Professional Documents
Culture Documents
Cleaning and Sterilization
Cleaning and Sterilization
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
ISO 17664 compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cleaning information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Cleaning and maintenance schedule . . . . . . . . . . . . . . . . . . . . 6
Breathing system autoclavable parts . . . . . . . . . . . . . . . . . . . . 7
Breathing system removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Removing the breathing system bag hose . . . . . . . . . . . . .8
Removing absorber canister . . . . . . . . . . . . . . . . . . . . . . . .9
Removing the breathing system . . . . . . . . . . . . . . . . . . . . .9
Disassemble the breathing system . . . . . . . . . . . . . . . . . . . . 11
Breathing system disassembly . . . . . . . . . . . . . . . . . . . . .11
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Compatible chemical agents . . . . . . . . . . . . . . . . . . . . . . 13
Cleaning cassette kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Automated washer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Manual cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Assemble the breathing system . . . . . . . . . . . . . . . . . . . . . . . 23
Breathing system assembly . . . . . . . . . . . . . . . . . . . . . . . 23
Install the breathing system . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Bellows assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Disassemble the bellows assembly . . . . . . . . . . . . . . . . . 28
Assemble the bellows assembly . . . . . . . . . . . . . . . . . . . 30
Bellows assembly test . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Absorber canister . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Filling the reusable absorber canister . . . . . . . . . . . . . . . 35
Circuit O2 cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Index
2076865-001 i
ii 2076865-001
Cleaning and sterilization
Cleaning and sterilization
2076865-001 1
Intended use
This manual contains instructions for cleaning and sterilization of the
Carestation 600 series breathing system. Follow these instructions
for cleaning and sterilization of the system parts.
Important Use this manual along with the anesthesia system User’s Reference
manual. Always perform a preoperative checkout before using the
anesthesia machine after reassembly. The anesthesia system User’s
Reference manual contains a preoperative checkout list and
preoperative test instructions.
2 2076865-001
ISO 17664 compliance
The process for sterilization of the breathing system has been
validated by a third party firm and found to be in compliance with ISO
17664:2004.
These instructions have been validated by the manufacturer of the
medical device as being capable of preparing a medical device for
reuse. It remains the responsibility of the processor to make sure
that the reprocessing is actually performed using equipment,
materials, and personnel in the reprocessing facility achieve the
desired result. This requires validation and routine monitoring of the
process. Any deviation by the processor from the instructions
provided should be properly evaluated for effectiveness and potential
adverse consequences.
The manufacturer recommends the use of filter(s) that protect both
the inspiratory and expiratory ports to reduce the risk of cross-
contamination.
See "Breathing system removal", "Breathing system disassembly",
and "Sterilization".
Cleaning information
Clean the breathing system prior to first use after installation. Wash
and sterilize the breathing circuit separately. For the most effective
cleaning and sterilization, do not mix the breathing circuit with other
devices or components.
See "Compatible chemical agents" for a list of the approved cleaning
agents.
Immediately clean potentially infectious material, for example blood
or secretions, from the system by wiping the contaminated area
using a disposable cloth and an approved cleaning and disinfectant
agent.
Parts marked 134°C are autoclavable. All parts in the breathing
system, except the circuit O2 cell, flow sensors and bellows, can be
washed in an automated washer using mild detergent.
Only surface clean the circuit O2 cell. Do not autoclave the circuit O2
cell. Do not wash the circuit O2 cell, flow sensors or bellows in an
automated washer.
A Cleaning Cassette kit is available to assist in the cleaning of the
breathing system when using an automatic washer.
Always perform a preoperative test after reassembly and prior to
use. The anesthesia system User’s Reference manual contains a
preoperative checkout list and preoperative test instructions. Inspect
and replace any damaged parts in the breathing system, if the test
failed.
2076865-001 3
• Read and understand the material safety data sheet
for each cleaning agent.
• Read and understand the manual for all sterilization
equipment to be used.
• Follow facility guidelines for use of personal
protective equipment during cleaning and sterilization
procedures.
• A damaged O2 cell can leak and cause burns. Do not
breathe the fumes.
4 2076865-001
harsh cleaning agents. Doing so can damage the
labels or the system.
• Do not use abrasive cleaning agents (such as steel
wool, silver polish or cleaner).
• Keep all liquids away from electronic parts.
• Do not permit liquid to go into the equipment
housings.
• Do not soak parts for more than 15 minutes. Swelling
or accelerated aging can occur.
• Only autoclave parts marked 134°C. Do not exceed
134°C.
• Cleaning solutions must have a pH of 7.0 to 10.5.
Organic, halogenated or petroleum-based solvents,
anesthetic agents, glass cleaners, acetone, and other
harsh cleaning agents should not be used.
2076865-001 5
Cleaning and maintenance schedule
Refer to the anesthesia system’s User’s Reference manual for
complete maintenance instructions regarding the anesthesia system.
Minimum Frequency
Before each patient
• Clean the anesthesia system’s external
surfaces.
As necessary
• Clean the anesthesia system’s external
surfaces.
• Empty the absorber canister body and replace
the absorbent in the canister.
