BTL BTL-07p User manual

operating manual

user’s guide

v2.10z6BJ24/03/2004EN

BTL – 07p operating manual & user's guide

I. DIRECTIONS FOR USE................................................................................................................................... 4

Outer appearance 4 Controls and dipslays 4 Connection to the mains 5 Choosing the ultrasound frequency 5 Choosing and connecting emitter head 5 Choosing PPR (pulse-to-period ratio) 5 Choosing pulse frequency 5 Choosing intensity of acoustic output 5 Time setting 6 Ultrasound generation 6 Indication of stationary waves 6 Interrupting the therapy 6 Selecting the program 6 Saving personalised programs 6 Combined ultrasound/electrotherapy 6 Connecting the units 6 Starting the combined therapy 7 Ending the combined therapy 7 Summary of directions for use 7 Safety instructions 7

Useful addresses ...................................................................................................................................8

Warranty..................................................................................................................................................8

Maintenance and transport 8 Troubleshooting: 8 Technical specifications of probe 9 Technical specifications of unit 9 Pulse width 10

II. USER'S GUIDE .......................................................................................................................................... 11

Mechanism of action 11 Methods of application 12 Ultrasound frequency 13 Modes of operation 13 Emitter head size 13 Application time 13 Intensity 13 Procedure frequency 13 Total number of treatments 13 Specific contraindications of ultrasonic therapy 14 Procedure 15 A therapeutic example 15 Combined therapy 16 Ultrasound and low frequency currents 16 Mechanism of action 16 Application time 16 Intensity 16 Total number of procedures 16 Frequency of procedures 16 Procedure Prescription 16 A therapeutic example 17 Ultrasound + amplitude modulated mid-frequency currents 17 Mechanism of action 17 Application time 17 Number of procedures 17 Procedure frequency 17 Procedure prescription 17 A therapeutic example 17

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BTL – 07p operating manual & user's guide

Ultrasound + TENS (transcutaneous electrostimulation) 18 Mechanism of action 18 Application time 18 Intensity 18 Total number of treatments 18 Frequency of treatment 18 Procedure prescription 18 A therapeutic example 18

III. LIST OF PROGRAM NUMBERS FOR ULTRASOUND THERAPY ........................................................... 19

IV. LIST OF PROGRAM NUMBERS FOR COMBINED ULTRASOUND THERAPY/ELECTROTHERAPY.... 25

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BTL – 07p operating manual & user's guide

I. DIRECTIONS FOR USE

FRONT PANEL OF BTL-07p

Outer appearance

Front panel features: pilot-lights, displays, push-buttons, input for emitter head, input for BTL-06, input for electrical cable, mains switch, fuses, serial and model number are located on the rear panel.

Controls and dipslays

1) Display indicating power absorbed by patient (in kilojoules).

2) Select button

3) Time display to show pre-set and remaining therapy time (in minutes).

4) Push-button to set therapy time (in minutes).

5) LED diode indicating use of set parameters.

6) Display of pre-set acoustic output (indicated by two pilot lights).

7) Push-button to set acoustic output.

8) Push-button to change indication of acoustic output.

9) Duty Cycle push-button.

10) Column lights indicating contact of emitter head with skin.

11) Small ultrasound emitter head connector.

12) Signal lights:

• Ready - Emitter heads connected; intensity/therapy time is set.

• Error - Light signal a hardware defect indicating.

• Power - Light signal indicating the unit is on.

13) LED diodes. Indicate pre-set frequency.

14) LED diodes. Indicate pre-set pulse frequency.

15) Push-button to set 1 MHz/3 MHz frequency.

16) Push-button to set 50 Hz/100 Hz pulse frequency.

17) LED diode. Indicates PPR.

18) START/PAUSE push-button. Starts, ends and interrupts therapy.

19) LED diodes. Indicate 1 cm

or 4 cm

emitter head sizes.

20) Ultrasound emitter head connector.

21) Electrotherapy unit connector.

