CuraMedix OrthoPulse Pulse Wave Generator Operations Manual

O
Operating Manual
OrthoPulse
PERATIONS
MANUAL
TM
Distributed by CuraMedix
40
Albion
Road2014
Published
January,
Original
Suitelanguage:
101 German
Lincoln,
RI 02865
STORZ MEDICAL
AG
Lohstampfestr. 8
CH-8274 Tägerwilen
401-333-6500
Switzerland
www.curamedix.com
11 381 02 0114
226
»elite ed
Table of Contents
General Information
2
1.1
Introduction
1.1.1
Indications .
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1.1.2
Contraindications .
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1.1.3
Side effects .
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1.2
Symbols
8
1.3
Prerequisites for operating the OrthoPulseTM
9
1.3.1
Operator
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1.3.2
Training of the operator .
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1.4
Description of controls and functional elements
1.4.1
OrthoPulse
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10
1.4.2
Compressed air supply
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TM
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10
Installation Instructions
2.1
Unpacking
12
2.2
Scope of supply
12
2.3
Installation
13
2.3.1
Handpiece holder installation
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13
2.3.2
Connecting power supply cables
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14
2.3.3
Potential equalization .
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2.3.4
Handpiece connection
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15
Table of Contents
Operation
3.1
General warnings and safety information
16
3.2
Start-up
19
3.3
Functional checks
21
3.4
Standard settings
21
3.5
Treatment
22
3.6
Info menu
24
3.7
Resetting the handpiece pulse counter
25
Cleaning, Maintenance, Overhaul
4.1
Cleaning
26
4.2
Fuse replacement
27
4.3
Maintenance
28
4.4
Disposal
28
4.5
Repair
28
4.6
Service life
28
Status Messages and Troubleshooting
5.1
Warnings
29
5.2
Troubleshooting
31
Accessories and Spare Parts
6.1
OrthoPulseTM
32
6.2
Accessories
32
6.3
Documentation
32
7.1
OrthoPulseTM
33
7.2
Type plate
34
7.3
Conformity with directives
34
7.4
Conformity with standards
35
3
Warranty and Service
8.1
Warranty
39
8.1.1
Warranty for the control device .
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39
8.1.2
Warranty for the handpiece .
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8.2
Service
39
Table of Contents
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1
General Information
1.1
Introduction
This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations.
DANGER!
Refers to a situation of acute danger which, if
not avoided, could lead to serious or fatal injury.
WARNING!
Refers to a situation of potential danger which,
if not avoided, could lead to serious or fatal
injury.
4
CAUTION!
Refers to a situation of potential danger which,
if not avoided, could lead to minor injury.
ATTENTION
Warns against possibly harmful situations that could lead to damage to either the product or to the surrounding area.
General Information
NOTE
Additional information concerning specific features or operating instructions
is preceded by the term “NOTE”.
CAUTION!
Before you start using the OrthoPulseTM for
read in full and understood all the information
provided in this operating manual.
Familiarity with the information and instructions contained in this manual is essential for
rument, for avoiding hazards to personnel and
equipment and for obtaining good treatment
results.
Thorough knowledge of the information
included in this manual will also enable you to
react promptly and effectively in the event of
malfunctions and errors.
When using optional accessories, please also
refer to the separate operating manuals for
each of these accessories. It is imperative that
users be familiar with the content of this manual before operating any part of this system.
5
General Information
The OrthoPulseTM is a compressed air–operated ballistic pulse wave generator.
The pulse waves in the OrthoPulseTM are generated with a precision ballistic
mechanism in the handpiece. A projectile is accelerated by compressed air. The
motion and weight of the projectile produce kinetic energy. When the projectile
impacts against an immovable surface, the pulse transmitter, this kinetic energy
is converted into sound energy. This acoustic pulse is transmitted into the tissue
to be treated either directly or via an acoustic impedance adapter with the help
of a gel.
1.1.1
Indications
The OrthoPulseTM uses Extracorporeal Pulse Activation Technology
(EPAT®) to treat and relieve minor muscle aches and pains, trigger
points, tendon and/or tendon insertion pain.
1.1.2
Contraindications
CAUTION!
The contraindications listed here are examples.
No claims are made regarding the completeness or unlimited validity of this list of contraindications.
