Zimmer Opton Скачать руководство пользователя страница 37 | Manualshive

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Safety checks
Metrological control

19

Page 29

For the device Opton neither a Safety check (STK) nor a Metrological Control
(MTK) is required in Germany.

In Germany, among others, the Medical Devices Operator Ordinance
(MPBetreibV) and the BG regulation to electrical systems and equipment (BGV

A3) apply in their current version.

Note:

These requirements apply to the operation of the unit in Germany. Please

observe the national regulations in your country.

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Содержание Opton

Страница 1: ...Instructions for Use Opton GB ...

Страница 2: ...e Fig 1 Selection and control elements 1 Controller unit 2 Display 3 Intensity controller Applicator with fiber optic cable 4 Applicator 5 Fiber optic cable Calibration sensor 6 Calibration sensor and holder for applicator 1 2 3 4 5 6 ...

Страница 3: ...Fig 2 Switches and sockets 7 Footswitch socket 8 Interlock connector socket 9 Socket for mains cable 10 Holder for main fuse 11 Identification plate 12 On off switch 13 Emergency stop button 14 Touch pen in holder 7 9 8 10 12 13 11 14 ...

Страница 4: ...Title bar 11 Navigation bar Fig 4 Navigation bar Description of the functions A Home Moves back to main page B Calibration Switches to the calibration page C Therapy Switches to treatment recommendations D Basic Program Switches to the base program 11 10 9 A B C D ...

Страница 5: ...Figures Accessories 14 Footswitch 15 Laser warning sign with laser warning lamp 16 Interlock plug 17 Protective sleeve 18 Laser protection glasses 19 Laser warning sign ...

Страница 6: ...k Type Applied BF part Footswitch socket Interlock socket Value of accessible fuses Instructions for use Follow the instructions for use Serial number Article number Manufacturer Date of manufacture Caution In the instructions for use this symbol indicates Caution with regard to possible damage to the device In this instructions for use this symbol indicates Danger ...

Страница 7: ...ications 1 2 Contraindications 2 3 Side effects 3 4 Safety instructions warnings 4 5 Application information 6 6 Opton in brief 9 7 Device set up 7 1 Safety precautions 7 2 Assembly and putting into service 10 11 8 Settings 12 9 Operation instructions 9 1 Performing treatments 9 2 Treatment recommendations 15 17 10 Calibration 19 11 Key code 20 ...

Страница 8: ...ional tests 29 19 Safety checks Metrological control 30 20 Error messages troubleshooting disposal 31 21 Manufacturer s EMC declaration 33 This instructions for use is valide for Opton devices and integral part of the device It must be stored with the device and kept accessable at all times for anyone authorized to operate the device This manual is valid as of October 2014 ...

Страница 9: ...ted Musculoskeletal disorders Healing pain relief Rheumatoid arthritis Symptom relief pain relief increased mobility Carpal tunnel syndrome Pain relief Tendinopathy Healing pain relief increased mobility Epicondylitis tennis elbow Healing Back and neck pain Pain relief Chronic joint diseases Pain relief Experience has also shown that Opton can have a positive effect in the treatment of the followi...

Страница 10: ...on in the abdomen or lower back Particular caution is adviced in applying treatments near the ear the nose mucous membranes and blood vessels Absolutely avoid direct irradiation of these areas In the presence of skin diseases metabolic disorders and or inflammatory diseases the treatment should be performed only after consulting a physician ...

Страница 11: ...Side effects 3 Page 3 When used correctly no side effects are known ...

Страница 12: ...ulations of the BG regulations applies only within Germany 1 Before first use the operation of the device must be reported to the professional association and the competent authority for occupational safety such as the trade supervision board 2 The operator must appoint a laser safety officer 3 The laser safety officer must provide safety instruction to all persons involved with the use of the dev...

Страница 13: ...other openings Take appropriate precautions 7 The fiber optic cable and applicator are very sensitive optical systems Treat them with appropriate care and protect them from contamination 8 Never bend the fiber optic cable and protect it against tensile loads Damage to the fiber optic cable can lead to unwanted radiation exposure 9 Do not unscrew the spacer sleeve on the front part of the applicato...

Страница 14: ...evice Please keep a safe distance of several metres Opton is not suitable for use in explosive flammable or combustive environment During use the device is to be located in a position allowing direct access to the device s central mains supply so that it can be disconnected from the mains at any time To avoid the risk of electric shock the device s mains plug must be disconnected from the mains su...

