PACE 101H TECHNICAL MANUAL

TEMPORARY SINGLE CHAMBER PACEMAKER

PACE 101H TECHNICAL MANUAL TABLE OF CONTENTS

1. Function Check 4
1.1 Mechanical Inspection 4
1.2 Electrical Measurement and Inspection 4
1.2.1 Using a Pacemaker Test Equipment 4
1.2.2 Using an Oscilloscope and a Signal Generator 5

2. Safety Check 7
2.1 Micro/Macro Shock Protection Tests 7
2.1.1 Measurement of Patient Leakage Current 8
2.1.2 Insulation Test 9
2.2 Measurement of Patient Auxiliary Current 9

3. Pulse Generator Timing 10

3.1 Timing Cycle Without Intrinsic Rhythm 10
3.2 Timing Cycle with Detected R-Wave 10
3.3 Timing Cycle with R-Wave in Autoshort or Blanking 11
3.4 Timing cycle with R-wave in noise time 11
3.5 Timing cycle with R-wave in refractory time 12
3.6 Timing Cycle with R-wave After Refractory Time 12

4. Appendices 13
4.1 Stimulation Amplitude According to ISO Definition 13
4.2 Waveform of Stimulation Pulse 14
4.3 Sensitivity for sin² Test Impulses 14
4.4 Function and Safety Check with SigmaPaceTM 1000 15
4.4.1 Visual Inspection 15
4.4.2 Test Equipment & Test Set Up 15
4.4.3 Supply Current & Power Management 16
4.4.4 Patient Auxiliary Current 17
4.4.5 Pulse Amplitude2 17
4.4.6 Pulse Duration 17
4.4.7 Rate 18
4.4.8 Sensitivity3 18
4.4.9 Noise Detection 19
4.4.10 Refractory Period 19

Pace 101H Inspection Checklist 20

PACE 101H TECHNICAL MANUAL TABLE OF TABLES

Table 1: “Low Batt/Error” LED flashing and acoustic signal repetition interval depending on battery level 4
Table 2: Allowable values for leakage current 8
Table 3: Insulation to be tested 8
Table 4: Peak and ISO amplitudes 13

PACE 101H TECHNICAL MANUAL TABLE OF FIGURES

Figure 1: Timing cycle without intrinsic rhythm 10

Figure 2: Timing cycle with detected R-wave 10
Figure 3: Timing cycle with R-wave in autoshort or blanking 11
Figure 4: Timing cycle with R-wave in noise time 11
Figure 5: Timing cycle with R-wave in refractory time 12
Figure 6: Timing cycle with R-wave after refractory time 12
Figure 7: Stimulation pulse (amplitude 9V, resistive load 500 Ohm) 14
1. FUNCTION CHECK
1.1 Mechanical Inspection
The following inspection must be carried out:
• Inspect the device, connections and accessories for visible damage.
• Open each receptacle and insert 2 mm pin. Tighten both receptacles and check for fast hold by pulling on each pin.
• Open front window panel and check integrity of all dial knobs. Knobs should be tight. Close front panel window.
• Check battery compartment for easy opening and closing. Verify that the 9V battery is in place.
• Check seal on housing screws.

1.2 Electrical Measurement and Inspection

1.2.1 Using a Pacemaker Test Equipment

The electrical part of the function check shall be made with special pacemaker test equipment. There are different models available on
market. The chosen model’s instructions for use must be followed.

The following measurements and inspections must be carried out:

• Measuring the pulse amplitude
• Measuring the pulse width
• Measuring the rate
• Measuring the sensitivity
• Inspecting the battery surveillance

Additionally the following measurements and inspections may be made:

• Measuring the battery surveillance
• Measuring the refractory period
• Measuring the high rate stimulation
• Inspecting the interference behavior

For inspecting and/or measuring the Battery surveillance the following information is given.

If switched on, the pacer measures the battery voltage every second. If the voltage falls under a specified level, the red LED “Low Batt/Error“
flashes and an acoustic signal is given. The flashing interval and the acoustic signal repetition interval depend on the battery level reached.
Table 1 shows the values.

Voltage level LED flashing interval Acoustic signal repetition interval

7.20 V ± 0.20 V 5 sec 5 min
7.00 V ± 0.20V 4 sec 4 min
6.80 V ± 0.20 V 3 sec 3 min
6.60 V ± 0.20 V 2 sec 2 min
6.40 V ± 0.20 V 1 sec 1 min
6.20 V ± 0.20 V 0.2 sec 0.6 min
Table 1: “Low Batt/Error” LED flashing and acoustic signal repetition interval depending on battery level

Pace 101H Technical Manual | Page 4

1.2.2 Using an Oscilloscope and a Signal Generator

If no special pacemaker test equipment is a available then the pulse amplitude, pulse duration, rate and sensitivity may also be inspected by
means of an oscilloscope and a signal generator.

