Getinge servoair_operman_6882040_r03_v2dot1_170223-en-non_us n Ventilator Systems Cleaning and Maintenance User's Manual
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User's Manual
SERVO-air Ventilator System
Cleaning and Maintenance
Table of contents
| Table of contents |
1
2
3
4
5
6
7
8
4|Introduction
7|Patient unit and user interface
11|Expiratory cassette
15|O2 cell (maintenance)
17|Inspiratory channel (maintenance)
20|Aerogen Pro nebulizer
23|Accessories
24|Recommended intervals and disinfectants
SERVO-airVentilator System, User's Manual
Infologic 1.18
3
| Introduction |
| 1
1 Introduction Table of contents
5|Introduction1.1
5|General information1.2
5|Safety guidelines1.3
6|Symbols1.4
4
SERVO-airVentilator System, User's Manual
| Introduction |
1 |
1.1 Introduction
Unless otherwise stated, the information in
this User's Manual is valid for the SERVO-air
ventilator system.
Here you will find the information needed to
safely clean and maintain the ventilator
system.
1.2 General information
As cleaning practices vary widely among
health care institutions, it is not possible for
Maquet to specify particular practices that will
meet all needs, or to be responsible for the
effectiveness of cleaning procedures carried
out in the patient care setting.
Maquet recommends methods that have been
validated using the specified equipment and
procedures outlined in this manual. Other
methods may work but are not covered by the
warranty unless Maquet has given written
permission.
1.3 Safety guidelines
WARNING! Indicates critical information
about a potential serious outcome to the
patient or the user.
CAUTION: Indicates instructions that must
be followed in order to ensure the proper
operation of the equipment.
Important: Indicates information intended
to help you operate the equipment or its
connected devices easily and conveniently.
Note: Indicates information requiring special
attention.
CAUTIONS:
• All personnel should be aware of the risk
of parts being infected when
disassembling and cleaning the ventilator
system.
• The expiratory channel and expired gas
from the exhaust port may be
contaminated.
• All disposable parts must be discarded
according to hospital routines and in an
environmentally safe way.
SERVO-airVentilator System, User's Manual
5
| Introduction |
| 1
Important:
• Follow your hospital's routines for
handling infectious material when
handling any part of the ventilator
system.
• If possible, cleaning should be performed
immediately after use and always before
steam autoclaving/disinfection. Blood or
other residues should not be allowed to
dry onto the devices.
• Water quality affects
cleaning/disinfection. Maquet
recommends drinking water quality as
the minimum quality level.
• Maquet recommends the use of Servo
Duo Guard bacterial filter or equivalent
to reduce the transmission of bacteria
from the patient via the expiratory
cassette to the ambient air. This reduces
the risk of infection spread and prolongs
the life of the expiratory cassette due to
reduced cleaning requirements.
• The use of a washer-disinfector for
cleaning/disinfection is recommended if
bacterial filters are not used.
• Steam autoclaving is normally not
necessary for the expiratory cassette, as
it is not an invasive instrument, but when
applied, use processes recommended
by Maquet.
Notes:
• Single use (i.e. disposable) items shall
not be reused. Cleaning of single use
items can damage the item and
compromise its intended use. Reuse of
single use items increases the risk of
spreading infections and compromises
the durability of the item.
• Maquet recommends that the equipment
is inspected regularly.
• A preventive maintenance must be
performed by authorized personnel at
least once every year as long as the unit
is not used more than normal. Normal
operation during one year is estimated
to correspond to approximately 5000
hours of operation. The current operating
time and time to next preventive
maintenance is presented in SERVICE &
SETTINGS/BIOMED/STATUS/General
on the user interface.
1.4 Symbols
Hazardous wasteThe device
contains parts which must not be
disposed of with ordinary waste.
Special waste
This product contains electronic
and electrical components.
Discard disposable, replaced and
left-over parts in accordance with
appropriate industrial and
environmental standards.
6
SERVO-airVentilator System, User's Manual
2 Patient unit and user interface
| Patient unit and user interface |
2 |
2.1 Preparations
Note: Cleaning should be done after each
patient or according to hospital routines.