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BTL – 07p operating manual & user's guide

Connection to the mains

Read the "Safety Instructions" before using instrument!

Make sure that the mains switch is at "0". Connect mains cable to the connector on the rear panel with mains 230 V/50 Hz. Switch the main switch to "1". The program number, the preset treatment time, and the ultrasound frequency are lit up on the display. Choose the irradiation surface area and the emitter head (1 cm

or 4 cm

). Connect the emitter head with emitter head connector on the front panel. Never change emitter heads during ultrasound generation. Change emitter heads only if the instrument is switched off with the START/PAUSE button (17). Use RESET button if you begin therapy with another patient.

Choosing the ultrasound frequency

Use the FREQUENCY push-button (15) to choose the 1 MHz or 3 MHz frequency. The green diodes (13), situated to the left of the FREQUENCY button, indicate which of the two frequencies is activated. Both frequencies can be applied with either emitter head sizes. Choose a 1 MHz frequency if you wish to therapeutically affect deep tissues and a 3 MHz frequency for superficial tissues.

Choosing and connecting emitter head

Two emitter heads of either 1 cm Connect the emitter head to the Connector (11, 21). Connect the 1 cm

4 cm

head to Connector (21). The LED diode (19) indicates which emitter head is in use. Both emitter heads can

or 4 cm

can be used with the BTL-07p.

emitter head to Connector (11) and the

be used for either continuous or pulse modes and for both frequencies. The emitter head must be connected before intensity of acoustic output is set. The therapy cannot start without connecting and identifying the emitter head. The red diode on the emitter head indicates insufficient contact between the emitter head and the tissue. If contact is insufficient, the control light lights up red. The countdown on the TIME display (3) stops. Power absorption (indicated by the light blinking) stops. Therapy is interrupted until contact is restored. If there is proper contact, the control signal on the emitter head will light up green.

Choosing PPR (pulse-to-period ratio)

Different pulse-to-period ratios are related to different ultrasound thermic effects. Continuous ultrasound deeply heats tissues. A 1:2 or 1:4 PPR ultrasound only has a moderate thermic effect and 1:8 or 1:16 PPR ultrasound has an athermic. Use the DUTY CYCLE push-button (9) to set the PPR. The activated PPR is indicated by the green diode (17).

Choosing pulse frequency

The pulse ultrasound (1:2 - 1:16 PPR) allows the user to choose one of the pulse frequencies and the time duration. The BTL-07p uses 50 Hz and 100 Hz pulse frequencies. Press the PULSE FREQUENCY button (16) to switch between the two frequencies. The activated pulse frequency is indicated by the diode next to the PULSE FREQUENCY button (14). Impulse and pause duration of both frequencies are specified in the following tables.

Frequency 50 Hz, period duration 20ms Frequency 100 Hz, period duration 10ms Duty cycle Impulse

duration

Pause duration

Duty cycle Impulse

duration

Pause

duration 1: 2 10 ms 10 ms 1: 2 5 ms 5 ms 1: 4 5 ms 15 ms 1: 4 2.5 ms 7.5 ms 1: 8 2.5 ms 17.5 ms 1: 8 1.25 ms 8.75 ms 1: 16 1.25 ms 18.75 ms 1: 16 0.625 ms 9.375 ms

Choosing intensity of acoustic output

Press up/down arrow push-buttons (7) to set intensity. Continuous mode employs intensities up to 2 W/cm mode up to 3 W/cm

(in steps of 0.1 W/cm

). Pressing down the up/down push-button will increase or decrease

, pulse

intensity.

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BTL – 07p operating manual & user's guide

Time setting

The therapy time is shown on the TIME display (3). Press the up/down arrow push-buttons to increase or decrease time (4). The time is adjustable in steps of 0.5 minute up to 5 minutes and in steps of 1 minute up to 25 minutes. The maximum application time is 25 minutes. Hold the up/down push-button pressed to increase or decrease time.

