GE TONOPORT VI User manual

GE Healthcare
TONOPORT VI
Ambulatory Blood Pressure System
Firmware Version 3.0
Operator's Manual
2001589-312 ENG Revision B

2TONOPORT VI 2001589-312 Revision B
Note
The information in this manual only applies to TONOPORT VI, firmware version 3.0. It does not apply to earlier
firmware versions.
Due to continuing product innovation, specifications in this manual are subject to change without notice.
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Contents
2001589-312 Revision B TONOPORT VI 3
1 Application, Safety Information 7
2 Controls and Indicators 11
3 Setup 13
4 Application 19
5 Data Output 24
6 Error Codes 25
7 Software Installation 26
8 Cleaning, Maintenance, Disposal 27
9 Technical Specifications 29
10 Order Information 30
11 Appendix - Electromagnetic Compatibility (EMC) 31

Revision History
4TONOPORT VI 2001589-312 Revision B
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
2001589-312 Revision A 2018-05 Initial Release
2001589-312 Revision B 2020-02-26 Updated for MDR requirements.
Updated "Intended Use" section.
Updated "Signs and Symbols" section.
Updated "Application" section.
Updated "Order Information" section.
Updated "Appendix - Electromagnetic Compatibility (EMC)"
section.

General Information
2001589-312 Revision B TONOPORT VI 5
General Information
The product TONOPORT VI bears the CE marking
CE 0482 (notified body MEDCERT GmbH) since
2017 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. The cuffs
listed in chapter 10 are class I devices and fulfill the
General Safety and Performance Requirements of
Annex I of the Regulation (EU) 2017/745 (Medical
Device Regulation MDR). They are marked with the
CE symbol.
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 product is clinically validated. The validation
fulfills the standard ISO 81060-2:2013 " Non-
invasive sphygmomanometers - Part 2: Clinical
investigation of automated measurement type" and
the protocol ESH-IP 2010 from the European Society
of Hypertension.
The radio-interference emitted by this product is
within the limits specified in CISPR11/EN 55011,
class B.
 The TONOPORT VI recording unit, cuffs and
wearable pouch are certified by UL and thus fulfil the
UL safety requirements.
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: Follow the instructions
given in the operator manual. It indicates points
which are important to avoid faulty measurements or
injuries like strangulation of the arm.
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 Field
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 using only original
accessories available through GE Healthcare. The
user is responsible for application of accessories from
other manufacturers.
Any serious incident occurring in relation to the
device should be reported to the manufacturer and the
competent authority of the Member State in which the
user and/or patient is established.
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 haz-
ard may result in minor injury and/or product/prop-
erty damage.

General Information
6TONOPORT VI 2001589-312 Revision B
PAR Medizintechnik GmbH & Co. KG
Sachsendamm 6
10829 Berlin, Germany
Germany
Tel. [phone]
Fax [phone]
GE Medical Systems
Information Technologies, Inc.
9900 Innovation Drive
Wauwatosa, WI 53226 USA
The country of manufacture is indicated on the device la-
bel.

Application, Safety Information
2001589-312 Revision B TONOPORT VI 7
1 Application, Safety Information
1.1 Application
Intended use
TONOPORT VI is a small-size, portable blood pressure
monitor for ambulatory, non-invasive measurement of
the patient’s blood pressure. If the blood pressure cuffs
listed in chapter "Order Information" fit the patient, it can
be used on adults, children, and small children.
TONOPORT VI is not suitable for blood pressure
measurements in neonates. Also, it is not suitable for use
in intensive-care medicine. TONOPORT VI is intended
for use following consultation and instruction by a
physician.
The device supports the physician in the diagnosis and
supervision of pathophysiological blood pressures like
hypertension or hypotension. To establish a diagnosis the
measurement values should be combined with other
measurements and physical examinations of the patient.
TONOPORT VI can record up to 400 blood pressure
measurements at selectable intervals and save the results.
There is a choice of three different measurement
protocols.
Oscillometric Measurement 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.
In order to measure the blood pressure, a blood pressure
cuff wrapped around the upper arm needs to be inflated
and subsequently deflated. The blood pressure is
determined either during deflation of the cuff (deflation
measurement method) or, by using a novel and faster
technology, already during inflation of the cuff (inflation
measurement method).
The deflation measurement method is the most common
method used. With this technique, the cuff is inflated to a
pressure which must be clearly above the expected
systolic value. Including cuff inflation, the measurement
typically takes approx. 40 seconds.
Fig. 1-1 Waveform representing the pressure in the cuff
during a measurement using the deflation
measurement method: systolic pressure at
125 mmHg, diastolic pressure at 83 mmHg
Note
CASE / CardioSoft v6.73 supports only up to 200
memory readings.
Using TONOPORT VI with CASE/CardioSoft
TONOPORT VI can be operated in conjunction
with CASE (version 6.73 or later) or with the
analysis program CardioSoft (version 6.73 or later)
that is included with TONOPORT VI. If the USB
port is used, it is necessary to install the appropriate
driver first (see "Software Installation"). With these
systems, individual measurement protocols can be
created and the stored data can be reviewed on
screen in tabular and graphic form. The patient ID
used by the analysis program can be stored in
TONOPORT VI to allow the collected data to be
downloaded without selecting the patient first (refer
to the respective Operator Manuals).
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 representative.

