MANUAL

BTL FLEXI 12 ECG

USER’S MANUAL
BEFORE YOU START

Dear customer,

Thank you for purchasing BTL technology. All of us at BTL wish

you every success with your system. We pride ourselves on
being as responsive as possible to our customers’ needs.

Your suggestions and comments are always welcome, since we

believe an ongoing relationship with our customers is critically
important to our future product line.

While we would like you to start using your new equipment right
away, we encourage a thorough reading of this manual in order
to fully understand the operational features of the system.

Please visit our corporate website at http://www.btlnet.com for

the latest information on BTL products and services.

Again, thank you for being a BTL customer.

BTL Industries Limited

CONTENTS

1 GENERAL CHARACTERISTIC.......................................................................................................................... 6
1.1 Intended use ................................................................................................................................................. 6
1.2 User profile .................................................................................................................................................... 6
1.3 Operating environment .................................................................................................................................. 6
1.4 Patient profile ................................................................................................................................................ 6
1.5 Indications ..................................................................................................................................................... 6
1.6 Contraindications........................................................................................................................................... 6
1.7 Possible side effects...................................................................................................................................... 6
2 SAFETY PRECAUTIONS ................................................................................................................................... 7
3 USED SYMBOLS AND MARKINGS ................................................................................................................ 12
4 SYSTEM OVERVIEW ....................................................................................................................................... 13
4.1 Buttons ........................................................................................................................................................ 14
4.2 Device labels and charging point ................................................................................................................ 14
4.3 Indicators ..................................................................................................................................................... 15
4.4 Patient cables .............................................................................................................................................. 16
5 SETUP AND START UP .................................................................................................................................. 17
6 CONTROLS DESCRIPTION ............................................................................................................................ 18
6.1 Menu screen – device ................................................................................................................................. 18
6.2 Recording screen – device .......................................................................................................................... 18
6.3 History screen – device ............................................................................................................................... 19
6.4 Settings – device ......................................................................................................................................... 20
6.5 Login screen – application........................................................................................................................... 20
6.6 Recording screen – application ................................................................................................................... 21
6.7 Patients card screen – application............................................................................................................... 22
6.8 Settings – application .................................................................................................................................. 22
7 ECG RECORDING WITH THE SYSTEM ......................................................................................................... 23
7.1 Positioning of electrodes ............................................................................................................................. 23
7.2 Connecting the application to the device ..................................................................................................... 24
7.3 Enter patient information and start recording .............................................................................................. 24
7.4 ECG recording and review .......................................................................................................................... 25
7.5 Printing and sharing ECG ............................................................................................................................ 25
7.6 Managing ECG history ................................................................................................................................ 26
8 FILTERS ........................................................................................................................................................... 27
8.1 Predefined filters ......................................................................................................................................... 27
8.2 User filters ................................................................................................................................................... 28
9 TROUBLESHOOTING ..................................................................................................................................... 30
10 MAINTENANCE ............................................................................................................................................... 31
11 ACCESSORIES ................................................................................................................................................ 32
12 TECHNICAL PARAMETERS ........................................................................................................................... 33
12.1 Electromagnetic compatibility (EMC) ........................................................................................................... 34
13 MANUFACTURER ........................................................................................................................................... 38

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 5 OF 40

 1 GENERAL CHARACTERISTIC
The BTL Flexi 12 ECG is an ECG system (hereinafter referred to as ‘ECG system’) composed of the portable
handheld BTL Flexi 12 ECG acquisition device (hereinafter referred to as ‘device’) and the BTL CardioPoint Flexi
software application (hereinafter referred to as ‘application’) running on a tablet.

The device records ECG data of a patient through ECG Patient Cable and Electrodes applied to the Patient.
These ECG data are simultaneously transmitted to the application via Wi-Fi network for further analysis and
presentation.

1.1 INTENDED USE

The BTL Flexi 12 ECG is intended for acquisition, processing, recording, analysis and presentation of ECG data
for diagnostic purposes.

1.2 USER PROFILE

The BTL Flexi 12 ECG shall be used by medically educated personnel. The user shall be familiar with all safety
precautions, operating procedures and maintenance instructions given in this User’s Manual.

1.3 OPERATING ENVIRONMENT

The BTL Flexi 12 ECG is intended to be used primarily in hospitals, but it can also be used in clinics, medical
centres or wherever the ECG examinations are performed. The BTL Flexi 12 ECG is not intended for home use.

1.4 PATIENT PROFILE

The BTL Flexi 12 ECG can be used on all adult and paediatric patients without limitation of age, gender, weight,
height, etc.

1.5 INDICATIONS
The indications for electrocardiography include, among others, assessment of presence, absence or condition
change of:
 arrhythmias,
 conduction defects,
 chamber enlargement,
 myocardial hypertrophy,
 myocardial ischemia,
 myocardial necrosis,
 pericardial inflammation,
 electrolyte disturbance,
 neurohumoral influence.

1.6 CONTRAINDICATIONS
There are no known contraindications for resting ECG examinations.

1.7 POSSIBLE SIDE EFFECTS

There are no known possible side effects for resting ECG examinations.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 6 OF 40

2 SAFETY PRECAUTIONS

Read the user’s manual carefully and become familiar with all its safety requirements,
operating procedures and maintenance instructions before using the ECG system. It is
prohibited to use the ECG system and its accessories in any manner that is not in
accordance with the user’s manual.

Any other application of data and reports other than its intended use is not advised and
considered a misuse of the ECG system. The ECG system is not intended for Direct Cardiac
Application and home use.

The ECG system and accessories should be kept away from any liquids to avoid accidental
spillage on components. Penetration of liquid in the device may cause it to malfunction or
may generate electric shock.

Use the ECG system under safe operating environment as specified in the manual. The
system must not be used around flammable anaesthetics or oxidizing fluids (O2, N2O, etc.).

