Physiomed Deep Oscillation Personal User manual

Personal
OPERATING INSTRUCTIONS
REFERENCE NUMBER: 00949 GB
COPYRIGHT© PHYSIOMED ELEKTROMEDIZIN AG

Legal Notice
Distribution, reproduction and translation of the software and its documentation (or excerpts thereof) are
prohibited without the prior written consent of PHYSIOMED ELEKTROMEDIZIN AG.
PHYSIOMED ELEKTROMEDIZIN AG reserves the right to change the software and associated data as well
as the documentation without notice. All other rights reserved.
PHYSIOMED ELEKTROMEDIZIN AG
Hutweide 10
D-91220 Schnaittach/Laipersdorf (Germany)
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Internet: http://www.physiomed.de
DEEP OSCILLATION®Personal is a registered trademark of PHYSIOMED ELEKTROMEDIZIN AG. The therapy
mode has been patented worldwide.
DEEP OSCILLATION®Personal is made in Germany in compliance with the quality requirements of EN ISO
13485:2003+AC:2007, EN ISO 9001:2008 and the applicable safety standards and regulations of the
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
The compliance with the regulations mentioned here is indicated by the CE label on the instrument. The
declaration of conformity might be requested from the manufacturer at the address given above.
A conformity check acc. to Annex II, approved by the notified body 1275, was carried out.
Last updated on July 12, 2010.

Table of Contents
Chapter1 Introduction.................................. 1
1.1 ConventionsUsed.................................1
1.2 GeneralNotes...................................1
1.3 InstrumentOverview ...............................3
1.4 SymbolsintheDisplay...............................4
1.5 InstrumentDescription ..............................4
1.6 Application ....................................4
1.7 Contraindications.................................5
Chapter 2 Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Function of Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1.1 Display<1>....................................6
2.1.2 DataSelector<2>.................................6
2.1.3 Ports<3>.....................................7
2.1.4 CardReader<4> .................................7
2.1.5 Battery Compartment <5> . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1.6 ControlLight<6>.................................7
2.1.7 ChargerSocket<7>................................7
Chapter 3 Instrument Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1 BatteryOperation.................................8
3.1.1 Important Notes on Handling the Batteries . . . . . . . . . . . . . . . . . . . . 8
3.1.2 BatteryCharger..................................9
3.1.3 EconomyMode................................. 10
3.2 Preparations and Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3 FunctionCheck................................. 11
3.4 CableCheck................................... 12
3.5 HandApplicator................................. 12
3.6 TherapyCard .................................. 13
3.7 InstrumentErrors................................ 14
Chapter4 Treatment...................................15
4.1 Treatment with the Hand Applicator . . . . . . . . . . . . . . . . . . . . . . 15
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AppendixA Appendix ...................................18
A.1 Service, Repairs, Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 18
A.2 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
A.3 Service Life and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
A.4 Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . 19
A.5 BasicSettings.................................. 19
A.6 TechnicalData.................................. 20
A.7 Training..................................... 21
Appendix B Scope of Delivery and Accessories . . . . . . . . . . . . . . . . . . . . 22
B.1 ScopeofDelivery................................ 22
B.2 AvailableAccessories.............................. 22
Appendix C Supplementary Documents . . . . . . . . . . . . . . . . . . . . . . . . 24
C.1 Manufacturer's Recommendations . . . . . . . . . . . . . . . . . . . . . . . 24
Index......................................25
Table of Contents PHYSIOMED ELEKTROMEDIZIN AG
ii DEEP OSCILLATION®Personal

