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5697480-01 Carescape Canvas Sim v3-3 Eng Intl
5697480-01 Carescape Canvas Sim v3-3 Eng Intl
2nd edition
5697478-01
English
© 2022 General Electric Company
All rights reserved.
2022-11-18
Supplemental Information Manual Contents
Contents
Introduction to this manual ...................................................................................................................... 11
Intended use of this manual ................................................................................................................................................................. 11
Intended markets of this manual..............................................................................................................................................12
Intended audience of this manual .....................................................................................................................................................12
About these devices................................................................................................................................................................................. 12
Safety precautions.................................................................................................................................................................................... 12
Manual conventions ................................................................................................................................................................................. 12
Monitor naming conventions ......................................................................................................................................................12
Acquisition module naming conventions ..............................................................................................................................13
Other naming conventions ..........................................................................................................................................................13
Related documents................................................................................................................................................................................... 14
Ordering manuals...................................................................................................................................................................................... 15
Revision history.......................................................................................................................................................................................... 15
Accessing manuals online ..................................................................................................................................................................... 15
Product availability ................................................................................................................................................................................... 16
Compliance.................................................................................................................................................. 17
Standards compliance............................................................................................................................................................................. 17
IEC 60601-1.................................................................................................................................................................................................. 17
Compliant devices..................................................................................................................................................................................... 17
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Contents Supplemental Information Manual
Alarm specifications................................................................................................................................... 29
About alarms ............................................................................................................................................................................................... 29
Alarm standards compliance ............................................................................................................................................................... 29
Auditory alarm volume, IEC tones......................................................................................................................................................29
Auditory alarm volume, legacy tones ...............................................................................................................................................30
Audio alarm sound tolerances............................................................................................................................................................. 31
Legacy alarm tone sound patterns...........................................................................................................................................31
IEC alarm tone sound patterns ..................................................................................................................................................32
Remote alarm tone sound patterns.........................................................................................................................................32
Auditory information signal characteristics ..................................................................................................................................32
Visual information signals ..................................................................................................................................................................... 33
Alarm delay specifications..................................................................................................................................................................... 33
Time to alarm for tachycardia.....................................................................................................................................................33
Physiological alarm delay specifications................................................................................................................................34
Alarm delay specifications for ECG alarms..................................................................................................................34
Alarm delay specifications for impedance respiration alarms............................................................................36
Alarm delay specifications for SpO2 alarms................................................................................................................36
Alarm delay specifications for rSO2 alarms.................................................................................................................37
Alarm delay specifications for NIBP alarms ................................................................................................................38
Alarm delay specifications for invasive pressures alarms ....................................................................................38
Alarm delay specifications for temperature alarms ................................................................................................42
Alarm delay specifications for cardiac output alarms ............................................................................................43
Alarm delay specifications for SvO2 and ScvO2 alarms .........................................................................................43
Alarm delay specifications for airway gases alarms................................................................................................43
Alarm delay specifications for spirometry and gas exchange alarms..............................................................45
Alarm delay specifications for Entropy alarms ..........................................................................................................46
Alarm delay specifications for NMT alarms.................................................................................................................46
Alarm delay specifications for BIS alarms....................................................................................................................46
Technical alarm delay specifications .......................................................................................................................................46
Remote alarm delay specifications ..........................................................................................................................................57
Alarm priorities and escalation times ..............................................................................................................................................57
Alarm priorities and escalation times for ECG ....................................................................................................................57
Alarm priorities and escalation times for impedance respiration..............................................................................64
Alarm priorities and escalation times for SpO2 ..................................................................................................................65
Alarm priorities and escalation times for rSO2 ...................................................................................................................69
Alarm priorities and escalation times for NIBP...................................................................................................................70
Alarm priorities and escalation times for invasive pressures.......................................................................................72
Alarm priorities and escalation times for temperature ..................................................................................................80
Alarm priorities and escalation times for cardiac output...............................................................................................81
Alarm priorities and escalation times for CCO....................................................................................................................82
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Maintenance.............................................................................................................................................. 261
Before any planned maintenance or regular checks .............................................................................................................. 261
Planned maintenance for the monitor and secondary display .......................................................................................... 261
Planned maintenance for the modules ........................................................................................................................................ 261
Planned maintenance for the frames............................................................................................................................................ 261
Regular checks......................................................................................................................................................................................... 262
Daily checks ..................................................................................................................................................................................... 262
Check every two months ........................................................................................................................................................... 262
Check every six months.............................................................................................................................................................. 262
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Contents Supplemental Information Manual
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Introduction to this manual
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Intended audience of this manual Supplemental Information Manual
Safety precautions
Refer to the user manual for important system safety messages. Safety messages specific to parts of
the system are found in the relevant section. Read all the safety information before using the monitor
for the first time.
Manual conventions
This manual uses the following styles to emphasize text or indicate an action. Also note the terminology
conventions.
Item Description
Courier Indicates hardware keys and connectors.
bold Indicates software terms.
italic Indicates terms for emphasis.
> Indicates menu options to select consecutively.
select The word select means choosing and confirming.
acquisition device A generic term when referring to both the acquisition modules (PDM,
E-modules) and the acquisition platform (CARESCAPE ONE).
NOTE Note statements provide application tips or other useful information.
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Supplemental Information Manual Manual conventions
CARESCAPE Parameter for measuring invasive pressures. Note that in the manual,
the following name is used instead of the graphic: CARESCAPE Pressure.
CARESCAPE Parameter for measuring regional oxygen saturation of blood (rSO2) in
cerebral and somatic tissues with INVOS technology. Note that in the manual, the
following name is used instead of the graphic: CARESCAPE rSO2.
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Related documents Supplemental Information Manual
CARESCAPE Parameter for measuring SpO2 with Nellcor™ sensors with OxiMax™
technology. Note that in the manual, the following name is used instead of the
graphic: CARESCAPE SpO2 — Nellcor.
In this manual, CARESCAPE CO2 is used as a generic term when referring to all of the following products:
CARESCAPE CO2 — LoFlo and CARESCAPE CO2 — Microstream.
In this manual, CARESCAPE SpO2 device is used as a generic term when referring to all of the following
products: CARESCAPE SpO2, CARESCAPE SpO2 — Nellcor, and CARESCAPE SpO2 — Masimo.
In this manual, acquisition platform refers to the CARESCAPE ONE.
In this manual, the following product names are used as generic terms:
• D-lite when referring to D-lite, D-lite+, and D-lite++
• Pedi-lite when referring Pedi-lite and Pedi-lite+
• D-fend Pro when referring to D-fend Pro and D-fend Pro+
• D-lite(+) when referring to D-lite and D-lite+. Does not apply to D-lite++.
Related documents
• CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display User Manual
• CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display Supplies and Accessories
Supplement
• Cleaning and Disinfection Supplement
• Monitor Software Compatibility Supplement for CARESCAPE Software Version 3 (3.3)
• Marquette 12SL ECG Analysis Program Physician’s Guide
• CARESCAPE ONE User Manual
• Instructions for use for CARESCAPE rSO2 — INVOS
• Instructions for use for CARESCAPE CO2 — Microstream
• Instructions for use for B1X5-REC recorder
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Supplemental Information Manual Ordering manuals
Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE representative and
request the part number on the first page of the manual.
Revision history
Revision Description
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Product availability Supplemental Information Manual
Product availability
NOTE
Due to continual product innovation, design and specifications for these products are subject
to change without notice.
Some of the products mentioned in this manual may not be available in all countries. Please consult
your local representative for the availability.
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Compliance
Standards compliance
The system complies with the following standards.
• IEC 60601-1:2020-08
• IEC 60601-1-2:2020-09
• IEC 60601-1-6:2020-07
• IEC 62366-1:2020-06
Compliance to parameter and function specific standards is disclosed in the applicable sections.
Compliance applies only to those products that are currently being manufactured and shipped. It does
not apply to older devices or devices that have had their software upgraded.
IEC 60601-1
• Type of protection against electrical shock: Class I.
• Degree of protection against electrical shock: applied parts are marked with a symbol indicating
degree of protection.
• Degree of safety of application in the presence of flammable anesthetic mixture with air or with
oxygen or nitrous oxide: Not suitable.
WARNING
EXPLOSION. Do not use this equipment in the presence of flammable anesthetics, vapors
or liquids.
• Degree of protection against harmful ingress of water: IPX1 (minimum), see individual device
specifications.
• Mode of operation: Continuous.
• Method(s) of sterilization or disinfection recommended by the manufacturer: see the supplemental
information provided.