Treatment with the OrthoPulseTM is not permitted in the following cases:
6
– Coagulation disorders (hemophilia)
– Use of anticoagulants, especially Marcumar
– Thrombosis
– Tumour diseases, carcinoma patients
– Pregnancy
–
CAUTION!
Pulse waves must not be applied to target
General Information
nor to any regions near large nerves, vessels,
the spinal column or head (except in the facial
area).
1 - GENERAL INFORMATION
1.1.3
Side effects
Treatment with the OrthoPulse TM may cause the following side effects:
– Swelling, reddening, hematomas
– Petechiae
– Pain
– Skin lesions after previous cortisone therapy
These side effects generally abate after 5 to 10 days.
General Information
7
1 - GENERAL INFORMATION
1.2
Symbols
Operating manual must be observed!
Please read the operating manual!
Please comply with the operating manual!
Application unit of type B
Potential equalization
8
D-ACTOR handpiece connection
USB connection
CE mark
(in compliance with Medical Device Directive
(MDD) 93/42/EEC)
WEEE label
General Information
Wear hearing protection!
1 - GENERAL INFORMATION
1.3
Prerequisites for operating the
OrthoPulseTM
1.3.1
Operator
The OrthoPulseTM is intended exclusively for use by medical specialists and may
Such a specialist is expected to have practical knowledge of medical procedures
and applications as well as of the technology, and should be experienced in treating the indications stated in CHAPTER 1.1.1 INDICATIONS.
The specialist must have the basic physical and cognitive prerequisites such as
vision, hearing and reading. Furthermore, the basic functions of the upper
extremities must be guaranteed.
The instrument is designed for a demographic target group between 18 and 65
years.
1.3.2
Training of the operator
Operators of the OrthoPulse
TM
9
must have been adequately trained in using this
handbook. An introduction to the principles of operation will be provided by
your CuraMedix Representative with reference to this operating manual and will be
documented in the system logbook.
The operator must be instructed in the following points:
– Instruction in the operation and designated use of the instrument with
practical exercises
– Mechanism of action and function of the instrument and the energies
delivered by it
– All component settings
– Indications for use of the instrument
– Contraindications and side effects of the therapy waves
– Explanation of the warning notes in all operating statuses
Further training requirements vary from country to country. It is the operator's
responsibility to ensure that the training meets the requirements of all applicable
local laws and regulations. Further information on training in the operation of
this system is available from your CuraMedix Representative. However, you can
also contact the following address directly:
CuraMedix
40 Albion Road
Suite 101
Lincoln, RI 02865
Telephone:
Fax:
401.333.6500
401.633.6565
General Information
– Instruction in how to perform the functional checks
1 - GENERAL INFORMAT ION
1.4
Description of controls and functional
elements
1.4.1
OrthoPulseTM
4
5
6
7
8
3
2
10
9
1
General Information
Fig. 1-1 Front view of OrthoPulseTM
1
Display of selected pulse frequency
2
Treatment pulse counter
3
Display of selected pressure (nominal value)
4
Pulse counter reset button
5
Dial for setting the pressure
6
Power indicator
7
Handpiece connector
8
Handpiece
9
Buttons for setting the pulse frequency
1 - GENERAL INFORMATION
1
2
7
6
5
4
3
Fig. 1-2 Rear view of OrthoPulseTM
1
Main switch
2
Main fuse holder
3
Main connection
4
Potential equalization connection
5
Type plate
6
USB connection
11
7
NOTE
The USB connection (Fig. 1-2/6) is only suitable for connecting a USB
memory stick which supports the USB V1.1 protocol.
Compressed air supply
The compressed air is supplied by an integrated compressor.
General Information
1.4.2
2
2-I
Installation Instructions
2.1
Unpacking
NSTALLATION INSTRUCTIONS
t Carefully remove the instrument and accessories from the packaging
container.
t Check that all items are included in the packaging container and that they
are not damaged.
t Contact your supplier or the manufacturer immediately if any items are
missing or damaged.
t Retain the original packaging. It may prove useful for any later equipment
transport.
2.2
Scope of supply
The standard scope of supply of the OrthoPulseTM includes the following items:
12
– OrthoPulseTM control device
– Mains cable (EU / USA)
– Gel bottle
– User manual (operating manual, system logbook and training records)
– D-ACTOR handpiece set
– Handpiece holder, complete
Installation Instructions
Please refer to CHAPTER 6 ACCESSORIES
optional accessories.
