Summary of Contents for schwa-medico StimaWELL 120MTRS
- Page 1 Operating Manual Art. No. 101781-V05 ® StimaWELL 120MTRS DYNAMIC DEEP WAVE THERAPY (DTW)
- Page 2 OPERATING MANUAL STIMAWELL® 120MTRS Dear customer, ® We would like to thank you for deciding to acquire the StimaWELL 120MTRS. You now have a high quality dynamic deep wave therapy system which has been designed to exploit the latest technological advances in this field. By means of a twelve channel, heat treatment stimulation mat you are now able to offer your patient a multi-dimensional back treatment system.
- Page 3 Wetzlarer Str. 41-43 | 35630 Ehringshausen | Germany Tel. +49 (0) 6443 8333 -113 | Fax +49 (0) 6443 8333 -119 export@schwa-medico.de ® We at schwa-medico wish you every success with your StimaWELL 120MTRS System. Dr. Roger Pierenkemper Dr. med. Bertram Disselhoff C.E.O.
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Page 4: Table Of Contents
OPERATING MANUAL STIMAWELL® 120MTRS Contents Important Instructions ___________________________________________________ 6 Purpose Of Use _________________________________________________________ 6 Contra-Indications _______________________________________________________ 6 Side Effects ____________________________________________________________ 6 Safety Instructions_______________________________________________________ 6 Description Of The Symbols _______________________________________________ 8 Technical Description ____________________________________________________ 9 Technical Data __________________________________________________________ 9 Classification __________________________________________________________ 10 Description Of The Product _______________________________________________ 11 Set-Up And First Time Starting ____________________________________________ 13 Preparations For Stimulation _____________________________________________ 14... - Page 5 OPERATING MANUAL STIMAWELL® 120MTRS 12.2.3 Touch Options _________________________________________________________ 53 12.3 Setting The Time _______________________________________________________ 53 12.4 Setting The Date _______________________________________________________ 53 12.5 Selecting The Language __________________________________________________ 54 12.6 Software Update _______________________________________________________ 54 Chip Cards ____________________________________________________________ 55 Therapy With Therapy Cards _____________________________________________ 55 14.1 Creating Therapy Cards __________________________________________________ 55 14.1.1 Saving Existing Patient Profiles On Therapy Cards _____________________________ 56...
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Page 6: Important Instructions
OPERATING MANUAL STIMAWELL® 120MTRS Important Instructions Purpose Of Use ® The StimaWELL 120MTRS System has been designed for the use of medium frequency electro- therapy for muscle stimulation and pain relief therapy as well as for heat treatment, massage and wellness applications in the back region for adults and young persons of comparable body size. - Page 7 OPERATING MANUAL STIMAWELL® 120MTRS ® Please read carefully the operating instructions for the StimaWELL 120MTRS System before using. ® The StimaWELL 120MTRS System is only to be used with original accessories. ® Keep water or other liquids well away from the StimaWELL 120MTRS Control Unit.
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Page 8: Description Of The Symbols
OPERATING MANUAL STIMAWELL® 120MTRS ATTENTION! Particular attention must be paid to the central positioning of the patient on the stimulation mat. The spinous process must be placed in the vertical mat cleft. For safety reasons, application with the StimaWELL® 120MTRS should be carried out under repeated monitoring of patient and device. -
Page 9: Technical Description
OPERATING MANUAL STIMAWELL® 120MTRS By labelling with CE mark, the manufacturer asserts that the product fulfills all relevant requirements of the respective EC Directives. A conformation assessment process has been successfully completed. The identification number in respect of the conformation assessment process is given in accordance with the CE labelling of the relevant notified body. -
Page 10: Classification
OPERATING MANUAL STIMAWELL® 120MTRS Weight Basic control unit ca. 5 kg Stimulation mat ca. 8,5 kg Operating conditions Temperature range 10 °C to 40 °C Relative humidity 30 % to 90 % Air pressure 700hPa to 1060 hPa Storage Conditions Temperature range -10 °C to 55 °C Relative humidity... -
Page 11: Description Of The Product
OPERATING MANUAL STIMAWELL® 120MTRS Description Of The Product View Of The Front Side Of The StimaWELL®120MTRS Display (Touch Screen) Rotary/pressure controller USB slot Chip card insertion slot ® View Of The Rear Side Of The StimaWELL 120MTRS System Mains cable connection ON/OFF switch Connection for remote control plug... - Page 12 OPERATING MANUAL STIMAWELL® 120MTRS Remote Control Intensity increase button Intensity decrease button Stop button ® StimaWELL Stimulation Mat And Accessories ® StimaWELL Stimulation Mat with 12 channels Mat connection plug ® StimaWELL Mat underlay ® StimaWELL Cushion ® StimaWELL Lordosis Cushion Cable holder Leg/foot elevation cube Paper roll as mat overlay...
