Pacetronix INDUS-1 User manual

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SINGLE CHAMBER
EXTERNAL PACEMAKER
INDUS-I
MODEL : SSB-100
Instruction
manual
Shree Pacetronix Ltd
Plot no. 15, sector II,
Pithampur, Dist.: Dhar
Madhya Pradesh
Email: pace[email protected]
Website: www.pacetronix.com

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Revision
Date
Change Description
02
January 8
th
, 2014
New EC Rep
03
August 21
st
, 2020
EC Rep & User Information
04
July 1
st
, 2021
Specification
05
Oct 20
th
, 2021
Specification

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Explanation of Symbols:
Sr.
No Symbol Symbol Explanation
1.
Operating instructions
2.
Type CF applied part.
3.
Do not dispose of this product in the unsorted municipal waste
stream. Dispose of this product according to local regulations
4.
Package contents
5.
Product documentation
6.
Temperature limitation
7. Serial number
8. Manufacturer
9.
Date of manufacture
10.
DEFIBRILLATION - PROOF TYPE CF APPLIED PART.
11.
General warning sign
12.
Battery (9V , PP3)

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Contents
1. General Description...........................................................................6
a. Indications for use.........................................................................6
b. Contraindications.......................................................................7
2. Package Contents...............................................................................9
3. Safety Features...................................................................................9
4. Specification........................................................................................9
4.1 Technical Data ............................................................................10
4.2 Mechanical Data .........................................................................11
4.3 Nominal Values...............................Error! Bookmark not defined.
5. Function and Description................................................................12
5.1 Functional Indicators .................................................................12
5.1.1 Pacing.....................................................................................12
5.1.2 Sensing...................................................................................12
5.1.3 Low Battery indication ..........................................................12
5.2 Controls........................................................................................12
5.2.1 Rate (ppm) .............................................................................12
5.2.2 Output / Pulse Amplitude (Volts)..........................................13
5.2.3 Sensitivity (milli Volts) .........................................................13
5.2.4 Mode ......................................................................................13
6. Operating Instructions....................................................................14
6.1 On / Off Switch...........................................................................14
6.2 Rate Controls..............................................................................14
6.3 Sensitivity control........................................................................14
6.4 Demand and asynchronous Modes ............................................14
6.5 Collet terminals............................................................................14
6.6 Lead placement............................................................................15
6.7 Battery replacement.....................................................................16
7. Interference Rate, High Rate protection & O/D facility..............16

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7.1 Interference .................................................................................16
7.2 High Rate protection...................................................................16
7.3 Over drive facility ........................................................................17
8. Mode definitions...............................................................................17
9. Device Maintenance.........................................................................17
9.1 Cleaning.......................................................................................17
9.2 Safety & Technical checks..........................................................18
9.3. Device Disposal............................................................................18
10. Warnings...........................................................................................18
11. Precautions .......................................................................................20
12. Further information.........................................................................22
13. Limited One Year Warranty..........................................................23

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1. General Description
_________________________________________________________________
The Pacetronix Indus-I Model SSB-100 is a Battery powered, Single
Chamber cardiac pacemaker designed primarily for temporary
antibradycardia pacing therapy in asynchronous or demand (synchronous)
modes. High rate burst pacing therapy tachyarrhythmias, is available in the
asynchronous mode.
In designing these pacemakers, the emphasis has been on producing a rugged
battery powered pacemaker that is small and light enough to be comfortably
attached to a patient, yet possesses all the attributes of our reliable bedside
units.
Stimulation is indicated by synchronous flashing of ‘Red LED’ & sensing is
indicated by synchronous flashing of ‘Green LED’. INDUS-I MODEL SSB-
100 can function in both demand and asynchronous modes with the selection
of pacing rates between 30 - 200 PPM. Over drive is also provided for
terminating Tachycardia’s. For overdrive the asynchronous mode has to be
selected first and the rate knob will provide and increased frequency range
from 80 PPM to 800 PPM. The push button is provided in the recess as a
safety measure and can be operated by pressing it slightly.
In the presence of excessive level of electrical interference, the pacemaker will
automatically switch from the demand mode (VVI) to a temporary
asynchronous pacing mode (VOO) at the selected basic rate. Normal function
is resumed when the level of interference is reduced.
a. Indications for use
Indus-I Model SSB-100 are single chamber anti-bradycardia external devices
intended for temporary ventricular or atrial pacing applications. Their use
may be indicated in the treatment of patients with deficient cardiac impulse
generation systems or with deficient conduction.

