Modula Paris
Modula Paris
Modula Paris
0482
G. Heinemann Medizintechnik GmbH
MODULA Paris
Introduction
Thank you for choosing to purchase the MODULA Paris treatment unit. Its modular design allows the unit to
be used for a wide range of applications in every practice or hospital.
These operating instructions contain information on operation, care and simple maintenance tasks. All of the
information on the following pages relates to a MODULA unit fitted with all optional items of equipment.
Descriptions for items which are not installed are therefore non-binding. If you would like to add specific
optional equipment to your MODULA unit, please contact us on: +49 4191-95379-0
Caution! Before using the treatment unit, please read these operating instructions
carefully.
These operating instructions were produced by G. Heinemann Medizintechnik GmbH and have been
checked for accuracy. They do not, however, claim to be exhaustive. All information may be amended
without prior notification.
No part of these operating instructions may be copied or broadcast by any method or means, whether
electronic or mechanical, without the express written approval of G. Heinemann Medizintechnik GmbH.
Manufacturer:
G. Heinemann Medizintechnik GmbH, Leibnizstraße 13-15, D-24568 Kaltenkirchen
Phone: +49 4191-95379-0, Fax: +49 4191-9537937, E-mail: info@heinemann-ent.de
Web: www.heinemann-ent.de
Contents
Introduction ......................................................................................................................................................... 3
Signs and symbols .............................................................................................................................................. 3
1 General notes for usage ............................................................................................................................. 5
1.1 Purpose of the device ........................................................................................................................ 5
1.2 Indications / Contraindications ........................................................................................................... 6
2 Delivery and unpacking .............................................................................................................................. 7
2.1 Returns .............................................................................................................................................. 7
2.2 Connecting and setting up the unit .................................................................................................... 7
3 Safety instructions ...................................................................................................................................... 8
4 Note on operation ....................................................................................................................................... 9
4.1 Main power switch ............................................................................................................................. 9
4.2 Mirror heater .................................................................................................................................... 10
4.3 Suction with manual emptying (option) ............................................................................................ 10
4.4 Suction with „Sekretomatik“ system (option) ................................................................................... 11
4.5 Cold light sources (option) ............................................................................................................... 12
4.6 Compressed air unit (option) ........................................................................................................... 13
4.7 Ear irrigation with water connection (option) ................................................................................... 13
4.8 Ear irrigation with autonomous water system (option) .................................................................... 14
4.9 Tube rinsing system (option) ........................................................................................................... 15
4.10 Tube rinsing system with disinfectant (option)................................................................................. 15
4.11 Laryngoscope/ endoscope holders (option) .................................................................................... 16
4.12 Heated instrument tray (option) ....................................................................................................... 16
5 Maintenance and repair ............................................................................................................................17
5.1 Cleaning ........................................................................................................................................... 17
5.2 Changing the bacteria filter .............................................................................................................. 18
5.3 Emptying the suction reservoir ........................................................................................................ 18
5.4 Replacing the waste bag ................................................................................................................. 19
5.5 Optical cable .................................................................................................................................... 19
5.6 Replacing the halogen lamp ............................................................................................................ 19
5.7 Cleaning the water filter ................................................................................................................... 20
5.8 Replacing fuses ............................................................................................................................... 22
6 Hygiene .....................................................................................................................................................23
7 Guarantee .................................................................................................................................................24
8 Annex ........................................................................................................................................................25
8.1 Technical details .............................................................................................................................. 25
8.2 Figures ............................................................................................................................................. 25
8.3 Consumables & spare parts ............................................................................................................ 27
The MODULA treatment unit may only be used by persons offering a guarantee of correct usage of the
device and who have been instructed in its use. Instruction may only be given by authorized G. Heinemann
Medizintechnik GmbH personnel.
As for all highly developed technical devices, care and regular maintenance of the treatment unit is very
important. You should also ensure that you are thoroughly familiar with the functions and specifications of
the device.
Caution! Before using the device in actual practice, it is essential that you thoroughly
familiarise yourself with the functions of the treatment unit.
Should you require further information, please contact our sales and service office. Telephone: +49 4191-
95379-0
The product is a Class IIa medical device as defined by Directive 93/42/EEC. The product is to be used for
human medical purposes only. The product consists of a metal body and additional options.
The treatment unit is intended for diagnosis and treatment of ENT conditions. Depending on the equipment
installed, the unit may include ear irrigation, compressed air, suction and cold light.
Operation of the unit requires a power supply and, depending on the equipment installed, water and
drainage connections. Specifications for these can be found in appendix.
