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Zimmer CITrac Instructions For Use Manual

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Instructions for Use
clTrac
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Summary of Contents for Zimmer CITrac

  • Page 1 Instructions for Use clTrac...
  • Page 2 Illustrations Front and rear of the device Fig. 1 Front of the device Touch screen Central control knob Traction cord Fig. 2 4. Swivel head Rear of the device 5. Main switch 6. Power connector 7. Label clTrac 8. Jack plug (Patient interrupt cable port) 9.
  • Page 3 Illustrations Accessories Fig. 3 Patient interrupt button Fig. 4 Mains cable...
  • Page 4 Illustrations Screens Fig. 5 Displays / Therapy Graphical display of the settings Screen Store button Status bar Parameter settings Fig 6 Displays / Program Switch to Programs Screen Switch to Favorites Switch to Manual Switch to Settings Back button List of Indications...

  • Page 5: Explanation Of Symbols

    Explanation of Symbols In the instructions for use this symbol indicates “Danger” with regard to possible risks to people. In the instructions for use this symbol indicates "Caution" with regard to possible damage of the device. Applied part type B Operation instructions Follow instructions for use.
  • Page 6 Explanation of Symbols Fragile, handle with care Disposable packaging materials Keep away from sunlight, ISO 7000-0624 Temperature limit, ISO 7000-0632 Storage and Transport air humidity range Storage and Transport Air pressure range This way up CE mark including the number of the notified body. Disposal of electrical and electronic equipment as well as used batteries and accumulators.

  • Page 7: Table Of Contents

    Contents Illustrations Front / Rear of the Device Accessories Screens / Displays Explanation of Symbols Page Intended Use / Indications / Contra-indications 1.1.1. Side Effects 1.1.2. Application Information 1.1.1. Warnings 1.1.1. clTrac in brief 1.1.2. Device Set Up 1.1.1. Settings 1.1.2.
  • Page 8 Contents Technical Information Cleaning / Disinfection 1.1.3. CE-Mark 1.1.4. Scope of Delivery and Accessories 1.1.5. Device Combinations Safety and Maintenance 1.1.6. Functional Test Safety Check / Metrological Control 1.1.7. Error Messages / Troubleshooting / Disposal Manufacturer’s EMC declaration 1.1.8. Valid for TRA-01 devices. This device is further on in this manual called clTrac This instructions for use is an integral part of the device.

  • Page 9: Intended Use / Indications / Contra-Indications

    Intended use / Indications / Contra-indications Intended use The clTrac is a traction device for separating the cervical, thoracic or lumbar vertebrae along the inferosuperior axis of the spine by using a mechanical force. Indications Traction is indicated for general clinical use in case of musculoskeletal or neurological impairments of the spine.
  • Page 10 Intended use / Indications / Contra-indications Patient group / The intended patient group is children, young adults and adult patients considering intended population the contra indications and only when they are capable to express themselves orally with respect to the effects of the traction therapy Applied parts The patient interrupt button is a type B applied part.

  • Page 11: Side Effects

    Side Effects Side effects Spinal traction can cause minor muscle spasms. Direct after the treatment the patient can experience some dizziness. If traction belts are applied directly to bare skin, skin irritation may occur. Short after the treatment patients can experience some pain in the treated areas. Page 3...

  • Page 12: Application Information

    Inspect the device before to use. If there is any damage, it must not be used. Only a traction bank provided or recommended by Zimmer MedizinSysteme GmbH must be used. Only accessories provided or recommended by Zimmer MedizinSysteme GmbH must be used.

  • Page 13: Warnings

    Warnings User of the clTrac must be trained in how to use the device properly and have the appropriate skills. The device is intended to be used exclusively by medical professionals. The clTrac may not be used on patients who cannot express themselves orally with respect to the effects of the traction therapy.

  • Page 14: Cltrac In Brief

    clTrac in brief What is the clTrac The clTrac is a modern, innovative and easy to use traction unit that offers static and intermittent traction. What does the clTrac Spinal traction is a form of decompression that relieves pressure on the spine. What are the Traction is a non-surgical, non-invasive and non-pharmaceutical treatment to advantages of...

