Operating manual. medical ozone generator. basicplus

Transcription

1 Operating manual medical ozone generator basicplus

2 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 influence of high-voltage. Power supply: Examine whether mains-voltage and device-voltage match. The device tolerates a wide range from 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 single 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.

3 table of contents table of contents 1 SETTING UP OVERVIEW SCOPE OF DELIVERY AMBIENT CONDITIONS...: STORAGE / DECOMMISSIONING DISPOSAL AND RECYCLING SUPPLY OF POWER AND OXYGEN Electrical connection Connect the oxygen bottle Replace /disconnect the oxygen bottle THE PRODUCTION OF OZONIZED WATER Required accessories Preparation Procedure 31 THE BAG TREATMENT Required accessories Preparation Procedure 33 THE RECTAL OZONE INSUFFLATION Required accessories Preparation Procedure 35 2 OPERATING INTENDED USE Application Responsibilities of the user Disclaimer WARNINGS ABOUT INCORRECT USE Implications of incorrect use Avoiding damages by incorrect use EXTRAORDINARY OPERATIONAL SITUATIONS Treatment interruption by user Power failure/ Defective unit or accessories Instructions if smell of ozone is detected BASIC FUNCTIONS Switch on/off the device Concentrations setting Ozone extracting generally Ozone extracting with a syringe Disposal of leftover ozone Internal rinse THE MINOR AUTOHAEMOTHERAPY Required accessories Procedure THE MAJOR AUTOHAEMOTHERAPY Scheme of the MjAT with basicplus Required accessories Treatment methods How to calculate the amount of ozone Preparation Procedure 28 3 TROUBLESHOOTING GENERAL ERROR INDICATION MALFUNCTIONS DURING OZONE EXTRACTION MAINTENANCE CLEANING Cleaning the device Purifying the glass syringe UPKEEPING Adjusting the sensor on the ozone outlet Changing the gasket on the ozone outlet Replacing the mains fuse SERVICE AND REPAIR ACCESSORIES PRODUCT LIST Additional equipment required Consumables sorted by treatment Replacement Order information 46 6 ANNEX TERMS OF GUARANTEE SPECIFICATIONS INDEX... 50

4 1 Setting up Setting up OVERVIEW Take the name (and symbol) for the single operation elements that will be used See the table on the right side for the naming, the symbol and its description to the figures in the images mentioned below. throughout this manual from the following index. You will find an operational description for each element in the column function [e.g. for control lights: the meaning of the light signal (color)]. 1.1 Front view NO. NAME / SYMBOL FUNCTION / SYMBOL 1 Mains lamp O/I green = on red = error (in combination with No. 8) 2 Lamp Rinse O ³ O ² 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 8 Button Permanent ozone lamp Permanent ozone The lamps from 0 including the one of the active value shine (in combination with mains lamp: indication of error type) Constant ozone supply. For bag treatment / water ozonisation. green = active, (timer set to 10 minutes) 9 Button Exhaust lamp Exhaust Start/stop vacuum pump. To exhaust air/ozone for bag treatment green = active Back view 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: 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 broken The warranty for the device is null and void if the the guarantee seal has been damaged! 6 7

5 1 Setting up Setting up Scope of delivery Ambient conditions 1.3 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 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-conditioning 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. 8 9

6 1 Setting up Setting up Storage / Decommissioning Supply of power and oxygen 1.6 If the device is not operated for a longer period of time, or permanently stored, the following points should be noted: An alternating current connection is needed to operate the Ozone device as well as compressed medical oxygen from a lecture bottle. Remove the oxygen bottle. Pack the device dustproof, best in the original packaging. Electrical connection Do not store the device in rooms with high humidity Do not expose to direct sunlight This device meets protection classification VDE class 1. Therefore it needs a power socket and a power cord with protection (grounding). 1.5 Disposal And recycling In according to hygiene and infectious disease prevention lab-disposals like vacuum 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: 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. 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 problems, 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]. Return to: EVOZONE GmbH Herderstr Reutlingen GERMANY 10 11

