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“HC – 3000 LUXE” PROCESS MANUAL 0843

“HC – 3000 LUXE” PROCESS MANUAL 0843 HC-3000electronica_en.pdf · 2016. 7. 14. · Severe hemorrhoids . GI Hemorrhage / Perforation . Digestive perforation suspition . Abdominal

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Page 1: “HC – 3000 LUXE” PROCESS MANUAL 0843 HC-3000electronica_en.pdf · 2016. 7. 14. · Severe hemorrhoids . GI Hemorrhage / Perforation . Digestive perforation suspition . Abdominal

“HC – 3000 LUXE”

PROCESS MANUAL

0843

Page 2: “HC – 3000 LUXE” PROCESS MANUAL 0843 HC-3000electronica_en.pdf · 2016. 7. 14. · Severe hemorrhoids . GI Hemorrhage / Perforation . Digestive perforation suspition . Abdominal
Page 3: “HC – 3000 LUXE” PROCESS MANUAL 0843 HC-3000electronica_en.pdf · 2016. 7. 14. · Severe hemorrhoids . GI Hemorrhage / Perforation . Digestive perforation suspition . Abdominal

INTRODUCTION AND GENERAL INFORMATION Dear customer: Before using for the first time this machine, we recommend you to read thrroughly the manual with the specifications and directions for use, so that you know everything about the correct working and installation of the machine.

HC-3000 LUXE The HC-3000 LUXE is an up-to-date machine, fitted with the latest technical advances; a blend of modern, clean and sturdy techniques; easy to handle with total hygiene and efficacy. The Colon Hydrotherapy allows to be cleaned the large intestine in complete safety.

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1 Patient’s Safety System with full pressure and temperature regulation. High-precision, highly reliable pressure gauge and thermometer. Brass, Steel Stainless & PVC connections, non-toxic Teflon and tygon hoses to prevent water contamination. Materials: steel, stainless steel, Tygon, brass, perspex and PVC. Supply cut-off if maximum pressure or temperature is exceeded. 2 Easy Operation Easily visible & accessible controls. Instructions & labels in Spanish, English, German and Portuguese. Automatic cleaning system. Hermetic, odour-free drainage system. Remote control unit. 3 Economy Sterilization via liquid. Low maintenance. Low consumption. Easy installation. Design and built to last. For spare parts or further information, consult: TRANSCENDENCIAS COMERCIALES, S.L. PARQUE EMPRESARIAL ZUATZU C/ Zubiberri 31, Edificio Urumea Finca 1 – Planta baja Local 1 20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275 E-MAIL: [email protected] // www.transcomsl.com Always quote the serial number of your unit. Serial nº: Packing date: Technician responsible::

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INDICATIONS FOR COLON HYDROTHERAPY

The use of this device should only be applied to clean the colon and always under the control of a doctor.

COUNTER INDICATIONS FOR COLON- HIDROTHERAPY TARGET PATIENTS

No secondary effects have never appeared after the use of this device, always when medically indicated. The pathologies against which one should not use this device are: Sever Cardiac Disease (uncontrolled Hypertension or Congestive Heart Failure) Severe hemorrhoids GI Hemorrhage / Perforation Digestive perforation suspition Abdominal or groinal Hernia Severe Anaemia Cirrhosis Rectum Fissures/ Fistulas Pregnancy (after 3 months) Carcinoma of the Colon or Rectum Recent Colon or Rectal Surgery Renal Insufficiency Pelvical adherences Diverticulitis

CLINICAL SETTING The equipment would be used in a professional office (medical office type equipment) environment with a trained technician operating the machine.

TARGET PATIENTS

The target population would include both male and female of all age groups, with the supervision of the physician.

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COMPONENTS • Control Panel • Remote control Unit • Non-toxic Tubes and Valves • Pressure Regulator against gases or pressures • Flow Adjuster • 2-way Electrovalve, Preparation. • 2-way Electrovalve, Irrigation. • 2-way Electrovalves, Ozone. • 2-way Electrovalve, Cleaning. • 2-way Electrovalve, Trace elements. • 2-way Electrovalve, Disinfectant. • Electrovalve for samples. • Automatic Cleaning System. • Electrical Reversible Actuator • Digital Screen providing information on the following: Operating temperature. Time set for the Session. Session Time Remaining. Information on the session itself. Litres used: At each filling/ emptying interval. At each Session. In total. • Automatic personalised CONTRASTS session for each patient, with modifiable maximum

and minimum temperature parameters and time of intervals. • Safety pressure switch tared to 100 mbar and 1.42 psi. • Safety system providing protection against temperature increases (22- 40 ºC). • Hygienic safety system. Compulsory cleaning process. • Emergency button. Quick discharge (Opening of the valve of waste) in case of any failure

of the power.

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CHARACTERISTICS OF THE HC-3000 LUXE

1. General Switch. Set to (l) to switch on and (O) to switch off the HC-3000 LUXE. It’s lights will tell you about its stage (Lights on Switch on; Lights off Switch off). IMPORTANT: When you switch off the General Switch you should wait for at least 10 seconds before reactivating it again..

2. Screen. This is the machine’s communication outlet with the therapist. It will show a series of messages

regarding the unit’s mode of operation (irrigation, contrast activation,...) and the condition of the parametres selected (temperature, litres of water used,...) The list of messages shown on the screen is shown below.

3. Preparation button. This prepares the machine for the irrigation session. When this button is pressed, we

move into PREPARATION mode, when wemust remove air bubbles from the water tubes and establish the operating temperature. This mode also allows us to select the duration of the irrigation session. There are two parameters set at the factory by default: operating temperature 37ºC, and 45 minutes as the duration of the irrigation session. Should be wish to cut short the preparatory session at this point and cancel the session, we simply press the SHUT DOWN button.

4. Irrigation button. This button takes the user into irrigation mode once the appropriate temperature set in

the preparatory mode has been reached. PAUSE mode: If , in irrigation mode, the therapist should decide that a PAUSE is required in the session and then continue the session, he must press this button again (once). In this way the session enters PAUSE mode (the irrigation stops) and the irrigation button’s light flashes. To reinitialize the session, the button must be pressed again.

5. Slow discharge button. The function of this button is that of opening the valve of waste discharge when

the therapist wants to. The more time one gets pressed the button, the more the valve will open, till it’s completely opened. A partial opening allows doing the waste discharge slowly, so that the therapist can watch carefully though the viewing tube, all the waste and its consistence, thickness, etc

6. Fast discharge button.. This button has the same function as the slow discharge this is to open the waste

going, but this time it is a total opening. Press this button at the patient’s request or when the colon is full of water. Press this button at the patient’s request or when the colon is full of water. The waste is taken through the discharge tube and is visible through the viewing tube.

