DolorClast Radial Instructions for Use Rev A PDF download

INSTRUCTIONS FOR USE

DOLORCLAST ®

Radial

DOLORCLAST® RADIAL ENGLISH ... 3

2

ENGLISH

CONTENTS PLEASE READ THIS FIRST!...4

5.1. ANALGESIC MODES�� 21

ABOUT THIS MANUAL ...4

5.2. RAMP-UP MODES�� 22

PRODUCT DESCRIPTION ...4

5.3. BURST MODES�� 23

INDICATIONS FOR USE ...4

6. CLEANING AND DISINFECTING�� 25

INTENDED USER...4

6.1. HANDPIECE�� 25

CONTRAINDICATIONS ...5

6.2. APPLICATORS�� 25

POTENTIAL COMPLICATIONS...5

6.3. CONSOLE�� 25

PRECAUTION...5

7. MAINTENANCE�� 26

1. INSTALLATION�� 6

7.1. HANDPIECE �� 26

1.1. COMPONENTS�� 6

7.2. CONSOLE�� 31

1.2. INSTALLING THE CONSOLE�� 8

8. TROUBLESHOOTING�� 31

1.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR�� 9 1.4. CONNECTING THE HANDPIECE TO THE CONSOLE�� 9 1.5. CONNECTING THE POWER CORD�� 9

2. GETTING STARTED�� 10 2.1. STARTING THE DEVICE�� 10 2.2. INTERFACES�� 10 2.3. SOFTWARE AND HANDPIECE INFORMATION (NUMBERS OF USE)�� 12 2.4. SETTING THE LANGUAGE�� 12 2.5. STOPPING THE DEVICE�� 13

3. TREATMENT�� 14

9. COMPATIBILITY WITH DOLORCLAST® PRODUCT RANGE�� 32 10. PRODUCT STORAGE AND SHIPPING�� 32 11. ELECTROMAGNETIC COMPATIBILITY�� 32 12. PRODUCT DISPOSAL�� 36 13. EMS TECHNICAL SUPPORT�� 36 14. WARRANTY�� 36 15. TECHNICAL DESCRIPTION�� 37 16. SYMBOLS�� 39 17. APPENDIX�� 41

3.1. PREPARING THE PATIENT�� 14 3.2. TREATMENT SETTINGS (CHANGING APPLICATOR, PRESSURE, FREQUENCY, PULSES, ENERGY DENSITY)14 3.3. PERFORMING TREATMENT�� 17

4. PRESET PROTOCOLS�� 19 4.1. DESCRIPTION OF PRESET PROTOCOLS�� 19 4.2. SELECTING THE PRESET PROTOCOLS�� 19 4.3. ADJUSTING THE PRESET PROTOCOLS�� 19 4.4. SAVING ADJUSTED PRESET PROTOCOLS� 20

5. SPECIAL MODES�� 21

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Please read this first! We would be pleased to answer your questions and we welcome your suggestions. We do, of course, provide support in case of technical problems. Please contact your local EMS service center. We wish you lots of success! About this Manual Please note that the English version of this manual is the source from which all translations are derived. In case of any discrepancy, the binding version is the English text. These operating instructions are to ensure the correct installation and use of this product. Always keep these instructions close at hand. Please read these operating instructions carefully as they explain important details and procedures. Please pay special attention to the safety precautions.

Product description The DOLORCLAST® Radial system generates clinically therapeutic pressure pulses. The pressure pulses are generated ballistically in the handpiece from a supply of compressed air from integrated compressors in the console. The pressure pulses are delivered to the patient via the handpiece applicator. The device allows control of the pressure from 1-4bar; frequency up to 25Hz and the number of pulses for the treatment. Please note that this device can only be used on the U.S. market. Indications for Use The DolorClast Radial is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue. Intended User

Any serious incident that has occurred in relation to the product should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

The device must be used by qualified health experts (such as doctors and physiotherapists) in hospitals, clinics, medical universities and physical therapists’ offices. They must use this device by fully complying with their respective country’s regulations, accident prevention measures, and strictly follow these instructions for use.

To prevent injury to people and damage to property, please follow the corresponding directives.

No specific training other than initial professional training is required to use this medical device.

They are marked as indicated: Warning: A warning indicates a situation which, if not avoided, could result in death or serious injury. Precaution: A precaution indicates a situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment of other property. Note: Useful additional information and hints.

