Vigilance II
VGSV or CEDV Monitor
Continuous Cardiac Output (CCO), Mixed Venous Oxygen
Saturation (SvO2) and Continuous End Diastolic Volume (CEDV)
CCOmbo V Catheter
CCOmbo V VIP Catheter
Model: 774F75, 774HF75
Length: 110 cm
Size: 7.5F
Recommended Introducer Size: 8.5F – 9.0F
Model: 777F8, 777HF8
Length: 110 cm
Size: 8F
Recommended Introducer Size: 9.0F
PA Distal Port
Balloon Inflation Volume
• Transduce distal lumen – proper
waveform is PA
• Appropriate inflation volume
is 1.5 cc
VIP Port 777F8, 777HF8
• 30 cm from tip
• Located in RA/SVC
Thermistor
Proximal Injectate Port
• 4 cm from tip
In main body of PA
• 26 cm from tip
• Located in RA or SVC
• If incorrectly positioned in introducer
sheath, Bolus CO measurement will
be erroneously high due to reflux of
injectate within introducer
• Transduce Proximal Injectate Lumen –
proper waveform is RA or SVC
Thermal Filament
• 14 – 25 cm from tip
• Rests between RA and RV
• Should be free floating and avoid
endocardial surface
• Erroneous CCO measurements may
result if beyond pulmonic valve
Note: Assess patient physiology. Atypical physiology
and heart size may require special handling.
Computation Constants required for Bolus Cardiac Output only
For use with bath temperature probes
CATHETER MODELS
INJECTATE TEMP
0 – 5º C
19 – 22º C
23 – 25º C
774F75, 774HF75
777F8, 777HF8
INJECTATE VOLUME (ML)
COMPUTATION CONSTANT (CC)
10
5
10
5
10
5
0.564
0.257
0.582
0.277
0.594
0.283
0.550
0.256
0.585
0.282
0.600
0.292
0.574
0.287
0.595
0.298
0.559
0.263
0.602
0.295
Computation Constants for CO-Set+ Delivery System
6 – 12º C
8 – 16º C
18 – 25º C
10
5
10
5
• Patient’s
respiratory patternIImay
have
•or
Allow
more time Monitor
for the monitor to measure and
Troubleshooting
for Vigilance
VGSV
CEDV
changed
display EDV
“Alert CEDV: Signal Adapting –
Continuing" message
• Use of some types of Sequential
Compression
Devices (SCDs)
POSSIBLE
CAUSE
• Turn SCD cooling system off temporarily
SUGGESTED ACTION
displayslave
EDVcable connections between Vigilance
• Verify
• Turn
SCD
cooling
system
off temporarily
monitor
and
bedside
monitor
SUGGESTED
ACTION
Vigilance Monitor Heart Rate (HR)
does not match bedside monitor
No CEDV value with Heart Rate (HR)
slaved and CCO displayed
CEDV not trending on graph
Vigilance Monitor Heart Rate (HR)
does
not match
bedside
monitor
No
CEDV
value with
Heart
Rate (HR)
slaved and CCO displayed
c
hange(HR
d < 40 bpm or HR > 170 bpm
range
• Use
of some
types
of Sequential
[or 150
bpm
for
software
ver. 6.0])
POSSIBLE
CAUSE
• Compression
No Heart rate Devices
detected(SCDs)
Loose slave
cable connection
• Patient’s
respiratory
pattern may have
• Average
changed patient’s heart rate is out-ofrange
< 40
bpm
HR > rate
170 bpm
Patient’s
time-averaged
heart
• Use
of(HR
some
types
ofor
Sequential
[or
150 bpm
for
software
ver.less
6.0])
is greater
than
150
bpm
but
Compression
Devices
(SCDs)
• than
No Heart
rate to
detected
or equal
170 bpm
Loose slave
cableheart
connection
• Average
patient’s
rate is out-of• Physiologic
patient’s
status
range (HR <change
40 bpminor
HR > 170
bpm
Patient’s
time-averaged
heart
rate
• Unsecured
leads
/ connections
of
[or
150 bpm
for software
ver. 6.0])
ishegreater
than
ECG Srate
ignadetected
l150 bpm but less
• tNo
Heart
than
equalcable
todue
170
• Double
sensing
tobpm
atrial or
Looseorslave
connection
atrial-ventricular (AV) pacing
• Physiologic
change in patient’s
status
Patient’s time-averaged
heart rate
• Unsecured
leads
/ connections
is greater than
150
bpm but lessof
tthan
he Eor
CGequal
Signatol 170 bpm
• Double sensing due to atrial or
atrial-ventricular
(AV)inpacing
• Physiologic
change
patient’s status
• Unsecured
Non-CEDV leads
catheter
being used of
/ connections
• tIncorrect
ECG
he ECG S
ignalslave cable
• Double sensing due to atrial or
• atrial-ventricular
Heart rate is averaged
when
(AV) pacing
CCO is on
• Non-CEDV catheter being used
• Incorrect ECG slave cable
• CEDV graph not enabled
• Heart rate is averaged when
CO is on catheter being used
• C
Non-CEDV
• Incorrect ECG slave cable
CEDV
notEDVI,
trending
on
EF,
EDV,
ESVHeart
andgraph
ESVI
Vigilance
Monitor
Rate on
(HR)
Patient
Data
screen
are blank
does
not
match
bedside
monitor
when CALC is pressed
CEDV rate
graph
not
Manual
heart
rateenabled
data when
entry overrides
• Heart
is averaged
auto
(denoted by asterisk
C
CO calculation
is on
next to HR on Patient Data screen)
CEDV not trending on graph
EF, EDV, EDVI, ESV and ESVI on
Patient Data screen are blank
when CALC is pressed
• CEDV graph not enabled
• Manual heart rate data entry overrides
auto calculation (denoted by asterisk
next to HR on Patient Data screen)
