Isolette 8000 plus Supplement to instructions for use Ed 1 July 2020

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Supplement to the instructions for use

| Isolette 8000 plus

Contents

Contents Isolette 8000 plus Incubator

1

2

Information about this document ...

4

1.1

Trademarks...

4

Reprocessing...

5

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

Safety instructions ... Safety information... Information on reprocessing ... Classifications for reprocessing ... Before reprocessing... Validated reprocessing procedures ... Other agents and reprocessing procedures ... After reprocessing...

5 5 6 6 7 13 17 19

Index ...

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Information about this document

1

Information about this document Instructions for use

Part number

Edition

Isolette 8000 plus

MU25944

4 – and higher

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 Trademark Dräger® Isolette® Softbed® 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 Trademark

Trademark owner

Dismozon

BODE Chemie

Neodisher mediclean

Dr. Weigert

acryl-des Buraton Mikrozid

Schülke & Mayr

Perform terralin protect Virkon Actichlor Oxycide BruTab 6S Clorox Professional Dispatch

4

DuPont Ecolab USA Brulin Clorox

Klorsept

Medentech

Descogen

Antiseptica

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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 healthcare 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. Classification Non-critical Semi-critical Critical

2.4.2

Explanation Components that come into contact only with skin that is intact Components that carry breathing gas or come into contact with mucous membranes or pathologically altered skin Components that penetrate skin or mucous membranes or come into contact with blood

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.

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Classification Non-critical

Device-specific components Device surface including controller display Trolley and holders Hood and walls Gaskets, grommets Humidity system Removable parts of the main system None None

Semi-critical Critical

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 49640

1. Disconnect the cables from the sensor module.

B

C

A

D E E F

2. Slowly raise the hood (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

48107

1. On devices without the humidification system option, remove the heater/impeller cover (A).

C A B

D E

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.

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Removing the drain plug with O-ring (if installed)

49643

1. Remove the drain plug with O-ring (A) at the bottom of the heater well on devices without the condensation management system.

A

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.

48109

2. Disconnect the condensation management hose (A) from the collection bottle located underneath the left side of the incubator.

B A

3. Remove the clamp (B) from the condensation management hose and discard.

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4. Remove the condensation management hose:

48275

a. Turn the plug (C) at the bottom of the heater well 90 degrees counterclockwise.

C

D

48108

b. Pull the hose/plug assembly out completely (D).

5. Discard the collection bottle and hose/plug assembly. Removing the manifold (if installed)

48103

1. On devices without the humidification system option, remove the manifold from the shell by pulling up on it. Set aside.

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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.

48100

2. Pull the latch on top of the water reservoir lid forward, and remove the lid (A).

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.

48101

4. Lift the latches on the side of the water reservoir (B) and remove the humidifier (C) from the humidifier chamber.

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. 49649

2. Pull the hand port gaskets (A) from all sides of the hood to remove them.

A

B

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

48102

1. Loosen the two thumbscrews (A) on the air inlet filter cover located under the shell assembly on the rear of the device.

A

A

2. Remove the air inlet filter cover. 3. Remove the air inlet filter. 4. Discard the air inlet filter.

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2.6

Validated reprocessing procedures

2.6.1

Overview of the reprocessing procedures of the components Components

2.6.2

Surface disin- Manual cleanfection with ing followed by cleaning disinfection by immersion

Device surface Yes including controller screen

No

Machine cleaning with thermal disinfection No

Trolley, rail, and holders

Yes

No

No

Hood and walls Yes

No

No

Gaskets, grom- Yes mets

No

No

Removable parts of the main system

Yes

No

No

Humidity system (if installed)

No

No

Yes

Description of the procedure

(see "Surface disinfection with cleaning", page 13) (see "Surface disinfection with cleaning", page 13) (see "Surface disinfection with cleaning", page 13) (see "Surface disinfection with cleaning", page 13) (see "Surface disinfection with cleaning", page 13) (see "Machine cleaning with thermal disinfection", page 16)

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: Surface disinfectant Dizmozon plus

Manufacturer

Concentration

Contact time

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.

48157

1. To release the inner double wall, press the catches (A) at the top of the inner double wall.

A

A

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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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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Step Cleaning Flushing Disinfecting Drying

Agent

Manufacturer Neodisher Medi- Dr. Weigert Clean forte Demineralized – water Neodisher Medi- Dr. Weigert Clean forte – –

Concentration _ – – –

Temperature

Contact time

Min. 90 °C (194 °F) Tap water temperature Min. 90 °C (194 °F) –

Min. 5 min1) Min. 1 min Min. 5 min Drying time depends on the load

1) Machine run times may vary depending upon your washer-disinfector temperature settings

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.

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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 Chlorine-releasing agents

Oxygen-releasing agents

Surface disinfectant

Clorox Professional Disinfect- Clorox ing Bleach Cleaner Dispatch Hospital Cleaner Disinfectant Towels with Bleach Chlor-Clean Tablets helix Solution Actichlor plus Descogen Liquid Descogen Liquid r.f.u. Oxygenon Liquid r.f.u. Dismozon plus Oxycide Perform SteriMax Wipes Incidin OxyWipes Robysta Rely+On Virkon

Quaternary ammonium compounds

Manufacturer Listing

acryl-des3) Mikrozid alcohol free liquid3)

Ecolab USA Antiseptica

EPA1)

ARTG2) CE

BODE Chemie CE Ecolab USA EPA Schülke & CE Mayr Aseptix CE Ecolab USA CE Kyroin (Japan) DuPont EPA Schülke & CE Mayr

Mikrozid alcohol free wipes3) Mikrozid sensitive liquid3) Mikrozid sensitive wipes3) Cleanisept Wipes Maxi Surfa'Safe Premium Wip'Anios Excel Tuffie 5

Dr. Schumacher ANIOS Laboratories

CE

Vernacare

ARTG

CE

1) United States Environmental Protection Agency 2) Australian Register of Therapeutic Goods 3) Virucidal against enveloped viruses

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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:

49650

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

A

B

48251

b. Install the lid on the water reservoir and push back the latch (C) on top of the lid to secure it.

C

D 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.

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Fitting the manifold 48103

1. On devices without the humidification system option, reinstall the manifold.

Fitting the drain plug

49643

1. On devices without the condensation management system, reinstall the drain plug (A) in the bottom of the heater well.

A

Fitting the condensation management system (if installed)

48276

1. On devices with the condensation management system, install a new collection bottle (A).

D E A

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