Vitalograph BT12 ECG Installation guide

ECG
BT12 ECG
User Training Manual
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Vitalograph Ltd. UK
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
www.vitalograph.co.uk
Vitalograph Ltd. International
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
www.vitalograph.eu
Vitalograph GmbH
Rellinger Straße 64a,
D-20257 Hamburg,
Germany
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
www.vitalograph.de
Vitalograph Inc.
13310 West 99th Street,
Lenexa, Kansas, 66215,
USA
Toll Free: 800 255 6626
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
www.vitalograph.com
Vitalograph (Ireland) Ltd.
Gort Road Business Park,
Ennis, Co. Clare, V95 HFT4,
Ireland
Tel: [phone]
Fax: : [phone]
E-mail: [e-mail]
www.vitalograph.ie
Vitalograph Ltd. Hong Kong /China
Unit 2001, Floor 20, Block A,
New Trade Plaza, 6 On Ping Street,
Shatin
Hong Kong
Phone: [phone]
Fax: : [phone]
E-mail: [e-mail]
www.vitalograph.cn
© Copyright Vitalograph 2017
Current Edition (Issue 3)
Cat. No. 07657
is a registered trademark
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Table of Contents
DESCRIPTION OF THE VITALOGRAPH BT12 ECG1.
Indications for use1.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS2.
MAIN COMPONENTS OF THE VITALOGRAPH BT12 ECG3.
FEATURES OF THE VITALOGRAPH BT12 ECG4.
GETTING THE VITALOGRAPH ECG READY FOR USE
Unpack device1.
Power management2.
Clip3.
Electrodes and electrode cable4.
Electrode position5.
Functional Check6.
5.
OPERATING THE VITALOGRAPH BT12 ECG
Pairing the ECG device1.
Preparing the ECG recording2.
Switching the ECG measuring unit on/off3.
Electrode contact4.
Heart rate monitoring5.
ECG data transmission6.
Displays and signals7.
6.
CLEANING INSTRUCTIONS
Maintenance1.
Disposal2.
Cleaning and disinfection of the surface of the device3.
Cleaning and disinfecting the electrode cable4.
Electrodes5.
7.
FAULT FINDING GUIDE8.
CUSTOMER SERVICE9.
CONSUMABLES AND ACCESSORIES10.
EXPLANATION OF SYMBOLS11.
TECHNICAL SPECIFICATIONS12.
CE NOTICE13.
FDA NOTICE14.
DECLARATION OF CONFORMITY15.
GUARANTEE16.
APPENDIX17.
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1. DESCRIPTION OF THE VITALOGRAPH BT12 ECG
The BT12 ECG measuring unit is an active medical product and in connection with a receiving unit serves as a mains-
independent, wireless ECG device which can be worn on the body for the following purposes:
Measurement of an ECG
Measurement of the heart rate with optical and acoustical signals when preset values are exceeded or fallen short
of
To supports a diagnosis from a physician
Documentation of ECGs
The ECG measuring unit can be used in the clinical area and in a doctor’s practice. The subject or relative – after being
instructed accordingly – can operate the device for patient monitoring at home. The ECG measuring unit is not suitable
for intracardial use.
Figure 1: BT12 ECG Measuring Unit
The measured ECG is transferred via a Bluetooth interface to an external receiver unit such as a PC running monitor
software. Here, the data may be displayed specific to a subject, saved, commented, printed out and revised by expert
personnel.
The main components for the Vitalograph BT12 ECG are shown in Figure 2.
Warning: No modification of this equipment is allowed. Any unauthorised changes to the ECG device may
compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will
no longer be supported.
1.1 Indications for use
The BT12, hereafter referred to as the “BT Device”, is a battery powered device capable of acquiring and transmitting a
standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and
diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by
the monitoring device operated by medical professionals.
The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring
device, such as a PC or hand-held device for display, review, printing, saving and post event processing by medical
professionals. Use of the BT device is not restricted to the adult population, but is also intended for infants weighing less
than 10Kg(22lbs).
Measurements taken by the BT device are only significant if considered in connection with other clinical findings. No
therapy or drugs can be administered based solely on ECG data derived from the BT device. The BT device is not
intended for monitoring critical patients and is not intended for intracardial use
Federal law restricts this device to sale by or on the order of a physician.
