WELLSYSTEM MEDWAVE TOUCH User manual

JK-International GmbH
Köhlershohner Straße 60
53578 Windhagen
GERMANY
Tel.: [phone] / 818-257
Fax: [phone] / 818-254
E-Mail: [email protected]
1026388
Operating instructions
MEDWAVE_TOUCH
MEDWAVE_TOUCH

1026388-00A / en / 06.2021
0197
Operating instructions
Dry water massage device
Date of issue 10.02.2021
Translation of the original operating instructions
wellsystem
TOUCH
MEDWAVE
wellsystem

Legal notice
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Legal notice
Manufacturer: JK-Products GmbH
Köhlershohner Straße 60
53578 Windhagen
GERMANY
Tel.: [phone] / 818-140
Fax: [phone] / 818-166
Customer service /
Technical service
(Spare part orders for
components):
JK-International GmbH,
Division JK-Global Service
Köhlershohner Straße 60
53578 Windhagen
GERMANY
Tel.: [phone] / 818-863
Fax: [phone] / 818-205
E-Mail:[e-mail]
Spare part orders for
consumables: JK-International GmbH
Köhlershohner Straße 60
53578 Windhagen
GERMANY
Tel.: [phone] / 818-257
Fax: [phone] / 818-254
E-Mail:[e-mail]
DANGER!
Failure to observe these instructions:
• can result inserious injury and death,
• can result indamage to the device and the
environment.
– Read these instructions carefully before putting this
device intooperation.
–Please observe theinstructionsand the code ofcon-
duct required tooperate the devicesafely.
–Please makethe instructionsand additional information
fromthe manufacturer availableto thepersonnel at
their workplace.
Copyright
The copyrightremains with JK-Holding GmbH.
The contentsmay not be partially or completely duplicated,distributed or
utilized for competitionpurposes without authorisation or disclosed toother
parties.
The rightto make technical changes in regard to the figures and information
contained in this instruction manual is reserved!

Table of contents
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Table of contents
1Safety instructions and warnings..................................................6
1.1 General................................................................................................6
1.1.1 Definitions............................................................................................6
1.1.2 Symbol explanation.............................................................................7
1.1.3 Symbols on the device........................................................................8
1.2 Use.......................................................................................................9
1.2.1 Purpose ...............................................................................................9
1.2.2 Intended use........................................................................................9
1.3 Foreseeable misuse..........................................................................10
1.4 Safety information for the dry water massage system....................10
1.4.1 Contraindications ..............................................................................10
1.4.2 Indications .........................................................................................11
1.5 Safety instructions and warnings .....................................................12
1.5.1 Operator's obligations.......................................................................12
1.5.2 Personnel training.............................................................................12
1.5.3 Scope of delivery...............................................................................12
1.5.4 Transport, assembly and setup........................................................13
1.5.5 Commissioning..................................................................................16
1.5.6 Operation and maintenance.............................................................16
1.5.7 Decommissioning..............................................................................17
1.5.8 Storage..............................................................................................17
1.5.9 Disposal.............................................................................................17
1.5.10 Directives...........................................................................................18
1.5.11 Export.................................................................................................18
1.5.12 Technical modifications ....................................................................18
1.6 Signs and stickers on the device......................................................19
1.7 Warranty............................................................................................23
1.8 Warranty and liability exclusions......................................................23
2Description.......................................................................................24
2.1 Scope of delivery...............................................................................24
2.1.1 Accessories (optional) ......................................................................24
2.1.2 Optional .............................................................................................24
2.2 Device description.............................................................................25
2.3 Accessories (optional) ......................................................................26
2.4 Functional description.......................................................................26
2.4.1 Massage areas..................................................................................27
2.4.2 Massage technique...........................................................................28
2.4.3 Control panel key lock ......................................................................28

