user manual saga - tmsi

REF 92-1000-0101-0-1-0

0344 REV 1 EN Last update: 2019-06-07

USER MANUAL

USER MANUAL SAGA

of 48

TABLE OF CONTENTS 1 SERVICE AND SUPPORT 3

About this manual 3 Contact information TMSi 3 Warranty information 3 Additional accessories or spare parts 4 Abbreviations 4

2 SAFETY INFORMATION 5 Explanation of markings 5 Limitations of use 6 Safety measures and warnings 6 Precautionary measures 7 Disclosure of residual risk 7 Information for lays 7 Safety information for IT-network 7

3 PRODUCT OVERVIEW 8 Product 8 Intended use 8 Product views 11 User interface 16 Patient connections 19 Internal 3D accelerometer 20 Synchronisation Output 20 Device labels 21 Spare parts – order information 21

4 INSTRUCTIONS FOR USE 22 Power the Docking Station 22 Power the Data Recorder 22 Charge batteries 23 Docking mechanism 23 Connect accessories 24 Data connections 25 Software 26 SAGA Bracket 27

5 PERFORM A MEASUREMENT 28 Perform Stationary Measurement 28 Perform Portable Measurement using Wireless connection 29 Perform Portable Measurement using Optical Fiber 30 Perform Ambulatory Measurement 30 Impedance Measurement 31 Recovery of lost data 32 Status Events 33

6 Operational Principles 35 SAGA Device 35 Unipolar input channels 35 Reference 35 Bipolar input channels 36 Auxiliary input channels 36 Tips for obtaining optimal quality data 36

7 MAINTENANCE 38 Servicing and Updates 38 Cleaning instructions 38 Disposal instructions 38

8 ELECTROMAGNETIC GUIDANCE 39 Degradation of performance 39 Electromagnetic emission 40 Electromagnetic immunity 40

9 TECHNICAL SPECIFICATIONS 43

USER MANUAL SAGA

of 48

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 ([email protected]) 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.

Contact Information Twente Medical Systems International B.V. Zutphenstraat 57 7575 EJ Oldenzaal The Netherlands

[email protected] www.tmsi.com

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.

mailto:[email protected]

http://www.tmsi.com/support


http://www.tmsi.com/

USER MANUAL SAGA

of 48

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 [email protected] for consultation and a detailed quotation.

Abbreviations

Abbreviation

AUX Auxiliary

BIP Bipolar

BOB Break-Out-Box

CF Cardiac Floating

CE Conformité Européenne

DS Docking Station

DR Data Recorder

EEG Electro-encephalography (Brain activity)

EM, EMC Electro-magnetic, Electro-Magnetic Compatibility EMG, HD EMG

Electromyography (Muscle activity), High-Density Electromyography,

ECG Electrocardiography

EOG Electro-oculography

IT Information Technology

LAN Local Area Network

PC Personal Computer

REF Reference

RF Radio Frequency

SN Serial Number

TMSi Twente Medical Systems International B.V

UNI Unipolar

USB Universal Serial Bus


USER MANUAL SAGA

of 48

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 safety information

Caution

Consult instructions for use

Type CF applied part

CE-certified (93/42/EC Annex XII), 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 3.4

Wi-Fi connection status indicator; see chapter 3.4

On-board memory status indicator; see chapter 3.4

Signal Mode status indicator; see chapter 3.4

Battery status indicator; all status indicators are explained in chapter 3.4

Stand-by symbol

Power status indicator; all status indicators are explained in chapter 3.4

Remote Interface status indicator; all status indicators are explained in chapter 3.4

USER MANUAL SAGA

of 48

Limitations of use There are no known patient related 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 environments or in combination with

anaesthetic gasses. • This product is not compatible with HF surgical equipment. • This product is not intended for use on altitudes higher than 3000 m above sea level. • This product is not to be used in the presence of Magnetic Resonance Imaging (MRI)

devices.

Safety measures and warnings

Connect the mains power adapter only to a supply mains with protective earth to avoid the risk of electric shock.

Only use the SAGA product with the supplied mains power adapter or a replacement explicitly approved by TMSi to avoid the risk of electric shock.

Only use patient 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 avoid 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 equipment on the same patient to avoid damage to the product.

Do not use or store near sources with particle radiation or elevated levels of electrical, magnetic or electro-magnetic fields to avoid damage to the product.

Only connect TMSi approved accessories and equipment to SAGA to avoid damage to it and reciprocal interference.

Do not use SAGA together with magnetic resonance imaging equipment on the same patient to avoid reciprocal interference.

Do not tamper with any 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 verify 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 improper 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 its cables. Otherwise SAGA performance degradation could result.

USER MANUAL SAGA

of 48

Precautionary measures

Whenever data availability is important make sure the Data Recorder contains at least one sufficiently charged battery as a backup 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 battery 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 patient cables for a comfortable wear and freedom of movement for the patient; 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. To avoid damage to it, disconnect it fully from the patient before applying defibrillation shocks.

In order to isolate SAGA from the supply mains, disconnect the mains 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:

• Contra-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. • Specifically: how batteries must be exchanged and recharged, if their running out is expected.

Safety information for IT-network

Connection of SAGA to 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.

USER MANUAL SAGA

of 48

3 PRODUCT OVERVIEW

Product The medical device 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 medical device is part of a medical system that also includes the batteries, a mains power adapter and cables for data connections between the product parts and a PC.

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. These items are not part of the medical system.

The product is intended to be used with approved electrodes and sensors which can be found on the TMSi website www.tmsi.com. Please refer to the instructions for use of those electrodes and sensors.

Intended use Medical indication and patient population The product is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/research professionals in a laboratory setup, or to be set-up in such an environment after which the subject/patient must be instructed how to handle/operate the device. After that instruction the patient 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 patient population where the product can be used on. The product can be used on healthy subjects or patients of various kinds regardless of age, gender or other criteria.

Patient interface and operating principle The product amplifies and stores signal data picked up via electrode leads or sensors that are connected to a single patient or subject; no data interpretation is performed. Intended use of this product does not require expected positions of the user or patient. 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 patient 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


USER MANUAL SAGA

of 48

Recorder and transfer it to the PC and to (re)charge the battery. The Docking Station is not intended to contact the patient or carried by the patient.

