Dräger Isolette 8000 plus Instructions For Use Manual
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Dräger Isolette 8000 plus Instructions For Use Manual

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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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Summary of Contents for Dräger Isolette 8000 plus

  • Page 1 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...
  • Page 2 This page has been left blank intentionally. Supplement to the instructions for use Isolette 8000 plus...

  • Page 3: Table Of Contents

    Contents Contents Isolette 8000 plus Incubator Information about this document ............Trademarks..................Reprocessing.................... Safety instructions ................Safety information................Information on reprocessing ............Classifications for reprocessing ............Before reprocessing................ Validated reprocessing procedures ..........Other agents and reprocessing procedures ........After reprocessing................

  • Page 4: Information About This Document

    Information about this document 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...

  • Page 5: Reprocessing

    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.. Supplement to the instructions for use Isolette 8000 plus...

  • Page 6: Information On Reprocessing

    ► 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.

  • Page 7: Before Reprocessing

    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). Supplement to the instructions for use Isolette 8000 plus...
  • Page 8 ► 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 9 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 10 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 11 ► 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 12 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. Supplement to the instructions for use Isolette 8000 plus...

  • Page 13: Validated Reprocessing Procedures

    – Removable parts of the main system Surface disinfection using the following surface disinfectant is suitable for the device and all components: Surface disinfec- Manufacturer Concentration Contact time tant Dizmozon plus BODE Chemie 1.6 % 15 min Supplement to the instructions for use Isolette 8000 plus...
  • Page 14 ► 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 15 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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 16 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 Supplement to the instructions for use Isolette 8000 plus...

  • Page 17: Other Agents And Reprocessing Procedures

    All further information on storage and transport included in the accompanying documents must be observed. Other agents and reprocessing procedures 2.7.1 Disinfectants Use nationally approved disinfectants suitable for the respective reprocessing process and the intended application. Supplement to the instructions for use Isolette 8000 plus...
  • Page 18 Dr. Schum- acher Surfa'Safe Premium ANIOS Labo- ratories Wip'Anios Excel Tuffie 5 Vernacare ARTG 1) United States Environmental Protection Agency 2) Australian Register of Therapeutic Goods 3) Virucidal against enveloped viruses Supplement to the instructions for use Isolette 8000 plus...

  • Page 19: After Reprocessing

    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. Supplement to the instructions for use Isolette 8000 plus...
  • Page 20 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). Supplement to the instructions for use Isolette 8000 plus...
  • Page 21 3. Turn the plug (C) at the bottom of the heater well 90 degrees clockwise. 4. Install the clamp (D) on the condensation management hose. 5. Connect the condensation management hose (E) to the collection bottle located underneath the left side of the incubator. Supplement to the instructions for use Isolette 8000 plus...
  • Page 22 Installing the upper cover when the hood is down may result in damage to the upper cover and/or jamming of the hood in place. ► Ensure that the hood is raised before attempting to install the upper cover. Supplement to the instructions for use Isolette 8000 plus...
  • Page 23 Fitting the iris port sleeves, hose grommets, and hand port gaskets (if installed) 1. If equipped with the optional iris ports on the side access panels, install the new iris port sleeves: Supplement to the instructions for use Isolette 8000 plus...
  • Page 24 Fold back, and slip the larger elastic band over the outer ring (A) of the port housing. c. To close, rotate the outer ring (A). If properly installed, the sleeve opens again when rotation is reversed. Supplement to the instructions for use Isolette 8000 plus...
  • Page 25 Fitting the air inlet filter 1. Install the air inlet filter into the air inlet filter chamber located under the shell assembly on the rear of the device. 2. Install the air inlet filter cover. Supplement to the instructions for use Isolette 8000 plus...
  • Page 26 – The device has been assembled and prepared so that it is ready for operation. Procedure: 1. Check the operational readiness; see chapter "Getting started" in the instructions for use for the main device. Supplement to the instructions for use Isolette 8000 plus...

  • Page 27: Index

    Disassembly..... . . 10 Water reservoir ..... 11 Supplement to the instructions for use Isolette 8000 plus...
  • Page 28 Reprocessing ..... . 14 Validated reprocessing procedures ..13 Supplement to the instructions for use Isolette 8000 plus...
  • Page 29 Index Supplement to the instructions for use Isolette 8000 plus...
  • Page 30 Manufacturer European representative 制造商 Draeger Medical Systems, Inc. Drägerwerk AG & Co. KGaA 德尔格制造股份两合公司 3135 Quarry Road Draegerwerk AG & Co. KGaA Moislinger Alle 53 – 55 Telford, PA 18969 Moislinger Allee 53 – 55 23542 Lübeck 23542 Luebeck Germany (215) 721-5400 +49 451 8 82-0 德国...

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