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Mobile 2 RPW User Manual

1. General Information

Explosion

1.3 PREREQUISITES FOR OPERATING THE DEVICE

1.3.1 OPERATOR

The device is intended exclusively for use by medical specialists and may only be used by qualified and instructed medical persons.
Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the terminology, and
should be experienced in treating the indications stated in chapter 1.1.1.
The specialist must have the basic physical and cognitive prerequisites such as vision, hearing and reading. Furthermore, the basic
functions of the upper extremities must be guaranteed. The instrument is designed for a demographic target group between 18 and
65 years.

1.3.2 TRAINING OF THE OPERATOR

Operators of the device must have been adequately trained in using this system safely and efficiently before they operate the
instrument described in this handbook. An introduction to the principles of operation will be provided by your dealer with reference
to this operating manual and will be documented in the system logbook.

The operator must be instructed in the following points:

•

Instruction in operation and designated use of the instrument with practical exercises

•

Mechanism of action and function of the instrument and the energies delivered by it

•

All component settings

•

Indications for use of the instrument

•

Contraindications and side effects of the therapy waves

•

Explanation of the warning notes in all operating statuses

•

Instruction in how to perform the functional checks

Further training requirements vary from country to country. It is the operator’s responsibility to ensure that the training meets the
requirements of all applicable local laws and regulations. Further information on training in the operation of this system is available
from your dealer. However, you can also contact the following address directly:

DJO, LLC

1430 DECISION STREET

VISTA, CA 92081

USA

T: +1 800

494

3395

E:

CHATTPRODUCTSUPPORT

@DJOGLOBAL.COM

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Содержание Mobile 2 RPW USA

Страница 1: ...User Manual Mobile 2 RPW USA Operation Installation Instructions for Mobile 2 RPW USA Radial Pressure Wave REF 2905 US Rx only ...

Страница 2: ...1 Handpiece holder installation 10 2 3 2 Connecting power supply cables 11 2 3 3 Handpiece connection 12 2 3 4 Potential equalisation optional 12 3 Operation 13 3 1 General warnings and safety information 13 3 2 Start up 14 3 3 Functional checks 16 3 4 Standard settings 16 3 5 Treatment 17 3 6 Info menu 18 3 7 Resetting the handpiece shock counter 18 4 Cleaning Maintenance Overhaul 19 4 1 Cleaning...

Страница 3: ...pair 42 8 9 Service life 42 8 10 Trouble shooting 43 8 11 Accessories and Spare Parts 43 8 12 Applicator Specifications 44 9 V ACTOR II Specifications and Operation 45 9 1 Scope of supply 46 9 2 Unpacking 46 9 3 Connecting the handpiece 46 9 4 Replacing the transmitter 47 9 5 General warnings and safety information 48 9 6 Setting the V ACTOR ii treatment parameters 48 9 7 Start up 49 9 8 Functiona...

Страница 4: ...s manual will also enable you to react promptly and effectively in the event of malfunctions and errors When using optional accessories please also refer to the separate operating manuals for each of these accessories It is imperative that users be familiar with the content of this manual before operating any part of this system The device is a compressed air operated ballistic shock wave generato...

Страница 5: ...e unconscious or anyone who cannot give verbal consent or warnings about pain 1 1 3 WARNINGS AND PRECAUTIONS Do not use in the presence of unexplained pain If a patient reports significant or unexpected pain immediately stop the treatment and consult a physician Do not apply pulses to any regions near large nerves vessels the spinal column or head ALWAYS move the handpiece over the treatment area ...

Страница 6: ...on Council Directive 2012 19 EU concerning Waste Electrical and Electronic Equipment WEEE Indicates a requirement not to dispose of WEEE as municipal waste Contact your local distributor for information regarding disposal of the unit and accessories Wear hearing protection USB connection 2 0 x x Name and address of the manufacturer and manufacturing date Complies with the Medical Device Directive ...

Страница 7: ...scribed in this handbook An introduction to the principles of operation will be provided by your dealer with reference to this operating manual and will be documented in the system logbook The operator must be instructed in the following points Instruction in operation and designated use of the instrument with practical exercises Mechanism of action and function of the instrument and the energies ...