Compliant devices
The devices listed in the following table have been verified to be compliant with the standard 60601-1:2020, 3.2 edition:
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F2 Frame specifications
Size (H × W × D) 160 × 284 × 165 mm (6.3 × 11.2 × 6.5 in)
Weight < 2.4 kg (5.29 lb)
Operating temperature range 10 to 40°C (50 to 104°F)
Non-operating temperature range -20 to 60°C (-4 to 140°F)
Operating humidity range 10 to 90% RH non-condensing
Non-operating humidity range 10 to 90% RH non-condensing
Operating altitude range 700 to 1060 hPa (525 to 795 mmHg)
Non-operating altitude range 500 to 1060 hPa (375 to 795 mmHg)
Degree of protection against solid ob- IP21
jects and water
Power requirements line voltage 100-240 VAC ±10%, 50/60 Hz
Power consumption 100VA maximum
Service life 7 years
F5 Frame specifications
Size without modules and cables (H x W 162 x 290 x 225 mm (6.4 x 11.4 x 8.9 in)
x D)
Weight without modules 3 kg (6.6 lb)
Operating temperature range 10 to 40°C (50 to 104°F)
Non-operating temperature range 0 to 50°C (32 to 122°F)
Operating humidity range 10 to 90% RH non-condensing
Non-operating humidity range 10 to 90% RH non-condensing
Power requirements 16.7 V @ 4.6 A supplied by the monitor through an ePort interface cable
Operating voltage range 14.5 to 18.0 V
E-module interface voltage 15 V ±0.75
Power consumption Idle (no modules): < 3 W
Maximum module load: 57 W average (1 h), 77 W maximum
Degree of protection against harmful in- IPX1
gress of water
Default synchronization connector Analog output for ECG, invasive blood pressure and defibrillation synchroni-
zation output
Not supported with CARESCAPE Software Version 3.
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Supplemental Information Manual Design, environmental, and physical specifications
F7 Frame specifications
Size without modules and cables (H x W 138 x 314 x 215 mm (5.4 x 12.4 x 8.5 in)
x D)
Weight without modules 3 kg (6.6 lb)
Operating temperature range 10 to 40°C (50 to 104°F)
Non-operating temperature range 0 to 50°C (32 to 122°F)
Operating humidity range 10 to 90% RH non-condensing
Non-operating humidity range 10 to 90% RH non-condensing
Power requirements 16.7 V @ 3.9 A supplied by the monitor through an ePort interface cable
Operating voltage range 11.2 to 18.0 V
E-module interface voltage 15 V ±0.75
Power consumption Idle (no modules): < 3 W
Maximum module load: 39 W average (1 h), 65 W maximum
Default synchronization connector Analog output for ECG, invasive blood pressure and defibrillation synchroni-
zation output
Not supported with CARESCAPE Software Version 3.
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Alarm specifications
About alarms
Some alarms and alarm settings are only available with certain products and licenses in use. Refer to
the Licensed software options section for a list of available licenses. For information on the feature
availability with the Canvas 1000 and the Canvas Smart, see the user manual.
Canvas 1000
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 26 dB(A)
Medium priority alarm: 26 dB(A)
Low priority alarm: 26 dB(A)
6 High priority alarm: 51 dB(A)
Medium priority alarm: 48 dB(A)
Low priority alarm: 46 dB(A)
10 High priority alarm: 75 dB(A)
Medium priority alarm: 72 dB(A)
Low priority alarm: 70 dB(A)
Canvas Smart
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 26 dB(A)
Medium priority alarm: 26 dB(A)
Low priority alarm: 26 dB(A)
6 High priority alarm: 51 dB(A)
Medium priority alarm: 48 dB(A)
Low priority alarm: 46 dB(A)
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Canvas Smart
Alarm volume setting Maximum sound pressure level
10 High priority alarm: 75 dB(A)
Medium priority alarm: 72 dB(A)
Low priority alarm: 70 dB(A)
D19 display
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 27 dB(A)
Medium priority alarm: 26 dB(A)
Low priority alarm: 25 dB(A)
6 High priority alarm: 58 dB(A)
Medium priority alarm: 56 dB(A)
Low priority alarm: 55 dB(A)
10 High priority alarm: 81 dB(A)
Medium priority alarm: 79 dB(A)
Low priority alarm: 78 dB(A)
Canvas 1000
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 25 dB(A)
Medium priority alarm: 26 dB(A)
Low priority alarm: 26 dB(A)
6 High priority alarm: 50 dB(A)
Medium priority alarm: 43 dB(A)
Low priority alarm: 41 dB(A)
10 High priority alarm: 72 dB(A)
Medium priority alarm: 66 dB(A)
Low priority alarm: 64 dB(A)
Canvas Smart
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 25 dB(A)
Medium priority alarm: 26 dB(A)
Low priority alarm: 26 dB(A)
6 High priority alarm: 50 dB(A)
Medium priority alarm: 43 dB(A)
Low priority alarm: 41 dB(A)
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Canvas Smart
Alarm volume setting Maximum sound pressure level
10 High priority alarm: 72 dB(A)
Medium priority alarm: 66 dB(A)
Low priority alarm: 64 dB(A)
D19 display
Alarm volume setting Maximum sound pressure level
1 High priority alarm: 29 dB(A)
Medium priority alarm: 22 dB(A)
Low priority alarm: 21 dB(A)
6 High priority alarm: 58 dB(A)
Medium priority alarm: 49 dB(A)
Low priority alarm: 45 dB(A)
10 High priority alarm: 80 dB(A)
Medium priority alarm: 71 dB(A)
Low priority alarm: 67 dB(A)
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Auditory information signal characteristics Supplemental Information Manual
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Alarm delay specifications Supplemental Information Manual
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UAC 4 disconnect
P1 to P4 pressure malfunction Invasive pres- <5s
sures
BIS measurement removed BIS <5s
BIS sensor check failed BIS 120 s
BIS sensor expired BIS <5s
Calibration fail Temperature PDM, CS ONE: < 5 s
Call service NIBP 22 s (average) (22 to 23 s range)
Change telemetry battery ECG Telemetry: < 5 s
Check CO2 adapter Airway gases 41 s (average) (41 to 42 s range)
Check EEG referential montage EEG 13 s
Check gas flow Airway gases CS ONE: 42 s (average) (41 to 42 s range)
E-musb: 41 s (average) (41 to 42 s range)
Check NIBP NIBP PDM: 114 s (average) (83 to 122 s range)
CS ONE: 110 s (average) (109 to 111 s range)
Check sample gas out Airway gases CARESCAPE respiratory modules: 43 s (average) (41 to 44 s
range)
E-miniC: 43 s (average)
Check sample line Airway gases 57 s (average) (56 to 58 s range)
Check SpHb SpO2 <5s
Check SpO2 probe / SpO2 < 30 s
Check SpO2(2) probe
Check Water Trap Airway gases CARESCAPE respiratory modules: 54 s (average) (52 to 56 s
range)
E-miniC: 52 s (average) (52 to 53 s range)
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Parameter specifications
Parameter specifications
WARNING
INACCURATE RESULTS. Do not use or store the equipment outside the specified temperature,
humidity, or altitude ranges, or outside the specified performance range. Using or storing the
equipment outside the specified operating environment or outside the specified performance
range may cause inaccurate results.
About parameters
Some parameters are only available with certain products and licenses in use. Refer to the Licensed
software options section for a list of available licenses. For information on the feature availability with
the Canvas 1000 and the Canvas Smart, see the user manual.
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Heart rate accuracy and response to irregu- PDM: Heart rate calculation operates with irregular rhythms of IEC
lar rhythm 60601-2-27 Clause 201.7.9.2.9.101 b) 4), according to Figure 201.101,
as follows:
Ventricular bigeminy: 80 bpm
Slow alternating ventricular bigeminy: 59 bpm
Rapid alternating ventricular bigeminy: 126 bpm
Bidirectional systoles: 110 bpm
ECG heart rate averaging computation Average of 12 second median values
ECG heart rate display update interval < 2 seconds
ECG QRS detection range ±0.5 to ±5 mV
ECG QRS detection width (Q to S) 40 to 120 ms
PVC rate range 0 to 300 PVCs per minute
PVC rate resolution 1 PVC per minute
ST numeric range -20.0 to +20.0 mm
ST numeric resolution 0.1 mm
ST numeric accuracy Per EC57 (ESC database):
• ST Mean Absolute Difference < 100 µV
• ST Mean Difference (Mean error) < 50 µV
• Correlation coefficient > 0.90
• ST tolerance ± 0.4 mm or 20%, whichever is greater
QRS numeric accuracy Per EC57 (AHA and MIT-BIH databases):
• QRS sensitivity >97.5%
• QRS positive predictivity: >97.5%
VEB numeric accuracy Per EC57 (AHA and MIT-BIH databases):
• VEB sensitivity >90%
• VEB positive predictivity: >90%
VF numeric accuracy Per EC57 (AHA and MIT-BIH databases):
• VF episode sensitivity >95%
• VF episode positive predictivity: >95%
QT numeric range 100 to 900 ms
QT numeric accuracy ±30 ms in the range 250 ms to 750 ms, HR < 120/min, unspecified
outside this range
QT numeric resolution 1 ms
QTc numeric range 100 to 900 ms
QTc numeric resolution 1 ms
ECG gain selections 0.5x = 5 mm/mV
1x = 10 mm/mV
2x = 20 mm/mV
4x = 40 mm/mV
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Impedance respiration measurement range 2 to 200 breaths per minute or 3 to 200 breaths per minute (depending
on the apnea alarm delay selection)
Impedance respiration measurement accu- • 2 to 120 breaths per minute: ±1 breath per minute
racy • 121 to 200 breaths per minute: ±3 breaths per minute
Impedance respiration input impedance PDM:
range • Dynamic: 0.2 to 10 Ω
• Static: 100 to 1500 Ω @ 52.7 kHz
CS ONE:
• Dynamic: 0.4 to 10 Ω
• Static: 100 to 1500 Ω @ 52.3 kHz
Impedance respiration waveform sweep 0.625, 6.25 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s
speed options
Impedance respiration normalized respira- PDM: 140 µA AC RMS typical
tion sensing current CS ONE: <100 µA RMS
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recommended, the specified accuracy range is increased by ± 1 digit, as compared to adult usage, to
account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.