  • Page 15: Device Set Up

    B. Alignment set pin holes with ø6.5mm C. M8 Screw-holes for couch mount D. M8 Screw holes for stand mount or mounting bracket Only a traction bank provided or recommended by Zimmer MedizinSysteme GmbH must be used. Install device on...
  • Page 16 Improperly tied knots may result in injuries. Do not try to re-tie the knot unless you are properly trained. The used knot is the ‘double 8 loop knot’. If the traction cord needs to be replaced contact Zimmer MedizinSysteme GmbH or your local distributor The traction device and traction table must always be placed on level ground.

  • Page 17: Settings

    Settings Start-up screen Once the device has been switched on and the self-test performed, the start-up screen opens Standard screen After the self-test has been performed, clTrac goes automatically in the standard screen. In the settings menu, the factory default settings can be individually changed and adjusted.
  • Page 18 Settings (F) Units Switch between metric or imperial unit system. (G) Volume Adjust the volume by using the central control knob. (H) Set to default Pressing the ‘Set to default’ button restores the default factory settings. (I) Back Pressing the ‘Back’ button opens the previous screen. Page 10...

  • Page 19: Operation Instructions

    Before switching on the device, pull the traction cord 1,05 meter out of the clTrac. Inspect if the traction cord (3) has any visual damage. When damage is found the device needs service, please contact Zimmer MedizinSysteme GmbH or your local distributor. Inspection hand screws fixation device Before switching on the device, check the hand screws on the bottom of the clTrac if they are fixed.
  • Page 20 Operation Instructions Starting Switch on the device with the main switch (see Fig 2). Press the “Manual” button (1) to open the ‘Manual’ screen. Manual treatment or pre- programmed treatments can be selected from here. Opening a program Press the ‘Programs’ tab (2) in the taskbar on the right side of the screen to open the ‘Programs’...
  • Page 21 Operation Instructions The clTrac traction therapy has four different phases. Pre-Tension In this phase you can align patient and harness. Progression In this phase the clTrac builds up the tension forces toward the actual therapy. Traction In this phase the actual traction therapy takes place. Regression In this phase tension will be released.
  • Page 22 Operation Instructions Traction • Time: Total duration of this phase in minutes (1min to 99min in steps of 1min) • Max Force: Maximum force of this phase (15N to 900N in steps of 5N) • Min Force: Minimum force of this stage (10N to 895N in steps of 5N) •...
  • Page 23 Operation Instructions Progression • Speed: Speed at which the force is built up. Expressed in force/second (5N/s to 50N/s in steps of 1N/s) Traction • Time: Total duration of this phase in minutes (1min to 99min in steps of 1min) •...
  • Page 24 Operation Instructions (13) Current Force Shows the current force. Force can be displayed in P(ound), N(ewton) or K(ilogram). See chapter 8 Settings to adjust these. (14) Elapsed Time Shows the ellapsed time in minutes. (15) Pause Select the Pause button to pause the treatment. See ‘Pausing the therapy’. (16) Stop .The treatment will be stopped.
  • Page 25 Operation Instructions Patient interrupt button During treatment, the patient can use the patient interrupt button. By clicking on the patient interrupt button during a treatment a pop-up will show on the screen, accompanied by an acoustic signal. The treatment will be paused, the force will be reduced to 10N. By selecting the Stop button the treatment will stop and the Parameter screen will be showed.
  • Page 26 Operation Instructions Stopping the therapy Release the patient from the device by disconnecting the traction harness from the traction cord. Store a treatment To save a program, select the “Store” button (20) to open the store screen and save the programmed treatment.
  • Page 27 Operation Instructions Selecting parameters In the ‘Parameter’ screen, all steps of changing parameters; start; stop or pause a treatment are the same as in a program or manual treatment. For details see page 12 – Page 19...

  • Page 28: Technical Information

    Technical Information Power supply 110 – 240V Mains fuse 2x F2.5A 250VAC Protection class Applied class The patient interrupt button is a type B applied part. Dimensions 390 (W) x 300 (H) x 350 (D) Weight Approx. 14 kg Accuracy Applied forces have an accuracy of 10% with respect to their set points Storage/ Transport Temperature-10 –...

  • Page 29: 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 unplugged. Make sure that during cleaning and disinfection no liquids penetrate the device. Do not use sprays. If during cleaning or disinfecting liquid penetrates the device, please put the unit out of service, protect it from being used again and contact your service representative.

