Dräger Isolette 8000 plus User manual

Isolette 8000 plus
Incubator
Supplement to the instructions for use
WARNING
To properly reprocess the products, read and comply
with this document.
Isolette 8000 plus

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Contents
Isolette 8000 plusIncubator
Contents
1Information about this document ........................................................... 4
1.1 Trademarks..................................................................................... 4
2Reprocessing............................................................................................ 5
2.1 Safety instructions .......................................................................... 5
2.2 Safety information........................................................................... 5
2.3 Information on reprocessing ........................................................... 6
2.4 Classifications for reprocessing ...................................................... 6
2.5 Before reprocessing........................................................................ 7
2.6 Validated reprocessing procedures ................................................ 13
2.7 Other agents and reprocessing procedures ................................... 17
2.8 After reprocessing........................................................................... 19
Index.......................................................................................................... 27

4 Supplement to the instructions for use | Isolette 8000 plus
Information about this document
1 Information about this document
Keep this supplement with the instructions for use.
This supplement updates the information given in the instructions for use in the
following chapters: Information about this document, For your safety and that of
your patients, and Reprocessing
1.1 Trademarks
1.1.1 Trademarks owned by Dräger
The following web page provides a list of the countries in which the trademarks are
registered: www.draeger.com/trademarks
1.1.2 Trademarks owned by third-party manufacturers
Instructions for use Part number Edition
Isolette 8000 plus MU25944 4 – and higher
Trademark
Dräger®
Isolette®
Softbed®
Trademark Trademark owner
Dismozon BODE Chemie
Neodisher mediclean Dr. Weigert
acryl-des
Schülke & Mayr
Buraton
Mikrozid
Perform
terralin protect
Virkon DuPont
Actichlor Ecolab USA
Oxycide
BruTab 6S Brulin
Clorox Professional Clorox
Dispatch
Klorsept Medentech
Descogen Antiseptica

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Reprocessing
2 Reprocessing
2.1 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 where applicable.
►Reprocess reusable products after every use.
►Follow the manufacturer's instructions for cleaning agents, disinfectants, and
reprocessing devices.
2.2 Safety information
Electrical hazards
An electrical shock hazard exists when performing cleaning or maintenance
procedures.
►Unplug the power cable (AC or DC) from its power source.
Explosion hazard
A fire and explosion hazard exists when performing cleaning and maintenance
procedures in an oxygen-enriched environment.
►When performing cleaning and maintenance procedures, confirm that the
oxygen supply is turned off and that the equipment is disconnected from the
oxygen supply.
►Switch off or disconnect oxygen supplies during periods of non-use.
►Ensure that oxygen connectors are free from grease and oil.
Equipment damage
Reusing, reprocessing, or sterilizing disposable items can lead to a failure of the
medical device and cause injury to the patient.
►Do not reuse, reprocess, or sterilize disposable items. Disposable items were
designed, tested, and manufactured for one-time use only.
Humidity
Any open gaps in the incubator hood reduce the incubator internal relative humidity.
►Make sure that all hand port gaskets and tubing grommets are properly installed
on the hood.
Faulty products
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with
reprocessed products.
►Check the products for signs of wear and replace them if necessary..

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Accessories and components
Accessories and optional components could fall off the device.
►Before disassembling the hood and shell assemblies, remove accessories and
optional components mounted to device.
Cleaning
For routine cleaning of the Isolette 8000 plus, there is no need to separate the hood
and shell assemblies from the trolley.
►If separation is necessary, contact DrägerService.
Some chemical cleaning agents may be conductive and leave a residue that may
permit a build-up of conductive dust or dirt.
►Do not allow cleaning agents to contact electrical components, and do not spray
cleaning solutions onto any of these surfaces.
►Use a cloth dampened with disinfectant. Do not spray cleaning solution directly
onto the surface of the device.
Harsh cleaning methods can damage equipment
►Do not use harsh cleansers/detergents such as scouring pads or heavy-duty
grease removers or solvents, such as acetone.
2.3 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).
2.4 Classifications for reprocessing
2.4.1 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.
2.4.2 Classification of device-specific components
The entire device must be reprocessed. Observe the following classification and the
instructions for use for the components. The following is a recommendation from
Dräger.
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

