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medical ozone generator Operating manual basicPlus

Operating manual - EVOZONE · 2019. 3. 13. · 1 settiNg up 8 settiNg up 1 9 scope of deliverY Unpack and check if the following components are present: • Ozone generator • Power

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  • medical ozone generator

    Operating manual

    basicPlus

  • Notes oN safety !Before initial start-up of the device:

    This operations manual shows the conventional usage of the medical Ozone device (EVOZONE-basicPlus) and how to prevent hazards. This manual should be read and its instructions followed by whoever operates, controls or maintains this device. The warning indications should be followed to minimize the risk of technical defects as well as therapy and attendance mistakes.

    In general:

    • The device is only to be dismounted by an authorized customer service.

    • Expiration of Guarantee follows if this indication is disregarded. Before dismounting device disconnect from power supply, due to the possibility that single components could be under the influ-ence of high-voltage.

    • Power supply: Examine whether mains-voltage and device-vol-tage match. The device tolerates a wide range from 100-250 V mains voltage, there for there should be no settings to be changed on the device its self.

    • Grounding: For safe operation, the device must be grounded. Please use only the provided power cord and connect only to a grounded safety socket.

    • Overloading: Do not connect too many electrical devices to a sin-gle power source. An overloaded electrical outlet may cause fire or short circuit. Do not plug several extension cords together with many devices on a single wall socket.

    • Even when used correctly, especially during the bag treatment or syringe filling, a small amount of ozone can escape. If the smell of ozone is detected, please open immediately a window and provide fresh air.

  • table of coNteNts

    1 SETTING UP 6OVERVIEW ........................................................................... 6

    SCOPE OF DELIVERY ............................................................ 8

    AMBIENT CONDITIONS ...............................................:......... 9

    STORAGE / DECOMMISSIONING ........................................ 10

    DISPOSAL AND RECYCLING ................................................. 10

    SUPPLY OF POWER AND OXYGEN ........................................ 11

    1.6.1 Electrical connection 111.6.2 Connect the oxygen bottle 121.6.3 Replace /disconnect the oxygen bottle 13

    2 OPERATING 14INTENDED USE .................................................................... 14

    2.1.1 Application 142.1.2 Responsibilities of the user 152.1.3 Disclaimer 15

    WARNINGS ABOUT INCORRECT USE .................................... 15

    2.2.1 Implications of incorrect use 152.2.2 Avoiding damages by incorrect use 15

    EXTRAORDINARY OPERATIONAL SITUATIONS ............ 16

    2.3.1 Treatment interruption by user 162.3.2 Power failure/ Defective unit or accessories 162.3.4 Instructions if smell of ozone is detected 17

    BASIC FUNCTIONS .............................................................. 18

    2.4.1 Switch on/off the device 182.4.2 Concentrations setting 182.4.3 Ozone extracting generally 192.4.4 Ozone extracting with a syringe 202.4.5 Disposal of leftover ozone 212.4.6 Internal rinse 21

    THE MINOR AUTOHAEMOTHERAPY ...................................... 22

    2.5.1 Required accessories 222.5.2 Procedure 23

    THE MAJOR AUTOHAEMOTHERAPY .................................... 24

    2.6.1 Scheme of the MjAT with basicPlus 242.6.2 Required accessories 252.6.3 Treatment methods 262.6.4 How to calculate the amount of ozone 262.6.5 Preparation 282.6.6 Procedure 28

    2.1

    2.2

    2.3

    2.4

    2.5

    2.6

    1.1

    1.2

    1.3

    1.4

    1.5

    1.6

    table of coNteNts

    THE PRODUCTION OF OZONIZED WATER ........................... 30

    2.7.1 Required accessories 302.7.2 Preparation 302.7.3 Procedure 31

    THE BAG TREATMENT ......................................................... 32

    2.8 .1 Required accessories 322. 8.2 Preparation 322. 8.3 Procedure 33

    THE RECTAL OZONE INSUFFLATION ................................... 34

    2.9.1 Required accessories 342.9.2 Preparation 342.9.3 Procedure 35

    3 TROUBLESHOOTING 36GENERAL ............................................................................ 36

    ERROR INDICATION ............................................................. 37

    MALFUNCTIONS DURING OZONE EXTRACTION ................... 38

    4 MAINTENANCE 40CLEANING ........................................................................... 40

    4.1.1 Cleaning the device 404.1.2 Purifying the glass syringe 40

    UPKEEPING ......................................................................... 41

    4.2.1 Adjusting the sensor on the ozone outlet 414.2.2 Changing the gasket on the ozone outlet 424.2.3 Replacing the mains fuse 42

    SERVICE AND REPAIR ......................................................... 43

    5 ACCESSORIES 44PRODUCT LIST .................................................................... 44

    5.1.1 Additional equipment required 445.1.2 Consumables sorted by treatment 445.1.3

    Order informationReplacement

    5.1.4 46 46

    6 ANNEX 48TERMS OF GUARANTEE ...................................................... 48

    SPECIFICATIONS ................................................................. 49

    INDEX .................................................................................. 50

    6.1

    6.2

    6.3

    5.1

    4.1

    4.2

    4.3

    3.1

    3.2

    3.3

    2.7

    2.8

    2.9

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    no. naMe / sYMBol function / sYMBol

    1 Mains lamp O/I ●green = on | ●red = error (in combination with No. 8)2 lamp Rinse O³ O² ●orange = internal rinse (device won‘t react for a few seconds)

    3 suction port exhauster / connector for the bag treatment

    4 ozone outlet luer-female connector for ozone extraction (e.g. with syringe) sensor barrier controlled to prevent leaking

    5 button Syringe lamps Syringe

     ●orange = syringe detected, ° orange blinkt = remove syringe° green flash + blip = ready to fill syringe  ●green = filling syringe

    6 buttons to set concentration [–] = less, [+] = more. Range (in steps) from 0 – 80 µg/ml

    7 ozone concentration panel... lamps Concentration

    the lamps from 0 including the one of the active value shine (in combination with mains lamp: indication of error type)

    8 button Permanent ozone lamp Permanent ozone

    constant ozone supply. for bag treatment / water ozonisation. ●green = active, (timer set to 10 minutes)

    9button Exhaust lamp Exhaust

    start /stop vacuum pump. to exhaust air/ozone for bag treatment●green = active

    10 button Stop lamp Stop

    for (irregular) cancel/stop of any active operation ●orange = a operating sequence is active

    11 De-airing Ventilation port. caution: do not cover!

    12 oxygen port connector for oxygen bottle. pressure range: 0 – 8 bar

    13 type plate shows the serial number (ident-Nr.) of the device

    14 test badge proof of electrical safety test (prescribed test interval: 2 years)any deviating national provisions and regulations must be observed as well!