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 marked with an applied part symbol, because these connect galvanically to proximal and distal ends of patient 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 in science and clinical applications. In ambulatory measurement setups the patient or 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 3.4.

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 clinical (research laboratory or medical office) 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 patient accessories between subject/patient and SAGA.

Only use the product with the supplied parts and accessories. In case other parts or accessories are required, contact TMSi Support ([email protected]) 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,


USER MANUAL SAGA

of 48

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 chapter 7. Repairs and modifications can only be performed by the manufacturer.

Intended use The product is intended for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG) from humans, regardless of any specific medical indication, by medical/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 chapter 5.6) and 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.

USER MANUAL SAGA

of 48

Product views Top View

# Description

1. Event marker button

2. Status indicator window

# Description

1. Arrow indicating direction for docking Data Recorder

2. Docking connector (pins)

3. Docking rails to guide and secure Data Recorder to the Docking Station

USER MANUAL SAGA

of 48

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 connector

4. REF Common Reference input connector

5. UNI 1-32 / UNI 33-64 Multi-connector (UNI 1-32) and/or (33-64)

6 Docking rails to guide and secure Data Recorder to the Docking Station

USER MANUAL SAGA

of 48

Bottom View

Docking Station

# Description

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 Station or Bracket

3. Device label

4. Dock security ribbon for SAGA Bracket

USER MANUAL SAGA

of 48

Back view

# Part Description

1. Data Recorder Event marker button

2. Data Recorder Release buttons for battery compartments

3. Docking Station Trigger connector (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 Power status indicator

9. Docking Station Power connector

10. Docking Station Fiber connector (behind cover)

11. Data Recorder ON/OFF button

12. Data Recorder Recording button

13. Data Recorder Fiber connector (behind cover)

USER MANUAL SAGA

of 48

Side views

# Part Description

1. Data Recorder SYNC OUT connector

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 connector (DIGI)

2. Data Recorder Auxiliary input (AUX 1-3) connectors

3. Data Recorder Bipolar input (BIP 1-2 and BIP 3-4) connectors

4. Docking Station Trigger connector (behind cover)

5. Data Recorder Compartment for battery 2

6. Data Recorder Compartment for battery 1

USER MANUAL SAGA

of 48

User interface Data Recorder

Connections

Type Function

Docking connector Connects the Data Recorder to the Docking Station for power supply and data interface

Fiber connector Connects the Data Recorder to the Docking Station for optical data transmission

Patient connections

Type 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/OFF Switches the device on/off if device is not sampling

Event marker Can be pressed by the patient or operator to log a certain time point or create an event on the sync out port

Recording Starts and stops recording on internal memory if configuration allows a manual start/stop of the ambulatory recording

USER MANUAL SAGA

of 48

Status Indicators

Indicator Function and states

Reference Mode

• OFF: Average Reference mode

• GREEN (solid): Common Reference mode

• ORANGE (solid): Common Reference not available

• ORANGE (blinking): Common Reference disconnected after start recording, device switched to Average Reference mode.

Wired

Connection

• OFF: not using fiber connection

• GREEN (solid): Connection with Docking Station via fiber

•

Wireless

Connection

• OFF: Wi-Fi disabled / not looking for Docking Station

• GREEN (solid): Wireless connection, no data transmission

• BLUE (blinking): No Wi-Fi Link, looking for Docking Station

• ORANGE (blinking): 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 active

• BLUE (solid): Card in Configuration / Read-out mode; idle

• BLUE (blinking): Writing Configuration / Downloading data

• ORANGE (solid): Card error (full, no repair mode possible)

• ORANGE (blinking): Card almost full

Signal Mode

• OFF: Data Recorder is off

• GREEN (solid): Device is in Signal mode

• GREEN (blinking): Signal data transmission active

• BLUE (solid): Device is in Impedance mode

• BLUE (blinking): Impedance data transmission active

• GREEN/BLUE (blinking): Device is booting

Battery State

• OFF: Battery is not charging

• GREEN (solid): Battery fully charged

• BLUE (solid): Battery charging

• ORANGE (solid): Battery error

• ORANGE (blinking): Battery low

USER MANUAL SAGA

of 48

Docking Station

Connections

Status indicators

Indicator Function and state

Power

• OFF: Docking Station is off or booting

• GREEN (solid): Docking Station is ready

Wireless

Connection

• OFF: there is no wireless connection

• GREEN (solid): Wi-Fi connection, no data transmission

• GREEN (blinking): Active data transmission over Wi-Fi connection

• BLUE (blinking): looking for Data Recorder

Remote Interface*

• OFF: monitoring interface not available (locked)

• GREEN (solid): 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 interface to PC

Ethernet connector

Secondary data interface to PC

Trigger connector

16-bit trigger input to acquire signals from external equipment.

*NOTE: The 16-bit trigger interface is not available on all SAGA devices

Fiber connector Connector for an optical fiber for data interface with a Data Recorder

Power connector Supply power from Mains adapter to Docking Station

Docking connector

Connector to dock Data Recorder to Docking Station for power supply and data interface

USER MANUAL SAGA

of 48

Lights The lights on the backside of the Docking Station can have the following states.

Patient connections Patient Ground input The Patient Ground must be connected to keep the amplifier in range. The Patient Ground connection can be made using a separate lead connected to the GND input. For some accessories, the Patient Ground connection is also available in the UNI 1-32 multi-connector. Consult the instructions for use of your accessories to check this. If this is the case, it is not required to connect the Patient Ground lead to the GND input of the amplifier.

Common Reference input The Common Reference input (REF) is optional to use. This input is also available in the UNI 1-32 multi-connector. Electrode placement is up to the user and depends on the type of measurement. If Common Reference mode is configured, all unipolar inputs are referred 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 can be disabled in software. The switch from reference mode will be also logged as an event trigger in the digital channel.

Unipolar multi-connector inputs The unipolar multi-connector includes 32 unipolar channels to connect for example an EEG head cap, HDEMG cable, SAGA Break-Out-Box or other accessories. The SAGA Data Recorder has one or two unipolar multi-connectors, depending on the configuration.

