St. Jude Medical QUANTIEN User manual

QUANTIEN™ Measurement System
Diagnostic Computer
C12787
Instructions for Use
State: Released Date: 2019.03.06 22:30 GMT

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed
to, St. Jude Medical or one of
its subsidiaries. ST.
JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St.
Jude
Medical, LLC and its related companies.
Pat.
http://patents.sjm.com
©
2019 St. Jude Medical, LLC. All Rights Reserved.
State: Released Date: 2019.03.06 22:30 GMT

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Contents
QUANTIEN™ Measurement System .......................................................................... 1
Introduction to the Instructions for Use (IFU) ............................................................. 1
Highlights Used.................................................................................................................1
Product Description................................................................................................... 2
Introduction ......................................................................................................................2
Intended Use ....................................................................................................................3
Indications for Use ............................................................................................................3
Contraindications...............................................................................................................3
Users................................................................................................................................3
Product Interface and Symbols ..........................................................................................3
Symbols Used on Product, Packaging, and IFU ..................................................................5
Remote Control Symbols and Functions..............................................................................7
Additional Devices and Accessories....................................................................................7
General Warnings, Precautions, and Safety Information.......................................................8
Graphical User Interface ..................................................................................................10
Indicator Lights and Sounds.............................................................................................12
Basic Setup Using Wi-Box™ AO Transmitter (Wireless AO Source)........................... 12
Install Wi-Box™ AO Transmitter .......................................................................................13
Unpack QUANTIEN™ Measurement System ....................................................................13
Mount QUANTIEN™ Main Unit in the Cath Lab ................................................................14
Room Configuration.........................................................................................................16
Measure FFR or RFR .............................................................................................. 17
Warnings and Precautions ...............................................................................................17
Live Window....................................................................................................................18
FFR/RFR Measurement Procedure...................................................................................19
Review Recordings.................................................................................................. 25
Review Window ...............................................................................................................25
Study Summary...............................................................................................................26
Review Recording............................................................................................................26
Export Data .....................................................................................................................28
Review Archived Studies ......................................................................................... 30
Archive Window...............................................................................................................30
Export and Delete Files in Archive ....................................................................................31
Settings................................................................................................................... 32
System Settings Overview.................................................................................................32
Room Setup ....................................................................................................................32
Regional Settings.............................................................................................................35
User Settings...................................................................................................................35
Security Settings..............................................................................................................36
Connections ....................................................................................................................37
Network Configuration .....................................................................................................41
Display Settings...............................................................................................................44
Service............................................................................................................................46
Demo Mode ....................................................................................................................46
Troubleshooting ...................................................................................................... 47
On Screen Messages .......................................................................................................47
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Tracing EM Interference...................................................................................................53
Troubleshooting Tables ....................................................................................................55
Maintenance...........................................................................................................67
Remote Control Battery ....................................................................................................67
System Backup Battery....................................................................................................68
Disposal ..........................................................................................................................68
Cleaning..........................................................................................................................68
Preventative Maintenance Schedule .................................................................................68
Leakage Current Measurement.........................................................................................69
Testing PW IN .................................................................................................................70
Testing PW OUT and Associated Monitor Channel.............................................................71
Testing AUX IN 1 and Associated Monitor Channel............................................................72
Testing AUX IN 2 and Associated Monitor Channel............................................................73
Testing AUX OUT 1 & 2 and Associated Monitor Channel ..................................................73
Test Probes .....................................................................................................................74
Leakage Adapters ............................................................................................................75
Service or Repair .............................................................................................................75
Technical Specifications ..........................................................................................75
Pressure Measurement ....................................................................................................75
Electrical Specifications....................................................................................................75
Specifications Interfaces...................................................................................................75
Dimensions .....................................................................................................................77
Environmental Conditions.................................................................................................77
Isolation Diagram.............................................................................................................78
File Formats ....................................................................................................................79
Compliance with Regulatory Requirements ..............................................................79
Compliance with Standards and Directives........................................................................79
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions..............................80
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity...............................81
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and QUANTIEN™ System ...........................................................................83
Warranty Disclaimer ................................................................................................84
Australian Warranty .................................................................................................84
State: Released Date: 2019.03.06 22:30 GMT