Ultrasound generation

Generation of ultrasound begins after the following operations have taken place: Connect an emitter head to the instrument. Set intensity and time. READY control light should light up. If it does not, check the emitter head (19) connection and the head type (5). Try the other emitter head (8). Press START/PAUSE push-button (18). The set time must not be 0. The time display starts to count/down the pre-set time. If there is sufficient contact between the emitter head and the skin, the “Program” display will stop showing the program number and will start to count the amount of absorbed energy. The lowest green light in the CONTACT row will light up (10) and the light in the TIME and INTENSITY decimal boxes will start to blink. The columnar graph (10) and the emitter head control light both monitor the quality of contact during application. If contact is insufficient, diodes light up red. If this happens, moisten the skin with more ultrasound gel. A cold emitter head can also cause insufficient contact. In this case set the intensity to 0.1 W/cm

and generate ultrasound for approximately 1 minute to warm up the head. Then set the intensity. If there is insufficient contact between the head and the patient, the unit stops. If there is proper contact, the therapy continued. All parameters can be changed at any time.

Indication of stationary waves

Any ultrasound application to a bone or bony area situated just under the skin (condyles, epicondyles, ankles) may, if the emitter head is not moved sufficiently, result in interference between a reflected wave and an arising wave arising (stationary wave). Consequently, there are "peaks of intensity". A peak of intensity is an area, which is exposed to intensity higher than the preset intensity level. There is an increased local temperature in these areas. BTL-07p emitter heads have a very low BNR. Further more, the BTL-07p features an optic indicator to signal stationary waves, placed on the Bar-graph (10) (the orange LED diode). Respond to this signal by immediately removing the emitter head from the application site in order to eliminate any risk of soft tissue damage.

Interrupting the therapy

Pressing the START/PAUSE push-button (18) immediately interrupts the therapy. The time countdown stops and the pre-set intensity level, as well as the amount of absorbed energy, do not change. To continue therapy, press the START/PAUSE push-button again. To start a new treatment, set the time and start the ultrasound generation.

Selecting the program

The unit has pre-set programs for ultrasound and combined ultrasound/electrotherapy. The list of programs and procedures can be found in the user’s guide. Press button (2) to select the program or diagnosis. Any parameters can be changed before starting the application. Press the START/PAUSE button (18) to start the therapy.

Saving personalised programs

The BTL-07p enables you to save your own programs, which can be stored under codes 80-99. Set all the parameters. Press and hold the START/PAUSE button. After 2 seconds the bar-graph (10) blinks and there is an acoustic signal. Programs are stored when the unit is turned off.

Combined ultrasound/electrotherapy

The BTL-07p allows the user to apply ultrasound and electrotherapy at the same time. The ultrasound instrument can be connected to the BTL-06 electrotherapy unit. Do not connect the BTL-07p to electrotherapy units manufactured by other companies.

Connecting the units

Place the BTL-06 on the ultrasound BTL-07p. For combined therapy, the units are connected with a special cable. Plug the cable connector of an ultrasound emitter head into the outlet on the front panel (21). Insert the cable for combined therapy into the electrotherapy unit outlet (channel B for voltage mode). Insert the red banana plug into the BTL-07p outlet (20). Connect the electrode to the green banana plug. The ultrasound emitter head then serves as the anode (+) and the electrode as the cathode (-).

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BTL – 07p operating manual & user's guide

Starting the combined therapy

Set the instruments after they are connected. Set all needed parameters on the BTL 07p and press the START/PAUSE button (17). Press the STOP button (V/mA) (18) to set the voltage (the V control light is on). Choose the program and set the therapy time. Apply the electrode and the emitter head to the treatment area. The moment the emitter head touches the skin, the ultrasound will start and the time will begin to count down. Press the button (19) on the electrotherapy unit to set the voltage and start the combined therapy. Caution: Keep the ultrasound emitter head on the treated area during the therapy!

Ending the combined therapy

After the pre-set time has elapsed and the START/PAUSE button (17) on the BTL-07p has been pressed, the combined therapy stops. If there is a need to stop or interrupt the application before the pre-set time elapses, press the button (18) on the BTL-06 before removing the emitter head or the electrode from the skin.

