smartcare_ps_instructions_for_use_supplement_for_ev.pdf
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Instructions for Use
SmartCare/PS
Knowledge-based system
for automating clinical
guidelines
Software 1.1
WARNING
For a full understanding of the
performance characteristics of this
medical device, the user should
carefully read these Instructions for
Use before use of the medical device.
Supplement to the Instructions for Use
for Evita XL from Software version 6.n
Page 2
Trademarks
–
Evita®
–
–
Evita XL®
AutoFlow®
–
SmartCare®
are trademarks owned by Dräger.
Definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important information about a potentially hazardous situation
which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to
the medical device or other property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Abbreviations and Symbols
Please refer to "Abbreviations and Terms"
on page 9 and "Symbols" on page 10 for explanations.
2
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Contents
Contents
New Features of SmartCare SW 1.1 . . . . . . .
4
For Your Safety and that of Your Patients . .
5
Application . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . .
Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Recommended Settings for Alarm Limits . . . . .
7
7
8
Abbreviations and Terms. . . . . . . . . . . . . . . .
9
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Before First-time Use . . . . . . . . . . . . . . . . . . . . 11
Switching on Evita XL. . . . . . . . . . . . . . . . . . . . 11
Additional Explanations . . . . . . . . . . . . . . . .
29
Upper and Lower Limits of the Main
Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnosis – Classification of Patient
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35
Web-based Application Service (WAS) . . . .
36
Preparing WAS . . . . . . . . . . . . . . . . . . . . . . . .
Starting WAS . . . . . . . . . . . . . . . . . . . . . . . . . .
Ending WAS . . . . . . . . . . . . . . . . . . . . . . . . . .
37
38
40
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . .
41
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
42
33
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Requirements . . . . . . . . . . . . . . . . . . . . . . . . . .
Before Every Use . . . . . . . . . . . . . . . . . . . . . . .
Setting SmartCare . . . . . . . . . . . . . . . . . . . . . .
Activating SmartCare . . . . . . . . . . . . . . . . . . . .
Course of the Patient Session . . . . . . . . . . . . .
Actions Performed on Evita XL and Their
Effects on SmartCare . . . . . . . . . . . . . . . . . . . .
Problems and Their Effects on SmartCare. . . .
12
12
13
16
17
18
19
Measured Values, Graphics, and Trends . . . 20
Displaying Graphics . . . . . . . . . . . . . . . . . . . . . 20
Displaying Measured Values . . . . . . . . . . . . . . 21
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 23
Selecting Initial Measured Values. . . . . . . . . . . 23
Ending SmartCare . . . . . . . . . . . . . . . . . . . . . 24
Alarm Messages and Related Actions . . . . . 25
Alarm – Cause – Remedy. . . . . . . . . . . . . . . . 26
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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New Features of SmartCare SW 1.1
New Features of SmartCare SW 1.1
Extended patient range
SmartCare can now also be used for patients with
a body weight between 15 and 36 kg. A supplementary medical guideline has been implemented
for this patient category. The relevant category is
selected based on the patient's body weight. The
patient’s weight is set on a separate page prior to
the start of each SmartCare session.
The dialog window changes according to the specific patient category and guideline selected. For
patients with a body weight of <36 kg, the "comfortable zone" for COPD and Neurologic Disorder
and the setting for ΔPASB goal pressure cannot be
adjusted. For this reason, the Medical History and
Airway Access pages do not appear in the case of
this patient category.
Use of SmartCare and ATC
ATC can be activated for patients weighing 36 kg or
more. In order to provide the most efficient compensation possible during a SmartCare Patient Session, the degree of compensation of ATC must be
set to 100 %.
Web-based Application Service (WAS)
SmartCare allows the user to view data from patient
sessions on a computer and to download it. This
application is web-based, i.e., it can work with
standard computer software and hardware.
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Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Any use of the medical device requires full understanding and strict observation of all portions of these Instructions for Use. The medical device is only to be used for the purpose
specified under "Intended Use" on page 7 and
in conjunction with appropriate patient monitoring (see "Patient monitoring" on page 6).
