TONOPORT V

Ambulatory Blood Pressure Monitor

Version 1

Operator's Manual
2001589-007 GA (e) Revision A
 Contents

1 Introduction to TONOPORT V, Safety Information 5

2 Controls and Indicators 8

3 Setting Up the TONOPORT V BP Monitor 9

4 Application 13

5 Data Output 16

6 Error Codes 18

7 Cleaning, Maintenance 19

8 Technical Specifications 21

9 Order Information 22

Appendix
EU Declaration of Conformity 23
Sample Report 24
Index 28

Revision History
This manual is subject to the Marquette Hellige change order service. The revision code, a letter
that follows the document part number, changes with every update of the manual.

Part No./Revision Code Date Comment

2001589-007 A January 2000 Initial Release

2001589-007 A TONOPORT V 3
 General Information
General Information
• The product TONOPORT V bears the CE mark
CE-434
indicating its compliance with the provisions of the
Council Directive 93/42/EEC about medical devices
and fulfills the essential requirements of Annex 1 of
this directive.
It has an internal power source and is an MDD class
IIa device.
• The device fulfills the requirements of standard EN
60601-1 "Medical Electrical Equipment, Part 1: Gen-
eral Requirements for Safety" as well as the interference
protection requirements of standard EN 60601-1-2
"Electromagnetic Compatibility – Medical Electrical
Devices".
• The radio-interference emitted by this device is
within the limits specified in CISPR11/EN 55011,
class B.
• The CE mark covers only the accessories listed in
the chapter "Order Information".
• This manual reflects software version 1.
• This manual is an integral part of the device. It
should always be kept near the device. Close obser-
vance of the information given in the manual is a
prerequisite for proper device performance and cor-
rect operation and ensures patient and operator
safety. Please note that information pertinent to
several chapters is given only once. Therefore,
carefully read the manual once in its entirety.
• The symbol means: Consult accompanying
documents. It indicates points which are of particular
importance in the operation of the device.
• This manual is in conformity with the device specifi-
cations and standards on safety of electromedical
equipment valid at the time of printing. All rights are
reserved for devices, circuits, techniques, software
programs, and names appearing in this manual.
• On request Marquette Hellige will provide a service
manual.
• The Marquette Hellige quality management system
complies with the standards DIN EN ISO 9001 and
EN 46001.
4 TONOPORT V
• The safety information given in this manual is classi-
fied as follows:
Danger
indicates an imminent hazard. If not avoided, the
hazard will result in death or serious injury.
Warning
indicates a hazard. If not avoided, the hazard can
result in death or serious injury.
Caution
indicates a potential hazard. If not avoided, this
hazard may result in minor personal injury and/or
product/property damage.
• To ensure patient safety, the specified measuring ac-
curacy, and interference-free operation, we recom-
mend to use only original Marquette Hellige compo-
nents. The user is responsible for application of ac-
cessories from other manufacturers.
• The warranty does not cover damage resulting from
the use of unsuitable accessories and consumables
from other manufacturers.
• Marquette Hellige is responsible for the effects on
safety, reliability, and performance of the device,
only if
− assembly operations, extensions, readjustments,
modifications, or repairs are carried out by
Marquette Hellige or by persons authorized by
Marquette Hellige,
− the device is used in accordance with the instruc-
tions given in this operator's manual.
• Manufacturer: PAR Medizintechnik GmbH, Berlin
 2000 Marquette Hellige GmbH
Postfach 600265
79032 Freiburg i.Br., Germany
Telephone +49 761 45 43-0
2001589-007 A
 Introduction to TONOPORT V, Safety Information

1 Introduction to TONOPORT V, Safety Information

1.1 TONOPORT V Features

Intended Use Oscillometric Measuring Method

TONOPORT V is a small-size, patient-borne blood-
pressure monitor. It can be used to measure the blood
pressure of adults, children and small children, but it
cannot be used on neonates. Also, it is not suitable for
use in intensive care medicine.
For periods of up to 30 hours it records the patient's
blood pressure at predefined intervals and saves the re-
sults. There is a choice of 3 different measurement pro-
tocols. The stored data can be documented via a printer.
Furthermore, TONOPORT V can be operated in con-
junction with CardioSys and with the CardioSoft DFT
data evaluation software package that comes with
TONOPORT V. CardioSys / CardioSoft supports the
configuration of patient-specific measurement protocols
and on-screen review of the measured results in tabular
and graphic form.
(All instructions given in this manual that describe the
operation in conjunction with CardioSys / CardioSoft
apply to V4.14 and later versions of CardioSys /
CardioSoft.)
The blood pressure is measured by the oscillometric
method. The criteria for this method are the pressure
pulsations superimposed with every systole on the air
pressure in the cuff.
The blood pressure cuff is wrapped around the upper
arm and inflated to a pressure which must be clearly
above the expected systolic pressure. A pressure trans-
ducer measures the cuff pressure as well as the superim-
posed pressure pulsations. During blood pressure meas-
urements the cuff must be level with the heart. If this is
not ensured, the hydrostatic pressure of the liquid col-
umn in the blood vessels will falsify the measurement
results.
When the patient is sitting or standing during measure-
ments, the cuff is automatically at the correct level.
131