7 1 Setting up Setting up Connect the oxygen bottle Replace/disconnect 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 generating 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, therefor check always the label!). If a compressed gas cylinder tips over, causing the valve block to be sheared 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 oxygen 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 cylinder valve [e] until it cannot be turned further. Do not use a wrench or other tools; otherwise the seal may be destroyed. 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 regulator 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 residual 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 device and stick a syringe or a bacteria filter into the extraction 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 without a problem and change the bottle. Please leave a pressure of 5-bar left in the bottle to prevent humid air from entering 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. Slide the oxygen tube onto the connection nippel of the pressure regulator [g]. Now open the cylinder valve [f] with about a half turn to the left (counterclockwise), now you can read the actual cylinder pressure on the contents gauge [c]

8 2 Operating Operating Intended use Responsibilities of the user Law regulations prescribe an exact description of the intended use. Operate the device only in this fashion. Application The therapeutic application of ozone is in the responsibility of the attending physician. Indications and contra- indications associated with ozone have to be observed and followed, also the correct use of necessary treatment materials (e.g. anticoagulants such as sodium citrate, ozone resistant materials etc.) 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. Disclaimer 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 treatments 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) This device is only to be operated by authorized medical qualified personnel 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 immediate 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 represents 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! 14 15

9 2 Operating Operating Extraordinary operational situations Instructions if smell of ozone is detected 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. Ozone has a strong, pungent odor that is perceived even at very low concentrations. 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 Power failure/ Defective unit or accessories If the cause of the odor was an incorrect operation: 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. 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. Pull the power plug. If the cause of the odor was a defective device: Close the oxygen cylinder valve. Discontinue treatment and turn off the device. Finish any blood extraction (and attend to the patient) Close the oxygen bottle. 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. See Troubleshooting chapter page 36 If the cause of the odor was a defective the accessory: Discontinue treatment and change the accessory. 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 patient 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

10 2 Operating Operating basic functions Ozone extracting generally In the following the general settings and operations of the ozone device are explained. Make yourself familiar with these procedures before you start a treatment. 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) Switch on/off the device The ozone output takes place via the ozone outlet at the top of the device. For safety reasons the ozone can only be extracted with suitable apparatus having a male Luer connector (e.g. syringe, transfer set, bacteria filter or adapter). 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 continuously. 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 Switch off the device with the power switch on the backside and close the oxygen bottle. The delivered ozone - especially at low concentration is not absolutely sterile! Therefore, the ozone must pass through a bacterial protection filter (sterile, 0.2 micron fineness) to be cleaned before it is used on patients Concentrations setting The ozone concentration can be set step by step from 0 to 80 μg/ml. Set the concentration 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) pressing [a] the buttons [( )/(+)]. Minus (less) or plus (more). 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. The selected concentration is indicated by the lamps on the numbers [b], all the lamps from 0 up to (and including) the selected value glow solid green during operation. (The image exemplify the 10 μg/ml concentration). 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) 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

11 2 Operating Operating 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 siliconfilament 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 generator then starts and the buttons stop [c] and syringe [b] will shine orange. It takes about 3 seconds until the selected 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 continuously 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. 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 disturbance 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 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, syringe and filter. 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 [ O ³ O ² ]. During this phase please wait. After the rinsing phase, the device is ready for use again

12 2 Operating Operating The Minor Autohaemotherapy Operating A minor autohaemotherapy (MiAT) is an autohaemotherapy with little time and material 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 Attach a bacteria filter to the 20 ml syringe and set the device at the desired ozone concentration. Plug the syringe with the bacteria filter 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 syringe and put a cannula size 1 on the syringe [b]. ( Product list and order information for the accessories: chapter page 44) NO. NAME QTY. Extract 3 to 5 ml of blood from the patient [c]. Shake the substance in the syringe well. Change the used cannula with a new sterile cannula of the size 1 [d]. 1 Tourniquet 1 2 Bacteria filter 1 3 Syringe 20 ml, ozone resistant 1 Use a new cannula for the injection. Carefully de-aerate the syringe before injecting. 4 Cannula, size 1 (20G)

13 2 Operating Operating The Major Autohaemotherapy Required accessories 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: 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 The time sequence must be followed exactly to avoid that: ( Product list and order information for the accessories: chapter page 44) 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 [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. We recommend to use the accessories described below. They are specially developed 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. [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. 24 [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! 25

