Zimmer enShock Instructions For Use Manual Download Page 29 | Manualshive

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Zimmer enShock Instructions For Use Manual Download Page 29

CE marking

10

Page 19

The device bears the CE marking

0123

Accords with the EC Directive on Medical Devices 93/42/EEC and meets the
essential requirements of Appendix I of this directive.

The device is classified in class IIa according to Appendix IX of the directive.

Manufacturer

Zimmer MedizinSysteme GmbH

Junkersstraße 9
89231 Neu-Ulm, Germany

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Summary of Contents for enShock

Page 1: ...Instructions for Use enShock EN ...

Page 2: ...Figures Front of the device Fig 1 1 Handpiece connector 2 Display 3 Central control knob 2 3 1 ...

Page 3: ...Figures Rear of the device Fig 2 Switches and 4 Foot switch connector connection ports 5 Earth connector 6 Speaker 7 Air vent 8 Fuse holder 9 Connection for power cable 10 On off switch 5 4 6 10 9 7 8 ...

Page 4: ...reens display Fig 3 11 Indicator for the adjusted energy 12 Start stop button 13 Store button 14 Switches to Protocols 15 Switches to Favourites 16 Switches to Therapy 17 Switches to Settings 13 11 14 15 16 12 17 ...

Page 5: ...Figures Accessories Fig 4 Handpiece 18 Gel pad fixation ring 19 Therapy activation button Gel pads 5 10 15 20 25 30 35 40 mm Foot switch optional Conductive gel Power cable ...

Page 6: ...ions for use this symbol indicates Caution with regard to possible damage to the device Products which are marked with the adjacent symbol may not be disposed of in household waste The European WEEE Directive applies here Note the instructions for use Follow the instructions for use Switch on switch off symbol Serial number Lot number Article number Manufacturer Date of manufacture ...

Page 7: ...king with the number of the notified body Medical device Protect from heat sunlight Storage and transport temperature range Storage and transport air humidity range Storage and transport air pressure range This side up indicates top side of the packaging Fragile handle with care Protect from moisture Recyclable ...

Page 8: ...Explanation of symbols Unique Device Identification Maximum stacking height ...

Page 9: ...traindications and side effects 1 2 Application information 3 3 Warnings 5 4 enShock in brief 6 5 System set up 7 6 Settings 8 7 Operation instructions 7 1 Application recommendations 7 2 Performing the treatment 7 3 Displays and buttons 7 4 Protocols 7 5 Favourites 9 10 11 13 14 8 Technical information 15 9 Reprocessing Cleaning disinfection 16 10 CE marking 19 ...

Page 10: ...15 Safety checks metrological checks 25 16 Error messages troubleshooting disposal 26 17 EMC declaration 28 Valid for the device enShock 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 May 2021 ...

Page 11: ... pain syndrome Lateral epicondylitis lateral epicondylopathy of the elbow tennis elbow mouse elbow mouse arm medial epicondylitis golfer s elbow Patella tip syndrome jumper s knee patellar tendinopathy Achilles tendinopathy Plantar fasciopathy and plantar fasciitis Pseudoarthrosis and bone non union delayed union and its causes osteochondritis dissecans and its causes avascular necrosis femoral he...

Page 12: ...ccurring post treatment Vascular injury Exacerbation of the condition Worsening symptoms Local soft tissue damage Absence of bony connection in the case of stress fractures Pseudathrosis Intended user enShock is intended for health care professionals such as physiotherapists doctors and medical assistants Target patient population enShock should not be used on infants and young children enShock sh...

Page 13: ...special precautionary measures with regard to electromagnetic compatibility EMC and must be installed according to the EMC information in the accompanying documentation For more information see chapter 17 Manufacturer s EMC declaration Operation of this device in the vicinity of strong electromagnetic fields e g tomographs X ray or diathermy equipment may interfere with its operation Please keep a...

Page 14: ...ds if they are mechanically damaged or if the consistency has noticeably changed The gel pads should be replaced after one year of use at the latest Remove any excess conductive gel from the gel pads and applicator immediately after therapy has ended The applied parts may only come into contact with the patient s uninjured skin Only use the conductive gel that is provided for this purpose and incl...

Page 15: ...rts which contain metal implants for example a bone nail pacemaker ICD IUD etc must be excluded from the treatment Cables leading to the applicator should be guided in such a way that contact with the patient or with conductive or energy absorbing objects is avoided Ensure that the handpiece and gel pad are never directed towards the eyes during operation Ensure that the handpiece and gel pad are ...

Page 16: ...k The modern clear colour display shows all therapy related parameters and offers modern touchscreen operation combined with the optional foot switch this ensures motivation on the part of the user and efficient patient treatment The compact design enables space saving work in an office and is ideally suited for mobile use The low noise handpiece guarantees no disruptive side effects for the pract...

Page 17: ...before therapy Rotate the gel pad fixation ring 18 anti clockwise to remove it Select a gel pad and apply sufficient conductive gel to the back side of the pad Place the back side of the gel pad into the handpiece and put the gel pad fixation ring 18 back on the handpiece Fix the gel pad fixation ring 18 in place by rotating it clockwise Make sure to use sufficient conductive gel on the front side...

Page 18: ...the start up screen Activating the Language button opens a selection window with different languages Use the arrow buttons to scroll through the list You can select your desired language directly in the corresponding line Displays the total operating time of the device Total number of shock waves generated by the device Button to enter Admin mode password protected Displays the version of the curr...

Page 19: ... with a diameter of 20 mm leads to a maximum energy level at a depth of 20 mm The diameter of the gel pad can be read on the gel pad in question For a longer service life we recommend storing the gel pads out of direct sunlight and at a temperature of between 1 C and 30 C Optimal energy transfer can only be guaranteed when conductive gel is used Depending on the size of the treatment area and the ...

Page 20: ...central control knob If the optional foot switch is connected the and pedals can be used for adjustment as well Apply conductive gel Apply the conductive gel to the treatment area and spread the gel evenly over the entire surface of the treatment area Start of therapy Note Note Start a treatment by selecting the Start button immediately followed by clicking the orange button on the handpiece 19 or...

Page 21: ...stable and is the result of the set energy level multiplied by the number of shocks 5 Number of shocks Displays the number of shocks set target and allows this to be adjusted and displays the number of shocks generated actual The maximum number of shocks is 10 000 and can been adjusted in increments of 100 shocks 6 Counter direction Is used to set the shock calculation method count up count down 7...

Page 22: ...eration instructions 7 3 Displays and buttons 7 Page 12 11 Protocols Switches to Protocols 12 Favourites Switches to Favourites 13 Therapy Switches to Therapy 14 Settings Switches to Settings 11 12 13 14 ...

Page 23: ...egion the window with corresponding indications will open Select indication Select the appropriate indication and press the Confirm button Therapy information The therapy screen will open with the corresponding treatment recommendations All parameters can be changed according the instructions in chapter 7 3 Start treatment Start the treatment by selecting the Start button immediately followed by c...

Page 24: ...tomatically listed in Favourites when saved Favourites list In the Favourites list the programmes can be 1 Accessed for therapy To do this select the desired programme directly in the corresponding line and then click the Confirm button 2 Deleted To delete a favourite select the corresponding treatment and click the Delete button ...

Page 25: ...eter Protection against ingress of particles and water Device IPX 0 Foot switch IPX 1 Dimensions W 405 mm x H 207 mm x D 424 mm Weight 23 kg control unit without accessories Operation 10 40 C 30 85 relative humidity without condensation at 700 1060 hPa Transport storage 10 50 C 20 85 relative humidity without condensation at 700 1060 hPa Gel pads should be stored at the customer s premises in a dr...

Page 26: ...d accessories in a hygienic dirt and dust free environment Reprocessing restrictions enShock and all its accessories do not need to be sterilised and are not intended for this purpose enShock and all its accessories are not suitable for machine cleaning and disinfection Initial treatment on the place of use All parts of the device that may come into contact with the patient must be cleaned during ...

