PhysioFlow Q-LINK User manual

Manatec Biomedical
21, Rue du stade, Petit Ebersviller ▪57730 Folschviller ▪France
Tél : [phone] ▪Fax : [phone]
[e-mail]
First placing on the market: 18 January 2012
PHYSIOFLOW® Q-LINKTM
Service Manual
Tuesday, 27 November 2018 / V2.0

Manatec Biomedical
21, Rue du stade, Petit Ebersviller ▪57730 Folschviller ▪France
Tél : [phone] ▪Fax : [phone]
[email protected]
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Table of contents
1. General Information................................................................................................... 3
About this manual .......................................................................................................................................... 3
Contact ........................................................................................................................................................... 3
Symbols and Marks ........................................................................................................................................ 4
2. Device presentation ................................................................................................... 6
Interfaces........................................................................................................................................................ 7
Indications ...................................................................................................................................................... 8
Contraindications ........................................................................................................................................... 8
Precautions..................................................................................................................................................... 8
Functions ........................................................................................................................................................ 9
Warnings ...................................................................................................................................................... 10
3. Device Installation ................................................................................................... 12
Minimum configuration requirements......................................................................................................... 12
Installation.................................................................................................................................................... 13
Starting a measurement............................................................................................................................... 13
4. Identification and update of software ...................................................................... 14
Identification of the embedded software version........................................................................................ 14
Identification of the PhysioFlow® software V2 ............................................................................................ 14
Software update........................................................................................................................................... 14
5. Maintenance, Transport, Storage and Disposal ........................................................ 15
Maintenance ................................................................................................................................................ 15
Hardware ................................................................................................................................................. 15
Software................................................................................................................................................... 15
Storage and transport .................................................................................................................................. 16
Disposal ........................................................................................................................................................ 16
Appendix A: Accessories.................................................................................................. 17
Appendix B: Specifications .............................................................................................. 18
Environmental .............................................................................................................................................. 18
Electric and mechanical................................................................................................................................ 18
Electromagnetic compliance ........................................................................................................................ 19
Appendix C: Physiological parameters............................................................................. 22

Manatec Biomedical
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Tél : [phone] ▪Fax : [phone]
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Service Manual
PhysioFlow® Q-LinkTM
1. General Information
About this manual
This manual contains all the required information for installation, use, maintenance, transport and
storage operations for the PhysioFlow® Q-Link™system.
It can be used in one of the following way:
•with the PhysioFlow® Software V2.
•with a compatible third-party monitor. In this case it is not necessary to install the
PhysioFlow® software. For details on compatibility and instructions for coupling with such a
monitor please refer to the respective device IFU, handbook, or manual
This manual is for medical and biomedical staff involved in operating, configuring and handling the
system. To this extent initial agent training associated with the reading of the Q-LinkTM service
manual are sufficient for proper and safe use of the system.
Contact
Manatec Biomedical
21, Rue du stade, Petit Ebersviller
57730 Folschviller –France
Phone : [phone]
Fax : [phone]
Email : [e-mail]
Technical and commercial Information:
Manatec Biomedical
10 bis rue Jacob Courant
78300 Poissy –France
Tél : [phone]
Fax : [phone]
Commercial contact:
Email : [e-mail]
Technical support:
Email : [e-mail]

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Symbols and Marks
Symbols
Signification
Refer to instruction manual for the device.
Instruction manuals must be read.
PhysioFlow® Q-Link™is a CLASS II device according
to the IEC 60601-1 standard.
Connections linked to the patient are BF Type.
Device powered by a continuous current source.
« CE » mark followed by the notified
organization’s registration number. It ensures that
the device meets the essential requirements of
the European directive 93/42/CEE on medical
devices.
The Q-Link™product is classified according to the
WEEE directive (2012/19/EC) as reporting to
processing of electrical and electronic equipment.
Therefore, it can’t be treated as household waste.
Its recycling must be done in specialized recycling
centers. (cf. “Disposal” section)
Placement of the electrodes.
In the manual this symbol indicates that one or
several conditions could damage the equipment
itself and/or impact patient’s and/or user’s and/or
environment’s safety.
Important information to consider for an efficient
and optimized use of the system.

