DECLARATION OF NATHANIEL E FRANK-WHITE
`
`1.
`
`I am a Records Request Processor at the Internet Archive. I make this declaration
`of my own personal knowledge.
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). The date indicated by an extended URL applies
`to a preserved instance of a file for a given URL, but not necessarily to any other
`files linked therein. Thus, in the case of a page constituted by a primary HTML file
`and other separate files (e.g., files with images, audio, multimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates.
`
`IPR2021-00406
`United Therapeutics EX2106
`
`

`

`6. Attached hereto as Exhibit B are true and accurate copies of the Internet Archive's
`records of the archived files for the URLs and the dates specified in the attached
`coversheet of each file.
`
`7.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE: ________________________
`
`________________________
`Nathaniel E Frank-White
`
`April 5, 2022
`
`Page 2
`
`

`

`EXHIBIT B
`
`EXHIBIT B
`
`Page 3
`
`

`

`https://web.archive.org/web/20041028003736/http:/www.schillmedical.co.uk:80/infracontrol%20engl3
`.pdf
`
`Page 4
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 1
`
`multisonic®
`infraControl
`
`Inhaling with ultrasonic
`
`Instructions for Use
`
`Page 5
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 2
`
`Overview of inhalation unit
`
`Exhalation valve
`(light blue)
`Inhalation valve
`(dark blue)
`
`Baffle plate
`
`Sealing ring
`
`Socket
`12 V (DC)
`Stopper
`for
`socket
`
`Plug-in mains supply unit MN 81200
`
`Mouthpiece
`
`Nebuliser head
`
`Plug 12 V DC
`(on supply unit
`and rechargeable
`battery pack)
`
`Rechargeable battery pack
`(depending on design)
`
`Function display
`(green, yellow)
`Charging status
`display (yellow)
`
`Carrying case
`(depending on design)
`
`Medicine chamber
`
`Function display
`
`ON/OFF switch
`
`Hand unit MN 81100
`
`Page 6
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 3
`
`Table of Contents
`
`Overview of inhalation unit
`
`Introduction and general information
`
`Starting the unit for the first time
`
`Hygiene: Cleaning, disinfection and
`sterilization
`
`Use of the rechargeable battery pack
`
`Trouble shooting
`
`Information on medicines
`
`Spare parts/consumables
`
`Optional accessories
`
`Service information and guarantee
`conditions
`
`Explanation of symbols
`
`Technical data and classification
`
`2
`
`4
`
`9
`
`15
`
`20
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`3
`
`Page 7
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 4
`
`Dear Patient
`
`The multisonic® infraControl is a powerful ultra-
`sound inhalation unit for preventative and thera-
`peutic deep inhalation that reflects the latest sci-
`entific findings in this area.
`However, the unit has not been designed for life-
`saving emergency treatment.
`The multisonic® infraControl can be used at home,
`whilst travelling and in clinics thanks to its univer-
`sal voltage supply options (mains or rechargeable
`battery pack).
`The multisonic® infraControl effectively combines
`aerosol therapy with the need for safe inhalation
`that is environmentally friendly. Its innovative
`design prevents the release of medicines into the
`environment.
`The comfort of patients was one of the main con-
`siderations in the design of the multisonic®
`infraControl.
`
`• Universal usage
`• Optimal penetration of tissues
`• High nebuliser performance and short inhalation
`times
`• Warming of aerosol
`• Low wastage of medicines and ease of setting
`doses
`• Simple and safe to use
`• Easy to clean
`• Noiseless in operation
`• Modern design
`• Small, easy to handle and transport
`• Suitable for the nebulisation of all common
`inhalation solutions (see page 23 for list)
`
`Please read the Instructions for Use carefully to en-
`sure that the unit is used correctly. We would be
`happy to answer any questions you may have and
`would welcome your comments.
`(Service tel. No. +49 367 35/4 63-0)
`
`4
`
`Page 8
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 5
`
`The basic package comprises the
`following components:
`
`1 hand unit
`
`1 nebuliser head
`
`1 mouthpiece
`
`1 sealing ring
`
`1 baffle plate
`
`1 inhalation valve
`
`1 exhalation valve
`
`1 metering aid
`
`1 plug-in power supply unit
`
`1 carrying case
`
`1 set of Instructions for Use
`
`5
`
`Page 9
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 6
`
`Points to note
`
`• The multisonic® infraControl can be used for
`the nebulisation of all inhalation solutions that
`are water-based, including suspensions and na-
`tural therapy agents that are suitable for inhala-
`tion
`
`• If you interrupt the inhalation process please
`switch off the unit by pressing the ON-/OFF Switch.
`
`• Clean the multisonic® infraControl carefully
`after each inhalation.
`
`• Use only medicines that have been prescribed or
`recommended by your physician.
`
`• Carry out the inhalation therapy as directed by
`your physician.
`
`• If you have inhaled the wrong medicine by mis-
`take then inform your physician without delay.
`
`• Never remove the nebulizer head or baffle plate