Strictly observe all WARNING and CAUTION
statements throughout these Instructions for
Use and all statements on medical device labels. Failure to observe these instructions is
to operate the medical device outside its intended use.
Networking
Device combinations approved by Dräger (see Instructions for Use of the individual devices or units)
meet the requirements set forth by the following
standards:
–
IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
–
IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
–
IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
–
IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Accessories
WARNING
Only the accessories indicated on the list of
accessories 9038780 (1st edition or higher)
have been tested and approved to be used
with the medical device. Accordingly it is
strongly recommended that only these accessories be used in conjunction with the specific
medical device. Otherwise the correct functioning of the medical device may be compromised.
If Dräger devices or units are connected to other
Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the
correct functioning of the devices may be compromised. The operator is responsible for ensuring that
the resulting system meets the requirements set
forth by the above standards.
Strictly follow Assembly Instructions and Instructions for Use for each networked device.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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For Your Safety and that of Your Patients
Patient safety
Patient monitoring
The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and
use of the medical device are restricted to trained
professionals, and that certain inherent characteristics of the medical device are known to the trained
operator. Instructions for use, WARNINGS and
CAUTION statements are therefore largely limited
to the specifics of the Dräger medical device.
This publication excludes references to various
hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can
be dangerous.
The operators of the medical device are responsible for choosing appropriate safety monitoring that
supplies adequate information on medical device
performance and patient condition.
Patient safety may be achieved through a wide variety of means ranging from electronic surveillance
of medical device performance and patient condition, to simple, direct observation of clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical device operator.
CAUTION
Danger to the patient.
Individual measured values and monitoring
parameters should not be used as the sole basis
for therapeutic decisions.
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Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 7
Application
Application
Intended Use
The SmartCare/PS system is designed to stabilize
the patient’s spontaneous breathing in a "comfortable zone", see page 29, and to reduce inspiratory
support automatically.
The medical expertise on which SmartCare is
based has been provided by specialists in intensive
care, see "Additional Explanations" on page 29 and
"Bibliography" on page 41.
SmartCare can be used for weaning intubated or
tracheotomized patients.
The requirements for operation must be met, see
"Indication" on page 7.
Patients with a body weight between 15 and <36 kg
must be endotracheally intubated and ventilated
using an active humidifier.
These Instructions for Use apply to Evita XL as well
as to Evita 4 and Evita 2 dura with the Evita XL option.
The patients should be hemodynamically stable,
sufficiently oxygenated and breathing spontaneously.
Indication
SmartCare/PS can be used on patients who are
suitable for weaning in the CPAP/ASB ventilation
mode. The indication required for use must be determined by the attending physician and/or the relevant person responsible.
SmartCare/PS assumes a physiological regulation
of breathing via the patient’s respiratory center. In
serious cases of COPD and/or neurological diseases impacting the respiratory center, a physiological
regulation of breathing via the patient’s respiratory
center is not possible or is only possible to a limited
extent. In these cases, the use of SmartCare/PS
should be carefully examined. If SmartCare/PS is
used, the patient must be observed closely.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
From a medical point of view, the
following conditions must be met
–
The decision to wean has been made.
–
The decision to wean in CPAP/ASB mode has
been made.
–
The decision to wean automatically using
SmartCare/PS has been made.
–
The patient has been assessed to be hemodynamically stable by the physician and/or by the
person responsible for the treatment.
–
The patient is able to breathe spontaneously.
–
The patient has a body weight (BW) between
15 kg and 200 kg.
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Application
From a technical point of view, the
following conditions must be met
–
Evita XL is set to the Adult or Pediatric patient
categories with the CPAP/ASB ventilation pattern.
–
The patient is being ventilated invasively
(intubated or tracheotomized).
–
The patient has a body weight (BW) between
15 kg and 200 kg.
–
For patients with a body weight of ≥36 kg:
– Endotracheal tube or tracheotomy tube
– Active breathing gas humidifier or HME/filter
–
For patients with a body weight of <36 kg:
– Endotracheal tube
– Active breathing gas humidifier
– Automatic tube compensation (ATC) is deactivated
–
Leakage compensation is activated.