76
Biocompatibility
The parts of the product described in this operator
manual, including all accessories, that come in
contact with the patient during the intended use,
fulfill the biocompatibility requirements of the ap-
plicable standards. If you have questions in this
matter, please contact Marquette Hellige GmbH or
Figure 1-1. Waveform representing the cuff pressure
its representatives.
decrease during a measurement;
systolic pressure at 131 mmHg
diastolic pressure at 76 mmHg

1.2 Functional Description

The TONOPORT V BP monitor houses the blood-

pressure measuring system and a microprocessor for
system control and data processing. The BP monitor is
powered from two AA size batteries (alkaline batteries
are supplied with the device, rechargeable NiMH bat-
teries are available as optional accessories).

2001589-007 A TONOPORT V 5
 Introduction to TONOPORT V, Safety Information

1.3 Safety Information

Danger
− The devices are not designed for use in areas
where an explosion hazard may occur. An ex-
plosion hazard may result from the use of
flammable anesthetics, skin cleansing agents
and disinfectants.
− Devices may be connected to other devices or
to parts of systems only when it has been made
certain that there is no danger to the patient,
the operators, or the environment as a result.
In those instances where there is any element
of doubt concerning the safety of connected
devices, the user must contact the manufactur-
ers concerned or other informed experts as to
whether there is any possible danger to the pa-
tient, the operator, or the environment as a re-
sult of the proposed combination of devices.
Compliance with the IEC standard 60601-1-1
must be ensured in each case.
TONOPORT V may be connected to Cardio-
Sys, to a PC with the CardioSoft program, and
to a printer. While connected to any of these
devices, TONOPORT V must be disconnected
from the patient.
− Chemicals required for the maintenance of the
device for instance, must under all circum-
stances be stored, prepared, and kept at hand in
their specific containers. Failure to observe this
instruction may result in severe consequences
for the patient.
− Liquids must not be allowed to enter the de-
vices. Devices into which liquids have pene-
trated must be immediately cleaned and
checked by a service technician, before they
can be reused.
− Before cleaning TONOPORT V BP monitors,
disconnect them from other devices (Cardio-
Sys, PC, printer).
− Dispose of the packaging material, observing
the applicable waste-control regulations. Keep
the packaging material out of children's reach.
Warning
− Magnetic and electrical fields are capable of
interfering with the proper performance of the
device. For this reason make sure that all ex-
ternal devices operated in the vicinity of the de-
fibrillator comply with the relevant EMC re-
quirements. X-ray equipment, MRI devices and
radio systems are a possible source of interfer-
ence as they may emit higher levels of electro-
magnetic radiation.
− Only use accessories the application of which
has been approved by Marquette Hellige. The
user is responsible for application of accesso-
ries from other manufacturers.
Caution
− Before using the device, the operator must as-
certain that it is in correct working order and
operating condition.
− The operator must be trained in the use of the
device.
− Medical electrical devices must only be han-
dled by persons who are trained in the use of
such equipment and are capable of applying
them properly.
− Check the device performance at regular inter-
vals (once a month).
The technical safety inspections must be car-
ried out on an annual basis, the inspections of
the measuring system every two years (see
chapter 7 "Cleaning, Maintenance").
− There are no user-replaceable components in-
side the device. Do not open the device housing
(notify service).

6 TONOPORT V 2001589-007 A
 Introduction to TONOPORT V, Safety Information

Literature

Medical Device Directive of August 2, 1994

EN 60601-1: 1990 + A 1: 1993 + A 2: 1995

Medical electrical equipment. General requirements for
safety.

EN 60601-1-1: 9/1994 + A1: General requirements for

safety. Requirements for the safety of medical electrical
systems.

IEC-Publication 513/1994: Fundamental aspects of

safety standards for medical equipment.

2001589-007 A TONOPORT V 7
 Controls and Indicators

2 Controls and Indicators

1 Connection for the blood pressure cuff

INFO
2 Button to display the most recent parameter
1 3
readings. Readings appear in the following order:
2
- systolic value "S/mmHg"
4 - diastolic value "D/mmHg"
N
B
P

S TO
TA P
S

R
T

- pulse rate "HR/min-1".

IN
F
O

The same button is used

T
O
N

- to switch from the day to the night phase

O
P
O
R

S mm in
/m
T

D /m

m Hg 1
/

H
H

g
R

(chapter 4, section "Switching Manually

-

Between Day and Night Phase) and

5 -to program the BP monitor (chapter 3 "Setting
!