`if the unit is switched on.
`
`• Fill the medicine chamber with the prescribed
`volume of medicine before each inhalation.
`
`• Never inhale medicines that are left over from a
`previous inhalation unless your physician ex-
`pressly says that you may do so.
`
`• Breathe in quietly and uniformly. The first 3 or 4
`times you inhale do not do so deeply to allow
`yourself time to get used to the aerosol mist.
`
`• After breathing in hold your breath for a short
`time (around 2 seconds) to allow the medicine
`to be deposited properly in the airways.
`
`• If the user does not use the inhalation unit in
`accordance with the Instructions for Use then he
`or she assumes liability for its safe operation.
`
`• Check all the accessories regularly for any changes
`in appearance and replace the valves, nebuliser-
`head, mouthpiece, baffle plate and sealing ring
`at the intervals stated in the Instructions for Use.
`
`• If the unit has turned itself off by reaching the
`residual volume or responds to temperature pro-
`tection, to start at once the plug has to be remov-
`ed from the socket and has to be put in at once.
`
`6
`
`Page 10
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 7
`
`Principle of function
`
`Air outflow
`
`Air inflow
`
`Inhalation valve
`
`Baffle plate
`
`Medicine
`Ultrasound waves
`Ultrasonic
`generator
`(quartz)
`
`7
`
`Exhalation valve
`
`Aerosol exit
`
`Air and particles
`
`Aerosol
`
`Page 11
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 8
`
`An example of periodic inhalation
`
`(mg) Average pulmonary
`deposition (NaCl 0.9%)
`
`Inhalation
`
`Pause in breathing
`
`Exhalation
`
`Breathing in slowly & deeply
`
`Hold breath
`
`Exhale deeply
`
`20
`
`15
`
`10
`
`5
`
`0
`
`Yellow LED is lit
`
`0
`
`2
`
`4
`
`6
`
`8
`
`Duration of inhalation (secs)
`
`8
`
`Page 12
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 9
`
`Using the multisonic® infraControl for the first time
`
`230 VA
`
`Fig. 1
`
`Fig. 2
`
`Pull the stopper out of the
`mains socket of the unit and
`plug in the 12V DC plug of the
`plug-in power supply unit or
`rechargeable battery into the
`socket.
`
`Plug the plug-in mains supply
`unit into the mains socket out-
`let (230V AC).
`
`Fig. 3
`Remove the nebuliser head
`from the hand unit and place
`the hand unit on a flat surface
`such as a table. Ensure that all
`parts of the unit are fully dry
`before commencing the inha-
`lation process.
`
`Please note
`The multisonic® infraControl must not be used in rooms such as bathrooms that have a high humidity level
`because of the danger of electric shock.
`
`9
`
`Page 13
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 10
`
`Inhalation
`
`Fig. 1
`
`Fig. 2
`
`Fig. 3
`
`Fill the medicine – dose and
`quantity as directed by your
`physician – directly into the
`medicine chamber (max. 5 ml).
`Hold the hand unit at a slight
`angle so that no bubbles form
`on the ceramic during filling
`that might prevent or reduce
`the nebulisation process. (Fig. 1)
`
`Ensure that the sealing ring
`sits correctly and that the baf-
`fle plate is inserted correctly in
`the groove as shown.
`
`Place the nebuliser head on the
`hand unit and turn it in the di-
`rection of the arrow until it is
`tight (Fig. 3).
`
`• Always hold the hand unit vertically.
`• Ensure that the medicine chamber always has medicine solution in it.
`• Some drops of the medicine will cling to the walls of the nebuliser
`head and the chamber after use. This is a residual quantity of < 1 ml.
`
`10
`
`Page 14
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 11
`
`Exhalation valve
`
`Inhalation valve
`
`Inhalation valve
`Exhalation valve
`
`Fig. 4
`
`Fig. 5
`
`Fig. 6
`
`Fit the mouthpiece, the inha-
`lation valve (dark blue) and the
`exhalation valve (light blue)
`onto the nebuliser head as
`shown. Make sure that the in-
`halation valve is fitted with the
`valve disc facing downwards
`and the exhalation valve with
`the valve disk facing upwards.
`
`Lift up the hand unit and press
`the button “ON/OFF“. Two yel-
`low function lamps light up to
`show that the unit is operation-
`al (Fig. 5).
`A few seconds after the unit has
`been switched on the aerosol
`mist forms below the baffle
`plate. The mist remains within
`the unit until you inhale.
`
`Bring the hand unit up to your
`mouth. Lay the front of your
`tongue on the mouthpiece and
`put your lips around it.
`Upon inhalation the correspon-
`ding quantity of aerosol will
`directly penetrate the airways.
`Inhale the aerosol as instructed
`by your physician.
`• Always breathe in and out
`through the inhalation unit.
`
`11
`
`Page 15
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 12
`
`Air outflow
`
`Exhalation valve
`
`Air inflow
`
`Dome
`
`Exhalation filter
`(optional)
`
`Inhalation
`filter
`(optional)
`
`Inhalation
`valve
`
`Aerosol
`exit
`
`Optional use of the filter
`A filter can optionally be fitted as an exhalation fil-
`ter to the dome of the mouthpiece. In this case the
`valve is inserted from above in the opening of the
`filter. This filter should be used as an exhalation fil-
`ter if residual quantities of active ingredient pres-
