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Summary of Contents for HEINEMANN MODULA Europa
- Page 1 Users manual ENT Diagnostic & Treatment Unit MODULA Europa...
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Page 2: Introduction
MODULA Europa Introduction Thank you for choosing our MODULA Europa 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 the information on the following pages, relate to a MODULA unit fitted with all optional functions of equipment. -
Page 3: Signs And Symbols
Applied part Applied part Do not look into UV radiation! Type B Type BF the light source! Type label MODULA Europa Manufacturer: G. Heinemann Medizintechnik GmbH, Leibnizstraße 13-15, 24568 Kaltenkirchen Phone: +49 4191-95379-0, Fax: +49 4191-9537937, Email: info@heinemann-ent.de Web: www.heinemann-ent.de HM_TK_GA-Europa_07042020_15_EN... -
Page 4: Table Of Contents
G. Heinemann Medizintechnik GmbH MODULA Europa Table of contents Introduction ................................. 2 Signs and Symbols ............................. 3 General Notes for Use ..........................5 Intendend use ............................ 5 Indications / Contraindications ......................6 Delivery and Unpacking ..........................6 Claims ..............................7 Installation ............................ -
Page 5: General Notes For Use
The MODULA ENT treatment unit may only be used by qualified persons to guarantee appropriate usage of the device. Only persons who have been instructed for correct usage of the device are allowed to use the device. