Reocor EDP Ver A and B Production and Inspection Specification Rev B

Production and Inspection Specification

FPV-123-965 Rev. B

Page 2/15

CONTENT 1. INTRODUCTION ... 3 1.1. 1.2. 1.3. 1.4. 1.5.

PURPOSE ... 3 TIME PERIODS OF INSPECTIONS... 3 STANDARDS, LAWS AND REGULATIONS:... 3 MEASURING DEVICES, ACCESSORIES, AIDS, CALIBRATION ... 4 RECORDS ... 4

2. INSPECTION ... 5

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

2.1. VISUAL INSPECTION ... 5 2.1.1. Housing... 5 2.1.2. Protection Cover (transparent plastic cover) ... 5 2.1.3. Setting Dials ... 5 2.1.4. Connectors/Sockets ... 5 2.2. INSPECTION OF THE ELECTRICAL SAFETY ... 6 2.2.1. Protective Earth Resistance... 6 2.2.2. Measurement of the Applied Part Leakage Current (Battery Powered) ... 6 2.2.3. Insulation Resistance ... 8 2.3. FUNCTIONAL TEST... 9 2.3.1. Self Test... 9 2.3.2. Detection ...10 2.3.3. Stimulation ...12 2.3.4. Test of the Lead Impedance Monitoring ...13 2.3.5. Test of the Battery Monitor ...14

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Production and Inspection Specification

FPV-123-965 Rev. B

1.

Introduction

1.1.

Purpose

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This document describes the inspection steps that are necessary to perform an inspection of the devices REOCOR and EDP in order to enable the user or operating organization to inspect the device visually, the basic electrical functions and the electrical safety. Alternatively to the tests that are described in this document the internal final acceptance test of BIOTRONIK could be performed. This document is addressed to individuals that are qualified due to their degree of education, knowledge and practical experience in order to assure correct performance of the instructions. This document is subject of the change management at BIOTRONIK. Thus, the person performing the inspection according to this document has to ensure always using the current revision of the document. The current revision is available at: BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Germany Phone: +49 (0)30 68905-0

1.2.

Time Periods of Inspections The devices REOCOR and EDP shall be inspected once a year and when malfunctions are suspected, as well as after improper use with HF surgical devices or defibrillators.

1.3. Standards, Laws and Regulations:

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

This inspection document fulfills the requirements of the european directive: • 2007/47 EU changes of directives 90/385/EWG and 93/42/EWG from 5. Sept. 2007 as well as the national laws and regulations of the members of the EU that are derived from the directives above. For Germany: • Gesetz über Medizinprodukte – MPG (Medical Device Act): Verordnung über das Errichten, Betreiben und Anwenden von Medizinprodukten – MPBetreibV (current revision). Furthermore the EN standard: Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007)

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Production and Inspection Specification

FPV-123-965 Rev. B

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1.4. Measuring Devices, Accessories, Aids, Calibration List of measuring devices, accessories and aids necessary for the inspections: •

• • • • • • •

Measuring device for leakage current and appropriate cables or a measuring system for leakage current and electrical safety (e.g. „Bender Unimed 1100 ST“; for measurement of leakage current according to IEC 62353) Metal foil /-plate 30 x 30cm (12’’ x 12’’), crocodile clamps, cables Oscilloscope Signal generator Power supply Voltmeter Resistor decade (10 Ohm to 10 kOhm) Resistor 470 Ohm (± 10%, only for dual chamber devices)

All devices used for the electrical inspection have to meet the specified tolerances (proved by documents of a valid calibration). All devices without measuring function are not subject of calibration (signal generators).

1.5. Records

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The inspection measurements and results have to be documented on the inspection record form (see last page, make copies if needed).

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Production and Inspection Specification

FPV-123-965 Rev. B

2.

Page 5/15

Inspection

2.1. Visual Inspection 2.1.1.

Housing • • • • • • • •

• •

2.1.2.

•

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The protection cover against unintentional changing of the control settings shall be present, without damages and easily movable. It shall have a limit stop that prevents the cover from being removed and a snap position when being closed completely. The protection cover shall not touch the setting dials.

