Dräger Infinity Acute Care System Workstation Critical... User manual

Supplement to
instructions for use
SW 2.n
WARNING
To properly use this medical device,
read and comply with the instructions
for use and this supplement.
Status: Draft, 5. March 2015 08:47
– Infinity Acute Care System
Workstation Critical Care and
Neonatal Care
– Infinity Acute Care System
Evita Infinity V500
– Infinity Acute Care System
Babylog VN500
–EvitaV300

2
Supplement to instructions for use
This supplement applies only to the listed medical
devices and updates the information of the respec-
tive instructions for use. Each chapter indicates the
medical devices to which the information applies.
Keep this supplement with the current instructions
for use of the respective medical device.
Where changes to screen content affect all of the
medical devices, the screen is displayed which
shows the maximum number of functions.
Devices delivered as of July 22, 2014 meet the re-
quirements of the 3rd edition of the IEC 60601-1
standard.
Typographical conventions
Applies to:
– Workstation Critical Care and Neonatal Care
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Use of terms
Dräger uses the term "Accessory" not only for ac-
cessories in the sense of IEC 60601-1, but also for
consumable parts, removable parts, and attached
parts.
The designation "Infinity Acute Care System" is
omitted hereafter in this document.
Medical device Part number of
instructions for use
Infinity Acute Care System
Workstation Critical Care and Neonatal Care
9052077
Infinity Acute Care System
Evita Infinity V500
9052161
Infinity Acute Care System
Babylog VN500
9038982
Evita V300 9052995

3
For your safety and that of your patients
For your safety and that of your patients
General safety information
Applies to:
– Workstation Critical Care and Neonatal Care
– Evita Infinity V500
– Babylog VN500
– Evita V300
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying docu-
ments of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices can be compromised. The operating or-
ganization must ensure that the device combination
complies with the applicable editions of the relevant
standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software-con-
trolled functions)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general require-
ments for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-4 (software-controlled func-
tions)
– IEC 60601-1-8 (alarm systems)
Training
Training for users is available via the Dräger organ-
ization responsible (see www.draeger.com).

For your safety and that of your patients
4
Product-specific safety information
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
WARNING
Risk of malfunction
Unauthorized modifications to the medical de-
vice lead to malfunctions.
This medical device must not be modified un-
less authorized by the manufacturer.
WARNING
Risk of fire
The use of unapproved O2pressure reducers
can lead to excess pressure which can cause
a fire.
When supplying the ventilator with oxygen
from a compressed gas cylinder, only use
pressure reducers compliant with ISO 10524.
Slowly open the pressure reducer manually.
Do not use tools.
WARNING
Risk of unnoticed change in inspiratory O2
concentration
If an additional flow is delivered by an external
flow source, the actual O2concentration deliv-
ered may deviate from the displayed values.
Use additional monitoring, e.g., external SpO2
monitoring, if necessary.
WARNING
Risk of patient injury
If leakages are present, e.g., with non-invasive
ventilation, the actual tidal volume may devi-
ate from the measured values for VTe and VTi.
Activate leakage compensation and monitor
the measured value for VT. Minimize or rem-
edy all leakages.
CAUTION
Risk of patient injury
An additional flow delivered by an external flow
source can affect the measured values for airway
pressure and flow.
CAUTION
Risk of malfunction
The touch screen has a sensitive surface. Dam-
age to the surface may cause the touch-sensitive
controls not to work properly.
Do not operate the screen with sharp objects.

5
Application
Application
Applies to:
– Evita Infinity V500
– Babylog VN500
– Evita V300
Environment of use
Do not operate the device with helium or helium
mixtures.

Overview
6
Overview
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Range of functions
Connecting accessories
Accessories can be attached to the following hold-
ers:
– Universal holder with standard rail (G93140)
– Humidifier holder, can be swiveled (G93111)
– Humidifier holder, side rail (8416325)
Observe the permitted maximum distance to the
trolley and the permitted maximum load, see "Max-
imum loads of holders" on page 8.
Abbreviations
Abbreviation Explanation
BTPS Body Temperature Pressure Satu-
rated, measured values based on
the condition of the patient's lungs,
body temperature 37 °C (98.6 °F),
water vapor-saturated gas, ambi-
ent pressure and airway pressure
Vds Serial dead space,
volume up to CO2cuvette