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The practitioner is responsible for performing the clinical treatments and for any dangers that may arise due to a lack of skill and/or training.

Contraindications

Precautions

Do not use this device under these conditions: •

Treatment over air-filled tissue (lung, gut),

•

Treatment of pre-ruptured tendons,

•

Treatment of pregnant women,

•

Treatment of patients with blood-clotting disorders (including local thrombosis),

•

Treatment of patients treated with oral anticoagulants,

•

Treatment of tissue with local tumors or local bacterial and/or viral infections,

•

Treatment of patients treated with cortisone (within the 6-week period following the last local cortisone injection),

•

Do not apply pulses to any regions near large nerves, vessels, the spinal column or head,

•

NEVER use this device on the unconscious, or anyone who cannot give verbal consent or warnings about pain.

Warnings Before using this product, please carefully read, understand, and follow the recommendations in the instruction manual. Failure to observe the operating instructions may result in the patient or user suffering serious injury or the product being damaged. This product may only be applied for its intended use by qualified personnel and for the applications described in this manual. If the product is used in combination with other instruments, please refer to their instruction manual. No modification shall be made on the product. Unauthorized modification may result in serious injury to patient or user, and damage of the product. This device should not be used over swollen of inflamed areas or skin eruptions.

ALWAYS move the handpiece over the treatment zone. This enables visual feedback of potential side effects such as redness, petechias, or bruising. Continuous repetitive pulses concentrated in one spot may lead to bruising. Caution should be used over joints or bony prominences such as vertebrae. Use of this device may be painful or cause bruising. In case of extended use of more than 6 hours, it is recommended that the user wear ear protection. Installation of the unit shall always permit the ventilation to work properly. Never hide the back of the unit (with a towel, etc.). Distance from a wall should be at least 10 cm. The device is disconnected from the supply network when the connector of power cord is disconnected from the device. The power cord connector must be accessible at any time Treatment locations and explanation of preset protocol can be found in section 18 appendix. Potential complications Potential side effects associated with this treatment include: •

Petechia,

•

Irritation,

•

Hematoma,

•

Swelling and numbness of the skin over the treatment area,

•

Pain and discomfort during and after treatment (anesthesia is not necessary),

•

Reddening of the skin. Please make sure that all side effects have subsided before resuming treatment.

Do not use in the presence of unexplained pain. If a patient reports significant or unexplained pain, immediately stop the treatment and consult a physician. Do not treat wounds, infected areas, skin tumors, open sores, or scars from recent surgery.

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1. INSTALLATION 1.1. COMPONENTS The components provided with your device will vary, according to your configuration.

1 7 4 8 2 9

5

3

6

10 Figure 1

REF

6

DESIGNATION

QTY

1

Console

1

2

Handpiece with 15-mm applicator (applied part)

1

3

Applicator set (see details in next page)

1

4

Cart - Optional

1

5

Handpiece holder kit

1

6

Power cord

1

7

Gel bottle

2

8

O-ring maintenance kit

1

9

Piston maintenance kit

1

10

Magnetic cord holder left

1

4 3

5

2

1

6 7

Figure 2 REF

DESIGNATION

QTY

1

Maintenance tool set for 25-mm and 40-mm applicators

2

2*

40-mm Applicator

1

3*

10-mm Applicator - Optional

1

4*

15-mm Applicator, Trigger – Optional

1

5*

15-mm Applicator, Focus – Optional

1

6*

25-mm Applicator - Optional

1

7*

5-mm Applicator - Optional

1

*EMS recommends to clean and disinfect the applicator prior to treating a patient. Please refer to instructions in section 7.

2 6

1

3

4

7

5

Figure 3 REF

DESIGNATION

1

Connector for the handpiece (applied part)

2

Handpiece holder

3

Air filter

4

Equipotential connector

5

Power connection

6

Mains power switch

7

Sub-D conector (for after sale service only)

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1.2. INSTALLING THE CONSOLE

3. Secure the console to the cart using the dedicated thumbscrew.

Install the console on a flat, stable surface or use the cart (optional) designed for the console.

1.2.1. Installing the Console on the Cart

All screws have to be pre-assembled without tightening them at first. Only tighten after they are all into the right place. 1. Ensure the brakes on the cart are activated before installing and using the device.

