User Manual · 2021. 1. 20. · PainShield® MD is intended for use in the electromagnetic...

UserManual

Cat. # 20-100-0005 Ver. 06 (ROW)

PainShield® MD User Manual

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Without prior notice and without obligation, the contents of this manual may be revisedto incorporate changes and improvements.Every effort is made to ensure that the information is complete and accurate at the timeof publication. Nevertheless, NanoVibronix cannot be held responsible for errors oromissions.Trademarks, patents, and copyrights apply.

NanoVibronix Inc.,525 Executive Boulevard,Elmsford, N.Y. 10523, USATel.: 1 (914) 233-3004Fax: 1 (914) 376-6111Email: [email protected]: www.nanovibronix.com

Manufactured by:

NanoVibronix Ltd,9 Derech Hashalom St,Nesher 36651, Israel.Tel: +972–4-8200581Fax: +972-4-8202794E-mail: [email protected] site: www.nanovibronix.com

Authorized representative in the European Community:CEpartner4U BVEsdoornlaan 13,3951 DB Maarn,The NetherlandsTel.: +31.343.442.524Mobile: +31.6.516.536.26Fax: +31.343.442.162Email: [email protected]


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Table of Contents1. Introduction ...................................................................................................... 4

1.1. General Safety............................................................................ 42. Indications for Use ............................................................................................ 5

3. Safety……….…………………………………………………………………………………………………...6

3.1. Contraindications....................................................................... 6

3.2. Warnings .................................................................................... 7

3.3. Precautions ................................................................................ 94. Product Features............................................................................................. 10

4.1. Preset Treatment ..................................................................... 10

4.2. Battery Operation .................................................................... 10

4.3. PainShield® MD Adhesive Patches........................................... 105. Product Components ...................................................................................... 11

5.1. The PainShield® MD Treatment Actuator ................................ 11

5.2. The PainShield® MD Driver ...................................................... 126. Operation ……………………………………………………………………………………………………13

6.1. Charging the Driver .................................................................. 13

6.2. Preparing the Treatment Area ................................................. 14

6.3. Preparing the Actuator for Use ................................................ 14

6.4. Preparation for Trigeminal Neuralgia Treatment..................... 16

6.5. Applying Therapy ..................................................................... 17

6.6. Monitoring PainShield® MD...................................................... 18

6.7. Removing the Actuator Patch .................................................. 20

6.8. Replacing the Actuator ............................................................ 217. Frequently Asked Questions ........................................................................... 22

8. Product Care ................................................................................................... 23

Appendix A: Electromagnetic Compliance ......................................................... 24

Appendix B: Specifications ................................................................................. 27

Appendix C: Labels ............................................................................................. 28

Appendix D: Symbols.......................................................................................... 29

Appendix E: Warranty........................................................................................ 30

Appendix F: Troubleshooting............................................................................. 31


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1. Introduction

Thank you for choosing the PainShield® MD. This manual contains precautionsand general instructions for the operation, application and care of PainShield®MD. In order to obtain maximum lifetime and efficiency from PainShield® MDand to ensure it is properly operated, please read and understand this manualthoroughly. PainShield® MD is to be used only as directed in this manual.

PainShield® MD uses ultrasound therapy for the relief of acute or chronic painand muscle spasms.

PainShield® MD was developed as a next generation wearable ultrasoundsystem which transforms conventional therapeutic ultrasound technology intoa small and portable ultrasound therapy unit. It is designed to work along withthe human body and maximize the safe and effective delivery of a long-duration therapeutic effect.

PainShield® MD is simple to administer, and operates on a broad range of bodyareas, allowing the delivery of ultrasound treatment for up to 6.5 hours, at apreset frequency of 90 kHz. Treatment is delivered via an ultrasound actuator,which is applied and secured to the surface of the body using single-useadhesive patches.

1.1. General Safety

Please thoroughly read and understand the precautionary and operatinginstructions before attempting to operate PainShield® MD. Know thelimitations and hazards associated with using any ultrasound device. Observethe precautionary and operational labels on the product. Periodically reviewthe operation procedures and safety precautions outlined in this manual.


