GymnaUniphy Combi 200 User manual

COMBI 200
User Manual
Pasweg 6A
B-3740 Bilzen
Tel.: (+32) (0) 89/510.510
Fax: (+32) (0) 89/510.511
www.gymna-uniphy.com
E-mail: [e-mail]
Your dealer:
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Combi 200
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User Manual Combi 200
Device for electrotherapy, ultrasound therapy and combination
therapy
Manufacturer GymnaUniphy N.V.
Main office Pasweg 6A
B-3740 BILZEN
Telephone +(32) (0)89-510.510
Fax +(32) (0)89-510.511
E-mail [e-mail]
Website www.gymna-uniphy.com
Version 1.1
March 2005
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Abbreviations
Symbols on the equipment
Symbols in the manual
AQ Accomodation Quotient
CC Constant Current
CO Combination therapy
CP Courte Période
CV Constant Voltage
DF Diphasé Fixe
EL Electrode
EMC Electromagnetic Compatibility
ESD Electrostatic Discharge
ET Electrotherapy
HAC Hospital Antiseptic Concentrate
LP Longue Période
MF Medium Frequency: with unidirectional and interferential currents
Monophasé Fixe: with diadynamic currents
MTP Myofascial Trigger Point
NMES Neuro Muscular Electro Stimulation
TENS Transcutaneous Electrical Nerve Stimulation
US Ultrasound
VAS Visual Analogue Scale
Read the manual
Manufacturer
Warning or important information.
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TABLE OF CONTENTS
1 SAFETY ............................................................................................ 7
1.1 PURPOSE .................................................................... 7
1.2 SAFETY INSTRUCTIONS ................................................... 7
1.3 MEDICAL DEVICES DIRECTIVE ........................................... 9
1.4 LIABILITY .................................................................. 10
2 INSTALLATION .............................................................................. 11
2.1 RECEIPT .................................................................... 11
2.2 PLACING AND CONNECTION ........................................... 11
2.3 PERFORMING THE FUNCTIONAL TEST ................................. 11
2.4 SETTING CONTRAST AND SELECTING LANGUAGE .................. 11
2.5 TRANSPORT AND STORAGE ............................................ 12
2.6 RESELLING ................................................................. 12
3 DESCRIPTION OF THE EQUIPMENT ............................................ 13
3.1 COMBI 200 AND STANDARD ACCESSORIES ........................ 13
3.2 COMPONENTS OF COMBI 200 ........................................ 14
3.3 DISPLAY ................................................................... 15
3.4 DISPLAY SYMBOLS ....................................................... 16
3.5 SYMBOLS FOR CURRENT SHAPES IN MEMORY MENU .............. 16
3.6 PARAMETER SYMBOLS .................................................. 17
3.7 CURRENT SHAPES ........................................................ 18
4 OPERATION ................................................................................... 19
4.1 THERAPY SELECTION .................................................... 19
4.2 PERFORMING THERAPY .................................................. 22
4.3 ELECTROTHERAPY ........................................................ 24
4.4 ULTRASOUND THERAPY ................................................. 32
4.5 COMBINATION THERAPY ................................................ 34
4.6 DIAGNOSTIC PROGRAMS ................................................ 34
4.7 PROGRAMS ................................................................ 36
4.8 SYSTEM SETTINGS ....................................................... 39
5 INSPECTIONS AND MAINTENANCE ........................................... 43
5.1 INSPECTIONS .............................................................. 43
5.2 MAINTENANCE ............................................................ 45
6 MALFUNCTIONS, SERVICE AND GUARANTEE ......................... 47
6.1 MALFUNCTIONS .......................................................... 47
6.2 SERVICE ................................................................... 48
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6.3 GUARANTEE ............................................................... 48
6.4 TECHNICAL LIFE TIME ................................................... 49
7 TECHNICAL INFORMATION ......................................................... 51
7.1 GENERAL .................................................................. 51
7.2 ELECTROTHERAPY ........................................................ 51
7.3 ULTRASOUND THERAPY ................................................. 54
7.4 ENVIRONMENTAL CONDITIONS ......................................... 55
7.5 TRANSPORT AND STORAGE ............................................ 55
7.6 STANDARD ACCESSORIES .............................................. 56
7.7 OPTIONAL ACCESSORIES ELECTROTHERAPY ......................... 57
7.8 OPTIONAL ACCESSORIES ULTRASOUND THERAPY .................. 58
8 APPENDICES ................................................................................. 59
8.1 AGENTS FOR IONTOPHORESIS ......................................... 59
8.2 DIAGNOSTIC I/T-CURVE ................................................ 60
8.3 EMC DIRECTIVE .......................................................... 61
8.4 TECHNICAL SAFETY INSPECTION ...................................... 65
8.5 DISPOSAL ................................................................. 69
9 REFERENCE ................................................................................... 71
9.1 FUNCTION OVERVIEW .................................................... 71
9.2 LITERATURE ............................................................... 76
9.3 TERMINOLOGY ............................................................. 76
10 INDEX ............................................................................................. 81

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1SAFETY
1.1 Purpose
The Combi 200 is intended solely for medical applications. You can use the
Combi 200 for electrotherapy, ultrasound therapy and combination therapy.