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2.5 Before reprocessing
Observe before disassembly
1. Switch off the device and all devices connected to it.
2. Disconnect all power plugs.
2.5.1 Patient-specific accessories and consumables
The patient-specific accessories and consumables must be removed from the
device and, if necessary, disassembled.
Disposable products:
●Dispose of the disposable products.
2.5.2 Device-specific components
The device-specific components must be removed from the device and, if
necessary, disassembled.
Removing the scale and the bed and related components
1. Disconnect the cables from the sensor module.
2. Slowly raise the hood (A).
Classification Device-specific components
Non-critical Device surface including controller display
Trolley and holders
Hood and walls
Gaskets, grommets
Humidity system
Removable parts of the main system
Semi-critical None
Critical None
49640
B
C
D
E
E
F
A

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3. Remove the mattress (B).
4. If the incubator is equipped with a weighing scale, perform steps 5 through 7;
otherwise go to step 7.
5. Disconnect the scale cable from the sensor module.
6. Remove the cable from the clamps that hold it to the incubator.
7. Lift the scale (C) from the bed.
8. Remove the bed (D) and X-ray tray (inside bed)
9. Remove the T-bars (E).
10. Remove upper cover (F).
Removing the heater radiator and impeller
1. On devices without the humidification system option, remove the heater/impeller
cover (A).
2. On devices with the optional humidification system, pull the water reservoir
partially out, and remove the heater/impeller cover (B) and the duct cover (C).
WARNING
Risk of death or serious injury
The heater can be sufficiently hot to cause burns.
►Avoid removing or touching the heater until the device has been switched off
for at least 45 minutes.
3. When the device has cooled, remove the heater radiator (D).
4. Pull the impeller (E) off the motor shaft.
48107
A
B
C
D
E

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Removing the drain plug with O-ring (if installed)
1. Remove the drain plug with O-ring (A) at the bottom of the heater well on
devices without the condensation management system.
Removing the condensation management system (if installed)
CAUTION
Risk of injury or damage to the device
Reuse of single-use components can cause patient injury or damage the device.
►Do not reprocess and reuse single-use components.
CAUTION
Risk of injury or damage to the device
Fluid spills or leaks could cause a slip hazard.
►If any fluids spill or leak around the device, wipe the area dry.
CAUTION
Risk of injury or damage to the device
Liquid in the collection bottle can contain patient fluids.
►Collection bottles and fluids should be handled according to hospital guidelines.
When using high levels of humidity, Dräger recommends using the optional
condensation management system.
1. Ensure bed, scale, heater radiator and impeller are removed.
2. Disconnect the condensation management hose (A) from the collection bottle
located underneath the left side of the incubator.
3. Remove the clamp (B) from the condensation management hose and discard.
4964348109
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B

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4. Remove the condensation management hose:
a. Turn the plug (C) at the bottom of the heater well 90 degrees
counterclockwise.
b. Pull the hose/plug assembly out completely (D).
5. Discard the collection bottle and hose/plug assembly.
Removing the manifold (if installed)
1. On devices without the humidification system option, remove the manifold from
the shell by pulling up on it. Set aside.
482754810848103
C
D

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Removing the water reservoir assembly (if installed)
1. Pull the latch forward and slide the reservoir assembly out from the front of the
incubator shell.
WARNING
Risk of death or serious injury
The humidifier and the water in the humidifier chamber can be sufficiently hot to
cause burns.
►Avoid removing or touching the humidifier until the water reservoir has been
disconnected from the incubator for at least 45 minutes.
►Use caution when emptying or handling the reservoir.
2. Pull the latch on top of the water reservoir lid forward, and remove the lid (A).
3. Empty any water remaining in the reservoir.
NOTICE
Risk of damage to the device
Sharp tools can cause injury or damage the device.
►Do not use sharp tools to remove the humidifier.
CAUTION
Risk of injury or damage to the device
Liquid in the collection bottle can contain patient fluids.
►Collection bottles and fluids should be handled according to hospital
guidelines.
4. Lift the latches on the side of the water reservoir (B) and remove the humidifier
(C) from the humidifier chamber.
4810048101
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C
B
B

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Removing the sleeves (if installed), hand port gaskets, and hose grommets
1. Open the hand port doors and remove the sleeves, if installed.
2. Pull the hand port gaskets (A) from all sides of the hood to remove them.
3. Pull the hose grommets (B) from each side of the hood to remove them.
4. Wipe the retainer rings clean, if installed.
5. Discard disposable sleeves, if installed.
Removing the air inlet filter
1. Loosen the two thumbscrews (A) on the air inlet filter cover located under the
shell assembly on the rear of the device.
2. Remove the air inlet filter cover.
3. Remove the air inlet filter.
4. Discard the air inlet filter.
4964948102
A
B
AA