Do not operate the ECG system with any external devices generating magnetic and electrical
fields and high-frequency signals. This may cause undesirable mutual interference and will
hamper the functioning of the ECG system.
Thoroughly inspect the ECG system before each use. Check for any physical damage, loose
connections, distorted display and any other inconsistency or abnormality. Stop using the
ECG system if the behaviour differs from the function described in this manual or the
labelling on the device/accessory is unclear for use. Try to determine and solve uncertainty
by referring to section “Troubleshooting”. Immediately contact the authorized BTL service
department for additional support.

It is not recommended to use the ECG system together with other devices than stated in this
User’s Manual.

The ECG curves displayed by the acquisition device are informative only and do not fulfil the
requirements for applicable ECG standards. Always use the BTL CardioPoint Flexi SW
application for analysis of patient data.

The device does not carry any risk to patients with cardiac pacemakers.

Device and defibrillation precautions

The ECG system is designed for use with the defibrillator. The used defibrillator must comply
with the applicable standards and its discharge must correspond to what is described in the
applicable standards. The ECG system is resistant to defibrillation only if the original BTL
patient cable is used.

Stay away from the patient or patient cables during defibrillation procedure. A defibrillator
may generate electric shock and coming in contact may cause serious injury or death.

The device should be used in accordance with the operations described in this manual.

Use “Docking station” or “Power Cord & Power Adapter set” provided along with the ECG
system to charge device’s battery. Do not use any other non-approved cables or means for
charging. This may cause damage to the device. Refer to the section “Troubleshooting” in
this manual for any uncertainties. Contact the authorized BTL service department for
additional help.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 7 OF 40

Parts and accessories
Patient cables

Use only parts and accessories supplied along with the ECG system. Any external part
related to the ECG system must meet the safety requirements according to the applicable
standards.

Do not touch exposed ends of lead wires or connector pins and patient simultaneously.
Ensure that the accessible ends of the leads do not meet other conductive materials.

Always clean and disinfect reusable leads and connectors with recommended chemicals
before patient use. Failure to do so may cause transfer of infection between patients.

High-frequency burns - using cables not supplied with this equipment can lead to a serious
injury. Use only patient cables that are shipped with this equipment.

Ensure that the ECG leads are securely connected to the device. Obey the marking on the
socket for proper connection. Loose or improper connection cause inaccuracies in acquiring
and processing ECG data.

Periodically inspect the ECG leads. Do not use any damaged or broken leads. Contact the
authorized BTL service department for replacement of damaged leads.

Always follow IEC or AHA standard guidelines while connecting the ECG leads to the
electrodes placed on patient’s skin. Follow the colour markings provided on the ECG leads.

Power adapter and battery

The “docking station” or the “device” is connected to the AC power supply through a power
adapter. Use the medical grade power adapter supplied along with the ECG system for
charging the device’s battery. Using other means or cables for charging may damage the
device and the charging station.

Check if the parameters of the mains, AC voltage and Frequency, etc. correspond to the
requirements of the ECG system in the section “Technical Parameters”. Do not connect the
system in case of any non-compatibility. Refer to the section “Troubleshooting” in this manual
for making appropriate adjustments in the device. Contact the authorized BTL service
department for additional help.

A faulty adapter or battery replacement should be attended only by the BTL authorized
service department. Using non-approved batteries or adapters and replacement done by
unauthorized personnel can damage the device.

If the battery leaks and gives off an unusual smell, power off immediately and stop using the
device. Contact the authorized BTL service department for attention and support.

Electric Shock — Improper connection of the system or the device may cause electric shock.
To avoid the risk, the device must only be connected to supply mains with a protective earth.

Do not position equipment in a way that makes it difficult to disconnect the device when using
an appliance coupler, mains plug, or another separable plug as a means of isolation.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 8 OF 40

Application on tablet

Follow recommended installation procedure. Acquiring and installing the application from any
other sources is strictly prohibited and can damage functioning of the ECG system.

To avoid loss of data, it is recommended to back up acquired ECG data and patient
information from the application.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 9 OF 40

FCC & ISED Compliance statement

This device complies with Part 15 of the FCC Rules.

Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may cause undesired
operation of the device.

FCC caution!
Any changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate this device.

Part 15B compliance statements for digital devices:

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy,
and if not installed and used in accordance with the instruction manual, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation.
However, if this equipment does cause interference to radio or television equipment reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:

 Reorient or relocate the receiving antenna.

 Increase the distance between the equipment and the receiver.

 Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.

 Consult the dealer or an experienced radio/television technician about help.

 Use a shielded and properly grounded I/O cable and power cable to ensure compliance of this unit with the
specified limits of the rules.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 10 OF 40

ISED statements

This Class B digital apparatus complies with Canadian ICES-003. This device complies with Industry Canada
license-exempt RSS standard(s). Operation is subject to the following two conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired operation of
the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de
licence. L'exploitation est autorisée aux deux conditions suivantes:
1. l'appareil ne doit pas produire de brouillage, et
2. l'utilisateur de l'appareil doit accepter tout brouillage adioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.

Attention!

Toute modification ou modification non expressément approuvée par la partie responsable de la conformité
pourrait annuler l'autorisation de l'utilisateur d'utiliser cet appareil.

REMARQUE: Cet équipement a été testé et s'est déclaré conforme aux limites d'un appareil numérique de classe
B, conformément aux règles ISED. Ces limites sont conçues pour fournir une protection raisonnable contre les
interférences nuisibles dans une installation résidentielle. Cet équipement génère, utilise et peut émettre de
l'énergie radiofréquence, et s'il n'est pas installé et utilisé conformément au mode d'emploi, il peut causer des
interférences nuisibles aux communications radio. Cependant, il n'y a aucune garantie que des interférences ne
se produiront pas dans une installation particulière. Toutefois, si cet équipement cause des interférences à la
réception de l'équipement de radio ou de télévision, ce qui peut être déterminé en allumant et éteindre
l'équipement, l'utilisateur est encouragé à essayer de corriger les interférences en prenant une ou plusieurs des
mesures suivantes:

 Réorientez ou déménagez l'antenne de réception.

 Augmenter la séparation entre l'équipement et le récepteur.

