GE TONOPORT V User manual

GE Healthcare
TONOPORT V
Ambulatory Blood Pressure System
Firmware Version 2.2
Operator’s Manual
2001589-085 ENG Revision G

2 TONOPORT V 2001589-085 Revision G
Note
The information in this manual only applies to TONOPORT V, firmware version 2.2. It does not apply to earlier
firmware versions.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
CASE™ is a trademark owned by GE Medical Systems Information Technologies GmbH, a General Electric
Company going to market as GE Healthcare.
© 2009–2022 General Electric Company. All rights reserved.

Contents
2001589-085 Revision G TONOPORT V 3
1 Application, Safety Information 6
2 Controls and Indicators 10
3 Setup 12
4 Application 17
5 Data Output 21
6 Error Codes 22
7 Software Installation 23
8 Cleaning, Maintenance, Disposal 25
9 Technical Specifications 27
10 Order Information 28
11 Appendix - Electromagnetic Compatibility (EMC) 29
Revision History
This manual is subject to the GE Healthcare change order service. The revision code, a letter that follows the
document part number, changes with every update of the manual.
Part No./Revision Date Comment
2001589-085 Revision A 2009-05 Initial release
2001589-085 Revision B 2010-04 General Information: modifications in 3rd
paragraph
Section 1.3: additional information concerning the
ingress of liquids
Chapter 2: four symbols added
Chapter 3: additional information concerning
alternative charger
2001589-085 Revision C 2011-10-31 CardioSys was removed globally
Chapters 1.1, 5 and 7: interface restrictions for
CASE/CardioSoft were added
Chapter 2: relevant battery charger symbols were
added
Chapter 7: CardioSoft version 6.7 for Windows 7
and reference to the “CASE-CS” folder were added
Chapter 9: measuring range for mean pressure was
corrected to '50 to 250 mmHg'
2001589-085 Revision D 2014-01-31 Changes on pages 4, 5, 11, 12, 23, and 24.
2001589-085 Revision E 2015-05-07 Changes on pages 8, 17, and 27.
2001589-085 Revision F 2016-07-12 Changes on pages 4, 11, and 28.
2001589-085 Revision G 2022-09-05
Change of the Manufacturer's and Distributor's address,
Update of Section 4

General Information
4 TONOPORT V 2001589-085 Revision G
General Information
The product TONOPORT V bears the CE marking
CE 0482 (notified body MEDCERT GmbH)
indicating its compliance with the provisions of the
Council Directive 93/42/EEC about medical devices
(including amendment 2007/47/EC) and fulfills the
essential requirements of Annex I of this directive. It
has an internal power source and is an MDD class
IIa device. The device fulfills the requirements of the
Directive 2011/65/EU of the European Parliament
and of the Council.
It has a type BF applied part.
The product fulfills the requirements of the standard
EN/IEC 60601-1 "Medical Electrical Equipment, Part
1: General Requirements for Basic Safety and
Essential Performance" as well as the electromagnetic
immunity requirements of the standard EN/IEC
60601-1-2 "Medical electrical equipment – Collateral
standard: Electromagnetic compatibility –
Requirements and tests" and applicable amendments.
The radio-interference emitted by this product is
within the limits specified in CISPR11/EN 55011,
class B.
The CE marking covers only the accessories listed in
the "Order Information" chapter.
This manual is an integral part of the equipment. It
should be available to the equipment operator at all
times. Close observance of the information given in
the manual is a prerequisite for proper equipment
performance and correct 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 equipment.
This manual reflects the equipment specifications and
applicable safety standards valid at the time of
printing. All rights are reserved for devices, circuits,
techniques, software programs, and names appearing
in this manual.
On request GE Healthcare will provide a detailed
Service Manual.
The safety information given in this manual is
classified as follows:
To ensure patient safety and interference-free
operation and to guarantee the specified measuring
accuracy, we recommend only original equipment
accessories as available through GE Healthcare
distribution. The user is responsible for the
application of accessories from other manufacturers.
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, the
hazard may result in minor injury and/or product/
property damage.

General Information
2001589-085 Revision G TONOPORT V 5
PAR Medizintechnik GmbH & Co. KG
Rigistr. 11
12277 Berlin
Germany
Tel. [phone]
Distributor:
GE Medical Systems
Information Technologies, Inc.
9900 Innovation Drive
Wauwatosa, WI 53226 USA
The country of manufacture appears on the device label.