The function check shall start with the following basic inspection :
• Open front window panel of the unit
• Turn Pace 101H on “Mode” dial to “VVI”. The green, red and yellow indicator will light up momentarily
• Turn “mV” dial to “f”. Turn “V” dial to 6. Turn “p/min” (pulses per minute) dial to 60
• Check that the “Stim.” indicator (yellow) is flashing.
• Check that all other indicators (“Sense” and “Low Batt./Error”) are not lit.
• Turn “Mode” dial to VVI Beep and check whether a beep is heard with every “Stim.” indicator flash.
• Turn the unit off.

Assuming there is a 2-Channel Oscilloscope available, then the following table gives a short description of oscilloscope front panel knobs
and their function:

Knob name Function and Select for PACE 101H

Input A
CH A Input channel
Position Moves signal up and down on oscilloscope screen
Polarity DC
Volts/cm 2
Mode A
Power ON/OFF
Intensity Signal brightness
Focus Centralizes light
Sweep/time 0.1 ms, 1 ms, 0.2 s
Triggering IN
Slope –
Coupling DC
Source CH A
Position Moves signal left and right on oscilloscope screen

Pace 101H Technical Manual | Page 5

 Set up of the oscilloscope by carrying out the following steps:
• Turn the oscilloscope ON.
• Verify all knobs are in calibration position.
• Connect oscilloscope test cable to Channel A input.
• Connect test cable to the pin of black receptacle.
• Connect ground wire of test cable to the pin of red receptacle.
• Connect a 500 Ohm load resistor parallel to black and red receptacle.
• Set polarity switch of oscilloscope to “DC”.

Inspecting of pulse amplitude, pulse duration and rate shall be done as follows:
• Turn PACE 101H power ON knob to VVI position.
• Turn “mV” dial to “f”, “V” dial to 6, “p/min” (pulses per minute) dial to 60.
• Verify “trigger” knob of oscilloscope is pushed IN. Turn the knob slowly clockwise until a display of PACE 101H output signals is on screen.
• Set sweep dial of oscilloscope at 1 msec/cm.
• Set sensitivity dial of oscilloscope at 2 V/cm. A signal pulse should appear on screen. The amplitude of the (negative) pulse should be
displayed in 3 cm deflections.
• Set sweep dial of oscilloscope at 0.1 msec/cm. The pulse duration of the (negative) pulse should be displayed in 7.5 cm deflections.
• Set sweep dial of oscilloscope at 0.2 sec/cm. The distance between two pulses should be displayed in 5 cm deflections.
• Set “Mode” dial of PACE 101H to 2X. Press High Rate button and observe the distance between pulses is two times shorter (faster).

Inspecting of sensitivity shall be done as follows :

• Find a signal generator capable for providing triangle test pulses.
• Connect PACE 101H to the signal generator.
• Turn PACE 101H power ON to VVI position.
• Turn “mV” dial to “5”, “V” dial to 6, “p/min” (pulses per minute) dial to 60.
• Supply a triangle test pulse (2 ms rising edge/13 ms following edge ) of 3.0 mV amplitude and 100 p/min repetition rate to PACE 101H.
• Turn “mV” dial slowly clockwise and observe whether the device starts with inhibition at the “3” position. If the PACE 101H switches from
stimulation to inhibition then the green indicator “Sense” flashes instead of the yellow indicator “Stim.”.

Pace 101H Technical Manual | Page 6

2. SAFETY CHECK
This safety check is based on the following international standards:
IEC 60601-1:1988 Medical electrical equipment - Part 1: General requirements for safety
IEC 60601-1/A1:1991 Medical electrical equipment - Part 1: General requirements for safety - Amendment 1
IEC 60601-1/A2:1995 Medical electrical equipment - Part 1: General requirements for safety - Amendment 2
IEC 60601-2-31:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers
with internal power source.
IEC 60601-2-31/A1:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers
with internal power source/Amendment No. 1.

The following measurement equipment and auxiliary means are needed:

• Safety tester according to IEC 60601-1
• Digital multimeter
• Oscilloscope
• High voltage tester
• Metal foil, to get an intimate contact with the insulating enclosure of the PACE 101H
• A metal surface of 20 cm × 25 cm
• Div. leads with 2 mm and 4 mm plugs, measuring probes, a 100 kΩ resistance

From a safety point of view, an external pulse generator belongs to the internally powered equipment class and has a CF degree of
protection against electric shock.