Lights Function

Power • OFF: Docking Station is off

• GREEN (solid): Docking Station is switched on

Ethernet

• OFF: there is no ethernet connection present

• GREEN (solid): ethernet connection present; idle

• GREEN (blinking): ethernet connection active

Ethernet (Connector

lights)

• OFF: there is no cable connected

• GREEN: Link detected

• ORANGE (blinking): Data transmission active

USB

• OFF: there is no USB connection present

• GREEN (solid): USB connection present; idle

• GREEN (blinking): USB connection active

USER MANUAL SAGA

of 48

Bipolar inputs The bipolar input is used for electrophysiological measurements such as EMG, ECG and EOG. Bipolar inputs are characterized by a pair of electrodes for a + and a – input signal, the difference of which is recorded. The device supports up to 4 bipolar channels, accessible via two bipolar input connectors with two bipolar channels each. An electrode lead may have one pair of electrodes or two pairs of electrodes.

Each bipolar electrode lead plug can contain an identification that can be read out by the application software.

Auxiliary inputs The auxiliary inputs are to be used for connecting sensors, particularly those that contain transducers, to SAGA. The device supports 9 auxiliary channels, which are divided over three input connectors. Sensors that have multiple functions and/or transducers, such as the 3D accelerometer will use the three sub-channels of an AUX input.

An AUX sensor may contain an identification feature that can be read out by 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 connecting an event trigger cable or digital serial sensors, for example a NONIN digital saturation sensor.

Internal 3D accelerometer The Data Recorder contains an internal 3D accelerometer that can track the acceleration in three dimensions and the orientation of the Data Recorder.

The figure shows how the orientation of the 3D accelerometer inside the device is. When the device is worn on the body, it is designed such that the z-direction points downwards.

Synchronisation Output The synchronization output can be used to synchronize external devices, application software or other devices of the SAGA family. The synchronization output is available on the Data Recorder (SYNC OUT).

By default, the SYNC OUT is configured in ‘Event Marker’ mode, meaning that a synchronization pulse is sent out upon pressing the Event marker button. One can configure the SYNC OUT to be a clocked pulse via the application software. The SYNC OUT port requires a special cable which can be ordered via [email protected].


USER MANUAL SAGA

of 48

Device labels Data Recorder

The device label can be found on the bottom of the Data Recorder. It contains general product information, in light text on black background and device specific information, black text on light background, such as Serial Number (next to SN), Reference number (next to REF) and device type (next to TYPE). Please note that the depicted device specific information is an impression of the actual

information that is found on the label. The Type (next to TYPE) describes the exact version of Data Recorder, such as the number of channels (32+ or 64+ and other possible variation (different gain or otherwise).

The device label also contains general product information. Please consult 2.1 for information about the meaning of all mentioned 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 information, in black text on light background,such as Serial Number (next to SN) and Reference number (next to REF). Please note that the depicted device specific information is an impression of the actual information that is found on the label.

The device label also contains general product information. Please consult 2.1 for information about the meaning of all mentioned symbols.

Spare parts – order information Spare parts that can be ordered separately:

• Suitcase. • Replacement batteries. • External battery chargers for SAGA batteries. • Mains Power supply. • Optical fibers in various lengths up to 20 metres. • Trigger cable. • Synchronisation out cable. • SAGA Bracket and straps. • Patient accessories such as Break-Out-Boxes, EEG caps, electrode leads

and AUX Sensors. See www.tmsi.com for more details.


USER MANUAL SAGA

of 48

4 INSTRUCTIONS FOR USE

Power the Docking Station Plug the mains power plug into a well-earthed mains socket and connect the power adapter connector to the Docking Station. Make sure you use the correct orientation. When you insert the connector, you will hear a ‘click’. Once connected to mains, the Docking Station automatically powers up, indicated by the power light on the back and after a start-up period, the power indicator in the status indicator window signals that the Docking Station is fully operational.

The Docking Station can be powered down by unplugging the mains power connector.

Power the Data Recorder The Data Recorder is either 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 the battery compartments:

1. Press the orange release button (see 1 in figure below). 2. The compartment door will open enough to grab it with a finger; now you

can pull it open (see 2 in figure below). 3. Slide in the battery, with battery contacts first and oriented to the left.

For further instructions, refer to the Quick Guide in the inlet of the suitcase. 4. Close the battery compartment door, until you hear and feel that it locks.

Briefly press the On/Off button to power on the Data Recorder. When the device is not acquiring data, the ON/OFF button also powers down the Data Recorder. During a measurement, the Data Recorder will not power down by means of the ON/OFF button.

USER MANUAL SAGA

of 48

Battery change during measurement Batteries can be exchanged during measurement. Please note that to continue the recording without interruption, there should always be at least one -sufficiently charged- battery inserted while exchanging batteries.

Battery low indication When the battery charge is lower than a certain level, the battery indicator in the status indicator window starts to blink orange. This indicates that it is time to swap the battery.

The batteries of the Data Recorder are charged via the Docking Station, when the Data Recorder is docked onto it or by using the external Battery Charger (see accessories and add-ons).

Battery discharge Batteries are discharged on an ‘equal level’ base. This means that if you insert two batteries, they are being discharged at the same speed. In case there are two batteries with unequal charge, it will be discharged until they reach the same level. A battery low indication will therefore always apply to both batteries.

Operation time The operation time when not on the 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, power consumption of sensors etc.). The operation time does not include scenarios where batteries are exchanged, or recharged, during measurement (see above).

Charge batteries Batteries can be (re-)charged via the Docking Station, or using an external battery charger.

Via Docking Station The batteries of the Data Recorder are automatically charged whenever it is docked on the Docking Station.

External battery charger Remove the battery from the Data Recorder and use the external battery charger as described in the Instructions for Use of the external charger.

Storage and empty batteries To prevent draining the batteries, it is recommended to remove the batteries from the device when you store it for a period longer than a week. If you do not remove the batteries from the device, make sure a sufficient charge remains in the device as it may be drained completely.

Docking mechanism Establish an electrical connection between Data Recorder and Docking Station by sliding the Data Recorder in the Docking Station. Align the docking rail of the Docking

USER MANUAL SAGA

of 48

Station and the gutters on the bottom of the Data Recorder. See illustrations below. The wired connection indicator in the status indicator windows will light up green when the connection is made correctly.

1. The arrows on the Docking Station indicate the direction for docking the Data

Recorder and the alignment point for the docking rail of the Docking Station. 2. Make sure the Data Recorder is aligned properly and slide it gently onto the

Docking Station. 3. Push forward until the Docking Station and Data Recorder are perfectly

aligned on top of each other and you cannot push any further.

