PACE 203 Technical Manual 5I-17-013-B-18

Technical Manual

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Technical Manual

PACE 203 External Dual Chamber Pacemaker

Manufacturer Osypka Medical GmbH Albert-Einstein-Strasse 3 D-12489 Berlin, Germany Phone: +49 (30) 6392 8300 Fax: +49 (30) 6392 8301 E-Mail: [email protected]

5I-17-013X-B-18

Osypka Medical 2013©

Osypka Medical PACE 203 – Technical Manual

Table of Contents 1 Technical Description 1.1 Overview 1.2 Classifications 1.3 Applicable Standards 1.4 Electronic Block Diagram 1.5 Mechanics

6 6 6 6 7 8

Function Check

3 Safety Check 3.1 Micro/Macro Shock Protection Tests 3.1.1 Measurement of Enclosure Leakage Current 3.1.2 Measurement of Patient Leakage Current 3.1.3 Insulation Test 3.2 Measurement of Patient Auxiliary Current 3.3 Runaway Protection Test

10 11 12 12 14 14 15

4 Special Service Modes 4.1 Service Mode 4.1.1 Activation of Service Mode 4.1.2 Deactivation of Service Mode 4.1.3 Service Menu

16 16 16 16 16

5 Feature and Compatibility Menu 5.1 Activation of the Feature and Compatibility Menu 5.2 Deactivation of the Feature and Compatibility Menu 5.3 Hardware & Software Compatibility Issues 5.3.1 Firmware 1.29 or higher 5.3.2 Firmware 1.25 + 1.26 + 1.27 + 1.28 5.3.3 Firmware 1.24 5.3.4 Firmware 1.23 5.3.5 Firmware 1.22 5.3.6 Firmware 1.21.1 5.3.7 Firmware 1.21 + 1.20 5.4 LCD Board Generations

17 17 17 17 18 19 19 20 20 21 21 22

6 Pulse Generator Timing 6.1 General 6.1.1 Terms 6.1.2 Symbols 6.2 Mode Characteristics 6.3 Asynchronous modes (V00 or A00) 6.4 Inhibited Single-chamber Modes (VVI or AAI) 6.5 Asynchronous Dual-chamber Mode (D00) 6.6 Dual-chamber Mode without Atrial Stimulation (VDD) 6.7 Dual-Chamber Universal Mode (DDD) 6.8 The Implicitly Adjustable DAI Mode 6.9 The Implicitly Adjustable DVI Mode 6.10 Atrial Trigger Modes (AAT, DDD+AT)

23 23 23 24 24 25 25 26 26 27 28 28 29

EMC Guidance and Manufacturer’s Declaration

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7.1 7.2 7.3 7.4

Electromagnetic Emission/Radiation Electromagnetic Immunity Electromagnetic Immunity for External Cardiac Pacemakers Recommended Safety Distances to Portable and Mobile RF Equipment

8 Appendices 8.1 Error Codes 8.2 Stimulation Amplitude According to ISO Definition 8.3 Waveform of Stimulation Pulse 8.4 Sensitivity for sin² Test Impulses 8.5 Spare Part List 8.6 Circuit Diagrams and Assembly Drawings TM 8.7 Function and Safety Check with SigmaPace 1000 8.7.1 Visual Inspection 8.7.2 Test Equipment & Test Set Up 8.7.3 Supply Current & Power Management 8.7.4 Patient Auxiliary Current 8.7.5 Runaway Protection 8.7.6 Pulse Amplitude 8.7.7 Pulse Duration 8.7.8 Rate 8.7.9 Sensitivity 8.7.10 Noise Detection 8.7.11 A-V Delay 8.7.12 Refractory Period 8.7.13 Electrode Supervisory 8.7.14 Cross Current 8.7.15 CTRL OUT Signal (optional) 8.7.16 Test Protocol

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30 31 32 33 34 34 37 38 39 40 42 52 52 53 53 55 55 56 56 56 57 57 58 58 59 59 59 60

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Table of Tables Table 1: Medical Device Classifications .............................................................................................................6 Table 2: Applicable Standards ............................................................................................................................6 Table 3 Leakage currents ................................................................................................................................ 11 Table 4 Insulation to be tested ........................................................................................................................ 12 Table 5 Runaway protection values ................................................................................................................ 15 Table 6 Hardware Compatibility Matrix for Firmware 1.29 or higher. .............................................................. 18 Table 7 Hardware Compatibility Matrix for Firmware 1.25, 1.26, 1.27 and 1.28. ............................................ 19 Table 8 Hardware Compatibility Matrix for Firmware 1.24. ............................................................................. 19 Table 9 Hardware Compatibility Matrix for Firmware 1.23. ............................................................................. 20 Table 10 Hardware Compatibility Matrix for Firmware 1.22. ........................................................................... 20 Table 11 Hardware Compatibility Matrix for Firmware 1.21.1. ........................................................................ 21 Table 12 Hardware Compatibility Matrix for Firmware 1.21 and 1.20. ............................................................ 21 Table 13 Mode characteristics ......................................................................................................................... 24 Table 14: Guidance and manufacturer’s declaration – electromagnetic emission .......................................... 30 Table 15: Guidance and manufacturer’s declaration – electromagnetic immunity I........................................ 31 Table 16 Guidance and manufacturer's declaration – electromagnetic immunity II ........................................ 32 Table 17 Safety distances between portable and mobile RF communication equipment............................... 33 Table 18 PACE 203 Exception Error numbers ................................................................................................ 35 Table 19 PACE 203 Other Error numbers ....................................................................................................... 36 Table 20 Peak amplitude vs. ISO 5841-1 amplitudes ..................................................................................... 37 Table 21: List of Spare Parts ........................................................................................................................... 41

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Table of Figures Figure 1: Block Diagram PACE 203 ...................................................................................................................7 Figure 2: LCD electronics board with SED1540 controller .............................................................................. 22 Figure 3: LCD electronics board with ST7522 controller and SED1565 controller (5V) ................................. 22 Figure 4: LCD electronics board with ST7522 controller and SED1565 controller (3.3V) .............................. 22 Figure 5 V00 Timing Cycle .............................................................................................................................. 25 Figure 6 A00 Timing Cycle .............................................................................................................................. 25 Figure 7 VVI Timing Cycle with Inhibition by V-Sense .................................................................................... 25 Figure 8 AAI Timing Cycle with Inhibition by A-Sense .................................................................................... 25 Figure 9 D00 Timing Cycle .............................................................................................................................. 26 Figure 10 VDD Timing Cycle with V-Sense in AVD ........................................................................................ 26 Figure 11 DDD Timing Cycle with V-Sense in AVD ........................................................................................ 27 Figure 12 DDD Timing Cycle with A-Sense in AEI .......................................................................................... 27 Figure 13 DAI Timing Cycle with A-Sense in AEI ............................................................................................ 28 Figure 14 DVI Timing Cycle with Inhibition by V-Sense in AEI ....................................................................... 28 Figure 15 DDD Timing Cycle with A-Pace Triggered by A-Sense in AEI ........................................................ 29 Figure 16: Text messages for error numbers .................................................................................................. 34 Figure 17 Atrial output pulse (at manufacturer's default settings) ................................................................... 38 Figure 18 Ventricular output pulse (at manufacturer's default settings) .......................................................... 38 Figure 19: Circuit Diagram of Power Management & Encoder ....................................................................... 42 Figure 20: Circuit Diagram of MCU & Peripherals ........................................................................................... 43 Figure 21 Circuit Diagram of Stimulation Amplifier .......................................................................................... 44 Figure 22 Circuit Diagram of ECG Amplifier .................................................................................................... 45 Figure 23 Assembly Plan of Power Board top ................................................................................................. 46 Figure 24 Assembly Plan of Power Board bottom ........................................................................................... 47 Figure 25 Assembly Plan of Main Board top ................................................................................................... 48 Figure 26 Assembly Plan of Main Board bottom ............................................................................................. 49 Figure 27 Assembly Plan of Upper Case ........................................................................................................ 50 Figure 28 Assembly Plan of Lower Case ........................................................................................................ 51

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1 Technical Description 1.1 Overview The Osypka Medical PACE 203 is a dual-chamber chamber external pacemaker (also referred to as a pulse generator). This technical manual refers to the PACE 203 either as PACE 203 or PACE 203H. The distinction between PACE 203 and PACE 203H is just a branding issue, not a technical difference. PACE 203 is classified as CF electrical medical equipment1 with an internal power source.