The treatment unit is for use in all preliminary examinations of the ear, nose and throat in hospitals or
medical practices. The following table provides an overview of potential indications and contraindications:
Should you require any further information, please contact our sales and service office. Telephone: +49
4191-95379-0
Please examine the treatment unit for any damage during transportation and check that all items are present
immediately on receipt. Check the enclosed delivery note. Failure to do so may result in loss of the right to
replacement. Some accessories are packed within the treatment unit.
2.1 Returns
Any missing parts or incorrect functionality should be reported to the supplier of the treatment unit together
with the invoice, serial number and a precise description of the fault, immediately!
The treatment unit must not be used in areas in which there is a danger of explosion.
A service technician will connect and set up the treatment unit for use after delivery.
Please ensure that building water and power connectors are properly installed by your fitter. Further
information can be obtained from our service department.
A water and power supply connection diagram follows. The dimensions for water connections given in the
diagram below must be adhered to.
Our service technician / medical products advisor will instruct you on operation after installing the device.
3 Safety instructions
The device must be directly connected to a properly installed earthed socket. The supply voltage
must conform to the voltage indicated on the type label. Rooms used for medical purposes must be
equipped with residual current circuit breakers.
Ensure that the device is functioning correctly and in a proper condition before each use. Any
damaged cables or tubes must be replaced immediately. Malfunctions must be reported to the
technical service department without delay.
Avoid spilling liquids or placing used (contaminated) instruments on the treatment unit. If your unit
has a dish for discarded instruments, ensure that instruments are discarded such that no liquids
enter the treatment unit. For further hygiene and care instructions, please refer to our hygiene
booklet.
Do not place used (contaminated) instruments on the unit. Please observe the instructions given in
the hygiene booklet.
The environmental conditions specified in the technical data (section 8.1) must be adhered to.
The suction unit on MODULA units is intended for suctioning liquids in medical areas only. Do not
suction explosive, inflammable or corrosive gasses or liquids. The unit is for use in rooms used for
medical purposes only, but must not be used in areas in which there is a danger of explosion.
The MODULA unit meets the standards for susceptibility to interference set out in EN 60601-1-2
(EMC of medical electrical equipment). The MODULA unit may not be used in conjunction with
devices which do not conform to the standards EN 60601-1 "Medical Electric Equipment" and EN
60601-1-2 "Electromagnetic compatibility (medical electric equipment)".
The warranty does not cover loss or damage occurring as a result of the use of third party accessories or
consumables. Heinemann Medizintechnik is not liable for bodily injury or damage to property in the event
that parts other than original Heinemann parts are used, in the event of failure to observe the instructions for
use given in these operating instructions or if the device has been assembled, reinstalled, modified,
extended or repaired by persons not authorised by Heinemann.
4 Note on operation
Note for units with a glass display: the unit is operated using a
touch-sensitive glass surface, which covers a set of sensors. The
sensors transform touches of the sensor field into a switching
signal. The sensors react to touch with a short delay (in order to Fig. 1: Glass display
avoid unintended touches) and activate the relevant function.
Activation of a function is signalled with a click. After activating a
function, the colour of the sensor field changes from blue to green.
It remains blue for as long as the function remains active.
The treatment unit is switched on via the main power switch (fig. 2)
and is then ready to use.
Models with glass display only: on the Europa and Paris models,
the main power switch is located on the rear of the control panel.
Pressing the main power switch places the unit in stand-by mode.
Fig. 2: Main power switch
To switch the unit into ready mode, touch the on button (fig. 3) for 3
seconds. The unit is then ready to use. The illuminated green
buttons indicate that the unit is ready to use. Only those buttons
which can be activated will be illuminated (i.e. only those options
which have been ordered).
To switch the unit back into stand-by mode, touch the on button for
3 seconds. The buttons will cease to be illuminated and the on
button will be colored blue.
Pressing the button (fig. 4) causes warm air to flow from the
opening. The mirror is warmed at a distance of 3 - 4 cm from this
opening. The mirror heater remains active for about 16 seconds
before switching itself off automatically. In order to avoid a build up
of heat within the casing, the fan continues to run for a further 10
seconds.
The end of the suction tube has an adaptor for either an ear rinsing
bowl or a suction cannula (you have to change the suction
cannula after each patient!). After completing treatment, the
vacuum pump deactivates automatically when the suction tube is Fig. 5: Swivel arm
replaced in the suction tube holder (the 3rd holder form the left on
the swivel arm). Patient secretions are suctioned into a dedicated
reservoir which is located behind the side hatch, where they are
collected until the reservoir is full.
Fig. 7: Fingertip
The end of the suction tube has an adaptor for either an ear rinsing
bowl or a suction cannula (you have to change the suction
cannula after each patient!). After completing treatment, the
vacuum pump is deactivated automatically when the suction tube is Fig. 8: Swivel arm
replaced in the suction tube holder (the 3rd holder form the left on
the swivel arm).
