REVOLUTION Users Manual Rev H June 2015

CONTENTS INTRODUCTION

EN 1

1. PACKAGE CONTENT

EN 1

2. CHARACTERISTICS

EN 2

3. TECHNICAL DATA

EN 2

4. INTENDED USE

EN 7

5. INSTALLATION

EN 8

6. DESCRIPTION OF THE DEVICE AND ITS CONTROLS

EN 9

7. DIRECTIONS FOR USE

EN 9

8. CLEANING AND STERILIZATION

EN 11

9. MAINTENANCE

EN 12

10. TRANSPORT AND STORAGE

EN 12

11. DISPOSAL

EN 13

12. SYMBOLS

EN 13

13. WARRANTY CONDITIONS

EN 14

14. TROUBLESHOOTING

EN 14

IMPORTANT SAFETY INFORMATION Before using the device, carefully read through this manual in order to become familiar with the operating instructions.

EN

INTRODUCTION Congratulations on purchasing the THD REVOLUTION. The THD REVOLUTION device combines a Doppler unit with a light source and is dedicated to the treatment of hemorrhoidal disease. It must be used by qualified and trained medical staff able to perform ligation of the hemorrhoidal arteries in the presence of anorectal hemorrhoids. Identification data Device

Code 700017

Doppler unit with incorporated light source

Device with accessories

Code 800133

Composed of: 700017 - Device 880006 - Pedal 320004 - Power cable 880012 - Curved fiber-optic cable 750001 - Multi-use needle holder Backup probe (single-use Doppler probe 800063 or 5 times reusable Doppler probe 800056)

Code 800056

5 times reusable Doppler probe

Code 800063

Single-use Doppler probe

Code 880013

Straight fiber-optic cable

(see Section 1)

Interfunctional device accessories

1. PACKAGE CONTENTS When opening the cardboard box, check that all the items listed below are included and that none of them are damaged: •

1

THD REVOLUTION user manual

•

1

Electrical safety test report

•

1

Device

•

2

Curved fiber-optic cables with manual (Fig. 4)

•

1

Backup probe (single use or 5 times reusable)

•

1

Power cable

•

1

Pedal (Fig. 5)

•

1

Reusable steel needle holder

EN 1

2. CHARACTERISTICS

THD REVOLUTION (Fig. 1) The THD REVOLUTION is a device that uses an innovative and minimally invasive approach in the surgical treatment of hemorrhoids: transanal hemorrhoidal dearterialization (THD). Use of the THD REVOLUTION device and the THD KIT associated with the THD technique(1) for transanal dearterialization is an easy, fast and minimally invasive procedure. The operation can be performed as outpatient surgery. The THD REVOLUTION is used in conjunction with dedicated instruments, such as the THD KIT, the fiber-optic cable and the Doppler probe. The particularity of the system and the characteristics of the accessories make this technique safe and effective. The THD Revolution can be used in “Light Source” mode to allow the doctor to perform inspections using the numerous THD devices available for proctology (anoscopes, proctoscopes, rectoscopes, etc.) BACKUP DOPPLER PROBE (Fig.3) The Doppler probe is a Doppler transducer that is an applied part of the device. The probe is electrically isolated and is a BF type applied part. Refer to the relative manual supplied with the product for the proper use of the Doppler probe. The backup probe provided is to be used as a substitute in case the one being used malfunctions. In case of the single-use backup probe (800063), check its expiry date. Make sure that you have it on hand before beginning any operation. If you do not have one available, contact THD S.p.A. and request a new one. FIBER-OPTIC CABLE (Fig. 4) It is composed of a fiberglass light guide, one end fitted with a cylindrical connector for connection to THD REVOLUTION and the other end with a stainless steel tip for connection to the THD surgical devices.