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Symbols
Signification
Symbol meaning « MANUFACTURER » followed
by:
Manatec Biomedical
21, Rue du stade, Petit Ebersviller
57730 Folschviller - France
Tel: [phone]
Fax: [phone]
Device must be protected from rain
Catalogue number
Serial number symbol
Symbol of the atmospheric pressure limits that the
device can be exposed to.
Symbol of the temperatures limits that the device
can be exposed to.
Symbol of the humidity limits that the device can
be exposed to.
Serial number affixed on the device
1213: Device type(Q-LinkTM)
YYMM: Production date (YY: year; MM: month)
0000: Product index (4 digits)

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2. Device presentation
PhysioFlow® Q-LinkTM is a noninvasive cardiac output evaluation technique, which provides
hemodynamic parameters by analyzing transthoracic impedance signal. It can be used at rest or
while exercising.
It consists in an electronic device, connected to a host interface (either a computer or a compatible
third-party monitor) through a USB link.
The electronic unit generates high frequency and low amplitude current, digitizes and processes the
ECG and modulated thoracic impedance signals. The ECG signal provides a time basis, a trigger for
the PhysioFlow algorithm. This ECG signal is not used for electrocardiography analysis
The PhysioFlow® software
1
or the compatible host performs electronic unit control, signal sample
collection, display of results, data storage and printouts.
1
For more information about the software, its installation and usage, refer to the following chapters or to the
appropriate third-party user manual

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Interfaces
The Q-Link™has a limited number of interfaces that makes the device intuitive and easy to use.
1. Ergonomic case makes it easy to handle.
2. USB cable to connect to the host.
3. Patient cable interface with mechanical mistake proof system.
4. LED indicator:
•When switched on: the device is tested, the indicator is orange. At the end of the
test, it changes to green if all the checks are correct. If not, the indicator changes to
red, indicating to the user to disconnect the device (the selected USB port fails to
deliver the required power and must not be used). The operator has to connect
PhysioFlow® Q-Link™to another USB interface or an external powered USB hub.
•Detection: When the software detects the connected Q-Link™ devices, the device
being detected trigger the following color sequence: red/orange/green.
2
1
3
4
5
6

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•When an acquisition is running: flashing green.
•Device powered and not used: constant green.
5. Device serial number.
6. Sticker with regulatory information (refer to section “Symbols and Marks”).
When the device is used, the operator must pay attention to the USB
cable between the Q-Link™and the host to prevent any risk of fall
and/or degradation of the system. Do not install the system in a
crowded area.
Do not open the enclosure.
The USB connector should only be used through a standard USB port
indicated by the following symbol :
Do not force the USB cable with another type of port/outlet.
In case of a communication error between the host and the Q-Link™
system, the USB interface has to be unplugged and re-plugged to restart
and reinitialize the device.
Indications
The PhysioFlow® System is indicated for use for patients who meet any of the following criteria:
•noninvasive diagnosis or monitoring of hemodynamics in patients with suspected or known
cardiovascular diseases,
•differentiation of cardiogenic from pulmonary causes of acute dyspnea,
•optimization of atrioventricular interval for patients with A/V sequential cardiac pacemakers,
•patients with need of determination for intravenous inotropic therapy,
•post heart transplant myocardial biopsy patients,
•patients with a need for fluid management.
Contraindications
The PhysioFlow® system is not intended for use on:
•patients with proven or suspected disease involving severe regurgitation of the aorta,
•patients with minute ventilation (MV) sensor function pacemakers,
•cardiac bypass patients while on a cardiopulmonary bypass machine,
•neonatal patients.
Precautions
Some clinical circumstances may impair accuracy of measurements, such as:
•tachycardia with heart rate above 250 bpm,
•untimely movement of neck,
•patients under 120cm (48 in.),
•patients under 25 Kg (67 lbs.),
•presence of aortic balloon pumps,
•presence of ultrafiltration systems,
•presence of pacemakers with external leads,
•open chest surgery,
•use of electrical cutlery and electrosurgical devices,
•morbidly obese patients, such as those weighting over 600 pounds.

