Physiomed IONOSON-Basic User manual

01750 GB
OPERATING INSTRUCTIONS
IONOSON-Basic
MAINS-OPERATED MODEL
BATTERY-OPERATED MODEL

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
IONOSON-Basic 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 December 10, 2010

Table of Contents
Chapter1 Introduction.................................. 1
1.1 ConventionsUsed.................................1
1.2 InstrumentSymbols................................1
1.3 InstrumentOverview ...............................2
1.4 GeneralNotes...................................3
1.5 InstrumentDescription ..............................3
1.6 Application ....................................4
1.7 Contraindications.................................4
Chapter 2 Controls and Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.1 Display<1>....................................6
2.1.1 Symbols in the Display <1> . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.2 DataSelector<2>.................................7
2.3 Intensity Control Channel 1 <3> and Channel 2 <4>. . . . . . . . . . . . . . . 7
2.3.1 Automatic Output Current Switch-off. . . . . . . . . . . . . . . . . . . . . . . 7
2.4 Patient Current Indicator <5> . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5 OutputIndicator<6>...............................8
2.6 MainsModule<7>................................8
2.7 PowerSwitch<8>.................................9
2.8 Patient Lead Connector <9> . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.8.1 Patient Lead: Mode of Attachment . . . . . . . . . . . . . . . . . . . . . . . . 9
2.9 Ultrasound Lead Connector <10>. . . . . . . . . . . . . . . . . . . . . . . . . 9
2.10 Manual Release Key Socket <11> . . . . . . . . . . . . . . . . . . . . . . . . 10
Chapter 3 Overview of Current Modes . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 Settings for all Current Modes . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 DualChannelOperation............................. 11
3.2.1 Simultaneous and Alternating Stimulation . . . . . . . . . . . . . . . . . . . 12
3.3 Low-Frequency Current Modes . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3.1 (G)Galvanization................................ 15
3.3.2 (GMC) Galvanization with Microcurrent . . . . . . . . . . . . . . . . . . . . 16
3.3.3 (DF) Diadynamic Current Diphasé Fixe . . . . . . . . . . . . . . . . . . . . . 17
3.3.4 (MF) Diadynamic Current Monophasé Fixe . . . . . . . . . . . . . . . . . . . 18
3.3.5 (CP) Diadynamic Current Modulé en Courtes Périodes . . . . . . . . . . . . . 18
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3.3.6 (LP) Diadynamic Current Modulé en Longues Périodes . . . . . . . . . . . . . 19
3.3.7 (UR) Ultra Stimulation Current. . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.3.8 (HV) High-Voltage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.3.9 (TENS) Transcutaneous Electric Nerve Stimulation. . . . . . . . . . . . . . . . 23
3.3.10 (MENS) Electric Nerve Stimulation with Microcurrent . . . . . . . . . . . . . . 24
3.3.11 (IG30) Pulse Galvanization 30 . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.3.12 (IG50) Pulse Galvanization 50 . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.3.13 (FM) Frequency-Modulated Current. . . . . . . . . . . . . . . . . . . . . . . 27
3.3.14 (STOCH) Stochastic Current . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.3.15 (FaS) Faradic Surge Current . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.3.16 (T/R) Pulses with Adjustable Parameters. . . . . . . . . . . . . . . . . . . . . 32
3.4 Medium Frequency Current Modes . . . . . . . . . . . . . . . . . . . . . . . 33
3.4.1 (IFM) Modulated Interference Current . . . . . . . . . . . . . . . . . . . . . 33
3.4.2 (AMF) Amplitude-Modulated Medium-Frequency Current . . . . . . . . . . . 34
3.4.3 (KOTS) Medium-Frequency Muscle Training. . . . . . . . . . . . . . . . . . . 36
Chapter 4 Operation of the instrument . . . . . . . . . . . . . . . . . . . . . . . 38
4.1 Mains and Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.1.1 Notes on Handling the Batteries. . . . . . . . . . . . . . . . . . . . . . . . . 38
4.1.2 EconomyMode................................. 39
4.2 Start-up of the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.3 FunctionCheck................................. 39
4.4 MonitoringNotes................................ 39
4.5 Constant Current Operation . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Chapter 5 Therapy with Stimulation Current . . . . . . . . . . . . . . . . . . . . 41
5.1 GeneralInformation............................... 41
5.2 Safety Precautions when Attaching Electrodes . . . . . . . . . . . . . . . . . 41
5.2.1 Modes of Attaching the Electrodes . . . . . . . . . . . . . . . . . . . . . . . 42
5.3 Safety Precautions for Stimulation Current Intensity . . . . . . . . . . . . . . 42
5.3.1 Recommended Intensities . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.4 Preparations and Attaching the Electrodes . . . . . . . . . . . . . . . . . . . 43
5.5 Therapy Using Low-Frequency Current Modes . . . . . . . . . . . . . . . . . 44
5.5.1 Monophase and Biphase Currents . . . . . . . . . . . . . . . . . . . . . . . 44
5.5.2 Iontophoresis .................................. 44
5.5.3 Pain Therapy, Hyperaemisation, Detonisation. . . . . . . . . . . . . . . . . . 46
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5.5.4 Muscle Stimulation Using Low-Frequency Currents . . . . . . . . . . . . . . . 47
5.6 Therapy with Medium Frequency Current Modes. . . . . . . . . . . . . . . . 50
5.6.1 Treatment with IFM Current. . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5.6.2 Pain Therapy, Hyperaemisation, Detonisation with AMF Current . . . . . . . . 51
5.6.3 Muscle Stimulation with Medium Frequency Stimulation Currents . . . . . . . 52
Chapter 6 Ultrasound Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Chapter 7 Simultaneous Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Chapter8 IndicationsMenu ..............................59
Chapter 9 Individual Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
9.1 SaveProgram.................................. 61
9.2 CallProgram................................... 62
9.3 DeleteProgram................................. 62
AppendixA Annex .....................................64
A.1 Customer Service, Maintenance, Service . . . . . . . . . . . . . . . . . . . . 64
A.2 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
A.3 Service Life and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
A.4 Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . 65
A.5 Training..................................... 65
A.6 Connecting Additional Instruments . . . . . . . . . . . . . . . . . . . . . . . 65
A.6.1 Vacuum Application Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
A.7 BasicSettings.................................. 66
A.8 TechnicalData.................................. 67
Appendix B Scope of Delivery and Accessories . . . . . . . . . . . . . . . . . . . . 69
B.1 Scope of Delivery (Mains-Operated Model) . . . . . . . . . . . . . . . . . . . 69
B.2 Scope of Delivery (Battery-Operated Model) . . . . . . . . . . . . . . . . . . 70
B.3 AvailableAccessories.............................. 70
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IONOSON-Basic iii

