`
`Microprocessor Controlled • Mobile Ultrasonic Nebuliser
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`Microprocessor Controlled Mobile Ultrasonic Nebuliser
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` OPTINEB®-ir
`Operating
`Instructions
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`Operating Instructions
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`for Artificial Respiration (ventilation)
`for physicians and authorized clinic personnel/
`for physicians and authorized clinic personnel
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`Unit Type
`ON-100/2-2.4 MHz
`Made in Germany/
`Made in Germany
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 1 of 33
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`OPTINEB®-ir
`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
`inhalation device that has been adjusted extremely precisely in a conditioned room.
`In order to ensure a constant operation of the equipment we ask you to carefully
`read the operating manual and to follow the instructions before you put the device
`into service.
`We wish you every success for your treatment with the OPTINEB®-ir
`
`OPTINEB®-ir
`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 inhalation
`device that has been adjusted extremely precisely in a conditioned room.
`In order to ensure a constant operation of the equipment we ask you to carefully
`read the operating manual and to follow the instructions before you put the device
`into service.
`We wish you every success for your treatment with the OPTINEB®-ir.
`
`Manufacturer
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`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
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 2 of 33
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`Content
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`Table of Contents
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`1.0
`2.0
`3.0
`3.1
`3.2
`4.0
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`5.0
`6.0
`6.1
`6.2
`6.3
`7.0
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`8.0
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`8.1
`8.2
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`8.3
`8.4
`9.0
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`Symbols
`Safety Instructions
`Intended use
`Function during ventilation
`Aerosol spectrum (particle size)
`The most important component parts of your OPTINEB®-ir ultrasonic
`nebuliser
`Initial operation of your OPTINEB®-ir ultrasonic nebuliser for ventilation
`Power supply of the ultrasonic nebuliser OPTINEB®-ir.
`Alternating current operation
`Direct current outlet
`Battery operation
`The meaning of the key assignment and the display screen of the
`OPTINEB®-ir ultrasonic nebuliser
`Programme selection and operation of the OPTINEB®-ir ultra-sonic
`nebuliser for ventilation
`Programming mode only for authorised persons.
`Description of the ultrasonic nebuliser OPTINEB®-ir 2.4 MHz programme
`8.2.1 Features of the first programme (P1)
`8.2.2 Features of the second programme (P2)
`8.2.3 Features of the third programme (P3)
`8.2.4 Features of the fourth programme (P4)
`8.2.5 Features of the fifth programme (P5)
`8.2.6 Features of the sixth programme (P6)
`Individual programming of Programme 6 with the OPTINEB®-ir
`Volume-controlled mode
`Use of the OPTINEB®-ir ultrasonic nebuliser with a non-invasive ventilation
`mask.
`10.0 Cleaning instructions for OPTINEB®-ir
`10.1 Cleaning and replacement intervals of autoclaved plastic parts
`10.2 Cleaning of the OPTINEB®-ir ultrasonic nebuliser.
`11.0 Replacement interval of medication cup and filter membrane
`12.0 Servicing
`13.0
`Information on trouble-shooting
`14.0 Technical data of the OPTINEB®-ir ultrasonic nebuliser.
`15.0 Accessories
`16.0 Compatibility
`17.0 Warranty
`18.0 Declaration of conformity
`19.0 Garantiekarte zum Abtrennen/Warranty Card (tear-off card)
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 3 of 33
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`Symbols
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`1.0 Symbols
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` Attention, see instructions
` Protection class II device
`Applied part, type B
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`Device class AP
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`1275
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`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. Important
`information is highlighted by the following terms:
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`WARNING
`Important safety information on hazards that can lead to bodily harm.
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`ATTENTION
`Important information on operating procedures that can cause device
`malfunctions.
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`CAUTION
`Information that prevents product damage.
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`NOTE
`Information that you should be especially aware of.
`[ For component parts, see Sketch 4.0 ]
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`Safety Notes
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`Please read through the instructions for use carefully before initial operation.
`Keep these operating instructions in a safe place.
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`WARNING
`1. Pull out the mains plug after each use.
`2. Do not use the device while bathing.
`3. The device is to be set up so that it cannot fall into water.
`4. Do not immerse the device into water or any other fluid.
`5. Do not use the device if it has fallen into water, and immediately pull out the
`mains plug.
`6. Do not use the device in the rain.
`7. Do not use the device near easily inflammable materials.
`8. Never place your hand or finger in the medication reservoir while the device is
`operating.
