waterpowered My Perfect Colon Pro User manual

EN User guide
www.waterpowered.eu
[email protected]
800577477

E
E
200
400
600
800
1000
1200
1400
1500
36°C
38°C
H O
Approx.ml.
A
BB1
D
(x5)
F
I (x12)
J
H
C
G
C2
C1
C3
C4
C
2A
1 2 3
E
E
2
General Diagram

E
E
200
400
600
800
1000
1200
1400
1500
36°C
38°C
H O
Approx.ml.
A
BB1
D
(x5)
F
I (x12)
J
H
C
G
C2
C1
C3
C4
C
2A
1 2 3
E
E
WARNING: Read the instrucon manual carefully before use and keep it for future reference.
Use My Perfect Colon PRO according to the indicaons of your doctor and/or professional health worker.
The indicaons received should prevail over these instrucons.
WHAT IS MY PERFECT COLON PRO
My Perfect Colon PRO is an EC medical device for transanal irrigaon.
PRODUCT STRUCTURE AND CONTENT:
A. 2-litre bag with sucon cups and liquid crystal thermometer
B. Sucon tube (1.5 metres) with tube clamp (B1) and ngs
C. Grip with on/o buon and light indicator (C1), Charging socket (C2), Water Inlet Fing (C3), Water
Outlet Fing (C4)
D. 5 Micron Membrane Filter (x5)
E. Water supply reducer (x1)
F. Outlet tube (1 metre) with ngs
G. Support with sucon cups
H. Modeling tube with ngs
I. Rectal Cannula (x12)
J. USB cable
• Case for My Perfect Colon PRO
• Mullanguage Manual
GENERAL WARNINGS
When using electrical products, especially in the presence of children, it is necessary to follow basic safety
precauons.
• To reduce the risk of electric shock when the device is charging, do not touch the plug with wet hands;
• Do not use while in the bath or when wet;
• Do not place it near or drop it in water or other liquids;
• Do not place or store the device where there is a risk that it may fall into the bath or sink;
• Check if the cable is damaged before using it;
• Do not use the device if it has a damaged cable or socket, if it does not work correctly, if it has fallen, is
damaged or been dropped in water. In this case, contact Water Powered srl;
• Keep the cable away from heat sources;
• Do not connect the device to a voltage system other than the specied one or one that does not have a
grounding line and lifesaver;
• Do not use the device during the recharging phase;
• The device does not produce electromagnec interference.
WARNINGS AND PRECAUTIONS FOR USE
• Before using My Perfect Colon PRO, consult your doctor or a health professional specialized in transanal
irrigaon to check suitability to your personal situaon;
• Transanal irrigaon with My Perfect Colon Pro should always be carried out with cauon;
• Carry out the rst transanal irrigaon under the supervision of a health worker;
• Consult your doctor for any kind of doubt about the use of the device;
• If you feel any parcular discomfort during or aer using My Perfect Colon Pro, stop using it and consult
your doctor. Immediately request medical assistance if during or aer the irrigaon procedure you feel
intense or connuous abdominal pain, back pain or rectal bleeding during or aer the irrigaon. Intesnal
perforaon is an extremely rare but very serious complicaon of transanal irrigaon. Symptoms of
intesnal perforaon include intense and prolonged abdominal or back pain or rectal bleeding;
• Keep the device out of the reach of children. Supervise children if they are near the device to avoid the
3
EN INSTRUCTION MANUAL

risk of strangulaon with tubes, suocaon with the bag or with small components that may detach
from the product;
• For hygiene reasons, every My Perfect Colon PRO device must be used only by one user;
• The rectal cannula is disposable, and reuse is potenally harmful to the user;
• Use water between 36°C and 38°C;
• Use clean running water or, if you have any doubts about the quality, use My Perfect Colon water lters.