AND
SPARE PARTS for information on
2 - I NSTALLATION I NSTRUCTIONS
2.3
Installation
2.3.1
Handpiece holder installation
desired by the system user (Fig. 2-1).
13
Fig. 2-1 Location of the bores provided on both side panels
t Remove the holders and associated screws from the packaging container.
Fig. 2-2 Position of the handpiece holder
Installation Instructions
t Mount the handpiece holder as shown in Fig. 2-2.
2.3.2
Connecting power supply cables
t Connect the supplied main cable to the main connection (Fig. 2-3/1) on
the rear of the instrument.
1
Fig. 2-3 Connecting power supply cables
14
t Insert the main plug into the socket.
Attention
When setting up the instrument, make sure that the air outlets on
the housing of the OrthoPulseTM are not blocked.
The instrument must only be connected to properly earthed and
correctly installed shockproof sockets!
2.3.3
Potential equalization
Installation Instructions
The OrthoPulseTM features a potential equalization connection
(Fig. 1-2/4).
Where necessary, connections for potential equalisation must be made by
CAUTION!
The potential equalization connection on the
OrthoPulseTM must be connected in accordance
with the relevant national regulations.
2 - I NSTALLATION I NSTRUCTIONS
2.3.4
Handpiece connection
t Connect the plug of the handpiece to the handpiece connector (Fig. 2-4) of
the OrthoPulseTM.
t Make sure that the red dots on the connector match the red dots on the
handpiece connection (Fig. 2-5).
15
Fig. 2-5 Connecting the handpiece
Installation Instructions
Fig. 2-4 Handpiece connection
t Place the handpiece into the handpiece holder.
NOTE
Please also refer to the separate operating manual for your handpiece.
3
Operation
3.1
General warnings and safety
information
3 - OPERATION
CAUTION!
The OrthoPulseTM is intended exclusively for use
by medical specialists and may only be used by
(see CHAPTER 1.3 PREREQUISITES
ORTHOPULSETM)
FOR OPERATING THE
The user is responsible for correctly positioning
the handpieces of the OrthoPulseTM.
Correct determination of the location of the treatment zone is the responsibility of the user.
16
Only perform treatments approved by CuraMedix.
To avoid safety hazards, use of the instrument for
CHAPTER 1.1.1 INDICATIONS is not allowed!
Do not use the OrthoPulseTM in potentially explosive environments, i.e. in the presence of a
oxygen or nitrous oxide.
If instruments are connected that are not medical
set up outside the vicinity of the patient.
The OrthoPulseTM has a potential equalization
connection. This must be connected in accordance
with the relevant national regulations.
Cleaning agents and disinfectants can form an
explosive atmosphere. Disconnect the
OrthoPulseTM from the mains before starting any
cleaning or maintenance work!
Operation
Do not try to open the instrument! Risk of electric
shocks!
Disconnect the handpiece from the instrument before carrying out cleaning and maintenance work.
Do not reconnect it until it has been completely
reassembled!
Risk of transmission of microorganisms! Clean the
handpiece after each use! Refer to CHAPTER 4.1
CLEANING for details.
3 - OPERATION
ATTENTION
to avoid equipment damage!
Electric medical devices are subject to special regulations regarding
electromagnetic compatibility (EMC). Hence, electric medical devices
must be installed and commissioned in accordance with the EMC
guidelines detailed in the accompanying documents.
Portable and mobile HF communications equipment (such as cell
phones) may cause interference with electric medical devices.
The use of accessories or cabling not authorized by the manufacturer may cause increased emissions or may lead to reduced interference resistance of the device.
The OrthoPulseTM must neither be deployed nor stored together
with other devices. If the operation near or jointly with other devices is required, the OrthoPulseTM must be tested in that particular
tion.
The OrthoPulseTM may be positioned and operated near the listed
accessories.
17
The instrument must only be connected to properly earthed and
correctly installed shockproof sockets!
Check that the instrument is in perfect working order before each
use (see CHAPTER 3.3 FUNCTIONAL CHECKS).
Never cover the instruments when in use!
Make absolutely sure that no liquid can seep into the system
housing or handpiece.
Any damage to the instrument resulting from incorrect operation is
not covered by the manufacturer’s warranty.
Disposal of the instrument and its components must be carried out
in accordance with national waste disposal regulations.
