ela medical Orchestra Users Guide

Meaning of the symbols that appear on the hardware

This symbol is used to encourage you to consult the documentation and manuals enclosed in the carrying case. This symbol indicates that the device is in full conformity with European Directive 90/385/CEE. (CE: Conformité Européenne).

IEC601 Class 1

This symbol indicates that this is BF Type equipment, protected against defibrillation shocks according to standard IEC601-1 for electrical medical equipment. This symbol indicates Underwriters Laboratories classification as follows: Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1 and CAN/CSA C22.2 NO. 601.1

Symbol used in the manual

This icon is used to call your attention to a particularly important point.

Precautions for use... i Service conditions ... ii Chapter 1 - Presentation of the Orchestra programmer ...1 1.1 Description ...1 1.2 Presentation of the system components ...2 Chapter 2 - Before using / shutting down the programmer ...5 2.1 Before using ...5 2.2 Starting the programmer...7 2.3 Shutting down the programmer ...7 2.4 Operating instructions ...8 Chapter 3 - Programming head...9 3.1 General information...9 3.2 Description of the head ...9 Chapter 4 - ECG: Connecting the electrodes...10 Chapter 5 - Printer ...11 5.1 Installing the printer paper ...12 5.2 Printer key: Paper advance key ...13 5.3 Removing a printout ...13 Chapter 6 - Maintenance...14 6.1 Component maintenance ...14 Chapter 7 - Technical data ...15

PRECAUTIONS FOR USE When designing and manufacturing devices, ELA Medical takes the influence of environmental factors into account in order to minimize the risks of deterioration during normal use. However, certain precautions should be taken in order to ensure that the programmer operates optimally. In fact, electronic devices are sensitive to a number of environmental factors that can alter their operation, such as: n An impact or rough handling, damaging the outside of the device.

This type of handling may have an effect on the proper operation of the programmer. Even if the device seems to be operating well after the impact, damage that is not immediately detectable may subsequently be revealed. n Spilling liquid on the device. When designing and manufacturing

the device, every precaution is taken to minimize the risks of infiltration. However, any liquid penetration would alter its operation. n Electrostatic discharge. Be sure to eliminate any static charge from

your body before touching the device when you are in an environment at risk for electrostatic discharge (carpeted floors, etc.). In order to do so, touch a hot water heater, a water line, gas line, etc. or, if none is available, a large metal object (operating table, etc.). n Prolonged storage in high humidity may damage the programmer.

Several other environmental factors may have an effect on the proper operation of the device in a hospital environment. Note

If you suspect that there has been any damage to your programmer, contact your ELA Medical representative.

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SERVICE CONDITIONS

n ELA Medical provides programming equipment that is compatible

with ELA Medical implantable pacemakers and ICDs. n ELA Medical agrees to replace any defective material.

Note

If a problem persists, contact our service department. Never modify the configuration of the ELA Medical programmer; do not install any software on this computer. ELA Medical waives all responsibility if a malfunction occurs following this type of manipulation. The programmer contains no internal parts that can be repaired by the user. In case of problems, please return it to your ELA Medical representative in the state it was received.

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CHAPTER 1 - PRESENTATION OF THE ORCHESTRA PROGRAMMER

1.1 Description The programmer is a portable device, equipped with a microprocessor used to program ELA Medical pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients. The rapidity of the microprocessor’s execution and data acquisition make the programmer an instrument appropriate for monitoring implant patients.

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1 - PRESENTATION OF THE ORCHESTRA PROGRAMMER

1.2 Presentation of the system components

Microphone

Speaker Display screen

On / Off key Power indicator Paper advance key

Screen brightness adjustment keys

Pointer stylus

PCMCIA drive

Emergency key Disk drive

Function of the components

Pointer stylus – Component used to select the programmer options that appear on the screen. By pointing to the screen at the desired location with the tip of the stylus, you activate the option of your choice. In order not to deteriorate the touch screen, ELA Medical recommends using only the stylus for making selections. Display screen – Flat, active-matrix touch screen providing good readability from all angles, with possibility of opening up to 130°. The programmer options are selected directly on the screen using the stylus. On / Off key – Key that starts / stops the programmer. Power indicator – Programmer power indicator: n orange when the programmer power is turned on and is on standby n green when the programmer is operating

Emergency key – Used to program the nominal mode (see implant manual).