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QUANTIEN™ Measurement System
Introduction to the Instructions for Use (IFU)
This IFU contains both the instructions for use for the operator and technical information
including installation and maintenance instructions.
This IFU describes the handling of the QUANTIEN™ measurement system. For operation of the
QUANTIEN measurement system, other devices need to be connected. Consult the IFU for each
of these devices for details on handling and safety information.
NOTE: Pictures are shown for example only.
Highlights Used
Bold font is used in the IFU to identify the names of buttons, menus, and windows, and is also
used for some subheadings.
Warnings, cautions and notes are used in the following way:
WARNING: The personal safety of the patient or user may be involved.
Disregarding this information could result in injury.
CAUTION: These instructions point out special service procedures or precautions
that you must follow to avoid damaging the device.
Note: This provides information you might find especially useful or information that
facilitates maintenance or clarifies important instructions.
The following abbreviations and terms are used in this IFU:
Table 1. Abbreviations used in this IFU
Abbreviatio
n
Description
AO
Aortic Pressure
Cath lab
Catheterization laboratory
CF Cardiac Floating
PCI
Percutaneous Coronary Intervention
FFR
Fractional Flow Reserve (Pd/Pa, measured at maximum hyperemia)
HRS
Hemodynamic recording system (Hemodynamic recording system)
IFU Instruction for Use
Pa
Proximal Pressure
Pd
Distal Pressure
PW
PressureWire™ guidewire
RFR Resting Full-cycle Ratio
Study As used in this IFU a study consists of all FFR measurement recordings for one
patient on the same occasion/procedure
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Product Description
Introduction
Figure 1. QUANTIEN™ Main Unit with Table Stand and Remote Control
The QUANTIEN™ measurement system is a diagnostic computer designed to record, compute,
display and store data from PressureWire™ guidewire and other external transducers. The
information is displayed as graphs as well as numerical values on the screen. Data includes, but is
not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve
(FFR), and data from ECG.
Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure (Pd) to aortic
pressure (Pa), measured during hyperemia. It provides the maximal blood flow in the presence of
a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation
that the stenosis was not present. Pd/Pa at rest is the ratio of distal coronary arterial pressure to
aortic pressure measured at resting conditions. Resting Full-cycle Ratio (RFR) is the ratio of Pd to
Pa at a point in the cardiac cycle where the Pd/Pa ratio is minimal. RFR is designed to be used at
rest and, in contrast to Pd/Pa at rest, is a sub-cycle metric.
These physiological parameters are measured when the QUANTIEN™ measurement system is
used with the manufacturer’s distal intracoronary pressure transducer and a proximal aortic
pressure transducer.
The physician may use the FFR, Pd/Pa at rest and RFR parameters, along with knowledge of
patient history, medical expertise and clinical judgment to determine if therapeutic intervention is
indicated.
Information on screen can also be transferred to an external HRS or to an external video monitor.
Recorded procedures can be viewed on a PC for post-procedural review and analysis with
application specific viewing software installed, such as RadiView™ software.
Additional functions let you import a patient work list from the hospital DICOM1‡ system, export
recorded measurement data to DICOM or to an external server location or save it to a USB
memory stick.
1DICOM is a registered trademark of the National Electrical Manufacturers Association for its standards publications relating to
digital communications of medical information.
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Intended Use
The QUANTIEN™ measurement system is intended for use in catheterization and related
cardiovascular specialty laboratories to compute and display various physiological parameters
based on the output from one or more electrodes, transducers or measuring devices.
Indications for Use
The QUANTIEN™ measurement system is indicated to provide hemodynamic information for use
in the diagnosis and treatment of coronary or peripheral artery disease.
The QUANTIEN measurement system is intended for use in the catheterization and related
cardiovascular specialty laboratories to compute, and display various physiological parameters
based on the output from one or more electrodes, transducers, or measuring devices.
Contraindications
The device has no patient alarm functions. Do not use it for cardiac monitoring.
Users
Normal operation: The QUANTIEN™ measurement system should be handled by or supervised
by a physician with training in catheterization laboratory procedures.
Preventative maintenance: Hospital technician
Installation: Hospital technician/IT personnel, St. Jude Medical sales representative/technician.
Product Interface and Symbols
The QUANTIEN™ measurement system includes a main unit with a touch screen user interface
and several input/output ports, a remote control, a power cable and an ethernet patch cable with
isolator.
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Figure 2. QUANTIEN™ Interface
Table 2. QUANTIEN™ Interface and Port Symbols
No.
Symbol or marking
Explanation
1 N/A QUANTIEN™ main unit
2 N/A Display – touch screen
3 N/A Power cable with power supply unit
4 N/A Indicator light, power supply
5 N/A Patch cable and isolation box
6 PressureWire™ IN PressureWire IN on PressureWire interface – Pd signal from
PressureWire guidewire (white sleeve). Connection to applied part.
7 AUX IN 1 AO signal from cath lab recording system (yellow sleeve)
8 AUX IN 2 ECG signal from HRS (black sleeve)
9 AUX OUT 1 Pa, Pd or reference signal output (grey sleeve)
10 AUX OUT 2 Pa, Pd or reference signal output (grey sleeve)
11 N/A Heat sink and connection block for mounting bracket (VESA
standard 75 x 75 mm and 100 x 100 mm)
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Table 2. QUANTIEN™ Interface and Port Symbols
No.
Symbol or marking
Explanation
12 PressureWire™ OUT PressureWire OUT on PressureWire interface – Pd signal to external
monitor (green sleeve). Connection to applied part.
13
DVI-I output – video display/monitor
14
USB port – Memory stick, data export, software upgrade
15 Ethernet – network connection
16 On/Off switch
17 N/A Remote control
18 N/A Slot for storing remote control
Symbols Used on Product, Packaging, and IFU
The following symbols may be found on the product or product label:
Symbol
Description
Follow instructions for use. (Symbol appears blue on product labeling.)
Affixed to this device in accordance with European Council Directives
2002/96/EC and 2006/66/EC.
These directives call for separate collection and disposal of electrical and
electronic equipment. Sorting such waste and removing it from other
forms of waste lessens the contribution of potentially toxic substances
into municipal disposal systems and into the larger ecosystem.
Intertek Safety Agency Certification Mark
Canada 310
This device complies with RSS-310 of Industry Canada. Operation is
subject to the condition that this device does not cause harmful
interference.
Caution
Defibrillation-proof Type CF equipment
Manufacturer
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The following symbols may be found on the product or product label:
Symbol
Description
Catalog number
Serial number
Lot Number
Consult instructions for use
Follow instructions for use on this website
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
Quantity
Date of Manufacture
Keep dry
Temperature limitations
Humidity limitation
European conformity, affixed according to the relevant provisions of MD
directives 93/42/EEC and 2011/65/EU, and RE directive 2014/53/EU
Annex II. Hereby, St. Jude Medical declares that this device complies
with the essential requirements and other relevant provisions of these
directives.
The full text of the European Union RE directive 2014/53/EU declaration
of conformity is available at the following internet address:
www.sjmglobal.com/euconformity.
Diagnostic Computer
Medical equipment
Finished good
Authorized Representative in the European Community
State: Released Date: 2019.03.06 22:30 GMT