Philips 830230 User Manual Brochure 452299123501 Xper Flex Cardio Sell Sheet Spec

User Manual: Philips 830230 brochure Xper Information Management (Xper IM) with Xper Flex Cardio Cardiovascular workflow solution830230

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Flexibility and clinical
decision support
Xper Flex Cardio with Xper Information Management
Xper Flex Cardio
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3
Contents
1 Introduction 4
2 Intended use 5
Xper Flex Cardio
Physiomonitoring system 5
Xper Information Management 5
3 Monitoring parameters 5
Standard 5
Optional 5
4 Environmental and usability
enhancements 6
5 Harmonious Philips connectivity 6
6 Exclusive functionality 7
7 ECG waveform analysis (DXL Algorithm) 7
Expanded diagnostic capabilities 7
Gender-specific ECG interpretation 8
STEMI-CA for identification of Culprit Artery 8
ST Maps 8
ST Maps draw attention to abnormalities 8
8 Supports FFR technology 9
9 Enhanced hemodynamics and alarm controls 9
10 Clinical and operations workflow modules 10
Charting 10
Arterial trees 10
Hemodynamic calculations 10
Vitals capture 10
Scheduler 10
Inventory 10
Billing 11
Transcription 11
Data analysis 11
Registries 11
Custom forms 11
Whiteboard Viewer 11
Xper Connect and hospital interface 11
Data center 11
11 Technical specifications 12
General specifications 12
ETCO2 module – model:
Philips M2741A Sidestream CO2 sensor 12
ETCO2 module – model:
Philips M2501A Mainstream CO2 sensor 12
NIBP module 12
SPO2 module 13
Body temperature module 13
Invasive blood pressure 13
Cardiac output 13
ECG 13
Respirations 13
Physiomonitoring alarms and alarm ranges 14
Patient care consumables 15
Philips provides patient care and clinical
informatics solutions that improve the
clinical practice and simplify the workflow.
The Xper Flex Cardio Physiomonitoring
system applies these values, putting clinical
IT to work through a space-saving design,
Fractional Flow Reserve (FFR) support,
advanced electrocardiogram (ECG) analysis
tools, and a host of other features that deliver
high quality physiomonitoring – before,
during, and after interventional procedures.
This product specifications document contains
a complete description of Xper Flex Cardio
Physiomonitoring and the enhanced Xper
Information Management (Xper IM) software.
Xper Flex Cardio Physiomonitoring system
Xper Flex Cardio Physiomonitoring system is a hemodynamic
monitoring solution for cardiac monitoring in hospitals and
clinics where interventional procedures are performed in cardiac
catheterization and electrophysiology (EP) labs, as well as
interventional radiology. Xper Flex Cardio brings workflow-
enhancing features as well as advanced clinical decision support
tools to the interventional workspace. The small, space-saving design
provides flexible workflow inside the lab while offering scalability to
meet ever-evolving clinical needs.
1. Introduction
Key advantages
• Comprehensive hemodynamic analysis package and connected
with Xper IM
• Streamlined FFR workflow makes it easy to perform FFR
measurements, from acquisition to automatic data entry onto reports
• Patented DXL Algorithm facilitates Culprit Artery Detection,
ST Maps and Critical Values
• Patient data connection with Philips image guided therapy systems
such as Azurion
• Philips harmonized patient cables allows for reuse of cables
from IntelliVue monitors
• Space-saving design delivers mounting and positioning flexibility
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1. Introduction 2. Intended use
3. Monitoring parameters
Xper Flex Cardio
Physiomonitoring system
The physiomonitoring system is intended for use by professional
healthcare providers for complete physiologic and hemodynamic
monitoring. The system may be used to display and analyze
surface ECG, respiration, invasive pressure, pulse oximetry (SpO2),
end tidal CO2 (ETCO2), FFR, non-invasive blood pressure (NIBP),
surface body temperature, and thermal cardiac output. The
system also provides for clinical data acquisition, medical image
and data processing, and analytical assessment. The system
is indicated for use in the following areas: cardiology, cardiac
catheterization, electrophysiology, radiology, invasive radiology,
and other areas where cardiac monitoring may be required. The
system is not intended to be used in the proximity of magnetic
resonance imaging. The data may also be acquired from and
sent to other devices, such as physiological monitoring systems,
information management systems, image acquisition and storage
devices, and other medical devices.