1) For the THD dearterializer, refer to the THD KIT user manual

3. TECHNICAL DATA

Electrical properties Voltage

~115 / 230 V ±10%

Absorption

100 VA

Frequency

50 / 60 Hz

Overcurrent protection

Fuses

2x1.6 A (external) 20x5 fast

Insulation

Class

I

Display

Dot matrix

2 lines x 20 characters (scrolling), backlit

Power supply

EN 2

Electrical characteristics

Doppler module

Frequency

8 MHz

Emission

Continuous

TX power

600 mW / 50 ohm

RX sensitivity

> 100 dBm

Audio band

300-2000 Hz

Audio power

12 W / 8 ohm

Headset

0.5 W/ 32 ohm

Temperature

10-30 °C

EN

Permitted environmental conditions Operating

Humidity

Max 70%RH at +30°C

General

Hospital environment

Temperature

0-40°C

Humidity

Max 70%RH at +30°C

Device type

Risk class

IIa (according to 93/42/EC)

Protection against contact

Type

BF (according to IEC/EN 60601-1)

Protection against substance penetration

IP degree

IPX0 (according to IEC/EN 60529)

Storage Electromedical characteristics

Use in the presence of anaesthetic gases

No

Conditions of use

Suitable for continuous operation

Mechanical characteristics

Regulatory and standard compliance

Dimensions

L. 34 cm - D. 30 cm - H. 17 cm

Weight

3.5 kg

Directives: 93/42/EC and subsequent amendments IEC/EN 60601-1:1998-12

IEC 60601-2-37: 2002-11

Acoustic 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). the Mechanical Index. the derated peak rarefactional pressure (MPa) associated with the transmit pattern giving rise to the value reported under MI. the ultrasonic power (milliwatts). the centre frequency (MHz). the axial distance at which the reported parameter is measured (cm). the pulse duration (microseconds). the pulse repetition frequency (Hz). the entrance beam dimensions for the azimuthal and elevational planes (cm). This parameter for contact transducer as THD REVOLUTION 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

-

-

(*)

EN 3

In continuous wave operating mode ISPTA.3 and ISPPA.3 intensity parameters get 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 attenuation assumed to be 0.3 dB MHz-1 cm-1. For pressure parameters: p.3=p ·10 (-0.05 · 0.3 · f · z) (-0.1 · 0.3 · f · z) and for intensity parameters: I.3=I 10

ELECTROMAGNETIC IMMUNITY AND EMISSIONS Guidance and manufacturer’s declaration – electromagnetic emissions Emissions test

Compliance

Electromagnetic environment

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions 61000-3-2

Class D

Voltage fluctuations/Flicker emissions - IEC 61000-3-3

Compliant

THD REVOLUTION uses RF energy only for its internal operation. Therefore, its RF emissions are very low and not likely to cause interference in nearby electronic equipment. THD REVOLUTION is suitable for use in all establishments, including domestic establishments and those directly connected to a public low-voltage power supply network.

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

EN 4

Immunity test

IEC 60601 test level

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

Electrical fast transient/ burst IEC 61000-4-4

±2 kV for er supply ±1 kV for put/output

Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

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

Compliance level ± 6 kV contact ± 8 kV air

powlines inlines

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

powlines

Mains power quality should be that of a typical commercial or hospital environment.

± 1 kV differential mode ±2 kV common mode

± 1 kV differential mode ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (> 95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) 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 UT) 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

±2 er

kV for supply

EN

Mains power quality should be that of a typical commercial or hospital environment. If the user of THD REVOLUTION requires continued operation during power mains interruptions, it is recommended that THD REVOLUTION be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.

Note UT is the AC mains voltage prior to application of the test level

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of THD REVOLUTION, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

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

3 Veff 150 kHz to 80 MHz

d=1.16√P 3 Veff

d=2.33 √P 800 MHz to 2.5 GHz

3 V/m 80 MHz to 2.5 GHz

d=4 √P 80 MHz to 800 MHz

3 V/m

where P is the maximum output power 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 survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:

EN 5

Notes: (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 THD REVOLUTION is used exceeds the applicable RF compliance level above, THD REVOLUTION should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating THD REVOLUTION. 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 THD REVOLUTION THD REVOLUTION is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of THD REVOLUTION can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and THD REVOLUTION as recommended below, according to the maximum output power of the communications equipment. Rated maximum output of transmitter (W)

Separation distance according to frequency of transmitter (m) d=1.16√P d=4√P d=2.33√P 150 kHz to 80 MHz

80 MHz to 800 MHz

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 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.