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2. Indications for Use

PainShield® MD is intended to apply ultrasonic energy to generate deep heatwithin body tissues for the treatment of selected medical conditions. The lowintensity and low frequency ultrasound energy is effective within a diameter of20 cm and a depth of approximately 3 cm. The PainShield® MD can thereforebe 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


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3. Safety

3.1. Contraindications

PainShield® MD 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


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3.2. Warnings

WARNING

Do not use PainShield® MD in the presence offlammable materials and liquids. PainShield® MDis classified as an internally-powered,intermittently-operated, ordinary equipment witha disposable type BF applied part.

Do not immerse any part of PainShield® MD inwater or any other liquid.

Use PainShield® MD only as instructed in thismanual.

Do not use any part of PainShield® MD thatappears damaged.

Do not modify PainShield® MD in any way.

Do not replace any part of PainShield® MD withcomponents or parts other than those supplied byNanoVibronix.

Do not connect PainShield® MD to any device orsystem other than the parts supplied with it.

Use of this equipment adjacent to or stacked withother equipment should be avoided because itcould result in improper operation. If such use isnecessary, this equipment and the otherequipment should be observed to verify that theyare operating normally.

Use of accessories, transducers and cables otherthan those specified or provided by themanufacturer of this equipment could result inincreased electromagnetic emissions ordecreased electromagnetic immunity of thisequipment and result in improper operation.


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WARNING

Portable RF communications equipment (includingperipherals such as antenna cables and externalantennas) should be used no closer than 30 cm (12inches) to any part of the PainShield® MD,including cables specified by the manufacturer.Otherwise, degradation of the performance of thisequipment could result.

PainShield® MD needs special precautionsregarding EMC and needs to be installed and putinto service according to the specific instructionsfor maintaining basic safety and essentialperformance with regard to electromagneticdisturbances for the expected service life providedin Appendix A of this manual.

The PainShield® is not MRI compatible andtherefore, should be removed before entering theMRI suite.

CAUTION

PainShield MD is intended for use in Professionalhealthcare facility with attending medical staff andHome healthcare as defined in collateral standardIEC 60601-1-11, as dwelling places where patientslive or are present (excluding professionalhealthcare facilities mentioned above). Hereequipment will be used by non-specialist users andequipment must also be tolerant of poor electricalsupplies.

Charge PainShield® MD only using the suppliedcharger.

Do not attempt to open or remove the cover ofPainShield® MD.

The lithium ion rechargeable battery in PainShield®MD must not be disassembled, heated above 100degrees Celsius, incinerated, or exposed to water.

Be aware of the actuator cable winding around theneck that may lead to injury and strangulation.


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3.3. Precautions

Use PainShield® MD 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 afteruse.

The safety and effectiveness of PainShield® MD has not beenestablished in patients who are or have been treated by othermedical devices including but not limited to:

- Pacemakers

- Electrical stimulators

- Radiofrequency generators

- Surgical meshes

- Intra-Uterine devices (IUDs)

- Other surgical implants.

When the actuator is warn in a location you are lying on you mayexperience slight redness of the skin, which will resolve in a fewhours.


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4. Product Features

4.1. Preset Treatment

PainShield® MD is preconfigured to provide intermittent ultrasonic output at apreset frequency of 90 kHz and low intensity, neither of which can be modifiedby the user.

When in ON mode, PainShield® MD alternates automatically between 2phases:

Active phase—PainShield® MD delivers 30 minutes of ultrasoundtherapy.

Idle phase—PainShield® MD is idle for 30 minutes.

1 active phase + 1 idle phase = 1 cycle.

PainShield® MD automatically switches to OFF mode after 6.5 hours, at whichpoint, the battery should be recharged.

4.2. Battery Operation

Powered by a rechargeable lithium-ion battery, PainShield® MD can provide6.5 hours of continuous therapy on a single battery charge. After 6.5 hours,PainShield® MD automatically switches off, and the battery must be recharged.

You can switch PainShield® MD to OFF mode, manually, at any point of time.

