Chattanooga INTELECT RPW LITE User manual

Operating Manual
Chattanooga Intelect RPW Lite
DS.#####
30732.0002
Part no. 30680.xxxx
Published: March 2019
Original language: German
Manufacturer / Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
13-30732-EN30732.0002
INTELECT®RPW LITE
Operation & Installation Instruction for
Intelect RPW Lite

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Table of Contents
2
Table of Contents
1 General Safety Information 5
1.1 Instructions for safe use 5
1.1.1 Intended use and operational safety 5
1.1.2 Safety during treatment of the patient 6
1.2 Warning against damage to equipment and the device 6
2 Principles 8
2.1 Physical principles 8
2.1.1 Indications 8
2.1.2 Contraindications 8
2.1.3 Side effects 9
2.2 Preconditions for 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 Compatibility 14
4 Operation 14
4.1 Switching on 14
4.2 Setting the intensity 14
4.3 Resetting the counter reading 15
4.4 Reading out the total number of pulses,
operating hours and software version 15

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Table of Contents
3
4.5 Start-up 16
4.6 Treatment 16
5 Cleaning, Maintenance, Overhaul 18
5.1 Cleaning and overhaul 18
5.1.1 Replacing the pulse transmitter 19
5.1.2 Cleaning the handpiece 20
5.1.3 Cleaning and disinfecting the pulse transmitter 21
5.1.4 Overhaul of the handpiece 21
5.1.5 Mains 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SpecicationsandConformity 27
8.1 Technicalspecications 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 Certicates 33
8.6 Symbols and labels 34
9 Warranty and Service 35
9.1 Warranty for the control device 35
9.2 Service 35
System Book 36

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Introduction
4
Introduction
Warning notes
This manual contains warnings, safety instructions and specic 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!
• The instructions for avoiding the danger are given here.
WARNING refers to a situation 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 avoiding the danger are given here.
ATTENTION indicates that incorrect operation could lead to damage to the device.
ATTENTION!
The source of the danger is stated here.
These are the possible consequences!
• The instructions for avoiding the danger are given here.

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General Safety Information
5
Other instructions
NOTE
Additional information concerning specic features or operating instructions
is preceded by the term 'NOTE'.
1 General Safety Information
1.1 Instructions for safe use
The following chapter contains all safety information that has to be followed when
working with the Intelect RPW Lite.
WARNING!
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 rst 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 prociency and knowledge of the operating man-
ual.
The device is only to be used for the applications described in
Chapter 2.1.1 indiCatiOns.
• Only perform treatments approved by the producer!
Furthermore, the device is only to be operated by trained personnel who meet the
preCOnditiOns fOr OperatiOn described in Chapter 2.2.
Checks and inspections prior to treatment
Before using the device, the user must make sure it is functioning safely and that it
is in proper condition.

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General Safety Information
6
Protection against electrical hazards
Sources of voltage can give rise to currents as a result of body resistance, which not
only ow through the patient but can also impair or even endanger the personnel
administering the treatment.
• Devices that are not medical products in accordance with EN 60601 must be
set up outside the patient environment.
• 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
completely reassembled!
Protection against noise
The noise level 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
signicantly weakened by the bone structure.
Pulses can give rise to undesirable reactions. The patient must be continuously observed
during the treatment and attention must be paid to any reactions experienced by the
patient. The patient must not be under anaesthetic.
Only perform treatments approved by the producer!
The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.
1.2 Warning against damage to equipment and the
device
Any damage to the device resulting from incorrect operation is not covered by the
manufacturer’s warranty.

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General Safety Information
7
Electromagnetic compatibility
This device complies with the requirements of the applicable standard on electro-
magnetic compatibility.
Nevertheless, portable and mobile RF communications equipment (e.g. mobile
phones) can interfere with medical electrical equipment.
This device is subject to special precautionary measures regarding EMC and must
be installed in accordance with the EMC directives.
The use of accessories or cabling not authorised by the manufacturer is not permit-
ted. 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 specications.
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 must not be covered by
other objects.
• Never cover the device when in use!
• Make absolutely sure that no liquid can seep into the system housing or handpiece.
The third mains connecting cable must only be used as the functional earth.
Storage and transport
Incorrect storage and transport can result in damage to the device and device
failure.
• Make sure that no cables are crushed or sheared.
Disposal
• Comply with national disposal regulations when disposing of the
Intelect RPW Lite or individual components.
• Comply with the relevant information in the operating manuals for the
additional devices.