Страница 8: ...1 1 Front view of the device 1 Display of selected shock frequency 2 Treatment shock counter 3 Display of selected pressure nominal value 4 Shock counter reset button 5 Dial for setting the pressure 6 Handpiece 7 Handpiece connector 8 Buttons for setting the shock frequency Fig 1 2 Side view of the device 3 2 1 5 4 8 6 7 7 ...

Страница 9: ... connection 5 Potential equalisation connection 6 Mains fuse holder 7 Mains switch NOTE The USB connection Fig 1 3 is only suitable for connecting a USB memory stick which supports the USB V1 1 protocol Fig 1 4 Back cover of the device 1 4 2 COMPRESSED AIR SUPPLY The compressed air is supplied by an integrated compressor 3 2 1 5 4 6 7 ...

Страница 10: ... supplier or the manufacturer immediately if any items are missing or damaged Retain the original packaging It may prove useful for any later equipment transport 2 2 SCOPE OF SUPPLY The standard scope of supply of the Mobile 2 RPW USA includes the following items Control device R SW handpiece Mains cables Gel bottle User manual Service set 2 Transmitters Please refer to chapter 6 ACCESSORIES AND S...

Страница 11: ...stallation Instructions 2 3 INSTALLATION 2 3 1 HANDPIECE HOLDER INSTALLATION The handpiece can be placed on the right or on the left side of the system Fig 2 1 Position of the handpiece holder Fig 2 2 Position of the handpiece holder ...

Страница 12: ...nection Fig 2 3 1 on the rear of the instrument Fig 2 3 Connecting power supply cables Insert the mains plug into the socket ATTENTION When setting up the instrument make sure that the air outlets on the housing of the device are not blocked The instrument must only be connected to properly earthed and correctly installed shockproof sockets 1 ...

Страница 13: ...the red dots on the handpiece connection Fig 2 5 Fig 2 5 Connecting the handpiece Place the handpiece into the handpiece holder 2 3 4 POTENTIAL EQUALISATION OPTIONAL The device features a potential equalisation connection Fig 1 3 5 Where necessary connections for potential equalisation must be made by suitably qualified personnel The potential equalization connection must be connected in accordanc...

Страница 14: ...t Risk of electric shocks Risk of transmission of microorganisms Disinfect the handpiece after each treatment Also refer to chapter 4 CLEANING MAINTENANCE OVERHAUL for details ATTENTION Check that the installation surfaces have sufficient carrying capacity to avoid equipment damage Portable and mobile HF communications equipment e g mobile phones can interfere with electrical equipment The use of ...

Страница 15: ...en the devices Connect the devices to an outlet on a circuit different from that to which the other device is connected Consult the manufacturer or field service technician for help 3 2 START UP NOTE Prior to start up please refer to chapter 8 and 9 for your handpiece Switch on the device at the mains switch on the back of the instrument Fig 1 3 7 Once the unit has been started the display automat...

Страница 16: ...of 1 0 bar is required Press the trigger button on the handpiece To work in single shock mode select the symbol dash in the Frequency selection box and activate the trigger button To work in continuous shock mode select a continuous shock frequency in the range from Operating Mode Energy Frequency R SW 1 0 4 0 bar max 21 Hz R SW 4 6 bar max 15 Hz R SW 5 0 bar max 12 Hz V ACTOR 1 4 3 0 bar max 31 H...

Страница 17: ...er on the front of the instrument Set the pressure to maximum 5 bar Release individual shocks in single shock mode Release shocks in continuous shock mode shock frequency 1 Hz and 8 Hz Test the other frequencies as follows Operating Mode Energy Frequency R SW 4 0 bar max 21 Hz R SW 4 6 bar max 15 Hz R SW 5 0 bar max 12 Hz V ACTOR 3 0 bar max 31 Hz V ACTOR 3 8 bar max 22 Hz V ACTOR 5 0 bar max 13 H...

Страница 18: ... 1 INDICATIONS is not allowed All status and error messages signaled during treatment must always be attended to without delay The maximum energy level used during treatment must not cause the patient undue pain under any circumstances CAUTION We recommend that the user and the patient wear suitable hearing protection Always offer the patient hearing protection Apply a sufficient amount of couplin...

Страница 19: ...l to move up or down in the menu in order to call up the following data Menu Item Display 1 Handpiece pulse counter 2 Total pulse counter 3 Operating hours counter 4 Hardware article no 5 Hardware change index 6 Not used 7 Software article no 8 Software change index 9 Boot loader article no 10 Not used NOTE Shock counter displays 1 and 2 display the shock count in steps of one thousand To exit the...

