Dräger Evita 2 User manual

Evita 2
Intensive Care Ventilator
Instructions for
Software 1.n Use
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Contents
Page
For Your Safety and that of Your Patients.. .............. .3
Intended Use.. ........................................................... 4
Monitoring Ventiletion.. ............................................. .6
Preparation.. .............................................................. 7
Fitting patient system.. .............................................. 7
Fitting flow sensor.. .................................................. .7
Fitting 02 sensor.. .................................................... .8
For Ventilating Adults and Children.. ...................... .9
Connecting Aquapor humidifier.. ............................... 9
Connecting ventilation hoses.. .................................. .Q
Fitting temperature sensor.. ..................................... 10
For Ventilating Infants.. ......................................... .1 1
Electrical supply.. .................................................... 12
Connection to other equipment.. ............................. .12
Temporary interruption of power.. ........................... .13
Gas supply.. ........................................................... .13
Operating for the first time.. ................................. .14
Calibration.. ........................................................... .17
Calibrating 02 sensor.. ........................................... .17
Calibrating flow sensor.. ......................................... .lQ
Equipment Check.. ................................................ 20
Operation.. ............................................................... 21
Switching on........................................................... 21
Selecting adult or paediatric ventilation.. ................. .22
Basic setting of mandatory pattern of ventilation.......2 3
Optimising basic setting.. ........................................ 24
Pressure limited ventilation PLV.. ............................ .25
Pressure controlled ventilation PCV.. ...................... .25
Conrrolled ventilation IPPVKPPV.. ......................... 26
lnversed ratio ventilation IRV.. ................................. .29
Switching on sigh.. ................................................. .30
Setting BIPAP.. ................... :.:...i.. .......................... :31
Synchronised intermittent mandatory
ventilation SIMV.. .................................................... 33
Assisted spontaneous breathing ASB.. ................... .35
Setting apnoea ventilation.. ..................................... .37
Other ventilation modes.. ........................................ .36
BIPAP-SIMV.. ......................................................... 39
BIPAP-APRV.. ................................................. ....... .42
Mandatory minute volume ventilation MMV.. ............ .44
Setting independent lung ventilation ILV.. ................ .46
Setting alarm limits.. ................................................ 51
Selecting measured value displays.. ........................ 53
Manual start and/or inspiration hold.. ...................... .56
Medicament nebulization.. ....................................... 57
Oxygen enrichment for bronchial suction ................. 59
Selecting screen displays.. ..................................... .61
Page
Recalling status pages.. .......................................... .63
Menu functions.. .................................................... 64
Menu summary.. ..................................................... .66
Setting volume warning.. ......................................... 67
Setting tachypnoea monitoring ................................ .66
Setting sigh.. .......................................................... .70
Setting flow trigger.. ............................................... .71
Selecting measurement manoeuvre.. ....................... 72
Selecting adult or paediatric ventilation.. ................. .76
Adjusting contrast and setting date/time.. ................ 77
Regular routines.. ................................................... .79
Alarms.. ................................................................. 60
Recommendations on settings.. .............................. .61
Shut-down.. ............................................................ 65
Care......................................................................... .66
Stripping down.. ..................................................... .66
Disinfecting/Cleaning.. ............................................ 66
Sterilizing.. .............................................................. QO
Testing Readiness for Operation.. .......................... .92
Maintenance Intervals ............................................ 101
Replacing cooling-air filter.. ................................... 102
Correct disposal of batteries, accumulators
and electrochemtcal sensors.. ............................... 102
Removing and replacing ambient-air filter.. ............. 103
Fault - Cause - Remedy.. ..................................... 104
What’s What ........................................................... 107
Technical Data.. ..................................................... 111
Description.. .......................................................... .l 17
Sigh-
....................................................................... 117
SIMV, Synchronised Intermittent Mandatory
Ventilation ............................................................. 116
ASB, Assisted Spontaneous Breathing.. ............... ,120
BIPAP, Biphasic Positive Airway Pressure.. .......... ,122
Using BIPAP.. ....................................................... 123
Using BIPAP-SIMV.. ............................................. 124
Using BIPAP-APRV.. ............................................ .125
MMV, Mandatory Minute Volume Ventilation.. ........ 126
Measurement of occlusion pressure.. ................... .127
Measurement of intrinsic PEEP.. ........................... 126
Abbreviations and symbols used.. ......................... 129
Literature.. ............................................................ 132
Parts List.. .............................................................. 133
Order List.. ............................................................. 135
Index ..................................................................... 139
2