Alternavely, use boled water
• Turn o the device when the water in the bag nishes;
• Empty your bladder before irrigaon;
• Make sure you are comfortably seated on the toilet to facilitate pelvic oor relaxaon;
• In some cases, it is possible that the eect of the irrigaon could be parcularly eecve and that the
smulus to evacuate could recur several mes in the 2-3 hours aer irrigaon;
• The body has to get used to the treatment with transanal irrigaon. In the absence of parcular pathologies
and if you follow a healthy lifestyle and a correct diet, the benecial eects will be seen aer a few sessions;
• The tubes must be installed as per instrucons so as not to cause damage to the device.
CONTRAINDICATIONS
• Transanal irrigaon with My Perfect Colon PRO must not be carried out in the following cases;
◦ Acute diverculis;
◦ Acute inammatory bowel disease;
◦ Colorectal carcinoma;
◦ Known rectal or colorectal stenosis;
◦ Within 4 months of colorectal or rectal surgery;
◦ Within 5 weeks of endoscopic polypectomy;
◦ Ischemic colis;
◦ Children under 3 years of age. For children it is always necessary to consult their doctor before use;
◦ Women during pregnancy, planned pregnancy or breaseeding.
• Special care should be taken if you suer or have suered from the following diseases in the past:
◦ Faecal compress: in case of strong conspaon, it is necessary to carry out an inial cleaning of the
intesne before starng irrigaon treatment;
◦ Painful anorectal condions, such as rhagades, stulas, third or fourth-degree haemorrhoids;
◦ Paents with a risk of autonomous dysreexia should carry out irrigaon under supervision;
◦ Severe diverculosis or divercular abscess;
◦ Irradiaon therapy in the abdominal or pelvic region;
◦ Previous rectal or colorectal surgery;
◦ Previous major surgeries in the pelvic area;
◦ Severe Autonomic Dysreexion;
◦ Variaon in the consistency of faeces, such as diarrhoea (the cause of diarrhoea should be idened)
◦ Increased risk of bleeding or ongoing ancoagulant therapy (excluding aspirin or clopidogrel);
◦ Long-term corcosteroid therapy;
◦ Rectal medicaon.
• The device is not suitable for use by children or persons with reduced physical, sensory or mental
abilies unless they receive adequate assistance;
• Do not use the device for applicaons other than those indicated;
• Do not use accessories not recommended by the manufacturer;
• Do not drop or insert any foreign object into the openings of the device;
INSTRUCTIONS
Preparation of the device and Use sitting on W.C.
1. Connect the 1.5-metre sucon tube (B) to the bag (A) using the threaded connecon, turning clockwise
unl it stops;
4

2. Ensure the tube clamp (B1) on tube B is ght and ll the bag with warm water (between 36 ° and 38 ° -
check the temperature highlighted in green/brown on the thermometer axed to the bag. If no colored
dot appears, the water temperature is higher or lower than the thermometer range. The value is indicave
- tolerance +/- 10%);
3. Close the bag by screwing the cap well, x it to the wall (smooth and clean surface) or a mirror thanks to
the sucon cups at the height of about 1m or place it on the oor or a stable surface; Posion the bag
near the toilet bowl so that the tube clamp (B1) can be reached by hand when seated;
4. Connect the other end of the sucon tube (B) to the water inlet ng (C3) located on the handle;
5. Connect the 1-metre tube (F) to the water outlet tube ng (C4) located on the handle C;
6. Connect the other end of the tube F to the support (G) and apply the sucon cups to the front of the
toilet seat or the toilet itself;
7. Connect the tube ng of the sucon cup holder (G) to the modeling tube (H);
8. Connect the cannula (I) to the modeling tube (H);
9. Unlock the tube clamp (B1) to allow the passage of water and, placing the cannula (I) inside the toilet, press
the power buon C1; run the water through the tubes for a few seconds to check the correct connecon
and operaon (it is possible that the air present in the empty tubes is inially sucked and expelled);
10. Switch o the device by pressing the C1 buon, ghten the tube clamp (B1) and sit on the toilet,
placing the tubes between the legs;
11. Gently insert the cannula into the rectum without forcing it. If you feel resistance to inseron, remove
the cannula and ensure that the rectum is empty (manual evacuaon may be necessary to facilitate
emptying). Try using lubricang ointments to facilitate inseron. If resistance persists, do not force it,
stop irrigaon and ask for the support of a health professional;
12. Unlock the tube clamp (B1) and start irrigaon by pressing the power buon C1 (the indicator light will
turn on - read the paragraph “Instrucons for irrigaon”);
13. To stop water supply, press the C1 buon. To be aware of the amount of water introduced during
washing, every 30” the device turns o interrupng the supply; this security system prevents more
water than desired to being inadvertently introduced. Press the power buon again to connue the
irrigaon for another 30”. To check the amount of water that is dispensed according to the dierent
conguraons, see table 1 in the paragraph “Instrucons for irrigaon”;
