Pacetronix SMART-E PROGRAMMER User manual
SMART – E PROGRAMMER
USER MANUAL
Programming Interface
Model: SEP – 11
Programming Head
Model: SEH – 11
Shree Pacetronix Ltd.
Plot No. 15, Sector II,
Industrial Area,
Pithampur, Dist. Dhar
454775 (M.P.), INDIA
Telephone: 07292-411105
Fax: 07292-2762728
E-mail: [email protected]
Website: http://www.pacetronix.com
Revision
Date
Change Description
01
January 15
th
, 2017
IFU
02
August 25
th
, 2020
User Information
Explanation of Symbols
Serial
Number
Symbol Symbol Explanation
1.
Operating instructions
2.
Do not dispose of this product in the unsorted municipal waste
stream. Dispose of this product according to local regulations
3.
Product documentation
4.
DEFIBRILLATION-PROOF TYPE BF APPLIED PART.
5.
General warning sign
Contents
1. MANUAL CONTAINS.................................................................................5
2. GENERAL.....................................................................................................7
3. INTRODUCTION.........................................................................................9
4. TECHNICAL SERVICE..............................................................................9
5. CONNECTORS AND INDICATORS DESCRIPTION.........................10
5.1 Connections of Programming Interface.................................................10
5.2 Indicators on SMART-E Programming Head Model SEH-11...............11
6. SYSTEM REQUIREMENTS ....................................................................12
6.1 Installation..............................................................................................12
7. INSTRUCTION FOR USE ........................................................................12
8. SPL SOFTWARE SCREEN ......................................................................13
8.1 Use of the Mouse and Keyboard ............................................................13
8.2 Run SPL software...................................................................................14
8.3 SPL software Screen...............................................................................14
8.4 Actions....................................................................................................17
9. DATA – LOG BROWSER.........................................................................23
9.1 Implant....................................................................................................23
9.2 ECG........................................................................................................24
9.3 Reports....................................................................................................24
10.Tables............................................................................................................25
A). Parameter Values of SSI 8820 Pacemakers...............................................25
B). Parameter Values of SSIR 297 Pacemakers..............................................25
C). Parameter Values of DDDR 747R Pacemakers ........................................26
D). Parameter Values of Trinity 3000 Pacemakers.........................................28
E). Summary of Parameters in Charak-DDDR 747R & Trinity 3000.............29
F).SPL software statistical data for Pinnacle-R 297 & Pinnacle 8820 .........30
1. MANUAL CONTAINS
This manual explains the use of the SMART-E programmer for Pacemaker Model SEP-
11 with SPL software. It is divided in the following sections:
Introduction In this first section, the basic requirements, Connections,
indications and the SPL software installation procedure are
described. It is also indicated where to ask questions and find
solutions to problems that cannot be solved through the manual.
NOTE: In this manual the SMART-E programmer for
Pacemaker Model SEP-11 will be referred as SMART-E
Programmer Model SEP-11 in rest of the document.
SPL software Screen This section is directed mainly to those users who do not have
previous experience in the use of a personal computer that runs
Windows XP or Windows 98 operating system. It defines the terms
used throughout the manual and explains the usual working
procedures in Windows starting from a detailed description of the
SPL software screen.
Actions In this section the operations of interaction with the pacemaker that
can be carried out with SPL software, as how to obtain information
from the pacemaker and how to program it, are described.
Data The handling of the stored information by SPL software database,
the way of browsing in or modifying this information, and the
transference to other applications, whenever necessary, are
described here.
Tables Tables with the values of the different programmable parameters
according to the pacemaker model are annexed at the end of the
manual.
2. GENERAL
SMART-E Programmer includes Programming interface Model SEP-11, Programming
head SEH-11, USB cable & ECG cable. Programmer is a device used for programming
of the pacemaker with the help of PC/Laptop.
SMART-E Programmer Model SEP-11 is connected by means of an interface to a
laptop/PC, which communicates by telemetry to the pacemaker implanted in the patient.
The SMART-E programming head Model SEH-11 must be placed over the implant zone,
making sure that the light blinks following its frequency. The programming head
strength is such that it can communicate with pacemaker when it is kept within air gap of
50 mm height. The button located in the programming head is usually used to
"interrogate" the pacemaker, that is, the programmed values that determine its
functioning.