Setting Dials • •

2.1.4.

The sticker for the battery orientation in the battery compartment shall be legible and intact. There shall not be any loose parts within the housing (prove by gently shaking the device).

Protection Cover (transparent plastic cover) •

2.1.3.

The housing shall not show any cracks, holes, delamination or deformation. All set screws visible from the outside shall be present and fixed. Only applicable to REOCOR: The seal of the set screw for the fixing strap shall be fixed and glued. The inscriptions shall be legible. The labeling for the device type shall be present, legible and fixed. The battery compartment shall be without damages, contamination or corrosion. It shall be easily closable. Only applicable to EDP: The battery retaining spring shall not be deformed and shall be free elastic pushable. Only applicable to EDP: The cover of the battery contact terminals (see fig. below) shall be mounted, fixed and free of damages.

The setting dial for the "Mode" shall have distinct steps when switched. All other setting dials shall rotate smoothly.

Connectors/Sockets • •

The connectors and sockets for stimulation/detection (with and without mounted adapters) shall be undamaged. An appropriate patient cable shall be easily connectable and detachable.

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Production and Inspection Specification

FPV-123-965 Rev. B

Page 6/15

2.2. Inspection of the Electrical Safety 2.2.1.

Protective Earth Resistance The devices REOCOR and EDP are not Class I devices (according to IEC 62353). Thus, the measurement of the protective earth resistance is not applicable.

2.2.2.

Measurement of the Applied Part Leakage Current (Battery Powered) Measuring devices, accessories and aids: Measuring device for leakage current and appropriate cables or a measuring system for leakage current and electrical safety (e.g. „Bender Unimed 1100 ST“; for measurement of leakage current according to IEC 62353); Metal foil /-plate 30 x 30cm (12’’ x 12’’), crocodile clamps, cables.

Test setup: The test setup shall be according to IEC 62353 “Measurement of the applied part leakage current with internal electrical power source, direct measurement” (see fig. 2.2.2-1).

Application part

Contact metal foil/-plate

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

fig. 2.2.2-1: Test setup according to IEC 62353 “Measurement of the applied part leakage current with internal electrical power source, direct measurement”

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Production and Inspection Specification

FPV-123-965 Rev. B

Page 7/15

Execution of the measurements: Place the device on the metal foil/-plate. Switch on and wait until the device is ready for use. Interconnect all contacts of the patient cable.

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The applied part leakage current is measured between the interconnection of the patient cable contacts and the metal foil/-plate with the aid of a auxiliary mains voltage (Measuring device for leakage current (“MD” in fig. 2.2.2-1) and appropriate cables or a measuring system for leakage current and electrical safety).

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Production and Inspection Specification

FPV-123-965 Rev. B

2.2.3.

Page 8/15

Insulation Resistance

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The measurement of the insulation resistance is not applicable to devices REOCOR and EDP.

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Production and Inspection Specification

FPV-123-965 Rev. B

2.3.

Page 9/15

Functional Test The “low battery” indicator shall never show up during and after the functional test. Inserting a fresh battery is recommended.

2.3.1.

Self Test Switch on the device and wait for the device to be ready for use. In case of a failure all lights are flashing and an audible tone is noticeable. Note: Each time the devices REOCOR and EDP are switched on they execute an automatic self test routine. This self test includes a check of internal components, modules and functions. In addition this self test is the basis for the further performance tests described in this document.

The self test routine checks the following aspects: Consistency of the Software:

The memory check sum is verified

Memory:

The RAM part of the memory is subject of a write/read check

Software monitoring:

The watchdog timer is tested

Stimulation/Detection:

Internal test of these functions

Run-Away-Protection:

The limitation of the upper pacing rate is tested

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

In case of a failure all lights are flashing and an audible tone is noticeable.

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Production and Inspection Specification

FPV-123-965 Rev. B

2.3.2.