• Switch off the ventilator system using the
on/off switch on the patient unit.
• Disconnect the ventilator system from the
mains power and gas supply.
• Disconnect any optional equipment from
the mains power and from the ventilator
system.
• Discard disposable items according to
hospital routines and environmental
regulations.
- Servo Duo Guard viral/bacterial filter
- SERVO humidifier/HME
- disposable patient tubing
- disposable airway adapter
- Aerogen Solo nebulizer
• Remove the expiratory cassette.
2.1.1 Remove the expiratory cassette
Important: The expiratory cassette is a
precision instrument and must be handled
carefully.
• Tilt the user interface backwards.
• Press the button on the expiratory cassette.
• Tilt the cassette upwards and remove.
Important: After removing the expiratory
cassette, do not pour any fluid into the
expiratory cassette compartment. Avoid
contact with electrical connectors.
SERVO-airVentilator System, User's Manual
7
| Patient unit and user interface |
| 2
2.2 Wiping and discarding
Wipe all parts with cleaning wipes or a soft
lint-free cloth moistened in soap & water or
detergent-based disinfectant.
In case of more contaminated surfaces, use
ethyl alcohol (70%) or isopropyl alcohol (70%).
Avoid contact with electrical connectors.
Important: Do not use abrasive or sharp
tools to clean the user interface.
2.3 Assembling
2.3.1 Insert the expiratory cassette
• Hinge a clean expiratory cassette and press
it firmly down into lock position.
Important: Make sure that the cassette
clicks into position. Check that it cannot
be moved upwards and that the button
on top of the cassette is completely
ejected.
• Note on a log sheet that a routine cleaning
has been performed. Refer to hospital
routines.
8
SERVO-airVentilator System, User's Manual
| Patient unit and user interface |
2 |
2.3.2 Pre-use check
After cleaning, always perform a pre-use
check.
Refer to the ventilator system User's Manual.
If the pre-use check fails:
• Carefully shake/tilt the cassette (5-7 times).
• Run the cassette in a ventilator system with
a test lung for 10 minutes.
• Re-do the pre-use check.
2.4 Preventive maintenance
2.4.1 Check fan filters
Regularly check that the fan filter on both sides
looks clean (i.e. black). If dusty, remove (snap
off/snap on) and rinse in water. Shake out,
ensuring that the filter is free from excess
water.
2.4.3 Replace the dust filter
Check the dust filter and replace it once a
month or more often when necessary.
Note: The dust filter must be replaced. If it
is washed it will lose its characteristics.
• Open the air inlet filter lid by pressing the
two latches towards each other.
2.4.2 Check air inlet filter
The air inlet filter must be exchanged once a
year during preventive maintenance or more
often when necessary.
SERVO-airVentilator System, User's Manual
• Replace dust filter.
9
| Patient unit and user interface |
| 2
• Close the lid.
10
SERVO-airVentilator System, User's Manual
3 Expiratory cassette
3.1 Preparations
• Remove the expiratory cassette
Refer to section Remove the expiratory
cassette on page 7.
3.2 Disinfection
| Expiratory cassette |
3 |
There are two disinfection procedures for the
expiratory cassette and associated parts when
no bacterial filter is used:
• Washer-Disinfector (ISO 15883-1)
(recommended)
• Disinfectant
3.2.1 Washer-disinfector
If rinsing before disinfection is not included in
the washer disinfector program:
• Rinse the parts thoroughly in water
(<35°C/95°F).
• Let the water flow through the parts.
Important: Immediate rinsing in water
(<35°C/95°F) can remove particles and
reduces the risk of cross-contamination
between patients.
• Wash the parts with water only in a
washer-disinfector at a temperature of
85-95°C (185-203°F).
Refer to section Recommended intervals and
disinfectants on page 24.
• Place the expiratory cassette on its side
with the electrical connector uppermost.
Notes:
• The water pressure in the
washer-disinfector should not exceed
1.5 bar.
• The maximum water flow should not
exceed 10 l/min.
SERVO-airVentilator System, User's Manual
• The water must have free passage
through the cassette.