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For Your Safety and that of Your
Patients
For correct and effective use of the apparatus and to
avoid hazards it is essential to read the following recom-
mendations and to act accordinglyt):
Strictlyfollow the Instructions for Use
Any use of the apparatus requires full understanding and
strict observation of these instructions. The apparatus is
only to be used for purposes specified here.
Maintenance
The apparatus must be inspecteds) and serviced’4 regu-
larly by trained service personnel at sb: monthly intervals
(and a record kept).
Repairs) and general overhaul of the apparatus may only
be carried out by trained service personnel.
We recommend that a service contract be obtained with
DragerService and that all repairs also be carried out by
them. Only authentic Drager spare parts may be used for
maintenances).
Observe chapter ‘Maintenance Intervals’.
Power connection
The apparatus is to be used only in rooms with mains
power supply installations complying with national safety
standards (such as in F. R. of Germany: VDE 0107).
The requirements laid down in IEC 601-l ‘Safety of
Medical Electrical Equipment’ are applicable for
electrically powered equipment.
Not for use in areas of explosion hazard
This apparatus is neither approved nor certified for use in
areas where combustible or explosive gas mixtures are
likely to occur.
Safe connection with other electrical equipment
Electrical connections to equipment which is not listed in
these Instructions for Use shoutd oniy be made f&wing
consultations with the respective manufacturers or an
expert.
Liability for proper function or damage
The liabifky for the proper function of the apparatus is
irrevocably transferred to the owner or operator to the
extent that the apparatus is serviced or repaired by
personnel not employed or autftorired by DragerService
or if the apparatus is used in a manner not conforming to
its intended use.
Dragenverk Aktiengesellschaft cannot be held
responsible for damage caused by non-compliance with
the recommendations given above. The warranty and
liability provisions of the terms of sale and delivery of
Dragerwerk Aktiengesellschaft are likewise not modified
by the recommendations given above.
Dragerwerk Aktiengesellschaft 12.82
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44

Intended Use
Time-cycled, volumeconstant long-term ventilator for
intensive care. For adults and children with a body weigh1
of at least 3 kg.
With the following ventilation modes:
IPPV
SIMV
MMV
SB
CPAP
ASB
BIPAP
BIPAP-SIMV
BIPAP-APRV
Intermittent Positive Pressure Ventilation
controlled and assisted volume-constant
ventilation.
With the options:
- CPPV (Continuous Positive Pressure
Ventilation)
- PLV (Pressure Limited Ventilation)
- PCV (Pressure Controlled Ventilation]
- IRV (Inverse Ratio Ventilation).
Synchronised Intermittent Mandatory
Ventilation,
procedure for weaning spontaneously-
breathing patients off the ventilator.
Mandatory Minute Volume Ventilation,
spontaneous breathing with automatic
adjustment of mandatory ventilation to
the patient’s minute volume
requirement.
Spontaneous Breathing,
spontaneous breathing at ambient
pressure.
Spontaneous breathing with positive
airway pressure.
Assisted Spontaneous Breathing,
pressure-assisted spontaneous
breathing.
Biphasic Positive Airway Pressure,
spontaneous breathing on two different
CPAP levels and adjustable pressure
increase with switching between CPAP
levels automatically synchronised.
Spontaneous breathing on two pressure
levels (same as BIPAP), but with SIMV
time model and pressure assistance
ASB
Airway Pressure Release Ventilation,
spontaneous breathing on two pressure
levels (same as BIPAP) with long time
ranges, independently adjustable.
Special types:
Apnoea-
ventilation
ILV (optional)
Diagnosis:
Tachypnoea
Intrinsic
PEEP
measurement
Occlision
pressure
Spontaneous breathing with guaranteed
ventilation after end of adjustable
Apnoea time.
Independent Lung Ventilation
independent, differentiated, synchr
nised ventilation with two Evita 2
ventilators.
for detecting dead space intensive
spontaneous breathing.
for determining intrinsic PEEP during air
trapping.
for evaluating breathing drive during
spontaneous breathing.