Page 10/15

Detection The function of the detection (Sense) is tested by means of a signal generator (in addition maybe a divider by resistors). Test pulses are applied to the patient connector of REOCOR/EDP. Depending on the settings of the detection sensitivity of the device REOCOR/EDP the successful detection of the signal will be shown by blinking lights.

Measuring devices, accessories and aids: Signal generator (rectangle, the slew rate of the voltage shall be >10V/s), divider by resistors if applicable •

Settings at the signal generator: Signal form: Frequency: Amplitude:

Rectangle 1,5 Hz In order to achieve an amplitude (peak to peak) on the patient connector of the device of 10mV (Upp = 10mV, see fig. 2.3.2-1, ± 5%).

Upp

fig. 2.3.2-1: Signal form for the detection test

Attention: The amplitude and shape of the signal at the patient connector of the device shall be verified with the aid of an oscilloscope.

•

Settings at REOCOR/EDP: DDD (dual chamber) or VVI (single chamber) 60 ppm

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

Mode: Frequency:

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Production and Inspection Specification

FPV-123-965 Rev. B

Page 11/15

Execution of the measurement of the ventricular detection (dual chamber device) or detection (single chamber device): Switch on and wait until the device is ready for use. The test signal (rectangle, 10mVpp) is applied to the different and indifferent patient connector of the (ventricular) channel. This will be achieved by settings on the signal generator and/or appropriate resistors (voltage divider). The sensitivity of the (ventricular) detection is set to 20mV. The light for the (ventricular) detection shall not light up. Thereafter the sensitivity of the (ventricular) detection is set to 5mV. The light for the (ventricular) detection shall light up and the light for the (ventricular) pacing shall not light up.

Execution of the measurement of the atrial detection (only dual chamber devices): Switch on and wait until the device is ready for use. The test signal (rectangle, 10mVpp) is applied to the different and indifferent patient connector of the atrial channel. This will be achieved by settings on the signal generator and/or appropriate resistors (voltage divider).

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The sensitivity of the atrial detection is set to the lowest sensitivity (10mV). The light for the atrial detection shall not light up. Thereafter the sensitivity of the atrial detection is set to 2mV. The light for the atrial detection shall light up and the light for the atrial pacing shall not light up.

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Production and Inspection Specification

FPV-123-965 Rev. B

2.3.3.

Page 12/15

Stimulation The function of the stimulation is tested by means of an oscilloscope. Depending on the settings of the REOCOR/EDP an appropriate stimulation signal is measured. The signal light for stimulation (“pace”) shall light up.

Measuring devices, accessories and aids: Oscilloscope, resistor 470 Ohm (± 10%). •

Settings at the oscilloscope: According to the amplitude that is measured

•

Settings at REOCOR/EDP: Mode: Rate: Amplitude:

D00 (dual chamber), V00 (single chamber) 60 ppm REOCOR 3V and 17V, EDP 3V and 10V

Test set-up: Oscilloscope

Different Patient Connector REOCOR/EDP, channel under test (ventricle/atrium) 470 Ohm (± 10%) Indifferent Patient Connector REOCOR/EDP, channel under test (ventricle/atrium)

Execution of the measurement of the stimulation signal: Switch on and wait until the device is ready for use. The amplitude setting at the device REOCOR/EDP of 3V (REOCOR/EDP) and 17V (REOCOR)/10V (EDP) shall be measured at the patient connector of the appropriate channel (see Ua in fig. 2.3.3-1, tolerance of the amplitude = ±10%).

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

The indicator light(s) for pacing shall flash every second. An audible signal shall be heard every second.

fig. 2.3.3-1: Stimulation pulse, amplitude

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Production and Inspection Specification

FPV-123-965 Rev. B

2.3.4.

Page 13/15

Test of the Lead Impedance Monitoring The function of the lead impedance monitoring is tested by means of resistors applied to the patient connectors of the device REOCOR/EDP.