Summary of directions for use

1. Connect the instrument to the mains.

2. Switch the instrument to "1".

3. Connect an emitter head to the instrument.

4. Choose the required program.

5. Check if the READY control light is flashing. If it is not, the emitter head is probably not connected.

6. Press the START/PAUSE push-button (17) to start application.

7. Press the START/PAUSE push-button (17) to interrupt therapy.

8. Therapy ends automatically when the pre-set time has elapsed.

Safety instructions

The BTL-07p ultrasonic therapy instrument is constructed with maximum regard for the safety of the patient and therapist. However, it is absolutely essential to strictly follow the safety instructions below:

1. Read the operation manual carefully before you use the instrument for the first time.

2. Make sure that the parameters of the mains correspond to those of the instrument.

3. The mains must be installed and correspond to valid norms. Call a qualified electrician if in doubt.

4. If the instrument is exposed to a sudden temperature charge, allow at least 1 hour for the temperature of the

instrument to equalize before turning it on.

5. Stop the therapy immediately if the instrument shows any signs of malfunction. If the instrument does not

turn on when activated, call or fax BTL’s Service Department. Do not attempt to repair the instrument! Removing the instrument housing will invalidate the service warranty.

6. Do not touch the metallic parts of the emitter head during therapy.

7. Make sure that all set parameters correspond to the desired parameters.

8. Do not cover the vents. Do not place the instrument on a soft surface that would prevent air from circulating

beneath it.

9. Never use the connectors for anything else but the electrotherapeutic instrument and the emitter head.

The user should not use the instrument, if it does not work as described in this manual. Contact your BTL service technician. The user is responsible for all damages resulting from using such an instrument. All materials that come in contact with the patient (gel, emitter head cleaners, etc.) comply with ISO 10993-1, ISO 10993-3 and ISO 10993-5 standards on hypersensitivity, toxicity and carcinogenicity. The user is responsible for use of all materials and parts not supplied by BTL.

WARNING!

These symbols mean that the electric voltage and current flowing through the input may exceed safe levels. BTL-07p has a BF safety level and floating attached parts. Never use the instrument in a manner other than that described in this operation manual!

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BTL – 07p operating manual & user's guide

Useful addresses

The product is manufactured in accordance with the EU Medical Devices Directive by :

BTL Industries Ltd.

Suite 401 Albany House 324-326 Regents Street London, W1B 3BL United Kingdom E-mail: sales@btlnet.com

http://www.btlnet.com

For service, please contact service department at service@btlnet.com

Warranty

The Manufacturer of this product warrants the product to be free from defects in workmanship and material for a period of twelve months after the date of shipment from the factory. This warranty excludes any disposable items and accessories, including, but not limited to cables or leads, power cords and electrodes. The manufacturer agrees to correct such defects without charge, or at its option to replace the item with a comparable model. To register and be eligible for warranty service, you must send or fax the fully completed warranty registration form within 30 days of installation. All costs of shipment are the responsibility of the purchaser. Damage to any part such as by accident or misuse or improper installation or by use of any accessories or abrasive material not produced by the Manufacturer is not covered by this warranty. Because of varying climatic conditions, this warranty does not cover any changes in finish, including rusting, pitting, corrosion, tarnishing or peeling. Servicing performed by unauthorized persons render this warranty invalid. There is no other express warranty. The Manufacturer hereby disclaims any and all warranties, including but not limited to, those of merchantability and fitness for a particular purpose to the extent permitted by law. The duration of any implied warranty which cannot be disclaimed is limited to the time period as specified in the express warranty. The Manufacturer shall not be liable for incidental, consequential, or special damages arising out of, or in connection with product use or performance except as may be otherwise accorded by law.

This warranty may differ from the warranty terms and conditions provided by your supplier and by applicable laws in your country.

