THD Evolution REF 700000 User Manual Rev 11 May 2011

1

2

THD EASY/BASIC

A C

THD SLIDE B 3

4

B A

B

5

6

E F

115V

230V

8

7

I 10

J

K

L

M

N

11

G H A B

C

9

D

12

13

14 215009

Z002514 1209

Z002514 1209

IMPORTANT SAFETY INFORMATION Before installing the THD Evolution, check the voltage setting on the back panel, which must correspond to your country voltage. If it does not, prooceed immediately to set the power supply, as described in Chapter 6 of this manual.

US

SUMMARY INTRODUCTION _ ____________ pag.1

8. CLEANING & STERILIZATION_ __ 12

1. UNPACKING _ _________________ 1

9. MAINTENANCE _ _____________ 12

2. SPECIFICATIONS ______________ 1

10. MOVING & STORAGE _ _______ 13

3. TECHNICAL DATA _____________ 2

11. DISPOSAL __________________ 14

4. SAFETY PRECAUTIONS _________ 6

12. SYMBOLS __________________ 14

5. SYSTEM DESCRIPTION _ _______8

13. LIMITED WARRANTY _ ________ 15

6. INSTALLATION ________________8

14. TROUBLE SHOOTING _ ______ 15

7. OPERATING MODE ___________ 10 US 1

INTRODUCTION Thank you for purchasing this THD EVOLUTION. THD EVOLUTION consists of a Doppler unit and a light source and it is intended for use in treatment by qualified medical specialists, to perform hemorrhoidal dearterialisation treatment of hemorrhoidal disease.

1. UNPACKING The package contains: 1.

User’s Manual and safety certification report

2.

Main Unit (REF 700016)

3.

Fiber-optic cable (REF 880001 - pic.3)

4.

Power cable (REF 320004)

5.

Pneumatic footswitch (REF 880006 - pic.4)

6.

Needle holder (cod. 880003)

2. SPECIFICATIONS THD EVOLUTION This medical hemorrhoidal

equipment disease:

is designed Transanal

for low invasive surgical treatment of Hemorrhoidal Dearterialisation (T.H.D.)

The T.H.D.(1) procedure , using the THD EVOLUTION with THD KIT for Transanal Hemorrhoidal Dearterialisation is easy and fast to perform and is a minimally invasive surgical procedure. 1) For any information concerning the disposable dearterializer THD KIT, refer to the specific user manual.

It can be performed under day-surgery and the patient

local anesthesia, can usually go

in an outpatient clinic or home on the same day.

The latter procedure brings several advantages over traditional surgical techniques since, while being resolutive, is not marred by the same problems such as: pain, post-operative complications and delayed return to normal life-style. THD EVOLUTION must be used with dedicated accessories, which are the THD dearterializer, the fiber-optic cable and the Doppler Probe. The technical characteristics of this unit and of the accessories guarantee a safe, effective procedure. DOPPLER PROBE (Pic.2) It consists of an electro-medical instrument complying with the following standards: IEC/EN 60601-1/CEI 62-5. Specifications: Class I, Type BF (electrical shocking hazard protection). Designed for continuous operation up to 90 minutes. OPTICAL FIBER CABLE (Pic.3) It consists of an OPTICAL FIBER light cable, supplied with a cylindrical connection to connect to the THD Evolution and with a Storz threaded connection to fit the tips which will then be connected with the THD dearterializer.

US 2

3. TECHNICAL DATA Identification Main Unit

Main Unit with accessories (see Chapter 1)

Mandatory accessories

REF 700016

Doppler unit with incorporated light source

REF 800110

Composed of: 700016 - Main Unit 880006 - Foot pedal 320004 - Electric power cable

REF 700001;700012

Doppler Transducer THD DEVICE PROCT.

REF 880056;880063

Doppler Transducer THD SLIDE - EASY

REF 880001, 880002, 880004, 880007

Fiber-optic cable with/without changeable tips.

Electrical Specifications Voltage

~ 115VAC / 230VAC (±10%)

Absorption

100 VA

Frequency

50 / 60 Hz

Electrical shock protection

Fuses (2 external + 2 internal)

115 V: 2x1.6 A (external) 20x5 fast 230 V: 2 x 0.8 A (internal) 20x5 fast

Isolation

Class

I

Display

LCD Matrix

2 row x 20 column (to scroll), backlight

Type

Filament, faston connector, Osram SIG64004.