User-adjustable alarms (both visual and audible) available
in the system alert the operator to anomalous occurrences to
facilitate timely responses. Use of the system is not intended
where unattended patient monitoring is desired, or in situations
where arrhythmia detection is required.
Standard
• 12-lead ECG capability
• 4 invasive blood pressure channels
• Non-invasive blood pressure (NIBP)
• Pulse oximetry (SpO2)
• Respiration rate
• Body surface temperature
• Thermodilution cardiac output
Xper Information Management
The information management system is intended for use under
the direct supervision of a healthcare practitioner for acquiring,
displaying, trending, storing, and transmitting various types of
data, such as physiologic/hemodynamic, clinical, medical image,
and other related data. The system is capable of processing/
analyzing information, such as multi-channel ECG signals,
and performing other data management functions, such as
creating reports. Data may be acquired from and/or sent to other
devices, such as physiological monitoring systems, information
management systems, image acquisition/storage devices,
and other medical devices.
The system is indicated for use in the following areas: cardiology,
cardiac catheterization, electrophysiology, radiology, invasive
radiology, and surrounding areas where access to the information
is needed.
The system consists of modules and may be entirely a software
offering or a hardware/software offering. It is intended for use
on standard computer systems and does not require proprietary
hardware. The solution is available as a single module or
combination of modules, or may function as a standalone system.
The system is capable of receiving and displaying user-adjustable
alarms (both visual and audible) available in the system, which
alert the operator to anomalous occurrences and facilitate timely
responses. Use of the system is not intended where unattended
patient monitoring is desired, or in situations where arrhythmia
detection is required.
The system provides the ability to transmit patient data files
for storage, viewing and analysis at distributed locations via
the intranet or internet, or may function as a stand-alone device.
Optional
• Philips DXL Algorithm (ECG analysis,
STEMI-CA, ST Maps and Critical Values)
• FFR – with approved third-party vendors
• End tidal CO2 (capnography) mainstream
and sidestream
• Philips has designed a small form factor physiomonitoring
system that enables flexible and easy positioning within
the interventional lab environment or outside the lab where
cardiac monitoring is needed
• The Xper Flex Cardio signal acquisition device is one-sixth
the size (14.6%) and one-quarter the weight (22%) of the Xper
Physiomonitoring 5 device
• Xper Flex Cardio has a VESA (Video Electronics Standards
Association) mounting capability, an industry-wide standard
that enables a variety of positioning options
Xper Flex Cardio is compatible with a range of Philips cables and
accessories that are currently used on the Philips IntelliVue patient
monitoring systems. This helps streamline clinician workflow so
the focus can be on patient care.
4. Environmental and usability
enhancements
5. Harmonious Philips connectivity
• Compatibility with the VESA standard allows for mounting in
multiple locations, such as on an X-ray table rail inside a cath
lab, an articulating arm, a roll cart that can be used in multiple
cath labs, or flush against a wall by the bedside in a patient
monitoring area
• Keeping the signal acquisition device off the floor increases
available floor space within the procedure room
• Smart design enables users to simply swap the device in case
maintenance is required, allowing them to quickly and easily
continue their work without major disruption to workflow
• Simplified hemodynamic recording control via intuitive
graphical user interface
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6. Exclusive functionality
Xper Flex Cardio brings the power of 12-lead ECGs to
interventional environments. Using 12 leads for post-procedure
ECGs enables rapid and confident assessment of cardiac
symptoms. Xper Flex Cardio also supports standard 12-lead
ECG monitoring, recording, and analysis.
In conjunction, Philips-exclusive DXL Algorithm incorporates
tools that provide quantitative information for evaluation of
ST Elevation Myocardial Infarction (STEMI). The integration of
the DXL Algorithm into Xper Flex Cardio extracts quantitative
criteria for Culprit Artery identification and displays the spatial
orientation of the ST-segment abnormalities in 3D polar maps,
which can help improve patient care in the cath lab.
7. ECG waveform analysis
(DXL Algorithm)
The Philips DXL ECG Algorithm, developed by the Advanced
Algorithm Research Center, uses sophisticated analytical
methods for interpreting resting ECG. The DXL Algorithm
analyzes up to 12 leads of simultaneously acquired ECG
waveforms to provide an interpretation of rhythm and
morphology for a wide variety of patient populations.
