Zimmer Micro 5 Instructions For Use Manual Download Page 1 | Manualshive

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Micro

5

EN

Instructions for use

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Summary of Contents for Micro 5

Page 1: ...Micro 5 EN Instructions for use ...

Page 2: ...igure Front of the device Fig overall view Radiator head cable Radiator head connection Adjustable radiator head Adjustment knob for radiation field Housing with vents Cruciform base with device rollers ...

Page 3: ...ront plate Power display Frequency display Treatment clock Operating display Mains connection display Display unpulsed Display pulsed Start stop button Operating mode button unpulsed pulsed Time setting Intensity controller Test lamp ...

Page 4: ...Figure Screens and display Fig rear Power inlet with mains connection switch and fuses Connection for radiator head cable Housing with vents ...

Page 5: ...n with regard to possible damage of the device Applied part B This symbol points out hazardous areas on the device This symbol warns of high voltage This symbol warns of non ionising radiation Prohibited for people with cardiac pacemakers Follow instructions for use Instructions for use Serial number Item number Manufacturer Date of manufacture ...

Page 6: ...1 Indications Contraindications Fehler Textmar ke nicht definiert 1 1 1 2 Side effects 3 1 1 2 3 Application information 4 1 1 1 4 Warnings 5 1 1 1 5 Micro 5 in brief 6 1 1 2 6 Device set up 7 1 1 1 7 Default settings 8 1 1 2 8 Operation instructions 9 9 Technical information 13 10 Cleaning Disinfection 14 1 1 3 ...

Page 7: ...ty check metrological check 20 1 1 7 17 Fault messages troubleshooting disposal 21 18 EMC declaration 22 1 1 8 Valid for the device Micro 5 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 The instructions for use are valid as of June 2019 ...

Page 8: ... in tissues e g pleural effusion ascites Febrile infectious conditions tuberculosis acute neuritis acute prostatitis Tumours metastases Individuals who are unconscious or not fully capable of responding infants Wet clothing and wet dressings Radiation must not be applied directly to metallic foreign bodies such as endoprostheses metal plates and metal discs These objects must therefore remain outs...

Page 9: ...Side effects 2 Page 3 Side effects of microwave treatment No side effects are known if used correctly ...

Page 10: ...t mechanical stress Caution Micro 5 is not suitable for use in areas with an explosive flammable or combustive atmosphere Caution 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 Caution To avoid the risk of electric shock the plug must be disconnected from the power supply bef...

Page 11: ...ch diathermy devices such as Micro 5 are used hearing aids and other electronic devices worn by the patient are removed before treatment The devices could be impeded in their action or suffer lasting damage the radiator head and its cable are handled with the necessary care Heavy blows and knocks can alter its targeting properties the device cannot be opened as this could make life threatening hig...

Page 12: ...gy into thermal energy directly in the tissues External heat application via the skin using heat packs for example does not allow such deep heating as the blood circulation would remove the heat before it reached its destination What are the benefits of Micro 5 Micro 5 is easy to use and its adjustable radiator head allows it to be used in various treatment situations What are the other benefits o...

Page 13: ... head There is a spring clip on the plug connection to the radiator head which secures the radiator head in place The radiator head can only be fitted or removed if this clip is taken off This allows the ring underneath the clip to be pulled back so that the radiator head can be inserted or removed Then replace the clip Connecting the device to a power supply Micro 5 may only be operated on a secu...

Page 14: ...he part Make sure that the radiator head setting is correct for the part of the body to be treated Follow the instructions for positioning the radiator head when doing this Press the start stop button Preselect unpulsed or pulsed treatment form and pulse frequency if applicable Preselect treatment time Start treatment by increasing the intensity control setting Comply with the dosage guidelines wh...

Page 15: ...owave power output in watts Low power operating mode is indicated by an L on the left If a fault occurs in the device an F appears in the power display followed by a fault number see chapter 13 The frequency display shows the pulse frequency selected in the case of pulse operating mode The treatment clock shows the preset treatment time and the time remaining to the end of treatment while treatmen...

Page 16: ...ause ratio 1 2 pulsed 1 Hz low power max 50 W pulse pause ratio 1 2 pulsed 0 5 Hz max 125 W pulse pause ratio 1 1 pulsed 1 Hz max 125 W pulse pause ratio 1 1 Adjustable radiator head Turning the adjustment knobs on the adjustable radiator head allows the operator to adjust the physical size of the radiation field to be adjusted to the requirements of the part of the body being treated The size of ...

