VISSCO JUS 2.0 Nxt Therapeutic Ultrasound Instruction Manual

VISSCO JUS 2.0 Nxt Therapeutic Ultrasound

Product Information

Product Name: JUS 2.0 Next
Model: Standard

Precautionary Instructions

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment.
The definitions of these symbols are as follows:

• CAUTION: Text with a CAUTION indicator will explain possible safety instructions that could have the potential to cause minor to moderate injury or damage to the equipment.
• WARNING: Text with a WARNING indicator will explain possible safety instructions that will potentially cause serious injury and equipment damage.
• DANGER: Text with a DANGER indicator will explain possible safety instructions that are Imminently hazardous situations that would result in death or serious injury.
• NO STEPPING ON SURFACE: Text with a NO STEPPING ON The SURFACE indicator will explain possible safety infractions that will cause equipment damage.

NOTE: Throughout this manual NOTE may be found. These NOTES are helpful information to aid in a particular area or function being described.

Nomenclature

The following are the symbols used in the manual and sticker:

• Hardware symbols:
  • IEC 60601 Medical Electrical Equipment Class TYPE BF
  • Electrical TYPE Class II Symbol
  • Ultrasound Applicator
  • DC Input Symbol
  • Output Indication
• JUS 2.0 NXT Instruction Manual

Warranty

For warranty information, please refer to page 14 of the instruction manual.

Product Usage Instructions

Instruction for the User

• Please read this instruction manual carefully before using JUS 2.0 NXT because it is unsafe to start using the device before reading the whole manual.
• The instructions on the following pages will show you how to use and care for your JUS 2.0 NXT in a general manner.
• You should be particularly familiar with the prescription and prescription information precautions before proceeding.

CAUTION:

• Follow the cautionary instructions provided in the manual to avoid potential safety risks.

Warnings:

• Pay attention to the warning instructions provided in the manual to prevent serious injury or equipment damage.

DANGER:

• Take extreme caution and follow the danger instructions provided in the manual to prevent any imminent hazardous situations that could result in death or serious injury.

Intended Use:

• The JUS 2.0 NXT is intended for the application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions.

Precautions:

When using the JUS 2.0 NXT, it is important to take the following precautions:

• Avoid using the device near sensitive areas such as the eyes or reproductive organs.
• Do not use the device on open wounds or broken skin.
• Ensure proper application of stimulation or electrical conductive medium to reduce irritation.

Potential for Burns:

• There is a risk of burns if the ultrasound therapy is not administered properly.
• Burns can occur due to high intensity (power), treating areas with sensory nerve damage, treating over bony prominences, or in desensitized areas.
• It is important to monitor the therapy and adjust the intensity as necessary to prevent burns.

Precautionary instructions

• The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment.
• The definitions of these symbols are as follows:
• CAUTION – Text with a” CAUTION” indicator will explain possible safety instructions that could have the potential to cause minor to moderate injury or damage to the equipment.
• WARNI NG – Text with a” WARNING” indicator will explain possible safety instructions that will potentially cause serious injury and equipment damage.
• DANGER- Text with a” DANGER” indicator will explain possible safety instructions that are Imminently hazardous situations that would result in death or serious injury.
• NO SITTING – Text with a” NO SITTING” indicator will explain possible safety instructions that will potentially cause serious injury and equipment damage.
• NO STEPPING ON SURFACE – Text with a “NO STEPPING ON SURFACE” indicator will explain possible safety infractions that will cause equipment damage.
• NOTE: Throughout this manual “NOTE” may be found. These NOTES are helpful information to aid in the particular area or function being described.
• NOMENCLATURE: The following are the symbols used in manual and sticker:

Hardware symbols:

INSTRUCTION FOR THE USER

• Please read this instruction manual carefully before using JUS 2.0 NXT because it is unsafe to start using the device before reading the whole manual.
• The instructions on the following pages will show you how to use and care for your JUS 2.0 NXT in a general manner. You should be particularly familiar with the prescription and prescription information precautions before proceeding.