 Connectez l'équipement à une prise de courant sur un circuit différent de celui auquel le récepteur est
connecté.
 Consultez le revendeur ou un technicien en radio / télévision expérimenté pour obtenir de l'aide.

 Utilisez un câble d'E / S blindé et correctement mis à la terre et un câble d'alimentation pour assurer la
conformité de cet appareil aux limites spécifiées des règles.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 11 OF 40

3 USED SYMBOLS AND MARKINGS

Caution

Warning

Type BF applied part

Defibrillation-proof type CF applied part

Read the manual and follow its instructions before using the device

Electrical and electronic equipment waste

Name and address of the manufacturer

Date of manufacturing

Serial number

Batch code

Catalogue number

The Ingress Protection code for this device is IPX2

Protection against solid foreign objects - no specified protection
IPX2 Protection against liquid - against vertically falling drops of water, if the case is tilted up to 15
degrees from vertical

DC Voltage In

Chassis – connection of sensitive electrical circuits to the chassis

CE mark

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 12 OF 40

4 SYSTEM OVERVIEW
This section of the manual describes the ECG system components and its physical characteristics in detail.

1. BTL Flexi 12 ECG device for ECG acquisition with display with touch panel for 12L waveform view only.
2. Docking station for charging.
3. Patient Cables (6L and 4L cables)
4. Electrode set - clamp
5. Power adaptor. Can be connected to the docking station or to the device for charging.
6. Electrode set - bulb
7. BTL CardioPoint Flexi application (Installed on recommended tablet devices)

This product meets the applicable national or international RF exposure guidance (SAR guideline)
when used normally, held near the body or when worn or carried, at the distance of 1.5 cm or more
from the body. The SAR guideline includes a considerable safety margin designed to ensure the
safety of all persons, regardless of age and health.

Always install the docking station away from an edge of the table, safe enough to prevent accidental
drop of the device or the docking on the operator.

In the event of any fluid spillage on the device, move the device immediately away from the spillage
area. Thoroughly wipe and dry all wet surface of the device including patient cable holder area. Allow
sufficient time for the device to dry before reuse.

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4.1 BUTTONS

1. On/off button

2. Record/back button

Operation Recording screen Other screens

Short press Display off Display off
On/off button
Long press Device off Device off
Short press Record Back
Record/back button
Long press No function Back to recording screen

4.2 DEVICE LABELS AND CHARGING POINT

1. Serial label

2. Device rating label

3. Connection point for charging

Always use the medical grade power adapter supplied along with the ECG system for charging the
device’s battery. Using other means or cables for charging may damage the device and the charging
station.

For disposal of the device follow local environmental guidelines concerning disposal and recycling
instructions.
Do not dispose the battery in fire. Explosion hazard – batteries may explode in fire.

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4.3 INDICATORS

1. Battery status
a. Low battery capacity: Permanent blinking (when battery capacity is less than 20%)
b. Battery charging: Permanent orange light
c. Battery failure: Permanent blinking
d. Battery fully charged (when charger connected): Off.
2. Switch-on indicator (indicates that the device is ready for use)
3. Signalization status. Some of the signalization, like WiFi connection and disconnection, can be
accompanied by a sound indication.

Battery indication

An internal rechargeable battery powers the device Symbol Battery status

during its operation. The device also serves as an Charger connected
inbuilt protection circuit to protect the battery against
overcharging and short-circuits. The battery symbol 100–76%
and a numerical value on the screen indicate the
remaining battery power. 75–51%

50–26%
A fully charged battery can last up to 6 hours under
normal usage conditions. The battery requires 25–11%
approximately 8 hours of charging to reach >90%
capacity in a turn-off condition. 10–0%

Indication that battery is

damaged or removed

The device can also be powered directly from AC mains when the battery failure occurs or in case the battery is
not present in the device. In such case, the device is connected directly to AC mains through a medical grade
power adapter. A docking station connected to the power adapter can also be used to alternatively connect the
device to AC mains.

When a battery failure occurs, it is recommended to contact the BTL Authorized service. Such a situation is
indicated by the LED and on-device display as well.

Usage during charging without internal rechargeable battery or under a no-battery condition will lead
to patient data loss in the event of any mains power failure.

If excessive device temperature is observed while using the device, stop using the device and switch
off the device for at least 30 minutes to allow cooling of the device before the next use.

For continuous usage of the device for longer durations of more than 2–6 hours it is recommended to
operate the device in environment with temperature around 35 °C.

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4.4 PATIENT CABLES
Cable holder area

1. 4-lead patient cable holder area

2. 6-lead patient cable holder area

Patient cables

1. Device side connection – 6-lead and 4-

lead type cables

2. Electrode side connection – 6-lead and

4-lead type cables

B Banana-type connection for reusable

electrodes.
P Pinch or snap-type connection for
disposable electrodes.

Warranty for a patient cable is 6 months in normal use. Typical normal use is 30 ECG examinations
per day with proper cleaning, as specified in this manual.

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5 SETUP AND START UP
Unpack the device from the packaging to setup the device and accessories. Install the application on a device in
the list of recommended devices.

Recommended list of tablet devices:

Mobile device Supported operating system

Apple iPad Air 2 iOS 10 and above
Apple iPad Mini 4 iOS 10 and above
Apple iPad Pro 9.7” iOS 10 and above
Apple iPad (2017) iOS 10 and above

Backup battery charging

The device contains an internal backup battery supplied in a semi-charged state. After the device is purchased,
we advise you to charge the device before the first use.

Charge the device completely before any scenario of long non-usage lasting over 3 months.

Installation of application

Search and install the application from the Application store on the tablet device.

First time connection – application to device

1. Switch on the device using power on-off button. Check the device name in device settings
(Menu > Settings > About).

2. Search and connect to the device with the name in Wi-Fi settings of the tablet device, using the default
password “12345678”.

3. Start the application on the tablet device. Entering the ECG device serial number is required when using
the application for the first time. The device serial number is written on a label on the back of the device.
It is then required to create a user account. When the application is launched, the recording screen with

the icon appears. The device name shows which device is connected.