Chapter 1 Introduction
With DEEP OSCILLATION®Personal you have acquired an extremely versatile deep oscillation system. The
instrument will only show its true potential, however, if you are well informed about its functions. For this
reason, carefully read these Operating Instructions and familiarise yourself with the use of the instrument.
1.1 Conventions Used
Please note the following typographical conventions in these Operating Instructions:
• Cross references and important terms used for the first time in this document are written in italics.
• Names of menus and symbols on the display are written in bold typeface.
Paragraphs that deserve special attention are highlighted in the following way:
Symbol Type Meaning
Tip Intended to give you some extra hints for more convenient operation
Note Provides background information for better understanding
Important Prevents misunderstandings that might lead to limited operation of the in-
strument or insufficient therapeutical results
Caution Alerts you in cases of possible damage to the instrument or risks of injury
1.2 General Notes
The instrument may only be operated in dry rooms. It complies with the technical specifications of IEC
60601, VDE 0750 and is assigned to class IIa according to the Council Directive 93/42/EEC concerning
Medical Devices.
It is not intended for operation in explosion hazard zones or hydrotherapy rooms. Drastic temperature
changes should be avoided, since condensation could be caused within the instrument. Do not start up
the instrument until it is in thermal equilibrium with its environment!
The instrument is to be operated properly, i.e. in accordance with the Operating Instructions. Operating
the instrument in the proximity (e.g. 1 m) of a short-wave or micro-wave therapy unit may cause output ir-
regularities and should be avoided for this reason, as well as simultaneous connection of the patient to
high-frequency surgical instrument.
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction
DEEP OSCILLATION®Personal 1

1.3 Instrument Overview
Front Panel Rear Face (Back Cover removed)
Legend
1 Display 4 Card Reader
2 Data Selector 5 Battery Compartment
3 Ports 6 Control Light
7 Charger Socket
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Rear Face (with Back Cover) Carrying Case (Front and Rear Face)
Bottom
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1.4 Symbols in the Display
You find the following symbols in the Display <1>:
Battery Indicator (refer to Battery Operation on page 8)
Setup Menu (refer to Basic Settings on page 19)
Confirm Settings
Contrast of the Display <1> (refer to Basic Settings on page 19)
Bar View (Contrast, Intensity), here e.g. 50%
Button Back
Indications Menu
Page Selection for Information Pages
Position Marker, here: Page 1 of 3
Therapy Parameters (Therapy Time, Therapy Frequency, Therapy Phase)
Timer Symbol (to Adjust the Therapy Time)
1.5 Instrument Description
DEEP OSCILLATION®Personal is a deep oscillation system which is successfully used in various areas of
medicine. For the individual areas, special chipcards are available.
DEEP OSCILLATION®Personal has two modes of operation:
•Treatment: In this mode, the instrument is separated from the mains. When the battery charger is
plugged in, the instrument cannot be switched on and treatment can not be continued. Connecting
the battery charger with the mains will reduce the instensity automatically to zero, treatment will be
interrupted, and the instrument will be switched off.
•Charging: While charging, treatment is not possible.
Caution
During the charging procedure, the patient must neither be connected with the titanium
neutral element, nor with the hand applicator!
1.6 Application
The function of DEEP OSCILLATION®Personal is based on a pulsed electrostatic field which is built up in
the patient's body region to be treated. Its frequency changes between 5 - 250 Hz, according to the selec-
ted indication. Due to the movement of the hand applicator, a vibrating or pumping effect with deep im-
pact is induced in the patient's tissue.
Treatment with DEEP OSCILLATION ®Personal has the following positive effects on the treated tissue:
• trophic enhancement
1 Introduction PHYSIOMED ELEKTROMEDIZIN AG
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• muscle relaxation
• pain reduction
• edema reduction
• inhibition of inflammations
• enhancement of wound healing
1.7 Contraindications
Therapy with DEEP OSCILLATION®Personal is not indicated in the following cases:
• acute infections
• acute inflammations with participation of pathogenic agents
• active tuberculosis
• acute venous diseases (untreated thromboses)
• untreated malignant processes
• erysipelas
• patients and therapists with cardiac pacemakers and other electronic implants
• heart disorders and diseases, especially cardiac insufficiency, decompensated cardiac edema, and car-
diac arrhythmia
• pregnancy
• hypersensitivity to electrostatic fields
• infectious skin diseases
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DEEP OSCILLATION®Personal 5