For more detailed information, refer to the supplemental analysis graphs in the appendix (Bland and
Altman. Agreement between methods of measurement with multiple observations per individual.
Journal of Biopharmaceutical Statistics (2007) vol. 17 pp. 571-582).
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synthetic signals from a patient simulator that comprised representative cardiac and signal artifact
components. Applicability: OxiMax MAXA, MAXAL, MAXP, MAXI, and MAXN sensors.
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PDM (Masimo):
• Without motion:
• SpO2 (70 to 100%): ±2 Adult, ±3 Neonate
• SpO2 (< 70%): Unspecified
• With motion:
• SpO2 (70 to 100%): ±3 Adult, ±3 Neonate
• SpO2 (< 70%): Unspecified
• Low perfusion:
• SpO2 (70 to 100%): ±2 Adult, ±3 Neonate
• SpO2 (< 70%): Unspecified
Pulse oximetry saturation measurement val- The specified accuracy for each module is the root-mean-square (RMS)
ue accuracy (E-modules) difference between the measured values and the reference values. Be-
cause pulse oximetry equipment measurements are statistically distrib-
uted, only about two-thirds of the pulse oximetry equipment measure-
ments can be expected to fall within the ±1 Arms of the value measured
by a CO-oximeter. Actual accuracy depends on sensor. Please refer to
the sensor instructions for use for more detailed information.
E-MASIMO:
• Without motion and low perfusion:
• SpO2 (70 to 100%): ±2a Adult, ±3 Neonate
• SpO2 (< 70%): Unspecified
• With motion:
• SpO2 (70 to 100%): ±3 Adult, ±3 Neonate
• SpO2 (< 70%): Unspecified
E-NSATX:
• SpO2 (70 to 100%): ±2b, c Adult, ±3d Neonate
• SpO2 (<70%): Unspecified
a M-/LNCS: E1 ± 2.5%, M-/LNCS TC-1: ±3.5%
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Pulse oximetry peripheral pulse rate accura- The specified accuracy for each module is the root-mean-square (RMS)
cy difference between the measured values and the reference values. Ac-
tual accuracy depends on sensor. Please refer to the sensor instructions
for use for more detailed information.
PDM (Masimo), E-MASIMO:
• Without motion: ±3 bpm Adult, ±3 bpm Neonate
• With motion: ±5 bpm Adult, ±5 bpm Neonate
• Low perfusion: ±3 bpm Adult, ±3 bpm Neonate
PDM (Nellcor):
• ±3 bpm Adult, ±3 bpm Neonate
• Low perfusion: ±3 bpm Adult, ±3 bpm Neonate
E-NSATX:
• Normal perfusion: ±3 bpm (20 to 250 bpm)
• Low perfusion: ±3 bpm (20 to 250 bpm)
• Unspecified (251 to 300 bpm)
Pulse oximetry peripheral pulse rate display 1 bpm
resolution
Pulse oximetry perfusion range PDM (Masimo) and E-MASIMO: 0.02 to 20%
PDM (Nellcor) and E-NSATX: 0.03 to 20%
Perfusion index measurement range (Masi- 0.02 to 20%
mo rainbow SET only)
Pleth variability index measurement range 0 to 100%
(Masimo rainbow SET only)
Pulse oximetry data update period < 30 s
Pulse oximetry saturation and pulse rate The PDM (Masimo) and E-MASIMO measurement modules provide aver-
averaging time aging time options of 2, 4, 8, 10, 12, 14, and 16 seconds. When using
the default averaging time the overall alarm generation delay of SpO2
is typically less than 28 seconds from the actual SpO2 value in the
patient. This delay is due to the SpO2 averaging, signal processing and
data transmission delays. The delay consists of the alarm condition and
alarm generation delay, being typically <10 seconds and <18 seconds,
respectively. For pulse rate the alarm generation delay is typically less
than 11 seconds, in which the alarm signal delay is less than a second.
The SpO2 and Pulse Rate data is updated every second.
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The Nellcor OXIMAX algorithm used in the PDM (Nellcor) and E-NSATX
measurement modules automatically extends the amount of data re-
quired for measuring SpO2 and pulse rate depending on the measure-
ment conditions. There are various matrices within the saturation pulse
rate detection algorithm. Some of these are used to assess the severity
of conditions presented to the measuring of SpO2 and pulse rate on
a patient. These individual matrices or combinations of these matrices
are used to determine the quality of the received SpO2 signal. The
advanced signal processing in the algorithms automatically extends the
amount of data required for measuring SpO2 and pulse rate depending
on the measuring conditions. During normal measurement conditions,
the averaging time is approximately three seconds. The overall alarm
generation delay of SpO2 is typically less than 28 seconds from the
actual SpO2 value in the patient. This delay is due to the SpO2 averaging,
signal processing and data transmission delays. The delay consists of
the alarm condition and alarm generation delay, being typically <10 sec-
onds and <18 seconds, respectively. For pulse rate the alarm generation
delay is typically less than 11 seconds, in which the alarm signal delay
is less than a second. The SpO2 and Pulse Rate data is updated every
second.
Pulse oximetry sweep speed options 6.25, 12.5, 25, and 50 mm/s
Signal strength indication Signal strength is indicated through the display of asterisks (No asterisk,
*, **, or ***). All waveforms are normalized to fit the allocated display
area.
Pulse oximetry waveform size options 1x, 2x, 4x, and 8x
Wavelength of SpO2 probe LEDs Information on the peak wavelengths and maximum output power can
be especially useful to clinicians performing photodynamic therapy.
PDM (Masimo), E-MASIMO:
• Infrared LED: 880 to 905 nm
• Red: 653 to 660 nm
PDM (Nellcor), E-NSATX:
• Infrared LED: 900 nm
• Red: 660 nm
Maximum energy of SpO2 probe LEDs Information on the peak wavelengths and maximum output power can
be especially useful to clinicians performing photodynamic therapy.
E-NSATX: < 15 mW
E-MASIMO: < 15 mW (@ 50 mA pulse)
PDM (Masimo) and PDM (Nellcor): < 15 mW
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SPI calculations
Adaptive histogram transformation (scale of 0 to 100) from the pulse interval and plethysmogram’s
pulse amplitude (PGA) =
100 - 0.3 * Pulse interval (with normalization) - 0.7 * PGA (with normalization) = SPI
The SPI algorithm is published: Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P,
Paloheimo M, Rantanen M, Takala P, Viertiö-Oja H, Yli-Hankala A. Assessment of surgical stress during
general anaesthesia. (Br J Anaesth 2007; 98: 447-55).
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When used with a compatible module, the system complies with IEC 80601-2-30:2018-03.
The measurement has been validated with patient populations requiring clinical investigations
according to ISO 81060-2:2013 apart from pregnant and pre-eclamptic women.
Compatible modules and specified accessories: applied parts are classified as TYPE BF DEFIBRILLATION-
PROOF per IEC 60601-1 Clause 6.2.