It is important to connect the device to the tablet application before the first use or after a long time of
inactivity to synchronize the date and time between the device and the tablet application.

A connection failure may occur due to weak Wi-Fi signal due to interference or an obstacle. Reposition
both the device and the tablet to get higher signal strength and repeat the steps to connect the
application to the device.

The device enables to choose the Wi-Fi communication channel manually from Settings > Connection > Wi-Fi
Channel Selection. Default setting = Channel 1.

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 6 CONTROLS DESCRIPTION
This section of the manual explains the user interface of the device and the application. The buttons and
functionalities symbols appearing on the screen can be operated by touch actions.

6.1 MENU SCREEN – DEVICE

1. Recording screen

2. History screen

3. Rotate display 180

4. Settings

6.2 RECORDING SCREEN – DEVICE

1. ECG signal
2. Derived lead name (V1 – V6, I, II, III, aVR, aVL, aVF)
3. Rotate ECG signal layout (switch between 1, 3 or 12 leads with different sensitivity and speed)
4. Physical lead name (IEC or AHA, per device setting).
5. Top Row (See chapter 6.3)
6. Patient’s heart rate in real time
7. Menu button
8. Examination type – 12L ECG / 12L Rhythm
9. Record an ECG
10. Calibration pulse
11. Recording time
12. Cancel recording
13. Recording progress bar
14. Stop recording
15. Save ECG and repeat recording
16. Delete ECG and repeat recording
17. Save ECG

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 The operator is obliged to consult with the patient if they are fitted with pacemaker and add this
information into the patient’s profile. In an event of consistent pace pulse detection in a patient, every
pace pulse is represented as a red line in the top line of the waveform screen for indication only.

All recorded patient data will be lost in case the ECG recording is cancelled by the user.

ECG lead on a waveform screen can be shown as a square wave when no input signal is present or in
case of bad signal quality due to lead disconnection or improper patient preparation.

Pace pulse is detected only when all leads are connected to the Patient.

Top row of recording screen

1. Patient details
2. Number of ECG records pending
import to tablet application
3. Online transmission in progress
4. Battery status

6.3 HISTORY SCREEN – DEVICE

1. ECG
2. Back
3. Record another ECG for the
listed patient

Managing ECG history

The History screen lists ECGs that are recorded with the ECG system. Each ECG has a proper status. Use

to record ECG for the same patient.

Status Description

ECG recorded with no connection to the application and stored in the internal memory of the
Recorded
device

Sent ECG exported to the application (no confirmation that ECG was successfully imported)

ECG successfully imported to the application (confirmed that ECG was successfully
Delivered
imported)

Error Export of ECG was not successful

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6.4 SETTINGS – DEVICE
1. BTL Adaptive Workflow – Contains settings of a special feature called BTL Adaptive workflow. This
feature allows optimizing system workflow for user needs.
2. Connection – Contains settings and information related to Wi-Fi connection.
3. Recording – Contains settings related to ECG recording with the system.
4. History – Contains settings related to managing internal storage and displaying stored ECG records.
5. General – Contains general settings.
6. About – Contains information about the device.

6.5 LOGIN SCREEN – APPLICATION

It is required to enter the device serial number and accept the user agreement at the first application launch.

It is required to create a user account at the first login. The login screen is used to create a user using a valid
email ID and password during the first login.

The message “Failed to login, please check your username/password and try again” will appear on the
tablet screen when a wrong password is entered.

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6.6 RECORDING SCREEN – APPLICATION
Recording screen

1. Patient details

2. Heart rate

3. Leads system

4. Patients screen

5. Record – initiate ECG recording

6. Device connection status

7. Application settings

8. Speed and sensitivity settings

9. Filter settings

ECG recording, review and evaluation screens

1. Cancel recording

2. Recording progress
bar

3. Delete ECG and

repeat recording

4. Save ECG

5. Save ECG and repeat

recording

6. Print ECG report

7. Enter medical finding

8. Close evaluation

9. Report preview

An ECG lead in the waveform screen can show square wave when no signal is received from the
device due to disconnection or bad signal quality.

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6.7 PATIENTS CARD SCREEN – APPLICATION

1. List of patients

2. List of selected
patient recordings

3. Medical findings

Login setup or Email account configuration on a tablet is essential to email the ECG.

Disconnect the device and connect the tablet to a printer to print the ECG.

The application uses the Email account configured by the user on a tablet PC to email/backup
reports. The user is responsible to make sure only secure applications and accounts are configured
on the tablet device used for application installation.

6.8 SETTINGS – APPLICATION

1. List of settings

2. Detailed settings

List of settings:
 BTL Adaptive Workflow – Contains settings of a special feature called BTL Adaptive workflow. This
feature allows optimizing system workflow for user needs.
 General – Contains settings and information related to application and recording control.
 User – Contains settings related to managing application user and facility details.
 About – Contains information about the application.
 Backup&restore – Contains features to create and/or restore backup
 Purchase – Allows to purchase premium application features

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 7 ECG RECORDING WITH THE SYSTEM

7.1 POSITIONING OF ELECTRODES

Patient preparation – The ECG quality is particularly dependent on the contact between the electrode and
patient's skin.

To keep the contact as good as possible please follow the principles mentioned below:
• the skin should be warm and the patient relaxed
• cleanse the skin with alcohol before fastening the electrode
• apply sufficient layer of gel on the electrode

Unprepared skin may lead to a loose electrode placement resulting in distorted waveforms and failed
ECG examination.

Electrode Placement – Connect the 6L and 4L patient cable to the device. Connect the electrodes to patient’s
body and the device in the following sequence of lead placement.
• First, fasten the N (RL in AHA marking) electrode to patient’s right leg.
• Then, fasten the other limb electrodes R, L, F (RA, LA, LL in AHA marking).
• Finally, fasten the chest electrodes.