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Principles
8
2 Principles
2.1 Physical principles
The Intelect RPW Lite is a compressed air-operated ballistic pressure wave generator.
Kinetic energy is converted into sound energy. This acoustic pulse is transmitted into
the tissue to be treated either directly or via an acoustic impedance adapter with the
help of a gel.
Physically speaking, these are radial pressure waves. The applied pressure pulse
propagates radially within the tissue and has a therapeutic effect on areas of the
tissue near the 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 is not permitted in the following
cases:
– Brain or spinal column in the treatment area
– Pregnancy
– Malignant tumour in the treatment area
CAUTION!
Pulses must not be applied to target areas located above air-lled
tissue nor to any regions near large nerves, vessels, the spinal col-
umn or head (except in the facial area).

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Principles
9
2.1.3 Side effects
Treatment with the Intelect RPW Lite may cause the following side effects:
– Swelling, reddening, haematomas
– Petechiae
– Pain
These side effects generally abate after 5 to 10 days.
2.2 Preconditions for operation
2.2.1 Operating personnel
The Intelect RPW Lite is intended exclusively for use by healthcare professionals
who have read the supplied documents.
Such a specialist is expected to have practical knowledge of medical procedures
and applications as well as of the technology and should be experienced in treating
the indications stated 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 efciently as follows:
– They must read and observe the operating manual as well as all other enclosed
documents .
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 about training in the operation of
this device can be obtained from your dealer.

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Device Description
10
3 Device Description
3.1 Control device with handpiece
1
2
3
4
5
1 Handle
2 Display
3 Trigger button
4 Handpiece connector
5 Handpiece with coloured
handpiece cushion
6 Pulse transmitter
6
Fig. 3-1 Front of Intelect RPW Lite
1
21 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
– Allen key
– Cleaning brush

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Device Description
11
Cables and accessories other than those specied or supplied by the manufacturer
must not be used.
3.3 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.
• Contact your supplier or the manufacturer/dealer immediately if any items are
missing or damaged.
• Retain the original packaging. It may prove useful for any later equipment
transport.
A lm indicating that you must read the operating manual is afxed to the device
display.
• Read the operating manual and then remove the lm 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.
Removing the transport base plate
• This plate must be removed before the device is used for the rst time.
• Undo the hook-and-loop tape.
• Lift the device from the base plate (Fig. 3-3).
1
2
1 Hook-and-loop tape
2 Transport base plate
3
4
3 Ribs
4 Slits
Fig. 3-3 Removing the transport base plate

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Device Description
12
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
t into the slits on the bottom of the device (see Fig. 3-3).
• Fasten the hook-and-loop tape around the transport handle.
ATTENTION!
Always attach the transport base plate when repackaging the device for
transport.
3.5 Installation Instructions
3.5.1 Handpiece components
12
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 the projectile from the
handpiece packaging.
• Unscrew the shaft from the handpiece and pull it
out of the handpiece handle.
• Use the supplied open-end spanner for this purpose.

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Device Description
13
• Insert the projectile into the tted guide tube.
• Screw the shaft onto the handpiece until n-
ger-tight.
• Tighten the shaft using the supplied open-end
spanner. It must no longer be possible to unscrew
the shaft by hand.
• Make sure that the cap parts of the pulse transmitter
are screwed rmly in place and that the pulse trans-
mitter screw cap is screwed rmly to the shaft.
• Insert the pulse transmitter insert into the corre-
sponding pulse transmitter screw cap.
• Screw the pulse transmitter screw cap onto the
handpiece until nger-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 electrical socket.
ATTENTION!
Maintain a minimum distance between the device and the wall so that the
mains plug can be pulled out without restriction (disconnected from the
power supply network) and the ventilation slits on the rear are not blocked.
The device must only be connected to properly earthed and correctly installed
shockproof sockets!

