Dräger Evita V Series User manual

Evita V series / Babylog VN series
Reprocessing instructions
WARNING
To properly reprocess the products, read and comply
with this document.
Evita V series / Babylog VN series

2 Reprocessing instructions | Evita V series / Babylog VN series
Contents
Evita V series / Babylog VN series
Contents
1Information about this document ........................................................... 3
1.1 Scope of application ....................................................................... 3
1.2 Typographical conventions ............................................................. 3
1.3 Illustrations...................................................................................... 3
1.4 Use of terms ................................................................................... 3
1.5 Trademarks..................................................................................... 4
1.5.1 Trademarks owned by Dräger .......................................... 4
1.5.2 Trademarks owned by third-party manufacturers............. 4
2Safety-related information....................................................................... 5
2.1 Information on safety instructions and precautionary statements... 5
2.1.1 Safety instructions ............................................................ 5
2.1.2 Precautionary statements................................................. 5
2.2 Safety instructions .......................................................................... 5
2.2.1 Flow sensors .................................................................... 6
2.2.2 Inspiratory valve ............................................................... 7
3Reprocessing............................................................................................ 8
3.1 Information on reprocessing ........................................................... 8
3.2 Classifications for reprocessing ...................................................... 8
3.2.1 Classification of medical devices...................................... 8
3.2.2 Classification of device-specific components ................... 8
3.3 Before reprocessing........................................................................ 9
3.3.1 Patient-specific accessories and consumables ................ 9
3.3.2 Device-specific components............................................. 12
3.4 Validated reprocessing procedures ................................................ 15
3.4.1 Overview of the reprocessing procedures for the device
and device-specific components ...................................... 15
3.4.2 Surface disinfection with cleaning .................................... 15
3.4.3 Machine cleaning with thermal disinfection ...................... 16
3.4.4 Storage and transport....................................................... 19
3.5 Other agents and reprocessing procedures ................................... 19
3.5.1 Disinfectants ..................................................................... 19
3.5.2 Reprocessing procedures................................................. 20
3.6 Reprocessing of patient-specific accessories................................. 21
3.6.1 Categorization of accessories .......................................... 21
3.6.2 Validated reprocessing of the CO2sensor ....................... 22
3.6.3 Validated reprocessing of the reusable cuvette for the CO2
sensor............................................................................... 23
3.6.4 Validated reprocessing of the expiratory flow sensor....... 24
3.6.5 Validated reprocessing of the neonatal flow sensor......... 25
3.6.6 Storage and transport....................................................... 28
3.6.7 Other agents and reprocessing procedures ..................... 28
3.7 After reprocessing........................................................................... 31
3.7.1 Assembling and fitting device-specific components ......... 31
3.7.2 Preparation before next use of device.............................. 34

Reprocessing instructions | Evita V series / Babylog VN series 3
Information about this document
1 Information about this document
1.1 Scope of application
These reprocessing instructions apply to all ventilators in the Evita V series and in
the Babylog VN series.
These reprocessing instructions replace the "Reprocessing" chapter in the
instructions for use for the ventilators Evita Infinity V500, Evita V300, and
Babylog VN500.
1.2 Typographical conventions
1.3 Illustrations
Illustrations of products and screen content in this document may differ from the
actual products depending on configuration and design.
1.4 Use of terms
Dräger uses the term "accessories" not only for accessories in the sense of
IEC 60601-1, but also for consumables, removable parts, and attached parts.
Ventilators in the Evita V series are also referred to as "Evita".
Ventilators in the Babylog VN series are also referred to as "Babylog".
Text Bold, italicized texts indicate labels on the device and screen texts.
1. Numbers followed by a period indicate individual action steps in a
sequence of actions. Numbering begins with the number 1 for each new
sequence of actions.
a. Lowercase letters followed by a period indicate subordinate action steps.
Numbering begins anew with the letter a. for each new subordinate action
step.
●This bullet point indicates individual process steps with no specific
sequence.
►This triangle in safety instructions and precautionary statements indicates
ways to avoid danger.
(1) Numbers in parentheses refer to elements in figures.
1Numbers in figures indicate elements referred to in the text.
– Dashes indicate listings.
> The greater-than symbol indicates the navigation path in a dialog.
This symbol indicates information that makes it easier to use the product.
This arrow indicates the result of an action step.
✓This check mark indicates the result of a sequence of actions.