EF, EDV, EDVI, ESV and ESVI on
Patient Data screen are blank
when CALC is pressed
• Manual heart rate data entry overrides
auto calculation (denoted by asterisk
next to HR on Patient Data screen)
Enablemanual
CEDV
onoff
graph:
heart
rate
Temporarily
turn
CCO,data:
wait a minimum of
• Clear
- 0Press
TREND
1
secoEDIT
nds and verify HR correlates with
- Press
SELECT
GRAPH Heart Rate data
CURSOR
to asterisked
bedside
monitor
Graph 1, 2 or 3 to turn on EDV
- Press CLEAR
- Press CEDV
CALC on graph:
• Enable
• -Clear
manual
heart rate data:
Press
TREND
EDIT
- Press SELECT
GRAPH
CURSOR
to asterisked
Rate
data
- Press
Graph
1, 2 or 3 toHeart
turn on
EDV
- Press CLEAR
- Press
CALCheart rate data:
• Clear
manual
- Press EDIT
- CURSOR to asterisked Heart Rate data
- Press CLEAR
- Press CALC
PROBLEM OR DISPLAYED MESSAGE
Troubleshooting
for Vigilance
IImay
VGSV
or
CEDV
Monitor
SignalRate
Adapting
–
Patient’s patient’s
respiratory
pattern
have
Allowuntil
more
time for
the rate
monitor
to measure
average
heart
is within
range and
Heart
Signal
• Average
heart
rate is
out-of• Wait
“Alert CEDV:
Continuing"
message
Loss”
message
PROBLEM OR DISPLAYED MESSAGE
“Alert CEDV: Signal Adapting –
“Alert
CEDV:message
Heart Rate Signal
Continuing"
Loss”
message
“Alert CEDV:
Exceeding HR
Threshold Limit” message
(software ver. ≥ 6.2)
“Alert CEDV: Heart Rate Signal
“Alert CEDV:
Irregular ECG Pattern”
Loss”
message
“Alert CEDV:
Exceeding
message
(Software
ver. ≥HR
6.2)
Threshold Limit” message
(software ver. ≥ 6.2)
“Alert CEDV: Exceeding
Irregular ECG
HR Pattern”
message
ver. ≥ 6.2)
Threshold(Software
Limit” message
(software ver. ≥ 6.2)
“Alert CEDV: Irregular ECG Pattern”
No
CEDV (Software
value withver.
Heart
Rate (HR)
message
≥ 6.2)
slaved and CCO displayed
• Allow more time for the monitor to measure and
Wait
heart rate is within range
•d
isplauntil
y EDaverage
V
slave
cable
between Vigilance
average
HRconnections
values off temporarily
• Verify
Turn SCD
cooling
system
monitorstandard
and bedside
monitor
• Follow
hospital
protocol for reducing
patient’s HR below 150 bpm
• Wait until average heart rate is within range
Followslave
standard
protocol
• Verify
cablehospital
connections
between Vigilance
Verify average
HR or
values
• Re-position
reconnect
monitor
andleads
bedside
monitor ECG slave cable
• iFollow
hospital protocol for reducing
f necesstandard
sary
patient’s HRreference
below 150
bpm
• Re-position
lead
to minimize atrial
spike sensing.
Followaverage
standard
protocol
• Select
appropriate
lead configuration
to maximize
Verify
HRhospital
values
• HR
Re-position
leadsminimize
or reconnect
ECG
cable
triggers
and
atrial spike
sensing
Follow
standard
hospital
protocol
for slave
reducing
f necessappropriateness
aHR
ry below 150 bpm
• iAssess
of milliamperage (mA)
patient’s
• Re-position
pacing levelsreference lead to minimize atrial
• spike
Followsensing.
standard hospital protocol
• Select
appropriate
configuration
toused
maximize
Verify Edwards
CEDV
catheter
isECG
being
Re-position
leads
orlead
reconnect
slave
cable
minimize
atrial is
spike
sensing
• iHR
Verify
ECG
slave cable
being
used
f netriggers
cecorrect
ssary and
Assess appropriateness
of to
milliamperage
(mA)
• Re-position
reference lead
minimize atrial
Temporarily
levelsturn off CCO, wait a minimum of
• pacing
spike
sensing.
10 seco
nds and velead
rify Hconfiguration
R correlates w
• Select
appropriate
toithmaximize
monitor
• bedside
Verify
Edwards
catheter
being
used
HR
triggers
andCEDV
minimize
atrial is
spike
sensing
Verify correct
ECG slave of
cable
is being used
• Assess
appropriateness
milliamperage
(mA)
• pacing
Enable levels
CEDV on graph:
turn off CCO, wait a minimum of
Press TREND
• -Temporarily
0Press
secEdwards
oSELECT
nds andCEDV
verifycatheter
HR correislabeing
tes witused
h
GRAPH
• -1
Verify
monitor
Presscorrect
Graph
1, 2 slave
or 3 to
turn isonbeing
EDV used
• -bedside
Verify
ECG
cable
For professional use. CAUTION: Federal (United States) law restricts this
device to sale by or on the order of a physician. See instructions for use
for full prescribing information, including indications, contraindications,
warnings, precautions, and adverse events.
Edwards Lifesciences devices placed on the European market meeting the essential
requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the
CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, CCOmbo, CCOmbo V, CO-Set, CO-Set+,
Vigilance, Vigilance ll, and VIP are trademarks of Edwards Lifesciences Corporation.
© 2013 Edwards Lifesciences Corporation.
All rights reserved. AR10455
Edwards Lifesciences | edwards.com
Irvine, California 92614 USA