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b. Contraindications
There are not general contraindications to the use of ventricular pacing as a
means of controlling heart rate. However, the patient's age and medical
condition may dictate the particular pacing system and mode of operation
used by the physician.
Indus-I Model SSB-100 devices are contraindicated for atrial pacing in the
presence of an A-V conduction disturbance.
Indus-I Model SSB-100 devices are contraindicated for asynchronous pacing
in the presence of competitive rhythms as well as in the presence of
competition between paced and intrinsic rhythms.

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Figure : 01

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2. Package Contents
________________________________________________________________
•Miniature external cardiac pacemaker type INDUS-I MODEL SSB-100.
•One 9V Alkaline battery.
•Instruction / Technical manual.
•Carrying case.
Note: Check the package prior to use.
3. Safety Features
________________________________________________________________
The Shree Pacetronix Model ‘Indus-I Model: SSB-100’ is designed to be reliable,
simple to operate, and comfortable to hold. Safety features of SSB 100 include:
•Low Battery indicator.
•Continuous operation during battery replacement.
The battery change over time is approx 16 sec. to 20 sec.
•Protective covers over the controls and a rubber seal covering.
•Pacing and Sensing LEDS.
•Safety cables.
•Runaway rate protection;
•Electrostatic protection.
•Minimized susceptibility to electromagnetic and magnetic interference.
4. Specification
______________________________________________________________
The external demand pacemaker INDUS-I MODEL SSB-100 is the result of
longtime experience in development and production of cardiac pacemakers.
INDUS-I MODEL SSB-100 provides a safe and effective heart stimulation
indicated by rhythm and conduction defects, termination of bradycardias at the
time of implant or exchange of a pacemaker.
The optimal conception of INDUS-I MODEL SSB-100 provides an easy and
safe application under consideration of all the necessary aspects of practice of
the pacemaker-therapy. An Overdrive-Stimulation for terminating tachycardia
is performed with the possibility of increasing the frequency. Stimulation is
indicated by synchronous flashing of ‘RED LED’ & Sensing is indicated by
synchronous flashing of ‘GREEN LED’. Mains independence battery
operation provides a maximum on electric safety for both patient and user.

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4.1Technical Data
PARAMETERS VALUES
Description of Pacemaker External pacemaker
Mode AOO, AAI, VVI, VOO, Urgent
Output Pulse Amplitude 0.1 to 18 Volts ± 10% at 510 ohm Load
Detection of output pulse Red LED flashes synchronously to every stimulation pulse.
Pulse Width 1.50 ms ± 5%
P/R Sensitivity 0.4 mV to 20 mV ± 20%
Basic Pacing Rates 30 to 250 PPM
Over Drive rates 60 to 1000 PPM ± 15 PPM
Input Impedance 8 K Ohms ± 10%
Refractory Period UPTO 50PPM - - 500ms
UPTO 70PPM - - 300ms
UPTO 90PPM - - 250ms
UPTO 110PPM - - 200ms
UPTO 130PPM - -180ms
UPTO 250PPM - -150ms
±15% for all values
4.2Features
PARAMETERS VALUES
Pause Button Output will be paused for max. 10 sec. when pressed.
Lock After every 20 cycles device will be locked
automatically.
To unlock press “Pause / Unlock” button.
ON / OFF Button Separate ON and OFF button
(Press OFF button twice to ‘switch off’ the device)
Noise detection Signal >10Hz freq., Causes the device to switch to
asynchronous stimulation mode (VOO).
Low Battery Indicator •Continuous battery monitoring.
•Change battery, when low battery indicator (Red

