boso TM-2430 PC2 User manual

TM-2430 PC2
Instruction manual

2
Contents of package .......................................................................4
Overview of the device ...................................................................5
Display screen.................................................................................6
Introduction / Purpose.....................................................................7
Area of use and safety instructions.................................................8
Before first use..............................................................................10
Selecting and connecting the cuff.................................................11
Fitting protective covers (optional) ...............................................12
Fitting the cuff...............................................................................13
Taking readings
with the boso TM-2430 PC2..........................................................14
Starting automatic interval control ...............................................14
Automatic inflation pressure adjustment ......................................15
Maximum inflation pressure restriction ........................................15
Taking a manual reading...............................................................15
Interrupting readings ....................................................................15
Finishing a reading and transferring results ..................................16
Table of contents

3
Replacing batteries .......................................................................17
Charging batteries ........................................................................18
Important information on battery charging ..................................18
Error messages..............................................................................20
After use / cleaning and disinfection.............................................23
Disposal instructions.....................................................................23
Warranty Conditions / customer service........................................24
Accessories ...................................................................................25
Technical data...............................................................................26
Clinical test ...................................................................................27
Metrology test instructions ...........................................................28
EMC information...........................................................................29

4
Contents of package
24-hour blood pressure
measuring device
TM-2430 PC2
Case
Battery
charger
Two sets of batteries, with three batteries
per set
(one set is already inserted in the device)
Cuff for adults
(standard CA11/washable)
Hip bag with
detachable straps
and belt
Instruction manual for:
TM-2430 PC2
battery charger
profile manager
One boso profile manager
CD-ROM
USB cable
(serial interface types are also available)
TM-2430 PC2
Instruction manual

5
A S
K
B M
Overview of the device
START/STOP button AUTO button
DAY/NIGHT button
Cuff connection
socket
START/STOP button:
– starts a reading manually (see page 15)
– interrupts a current reading (see page 15)
AUTO button (DAY/NIGHT button):
– 5 seconds: starts automatic
interval control (see page 14)
– briefly in sleep mode: switch from day to
night interval
and from night to
day interval (see page 14)
A: Automatic mode active
S: Sleep mode active
K: Irrelevant
: Irrelevant
B: Battery flat (no more readings can be taken and
no more data can be transferred)
M: Memory full, 350 readings
(no more readings can be taken)
Please read this manual carefully before using
the device.

6
Display screen
Systolic blood pressure
SYS
Time
Diastolic blood pressure
DIA
Error message
Pulse
PUL

7
Display screen
Time
Introduction
Dear customer,
Thank you for purchasing this boso blood pressure measuring device.
The boso brand offers optimum quality and accuracy. 96% of German
doctors currently use boso blood pressure measuring devices. This
device has undergone our strict quality control procedures and will
be a reliable partner in monitoring your patients’ blood pressure.
mPlease read this manual carefully before using the device for
the first time, because blood pressure readings can only be taken
properly if the device is used correctly.
The “➡“ symbol in this manual indicates action to be taken by the
user.
Please contact your specialist supplier or the manufacturer for help
in preparing for first use, using the device or maintenance (contact
details are given on the inside back cover of this manual).
If you sell the device, please include this manual.
This blood pressure measuring device complies with European
requirements that are set out in the German Medicinal Products Act
(mark: CE 0124) and with European Standard 1060, part 1: “Non-
invasive sphygmomanometers – general requirements“ and part 3:
“Supplementary requirements for electromechanical blood pressure
measuring systems“.
In accordance with the Medicinal Products Operator Decree, metro-
logy tests (see page 28) must be conducted at regular intervals when
the device is used in a medical context.
Purpose
Non-invasive recording of systolic and diastolic blood pressure and
pulse frequency in humans over a period of typically 24 hours.

8
Area of use and safety instructions
The boso TM-2430 PC2 blood pressure measuring device operates
according to the oscillometric principle of measurement. The device
is used to take readings over a 24-hour period. It is suitable for use
both in hospitals and in community medicine. It is not suitable for
use on young children, infants or on unconscious patients without
supervision.
N.B.
mDo not allow the air tube to be compressed or its diameter to
be reduced.
mExcessively frequent readings can impair circulation and con-
sequently lead to injury.
mThe cuff must not be placed on top of wounds, as this could
lead to further injuries.
mEnsure that the cuff is not placed on an arm of which the arte-
ries or veins are undergoing or have undergone medical treatment,
e.g. a shunt.
mIn the case of women who have had a mastectomy, do not
place the cuff on the arm on the side on which the operation took
place.
mMedical devices being used on the same arm at the same time
may malfunction.
mThe device is not protected against the possible effects of high-
frequency (HF) surgical devices.