11
| Expiratory cassette |
| 3
3.2.2 Disinfectant
• Let the parts soak in disinfectant.
Refer to section Recommended intervals
and disinfectants on page 24.
Important: Follow the disinfectant
manufacturer’s recommendations and
instructions, otherwise the cassette may be
damaged or not disinfected properly.
Rinse after disinfection
Important:
Follow the disinfectant manufacturer's
recommendation and instructions regarding
rinsing.
Mineral deposits from disinfectant on the
expiratory cassette affect the function. It is
important to rinse the expiratory cassette
thoroughly. Residues from chemicals can
affect the patient, cause leakage and extra
stress on the material.
12
• Rinse the parts thoroughly in water to
remove all traces of disinfectant. Let the
water flow through the parts.
• Carefully shake and tilt the cassette, turn
upside down and repeat at least 5-7 times.
SERVO-airVentilator System, User's Manual
| Expiratory cassette |
3 |
3.3 Drying alternatives
Important: The expiratory cassette must
be dried before use (if not dry, the
expiratory cassette may not pass the
pre-use check).
Always shake/tilt the cassette carefully (5-7
times).
There are several drying alternatives for the
expiratory cassette:
• Drying cabinet 1 hour in maximum 70°C
(158°F); if available, connect a 22 mm air
hose to the expiratory cassette for extra
drying effect, or
• Drying the cassette in room air 12-24 hours,
depending on surrounding conditions.
3.3.1 Recommended position in a drying cabinet
3.3.2 Recommended position in room air
If the pre-use check is not passed after drying
then:
• Run the cassette in a ventilator system with
a test lung for 10 minutes, or
• Dry the cassette in room air (if no drying
cabinet is available) 12-24 hours, depending
on surrounding conditions.
Notes:
• Never dry the cassette by applying
high-pressure air as the internal tubing
may be damaged.
• Drying may not be necessary if the
washer-disinfector has a drying phase.
SERVO-airVentilator System, User's Manual
13
| Expiratory cassette |
| 3
3.4 Steam autoclaving
Note: Steam autoclaving procedures are
not recommended.
Steam autoclaving will reduce the lifetime of
the expiratory cassette and is not recommend
as a cleaning method.
Steam autoclaving is normally not necessary
for the expiratory cassette, as it is not an
invasive instrument, but when applied, use
validated processes only.
Refer to section Recommended intervals and
disinfectants on page 24.
3.4.1 Cleaning
• Clean before steam autoclaving.
Refer to section Washer-disinfector on
page 11.
3.4.4 Steam autoclave
Refer to section Recommended intervals and
disinfectants on page 24.
3.4.5 Drying after steam autoclaving
Refer to section Drying alternatives on
page 13.
3.5 Assembling
Refer to section Assembling on page 8.
3.4.2 Rinse
• Rinse the parts thoroughly in water
(<35°C/95°F).
• Let the water flow through the parts.
3.4.3 Drying before steam autoclaving
Before placing the expiratory cassette in a
steam autoclave, make sure that no water
remains inside the cassette.
Refer to section Drying alternatives on
page 13.
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SERVO-airVentilator System, User's Manual
4O2 cell (maintenance)
4.1 Preventive maintenance
Regularly check the cell status in quick menu
SYSTEM STATUS/O2 cell. The O2 cell should
be exchanged if <10% estimated remaining
capacity is indicated.
Refer to the ventilator system User's manuals
for O2 cell adjustment.
cell (maintenance) |
| O
2
4 |
4.2 Preparations
WARNING! The sealed unit of the O2 cell
contains a caustic liquid which may cause
severe burns to the skin and eyes. In case
of contact, immediately wash the affected
area continuously with water for at least 15
minutes and seek medical attention,
especially if the eyes are affected.
Important:
• Make sure the O2 cell is for the intended
ventilator model.
• Replacement of the O2 cell and filter and
extended cleaning must only be
performed by trained personnel.
• Unpack the O2 cell at least 15 minutes
before replacement. Turn the ventilator
system off using the on/off switch on the
patient unit.
• Disconnect the ventilator system from the
power and gas supply.
