Pacetronix INDUS-1 User manual

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 1of 23
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

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 2of 23
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

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 3of 23
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)

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 4of 23
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

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 5of 23
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

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 6of 23
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.

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 7of 23
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.

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 8of 23
Figure : 01

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 9of 23
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.

SHREE PACETRONIX LTD.
-----------------------------------------------------------------------------------------------------------
Page 10 of 23
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