4 Reprocessing instructions | Evita V series / Babylog VN series
Information about this document
1.5 Trademarks
1.5.1 Trademarks owned by Dräger
The following web page provides a list of the countries in which the trademarks are
registered: www.draeger.com/trademarks
1.5.2 Trademarks owned by third-party manufacturers
Trademark
Evita®
Babylog®
Infinity®
Trademark Trademark owner
Dismozon®
BODE Chemie
Korsolex®
neodisher mediclean®Dr. Weigert
acryl-des®
Schülke & Mayr
Gigasept®
Mikrozid®
Perform®
Actichlor®
Ecolab USA
Incidin®
Oxycide®
Sekusept®
BruTab 6S®Brulin
Dispatch®Clorox
Klorsept®Medentech
Descogen®
Antiseptica
Oxygenon®
SteriMax®Aseptix
Cleanisept®Dr. Schumacher
CIDEX®Johnson & Johnson

Reprocessing instructions | Evita V series / Babylog VN series 5
Safety-related information
2 Safety-related information
2.1 Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
2.1.1 Safety instructions
This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
2.1.2 Precautionary statements
Precautionary statements relate to action steps and warn of risks that may arise
when performing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.
2.2 Safety instructions
Reusable products
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
►Follow the infection prevention policies and reprocessing regulations of the
health-care facility.
►Follow the national infection prevention policies and reprocessing regulations.
►Use validated procedures for reprocessing.
►Follow the manufacturer's instructions for cleaning agents, disinfectants, and
reprocessing devices.
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with
reprocessed products.
►Check products for signs of wear and replace them if necessary.
Warning sign Signal word Consequences of non-compliance
WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

6 Reprocessing instructions | Evita V series / Babylog VN series
Safety-related information
2.2.1 Flow sensors
Flammable substances
The flow sensor may ignite medications or other substances based on easily
flammable substances. The patient may be put at risk.
►Do not nebulize medications or other substances that are easily flammable or
spray them into the device.
►Do not use substances containing alcohol.
►Do not allow combustible or explosive substances to enter the breathing system
or the breathing circuit.
Residual vapors of highly flammable disinfectants
Residual vapors of highly flammable disinfectants (e.g., alcohols) and deposits that
were not removed during reprocessing may ignite when the flow sensor is in use.
The patient may be put at risk.
►Ensure particle-free cleaning and disinfection.
►After disinfection, allow the flow sensor to air-dry for at least 30 minutes.
►Before inserting, check the flow sensor for visible damage and soiling, such as
residual mucus, medication aerosols, and particles.
►Replace flow sensors when damaged, soiled, or not particle-free.
Expiratory flow sensor
Improper reprocessing and soiling, such as deposits or particles, may damage the
flow sensor. The flow measurement may fail. As a result, the patient may be put at
risk.
►No machine cleaning or disinfection
►No plasma sterilization or radiation sterilization
►No water jets, compressed air, brushes or the like
►No ultrasonic bath
►No hot steam sterilization of the Spirolog flow sensor
►Clean and disinfect the flow sensor in accordance with the reprocessing
instructions.
►For disinfecting the flow sensor use only clean disinfectant solutions.
Neonatal flow sensor
Improper reprocessing and soiling, such as deposits or particles, may damage the
flow sensor. The flow measurement may fail. As a result, the patient may be put at
risk.
►No machine cleaning or disinfection of the sensor insert
►No plasma sterilization or radiation sterilization
►No water jets, compressed air, brushes or the like when cleaning the sensor
insert
►No ultrasonic bath
►Clean and disinfect the flow sensor in accordance with the reprocessing
instructions.
►For disinfecting the flow sensor use only clean disinfectant solutions.