• Remove the expiratory cassette.
• Remove the front cover.
• Remove the O2 cell.
WARNING! The inspiratory channel cover
shall be kept in place once maintenance
has been performed. Otherwise the gas
modules can be affected and deliver the
wrong flow.
4.2.1 Remove the O2 cell
• Unfasten and turn out the locking latch.
• Disconnect the O2 cell connector.
SERVO-airVentilator System, User's Manual
15
| O2 cell (maintenance) |
| 4
• Remove the O2 cell.
4.3 Assembling
4.3.1 Insert the O2 cell
• Connect the O2 cell connector.
• Fasten the locking latch.
• Put the lower part of the front cover in
position.
• Press the upper part of the front cover into
position.
• Perform a pre-use check.
• Put the O2 cell in position.
16
SERVO-airVentilator System, User's Manual
5 Inspiratory channel (maintenance)
• Press the latch and gently pull out the
5.1 Preventive maintenance
Important: It is recommended that a regular
cleaning and an extended cleaning of the
inspiratory channel should be performed
before carrying out preventive maintenance.
5.2 Preparations
inspiratory channel.
• Disconnect the tube and remove the
bacterial filter. Discard the filter to
hazardous waste.
| Inspiratory channel (maintenance) |
5 |
• Remove the expiratory cassette.
• Remove the front cover.
• Remove the O2 cell.
Refer to section Remove the O2 cell on
page 15.
5.2.1 Remove inspiratory channel and tube
5.3 Disinfection
5.3.1 Rinse before disinfection
If rinsing before disinfection is not included in
the washer disinfector program:
• Rinse the parts thoroughly in water
(<35°C/95°F).
• Let the water flow through the parts.
Important: Immediate rinsing in water
(<35°C/95°F) can remove particles and
reduces the risk of cross-contamination
between patients.
SERVO-airVentilator System, User's Manual
17
| Inspiratory channel (maintenance) |
| 5
5.3.2 Washer-disinfector
• Place the inspiratory channel so that the
water flows through it.
Clean the inspiratory channel and tube
•
the same way as the expiratory cassette.
• Refer to section Disinfection on page 11.
5.4 Assembling
5.4.1 Insert inspiratory channel and tube
• Put a new bacterial filter in position and
connect the filter to the tube.
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SERVO-airVentilator System, User's Manual
• Push the inspiratory channel until it clicks
into locked position.
• Re-insert the O
Refer to section Insert the O
cell.
2
cell on
2
page 16.
• Mount the front cover.
Refer to section Assembling on page 16.
• Note on a log sheet that an extended
cleaning of the inspiratory channel has been
performed.
• Insert the expiratory cassette.
• Perform a pre-use check.
Refer to the ventilator system User's
Manual.
| Inspiratory channel (maintenance) |
5 |
SERVO-airVentilator System, User's Manual
19
| Aerogen Pro nebulizer |
| 6
6 Aerogen Pro nebulizer
6.1 Preparation
Important: Do not use abrasive or sharp
tools to clean the nebulizer unit.
Note: The Aerogen Solo nebulizer unit is
intended for single patient use only, do not
re-use, clean or sterilize.
Cleaning should be done after each patient or
according to hospital routines.
Disconnect the nebulizer unit from the control
cable, and remove the nebulizer unit, T piece
and adapters from the patient circuit or mask.
6.2 Wiping and discarding
6.3 Disinfection
6.3.1 Cleaning
• Ensure there is no medication remaining in
the nebulizer.
• Disassemble the nebulizer unit and adapters
into individual components.
• Remove the filler cap from nebulizer unit.
• Clean all parts with warm water and mild
liquid detergent.
• Rinse all parts in sterile water.
• Shake excess water from parts and allow
parts to air dry.
• Assemble the nebulizer.
Refer to the ventilator system User's
Manual.
• Wipe the control cable with a damp cloth.
Do not autoclave.
• Check for exposed wiring, damaged
connectors, or other defects and replace if
any are visible.
Note: In case of more contaminated
surfaces, use ethyl alcohol (70%).