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Invasive pressure physiological range -25 to 320 mmHg (-3.3 to 42.7 kPa)
Pressure measurement range -30 to 320 mmHg (-4 to 42.7kPa)
Invasive pressure measurement accuracy ±4% or ±4 mmHg (±0.5 kPa), whichever is greater
Invasive pressure pulse rate range PDM: 30 to 300 bpm
E-modules: 30 to 250 bpm
CS ONE: 0 to 360 bpm
Invasive pressure pulse rate accuracy PDM, CS ONE: ±2% or ±2 bpm, whichever is greater
E-modules: ±5% or ±5 bpm, whichever is greater
Invasive pressure pulse rate display resolu- 1 bpm
tion
Invasive pressure zero adjustment range ±150 mmHg (±20.0 kPa)
Invasive pressure frequency response PDM: User-selectable as DC to 12 Hz or 40 Hz (-3dB)
(waveform filter) E-modules: Upper limit user-selectable as DC to 4 Hz, 5 Hz, 6 Hz, 7 Hz, 8
Hz, 9 Hz, 11 Hz, 14 Hz, 17 Hz, or 22 Hz (-3dB)
CS ONE: 0 to 12 Hz or 0 to 40 Hz (-3dB), user-selectable
Invasive pressure waveform display scale se- 0-10 to 0-300 mmHg, with a step size of 10 mmHg (0.0-2.0, to 0.0-40.0
lections kPa, with a step size of 2.0 kPa); or automatic scale based on valid
waveform values from last 4 seconds with a lower limit of -100 mmHg
(-14 kPa) and an upper limit of 350 mmHg (48 kPa) and a step size of 10
mmHg (2.0 kPa)
Invasive pressure waveform display range -30 to 300 mmHg (-4.0 to 40.0 kPa)
Invasive pressure sweep speed options 6.25, 12.5, 25, and 50 mm/s
Invasive pressure transducer sensitivity 5 µV/V/mmHg
Invasive pressure analog output signal (gain) PDM: 1 V/100 mmHg ±10%
CS ONE: 1 V/100 mmHg ±3% or 2 mmHg, whichever is greater (excludes
transducer)
Invasive pressure analog output delay PDM, CS ONE: < 35 ms
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Right ventricular ejection frac- E-COP and E-COPSv modules: Ejection fraction is determined using an exponential
tion measurement method technique by synchronizing sensed R-waves with points of temperature changes on
the time temperature (thermodilution curve). Once ejection fraction, cardiac output
and heart rate are known, right ventricular volumes may be calculated.
Right ventricular ejection frac- E-COP and E-COPSv modules: 1 to 85%
tion measurement range
Right ventricular ejection frac- E-COP and E-COPSv modules: ±2 % as measured by electronically generated pulsatile
tion measurement repeatability curves for range 10 to 60%
Right ventricular ejection frac- E-COP and E-COPSv modules: 1%
tion measurement resolution
Cardiac output (C.O.) C.O. is the amount of blood ejected by the heart to the peripheral circulation
every minute. Continuous Cardiac Output uses the pulse contour method, and it
is calibrated by using the thermodilution technique.
Continuous cardiac output calculation also uses the CVP value, which is obtained
automatically or can be set manually. If the algorithm does not get the CVP value
automatically or manually, a default value of 5 mmHg is used.
Continuous cardiac output (CCO)
Measurement range: 0.25 l/min to 25 l/min (Pulse contour cardiac output)
Measurement accuracy: CoV ≤2%
Transpulmonary cardiac output
Measurement range: 0.25 l/min to 25 l/min (Pulse contour cardiac output)
Measurement accuracy: CoV ≤2%
Stroke volume (SV)
Measurement range: 1 ml to 250 ml
Measurement accuracy: CoV ≤2%
Cardiac index (C.I.)
Measurement range: 0.10 l/min/m2 to 15.0 l/min/m2
Continuous cardiac output index
(CCI)
Measurement range: 0.1 l/min/m2 to 15.0 l/min/m2 (pulse contour cardiac output index)
Stroke volume index (SVI)
Measurement range: 1 ml/m2 to 125 ml/m2
Global end-diastolic volume (GEDV)
Measurement range: 40 ml to 4800 ml
Measurement accuracy: CoV ≤3%
Global end-diastolic volume index
(GEDI)
Measurement range: 80 ml/m2 to 2400 ml/m2
Intrathoracic blood volume (ITBV)
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For indexing volumetric parameters, the DuBois method is used for BSA calculation in patients whose
body weight ≥ 15 kg:
BSA = weight0.425 * height0.725 * 0.007184
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PBSA PBSA is calculated using the BSA formula where body weight is replaced by
PBW.
NOTE
The ScvO2 measurement is only available with E-COPSv-01 modules.
Compatible modules and specified accessories: applied parts are classified as a DEFIBRILLATION PROOF TYPE CF per
IEC 60601–1 Clause 6.
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• E-sCO, E-sCOV, E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal conditions
after a 20 minute warm-up period: 18 to 28ºC, within ±5ºC of calibration
• Ambient pressure:
• E-miniC:
normal conditions after a 30 minute warm-up period: 660 to 1060 mbar, within ±67 mbar of
calibration
• E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal
conditions after a 20 minute warm-up period: 660 mbar to 1060 mbar, ±67 mbar of calibration
• Ambient humidity:
• E-miniC: normal conditions after a 30 minute warm-up period: 20 to 80% RH, within ±20% RH
of calibration
• E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal
conditions after a 20 minute warm-up period: 20 to 80% RH, non-condensing, within ±20% RH
of calibration
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N2O measurement display resolution E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: 1%
NOTE
Modules that do not measure anesthetic agent do not dis-
play N2O, but use it internally in the module for compensa-
tion.
Gas cross effects to N2O by anesthetic E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: < 2 vol%
agents
N2O rise time E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
• ≤ 320 ms with 2 and 3 m sampling line lengths
• ≤ 360 ms with 6 m sampling line length
N2O drift per 6 hours of operation E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: < 0.3 vol%
Anesthetic agents total system response E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
time • < 3.5 s (< 3.8 s for Halothane) with 2 and 3 m sampling line lengths
• < 5.4 s (< 6.5 s for Halothane) with 6 m sampling line length
Anesthetic agents measurement range E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
• Hal, Enf, Iso: 0 to 6 vol%
• Sev: 0 to 8 vol%
• Des: 0 to 20 vol%
Anesthetic agents measurement accuracy E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
±(0.15 vol% + 5% of reading)
Anesthetic agents display resolution E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
• Resolution is 0.01% when the AA concentration is below 1.0 vol%
• Resolution is 0.1% when the AA concentration is 1.0 vol% or greater
• AA concentration over the specified measurement range but within
the display range: 1%
• In the presence of agent mixture, values between 0 and 9%: 0.1%
• In the presence of agent mixture, values ≥ 10%: 1%
Gas cross effects to anesthetic agents by E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: < 0.15 vol%
N2O
Anesthetic agents rise time E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE:
• ≤ 420 ms (< 800 ms for Halothane) with 2 and 3 m sampling line
lengths
• ≤700 ms (< 1800 ms for Halothane) with 6 m sampling line length
Hal, Enf, Iso, and Sev drift per 6 hours of E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: < 0.1 vol%
operation
Des drift per 6 hours of operation E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: < 0.3 vol%
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Effects of non-interfering gases and vapors • A gas is considered non-interfering if its effects to the measured gas
are as follows:
• CO2: < 0.2 vol%
• O2, N2O: < 2 vol%
• Anesthetic agents: < 0.15 vol%
• The following gases are non-interfering when tested according to
ISO 80601–2–55: Freon (R134a) (for CO2, O2, and N2O), ethanol, ace-
tone, isopropanol, methane, nitrogen, water vapor, and with CARE-
SCAPE respiratory modules also carbon monoxide and nitric oxide.
CARESCAPE respiratory modules:
• The effects caused by N2O to the measurement of CO2, O2 and
anesthetic agents are automatically compensated for.
• The effects caused by anesthetic agents to the measurement of CO2
and N2O are automatically compensated for.
Barometric pressure compensation The system automatically compensates for changes in barometric pres-
sure over the atmospheric pressure range of 660 to 1060 mbar (66 to
106 kPa).
N2O compensation E-miniC: Configured from 0 to 40% or from 40 to 80%
CARESCAPE respiratory modules: The system automatically compen-
sates for N2O
O2 compensation E-miniC: Configured from 21 to 40% or 40 to 100%
CARESCAPE respiratory modules: The system automatically compen-
sates for O2.
Warm-up time E-miniC: 1 min for operation, 30 min for full specifications
E-sCO, E-sCOV, and E-sCOVX: 1 min for operation with CO2 and O2, 20
min for full specifications
E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: 1 min for
operation with CO2, O2, and N2O, 5 min for operation of anesthetic
agents, and 20 min for full specifications
Flow rate (diverting sampling) E-miniC: 150 ml/min ± 25 ml/min
CARESCAPE respiratory modules: 120 ml/min ± 20 ml/min
The electronic sampling rate of the gas sensor signals is 25 Hz, equaling a new data point on the gas waveform traces
every 40 ms.
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E-miniC is not suitable for use with patients weighing less than 5 kg (11 lbs).