The external pulse generator PACE 101H is characterized as follows: an enclosure made of insulating material; an applied part with the two
patient connections DIFF (black terminal) and INDIFF (red terminal).

The following chapters describe all safety tests contained in the above-mentioned standards, which are applicable to external pulse
generators with internal power supply. As a safety check of the PACE 101H at least measuring the patient auxiliary currents must be
carried out.

2.1 Micro/Macro Shock Protection Tests

The purpose of this test is to verify the micro/macro shock protection according to the above standards which includes measurement of:
• patient leakage current between patient connections and enclosure (source IEC 60601-1, subcl. 19)
• dielectric strength (source IEC 60601-1 subcl. 14.6 c and IEC 60601-2-31 subcl. 5.2, IEC 60601-1 subcl. 20)

The measuring methods of this test shall strongly agree with the respective IEC standards. The test is divided into two parts:
• Measurement of Patient Leakage Current
• Insulation Test

Pace 101H Technical Manual | Page 7

 Table 2 shows the allowable values for the leakage currents.

Current Unit Allowable value

Patient leakage current between diff (“-“, black) connection and enclosure mA 0.01
Patient leakage current between indiff (“+”, red) connection and enclosure mA 0.01
Patient leakage current with voltage 250 VAC applied between diff connection and enclosure mA 0.05
Patient leakage current with voltage 250 VAC applied between indiff connection and enclosure mA 0.05
Table 2: Allowable values for leakage current

Table 3 shows the insulation to be tested.

Insulation to be tested Case B-d (Basic Insulation)

Between enclosure and diff (“-“, black) patient connection

Between enclosure and indiff (“+”, red) patient connection

Table 3: Insulation to be tested

2.1.1 Measurement of Patient Leakage Current

The test shall be carried out with the safety tester. Its instructions for use shall be exactly followed.

For the normal condition the standard ICE 60601-1, subcl. 19.4 h 6 shall be taken into account where figure 23
shows the proper measuring device. The exterior surface of the pacer made of insulating material shall be covered
with a metal foil (according to IEC 60601-1, subcl. 19.4 g 5) of max. 10 x 20 cm, which shall be pressed against
the insulating material of the enclosure (using foam/rubber of the same dimension as the metal foil). According to
the standard IEC 60601-1, subcl. 19.1 e /Appendix K the patient leakage current shall be measured between each
Normal Condition
patient connection and the enclosure covered with the metal foil.The pacer shall be switched on and the following
parameters shall be set: VVI, 6 V,70 ppm, 2 mV.

Single Fault Condition
In particular the patient leakage current shall be measured between the parts and the values shall not exceed the
values given in Table 2.
According to the standard IEC 60601-1, subcl. 19.1 e /Appendix K and the ICE 60601-1, subcl. 19.4 h 7
(measuring device see figure 24) the patient leakage current shall be measured between each patient connection
and the enclosure covered with the metal foil for single fault condition applying 250 V (in accordance with IEC
60601-1, subcl. 19.1 b) to each patient connection. The enclosure made of insulating material shall be placed
in any position of normal use upon a flat metal surface connected to earth with dimensions at least equal to the
planprojection of the enclosure (see ICE 60601-1, subcl. 19.4 h 7). The pacer shall switched on and the following
parameters shall be set: VVI, 6 V,70 ppm, 2 mV. All other constraints described in case of normal condition for
measuring the patient leakage current are also valid for single fault condition.

In particular the patient leakage current shall be measured for single fault condition in following cases:
1. with voltage 250 VAC between diff (“-”, black) connection and enclosure

2. with voltage 250 VAC between indiff (“+”, red) connection and enclosure

The measured values shall not exceed the values given in Table 2.

Pace 101H Technical Manual | Page 8

2.1.2 Insulation Test
The test shall be carried out with the high voltage tester. Its instructions for use shall be exactly followed.

The insulation test shall occur according to IEC 60601-1, subcl. 20.2 B-d. Values of test voltages are specified in IEC 60601-1, subcl. 20.3,
table V. In case of the pacer a basic insulation shall be tested. The exterior surface of the pacer made of insulating material shall be covered
with a metal foil (according to IEC 60601-1, subcl. 19.4 g 5) of max. 10 x 20 cm, which shall be pressed against the insulating material of the
enclosure (using foam/rubber of the same dimension as the metal foil). Care shall be taken that the metal foil is positioned in a manner that
flashover does not occur at the edges of insulation linings. If possible, the metal foil should be moved so as to test all parts of the surface.
During the insulation test the pacer shall be switched off. The insulation test shall be done for a reference voltage of Uref ≤ 50 V . The test
voltage shall be equal to 500 V.