Maintenance and transport

The unit can be cleaned with a damp cloth. Do not use alcohol-based solutions. Transport the instrument in its original packaging. Remove the power cable and emitter heads. Avoid rough handling. Fuses are located on the rear panel in black round cases. Make sure that the power switch is in position “0”. Unplug the mains cable from the instrument and from the mains plug. Use an appropriate screwdriver to rotate the inner segment of the fuse case counter-clockwise to remove and replace the fuse. Use only those fuses specified on the label below the fuse cases. Only qualified persons should replace fuses. If the unit no longer works and you plan to throw it out, please return it to the manufacturer so it can disposed of safely, or take it to a specialized disposal company.

Troubleshooting:

Problem No power or light displayed Check if the mains cable is plugged to the mains and the unit. Check

Therapy does not begin Check if the READY control light is blinking and set the therapy time.

The emitter head is plugged in but the LED diode does not flash Check if the connector is properly connected. Plug the small emitter

Signal lights are non-functional, Er is displayed Contact your service technician.

CONTACT signal lights up red Skin is too dry. during application Insufficient body contact.

Solution

the fuse.

Make sure that you are using the emitter head shown on the display.

head in the upper and the large emitter head in the lower connector. If the heads are connected and the control light does not flash contact your service technician.

Wrong emitter head size. Remember to use the larger emitter head for small, uneven surfaces.

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BTL – 07p operating manual & user's guide

If this signal persists, try to calibrate the emitter head. The 07p calibration procedure should be done as follows:

• Prepare yourself some water container for app. 0.5 liter (water temperature should be around 30 °C) with a sponge (or some swab or cotton wool) at the bottom.

• Connect your emitter head to proper connector.

• Turn on the device and choose the emitter heads type, by

pressing appropriately button, you are going to calibrate.

• Start generating ultrasound for app. 2 min. at a 2 W intensity, PIP=1:1. Use both frequencies one after another.

• Stop the therapy (if it is running).

• Put emitter head into the water – app. 1cm under the water level

(1cm from the metal top of the head).

• Press the “Pulse frequency” button down and hold it there. The bar graph LEDs will be running up and down. After certain time you will hear a sound. Release the “Pulse frequency” button and remain the emitter head under the water until the bar graph LEDs will stop running.

• Take the emitter head out of the water and dry it with some cloth.

• Leave the emitter in the air.

• Press the “Frequency” button down and hold it there. The bar

graph LEDs will be running up and down. After certain time you will hear a sound. Release the “Frequency” button and wait until the bar graph LEDs will stop running.

- the calibration is done.

You might control it after:

- begin generating and leave the emitter head in the air (the red LED

should be on), put the emitter head into the water (the green LED should be on immediately).

READY signal does not light up Set application time and/or acoustic output.

Emitter head is not connected.

Technical specifications of probe

Effective radiation area (ERA): 1 cm

Accuracy of radiation area:

or 4 cm2 (depends on size of head)

± 20 %

Radiation frequency: 1 MHz or 3 MHz Accuracy of radiation area:

± 10 kHz Insulation: IP 67 Weight: 0,3 kg approx. BNR: < 5.0 Contact indication: green/red indicator on probe

Technical specifications of unit

Maximum acoustic power:

continual operation: pulse operation:

2 W/cm

3 W/cm

± 20 %

± 20 % duty cycle: 1:1, 1:2, 1:4, 1:8, 1:16 for frequency 50 Hz or 100 Hz accuracy of duty cycle: accuracy of frequency:

Therapy time adjustment:

± 20 % ± 20 %

in the range of 0 - 25 min. (in steps of 0.5 min. up to 10 min., and 1 steps from 10 min. up )

Mains voltage: 198 V to 252 V (complies with EN)

50 Hz ± 10 % Energy input: 50 VA Max Working conditions:

room temperature

+ 15 °C to + 40 °C

relative humidity: 0 % to 80 % atmospheric pressure: 700 hPa to 1060 hPa

Storage conditions:

room temperature:

- 10 °C to + 55 °C

relative humidity: 0 % to 85 %

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