CAUTION:

• USA Federal law restricts these devices to sale by, or on order of a physician or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner. DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner.
• DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner.
• Ultrasound should be routinely checked before each use to determine that all controls function normally, especially that the intensity control does properly adjust the intensity of the ultrasonic power output in a stable manner. Also, determine that the procedure tie control does actually terminate ultrasonic power output when the timer reaches zero.
• DO NOT use sharp objects such as pencil point or ballpoint pen to operate the buttons on the touch screen.
• This unit should be operated in temperature between +10°C to +40°C, transported and stored in temperature between -30°C to +60°C, with relative humidity ranges from 10% to 95%.
• Handle ultrasound applicator with care. Inappropriate handling of the applicator may adversely affect its characteristics.
• Before each use, inspect Ultrasound Applicator for cracks, which may allow the ingress of conductive fluid. Inspect applicator cables and associated connectors before each use.
• The JUS 2.0 NXT system is not designated to prevent the ingress of water liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient.

Warnings

• Do not use the Ultrasound for underwater treatments. The applicators are not watertight.
• Never operate the instrument at a level where the patient feels pain, and if you have any doubts about the proper level of dosage, select a lower amount
• When using, the applicator must be moved in a circular motion around the treatment site.
• Avoid unnecessary exposure to ultrasound (patient and therapist).
• The long-term effects of chronic electrical stimulation are unknown
• Use of controls or adjustments or performance of procedure other than those specified herein may result in hazardous exposure to ultrasonic energy.
• To prevent any electrical shock, disconnect the unit from the power source before attempting any maintenance procedures.
• Output current density is related to the applicator size. Inadequate applicator contact areas may result in patient injury. Please consult the enclosed manufacturer’s table for recommended applicators area to be used with the device. If any additional question arises regarding the applicator size, consult a licensed practitioner or the manufacturer prior to the therapy session.
• Stimulation should not be applied over the spinal cord area following laminectomy.
• Stimulation should not be applied over the neck and/or head including mouth and/or eyes. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to cause difficulty in breathing or close the airway.
• The device should not be applied on the anterior aspect of the chest (I.e. thorax)
• To be used under doctor’s prescription and control (not suggestion but obligation).
• To be used exclusively on not injured skin.
• To be used exclusively with adaptor from manufacturer.
• To be used exclusively with applicators from the manufacturer.
• Simultaneous connection of a PATIENT to an HF surgical EQUIPMENT may result in burns at the site.
• Do not modify this equipment without the authorization of the manufacturer.
• Before starting stimulation, the patient safety switch must be connected to the device and the patient must hold the switch.

DANGER

• Improper handling or use of this device may result in a high risk of death or serious injury.
• Patients with an implanted Neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy, microwave, diathermy, therapeutic, ultrasound diathermy, or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave ultrasound, and laser) can be transferred through the implanted Neurostimulation system, can be transferred through the implanted Neurostimulation system, can cause tissue damage, and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy even if the implanted Neurostimulation system is turned “off”.
• Handle clean, and dispose of components and accessories that have come in contact with bodily fluids according to National and local land Facility rules, regulations, and procedures.

INTENDED USE

• Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
• Pain relief
• Reduction of muscle spasm
• Joint contractures.

Precautions

• Some patients’ skin is more sensitive to ultrasound output. This can cause a reaction similar to a heat rash.
• Higher output levels have a greater potential for patient discomfort. Output power may be reduced by simply choosing a lower W/cm2 setting.
  Do not use ultrasound:

1. Over an area of the spinal cord following a laminectomy, i.e., when major covering tissues have been removed.
2. Over anesthetic area.
3. On patients with hemorrhagic diathesis.

• Caution should be used for patients with suspected or diagnosed heart problems.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Caution should be exercised in the presence of the following:
• When there is a tendency for hemorrhage following acute trauma or fracture.
• Following recent surgical procedures muscle contraction may disrupt the healing process.
• Over the menstruating or uterus.
• Over areas of the skin that lack normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium.
• The irritation can usually be reduced by using an alternate conductive medium or alternate applicator placement.