–
Apnoea ventilation is active and set appropriately.
–
When using SmartCare/PS with activated automatic tube compensation (ATC), degree of
compensation must be set to 100 %.
–
Blue CO2 sensor CapnoSmart (6871500) is inserted and CO2 monitoring is activated.
–
Flow and if necessary NeoFlow monitoring is
activated.
–
PEEP can be set between 0 mbar and 20 mbar.
–
ΔPASB (above PEEP) is set in the range between ΔPASB goal and ΔPASB max.*.
NOTE
If SmartCare is started in the case of patients with
a ΔPASB outside this range, the PS is set to ΔPASB
goal or ΔPASB max. after the first classification.
*
For settings, see "Upper and Lower Limits of the Main
Parameters" on page 33
Recommended Settings for Alarm Limits
The attending physician is responsible for setting
the alarm limits on Evita XL according to the patient's needs.
Parameter
PAW
Alarm limit
MV
–25 % of current MV
MV
+25 % of current MV
fspn
40 bpm for a body weight of
≥36 kg
60 bpm for a body weight of
<36 kg
VTi
8
12 mL/kg body weight
42 mbar (≥36 kg)
29 mbar (<36 kg)
The following settings are recommended:
Parameter
Alarm limit
etCO2
18 mmHg
etCO2
57 mmHg (without COPD)
67 mmHg (with COPD)
TApnoea
60 seconds
The use of pulse oximetry is recommended so that
hypoxic patient conditions can be detected and an
alarm generated if the set pressure support is too
low.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Abbreviations and Terms
Abbreviations and Terms
Abbreviation/Term
Definition
ATC
Automatic Tube Compensation
bpm
Breaths per minute
BW
Patient’s body weight
Comfortable zone
The zone of respiratory parameters defined by spontaneous respiratory
rate, tidal volume, and end-expiratory CO2 concentration
COPD
Chronic Obstructed Pulmonary Disease, chronic bronchitis
CPAP/ASB
Spontaneous breathing with positive airway pressure
(Continuous Positive Airway Pressure) and pressure support for
individual breaths (Assisted Spontaneous Breathing)
Diagnosis
Classification of ventilation by SmartCare into one of eight different
diagnoses: Severe Tachypnea, Tachypnea, Central Hypoventilation,
Unexplained Hyperventilation, Insufficient Ventilation, Hypoventilation,
Normal Ventilation, Hyperventilation
ΔPASB
Relative pressure support (above PEEP) (set value)
ΔPASB goal
Minimum inspiratory pressure support specified for the respective patient
ΔPASB start
Inspiratory pressure support when starting a Patient Session
Duration
Duration of Patient Session
etCO2
End-expiratory CO2 concentration
fspn
Spontaneous respiratory rate
HME / Filter
Heated Moisture Exchanger
Interfering operations
User operations performed on Evita XL which may lead to a conflict with
SmartCare
MV
Minute volume, the volume breathed in one minute
PASB
Magnitude of inspiratory pressure support during ASB
Patient Session
Time during which pressure support is adjusted automatically
Patient Session journal
Record of the therapy session
PAW
Airway pressure
PEEP
Positive End-Expiratory Pressure
Phase
Weaning phases (Adapting, Observing, Maintain)
PS
Pressure Support
SC-etCO2
End-expiratory CO2 concentration established by SmartCare
SC-fspn
Spontaneous respiratory rate established by SmartCare
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Abbreviations and Terms
Abbreviation/Term
Definition
SC-PASB
ΔPASB is automatically set by SmartCare, but can be altered by the user at
any time
SC-VT
Tidal volume established by SmartCare
TApnoea
Duration of an apnea
Therapy rights
Right of medical or nursing staff to specify or undertake treatment
User
SmartCare user treating a patient
VT
Inspiratory tidal volume, leakage compensated
VTe
Expiratory tidal volume
VTi
Inspiratory tidal volume
WAS
Web-based Application Service
Weaning
Gradual reduction of ventilation support with the aim of eliminating its
necessity
Symbols
Symbol Explanation
Patient Session is running
Running Patient Session is interrupted.
