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REFA FAMILY USER MANUAL

 

 

Page 

3

 of 

27

 

 

1

 

SERVICE AND SUPPORT 

 

About this manual 

1.1

This  manual  is  intended  for  the  user  of  the  Refa  and  Refa  Extended  system 

– 

referred  to  as  ‘product’  throughout  this  manual.  It  contains  general  operating 
instructions, precautionary measures, maintenance instructions and information for 
use  of  the  product.  Read  this  manual  carefully  and  familiarize  yourself  with  the 
various controls and accessories before starting to use the product.  

 

Contact information TMSi 

1.2

TMSi  Support  can  be  reached  via  email  (

[email protected]

)  or  via  the  website: 

www.tmsi.com/support

Please provide as much information as possible, including 

serial numbers of the used products. This will help to support  you in the best way 
possible.  

TMSi Support can be contacted in one of the following languages:  Dutch, English 
or German. 

Manufacturer 

 

Contact Information 

Twente Medical Systems International B.V. 

Zutphenstraat 57 
7575 EJ Oldenzaal 
The Netherlands

 

 

[email protected]

 

 

www.tmsi.com 

 

 

 

Warranty information 

1.3

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 of 6 months. 

Repairs  can  only  be  performed  by  the  manufacturer  or  by  TMSi  authorized 
personnel.  Warranty  will  terminate  automatically  by  removal  or  alteration  of 
identification labels on the product or its parts. In case seals on the enclosure are 
broken  or  removed,  warranty  is  voided  and  TMSi  can  no  longer  guarantee 
continued safety or correct operation of the product. 

The warranty does not cover the following: 

 

Failure resulting from misuse, accident, modification, unsuitable physical or 
operating environment, or improper maintenance. 

 

Wear and tear caused by regular and normal usage and ageing of 
rechargeable batteries. 

 

Failure caused by a product for which TMSi is not responsible. 

 

Damage resulting from use of non-approved accessories. 

 

Uninterrupted or error-free operation of wired or wireless data 
transmission. 

Any  technical  or  other  support  provided  for  a  product  under  warranty,  such  as 
assistance  with  “how-to”  questions  and  those  regarding  device  set-up  and 
installation, is provided without warranty. 

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...

Страница 27: ...Copyright 2020 TMSi All rights reserved www tmsi com...

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