The algorithm reflects new recommendations, such as
the 2007 AHA/ACCF/HRS Recommendations, Part II1 and
the 2009 AHA/ACCF/HRS Recommendations, Part VI2 for
the Standardization and Interpretation of the ECG.
The ECG Analysis Module provides an analysis of the amplitudes,
durations, electrical axis, ST Mapping, and morphologies of
the ECG waveforms and associated rhythms. ECG waveform
analysis is based on standard criteria for interpretation of these
parameters. The ECG analysis is a tool
to assist the physician in making a clinical diagnosis in
conjunction with the physician’s knowledge of the patient,
the results of the physical examination, and other findings,
and is not intended to be a substitute for interpretation by
a qualified physician.
Expanded diagnostic capabilities
The Philips DXL ECG Algorithm goes beyond traditional 12-lead
interpretation of the resting ECG. It also provides for incremental
diagnostic capabilities not associated with analysis programs of
the past:
• ST Maps that provide a visual representation of ST deviations
in frontal and transverse planes, responding to the 2009
AHA/ACCF/HRS Recommendations, Part VI2 for the
Standardization and Interpretation of the ECG
• Updated criteria based upon the latest clinical research.
Examples include the addition of “acute global ischemia” and
incorporation of updated gender-specific STEMI criteria, as
documented in the 2009 AHA/ACCF/HRS Recommendations
• STEMI-CA (Culprit Artery) criteria that suggests the probable
site of an occlusion, consistent with the 2009 AHA/ACCF/HRS
Recommendations
• Critical Values that highlight conditions requiring immediate
clinical attention
• LeadCheck program that identifies 19 possible lead reversal
and placement errors during ECG acquisition
• Updated statements that reflect the 2007 AHA/ACCF/HRS
Recommendations
STMI
decision
suppport
tools
12 standard leads
ST Maps
STEMI criteriaSTEMI-CA
100 µV
0.30mV0.30mV
aVL
0.11
I
0.06
-aVR
-0.01
II
-0.08
III
-0.15 aVF
-0.12
+
+
+
+
+
+
0.30mV0.30mV
V1
+.3
+
+
+
+
+
+
V2
+.3
V3
+.3
V4
+.3
V5
0.27
V6
0.07
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Gender-specific ECG interpretation
As cardiovascular medicine continues to advance, there
has been continued learning regarding the physiological
differences between men and women. Gender-specific criteria
are not new to Philips. They have been incorporated into the
multi-lead algorithms since 1987 and have been enhanced
continually based upon the latest research and guidelines.
For example, the DXL Algorithm applies gender, lead, and age
limits to aid in the detection of acute MI. Based upon the 2009
recommendations, STEMI criteria are subject to reduced ST
thresholds in women. The algorithm also uses gender-specific
axis deviation and MI criteria, Cornell gender-specific criteria
for detection of left ventricular hypertrophies, and Rochester
and Rautaharju criteria for the detection of prolonged QT.
Application of these gender-specific criteria results in an
ECG interpretation that helps clinicians assess the cardiac state
of male and female patient.
STEMI-CA for identification
of Culprit Artery
If STEMI criteria are met, the DXL Algorithm’s STEMI-CA
criteria helps you identify the likely Culprit Artery or probable
anatomical site causing the functional ischemia. This may
have prognostic significance as well as help to pinpoint the
offending lesion when multiple obstructions are present,
and can thus be used to enhance the treatment approach
in the cath lab.
Specific anatomic sites can include the following
coronary arteries:
• Left anterior descending artery (LAD)
• Right coronary artery (RCA)
• Left circumflex artery (LCx)
• Left main or multi-vessel disease (LM/MVD)
ST Maps provide rapid visualization of the degree
of ST abnormalities
ST Maps
The 2009 AHA/ACCF/HRS document recommends the display
of the spatial orientation of ST-segment deviations in both
frontal and transverse planes. Xper Flex Cardio can display
patented ST Maps in both planes to provide for rapid visual
assessment of the degree of ST abnormalities (see Figure 1). The
maps are plotted in “Cabrera sequence” to reflect the anatomical
orientation. This presentation, previously available only on
Philips IntelliVue patient monitors, provides distinct patterns for
different anatomic sites of infarcts, global ischemia, pericarditis,
and other conditions that are readily seen using such maps.