Voltage

~10 V

Absorption

50 W

Voltage

~110 ÷ 220 V

Absorption

12 W

Power supply

Lamp (internal)

Fan

Electrical Specifications

Doppler Module

Transmitted Frequency

8 MHz

Type of emission

Continuous wave

TX Power

600 mW / 50 ohm

RX Dynamic range

> 100 dBm

Audio bandwidth

300÷2000 Hz

Audio-power

12 W / 8 ohm

Headphone

0.5 W/ 32 ohm

Temperature

50÷86 °F (10÷30 °C)

US

Environmental conditions Operation

Humidity

max 70%RH a +86 °F

General

Hospital-type environment

Temperature

32 ÷ +104 °F (0 ÷ +40°C)

Humidity

max 70%RH a +86 °F

Type of equipment

Risk Class

IIa (according to 93/42/CE)

Isolation

Type

BF (according to IEC/EN60601-1)

Protection against external agents leaking

IP-Grade

IPX0 (according to IEC/EN60529)

Storage Medical Compliance

Usage in presence of anaesthetic gases

No

Working conditions

Suitable for continuous operation

Mechanical specifications

US 3

Regulatory

Dimensions

L 34 cm W 30 cm H 17 cm

Weight

6Kg (13 lbs)

93/42 EU Directive IEC/EN60601-1:1998-12

IEC 60601-2-37: 2002-11

Acustic Output Reporting Table Acoustic Output

MI

Ispta3 (mW/cm2)

Isppa3 (W/cm2)

pr.3 (Mpa)

Wo (mW)

fc (MHz)

Zsp (cm)

Beam Area (mm2)

Mean value:

0.026

234

0.234

0.0746

17.26

8

0.70

Standard Dev.:

0.0066

116

0.116

0.0192

0.0862

0

Max Value:

0.032

347

0.347

0.092

17.36

8

ISPTA.3 ISPPA.3 MI pr.3

is the derated spatial-peak temporal-average intensity (mW/cm2). is the derated spatial-peak pulse-average intensity (W/cm2). is the Mechanical Index. is the derated peak rarefactional pressure (MPa) associated with the transmission pattern giving rise to the value reported under MI. is the ultrasonic power (milliwatts). is the centre frequency (MHz). is the axial distance at which the reported parameter is measured (cm). is the pulse duration (microseconds). is the pulse repetition frequency (Hz). is the entrance beam dimensions for the azimuthal and elevational planes (cm). This parameters for contact transducer as THD Evolution probe can be taken as the dimension of the radiating

Wo fc zsp PD PRF EBD

PD

PRF

EBD

2.66

-

-

(*)

0.15

0.18

-

-

(*)

0.8

2.84

-

-

(*)

In continuous wave operating mode, ISPTA.3 and ISPPA.3 intensity parameters have the same value Acoustic output uncertainties Parameters

U%

Intensity (ISPTA, ISPPA)

30%

Pressure (pr)

15%

MI

15%

Output Power

7.0%

The derated value of the parameters are calculated for an average reduction assumed to be 0,3 dB MHz-1 cm-1. For pressure parameters: p.3=p ·10 (-0,05 · 0,3 · f · z) and for intensity parameters: US 4

I.3=I 10 (-0,1 · 0,3 · f · z)

Guidance and manufacturer’s declaration – electromagnetic environment The THD Evolution equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the THD Evolution should assure that it is used in such an environment. Emission Test

RF Emission CISPR 11

Compliance

Electromagnetic enviroment guidance Group 1

RF Emission CISPR 11

Class B

Harmonic emission IEC 61000-3-2

Class D

Voltage fluctuation/flicker emission IEC 61000-3-3

Compliant

The THD Evolution uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The THD Evolution is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity The THD Evolution equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the THD Evolution should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Electrostatic discharge (ESD)

Compliance level

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode

<5 % UT (> 95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UV) for 5 cycles 70 % UT (30% dip in UT) for 25 cycles <5 % UT (> 95% dip in UT) for 5 sec

