CardioScreen 1000 Device Manual

Transcription

1 CardioScreen 1000 Device Manual 0197 Tel info@medis-de.com Medizinische Messtechnik GmbH Fax W.-v.-Siemens-Str. 8, D Ilmenau Germany

2 CardioScreen 1000 Device Manual Copyright 2013 medis. Medizinische Messtechnik GmbH, Ilmenau, Germany Document revision 1.4

3 The complete documentation of the CardioScreen 1000 device consists of: Device Manual Software Manual Cardio Vascular Lab Before using the CardioScreen 1000 device read both manuals carefully and completely to ensure that you operate the system correctly. The CardioScreen 1000 device works computer supported. The Software Cardio Vascular Lab is required. When you set up the device for the first time, check to see if it has suffered any damage during transportation. According to the Medical Device Directive (MDD) the Cardio- Screen 1000 device belongs to class IIa and, therefore, is not intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient. The Federal law requires that the CardioScreen 1000 device should be used only by or on the order of a physician. Generally, all persons using the device must be qualified and understand the measuring method and the operation of the device. 2

4 If you need additional information or if you have any technical, methodical or clinical questions please contact: medis. Medizinische Messtechnik GmbH Werner-von-Siemens-Strasse 8 D Ilmenau Germany Tel Fax support@medis-de.com In the case of a request we would ask you to inform us about the serial number of your device which you can find on the type plate on the back or bottom side of the device. In case of a software request the serial number of the software is needed which can be found in the Hardware-Info screen. Press F5-Options in the Patient data screen and then the F1-Hardware button. 3

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6 Table of contents 1 Introduction Applications Precautions and limitations Safety requirements Explanation of used symbols Description of the device Commissioning of the device and preparing a measurement Maintenance Safety tests Cleaning and disinfection Technical data Scope of delivery medis Standard / Extended Warranty Troubleshooting Annex Manufacturer guidelines and declarations Commissioning of medical systems Test report for medical systems

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8 1 Introduction 1.1 Applications The CardioScreen 1000 device is used for non-invasive haemodynamic measurements and monitoring of haemodynamic parameters using methods of impedance cardiography (ICG). In impedance cardiography, pulse synchronous variations of the blood flow and volume in the thoracic aorta are determined and used for calculating different haemodynamic parameters. More specifically, with each beat of the heart, the volume and velocity of blood in the aorta changes. This produces a change in the electrical resistance (impedance) of the thorax to electrical alternating current. The change in impedance over time can be used to calculate stroke volume and several other important haemodynamic parameters. The CardioScreen 1000 device uses four dual sensors, which are placed on the patient s neck and thorax. The most upper and lower gel pads of these sensors (the outer sensors) are used to apply a very low constant and alternating current (1.5 ma, 86 khz) which is imperceptible to the patient. The other four gel pads are used to receive the applied current and ECG signal. The ACM (Arterial Compliance Modulation) earlobe-sensor provides additional information about the aortic compliance to improve the parameters measured with ICG: Note that the ECG measured with the ICG-channel is not a standard lead and is for triggering purpose only. It is not intended for diagnoses of any kind. 7

9 Different terms are used interchangeably when discussing impedance cardiography, electrical bioimpedance or thoracic electrical impedance (TEB). In this manual the term impedance cardiography or ICG is used. Impedance cardiography allows the measurement of following haemodynamic parameters: Thoracic fluid content (inverse to thoracic basic impedance) Pre-Ejection Period Left Ventricular Ejection Time Indexes of contractility: Velocity Index, Acceleration Index Heart Rate Following parameters can be calculated: Stroke Volume, Cardiac Output Heather Index Systolic Time Ratio Systemic Vascular Resistance (requires blood pressure value) Left Cardiac Work (requires blood pressure value) With reference to body surface area the following indexed parameters can be calculated: Stroke Volume Index, Cardiac Index Systemic Vascular Resistance Index Left Cardiac Work Index The CardioScreen 1000 device can be used for following clinical applications: Non-invasive monitoring of the above haemodynamic parameters including trend analysis Determination and checking of the haemodynamic state of a patient including management of heart failure and hypertension therapy Cardiologic diagnosis using haemodynamic parameters and waveform shape analysis Optimisation of pacemaker settings Additional information and a detailed description of the measuring method, the parameters, the application of impedance cardiography, and its limitations are given in the Software Manual. 8