20
6.3.2 Washer-disinfector
Two different washing cycles are validated for
the Aerogen Pro nebulizer:
• Liquid alkaline cleaner (diluted as per
manufacturer instruction) and mains water.
Load the components in the
-
washer-disinfector.
- Pre-rinse the components for 3 minutes.
- Clean the components with liquid alkaline
cleaner at 55 °C (131 °F) for 10 minutes.
- Rinse for 1 minute.
- Rinse using thermal disinfection cycle at
93 °C (199.4 °F) for 10 minutes.
• Mains water and without the use of a
detergent.
Load the components in the
-
washer-disinfector.
SERVO-airVentilator System, User's Manual
| Aerogen Pro nebulizer |
6 |
- Wash components for 10 minutes at 91
°C (195.8 °F).
- Drain the machine for 40 seconds.
- Rinse at 90 °C (194 °F) for 1 minute.
- Drain the machine for 40 seconds.
- Rinse at 90 °C (194 °F) for 1 minute.
- Drain the machine for 40 seconds.
- Dry at 90 °C (194 °F) for 15 minutes.
6.3.3 Disinfectant
• Immerse the parts in appropriate
disinfecting agent.
Refer to section Recommended intervals
and disinfectants on page 24.
Important: Follow the disinfectant
manufacturer’s recommendations and
instructions.
6.4 Steam autoclaving
• Disassemble the nebulizer unit and adapters
into individual components.
• Remove the filler cap from the nebulizer
unit.
• Clean all parts with warm water and mild
liquid detergent. Rinse thoroughly and air
dry.
• Check for cracks or damage and replace if
any defects are visible.
• Place the disassembled components into
appropriate sterilization wrapping.
Note: Do not reassemble parts prior to
steam autoclaving
Only the Aerogen Pro nebulizer unit, T piece
and neonate adapters can be autoclaved.
Refer to section Recommended intervals and
disinfectants on page 24.
SERVO-airVentilator System, User's Manual
21
| Aerogen Pro nebulizer |
| 6
Note: Sterilization using the long autoclave
cycle may cause some areas of the
nebulizer to become discolored. This does
not affect the performance of the nebulizer
unit.
To sterilize with hydrogen peroxide gas
plasma, place wrapped parts in a STERRAD®
System, and use the long cycle.
Note: Users should refer to the product
labelling for the STERRAD® 100S
Sterilization System for specific instructions
regarding its proper operation.
6.5 Assembling
Assemble the nebulizer.
Perform a function test of the Aerogen Pro
nebulizer after the cleaning.
Refer to the ventilator system User's Manual.
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SERVO-airVentilator System, User's Manual
7 Accessories
7.1 Hardware accessories
7.2 Patient circuits
| Accessories |
7 |
Hardware accessories are:
• Mobile cart
• Humidifier holder
• Support arm 179
• Water bag/IV pole
• Drawer
• Cabinet
• Gas cylinder restrainer kit
• Shelf base
• Hook and Y piece holder
• Cable holder
Refer to section Recommended intervals and
disinfectants on page 24.
Note: Discard the disposable patient
circuits. The disposable patient circuits are
for single patient use only.
Refer to the cleaning routines in the operating
manual for the patient circuit.
7.3 Humidifier
Fisher & Paykel Humidifier MR850/MR810
Refer to the cleaning routines in the operating
manual for the Fisher & Paykel Humidifier.
SERVO-airVentilator System, User's Manual
23
| Recommended intervals and disinfectants |
| 8
8 Recommended intervals and disinfectants
Patient unit and user interface
Surface cleaning
Expiratory cassette
Pre-disinfectant
Disinfectant
cycles
Cleaning agent
washer-disinfector
Steam autoclave
Number of cycles in
steam autoclave
• 3M Respirator Cleaning Wipes
• Clorox Bleach Germicidal Wipes (may cause discoloration)
• Super Sani-Cloth Germicidal Wipes (may cause discoloration)
• Virkon S
• Accel TB (Virox 5)
• In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl
alcohol (70%) together with lint free cleaning wipes.