<5 % UT (> 95% dip in UT) for 0,5 cycle 40 % UT (60% dip in UV) for 5 cycles 70 % UT (30% dip in UT) for 25 cycles <5 % UT (> 95% dip in UT) for 5 sec

3 A/m

3 A/m

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency and magnetic field (50/60 Hz) IEC 61000-4-8

Electromagnetic enviroment guidance

Power quality be that of a commercial or environment.

should typical hospital

Power quality be that of a commercial or environment.

should typical hospital

Mains power quality should be that of a typical commercial or hospital environment. If the user of the THD EVOLUTION requires continued operation during power mains interruptions, it is recommended that the THD EVOLUTION be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note UT is the a.c. mains voltage prior to application of the test level. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic enviroment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the THD EVOLUTION, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.16√P

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 Veff

d=4 √P

from 80 MHz to 800 MHz

d=2.33 √P

from 800 MHz to 2,5 GHz

3 V/m Radiated RF IEC 61000-4-3

80 MHz to 2,5 GHz

3 V/m

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

US

US 5

Note: (1) At 80 MHz and 800 MHz, the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a - Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the THD EVOLUTION is used exceeds the applicable RF compliance level above, the THD EVOLUTION should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the THD EVOLUTION. b - Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the THD EVOLUTION The THD EVOLUTION is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the THD EVOLUTION can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the THD EVOLUTION as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter d=1.16√P 150 kHz to 80 MHz

US 6

d=4√P 80 MHz to 800 MHz

d=2.33√P 800 MHz to 2,5 GHz

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

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Notes: (1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. (2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

4. SAFETY PRECAUTIONS Indications: The THD doppler guided proctoscope is a system for the surgical treatment of hemorrhoids. It is based on the Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoidal artery, in order to perform the artery ligation with a proctoscope, sutures and a needle holder included in the THD disposable kits. The THD must be used by physicians in hospitals, clinics, and physicians’ offices by prescription or doctor’s orders. Contraindications: None

Patient Restrictions: The THD (EVOLUTION & KIT) must not be used on patients under 14 years of age or in patients with severe rectal inflammation. The use of the device on pregnant women has to be carefully evaluated by the referring physician. Warnings: • Failure to follow these instructions could lead to damages or malfunctioning of this unit. • The instrument contains sophisticated electronic components, which guarantee its high sensibility, and can therefore be disturbed by strong radiofrequency fields. The existence of such disturbances are indicated by unusual noises from the loudspeaker or by a temporary audio muting. The source of interference should be identified and eliminated. • The THD EVOLUTION unit and its accessories can only be connected with sockets compliant with the CEI 64/8 normative (sockets protected against micro shock risk). • THD EVOLUTION must only be used in accordance with what is specified in Chapter 3, TECHNICAL DATA section titled, “Environmental conditions”; otherwise there may be risks of lesions, damages or malfunctioning. • Make sure that both the fiber-optic cable and the non sterile Doppler Probe HAVE BEEN CLEANED AND STERILIZED BEFORE CONNECTING THEM (for sterilization information refer to respective user manuals). Connection has to be carried out while safeguarding sterility. • THD EVOLUTION is intended for use with Transanal Dearterializer THD (Pic.1), Doppler Probe (Pic.2), Fibre-optic Cable (Pic.3), Foot pedal (Pic.4) and Knot-pusher (Pic.1). • Never pull, rotate or press on the power cable too strongly as this may damage it. • Never use the THD EVOLUTION in proximity of flammable gases. Use in such an environment could start a fire. • Keep the THD EVOLUTION away from liquid substances to prevent electric shock or malfunctioning. Although the unit is protected from accidental contact with liquid substances, in the event of any contact, disconnect the unit from the power supply. Dry the external housing (See “Cleaning and Sterilization” Chapt. 8 and 9) and make sure any liquid substances that may have penetrated inside have not damaged the functionality. • Burn hazard: Make sure that the unit is switched off for at least 30 minutes before opening the external housing. • Do not remove cap on plug end of the doppler in sterile field. Precautions: • The unit has to be placed on a flat and stable surface, far from heat sources (like monitors, light sources, etc.), otherwise it could get overheated. • Make sure that the power supply is compatible with the electrical specifications of the unit; use the supplied power cable only. • Power cord, Doppler Probe and fiber-optic cables have to be intact. Do not use the THD EVOLUTION if any of its accessories is broken or damaged. • Periodically check the accessories. In case of wear or damage, replace them immediately. Make sure that the THD EVOLUTION is not used near high frequency equipment (electrical scalpels, cellular phones, x-ray machines etc.). This could interfere with the Doppler function. • THD EVOLUTION must be serviced by the THD S.p.A. service department or by a THD S.p.A.-authorized dealer’s service center; otherwise the validity of the warranty will expire. • In order to pull out the removable parts from the designed lodging (Doppler probe, fiber-optic, etc), always use the rigid part. Do not pull on the cable, the accessory could be damaged. • Handle the Doppler Probe body with care, avoid any mechanical shock. Read Chapter 5 for additional Information regarding the probe.