Accuracy specifications apply in normal conditions:
• Ambient temperature:
• E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal conditions after a 10 minute
warm-up period: 10 to 40ºC
• Ambient pressure:
• E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal conditions after a 10 minute
warm-up period: 660 mbar to 1060 mbar
• Ambient humidity:
• E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal conditions after a 10 minute
warm-up period): 10 to 98% RH, non-condensing
• Airway humidity:
• E-sCOV, E-sCOVX, E-sCAiOV, E-sCAiOVX, and E-sCAiOVE: normal conditions after a 10 minute
warm-up period): 10 to 100% RH
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Spirometry calculations
Spirometry airway pressures calculations
PEEP, Ppeak, Pmean and Pplat are measured by a pressure transducer on a measurement board.
Atmospheric pressure is used as a reference measurement. The pressure measurement takes place
between the patient circuit and the intubation tube.
Static pressure measurement maneuvers are automatically identified based on an increased zero flow
period at the end of inspiration or expiration. Static compliance is calculated if static PEEP and static
Pplat measurement were made within a two-minute period.
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Entropy calculations
Entropy measurement is based on acquisition and processing of raw EEG and FEMG signals by using the
Entropy algorithm, a GE application of Spectral Entropy.
The algorithm is published: Viertiö-Oja H, Maja V, Särkelä M, Talja P, Tenkanen N, Tolvanen-Laakso H,
Paloheimo M, Vakkuri A, Yli-Hankala A, Meriläinen P. Description of the Entropy algorithm as applied in
the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue
2:154-161, 2004).
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NMT measurement intervals • TOF/DBS modes with OR or PACU software package: Manual, 10 s, 12
s, 15 s, 20 s, 1 min, 5 min, and 15 min
• TOF/DBS modes with ICU or ED software package: Manual, 20 s, 1
min, 5 min, 15 min, 30 min, 60 min, and 120 min
• ST mode: Manual, 1 s, 10 s, and 20 s
NMT measurement stimulus pulse A square wave with constant current
NMT measurement pulse width 100, 200, or 300 µs
NMT measurement tetanic stimulation dura- 5 s
tion
NMT measurement stimulus current range • Supramax: 1 to 70 mA
• Manual: 1 to 70 mA, in 1 mA steps
• Regional block: 0 to 5 mA, in 0.1 mA steps
NMT measurement stimulus current accura- ±20% or ±3 mA, whichever is greater, within the current range 1-70 mA
cy over the impedance range
NMT measurement range of load impedance Range of load 0.5 to 3 kOhm, max load 3 kOhm
and maximum load (The impedance over this range does not have an effect on the stimulus
parameters.)
NMT measurement maximum voltage 300 V peak
Regional block stimulation mode Single twitch
Regional block mode stimulation intervals 1, 2, or 3 s
Regional block mode stimulus pulse A square wave with constant current
Regional block mode pulse width 40 µs
Regional block mode stimulus current range 0 to 5.0 mA peak with 0.1 mA steps
Regional block mode stimulus current accu- 20% or ±0.3 mA, whichever is greater
racy
Regional block mode range of load 0.5 to 3 kOhm
Regional block mode maximum voltage 300 V peak
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Compatible module and specified accessories: EEG measurement applied parts are classified as a
DEFIBRILLATION PROOF TYPE BF per IEC 60601-1 Clause 6.2.
BIS calculations
The BIS is computed in real time using three steps:
1. The raw EEG signal is broken down second by second, and the segments that have artifact are
identified and removed.
2. The BIS is calculated by combining EEG features associated with anesthetic effect.
3. The index is modified to reflect the amount of suppressed EEG signal in the raw waveform.
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Calculation specifications
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Input parameter Range Formula (for calculated or estimated values; measured val-
ues do not have formulas)
ATMP display range 300 to 1200 mmHg (1
mmHg steps) or 40 to 160
kPa (0.1 kPa steps) or 400
to 1600 mbar (1 mbar
steps)
CaO2 display range 10 to 400 ml/l (1 ml/l steps) Calculated:
or 1 to 40 ml/dl (1 ml/dl CaO2 (ml/l) = (1.34 * Hb (g/l) * SaO2 (%)/100) + (PaO2 (mmHg) *
steps) 0.031)
Estimated:
CaO2 (ml/l) = (1.34 * Hb (g/l) * SaO2 (%))/100
CvO2 display range 10 to 400 ml/l (1 ml/l steps) Calculated:
or 1 to 40 ml/dl (1 ml/dl CvO2 (ml/l) = (1.34 * Hb (g/l) * SvO2 (%)/100) + (PvO2 (mmHg) *
steps) 0.031)
Estimated:
CvO2 (ml/l) = (1.34 * Hb (g/l) * SvO2 (%))/100
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Default settings
Software packages
The monitor can have up to five software packages, but only one can be enabled at a time. Software
packages pre-configure the monitor’s behavior and appearance for a specific clinical environment. There
are five software packages:
• ED: Emergency Department (also called Emergency Care)
• ICU: Intensive Care Unit (also called Critical Care)
• OR: Operating Room (also called Anesthesia Care)
• PACU: Post Anesthesia Care Unit (also called Post Anesthesia Care)
• NICU: Neonatal Intensive Care Unit (also called Neonatal Care)
ICU is the factory default software package. Software packages cannot be customized, but the profile
and care unit settings for a software package can be customized.
Software features
The monitor is factory-enabled with basic software features (e.g., 24 hour trending, guarded alarm
limits). For more information on these features, refer to the user manual or contact your local GE
representative.
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Software profiles
Each software package supports up to eight active profiles. A profile is a group of unique settings
suited to a particular care unit or patient demographic within the broader software package clinical
environment (e.g., alarm limits, screen layouts, trends and snapshot settings). Profile settings can be
customized. The following table lists the factory default profiles for each software package. The default
profile is listed first.
ED ICU NICU OR PACU
Medical Medical Premature General General
Trauma Surgical Cardiac Perfusion Invasive
Cardiac Cardiac Full-term Invasive Regional
Neuro Neuro Infant Regional Neuro
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Software settings
NOTE
The software in use (enabled software profile and licenses), the monitor type, and the
acquisition modules used with the monitor determine which configurable settings are
available on the monitor. Some settings may not appear on all configurations. Refer to the
Licensed software options section for a list of available licenses. For information on feature
availability with Canvas 1000 and the Canvas Smart, refer to the user manual.
If the monitor resets while monitoring a patient, care should be taken to confirm the settings are
appropriate for the current patient, making changes where necessary.
If the supply mains to the equipment is interrupted while the monitor is on, the monitor shuts down
immediately. When restarted within 15 minutes, it will continue monitoring with the previously selected
user settings.
DEMO MODE
Entering the DEMO MODE is password protected. The DEMO MODE can only be activated (confirmed) if
there is no active patient case.
When you exit the DEMO MODE, the monitor restarts with the same settings that were used in the
actual monitoring mode before entering the DEMO MODE. In other words, any changes made to the
settings in the DEMO MODE do not affect the actual monitoring mode.
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NOTE
The DEMO MODE is not meant for actual patient monitoring, it is for demonstration
purposes only.
Profile settings
Profile settings are password protected. Profile settings are established during installation/configuration
of the monitor and can be downloaded to other monitors. Instructions to access the profile settings are
provided in this document. The profile setting factory default values are also provided.
Profile settings only apply to a specific profile. Profile settings have three values:
• Current values: Values displayed on the monitor for the current patient.
• Saved values: Values selected and saved during configuration/installation of the monitor to meet
the needs of a particular clinical environment.
• Factory default values: Permanent values used in case of failure that allow the software application
recover from failure by reverting to these values for system operation.
Profile settings generally share the same reset behavior. There are three types of reset:
• Case reset/discharge: Case is reset/patient is discharged from the monitor. Generally, the saved
value is retained and used after the reset.
• Cold start: Start-up of the software application after the monitor is shut down for 15 minutes or
more. Generally, the saved value is retained and used after the reset.
• Warm start: Start-up of the software application after the monitor is shut down for less than 15
minutes. Generally, the current value is retained and used after the reset.
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5. Change the settings as needed in Alarms, Parameter Alarms, Screens, Admit/Discharge, Units,
Parameters, Drug List, Standby Sites, Show in Screen Setup, Roving, Telemetry, and Printer.
All changes are automatically saved and applied.
• To revert to the factory default care unit settings, select Factory Default > Yes.
Alarm settings
Select Care Unit Settings > Alarms to define the alarm settings for the care unit. The following table lists the factory
default settings.
Local Alarms
Setting Description ED ICU NICU OR PACU
Show Alarm Limits Enable the current Enabled
alarm limits to dis-
play in parameter
window.
Latching Alarms Select the level of High None
alarm priority to
sound until the event
is acknowledged.
Alarm Tones Select the audible IEC
alarm tone sounds.
Low Priority Alarm Selects the audible Single
Tone alarm tone sound for
low priority alarms.
Alarm Volume Con- Select whether the Common for All
trol alarm volume adjusts
all priority alarms
(Common for All)
or a separate vol-
ume for low priority
alarms (Separate for
Low).
Minimum Alarm Select the minimum 6
Volume for: High & audible alarm volume
Medium Priority for high and medium
priority alarms.