1 AHA/ACCF/HRS Recommendations for the Standardization and Interpretation
of the Electrocardiogram, Part II: Electrocardiography Diagnostic Statement
List. J Am Coll Cardiology. 2007;49:1128-135.
2 AHA/ACCF/HRS Recommendations for the Standardization and Interpretation
of the Electrocardiogram, Part VI: Acute Ischemia/Infarction. Circulation.
2009;119:e262-e270.
0.30mV0.30mV
aVL
0.11
I
0.06
-aVR
-0.01
II
-0.08
III
-0.15 aVF
-0.12
+
+
+
+
+
+
0.30mV0.30mV
V1
+.3
+
+
+
+
+
+
V2
+.3
V3
+.3
V4
+.3
V5
0.27
V6
0.07
ST Maps draw attention to abnormalities
Early detection of STEMI shortens “discovery to treatment”
times. The DXL Algorithm enables Philips patented ST Maps,
a graphical indication of ST elevation or depression. Philips ST
Maps meet the 2009 AHA/ACCF/HRS Recommendation that
the spatial orientation of ST-segment deviations be displayed
in both frontal and transverse planes. The maps provide distinct
patterns for different anatomic sites of acute infarcts, region
of ischemia, and other conditions, helping physicians assess
a patient’s condition before and during the procedure. After the
intervention, ST Maps provide visual verification of the results,
allowing assessment of the extent of the infarct and the success
of the stent in alleviating the condition.
9
FFR is a technique that has been shown to be beneficial in
assessing ischemia and in determining if a physician should
deploy a coronary stent as part of the patient’s treatment.
Xper Flex Cardio allows for interfacing with FFR devices, allowing
users to perform integrated FFR measurements. FFR is a lesion-
specific physiological index determining the hemodynamic
severity of intracoronary lesions.
8. Supports FFR technology
Within Xper Flex Cardio, a single click launches the FFR function
which allows users to identify the appropriate anatomical site
and capture FFR data, display the measured result in real time,
and store the measurement as part of the hemodynamic record.
These measurements can be used to automatically populate
a physician’s final report.
9. Enhanced hemodynamics
and alarm controls
Intuitive icon-based controls for hemodynamic monitoring
have been designed and implemented for simplified usability.
Enhancements help users navigate to set-up screens to
modify specific parameters and alarm settings. The icons that
activate various functionality or commands also display a text
bubble when a cursor is placed over them, helping users learn
the functionality.
The alarm capability in Xper Flex Cardio supports the IEC
60601-1-8 standard for alarms
Hemodynamic
functions and
configurations
Xper Flex Cardio monitoring screen
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10. Clinical and operations
workflow modules
IntelliSpace Cardiovascular integration
Xper IM is integrated with Philips IntelliSpace Cardiovascular.
This allows a user to access Xper IM directly from the Cardiology
Timeline and Worklists applet and launch into study context as
well as import images from IntelliSpace Cardiovascular into the
Xper IM report for inclusion.
Charting
The Charting Module allows quick and easy procedure
charting, where users can create custom menus to refine
workflow. Procedural charting is integrally connected
to transcription and statistical reports, as well as other
modules throughout the application. In addition, entries
and modifications to charting are tracked, so that users
can perform audits if discrepancies arise.
Arterial trees
The Arterial Trees Module allows a physician to create a
graphic representation of a patient’s cardiac or peripheral
arterial anatomy. The arterial trees allow users to indicate
areas of disease, collaterals and bypass grafts, interventions
performed, and other diagnostic data, such as anatomical
aberrations. The data from the tree is automatically placed in
the appropriate charting menu and can be included in a report
or queried at a later time. Operators may use the provided
templates or replace any or all of them with a preferred set.
Hemodynamic calculations
The Hemodynamic Calculations Module features a screen
that contains the invasive pressure and cardiac output data
that is collected during a procedure. The collected data is used
to perform calculations, such as vascular resistance, intracardiac
shunting, and valve stenosis. The calculations are performed
automatically as samples are captured, and are recalculated
when samples are edited using the waveform review screen.
Users also enter oxygen saturation data into the hemodynamics
screen. Hemodynamics screens correspond to monitoring
conditions. When users record an initial pressure sample
in a condition on the monitoring screen, a hemodynamics
screen is created to match that condition. Any data from
subsequent samples taken in that condition is recorded
on the corresponding hemodynamics screen.