Appendix C Supplementary Documents . . . . . . . . . . . . . . . . . . . . . . . . 74
C.1 Manufacturer’s Recommendations . . . . . . . . . . . . . . . . . . . . . . . 74
Index......................................75
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iv IONOSON-Basic

Chapter 1 Introduction
With IONOSON-Basic you have acquired a high-quality and extremely versatile combination therapy instru-
ment. The instrument will only show its true potential, however, if you are well informed about its func-
tions. For this reason, carefully read the Operating Instructions and familiarize 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 Instrument Symbols
The meanings of the symbols placed on the instrument are as follows:
Symbol Meaning
CAUTION! Refer to the Operating Instructions and consider the physiological effects
of the parameters!
Application part Type BF, not connected to the protective conductor
Ensure environment-friendly disposal! Instruments must by any means be disposed
of separately from household garbage!
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction
IONOSON-Basic 1

1.3 Instrument Overview
Legend
1 Indicator 7 Mains Module
2 Data Selector 8 Power Switch
3 Intensity Control Channel 1 9 Patient Lead Connector
4 Intensity Control Channel 2 10 Ultrasound Lead Connector
5 Patient Current Indicator 11 Manual Release Key Socket
6 Output Indicator
1 Introduction PHYSIOMED ELEKTROMEDIZIN AG
2 IONOSON-Basic