14. Aer irrigaon, turn o the device by pressing the C1 buon and close the tube clamp (B1).
Use for bedridden people:
In case of use by bedridden people, therefore not on the toilet, the mounng of the tube with support and
sucon cups (G) and the modeling tube (H) are not necessary. Connect the cannula directly to the outlet
tube (F).
Use in supine posion
For an even more eecve cleanse, it is recommended to carry out washing in the supine posion. For this
purpose, the My Perfect Colon board and the Comfort Wash Mat are available. Accessories available on
www.myperfectcolon.com or www.waterpowered.eu. In case of use in the supine posion, the tube with
support and sucon cups (G) and the modeling tube (H) are not necessary. Connect the cannula directly
to the outlet tube (F).
Indications for irrigation
• The amount of water required for transanal irrigaon is subjecve. For adults, it can vary from 300 to
1,000 ml up to a maximum of 1,500 ml (according to the instrucons of your doctor). For children, 10-20
ml for each kg of weight. The bag can contain a max. of 2 liters of water;
• Use water between 36°C and 38°C. If the water is too hot, it can damage the delicate lining of the
intesne. If too cold, stomach cramps can occur. If you feel a temperature that is too hot or cold during
use, turn o the device and replace the water in the bag with water at the correct temperature. Help
yourself in regulang the water temperature with the thermometer placed on the bag;
5

• Quality of the Water and Filters My Perfect Colon:
◦ Use clean running water or, if you have any doubts about the quality, use My Perfect Colon water
lters. Alternavely, use boled water;
◦ Use of the lter D is oponal. If you want to use it, t between the C4 tube ng and the F tube;
◦ By mounng the lter, the quanty of water supplied is slightly reduced and in proporon to the
quality of the water (the more impuries are present in suspension in the water, the more the ow
tends to be reduced - see table 1 as a reference for the quanty of water supplied for each session
under normal condions);
◦ Warning: Never use the lter for mulple irrigaons. Replace the lter aer each irrigaon to
ensure the purity of the water, an adequate ow, and avoid the proliferaon of bacteria between one
irrigaon and the next. Replacement lters are available on the website www.myperfectcolon.com e
www.waterpowered.eu.
RECHARGE MANAGEMENT
• The supplied cable has a USB socket. To recharge the device, connect the cable to the charging socket
(C2) of the device and the other end to a common charger with a USB port (not supplied);
6
• Make sure that the ow in the tubes is not blocked or slowed down by obstrucons or kinks;
• During irrigaon, posion the bag at the height of about 1m, thanks to the sucon cups supplied. Where
the bag is placed on the ground, posion it slightly on a slope so that the water is directed towards the
outlet to avoid sucking in air;
• Emptying: aer compleng the inseron of water, the intesne will begin to empty. Especially during the
rst few uses, it may be necessary to wait a few minutes, even 15-30 minutes, before the colon begins
to empty. Make sure to expel all the water. To facilitate emptying, try bending forward, coughing, and/
or doing an abdominal massage;
• Evacuaon mes are subjecve and may vary from session to session.