Minimum Alarm Select the minimum 6
Volume for: Low audible alarm vol-
Priority ume for low priority
alarms.
Audio Pause Time Select the number of 2
(min) minutes to pause au-
dible alarms.
All Audio Pause (5 Select to allow all Disabled
min) audio alarms to be
paused for 5 mi-
nutes.
Reminder Volume Select the audible re- 5
minder volume.
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Local Alarms
Setting Description ED ICU NICU OR PACU
Audio Alarm Enable audible Disabled
alarms to be turned
off (Off Allowed).
Alarm Light Enable the alarm Disabled Enabled Disabled
light to be turned off
(0% (Off) Allowed).
Pause Monitor Enable the monitor Disabled
display to turn off
and pause audible
alarms at the moni-
tor (Allowed).
Pause Monitor & Enable the monitor Disabled
Central display to turn off
and pause audible
alarms at the mon-
itor and central (Al-
lowed).
Remote Alarms
Setting Description ED ICU NICU OR PACU
Allow Audio Pause: Enable Audio pause No
For Remote Bed for a remote bed
from this monitor.
Allow Audio Pause: Select which remote Not Allowed
From Remote Loca- devices on the net-
tion work can pause
alarms for this moni-
tor.
Allow Remote Select the alarm pri- Low Alarms
Pausing of ority levels that can
be remotely paused.
Show Remote Pa- Enable the patient’s Disabled
tient Name name to display
when using the AVOA
feature.
Remote Alarm Enable the alarm On
Light light for remote
events.
Remote Alarm Tone Select the audible Local
alarm tone for re-
mote alarms.
Remote Bed Selec- Select to restore the Enabled
tions: Restore after list of selected re-
Discharge mote beds after a
discharge.
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Screen settings
Select Care Unit Settings > Screens to define the screen settings for the care unit. The following table lists the factory
default settings.
Admit/discharge settings
Select Care Unit Settings > Admit/Discharge or Start / Reset Case to define the discharge settings for the care unit.
The following table lists the factory default settings.
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Parameter settings
Select Care Unit Settings > Parameters to define the parameter settings for the care unit. The following table lists
the factory default settings.
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Select Care Unit Settings > Parameters > 12 Lead ECG > Reasons for 12 Lead open a window to define the reasons
for 12 lead for the care unit. The following reasons are available: Therapy Outcome Control, Chest Discomfort,
Angina Pectoris, Pre-Op Evaluation, Post-Op Evaluation, Post MI, Dizziness, Routine Test. Along with the
Default Reasons, up to 17 additional Configurable Reasons can be defined.
ECG settings
Select Care Unit Settings > Parameters > ECG to define the ECG parameter settings for the care unit. The following
table lists the factory default settings.
Catheter settings
Select Care Unit Settings > Parameters > Catheters to define the catheters for the care unit. Up to 50
additional catheters can be defined.
The following default catheters are available for the E-COP and E-COPSv:
• Edwards: 777HF8, 741HF75, 139HF75, 131HF7, 931HF75, 132F5, D431HF7
The following default catheters are available for the PDM:
• Edwards: 5.0F, 6.0F, 7.0F, 7.5F, 8.0F
• BD: 5.0F, 7.0F, 7.5F
• Arrow: 4.0F, 5.0F, 6.0F, 7.0F, 7.5F
• Hospira: 5.0F, 7.0F, 7.5F, 8.0F
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ED, ICU, OR and PACU software package drug list default settings
Select Care Unit Settings > Drug List > Edit/View to define the care unit Drug List. The following table lists the
14 commonly used drugs factory default settings. The Starting Dose and Dose Increment define the values in the
Titration table.
NOTE
The Solution Volume default unit of measure is ml.
The Drug Amount default unit of measure is mg for all drugs except Heparin and Insulin, which are I.U.
The Dose default unit of measure is defined by the Dose Unit for the specific drug.
Drug Name Solution Drug Concentration Dose Unit Dose Starting Dose Incre-
Volume Amount Unit Dose ment
Aminophylline 500 500 mg/ml mg/kg/h 0.50 0.1 0.1
Amrinone 500 500 mg/ml mcg/kg/min 7.5 0.5 0.5
Bretylium 500 2000 mg/ml mg/kg/min 5.0 0.1 0.1
Dobutamine 250 250 mg/ml mcg/kg/min 2.0 0.5 0.5
Dopamine 250 400 mg/ml mcg/kg/min 2.0 1.0 1.0
Epinephrine 250 1.0 mcg/ml mcg/kg/min 0.02 0.01 0.01
Heparin 250 25000 I.U./ml I.U./kg/h 10 1.0 1.0
Insulin 100 100 I.U./ml I.U./kg/h 0.10 0.01 0.01
Isoproterenol 250 50 mg/ml mcg/kg/min 0.05 0.01 0.01
Lidocaine 500 100 mg/ml mcg/kg/min 10.0 0.5 0.5
Nitroglycerin 250 50 mcg/ml mcg/kg/min 0.50 0.1 0.1
Nitroprusside 250 50 mcg/ml mcg/kg/min 0.50 0.1 0.1
Norepinephrine 500 8.0 mcg/ml mcg/kg/min 0.10 0.01 0.01
Procainamide 500 2000 mg/ml mcg/kg/min 20 1.0 1.0
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Drug Name Solution Drug Concentration Dose Unit Dose Starting Dose Incre-
Volume Amount Unit Dose ment
Dobutamine 50 50 mg/ml mcg/kg/min 5.0 0.5 0.5
Dopamine 50 50 mg/ml mcg/kg/min 2.0 1.0 1.0
Epinephrine 50 0.5 mg/ml mcg/kg/min 0.02 0.01 0.01
Heparin 50 30 I.U./ml I.U./h 0.6 1.0 1.0
Insulin 50 5 I.U./ml I.U./kg/h 0.01 0.01 0.01
Isoproterenol 50 0.5 mg/ml mcg/kg/min 0.05 0.01 0.01
Norepinephrine 50 0.8 mcg/ml mcg/kg/min 0.08 0.01 0.01
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Roving settings
Select Care Unit Settings > Roving to define the roving settings for the care unit. The following table lists the factory
default settings.
Telemetry settings
Select Care Unit Settings > Telemetry to define the telemetry (combination monitoring) settings for the care unit.
The following table lists the factory default settings.
Print settings
Select Care Unit Settings > Printer to define the printer settings for the care unit. The following table lists the factory
default settings.
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Select Arterial tab to adjust the invasive pressures arterial alarms profile settings. The following table lists the factory
default settings.
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Select Venous tab to adjust the invasive pressures venous alarm profile settings. The following table lists the factory
default settings.
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Select PA, ICP & P1-P8 tab to adjust the invasive pressures alarm profile settings. The following table lists the factory
default settings.
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Select Ventricular & Atrial tab to adjust the invasive pressures ventricular and atrial alarm profile settings. The
following table lists the factory default settings.
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Page settings
Pages define monitor screen formats, including which parameter windows display in the upper (vertical)
and lower (horizontal) parameter window areas, as well as split screen settings and combined invasive
pressure waveform settings.
Each software package has a pre-defined primary Normal Screen page. The following software
packages also have additional pre-defined pages:
• ED software package Neuro profile: EEG.
• ICU software package (all profiles except Pediatric and Infant): EEG.
• ICU software package Pediatric and Infant profiles: NEO-VENT.
• NICU software package: NEO-VENT.
• OR software package Invasive profile: VENTILAT., SWAN-GANZ, and AoA.
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Snapshot settings
Select Profile Settings > Trends & Snapshot > Snapshot to define the snapshot settings for the profile. The following
table lists the factory default settings.
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5. Change the settings as needed for Day, Month, Year, Hour, Min, and Time Format.
6. Select Confirm.
Select the ECG tab to adjust the ECG alarm priority settings for the current patient. For more information, refer to the
user information provided. The following table lists the factory default settings.
Select the Invasive Pressures tab to adjust the invasive pressure alarm priority settings for the current patient. For
more information, refer to the user information provided. The following table lists the factory default settings.
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Select the Other Parameters tab to adjust other parameter alarm priority settings for the current patient. For more
information, refer to the user information provided. The following table lists the factory default settings.
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Setting NICU
UAC 1 Red
UVC 2 White
Art 3 Red
CVP 4 Cyan
P5 to P7 White
P8 Red
Select Monitor Setup > Main Setup > Colors > Specific to adjust the color settings for the current patient. The
following table lists the factory default settings.
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Report settings
Select Monitor Setup > Main Setup > Printing > Reports > Trends to adjust the report settings for the current
patient. For more information, refer to the user manual. The following table lists the factory default settings.
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Device settings
Select Monitor Setup > Main Setup > Printing > Devices > Setup to adjust the printing device settings for the
current patient. The options vary based on the print devices that are configured and available in the care unit or
network. For more information, refer to the user manual. The following table lists the factory default settings.