The device is suited for continuous use.
1.2 Safety instructions
1.2.1 General
•Only qualified people who are trained in the application of the
therapies may use the appliance.
•Only a technician authorised by GymnaUniphy N.V. may open
the equipment or the accessories.
•Follow the instructions and directions in these user
instructions.
•Place the equipment on a horizontal and stable base.
•Keep the ventilation openings at the bottom and rear of the
equipment free.
•Do not place any objects on the equipment.
•Do not place the equipment in the sun or above a heat source.
•Do not use the equipment in a damp area.
•Do not let any liquid flow into the equipment.
•Do not disinfect or sterilise the equipment. Clean the
equipment with a dry or moistened cloth. See §5.
•Only treat patients with electrical implants (pacemaker) after
obtaining medical advice.
•The 'Directive on Medical Devices' from the European
Commission (93/42/EEG) requires that safe devices are used.
It is recommended to perform a yearly technical safety
inspection. See §5.1.2.
•For optimum treatment, a patient investigation must first be
performed. On the basis of the findings of the investigation, a
treatment plan with objectives will be formulated. Follow the
treatment plan during the therapy. This will limit possible risks,
related to the treatment, to a minimum.
•Always keep these user instructions with the equipment.
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1.2.2 Electrical safety
1.2.3 Prevention of explosion
1.2.4 Electromagnetic Compatibility
•Only use the equipment in an area with facilities that meet the
applicable legal regulations.
•Connect the equipment to an outlet with a protective earth
terminal. The outlet must meet the locally applicable
requirements for medical areas.
•Do not use the equipment in an area where combustible
gases or vapours are present.
•Switch off the equipment when it is not used.
•Medical electrical equipment requires special precautions for
Electro Magnetic Compatibility (EMC). Follow the instructions
for the installation of the equipment. See §2
•Do not use mobile telephones or other radio, shortwave, or
microwave equipment in the vicinity of the equipment. This
kind of equipment can cause disturbances.
•Only use the accompanying accessories that are supplied by
GymnaUniphy. See §7.6, §7.7 and §7.8.
Other accessories can lead to an increased emission or a
reduced immunity.
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1.2.5 Electrotherapy
1.2.6 Ultrasound therapy
1.3 Medical Devices Directive
The device complies with the essential requirements of the Medical Device
Directive of the European Committee (93/42/EEC) as most recently
changed.
•Do not use the equipment simultaneously with high frequency
surgical equipment. This combination can cause burning of
the skin under the electrodes.
•Do not use adhesive electrodes with currents that have a
galvanic component, such as galvanic, diadynamic, MF
rectangular, pulsed rectangular and triangular currents. With
these currents, etching of the skin can occur.
•Check the electrode cables and the electrodes at least once a
month. Check whether the insulation is still intact. See §5.1.
•The safety standards for electrical stimulation advise not to
exceed the current density of 2.0 mArms/cm2.
However, with iontophoresis treatments, we advise a
maximum current density of 0.25 mÂ/cm2, because of using
the MF rectangular current. Exceeding this value can result in
skin irritation and burns.
•Always use sterilised gauze with iontophoresis treatments.
•Move the US head evenly over the skin during the treatment.
This prevents internal burns.
•The US treatment heads are exchangeable. The device
detects the characteristics and supplies the right power at the
right frequency.
•Handle the US heads carefully. With rough handling, the
characteristics can change. Test the US head if it falls on the
ground or knocks against something. See §5.1.1.
•Check the US head at least once a month. During the check,
look for dents, cracks and other damage that could allow
liquids to ingress. Check whether the insulation of the cable is
still intact. Check whether all pins are present and straight in
the connectors. Replace the US head if the head, the cable or
the connector is damaged. See §5.1.
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1.4 Liability
The manufacturer cannot be held liable for injury to the therapist, the
patient or third parties, or for damage to or by the equipment used, if for
example:
•an incorrect diagnosis is made;
•the equipment or the accessories are used incorrectly;
•the user instructions are wrongly interpreted or ignored;
•the equipment is badly maintained;
•maintenance or repairs are performed by people or organisations that
are not authorised to do so by GymnaUniphy.