  • Page 30: Ce-Mark

    CE-Mark The product bears the CE-mark in accordance with the EC Directive on Medical Devices 93/42/EWG. Manufacturer Zimmer MedizinSysteme GmbH Junkerstraße 9 D-89231 Neu-Ulm Germany Page 22...

  • Page 31: Scope Of Delivery And Accessories

    54209140 Patient interrupt button (2.9 m)* Notice: The device may only be operated with original accessories from Zimmer MedizinSysteme GmbH. Otherwise, the function and safety, including EMC safety, of patients, users and other persons cannot be guaranteed. Notice * The EMC properties of the device and the accessories are not expected to deteriorate during the expected service life when the original manufacturer parts are used.

  • Page 32: Device Combinations

    Device Combinations Other than a traction table with connector, no combination devices are provided by the manufacturer. Anyone who contrary to these specifications combines devices and thus operates a medical system does so at its own risk. Page 24...

  • Page 33: Safety And Maintenance

    The device does not contain any parts that can be serviced or repaired by the operator. Zimmer MedizinSysteme GmbH 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 device that are designated by Zimmer MedizinSysteme GmbH as repairable by service personnel.

  • Page 34: Functional Test

    Functional Test Functional test The system performs a self-test and a self-calibration during start-up. Once these steps are completed, the system is operational. In event of a fault, an error message appears. There is no additional functional test that can be performed by the operator. Page 26...

  • Page 35: Safety Check Metrological Control

    Safety Check Metrological Control For the device clTrac neither a Safety Check (STK) nor a Metrological Control (MTK) is required in Germany. In Germany, the MPBetreibV (Medical Device Operator Ordinance) as well as the DGUV V3 (Accident prevention regulation – electrical systems and equipment), among others, apply in their respective current versions.

  • Page 36: Error Messages Troubleshooting Disposal

    Only replace the fuse with a replacement that has the same name / is an exact equivalent. Perform a complete check of the power supply for possible faults beforehand. If the fault persists, contact Zimmer MedizinSysteme GmbH or your local distributor for help Critical Error...
  • Page 37 Press patient interrupt button to proceed the treatment Possible cause 2: The patient interrupt button is pressed but does not work Remedy for cause 2: Replace the patient interrupt button or contact Zimmer MedizinSysteme GmbH or your local distributor for help. Patient interrupt button is not present...
  • Page 38 Error Messages Troubleshooting Disposal End of rope detection A pop-up appears notifying the user that they should release the rope and press the button on the screen. Possible cause 1: The rope is pulled completely out of the device. Remedy for cause 1: Release the rope and press the button on the screen.
  • Page 39 Disposal The device may only be returned to the factory in the original packaging. It must be disposed of by Zimmer MedizinSysteme GmbH. In foreign (European) countries, please refer to national regulations for disposal. Contact your distributor if necessary.

  • Page 40: Manufacturer's Emc Declaration

    Manufacturer´s EMC declaration With regards to the EMC (electromagnetic compatibility), medical electrical devices such as the clTrac are subject to special safety measures and must be installed and commissioned in accordance with the EMC instructions in the operating instructions or accompanying documents. The product fulfils the requirements of IEC 60601-1-2:2014 Portable and mobile RF communications equipment (e.g mobile telephones, cell phones) can impact medical electrical devices.
  • Page 41 Manufacturer´s EMC declaration Guidelines and manufacturer declaration - electromagnetic interference resistance The clTrac device is intended for operation in the electromagnetic environment indicated below. The clTrac customer or user should ensure that it is used in such an environment. Interference resistance Basic standard Compliance level tests...
  • Page 42 Manufacturer´s EMC declaration Guidelines and manufacturer declaration - electromagnetic interference resistance The clTrac device is intended for operation in the electromagnetic environment indicated below. The clTrac customer or user should ensure that it is used in such an environment. Interference resistance IEC 60601 test level Compliance tests...
  • Page 43 Manufacturer´s EMC declaration The field strength of stationary transmitters such as base stations for portable telephones and mobile land radios, wireless keyboard stations, AM and FM radios and televisions cannot be accurately theoretically predetermined. To determine the electromagnetic environment with regards to the stationary transmitters, a study of the electromagnetic phenomena of the location should be considered.
  • Page 44 Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 97 61-291 Fax +49 731. 97 61-299 export@zimmer.de www.zimmer.de...

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