MU Turbimed ENG Version 05

TURBIMED

2009 2012 2039

User Manual English

Revision : 05

Carci Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. Made in Brazil

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MU TURBIMED_ENG_REV 05 08/2007 1

Co n t en ts

02 .............. General information

03 .............. Installation

03 .............. Connection to the power system

04 .............. Hydraulic system

05 .............. Description of the turbine

06 .............. Installation of the turbine in the tank

06 .............. Operation

07 .............. Safety rules

08 .............. Indications

08 .............. Contraindications

09 .............. Tank Models

12 .............. Preventive maintenance and conservation

13 Cleaning

14 .............. Corrective maintenance

15. ............ Technical characteristics

17 Symbols

19 Electromagnetic Compatibility Information

23 .............. Final comments

24 .............. Bibliographic references

.................. Annexes A.3

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Gen e ra l I n f o r ma t i o n We, from CARCI, would like to congratulate you for the acquisition of this equipment, in which Quality, Technology and Safety are always paramount. Hydrotherapy is one of the oldest therapeutic methods for the treatment of physical dysfunctions. It has been used for the treatment of hardened joints, painful scars, adhesions, and arthritis and also as a warm-up prior to physical exercises Whirlpool is an equipment comprising a tank containing water at a certain specific temperature, which is stirred by means of a turbine that regulates the flow and the aeration of the water by the passing thereof through a chamber that forces it outwards through a nipple or a direction setting device. This phenomenon called whirling is an effective method to transfer energy to the body, by means of a convection process caused by the application of heat or cold to corporal areas. The presence of the water creates a good means of support for active exercises. During the execution of slow movements, the buoyancy of the members of the body helps the movements. When the exercises are performed with greater speed, the water creates a resistance to the movements. The agitation and aeration of the water caused by the Turbine act as a process of massage, with sedative, analgesic and blood circulation increase effects. The Whirlpools Turbimed are manufactured in three models: 2039 For treating the upper limbs 2009 For treating both upper and lower limbs 2012 For treating the entire body Models 2009, 2012 e 2039 are sets composed by tanks models 2001, 2002, and 2003, and by the turbine model 2021.

The tanks and the turbine may be supplied separately

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I n s ta l l a t i o n For the perfect functioning of your equipment, the electric installation must comply with the following standards: Brazil: NBR 5410/1990 Low tension electric installations; NBR 13534/1995 Electric installations in healthcare establishments -

Safety Requirements. Other countries: IEC 60364-7-710/2002 Electric installations medical locations; Or other standard applied in country of utilization. Co n n e ct i o n t o th e p ow er s yst em The connection to the power system 127 V~, 220 V~ or 230 V~ is made according to follow diagram, being indispensable the installation of the electric protection system that is supplied with the equipment The power supply voltage should be within the range specified in the Technical Characteristics; otherwise there might be degradation in the equipment working and safety risk. This CARCI protection system is composed by a thermal switch that turns off the motor if the internal temperature reaches 130C, turning it back on when the internal temperature of the motor goes down to at least 70C. The protection box is composed by a differential circuit breaker, the purpose of which is to protect the patient from any risk of electric shock, and a set of safety fuses to protect the motor in case of any failure. Non-compliance with this item may entail safety risks to the patient and/or the operator, for which CARCI is exempt of any liability.

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Consult annexes: Drilling template of the Electric Protection Box H yd ra u l ic S yst e m The whirlpool tank may be fed through the direct supplying of water from the local existing hydraulic system. The drainage of the water is made through a valve located at the bottom of the tank. A connection must be made from the drainage valve (3/4) to the specific sewer system for hospital sewage.