• Aniosyme DD1
• Gigazyme Plus
• Salvanios pH7
Follow the disinfectant manufacturer's recommendation and instructions.
• Alcohol (ethyl or isopropyl alcohol 70%)
• Anioxyde 1000
• Cidex OPA
• Actanios HLD (prion decontamination agent), may cause discoloration
Follow the disinfectant manufacturer's recommendation and instructions.
at least 100 cyclesNumber of immersion
• neodisher® MediClean forte
• Getinge MIS Detergent
at least 200 cycles.Number of cycles in
• Instrument parts should be steam autoclaved in a validated process, at a
temperature of 134°C (273°F) for 3 minutes.
• Rubber parts should be steam autoclaved in a validated process, at a
temperature of 121°C (250°F) for 15-20 minutes.
The expiratory cassette will last at least:
• 100 autoclaving cycles with 3 minutes sterilization time at 134ºC (273ºF).
• 30 autoclaving cycles with 18 minutes sterilization time at 134ºC (273ºF).
O2 cell
24
Replace the O2 cell when it is requested by the ventilator system.O2 cell
SERVO-airVentilator System, User's Manual
Inspiratory channel
Pre-disinfectant
Disinfectant
cycles
Cleaning agent
washer-disinfector
Number of cycles in
steam autoclave
Aerogen Pro nebulizer
Pre-disinfectant
Disinfectant
steam autoclave
Steam autoclave
| Recommended intervals and disinfectants |
• Aniosyme DD1
• Gigazyme Plus
• Salvanios pH7
Follow the disinfectant manufacturer's recommendation and instructions.
• Alcohol (ethyl or isopropyl alcohol 70%)
• Anioxyde 1000
• Cidex OPA
• Actanios HLD (prion decontamination agent), may cause discoloration
Follow the disinfectant manufacturer's recommendation and instructions.
at least 10 cyclesNumber of immersion
• neodisher® MediClean forte
• Getinge MIS Detergent
at least 20 cycles.Number of cycles in
The inspiratory channel will last at least 10 autoclaving cycles with 3 minutes
sterilization time at 134ºC (273ºF).
• Hexanios G+R
Follow the disinfectant manufacturer's recommendation and instructions.
• Isopropyl alcohol (70 %)
• CIDEX
• NU-CIDEX
• Cidex OPA
at least 26 cyclesNumber of cycles in
Steam autoclaving can be performed using the following three methods:
• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a
minimum of 134°C (270°F - 275°F) for 3.5 minutes with drying cycle (134°C
wrapped cycle).
• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a
minimum of 121°C (250°F) for 20 minutes with drying cycle (121°C wrapped
cycle).
• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a
minimum of 134°C (270°F - 275°F) for 20 minutes with drying cycle
(sometimes referred to as a “Prion cycle”).
Note: This cycle may cause some areas of the nebulizer to become
discolored. This does not affect the performance of the nebulizer.
8 |
SERVO-airVentilator System, User's Manual
25
| Recommended intervals and disinfectants |
| 8
Accessories
Surface cleaning
Wipe the surface with a soft cloth moistened in soap and water or in
disinfectant.
In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl
alcohol (70%) together with lint free cleaning wipes.
26
SERVO-airVentilator System, User's Manual
x
Manufacturer: Maquet Critical Care AB
Röntgenvägen 2
171 54 Solna, Sweden
Phone: +46 (0) 10 335 73 00
www.maquet.com
For local contact:
Please visit our website
www.maquet.com
Getinge Group is a leading global provider of innovative solutions for
operating rooms, intensive-care units, hospital wards, sterilization
departments, elderly care and for life science companies and institutions.
With a genuine passion for life we build quality and safety into every
system. Our unique value proposition mirrors the continuum of care,
enhancing efficiency throughout the clinical pathway. Based on our
first-hand experience and close partnerships, we are able to exceed
expectations from customers – improving the every-day life for people,
today and tomorrow.
© Maquet Critical Care AB 2017. All rights reserved. • Maquet reserves the right to modify the design and specifications contained herein without prior notice.
• Order No. 68 82 040 • User's Manual • Printed in Sweden • 170223 • Rev: 03 English •
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