intended Use
With monitoring for:
- airway pressure, Paw
- minute volume, VE
- inspiratory 02 concentration, FiOz
- inspiratory breathing gas temperature
Automatic switch-over of gas. In the event of a gas failure, the change over to
another gas is automatic.
Tbii equipment must not be used with flammable gases or anaesthetic
agents. Danger of fire.

Monitoring Ventilation
Appropriate monitoring of ventilation
(recommendations by DGAI)
The following ventilation parameters are monitored to
ensure appropriate supervision of ventilation and the
detection of undesirable changes:
- airway pressure
- inspiratoiy oxygen concentration
- expiratory minute volume
- inspiratory breathing gas temperature, where
applicable.
Changes in these parameters may be caused by:
acute changes in the patient’s condition
incorrect settings and faulty handling
malfunctioning equipment
failure of power and gas supplies
Evita 2 has built-in monitoring facilities for airway
pressure, inspiratory oxygen concentration, expiratory
minute volume, as well as inspiratory breathing gas
temperature.
If a fault occurs in the equipment, separate measuring
instruments (e.g. PM 8030, Oxydig. AWT 01) may be
used.
Ventilation with an independent manual ventilatidn
device
When due to a recognised fault in the ventilator its life-
support functions can no longer be ensured, ventilation
must be started without delay by means of an
independent ventilation device - if required with PEEP
and/or increased inspiratory 02 concentration (e.g.
Resutator 2000).
6

Preparation
The following description refers to the assembly of the
equipment. the connection of the hoses, as welt as the
calibration of the integrated monitors. These actions must
be followed by a test of readiness for operation, page 92.
Fitting patient system
. Push patient system into mounting as far as it will go.
Make sure that it is engaged by gently pulling the port.
Fitting flow sensor
1 Push socket to the left as far as it will go.
Place flow sensor - with plug towards the equipmeit
-into the mounting and push into the socket as far as
it will go.
Then:
push to the right into the rubber lip on the patient
system as far as it will go.

Preparation
Fitting 02 sensor
- when operating for the first time
- when display reads:
01 meas. hop
when calibration can no longer be carried out.
1 Turn port downwards or to the left.
2 Use coin to loosen screw, remove protective cover.
3 Remove 02 sensor from the mounting and unscrew
housing.
Insert new sensor capsule:
l The side with circular contacts goes into the housing
l Re-assemble sensor housing, push firmly into the
mounting. Re-assemble protective cover.
l Dispose of used sensor, page 102.

Preparation
For Ventilating Adults and Children
from 100 mL tidal volume VT
DO not use a humidiiir at the same time as a heat
and moisture exchanger.
Risk of increased breathing resistance because of
condensation.
Connecting Aquapor humidifier
Prepare Aquapor following relevant Instructions for Use.
1 Hang Aquapor from rail by bracket and tighten
screws.
2 Insert elbow connector into Aquapor.
3 Insert connector into elbow connector.
l Fill Aquapor bowl with distilled water to upper mark.
Connecting ventilation hoses
Do not use antistaiic or conductive hoses’.
The ventilation hoses can be attached on either side of
the machine.
Attachment on left-hand side:
4 Rotate both p$ to the left by 180’.
5 Swivel Aquapor to the left.
The following description applies when ventilation hoses
have been attached on left-hand side.