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Operation
14
3.5.4 Connecting the handpiece
• Plug the hose into the corresponding connector on the handpiece or the connector
on the front of the device.
1 Hose
2 Connector
3 Orange ring
1
122
3
Fig. 3-4 Connections between handpiece, hose and control device
• To check that the components have been connected correctly, gently pull on
the hose.
– You should not be able to pull the hose out.
• 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.
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 control device at the mains switch on the rear (see Fig. 3-2/2).
The device is operated via the touchscreen display.
4.2 Setting the intensity
The display indicates the intensity (levels 1 – 6).
Press to increase the intensity.
Press to decrease the intensity.

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Operation
15
0
10
20
30
40
50
60
70
80
90
100
123456
I ntens i tä t i n %
Level
Relationship between
intensity and frequency
Intensity Frequency
1 18 Hz
2 16 Hz
3 10 Hz
4 9 Hz
5 8 Hz
6 6 Hz
Fig. 4-5 Graphical representation of the intensity levels
The frequency changes automatically based on the intensity.
4.3 Resetting the counter reading
The display counts the pulses emitted.
Press to reset the display to zero.
When 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 the operating hours and then the software
version. The numbers will scroll along the 4-digit display
from left to right.
Total number of pulses e.g.: 1000 Σ
Operating hours e.g.: 3 h
Software version e.g.: 029 040-xx-xxxx
Level
Intensity in %

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Operation
16
4.5 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. Further treatment is possible.
4.6 Treatment
Safety information
Before using the device, the user must make sure it is functioning safely and in
proper 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!
• Dene 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 preCOnditiOns fOr OperatiOn.
• For safety reasons, using the device for applications other than those specied
in Chapter 1 general safety infOrMatiOn is not permitted!
CAUTION!
Over extended periods, the noise of the pulses may be per-
ceived as unpleasant!
• Offer ear protection to the patient.
• Recommendation: The user should also wear ear protection.

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Operation
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 – 400 pulses to the same spot during
treatment.
Apply enough coupling gel to ensure that the pulse transmitter glides smoothly over
the patient's skin.
Setting parameters
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 circumstances.
Coupling the handpiece
NOTE
Clean all parts which come into contact with the patient before and after
each treatment.
• Apply a sufcient amount of coupling gel to the patient’s skin in the treatment
area and to the pulse transmitter.
Avoid excessive pressure of the pulse transmitter to the patient‘s skin! Excessive
pressure is not necessary for the success of the treatment.

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Cleaning, Maintenance, Overhaul
18
5 Cleaning, Maintenance, Overhaul
5.1 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.
All parts which come into contact with the patient 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 uid 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 and
disinfected after each therapy session.
• Clean the coupling gel off the handpiece using a cleaning agent that is suitable
for surface cleaning.
• Disinfect the handpiece with an alcohol-based disinfectant that is suitable for
surface cleaning (follow the manufacturer's instructions).

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Cleaning, Maintenance, Overhaul
19
Component Procedure Interval
Handpiece shaft and
cushion
clean and disinfect daily or after 20,000 pulses
(whichever comes rst)
Guide tube clean from inside with
brush
every day
Pulse transmitters and
O-rings
clean in ultrasonic bath
and disinfect
after each treatment or
contact with a patient
Guide tube, projectile,
O-rings
replace after 1,000,000 pulses
Table 1-1 Cleaning intervals
5.1.1 Replacing the pulse transmitter
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.
• 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 nger-tight.
• After replacing the pulse transmitter, make sure that the handpiece cap and
the cap parts are screwed rmly in place.
NOTE
Make sure that the cap parts of the pulse transmitters are screwed rmly in
place and that the pulse transmitter screw cap is screwed rmly to the shaft.
Check the screw connection of the pulse transmitter screw cap and cap parts
during prolonged treatment phases.

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Cleaning, Maintenance, Overhaul
20
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.
• Clean the coupling gel off the handpiece using a
cleaning agent that is suitable for surface cleaning.
• Disinfect the handpiece with an alcohol-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 handpiece, always retighten the handpiece shaft using the sup-
plied open-end spanner. It must no longer be possible to unscrew the shaft by hand.