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1 - PRESENTATION OF THE ORCHESTRA PROGRAMMER

Screen brightness adjustment keys: n left to decrease the brightness of the screen n right to increase it

Paper advance key – Used to advance the paper selectively or page by page (see Chapter 5). Disk drive – This drive provides the possibility of loading and/or storing patient data on 3.5” diskettes. PCMCIA drive – As client applications that use this port become available, specific instructions will be provided.

Equipotential mass connector

Storage compartment

Programming head

ECG cable I/O ports Power cable

Function of the components

Storage compartment – Compartment located at the rear of the programmer, where components are stored. ECG cable – Connection cable between the programmer and the electrodes placed on the patient. Programming head – Provides communication between the programmer and the implant. It must be positioned above the pacemaker or defibrillator during programming or interrogation procedures (see Chapter 3).

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1 - PRESENTATION OF THE ORCHESTRA PROGRAMMER

Equipotential mass connector – For certain applications, allows various devices to be interconnected so that the reference potential is the same. Power cable – Cable that connects the programmer to the power supply. I/O ports (parallel, serial, Ethernet network, modem, RS 232) – These different ports were designed for future updgrades. As client applications for the different ports become available, specific instructions will be provided in the software user guides. Note

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Regarding the parallel port: It is possible to install an external printer via the external parallel connector. In that event, you should contact your ELA Medical representative for installation of the proper driver.

Chapter 2 - BEFORE USING / SHUTTING DOWN THE PROGRAMMER

In this chapter, you will find all of the basic information necessary for using the programmer, such as: n setting up the programmer n starting the programmer n shutting down the programmer

2.1 Before using Before using, perform the following steps:

Step 1: Installation The work environment is an essential element. In fact, inappropriate installation of the equipment may interfere with its use. Consequently, in order to ensure the proper operation of the programmer, you should place it on a desk or table close to the power source.

Step 2: Opening the storage compartment n Press the latch of the back storage compartment and lift it. n Remove the various components from the storage compartment.

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2 – BEFORE USING / SHUTTING DOWN THE PROGRAMMER

Step 3: Connecting the programming head (initial use) Connect the programming head cable to the proper connector (Œ) located inside the storage compartment as shown in the figure below:

•

Œ

Notch in the storage compartment

Step 4: Connecting the ECG cable (initial use) Connect the ECG cable to the proper connector inside the storage compartment (•) (see figure above).

Step 5: Power supply to the programmer The electrical connection is made using the single receptacle located on the back of the programmer: n Insert the female plug of the power cord into the programmer

connector. n Connect the other end to an AC power receptacle.

The orange power indicator on the programmer lights up.

Step 6: Closing the storage compartment Pass the connector cables (programming head and ECG) through the notch in the storage compartment in order to close it without interference.

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2 - BEFORE USING / SHUTTING DOWN THE PROGRAMMER Note

In general, steps 3 and 5 should be done before using the programmer for the first time. You can store the components in the storage compartment, leaving the ECG and programming head cables connected.

Step 7: Opening and positioning the screen n Pull the latches located on each side of the programmer to release

the screen. n Lift the screen and position it at your convenience.

The programmer keyboard is now accessible.

2.2 Starting the programmer n Be sure to do the various steps described above before using. n Press an hold the On / Off key (orange key on the programmer

keyboard). The power indicator on the programmer turns green. The welcome window is displayed on the screen. Note

The software boots automatically when the programmer starts up.

2.3 Shutting down the programmer Press the On / Off key on the programmer (orange key on the keyboard) and hold it down for 1 second. After a few moments the power indicator on the programmer turns orange; the programmer is shut down. There is a guard around the On / Off key to avoid a cutoff due to an error in handling. Note

Completely folding down the screen for a few minutes while the programmer is in operating mode automatically causes the screen to be turned off.

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2 – BEFORE USING / SHUTTING DOWN THE PROGRAMMER

2.4 Operating instructions Place the stylus in its compartment before folding down the screen. Be sure the programmer is shut down before you unplug it; the power indicator should be orange.

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Chapter 3 - PROGRAMMING HEAD 3.1 General information n An automatic test is run when the head is turned on in order to

verify that it is operating properly (the blinking red indicator shows that this test is running). n There is no magnet in the head. However, it may temporarily

disturb the rate response function during interrogation.

3.2 Description of the head CPR2 programming head

The programming head is automatically switched ON at the first telemetry action such as parameter interrogation. The head is automatically deactivated when the dedicated programmer is switched OFF. The programming head has one button and two indicator lights: n The “+” or “Nom.” button reprograms the device to nominal

parameters. It allows emergency reprogramming as soon as the dedicated programmer is switched ON. n The green light indicates that the head is active. n The red light flashes during the auto test of the programming head.