Limb Electrodes

IEC AHA
N black RL green Right leg (on the inside)
R red RA white Right arm (on the inside)
L yellow LA black Left arm (on the inside)
F green LL red Left leg (on the inside)

Chest Electrodes

IEC AHA
4th intercostal space
(between ribs 4 and 5) to
C1 red V1 red the right of the sternum
4th intercostal space
(between ribs 4 and 5) to
C2 yellow V2 yellow the left of the sternum
In the middle, between
C3 green V3 green leads C2 and C4
5th intercostal space
(between ribs 5 and 6) in
C4 brown V4 blue the mid-clavicular line
5th intercostal space (at
the same level as C4) on
the left anterior axillary
C5 black V5 orange line
5th intercostal space (at
the same level as C5) on
C6 violet V6 violet the left midaxillary line

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7.2 CONNECTING THE APPLICATION TO THE DEVICE
Follow the sequence in chapter 5 to connect the application to the device for the first time. The application
connects to the device automatically on start-up, with WiFi enabled in tablet. If multiple devices are available,
choose and connect to the required device from WiFi device list in the Tablet settings.

Note: The device can also work in an offline mode (no connection between the device and the application).
Recorded ECG is stored to device internal memory. Such ECG can be managed on device history screen. All
these ECG records are stored in status “recorded” in order to easily recognise which ECG is to be imported to the
application manually once connection is established.

7.3 ENTER PATIENT INFORMATION AND START RECORDING

NOTE: Some of the features mentioned in chapters 7.3 – 7.5 are available only after a purchase. The purchase is
available in application Settings>Purchase.

1. Access patients screen using icon in the application.

2. Create a new patient with button or choose an existing patient from the list on the screen.

3. Start ECG recording for selected patient using on the patients screen of the application. Observe
patient details on the recording screen of the application and on the device display.

4. Check ECG signal quality on the device display

Lead colour Leads quality status

Grey Connection is good enough for recording

Orange Improve lead connection with skin

Red Lead is disconnected

Note: ECG recording can be started without entering patient details using . Patient’s name is automatically
generated as YYYY.MM.DD HH:MM:SS Unknown (tablet device date and time). This generated name can be
changed on the patients screen to a real name after the recording.

Note: If ECG recording is started from the device without entering patient details in a mode when the device is not
connected to the application (offline mode), general name format is displayed YYYY.MM.DD HH:MM:SS
Devicename. Such ECG can be imported manually (follow the sequence in chapter 7.6). The same can be edited
later in the application and linked to an existing patient in the patients list.

Use on the device history screen to record ECG for prevously recorded ECG in online mode. At that
moment, the ECG record has the same name. Such ECG can be imported manually (follow the sequence in
chapter 7.6).

The tag “NOT OPERABLE” is shown on the waveform screen on the tablet if the ECG signal exceeds
the specified signal range. Review and correct patient’s skin preparation.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 24 OF 40

7.4 ECG RECORDING AND REVIEW

1. When you find the ECG signal ready for recording, press to initate recording. ECG recording can
be started from the device or application.

Note: ECG recording started from the application cannot be cancelled from the device.

Note: When the device history has reached the maximum count of 30 ECGs, the system will
automatically delete the oldest "delivered" ECG on the history screen. If there are no records with a
"delivered" state in history, a warning will pop up on the device display to prompt you to make storage
space by manually deleting records on the history screen. This warning pop-up can be disabled/enabled
in Menu>Settings>Warn before overwriting undelivered records.

2. Observe progress of ECG recording in the progress bar icon on the device and in the application.

3. Check the ECG preview in the application and save the ECG by pressing .

4. The user also has an option to press to save the current ECG and immediately record one more
ECG for the same patient.

5. Button deletes a recorded ECG, but enables recording a new ECG for the same patient again
immediately.

6. Evaluation screen enables you to type medical findings, preview and to print an ECG report

7. Use to close the evaluation screen

Saved ECGs can be seen on the patient screen in the application.

Recording during defibrillation

The equipment is protected against any damage of cardiac defibrillator discharge to ensure recovery as required
by the test standards. As for the test standards, the recovery of ECG trace to return does not exceed 5 seconds
after defibrillation.

The signal input from the patient to the acquisition module is defibrillation proof. It is not necessary to remove the
ECG electrodes from the device prior to defibrillation in the case of using non-polarizing electrodes.

Refer to the List of accessories for approved electrode details.

7.5 PRINTING AND SHARING ECG

Select a patient and his ECG to be shared or printed on the patient screen of the application.

 Press to print using a wireless printer connected to the tablet.

 Press to share the ECG.

Note: The ECG can be shared either as a PDF report or as an XML file. The share format can be changed in the
application settings.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 25 OF 40

7.6 MANAGING ECG HISTORY
Importing ECG from the application

 Press on the patient screen to import ECG from the device memory to the application.
 Application lists ECG status as ’recorded’, ’sent’ and ’error’
 Select an ECG to be imported
Note: Select ’Display delivered’ to view ECGs with the status ’delivered’.

Managing ECG

When you select a patient and an ECG on the patients screen in the application, by choosing the
following actions are possible:
1. Hide/Unhide an ECG using ‘Hide examination’. Hidden ECGs can be seen after enabling this in the
application settings.

2. Assign an examination to another patient in the patient list.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 26 OF 40

 8 FILTERS
This chapter describes the filters, their setting and the influence on the ECG signal waveform. The present
configurations are described first and the individual types of filters are defined at the end of the chapter.

The setting of the filters for printing or display has no influence on the shape of the averaged complex or on the
diagnostics results.

We strongly recommend becoming well-acquainted with this chapter of the User’s Manual. You will avoid many
possible, subsequent complications and misunderstandings that could result from using wrong filters settings.

8.1 PREDEFINED FILTERS

The program includes predefined filters to help you with the setting of the ECG signal filtering. Get acquainted
with their setting, description and properties before you start working with the program.

Default filter

This setting contains a set of filters, which gives the best results for most examinations.

Exceptions:

 Patients with a pacemaker implanted. If you want to keep the shape of the pulses obtained from the
pacemaker, switch to the “User Filter” and switch off the “Myo Filter”.
 ECGs taken in an extremely disturbing environment or while the patient is moving. In such an event,
switch to the “User Filter” and set another combination.

