“HC – 1 NEW” PROCESS MANUAL 0843 HC-1manual_en.pdf · 2016. 7. 14. · Dear Customer: Before...

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“HC – 1 NEW” PROCESS MANUAL 0843

Transcript of “HC – 1 NEW” PROCESS MANUAL 0843 HC-1manual_en.pdf · 2016. 7. 14. · Dear Customer: Before...

Page 1: “HC – 1 NEW” PROCESS MANUAL 0843 HC-1manual_en.pdf · 2016. 7. 14. · Dear Customer: Before you use the HC-1 NEW machine for the first time, read thoroughly the manual with

“HC – 1 NEW” PROCESS MANUAL

0843

Page 2: “HC – 1 NEW” PROCESS MANUAL 0843 HC-1manual_en.pdf · 2016. 7. 14. · Dear Customer: Before you use the HC-1 NEW machine for the first time, read thoroughly the manual with
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Dear Customer: Before you use the HC-1 NEW machine for the first time, read thoroughly the manual with the specifications and directions for use, so that you know everything about the correct working and installation of the machine.

“HC – 1 NEW” The HC-1 NEW is brand new 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 cleanse the large intestine in complete safety.

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This equipment is designed and built with the following in mind: 1. Patient´s Safety System with full pressure & temperature regulation High-precision, highly reliable pressure gauge & thermostat Brass, stainless steel & PVC connections, non-toxic Teflon and Tygon hoses to prevent water contamination. Materials: steel, stainless steel, Tygon, brass, Perspex and PVC. Flow cut-off if maximum or minimum temperature is exceeded. 2. Easy Operation Easily visible & accessible controls Instructions & labels in Spanish, German, French, English, Italian, Russian and Portuguese Automatic cleaning system Hermetic, odour-free drainage system 3. Economy Sterilisation via liquid Low maintenance Low consumption Easy installation Designed 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 indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

CONTRAINDICATIONS FOR COLON HYDROTHERAPY Severe Cardiac Disease (uncontrolled Hypertension or Congestive Heart Failure) Aneurysm GI Hemorrhage / Perforation Severe haemorrhoids Carcinoma of the Colon or Rectum Fissures / Fistulas Advanced Pregnancy Abdominal Hernia Recent Colon or Rectal Surgery Renal Insufficiency Abdominal Surgery Intestinal Perforations Pregnancy

INTENDED USE STATEMENT The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination

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

PATIENT POPULATION The patient population would include both male and female of all age groups, with the supervision of the physician. This is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination. Only adult patients are to be treated with this device.

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CHARACTERISTICS OF HC-1 NEW ARACTERISTICS OF HC-1 NEW GENERAL SWITCH (1)GENERAL SWITCH (1) Main switch. Set to (1) to switch on and (0) to switch off the machine. PRESSURE GAUGE (2) This device displays the water pressure in irrigation. This manometer measures the pressure inside the patient’s colon when the irrigation is being carried out. It is recommended to set the pressure at 150 mbar (2.17 psi) during the therapy. It can be raised or lowered by the customer. Nevertheless, from then on Transcendencias Comerciales S.L. will accept no liability for injury to patients or damage on the machine. FLOW RATE REGULATOR (3) It controls the volume of water per hour and therefore regulates the quantity of water injected into the patient, and at what pressure. At the bottom of the water flow regulator there is a round control. Turning this piece clockwise the water income diminish so lower pressure will be set. Turning this piece anti clockwise more water comes in so higher pressure will be set. GENERAL CONTROL (4-5) - The general valve to open and shut off water faucet (4) controls how much water passes through the machine. - The temperature regulator (5) has a numbered scale for easier adjustment. The temperature set should be

shown on the upright control. This control raises or lowers the water temperature as required. A manual is supplied with the component so that any misadjustment can be corrected.

- We can correct the position of the control temperature of the Thermostatic valve (5) if there is any difference between the temperature of the temperature gauge (6) and the temperature indicated by the thermostatic valve. To readjust it, unscrew the cover of the control turning it anti clock wise (holding the control so that it is only the cover that moves) and with a screwdriver unthread the fixing screw to the hub cap to the spindle. The spìndle of the valve has some grooves that fix perfectly with the grooves of the control. Pulling backwards of the control and turning it left or right at the same time and inserting them in the control of the spindle, you can read just the temperatures and adjust it to the one indicated by the temperature gauge (6). Once the temperature has been adjusted, adjust the fixing screw of the hub cap and replace the cover of the control.

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DIGITAL THERMOSTAT (6) It is a digital indicator showing the temperature programmed on the temperature regulator (5). The recommended maximum temperature is 40 ºC (104ºF) and the minimum 25ºC (77ºF). The internal memory of this device is set to the safety levels of 40 ± 1°C and 22± 1°C. If these temperatures are exceeded the system will cut in and the irrigation system will shut down for safety reasons. A manual for this item is included so that corrections can be made if it slips out of adjustment. CONTROL VALVE; PREPARATION - IRRIGATION - LOCKED (7) Three way valve to prepare the machine and to control the water flow and the development of the session. - PREPARATION: In this position water circulates until the selected temperature and flow rate are reached. - IRRIGATION: Once the set levels are reached, move to this position to start therapy. - LOCKED: This position stops the water flow. DISINFECTANT VALVE (8) This lets the disinfectant stored in the disinfection deposit (10) to clean the device. See machine cleaning instructions. CLEANING VALVE (9) When the session is finished, turn this valve to clean the drainpipe circuit of all waste and germs. This cleans the inner circuits of the device. See machine cleaning instructions. DISINFECTION DEPOSIT (10) This deposit holds the disinfectant used to clean the internal parts of the device thoroughly. See machine cleaning instructions.

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INSTRUCTIONS FOR THE SETTING OF THE THERMOSTAT

To set up the thermostat (Only if the thermostat has been deprogrammed and always under supervision of Transcom technical team):

1. Switch on the device and wait until the auto-test is done. 2. Keep the button “p” pressed until you enter the programme planning. 3. Press either up or down arrows (^ or v) until the word “Conf” is on the display. 4. Press “p”. 5. Using the arrows, introduce the number “381”. 6. Press “p”. 7. Search “InP” and press “p” 8. Search “dp” and pres “p”, then introduce “1” and press “p”. 9. Keep “⇑” pressed until it appears “InP” 10. Using the arrows, look for “⊃ SP” and press “p” 11. Using the arrows, look for “ ΠSP” and press “p” 12. Put in “1” and press “p” 13. Look for “SP1” and press “p”, put in “22” and press “p” 14. Look for “SPLL” y press “p”, put in “20” and press “p” 15. Look for “SPHL” and press “p”, put in “40” and press “p” 16. Keep pressed “^ “until “⊃ SP” is on the display. 17. Look for “rEG” and press “p” 18. Look for “Cont” and press “p” 19. Select “OnFS” and press “p” 20. Keep pressed “^ “ until “rEG” is on the display. 21. Look for “Out” and press “p” 22. Look for “O2F” and press “p” 23. Select “AlnO” and press “p” 25. Keep pressed “^ “ until “Out” is on the display. 26. Look for “AL1” and press “p” 27. Look for “Alit” and press “set” 28. Look for “HiAB” and press “set” 29. Look for “AL1” and press “set”. 30 Put in “40” and press “set”. 31 Keep pressed “^ “ until going out of the temperature

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CONTROL VALVE (11): FILLING - QUICK DISCHARGE It manually engages the Filling and Discharge functions. - FILLING: In this position the control allows the water to enter into the colon through the water line and rectal

nozzle, until the colon is filled with water. The Filling must be also stopped when the intra-intestinal pressure exceeds 150 mbar (2.17 psi) or because of the patient advise.

- QUICK DISCHARGE: Set the control at this position at the request of the patient when the colon is full of

water. In evacuation the waste is dragged along the outlet tube and can be observed in the viewing tube. In this position the control allows water and waste out of the colon through the waste outlet (18).

RESIDUES INLET(12) It is a connection point on the machine which is used for the following operations: - Waste removal: fit the removal tube to carry out therapy. - Cleaning the machine: fit the disinfectant flex (15) after each session to clean the unit. The residues inlet is a male connector to which the components mentioned before are fitted, the waste hose during the therapy and the flexible hose during the disinfection. IRRIGATION OUTLET (13) This is a connection point on the machine. One end of the kit´s water line must be connected to it during the therapy. A disposable speculum kit consists on the following components: - 1 Rectal nozzle - 1 Obturator - 1 Thin plastic tube (1500 mm Water line) - 1 Thick plastic tube (1300 mm Waste hose)

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CLEANING WATER OUTLET (14-15) The Disinfectant Flex (15) is connected to the cleaning water outlet (14) on the machine to clean it. The water and the disinfectant used in the disinfection process go through this flexible hose. Once the therapy is finished and the patient is not connected to any components, the flexible hose must be reconnected to the waste inlet. VIEWING TUBE (16) Transparent Perspex tube for viewing the waste removed from the patient during the session. A light is built in to facilitate observation. FILTERS (17) Two polypropylene filters are incorporated to filter the water before it is injected into the patient. This is important for the proper running of the machine as it avoids the build up of elements present in the main water supply which could damage the components. These filters are connected to the hot and cold water pipes and to the machine. U.V. LAMP (30) After flowing through the activated charcoal filters, the water is exposed to ultra-violet light, which ensures the elimination of bacteria. RESIDUES OUTLET (18) The drainage tube should be connected to this connection point on the machine. PLUG AND MAINS CABLE (19-21) Socket (19) on the machine is to connect the plug (21) supplied. FUSES (20) The machine is protected by four fuses very easy to change. SOCKET (22) The main socket should be at least 1 m from the machine on the left hand side.

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IDENTIFICATION PLATE (23) All these machines carry an ID plate with the following data:

- Manufacturer's name - Model - Rated voltage - Frequency - Class of protection - Power - Applied part - Type of main connection - Type of conductor lead - Date of manufacture - Serial number

METAL SUPPORT AND GLASS BOTTLE (24, 25, 26) Connection for the support (25) on the machine is for the metal support (26) and the glass bottle (24) through which trace elements, salt water and therapeutic solutions can be introduced during the session. INTRODUCTION OF TRACE ELEMENTS, SALT WATER, THERAPEUTIC SOLUTIONS, OXYGEN AND OZONE (02, 03) There are connection points to introduce trace elements, salt water or therapeutic solution, and oxygen (02) and ozone (03) during the session. CROMOTHERAPY (27) There are five buttons for making Cromotherapy. Pressing each button you can choose each colour the Therapist want to give into the patient through the water.

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DETAILED DESCRIPTION OF A SESSION Warning: The therapist must remain with the patient during the session. 1. Open the water stop-tap. 2. Switch on the general switch (1). 3. Set the Water Faucet (14) to maximum (large point). 4. Select the working temperature at the Temperature Regulator (5) turning it and check on the thermostat (9)

that this temperature is reached. 5. Set the control valve (7) to "Preparation"

NOTE: The control valve is a three way valve (for Preparation, Locked and Irrigation). This valve controls the direction of the fresh water to the Irrigation Outlet, if Irrigation position is chosen. When the Preparation position is selected, it diverts the water directly to the drainage system, thus allowing the water to warm up for the preparation of the equipment prior to a session. It allows the water to directly bypass the residues inlet and viewing tube and go directly into the drainage system. This position is used in the preparation of the equipment to allow the water temperature to rise or lower to the selected setting. Once all the steps have been completed and the temperature has arrived at the selected setting, the control valve is placed in the irrigation position. The third position is the closed position.

6. Select the working flow rate at the Flow Rate Regulator (3 ) turning the black control set at the bottom of

this regulator.

Using the control set at the bottom of the water flow regulator we can select the working flow rate by turning it: turning clockwise to decrease the amount of water or turning anticlockwise to increase the amount of water entering. The recommended rate is from 60 to 80 litters per hour (16 to 19 gallons), although it is possible to increase this amount without endangering the patient.

7. Using the inflow water line hose from the rectal nozzle kit, connect one end of the hose to the irrigation

outlet (13 ) and the other end of the hose to the inlet port (inflow water line hose connection port) of the rectal nozzle. Then connect the waste hose to the waste hose is connected to the waste line hose connection port of the rectal nozzle after the rectal nozzle is inserted into the patient and the obturator is removed, after step (8).

8. Insert the rectal nozzle into the patient and remove the obturator.

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9. Connect the waste hose to the rectal nozzle.

Both the inflow water line hose and waste line hose must be connected to the rectal nozzle manually. The inflow water line hose must be connected by inserting the hose over the appendage that protrudes from the Irrigation Outlet. The waste water line hose must be connected to the residues inlet by inserting the hose over the appendage which is a tapered fitting, to insure a water tight fit. The other end of the waste water line hose is connected to the rectal nozzle at the waste water line hose connection port, which is also a tapered fitting, to insure a water tight fit.

10. Set the control valve (7) to "Irrigation". This three way valve allows fresh water to enter the inflow water

line that is connected to the rectal nozzle. The water enters the rectal nozzle and leaves the rectal nozzle through the viewing tube, the device through the drain.

11. Set the control valve (11) to Filling and monitor the pressure-gauge to ensure that the pressure does not

exceed 150 mbar (2.17 psi).

When Filling is selected water is directed into the patient´s colon. This position stops the outward flow of the water to the drainage system. The fresh water supply is a continuous flow of water during the colonic process. This water fills the viewing tube and the waste water line hose to the rectal nozzle. Once filled, then the fresh water enters the colon. This process of Filling ensures no contamination from the viewing tube or waste hose into the colon.

When irrigation is selected the control valve (7) allows water to pass into the rectal nozzle, then down the waste water line hose into the residues outlet, view tube and drainage system. During this process the fresh water from the inflow water line hose is continuously running and helps to wash the stuff down the rectal nozzle and waste water line and residues inlet and view tube into the drainage system.

12. Once enough water has entered the patient’s colon, set the control valve (11) to quick Discharge.

The increase or decrease of water pressure inside the patient´s colon is displayed on the pressure gauge. More water implies higher pressure and less water implies lower pressure. The therapist will know when sufficient water is given by the following.:

- Patients response: The patient indicate to the therapist when they feel that the colon is full. The

therapist can select Discharge (the patient may remove the rectal nozzle themselves. This option is not dangerous).

- Pressure Display: On the pressure gauge, if the pressure is lower than 150 mbar (2.17 psi) the

therapy can continue by manually pressing Discharge. If the pressure exceeds 150 mbar (2.17 psi) the therapist must decrease the flow rate.

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13. Continue the session, alternating between "Filling" and "Quick Discharge" (11) 14. At the end of the session set the control valve (7) to Locked. 15. Disconnect the water line from the machine and then from the patient, in that order. 16. Disconnect the waste hose from the patient and from the machine and dispose of the entire kit.

The disconnection of this hose should be done in the following way:

a) First, the therapy must be finished. This means that neither water nor waste are inside the patient’s colon, so the water and the waste have passed through the waste (residue) inlet (having seen the water and waste through the viewing tube)

b) Remove the rectal nozzle from the patient’s sphincter by gently pulling. Then continue with the following instructions:

1º Disconnect the water line from the Irrigation outlet (13) by a gentle pulling action. 2º Disconnect the waste hose from the residues inlet (12) by a gentle pulling action.

Note: Once all the above elements have been removed, they are not to be used again and must be thrown out.

17. Disinfect the device.

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INSTRUCTIONS FOR DISINFECTION AND MAINTENANDE OF HC-1 NEW 1. After the waste hose is removed the flexible hose (15) is connected to the residues inlet (12). The connection

must be made in the following way: − In the ending of the flexible hose which is not connected there is a metallic appendage. The waste inlet

must be placed into this appendage (15) pushing it until the waste inlet is totally inside the appendage. Its flange must be pushed back to connect them.

− Once the piece nº 15 is connected, let the flange free to ensure the connection.

2. Before disinfection of the equipment, thoroughly clean, rinse with water to remove any remaining debris left in the assembly, opening the cleaning valve (9) and setting the Control Valve to Quick Discharge. Then close the cleaning valve and set the Control Valve to filling, open the disinfection valve so the disinfectant solution can enter the assembly. The total capacity of the assembly is 600 millilitres.

3. Open the disinfectant valve (8) till the Cleaning Tank empties, then return it to its initial position. 4. The disinfectant must remain in the assembly for a minimum of 10 minutes before removing it. To remove it

set the control valve (11) to Quick Discharge and allow all the contents to come out. 5. Once the disinfection process has been completed open the cleaning valve (9) to start the rinsing process and

remove any remaining disinfectant suds. This process must be repeated three times. The rinsing process is as follows: - Select Filling in the control valve (11). This allows the assembly to fill completely. The water will remain

rinsing for a minimum of one minute inside the assembly. - Select Quick Discharge to allow the water to flow to the waste drainage.

6. After the rinsing process has been completed a visual test needs to be done. So there is no residual disinfectant

remaining in the device. This is done in a visual way. That means once the disinfectant is in the visor pipe the necessary time for disinfection the visor pipe will empty and the therapist should proceed to clear with water the visor pipe, then with a simple visual test is enough to assure that there is no residual disinfectant remaining in the device.

If there is no residual disinfectant, disconnect the flexible hose (15) pulling back the ring around the flexible hose to disconnect it. Then pull the flex from the residues inlet (12).

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MAINTENANCE OF THE INTERNAL MACHINE CLEANING UNIT NTENANCE OF THE INTERNAL MACHINE CLEANING UNIT To keep the machine's internal cleaning circuit in perfect condition, every 10 sessions go through the usual cleaning process with clean water instead of disinfectant. To keep the machine's internal cleaning circuit in perfect condition, every 10 sessions go through the usual cleaning process with clean water instead of disinfectant.

CHANGING FILTER CARTRIDGES CHANGING FILTER CARTRIDGES 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. 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. 1. Twist to the right until the housing is completely free of its support. 1. Twist to the right until the housing is completely free of its support. 2. Unscrew the used cartridge twisting it to the right. 2. Unscrew the used cartridge twisting it to the right. 3. Put a new cartridge screwing it to the left until it is completely adjusted. 3. Put a new cartridge screwing it to the left until it is completely adjusted. 4. Put the housing again screwing it to the left until it is completely adjusted. 4. Put the housing again screwing it to the left until it is completely adjusted. IMPORTANT: Filters must be changed with new filters. Never reuse them.IMPORTANT: Filters must be changed with new filters. Never reuse them.

CHANGING OF THE U.V. LAMP

The U.V. lamp has a 7000 to 9000 hours life. We recommend to change the lamp once every three years. 1. Turn the machine off and close the water faucets. 2. Unscrew the grey milling thread of the side of the tube. 3. Take out carefully the old u.v. lamp. 4. Remove the supply wires of the lamp and take the O ring away. 5. Replace the used lamp for the new one, put the O ring and insert the lamp into the tube. 6. Pass the supply wires through the milling thread hole and connect them to the new lamp. 7. Screw the milling thread again. CAUTION: Do not look at the u.v. lamp when turned on. NOTE: Be aware that some water can be spilt in the step 2, so please, take care to put a bucket under the grey tube.

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APPLICATION OF TRACE ELEMENTS, SALT WATER, OXYGEN & OZONE

Any trace elements or therapeutic solutions to be supplied should be deposited in the glass bottle (24), which should then be connected to the trace element connector (27) by a plastic tube like the one used for irrigation. To provide oxygen or ozone, connect the relevant supply to the oxygen and ozone connector (28). 1. Set the control valve (7) to Preparation. 2. Reduce the flow-rate (3) to 20-30 l/h. 3. Set the control valve (7) to Irrigation 4. Set the control valve (11) to Filling. 5. Allow the viewing tube (16) and the rectal nozzle to fill. Once they are full, open the stop-tap on the glass

bottle (24) or the oxygen/ozone supply and allow the desired amount to flow out. 6. Check the pressure gauge (2) and press locked (7) before it reaches 150 mbar. 7. Maintain the water in the patient's colon for a few moments. After the set time, set the control valve (11) to

quick Discharge.

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TECHNICAL CHARACTERISTICS - VDE-FI protective switch, to provide maximum safety for patient and therapist. - Rated working voltage: 230V or 110V or 100V - Frequency: 50 or 60 Hz - Protection class: I - Power: 15 W - Connected to the mains. - Lead with plug. - 5-micron polypropilene filters. - U.V. Lamp to sterilize the water: 30 mJ/cm2 for 150 L/h. - Polyamide tubes and connectors approved by the NSF (National Sanitation Foundation, USA). - Manual temperature control. - Glass-free viewing tube light. - Fully built-in cleaning system. - Inlet for trace elements. - Inlet for oxygen. - Inlet for ozone.