4.3. PainShield® MD Adhesive Patches

The adhesive patches secure the actuator to the affected area. The actuatorconverts energy to ultrasonic therapeutic waves.


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5. Product Components

PainShield® MD has two main components: a treatment actuator and a driver.A charger is included in every kit.

5.1. The PainShield® MD Treatment Actuator

The treatment actuator incorporates an ultrasonic transducer and connects tothe driver with a cable.

The transducer is the active element that converts electric signals toultrasound waves.

For effective treatment the transducer must be in full contact with the skin.


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5.2. The PainShield® MD Driver

The driver that supplies electrical signals to the transducer in the actuator hasthe following parts:

Built-in rechargeable battery

Charging port

Actuator port

ON/OFF button

Operation screen display


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6. Operation

6.1. Charging the Driver

When the battery is fully charged, the driver has an operating life of 6.5 hours.

Charge the driver in accordance with the following guidelines:

Charge the driver only with the supplied charger.

Therapy is not available while the driver is being charged.

Before first use, remove the driver from its packaging and verify thatit is fully charged.

To charge the driver:

1. Connect the mini USB plug of the supplied charger to the driver’scharging port.

2. Plug the charger into a wall outlet.

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

After approximately 1 minute, the screen dims. To refresh thedisplay, briefly press the ON/OFF button.

During charging the battery icon fills gradually.


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Charging takes about 2 hours. When the battery is fully charged, the batteryicon appears full.

6.2. Preparing the Treatment Area

1. Remove excess hair from the treatment area.

2. Clean the treatment area thoroughly with soap and water or analcohol prep pad.

3. Dry the treatment area.

6.3. Preparing the Actuator for Use

1. Remove the actuator from its packaging and connect the actuatorplug into the driver socket, making sure to orient the plug correctly inrelation to the socket, and make sure the plug is fully inserted andsecured.


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2. Remove the center protective layer from the adhesive leaving theouter strips attached to insure easy placement.

3. Place the actuator on the exposed adhesive at the center of thepatch, with the metal transducer facing up and the wire aligned withthe open notch in the patch.

4. Remove the 2 outer protective liners from the adhesive.


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5. Attach the actuator patch to the skin, with the adhesive side downover the area where the pain is most intense.

6. If the skin is broken or if the pain is located near a joint, attach theactuator on flat healthy skin area adjacent to the source of pain. Besure to place the actuator within 10cm (4 inches) of the effectivearea to ensure the pain source within the treatment area.

6.4. Preparation for Trigeminal Neuralgia Treatment

PainShield® MD has been found highly effective in relieving Trigeminal Neuralgia(TN) pain. In rare cases some patients may feel an initial pain increase beforeexperiencing the benefit of the treatment. It is therefore recommended that youproceed gradually, applying treatment first for 2-3 hours then graduallyincreasing up to 6.5 hours as tolerated. Apply the first and second treatmentswhile you are awake. You can subsequently apply treatment during sleep. If youuse PainShield® MD overnight, remove it on waking up.


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1. Follow 6.3 preparation steps 1-4 above, using the small patch.

2. Place the actuator patch next to the cheekbone when the pain is inthe maxillary nerve (V2) or next to the lower jaw bone when the painis in the mandibular nerve (V3).

If local sensitivity makes patch application painful, apply the patch tothe forehead on the pain-free side.

3. Make sure that the transducer is in full contact with the skin.

6.5. Applying Therapy

Use the ON/OFF button to switch the driver ON and OFF.

To switch the driver ON:

Press the ON/OFF button until you hear a beep and the NanoVibronixlogo appears on the screen.

To switch the driver OFF:

Press the ON/OFF button until you hear the shut-off beep.

Note: Briefly pressing the ON/OFF button refreshes the information screen.The screen saver is replaced by the information screen.


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6.6. Monitoring PainShield® MD

The driver screen displays information in respect of the functioning ofPainShield® MD. The table below explains the symbols and text that may bedisplayed on the screen at various times.

Symbols/Text Displayed Explanation

Manufacturer name(displayed briefly when you switch ONthe driver)

Product nameSoftware version number(displayed briefly in the interval beforethe information display appears)

Working mode information(ACTIVE phase)

1. Battery indicator2. Treatment cycle number (C1 to C6)3. Output power4. Time elapsed since the beginning of

the current ACTIVE phase.