US

US 7

5. SYSTEM DESCRIPTION

THD EVOLUTION Front Panel - Display (Pic. 6) A) Headphone socket B) Volume knob C) Doppler probe socket D) Fiber-optic cable connector E) Display F) START key G) STOP key H) INFO key

US 8

Back Panel (Pict. 7) I) Power cord socket J) On/off switch K) Fuses - Change voltage L) Equipotential connector M) Labelling N) Pneumatic footswtich socket

DOPPLER PROBE (Pic.2) Body probe (A) The doppler probe is an electro-acoustic transducer. The probe is shaped to fit into the slot of the THD dearterialiser. It is made of medical grade plastic and guarantees excellent electrical insulation. Internal wiring is wrapped in epoxy resin. Connector (B) The connector encloses four signal pins and the earth pin. Cable (C) The cable consists of two coaxial wires within an external insulating sheath. FIBER-OPTIC cable (Pic.3) The fiber-optic cable consists of: • an aluminium cylindrical connector (A) to the THD EVOLUTION; • the fiber-optic cord (B), 200 cm long, within a silicone sheath; • a Storza type threaded stainless steel metallic connector (C) where the tips that will lodge on the THD dearterialiser handle are plugged in.

6. INSTALLATION

While installing the THD EVOLUTION follow all the safety precautions listed in Chapter 4. The unit has to be placed on a flat and stable surface, far from heat sources (like monitors, light sources, etc.), otherwise it could get overheated.

Make sure that the power supply is compatible with the electrical specifications of the unit. Follow these steps:

US

1. 2.

Check the factory setting of the power supply (see Pic.5-I) If it corresponds to your country’s power voltage, you can proceed with installation; if it does not correspond (e.g. power setting 230 V, while your country power voltage is 115V), it is necessary to proceed as follows: 3. Open the lid by using a flat screwdriver (a) (Pic.5-I) 4. Pull out the fuse box (Pic.5-II) 5. Pull out the power switch (Pic.5-III) 6. Rotate the lever 90°counter-clockwise until the correct value (230 o 115) is shown (Pic.5-IV) 7. Reinsert the power switch 8. Reinsert the fuse box 9. Check that the value visible from the window corresponds to the selected one (230V or 115V) 10. You can now proceed with installation.

Power cord, Doppler Probe and optic fiber-optic cable must all be undamaged. A damaged cable could be hazardous or cause malfunctioning, in this case do not use THD EVOLUTION.

EQUIPOTENTIAL CONNECTOR (Pic.7-L) When available, connect the THD EVOLUTION to the equipotential network of the operating room (whose compliance to safety regulations is the end-user’s sole responsibility) through the connector on the back panel of the THD EVOLUTION. CONNECTION TO A POWER SOURCE (Pic.8 - I) Before plugging in the power cable, check that the main switch, placed on the back panel, is in the “0” (off) position. The power cable must be firmly inserted both in the wall socket and in the power socket, on the back of the unit.

Never pull, rotate or press on the power cable too strongly, it may be damaged; use only the supplied cable.

CONNECTION OF THE PNEUMATIC FOOT PEDAL (Pic.7-N and Pic.8 - N) The pneumatic connection of the footswitch (a rubber pipe) has to be plugged into the dedicated socket on the back panel (identified by a normalised icon). It is recommended to cover the footswitch (for instance with a non-sterile glove) to keep it clean during the procedure.