6 Up the TONOPORT V BP Monitor")

START
3 Button STOP to start and stop a measurement, or to
PC/Printer

confirm entries

4 Liquid crystal display (LCD)

12/2001
PAR

5 Lid covering battery compartment

6 PC / printer port
N
B
P

S TO
TA P

7 Batteries
S

R
T
IN
F
O

8 Power switch
T
O
N

9 Calibration mark
O
P
O
R

S mm in
/m
T

D /m

m Hg 1
/

H
H

g
R

8 Explanation of Signs and Symbols

off
0
Symbols used on the BP monitor
7
!

on
I

Attention, refer to Operator's Manual

Data input / output

PC/Printer

9
Type B signal input (defibrillator-proof)
12/2001
PAR

Symbols used on the display

M blinks with each detected oscillation

is continuously lit to indicate that BP data is
stored in memory
Figure 2-1. Controls and indicators of the
blinks when batteries are almost discharged,
TONOPORT V blood pressure monitor
is continuously displayed when batteries are dis-
charged and BP measurements cannot be taken
day period selected
night period selected

8 TONOPORT V 2001589-007 A
 Setting Up the TONOPORT V BP Monitor

3 Setting Up the TONOPORT V BP Monitor

Some Basic Facts on Battery Power Inserting Batteries

TONOPORT V is either powered from two alkaline • Hold the TONOPORT V BP monitor in your hands
batteries, or from two rechargeable Nickel Metal Hy- as shown in Figure 3-1 and slide the lid of the battery
dride (NiMH) batteries which are available as an option. compartment open (approx. 1 cm).
The BP monitor must be set to the power source used
It is not possible to open the lid more than approx. 1 cm;
(see section "Inserting Batteries" below). The BP
this is just enough to permit access to the power switch
monitor also contains a Lithium cell which powers the
under the lid. When replacing batteries, lift the lid up-
clock and which can only be replaced by a service tech-
ward to remove it.
nician. The Lithium cell has a minimum service life of
10 years. • Place the two batteries into the compartment as indi-
cated by the symbols.
The capacity of two new alkaline batteries or of two
fully charged NiMH batteries is sufficient for a mini- Selecting the Energy Source
mum of 30 hours of operation or 200 measurements.
• Turn on the BP monitor (the power switch is located
The capacity of rechargeable batteries decreases with
in the battery compartment).
age. If the capacity of fully charged batteries drops con-
siderably below 24 hours of operation, the batteries have • Wait until the display shows the time.

• Press
INFO
to be replaced. six times: The display shows "H 6".

• Press START
STOP : The display will show "bbbb" when the
Caution
BP monitor is set up for disposable alkaline batter-
− Use only the alkaline batteries or rechargeable
NiMH batteries (1.5 Ah) supplied by Marquette ies. If the monitor is set up for rechargeable NiMH
Hellige. batteries which are available as optional accessories,
− Recharge the NiMH batteries immediately af-
the display will read "AAAA".
ter use and do not leave batteries uncharged.
− Use a commercially available charging unit • Confirm the displayed information with START
STOP or
that is capable of charging the Marquette Hel- change the selection with
INFO
and confirm the new
lige supplied AA size, 1.5 Ah NiMH batteries. START
selection with STOP .

• Next the BP monitor will briefly display the capacity

of the inserted batteries. "b 50" means the alkaline
batteries are half depleted (50% capacity), "A 100"
means the NiHM batteries are fully charged (100%
capacity).

• Place the lid on the battery compartment and slide it

towards the back to close the compartment.

Note
The energy source needs to be selected only when
the BP monitor is put into service for the first time
or when you change from disposable to recharge-
able batteries and vice versa.
Figure 3-1. Opening the battery compartment

2001589-007 A TONOPORT V 9
 Setting Up the TONOPORT V BP Monitor
Charging NiMH Batteries
If TONOPORT V is operated with rechargeable NiHM
batteries, they should be recharged immediately after
each use (24 hours). Any commercially available
charging unit suitable for the Marquette Hellige supplied
AA size, 1.5 Ah NiMH batteries can be used.
Caution
Observe the user instructions that come with your
charging unit.
To extend the useful life of NiMH batteries, we recom-
mend to run a full discharge/charge cycle once a month.
Please refer to the user manual supplied with your
charging unit for instructions.
10 TONOPORT V
Performance Check
When turned on, TONOPORT V runs a self-test which
includes all symbols and segments on the LCD (Figure
3-2). Then the BP monitor checks the batteries and indi-
cates the remaining capacity. When the display indicates
"b 50", this means the alkaline batteries are half de-
pleted (50% capacity), "A 100" means the NiHM bat-
teries are fully charged (100% capacity).
The minimum battery capacity for a 24-hour measure-
ment is 90%. If the capacity is below 90%, insert either
fresh or fully charged batteries.
BP monitors which have passed the self-test and com-
pleted the battery test will indicate the following infor-
mation
− the time of day,
− the measuring phase (day / night ), and
− whether or not BP data are stored in the monitor (M)
(Figure 3-3).
Figure 3-2. Test display on the LCD
Figure 3-3. Example of a display when the BP monitor
has passed the self-test
(M = BP data in memory,
= measuring phase: day)
Before using TONOPORT V on a patient
− delete old data stored in memory,
− check time and date and correct, if necessary,
− select the appropriate measurement protocol, if nec-
essary.
2001589-007 A
 Setting Up the TONOPORT V BP Monitor