7. Filling button. Through the use of this, the waste discharge is completely closed. This makes that the water

going through the irrigation tube (and through the rectal nozzle connected to it) gets into the patient’s large intestine. The FILLING must finish when the colon is full or when the patient ask for it and also when the doctor advises so. Should intra-intestinal pressure exceed 100 mbar or 1.422 psi, the HC-3000 LUXE unit shall disconnect irrigation mode automatically(it is not allowed to get water into the patient) and activate FAST DISCHARGE (the valve of waste discharge is completely opened and allows us to get rid off of the water and waste of the large intestine) In this case the digital screen shall provide us the following message:

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IRRIGATION SESION MAXIMUN PRESSURE 100 mBAR TIME REMAINING: XX MINUTES

DECILITRES INTERVAL: XX DECILIT

As pressing Filling the litre-counter starts working (the litre-counter of the interval should be in 0), which indicates the amount of water that has been introduced into the patient (Decilitres of the interval). This data will help us to know the size of the intestine and in case there is any obstacle in it, where it is located. This counter should be placed in 0 once Fast Discharge is activated.

8. Trace elements button. When this button is pressed during the irrigation session, the irrigation tube

entering the patient administers Trace elements that are placed in the deposit of the Trace elements ( the quantity of the elements that are introduced depends on the water flow selected. See Introduction of Trace elements and the draw below) This function has been factory-preset to disconnect automatically after two seconds. During that time, the screen does not show the Trace elements-Activation message. The use of Trace elements is only allowed when the Filling function is activated. If Trace elements is disconnected during ozonization session the only message on the screen will be OZON ACTIVATED indicating by the lightning of the button that the Trace elements are being introduced. If the Trace elements deposit were bellow the minimum level during the preparation phase, the machine will indicate

ATTENTION NO TRACE ELEMENTS

During the time of introduction of trace elements, the following message will show on the screen and the Trace elements button will be lighted up.

IRRIGATION SESSION TIME REMAINING: XXMINUTES

DECILITERS INTERVAL: XX DECILIT 9. Ozone button. This button ozonizes the water for the irrigation session with a 1,5 mgr. Per liter

concentration. To disconnect this function it is enough to push the button again. During the time that this function is activated, one can read on the screen the following message:

IRRIGATION SESSION

OZON ACTIVATED REMAINING TIME: XXMINUTES

DECILITERS INTERVAL: XX DECILIT

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10. Samples- and Outcoming of samples button. With this button we can get, at request of the healthcare personnel, samples of the evacuated wastes for its further analysis. When we push this button, FILLING is automatically activated (that is to say, the outcoming os wastes gets closed), and the outcoming of samples gets open.. Through it the elements to analyze go to the recipient that we have placed beforehand. Pushing this button again, this outcoming will close itself, Fast Discharge will be activated and we will be able to go on with the session. When pushing the Samples button, Trace elements will get deactivated, in the case that they it had been previously activated.

11. Cleaning Button. This button initiates the cleaning session only when the machine has terminated the

irrigation session or when it has been cancelated with the Stop button. Filling will work when the samples flexible and the filling plug are both connected. The cleaning session can by no means be left out. That is to say, after an irrigation session, the machine must be necessarily cleaned. This way one can prevent that a carelessness provokes not unwanted contaminations. The detailed sequence to disinfect the machine can be found in INSTRUCTIONS FOR THE DISINFECTION AND MAINTENANCE OF THE HC-3000 LUXE. On the digital screen appear two messages :

CLEANING SESSION

CONNECT SAMPLES FLEXIBLE CONNECT CLEANING PLUG

CLEANING SESSION

SAMPLES FLEXIBLE CONNECTED CLEANING PLUG CONNECTED

CLEANING SESSION

REMAINING TIME...................XX MINUTES

CLEANING SESSION FINISHED

12. Stop Button. This button stops the Irrigation as well as the Preparation session when desired. Important :

This button must not be pressed to make a pause. Its function is exclusively to abort the preparation session once initiated and to start another preparation session or to abort / finish an irrigation session in order to go on necessarily to Cleaning. When the Stop button is pushed during the irrigation session, these messages appear on the screen :

IRRIGATION SESSION

FINISHED PLEASE WAIT

IRRIGATION SESSION

FINISHED PRESS CLEANING TO CONTINUE

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13. Irrigation Outcoming. In this shank will be connected the irrigation tube, which drives the irrigation water from the machine into the patient, as well as the substances used in the therapy such as trace elements, salt, coffee, ozone, etc.

14. Incoming of wastes. In this shank will be connected the evacuation tube, which takes the water and wastes

that come from the colon of the patient. When we proceed to clean the machine, the cleaning plug must be connected to this entrance.

15. Temperature button. Pushing this button we get to the session temperature with which we want to work if

we want to increase it or reduce it. Once the temperature selected, push again to record the data. 16. Control button ó . Allows to select the temperature or the time of the session according to the selected

parameter, being possible to increase or reduce its value in one unit per each pulsation. 17. Temperature screen. Shows each moment the water temperature. If we are in Preparation it indicates the

water temperature getting ready for Irrigation and, once in Irrigation, appears the temperature of the water that is being introduced into the patient.

18. Contrasts button. It allows to go to the Irrigation session under the CONTRASTS mode, that is, Irrigation

during a period of time selected at two different temperatures, also selected by the healthcare personnel. The limit contrasts temperatures will be: Minimum temperature 25º C, maximum temperature 36º C. The contrasts minimum temperatures vary between 25 and 29ºC. The contrasts maximum temperatures vary between 30 and 36ºC. To make the session under the contrasts mode, being under irrigation, go to irrigation in pause and push the contrasts button. Once pushed, the following screen appears

CONTRASTS SESSION

PUSH CONTRASTS TO START SESSION SESSION TIME ..... XX MINUTES

XX AT XX ºC EACH X MINUTES

As the message shows, it is necessary to push again the Contrasts button if we want to iniciate this mode. Once pushed, Fast Discharge will get activated and the screen will show the following message :

CONTRASTS SESSION

REMAINING TIME XX MINUTES DECILITERS INTERVAL XX DECILIT

In this case the date named as X are time or temperature values to which we will be able to get to just pushing the corresponding button (Time or Temperature button), in each moment , pushing the control buttons ó this values can be increased or reduced in one unit per pulsation in order to adapt the contrasts session to our patient’s needs. As contrasts parameters are being selected and when working under the contrasts mode, the contrasts button will be on and when it goes on to irrigation it will go off. The

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minimum flow that will be used in this phase of the session will be 30 liters per hour. If one wants to make it under contrasts, change of the contrasts parameters, push the irrigation button (to go to pause mode) and push contrasts until the screen changes the message.

19. Time button. To accede to the time the irrigation session lasts. Once the time is selected, push again to

record the data. (The time selected cannot be nor inferior to 20 minutes, nor superior to 70 minutes) 20. Liters button. Shows the following message giving information about the number of liters consumed

during the previous session, the total number and the number of sessions made with the machine. :

WATER LITERS CONSUMED LAST SESSION XX LITERS

TOTAL XXXXXX LITERS IN XXXX SESSIONS 21. Remote control. . The controls of preparation (P), Irrigation (I), Slow discharge (SD), Filling (F), Fast

discharge (FD), Stop (S), Ozon (OZ) and Trace elements (OL), can also be activated using the remote control attached to the equipment, directing its forder lense towards the temperature screen (17) and pushing the desired option.

22. Emergency button. While pushed, fast discharge works (Opening of the wastes outcoming valve) It must

be pushed in the case of an electric failure or a failure in the microchip that controls the performance of the electric card.