`ent in the exhaled air are to be prevented from en-
`tering the surrounding atmosphere (e.g., when in-
`haling antibiotics).
`The filter, with the valve inside it, can also be placed
`on the dome of the nebuliser head and used as an
`inhalation filter.
`
`12
`
`• If you interrupt the inhalation
`process please switch off the
`unit by pressing the ON-/OFF
`Switch.
`
`• If the unit has turned itself off
`by reaching the residual volume
`or responds to temperature
`protection, to start at once the
`plug has to be removed from
`the socket and has to be put in
`at once.
`
`Page 16
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 13
`
`Examples of various uses of the multisonic® infraControl
`
`Fig. 1
`
`Inhalation via the mouthpiece
`
`Fig. 2
`Inhalation via a mask
`
`Fig. 3
`
`Inhalation whilst lying down
`
`13
`
`Page 17
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`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 14
`
`The multisonic® infraControl
`indicates that inhalation is com-
`plete through the flashing of
`the red LED “End/Off“ and
`then turns itself off automat-
`ically after a few seconds if
`this is not triggered by pressing
`the ON/OFF button.
`The unit can be re-filled with
`medicine after it has been
`cleaned and the inhalation pro-
`cess repeated. The unit has an
`additional safety function that
`is triggered if the unit reaches
`a preset temperature. This en-
`sures that the unit functions
`reliably within a temperature
`range that is optimal for it and
`the medicine.
`Continue to inhale until no
`more aerosol is generated and
`the quantity prescribed by
`your physician has been used
`up. If the 2 red function dis-
`plays flash “End/ Off“ then
`inhalation is complete and
`
`Abb. 1
`
`Abb. 2
`
`Caution:
`Children and persons who need
`care should only use the inha-
`lation unit under the super-
`vision of other adults or care
`personnel.
`
`the unit will turn itself off. Aft-
`er inhalation remove the nebu-
`liser head, the baffle plate and
`sealing ring from the hand unit
`and the mouthpiece and the
`valves from the nebuliser head.
`Shake out the remaining quan-
`tity of medicine that cannot be
`nebulized and clean the hand
`unit and accessories as descri-
`bed in the cleaning and disin-
`fection section.
`
`14
`
`Page 18
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 15
`
`laid out on the cloth and not
`covered. Drying may be acce-
`lerated through the use of
`warm air from a hairdryer (at
`the lowest power setting).
`The unit must be separated
`from the mains supply before
`each cleaning or disinfection
`procedure. Check that the but-
`ton “ON/OFF” has been pres-
`sed and that the yellow LED is
`not lit.
`Pull the plug-in power supply
`unit out of the mains socket
`(230V AC). Remove the nebuli-
`ser head, valves, mouthpiece,
`baffle plate and sealing ring.
`To clean the hand unit pull
`the 12V DC plug out of the
`socket of the hand unit.
`
`Cleaning and disinfection
`
`Please note the following
`The inhalation unit and acces-
`sories must be cleaned before
`being used for the first time,
`after each inhalation proce-
`dure and after storage for
`longer periods. The unit should
`be disinfected at regular inter-
`vals to destroy any micro-organ-
`isms that may be present.
`It is recommended that the unit
`be used only by a single pa-
`tient, especially if the patient
`has chronic disease. If the hy-
`giene recommendations of the
`manufacturer are not followed
`then life-threatening diseases
`may result. Micro-organisms
`need moisture to grow. It is
`therefore important that the
`unit and its individual parts be
`carefully dried after cleaning.
`The unit should be allowed to
`dry in the air or be dried using
`a lint-free cloth. The unit and
`its individual parts should be
`
`15
`
`Fig. 1
`
`Fig. 2
`
`It is extremely important that
`you insert the plug stopper into
`the socket on the unit so that
`no water can enter it (Fig. 2).
`Never immerse the plug-in
`power supply unit or the re-
`chargeable battery pack in
`water as it could irreversibly
`damage them.
`
`Page 19
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 16
`
`sealing ring and filter holder
`should be disinfected in a plas-
`tic container that is suitable for
`use with disinfectants. They may
`be cleaned in a dishwasher or
`disinfected in a vaporizer. The
`nebuliser head, mouthpiece,
`baffle plate, valves, sealing ring
`and filter holder may be boiled
`or autoclaved at up to 134°C.
`The individual parts and the
`unit itself should be carefully
`dried after cleaning and disin-
`fection. See the Hygiene Table
`on page 19.
`
`Please note:
`Alternating between disinfec-
`tion and autoclaving is not suit-
`able as this would shorten the
`working life of the unit.
`
`It is recommended that users
`in Germany use one of the dis-
`infectants listed in the current
`DGHM* list. Preparations based
`on compounds that release
`halogens, strong organic acids
`and oxygen-releasing com-
`pounds are not suitable as they
`may damage the material of
`the inhalation unit.
`
`*German Society for Hygiene
`and Microbiology.