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2. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS
Read this User Training Manual carefully, it is a component of the device and must be available at all times. Only use the
device for the described purpose (see Section 1.1). Please also observe the User Training Manual of the PC software
used with the measuring unit PN 07402.
2.1 General
The ECG measuring unit may only be used by persons who can guarantee that it will be used properly based on
their training/education or knowledge e.g. instruction.
If original accessories are not used, this could result in function failures and bio-compatibility cannot be assured.
Observe that in such cases, any warranty or liability claims are void when neither the accessories recommended
in the User Training Manual nor the original replacement parts are used.
The ECG measuring unit is not suitable for use in rescue helicopters or ambulances.
Observe section 5 “CLEANING AND DISINFECTION” to avoid contamination.
Only allow repair work be done by the manufacturer or other expert personnel.
Before each use, visually inspect the device, the electrode cables and the adhesive electrodes. If there is any
externally visible damage or if the self-test fails the device may no longer be used.
The ambient conditions specified in the technical data are to be complied with.
The ECG measuring unit may not be submerged in liquids or have liquids poured on it, be intentionally sprayed
or be exposed to rain.
The ECG measuring unit may only be opened by authorized expert personnel. If the device is opened without
permission, the warranty is void.
The manufacturer is not liable for the function of the ECG measuring unit if the device is improperly maintained
by the owner/operator or if it is treated in a way which doesn’t correspond with its proper use in accordance with
this user manual.
The signals output by the measuring unit do not meet the alarm standard for medical electrical devices, DIN EN
60601-1-8.
To guarantee patient safety, the receiver unit and peripheral devices are to be operated outside of the patient’s
immediate surroundings, i.e. with a minimum distance of 1.5 m to the patient.
All parts of the measuring unit, including accessories, which come into contact with the patient during intended
use, meet the requirements of the applicable standards with regard to bio-compatibility.
2.2 Operating the device
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The ECG measuring unit, especially the electrodes and electrode cables, may only come into contact with
healthy patient skin.
Wear the ECG measuring unit on a piece of clothing or carry it in its pouch (accessory).
While the ECG is recording, don’t make any changes to the electrodes or the device as this may result in faulty
measurements.
The ECG measuring unit is a defibrillation-proof application part of type BF. The device is not suitable for direct
leads to the heart. When using a defibrillator, the ECG electrodes and the defibrillator must not come into contact.
Note: When using a defibrillator, make sure that no one has a conducting connection to the patient. Burns or
other injuries could result.
It is not possible to operate High Frequency devices, e.g. surgical devices, in combination with the ECG
measuring device.
When monitoring critical patients, an alternative ECG system should be kept readily available in the event of a
device fault or failure.
Avoid tensile loads on electrode cables.
Only use bio-compatible and CE-approved ECG electrodes with the ECG measuring unit.
Always observe the user instructions for the used electrodes.
Magnetic and electric fields can influence the function of the device. Keep the recommended separation distance
between the ECG measuring unit and devices which emit High Frequency radiation (e.g. cell or mobile phones)
to ensure correct operation (see Section 12 “Technical Specifications“).
Observe that when the measuring unit is switched on, the electromagnetic radiation it emits can influence other
electric devices around it. Keep the recommended separation distance between the ECG measuring unit and
other devices to ensure there in no interference (see Section 12 “Technical Specifications“).
The ECG measuring unit may not be operated in potentially explosive atmospheres.
Check the signal limit settings before every monitoring phase.
When using the BT12 during a stress ECG, it is required that the patient be under constant observation.
The ECG measuring unit may not be used without supervision on children under the age of 3 or mentally
confused patients. There is a risk that the electrodes could be aspirated.
Wireless transmission errors could occur if heat therapy devices are operated in the immediate vicinity.
If the patient has a cardiac pacemaker, there could be errors in the heart rate calculations.
In rare cases the measuring unit may heat up in rare cases due to a short circuit in the batteries. Turn off the
ECG measuring unit immediately and remove the batteries. Stop using the device and have it repaired before
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using it again.