23. Pressure indicator This is the manometer indicating the water pressure inside the colon of the patient in

each moment of Irrigation. Transcendencias Comerciales S.L.establishes that the maximum pressure is between 100mbar ó 1.422 psi. This preestablished value can be either increased or reduced at request of the healthcare personnel. However, in this last case, Transcendencias Comerciales S.L. will not accept any possible liability due to possible damages caused to the patient or to the equipment. When, due to an increase of pressure this one exceeds 100 mbar, this message will appear on the digital screen :

IRRIGATION SESSION

EXCESSIVE PRESSURE-MAX 100 Mbar REMAINING TIME : XX MINUTES

DECILITERS INTERVAL: XX DECILIT If the Irrigation pressure exceeds 100 mbar Irrigation gets stopped and Fast discharge gets activated for the evacuation of the patient’s large intestine preventing this way any possible damage.

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24. Flow Regulator. It controls the water flow in liters per hour that we want to introduce into the patient and the water flow pressure. At the bottom of this regulator there is a circular control. Turning it to the right, flow and therefore pressure get reduced. The opposite happens whenif we turn it to the left.

It must operated slowly so the temperature can stabilize. 25. Visor tube. Translucid tube with a light inside to improve vision of the wastes evacuated from the patient

during the session. 26. Cleaning racor deposit. This is the cleaning plug lodge. It will have to be kept completely clean. 27. Samples flexible. This connexion allows the disinfection of the outcoming of samples circuit. IMPORTANT. This samples flexible must stay connected during the whole cleaning session.

28. Drainage tube connexion. The drainage tube must be connected to this element of the equipment. 29. Oxygen entrance. Connexion that allows us to introduce oxygen ONLY during the irrigation session. 30. Plug. This plug or connexion to the electric net must be placed one meter from the vertical of the machine. IMPORTANT : The plug connexion to the machine must have a ground connexion. 31. Fuses. The equipment is protected by four fuses (two 4 A and another two 2 A) 32. Rolling base. The equipment has four wheels to make its movement easier. The two rear wheels have

brakes to immobilize the equipment when necessary. One has only got to push down hard the plastic pieces of the plate.

33. Identification plate. Every equipment has an identification plate with the following data: Manufacturer’s name TRANSCENDENCIAS COMERCIALES S.L. Model HC-3000 LUXE Voltage. 220 V Frequency. 50 Hz Type of protection I Power 155 VA Cold water entrance pressure 2 bar Hot water entrance pressure 2 bar Oxygen entrance maximum pressure 100 mbar Manufacturing date XX/XX/XX Nº de serie XXXXXXXX

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LIST OF MESSAGES APPEARING ON THE DIGITAL SCREEN

TRANSCENDENCIAS COMERCIALES HC 3000

SERIAL Nº. XXXXXXXXX

PREPARATION SESSION PLEASE WAIT

PREPARATION SESSION

PLEASE WAIT SESSION TIME 45 min

WORK TEMPERATURE 37 GRAD C

PREPARATION FINISHED

TO CONTINUE SESSION PUSH IRRIGATION

IRRIGATION SESSION

REMAINING TIME : XX min

DECILITERS INTERVAL: XX DECILITERS

IRRIGATION SESSION PAUSE

REMAINING TIME: XXmin DECILITERS INTERVAL: XX DECILITERS

IRRIGATION SESSION

OZONE ACTIVATED REMAINING TIME :XXmin

DECILITERS INTERVAL: XX DECILITERS

IRRIGATION SESSION EXCESIVE PRESSURE-MAX 100 Mbar

REMAINING TIME: XX min DECILITERS INTERVAL: XX DECILIT

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DE IRRIGATION SESSION EXCESIVE TEMPERATURE >40 GRADS

REMAINING TIME : XX MINUTES DECILITERS INTERVAL: XX DECILIT

IRRIGATION SESSION

INSUFFICIENT TEMPERATURE <22 GRADS REMAINING TIME : XX MINUTES

DECILITERS INTERVAL: XX DECILIT

IRRIGATION SESSION FINISHED

PLEASE WAIT

IRRIGATION SESSION FINISHED

PUSH CLEANING TO CONTINUE

WATER LITERS CONSUMED LAST SESSION XXX LITERS

TOTAL XXXXXX LITERS IN XXXX SESSIONS

CONTRASTS SESSION TO START SESSION PUSH CONTRASTES

SESSION TIME..... XX MINUTES XX TO XX GRADS EACH X MINUTES

CONTRASTS SESSION

REMAINING TIME XX MINUTES DECILITERS REMAINING XX DECILIT

CONTRASTS SESSION

FINISHED

PLEASE WAIT

CONTRASTS SESSION FINISHED

PUSH CLEANING TO CONTINUE

CLEANING SESSION

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CONNECT SAMPLES FLEXIBLE

CONNECT CLEANING PLUG

CLEANING SESSION

SAMPLES FLEXIBLE CONNECTED CLEANING PLUG CONNECTED

CLEANING SESSION

REMAINING TIME XX MINUTES

CLEANING SESSION

FINISHED

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STEP BY STEP DESCRIPTION OF A SESSION Note: The healthcare personnel must stay with the patient all the session long. 1. Open the water inlet key. 2. Turn on the main switch. On the screen appears the following message :

TRANSCENDENCIAS COMERCIALES

HC-3000 SERIAL Nº XXXXXXXXX

3. Press Preparation. The following message appears :

PREPARATION SESSION PLEASE WAIT

SESSION TIME 45min WORK TEMPERATURE 37 GRAD C

4. Select the session parameters: 4.1. Time: Press Time and select with the Control button the duration in minutes (push to diminish and to

increase it). Once selected press Time again. 4.2 Temperature: Push Temperature and select with the Control button the water temperature we want to work

with ( to diminish and to increase it).Once selected, press temperature again. The selected temperature must be between 25ºC and 37ºC, (above and below theses limits the equipment does not allow us to work). Flow : Select in the Flow Regulator the number of liters per hour we want to work with during the session. Recommended values : between 68 and 80 liters per hour or between 16 and 19 gallons. Nevertheless it is possible to work with a bigger flow without danger for the patient. During the preparation session the bubbles must be eliminated from the pipes. In order to do that, before setting the recommended value, open the flow to the maximum twisting the inferior control anticlockwise . After a while, lower to the minimum twisting clockwise. Alternate both situations until no bubbles go through the column of the regulator.

5. Wait to until we reach the selected temperature. The temperature of the water will appear on the screen. The

screen indicates that the desired temperature has been reached and Irrigation can start. It does not allow to go to irrigation during the lapse of time that it needs to set the temperature.

6. Insert the speculum smoothly into the patient using some vaseline.

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7. Connect the irrigation tube to the speculum and to the outcoming of irrigation. When the speculum is already introduced into the sphincter of the patient, take either side of the irrigation tube and connect it with a little pressure to the shank that protrudes from the side of the speculum introducing it until it is totally adjusted. The other end of the tube must be connected to the outcoming of irrigation.