7
Overview
Symbols
Symbol Explanation
Attention!
Warning! Strictly follow these
instructions for use.
Label with notice: "Transport
within the hospital"
Nominal weight and maximum
weight (for information, see
chapter "Technical data")
Temperature limitation during
storage
Ambient pressure
Relative humidity
Use by
Keep dry
nom. 58 kg (128 lbs)
max. 133 kg (293 lbs)

Assembly and preparation
8
Assembly and preparation
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Safety information
Prepare trolley 2 – 90 cm
Securing accessories to the standard
rail
Maximum loads of holders
The following information applies to the holders:
WARNING
Risk of tipping over
Do not tilt the device by more than 5°.
Holder Position of the holder Maximum
load
Possible accesso-
ries
Maximum distance
to side rail
Universal holder
with standard rail
(G93140)
On the front of the trol-
ley
10 kg
(22 lbs)
Breathing gas humid-
ifier, medication neb-
ulizer
–
Humidifier holder,
can be swiveled
(G93111)
On the side of the trolley 5 kg
(11 lbs)
Breathing gas humid-
ifier
–
Humidifier holder,
side rail (8416325)
On the side rails of the
ventilation unit1)
1) Maximum load on the side rails of the ventilation unit: 5 kg (11 lbs) per side rail
5kg
2)
(11 lbs)
2) If a hinged arm is attached to the side rails of the ventilation unit in addition to the humidifier holder (8416325), the maximum
load of 5 kg (11 lbs) per side rail must be observed. The humidifier holder can then only support 4 kg (8.8 lbs).
Breathing gas humid-
ifier
10 cm (3.9 in)
IACS hinged arm
(MP00690)
On the side rails of the
ventilation unit1)
1kg
(2.2 lbs)
Breathing hoses 100 cm (39.4 in)

9
Assembly and preparation
Preparing the Medical Cockpit
Using the MEDIBUS or the MEDIBUS.X
protocol
Preparing the ventilation unit
Safety information for the use of HMEs,
bacterial filters, and breathing circuits
Installing a neonatal flow sensor
If a neonatal flow sensor and HME are used in the
patient categories Neo. or Ped. pat., the HME must
be installed between the neonatal flow sensor and
the patient connection.
WARNING
Risk of patient injury
All data transferred via the MEDIBUS interface
are for information only and must not be used
as the sole basis for diagnostic or therapeutic
decisions. The MEDIBUS interface is not in-
tended for use with a distributed alarm system
according to IEC 60601-1-8:2012.
CAUTION
Additional components in the breathing circuit
such as bacterial filters, HME or CO2cuvettes
may increase the dead space, compressible vol-
ume, and resistance.
Particular care and monitoring are required when
using additional components.
Before checking the breathing circuit (see instruc-
tions for use, chapter "Getting started"), attach all
necessary additional components up to the pa-
tient connection.
WARNING
Increased resistance
Medication nebulization and active humidifi-
cation may increase the resistance of addi-
tional components.
Check the breathing circuit regularly for signs
of increased resistance and replace additional
components if necessary.

Assembly and preparation
10
Connecting the mains power supply
Connecting the nurse call
Transportation of patients within the hospital
When transporting the patient within the hospital,
grasp the trolley handle firmly and push the device
in longitudinal direction.
WARNING
Risk of electric shock and of device failure
If the device is connected to a power socket
with incorrect mains voltage or without a pro-
tective ground, the user can be injured and the
device damaged.
Only connect the power cable to power sock-
ets with a protective ground and the correct
mains voltage. Observe the technical data.
NOTE
The mains power socket in use must be freely ac-
cessible during operation.
WARNING
Risk of patient injury
All data transferred via the nurse call are for
information only and must not be used as the
sole basis for diagnostic or therapeutic deci-
sions. The nurse call is not intended for use
with a distributed alarm system according to
IEC 60601-1-8:2012.

11
Assembly and preparation
Transport within the hospital
Transport refers to any movement of the medical
device without the patient that does not serve to po-
sition the medical device.
Increasing the tipping stability
zSwivel the control and display unit (Medical
Cockpit) until it is centrally aligned with the ven-
tilation unit.
zSet the hinged arms to minimum extension.
zDrain the water container of the breathing gas
humidifier.
zSecure the breathing gas humidifier to the trol-
ley, not to the side rails of the ventilation unit.
zDo not attach any additional parts to the side
rails of the ventilation unit.
zIf fitted, slide the bed coupling into its retracted
position.
zGrasp the trolley handle firmly and push the de-
vice in longitudinal direction.
Safety information for patient transport within the
hospital also applies, see instructions for use.

