1 year

Visual inspection – Technical Manual.

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

Visual inspection – check for mechanical damage to the device.

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

Functional inspection – faultless self-test at power-up.

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

Functional inspection – inspection of all connections and cables.

Functional inspection – examination of warnings.

Rate test (Atrial Rate) – (at 30 ppm) verify that the measured atrial pulse interval is within specified
tolerance. 27 – 33 ppm

Rate test (Atrial Rate) – (at 120 ppm) verify that the measured atrial pulse interval is within specified
tolerance. 108 – 132 ppm

Rate test (Atrial Rate) – (at 200 ppm) verify that the measured atrial pulse interval is within specified
tolerance. 180 – 220 ppm

Rate test (Ventricular Rate) – (at 30 ppm) verify that the measured ventricular pulse rate is within
specified tolerance. 27 – 33 ppm

Rate test (Ventricular Rate) – (at 120 ppm) verify that the measured ventricular pulse rate is within
specified tolerance. 108 – 132 ppm

Rate test (Ventricular Rate) – (at 200 ppm) verify that the measured ventricular pulse rate is within
specified tolerance. 180 – 220 ppm

Rapid atrial pacing test – (at 350 ppm) verify on the analyzer that the atrial rate is within the specified
tolerance. 332 – 368 ppm

Rapid atrial pacing test – (at 800 ppm) verify on the analyzer that the atrial rate is within the specified
tolerance. 760 – 840 ppm

Ventricular current output – (at 1.0 mA) verify that the measured outputs are within specified limits.
0.9 – 1.1 mA

Ventricular current output – (at 5.0 mA) verify that the measured outputs are within specified limits. 4.5
– 5.5 mA

Ventricular current output – (at 10.0 mA) verify that the measured outputs are within specified limits.
9.0 – 11.0 mA
Ventricular current output – (at 25.0 mA) verify that the measured outputs are within specified limits.
22.5 – 27.5 mA

Atrial current output – (at 1.0 mA) verify that the measured outputs are within specified limits. 0.9 –
1.1 mA

Atrial current output – (at 5.0 mA) verify that the measured outputs are within specified limits. 4.5 – 5.5
mA

Atrial current output – (at 10.0 mA) verify that the measured outputs are within specified limits. 9.0 –
11.0 mA

Atrial current output – (at 20.0 mA) verify that the measured outputs are within specified limits. 18.0 –
22.0 mA

Atrial sensitivity – (at 1.0 mV) verify the sensing threshold falls within the range specified. 0.75 – 1.25
mV

Atrial sensitivity – (at 2.0 mV) verify the sensing threshold falls within the range specified. 1.50 – 2 .50
mV

Atrial sensitivity – (at 5.0 mV) verify the sensing threshold falls within the range specified. 3.75 – 6.25
mV

Atrial sensitivity – (at 10.0 mV) verify the sensing threshold falls within the range specified. 7.5 – 12.5
mV

Ventricular sensitivity – (at 1.0 mV) verify the sensing threshold falls within the range specified. 0.75 –
1.25 mV

Ventricular sensitivity – (at 3.0 mV) verify the sensing threshold falls within the range specified. 2.25 –
3.75 mV

Ventricular sensitivity – (at 10.0 mV) verify the sensing threshold falls within the range specified. 7.50 –
12.50 mV

Ventricular sensitivity – (at 20.0 mV) verify the sensing threshold falls within the range specified. 15.00
– 25.00 mV

Off current drain (optional) – Specification ≤ 150 μA.

On current drain (optional) – verify default settings of: rate = 80 bpm, Atrial Output = 10 mA, Ventricular
Output = 10 mA.

On current drain (optional) – verify that the DC current drawn is ≤ 3 mA.