1.2 Classifications Region

Class

Reference

Europe

IIb Medical Product

Council Directive 93/42/EEC of 14 June 1993 (‘Medical Device Directive’), Annex IX

USA

Class III Device

21 CFR 862-892 [807.87(c)]

Japan

Specially Controlled Medical Device

The Pharmaceutical Affairs Law (Law No. 145 dated August 10, 1960) Article 2, Paragraph 5

Class III Medical Devices

PFSB (Yakushoku) Notification No. 0720022, July 20, 2004 and PFSB (Yakushoku) Notification No. 0510 (8), May 10, 2013

Table 1: Medical Device Classifications

1.3 Applicable Standards IEC 60601-1:2012

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, Edition 3.1

IEC 60601-1-2:2007

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests, 2nd Edition

IEC 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 60601-2-31:2011

Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source, Edition 2.1

ISO 14971:2012

Medical devices - Application of risk management to medical devices Table 2: Applicable Standards

1 ISO 60601-1

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1.4 Electronic Block Diagram Figure 1 shows a block diagram of the electronic circuitry. The Microcontroller & Peripherals represents the digital part of the electronic. Peripherals are addressed by the microcontroller. They exchange data and control signals with the other parts. A ‘watchdog’ circuit performs proper system reset after power up and supervises the software for proper functioning. The ECG Amplifier consists of an atrial and ventricular channel. It is responsible for filtered amplification of P and R waves and generating a trigger signal to the microcontroller if the adjusted sensing threshold is reached. A blanking circuit prevents amplifier overload during pacing. The Stimulation Amplifier generates the stimulation pulses with adjustable amplitudes for both channels: atrial and ventricular. It also contains runaway protection, short circuit detection and stimulation current measurement. The runaway protection limits the rate in case of a component or system failure. The short circuit detection generates a signal to the microcontroller to warn the user in case of a short circuit in the lead system. The stimulation current is measured for determining the impedance of the patient circuit. In case of disconnected patient leads the user is alerted. The Power Management provides all voltages needed for proper functioning of the electronic circuitry. A wrong polarity protection ensures that no hazardous situation may occur if a new battery is inserted in a wrong polarity direction. To maintain pacing during battery change special capacitors supply the pulse generator with energy. The User Interface represents the LCD and all keys and dials. Four LED indicate sensing and pacing in both channels. A beeper supports the optical indication acoustically.

User Interface

ECG Amplifier

Microcontroler & Peripherals

Stimulation Amplifier

Power Management

Figure 1: Block Diagram PACE 203

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1.5 Mechanics The pacemaker body is divided unto an upper case, a lower case, a battery cover and a lock. The electronic assembly comprising of two printed circuit boards and the LCD module is embedded in the body. . Upper and lower body cases are made of ABS plastic. Two rubber gaskets ensure protection against liquid ingress. A first gasket separates the upper and the lower part. A second gasket is applied between the battery cover and the lower case. The user interface incorporates 1) Six dial knobs sitting on encoder shafts: a.

High knobs are employed for adjustment of Stimulation rate (‘RATE’), and atrial and ventricular output amplitudes (‘A-STIM’, ‘V-STIM’);

Flat knobs are used for adjustment of AV-delay (‘A-V DLY’) and atrial and ventricular sensitivity thresholds (‘A-SENSE’, ‘V-SENSE’);

2) 9 keys integrated into the key foil; foil material: Polyethylene (PE); 3) LCD display. Open the battery compartment by first moving the battery release button cover located on the back of the device to the side and then push the release button. The battery release button cover is intended to avoid accidental opening of the battery compartment and release of the battery. Inside the battery compartment two springs connect battery terminals and electronic circuitry. A screw spring attached to the release button pulls the button back to its default position. On the top of the PACE 203 there are four protected lead connection terminals (V-, V+, A-, A+) located. They are suitable for plugs with a diameter of 0.9 mm to 2.0 mm. The terminals are made of PA-plastic. On the rear side of the enclosure there is a metal hanger. The metal hanger attached to the rear side of the PACE 203 can be deployed in three snap-in positions to either hang the device or have it stand or lay on a table top.. The CTRL-Out-socket located at the bottom of the PACE 203 is covered by a rubber cap.

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2 Function Check The function check shall be made with pacemaker test equipment. There are different models available on market. The chosen model's instructions for use must be followed. As an example for a function check procedure with a pacemaker analyzer see Section 1.1. The following measurements and inspections must be carried out: •

Measuring the stimulation parameters (amplitude, pulse width) in the atrial and ventricular channels

•

Measuring the rate

•

Measuring the sensitivity in the atrial and ventricular channels

•

Inspecting the battery surveillance and measuring the power maintenance time

•

Inspecting the lead surveillance

Additionally the following measurements and inspections may be made: •

Measuring the refractory period in the atrial and ventricular channels

•

Measuring the A-V delay

•

Inspecting the atrial overdrive stimulation

•

Inspecting the emergency setting

•

Inspecting the interference behavior

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3 Safety Check This safety check is based on the international standards referred to in the section 1.3 on page 6.

The following measurement equipment and auxiliary means are required: •

Safety tester according to IEC 60601-1

•

Digital multimeter

•

Oscilloscope

•

High voltage tester

•

Metal foil, to get an intimate contact with the insulating enclosure of the PACE 203

•

A metal surface of 20 cm × 25 cm

•

Diverse leads with 2 mm and 4 mm plugs, measuring probes, two 100 kΩ resistors

From a safety point of view, an external pulse generator belongs to the internally powered equipment class and has a CF degree of protection against electric shock. The external pulse generator PACE 203 is characterized as follows: an enclosure made of insulating material; two applied parts (atrial and ventricular channel), each applied part with the two patient connections DIFF (black terminal) and INDIFF (red terminal). The following chapters describe all safety tests contained in the above-mentioned standards, which are applicable to external pulse generators with internal power supply. As a safety check of the PACE 203 at least measuring the patient auxiliary currents must be carried out. As an example for a safety check procedure with a pacemaker analyzer see section 8.7 on page 52.

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3.1 Micro/Macro Shock Protection Tests The purpose of this test is to verify the micro/macro shock protection according to the above standards which includes measurement of: •

Enclosure leakage current (source IEC 60601-1, subcl. 19)

•

Patient leakage current between patient connections and enclosure (source IEC 60601-1, subcl. 19)

•

Dielectric strength (source IEC 60601-1 subcl. 14.6 c and IEC 60601-2-31 subcl. 5.2, IEC 60601-1 subcl. 20)

The measuring methods of this test shall strongly agree with the respective IEC standards. The test is divided into three parts: •

Measurement of Enclosure Leakage Current,

•

Measurement of Patient Leakage Current,

•

Insulation Test.

Table 3 shows the allowable values for the leakage currents.

Current

Unit #1

Allowable Value #2

Enclosure leakage current

0.1

Patient leakage current between atrial diff connection and enclosure

0.01

Patient leakage current between atrial indiff connection and enclosure

0.01

Patient leakage current between ventricular diff connection and enclosure

0.01

Patient leakage current between ventricular indiff connection and enclosure

0.01

Patient leakage current with voltage 250 VAC applied between atrial diff connection and enclosure

0.05

Patient leakage current with voltage 250 VAC applied between atrial indiff connection and enclosure

0.05

Patient leakage current with voltage 250 VAC applied between ventricular diff connection and enclosure

0.05

Patient leakage current with voltage 250 VAC applied between ventricular indiff connection and enclosure

0.05

Table 3 Leakage currents

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Table 4 shows the insulation to be tested.