Page 27: ...d alcohol free by Schülke When using disinfection wipes you should wipe 3 times Do not use disinfectant spray as the housing is not protected against the ingress of liquids Gel pads Disinfect the used gel pads after each time they come into contact with the patient using a commercially available non alcoholic plastic and metal disinfectant that is suitable for medical devices either in spray form ...

Page 28: ...use as this entails use on uninjured healthy skin and application in an uncritical hygienic environment The instructions listed above have been approved by the medical device manufacturer as suitable for reprocessing a medical device for reuse The reprocessor is responsible for ensuring that the reprocessing as actually performed using equipment materials and staff in the treatment facility achiev...

Page 29: ... the EC Directive on Medical Devices 93 42 EEC and meets the essential requirements of Appendix I of this directive The device is classified in class IIa according to Appendix IX of the directive Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany ...

Page 30: ...01000 1 Set of gel pads 54202500 1 Bottle with conductive gel 54201020 1 Power cable 10105114 1 Instructions for use Item no Accessories 5445 1 Handpiece 54201000 1 Set of gel pads 54202500 1 Bottle with conductive gel 54201010 1 Foot switch 5446 1 Equipment trolley 54201020 1 Power cable 10105114 1 Instructions for use ...

Page 31: ...not intended by the manufacturer to be combined with other devices or connected to other medical or non medical devices Anyone who combines devices against these guidelines thereby creating a medical system does so on his her own responsibility ...

Page 32: ...as ascertained functional safety a proper operating condition and mechanical integrity before using the device and accessories the device is operated only by medical professionals the device is not operated in hazardous areas and or a combustive atmosphere and the device is immediately disconnected from the mains when penetrated by liquid The device does not contain any parts that can be repaired ...

Page 33: ...ace is damaged the part must be replaced The handpiece has a life span of 5 000 000 shocks After 4 500 000 shocks the user will get a message to replace the applicator before reaching 5 000 000 shocks It is not possible to exceed the life span of 5 000 000 shocks Inspect the surface regularly for cracks and other damage If any surface is damaged the gel pad must be replaced Foot switch optional Re...

Page 34: ... pads and foot switch for any damage Perform the test as described below Connect the handpiece to the device If available connect the foot switch to the device No message functionality is guaranteed Handpiece not detected message check whether it is correctly attached to the device If the error recurs immediately inform the service department customer service ...

Page 35: ... the MPBetreibV Medical Device Operator Ordinance and DGUV V3 Accident Prevention Regulation Electrical Systems and Equipment among others apply in their respective current versions These are to be followed when operating the device Note These requirements apply to operation of the device in Germany Please consider any divergent national regulations in your country ...

Page 36: ...in Remedy for cause 2 Ensure that conductive gel is used Possible cause 3 Internal cable defect Remedy for cause 3 Check this by performing the Cable control test In the event of an error message inform the service department customer service No response when using the main switch display remains dark Possible cause 1 Mains connection Remedy for cause 1 Check that the mains plug is correctly plugg...

Page 37: ...t is essential that you notify 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 in Neu Ulm Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de Disposal The device and handpiece may only be returned to th...

Page 38: ...ich are not specified or provided by the manufacturer of this device can lead to increased electromagnetic interference emissions or decreased electromagnetic immunity of this device resulting in improper operation The enShock device does not contain any exchangeable components cables or other parts which lead to worsening of the EMC WARNING Portable HF communication devices including peripheral d...

Page 39: ... used in the electromagnetic environment indicated below The customer or user of the enShock device must ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment Guidelines Electrostatic discharge ESD according to IEC 61000 4 2 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV air discharge 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV ...

Page 40: ...evices which bear the following symbol interferences are possible Radiated electromagnetic HF fields according to IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM to 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Single phase at 0 Single phase at 0 When the user of the enShock device needs further operation even in the case of interruptions in the power supply it is recommended to operate the enShock device fr...

Page 41: ...z deviation 1 kHz sinus 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modulation ...

Page 42: ...tions for Use EN 10 105 114 I 0521 I Version 1 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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