Operating Instructions SECULIFE⏐SR PC Controllable Instrument for Measuring Safety-Relevant Characteristic Values of Electrical (Medical) Devices 3-349-444-03 6/7.
Standard Equipment Scope of delivery 1 measuring instrument SECULIFE⏐SR 1 mains power cable (at the measuring instrument: via 16 A inlet plug – mains side: country-specific) 1 probe cable with test probe 1 plug-on alligator clip 1 CD-ROM with description of remote control Accessories (sensors, plug inserts, adapters, consumable materials) • Drum with 25 m probe extension cable • ECG connections • Test socket adapter • Calibration adapter • Brush probe • PS3 Software • Pouch, carrying case The accessories av
Contact Persons Recalibration Service We calibrate and recalibrate all instruments supplied by GMC-I Messtechnik GmbH, as well as by other manufacturers, at our service center, for example after one year within the framework of your test equipment monitoring program, as well as prior to use etc. (address see below). Repair and Replacement Parts Service Calibration Center* and Rental Instrument Service If required please contact: GMC-I Service GmbH Service Center Thomas-Mann-Str.
Table of contents Contents Page 1 1.1 Applications ..................................................................... 5 Classification of Devices Under Test .................................... 6 1.1.1 1.1.2 Protection Classes .........................................................................6 Applied Parts (electrical medical devices) ........................................6 2 Safety Features and Precautions ..................................... 7 3 Terminals ...........................
Applications and Classification of Devices Under Test 1 Applications The measuring instrument is intended for quick, safe measurement of repaired or modified electrical medical devices and their components (e.g. applications parts) in accordance with IEC 62353. Adherence to technical safety requirements assures safe handling of electrical medical devices for users of the measuring instrument. The safety of the patient is also assured during use of tested electrical medical devices.
Applications and Classification of Devices Under Test 1.1 Classification of Devices Under Test 1.1.1 Protection Classes Devices assigned to all of the following protection classes are equipped with basic insulation, and provide for protection against electrical shock by means of various additional precautions as well. Protection Class I Devices Exposed, conductive parts are connected to the protective conductor so that they are not charged with voltage if the basic insulation should fail.
Safety Warnings 2 Safety Features and Precautions This instrument fulfills the requirements of applicable European and national EC directives. This is confirmed by means of the CE mark. A corresponding declaration of conformity can be requested from GMC-I Messtechnik GmbH.
Safety Warnings • Power Consumers with High Inrush Current (> 16 A) – Function Test (e.g. fluorescent tubes, halogen lamps, headlights etc.): Observe the following instructions in order to prevent excessive contact loads. ! Attention! Starting the Function Test For reasons of safety, the device under test must be switched off before the function test is started. This precaution prevents inadvertent start-up of a device under test which may represent a hazard during operation, e.g.
Terminals 3 Terminals Jacks A through K for Applied Parts USB Slave, to PC A K Standard Socket (test socket) for connecting the DUT S1 Connections for Probe PGS10 (Z745Y) Connection S2 Connections for Probes Application Top Connections Standard socket Test socket Sockets A through K Applied parts connection USB-SI USB slave, to PC Mains Connection Fuses Insert the double plug of the probe into sockets 1 and 2 such that the plug with the white ring makes contact with socket 1 (silver ring).
Initial Start-Up – Setup 4 Initial Start-Up 4.1 Connection to the Mains (90 to 240 V, 50 to 400 Hz) ➭ Connect the mains plug at the measuring instrument to the mains power outlet. 4.1.1 Automatic Recognition of Mains Connection Errors The measuring instrument’s protective conductor connection is tested each time the start-stop key is pressed. If a voltage of greater than 25 V is detected between the protective conductor and the finger contact, no measurements are possible.
Local Operating Mode 5 Manual Test Manually Triggered Measurements Operating Mode Display – Remote: highlighted display – Local: display not highlighted (see below) Adjustable measuring parameters are displayed as softkeys. PRINT: Key for hardcopy functions (in preparation) DIR DIF ALT Direct measurement Diff. current measurement Alternative meas.
5.1 General Procedure Ð Select the main menu: MENU key. Ð Select a menu function: ↑↓ keys. Ð Depending upon the measuring function select either – Type of test current: DIR / DIF / ALT / DL key. or – Protection class and type of connection: PC1 / PC2 / FIX key. Ð Connect the device under test in accordance with the previously selected type of test current. Depending upon the type of test current, it may be necessary to use the probe.
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RPE Protective Conductor Resistance Measuring Method Resistance is measured: • Between each exposed conductive part of the housing which is connected to the protective conductor (probe contact) and the earthing contacts at the mains and the device plug (if a removable mains connector cable is used).