Insulation to be tested Case B-d (Basic Insulation) Between enclosure and atrial diff patient connection Between enclosure and atrial indiff patient connection Between enclosure and ventricular diff patient connection Between enclosure and ventricular indiff patient connection Between signal output connections and atrial diff patient connection Between signal output connections and atrial indiff patient connection Between signal output connections and ventricular diff patient connection Between signal output connections and ventricular indiff patient connection Table 4 Insulation to be tested

3.1.1 Measurement of Enclosure Leakage Current The enclosure leakage current shall be measured between different parts of the enclosure according to IEC 60601-1, subcl. 19.1 c and 19.4 g 3. A proper measuring device is also given in accordance with the IEC 60601-1 standard and is shown there in figure 18. The subcl. 2.1.6 of IEC 60601-1 defines as an enclosure also all accessible metal parts, knobs and the like, so for measurement of enclosure leakage current both the socket (CTRL OUT) for connection of a serial interface cable and the pacers hanger shall be taken into account. The exterior surface of the pacer made of insulating material shall be covered with a metal foil (according to IEC 60601-1, subcl. 19.4 g 5) of max. 10 x 20 cm. The metal foil shall be pressed towards the insulating material of the enclosure (using foam/rubber of the same dimension as the metal foil). Taking the above considerations into account the enclosure leakage current shall be measured between: 1. the socket (CTRL OUT) for connection of a serial interface cable and the metal foil pressed against the insulating part of enclosure 2. the pacers hanger and the metal foil pressed against the insulating part of enclosure The measured values shall not exceed the values given in Table 3.

3.1.2 Measurement of Patient Leakage Current The test shall be carried out with the safety tester. Its instructions for use shall be exactly followed. Normal Condition For the normal condition the standard ICE 60601-1, subcl. 19.4 h 6 shall be taken into account where figure 23 shows the proper measuring device. The exterior surface of the pacer made of insulating material shall be covered with a metal foil (according to IEC 60601-1, subcl. 19.4 g 5) of max. 10 x 20 cm. The metal foil shall be pressed towards the insulating material of the enclosure (using foam/rubber of the same dimension as the metal foil). According to the standard IEC 60601-1, subcl. 19.1 e /Appendix K the patient leakage current shall be measured between each patient connection and the enclosure covered with the metal foil. The pacer shall be set to DDD mode with standard parameters. In particular the patient leakage current shall be measured between the parts and the values shall not exceed the values given in Table 3. 5I-17-013X-B-18

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Single Fault ConditionAccording to the standard IEC 60601-1, subcl. 19.1 e /Appendix K and the ICE 60601-1, subcl. 19.4 h 7 (measuring device see figure 24) the patient leakage current shall be measured between each patient connection and the enclosure covered with the metal foil for single fault condition applying 250 V (in accordance with IEC 60601-1, subcl. 19.1 b) to each patient connection. The enclosure made of insulating material shall be placed in any position of normal use upon a flat metal surface connected to earth with dimensions at least equal to the plan-projection of the enclosure (see ICE 60601-1, subcl. 19.4 h 7). The pacer shall be set to DDD mode with standard parameters. All other constraints described in case of normal condition for measuring the patient leakage current are also valid for single fault condition. In particular the patient leakage current shall be measured for single fault condition in following cases: 1. with voltage 250 VAC between atrial diff connection and enclosure 2. with voltage 250 VAC between atrial indiff connection and enclosure 3. with voltage 250 VAC between ventricular diff connection and enclosure 4. with voltage 250 VAC between ventricular indiff connection and enclosure The measured values shall not exceed the values given in Table 3.

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3.1.3 Insulation Test The test shall be carried out with the high voltage tester. Its instructions for use shall be exactly followed. The insulation test shall occur according to IEC 60601-1, subcl. 20.2 B-d. Values of test voltages are specified in IEC 60601-1, subcl. 20.3, table V. In case of the pacer P203H a basic insulation shall be tested. The exterior surface of the pacer made of insulating material shall be covered with a metal foil (according to IEC 60601-1, subcl. 19.4 g 5) of max. 10 x 20 cm. The metal foil shall be pressed towards the insulating material of the enclosure (using foam/rubber of the same dimension as the metal foil). Care shall be taken that the metal foil is positioned in a manner that flashover does not occur at the edges of insulation linings. If possible, the metal foil should be moved so as to test all parts of the surface. During the insulation test the pacer shall be switched off. The insulation test shall be done for a reference voltage of 50 V ≤ U ref ≤ 150 V (this case is valid for activated EL-backlight). The test voltage shall be equal to 1000 V. The test shall be carried out in accordance with IEC 60601-1, subcl. 20.4. Initially, not more than 500 V shall be applied, then the test voltage shall be gradually raised over a period of 10 s to 1000 V, which shall be maintained for 1 min. after which it shall be gradually lowered over a period of 10 s to less than 500 V. The insulation test shall occur between the parts shown in Table 4.

3.2 Measurement of Patient Auxiliary Current The purpose of this test is to verify the tissue protection, which includes measurement of: •

atrial and ventricular patient auxiliary currents (source IEC 60601-2-31, subcl. 19.3 a)

The Patient Auxiliary Current shall be measured according to the standard IEC 60601-2-31, subcl. 19.3 a. The test conditions are described in the standard IEC 60601-2-31, subcl. 19.4 j 4. For measurement of patient auxiliary current the equipment shall be connected as shown in figure 27 of the general standard to a d.c. measuring device with an input resistance of 100 kΩ. The equipment shall be connected to the measuring device for a minimum of 5 min. before making the patient auxiliary measurement. The patient auxiliary current will be measured just before the pacing pulse. In this case the measured voltage shall not exceed 100 mV. According to the IEC 60601-1, subcl. 19.1 f and g /Appendix K, the measurement of patient auxiliary current shall be done between: 1. atrial diff connection and atrial indiff connection (DDD mode) 2. ventricular diff connection and ventricular indiff connection (DDD mode) 3. atrial diff connection and ventricular indiff connection (DDD mode) 4. ventricular diff connection and atrial indiff connection (DDD mode) 5. atrial diff and atrial indiff, ventricular diff and ventricular indiff connected together (AAI mode) 6. atrial indiff and atrial diff, ventricular diff and ventricular indiff connected together (AAI mode) 7. ventricular diff and ventricular indiff, atrial diff and atrial indiff connected together (VVI mode) 8. ventricular indiff and ventricular diff, atrial diff and atrial indiff connected together (VVI mode)

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3.3 Runaway Protection Test The purpose of this test is to verify that the runaway protection limits the pulse rate in the event of a single fault condition (source IEC 60601-2-31, subcl. 51.104 a). To carry out this test, first the service mode of the PACE 203 must be entered. See section 4.1.1 on page 16 for how to activate the service mode. Note that 10 minutes after the last user operation the device automatically terminates the service mode and returns to normal operation. While being in the service mode the check for abnormal settings is disabled and it is possible to dial an abnormal high pacing rate in order to perform the runaway protection test. For the runaway protection test the rate of the stimulation pulse must be measured by an oscilloscope or other suitable equipment. Then with the corresponding dial the pulse rate shall be increased over 220 ppm until the measured rate goes back to the half value (2:1 block). If this happens, the runaway protection correctly works at the rate just adjusted. The test has to be done in AAI and VVI mode and the observed rate values must be as shown in Table 5.

Channel

Unit

Value

Tolerance

Atrial channel runaway protection

ppm

238

±3

Ventricular channel runaway protection

ppm

238

±3

Table 5 Runaway protection values

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4 Special Service Modes 4.1 Service Mode The device supports a special Service Mode to be used only by authorized service personal or the manufacturer. The service mode must not be used during a clinical application or while a patient is connected to the device. While in service mode the device behaves different compared with normal mode in some ways: •

Allows access to the Service Menu.

•

During service mode the lock symbol is blinking.

•

The check for abnormal settings is disabled in service mode.

•

In service mode it is possible to dial an abnormal high pacing rate in order to perform a runaway protection test (see section 3.3 on page 15).

•

Selecting for standard settings manufacturer's defaults in service mode causes that all defaults will be manufacturer's defaults.

•

The service mode is the pre-condition to enter the Feature and Compatibility Menu.

