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USER MANUAL SAGA

Page 5 of 47

SAFETY INFORMATION

This section contains general warnings, explanation of markings, limitations of use,

safety measures and precautionary measures important for safe use of the product.

Explanation of markings

This section explains the various markings and symbols used with the product.

Warning: read important safety information

Caution

Consult instructions for use

Type CF applied part

CE-certified, see declaration of conformity

Identification of the manufacturer

Year of manufacturing

Ingress protection rating

TMSi Type identification

TMSi reference number

TMSi serial number

Contains transmitter module

Contains radio module for which the Technical Regulations Conformity Certification has

been granted

Special EU instructions for disposal are applicable to a product on which this symbol is

placed. The Maintenance section of this manual contains information on how to dispose

of this product

Wired connection status indicator; see chapter 3.3

Wi-Fi connection status indicator; see chapter 3.3

On-board memory status indicator; see chapter 3.3

Signal Mode status indicator; see chapter 3.3

Battery status indicator; all status indicators are explained in chapter 3.3

Stand-by symbol

Power status indicator; all status indicators are explained in chapter 3.3

Remote Interface status indicator; all status indicators are explained in chapter 3.3

Содержание Saga 32+

Страница 1: ...REF 92 1000 0201 0 1 0 REV 1 EN Last update 2019 06 13 USER MANUAL...

Страница 2: ...Docking Station 21 Power the Data Recorder 21 Charge batteries 22 Docking mechanism 22 Connect accessories 23 Data connections 24 Software 25 SAGA Bracket 26 5 Perform a measurement 27 Perform Statio...

Страница 3: ...st 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...

Страница 4: ...Out Box CF Cardiac Floating CE Conformit Europ enne DS Docking Station DR Data Recorder EEG Electro encephalography Brain activity EM EMC Electro magnetic Electro Magnetic Compatibility EMG HD EMG Ele...

Страница 5: ...er TMSi serial number Contains transmitter module Contains radio module for which the Technical Regulations Conformity Certification has been granted Special EU instructions for disposal are applicabl...

Страница 6: ...any other than the designated battery type with SAGA to avoid the risk of electric shock and damage to it Do not use SAGA together with cautery or electro coagulation equipment on the same subject to...

Страница 7: ...AGA is not defibrillation proof equipment To avoid damage to it disconnect it fully from the subject before applying defibrillation shocks In order to isolate SAGA from the supply mains disconnect the...

Страница 8: ...the device There are no restrictions on the subject population where the product can be used on The product can be used on subjects regardless of age gender or other criteria Subject interface and op...

Страница 9: ...n of the acquired signal data Use environment and conditions of use The product is intended for use on humans in a research laboratory or home environment only the Data Recorder within environmental l...

Страница 10: ...ata either via streaming or through retrieval of ambulatory recording However disturbances such as mains power glitches and interference in wireless transmission may cause transient loss of streamed s...

Страница 11: ...ocking Station 4 Fiber connector behind cover 5 Status indicator window Front View Marking Description 1 AUX 1 3 Auxiliary input connectors 2 BIP 1 2 3 4 Bipolar input connectors 3 GND Patient Ground...

Страница 12: ...1 Gutters for docking on the SAGA Bracket 2 Device label 3 Dock security ribbon for SAGA Bracket Data Recorder Description 1 Docking connector contact points 2 Gutters for docking on the Docking Stat...

Страница 13: ...cover 4 Docking Station USB status indicator 5 Docking Station USB connector 6 Docking Station Ethernet status indicator 7 Docking Station Ethernet connector 8 Docking Station Power status indicator...

Страница 14: ...ton 5 Docking Station Fiber cover 6 Data Recorder UNI 1 32 multi connector Part Description 1 Data Recorder Digital input connector DIGI 2 Data Recorder Auxiliary input AUX 1 3 connectors 3 Data Recor...

Страница 15: ...pe Unipolar Bipolar Auxiliary Patient Ground GND Common Reference REF SAGA 32 1x 32 unipolar multi connector SAGA 64 2x 32 unipolar multi connector 2x 2 channels 3x 3 channels Buttons Type Function ON...

Страница 16: ...inking Wireless connection lost Card Recording OFF there is no valid card recording configuration present active GREEN solid Card recording configuration loaded idle GREEN blinking Card recording acti...

Страница 17: ...Monitor interface on available GREEN blinking Monitoring interface active data exchange NOTE The remote interface is not available on all SAGA devices Type Function USB connector Primary data interfac...

Страница 18: ...to this input In case during the measurement this electrode becomes detached the amplifier will continue as Average Reference amplifier to keep the recording going This switch of the reference mode c...

Страница 19: ...y the application software The application software can use this identification data to convert the data of the sensor into the correct unit Digital input The digital input DIGI is an input for connec...

Страница 20: ...oned symbols Docking Station The device label can be found on the bottom of the Docking Station It contains general product information in light text on black background and device specific informatio...

Страница 21: ...ither powered by batteries or by mains via the Docking Station The latter only when the Data Recorder is docked on the Docking Station Insert or remove batteries Batteries can be exchanged by opening...