Страница 20: ...INS FUSE REPLACEMENT The mains fuse holder is located on the rear panel of the device Push the clip of the mains fuse holder Fig 4 1 1 to the left and take the holder off the housing Fig 4 1 Mains fuse holder Pull the old fuses out of the mains fuse holder Fig 4 2 Fig 4 2 Fuse replacement Replace the fuses Use type T4AL 250 VAC fuses Push the mains fuse holder back into the opening until it engage...

Страница 21: ...release of shock waves or pressure pulses Proceed as follows Switch off the instrument at the mains switch on the rear panel and disconnect the mains power link cable from the connection on the compressor Remove the condensate collector from the holder and empty it Remove the pressure filter housing It can be unscrewed by hand Fig 4 3 Unscrewing the pressure filter housing Fig 4 4 Pressure filter ...

Страница 22: ...ilter housing Ensure that both O rings Fig 4 5 1 and Fig 4 5 2 do not slip and are not misplaced 1 2 Fig 4 5 Filter element holder removed Disassemble the filter element holder Fig 4 5 Filter element holder disassembled Remove the bottom of the filter element holder Fig 4 6 Bottom of filter element holder removed ...

Страница 23: ...filter housing When connecting the pressure filter housing with the top of the filter element ensure that the top of the filter element audibly engages Ensure that both O rings Fig 4 5 1 and Fig 4 5 2 do not slip and are not misplaced Fig 4 9 Inserting the filter element holder into the pressure filter housing Screw the pressure filter housing finger tight into the holder Ensure that the housing i...

Страница 24: ...tions 4 5 DISPOSAL When disposing of the present medical products no special measures have to be observed Please proceed in accordance with applicable country specific regulations After expiration of its service life dispose the device as waste electronic equipment 4 6 REPAIR Repair work on defective instruments must only be carried out by personnel suitably authorised by DJO LLC Use only original...

Страница 25: ...d operation is possible Error 20 Internal fault Acknowledge by pressing the reset button continued operation is possible Error 21 Internal fault Acknowledge by pressing the reset button continued operation is possible Error 22 Problem with update on USB stick Acknowledge by pressing the reset button Check update on stick continued operation is possible Error 23 USB stick not inserted Insert USB st...

Страница 26: ...connections and replace them if necessary Check the compressor air filter and replace it if necessary No shock wave power output No compressed air supply Blocked or worn projectile Malfunction in control device Handpiece defective Dismantle the handpiece Clean the guide tube and projectile Overhaul the handpiece Call your Service centre Replace the handpiece 6 Accessories and Spare Parts Descripti...

Страница 27: ...nt air pressure during storage and transport 500 1060 hPa Air humidity 5 95 non condensing Control device weight 8 2 kg Housing dimensions W x H x D 490 x 290 x 400 mm Classification according to MDD Class IIa device Protection against the ingress of water IPX1 Subject to technical modifications Equipment safety essential performance according to IEC 60601 1 3rd edition ME equipment shall be free ...

Страница 28: ...electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emitted interference measurements Compliance Electromagnetic environment guidelines HF emissions according to CISPR 11 Group 1 The device uses HF energy only for its internal functioning Therfore its HF emissions are very low and are not likely to cause any interf...

Страница 29: ...ould be that of a typical commercial or hospital environment Surges according to IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage drops short interruptions and voltage variations on power supply input lines according to IEC 61000 4 11 5 UT 95 drop in UT for ...

Страница 30: ...cturer and d is the recommended safety distance in metres m The field intensity of stationary radio transmitters based on an on site inspection a should be less than the compliance level b Interference may occur in the vicinity of instruments marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elec...

Страница 31: ... d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended safety distance can be estimated using the equation applicable to the frequency of the transmitter where P is the rated power of the transmitter in watts W according to the tr...

Страница 32: ...31 Mobile 2 RPW User Manual 7 Technical Specifications of the Control Device ...

Страница 33: ...ating instructions is preceded by the term NOTE CAUTION Before using the R SW handpiece for the first time please ensure that you have read and understood all the infor mation provided in this operating manual Familiarity with the information and instructions contained in this manual is essential for ensuring efficient and optimal use of the instrument for avoiding hazards to personnel and equipme...