    15 power switch O = off | I = on

    16 Mains socket Voltage range: 100 – 250 V (ac grounding type)

    17 Mains fuse tray insertion: 2 × 1,6 ampere, slow triggered type

    18 Warranty seal note: must not be removed or brokenthe warranty for the device is null and void if the the guarantee seal has been damaged!

    overvieW

    See the table on the right side for the naming, the symbol and its description to the figures in the images mentioned below.

    Front view

    Back view

    1.1 Take the name (and symbol) for the single operation elements that will be used throughout this manual from the following index. You will find an operational de-scription for each element in the column ›function‹ [e.g. for control lights: the me-aning of the light signal (color)].

    1.1

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    scope of deliverY

    Unpack and check if the following components are present:

    • Ozone generator

    • Power cord

    • Oxygen tube (length approx. 2 m)

    • Operating manual

    To use the ozone generator (herafter: device) to the full extent, you will also need the following components that are not included:

    • Pressure reducer (4,5 bar)

    • Oxygen bottle (0,8 / 2 or 5 liter capacity)

    • Water ozonisation device Aquanizer

    ( Product list and order information for the accessories: chapter page 44)

    Please check before setting up the device for external damages. If the casing is damaged, the device must not be put into operation. Consult your dealer in this case

    1.2 aMBient conditions

    To guarantee a failure-free operation of the device choose a suitable location.Consider the following criteria:

    • The device should not be exposed to direct sunlight neither excessive air moisture (35 – 80% relative humidity).

    • Do not install the device close to heat sources or Air-condi-tioning devices.

    • Prevent the operation of the device close to high frequency devices, like radiation devices or transmitters.

    • Place the device on a leveled surface to operate, swing out the front legs of the device.

    For occupational health and safety:

    • Mind that the connecting cable is not laid out in walking or working areas.

    • Do not operate the device in small rooms or rooms without air circulation.

    1.3

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    storage / decoMMissioning

    If the device is not operated for a longer period of time, or permanently stored, the following points should be noted:

    • Remove the oxygen bottle.

    • Pack the device dustproof, best in the original packaging.

    • Do not store the device in rooms with high humidity

    • Do not expose to direct sunlight

    disposal and recYcling

    In according to hygiene and infectious disease prevention lab-disposals like va-cuum bottles, transfusion and perfusion sets of instruments etc. must be disposed properly.

    Do this in the manner of the law of your respective country. See the guidelines for proper disposal of garbage from health services institutes.

    Information about the handling of disposals is found e.g. on the homepage of the Robert-Koch-Institute: www.rki.de

    To be disposed of ozone equipment can be returned to us or has to be supplied at public collection points for recycling. Disposal with household waste is not allowed.

    Return to: EVOZONE GmbH Herderstr.55 72762 Reutlingen GERMANY

    1.4

    1.5

    1.6

    1.6.1

    supplY of poWer and oxYgen

    An alternating current connection is needed to operate the Ozone device as well as compressed medical oxygen from a lecture bottle.

    Electrical connection

    This device meets protection classification VDE class 1. Therefore it needs a power socket and a power cord with protection (grounding).

    The device is designed for an alternating current supply with a voltage from 100V up to 250 V AC. It automatically fits itself to the mains voltage, so it is not necessary to change anything on the device. Therefore the device can be used without prob-lems, even in countries with 110V mains voltage. The maximum power consumption is about 70 watts.

    This is how to connect the device:

    • Connect the small end of the power cord to the mains socket on the back of the device[a].

    • Then install the plug to a grounded outlet socket.[b].

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    Connect the oxygen bottle

    Ozone for medical purpose is produced from medical oxygen. Technical oxygen (e.g. used for welding) contains a remnant of nitrogen. By gene-rating ozone from technical oxygen this nitrogen could cause toxic nitric oxide (NOx).

    Therefore the law requires the use of medical oxygen. The color code for medical oxygen cylinders: white body / white shoulder (code not valid in all countries, there-for check always the label!).

    If a compressed gas cylinder tips over, causing the valve block to be shea-red off, the rapid release of high pressure gas may cause the cylinder to be violently accelerated, potentially causing property damage, injury, or death. To prevent this, cylinders are normally secured to a fixed object or transport cart with a strap or chain.

    The oxygen in the bottle is compressed up to 200 bar, and can only be removed with a suitable pressure regulator. We recommend a pressure regulator which is fixed to 4.5 bar. The pressure range of the device is 1 – 8 bar).

    How to connect the device and pressure regulator with the oxygen bottle:

    • Insert the ribbed nut on the end of the oxygen tube on the backside of the device [b]. Slide the end of the oxy-gen tube over the nipple on the back of the device [a]. Now tighten the nut.

    • Screw the ribbed nut of the pressure regulator [d] by hand on the cylin-der valve [e] until it cannot be tur-ned further. | Do not use a wrench or other tools; otherwise the seal may be destroyed.

    • Slide the oxygen tube onto the con-nection nippel of the pressure regu-lator [g].

    • Now open the cylinder valve [f ] with about a half turn to the left (counter-clockwise), now you can read the ac-tual cylinder pressure on the contents gauge [c].

    1.6.2 1.6.3Replace/disconnect the oxygen bottle

    A full bottle has a pressure of about 200 bar. The bottle is soon to be empty and should be refilled when the pressure drops under 10-bar.

    If you want to connect a new oxygen bottle, you have to remove the pressure regu-lator first. If there still is a high residual pressure within the regulator present (which you can read on the gauge), it will be very difficult to unscrew it.

    • Therefore you must discharge this resi-dual pressure as described below:

    • Close the oxygen bottle completely.

    • Turn on the device with the mains switch.

    • Set the ozone concentration to zero on the ozone de-vice and stick a syringe or a bacteria filter into the ex-traction nozzle to activate the syringe function.

    • The oxygen will begin to flow. You can watch the pressure in the bottle drop on the pressure gauge.

    • You may turn of the device when the needle points to zero.

    • Now you should be able to unscrew the nut wi-thout a problem and change the bottle. Please leave a pressure of 5-bar left in the bottle to prevent humid air from ente-ring the bottle and letting it rust from the inside.

    Read and follow the general details on using and handling oxygen, which you´ll receive from your oxygen dealer.

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    intended use

    Law regulations prescribe an exact description of the intended use. Operate the device only in this fashion.

    Application

    The ozone device is used to produce mixtures out of oxygen and ozone. The area of concentration is adjustable from 0 to 80 μg/ml.

    The device is intended for the following applications:

    • Especially suited syringes can be filled with an ozone-oxygen mixture by the ozone device.

