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System Book

Identification

Inventory no.:
Serial numbers:
Intelect RPW Lite:
Handpiece:

Supplier

Address:

_______________________________

Tel.: _________________________

_______________________________

Fax: _________________________

_______________________________

E-mail: _________________________

_______________________________

Mobile: _________________________

Training of the operator

For information on operator training, please read

hapter

2.2.2 t

raining

the

OperatOr

Maintenance measures

Name

Position

Signature

EXCLUSIVELY DISTRIBUTED BY:

DJO France SAS | Centre Européen de Fret | 3 rue de Bethar | 64990 Mouguerre | France

T: + 33 (0) 5 59 52 86 90 | F: + 33 (0) 5 59 52 86 91

STORZ MEDICAL AG
Lohstampfestrasse 8
CH-8274 Tägerwilen
Switzerland

Содержание INTELECT RPW LITE

Страница 1: ...2 0002 Part no 30680 xxxx Published March 2019 Original language German Manufacturer Publisher STORZ MEDICAL AG Lohstampfestr 8 CH 8274 Tägerwilen Switzerland 13 30732 EN 30732 0002 INTELECT RPW LITE Operation Installation Instruction for Intelect RPW Lite ...

Страница 2: ...operation 9 2 2 1 Operating personnel 9 2 2 2 Training of the operator 9 3 Device Description 10 3 1 Control device with handpiece 10 3 2 Scope of supply 10 3 3 Unpacking the device 11 3 4 Transport base plate 11 3 5 Installation Instructions 12 3 5 1 Handpiece components 12 3 5 2 Assembling the handpiece 12 3 5 3 Connecting the electrical power supply 13 3 5 4 Connecting the handpiece 14 3 6 Comp...

Страница 3: ...ns fuse replacement 24 5 2 Maintenance 24 5 3 Disposal 24 5 4 Repair 24 5 5 Service life 25 6 Trouble shooting 25 7 Accessories 26 8 Technical Specifications and Conformity 27 8 1 Technical specifications 27 8 2 Intelect RPW Lite type plates 28 8 3 Conformity with directives 28 8 4 Conformity with standards 28 8 4 1 EMC guidelines and manufacturer s declaration 29 8 5 Certificates 33 8 6 Symbols a...

Страница 4: ...tuation of potential danger which if not avoided could lead to serious injury WARNING The source of the danger is stated here These are the possible consequences The instructions for avoiding the danger are given here CAUTION indicates that incorrect operation could lead to minor injuries CAUTION The source of the danger is stated here These are the possible consequences The instructions for avoid...

Страница 5: ...st time Read the separate operating manuals for all devices associated with the Intelect RPW Lite 1 1 1 Intended use and operational safety To ensure this device is utilised in accordance with its intended use the user must possess the necessary technical proficiency and knowledge of the operating man ual The device is only to be used for the applications described in Chapter 2 1 1 Indications Onl...

Страница 6: ...vel during administration of pulses is within the safe range Nevertheless we recommend wearing suitable ear protection during treatment in order to minimise exposure to noise 1 1 2 Safety during treatment of the patient General note Organs with gas inclusions are NOT allowed to be exposed to pulses As it passes through tissue the pulses energy is slightly reduced this reduction is significantly we...

Страница 7: ...es the Intelect RPW Lite must be tested in that particular environment to ensure that it functions correctly according to the technical specifications The use of RF communications equipment in the vicinity is not permitted The device must only be connected to properly earthed and correctly installed shockproof sockets Setup and operation There are ventilation slits on the rear of the device which ...

Страница 8: ...e surface in particular NOTE Medical devices operating on the basis of the above principle are generally referred to as radial shock wave systems in modern medical literature 2 1 1 Indications Pain in the musculoskeletal system Aesthetic non medical treatments to the skin muscles facial wrinkles connective tissue and tendons 2 1 2 Contraindications Treatment with the Chattanooga Intelect RPW Lite ...

Страница 9: ...ted in Chapter 2 1 1 Indications Users must have basic physical and cognitive abilities such as vision hearing and literacy and have basic functional use of their upper extremities The device is designed for a demographic target group between 18 and 65 years 2 2 2 Training of the operator Operators of the Intelect RPW Lite must have been trained in using this device safely and efficiently as follo...