The OrthoPulseTM must only be used with accessories that have
been approved by the system manufacturer. To prevent safety ha-
Operation
void the CE mark approval and warranty.
3 - OPERATION
NOTE
The OrthoPulseTM meets the requirements of the applicable electromagnetic
compatibility (EMC) standards EN60601-1-2.
These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. The instrument described here
generates and uses high-frequency energy and can emit the same. If not
installed and used in accordance with these instructions, the instrument may
cause harmful interference with other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular installation. If
this product does cause harmful interference with other devices, which can
be determined by turning the instrument off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
t Reorient or relocate the receiving device.
t Increase the distance between the devices.
18
t Connect the devices to an outlet on a circuit different from that to which
the other device is connected.
Operation
t
3 - OPERATION
3.2
Start-up
NOTE
Prior to start-up, please refer to the separate operating manual for your
handpiece.
t Switch on the OrthoPulseTM at the main switch on the rear of the instrument
(Fig. 1-2/1).
Once the instrument has been started, the display automatically shows the last
t
t To change the existing setting, press one of the two arrow keys.
increased or reduced using the arrow keys.
With the OrthoPulseTM, the pulse wave frequency can be selected in steps.
operating mode
energy/frequency
D-ACTOR
4 bar/21 Hz
D-ACTOR
5 bar/12 Hz
V-ACTOR
4 bar/21 Hz
V-ACTOR
3 bar/31 Hz
19
t Set the energy of the pulses to an initial value of 1.5 bar using the dial
(Fig. 3-1/5).
Operation
The value is shown on the pressure display (Fig. 3-1/3).
3 - OPERATION
4
5
6
7
8
3
2
9
1
Fig. 3-1 Setting the energy on the control device
20
1 Display of selected pulse frequency
2 Treatment pulse counter
3 Display of selected pressure (nominal value)
4 Pulse counter reset button
5 Dial for setting the pressure
6 Power indicator
7 Handpiece connector
8 Handpiece
9 Buttons for setting the pulse frequency
The maximum application pressure is limited to 5 bar. To ensure correct system
operation, a minimum pressure of 1.0 bar is required.
t To work in single pulse mode, select the “-” symbol (dash) in the
“Frequency” selection box.
Operation
t To work in continuous pulse mode, select a continuous pulse frequency in
the range from 1 to 15 Hz in the “Frequency” selection box.
operating mode
energy/frequency
D-ACTOR
4 bar/21 Hz
D-ACTOR
5 bar/12 Hz
V-ACTOR
4 bar/21 Hz
V-ACTOR
3 bar/31 Hz
t Activate the trigger button.
NOTE
A pressure change automatically entails a change in frequency if the set
frequency exceeds the maximum permitted frequency.
3 - OPERATION
3.3
Functional checks
Perform the following functional checks after the instrument has been installed:
t Check the control device and handpiece for damage.
t Put the OrthoPulseTM into operation ( CHAPTER 3.2 START-UP).
t Set the pressure to 1.5 bar.
t Reset the treatment pulse counter (Fig. 3-1/2) with the reset button
(Fig. Fig. 3-1/4) on the front of the instrument.
t Release individual pulses in single pulse mode.
t Trigger the pulses in continuous pulse mode (pulse frequency 1 Hz and
21 Hz).
t Check that the triggered pulses are correctly counted on the treatment
pulse counter on the front of the instrument.
t Set the pressure to maximum 4 bar.
t Release individual pulses in single pulse mode.
t Trigger the pulses in continuous pulse mode (pulse frequency 1 Hz and
21 Hz).
t Test the other frequencies as follows:
operating mode
energy/frequency
D-ACTOR
4 bar/21 Hz
D-ACTOR
5 bar/12 Hz
V-ACTOR
4 bar/21 Hz
V-ACTOR
3 bar/31 Hz
3.4
21
Standard settings
t Before each treatment, set the treatment pulse counter (Fig. 3-1/2) on the
control device to zero by pressing the reset button (Fig. 3-1/4).
Treatment should always start at a low energy level. This also applies to resuming treatment after an interruption.
Operation
t Select a low energy level.
3 - OPERATION
3.5
Treatment
CAUTION !
The transport bag is provided only to transport
the device. If the device is left in the transport
bag during treatment, the device becomes hot,
due to lack of ventilation.
are possible.
t Take the device out of the transport bag during
treatment.
ATTENTION
Transport the device in the transport bag only when the condensate
collector is empty. Otherwise the water can run into the device.