US 9

7. OPERATING MODE WARNING: before using the THD EVOLUTION it is necessary to have carefully followed the instructions listed in Chapter 6 “Installation”. Make sure that both the fiber-optic cable and the Doppler Probe have been cleaned and sterilized before connecting them (for sterilization information refer to Chapt. 8). Connection has to be carried out while safeguarding sterility.

CONNECTION OF THE FIBER-OPTIC CABLE ( Pic.9 - B and Pic.10 - A) The cylindrical fiber-optic connector (Pic.3-A) must be inserted in the appropriate lodging (identified by a normalised icon) placed on the front panel of the unit until it locks in (Pic.9-B). The metal tip on the other end of the fibre-optic cable (Pic. 3-C) must be firmly connected to the end tip, which will lodge in the THD Dearterializer (Pic. 10-A).

US 10

DOPPLER PROBE CONNECTION (Pic.9 -A and Pic.10 -B) 1. Turn on the unit by putting the main switch to position “1” (Pic.11). 2. Verify that the display turns on (Pic.6-E). 3. Verify that the cooling fans, inside the unit, turn on. 4. After a few seconds, the display will show the following message: THD EVOLUTION The painless surgery for HEMORRHOIDS Insert Transducer 5. The Doppler probe must first be inserted in the appropriate rectangular slot on the side of the dearterializer THD (Pic.10-B). 6. The Doppler Probe cable connector must be inserted in the appropriate socket (identified by a normalised icon) placed on the front panel of the unit (Pic.9-A). 7. The display will show the following message(*): Usable surgery:# Transducer OK Press START when Ready When ready to start the procedure, press START (►) (Pic.6-F). 8. Pressing START the message: TIME: 90:00 appears on the display; the light source turns on and the Doppler will be on; the typical Doppler ground noise will be heard. Check that the inside of the Dearterializer THD is lit by the fibre-optic cable. 9. Adjust the Doppler output volume to the desired value (Pic.6-B). 10. One minute before the end of the procedural time, an acoustic alarm will sound. 11. At the end of the procedural time, both the Doppler and the light source are turned off and the display will show the following message: TERMINATED PROCEDURE! Please remove transducer 12. Wait at least 5 minutes before turning off the equipment and/or disconnect it from the mains to allow for a proper cooling of the lamp assembly. 13. Switch off the unit at the end of each procedure, by placing the switch button on the back panel on the “0” position (Pic.11). Wait at least 30 sec. before switching on the unit again. In case of malfunction, switch the unit off and refer to Chapter 13 of the manual. If the problems persist, contact your THD dealer. (*) When the display shows the message: “Surgery limit reached, please insert a new transducer!”, and/or DUMMY PROBE: OK!, the Doppler probe has terminated its life. Replace the probe with a new one.

Make sure that the Doppler and fiber-optic cables position do not obstruct the user during the procedure and that they can not be crushed.

US

The Doppler audio volume can be adjusted by rotating the knob on the front-panel. The volume is increased by clockwise rotation. The footswitch turns on and off the doppler signal. It does not affect the Doppler volume setting. Switch off the unit after all procedures, to extend its work life. For matters concerning the technique of the surgical procedure and the use of the Dearterializer THD, please refer to the manual provided with THD kits.

WARNING: Do not disconnect either the Doppler Probe or the fiber-optic cable while the unit is on.

Menu Display (OSD) The THD EVOLUTION display provides some simple info (in several languages). Please read below how to access this info. To exit from any menu press the STOP(■) button. Keys and their function:(►) START/CONFIRM, (■) STOP/EXIT, (i) INFO/SCROLL STATUS INFORMATION Pressing INFO, the

display will show the following message: Maintenance Menu System Info Pressing START (►) the display will show the following system status info: Lamp hours:xx Temp:xx °C Sw.rev. 1.0 Pressing STOP (■) the display will revert to System Info Keeping pressed the (i) button, the following menus will alternate on the display: System Info > Language Selection > Audio Options> Reset Lamp Counter LANGUAGE SELECTION Press INFO (i) to display Language Selection, press START (►) to select the submenu, look for the desired language by pressing INFO/SCROLL (i), select by pressing START (►). All the menus will now be displayed in the selected language. AUDIO OPTIONS Press INFO (i) to display Audio Options, press START (►) to select the sub-menus: Speaker + Headphones > Headphones only, select the desired setting with START (►). RESET LAMP COUNTER (see Chap.9 - Maintenance)

US 11

8. CLEANING AND STERILIZATION THD EVOLUTION

WARNING: Always disconnect the power cord before cleaning. Do not dip the THD EVOLUTION in water or in a detergent solution, nor autoclave or gas-sterilize it. Do not use cleaning and disinfecting methods which might cause moisture to form inside the unit.