Страница 34: ...handpiece is shipped fully assembled but if the transmitter ever requires replacement do the following CAUTION Cleaning agents and disinfectants can form an explosive atmosphere Disconnect the handpiece from the control device before starting any cleaning or maintenance work ATTENTION It is essential that no fluid be permitted to penetrate either the instrument or its tubing Regular cleaning ensur...

Страница 35: ...shock is released while the shock transmitter and the shock transmitter screw cap are removed The safety catch is also activated if the shock transmitter screw cap is not screwed on tightly if the sealing ring between the cap and the shock transmitter is missing or if two sealing rings old and new come together at the rear of the shock transmitter CAUTION Danger of injury due to pulse triggering w...

Страница 36: ...ly to the shaft Check the screw connection of the shock transmitter screw cap and cap parts during prolonged treatment phases 8 3 CLEANING OF THE HANDPIECE NOTE After cleaning the handpiece must be dry before it can be reassembled For that reason schedule sufficient time for the drying of the handpiece and its components Disconnect the handpiece from the control device 1 Unscrew the transmitter sc...

Страница 37: ... spanner for this purpose 4 4 5 Clean the guide tube with a brush in order to ensure perfect projectile movement 6 The protective cushion can be pulled back and up off the handpiece handle to clean the handpiece 7 DANGER If the unit is not safe for operation it must be repaired by a certified service technician and the operators must be informed of the dangers posed by the unit ...

Страница 38: ...E The transmitter insert of the transmitters D20 S D20 T and D35 S can only be dismantled and the sealing rings can only be removed using special tools You should avoid doing this because it could result in damage to the transmitter It is not necessary for cleaning purposes We also recommend that the transmitters should be cleaned and disinfected in an ultrasonic bath For this purpose use only ins...

Страница 39: ...nically Due to the effects of friction the handpiece components are continuously exposed to mechanical stress which will cause minor wear NOTE The R SW handpiece should be overhauled about every 1 000 000 shocks This can be done quickly and easily by the user of the instrument All that is required is the overhaul kit that includes all required wearing parts 8 5 1 CONTENTS OF THE R SW OVERHAUL KIT ...

Страница 40: ...from the handpiece and pull it out of the handpiece handle 5 Use the supplied open end spanner for this purpose 5 4 5 Remove the tightly fitting guide tube from the shaft If necessary use a thin metal rod or the supplied hexagonal spanner as a pulling tool by inserting it through the openings in the guide tube 6 A corresponding fixture is provided in the handpiece handle to hold the projectile bac...

Страница 41: ... shaft the transmitter including firmly seated sealing rings and the transmit ter screw cap with an alcohol based disinfectant These are reused after cleaning 10 NOTE The transmitter insert can only be dismantled and the sealing rings can only be remo ved using special tools You should avoid doing this because it could result in damage to the transmitter It is not necessary for cleaning purposes ...

Страница 42: ...o the opening in the shaft by pressing it until it hits the stop Make sure that the end of the guide tube where the two air slots are located is in the direction of the handpiece handle 12 Insert the new projectile into the fitted guide tube 13 Mount the new sealing ring from the overhaul kit onto the shaft Screw the shaft into the handpiece until finger tight Hold the handpiece firmly on the tabl...

Страница 43: ...ice life of the handpiece please return the instrument to DJO LLC 8 8 REPAIR Repair work on defective instruments must only be carried out by personnel suitably authorised by DJO LLC Use only original parts designated by STORZ MEDICAL AG and supplied by DJO LLC The personnel suitably authorised can be from DJO LLC or be repre sentatives of DJO LLC agencies and dealers 8 9 SERVICE LIFE The R SW han...

Страница 44: ...dpiece Install a projectile Turn the guide tube around Irregular frequency 2 projectiles Remove one projectile Leak in the handpiece connector Defective or missing red O ring on plug Send in handpiece or inform Service 8 11 ACCESSORIES AND SPARE PARTS Handpiece overhaul kit 23825 Shaft cushion 22376 Handle cushion 22375 Shock transmitters Detailed ordering information for the complete shock transm...

Страница 45: ...ity during storage and transport 5 95 non condensing Air humidity during operation Max 55 non condensing in cases of local or seasonal elevated air humidity we recommend the use of a commercially available air dehu midifier Weight 510 g 1 12 lb Protection Against Ingress of Water IPXO Subject to technical changes This device complies with the applicable standards EN 60601 1 CAN CSA C22 2 No 601 1 ...