4.1.1 Activation of Service Mode Activation of the Service Mode requires to enter a hidden key sequence: 1. The device must be turned off. Be sure to power off the device using the OFF state (no storage) and not the STAND-BY state. 2. Press the ON key to power-on the device. 3. Press and hold the LOCK key 4. Press and hold SOFTKEY-1 (the topmost of the 5 softkeys) 5. Press and release SOFTKEY-5 (lowermost of the 5 softkeys) 6. Release SOFTKEY-1 7. Press and release the EMERGENCY key 8. Release the LOCK key 9. The Service Mode should now be activated. This is indicated with a blinking LOCK symbol.

4.1.2 Deactivation of Service Mode To deactivate the Service Mode turn off the device as usual by selecting the OFF state (not the STAND-BY state). If the user does not turn off the device to deactivate the service mode, then 10 minutes after the last user operation the keyboard will be locked and the PACE 203 returns from service mode to normal operation.

4.1.3 Service Menu The Service Menu is a special menu used only by authorized service personal or the manufacturer. For example the service menu allows to change the sound volume, adjust the LCD Contrast or Enable/Disable LCD backlight. Normally service personal does not need to change anything in the service menu except if advised by the manufacturer. To enter the Service Menu the device needs to be in service mode. See section 4.1.1 for how to activate the service mode. While in service mode press the OFF key for the Power-Off Menu which now contains an additional menu entry SERVICE. Select this point to enter the service menu.

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5 Feature and Compatibility Menu The Feature and Compatibility Menu is a special menu used only by authorized service personal or the manufacturer. The goal of this menu is to en/disable certain optional device features2 (since firmware 1.24) and to solve some compatibility issues between different hardware and software revisions (since firmware 1.25).

5.1 Activation of the Feature and Compatibility Menu As a pre-condition the activation of the Feature and Compatibility Menu requires the Service Mode to be enabled. See section 4.1.1 on page 16 for how to activate the Service Mode. After the Service Mode has been activated another hidden key sequence must be entered to enable the Feature and Compatibility Menu:3 1. Be sure that the Service Mode is entered. (The LOCK symbol should be blinking) 2. Press and release OFF key to open the Power-Off menu 3. Press and hold SOFTKEY-2 (second uppermost of the 5 softkeys) 4. Press and hold SOFTKEY-1 (uppermost of the 5 softkeys) 5. Press and release SOFTKEY-3 (middle one of the 5 softkeys) 6. Release SOFTKEY-1 (uppermost of the 5 softkeys) 7. Press and release PAUSE key 8. Release SOFTKEY-2 (second uppermost of the 5 softkeys) 9. The Feature and Compatibility Menu should now be enabled. After the Feature and Compatibility Menu has been enabled this menu can be reached as follows: Press the OFF key for the Power-Off Menu which now contains an addiotional menu entry FEATURES. Select this point to enter the Feature and Compatibility Menu.

5.2 Deactivation of the Feature and Compatibility Menu To deactivate the Feature and Compatibility Menu turn-off the device as usual by selecting the OFF state (not the STAND-BY state). Unlike for deactivation of the Service Mode (section 4.1.2, page 16) the for the Feature and Compatibility Menu does not have auto-deactivation after some minutes.

5.3 Hardware & Software Compatibility Issues Since its market release the device´s hardware and software components have undergone several revisions. For technical reasons hardware and software components generally can operate only in specific combinations of revisions. These combination need to be considered when during device repair a defective hardware component needs to be exchanged with spare parts. In the interest of the customer, to minimize economical impact of spare part changes the manufacturer has created means to solve some compatiblity dependency issues. For technical reasons it is impossible to be able to resolve all compatibility dependencies. Solving Hardware and Software Compatibility issues for spare parts is supported since firmware revision 1.25 which itself requires a pacer main-board4 labelled with 5I-23-511X-X-00, ...-01 or ...-02. With correct adjustments in the compatibility menu one can reach compatibility of all combinations between the hardware 2 for example an adjustable VRP (Ventricular Refractory Period) 3 This means that to enable the Feature and Compatibility Menu the user needs two different key sequences: The first to enable the Service Mode (as a pre-condition) and the second to enable the Feature and Compatibility Menu. 4 Actually all pacer main-boards with a Flash-programmable MCU are supported. Older main-boards with an one-time-programmable external program memory (PROM chip) are not supported by Firmware 1.25.

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and revisions shown in Table 7. But note that some features (like Stimulation Pulse Surveillance) may be unavailable for some combinations. If the device to be repaired contains a pacer main-board labelled with 5I-23-511X-X-00, ...-01 or ...-02 and when it matches one of the hardware and software combinations shown in Table 8 to Table 12, then one should update to firmware 1.25 or above, because this allows solving of Hardware and Software Compatibility issues for spare parts. Pacer main-boards labelled with 5I-23-506X-X-00, ...-01, ...-02 or ...-03 contain a deprecated one-timeprogrammable external program memory (PROM chip)5. In this case consider changing the main-board to be able to run firmware 1.25 or above. The photos in section 5.4 on page 22 can be used to better distinguish the different LCD board generations being referred in the below compatibility tables.

5.3.1 Firmware 1.29 or higher Component Main-Board:

Article Number of PCB Article Number of or other Designator Component Group

Comment / Setting in Feature and Compatibility Menu

5I-23-511X-X-00

5I-27-506Z-X-04

“Main Board = ~00 or ~01”, “Stimulation Pulse Surveillance = No”.

5I-27-506Z-X-04

“Main Board = ~00 or ~01”, “Stimulation Pulse Surveillance = No”.

5I-27-506Z-X-05

“Main Board = ~02 or higher”, “Stimulation Pulse Surveillance = Yes”.

5I-23-512X-X-00 (with 5 capacitors)

5I-27-507Z-X-02

“PMC available = No”

5I-23-512X-X-01

5I-27-512Z-X-01

“PMC available = Yes” for serial numbers above SN#08xxxxxx otherwise “No”

5I-27-512Z-X-02

“PMC available = Yes”

SED1540 controller is square flat pack chip.

5I-25-080Z-X-01

“Display Controller = SED1540 (old)”

ST7522 controller is round plastics mold and SED1565 controller is thick (5 V).

5I-25-080Z-X-02 5I-25-080Z-X-03

“Display Controller = ST7522 (5 V)”

ST7522 controller is round plastics mold and SED1565 controller is thin (3.3 V).

5I-25-080Z-X-04 5I-25-080Z-X-05

“Display Controller = ST7522 (3.3 V)”

1.29 or higher

6I-25-005Z-A-29 You need at least firmware 1.29 to use a LCD (or higher end-index) with 3.3V operation (since Aug. 2013).

(labelled on PCB)

5I-23-511X-X-01 (labelled on PCB)

5I-23-511X-X-02 (labelled on PCB)

Power-Board:

(with 5 capacitors)

5I-23-512X-X-02 (with 5 capacitors)

LCD:

Firmware:

(displayed at startup)

Table 6 Hardware Compatibility Matrix for Firmware 1.29 or higher. All combinations of all componends listed in the table are supported by Firmware 1.29 or higher, but the given adjustments in the “Feature and Compatibility Menu” must be made.

5 Later main-boards do not need a PROM chip because they use reprogrammable internal program memory of the micro-controller.

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5.3.2 Firmware 1.25 + 1.26 + 1.27 + 1.28 Component Main-Board:

Article Number of PCB Article Number of or other Designator Component Group

Comment / Setting in Feature and Compatibility Menu

5I-23-511X-X-00

5I-27-506Z-X-04

“Main Board = ~00 or ~01”, “Stimulation Pulse Surveillance = No”.

5I-27-506Z-X-04

“Main Board = ~00 or ~01”, “Stimulation Pulse Surveillance = No”.

5I-27-506Z-X-05

“Main Board = ~02 or higher”, “Stimulation Pulse Surveillance = Yes”.

5I-27-507Z-X-02

“PMC available = No”

5I-27-512Z-X-01

“PMC available = Yes” for serial numbers above SN#08xxxxxx otherwise “No”

5I-27-512Z-X-02

“PMC available = Yes”

SED1540 controller is square flat pack chip.

5I-25-080Z-X-01

“Display Controller = SED1540 (old)”

ST7522 controller is round plastics mold and SED1565 controller is thick (5 V).