10 1.2 Precautions and limitations The measuring device allows the examination of adult patients in a resting position. The measured parameters can be used only if the ECG and ICG waveforms have sufficient signal quality and are without artefact. If the waveforms are of questionable quality, display the Waveform screen and ensure that the key reference markers on the waveforms are accurately placed. Note the hints in the Software Manual. The method of impedance cardiography (ICG) is based on a theoretical model of blood flow movement in the thorax (aorta). If the physiological and clinical conditions of the patient are not in accordance with the assumptions of the model, inaccuracies in the parameters may occur (see section Basics of the methods: Impedance Cardiography (ICG) in the Software Manual). The following conditions may adversely affect the accuracy of ICG systems and are relative contraindications for the use of ICG systems: Septic shock Aortic valve regurgitation and defect of septum Severe aortic sclerosis, aortic prosthesis Severe hypertension (MAP > 130 mmhg) Cardiac arrhythmia Tachycardia with a heart rate higher than 200 bpm Patient heights below 120 cm (48 ) or above 230 cm (90 ) Patient weights less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.) Patient movement Aortic balloon or aortic balloon pump Simultaneous use of electrical cautery systems during surgical procedures During operations on the opened thorax the current distribution can be distorted and can lead to inaccuracies. The device is designated to monitor adults. When measuring infants and neonates the measuring results might not be reliable because only insufficient experiences exist for this group of patients. 9

11 1.3 Safety requirements According to the Medical Device Directive (MDD) the measuring device belongs to class IIa and, therefore, is not intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient. The Federal law requires that the measuring device should be used only by or on the order of a physician. Generally, all persons using the device must be qualified and understand the measuring method and the operation of the device. The measuring device can only be used in combination with a PC or a notebook and a printer. This constitutes a medical system device, which must be in accordance with the standard IEC It must especially be ensured that the leakage current does not exceed safety standards (also under failure conditions). This must be measured and filed. More information can be found in the section Commissioning of medical Systems. If the limits are exceeded special arrangements have to be taken. For instance, an isolating transformer with an insulation voltage of 4 kv can be used. For the compliance with these requirements the installer of the system is responsible. The measuring device belongs to the application class BF (Body Floating). Therefore, the sensors can be freely placed on the body surface. A direct contact with the heart or vessels is not allowed. Only connect one patient at the same time to the device. The sensors must not have a direct contact to other electrically conductive materials. Because of hygienic reasons only disposable electrodes/sensors should be used. Before monitoring patients with pacemakers, ensure that the function of the pacemaker cannot be influenced by the measuring current used for impedance cardiography. In the case of minute ventilation pacemakers the use of the ICG device is not allowed if the minute ventilation function of the pacemaker is activated. The device is not intended to be used while exposing the patient to high frequency current. 10

12 Handle the patient cable and lead wires carefully and position them so that they do not cross over each other or other cables or power cords to avoid signal interference. Do not expose the cables to mechanic or thermic impact. Avoid temperatures above 40 C (100 F). The measuring unit should neither be placed on a surface, which emits heat nor exposed to direct sunlight. The device is not protected against splashing water. Therefore, do not operate in bathrooms or other areas where water damage is possible. The device is not protected against explosive substance. Therefore, do not use the measuring device in the presence of flammable anaesthetics or gases. The device is protected against accidentally ingress of liquids. Nevertheless, in case that water or other liquids ingress into the case, the device must be disconnected immediately. To ensure that the measurement system functions safely, do not subject it to high levels of humidity or to strong electrical or electromagnetic interference fields. To connect the measuring system to an external network a Medical network insulation module (N1107) is required. The direct connection of the measuring system to an external network is prohibited if a patient is connected to the measuring device. The combination of the measuring device with other medical devices is only allowed if any harm to the patient can be excluded. The measurement system must always be kept in safe and reliable working order and must be checked regularly. The ICG channel is protected against cardiac defibrillations. No preparation is needed before the application of the defibrillator. The device will return to the standard operation within 10s after discharge. 11

13 1.4 Explanation of used symbols Caution, consult accompanying documents! Do not dispose with residual waste Device type BF, Defibrillator-proofed Insulation class II USB-Connector 12