You may dock the Data Recorder on the Docking Station while recording. This may cause artefacts in the signals. In order to minimize artefacts, gently slide the Data Recorder on the 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 you did not configure the device for wireless operation, the connection between Data Recorder and Docking Station is now interrupted.

Connect accessories The connectors for patient accessories, except the Patient Ground and Common Reference described in this section are all provided with a ‘Push-Pull’ mechanism, to prevent them from getting detached inadvertently. This means that each connector plug is provided with a sleeve part that slides a bit along the axis of the plug to operate a retention mechanism. To make a connection, observe the alignment symbols and gently push the plug into the receptacle of the SAGA device. To disconnect, take hold of the plug at its moving sleeve, the part closest to the socket, and gently pull the plug out. Do NOT pull at the accessory wire or at the wire end of the plug.

USER MANUAL SAGA

of 48

Connect accessory to multi-connector The multi-connector inputs are labelled with ‘UNI’. Connect the connector of the accessory to the correct input. Both the connector and the input on the Data Recorder have a dot on them. Align the red marking on the multi-connector with the orange dot adjacent to the multi-connector input of the Data Recorder. The UNI 1-32 and UNI 33-64 connector are to be placed in each other’s opposite, e.g. the part where the cables exit the connector face towards each other.

Connect bipolar electrodes The bipolar inputs are marked with BIP. The connector of the accessory is white. The corresponding receptacles on the Data Recorder are surrounded by a white ring. Align the orange dot on the enclosure with the arrow on the bipolar connector. Do not use excessive force to insert the connector. This may damage both 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 by a black ring. Align the arrow with the orange dot above the input on the Data Recorder. Do not use excessive force to insert the connector. This may damage both Data Recorder and accessory.

Connect digital sensor The input for a digital sensor is marked with ‘DIGI’. The connector of the accessory is nickel. Align the arrow with the orange dot above the input on the Data Recorder. Do not use excessive force to insert the connector. This may damage both Data Recorder and accessory.

Data connections Refer to chapter 9 for used protocols, requirements and settings as applicable.

NOTE

In case of connecting SAGA to a LAN network via the ethernet interface, it is recommended to use a secure, non-open network connection.

# Description

1. SAGA (Docking Station)

2. Data acquisition PC

3. Data connection of preference: USB or Ethernet

4. Control from PC to SAGA

5. Data from SAGA to PC

USER MANUAL SAGA

of 48

The Docking Station of the SAGA system (1) can be connected to a PC (2) via a USB cable and via an Ethernet cable (3). Both connections are used for control of the device (4) and data transfer to the PC where it can be stored for further processing (5). It is also used for sending commands from the application software to the SAGA system to control the device (start/stop, configuration updates etc.).

Software System requirements

Computer requirements

Supported Operating systems

• Windows 10 (64 bit)

• Windows 7 SP1 (64 bit)

Available ports • USB port (2.0 or higher)

• (Optional) Ethernet port (>100 Mbit)

Hard drive • 200 GB available (for storage of measurement data)

Driver installation The latest version of the driver can be downloaded from 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 software that is commercially available through TMSi. TMSi Polybench can be used for experimenting with different configurations and customer specific applications. TMSi Polybench is the framework on which the SAGA Quick Recording Application was built. TMSi Polybench is software that is intended for research purposes only and may not be used for diagnosis or treatment.

The Quick Recording Application (QRA) can be used to do recordings with the SAGA system. The QRA can also be used to configure the SAGA Data Recorder.

Please note that neither the TMSi Polybench nor the Quick Recording Application (‘QRA’) is part of the medical device. These applications are not intended to be used for diagnosis or treatment. The QRA can be used to control the device and to visualize the signals.

TMSi Interface for MATLAB TMSi has developed an interface to MATLAB (www.mathworks.com). The interface can be downloaded free of charge on the TMSi website. TMSi does not sell or distribute MathWorks products, nor supports them.


http://www.mathworks.com/

USER MANUAL SAGA

of 48

SAGA Bracket Secure Data Recorder to the patient It is recommended to use the SAGA Bracket to secure the Data Recorder to the patient in setups where the device is carried by the patient or taken home with the patient.

Secure the bracket to the patient 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 ‘CLICK’.

The SAGA Bracket optimizes the carrying comfort by the patient.

Wall Mount The SAGA Bracket can also be used to mount the device to a wall, IV pole or medical DIN rail. Please consult the suggested mounting methods in the instructions for use of the bracket for more details.

USER MANUAL SAGA

of 48

5 PERFORM A MEASUREMENT SAGA supports a variety of usage scenarios:

• Streaming data in stationary use (5.1). • Streaming data in portable setting via wireless connection (5.2). • Streaming data in portable setting via optical fiber (5.3). • Ambulatory recording without data streaming (5.4).

Perform 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 Data Recorder is docked in the Docking Station.

Advantages • Maximum data throughput and signal bandwidth at all channels

(4000/4096 Hz). • Most reliable data transmission. • Virtually unlimited recording time. • System can be mounted to a trolley, medical DIN rail.

Disadvantages • Limited freedom of movement for patient.

USER MANUAL SAGA

of 48

Perform Portable Measurement using Wireless connection In the portable measurement setup, the Data Recorder is undocked from the Docking Station and the Wi-Fi Link is used for data transmission. This setup is optimal for usage scenarios where freedom of movement is an important requirement.

The data from the Data Recorder is sent through Wi-Fi to the Docking Station. Please note that successful wireless data transmission can never be guaranteed, even when the amount of data (few channels, low sampling rate) is low. If the Docking Station does not receive a data package, this data is not transmitted again, but considered to be lost at that moment. Lost data can be recovered using the backup logging feature on the on-board memory (see below).

Factors that influence wireless transmission are:

• Other wireless networks (or RF devices such as smartphones, tablets), especially 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 and human beings tend to absorb or reflect a lot of wireless signals.

It is recommended to scan the environment for possible wireless interference sources.

Pairing of Docking Station and Data Recorder The Docking Station acts as an access point for the Data Recorder. Once docked, the Data Recorder and Docking Station will exchange pairing codes automatically. When you configure the device for wireless use, the connection between Docking Station and Data Recorder is made.