Page 17: ...duce the following radiation fields Large field setting Circular field setting Half field left Half field right Dosage Dosage Increase the power only until the patient feels a sensation of heat that is still pleasant We do not recommend increasing the dose even if the sensation of heat declines during treatment Ask the patient how he she is feeling during treatment If the patient describes the hea...

Page 18: ...h as eyes and testes heat congestion Protection glasses special accessories must be used to protect the eyes when administering radiation to the head area Patients with cardiac pacemakers must not undergo microwave treatment The range of indications for which Micro 5 can be used is broader if the pulse operating mode option is selected The low level of energy conversion means that there are no hea...

Page 19: ...ng to EN 60601 1 Applied part Type B according to EN 60601 1 adjustable radiator head Environmental conditions Temperature 10 C 30 C Humidity 30 75 without condensation Air pressure 700hPa 1060hPa Storage and transport Temperature 0 C 50 C Humidity 10 90 without condensation Air pressure 700hPa 1060hPa only in original packaging Dimensions 33cm x 42cm x 72cm without radiator head and cruciform bas...

Page 20: ...agent but not dripping wet We recommend that disinfection is to be carried out at least once a week as well as if there is any indication of contamination Consult with your hygiene specialist when doing so Always perform cleaning prior to disinfection Housing and the adjustable radiator head can be disinfected using disinfectant wipes Use a commercially available alcohol free disinfectant for meta...

Page 21: ... The device has a 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 22: ...ustable radiator head adjustable for three radiation fields circular field half field large field Item no 98 470 400 Radiator head cable Item no 93 471 200 Radiator head arm Item no 118 Power cable 2 5 m Item no 32 470 040 Test lamp Item no 10 101 669 Instructions for use Accessories Item no 0010 Protection glasses ...

Page 23: ...nations 13 Page 17 For Micro 5 no combination devices are provided by the manufacturer Anyone who combines devices against these guidelines and thus creates a medical system does so under his her own responsibility ...

Page 24: ...r has confirmed the functional safety and the proper operating condition of the device 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 by liquid The device does not contain any parts that can be repaired by the operator Fuses and ot...

Page 25: ... building administration or technical management if necessary Interference can only be avoided by operating the device in isolation from other equipment in a screened room Place the adjustment knobs of the adjustable radiator head in the circular field position and switch on the device After switching on make sure that all the display elements are working correctly lights and LED figure displays a...

Page 26: ...ce Operator Ordinance MPBetreibV as well as the Regulation of the German Employer s Liability Insurance Association on electrical systems and equipment BGV A3 among others apply in their respective current versions Note These requirements apply to the operation of the device in the Federal Republic of Germany Please consider divergent national regulations in your country if applicable ...

Page 27: ...act customer service F 42 The device is about to overheat Switch off the device Then switch the device back on and wait for approximately 2 minutes without activating the intensity controller Operation should be possible again after this time If that does not resolve the matter contact customer service Other fault numbers Take the device out of service and contact customer service If any other pro...

Page 28: ...ectromagnetic environment as indicated below The customer or user of the Micro 5 should ensure that it is operated in such an environment Interference emission measurements Compliance Electromagnetic environment Guideline HF emissions according to CISPR 11 Group 2 The Micro 5 device must emit electromagnetic energy to guarantee its intended function Electronic devices in the vicinity may be impede...

Page 29: ...tal environment Surges according to IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode The quality of the supply voltage should correspond to that of a typical business or hospital environment Voltage dips brief interruptions and fluctuations in the supply voltage according to IEC 61000 4 11 5 UT 95 dip in the UT for cycle 40 UT 60 dip in the UT for 5 cyc...

Page 30: ...ecommended safety distance Conducted HF disturbances according to IEC 61000 4 6 3 VEffective value 150 KHz to 80 MHz 3 VEffective value 150 KHz to 80 MHz d 1 17 P Radiated HF disturbances according to IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 2 5 GHz d 1 17 P for 80 MHz to 800 MHz d 2 33 P for 800 MHz to 2 5 GHz with P as the rated output of the transmitter in watts w according to the ...

Page 31: ...romagnetic environment in which the HF disturbances are controlled The customer or user of the Micro 5 device can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunication devices transmitters and the Micro 5 device depending on the output power of the communication device as indicated below Rated output of the transmitter W Safety d...

Page 32: ...669 UR 0619 I Version 3 I Subject to changes Micro 5 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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