SmartCare/PS is waiting for the end of
the condition that led to the interruption.
SC: Consider separation !
10
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Preparation
Preparation
Before First-time Use
Installing and activating the SmartCare option
May only be carried out by experts in accordance
with the corresponding installation instructions.
Switching on Evita XL
After switching on Evita XL, SmartCare takes
approx. 90 seconds to load. During this time,
SmartCare is not available.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Operation
Operation
Requirements
For the successful activation of a Patient Session,
the relevant requirements must be met.
See "Indication" on page 7.
Before Every Use
z Set CPAP/ASB ventilation mode, see Evita XL
Instructions for Use.
z Switch on CO2 monitoring and flow monitoring,
and, if necessary, NeoFlow monitoring, see
Evita XL Instructions for Use.
1
Touch the Add. settings tab (A).
2
Touch the ATC... tab (B).
Deactivating ATC
z Touch the Off button (C) and confirm with the
rotary knob.
z Set automatic tube compensation (ATC) accordingly, see page 12.
z Activate Apnoea ventilation, see page 13.
Setting degree of compensation
Automatic Tube Compensation (ATC)
z Deactivate ATC for patients with a body weight
of <36 kg.
1
Touch the Comp. therapy control (D).
2
Using the rotary knob, set the value to 100 %
and confirm.
Activating ATC
z In the case of a body weight of ≥36 kg, ATC can
be activated. The degree of compensation must
be set to 100 %.
z Touch the On button (E) and confirm with the rotary knob.
In the Ventilator Settings dialog window:
B
E
C
A
001
D
12
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 13
Operation
Activating Apnoea ventilation
Evita XL displays the settings for Apnoea ventilation.
In the Ventilator Settings dialog window:
Setting values:
B
E
D
1
Touch the Add. settings tab (A).
2
Touch the Apnoea ventilation... tab (B).
Touch the VT (C) and f (D) therapy controls.
2
Set and confirm the values with the rotary knob.
Activating Apnoea ventilation:
A
002
C
1
z Touch the On button (E) and confirm with the rotary knob.
Evita XL displays the status of Apnoea ventilation in
the header bar.
Setting SmartCare
Entering the body weight
When all requirements for a Patient Session are
met, the user must make further settings. These
settings serve to individually adjust SmartCare/PS
to the patient.
In the Ventilator Settings dialog window:
Displaying settings
1
Press
1
Touch the SmartCare tab (A).
2
Touch the Patient Weight tab (B).
Ventilator Settings key.
B
The Ventilator Settings dialog window is opened.
2
Touch the SmartCare tab (A).
A
020
C
B
C
D
003
A
3
Touch the Weight (C) therapy control.
4
Using the rotary knob, set the body weight of
the patient and confirm the value.
In the Paed. patient category, only a body weight
of up to <36 kg can be set.
Evita XL displays the current settings.
In the case of a body weight of <36 kg, only
Patient Weight (B), Night Rest (C), and
Patient Session (D) are displayed.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Operation
Entering Airway Access
Entering Medical History
In the Ventilator Settings dialog window:
On the Medical History page, additional information
on the patient’s underlying diseases can be entered. These entries are only possible for patients
with a body weight of ≥36 kg. Based on these entries, SmartCare determines the values fspn high,
etCO2 high and VT low, see "Upper and Lower Limits of the Main Parameters" on page 33.
1
Touch the SmartCare tab (A).
2
Touch the Airway Access tab (B).
B
A
004
C
D
The set types of Humidification (C) and
Intubation (D) are displayed.
Based on these settings, SmartCare determines
the value for ΔPASB goal, see "Upper and Lower
Limits of the Main Parameters" on page 33.
WARNING
The function of SmartCare is based on the patient’s respiratory control function working.
For patients with serious COPD or a serious
neurological disorder, this control function is
sometimes insufficient. In these cases, check
the function of SmartCare by observing the
patient!