Data backup logging During a measurement via a wireless data connection, the Data Recorder will log the measurement data on the on-board memory card as backup. Lost data can be

USER MANUAL SAGA

of 48

retrieved after the measurement has been finished. Refer to chapter 5.6 for more detailed instructions on recovery of lost data.

This feature can be disabled in software. Obviously, this will result in a situation where lost data cannot be recovered.

Bandwidth management A consequence of using wireless data transmission is a limited data transfer bandwidth. This may require a reduction in the sampling frequency and/or number of channels that can be recorded. This can be configured to your needs via the

application software.

Perform Portable Measurement using Optical Fiber The optical fiber can be useful in the following setups:

• If the Wi-Fi link cannot reach the bandwidth that is needed for the measurement and freedom of movement is an important requirement.

• If the Wi-Fi is not reliable due to interference sources and no other measures can be taken 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 and Data Recorder after removing the protective covers on Data Recorder and Docking station. The rubber covers are marked with the text: ‘fiber’.

Please note the orientation of the fiber connector. The notch must be pointed downwards. Do not force the fiber connector into the slot.

Perform Ambulatory Measurement In an ambulatory measurement setup, the Data Recorder is used as a data logger without the function of data streaming. Typically, this is a user scenario where a

USER MANUAL SAGA

of 48

patient is sent home with the Data Recorder for ambulatory monitoring. The data is logged on the on-board memory and can be downloaded from the on-board memory afterwards.

Measurement Configuration Configure the ambulatory recording to your needs in the application software. It is not possible to stream data during ambulatory measurements; all measurement data is logged on the on-board memory of the Data Recorder.

Start/stop using the Recording button The button on the Data Recorder marked with an SD Card icon can be used to start and stop an ambulatory recording. Press and hold the button for 2 seconds to start recording. Press and hold for 2 seconds again to stop the recording.

Start or Stop recording time In some user scenarios, the recording should start and/or stop at a specific moment in time. The start and stop recording times can be configured in the application software. The time of the Data Recorder is synchronized to time of the PC when the Data Recorder connects to a Docking Station that is connected to a PC.

After saving the configuration on the device, the Card Recording icon will light up green. You may now switch off the device. The device will start automatically when the start recording time is reached. When you switch on the Data Recorder before the start recording time is reached, the start-up sequence will 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 the Data Recorder on the Docking Station.

Downloading measurement data from Data Recorder When the ambulatory recording is finished, the data can be retrieved via the application software. The recordings are downloaded and stored on the PC for further analysis. Depending on the configuration and length of the ambulatory recording, downloading all data may take a while (several minutes to hours). In the meantime, the system cannot be used for other measurements.

Impedance Measurement The Data Recorder can be switched to impedance mode. In impedance mode the user can measure the electrode contact quality of all unipolar channels, including that of the Patient Ground and Common Reference electrode.

The impedance mode is activated in the application software. The impedance value ranges from 0 kΩ to 500 kΩ and is an indication of electrode contact quality, where lower values indicate better electrode contact. If the impedance measurement indicates 500 kΩ as value, there is no contact between skin and the electrode. If electrodes do not make good contact effects that may appear are increase of noise,

USER MANUAL SAGA

of 48

mains interference (50/60 Hz) or in electrodes that toggle around the edge of connection/disconnection.

Recovery of lost data In measurement scenarios where data could be lost, for example in a portable set up over Wi-Fi, the device has a back-up functionality that allows to retrieve lost data after the measurement session ends.

The Docking Station keeps track of any data that is missed in the status channel. Data that is missed is marked as ‘Dummy data’. The Data Recorder stores all measurement data on the on-board memory for the duration of the measurement session. After the session, ‘Dummy data’ can be replaced by the actual data from the on-board memory.

A measurement session is ended when the user stops the session by hand or when the Data Recorder stops recording on memory when 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, the Data Recorder may continue to acquire data on its on-board memory. The recording can then only be stopped by pressing the Recording button and Event marker button for 4 seconds. The recorded data can be subsequently downloaded when the Docking Station and Data Recorder connection is restored.

Because data loss in stationary setups is unlikely, it is not recommended to log all measurement data on the on-board memory. This will generate large files which are in many cases useless. In rare cases where external factors such as a power cut or accidental disconnection of the optical fiber is imminent and data loss is unacceptable, the operator should take appropriate actions to minimize these external factors.

USER MANUAL SAGA

of 48

Status Events The channel ‘STATUS’ can record several events. These events may be user triggered or triggered by the device itself. The events are used to provide information about what happened with the device during recordings. The following status events are available.

Status Event Origin Bit # Meaning

Marker event User 0 0 = No marker event

1 = Event marker button pressed

Reference mode User 1 0 = Average Reference mode

1 = Common Reference mode

Reference switch Device 2 0 = No switch event 1 = Automatic switch from Common Reference to Average Reference mode

Average Reference removal

Device 3 0 = Average removal is enabled

1 = Average removal is disabled

Synchronisation Out

Device 4 0 = Sync-Out is idle

1 = Sync-Out is active

Dummy data Device 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 Device 10 0 = Not receiving live data

1 = Receiving live data stream

Bat1 low Device 14 0 = Battery 1 is not low, or not present

1 = Battery 1 is low (needs replacement)

Bat2 low Device 15 0 = Battery 2 is not low, or not present

1 = Battery 2 is low (needs replacement)

Event marker Button The Event marker button on the device (marked SAGA 32+ or SAGA 64+ depending on the device type) can be used to set a marker event in the STATUS channel. This marker event is sampled synchronously to the other data. Pressing this button also creates a trigger on the synchronisation output of the device, this is a configuration option in the application software.

Typical use of this button is to mark a specific event during an ambulatory measurement, so this event can be looked up afterwards.

USER MANUAL SAGA

of 48

Reference Mode/Switch The Reference Mode event is set by the user in the application software. It shows if the data is recorded using the Average Reference or Common Reference input. See 6.3 for more information about using reference modes.

When the reference electrode loses contact to the REF input, the amplifier switches back to Average Reference mode within a few samples, marked in the Reference switch bit. If the reference channel comes back in range, the reference mode will NOT switch back again. This prevents data to be unusable in case the reference electrode becomes detached, but still makes contact to the skin. This could lead to switching references throughout the total recording, which is undesirable.

