PULSON 200 User Manual V1.0

Pulson 200

TABLE OF CONTENTS 1 SAFETY ... 7 1.1 1.2 1.3 1.4

PURPOSE ... 7 SAFETY INSTRUCTIONS ... 7 MEDICAL DEVICES DIRECTIVE ... 9 LIABILITY ... 9

2 INSTALLATION... 11 2.1 2.2 2.3 2.4 2.5 2.6

RECEIPT ... 11 PLACING AND CONNECTION ... 11 PERFORMING THE FUNCTIONAL TEST ... 11 SETTING CONTRAST AND SELECTING LANGUAGE ... 11 TRANSPORT AND STORAGE... 12 RESELLING ... 12

3 DESCRIPTION OF THE EQUIPMENT ... 13 3.1 3.2 3.3 3.4

COMPONENTS OF PULSON 200 ... 14 DISPLAY ... 15 DISPLAY SYMBOLS ... 16 PARAMETER SYMBOLS ... 16

4 OPERATION... 17 4.1 4.2 4.3 4.4 4.5

THERAPY SELECTION... 17 SET AND START THERAPY ... 20 ULTRASOUND THERAPY ... 21 PROGRAMS ... 24 SYSTEM SETTINGS ... 26

5 INSPECTIONS AND MAINTENANCE ... 29 5.1 5.2

INSPECTIONS ... 29 MAINTENANCE ... 31

6 MALFUNCTIONS, SERVICE AND GUARANTEE ... 33 6.1 6.2 6.3 6.4

MALFUNCTIONS ... 33 SERVICE ... 34 GUARANTEE ... 34 TECHNICAL LIFE TIME ... 35

7 TECHNICAL INFORMATION ... 37 7.1 7.2 7.3 7.4 7.5 7.6

GENERAL... 37 ULTRASOUND THERAPY ... 37 ENVIRONMENTAL CONDITIONS... 38 TRANSPORT AND STORAGE... 38 STANDARD ACCESSORIES ... 39 OPTIONAL ACCESSORIES ... 39 5

Pulson 200 8 APPENDICES... 41 8.1 8.2 8.3

EMC DIRECTIVE... 41 TECHNICAL SAFETY INSPECTION ... 45 DISPOSAL ... 47

9 REFERENCE ... 49 9.1 9.2 9.3 9.4

TERMINOLOGY ... 49 LITERATURE... 49 FUNCTION OVERVIEW ... 51 INDEX ... 53

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Pulson 200

1

SAFETY

1.1

Purpose

The Pulson 200 is intended solely for medical applications. You can use the Pulson 200 for ultrasoundtherapy. The device is suited for continuous use.

1.2

Safety instructions

1.2.1

General • • • • • • • • • • • •

•

•

Only qualified people who are trained in the application of the therapies may use the appliance. Only a technician authorised by GymnaUniphy N.V. may open the equipment or the accessories. Follow the instructions and directions in these user instructions. Place the equipment on a horizontal and stable base. Keep the ventilation openings at the bottom and rear of the equipment free. Do not place any objects on the equipment. Do not place the equipment in the sun or above a heat source. Do not use the equipment in a damp area. Do not let any liquid flow into the equipment. Do not disinfect or sterilise the equipment. Clean the equipment with a dry or moistened cloth. See §5. Only treat patients with electrical implants (pacemaker) after obtaining medical advice. The 'Medical Devices Directive' from the European Commission (93/42/EEG) requires that safe devices are used. It is recommended to perform a yearly technical safety inspection. See §5.1.2. For optimum treatment, a patient investigation must first be performed. On the basis of the findings of the investigation, a treatment plan with objectives will be formulated. Follow the treatment plan during the therapy. This will limit possible risks, related to the treatment, to a minimum. Always keep these user instructions with the equipment.

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Pulson 200

1.2.2

Electrical safety • •

1.2.3

Prevention of explosion • •

1.2.4

Do not use the equipment in an area where combustible gases or vapours are present. Switch off the equipment when it is not used.

Electro Magnetic Compatibility •

•

•

1.2.5

Only use the equipment in an area with facilities that meet the applicable legal regulations. Connect the equipment to an outlet with a protective earth terminal. The outlet must meet the locally applicable requirements for medical areas.

Medical electrical equipment requires special precautions for Electro Magnetic Compatibility (EMC). Follow the instructions for the installation of the equipment. See §2. Do not use mobile telephones or other radio, shortwave, or microwave equipment in the vicinity of the equipment. This kind of equipment can cause disturbances. Only use the accompanying accessories that are supplied by GymnaUniphy. See §7.6. Other accessories can lead to an increased emission or a reduced immunity.

Ultrasound therapy • •

•

•

Move the US head evenly over the skin during the treatment. This prevents internal burns. The US treatment heads are exchangeable. The device detects the characteristics and supplies the right power at the right frequency. Handle the US heads carefully. With rough handling, the characteristics can change. Test the US head if it falls on the ground or knocks against something. See §5.1.1. Check the US head at least once a month. During the check, look for dents, cracks and other damage that could allow liquids to ingress. Check whether the insulation of the cable is still intact. Check whether all pins are present and straight in the connectors. Replace the US head if the head, the cable or the connector is damaged. See §5.1.