`
`Caution
`• Do not use solvents such as
`acetone or benzene
`• Do not allow water or disin-
`fectant solution to enter the
`electrical connections (power
`socket) of the hand unit.
`
`16
`
`Abb. 3
`It is recommended that gloves
`be worn when cleaning the
`unit. Suitable cleaning agents
`include Palmolive and Fairy
`Ultra and Gigasept, Kohrsolin
`or Sekusept may be used for dis-
`infection. The hand unit and
`the accessories should be wash-
`ed under warm running water.
`The hand unit, nebuliser head,
`mouthpiece, baffle plate, valves,
`
`Page 20
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 17
`
`Disinfection in a vaporizer
`
`Fig. 1
`
`Fig. 2
`
`Fig. 3
`
`Before using the vaporizer for the first time it is very important that you read the Instructions for Use.
`
`Remove the cover and the cen-
`tral section of the vaporizer. Fill
`the base section with water.
`
`Now place the central section
`of the vaporizer on the base
`section.
`
`Place the hand unit “infra-
`Control” with the opening fac-
`ing downwards and the nebu-
`liser head, mouthpiece, baffle
`plate, sealing ring, valves and
`filter holder on the grate of the
`central section.
`
`Caution
`Make sure that the socket of the 12 V inlet of the multisonic® infraControl is sealed with the stopper.
`
`17
`
`Page 21
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 18
`
`Further hygiene measures
`
`Abb. 4
`Cover the central section and
`turn the vaporizer on. The
`water will have evaporated
`after approximately 20 minutes
`and the disinfection process
`will be concluded.
`
`Abb. 5
`In the home:
`After sealing the socket with
`the stopper the hand unit and
`individual parts can be cleaned
`in a dishwasher (open chamber
`side facing downwards).
`
`In clinics:
`After sealing the socket with
`the stopper the hand unit can
`be disinfected / sterilized
`through immersion disinfec-
`tion, placing it in a chemical-
`thermal disinfector (60°C for
`10 minutes) or in a gas steri-
`lizer.
`The nebuliser head, valves,
`mouthpiece, baffle plate, sea-
`ling ring and filter holder can
`be disinfected, gas-sterilized
`or autoclaved at up to 134°C
`as described above.
`
`After cleaning and disinfection of the unit in a vaporizer / dishwasher or after chemical-thermal disinfec-
`tion the unit must be allowed to cool for approximately 30 minutes before removing the parts and start-
`ing the next inhalation procedure.
`
`18
`
`Page 22
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 19
`
`Hygiene Table
`
`Designation
`
`Cleaning
`
`Disinfection
`
`Sterilization
`
`Multisonic
`infraControl unit
`& consumables
`
`Rinsing:
`warm run-
`ning water
`
`Dish-
`washer
`
`Wiping &
`spray disin-
`fection
`
`Immer-
`sion in dis-
`infectant
`solution
`
`Chemical-
`thermal 60ºC
`for 10 mins/
`dishwasher
`
`Steam in
`vaporizer
`
`Auto-
`claving
`at 134ºC
`
`Formal-
`dehyde
`
`Plasma
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`Remove
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`X X X X X X X X X X X X
`
`Unit
`
`Mouthpiece
`
`Nebuliser head
`
`Baffle plate
`
`Valves
`
`Sealing ring
`
`Silicone masks
`
`Filter holder
`
`Filter insert
`
`T-piece
`
`Cornet adapter
`
`Adapter
`
`Oxygen attachment
`
`x = this option may be used
`
`19
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 20
`
`Use of the MN 81300 rechargeable battery pack
`
`The following instructions must
`be followed for the use of the
`rechargeable battery pack to
`ensure that inhalation can be
`carried out whilst travelling:
`
`The rechargeable battery pack
`is a sealed maintenance-free
`unit. Do not attempt to open
`it or replace cells.
`
`Never throw the battery pack
`into a fire.
`
`Please do not throw the bat-
`tery pack away once its service
`life is over – take it to a bat-
`tery collection point instead.
`
`To avoid shortening the life of
`the pack avoid exposing it to
`very intense sunlight, moisture,
`chemicals or extreme tempera-
`ture shock.
`
`LED 1
`green
`
`LED 2
`yellow
`
`LED 7
`LED 6
`LED 5
`LED 4
`LED 3
`
`Socket X1
`
`Yellow
`
`T1 – Button
`
`Fig. 1
`Charging of the rechargeable
`battery pack: The power supply
`(12 V) is connected to the socket
`X1. The green LED 1 will light up
`upon connection to the power
`supply. The start of the charging
`process is indicated by repeated
`flashing of the yellow LED 2.
`The led 2 will light up continu-
`ously after approx. 3 seconds
`and will remain lit throughout
`
`the duration of charging. If the
`battery pack has only a very
`low charge then the charging
`cycle will commence with a
`pulse charge in which the LED
`2 will flash. Once the voltage
`level of the battery pack has
`reached the lower limit value
`the normal charging cycle will
`commence. The LEDs 3 to 7
`indicate the available capacity
`(20% - 100%) of the battery
`pack. The charging process is
`discontinued once a value of
`100% is attained and LED 2
`will go out. The battery pack
`can only be re-charged if the
`charge value is < 100%. If, in
`the course of discharge, the
`LED 3 flashes as a warning then
`the battery pack should be re-
`charged. If the available bat-