Getting started
12
Getting started
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
The Start/Standby > Start/Standby page is
organized as follows:
– The text on the combined button (A) changes
depending on the mode in use:
– Standby
– Start ventilation
– The results of the last system check are
displayed (B).
The Start/Standby dialog window cannot be
closed with the X button (C).
Checking readiness for operation
Performing the breathing circuit check
Starting the breathing circuit check
Prerequisite: The page System check (A) >
Breathing circ. check (B) is open. The check has
been started.
4When requested by the device in the instruction
field (E): Seal the patient connection port,
e.g., with a sterile glove. Confirm with OK (F).
5When requested, open the patient connection
port. Confirm with OK (F).
125
Start/Standby
AB
C
103_neu
Start/Standby
A
B
E
F
C
D

13
Getting started
Display of results of the breathing circuit check
Prerequisite: The System check page (A) is
opened.
zTouch the Check results tab (B).
The detailed results of the check are displayed.
Checking the switch to battery operation
zUnplug the mains plug.
The device switches to battery operation without in-
terruption. The Battery activated alarm is dis-
played.
zPlug the power cable back in.
The device switches back to mains operation. The
Battery activated alarm message goes out.
Checking the alarm signaling
When the system check has been successfully com-
pleted, the device is ready for operation. The alarm
signaling can also be checked. The description of
alarm signaling can be found in the instructions for
use in chapter "Alarms." Additional information on
alarm criteria can be found in the instructions for use
in chapter "Alarm – Cause – Remedy."
High-priority alarm message
1Start ventilation.
2After 2 minutes set the upper alarm limit for
MVe to a value below the measured value MVe.
The MV high alarm is triggered.
Medium-priority alarm message
For Evita Infinity V500 and Evita V300:
1Start ventilation.
2Set the upper alarm limit for VT to a value below
the measured value VT.
The VT high alarm is triggered.
For Babylog VN500:
1Start ventilation.
2Switch on the additional setting Volume Guar-
antee .
3Reduce the upper alarm limit for Paw until the
VT not reached, Pmax active alarm is trig-
gered.
Low-priority alarm message
1Start ventilation.
2In the Special maneuvers > Maneuvers dialog
window, press and hold the Man. insp./hold
button until the Inspiratory hold interrupted
alarm is triggered.
103_2
CCompliance [mL/mbar]
DFlow [L/min]
EInspiratory resistance [mbar/L/s]
FExpiratory resistance [mbar/L/s]
Start/Standby
C
A
B
DEF

Getting started
14
Checking alarm limits
The alarm limits for a settable alarm can be
checked by setting the alarm limits appropriately.
When the alarm limit is exceeded, the correspond-
ing alarm is triggered. Additional information on set-
ting alarm limits can be found in the instructions for
use, chapter "Setting alarm limits."
Test of the acoustic alarm system
The acoustic alarm system need not be tested by
the user. The device tests the functions of the
acoustic alarm system automatically during the de-
vice check.

15
Operation
Operation
Setting ventilation
Applies to: Babylog VN500
Additional settings for ventilation
Ventilation parameters for the additional set-
tings
(
CAUTION
Undetected worsening of the patient's condition
During high-frequency ventilation with Volume
Guarantee, the ventilator automatically compen-
sates for changes in lung mechanics. As a result,
a gradual worsening of patient condition may only
be detected after a delay.
Observe patient condition. Check ventilation pres-
sure regularly and set the alarm limits accordingly.

Operation
16
Special maneuvers
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Oxygen enrichment for suction
maneuver
Closed suction
WARNING
Risk of patient injury during suction in a
closed breathing circuit
Using closed suction systems produces neg-
ative pressure in the patient's airways. This
leads to impaired ventilation and therefore to
impaired gas exchange.
Observe patient condition.