9
mIf any liquid has been spilt on the device, immediately remove
the batteries and send the device to the customer service depart-
ment (see page 24 for the address) for inspection.
mOnly use the batteries contained in the pack which you recei-
ved.
mCheck the batteries for damage. Never use damaged batteries.
lThere is no known risk due to defibrillator discharge.
lMedical electrical devices are subject to particular precautions in
relation to electromagnetic compatibility, and must be installed
and used in accordance with the EMC information given on pages
29 and 30.
mNotify the manufacturer immediately of any unexpected opera-
tional status or any event which has or could have caused damage
to health.
The manufacturer is only liable for effects on the safety, reliability
and performance of the device if:
lAssembly, extension, resetting, alterations or repairs have been
carried out by individuals approved by the manufacturer.
lThe device is used in accordance with the manual.
mThis device must be maintained by trained and approved staff.
Safety instructions

10
Before first use
➡ You should charge the batteries supplied with the device before
starting to use the boso TM-2430 PC2. Follow the instructions
given on pages 17 and 18 (replacing and charging batteries).
Then install the boso profile manager.This software will allow you
to programme the blood pressure measuring device and assess
stored data.

11
Selecting the cuff and connecting it
to the TM-2430 PC2
Selecting the cuff
Only use genuine CA11, CA12 and CA13 cuffs.
Select the correct cuff for the arm circumference printed on it.
Connecting the cuff
Screw the air connection plug of the cuff tube directly into the air
connection socket of the blood pressure measuring device (see
figure 1).

12
Fitting protective covers (optional)
If necessary you can also use protective covers to prevent soiling (see
accessories on page 25). Apply the protective covers as described
below:
Protective cover Cuff
➡ Pull the cuff through the loop in the protective cover
➡ Attach the protective cover to the cuff by means of the Velcro
fasteners.
Care instructions for protective covers: machine wash, maximum
temperature 60°C

13
Fitting the cuff
➡ Place the cuff on the bare upper arm so that the yellow marking
is lying over the Arteria brachialis. Most people have higher blood
pressure in the left arm, which is why blood pressure is measured
in the left arm. However, in individuals who have higher blood
pressure in the right arm, readings should be taken on the right
arm.
The cuff should be placed about 2-3 cm above the elbow. It must
not be too tight; you should still be able to fit a couple of fingers
between the arm and the cuff.
mIt is important that the cuff does not interfere with circulation
once the reading has been taken. Place the cuff tube over the shoul-
der (see figure 1) and tape it to the shoulder. The blood pressure
measuring device is carried in the bag, which is supported either by
a belt which the patient is wearing or by the straps supplied.
Figure 1
Cuff
connection
socket to the
TM-2430
Bag
Air connection
plug
Yellow
marking
2-3 cm
Tape
➡ Pull the cuff through the loop in the protective cover
➡ Attach the protective cover to the cuff by means of the Velcro
fasteners.
Care instructions for protective covers: machine wash, maximum
temperature 60°C

14
Taking readings with the boso TM-2430 PC2
➡ Once the cuff has been correctly fitted, a test reading can be taken
with the boso TM-2430 PC2 using the START/STOP button (the
result will only be displayed if the device has been programmed
accordingly). If this reading is successful, automatic interval con-
trol (see below) can be started. The test reading will be assessed
along with the other readings.
mPlease note that the oscillometric method of measuring blood
pressure can give inaccurate results in some types of patients.
Individuals with cardiac dysrhythmia, arteriosclerosis, circulation
disorders or diabetes, or who have a pacemaker, should undergo a
comparative reading with an auscultatory device before you start to
take readings. The same applies to pregnant women.
External disturbances, e.g. movements of the measuring arm, dis-
turbing vibrations e.g. driving by car or the use of public transport
during the measurement can lead to incorrect measurements.
For this reason, the protocol recorded by the patient has to be exa-
mined and included in the assessment.
Starting automatic interval control
➡ To start automatic interval control, hold the black button down
until the letter “A“ appears on the display screen of the blood
pressure measuring device and a brief audible signal is emitted
(after about 5 seconds) to indicate that the button has been held
down for long enough.
When the device is being used in sleep mode, the patient must press
the black button before going to sleep. An “S“ for sleep appears on
the display screen next to “A“ for automatic. The patient must press
the black button again after getting up, and the “S“ on the display
screen then disappears.