`tery capacity falls to 0% then
`the unit is automatically discon-
`nected from the battery pack.
`
`20
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 21
`
`The battery pack must then be
`recharged up to a capacity of
`> 20% (LED 3 lit up) before it
`can be connected to the nebu-
`liser unit.
`The capacity display (LED 3 to
`LED 7) will always be active
`when the supply voltage is
`connected to the socket X1, or
`if the nebuliser unit is connec-
`ted to it.
`The display may be activated
`by pressing the button T1.
`
`• Never use a new battery pack
`until it has been fully charged.
`A new battery pack must be
`charged for a minimum of 4 –
`5 hours.
`
`• The hand unit cannot be oper-
`ated by the battery pack
`whilst it is being recharged.
`
`The battery pack has been spe-
`cially developed for use with
`the multisonic inhalation unit
`and is designed for an inhala-
`tion period of at least 60 min-
`utes.
`
`The initial charge is very impor-
`tant for the performance of the
`battery pack.
`The optimal operating time is
`reached after 2 – 3 complete
`charges. If used and charged
`correctly, the battery pack can
`be charged at least 500 times.
`As with all Ni-MH batteries, the
`battery pack will only deliver
`its full power if it is fully
`charged.
`If the battery pack is mistreat-
`ed then its capacity will be re-
`duced. It should not be stored
`at a temperature > 40 ºC.
`When not in use the battery
`pack should be stored in a cool
`dry place.
`
`21
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 22
`
`Trouble shooting
`
`If the unit malfunctions then please check the
`following:
`
`• Is the unit connected to a power supply (plug-in
`mains supply unit or rechargeable battery pack)?
`Check that the plug is correctly inserted.
`
`• Has the ON/OFF button been pressed?
`Press the ON/OFF button.
`
`• Is the rechargeable battery pack charged?
`If not, recharge the battery pack as described on
`pages 20/21.
`
`• Does the medicine chamber contain the correct
`volume of medicine?
`If not, fill the chamber with inhalation solution
`as described in the Instructions for Use to ensure
`that the nebuliser performance is optimal.
`
`• Has the medicine chamber been treated with
`grease or a detergent in error?
`If so, rinse it out thoroughly with water that is
`warm/hot (approx. 40°C).
`
`• Has an air bubble developed in the ultrasonic
`generator?
`If so, remove it carefully using a blunt instrument.
`
`• Has the overheating protection been triggered?
`Check the quantity of medicine.
`Allow the unit to cool for approx. 5 minutes.
`
`• Has the unit turned itself off by reaching the resid-
`ual volume or responds to temperature protec-
`tion, to start at once the plug has to be removed
`from the socket and has to be put in at once.
`
`22
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 23
`
`Recommendation
`
`Only use medicines that your
`physician has prescribed or re-
`commended.
`If you accidentally inhale medi-
`cines that are not suitable for
`inhalation or your therapy then
`inform your physician straight
`away. You can enter the name(s)
`of your medicines for inhalation
`in the following table.
`
`The inhalation unit has been
`tested with various medicines,
`including Atrovent®, Bero-
`tec®, Berudual®, Bromhexin-
`Inhalat®, Cromoglicin-ratio-
`pharm®, DNCG Stada®, Emser
`Sole®, Eucasil®, Mibrox®,
`Mucosolvan®, Sultanol®, Sur-
`factant, amiloride, Pulmicort®,
`Colistin®, Ilo-medin®, Tobra-
`mycin®, Pulmozym®.
`
`• The unit is not designed for
`emergency life-saving meas-
`ures.
`Respiratory disorders that can
`be treated with the multisonic®
`infraControl include the follow-
`ing:
`- bronchial asthma
`- chronic obstructive bronchitis
`- bronchiectasis
`- mucoviscidosis
`- pulmonary hypertension
`- acute recurring infections
`- chronic diseases of the airways
`with pulmonary emphysema
`
`Name of medicine
`
`Dosage
`
`Dilution
`
`23
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 24
`
`Spare parts (consumables)
`
`Nebuliser head
`85740
`
`Sealing ring set
`85725 (5x)
`
`Mouthpiece set
`85730 (3x)
`
`Filter 85715
`
`Baffle plate set
`85750 (3x)
`
`Valve set
`85721 (1x)
`85720 (5x)
`
`Filter inserts
`85860 (50x)
`
`The mouthpiece, nebuliser head, inhalation valve,
`exhalation valve, sealing ring, baffle plate and filter
`holder will need to be changed according to the
`number of inhalations per day and the degree of
`wear that results from cleaning and disinfection.
`They must be changed at the latest after they have
`become unsightly or exhibit damage.
`If used for the inhalation of active ingredients for
`which no aerosol is allowed to enter the atmo-
`sphere it is recommended that the above parts be
`replaced as follows:
`
`Daily
`Filter insert for the exhalation filter
`Weekly
`Filter insert for the inhalation filter
`the inhalation valve, exhalation valve and
`sealing ring
`Every 3 months
`Filter holder
`Nebuliser head
`Baffle plate
`Mouthpiece
`
`Please contact your specialist dealer or pharmacist
`if you wish to re-order consumables.
`
`24
`
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`