14 2 Operating Operating Treatment methods Mount the plastic holder on the vacuum bottle [a] 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 Remove the protective cap of the vacuum bottle and disinfect the plug Remove the transfer set from the sterile pack and close the blue roller clamp [b] 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: 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 extraction with syringe Chapter page 20) Fill the syringe with ozone in the desired concentration. Connect the syringe to the transfer set. a) one syringe filling O ³ - CONCEN- TRATION GAS VOLUMINA AMOUNT OF O ³ 15 µg/ml 1 50 ml 750 µg b) three syringe fillings O ³ - CONCEN- TRATION GAS VOLUMINA AMOUNT OF O ³ 5 µg/ml 3 50 ml 750 µg Remove the infusion set of the sterile pack and close the orange roller clamp. Connect the Butterfly cannula to the Luer-lock of the infusion unit [f]. 20 µg/ml 1 50 ml µg 25 µg/ml 1 50 ml µg 30 µg/ml 1 50 ml µg 40 µg/ml 1 50 ml µg 50 µg/ml 1 50 ml µg 60 µg/ml 1 50 ml µg 10 µg/ml 3 50 ml µg 15 µg/ml 3 50 ml µg 20 µg/ml 3 50 ml µg 25 µg/ml 3 50 ml µg 30 µg/ml 3 50 ml µg 40 µg/ml 3 50 ml µg 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 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. Fasten the tourniquet onto the patient s arm. After 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 (clotting danger)

15 2 Operating Operating Procedure b) ozonisation by three syringe fillings 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 emptied into the bottle, turn the bottle upside 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 bottle is vented) By aerating the bottle, the reinfusion is initiated. Once a small amount of blood (now mixed up with anticoagulate) 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. Once 80 ml of blood is in the bottle it is time to start the ozonisation. During the following steps the blood extraction must not stop! 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. Close the blue roll clamp of the transfer set [b] swirl the vacuum bottle briefly to mix ozone and blood [c]. Fill the syringe with the second filling 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 torniquet 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 plunger into the bottle [d]. Due to this, a small pressure will build up and let some blood flow back into the patients 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 movement 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

16 2 Operating Operating 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 The external destructor is connected 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 entrance 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 buttons [(+)/( )] [d]. First press the button permanent ozone [e]. NO: NAME QTY. 1 Water ozonisation device Aquanizer 1 2 External ozone destructor 1 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 3 Aqua bidest 1 L The device will shut down after 10 minutes by itself ( Product list and order information for the accessories: chapter page 44) Preparation An internal rinse procedure will begin. Every pipe and valve will be flush with oxygen. The procedure takes a few seconds, during this time the lamp rinse [O ³ O ² ] will shine orange. 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.) The tube must be taken off of the ozone outlet to use the device again after the rinse procedure ends. 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.) 30 31

17 2 Operating Operating The bag treatment Procedure 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. Press the button exhaust [d] the vacuum starts to evacuate the bag. Once the bag is deflate turn off the vacuum pump by press the button exhaust again. Press first the button permanent ozone [e] Required accessories Then remove the plug from the tube with the Luer cone and connect it to the ozone outlet [f]. NO. NAME QTY. 1 Bag treatment set 1 2 Tourniquet / Velcro 1 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 contained in the bag. ( Product list and order information for the accessories: chapter page 44) 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 Preparation Let the ozone soak in for about 15 to 20 minutes. 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. To extract the ozone after the time, pull the tube with the Luer cone out of the ozone outlet 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 destructor and be decomposed to oxygen 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] 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) Adjust the desired ozone concentration on the device

18 2 Operating Operating The rectal ozone insufflation Procedure 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 concentration are usually used during this treatment Required accessories 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. NO. NAME QTY. 1 Bladder syringe 100 ml 1 Insert the catheter carefully to the patient (that is laying in a side position) 2 Female catheter CH 16 1 Then slowly inject the ozone ( Product list and order information for the accessories: chapter page 44) 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 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