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Page 13: Set-Up And First Time Starting
OPERATING MANUAL STIMAWELL® 120MTRS Set-Up And First Time Starting The following describes the set-up and first time starting for the ® StimaWELL 120MTRS System: Place the control unit on a smooth, even surface. Please ensure that the ventilation slits are not covered. ®... -
Page 14: Preparations For Stimulation
OPERATING MANUAL STIMAWELL® 120MTRS ® Switch on the StimaWELL 120MTRS Control Unit with the ON/OFF switch which is located on the rear side of the control unit. About 2 seconds after switching on the Sti- ® maWELL 120MTRS Control Unit there appears the start screen. -
Page 15: Operating
OPERATING MANUAL STIMAWELL® 120MTRS Now request your patient to divest the upper body part clothing. Ladies should remove their bras so that the electrode surfaces are not covered. It is possible that trousers should be removed (or pushed down somewhat) so that the lower channels can be used on the buttocks. - Page 16 OPERATING MANUAL STIMAWELL® 120MTRS In the following are first described all the display elements: Menu Bar Button Favourites Recall programs which you have marked as favourites (please see Section 8) Button Program Groups Select program groups and therapy programs (please see Section 7) Button Patient Administration Create and administer patient (please see Section 9)
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Page 17: Setting The Mat Temperature
OPERATING MANUAL STIMAWELL® 120MTRS Button Pause Pause the running therapy Button Stop Stop the running therapy ® Display Representation Of The StimaWELL Stimulation Mat Display of the active channels Display Selected Therapy Program Button Favourites Star Include a program in the favourites list / delete from favourites list Display Patient’s Name Display... -
Page 18: Setting The Stimulation Time
OPERATING MANUAL STIMAWELL® 120MTRS Setting The Stimulation Time Setting the therapy duration time functions in the same way as for setting the mat temperature. But please note that the therapy duration can only be changed when no therapy program is running. To set, touch the display Stimulation Time and set the therapy... -
Page 19: Changing View
OPERATING MANUAL STIMAWELL® 120MTRS Changing View If your patient is experiencing the electrical current on individual channels as being too powerful or too weak, you can, during the therapy, select individual channels and set their proportional intensity. However, it is recommended to use Changing View only for fine tuning during the therapy and after you have already implemented a cali-... - Page 20 OPERATING MANUAL STIMAWELL® 120MTRS The display Representation Of ® The StimaWELL Stimulation shows which channels are currently actively stimulating during a running stimulation. The active channels are indicated by an orange coloured marker. This enables you to follow the progression of the stimulation wave. With the button Pause you put the stimulation on hold and the intensity reverts to 0.
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Page 21: Programs
OPERATING MANUAL STIMAWELL® 120MTRS Programs ® The programs of the StimaWELL 120MTRS System are sub-divided into four pro- gram groups: Pain Therapy (based on indications) – programs for the treatment of specific back complaints and pain. Muscle Therapy – programs for the strengthening of the back musculature and for the treatment of tension. Dynamic Deep Massage –... -
Page 22: Program Selection
OPERATING MANUAL STIMAWELL® 120MTRS Program Selection Please note that as a general rule the selection of a therapy program is only then possible ® providing stimulation with the StimaWELL 120MTRS System is not in operation. Touch on the button Programs in the menu bar of the main menu. -
Page 23: Favourites
OPERATING MANUAL STIMAWELL® 120MTRS Favourites ® In the StimaWELL 120MTRS Control Unit you can also create a favourites list to which can be assigned frequently used and particularly popular programs lists. To assign/delete a program to/from the favourites list, touch on the selected program on the button Favourites Star right, adjacent to the program name. -
Page 24: Patient Profiles
OPERATING MANUAL STIMAWELL® 120MTRS Patient Profiles ® The StimaWELL 120MTRS provides the option to create a personal profile for each patient and in which the individual system settings are saved. Here you can save the mat size, the stimula- tion time and therapy programs and, in particular, the proportional intensity levels for the individual stimulation channels which have been denominated by the calibration procedure. -
Page 25: Inputting Patient Data
OPERATING MANUAL STIMAWELL® 120MTRS 9.2.1 Inputting Patient Data As soon as you have activated the button Create A New Patient, there opens a window for the input of patient data. In addition to the name of a new patient data set you can also add optional data such as address, date of birth and insurance details. -
Page 26: Setting The Mat Size
OPERATING MANUAL STIMAWELL® 120MTRS will be cancelled by touching on the button Delete . With the input is confirmed and with Cancel you exit the input field without having implemented the changes. To input a size or a weight please touch on the arrow fields left and right of the respective field. - Page 27 OPERATING MANUAL STIMAWELL® 120MTRS The calibration is very important for the following reasons: A particular stimulation intensity is experienced differently on various parts of the body. For this reason the level of intensity ® sensed on individual channels of the StimaWELL Stimulation Mat is not identical.