Reprocessing instructions | Evita V series / Babylog VN series 7
Safety-related information
2.2.2 Inspiratory valve
For spontaneously breathing patients, patient gas can flow through the inspiratory
valve in the following situations:
– Overpressure in the system caused by a kink in the expiratory hose
– Failure of both supply gases
– Complete failure of the power supply (failure of mains power supply and
discharged or faulty batteries)
If the inspiratory valve is not reprocessed after situations like these, there is a risk of
infection.
►Reprocess the inspiratory valve.

8 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
3 Reprocessing
3.1 Information on reprocessing
Follow the national infection prevention policies and reprocessing regulations.
Follow the infection prevention policies and reprocessing regulations of the health-
care facility (e.g., concerning the reprocessing cycles).
Reusable components through which contaminated breathing gas passes during
normal operation and in the event of a fault must be reprocessed. In normal
operation, contaminated breathing gas passes through the expiratory valve and
other accessories in the expiratory path. In the event of a fault, the inspiratory valve
and other accessories in the inspiratory path may become contaminated.
3.2 Classifications for reprocessing
3.2.1 Classification of medical devices
The classification depends on the intended use of the medical device. The risk of
infection transmission through the application of the product to the patient without
proper reprocessing is the basis of the Spaulding classification.
3.2.2 Classification of device-specific components
The following classification is a recommendation from Dräger.
Non-critical
– Device surface, incl. display unit
– Trolley and holders
– GS500 gas supply unit
– PS500 power supply unit
– Removable parts of the main device
Semi-critical
– Inspiratory valve
– Expiratory valve
– Neonatal expiratory valve
Classification Explanation
Non-critical Components that come into contact only with skin that is
intact
Semi-critical Components that carry breathing gas or come into contact
with mucous membranes or pathologically altered skin
Critical Components that penetrate skin or mucous membranes or
come into contact with blood

Reprocessing instructions | Evita V series / Babylog VN series 9
Reprocessing
3.3 Before reprocessing
Observe before disassembly
1. Switch off the device and all devices connected to it.
2. Disconnect all power plugs.
3. Drain the water traps and the breathing hoses.
4. Drain the water reservoir of the breathing gas humidifier.
3.3.1 Patient-specific accessories and consumables
The patient-specific accessories and consumables must be removed from the
device and, if necessary, disassembled.
Reusable products:
●Perform reprocessing in accordance with the instructions in these instructions
for use. If the reusable product has its own instructions for use, perform
reprocessing in accordance with the most recent document. In addition, note the
edition on the back of the documents.
Disposable products:
●Dispose of the disposable products.
Removing the breathing circuit
●Remove the breathing hoses from the inspiratory port and the expiratory port.
Removing the expiratory flow sensor from the ventilator Evita
1. Open the flap.
2. Push the flow sensor as far as possible to the left.
3. Remove the flow sensor (1) from the socket (2).
39449
2
2
1

10 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
Disassembling the neonatal flow sensor
Prerequisites:
– The sensor plug was removed from the rear of the device.
Procedure for the ISO 15 neonatal flow sensor:
1. Remove the flow sensor housing (4) from the Y-piece.
2. Disconnect the plug of the flow sensor cable (1) from the flow sensor.
3. Gently press the knobs (2) on both sides while removing the insert (3) from the
sensor housing (4).
Procedure for the neonatal flow sensor Y-piece:
1. Remove the breathing hoses from the flow sensor Y-piece (4).
2. Disconnect the plug of the flow sensor cable (1) from the flow sensor.
3. Gently press the knobs (2) on both sides while removing the sensor insert (3)
from the flow sensor Y-piece (4).
Removing the CO2sensor
Prerequisites:
– The sensor plug was removed from the rear of the device.
Procedure:
1. Remove the CO2sensor (1) from the cuvette.
2. Remove the cuvette (2) from the patient port of the Y-piece.
394313943339435
13 2
4
1
2
3
4
2
1