22
CAUTION!
Read CHAPTER 3.1 GENERAL WARNINGS AND SAFETY
INFORMATION before beginning treatment.
Please also follow the instructions in the separate operating manual for your handpiece.
Each time after the instrument has been transported, make sure that all functional checks
have been performed on the instrument before
you start treatment.
Only perform treatments approved by
STORZ MEDICAL AG!
To avoid safety hazards, use of the instrument
CHAPTER 1.1.1 INDICATIONS is not allowed!
Operation
All status and error messages signaled during
treatment must always be attended to without
delay!
NOTE
The maximum energy level used during treatment must not cause the
patient undue pain under any circumstances.
3 - OPERATION
t
ment area and to the pulse transmitter.
t Do not apply more than 300 pulses to the same spot during treatment.
t Avoid excessive pressure of the pulse transmitter to the patient‘s skin.
Excessive pressure is not needed for the success of the treatment.
CAUTION!
The pulse transmitter surface will become hot!
Extended skin contact can lead to minor burns!
t Interrupt treatment after a maximum of
6,000 pulses.
CAUTION!
23
The handpiece may not be operated while
idling (without an impact surface).
t%POPUUSJHHFSQVMTFTVOMFTTUIFQVMTFUSBOTmitter is in contact with the treatment zone!
CAUTION!
We recommend that the user and the patient
wear suitable hearing protection.
Operation
t"MXBZTPffer the patient hearing protection.
3.6
Info menu
The Info menu enables you to reset the handpiece counter, to call up the total
pulse count and instrument operating hours as well as to read out data on moni-
t To activate the Info menu, press both arrow keys simultaneously and hold
them for two seconds.
The display changes to Info mode:
The top line (nominal energy display) shows the menu item in question as a number between 1 and 10, (Fig. 3-2/1), whereas the middle line (Fig. 3-2/2) shows
the called-up information (in this case: hardware article no.).
1
2
24
Fig. 3-2 Info mode
Use the dial to move up or down in the menu in order to call up the following
data:
Menu item
Display
1
Handpiece pulse counter
2
Total pulse counter
3
Operating hours counter
4
Hardware article no.
5
Hardware change index
6
Not used
7
Software article no.
8
Software change index
9
Boot loader article no.
10
Boot loader change index
Table 3-1 Info menu
Operation
NOTE
Pulse counter displays 1 and 2 display the pulse count in steps of one
thousand.
t To exit the Info menu, press both arrow keys simultaneously and hold them
for two seconds.
3 - OPERATION
3.7
Resetting the handpiece pulse counter
t Switch to Info mode (see CHAPTER 3.6 INFO
MENU).
t Select menu item 1 – Handpiece counter.
The number of pulses is displayed in steps of one thousand. The value displayed
in the middle line multiplied by 1,000 gives the counter reading for the current
handpiece.
t Press the reset button to set the handpiece counter to zero.
NOTE
Pressing it for longer, causes it to function as a tip switch, i.e. pulses will be
triggered until the button is released.
Operation
25
4
Cleaning, Maintenance,
Overhaul
4 -C
,M
,O
4.1
Cleaning
LEANING
AINTENANCE
VERHAUL
Regular cleaning of the system ensures perfect hygiene and operation of the
OrthoPulseTM.
CAUTION!
Disconnect the instrument from the mains
before starting any cleaning or overhaul work!
t Wipe the exterior of the housing with a damp cloth. Use soapy water or a
mild cleaning agent.
26
Attention
It is essential that no fluid be permitted to penetrate either the
instrument or its tubing.
Cleaning, Maintenance, Overhaul
NOTE
For additional information on cleaning and overhauling your handpiece,
please refer to the separate operating manual for your handpiece.
4.2
Fuse replacement
The main fuse holder is located on the rear panel of the OrthoPulse
.
TM
t Push the clip of the main fuse holder ( Fig. 4-1/1) upwards and take the
holder off the housing.
1
27
Fig. 4-1 Main fuse holder
t Pull the old fuses out of the main fuse holder ( Fig. 4-2/1).
1
t Replace the fuses (T2AL/250 VAC).
t Push the main fuse holder back into the opening until it engages.