Vitals capture
The Vitals Capture Module is an automatic function within
Xper IM. The Vitals Capture Module can be set to collect and
chart patient vital signs at intervals of 2 to 60 minutes. Once
vitals have been captured, users can display the data elements
in either a Vitals Record or a Sedation Flowsheet format. This
module does not control setting the actual device parameters
for vital signs capture, but merely the recording of the results.
The actual parameters are set via the Hemodynamic Control
Software. Additionally, an interface between Xper IM and PIIC iX
allows automatic transfer of vital signs from IntelliVue monitoring
units in the pre- and post-holding areas.
Scheduler
The Scheduler Module allows for the scheduling of patient
studies for specific dates and times based on availability
of staff and resources.
Inventory
The Inventory Module helps manage inventory. Existing
inventory data can be imported from an Excel® spreadsheet
and HL7 inventory master lists. The Inventory Module is tightly
integrated with Charting, Billing, and Reporting modules.
Inventory items are automatically deducted, modified, and
updated in the background. Users can store data such as
reference codes, barcodes, catalog numbers, pricing information,
manufacturer, vendor, serial number and lot numbers (including
compatibility with GS1-128 barcodes). The Inventory Module
supports bi-directional interfaces to other third-party inventory
systems. Bi-directional inventory interface provides real-time
updates available via HL7 to import materials data. MFN-M16
record is our standard, but can be configured for any HL7.
Another feature includes building and viewing orders. Built-in
inventory reports can be run quickly to display items below par,
item location, items approaching expiration, and aging reports.
Xper IM offers a highly configurable cardiovascular workflow solution for the
cath lab. This innovative software suite presents a variety of innovations for
reporting, scheduling, inventory, and intelligent data management. With tools
that enhance efficiency on multiple levels, the solution improves and simplifies
workflow for cardiology professionals. It includes:
11
Billing
Xper IM Billing module provides association of procedures with
diagnostic codes, enabling compliance with regulations for
meaningful use criteria and reimbursements. Xper IM provides a
billing interface to send financial transactions from Xper IM. The
billing interface sends collected charges to a billing system using
HL7 or hospital-defined flat file (compatible with third-party
systems such as Medi-Tech). Additionally, Xper IM supports (BAR-
billing administration record) HL7 billing transactions.
Transcription
The Transcription Module offers report templates that can be
edited, modified, and customized. With the Builder, users can
reduce data redundancies by saving sections of a template that
can be easily placed into another template report, saving valuable
time. Users can also designate default reports based on the
selected procedure. This module permits selection of coronary
trees, images, and waveforms included in reports. For users of
Nuance PowerScribe 360, Xper IM offers automatic integration
and incorporation of text from dictation in Nuance Power Scribe
360 into the Xper IM transcription reports. All reports can contain
electronic signatures and can be stored as a PDF when finalized.
Data analysis
The Data Analysis Module can query the database of
information stored in the system. Data can be transformed
into accessible and valuable information to create clinical and
statistical reports. Users can build queries to filter, group, and
sort data elements to create graphical bar graph, pie chart,
matrix, and list displays. The queried information can
be exported from the system. Users can also analyze the data
of the Xper IM database using the Advanced Analytics tool in
IntelliSpace Cardiovascular.
Registries
The Registries Module allows for the collection of data that is
relevant for several purposes, including reporting to registry
databases such as the American College of Cardiology National
Cardiovascular Data Registry (CathPCI, ICD, etc.). Registry data
can be exported to a third-party vendor for submission.
The module also allows the capture and reporting of information
for local, smaller registries, such as various state registries.
Custom forms
The Custom Forms Module allows users to capture data that is
uniquely important to their institutions. Creating custom forms
also allows users to organize the data concisely. The fields
become part of the database, so scrapers* can be built to make
data collection quick and easy. In addition, the data fields can be
queried. Users can create as many forms as they need, and can
create forms for different modalities.
Whiteboard Viewer
The Whiteboard Viewer Module is a utility module that displays
patient status and location during procedures. Users can change
status to pre-procedure, during-procedure and post-procedure.
The module provides tools to enhance communication among
family members, physicians, and staff.
