PAR PHYSIO-PORT UP User manual

PHYSIO-PORT UP
Ambulatory Blood Pressure System
Firmware Version 3.0
Operator's Manual
A9951 - ENG Revision C

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PHYSIO-PORT UP
A9951 Revision C
Note
The information in this manual only applies to PHYSIO-PORT UP, 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.
© 2023 PAR Medizintechnik GmbH & Co. KG. All rights reserved.

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Table of Contents
Table of Contents
1Application, Safety Information 6
2Controls and Indicators 10
3Setup 12
4Application 17
5Data Output 21
6Error Codes 22
7Software Installation 23
8Cleaning, Maintenance, Disposal 25
9Technical 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
A9951 - ENG RevisionA
2017-05
Initial Release
A9951 - ENG RevisionB
2022-03-28
Changing of the manufacturer Address
A9951 - ENG RevisionC
2023-02-09
Updated for MDR requirements of the PHYSIO-PORT
UP device. Update of the order information in Chapter 10,
Change of the battery charger

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Revision History
General Information
The product PHYSIO-PORT UP bears the CE
marking CE 0482 (notified body MEDCERT
GmbH) indicating its compliance with the
provisions of the Regulation (EU) 2017/745
(Medical Device Regulation MDR) about medical
devices and fulfills the essential requirements of
Annex I of this regulation. The devices have an
internal power source and are MDR class IIa
devices. The devices fulfill the requirements of the
Directive 2011/65/EU of the European Parliament
and of the Council and its amending Directive (EU)
2015/863 of the European Parliament and of the
Council. The cuffs listed in Chapter 10 are a class I
device 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
safety standard for automatic sphygmomanometers
80601-2-30 and 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 “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 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’s 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, PAR Medizintechnik will provide a
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
hazard may result in minor injury and/or
product/property damage.

General Information
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PAR Medizintechnik GmbH & Co. KG
Rigistr. 11
12277 Berlin
Germany
Tel. [phone]
The country of manufacture is indicated on the device label.

General Information
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1 Application, Safety Information
1.1 Application
Intended Use
The PHYSIO-PORT UP device is intended to be used
in combination with a suitable blood pressure cuff for
the automatic non-invasive measurement of the blood
pressure (single or 24-h-measurement of the systolic,
diastolic and mean value), the heart rate and other vital
or non-vital sign parameters of human beings in the
clinical daily routine.
Indications
If the blood pressure cuffs listed in chapter "Order
Information" on page 28 fit the patient, it can be used
on adults and pregnant (including pre-eclamptic)
women.
PHYSIO-PORT UP is not suitable for blood pressure
measurements in neonates. Also, it is not suitable for
use in intensive-care medicine. PHYSIO-PORT UP is
intended for use following consultation and instruction
by a physician.
PHYSIO-PORT UP can record up to 400 blood
pressure measurements at selectable intervals and save
the results.
There is a choice of three different measurement
protocols.
The 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 deter- mined 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 com-
mon 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. (see
Fig. 1-1).
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
The inflation measurement method is a novel method
based on the "Inflation Measurement Technology
(IMT)" developed by PAR Medizintechnik. With this
Note
The software PhysioPortWin supports up to 400
memory readings.
Using PHYSIO-PORT UP with PhysioPortWin
PHYSIO-PORT UP can be operated in conjunction
with PhysioPortWin. If the USB port is used, it is
necessary to install the appropriate driver first (see
"Software Installation" on page 23). 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
PHYSIO-PORT UP to allow the collected data to be
downloaded without selecting the patient first (refer
to the respective Operator Manuals; you will find
the PhysioPortWin manualon the USB-Stick ).
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 PAR
Medizintechnik.

Application, Safety Information
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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. (see Fig. 1-2)
If disturbances occur during measurements with the
inflation measurement method, which may be due to
motion artifacts, for example, PHYSIO-PORT UP 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. (Each 10 cm
difference result in a pressure deviation of 8.0 mmHg.)
When the patient is sitting, lying, or standing during
measurements the cuff is automatically at the correct
level.
1.2 Functional Description
The PHYSIO-PORT UP 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
Application, Safety Information
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1.3 Safety Information
xy
b
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. To ensure
such a secure connection the equipment or parts of
systems have to comply with the standard IEC
60601-1 or IEC 60950-1.
 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:
ochanges in network configuration
oconnection of additional items
(e.g. connecting another PHYSIO-
PORT UP device to another port of the
PC can lead to interference during data
transfer)
odisconnection of items
oupdate or upgrade of equipment
 PHYSIO-PORT UP may be connected to a PC
with the PhysioPortWin software. While
connected to any of these devices, PHYSIO-
PORT UP must be disconnected from the patient.
 Chemicals required, for example, for the
mainte nance of the equipment must under all
circum stances 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
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x
Warning
Risk to Persons —
Before cleaning, PHYSIO-PORT UP must be
disconnected from other equipment (f. e. 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
PHYSIO-PORT UP 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
the manufacturer or your local, authorized
dealer (http://www.par-berlin.com).

