Nebu-tec OPTINEB-ir ON-100/2-2.4 MHz User manual

OPTINEB®-ir
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
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Manufacturer
2
Kreuzfeldring 17
63820 Elsenfeld - GERMANY
Tel.: (+49) (0)6022-610-620
Fax: (+49) (0)6022-649-812
e-mail: [email protected]
web: http://www.nebu-tec.de
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.
WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1006, p. 2 of 33

Content
3
GERMAN
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
6.0Power supply of the ultrasonic nebuliser OPTINEB®-ir.
6.1Alternating current operation
6.2Direct current outlet
6.3Battery operation
7.0The meaning of the key assignment and the display screen of the
OPTINEB®-ir ultrasonic nebuliser
8.0Programme selection and operation of the OPTINEB®-ir ultra-sonic
nebuliser for ventilation
8.1Programming mode only for authorised persons.
8.2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)
8.3Individual programming of Programme 6 with the OPTINEB®-ir
8.4Volume-controlled mode
9.0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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Symbols
4
GERMAN
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. Important
information is highlighted by the following terms:
WARNING
Important safety information on hazards that can lead to bodily harm.
ATTENTION
Important information on operating procedures that can cause device
malfunctions.
CAUTION
Information that prevents product damage.
NOTE
Information that you should be especially aware of.
[ For component parts, see Sketch 4.0 ]
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Safety Notes
5
GERMAN
Please read through the instructions for use carefully before initial operation.
Keep these operating instructions in a safe place.
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.
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
6
GERMAN
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.
NOTE
The device may heat up on the underside in the case of extended use.
3.0 Intended use
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.
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
7
GERMAN
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
Baffle plate 4 (ON-117Y) yellow color MMAD 4.5 μm tracheal deposition
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Component
parts
8
GERMAN
4.0 The most important component parts of your OPTINEB®-ir ultrasonic
nebulizer
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Component
parts
9
GERMAN
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
10
GERMAN
5.0 Initial operation of your OPTINEB®-ir ultrasonic nebulizer for
ventilation
Preparing the ultrasonic nebuliser.
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.
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.
5.03 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.
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.
5.05 Now place the top piece [A4] on the
ultrasonic nebulizer and turn it once on its
own axis until a light click can be heard. Do
not force when turning it.
Sensor
Sensor
Sensor
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Component
parts
11
GERMAN
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.
5.07 Now insert the adapter for ventilation [A3.1] into the opening outgoing to
the side of the top piece using light pressure.
5.08 Now connect the Y-adapter [A8] onto the angle piece for ventilation [A2.1].
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.
Inspiratory
flo
w
Y-piece
Filter
Expiration
Inspiration
Patient
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Initial operation
12
GERMAN
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).
(sterile hose system incl. control line, angle piece, 60cm creased tube and T-
piece) [A19].
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.
Filter Expiration
Inspiration
Patient
Mechanical nebulisation A22 control line
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Initial operation
13
GERMAN
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).
(sterile hose system incl. control line, angle piece, 60cm creased tube and T-
piece) [A19].
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.
Filter
Expiration
Inspiration
Patient
Mechanical nebulisation A22 control line
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Power Supply
14
GERMAN
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).
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.
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.
6.3 Battery operation
Nickel-cadmium battery [A16] or
Nickel-metal hybrid battery [A16]
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Power supply
15
GERMAN
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.
When the battery charge is 100%, operation of the ultrasonic nebulizer
OPTINEB®-ir of approx. 40 min. is possible.
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.
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.
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
16
GERMAN
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 nebulizer, press the
“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
Infrared sensor
A13
Infrared sensor
A13
Multifunction
lamp A17
On/Off
Start/Stop
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Display
Indications
17
GERMAN
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®-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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Programmes
18
GERMAN
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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Programmes
19
GERMAN
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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Programmes
20
GERMAN
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)
8.3 Individual programming of Program 6 with the OPTINEB®-ir
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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