INFO
Functions of the Button Time and Date
The different setup functions, such as deleting data, set- Usually the BP monitors are set to the correct time and
INFO
ting date and time, are activated with the button. date before delivery. The internal clock is powered from
a Lithium cell with a minimum service life of 10 years.
INFO
For this reason, it is only necessary to correct the time
button Message on Function
when changing between Daylight Saving Time and
display
Standard Time.
Push once H1 delete data If using TONOPORT V in conjunction with CardioSys
or CardioSoft, it is possible to adapt the time to the sys-
Push twice H2 adjust date and time
tem time when TONOPORT V is connected to Cardio-
Push 3 times H 3 select measurement Sys or to the PC.
protocol
Setting Time and Date
Push 4 times H 4 calibration mode

Push 5 times H 5 display software ver-
sion
Push 6 times H 6 select energy source
• Briefly switch the TONOPORT V BP monitor off,
then switch it on again and wait until the time of day
displays.
• Press
INFO
twice: the display indicates "H 2".

Deleting BP Data • Press START

STOP . The year will be displayed, e.g. 1999.

The "M" on the LCD indicates that BP data is stored in • If the displayed year is correct, press START
STOP or correct
memory. If you intend to use this data for evaluation, re- INFO
the year with and confirm the new value with
fer to chapter 5 "Data Output" for instructions. If you do START
STOP .
not need the data any more, you can delete it as follows:

• Briefly switch the TONOPORT V BP monitor off, • The month will be displayed, e.g. 09.
then switch it on again and wait until the time of day
• If the displayed month is correct, press START
STOP or cor-
displays. INFO
rect the month with and confirm the new value
• Press
INFO
: the display indicates "H 1". with START
STOP .

• Press START
STOP : the display indicates "LLLL". • In the same manner, correct day, hours and minutes.

• Press START
STOP again to delete the data. The display indi- • In the end, the time of day will be displayed again.
cates "0000", then it shows the time of day (if you do
not intend to delete the data, turn off the patient
START
monitor instead of pressing STOP ).

The CardioSys system and the CardioSoft program have

a special function which allows you to delete the
TONOPORT data.

2001589-007 A TONOPORT V 11
 Setting Up the TONOPORT V BP Monitor

Measurement Protocols

In conjunction with CardioSys / CardioSoft, patient-

specific measurement protocols can be configured and
the maximum inflation pressure can be adjusted in the
range between 200 mmHg and 280 mmHg (see also
chapter 5 "Data Output" and the CardioSys / CardioSoft
Operator's Manual).

If you do not have this option, you can choose among

three preconfigured protocols.

Protocol Day Phase Night Phase

(7 a.m. to 10 p.m.) (10 p.m. to 7 a.m.)

P1 every 15 minutes every 30 minutes

P2 every 20 minutes every 40 minutes

P3 every 30 minutes every 60 minutes

Max. inflation pressure: day phase – 250 mmHg

night phase – 220 mmHg

Selecting a Measurement Protocol.

• Briefly switch the TONOPORT V BP monitor off,

then switch it on again and wait until the time of day
displays.

• Press
INFO
three times: the display indicates "H 3".

• Press START
STOP : the display indicates "LLLL" (Selecting
a protocol automatically deletes old data. If you do
not want to delete the data, turn off the BP monitor.)

• Press START
STOP : the display indicates "P1" (protocol 1).

• Either select protocol 2 or 3 with

INFO
or

• Confirm the selected protocol with START

STOP .

12 TONOPORT V 2001589-007 A
 Application

4 Application

Danger

Disconnect TONOPORT V from any other device

(CardioSys, PC, printer) before connecting it to
the patient.

• Always insert two new Alkaline batteries or two

fully charged NiMH batteries into the BP monitor
before starting a measurement.

• Check that old data has been deleted (page 11 "De-

leting BP Data").

• First of all, select the appropriate cuff size (refer to

cuff label). When the cuff is too small the BP val-
ues will be overrated, when it is too big, the
measured values will be too low.

Figure 4-1. Applying the cuff Caution

− Use only the cuffs listed in chapter 10 "Order
Information".
− Replace cuffs at regular intervals. Damaged
Velcro fasteners may prevent correct BP meas-
urements.

• Place the cuff on that arm of the patient which is

used less frequently during normal daily activities:
on adults about 2 fingers' breadth above the bend of
the elbow, on children a little closer. Bending the
arm must not alter the cuff level.

Index
Index • Verify that
Index
- the cuff tubing points upward towards the shoul-
der (Figure 4-1),

- the side with the "Patient" label is on the skin,

- the arrow is located above the brachial or femoral

Figure 4-2. Applying the cuff artery,

- the white index line at the end of the cuff is lo-

cated between the two index lines when you
close the cuff (Figure 4-2, if this is not the case,
select another cuff size),

- the cuff fits snugly around the arm, but does not
occlude blood vessels.