    • With the device you are able to fill suitable bags with ozone or extract and decompose the ozone within the bag.

    • With the help of an auxiliary device (Aquanizer) you can produce ozone water.

    | The device is not intended for the following purpose::

    • The device is not intended for the continuous production of ozone with more than a 33% operation length. (33% operating length means that after a continuous production of 10 minutes a pause of 20 minutes is necessary to cool down.)

    • The device is not intended to do more than 5 bag treat-ments a day. (The internal ozone destructor will otherwise lose power due to humidity, in witch case the device will be damaged.

    You can use the device with an external catalyzer if you want do more than 5 treatments a day. In this case contact your local dealer or EVOZONE.

    ( Order information for the external ozone destructor: chapter page 46)

    2.1

    2.1.1

    2.1.3

    Responsibilities of the user

    The therapeutic application of ozone is in the responsibility of the atten-ding physician. Indications and contra- indications associated with ozone have to be observed and followed, also the correct use of necessary treat-ment materials (e.g. anticoagulants such as sodium citrate, ozone resis-tant materials etc.)

    Disclaimer

    This device is only to be operated by authorized medical qualified person-nel and only with the auxiliary equipment listed in the operations manual!

    Manufacturer does not take liability for the consequences of using and operating with equipment differing from that listed in the operations manual.

    Warnings aBout incorrect use

    Failure in the operation may lead to severe damages of the device. If the operating instructions were not followed properly, liquids (blood/water) can enter the device.

    Especially during the mayor autohaemotherapy or working with the exhauster be sure to use a hydrophobic bacteria filter like it is prescribed in this manual.

    Implications of incorrect use

    Penetrating liquids can cause serious damage to the device. Even when no imme-diate effects on the function occurs, the device will be contaminated and must not be used anymore without a general cleaning and maintenance by the manufacturer (an authorized service).

    The continued operation of a contaminated device is forbidden, it repre-sents a significant risk to the patient!

    Avoiding damages by incorrect use

    • Read and follow the instructions of this manual.

    • Always supervise the operation

    • Use only the correct accessories.

    Operating the device is easy and safe if you comply this!

    2.2

    2.1.2

    2.2.2

    2.2.1

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    extraordinarY operational situations

    Treatment interruption by user

    None of the treatments can be interrupted and resumed at a later time, as the ozone concentration rapidly decreases (reduction of effectiveness) and coagulation can not be prevented in every treatment’s phase

    Should the treatment be interrupted for any unforseen reasons, then the treatment must be stopped completely. Patients shall not be left unattended at any time, not during reinfusions nor during the residence and reaction time of the ozone with the treated area.

    Power failure/ Defective unit or accessories

    Shall a problem arise during the realization of a treatment, like a power failure, a technical dificulty of the machine or the accessories, please follow the instructions below::

    • Turn off the power at the main switch.

    • Pull the power plug.

    • Close the oxygen cylinder valve.

    • Finish any blood extraction (and attend to the patient)

    • Started reinfusions during the major autohemotherapy may (under supervision) be completed normally

    • Bag treatments may continue with the started reaction or residence phase as nomal.

    • Bag treatments which were interrupted during in the filling phase are to be stopped directly.

    Partial and normally filled bags must be emptied manually:

    • Open the window

    • Quickly remove the bag from the pati-ent and keep it close using one hand.

    • Remove the bag connections from the ozone generator.

    • Empty the bag outside, in the open air.

    • Read Instructions if smell of ozone is detected page 17

    2.3

    2.3.1

    2.3.2

    Instructions if smell of ozone is detected

    Ozone has a strong, pungent odor that is perceived even at very low concentra-tions. A short-term appereance of a slight ozone smell is normal and harmless during certain phases of a treatment.

    A heavy, prolonged ozone smell and especially noticeable irritation of the respiratory tract and/or the eyes, might be the result of an operator error or a defect in the medical device or its accessories.

    The following measures should be taken immediately:

    • Open all doors and windows to ensure for fresh air

    If the cause of the odor was an incorrect operation:

    • Make sure that no more ozone odor is perceptible and perform the treatment to the end.

    • If the strong ozone odor persists, discontinue the treatment and evacuate the room.

    If the cause of the odor was a defective device:

    • Discontinue treatment and turn off the device.

    • Close the oxygen bottle.

    • See Troubleshooting chapter page 36

    If the cause of the odor was a defective the accessory:

    • Discontinue treatment and change the accessory.

    2.3.3

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    Basic functions

    In the following the general settings and operations of the ozone device are exp-lained. Make yourself familiar with these procedures before you start a treatment.

    Switch on/off the device

    • Open the valve of the oxygen bottle

    • Switch on the device with the power switch on the backside over the mains socket [a]. The mains lamp will blink for 1 to 2 seconds green and then con-tinuously.

    • Switch off the device with the power switch on the backside and close the oxygen bottle.

    Concentrations setting

    The ozone concentration can be set step by step from 0 to 80 μg/ml. Set the con-centration always when starting a treatment. The previously set value is stored in the device and the next time it is active again. Consider that the device need a few moments to stabilize a concentration.

    • Change the ozone concentration works gradually by (repeatedly) pres-sing [a] the buttons [(–)/(+)]. Minus (less) or plus (more).

    • The selected concentration is indica-ted by the lamps on the numbers [b], all the lamps from 0 up to (and inclu-ding) the selected value glow solid green during operation. (The image exemplify the 10 μg/ml concentration).

    Changing the concentration can always be done before (but not during!) a ozone withdrawal. After changing wait a moment before extract ozone for a treatment.

    2.4

    2.4.1

    2.4.2

    Ozone extracting generally

    For the treatment in the ozone therapy always a mixture of ozone and oxygen is used – but commonly is spoken simply of ozone. (so herafter).

    The ozone output takes place via the ozone outlet at the top of the device. For sa-fety reasons the ozone can only be extracted with suitable apparatus having a male Luer connector (e.g. syringe, transfer set, bacteria filter or adapter).

    The ozone outlet is equipped with a light barrier to prevent unwanted leakage of ozone. A gasket in the outlet nozzle surrounds the Luer-cone during the extraction and seals it off. If the smell of ozone is often detected while filling up syringes the lifetime of the gasket is outworn. Then the gasket has to be replaced.

    See Replace the gasket on the ozone outlet chapter page 42

    The delivered ozone - especially at low concentration– is not absolutely sterile! Therefore, the ozone must pass through a bacterial protection fil-ter (sterile, 0.2 micron fineness) to be cleaned before it is used on patients.

    The bacterial filter at the same time protects the device against direct contamination with bacteria/viruses from the blood (by ozone fumigation / bag treatment: from the skin) of the patients.

