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.