 1 7 Guidance and Manufacturer s De...

Страница 8: ...viii DAC 510E EN BG...

Страница 9: ...he AED detects a shockable rhythm Prompts the operator to press the SHOCK button when the device is ready and a shock is recommended Delivers a shock once the device has determined a shock is required...

Страница 10: ...and audio audio enabled cards only if sufficient space is available on the card Audio recording is available only for units with installed audio enabled Defibtech Data Cards Event documentation stored...

Страница 11: ...to indicate the unit is fully operational and blinks red to indicate unit needs attention from the user or servicing L Patient pads The defibrillation monitoring pads that are placed on the patient T...

Страница 12: ...indications The DDU 100 AED should not be used if the patient shows any of the following signs Conscious and or responsive Breathing Has a detectable pulse 1 5 OperatorTraining Requirements In order t...

Страница 13: ...t in serious personal injury or death CAUTION Conditions hazards or unsafe practices that may result in minor personal injury damage to the DDU 100 AED or loss of data 2 1 Shock Fire Hazard Explosion...

Страница 14: ...ndard In compliance with IEC classification the DDU 100 AED is not to be used in the presence of flammable substance air mixtures CAUTION Do not immerse any portion of this product in water or other f...

Страница 15: ...and metal objects which may provide unwanted pathways for defibrillating current 2 1 5 Maintenance WARNING Electrical shock hazard Dangerous high voltages and currents are present Do not open unit re...

Страница 16: ...ient Analysis WARNING Aggressive or prolonged CPR to a patient with defibrillation pads attached can cause damage to the pads Replace the defibrillation pads if they become damaged during use WARNING...

Страница 17: ...patient skin burns To help prevent air pockets make sure self adhesive defibrillation pads completely adhere to the skin Do not use dried out or expired defibrillation pads 2 2 5 Maintenance WARNING...

Страница 18: ...10 DAC 510E EN BG 2 3 General CAUTION Federal law USA restricts this device to sale by or on the order of a physician...

Страница 19: ...are required to begin using the device 3 1 Overview The following components and accessories are included with your DDU 100 AED Replacement and other accessories are detailed in the DDU 100 AED Acces...

Страница 20: ...Active Status Indicator 9V Battery A user replaceable lithium 9V battery located inside the battery pack provides Active Status Indicator ASI power This auxiliary battery is used to provide standby in...

Страница 21: ...nstall the battery pack after the expiration date printed on the label The battery pack is non rechargeable A green Active Status Indicator on the label side of the battery pack will blink periodicall...

Страница 22: ...ng should be opened only immediately prior to use otherwise the pads may dry out and become non functional Note The DDU 100 AED is designed to be stored with the pads connector already installed This...

Страница 23: ...om The user should refer to the Troubleshooting section in Chapter 5 of this manual for appropriate action Note Every time the manually initiated Self Test is run the unit does an internal shock test...

Страница 24: ...16 DAC 510E EN BG...

Страница 25: ...and prompts guide the operator through the use of the unit The following sections describe in detail how to use the DDU 100 AED The basic steps for use are Turn the DDU 100 AED ON by pressing the ON...

Страница 26: ...tive Status Indicator Off Battery pack not installed AED is defective or the 9V battery is discharged Install functional battery pack or replace the 9V battery in the battery pack Steady On green The...

Страница 27: ...ackage Pull the protective backing from the pads and check that the pads are Free from obvious signs of damage Clean of excessive debris for example dirt if the pad was dropped Not dried out and that...

Страница 28: ...he dotted line near the top of the package Remove the pads from the package and follow the directions and diagram showing proper defibrillation pad placement located on the defibrillation pad package...

Страница 29: ...patient s bare chest as shown This indicates that the DDU 100 AED has determined that the pads are not placed on the patient Place pads on the patient following instructions on the pad package If the...

Страница 30: ...erference related voice prompts Stop motion This indicates that the DDU 100 AED has detected motion in the patient Stop all patient motion including CPR in response to this message If the patient is b...

Страница 31: ...ised This indicates that the DDU 100 AED has determined that a shock is not required The unit will not charge and the SHOCK button will not be enabled The user will be prompted to begin CPR if needed...

Страница 32: ...r a shock The operator should press the SHOCK button to deliver the shock The Shock button will flash during this phase SHOCK Off No Shock indicated Button is disabled pressing the button will do noth...

Страница 33: ...te to perform CPR If needed begin CPR This indicates that the user should begin CPR if needed for two minutes The unit will not be monitoring the patient s ECG rhythm during this two minute CPR period...

Страница 34: ...conds or Continue for 1 minute x seconds This indicates that the user should continue performing CPR for x more seconds or for 1 minute and x more seconds respectively The unit will not be monitoring...

Страница 35: ...asses Connect a new pad package check to make sure the package is not expired Hold ON OFF button down for at least five seconds to initiate a manually initiated Self Test Unit will report status of th...

Страница 36: ...28 DAC 510E EN BG...

Страница 37: ...nd no voltage will be present at the pads at any time Note Every time the manually initiated Self Test is run the unit does an internal shock test This test reduces the capacity of the battery pack by...

Страница 38: ...elf test should be performed 5 2 1 Checking Active Status Indicator The Active Status Indicator ASI is located in the upper corner of the DDU 100 AED and indicates the operational readiness state of t...

Страница 39: ...eplaced soon The AED will still be able to deliver at least a minimum of three defibrillation shocks the first time this message is spoken Replace battery pack This indicates that the battery pack is...

Страница 40: ...the ON OFF button again If the Self Test fails The user should refer to the Troubleshooting section in Chapter 5 of this manual 5 2 4 Replacing Pads The Defibtech defibrillation monitoring pads are in...