Application, Safety Information
6 TONOPORT V 2001589-085 Revision G
1 Application, Safety Information
1.1 Application
Intended Use
TONOPORT V is a small-size, patient-borne blood
pressure monitor for ambulatory, non-invasive
measurement of the patient’s blood pressure. If the blood
pressure cuffs listed in chapter 10 "Order Information" fit
the patient, it can be used on adults, children, and small
children. TONOPORT V is not suitable for blood
pressure measurements in neonates. Also it is not
suitable for use in intensive-care medicine.
For periods of up to 30 hours, TONOPORT V records the
patient's blood pressure at selectable intervals and saves the
results. There is a choice of three different measurement
protocols.
Oscillometric Measuring Method
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 transducer mea-
sures the cuff pressure as well as the superimposed pres-
sure pulsations. During blood pressure measurements the
cuff must be level with the heart. If this is not ensured,
the hydrostatic pressure of the liquid column in the blood
vessels will lead to incorrect results.
When the patient is sitting or standing during
measurements, the cuff is automatically at the correct
level.
Fig. 1-1 Waveform representing the pressure decrease
in the cuff during a measurement: systolic
pressure at 131 mmHg, diastolic pressure at
76 mmHg
Using TONOPORT V with CASE ™ / CardioSoft
TONOPORT V can be operated in conjunction with
CASE ™ (version 5.15 or later) or with the analysis
program CardioSoft (version 4.14 or later) that is
included with TONOPORT V. If the USB port is
used (CardioSoft only), it is necessary to install the
appropriate driver first (see “Software Installation”
on page 24). With these systems, individual
measurement protocols can be created and the
stored data can be reviewed on-screen in tabular
and graphic form. With V6.5 and subsequent
versions, the patient ID used by the analysis
program can be stored in TONOPORT V to allow
the collected data to be downloaded without
selecting the patient first ( refer to the respective
Operator Manuals; you will find the CardioSoft
manual on the CardioSoft CD ).
Biocompatibility
The parts of the equipment described in this
manual, including all accessories, that come in
contact with the patient during the intended use,
fulfill the biocompatibility requirements of the
applicable standards if used as intended. If you
have questions in this matter, please contact GE
Healthcare or its representatives.

Application, Safety Information
2001589-085 Revision G TONOPORT V 7
1.2 Functional Description
The TONOPORT V monitor accommodates the blood
pressure measuring system and a microprocessor for
system control and data processing. The monitor is
powered by two AA size batteries (either rechargeable
NiMH batteries or alkaline batteries).

Application, Safety Information
8 TONOPORT V 2001589-085 Revision G
1.3 Safety Information
Danger
Risk to persons —
– The equipment is not designed for use in areas
where an explosion hazard may occur. Explosion
hazards may result from the use of flammable
anesthetic mixtures with air or with oxygen,
nitrous oxide, skin cleansing agents or
disinfectants.
Warning
Risk to persons —
– Equipment may be connected to other
equipment or to parts of systems only when it
has been made certain that there is no danger to
the patient, the operator, or the environment as
a result. In those instances where there is any
element of doubt concerning the safety of
connected equipment, the user must contact the
manufacturers concerned or other informed
experts as to whether there is any possible
danger to the patient, the operator, or the
environment as a result of the proposed
combination of equipment. Compliance with the
standard IEC 60601-1 must always be ensured.
– TONOPORT V may be connected to CASE ™ or to
a PC with the CardioSoft program. While
connected to any of these devices, TONOPORT V
must be disconnected from the patient.
–
Chemicals required for the maintenance of the
equipment, for instance, must under all
circumstances be prepared, stored, and kept at
hand in their specific containers. Failure to
observe this instruction may have severe
consequences for the patient.
– The equipment has no protection against the
ingress of liquids. Liquids must not enter the
equipment. Equipment into which liquids have
entered must be inspected by a service
technician before use.
– Before cleaning, TONOPORT V must be
disconnected from other equipment (CASE
™ ,
PC).
–
Dispose of the packaging material, observing
the applicable waste-control regulations. Keep
the packaging material out of children's reach.