Units built after July 2010 can also be equipped with LED cold light
sources. The LEDs are switched on and off using the same
buttons. LED cold light sources have a brightness control next to
the light outputs on the side hatch as standard.
The medicament sprayers are included with the unit, (optional) Fig. 15: Compressed air handpiece
The hot water irrigation system is primarily used for ear irrigation.
The hot water irrigation system is activated by actuating the water
irrigation button. A temperature indicator continuously displays the
set and actual water temperatures. The top temperature is the
actual temperature, the bottom temperature the factory-set target
temperature (37° C).
Flow rate (max. 500 ml/min) is adjusted using the lever on the
water handpiece (fig. 18). You have to change the water cannula
after each patient!
Flow rate is adjusted using the lever on the water handpiece, max.
400 ml/min. (fig. 21). You have to change the water cannula
after each patient!
Fig.26: Thermostat
Caution! Switch off at the main power switch and unplug the unit from the mains before
cleaning or disinfecting. To check that the unit is not under electrical tension, turn it on
at the main power switch.
Caution! Apply cleaning or disinfectant liquids with a soft cloth, do not pour directly onto
the casing. Extra care is required when using flammable liquids. Do not allow any liquid
to run into the device.
Clean the surface of the MODULA Paris using a soft cloth soaked in a non-aggressive cleaning agent or
disinfectant. Do not use ammonia-containing (e.g. Sidolin) or abrasive cleaning agents, as they will destroy
the painted surface over time. All-purpose cleaners and ethanol are particularly suitable as cleaning agents.
Components should always be subjected to a visual inspection after cleaning, with particular attention paid to
cracks, breaks and mechanical failure. Do not use alcohol-containing cleaning agents when cleaning the
perspex cover.
Note! Please clean the suction tubing at least daily using the optional integrated tube
rinsing system (option).
If your unit is not equipped with an integrated tube rinsing system, take a container containing a non-foaming
disinfectant solution and clean and disinfect the suction system by suctioning this solution up.
The suction reservoir (for manual suctioning) should be cleaned whenever the device is serviced (six
monthly). To do so, open the left side hatch, remove the suction reservoir and clean thoroughly. The
reservoir is resistant to disinfectants.
When using disinfectants, always follow the manufacturer’s instructions with regard to concentration and how
long to leave the disinfectant to take effect.
Caution! Following disinfection, the components of the nebuliser, water jet and silicone
tubing should be rinsed until free of residues.
As with other instruments, all auxiliary devices and associated instruments (e.g. ear irrigation cannulae,
instrument trays, dishes for discarded instruments, etc.) should be regularly sterilised or disinfected. This
includes water jet cannulae, the nebuliser drug vial nebulisers and the silicone suction tubing.
To change the filter, disconnect the two silicone hoses from the filter
and then connect the hoses with the new filter. The flow direction is
not important.
To empty the reservoir, open the left side hatch, remove the lid and
tube, remove the suction reservoir and clean thoroughly (fig. 28).
For hygiene reasons, check the waste bag at the end of every day and dispose of it if it is even part full.
If your unit has one or more cold light sources, a range of lenses can be attached to the cold light adaptor via
an optical cable. The light adaptors have a STORZ connector. Optional detachable light outputs for
connecting Storz, Wolf, Olympus and Pentax connectors are available. The optical cable is simply inserted or
removed. No additional tools are required.
There is a pre-set locking screw beneath the cable connector. This can also be used to adjust the force with
which the locking screw secures the cable. To fix the optical cable more tightly in the connector, carefully
tighten the screw and check the force required. To fix the optical cable less tightly, carefully loosen the
screw.
A range of optional optical cable adaptors (Wolf, Storz, Olympus, etc.) can be ordered separately.
Caution! Always switch off at the main power switch before replacing the halogen lamp.
Unplug the treatment unit at the mains. To check that the unit is not under electrical
tension, turn it on at the main power switch.
Caution! Allow the halogen lamp to cool for at least 15 minutes before replacing, as it
may be very hot.
To remove a halogen lamp, pull off the cable (fig. 31) and then pull
forward out of the bulb fitting. To insert a new halogen lamp, perform
this process in reverse (replacements are included with the device).
After replacing the halogen lamp, replace the console lid and tighten
the two screws.
To prevent blockages or problems in the water system, the waste water filter (fig. 32) should be checked and
cleaned as necessary each time the device is serviced.
Caution! Switch off the treatment unit at the main power switch and unplug from the
mains. To check that the unit is not under electrical tension, turn it on at the main power
switch.
Caution! If your MODULA unit has an internal water supply and you are carrying out work
on the interior of your unit, you must wait 30 minutes to allow the water heater unit to
cool.
