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Manufacturer´s EMC declaration  

 

18 

 

 

 

 

Page 32 

 

 

 

With regards to the EMC (electromagnetic compatibility), medical electrical devices such 

- 

as the 

cl

Trac

 

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.

 

 

The cl

Trac

 may only be operated using the original power cable indicated in the scope of delivery list. 

Operating the device with another power cable can lead to increased emissions or reduced interference 

resistance of the device!

 

 

Guidelines and manufacturer declaration - electromagnetic emitted interference 

The cl

Trac

 device is intended for operation in an electromagnetic environment as indicated below. The cl

Trac

 

customer or user should ensure that it is operated in such an environment. 

Emitted interference 

Basic standard 

Compliance level 

Terminal Disturbance Voltage  

CISPR 11:2009 +A1:2010 

Class B, Group 1

 

Radiated Emissions  

CISPR 11:2009 +A1:2010 

Class B, Group 1

 

Harmonic emissions  

IEC 61000-3-2:2005 +A1:2008 +A2:2009  Class A

 

Voltage fluctuations / flicker emissions 

IEC 61000-3-3:2013

 

 

IEC 61000-4-15 for 10 
minutes  max 4%

 

 

 

The device must not be used directly next to or stacked on/under other 

devices. If operation near or stacked on/under other devices is necessary, the 
device should be observed to check for proper operation in this setup.

 

 

 

 

Содержание CITrac

Страница 1: ...Instructions for Use clTrac EN ...

Страница 2: ...device 1 Touch screen 2 Central control knob 3 Traction cord Fig 2 Rear of the device 4 Swivel head 5 Main switch 6 Power connector 7 Label clTrac 8 Jack plug Patient interrupt cable port 9 USB connector Firmware update port 10 Traction Cable 1 2 3 4 5 6 7 8 9 10 ...

Страница 3: ...Illustrations Accessories Fig 3 Fig 4 Patient interrupt button Mains cable ...

Страница 4: ...cal display of the settings Screen B Store button C Status bar D Parameter settings Fig 6 Displays Program E Switch to Programs Screen F Switch to Favorites G Switch to Manual H Switch to Settings I Back button J List of Indications D A E F G H B C I E J ...

Страница 5: ...nstructions for use this symbol indicates Caution with regard to possible damage of the device Applied part type B Operation instructions Follow instructions for use Protective earth ground Switch on switch off symbol Serial number Article number LOT Number Medical Product Manufacturer Date of manufacture Keep dry ISO 7000 0626 ...

Страница 6: ...perature 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 This product must not be disposed of with household waste ...

Страница 7: ...ns Displays Explanation of Symbols Page 1 Intended Use Indications Contra indications 1 1 1 1 2 Side Effects 3 1 1 2 3 Application Information 4 1 1 1 4 Warnings 5 1 1 1 5 clTrac in brief 6 1 1 2 6 Device Set Up 7 1 1 1 7 Settings 9 1 1 2 8 Operation Instructions 11 ...

Страница 8: ...ty Check Metrological Control 27 1 1 7 17 Error Messages Troubleshooting Disposal 28 18 Manufacturer s EMC declaration 32 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 It must be stored with the device and kept accessible at all times for anyone authorized to operate this device The instructions for...

Страница 9: ...ciatica and pain associated with Protruding discs Spinal root impingement Bulging discs Hypomobility Herniated discs Degenerative joint disease Degenerative disc disease Facet syndrome Posterior facet syndrome Compression fractures Acute facet problems Joint pain Radicular pain Discogenic pain Prolapsed discs Contra indications Traction therapy is contra indicated in patients with Structural disea...

Страница 10: ...lly with respect to the effects of the traction therapy Applied parts The patient interrupt button is a type B applied part The traction cord is intended to be attached to hip and thoracic traction harness belts that are sold and certified separately Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member Sta...

Страница 11: ...n 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 ...

Страница 12: ...ive flammable or combustive environment To avoid the risk of electric shock the device s main plug must be disconnected from the mains supply before performing any maintenance service or reprocessing activities 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...