- Page 28 OPERATING MANUAL STIMAWELL® 120MTRS You can see the actual set main intensity in the display Intensity. At which proportional of the set intensity is being effectively stimulat- ed on a particular channel can be deduced from the numbers between the two bars of each channel.
- Page 29 OPERATING MANUAL STIMAWELL® 120MTRS If your patient is happy with the set intensity level you can, by touching the right hand arrow or by depressing the rotary/pressure controller, change to the next channel. Alternatively, you can directly select a channel by touching one of the two bars in respect of the required chan- nel.
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Page 30: Selecting The Therapy Mode
OPERATING MANUAL STIMAWELL® 120MTRS Deviations in the intensity values of two opposing longitudinal channels can, in Please Note: some circumstances, necessitate more intensive diagnosis or greater attention to the therapy and the program selection process. 9.2.4 Selecting The Therapy Mode Having completed the calibration you can now decide if you want to carry out the therapy for your patient in the mode Automatic Program Selection Based On Indications... - Page 31 OPERATING MANUAL STIMAWELL® 120MTRS 9.2.4.1.1 Therapeutic Measures “Pain Therapy” Touch on the button Pain Therapy, to input the anamnestic data. You can now select the progression form of the illness causing the pain for your patient (Acute or Chronic). Then input the localisa- tion.
- Page 32 OPERATING MANUAL STIMAWELL® 120MTRS cally selected program, touch on Info. With Close you can close the detailed description and return to the window Therapy Notes. If the help text has been de-activated the main menu opens directly and the automatically specified program for the therapy session for this particular patient is recalled.
- Page 33 OPERATING MANUAL STIMAWELL® 120MTRS 9.2.4.1.3 Therapeutic Measures “Dynamic Deep Massage” Touch on the button Dynamic Deep Massage. Now select the type of Dynamic Deep Mas- sage you wish to perform. The following options are available for selection: Gentle Deep Waves, Intensive Deep Waves Specific Deep Waves.
- Page 34 OPERATING MANUAL STIMAWELL® 120MTRS Select Better, Same Worse by touch- ing and confirming with the button Con- firm. Your patient remains “selected” so that you can use the button Evaluation, for example to view the evaluation of the actual therapy. To recall, after the therapy session, the profile Basic Setting, you can activate the button Main Menu...
- Page 35 OPERATING MANUAL STIMAWELL® 120MTRS Mark by touching on the required program package in the list. With the button Info there opens a menu in which the programs contained in the package/your favourites are displayed. There you can again with the button Info generate a display of a program description for the marked program.
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Page 36: Selecting A Patient For Therapy
OPERATING MANUAL STIMAWELL® 120MTRS Selecting A Patient For Therapy Once you have selected in the main menu Patient Administration, touch on menu point Select Patient/Edit Data, to call up a list with of existing patient profiles. You can select patients for therapy or edit patient data here. - Page 37 OPERATING MANUAL STIMAWELL® 120MTRS Select Manual Single Session, if you wish to perform an individual session in Manual mode, without interrupting the previous therapy cycle. This can typically be used if your patient is presently in a therapy cycle Pain Therapy and would like to undergo a Dynamic Deep Massage for relaxation.
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Page 38: Previous Therapy In The Mode "Manual Program Selection
OPERATING MANUAL STIMAWELL® 120MTRS 9.3.1.2 Starting New Therapy Cycles After touching the button Start New Therapy Cycle decide if you wish to carry out a new cali- bration or start the therapy with the old calibration. Touch on Perform New Calibration, to perform a side-differentiated calibration again. - Page 39 OPERATING MANUAL STIMAWELL® 120MTRS 9.3.2.1 Continuing In The Mode “Manual Program Selection” Touch on Continue With Manual Program Selection, to continue with the next program in the program list which you have assigned to the patient. With patients in the mode Manual Pro- gram Selection you have at all times the option to manually select alternative programs for...
