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DJO, LLC

   

|

   2900 Lake Vista Drive   

|

   Dallas, TX 75067   

|

   U.S.A.

www.DJOglobal.com

© 

01

/20

20

 DJO - 

13

-28660

-EN

 - R

ev C

DJO France SAS
Centre Européen de Frêt 3 rue de Bethar
64990 Mouguerre  •  France
T: + 33 (0) 5 59 52 86 90  •  F: + 33 (0) 5 59 52 86 91
DJOglobal.com

Содержание Intellect RPW 2

Страница 1: ...EN Quick Start Guide ...

Страница 2: ...cautions 9 Adverse Effects 9 Patient Applied Parts 10 Product Description 11 Components 12 IFU Download 13 System Start Up 13 Device Connected to the Mains 13 To stop treatment 13 Caution 14 Warning 15 Danger 16 Unpacking the Device 17 Device Description 19 Falcon Handpiece Setup 20 Powering up the Device 21 Operating Data and Ratings 22 Falcon Handpiece Technical 22 Specifications Software 22 Tra...

Страница 3: ...se auditory and visual signals Read and understand cautions and contraindications of the device The operator shall operate only one device at a time and treat one patient at a time The device is not intended to be operated by the patient INTENDED ENVIRONMENT FOR USE The device is intended to be operated in a clinical environment it can be moved from room to room The device is not intended to be re...

Страница 4: ...at would result in death or serious injury WARNING DANGER PRECAUTIONARY INSTRUCTIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols Understand these symbols and their definitions before operating this equipment The definition of these symbols are as follows CAUTION Text with a CAUTION indicator explains possible safety infractions ...

Страница 5: ...otocols Treatment Data Clinical Resources Home Settings USB Drive DESCRIPTION OF DEVICE MARKINGS Refer to Instructional Manual and Quick Start Guide Booklet Warning Caution or Danger Electrical Type B Equipment Play Pause ON OFF Manufacturer Date of manufacture Catalogue number Serial number Fragile handle with care This end up Keep dry Temperature Range ...

Страница 6: ...Relative Humidity Range Atmospheric Pressure Range Testing agency CE Mark of Conformity with notified body number Class 1 equipment Radio frequency equipment WEEE Directive conformity Shelf life Batch number No condensation allowed Read the instruction for use AC Rated supply voltage ...

Страница 7: ...n promotes blood flow through the tissue and boosting metabolism Pulse vibration Massage Soothing relief from muscle strain and stress Disorder of Tendon Insertions Plantar Fasciitis heel Pain or heel Spur Plantar Fasciitis is an inflammatory condition of the foot caused by excessive wear to the plantar facia that supports the arch Tendinosis Calcarea Supraspinatus Tendon Shoulder calcifications a...

Страница 8: ...ced sensory and nervous function in the polyneuropathic area Cortisone therapy Wait minimum 6 weeks after local cortisone injection before treatment with radial pressure waves Haemophilia Thrombosis Deep vein thrombosis or other coagulation disorders Anticoagulant pharmaceuticals On any Neoplastic tissues or space occupying lesions Reduced thermal sensitivity over the proposed area of treatment un...

Страница 9: ...ated tissues Care therefore should be used in treating patients with therapeutic Radial Pressure Wave treatment who have bleeding disorders Frequent monitoring of intensity level and skin response should occur during all treatments Always apply the transmitter on the skin with small circular movements Never use Radial Pressure Wave therapy on the head Do not treat direct in an area with a metal im...

Страница 10: ...LI Type B F15 PTFE Type B D20 S Steel 1 4542 Type B D35 S Steel 1 4542 Type B D20 T Titan grade 5 ELI Type B Ro40 Steel 1 4021 Type B R15 Steel 1 4021 Type B V10 POM C LSG ACETRON Type B V25 POM C LSG ACETRON Type B V40 POM C LSG ACETRON Type B PERI ACTORS POM C LSG ACETRON Type B SPINE ACTORS Polyvinylidenfluorid EpoFlon ECTFE Halar Type B Ultrasonic gel Water de ionized water Gel PH7 Type B ...

Страница 11: ...energy When the projectile impacts against an immovable surface the shock transmitter this kinetic energy is converted into sound energy This acoustic pulse is transmitted into the tissue to be treated directly with the help of a gel These waves are physically classified as radial pressure waves The applied pressure pulse propagates radially within the tissue and has a therapeutic effect on areas ...