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`
`Optional Accessories
`
`Oxygen insert 85771
`
`Cornet adapter 85772
`
`Mask for infants
`Gr.1-85805
`
`Mask for children
`Gr.2-85810
`Mask for adults
`Gr.3-85820
`
`Filter 85715
`
`T-piece with
`exhalation valve
`85776
`
`25
`
`Larynx mask
`Gr.0-85830
`
`Travel plug set
`81220
`
`Page 29
`
`

`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 26
`
`Guarantee conditions
`
`Important service information
`
`The manufacturer, or its authorized service agents,
`will repair any manufacturing faults or material
`faults that arise during the guarantee period with-
`out charge. No claims for a cancellation of sale, re-
`duction of purchase price or withdrawal from con-
`tract will be entertained. Any damage that results
`from the incorrect treatment of the unit or a failure
`to adhere to the Instructions for Use are excluded
`under this guarantee. The guarantee is invalidated
`if the unit has been worked on by unauthorized
`personnel. This guarantee excludes compensation
`for direct or indirect damage. If you wish to claim
`under this guarantee then please bring the com-
`plete unit to your specialist dealer or return it to
`us, adequately packed and with sufficient postage
`and proof of purchase. The unit is guaranteed for
`a period of 24 months from the date of purchase.
`
`The multisonic® infraControl inhalation unit is an
`electrically-operated unit. It must not be used with-
`out supervision, in potentially explosive atmospheres
`or in rooms with a high humidity.
`Those using this unit must have an exact knowledge
`of these Instructions for Use and must adhere to
`the requirements presented in them. The unit must
`only be repaired by the manufacturer or a service
`agent that is authorized to do so by the manufac-
`turer.
`The unit should be transported using the shoulder
`bag MN 81500.
`If repairs are carried out by agents authorized by
`the manufacturer then the customer should request
`a receipt giving the date, type and scope of the
`repair and name and address of the agent with a
`signature of its representative. Only original acces-
`sories may be used with the unit.
`Otto Schill Medizintechnik will not assume any lia-
`bility if these conditions are not adhered to.
`
`26
`
`Page 30
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 27
`
`Explanation of symbols
`
`Symbol
`
`Meaning
`
`DC
`
`AC
`
`IP XY
`
`Direct voltage
`
`Alternating voltage
`
`Degree of protection against ingress of dust (X)
`and water (Y)
`
`-
`
`+•
`
`0366
`
`Caution – observe documentation
`
`Type 8 usage component
`
`Central positive (connection DC 12 V)
`
`Mark of conformity protected by law
`
`Do not use in humid environments
`
`Not to be worked on by unauthorized personnel
`
`27
`
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`