Cleaning, Maintenance, Overhaul
Fig. 4-2 Fuse replacement
4 -CLEANING, MAINTENANCE, OVERHAUL
4.3
Maintenance
Preventive maintenance is not necessarily required. However, regular maintenance may help to identify possible defects at an early stage and thus increase
the safety and service life of the equipment.
Maintenance services can be ordered from our regional representatives in your
area or directly from CuraMedix.
We recommend that functional and safety checks be performed at least once a
year. National accident prevention regulations and test and inspection intervals
prescribed for medical devices must, of course, be observed.
NOTE
For further details on content and performance of the safety checks please
contact your local dealer.
The following checks should be performed to ensure that the OrthoPulseTM
operates safely.
28
1
Earth leakage current test in accordance with national regulations.
2
Earth impedance test (incl. applicator housing and with main cable) in
accordance with national regulations.
4.4
Disposal
When disposing of the present medical products, no special measures have to be
tions. After expiration of its service life, dispose of the OrthoPulseTM as waste
electronic equipment.
Cleaning, Maintenance, Overhaul
4.5
Repair
Repair work on defective instruments must only be carried out by personnel
suitably authorized by CuraMedix. Only original CuraMedix spare parts may be
used for this purpose. The personnel suitably authorized can be from CuraMedix
or representatives of CuraMedix agencies and dealers.
4.6
Service life
The average expected service life is approximately.
– 10 years for the OrthoPulseTM.
For information about the service life of your handpiece, please refer to the
separate operating manual for your handpiece.
Exceeding the service life can be expected to result in a failure of the instrument
and accessories. This also applies to handpieces.
No warranty claims shall be accepted beyond the information given in CHAPTER 8
WARRANTY AND SERVICE.
5
5-S
M
T
Status Messages
and Troubleshooting
5.1
Warnings
TATUS
ESSAGES AND
ROUBLE SHOOTING
The following list gives the most important error codes and the actions that you
should take if they occur.
Error number
Fault description
Corrective action
Memory error
Acknowledge by pressing
,
the reset button
continued operation is
possible.
Error 1
Error 10
Release the trigger button,
Trigger button is
continued operation is
pressed during start-up
possible.
29
The handpiece is not
connected
Connect the handpiece,
continued operation is
possible.
Internal fault
Acknowledge by pressing
the reset button
,
continued operation is
possible.
Internal fault
Acknowledge by pressing
,
the reset button
continued operation is
possible.
Internal fault
Acknowledge by pressing
the reset button
,
continued operation is
possible.
Error 12
Error 20
Error 21
Status Messages and Troubleshooting
Error 11
5 - STATUS MESSAGES AND TROUBLE-SHOOTING
Error 22
Problem with update
on USB stick
Acknowledge by pressing
.
the reset button
Check update on stick,
continued operation is
possible.
USB stick not inserted
Insert USB stick.
Problem with update
on USB stick
Acknowledge by pressing
.
the reset button
Check update on stick,
continued operation is
possible.
Problem with update
on USB stick
Acknowledge by pressing
.
the reset button
Check update on stick,
continued operation is
possible.
No current software
update
Acknowledge by pressing
.
the reset button
Check update on stick,
continued operation is
possible.
Error 23
30
Error 24
Status Messages and Troubleshooting
Error 25
Error 26
Table 5-1 Warnings
5.2
Troubleshooting
CAUTION !
Unplug the main cable from the instrument
before you carry out any maintenance work!
Fault description
Possible cause
Corrective action
Instrument does not
work
Power failure
Check the power supply.
Defective main fuse
Replace the fuses.
Defective main plug
Replace the main cable.
Leaks in handpiece
cable or cable not
properly connected
Check the cable and tube
connections and replace
them, if necessary.
No compressed air
supply
31
Clogged compressor air Check the compressor air
filter and replace it, if
necessary.
Blocked or worn
projectile
Call your Service center.
Dismantle the handpiece.
Clean the guide tube and
projectile.
Overhaul the handpiece.
Malfunction in control
device
Call your Service center.
Handpiece defective
Replace the handpiece.
Table 5-2 Troubleshooting
Status Messages and Troubleshooting
No pulse wave power No compressed air
output
supply
6
-A
S
P
Accessories and 6Spare
Parts
6.1
OrthoPulseTM
CCESSORIES AND
PARE
Mains cables
Main cable CEE 7 Europe, 4 m long
13455
Main cable CH 3 m long
13448
Main cable USA 3 m long
16441
NOTE
For information on the D-ACTOR handpiece and its accessories please refer
to the separate operating manual for the D-ACTOR handpiece.