• Empty the overflow trap on the optional
suction regulator.
• Replace the circuit O2 cell. (Under typical use
the cell meets specifications for 2 years).
• Replace the autoclavable flow sensors.
(Under typical use the sensor meets
specifications for a minimum of 1 year.)
6 2076865-001
Breathing system autoclavable parts
6
AC.24.172
2076865-001 7
Breathing system removal
The breathing system patient circuit, bag hose, and canister must be
removed before removing and disassembling the breathing system.
AC.24.328
2. Remove the bag from the holder at the end of the bag arm.
3. Remove the bag hose from the clip and the bag arm base.
3
AC.24.325
1. Holder
2. Clip
3. Bag arm base
8 2076865-001
Removing absorber canister
1. Pull down the canister lifter handle to unlock the canister from
the breathing system.
AC.24.071
2. Lift the canister and remove it from the canister lifter base.
AC.24.072
2076865-001 9
AC.24.154
AC.24.155
2. Grasp the breathing system base, rotate down and pull the
assembly away from the anesthesia machine.
AC.24.156
10 2076865-001
Disassemble the breathing system
The breathing system assembly can be disassembled for cleaning,
sterilization, and part replacement.
1. Push the patient port assembly tab and pull the assembly from
the breathing system.
AC.24.157
2. Pull out both of the flow sensors.
AC.24.158
2076865-001 11
3. Remove the APL valve diaphragm assembly.
AC.24.159
12 2076865-001
Cleaning
Use the recommended method to clean the breathing system parts.
See "Compatible chemical agents" for a list of cleaning agents that
have been tested and found to cause no harm to breathing system
parts.
The compatible chemical agents listed have been tested and found
not to cause harm to the anesthesia system parts. Read the material
safety data sheet (MSDS) for each chemical agent. Use of these
chemicals will not damage the components when used as
suggested, but efficacy of cleaning or disinfection has not been
demonstrated in all cases.
The compatible chemical agents listed may not be available or
approved for use in all countries. Follow hospital guidelines for
cleaning and chemical agent use.
2076865-001 13
Chemical agent Concentration
Manual cleaning Prolystica 2x Neutral 4 ml per liter of water
Detergent Neutral,
Steris
2
4
AC.24.179
6
7 8
14 2076865-001
6. Bag port plug
7. Negative pressure valve plug
8. Base assembly
AC.24.204
2076865-001 15
AC.24.177
5. Attach 22-mm hoses to the expiratory port, bypass port, and bag
port.
AC.24.178
16 2076865-001
AC.24.323
Automated washer
The breathing system components can be cleaned using an
automated washer. Remove all visible contaminants from the parts
prior to automated washing.
Read and understand the manufacturer’s instruction manual for the
automated washing equipment prior to use.
Cleaning cassette kits are available to enhance the cleaning of the
breathing system parts in an automated washer.
2076865-001 17
3. Place the components in the washer tray and load into an
automatic washer. Place the components with the cavity side
facing downwards to easily drain the cleaning water.
4. Use Prolystica Ultra Concentrate Neutral Detergent as the
cleaning agent. Set the dispense rate to 0.8 ml per liter of water.
5. Follow the automated washer operation procedure.
18 2076865-001
4. Unload the parts from the automated washer.
5. Drain the water from the parts.
6. Allow the parts to cool and dry in room air.
Do not wipe the parts during the drying process.
7. After the parts have completely cooled and dried, check the
parts for damage and/or deterioration, such as deformation or
cracking. Replace or repair as necessary.
Manual cleaning
Soaking method
1. Mix a mild detergent solution.
2. Wash and soak the parts in the mild detergent solution for a
minimum of 5 minutes in a clean soaking tray.
• Make sure that all the surfaces of the parts are submerged
and no air bubbles are visible.
• Gently agitate the parts to remove and dislodge any debris.
• Use a soft, plastic brush to remove stubborn debris from
external surfaces only.
3. Remove the parts from the from the detergent solution. Rinse
the parts in distilled water between 20°C to 25°C. Rinse the
parts again in distilled water between 25°C to 30°C. Allow the
parts to air dry.
2076865-001 19
• Do not wipe parts surfaces during the drying process.
20 2076865-001
Sterilization
The breathing system can be loaded into standard sterilization trays.
Do not exceed the maximum load of the sterilization tray. The
approximate weight of the breathing system is 2.5 kg (5.5 lb). All
parts should be cleaned prior to autoclaving. Do not block any ports
of the breathing system when placing parts in the sterilization tray.
Steam should be able to freely enter all components during
autoclaving.
Read and understand the manufacturer’s instruction manual for the
autoclave equipment prior to use.
AC.24.232
2076865-001 21
9. Dry the parts for 20 minutes before reassembly.
AC.24.371
--
10. Allow the parts to cool and dry completely before reassembling
the breathing system.
11. In accordance with application requirements, store the sterilized
parts in the original sterilization wrap to guard against
contamination.
12. Remove the light gauge sterilization wrap prior to reassembly.
13. Visually inspect all parts for deterioration such as deformation
and cracking.