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3Operation..........................................................................................30
3.1 Application tips..................................................................................30
3.1.1 Safety instructions.............................................................................30
3.1.2 Preparing the patients ......................................................................30
3.1.3 Using the extension cushion............................................................30
3.2 Operating overview...........................................................................31
3.2.1 Navigation / operation.......................................................................32
3.3 Starting a massage...........................................................................34
3.3.1 Starting using an NFC card..............................................................37
3.3.2 Using a coin unit to start...................................................................41
3.3.3 Start without payment, NFC card or PIN code................................43
3.3.4 Settings during the massage............................................................45
3.3.5 Expert Mode setting..........................................................................50
3.4 Ending a massage............................................................................51
3.4.1 Interrupting the massage..................................................................52
3.4.2 Terminating the massage before the time has expired..................53
3.5 NFC service card..............................................................................54
3.6 Default massage program................................................................55
3.6.1 Additional massage programmes for massage areas....................57
3.6.2 Own programme...............................................................................57
3.7 Charge credit onto NFC card...........................................................59
3.8 LED Light Show................................................................................61
4Cleaning and maintenance............................................................62
4.1 Safety instructions for maintenance.................................................62
4.2 Faults.................................................................................................63
4.3 Cleaning and disinfection .................................................................63
4.3.1 Disinfection........................................................................................64
4.3.2 Cleaning the surfaces.......................................................................65
4.4 Maintenanceperformed by theCustomer Service department.....66
4.5 Maintenance performed by the operator.........................................67
4.5.1 Daily visual inspection......................................................................67
4.5.2 Venting...............................................................................................67
5Technical data.................................................................................70
5.1 Power, connection rating and weight...............................................70
5.2 Water and cooling conditions...........................................................71
5.3 Dimensions........................................................................................72
5.4 Spare parts and accessories............................................................72
6Pre-configuring the settings.........................................................73
6.1 Unit settings (Setup Manager).........................................................73
6.1.1 Opening Setup Manager ..................................................................74
6.1.2 Operationof the Setup Manager......................................................75

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7Appendix..........................................................................................76
7.1 wellsystem MEDWAVE TOUCH: EMC information........................76
7.1.1 Table 201: Guidelinesand manufacturer's declaration –
Electromagnetic emissions..............................................................76
7.1.2 Table 202: Guidelinesand manufacturer's declaration –
Electromagnetic interference...........................................................77
7.1.3 Table 204: Guidelinesand manufacturer's declaration –
Electromagnetic interference...........................................................78
7.1.4 Table 206: Recommended safe distances between portable
and mobile HF communications equipment and wellsystem
MEDWAVE TOUCH..........................................................................79
7.1.5 Influence by elecromagnetic interference........................................79
7.2 Form for reporting incidents .............................................................79
8Index..................................................................................................80

Safety instructions and warnings
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1 Safety instructions and warnings
To ensure safe operation ofthe device, it is necessary toread the following
safety instructions and warnings carefullyand comply with them.
The safetyinstructions summarized here are repeatedin the corresponding
chapters, where necessary.
1.1 General
1.1.1 Definitions
Operator
Person who provides dry water massage devices on a commercial basis.The
operator is responsiblefor the orderly operationof the device aswell as com-
pliance with the maintenance intervals.
User/Patient
Person who uses thedry water massage device ata commercial location.
Personnel
People who are responsiblefor the operation, cleaningand general mainte-
nance work.
Electrician
A person with suitable professional training,knowledge, experience and
knowledgeof the applicable regulations which enable them to identify and
avoid thedangers whichcan arise fromworking with electricity.
Authorized, trained and qualified personnel
Qualifiedstaff from an external company who have been trained and author-
ized by the manufacturer to undertakeassembly and maintenance work on
specific equipment.
Dry water massage device
Inthese operating instructionsthe dry water massagedevice is referred to in
theshort form 'device'.

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1.1.2 Symbol explanation
The following types of safety notices are employed in these operating instruc-
tions:
DANGER!
Type and source of hazard
This safety notice indicates theexistence ofa direct danger
tobody and life.
DANGER!
Type and source of hazard
This safety notice warns ofdangers to bodyand life which
are caused by electricity.
WARNING!
Type and source of hazard
This safety notice warns of machine,material or environ-
mentaldamage.
NOTE:
This symboldoes not identify any safetynotices, but pro-
vides additional informationto better understand the pro-
cesses.