Make sure that the Bluetooth monitor to which the measured data is transmitted is invisible to other Bluetooth
end devices. Otherwise, there could be errors in the data transmission.
BT12 operate safely and effectively in an environment where BT devices and WLAN devices coexist. But some
restrictions have to be considered. We recommend using the BT12 device together with a maximum of two other
BT ECG devices within the range of each BT ECG device. Furthermore, any WLAN sender or receiver (e.g.
WLAN USB dongles for PCs) should be placed more than 1 meter away from the BT12 and the BT receiver (BT
USB dongle for PCs) respectively. Otherwise, BT12 will lose data packets. The user is responsible for ensuring
that data transmission is not corrupted by too many wireless senders or receivers in the vicinity.
Refer to the appendix at the end of this User Training Manual for a troubleshooting guide on pairing the
Vitalograph ECG.
3. MAIN COMPONENTS OF THE VITALOGRAPH BT12 ECG
Figure 2
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A ECG device
B Electrode cable
C Electrodes
4. FEATURES OF THE VITALOGRAPH BT12 ECG
The Vitalograph BT12 device features include:
Capable of acquiring and transmitting standard 12 lead ECG
Battery powered
Small, portable design with integrated clip to allow for attachment to clothes/belt
Heart rate monitoring with results displayed on the integrated LCD
Wireless connectivity to monitoring software to allow display, review, printing, saving and post event processing of
data
5. GETTING THE VITALOGRAPH BT12 ECG READY FOR USE
5.1 Unpack device
Remove all components of the Vitalograph BT12 ECG device carefully from the packaging. Check them against the
contents list to ensure that they are all present and check them for damage. If any are missing or damaged do not use
the device. Contact the distributor or the manufacturer directly for replacement parts.
ATTENTION : Packaging material can pose a suffocation danger. Keep it away from children and dispose of it
properly.
5.2 Power Management
The ECG measuring unit requires two AA alkaline batteries or two AA NiMH rechargeable batteries for operation. The
operating time depends on the quality of the selected batteries. With the BT12, runtimes between 9 and 13 hours can be
achieved.
Power source Manufacturer Device runtime Device runtime BT12
Alkaline LR6 AA TDK, Duracell 15 hours 9 hours
Varta photo rechargeable
NiMH AA batteries
Varta 20 hours 13 hours
To insert the batteries, open the battery compartment cover and insert the batteries according to the shown polarity inside
the battery compartment. Close the battery compartment cover.
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Figure 3: Opened battery compartment with inserted batteries
The battery status for the activated device is visible on the battery icon at the bottom left of the screen. It is recommended
to change the batteries when the display shows no bars and the battery icon flashes. In measuring mode, the ECG
measuring unit is designed for between 9 to 13 hours of operation, depending on the type of batteries used.
ATTENTION: Dispose of used batteries according to the valid regulations of your country.
5.3 Clip
The device can be worn on the patient’s clothing with the clip. To fasten the device to clothing, push the clip in a loop of
clothing or on a belt.
Figure 4: ECG measuring unit with clip
5.4 Electrodes and electrode cable
Make sure the ECG adhesive electrodes are applied carefully. A disturbance-free ECG is only guaranteed if the
electrodes are correctly positioned with good skin contact.
Adhesive electrodes are intended for one-time use only
Always observe the user instructions for the used electrodes
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Shave off any excess hair which could prevent good electrode contact
The application positions (see section 5.5) must be clean and dry
Remove the foil from the adhesive electrodes
The electrodes may only be applied to healthy skin
Do not use any electrodes past their expiration date or if the gel is dried out
Make sure that electrodes are exchanged according to manufacturer specifications
Press the electrodes firmly onto the patient’s skin at the corresponding places, depending on the desired lead
For an optimal measured result, it is recommended that the original ECG cable which was included in delivery be used. If
a cable is used other than the original ECG cable included in delivery, there can be no guarantee that it will function
correctly.
ATTENTION : The electrode cable can pose a strangulation danger, always attach the device to clothing/belt or
pouch as instructed and do not use without supervision on children under the age of 3 or mentally confused
patients.
ATTENTION : The electrodes can pose a suffication/aspiration danger, do not use without supervision on
children under the age of 3 or mentally confused patients.
