Zimmer PhySys Instructions For Use Manual
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Zimmer PhySys Instructions For Use Manual

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Instructions for Use
PhySys
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Summary of Contents for Zimmer PhySys

  • Page 1 Instructions for Use PhySys...
  • Page 3 Illustrations Front of the device / Ultrasound heads Fig. 1 Selection and operating Mains switch elements Intensity regulator channel I Display Intensity regulator channel II Fig. 2 Ultrasound heads 17 Ultrasound head, large, 5 cm² 18 Ultrasound head, small, 1 cm²...
  • Page 4 Illustrations Rear of the device Fig. 3 Ports Port for ultrasound head 0.8/2.4 MHz Port for patient cable channel II Socket for power cable Port for patient cable channel I Port for ultrasound head 0.8/2.4 MHz 10 Identification plate 11 USB connection...
  • Page 5 Illustrations Rear of the device / Screens and displays Fig. 4 Display views 12 Status line 13 Buttons on the screen 14 Buttons in the navigation menu 15 Buttons in the status line Fig. 5 Navigation menu / (A) Back Switches one page back or to the start-up screen Status bar (B) Therapy...
  • Page 6 Explanation of symbols In the instructions for use this symbol indicates “Caution”. In the instructions for use this symbol indicates "Attention" in order to avoid possible damage Attention of the device. Applied part type BF Electronic instructions for use available depending on the version Follow instructions for use Serial number Catalogue number...

  • Page 7: Table Of Contents

    1.4 Contraindications – Ultrasound therapy Side effects Application information 3.1 General 3.2 Electrotherapy 3.3 Ultrasound Warnings 4.1 General 4.2 Electrotherapy PhySys – in brief Intended use / Intended purpose Device set-up Configuration 8.1 General 8.2 Electrotherapy / ultrasound 8.3 Maintenance Operation instructions 9.1 Electrotherapy 9.2 Ultrasound therapy...
  • Page 8 Error messages / Troubleshooting / Disposal Manufacturer's EMC declaration Valid for the device PhySys. These instructions for use are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.

  • Page 9: Areas Of Application / Contraindications

    Areas of application / Contraindications 1.1 Areas of application – Electrotherapy Electrotherapy is used to promote circulation, to provide analgesia, to improve trophicity, to relieve muscle tension and to improve muscle tone. Other areas of application are musculoskeletal diseases, rehabilitation and wound healing. In addition, electrotherapy can be used for paralysis diagnostics.
  • Page 10 Areas of application / Contraindications 1.1 Areas of application – Electrotherapy Muscle weakness • Poor innervation of the skeletal muscles • Absent muscle sensation • Muscular overload • Painful muscle tension • Myofascial pain syndrome • Tendon and muscle ruptures •...

  • Page 11: Contraindications - Electrotherapy

    Areas of application / Contraindications 1.2 Contraindications - Electrotherapy General Unclear pain symptoms • Contraindications Acute inflammation (local, systemic) • (Suspected) cardiovascular diseases • (Suspected) epilepsy • Peripheral arterial occlusive disease, stage IIb or higher according to Fontaine • Purulent processes •...

  • Page 12: Areas Of Application - Ultrasound Therapy

    Areas of application / Contraindications 1.3 Areas of application – Ultrasound therapy Ultrasound therapy is used in orthopaedics, surgery, traumatology and rheumatology. Experiences from clinical practice have shown that there may be a positive effect when treating the following problems: Vertebrogenic pain syndrome, e.g.

  • Page 13: Contraindications - Ultrasound Therapy

    Areas of application / Contraindications 1.4 Contraindications - Ultrasound therapy General Unclear pain symptoms • Contraindications Diseases for which heat should not be used, such as acute inflammatory diseases • Diseases in which mechanical influences are contraindicated, such as phlebothrombosis •...

  • Page 14: Side Effects

    Side effects Side effects of If used as intended, no side effects are known. electrotherapy Side effects of ultrasound If used as intended, no side effects are known. therapy Page 6...

  • Page 15: Application Information

    If the electronic instructions for use are available in the device, there are no printed instructions Attention for use enclosed with the device. They can be accessed via the Zimmer website at www.zimmer.de/eIFU. The printed instructions for use can be requested from the manufacturer and ordered within 7 days by mail.

  • Page 16: Electrotherapy

    Application information 3.2 Electrotherapy Electrode positioning and the selection of treatment parameters should always be coordinated Attention to the treatment specifications. For currents for which there is a risk of chemical burns (for example, galvanic current, diadynamic currents, currents with a galvanic component), the recommended maximum Attention current density is 2 mA eff/cm²...

  • Page 17: Ultrasound

    Application information 3.3 Ultrasound Handle the ultrasound head gently; rough handling can alter its characteristics. Do not allow sharp or pointed objects to come into contact with the ultrasound head since the aluminium Attention head can be easily scratched. The use of coupling agents other than the special Sono plus ultrasound gel can damage the Attention ultrasound head.

