IEM Tel-O-Graph BT plus User manual

Operating manual
EN
Tel-O-Graph®BT plus

2
Tel-O-Graph®BT plus
Blood pressure monitor
IEM GmbH
Cockerillstr. 69
52222 Stolberg
Germany
Telephone: [phone]
Fax: [phone]
E-mail: [email protected]
Website: www.iem.de
The content of this operating manual must not be reproduced or published without the written approval of IEM
GmbH.
© IEM GmbH 2018. All rights reserved.

Table of contents
3
EN
Table of contents
Table of contents...................................................... 3
1Introduction ...................................................... 4
1.1 Clinical validation..............................................5
1.2 CE Mark............................................................5
1.3 Contents ...........................................................5
2Instructions for use ......................................... 6
2.1 Intended use..................................................... 6
2.2 Improper use..................................................... 6
2.3 Essential Performance .....................................7
3Safety................................................................. 8
3.1 Explanation of the safety symbols....................8
3.2 Important patient information............................ 9
3.3 Important device instructions..........................12
4Description of device..................................... 15
4.1 Blood pressure monitor ..................................15
4.2 Blood pressure cuff.........................................16
4.3 Display............................................................ 17
4.4 Ambient conditions .........................................18
5Preparing the measurement ......................... 19
5.1 Unpacking.......................................................19
5.2 Inserting the batteries.....................................19
5.3 Switching the blood pressure monitor on/off..21
6Measuring blood pressure and pulse.......... 22
6.1 Before measuring........................................... 22
6.2 Putting the blood pressure cuff on ................. 22
6.3 Correct posture............................................... 25
6.4 Measuring....................................................... 26
6.5 Stopping the measurement............................ 27
7Transferring readings via Bluetooth®.......... 28
7.1 Active pairing (Bluetooth modem).................. 28
7.2 Passive pairing (tablet, smartphone) ............. 29
8Memory ........................................................... 30
8.1 Saving readings.............................................. 30
8.2 Deleting readings from the blood pressure
monitor............................................................ 31
9Cleaning and disinfection............................. 33
9.1 Cleaning ......................................................... 33
9.2 Disinfection..................................................... 35
10 Maintenance ................................................... 36
11 Disposal.......................................................... 37
12 Error messages.............................................. 38
12.1 Blood pressure measurement errors ............. 38
12.2 Communication error...................................... 41
13 Technical data and symbols......................... 42
14 Warranty and repairs..................................... 46
15 Manufacturer’s EMC guidelines ................... 47

Introduction
4
1 Introduction
Thank you for choosing the Tel-O-Graph®BT plus
upper-arm blood pressure monitor.
Read this operating manual carefully before use and
keep it in a suitable place so that the information is
available when required.
Tel-O-Graph®BT plus is a fully automated blood
pressure and pulse monitor that enables automatic
transmission by means of a Bluetooth®.
The Tel-O-Graph®BT plus additionally records the
pulse waveform. This is transferred together with the
blood pressure reading.
The Tel-O-Graph®BT plus can be integrated in tele-
monitoring systems that may involve different products
for data transmission and storage. Such products, and
the data base used to store and assess the blood
pressure readings is not part of the Tel-O-Graph®BT
plus, but is within the responsibility of the care provider
that you have allowed to monitor your blood pressure
readings. You may not have direct access to the
database, and need to contact the care provider, if you
have any question related to the stored data.
This operating manual explains the blood pressure
monitor and accessories in the order in which you will
operate the monitor and also use later.
If you have any questions about our services or
products, feel free to contact us.

Introduction
5
EN
1.1 Clinical validation
The accuracy of the device's measurements has been
certified in accordance with ISO 81060-2:2013.
1.2 CE Mark
The Tel-O-Graph® BT plus meets the
requirements of the
▪93/42/EEC (MDD),
▪2014/53/EU (RED),
▪2011/65/EU (RoHS) guidelines
and bears the CE mark.
IEM GmbH hereby declares that the Tel-O-Graph®BT
plus corresponds to the 2014/53/EU (RED) guideline.
1) External reference
2) The complete text of the EU declaration of conformity
is available at the following website address:
www.iem.de.
1.3 Contents
Contents
▪Blood pressure monitor
▪Blood pressure cuff "M"
(Arm circumference: 24-32 cm (9.5-12.6 in))
▪Operating manual
▪Batteries (4x, AA, alkaline)
Optional accessories
▪Blood pressure cuff "S"
(Arm circumference:20-24 cm (7.9-9,5 in))
▪Blood pressure cuff "L"
(Arm circumference: 32-38 cm (12.6-15.0 in))
▪Blood pressure cuff "XL"
(Arm circumference: 38-55 cm (15.0-21.7 in)