Reprocessing instructions | Evita V series / Babylog VN series 11
Reprocessing
Removing the pneumatic medication nebulizer (white, 8412935)
After use in the Adult patient category:
1. Remove the nebulizer hose (1) from the medication nebulizer (2) and from the
nebulizer port on the device.
2. Remove the medication nebulizer (2) from the breathing hoses.
3. Disassemble the medication nebulizer in accordance with the corresponding
instructions for use.
After use in the Pediatric patient and Neonate patient categories:
1. Remove the nebulizer hose (7) from the medication nebulizer (5) and from the
nebulizer port on the device.
2. Remove the medication nebulizer (5) from the breathing hoses.
3. Remove the soft connector (6) from the inlet port.
4. Remove the adapter (4) from the outlet port.
5. Remove the corrugated hose (3) from the adapter (4).
6. Disassemble the medication nebulizer in accordance with the corresponding
instructions for use.
Removing the pneumatic medication nebulizer (black, 8411030)
1. Remove the nebulizer hose (1) from the medication nebulizer (2) and from the
nebulizer port on the device.
2. Remove the medication nebulizer (2) from the breathing hoses.
3. Remove the corrugated hose for the breathing circuit (3) from the inlet port.
4. Remove the corrugated hose (4) from the outlet port.
394393943840334
2
1
45 6
7
3
3
1
2
4

12 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
5. Disassemble the medication nebulizer in accordance with the corresponding
instructions for use.
3.3.2 Device-specific components
The device-specific components must be removed from the device and, if
necessary, disassembled.
Removing the expiratory valve or the neonatal expiratory valve from the
ventilator
This section addresses how to remove the expiratory valve from the ventilator Evita.
The neonatal expiratory valve is removed from the Evita and Babylog ventilators in
the same manner.
Prerequisites:
– The flap on the front of the ventilator is open.
– The expiratory flow sensor is removed from the ventilator Evita.
Procedure:
1. Turn the locking ring (1) as far as possible to the left.
2. Remove the expiratory valve from the fitting.
39425
1
1

Reprocessing instructions | Evita V series / Babylog VN series 13
Reprocessing
Disassembling the expiratory valve or the neonatal expiratory valve
Procedure:
1. Remove the flow sensor sleeve (1) from the expiratory valve or remove the
muffler (3) from the neonatal expiratory valve.
2. Remove the diaphragm (2) and do not disassemble it further.
3. Remove the water trap container (4).
4. Drain the water trap container.
Removing the inspiratory valve from the ventilator
This section addresses how to remove the inspiratory valve from the ventilator
Evita. The neonatal inspiratory valve is removed from the ventilator Babylog in the
same manner.
Prerequisites:
– The inspiratory valve is removed and disassembled only if patient gas has
flowed through the inspiratory valve.
– The device is switched off.
44584
No. Expiratory valve Neonatal expiratory valve
1 Flow sensor sleeve -
2 Diaphragm Diaphragm
3- Muffler
4 Water trap container Water trap container
21
4
2
3
4

14 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
Procedure:
1. Press and hold the locking lever (2) on the underside of the inspiratory valve (1).
2. Simultaneously turn the inspiratory valve approx. 20° counterclockwise.
3. Remove the inspiratory valve from the fitting.
Disassembling the inspiratory valve
This section addresses how to disassemble the inspiratory valve for the ventilator
Evita. The neonatal inspiratory valve is disassembled from the ventilator Babylog in
the same manner.
1. Remove the diaphragm with adapter (1) from the fitting of the inspiratory valve.
2. Remove the seal (2).
3943639437
1
2
1 2