  • Page 18: Warnings

    Warnings 4.1 General This device is intended to be used exclusively by medical professionals. It must always be ensured that two patients are never simultaneously connected to the device during a treatment session! The patient must not be left unattended during therapy. The person to be treated must be able to clearly communicate pain;...

  • Page 19: Electrotherapy

    Warnings 4.2 Electrotherapy Electrotherapy Placing electrodes near the chest can increase the risk of ventricular fibrillation. When performing iontophoresis, the drug used may have an analgesic effect and pain sensitivity is reduced as a result. Stimulation current can have a stimulating effect on insulin release. This may result in hypoglycaemia in diabetic patients.

  • Page 20: Physys - In Brief

    PhySys – in brief What are the features of A large colour display showing all therapy-related parameters, modern touch operation as well PhySys? as individual program start settings and a clear, simple menu navigation ensure maximum convenience for the user.

  • Page 21: Intended Use / Intended Purpose

    Intended use / Intended purpose Intended use PhySys is a combination device for therapeutic ultrasound and electrotherapy with the option of a vacuum unit for electrode application and supportive massage. Intended purpose PhySys is a medical combination device for the electro- and ultrasound therapy for the...

  • Page 22: Device Set-Up

    Note: The vacuum unit is integrated in the SysCart as a slide-in module. Please see the separate assembly instructions for securing the PhySys Edition SD desktop device to the SysCart and installing the vacuum unit in the SysCart. Vacuum unit Connect the red vacuum suction line to the provided port at the back of the SysCart at “circuit 1,...

  • Page 23: Configuration

    Configuration 8.1 General Note: The descriptions below always refer to therapy with one channel and are based on the factory settings. Note: Changes to the settings can only be made from the start-up screen. Note: All buttons, keys, menus and sub-menus can be activated directly on the screen with finger pressure.

  • Page 24: Electrotherapy / Ultrasound

    Configuration 8.2 Electrotherapy / Ultrasound Electrotherapy Activating the “Electrotherapy” button opens the “Configuration electrotherapy” screen. Frequency Option to adjust the basic frequency at the levels of 2500 Hz, 4000 Hz and 8000 Hz. The adjustment can be made using the two arrow buttons Therapy time Option to set a uniform therapy time for all programs.

  • Page 25: Maintenance

    This is used to backup or transfer therapy data. Import Favourites / By means of a USB stick, saved data can be transferred from another PhySys with a USB Memory / Diagnostics connection. In doing so, the newly saved data set replaces the data which were previously saved on the device.

  • Page 26: Operation Instructions

    Operation instructions 9.1 Electrotherapy General information: The following information applies for all forms of therapy available in the system: If the therapy times are individually extended, this may cause a change in the mode of action and the patient must be observed more closely during the application. Scrolling up and down in multipage lists is done by scrolling up and down in the screen.
  • Page 27 Operation instructions 9.1 Electrotherapy Description of the display elements and buttons (1) Status bar The status bar displays the name of the current therapy program. (2) Intensity / Start The bar graph displays the currently set intensity. In CC operating mode, this is displayed in mA or mA peak In CV operating mode, this is displayed in V...
  • Page 28 Operation instructions 9.1 Electrotherapy (7) Therapy time Displays the therapy time for the selected program. The pre-set therapy time can be extended or shortened using the “+”/”-” buttons. After the therapy has started, the therapy time currently remaining is shown. (8) Stop Activating the “Stop”...

  • Page 29: Ultrasound Therapy

    Operation instructions 9.2 Ultrasound therapy Program start Activating the “Programmes” button opens the “Programmes” screen. Select ultrasound therapy Activating the “Ultrasound therapy” button opens the “Programmes ultrasound therapy” screen. Select ultrasound therapy The desired ultrasound therapy program is selected directly in the corresponding line. program Treatment screen After the ultrasound therapy program has been selected, the therapy screen opens.
  • Page 30 Operation instructions 9.2 Ultrasound therapy Description of the display elements and buttons (1) Status line The status line displays the name of the current ultrasound program. (2) / (3) Intensity The bar graph displays (3) indicate the set intensity. Thermal effect / Micro The programs US 00, US 01, US 02 and US 09 emit the unpulsed ultrasound output and massage therefore exclusively have a thermal effect.
  • Page 31 Operation instructions 9.2 Ultrasound therapy (8) Start / Stop Activating the “Start” button starts the therapy and “Start” turns to “Stop”. Activating the “Stop” button interrupts the therapy and the intensity goes to 0.0 mA. To resume therapy, the intensity must be set once again and the “Start” button must be activated.