IntelliBridge Enterprise**
IntelliBridge Enterprise is a single engine for enterprise
interoperability; it allows two-way data exchange between
cardiology informatics products (IntelliSpace Cardiovascular,
Xper IM) and hospital’s clinical and administrative systems;
Embracing industry standards such as HL7, DICOM, and IHE,
IntelliBridge Enterprise helps to reduce work required by your
IT department.
IntelliBridge Enterprise for Xper IM supports interface installations
with ADT, query ADT, billing, orders, outbound inventory, real time
lab values, results, discreet clinical data, electronic medical record,
DICOM worklists and MPPS.
Data center
Xper IM Data Center is the central server designed to give users
with administrative rights access to system functions. From here,
users can access:
• Software updates: Data Center manages and performs
automatic database updates
• System auditing tools: users can review all auditing logs
to verify that the system is performing optimally
• Client and server updates: this feature provides client and
server automated data replication. If a user builds a menu
in Xper IM and saves it, that menu will be distributed to
all stations
• Security: Data Center provides the user with access to Xper IM’s
robust, innovative security features
• Administrative features: our convenient administrator toolset
allows management of user rights and system configurations
* Data scrapers are powerful tools that enable users to collect data efficiently,
and reduce duplication of work and errors in data entry. The functionality of
the data scrapers has been expanded to allow data to be copied from one field
to another, as well as to be copied from charting to related fields in the patient
demographics screen, registry screens, and transcription reports.
** Xper Connect will be phased out as all interfaces become available with
IntelliBridge Enterprise.
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11. Technical specifications
ETCO2 module – model: Philips M2741A Sidestream
CO2 sensor
Specification
Standard ISO 21647
Measurement range 0 – 150 mmHg, 0 – 20 kPa
(at 760 mmHg)
Accuracy 0 – 40 mmHg ± 2 mmHg
41 – 70 mmHg ± 5% of reading
71 – 100 mmHg ± 8% of reading
101 – 150 mmHg ± 10% of reading
Note: All specifications are ± 12%
for respiration rates above 80 BPM
Sample flow rate 50 ml/min ± 10 ml/min
Respiratory rate Range 0 – 150 ipm
Accuracy ± 1 breath
Initialization time Full specification within 2 minutes,
waveform data in less than
20 seconds at ambient
temperature of 25° C
Calibration No routine user calibration required
Water resistance (sensor) IPX4 Splash-proof
Operating temperature 0 – 40° C, 10 – 90% RH,
non-condensing
Storage temperature 0 – 70° C, < 90% RH,
non-condensing
ETCO2 module – model: Philips M2501A Mainstream
CO2 sensor
Specification
Standard ISO 21647
Measurement range 0 – 150 mmHg, 0 – 20 kPa
(at 760 mmHg)
Accuracy 0 – 40 mmHg ± 2 mmHg
41 – 70 mmHg ± 5% of reading
71 – 100 mmHg ± 8% of reading
101 – 150 mmHg ± 10% of reading
Initialization time Full specification within 2 minutes,
waveform data in less than
20 seconds at ambient
temperature of 25° C
Calibration No routine user calibration required
Water resistance (sensor) IPX4 Splash-proof
Operating temperature 0 – 40° C, 10 – 90% RH,
non-condensing
Storage temperature 0 – 70° C, < 90% RH,
non-condensing
NIBP module
Specification
Standard IEC 60601-2-30
Measurement method Oscillometric, employing stepwise
pressure deflation
Modes Manual or automatic
Manual: manometer Accuracy check of NIBP pressure
Automatic Host can select intervals of 1, 2, 3,
4, 5, 10, 15, 30, 60, 90 minutes