Application, Safety Information
8TONOPORT VI 2001589-312 Revision B
The inflation measurement method is a novel method
based on the "Inflation Measurement Technology (IMT)"
developed by PAR Medizintechnik. With this innovative
technique, the cuff is inflated to a pressure just above the
expected systolic value. Once the systolic value is
determined, the cuff can immediately and quickly be
deflated. The measurement typically takes only approx.
20 seconds.
If disturbances occur during measurements with the
inflation measurement method, which may be due to
motion artifacts, for example, TONOPORT VI will
automatically switch to the deflation measurement
method and complete the blood pressure measurement.
Fig. 1-2 Waveform representing the pressure in the cuff
during a measurement using the inflation
measurement method: systolic pressure at
125 mmHg, diastolic pressure at 83 mmHg
With both methods, a pressure transducer measures the
cuff pressure as well as the superimposed pressure
pulsations. During blood pressure measurements the cuff
must be at heart level. 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.
1.2 Functional Description
The TONOPORT VI monitor accommodates the blood
pressure measuring system and a microprocessor for
system control and data processing.
A second microprocessor with a second pressure
transducer and a second valve are provided for control of
the technical safety.
The monitor is powered by two AA size batteries (either
rechargeable NiMH batteries or alkaline batteries).

Application, Safety Information
2001589-312 Revision B TONOPORT VI 9
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 (N2O), 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
operators, 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 or IEC 60950-1 must
always be ensured.
– Connection of this device to an IT-network that
includes other equipment could result in
previously unidentified risks to patients, operators
or third parties. The responsible organization
should identify, analyze, evaluate and control
these risks.
– Changes to the IT-network could introduce new
risks that require additional analysis.
Changes to the IT-network include:
• changes in network configuration
• connection of additional items (e.g. connecting
another TONOPORT device to another port of
the PC can lead to interference during data
transfer)
• disconnection of items
• update or upgrade of equipment
– TONOPORT VI may be connected to CASE or to
a PC with the CardioSoft program. While
connected to any of these devices, TONOPORT VI
must be disconnected from the patient.
– Chemicals required, for example, for the
maintenance of the equipment must under all
circumstances be prepared, stored, and kept at
hand in their specific containers. Failure to
observe this instruction may have severe
consequences.
– 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.

Application, Safety Information
10 TONOPORT VI 2001589-312 Revision B
Warning
Risk to Persons—
– Before cleaning, TONOPORT VI 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.
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 VI 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. Its use
in the patient environment is not permitted.
– Before using the equipment, the operator must
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 the housing. For
service or repair, please contact your local,
authorized dealer (http://gehealthcare.com).

Controls and Indicators
2001589-312 Revision B TONOPORT VI 11
2 Controls and Indicators
Fig. 2-1 Controls and indicators of TONOPORT VI
Functions of Button
1Button : push to display the most recent pa-
rameter readings. The display will show:
- 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 (section "Toggling Between Day and Night
Phase") and
- to program the BP monitor (chapter 3 "Setup")
2Connection for blood pressure cuff
3Calibration mark
4Liquid crystal display (LCD)
5Button : push to start and stop a measure-
ment and to confirm entries
6(Rechargeable) batteries
7Lid covering battery compartment
8Nameplate
9Port for connection to PC (RS232)
10 Port for connection to PC (USB)
12
3
4
5
6
7
8
9
10
Button Mes-
sage on
display
Function
Push once H 1 clear memory
Push twice H 2 set date and time
Push 3 times H 3 select 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
Push 9 times H 9 select measurement method:
deflation measurement
method or inflation
measurement method
INFO
INFO
INFO
START
STOP

