Pacetronix ZEUS-1 User manual

DUAL CHAMBER
EXTERNAL PACEMAKER
Shree Pacetronix Ltd
Plot no. 15, sector II,
Pithampur, Dist.: Dhar
Madhya Pradesh, India
Email: pace[email protected]
Website: www.pacetronix.com

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

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

Contents
1. GENERAL DESCRIPTION................................................................................................. 6
2. PACKAGE CONTENTS ...................................................................................................... 8
3. SAFETY FEATURES........................................................................................................... 8
4. SPECIFICATION.................................................................................................................. 8
4.1 Technical Data ............................................................................................9
4.2 Mechanical Data .......................................................................................11
4.3 Urgent Values............................................................................................11
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 AVI (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 Demand and asynchronous Modes............................................................18
6.7 Urgent Mode..............................................................................................18
6.8 Collet terminals .........................................................................................18
6.9 Lead placement..........................................................................................18
6.10 Battery Replacement..................................................................................19

7. MODE DEFINITIONS ....................................................................................................... 20
8. DEVICE MAINTENANCE................................................................................................ 23
8.1. Cleaning.....................................................................................................23
8.2. Safety & Technical checks.........................................................................23
9WARNINGS......................................................................................................................... 23
10 PRECAUTIONS .............................................................................................................. 26
11 FURTHER INFORMATION......................................................................................... 29
12 LIMITED ONE YEAR WARRANTY........................................................................... 30
-------------------------------------------------------------------------------------------------------

1. GENERAL DESCRIPTION
_________________________________________________________________
The Zeus-1 Dual chamber external pacemaker offers short-term pacing to the patient
with myocardial infarction or heart block.
Note: In rest of the document Zeus-1 Dual chamber external pacemaker will be
referred as Zeus-1.
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 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 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.

ZEUS -1

2. PACKAGE CONTENTS
_________________________________________________________________
Zeus-1 Dual chamber external pacemaker.
One 9V alkaline battery.
Instruction / Technical manual.
Carrying case.
One Arm strap.
Note: Check the package prior to use.
3. SAFETY FEATURES
_________________________________________________________________
The Shree Pacetronix Model ‘ZEUS-1’ is designed to be reliable, simple to
operate, and comfortable to hold. Safety features of ZEUS-1 include:
•Low Battery indicator.
•Continuous operation during battery replacement.
The battery change over time is approx 15 sec..
•Rubber seal covering for box.
•Pacing/Sensing 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 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 Zeus-1 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 ‘PACE’ & Sensing is indicated by
synchronous flashing of ‘SENS’. Mains independence battery operation provides a maximum
on electric safety for both patient and user.
4.1 Technical Data
PARAMETERS VALUES
Technical Parameters
Description of
Pacemaker Dual chamber External Pacemaker
Rate 30 to 250 BPM (In steps of 2 BPM)
Upper Rate Base Rate + 30 BPM (Min 110 BPM)
Rapid Atrial Pacing 60 to 1000 BPM
Amplitude (A) 0.1 TO 18 Volts (at 510 Ωload)
Amplitude (V) 0.1 TO 18 Volts (at 510 Ωload)
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 hrs
Battery Chemistry Duracell 9V PP3 Alkaline battery
Polarity Bipolar
Indication
Pacing Indication :
Flashing RED LED’s on the front panel for both Atrial
& Ventricle.
Sense Indication :

Flashing 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

Lock / Unlock After 20 pacing/Sensing cycles device locked automatically.
Press “Pause” switch to ‘Unlock’
Safety Cover Acrylic transparent cover
Pause Button When pressed output will be stopped for at the most 10 sec.
ON/OFF Button Separate ON and OFF button 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 DOO
AV Delay 140 ms
Pulse Width (A/V) 1.0 ms / 1.5 ms

5. FUNCTION AND DESCRIPTION
_________________________________________________________________
5.1 Functional Indicators
5.1.1 Pacing
Pacing Indication :
Flashing LED’s on the front panel for both A & V.
Note : These LED’s indicate delivery of a pacing pulse
but do not necessarily indicate that the pacing pulse has
initiated cardiac stimulation.
5.1.2 Sensing
Sense Indication :
Flashing LED’s on 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 calibrated for the
Parameter displayed.
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.
Rate (ppm) = 60000/ Interval (ms)
5.2.2 AVI (mSec) (A-V Interval)
This knob is used to set different A-V intervals in ms. It
allows continuous adjustment of the A-V interval from 20
to 300 ms.
Description of A-V Interval :-- The set A-
V Delay
determines the time interval between an Atrial event (paced
or sensed) and 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 A
trium pulse Amplitude in volts
values. It allows continuous adjustment of the amplitude
from 0.1 to 18 Volts.
Description of Atrium Pulse Amplitude :--
It is the
electrical pressure that causes electric current to flow.
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