EN 6

4. INTENDED USE THD REVOLUTION is intended to be used for the surgical treatment of haemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique. The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD REVOLUTION device and the compatible single-use THD kits. THD REVOLUTION and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorrhoidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD REVOLUTION, it can be used in modality “Light Source”, to support the different THD diagnostic devices.

EN

Operating environment:

The THD REVOLUTION device must be used in hospital and outpatient environments suitable for performing anal surgery and in the conditions specified in the section TECHNICAL DATA under “Permitted environmental conditions”. Failure to comply with these instructions means exposing installers, patients and users of the device to the risks of injury and harm as well as compromising device operation.

Contraindications:

There is no known contraindication.

Limits of use: THD REVOLUTION shall be used only in association to diagnostic and surgical THD anoscopes, THD rectoscopes and THD proctoscopes. THD REVOLUTION and its accessories may not be used in patients: • under the age of 14. • in patients with severe rectal inflammation. • the use of the device on pregnant women has to be carefully evaluated by the referring physician • for a scope different from what is indicated in the intended use of the product

Warnings: • •

• • • • • •

•

Carefully read through this manual; failing to do so may cause harm to the patient and/or the user or damage to or malfunctioning of the device. The device contains sophisticated electronic components that ensure high sensitivity and it may hence be disturbed by particularly strong radio frequency fields. The existence of such disturbances is indicated by the speaker emitting unusual sounds or temporary audio interruption. It is advisable to identify and eliminate the source of interference. THD REVOLUTION and its accessories may only be connected to systems compliant to CEI 64/8 (systems protected against the risk of micro shocks) Make sure that the fibre-optic cable and the Doppler probe have been cleaned and sterilized before connecting them (see Section 8 for the sterilization information). Make the connections using an aseptic technique. THD REVOLUTION may ONLY be used with the THD transanal dearterializer (Fig. 2), Doppler probe (Fig. 3), fibre-optic cable (Fig. 4), pneumatic pedal (Fig. 5) and knot pusher (Fig. 2) and compatible diagnostic and/or surgical compatible devices manufactured by THD S.p.A. Do not pull, twist, bend or grip the power cable with excessive force. Never use THD REVOLUTION in the vicinity of flammable gases, as this may cause flames. Keep THD REVOLUTION away from liquids to prevent electric shock or malfunctioning. Even though the device is protected against accidental spillage of liquids, should this occur, it is advisable to disconnect the power supply, dry the casing (see Section 8 “Cleaning”) and check that any liquids that may have penetrated the device have not compromised its functionality. According to the intended use of the device (see “Intended use”) the operating time of the ultrasound Doppler probe should be reduced to as low as reasonably practicable (ALARP).

EN 7

5. INSTALLATION

Do not use the device if one of its components (power cable, Doppler cable, fibreoptic cable etc.) has deteriorated or is not in perfect conditions. Regularly check their condition and if deteriorated, immediately replace them.

Make sure that the mains power is compatible with the electrical characteristics of the device. EXCLUSIVELY use the cable provided with the device and never pull, twist, bend or grip the power cable with excessive force.

Make sure that no high-frequency devices (electric scalpels, mobile phones, X-ray units, etc.) are on in the immediate vicinity of THD REVOLUTION. This may result in malfunctioning or disturbances to the Doppler device.