Accessories and Spare Parts
32
6.2
Accessories
Gel bottle 500 ml
18189
OrthoPulseTM equipment trolley
20494
OrthoPulseTM transport case
17415
Acoustic impedance adapter (50 pcs)
13470
F-Meter set
15323
V-ACTOR II handpiece set
20212
V-ACTOR II handpiece holder
18825
6.3
Documentation
OrthoPulseTM user manual
22629
ARTS
7
7-T
S
Technical Specifications
7.1
OrthoPulseTM
ECHNICAL
PECIFICATIONS
D-ACTOR operating mode
single pulse,
continuous pulse 1-21 Hz/4 bar
in steps of 0.1 bar
continuous pulse 1-12 Hz/5 bar
in steps of 0.1 bar
V-ACTOR operating mode
1 - 31 Hz/3 bar
1 - 21 Hz/4 bar
Main input voltage
100 – 240 VAC
Main frequency
Main fuse
50 / 60 Hz
T2AL/250 VAC
Power consumption
Compressed air output
max. 200 VA
1 – 5 bar
Ambient temperature during
operation
10 – 40 °C
Ambient temperature during
storage and transport
0 - 60 °C frost free
Ambient pressure
during operation
800 – 1060 hPa
Ambient pressure
during storage and transport
500 - 1060 hPa
Air humidity
33
5 – 95%, non-condensing
Control device weight
Housing dimensions (W x H x D)
9.9 kg
340 x 165 x 340 mm
Class IIa device
Protection against the ingress of
water
Table 7-1
IPX1
OrthoPulseTM
Equipment safety (“essential performance“) according to IEC 60601-1, 3rd
edition:
tolerance of 10%.
NOTE
When the medical product is distributed to third parties, the following must
be observed:
– The complete device documentation must be delivered together with the
medical product.
– The medical product may only be exported to a foreign country when the
medical product and the corresponding indications are allowed there.
Technical Specifications
*These values apply to instruments in the “elite edition+”. These are instruments from serial number
OS.3136 onwards.
7 - Technical SpecificaTionS
7.2
Type plate
Fig. 7-1 Type plate
34
Fig. 7-2 Location of the type plate
Technical Specifications
7.3
Conformity with directives
This medical product bears the CE mark in accordance with the Medical Device
Directive (MDD) 93/42/EEC.
7 - TECHNICAL SPECIFICATIONS
7.4
Conformity with standards
This device complies with the applicable standards EN 60601-1, CAN CSA-C22.2
No.601.1, UL Std. No 60601-1.
According to EN 60601-1
- Type of protection against electric pulses:
Protection class 1
- Application unit of Type B
EMC guidelines and manufacturer's declaration
Guidelines and manufacturer's declaration –
emitted electromagnetic interference
The OrthoPulseTM model is intended for use in the electromagnetic environment
specified below. The customer or the user of the OrthoPulseTM should assure
that it is used in such an environment.
HF emissions
according to CISPR 11
Group 1
HF emissions according to CISPR 11
Class B
Harmonic emissions according to
IEC 61000-3-2
Class A
cording to IEC 610003-3
Complies
Electromagnetic environment –
guidelines
The OrthoPulseTM uses HF energy only
for its internal functioning. Therefore, its
HF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
The OrthoPulseTM is suitable for use in
all facilities, including those in residential areas and those that are directly
connected to a public electricity supply
network that also powers devices which
are used for residential purposes.
Technical Specifications
Emitted interferCompliance
ence measurements
35
7 - TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration –
Resistance to emitted electromagnetic interference
The OrthoPulseTM
The customer or the user of the OrthoPulseTM should assure that it is used in such an environment.
Emissions
resistance tests
IEC 60601
test level
Compliance
level
Electromagnetic environment –
guidelines
Electrostatic discharge (ESD) according to IEC 610004-2
±6 kV contact
discharge
±8 kV air discharge
±6 kV contact
discharge
±8 kV air discharge
Electrical fast transient disturbances /
bursts according to
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Main power quality should be that
of a typical commercial or hospital
environment.
Surges according to
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Main power quality should be that
of a typical commercial or hospital
environment.