Страница 41: ...an accessory is past its expiration date it should be replaced immediately Follow the instructions in the Installing and Removing the Battery Pack and Connecting the Pads sections to replace the part...

Страница 42: ...of the 9V battery compartment Replace the 9V battery compartment door by reversing the process used to remove the door If the battery pack is stored out of the AED for an extended period of time remo...

Страница 43: ...cket Soapy water Ammonia based cleaners Hydrogen peroxide Isopropyl alcohol 70 percent solution Chlorine bleach 30 ml liter water Ensure that the connector socket is completely dry before reinstalling...

Страница 44: ...rator s Checklist Defibtech DDU 100 Serial Number ___________________________________________________ Defibtech DDU 100 Location __________________________________________________________ Date Check u...

Страница 45: ...rode pads are not pre connected to unit Connect electrode pads to unit ASI does not blink at all ASI 9V battery depleted Replace ASI 9V battery Battery pack not inserted Insert battery pack Battery pa...

Страница 46: ...as been detected Stop external interference Analyzing interrupted voice prompt Motion or interference detected Stop motion or interference Shock cancelled voice prompt Patient s ECG rhythm changed No...

Страница 47: ...39 DAC 510E EN BG 5 8 Repair The DDU 100 AED contains no user serviceable parts If the unit need servicing return to an authorized service center Refer to Contacts section for contact information...

Страница 48: ...40 DAC 510E EN BG...

Страница 49: ...stored with pads connected When the DDU 100 AED is used the operator needs only to remove the pad packaging tear open the package and turn the device on to administer care The AED has a storage area i...

Страница 50: ...prevent the main defibrillation battery from being depleted for non essential functions This provides a significantly longer standby life for the AED and battery pack and extends the lifetime during...

Страница 51: ...us event will NOT be erased If the DDC fills completely the AED will still be operable and the most critical event documentation for the current session is still recorded internally Internally recorde...

Страница 52: ...tronic Equipment EEE may contain polluting components and hazardous substances the accumulation of which could pose serious risk for the environment and human health It is for this reason that local A...

Страница 53: ...tioning DefibView is a stand alone software application It cannot be used with the AED in operation and exists solely to support post event review of the data recorded on a DDC or downloaded to a DDC...

Страница 54: ...ately after each shock and all ECG data during the charging and waiting to shock periods Note Audio data is not logged internally To download the internally logged information perform the following pr...

Страница 55: ...516 5 Procedure IV 1 meter any edge corner or surface in standby mode Vibration MIL STD 810F 514 5 Category 20 RTCA DO 160D Section 8 8 2 Cat R Zone 2 Curve G Helicopter RTCA DO 160D Section 8 Cat H...

Страница 56: ...by a single SHOCK button DISARM Automatic If Patient Analysis System decides rhythm is no longer shockable or Within 30 seconds after Charge complete if operator has not pressed SHOCK button or If de...

Страница 57: ...es that the pad patient impedance is within the proper range and analyzes the patient s ECG rhythm to determine whether a shock is required On detection of a non shockable rhythm the user is prompted...

Страница 58: ...low amplitude or low frequency VF rhythms may not be interpreted as shockable VentricularTachycardia including ventricular flutter and polymorphic VT Cardiac rhythm rate of at least 180 bpm and peak...

Страница 59: ...rnal Defibrillators for Public Access Defibrillation Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporating New Waveforms and Enhancing Safety American He...

Страница 60: ...nd biphasic groups in terms of age sex weight primary structural heart diseases cause or location of arrest bystanders who witnessed the arrest or type of responder A summary of the results is present...

Страница 61: ...stablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61...

Страница 62: ...bol 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 st...

Страница 63: ...r 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 wh...

Страница 64: ...de Disposable recyclable non rechargeable ASI battery standby life after installation 1 year typical new battery at 25 C 8 2 2 Standard Lithium Battery Pack Category Specification Model number DBP 140...

Страница 65: ...urns 8 4 Defibtech Data Cards DDCs Use only Defibtech Data Cards in the DDU 100 AED Defibtech Data Cards are available as follows Standard DDCs Model Number Details DDC 6 Up to 6 hours of ECG data DDC...

Страница 66: ...on various Windows platforms including Windows 98 Windows 2000 and Windows XP Minimum system requirements for adequate performance are as follows Pentium II Processor at 300 MHz 32 Mbyte System Memory...

Страница 67: ...MS the device when it is charged and then turns the device OFF Y Y Y Y Do not expose to high heat or open flame Do not incinerate Y Y Y Y Recyclable X X X X Y Y Y Y Consult operating instructions Refe...

Страница 68: ...Y Manufacturer Y Y Y Y Date of manufacture Y Y Y Y Y Y Y Y Manufacturer and date of manufacture Y Y Y Y Do not reuse Y Y Y Y For USA users only Federal Law USA restricts this device to sale by or on...

Страница 69: ...ed by TUV Rheinland of NA with respect to electric shock fire and mechanical hazard only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 and IEC 60601 2 4 Conforms to UL Standard...

Страница 70: ...62 DAC 510E EN BG...

Страница 71: ...oston Post Road Guilford CT 06437 USA Y Y Y Y Tel 1 866 333 4241 Toll free within North America 1 203 453 4507 Fax 1 203 453 6657 Email sales defibtech com Sales reporting defibtech com Medical Device...

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Страница 73: ...IVE REMEDY At Defibtech LLC s sole discretion Defibtech shall have the option to repair replace or provide a credit In the event of replacement Defibtech shall have the right at its sole discretion to...

Страница 74: ...4 D499 183 This product and its accessories are manufactured and sold under license to at least one or more of the following United States patents 5 591 213 5 593 427 5 601 612 5 607 454 5 611 815 5 6...

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