5.5 Electrode position
The following table provides an overview of the electrodes and neutral electrodes, their positions, as well as their ID and
color code in accordance with DIN EN 60601-2-27 and ANSI/AAMI EC11.
System CODE 1 electrodes CODE 2 electrodes Position on the surface of
the body
ID Color Code ID Color Code
Extremities R Red RA White
Right Shoulder
L Yellow LA Black
Left Shoulder
F Green LL Red
Left Hip
N Black RL Green
Right Hip (neutral electrode)
Chest wall acc. to Wilson C1 White/Red V1 Brown/Red
In the IV intercostal space
on the right sternal border
C2 White/Yellow V2 Brown/Yellow
In the IV intercostal space
on the left sternal border
C3 White/Green V3 Brown/Green
On the 5th rib between C2
and C4
C4 White/Brown V4 Brown/Blue
In the V intercostals space
on the left midclavicular line
C5 White/Black V5 Brown/Orange
On the front left axial line at
the level of C4
C6 White/Purple V6 Brown/Purple
On the left midaxillary line at
the level of C4
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Figure 5: Positions of the chest wall leads
5.6 Functional Check
Every time the ECG measuring unit is switched on, it carries out an integrated self-test. Error conditions in the electronics
or program run are indicated on the display with “Err” and an error code.
Figure 6: Display of error codes
Visually inspect the ECG measuring unit before every use. If any external damage to the device or the electrode cables is
noted or if the integrated self-test fails, do not continue to use it. Contact the distributor or manufacturer to have the
device repaired or replaced, please refer to the contact information at the start of this manual.
6. OPERATING THE VITALOGRAPH BT12 ECG
6.1 Pairing the ECG device
The first time a connection is established with a monitor such as a PC running appropriate software, the ECG measuring
unit is paired to this monitor. If the Bluetooth driver requests a PIN number during this pairing operation, enter “1111”.
To avoid data transmission errors and to deny access to unauthorized parties, the ECG measuring unit is no longer
visible to other Bluetooth devices after this pairing. This pairing can be broken by following the instructions below -
1. Turn on the device by pressing the power button.
2. Once the device is on press and hold the power button for 20 seconds.
3. The device will emit beeps during this process, 1 x long beep after 3 seconds and 2 x short beeps after 20
seconds and then it switches off. After switching on again the ECG measuring unit is visible to other Bluetooth
devices and may be paired to a new monitor.
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Refer to section 17. Appendix for a complete troubleshooting guide on pairing the ECG device.
6.2 Preparing the ECG recording
Examine the ECG measuring unit and the electrode cable for externally visible damage. If any damage is noted, have the
unit repaired or replaced before using it. If the ECG cable for the BT12 shows any signs of damage, replace it before
using it.
Before using the ECG measuring unit, make sure that the expiration date of the adhesive electrodes you are using has
not elapsed and observe the user instructions for the electrodes.
Attach the electrodes to the corresponding places on the body of the patient (see Section 5.5). Then fasten the electrode
cable via the contact option for the snaps on the electrodes.
6.3 Switching the ECG measuring unit on/off
To switch on the ECG measuring unit, press the power button for 3 seconds. On power on the device carries out an
automatic self-test. If an error code appears on the display follow the instructions in Section 6.7 below and Section 8.
Fault Finding. The ECG measuring unit is ready for operation when the battery symbol and the loudspeaker symbol
appear on the display.
CAUTION: Do not use the device if an error code is displayed, see section 6.7 for a complete list of error codes.
Briefly pressing the power button with the device switched on activates the backlighting of the display. This switches off
automatically after 5 seconds.
Pressing and holding the power button switches the ECG measuring unit off. An acoustic signal sounds when it does so.
6.4 Electrode contact
Fasten the electrodes to the patient (see Section 5.4 and 5.5). The ECG measuring unit automatically checks the contact
quality and indicates a poor electrode contact by flashing the respective point on the display. If one or more points flash
check the contact of the corresponding electrode(s) and replace if necessary. The ECG transmission begins when all
electrodes are connected. If one of these four electrodes R, L, F and N is removed or falls off during recording, the ECG
signal transmission is interrupted. The recording is not interrupted if one of the V leads comes loose.