Chapter 2 Controls and Indicators
The design of DEEP OSCILLATION®Personal allows for easy operation, in combination with a variety of
functions. Because of its small size, the instrument is very easy to transport. It has been designed for oper-
ation also outside of therapy rooms, and is fed by rechargeable batteries for that reason.
All controls and indicators are integrated into the housing, thus allowing for easy cleaning of the instru-
ment's surface and protecting it from dust.
The instrument's microprocessor monitors the safety-related components, prevents from erroneous opera-
tion and checks the instrument after switching it on.
2.1 Function of Controls and Indicators
The following section introduces the individual indicators and controls of DEEP OSCILLATION®Personal.
The numbers in angle brackets refer to the Instrument Overview on page 3.
2.1.1 Display <1>
Display <1>
In the Display <1> the available options or therapy
parameters are shown, depending on the context.
The battery symbol on the bottom left shows you
the current state of charge of the batteries (also
refer to Battery Operation on page 8).
You can select a parameter using the Data Select-
or <2>.
2.1.2 Data Selector <2>
Data Selector <2>
The Data Selector <2> serves to select the therapy parameters shown
in the Display <1> as well as to adjust the intensity.
You can switch between the individual options by rotating the selector
and call the respective function by pressing it.
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2.1.3 Ports <3>
Ports <3>
The Ports <3> serve to connect the supplied cables for the hand applic-
ator and the adhesive or neutral electrode with the instrument.
You can find instructions on how to connect the cables in section How
to Prepare Treatment on page 15.
2.1.4 Card Reader <4>
Card Reader <4>
The Card Reader <4> serves to insert the therapy card which en-
ables access to the user menus, and on which the therapy para-
meters are stored. The therapy card has to be inserted with with
the chip side facing down.
2.1.5 Battery Compartment <5>
Battery Compartment <5>
The Battery Compartment <5> receives the re-
chargeable batteries and connects them with the instru-
ment. It is protected by a rear cover made of metal,
which is attached to the instruments housing by three
magnets.
2.1.6 Control Light <6>
The Control Light <6> under the Data Selector <2> is on as soon as the intensity is being increased. In
case of low therapy frequency, the light is flashing in sync with the pulses. When the electrostatic field is
cut short, the light goes out even with non-zero intensity. The Control Light <6> can also be used to
check the cables (refer to Cable Check on page 12).
2.1.7 Charger Socket <7>
The Charger Socket <7> can be found on the bottom of the instrument. The sup-
plied battery charger (Ref.-No. 00277) to charge the batteries is plugged in here.
PHYSIOMED ELEKTROMEDIZIN AG 2 Controls and Indicators
DEEP OSCILLATION®Personal 7

Chapter 3 Instrument Operation
3.1 Battery Operation
DEEP OSCILLATION®Personal uses rechargeable 1.2 V AA NiMH batteries for power supply, which allow
for operation independently from the mains.
In order to ensure a long life, the battery must be charged completely when first charged. The first char-
ging procedure should not be interrupted.
The charging status of the batteries is displayed on the Display <1>:
Battery completely charged
If the battery capacity is very low during operation, the 3-step warning system is activated:
(a) The charging status symbol flashes.
(b) An acoustic signal sounds every second and the charging status symbol flashes. The intensity is re-
duced prematurely.
(c) The instrument shuts down to avoid complete discharging of the batteries.
In this case, recharge the batteries.
How to Recharge the Batteries
Caution
During the charging procedure, the patient must neither be connected with the titanium
neutral element, nor with the hand applicator!
Note
As an alternative to the charging procedure directly on the instrument described here,
you can also remove the batteries from the instrument (as described in How to Replace
the Batteries on page 9) and charge them with the supplied battery charger.
(1) Plug the supplied battery charger into the Charger Socket <7> on the bottom of the instrument.
The batteries will be charged.
(2) Unplug the battery charger from the instrument when the charging procedure is finished.
3.1.1 Important Notes on Handling the Batteries
Rechargeable batteries discharge over an extended period, even if the instrument is switched off. To pre-
vent from this self-discharge process, the batteries should be removed from the instrument.
If the instrument is not in use for a longer period of time, the batteries have to be entirely charged before
storage. Remove the batteries from the instrument then.
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8 DEEP OSCILLATION®Personal