Instructions for use
6
2 Instructions for use
2.1 Intended use
The Tel-O-Graph®BT plus is intended for the home
measurement of blood pressure and pulse on the upper
arm in adults.
The blood pressure monitor is suitable for individuals
with an arm circumference of 20-55 cm (7.9-21.7 in)
when used with the corresponding monitor cuff size.
The data measured is automatically transmitted.
The Tel-O-Graph®BT plus additionally records pulse
waveform data.
3) WARNING
Self-diagnosis and self-treatment on the basis of the
results is dangerous!
▪Do not undertake any treatment and/or take
medication as a result of the measured values
without consulting your doctor.
▪Follow your doctor’s instructions.
2.2 Improper use
The blood pressure monitor must not be used for
newborns, during surgery, in the vicinity of MRI
scanners or other strong magnetic fields, or for clinical
monitoring of patients and during transport of patients.
The blood pressure monitor must not be left within the
reach of unsupervised children or be used by those with
limited mental competencies.
It must not be used for any purpose other than the
process of measuring blood pressure described herein.
Note
▪The device has not been tested for use
with pregnant women or those suffering
from preeclampsia.
▪If you are taking medication to alter blood
clotting, consult your doctor before using
the blood pressure monitor.

Instructions for use
7
EN
2.3 Essential Performance
The essential performance features are defined as
blood pressure measurement with:
▪Error tolerances of the pressure gauge and
measurement results within the required limits
according to IEC 80601-2-30.
▪Maximum change value in blood pressure
determination according to IEC 80601-2-30.
▪Power delivery (pressure supply to the cuff)
within the set limits according to IEC 80601-2-
30, EN 1060-3
▪An error is issued in the event that successful
blood pressure measurement is impossible.
The blood pressure monitor does not emit an alarm in
the sense of IEC 60601-1-8. The blood pressure
monitor is not provided to be used in conjunction with
RF surgery monitors or for the clinical monitoring of
patients, such as on an intensive care unit.
Basic safety means that the patient cannot be
endangered by any automatic device procedure.
In the event of an unclear status or state of the blood
pressure monitor, the blood pressure monitor must
enter standby mode by the device releasing the air in
the cuff. The cuff is not automatically pressurised, to do
so, the device must be initiated manually.

Safety
8
3 Safety
This section explains all the safety information for the
device.
Read this section carefully before using the blood
pressure monitor.
Contact your doctor before using the device if you are
pregnant, are taking medication to alter blood clotting or
if you have been diagnosed with cardiac arrhythmia,
coagulation disorders or arteriosclerosis.
3.1 Explanation of the safety symbols
4) WARNING
Short description of the danger
This warning symbol in connection with the signal
word WARNING indicates a possible or immediately
threatening danger.
5) Non-adherence may lead to the mild, moderate
injuries or to the most severe injuries or death.
ATTENTION
Short description of the danger
6) This warning symbol, in connection with the signal
word ATTENTION, indicates possible material
damage.
7) Non-adherence may lead to damage to the products
or their accessories.
8) NOTE
9) The signal word Note indicates further information
about the Tel-O-Graph®BT plus or its accessories.
10) External reference
11) Indicates reference to external documents in which
further information may optionally be found.

Safety
9
EN
3.2 Important patient information
12) WARNING
Danger as a result of self-diagnosis
▪Do not undertake any changes to your treatment
and/or take medication due to the measured
values without consulting your doctor.
▪Follow your doctor’s instructions.
13) WARNING
14) Danger of blood flow disruptions as a result of
putting on and pumping up a cuff on limbs with
an intra-vascular drip or intra-vascular treatment
or with an arteriovenous (AV) shunt.
▪Do not put the Tel-O-Graph®BT plus on when
you have an intra-vascular drip or arteriovenous
(AV) shunt in your arm.
15) WARNING
Danger of tissue bleeding or haematoma.
▪When using the blood pressure monitor, make
sure it does not impede the blood circulation in
your arm.
▪If you have sensitive bodily tissue, despite the
correct positioning of the cuff, it can still result
in tissue bleeding or haematoma.
▪If you are taking medication to alter blood
clotting or suffer from coagulation disorders,
consult your doctor before using the blood
pressure monitor.
16) WARNING
17) Danger of injury as a result of allergic reactions to
the cuff material
▪In the event of pain or allergic reactions, remove
the cuff.
▪Pay attention to hygiene concerns.