Controls and Indicators
12 TONOPORT VI 2001589-312 Revision B
Explanation of Signs and Symbols
Symbols used on the equipment and on the packaging
Follow the instructions given in the
operator manual.
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, recovery time tR < 1 s)
Article number
Serial number
Lot number
UDI-DI UDI-DI number
Medical device
CE marked per the Council Directive
93/42/EEC of the European Union.
Notified body: MEDCERT GmbH.
Gossudarstwenny Standart Russia
(GOST)
Eurasian Conformity mark.
Conformity to applicable technical
regulations of Customs Union.
MEDICAL - PATIENT-
MONITORING EQUIPMENT AS TO
ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005) + AMD 1 (2012),
CAN/CSA-C22.2 No. 60601-1 (2014),
IEC 60601-1-6 (2010, A1:2013), IEC
60601-1-11 (2015), IEC 80601-2-30
(2009, A1:2013)
Caution: Federal law restricts this device
to sale by or on the order of a physician.
0482
IP20
Protection against ingress of solid
foreign objects and no protection against
ingress of water.
IP02
No protection against contact and
ingress of objects and protection against
dripping water when tilted at 15°.
Keep dry
Temperature limits
Humidity limits
Air pressure limits
USB port, connection to PC
Serial port, connection to PC
Manufacturer’s identification
Date of manufacture.
The number found under this symbol is
the date of manufacture in the YYYY-
MM format.
Distributor‘s identification
Calibration mark, valid in Germany only
(see "Technical Inspections of the
Measuring System")

Setup
2001589-312 Revision B TONOPORT VI 13
Symbols used on the display
Further relevant symbols used on the battery charger
3 Setup
Some Basic Facts on Battery Power
TONOPORT VI is either powered by two rechargeable
nickel-metal hydride batteries (NiMH) or by two alkaline
batteries. The device must be set to the power source used
(see section "Inserting Batteries"). 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 up to 400 blood pressure 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.
MBlinks with each detected oscillation; is
continuously displayed 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
Polarity of the DC input (charger
only)
Approval mark for use of the
equipment in a vehicle (charger
only, xxx-xx xxxx alphanumeric
characters)
Protection class II equipment
For indoor use only
Approval mark for Japan
China RoHS pollution control
label
RoHS Restriction of certain hazardous
substances.
The device fulfills the
requirements of the Directive
2011/65/EU (RoHS 2) of the
European Parliament and of the
Council and the amendment (EU)
2015/863 (RoHS 3) of the
European Parliament and of the
Council.
+
E4
x
xx-xxxx
xx
PS
E
Caution
Equipment Damage—
– Only use the original rechargeable, size AA nickel-
metal hydride batteries (from manufacturers such
as Sanyo, Panasonic, Energizer, Duracell, Varta,
GP) with a capacity > 1500 mAh or high-rate
discharge, size AA alkaline batteries (such as
Panasonic Evoia, Energizer Ultimate, Duracell
Ultra, Duracell Power Pix, 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 charger to recharge the
NiMH batteries.
– Do not attempt to recharge alkaline batteries.
– If TONOPORT VI 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.

Setup
14 TONOPORT VI 2001589-312 Revision B
Inserting Batteries
Open the battery compartment on the back of
TONOPORT VI as shown in Fig. 3-1.
Fig. 3-1 Opening the battery compartment
Place the two batteries in the compartment as
indicated by the symbols.
Selecting the Energy Source
Turn on the BP monitor as follows:
either by inserting the batteries or by briefly pressing
the button.
Wait for the time to be displayed.
Push six times: The display shows "H 6".
Push : the display shows "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
the alkaline batteries have a capacity of only 50%,
i.e., they are half depleted.
Place the lid on the battery compartment and close.
Charging NiMH Batteries
If TONOPORT VI 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.
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.
START
STOP
INFO
START
STOP
START
STOP
INFO
START
STOP
Caution
Equipment damage, patient hazard —
– The battery charger is not a medical device. Its use
in the patient environment is not permitted.
– 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.
– After quick charging, please wait for some minutes
before another quick charge. Otherwise the
temperature sensors will not function correctly.