Application, Safety Information
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2 Controls and Indicators
Fig. 2-1 Controls and indicators of PHYSIO-PORT UP
Functions of Button
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 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
1
Button : push to display the most recent para-
meter 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")
2
Connection for blood pressure cuff
3
Calibration mark
4
Liquid crystal display (LCD)
5
Button : push to start and stop a
measurement and to confirm entries
6
(Rechargeable) batteries
7
Lid covering battery compartment
8
Nameplate (example)
9
Port for connection to PC (RS232)
10
Port for connection to PC (USB)

Setup
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Explanation of Signs and Symbols
Symbols used on the equipment and on the packaging
Follow the instructions given in the
operator’s manual.
This symbol indicates that the waste of
electrical and electronic equipment must
not be disposed an unsorted municipal
waste and must be collected separately.
Please contact an authorized
representative of the manufacturer for
information concerning the
decommissioning if your equipment.
Type BF applied part (defibrillation-proof,
recovery time tR< 1s)
Article number (Manufacturer)
Serial number
Quantity
Medical device
CE marked per the Regulation (EU)
2017/745 of the European Union.
Notified body: MEDCERT GmbH
Protection against ingress of solid foreign
objects and no protection against ingress
of water.
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.
Ambulant Blood Pressure Measurement
Device
PC System Ambulant Blood Pressure
Measurement Device
Calibration mark, in Germany mandatory
(see “Technical Inspection of the
Measuring System”)
Symbols used on the display
Blinks 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 measurement can
be taken.
Day phase selected
Night phase selected
Further relevant symbols used on the battery charger
Protection class II equipment
For indoor use only
UL marking
M

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Controls and Indicators
Symbols used on the blood pressure cuff
Follow the instructions given in the
operator manual.
Blood pressure cuff is suitable for
adults of the framed size (Medium-
sized, Small, Large, Extra-Large)
Lot number
UDI-DI
UDI-DI number
Blood pressure cuff is suitable for the
indicated arm circumference
ARTERIA
When applying the cuff, this arrow has
to lie on the brachial artery.
The end of the cuff must be situated
within this range when the cuff is
closed.
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.
Latex-free blood pressure cuff.
CE marking, blood pressure cuff
complies with (EU) 2017/745.
3 Setup
Basic Facts about the sBattery Supply
PHYSIO-PORT UP 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 48 h of operation or 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.
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 PHYSIO-PORT UP 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
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Inserting Batteries
Open the battery compartment on the back of
PHYSIO-PORT UP 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 PHYSIO-PORT UP 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.
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 contact 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.

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Application
Fig. 3-2 Charging unit and power supply and USB
cable
Fig 3-3 European plug for the battery charger,
international plugs are available on request.
Check that the voltage ratings on the nameplate of
the charging unit match those of your local power
line.
Connect the cable of the AC power adapter to the
charging unit and plug the AC power adapter into
the wall outlet.
Insert two or four rechargeable batteries into the
charging unit, observing the correct polarity.
Charging Batteries with the Charging Unit
To charge the NiMH batteries that are part of the PC-
system, follow the instructions given in the
accompanying manual for the battery charger.
Switching PHYSIO-PORT UP ON and OFF
The PHYSIO-PORT UP 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: Remove the batteries or press for 3
seconds.
Performance Check
When turned on, PHYSIO-PORT UP 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) (see
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)

Setup
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Before using PHYSIO-PORT UP 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 Mon 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 PHYSIO-PORT UP 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 PHYSIO-PORT UP 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
option with , then confirm with .
Note
When using PHYSIO-PORT UP in conjunction with
PhysioPortWin, it is recommended to perform the
first three steps at the PC.

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Setup
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 PHYSIO-PORT UP 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 PHYSIO-PORT UP 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:
Protocol
Day Phase
(7 a.m. to 10 p.m.)
Night Phase
(10 p.m. to 7 a.m.)
P 1
every 15 minute
every 30 minute
P 2
every 20 minute
every 40 minute
P 3
every 30 minute
every 60 minute
Max. inflation pressure: day phase 250 mmHg
night phase 220 mmHg
Selecting a Measurement Protocol
Briefly switch PHYSIO-PORT UP 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 PHYSIO-PORT UP 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 .