Voltage drops, short
interruptions and
voltage variations on
power supply input
lines according to
IEC 61000-4-11
< 5% UT
< 5% UT
(> 95% drop in
UT) for ½ period
(> 95% drop in
UT) for ½ period
40% UT
40% UT
(60% drop in UT)
for 5 periods
(60% drop in UT)
for 5 periods
70% UT
70% UT
Main power quality should be that of
a typical commercial or hospital
environment. If the user of the
OrthoPulseTM requires continued
operation during power main
interruption, it is recommended that
the OrthoPulseTM be powered from an
uninterruptible power supply or
a battery.
(30% drop in UT)
for 25 periods
(30% drop in UT)
for 25 periods
< 5% UT
< 5% UT
(> 95% drop in
UT) for 5 s
(> 95% drop in
UT) for 5 s
3 A/m
3 A/m
36
Power frequency
(50/60 Hz) magnetic
Floors should be wood, concrete or
synthetic material, the relative humidity should be at least 30%.
should be those of a typical business
or hospital environment.
Technical Specifications
IEC 61000-4-8
NOTE
UT is the main alternating voltage prior to application of the test level.
7 - TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration –
Resistance to emitted electromagnetic interference
The OrthoPulseTM
The customer or the user of the OrthoPulseTM should assure that it is used in such an environment.
Emissions
resistance tests
IEC 60601
test level
Compliance
level
Electromagnetic environment – guidelines
Portable and mobile RF equipment should be
used no closer to any part of the OrthoPulseTM,
including cables, than the recommended safety
distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended safety distance:
Conducted HF
interference
according to
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Radiated HF
interference
according to
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
d = 1.2√P
d = 1.2√P
for 80 MHz to 800 MHz
37
d = 2.3√P
for 800 MHz to 2.5 GHz
Where P is the rated power of the transmitter in
watts (W) according to the transmitter manufacturer and d is the recommended safety distance
in metres (m).
based on an on-site inspection a, should be less
than the compliance level.b
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected
a
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment with respect to
intensity at the location in which the OrthoPulseTM is used exceeds the applicable HF compliance
level indicated above, the OrthoPulseTM should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the OrthoPulseTM.
b
Technical Specifications
Interference may occur in the vicinity of instruments marked with the following symbol.
7 - TECHNICAL SPECIFICATIONS
Recommended safety distances between portable and
mobile HF communications equipment and the OrthoPulseTM
The OrthoPulseTM is intended for use in an electromagnetic environment in which radiated HF
disturbances are controlled. The operator or the user of the OrthoPulseTM can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile HF
communications equipment (transmitters) and the OrthoPulseTM as recommended below, according to the maximum output power of the communications equipment.
Safety distance according to frequency of transmitter [m]
Rated power
of transmitter
[W]
38
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended safety distance can be estimated using the equation applicable to the frequency of the transmitter, where P is
the rated power of the transmitter in watts [W] according to the transmitter manufacturer.
Technical Specifications
NOTE 1
An additional factor of 10/3 was used for calculating the recommended safety distance of transmitters in the frequency range from 80 MHz to 2.5 GHz in order to reduce the probability that a
mobile/portable communications device brought into the patient area inadvertently might lead to
a malfunction.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
8
Warranty and Service
8-W
8.1
Warranty
ARRANTYAND SERVICE
ATTENTION
z
z
personnel will relieve the manufacturer of its liability and responsibility for safe system operation. This will automatically void the
warranty even before the end of the warranty period.
8.1.1
Warranty for the control device
During the two-year warranty period from the date of delivery of the product to
the end customer, defects will be remedied at no charge to the customer upon
the customer furnishing adequate proof that the defect is due to defects in
material or workmanship. The warranty does not extend to wear parts.
39
Transport costs and the risk of loss during the shipping of returned products
shall be borne by the customer.
Please complete the attached warranty card and return it as soon as possible to
the address below:
CuraMedix
40 Albion Road
Suite 101
Lincoln, RI 02865
8.1.2
Warranty for the handpiece
The warranty conditions for the handpiece can be found in the operating
manual for the corresponding handpiece.
Missing components will be replaced subject to charge. Accessories also sent will
be checked and, if necessary, replaced after we have assessed them.
Pulse transmitters and overhaul kits are not covered by the handpiece’s warranty.
8.2
Service
Should you have any further questions or require additional information, please
feel free to contact CuraMedix.
Warranty and Service
Warranty claims will only be accepted if the handpiece is returned in its complete