TMSi Saga 32+, Saga 64+ User Manual
92-1000-0201-0-1-0
REV 1
EN
Last update: 2019-06-13
USER MANUAL
REF
USER MANUAL SAGA
TABLE OF CONTENTS
1 SERVICE AND SUPPORT 3
About this manual 3
Contact information TMSi 3
W arr anty inf or mati on 3
Additional accessories or spare parts 4
Abbreviations 4
2 SAFETY INFORMATION 5
Explanation of mar kings 5
Limitations of use 6
Safety measures and warnings 6
Precautionary measures 7
Discl osure of r es id u al ris k 7
Information f or lays 7
Safety information f or IT-network 7
3 PRODUCT OVERVIEW 8
Product 8
Intended use 8
Product views 10
User interf ac e 15
Connections 18
Internal 3D accelerometer 19
Synchronisation Output 19
Device labels 20
Spare parts – order information 20
4 INSTRUCTIONS FOR USE 21
Power the Docking Station 21
Power the Data Recorder 21
Charge batteries 22
Docking mechanism 22
Con nect ac c essories 23
Dat a conn ecti ons 24
Sof twar e 25
SAGA Bracket 26
5 Perform a measurement 27
Perform Stationary Measurement 27
Perform Portable Measurement using W ireless connection 28
Perform Portable Measurement using Optical Fiber 29
Perform Ambulatory Measurement 29
Impedance Measurement 30
Recovery of lost data 31
Status E vents 32
6 Operational Principles 34
SAGA Device 34
Unipolar input channels 34
Reference 34
Bipolar input channels 35
Auxiliary input channels 35
Tips for obt aining optimal quality data 35
7 MAINTENANCE 37
Servicing and U pdates 37
Cleaning instructions 37
Disposal instructions 37
8 ELECTROMAGNETIC GUIDANCE 38
Degradation of perf ormanc e 38
Electromagnetic emission 39
Electromagnetic immunity 39
9 TECHNICAL SPECIFICATIONS 42
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USER MANUAL SAGA
Contact Information
Twente Medical Systems International B.V.
Zutphenstraat 57
support@tmsi.com
www.tmsi.com
1 SERVICE AND SUPPORT
About this manual
This manual is intended for the user of the SAGA 32+/64+ 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
TMSi Support can be reached via email (support@tmsi.com) or via our website:
www.tmsi.com/support. Please provide as much information as possible, including
serial numbers of the used products. This will help us to support you in the best way
possible.
7575 EJ Oldenzaal
The Netherlands
Warranty information
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.
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USER MANUAL SAGA
AUX
EEG
Electro-encephalography (Brain activity)
EMG,
HD EMG
Electromyography (Muscle activity),
REF
SN
UNI
Additional accessories or spare parts
In case you want to order additional accessories such as cables or sensors or spare
parts such as batteries, please contact
quotation.
sales@tmsi.com for consultation and a detailed
Abbreviations
Abbreviation
Auxiliary
BIP Bipolar
BOB Break-Out-Box
CF Cardiac Floating
CE Conformité Européenne
DS Docking Station
DR Data Recorder
EM, EMC Electro-magnetic, Electro-Magnetic Compatibility
High-Density Electromyography,
ECG Electrocardiography
EOG Electro-oculography
IT Information Technology
LAN Local Area Network
PC Personal Computer
Reference
RF Radio Frequency
Serial Number
TMSi Twente Medical Systems International B.V
Unipolar
USB Universal Serial Bus
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USER MANUAL SAGA
2 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 s afety information
Caution
Consult instructions for use
Type CF applied part
CE-certified, see declaration of conformity
Identification of the manuf actur er
Year of manuf acturing
Ingress protection rating
TMSi Type identification
TMSi referenc e number
TMSi serial number
Contains trans mitter module
Contains radio module for which the T echnic al Regulations Conformity Certific ation has
been granted
Special EU instructions for disposal are applicable to a product on which this symbol is
placed. The Maintenance s ection of this manual contains information on how to dispose
of this product
Wired connection status indicator; see chapter 3.3
Wi-Fi connection status indic ator; s ee chapter 3.3
On-board memory status indic ator; s ee chapter 3.3
Signal Mode status indicator; see chapter 3.3
Battery status indic ator; all status indicators are explained in chapter 3.3
Stand-by symbol
Power status indic ator; all status indicators are explained in chapter 3.3
Remote Interface status indicator; all status indic ators are explained in chapter 3.3
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USER MANUAL SAGA
Limitations of use
There are no known contra-indications to the use of the SAGA product. For further
information refer to chapters 2.3, 2.4 and 3.2.