The test shall be carried out in accordance with IEC 60601-1, subcl. 20.4. Initially, not more than 250 V shall be applied, then the test voltage
shall be gradually raised over a period of 10 s to 500 V, which shall be maintained for 1 min. after which it shall be gradually lowered over a
period of 10 s to less than 250 V. The insulation test shall occur between the parts shown in Table 3.

2.2 Measurement of Patient Auxiliary Current

The purpose of this test is to verify the tissue protection, which includes measurement of the patient auxiliary current (source IEC 60601-2-
31, subcl. 19.3 a)

The Patient Auxiliary Current shall be measured according to the standard IEC 60601-2-31, subcl. 19.3 a. The test conditions are described
in the standard IEC 60601-2-31, subcl. 19.4 j 4. For measurement of patient auxiliary current the equipment shall be connected as shown
in figure 27 of the general standard to a d.c. measuring device with an input resistance of 100 kΩ. The equipment shall be connected to the
measuring device for a minimum of 5 min. before making the patient auxiliary measurement. The patient auxiliary current will be measured
just before the pacing pulse. In this case the measured voltage shall not exceed 100 mV . According to the IEC 60601-1, subcl. 19.1 f and g /
Appendix K, the measurement of patient auxiliary current shall be done between the diff connection and the indiff connection.

Pace 101H Technical Manual | Page 9

 3 Pulse Generator Timing
3. PULSE GENERATOR TIMING
3.1 Timing
3.1 Cycle Without Intrinsic
Timing CycleRhythm
Without Intrinsic Rhythm
After the intervention interval (1/basic rate) has elapsed a stimulation pulse will be emitted. Figure
After the intervention
1 shows theinterval
timing. (1/basic rate) has elapsed a stimulation pulse will be emitted. Figure 1 shows the timing.

1. intervention 2. intervention
(pulse width 750µs)
I/O channel
intervention time
min. 330ms
refractory time after
intervention 250ms
noise time
212ms
blanking time after
intervention
80ms
autoshort time
35ms

Figure 1: Figure
Timing cycle
1: Timing cyclewithout intrinsic
without intrinsic rhythm rhythm

3.2 Timing Cycle with Detected R-Wave

3.2 Timing Cycle with Detected R-Wave
The detection
The detection ofinathe
of a R-wave R-wave
sensing in theinhibits
phase sensing the phase
emissioninhibits the
of the next emission
stimulation of and
pulse therestarts
next stimulation pulsethe
all intervals except
and restarts all intervals except the autoshort time. Figure 2 shows the timing.
autoshort time. Figure 2 shows the timing.

detected R-wave intervention

I/O channel

intervention time
min. 330ms
refractory time after
R-wave detection 250ms
noise time
212ms
blanking time after
R-wave detection
80ms
autoshort time

Figure 2:Figure
Timing cycle
2: Timing with
cycle with detected
detected R-wave R-wave

5I-17-033X-B-03 Page 10 of 27

Pace 101H Technical Manual | Page 10

 3.3 Timing Cycle with R-Wave in Autoshort or Blanking
3.3 Timing Cycle with R-Wave in Autoshort or Blanking
During autoshort or blanking no R-wave will be detected. Figure 3 shows the timing.
During autoshort or blanking no R-wave will be detected. Figure 3 shows the timing.

1. event unrecognized intervention

R-wave
I/O channel

intervention time
min. 330ms
refractory time after
R-wave detection 250ms
noise time
212ms
blanking time after
R-wave detection
80ms
autoshort time
35ms

Figure 3: Timing cycle with R-wave in autoshort or blanking

Figure 3: Timing cycle with R-wave in autoshort or blanking
3.4 Timing cycle with R-wave in noise time
3.4 Timing
If thecycle with R-wave
blanking interval in noise
has time the pacemaker can receive signals. But as long as the noise
elapsed
interval hasn’t elapsed, such received signals
If the blanking interval has elapsed the pacemaker can receive will But
signals. be as
recognized as noise.
long as the noise interval As a elapsed,
hasn’t result noise time
such received
and blanking time will be restarted. Refractory time and intervention interval will not be effected
signals will be recognized as noise. As a result noise time and blanking time will be restarted. Refractory time and intervention interval
and continue running. All signals received in the restarted noise interval will be handled in the
will notsame
be effected and continue
manner. If therunning. All signals
intervention receivedelapsed,
interval in the restarted noise intervalpulse
a stimulation will be will
handled
be inemitted
the sameand
manner.
a newIf the
intervention interval will be started. Figure 4 shows the timing.
intervention interval elapsed, a stimulation pulse will be emitted and a new intervention interval will be started. Figure 4 shows the timing.