15
Taking readings with the boso TM-2430 PC2
Automatic inflation pressure adjustment
(only in automatic interval control mode)
For the first five readings in automatic interval control mode, the
boso TM-2430 PC2 inflates to approximately 185 mmHg. From the
6th reading onwards, the inflation pressure is adjusted according to
the last systolic results. From the 6th reading onwards in automa-
tic interval control mode, the inflation pressure is approximately 40
mmHg above the weighted average of the most recently measured
systoles (the most recent systole has a higher weighting).
If this inflation pressure is not sufficient, the device automatically
reinflates to approximately 60 mmHg above the original inflation
pressure.
Maximum inflation pressure restriction
The boso TM-2430 PC2 has the ability to restrict the inflation pres-
sure. See the boso profile manager manual for details of how to do
this.
Taking a manual reading
Patients can start a manual reading in addition to the automatic
readings at any time.This can be useful if a patient has been exposed
to physical or mental strain, for example.This is done by pressing the
START/STOP button.
mInterrupting readings
➡ To interrupt a reading, press the START/STOP button on the
TM-2430 PC2. If you wish to restart the reading subsequently,
press the START/ STOP button at any time to start a manual rea-
ding.
Taking readings with the boso TM-2430 PC2

16
Finishing a reading and transferring results
➡ You must switch off automatic interval control as soon as the
patient has handed in the device after a 24-hour reading has been
taken. Hold the black button down until the “A“ on the display
screen of the blood pressure measuring device has disappeared
(about 5 seconds).
Then connect the TM-2430 PC2 to the computer via the PC con-
nection cable. Transfer the data according to the instructions in the
boso profile manager. You are strongly advised to empty the results
memory once the results have been transferred.

17
Replacing batteries
We recommend that the set of batteries in the device should be
replaced by a freshly charged set once a 24-hour reading has been
completed.
To avoid data loss, the data stored in the boso TM-2430 PC2 is buffe-
red by means of an internal battery, which is automatically charged
by the external batteries.A fully-charged internal battery stores data
for approximately 10 days.To charge the internal battery fully before
using the device for the first time, keep the device switched on for
approximately 24 hours with fully charged external batteries.
Replace the batteries as follows (see figure 2):
➡ Open the internal battery compartment cover
➡ Switch off the device
➡ Remove the flat batteries and insert charged batteries, taking
care to respect polarity
➡ Switch on the device
➡ Close the internal battery compartment cover
Figure 2
Internal
battery
compartment
cover
Step 1
Step 5
Charged
batteries
Flat batteries
ON/OFF
switch
Step 4
Step 2
Step 3
Finishing a reading and transferring results

18
Charging batteries
Place the batteries in the charger and then plug it in. Once the green
LED lights up, the batteries are being charged. Completely flat batte-
ries take around 42 hours to charge.According to the battery charger
manual, it will normally take only around 10 hours to charge batte-
ries that have been used to perform a 24-hour reading.
mImportant information on battery charging
In order to ensure that the TM-2430 PC2 functions properly over a
24-hour period, only use batteries with the following rated proper-
ties: min. 1500 mAh; 1.2 V; NiMH.
In addition to the three external batteries required for power supply,
the TM-2430 PC2 also has an internal battery to protect the results
and programme settings within the device.
Follow the instructions given below to prevent the error code E00
appearing (see page 20). This code appears on the display screen of
the TM-2430 PC2 when the internal battery is flat:
➡Insert charged batteries in the device even when it is not in use.
➡Leave the ON/OFF switch in the ON position whenever charged
batteries are in the device.This keeps the internal battery charged
at all times. If the switch is set to the OFF position, the power
supply to the internal battery is interrupted and the settings of
the TM-2430 PC2 will be lost after approximately 10 days.
➡Please replace the batteries in the device with a set of freshly
charged batteries before fitting the device to a patient.

19
Charging batteries
If the device is not used for an extended period (4 weeks or more), set
the switch in the internal battery compartment to OFF and remove
the external batteries in order to prevent any damage that may be
caused by leakage.
The internal battery will need to be recharged and the device will
need to be reprogrammed before the device can be used on a patient.
➡Insert freshly charged batteries.
➡ Set the switch in the internal battery compartment to ON and
leave the TM-2430 PC2 switched on for at least 2 hours.The inter-
nal battery will recharge during this time.
➡Reprogramme the device.
➡Replace the batteries with a set of freshly charged batteries
before fitting the device to a patient.
Charging batteries

20
Error messages
Error Cause Solution
code
E00 Device not Reprogramme device
programmed
E03 Zero point cannot Deflate cuff
E90 be aligned completely
E04 Batteries flat Charge or replace
batteries
E05 Leak Remove cuff from
device and
reconnect.
Contact your distributor
if the error occurs
repeatedly.
E06 Pressure above 320 mmHg The arm must be kept
still while the reading
is being taken.
E07 Operator has interrupted the
reading using the
START/STOP button
E08 No oscillations, or no The arm must be kept
E10 measurable oscillations. still while the reading
Maximum pressure has been is being taken.
set too low. Select higher maximum
pressure.