Do not use in oxygen-rich environment

• • • • •

The device must be positioned on a flat and stable surface; do not place it on a heat source (e.g. monitor, light source, etc.) as this could cause overheating. To extract the removable parts from their seats (Doppler probe, fibre-optic cable, etc.) always use the rigid part and never pull on the cable for any reason as you may damage the accessory. Warning: Do not turn the Doppler probe connector while extracting it. The connector has a reference catch which would irreparably be damaged if turning the connector while extracting it. Handle the probe body (Fig. 3) with extreme care and protect it against impact. Warning: Impact may irreparably damage the transducer.

EQUIPOTENTIAL CONNECTOR (Fig. 7-L) If available, connect THD REVOLUTION to the equipotential network of the facility using the dedicated connector on THD REVOLUTION. The user is responsible for checking that the electric system of the facility complies with the safety requirements. CONNECTING TO THE POWER SUPPLY (Fig.8) Before connecting the power cable, check that the main switch on the rear of the device is in position “0”. Securely insert one end of the power cable in the wall socket and the other end in the dedicated housing on the rear of the device. Turn on the THD REVOLUTION and check if the screen turns on and shows characters. CONNECTING THE PNEUMATIC PEDAL (Fig. 7-N and Fig. 8) Insert the pneumatic pedal tube in the dedicated connector on the rear of the device (identified by the standardised icon). It is advisable to insert the pedal in a PVC bag (or similar) in order to keep it clean during the operation.

EN 8

6. DESCRIPTION OF THE DEVICE AND ITS CONTROLS

EN

THD REVOLUTION Front view - Display (Fig. 6) A) Brightness control B) Volume control C) Doppler probe connector D) Fibre-optic cable connector E) Display F) START button G) STOP button H) INFO button

Rear view (Fig.7) I) Power cable connector J) On/off switch K) Fuses L) Equipotential connector M) Identification plate N) Pneumatic pedal connector

DOPPLER PROBE (Fig.3) Probe body The electroacoustic probe is enclosed in the probe body. The outer casing consists of a body appropriately dimensioned to be inserted in the seat of the THD dearterializer. This body is made of medical-grade plastic and ensures excellent electrical insulation. Within this protection, the electrical circuits that connect the crystals to the cable are coated with a special insulating epoxy resin. Cable The cable is composed of two coaxial cables wrapped in an external braid and additional insulation. Connector The connector casing encloses four signal pins and an earth pin. FIBRE-OPTIC CABLE (Fig. 4) The fibre-optic cable is composed of: • A cylindrical connector for connection to THD REVOLUTION. • A 200cm-long fibre-optic cable inserted in a reinforced silicone sheath.

7. DIRECTIONS FOR USE WARNING: Before making THD REVOLUTION operational and preparing the patient for surgery, you must have correctly carried out all the operations described in Section 5 “Installation”. Make sure that the fibre-optic cable and the Doppler probe, if necessary NON DISPOSABLE, have been cleaned and sterilized before connecting them (see Section 8 for the sterilization information). Make the connections using an aseptic technique. Make sure that the THD REVOLUTION turns on and the screen shows the welcome message: “THD REVOLUTION Haemorrhoidal surgery without excision”, if not, do not start surgery. EN 9

Make sure that you have a backup probe available (refer to the section “CHARACTERISTICS” under “BACKUP DOPPLER probe”)