The ΔPASB value may reach the limits which
are determined by PAW high and MV low.
z Enter the type of Humidification, see Evita XL
Instructions for Use.
In the Ventilator Settings dialog window:
Enter the type of Intubation (D):
1
Touch the SmartCare tab (A).
1
Touch the ET tab (endotracheal tube) or Trach.
tab (tracheostomy tube).
2
Touch the Medical History tab (B).
2
Use the rotary knob to confirm.
B
A
005
C
D
Enter the patient’s Medical History data:
– Neurologic Disorder (C)
– COPD (D)
14
3
Touch the relevant button Yes or No.
4
Use the rotary knob to confirm.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 15
Operation
Setting Night Rest
In the Ventilator Settings dialog window:
1
Touch the SmartCare tab (A).
2
Touch the Night Rest tab (B).
B
D
A
006
C
E
F
When Night Rest is activated, SmartCare will not
actively reduce the ΔPASB for weaning purposes
during the set period of time. The period of time can
be changed at any time, also during Night Rest.
Activating or deactivating Night Rest:
1
Touch the Yes (C) or No (D) button.
2
Use the rotary knob to confirm.
Setting the period of time:
1
Touch the Begin (E) and End (F) buttons.
2
Set and confirm the times with the rotary knob.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Operation
Activating SmartCare
Display:
SmartCare can only be activated if
– ATC is deactivated for patients with a body
weight of <36 kg, see "Automatic Tube Compensation (ATC)" on page 12.
– Apnoea ventilation is activated.
– CO2 monitoring is activated.
– Flow and if necessary NeoFlow monitoring is
activated.
– Leakage compensation is activated.*
E
In the Ventilator Settings dialog window:
1
Touch the SmartCare tab (A).
2
Touch the Patient Session tab (B).
F
008
D
All measured values relating to SmartCare are displayed in a separate color.
B
3
Touch the On button (C) and confirm with the
rotary knob.
SmartCare is activated.
Calling additional information texts on SmartCare.
z Touch the
button (D).
007
C
SmartCare (E) is displayed in the header bar.
A
The symbol
is displayed next to the ΔPASB (F)
therapy control.
When SmartCare is activated, the following settings cannot be changed:
– Airway Access
– Medical History
– ATC on/off
– ATC degree of compensation
– Apnoea ventilation on/off
– Date/time
– Tube application mode
ΔPASB can be changed by the user at any time.
*
16
For additional information, see "Leakage compensation"
on page 30.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 17
Operation
Course of the Patient Session
–
The user verifies whether the patient complies
with the physiological requirements (see "Indication" on page 7).
–
Ventilation parameters and alarm limits are set
according to the patient’s needs.
–
SmartCare first attempts to stabilize the patient’s spontaneous respiratory rate by adjusting the pressure support.
–
Pressure support is regularly adapted to the patient’s respiratory profile (characterized by
spontaneous respiratory rate, tidal volume, and
end-expiratory CO2 concentration).
–
On the basis of these values, SmartCare carries
out a classification of the ventilation every
2 minutes or 5 minutes.
–
When pressure support reaches a minimum
value (defined by "Type of Intubation", "Type of
Humidification" and "ATC on/off"), SmartCare
conducts a test that is equivalent to a spontaneous breathing test.
–
Once the observation phase is concluded successfully, the system informs the user that the
patient can be disconnected from Evita XL.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Operation
Actions Performed on Evita XL and Their Effects on SmartCare
If certain ventilation parameters must be changed
for medical reasons during a Patient Session, this
might lead to an interruption of the Patient Session,
see page 31. After a Patient Session is interrupted,
Evita XL continues ventilation with the last values
set by SmartCare.
The symbol
appears on the screen when
SmartCare is waiting for a procedure or alarm condition to be ended.
If the user adjusts ΔPASB, SmartCare resumes the
Patient Session with this new value. The user can
"override" SmartCare in this way. The change is indicated in the logbook with the symbol
.