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Calculation settings
Select Data & Pages > Calculations > Hemo, Oxy or Vent to adjust the calculation settings for the
current patient. For more information, refer to the user manual.
Select Data & Pages > Other Patients > View Patients to view a list of all patient beds in the selected Unit or all
remote beds configured for alarm notifications. For more information, refer to the user manual. The following table lists
the factory default settings.
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Select Data & Pages > Admit/Discharge or Start / Reset Case > Patient > Edit All Demographics to adjust the
patient demographic settings for the current patient. For more information, refer to the user manual. Some settings
remain blank (empty) until a value is selected for the current patient. The following table lists the factory default
settings.
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Trend settings
Select Trends to adjust the trends view settings for the current patient. For more information, refer to the user manual.
The following table lists the factory default settings.
Select Trends > View > Graphic to adjust the graphic trends view settings for the current patient. For more informa-
tion, refer to the user manual. The following table lists the factory default settings.
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Select Trends > View > Numeric to adjust the numeric trends view settings for the current patient. For more
information, refer to the user manual. The following table lists the factory default settings.
Select Trends > View > Event to adjust the event view settings for the current patient. For more information, refer to
the user manual. The following table lists the factory default settings.
Select Trends > View > Snapshot to adjust the snapshot time scale for the current patient. For more information,
refer to the user manual. The following table lists the factory default settings.
Select Trends > View > Snapshot > Snapshot Setup to adjust the snapshot view settings for the current patient. For
more information, refer to the user manual. The following table lists the factory default settings.
Select Trends > View > Histogram to adjust the time scale for the current patient. For more information, refer to the
user manual. The following table lists the factory default settings.
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Select Trends > View > Histogram > Histogram Setup > SpO2 to adjust the histogram settings for the current
patient. For more information, refer to the user manual. The following table lists the factory default settings.
Select Trends > View > Histogram > Histogram Setup > HR to adjust the histogram settings for the current patient.
For more information, refer to the user manual. The following table lists the factory default settings.
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Select Trends > Graphic > Trend Scales > IP/NIBP to adjust these settings for the current patient. The following table
lists the factory default settings.
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Select Trends > Graphic > Trend Scales > Cardiac Output to adjust these settings for the current patient. The
following table lists the factory default settings.
Select Trends > Graphic > Trend Scales > Temp to adjust these settings for the current patient. The following table
lists the factory default settings.
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NOTE
High and low alarm limit values are fixed and no algorithms are used, and auto limits are off
by default.
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Select Monitor Setup > Main Setup > Parameter Setup > ECG > ECG tab > Setup > 12 Lead Analysis to adjust
these settings for the current patient. The following table lists the factory default settings.
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ECG tab > Setup > 12 Lead Analysis > Settings to
adjust these settings for the current patient. The following table lists the factory default settings.
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Select Monitor Setup > Parameter Setup > ECG > ECG tab > Setup > 12 Lead Analysis > Filter to adjust this
setting for the current patient. The following table lists the factory default setting.
NOTE
This setting is only available when a 12SL report is open for viewing.
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Select Monitor Setup > Main Setup > Parameter Setup > ECG > ECG tab > HR/PR Alarms to adjust these settings
for the current patient when the HR Alarms care unit setting is Multiple. The following table lists the factory default
settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ECG tab > PVC/SVC Alarms to adjust these
settings for the current patient when the HR Alarms care unit setting is Multiple. The following table lists the factory
default settings.
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Supplemental Information Manual Parameter default settings
ST default settings
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ST tab > Setup to adjust these settings for the
current patient. The following table lists the factory default settings.
5- and 6-lead
modes: V
LEAD A
ST Lead 3 Select the ST lead 5-, 6-, 10-lead and 12RL modes: aVL
3 lead to display 3-lead mode: NONE,CASC
for 3-, 5-, 6-, and
10-lead and 12RL
modes.
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ST tab > Realtime View to adjust the Time Scale
setting for the current patient. The factory default setting is 1h.
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ST tab > ST > Trend View to adjust these settings
for the current patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > ECG > ST tab > Trend View > Ischemic Burden to adjust
these settings for the current patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
QT default settings
QT setup default settings
Select Monitor Setup > Main Setup > Parameter Setup > ECG > QT tab > Setup to adjust these settings for the
current patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Impedance Respiration > Alarms to adjust these
settings for the current patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > SpO2(2) > Setup to adjust these settings for the current
patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > SpO2 > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > SpO2(2) > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > SpO2 > SpHb > Alarms to adjust these settings for the
current patient. The following table lists the factory default settings.
Select Monitor Setup > Main Setup > Parameter Setup > rSO2 > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Setting Description OR
Color Select the color for displayed numerics, trends and messages Violet
Select Monitor Setup > Main Setup > Parameter Setup > NIBP > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art1 > Advanced to adjust the
following factory default settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art1 > Art Alarms to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art1 > PR(Art 1) Alarms to adjust
the heart rate alarm default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > UAC1 > Advanced to adjust the
following factory default settings for the current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > UAC1 > UAC Alarms to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > UAC1 > PR(UAC) Alarms to adjust
the pulse rate alarm default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > CVP 2 > Advanced to adjust the
Filter Hz factory default setting for the current patient. The default setting is 12.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > CVP 2 > CVP Alarms to adjust the
following factory default settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > UVC2 > Advanced to adjust the
Filter Hz factory default setting for the current patient. The default setting is 12.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > UVC2 > UVC Alarms to adjust the
following factory default settings for the current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Fem 3 > Advanced to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Fem 3 > Fem Alarms to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Fem 3 > PR(Fem) Alarms to adjust
the ECG alarm default settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art 3 > Advanced to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art 3 > Art Alarms to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art 3 > PR(Art) Alarms to adjust
the ECG alarm default settings for the current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > PA 4 > Advanced to adjust the
Filter Hz factory default setting for the current patient. The default setting is 12.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > PA 4 > PA Alarms to adjust the
following factory default settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > CVP 4 > Advanced to adjust the
Filter Hz factory default setting for the current patient. The default setting is 12.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > CVP 4 > CVP Alarms to adjust the
following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > P5, P6, or P7 > Advanced to adjust
the following factory default settings for the current patient.
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > P5, P6, or P7 >P5 Alarms , P6
Alarms, or P7 Alarms to adjust the following factory default settings for the current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art 8 > Advanced to adjust the
following factory default settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Invasive Pressures > Art 8 > Art 8 Alarms to adjust the
following factory default settings for the current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Temperatures > T1, T2 > Alarms to adjust these settings
for the current patient. The following table lists the factory default settings.
Select Monitor Setup > Main Setup > Parameter Setup > Temperatures > T3, T4 > Alarms to adjust these settings
for the current patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Temperatures > Tblood > Alarms to adjust these
settings for the current patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Cardiac Output > View > Configure to adjust these
settings for the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Cardiac Output > View to adjust these settings for the
current patient.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > SvO2/ScvO2 > Alarms to adjust these settings for the
current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Gases > CO2 > Alarms to adjust these settings for the
current patient. The following table lists the factory default settings.
O2 default settings
Select Monitor Setup > Main Setup > Parameter Setup > Gases > O2 > Setup to adjust these settings for the
current patient. The following table lists the factory default settings.
Select Monitor Setup > Main Setup > Parameter Setup > Gases > O2 > Alarms to adjust these settings for the
current patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Gases > Agent/N2O > Alarms to adjust these settings for
the current patient.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Spirometry/Gas Exchange > Paw Alarms to adjust these
settings for the current patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > Spirometry/Gas Exchange > MV/Vent Alarms to adjust
these settings for the current patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > Entropy > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > NMT > Regional Block to adjust these settings for the
current patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > EEG > View to adjust these settings for the current
patient. The following table lists the factory default settings.
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Supplemental Information Manual Parameter default settings
Select Monitor Setup > Main Setup > Parameter Setup > EEG > AEP > Setup to adjust these settings for the current
patient. The following table lists the factory default settings.
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Parameter default settings Supplemental Information Manual
Select Monitor Setup > Main Setup > Parameter Setup > BIS > Alarms to adjust these settings for the current
patient. The following table lists the factory default settings.
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Maintenance
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Regular checks Supplemental Information Manual
Regular checks
Daily checks
• Check that the accessories, cables, cable connectors, monitor, modules, and display parts are clean
and intact.
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Supplies and accessories
Ordering information
Contact your local GE representative to order supplies or accessories. Accessories without a GE part
number must be ordered from the OEM manufacturer, and vice versa.
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SpO₂ supplemental analysis graphs
1. SpO2 — SaO2
2. Average SaO2 and SpO2
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Additional accuracy information for Masimo sensors Supplemental Information Manual
For other Masimo sensors, refer to sensor-specific instructions for use provided by the sensor
manufacturer.