Figure 6 1.2.2. Installing the Handpiece Holder on the Unit

1. Use the screws and tool provided to secure the handpiece holder to the unit.

Figure 4 2. Place the console on the cart. Make sure that the feet are correctly inserted in the corresponding holes on the upper plate.

Figure 7 2. Ensure the handpiece holder is in the correct position.

Figure 5

Figure 8

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1.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR

2. Place the handpiece on the handpiece holder.

When applicable and according to your in-house protocol, connect the equipotential conductor at the rear of the console with the bus bar. The equipotential cable is not supplied with the console. The equipotential plug is used to prevent differences of potential between items of medical equipment that could generate measurement or treatment errors, if the medical device generates interference. In case of observed interference, the unit shall be connected to other devices used through this plug.

Figure 9 1.4. CONNECTING THE HANDPIECE TO THE CONSOLE 1. Connect the handpiece to the console. Pay attention to the orientation of the connector.

Figure 11 1.5. CONNECTING THE POWER CORD To avoid the risk of electric shock, this product must only be connected to a mains power supply with protective earth. 1. Connect the power cord to the power socket at the rear of the console.

Figure 10 The red dot must be on top for proper alignment.

Figure 12

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2. GETTING STARTED 2.1. STARTING THE DEVICE he mains power switch of the product must be T accessible at any time, to allow disconnection of the device. 1. Use the mains power switch located on the left side panel to switch on the console.

Figure 13 2.2. INTERFACES 2.2.1. Console Screen

2.0 bar

1

15 Hz

2

2500 Impulses

3

SMART PROTOCOL

4

Figure 14 REF

DESIGNATION

1

Pressure (from 1 to 4 bar), increment of 0.1 bar

2

Frequency (from 1 to 25 Hz), increment of 1 Hz

3

Pulses remaining in treatment

4

Selected preset protocol

This is not a touchscreen. Use the buttons on the console to navigate the menus.

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BUTTON

MEANING

ACTION

2.0 bar 15 Hz

Minus button

2.0 bar

2500 Impulses Plus button

15 Hz

SMART PROTOCOL

2.0 bar

2500 Impulses

15 Hz

SMART PROTOCOL

2500 Impulses

MART PROTOCOL

Use this button to decrease the value displayed on the screen. Use this button to increase the value displayed on the screen.

Preset protocol navigation buttons

Use these buttons to select a preset protocol. (See 5. Preset Protocols)

Analgesic special mode Press this button to activate the Analgesic special mode. selection button (See 6.1 Analgesic modes) Ramp-up special mode selection button

Press this button to activate the Ramp-Up special mode. (See 6.2 Ramp-up modes)

Burst special mode selection button

Press this button to activate the Burst special mode. (See 6.3 Burst modes) Table 1

2.2.2. Handpiece

1

2

3

Figure 15 REF

DESCRIPTION

ACTION

1

Pressure DOWN

Short-press: Decrease the pressure setting by 0.1 bar Long-press: Decrease the pressure setting by 0.2 bar increments

2

Pressure UP

Short-press: Increase the pressure setting by 0.1 bar Long-press: Increase the pressure setting by 0.2 bar increments

3

Trigger

Short-press: Start/pause treatment If Burst mode 2 is activated, hold down the trigger to activate manual Burst

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2.3. SOFTWARE AND HANDPIECE INFORMATION (NUMBERS OF USE) 1. Press and hold the three buttons simultaneously and hold them for 5 seconds.

2.4. SETTING THE LANGUAGE 1. Press the three special mode buttons simultaneously and hold them for 5 seconds.

2. The following screen appears. The Software version is displayed on page 1.

2.0 bar 15 Hz 2500 Impulses

Software version Main (ES-106):

1.1.3

Console HMI (ES-107):

0.8.18

Handpiece (ES-1002):

0.2.2

SMART PROTOCOL

Page 1

Figure 18 Figure 16

2. The following screen will appear:

3. Handpiece information is displayed on page 2. Press to display page 2. Do you want to perform a factory reset?

Handpiece information Piston: 0 treatments, 0 impulses (1000000 max impulses) Means: 0.0 bar, 0 Hz, 0 impulses

Yes

No

Handpiece: 0 treatments, 0 impulses Means: 0.0 bars, 0 Hz, 0 impulses

Page 2

Figure 19 Figure 17 EMS does not guarantee the performance of the treatment if the piston has reached its maximum recommended pulses. 4. To exit the Software and Handpiece information buttons simulscreen, press and hold the three taneously and hold them for 5 seconds.