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De s cr i p t i o n o f t h e Tu rb i n e

Mo de l 20 21

1 . On/Off switch 2 . Directional nipple 3 . Transportation support 4 . Three pole power cable for

connection with the power system 5. Support of the turbine 6 . Direct jet 7 . Bypass crank of the direct jet or

directional nipple 8. Directional nipple hose 9. Turbine attachment support 10. Turbine attachment rod 11. Drainage water valve crank

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I n s t a l l a t i on of t h e tu rb in e in t h e t an k

a. Loosen the turbine attachment support (9) b. Hold the turbine by the support (3) c. Place the support of the turbine (5) on the rod (11) d. Adjust the height of the turbine e. Tighten the attachment support (9) to fasten the turbine in the desired

position

Op er at i o n

Instruct the patient not to touch the on/off switch of the turbine, or any electric connection during the treatment or while the body is still wet.

Feed the tank with enough water to cover the area to be treated. The water level should be at least 20cm above the base of the turbine.

In case there are any injuries in the area to be treated, use a disinfectant containing sodium hypochlorite.

Adjust the temperature of the water according to the type of effect desired.

The heating of the water must be performed externally, or by means of a normalized electric heater.

Note: For safety reasons never turn on the turbine if an electric heater is inside the tank.

If the treatment is to be made on the members, place the patient in a comfortable position using the whirlpool chair model 2050.

The arm or the leg of the patient should be properly resting upon the rim of the tank, using a folded towel as support for the member, so as to prevent any circulation impairment.

Open the cover of the protection system box and activate the circuit breaker by just pushing the blue lever up. This procedure is to be done only once, being unnecessary to turn on and off the circuit breaker at each therapy section. Always use the on/off switch of the whirlpool to do this.

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Turn on the turbine through the on/off switch located on its upper portion, adjust the height and direction of the water jet, and start the treatment.

Patients being treated for the entire body must be continuously monitored.

The equipment is to be operated at a room temperature varying from 15 to 35C (59 to 95F).

Safety Rules

Proper compliance with the specifications of the products to be added to the water and with the medical indications to the patients.

In case o using warm water, make a previous control of the temperature by means of a thermometer.

This equipment should be operated by qualified personnel only, pursuant to the legislation in the country of use.

Do not put any cloth or obstruct the openings of the turbine ventilation. This may cause the equipment overheating.

Do not turn on the turbine out of the water

The equipment should not be operated outside the temperature range specified in the technical characteristics, as this would result in overheating and risk to safety.

The turbine is not protected against hazardous water penetration (IPX0). Care should be taken in order to avoid water spilling over the turbine.

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I n d i c at i o n s

Reduction of the rigidity of the joints

Stimulation of the cicatrisation of wounds

Sub-acute or chronic inflammatory conditions

Peripheral vascularization pathologies (use water at room temperature)

Peripheral nerves diseases (avoid extremes of hot and cold water)

Relief of pain and muscular spasm

Removal of pus and necrotic tissue Co n t r a i n d i ca t i o n s Acute conditions in which the turbulence or whirling of the water may

cause irritation of the area being treated. Patients requiring postural support during the treatment

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T an k M o d el s Model 2003 Model 2003 is designed for hydrotherapic full body immersion treatment Capacity Approximately 300 liters Weight empty 66 kg Weight w/ water 370 kg. Approximately Dimensions 1.50 x 0.60 x 0.50 (LxWxH) mt.

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Model 2002 Model 2002 is designed for hydrotherapic immersion treatment of the lower and upper limbs Capacity Approximately 270 liters Weight empty 32 kg Weight w/ water Approximately 300 kg. Dimensions 0.90 x 0.50 x 0.70 (LxWxH) mt.

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Model 2001 Model 2003 is designed for hydrotherapic immersion treatment of the upper limbs Capacity Approximately 90 liters Weight empty 20 kg Weight w/ water Approximately 110 kg Dimensions 0.70 x 0.40 x 0.50 (LxWxH) mt.

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P r e v en t i ve m a i n te n an ce Daily control of the power supply and feeding cable of the turbine,

making sure there are no defects. Daily control of the connection of the power cable with the power

system, by checking the contact terminals. Daily checking of the pressure of the turbine jet Daily checking of the state of conservation of the hose of the

directional nipple and the connection thereof. In case of damage, provide its substitution.