Adtx/Pdtx
Inf/Neo/NeoPt
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Supplemental Information Manual Additional accuracy information for Masimo sensors
DBI
DCI/DCIP
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Additional accuracy information for Masimo sensors Supplemental Information Manual
TFI
TCI
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Supplemental Information Manual Additional accuracy information for Masimo sensors
YI
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Electromagnetic compatibility
IEC 60601-1-2
The system complies with IEC 60601–1–2:2020–09.
Compliance with the standard IEC 60601–1–2:2020–09 applies only to those products that are currently
being manufactured and shipped. For standards compliance information, refer to the supplemental
information provided with the device.
According to parameter-specific IEC 60601-2-xx and IEC 80601-2-xx series standard requirements
for ESU (electrosurgical unit) tests, the equipment is protected against malfunction caused by
electrosurgery.
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Essential performance in EMC Supplemental Information Manual
ECG
ECG heart rate accuracy ±1% or ±1 bpm, whichever is greater
ST numeric accuracy ST Mean Difference (Mean error) < 50 µV
Impedance respiration
Impedance respiration rate accuracy ±1 breath per minute (0 to 120 breaths per minute)
NIBP
NIBP measurement range accuracy (over the display Static: ±2 mmHg (0.3 kPa)
range)
SpO2 essential performance when signal strength is indicated as normal (***) and no messages about ques-
tionable signal quality are displayed
Pulse oximetry saturation measurement value accu- PDM: SpO2 (70 to 100%): ±2 to ±3.5
racy E-NSATX modules: SpO2 (70 to 100%): ±2 to ±4
E-MASIMO modules: SpO2 (70 to 100%): ±2 to ±3.5
The accuracy depends on the sensor type.
Pulse oximetry peripheral pulse rate accuracy PDM:±3 bpm
E-NSATX modules:±3 bpm
E-MASIMO modules:±3 bpm
Total hemoglobin
SpHb measurement accuracy ±1 g/dL
Temperature
Temperature measurement accuracy PDM: (0°C to 45°C ): ±0.2°C for reusable sensors and ±0.3 °C for
disposable sensors
E-PT: (10°C to 45°C): ±0.2°C for reusable sensors and ±0.3 °C for
disposable sensors
Tblood
Tblood measurement accuracy PDM: (30ºC to 42ºC): ±0.2ºC
E-COPSv: (34ºC to 42ºC): ±0.3ºC
E-PICCO: (34ºC to 42ºC): ±0.3ºC
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Supplemental Information Manual EEG accessories and electromagnetic compatibility
SvO2
Invasive pressures
Invasive pressure measurement accuracy ±4% or ±4 mmHg (±0.5 kPa)
CO2
CO2 measurement accuracy ±(0.2 vol% + 2% of reading) with 5% nominal CO2 reference gas
O2
O2 measurement accuracy ±(1 vol% + 2% of reading) with 55% nominal O2 reference gas
N2O
N2O measurement accuracy ±(2 vol% + 2% of reading) with 33% nominal N2O reference gas
AA (Desflurane)
Anesthetic agents measurement accuracy Des: ±(0.15 vol% + 5% of reading) with 2% nominal desflurane
reference gas
Entropy
Total noise level <6 µV peak-to-peak
BIS
Total noise level < 6 uV peak-to-peak
EEG
Total noise level < 6 uV peak-to-peak
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BIS accessories and electromagnetic compatibility Supplemental Information Manual
electromagnetic disturbance to the EEG measurement, it is recommended that you select the EEG curve
to be shown on the screen.
If there is a disturbance on the EEG curve and/or values, increase the distance between EEG accessories
and the RF field.
Electromagnetic emissions
Guidance and manufacturer’s declaration — electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user
of the device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The monitor uses RF energy only for its internal function. Therefore, RF
CISPR 11 emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class A The equipment is suitable for use in all establishments other than
CISPR 11 domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctua- Complies
tions/flicker emissions
IEC 61000-3-3
NOTE
The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR
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Supplemental Information Manual Electromagnetic immunity
11 class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
Electromagnetic immunity
Guidance and manufacturer’s declaration — electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below. It is the responsibility of
the hospital to assure that the device is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment —
guidance
Electrostatic Discharge ± 8 kV contact ± 8 kV contact Floors should be wood, concrete or
(ESD) ± 2 kV, ± 4 kV, ± 8 kV, ± 2 kV, ± 4 kV, ± 8 kV, ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
± 15 kV air ± 15 kV air humidity should be at least 30%.
Electrical Fast Transient/ ± 2 kV for power supply ± 2 kV for power supply Mains power quality should be that
Burst lines lines of a typical commercial or hospital
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for input/output environment.
lines lines
Surge IEC 61000-4-5 ± 0.5 kV, ± 1 kV differen- ± 0.5 kV, ± 1 kV differen-
tial mode tial mode
± 0.5 kV, ± 1 kV, ± 2 kV ± 0.5 kV, ± 1 kV, ± 2 kV
common mode common mode
Voltage dips Ut = 0%, 0.5 cycle (0, 45, Ut = 0%, 0.5 cycle (0, 45,
Mains power quality should be that
IEC 61000-4-11 90, 135, 180, 225, 270, 90, 135, 180, 225, 270,of a typical commercial or hospital
and 315 degrees) and 315 degrees) environment. If the user of the equip-
Ut = 0%, 1 cycle Ut = 0%, 1 cycle ment requires continued operation
during power mains interruptions, it
Ut = 70%, 25/30 cycles (0 Ut = 70%, 25/30 cycles (0 is recommended that the equipment
degrees) degrees) be powered from an uninterruptible
power supply or a battery.
Short interruptions and Ut = 0%, 250/300 cycles Ut = 0%, 250/300 cycles Mains power quality should be that
voltage variations on of a typical commercial or hospital
power supply input lines environment. If the user of the equip-
IEC 61000-4-11 ment requires continued operation
during power mains interruptions, it
is recommended that the equipment
be powered from an uninterruptible
power supply or a battery.
Power Frequency Mag- 30 A/m 30 A/m Power frequency magnetic fields
netic Field 50 Hz or 60 Hz 10 A/m EEG when AEP is should be at levels characteristic of a
IEC 61000-4-8 active typical location in a typical commer-
cial or hospital environment.
50 Hz and 60 Hz
Immunity to proximity 134.2 kHz 134.2 kHz Proximity magnetic fields should be
magnetic fields 65 A/m 65 A/m at levels characteristic of a typical
IEC 61000-4-39 location in a typical commercial or
13.56 MHz 13.56 MHz hospital environment.
7.5 A/m 7.5 A/m
1.5 A/m for SvO2 meas-
urement
NOTE Ut is the AC mains voltage prior to application of the test level.
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Electromagnetic immunity for RF Supplemental Information Manual
NOTE At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection
from structures, objects, and people.
a The EEG measurement is inherently very sensitive as it measures very small physiologic signals.
b The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553
MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
c For more information, see section Proximity field immunity compliance.
d The BIS measurement based on measuring the EEG signal is inherently very sensitive.
e Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level
above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the equipment.
f Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
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Supplemental Information Manual Recommended separation distances
2 The EEG measurement is inherently very sensitive as it measures very small physiologic signals.
For transmitters rated at a maximum output power not listed above, the recommended separation distance [d] in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE
These guidelines may not apply in all instances. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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Proximity field immunity compliance Supplemental Information Manual
Guidance and manufacturer’s declaration — electromagnetic immunity (IEC/EN 60601-1-2, 4.1 Edition)
Test fre- Band Service Modulation Maximum Dis- Immunity Immunity
quency (MHz) power (W) tance compliance test level
(MHz) (m) level (V/m) (V/m)
810 800 to GSM 800/900, Pulse Modulation 2 0.3 28 28
960 TETRA 800, iDEN 18 Hz
870
820, CDMA 850,
930 LTE Band 5
1720 1700 to GSM 1800; Pulse Modulation 2 0.3 28 28
1990 CDMA 1900; 217 Hz
1845
GSM 1900;
1970 DECT; LTE Band
1, 3, 4, 25; UMTS
2450 2400 to Bluetooth, Pulse Modulation 2 0.3 28 28
2570 WLAN, 802.11 217 Hz
b/g/n, RFID
2450, LTE Band
7
5240 5100 to WLAN 802.11 Pulse Modulation 0.2 0.3 9 9
5800 a/n 217 Hz
5500
5785
NOTE Separation distance (d) has been calculated using the formula (IEC 60601–1–2:2020) E = 6*√P/d, where E
is the immunity test level (V/m) of the monitoring system, P is the maximum power (W) of the transmitter.
NOTE The distance values represent the recommended separation distance between interfering equipment and
the monitor, modules, and accessories.
NOTE The performance of the BIS measurement may degrade with the RF fields shown in this table.
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