    A hydrophobic filter also prevents the penetration of liquids into the device in case of incorrect use /operating error. ( Warnings about incorrect use page 15).

    Only hydrophobic filters ensure a germ-free treatment and prevents the penetration of liquids.

    How to use the bacteria filter is described in the following sections on the individual treatments.

    Use the accessories listed in this manual ( Product list chapter page 44). It is suited for the ozone therapy and already equipped with hydrophobic filters.

    ( Product list chapter page 44)

    2.4.3

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    Ozone extracting with a syringe

    Ozone for injektions, for minor and major autohaemotherapy is extracted from the ozone outlet with a syringe. We recommend using a disposable syringe with silicon- filament lamp that is approved by us. .

    When using syringes made of glass hygienic regulations must be regarded. They request that glass syringes must be sterilized after every treatment.

    Before its first usage, any syringe must be flushed repeatedly with ozone:

    • Insert the syringe | with an attached bacteria filter with a slight twist into the syringe nozzle [a]. The ozone ge-nerator then starts and the buttons stop [c] and syringe [b] will shine orange.

    • It takes about 3 seconds until the se-lected ozone concentration is ready. You will hear an acoustic signal and the green lamp on the button syringe flashes green [d].

    • To fill up the syringe press the button syringe [e] and hold it pressed. The bottom green lamp of the button con-tinuously shines while the syringe is been filled [f ].

    • Once the syringe is completely filled let go of the button syringe. Now press the plunger [g] down to empty and to flush out the syringe.

    It is important to flush out the syringe 2-3 times to dispose of any leftover air in the device as well as in the filter and syringe. This way a precise dosage of the ozone amount is warranted. Flushing with ozone also disinfects the device, sy-ringe and filter.

    2.4.4

    2.4.5

    2.4.4

    2.4.6

    You can begin filling the syringe for the wished treatment once the syringe has been flushed.

    • Insert the syringe with an attached bacteria filter with a slight twist into the syringe nozzle (as described before).

    • Press the button syringe

    • Once the syringe is filled with the desired amount for the treatment let go of the button syringe first and then take the syringe and bacteria filter with a slight twist out of the ozone outlet. (This way you can prevent a build up of over pressure in the syringe and no ozone can leak out.) .

    • If you have used a sterile glass syringe to extract ozone, connect with help of a Luer-Luer syringe-coupler, a sterile, ozone resistant disposable syringe, to the glass syringe.

    • Now inject the wished amount of ozone into the disposable syringe.

    Disposal of leftover ozone

    Leftover ozone in the glass syringe can be disposed of in the device. Leftovers in disposable syringes should be disposed of in the device as well to prevent a distur-bance by the smell:

    • Plug in the syringe with the bacteria filter as usual into the ozone extraction nozzle.

    • As soon as the lamp syringe flashes green you can empty the syringe into the device by pushing down the plunger.

    Internernal rinse

    After an ozone extraction the device starts an internal rinse cycle, to remove the residual ozone in the device (it is destroyed by the internal ozone destructor).

    During the approximately 5 seconds the lamp rinse shines [ O³ O² ]. During this phase please wait. After the rinsing phase, the device is ready for use again.

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    no. NAME QTY.

    1 tourniquet 1

    2 Bacteria filter 1

    3 syringe 20 ml, ozone resistant 1

    4 cannula, size 1 (20g) 2

    the Minor autohaeMotherapY‹

    A minor autohaemotherapy (MiAT) is an autohaemotherapy with little time and ma-terial usage. 3 to 5 ml of blood are taken from a patient with a disposable syringe. The patient’s blood is then strongly mixed with 10 ml of an ozone-oxygen mixture and then intramuscularly injected.

    Required accessories

    ( Product list and order information for the accessories: chapter page 44)

    2.5

    2.5.1

    2.5.2Operating

    • Attach a bacteria filter to the 20 ml sy-ringe and set the device at the desi-red ozone concentration.

    • Plug the syringe with the bacteria fil-ter into ozone exit.

    • You will hear a peep ton after a few seconds, the device is now ready. Fill up the syringe completely and push the substance back into the device to flush the syringe with ozone. Repeat this twice more.

    • For the treatment fill up the syringe with about 10 ml of ozone [a]. Then take out the syringe and bacteria filter from the ozone exit with a slight twist.

    • Take the bacteria filter off of the sy-ringe and put a cannula size 1 on the syringe [b].

    • Extract 3 to 5 ml of blood from the pa-tient [c]. Shake the substance in the syringe well. Change the used can-nula with a new sterile cannula of the size 1 [d].

    Use a new cannula for the injec-tion. Carefully de-aerate the sy-ringe before injecting.

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    no: NAME QTY.

    1 Vacuum bottle with sodium citrate 1

    2 syringe 50 ml, ozone resistant 1

    3 Sangodrop, infusion set 1

    4 Perfusion butterfly cannula 1

    5 ozone transfer set 1

    6 tourniquet 1

    2.6

    2.6.1

    the Major autohaeMotherapY

    80 to 200 ml of blood are taken from a patients vain with of vacuumed bottle during the procedure of a major autohaemotherapy (MjAT). An ozone-oxygen mixture is inserted into the bottle as well with the help of a 50 ml syringe. The then enriched blood is then injected back into the patient with an infusion..

    Observe the applicable regulations and safety rules to prevent infection, especially the requirements of hygiene in the infusion/transfusion. The entire treatment especially the reinfusion must be monitored by the therapist (or a person trained for that)!

    Scheme of the MjAT with basicPlus device

    The MjAT consists of three phases:

    The time sequence must be followed exactly to avoid that:

    • the blood extraction never gets interrupted to avoid clotting in infusion set

    • during ozonization and reinfusion gas bubbles enters into the infusion set to avoid the risk of gas embolism

    We recommend to use the accessories described below. They are specially de-veloped for ozone therapy and matched to the ozone device. The vacuum bottle contains correct dose of sodium citrate as an anticoagulant. Transfer the filter set is equipped with the appropriate filters.

    Required accessories

    ( Product list and order information for the accessories: chapter page 44)

    [1] The vacuum bottle (with sodium citrate) is the treatment container in which the anticoagulant, blood and ozone is mixed. The vacuum is sufficient to extract approximately 250 ml volume (blood and ozone). Accordingly, the amount of blood and the volume of ozone for the treatment must be calculated.

    [5] The Transfer set is the gas line. It is equipped with a protective hydrophobic bacteria filter, which is required for the aseptic treatment. The filter protects the unit from contamination, and in a medical malpractice against the entering of liquid into the device.

    [3] The Infusion set is the blood line. His roller clamp must always be open during the blood extraction. In the ozonation and reinfusion may no gas bubbles enter the blood line!