14. Inspect the parts for damage. Replace or repair as necessary.
22 2076865-001
Assemble the breathing system
Complete the "Assemble the bellows assembly" and "Breathing
system disassembly" procedures to reassemble the breathing
system.
AC.24.171
2. Confirm check valves are properly installed in both inspiratory
and expiratory side of breathing system.
AC.24.353
3. Insert the flow sensors into the flow sensor holders. Make sure
the flow sensors are installed as shown in the illustration below.
2076865-001 23
AC.24.170
24 2076865-001
AC.24.169
2076865-001 25
Install the breathing system
1. Align the breathing system base with the guide pins, holding the
breathing system at approximately a 45 degree angle.
AC.24.301
2. Push the breathing system into the anesthesia machine, holding
the breathing system at approximately a 45 degree angle, so it
may slide between the canister lifter and breathing system top
without interference.
AC.24.168
26 2076865-001
AC.24.367
5. Install the absorber canister and lift handle to engage canister
with breathing system. Install bag hose.
6. Always perform a preoperative checkout before using the
anesthesia machine after reassembly. The anesthesia system
User’s Reference manual contains a preoperative checkout list
and preoperative test instructions.
2076865-001 27
Bellows assembly
The bellows assembly can be disassembled for sterilization and part
replacement.
AC.24.148
2. Push the latches toward the center and remove the bellows with
the rim.
28 2076865-001
AC.24.296
2076865-001 29
AC.24.151
WARNING Do not disassemble the pressure-relief valve. This can
damage the seat or diaphragm and cause injury to the
patient.
--
4. Lift up and remove the bellows base with the latch and seal.
AC.24.297
1. Install the bellows base to the top housing. Align the vent port
and press down on the bellows base to make sure it is installed
correctly.
30 2076865-001
AC.24.299
2. Install the pressure-relief valve.
AC.24.151
3. Align the pressure-relief valve and attach the bellows with the
rim to the bellows base. Press down on the bellows base and a
double-click should be heard when the rim is installed. Pull up
on the bellows to make sure it is locked.
2076865-001 31
AC.24.300
4. Lower the bellows housing and turn it clockwise to lock. Verify
the housing is secure and the guidelines are facing forward.
AC.24.148
32 2076865-001
Bellows assembly test
Perform this test to make sure that the bellows assembly
components are correctly assembled. This test is not an alternative
to a complete system checkout. If the bellows assembly functions
correctly, continue with the assembly of the breathing system. If the
bellows assembly does not function correctly, verify proper
assembly, and look for and replace any damaged parts.
WARNING Objects in the breathing system can stop gas flow to the
patient. This can cause injury or death:
1 2
2076865-001 33
2. Drive gas out port
4. Invert the bellows assembly. The bellows must not fall any
amount within one minute. If it falls, check for the following:
5. Remove the plugs from the ports. Permit the bellows to fully
extend.
6. Use the appropriate test plugs to seal the vent port (21.4 mm)
and sample gas port (4 mm).
1 2
AC.24.176
1. Vent port
2. Sample gas port
7. Hold the bellows assembly upright. The bellows must not fall
past the top guideline within one minute. If it falls, check for the
following:
34 2076865-001
Absorber canister
The absorber canister is available in two versions: disposable
absorber and reusable absorber. Only the reusable absorber
canister may be cleaned.
Discard the used absorbent and any liquid in the canister body
before cleaning and filling the absorber canister.
AC.24.078
2. Push the latch handle down to release the cover.
AC.24.079
3. Pull the latch hook away from the canister and lift the cover off
the canister.
AC.24.082
2076865-001 35
4. Remove and properly discard the absorbent and any water in
the canister body.
Note The top cover wiper seal may discolor over time, however color
change alone has no effect on seal function.
--
9. Insert the cover into the groove on the canister handle so that
the arrows get covered by the black zone.
AC.24.081
10. Attach the cover latch hook to the canister body. Push the latch
handle down until it is flush with the canister cover.
AC.24.368
36 2076865-001
Refer to the User’s Reference Manual for the "Preoperative
checkout".
2076865-001 37
Circuit O2 cell
Do not get the circuit O2 cell wet. Clean the circuit O2 cell by wiping
it with a damp cloth.
38 2076865-001
Index
A K
Absorber canister Kit
reusable 35 cleaning cassette 14
Automated washer 17
Automated washing M
with cleaning cassette 18
without cleaning cassette 17 Maintenance schedule 6
Manual cleaning 19
B
O
Bag hose removal 8
Bellows assembly O2 cell
assembly 30 cleaning 38
disassembly 28
test 33 S
Breathing system Sterilization 21
assembly 23
autoclavable parts 7
disassembly 11
installation 26
removal 8
C
Canister
remove 9
Circuit O2 cell 38
Cleaning
agents 13
APL diaphragm 19
flow sensors 19
information 3
Cleaning agents 13
Cleaning cassette
attaching to the breathing
system 15
using 18
I
Intended use 2
ISO 17664 compliance 3
2076865-001 I-1
I-2 2076865-001
Cleaning and Sterilization
User's Reference Manual
English
2076865-001
03 2015 Rev F