8. Connect the evacuation tube to the speculum and to the incoming of wastes. The same as with the irrigation

tube, the evacuation tube must be hand-connected with a little pressure. An end of this tube (anyone of them) is connected to the rear side of the speculum, introducing this part into the tube. The other end must be connected to the entrance of wastes a shank-shaped metallic piece, that must stay connected inside the evacuation tube.

9. Push Irrigation. In this position the water will come in and out continuously. One valve is activated and

allows the water come into the speculum and out of it through the evacuation tube without entering the patient’s colon and leaving the equipment through the drainage outlet. The water will only come into the patient if Filling is pushed.

10. Push Filling for the water to come into the patient as long as Irrigation is activated. When this button is

pushed the wastes outlet valve gets closed. The clean water that circulates, because Irrigation is activated, fills the visor tube and the evacuation tube until it reaches the speculum. Once there, the irrigation water comes into the colon preventing that way the possible contamination from the the visor tube or from the evacuation tube.

11. Once enough water has come into the patient’s colon, press Fast Discharge (this function deactivates the

Interval Deciliters meter) or Slow Discharge. The pressure produced by the water inside the patient appears on the manometer of the control panel. The volume of water that is enough is given by the following elements :

- Sensation of fullness. If the patient feels that his colon is full, he must tell the healthcare personnel who will press Fast or Slow Discharge (deactivating Filling that way) to go on with the session.

- Pressure reflected on the manometer, if the pressure is under 1,42 psi or 100 mbar . The healthcare personnel will be able to go on with the session activating Fast or Slow Discharge. If he pressure exceeds 1,42 psi or

- 100 mbar the equipment will deactivate automatically the irrigation process and will also connect automatically Fast Discharge.

One has to keep in mind the existing relation between the volume of water introduced into the patient and the pressure exerted by this water. A bigger volume implies bigger pressure and vice versa. The patient, apart from telling the healthcare personnel his wish to stop irrigation can, without any danger, take away the speculum by himself.

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12. If the healthcare personnel wish to stop Irrigation for a while, it is enough to push Irrigation again. The light

of the button will flush. The healthcare personnel will be able to go on with the session pushing Irrigation once more.

13. Continue with the session alternating Filling and Fast or Slow Discharge. 14. When the selected session time comes to an end the following message appears:

IRRIGATION SESSION

FINISHED PLEASE WAIT

Then a new message:

IRRIGATION SESSION FINISHED

PRESS CLEANING TO CONTINUE That way the healthcare personnel is invited to clean the machine which must be done necessarily because other

way, the machine will not allow to go to Irrigation. 15. The same way as described before, the healthcare personnel will be asked to start Cleaning if the session

has finished pushing Stop at request of the patient or by decision of the healthcare personnel. 16. Once the session finished and before starting Cleaning, disconnect the irrigation tube and rise that end so

that the water remaining in the tube comes out to the evacuation tube. 17. Remove smoothly with one hand the speculum (still connected to the irrigation tube already disconnected

from the equipment and to the evacuation tube) from the patient and with the other hand put a sanitary napkin on his sphincter so he can go to the bathroom. With the other had rise the kit removed from the patient so that the wastes that may have remained in the evacuation tube can go out through the visor tube, disconnecting that moment the evacuation tube from the equipment. The kit that has been used in the therapy must not be used again.

18. Disinfect the equipment following the instructions described in “Disinfection”.

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SAMPLES If doubtful substances are detected and we decide to take samples of the wastes evacuated by the patient during the session, follow these steps: 1. Place a recipient to collect the samples at the outlet mouth of samples. 2. Push Samples 3. The outlet of wastes will close and the outlet of samples will open so that the elements to be analyse can

come out. 4. Once the samples collected, push Samples again . That way the outlet of samples closes and the

communication to the drainage of the wastes opens. 5. Go on with the session.

WHEN THE SESSION IS FINISHED

1. Disconnect the speculum from the patient and the irrigation and evacuation tubes from the equipment (such

as indicated in the description of a session) 2. Disinfect the equipment following the instructions detailed in the disinfection process.

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INSTRUCTIONS FOR THE DISINFECTION AND MAINTENANCE OF THE HC-3000 LUXE

Once the irrigation session has finished because time has run out or because the healthcare personnel has decided to finish it with the Stop button, the machine invites to start the Cleaning session. On the screen appear the following messages:

IRRIGATION SESSION FINISHED

PUSH CLEANING TO CONTINUE

Once the Cleaning button has been pushed, the following message can be read:

CLEANING SESSION

CONNECT SAMPLES FLEXIBLE

CONNECT CLEANING PLUG

Reached this point, the health care personnel has to connect the cleaning plug and the samples flexible. These two elements must be necessarily connected because otherwise, the cleaning session could not start.

CLEANING SESSION

SAMPLES FLEXIBLE CONNECTED

CLEANING PLUG CONNECTED

Few seconds afterwards this message confirms that the cleaning sequence has started and 18 minutes are left for the machine to make the cleaning process by itself..

CLEANING SESSION

TIME REMAINING XX MINUTES

The machine itself tells at the beginning of each session if there is or not enough disinfectant for the session. If there were not enough the following message would appear:

ATTENTION NO DISINFECTANT

It is advisable, every ten sessions to make this cleaning process only with water .

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When the cleaning session finishes, the machine allows to start a new session appearing the following message:

TRANSCENDENCIAS COMERCIALES HC-3000

SERIAL Nº XXXXXXXXX The HC-3000 LUXE device owns a program that does not allow any further sessions if Cleaning has not been done. The Cleaning sequence of this machine goes as follows: 1. Sweeping from the visor tube to the outlet of wastes only with water to eliminate wastes that could have

remained. This wastes are carried to the outlet of wastes. 2. Sweeping from the visor tube to the outlet of samples only with water to eliminate wastes that could have

remained. This wastes are carried to the outlet of wastes. 3. Fill from the wastes entrance to the outlet of wastes with water and disinfectant (poured beforehand in its

deposit) It will stay like this for 13 minutes, time necessary to disinfect the whole circuit. 4. The visor tube is emptied of disinfectant and water. 5. Rince from the visor tube to the outlet of wastes (only water). 6. Rince from the visor tube to the outlet of samples (only water). 7. Fill the whole circuit only with water and leave for a minute to rince again . 8. Empty the circuit.

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RECOMMENDED DISINFECTANT Transcendencias Comerciales S.L. recommends the following product for the disinfection of its equipments, checked and tested by our technical department : CIDEX ® Activated Glutaraldehide Solution Esporicide, Fungicide, Virucide, Tuberculicide, Bactericide y Pseudomonicide Manufacturer: Johnson & Johnson Medical Limited, Garagrave, Skipton, BD233RX UNITED KINGDOM

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CLEANING MAINTENANCE OF THE INSIDE OF THE EQUIPMENT To keep the cleaning circuit in perfect conditions, every 10 sessions, disinfect only with water instead of water and disinfectant.

CHANGE OF THE CARTRIDGE OF THE FILTER These cartridges must be changed at least every 75 sessions,or either every six months , though this time can be shorter depending on the type of water in the area where the machine is installed.. To change the cartridge, follow these instructions: 1. Close the general water key. 2. Turn on the machine.

3. Push the preparation button. 4. When the water flow has come down to zero, turn off the machine and disconnect it from the electric net.