• Amount of water:
◦ For every 30” session, about 475ml of water is dispensed (considering the posion of the bag at about
1m of height);
◦ If you prefer less water ow, connect the reducer between the connecon of the outlet tube (C4) and
the tube F (g. 2): in this way there will be a reducon of about 30% of the ow rate compared to the
normal one when the reducer is not mounted (g. 1). If you prefer an even lower ow (approx. -70%),
connect the reducer (E) between the sucon tube (B) and the water inlet ng (C3 - g. 3). See the
table below for the specicaon on the dierent ow rates;
◦ Depending on the height at which the bag is posioned, the amount of water dispensed per minute
may vary (the lower the bag is posioned, the lower the amount of water dispensed).
Table 1 - Amount of Water per Session according to the dierent Conguraons - considering the
device fully charged and the bag posioned at about 1m of height - (toler. +/-20%)
Time / Session
of 30”
Without
reducer and
lter E (g.1)
With Reducer
(E) on Outlet
tube (g.2)
With Reducer
(E) on Inlet
tube (g.3)
With Filter (D)
on the outlet
tube
With Filter (D)
and Reducer
(E) on the
outlet tube
30 ” / 1
Session
475ml approx. 325ml approx. 150ml approx. 375ml 275ml
60 ” / 2
Sessions
950ml approx. 650ml approx. 300ml approx. 750ml 550ml
120 ” / 3
Sessions
1425ml
approx.
975ml approx. 450ml approx. 1125ml 825ml

• It is advisable to carry out the rst recharge of at least 1 hour;
• While charging is in progress, the indicator light (C1) will be red. When fully charged, the indicator light
will turn o;
• Overload protecon: charging will be automacally suspended when the baery is charged;
• With the device in operaon, the indicator light will light up.
CLEANING AND MAINTENANCE
• Rectal Cannula: The cannula is for single use only. Do not reuse, wash, disinfect or sterilize. Reuse
can lead to infections. After use, throw away the rectal cannula and dispose of it with normal
household waste (Replacement cannulas are available on the website www.myperfectcolon.com
and www.waterpowered.eu);
• Bag: after each use, empty it and let it dry, keeping the cap unscrewed and store it dry. The bag
should preferably be changed after about 15 uses (Replacement bags are available on the website
www.myperfectcolon.com and www.waterpowered.eu);
• Aer use, disconnect the tubes and drain the residual water (if necessary, blowing from one end);
• Aer drying all components with a delicate cloth, store them in a dry place at room temperature and
away from direct sunlight. When storing the product, check that the tubes are not twisted and that they
are not close to pointed / sharp objects;
• Store the product with the tubes detached from the bag and handle;
• To periodically clean the internal surface of the tubes and the bag, ll the bag with water and mild
natural soap and start the device to let the water ow into the tubes, draining into the sink. Aerwards,
repeat this procedure with at least 4 litres of clean running water to clean from any soap residue;
• At the end of use, detach the tubes and turn on the device for a few seconds shaking it with tubes
hanging down to let the residual water run out;
• Leave the grip handle in a cool dry place, possibly vercally, unl the transparent tube is completely dry.
7
TECHNICAL SPECIFICATIONS
Maximum water pressure: 80 PSI
Maximum water ow per minute: 1,2 L
Baery: Li-Ion 3.7V - 560mAh
In case of need, contact Water Powered srl to receive adequate instrucons for solving the problems
([e-mail] - www.myperfectcolon.com – www.waterpowered.eu).