During post-processing of the data, it is important 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 from an external source. The digital input is an isolated input so a TTL level signal can be used to mark specific timepoints. The trigger is sample synchronous to all the other data.

Battery low The Data Recorder runs on one or two batteries. In case two batteries are used, they are drained on an ‘equal level’ basis. This means that the battery with the highest charge level is drained until they reach an equal level (in case of using batteries with unequal battery charge levels).

When the battery charge becomes low, the Data Recorder logs an event, marking which of the batteries is low. One or both batteries should be replaced or recharged.

When the batteries are empty, the Data Recorder logs a ‘battery empty’ event. The Data Recorder will close any running data acquisition session and power down.

USER MANUAL SAGA

of 48

6 OPERATIONAL PRINCIPLES

SAGA Device SAGA is an amplifier for electrophysiological measurements designed for optimal signal quality. The SAGA amplifier is characterized by low input noise, high input impedance and high common mode rejection. It is a true DC reference amplifier with high resolution and uses active signal shielding to minimize electrode cable capacitance and thereby minimizes cable movement artefacts and sensitivity to mains interference (50/60 Hz).

The SAGA Device consists of a Data Recorder and Docking Station. The Data Recorder’s main function is to capture and digitize electrophysiological signals and/or sensor data. The Docking Station acts as the receiver of the data and relays it to the data acquisition PC.

SAGA is an all-in-one solution for research and clinical applications that can be used as stationary, portable and ambulatory measurement device. The device is a medical device and can therefore also be used in clinical environments and for research in clinical settings.

The unipolar channels of SAGA are configured as an Average Reference amplifier but can also be configured as a Common Reference amplifier. The device is also equipped with two dual bipolar inputs for supplementary measurements and three triple auxiliary inputs to connect sensors and a digital input.

Application software installed on the computer controls the SAGA measurement functions.

Unipolar input channels The input stage for measuring unipolar electrophysiological signals is configured as an Average Reference amplifier. All signals are amplified against the average of all connected unipolar inputs. Inputs that are not connected to an electrode are automatically switched off. These channels will show a flat line signal.

Reference In case the device is configured for Common Reference measurement, the unipolar inputs are referenced against that electrode. In case the connection of that reference input is lost, the device will continue on as an Average Reference amplifier.

An Average Reference is recommended to use, as it does not depend on a separate reference electrode and location of a reference electrode. However, for some applications the Common Reference configuration could be preferred. This decision is left to the researcher/clinician.

Active signal shielding All electrode cables are shielded with the electrode signal itself (active shielding). The active shielding ensures that disturbances such as cable movement artefacts and mains interference (50/60 Hz) are reduced to a minimum. No filters that can cause a significant or frequency dependent behaviour within the analogue bandwidth are present in the device. There are no notch filters built into the device.

USER MANUAL SAGA

of 48

Bipolar input channels The bipolar inputs of SAGA are designed to measure electrophysiological parameters such as ECG, EMG or EOG, using two electrode connections per bipolar input. The inputs are configured as a differential amplifier with as output the potential difference between the two electrodes. Also, here, the amplifier is characterized by low noise, high common mode rejection and high resolution.

Each input is shielded with the mean of the two input signals. When one of the inputs falls of, the channel goes in overflow and will show a flat line signal.

Auxiliary input channels The auxiliary inputs of SAGA are designed to measure physiological parameters that (may) require a transducer, such as pressure, angle, acceleration, temperature or skin conductance. The auxiliary inputs are configured as amplifiers with wide input voltage range to capture the output voltage of the transducers incorporated into sensor accessories. Additionally, the connectors contain power supply, for transducers that require electric energy for their operation.

Each auxiliary input connector contains three such amplifiers to accept sensor accessories with up to three separate transducers, or e.g. a single 3D-accelerometer. Each connector also contains 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 read out and made available to the application software. Please refer to the datasheet of your sensor to see what data is provided to the software.

Tips for obtaining optimal quality data Placement of device Mains interference (50/60 Hz) is coming from external sources. This can be many things. It is a common mistake to state that battery powered devices are not susceptible to mains interference and devices powered from mains are. Mains interference can get into your measurement system via multiple ways, for example if you place your device on a metal table with other electrical equipment on it.

Optimal placement of systems will increase the quality of the acquired data. The ideal measurement setup is on a non-conducting (wood) or well-earthed table. Mains cables and power adapters should be placed on the floor or at least not on the same table as the measurement system.

Patient Ground connection From all electrodes that are connected for a measurement, the Patient Ground electrode is the most important one. TMSi recommends to use a (wetted) wristband, or to clean/prepare the skin as good as possible for optimal skin contact to e.g. electrode patches. Higher Patient Ground electrode impedance may cause more mains interference in all of the measurement electrodes.

USER MANUAL SAGA

of 48

Electrode materials SAGA is a DC-coupled amplifier with a high input range of +/-150 mV. This is more than sufficient for common measurement setups. The electrode-skin interface will act as a battery which causes a DC-shift in the signal of several millivolts up to a few hundred. If all electrodes, including Patient Ground, are made of the same material, this will not be a problem at all. If materials are mixed (for example gold electrodes or platinum electrodes are used in combination with Ag/AgCl electrodes, the DC shift can cause that channels go out of range of the amplifier.

Different electrode materials have different DC characteristics. Some materials may drift a lot, whereas others are fairly stable over time. Ag/AgCl is known to be a very DC-stable material and is used in most of the commercially available electrodes for contacting intact skin.

SAGA is also available in other configurations with a higher input range (up to +/-600 mV) which allows the use of different materials without saturations. Contact [email protected] for information 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 interface. This can be prevented by making a strain relief loop in the cabling. If for some reason the cable is pulled, the strain relief prevents that the cable also pulls on the electrode, causing artefacts. Cable movement in itself is not a problem thanks to SAGA’s active shielding technology.

Rereferencing/Artefacts If during a measurement an electrode is causing artefacts in the data it may be necessary to exclude this electrode from the measurement data. SAGA measures its signals against the average of all connected electrodes. This means that if an electrode becomes disconnected, this electrode is immediately taken out of the average calculation. If a channel needs to be excluded from the measurement ensemble, follow the steps below:

1. Identify the channels that are to be excluded from the measurement ensemble.

2. In the measurement data processing create a new signal by taking the average of all electrodes except those that are to be excluded.