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Changing the language will reset to factory settings. If you have saved a USER protocol, it will be deleted. 3. Press to confirm that you wish to perform a factory reset/change the language.

4. Press the or priate language.

buttons to select the appro-

Figure 20 5. To display more languages, use the button to view additional language options on subsequent pages.

2.5. STOPPING THE DEVICE 1. Use the mains power switch located on the left side panel to switch off the console

Figure 21

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3. TREATMENT 3.1. PREPARING THE PATIENT 1. Select the appropriate applicator (please refer to appendix A) and connect it to the handpiece. 2. Position the patient on the treatment bench.

Figure 24 5. Once the patient is installed and you have identified the area to be treated, apply a small amount of gel to the treatment area.

3. Localize the region to be treated by palpation. Find the area of maximum pain via palpation.

Figure 25 Figure 22 Use biofeedback from the patient to localize the affected muscle. 4. After localization, mark the skin to clearly identify the treatment area.

Use EMS SWISS DOLORCLAST® coupling gel for best results. Thanks to its special viscosity, the EMS gel transmits pressure pulses without leaking to ensure a perfect transmission throughout treatment.

6. Use the applicator to spread the gel on the treatment area.

3.2. TREATMENT SETTINGS (CHANGING APPLICATOR, PRESSURE, FREQUENCY, PULSES, ENERGY DENSITY) When you start the console, the default setting for the Smart protocol with a 15-mm applicator is 2 bar, 15 Hz, and 2500 pulses. Figure 23

The settings can be changed at any time during treatment.

3.2.1. Changing the Applicator

Use only EMS applicators for patient treatment. Refer to the Appendix to select the appropriate applicator for the indication Applicators are delivered ready to use. For more information on applicator maintenance, please refer to the “Maintenance” section.

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1. Ensure the O-ring is still in place with the spare applicator. If the O-ring is disconnected from the applicator, replace it.

3.2.2. Adjusting the Pressure

To adjust the shock wave depth and the energy transmitted into the tissue, increase or decrease the pressure. The pressure can be selected between 1 and 4 bar, in increments of 0.1 bar. 3.0 bar 15 Hz 2000 Impulses SMART PROTOCOL

Figure 26 If the O-ring is incorrectly positioned, this will cause the handpiece to malfunction.

Figure 29

2. Loosen and remove the applicator from the handpiece.

1. To increase the pressure, press the

button.

2. To decrease the pressure, press the

button.

3. Press and hold the of 0.2 bar.

button to obtain an increment

It is possible to adjust the pressure during treatment.

3.2.3. Adjusting the Frequency

Figure 27 3. Tighten the new applicator onto the handpiece. Ensure the applicator is completely tightened.

To adjust the number of pulses per second, increase or decrease the frequency. The frequency can be selected between 1 and 25 Hz, in increments of 1 Hz.

3.0 bar 15 Hz 2000 Impulses SMART PROTOCOL

Figure 30

Figure 28 4. The handpiece is ready to use.

1. To increase the frequency, press the

button.

2. To decrease the frequency, press the

button.

It is possible to adjust the frequency during treatment.

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3.2.4. Adjusting the Number of pulses

To adjust the total number of pulses transmitted to the patient, increase or decrease the number of pulses. The number of pulses can be selected between 500 and 5000, in increments of 500.

2. Select the size of the applicator used for treatment.

5 mm

10 mm

15 mm

15 mm Trigger

15 mm Focus

25 mm

Energy Density display off

Other applicators

3.0 bar 15 Hz 2000 Impulses SMART PROTOCOL

Figure 33 3. The energy density is now displayed next to the pressure setting. Figure 31 3 bar [0 J/mm ] 2

1. To increase the number of pulses, press the button. 2. To decrease the number of pulses, press the button.

15 Hz 2000 Impulses SMART PROTOCOL

3.2.5. Energy Density

You can display the energy density delivered to the patient. 1. Before starting treatment, press and hold the and buttons of the pressure settings simultaneously and hold them for 5 seconds.

Figure 34 4. At the end of the treatment, the total energy density is displayed. Press any button to exit the screen.

3.0 bar 15 Hz 2000 Impulses SMART PROTOCOL

Energy delivered:

15 mJ/mm

2

Applicator: 15mm Press any button to exit

Figure 32 Figure 35 When clicking on the bottom-right arrow, the console will show the following Figure 36 in the screen.