Страница 10: ...er 6 Fig 3 1 Front of Intelect RPW Lite 1 2 1 Ventilation slits 2 Mains connector with mains switch and fuse Fig 3 2 Rear of Intelect RPW Lite 3 2 Scope of supply The standard scope of supply of the Intelect RPW Lite includes the following items Intelect RPW Lite control unit Mains cable Handpiece 1 pulse transmitter Standard hose Transport base plate Operating manual Gel bottle Open end spanner A...

Страница 11: ... useful for any later equipment transport A film indicating that you must read the operating manual is affixed to the device display Read the operating manual and then remove the film from the device 3 4 Transport base plate In order to protect it the device is supplied mounted on a transport base plate which is secured with hook and loop tape This must be removed before the device is started up R...

Страница 12: ...ttach the transport base plate when repackaging the device for transport 3 5 Installation Instructions 3 5 1 Handpiece components 1 2 3 4 5 6 7 8 1 Handpiece handle 2 Projectile 3 Allen key see Cleaning Overhaul 4 Guide tube 5 Shaft 6 Open end spanner 7 Pulse transmitter insert 8 Pulse transmitter screw caps 3 5 2 Assembling the handpiece Assemble the handpiece as follows Remove the guide tube and...

Страница 13: ...nto the handpiece until finger tight NOTE Depending on the pulse transmitter the pulse transmitter screw cap is in one or two pieces Here the images show how to assemble the handpiece with a two piece pulse transmitter screw cap 3 5 3 Connecting the electrical power supply Connect the mains cable to the mains connector on the left rear of the device see Fig 3 2 Insert the mains cable into the elec...

Страница 14: ...ection on the Intelect RPW Lite slide the orange ring in the direction of the Intelect RPW Lite or for the hand piece connection slide the red ring in the direction of the handpiece and pull the hose out of the connector 3 6 Compatibility The following handpieces may be operated with the Intelect RPW Lite SPARROW handpiece Chattanooga Art no 30885 x 4 Operation 4 1 Switching on Switch on the contr...

Страница 15: ... the counter reading reaches 9999 the display starts from zero again when the next pulse is triggered 4 4 Reading out the total number of pulses operating hours and software version To enable the total number of pulses the operating hours and the software version to be read out the device must be restarted Press during the restart The display will then show the total number of pulses followed by t...

Страница 16: ...er condition Read Chapter 1 General Safety Information before beginning treatment CAUTION If the handpiece is not positioned correctly there is a risk to health due to ineffective treatment Define the treatment zone and make sure that the handpiece position always corresponds to the treatment zone Make sure that the treatment is only performed by users who meet the conditions in Chapter 2 2 Precon...

Страница 17: ...ters Treatment should always start at a low intensity level This also applies when resuming treatment after an interruption The pulse energy should be increased gradually during treatment NOTE The selection of intensity levels is based on the medical opinion of the person administering the treatment The maximum intensity level used during treatment must not cause the patient undue pain under any c...

Страница 18: ...t must be cleaned before and after each treatment Wipe down the device parts with a damp cloth For cleaning use a lukewarm dilute solution of non vegetable soapy water ATTENTION It is essential that no fluid be permitted to penetrate either the device or its tubing Keep the ventilation slits clear Cleaning the handpiece The handpiece in particular the pulse transmitter must be thoroughly cleaned a...

Страница 19: ...ages show how to assemble the handpiece with a two piece pulse transmitter screw cap Unscrew the pulse transmitter screw cap from the handpiece Disconnect the handpiece from the control device Remove the pulse transmitter insert Insert the pulse transmitter insert into the corre sponding pulse transmitter screw cap Screw the pulse transmitter screw cap onto the handpiece until finger tight After r...

Страница 20: ...hol based dis infectant containing aldehyde follow the manufac turer s instructions Unscrew the pulse transmitter screw cap from the handpiece Unscrew the shaft from the handpiece and pull it out of the handpiece handle Use the supplied open end spanner for this pur pose Clean the guide tube using a brush Follow the instructions in reverse order to assemble the handpiece NOTE When assembling the h...

Страница 21: ...e transmitters and leave them to dry Wear gloves Only use alcohol based disinfectants containing aldehyde not formaldehyde for medical equipment Follow the manufacturer s information regarding the effectiveness and application of the disinfectant 5 1 4 Overhaul of the handpiece Due to the effects of friction the handpiece components are continuously exposed to mechanical stress which will cause mi...

