medisana PT 100 Painshield Ultrasonic Therapy Instruction Manual

medisana PT 100 Painshield Ultrasonic Therapy

Explanation of symbols

• IMPORTANT
  Non-observance of these instructions can result in serious injury or damage to the device.

• WARNING
  These warning notes must be observed to prevent any injury to the user.

• CAUTION
  These notes must be observed to prevent any damage to the device.

• NOTE
  These notes give you useful additional information on the installation or operation.

• Type BF applied part

• LOT number

• Rated frequency or rated frequency range(s) (Hz)

• Beam Non-uniformity Ratio

• Part number

• Serial number

• Effective Radiating Area

• Watts (1W = 1000mW)

• Power output 0.4 watts

• Continuous Wave

• Square centimeter

• Milliwatt per square centimeter

• Kilohertz (1 kHz = 1000 Hz)

• IP rating per IEC60529

• Authorized representative in the EC

• Manufacturer

• Date of manufacture

Safety Instructions

Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on these instructions for use.

• The device must only be used for its intended purpose as described in the instruction manual. Using the appliance for any other purpose invalidates the warranty.
• Do not immerse the device in water or other fluids.
• Always carefully inspect the device for damage before use. Do not attempt to use a defective unit.
• Do not dismantle or modify the device in any way.
• Do not use the device in the presence of flammable materials and liquids. The device is classified as internally-powered, intermittently-operated, ordinary equipment with a disposable type BFapplied part.
• Do not replace any part of the device with components or parts other than those supplied by the manufacturer.
• Do not connect the device to any device or system other than the parts supplied with it.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• This device needs special precautions regarding EMC and needs to be installed and put into services according to the specific instructions for maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service life provided.
• The device is intended for use in professional healthcare facilities with attending medical staff and home healthcare as defined in collateral standard IEC 60601-1-11, as dwelling places where patients live or are present (excluding professional healthcare facilities mentioned above). Here equipment will be used by non-specialist users and equipment must also be tolerant of poor electrical supplies.
• Charge the PT 100 only using the supplied charger.
• Do not attempt to open or remove the cover of the device.
• The lithium-ion rechargeable battery must not be disassembled, heated above 100 degrees Celsius, incinerated, or exposed to water.
• Be aware of the actuator cable winding around the neck which may lead to injury and strangulation.
• Use the device with caution in the following areas:
  • Following a laminectomy involving major tissue removal
  • In patients susceptible to bleeds
  • Over-anesthetized areas of impaired skin
• Treatment of children should be performed under adult supervision.
• In children, avoid use over the epiphyseal growth plate area.
• Use caution when removing the actuator patch from the skin after use.
• The safety and effectiveness of this device have not been established in patients who are or have been treated by other medical devices including but not limited to:
  • Pacemakers
  • Electrical stimulators
  • Radiofrequency generators
  • Surgical meshes
  • Intra
  • Uterine devices (IUDs)
  • Other surgical implants.
• When the actuator is warned in a location you are lying on you may experience slight redness of the skin, which will resolve in a few hours.

Indications for Use

This device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions. The low- intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm. The device can therefore be effective in treating a wound without direct contact with it.

Selected medical conditions for treatment include:

• Pain (including Trigeminal Neuralgia)
• Muscle spasms
• Joint contractures/injury
• Provides improvement in local blood circulation
• Assists in soft tissue healing including post-surgery
• Assists in healing chronic (such as diabetic) wounds
• Improves penetration of topical ointment or gel

Contraindications

The device is prohibited for use in the following cases:

• Patients with cancer and bone metastases under treatment area
• Directly on the eye
• Directly over an open wound
• Directly over ischemic tissues in individuals with vascular disease
• Over the uterus in pregnant patients
• Over bone growth centers until bone growth is complete

Device and controls

1. Charging port
2. Connection for ultrasound actuator
3. On-/Off-button
4. Display
5. Actuator pad (front and back side)
6. Ultrasound actuator
7. Battery symbol
8. Treatment cycle number (C1 to C6)
9. Output power in watt
10. Time elapsed in the active phase

Scope of supply

Please check first of all that the device is complete and is not damaged in any way. In case of doubt, do not use it and contact your dealer or your service center.