Application, Safety Information
2001589-085 Revision G TONOPORT V 9
Warning
Incorrect measurements —
– Magnetic and electrical fields are capable of
interfering with the proper performance of the
equipment. For this reason make sure that
external equipment operated in the vicinity of
TONOPORT V complies with the relevant EMC
requirements. X-ray equipment, MRI devices,
radio systems, etc. are possible sources of
interference as they may emit higher levels of
electromagnetic radiation.
Caution
Equipment damage, risk to persons —
– Before connecting the battery charger to the
power line, check that the voltage ratings on the
nameplate match those of your local power line.
– The battery charger is not a medical device. It
must not be used in the patient environment.
– Before using the equipment, the operator is
required to ascertain that it is in correct working
order and operating condition.
– The operator must be trained in the use of the
equipment.
– Only persons who are trained in the use of
medical technical equipment and are capable of
applying it properly are authorized to apply such
equipment.
– There are no user-replaceable components
inside the equipment. Do not open. For service
or repair, please contact your local, authorized
dealer (http://gehealthcare.com).

Controls and Indicators
10 TONOPORT V 2001589-085 Revision G
2 Controls and Indicators
Fig. 2-1 TONOPORT V controls and indicators
Functions of the Button
1Connection for blood pressure cuff
2Button : push to display the most recent
parameter readings. Readings appear in the
following order:
- systolic value "S" (unit mmHg or kPa shown on the
display)
- diastolic value "D" (unit mmHg or kPa shown on
the display)
- pulse rate "HR" (unit min-1)
The same button is used
- to toggle between the day phase and the night
phase chapter 4, section "Toggle Manually Between
Day and Night Phase") and
- to program the BP monitor (chapter 3 "Setup")
3Button : push to start and stop a
measurement, and to confirm entries
4Liquid crystal display (LCD)
5Port for connection to PC (USB)
6Port for connection to PC (RS232)
7Calibration mark
8Lid covering battery compartment
9(Rechargeable) batteries
10 ON/OFF switch
11 Nameplate
Button Message
on
display
Function
Push once H 1 clear memory
Push twice H 2 set date and time
Push 3 times H 3 select the measurement
protocol
Push 4 times H 4 activate calibration mode
Push 5 times H 5 display firmware version
Push 6 times H 6 select energy source
Push 7 times H 7 enable/disable audio signal
Push 8 times H 8 toggle pressure unit between
mmHg and kPa
S
D
HR/min
-1
START
STOP
INFO
NBP
!
off 0 on I
TONOPORT V
1
2
3
4
8
11
10
9
6
5
7
INFO
INFO
INFO
START
STOP

Controls and Indicators
2001589-085 Revision G TONOPORT V 11
Explanation of Signs and Symbols
Symbols used on the equipment and on the packaging
Symbols used on the display
Further relevant symbols used on the battery charger
Caution, consult accompanying
documents
This symbol indicates that the waste of
electrical and electronic equipment must
not be disposed as unsorted municipal
waste and must be collected separately.
Please contact an authorized
representative of the manufacturer for
information concerning the
decommissioning of your equipment.
Type BF applied part
(defibrillation-proof)
Catalogue number
Serial number
CE marking
CE marked per the Medical Device
Directive 93/42/EEC of the European
Union. The notified body is MEDCERT
GmbH.
Gossudarstwenny Standart Russia
(GOST)
In the USA, the product is only for use by
or on the order of a physician, or persons
licensed by U.S. law.
USB port, connection to PC
Serial port, connection to PC
Polarity of the DC input (charger only)
Approval mark for use of the equipment
in a vehicle (charger only, xxx-xx xxxx
alphanumeric characters)
Class II equipment
For indoor use only
0482
For indoor use only
Manufacturer’s identification
Date of manufacture.
The number found under this symbol is
the date of manufacture in the YYYY-
MM format.
Calibration mark, valid in Germany only
(see section "Technical Inspections of the
Measuring System" in chapter 8)
Mblinks with each detected oscillation; is
continuously lit when the monitor contains
data
blinks when the batteries are almost
depleted; is continuously displayed when
batteries are discharged and no more BP
measurements can be taken
day phase selected
night phase selected
TR15RA120
100-240V 0.4A
47-63Hz
12V 1.1A
Power supply type designation and
ratings
UL-certified product
Approval mark for Japan
Pollution control symbol according
to the Chinese standard SJ/T11363-
2006