Measuring devices, accessories and aids:: Resistor decade (required values of 91, 220, 1800 and 3300/9100 Ohms; ± 5%) or appropriate individual resistors (± 5%); in case of a dual chamber device an additional resistor of 470 Ohms (± 10%). •

Settings at REOCOR/EDP: Mode: Amplitude:

DDD >1V

Test set-up:

Different Patient Connector REOCOR/EDP, channel under test (ventricle/atrium) Value according to the execution of measurements Indifferent Patient Connector REOCOR/EDP, channel under test (ventricle/atrium)

Execution of the test of the lead impedance monitoring: Switch on and wait until the device is ready for use. A resistor is applied to the different and indifferent patient connector of the channel under test (atrium or ventricle). This resistor is varied according to the values above. In case of the dual chamber device the other channel (that is not under test) has to be connected to a resistor of 470 Ohms.

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

At a resistor value of 91 and 3300 Ohms (REOCOR) or 91 and 9100 Ohm (EDP) an audible signal shall be noted. At a value of 220 and 1800 Ohm an audible signal must not be heard.

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Production and Inspection Specification

FPV-123-965 Rev. B

2.3.5.

Page 14/15

Test of the Battery Monitor EDP: The battery monitor (“low battery”) of the device EDP is tested by means of an adjustable power supply and a voltmeter. The battery of the device EDP is replaced by the output voltage of the power supply Measuring devices, accessories and aids:: Power supply (continuously adjustable and with integrated voltmeter or additional voltmeter), output voltage tolerance ± 5%); resistor of 470 Ohms (± 10%); in case of a dual chamber device an additional resistor of 470 Ohms (± 10%).

Execution of the test of the battery monitor: In order to avoid the “high lead impedance warning” a resistor of 470 Ohms is applied to the different and indifferent patient connector (in case of a dual chamber device at both channels). Switch on and wait until the device is ready for use. A test voltage is applied to the battery connectors of the EDP. Please note: Do not damage the contact cover (see chapter 2.1.1) and pay attention to the correct polarity of the test voltage. The test voltage is set to 9V and the slowly reduced (app. 0.1V/s). At least at a voltage of 5.9V and lower the “low battery” indicator shall start blinking.

REOCOR: The battery monitor of the device REOCOR is tested by removing the battery and measuring the time for discharge of the internal buffer capacitor. A fresh battery shall be connected to the REOCOR 3 hours in advance of the test in order to fully charge the internal buffer capacitor. Measuring devices, accessories and aids: Resistor of 470 Ohms (± 10%); in case of a dual chamber device an additional resistor of 470 Ohms (± 10%).

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

Execution of the test of the battery monitor: Switch on and wait until the device is ready for use. The device REOCOR is set to V00/30ppm/3V. In order to avoid the “high lead impedance warning” a resistor of 470 Ohms is applied to the different and indifferent patient connector (in case of a dual chamber device at both channels). Then open the battery compartment during operation of the device. The red indicator light for “low battery” shall start blinking. The indicator light for stimulation shall go out after >30s and <120s.

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Production and Inspection Specification

FPV-123-965 Rev. B

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Inspection Record (according to IEC 62353) Operating organization of the medical device under test (physician, hospital, address):

Medical device under test: Manufacturer:

Type:

Name:

Serial number:

Registration number:

Organisation of inspection:

Measuring devices: Measuring device for leakage current

Oscilloscope

Signal generator

Voltmeter

Type: Name: Serial number: Registration number:

Inspection: Test step

Comments/ Measured value

fail

pass

Measured -

50µ µA 1

____ µA

-

-

2

Max.

Visual inspection Housing, protection cover, setting dials, Connectors/Sockets

Inspection of the electrical safety Applied leakage current

Functional test Self test Detection Stimulation Lead impedance monitor Battery monitor

FOR-111-003-F / GPA-111-005 / CRQ-09-00825

Overall assessment:

Date Inspector (name) Date the of next inspection:

1 2

-

Inspector (signature)

Maximum value for the leakage current: ref. to EN 62353, table „Allowed values for leakage current“, „applied part leakage current“, type „CF“ At an overall assessment of „fail“ the device must not be used anymore

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