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`
`Technical Data – multisonic® infraControl
`
`Rechargeable battery pack MN 81300
`Input voltage:
`DC 12 V
`Output voltage:
`DC 12 V
`Ah capacity
`1.5
`Weight:
`0.5 kg
`Continuous operation:
`IP43
`
`Classification
`Continuous operation
`Class of protection II upon operation with plug-in
`power supply unit MN 81200
`Disinfection/sterilization as described on pages 15/ 16
`MMD class IIa.... not to be used in explosive atmos-
`pheres
`
`Type MN 81100
`Noise level:
`Nominal voltage:
`
`Nominal frequency:
`
`Power consumption:
`Weight:
`
`Frequency:
`Nebuliser performance:
`Droplet size:
`
`<15 dB (A) (noiseless)
`DC 12 V (plug-in power
`supply unit MN 81200)
`plug-in power supply
`unit 50 Hz
`12 VA
`0.6 kg - hand unit and
`plug-in power supply
`unit
`2.4 MHz
`approx. 0.6 ml/ min
`MMAD dm50
`approx.3.5 µm
`
`Plug-in power supply unit MN 81200
`Input voltage:
`AC 100 - 240 V
`Output voltage:
`DC 12 V
`Output current:
`1.25 A
`Nominal frequency:
`50 – 60 Hz
`Power consumption:
`20 VA
`Continuous operation:
`IP41
`
`Type B IP 54
`
`28
`
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`