2001589-007 A TONOPORT V 13
 Application

Initiating a Trial Measurement Patient Information

• Turn on TONOPORT V and place it in the carrying

Advise your patient

pouch. There is an aperture in the pouch to accom- − not to move while a measurement is being taken, be-
modate the cuff connection tube. cause motion artifact may lead to erroneous read-

• Attach the pouch to the patient (shoulder strap, belt). ings,

For reasons of hygiene, it is not advised to carry the
pouch on the bare skin.
• Guide the pressure hose around the patient's neck as
a strain relief and connect it to the BP monitor. Ad-
vise the patient to avoid kinking the tubing during
the procedure.
• Check that the time of day is displayed.
If the patient monitor contains BP data, the letter
"M" will appear on the display when you turn the
− that at night it is recommended to place the
TONOPORT V BP monitor on the night stand,
− how to switch the monitor manually to the day or
night phase (see below),
− that events deemed important should be noted down
in a little diary and that intermediate measurements,
if necessary, can be initiated with the START
STOP button,
− that the measurement can be aborted at any time with
the START
button (the cuff will be deflated),
STOP

monitor on. If you still try to initiate a measurement, − not to open the battery compartment.
the message "LLLL" prompts you to clear the mem-
START
ory. Press STOP twice to delete the stored data. If you
Warning
do not want to delete the BP data, do not push the
START
Instruct your patient
STOP button, and turn the monitor off instead.
START
– to terminate the measurement with the
•
STOP
To prevent erroneous measurements, ensure that the
button, whenever the cuff is not deflated within
patient does not move during the trial measurement.
about 2 minutes,
The patient may stand or sit.

• Press START
STOP to initiate the first measurement.
– to remove the cuff if it is not deflated after ac-
START
tivation of the STOP button. In this case, the
After a short waiting period, the monitor starts inflating
the cuff. When the inflation pressure has been reached, cuff tubing may be kinked. The cuff must be
the cuff is gradually deflated. The cuff pressure is con- reapplied as described earlier before additional
tinuously indicated and the letter M displays with each measurements can be taken.
detected oscillation. At the end of the measurement, the
following information appears in that order

− the systolic reading (S/mmHg),

− the diastolic reading (D/mmHg), and
− the pulse rate (HR/min-1).
If the error code E 29 (insufficient number of oscilla-
tions detected) appears after the measurement, tighten
START
the cuff a little and press STOP again (see also chapter 6
"Error Codes").

If the trial measurement has been successfully com-

pleted, the monitor is ready to take automatic blood-
pressure measurements.

14 TONOPORT V 2001589-007 A
 Application

General Information on Ambulatory BP Measure- Switching Manually Between Day and Night Phase
ments
In the three measurement protocols, the day and night
These are the buttons on the monitor which are used in phases last from 7 a.m. to 10 p.m. and from 10 p.m. to 7
the course of an ambulatory BP measurement: a.m., respectively; on the display they are represented by
START
starts and stops a measurement the symbols (day) and (night).
STOP

INFO
Patients whose day and night phases are different from
calls up the values of the last measurement or INFO
these predefined periods can press the button twice
the last error code, toggles between day and
to change from one phase to the other.
night phase (see below)
If the measurement protocol used was programmed with
For the first measurement, the cuff is inflated to a pres- INFO
CardioSys / CardioSoft, pressing the button twice
sure of 170 mmHg (initial pressure). For subsequent
will have the following effect (with CardioSys / Cardio-
measurements, the monitor inflates the cuff to a pressure
which is 30 mmHg above the systolic value of the previ- Soft V4.14 and later):
ous measurement (minimum inflation pressure: 1 BP period: beginning of night or day phase is anno-
120 mmHg). tated in the report.
2 BP periods: manual switchover from period 1 to pe-
If the measuring value is above the inflation pressure,
riod 2 and vice versa.
the monitor will increase the cuff pressure another
3 BP periods or more: manual switchover is not possi-
50 mmHg.
ble.
A manual measurement can be initiated at any time be-
tween the automatic measurements. Manual measure-
ments are identified with the symbol + in the tabular BP
data.

The monitor will repeat an unsuccessful measurement

after 2 minutes. An error code referring to this situation
is generated only if three consecutive measurements
were unsuccessful.

Error codes E02 (battery depleted), E06 (inflation time

over) and E08 (200 pressure measurements taken) do
not lead to a second measurement. After the error code
E06, the next measurement will take place in the se-
lected rhythm.

After the error codes E02 and E08, the monitor enters a
power saving mode to prevent over discharging of the
rechargeable batteries. This mode can only be termi-
nated by turning the monitor off and on again.