    2.6.2

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    b) three syringe fillings

    o³-concen-tration

    gas voluMina

    aMount of o³

    5 µg/ml 3 × 50 ml 750 µg

    10 µg/ml 3 × 50 ml 1.500 µg

    15 µg/ml 3 × 50 ml 2.250 µg

    20 µg/ml 3 × 50 ml 3.000 µg

    25 µg/ml 3 × 50 ml 3.750 µg

    30 µg/ml 3 × 50 ml 4.500 µg

    40 µg/ml 3 × 50 ml 6.000 µg

    a) one syringe filling

    o³-concen-tration

    gas voluMina

    aMount of o³

    15 µg/ml 1 × 50 ml 750 µg

    20 µg/ml 1 × 50 ml 1.000 µg

    25 µg/ml 1 × 50 ml 1.250 µg

    30 µg/ml 1 × 50 ml 1.500 µg

    40 µg/ml 1 × 50 ml 2.000 µg

    50 µg/ml 1 × 50 ml 2.500 µg

    60 µg/ml 1 × 50 ml 3.000 µg

    Treatment methods

    To carry out the MjAT, we describe two methods:

    a) ozonisation by one syringe filling unpressurized introduction of the reinfusion ozone dose up to 3000 micrograms blood volume up to 150 ml

    b) ozonisation by three syringe fillings introduction of the reinfusion with slight pressure ozone doses up to 6000 micrograms maximum blood volume of 100 ml

    How to calculate the amount of ozone

    The total amount of ozone is calculated from the ozone concentration and the gas volume. From the tables you can see what concentration setting is to use, get the desired amount of ozone depending on the treatment method:

    Preparation [method a) and b) ]

    Check first if the required auxiliary equipment is complete and ready use. All sterile disposable equipment is to be unpacked right before the treatment begins!

    It must be warranted that there will be no interruption during the treatment because the danger exists that the blood will start clotting in the tube.

    2.6.3

    2.6.4

    2.6.5

    2.6.5 • Mount the plastic holder on the va-cuum bottle [a]

    • Remove the protective cap of the va-cuum bottle and disinfect the plug

    • Remove the transfer set from the ste-rile pack and close the blue roller clamp [b].

    • Insert the pike (needle) of the transfer set in to the point of the plug of the bottle that is marked with a cross [c]. Make sure that the needle is placed inside the riser pipe [d].

    • Flush the syringe ( ozone extrac-tion with syringe Chapter page 20)

    • Fill the syringe with ozone in the desi-red concentration. Connect the sy-ringe to the transfer set.

    • Remove the infusion set of the sterile pack and close the orange roller clamp. Connect the Butterfly can-nula to the Luer-lock of the infusion unit [f ].

    • Insert the pike of the infusion set in the large circle of the plug of the vacuum bottle [g]

    For a) ozonisation by one syringe filling: the vacuum bottle remains first in upright position

    For b) ozonisation by three syringe fillings: hang the vacuum bottle on the infusion pole.

    • Fasten the tourniquet onto the patient’s arm. Af-ter thorough cleaning and disinfection of the puncture area, puncture the vein.

    • Open the orange roller clamp on the infusion set, the blood will be sucked into the bottle.

    • The orange roller clamp must be opened throughout the treatment and the blood flow must not be interrupted (clot-ting danger).

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    Procedure

    a) ozonisation by one syringe filling

    • Once the desired amount of blood is in the bottle open the blue roll clamp of the transfer set [a]. The content of the connected syringe will be suck by the vacuum into the bottle. Thereby it will mix up with the blood.

    • When the syringe is completely emp-tied into the bottle, turn the bottle up-side down and swirl it briefly [b].

    • Now hang the bottle to the infusion pole, then loosen the tourniquet from the patient‘s arm

    • Remove the syringe from the filter set [c] the residual vacuum leak (the bot-tle is vented)

    • By aerating the bottle, the reinfusion is initiated. Once a small amount of blood (now mixed up with antico-agulate) was returned to the patient, there is no more risk of clotting in the blood line

    • Now the reinfusion can be stopped (by closing the orange roller clamp of the infusion set [d]) to mix the blood with ozone still for 1-2 minutes by gentle shaking and swinging the bottle (Open the roller clamp to continue the reinfusion)

    The treatment is ended when the reinfusion of the complete amount of blood is done. Close the roller clamp of the insfusion set and pull the wing cannula out of the vein. To stop any after bleeding put a light compression bandage on the puncture wound. Let the patient rest for a few minutes.

    2.6.6 2.6.6b) ozonisation by three syringe fillings

    • Once 80 ml of blood is in the bottle it is time to start the ozonisation. Du-ring the following steps the blood ext-raction must not stop!

    • Open the blue roll clamp of the trans-fer set [a]. The content of the con-nected syringe will be suck by the va-cuum into the bottle.

    • Close the blue roll clamp of the trans-fer set [b] swirl the vacuum bottle briefly to mix ozone and blood [c].

    • Fill the syringe with the second fil-ling of ozone. Connect the syringe to the transfer set again, open the roll clamp. When the ozone is sucked into the bottle close the roll clamp.

    • Fill the syringe again and open the tor-niquet

    • By the third ozone filling, the vacuum of the bottle will be exhausted and you will have to inject the ozone with a little pressure on the syringe plun-ger into the bottle [d]. Due to this, a small pressure will build up and let some blood flow back into the pati-ents vein. This initiates the reinfusion.

    • Now you can close the orange roll clamp of the infusion because the line is filled with the anticoagulate-mixed blood.

    • Shake the bottle in a circular move-ment for a minute, open the roll clamp to continue the reinfusion [e].

    The treatment is ended when the reinfusion of the complete amount of blood is done. Close the roller clamp of the insfusion set and pull the wing cannula out of the vein. To stop any after bleeding put a light compression bandage on the puncture wound. Let the patient rest for a few minutes.

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    opeRatiNg

    no: NAME QTY.

    1 Water ozonisation device ›aquanizer‹ 1

    2 external ozone destructor 1

    3 aqua bidest 1 l

    the production of ozonized Water

    Ozonized water is especially effective when treating infected or fresh wounds. It can either be used to flush out the wound or put it on compression bandages. Beside this, water ozonizing is a safe and uncomplicated procedure.

    Required accessories

    ( Product list and order information for the accessories: chapter page 44)

    Preparation

    If the Aquanizer is over filled with water, during ozonation moisture can get into the ozone destructor during the ozonisation and nullify its effect. (The moisture prevents the conversion of ozone to oxygen, so that ozone can escape.)

    • Fill the Aquanizer maximum to 10 cm below the neck of the bottle with double-distilled water (about one liter) [a].