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1.1.3 Symbols on the device
The following symbolsare displayed on thedevice or on the packaging:
Manufacturer, productionyear and month
Type BF application part
Electric unit label (do not dispose of via householdrefuse)
No continuous operation
ESD-sensitive components
Readthe operatinginstructions!
Stack amaximum of 2units.
Maximum transport weight.
This way up.
Only place loads on theedge.
Protect againstwetness and moisture.
Temperature limits
Recyclablematerial.
Permitted air pressure during transport and storage.

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1.2 Use
1.2.1 Purpose
wellsystem MEDWAVE TOUCH permits a dry water massage through the
physical stimulation of certain massage zones (groups ofmuscles) of the
human body thathave been chosen according to physiological correctness
using controlled and temperature-controlled water pressure via anelectric
mat.
The medical device is indicated for therapy or toassist in the therapy ofmus-
cular / musculoskeletal disorders anddysfunctions and the pain caused by
this.
The therapy in the formof a dry water massage can be carried out onadult
patientsof all body sizes, agesand constitution. Infants andsmallchildren up
to theage of 7 maynot be subject to a therapy usingthe wellsystem medical
products. Children and adolescents from 8 to 17 years of age are onlyal-
lowed to use wellsystem medical products in agreementwith a parent or
guardian and after consulting a doctor.
The therapy with wellsystem MEDWAVE TOUCHmustbe carried out and
accompanied by trained specialised staff. The medical product is not indicat-
ed for use in private households.
The durationand type of treatment must be determined by your doctor.
The unit mayonly be used by people with a heart pacemaker after consulta-
tion with a doctor.
1.2.2 Intended use
This deviceis used to apply a dry water massage toone adult patient using
the programmes described in these operatinginstructions. More detailed
information can be found onpages 26 and 30.
The device is only intendedfor commercial use (e.g.for use in doctors surger-
ies, byphysical therapists or in hospitals andclinics) and not for domestic
use.
The unit mayonly be operated by trained specialist personnel.Patients may
notoperate the unit.
A water cooling system must be connected to thedevice if it is to beused for
more than 1hour per day at maximum pressure. The pressure hoses must
not be removed.Please contact the customer service departmentwithout fail
before putting the device into operation- see page 2.
The device may only beoperated with the pressure hose included inthe
scope ofdelivery.
Any other use shallbe considered improper.The manufacturer cannot be
held liable for damage or injuriesresulting from this.The operator bears the
sole risk for this.
Proper use also includescompliance with the manufacturer’s instructions and
its operating and maintenance conditions.The device may only be operated,
maintained and repaired by trained professionals familiar with this device and
who have beeninformed of the dangers involved.

Safety instructions and warnings
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1.3 Foreseeable misuse
The following uses of the device are explicitly prohibited:
Multiplepatients maynot use the device at the same time.
Peoplewith a body weightof more than 210 kg may not use the device.
The device must never be usedin combination with other medical devic-
es.
The unit mayonly be put into operation ifthe well has been filled with the
specified amount of water.
The unit maynot be connected to thepower supply during filling!
The unit mayno longer be moved once thewell has been filled!
Devices without a cooling system connectedmay only be used for a
maximumof 1 hour per day at maximum pressure.
1.4 Safety information for the dry water
massage system
1.4.1 Contraindications
NOTE!
Pay attentionto local contraindications (e.g. arm,leg) which
mean that useof the unit is fully excluded
Withthe following contraindications, a therapy usingthe wellsystem MED-
WAVE TOUCHmust not be carried out:
Fresh wounds
Acuteinflammations
Infections
Suspected phlebitis and thrombosis (danger of embolism)
Severely painfulmuscle stiffnesswith additionalmyogelosis (only target-
ed,regulated and local procedures with local techniques)
The stateafter operations have been carried outon the vertebrae at the
point in time when sufficient posture andmobility stability still cannot be
expected, i.e. in general the initial application isonly possible after 8
weeks atthe earliest
The stateafter vertebral fractures, againinitial application is only possible
after 8 weeks at the earliest
Acute disease patterns, especially with radicular symptoms, in which high
tensioningof the posture muscles is actually desirable
Painfulvertebrae blockages with reactive muscle stiffness
Vertebral disorderswith increased inflammation parameters (spondylitis,
rheumatic spondylarthritis)
Acuteexacerbation ofchronic symptoms
Bechterew's disease (inflammatory condition of the bone joints)
High-grade scoliosis
The stateafter joint endoprosthetic surgery 6 weekspost-op
Neurologicaldisorders withmotor and sensory defects