The unit can be cleaned with a soft cloth or gauze, soaked in an enzymatic substance or another EPA registered disinfecting agent. Make sure that liquid substances do not drip inside the unit, while cleaning. Dry with a soft, clean, dry cloth. Abrasive materials are not to be used. Follow the same instruction to clean the foot pedal, which does not require sterilisation. US 12

For cleaning and sterilization the accessories refer to their user manual.

9. MAINTEINANCE Servicing on the main unit (except for the below listed activities) can only be carried out by THD Spa. The user can only do the following: • LIGHT-BULB REPLACEMENT • FUSES REPLACEMENT (115 VAC only) LIGHT-BULB REPLACEMENT WARNING: before performing any of the steps listed below, make sure that the main switch is in the “0” position and the power cable disconnected.

WARNING: burn hazard: Make sure that the unit is switched off for at least 30 minutes before opening the external housing.

Replacement of the light bulb must be carried out by an expert. It is recommended to replace the light bulb after 2,000 hours of operation, or when broken or exausted. The replacement bulb must be new and identical to the one replaced (Ref. 880005)(Pic.12-13).

US

1. 2.

Turn the unit upside/down. Open the cover by pressing with a screwdriver on the plastic lid (Fig.12A-B). Unscrew the three screws visible on the metallic surface underneath (Fig.12C). 3. Pull out the bulb case (Fig.13A). 4. Disconnect the two faston connectors and replace the bulb (Fig.13B-C). 5. Reposition the new bulb in its housing, reconnect the faston, reinsert the bulb case and fasten the three screws. 6. Close the cover and rotate the unit back. 7. Connect the unit to the mains. 8. Reset Lamp Counter: press INFO/SCROLL (i) until the message: Reset Lamp Counter is displayed. 9. Press START (►) , confirm by pressing START (►), again. Display: Lamp Counter = 0! 10. Verify that the ligth bulb works properly.

If the problem persists, contact your authorized THD dealer. FUSES REPLACEMENT (external 115 VAC fuses only) Open the fuse-box, placed on top of the main switch on the back panel (Pic. 7-K) by using a screwdriver. Pull out the fuses and replace them with new ones with identical characteristics. The internal fuses of 220 V can be only replaced by THD technical support. If the problem persists, contact your authorized dealer.

WARNING : The main unit should be periodically checked by the final user, in order to verify the electrical safety (recommended every year) in accordance with the terms of the EN 60601-1 standard.

10. HANDLING AND STORAGE Store the unit in a dry, clean, ventilated location, at a temperature between 32°F (0°C) and 104°F (40°C). Keep away from the sunlight, rapid temperature variations, and high humidity. Storing at temperatures outside of the suggested range may cause the unit to be damaged. Do not bend or rotate the fiber-optic cable and the Doppler Probe at sharp angles. They must be packaged loosely as in the original packaging. Do not store the unit using the original cardboard box. When moving the unit to a different site, use the original cardboard box complying with the same environmental conditions as per storing.

US 13

11. DISPOSAL THD EVOLUTION does not contain materials deemed “hazardous” according to the current normative.

USER COMMUNICATION : accordingly with art. 13 of the Legislative Decree dated 25th July 2005. n. 151 “Implementation of the Directives 2002/95/EC, 2002/96/EC and 2003/108/EC, concerning the reduction of use of dangerous substances in the electronic and electric equipment as well as the waste disposal”. The symbol of the crossed-out waste bin, which is applied on equipment or packaging, shows that the product must be collected separately from other waste at the end of its useful life.

US 14

The differential collection of this equipment, that has come to the end of its life, is organised and managed by the manufacturer. Therefore, the user wishing to dispose of this equipment must contact manufacturer and follow the system used by the latter, so that the equipment that has come to the end of its life, can be collected separately. Appropriate separate collection for the later sending of the discarded equipment for recycling, treatment and environmentally compatible disposal contributes to avoiding possible negative effects on the environment and on health and supports reuse and/or recycling of materials the equipment is made up of. Illicit product disposal by owners of the product will lead to the application of financial penalties as per the rules in force.