The following parts are included:

• 1 medisana Painshield Ultrasonic therapy PT 100
• 1 Actuator pad
• 1 Charger
• 1 Instruction manual
• 30 single-use adhesive pads

If you notice any transport damage during unpacking, please contact your dealer without delay.

WARNING
Please ensure that polythene packing is kept away from the reach of children! Risk of suffocation!

Charging the battery

With fully charged battery, the using time of the device is approx. 6.5 hours. Charge the battery in accordance with the following guidelines:

• Charge the battery only with the supplied charger.
• Therapy is not available while the battery is being charged.
• Before first use, remove the device from its packaging and verify that it is fully charged.
• Charging the battery:
  • Connect the mini USB plug of the supplied charger to the driver’s charging port 1.
  • Plug the charger into a wall outlet.

When the driver begins to charge, the screen lights up brightly and displays the battery icon:

• After approximately 1 minute, the screen dims. To refresh the display, briefly press the ON/OFF button 3. During charging the battery icon fills gradually. Charging takes about 2 hours.

When the battery is fully charged, the battery icon appears full:

Preparation

Remove excess hair, jewellery, etc. from the treatment area. Clean the treatment area thoroughly with soap and water or an alcohol prep pad. Dry the treatment area. Remove actuator 6 from its packaging and connect the actuator plug to the driver socket 2, making sure to orient the plug correctly in relation to the socket, and make sure the plug is fully inserted and secured.

Attach pad

1. Remove the center protective layer from the adhesive of pad 5 leaving the outer strips attached to insure easy placement.
2. Place actuator 6 on the exposed adhesive at the center of the patch, with the metal transducer facing up and the wire aligned with the open notch in the patch.
3. Remove the 2 outer protective liners from the adhesive.
4. Attach the actuator patch to the skin, with the adhesive side down over the area where the pain is most intense.

NOTE
If the skin is broken or if the pain is located near a joint, attach the actuator to a flat healthy skin area adjacent to the source of pain. Be sure to place the actuator within 10cm (4 inches) of the effective area to insure the pain source is within the treatment area.

Attach pad for trigeminal neuralgia treatment
For trigeminal neuralgia treatment, place the actuator patch next to the cheekbone when the pain is in the maxillary nerve or next to the lower jaw bone when the pain is in the mandibular nerve. If local sensitivity makes patch application painful, apply the patch to the forehead on the pain-free side.

NOTE
In rare cases, some patients may feel an initial pain increase before experiencing the benefit of the treatment. It is therefore recommended that you proceed gradually, applying treatment first for 2-3 hours then gradually increasing up to 6.5 hours as tolerated. Apply the first and second treatments while you are awake. You can subsequently apply treatment during sleep. If you use the device overnight, remove it on waking up.

Use

1. Make sure that the transducer is in full contact with the skin.
2. Switch on: Press the ON/OFF button 3 until you hear a beep and the company logo appears on the screen
3. Switch off: Press the ON/OFF button 3 until you hear the shut-off beep.
   Hint: Briefly pressing the ON/OFF button 3 refreshes the information screen.

The display
In addition to the battery symbol 7, treatment cycle number 8, the output power in watt 9, and time elapsed 0 also the company logo, the software version, an error message (see chapter „Errors and remedying“), „IDLE“ for the idle phase or a 3-second switch-off-countdown may be displayed, depending on the current operating mode.

Removing the actuator pad 5
Use caution when gently removing the actuator patch from the skin. The adhesive pad 5 is only intended to be used once – dispose of it accordingly after use.

Exchange the ultrasound actuator 6
The actuator 6 should be replaced after approx. 30 treatments. To exchange it, proceed as follows:

1. Switch OFF the PainShield driver (to prevent the driver from sounding an alert when it is disconnected from the actuator).
2. Disconnect the cable of actuator 6 from port 2.
3. Connect the new actuator cable plug into the driver socket 2.