This setting consists of the following filters:

 Mains: 50 Hz Adaptive
 Drift: 0.25 Hz
 Myo: 90 Hz Adaptive

No Filter

This setting does not include any filter and the transferred band is, in this case, 0.05 Hz - 170 Hz.

Strict Filter

This setting includes a set of filters that suppress the interference in the ECG signal the most. However, it can
also suppress the most useful parts of the ECG signal that could be important for further diagnostics. This filter
may, for example, also cause slight widening of the QRS complex, reduction of its amplitude and distortion of the
ST segment and T wave. Before each ECG recording, carefully consider using this filter.

This setting consists of the following filters:

 Mains: 50/60 Hz Adaptive

 Drift: 0.6 Hz (0.3 s)
 Myo: 25 Hz

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 27 OF 40

8.2 USER FILTERS
This option will enable you to create your own combination of filters you need for the ECG signal recording. The
options include the following:

Mains

This interference comes from the electric mains and appears across the entire ECG signal. It manifests itself as
very fast oscillation.

1. No Filter

No filter is used here to suppress the mains interference. The entire signal may be disturbed by
interference from the mains frequencies even if the ECG runs on the batteries.

2. 50/60 Adaptive

This filter suppresses the mains interference at frequencies of 50 and 60 Hz. The filter
automatically adapts to the exact frequency of the mains, as well as to the current amplitude of
the noise. Unlike the “notch” filters, this filter does not distort the QRS complexes. We
recommend having this filter switched on permanently; otherwise the entire signal may be
disturbed by the mains frequency.

Drift

These filters suppress all slow changes in the ECG signal and are primarily intended for the control of the zero-
baseline drift such as the one appearing as a result of the patient’s breathing.

1. 0.05 Hz

This filter suppresses the frequencies in the ECG signal that are lower than 0.05 Hz. This corresponds to
a signal repeating with a period of 3.2 seconds. This filter does not distort the ECG signal being
recorded, but in case of a baseline jump (e.g. due to static charge) the signal returns to zero very slowly,
taking up to 12 seconds.

2. 0.25 Hz

This filter suppresses the frequencies in the ECG signal that are lower than 0.25 Hz. In case of a
baseline jump (e.g. due to static charge) the signal returns to zero, taking up to 4 seconds.

3. 0.6 Hz

This filter suppresses the frequencies in the ECG signal that are lower than 0.6 Hz. This frequency
corresponds to a signal repeating with a period of 0.3 seconds. This filter can suppress the zero baseline
drift the most, but it may also distort the useful signal containing slow changes (typically the ST stage
and the amplitudes of peaked T waves of the ECG signal). Set this filter only if the zero-baseline drift is
unacceptable and cannot be compensated for by any of the above-mentioned filters. It is not
recommended as the default setting for the recording of all ECG signals.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 28 OF 40

Myo

These filters serve to suppress the interference originating in the patient’s muscular activity and other
electromagnetic interference stretching to the spectrum of the ECG signal. This interference is apparent in the
ECG signal as random oscillations in the entire record or a part of it.

This filter category also filters out pacemaker pulses. If used, these pulses may be strongly reduced or
even eliminated. Low-energy pulses, typical for bipolar stimulation, may be eliminated as well.

1. 90 Hz Adaptive

This filter is recommended as default for most ECGs. The filter smoothly retunes its resulting cut-off
frequency so as to permanently preserve the useful signal components. The unprocessed signal is
monitored by the curvature analyser. The output of the analyser smoothly sets the output cut-off
frequency of the filter. In the area of rapid changes (typically QRS), the frequencies are transferred at up
to 90 Hz, whereas in the slow areas (for example the T-P segment) the cut-off frequency drops. In
extreme cases, it can go as low as 20 Hz. As a result, the distortion of the QRS complex is minimized
and the readability of the P waves is maximized.

2. 35 Hz

This filter, with a cut-off frequency of 35 Hz, suppresses all frequency components of the ECG signal
higher than 35 Hz. It may reduce the amplitude of QRS, especially in children. It also reduces the
amplitude of pacemaker pulses. If, for any reason, you cannot or do not want to use the 90 Hz Adaptive
filter, select this option.

3. 25 Hz

This filter suppresses all frequencies higher than 25 Hz. This setting may influence the recorded ECG,
especially in the area of the QRS complex. It may cause slight widening of the QRS complex and
reduction of its amplitude. It also reduces the amplitude of pacemaker pulses. It is not recommended to
use this filter as the default setting for all examinations.

4. 20 Hz

This filter suppresses all frequencies higher than 20 Hz. The filter should be used only in extreme cases,
such as when the muscular interference is unacceptable and cannot be compensated for in any other
way. Please note that this filter may deform (round and widen) any rapid changes in the ECG signal
(especially the peaks of the QRS complex), because the most significant frequency components of the
QRS complexes lie in the band up to 35 Hz. It also reduces the amplitude of pacemaker pulses. Always
check the shape of QRS on the averaged beat.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 29 OF 40

9 TROUBLESHOOTING
Please contact the BTL authorized service department for further assistance, in-case the following
troubleshooting solutions do not solve your problem.

Trouble in connecting the application to the device:

→ The application is not able to connect to the device, even when in the device signal range. →
Interference from an external device. Move away from interference and try reconnecting.

→ The application is out of the device signal range. → Move the tablet closer to the device signal
range and try reconnecting.

Indication of Signal Strength in the tablet application.

→ It is not possible to see the device name in the tablet settings - WiFi device list. → The device is
switched off or in the offline mode. Switch on the device or disable ‘Work offline’ in device settings >
connection.

→ The device is listed in the tablet settings - WiFi device list, but it is unable to connect. →
Identify the WiFi address of the connected tablet application. The details can be found in device settings
> connection. Disconnect and try reconnecting.

The device is not charging:

→ The device is not charging with a power adaptor connected. → Broken power adaptor or loose
connection. Check the LED glow on the adaptor. If it is fine, clean the device area before connecting. If
any foreign particle is observed, reconnect the adaptor to the device and check for charging indication.