Preparation
Suspend hinged arm from rail on left-hand side and
tighten screws.
Connect ventilation hoses, note length of hose
(metres).
Rotate ports in the direction of the hoses.
Keep water traps in a vertical position.
Fitting temperature sensor
4 Put sensor into rubber sleeve on inspiratory side of Y-
piece. Align Y-piece so that sensbr is located at the
top.
5 Attach sensor cable with hose clips.
6 Insert cable plug into socket at rear.
Evita 2 can also be operated without a temperature
sensor, if the temperature sensor was not connected
when switching on.
10

-I
Preparation
For Ventilating Infants
Up to 300 mL tidal volume VT
Do not use a humidifier at the same time as a heat
and moisture exchanger.
Risk of increased breathing resistance bequse of
condensation.
Prepare ‘Fisher & Paykel MR 730’ humidifier
following Instructions for Use, using K. F & P hose
set.
Attach humidifier and bracket to mounting below the
equipment and tighten screws.
Hang hinged arm from rail by bracket on left-hand
side and tighten screws.
Connect ventilation hoses, note length of hoses
(metres).
Keep water trap in a vertical position.
i

Preparation
Electrical power supply
Mains voltage must correspond to voltage range given on
plate on back.
either: 220vto24ov
or : 1M)V to 127 V
l Insert mains connector.
Socket strip for ancillary equipment
Connecting equipment to extension sockets may lead to
an increase iri current leakage to the patient beyond the
permissible values in the event of earth failure. There may
then be an increased electrical risk.
Connection to other equipment
- via optional RS 232 interface.
Connecting electronics to earth:
l Slide switch (back of machine) upwards
l Do not earth the electronics of the other equipment
connected to Evita 2.
When no equipment connected to Evita 2
l Slide switch downwards.
12
A 43

Preparation
Operating for the first time
Charging storage battery for mains failure
alarm
The built-in battery for power failures is automatically re
charged during operation. Before operating for the first
time the equipment should be run for 2 hours to make
sure that the battery is adequately charged.
1 Push in mains switch on left hand side at the back
until stop = ON.
Display on screen:
ilciger
Evita 2
A self-test which checks the internal programme memory
runs for about 10 seconds. All LEDs are lit. The
measured value display shows which software version is
being used:
. Display on screen (example):
After swathing on, Evita 2 always starts ventilation in the
ventilation procedure and patient mode selected
previously.
,
14 ,
i

When another patient mode is selected:
. In lpatients* menu, select between adults and I
children:
withm button or Q button.
The selection is shown light on a dark background.
l Confirm selection:
with a button.
Display on screen (example):
Preparation
Keep cl
‘=w button pressed for about 3 seconds, until
green LED is continuously lit.
Rotary knob -VT- to 0.5 L.
Other rotary knobs to *green dot-.
To switch off alarm limits for minute volume VE:
3 Press ? button until upper alarm limit/L = OFF.
0
4 Press q button until lower alarm limit I/= OFF.
. Attach 2.0 L breathing bag on Y-piece, and operate
Evita 2 for about 2 hours at this setting to re-charge
storage battery for mains failure alarm completely.

Preparation
To switch off equipment -
At rear:
5 Move protective cap on mains power plug aside,
6 Push button in as far es it will go and release = OFF. z
I 16

Calibration
The values obtained during the last calibration will be
stored until the next calibration, even when the machine is
switched off. Flow sensor can be calibrated at any time,
including during ventilation. The pressure sensors are
calibrated automatically for measuring airway pressure.
Calibrating 02 sensor
- When 02 alarm has been given.
- Following sensor replacement
- When the difference between measured value and
set value has been more than 2 vol.%
We recommend calibration every time the machine is
prepared for optimum accuracy of measurement. The 02
sensor can be calibrated with 100 vol.% 01 at any time,
provided that the ventilation hose system is disconnected
during calibration.
-
Keep v
lzl button pressed for at least 3 seconds,
until the yellow LED remains continuously lit.
Display for 02 concentration in window:
Display on screen:
disconnect Y-piece
Evita 2 now ventilates with 100 vol.% Oz. If no PEEP
greater than 4 mbar has been set, a PEEP of 4 mbar
comes into operation. With this PEEP, Evita 2 can detect
any disconnection of the Y-piece which may follow.
. Disconnect the Y-piece within the next minute.
The machine detects the disconnection.
3 Display on screen:
01 calibration’