Errors and remedying

• Error: The device does not turn on.
• Remedying: Charge the driver using the supplied charger for 2 hours. If the issue is not resolved, contact customer service.
• Error: The actuator pad is not staying secured to the skin during treatment.
• Remedying: Turn off the device. Remove the actuator pad and replace it with a new adhesive pad – these are intended for single use only.
• Error: An empty battery icon is displayed on the screen.
• Remedying: The battery is discharged and requires recharging.
• Error: The screen displays a symbol like this:
• Remedying: The actuator 6 is damaged or not connected to the driver. Try and reconnect to the driver and if it still fails, replace it with the new actuator.

Cleaning and maintenance

• Before cleaning the unit, make sure it is switched off. Clean the unit with a soft, dry cloth or disinfectant medical wipes.
• Under no circumstances should you use aggressive detergents, strong brushes, solvents, or alcohol, as they may damage the surface of the unit.
• When cleaning, never immerse the unit in water, and make sure that no water gets into the unit.
• You should ideally store the device in its original packaging and keep it in a clean, dry place.

Disposal

This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner. Consult your municipal authority or your dealer for information about disposal.

Technical Specifications

• Name and model: medisana Painshield Ultrasonic therapy PT 100
• Ultrasound frequency: 90 kHz ± 0.001 kHz
• Voltage/current output: 12 V p-p/up to 0.3 A RMS
• Rechargeable battery: Lithium-Ion, 3.7V, 1250mAh (charging time approx. 2 h)
• Charger:
  • Input: 100-240 VAC, 0.4-0.2A, 50/60 Hz
  • Output: 5 VDC, 1 A
• Active/idle phase: 30 min / 30 min = 1 treatment cycle
• Automatic switch-off: after 6.5 hours
• Lifespan: 2 years resp. 400 treatment cycles
• Actuator power: 0.4 W
• Beam Non-Uniformity Ratio (BNR): 6:1
• Effective Radiating Area (ERA): 6 cm²
• Dimensions approx.:
  • Device: 137 mm (L) x 47 mm (W) x 21 mm (H)
  • Actuator: 35 mm x 27 mm x 6 mm
• Weight approx.: Device: 85 g / Actuator: 12 g
• Operating conditions:
  • Temperature: +5 to +35°C; rel. humidity 10-80%,
  • Atmospheric pressure 700-1060 hPa
• Storage conditions:
  • Temperature: +5 to +40°C; rel. humidity 10-80%,
  • Atmospheric pressure 700-1060 hPa
• Item number: 88346
• EAN number: 40 15588 88346 0

In accordance with our policy of continual product improvement, we reserve the right to make technical and visual changes without notice. The current version of this instruction manual can be found at www.medisana.com.

Warranty and repair terms

Please contact your dealer or the service center in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1. The warranty period for medisana products is three years from the date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.
2. Defects in material or workmanship will be removed free of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
   • All damage that has arisen due to improper treatment, e.g. non-observance of the user instructions.
   • All damage is due to repairs or tampering by the customer or unauthorized third parties.
   • Damage that has arisen during transport from the manufacturer to the consumer or during transport to the service center.
   • Accessories that are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim.

NanoVibronix Ltd,
9 Derech Hashalom St, Nesher 36651, Israel.
Tel: +972–4-8200581, Fax: +972-4-8202794, E-mail: info@nanovibronix.com.

CEpartner4U BV,
Esdoornlaan 13, 3951 DB Maarn, The Netherlands
Tel.: +31.343.442.524, Mobile: +31.6.516.536.26, Fax: +31.343.442.162Email: office@CEpartner4U.nl.

Imported & distributed by:
medisana GmbH, Carl-Schurz-Str. 2, 41460 NEUSS, GERMANY.

References

• medisana – Your health in good hands
• Home page medisana – Your health in good hands

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