• This product is not intended for use in a life supporting system.
• This product is not defibrillator-proof.
• This product is not intended for use in oxygen rich envir onments or in combination with
anaes thet ic g asses.
• This product is not compatible with HF surgic al equipment.
• This product is not intended for us e on altitudes higher than 3000 m above s ea level.
• This product is not to be used in the presence of Magnetic Resonanc e Imaging (MRI)
devic es .
Safety measures and warnings
Connect the mains power adapter onl y to a supply mains with protective earth to a void the risk of
electric shock.
Only use the SAGA prod uct with the supplied mains power adapter or a replacement explicitl y
approved by TMSi to avoid the risk of electric shock.
Only use accessories explicitly approved by TMSi to avoid the risk of electric shock.
Do not connect equipment that is not IEC 60950 compliant to SAGA to a void the risk of electric
shock.
Do not touch pins of removed batteries or of disengaged connector plugs or sockets to avoid the
risk of electric shock.
Do not use 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 equipm ent on the same subject to
avoid damage to the product.
Do not use or store n ear sources with particle radiation or elevated levels of electrical, m agnetic or
electro-magnetic fields to avoid dam age to the product.
Only connect T MSi approved accessories and equipment to SAGA to avoid dam age to it and
reciprocal interference.
Do not use SAGA togeth er with magnetic resonance imaging equipment on the same subject to
avoid reciprocal interference.
Do not tamper with an y part of SAGA. No modifications are allowed to maintain safety.
Use of SAGA adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, SAGA and the other equipment should be
observed to verif y that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of SAGA could result in increased electromagnetic emissions or decreased
electromagnetic immunity of SAGA and result in i mproper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the SAGA
including i ts cables. Otherwise SAGA performance degradation could result.
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USER MANUAL SAGA
Precautionary measures
Whenever data availability is important make sure the Data Recorder contains at least one sufficiently
charged battery as a bac kup for mains power failure.
Make sure sufficiently charged batteries are inserted before ambulatory use of SAGA. If necessary,
provide for extra fully charged batteries for swapping.
Remove batteries from SAGA if it is not likely to be used for some time.
To prolong batter y life, store them preferably at 40 % charged state and at a temperature in the range
(-20 to 20) °C.
To avoid signal disturbance, keep SAGA away from sources of strong electric, magnetic and
electromagnetic radiation.
To avoid loss of data use wired communication for data transport and control.
Route cables for a comfortable wear and freedom of movement for the subject; properly secure any
excess cable, for example with some tape or Velcro.
Prevent prolonged physical contact with metal connector parts as they may contain nickel. If
necessary, tape them off using for example a band aid.
If any part of SAGA appears obviously malfunctioning or damaged, refrain from further using it and
contact the manufacturer for repair and check of the device.
SAGA is not defibrillation-proof equipment. T o 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 m ains power adapter from the SAGA
Docking Station or disconnect the supply cable of the mains power adapter on at least one end.
Make sure that at least one of these options is easily accessible.
Disclosure of residual risk
The intended and foreseeable use of the SAGA product bears an acceptable risk.
No specific residual risks need to be disclosed.
Information for lays
The user of the product shall instruct lay operators of the product on the following
topics:
• Contr a-indications on the use and usage environments.
• Which indicators, if any, must be monitored, how often, and how to react on specific status
indications.
• When to press the Event marker button.