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On the treatment summary screen, if energy density is activated, the following screen will appear. The QR code of your console screen will lead you to an appropriate EMS contact page.

3.3.1. Handling the Handpiece

To maximize treatment efficiency, we recommend holding the handpiece with two hands, in two different ways: •

One hand up and one hand down

Information

Press any button to exit

Figure 36 5. To stop displaying the energy density, perform steps 1 and 2, and press to select “Energy Density display off”. 5 mm

10 mm

15 mm

15 mm Trigger

15 mm Focus

25 mm

Energy Density display off

Other applicators

This position will be used mainly for lower limb indications. •

Both hands down

Figure 37

3.3. PERFORMING TREATMENT Do not treat directly cracked or broken skin. If treatment is necessary, use a treatment interface such as an adhesive waterproof polyurethane film (for example, the OPSITE wound dressing from Smith&Nephew or equivalent) to protect the wounded area from direct contact with the applicator. If your hands are getting tired, take a pause before restarting a treatment.

Figure 38 This position will be used mainly for upper limb indications.

3.3.2. Starting Treatment

1. Activate the handpiece by applying a short press to the trigger

Ensure the applicator is cleaned and disinfected prior to treating a patient. Please refer to instructions in section 7.

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Figure 39 2. Once you start treatment and as you move the applicator around the treatment area, ask the patient to tell you if the treatment becomes uncomfortable and adjust the device settings accordingly. The application force exerted manually varies and depends on the indication. For patients with a very low pain threshold, treatment can be started with an Analgesic mode. Please refer to the “Special Modes” section for more information. 3.3.3. Pausing / ending the Treatment

When the remaining pulses reach “0”, the treatment automatically stops and the parameters return to the initial settings. If treatment is paused for more than 5 minutes, the treatment parameters return to the initial settings. 1. Press the trigger on the handpiece to pause treatment. 2. Place the handpiece in the handpiece holder. 3. Remove residual gel from the patient 4. Switch off the device 5. Disconnect the handpiece from the unit

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4. PRESET PROTOCOLS 4.1. DESCRIPTION OF PRESET PROTOCOLS You can use preset protocol settings as a starting point instead of adjusting each parameter of the default setting. Preset protocols are available to help you target treatment and increase efficiency. The 4 preset protocols are: PRESET PROTOCOLS

FACTORY SETTINGS

SMART Protocol

2 bar / 15 Hz / 2500 pulses

SMART Protocol 1

1.5 bar / 15 Hz / 3000 pulses

SMART Protocol 2

1 bar / 15 Hz / 3000 pulses

SMART Protocol 3

2 bar / 15 Hz / 3000 pulses Table 2

4.2. SELECTING THE PRESET PROTOCOLS 1. To select a preset protocol, use the and buttons. The name of the preset protocol is shown on the display along with the associated factory settings. 1.0 bar 15 Hz 3000 Impulses SMART Protocol 2

4.3. ADJUSTING THE PRESET PROTOCOLS You can modify a preset protocol to adapt the treatment. 1. To adjust the settings of a given preset protocol according to the patient’s treatment, first select the preset protocol. 2. Use the

and

buttons to adjust the settings.

For more information about how to adjust the settings, refer to the “Treatment Settings” section. 3. The new settings are displayed and an asterisk * appears after the protocol’s name to specify that this preset protocol has been customized.

Figure 40 2. Press the trigger on the handpiece to start treatment.

2.5 bar 15 Hz 2500 Impulses SMART Protocol 2*

Figure 41

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4.4. SAVING ADJUSTED PRESET PROTOCOLS You can easily save the settings you customized for a given preset protocol. 1. To record the newly customized settings for a given preset protocol, press and hold the and buttons simultaneously for 2 seconds.

2.5 bar 15 Hz 2500 Impulses SMART Protocol 2*

Figure 42 2. The newly customised settings are now considered to be the default settings for the selected preset protocol. 3. The asterisk * is no longer present and USER will be displayed to indicate that the new preset protocol settings have been recorded as the new default settings. Only a factory reset will allow you to access the previous settings of a selected preset protocol. 2.5 bar 15 Hz 2500 Impulses SMART Protocol 2 USER

Figure 43 4. The preset protocols can be adjusted using the and buttons and saved for subsequent use.

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EMS Swiss

DolorClast Radial Instructions for Use Rev A