CONNECTING THE FIBRE-OPTIC CABLE (Fig. 9 and Fig. 10) Insert the connector (Fig. 4) in its outlet on THD REVOLUTION indicated by a dedicated icon (light). Connect the terminal to the handle of the THD dearterializer. WARNING: the fibre-optic cable connector is fitted with a sensor that detects the presence of the cable preventing the light source from coming on if the fibre-optic cable is not present (preventing the risk of being blinded by the light source). Do not aim the fibre-optic cable at the eyes! Risk of being blinded by the light! CONNECTING THE DOPPLER PROBE (Fig. 9 and Fig.10) 1. Turn on the device by setting the switch on the rear to position “1” (Fig. 11). 2. Check that the display on the front of the device comes on (Fig. 6-E). 3. Check functioning of the cooling fan inside the device. 4. After a few seconds, the following message appears on the display: THD REVOLUTION Haemorrhoidal surgery without excision For THD REVOLUTION to be used in modality as “Light Source”, please, proceed to section 13. 5. Insert the Doppler probe (Fig. 10) in its rectangular housing on the single-use THD dearterializer. 6. Insert the Doppler probe connector in its housing on the front of the device (Fig. 9). 7. After pressing START, The following message is shown on the display (*): Remaining operations: nn Transducer OK Press START when ready When you are ready to perform the operation, press START (►) again (Fig. 6-F). 8. After pressing START, the following message appears: TIME: 89:59 , the fibre-optic light source turns on, the sound source is activated and you can hear the classic “swish” of the Doppler. Check that the light in the THD dearterializer comes on. 9. Adjust the Doppler volume and the LED brightness using the dedicated knobs (Fig. 6). 10. An acoustic signal will warn you 5 minutes before the available time runs out and it will be repeated every 60 seconds. 11. When the time has run out, the Doppler and the light will go off and the following message will appear: End of operation Remove the transducer 12. It is advisable to turn off the device at the end of each procedure by setting the switch on the rear to position “0” (Fig. 11). Wait at least 30 seconds before turning the unit on again. 13. If used in modality “Light Source”, press INFO button ( ) 14. The choice “Light Source” will appear. 15. Press “START”, to select this modality. 16. Press START to turn on the LED (It turns on only if the fiber optic is plugged in), adjust light intensity by using the dedicated knobs (fig. 6). 17. Press STOP to turn off the LED. 18. Press STOP x 2 to exit the modality “Light Source” Should you encounter any problems, turn off the device and consult the TROUBLESHOOTING section in this manual. If the problems persist, contact the dealer/technical service centre. (*) If the following message is shown on the display: Limit of operations reached, replace the transducer. Replace the probe with a suitable one. EN 10

Make sure that the cables cannot get in the way or be crushed during the operation.

EN

The audio signal can be deactivated with the pedal (depressing it once - the letter M appears in the top right-hand corner of the display) or activated (depressing it another time); volume adjustment remains that set with the knob. To extend the life of the system, turn it off after each procedure. For the surgical operation procedures and use of the THD dearterializer, refer to the manual contained in the THD KIT package.

WARNING: do not remove the Doppler probe or the fibre-optic cable when the device is on. OSD (Display Menu) THD REVOLUTION provides some simple multi-language information to the user. Described below is how to obtain this information. To exit from any menu, press STOP(■). The buttons and their function: (►) START/CONFIRM, (■) STOP/EXIT, ( ) INFO/SCROLL DEVICE INFORMATION (before the probe is inserted) Press INFO and the following message will be shown on the display: Maintenance menu “Light Source” Pressing START (►) Select the visualized modality. In the following the menu maps Light Source> START- turn on the LED STOP - turn off the LED/exit System Information> Lamp hours:xx; Fan=Ok; Internal temp:xx,x°C;Sw.rev.n.m Language Selection> INFO button: shows available lagnuages START button: to select visualized language Transducer s/n> serial number of the inserted transducer Pressing STOP (■) the menu goes back to System information Pressing the button ( ) several times, other menus will alternately be displayed: “Light Source > System Information > Language selection > probe s/n” CHANGE LANGUAGE Press INFO ( ) until you find Select language, press START (►) to select the submenus, then find the desired language by pressing INFO ( ) and select the language by pressing START (►); from this moment on all the menus will be displayed in the language selected.

8. CLEANING AND STERILIZATION THD REVOLUTION

WARNING: Always disconnect the power cable before cleaning. THD REVOLUTION may never be cleaned by immersing it in water or a solution, disinfected in a steam autoclave or sterilized by gas, and never use cleaning or disinfection methods that might cause moisture to form in the device.