Safety
10
18) WARNING
Danger of injury as a result of using unapproved
accessories
▪Only use accessories approved by the
manufacturer and distributed by the trader or
manufacturer.
▪Read the respective information provided by the
manufacturer before using the accessories for
the first time.
▪Before use, check accessories in relation to the
manufacturer specifications.
19) WARNING
Danger of injury as a result of putting on or
pumping up a cuff on an arm on the same side of
the body as a mastectomy has been carried out
▪Do not put the Tel-O-Graph®BT plus on an arm
on the same side of the body as a mastectomy
has been carried out.
20) WARNING
21) Danger of a temporary loss of function of a
present electrical medical device as a result of
putting on or pumping up a cuff if you are
wearing a further electrical medical device for
monitoring on the same limb.
▪Only put the Tel-O-Graph®BT plus on if you are
not wearing any other medical electrical monitor
on your arm.
22) WARNING
23) Danger of fluid occurrence when using the
batteries incorrectly
▪Liquid that escapes from the batteries due to
mishandling can cause skin irritation. If you
come into contact with the liquid, rinse it away
with plenty of water. If the liquid comes into
contact with your eyes, do not rub your eyes but
instead immediately rinse them with water for
10 minutes and contact a doctor without delay.

Safety
11
EN
24) WARNING
25) Danger of blood flow interruptions as a result of
steady cuff pressure or too frequent measuring
▪Ensure the cuff hose is in the correct position
and take care that the cuff hose is not knotted,
pinched, kinked or stretched.
▪If you notice pain, swelling, reddening or
numbness in your arm, around which the cuff is
placed, inform your doctor. (It is expected that
some mild to moderate discomfort may be
experienced during a blood pressure
measurement.)
▪Measurement can be interrupted at any stage by
pushing any button. This deflates the cuff and
the cuff can be removed.
26) WARNING
Danger of strangulation by the cuff hose
▪Persons (including children) who are unable to
use the blood pressure monitor safely due to
their physical, sensory or mental capabilities or
their inexperience or lack of knowledge must
not use this blood pressure monitor without
supervision or instruction by a responsible
person.
▪The blood pressure monitor may not be used
by those with limited mental competencies.
(Keep out of reach.)
▪Do not wrap the cuff or the cuff hose around
your neck!
▪The cuff must only be worn on the upper arm!
▪Check the correct positioning of the cuff.
▪If you notice pain, swelling, reddening or
numbness in the arm around which the cuff is
placed, inform your doctor. (It is expected that
some mild to moderate discomfort may be
experienced during a blood pressure
measurement.)

Safety
12
▪Measurement can be interrupted at any stage
by pressing the button. This deflates the cuff
and the cuff can be removed.
3.3 Important device instructions
ATTENTION
27) Equipment failure
▪The device must not be used in the vicinity of
magnetic resonance imaging apparatus or in
the direct proximity of another electrical
medical monitor.
▪The device is not suitable for simultaneous
use with high frequency surgery monitors.
▪Do not drop the blood pressure monitor and
do not place objects on top of it.
▪Do not use the device directly adjacent to
other devices or stacked with other devices,
as this may result in malfunction. If operation
in the manner described above becomes
necessary nevertheless, this device and the
other devices should be monitored to ensure
that they are functioning correctly
▪Use of components other than those supplied
with the device may result in measurement
errors, as other equipment (e.g. transformers
and cables) may cause increased
electromagnetic interference or have reduced

Safety
13
EN
electromagnetic immunity. You should
therefore only use genuine IEM accessories.
▪The cuff and the hose are made of a material
that does not conduct electricity. They thus
protect the device against the effects of
discharging a defibrillator. In the event of
discharging a defibrillator, the device itself
must not touch the patient since the device
can be damaged as a result of such a
discharging and can result in the incorrect
value being displayed.
ATTENTION
Warranty
▪Do not open the housing of the Tel-O-Graphs®
BT plus, otherwise any warranty becomes void.
ATTENTION
Batteries
▪Remove the batteries from the battery
compartment when they no longer have any
charge or if you do not expect to use the blood
pressure monitor for a longer period of time.
▪Do not throw batteries into fire and never expose
them to high temperatures!
▪Do not attempt to recharge the batteries. Do
not attempt to open or short-circuit the
batteries. There is a risk of explosion.