Setup
2001589-312 Revision B TONOPORT VI 15
Fig. 3-2 Exchanging the connector, connecting the
charging unit
Check that the voltage ratings on the nameplate of the
charging unit match those of your local power line.
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 4 and plug the AC power adapter into
the wall outlet.
Insert the two rechargeable batteries into the charging
unit, observing the correct polarity.
Charging Batteries with the VARTA Charging Unit
Fig. 3-3 Battery symbols and bars in the charging unit
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
charging unit display where each symbol corresponds to
one of the charger compartments (Fig. 3-3). 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
batteries 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 will be cut off.
Remove the batteries and discard, observing the
applicable waste disposal regulations.

Setup
16 TONOPORT VI 2001589-312 Revision B
Switching TONOPORT VI ON and OFF
The TONOPORT VI monitor has no power switch.
Switch the device on and off as follows:
To switch ON: Insert charged batteries OR
briefly press .
To switch OFF: Press for 3 seconds.
Performance Check
When turned on, TONOPORT VI runs a self-test that
includes all symbols and segments on the LCD (Fig. 3-4).
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 ), and
– whether data are stored in the BP monitor (M) (Fig. 3-
5).
The BP monitor will also emit an audio signal if enabled.
Fig. 3-4 Test display on LCD
Fig. 3-5 Example: display after successful self-test (M=
BP data in memory, measuring phase:
day)
START
STOP
START
STOP

Setup
2001589-312 Revision B TONOPORT VI 17
Before using TONOPORT VI on a patient
1. clear the memory
2. check date and time and adjust if required
3. select a measurement protocol
4. enable or disable the audio signal.
Clearing the Memory
The symbol M on the display indicates that the memory
holds 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 VI 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
indicates "0000", followed by the time (if you do not
wish to clear the memory, turn off the BP monitor
instead of pushing ).
Selecting the Measurement Method
Briefly switch TONOPORT VI off and on again and
wait for the time to be displayed.
Push 9 times: the display indicates "H 9".
Push : the display indicates "0000" if the
selected method is the deflation measurement
method, or "1111" if the selected method is the
inflation measurement method.
Either confirm with or switch to the other op-
tion with , then confirm with .
Note
When using TONOPORT VI in conjunction with
CASE/CardioSoft, it is recommended to perform
the first three steps at the PC.
INFO
START
STOP
START
STOP
START
STOP
INFO
START
STOP
START
STOP
INFO START
STOP

Setup
18 TONOPORT VI 2001589-312 Revision B
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 Time and Date
Briefly switch TONOPORT VI off and on again and
wait for the time to be displayed.
Push twice: the display indicates "H 2".
Push : The year will be displayed, e.g. "2020".
If the indicated year is correct, confirm it with
or correct it with , then confirm with .
The month will be displayed, e.g. "03".
If the indicated month is correct, confirm it with
or correct it with , then 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 VI off and on again and
wait for the time to be displayed.
Push 8 times: the display indicates "H 8".
Push : the display indicates "mmHg" or "kPa".
Either confirm with or switch to the other
option 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
Selecting a Measurement Protocol
Briefly switch TONOPORT VI off and on again and
wait for the time to be displayed.
Push 3 times: the display indicates "H 3".
Push : the display indicates "LLLL" (Selecting
a protocol automatically clears the memory. If you
want to retain the data, switch the BP monitor off.)
Push : the display indicates "P1" (protocol 1).
Either select program 2 or 3 by pushing or
confirm the selected protocol with .
Enabling or Disabling the Audio Signal
Briefly switch TONOPORT VI off and on again and
wait for the time to be displayed.
Push 7 times: the display indicates "H 7".
Push : the display indicates "0000" when the
audio signal is disabled, and "1111" when it is
enabled.
Either confirm with or switch to the other
option with , then confirm with .
INFO
START
STOP
START
STOP
INFO START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
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
INFO
START
STOP
START
STOP
INFO
START
STOP
INFO
START
STOP
START
STOP
INFO START
STOP

Application
2001589-312 Revision B TONOPORT VI 19
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
directives.

Application
20 TONOPORT VI 2001589-312 Revision B
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 VI 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 VI does not result in
prolonged impairment of patient blood circulation.
Index
Index
Index
Warning
Risk to Persons—
Disconnect TONOPORT VI 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").