5I-25-080Z-X-02

1.25, 1.26, 1.27 or 1.28

6I-25-005Z-A-25 6I-25-005Z-A-26 6I-25-005Z-A-27 6I-25-005Z-A-28

(labelled on PCB)

5I-23-511X-X-01 (labelled on PCB)

5I-23-511X-X-02 (labelled on PCB)

Power-Board:

5I-23-512X-X-00 (with 5 capacitors)

5I-23-512X-X-01 (with 5 capacitors)

5I-23-512X-X-02 (with 5 capacitors)

LCD:

Firmware:

(displayed at startup)

“Display Controller = ST7522 (new)” (only 5 V supported/available, not 3.3 V)

You need at least firmware 1.25 to solve compatiblity issues.

Table 7 Hardware Compatibility Matrix for Firmware 1.25, 1.26, 1.27 and 1.28. All combinations of all componends listed in the table are supported by Firmwares 1.25, 1.26, 1.27 and 1.28, but the given adjustments in the “Feature and Compatibility Menu” must be made.

5.3.3 Firmware 1.24 Component Main-Board:

Article Number of PCB Article Number of or other Designator Component Group

Comment

5I-23-511X-X-02

5I-27-506Z-X-05

Stimulation Pulse Surveillance is always on.

5I-27-512Z-X-02

PMC is always available

ST7522 controller is round plastics mold and SED1565 controller is thick (5 V).

5I-25-080Z-X-02

LCD controller ST7522 (5 V)

1.24

6I-25-005Z-A-24

(labelled on PCB)

Power-Board:

5I-23-512X-X-02 (with 5 capacitors)

LCD: Firmware:

(displayed at startup)

It is recommended to update to firmware 1.29 and refer to Table 6 on page 18. Table 8 Hardware Compatibility Matrix for Firmware 1.24. Firmware 1.24 supports only the single combination of components noted in the table. This firmware does not offer a "Feature and Compatibility Menu" yet.

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5.3.4 Firmware 1.23 Component

Article Number of PCB Article Number of or other Designator Component Group

Main-Board:

5I-23-511X-X-01

5I-27-506Z-X-04

Stimulation Pulse Surveillance is not supported.

5I-27-512Z-X-01

PMC available for all devices with serial numbers above SN#08xxxxxx.

ST7522 controller is round plastics mold and SED1565 controller is thick (5 V).

5I-25-080Z-X-02

LCD controller ST7522 (5 V)

1.23

6I-25-005Z-A-23

(labelled on PCB)

Power-Board:

5I-23-512X-X-01 (with 5 capacitors)

LCD: Firmware:

Comment

(displayed at startup)

It is recommended to update to firmware 1.29 and refer to Table 6 on page 18. Table 9 Hardware Compatibility Matrix for Firmware 1.23. Firmware 1.23 supports only the single combination of components noted in the table. This firmware does not offer a "Feature and Compatibility Menu" yet.

5.3.5 Firmware 1.22 Component

Article Number of PCB Article Number of or other Designator Component Group

Main-Board:

5I-27-506Z-X-04

Stimulation Pulse Surveillance is not supported.

5I-27-512Z-X-01

PMC available for all devices with serial numbers above SN#08xxxxxx.

SED1540 controller is square flat pack chip.

5I-25-080Z-X-01

LCD controller SED1540 (old).

1.22

6I-25-005Z-A-22

5I-23-511X-X-01 (labelled on PCB)

Power-Board:

5I-23-512X-X-01 (with 5 capacitors)

LCD: Firmware:

Comment

(displayed at startup)

It is recommended to update to firmware 1.29 and refer to Table 6 on page 18. Table 10 Hardware Compatibility Matrix for Firmware 1.22. The firmware 1.22 supports only the single combination of components noted in the table. This firmware does not offer a "Feature and Compatibility Menu" yet.

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5.3.6 Firmware 1.21.1 Component

Article Number of PCB Article Number of or other Designator Component Group

Main-Board:

5I-23-511X-X-01

5I-27-506Z-X-04

Stimulation Pulse Surveillance is not supported.

5I-27-507Z-X-02

PMC is not available

ST7522 controller is round plastics mold and SED1565 controller is thick (5 V).

5I-25-080Z-X-02

LCD controller ST7522 (5 V)

1.21.1

6I-25-005Z-A-21

(labelled on PCB)

Power-Board:

Comment

5I-23-512X-X-00 (with 5 capacitors)

LCD: Firmware:

(displayed at startup)

It is recommended to update to firmware 1.29 and refer to Table 6 on page 18. Table 11 Hardware Compatibility Matrix for Firmware 1.21.1. The firmware 1.21.1 supports only the single combination of components noted in the table. This firmware does not offer a "Feature and Compatibility Menu" yet.

5.3.7 Firmware 1.21 + 1.20 Component Main-Board:

Article Number of PCB Article Number of or other Designator Component Group 5I-23-511X-X-01

5I-27-506Z-X-04

Stimulation Pulse Surveillance is not supported.

5I-27-507Z-X-02

PMC is not available

SED1540 controller is square flat pack chip.

5I-25-080Z-X-01

LCD controller SED1540 (old).

1.20

6I-25-005Z-A-20

Upgrade from Firmware 1.20 to 1.21 recommended.

6I-25-005Z-A-21

Firmware 1.21 can run on the same hardware as 1.20.

(labelled on PCB)

Power-Board:

Comment

5I-23-512X-X-00 (with 5 capacitors)

LCD: Firmware:

(displayed at startup)

1.21 (displayed at startup)

It is recommended to update to firmware 1.29 and refer to Table 6 on page 18. Table 12 Hardware Compatibility Matrix for Firmware 1.21 and 1.20. The firmware 1.21 and 1.20 support only the single combination of hardware components noted in the table. This firmwares do not offer a "Feature and Compatibility Menu" yet.

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5.4 LCD Board Generations

Figure 2: LCD electronics board with SED1540 controller

Figure 3: LCD electronics board with ST7522 controller and SED1565 controller (5V)

Figure 4: LCD electronics board with ST7522 controller and SED1565 controller (3.3V)

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6 Pulse Generator Timing 6.1 General 6.1.1 Terms Used terminology in next sections agrees with definitions given in section Definitions. The following terms will be used in formulas and parameter specifications. tLRI

LRI

tURI

URI

tARP

ARP

tPVARP

PVARP

tPVARPa

Absolute PVARP

tPVARPr

Relative PVARP

tVRP

VRP

tAVI

AVI

tAVD

AVD

tAEI

AEI

tEI

Escape Interval (EI)

tABP

ABP

tVBP

VBP

tDCHP

Discharge Period

tDCHD

Discharge Delay after Pulse

Pulse Duration

Pulse Interval ( tP = 1/fP , tP [ms]=60000 /fP [ppm])

Pulse Rate ( fP = 1/tP )

fLR

Basic Rate, Lower Rate ( fLR = 1/tLRI )

AISO

Pulse Amplitude (Voltage) per ISO 5841-1, Section B.2.2

Pulse Amplitude (Peak Voltage)

ROUT

Pulse Generator Output Resistance

Pulse Generator Load Resistance

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6.1.2 Symbols Legend of Symbols:

Running Interval Cancelled Interval Prolonged Interval Relative Refractory Period

Stimulation Pulse V-Sense or R-Sense (test signal suitable for atrial and ventricular sensing evaluation as specified in ISO 5841-1, Section B.1.4) Interference or cross talk

6.2 Mode Characteristics Table 13 shows the characteristic of each implemented mode. Mode6

AAPace Sense

A00

AAI

Events V-Pace

VVI

DDD

VDD DVI

DAI

VAI

PV Delay

Safety Wenck. Window Cond.

V00

D00

VSpec. PVC Sense React.

(no!)

Atrial Trigger

Emerg. Mode

N/A

V007/A00

N/A

V00/A00

N/A

V00

N/A

V00

N/A

V00

N/A

V00

N/A

V00

Table 13 Mode characteristics

PVC is only detectable in dual chamber modes with ventricular sensing. Wenckebach behavior requires the capability of atrial sensing (tracking) and ventricular pacing by atrial control. Safety window pacing is only possible in such modes that combine atrial pacing and ventricular sensing. Precisely there must be a previous atrial pace combined with the current ability of ventricular sensing.