Response of the SmartCare system to user
actions:
Touch the O2↑ suction button
Wait for the procedure to end
Calibration of the CO2 sensor
Wait for the procedure to end
Change to standby mode
Interrupts Patient Session1)
Change of ventilation mode
Interrupts Patient Session
PEEP adjustment
Patient Session is interrupted if PEEP >20 mbar
Patient Session is interrupted during the observation phase if
PEEP >5 mbar
Switching off flow monitoring
Interrupts Patient Session
Switching off CO2 monitoring
Interrupts Patient Session
Change to
Mask Ventilation
application mode (NIV)
Interrupts Patient Session
1)
18
This alarm only appears after ending standby mode.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 19
Operation
Problems and Their Effects on SmartCare
Problems with the patient or the device necessitating changes in the basic ventilation parameters or
settings of Evita XL trigger alarms and can also
cause premature termination of the Patient Session. See "Alarm Messages and Related Actions"
on page 25.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
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Measured Values, Graphics, and Trends
Measured Values, Graphics, and Trends
Displaying Graphics
Displaying 1 hr trend
1
Touch the
bar.
F
E
G
Main button (A) in the main menu
C
B
A
010
D
009
Evita XL displays the trend over the last hour. The
diagnoses are displayed in different colors to the
left of the scale, see page 22.
2
Touch the relevant button
3
Touch the Trends tab (C).
(B).
Evita XL opens the page for selecting the parameters for the trend display. If SmartCare is available,
Evita XL will also offer the parameters Diagnosis
and SC-PASB.
4
20
Touch the Diagnosis button (D).
To display a diagnosis for a particular point in
time:
z Turn the rotary knob to position the cross-hair
cursor (E) over the required point.
Evita XL displays the diagnosis at the top of the
trend display (F).
The cross-hair cursor cannot be moved if the trend
display has been frozen with the
Freeze
button (G).
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 21
Measured Values, Graphics, and Trends
Displaying Measured Values
Displaying the logbook
When SmartCare is available, Evita XL displays
values, logbooks, and trends on separate pages.
1
Displaying measured values and
settings
1
Touch the Data ... button in the main menu bar.
D
A
G
E
Touch the Data ... button in the main menu bar.
A
B
C
C
012
F
011
B
Evita XL opens the Data dialog window, the Values
page (A) is selected by default.
2
Touch the SmartCare tab (B).
The status of the current Patient Session and the
set Basic Patient Data are displayed.
The values for SC-fspn, SC-VT and SC-etCO2 are
mean values between the individual ventilation
classifications.
z Touch the X (C) button to close the display.
2
Touch the Logbook tab (A).
3
Touch the SmartCare tab (B).
Changes, events and alarms in the Patient Session
are listed in a table with the respective date and
time.
If ΔPASB has been modified by the user, Evita XL
displays the new value with the symbol
.
Buttons (C) for navigating within the logbook:
First entry in logbook
Scroll back to the preceding hour
Scroll forward to the next hour
Last entry in logbook
When changing to the Values (D) or Trends (E)
pages, the same point in time is displayed with the
corresponding data.
SmartCare events (F) are displayed for each logbook entry.
z Touch the X (G) button to close the logbook.
Logbook data is retained until the next Patient Session starts.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
21
Page 22
Measured Values, Graphics, and Trends
Displaying (1 to 24 hr) trends
The value is displayed to the right of the trend display (F).
1
When changing to the Values (G) or Logbook (H)
pages, the same point in time is displayed with the
corresponding data.
Touch the Data ... button in the main menu bar.
G
H
J
A
z Touch the X (J) button to close the trend display.
D
C
B
E
2
Touch the Trends tab (A).
3
Touch the SmartCare tab (B).
013
F
Evita XL displays the Trends for Diagnosis and
SC-PASB.
The possible diagnoses are listed to the right of the
scale (C). The current ventilation Diagnosis is highlighted in color.
Diagnoses are displayed in different colors to the
left of the scale (D).
orange = Inspiratory support is maintained or
increased.
green
= The patient will be gradually weaned.
light
green
= The patient is hyperventilated,
inspiratory support is gradually being
reduced.