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Pulson 200

1.3

Medical Devices Directive

The device complies with the essential requirements of the Medical Device Directive of the European Committee (93/42/EEC) as most recently changed.

1.4

Liability

The manufacturer cannot be held liable for injury to the therapist, the patient or third parties, or for damage to or by the equipment used, if for example: • an incorrect diagnosis is made; • the equipment or the accessories are used incorrectly; • the user instructions are wrongly interpreted or ignored; • the equipment is badly maintained; • maintenance or repairs are performed by people or organisations that are not authorised to do so by GymnaUniphy. Neither the manufacturer nor the local GymnaUniphy dealer can be held liable, in any way whatsoever, for the transfer of infections by accessories.

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Pulson 200

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Pulson 200

2

INSTALLATION

2.1

Receipt

1. Check whether the equipment has been damaged during transport. 2. Check whether the accessories are intact and complete. See §7.6. • Inform your supplier of any damage or defects by no later than within 3 working days after receipt. Report the damage by telephone, fax, email or letter. • Do not use the equipment if it is damaged or defective.

2.2

Placing and connection

1. Place the equipment on a horizontal and stable base. • Keep the ventilation openings at the bottom and rear of the equipment free. • Do not place the equipment in the sun or above a heat source. • Do not use the equipment in a wet area. 2. Check whether the mains voltage that is stated on the rear of the equipment corresponds with the voltage of your mains supply. The equipment is suited for a nominal mains voltage from 100 V to 240 VAC / 50-60 Hz. 3. Connect the device to an outlet with protective earth terminal.

2.3

Performing the functional test

1. Switch the equipment on with the switch at the rear of the equipment. 2. When the equipment is switched on, it automatically performs a test.

2.4 1. Press 2. Press

Setting contrast and selecting language for 5 seconds The System setting menu appears. See §4.5. next to Contrast, 1st key from the top.

3. If necessary, change the contrast with 4. Press

.

next to Language.

5. If necessary, change the language with 6. Press

and

to return to the start menu.

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and

.

Pulson 200

2.5

Transport and storage

Take account of the following matters if the equipment has to be transported or stored: • Transport or store the equipment in the original packaging. • The maximum period for transport or storage is: 15 weeks. • Temperature: -20 °C to +60 °C. • Relative humidity: 10% to 100%. • Atmospheric pressure: 200 hPa to 1060 hPa.

2.6

Reselling

This medical equipment must be traceable. The equipment, the US head and some other accessories have a unique serial number. Provide the dealer with the name and address of the new owner.

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Pulson 200

3

DESCRIPTION OF THE EQUIPMENT 1

2

3 4

1. Pulson 200. See §3.1. 2. Power cord 3. Contact gel 4. US head

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Pulson 200

3.1

Components of Pulson 200

1 2 13

3 4

12 11 10

!

5

6

7

8

14 15 16 17 18 19

20

9

1. Display. See §3.2.

14.Connector for US head

2. Ultrasound therapy

15.Indication: Floating patient circuit

3. Memory 4. Start menu

16.On/off switch

5. Stop

17.Connection to mains supply

6. Pause

18.Type plate

7. Intensity

19.Ventilation opening

8. Return to previous menu

20.Fuse holder

9. Enter 10.Indication: Read manual 11.Down 12.Up 13.Select parameter or menu

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Pulson 200

3.2

Display

1

2

3

4

5

US+Conv. TENS

8

9 10 11 12

15:00

Pulse time

34 40

s

red+ 0

Pulse form

CV

Min. frequency

80 Hz

Max. frequency 100 Hz . set00

Sweep mode

0.0

Treatment time

15:00

Perceptibe, comfortable

7

2. Ultrasound therapy

8. Screen for channel A. See §4.3.2.

3. Type of US head

9. Remaining treatment time

4. Title of the screen

10.Îset

5. Program number

11.Ppk

6. Parameters with selection knobs

12.Contact of the US head

1. Channel

7. Explanation or recommendation

15

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Pulson 200

3.3

Display symbols Ultrasound therapy

A

3.4 1

2

3

Treatment time 0:00 Treatment completed

Channel A

Parameter symbols

10ms

10% US duty cycle 10%

set

Set US intensity

10ms

20% US duty cycle 20%

Ppk

Peak US output power

10ms

30% US duty cycle 30%

4

40% US duty cycle 40%

5

50% US duty cycle 50%

10ms

10ms

Unit of the set US

W /cm2 intensity

100% US duty cycle 100%

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Pulson 200

4

OPERATION

4.1

Therapy selection

You can select a therapy in different ways, with the therapy key or with the parameters in the Start menu: • Therapy key: Quickly select a therapy with the therapy key §4.1.1.