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Page 40: Editing Patient Data
OPERATING MANUAL STIMAWELL® 120MTRS Editing Patient Data After you have selected in the main menu the Patient Administration, touch on the menu ® point Select Patient/Edit Data. A list of all the saved patients in the StimaWELL 120MTRS Control Unit is displayed. You mark a patient by touching on the name. The letter field on the right hand border can be used for jumping (by touching on the first letter of the required name). -
Page 41: History Evaluation
OPERATING MANUAL STIMAWELL® 120MTRS When you mark a patient and touch on OK, you select the patient for therapy (please see Section 9.3). With Cancel you return to Patient Administration without having implemented the changes. If you wish to change the mat size, with selected patient data set touch in the Please Note: ®... -
Page 42: Button "Evaluation
OPERATING MANUAL STIMAWELL® 120MTRS The pain tendency pictogram shows at which denominated value the pain level has changed since the start of the therapy. A negative value (-) shows an improvement in the pain level and a positive value shows a deterioration. The actual pain level which the patient selected before the start of the current therapy session is used for the calculation of this pain level. -
Page 43: 10 Setting The Proportional Intensity
OPERATING MANUAL STIMAWELL® 120MTRS 10 Setting The Proportional Intensity If, during the therapy session, your patient senses the intensity on individual chan- nels as being too powerful or too weak you can select individual channels and set their proportional intensity. For this, touch in the menu bar of the main menu on the button Changing View. - Page 44 OPERATING MANUAL STIMAWELL® 120MTRS Detailed Display Longitudinal Stimulation Detailed Display Lateral Stimulation...
- Page 45 OPERATING MANUAL STIMAWELL® 120MTRS If you wish to permanently change the basic settings, set as user “Basic Setting” (please see Section 9.3) and insert your admin card in the chipcard slot. By means of the sliding controllers now change the proportional intensity and then touch in the menu bar on the button Save...
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Page 46: 11 User Programs
OPERATING MANUAL STIMAWELL® 120MTRS 11 User Programs ® You have the option in the StimaWELL 120MTRS System to create own therapy programs. These so-called “User Programs” can be composed according to your own specific requirements from a list of elements which we characterise in the following as sequences. -
Page 47: 12 Settings
OPERATING MANUAL STIMAWELL® 120MTRS Exceptions: Sequences of type Bubbles not contain waves therefore no wave direc- tion can be specified. With sequences of type Lindworm the waves flow in the specified direction left or right around the spine so here it is also not possible to specify a wave direction. -
Page 48: Evaluating And Administering The Database
OPERATING MANUAL STIMAWELL® 120MTRS 12.1 Evaluating And Administering The Database With the menu point Database you can evaluate and administer the database. 12.1.1 Evaluating The Database Touch in the menu Database the menu point Evaluation, to evaluate totally the patient ®... -
Page 49: Administering The Database
OPERATING MANUAL STIMAWELL® 120MTRS In the upper area you see the filters you have selected. In the distinct area below is dis- played the results of the evaluation. You find firstly here the number of patients for whom the filter is applicable sorted by sex. Then you see the number of individual therapy sessions (including time periods) which these patients have completed. - Page 50 OPERATING MANUAL STIMAWELL® 120MTRS ® If you copy the database of your StimaWELL 120MTRS Control Unit to a USB Please Note: flash drive on which patient data already exists this can lead to an error in the data sets. It is therefore important to ensure that the flash drive contains no other patient data.
