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REFA FAMILY USER MANUAL

Page

Additional accessories or spare parts

1.4

In case you want to order additional accessories such as cables or sensors or
spare parts such as power supplies, please contact

[email protected]

for

consultation and a detailed quotation.

Abbreviations

1.5

Abbreviation

AUX

Auxiliary

BIP

Bipolar

Conformité Européenne

Cardiac Floating

ECG

Electrocardiography

EEG

Electro-encephalography (Brain activity)

EM, EMC

Electro-magnetic, Electro-Magnetic Compatibility

EMG,
HD EMG

Electromyography (Muscle activity),
High-Density Electromyography,

EOG

Electro-oculography

Information Technology

Personal Computer

Serial Number

TMSi

Twente Medical Systems International B.V

USB

Universal Serial Bus

Содержание Refa

Страница 1: ...Refa Family REF 92 0121 0201 EN 1 0 REV 1 Last update 2020 04 03 USER MANUAL...

Страница 2: ...4 Disclosure of residual risk 8 2 5 3 PRODUCT OVERVIEW 9 Product components 9 3 1 Intended use 10 3 2 Refa views 11 3 3 User interface 13 3 4 Measurement connections 13 3 5 Trigger input 14 3 6 4 INST...

Страница 3: ...The product except its cables and accessories is warranted against failure of materials and workmanship for a period of 2 years from the date of delivery Cables and accessories have a warranty period...

Страница 4: ...ion Abbreviations 1 5 Abbreviation AUX Auxiliary BIP Bipolar CE Conformit Europ enne CF Cardiac Floating ECG Electrocardiography EEG Electro encephalography Brain activity EM EMC Electro magnetic Elec...

Страница 5: ...symbols used with the product Caution Attention read important safety information Important information guidance for use Consult instructions for use Device has type CF applied parts Keep dry symbol C...

Страница 6: ...quipment or equipment capable of emitting diagnostic levels of ionizing radiation Apart from the above there are no contra indications There are no known side effects from the use of this product Safe...

Страница 7: ...configuration is confirmed Do not immerse the product in any liquid The product is to be kept dry Do not expose the product to direct sunlight heat from a source of thermal radiation excessive amounts...

Страница 8: ...ptical fiber can introduce new risks that require additional analysis Changes to the IT network include changes to its configuration connecting additional items disconnecting items updates and upgrade...

Страница 9: ...this cable various other electrodes sensors and accessories may be delivered with the package Refer to the list of supported active sensors to see which are supported by the product 7 Power supply Pow...

Страница 10: ...e leads connected to a subject Other physiological parameters such as respiration body position body movement and temperature are measured using the auxiliary input channels These types of signals req...

Страница 11: ...ient Ground Patient Ground input 4 Unipolar measurement connections Input for unipolar measurement connections 6 Impedance LEDs When in impedance mode LED to indicate if impedance is lower than a user...

Страница 12: ...r Connector for external power supply of the system 3 8 bit trigger connector 8 bit trigger input DB25 trigger connector 4 ON OFF switch Switch to power the system 5 BNC input 1 bit trigger input BNC...

Страница 13: ...set by the application software Impedance error When the Impedance LEDs blink the requirements for correct impedance determination are not met See chapter 4 5 for instructions FUSBI Indicator On Syst...

Страница 14: ...The Refa has two trigger inputs A single bit BNC trigger input and an 8 bit TTL trigger input The trigger inputs can be used to record up to 8 TTL trigger signals on the digital channel of the Refa Th...

Страница 15: ...before installing new drivers TMSi PC Driver Start the installer by clicking setup exe The TMSi PC Driver Setup Wizard starts and guides you through the process of installation of the driver Follow t...

Страница 16: ...l light up green On the CSUPEMCA power supply you also have to switch on the power supply Position the power supply such that it is easy to disconnect the power supply from the mains Connect power cab...

Страница 17: ...ections Please note No hazardous situations have been identified for the product due to loss of the IT network functionality Setup of the Refa system seen from the front and back side Front view Back...

Страница 18: ...product or downloadable on www tmsi com In case you are not using TMSi Polybench but a different software package in combination with our products please refer to the User Manual of that software pac...

Страница 19: ...tage for measuring bipolar electrophysiological signals is configured as an instrumentation amplifier The difference between a plus and minus signal is amplified The Patient Ground electrode is requir...

Страница 20: ...fluids or submerge the product in liquids Never use sharp tools or aggressive chemicals for cleaning or disinfecting Do not sterilize the product Environmental protection Special EU instructions for d...

Страница 21: ...below The customer or the user of the Refa should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic d...

Страница 22: ...V 1 2 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 1 2 80 MHz to 800 MHz 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the tra...

Страница 23: ...stance according to frequency of transmitter m 150 kHz to 80 MHz 1 2 80 MHz to 800 MHz 1 2 800 MHz to 2 5 GHz 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For t...

Страница 24: ...nnels 3600 mm x 2100 mm x 73 mm Weight 8 to 72 input channels approximately 1625 g 136 input channels approximately 3000 g Regulatory Specifications Power source External mains power supply Mode of op...

Страница 25: ...V Leakage current 10 A Fuses SUP3 See label or manual of the SUP3 2 x T 0 5AH or 2 x T 1 0AH 250V 5x20mm CSUPEMCA 2 x T 1 25AH 250V 5x20mm To disconnect the power supply from the mains remove the plug...

Страница 26: ...itions Temperature 25 C to 70 C Humidity 15 to 93 Pressure 500 hPa to 1060 hPa Storage Conditions Temperature 0 C to 40 C Humidity 15 to 93 Pressure 500 hPa to 1060 hPa Usage Conditions Temperature 5...

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