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Chattanooga Intelect RPW Lite
Operation & Installation Instruction for
30732.0002
30732.0002
O
perating
INTELECT
Part no. 30680.xxxx
Published: March 2019
Original language: German
Manufacturer / Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
Intelect RPW Lite
CH-8274 Tägerwilen
M
anual
RPW LITE
®
DS.#####
Switzerland
13-30732-EN
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Summary of Contents for Chattanooga INTELECT RPW LITE
- Page 1 Chattanooga Intelect RPW Lite RPW LITE INTELECT ® DS.##### Part no. 30680.xxxx Published: March 2019 Original language: German Manufacturer / Publisher: Operation & Installation Instruction for STORZ MEDICAL AG Lohstampfestr. 8 Intelect RPW Lite CH-8274 Tägerwilen Switzerland 30732.0002 13-30732-EN 30732.0002...
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Page 2: Table Of Contents
Table of Contents General Safety Information Instructions for safe use 1.1.1 Intended use and operational safety 1.1.2 Safety during treatment of the patient Warning against damage to equipment and the device Principles Physical principles 2.1.1 Indications 2.1.2 Contraindications 2.1.3 Side effects Preconditions for operation 2.2.1 Operating personnel... - Page 3 Maintenance Disposal Repair Service life Trouble-shooting Accessories Technical Specifications and Conformity 8.1 Technical specifications Intelect RPW Lite type plates Conformity with directives Conformity with standards 8.4.1 EMC guidelines and manufacturer's declaration 8.5 Certificates Symbols and labels Warranty and Service Warranty for the control device...
- Page 4 Introduction Warning notes This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations. DANGER refers to a situation of acute danger which, if not avoided, could lead to serious or fatal injury. DANGER! The source of the danger is stated here. These are the possible consequences! •...
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Page 5: General Safety Information
Incorrect handling of the device. Risk of injuries to the patient and the operating personnel! • Read this chapter carefully before using the Intelect RPW Lite for the first time. • Read the separate operating manuals for all devices associated with the Intelect RPW Lite. -
Page 6: Safety During Treatment Of The Patient
Do not touch electrical connectors while you are touching the patient. • Disconnect the mains plug before starting any cleaning and maintenance work on the Intelect RPW Lite! • Disconnect the connected handpieces from the device before carrying out cleaning and maintenance work. Do not reconnect them until they have been... - Page 7 Increased electromagnetic interference may occur, which may cause the device to function incorrectly. Do not position the Intelect RPW Lite immediately next to or together with other devices. If the device does have to be operated near to or together with other devices, the Intelect RPW Lite must be tested in that particular environment to ensure that it functions correctly according to the technical specifications.
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Page 8: Principles
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 is not permitted in the following cases: – Brain or spinal column in the treatment area –... -
Page 9: Side Effects
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 follows: – They must read and observe the operating manual as well as all other enclosed documents . -
Page 10: Device Description
Mains connector with mains switch and fuse Fig. 3-2 Rear of Intelect RPW Lite Scope of supply The standard scope of supply of the Intelect RPW Lite includes the following items: – Intelect RPW Lite control unit – Operating manual –... -
Page 11: Unpacking The Device
Cables and accessories other than those specified or supplied by the manufacturer must not be used. Unpacking the device • Check that all items are included in the packaging container and that they are not damaged. • Remove the device and accessories from the packaging container. Proceed with extreme caution. -
Page 12: Installation Instructions
Attaching the transport base plate • To reattach the base plate, place the hook-and-loop tape underneath the base plate. • Lift the device onto the base plate so that the ribs on the transport base plate fit into the slits on the bottom of the device (see Fig. 3-3). •... -
Page 13: Connecting The Electrical Power Supply
• Insert the projectile into the fitted guide tube. • Screw the shaft onto the handpiece until fin- ger-tight. • Tighten the shaft using the supplied open-end spanner. It must no longer be possible to unscrew the shaft by hand. •... -
Page 14: Connecting The Handpiece
To disconnect the connections, for the connection 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. -
Page 15: Resetting The Counter Reading
Relationship between intensity and frequency Intensity Frequency 18 Hz 16 Hz 10 Hz 9 Hz 8 Hz 6 Hz Level Level Fig. 4-5 Graphical representation of the intensity levels The frequency changes automatically based on the intensity. Resetting the counter reading The display counts the pulses emitted. -
Page 16: Start-Up
Start-up • Set the intensity of the pulses to the required intensity level. • Before each treatment, make sure that the pulse counter is set to zero. • Press the trigger button on the device (Fig. 3-1/3). – When you press the trigger button again, the pulses will stop being emitted. NOTE If 2000 pulses are reached during the treatment, the handpiece stops auto- matically. - Page 17 ATTENTION! Inadvertent pulse triggering may result in damage of the device Only trigger pulses when the handpiece is in contact with the intended treat- ment zone. • Avoid excessive pressure of the pulse transmitter to the patient's skin! Excessive pressure is not necessary for the success of the treatment. CAUTION! To prevent the risk of swelling, petechiae and haematomas, do not apply more than 300 –...