Setup
12 TONOPORT V 2001589-085 Revision G
3Setup
Some Basic Facts on Battery Power
TONOPORT V is either powered by two rechargeable
Nickel Metal Hydrid batteries (NiMH) or by two alkaline
batteries. The device must be set to the power source used
(see section "Insert Batteries" below). The device also
contains a Lithium cell that powers the clock. The
Lithium cell can only be replaced by a service technician.
The capacity of two fully charged or new batteries is
sufficient for a minimum of 30 hours of operation or for
200 measurements.
The capacity of rechargeable batteries decreases with
age. If the capacity of fully charged batteries is
considerably less than 24 hours, the batteries must be
replaced.
Insert Batteries
Hold TONOPORT V as shown in Fig. 3-1 and slide
the lid of the battery compartment open (approx.
1cm).
Fig. 3-1 Opening the battery compartment
It is not possible to open the lid more than about 1 cm
which is just enough to reach the ON/OFF switch. To
replace batteries, you must take off the lid (pull upward).
Place the two batteries in the compartment as indicat-
ed by the symbols.
Select Energy Source
Turn on the BP monitor. The switch is located inside
the battery compartment. Slide the switch to the right,
while looking at the display.
Wait for the time to be displayed.
Push six times: the display shows "H 6".
Push : the display will show "AAAA" when the
BP monitor is set up for rechargeable NiMH batteries
(as shipped) and "bbbb" when it is set up for alkaline
batteries.
Confirm the displayed information with or
change the selection with and confirm the new
selection with .
Next the BP monitor will briefly display the capacity
of the inserted batteries. "A 100", for instance, means
that the rechargeable batteries have a capacity of
100%, i.e., they are fully charged. "b 50" means that
Caution
Equipment damage —
– Only use the original rechargeable, size AA Nickel
Metal Hydrid batteries (from manufacturers such
as Sanyo, Panasonic, Energizer, Duracell, Varta,
or GP) with a capacity > 1500 mAh or size AA
high-rate discharge alkaline batteries (such as
Panasonic Evoia, Energizer Ultimate, Duracell
Ultra, Duracell Power Pix, or Varta maxtech).
– Charge the NiMH batteries to capacity before
using them for the first time.
– Recharge the NiMH batteries immediately after
use and do not leave batteries uncharged.
– Use only the original charging unit to recharge
the NiMH batteries.
– Do not attempt to recharge the alkaline batteries.
– If the TONOPORT V will not be used for one
month or more, remove the (rechargeable)
batteries from the device.
– Batteries must not be disposed as unsorted
municipal waste and must be collected separately.
Please contact an authorized representative of the
manufacturer for information concerning the
decommissioning of the batteries.
Note
Switch TONOPORT V off before inserting the
batteries. To do so, slide the ON/OFF switch (10,
Fig. 2-1) to the left while looking at the display.
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP

Setup
2001589-085 Revision G TONOPORT V 13
the alkaline batteries have a capacity of only 50%,
i.e., they are half depleted.
Place the lid on the battery compartment and close.
Charge NiMH Batteries
If TONOPORT V is powered by rechargeable batteries (4
of them are shipped with the equipment), they should be
recharged immediately after use (24 hours). Use only the
original charger supplied. It consists of an AC power
adapter and the charging unit itself.
Check that the voltage ratings on the nameplate of the
charging unit match those of your local power line.
Fig. 3-2 Exchanging the connector, connecting the
charger
If necessary, replace the connector to match the wall
outlet type:
– push the button below the connector and hold it
depressed (1, Fig. 3-2)
– remove the connector and insert the suitable type
of connector 2, 3
– ensure that the new connector locks into place.
Connect the cable of the AC power adapter to the
charging unit 4and plug the AC power adapter into
the wall outlet.
Insert the two batteries into the charging unit, observ-
ing the correct polarity.
Two different charger models are available:
COMPIT TC4
VARTA
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 NiMH to alkaline
batteries and vice versa.
Caution
Equipment damage, risk to patients —
– The charger is not a medical device. It must not
be used in the patient environment.
– The contact surface of the NiMH batteries and
of the charger must always be kept clean.
– The charger is to be used indoors only and must
be protected against oil, grease, aggressive
detergents and solvents to prevent damage.
– If the charger is damaged in any way, e.g. after a
drop or when the mains pins are bent, the local
authorized dealer must be contacted immediately.
– High temperatures affect the charging process.
Ideally, the room temperature should not exceed
40 °C (104 °F).
– After quick charging, please wait for some
minutes before another quick charge.
Otherwise the temperature sensors will not
function correctly.
COMPIT
TC 4
2
43
1