Reprocessing instructions | Evita V series / Babylog VN series 15
Reprocessing
3.4 Validated reprocessing procedures
3.4.1 Overview of the reprocessing procedures for the device and
device-specific components
3.4.2 Surface disinfection with cleaning
Components:
– Device surface, trolley, and additional non-critical components
Prerequisites:
– The surface disinfectant has been prepared in accordance with the
manufacturer's instructions.
– The manufacturer's instructions, e.g., regarding shelf life or application
conditions, are observed.
– An uncontaminated, lint-free cloth soaked in surface disinfectant is used for the
cleaning surface disinfection.
WARNING
Risk due to penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
►Ensure that no liquid penetrates the device.
Cleaning
1. Wipe off obvious soiling with a disposable cloth soaked in surface disinfectant.
Dispose of the cloth.
2. Wipe all surfaces. After that, there must no longer be any soiling visible.
Surface disinfection
3. Wipe cleaned surfaces again to visibly wet all surfaces to be disinfected with
surface disinfectant.
4. Wait for the surface disinfectant contact time.
Device and components Surface disinfection
with cleaning
Machine cleaning with
thermal disinfection
Device surface, trolley,
and additional non-critical
components
Yes (see "Surface disin-
fection with cleaning",
page 15)
No
Expiratory valve No Yes (see "Machine clean-
ing with thermal disinfec-
tion", page 16)
Neonatal expiratory valve
Inspiratory valve
Surface disinfec-
tant
Manufacturer Concentration Contact time
Oxycide Ecolab USA 2.3 % 5 min
Dismozon pur/plus BODE Chemie 1.6 % 15 min

16 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
5. At the end of the contact time, moisten a new, uncontaminated and lint-free cloth
with water (at least drinking water quality).
6. Wipe all surfaces until no remains of the surface disinfectant, such as foam
residues or streaks, are visible.
7. Wait until the surfaces are dry.
8. Check the surfaces for visible damage and, if necessary, replace the product.
3.4.3 Machine cleaning with thermal disinfection
Use a washer-disinfector that meets the requirements of the standard ISO 15883.
Dräger recommends the use of a load carrier for anesthesia accessories and
ventilation accessories. Follow the manufacturer's instructions for the washer-
disinfector.
Components:
– Expiratory valve
– Neonatal expiratory valve
– Inspiratory valve
Prerequisites:
– The washer-disinfector has been prepared in accordance with the
manufacturer's instructions.
Step Agent Manufac-
turer
Concentra-
tion
Temperature Contact time
Preliminary clean-
ing
Tap water – – Tap water tem-
perature
Min. 2 min
Cleaning neodisher medi-
clean forte
Dr. Weigert Min. 0.3 % Min. 55 °C
(131 °F)
Min. 5 min
Neutralizing neodisher Z Dr. Weigert Min. 0.1 % Tap water tem-
perature
Min. 1 min
Flushing Demineralized
water
– – Tap water tem-
perature
Min. 1 min
Disinfecting – – – Min. 90 °C
(194 °F)
Min. 5 min
Drying – – – – Drying time
depends on the
load

Reprocessing instructions | Evita V series / Babylog VN series 17
Reprocessing
Positioning the expiratory valve in the load carrier
Procedure:
1. Position the expiratory valve as shown.
2. Position the components (flow sensor sleeve, diaphragm, water trap container)
to be stable.
3. Ensure the following:
– All surfaces and interior spaces can be completely rinsed.
– The water can drain off freely.
Positioning the neonatal expiratory valve in the load carrier
Required aids:
– Hose (diameter: 12 mm (0.47 in), length: max. 50 cm (19.7 in)) to connect the
neonatal expiratory valve
Procedure:
1. Connect the hose to the nozzle of the neonatal expiratory valve.
2. Connect the other end of the hose to a suitable nozzle on the load carrier.
3. Position the components (muffler, diaphragm, water trap container) to be stable.
4143640310