→ The device is connected to the power adaptor, there is a damaged battery indication on the
device display. → Broken battery, contact the BTL Authorized service for further assistance.

Factory reset:

→ The device is hanged and doesn’t switch off→ Broken device, contact the BTL Authorized service
for further assistance.

→ The device doesn’t respond to operator actions in a normal-use scenario. → Re-initialize the
system by Factory reset in settings > Device settings > Factory reset.

Backup all data to the tablet application before a factory reset of the device.

Backup all data to cloud in the tablet application before any re-installation of application.

ECG signal quality:

→ Noise observed in ECG signal in the device and on the application display → improper skin
preparation or loose connections to the patient or damaged patient cable; check skin preparation,
connection and cable, reconnect / replace damaged lead wires and recheck signal quality. In case of
further noise in signal, change filter settings and recheck ECG signal quality.

Device overheat:

→ Overheat shutdown after short usage (<1 hour of usage under recommended operating
conditions). → Allow the device to cool in operating condition for 30 minutes to 1 hour. If the problem
persists and repeats, contact the BTL Authorized service for further assistance.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 30 OF 40

10 MAINTENANCE

Before any maintenance of the device, please switch the device off and disconnect it from the power
supply! Never dismantle the device during a cleaning procedure!

Recommended intervals for inspection of the device are 24 months after installation and subsequently each
12 months. The intervals may differ according to the local regulations. The inspection shall be performed
according to the procedure authorized by BTL.

The ECG system does not contain any components that can be repaired or serviced by the user or any
unauthorized service personnel. Any attempt to do so can damage the system and hamper its
functioning. Please contact the authorized BTL service department for service-related needs.

Device cleaning

Keep the device clean. Use lint free soft cloth slightly moistened (drip free) with water or with 2% detergent
solution or other mild cleaning agents.

Use cleaning agents recommended for monitor screens. Use a slightly moistened (drip free) lint free soft cloth for
cleaning of touch panel.

Battery maintenance

Fully charge the battery before each use. It takes approximately 8 (eight) hours to fully charge the battery from
zero capacity. Fully charge the battery in the event of any long storage without use.

Please check the warning list on maximum charge cycle completion. Contact the BTL authorized service for
further assistance.

Maintenance of patient cables and re-usable electrodes

Periodically inspect the patient cables and electrodes. Do not use any damaged parts. Contact BTL authorized
service department for replacement of damaged leads.

It is recommended to clean the re-usable electrodes after examination of each patient. For cleaning,
use agents which were approved by your local competent health office and are suitable for cleaning
and/or disinfection of the ECG accessories.

Use bridges provided on cables for proper routing and to avoid cables getting entangled.

Clean the patient cables regularly before use using a soft cloth slightly moistened with water or with 2% detergent
solution or other mild cleaning agents.

Usage of harsh cleaning agents with chemicals like alcohols, ammonium chloride, sodium hypochlorite
or any abrasive material might lead to damage of the device, cables and electrode parts.

Drip free cloth is recommended to avoid cleaning agent entry and damage to the device. Ensure dry
patient cable holder pocket before reuse.

Transport and storage

It is recommended to keep the equipment packaging for safe transportation.
Store the device indoors only, in a dust-free environment.

After bringing the equipment from a cold environment to the operating environment, do not plug it in the
mains until the temperatures of the equipment become equal to the operating temperature.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 31 OF 40

11 ACCESSORIES
The ECG system is not designed for use with other medical devices or accessories except for those stated
specifically in this manual.

The following is a list of accessories that can be supplied with the equipment:

 BTL Flexi 12 ECG patient cable chest 6-lead with banana plug

 BTL Flexi 12 ECG patient cable limb 4-lead with banana plug

 BTL Flexi 12 ECG patient cable chest 6-lead with pinch connector

 BTL Flexi 12 ECG patient cable limb 4-lead with pinch connector

 Charger for the BTL Flexi 12 ECG acquisition device

 Wi-Fi dongle

 Docking station

 Belt strap

 Belt strap plate for connection between the BTL Flexi 12 ECG and belt strap

 Extremity AgCl electrodes

 Chest AgCl electrodes

 Universal self-adhesive ECG electrodes (disposable, for pinch connector)

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 32 OF 40

12 TECHNICAL PARAMETERS

Device name BTL Flexi 12 ECG

General characteristics device
Display dimension and resolution 2.8”, 240 x 320 dots
Overall dimension (mm) 82 x 87 x 25
Weight 150 g
Keyboard Touch panel on device
External printer Wireless printer supported by tablet.
Print speed (mm/sec) 5; 10; 12.5; 25; 50
Sensitivity (mm/mV) 2.5; 5; 10; 20
Print layout 2x6+1R; 4x3+1R; 1x12+0R
12 Leads (I, II, III, aVR, aVL, aVF,
Number of leads
V1, V2, V3, V4, V5, V6)
1; 3; 12 in device
Number of displayed leads
12 in tablet application.
R, L, F, N, C1, C2, C3, C4, C5, C6 or
Electrode set
RA, LA, LL, RL, V1, V2, V3, V4, V5, V6
Length of record (device)
Automat 10 s; 12 s; 15 s; 20 s
Maximally 30 ECG on device
Storage
Maximally 6000 ECG on application.
Filters
Mains filter (Hz) 50; 60
Drift (Hz) 0.05; 0.25, 0.6
Myo (Hz) 20; 25; 35; 90
Detects pace pulses of
Detection of pacemaker Pulse width: 0.1 ms – 2 ms
Pulse amplitude: 2 mV – 250 mV
Operating conditions
Temperature 10 °C to +40 °C
Relative humidity 30 % to 75 %, Non-condensing
Atmospheric pressure 700 hPa to 1060 hPa
Transport and storage conditions
Temperature -10 °C to +55 °C
Relative humidity 10 % to 85 %, Non-condensing
Atmospheric pressure 650 hPa to 1100 hPa
Power supply
Mains voltage 100–240 V ~
Frequency 50–60 Hz
Protection class Class I
Comply with the IPx2 requirement as per standard
Ingress condition
IEC 60529.
Battery Li-Ion battery, 3200 mAh capacity, 3.6 V
Applied part Type CF
Amplitude resolution 1 μV ±1 % per LSB @ 500 SPS
AC differential: ±5 mV
Dynamic range
DC offset: ±300 mV
Frequency range 0.05 Hz to 170 Hz
>90 dB (filter off).
Common mode rejection
>100 dB (filter 50/60 Hz on)
WiFi frequency 2.4 GHz
Communication channel 1 (2412 MHz) to 11 (2462 MHz)
Modulation DSSS / CCK / OFDM
Effective radiated power 7.92 dBm or 6.198 mW, measured at 11 Mbps