6.5 Heart rate monitoring
The ECG measuring unit monitors the heart rate of the patient continuously after correctly applying the electrodes. The
heart rate is shown on the display, labeled “BPM”. In limited display mode, only the heart symbol flashes at the same rate
as the heartbeat. If the preset limits are exceeded or fallen short of, the device will emit a sound to indicate this. The
volume of this can be adjusted to 5 different levels or muted.
NOTE: The sound volume should be set so that it can’t be missed.
6.6 ECG data transmission
The receiving unit establishes the wireless connection to the ECG measuring unit via the interface. Once the connection
has been established, there is a short beep on the ECG measuring unit. An existing connection is indicated on the
display by the “Radio active” symbol. If the connection is lost because the user moves out of range of the receiver it
will emit a sound and the corresponding symbol disappears from the display.
NOTE: If there is no data transfer within five minutes of activating the device the ECG measuring unit switches off again
automatically.
NOTE: The range of the wireless transmission is approximately 10 m. Ensure that there are no obstacles between the
ECG measuring unit and the receiver unit to maintain a stable connection.
NOTE: If the Bluetooth connection is interrupted for longer than 15 minutes the ECG measuring unit switches off
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automatically.
With the monitor software, ECG data can be shown online on the PC. In addition, measured values can be saved and
revised (not available in every monitor software version). Observe the user instructions for the respective monitor
software.
6.7 Displays and signals
The ECG measuring unit can be operated in two different display modes:
In the complete display mode, the heart symbol flashes at the same rate as the heartbeat and the heart rate is
displayed as a number value.
In limited display mode, the heart rate is not displayed. Only the heart symbol flashes. Instead of the heart rate, the
following characters appear on the display: “???”.
A crossed-out loudspeaker symbol indicates that the sound is muted. The charge status of the power source is indicated
by a battery icon showing three bars for full batteries and no bars/icon flashing for discharged batteries.
If the ECG measuring unit detects an R wave, it emits a brief sound. This output can be deactivated via the receiver of
the ECG data. Furthermore, the heart symbol flashes on the display at the rate of the detected R wave.
The electrode connections are displayed by points. An open electrode is indicated by a respectively flashing point and a
connected electrode by a continuously illuminated point. Data transmission on the monitor only starts when all electrodes
are connected. If one of the electrodes loses contact, the device emits a warning sound. If the disconnected/failed
electrode is R, L, F or N the ECG signal transmission is interrupted until the electrode has been replaced or correctly
attached.The recording is not interrupted if one of the V leads comes loose.
If the measured heart rate is above or below the set limits the device will emit two short warning sounds.
The “Radio active” symbol indicates if there is a Bluetooth connection to the P.C. When the wireless connection is
established, the device emits a short sound. In the case of a broken connection e.g. if the patient moves out of the
monitor's receiving range, the device emits a pulsing sound for one minute.
All acoustic signals, except for the sound output for a detected R wave, can be muted by pressing the power button
briefly. After 3 minutes, the signal sounds automatically again if the cause is still present. Muting only applies for the
currently occurring signal. All other signals can still sound. If an event signal sound is muted, the crossed-out loudspeaker
symbol is illuminated on the display.
All acoustic outputs, except for warning signals when the connection is terminated can be permanently deactivated by
configuring via the PC monitor software.
ATTENTION: If the sound output is permanently deactivated via the monitor software, no alarm is sounded when an
electrode falls off or when the pulse thresholds are exceeded/fallen short of.
The display has backlighting, which can be activated by a short press of the power button and switches off automatically
after 5 seconds.
Figure 5: Labeling of the display
The following table offers a list of all occurring acoustic and optical signals which can be output by the ECG unit.
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Signal Acoustic Signal Optical Signal
Open electrode At the rate of the flashing icon Flashing of the corresponding point
on the display
Closed electrode - Illumination of the corresponding point
on the display
Leaving range Longer pulsating sound for 1 minute Radio symbol on display is
deactivated
Exceeding or falling short of the
configured threshold for the heart rate
Two brief sounds, one per second
R wave detected Brief sound Heart symbol flashes briefly
Switching off the device After pressing button for 2 seconds, a
2-second sound
-
Error message -
Data memory full -
Data memory almost full -
Radio active - Bluetooth is connected -
Crossed out loudspeaker - audio is
muted
-
7. CLEANING INSTRUCTIONS
7.1 Maintenance
To maintain the ECG measuring unit change the batteries as required. See also Section 5.1.