14 2 Description of the device The following illustration shows the front side of the device: 1. USB connection cable 2. Status LEDs 3. ICG patient cables and ACM connector socket The USB-interface (1) may only be connected to computers and must not be connected to other medical devices. Ensure that the ACM sensor is connected with the device. Otherwise the measurement can not be started. The type plate is located on the back side and lists important information about the device, including the serial number. This number is required to obtain technical service assistance and warranty repairs. The device can only be operated if connected to the USB interface of an external computer with installed PC software Cardio Vascular Lab. The power supply is provided via USB interface. Located on the front side there is a green and orange indicator LED (2) which gives information about the device. Depending on the current status the following can be indicated: 13

15 green orange Description of function The device is disconnected or the PC is switched off (no voltage on the USB port) Device is ready to use, but the measurement has not been started Measurement is running; sensor contact is good Bad contact between sensors and patient: at least one lead wire is disconnected or not properly fixed; sensors are too dry (eventually new sensors are necessary) Insufficient contact between sensors and patient: at least one lead wire is disconnected or not properly fixed; sensors are too dry (new sensors are necessary) Device has power but no access to the software (e.g. if the software is not started yet) Legend: LED off LED flashing LED on 14

16 3 Commissioning of the device and preparing a measurement To place the measuring device into operation carry out the following steps: 1. The device should be placed near the patient and fixed in such a way that the device cannot fall down if someone pulls on the cables. Note that all devices, which are placed in the patient environment of 1.5 m must meet the requirements of the MDD (see also section Safety requirements ). 2. It is necessary to install the Cardio Vascular Lab software before connecting a device to the PC the first time (see section Installation of the PC-Software in the software manual). The required USB drivers will be installed during software installation. 3. Connect the device with the computer using the USB interface. 4. Place the ACM earlobe-sensor and the ICG sensors to the patient and connect them to the device. For more information see the Cardio Vascular Lab software manual section Impedance Cardiography (ICG). 5. Launch the software and choose the type of measurement. Before starting the measurement, the patient data must be entered. Please note also the hints in the Software Manual. 6. At the end of the measurement, go back to the patient data screen in the software and stop the measurement before switching off the device and removing the applied parts from the patient. 15

17 4 Maintenance 4.1 Safety tests The measuring device is a self-calibrating system so that external calibration is not necessary. The proper function of the system can be checked using a special signal generator (part no. N1104). The measurement system must always be kept in safe and reliable working order and should be checked regularly, at least once a year. The check should cover a function test and the measurement of leakage currents. If you discover that the measurement system is faulty and/or unsafe (for example, if any of the lines have insulation or breakage defects), repair the system and/or replace faulty cables immediately. Repairs may only be carried out by persons or workshops authorised to do so by the manufacturer. Otherwise, general liability for improperly operating the measurement system and for injury, damage and consequential damage resulting therefrom will be passed on to the operator or to the persons or workshops that have not been expressly authorised by the manufacturer. 4.2 Cleaning and disinfection It is recommended to clean and to disinfect the device and its cables regularly. Warning! Disconnect the device before cleaning or disinfection. Clean the device and the cables with a soft cloth. Do not use any abrasive or corrosive substances. We recommend neutral cleaning agents or disinfecting substances, like ethanol (70 80 %), propanol (70 80 %) or aldehyde (2 4 %). Ensure that no disinfectant gets onto the contact points of the plugs and sockets, and that no liquid seeps into the device. Caution! Never gas-sterilise the patient cables. They are covered with a PVC shroud that can react with the gas-sterilisation procedure to form a highly toxic ethyl nitrite. Sterilisation in an autoclave, with ultrasound or gamma rays is also not permitted. 16

18 5 Technical data Mains Supply via USB: 4,75V - 5,25V Supply frequency Direct current Power input < 1,5 W Electrical safety IEC (EN ) MDD class IIa Insulation class II Classification for patient protection BF Electromagnetic compatibility Insulation voltage EN class B EN Patient - Signal I/O: 4 kveff ; 1 min; 50 Hz Dimensions (W x H x D) Weight 75 x 25 x 130 mm approx. 130 g Signal I/O USB interface Transport and storage conditions Temperature: 0 50 C Humidity: % (non condensing) Altitude: m Operating conditions Temperature: C Humidity: % (non condensing) Altitude: m 17

19 ICG - Impedance Cardiography Measuring principle Sensors Measuring current Basic impedance Pulse wave Bioimpedance-Plethysmography defibrillator safe 4 medis-z-tect disposable sensors (solid gel) 1.5 maeff; 85 khz; Sinus 0 60 Ω; Hz ±1 Ω; Hz ECG Max. input voltage ±10 mv AC voltage defibrillator safe Frequency range Common mode rejection ratio Hz > 90 db Noise voltage < 10 µv 18