Preparation
During calibration the acoustic alarms are suppressed.
When calibration has finished, the machine restarts
ventilation.
l Reconnect Y-piece.
The acoustic alarms remain muted for another
15 minutes, the lower alarm limit for minute volume is
switched off for 2 minutes.
1 Screen display:
02 Cal. interrupted
Or
2 Display in window for 02 concentration:
_-
See ‘Fault, Cause, Remedy’, page 104.
If calibration is to be discontinued for instance,
when &ta needs to be used immediately:
3 Press w
v button again, the machine operates with
the previous calibration values and
1 Display on screen:
02 Cal. interrupted
When monitoring is to be switched off in exceptional
circumstances
for instance, if a malfunction in 02 measurement cannot
be put right immediately:
4 Press I!3 button, yellow LED flashes:
Ch monitoring is switched off permanently
Switching on again:
4 Press @ button again, yellow LED goes out.
L
15 :

Preparation
Calibrating flow sensor
- Every 24 hours
- Following sensor replacement.
Before each calibration the flow sensor is cleaned
automatically. After a medicament nebulizer has been
used the flow sensor is cleaned automatically and
calibrated.
Calibration is carried out automatically during the
inspiration phase.
1 Press @ button:
At the start of inspiration the expiratory valve is closed
for about 1 second: flow = 0. Shorter inspiration times
are increased to about 1 second. Yellow LED lights
during calibration.
2 Display on screen:
flow Cal.’
_
After calibration the yellow LED in Q button goes out.
I3
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‘Q I,
86 ’

Preparation
Equipment Check
- immediately before use.
A copy of the following checklist is in the drawer below the machine.
. Each step of the checklist must be ticked off with a pencil, dated and signed by the checker.
System I Whet I Requirement
Breathing system
flectrical suppiy
Patient system
Flow sensor
Temperature sensor
Hoses, water traps, humidifier
Mains switch ON,
Connect mains plug:
Press qbutton:
engaged or screwed on.
connected.
inserted.
complete and fixed.
Intermittent sound commences.
Cantinuws sound, and then intermittent sound
Display: air supply down
Fan noise and suction at the fan in the back of
the machine.
;as supply Insert .Oz. and .air. probes New display:
airway pressure low
iunidiier Aquapor’
Electrical supply
fu”ction
3alibration
Flow
02
K=P @ button pressed:
Distilled water level:
Mains switch ON,
Heating switched on
Press button o
I3
Only if measured value deviates from set
value by more than 2 vol.%:
Continuous sound commences. all number
displays are shown and all LEDs are lit.
to .“lax.
white -Mains. light on
yellow #eating. light on.
Display: flow CBI.
Press button v and leave Y-piece open.
Cl Display: 01 cal.
&s-tightness of breathing Rotay knob VT to 0.1 L or for When peak pressure of 80 mbar is reached,
;ystCl”l paed. ventilation to 0.04 L. plateau pressure must not be below peak
*insp. flow Vrnnw to 6 Llmin qj.
pressure by more than 15 mbar.
.pmu. to 80 mbar and press button If peak pressure remains below 60 mbar,
plateau pressure must not be below peak
*TI:TE. to 4: 1 and press q button, pressure by more then 10 mbar.
all other rotary knobs to .gree” dote A slight pressure increase (caused by internal
Keep Y-piece sealed and observe peak flush flow) indicates suficient tightness).
pressure (pmax) and plateau pressure (pplat)
over several ventilation strokes.
TV function -VT. to 0.1 L. or for paed. ventilatio” to 0.04 L, After about 30 s in the right-hand display:
*pmu* to 60 mbar, all other rotary knobs
to .green dot..
Con”FJct test lung 64 03 201. Tidal volume VT~ 80 to 100 mL
Or: frequency f 12 * llmin
Connect child test lung 64 Og 742. or for paed. ventilation 36 to 44 mL.
SBlspont. function Press button IzJ ’CPAP to 5 mbar,
.AS5 to 20 mbar
.A.too.5,
Squeeze test lung or child test lung on
Y- piece gently and release.
Airway pressure rises to aboui 20 mbar
and then falls back to 5 mbar.