SESSION PARAMETERS Flow rate adjustable from 0 to 100 l/h (60-80 l per session). Pressure 0 - 150 mbar. Temperature 22 - 40°C.

SAFETY AND PERFORMANCE 1. If the maximum temperature of 40°C is exceeded or the minimum of 22ºC is not reached the machine

disconnects automatically. These maximum settings can be changed if the therapist requires. 2. The electrical system is fully isolated to avoid any discharge during its use

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TROUBLE SHOOTING GUIDE IRRIGATION In case the irrigation process does not work, this may be caused by the following situations: 1. Alarm temperature reached:

Regulate the maximum or minimum temperature of the thermostatic gauge. 2. Pressure exceeded:

a) Check that the rectal nozzle is correctly placed in the sphincter of the patient. b) Check that the circuit from the rectal nozzle to the viewing tube is not blocked. c) In case the problem is not caused by the former mentioned causes please contact Transcom Colon

Hydrotherapy for service. 3. Other problems:

If you experience irrigation problems other than those described above, please contact TRANSCOM, as the problem may be caused by an internal failure.

TEMPERATURE 1. If the temperature does not reach 100ºF (38ºC), check that water heater works properly. 2. Check the mixing valve. See mixing valve item. 3. If the thermostat shows an alarm sign, carry out as the workbook of the thermostat states. 4. If it does, please contact Transcendencias Comerciales S.L. for service. PRESSURE 1. If during the session the pressure gauge does not show any rates, it must be replaced. 2. In case the Irrigation does not switch off when the pressure exceeds 2.17 psi (150 mbar), the pressure gauge

must be readjusted. 3. If the problem still remains once the gauge is readjusted, it must be replaced. VIEWING TUBE During the filling mode the viewing tube must be filled completely. If not or if it needs more than 2 minutes to be filled, the pressure regulator placed on the left side of the tube must be ajusted. IF THERE IS A WATER LEAK 1. Shut off the water supply on the inlet side of the unit. 2. Disconnect power cord. 3. Check the status of the filter housings, inspect both the housing and the housing caps. Check to make sure

the “O” rings are in the place within the bottom housing filter.

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4. Check the status of the unions between pipes and connectors. Make sure all quick disconnects are put together; the best way is to disconnect and reconnect making sure they click into place.

DISINFECTION 1. If there is not disinfectant in the view tube when the valve is open.

a) Check if the disinfectant deposit contains disinfectant. b) Check that every tubes are properly connected. Make sure that these tubes are without any fissures or

cracks. If you notice any one the damage tube must be replaced. c) Once we have checked all the tubes and the two ways valve and they are all right, the anti-reflux valve

has a problem and it must be changed. 2. If the viewing tube can not be filled with cleaning water:

a) Check that every tubes are properly connected. Make sure that these tubes are without any fissures or cracks. If you notice any one the damage tube must be replaced.

b) See viewing tube item, to solve the problem.

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WARNING LABELS The following labels have been placed in the Operating Instructions Manual, which are warning labels intended to notify the user of certain restrictions and potential hazards. “The therapist must remain with the patient at all times” “Tampering with electrical components may cause electrical shock” “Tampering with settings or adjustments by unauthorized personnel may cause injury to the client and will void any warranty or liability” “Consult manual prior to operation of this equipment” “Do not plug any other electrical appliances in the same outlet or plug in multiple outlet strips. For information on your wiring or local building codes it’s better to consult with a local electrical contractor and plumber prior to the operation of this equipment”. “Do not tape or tie up any of the water lines, drainage line or electrical line to any other part of the colonic machine or any combination of the above mentioned items, this will result in damage to the equipment and the performance of the equipment”. “Never leave the colonic machine unattended if the water supply line source is on, always turn off the water supply source when unattended. We are not responsible for flooding from this equipment. Equipment should be attended at all times while water supply source is on to avoid flooding in case of leakage. Water supply could be shut off in the event of leakage if the equipment is attended”.