3. Subtract the values of (2) from each electrode.

These steps are called rereferencing: a recalculation of the reference signal.


USER MANUAL SAGA

of 48

7 MAINTENANCE

Servicing and Updates The product does not contain user serviceable parts. Maintenance is limited to cleaning at user discretion. Repairs can only be performed by the manufacturer, contact [email protected] in case the product needs to be repaired. TMSi Support staff will determine whether a repair is required and possible.

The product does not require regular servicing or re-calibration during its expected service life.

Bug fixes or improvements to the firmware may become available for download from the website (www.tmsi.com). This update can be performed by the user. Follow the instructions accompanied with the update package carefully. Not complying with these instructions may cause the device to become unusable.

Cleaning instructions

• Before cleaning, make sure the product is switched off and not in contact with a patient.

• Use only tap water, if necessary with a mild detergent, applied through a 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 necessary. Other disinfectants may damage the product.

• Do not sterilize the product.

Disposal instructions Environmental protection

Special EU instructions for disposal are applicable to a product on which this symbol is placed. These instructions apply to all parts of the product. When the product has reached End of Life, it must not be disposed of with other waste. Instead, it is the user’s responsibility to dispose of their waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can dispose of your waste equipment for recycling, please contact your local city office, your household waste disposal service, or TMSi.



USER MANUAL SAGA

of 48

8 ELECTROMAGNETIC GUIDANCE

Degradation of performance Electromagnetic disturbances, such as electrostatic discharge, mains supply overvoltage spikes and mains interruptions may cause the following types of degradation of performance:

• Noticeable artefacts on signals. These should be discarded because they are clearly non-physiological signal traits.

• Transient interruptions of signal data communication; in extreme cases, cessation of data communication. Data does not appear on screen, but signal acquisition continues and signal data is recorded as indicated by the blinking green Card Recording indicator on the Data Recorder. The product has a provision for repairing data lost in communication. Refer to chapter 5.6 for data repair.

• As a result, the SAGA product may need to be restarted (recycle power).

Basic safety is not affected by these phenomena, and the effect on essential performance can be mitigated by user actions. To prevent electrostatic discharges relocate the measurement 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 can be found in the tables on the following pages.

Portable and mobile RF communications equipment can affect the performance of the SAGA product by:

• Disturbing data communication within the system. This may cause loss of measurement data for real-time processing or display on the PC. But the signal data can be repaired as described in chapter 5.6.

• Increasing noise level on signals, large offset shifts or causing signal distortion in extreme cases.

Basic safety is not affected by these phenomena, and the effect on essential performance can be mitigated by user actions. To prevent their interference, keep portable and mobile RF communications equipment at sufficient distance from the product.

The product needs special precautions regarding EMC and must be installed and put into service according to the EMC information outlined on the next pages.

Note that the SAGA Docking Station is intended to be used only in professional healthcare environments. The SAGA Data Recorder may also be used in domestic areas.

USER MANUAL SAGA

of 48

Electromagnetic emission Guidance and manufacturer’s declaration – electromagnetic emissions

The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1 The product 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.

RF emissions CISPR 11

Class A (Docking Station) Class B (Data Recorder)

NOTE The EMISSIONS characteristics of the Docking Station make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) it might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting it. The Data Recorder is suitable for use in all establishments, including domestic establishments 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 emissions IEC 61000-3-3

Complies

Electromagnetic immunity Guidance and manufacturer’s declaration – electromagnetic immunity


Immunity test IEC 60601-1-2 test level Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±8 kV contact

±15 kV air

±8 kV

±15 kV

Degradation of performance may occur: Electrostatic discharges may result in air sparks at connectors coincident with signal loss. Sometimes a measurement restart is required. For further information refer to chapter 8.1. Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Radiated RF EM fields IEC 61000-4-3

10 V/m (80 to 2700) MHz 80 % AM at 1 kHz

10 V/m Degradation of performance may occur: Electromagnetic radiation may distort and disturb acquired signals. At some frequencies the live communication link may be interrupted. For further information refer to chapter 8.1.

USER MANUAL SAGA

of 48

Guidance and manufacturer’s declaration – electromagnetic immunity




Proximity fields from RF wireless communications equipment IEC 61000-4-3

27 V/m At 385 MHz, 1.8 W, 18 Hz pulse modulation

28 V/m At 450 MHz, 2 W, 1 kHz sine FM modulation with ±5 kHz deviation

9 V/m At 710 MHz, 745 MHz and 780 MHz, 0.2 W, 217 Hz pulse modulation

28 V/m At 810 MHz, 870 MHz and 930 MHz, 2 W, 18 Hz pulse modulation

28 V/m At 1720 MHz, 1845 MHz and 1970 MHz, 2 W, 217 Hz pulse modulation

28 V/m At 2450 MHz, 2 W, 217 Hz pulse modulation

9 V/m At 5240 MHz, 5500 MHz and 5785 MHz, 0.2 W, 217 Hz pulse modulation

27 V/m

28 V/m

9 V/m

28 V/m

28 V/m

28 V/m

9 V/m

Degradation of performance may occur: Electromagnetic radiation may distort and disturb acquired signals. At some frequencies the live communication link may be interrupted. For further information refer to chapter 8.1. Portable and mobile RF communications equipment should be used no closer to any part of the product, including 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: Electrical transient pulses on AC mains and USB connection may cause signal loss and require a measurement restart in wireless operation. In docked operation transient signal interruptions during pulses may occur. For further information refer to chapter 8.1. Mains power quality should be that of a typical commercial or hospital environment.

Surges IEC 61000-4-5

±1 kV Line-to-line

±2 kV Line-to-ground

±1 kV

±2 kV

Degradation of performance may occur: During surges transient signal interruptions may occur. For further information refer to chapter 8.1. Mains power quality should be that of a typical commercial or hospital environment.

Conducted disturbances induced by RF fields IEC 61000-4-6

3 V 1 (0.15 to 80) MHz 80 % AM at 1 kHz

6 V 1 in ISM and amateur radio bands within (0.15 to 80) MHz 80 % AM at 1 kHz

3 V

6 V

Degradation of performance may occur: High level conducted disturbances on AC mains may cause data communication loss, on other connections including patient connections they may cause transient signal interruptions. For further information refer to chapter 8.1.