Страница 46: ...eact promptly and effec tively in the event of malfunctions and errors When using optional accessories please also refer to the separate operating manuals for each of these accesso ries It is imperative that users be familiar with the content of this manual before operating any part of this system The V ACTOR ll is a vibration therapy handpiece and can be used as an optional accessory for radial p...

Страница 47: ...are supplied with a transmitter screw cap 9 2 UNPACKING Carefully remove the handpiece from the packaging Check that all items are included in the packaging container and that they are not damaged Contact your supplier or the manufacturer immediately if any items are missing or damaged 9 3 CONNECTING THE HANDPIECE NOTE Please also refer to chapter 3 for operation of your control device Connect the...

Страница 48: ...er in reverse order Screw the new transmitter onto the handpiece until finger tight 1 2 Fig 9 4 Replacing the transmitter V25 V40 To remove the transmitter V40 unscrew the transmitter from the handpiece Unscrew the transmitter screw cap and pull the transmitter out Remove the sealing ring by pressing it apart at the cut through point To clean press the spring element together slightly and remove t...

Страница 49: ...f the location of the treatment zone is the responsibility of the user Only perform treatments approved by STORZ MEDICAL AG Risk of transmission of microorganisms Clean the handpiece after each use Refer to Chapter 9 11 Cleaning for details 9 6 SETTING THE V ACTOR II TREATMENT PARAMETERS The V ACTOR operating mode is called up automatically on the control device display when the V ACTOR ll handpie...

Страница 50: ...9 9 STANDARD SETTINGS Start the V ACTOR II treatment at an energy level of 2 bar and a frequency of 20 Hz For more detailed instructions refer to the application brochure and the treatment recommendations 9 10 TREATMENT CAUTION Read Chapter 3 1 General Warnings And Safety Information before beginning treatment NOTE The maximum energy level used during treatment must not cause the patient undue pai...

Страница 51: ... if necessary The shock transmitters can be cleaned using the usual cleaning agents and disinfectants Clean the shock transmitters each day in an ultrasonic bath Proceed as follows to clean the shock transmitters V40 shock transmitter Unscrew the shock transmitter from the handpiece disassemble the threaded two part shock transmitter screw cap remove the shock transmitter insert from the front cap...

Страница 52: ...sing of the V ACTOR ll handpiece Please proceed in accordance with applicable country specific regulations The instrument must be disposed of as waste electronic equipment at the end of its service life 9 13 REPAIR Repair work on defective instruments must only be carried out by personnel suitably authorised by DJO LLC Use only original parts designated by STORZ MEDICAL AG and supplied by DJO LLC ...

Страница 53: ...handpiece ca ble or cable not prop erly connected Check the cable and tube connections and replace them if necessary No power output Handpiece defective Replace the handpiece CAUTION Disconnect the handpiece from the control device before starting any maintenance work 9 16 ACCESSORIES AND SPARE PARTS V ACTOR II handpiece set 28730 25 mm transmitter 28740 40 mm transmitter 28741 ...

Страница 54: ...torage and transport 500 1060 hPa Ambient air pressure during operation 800 1060 hPa Air humidity 5 95 non condensing Weight 370g Protection against the ingress of water IPX0 Subject to technical modifications NOTE When the medical product is distributed to third parties the following must be observed The complete device documentation must be delivered together with the medical product The medical...

Страница 55: ...elling dealer or a certified Company service technician Defects or damage caused by labor furnished by someone other than Company the selling dealer or a certified Company service technician Any malfunction or failure in the Product caused by product misuse including but not limited to the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the Product User...

Страница 56: ...the case with the repair label filled in completely Missing components will be replaced subject to charge Accessories also sent will be checked and if necessary replaced after we have assessed them Shock transmitters and overhaul kits are not covered by the handpiece s warranty 10 3 SERVICE Should you have any further questions or require additional information please feel free to contact your dea...

Страница 57: ...56 Mobile 2 RPW User Manual ...

Страница 58: ...ORZ MEDICAL AG Lohstampfestrasse 8 CH 8274 Tägerwilen Switzerland 2016 DJO 13 00060 US EN Rev A 05 2018 DJO LLC 1430 DECISION STREET VISTA CA 92081 USA T 1 800 494 3395 E CHATTPRODUCTSUPPORT DJOGLOBAL COM ...

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