RPE Protective Conductor Resistance Measuring and Storing an Offset Value when Using a 2nd Probe When a second probe is used which is connected to sockets 3 and 4, 4-wire measurements are not provided for. However, the ohmic resistance of the cable for the second probe can be automatically deducted from the measuring result by determining an offset value. Please proceed as follows to this end: Ð Connect the two probes to sockets 1 and 2 or 3 and 4, respectively.
RINS Insulation Resistance Measuring Method Protection Class I (PC1) Insulation resistance is measured between short-circuited mains terminals and the protective conductor. Protection Class II (PC2) Insulation resistance is measured between short-circuited mains terminals and external conductive parts which can be contacted with the probe.
RINS Insulation Resistance PC1 Connection PC2 ConnectionI Note All switches at the device under test must be set to the on position during measurement of insulation resistance, including temperature controlled switches and temperature regulators as well. Measurement must be performed in all program steps for devices equipped with program controllers. Ð Start the test: Press the START⏐STOP key. ! Permanent connection Attention! Testing is conducted with up to 500 V.
IE Equipment Leakage Current (differential current – protective conductor current – fault current) Definition of Alternative Measurement (alternative equipment leakage current) Alternative leakage current is current which flows through the active conductors of the device which are connected to each other (L/N) to the protective conductor, or to the exposed, conductive parts and the applied parts. Direct Measurement Method The device under test is operated with mains power.
IE Equipment Leakage Current (differential current – protective conductor current – fault current) Equipment Leakage Current with the Direct Measurement Method Equipment Leakage Current with the Alternative Measurement Method The protective conductor is ineffective during measurement! Sequence Ð Select the test: ↑↓ keys. Ð Connect the DUT to the test socket. Ð Select type of test current: DIR / DIF / ALT key. Ð Select mains polarity reversal: L/N / N/L key. Ð Start the test: Press the START⏐STOP key.
IT Touch Current – Testing for Absence of Voltage Definition of Touch Current Leakage current that flows from the housing or parts thereof – with the exception of the patient ports – with which the user or the patient may come into contact during use for intended purpose, to ground or another part of the housing via an external connection, except for the protective conductor. Definition of Direct Measurement Current which flows through the probe in the case of housings which are isolated from ground.
IT Touch Current – Testing for Absence of Voltage Direct Measurement Method The device under test is operated with mains power. Current which flows to the protective conductor via exposed conductive parts is measured. The measurements must be performed with mains plug polarity in both directions. The AC or the DC component of the current is measured. The value which has been adjusted to nominal line voltage is displayed (see section 4.3).
IT Touch Current – Testing for Absence of Voltage Sequence DIR / DIF / ALT Ð Select the test: ↑↓ keys. Ð Connect the DUT to the test socket, or connect the probe. Ð Select type of test current: DIR / DIF / ALT key. Procedure for DL – 2-probe Measurement This measurement is performed with 2 probes. The measuring section is electrically isolated from the mains power supply of the instrument. Input resistance is 1 kΩ. Ð Select test: key ↑↓ Ð Select mains polarity reversal: L/N / N/L key.
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IP Patient Leakage Current When testing measuring instruments with several applied parts, each must be connected, one after the other, and measuring results must be evaluated on the basis of the limit values. Applied parts which are not included in the measurement must be kept potential-free. Definition of Patient Leakage Current Current which flows from power packs and exposed conductive parts of the housing to the applied parts. The AC and the DC component of the current is measured.
IP Patient Leakage Current Examples of Maximum Permissible Limit Values for Patient Leakage Current in mA IP Test Standard EN 60601 IEC 60601 3rd ed. Total Patient Leakage Current Type B DC Type BF Type CF NC SFC NC SFC NC SFC 0.01 0.05 0.01 0.05 0.01 0.05 AC 0.1 0.5 0.1 0.5 0.01 0.05 DC 0.05 0.1 0.05 0.1 0.05 0.1 AC 0.5 1 0.5 1 0.05 0.1 Sequence Ð Select the test: ↑↓ keys. Ð Connect the device under test to the test socket, and the applied parts to the patient ports.
IAP Leakage Current from the Applied Part (alternative patient leakage current, mains at applied part) tient ports for a type BF or CF applied part. Definition of Alternative Measurement Alternative patient leakage current is current which flows through the conductors of the device which are connected to each other (L/N/PE) to the patient ports.
