Nebu-tec OPTINEB-ir ON-100/2-2.4 MHz Operating Instructions Manual
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Nebu-tec OPTINEB-ir ON-100/2-2.4 MHz Operating Instructions Manual

Microprocessor controlled mobile ultrasonic nebuliser
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OPTINEB
Microprocessor Controlled • Mobile Ultrasonic Nebuliser
Microprocessor Controlled Mobile Ultrasonic Nebuliser
for Artificial Respiration (ventilation)
Unit Type
ON-100/2-2.4 MHz
Made in Germany/
Made in Germany
WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 1 of 33
®
Operating
Instructions
Operating Instructions
for physicians and authorized clinic personnel/
for physicians and authorized clinic personnel
-ir

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Summary of Contents for Nebu-tec OPTINEB-ir ON-100/2-2.4 MHz

  • Page 1 ® OPTINEB Microprocessor Controlled • Mobile Ultrasonic Nebuliser Microprocessor Controlled Mobile Ultrasonic Nebuliser Operating Instructions Operating Instructions for Artificial Respiration (ventilation) for physicians and authorized clinic personnel/ for physicians and authorized clinic personnel Unit Type ON-100/2-2.4 MHz Made in Germany/ Made in Germany WATSON LABORATORIES, INC.
  • Page 2 Manufacturer Kreuzfeldring 17 63820 Elsenfeld - GERMANY Tel.: (+49) (0)6022-610-620 Fax: (+49) (0)6022-649-812 e-mail: nebu-tec@t-online.de web: http://www.nebu-tec.de ® OPTINEB Microprocessor Controlled Mobile Ultrasonic Nebuliser Operating Instructions Type: ON-100/2-2.4 MHz Made in Germany Dear Patient, With the mobile Ultrasonic Nebuliser OPTINEB -ir, you have received an ®...

  • Page 3: Table Of Contents

    Content Table of Contents 1.0  Symbols  2.0  Safety Instructions  3.0  Intended use  3.1  Function during ventilation  3.2  Aerosol spectrum (particle size)  4.0  The most important component parts of your OPTINEB ® -ir ultrasonic nebuliser  5.0  Initial operation of your OPTINEB -ir ultrasonic nebuliser for ventilation ...

  • Page 4: Symbols

    Symbols 1.0 Symbols Attention, see instructions Protection class II device Applied part, type B Device class AP 1275 2.0 Safety Instructions These operating instructions must be fully understood and observed when using this device. In all cases the operator is liable for the safe operation of the device if it is used by a third party or not used according to the instructions.
  • Page 5 In such cases, send the device to the manufacturer or to an authorized NEBU-TEC dealer for inspection and repair. 5. Keep the mains cable away from heated surfaces.

  • Page 6: Intended Use

    Intended Use 10. Replace the contact fluid after 24 hours at the latest. 11. Do not use cleaning solutions, vinegar, hot or even boiling water, etc. to clean the housing, contact fluid chamber, quartz or sensors. 12. Do alkaline aqueous-based cleaning solutions, aromatic...

  • Page 7: Aerosol Spectrum (Particle Size)

    Aerosol Spectrum 3.2 Aerosol spectrum (particle size) The particle size (MMAD/mass median aerodynamic diameter in μm) of the aerosol can be determined by using different baffle plates. Baffle plate 1 (ON-117G) green color MMAD 2.3 μm alveolar deposition Baffle plate 2 (ON-117B) blue color MMAD 3.2 μm alveolar deposition Baffle plate 3 (ON-117R) red color MMAD 3.8 μm bronchial deposition...

  • Page 8: The Most Important Component Parts Of Your Optineb

    Component parts ® -ir ultrasonic 4.0 The most important component parts of your OPTINEB nebulizer WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 8 of 33...
  • Page 9 Component parts OPTINEB®-ir ultrasonic nebulizer (Item ON-100/2 – 2.4 MHz) A2.1 Angle adapter for respirator 22ID/22AD (Item ON-B-114) A2.11 Adapter 22AD 9-11 mmAD (Item ON-B-112) A2.12 Adapter 22AD 9-13 mmAD (Item ON-B-113) A2.13 Adapter 22AD 15AD (Item ON-B-121) A3.1 Adapter for respirator (Item ON-B-115) A3.12 Adapter 22ID 9-11 mmAD (Item ON-B-110) A3.13 Adapter 22ID 9-13 mmAD (Item ON-B-111) A3.14 Adapter 22ID 15AD (Item ON-B-122)