2001589-007 A TONOPORT V 15

5 Data Output
Danger
Disconnect TONOPORT V from the patient, be-
fore connecting it to any peripheral device (Car-
dioSys, PC, printer).
Note
If you do not click the "Download data" button to
initiate data transfer within 10 minutes of con-
necting the TONOPORT V monitor to Cardio-
Sys / CardioSoft, TONOPORT V will enter the
power save mode and the message "Error initial-
izing interface" appears.
Follow these steps in this situation:
- turn the TONOPORT V off and on again
- reactivate the ambulatory blood pressure
mode
- initiate data transfer within 10 minutes by
clicking the "Download data" button.
Note
TONOPORT V was designed for use with Cardio-
Sys / CardioSoft V4.14 and later versions. When
operating TONOPORT V in conjunction with
older version of CardioSys / CardioSoft, wait
about 10 seconds before clicking the "Download
data" button. Otherwise the message "Difference
between number of expected and transferred
data!" may appear.
When you see the message, acknowledge it with
"OK" and click "Download data" again.
16
Data Output
Generating the Procedure Report with CardioSys /
CardioSoft
When operating TONOPORT V in conjunction with
CardioSys / CardioSoft, the procedure data can be re-
viewed on screen in tabular and graphic form (see Car-
dioSys / CardioSoft Operator's Manual).
” Turn the TONOPORT V monitor off.
” Using the supplied cable, connect the TONOPORT
V monitor to the PC (Figure 5-1).
” Turn the TONOPORT V monitor on.
The determination of the statistics intervals depends on
the number of configured BP periods (CardioSys / Car-
dioSoft V4.14 and later):
1 BP period:
The "Statistics Intervals" button on the "Test Summary"
screen is disabled. BP data for the night phase are avail-
able only when the patient has manually switched to the
night phase. Otherwise there is no night phase and no
wake-up time. The wake-up time begins 2 hours before
the day time.
Measurements taken during the night phase are identi-
fied with an asterisk * in the tabular BP data and with a
short dash above the time scale in the graphic data.
Manual measurements are identified with the symbol +
in the tabular BP data.
2 BP periods:
As above. If the patient does not switch manually to the
night phase, the BP monitor will automatically switch to
the night phase (2nd BP period).
3 or 4 BP periods:
The patient cannot switch manually to the next period.
Nocturnal data are not available. The day and night
phases can be defined as usual in the Statistics Intervals
dialog. There is no special identification for measure-
ments taken during the night phase or for manual meas-
urements.
TONOPORT V 2001589-007 A
 Data Output

Direct Data Output to Printer

If you do not operate the BP monitor in conjunction

N
B
P
with CardioSys / CardioSoft, the ambulatory blood-

S TO
TA P
S

R
T
IN
F
O
pressure report can be generated on a 9-needle dot-

T
matrix printer with serial interface (EPSON LX-300).
O
N
O
P
O
R

S mm in
/m
T

D /m

m Hg 1
/
Before printing the report, set up the printer as follows

H
H

g
R

-
(observe the printer's user manual):
− character table PC 437

!
− baud rate 9600
− parity none
PC/Printer

− word length 8 bit

12/2001

•
PAR

Turn off TONOPORT V.

• Using the cable supplied with the printer, connect
TONOPORT V to the printer (Figure 5-1).
Figure 5-1. Connection for printer or PC cable • Turn on the printer.
• Turn on TONOPORT V.
The display indicates "0000".
• Press START
STOP to initiate the report printout.
Refer to the Appendix for a sample printout.

2001589-007 A TONOPORT V 17
 Error Codes

6 Error Codes

E 02 Batteries depleted. Code appears when the bat- E 15 Motion artifact during diastole detection.
tery capacity is insufficient for new BP meas- E 17 Internal hardware error (notify Service).
urements. The recorder differentiates between
E 18 Systolic reading outside measuring range.
two states: the memory has just been cleared
E 19 Diastolic reading outside measuring range.
(i.e., the battery test is performed with a higher
(These codes are displayed when the systolic
drain to ensure that fresh batteries will be in-
and diastolic values are outside the range in
serted at the beginning of the measurement) or
which oscillations have been detected.)
measurements have already been taken.

E 03 Measurement time over. Code is displayed
when a measurement is not completed within 60
seconds (excluding cuff inflation time).
E 06 Inflation time over. The maximum inflation
time of 60 seconds has elapsed. This condition
indicates a leak in the cuff or tubing, or a de-
fective gasket.
E 07 This code appears
– when the monitor could not determine a sys-
tolic value although the cuff pressure was al-
ready increased twice
– when the current cuff pressure would exceed
the maximum permitted inflation pressure of
280 mmHg
The monitor will not inflate the cuff to a pres-
sure which is above the selected maximum
pressure, and waits until the next measurement
is due.
E 21 Difference between systolic and diastolic pres-
sure too small (10 mmHg or less).
E 22 Motion artifact during systole detection.
E 24 No systole detected in the provided time frame.
E 26 Systolic reading below measuring range.
E 27 Systolic reading above measuring range.
E 29 Insufficient number of oscillations detected: For
a correct measurement, the system must detect
at least 8 oscillations. Tighten the cuff so that
one finger, but not two, can be inserted between
the patient's arm and the cuff. At the same time
the device switches to a deflation rate of
4 mmHg/s. When it detects more than 13 oscil-
lations later on, the rate changes to 6 mmHg/s.

