1 year

Has electrical safety

Visual inspection – Check that inscriptions, information and warning signs are properly and completely
fixed.

Visual inspection – Check for mechanical damage to the device.

Visual inspection – Perform inspection of battery compartment and battery connection for corrosion and
other contamination.

Functional inspection – Perform the Faultless self-test (see “Self-test”).

Functional inspection – Check front panel dials, keys, and displays.

Functional inspection – Perform inspection of all connections and cables.

Functional inspection – Perform examination of warnings.

Rate test – (10 mA; 3.0 mV; 30 ppm) Verify that the pulse-to-pulse interval is within the specified
tolerance. 1800 – 2200 ms

Rate test – (10 mA; 3.0 mV; 70 ppm) Verify that the pulse-to-pulse interval is within the specified
tolerance. 771 – 943 ms

Rate test – (10 mA; 3.0 mV; 180 ppm) Verify that the pulse-to-pulse interval is within the specified
tolerance. 300 – 367 ms

Rapid atrial pacing – Check that the output rate is 320 ppm +/- 10%. (169 – 206 ms)

Rapid atrial pacing – Check that the rapid atrial pacing is available over the range of 80 – 800 ppm +/-
10% using the INCREASE/DECREASE keys.

Pulse width – Verify that the pulse width is 1.8 ms +/- 10% (1.62 – 1.98 ms) as measured from the half
-amplitude point on the leading edge to the half amplitude point on the trailing edge.

Output – (0.1 mA) Verify that the measured outputs are within specified tolerances. 0 – 0.11 V

Output – (5.0 mA) Verify that the measured outputs are within specified tolerances. 2.08 – 2.92 V

Output – (20.0 mA) Verify that the measured outputs are within specified tolerances. 8.45 – 11.55 V

Sensitivity – (0.5 mV) Verify that the threshold falls within the range specified for each setting. 0.2 – 0.8
mV

Sensitivity – (5 mV) Verify that the threshold falls within the range specified for each setting. 3.75 –
6.25 mV

Sensitivity – (20 mV) Verify that the threshold falls within the range specified for each setting. 15.0 –
25.0 mV

Frequency response – Check that the generator output is 3 mV.

Frequency response – (100 ms (10 Hz)) Verify the sensitivity, keeping in mind any percent error to be
added from the initial 3 mV measurement. 201.0 mV +/- 20%.

Frequency response – (40 ms (25 Hz)) Verify the sensitivity, keeping in mind any percent error to be
added from the initial 3 mV measurement. 3 mV (reference).

Frequency response – (5 ms (200 Hz)) Verify the sensitivity, keeping in mind any percent error to be
added from the initial 3 mV measurement. 46.5 mV +/- 25%.

Refractory period – Check that the signal generator amplitude is 200 mV. The 10:1 attenuator on the
output of the generator will reduce this to a 20 mV pulse at the pacemaker.

Refractory period – (input the squarewave with a 235 ms delay) Verify that the pacing rate remains at 80
ppm (750 ms).

Refractory period – (input the squarewave with a 265 ms delay) Verify that the pace-to-pace interval is
increased to approximately 1015 ms.

AC (50 Hz) – Check that the interference rejection is 2.0 mVp-p noise while sensing 3.0 mV, 40 ms sine-
squared test pulses.