Daily checking of the functioning and leak tightness of the tank water

drainage valve. Quarterly checking of the functioning of the protection system, by

pressing the test key, which should turn off the differential circuit breaker. To reactivate the system, activate the circuit breaker, simply pushing the blue lever up

We recommend the equipment to be revised by CARCI or authorized

distributor once a year. The estimated lifetime of this equipment is 5 years. Following this

period, the equipment should be submitted to a thorough inspection by CARCI or authorized distributor so that it may continue to be used in a safe, efficient way.

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Cleaning Disconnect the turbine from the Carci protection system. Supply the tank with enough water for the safe operation of the turbine. Add a commercial disinfectant and a bactericide to the water, using the

concentration recommended in the label. Turn on the turbine for at least one minute to clean the internal

components thereof. After each application, the water should be changed and the whirlpool

should be washed with water and neutral soap. This procedure is considered as adequate for controlling the cross contamination in the tank.

Use a Scotchbrite type sponge weekly to remove occasional crusts. Do not use chlorine for asepsis or cleaning Do not use steel wool Clean the outer surface with stainless steel cleaning products.

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Co r r e ct i ve m ai n t en an c e Problems Solutions Equipment does not turn on

Check if the power cable of the protection system is connected to the power system

Check the circuit breaker of the protection system

Check the On/Off switch of the turbine Check the safety fuses of the protection

system Check the continuity of the power cable.

Equipment turns on, but there is no emission of water jets

Check if the hose or their connections are not damaged.

Check if the suction of the turbine is not clogged.

Call technical assistance Equipment turns on but the turbine makes noises or vibrate strongly

Call technical assistance

The drainage valve is activated, but the water is not drained

Check if the crank of the valve is not loose Check the hydraulic drainage system

The water level in the tank has lowered substantially during use

Check if the valve is totally closed Check if some small object is preventing the

closing of the valve

Note1: using parts and accessories not specified by CARCI could compromise the equipment safety. CARCI shall not be responsible for such procedure. Note 2: Electric diagrams, circuits and parts lists are not provided to end consumers. If necessary, please contact CARCIs Authorized Technical Service.

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Fuses Replacement Disconnect the protection system of outlet; Press the lack of the fuse holder to low and pull the support; Replacement the open fuse by one of equal valor;

To 127 V~ : 12.5A 250V 20AG To 220 V~ and 230 V~: 6.3A 250V 20AG

If fuse continue opening, contact the CARCIs Authorized Technical

Service. T e ch n i ca l Ch a r a ct er i s t i c s Model 2021 Turbine Function and application :Whirlpool for therapy Directional nipple or direct jet Adjustable level of water aeration Water discharge :220 liters per minute Mains supply :127V~ or

:220V~ ( 10%) (different models)

Mains frequency : 60Hz or 50Hz (different models)

Maximum consumption : 800 VA Mains Fuses 127V : 2x 12.5A 250V 20AG

220V : 2x 6.3A 250V 20AG Motor : 1/2 HP 3450 RPM

: Permanently lubricated Dimensions : 0.89 x 0.27 (H x ) mt. Net weight : 17 kg Protection against electric shock : Class I Degree of protection of the part applied Type B Protection against water penetration : IPX0 Operation mode : Continuous

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This equipment can not be used in presence of flammable anesthetic mixture with air oxygen or nitrous oxide.

Equipment operating conditions: Room temperature : +15C to +40C Relative humidity : 0% to 80% Atmospheric pressure : 700 hPa to 1060hPa Environmental conditions for transportation and storage: Room temperature : -10 to 50oC Relative humidity : 20 to 90% Atmospheric pressure : 500 to 1060hpa

Safety against electric shock risk:

This equipment was built according to standard NBR IEC 60.601-1: 1997 (Electromedical Equipment Part 1 General Safety Prescriptions)

Important remarks T a nk s mod e l s 2 00 1 , 20 02 , 2 00 3 Made of AISI 304 stainless steel Mounted on casters Gate valve, diameter, for water drainage. Polished finishing A c ce s sor i e s : Chair for treatment 2050 Thermometer 2005 Directional nipple hose 2006

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S y mb o l s In the equipment:

Equipment OFF

Equipment ON

This equipment causes physiological effects. See instructions manual.