20 6 Scope of delivery To the scope of delivery of the measuring device CardioScreen 1000 the following components belong: Measuring device CardioScreen 1000 ACM sensor CardioScreen 1000 Device Manual Software manual Cardio Vascular Lab Software-CD Cardio Vascular Lab The necessary computer is not a component of the scope of delivery. Please consider the safety-relevant requirements in section Safety requirements. If you have any question our support is at your disposal. Accessories and expendable items medis-z-tect sensors (part number N1201-5) ACM sensor (N1314) ICG / ECG simulator for function control of the measuring system (N1104) Medical network insulation module (N1107) 19

21 7 medis Standard / Extended Warranty medis Medizinische Messtechnik GmbH ( medis ) warrants that the measuring System ( System ) and the System Software ( Software ) shall be free from errors / defects in materials, workmanship, and programming that cause the System not to function in accordance with the accompanying written specifications provided with the System at the time of installation. medis will provide this Standard Warranty on each System for a period of thirteen (13) months from the original medis invoice date. This Standard Warranty shall exclude the System external patient cable(s) and (if applicable) the external inflatable blood pressure cuff(s), hose(s) and sensors, which shall be covered under warranty for ninety (90) days from the original medis invoice date. medis and/or its Distributors liability and obligation, and the End User s sole remedy shall be, at medis option, to either repair or replace software and/or System or any part thereof. It is the responsibility of the End User to notify medis or medis Distributor (if medis requests the End User to notify its Distributor) by telephone or in writing of any problem experienced by the End User within the thirteen (13) month Standard Warranty Period and no later than thirty (30) days after the expiration of the warranty period. This Standard Warranty does NOT apply to dual sensors, fuses, ink cartridges or other consumable or disposable items that are used in conjunction with the System. An Extended Warranty is available for sale, which provides the same warranty coverage as the Standard Warranty in twelve (12) month increments. Under Extended Warranty, the System external patient cable(s) and (if applicable) external inflatable blood pressure cuff(s) and hose(s) are not covered. Standard / Extended Warranty Coverage: Customer / Technical Support is available Monday through Friday, 8 a.m. to 5 p.m. German Time, at medis will repair or replace any components of the System that cause the System to not function in accordance with the written materials provided with the System at time of sale. medis will provide free shipping and freight charges for warranty repairs performed at medis or a medis Authorised Service Centre. medis will provide subsequent operational software upgrade disks and installation instructions at no charge to the customer. 20

22 Standard / Extended Warranty Service is void if: The System and/or Software has been maintained, repaired, modified or altered by any person other than an authorised medis representative or without prior approval from an authorised medis representative. The System and/or Software has not been properly operated or maintained in accordance with medis then applicable written operating and maintenance manuals. The configuration of the System and/or Software has been altered by, but not limited to, the addition of any other computer software to the System. The failure of the System and/or Software has resulted from accident, abuse, or misapplication. Note: There are no user-serviceable components in the measuring system. All units must be returned to medis or a medis Authorised Service Centre for repair or replacement. medis does not warrant (either expressed or implied) the correctness or validity of any output information or data provided by the System, including, but not limited to, any information relating to any medical diagnosis/treatment or to the health and safety needs of patients. medis does not warrant that any output of the System will meet the standards or requirements of the End User s medical practice. End User expressly acknowledges that End User is solely responsible for verifying that any results produced by the System are free from error and suitable for the applications for which they are to be used. medis and its authorised Distributors shall not be liable for any special, incidental, indirect or consequential damages arising out of the use of or inability to use the System. Under no circumstances shall medis and its Distributors liability under this Limited Warranty exceed the purchase price of the System and/or Software paid by the End User. 21

23 8 Troubleshooting The following overview serves for fast diagnosis and remedy of smaller problems. If a problem should exist further, then please contact your dealer or the technical support. The status indicator LEDs of the CardioScreen 1000 are off. Check if the device is probably connected to the USB-port of the PC and that the PC is switched on. If necessary use a different USB-port of the PC. A measurement cannot be started because the button F9 - Start in the software is disabled (grey). The software did not find the CardioScreen 1000 device. Please check, if: the examination type ICG is selected the USB cable is connected correctly the ACM sensor is connected to the CardioScreen 1000 The examination type ICG is not available or can not be selected. The serial number of the PC software is wrong. Please click onto the button F5 - Options in the Patient data screen and compare the serial number in the program with the serial number which is printed on the delivered software CD. 22