STAT Typical measurement time in less
than 20 seconds
Five-second pause between
measurements
Runs in continuous STAT mode
until user intervention
Blood pressure range
(adult/pediatric)
Systolic: 35 – 255 mmHg
Diastolic: 15 – 215 mmHg
MAP: 20 – 235 mmHg
Pulse: 30 – 240 BPM
Blood pressure range
(neonatal/infant)
Systolic: 35 – 135 mmHg
Diastolic: 15 – 105 mmHg
MAP: 20 – 115 mmHg
Pulse: 40 – 240 BPM
Pressure and pulse
rate resolution
Pressure resolution: 1 mmHg
Heart rate resolution: 1 BPM
Redundant hardware
over pressure limits
Adult: 300 mmHg +/- 10%
Neonatal: 150 mmHg +/- 10%
Pressure transducer accuracy± 3 mmHg over the full range
(0 – 270 mmHg)
To maintain accuracy, it is
recommended that the ND+
module be calibrated once a year
Pulse rate accuracy ± 2 BPM or ± 2%, whichever
is greater
Deflation method Stepwise
General specifications
Model FC2010 and FC2020
Dimensions 7.5" x 6.0" x 10.0"
(19.05 cm x 15.24 cm x 25.4 cm)
Weight 4.4 lb (2 kg)
Operating System embedded Windows 7
Component Minimum specification
Processor > 1.6 GHz
RAM > 1 GB
Hard disk > 16 GB SSD
Analog output channels 4
Analog output
impedance
100 Ω
Output source,
ECG Lead I
1 V ± 0.2 V
Output source,
ECG Lead II
1 V ± 0.2 V
Invasive pressure 10 mV/mmHg
QRS 3 V pulse
Specification
Power consumption < 75 W
Operating range Temperature 0 – 35° C (32 – 95° F)
Storage temperature range -20 – 60° C (-4 – 140° F)
Relative humidity range 15 – 95% non-condensing
Atmospheric
pressure range
500 – 1600 hPa
13
SPO2 module
Specification
Standard EN ISO 9919:2005
Saturation range 0 – 100%
Resolution 1%
Pulse rate 30 – 300 BPM
Resolution 1 BPM
Accuracy 2% or 1 BPM
Arterial accuracy With Philips sensor 70% -100%:
M1196A – 3%
M1131A – 3%
M1132A – 2%
M1133A – 3% neonatal,
2% adult/infant
Body temperature module
Specification
Standard N/A
Measurement range 25 – 45° C
Probe type Philips Reusable Skin
Temperature Probe
Invasive blood pressure
Specification
Standard IEC 60601-2-34
Channels Four (4)
Transducer type 4-wire bridge
Excitation voltage 5 ± 0.1 V
Excitation current limit 20 mA min, 25 mA max
(measured sensor short-circuited)
“No Probe” condition
detection
Supported
Transfer function 25 μV/mmHg
Normal output resistance 300 Ω
Resolution Better than 0.04 mmHg
Measurement range 0 – 300 mmHg
Frequency response Selectable 1.5 Hz, 2.5 Hz, 0-8 Hz,
0-12 Hz, 0-20 Hz, 0-40 Hz, 0-80 Hz
Zero and span adjustment Supported
Cardiac output
Specification
Standard N/A
CO bath channel
Injectate temperature
range and accuracy
0.0 – 27° C ± 0.3° C
Injectate probe
characteristic
2613 Ω @ 25° C
Injectate temperature
resolution
0.1° C
Cardiac output (continued)
Specification
CO bath channel
Injectate temperature
“No Probe” condition
detect
When measured temperature
< -5° C or when probe circuit
is open
Injectate temperature
channel frequency
response
DC to 2 Hz
CO distal
Catheter Edwards thermodilution catheters
System resolution 0.01° C
System accuracy ± 0.05° C
System temperature range 30 – 41° C
ECG
Specification
Standard IEC-60601-2-27
Patient applied risk current
(per IEC 60601-2-27)
10 μA normal condition, 50 μA
single fault condition
Design creepage and
clearances
Minimum 8 mm
Electrical isolation 7.5 kV peak, 6.0 kV rms (1 min.),
no breakdown
ESU withstand 9 kV @ 0.5 – 4.0 MHz no damage
Defibrillator withstand 360 j (x5) with 100 Ω patient load
no damage
Input impedance > 20 MΩ shunted by < 500 pF
Input bias currents < 0.05 μA
Frequency and
impulse response
IEC 60601-2-27
Selectable 0.01 – 100 Hz
(diagnostic mode) or 0.5 – 40 Hz
(monitor mode), -30% points
Notch filters Selectable 50/60 Hz
Baseline reset after