5. Close the valve of the flow regulator twisting it to the right. 6. Open the door named with the word “filter”. 7. Hold the glass of the filter. Twist to the left until the glass is completely free from its bracket 8. Throw away the used cartridge and put a new one, remembering always to put and adjust the O-ring seal. 9. Rub smoothly the mouth of the filter with a little bit of vaseline. 10. Adjust the glass to its support, twisting the glass of the filter to the right. IMPORTANT: Filters must be changed with new filters. Never reuse them.

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MANTENANCE

Your Hydrotherapy of Colon Equipment does not need any programmed maintenance. Now then, an adequate care and a preventive maintenance together with a correct observance of the use and disinfection guide allows to keep the equipment in perfect conditions for years. Years of use may lead to a normal wear of the equipment. To the first sign of problem or that the equipment does not work properly, inform Transcendencias Comerciales S.L. immediately. It should be checked before being used again. Check that every water line and connexion is in perfect conditions and there are no escapes. To clean the disinfectant/trace elements deposits, introduce into them clean water and make an Trace elements-session and a Cleaning-session . NOTE: It is important to revise the connections of the water lines every 2 weeks approximately, adjusting the equipment if it were necessary. For the water filtering system, follow the maintenance established for it. See change of cartridges of the filter. As you can read in this section, the maintenance and possible substitution depend on the type of water, volume of filtered water and time of use. The estate of the emergency battery will be checked every 3 months and when there is a failure of the electric net.

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WARNINGS The following messages have been included in the Use Guide to warn the healthcare personnel using this equipment of certain restrictions and possible dangers. The therapist must stay with the patient in every moment. The handling or misuse of the electric components can provoke electric discharges. This equipment is not gas-proof. That is to say, the performance of the equipment in a gasified environment can provoke its combustion.

Do not bow the equipment more than 5 degrees in order to avoid stability problems and prevent it from falling. Adjustments or handling by no authorized personnel can provoke damage to the patient which cancels any guarantee or liability. Read this guide before using the equipment. Do not connect any other electric device with multiple connectors to the same connexion of the equipment. For full information about the electric and hydraulic installation on the premises consult your electrician and plumber beforehand. Do not connect any of the water lines, outlet of wastes or electric line to any other part of the equipment or among them. This might cause damage to the equipment and its performance. Do not ever leave the equipment with the lines of water open without supervision by a professional. Close always the inlet of water when you are not using the equipment. We are not responsible for the damages for the water that may be spilt if there is an escape when the equipment is not being watched by someone. In the case of water escape close immediately the water entrance. When we are going to make a session, the trace elements and disinfectant deposits must always have a minimum quantity so that the message “No Trace Elements/disinfectant” does not show (even in the case of session without trace elements). When we change the battery of the remote control this one must be reprogrammed this way : Push the key to the left on the second row of keys. It will go on and off. Push till it stays off and push once the key to the left on the same row (it goes on and off), a second time (the red light goes on and off again) and a third time ((it on and off again).Check that the programming has been made. If not, repeat the process.

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PROBLEM SOLVING

TURN ON If when pushing the main switch no message appears on the screen : 1. Check that the connexion to the general net is correct. 2. Check if the fuses are damaged. If so, replace them with the ones delivered together with the machine. If

further problems persist, call the Transcendencias Comerciales S.L. technical department. 3. If the main switch is lighted up and there are no messages, consult Transcendencias Comerciales S.L.

technical department. PREPARATION 1. Preparation button without light. If the Preparation button works but does not light up, the lamp of the

button must be substituted with the spare one supplied with the machine. 2. If pushing Preparation the Preparation session does not start and the message telling us does not appear ,

consult Transcendencias Comerciales S.L., technical department. 3. If, selecting Temperature or Time of the session, the machine does not let modify these parameters,

consult the technical department of Transcendencias Comerciales S.L. IRRIGATION 1. Irrigation button without light. If the button works but does not light up, its lamp must be substituted with

the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department.

2. If the irrigation process does not work it can be due to : The alarm temperatures below 22ºC or above 40ºC have been reached. Finish the session and consult the Transcendencias Comerciales S.L. technical department. Excessive pressure : - Check that the speculum has been properly introduced into the patient’s sphincter. - Check if the circuit from the speculum to the visor tube is blocked. - If the problem has not been caused by any of these, consult the Transcendencias Comerciales S.L. technical department.

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If we do nor reach the selected temperature during irrigation, finish the session and consult the Transcendencias Comerciales S.L. technical department. If when trying to select Temperature or Time of session, the machine does not let us modify these parameters, consult the Transcendencias Comerciales S.L. technical department. If the problem is not due to any of the previous elements, contact Transcendencias Comerciales S.L. because it might be due to internal failure of relays, electrovalves, etc. FAST DISCHARGE, SLOW DISCHARGE, FILLING If any of these buttons does not light up, its lamp must be substituted. Consult the Transcendencias Comerciales S.L. technical department. If any of these functions does not work properly, finish the session and consult the Transcendencias Comerciales S.L. technical department. TRACE ELEMENTS If this button does not light up, its lamp must be substituted. Consult the Transcendencias Comerciales S.L. technical department. If once Trace elements pushed we do not see that they are being introduced in the irrigation line, check the established flow in the Flow Regulator and the Trace elements Introduction board. If the flow is correct, finish the introduction of trace elements and consult the Transcendencias Comerciales S.L. technical department. OZONE If the button works but does not light up, its lamp must be substituted with the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department. If once Ozone pushed and the message “Ozone Activated” does not appear on the screen finish the introduction of ozone and consult the Transcendencias Comerciales S.L. technical department. SAMPLES If the button works but does not light up, its lamp must be substituted with the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department. If pushing Samples the outlet of samples does not open (or Filling does not get activated first) finish the session and consult the Transcendencias Comerciales S.L. technical department. If there were any dripping through the outlet of samples, we must substitute the valve of the outlet of samples. Consult the Transcendencias Comerciales S.L. technical department.

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CLEANING If the button works but does not light up, its lamp must be substituted with the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department. If pushing Cleaning the cleaning sequence does not start and the Cleaning started message does not appear on the screen, do not make further sessions and consult the Transcendencias Comerciales S.L. technical department. If pushing Cleaning the machine made a serial of sweepings and rinces of the visor tube, apart from activating in different sequences Fast Discharge, Filling and Samples (see cleaning instructions) , if any of these is not made, do not make further sessions and consult the Transcendencias Comerciales S.L. technical department. STOP If the button works but does not light up, its lamp must be substituted with the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department. If pushing Stop it does not appear on the screen the message of Session Finished and it does not ask for Cleaning started, do not make further sessions and consult the Transcendencias Comerciales S.L. technical department. CONTROL BUTTON If when trying to select Temperature or Time of session, the machine does not modify this parameter pushing the control button, consult the Transcendencias Comerciales S.L. technical department. TIME, LITERS AND TEMPERATURE BUTTONS If any of these buttons does not light up, its lamp must be substituted with the spare one provided with the machine. Consult the Transcendencias Comerciales S.L. technical department. If when pushing anyone of them the screen does not show the selected information about Time, Liters or Temperature, finish the session and consult the Transcendencias Comerciales S.L. technical department. The same if it is not possible to modify the Time and Temperature parameters. CONTRASTS If the button works but does not light up, its lamp must be substituted with the spare one supplied with the machine. Consult the Transcendencias Comerciales S.L. technical department.