Problem Possible Cause Possible Soluon
There is a leak between the
tubes Incorrect connecon Unscrew the ngs where the leak occurs and screw it back on
The device does not turn on The pump does not start Make sure the device is charged
Lile / no water comes out of
the cannula
Clogged tubes
Make sure there are no
obstrucons in the tubes or that
they are not kinked
Tightened tube clamp Make sure the tube clamp (B1)
is not ghtened
Bag posioned on the ground
incorrectly
posion the bag slightly inclined
to direct the water towards the
outlet and facilitate dra
No water Rell the bag with more water
RESOLVING EVENTUAL PROBLEMS

8
Recommended Charger: 5V – 1A
Protecon: IP21
Environmental Condions of Use: Temperature from +18 to +35 °C; Humidity 30%-75% does not condense;
Pressure 860÷1060 hPa;
Environmental condions for transport and storage: Temperature -25÷70 °C, Humidity 25÷75%, Pressure
860÷1060 hPa.
SPARE PARTS AND ACCESSORIES
You can purchase the full range of My Perfect Colon products on the website www.myperfectcolon.com
e www.waterpowered.eu.
WARRANTY
The warranty rules are valid only if the device is used according to the condions of intended use.
With the excepon of the maintenance operaons described in the MAINTENANCE sect. and performed
with the procedures indicated, any repair or modicaon made to the product by the user or by
unauthorized companies will result in the forfeiture of the warranty.
The warranty does not extend to damage caused by inexperience or negligence in the use of the product
or by poor or omied maintenance.
The warranty is valid for a period of twelve (12) or twenty-four (24) months, depending on the type of
buyer (legal or private).
The manufacturing company undertakes to replace the malfunconing or incorrectly manufactured parts
at its discreon, only aer careful control and vericaon of faulty manufacture.
The transport and/or shipping costs in the event of incorrect use of the warranty terms are always charged to the buyer.
During the warranty period, the replaced components become the property of the manufacturer.
The warranty does not include damage resulng from excessive stress, such as the use of the product
aer nding a fault, the use of unsuitable operang methods, and failure to observe the instrucons of
use and maintenance.
The manufacturer assumes no responsibility for any dicules that may arise in resale or use abroad due
to the provisions in force in the country where the product was sold.
The defecve product must be delivered to the manufacturer for replacement; otherwise, the replaced
part will be charged to the buyer.
Authorized product assistance is performed directly by Water Powered s.r.l. or by a qualied technician
appointed by the same.
DISPOSAL
The possibility of reusing some parts of the product is subject to the total responsibility of the user.
The symbol indicated in Legislave Decree 49 of 14 March 2014 transposes Direcve 2012/19 /
EU, indicang the need to dispose of the product in dierenated waste, specically in electrical
and electronic waste.
The product must not be disposed of with other domesc waste. Users must arrange for the disposal of
the equipment to be scrapped by taking it to the collecon point indicated for recycling electrical and
electronic equipment.
DECLARATION OF CONFORMITY
Water Powered Srl declares that this device complies with the safety and performance requirements and
the provisions of the MDR 2017/745 Regulaon
The declaraon of conformity can be downloaded from the websitewww.myperfectcolon.com. If it is not
possible to download the documentaon from the site, it is possible to request it directly from Water
Powered Srl.
ACCIDENTS
Any serious incident in relaon to the medical device we have supplied must be reported to the
manufacturer and the competent authority of the Member State in which you are located.