Safety
14
ATTENTION
Electric fields
▪Measurements may be faulty if the device is
operated in the vicinity of strong electrical
fields. Do not operate the blood pressure
monitor near:
▪High-voltage power lines
▪Microwave devices
▪Portable and mobile RF transmitters, such as
mobile phones for example, may affect the
blood pressure monitor. Transmission of data
via mobile communication networks may be
disrupted by other devices, even if those
devices comply with the applicable
transmission requirements specified by CISPR.
You should therefore ensure that the Tel-O-
Graphs®BT plus is at least 30 cm (12 inches)
from any portable RF communications
equipment.
ATTENTION
28) Fluid damage to the blood pressure monitor
▪Liquid must not penetrate the device. If you
believe that liquid has penetrated the device
during cleaning or use of the blood pressure
monitor, the device must no longer be used.
▪If the blood pressure monitor is exposed to
moisture, switch the blood pressure monitor off
and remove the batteries. Immediately inform
your healthcare provider.
Note
▪This blood pressure monitor is intended for
use in home healthcare environments and
professional healthcare institutions, such as
first aid facilities and hospitals.

Description of device
15
EN
4 Description of device
4.1 Blood pressure monitor
Fig. 1: Blood pressure monitor
1
Display
4
Battery cover
2
Infrared interface (for service)
5
Air hose socket
3
button

Description of device
16
4.2 Blood pressure cuff
Fig. 2: Blood pressure cuff
1
Blood pressure cuff
2
Air hose
3
Air hose connection

Description of device
17
EN
4.3 Display
Fig. 3: Display
1
When this appears: Battery empty
6
Number of pulse beats per minutes
2
Display of systolic (upper) value
7
Pulse detected
3
Data transfer
8
Number of measurement values
4
Bluetooth®
9
Display of diastolic (lower) value
5
Infrared communication

Description of device
18
4.4 Ambient conditions
ATTENTION
Extreme temperatures, humidity or air pressure can influence measurement accuracy. Please follow the operating
instructions.
▪Never store the blood pressure monitor outside a temperature range of -25 °C to +70 °C.
▪Never use the blood pressure monitor outside a temperature range of +5 °C to +40 °C.
▪Only store or use the blood pressure monitor at an air humidity (not condensing) of 15% to 93%.
▪Extreme temperatures, air humidity (not condensing) or heights can affect the performance of the blood pressure
monitor.

Preparing the measurement
19
EN
5 Preparing the measurement
5.1 Unpacking
Note
All parts included in delivery package have been
properly packed and checked for completeness
and functionality. Should the product be
incomplete, damaged or defect, please inform
your healthcare provider immediately.
WARNING
Risk of strangulation from the cuff hose and blood
pressure cuff!
▪Keep the blood pressure cuff out of the
reach of children!
1) Unpack the entire delivery package and check
that everything is present.
2) Inspect the blood pressure monitor to ensure
there is no visible damage on the outside. If the
blood pressure monitor is damaged, have it
repaired before use.
3) Keep the packaging so that it can be safely
packaged at a later date.
5.2 Inserting the batteries
Fig. 4: Opening the battery cover

Preparing the measurement
20
Note
▪Insert the batteries while holding the blood
pressure monitor in your hand.
▪Take care not to activate the button on the
front!
▪By pressing the button when inserting the
batteries, you will enter the pressure gauge
mode used for servicing purposes. Remove
the batteries and insert the batteries again.
1) Open the battery cover on the underside of the
blood pressure monitor.
2) Insert four batteries (AA, alkaline), with the poles
aligned correctly.
3) Close the battery cover.
The blood pressure monitor switches on
automatically, carries out a display test and
displays the start screen. (see Fig. 5 and Fig. 6).
WARNING
Make sure that all segments are displayed by the
screen. Inform your healthcare provider if the
display is damaged.
Fig. 5: Test screen