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S
P
L
HREE
ACETRONIX
TD.
-----------------------------------------------------------------------------------------------------------
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:
pacetronix@hotmail.com
Website: www.pacetronix.com
Page 1 of 23
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Summary of Contents for Pacetronix INDUS-1
- Page 1 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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: pacetronix@hotmail.com Website: www.pacetronix.com Page 1 of 23...
- Page 2 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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 Page 2 of 23...
- Page 3 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Explanation of Symbols: 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 Serial number Manufacturer Date of manufacture...
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Page 4: Table Of Contents
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Contents 1. General Description ................6 a. Indications for use ................. 6 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 ....... - Page 5 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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.
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Page 6: General Description
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- General Description _________________________________________________________________ The Pacetronix Indus-I Model SSB-100 is a Battery powered, Single Chamber cardiac pacemaker designed primarily temporary antibradycardia pacing therapy in asynchronous or demand (synchronous) modes. High rate burst pacing therapy tachyarrhythmias, is available in the asynchronous mode. -
Page 7: Contraindications
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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. - Page 8 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Figure : 01 Page 8 of 23...
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Page 9: Package Contents
Note: Check the package prior to use. 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. -
Page 10: Technical Data
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 4.1 Technical 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 ±... -
Page 11: Mechanical Data
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- LED) ‘ON’ • Battery replacement time approx. 50sec Urgent Mode Parameters: 80 PPM, 8 Volts Defibrillation protection 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. -
Page 12: Function And Description
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Function and Description _________________________________________________________________ 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. -
Page 13: Output / Pulse Amplitude (Volts)
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Rate (ppm) = 60000/ Interval (ms) 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 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. -
Page 14: Operating Instructions
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Chamber(s) Paced Chamber(s) Sensed Mode(s) of Response O - None O - None O - None A - Atrium T - Triggered A - Atrium V - Ventricle I - Inhibited V - Ventricle D - Dual (A+V) D - Dual (T + I) D - Dual (A+V) S = Single (A or V) -
Page 15: Lead Placement
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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. -
Page 16: Battery Replacement
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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. -
Page 17: Over Drive Facility
HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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”... -
Page 18: 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. - Page 19 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- 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.
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Page 20: Precautions
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. - Page 21 HREE ACETRONIX ----------------------------------------------------------------------------------------------------------- Random Failures The physician should be aware that the Model SSB 100 external Pacemaker can fail due to a number of reasons, such as random component failure, battery depletion, and mishandling. Possible malfunctions of the Model SSB 100 can include: •...
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Page 22: Further Information
To prevent unauthorized changes of pacemaker settings, the device is protected with a cover. Further information _________________________________________________________________ For any further information please contact : Shree Pacetronix Ltd. Plot No.15, Sector II, Pithampur, Dist. Dhar (M.P.) 454775 Contact: 07292 411105 Fax: 07292 400418 Email: pacetronix@hotmail.com... -
Page 23: Limited One Year Warranty
No warranty or replacement agreement whatsoever is made or given as to leads or adapters, battery and arm strap. 2. Limitation of Liability, Shree Pacetronix Ltd. shall not be liable for any medical expenses, adverse body reactions, or medical complications or other...