    • Close the glass with the glass insert. (the closure seals well, if the glass is moistured with water.)

    2.7

    2.7.1

    2.7.2

    • The external destructor is connec-ted to the exit of the Aquanizer with the provided tube (the port without a rinse pipe) [b].

    • The tube with the Luer-adaptor is connected with its free end to the ent-rance of the Aquanizer (the port with a rinse pipe) [c].

    Procedure

    • Set the concentration at about 60 µg/ml with help of the plus-/minus but-tons [(+)/(–)] [d].

    • First press the button permanent ozone [e].

    • Now plug the free end of the tube with Luer-adaptor to the ozone outlet of the device [f ]. The device will begin to produce ozone and induce it into the water

    • The device will shut down after 10 mi-nutes by itself

    An internal rinse procedure will begin. Every pipe and valve will be flush with oxy-gen. The procedure takes a few seconds, during this time the lamp rinse [O³ O²] will shine orange.

    • The tube must be taken off of the ozone outlet to use the device again after the rinse procedure ends.

    2.7.3

    2.7.2

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    no. NAME QTY.

    1 bag treatment set 1

    2 tourniquet / Velcro 1

    the Bag treatMent

    The infected or wounded area of the body is put in an ozone resistant, disposable bag and is sealed airtight. Ozone is then infused into the bag so that it surrounds the body part that is meant to treat (transcutaneous gas bath). The device extracts the ozone at the end of the treatment and dispose it through the internal destructor.

    Always work with a hydrophobic bacteria filter. Otherwise, moisture can get into the destructor and damage it. The filter also prevents bacteria from entering the device.

    Required accessories

    ( Product list and order information for the accessories: chapter page 44)

    Preparation

    The extremity to be treated should be moistened well with water. Overdraw the plastic bag onto the extremity and fix it gas tight with a Velcro, a torniquet or an adhesive tape.

    Make sure that the treatment bag before sealing is tightly wrapped to the body of the patient so that only little air is in it. This will fasten the exhausting.

    • Connect the tube end with filter [a] to the exhauster (suction port) of the device [b].

    • The other tube end will be connected later, close it first with a Luer-plug [c]

    • Adjust the desired ozone concentra-tion on the device.

    2.8

    2.8.1

    2.8.2

    Procedure

    • Press the button exhaust [d] the va-cuum starts to evacuate the bag.

    • Once the bag is deflate turn off the vacuum pump by press the button ex-haust again.

    • Press first the button permanent ozone [e].

    • Then remove the plug from the tube with the Luer cone and connect it to the ozone outlet [f ].

    Now the ozone starts to flow into the bag. This process is limited to 10 minutes, and will automatically terminate. Then about 6 liters of ozone-oxygen mixture is contai-ned in the bag.

    It is not necessary to fill the bag until it is blown up to its full capacity. It is quite sufficient if the ozone flows around the area to be treated.

    • In the case that you want more ozone; pull the tube with the Luer cone out of the ozone outlet, press the button permanent ozone and put it back into the ozone outlet

    • Let the ozone soak in for about 15 to 20 minutes.

    • To extract the ozone after the time, pull the tube with the Luer cone out of the ozone out-let and put the Luer plug back to it.

    • Now press the button exhaust. The pump will switch on and the ozone will be pumped through the de-structor and be decomposed to oxygen

    The device is designed for about 5 bag treatments a day. We recommend the usage of an external catalyzer if you want to do more than 5 treatments a day. Contact the manufacturer EVOZONE or your local dealer ( order information for the accessories: chapter page 44)

    2.8.3

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    opeRatiNg

    no. NAME QTY.

    1 bladder syringe 100 ml 1

    2 female catheter cH 16 1

    the rectal ozone insufflation

    A rectal ozone insufflation is a topical ozone usage that profits from the ozone´s local and systematical effect. Gas volumes of 50 to 300 ml with a middle concent-ration are usually used during this treatment

    Required accessories

    ( Product list and order information for the accessories: chapter page 44)

    Preparation

    Sterile auxiliary equipment is only to be unpacked right before the treatment begins.

    • A Luer adaptor is found on the plunge of the bladder syringe [a].

    • Take the cap off of the syringe cone and attach a Luer adaptor [b], this way you can fill the syringe directly through the ozone outlet.

    2.9

    2.9.1

    2.9.2

    Procedure

    • Adjust the desired concentration with help of the buttons [ (+) / (–) ] .

    • Flush the syringe as described in ozone extraction with syringe chapter

    page 20.

    • Fill the syringe with the desired amount of ozone.

    • Replace the Luer-Adapter at the cone to a female catheter [c] and lubricate the point of the catheter with some | fat free lubricant.

    • Insert the catheter carefully to the pati-ent (that is laying in a side position)

    • Then slowly inject the ozone

    Regard to use a fat free lubricant (e.g. a lubricant of a water basis) due to the fact that fats and oils can inflate when in contact with oxygen

    2.9.3

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    Mains concentration panel error nuMBer POSSIBLE CAUSE corrective0/I 0 5 10 15

    ° ● ● 3 (Ambient/device) tem-perature below 10° Cput the device in a heated space for 30 min.

    ° ● 4 (Ambient/device) tem-perature higher 50° Clet the device cool down for a while

    ° ● ● ● 13 Sensor barrier is out of rangeadjust the sensor on the ozone exit*

    general

    Any momentary treatments are to be stopped immediately is there be any malfunctions. Operating a device again is only allowed once the cause for the malfunction is found and definite; the manufacturer has been contac-ted and has given clearance to operate the device.

    Always check the power and oxygen supply first:

    • Is the power cord in the socket and pro-perly connected to the device?

    • Is the mains switch (on the backside) in the on position [ I ] ? (The control light for the mains po-wer [ O/I ] on the front shines green when on).

    • Is the oxygen bottle open and is the gauge show a pressure of at least 10 bar?

    Make sure the device is switched on and is connected to the correct power supply, open (or change if empty) the oxygen bottle.

    ( connect the oxygen bottle, chapter page 13)

    If malfunction still occurs:

    • Check if the socket in the wall works with another device (e.g. a table lamp)

    • Change the mains fuse of the device ( Replace mains fuse, chapter page 42)

    If you cant resolve the problem, please contact EVOZONE´s costumer service or your dealer.

    3.1 error indication

    The device runs a few self-tests, for a couple of seconds, when turning it on. If the device finds a malfunction it will indicate that there is an error: the mains light [ O/I ] will flash red ° [a]. Various lights of the ozone concentration panel will shine in addition to this. ● [b]. By the means of how many lights are shi-ning you can tell the number of errors.

