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
PHYSIOMED ELEKTROMEDIZIN AG Table of Contents
DEEP OSCILLATION®Personal i

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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DEEP OSCILLATION®Personal 3

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
4 DEEP OSCILLATION®Personal

• 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
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction
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.
2 Controls and Indicators PHYSIOMED ELEKTROMEDIZIN AG
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