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2.6 Validated reprocessing procedures
2.6.1 Overview of the reprocessing procedures of the components
2.6.2 Surface disinfection with cleaning
Components:
– Device surface including controller screen
– Trolley, rail, and holders
– Hood and walls
– Gaskets and grommets
– Removable parts of the main system
Surface disinfection using the following surface disinfectant is suitable for the
device and all components:
Components Surface disin-
fection with
cleaning
Manual clean-
ing followed by
disinfection by
immersion
Machine
cleaning
with ther-
mal disin-
fection
Description of
the procedure
Device surface
including con-
troller screen
Yes No No (see "Surface
disinfection
with cleaning",
page 13)
Trolley, rail,
and holders
Yes No No (see "Surface
disinfection
with cleaning",
page 13)
Hood and walls Yes No No (see "Surface
disinfection
with cleaning",
page 13)
Gaskets, grom-
mets
Yes No No (see "Surface
disinfection
with cleaning",
page 13)
Removable
parts of the
main system
Yes No No (see "Surface
disinfection
with cleaning",
page 13)
Humidity sys-
tem (if
installed)
No No Yes (see "Machine
cleaning with
thermal disin-
fection",
page 16)
Surface disinfec-
tant
Manufacturer Concentration Contact time
Dizmozon plus BODE Chemie 1.6 % 15 min

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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.
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.
Supplementary information
Do not spray cleaning solution directly onto the surface of the device.
Do not spray cleaning solution into the openings of the sensor module to avoid
moisture on to the electronic components.
Reprocessing the shell, trolley, and condensation management bracket (if
installed):
CAUTION
Risk of injury or damage to the device
Liquid could damage the motor shaft.
►When cleaning the interior of the incubator shell, prevent liquids from entering
the motor shaft.
►When cleaning the surface of the air circulation well, prevent liquids from
entering the motor shaft opening.

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CAUTION
Risk of injury or damage to the device
On devices with the condensation management system option, the hose/plug
assembly is disposable.
►Do not clean and reuse the hose/plug assembly.
1. Wipe any fluids that may have accumulated in the heater well. Take special care
to clean and disinfect the heater well, the drain plug opening, and the drain plug
(on devices without the humidification system option).
2. Check for fluids that may have dripped onto the bottom surface of the water
reservoir or humidity tray opening. If fluids are present, use a clean paper towel
dampened with a cleaner/disinfectant to wipe the surfaces dry.
3. Follow surface disinfection recommendations to wipe with a cloth dampened
with disinfectant. Do not spray cleaning solution directly onto the surface of the
device.
Reprocessing the controller and the sensor module
1. When reprocessing the underside of the controller near the on/off switch, follow
surface disinfection recommendations to wipe with a cloth dampened with
disinfectant. Do not spray cleaning solution directly onto the surface of the
device. Avoid getting cleaning agent in the openings.
2. Clean all surfaces thoroughly, including the controller and sensor module.
3. Be sure to clean all holes and indentations; then dry with a clean cloth or paper
towel.
Reprocessing the hood, and inner double walls
NOTICE
Risk of damage to the device
Alcohol and Ultraviolet radiation can cause cracking and/or crazing (small stress
cracks) of the clear acrylic.
►Do not use alcohol for cleaning.
►Do not expose the clear acrylic to direct radiation from germicidal lights.
1. To release the inner double wall, press the catches (A) at the top of the inner
double wall.
The inner double walls are hinged on the access panels of the incubator.
2. Clean all surfaces of the hood thoroughly, including the inner double walls, hand
ports, and access panels. Do not spray cleaning solution directly onto the
surface of the device.
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A

