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Pacetronix ZEUS-1, Руководство пользователя

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Equipment Modification 
 

Do not modify this equipment. Modifications could impact device effectiveness 
and adversely affect patient safety. 
 

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 Zeus-1 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 Zeus-1 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. 
 
 
 

Содержание ZEUS-1

Страница 1: ...DUAL CHAMBER EXTERNAL PACEMAKER Shree Pacetronix Ltd Plot no 15 sector II Pithampur Dist Dhar Madhya Pradesh India Email pacetronix hotmail com Website www pacetronix com ...

Страница 2: ...Revision Date Change Description 01 January 15th 2019 IFU 02 August 21st 2020 User Information 03 October 20th 2021 Specification Sticker Document Man_Zeus 1 Rev 03 20102021 ...

Страница 3: ...spose 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 ...

Страница 4: ...VI mSec A V Interval 13 5 2 3 A Output Volts Atrium Pulse Amplitude 13 5 2 4 A Sens mV Atrium Sensitivity 14 5 2 5 Mode 14 5 2 6 Refractory Period A V 14 5 2 7 V Output Volts Ventricle Pulse Amplitude 15 5 2 8 V Sens mV Ventricle Sensitivity 15 6 OPERATING INSTRUCTIONS 16 6 1 RAP Button 16 6 2 ON Switch 16 6 3 OFF Switch 17 6 4 Pause Unlock Button 17 6 4 1 Device LOCK 17 6 5 Knob Controls 17 6 6 D...

Страница 5: ...7 MODE DEFINITIONS 20 8 DEVICE MAINTENANCE 23 8 1 Cleaning 23 8 2 Safety Technical checks 23 9 WARNINGS 23 10 PRECAUTIONS 26 11 FURTHER INFORMATION 29 12 LIMITED ONE YEAR WARRANTY 30 ...

Страница 6: ...small and light enough to be comfortably attached to a patient yet possesses all the attributes of reliable bedside units Stimulation is indicated by synchronous flashing of PACE sensing is indicated by synchronous flashing of SENS The Zeus 1 can function in both demand and asynchronous modes with the selection of pacing rates between 30 to 200 ppm In the presence of excessive level of electrical ...

Страница 7: ...ZEUS 1 ...

Страница 8: ...ng LEDS for both Atrium Ventricle Safety cables Defibrillator and Electrostatic protection Minimized susceptibility to electromagnetic and magnetic Interference 4 SPECIFICATION _________________________________________________________________ The Dual chamber external pacemaker Zeus 1 is the result of longtime experience in development and production of cardiac pacemakers Zeus 1 provides safe and ...

Страница 9: ...Rate 30 BPM Min 110 BPM Rapid Atrial Pacing 60 to 1000 BPM Amplitude A 0 1 TO 18 Volts at 510 Ω load Amplitude V 0 1 TO 18 Volts at 510 Ω load Sensitivity ATRIUM 0 4 To 10 mV VENTRICLE 0 8 To 20 mV Mode AOO AAI DOO DVI DDI DDD VDD VVI VOO AV Delay 20 to 300 ms Pulse Width 1 0 1 5 ms V Blanking Period 125 ms Pace 75ms Sense Refractory PVARP in DDD Atrium 150 500ms Ventricle 250ms Battery Life 166 h...

Страница 10: ...ng GREEN LED s on the front panel for both Atrial Ventricle Low Battery Indicator Replace battery as Low battery Indicator RED LED glows Battery Replacement time approx 15 Sec Buzzer Alarm For lead integrity ...

Страница 11: ...utton to start and stop the device Lead Temporary lead 4 2 Mechanical Data PARAMETERS VALUES Length x Width x Thick 200 mm x 110 mm x 32 mm Mass gm and Volume cc 400 with battery and 704 cc Connection of Lead Security sockets 1 8 to 2 3mm Diameter Enclosure Material Acrylonitrile butadiene styrene 4 3 Urgent Values PARAMETERS VALUES Rate 80 ppm Amplitude A 10 0 Volts Amplitude V 10 0 Volts Mode DO...

Страница 12: ...the front panel for both A V 5 1 3 Low Battery indication It is recommended to replace battery when Low battery Indicator LED glows Normally the display is at Full intensity when the battery condition is good As soon as the battery voltage drops below 6V the Low Battery Indicators LED will glow Battery Replacement time is approx 15 Sec 5 2 Controls All controls available are Rotary Knobs calibrate...

