TMSi Apex Manuale utente

REF 92-1300-0201-EN-7-0

REV 7

Last update: 2023-01-31

USER MANUAL

USER MANUAL APEX 
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TABLE OF CONTENTS 
1SERVICE AND SUPPORT 3 
 About this manual 3 
 Contact information TMSi 3 
 Warranty information 3 
 Additional accessories 4 
 Abbreviations 4 
2SAFETY INFORMATION 5 
 Explanation of markings 5 
 Limitations of use 6 
 Safety measures and warnings 6 
 Precautionary measures 7 
 Disclosure of residual risk 8 
 Information for lays 8 
3PRODUCT OVERVIEW 9 
 Product 9 
 Intended use 9 
 Product views 11 
 User interface 13 
 Connections 15 
 Triggering 17 
 Device labels 17 
4INSTRUCTIONS FOR USE 18 
 Power Apex 18 
 Connect accessories 18 
 Data connections 19 
 Software 19 
 Wearability 20 
 APEX in an ME system 21 
5PERFORM A MEASUREMENT 22 
 Perform Stationary Measurement 22 
 Perform Portable Measurement using Bluetooth 22 
 Perform Card recordings 23 
 Impedance Measurement 24 
 Status Events 24 
6OPERATIONAL PRINCIPLES 26 
 APEX 26 
 Unipolar input channels 26 
 Tips for obtaining optimal quality data 27 
7MAINTENANCE 28 
 Servicing and Updates 28 
 Cleaning instructions 28 
 Disposal instructions 28 
8ELECTROMAGNETIC GUIDANCE 29 
 Degradation of performance 29 
 Electromagnetic emission 29 
 Electromagnetic immunity 30 
9TECHNICAL SPECIFICATIONS 34 
 

USER MANUAL APEX

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1SERVICE AND SUPPORT

About this manual

This manual is intended for the user of the APEX (electro-)physiological amplifier

which is also referred to as ‘APEX’, ‘product’ or ‘APEX 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 familiarise yourself with the various controls and accessories before

starting to use the product.

Contact information TMSi

TMSi Support can be reached via email (supp[email protected]) or via the website:

www.tmsi.com/support. Please provide as much information as possible, including

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

possible.

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

Manufacturer

Contact Information

Twente Medical Systems International B.V.

Zutphenstraat 57

7575 EJ Oldenzaal

The Netherlands

[email protected]

www.tmsi.com

Warranty information

The product is warranted against failure of materials and workmanship for a period

of one year from the date of delivery.

Repairs can only be performed by the manufacturer or by TMSi authorised

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.

•Interrupted or erroneous 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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Additional accessories

In case you want to order additional accessories such as cables or sensors, please

contact sales@tmsi.com for consultation and a detailed quotation. The product is

intended to be used with approved headcaps only; the latest version of compatible

accessories can be found on the TMSi website www.tmsi.com.

Abbreviations

Abbreviation

Alternating Current

Body Floating

Bluetooth

Conformité Européenne

Direct Current

EEG

Electro-encephalography (Brain activity)

EM, EMC

Electro-magnetic, Electro-Magnetic Compatibility

EMG

Electromyography (Muscle activity)

EOG

Electro-oculography (Standing potential of the eye

between front and back)

European Union

Information Technology

Medical Equipment

Personal Computer

REF

Reference

Radio Frequency

Serial Number

SAR

Specific Absorption Rate

TMSi

Twente Medical Systems International B.V.

UNI

Unipolar

USB

Universal Serial Bus

USER MANUAL APEX

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2SAFETY 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

Refer to instructions for use (for USB-C connector function, chapter

4.6)

Type BF applied part

CE-certified, see declaration of conformity

Identification of the manufacturer

Date of manufacture (YYYY or YYYY-MM-DD)

Ingress protection rating (where N1and N2are one digit each)

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, see chapter 7.3

Wireless sensors status indicator; see chapter 3.4

Cap connection status indicator; see chapter 3.4

PC connection status indicator; see chapter 3.4

Recording status indicator; see chapter 3.4

Power status indicator; see chapter 3.4

Power button icon; see chapter 3.4

Marker button icon; see chapter 3.4

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Recording button icon; see chapter 3.4

Limitations of use

There are no known contra-indications to the use of the APEX product. For further

information refer to chapters 2.3, 2.4 and 3.2.