Страница 22: ... open end spanner must be used to release and assemble the handpiece shaft when overhauling the handpiece Place the handpiece on a dry clean and dust free surface Disconnect the handpiece from the control device Pull the tightly fitting guide tube out of 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...

Страница 23: ...rew cap using an alcohol based disinfectant Take out the new guide tube and the new projectile from the overhaul kit Insert the guide tube into the opening in the shaft by pressing in as far as it will go Make sure that the end of the guide tube where the two air slots are located is in the direction of the handpiece handle Insert the new projectile into the fitted guide tube Screw the shaft into ...

Страница 24: ...ve maintenance is not necessarily required However regular maintenance may help to identify possible defects at an early stage and thus increase the safety and service life of the device Maintenance services can be ordered from the regional representatives in your area 5 3 Disposal When disposing of this medical product no special measures have to be observed Please proceed in accordance with appl...

Страница 25: ...ouble shooting Error Possible cause Corrective actions No pulse emitted Leaks in handpiece hose or hose not properly connected Guide tube installed the wrong way round Projectile missing Projectile is blocked Compressor defective Trigger button defective Have the connection checked and replaced if necessary Dismantle the handpiece turn the guide tube around Dismantle the handpiece check the projec...

Страница 26: ...l bottle 250 ml 22601 Mains cable CEE 3m long 0 0032 012 Mains cable CH 3m long 13448 CH Mains cable USA 0 0032 012 US Mains cable China 2 5 m long 13 7458 CN Handpiece holder 30883 Handpiece hose standard 30890 Intelect RPW Lite operating manual 30732 NOTE For further information and ordering data on the pulse transmitters please con tact your dealer ...

Страница 27: ...during storage and transport 500 1060 hPa Air humidity during operation 5 55 non condensing Air humidity during storage and transport 5 95 non condensing Control device weight 10 kg Handpiece weight 290 g Housing dimensions W x H x D incl handle 238 x 289 x 325 mm Classification according to MDD Class IIa device Subject to technical changes NOTE In the event of the medical product being transferre...

Страница 28: ...plies with the applicable standards EN IEC 60601 1 CAN CSA C22 2 No 601 1 UL Std No 60601 1 Acc to EN IEC 60601 1 Type of protection against electric shocks Protection class 2 with functional earth Application unit of type BF The requirements from the device safety essential performance standard in accordance with IEC 60601 1 3rd edition are satisfied The device is free of excessive pressure wave ...

Страница 29: ...romagnetic environment guidelines RF emissions acc to CISPR 11 Group 1 The Intelect RPW Lite uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions acc to CISPR 11 Class B The Intelect RPW Lite is suitable for use in all establishments including domestic establishments and those ...

Страница 30: ... or hospital environment Surges acc to IEC 61000 4 5 1 kV differential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage Mains power quality should be that of a typical commercial or hospital environment Voltage dips brief interruptions and fluctuations in the supply voltage acc to IEC 61000 4 11 5 UT 1 95 dip in UT for and 1 period 70 UT 30 dip in UT fo...

Страница 31: ...afety distance in metres m The field intensity of stationary radio transmitters based on an on site inspectiona should be less than the compliance levelb at all frequencies Interference may occur in the vicinity of devices 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 Propagation of electroma...

Страница 32: ...P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 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 transmitt...

Страница 33: ...15 700 02 0319 Technical Specifications and Conformity 33 8 5 Certificates Fig 8 2 Declaration of conformity ...

Страница 34: ...the Intelect RPW Lite Label Meaning 230 V type plate 115 V type plate 100 V type plate You must read the operating manual WEEE symbol Earth For this device version it is a functional earth UDI Unique Device Identification Barcode on the type plate for the machine readable identification of the medical product Table 1 2 Labelling ...

Страница 35: ...ed at no charge to the customer upon the customer furnishing adequate proof that the defect is due to defects in material or workmanship The warranty does not extend to wear parts In order to make a claim under the warranty the device must always have been correctly attached to the transport base plate for the purposes of transportation Transport costs and the risk of loss during the shipping of r...

Страница 36: ...__________ _______________________________ Mobile _________________________ 3 Training of the operator For information on operator training please read Chapter 2 2 2 Training of the operator 4 Maintenance measures Name Position Signature 2019 DJO 13 30732 EN Rev A 03 2019 EXCLUSIVELY DISTRIBUTED BY DJO France SAS Centre Européen de Fret 3 rue de Bethar 64990 Mouguerre France T 33 0 5 59 52 86 90 F...

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