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`ATTENTION
`1. An operating electrical device should never be left unattended.
`2. You must be particularly careful when the device is used by or near children
`or seriously ill persons.
`3. Only use the device for its intended purpose, as specified in these operating
`instructions. Under no circumstances should accessory parts be used that are
`not recommended by the manufacturer.
`4. Never operate this device in the following cases:
`a) if the mains cable or plug is damaged
`b) if the device is not properly functioning
`c) if the device was dropped or was damaged
`d) if the device fell into water. 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.
`6. Place the device on a level and stable surface in a way that no air openings
`are blocked.
`7. Do not use the device while sleeping.
`8. Never clean the ultrasonic nebulizer in the dishwasher or microwave (never
`expose the base unit to direct microwave radiation).
`9. While cleaning the contact fluid chamber of the OPTINEB®-ir, prevent
`moisture from being able to penetrate into the housing.
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`Intended Use
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`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 not use alkaline aqueous-based cleaning solutions, aromatic
`hydrocarbons, ammonia or amines to clean the autoclavable plastic parts.
`Instead, use cleaners based on aliphatically saturated hydrocarbons, alcohol,
`diluted mineral acids, neutral or acidic saline solutions.
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`NOTE
`The device may heat up on the underside in the case of extended use.
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`Intended use
`3.0
`Your OPTINEB®-ir ultrasonic nebulizer is a portable device that is intended to
`produce aerosols in various particle sizes by using different baffle plates (see
`Section 3.2). This ensures an optimal and identifiable deposition of your
`medication.
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`3.1 Function during ventilation
`The OPTINEB®-ir ultrasonic nebulizer can be used with all ventilators.
`It is only permissible to install the OPTINEB®-ir ultrasonic nebulizer into your
`ventilation system as specified in the operating instructions.
`If the OPTINEB®-ir ultrasonic nebulizer is in operation, aerosol production takes
`place.
`The fog generated is transported by the inspiratory flow to the patient, or is
`introduced via a T-piece by means of the control through the line for medication
`nebulization only during the inspiration phase directly at the tube body. (see
`sections 5.09/5.10/5.11)
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`Aerosol
`Spectrum
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`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.
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`Baffle plate 1 (ON-117G) green color MMAD 2.3 μm alveolar deposition
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`Baffle plate 2 (ON-117B) blue color MMAD 3.2 μm alveolar deposition
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`Baffle plate 3 (ON-117R) red color
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`Baffle plate 4 (ON-117Y) yellow color MMAD 4.5 μm tracheal deposition
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` MMAD 3.8 μm bronchial deposition
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`Component
`parts
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`4.0 The most important component parts of your OPTINEB®-ir ultrasonic
`nebulizer
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`Component
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`A1 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)
`A4 Nebuliser upper part (Item ON-103) with sealing ring (Item ON-110), baffle
`plate (Item ON-117B/G/R/Y) and screw cap by Luer/Lock (Item ON-116)
`A5
`parking space for Luer/Lock screw cap
`A6
`Luer/Lock connection
`A7
`Luer/Lock screw cap (Item ON-116)
`A8.2 Kinder silicon hose 10.5 cm (Item ON-B-108)
`A9
`Inhalation filter housing with valve and filter membrane (Item ON-101)
`A9.1 Filter membrane (Item ON-109)
`A10 Medication cup (Item ON-102)
`Sterile medication cup (Item ON-102S)
`A11 Multifunction lamp
`A12 Display screen
`A13
`Infrared sensor
`A14 On/Off switch
`A15 Start/Stop switch
`A16 Battery (Item ON-100A/ON-100HPA)
`A17 Power supply 110/230 VAC (Item ON-100N)
`A18 12 V motor vehicle cigarette lighter adapter (Item ON-100Z)
`A19 Aerosol inlet hose system close to patient (Item ON-B-199)
`A20 Extension hose 22AD/15ID (Item ON-B-123)
`A21 Children’s mask with exhalation valve size 1/2/3 (Item ON-122/123/124)
`A22 Luer/Lock hose for oxygen or control line for mechanical nebulization
`(Item ON-111)
`A23 Adapter for inspiratory flow (Item ON-B-119)
`A24 Adult Y-piece 22AD/14ID 22AD 22AD (Item ON-B-198)
`A25 Neonatal Y-piece 22AD/15ID 9-11 mm AD (Item ON-B-197)
`A26 Adapter for mask adaption 22 AD/22AD - 15 ID (Item ON-119)
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`Initial operation
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`5.0
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`GERMAN
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`Initial operation of your OPTINEB®-ir ultrasonic nebulizer for
`ventilation
`Preparing the ultrasonic nebuliser.