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Haematoma in areas to be treated
Chronic polyarthritis (chronic joint inflammation)
Functionalvertebrae defects in patients with (medication-based) coagula-
tion disorders
On peoplewith abody weight of more than 210kg
Incases of a dissociated form ofsensory loss (restricted temperature
sensation)
1.4.2 Indications
The medicalproduct is indicated for:
Muscular / musculoskeletal dysfunctionsand the pain caused by this.
Muscular / musculoskeletal disorders and thepain caused by this.
The indications specified above maybe caused by various medicalcauses or
disease patterns such as,for example, the following (the reference for evi-
dence thatthese disease patterns can betreated and alleviated using a mas-
sage is found in brackets):
Backache and joint pain (belongs to the indicationof muscular and mus-
culoskeletalpains)
Muscletension (belongsto the indication of muscular dysfunction)
Muscle dysbalance (belongs to the indication of muscular dysfunction)
Stress-related muscular tension (belongs to the indication of muscular
dysfunction)
Cervicalmigraines
Fibromyalgia (mild form)
Muscle imbalances (belongs to the indicationof muscular dysfunction)
Potential reversal offunctional disorders of the spinal column (belongs to
theindication of musculoskeletal disorder)
Cervical and thoracic spinal conditions,sciatica
Bloodcirculation and metabolism
(Chronic) venous congestion syndrome
Muscletone disorder (belongs to the indication of muscular dysfunction)

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1.5 Safety instructions and warnings
1.5.1 Operator's obligations
As the operator you are responsiblefor providing clear operating,cleaning
and maintenance instructions and ensuring the intended use and theproper
operation ofthe device by means of training and instruction for thepersonnel.
Your operating instructions must enable thesafe use andsafe operation of
the device andtake into account the characteristics and expertise ofyour
company and also the nationalwork safety andenvironmental protection
regulations (within the European Union,the EU directive 89/391/EEC).
In accordance with Directive 93/42/EEC or 2017/745/EU, accidents or other
incidents involving the dry water massage device must be reported to the
responsible authority – see page79 .
Commissioning of the device isprohibitedin the event of
defective cables,
defective plugs,
defective housing parts,
malfunctions.
1.5.2 Personnel training
The device is only to beused by personnel whoare able to accept responsi-
bility for correct operationdue to their training, knowledge or practicalexperi-
ence.
As the operator you are obligedto train your personnel andinstruct themin
theestablished legaland accident prevention regulations. Ensure thatyour
staffhave understood and observe these operation instructions. Thisapplies,
in particular to the
Information in 'Intended use' and 'Foreseeable misuse'
Safetynotes in Chapter 1.4and Chapter 'Operation'
Operating instructions
Cleaning,disinfection and maintenance instructions
–Please makethe instructionsand additional information from the manu-
facturer available to the personnelat their workplace.
– Regularly check your personnel's safety consciousness and awareness
ofthe risks, taking into account your operating instructions.
– You must ensure that the cleaningand disinfection intervals are complied
with, in particular cleaningand disinfectionafter every session.
– You must ensure that your staff provide your user/patients with appropri-
ateadvice, in particular regarding the types of application, possible risks
and the operation of the device.
–Do notallow children to play with the device.Cleaning and user mainte-
nance tasks mustnot be carried outby children.
1.5.3 Scope of delivery
Information regarding the scope of delivery is contained in the 'Description'
chapter onpage 24.

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1.5.4 Transport, assembly and setup
The device may not be mounted on the palett!
The device is delivered by aspecialist company and assembled and setup by
the manufacturer's own service personnel or by anauthorized service com-
pany.
As the operator you are responsiblefor abidingby the electrical regulations
applicableat the installation siteas well as adhering to thestipulated water
pressure and thepermitted coolant temperature,see 'Setup location'.