overload IEC 60601-2-27
Restore to usable in 3 seconds
Noise
(per IEC 60601-2-27)
< 30 μV p-p referred to input
Loose patient
lead behavior
Flatline and reported at clinical
software module level
Respirations
Specification
Respiration range 4 – 150 ipm
Accuracy ± 3 ipm
Patient connection RA, LL
Measurement method Transimpedance, 60 kHz
Applied current @ 60 kHz < 200 μA
Open circuit 60 kHz voltage < 5 V p-p
14
Value Default High range Low range Type Silencing
Heart rate 140/40 270 to 35 265 to 30 Visual/tone Configurable
BP systolic 200/0 360 to 10 295 to -40 Visual/tone Configurable
BP diastolic 90/0 360 to 10 295 to -40 Visual/tone Configurable
BP mean 110/0 360 to 10 295 to -40 Visual/tone Configurable
NIBP systolic 200/60 260 to 25 220 to 10 Visual/tone Configurable
NIBP diastolic 160/40 260 to 25 220 to 10 Visual/tone Configurable
Temperature 40/29° 45 to 32° 42 to 29° Visual/tone Configurable
ETCO239/10 100 to 5 95 to 0 Visual/tone Configurable
Respirations 50/10 150 to 9 145 to 4 Visual/tone Configurable
SP02101/90 101 to 85 101 to 65 Visual/tone Configurable
Physiomonitoring alarms and alarm ranges
15
Item Part number
ECG cables and leads
CBL 5+5 ECG trunk cable, AAMI/IEC, 2.7 m M1949A
CBL 5-lead ECG trunk, AAMI/IEC, 2.7 m M1668A
CBL 5-lead set, grabber, chest, AAMI/ICU M1976A
CBL 5-lead set, grabber, AAMI/ICU M1968A
CBL 5-lead set, grabber, chest, IEC/ICU M1978A
CBL 5-lead set, grabber, IEC/ICU M1971A
CBL 3-lead set, grabber, AAMI/ICU M1671A
CBL 3-lead set, grabber, IEC/ICU M1672A
Radiolucent socket leadwires M1649A
Trunk cable covers 989803148861
Combiner for 3-lead sets M1501A
Combiner for 5-lead sets M1502A
Bed sheet clip for trunk cables M1509A
SpO2 cables, sensors, and accessories
CBL SpO2 9-pin D-sub adapter 1.1 m (8-pin) M1943A
Reusable clip, adult SpO2 sensor M1196A
Disposable adult/pediatric SpO2 sensor M1131A
Infant disposable SpO2 sensor M1132A
Neo/infant/adult/disposable SpO2 sensor M1133A
Wristband M1627A
Non-invasive blood pressure supplies
NIBP interconnect cable 3.0 m M1599B
Reusable NIBP Comfort Cuff assortment M1579A
Reusable NIBP Comfort Cuff/infant M1571A
Reusable NIBP Comfort Cuff/pediatric M1572A
Reusable NIBP Comfort Cuff/small adult M1573A
Reusable NIBP Comfort Cuff/adult M1574A
Reusable NIBP Comfort Cuff/large adult M1575A
Reusable NIBP Comfort Cuff/thigh M1576A
Reusable NIBP Comfort Cuff assortment M1577A
Reusable NIBP Comfort Cuff assortment M1578A
Item Part number
Cardiac output supplies
Ice bath temperature probe 23002A
Cardiac output cable, 4.8 m M1643A
Temperature supplies
Skin surface temperature probe 21078A
ETCO2 accessories
Mainstream sensor M2501A
Single-patient use adult airway adapter M2533A
Single-patient use infant airway adapter M2536A
Gas cylinder regulator M2505A
GAS verification gas M2506A
Sidestream CO2 sensor M2741A
CO2 nasal cannula – adult M2744A
CO2 nasal cannula – pediatric M2745A
CO2 nasal cannula – infant M2746A
CO2/O2 nasal cannula – adult M2750A
CO2/O2 nasal cannula – pediatric M2751A
CO2 oral-nasal cannula – adult M2756A
CO2 oral-nasal cannula – pediatric M2757A
CO2/O2 oral-nasal cannula – adult M2760A
CO2/O2 oral-nasal cannula – pediatric M2761A
Airway adapter set – ET > 4.0 mm M2768A
Airway adapter set H – ET > 4.0 mm M2772A
Airway adapter set H – ET ≤ 4.0 mm M2773A
Airway adapter set – ET ≤ 4.0 mm 989803144531
Miscellaneous accessories
Patient cable organizer M2281A
Patient care consumables
© 2017 Koninklijke Philips N.V. All rights reserved.
Specications are subject to change without notice.
www.philips.com
4522 991 23501 * APR 2017

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