E 08 200 pressure measurements taken; storage ca-

pacity exhausted.

E 14 Diastolic reading below 40 mmHg. Code ap-

pears when the cuff pressure has dropped to
40 mmHg and no diastolic pressure could be
identified (TONOPORT V does not measure
diastolic pressures below 40 mmHg).

18 TONOPORT V 2001589-007 A
 Cleaning, Maintenance
7 Cleaning, Maintenance
7.1 Cleaning, Disinfection
Monitor Surface
Danger
Before cleaning TONOPORT V, disconnect it
from the PC or printer.
” Turn off TONOPORT V.
” Wipe the monitor clean with a moist cloth. Do not
let liquid enter the monitor.
All hospital-grade cleaning agents and disinfectants
can be used.
Caution
Do not disinfect the device surface with phenol-
based disinfectants or peroxide compounds.
Danger
Devices into which liquids have penetrated must
be immediately cleaned and checked by a service
technician, before they can be reused.
Cuffs
” Use a moist cloth to wipe clean slightly soiled cuffs.
” Remove heavy soiling by washing the cuff with
soap water or a suitable cleaning agent that contains
a disinfectant (do not machine-wash). Ensure that
no liquid penetrates into the cuff bladder or the
pressure hose (for this reason, remove the bladder
from the cuff before cleaning it).
” After cleaning, rinse the cuff thoroughly with water
and let it dry at room temperature for about 15
hours.
2001589-007 A TONOPORT V
− The cuffs can be disinfected with isopropyl alcohol
70%, ethanol 70%, Microzid, Buraton liquid, Spori-
cidin or Cidex. After disinfection, rinse the cuff
thoroughly with tap water and air-dry.
− The cuffs may be gas-sterilized with ethylene oxide.
Strictly observe the manufacturer's instructions.
Cables
” Disconnect cables from the device before cleaning
them.
” Use a cloth moistened with soap water to wipe the
cables clean. Do not immerse the cable in liquid.
7.2 Maintenance
Checks before each use
” Before each use visually check the device and the
cables for signs of mechanical damage.
If you detect damages or impaired functions which may
result in a hazard to the patient or the operator, the de-
vice must be repaired before it can be used again.
Technical Safety Inspections
For safety, the devices require regular maintenance. To
ensure functional and operational safety of the
TONOPORT V, Technical Safety Inspections should be
carried out on an annual basis.
These checks should be performed by persons with ade-
quate training and experience.
The checks can be carried out by Marquette Hellige
within the framework of a service contract.
The nature and scope of these checks are explained in
the corresponding sections of the Service Manual.
The device does not require any other maintenance.
19
 Cleaning, Maintenance

Technical Inspections of the Measuring Sys- Calibration Mode

tem (e.g. to check the pneumatic system for leaks)

The non-invasive pressure measurement system must be ” Connect a rubber bulb between pressure hose and
inspected every 2 years. cuff, using a T-adapter.

These checks should be performed by persons with ade- ” Roll up cuff tight.
quate training and experience. ” Switch off device and switch it on again after a few
The checks can be carried out by Marquette Hellige seconds.
within the framework of a service contract. ” Wait until the display shows the time.
The nature and scope of these checks are explained in INFO
” Press the button 4 times: the display indicates
the corresponding sections of the Service Manual.
"H 4".

Caution ” Press the START

At the end of their service life, the device described
in this manual and its accessories must be dis-
posed of in compliance with the applicable local
waste control regulations. If you have questions re-
garding the disposal of the product or of the acces-
sories, please contact Marquette Hellige GmbH or
its representatives.
STOP button: the display indicates an inter-
nal value which must be between 25 and 100. If the
displayed value is outside this range, the
TONOPORT V monitor must be returned to
Marquette Hellige for repair.
” Press the START
STOP button again: display indicates "0"
(the display now indicates the pressure in mmHg).

” Generate a test pressure of 200 mmHg and measure

the pressure decrease after waiting at least 30 sec-
onds. (Pressure decreases between 3 and 5 mmHg
are typical; if the pressure decrease exceeds
10 mmHg, there must be a leak and the system
needs to be repaired.)

” Press START
STOP to exit the calibration mode.

Viewing the Software Version and System

Language
” Switch on device and wait for display to indicate
the time.
INFO
” Press 5 times: the display indicates "H 5".

” START
STOP : the software version will be indicated, e.g.
"10:01" = software version 1.0, German
"10:02" = software version 1.0, English
"10:03" = software version 1.0, French
"10:04" = software version 1.0, Italian
"10:05" = software version 1.0, Spanish

” Press START
STOP to end the display.