If the unit is not used for a longer period of time, please fully charge the battery at least once every two
months. This will help to avoid exhaustive discharge, which may permanently affect the battery life, not
enabling it to be recharged; hence, replacement will be necessary.
How to Replace the Batteries
Batteries that can no longer be recharged can be replaced by fresh ones:
(1) Ensure that the instrument is switched off.
(2) Hold the instrument with the rear face up and remove the back cover. The back cover is held by
three magnets.
(3) Remove the four rechargeable batteries from the instrument.
(4) Insert the fresh batteries into the Battery Compartment <5> of your DEEP OSCILLATION®Personal
Ensure that the polarity is correct and the removal strip is placed below the batteries!
Important
Dispose rechargeable batteries with care and respect the legislation with respect to en-
vironment protection.
3.1.2 Battery Charger
The supplied battery charger (Ref. No. 00277) has an LED to indicate the current state of the batteries.
Battery Charger
Charging Cycle and LED Readings
LED Mode
Yellow Battery not connected
Yellow Battery initialization and analysis
Orange Quick charge mode
Green with yellow flashing light Intermediary mode with low charging voltage
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LED Mode
Green Maintenance charge mode
Flickering orange - green alternately Error
The Instrument Should not Be Stored with the Charger Plugged in
If the instrument is stored with a plugged in charger, the battery discharges faster, since a dis-
charge current also flows through the charger. This reduces the above mentioned timespan
up to the excessive discharge of the battery.
Note
The battery charger can be equipped with different primary adaptors to match the line
voltage of the destination country. One primary adaptor for the respective country is in the
scope of delivery. Refer to Available Accessories on page 22 for available primary adaptors.
Please find more information on the operation of the battery charger in the supplied operating instruc-
tions.
3.1.3 Economy Mode
The unit automatically switches over to the economy mode to save power. This will occur after approx. 20
seconds. The Display <1> is no longer illuminated. Pressing any key will re-activate the illumination.
3 Instrument Operation PHYSIOMED ELEKTROMEDIZIN AG
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3.2 Preparations and Start-Up
How to Start up the Instrument
(1) Press the Data Selector <2> for one second. You will hear an acoustic signal and the Display <1> is
illuminated. The message No CARD available in the unit! Please insert CARD. is displayed.
(2) Insert your card with the chip side facing down into the Card Reader <4>. The welcome screen is
displayed.
Note
If the card is defective or incompatible, a respective error message will be displayed.
(3) Click the symbol. The indications menu is displayed.
Indications Menu
You can now select an indication and begin treatment (refer to How to Perform a Treatment on
page 15).
How to Switch off the Instrument
(1) Press the Data Selector <2> for five seconds. The Display <1> goes out.
(2) Remove the therapy card and unplug the cables from the Ports <3>.
3.3 Function Check
A function check is always necessary when you are unsure about whether the instrument is working prop-
erly.
How to Check the Function of the Instrument
(1) Press the Data Selector <2> for several seconds until the instrument switches off.
(2) Press the Data Selector <2> again until the instrument switches on:
• If the instrument is properly working, the available options are displayed on the Display <1>.
You can operate the instrument without any further precaution.
• If an error code is displayed, there is an instrument error. Proceed as described under Instru-
ment Errors on page 14 .
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3.4 Cable Check
If you should have the impression that a cable is defective during treatment, you can check it using the in-
strument.
How to Check a Cable
(1) Select a therapy and set the intensity to 100% using the Data Selector <2>.
(2) Plug the ends of the cable to be tested into the Ports <3>.
(3) Move the cable and pay attention to the Control Light <6> under the Data Selector <2>:
• The Control Light <6> is permanently on: The cable is defective.
• The Control Light <6> is off: The cable is OK.
• The Control Light <6> flashes when moving the cable: The cable is defective.
(4) Replace the defective cable immediately.
3.5 Hand Applicator
The hand applicator consists of the following parts:
Hand Applicator (Exploded View)
(1) Handle (Ref.-No. 00379)
(2) Cover
(3) Oscillator Plate
(4) Membrane
(5) Clamp Ring
Note
(2) - (5) make up the oscillator head in
the respective size.
The oscillator head is screwed into the handle. To remove the head from the handle, you have to rotate it
to the left.
Important
Any damage to the oscillator membrane might lead to harmless (but unpleasant) sensations
on the skin.
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12 DEEP OSCILLATION®Personal

