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INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE
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INSTRUCTIONS FOR USE

Product catalog summary
Specified Purpose of Use
The VAS-07 Edition "Better Future", Version BASIC, is designed for non-contact electrotherapy using low and mid-frequency currents to alleviate pain and promote healing in musculoskeletal tissues. This method, known as Distant Electrotherapy (DET), does not require direct contact with electrodes.
Indications
The device is indicated for treating painful musculoskeletal conditions, degenerative disorders, post-injury recovery, peripheral blood flow disorders, nerve regeneration, osteoporosis, bone necrosis, fracture healing, and certain skin diseases.
Contraindications
Contraindications include patients with implanted electrical devices, serious medical conditions, pregnancy, cancer, severe ischemic diseases, heart disorders, metal implants, sensitivity disorders, neurological disorders, thrombosis, menstruation, and other specific medical conditions.
Target User Group
The device is intended for adult patients aged 18 and older, to be operated by trained medical personnel under professional supervision.
Method of Application
The device uses eddy currents generated by electromagnetic induction for therapeutic effects. It offers pulsed and interference currents, with treatment times varying based on the condition being treated. The choice of current type is determined by a qualified physician.
Safety Warnings
Users must adhere to safety guidelines to prevent adverse effects, especially considering contraindications and potential side effects.
Technical Characteristics
The device includes components such as a stand, intelligent unit, applicator, and requires specific area requirements for operation. It features detailed technical specifications and labeling.
Maintenance
Regular cleaning, checks, and maintenance are required to ensure device functionality and safety.
Packaging, Disposal, and Storage
Instructions are provided for proper packaging, disposal, and storage to maintain device integrity and compliance with environmental conditions.
EMC Information
Electromagnetic compatibility measures are outlined to ensure safe operation in various environments.
Device Overview and Installation
The VAS-07 Edition "Better Future" Version BASIC is a therapeutic device designed for various medical applications. It comes fully assembled and requires careful unpacking to avoid damage. Essential components include user documentation and other agreed materials. The device is mobile, equipped with wheels, and should be placed in a stable position before use. The applicator cable must be securely connected, and the device should be plugged into a properly fused 230V/50Hz AC power supply.
Operating Instructions
Before operation, the user manual must be thoroughly read. The device features a rotating applicator arm that should not exceed marked angles. The operator should maintain a safe distance from the applicator during procedures, as specified by ICNIRP guidelines. The device is operated via a control panel, with options navigated using designated buttons.
Treatment Programs
The device offers various treatment programs categorized by indication groups, such as vertebral diseases, degenerative diseases, and more. Each group provides specific diagnoses that can be treated using the device. Treatment involves selecting pulse or interference currents, each with distinct parameters like frequency and duration.
Safety and Adjustments
Adjustments to the applicator's position are made using ball bushings and locking levers. The device's operation mode requires careful handling to ensure safety, especially due to the high voltages involved. The device's display provides detailed descriptions of selected treatment currents, with some parameters adjustable by the user.
Conclusion
The VAS-07 Edition "Better Future" Version BASIC is a sophisticated medical device requiring careful handling and adherence to safety protocols. Its various treatment programs and adjustable parameters make it versatile for different medical conditions.
Device Safety and Handling Instructions
The VAS-07 Edition "Better Future" Version BASIC must be immediately turned off and disconnected from the power supply if it malfunctions or is exposed to non-standard conditions. It should not be used under inadequate power supply conditions and must be placed in a stable position to prevent falls. Only authorized personnel should remove the device covers, and modifications are prohibited. Ventilation openings must remain uncovered, and the device should be disconnected from power before cleaning.
Environmental Considerations
The device should not be used in environments with increased risk of electric shock, explosive atmospheres, or high fire risk. It must be kept dry and free from foreign objects and liquids.
Therapy Application Guidelines
Electrotherapy procedures affecting the abdominal area should be applied to women only during the first half of the menstrual cycle. Operators and others must maintain a safe distance from the applicator during operation. The device emits modulated red light, which may cause health issues in sensitive individuals. Skin contact with the device should be safe, and operators must avoid touching the applicator during operation.
Operator Training and Patient Education
The device requires a responsible user and a trained operator. Patients may be left under remote supervision if their health permits, otherwise, they must be monitored by a healthcare professional.
Cleaning Instructions
The device must be turned off and unplugged before cleaning.
Adverse Event Possibilities
Potential risks include increased metabolic activity, sudden blood pressure drops, and interactions with certain medications. A transient increase in pain may occur initially, which usually subsides with continued treatment.
Technical Characteristics
The device is manufactured by EMBITRON s.r.o., Czech Republic. It consists of a mobile stand, intelligent device unit, and a movable applicator. The device operates on a 230 V, 50 Hz power supply and is classified as a medical device class IIa. It complies with various electrotechnical standards and is not intended for sterilization.
Specifications
The device operates with a 315 mA slow breaker switch and produces magnetic induction through an applicator at 100% intensity. It generates interferential currents with a peak value of 1 mT and pulse currents with a peak value of 2 mT. The electrical voltage and induction current in tissue at 100% intensity are specified for both interferential and pulse currents. The device supports pulsed induced electric currents with a pulse width of 150 µs or 340 µs and operates at frequencies ranging from 1 to 3,123 Hz. The light flux is produced by 40 LEDs with a wavelength of 660 nm and a luminance of 1,000 mcd.
Device Construction
The device weighs 14.5 kg gross and 12.5 kg net, with dimensions of 1300 x 450 x 500 mm when unpacked. It is constructed with ABS plastic housing and stainless steel surfaces.
Labeling and Symbols
The device label includes symbols for BF applied part, manufacturer identification, moisture protection, and disposal instructions. It also indicates temperature and humidity limits.
Maintenance
Regular cleaning, washing, and disinfection are required, using specified detergents and disinfectants. Routine checks of device integrity and functionality are necessary, with annual inspections mandated by the manufacturer.
Packaging
The device is packaged in a carton box with EPS boards and wooden slats for reinforcement. It is wrapped in stretch film and labeled with safety symbols.
Disposal
The device must be disposed of as waste electrical and electronic equipment, coordinated by the manufacturer.
Storage and Transport
The device should be stored and transported in environments with temperatures between +5 °C and +40 °C and humidity between 5% and 85%. It must be handled as a fragile item.
Environmental Conditions
Operating conditions include temperatures from +10 °C to +25 °C, humidity up to 80%, and pressure between 700 hPa and 1,060 hPa. The device should be placed away from sensitive electronics and flammable substances.
EMC Information
The device complies with EMC standards and should be placed at least 1 meter away from other devices emitting magnetic or electric fields. Specific warnings are provided regarding the use of accessories and RF communication equipment.
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Catalog excerpts