Страница 13: ...d a Ventricular output pulse Note If A V interval is set shorter than blanking period set value than Ventricular events may not be sensed Also AV interval cannot be less than blanking period AVI less than 90 ms can be set in DOO mode only 5 2 3 A Output Volts Atrium Pulse Amplitude This knob is used to set Atrium pulse Amplitude in volts values It allows continuous adjustment of the amplitude from...

Страница 14: ...emaker It is defined by the 3 position NBG code as below 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 V S Single A V 5 2 6 Refractory Period A V The Refractory period is the interval during which a sensed event does not affect pacing timing The Ventrica...

Страница 15: ...of Ventricle Sensitivity Sensitivity is the ability of the pacemaker to see intrinsic cardiac events R Wave 5 2 9 Blanking Period Blanking is the period following a paced Atrial event for which Ventricle sense amplifier will be kept OFF Blanking period is fixed For Pace 125ms and for Sense 75ms 5 2 10 Rapid Atrial Rate Caution RAP is for atrial use only Be sure the leads are connected to the atriu...

Страница 16: ...ING INSTRUCTIONS _______________________________________________________________ 6 1 RAP Button Whenever Rapid Atrial Rate is required press the RAP button and adjust the rate knob for desired Atrial rate Caution Only for Atrial 6 2 ON Switch Switches the unit ON by pressing ON button ...

Страница 17: ...ng rotary switches To unlock the device press Pause button once then LOCK message will disappear and now parameters can be changed Press PAUSE switch to UNLOCK NOTE Please make sure after unlock all the parameters are at safe values as after unlock parameters will be set as per rotary switches position because as the rotary switch is rotated in LOCK condition then device will set values after UNLO...

Страница 18: ...OO DVI DDD VDD VVI VOO Urg 6 7 Urgent Mode For urgent mode setting turn mode selection knob clockwise to extreme right 6 8 Collet terminals Accepts External pacing leads ranging from 1 8 to 2 3 mm diameter 6 9 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 ...

Страница 19: ...ttery 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 of continuous operation a 9V alkaline battery will have a service life of approximately 166 hours 7 days on full battery Nominal Values Mode DDD Rate 70 BPM Amp A V 5 0V AVI 140 ms Sens ...

Страница 20: ...0 and 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 The atria and ventricular channels are continuously blanked When pacing in the VOO mode the pacemaker will pace the ventricle asyn...

Страница 21: ...etected atria activity The ventricular channel is continuously blanked When pacing in the VVI mode the pacemaker will pace the ventricle at the programmed base RATE in the absence of detected ventricular activity The atria channel is continuously blanked Dual Chamber Modes The Model Zeus 1 will pace in four dual chamber modes DOO DDD DVI VDD ...

Страница 22: ... the atrium and ventricle inhibits output stimuli Without atria events within certain periods the pacemaker delivers a pacing stimulus to the atrium at the end of the V A interval which is equal to the programmed base rate minus the programmed A V INTERVAL Without ventricular activity during certain periods the pacemaker delivers a pacing stimulus to the ventricle at the end of the programmed A V ...

Страница 23: ...thers acetone or chlorinated solvents as these may damage the case or labels Caution The Model Zeus 1 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 visibl...

Страница 24: ...ode 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 Zeus 1 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 stron...

Страница 25: ...lating 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 Connecting the Lead System The patient cable should be connected to the temporary pacemaker before the lead system is connected to the patient cable Turning the Dev...

Страница 26: ...nts 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 Pacetro...

Страница 27: ...failure Lead Systems Bipolar lead systems are recommended because they are less susceptible to electromagnetic interference Sensitivity Settings Since the sensitivity setting determines the smallest signal that can be sensed by the pacemaker set the sensitivity dial to at least one half the mV value of the patient s sensitivity threshold This will provide an adequate safety margin to ensure proper...

Страница 28: ... physical dimensions from that of the recommended batteries may result in erratic or no pacing output Inspect the contacts on the battery for visible signs of contamination prior to use Use of batteries with contamination on the contacts may result in erratic or no output Failure to ensure that the battery drawer is fully latched may result in a loss of power Unauthorized Changes of Pacemaker Sett...

Страница 29: ...hampur Dist Dhar M P 454775 Fax 07292 400418 Tel 07292 411105 Email pacetronix hotmail com Website www pacetronix com Notes _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ ...

Страница 30: ...r medical complications or other direct or consequential damages resulting from the use removal or replacement of any external pacemaker pursuant to this agreement or caused by any defect failure or malfunction of the same lead or adapter whether such claim for damages is based upon warranty negligence contract strict liability tort or otherwise 3 Disclaimer this limited one year warranty is in li...

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