① ② ③

④


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Working mode information(IDLE phase)

1. Battery indicator2. Treatment cycle number3. Output power4. PainShield® MD is in IDLE phase.

Screensaver during working mode(automatically replaces the informationscreen after 3 minutes)

PainShield® MD is ON.

To refresh the display of information,briefly press the ON/OFF button.

The battery is discharged and requiresrecharging.

Charging mode information

The battery icon fills gradually to showcharging progress.

① ② ③

④


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Screensaver in Charging Mode

The display is dimmed and keeps scrollingvertically.To refresh the display of informationpress the ON/OFF button briefly (that is,for less than 2 seconds).

The actuator is damaged or notconnected to the driver.

The driver is switching OFF

Switching off takes 3 seconds. Thenumber indicates how many seconds tocomplete shut off.

6.7. Removing the Actuator Patch

1. Use caution when gently removing the actuator patch from the skin.

2. Gently remove the patch from the actuator using caution andavoiding applying tension to the wire.

IMPORTANT Do not use the patch more than once, so as not tojeopardize actuator performance.


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6.8. Replacing the Actuator

It is recommended to replace the actuator after 30 treatments.New actuators can be ordered from NanoVibronix or your local distributor.

1. Switch OFF the PainShield driver (to prevent the driver from soundingan alert when it is disconnected from the actuator).

2. Hold the driver in one hand and the actuator cable plug in the otherhand and then pull them apart.

3. Connect the new actuator cable plug into the driver socket, makingsure to orient the plug correctly in relation to the socket, making surethat the plug is fully inserted and secured.


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7. Frequently Asked Questions

Question Answer

How do I place the actuatorcorrectly?

Place the actuator on clean, dry, healthy skin over orclose to the source of pain and in full contact with theskin.

Do I need to use anultrasound gel under thePainShield® MD actuator?

You do not need to use ultrasound gel with thePainShield® MD.

Can I put the actuator overan open wound?

The actuator should never be placed on an open wound;it should be placed on healthy skin near the wound.

Will I feel any vibrations orshocks from PainShield®MD when it is on?

Other than mild warmth from the metal active elementin the actuator you will feel no vibrations or shocks.Following treatment, some redness might occur in thetreated area. This redness resolves on its own within afew hours.

When will I feel relief? Pain reduction could begin as early as 30 minutes aftertreatment and last up to several days. PainShield® MDworks by improving blood flow to muscles and tissuesthat are in spasm and by normalizing nerve activity.

How can I order additionalactuators or patches?

Please contact NanoVibronix or your local distributor.

Can PainShield® MD beused with physical therapy.

Yes. PainShield® MD is perfectly suited for use inconjunction with a program of physical therapy and canbe used in between therapy sessions.


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8. Product Care

PainShield® MD storage conditions:

Temp: 5 °C - 40 °C;

Humidity: 10% - 80%;

Atmospheric pressure range: 700-1060 hPa.

PainShield® MD operating conditions:

Temp: 5 °C - 35 °C;

Humidity: 10% - 80%;

Atmospheric pressure range: 700-1060 hPa.

The driver is intended to undergo up to 400 charging cycles.

The life expectancy of the driver is 2 years.

To clean the driver use disinfectant medical wipes. Do not use solvents (such asacetone) as they may damage the product.

The driver is flame resistant according to UL-94HB. It does not containflammable materials and will not accelerate a fire. The driver is not intendedfor use in the presence of flammable liquids.

Use the actuator with a new patch for each treatment session.

A faulty unit which is still under warranty, can be sent to NanoVibronix forreplacement.

Do not immerse any part of PainShield® MD in water or any other liquid.