IAP Leakage Current from the Application Part (alternative patient leakage current, mains at applied part) Mains Polarity Parameter Polarity can be reversed for measurements during which the mains are connected to the test socket. Note Can only be used for types BF and CF applied parts. Ð Select the test: ↑↓ keys. Ð Connect the device under test to the test socket and the applied parts to the patient ports. The test probe has to be connected but without applying electrical contact (potential-free).
Function Test with Line Voltage Measuring Method The device under test can be subjected to a function test with line voltage via the integrated test socket. The function test includes the following measurements: – Voltage ULN between the L and N conductors – Load current IL – Active power P – Apparent power S (calculated) – Power factor PF (calculated cos ϕ, display > 10 W) Power factor is calculated from active power and apparent power.
Function Test with Line Voltage Prerequisites • It is only permissible to execute the function test after the device under test has passed the safety test, i.e. all safety measurements must first be executed and passed. • The device under test must be connected to the test socket. If no device under test has been connected, momentary line voltage are measured if the measuring instrument is connected to the mains. • No short-circuits may exist at the DUT.
Technical Data 6 Technical Data Measured Quantity RPE Protective earth resistance RINS Insulation resistance Measuring Range Reso/ Nominal Range lution of Use Additional Info OpenCircuit Voltage U0 man: 1 ... 999 mΩ 1 mΩ man: 0.01 ... 9.99 Ω 10 mΩ Electronic 4.0 … 4.5 V auto: 0.01 ... 30.00 Ω 10 mΩ fuse + fuse AC TRMS link 10 mΩ 0.01 ... 3.30 Ω 0.1 ... 10.0 Ω 100 mΩ 10 ... 300 kΩ 0.01 ... 3.0 MΩ 0.1 ... 30.0 MΩ 1 ... 300 MΩ 10 kΩ 10 kΩ 100 kΩ 1 MΩ Test voltage: 500 V DC 2) UN < U < 1.
Technical Data Measured Quantity OpenAddi- ShortInt. Ref. Measuring Error Circuit tional Circuit Resist. Resist. Voltage Info Current RI RREF U0 IK Leakage Current Measurements – Differential Method (DIF) IE 10 ... 300 μA~ 1 μA = Protective earth current, direct IT 0.5 ... 20.0 mA: 0.01 ... 3.00 mA~ 10 μA Residual current monitoring < ±10% rdg. Residual current 0.1 ... 30.
Technical Data Ambient Conditions Operating temperature Accuracy range Storage temp. range Relative humidity Elevation Deployment 230 V ±0.2% 50 Hz ±0.1% Sine (deviation between effective and rectified value < 0.5%) +23 °C ±2 K 40 … 60% Linear 0 °C ... + 40 °C 0 °C ... + 40 °C – 20 °C ... + 60 °C max.75%, no condensation allowed max.
Technical Data Electrical Safety Fuses Safety class Nominal voltage Test voltage Measuring category Fouling factor Safety Shutdown 2 x FF (UR) 500 V/16 A AC; 6,3 mm x 32 mm; (Article number 3-578-215-01) 50 kA breaking capacity at 500 V AC Disconnection from mains per SC II 230 V 2.2 kV AC or 3.3 kV DC 300 V CAT II 2 With following differential current at DUT during: – Function test 10 mA~ / < 25 ms – Touch current meas. direct current meas. 10 mA~ / < 25 ms Residual current meas.
Maintenance – Calibration 7 Maintenance and Calibration 7.1 Housing Maintenance No special maintenance is required for the housing. Keep outside surfaces clean. Use a slightly dampened cloth for cleaning. Avoid the use of cleansers, abrasives or solvents. 7.2 Replacing the Fuses All fuses are accessible from the outside.
Maintenance – Calibration 7.4 Manufacturer’s Guarantee The measuring instrument SECULIFE⏐SR is guaranteed for a period of 1 year after date of shipment. The manufacturer’s guarantee covers materials and workmanship. Damages resulting from use for any other than the intended purpose, as well as any and all consequential damages, are excluded. Calibration is guaranteed for a period of 12 months. The manufacturer’s guarantee expires when the seal has been damaged. 7.
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Index 8 Index A Accessories ............................................................ 2 C Classification of Devices Under Test According to Application Part .........................6 According to Safety Class ..............................6 Configuring Device Parameters ........................... 10 Maintenance Housing ......................................................... 34 Manufacturer’s Guarantee ...................................35 Measuring Categories and their Significance .......
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Edited in Germany • Subject to change without notice • PDF version available on the Internet GMC-I Messtechnik GmbH Südwestpark 15 90449 Nürnberg • Germany Telefon+49 911 8602-111 Telefax +49 911 8602-777 E-Mail info@seculife.eu www.seculife.