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As per US FDA’s requirements, please take note of the following graph comparing PhysioFlow cardiac
output readings to Thermodilution cardiac output readings. It shows that 82% of readings are within
bounds (20% = margin of error of thermodilution).
Functions
PhysioFlow® System evaluates/computes the parameters listed in Appendix C.
K060387 PF CO vs. TD CO, (PF 4 of 4)
Manufacturer data
15/84 = 18% of data are outside bounds
0
2
4
6
8
10
12
0 2 4 6 8 10 12
TD CO (L/min)
Each PF reading was an average (avg.) of 4 consecutive readings, and each TD reading was an avg. of the best 3
of 4 readings, except that if the 2 extremes of the 4 TD readings were equidistant from the avg., the avg. of all 4
was used.
PF CO (L/min)
PF CO Identity line Upper bound Lower bound

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Warnings
▪The patient cable and the device are not designed to withstand defibrillation
shocks. When defibrillator is used, THE PATIENT CABLE MUST BE UNPLUGGED
FROM THE PATIENT. Do not let the device or patient cable be in contact with
the patient when the defibrillator is in use.
▪Prior to any measurement, ensure optimal signal quality is achieved by
oUsing PhysioFlow® PF-50 electrodes (cf. Appendix A). Manatec cannot
provide customer support if any other electrode is used.
oEnsuring the electrodes are not expired, damaged, dry, or used more
than 24 hours
oPreparing carefully patient’s skin (preferably using Nuprep® Skin
preparation gel)
oReferring to the instructions for attaching leads document
▪Do not use in an oxygen enriched environment or in the presence of
flammable anesthetics.
▪Sensors must be only positioned on the skin and nowhere else.
▪Disposal of this product and/or its accessories shall be made in accordance
with all locally enforced laws.
▪PhysioFlow® devices should not be used stacked with or close to any other
device. If it cannot be avoided, users must ensure that the PhysioFlow® device
function properly in this configuration.
▪The PhysioFlow® Q-LinkTM is a noninvasive hemodynamic evaluation system to
assess patient cardiovascular state using analysis of trans-thoracic
bioimpedance signals. It can’t be used alone to detect the cause of a given
physiological or pathological condition. Thus, PhysioFlow parameters and their
variations shall NEVER be used individually or out of context. They must be
combined with other parameters measured by other systems (BP, ECG, SPO2,
VO2, etc.), together with the clinical valuation of a physician, and never in lieu
and place of these.
▪PhysioFlow® devices need extra caution regarding electromagnetic
compatibility (EMC). It shall be setup and put on regarding the EMC
information specified in this service manual of the device.
▪Manatec considers itself responsible for effects on basic safety, reliability and
characteristics of any PhysioFlow® device only if:
oThe relevant room’s electrical installation complies with the
appropriate requirements, and if
oThe device is used in accordance with the operating instructions.
▪Any modification of any electro medical PhysioFlow® device is forbidden.

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▪PhysioFlow® Q-LinkTM is designed to be reliable, effective and mechanically
robust. However, it must be used with care.
▪PhysioFlow® devices have no particular protection against the penetration of
liquids. Do not allow liquids to get into the device.
▪Only patient cable provided by PhysioFlow® must be used. Any other use of
the patient cable is forbidden. Moreover, it can increase the electromagnetic
emissions and reduce the immunity of the device.
▪Patient cable PF07-BA-FILT MUST NOT be used while electro surgery tools are
operating since it can cause irreversible damages to the cable and the
PhysioFlow® Q-LinkTM unit. To prevent this situation to occur PF07-BA-FILT
can’t be used when PhysioFlow® Q-LinkTM is operated by the PhysioFlow®
software. However, it may be used with a compatible 3rd party monitor
providing it is not in the presence of electro surgery devices.
▪PhysioFlow® devices must not be sterilized.
▪FOR ACCURATE MEASUREMENTS, IT IS ESSENTIAL THAT THE OPERATOR
UNDERSTANDS THE DIFFERENCE BETWEEN ACCEPTABLE SIGNAL AND POOR
SIGNAL QUALITY. (refer to PhysioFlow® Software indications, or third-party
monitor manual).
▪The Q-LinkTM device must be operated on a non-tilted table.
▪Q-LinkTM is not intended to be in contact with the patient in normal use.
▪PhysioFlow Q-Link device does not claim any essential performance under
60601-1 standard