Using SMART-E Programmer Model SEP-11 the Physician may interact with the
pacemaker: modify the frequency and duration of the generated stimulus, measure
pacing and sensitivity thresholds, study statistics and graphics of the assistance given by
the heart stimulator, keep an electronic file of patients and their controls, print reports,
calculate which is the battery consumption of each program, register standard programs
for further use, reprogram the pacemaker in order to quickly control heart rhythm
problems, etc.
Accessories
•Programming Interface Model SEP-11
•Programming Head Model SEH-11
•USB Cable
•ECG Cable
Characteristics
•Weight -
800 gms. (Including Programming Head Model SEH-11,USB & ECG cable)
•Dimensions
¬Programming Interface Model SEP-11 : 150 x 200 x 40 mm (L * W * H)
¬Programming Head Model SEH-11: 140 x 62.7 x 30.5mm (L * W * H)
•Supply voltage, power –
USB powered (5.0Volts DC)
IP Classification
•SMART-E Programmer Model SEP-11 ---- IP40
•SMART-E Programming Head Model SEH-11 ---- IP41
Conditions of Storage & Transportation
•Handle with care, storage temp 0 to 40°C.
Maintenance Conditions
•Not water proof, for any defects return back to the company.
Limited One Year Warranty
1. Limited Warranty and Replacement Agreement: SHREE PACETRONIX LTD.
Provides assurance that if the SMART - E should fail to function within its specified
tolerances within one year from date of purchase, due to faulty workmanship or a
defective component excluding the battery, the Company will replace all components and
provide service free of charge.
2. Limitation of Liability, Shree Pacetronix Ltd. shall not be liable for any medical
expenses, adverse body reactions, or medical complications or other direct or
consequential damages resulting from the use of SMART-E Programmer Model SEP-11
pursuant to this agreement or caused by any defect, failure or malfunction of the same,
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 lieu of all other warranties expressed or
implied. Pacetronix specifically disclaims any implied warrantee of merchantability or
fitness for a particular purpose. The remedies set forth herein shall be the exclusive
remedies available arising out of the sale or use of the SMART - E. No person has any
authority to bind Shree Pacetronix Ltd. to any representation or warranty except as set
forth herein.
3. INTRODUCTION
Welcome to SMART-E programming system with SPL software, the application
designed by Pacetronix to consult and modify the parameters that rule pacemaker
activity belonging to their SSI / SSIR / DDD / DDDR / Bi-Ventricular pacemakers.
SPL software, created to be run in a personal computer with Windows XP or Windows
98 operating system, is connected by means of a programming interface to a small
SMART-E Programming Head Model SEH-11, which communicates by telemetry to the
pacemaker implanted in the patient.
The SMART-E Programming Head Model SEH-11 must be placed over the implant
zone, making sure that the light blinks following its frequency. The SMART-E
Programming Head Model SEH-11 strength is such that it can communicate with
pacemaker when it is kept within air gap of 50 mm height. The button located in the
SMART-E Programming Head Model SEH-11 is usually used to "interrogate" the
pacemaker, that is, to show in the SPL software screen the programmed values that
determine it’s functioning.
Using SMART-E Programmer Model SEP-11 with SPL software the Physician may
interact with the pacemaker: modify the frequency and duration of the generated
stimulus, measure pacing and sensitivity thresholds, study statistics and graphics of the
assistance given by the heart stimulator, keep an electronic file of patients and their
controls, calculate which is the battery consumption of each program, register standard
programs for further use, reprogram the pacemaker in order to quickly control heart
rhythm problems, etc.
SPL software offers in a graphic interface of quick and easy handling, all these multiple
options which improve the functioning of the pacemakers built by Pacetronix and
achieve, in every case, accurate and personalized clinical follow-up.
4. TECHNICAL SERVICE
ln case of additional help about SMART-E Programmer Model SEP-11, SPL software or
about SSI / SSIR / DDD / DDDR / Bi-Ventricular pacemaker series you may consult
Pacetronix through:
Mail: Plot No.15, Sector-II, Pithampur, Dist. Dhar (M.P.) 454775, INDIA
Telephone: 07292-411105
Fax: 07292-2762728
E-mail: pacetronix@hotmail.com
Web: www.pacetronix.com
5. CONNECTORS AND INDICATORS DESCRIPTION
Rear View of SMART-E interface
5.1Connections of Programming Interface
i. USB Cable Connection:
•To PC
Connect USB cable PC end to USB port of the PC to connect programming
interface with the PC to powering up the SMART-E Programmer Model SEP-
11 system.