  • Page 10: Initial Operation Of Your Optineb

    Initial operation ® 5.0 Initial operation of your OPTINEB -ir ultrasonic nebulizer for ventilation Preparing the ultrasonic nebuliser. 5.01 Ensure first that the Sensor ® -ir [A1] ultrasonic nebulizer is OPTINEB not connected to a power source. Remove any power supply by pulling out the connection cables from the socket.
  • Page 11 Component parts Now the sterile medication cup that was inserted in Step 5.02 is firmly connected with the top piece and the ultrasonic nebulizer to form a closed system. 5.06 Now adapt the angle piece for ventilation [A2.1] with the upper opening of the top piece.
  • Page 12 Initial operation ® 5.10 Use of OPTINEB -ir in the ventilation system with climate-control filter Can only be used with ventilators with the medication nebulization option. If you are using climate-control filters or an active humidification for your ventilation, please proceed as specified below. Insert the filter housing [A17] including an inserted filter membrane [A9.1] into the top piece [A4] on the side.
  • Page 13 Initial operation Unscrew the white Luer/Lock plug [A7] place it on the parking space intended for it [A5]. Connect the control line for mechanical nebulization [A22] to the adapter of your ventilator intended for this purpose and with the Luer/Lock/connection of the OPTINEB ®...

  • Page 14: Power Supply Of The Ultrasonic Nebuliser Optineb

    Power Supply ® 6.0 Power supply of the ultrasonic nebulizer OPTINEB -ir. The ultrasonic nebulizer can be operated with three different types of power source: Alternating current 110/230 VAC, direct current 12 VDC (motor vehicles), or by battery. 6.1 Alternating current operation Connect the AC power supply [A17] to the device, and plug the other end into the power outlet (110 or 220/230 Volt).
  • Page 15 EMC guidelines, only the original power supply [A17] may be used. NOTE Drop off defective battery cells for disposal at battery disposal sites or return them to NEBU-TEC GmbH. WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 15 of 33...

  • Page 16: The Meaning Of The Key Assignment And The Display Screen Of The Optineb

    Key Assignment 7.0 The meaning of the key assignment and the display screen of the -ir ultrasonic nebulizer ® OPTINEB ® When connecting the OPTINEB -ir to the power supply, the last used or pre-set inhalation or nebulization program appears on the display [A12] whereby each program is briefly (for approx.

  • Page 17: Programme Selection And Operation Of The Optineb

    Display Indications Display indications [A12] (LB) Empty battery (LH) Contact fluid missing/incorrect contact fluid poured in (SA) Contaminants or saline fluid poured in (tap water, saline solution, mineral water, etc.) (PA) Pause (En) End ® 8.0 Program selection and operation of the OPTINEB -ir ultra-sonic nebulizer for ventilation With OPTINEB...
  • Page 18 Programmes -ir 2.4 MHz program ® 8.2 Description of the ultrasonic nebulizer OPTINEB The following statements apply for programs P1 to P5:  The main function of the keys “Start/Stop” and “On/Off” are identical.  In program 6 (P6), the “Start/Stop” key is neutralized. ...
  • Page 19 Programmes ® The OPTINEB -ir initially generates aerosol intermittently in order to prevent surge effects and then works continuously. The intermittent period is pre-set to 2 minutes. The user is not able to change the program parameters. In order to interrupt aerosol production, please press the “Start/Stop” [A15] key. By again pressing the “Start/Stop”...
  • Page 20 Programmes 8.2.6 Features of the sixth program (P6) The program was designed for ventilation purposes. The active output intervals and the pause times are adjustable using the keypad. (See Point 8.3 Individual programming of Program 6 with the OPTINEB ® -ir) ®...
  • Page 21 Programmes The time of the active phase may not be greater/longer than the time of the passive phase, or the active phase of the nebulization may not be entered as greater than the time for the pause phase. When trying to adhere to this rule, the ®...