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3. Device Installation
Minimum configuration requirements
In order for the Q-LinkTM to work properly, the host (computer or third party medical system)
must have an available USB port to supply power to the device and to allow communication.
Minimal power source requirements are: 5V +/- 500mV, 300mA.
If the host is a computer/laptop, it must, as a minimum requirement, be
graded class II and comply with the relevant standard for information-
processing equipment (IEC 60950-1).
If the operator has to install/use the computer within the patient
environment2, the class II computer needs to comply with applicable medical
standards.
The USB standard requires minimum performances in terms of power (5V,
500mA max). However, the power delivered by the computer may not be
sufficient enough. In this case, the user may use a USB hub with an external
power supply.
For a correct installation and use of the software, the computer must have at least the following
characteristics:
•Operating system: Microsoft Windows 7, 8, 10
•2GHz dual core X86 or X64 Processor
•4GB RAM
•250MB Free hard disk space for installation
•Minimal size screen advised: 15‘’ (1280 x 768)
10GB free space on the hard drive is recommended to store monitoring data.
User has to make sure to have enough disk space for every measurement session!
If the disk space is less than 250MB, a warning indicates that the user should stop
using the software and free 10GB.
2
Volumetric area in which a patient can come into contact with medical equipment or contact can occur
between other persons touching medical equipment and the patient, both intentional and unintentional.

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Installation
PhysioFlow Software V2, open the setup of the PhysioFlow® software (available on the installation
CD, the USB key, or a link given by PhysioFlow® support [email protected]om). Follow the steps
listed on screen.
The Q-Link™is an USB « Plug and Play » device. This means the system is automatically detected and
installed when the USB is connected to the host.
If there are any problems or questions with the installation of the device, please contact technical
support: [e-mail].
Notes:
•PhysioFlow software 2.8.0 and later: Some features are subject to license. The user must
enter the license key in the software, then enter the activation code matching the license
and the computer. For this, please contact the local distributor to get a new license key, and
contact the technical support ([email protected]om) to get a new activation code.
•The PhysioFlow® Q-LinkTM for Deltex is not intended to be used with the PhysioFlow®
Software. Please refer to Deltex medical's CardioQ-ODM user manual for more information
regarding ODM / PhysioFlow® Q-LinkTM system configuration and use.
Starting a measurement
The procedure is given in the quick start guide provided with the device. As a complement, the
software shows to the user the recommendations to follow before the measurement starts.
It is important to strictly follow the instructions regarding skin preparation and
electrode placement listed in the document « Instructions for attaching leads».

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4. Identification and update of software
Identification of the embedded software version
The embedded software versions are set by the PhysioFlow® software installed on Windows. For
more information about embedded software version please contact Manatec Biomedical technical
service and give PhysioFlow® software V2 version number ([e-mail]).
Identification of the PhysioFlow® software V2
To know the version of the PhysioFlow® software installed on the computer, launch the software by
double clicking on the desktop shortcut “PhysioFlow Software”. Once the software is launched the
version can be read in the title bar as shown below:
Software update
The update of PhysioFlow software 2 is performed by an installation program. The installation of a
new software version replaces the existing version, but does not impact the data stored on the
computer.
The software detects automatically the devices at range/connected, and informs the operator when
the device needs a firmware update. The associated procedure is started when the user presses the
“Update Firmware”
Note: The firmware associated with the new PhysioFlow® software 2 is not compatible with the
previous generation v107 software