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If when pushing Contrasts the screen does not show the messages corresponding to the contrasts session or if the machine does not let modify the parameters, finish the session and consult the Transcendencias Comerciales S.L. technical department. Once the contrasts session parameters selected, if when pushing contrasts once more the values of temperature and time of change of temperature on the screen is not the one that we had selected, finish the session and consult the Transcendencias Comerciales S.L. technical department. TEMPERATURE If the screen indicating the temperature does not show any data or if it can be read correctly it must be replaced. For it, consult the Transcendencias Comerciales S.L. technical department. PRESSURE If it does not show any values during the session, the manometer must be substituted. For it, consult the Transcendencias Comerciales S.L. technical department. When, in spite of overdoing 100 mbar or 1.42 psi, Fast Discharge does not get activated, the pressurestat must be adjusted. For it, consult the Transcendencias Comerciales S.L. technical department. METERS If any of Time, Liters or Sessions meter does not show any value, consult the Transcendencias Comerciales S.L. technical department. VISOR TUBE If it does not get completely full during the filling process, consult the Transcendencias Comerciales S.L. technical department. WATER ESCAPES If once connected and opened the water line we observe water escapes, close the key and disconnect the equipment from the electrical net in order to check the piece where the escape is originated. Finish the session and consult the Transcendencias Comerciales S.L. technical department.

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TECHNICAL CHARACTERISTICS - 220 V / 50 Hz or 110 V / 60 Hz - Consumption 155 VA - Control and measure of temperature grad by grad - Water flow adjustment - Polypropylene filter - Polyamide tubes and valves, approved by the N.S.F. (National Sanitation Foundation, USA) - Water pressure automatic security control during irrigation : 100 mbar / 1.42 psi (high sensitivity pressure stat). - Temperature automatic security control : 40ºC or 104ºF

SESSION PARAMETERS - 0-100 liters or 0-37.5 gallons per hour. Adjustable flow regulator (session : between 68 and 80 liters or between 16 and 19 gallons) - Pressure between 0 and 100 mbar or 0 and 1.42 psi. - Temperature between 25 and 37ºC or between 77 and 98ºF

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SECURITY SYSTEMS The HC-3000 LUXE is controlled by two automatic security systems. When the alarms get activated (the light of the irrigation button will flash), press irrigation until getting into the session again. (With pressure alarms press once, with temperature alarms press twice) 1.- The maximum pressure is 100 mbar or 1.42 psi. If pressure exceeds this value, the machine does not allow irrigation and it activates Fast Discharge.

IRRIGATION SESSION EXCESSIVE PRESSURE MAX 100mBAR

TIME REMAINING XX MINUTES DECILITERS INTERVAL XX DECILIT

2.- Maximum temperature: 40ºC or 104ºF . Minimum temperature : 22ºC. If temperature exceeds from these limits, the machine does not allow irrigation and it activates Fast Discharge.

IRRIGATION SESSION EXCESSIVE TEMPERATURE > 40 GRADS

TIME REMAINING XX MINUTES DECILITERS INTERVAL XX DECILIT

IRRIGATION SESSION

INSUFFICIENT TEMPERATURE <22 GRADS TIME REMAINING XX MINUTES

DECILITERS INTERVAL XX DECILIT

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INTRODUCTION OF TRACE ELEMENTS, SALTED WATER AND OTHER THERAPEUTIC SOLUTIONS

If we want to introduce Trace elements or other therapeutic solutions only during the irrigation session, they must be poured into their corresponding deposit (with a one liter capacity), placed on the upper part of the machine. Pushing Trace elements, the elements in the deposit will get mixed up with the irrigation water. The volume of water introduced will depend upon the selected flow of water according to the following board :

Selected Flow Trace elements per Pulsation > 50 0 40 150 30 175 20 200 10 225 0 250

The introduction of these elements gets automatically deactivated. It can be connected as often as wished until the desired amount of trace elements has been introduced.

INTRODUCTION OF OZONIZED WATER If, during irrigation, we want to introduce ozone, we must push Ozone. This way, the machine that produces ozone will start working and it will ozonize the water that will be used in irrigation. To deactivate it, push Ozone again. During the process the following message will appear on the screen :

IRRIGATION SESSION OZONE ACTIVATED

REMAINING TIME : XX MINUTES DECILITERS INTERVAL : XX DECILIT

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ASSISTANCE GENERAL MANAGER/ GENERAL MANAGER Jorge Echevarría Tel: (34) 943 224 360 Fax: (34) 943 224 275 Parque Empresarial Zuatzu C/Zubiberri, 31. Edificio Urumea. Finca 1. Planta Baja. Local 1 20018 San Sebastián (Guipúzcoa) e-mail: [email protected] // web: www.transcomsl.com SALES DEPARTMENT/ DEPARTAMENTO DE VENTAS o Tel: (34) 943 224 360 Fax: (34) 943 224 275 Parque Empresarial Zuatzu C/Zubiberri, 31. Edificio Urumea. Finca 1. Planta Baja. Local 1 20018 San Sebastián (Guipúzcoa) e-mail: [email protected] // [email protected] web: www.transcomsl.com TECHNICAL DEPARTMENT/ DEPARTAMENTO TECNICO Tel: (34) 943 224 360 Fax: (34) 943 224 275 Parque Empresarial Zuatzu C/Zubiberri, 31. Edificio Urumea. Finca 1. Planta Baja. Local 1 20018 San Sebastián (Guipúzcoa) e-mail: [email protected] // web: www.transcomsl.com ACCOUNTING DEPARTMENT/ DEPARTAMENTO DE ADMINISTRACION Tel: (34) 943 224 360 Fax: (34) 943 224 275 Parque Empresarial Zuatzu C/Zubiberri, 31. Edificio Urumea. Finca 1. Planta Baja. Local 1 20018 San Sebastián (Guipúzcoa) e-mail: [email protected] // web: www.transcomsl.com EXPORT DEPARTMENT/ DEPARTAMENTO DE EXPORTACION Tel: (34) 943 224 360 Fax: (34) 943 224 275 Parque Empresarial Zuatzu C/Zubiberri, 31. Edificio Urumea. Finca 1. Planta Baja. Local 1 20018 San Sebastián (Guipúzcoa) e-mail: [email protected] // web: www.transcomsl.com

THIS DEVICE HAS TWO YEAR GUARANTEE. IN SPARES AND LABOUR.

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SERVICE Dear owner of the most precise colon-hydrotherapy on the market nowadays. We want to make you know how much we do appreciate your confidence apart from our completely attention and technical support to solve all our clients’ needs in the field of the colon-hydrotherapy. As we already pointed out in the Guarantee-section, you will always have our technical support and spare parts during the equipment’s whole life. We will do everything possible to answer to your questions as soon as they arrive and you let us know. To make this task easier, we encourage you to contact us by telephone indicating the problem and following this squeme: - Which problem seems it to be - Have you checked that the drainage system is not blocked or does not have any escapes - If there are escapes, where - Have you checked the filters system - Is the stretcher at the correct height - Is the water inlet open and the connexions well adjusted - Is the equipment connected to the net - Have you tried to find the source of the problem These are some of the most usual questions that may help you and us to find the source the problem. Anyway, whatever your problem is, big or little, please contact us as soon as possible in order to have the equipment working correctly. See the Problem-Solving-Guide for further information.