• Specific ally: how batteries must be exchanged and recharged, if their running out is expected.
Safety information for IT-network
Connection of SAGA t o an IT-network that includes other equipment could result in previously
unidentified risks.
The customer should identify, analyse and control these risks.
Subsequent changes to the IT-network could introduce new risk and require additional analysis.
Such changes to the IT-network include: Changes to configuration, connecting or disconnecting items,
update or upgrade of connected equipment.
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USER MANUAL SAGA
3 PRODUCT OVERVIEW
Product
The product consists of the following components:
• SAGA 32+/64+: (Electro-)physiological amplifier consisting of:
o Data Recorder.
o Docking Station.
• Accompanying documentation: User Manual and certificates.
• TMSi Device Driver.
The product is delivered with the following items to increase the ease of use: a
suitcase, battery charger, SAGA bracket and TMSi Polybench including the Quick
Recording Application for SAGA.
The product is intended to be used with approved electrodes and sensors which can
be found on the TMSi website
of those electrodes and sensors.
Intended use
www.tmsi.com. Please refer to the instructions for use
Subject population
The product is designed for acquisition of (electro)-physiological signals (e.g. EEG,
EMG or ECG). The product is intended to be used by research professionals in a
laboratory setup, or to be set-up in such an environment after which the subject must
be instructed how to handle/operate the device. After that instruction the subject can
be sent out for an ambulatory measurement. Upon return, the data is retrieved from
the on-board memory of 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 operating principle
The product amplifies and stores signal data picked up via electrode leads or sensors
that are connected to a single subject; no data interpretation is performed. Intended
use of this product does not require expected positions of the user or subject. No
essential consumables are required for the intended use of this product, however
commercially available disposable electrode patches and/or contact gel can be used
for contact between electrode and subject skin.
The Data Recorder can be worn on the body during portable and ambulatory
measurement setups in which case its enclosure outside is an accessible part. The
Data Recorder’s main function is to capture and digitize the (electro-) physiological
data. The Docking Station’s main function is to receive the data from the Data
Recorder and transfer it to the PC and to (re)charge the battery. The Docking Station
is not intended to contact the subject or carried by the subject.
Applied parts
The product has a single Type CF applied part with multiple functions. It consists of
the front-side receptacles (pins and shield) on the SAGA Data Recorder enclosure
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USER MANUAL SAGA
marked with an applied part symbol, because these connect galvanically to proximal
and distal ends of subject accessories (simple leads as well as transducers).
User population
The product is intended to be used by, or under supervision of, a physician or
research professional. The user must have knowledge of current good practice in
physiological measurement applications. In ambulatory measurement setups the
subject can be a user as well, after being instructed how to use the system. Refer to
chapter 2.6 for the instructions for lays.
User interface
The different user interfaces of the product are:
• The user interface of the Data Recorder.
• The user interface of the Docking Station.
• The user interface of the control software running on the computer or
remote interface.
The user interface of the Data Recorder consists of an Event marker button,
Recording button, an On/Off button and status indicators. The user interface of the
Docking Station consists of status indicators. All status indicators are explained in
chapter 3.3.
The product can be controlled via the user interface of the application software
running on a computer, or via the remote interface. The application software on the
PC is used for storage and visualization 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 limits as specified in
chapter 9, excluding environments with restricted access due to ionizing radiation
and/or strong magnetic fields. The product is not intended for use in a life supporting
system. The product is designed for continuous operation and is reusable without
requiring any level of sterility or reprocessing. No special handling or pre-treatment
is required other than connecting subject accessories between subject and SAGA.
Only use the product with the supplied parts and accessories. In case other parts or
accessories are required, contact TMSi Support (
support@tmsi.com) for information.
Expected service life
The expected service life of the device is 7 years. If the product is intended to be
used after its expected service life, contact TMSi to have the product inspected
before continued use. For the expected service life and shelf life of the batteries,
refer to the instructions for use of the batteries. For the expected service life of the
other accessories delivered with the system, refer to the instructions for use of the
accessories.