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5. Maintenance, Transport, Storage and Disposal
Maintenance
Hardware
The Q-LinkTM does not need any calibration or service operation during normal use.
The device and its accessories must be cleaned with a clean and dry cloth or lightly moistened with a
mixture of water and neutral soap. Do not connect the PhysioFlow® to the host while cleaning. If the
system has been contaminated by a patient’s blood or body fluids, clean and disinfect in the same
way as for the patient cables.
Life cycle of the product and its main accessories:
Patient cable
2 years from the date of first use
Q-Link™system
7 years from the date of first use
Electrodes
Single use only. Expiration date is printed on the pouch
Any maintenance and service operations must only be carried out by Manatec
Biomedical.
The enclosure must not be opened by the user (operator and technician).
Software
It is strongly recommended to back up the database regularly to prevent any data loss in case of PC
crash or hard drive failure. The instructions are available on the PhysioFlow software 2 knowledge
base.

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Storage and transport
Please refer to Appendix B for storage and transport environmental conditions.
When the PhysioFlow® is not used, please pack it in the foam padded case in which the device was
delivered.
Disposal
PhysioFlow® Q-Link™device: Do not throw away. Some components can be recycled according to
European Directive 2012/19/EC (WEEE).
The device must be sent to Manatec Biomedical Company or given to recycling specialized services
(contact local authorities’ services for further information about this matter).
Outside the European Union: Send the device back to Manatec Biomedical Company or comply with
the laws applicable in the country where the device was in use.
Return address: Manatec Biomedical
10, bis rue Jacob Courant
78300 Poissy
France
Host: Do not throw away. Please refer to the manufacturer’s instructions.
Electrodes: They are for single use only. Do not use for more than 24 hours on the patient. Once the
measurement is completed, please throw away according to the local law and/or procedure used in
the facility.

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Appendix A: Accessories
For any order or request concerning the accessories, please contact us at: [e-mail]
Designation
Patient cable PF07-BA
Patient cable PF07-BA-FILT (NOT TO BE USED WHILE
ELECTRO SURGERY TOOLS ARE OPERATING)
Electrodes PhysioFlow® PF-50
Abrasive gel Nuprep®
Foam padded case
PhyioFlow USB drive
Information leaflet about user instructions

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Appendix B: Specifications
Environmental
Use
Storage
Transport
Temperature
+10 –+34° C
-18°C and + 38°C
-18°C and + 38°C
Humidity
30% –70%
10% and 70%
10% and 70%
Pressure
700 hPa –1060 hPa
500hPa –1060 hPa
500hPa –1060 hPa
Electric and mechanical
The PhysioFlow® Q-Link™ is a Class IIa according to the European directive 93/42/CEE, Appendix IX.
Size
126 x 97 x 19 mm (enclosure only)
Weight
369g (patient and USB cables)
Length of the USB cable
298cm +/-10%
Electrical Supply
5V, 300mA
Applied parts
BF Type
Patient electric power
Sinusoidal, 66 kHz, 4.5mA peak to peak

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Electromagnetic compliance
Guidance and manufacturer's declaration - electromagnetic emissions
The PhysioFlow® Q-Link™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the PhysioFlow® Q-Link™ should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment- guidance
RF emissions
CISPR 11
Group 1
The PhysioFlow® Q-Link™ uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaration –electromagnetic immunity
The PhysioFlow® Q-Link™ is intended for use in the electromagnetic environment specified below.
The customer or the user of the PhysioFlow® Q-Link™ should assure that it is used In such an
environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 1 kV for
input/output lines
± 1 kV for
input/output lines
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

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Guidance and manufacturer’s declaration – electromagnetic immunity
The PhysioFlow® Q-Link™ is intended for use in the electromagnetic environment specified below. The
customer or the user of the PhysioFlow® Q-Link™ should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the PhysioFlow® Q-Link™ including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Disturbances
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
   

   
80 MHz to 800 MHz
   
800 MHz to 2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Disturbances
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3V/m
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.