19 3 Troubleshooting Troubleshooting GEneral Error indication 3.2 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 contacted and has given clearance to operate the device. Always check the power and oxygen supply first: Is the power cord in the socket and properly connected to the device? Is the mains switch (on the backside) in the on position [ I ]? (The control light for the mains power [ 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. 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 shining 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. MAINS CONCENTRATION PANEL ERROR NUMBER POSSIBLE CAUSE CORRECTIVE 0/I (Ambient/device) temperature below 10 C (Ambient/device) temperature higher 50 C Sensor barrier is out of range (*For the Adjustment of the sensor see chapter page 38) Put the device in a heated space for 30 min. Let the device cool down for a while Adjust the sensor on the ozone exit* 36 37

20 3 Troubleshooting Troubleshooting Malfunctions during ozone extraction The syringe doesn t fill once button has been pressed and the 3.3 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 the possible cause! corrective listet Error, 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 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 yellow lamp of the button syringe flashes after you ve turned on the device even though you haven t put in a syringe:! The sensor is no longer sensitive enough Adjust the sensor ²! 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 The smell of ozone appears around the ozone exit during the extraction with either syringe, bag or during water ozonization:! The gasket inside the ozone exit is wornout/defected Replace the gasket ⁴ ¹ Product list for the accessories chapter page 44 ² Adjustment of the sensor see chapter page 38 ³ Replace the oxygen bottle chapter page 14 ⁴ Replace the gasket on the ozone outlet chapter page 42 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

21 4 Maintenance Maintenance Cleaning upkeeping 4.2 Frequent cleaning and maintenance of the device does not only serve hygiene purposes but safety purposes, conservation of value and durability as well. This way you can recognize possible external changes of the device in time. 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 necessary. You can do the following maintenance procedures by yourself (or contact the Service, if you feel unsure about it: Service, chapter page 43) 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 moistened 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.. 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 Make sure when cleaning that no moisture gets inside the device. Do not use any scouring cleanser.. 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 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. 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. 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! 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

22 4 Maintenance Maintenance Replace the gasket on the ozone exit SERVICE and repair 4.3 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]. 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. Remove the defected gasket on the backside of the cover [b]. The describe maintenance procedures can be done by the manufacturer of an authorized customer service of you dealer. 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]. Any other changes or reparations that are not done by an authorized customer 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 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: EVOZONE GmbH Tel.: Herderstr. 55 Fax: Reutlingen info@evozone.de GERMANY 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 holder, use a little leverage to get them out [b]. Change the used fuses with new 1,6 Ampere slow-triggered fuses [c]

23 5 accessories accessories Product list For the major autohaemotherapy We recommend only using the following auxiliary equipment because it has been especially developed for ozone therapy with this device. VIEW NAME/DESCRIPTION ORDER NUMBER Vacuum bottle with Sodium citrate Additional equipment required size 250 ml, with 12 ml of sodium citrate 3,13 % VIEW NAME/DESCRIPTION ORDER NUMBER Pressure reducer AEROway set to 6 l/min, high pressure manual con- Ozone transfer set For the introduction of the ozone into the vacuum bottle, with bacteria filter 0,2 µm Sangodrop Transfusion set nection G 3/4" for 6mm diameter tubes with steel spike for vacuum bottles, roller Oxygen bottle medical oxygen, compressed 200 bar refillable, lightweight steel 0,8 l ,0 l ,0 l clamp, hydrophobic bacteria filter Syringe 50 ml Easy running latex-free silicone pistons, Aquanizer water ozonisation device 1 liter capacity, mikro air vents, Luer Connector, single (sterile) pack Wing-Flo (19G) laboratory quality glass, standproof Perfusion butterfly cannula, Luer lock con- External ozone destructor nector and cap, different sizes available catalyst: manganese dioxide metal housing, heat resistant to 150 C For the bag treatment Consumables sorted by treatment For the minor autohaemotherapy Bag treatment set sturdy plastic bag, cm, ozone resistant, hydrophobic bacteria filter VIEW NAME/DESCRIPTION ORDER NUMBER For the rectale insufflation Bacteria filter 0,2 μm Bladder syringe 100 ml hydrophobic PTFE-membrane, for aseptic with a straight catheter hub and ventilation, to prevent pollution with additional adapters in the piston rod Syringe 20 ml Female catheter (CH 16) Easy running latex-free silicone pistons, different Ch sizes, smooth surface Luer Connector, single (sterile) pack round tip. Length = 18 cm. Neopoint Hypodermic cannula (No.1) precise cut to minimize trauma, single peel-pack 44 45