Potential for Burns

• It is possible for a patient to suffer a burn from ultrasound therapy if the therapy is not administered properly. Burns can occur for the following reasons:

1. Too high intensity (power).
2. Treating an area where sensory nerve damage is present with a loss of normal skin sensation.
3. Over bony prominences because they reflect sound waves and increase intensity to the periosteum.
4. Desensitized areas can be overheated or burned without the patient realizing it, so extreme care must be taken with these patients, e.g. on areas that are anesthetized.

• Burns can be avoided as long as the treatment causes no pain, tingling, excess heat, or aching (for patients with normal skin sensations).
• The gel pad is recommended to ensure a sufficient coupling agent. If liquid gel is used, make sure to place an ample amount between the applicator and the patient. Failure to do so may cause skin irritations or surface burns.

Adverse reaction:

• Skin irritation and burns beneath the applicator head have been reported with the use of powered muscle stimulators. Be aware that small applicator head areas and high output currents can cause burns; consult the table in the manual, ask a licensed practitioner if any question arises.
• Some patients may experience skin irritation or hypersensitivity due to the stimulation or electrical conductive medium. This irritation can usually be reduced by using an alternative conductive medium or any alternative electrode placement.

Contraindicated conditions:

• It is contraindicated to apply therapeutic ultrasound to patients with any of the following conditions:
• Pregnancy
• Acute and sub-acute thrombosis and thrombophlebitis
• Potentially Malignant lesions, tumors malignant or benign
• Areas or lumps that may be suspected as cancerous or precancerous
• Third degree musculotendinous lesions
• Cardiac pacemaker
• Implants of any electrical nature
• Skin diseases
• Multiple sclerosis
• Osteomyelitis
• Disturbances in cardiac rhythm
• Tissue or bone with acute sepsis
• Arteriosclerosis or weakened blood vessels
• Hemophilia
• Where sensory nerve damage is present with a loss of normal skin sensation.

Contraindicated Areas:

• It is contraindicated to apply ultrasound to any of the following areas:
• Transcerebrally
• To the eye
• To the ear
• Over a carotid sinus
• To the heart
• To major subcutaneous nerves and blood vessels
• To the spinal cord
• Around the bulbar area of the spinal cord
• To reproductive organs
• Over viscera (stomach, spleen, liver)
• Over or near epiphyseal areas of the bones in growing children, or adults until bone growth is complete
• Over stellate ganglion and subcutaneous major nerves
• To tissues previously treated by deep X-ray or other radiation
• Over the joint capsule in acute or sub-acute arthritic conditions
• Over ischemic tissue in patients with vascular disease
• Over a laminectomy site
• Over total joint replacements (the effect of ultrasound on new plastics is unknown)
• Over any internal metal
• Over a healing fracture

Instructions for applicator stand

Introduction

• JUS 2.0 NXT has been designated by engineers with years of expertise and knowledge in the medical device industry, specifically electrical stimulation. JUS 2.0 NXT is the result of extensive research in the area of Ultrasound technology.

DEVICE DESCRIPTION

• JUS 2.0 NXT is portable device with capacitive panel for user- interface. Device is based on ultrasonic energy which is used to treat human tissue. The energy is applied through a transducer head which consists of a crystal mounted at the front. The energy is applied to the part being treated through the transducer through a suitable coupling medium like conductive gel.
• JUS 2.0 NXT will have two outputs one for standard ultrasound. and another for HF, but one output will work at one time.
• There is a patient safety switch in this device which is operated by the patient in case of emergency. Once the patient operated this switch, machine will stop its operation immediately.
• Unit will be AC power supplied by external DC adapter.

Feature:

• Ultrasound Therapy.
• Touch Screen: simple one touch selection of stimulation programs.
• Dual applicator: Standard applicator.

THERAPEUTIC ULTRASOUND

WHAT IS THERAPEUTIC ULTRASOUND

• Therapeutic Ultrasound is a treatment modality utilizing sound waves to treat pain, inflammation, muscle spasm and joint contractures. Ultrasound therapy has been used by physical therapists since the mid-19th century.
• Therapeutic ultrasound is a unique form of penetrative energy. Ultrasound energy is not electrical, although electricity is used in its generation; it is not chemical energy, although it will accelerate chemical reactions; it is not radiation energy like x-ray or ultraviolet, for it will not penetrate a vacuum; and it is not thermal energy, although absorption of ultrasound in tissue produces heating.
• Ultrasound is a mechanical energy. It is a form of sound with a frequency beyond the maximum that can be detected by the human ear, i.e., above 20 kHz. These waves are not different from “normal” sounds in their physical properties, except that they have higher frequencies. The frequencies used in therapy are typically between 1.0 MHz and 3.0 MHz (1MHz = 1 million cycles per second).