24 9 Annex 9.1 Manufacturer guidelines and declarations Electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/flicker emissions IEC Group 1 Class B Complies Complies Electromagnetic environment guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) ±6kV contact ±6kV contact Floors should be wood, concrete or ceramic tile. If floors are cov- 23

25 IEC ±8kV air ±8kV air ered with synthetic material the relative humidity should be at least 30 %. Electrical fast transient / burst IEC ±2kV for power supply lines ±1kV for input/output lines ±2kV for power supply lines ±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC ±1kV differential mode ±2kV common mode ±1kV differential mode ±2kV common mode Mains power quality should be that of a typical commercial or hospital environment. <5% UT (>95% dip in UT) for ½ cycle <5% UT (>95% dip in UT) for ½ cycle Voltage dips, short interruptions and voltage variations on power supply input lines IEC % UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. Power frequency (50 Hz) magnetic field IEC <5% UT (>95% dip in UT) for 5s 3 A/m 3 A/m <5% UT (>95% dip in UT) for 5s Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. 24

26 Electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d=1,2 P Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 Vrms 3 V/m d=1,2 P for 80 MHz to 800MHz d=2,3 P for 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,¹ should be less than the compliance level in each frequency range,² Interference may occur in the vicinity of equipment marked with the following symbol: 25

27 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ¹ Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. ²Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 26

28 Recommended separation distances Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the device The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter in meters 150 khz to 80 MHz d = 1,2 P 80 MHz to 800 MHz d = 1,2 P 0,01 0,11 0,11 0,23 0,1 0,37 0,37 0,75 1 1,2 1,2 2,3 10 3,7 3,7 7, MHz to 2,5 GHz d = 2,3 P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 27

29 9.2 Commissioning of medical systems Before commissioning of the device the combination of device, PC and additional peripheral devices must be tested and documented. If the system is not supplied completely by the manufacturer the tests must be performed by the distributor. Depending on the application electrical test have to be performed and documented in the Test report for medical systems. Application 1 Description CardioScreen 1000 is connected to the patient CardioScreen 1000 is connected to a computer via USB Only the CardioScreen 1000 is in the patient environment of 1,5m around the patient Additional requirements None Commissioning Documentation Application 2 Description CardioScreen 1000 is connected to the patient CardioScreen 1000 is connected to a computer via USB CardioScreen 1000 and computer are in the patient environment of 1,5m around the patient Computer is running on battery Additional requirements No network is connected to the computer (otherwise a network insulation must be used) Commissioning Documentation 28

30 Application 3 Description CardioScreen 1000 is connected to the patient CardioScreen 1000 is connected to a computer via USB CardioScreen 1000 and computer are in the patient environment of 1,5m around the patient Computer is connected to mains Additional requirements The computer is of protection class I (with protective earth connector) No network is connected to the computer (otherwise a network insulation must be used) Commissioning 29

31 Application 4 Description CardioScreen 1000 is connected to the patient CardioScreen 1000 is connected to a computer via USB CardioScreen 1000 and computer are in the patient environment of 1,5m around the patient Computer and peripheral devices are connected via a multiple socket outlet to mains Additional requirements Every device (except the CardioScreen1000) is of protection class I (equipped with a protective earth connector) No network is connected to the computer (otherwise a network insulation must be used) No standard connection cable fits into the multiple socket outlet or the connections are only accessible with a tool Commissioning 30

32 9.3 Test report for medical systems The medical system consists of: Tested by: CardioScreen 1000 Dev. No:... CardioScreen 2000 Dev. No:... Computer Type:... Printer Type:... Others Type:... Application 1 no additional measures necessary Application 2 no additional measures necessary Application 3 Earth leakage current (ELC): Highest touch current (TC): µa µa Measures taken: Isolating transformer installed (if ELC > 500 µa or TC > 100µA) Type: Application 4 Earth leakage current (ELC): (in multiple socket outlet) Highest earth leakage current (helc): (each device, only if ELC > 500µA) Highest touch current (TC): µa µa µa Measures taken: Isolating transformer installed (if helc > 500 µa or TC > 100µA) Type: Additional protective earth connection (if ELC > 500 µa, helc < 500 µa and TC < 100µA) Connected to: Comments: Test passed Test not passed Date Name of tester Signature 8 medis. Medizinische Messtechnik GmbH Werner-von-Siemens-Str. 8, Ilmenau, Tel / , Fax , 31