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Appendix A: Electromagnetic Compliance

Table 1: PainShield® MD Electromagnetic Emission

Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsPainShield® MD is intended for use in the electromagnetic environment specified below.The customer or user of the PainShield® should assure that it is used in such anenvironment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissionsCISPR 11

Group 1

The PainShield MD uses RF energy only for itsinternal function. Therefore, its RF emissions are

very low and are not likely to cause anyinterference in nearby electronic equipment

RF emissionsCISPR 11 Class B

The PainShield MD is suitable for use in allestablishments, including domestic establishments

and those directly connected to the public low-voltage power supply network that supplies

buildings used for domestic purposes.

Harmonicemissions

IEC 61000-3-2Class A

Voltagefluctuations/flicker

emissionsIEC 61000-3-3

Complies


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Table 2: PainShield® MD Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

PainShield® MD is intended for use in the electromagnetic environment specified below. The customer oruser of the PainShield® MD should assure that it is used in such an environment.

Immunity test IEC 60601 levelCompliancelevel

Electromagnetic environment -guidance

Electrostaticdischarge (ESD),IEC 61000-4-2

8 kV contact15 kV air

8 kV contact15 kV air

Floors should be wood, concrete or ceramictile. If floors are covered with syntheticmaterial, the relative humidity should be atleast 30 %.

Electrical fasttransient/burst,IEC 61000-4-4

2 kV for powersupply lines1 kV for SIP/SOPlines

2 kV for powersupply lines

Mains power quality should be that of atypical commercial or hospital environment

Surge, IEC61000-4-5

1 kV line to line2 kV line to earth

1 kV line to line(Class II MEequipment)

Mains power quality should be that of atypical commercial or hospitalenvironment.

Voltage dips andinterruptions onpower supplyinput linesIEC 61000-4-11

0 % UT for 0,5cycle0 % UT for 1 cycle70 % UT for25/30 cycles0 % UT for250/300 cycles

0 % UT for 0,5cycle0 % UT for 1cycle70 % UT for25/30 cycles0 % UT for250/300 cycles

Mains power quality should be that of atypical commercial or hospitalenvironment. The user of the PainShieldMD during continued operation not dependfrom power mains interruptions, becausePainShield MD powered from a batteries.During system charging is recommendedthat the PainShield MD be powered froman uninterruptible power supply.

Power frequencymagnetic field,IEC 61000-4-8

30 A/m 30 A/m

Power frequency magnetic fields should beat levels characteristic of a typical locationin a typical commercial or hospitalenvironment.

NOTE: UT is the AC mains voltage prior to application of the test level.


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Table 3: PainShield® MD Electromagnetic Immunity (Continuation)

PainShield essential performance

PainShield produces low frequency, low intensity ultrasonic waves for the reliefof pain, muscle spasm and improvement of local circulation. The ultrasonicwaves are generated by a transducer that is incorporated into the actuator.

Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityPainShield® MD is intended for use in the electromagnetic environment specified below. The customeror user of the PainShield® MD should assure that it is used in such an environment.Immunity test IEC 60601 level Compliance levelIEC 61000-4-6Conducted RF

3 Vrms150 kHz to 80 MHz6 Vrms in ISM bands (6.765 MHz to 6.795MHz; 13.553 MHz to 13.567 MHz; 26.957 MHzto 27.283 MHz; and 40.66 MHz to 40.70 MHz)and amateur bands (1.8 MHz to 2.0 MHz, 3.5MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHzto 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHzto 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz,28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0MHz)

[V] = 3 Vrms

[V] = 6 Vrms

IEC 61000-4-3Radiated RF

10 V/m80 MHz to 2.7 GHz

[E] = 10 V/m

Proximity fields fromRF wirelesscommunicationsequipment

385 MHz 27 V/m450 MHz 28 V/m710 MHz

9 V/m745 MHz780 MHz810 MHz

28 V/m870 MHz930 MHz1720 MHz

28 V/m1845 MHz1970 MHz2450 MHz 28 V/m5240 MHz

9 V/m5500 MHz5785 MHz


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Appendix B: Specifications

Driver model FD-14A

Frequency: 90 kHz ± 0.001 kHzVoltage output: 12 V p-pCurrent output: Up to 0.3 A RMSRechargeable battery: Lithium-Ion, 3.7V, 1250mAh (full charging time ~ 2 h)Dimensions: 137 mm (L) x 47 mm (W) x 21 mm (H)Weight: Approximately 85 gHousing: ABS