1. event detected intervention

R-wave
I/O channel

intervention time
min. 330ms
refractory time after
R-wave detection 250ms
212ms
noise time
212ms
blanking time after
R-wave detection
80ms 80ms
autoshort time
35ms

Figure 4: Figure
Timing cycle with R-wave in noise time
4: Timing cycle with R-wave in noise time

5I-17-033X-B-03 Page 12 of 27

Pace 101H Technical Manual | Page 11

 3.5 Timing cycle with R-wave in refractory time
3.5 Timing cycle received
A R-wave with R-wave in refractory
in the refractorytime
time will be assumed as a first noise signal. For this reason a
noise
A R-wave timeinand
received blankingtime
the refractory time
willwill be restarted.
be assumed as a firstRefractory time
noise signal. For thisand intervention
reason interval
a noise time and willtime
blanking notwill
bebe
effected and continue running. Because of the restarted blanking time the pacemaker’s ECG input
restarted. RefractoryFigure
is closed. time and5 intervention
shows theinterval will not be effected and continue running. Because of the restarted blanking time the
timing.
pacemaker’s ECG input is closed. Figure 5 shows the timing.

1. event detected intervention

R-wave
I/O channel

intervention time
min. 330ms
refractory time after
R-wave detection 250ms
noise time
212ms
blanking time after
R-wave detection
80ms 80ms
autoshort time
35ms

Figure 5: Timing cycle

Figure 5: Timing with
cycle R-wave
with R-wave in refractory
in refractory time time
3.5 Timing cycle with R-wave in refractory time
3.6 Timing Cycle received
A R-wave with R-wave After
in the Refractory
refractory Time
time will be assumed as a first noise signal. For this reason a
noise time
After refractory time and blanking
has elapsed timeiswill
a R-wave be restarted.
recognized Refractory
as the patient’s intrinsictime
signal.and
The intervention interval
running intervention willwill
interval not be be
stopped
effected and continue running. Because of the restarted blanking time the pacemaker’s ECG input
and noisstimulation pulse will5beshows
closed. Figure emitted.the
Thetiming.
intervention interval, the refractory time, the noise time as well as the blanking time will be
restarted. Autoshort will not be performed. The timing cycle is shown in Figure 6.

1. event detected intervention

R-wave
I/O channel

intervention time
min. 330ms
refractory time after
R-wave detection 250ms
noise time
212ms
blanking time after
R-wave detection
80ms 80ms
autoshort time
35ms

Figure 5: Timing cycle

Figure 6: Timing cyclewith R-wave
with R-wave in refractory
after refractory time time

5I-17-033X-B-03 Page 14 of 27

Pace 101H Technical Manual | Page 12

4. APPENDICES
4.1 Stimulation Amplitude According to ISO Definition
The amplitude of the stimulation pulse indicated on the PACE 101H scale is equal to the peak pulse amplitude. This was chosen for an easy
measurement of the pulse amplitude, but it differs from the test procedure in ISO 5841-1, Sub clause B.2.2 where the pulse amplitude is
calculated from the time integral over voltage divided by the pulse duration. The pulse duration shall be measured between the points on the
pulse waveform where the amplitude is equal to one-third of the peak pulse amplitude.

With the following equation the ISO-amplitude can be calculated from the peak pulse amplitude:

D : pulse duration (0.75ms)

RL: load resistance
C : capacitor in load circuit (3.3 μF in PACE 101H at resistive load)

Table 4 shows calculated values for standard load RL = 500Ω .

APEAK [V] AISO [V]

1 0.80

2 1.60
3 2.41
4 3.21
5 4.01
6 4.81
7 5.61
8 6.41
10 8.01
12 9.62
Table 4: Peak and ISO amplitudes

Pace 101H Technical Manual | Page 13

 4.2 Waveform of Stimulation Pulse
4.2 Waveform of Stimulation Pulse
Figure 7 shows the waveforms of the stimulation pulse.
Figure 7 shows the waveforms of the stimulation pulse.