HOW THERAPEUTIC ULTRASOUND WORKS

• Ultrasound waves are transmitted through soft tissues like nerves, muscles, and connective tissues with the help of a sound head or applicator crystal. This sound head must be constantly kept in motion to avoid undesirable effects.

Therapeutically, ultrasound has the following effects:

1. DEEP THERMAL EFFECTS: It is most prominently seen in dense collagenous tissues and requires relatively high-intensity waves in continuous mode to achieve this effect. Thermal effects cause increased blood flow to the localized area, increased tissue extensibility, and help to reduce local swelling and chronic inflammation. Increased blood flow delivers the necessary oxygen and nutrients and removes cell wastes.
2. NON-THERMAL EFFECTS (ACOUSTIC STREAMING):
   • Ultrasound introduces energy into the body. This energy causes microscopic gas bubbles around the tissues to expand and contract rapidly, a process called cavitation. It is theorized that the expansion and contraction of these bubbles help speed cellular processes and improve the healing of injured tissues.
   • Introducing ultrasound energy also causes acoustic streaming, which is described as the small-scale eddying of fluids near cell membranes and the surface of stable cavitation gas bubbles. This phenomenon is known to affect diffusion rates and membrane permeability. Sodium ion permeability is altered resulting in changes in the cell membrane potential. Calcium ion transport is modified which in turn leads to an alteration in the enzyme control mechanisms of various metabolic processes, especially concerning protein synthesis & cellular secretions.

ACCESSORIES

SPECIFICATIONS

SYSTEM SPECIFICATION

• Length: 286mm
• Width: 183mm
• Height: 63mm
• Net We i ght: Approx. 1.9 Kg
• Power Input: 24VDC 3.75A
• Electrical Class: CLASS II
• Relative humidity of Operating: 10% to 95%,
• non-condensing Non-Operating / Storage

Electrical type:

• Ultrasound: TYPE B
• Operating Temperatures: Between +10°C to +40°C
• Storage Temperatures: Between -30°C to +60°C

TECHNICAL SPECIFICATION

Standard Ultrasonic Generator Specifications

Specification

• Frequency: 1 MHz ± 10%; 3 MHz ± 10%;
• Modes: Continuous
• Pulsed: 10%, 20% and 50% Duty cycles;
• Modulation: 100%
• Modulation Waveform: Rectangular;
• Modulation   Frequency: 100Hz±5%;
• Temporal Peak/ average Intensity ratio: 10:1, 5:1, 2:1 ±5%;
• Maximum output power: 12.5 W with a 5 cm² applicator 1MHz, 10 W with a 5 cm² applicator 3MHz;
• Maximum intensity: 2,5 W/cm²;
• Amplitude: 0 to 2.5 W/cm² (in Continuous mode), 0 to 3 W/cm² (in Pulsed mode);
• Indication accuracy: ±20% (for any level above 10% of maximum);
• Head Warming: Yes;
• Contact Indication: Yes;
• Treatment Time: 5 – 30 Minutes;

Ultrasonic Applicator Specification

• 3 5/8″ sound head of 3 uniforms and harmonized crystals. Area of applicator 5cm2.

Individual Applicator Specification

CONTROLS AND FUNCTIONS

The front panel of JUS 2.0 NXT has the following functions which are explained as follows.