Replace the membrane immediately if damaged!
How to Replace the Membrane
(1) Take off the clamping ring and remove the membrane.
(2) Insert the new membrane with the foil facing down loosely into the clamping ring, so that the mem-
brane foil protrudes laterally.
Changing the Membrane - Inserting
(3) Press the oscillator plate firmly onto the foam rubber area of the membrane until the clamping ring
engages with the oscillator plate. Make sure that the foil is tightly fixed with the clamping ring on the
outside, and that the clamping ring is engaged!
Changing the Membrane - Engaging the Oscillator Plate
3.6 Therapy Card
All indications available for DEEP OSCILLATION®Personal are stored on the therapy card. The therapy card
must be inserted to perform a treatment or to access the basic settings.
Caution
The treatment card must not be copied, and any attempt to reproduce it or read out the data
will invalidate it! PHYSIOMED ELEKTROMEDIZIN AG accepts no responsibility for damage in-
curred in this way!
PHYSIOMED ELEKTROMEDIZIN AG 3 Instrument Operation
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3.7 Instrument Errors
If a functional error is detected during the automatic selftest routine or operation, one of the following er-
ror codes is shown on the Display <1>:
•ERROR_01 ... ERROR_05
In this case, treatment is automatically interrupted. Switch off the instrument by pressing the Data Select-
or <2> and switch it on again. If the error code persists even after several selftests, you have to consult
the technical service.
3 Instrument Operation PHYSIOMED ELEKTROMEDIZIN AG
14 DEEP OSCILLATION®Personal

Chapter 4 Treatment
With DEEP OSCILLATION®Personal you can perform treatments according to preset indications which are
stored together with the corresponding therapy parameters on the therapy card. For each displayed indic-
ation you can refer to the recommended therapy instructions. Each indication features an image of a body
region to be treated, which shows the preferable direction of treatment.
Caution
Before each treatment, adjust the intensity to match the respective conditions and pay atten-
tion to the contraindications (refer to Contraindications on page 5)!
During the charging procedure, the patient must neither be connected with the titanium
neutral element, nor with the hand applicator!
4.1 Treatment with the Hand Applicator
How to Prepare Treatment
(1) Before treatment, prepare the patient's skin area to be treated by drying or powdering.
(2) Plug in the cables for the hand applicator as well as for the Titanium neutral element (ref.-no. 00382)
into the Ports <3>. The instrument operates in biphase mode; therefore, you don't have to pay at-
tention to the polarity.
(3) Connect the Titanium neutral element with the other end of the cable and let the patient grip it. Al-
ternatively, you can attach it on any part of the patient's body.
(4) Connect the applicator to the appropriate cable.
How to Perform a Treatment
(1) Start up the instrument as described under How to Start up the Instrument on page 11.
(2) Select an indication from the indications menu. The therapy parameters of the selected indication are
displayed.
Therapy Instructions - Parameters
(3) Click the symbol. Instructions on how to perform the treatment are shown.
PHYSIOMED ELEKTROMEDIZIN AG 4 Treatment
DEEP OSCILLATION®Personal 15

Therapy Instructions - Text
(4) Rotate the Data Selector <2> until the symbol flashes. An image showing a body area to be
treated as well as the treatment direction is displayed.
Therapy Instructions - Image
(5) Click the symbol. The preset therapy parameters are displayed.
Treatment
(6) Click the symbol and set the desired intensity by rotating the Data Selector <2>. As soon as
the intensity is set, treatment begins, the therapy time elapses, and the Control Light <6> under the
Data Selector <2> is on.
In the example shown here, treatment with two different therapy phases is performed. Perform the
treatment and pay attention to the therapy instructions shown before.
In the case of treatments with more than one phase, therapy parameters are automatically switched
after the end of the first therapy phase. As soon as the time for the last treatment phase has elapsed,
the intensity decreases to zero. You can now perform one more treatment, or switch off the instru-
ment.
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16 DEEP OSCILLATION®Personal