Figure 7: Stimulation pulse (amplitude 9V, resistive load 500 Ohm)

Figure 7: Stimulation pulse (amplitude 9V, resistive load 500 Ohm)

4.3 Sensitivity for sin² Test Impulses
The sensitivity S (in mV) of the PACE 101H is adjusted by the manufacturer applying the triangle 2ms/13ms test impulse as specified in ISO
5841-1, Sub clause B.1.4 (SISO). With the following equations the corresponding sensitivities for sin² test impulses can be calculated:

15 ms pulse duration: Ssin2/ 15ms = 0.77 * SISO

25 ms pulse duration: Ssin2/ 25ms = 0.83 * SISO

40 ms pulse duration: Ssin2/ 40ms = 1.19 * SISO

The formulas have to be interpreted as in the following example:

If the sensitivity of the PACE 101H is set to 1 mV and a 15 ms-sin² test impulse is used, it is as if the sensitivity has been set to 0.77 mV.
With other words: A 15 ms-sin² impulse with an amplitude of 0.77 mV will just be recognized by the PACE 101H, when its sensitivity
parameter is set to “1 mV”.

5I-17-033X-B-03 Page 17 of 27
The formulas can also be reversed like in the following example:
When a 15 ms-sin² impulse with an amplitude of 1 mV shall just trigger the PACE 101H, its sensitivity must be set to 1.3 mV (= 1/0.77 mV)

Pace 101H Technical Manual | Page 14

 4.4 Function and Safety Check with SigmaPaceTM 1000

4.4.1 Visual Inspection

1. Ensure that the body of the pacemaker is not damaged.
Record the results (Pass or Fail).

2. Ensure that no label is damaged.

Record the results (Pass or Fail).

3. Ensure that parameter switches (rotary and push buttons) are not damaged.
Record the results (Pass or Fail).

4. Test BLACK and RED receptacles for function by turning of the profile caps.
Record the results (Pass or Fail).

5. Check battery compartment for easy opening and closing.

Record the results (Pass or Fail).

6. Check of condition of battery clip and cable for damages

(Pass or Fail)

7. Check front window panel for easy opening and closing.

Record the results (Pass or Fail).

8. Turn on the pacemaker. Verify that all 3 LED’s are emitting shortly.
Record the results (Pass or Fail).
Turn off the pacemaker. Remove the test battery.

4.4.2 Test Equipment & Test Set Up

Provide the following test equipment:

• Pacemaker Analyser SigmaPaceTM 10001

• 9VDC Load Test Cable
• 2 Test leads
• Test battery
• Power supply with DC voltage regulator
• Voltmeter
• Test cables

1
External Pacemaker Analyser SigmaPaceTM 1000, DNI Nevada Inc., USA

Pace 101H Technical Manual | Page 15

 1. To perform tests and checks the examiner must be familiar with the content of the pacemaker’s instructions for use.

2. Turn on the SigmaPaceTM 1000

Press and release the ENTER/POWER ON KEY.
Press F2 INV for invasive (transvenous) external pacemaker testing.
Press F4 to select the test load of 500 Ohms.
Press F1 NEXT

4.4.3 Supply Current & Power Management

1. Pacemaker: Power OFF
Plug the supplied 9VDC Load Test Cable into the matching connector on the left side of the SigmaPaceTM 1000. Connect the 9VDC Load
Test Cable to Pacemaker battery terminals.
Use F4 to navigate through the available test selections.
Press F2 to select DC LOAD
Press F1 NEXT
Pacemaker Power OFF
Fill in the actual current measurement value in the test protocol.
Pacemaker Power ON Standard (70ppm, 6V, 2mV)
Fill in the actual current measurement value in the test protocol.
Press ESC 2x

2. Remove the supplied 9VDC Load Test Cable from the pacemaker.

3. The following steps should be performed to test the low battery indication circuitry of the pulse generator.
Connect a voltmeter to the Power Supply output terminals. Turn “ON” the Voltage Meter
and set it to V=.
Turn “ON” the Power Supply. Set the Power Supply output to a nominal voltage of 9.00 (±0.1) Volts by rotation the “VOLTAGE
ADJUSTMENT” dial.
Connect test cables between the Power Supply outputs and the battery terminals of the PACEMAKER.

4. Turn “ON” the Pacemaker. Verify that no Low Batt. LED is lightening Record the results (Pass or Fail)..
Switch off the pacemaker
Slowly rotate the “VOLTAGE ADJUSTMENT” dial of the Power Supply counterclockwise and set the Power Supply output to a nominal
voltage of 7.0 Volts.
Switch on the pacemaker
Verify on the pulse generator the following:
a) The “Low Batt. LED” flashes ;
b) An acoustic warning signal is heard

5. Pacemaker: Turn power “OFF”. Remove all the connections from the pacemaker, install the battery and close the battery
compartment door.