Neither the manufacturer nor the local GymnaUniphy dealer can be held
liable, in any way whatsoever, for the transfer of infections via the vaginal,
anal and rectal probes and/or other accessories.
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2INSTALLATION
2.1 Receipt
1. Check whether the equipment has been damaged during transport.
2. Check whether the accessories are intact and complete. See §7.6, §7.7
and §7.8.
•Inform your supplier of any damage or defects by no later than
within 3 working days after receipt. Report the damage by
telephone, fax, e-mail or letter.
•Do not use the equipment if it is damaged or defective.
2.2 Placing and connection
1. Place the equipment on a horizontal and stable base.
•Keep the ventilation openings at the bottom and rear of the
equipment free.
•Do not place the equipment in the sun or above a heat source.
•Do not use the equipment in a wet area.
2. Check whether the mains voltage that is stated on the rear of the
equipment corresponds with the voltage of your mains supply. The
equipment is suited for a nominal mains voltage from 100 V to 240 VAC
/ 50-60 Hz.
3. Connect the device to an outlet with protective earth terminal.
2.3 Performing the functional test
1. Switch the equipment on with the switch at the rear of the equipment.
2. When the equipment is switched on, it automatically performs a test.
Check whether the indicator lamps next to and light briefly
during the test.
3. If the lamps do not light up: See §6.
2.4 Setting contrast and selecting language
1. Press for 5 seconds. The System setting menu appears. See §4.8.
2. Press next to Contrast, 1st key from the top.
3. If necessary, change the contrast with and .
4. Press next to Language.
5. If necessary, change the language with and .
6. Press to return to the start menu.
A B
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2.5 Transport and storage
Take account of the following matters if the equipment has to be
transported or stored:
•Transport or store the equipment in the original packaging.
•The maximum period for transport or storage is: 15 weeks.
•Temperature: -20 °C to +60 °C.
•Relative humidity: 10% to 100%.
•Atmospheric pressure: 200 hPa to 1060 hPa.
2.6 Reselling
This medical equipment must be traceable. The equipment, the US head
and some other accessories have a unique serial number. Provide the
dealer with the name and address of the new owner.
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Combi 200
3DESCRIPTION OF THE EQUIPMENT
3.1 Combi 200 and standard accessories
1. Combi 200. See §3.2.
2. Power cord
3. Contact gel
4. US head
5. VAS score card
6. Elastic fixation straps (4 pieces)
7. EL sponges for rubber
electrode (4 pieces)
8. Rubber electrodes (4 pieces)
9. Two-ply electrode cable (2
pieces)
10. Test connector
9
8 3
2
7 6
10 1
5 4
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3.2 Components of Combi 200
1. Display. See §3.3.
2. Electrotherapy
3. Ultrasound therapy
4. Combination therapy
5. Memory
6. Start menu
7. Channel selection: A or B
8. Stop
9. Intensity of channel A
10. Pause
11. Return to previous menu
12. Intensity of channel B
13. Enter
14. Indication: Read manual
15. Down
16. Up
17. Select parameter or menu
18. Connector for US head
19. On/off switch
20. Fuse holder
21. Connection to mains supply
22. Type plate
23. Ventilation opening
24. Connector for electrotherapy,
channel A
25. Indicator lamp for channel A
26. Indication: Floating patient
circuit
27. Connector for electrotherapy,
channel B
28. Indicator lamp for channel B
A
AB
B
!
AB
2
3
4
5
6
7
8139101112
1
16
17
15
14
24
26
27
18
19 21 22 23
20
25 28
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3.3 Display
1. Channel
2. Therapy
3. Current shape
4. Title of the screen
5. Program number
6. Parameters with selection
knobs
7. Use to go to the next
parameters
8. Explanation or recommendation
9. Screen for channel A (here,
electrotherapy). See §4.3.5.
10. Remaining treatment time
11. Polarity
12. Set intensity
13. Screen for channel B (here,
ultrasound therapy). See §4.4.2.
Pulse time 40 s
US+Conv.TENS 34
Pulse form
Min. frequency
frequency
Max.
80
100
Hz
Hz
Sweep mode
Treatment time 15:00
15:00
red+
0CV
set00
00
.
.