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LED) ‘ON’
•Battery replacement time approx. 50sec
Urgent Mode Parameters: 80 PPM, 8 Volts
Defibrillation protection Yes
Indication Pace Indication: Flashing ‘RED LED’.
Sense Indication: Flashing ‘GREEN LED’.
Buzzer If Lead is open or short then buzzer will blow for every
16 cycle.
4.3Mechanical Data
PARAMETERS VALUES
Connection of Lead
1.8 to 2.3 mm Diameter
Dimension 200 x 110 x 32 mm
Weight 400 gm (with battery)
Operating Temperature 170C to 330C (640F to 920F)
Storage without Battery 50C to 700C (-400F to 1580F)
Battery Life 200 hrs (At 60 PPM, 5 Volts)
Battery Chemistry Duracell 9V PP3 Alkaline battery
Connection of Lead Security sockets, 1.8 to 2.3mm Diameter
Enclosure Material Acrylonitrile butadiene styrene

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5. Function and Description
_________________________________________________________________
5.1 Functional Indicators
5.1.1 Pacing
Stimulation is indicated by synchronous flashing of “Red LED” once
for every pulse delivered by the pacemaker.
5.1.2 Sensing
Sensing is indicated by synchronous flashing of “Green LED” once for
every pulse sensed by the Pacemaker.
5.1.3 Low Battery indication
It is recommended to replace battery when Low battery Indicator
LED glows.
Normally the LED is OFF when the battery condition is good. As soon
as the battery voltage drops below 6V the Low Battery Indicators LED
will glow. In this condition the unit will continue to Pace, but it is
recommended to change the battery as soon as possible. The Battery
change over time is approx 50 ±5 sec.
5.2 Controls
All controls available are Rotary Knobs calibrated for the Parameters.
5.2.1 Rate (ppm)
This knob is to select different rate values at which pacing
pulses are delivered. It allows continuous adjustment of
the rate from 30 to 250 PPM.
Description of Rate: The pacing rate refers to the average
number of pacemaker’s output pulses occurring over a
specific period of time, usually one minute.

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Rate (ppm) = 60000/ Interval (ms)
5.2.2 Output / Pulse Amplitude (Volts)
This knob is used to set pulse Amplitude in volts values. It
allows continuous adjustment of the amplitude from 0.1 to
18 Volts.
Description of Pulse Amplitude:- It is the electrical
pressure that causes electric current to flow.
5.2.3 Sensitivity (mV)
This knob is used to set sensitivity (mV) values. It allows
continuous adjustment of the Sensitivity from 0.4 to 20
mV.
Description of Sensitivity:- Sensitivity is the ability of
the pacemaker to see intrinsic cardiac events (P/R Wave).
5.2.4 Mode
This switch is used to set desired Mode. Asynchronous
and Demand
Description of Mode:- This parameter defines the
functionality of Pacemaker.
It is defined by the 3 position NBG code as below :--
The “60,000” Rule
60,000 divided by the ‘RATE’ equals the ‘INTERVAL’
60,000 divided by the ‘INTERVAL’ equals the ‘RATE’
60,000
Interval Rate

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I
II
III
Chamber(s) Paced
Chamber(s) Sensed
Mode(s) of Response
O - None
A - Atrium
V - Ventricle
D - Dual (A+V)
O - None
A - Atrium
V - Ventricle
D - Dual (A+V)
O - None
T - Triggered
I - Inhibited
D - Dual (T + I)
S = Single (A or V)
S = Single (A or V)
Asynchronous. Mode :-- SOO / VOO / AOO
Demand Mode :-- SSI / VVI /AAI
6. Operating Instructions
_______________________________________________________________
6.1 On / Off Switch
Switches the unit On and Off. (ON/OFF switch
mounted on front panel of Unit).
6.2 Rate Controls
Adjusts the frequency at which pacing pulses are generated. The
available pacing range is from 30 to 250 PPM. Overdrive stimulation
is also provided for terminating tachycardia. For overdrive, select
asynchronous mode first and then push overdrive button to get
pacing frequency range from 60 PPM to 1000 PPM. The push
button is provided in the recess as a safety measure and can be
operated by pressing it slightly with any pointed stick.
6.3 Sensitivity Control
Adjusts the P/R wave sensing level. The sensitivity level is ineffective
when in “Asynchronous” mode.
6.4 Demand and Asynchronous Modes
This decides the mode of operation.
Demand Modes available are AAI / VVI
Asynchronous Modes available are AOO / VOO
6.5 Collet Terminals