Pace 101H Technical Manual | Page 16

 4.4.4 Patient Auxiliary Current
Connect test leads between SigmaPace 1000 (ATRIUM) and pacemaker.

• Patient Auxiliary Current, Static

Use F4 to navigate through the available test selections.
Press F1 to select DC LEAK test
Press F1 OFF to select Static test
Pacemaker: Turn power OFF
Press F1 to select the ATRIAL channel
Press F1 HOLD to freeze the pacer measurement
Fill in the actual pacer measurement data to the test protocol
Press ESC to return to the previous menu

• Patient Auxiliary Current, Dynamic

Pacemaker: Turn power ON,
Press F2 ON to select Dynamic test
Press F1 to select the ATRIAL channel
Press F1 NEXT
Press F1 HOLD to freeze the pacer measurement
Fill in the actual pacer measurement data to the test protocol
Press ESC 2x to return to the previous menu
Pacemaker: Turn power OFF

4.4.5 Pulse Amplitude2

• Pacemaker: Standard (70ppm, 6V, 2mV)
Use F4 to navigate through the available test selections.
Press F1 to select Pulse Output test
Press F1 to select Channel Atr Only
Pacemaker: Set the atrial amplitude according to the test protocol.
Fill in the actual pacer measurement value in the test protocol.
Repeat the steps until the values are complete.
Press ESC to return to the previous menu

4.4.6 Pulse Duration

• Pacemaker: Standard, (70ppm, 6V, 2mV)
Press F1 to select Channel Atr Only
Fill in the actual pacemaker measurement value in the test protocol.
Press ESC to return to the previous menu

2
The pulse amplitude indicated in the pacemaker’s display is equal to the peak pulse amplitude.
The SigmaPace 1000 measures the amplitude according to the ISO definition (see 4.1 Stimulation Amplitude According to ISO Definition).
Therefore, the test protocol distinguishes between amplitude setting value (peak) and nominal value (ISO definition).

Pace 101H Technical Manual | Page 17

 4.4.7 Rate
• Pulse Rate
Pacemaker: Standard, pulse rate variable
Press F1 to select Channel Atr Only
Pacemaker: Set the nominal pulse rate.
Fill in the actual pacemaker measurement value in the test protocol.
Repeat the steps until the values are complete.
Press ESC to return to the previous menu

• High Rate
Pacemaker: Standard, pulse 180ppm
Press F1 to select Channel Atr Only
Pacemaker: Turn to x2 Press High Rate
Press F1 HOLD to freeze the actual pacemaker measurement.
Fill in the actual pacer measurement value in the test protocol.
Pacemaker: Turn to x4 Press High Rate
Press F1 HOLD to freeze the actual pacemaker measurement.
Fill in the actual pacer measurement value in the test protocol.
Press ESC 2x to return to the previous menu.

4.4.8 Sensitivity3
• Pacemaker: Standard, atrial sensitivity variable
Use F4 to navigate through the available test selections.
Press F2 to select SENSE AMP
Press F1 to select ATR Channel.
Press F1 NEXT
Press F3 to select ISO WAVE 2/13ms WIDTH
Press F1 NEXT
Pacemaker: Set the nominal atrial sensitivity.
Press F3 POL to select the nominal polarity.
Press F4 AMP ▲▼ to increase or decrease the nominal amplitude until the pacemaker
senses the signal continuously.
Fill in the actual sense amplitude value in the test protocol.
Repeat the steps until the values are complete.
Press ESC 3x to return to the previous menu.

3
Sensitivity with ±20% tolerances because of manual determination with SigmaPaceTM 1000

Pace 101H Technical Manual | Page 18

 4.4.9 Noise Detection
• Pacemaker: Set Standard
Use F4 to navigate through the available test selections.
Press F3 to select NOISE LINE
Press F3 to select 50Hz LINE
Press F1 NEXT
Pacemaker: The Sense-LED shall NOT lights up.
Press F3 to select ECG ON
Pacemaker: The Sense-LED shall NOT lights up.
Fill in the results in the test protocol.
Press ESC to return to the previous menu.
Press F3 to select 60Hz LINE
Press F1 NEXT
Pacemaker: The Sense-LED shall NOT lights up.
Press F3 to select ECG ON
Pacemaker: The Sense-LED shall NOT lights up.
Fill in the results in the test protocol.
Press ESC 2x to return to the previous menu.