18 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
4. Ensure the following:
– All surfaces and interior spaces can be completely rinsed.
– The water can drain off freely.
Positioning the inspiratory valve in the load carrier
The following section addresses the inspiratory valve for the ventilator Evita. The
inspiratory valve for the ventilator Babylog is positioned in the same manner.
Procedure:
1. Position the inspiratory valve as shown.
Example: Inspiratory valve for Evita:
2. Position the components (diaphragm with adapter, seal) to be stable.
3. Ensure the following:
– All surfaces and interior spaces can be completely rinsed.
– The water can drain off freely.
Performing reprocessing
1. Select a cycle.
2. When the cycle has ended, check the components for visible soiling and repeat
the cycle if necessary.
3. Check the components for visible damage and replace if necessary.
Supplementary information
Dräger states that nebulization and reprocessing may result in color changes in
the metal insert. Color change does not indicate that the product is not functioning
correctly.
Flow sensor sleeve:
The life span of plastics is limited and depends on the way in which they are
reprocessed and how frequently. If the surface is cracked, sticky, or strongly
discolored or if the material has hardened, the function of the components must be
checked and the component replaced, if necessary.
41435

Reprocessing instructions | Evita V series / Babylog VN series 19
Reprocessing
3.4.4 Storage and transport
After reprocessing, there are no special requirements for storage and transport of
the product. However, the following must be observed:
– Store dry and free of dust
– Avoid recontamination and damage during transport
All further information on storage and transport included in the accompanying
documents must be observed.
3.5 Other agents and reprocessing procedures
3.5.1 Disinfectants
Use nationally approved disinfectants suitable for the respective reprocessing
process and the intended application.
Surface disinfectants
The manufacturers of the surface disinfectants have verified at least the following
spectra of activity:
– Bactericidal
– Yeasticidal
– Virucidal or virucidal against enveloped viruses
Follow the manufacturer's instructions for surface disinfectants.
The following surface disinfectants were compatible with the material at the time of
testing:
Class of active
ingredient
Surface disinfectant Manufacturer Listing
Chlorine-releas-
ing agents
BruTab 6S Brulin EPA1)
Clorox Professional Disinfect-
ing Bleach Cleaner
Clorox EPA
Dispatch Hospital Cleaner
Disinfectant Towels with
Bleach
Klorsept 17 Medentech EPA
Actichlor plus Ecolab USA EPA
Oxygen-releas-
ing agents
Descogen Liquid Antiseptica CE
Descogen Liquid r.f.u.
Oxygenon Liquid r.f.u.
Dismozon plus BODE Chemie CE
Oxycide Ecolab USA EPA
Perform Schülke &
Mayr
CE
SteriMax Wipes Aseptix CE
Incidin OxyWipes Ecolab USA CE

20 Reprocessing instructions | Evita V series / Babylog VN series
Reprocessing
Dräger states that oxygen-releasing agents and chlorine-releasing agents may
cause color change in some materials. Color change does not indicate that the
product is not functioning correctly.
Other surface disinfectants are used at one's own risk.
3.5.2 Reprocessing procedures
3.5.2.1 Manual cleaning followed by disinfection by immersion
Manual cleaning with subsequent disinfection by immersion can be performed for
the following components:
– Expiratory valve
– Neonatal expiratory valve
– Inspiratory valve
The following disinfectants were compatible with the material at the time of testing:
Quaternary
ammonium com-
pounds
acryl-des2) Schülke &
Mayr
CE
Mikrozid alcohol free liquid2)
Mikrozid alcohol free wipes2)
Mikrozid sensitive liquid2)
Mikrozid sensitive wipes2)
Cleanisept Wipes Maxi Dr. Schum-
acher
CE
Surfa'Safe Premium ANIOS Labo-
ratories
CE
Wip'Anios Excel
Tuffie 5 Vernacare ARTG3)
1) United States Environmental Protection Agency
2) Virucidal against enveloped viruses
3) Australian Register of Therapeutic Goods
Class of active
ingredient
Surface disinfectant Manufacturer Listing
Component Agent Manufacturer
Inspiratory valve, expira-
tory valve
Cleaning agent:
neodisher LM2 Dr. Weigert
Disinfectant:
Korsolex Extra BODE Chemie
Neonatal expiratory valve Cleaning agent:
Sekusept Pulver CLASSIC Ecolab
Disinfectant:
Korsolex Extra BODE Chemie