  • Page 22: Use Of The Optineb

    Volume-controlled mode ® The OPTINEB -ir ultrasonic nebuliser switches off after reaching a remaining quantity of approx. 0.5 ml automatically. En (=End) appears in the display. ® You can restart OPTINEB -ir only after refilling approx. 2 ml of medication solution.

  • Page 23: Cleaning Instructions For Optineb

    Cleaning ® 10.0 Cleaning instructions for OPTINEB The OPTINEB ® -ir ultrasonic nebulizer must be cleaned after use with one-time daily use or after the last inhalation in case of multiple daily inhalations. Cleaning must in general always be carried out when changing patients. By paying careful attention to the steps listed below, output can be maximized and the life of your ultrasonic nebulizer can be extended.

  • Page 24: Cleaning Of The OptinebĀ®-Ir Ultrasonic Nebuliser

    Cleaning IMPORTANT INFORMATION Nebuliser top piece [A4] with sealing ring and baffle plate(s), exhalation part [A3], filter housing [A8/A9] and Luer/Lock screw cap [A7]should be replaced with multiple daily uses after 3 months. With one-time daily inhalation, the aforementioned items must be replaced according to wear and hygienic state. 10.2 Cleaning of the OPTINEB®-ir ultrasonic nebulizer.

  • Page 25: Servicing

    Micro-deformed 12.0 Servicing The OPTINEB®-ir ultrasonic nebulizer should be serviced every 2 years. Servicing may only be performed by NEBU-TEC GmbH or a specifically authorized or qualified NEBU-TEC dealer. WARNING Do not open the housing. Non-observance results in the warranty being voided.

  • Page 26: Information On Trouble-Shooting

    Trouble- shooting 13.0 Information on trouble-shooting If you believe that your USN is not properly functioning, please take the time to check or resolve possible defects before making a complaint about the device. Symptoms Possible causes Trouble-shooting Display indication 1. Power supply defect 1.
  • Page 27 Trouble- shooting Lower Aerosol 1. Used damaged 1. Replace medication output medication cup. cup. (remaining quantity is too high) 2. Contact fluid level in 2. Fill contact fluid contact fluid reservoir reservoir with 45 ml too high/low. distilled water (use measuring with markings).
  • Page 28 Technical Data 14.0 Technical data of the OPTINEB®-ir ultrasonic nebulizer Size ................... 98 x 66 x 105 mm Weight of basic device ................... 280 g Power supply type ..........Power supply unit 110/230 VAC ............12 V motor vehicle cigarette lighter adapter ......................

  • Page 29: Accessories

    Accessories ON-118 ..... Measuring cup ................1 ON-122 ..... Special mask > Children – size 1 with expiratory valve .... 1 Children /0–1 kg body weight ON-123 ..... Special mask > Children – size 2 with expiratory valve .... 1 Children /1–8 kg body weight ON-124 .....

  • Page 30: Compatibility

    We provide you with a warranty of 24 months from the date of purchase for the ® -ir ultrasonic nebulizer. OPTINEB 18.0 Declaration of conformity NEBU-TEC med. Product Eke Kern GmbH Manufacturer: Kreuzfeldring 17 63820 Elsenfeld - GERMANY Phone: +49(0)6022-610 62-0...

  • Page 31: Garantiekarte Zum Abtrennen/Warranty Card (Tear-Off Card)

    Warranty Card 19.0 Garantiekarte zum Abtrennen/Warranty Card (tear-off card) Garantiekarte Warranty Card Typ/Type: VN-100/4-2,4 MHz Geratenummer/Serial Number: Kaufdatum/Purchase Date: Benutzer, Handler/User, Dealer Name: ....................... Strase, Adresse/Street, Address: ................................PLZ, Ort/Zip Code, Town: ..................................Land/Country: ....................Stempel/Stamp: WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 31 of 33...
  • Page 32 WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 32 of 33...
  • Page 33 I, William L. Chisholm, declare that:  I am fluent in both German and English. To the best of my knowledge and belief, the attached document is a true and correct translation of a user manual for OPTINEB®‐ir from German to English.  I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements  were made with knowledge that willful false statements and the like so made are punishable by fine or  imprisonment, or both, under 18 U.S.C. 1001.  2017-06-15 Date:   ______ ___________________  NAME OF TRANSLATOR  WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 33 of 33...

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