SALES AND AFTER-SALES SERVICE COLON-HYDROTHERAPY

TRANSCENDENCIAS COMERCIALES, S.L.

PARQUE EMPRESARIAL ZUATZU C/ Zubiberri 31, Edificio Urumea Finca 1 – Planta baja Local 1

20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275

E-MAIL: [email protected] // www.transcomsl.com

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WARRANTY CERTIFICATES We the undersigned, warrants all equipment to be free from defects in material and workmanship for a period of two years form the date for delivery, provide the equipment is installed and operated according to the manufacturers instructions. Our obligation under this warranty is limited to the repair and/or replacement of any defective part or correcting any manufacturers defects, without charge during the warranty period if the manufacturers/seller confirms the existence of such defects. The owner/owners obligation is to notify the seller/manufacturer via telephone, and follow up in writing of any problems thought to be the result of manufacturing error. Everyday wear and tear from use is not covered under this warranty. Owner/Owners of the colonic equipment will always have the right to free technical support for the life of the equipment and access to parts and accessories as long and the seller/manufacturer remains in business. Cartridges are needed to be changed either every 75 sessions or every six months, if not Transcendencias Comerciales will not be responsible of the device . This will depend on the type of water in the area where the machine is installed Our option to repair and/or replacement will be (F.O.B.) Freight on Board to Transcendencias Comerciales S.L., Spain. Or if possible in certain locations where seller/manufacturer can fly into certain cities, at the seller discretion will fix or replace parts on the owner/owners premises. Therefore, there will be no compensation for transportation expenses unless the problem occurs during the one year unlimited warranty and the defect is manufacturers error. We shall pay one way shipping. We will not be liable for any loss of business revenue, consequential damages or expenses occurring directly or indirectly from the use of the equipment covered under this warranty. Note: Obvious abuse, improper use and tampering with gauges, settings and etc., by unauthorized personnel, or without sellers/manufacturer supervision will void this warranty. Note: All installation of the plumbing and electrical work to prepare for the arrival of the colonic machine and the Water Treatment System must be installed by a licensed plumber and electrical contractor. Also they must meet the specifications set by Transcendencias Comerciales S.L. Colon Hydrotherapy. This is to ensure 100% efficiency for the colonic equipment.

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Costumer’s

Name

Type of equipment

and Voltage

Serial

Purchase date

Establisment

stamp

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- DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard ROCKVILLE MD 20850 (USA) 510(K) Number K 970482 - MINISTERIO DE SANIDAD Y CONSUMO Subdirección General de Prestaciones y Evaluación y de Tecnologías Sanitarias MADRID (SPAIN) Nº 109318 - MINISTERIO DE INDUSTRIA Y ENERGIA Dirección General de Electrónica y Nuevas Tecnologías MADRID (SPAIN) Nº 204901 - RWTÜV Anlagentechnik, GmbH Steubenstraße, 53. D-45138 ESSEN (GERMANY) Nº 2630/96 - LABEIN - Centro de Investigacion Tecnologica Cuesta de Olaveaga, 16 48013 BILBAO (SPAIN) Nº 9701B31-44-TI-3 - U.G.C. - GAIKER - Centro de Transferencia Tecnologica Parque Tecnologico Ed. 202 48170 ZAMUDIO (SPAIN) Nº T-97-9079

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Dear Customer: Thank you for ordering the merchandise enclosed in this package. Before leaving our warehouse it was inspected by the Supervisor. Please inspect the contents thoroughly for damage or errors in fulfilling your order. If you find there is a problem, please send us the information requested below: If merchandise was damaged in shipping, take the following steps: 1. If possible, note visible damage to cartons and the exent of damage before signing shipping documents. 2. Save all original packing materials and containers for inspection by the carrier until the claim is settled. 3. Contact our costumer service department directly for assistance. DO NOT RETURN any merchandise without our prior a authorization. We will contact you inmediately upon receipt of this notice. Product(s) ( )arrived damaged: ( )order incorrect ( ) other: Product(s) Involved - please specify cat. no., qty, and description: 1. ____________________________________________________________________ 2. ____________________________________________________________________ 3. ____________________________________________________________________ DESCRIBE THE PROBLEM OR ERROR. If the item is damaged, indicate the exact damage or error and clearly the corrections desired: ___________________________________ ______________________________________________________________________ _____________________________________________________________________ Invoice# or date or Invoice:_____________ Phone No. ( ) ___________________ Customer Name:___________________________________ Address: ___________________________________ City:___________________Sate:____________________Zip:___________________ Shipping Address (If different from above):____________________________________ _____________________________________________________________________

Return to: TRANSCENDENCIAS COMERCIALES, S.L

PARQUE EMPRESARIAL ZUATZU C/ Zubiberri 31, Edificio Urumea Finca 1 – Planta baja Local 1

20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275E-MAIL: [email protected] // www.transcomsl.com

TRANSCENDENCIAS COMERCIALES, S.L

PARQUE EMPRESARIAL ZUATZU. C/ Zubiberri 31, Edificio Urumea Finca 1 Planta Baja Local 1 20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275

E-MAIL: [email protected] // www.transcomsl.com

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PACKING LIST AND DEVICE LABEL

A list of items below are provided with your colonic machine upon arrival. These items are to complete the installation and set up for the operation of the colonic machine. Upon arrival you will have everything included for basic start up, all items are preassembled and are not in a kit form. They require simple connections to your cold and warm water supply and drainage lines. Other accessories can be added which are discussed in other sections of this manual. 1) CLEANING CUP 1 UNIT 2) FUSE 5-A 2 UNITS 3) FUSE 10-A 2 UNITS 4) CONTROL REMOTE DEVICE 1 UNIT 5) BULB FOR ROUNDED SWITCH 3 UNITS 6) FILTER KEYS 1 UNIT 7) GREEN LED 3 UNITS 8) 32 mm PVC FLEXIBLE PIPE 1 M. 9) POLYAMIDE PIPE 10mm 2 M 10) SPIGOT CONNECTOR PVC TUBE 6mm 2 UNITS 11) RACOR CONNECTER TUBE 10 mm-1/2” 2 UNITS 12) POLYPROPILENE FILTER WITH HOUSING 1 UNIT 13) PROCESS MANUAL 1 UNIT

TRANSCENDENCIAS COMERCIALES, S.L

PARQUE EMPRESARIAL ZUATZU. C/ Zubiberri 31, Edificio Urumea Finca 1 Planta Baja Local 1 20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275

E-MAIL: [email protected] // www.transcomsl.com

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HIDROTHERAPY OF THE COLON

“HC – 3000 LUXE” INSTALLATION HANDBOOK

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TRANSCENDENCIAS COMERCIALES, S.L.