1. Standard: – Used to give the output for the treatment with the help of applicator lead wire.
2. Patient Switch: – There is a patient emergency stop switch which is connected to the device via cable to turn off the device immediately by a patient. When the Patient presses the Emergency Stop Button, the device will pause all stimulations (all started treatments) without any delay. The resume of treatments can be done only through the main user interface –it means that paused treatments cannot be resumed by Patient Switch, again you have to start the treatment by tapping on the start/stop option.
3. Adaptor Socket: It is used to connect the line cord to the grounded wall outlet.
4. Rocker Switch: – To start (ON) the device, press the rocker switch.
5. Select the ‘band of treatment’-
   •  1MHz
   • 3MHz
   • Select the ‘mode of treatment’-
   • Continuous
   • Pulsed
6. If ‘Pulsed mode’ is selected, set the parameters by pressing the ‘SETUP’ tab-
   • Frequency = 16Hz/ 48Hz/ 100Hz
   • Duty cycle = 10%/ 20%/ 50%
7. By pressing the up/down arrow keys, Adjust the parameters of treatment.
8. Start the treatment, by pressing the ‘START/STOP’ button
9. Set Time (Default 10 min – up to 30 min) and Intensity (Default 0 – up to 100%), After beginning the treatment.

Note:

Screen Lock: After 60 seconds of inactivity, the screen gets locked. To unlock, Long tap on any Icon for 3 seconds.

SCREEN DESCRIPTION

The front panel contains a couple of aspects:

• Capacitive touch on each function of the device as mentioned in the above figure;
• The backlight in each function indicates the device;
• Custom-designed LCD with backlight;
• Audio indication
• The front panel of JUS 2.0 NXT has the following functions which are explained as follows.
• Start/Stop – This option on the panel is provided to start or stop a particular treatment/Machine.
• Setup –This option is used to select or enter the following parameters of treatment: Frequency and duty cycle.
• Time Selection –This option is used for setting up the treatment time.
• Increment / Decrement(Up/Down): – These options are used for increasing or decreasing the following parameters: Frequency, Duty Cycle, Time, and Intensity.
• Mode : The user can use this option to change the frequency mode (Pulse/Continuous).
• Band Option : Select either 1 MHz or 3 MHz in standard ultrasound.

Note: When you are selecting any option (Frequency, Duty Cycle, Time, Intensity) two types of LED will shown

1. Blink: LED will blink when the particular function is in selection mode which you TAP.
2. Steady: LED will be steady when the particular function is selected which you TAP.

HOW TO OPERATE THE DEVICE?

1. Install the applicator stand on the right side of the device through a press fit.
2. Connect the applicator cable (Standard) back side of the device.
3. Connect the cable of the patient switch (Stereo switch) back side of the device.
4. Connect DC Adapter (24VDC, 3.75A).
5. Switch ON Device, Rocker Switch provided at the back panel.
6. Select the ‘band of treatment’-
   • 1MHz
   • 3MHz
7. Select the ‘Mode of treatment’-
   • Continuous
   • Pulsed
8. If ‘Pulsed mode’ is selected, set the parameters-
9. Frequency = 16Hz, 48Hz, 100Hz
10. Duty Cycle = 10%, 20%, 50%
11. Start the treatment, by pressing the ‘START/STOP’ button.
12. Set Time (Default 10 min – up to 30 min) and Intensity (Default 0-100%), After beginning the treatment.
13. DEVICE RUN TIME
    • The treatment time of ultrasound treatment is in the range of 5-30min, the default treatment time is 10min and the step in the process of defining the treatment time is 5 Seconds.
    • NOTE: The Treatment Time can be defined during the treatment.
14. DEVICE INTENSITY
    • The Intensity can be adjusted from 0-100% only during the treatment. In an idle state, it is.
    • The step in the process of defining the intensity is 1%.
15. Audio Indication
    • There is an audio indication provided through the buzzer, which beeps on below respective condition below.
    • Key pressed sound – The single “beep” effect
    • Error sound –Repeated 2 times beep;
    • Treatment time timeout indication – Long beep

DEVICE TREATMENT MODE

The device supported below treatment modes:

DEVICE TREATMENT MODE

ULTRASOUND

PATIENT PREPARATION

• It is important to properly prepare the patient’s skin for ultrasound therapy to ensure that most of the ultrasound energy reaches the targeted areas and the risk of skin irritation is reduced.
• Since every person’s tolerance to heat is different, the ultrasound intensity should be adjusted accordingly. The following steps must be followed to prepare the patient’s skin for ultrasound therapy:

1. The treatment area of the skin where the applicator sound head needs to be placed must be washed with mild soap and water.
2. After washing, the skin must be dried thoroughly.
3. A generous amount of conductive ultrasound gel must be applied to the treatment area on the patient as well as on the applicator sound head.