Does not include all modes derived from 16 sense/pace combinations.

V00 only if a valid lead can be detected, else A00.

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6.3 Asynchronous modes (V00 or A00) Regardless of intrinsic of intrinsic rhythm, ventricular or atrial stimulation impulses will be emitted with the set basic rate. Figure 5 and Figure 6 show the timing.

V Lower Rate Interval

t LRI Figure 5 V00 Timing Cycle

A Lower Rate Interval

t LRI Figure 6 A00 Timing Cycle

6.4 Inhibited Single-chamber Modes (VVI or AAI) In the absence of intrinsic activity, ventricular or atrial stimulation impulses will be given with the set basic rate. The recognition of an R-wave in VVI-mode or a P-wave in AAI mode in the pacemaker’s sensing phase inhibits the emission of the next stimulation impulse, resets the timing of the pacemaker to the beginning of the beat-to-beat interval and starts the refractory period. Figure 7 and Figure 8 show the timing.

V Lower Rate Interval

t LRI

Refractory Period

tVRP

Escape Interval

t EI Figure 7 VVI Timing Cycle with Inhibition by V-Sense

A Lower Rate Interval

t LRI

Refractory Period

t ARP

Escape Interval

t EI Figure 8 AAI Timing Cycle with Inhibition by A-Sense

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6.5 Asynchronous Dual-chamber Mode (D00) Regardless of intrinsic rhythm, atrial and ventricle stimulation impulses will be emitted with the set basic rate, whereas the stimulus in the ventricle will be given after the atrial stimulus according to the set A-V delay. Figure 9 shows the timing.

Lower Rate Interval

t LRI

AV-Delay

t AVD

V t AEI

Atrial Escape Interval

Figure 9 D00 Timing Cycle

6.6 Dual-chamber Mode without Atrial Stimulation (VDD) In this mode there is stimulation only in the ventricle, but sensing is possible in both channels. In the absence of intrinsic activity, ventricular stimulation impulses will be given with the set basic rate. The recognition of a P-wave in the atrial sensing phase resets the timing of the pacemaker to the beginning of the beat-to-beat interval and starts the atrial refractory period as well as the P-V delay. If the beat-to-beat interval (or the V-A delay respectively) completes its cycle without a P-wave being detected, the A-V delay will be started. The recognition of an R-wave during the A-V or P-V delay inhibits the emission of the ventricular stimulation impulse and starts the ventricular refractory period as well as the V-A delay. If the A-V or P-V delay expires without an R-wave being detected, a ventricular stimulus will be emitted and the ventricular refractory period as well as the V-A delay will be started.

A Lower Rate Interval

t LRI

Atrial Refr. Period

t ARP

PVARP

t PVARP

AV-Delay

t AVD t AVI

V Ventricular Refr. Period

tVRP

Atrial Escape Interval

t AEI

Figure 10 VDD Timing Cycle with V-Sense in AVD

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6.7 Dual-Chamber Universal Mode (DDD) In this mode, stimulation and sensing are possible in both channels. In the absence of intrinsic activity, the atrium and ventricle will be stimulated with the set basic rate, whereas the stimulus in the ventricle is delayed according to the set A-V delay after the atrial-stimulus is given. The sensing of a P-wave in the atrial sensing phase of the pacemaker inhibits the emission of the atrial stimulation impulse, resets the timing of the pacemaker to the beginning of the beat-to-beat interval and starts the atrial refractory period as well as the P-V delay. If the beat-to-beat interval (i.e. the V-A delay) expires without a P-wave being detected, an atrial stimulus will be given and the atrial refractory period as well as the A-V delay will be started. The sensing of an R-wave during the A-V or P-V delay inhibits the emission of the ventricular stimulation impulse and starts the ventricular refractory period as well as the V-A period. If the A-V or P-V delay expires without an R-wave being detected, a ventricular stimulus will be given and the ventricular refractory period as well as the V-A delay will be started. Figure 11 and Figure 12 show two different situations, which can occur in DDD.

A Lower Rate Interval

t LRI

Atrial Refr. Period

t ARP

PVARP

t PVARP

AV-Delay

t AVD

t AVI

Ventricular Refr. Period

tVRP

Atrial Escape Interval

t AEI

Figure 11 DDD Timing Cycle with V-Sense in AVD

A Lower Rate Interval

t LRI

Atrial Refr. Period

t ARP

PVARP

t PVARP

AV Delay

t AVD

PV Delay

t PVD

V Ventricular Refr. Period

tVRP

Atrial Escape Interval

t AEI

Figure 12 DDD Timing Cycle with A-Sense in AEI

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6.8 The Implicitly Adjustable DAI Mode The mode DAI is similar to the DDD mode except that sensing is only possible in the atrial channel. This mode is implicitly adjustable, in that the DDD mode is selected and the sensitivity in the ventricular channel is set to infinite ("–.–"). In this way the sensing of this channel is turned off. A timing of this mode is shown in Figure 13.

A Lower Rate Interval

t LRI

Atrial Refr. Period

t ARP

PVARP

t PVARP

AV Delay

t AVD

PV Delay

t PVD

V Atrial Escape Interval

t AEI Figure 13 DAI Timing Cycle with A-Sense in AEI

6.9 The Implicitly Adjustable DVI Mode The mode DVI is similar to the DDD mode except that sensing is only possible in the ventricular channel. This mode is implicitly adjustable, in that the DDD mode is selected and the sensitivity in the atrial channel is set to infinite ("–.–"). In this way the sensing of this channel is turned off. A timing is shown in Figure 14.

A Lower Rate Interval

t LRI

AV-Delay

t AVD

Ventricular Refr. Period

tVRP

Atrial Escape Interval

t AEI

Figure 14 DVI Timing Cycle with Inhibition by V-Sense in AEI

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6.10 Atrial Trigger Modes (AAT, DDD+AT) If Atrial Trigger option is activated, an atrial stimulus will be emitted as soon as an atrial activity has been sensed in the sensing phase. Figure 15 shows an atrial trigger in DDD.

A Lower Rate Interval

t LRI

Atrial Refr. Period

t ARP

PVARP

t PVARP

AV Delay

t AVD

PV Delay

t PVD

V Ventricular Refr. Period

tVRP

Atrial Escape Interval

t AEI

Figure 15 DDD Timing Cycle with A-Pace Triggered by A-Sense in AEI

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7 EMC Guidance and Manufacturer’s Declaration The PACE 203 needs like every medical electrical device special precautions regarding electromagnetic compatibility (EMC). This section is intended to give the user guidance and information about all aspects to ensure that the PACE 203 operates as intended in an electromagnetic environment. Guidance here given must be followed for putting PACE 203 into service. The user must be aware that the use of leads and patient cables other than those specified in the instruction for use may result in increased electromagnetic emissions or decreased electromagnetic immunity. The PACE 203 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the PACE 203 should be observed to verify normal operation in the configuration in which it will be used.

7.1 Electromagnetic Emission/Radiation Standard: IEC 60601-1-2: Table 1 PACE 203 is intended for use in an electromagnetic environment as described below. The user should make sure that PACE 203 is used in such an environment.

Emissions Test

Complianc e Level

Guidelines for the Electromagnetic Environment

RF emissions CISPR 11

Group 1

PACE 203 uses radio-frequency (RF) energy exclusively for its own function. Therefore, the high-frequency interference is very low and not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions according to IEC 61000-3-2

Not applicable

PACE 203 is suitable for use in all areas, excluding residential areas and buildings that are connected directly to the public power supply lines.

Voltage fluctuations according to IEC 61000-3-3

Not applicable

Table 14: Guidance and manufacturer’s declaration – electromagnetic emission

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7.2 Electromagnetic Immunity Standard: IEC 60601-1-2: Table 2 PACE 203 is intended for use in an electromagnetic environment as described below. The user should make sure that PACE 203 is used in such an environment.

Testing the Immunity to Interference Electrostatic discharge (ESD) IEC 61000-4-2

Test Level according to IEC 60601

Compliance Level

Guidelines for the Electromagnetic Environment Floors should be made of wood, concrete or ceramic tiles. If floors consist of a synthetic material, the relative humidity should be at least 30 %.