Perceptibe, comfortable
123 4 5
6
7
8
9
10
12
11
13
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3.4 Display symbols
3.4.1 General
3.4.2 Current shape groups
3.5 Symbols for current shapes in memory menu
Electrotherapy Channel A
Ultrasound therapy Channel B
Combination therapy Channel A and B
simultaneously
Sequential current
shapes Treatment time
Treatment completed
Unidirectional currents 2-pole medium frequency
Diadynamic 4-pole Interferential
TENS currents 4-pole interferential with
vector
NMES currents Diagnostic programs
Medium frequency
unidirectional current Burst TENS
Unidirectional rectangular
current
Rectangular surge
current
Unidirectional triangular
current Triangular surge current
Conventional TENS Biphasic surge current
Low frequency TENS Intrapulse interval surge
current
Random TENS 2-pole medium frequency
surge current
A
B
A + B
SEQ
0:00
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3.6 Parameter symbols
3.6.1 Electrotherapy
Sweep mode
3.6.2 Ultrasound therapy
CP (diadynamic) 2-pole medium frequency
DF (diadynamic) 4-pole interferential with
rotating vector
LP (diadynamic) Rheobase and chronaxie
MF (diadynamic) Rheobase and AQ
Polarity indication Constant Current
Alternating polarity Constant Voltage
Biphasic pulse shape,
symmetrical mA peak
Biphasic pulse shape,
asymmetrical Volt peak
12s/12s 1s/5s -1s/5s
6s/6s 1s/1s
US duty cycle 10% US duty cycle 100%
US duty cycle 20% Set US intensity
US duty cycle 30% Peak US output power
US duty cycle 40% Unit of the set US
intensity
US duty cycle 50%
CP
DF
LP CHR
MF AQ
Red+
Red- CC
+-CV
mA
V
12
12 55
11
6
6
1
1
1
10ms 10% 100%
2
10ms 20%
set
3
10ms 30%
pk
P
4
10ms 40%
W cm2
/
5
10ms 50%
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3.7 Current shapes
3.7.1 Unidirectional currents
3.7.2 Diadynamic currents
3.7.3 Interferential currents
3.7.4 TENS currents
3.7.5 NMES currents
Rectangular pulse current Triangular pulse current
2-5 current (UltraReiz) Medium frequency
rectangular current
MF CP
DF LP
2-pole medium frequency 4-pole interferential with
rotating vector
4-pole Interferential
Conventional TENS,
asymmetrical
Conventional TENS,
alternating symmetrical
Conventional TENS,
alternating asymmetrical TENS burst
Conventional TENS,
symmetrical TENS burst, alternating
Rectangular surge
current Biphasic surge current
Triangular surge current Intrapulse interval surge
current
Medium frequency surge
current (2- and 4-pole)
2 ms 5 ms
MF DF
MF DF
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4OPERATION
4.1 Therapy selection
You can select a therapy in different ways, with the therapy keys or with the
parameters in the Start menu:
•Therapy keys: Quickly select a therapy with therapy keys , and .
See §4.1.1.
•Objectives: Select a therapy on the basis of an objective. See §4.1.2.
•Indication list: Select a therapy on the basis of a medical indication.
See §4.1.3.
•Program number: Select a certain program number or a program
number that you previously saved. See §4.1.4.
•Diagnostic programs: Perform a diagnosis, for example to determine
the rheobase and the chronaxie. See §4.1.5.
•Contra indications: Display an overview with contra indications for the
different therapies. See §4.1.6.
Besides this, you can change the system settings. See §4.8.
4.1.1 Therapy keys
Electrotherapy, direct selection
1. Press : Electrotherapy.
2. Select the current shape group
with .
3. Select the current shape with
.
Ultrasound therapy, direct selection
1. Press : Ultrasound therapy. The Ultrasound screen appears.
Combination therapy, direct selection
1. Press : Combination therapy.
2. Select the current shape with . See §4.5.1.
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4.1.2 Therapy selection via objectives
1. Press to go to the start menu.
2. Select Objectives.
3. Select Electrotherapy or
Ultrasound therapy.
4. Select the desired treatment
with .
4.1.3 Therapy selection via indication list
1. Press to go to the start menu.
2. Select Indication list.
3. Go to the following indications
with or . See §9.1.4.
4. Select the desired indication
with .
•ET: Electrotherapy
•US: Ultrasound therapy
•CO: Combination therapy
4.1.4 Program number selection
1. Press to go to the start menu.
2. Select Program number.
3. Select the desired program with
or . See §9.1.
4. Press . See §4.7.
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4.1.5 Diagnostic program selection
With the diagnostic programs, you can localise and treat pain points, and
look for stress fractures, etc.
1. Press to go to the start menu.
2. Select Diagnostic programs.
3. Select the desired diagnosis
with . See §4.6.
4.1.6 Contra indication selection
1. Press to go to the start menu.
2. Select Contra indications.
3. Select the therapy for which you
want to see the contra
indications.
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