•To SMART-E Programmer Model SEP-11
Connect USB cable Interface end to programming interface female connector
USB I/O.
Make sure the connection of USB cable from both PC and Interface end.
ii. SMART-E Programming Head Model SEH-11 connection
Connect SMART-E Programming Head Model SEH-11 male connector to
programming interface at Female connector SMART-E PROGRAMMING
HEAD MODEL SEH-11.
iii. ECG Cable connection
•At SMART-E Programmer Model SEP-11 end
Connect ECG cable male circular connector to the programming interface
female ECG connector.
•At patient end
Connect ECG cable patient end electrode connectors to the patient by using
disposable electrodes.
Note: - Make sure that patient’s body should be cleaned first before placing
disposable electrodes.
5.2Indicators on SMART-E Programming Head Model SEH-11
I. Power-up indicator
Power-up indicator is placed on the SMART-E Programming Head Model
SEH-11. When SMART-E Programmer Model SEP-11 powered-up by USB
port of the PC, a green LED on LED bar glows, and indicating power-up of
SMART-E Programmer Model SEP-11.
II. Signal Strength Indicator
LED bar placed on the SMART-E Programming Head Model SEH-11
indicates the telemetry signal strength when in contact with the programmable
pacemaker.
Signal strength is divided in 3 parts.
1. Green LEDs- Good signal strength
2. Yellow LEDs-Mid range of signal strength
3. Red LEDs- Poor signal strength
6. SYSTEM REQUIREMENTS
To install SPL software in a personal computer/Laptop, it must run Windows XP or
Windows 98 operating system. The basic characteristics of the required hardware are
the following:
•486 processor or more (Pentium recommended)
•RAM of 16 Mbytes
•8.0 Mbytes of free space in the hard disk
•Programming Interface supplied by Pacetronix connected to the equipment.
Even if it is not strictly necessary to use a mouse to run the program, for all functions
can be commanded from the keyboard, it is highly recommended to have one in order
to handle it more comfortably.
6.1Installation
To install SPL software verify that the computer fulfills the basic requirements
indicated above and insert the CD labeled SPL software into your CD-ROM drive.
Double click the ” setup “ file in the folder. Once the Auto Run Installation program
begins just follow the instructions.
The notebooks supplied by Pacetronix have SPL software preinstalled; in this case the
installation is not necessary.
7. INSTRUCTION FOR USE
1. Please ensure before use that SMART-E Programmer Model SEP-11 should contain
I. Programming Interface
II. SMART-E Programming Head Model SEH-11
III. USB cable
IV. ECG cable (If required)
2. Connect USB cable’s USB end to USB port of the PC/Laptop.
3. Connect USB cable’s interface end to USB I/O of programming interface.
4. Connect SMART-E Programming Head Model SEH-11 to programming interface
SMART-E Programming Head Model SEH-11 female connector.
5. Please ensure that a green LED glowing on the SMART-E Programming Head Model
SEH-11 .
6. Now place SMART-E Programming Head Model SEH-11 on to implantable device
(Pacemaker) site on the patient.
7. Please ensure that LED’s are blinking on LED bar on the SMART-E Programming
Head Model SEH-11.
8. For proper telemetry ensure that green LED’s should blink. The SMART-E
Programming Head Model SEH-11 must be placed over the implant zone, making
sure that the light blinks following its frequency. The SMART-E Programming Head
Model SEH-11 strength is such that it can communicate with pacemaker when it is
kept within air gap of 50 mm height.
9. Positioning LED: It allows the easy detection of the right position of the SMART-E
Programming Head Model SEH-11 over the pacemaker
10. Maximum programming time is 500ms.
11. Interrogation of pacemaker parameters can be done by using interrogate switch on the
SMART-E Programming Head Model SEH-11 or by using mouse/keyboard with SPL
programming software.
12. Programming of pacemaker parameters can be done by SPL software.
13. For detailed programming instruction please refer to Actions in this manual.
8. SPL SOFTWARE SCREEN
This section describes the general characteristics of the SPL software Screen and
Windows XP / 98, the built in operating system, as well as some conventions applied
throughout this manual. If the procedures for using Windows are already known, a jump
over this section is advisable.