EN 11

Clean the device with a soft cloth or gauze soaked in an enzymatic substance (or another legally marketed product), EPA-registered disinfectant solution. Be careful not to let liquids penetrate the device during cleaning. Thoroughly dry with a soft, clean and dry cloth to remove any traces of moisture. Do not use abrasive materials to prevent damaging the surfaces. Do not use solvents. The pedal can be cleaned in the same way and does not need to be sterilized.

For cleaning and sterilization of the accessories, refer to the respective user manuals.

9. MAINTENANCE Device maintenance (except for the operations listed below) may only be carried out by THD S.p.A. The user may only carry out the following operations: • Replace the fuses WARNING: before proceeding with the operations listed below, check that the power cable is disconnected and that the on/off switch is in position “0”. REPLACING THE FUSES Open the fuse box next to the power outlet on the rear of the device (Fig. 11) prising in the cavity with a screw driver. Remove the fuses and replace them with new ones of the same type. If the problem persists, contact Technical Service.

WARNING: The device must periodically (at least once a year) be checked by the user to verify its electrical safety in accordance with EN 60601-1

10. TRANSPORT AND STORAGE The place where the device is stored must be dry, clean, well ventilated with a temperature between 0° and 40°C. Do not expose the device to direct sunlight, sudden temperature changes, excessive humidity. Storage at temperatures outside the range specified may cause device deterioration. Do not bend, twist or grip the fibre-optic cable and the Doppler probe cable with excessive force. Do not roll up these cables tighter than they were when packed in the cardboard box.

EN 12

If transporting the device to other sites, it is advisable to use the original packaging and make sure that the transport conditions are the same as those indicated for storage.

EN 11. DISPOSAL THD REVOLUTION does not contain hazardous materials as defined in the regulations in force. INFORMATION FOR USERS: in accordance with Art. 13 of Italian Legislative Decree 151 of 25 July 2005, "Implementation of Directives 2002/95/EC, 2002/96/EC and 2003/108/EC, regarding the reduction of hazardous substances in electrical and electronic equipment, as well as waste disposal”. The crossed out wheelie bin symbol on the device or its packaging indicates that the product must be collected separately from other waste at the end of its useful life. Separate collection of this device at the end of its life is organised and managed by the manufacturer. A user who wishes to dispose of the device must therefore contact the manufacturer and follow the system the latter has adopted to allow separate collection of the device that has come to the end of its life. Appropriate separate collection enabling the discarded device to be sent for recycling, treatment and environmentally compatible disposal helps prevent any negative effects on the environment and on health and encourages the re-use and/or recycling of the materials of which the device is made. Illegal disposal of the product by the holder will result in application of administrative sanctions according to the regulations in force.

12. SYMBOLS

Symbol

Meaning

Symbol

Meaning

Applied part type BF

Brightness control

Equipotential connection

Volume control

Pneumatic pedal connection

Doppler probe connector

Area potentially susceptible to electrostatic discharge

Fibre-optic cable connector

EN 13

13. WARRANTY CONDITIONS THD S.p.A. gives a 12-month warranty on all functioning, material or manufacturing defects of THD REVOLUTION and its accessories valid from the date of the purchase invoice. In the event of justified claims, THD S.p.A. or its authorised dealer shall repair or replace the product free of charge. No other claim of any kind will be acknowledged, in particular claims for compensation for damage. THD S.p.A. does not assume any responsibility for damage caused by unforeseen operations carried out by persons foreign to THD S.p.A. THD S.p.A. cannot be held responsible for damage, injury and the relative consequences deriving from: - Excessive wear - Use different from what is indicated in the instructions for use in this manual - Negligence or malice - Inobservance of the instructions for use, installation and maintenance - Anomalous chemical, electrical or electrolytic influences - Bad connections - Tampering The single-use devices (THD KIT-THD SLIDE) are not covered by this warranty. The warranty shall become invalid when the damages and their consequences are attributable to incorrect use, modifications to the product carried out by third parties not authorised by THD S.p.A. or use in conjunction with accessories different from those specifically designed for use with the device and indicated in this manual. The warranty shall be applied only upon presentation of the product together with a copy of the invoice or transport document. The date of purchase, the product reference and the serial number must clearly be shown on these documents (Fig. 12). Any operation on THD REVOLUTION and its accessories not described in this user manual shall be carried out by THD S.p.A. on pain of immediate forfeiture of the warranty.