Fig. 10 Appling conductive gel

• The patient should not feel any heat during treatment. If the patient reports that the transducer feels hot on the skin surface, it is likely that the coupling medium is inadequate.
• If the patient reports a deep aching sensation during the treatment, stop immediately. Periosteal burns may feel like a deep ache while the ultrasound is still on, and only later in the day will feel intensely painful.

OPERATING STEPS ULTRASOUND Mode

1. First ON the device with the help of the Rocker switch.
2. Select the treatment Ultrasound by TAP on the ultrasound icon written on the device panel.
3. Select the band (1MHz or 3 MHz) and mode (Continuous or pulse) by tapping on the band icon or Mode icon and then tap on the increment and decrement icon.
4. Select the frequency (16, 48, and 100Hz) and duty cycle (10, 20, and 50%) by tapping on the SETUP icon indicated on the device. Single TAP on the SETUP icon, the frequency will blink inside the LCD which means your option is in a selection state.
   • Now select the frequency (16, 48, or 100Hz) by tapping the SETUP icon, the frequency will be steady inside the device which means that you selected the frequency. The same procedure for the duty cycle.
   • Note: Step 4 is applicable for Ultrasound treatment in Pulse mode, in continuous mode you cannot select the frequency and duty cycle.
5. Selects time and intensity by tapping on the time and intensity icon indicated on the device and choose the time (5 to 30) and intensity (0-100%) with the help of the increment and decrement icon.
6. After the above steps, tap on the start or stop icon, and your treatment will start.

STOPPING THE TREATMENT

There is a Start/Stop icon on the panel provided to start or stop a particular treatment.

Turning off the device

• Press the rocker switch to Switch OFF the device.
• Remove the adaptor’s pin from the DC input socket on the back side of the device.
• Disconnect the adaptor’s AC cord into a grounded wall outlet that has 110-220 V AC, 50/60 Hz.

TROUBLESHOOTING

Poor coupling or connectors

are poorly connected

| Check the applicator connection/ R
Uncomfortable stimulation or too strong stimulation| Lack of conductive gel| Stop the stimulation, put more conductive gel, and reposition the applicator on the treatment area.

Start treatment again.

Skin irritation at the applicator placement site| Improper contact/ Gel dried up| Remove the applicator from the treatment area for some time and

restart.

Sudden high intensity while increasing intensity level| Increasing too fast| Increase slowly giving time to patient to his/her comfort

MAINTENANCE

• Before any maintenance, switch the device off and unplug it from the mains! Observe all safety principles. Never dismantle the device and its accessories during cleaning!
• Do not repair the device. All servicing must be carried out by an authorized Johari Digital service center. Only original parts can be used for repair; otherwise Johari Digital bears no responsibility for further operation of the device.
• Before contacting your authorized Johari Digital service center, please get ready the device model number, serial number and a detailed description of the issue you have encountered.

Cleaning

• The device has to be always turned off by means of the mains switch when cleaning. The mains power switch has to be in OFF (“0”) position.
• Device must be cleaned thoroughly prior to usage to remove visible soil. To clean the device, use a soft cloth slightly moistened with water. Never use agents containing alcohol, chlorine, ammonia, acetone, benzene or thinners.
• Clean the touch screen gently by using a dry soft cloth. The cloth may be slightly moistened with a commercially available screen cleaner. Never apply the cleaner directly on the screen!Never use abrasive materials, otherwise the surface of the device or accessories could get damaged.
• Always turn the device off before disinfecting the applicator lead wires. Disinfectants must not reach the air vents.
• Clean the applicator lead wires after each use with disinfectants approved for use in medical environments. Do not use agents containing chlorine or those with a high alcohol content (more than 20%).
• Use a soft cloth slightly moistened with disinfectant. After disinfection, the accessories must be rinsed with a soft cloth slightly moistened with clean water so as to prevent an undesired allergic reaction!
• The device’s accessories are designed for non-invasive use; therefore, they do not need to be sterile and cannot be sterilized

Storage:

• Keep the device properly covered, when not in use to keep out of dust.
• Store the device in a proper and dry place. Damp environment cause rust and affect the functioning of device.