± 6 kV contact discharge

± 8 kV air discharge

± 8kV air discharge

Fast transient electrical interference / bursts according to IEC 61000-4-4

± 2 kV for power supply lines

± 1 kV for input / output lines

Not applicable (lines have a length of less than 3 m)

Surge voltages (surges) according to IEC 61000-4-5

± 1 kV differential mode

± 2 kV common mode

Voltage drops, brief interruptions and fluctuations on power supply lines according to IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % drop in UT) for 5 cycles 70 % UT (30 % drop in UT) for 25 cycles <5 % UT (>95 % drop in UT) for 5 seconds

Not applicable

Not applicable (PACE 203 has an uninterruptible power supply)

Magnetic field at the supply frequency (50/60 Hz) according to IEC 61000-4-8

3 A/m

The magnetic field strength should correspond to levels typical to commercial or hospital environments.

NOTE

Quality of power supply lines should be that of typical commercial or hospital environment.

Quality of power supply lines should correspond to levels typical of commercial or hospital environments.

UT is the AC voltage prior to application of the test level

Table 15: Guidance and manufacturer’s declaration – electromagnetic immunity I

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7.3 Electromagnetic Immunity for External Cardiac Pacemakers Standard: IEC 60601-1-2: Table 3 PACE 203 is intended for use in an electromagnetic environment as described below. The user should make sure that PACE 203 is used in such an environment.

Testing the Immunity to Interference

Test Level according to IEC 60601

Compliance Level

Guidelines for the Electromagnetic Environment

Portable and mobile radio-frequency (RF) communication equipment are not used closer to any part of PACE 203, including cables and leads, than the recommended safety distance. Recommended safety distance:

Conducted RF interferences according to IEC 61000-4-6

Radiated RF interference accfording to IEC 61000-4-3

10 Vrms 150 kHz to 80 MHz outside of ISM bandsa

10 Vrms 150 kHz to 80 MHz inside of ISM bandsa

10 V/m 80 MHz to 2.5 GHz

d = [0.35] P

d = [1.2] P d = [1.2] P for 80 MHz to 800 MHz

d = [2.3] P 800 MHz to 2.5 GHz P is the maximum rated power of the transmitter in watts (W) according to the information of the transmitter manufacturer and d is the recommended safety distance in meters (m).b Field strength of stationary RF transmitters must be determined site c and must be be less than the compliance level at all frequenciesd. Interference may occur in the vicinity of devices marked with the following symbol:

Note 1:

At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2:

These guidelines do not necessarily apply in all situations. The propagation of electromagnetic waves is influenced by absorption and reflection from structures, objects and humans.

The ISM bands (for ndustrial, scientific and medical applications) between 150 kHz and 80 MHz are 6.765 MHz to 6,795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz is intended to reduce the likelihood that mobile/portable communications devices cause interference if they are unintentionally brought into patient areas. For this reason greater safety distance is recommended separation distance in these frequency ranges (factor 12 instead of 0.35).

The field strengths of staionary transmitters, such as base stations for mobile phones and land mobile radios, amateur radio stations and radio broadcast and TV broadcasta cannot be predicted with accuracy. To assess the electromagnetic environment by fixed RF transmitters, a study of the location should be considered. If the measured field strength exceeds the HF compliance level at the location where PACE 203 is used, PACE 203 must be observed to ensure correct functioning. Additional measures may be necessary, such as reorienting or relocating PACE 203.

In the frequency range 150 kHz to 80 MHz the field strengths should be less than 10 V/m.

Table 16 Guidance and manufacturer's declaration – electromagnetic immunity II

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7.4 Recommended Safety Distances to Portable and Mobile RF Equipment Standard: IEC 60601-1-2: Table 3 PACE 203 is intended for use in an electromagnetic environment, in which the RF interference is under control. The user of the PACE 203 can help to prevent electromagnetic interference by maintaining a safety distance to mobile RF communication equipment (transmitters) – depending on the output power of the communication equipment. as described below. The user should make sure that PACE 203 is used in such an environment.

Rated output power of transmitter P [W]

Safety Distance d [m] corresponding to Frequency of Transmitter 150 kHz to 80 MHz outside of ISM bands

150 kHz to 80 MHz inside of ISM bands

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = [0.35] P

d = [1.2] P

d = [2.3] P

0.01

0.04

0.12

0.23

0.10

0.11

0.38

0.73

1.00

0.35

1.20

2.30

10.00

1.11

3.79

7.27

100.00

3.50

12.00

23.00

For transmitters whose rated power output is not specified in the table above, the safety can be calculated using the specified formula for the corresponding frequency. Here P is the rated output power of the transmitter in watts [W] and d the safety distance in meters [m]. Note 1:

At 80 MHz and 800 MHz, the safety distance for the higher frequency range applies.

Note 2:

The ISM bands (for industrial, scientific and medical applications) between 150 kHz and 80 MHz are 6.765 MHz to 6,795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

Note 3:

Note 4:

These guidelines do not necessarily apply in all situations. The propagation of electromagnetic waves is influenced by absorption and reflection from structures, objects and humans.

Table 17 Safety distances between portable and mobile RF communication equipment

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8 Appendices 8.1 Error Codes The PACE 203 differentiates between conflicts, application related errors and device related errors, and warning messages. While the instruction for use describe most errors, warnings and conflicts, the description and possible cause of all errors is disclosed in this technical manual. In particular PACE 203 distinguishes between: •

Exception errors and

•

Other errors.

In the event of an exception error the micro-controller unit (MCU) halts and, as a consequence, PACE 203 is not operable. Upon such an exception error the PACE 203 will reset and restart the MCU automatically. After successful restart the MCU reads the previously stored error code and displays this error code prominently in a message in the lower portion of display. The display of the error code (if possible) is accompanied by an acoustic beep pattern corresponding to the error code. In the event of other errors, the MCU and in turn the PACE 203 remains operational. Again, the error code will be displayed in the lower display. Only one high beep tone is generated upon occurrence of such an error. The user is periodically reminded acoustically until the error message is confirmed by the user via the LOCK key. Figure 16 illustrates the typical message formats displaying the error code. (exept for error code 17 for which uses a different format is used). Table 18 and Table 19 show the PACE 203 error codes with their corresponding beep patterns.

Unexpected device error no. ### ! Restart device or submit to inspection

Self test error no. 17! Submit device to inspection. Press <LOCK> to power off.

Figure 16: Text messages for error numbers

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Table 18 PACE 203 Exception Error numbers

Exception Errors Beep Pattern Error number

Comments Low beeps

High beeps

Pacer timers: Overflow of PTM list EXIT_OUTOFMEM_PTM

Events: Overflow of EVT list EXIT_OUTOFMEM_EVT

High-speed timers: Overflow of HST array EXIT_OUTOFMEM_HST

General purpose timers: Overflow of GPT list EXIT_OUTOFMEM_GPT

Menu: Not enough memory for menu EXIT_OUTOFMEM_MENU

RAM error EXIT_HW_RAM

ROM error EXIT_HW_ROM

Unexpected MCU exception EXIT_CPU_UND

Unexpected MCU exception EXIT_CPU_INTO

Unexpected MCU exception EXIT_CPU_BRK

Unexpected MCU exception EXIT_CPU_ADRMATCH

Unexpected MCU exception EXIT_CPU_STEP

Unexpected MCU exception EXIT_CPU_WDOVF

Unexpected MCU exception EXIT_CPU_DBC

External Watchdog overflow EXIT_CPU_NMI

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Osypka Medical PACE 203 – Technical Manual

Table 19 PACE 203 Other Error numbers

Other Errors Error number

High beeps

Inconsistency of time bases ERR_TIMEBASE

Bad analog/reference voltage ERR_ANA_REF_VOLTAGE

ADC corrupt ERR_ADC

Power off failed ERR_FAIL_PWROFF

Atrial sense during atrial blanking ERR_BLNKATR

Ventricular sense during ventricular blanking ERR_BLNKVEN

Power On stimulation self test failed ERR_PWRON_STIMERR

Configurable hardware feature (see section 5.3 on page 17) not readable or has not been defined. ERR_HWFEATURE_LOST

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Comments

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Osypka Medical PACE 203 – Technical Manual

8.2 Stimulation Amplitude According to ISO Definition The amplitude of the stimulation pulse indicated on the PACE 203 display is equal to the peak pulse amplitude. This was chosen for an easy measurement of the pulse amplitude, but it differs from the test procedure in ISO 5841-1, Subclause B.2.2 where the pulse amplitude is calculated from the time integral over voltage divided by the pulse duration. The pulse duration shall be measured between the points on the pulse waveform where the amplitude is equal to one-third of the peak pulse amplitude. With the following equation the ISO 5841-1 amplitude can be calculated from the peak pulse amplitude:

−

D RLC

1− e AISO = APEAK ( D RL C There is D: pulse duration, RL: load resistance and C: capacitor in load circuit:

)

10 µF in PACE 203 with S/N ≥ 1024001 at resistive load).