Страница 15: ...and adjusted The calibration sensor is also used for the applicator to be placed after treatment and when not in use This protects the applicator from dirt and damage Safety glasses All persons present in the treatment room patient therapist support staff should wear proper protective eyewear Only use goggles with an optical density OD 3 at 810nm and 980nm and a translucence of at least 20 in the ...

Страница 16: ... with a wide array of treatment options The modern microprocessor controls and the precise instrument for power measurement make the device easy to use at low risk use The modern clearly understandable colour display shows all parameters relative to the treatment and the modern touch screen controls provide fun and motivation during treatment Individual program start up settings and clear simple m...

Страница 17: ...ensure that all safety measures have been correctly followed The device should be protected against unauthorised use by activating the key button when not in use Note Make sure that the main switch on the device is set to 0 Ensure that all persons in the treatment room are wearing safety glasses Make sure that the applicator 4 is fully inserted into the calibration sensor 6 ...

Страница 18: ...on the key window will open automatically Enter the key code 1234 Note Each time the device is switched on via the main switch the key code must be entered Treatment screen Confirm the key code with OK this takes you directly to the treatment screen Setting the beam intensity Set the desired intensity with the intensity controller 3 Activate the laser Activate the laser by pressing Start Applicato...

Страница 19: ...ble from the start up screen Start up screen Note Selecting settings If no button is pressed within 4 seconds after turning on the device the key code screen automatically appears During this initial 4 seconds the user can also press the Start button 2 or press Settings 1 Pressing the Start button before the 4 seconds are up immediately opens the window for entering the key code If the home screen...

Страница 20: ...to return to the configuration menu 3 Audio and graphics settings Volume 1 Brightness Allows the screen brightness to be adjusted 2 Volume Allows the volume of the signal tones when touching the control panels to be adjusted The adjustment is made using the two arrow keys 5 OK Press the OK button to return to the start up screen 6 Version Press the Version button to open a window with information ...

Страница 21: ...ed each time the Opton is switched on 8 Default Press Default to restore the default factory settings Note The Maintenance menu is only accessible to service technicians Save settings Press OK to save the changed settings and return to the home screen ...

Страница 22: ...row buttons 2 Press the check mark 3 to accept the changed settings Press the X 4 to cancel the changes Operating modes The following operating modes can be selected no pulsing single pulse serial pulsing Available options in the various operating modes Single pulse Pulse time 0 5 5 seconds Frequency Duty cycle Serial pulsing 0 5 Hz 0 6 Hz 0 7 Hz 0 8 Hz 0 9 Hz 1 Hz 2 Hz 3 Hz 4 Hz 5 Hz 10 Hz 25 Hz ...

Страница 23: ...age switches to Active Note During use the patient must be monitored carefully and the treatment should be adjusted or terminated as necessary if any issues arise End treatment De activating the foot switch cuts off the laser beam The message in the footer switches from Active back to Ready The output must be manually reset to 0 0 W Use the controller to set the output level Note If output is term...

Страница 24: ...tment button in the navigation bar to open the Treatment Recommendations menu Selecting treatments by body region Select the body region by clicking on the black circles shown Selecting the body region After selecting the desired region of the body a window listing the recommended applications is displayed The selection is made directly by touching the corresponding row ...

Страница 25: ...nd of treatment and recommended amount of energy output The parameters for the pre defined programs can be individually modified and saved Note If the predefined program parameters in the treatment recommendations are changed the treatment recommendations are no longer valid The following message will appear Parameters have been changed no treatment recommendation possible ...

Страница 26: ... the bar graph in window 2 Calibration results The status bar 1 will display the calibration results 1 Calibration OK Laser is operating normally 2 Limited accuracy There is a deviation in the laser output This suggests contamination or age related changes to the laser system The device can continue to be used but maintenance should be performed within 4 weeks 3 Calibration failed The laser output...

Страница 27: ...ed each time the device is switched on Correctly entering the key code If an incorrect key code is entered this will be indicated by the following message After pressing OK you may attempt to enter the key code again Note In the configuration menu you can set your own key code ...

Страница 28: ...z 25 Hz 50 Hz CW mode Pulse duration 0 5 to 5 sec pulse mode Accuracy 20 Optional Optional Without spacers Small spacers Large spacers Treatment distance 0 cm 1 2 cm 4 5 cm Treatment area min Ø 10 mm 0 8 cm min Ø 20 mm 3 1 cm min Ø 34 mm 9 cm Output density max 5W cm max 1 3 W cm max 0 45W cm Dimensions 322 x 234 x 130 mm HxWxL Laser class 4 Safety distance NOHD Nominal Ocular Hazard Distance 2 2 ...