Type B applied part

Produced date

Serial number

Manufacturer identification

CE Mark and notified body identification

European representative

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In the packaging:

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Electromagnetic Compatibility Information

MANUFACTURERS STATEMENT AND DIRECTIONS ELECTROMAGNETIC EMISSIONS

TURBIMED is intended for use in the electromagnetic environment described below. TURBIMED buyer or operator should make sure that it is being used in this kind of

environment. Emission tests Compliance Electromagnetic environment -

directions RF emission CISPR 11

Group 1 TURBIMED uses RF power only for its internal working. Thus, its RF emission is very low and is not likely to cause any interference in other electronic equipment nearby.

RF emission CISPR 11

Class A TURBIMED is intended for use in all establishments, including household environments and those connected directly to the public power system supplying power to constructions with domestic purposes.

Harmonic emission IEC 61000-3-2

Class A

Voltage Fluctuation / Flicker emission IEC 61000-3-3

Compliant

MANUFACTURERS STATEMENT AND DIRECTIONS ELECTROMAGNETIC

IMMUNITY TURBIMED is intended for use in the electromagnetic environment specified below. TURBIMED buyer or operator should make sure that it is being used in this kind of

environment. Immunity tests IEC 60601 test

level Compliance

level Electromagnetic environment -

directions Electrostatic discharge IEC 61000-4-2

6 kV contact 8 kV air

6 kV contact 8 kV air

The floor should be wood, concrete or ceramic. If the floor is covered with synthetic material, the relative air humidity should be at least 30 %.

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Immunity tests IEC 60601 test

level Compliance


directions Quick transients / Bursts IEC 61000-4-4

2 kV supply line 1 kV signal input and output line

2 kV supply line Not-applicable

The power system quality should be that of a typical hospital or business environment.

Surge IEC 61000-4-5

1 kV differential mode 2 kV ordinary mode

1 kV differential mode 2 kV ordinary mode

Voltage drops, short interruptions and voltage variations in power supply. IEC 61000-4-11

95% drop in Ut) Per 0.5 cycle 40% Ut (60% drop in Ut) Per 5 cycles 70% Ut (30% drop in Ut) Per 25 cycles 95% drop in Ut) Per 5 s

95% drop in Ut) Per 0.5 cycle 40% Ut (60% drop in Ut) Per 5 cycles 70% Ut (30% drop in Ut) Per 25 cycles 95% drop in Ut) Per 5 s

Magnetic fields of network frequencies (50/60 Hz) IEC 61000-4-8

3 A/m 3 A/m The magnetic fields of network frequencies should be characteristic levels of a typical business or hospital environment.

Note: Ut is the voltage of AC network before application of the test level.

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MANUFACTURER STATEMENT AND DIRECTIONS ELECTROMAGNETIC

IMMUNITY TURBIMED is intended for use in the electromagnetic environment specified below. TURBIMED buyer or operator should make sure that it is being used in this kind of

environment. Immunity

tests IEC 60601 test

level Compliance


directions RF Conducted IEC 61000-4-6 RF Radiated IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 V

3 V/m

Portable and movable RF communication equipment should not be used closer to any part of the TURBIMED, including cables, than the separation distance recommended, calculated from the equation applicable to the transmitter frequency. Recommended separation distance

Pd .17,1

Pd .17,1 80 MHz to 800 MHz

Pd .3,2 800 MHz to 2.5 GHz Where P is the maximum transmitter output power in watts (W), according to transmitter manufacturer and d is the separation distance recommended in meters (m). The field generated by fixed RF transmitters, as determined by an electromagnetic field study on sitea, should be less than the compliance level in each frequency range. b Interference may occur around equipment bearing the following symbol:

NOTE 1: within the range of 80 MHz to 800 MHz, the highest frequency in the range is applicable. NOTE 2: this procedure may not apply in all situations. The electromagnetic propagation is affected by absorption and reflection of structures, objects and people.