  • Page 32: Combined Therapy

    Operation instructions 9.3 Combined therapy Program start Activating the “Programmes” button opens the “Programmes” screen. Select combined therapy Activation of the “Combined therapy” button opens the “Programmes combined therapy” screen. Select combined therapy The desired combined therapy program is selected directly in the corresponding line. program Treatment screen After the combined therapy program has been selected, the therapy screen opens.

  • Page 33: Electrotherapy With Vacop / Vacop Solo

    Operation instructions 9.4 Electrotherapy with VacoP / VacoP solo Note: VacoP can be operated only in connection with the SysCart. If no VacoP is integrated in the SysCart, the “Vacuum” button is not shown. Note: If VacoP is operated in connection with electrotherapy, the “Vacuum” button must be activated from the “Electrotherapy”...
  • Page 34 Operation instructions 9.4 Electrotherapy with VacoP / VacoP solo Description of the display elements and buttons (1) Vacuum Activating the “Vacuum” button opens the “Vacuum” settings screen. Base vacuum: Using the arrow buttons, the base vacuum can be reduced to 12 kPa. If the base vacuum is set to more than 16 kPa, the working vacuum must be increased correspondingly.

  • Page 35: Information On The Operation Of Vacop

    Operation instructions 9.5 Information on the operation of VacoP The VacoP integrated in the SysCart contains a water separator which collects moisture emitted from the sponges and thus protects the vacuum unit from calcification. Note: Before you empty the water separator, remove any Vaco electrode from the tube. Emptying the water Empty the water separator by opening the discharge tap.

  • Page 36: Protocols

    Operation instructions 9.6 Protocols The “Protocols” menu provides support when selecting a therapy and makes a therapy recommendation. Protocols Activating the “Protocols” button opens the “Protocols” screen. Note: There are two options available for selecting the treatment recommendations: • Body region List •...

  • Page 37: Saving Programs

    Operation instructions 9.7 Saving programs Note: The programs can also be saved unchanged. The procedure for saving is the same for all forms of therapy. The procedure for saving an electrotherapy program is described below. The program parameters can be changed and saved in the therapy screen. Note: In addition to saving programs, the I/T curve data in the “Diagnostics”...

  • Page 38: Favourites/Memory List: Access Program, Edit List

    Operation instructions 9.8 Favourites/memory list Access programs, edit list The individually saved programs are listed in the Favourites and Memory list. Here these can be: retrieved for therapy or edited (moved in the sequence and deleted). Note: The steps to retrieve and edit the Favourites/Memory list are identical, so only the retrieving and editing the favourite list is described.

  • Page 39: Sequence Programs

    Operation instructions 9.9 Sequence programs Sequence programs are a compilation of up to three electrotherapy programs which are run consecutively in sequence. In the program family “currents for sports rehabilitation”, a variety of default programs are predefined. They generally comprise three phases: Warm-up, training or strengthening and relaxation.
  • Page 40 Operation instructions 9.10 Overview Paralysis diagnostics and therapy In PhySys special programs for the diagnosis and therapy of pareses and flaccid paralysis are available. Using the diagnosis programs, reference points for assessing the degree of severity of flaccid paralysis can be obtained and they enable the parameters needed for the treatment to be easily and individually determined.

  • Page 41: Technical Information

    Power consumption max. 60 VA VacoP Protection class Mains fuse 2 x T 2.0 A L, 250 VA (PhySys) 1 x T 0.2 A L, 250 VA (VacoP) Applied part Type BF Operating mode Interval operation- 30 minutes on, 10 minutes off...

  • Page 42: Stimulation Current

    Technical information 10.2 Stimulation current Emitted output(max.) At a load resistance of 500 Ohm Applied part Stimulation current electrodes Accuracy +20% Polarity of the currents If currents have a polarity: Red = positive (+), black = negative (-) Current form parameters Last Max.

  • Page 43: Ultrasound

    Technical information 10.3 Ultrasound Ultrasound heads Frequency 0.8 MHz and 2.4 MHz Ultrasound head, small 1 cm² , ERA = 0.67cm² at 0.8 MHz, 0.65 cm² at 2.4 MHz Maximum output 1.0 W at 0.8 MHz, 0.6 W at 2.4 MHz Intensity levels 0.1 to 1 W/cm²...

  • Page 44: Vacop

    Technical information 10.4 VacoP Vacuum 12 – 60 kPa Pulsed operation Period duration 1 to 8 s can be adjusted in intervals of 0.5 seconds; duty cycle 1: 1 Accuracy ± 20% Applied part Vacuum suction cups and sponges Page 36...

