A-A-54368
Recorder. The recorder shall have the following characteristics:
a. Frequency response shall conform at a minimum to the specifications given for the cardioscope display.
b. Shall have a paper speed of 25 mm/second. Paper speed shall be accurate to within plus or minus 5 percent.
c. ECG paper shall have a minimum grid width of 40mm and contain at least 50 feet per roll.
d. A low paper indication shall be provided, either by the instrument or in the form of a mark on the paper.
e. The recorder must be an integral part of the monitor section of the defibrillator/monitor instrument and not a stand-alone instrument requiring electrical cabling inter-connection to provide patient data.
Defibrillator. The defibrillator shall have the following characteristics:
a. The defibrillator performance requirements shall be in conformance with American National Standard for Cardiac Defibrillator Devices, ANSI/AAMI DF2, unless otherwise specified.
b. The defibrillator pulse shape shall be a clinically proven one such as a Lown, Edmark or Trapezoidal, as defined in MI DF2.
c. The maximum selectable delivered energy of the defibrillator shall lie in the range 320 to 400 joules (J) inclusive. The defibrillator shall provide a selection of at least six energy outputs within the range of 5 J to maximum energy when delivered into a 50 ohm resistive load. At least three (3) of these outputs shall be less than 110 joules.
d. The delivered pulse energy shall be within 4 J or plus or minus 15 percent of the selected energy on the energy level indicator, whichever is greater, when discharged into a 50 ohm resistive load.
e. The defibrillator shall be capable of delivering 10 pulses with maximum energies into a 50 ohm resistive load within 5 minutes, at 32°F.
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