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`5.01 Ensure first that the
`OPTINEB®-ir [A1] ultrasonic nebulizer is
`not connected to a power source.
`Remove any power supply by pulling out
`the connection cables from the socket.
`(Reverse side of OPTINEB®-ir).
`5.02 Take the OPTINEB®-ir ultrasonic nebulizer and fill it with 45 ml of distilled
`or demineralized water.
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`Sensor
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`ATTENTION
`The use of other contact fluids (e.g. tap water, sterile water or saline solution) is
`strictly prohibited since this can lead to significant impairment of the performance
`of the device and even to complete malfunction.
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`5.03
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`Sensor
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`Insert a sterile medication cup [A10] with the
`tip facing downwards into the ultrasonic
`nebulizer. Bear in mind that the medication
`cup must be submerged in the contact fluid.
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`5.04 Now begin to assemble the autoclaved and
`therefore sterile plastic pieces. Begin with the top piece
`[A4]. Check whether the baffle plate is firmly seated in
`the housing, the sealing ring is in its guide and the white
`Luer/Lock plug is securely locked.
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`[A4] on
`5.05 Now place
`the
`top piece
`the
`ultrasonic nebulizer and turn it once on its
`own axis until a light click can be heard. Do
`not force when turning it.
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`Sensor
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`Component
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`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.
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`5.06 Now adapt the angle piece for ventilation [A2.1] with the upper opening of
`the top piece.
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`5.07 Now insert the adapter for ventilation [A3.1] into the opening outgoing to
`the side of the top piece using light pressure.
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`5.08 Now connect the Y-adapter [A8] onto the angle piece for ventilation [A2.1].
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`Y-piece
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`Inspiratory
`flow
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`5.09 Use of OPTINEB®-ir in the inspiration branch of the ventilation
`system
`Can be used with all ventilators.
`Now integrate the OPTINEB®-ir ultrasonic nebulizer into the inspiration branch of
`your ventilation system. To do this, connect the inspiration hose with the blue
`adapter for ventilation on the OPTINEB®-ir. Orient the outlet of the angle piece
`toward the patient, and connect with a Y-piece. This is then adapted to an elbow
`or with the tube. Orient the still free outlet of the Y-piece (away from the patient),
`and connect with the expiration hose.
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`Filter
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`Expiration
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`Inspiration
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`Patient
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`Initial operation
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`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.
`Unscrew the white Luer/Lock plug [A7] and place it on the parking space
`intended for it [A5]. Connect the control line for mechanical nebulization [A22]
`with the adapter of your ventilator intended for this purpose and with the
`Luer/Lock/connection [A6] of the OPTINEB®-ir ultrasonic nebulizer.
`Now connect the OPTINEB®-ir [A1] ultrasonic nebulizer by adaption with the
`hose system for the aerosol inlet close to the patient [A19] with the ventilator
`hose system (T-piece between climate-control filter and tube).
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`Filter
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`Expiration
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`Inspiration
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`Patient
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`Mechanical nebulisation A22 control line
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`(sterile hose system incl. control line, angle piece, 60cm creased tube and T-
`piece) [A19].
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`5.11 Use of OPTINEB®-ir in the ventilation system with coaxial hoses
`Can be used with ventilators with the medication nebulization option. If you
`are using coaxial hoses for your ventilation, please proceed as specified below.
`Insert the filter housing [A9] including an inserted filter membrane [A9.1] into the
`top piece [A4] on the side.
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`Initial operation
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`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®-ir ultrasonic nebulizer.
`A climate-control filter can be used at the inspiratory end of the coaxial hose in
`the direction of the patient.
`Now connect the OPTINEB®-ir [A1] ultrasonic nebulizer by adaption with the
`hose system for the aerosol inlet close to the patient [A19] with the ventilator
`hose system (T-piece between climate-control filter and tube).
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`Filter
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`Expiration
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`Inspiration
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`Patient
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`Mechanical nebulisation A22 control line
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`(sterile hose system incl. control line, angle piece, 60cm creased tube and T-
`piece) [A19].
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`IMPORTANT
`Use only sterile medication cups [A10] for use in the ventilator.
`When using the OPTINEB®-ir in the ventilation system, use only sterile
`accessories.