Страница 13: ...cians therapists and health paraprofessionals It is imperative that these instructions are followed The patient must not be left unattended during therapy No modification of this equipment is allowed Only use specified products with the equipment Do not touch the patient while replacing the fuse The use in wet areas is not permitted and may in case of non compliance lead to considerable damage to ...

Страница 14: ...n surgical non invasive and non pharmaceutical treatment to relieve pain and correct spine problems What are other advantages of clTrac A large color display showing all therapy related parameters Modern touch operation as well as individual programmable parameters ensure maximum convenience for the user The integration of a patient interrupt button guarantees patient safety Notice The device is i...

Страница 15: ...late A Alignment hole with ø9 6mm 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 therapy table mounting bracket Hole A of the device fix on pin A of the installing plate only on specific traction tables available Turn...

Страница 16: ...ot work Notice The device may only be connected to sockets with protective earth Switch on the device Switch on the device with the power switch 5 Before switching on the device pull the traction cord 1 5 meter out of the clTrac If the traction cord shows any visible damage or the knot is deformed stop the treatment immediately and contact Zimmer MedizinSysteme GmbH or your local distributor Never...

Страница 17: ... default settings can be individually changed and adjusted Selecting configuration Pressing the Settings button A immediately switches to the configuration menu B Brightness Adjust the brightness by using the central control knob C Version Pressing the Version button opens a window with information about the current software version D Language Switch between the language E Start page Switch betwee...

Страница 18: ...n 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 ...

Страница 19: ...hen 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 The patient must never be left unattended during treatment Notice Prolonged wear on the cord can cause it to break which leads to sudden release of t...

Страница 20: ...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 screen Programs The user can start a treatment by using one of the 6 pre programmed programs Select the desired treatment program by pressing on the appropriate row After selecting on the Programs the treatment screen will pop up with accordingly pre set values 1 2 ...

Страница 21: ...reatment parameters change according to weight length strength etc Parameter screen Intermittent traction Parameters can be changed before starting a treatment To do this select the related parameter on the touch screen and change the parameter by using the central control knob 3 Pre Tension Force Force to which in this stage is built up 10N to 900N in steps of 1N Time Time for the pre tension pha...

Страница 22: ...wn Expressed in force second 5N s to 50N s in steps of 1N s Steps Number of steps 1 step to 10 steps in steps of 1 Hold Time Time between two steps in seconds 1s to 30s in steps of 1s Notice Parameter screen Static traction Force can be displayed in Pound Newton or Kilogram To change this see chapter 8 Settings Parameters can be changed before starting a treatment To do this select the related par...

Страница 23: ... displayed in the notification bar Notice The graphs shown on top of the screen during settings of the parameters are only meant as an indicative view of the selection Activation patient interrupt button Once the correct parameters are installed and the patient is connected press the patient interrupt button once It is strongly recommended to ask the patient to release the patient interrupt button...

Страница 24: ...atment See Pausing the therapy The treatment will be stopped The traction cord releases it s tension on a normal speed Shows the selected Program or Manual mode Shows in a graphical representation the course of the treatment The white line displays the expected force trajectory according to the set parameters The blue line shows the actual measured values Displays the minimum maximum and current u...

Страница 25: ...lecting the Resume button the traction cord will build up it s tension and the program will continue from the point of interruption Pausing the therapy Press the Pause button 15 to pause the therapy The device will go back to the parameter Settings screen After making changes in the Parameter Settings select Resume The treatment will continue from the point were the Pause button was pressed Notice...

Страница 26: ...tore button 20 to open the store screen and save the programmed treatment Put in a name for the program and press the Confirm button Now the program can be found on the Favorites screen Opening a Favorite Press the Favorite tab 21 in the taskbar on the right side of the screen to open the Favorites screen Selecting the treatment Select the desired treatment by pressing on the appropriate row 20 21...

Страница 27: ...n Instructions 8 Page 19 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 16 ...