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Accepts External-pacing leads ranging from 1.8 to 2.3 mm diameter.
6.6 Lead placement
a). When positioning the lead in the heart it is recommended that the
ECG should be monitored in order that the S-T segment elevation,
indicating contact with the myocardium and impaction, can be noted.
b). Connecting the lead to the PSA
Switch the PSA to OFF.
Connect the proximal electrode to the indifferent (+) red terminal and
the distal electrode to the active (-) black terminal by using a PSA
cable between Permanent lead and PSA as described in the method
below.
Method : Twist the terminal caps counter clockwise, push the lead
electrodes into the end of the collets terminals, tighten the leads by
twisting caps clockwise.
Caution : The terminal caps should not be over tightened otherwise
the terminal may break.

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6.7 Battery Replacement
It is recommended to replace battery when Low battery Indicator
LED glows.
In the Low Battery case the unit will continue to pace normally, on the
last set parameters but the battery should be replaced as soon as
possible.
Under normal conditions at nominal values (see “Nominal values”
section 4.3) of continuous operation, a 9V alkaline battery will have a
service life of approximately 200 hours on full battery and device
service life is 5 years.
NOTE: We recommend having a spare battery all the times. The
battery should be removed if the device is placed in storage.
As an additional safety precaution the battery and contact terminals
should be checked for corrosion at regular intervals. Use of other than
the recommended batteries may result in one of the following
conditions: (1) less than 24 hours of operation after the low-battery
indicator comes on, (2) degraded pacemaker performance, and/or (3)
overall reduced battery life.
7. Interference Rate, High Rate protection & O/D facility
_______________________________________________________________
7.1 Interference
When operating in the Demand mode, an excessive level of electrical
interference (e.g diathermy or microwave ovens) will cause the pacemaker
to switch automatically in “Asynchronous” pacing at the set rate
(frequency). Normal function is resumed when the level of interference is
reduced.
7.2 High Rate protection
If an electronic component failure occurs in the unit, the maximum high
asynchronous rate is restricted to 200 PPM.

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7.3 Over drive facility
Overdrive stimulation is provided for terminating
tachycardia. For overdrive the ‘Asynchronous’ mode has
to be selected first and the rate knob will provide an
increased frequency range from 60 PPM to 1000 PPM
after pressing the push button “OD”.
If overdrove (O/D) button is pressed in demand mode, the
unit will operate at runway limit of 200 PPM.
8. Mode definitions
_______________________________________________________________
Single Chamber Modes
The Model SSB 100 will pace in two single chamber modes: SOO & SSI.
SOO Modes (AOO) / VOO)
The asynchronous mode (A00 or VOO) emit a pacing pulse into one chamber, either
the atrium (AOO) or the ventricle (VOO),at the end of the base rate interval,
regardless of any intrinsic activity. When pacing in the A00 mode, the pacemaker will
pace the atrium asynchronously at the programmed base Rate. When pacing in the
VOO mode, the pacemaker will pace the ventricle asynchronously at the programmed
base Rate.
SSI Modes (AAI / VVI)
In the demand mode (AAI or VVI), when an intrinsic beat is sensed outside of a
refractory period and before timeout of the base rate interval, the pacemaker inhibits
the output pulse. If no intrinsic beat is sensed before the timeout of the base rate, a
pacing stimulus is delivered. When pacing in the AAI mode, the pacemaker will pace
the atrium at the programmed base rate in the absence of detected atria activity.
When pacing in the VVI mode, the pacemaker will pace the ventricle at the
programmed base rate in the absence of detected ventricular activity.
9. Device Maintenance
9.1 Cleaning
Single Chamber External Pacemaker
The Model SSB 100 external pacemaker can be cleaned using a sponge
or cloth moistened with water or 70% isopropyl alcohol.