e-mail: [email protected] www.transcolm.com

COLON EQUIPMENTS

TRANSCENDENCIAS COMERCIALES, S.L. PARQUE EMPRESARIAL ZUATZU

C/ Zubiberri 31, Edificio Urumea Finca 1 – Planta baja Local 1 20018 SAN SEBASTIAN-GIPUZKOA Tel.:34 943 224360 Fax.:34 943 224 275

E-MAIL: [email protected] // www.transcomsl.com HC – 3000 LUXE

WEIGHT 90 KG. / 198.3 LBS. DIMENSIONS 1565 x 820 x 585 mm / 61.61 X 32.28 X 23.03 inches

NON-STERILE QUANTITY 1

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INSTALLATION

The installation of the colonic machine, and the Water Treatment System must also be installed by a representative of Transcendencias Comerciales S.L. or a licensed plumber and must follow set installations/instructions. If this is not complied with and receipts keep, of the installation company and charges by that company. If these above items are not complied with, then this does void any and all warranties on the colonic machine and the Water Treatment System. EQUIPMENT MADE: TRANSCENDENCIAS COMERCIALES S.L. MODEL: HC-3000 LUXE____________________________________ SERIAL NUMBER: ___________________________________ VOLTAGE: � 110 V / 60 Hz � 220 V / 50 Hz SELLER: ___________________________________________ Signed DATED:____________________________________________ BUYER:____________________________________________ Signed DATED: ___________________________________________

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SHIPPING

All shipping will be arranged between the client and the manufacturer, which will best suit the needs of our clients. We use a wide variety of companies. Usually we ship by air. The equipment is packed very carefully to avoid damage to the cabinet and the internal parts, sometimes caused by shipping. We use the best means of packing and take extra precautions to avoid shipping damage. The equipment is insured by the shipper and machine should be carefully gone over after delivery for any infractions should be reported to the manufacturer immediately. So the damage can be reported to the shipping company. Note: Due to being moved around and bumps in the shipping process, water leaks may occur, but are rare. Sometimes temperatures may play a factor in leaks, but would also be very rare and would have to go from one temperature extreme to the other. Please check water lines for leaks inside of the machine and re-tighten as necessary.

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ESSENTIAL TECHNICAL REQUIREMENTS FOR THE FITTING-UP AND PROPER PERFORMANCE OF THE HC-3000 LUXE DEVICE

TECHNICAL REQUIREMENTS The pre-installation must be carried out by a plumber there where the machine is going to be installed. These are the requirements : - Cold water inlet with a 1/2” gas thread to which a 1/2” gas thread flexible will be added. - Plug cock placed in the cold water tube that will be placed between the tube and the flexible. - Warm water inlet with a 1/2” gas thread to which a 1/2” gas thread flexible will be added. - Plug cock placed in the warm water tube that will be placed between the tube and the flexible. - 32mm- tube that will be connected to the sewage outlet. - Siphon for the connexion of the own drainage to the sewage pipe. NOTE : The siphon must be placed as low as possible. Always below to the drainage tube connexion. If not, the machine can not work properly. - Two constant pressure regulators gauged at 2 Bar, that will be placed in the cold and warm water pipes. - An electric thermo with a minimum capacity of 60 liters NOTE : The following can not be installed: - low pressure accumulators - instant low pressure heaters - butane or gas thermos - A plug that will be placed for security reasons minimum one meter from the vertical from the place where the machine is going to be installed. IMPORTANT : The plug must have ground connexion. The place where the machine is going to be installed must have a 30mA-high sensitivity differential switch. ELECTRICAL REQUIREMENTS The voltage must be 220 V / 50 Hz NOTE : If your electrical house connection is different from the one indicated, contact the Transcendencias Comerciales S.L. technical department to get the equipment adjusted. PRESSURE REQUIREMENTS The constant pressure of the cold and warm water nets must be 2 Bar and incorporated to each cold and warm water pipes a constant pressure regulator. TEMPERATURE REQUIREMENTS The internal memory of this device is set to the safety level of 40ºC or 104ºF. If this temperature is exceeded the safeties will cut in and the irrigation system will be shut down.

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STRETCHER REQUIREMENTS - The stretcher must be 80 cm high. - The stretcher must always be placed to the left of the machine. IMPORTANT NOTES Before connecting the equipment to the cold and warm water inlet pipes we must make the water flow through the cold and warm water pipes until the solid particles that may have remained sice the preinstallation disappear. We recommend to put delimers in the cold and warm water pipes to the entrance of the equipment there where the concentration of lime in water is high. In those places where the temperature of the cold water supplied is under 15ºC we need warm water supply at 60ºC plus the difference between 17ºC and the temperature of the cold water supply. Warm water temperature = ( 60 + ( 17 - Cold Water Temperature) ) ºC If any of these requirements is not met, the final preparation will not be properly accomplished. MACHINE REGULATOR (TO BE MADE DURING THE INSTALLATION) (Necessary under warm and cold water supply temperatures different from 60ºC and 20ºC < TEMPERATURE <15ºC ) Steps to be followed : 1º Remove the upper rear cover of the machine (unscrew) 2º Load with 5 V of direct current the regulating proportional valve. For it, disconnect the corresponding outlet of the electronic card and connect the 5 V to the air connector of this outlet. 3º Open the cold and warm water plug cocks of the water supply to the machine. 4º Turn on the main switch of the machine and put it into preparation. 5º Regulate the warm water regulator (twisting it towards + opens it and twisting it towards - closes it) until the temperature display shows and maintains readings of 30-31ºC for about 5 minutes. 6º Disconnect the loading of 5 V from the air connector of the outlet of the electronic card and connect the connector to this card. 7º Replace the upper rear cover of the machine.

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TRANSCENDENCIAS COMERCIALES, S.L. COLON HYDROTHERAPY

“HC – 3000 LUXE”

APPROVALS

0843

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TRANSCENDENCIAS COMERCIALES, S.L. COLON

HYDROTERAPHY

SPECULUMS

HYDRO-KIT

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HYDRO-KIT

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INDEX HC-3000 LUXE HANDBOOK • Introduction and general information 1 • Indications for Colon-Hydrotherapy 3 • Counter-indications for Colon-Hydrotherapy. 3 • Clinical setting 3 • Target patients 3 • Components 4 • Characteristics of the HC-3000 LUXE 5 • List of messages appearing on the digital screen 11 • Step by step description of a session 14 • Samples 17 • When the session is finished 17 • Instructions for the disinfection and maintenance of the HC-3000 LUXE 18 • Recommended disinfectant 20 • Cleaning maintenance of the inside of the equipment 21 • Change of the cartridge of the filter 21 • Maintenance 22 • Warnings 23 • Problem solving 24 • Technical characteristics. Session parameters 28 • Security systems 29 • Introduction of Trace elements, salted water and other therapeutic solutions 30 • Introduction of ozonized water 30 • Assistance 31 • Service 32 • Warranty Certificates 33 • Packing list and device label 36 • Installation Handbook 39 • Essential technical requirements for the fitting-up and proper performance of the HC-3000 LUXE 41 • Approvals 44 • Speculums and Dispo-kit 53 • Index