Safety instructions and warnings
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Assembly
DANGER!
Personal danger dueto electric shock or burns!
– The assembly andelectrical connection must comply
with the national regulations.
– The on-site electrical installation mustbe fitted with an
easily accessible all-pole isolatingdevice (master
switch), complying with overvoltage category III. This
means thateach pole must have a contact opening
width complying with the conditions of overvoltage cat-
egory III for full isolation in accordance with IEC 60447.
– wellsystem MEDWAVE TOUCH issubject to special
preventive measures with regard to the electromagnetic
compatibility and must be installedand commissioned
according to theEMC instructions obtained from the
assemblyinstructions.
–
Assembly, installation, upgrading or servicing ofthe unit
may onlybe carried out bypersonnel specially trained
and authorised by JK-Global Service.
–The unit mustonly be connected to themains supply
with a protective earth lead to prevent therisk of an
electric shock.
Information regarding the disassembly and assemblyof the device isavaila-
ble in theseparate assembly instructions. These assembly instructions are
intended solely for use by the manufacturer's service personnelor by qualified
specialistsauthorized by the manufacturer.

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Setup location
WARNING!
Overheating from inadequate cooling!
The device might be damaged!
–Maintain the minimum distances fromthe walls! Dimen-
sions are given onpage 72.
–Do notchange, obstruct or block the air inflow and
outflow to thedevice or make any unauthorized chang-
es to the device.
Salty air! Contaminated air!
Unit maybe damaged due tocorrosion of the housingand
ofelectric components.
– Where possible, do notset up theunitat a swimming
pool.
– Do notoperate the unit in locations with aggressive
ambientconditions (for example, with air containing
chlorine,in an oxygen enriched environment).
Damage to device possible!
Where there are great differences in temperature between
thetransport route and the installation site thedevice may
notbe put into operationimmediately after being setup.
–Waitat least 2 hours before connectingthe device to
thepower supply.
Environmental conditions
Optimum ambient temperature: Between +15 °C and +32 °C
Storage and transporttemperature:
Storage temperature: Between -15 °C and +60 °C (the well, pump and
the hoses mustnot contain any water)
Relative humidity and air pressure for transport, storageand operation:
Relative humidity: Between 30 % and75 %
Air pressure: Between 794hPa and 1060 hPa
Water and coolingconditions
Permissible water pressure (water inlet):0.8 MPa (8 bar)
Maximum coolant temperature: 16°C
The device is not to be used outdoors.
The device is not suitable for operationin mobile facilities (ships, buses, trains
or oil platform). The unithas to be adapted inorder to guaranteetrouble-free
operation when usedin mobile facilities.
Adaptation of the unit is required for operating altitudes greater than 2000m
above sea level in order toguarantee trouble-free operation.
Please contactthe Customer service department without fail before putting
the device into operation - see page2.

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1.5.5 Commissioning
Initialcommissioning will beundertaken by the manufacturer's own service
personnel or by an authorized service company.The device will be handed
over ready for use.
Ifthe device has not been usedfor a longer periodof time then itmust first be
inspected byour customer service staff or by another authorized company
before being putback into operation again.
The device is only to beused if it is working correctly!
None of thesafety devices (e.g.switch) or safety warnings are to be removed
or deactivatedas this would impair the safe operation of the device!
The unit mayonly be put into operation ifthe well has been filled with the
specified amount of water.
The unit maynot be connected to thepower supply during filling!
The unit mayno longer be moved once thewell has been filled!
A water cooling system must be connected to thedevice if it is to beused for
more than 1hour per day at maximum pressure. The pressure hoses must
not be removed.Please contact the customer service departmentwithout fail
before putting the device into operation- see page 2.
The device may only beoperated with the pressure hose included inthe
scope ofdelivery.
A water shut-off valve must be used.
A free outlet must be provided;in doing so, a minimum distance mustbe
maintained that must be larger thantwice the inner diameter of the supply
tube.Most effectively,the free outlet (air bridge) preventsthe backflow into
thepublic water supply mains.
Highfrequency mobile communication systems can interfere with the way the
devicefunctions.
Heat therapy devices (microwave therapy devices, etc.) installed in the vicinity
may leadto electromagnetic interference. Contact our customer service de-
partmentif this happens – seepage 2.
The device must be connected to themains via an all pole master switch.
One power supplycircuit (power supply lead) may onlypower one device.
Venting
The tank must be vented 3 days after commissioning or after ithas been
initially filled – see page67. After this, venting is unnecessary unlessleak-
ages occur and the tank has to be topped up.
The device may no longer beused in the event of water loss (puddles on the
floor).Please inform our customer service department –see page 2.
1.5.6 Operation and maintenance
Error-free operation, maintenance and service are required inorder to ensure
thatthe health and safety of the patients is notendangered during operation
and to ensure that the device is in a fault-free operating condition.
Always abide by the information and recommendations given in this operating
manual.Ensure that the intervals for theinspection, maintenance and service
are compliedwith. The maintenance work must be carried out bythe custom-
er services of the manufacturer or by qualified specialist personnel authorized
by the manufacturer following a check list.