INSTRUCTIONS FOR USE-1

ELECTROMEDICAL EQUIPMENT User’s manual

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INSTRUCTIONS FOR USE-2

Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-3

The purpose of the device VAS-07 edition „Better Future“, Version BASIC, is to provide induced low frequency pulses and mid-frequency interference electrotherapy currents without the need to apply contact electrodes to the patient’s body in order to have a positive therapeutic effect on painful conditions and to promote healing, regeneration or repair of musculoskeletal tissues. The relevant physical and therapeutic procedures are referred to in the medical literature as Distant Electrotherapy (DET). Fig. 1.1. VAS-07 edition „Better Future“, Version BASIC 3 Instructions for use / User‘s manual...

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• Supportive physical therapy in the treatment of algic (painful) conditions of the musculoskeletal system, • in degenerative musculoskeletal disorders, distance electrotherapy is used to relieve pain and promote regeneration, • in the treatment of post-injury conditions, distance electrotherapy is used to relieve pain and promote healing, • supportive treatment of peripheral blood flow disorders of various aetiologies, • to promote regeneration of damaged peripheral nerve axons, • supportive treatment of osteoporosis, treatment of aseptic bone necrosis and fracture healing, • supportive treatment...

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Target user group Target patient group: The target patient group is adult patients, men and women aged 18 years and older. The method is applicable to all ethnic groups with regards to the method of application and mechanism of action. User profile: The user is Physician or trained medical personnel. The application is expected to be supervised by a trained health professional. The DET method used implies the need for the device to be operated exclusively by a trained person who has been trained by a person authorized to provide training in the operation of the device. 5.1 Mechanism of action...

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associated side effects (e.g., slightly increased soreness during the first application or the first few applications) may also be more pronounced. Relative contraindications (e.g., the possibility of heating of the endoprosthesis material) should also be more carefully considered when applying interference currents. However, even pulsed currents can be so effective in many cases that they can outperform the generally more radical interferential currents, especially if they are currents close to the TENS type for pain relief on the basis of the gatekeeper theory or on the basis of stimulation...

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INSTRUCTIONS FOR USE-7

Vertebrogenic disease: Degenerative disease: Morhi vertebrogenae Morbi degenerationae Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-8

Blood circulation disorders: Morbi inflammationae Morbi vascularae et lymphae Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-9

Bone disease: Traumas and their consequences: Morbi osteae Algodystrophic syndrom - lower limb Tmumae et suae sequelae Analgia - Analgesia Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-10

Diseases of muscles and relevant nerves: Traumae et suae sequelae Analgia - Analgesia Enthesopathy and other diagnoses/indications: Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-11

Localization 2: sacroiliac joint Analgia - Analgesia Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Analgia - Analgesia Musculus abbreviatus Musculus scissus Striae Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Localization 5: upper back LOCALISATIO 5 Frozen shoulder_ Qmarthrosis - omalgia_ Periarthritis humeroscapularis Sanatio postoperativa_ Sanatio posttraumatica_ Acupuncture contactless stimulation of the needles Distensio muscularis_ Hypertonia musculorum_ Post - poliomyelitis syndrom_ Spasticis - myospasmus_ Triger points profundus (deep)_ Trigger points superficial^_ Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Localization 7: anterior knee Arthrosis acuta exacerbans Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-15

Localization 10: lateral knee Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-16

Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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INSTRUCTIONS FOR USE-17

Algodystrophic syndrom - upper limb Fractura_ Paresis nervi muse._ Regenerate nervi periferi_ Tendinitis acuta_ Tendinitis chronica_ Tendovaginitis acuta_ Tendovaginitis chronica_ Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Analgia - Analgesia Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Localization 18: foot distally Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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Acupuncture contactless stimulation of the needles For each diagnosis or indication, 1 to 3 therapeutic pulsed electric currents and 1 to 3 therapeutic interference electric currents are available. Instructions for use / User's manual • VAS-07 Edition „Better Future“ Version BASIC rev.2201

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VAS-07 Edition „Better Future“ Version BASIC is very easy to install, as the entire device is supplied fully assembled for the general customer. The device is only removed from the transport box. Before removing the device from the crate, it is advisable to first remove the protective padding or to place the transport crate in such a way that the entire device can be carefully slid out of the crate without damaging it and without destroying the transport crate. Care should be taken to ensure that the other essential components of the device are also removed from the transport box, including:...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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