Pacetronix INDUS-1 Manuel utilisateur

SHREE PACETRONIX LTD.

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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

SHREE PACETRONIX LTD.

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Revision

Date

Change Description

January 8

, 2014

New EC Rep

August 21

, 2020

EC Rep & User Information

July 1

, 2021

Specification

Oct 20

, 2021

Specification

SHREE PACETRONIX LTD.

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Explanation of Symbols:

Sr.

No Symbol Symbol Explanation

Operating instructions

Type CF applied part.

Do not dispose of this product in the unsorted municipal waste

stream. Dispose of this product according to local regulations

Package contents

Product documentation

Temperature limitation

7. Serial number

8. Manufacturer

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

SHREE PACETRONIX LTD.

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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

SHREE PACETRONIX LTD.

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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.

SHREE PACETRONIX LTD.

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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.

SHREE PACETRONIX LTD.

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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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