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Note: Do not expose the unit to ethers, acetone, or chlorinated solvents
as these may damage the case or labels.
Caution: The Model SSB 100 must not be immersed in water or
cleaning agents. Severe damage to the device may occur.
Connecting Cables
The Patient Cables supplied are sterilized by ethylene oxide.
Prior to sterilization, Patient Cable should be cleaned thoroughly with
a mild detergent or 70% isopropyl alcohol to remove all visible blood
and body fluids. The cables may be immersed for cleaning. The cables
must be thoroughly dried after cleaning. Inspection and testing by a
qualified technician should be done after cleaning to verify proper
cable function.
9.2 Safety & Technical checks
Safety and technical checks should be carried out on the Model SSB
100 at least once every 6 months and after any malfunction or accident.
Pacetronix does not recommend field repair of the device. For service
or repair contact your local Pacetronix representative at the appropriate
address.
9.3.Device Disposal
Obsolete equipment should be returned to company for proper disposal.
Medical equipment may be considered for disposal as a result of its
natural obsolescence, failure to meet current treatment standards, poor
serviceability etc.
As a minimum requirement the following steps should be taken –
1. Remove the outside case of the equipment.
2. Disassemble the unit.
3. The unit is then sent to stores as a rejection.
10. Warnings
Equipment Modification
Do not modify this equipment. Modifications could impact device
effectiveness and adversely affect patient safety.

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Line-powered Equipment
An implanted lead or lead with extension cable constitutes a direct,
low-resistance current pathway to the myocardium. Due to the danger
of fibrillation resulting from alternating current leakage, extreme
caution must be taken to properly ground all line-powered equipment
used on or in the vicinity of the patient.
Electro surgery
Electro surgery can induce ventricular fibrillation, and thus should
never be used within 15 cm (6 inches) of an implanted lead system.
Electromagnetic Interference (EMI)
All pacemakers operating in the demand mode respond to intra cardiac
potentials of a magnitude of a few millivolts. They are inherently
sensitive to some external fields. In the presence of excessive levels of
interference the Model SSB 100 may inhibit completely or revert to
asynchronous operation, pacing at the rate set by the RATE knob. It is
recommended that the device be set to an asynchronous mode when
operated in the presence of strong electromagnetic interference (EMI).
Some sources of excessively strong EMI which may temporarily affect
the operation of the Model Indus are:
•Electrosurgical equipment
•Diathermy equipment
•Some medical telemetry equipment (when operated within one
meter [several feet] of the pacemaker).
•Communication transmitters such as cellular phones and
“walkie talkies”.
•Communication transmitters in emergency transport vehicles
(in the presence of an active pacemaker) and
•Magnetic Resonance Imaging (MRI) equipment.
Defibrillation / Cardioversion
Defibrillation discharges of 360 watt-seconds have not affected the
Model SSB 100 in laboratory tests. However, for maximum safety it is
recommended that the paddles not be placed near the Model SSB 100
or the lead system. Whenever possible, for the safety of the patient,
disconnect the pacemaker from the lead system before defibrillating or
cardioverting. A relatively low resistance pathway exists between the
positive (+) and negative (-) electrodes of the implanted lead system.
During defibrillation a large current could flow across this pathway,
causing myocardial damage.

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Connecting the Lead System
The patient cable should be connected to the external pacemaker
before the lead system is connected to the patient cable.
Turning the Device On
Patient lead, cable and device connections should be made before the
pacemaker is powered on.
11. Precautions
_________________________________________________________________
General
Only authorized medical personnel must operate the INDUS-I
MODEL SSB-100 Single chamber external Pacemaker.
Continuous ECG monitoring is necessary prior to pacing and during
any pacing procedure. Facilities for defibrillation, I.V. infusion, end
tracheal intubation and oxygen administration must be immediately
available.
These miniature External pacemakers are protected against damage
due to defibrillator procedures, but care should be exercised in the
placing of the defibrillator electrodes away from the pacing leads.
Great care should be exercised when using diathermy in association
with any cardiac pacing system. Adequate monitoring must be used.
Mains (Line) powered monitoring equipment is to be avoided when
pacing, since even very less alternating leakage currents flowing
through the heart may cause ventricular fibrillation. If mains (line)
powered equipment is used, the manufacturers, or the person
responsible for safety within your organization should be consulted on
the safest method of connection.
The miniature External pacemaker described in this manual is not
waterproof, and they must not be autoclaved or irradiated.
We recommend that only trained Pacetronix staff performs other repair
and maintenance operations.
We recommend the External pacemaker should be checked for
calibration at every six months interval.
CAUTION: The control knobs are individually calibrated. The
External pacemaker will require to be re-calibrated if they are removed
for any reason.