`Aerosols only come into contact with the autoclaved parts and not with the actual
`device.
`In order to protect your circle part from aerosol residue and your ventilator
`against damage, an end expiratory mechanical
`filter must be used
`(manufacturing company: Hudson, Pall, B+P, Tyco).
`Compatibility checks are available for the most widely-used ventilators.
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`Power Supply
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`6.0 Power supply of the ultrasonic nebulizer OPTINEB®-ir.
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`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.
`
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`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).
`
`NOTE for alternating current operation
`Do not use the device while bathing.
`The device is to be set up so that it cannot fall into water.
`Do not immerse the device into water or any other fluid.
`Do not use the device if it has fallen into water.
`Immediately pull out the mains plug.
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`6.2 Direct current outlet
`Connect the car adapter [A18] to the device, and plug the other end into the
`corresponding 12V-DC socket (cigarette lighter in motor vehicle, etc.).
`
`NOTE for direct current operation
`Do not use the device while bathing.
`The device is to be set up so that it cannot fall into water.
`Do not immerse the device into water or any other fluid.
`Do not use the device if it has fallen into water.
`Immediately pull out the plug from the car adapter.
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`6.3 Battery operation
`Nickel-cadmium battery [A16] or
`Nickel-metal hybrid battery [A16]
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`Power supply
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`6.3.1 The battery is charged through the power supply [A17]. For this, connect
`the plug of the power supply to the battery [A16]).
`6.3.2 The charging time for the battery is approx. 8–10 hours.
`6.3.3 Charging should never exceed 12 hours.
`6.3.4 Battery operation is not possible while the battery is charging.
`6.3.5 The battery must be disconnected from the power supply of the
`OPTINEB®-ir after charging.
`6.3.6 Connect the charged battery only for the duration of the inhalation with the
`OPTINEB®-ir.
`6.3.7 Please pull out the battery plug from the device after ending inhalation.
`6.3.8 Only after the display [A12] of the OPTINEB®-ir shows the letter
`combination (LB) may the battery be charged again.
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`
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`When the battery charge is 100%, operation of the ultrasonic nebulizer
`OPTINEB®-ir of approx. 40 min. is possible.
`
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`NOTE during battery operation
`Do not use the device while bathing.
`The device is to be set up so that it cannot fall into water.
`Do not immerse the device into water or any other fluid.
`Do not use the device if it has fallen into water.
`Immediately pull out the battery plug.
`
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`CAUTION
`In order to prevent damage to the ultrasonic nebulizer and ensure adherence to
`EMC guidelines, only the original power supply [A17] may be used.
`
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`NOTE
`Drop off defective battery cells for disposal at battery disposal sites or return
`them to NEBU-TEC GmbH.
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`Key Assignment
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`Infrared sensor
`Infrared sensor
`A13
`A13
`Multifunction
`lamp A17
`On/Off
`Start/Stop
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`7.0 The meaning of the key assignment and the display screen of the
`OPTINEB®-ir ultrasonic nebulizer
`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. 1 second) illuminated.
`
`7.0.1 To switch on
`the
`the nebulizer, press
`“On/Off” [A14] sensor key (multifunction
`lamp [A17] lights up yellow).
`7.0.2 To start aerosol production, press
`the
`“Start/Stop” [A15] key, nebulization starts
`(multifunction lamp lights up green).
`7.0.3 In order to interrupt operation, please press
`the “Start/Stop” [A15] key during the nebulization process. Aerosol
`production is stopped (multifunction lamp lights up yellow) and PA (pause)
`appears on the display.
`In order to restart nebulization, press the “Start/Stop” key [A15] again.
`The display changes from “PA” in the time mode, the multifunction lamp
`lights up green and nebulization is continued.
`Operation is ended when “En” (End) appears on the display. At the same
`time, an acoustic signal sounds when the device is switched off.
`The length of the nebulization time (output per minute) can be influenced
`by the respective nebulization program or the ventilation parameters set.
`7.0.4 After the end of inhalation, switch the device off “On/Off” [A14]
`
`NOTE
`The device is equipped with a multifunction lamp that displays the operation
`status:
`
`Multifunction lamp:
`Yellow light
`-
`Device ready for operation
`Green light
`-
`Device in operation
`Red light
`- Malfunction
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 16 of 33
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`Display
`Indications
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`Display indications [A12]
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`(LB) Empty battery
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`(LH) Contact fluid missing/incorrect contact fluid poured in
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`(SA) Contaminants or saline fluid poured in
`(tap water, saline solution, mineral water, etc.)