Setup
14 TONOPORT V 2001589-085 Revision G
Charge Batteries with the COMPIT TC4 Charger
Fig. 3-3 Red LEDs on charger
The batteries take up to 3 hours to recharge. Each of the
red LEDs corresponds to one of the charger
compartments (Fig. 3-3). During the charge cycle, the
corresponding red LED blinks at a slow rate
(approximately once per second). Note: If the red LED
does not light up, the battery may be inserted the wrong
way round. When the battery is charged, the LED is solid
red. The charging unit now trickle-charges the battery to
compensate for self-discharging.
The battery temperature is monitored in the charger.
When the temperature is too high, the LED is solid red
and the charger switches to trickle-charging.
If the battery is correctly inserted and the red LED does
not light up, the charger has identified a battery problem.
The charging current to the compartment concerned will
be cut off. Remove the battery and discard, observing the
applicable waste-disposal regulations.
Charge Batteries with the VARTA Charger
Fig. 3-4 Battery symbols and bars in the charger display
Insert 4 or 2 batteries. To charge only 2 batteries, insert
them in the two compartments on the right or on the left.
The batteries take up to 3 hours to recharge. Once the
batteries are inserted, battery symbols will appear in the
charger display where each symbol corresponds to one of
the charger compartments (Fig. 3-4). During the charge
cycle, the corresponding bar in the battery symbols
blinks. Note: If the battery symbols and bar do not light
up, only one battery may be inserted or the batteries are
inserted the wrong way round. When the batteries are
charged, the bars are permanently illuminated. The
charging unit now trickle-charges the battery to
compensate for self-discharging.
The battery temperature is monitored in the charger.
When the temperature is too high, the bar in the battery
symbol is permanently illuminated and the charger
switches to trickle-charging.
If the batteries are correctly inserted and the displayed
battery symbols show no bars, the charger has identified
a battery problem. The charging current to the
compartment concerned will be cut off. Remove the
battery and discard, observing the applicable waste-
disposal regulations.
COMPIT
TC 4

Setup
2001589-085 Revision G TONOPORT V 15
Performance Check
When turned on, TONOPORT V runs a self-test that
includes all symbols and segments on the LCD (Fig. 3-5).
Then it checks the batteries and indicates the remaining
capacity. "A 100", for instance, means that the
rechargeable batteries have a capacity of 100%, i.e., they
are fully charged. "b 50" means that the alkaline batteries
have a capacity of only 50%, i.e., they are half depleted.
The minimum battery capacity for a 24-hour
measurement is 90%.
If the capacity is below 90%, new or fully charged
batteries must be inserted.
BP monitors that have passed the self-test and completed
the battery test will indicate the following information:
– the time of day
– the measuring phase (day / night )
– whether or not data are stored in the BP monitor (M)
(Fig. 3-6).
The BP monitor will also emit an audio signal, if enabled.
Fig. 3-5 Test display on LCD
Fig. 3-6 Example: display after successful self-test
(M= BP data in memory,
measuring phase: day)
Before using TONOPORT V on a patient
1. clear the memory
2. check date and time and correct, if required
3. select a measurement protocol
4. enable or disable the audio signal.
Clear the Memory
The symbol Mon the display indicates that memory
contains BP data. If these data still need to be analyzed,
refer to chapter 5 "Data Output" for details on data
evaluation. If you do not need the data any more, delete it
as follows:
Briefly switch TONOPORT V off and on again and
wait for the time to be displayed.
Push : the display indicates "H 1".
Push : the display indicates "LLLL".
To delete the data, push again: the display indi-
cates "0000", followed by the time (if you do not wish
to clear the memory, turn off the BP monitor instead
of pushing ).
MkPa mmHg
M
Note
When using TONOPORT V in conjunction with
CASE™/ CardioSoft, it is recommended to
perform the first three steps at the PC.
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP

Setup
16 TONOPORT V 2001589-085 Revision G
Time and Date
Usually the BP monitors are set to the correct time and
date before delivery. Therefore, the time only needs to be
corrected to change between Standard Time and Daylight
Saving Time.
Setting Date and Time
Briefly switch TONOPORT V off and on again and
wait for the time to be displayed.
Push twice: the display indicates "H 2".
Push : the display indicates the year, e.g.
"2009".
If the indicated year is correct, confirm it with
or correct it with and confirm with .
– The display indicates the month, e.g. "03".
If the indicated month is correct, confirm it with
or correct it with and confirm with .
In the same manner, correct day, hour and minute.
In the end, the time of day will be displayed again.
Selecting the Pressure Unit
Briefly switch TONOPORT V off and on again and
wait for the time to be displayed.
Push eight times: the display indicates "H 8".
Push : the display indicates "mmHg" or "kPa".
Confirm the pressure unit with or select the oth-
er unit with , then confirm with .
Measurement Protocols
There is a choice of three different measurement
protocols:
Max. inflation pressure: day phase 250 mmHg
night phase 220 mmHg
Select a Measurement Protocol
Briefly switch TONOPORT V off and on again and
wait for the time to be displayed.
Push three times: the display indicates "H 3".
Push : the display indicates "LLLL" (Selecting
a protocol automatically clears the memory. If you do
not wish to clear the memory, turn the BP monitor
off.)
Push : the display indicates "P1" (protocol 1).
Using , select protocol 2 or 3
OR
Confirm the displayed protocol with .
Enable or Disable the Audio Signal
Briefly switch TONOPORT V off and on again and
wait for the time to be displayed.
Push seven times: the display indicates "H 7".
Push : the display indicates "0000" when the au-
dio signal is turned off, and "1111" when it is turned
on.
Either confirm the setting with or press to
select the alternate setting and confirm with .
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
Protocol Day Phase
(7 a.m. to 10 p.m.)
Night Phase
(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
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP

Application
2001589-085 Revision G TONOPORT V 17
4 Application
Symbols used on the cuff Cleaning the Cuffs
– The single-use cuffs may not be reused. Therefore,
these cuffs need not to be cleaned.
– Use a moist cloth to wipe the cuffs clean if they are
only slightly soiled.
– Clean cuffs that are heavily contaminated by washing
them with soapy 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 tubing.
– After cleaning, rinse the cuff thoroughly with water
and let it dry at room temperature for about 15 hours.
– The cuffs can be disinfected with isopropyl alcohol
70%, ethanol 70%, mikrozid universal liquid, Buraton
rapid, Sporicidin, or Cidex. After disinfection, rinse
the cuff thoroughly with tap water and air-dry.
Follow the instructions given in the
operator manual.
Blood pressure cuff fits adult
patient of the size marked by the
frame (Standard, Small, Large, or
Extra-large).
Blood pressure cuff is suitable for
the indicated arm circumference.
When the blood pressure cuff is
applied, this label must face the skin
(single-use cuff).
When the blood pressure cuff is
applied, this arrow must be located
over the brachial or femoral artery.
This line identifies the end of the
cuff which must be situated within
the range identified by the INDEX
label when the cuff is closed.
The end of the cuff must be situated
within this range when the cuff is
closed.
Latex-free blood pressure cuff.
Single-use device.
CE marking, cuff fulfills EU
regulation.
Caution
Used single-use-cuffs may be contaminated
and /or damaged.

Application
18 TONOPORT V 2001589-085 Revision G
Fig. 4-1 Applying the cuff
Fig. 4-2 Applying the cuff
Applying the Cuff
Always insert 2 fully charged NiMH batteries or two
new alkaline batteries, before starting a measurement.
Check that the memory has been cleared (see
"Clearing the Memory").
Select the appropriate cuff size (see cuff label). When
the cuff is too small the BP values will be
overrated, when it is too big, the measured values
will be too low.
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 change the cuff level. Verify that
– the cuff tubing points up toward the shoulder (Fig.
4-1)
– no compression or restriction of connection tubing
can occur
– the side with the label is on the skin (sin-
gle-use cuffs)
– the arrow is located above the brachial or femoral
artery
– the dashed white line at the end of the cuff is
located between the two dashed lines
when you close the cuff (if this is not the case,
select another cuff size, Fig. 4-2)
– the cuff fits snugly around the arm, but does not
compress the blood vessels
– the cuff and the TONOPORT V are used inside
the ambient conditions for operation and inside
the measuring range (see chapter "Technical
Specifications").
Warning
Risk to Persons—
– The effect of blood flow interference can result in
a harmful injury to the patient caused by
continuous cuff pressure due to connection tubing
kinking.
– Too frequent measurements can cause injury to
the patient due to blood flow interference.
– The application of the cuff over a wound can cause
further injury.
– The application of the cuff and its pressurization
on the arm on the side of a mastectomy is not
recommended.
– The pressurization of the cuff can temporarily
cause loss of function of simultaneously used
monitoring equipment on the same limb.
– By watching the limb it is necessary to check that
operation of the TONOPORT V does not result in
prolonged impairment of patient blood
circulation.
Index
Index
Index
Warning
Risk to Persons—
Disconnect TONOPORT V from other equipment
(CASE, PC) before connecting it to the patient.
Caution
Incorrect measurements—
– Use only the cuffs listed in chapter "Order
Information".
– Replace cuffs on a regular basis. Damaged Velcro
fasteners may cause incorrect readings.
– When using a small cuff, only the deflation
measurement method should be used (see chapter
"General Information on Ambulatory BP
Measurement").