1.4 General Notes
IONOSON-Basic may only be operated in dry rooms designed for medical purposes, in accordance with
DIN VDE 0100-710, User Class 1. These are rooms with patient beds, physical therapy rooms and practice
rooms. It complies with the technical specifications of VDE 0750/IEC 60601 and is assigned to class IIa ac-
cording to the Council Directive concerning Medical Devices.
The instrument may only be operated by qualified personnel who have undergone special training. You
must operate the instrument properly, i.e. in accordance with the Operating Instructions.
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 temperature equilibrium with its environment!
Operating the instrument in the proximity (e.g. 1 m) of a short-wave or micro-wave therapy unit may
cause output irregularities and should be avoided for this reason. Simultaneous connection of the patient
to high-frequency surgical instrument should also be avoided.
Using the electrodes near the thorax can increase the risk of ventricular fibrillation.
The equipment must be connected to the power supply via an earth wire in order to avoid electrical surge
currents.
The replacement of the lithium battery by insufficiently trained personnel can be dangerous.
CAUTION
Technical changes to the equipment are not admissible and will inevitably lead to loss of ap-
proval as a medical device!
1.5 Instrument Description
IONOSON-Basic is a two-channel combination therapy instrument.
You can apply the whole range of current modes from low to medium frequency including modulated in-
terference current. Therapy modes may be accessed directly or, by a proposed treatment, via the indica-
tions menu (refer to Indications Menu on page 59). Moreover, the instrument enables you to store up to
25 individual treatment programs or current mode sequences (refer to Individual Programs on page 61).
Besides plate electrodes and adhesive electrodes, currents can also be applied using vacuum electrodes.
For this, an external vacuum application unit can be connected (refer to Vacuum Application Unit on page 65
).
Waterproof multifrequency transducers (2.5 and 5.0 cm) made of biocompatible titanium are supplied for
ultrasound electrotherapy in the treatment frequencies 1 and 3 MHz. The instrument can also be used for
simultaneous electrotherapy (stimulation current and ultrasound in a single treatment).
The instrument can be equipped with a rechargeable battery and can then be used as a mobile unit, e.g.
in situations where no connection to the mains is available.
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction
IONOSON-Basic 3

The function of IONOSON-Basic are controlled by a microprocessor. Essential components are permanently
controlled by the processor and thus faulty operation is prevented. After switching on, all instrument func-
tions are checked during an automatic self-test routine.
The instrument complies with all current safety standards. It meets the requirements of the EC directive
concerning medical devices (93/42/EEC) and is therefore CE-labelled.
1.6 Application
The IONOSON-Basic was designed for the following applications:
Stimulation current therapy
• Pain therapy (analgesia)
• Circulatory stimulation
• Mobilization and muscle stimulation
• Iontophoresis
Ultrasound therapy
• Punctual heat therapy in the area of joints, nerves, tendons and muscles
• Pain treatment in case of arthrosis and non-articular rheumatism
• Trophism improvement in case of posttraumatic conditions and ulcus cruris
• Supporting passive and active exercises
Simultaneous Therapy
• Simultaneous application of stimulation current and ultrasound
1.7 Contraindications
Contraindications to stimulation current therapy or simultaneous treatment:
• Highly inflammatory, fever-prone disorders
• Pregnancy
• Patients with cardiac pacemakers or other implanted stimulators
• Malignant tumours
• Skin lesions
• Implants containing metal parts within the area of treatment
Contraindications to ultrasound or simultaneous therapy:
• Fever-prone disorders and acute inflammatory processes
• Tuberculosis
• Gastric ulcers
• Vascular disorders of the extremities (thrombophlebitis, thrombosis, varicosis)
• Tumours
• Circulatory insufficiency, coronary diseases, cardiac arrhythmia
• Acute articular rheumatism
• Diabetes mellitus
• Septic inflammations
1 Introduction PHYSIOMED ELEKTROMEDIZIN AG
4 IONOSON-Basic