Страница 22: ...e docking station of the Data Recorder is approximately 10 hours two fully charged batteries The operation time on batteries is dependent on the device configuration sampling rate number of channels p...

Страница 23: ...Docking Station To undock the Data Recorder from the Docking Station push the Data Recorder in the opposite direction Depending on the device configuration a Wi Fi connection will be established If yo...

Страница 24: ...Data Recorder and accessory Connect auxiliary sensors The auxiliary inputs are marked with AUX The connector of the accessory is black The corresponding receptacles on the Data Recorder are surrounded...

Страница 25: ...rom www tmsi com or by using the USB stick that came with the device Run the TMSi SAGA Device Driver Setup x64 exe and follow the steps on screen Application Software TMSi Polybench TMSi Polybench is...

Страница 26: ...subject using one of the configurations described in the instructions for use of the SAGA Bracket The Data Recorder is to be connected to the bracket by sliding it in from the top until you hear a CLI...

Страница 27: ...form Stationary Measurement The stationary measurement setup consists of a setup where the data acquisition PC and measurement device are on a fixed place and do not move throughout the experiment The...

Страница 28: ...ally those in the same or adjacent Wi Fi channels Electrical equipment in the vicinity of the Docking Station and or Data Recorder The line of sight between Docking Station and Data Recorder Metals an...

Страница 29: ...to improve the measurement environment If backup logging is not a solution because online processing of data is a primary goal The optical fiber is connected to the fiber input on the Docking Station...

Страница 30: ...ill show after which the Card Recording icon lights up after 1 minute the device goes back to sleep mode until start recording time is reached You can always approach the configuration when you dock t...

Страница 31: ...the memory is full or when the batteries are depleted In case the measurement is interrupted because the data acquisition PC or docking station shuts down because of a major power cut or user error t...

Страница 32: ...8 0 Normal measurement data 1 Dummy data received instead of measurement data Ambulatory data Device 9 0 Not downloading ambulatory data 1 Downloading previously acquired ambulatory data Sample data...

Страница 33: ...t to always monitor the Reference Mode event as it directly influences the measurement reference Trigger inputs The digital input of the Data Recorder marked DIGI can be used to record a event trigger...

Страница 34: ...tal input Application software installed on the computer controls the SAGA measurement functions Unipolar input channels The input stage for measuring unipolar electrophysiological signals is configur...

Страница 35: ...a sensor identification feature After plugging the connector into the SAGA Data Recorder sensor identification data and where appropriate transducer conversion information and calibration data is rea...

Страница 36: ...about the availability of these configurations Electrode movement artefacts When cables pull on the electrode this is visible in the data as a DC shift because of the change in electrode skin interfa...

Страница 37: ...soft damp cloth Do not spill fluids or submerge the product in liquids Do not use sharp tools or aggressive chemicals for cleaning or disinfecting The product can be disinfected using Incidin Plus if...

Страница 38: ...ment to an environment with anti static floor and furniture and or do not unnecessarily touch product parts To prevent mains interruptions use an uninterruptible mains power supply Further guidance ca...

Страница 39: ...and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker em...

Страница 40: ...ing cables than 0 3 m Electrical fast transients burst IEC 61000 4 4 2 kV 100 kHz repetition frequency for power supply lines 1 kV for input output lines 2 kV 1 kV Degradation of performance may occur...

Страница 41: ...C 61000 4 11 0 UT 2 250 300 3 cycles 0 UT Degradation of performance may occur Interruption of AC mains may require measurement restart For further information refer to chapter 8 1 If the user of the...

Страница 42: ...Supported Sampling Rates Hz Base Rate 4096 Hz 4096 2048 1024 512 256 Base Rate 4096 Hz 4000 2000 1000 500 250 On board storage 32 GB non removable Regulatory Specifications Power source External mains...

Страница 43: ...4 GHz Range 10 m Power 16 dBm Bandwidth Maximum 2 Mb s Security WPA2 Fiber Length Up to 20 meters Bandwidth Maximum 15 Mb s Electrical Bandwidth Maximum 30 Mb s Communication Docking Station to PC USB...

Страница 44: ...available upon request Input Range Common Mode 2 V to 2 V 0 V differential Resolution 20 nV Accuracy 2 of full scale Input resistance 1 G Common Mode Rejection Ratio 100 dB typical 50 60 Hz Amplifier...

Страница 45: ...Average signal shielding and inputs are shielded with average of and signal Analogue bandwidth DC to 800 Hz at highest sampling rate 0 35 sampling rate otherwise Anti alias filter 2 1 kHz low pass Au...

Страница 46: ...64 BIP 1 BIP 2 BIP 1 2 BIP 3 BIP 4 BIP 3 4 AUX 1 1 AUX 1 2 AUX 1 3 AUX 1 AUX 2 1 AUX 2 2 AUX 2 3 AUX 2 AUX 3 1 AUX 3 2 AUX 3 3 AUX 3 PGND GND and UNI 1 32 Only available in impedance mode DIGI DIGI wi...

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