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`(PA) Pause
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`(En) End
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`8.0 Program selection and operation of the OPTINEB®-ir ultra-sonic
`nebulizer for ventilation
`With OPTINEB®-ir, 6 function programs are available:
`P 1 Not suitable
`P 2 Not suitable
`P 3 Volume-controlled inhalation with increasing output.
`P 4 Volume-controlled inhalation with constant output.
`P 5 Not suitable
`P 6
`Intermittent operating mode, auto mode: Active/Passive operation,
`volume-controlled mode.
`
`
`8.1 Programming mode only for authorized persons.
`1. Proceed as follows to change the program:
`2. Hold down both the “On/Off” and “Start/Stop” sensor keys.
`3. Hold down both keys and connect OPTINEB®-ir with the power source.
`4. Wait until the display starts to blink.
`5. Then release both keys. The previously set program is indicated.
`6. Move program selection down with the left key and up with the right key.
`7. Approx. 7 sec. after the last key confirmation, the displayed program is saved.
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 17 of 33
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`8.2 Description of the ultrasonic nebulizer OPTINEB®-ir 2.4 MHz program
`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.
`
` The selection of the program is described in Point “8.1 Programming mode
`only for authorized persons”
`
`
`8.2.1 Features of the first program (P1)
`Program 1 was developed for the nebulization of special medications.
`Non-adjustable nebulization time: max. 12 minutes. Time indication on the
`display runs from “0” going forward until the pre-set time is reached. The aerosol
`is intermittently generated (no continuous aerosol production). After expiry of the
`pre-set time, the program is ended.
`
`8.2.2 Features of the second program (P2)
`Program 2 was developed for the nebulization of special medications.
`Non-adjustable nebulization time: max. 12 minutes.
`Time indication on the display runs from “0” going forward until the pre-set time is
`reached. The aerosol
`is
`intermittently generated (no continuous aerosol
`production). After expiry of the pre-set time, the program is ended. The user is
`not able to change the program parameters.
`
`8.2.3 Features of the third program (P3)
`No fixed nebulization time. The device is volume-controlled (remaining quantity
`recognition) and produces aerosol until the medication has been nebulized. The
`OPTINEB®-ir ultrasonic nebulizer switches off automatically after reaching a
`remaining quantity of approx. 0.5 ml. The inhalation time may differ in length and
`results from the set ventilation parameters, the respiratory rate and the depth of
`respiration
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 18 of 33
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`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” [A15] key, you can re-activate aerosol
`production.
`
`
`ATTENTION
`Please note the maximum fill level of the medication to be nebulized. This may
`not be greater than 7.5 ml to ensure continuous aerosol production.
`
`
`8.2.4 Features of the fourth program (P4)
`Corresponds to Program P3 but without the initial intermittent time period. The
`user is not able to change the program parameters.
`
`
`8.2.5 Features of the fifth program (P5)
`Program P5 corresponds to the OPTINEB in the conventional version with the
`following features:
` Flexibly adjustable inhalation time. Preference settings 1 to 15 minutes.
` After expiry of the set time, the program is ended.
` The user can re-program the inhalation time within the pre-set range (see
`instruction manual for patients).
`
`
`
`Setting the inhalation time (timer setting)
`Simultaneously press both sensor keys: Display flashes
`Press the left “Start/Stop” [A15] key:
`Adjust value down.
`Press the right “On/Off” [A14] key:
`Adjust value up.
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 19 of 33
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`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)
`
`Individual programming of Program 6 with the OPTINEB®-ir
`8.3
`In order to program Program 6 in an individually customized way, please proceed
`as follows:
`Select Program 6 as described in Point 8.1.
`If you have selected Program 6, hold down both the (“Start/Stop” and the
`“On/Off”) key simultaneously for approx. 2 seconds until the display flashes.
`The number now flashing indicates the operation duration in seconds for the
`active phase (nebulization phase). Set the desired time by navigating with the
`(“Start/Stop” and “On/Off”) keys. Once the desired time has been set, let the
`OPTINEB®-ir stand for approx. 5 seconds without pressing any keys. Then the
`set time will be automatically saved. Now the active phase is set.
`
`In order to now set the passive phase, please perform the same steps.