9
ELECTROMAGNETIC COMPATIBILITY
Levels of conformity according to the EN 60601-1-2: 2015 standard
- ESD immunity 15kV in air 8kV on contact (EN 61000-4-2)
- 2kV / 100kHz burst immunity (EN 61000-4-4) power supply / 1kV signals
- Surge immunity (EN 61000-4-5): 1kV common / 2kV dierenal
- Magnec eld (EN 61000-4-8): 30A/m
- Immunity dips: 0% 0,5 cycles; 0% 1 cycle; 70% 25 cycles (50Hz) e 30 cycles (60Hz);
Interrupons: 250 cycles (50Hz); 300 cycles (60Hz)
- Immunity to rf currents in the range 150kHz-80MHz (EN 61000-4-6) 3V modulaon 80% 1kHz
- 6V modulaon 80% 1kHz for the following frequency ranges:
6,765 MHz ÷ 6,795 MHz
13,553 MHz ÷13,567 MHz
26,957 MHz ÷ 27,283 MHz
40,66 MHz ÷ 40,70 MHz
- CISPR emissions 11 class A
- Harmonics EN 61000-3-2 class A
- Flicker pst, dt, dc
Field (V/m) Frequency Modulation
3 80MHz¸2700MHz 1kHz AM 80%
27 380MHz¸390MHz 18Hz PM 50%
28 430MHz¸470MHz 18Hz PM 50%
9704MHz¸787MHz 217Hz PM 50%
28 800MHz¸960MHz 18Hz PM 50%
28 1700MHz¸1990MHz 217Hz PM 50%
28 2400MHz¸2570MHz 217Hz PM 50%
95100MHz¸5800MHz 217Hz PM 50%
Field Form Frequency
90V/m AM 80% 1kHz 800MHz-
960MHz
50 V/m AM 80% 1kHz 1.4GHz-2GHz
35V/m AM 80% 1kHz 2GHz-2.48GHz
28 2400MHz¸2570MHz 217Hz PM 50%
95100MHz¸5800MHz 217Hz PM 50%
Immunity to magnec eld (EN 61000-4-3):
Test level
Levels of conformity according to the EN 60118-13: 2011
Rated maximum
output power of
transmier
(W)
Distance (m) of separaon according to the frequency of the transmier
from 150kHz to 80MHz
d = 1,2 √P
from 80MHz to 800MHz
d = 1,2 √P
from 800MHz to 2.5GHz
d = 2,3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

SYMBOLS
Symbols Symbols
Meaning Meaning
Manufacturer
EC Brand The device respects
the regulaon MDR 2017/745.
Catalogue number
Lot number
Keep away from sunlight
Keep away from damp
The company reserves the right to make paral or total changes to the product, which may dier from
the manual’s descripon.
The manufacturer, distributors and retailers decline all responsibility for any damage that may, directly
or indirectly, arise to people or property due to failure to comply with all the requirements indicated in
this user manual.
My Perfect Colon devices are not and do not replace the equipment used in colon hydrotherapy centres.
Visit www.myperfectcolon.com or contact [e-mail] for further informaon.
For any claricaon or further informaon, visit the site www.myperfectcolon.com or contact customer
care by email [e-mail].
DISCLAIMER:
Although compliant with the EN 60601-1-2 standard, the My Perfect Colon PRO medical device can
interfere with other devices in the vicinity. The device should not be used adjacent to or stacked with
other equipment. Install the device away from other equipment that radiates high frequencies (short
waves, microwaves, electrosurgical units, cell phones).
The use of this appliance near or placed on other appliances should be avoided, as this can lead to
incorrect operaon. In these cases, the device and other equipment must be kept under observaon to
verify their regular operaon.
Portable RF communicaons equipment (including peripherals such as antenna cables and external antennas)
should be used no less than 30 cm (12 inches) from any part of the My Perfect Colon PRO, including specied
cables by Water Powered Srl. Otherwise, performance degradaon of this equipment may occur.”
The device is designed to operate in an electromagnec environment in which radiated RF disturbances
are under control. The customer or the operator can help prevent electromagnec interference by
ensuring a minimum distance between mobile and portable RF communicaon devices (transmiers)
and the medical device, as recommended below, in relaon to the maximum output power of the radio
communicaon devices.
For transmiers with a maximum rated output power not listed above, the recommended separaon
distance (d) in metres (m) can be calculated using the equaon applicable to the transmier frequency,
where P is the maximum rated output power of the transmier in Wa (W) according to the transmier
manufacturer.
Note:
(1) At 80 MHz and 800 MHz, the higher frequency range applies.
(2) These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon
and reecon from structures, objects and people.
Warning
Read the instrucons before use.
Read the instrucon manual
For disposal, the product must be delivered
to an appropriate collecon point to recycle
electrical and electronic equipment (WEEE).
Medical device
Manufacturing date