. See

• Objectives: Select a therapy on the basis of an objective. See §4.1.2. • Indication list: Select a therapy on the basis of a medical indication. See §4.1.3. • Program number: Select a certain program number or a program number that you previously saved. See §4.1.4. • Diagnostic programs: Perform a diagnosis. See §4.1.5. • Contra-indications: Display an overview with contra-indications for the ultrasound therapy. See §4.1.6. Besides this, you can change the system settings. See §4.5.

4.1.1

Therapy key

Press : Ultrasound therapy. The Ultrasound screen appears.

4.1.2 1. Press

Therapy selection via objectives to go to the start menu.

2. Select Objectives. 3. Select the desired treatment with .

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Pulson 200

4.1.3

Therapy selection via indication list

1. Press

to go to the start menu.

2. Select Indication list. 3. Go to the following indications with or . See §9.3.4. 4. Select the desired indication with . • US: Ultrasound therapy

4.1.4

Program number selection

1. Press

to go to the start menu.

2. Select Program number. 3. Select the desired program with or . See §9.3. 4. Press

.

See §4.4.

4.1.5

Diagnostic program selection

With the diagnostic programs, you can search for stress fractures. 1. Press

to go to the start menu.

2. Select Diagnostic programs. 3. Select Stress fracture search with .

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Pulson 200

4.1.6 1. Press

Contra indication selection to go to the start menu.

2. Select Contra indications.

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Pulson 200

4.2

Set and start therapy

1. Press

to go to the start menu.

2. Select the desired menu with until the treatment appears. 3. Select the desired parameters with . You can only change the outlined parameters. Set the Treatment time as follows: Press once on to set the minutes, press twice on to set the seconds. 4. Change the value of the parameter with and . The setting range of the parameter is shown at the bottom of the screen. You can change the parameter as long as the parameter has a black background. 5. Rotate intensity knob to start the treatment and to set the desired intensity. The set intensity is displayed in the screen.

4.2.1

Opening the intensity screen

1. Set the treatment. See §4.2. 2. Rotate intensity knob to start the treatment. 3. Press . The intensity screen appears. 4. Press menu.

4.2.2

to return to the setting

Temporary interruption of treatment

1. Press during the treatment. The treatment time of the selected channel is stopped. Pause appears on the screen. The parameter settings are retained. 2. Press on again to restart the treatment. The intensity now increases gradually to the set level and the treatment time continues again.

4.2.3

Immediately stop treatment

1. Press . All active treatments are stopped immediately. Stop appears on the screen. The parameter settings are retained. 2. Set the intensity of the channel again to continue the treatment. 20

Pulson 200

4.3

Ultrasound therapy

4.3.1

Performing ultrasound therapy Move the US head evenly over the skin during the treatment. This prevents internal burns.

1. Plug the connector of the US head into the connector of the Pulson 200. 2. Select the desired ultrasound therapy. With some treatments, the parameter Head placement refers to the number in the placing diagrams. 3. Apply contact gel to the skin to be treated and to the US head. 4. Place the head on the skin. 5. Rotate intensity knob to start the ultrasound therapy. 6. Move the US head evenly over the skin during the treatment. This prevents internal burns. 7. Check the patient's reaction and the effect of the treatment. Repeat this check regularly during the treatment. 8. The equipment stops the treatment and indicates that the treatment is completed.

4.3.2

Read-out values

1. Channel

1

2. Ultrasound therapy

2

3

3. Type of US head 4. Remaining treatment time

4 5 6 7

5. Îset 6. Ppk 7. Contact of the US head

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Pulson 200 Contact of US head The contact of the US head with the skin: •

: Bad contact, US head switched off (0 W).

•

: Bad contact.

•

: Sufficient contact.

•

: Good contact.

•

: Very good contact

Test the US head if its conduction is bad. See §5.1.1.

Îset (W/cm2) The power (W) of the US head per cm². Ppk (W) The peak power of the US head (Îset * ERA). The peak power delivered therefore depends on the size of the US head and the contact with the skin. This value is 0.0 W if the contact with the skin is bad. In this case, the ultrasound treatment of the equipment is stopped to prevent overheating of the transducer.

4.3.3

Parameters

Treatment time (mm:ss) The duration of the treatment. Duty cycle (10, 20, 30, 50%, continuous) Ratio of the pulse duration to the period duration. • Continuous: Continuous ultrasound (100%). • 10, 20, 30, 50%: Pulsating ultrasound. Select a high duty cycle for an intensive treatment. Select a low duty cycle for a mild treatment. ERA (cm2) The effective radiating area expressed in cm² of the treatment head connected. This area equals the cross-sectional area of the beam at the treatment surface. The ERA depends on the frequency. This parameter remains empty if no US head is connected. Head placement Instructions for placing the US head. Consult the placement diagrams.

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Pulson 200 US frequency (MHz) The frequency of the US head. The absorption at a US frequency of 3 MHz is three times higher and the penetration depth is three times less than at a US frequency of 1 MHz. Use 3 MHz for superficial tissue and 1 MHz for deeper tissue.

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