Страница 28: ...t points Storage Transport Temperature 10 50 C Humidity 10 90 RH Air Pressure 700 1060 hPa Operation Temperature 10 25 C Humidity 20 80 RH Air Pressure 700 1060 hPa Use environment Indoor use only Professional healthcare facility environment except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging where the intensity of EM DISTURBANCES is...

Страница 29: ...nufacturer of the cleaning agent but not dripping wet Disinfection only manually Casing and patient button can be disinfected using disinfectant wipes Use a commercially available alcohol free disinfectant for metal and plastic with bactericidal veridical and fungicidal properties Observe the application instructions of the manufacturer Wipe all surfaces using a cloth soaked according to the speci...

Страница 30: ...CE Mark 11 Page 22 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 ...

Страница 31: ...r cable 2 0 m 54209140 1 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 o...

Страница 32: ...age 24 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 ...

Страница 33: ...l assist service personnel to repair those parts of the device that are designated by Zimmer MedizinSysteme GmbH as repairable by service personnel Basic safety Basic safety in the context of this document is defined as any situation that can occur that is harmful for the patient In order to achieve basic safety the clTrac has the following hardware safety measures Physical Max force motor 107 kg ...

Страница 34: ...e 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 ...

Страница 35: ...d 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 Notice These requirements apply to the operation of the device in Germany Divergent regulations may apply in your country ...

Страница 36: ... problem Open the cover of the supply socket and check the fuses If necessary replace the faulty fuse 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 Pop up Critical error occurr...

Страница 37: ...essed 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 Pop up Patient interrupt button is not present Possible cause 1 Patient interrupt button is not connected to the device Remedy for cause 1 Connect the interrupt button into the jack plug at the backside of t...

Страница 38: ...out of the device Remedy for cause 1 Release the rope and press the button on the screen The rope will be pulled completely into the device Notice The confirm button is only available when there is no tension on the rope Once the patient is released the confirm button is highlighted Notice If the rope is pulled during windup the pop up appears again Please let go of the rope to remedy and wait for...

Страница 39: ...otify technical support customer service of any problems that occur frequently or cannot be resolved You may get in touch with them via your sales representative or via the main office above 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 dis...

Страница 40: ...emissions or reduced interference resistance of the device Guidelines and manufacturer declaration electromagnetic emitted interference The clTrac device is intended for operation in an electromagnetic environment as indicated below The clTrac customer or user should ensure that it is operated in such an environment Emitted interference Basic standard Compliance level Terminal Disturbance Voltage ...

Страница 41: ...ostatic Discharge ESD IEC 61000 4 2 2008 8 kV contact discharge 15 kV air discharge Electrical fast transients bursts IEC 61000 4 4 2012 2 kV on AC mains port Surges IEC 61000 4 5 2005 1 kV line to line 2 kV line to protective earth Voltage dips and interruptions IEC 61000 4 11 2004 5 UT 95 drop in voltage for period 70 UT 30 drop in voltage for 25 30 cycles 5 UT 95 drop in voltage for 250 300 cyc...

Страница 42: ...28 V m FM 5Hz 1kHz sine Horizontal 5 sec 710 MHz 745 MHz 9 V m Pulse 217 Hz Horizontal 5 sec 780 MHz 810 MHz 870 MHz 28 V m Pulse 18 Hz Horizontal 5 sec 930 MHz 1720 MHz 1845 MHz 28 V m Pulse 217 Hz Horizontal 5 sec 1970 MHz 2450 MHz 28 V m Pulse 217 Hz Horizontal 5 sec 5240 MHz 5500 MHz 9 V m Pulse 217 Hz Horizontal 5 sec 5785 MHz 385 MHz 27 V m Pulse 18 Hz Vertical 5 sec 450 MHz 28 V m FM 5Hz 1k...

Страница 43: ...the location in which the clTrac device will be used exceeds the compliance level the clTrac device should be observed to verify proper functionality If unusual performance characteristics are observed additional measures may be required e g modified layout or a different location for the clTrac device Interference resistance tests IEC 60601 test level Compliance level Conducted disturbances induc...

Страница 44: ...ions for Use EN 10 105 118 I 0422 I Version 2 I Right of modification reserved 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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