12. SYMBOLS

Symbol

Meaning BF Applied part Equipotential connection Pneumatic footswitch connection

13. LIMITED WARRANTY THD S.p.A. grants the User a 1 year warranty, starting from the date of purchase. Within this warranty period, THD S.p.A. will solve any defects in the THD EVOLUTION unit and its accessories resulting from faults in material or workmanship.

US

Faced with justified claims, THD S.p.A. or the local authorized dealer will repair or replace the faulty product at no cost. All other claims, of whatever type, are excluded, including specifically any damage-claims. Damages and/or wounds and their consequences derived from the following are not covered by this warranty: - excessive use - improper use (any use other than what reported in this booklet), negligence or fraud - inobservance of the instructions for use, for installation or for maintenance. - anomalous chemical, electrical or electrolytic contamination. - poor electrical connections The disposable THD KIT-THD SLIDE and the light bulb are not covered by this warranty. This warranty becomes null and void if servicing is carried out by unauthorized persons and if the unit is used together with accessories other than those specifically designed. This warranty comes into force only in the presence of the original invoice (or packing list) clearly stating the date of purchase, the product’s reference number on the Doppler and the Fiber-optic (Pic.14-A and B), and the product’s serial number (Pic. 14-C).

14. PROBLEM SOLVING PROBLEM

POSSIBLE CAUSE Power cable disconnected from the wall socket or from the unit power socket, placed on the backpanel of the THD EVOLUTION

The switch-on light, on the frontpanel, does not come on.

Doppler sound absent or too low.

SOLUTION Check both the connections and insert both plugs firmly.

Main switch not in the on “I” position.

Switch it on.

The protection fuse is burned

Disconnect the power cable. Open the fuse box and replace the fuse(s). (see chapter 9)

Broken power cable.

Replace the cable

Wall socket not under voltage.

Have the electrical circuit checked by an expert.

Main switch of the THD EVOLUTION off (0).

Switch it on.

Foot-pedal muting

Press the pedal once or few times

Volume knob

Rotate the knob clockwise.

Doppler Probe not well connected

Verify the connection (see chapter 6).

Doppler Probe broken

Replace the Doppler Probe

US 15

PROBLEM

POSSIBLE CAUSE

Switch them off.

Doppler sound absent or too low.

Presence of high frequency emitters in the proximity (electrical scalpels, cellular phones, x-ray equipment, etc). Broken or exhausted bulb.

Replace the bulb (see chapter 9)

Bulb dislodged from its brackets

Lodge the bulb back in position. (see chapter 9)

Fiber-optic cable not well connected.

Verify the connection (see chapter 6).

Fiber-Optic of the cable broken or damaged

Replace the fiber-optic cable

The protection fuse is burned

Disconnect the power cable. Open the fuse box and replace the fuse(s). (see chapter 9)

Main switch of the THD EVOLUTION off (0).

Switch it on.

Not enough air to the air vent.

Move the unit to leave the air vent free

Cooling fans blocked by dust

Disconnect the power cable. Clean the cooling fans

Absence or attenuation of the illumination

Overheating

US 16

SOLUTION

The unit looks damaged Any other problem

Contact your local dealer.

The suggested solutions have not solved the problem

(*) The THD EVOLUTION is fitted with an automatic “MUTING” function (automatic cutting out of the audio output) if its level get too high; the audio output is restored after 1-2 sec. In case of longer interruptions, also check the power line for possible disturb. THD S.p.A. will not be liable for any damages occurring, due to an improper use of this unit. For any further information regarding the content of this manual or the use and safety rules of this manual, please contact the Manufacturer or your local dealer. THD S.p.A. is not to be held responsible for damages caused by any use of the THD kits and THD EVOLUTION (or its accessories), other than the one indicated in this manual. Manufacturer: Customer service (USA): THD S.p.A. THD America, Inc. Via Industria, 1 8920 Brittany Way 42015 Correggio (RE) Tampa, FL 33619 ITALY T: (813) 629-0300 Toll Free: 866-374-9442 web: www.thdamerica.com

REF 370013 - Rev.11/05/2011