SUGGESTED APPLICATOR PLACEMENT CHART

Ultrasound with Combo

WARRANTY

• This product warranty extends to the original consumer/ purchaser of the product.

WARRANTY COVERAGE

• This product is warranted to be free from defects in materials and workmanship for a period of one (1) year. This warranty ceases if the product has been damaged by accident, in shipment, unreasonable use, misuse, neglect, improper service, repair by unauthorized personnel, or cause not arising out of defect in materials or workmanship. This warranty does not extend to any units that are used in violation of the guidelines set forth in this manual, or to units that have been altered or modified, or to damage to products or parts that have had the serial number removed, altered defaced, or rendered illegible.

WARRANTY DISCLAIMERS

• This warranty is in lieu of all warranties expressed or implied and no representative or person is authorized to assume for the manufacturer any other liability in connection with the sale of our products.
• There shall be no claims for defects or failure of performance or product failure/ any theory of tort, contract, or commercial law including, but not limited to negligence, gross negligence, strict liability, breach of warranty, and breach of contract. Some states do not allow the exclusion or limitation of implied warranties or consequential damages, so the above limitations may not apply to you.
• The manufacturer is not responsible or liable for indirect special or consequential damages arising out of or in connection with the use/performance of the product or other damage with respect to loss of property or loss of revenues or profit.

LEGAL REMEDIES

• This warranty gives you specific legal rights, and you may also have other rights that vary from state to state.

WARRANTY PERFORMANCE

• During the above one-year warranty period, a product with a defect will be repaired or replaced with a reconditioned comparable unit at the distributor’s option when the product is returned to the distributor.
• The repaired or replacement product will be in warranty for the balance of the one-year warranty period and an additional one-month period. No charge will be made for such repair or replacement.

CUSTOMER SERVICE

• For in-warranty service for a product covered under the warranty period, no charge is made for service and return postage. Please return the product insured, packed with sufficient protection, postage insurance, and prepaid to the address. The customer’s duty/brokerage fee, if any, must be paid by the consumer.

OUT-OF-WARRANTY SERVICE

• There will be charges rendered for repairs made to the product after the expiration of the one (1) year warranty period after the purchaser is advised appropriately.
• The distributor cannot assume responsibility for loss or damage during shipment. For your protection, carefully pack the product for shipment and insure it with the carrier.
• Ensure that you return the unit and accessories related to your problem and also that you indicate the full return address. Also, send a copy of the sales receipt or other proof of purchase to determine warranty status. C.O.D. shipments cannot be accepted.
• Please send the above warranty information and in the case of replacement of any accessory, to the following address:
• JOHARI DIGITAL HEALTHCARE LTD.
• G-582-584, EPIP, BORANADA, JODHPUR 342012 (RAJ.) INDIA TOLL FREE: 1800-102-8684
• Email:[email protected]
• www.joharidigital.com

List of Accessories: (In case of replacement or ordering)

A statement that the MANUFACTURER will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist SERVICE PERSONNEL to repair those parts of the EQUIPMENT that are designated by the MANUFACTURER as repairable by SERVICE PERSONNEL

• Marketed By VISSCO HEALTHCARE PVT LTD.
• 1208, Dalamal Tower, Free Press Journal Road, Nariman Point, Mumbai- 400021, India Tel.: +91-22-43330300/ 43330333
• Email: [email protected]
• www.vissco.com
• Manufactured By JOHARI DIGITAL HEALTHCARE LTD.
• G-582-584, EPIP, BORANADA, JODHPUR 342012 (RAJ.) INDIA
• TOLL FREE: 1800-102-8684
• Email: [email protected]
• www.joharidigital.com
• Dw# 52485204 Ver. 1.0.0 Date: 25 April 2023

References

• Medical Device Manufacturing Company - Johari Digital Healthcare Ltd
• Home - Vissco Healthcare Private Limited.

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