The design of this product did explicitly not account for potential applications, uses

or environments as listed below and therefore these aspects were excluded from full

risk assessment. In order to prevent any associated risks, the following limitations

apply to the product:

•This product is not intended for a medical purpose. This includes, but is not limited to, the

following:

- Direct diagnosis.

- Monitoring of vital physiologic processes.

- Critical applications.

- Life-supporting applications.

- Determination of electro-cerebral inactivity or silence.

•This product is not defibrillator-proof.

•This product is not intended for use in oxygen rich environments.

•This product is not intended for use in environments with flammable mixtures of anesthetics

or agents and air, oxygen or nitrous oxide.

•This product is not intended for use in environments with strong magnetic fields.

•This product is not intended for use in environments with ionizing radiation.

•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,

unless it is used in an environment where the air pressure is maintained within the range

(700 to 1060) hPa.

•This product is not to be used in the presence of Magnetic Resonance Imaging (MRI)

devices.

NOTE

While the product can be used to measure encephalic (brain) signals, it is NOT intended

to be used, alone or in combination with other devices or software, for diagnostic

purposes as an electroencephalograph (to produce an electroencephalogram).

Safety measures and warnings

Some risks associated with the intended use of the product cannot be eliminated in

the product design. To avoid consequential residual risks, the following measures

and warnings must be followed up for safe usage of the product.

Only use accessories explicitly approved by TMSi to avoid the risk of electric shock.

APEX is intended to receive its power from other electrical equipment in an ME

System if not powered from the internal battery. The electrical safety is dependent on

this other equipment. Refer to chapter 4.6 for further details.

To avoid the risk of electric shock do not connect APEX to equipment that is not

compliant with either IEC 60601, IEC 60950 or IEC 62368.

Do not touch pins of disengaged connector plugs or sockets to avoid the risk of electric

shock.

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Do not use APEX together with cautery or electro-coagulation equipment on the same

subject to avoid damage to the product.

To avoid damage to the product do not use or store it near sources with particle

radiation or elevated levels of electrical, magnetic or electro-magnetic fields.

To avoid damage and reciprocal interference, only connect TMSi approved

accessories and equipment to APEX.

Do not use APEX together with magnetic resonance imaging equipment on the same

subject to avoid reciprocal interference.

Do not tamper with any part of APEX. To maintain safety, no modifications are

allowed.

Use of APEX adjacent to or stacked with other equipment should be avoided because

it could result in improper operation. If such use is necessary, APEX 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 APEX could result in increased electromagnetic emissions or

decreased electromagnetic immunity of APEX 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 APEX including its cables. Otherwise, APEX performance degradation could result.

Conductive parts of electrodes and associated connectors should not contact other

conductive parts, including earth.

APEX is intended to be operated close to the human body and must comply with the

Specific Absorption Rate (SAR) for body worn equipment to ensure compliance with

RF exposure requirements set for the USA and Canada. When using APEX while

wearing it on the body, maintain a distance of 10mm between APEX and the body.

This can for instance be accomplished by using the APEX cradle with a 10 mm thick

adhesive foam pad, which must be free of metallic components, mounted to the

backside of the cradle. For use in the EU, there is no such requirement.

To further comply with FCC and Industry Canada RF radiation exposure limits for

general population, no transmitter or transmitter antenna must be co-located within 20

cm from the APEX.

Changes or modifications not expressly approved by the party responsible for

compliance could void the user’s authority to operate the equipment.

Precautionary measures

Taking the measures listed below should ensure proper operation and result in

minimal undesired consequences and optimum benefit of using the product.

Make sure batteries are sufficiently charged before wireless use of APEX. If

necessary, connect an external power bank for charging.

To prolong battery life, store APEX with preferably 40 % charged batteries and at a

temperature in the range (-20 to 20) °C.

To avoid signal disturbance, keep APEX away from sources of strong electric,

magnetic and electromagnetic radiation.

To avoid loss of data, use USB communication for data transport and control.

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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 bandage.

If any part of APEX appears obviously malfunctioning or damaged, refrain fromfurther

using it and contact the manufacturer for repair and check of the device.