It is switched ON temporarily in order to confirm conversion to the nominal mode. The programming head is directly power supplied by the dedicated programmer. The operation of the programming head can be disturbed by an electrostatic discharge. This phenomenon does not last and does not change the transmitted data. Dimensions: 12cm x 10cm x 5cm Weight: 325 g Note

The serial number of the head and the model are indicated at the rear of programming head. The programming head cannot be sterilized. While the device is being implanted, the programming head must be completely covered by a sterile cloth or sheath before any application to the patient.

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Chapter 4 - ECG: CONNECTING THE ELECTRODES Step 1: Placing the electrodes on the patient n Clean the skin at the points of contact. n Use special ECG gel in order to improve the signal conduction

between the skin and the electrodes. n Place the four standard electrodes on the patient.

Step 2: Attaching the leads to the electrodes Connect each colored wire to one of the electrodes as follows: Lead wire

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Position

Black

Left arm

Red

Left leg

Green

Right leg

White

Right arm

Chapter 5 - PRINTER

The printer uses thermal paper supplied by ELA Medical. The reams of paper are in the form of rectangular tablets. Each tablet is composed of a set of precut sheets. Paper features

Each sheet of paper has: n one glossy side on which there is a black rectangle (or marker) and

the paper reference n a matte side

Note

A red strip printed on the edge of the paper indicates that the tablet of paper is nearly finished.

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5 - PRINTER

5.1 Installing the printer paper The paper can feed only when the programmer is on.

Step 1: Installing the paper n Open the paper access compartment located on the rear left side of

the programmer and position yourself facing the printer. n If necessary, remove the paper remaining in the compartment. n Unfold the first sheet of the new tablet of paper. n Using both hands, place the sheet under the printer roller and

insert it until it advances automatically.

Note

During insertion, center the sheet so that the alignment is correct. n Insert the tablet of paper into the compartment. n Check that the paper covers the printer roller. n Close the printer cover.

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5 - PRINTER

Step 2: Aligning the paper After installing the paper, the sheet alignment may not be correct. To remedy this, do the following procedure: n Open the storage compartment. n Place the blue latch that unlocks the printer in a vertical position. n Using both hands, align the sheet. n Lower the blue latch. n Advance the paper with the button on the keyboard.

5.2 Printer key: Paper advance key The paper advance key is located on the programmer keyboard and allows the paper to be advanced: n little by little, by pressing the key repeatedly n sheet by sheet, by holding the paper feed key down for a second

5.3 Removing a printout n Press the paper advance key hold it down for one second so that

the paper is automatically positioned at the precut line. n Grasp the paper and pull it to one side.

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Chapter 6 – MAINTENANCE

The purpose of this chapter is to provide the programmer’s various maintenance instructions. In addition to these instructions, the different features of the programmer components are described.

6.1 Component maintenance All of the tasks relative to programmer maintenance consist of: n cleaning the outer surfaces and certain components, n installing paper in the printer when needed.

The programming system does not require any other specific maintenance.

Cleaning the system components The various programmer components as well as the outer surfaces may be cleaned using a soft cloth. Avoid dropping any liquid on the programmer. In addition, the programmer and its components should never be immersed in any liquid or cleaned with sterilization products.

Sterilization You cannot sterilize the programming head, but you can wrap it in a sterile cloth, if necessary.

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Chapter 7 - TECHNICAL DATA Conformity of the programmer Conformity with the Directive

EN 90/385

Patient safety

NF EN 60 601-1, Class I, BF Type.

EMI

IEC 1000-1, -2, -3, -4, -5.

Power supply Voltage

100 to 230 V

Frequency

50 - 60 Hz

Printer Type

Thermal printer, print width: 104 mm

Print speed

Up to 50 mm per second

Type of paper

ELA Medical thermal paper, part no.: XRA 100 accordion fold; width: 112 mm.

ECG specifications Available channels

I, II, III

Band width

0.5 to 150 Hz

Linear range of ECG use

15 mV peak to peak

Defibrillation protection

5 kV, according to EN 60 601-1 § 17h and ANSIA/AAMI ES1 and EC 38

Recovery time after defibrillation shock

<5s

ECG offset range

<1V

Input impedence

10 MΩ

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