Страница 12: ...water based with deionized water No formaldehyde no fat For external use only Pouch COMPONENTS Throughout these instructions the terms left and right referring to the device sides are from the perspective of a user standing in front of the device The components of the Intelect RPW 2 are shown below Falcon Handpiece Gel Holder ...

Страница 13: ...he other end of the cord into an electrical outlet Note The Power Cord may be unplugged from the back of the device in an emergency situation 2 Connect the Falcon handpiece on the right connector 3 Turn on the power switch located on the back of the device TO STOP TREATMENT Press Play Pause button to pause treatment then press Stop on touch screen If device is on mains power press the On Off butto...

Страница 14: ...than DJO s can degrade minimum safety Connect to this device only items and equipment that have been specified in this IFU as part of the Intelect RPW 2 System or that have been specified as being compatible with the Intelect RPW 2 System DO NOT disassemble modify or remodel the device or accessories This may cause device damage malfunction electrical shock fire or personal injury Before using the...

Страница 15: ... should be used no closer than 30 cm 12 inches to any part of the Intelect RPW 2 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Use of accessories handpieces and transmitters other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagn...

Страница 16: ...ic tile If floors are covered with synthetic material DJO recommends implementing additional controls to maintain relative humidity to at least 35 Communicate these ESD precautionary procedures to healthcare staff contractors visitors and patients DO NOT block the device s vents Potential electromagnetic or other interference could occur to thsi or other equipment Try to minimize this interference...

Страница 17: ...e damage due to transport 3 Verify that the packaging contains the following Intelect RPW 2 device Intelect RPW 2 Quick Start Guide USB Stick Pouch Gel Holder Cables Holder Power cord Conductor Transmission Gel 250 ml 8 5 oz bottle Standard Accessory Kit that Includes the following RPW Falcon Handpiece Applicator Projectile R0 40 15 mm ESWT Transmitter D20 S D ACTOR 20 mm Transmitter Sealing Set G...

Страница 18: ...y side of the device 7 The cable holder is used to hang the handpieces cables Throughout these instructions the terms left and right referring to the machine sides are from the perspective of a user standing in front of the device The components of the Intelect RPW 2 are shown below ...

Страница 19: ...e button Falcon Hand Piece Support Transmitter Tray Holder USB Connector Rotary adjusment Knob V actor applicator support Switch ON OFF Power Button Device delivered with 2 transmitters Other transmitters displayed are optional V actor applicator is optional ...

Страница 20: ...inger tight Using one hand press the handpiece firmly onto the table and tighten the shaft using the open end spanner It must no longer be possible to unscrew the shaft by hand 4 Screw the transmitter screw cap with the required transmitter firmly back onto the shaft For two part transmitter caps Make sure that the two cap parts are screwed firmly in place and that the transmitter screw cap is scr...

Страница 21: ...st the device starts 2 The first setup screen will be displayed after this allowing the user to set language and time in the device 3 If after this step you see the screen below switch of the device and follow instructions in point 4 below If you do not see this screen the device is ready to use 4 Insert the supplied USB drive into USB port of device 5 Switch on the Intelect RPW 2 device The devic...

Страница 22: ...ling Pulse Width approx 6 12 ms Pulse Frequency 1 21 Hz for RPW 1 50 Hz for Vibration Fuses 2 x T6 3A H 250 V 5x20 mm Electrical Class CLASS I Electrical Type Degree of Protection TYPE B Regulatory Risk Class IIa according to MDD 93 42 EEC Mass 29 Kg 64 lbs Safe Working Load 5 Kg 11 lbs FALCON HANDPIECE TECHNICAL SPECIFICATIONS Compressed air input 1 0 5 0 bar Ambient temperature during operation ...

Страница 23: ...very well perceived among therapists thanks to its positive outcomes and its relatively short treatment period TREATMENT TIPS Let your patient rest in a relaxing position during a treatment session providing them a rolled up towel under their limb for comfort if needed during an elevated treatment Localise the painful points you plan to treat It might be a good idea to mark up the points with a fe...

Страница 24: ...e Vista Drive Dallas TX 75067 U S A www DJOglobal com 01 2020 DJO 13 28660 EN Rev C DJO France SAS Centre Européen de Frêt 3 rue de Bethar 64990 Mouguerre France T 33 0 5 59 52 86 90 F 33 0 5 59 52 86 91 DJOglobal com ...

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