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a. The intensity of fields generated by fixed transmitters, such as cell sites for phones (cell/wireless) and ground mobile radios, hams, AM, FM radiobroadcast stations and TV may not theoretically have accurate prognosis. In order to evaluate the electromagnetic environment due to fixed RF transmitters, an electromagnetic field study on the site should be considered. If the intensity of field measured at the site in which TURBIMED is used exceeds the compliance level above, TURBIMED should be observed to check if it is operating normally. If abnormal performance is verified, additional measures may be required, such as reorientation or reallocation of TURBIMED;

b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be less than 3 V/m.

Separation distances recommended between portable and mobile RF communication

equipment and TURBIMED TURBIMED is intended for use in electromagnetic environment in which RF disturbances are controlled. TURBIMED buyer or operator can help prevent electromagnetic interference by keeping a minimum distance between portable and mobile RF communication equipment (transmitters) and TURBIMED as recommended below, according to the maximum output power of the communication equipment.

Maximum declared output power of transmitter (W)

Separation distance according to transmitter frequency 150 kHz to 80 MHz

Pd 17,1 80 MHz to 800

MHz

Pd 17,1

800 MHz to 2.5 GHz

Pd 3,2

0.01 11.70 cm 11.70cm 23.00 cm 0.1 37.00 cm 37.00 cm 72.70 cm 1 1.17 m 1.17 m 2.30 m 10 3.70 m 3.70 m 7.27 m

100 11.70 m 11.70 m 23.00 m For transmitters with the declared maximum output power not listed above, the separation distance recommended (d in meters) may be determined by using the equation applicable to the transmitter frequency; where P is the maximum transmitter output power in watts (W) according to its manufacturer. NOTE 1: at 80 MHz and 800 MHz, the separation distance is applied for the highest frequency. NOTE 2: this procedure can be applicable in all situations. The electromagnetic propagation is affected by absorption and reflection of structures, objects and people.

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Final Comments

It has been a policy of CARCI to continuously improve the quality of its products. Carci reserves the right to make changes in the design and specifications, as well as to add and improve its products without any obligation to install them in products already manufactured. The text, illustrations and specifications contained in this manual are based on information available at the time of its printing. All rights reserved. This manual may not be wholly or partially reproduced without written authorization from Carci.

Patent # 7.407.681BR Information on the Manufacturer CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda. CGC: 61.461.034/0001-78 I.E. : 110.182.450.113 Rua lvares Fagundes, 359 So Paulo SP Brasil CEP 04338-000 Tel.: (55 11) 3346 2100 Fax.: (55 11) 3207-8027 e-mail : [email protected] web site : www.carci.com.br

Carci Registration at the Ministry of Health: MS-1.03.142-9 Registration of the Equipment at the Ministry of Health: MS-10311490002 For Technical Assistance: Technical Assistance Department Rua lvares Fagundes, 359 So Paulo SP Brasil CEP 04338-000 Tel.: (5511) 5621 7024 Fax.: (55 11) 5621-2701 e-mail : [email protected] Responsible Technician: Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

Warranty Certificate appended

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EUROPEAN REPRESENTATIVE

OBELIS S.A.

34, Av. de Tervuren, bte 44

B-1040 Brussels, BELGIUM

Tel: (32) 2.732.59.54

Fax: (32) 2.732.60.03

E-mail: [email protected] Bibliographic References Thermal Agents in Rehabilitation Susan L. Michlovitz 3rd ed. 1996

CPR Contemporary Perspectives in Rehabilitation. Elementos de Fisioterapia Araujo Leito 4th Edition 1973 Artenova Therapeutic Modalities Chad Starkey, PhD, ATC 2nd ed. 1993. F.

A. Davis Company Philadelphia.

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