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SCHEDULED MAINTENANCE ITEMS

Our Colon Hydrotherapy colonic machine does not have any regular scheduled maintenance. But proper care and preventative maintenance and the section on cleaning methods and using the equipment as stated in the operation manual will lead to many years of life to the equipment. Parts over the years will wear out from normal wear and tear on the equipment. When you see the first signs of a problem or that the equipment is not operating as usual, you should stop using the equipment and report the problem to Transcendencias Comerciales S.L. for the device to be checked and inspected prior to a new use. All water lines and fittings should be checked for signs of wear and leaks; if so, replace as needed. NOTE: Check all water line clamps for tightness and leaks, tighten as necessary and this should be done every two weeks or less on all clamps and fitting both colonic machine and the water filtration system. If water filtration system is installed, the water filters will have a regularly scheduled maintenance and replacement schedule. This is discussed in the section on water filtration systems. As stated this will be very depending on your area water and the amount of treatments and time between filter cartridge replacement.

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COLON HIDROTHERAPY DEVICE

“HC – 1 NEW” INSTALLATION

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PACKING LIST AND DEVICE LABEL

The list of items showed below is 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 water supply and drainage lines. Other accesories can be added as discussed in other sections of this manual. 1) SPIGOT CONNECTOR PVC TUBE 6mm 3 UNITS 2) POLYPROPYLENE FILTER WITH HOUSING 2 UNITS 3) CLEANING FLEXIBLE HOSE 1 UNIT 4) FUSE 2-A 2 UNITS 5) FUSE 1-A 2 UNITS 6) POLYAMIDE PIPE 10mm 1.5 M 7) NET WIRE 1 UNIT 8) RACOR CONNECTER TUBE 10mm-1/2” 2 UNITS 9) RACOR BEND CONNECTOR TUBE 10mm 2 UNITS 10) WHEEL 6 mm TO FIX BOTTLE 1 UNIT 11) 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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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 that there is a problem, please send us the information requested below: If merchandise was damaged in shipping, do as follows: 1. If possible, note visible damage to cartons and the exent of damage before signing shipping documents. 2. Keep all original packaging 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 authorization. We will contact you inmediately upon reception of this notice. Product(s) ( )arrived damaged: ( )wrong order ( ) 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 of Invoice:_____________ Phone No. ( ) ___________________ Customer Name:___________________________________ Adress: ___________________________________ City:___________________State:____________________Zip:___________________ Shipping Adress (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.:34 943 224 275 E-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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WARRANTY INFORMATION

We the undersigned, guarantee all equipment to be free from defects in material and workmanship for a period of two years from the date of 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 as the seller/manufacturer remains in business. Our option to repair and/or replacement will be (F.O.B.) Free 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 two years unlimited warranty and the defect is manufacturer´s 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. 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 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 made by a licensed plumber and electrical contractor. Also they must meet the specifications set by Transcendencias Comerciales S.L.. This is to ensure 100% efficiency for the colonic equipment.

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Type of equipment and Voltage Customer’s Name Serial Nº Purchase date

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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 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) 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

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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

COLON EQUIPMENTS SAN SEBASTIAN - SPAIN

HC – 1 NEW

WEIGHT 45 KG. / 99 LBS. DIMENSIONS 700 x 800 x 1200 mm / 27,55 x 31,49 x 47,24 inches

NON-STERILE QUANTITY 1

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SHIPPING

All shipping will be arranged between the client and the manufacturer, which will best suit the needs of our customers. 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 checked 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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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 furnished, 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-1 NEW ____________________________________ SERIAL NUMBER: ___________________________________ VOLTAGE: � 110 V / 60 Hz � 220 V / 50 Hz SELLER: ___________________________________________ Signed DATED:____________________________________________ BUYER:____________________________________________ Signed DATED: ___________________________________________

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ESSENTIAL TECHNICAL REQUIREMENTS FOR THE INSTALLATION AND CORRECT OPERATION OF THE HC-1 NEW "HYDRO-COLON" MACHINE W "HYDRO-COLON" MACHINE

Pre-installation consists of: Pre-installation consists of:

- 1/2" cold water inlet - 1/2" cold water inlet - 1/2" hot water inlet - 1/2" hot water inlet - 32 mm waste water outlet pipe - 32 mm waste water outlet pipe - Siphon for connecting the drain outlet to the waste water outlet - Siphon for connecting the drain outlet to the waste water outlet - 2 constant pressure regulators rated at 2 bar (minimum) - 2 constant pressure regulators rated at 2 bar (minimum) - 1 electric heater for 60 l or 16 gallons (minimum) - 1 electric heater for 60 l or 16 gallons (minimum)

The height and distance from the stretcher indicated in the pre-installation drawing supplied with the unit must be respected. The height and distance from the stretcher indicated in the pre-installation drawing supplied with the unit must be respected. Mains voltage must be 220 V 50 Hz, and the unit must be installed at least 1 m from the power point. Mains voltage must be 220 V 50 Hz, and the unit must be installed at least 1 m from the power point. The constant hot and cold water pressure should be the same, and should not be less than 2 bar. A constant pressure The constant hot and cold water pressure should be the same, and should not be less than 2 bar. A constant pressure regulator may be fitted on each inlet pipe if required. The siphon should be as low as possible to ensure that the machine will discharge for cleaning. The hot water temperature should be between 60 and 80°C or 156º and 208ºF. Temperature in the Hydro-Colon unit is regulated by hot water supplied through a pressure accumulator so that temperature can be controlled more accurately. The unit requires an inlet temperature of 60°C or 156ºF and a pressure of 2 bar. The working flow-rate is between 60 and 100 gallons per hour or 16 litres per hour. Do not install low pressure storage heaters, low voltage instantaneous heaters, butane gas or town gas heaters. If your mains electricity is not supplied at the voltage indicated, please inform TRANSCENDENCIAS COMERCIALES S.L. so that the unit can be adjusted accordingly. IMPORTANT NOTE Failure to meet any of these requirements will prevent the machine from being set up properly.

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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U.V. LAMP INFORMATIONAL INDEX

The U.V. lamp placed in your colon hydrotherapy device is covered under the NSF 55 branch related to the use of U.V. together with water. While the recommended quantity of U.V. light to be applied to poluted water is 38 µw·sg/cm2 and 18.000 µw·sg/cm2 for drinking water, the U.V. lamp used in Transcendencias Comerciales, S.L. colon hydrotherapy devices emits de 60.000 µw·sg/cm2 or 60 mJ/cm2.

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COLON HIDROTHERAPY DEVICE

“HC – 1 NEW”

OFFICIAL APPROVALS

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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-1 NEW PROCESSS MANUAL PAGE - Indications for Colon Hydrotherapy 3 - Contraindications for Colon Hydrotherapy 3 - Intended Use Statement 3 - Patient Population 3 - Design 4 - Characteristics 5 - Main Switch 5 - Pressure Gauge 5 - Flow Rate Regulator 5 - General Control 5 - Digital Thermostat 6 - Control Valve 6 - Disinfectant Valve 6 - Cleaning Valve 6 - Disinfection deposit 6 - Instrucitons for the setting of the thermostat 7 - Control Valve: Filling – Quick discharge 8 - Residues Inlet 8 - Irrigation Outlet 8 - Cleaning Water Outlet 8 - Viewing Tube 9 - Filters 9 - U.V. Lamp 9 - Residues Outlet 9 - Plug and Mains Cable 9 - Fuses 9 - Socket 9 - Identification Plate 9 - Metal Support and Glass Bottle 10 - Introduction Trace Elements etc. 10 - Detailed Description of a Session 11 - Instructions for disinfection 14 - Maintenance of the Internal Machine Cleaning Unit 15 - Changing Filter Cartridge 15 - Changing of the U.V. Lamp 15 - Aplication of Trace Elements etc. 16 - Technical Characteristics 17 - Session parameters 17

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- Safety and Performance 17 - Trouble Shooting guide 18 - Warning Labels 20 - Scheduled Maintenance Items 21 HC-1 NEW INSTALLATION 22 - Packing list and device label 23 - Letter 24 - Warranty information 25 - Assistance 26 - Packing 27 - Shipping 28 - Installation 29 - Essential technical requirements for installation 30 -.U.V. lamp informational index 34 HC-1 NEW OFFICIAL APPROVALS 45 HYDRO-KIT 52