Rated power frequency magnetic fields IEC 61000-4-8

30 A/m 50 Hz or 60 Hz

N.A. 5 The product is not intended for environments with restricted access due to strong magnetic fields.

USER MANUAL SAGA

of 48

Guidance and manufacturer’s declaration – electromagnetic immunity




Voltage dips IEC 61000-4-11

0 % UT 2; ½ cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0 % UT 2; 1 cycle and 70 % UT 2; 25/30 3 cycles Single phase: at 0°

0 % UT

0 % UT

Mains power quality should be that of a typical commercial or hospital environment.

Voltage interruptions IEC 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 product requires continued operation during power mains interruptions, it is recommended that the product be powered from an uninterruptible power supply or a battery.

Electrical transient conduction along supply lines ISO 7637-2

As specified in ISO 7637-2 N.A. 6

Notes: 1. This is the R.M.S. level, before modulation is applied. 2. UT is the A.C. mains voltage prior to application of the test level. 3. E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz. 5. Applies only to medical devices with magnetically sensitive components or circuitry. 6. Applies only to medical devices intended to be powered from 12/24 V road vehicle power systems.

USER MANUAL SAGA

of 48

9 TECHNICAL SPECIFICATIONS Use the REF number on the device label to identify the device configuration.

General Specifications Type SAGA 32+ 32 unipolar, 4 bipolar, 9 auxiliary, 1 digital

SAGA 64+ 64 unipolar, 4 bipolar, 9 auxiliary, 1 digital

REF See device label

Size (device only) Data Recorder: ᴓ 179 mm, height: 41 mm

Docking Station: ᴓ 179 mm, height: 47 mm

Weight Data Recorder: 0.7 kg (excluding batteries)

Docking Station: 0.7 kg

Power consumption Data Recorder:

<5 W on battery power

<10 W when docked, charging

Docking Station: 5 W to 25 W

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 Medical Device class • IIa (Rule 10) per MDD Annex IX and per MDR Annex VIII.

• II per 21CFR860

Power source External mains power supply and/or internal batteries

Mode of operation Continuous operation

Electric shock protection

Mains power supply: Class I

Applied parts: Type CF

Applied parts Refer to chapter 3.2.

Accessible parts Refer to chapter 3.2.

Ingress protection IP22 (Data Recorder) Protection against particulate matter with ≥12,5 mm diameter and against ingress of dripping water when 15° tilted

Mains power supply Brand, type SLpower, ME30B1548F02

For further information, including specification, refer to documentation and label of the mains power supply. (www.slpower.com )

http://www.slpower.com/

USER MANUAL SAGA

of 48

Battery Batteries 1 or 2 batteries

Power Saving 30 minutes (no connection to PC)

Battery low indication level 3.3 V

Battery empty shut down level 3.1 V

Brand, type RRC power solutions, RRC1130 For further information, including specification, refer to Manual and Data Sheet (www.rrc-ps.com) and label of the battery.

Communication Data Recorder to Docking Station Wi-Fi Band 2.4 GHz

Range 10 m

Power 16 dBm

Bandwidth Maximum 2 Mb/s

Security WPA2

Fiber Length Up to 20 meters


Electrical Bandwidth Maximum 30 Mb/s

Communication Docking Station to PC USB Standard 2.0

Ethernet Standard LAN, IEEE 802.3 10/100 Mb/s

Communication Docking Station to Remote Interface

Bluetooth Band 2.4 GHz

Range 10 m

Power 5.8 dBm


Transportation Conditions Temperature -20 °C to +60 °C

Humidity 15 % to 90 %, non-condensing

Pressure 500 hPa to 1060 hPa

Storage Conditions Temperature 0 °C to +40 °C



http://www.rrc-ps.com/

USER MANUAL SAGA

of 48

Usage Conditions Temperature Data Recorder (alone): +5 °C to +40 °C

Docking Station (alone): +5 °C to +30 °C

Docking Station + Data Recorder: +5 °C to +30 °C



Unipolar Channel Specifications Number of channels • SAGA 32+: 32

• SAGA 64+: 64

RMS noise (0.1 to 100) Hz

<1 µV

Input Range (Differential Mode)

-150 mV to +150 mV (@ 0 V common mode)

Input ranges up to +/-600 mV are 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 GΩ

Common Mode Rejection Ratio

100 dB (typical) @ 50/60 Hz

Amplifier concept • Average Reference amplifier, or

• Common Reference amplifier (when using Common Reference input)

Shielding Individual signal shielding

Analogue bandwidth DC to 800 Hz at highest sampling rate, 0.35 * sampling rate otherwise

Anti-alias filter 1.6 kHz low-pass

Impedance Mode Separate mode, including Patient Ground impedance measurement

Range 0 kΩ to 499 kΩ, (500 kΩ means not connected)

Accuracy 10 % of reading + 1 kΩ

Resolution 1 kΩ

USER MANUAL SAGA

of 48

Bipolar Channel Specifications Number of channels 4 (2 x dual channel input)


<1 µV

Input Range (Differential Mode)

-150 mV to +150 mV (@ 0 V common mode)

Input Range (Common Mode)

-2 V to +2 V (@ 0 V differential mode)

Resolution < 20 nV


Input resistance >1 GΩ

Common Mode Rejection Ratio

100 dB typical

Shielding Average signal shielding (+ and – inputs are shielded with average of + and – signal.)



Auxiliary Channel Specifications Number of channels 9 (3 x triple channel input)

Output Voltage +5 V, max 45 mA for all channels together


<20 µV

Input Range -3 V to +3 V

Resolution < 0.6 µV


Input resistance >0.5 GΩ



USER MANUAL SAGA

of 48

Channel Overview Name Connection Remarks

CREF REF and UNI 1-32

UNI 1 to

UNI 32

UNI 1-32

UNI 33 to

UNI 64

UNI 33-64 Only for SAGA 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 (with serial sensor)

SpO2

PLETH

HRate Stat

DIGI (with Saturation sensor)

X-AXIS

Y-AXIS

Z-AXIS

Internal 3D accelerometer

STATUS Internal

COUNTER Internal

TRIGGER DIGI

user manual saga - tmsi

Documents