4.4.10 Refractory Period

• Pacemaker: Set Standard, 10mV sensitivity.
Use F4 to navigate through the available test selections.
Press F1 to select REFRCT DEMAND
Press F1 ATR Channel.
Press F3 to select ISO WAVE 2/13ms WIDTH
Press F1 NEXT
Press F1 START
Wait until the pacemaker measurement is complete.
Add 13 to SRP value4.
Fill in the actual PRP and the corrected SRP measurement value in the test protocol.
Press ESC 2x to return to the previous menu.

• Hold ESC for 2sec. to turn off the SigmaPace 1000

4
Test signal duration

Pace 101H Technical Manual | Page 19

 PACE 101H Inspection Checklist

Date

Examiner / Inspector Device Information

Name Order #

Title Serial #

Inspecting Department Equipment #

Inspection Description

Visual Inspection Nominal Actual

Case Condition Pass

Labels Condition Pass

Verify Parameter Switches Pass

Verify BLACK and RED Receptacles Pass

Battery Compartment and Clip Condition Pass

Front Window Panel Pass

Verify LED Emitting Pass

Supply Current & Power Management Nominal Actual

Verify Current Power Off 0 μA μA

Verify Current Power On (Std. 70ppm, 6V, 2mV) < 800 μA μA

Verify Battery Supervisory Full Battery Condition Pass

Change Battery @ 7.0 V Power Supply Pass

Patient Auxiliary Current Nominal Actual

Patient Auxiliary Current, Static < 1 μA μA

Patient Auxiliary Current, Dynamic < 1 μA μA

WARNING This document is not intended to replace the preventative maintenance testing protocols implemented by your institution. This document is only intended to provide
supplementary testing protocols that the institution in question can elect to add to their own procedure should they deem fit and serves as an example of how the manufacturer would
verify key functional aspects of the device.

Pace 101H Technical Manual | Page 20

 PACE 101H Inspection Checklist

Inspection Description

Pulse Amplitude Setting Nominal ISO Actual ISO

1.0 V 0.62 – 0.98 V V

2.0 V 1.34 – 1.86 V V

500 Ω Load
0.75 ms Pulse Duration 4.0 V 2.78 – 3.63 V V

8.0 V 5.669 – 7.151 V V

0.3… 12 V ± 10 % ± 0.1 V
10.0 V 7.109 – 8.911 V V

12.0 V 8.558 – 10.682 V V

Pulse Duration Nominal Actual AAI

0.75 ms ± 0.05 ms 0.75 ms ms

Pulse Rate Nominal Actual

30 ppm ppm

60 ppm ppm
30 ppm … 180 ppm ± 10 %
100 ppm ppm

180 ppm ppm

High Rate Atrial Channel 360 ppm ppm

180 ppm x2 x4 ± 10 % 720 ppm ppm

Actual AAI Actual AAI

Sensitivity Nominal Positive (+) Negative (-)
5.00 mV mV mV
1 … 20 mV ± 20 % 10.00 mV mV mV

20.00 mV mV mV

Noise Detection No Sense LED Nominal Actual

50Hz ECG Off Pass

50Hz ECG On Pass

60Hz ECG Off Pass

60Hz ECG On Pass

WARNING This document is not intended to replace the preventative maintenance testing protocols implemented by your institution. This document is only intended to provide
supplementary testing protocols that the institution in question can elect to add to their own procedure should they deem fit and serves as an example of how the manufacturer would
verify key functional aspects of the device.

Pace 101H Technical Manual | Page 21

 PACE 101H Inspection Checklist

Inspection Description

Refractory Period Nominal Actual

Refractory Period Atrial Channel after Atrial Pacing (PRP) 250 ms ± 5 % ms

Refractory Period Atrial Channel after Atrial Sensing (SRP) 250 ms ± 5 % ms

SUMMARY Nominal Actual

Pacemaker Function and Safety Check Pass

Comments

EXAMINER / INSPECTOR - AUTHORIZED SIGNATURE

WARNING This document is not intended to replace the preventative maintenance testing protocols implemented by your institution. This document is only intended to provide
supplementary testing protocols that the institution in question can elect to add to their own procedure should they deem fit and serves as an example of how the manufacturer would
verify key functional aspects of the device.

Pace 101H Technical Manual | Page 22

Pace 101H Technical Manual | Page 23
Oscor Inc.
3816 DeSoto Blvd.
Palm Harbor, FL 34683
P: 727.937.2511
F: 727.934.9835
www.oscor.com

5L-17-030Z-X-03
10 Feb 2014