Remove the batteries if storing the device for a long period of time without using it to avoid damage to the device.
An annual service is recommended. Service and repairs should be carried out only by the manufacturer or by Service
Agents specifically approved by Vitalograph.
7.2 Disposal
The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted
municipal waste. Please note, that batteries must be disposed of separately.
7.3 Cleaning and disinfection of the surface of the device
Ensure the ECG measuring unit is turned off prior to cleaning/disinfecting. The device is not intended to be waterproof
and as such must not be submerged, have liquids poured or sprayed on it.
To clean, wipe the housing with a soft, moist cloth.
For disinfection use Incidin® Foam oder Mikrozid® AF Liquid or equivalent. Please refer to the specific manufacturers
instructions for use prior to disinfecting.
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CAUTION: Never submerge the device in disinfectant or other liquids as it may cause damage to it.
7.4 Cleaning and disinfecting the electrode cable
To clean the electrode cable, rub the cable off with a soft, moist cloth. Only use a mild cleaning agent to avoid damage.
Make sure you don’t pull too hard on the cables.
For disinfection, rub the cable off with a cloth soaked in Incidin® Foam or Mikrozid® AF Liquid. Please refer to the
specific manufacturers instructions for use prior to disinfecting.
CAUTION: Never submerge the cable in disinfectant or other liquids as it may cause damage to it.
7.5 Electrodes
If disposable adhesive electrodes are used, dispose of these immediately after use.
8. FAULT FINDING GUIDE
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Malfunction Possible causes Rectification
The ECG device will not turn on Dead batteries, reversed batteries. Exchange batteries for fully charged
ones. Check the polarity of the
inserted batteries.
The measuring unit cannot be detected
by other Bluetooth devices.
It is already paired with another
device.
Switch the device on and then press
the power button for at least 20
seconds until it beeps. The device is
now ready to be paired again and is
visible to other Bluetooth devices after
switching on again.
Issues caused by conflict with USB
3.0 hard drives/flash drive, internal
built in BT antenna, too many BT
devices or incorrect BT dongle used.
There are several issues that may
cause an issue with detection/pairing,
see section 17. Troubleshooting guide
for pairing the BT12 for details on
resolving all known issues.
You are prompted to enter a PIN
number during pairing.
The ECG device is being newly paired
with a monitor.
Please enter “1111” during this
process.
After switching on, the display
continuously shows an error code.
PCBA fault.
Switch off the device. Take out the
batteries and put them back in.
Afterwards, switch on the device
again. If the error code is still present
stop using the device and contact
Vitalograph.
The “Radio active” symbol does not
appear on the display or disappears
from the display during use.
The wireless connection cannot be
established or has been broken.
Reduce the distance to the receiver
unit (<10m) and remove any existing
obstacle. If necessary, carry out
pairing again.
See section 17. Troubleshooting
guide for pairing the BT12 for details
on resolving all known issues.
Displaying too few channels for desired
12-channel use.
Incorrect configuration. Configure the ECG measuring unit for
12-channel use
No warning sounds for critical events. Loudspeaker is muted or is defective. Check the configuration of the
loudspeaker. Muting is indicated on
the display by the crossed-out
loudspeaker symbol. If the sounds are
enabled and the warning sounds are
still missing it is likely a defective
speaker, contact the manufacturer.
Pulse frequency is not shown on the
display.
The ECG device is in limited display
mode.
Check the configuration of the display
mode and reconfigure if required.
One or several electrode contact points
flash despite all electrodes being
connected.
The electrode contact is poor.
The cable is defective.
Check the positioning and the skin
contact of the electrodes. Press the
electrodes on firmly. If necessary,
shave any hair or clean the skin.
Replace the electrode. Use electrode
gel/spray to improve contact.
If the above measures do not resolve
the issue the cable could be defective.
Replace the ECG cable.
Device sounds 2 seconds on, 2
seconds off, for 1 minute.