    Error chart:

    Tell your service technician or us exactly which lights are shining. You may be able to correct some errors by yourself.

    (*For the Adjustment of the sensor see chapter page 38)

    3.2

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    Malfunctions during ozone extraction

    The ozone outlet on the device is equipped with a sensor to prevent ozone from leaking. The sensor notices once a syringe or bag is safely connected, only then you are able to extract ozone. Errors can occur during the operation:

    In the following are Error, the possible cause ! and thecorrective listet

    The device doesn’t switch on automatically once a filter/syringe is plugged in

    ! The bacteria filter/ isn’t properly plugged in the ozone outlet.

    The filter/cone of the syringe is to be completely plugged in the ozone exit

    ! The device is still in the rinse mode

    Wait untill the rinse mode is ended (a few seconds)

    ! An unsuitable bacteria filter/syringe was used.

    Use only the approved auxiliary equipment ¹

    ! The sensor is no longer sensitive enough.

    Adjust the sensor ²

    The syringe doesn’t fill once button has been pressed and the orange and green lamp of the button “syringe” are shining No smell of ozone is detected

    ! The oxygen pressure is to low

    Open the oxygen bottle or replace it with a new one ³

    If using glass syringes:

    ! The syringe is sluggish due to impurity

    Clean the syringe.

    3.3 3.3 The syringe doesn’t fill once button has been pressed and the orange and green lamp of the button “syringe” are shining The smell of ozone is detected:

    ! The sensor is no longer sensitive enough

    Adjust the sensor ²

    ! The bacteria filter is defected. (e.g. it has a tear in its casing).

    Use a new filter.

    The yellow lamp of the button “syringe” flashes after you´ve turned on the device – even though you haven‘t put in a sy-ringe:

    ! The sensor is no longer sensitive enough

    Adjust the sensor ²

    The smell of ozone appears around the ozone exit during the extraction with either syringe, bag or during water ozoniza-tion:

    ! The gasket inside the ozone exit is wornout/defected

    Replace the gasket ⁴

    ¹ Product list for the accessories chapter page 44² Adjustment of the sensor see chapter page 38³ Replace the oxygen bottle chapter page 14⁴ Replace the gasket on the ozone outlet chapter page 42

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    cleaning

    Frequent cleaning and maintenance of the device does not only serve hygiene pur-poses but safety purposes, conservation of value and durability as well. This way you can recognize possible external changes of the device in time.

    Cleaning the device

    Due to safety measures, turn of the device pull the plug and close the oxygen bottle when cleaning.

    Impurities on the device can be cleaned with a lint-free cloth that is slightly moiste-ned with alcohol. Blood contamination can be removed best with a damp cloth and a drop of dishwashing liquid. The device can also be cleaned with commercially available disinfectants..

    Make sure when cleaning that no moisture gets inside the device. Do not use any scouring cleanser..

    Purifying the glass syringe

    In case of using a glass syringe: The glass syringe is to be cleaned frequently. Only this way a good function is warrantied.

    The glass cylinder and metal plunger can be soaked in alcohol and cleaned with a lint-free cloth. Regard that when putting it back tighter the right side is up. If the glass cylinder is on the wrong way it is not completely sealed.

    Only use sterile glass syringes!

    4.1

    4.1.2

    4.1.1

    4.2upkeeping

    Wear parts must be frequently renewed as well as adjustments must frequently be made. Depending on how often you use the device – the more often it will be ne-cessary. You can do the following maintenance procedures by yourself (or contact the Service, if you feel unsure about it: Service, chapter page 43).

    Adjusting the sensor on the ozone exit

    A sensor barrier automatically notices when an appropriate extraction device with a Luer cone is plug into the ozone exit. The sensor must be readjusted if:

    • the device doesn’t react when plugging in a filter or

    • if the device inadvertently reacts even though there is no filter or any other extraction device plugged in.

    Regard that during the adjustment no light ( sun or strong room lighting) falls in the opening of the ozone exit. The automatic setting will otherwise no be able to make correct results.

    To adjust the sensor barrier follow these steps:

    • Turn the device off with the mains switch and take out any filter or extraction device from the ozone exit during the adjustment.

    • Press the button syringe hold it and turn on the ozone device with the mains switch.

    • Let go of the button syringe. The device will automatically go into service mode. The bottom orange lamp of the button syringe will shine permanently.

    • Press the button syringe again and the device will start setting the sensor for ozone extraction.

    • The adjustment will be finished after 30 seconds. You will notice this due to a loud clack in the device made by a coupling test of a valve. The orange lamp will turn off.

    A flushing of the device follows the adjustment. The device goes into operation mode and is then ready for application again. Redo this procedure if you are not happy with the results of the adjustment. Contact service if an adjustment doesn´t work this way.

    4.2.1

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    Replace the gasket on the ozone exit

    The gasket in the ozone exit has limited life span. A replacement of the gasket is necessary if ozone leaks out. You will need a Phillips-screwdriver size 9.

    • Unscrew the silver cover [a].

    • Remove the defected gasket on the backside of the cover [b].

    • Plug a syringe or a filter through top of the cover and then push the gasket over the cone of the filter or syringe, this way the gasket is centered [c].

    • Screw the cover, with the syringe or filter still plug, in back on [d].

    Replace the mains fuse

    The mains socket on the back of the device contains two fuses in a tray to protect the device from high voltage. In the case of a short circuit or an electrical surge the two fuses will be triggered. The then used up fuses must be replaced:

    It is advisable to always have some spare fuses in stock.

    • Pull the plug out of the socket [a].

    • Remove the safety panel of the mains socket by unscrewing it with a small screwdriver. Insert the screwdriver into the small opening of the fuse hol-der, use a little leverage to get them out [b].

    • Change the used fuses with new 1,6 Ampere slow-triggered fuses [c].

    4.2.2

    4.2.3

    4.3service and repair

    We recommend in addition, to the safety inspections that are required by law, to let your device be inspected and if needed readjusted by the manufacturer every three years.

    The describe maintenance procedures can be done by the manufacturer of an au-thorized customer service of you dealer.

    Any other changes or reparations that are not done by an authorized cus-tomer service leads to the expiration of the manufacturers warranty!

    Please keep the original packing of the device for postal use. In case of a defect contact your dealer or manufacturer first before sending back the device.

    Contact your dealer or EVOZONE directly if any technical questions appear, for customer service, sending back old devices or for spare parts.