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Page 18: Cleaning, Maintenance, Overhaul
Cleaning, Maintenance, Overhaul Cleaning and overhaul Regular cleaning ensures perfect hygiene and operation of the Intelect RPW Lite. CAUTION! Electrical hazard! Disconnect the device from the mains before starting any cleaning and overhauling work! • Unplug the mains plug ! The frequency of complete exterior cleaning depends on the frequency of use and what the device is used for. -
Page 19: Replacing The Pulse Transmitter
Component Procedure Interval Handpiece shaft and clean and disinfect daily or after 20,000 pulses cushion (whichever comes first) Guide tube clean from inside with every day brush Pulse transmitters and clean in ultrasonic bath after each treatment or O-rings and disinfect contact with a patient Guide tube, projectile, replace... -
Page 20: Cleaning The Handpiece
5.1.2 Cleaning the handpiece NOTE After cleaning, the handpiece must be dry before it can be reassembled. • Disconnect the handpiece from the control device. • Unscrew the pulse transmitter screw cap from the handpiece. • Clean the coupling gel off the handpiece using a cleaning agent that is suitable for surface cleaning. -
Page 21: Cleaning And Disinfecting The Pulse Transmitter
5.1.3 Cleaning and disinfecting the pulse transmitter • Unscrew the pulse transmitter screw cap and remove the pulse transmitter insert from the pulse transmitter screw cap (see C 5.1.1 r hapter eplaCing the pulse transMitter • Clean all of the parts under running water and dry them. •... - Page 22 Contents of the overhaul kit – 2 projectiles – 2 boxes of sealing rings – 2 guide tubes – 1 O-ring guide The overhaul kit can be ordered from your dealer. Overhauling the handpiece CAUTION! Danger of injury due to pulse triggering when handpiece is open.
- Page 23 • A corresponding fixture is provided in the hand- piece handle to hold back the projectile. To remove the projectile, hold the handpiece handle with its opening pointing down. Firmly knock the handle against the table surface until the projectile falls out. In the event that the projectile breaks apart due to overloading, a fragment of the projectile may be left behind inside the guide tube.
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Page 24: Mains Fuse Replacement
5.1.5 Mains fuse replacement The mains fuse holder is located on the rear of the Intelect RPW Lite between the mains connection and the ON/OFF switch. • At the indentations, push the two slides of the mains fuse holder inward and pull the holder from the housing. -
Page 25: Service Life
Of the handpieCe the mean time to failure (MTTF) in accordance with EN 60601-1:2005 + A1:2012 is: – approx. 5000 hours for the Intelect RPW Lite device – 1 million pulses for the pulse transmitter – 5 million pulses for the handpiece For servicing, contact your local distributor. -
Page 26: Accessories
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. 15 700 02 0319... -
Page 27: Technical Specifications And Conformity
Technical Specifications and Conformity Technical specifications Intelect RPW Lite Mains input voltage 100 VAC // 115 VAC // 230 VAC Mains frequency 60 Hz // 60 Hz 50 – 60 Hz Mains fuse T 8 AH / 250 VAC Power consumption Max. 700 VA Ambient temperature during 10 °C –... -
Page 28: Intelect Rpw Lite Type Plates
Intelect RPW Lite type plates Fig. 8-1 230 V 115 V 100 V Conformity with directives This medical product bears the CE mark in accordance with the Medical Device Directive (MDD) 93/42/EEC. Conformity with standards This device complies with the applicable standards EN/IEC 60601-1, CAN / CSA-C22.2 No.601.1, UL Std. -
Page 29: Emc Guidelines And Manufacturer's Declaration
Guidelines and manufacturer's declaration – emitted electromagnetic interference The Intelect RPW Lite model is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect RPW Lite should assure that it is used in such an environment. - Page 30 The Intelect RPW Lite model is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect RPW Lite should assure that it is used in such an environment. IEC 60601 Electromagnetic environment –...
- Page 31 Guidelines and manufacturer's declaration – resistance to emitted electromagnetic interference The Intelect RPW Lite model is intended for use in the electromagnetic environment specified below. The customer or the user of the Intelect RPW Lite should assure that it is used in such an environment. IEC 60601 Compliance Immunity tests Electromagnetic environment –...
- Page 32 The Intelect RPW Lite is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The operator or the user of the Intelect RPW Lite can help to prevent electromagnetic interference by complying with minimum distances between portable and mobile RF communications equipment (transmitters) and the Intelect RPW Lite as recommended below according to the maximum output power of the communications equipment.
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Page 33: Certificates
Certificates Fig. 8-2 Declaration of conformity 15 700 02 0319... -
Page 34: Symbols And Labels
Symbols and labels The following symbols and labels are affixed to 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 eart... -
Page 35: Warranty And Service
Warranty and Service ATTENTION! Modifications to the device, handpiece and the pulse transmitters are not permitted. Any unauthorised opening, repair or modification of the device by unauthorised personnel will relieve the manufacturer of its liability and responsibility for safe system operation. This will automatically void the warranty even before the end of the warranty period. -
Page 36: System Book
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 C 2.2.2 t hapter...