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3. Be sure to clean all holes and indentations; then dry with a clean cloth or paper
towel.
Reprocessing the heater radiator and fan impeller
WARNING
Risk of death or serious injury
Failure to clean the heater radiator and fan impeller could result in sufficient lint
build-up to reduce airflow. Reduced airflow could affect the temperature control and
cause high oxygen concentrations.
►Clean heater radiator and fan impeller.
CAUTION
Risk of injury or damage to the device
Damage can occur to the motor if liquid penetrates the area.
►When cleaning the incubator shell, prevent liquids from entering the motor shaft
opening.
►When cleaning the surface of the air circulation well, prevent liquids from
entering the motor shaft opening.
CAUTION
Risk of injury or damage to the device
Autoclaving can damage equipment or impact functional integrity.
►Do not steam sterilize parts when disassembling for cleaning.
1. Remove any lint build-up on the heater radiator and fan impeller.
2. Wipe the heater assembly.
Do not immerse the heater assembly in liquid.
Reprocessing the air inlet filter chamber and cover
WARNING
Risk of death or serious injury
A dirty air inlet filter could affect performance or cause carbon dioxide (CO2)
buildup.
►Ensure that the filter is checked on a routine basis commensurate with local
conditions and replaced as recommended in Maintenance on page 149.
Particularly, if the device is used in an unusually dusty environment, more
frequent replacements may be necessary.
Do not clean the air inlet filter.
1. Clean the filter chamber and its cover.
2. Install a new air inlet filter.
2.6.3 Machine cleaning with thermal disinfection
Use a washer-disinfector that meets the requirements of the standard ISO 15883.
Follow the manufacturer's instructions for the washer-disinfector.
Components:
– Humidity system

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Prerequisites:
– The washer-disinfector has been prepared in accordance with the
manufacturer's instructions.
Positioning the components in the load carrier
1. Position the components horizontally, in an open basket or directly on the tray to
be stable.
2. Ensure the following:
– All surfaces and interiors can be completely rinsed.
– The water can drain off freely.
Performing reprocessing
1. Select a cycle.
2. Use demineralized water for the final rinse.
3. When the cycle has ended, check the components for visible soiling and repeat
the cycle if necessary.
4. Check the components for visible damage and replace if necessary.
5. Allow the product to dry completely.
2.6.4 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.
2.7 Other agents and reprocessing procedures
2.7.1 Disinfectants
Use nationally approved disinfectants suitable for the respective reprocessing
process and the intended application.
Step Agent Manufac-
turer
Concentra-
tion
Temperature Contact time
Cleaning Neodisher Medi-
Clean forte
Dr. Weigert _ Min. 90 °C
(194 °F)
Min. 5 min1)
1) Machine run times may vary depending upon your washer-disinfector temperature settings
Flushing Demineralized
water
– – Tap water tem-
perature
Min. 1 min
Disinfecting Neodisher Medi-
Clean forte
Dr. Weigert – Min. 90 °C
(194 °F)
Min. 5 min
Drying – – – – Drying time
depends on the
load

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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 Clorox Professional Disinfect-
ing Bleach Cleaner
Clorox EPA1)
1) United States Environmental Protection Agency
Dispatch Hospital Cleaner
Disinfectant Towels with
Bleach
Chlor-Clean Tablets helix Solution ARTG2)
2) Australian Register of Therapeutic Goods
Actichlor plus Ecolab USA -
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
Robysta Kyroin (Japan) -
Rely+On Virkon DuPont EPA
Quaternary
ammonium com-
pounds
acryl-des3)
3) Virucidal against enveloped viruses
Schülke &
Mayr
CE
Mikrozid alcohol free liquid3)
Mikrozid alcohol free wipes3)
Mikrozid sensitive liquid3)
Mikrozid sensitive wipes3)
Cleanisept Wipes Maxi Dr. Schum-
acher
CE
Surfa'Safe Premium ANIOS Labo-
ratories
CE
Wip'Anios Excel
Tuffie 5 Vernacare ARTG

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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.
For disinfectant recommendations for the SoftBed mattress, consult their
manufacturer instructions for use.
2.8 After reprocessing
2.8.1 Assembling and fitting device-specific components
Prerequisites:
– All components have been reprocessed and dried.
– All components have been inspected for breakage or cracks, and replaced if
necessary.
Assembling the water reservoir assembly
1. On devices with the humidification system option:
a. Install the humidifier (A) into the water reservoir assembly. Insert it fully into
the humidifier chamber and secure it by closing the 2 latches (B).
b. Install the lid on the water reservoir and push back the latch (C) on top of the
lid to secure it.
c. Insert the water reservoir assembly in the shell with the latch (D) open. Then
slide it in fully and lock it in place by pushing in the latch.
4965048251
A
B
B
C
D

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Fitting the manifold
1. On devices without the humidification system option, reinstall the manifold.
Fitting the drain plug
1. On devices without the condensation management system, reinstall the drain
plug (A) in the bottom of the heater well.
Fitting the condensation management system (if installed)
1. On devices with the condensation management system, install a new collection
bottle (A).
481034964348276
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A
D
E