`infracontrol seiten engl. 03.04.2003 15:23 Uhr Seite 29
`
`Kommunikationsbüro Ulm 0403 · Technische Änderungen vorbehalten
`
`Otto Schill GmbH & Co. KG
`Medizintechnik
`Auwiesen 12
`D-07330 Probstzella
`Fon+49 (0) 3 67 35 / 4 63 - 0
`Fax +49 (0) 3 67 35 / 4 63 - 44
`info@multisonic.de
`www.multisonic.de
`
`Page 33
`
`

`

`https://web.archive.org/web/20041028153117/http:/www.schillmedical.co.uk/infracontrol_en.pdf
`
`Page 34
`
`

`

`multisonic®
`infraControl
`
`Inhaling with ultrasonic
`
`Instructions for Use
`
`Page 35
`
`

`

`Overview of inhalation unit
`
`Exhalation valve
`(light blue)
`Inhalation valve
`(dark blue)
`
`Mouthpiece
`
`Plug-in mains supply unit MN 81200
`
`Nebuliser head
`
`Plug 12 V DC
`
`Rechargeable battery pack MN 81300
`
`Function display
`(green, yellow)
`Charging status
`display (yellow)
`Button for
`capacity test
`
`Carrying case
`(depending on design)
`
`Medicine chamber
`
`Function display
`
`ON/OFF switch
`
`Hand unit MN 81100
`
`Baffle plate
`
`Sealing ring
`
`Socket
`12 V (DC)
`Stopper
`for
`socket
`
`Page 36
`
`

`

`Table of Contents
`
`Overview of inhalation unit
`
`Introduction and general information
`
`Starting the unit for the first time
`
`Hygiene: Cleaning, disinfection and
`sterilization
`
`Use of the rechargeable battery pack
`
`Trouble shooting
`
`Information on medicines
`
`Spare parts/consumables
`
`Optional accessories
`
`Service information and guarantee
`conditions
`
`Explanation of symbols
`
`Technical data and classification
`
`2
`
`4
`
`9
`
`15
`
`20
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`3
`
`Page 37
`
`

`

`Dear Patient
`
`The multisonic® infraControl is a powerful ultra-
`sound inhalation unit for preventative and thera-
`peutic deep inhalation that reflects the latest sci-
`entific findings in this area.
`However, the unit has not been designed for life-
`saving emergency treatment.
`The multisonic® infraControl can be used at home,
`whilst travelling and in clinics thanks to its univer-
`sal voltage supply options (mains or rechargeable
`battery pack).
`The multisonic® infraControl effectively combines
`aerosol therapy with the need for safe inhalation
`that is environmentally friendly. Its innovative
`design prevents the release of medicines into the
`environment.
`The comfort of patients was one of the main con-
`siderations in the design of the multi