8.1Use of the Mouse and Keyboard
Windows XP / 98 is a graphical user interface in which programs are executed in
rectangular zones of the screen called windows. In all of them, the actions are carried
out pressing buttons or choosing the commands grouped in lists called menus, so the
user does not need to key in complicated instructions from the keyboard to be able to
run them. Windows XP / 98 is operated, in general, through the movements produced by
a mouse, translated into similar movements of a pointer in the screen. This manual
indicates the following procedures to be carried out with the mouse:
Point Position the mouse pointer until the tip of the pointer rests on the
indicated object.
Click Press and immediately release the left button without moving the mouse.
Double click Press and release the left button of the mouse twice in rapid succession.
Drag Press and hold down the left button while you move the mouse; then
release the button.
Select Point and click.
In some cases, the actions executed using the mouse, can also be carried out using the
keyboard by pressing different keys combinations called keyboard shortcuts. For
example: when the computer is turned on, a screen called Windows XP / 98 Desktop, in
which the Start button is seen in the left lower part, appears. In order to display the
Start Menu, you can click on the button with the mouse, or press at the same time
<Control> and <Esc> keys (as a keyboard shortcut).
8.2Run SPL software
If the PROGRAMS option of the Start Menu is selected, the different available
applications of the computer will be displayed. As it can be seen on the figure, once SPL
software is installed an option with this name and icon appears.
If the option SPL software is not found it means that the application has been installed
within a program group, then all the folders of the option PROGRAMS have to be
searched using the mouse until SPL software is found in one of them.
The program is activated clicking on the SPL software icon.
8.3SPL software Screen
SPL software occupies the entire screen with the exception of a Task Bar in which the
Start button is found. This particular status of the window is known as maximized.
SPL software Screen shows the following parts:
Title bar
It appears in the upper part of the window. It shows the icon, the name of the
program, and the pacemaker model being used.
♦Title bar of SPL software
In the right side, three buttons that allow changing the window status appear:
Minimizes the size of the window reducing it to a button in the Task Bar.
Clicking again on the button restores the previous size. The program is still open
in the minimized window but it is not possible to work on it.
Reduces the maximized window to a minor size. In this status the window can be
moved throughout the screen (dragging it from the title bar) and its size can be
modified (moving the pointer up to the borders until it becomes a double arrow,
and dragging it).
Notice that the button changes automatically to
to allow the window to be maximized again. The change from maximized to
normal or vice versa, can be also done by clicking twice on any of the empty
parts of the title bar.
Closes the window and exits from SPL software.
Toolbar
It is located under the menu bar and has several buttons which allow a fast access to
some commands:
Interrogate button: allows reading the information of the pacemaker. In order
to make a successful interrogation, the interface must be on, correctly
connected to the computer and must have enough battery. Besides, it should be
verified that the lighin the SMART-E Programming Head Model SEH-11 is
blinking when it is located in the implant zone, indicating that the distance to
the pacemaker is correct.
Program button: allows programming the pacemaker with the parameters
displayed on the screen.
Temporary Programming this button allows a temporary programming
mode in which the pacemaker paces with a high rate in Asynchronous mode.
The temporary programming mode ends when the SMART-E Programming
Head Model SEH-11 is moved away from the chest of the patient.
Marker button: This button puts the pacemaker in marker mode. Marks are
obtained which indicates the activity of the heart (paced or sensed events).
Threshold button: displays a menu in which the pacing or sensing threshold
to be determined are chosen. The pacing threshold corresponds to the
minimum energy of a stimulus generated by the pacemaker able to provoke an
effective heart contraction.
The sensing threshold is the minimum wave amplitude, generated by the heart,
able to be detected by the pacemaker.
Statistics button: it allows reading the statistic values stored by the
pacemaker, such as stimulus generated, sensed events, etc. The information is
shown in absolute numbers, in percentages, or by means of bar graphics.
Impedance button: This button allows measuring the lead impedance.
Longitivity calculation of pacemaker at different parameters setting.
Status Bar
It is located in the lower part of the SPL software Screen. It indicates the activity that
the program is carrying on (interrogating, programming, etc.). The status bar also
provides help, giving a clear and concise definition of any menu option or button
pointed with the mouse or the arrows.