Страница 29: ...relative humidity no condensation Air pressure 700 to 1060 hPa Storage and transport Temperature 10 to 50 C Humidity 10 to 90 relative humidity no condensation Air pressure 500 to 1060 hPa Storage and transport Please keep all packaging The device may only be shipped and stored in the original packaging ...

Страница 30: ... until the dirt is removed Disinfection We recommend that disinfecting is to be carried out at least once a week as well as if there is any indication of contamination Please consult your hygiene professional in this regard Always clean the device prior to disinfection The housing foot switch and cables can be disinfected with disinfectant wipes Use a commercially available alcohol free disinfecta...

Страница 31: ...or lens Absolutely no residual cleaning or disinfectant agent must be left on the applicator lens Any contamination will change the optical properties of the lens Contact the service department in this case Caution If flammable solutions are used for cleaning and disinfection enough time must be allowed for them to evaporate before using the device Otherwise it may catch fire Note Only use the dev...

Страница 32: ...CE mark 14 Page 24 The product bears the CE marking according to EC Directive 93 42 EEC concerning medical devices ...

Страница 33: ...protective sleeves 2 touch pen 1 user manual see also accessories Accessories Article no 117 Mains cable 94062522 Foot switch 98072210 Door sensor 68072310 Interlock plug 87450240 Safety glasses 2 pcs 95730012 1 laser warning sign for door incl warning light 65730310 Protective sleeves 25 pcs 65071610 Silicone spacer 50400240 Small spacer 50400250 Large spacer 65800410 Touch pens 2 pcs 10102170 In...

Страница 34: ...combinations 16 Page 26 For Opton 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 35: ...ut only by persons authorised by Zimmer MedizinSysteme GmbH the user has ascertained the functional safety proper operating condition and mechanical integrity of device and applicator before use the device is operated only by properly trained personnel the device is not operated in hazardous areas and or a combustive atmosphere the device is immediately disconnected from the mains when penetrated ...

Страница 36: ... on 3 Enter the key code 4 Press the Calibration button 5 Activate the laser by pressing Start 6 Perform the calibration as described in Chapter 10 The message Calibration OK in the status line confirms that the laser unit is in good condition 7 Press the emergency stop button The appliance must switch off immediately Return the button to its original position by turning the knob in the direction ...

Страница 37: ...MTK is required in Germany In Germany among others the Medical Devices Operator Ordinance MPBetreibV and the BG regulation to electrical systems and equipment BGV A3 apply in their current version Note These requirements apply to the operation of the unit in Germany Please observe the national regulations in your country ...

Страница 38: ...customer service immediately Possible Cause 3 Emergency stop button pressed Remedy for cause 3 Check that the emergency stop button has been released Laser emits no power Possible cause 1 Interlock Remedy for cause 1 Check that the interlock plug has been correctly installed If a door sensor has been installed check whether the door is open or not closed properly Possible cause 2 Foot switch Remed...

Страница 39: ...ustomer service If there are frequent malfunctions or they cannot be resolved as described above inform customer service right away You can reach the service department via your sales representative or by calling our Neu Ulm office Headquarter Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 0 731 9761 0 Fax 49 0 731 9761 118 www zimmer de Disposal The device must be returne...

Страница 40: ...ironment specified below The customer or user of Opton should ensure that it is used in such an environment Emissions measurements Conformity Electromagnetic environment guidelines RF emissions per CISPR 11 Group 1 The Opton device uses RF energy only for its internal function Therefore its RF emissions are very low and it is unlikely that nearby electronic equipment will be impaired RF emissions ...

Страница 41: ... Mains power quality should be that of a typical commercial or hospital environment Surge voltages per IEC 61000 4 5 1 kV line to phase conductor 2 kV line to earth 1 kV line to phase conductor 2 kV line to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations per IEC 61000 4 11 5 UT 95 dip in UT for term 40...

Страница 42: ... to the transmittermanufacturer and d is the recommended separation distance in metres m The field strength of stationary radio transmitters measured on site for all frequenciesa should be less than the conformity level b In the vicinity of devices marked with the following symbol errors may occur NOTE 1 At 80 Hz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply ...

Страница 43: ...tter W Separation distance according to frequency of transmitter M 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 67 11 67 23 33 For transmitters whose maximum nominal output in the above table is not specified the recommended separation distance d in meters m can be determined using...

Страница 44: ...8 UR 1014 I Version 3 I Right of modification reserved Opton Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de Instructions for Use ...

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