  • Page 45: Cleaning Disinfection

    Cleaning Disinfection – Before starting any maintenance and cleaning measures the device must always be switched off at the main switch and the mains cable must be disconnected. – Make sure that during cleaning or disinfection no liquid penetrates the device. Do not use sprays.
  • Page 46 Cleaning Disinfection Vaco-Electrodes Cleaning: In the event of visible contamination, the Vaco-Electrodes can be cleaned using commercially available alcohol-free plastic cleaners. Unplug the Vaco-Electrodes from the electrode tube and turn the suction cup completely inside out. Immerse the Vaco-Electrode in a cleaning solution according to the information from the manufacturer of the cleaning agent and clean the electrode thoroughly using a hard brush.

  • Page 47: Electrodes

    Disposable electrodes are particularly suitable for therapy with bipolar currents; for therapy with monopolar pulse currents or currents with a galvanic component, a moist sponge should additionally be used with the disposable electrodes as padding. All conventional electrotherapy electrodes can be connected to the PhySys using an insulated cable clip. Note: The disposable electrode is for one-time use only and can be disposed of with household waste without any problems.

  • Page 48: Ce Mark / Manufacturer

    CE mark / manufacturer The devices bear the CE mark in accordance with the EC directive on medical devices 93/42/EEC. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-0 Fax +49 731. 9761-118 www.zimmer.de Page 40...

  • Page 49: Scope Of Delivery And Accessories

    2 pairs Vaco electrodes, ø 90 mm, with sponges, self-closing 2 pairs Vaco electrodes, ø 60 mm, with sponges, self-closing Optional Scope of delivery PhySys SysCart Catalogue no.* 9161 1 SysCart with accessory tray * See following page for accessory article numbers...
  • Page 50 Swivelling base, rotatable 117* Power cable, angled, 3 m Electrotherapy Patient cable PhySys 1 pair electrode cables, grey, incl. 1 black and 1 red crocodile clamp 1 pair electrode cables, white, incl. 1 black and 1 red crocodile clamp Crocodile clip, red...
  • Page 51 Ultrasound head 0.8 and 2.4 MHz, white, ø 28 mm, SD edition 4200 Ultrasound head 0.8 and 2.4 MHz, grey, ø 13 mm, SD edition 4220 Ultrasound head holder PhySys table shelf 65801010 Sonogel, Sono Plus 0.5 L bottle VacoP...

  • Page 52: Device Combination

    Device combinations The device can be used in combination with VacoP. Anyone who combines devices against these guidelines and thus creates a medical system does so under his/her own responsibility. When combining devices, observe the specifications of standard IEC 60601-1, ed. 3.1. Page 44...

  • Page 53: Safety And Maintenance

    Device service may only be performed by trained staff. All descriptions required for service can be seen in the PhySys service manual or can be requested from the manufacturer. Upon request, Zimmer MedizinSysteme GmbH will provide wiring diagrams, lists of components, descriptions, calibration instructions or other documents.

  • Page 54: Functional Test

    Functional test After being switched on, PhySys performs a self-test which checks all internal components. If an error occurs, an error message will appear. In addition, an enhanced function test can be performed for all three operating modes. These tests should be performed monthly or if the proper functioning of the device is in doubt.

  • Page 55: Legal Notice

    Legal notice The PhySys device and the optionally available VacoP are listed in attachment 1 of the MPBetreibV (Medical Devices Operator Ordinance). Please observe the measures which are necessary as a result. The devices are not listed in attachment 2 of the MPBetreibV.
  • Page 56 Check the mains and socket; if necessary, have fault at mains or socket repaired by a professional (electrician). Possible cause 2: Mains fuse (PhySys) Remedy for cause 2: Check the mains fuse. Replace the fuse only with one with the exact same name/equal rating.

  • Page 57: Error Messages / Troubleshooting / Disposal

    You may get in touch with them via the sales representative or via the main office in Neu-Ulm. The device may only be returned to the factory in its original packaging. Headquarter Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel.

  • Page 58: Manufacturer's Emc Declaration

    The tested frequencies are listed in Table 4. The PhySys device does not contain any components which can age during the life of the device or which can lead to worsening of the electromagnetic compatibility. Thus, no maintenance is necessary during the service life of the device to ensure basic safety.
  • Page 59 Guidelines and manufacturer's declaration – Electromagnetic immunity The PhySys device is intended to be operated in the electromagnetic environment as indicated below. The customer or user of the PhySys device should ensure that it is used in such an environment.
  • Page 60 If the measured field strength in the location in which the PhySys device is used exceeds the above compliance level, the PhySys device must be observed to verify normal operation.
  • Page 61 Manufacturer's EMC declaration Recommended safety distances between portable and mobile HF telecommunication devices and the PhySys device Test frequency (MHz) Band (MHz) Service Modulation Max. energy Distance (m) Immunity test level (V/m) 380-390 TETRA 400 Pulse modulation 18 Hz 430-470...
  • Page 64 PhySys Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Deutschland Tel. 07 31. 97 61-0 Fax 07 31. 97 61-118 info@zimmer.de www.zimmer.de Export Department: Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de...

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