17
Operation
Medication nebulization
Applies to:
– Evita Infinity V500
– Babylog VN500
– Evita V300
Safety information on medication
nebulization
Continuous medication nebulization
Prerequisite: The Special maneuvers >
Nebulization page is open.
zPress the (A) button.
Continuous medication nebulization is started. The
message Continuous nebulization in progress.
is displayed.
Medication nebulization is interrupted every
30 minutes and the flow sensor is calibrated. After
the flow sensor has been calibrated, medication
nebulization is continued.
When medication nebulization is used in the patient
category Neo. or Ped. pat. and the neonatal flow
sensor has thus been removed, medication nebuli-
zation is not interrupted.
If the parameter field for continuous nebulization
Cont. neb. has been configured for display, the du-
ration of medication nebulization is displayed.
Mains power supply / DC power supply
Applies to:
– Evita Infinity V500
– Babylog VN500
– Evita V300
Battery charging
The battery charge display applies to both charging
and discharging.
CAUTION
Ventilation impaired
If unapproved pneumatic medication nebulizers
are used, the actually delivered tidal volume and
O2concentration may deviate from the displayed
values.
Only use the medication nebulizers listed in the
current list of accessories.
CAUTION
Ventilation impaired
Aerosols can impair the proper functioning of the
expiratory valve.
When using medication nebulization, shorten the
reprocessing cycles for the expiratory valve.
086_neu
∞
Special maneuvers
A

Monitoring
18
Monitoring
Flow monitoring
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Calibrating Infinity ID flow sensors
Applies to:
– Evita Infinity V500
–EvitaV300
Starting the calibration of the Infinity ID flow
sensor
1Touch the Sensors/ Parameters... button in the
main menu bar.
The device opens the Sensors/Parameters dialog
window.
2Touch the Flow sensor tab (A).
3Touch the Start button (B).
4The device displays information about the
calibration in field (D). Button (E) is preselected.
Confirm with the rotary knob.
The device uses the next inspiratory phase for
calibration of the Infinity ID flow sensor. Short
inspiratory times are extended to
approximately 1 second.
The device displays information about the
calibration in the message field (C).
At the completion of calibration, the Start button (B)
turns pale green.
WARNING
Risk of fire
Residual vapors of easily flammable
disinfectants (e.g., alcohols) and deposits that
were not removed during reprocessing can
ignite when the flow sensor is in use.
– Ensure particle-free cleaning and
disinfection.
– After disinfection, allow the flow sensor to
air for at least 30 minutes.
– Before inserting the flow sensor check for
visible damage and soiling, such as
residual mucus, medication aerosols, and
particles.
– Replace flow sensors when damaged,
soiled, or not particlefree.
110
A
B
E
C
Sensors/Parameters
D

19
Alarms
Alarms
Applies to:
– Evita Infinity V500
– Babylog VN500
– Evita V300
Displaying information on alarms
Acknowledging alarm messages
Alarm messages that can be acknowledged are
listed in the instructions for use in chapter "Alarm –
Cause – Remedy." For alarm messages that can
be acknowledged the "Remedy" column in the table
contains the information that the alarm message
can be acknowledged by pressing the ALARM RE-
SET button and confirming with the rotary knob.
The following alarm messages that can be ac-
knowledged are not listed:
– Suction maneuver overused?
–PEEP high (!!)
–Flow sensor? Ventilation impaired
(Evita Infinity V500, Evita V300)
–Low Flow PV Loop maneuver overused?
(Evita Infinity V500)
Alarm history
The alarm history is part of the logbook. The length
of the alarm history depends on the number of log-
book entries.
When the logbook reaches its maximum size, the
oldest entry in the logbook is deleted as each new
entry is logged.
Switching the device off and on are not recorded in
the logbook.
Setting the volume of the alarm tone
The lower value for the volume of the alarm tone is
limited by the configured minimum volume of the
alarm tone. The minimum volume is configured on
page System setup > Alarms > Alarm vol./tone,
see chapter "Setting the alarm tone" on page 20.
WARNING
Missing alarms in loud environments
Alarm situations are not detected.
Set the volume of the alarm tone so that
alarms can be heard.

Configuration
20
Configuration
Applies to:
– Evita Infinity V500
– Babylog VN500
–EvitaV300
Information on configuration
The Exchange intervals page has been renamed to
System status. Information on the exchange inter-
vals can be found at System setup > System sta-
tus > Exchange intervals. Additional information
regarding the System status page can be found on
page 22.
The System status page is password-protected.
Configuring alarm settings
Setting the alarm tone
Setting the minimum alarm volume
Configuring the minimum alarm volume sets the
lower limit of the factory setting for the volume of
the alarm tone (10 % to 100 %). This allows the
setting range to be adjusted to the acoustical situa-
tion at operation site.
Prerequisite: The System setup > Alarms >
Alarm vol./tone page is opened.
1Touch the (A) button.
2Set the value for the minimum volume by turn-
ing the rotary knob and push to confirm.
WARNING
Missing alarms in loud environments
Alarm situations are not detected.
Set the volume of the alarm tone so that
alarms can be heard.
149_neu
System setup
A
BC
DE