Treatment Actuator:

Acoustic power: 0.4 WFrequency: 90 kHz ± 0.001 kHzBeam Non Uniformity Ratio(BNR)

6:1

Effective Radiating Area (ERA) 6 cm²Dimensions 35 mm x 27 mm x 6 mmWeight 12 gReuse Approximately 30 applications

Charger:

1st : Voltage input: 100-240 VAC, 0.4-0.2A, 50/60 HzOutput: 5 VDC, 2.4 A

2nd : Voltage input: 100-240 VAC, 0.5A, 50/60 HzOutput: 5 VDC, 2.4 A

Note: Use an appropriate adaptor for local mains.

Product classificationLow risk device classification:CE mark- Class II aFDA clearance- Class II

Compliance with standardsIEC 60601-1; IEC-60601-1-2ISO 10993-1.


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Appendix C: Labels

Figure 1, Figure 2, Figure 3 and Figure 4 show PainShield® MD labels.

Output Frequency:90kHz

Type: DivergentWaveform: CW

BNR 6:1, ERA=6cm²Acoustic power: 0.4W

P/N 10-800-0002

NanoVibronix Ltd. 9Derech Hashalom St, Nesher3665112, Israel

2019-12

00167

Adaptor: UES18LCP-050240SPAInput: 100-240VAC, 50/60Hz, 500 mAOutput:5VDC, 2.4A

CEpartner4U BVEsdoornlaan13, 3951 DB Maarn, Netherlands

PainShield MD

IP221282

Figure 1: Driver Label

Figure 2: Actuator pouch label Figure 3: Kit label

Figure 4: Patches pouch labels


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Appendix D: Symbols

CE mark

Refer to instruction manual/booklet

Type of BF applied part

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

The product must be disposed of together with domestic waste. All usersare obliged to hand in all electrical or electronic devices, regardless ofwhether or not they contain toxic substance, at a municipal or commercialcollection point so that they can be disposed of in an environmentallyacceptable manner. Consult your municipal authority or your dealer forinformation about disposal.

Manufacturer

Date of manufacture (YYYY-MM)

Authorized representative in the European Community

P/N Part number S/N Serial number

0.4W Power output 0.4 watts CW Continuous Wave

LOT mW/cm2

Milliwatt per squarecentimeter

BNR Beam Non-uniformity Ratio cm2 Square centimeter

ERA Effective Radiating Area W Watt (1W = 1000mW)

kHz Kilohertz (1 kHz = 1000 Hz)

IP22 IP rating per IEC60529


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Appendix E: Warranty

NanoVibronix warrants that the PainShield® MD driver shall be defect-free fora period of one year from product date of shipment.

The liability of NanoVibronix under this warranty is limited to the repair orreplacement (at NanoVibronix’s choice) of any allegedly defective part or partsunder warranty by NanoVibronix and at its expense. The defective driver shallbe returned to NanoVibronix accompanied by a notice that describes thenature of the problem.

This warranty shall not apply to a product which has been subject to misuse,unauthorized use, negligence or accident (including but not limited to fire,water, explosion, smoke, or vandalism), or which has not been operated incompliance with NanoVibronix' instructions of use.

Without derogating from the above, this warranty is void, if at any time anyoneother than NanoVibronix authorized personnel removes the product casingand/or attempts to make any internal changes, removals, attachments oradditions to the product or its components.


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Appendix F: Troubleshooting

Issue or Problem Solution

The device does not turn on Charge the driver using the suppliedcharger for 2 hours.If issue is not resolved, contact theNanoVibronix local distributor

The actuator is not staying securedto the skin during treatment

Turn off the device. Remove theactuator patch (See 6.7). Replace witha new adhesive patch (See 6.3).

An empty battery icon is displayedon screen and an audio alert isplayed

The battery is discharged and requiresrecharging (See 6.1)

The screen displays actuatordisconnection status icon and anaudio alert is played

The actuator is damaged or notconnected to the driver. Try andreconnect to driver and if it still fails,replace with new actuator (See 6.8).

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