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Unauthorized modifications andchanges to the device and its control unit are
prohibited.Failure to comply with this voids the operating licence!
To avoid hazards,the devicemust not be used ifthe mains power cable is
damaged. Adamaged mains power cable must be replaced by themanufac-
turer or their customer services,or by trained andqualified specialist person-
nel.
The current operatinghours can be calledup in “Default settings”,see chap-
ter 6.
We would like to point out that the device must besubjected to regular in-
spections by our customer service or an approved specialized company every
12 months(from commissioning) to maintain its proper condition!
1.5.7 Decommissioning
The device must be disconnected fromthe power supply in order to tempo-
rarily or permanentlydecommissionit.
You mustabide by the legaldisposal requirements when permanentlyde-
commissioning the device.
1.5.8 Storage
Store theunits in a dry, frost-free location witha stable temperature. The well,
pump and hosesmust not contain any water. Once the unit has cooled off,
pack itin plastic wrapping to protect it against scratches.
Storage temperature between -15 °Cand +60 °C (the well,pump and hoses
must not contain any water)
1.5.9 Disposal
Environmental regulations – disposal of batteries
Batteriescontain heavymetal compounds.
Within the European Union the national implementation of the Waste Frame-
work Directive2018/851/ECapplies. According to the national waste disposal
laws and in accordance with the community waste regulations, proof must be
provided of the proper disposal ofbatteries.
Operating water disposal
The device is filled with normaltap water without additives. The water canbe
drained offinto the public sewage system after it has been used.
Packaging
All packagingconsists of 100 % recyclablematerials. Packaging broughtinto
circulationby the JK Corporate Group that is no longer required can be re-
turned to the JK Corporate Group. Your partner agency or dealer will be hap-
py to advise.
Disposal of old devices
The device hasbeen manufactured using recyclable materials. The JKCorpo-
rate Group will provide you with information on the content or potential haz-
ards of thematerials used.

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The manufacturer is obliged to take back anddispose of certain electrical and
electronic components in accordance with the 2012/19/EC Directive.
The componentsand devices are labelled with the following symbol:
The device will, if requested, be properly disposed ofby the JK Corporate
Group. Thisservice is available free of charge.Your partner agency or dealer
will be happy to advise.
Registration numbers
Companies within the JK Corporate Group are registered asmanufacturers in
Germany andaccept allobligations in respect of the German Electrical and
Electronic Equipment Act.
Registry number JK-Products GmbH (Devices): WEEE-DE 62655951
1.5.10 Directives
This devicewas built accordingto the following guidelines:
EU directivefor medical products 93/42/EEC (according to the version
validat the time).
1.5.11 Export
We emphasize thatthese devices are only intended for the European market
and mustnot be exported to or operatedin other countries e.g. the USA or
Canada! Themanufacturer does not acceptany liability in the event of non-
observance! We explicitly emphasize that non-compliance may result inhigh
liabilityrisks for the exporter and/or theoperator.
1.5.12 Technical modifications
The device hasbeen constructed in accordance withthe current state-of-the-
art andthe applicable safety regulations.The illustrations and specifications
on these instructions are subject to technicalmodifications which are required
in order to improve the device.
Unauthorized modifications andchanges to the device and its control unit are
prohibited.Failure to comply with this voids the operating licence!
Please use onlyoriginalspare parts. Any liability for damage or injury proven
to be the result of the use ofnon-genuine spare parts is excluded.