The product requires no regular servicing or maintenance and may not be modified,
but it may be cleaned as described in
be performed by the manufacturer.
chapter 7. Repairs and modifications can only
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USER MANUAL SAGA
Intended use
The product is intended for acquisition of (electro)-physiological signals (e.g. EEG,
EMG or ECG) from humans by research professionals as described above and in
setups and environments as described above.
Essential performance
Under normal conditions the product ensures:
• All data of a measurement session becomes available.
This means that the product makes all data acquired through the product
promptly available as digital data, 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 signal data. The
product provides means to repair such losses (refer to
provides alternative means of data communication to reduce the likelihood
of data loss. It is up to the user to decide the best means of obtaining signal
data from the product depending on the specific application.
For information regarding performance under abnormal conditions refer to
chapter 8.Product views
chapter 5.6) and
Top View
# Description
1. Event mar k er button
2. Status indicator window
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# Description
1. Arrow indicating direction for docking Data Recorder
2. Docking c onnec tor (pins)
3. D ocking rails to guide and secure Data Recorder to the Docking Station
4. Fiber connector (behind c over)
5. Status indicator window
Front View
# Marking Description
1. AUX 1-3 Auxiliary input conn ectors
2. BI P 1,2 – 3,4 Bipolar input connectors
3. GND Patient Ground connector
4. REF Common Referenc e input conn ec tor
UNI 1-32
5.
/ UNI 33-64
6 Docking rails to guide and secure Data Recorder to the D ocking Station
Multi-connector (UN I 1-32) and/or (33-64)
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USER MANUAL SAGA
Bottom View
Docking Station
# Description
1. Gutters for docking on the SAGA Bracket
2. Devic e label
3. Dock security ribbon for SAGA Bracket
Data Recorder
# Description
1. Docking con nect or (c ontact points)
2. Gutters for docking on the Docking Station or Bracket
3. Device label
4. Dock security ribbon for SAGA Bracket
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USER MANUAL SAGA
Back view
# Part Description
1. Data Recorder Event marker button
2. Data Recorder Release buttons for battery compartments
3. Docking Station Trigger connec tor (behind 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 P ower status indic ator
9. Docking Station Power c onnector
10. Docking Station Fiber connector (behind c over)
11. Data Recorder ON/OFF button
12. Data Recorder Recording button
13. Data Recorder Fiber connector (behind cover)
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USER MANUAL SAGA
Side views
# Part Description
1. Data Recorder SYNC OUT c onnec tor
2. Data Recorder Fiber cover
3. Data Recorder Recording button
4. Data Recorder ON/OFF button
5. Docking Station Fiber cover
6. Data Recorder UNI 1-32 multi-connector
# Part Description
1. Data Recorder Digital input c onnector (DIGI)
2. Data Recorder Auxiliary input (AUX 1-3) c onnector s
3. Data Recorder Bipolar input (BI P 1-2 and BIP 3-4) conn ectors
4. Docking Station Trigger connector (behind cover)
5. Data Recorder Compartment f or battery 2
6. Data Recorder Compartment f or battery 1
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USER MANUAL SAGA
User interface
Data Recorder
Connections
Type Function
Docking connector
Fiber connector
Connects the Data Rec order to the Docking Station for power
supply and data i nt erface
Connects the Data Recorder to the Docking Station for optical
data transmission
Subject connections
Type Unipolar Bipolar Auxiliary
SAGA 32+ 1x 32 unipolar
Patient Ground (GND),
Com mon R ef er enc e (REF)
(multi-conn ector)
SAGA 64+ 2x 32 unipolar
(multi-conn ector)
2x 2 channels
3x 3
channels
Buttons
Type Function
ON/OFF Switches the devic e on/off if device is not s ampling
Event marker
Recording
Can be pressed by the subject or operator to log a certain time
point or create an event on the sync out port
Starts and stops recording on internal memory if c onfigur ation
allows a manual start/stop of the ambulatory recording
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