The procedure for cleaning the filter is as follows: Unscrew the retaining screws on the rear of the unit using
a screwdriver.
Caution! Always switch off at the main power switch before replacing fuses. Unplug the
treatment unit at the mains. To check that the unit is not under electrical tension, turn it
on at the main power switch.
After unscrewing the retaining screws, the rear hatch can be easily removed to reveal the fuse holder
containing the fuses. A complete electrical circuit diagram, including fuse diagram, is printed on the inside of
the cover.
The blown fuse should be located using the circuit diagram and replaced with an identical fuse (same fuse
rating). Replacement fuses are supplied with the unit.
The fuse holder must be pulled out of its fitting. The holder can then be easily opened using a flat-head
screwdriver. The mini fuse can now be replaced easily (fig. 35, 36). To avoid confusion, remove only one
fuse at a time.
Caution! If your MODULA unit has an internal water supply and you are carrying out work
on the interior of your unit, you must wait 30 minutes to allow the water heater unit to
cool.
22 User`s manual MODULA Paris (HM_TK_GA-Paris_28062013_06_EN)
G. Heinemann Medizintechnik GmbH
MODULA Paris
6 Hygiene
Bear in mind that the tap water used by the unit for warm water irrigation is low in micro-organisms, but is not
sterile. (36 - 42% of nosocomial Pseudomonas aeruginosa infections are traceable to tap water primarily
contaminated at the tap (Source: RKI, Gesundheitsschutz 4/2004). To protect yourself and patients, we
therefore recommend incorporating a downstream sterile filter.
We also offer an optional water purification filter (lifespan 4 weeks) for insertion between the water
handpiece and cannula.
The following basic principles should be observed when working with the ENT treatment unit:
wipe the unit at least daily with a suitable cleaning agent (for recommended cleaning agents, see
page …)
after each patient, replace all instruments, handpieces, instrument trays, etc. used with disinfected or
sterile items (for recommended cleaning agents, see page …)
on units with a water tank, always use fresh, cold tap water only and check the water level in the tank
clean the tube rinsing system with a non-foaming disinfectant daily (for recommended disinfectants,
see page …)
Exact dosing of disinfectants is required for effective disinfection and to prevent selection of micro-organisms
and development of disinfectant resistance. (Source: RKI)
7 Guarantee
We offer a guarantee for all parts of the MODULA treatment unit for 12 months from the date of installation.
Longer guarantee periods may be agreed in your purchase agreement.
The guarantee includes the fastest possible repair by our service department in the even of a fault. For your
own benefit, you should therefore contact us immediately (contact).
The manufacturer holds itself responsible for effects on the safety and reliability of the treatment unit only if:
the room electrical and water systems meet the requirements of IEC-60601
Caution! Repairs to the MODULA treatment unit may only be carried out by G.
Heinemann Medizintechnik GmbH or agents expressly authorised to carry out such work.
8 Annex
Frequency: 50/60 Hz
Classification: IIa
Protection class: I
Air-pressure (option): Compressor oilfree, 12 L/min by 2700 U/min and 138 VA, adjustable from 0,2 to 4,0 bar
Vacuum pump (option): Vacuum pump oilfree, 40 L / min up to -0,85 bar und 150 VA (option: 60 L/min)
Water heater (option): max. 1500 VA (long-term use), minimum water pressure 1,5 bar
Weight: 140 kg
8.2 Figures
1: Water handpiece, 2: Compressed air handpiece, 3: Suction handpiece, 4: Endoscope holder, 5: Quiver for
disinfection, 6: Glas control panel, 7: Mirror heater, 8: Left side cover, 9: Tray for used instruments, 10:
Waste bin, 11: Instrument level with built-in illumination, 12: Swivel holder
1: Stand-By-button, 2: Button „Mirror heater“, 3: Button „Ear rinsing“, 4: Button „Option“, 5: Button „Cold light
sources“, 6: Suction reservoir indicator, 7: Manometer „Vacuum“, 8: Manometer „Compressed air“, 9:
Temperature display for ear rinsing system, 10: Buttons for “Vestitherm”-Option
26 User`s manual MODULA Paris (HM_TK_GA-Paris_28062013_06_EN)
G. Heinemann Medizintechnik GmbH
MODULA Paris
Electrical system
Fuses set STA20-00015
Suction system
Silicon tubes for suction hose (10 pcs.) MOD21-08619
210-0770572
Overflow-/ bacterial filter (for units after 2011), 1 Stück
Cover for secretion glass (manual emptying) with overflow sensor MOD18-05810
Water system
Manufacturer:
E-mail: info@heinemann-ent.de
Web: www.heinemann-ent.de