Select time scale in increments of 1, 3, 6, 12, 24 h:
z Touch the button for the required time scale (E).
The button turns green and the corresponding time
scale is now effective.
Displaying a trend value at a certain point in time:
z Turn the rotary knob to position the cross-hair
cursor over the point in time.
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Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 23
Configuration
Configuration
For selecting the display of measured values, also
see Evita XL Instructions for Use.
Selecting Initial Measured Values
1
Press the
1
2
3
System Setup key.
The System page (A) appears by default.
2
Touch the Screen tab (B).
3
Touch the Values... tab (C).
A
D
E
F
C
B
015
G
To display measured values with their effective
alarm limits, the three selections can be customized specifically as required by hospital protocol.
1 2 3
1 2 3
In the
Group 1 (D),
Group 2 (E) or
1 2 3
Group 3 (F) column:
4
Touch the relevant button.
Evita XL opens the selection list of parameters (G).
If SmartCare is available, specific parameters can
be selected. These parameters can only be displayed as individual values.
For an explanation of SmartCare parameters, see
"Abbreviations and Terms" on page 9.
5
Select and confirm the parameter (G) using the
rotary knob.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
23
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Ending SmartCare
Ending SmartCare
If weaning has been successful, SmartCare displays the message
SC: Consider separation !
and the symbol
.
Following evaluation of the patient’s clinical condition, the patient can be separated from the ventilation system.
Ending the Patient Session
In the Ventilator Settings dialog window:
1
Touch the SmartCare tab (A).
2
Touch the Patient Session tab (B).
B
3
A
014
C
Touch the Off button (C) and confirm with the
rotary knob.
The Patient Session is ended.
After Interruption of a Patient Session
Evita XL continues to ventilate the patient with the
last values set by SmartCare. These values may
need to be corrected as indicated by the patient’s
clinical condition.
Upon completion of the Patient Session, therapy
data is retained until the start of the next Patient
Session. SC measured values and SC data in currently visible measured values fields are displayed
with _ _ _.
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Instructions for Use SmartCare/PS SW 1.1 for Evita XL
Page 25
Alarm Messages and Related Actions
Alarm Messages and Related Actions
The alarm messages displayed by Evita XL have
the following effects on SmartCare:
Alarm message
Action
Airway pressure high !!!
Interrupts the Patient Session and waits (possibly a cough)
Airway pressure low !!!
Interrupts the Patient Session and waits
Apnoea ventilation !!
Ends the Patient Session and Evita XL continues ventilation
ASB > 4 s !!!
Interrupts the Patient Session and waits
Breathing cycle not detected !!!
Ends the Patient Session and Evita XL continues ventilation
Check settings !!
Interrupts the Patient Session and waits
Clean CO2 cuvette !!!
Interrupts the Patient Session and waits
CO2 measurement inop. !!!
Interrupts the Patient Session and waits
CO2 sensor ?!!!
Interrupts the Patient Session and waits
CO2 zero ?!!!
Interrupts the Patient Session and waits
Device failure 00.00.000 !!!
Ends the Patient Session and Evita XL continues ventilation
Exp. valve faulty !!!
Interrupts the Patient Session and waits
Flow measurement inop. !!!
Interrupts the Patient Session and waits
Flow sensor ?!!!
Interrupts the Patient Session and waits
Leakage !
Interrupts the Patient Session and waits
Neo. flow sensor ?!!!
Interrupts the Patient Session and waits
PEEP valve inop. !!!
Interrupts the Patient Session and waits
Pressure meas. inop. !!!
Interrupts the Patient Session and waits
Explanation of terms
"Ends the Patient Session"
"Interrupts the Patient Session"
Ends automatically. Cannot be influenced by the
user.
SmartCare is displayed in the header bar.
SmartCare waits for the end of the condition triggering the interruption and does not change the pressure support level during this time. When the condition ends, SmartCare starts to collect data again,
performs classification and resumes control of the
pressure support.
Instructions for Use SmartCare/PS SW 1.1 for Evita XL
25