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Page 51: Setting The Options
OPERATING MANUAL STIMAWELL® 120MTRS 12.1.2.4 Deleting USB Flash Drive If you wish to delete the patient database from a USB flash drive, please insert the flash drive in the USB slot and touch on Drive. The patient data on the USB flash Delete From Flash drive will now be deleted. -
Page 52: Technical Options
OPERATING MANUAL STIMAWELL® 120MTRS 12.2.2 Technical Options By touching on the selection field Standard Intensities all changes you have carried out regarding the proportional intensities in the basic settings are annulled. The proportional intensities are reset to the status on delivery. Activate or de-activate the remote control unit via the selection field Remote Control... -
Page 53: Touch Options
OPERATING MANUAL STIMAWELL® 120MTRS Please note that you can only delete a patient data record if you remove it from the data- base of each of your StimaWELL®120MTRS devices. Otherwise it will be created again when importing from one device to another. 12.2.3 Touch Options Activate the Option... -
Page 54: Selecting The Language
OPERATING MANUAL STIMAWELL® 120MTRS 12.5 Selecting The Language Select the required operating language by touching the respective selection field and confirm your selection with OK. Please note that with a change of language the Sti- ® maWELL 120MTRS System must be restarted. With Cancel you exit the menu without having... -
Page 55: 13 Chip Cards
OPERATING MANUAL STIMAWELL® 120MTRS If a Firmware Update for the control of the 12 stimulation channels and/or the tempera- ture control is required, the window for its update will now open. You must download this update before the system is again opera- tional. -
Page 56: Saving Existing Patient Profiles On Therapy Cards
OPERATING MANUAL STIMAWELL® 120MTRS Set, via the arrow fields left and right adjacent to the displays, the number of booked therapy sessions and the therapy time. Touch on the button Package, if you wish to select for your patient a program package. A program package comprises 5 programs, each of which can be present more than once. -
Page 57: Therapy With Therapy Cards
OPERATING MANUAL STIMAWELL® 120MTRS Continue as for the programming of therapy cards. But please note here that the number of the therapy sessions on the card can on occa- sion exhibit a value of 0 and must be set by you before the data can be saved to the ther- apy card. -
Page 58: Selecting The Therapy Program
OPERATING MANUAL STIMAWELL® 120MTRS 14.2.1 Selecting The Therapy Program You can select between the thera- py programs saved on the therapy card. After the insertion of the card, the number of the actual session rela- tive to the program is selected. For the selec- tion of a program, use the button Programs, to have displayed the complete program list of your patient and to select a program from... -
Page 59: Editing Or Deleting Therapy Cards
OPERATING MANUAL STIMAWELL® 120MTRS After expiry of the therapy time, the therapy is automatically terminated. Please note that after expiry of the therapy session no further sessions can be started. There appears the prompt for the removal of the card on which are displayed the remaining number of applications. -
Page 60: 15 General
OPERATING MANUAL STIMAWELL® 120MTRS 15 General 15.1 Warranty The customary legal rights in accordance with BGB apply. 15.2 Guarantee During the guarantee period of two years beginning from the date of purchase, any repairs will be carried out free of charge providing such repairs have not been necessitated by im- proper operation of the control unit. -
Page 61: Combination With Original Accessories
OPERATING MANUAL STIMAWELL® 120MTRS 15.6 Combination With Original Accessories ® Within the auspices of the CE identification as a medical product, the StimaWELL 120MTRS is to be operated exclusively in combination only with accessories listed in the operating instruc- tions. Otherwise, we cannot guarantee patient safety, operating personnel safety nor the control unit itself. -
Page 62: 16 Manufacturer's Declaration
OPERATING MANUAL STIMAWELL® 120MTRS 16 Manufacturer's declaration Guidelines and manufacturer's declaration – electromagnetic emission The StimaWELL®120MTRS device is designated for operation in an environment as stated below. The customer or the operator of the StimaWELL®120 MTRS should ensure that it is operated in such an envi- ronment. - Page 63 OPERATING MANUAL STIMAWELL® 120MTRS Guidelines and manufacturer's declaration – electromagnetic interference resistance The StimaWELL®120MTRS is designated for operation in the electromagnetic environment stated below. The customer or the operator of the StimaWELL®120MTRS should ensure that it is operated in such an environment.
- Page 64 OPERATING MANUAL STIMAWELL® 120MTRS Magnetic field at Magnetic fields at mains frequency supply frequency should correspond to the typical 3 A/m 3 A/m (50/60 Hz) as per values found in a commercial and IEC 61000-4-8 hospital environment. NOTE is the mains a.c. voltage prior to application of the test level Guidelines and manufacturer's declaration –...
- Page 65 OPERATING MANUAL STIMAWELL® 120MTRS NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines may not be applicable in all cases. The spread of electro- magnetism is influenced by absorption and reflection from buildings, objects and people The field strength of stationary transmitters, such as base stations for mobile tele- phones and mobile land lines, amateur radio stations, AM- and FM radio and television stations cannot be previously determined, in theory.
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- Page 68 DEUTSCHLAND schwa-medico Medizinische Apparate Vertriebsgesellschaft mbH Wetzlarer Str. 41 - 43 I 35630 Ehringshausen Tel. 06443 8333-110 I Fax 06443 8333-119 info@schwa-medico.de I schwa-medico.de I schwa-medico.com ÖSTERREICH schwa-medico Handelsgesellschaft m.b.H. Industriezeile 25 I 5280 Braunau Tel. 07722 66122 I Fax 07722 66123 info@schwa-medico.at I schwa-medico.at...