5.2.4 ‘A’ Sens (mV) (Atrium Sensitivity)
This knob is used to set Atrium sensitivity (mV) values. It
allows continuous adjustment of the Sensitivity from 0.4 to
10 mV.
Description of Atrium Sensitivity: Sensitivity is the ability
of the pacemaker to see intrinsic cardiac events (P Wave).
5.2.5 Mode
This knob is used to set desired Mode. AOO, AAI, DOO,
DVI, DDD, VDD, VVI , VOO and Urgent.
Description of Mode: This parameter
defines the
functionality of Pacemaker. 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 Ventrical
refractory period is fixed at appox. 250 ms. Knob is used
to set Atrial refractory period (ms). It allows continuous
adjustment of A Ref period from 150 to 500 ms. This is
PVARP (Post ventricle Atrial refractory period) for dual
chamber modes.

Description of Blanking period :Blanking
is the period
following a paced Atrial event for which Ventricle sense
amplifier will be kept ‘OFF’.
5.2.7 ‘V’ Output (Volts) (Ventricle Pulse Amplitude)
This knob is used to set Ventricle pulse Amplitude in volts
values. It allows continuous adjustment of t
he amplitude
from 0.1 to 18 Volts.
Description of Ventricle Pulse Amplitude:-- It is the
electrical pressure that causes electric current to flow.
5.2.8 ‘V’ Sens (mV) (Ventricle Sensitivity)
This knob is to select different Ventricle sensitivity values.
It allows continuous adjustment of the Sensitivity from 0.8
to 20 mV.
Description 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 atrium, not the
ventricle, before enabling RAP.
Rapid atrial rate is used to control Atrial fibrillation. Rapid atrial rate can be activated by
pressing RAP button located on front panel of the unit and by selecting from rate setting
knob.
Caution:
RAP may result in tachycardia, acceleration of existing tachycardia, or fibrillation.
Apply high rates under careful patient monitoring and control. Monitor the patient’s ECG and

blood pressure, and ensure defibrillation equipment is immediately available.
6.OPERATING 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.

6.3 OFF Switch
Switch the unit OFF by pressing OFF switch twice in 4 sec. Press and
held switch for 1 sec and then release and press again. If it doesn’t gets
OFF then repeat the process.
6.4 Pause / Unlock Button
Pause button is used to stop output of the unit for both chambers.
(When pressed and held the output stops for at the most 10 seconds). If
pause is required again after 10 seconds, then release button and press
again.
6.4.1 Device LOCK
Alternate function of this button is to unlock the device. The device
will go in LOCK mode after 20 pacing/sensing cycles if the device is
kept idle. The message “LOCK” will appear on the display along with
other parameters. After this parameters will not be changed even after
moving 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 UNLOCK it.
6.5 Knob Controls
The available parameter range is printed on the panel, e.g the “Rate
knob” ranges from 30 ppm to 250 ppm. Rotate the “knob” clockwise
or anticlockwise to increase or decrease the parameters value
respectively. Changed parameter value displayed on LCD screen
accordingly.
Note : Parameters will be displayed as per the modes.
‘Rate’ & ‘Pulse width’ will be displayed in all modes.
Modes
Parameter Displayed
Parameter not Displayed
AOO A-Amp V-Amp, V-sense, A-sense,
AVI,Aref
AAI A-Amp, A-sense,Aref V-Amp, V-sense, AVI

DOO A-Amp, V-Amp , AVI V-sense, A-sense,Aref
DVI A-Amp, V-Amp, AVI, V-sense A-sense
DDD A-Amp, V-Amp, AVI, A-sense, V-
sense,Aref -----
VDD V-Amp, A-sense, V-sense, Aref A-Amp, AVI,
VVI V-Amp, V-sense A-Amp, A-sense, AVI,Aref
VOO V-Amp A-Amp, V-sense, A-sense, AVI,
Aref
6.6 Demand and asynchronous Modes
Demand Modes available are AAI > DVI > DDD > VDD > VVI
Asynchronous Modes available AOO > DOO > VOO
Knobs turned clockwise select Mode starting from
AOO > AAI > DOO > 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 impaction, can be noted.
b). Connecting the lead to the ZEUS-1
Switch OFF the device (Zeus-1).
Connect the proximal electrode to the indifferent (+) red terminal and
the distal electrode to the active (-) black terminal of Temporary lead

and External pacemaker (Zeus-1) 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.
6.10Battery 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 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 (A/V) – 0.8mV/2.0mV
NOTE: We recommend having a spare battery all the times. The
battery should be removed if the device is placed in storage.
Battery replacement time is approx 15 seconds.

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.MODE DEFINITIONS
Single Chamber Modes
The Model Zeus-1 will pace in four single chamber modes: AOO, VOO, AAI, and VVI.
AOO and VOO Modes
The asynchronous mode (A00 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 asynchronously at the programmed base Rate.
AAI and VVI Modes
In the inhibited (or demand) modes (AAI and 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,