`Hold down both the (“Start/Stop” and the “On/Off”) key simultaneously for
`approx. 2 seconds until the display flashes. Now you will see the previously set
`time of the active phase. Navigate with the “On/Off” key upwards until the
`number 15 appears. Press the “On/Off” key again and it shows “PA” in the
`display. Now you are in the parameter settings of the Pause phase. By further
`navigating with the “On/Off” key, you can also set the time of the Pause phase
`in seconds. Once the desired time has been set, let the OPTINEB®-ir stand for
`approx. 5 seconds without pressing any keys. Then the set time will be
`automatically saved.
`Now the passive phase is set.
`By pressing the “Start/Stop” key, the OPTINEB®-ir now starts to nebulize in the
`active/passive phase.
`
`IMPORTANT
`Please note the following details for custom programming of the sixth program:
`
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 20 of 33
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`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
`OPTINEB®-ir synchronizes the entries automatically to the value last entered.
`
`Examples:
`You first enter 8 seconds for the active phase and then 4 seconds for the passive
`phase. Now the OPTINEB®-ir synchronizes the active phase to 4 seconds, as
`the passive phase was the last to be set.
`If you first set the passive phase to 8 seconds and then the active phase to
`10 seconds, the OPTINEB®-ir synchronizes the passive phase to 10 seconds
`since the active phase was last set in this case.
`
`IMPORTANT
`Explanation using an additional example:
`If you, for example, set the active phase to 10 seconds and the passive phase to
`0, the seconds of the active phase are automatically converted to minutes – in
`this case 10 minutes. The OPTINEB®-ir
`then nebulizes
`for 10 minutes
`continuously.
`
`In order to ensure the nebulization in an active/passive phase, two values must
`always be set (active/passive value).
`
`Please also note the following:
`The user of the device must ensure that the OPTINEB®-ir is connected as per
`our instruction manual.
`The user of the device must adhere to the relevant recommendations of the
`manufacturer of the ventilation machine with regard to the administration
`of aerosols during ventilation.
`
`NOTE
`In program 6 (P6), the “Start/Stop” key is neutralized.
`
`
`8.4 Volume-controlled mode
`The device is volume-controlled (remaining quantity recognition) and produces
`aerosol until the medication has been nebulized.
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 21 of 33
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`Volume-controlled mode
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`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.
`The nebulization time may differ in length and results from the set ventilation
`parameters.
`
`
`NOTE
`The remaining quantity left in the medication cup depends on the selected
`program:
`– approx. 0.5–1.5 ml remaining quantity
`P1
`– approx. 0.5–1.5 ml remaining quantity
`P2
`P3/P4/P5/P6 – approx. 0.5 ml remaining quantity
`
`ATTENTION
`Please note the maximum fill level of the medication to be nebulized. This may
`not be greater than 7.5 ml to ensure continuous aerosol production.
`
`
`9.0 Use of the OPTINEB®-ir ultrasonic nebulizer with a non-invasive
`ventilation mask.
`Connect extension hose [A20] and mask [A21] with OPTINEB®-ir.
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 22 of 33
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`Cleaning
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`10.0 Cleaning instructions for OPTINEB®-ir
`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.
`
`WARNING
`Always disconnect the ultrasonic nebulizer from the power supply before
`cleaning.
`
`Chemical resistance of the plastic used:
`to saturated aliphatic
`The plastic which we use has good resistance
`hydrocarbons, alcohols, diluted mineral acids, and neutral and acidic saline
`solutions.
`The plastic which we use is not resistant to aromatic hydrocarbons, ammonia,
`amines or alkaline aqueous solutions.
`
`Temperature resistance of the plastic used:
`The plastic which we use is temperature-resistant up to 134°C.
`
`Sterilization procedure:
`The following sterilization procedure can be applied with the plastic which we
`use:
` Ethylene oxide gas
` Superheated steam
` Hot air
` High-energy radiation (gamma and electron radiation)
`
`10.1 Cleaning and replacement intervals of autoclaved plastic parts
`Unscrew the nebulizer top piece (anti-clockwise) from the ultrasonic nebulizer.
`Remove the medication cup [A10] (disposable item). Please also unscrew the
`white Luer/Lock plug from the top piece (this plug cannot be autoclaved). Open
`the filter housing and remove the inserted filter membrane [A9.1] (disposable
`item). Now you can clean the plastic parts. Please note the aforementioned
`characteristics of the plastic (chemical resistance, temperature resistance,
`sterilization procedure).
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`WATSON LABORATORIES,
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