When using APEX in combination with a laptop that is connected to external equipment

(monitor, ethernet, etc), please ensure that the laptop is grounded in order to avoid

possible signal interference.

When using APEX in combination with a laptop/PC or charger, make sure that the

product is not positioned in such a way that it is difficult to operate the disconnection

device.

Disclosure of residual risk

The intended and foreseeable use of the APEX product bears an acceptable risk.

Residual risks are disclosed in chapter 2.3.

Information for lays

In case of subject use, the user of the product should instruct the subject on the

following topics:

•There are no contra-indications on the use.

•Do’s and don’ts regarding use and usage environments. Specifically:

a. Keep the product clean and dry.

b. Do not enter areas and environments where access is restricted.

c. Keep distance from professional and amateur transmission

antennas.

d. When interacting with children or pets, be careful about pulling at

cables.

•Which indicators, if any, must be monitored, how often, and how to react

on specific status indications.

•When to press the Event marker button.

•How batteries have to be recharged, if their running out is expected.

•Contact the researcher when an unexpected situation or problem occurs.

USER MANUAL APEX

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3PRODUCT OVERVIEW

Product

The APEX product consists of the following components:

•APEX Recorder: Electro-physiological amplifier.

•Accompanying documentation: Quick start guide, User Manual and

certificates.

•TMSi APEX Device Driver.

•TMSi BT Dongle.

The product is delivered with the following items to increase the ease of use: a

suitcase, USB-C to USB-A cable, the APEX Cradle, some subject cabling and the

TMSi Python Interface including a compiled application that provides a Graphical

User Interface.

The product is intended to be used with approved headcaps; the latest version of

compatible accessories can be found on the TMSi website www.tmsi.com. Please

refer to the instructions for use of those accessories, if applicable.

Intended use

The product is intended for acquisition of human electroencephalographic (EEG)

signals within the product’s technical limitations as specified in chapter 9

Furthermore, the product is designed to log external trigger events.

The product is not intended for a medical purpose (diagnostic, monitoring or

treatment).

Subject population

The product is intended to be used by research professionals in a laboratory

environment. APEX is also intended to be used for out-of-lab measurements. For

this use case, the research professional configures the product, after which it can be

handed to the subject. Data can be retrieved afterwards from the onboard memory.

There are no restrictions on the subject population for which the product can be used.

The product can be used on subjects regardless of age, gender or other criteria.

Subject interface and operating principle

The product can be worn on the body during wireless measurement setups in which

case its enclosure outside is an accessible part. Contact between the subject and

product’s subject input(s) is made by using accessories such as headcaps, in

combination with gel or saline water.

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.

USER MANUAL APEX 
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Applied part 
The product has a single Type BF applied part. It consists of the front-side sockets 
(pins and shield) on the product enclosure that are marked with an applied part 
symbol, because these parts of the device connect galvanically to the EEG 
accessories. 
User population 
The product is intended to be used by, or under supervision of, a physician or 
research professional. The user/supervisor must have knowledge of current good 
practice in physiological measurement applications. 
User interface 
The different user interfaces of the product are: 
•The user interface of the APEX. 
•The API offers a method to interact with the device from a PC. The 
application software’s user interface provides the various functionalities. 
The user interface of the APEX consists of an Event marker button, a Recording 
button, a Power button and 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. 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 professional research laboratory 
environment, within environmental limits as specified in chapter 9. The product can 
be used as both a stationary device, as well as a portable device. Usage in 
environments with restricted access due to ionizing radiation and/or strong magnetic 
fields is excluded, as well as usage in situations referred to in chapter 2.2. 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 APEX. 
APEX is also suitable for out-of-lab usage. Setting up card recordings is explained 
in chapter 5.3. After being instructed how to deal with the device, the subject can be 
sent out for a while and during that time the APEX autonomously carries out the 
measurement as configured. Refer to chapter 2.6 for the instructions for lays. 
Only use the product with the supplied parts and accessories. In case other parts or 
accessories are required, contact TMSi Support (sup[email protected]) for information. 
Expected service life 
The expected service life of the device is 5 years. If the product is intended to be 
used after its expected service life, contact TMSi to have the product inspected 
before continued use. 