Table 20 shows calculated values for standard load RL = 500 Ω and standard pulse durations D = 0.75 ms (ventricle), D = 1.00 ms (atrium). Table 20 Peak amplitude vs. ISO 5841-1 amplitudes

5I-17-013X-B-18

APEAK [V]

AISO [V]

0.93

1.86

2.79

3.71

4.64

5.57

6.50

7.43

9.29

11.14

13.00

14.86

16.72

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Osypka Medical PACE 203 – Technical Manual

8.3 Waveform of Stimulation Pulse Figure 17 and Figure 18 show the waveforms of an atrial respectively ventricular pacer output pulse (at manufacturer's default settings). These waveforms are applicable only for pacer main-boards with an article number 5I-23-511X-X-02 (or higher) labeled on the PCB. This should be the case for all devices with a serial number higher or equal than 1035001 on the back side of the housing. For older devices please refer to a previous version of this document.

Figure 17 Atrial output pulse (at manufacturer's default settings)

Figure 18 Ventricular output pulse (at manufacturer's default settings)

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Osypka Medical PACE 203 – Technical Manual

8.4 Sensitivity for sin² Test Impulses The sensitivity S (in mV) of the PACE 203 is adjusted by the manufacturer applying the triangle 2ms/13ms test impulse as specified in ISO 5841-1, Subclause B.1.4 (SISO). With the following equations the corresponding sensitivities for sin² test impulses can be calculated: 15 ms pulse duration:

S sin 2 / 15 ms = 0 .77 * S ISO

25 ms pulse duration:

S sin 2 / 25 ms = 0 .83 * S ISO

40 ms pulse duration:

S sin 2 / 40 ms = 1.19 * S ISO

The formulas have to be interpreted as in the following example: If the sensitivity of the PACE 203 is set to 1 mV (displayed value) and a 15 ms-sin² test impulse is used, it is as if the sensitivity has been set to 0.77 mV. With other words: A 15 ms-sin² impulse with an amplitude of 0.77 mV will just be recognized by the PACE 203, when its sensitivity parameter is set to "1 mV". The formulas can also be reversed like in the following example: When a 15 ms-sin² impulse with an amplitude of 1 mV shall just trigger the PACE 203, its sensitivity must be set to 1.3 mV (= 1/0.77 mV).

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Osypka Medical PACE 203 – Technical Manual

8.5 Spare Part List Pos.

Quantity

Name

Part Number

PACE203H Upper Housing Subassembly incl. Key Foil, Screen Glass with MAINS Window*

5I-25-079Z-A

PACE203H Upper Housing Subassembly incl. Key Foil, Screen Glass w/o MAINS Window*

5I-25-079Z-E

PACE203H Lower Housing Subassembly incl. Battery Cover, Electrode Terminals, CTRL-Out Socket, Housing Feet*

5I-25-076Z-A

PACE203H Battery Cover*

5I-25-087Z-A

PACE203H Hanger

5I-28-093Z-A

PACE203H Terminal Cap red

5I-25-096Z-A

PACE203H Terminal Cap black

5I-25-096Z-B

PACE203H Screw Cover

5I-28-101Z-A

PACE203H Housing Foot

5I-28-100Z-A

10.

PACE203H Knob flat light blue (Rate)

5I-28-090Z-B

11.

PACE203H Knob flat dark blue (A-Stim)

5I-28-090Z-C

12.

PACE203H Knob flat white (V-Stim)

5I-28-090Z-A

13.

PACE203H Knob high light blue (A-V Delay)

5I-28-089Z-B

14.

PACE203H Knob high dark blue (A-Sense)

5I-28-089Z-C

15.

PACE203H Knob high white (V-Sense)

5I-28-089Z-A

16.

PACE203H Energy Storing Capacitor EECAOEL105 preassembled (4pcs. are needed for 1 device) *

5I-25-103Z-A

17.

PACE203H Energy Storing Capacitor EECAOEL105 w/o diode (5pcs. are needed for 1 device) *

9E-28-8403-B

18.

PACE203H Battery Terminal Spring*

5I-28-092Z-B

19.

O-Ring 4,0,1, 00N 70Shore A black

9A-28-0017-A

20.

PACE203H Encoder*

9E-28-8426-A

21.

PACE203H Encoder Gasket*

5I-28-099Z-A

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Osypka Medical PACE 203 – Technical Manual

Pos.

Quantity

Name

Part Number

22.

PACE203H Back Foil incl. Battery Button Cover

5I-25-104Z-A

23.

Silicone Paste (Bayer-Silicone) Tube for Lubrication for Encoders

9Q-28-8007-A

24.

Loctite 454 Tube to fix the Knobs

25.

26.

9Q-28-0024-A

Loctite 406 incl. Primer 770 to fix the Housing Feet

9Q-28-8013-A

PACE203H CTRL-OUT socket pre-assembled*

5I-25-095Z-A

27.

PACE203H CTRL-OUT Cap

5I-28-059Z-A

28.

Buzzer Piezo Digisound*

9E-28-8215-B

29.

Screw M3x4

9A-28-8055-A

30.

Washer M3*

9A-28-8007-A

31.

Thread Bolt M3x7 w/ Thread 6mm (to ass. Power Board) *

9A-28-8105-A

32.

Thread Bolt M3x7 w/ Thread 4mm (to ass. LCD to housing) *

9A-28-8109-A

33.

Thread Bolt M3x7 w/ Thread 4mm, plastic (to ass. LCD to housing) *

9A-28-8109-B

34.

Pin 2M6x16 A2 Stainless Steel*

9A-28-8106-A

35.

LED for Sense green ø 5mm*

9E-28-8316-B

36.

LED for Stim. yellow ø 5mm*

9E-28-8488-B

37.

LED for Sense green 2x4mm*

9E-28-8802-B

38.

LED for Stim. yellow 2x4mm*

9E-28-9128-B

39.

PACE203H Carrying Case

5I-25-101Z-C

40.

PACE203H Protection Bag

5I-28-108Z-A

Table 21: List of Spare Parts

Note: * Parts available only for authorized/trained customers

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Osypka Medical PACE 203 – Technical Manual

8.6 Circuit Diagrams and Assembly Drawings

Figure 19: Circuit Diagram of Power Management & Encoder 5I-17-013X-B-18

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Osypka Medical PACE 203 – Technical Manual

Figure 20: Circuit Diagram of MCU & Peripherals

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Osypka Medical PACE 203 – Technical Manual

Figure 21 Circuit Diagram of Stimulation Amplifier

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Osypka Medical PACE 203 – Technical Manual

Figure 22 Circuit Diagram of ECG Amplifier

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Osypka Medical PACE 203 – Technical Manual

Figure 23 Assembly Plan of Power Board top 5I-17-013X-B-18

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Osypka Medical PACE 203 – Technical Manual

Figure 24 Assembly Plan of Power Board bottom

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Osypka Medical PACE 203 – Technical Manual

Figure 25 Assembly Plan of Main Board top 5I-17-013X-B-18

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Osypka Medical PACE 203 – Technical Manual

Figure 26 Assembly Plan of Main Board bottom

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Osypka Medical PACE 203 – Technical Manual

Figure 27 Assembly Plan of Upper Case

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PACE 203 Technical Manual 5I-17-013-B-18