Wireless connection has been
interrupted.
Reduce distance (<10m) to the
receiver unit and/or remove any
obstacles.
Device emits a sound at the same
frequency as the flashing of the
electrode contact points.
An electrode has come loose during
measurement.
Check the electrode contact and
replace the electrode if necessary.
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If there are errors which cannot be rectified immediately using the solutions above, contact Vitalograph. Stop using the
device to avoid greater damage.
Electrode cables and the fastening clip can only be replaced by the manufacturer/dealer.
9. CUSTOMER SERVICE
Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by
Vitalograph.
For the names and addresses of approved Vitalograph Service Agents or to arrange training, please refer to the contact
information at the start of this manual.
10. CONSUMABLES AND ACCESSORIES
Cat. no Description
41384 2 x 1.5V AA non-rechargeable batteries
41301 Electrodes
11. EXPLANATION OF SYMBOLS
Symbol Description
Defibrillator-proof application part of type BF
Application part of type BF
Disposal according to electronic scrap ordinance
Radio symbol
Manufacturer
Date of manufacture
Speaker/audio muted
12. TECHNICAL SPECIFICATIONS
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Feature Value
Product class in acc. with 93/42/EWG (MDD) IIa
Dimensions W x H x D in cm 6.1 x 10.6 x 2.3
Weight, incl. cable 210 g incl. batteries (154 g without batteries)
Temperature range
- Operation
- Storage (without batteries)
T = 0…50 °C
T = 0…50 °C
Air pressure range 700…1060 hPa
Power supply 2 * AA batteries (1.5 V) or rechargeable batteries (1.2 V)
Current consumption at 3 V
- Operation
- Stand-by
148 mA (BT12)
37 mA (BT12)
Data transmission Wireless, standard Bluetooth 2.1
Intermediate data memory (data saving mode) Is sufficient for at least 6 minutes of ECG
Classification in acc. with 60601-1
- Type of protection against electric shock
- Degree of protection against electric shock
Device with internal power supply
Type BF
Electromagnetic compatibility (EMC)
in acc. with 60601-1-2
- Noise suppression
- Immunity to interference
EN 55011
EN 61000-4 parts 2, 3, 6, 8
Degree of protection against penetration of water IPX3
Variants BT12: 12-channel, 3 leads acc. to Einthoven, 3 acc. to
Goldberger, 6 Wilson leads
Electrodes Standard clip ECG electrodes, bio-compatible, CE marked,
single use.
Signal output Pulse frequency exceeded/fallen short of.
Missing signal / connection termination
Electrode loss
Sound pressure level of a signal can be regulated over 5
levels
37 dB – 55 dB
Product liability Annual service recommended for product life of 5 years.
Wireless transmission Approved in accordance to R&TTE directive transmitter
module marked by CE, manufactured by MITSUMI
incorporated to OEM product.
13. CE MARK
Marking by the symbol indicates compliance of the Vitalograph BT12 ECG to the Medical Devices Directive of
the European Community. Such marking is indicative that the Vitalograph BT12 ECG meets or exceeds the following
technical standards:
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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The BT12 is intended for use in the electromagnetic environment specified below. The customer or the user of the
BT12 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions CISPR 11 Group 1 The BT12 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 B The BT12 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
not applicable
Voltage Fluctuations/ Flicker
Emissions IEC 61000-3-3
not applicable
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The BT12 is intended for use in the electromagnetic environment specified below. The customer or the user should
assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment
Electrostatic Discharge
(ESD) IEC 61000-4-2 ±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical Fast
Transient/Burst IEC
61000-4-4
±2 kV
for power supply lines
±1 kV
for input/output lines
not applicable Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
not applicable Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage Dips, Short
Interruptions and Voltage
Variations on Power Supply
Input Lines IEC 61000-4-11
<5% UT (>95% dip in UT)
for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in UT)
for 5 sec
not applicable Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the BT12 requires continued
operation during power
mains interruptions, it is
recommended that the BT12
be powered from an
uninterruptible power supply
or a battery.
Power Frequency (50/60
Hz) Magnetic Field
IEC 61000-4-8
3A/m
3A/m (50/60Hz)
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.
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