20 TONOPORT V 2001589-007 A
 Technical Specifications

8 Technical Specifications

Microprocessor Environment

− P80C558EFB Operation

Storage Capacity
− temperature +10 to + 40 oC / 32 to 104 °F
− 128 x 8 bit ( = 1 Megabit) EEPROM − relative humidity 30 to 75 %, no condensation
− atmospheric pressure 700 to 1060 hPa
− 512 x 8 bit ( = 4 Megabit) EEPROM
Transport and storage
Measuring Range
− temperature -10 to 70 °C / 14 to 158 °F
− systolic pressure 60 to 260 mmHg
− relative humidity 10 to 90 %, no condensation
− diastolic pressure 40 to 220 mmHg − atmospheric pressure 500 to 1060 hPa

− mean pressure: 50 to 260 mmHg Dimensions and Weight

− pulse rate (HR): 35 to 240 min-1 − height 99 mm

− width 80 mm
Acquisition Period
− depth 27 mm
− up to 30 hours or 200 measurements − weight 215 g, incl. batteries

Battery

− 2 AA size alkaline batteries

Max. Cuff Pressure

− 300 mmHg

Measuring Method

− oscillometric

2001589-007 A TONOPORT V 21
 Order Information

9 Order Information

Subject to change. Always refer to latest list of accesso- Accessories

ries.

2001762-002 TONOPORT V Ambulatory Blood Pres- 2001589-007 TONOPORT V Operator's Manual

sure System
• TONOPORT V Blood-Pressure
Monitor
• TONOPORT V – PC connection cable
• 4 (four) Alkaline batteries
• Carrying pouch
• Belt for carrying pouch
• Blood-pressure cuff for adults, stan-
dard, width 14 cm, for circumference
between 24 and 32 cm, plug-in con-
nection
• TONOPORT V Operator's Manual
• CardioSoft DFT data analysis program
(Windows 9x, Windows NT)
• CardioSoft Operator's Manual
2001589-014 Rechargeable NiMH battery (monitor
requires 2)
737 000 08 Alkaline battery, 1.5 V (monitor requires
2)
2001589-015 Carrying pouch
2001589-016 Belt for carrying pouch
2001589-011 TONOPORT V – PC connection cable
2001589-018 Blood-pressure cuff for adults, standard,
width 14 cm, for circumference between
24 and 32 cm, plug-in connection
2001589-017 Blood-pressure cuff for adults, small,
width 10.5 cm, for circumference be-
tween 17 and 26 cm, plug-in connection
2001589-019 Blood-pressure cuff for adults, large,
width 17.3 cm, for circumference be-
tween 32 and 42 cm, plug-in connection
701 217 18 Printer, EPSON LX-300 (incl. connec-
tion cable)
2001589-012 TONOPORT V – printer connection
cable
250 296 17 CardioSoft DFT data analysis pro-
gram (Windows 9x, Windows NT)
227 497 02 CardioSoft Operator's Manual

22 TONOPORT V 2001589-007 A
 EU Declaration of Conformity

2001589-007 A TONOPORT V 23
 Sample Report

24 TONOPORT V 2001589-007 A
 Sample Report

2001589-007 A TONOPORT V 25
 Sample Report

26 TONOPORT V 2001589-007 A
 Sample Report

2001589-007 A TONOPORT V 27
 Index

Index

A L
Accessories 22 Literature 7

B M
Batteries, disposable 9 Maintenance 19
Batteries, recharge 10 MDD 4
Batteries, rechargeable 9 Measurement protocol, selection of 12
Biocompatibility 5 Measuring system, inspection of 20
Blood pressure cuff 5
BP monitor, connect to patient 13
N
C Night phase 15

Calibration mode 20
Caution, definition 4
O
Cautions 6 Operator's manual 4
CE mark 4 Order information 22
Charge batteries 10 Oscillometric measuring method 5
Checks before each use 19
Cleaning the cables 19
Cleaning the cuffs 19 P
Cleaning the monitor surface 19 Part numbers 22
Clear memory 11 Patient, connect BP monitor to 13
Controls 8 Performance check 10
Cuff application 13 Power supply 9
Cuff size 13 Printer, report generation 16
Protocol, selection of 12
D
Danger, definition 4 R
Dangers 6 Report generation via printer 16
Data output to printer 16 Report generation with CardioSys/CardioSoft 16
Date adjustment 11 Revision code 3
Date and time of TONOPORT V 11 Revision history 3
Day and night phases 15
Delete BP data 11
Device features 5 S
Diary 14
Safety information 6
Dimensions 21
Self-test 10
Disposal of the device 20
Setup 9
Software version 4
E Software version, view 20
Specifications 21
EMC requirements 6 Symbols, explanation 8
Energy source, select 9
Environment 21
EU Declaration of conformity 23 T
Explosion hazard 6
Technical inspections of the measuring system 20
Technical safety inspections 19
G Technical Specifications 21
Time, setting the clock 11
General information 4 Trial measurement 14

I W
Indicators 8 Warning, definition 4
Inserting disposable batteries 9 Warnings 6
Inserting rechargeable batteries 9 Warranty 4
Interfacing with other devices 6 Weight 21

28 TONOPORT V 2001589-007 A