    EVOZONE GmbH Tel.: +49 .7121.260 912Herderstr. 55 Fax: +49 .7121.260 91372762 Reutlingen [email protected] www.evozone.de

  • accessoRies5

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    accessoRies 5

    45

    vieW naMe/description order nuMBer

    pressure reducer aerowayset to 6 l/min, high pressure manual con-nection g 3/4" for 6mm diameter tubes

    0100 1026

    oxygen bottlemedical oxygen, compressed 200 bar refillable, lightweight steel

    0,8 l 0100 10392,0 l 0100 10375,0 l 0100 1038

    aquanizer water ozonisation device1 liter capacity, mikro air vents, laboratory quality glass, standproof

    0100 1605

    external ozone destructor catalyst: manganese dioxidemetal housing, heat resistant to 150 °c

    0100 1608

    vieW naMe/description order nuMBer

    Bacteria filter 0,2 μmhydrophobic ptfe-membrane, for aseptic ventilation, to prevent pollution

    0100 1415

    syringe 20 mleasy running latex-free silicone pistons, luer connector, single (sterile) pack

    0100 1033

    neopoint hypodermic cannula (no.1)precise cut to minimize trauma, single peel-pack

    0100 1033

    Bladder syringe 100 mlwith a straight catheter hub and with additional adapters in the piston rod

    0100 1030

    female catheter (ch 16)different ch sizes, smooth surfaceround tip. length = 18 cm.

    0100 1097

    Bag treatment set sturdy plastic bag, 40 × 55 cm, ozone resistant, hydrophobic bacteria filter

    0100 1417

    vieW naMe/description order nuMBer

    vacuum bottle with sodium citratesize 250 ml,with 12 ml of sodium citrate 3,13 %

    0100 1023

    ozone transfer setfor the introduction of the ozone into thevacuum bottle, with bacteria filter 0,2 µm

    2410 3015

    sangodrop transfusion set with steel spike for vacuum bottles, roller clamp, hydrophobic bacteria filter

    0100 1028

    syringe 50 mleasy running latex-free silicone pistons, luer connector, single (sterile) pack

    0100 1031

    Wing-flo (19g)Perfusion butterfly cannula, Luer lock con-nector and cap, different sizes available

    1001 1619

    product list

    We recommend only using the following auxiliary equipment because it has been especially developed for ozone therapy with this device.

    Additional equipment required

    Consumables sorted by treatment

    For the minor autohaemotherapy

    5.1

    5.1.1

    5.1.2

    5.1.2For the major autohaemotherapy

    For the bag treatment

    For the rectale insufflation

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    5.1.3

    Notes

    47

    vieW naMe function / inforMation

    o-ring gasket, 4 × 2 mm

    to seal off the ozone exit of the devicea replacement is required when ozone smell is detected or improper sealing.

    fuse, 2 × 1,6 a; slow triggered

    to protect the device from an electrical surgeReplacement for broken fuse (it is recommended to have these in stock!)

    oxygen feed tubeca. 200 cm

    to connect the oxygen bottle to the device Replace if damaged or contaminated

    coupling nut silver or blue

    to attach the oxygen tube securing the tube without it is impossible.

    glass insert part of the Aquanizer

    to infuse and extract ozone gas this part can be reordered separately if broken or damaged

    Replacement

    These and other spare parts are deliverable when requested

    Order information

    Please ask for further parts and products you may need. We will give you informa-tion on any technical questions. We offer custom made devices and technical so-lutions for your needs. Call EVOZONE during business hours (Mo-Fr: 8 am-6 pm):

    You can order directly on phone (+49.7121.260 912) or E-Mail ([email protected])

    We offer a wide range of products for the ozone and oxygen therapy, as well as common medical and hospital needs.

    Visit our online shop: www.evozone.biz

    More informations and facts about ozone therapy, treatments and our company you can find on our website: www.evozone.de

    5.1.4

  • aNNex6

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    aNNex 6

    49

    typ eVoZoNe basicplus

    serial number / built .................................. / 2 0___ (as shown on the type plate)

    voltage 100 – 250 V ac, 50 – 60 Hz

    power consumption maximum 70 W

    ozone concentration 0 – 80 µg / ml in following steps: 0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80

    concentration tolerance + /- 5 % at an ambient temperature of 21°C

    gas flow rate 10 ml / sec. at all concentration settings

    internal operating pressure 0.3 – 0.4 bar

    range of pressure 1 –8 bar

    permissible medium medical oxygen

    temperature range operating: 10 – 40 °c / storage: -10 – 60 °c

    air moisture 35 – 80 % relative humidity

    dimensions approx. 310 / 290 / 110 mm (width/depth/height)

    Weight approx. 4.1 kg / 9 lbs. (without oxygen bottle)

    safety class system VDe1

    classification-annex ix 2a

    ce-conformity this device meets the eu directives89/336/ee and 93/42 eWg

    ce-ident ce-0483

    terMs of guarantee

    We give warrantee, as the manufactures of this ozone device, to repair any pro-ducts or materials that show manufacturing flaw during our usual business hours free of cost.

    Warrantee expiration is effective 2 years after the date of deliverance.

    The operator must immediately claim manufacturing flaws.

    Any inappropriate usage leads to immediate expiration of the guarantee. Inappropriate usage like:

    • Damage due to disregarding the instruc-tions of the Operations manual.

    • Damage due to inappropriate transportation or storage.

    • Damages due to reparations done by a third party or the operator himself as well as a broken guarantee seal.

    Customer’s service or manufacturers service is exclusively approved for repairing. For manufacturers service contact:

    EVOZONE GmbH Tel.: +49 .7121.260 912Herderstr. 55 Fax: +49 .7121.260 91372762 Reutlingen [email protected] www.evozone.de

    Guarantee claims can only be made with a description of the damage and cir-cumstances.

    6.1 6.2specifications

  • aNNex6

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    6.3 index

    A

    abort the treatment 16aquanizer 30

    B

    Bacteria filter 5, 19bag treatment 32

    C

    ce-conformity 49concentration setting 18customer service 43

    D

    Defect 16, 17Disclaimer 15Disposal 10

    E

    error 15, 38error chart 37

    F

    failure in operating 15, 38

    G

    gas embolie 24glass syringe 20, 40grounding 11, 49 guarantee 48

    H

    Humidty 10Hygiene 24

    I

    internal rinse 21

    M

    Maintenance 40Majorauthaemotherapy 24Minorauthaemotherapy 22Medical oxygen 12

    O

    oxygen 11, 12oxygen bottle 12ozone disposal 21ozone outlet 19, 41ozone dose 26ozone extraction 18, 20ozone smell 17, 39ozone conzentration 18ozone water 30

    P

    pressure reducer 12

    R

    Rectale Ozoneinsufflation 34Repair 43

    S

    sensor adjust 41service 43safety control 43spare parts 43, 46

    T

    technical Data 49

    V

    Vacuum bottle 25

    W

    Warranty 43, 48Water ozonisation 30