14. TROUBLESHOOTING PROBLEM

The display does not turn on.

No sound or poorly audible (*).

EN 14

POSSIBLE CAUSE

SOLUTION

The power cable is not connected to the mains socket and/or the THD REVOLUTION connector.

Check that the plugs have fully been inserted at both ends.

The main switch is not set to ”I”.

Set it to on.

The protection fuse has burned.

Disconnect the power cable from the mains socket. Remove the fuse box and replace the fuse (see the section “Maintenance”).

The cable is damaged.

Replace the cable.

No voltage at the mains outlet.

Have the electric system checked by a technician.

The THD REVOLUTION switch is not set to on.

Set it to on.

The audio signal has been deactivated with the pedal.

Depress the pedal once or several times.

Volume too low.

Turn the volume knob clockwise to increase the sound level.

Doppler probe not properly connected.

Properly connect it (see the section “Installation”)

Doppler probe faulty.

Replace the Doppler probe.

PROBLEM No sound or poorly audible (*).

No light or light attenuation.

Overheating.

POSSIBLE CAUSE

SOLUTION

High-frequency devices (electric scalpels, mobile phones, X-ray units, etc.) in the vicinity are turned on.

Turn off the devices or take them away.

Insufficient LED brightness.

Increase the brightness by turning the corresponding knob clockwise.

Fibre-optic cable not properly connected.

Properly connect the cable.

Cable optical fibres broken or damaged.

Replace the cable.

LED light source not working.

Turn on the fibre-optic light source. If the problem persists, contact Technical Service.

Fuse burned.

Disconnect the power cable from the mains socket. Remove the fuse box and replace the fuse (see the section “Maintenance”).

The THD REVOLUTION switch is not set to on.

Set it to on.

Inadequate space for the air intake.

Check the position of the device.

Fan locked (message on display)

Contact Technical Service.

Fan clogged.

Disconnect the power cable from the mains socket and clean the fan.

EN

The device appears damaged. Any other problem. The operation carried out according to the instructions has not solved the problem.

Contact Technical Service.

(*) THD REVOLUTION is set up to mute the audio if it reaches annoying levels; if this occurs, wait until the audio is automatically restored (1-2 sec. - the letter C appears in the top right-hand corner of the display). If longer interruptions occur, check the electric system of the place of installation.

EN 15

ERROR CODES MESSAGE

DESCRIPTION

RESOLUTION

Error #1

The probe has been replaced after the first authentication

Use another Doppler probe

Error #2

Operation decrement failed

Error #3

The number of operations in the database does not correspond to the number in the probe

Error #4

The probe is not present in the database, the counter has been reset

Error #5

Probe protection failed

Error #6

Probe counter reset failed

Error #7

Code not active

Error #8

Probe CRC incorrect

Error #9

Probe operations run out

The probe has been used for the permitted number of treatments. Use a new probe

Error #10

Invalid probe code

Doppler probe not working Use a new Doppler probe

Error #11

DS2480 not detected

Use a new Doppler probe

The Doppler probe has been used improperly Use another Doppler probe

If the problem persists, contact Technical Service. Error #12

Doppler probe memory cable in short-circuit

Use a new Doppler probe If the problem persists, contact Technical Service.

For any further information on the contents of this manual or on device operation or safety, contact the manufacturer or your local dealer. THD S.p.A. is relieved of all responsibility for damage deriving from any use of the device different from what is described in this manual. Manufacturer: THD S.p.A Via Industria 1, 42015 Correggio (RE) ITALY Tel: +39 0522 634311 Fax: +39 0522 634371

EN 16

REF 370056 REV.H 12/06/2015