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 33 OF 40

12.1 ELECTROMAGNETIC COMPATIBILITY (EMC)
BTL Flexi 12 ECG complies with IEC 60601-1-2 requirements for “Electromagnetic Compatibility” (EMC). The
ECG system, however, may be affected when operated near another medical device or equipment generating
high levels of magnetic and electrical fields, resulting in electromagnetic interference. The mutual interference of
electromagnetic magnetic fields hampers the effective functioning of the ECG system. The electromagnetic
interference is displayed as artefacts on ECG waveforms or distorted data acquisition during ECG examination.

Follow the listed precautionary measures if electromagnetic interference is experienced during ECG examination:
Reposition the device and maintain a safe distance from another device to reduce the mutual interference levels.
Temporarily power off devices generating high levels of electromagnetic fields.

Guidance and manufacturer’s declaration – Electromagnetic Emissions

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

Emissions test Compliance Electromagnetic environment - guidance

RF emissions The device uses RF energy only for its internal function.
Group 1 Therefore, its RF emissions are very low and not likely to cause
CISPR 11 any interference with nearby electronic equipment.

RF emissions
Class B
CISPR 11

Harmonic Emission The device is suitable for use in all establishments, including
Class A domestic establishments and those directly connected to the
IEC 61000-3-2 public low-voltage power supply network that supplies buildings
used for domestic purposes.
Voltage Fluctuations /
Flicker Emission Complies
IEC 61000-3-3

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 34 OF 40

 Recommended separation distances between portable and mobile RF communications equipment and the
device

The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the device as
recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximum output
power of transmitter m

W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

d  1.2 P d  1.2 P d  2.3 P

3V 3V/m 3V/m

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 35 OF 40

 Guidance and manufacturer’s declaration – Electromagnetic Immunity

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

Electromagnetic
Immunity test EN 60601 test level Compliance level
environment – guidance

Electrostatic Floors should be wood, concrete or

± 6kV contact ± 6kV contact ceramic tile. If floors are covered
discharge (ESD)
± 8kV air ± 8kV air with synthetic material, the relative
EN 61000-4-2 humidity should be at least 30 %.

Electrical fast Mains power quality should be that

transient/burst ± 2 kV for power supply ± 2 kV for power supply
of a typical commercial or hospital
lines lines
EN 61000-4-4 environment.

Surge ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that
of a typical commercial or hospital
EN 61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth environment.

< 5 % UT < 5 % UT
(> 95 % dip in UT) (> 95 % dip in UT)
for 0,5 cycle for 0,5 cycle

Voltage dips, Mains power quality should be that

40 % UT 40 % UT
short interruptions of a typical commercial or hospital
(60 % dip in UT) (60 % dip in UT)
and voltage environment. If the user of the
for 5 cycles for 5 cycles
variations on device requires continued operation
power supply during power mains interruptions, it
input lines is recommended that the device be
70 % UT 70 % UT
powered from an uninterruptible
EN 61000-4-11 (30 % dip in UT) (30 % dip in UT)
power supply or a battery.
for 25 cycles for 25 cycles

< 5 % UT < 5 % UT
(> 95 % dip in UT) for 5 s (> 95 % dip in UT) for 5 s

Power frequency Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic of
magnetic field 3 A/m 3 A/m
a typical location in a typical
EN 61000-4-8 commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 36 OF 40

 Guidance and manufacturer’s declaration – Electromagnetic Immunity

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

Electromagnetic
Immunity test EN 60601 test level Compliance level
environment – guidance

Portable and mobile RF communications

equipment should be used no closer to any
part of the device, including cables, than the
Conducted RF 3 Vrms recommended separation distance calculated
3V
EN 61000-4-6 150 kHz to 80 MHz from the equation applicable to the frequency
of the transmitter.

Recommended separation distance

d  1,2 P

d  1,2 P 80 MHz to 800 MHz

d  2,3 P 800 MHz to 2,5 GHz

where P is the maximum output power rating

of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
Radiated RF 3 V/m (m).
3 V/m
EN 61000-4-3 80 MHz to 2,5 GHz Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey,
should be less than the compliance level in
b
each frequency range.

Interference may occur in the vicinity of the

equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the device.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 37 OF 40

13 MANUFACTURER

BTL Industries Ltd.

161 Cleveland Way
Stevenage
Hertfordshire
SG1 6BU
United Kingdom

E-mail: [email protected]

Website: http://www.btlnet.com

For service, please contact the service department at [email protected].

th
Date of last revision: 5 October 2017

ID: 076-80MANEN02101

© All rights reserved. No part of this manual may be reproduced, saved in a research centre or transferred by any
means incl. electronic, mechanic, photographic or other records without previous approval from BTL Industries
Limited.

BTL Industries Limited operates a policy of continuous development. Therefore, it reserves the right to make
changes and improvements to the Product described in this manual without prior notice.

The content of this document is provided "as is". Except as required by applicable law, no warranties of any kind,
either expressed or implied, are made in relation to the accuracy, reliability or contents of this document. BTL
Industries Limited reserves the right to revise this document or withdraw it at any time without prior notice.

BTL FLEXI 12 ECG – USER´S MANUAL | PAGE 38 OF 40

076-80MANEN02101