In the right part of the Status bar there are three boxes that indicate if the lock keys in
the keyboard have been activated.
CAPS -The first box indicates if the key <Caps Lock> has been activated; any key from the
keyboard appears as a capital letter on the screen.
NUM - In the second box, NUM appears if the key <Num Lock> that changes the
functioning of the numeric keyboard, is pressed: if it is activated, numbers are
written from there, otherwise those keys act as scroll arrows.
Dialog boxes
Many times, when commands from the menus or from the buttons of the toolbar are
run, dialog boxes appear adding information and allowing to change the parameters of
the current action. For example: when running the command PRINT from the menu, a
dialog box appears, allowing the input of information about the pacemaker and the
patient to be stored.
Fig: PRINT DIALOG BOX
Dialog boxes include buttons, some of them open other dialog boxes, while accept (OK) and
Cancel buttons are generally used to run or ignore the command with all the marked options.
Finally the dialog boxes as the windows, have a title bar, from which they can be dragged
throughout the screen. However they have, as a difference, a fixed size that cannot be
changed.
8.4Actions
In this section the options of the Actions, Models and Standards menus are detailed. In
these menus the commands related to the consulting and programming operations of
pacemaker are grouped.
Interrogate
The first action to be carried out in order to access the information of the pacemaker is
Interrogate. After interrogating, the model, serial number, battery condition, and the
different programmable parameters are shown on the screen.
Once the SMART-E Programming Head Model SEH-11 is placed over the implant
zone, the leds blink on the LED bar of head and the interrogation action can be
performed in any of the following different ways.
1. Press the button in the SMART-E Programming Head Model SEH-11.
2. Click on the Interrogate button of the toolbar.
3. Activate the Tool menu and choose the INTERROGATE option.
If an error occurs, check the following: maybe the SMART-E Programming Head
Model SEH-11 is more than 50 mm (air gap) far from the pacemaker (no blinking
light); maybe the interface is off or it is not connected. Correct the situation and retry
by clicking on the Retry button of the message box.
If the interrogation is successful, the different parameters of the pacemaker (which
vary according to the model) appear on the screen (programming screen)
Some of the parameters are just informative and cannot be modified. They are:
Model: The pacemaker model appears in the title bar
Serial :The pacemaker serial number
Battery status: Battery Status of Pacemaker
If it is necessary to immediately transmit a safe set of values to the pacemaker,
the Urgent programming button on the toolbar, or the <F4> key on the keyboard can
be used. Bear in mind that the <F4> key may be pressed anytime, even having dialog
boxes opened in the SPL software Windows screen.
Each model has its own screen in which the programmable parameters appear. The
detailed list of the parameters and their allowed values of each model, are included at
the end of this Manual.
It is possible that the values of related parameters become inconsistent. In those cases,
SPL software will show an error message explaining the conflict situation.
♦Error message
To replace previous values with the new ones, selecte value from corresponding dialog
box. In order to roll back the changes, the Cancel button in the screen should be
pressed.Parameter modification in SPL software does not imply pacemaker programming.
To program the pacemaker, you should proceed according to what is detailed under
Programming title.
Programming
The Programming action transmits the values that are in the screen to the pacemaker
using telemetry. The SMART-E Programming Head Model SEH-11 should be
correctly placed on the implant zone (the green LED must blink).
Programming can be performed in any of the following ways:
1. Click on the Programming button in the toolbar.
2. Click on the Actions menu and then choose the PROGRAMMING option.
If the programming action was performed successfully, the message "Programming
OK" will appear, otherwise an error message box will be shown. In this case, in order
to repeat the action, you can click the Retry Button or type <Enter> or press the
SMART-E Programming Head Model SEH-11 button. On the other side, <Esc> key
and the Cancel button will cancel the action.
Marker Mode
This button puts the pacemaker in marker mode. Marker mode shows the status of the
pacemaker whether it is pacing or sensing the sinus rhythm. Pulse interval and count
also visible on the screen. If an electrocardiograph cable is connected to the interface,
ECG signals obtained which indicates the activity of heart (paced or sensed events)
Thresholds
One of the main functions that improve the pacemaker activity enlarging its life
length and allowing that, at the same time, spontaneous heart signals are sensed, is the
determination of pacing and sensing thresholds.
This manual suits for next models
2
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