Application
2001589-085 Revision G TONOPORT V 19
Initiate a Trial Measurement
Turn on TONOPORT V and place it in the carrying
pouch. There is an aperture in the pouch to accommo-
date the cuff connection tube.
Attach the pouch to the patient (shoulder strap, belt).
For reasons of hygiene, it is not advised to carry the
pouch on the bare skin.
Guide the pressure tubing around the patient's neck as
a strain relief and connect it to the blood pressure cuff
port on the TONOPORT V (1, Fig. 2-1). Advise the
patient to avoid kinking the tubing during the mea-
surement.
Check that the display indicates the time of day. If the
memory contains data from a previous procedure, the
letter "M" will appear on the display when you turn on
the device. If you still try to initiate a measurement,
the message "LLLL" prompts you to clear the memo-
ry. Push twice to delete the data. If you do not
wish to delete the data, turn off the device instead of
pushing .
To avoid erroneous measurements, ensure that the
patient does not move during the trial measure-
ment. The patient may stand or sit.
Push to initiate the first measurement.
Within a few seconds, the device starts inflating the cuff.
When the inflation pressure has been reached, the cuff
will gradually be deflated. The changing cuff pressure is
indicated on the display and the letter "M" appears with
each detected oscillation. At the end of the measurement
the measured data appears in the following order
– the systolic reading (S in mmHg or kPa)
– the diastolic reading (D in mmHg or kPa)
– the pulse rate (HR/min-1).
If an error code, such as "E 29" (insufficient number of
oscillations detected) is displayed after the measurement,
tighten the cuff a little and push again (see also
chapter 6 "Error Codes").
If the trial measurement has been successfully completed,
the device is ready for automatic measurements.
Patient Information
Advise your patient
– not to move while a measurement is being taken to
avoid motion artifacts that may lead to erroneous
readings and to keep the cuff inflation time as
short as possible
– to place TONOPORT V on the night stand while in
bed
– how to switch the device manually from the day to the
night phase (see page 21)
– that events considered important should be noted
down in a diary and that intermediate measurements
can be initiated with
– that the measurement can be stopped at any time with
(the cuff will be deflated)
– not to open the battery compartment
– about the audio signal and its meaning.
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
Warning
Risk to persons —
Instruct your patient
– to terminate the measurement with ,
whenever the cuff is not deflated within about
2minutes,
– to remove the cuff if it is not deflated after
activation of the button. This could be due
to kinked tubing. The cuff must be reapplied as
described earlier before additional
measurements can be taken.
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP

Application
20 TONOPORT V 2001589-085 Revision G
Absolute contraindications:
The application of the cuff is prohibited on an arm with
– dialysis shunt
– fresh operation wounds
– mastectomy
Relative contraindications:
If the doctor ascertains a positive benefit-risk ratio, the
application of the cuff is allowed on the arm with:
– lymphedema
– paresis or plegia
– arterial or venous vascular access
Other diagnostic or therapeutic measures do not
negatively affect the blood pressure measurement.
Note
The operator's manual is restricted to professional
healthcare personnel. Do not deliver this document
to the patient. Please give the patient a copy of the
patient instructions (see page 36).
Note
Professional healthcare personnel have to give the
patient some information about the accuracy of the
TONOPORT V.