Dräger Isolette 8000 plus Manual de usuario
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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Reprocessing
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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Reprocessing
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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Reprocessing
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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Reprocessing
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
A
A
B
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Reprocessing
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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