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Application
4 Application
Applying the Cuff
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.
Fig. 4-1 Applying the cuff
Fig. 4-2 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").
Warning
Risk to Persons —
Disconnect PHYSIO-PORT UP from other
equipment (f. e. PC) before connecting it to the
patient.
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 PHYSIO-PORT UP does not result
in prolonged impairment of patient blood
circulation.
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
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A9951 Revision C
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. Bending the arm must not change the
cuff level.
It is recommended to place a hose made of mull
between arm and cuff.
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
(single-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, see Fig. 4-2),
the cuff fits snugly around the arm but does not
compress the blood vessels
the cuff and the PHYSIO-PORT UP are used
inside the ambient conditions for operation and
inside the measuring range (s. chapter „Technical
Specifications“
Performing a Trial Measurement
Turn on PHYSIO-PORT UP and place it in the
wearable pouch. There is an aperture in the pouch to
accommodate 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 of PHYSIO-PORT UP (2, Fig. 2-1). Do
not wrap the pressure tubing completely around the
neck to avoid strangulation of the patient. You must
hear the connector click into place. Ensure that the
tube is not kinked or blocked during the
measurement.
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 memory. Push twice
to delete the data. If you want to retain the data, turn
off the device instead of pushing .)
To avoid erroneous measurements, ensure that
the patient does not move during the trial
measurement. 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 (deflation measurement
method) or the pressure will be released quickly
(inflation measurement method). 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 will be displayed
the systolic readings (S in mmHg or kPa)
the diastolic readings (D in mmHg or kPa) and
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 „Error Codes).
If the trial measurement has been completed
successfully, the device is ready for automatic
measurements.

19
PHYSIO-PORT UP
A9951 Revision C
Application
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 the PHYSIO-PORT UP with the wearable
pouch on the night stand while in bed,
how to switch the device manually from the day to
the night phase (see chapter „Toggling Between
Day and Night Phase“),
to note down special circumstances such as driving
in a car or using public transport, which may cause
erroneous measurements due to vibrations, or
situations of emotional stress; this information will
help you as a doctor to interpret the measurements
in context
that measurements can be initiated in these
situations by pressing ,
that the measurement can be stopped at any time
with (the cuff will be deflated),
not to open the battery compartment or the device,
about the audio signal an its meaning,
to protect the device against water, excessive
humidity and excessive temperatures,
not to remove the device from the wearable pouch,
to remove the pressure hose only in emergency
situations (see warning below),
that the cleaning may only be carried out by
qualified medical personnel and not by the patient.
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.
Warning
Risk to Persons —
Instruct your patient
to terminate the measurement with ,
whenever the cuff is not deflated within about 2
minutes,
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.
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 instruction (see page 36).
Note
Professional healthcare personnel have to give
some information about the accuracy of the
PHYSIO-PORT UP to the patient.

20
PHYSIO-PORT UP
A9951 Revision C
Data Output
General Information on Ambulatory
BP Measurement
These are the buttons on PHYSIO-PORT UP used
during an ambulatory blood pressure measurement:
starts and stops a measurement
displays the most recent measurement
results or the most recent error message,
toggles between day and night phase
(see next section)
Deflation Measurement Method:
For the first measurement, the cuff is inflated to a
pressure of 160 mmHg (initial pressure). For subsequent
measurements, the device inflates the cuff to a pressure
which is 15 mmHg above the systolic value of the
previous measurement (minimum inflation pressure:
120 mmHg). If the measured value is above the inflation
pressure, the device will increase the cuff pressure
another 50 mmHg.
Inflation Measurement Method:
For each measurement, the device inflates the cuff to a
pressure just above the expected systolic pressure.
A manual measurement can be taken at any time
between the automatic measurements. Manual
measurements are marked in the tabular BP data in the
software PhysioPortWin.
If unsuccessful, the device will repeat a measurement
after 2 minutes. An error code referring to failed
measurements is generated in PhysioPortWin only after
three consecutive unsuccessful measurements.
Error codes E02 (battery depleted), E06 (inflation time
over) and E08 (maximum number of pressure
measurements taken –200 or 400) do not lead to a
second measurement. The next measurement after error
code E06 occurs at the selected interval.
After error codes E02 and E08, the device enters the
power-save mode to prevent over-discharging of the
rechargeable batteries. This mode can only be
terminated by turning the device off and on again.
Toggling Between Day and Night Phase
In the three measurement protocols, the day phase lasts
from 7 a.m. to 10 p.m. and the night phase from 10
p.m. to 7 a.m. On the display, the two phases are
represented by the symbols (day) or (night).
Patients whose day and night phases are different from
these predefined periods can push the button
twice to change from one phase to the other.
Audio Signal
If enabled (see page 18), the audio signal will be
emitted in the following situations:
-shortly after PHYSIO-PORT UP was switched on
-just before PHYSIO-PORT UP starts inflating the
cuff (during the day phase only)
-after PHYSIO-PORT UP has detected an erroneous
measurement
Note
If the measurement protocol was created with
PhysioPortWin and only one BP period has
been specified, switching from one phase to
the other will leave the measurement intervals
unchanged. They will always be the same. The
information "day phase" and "night phase" is
only used to identify the measurements.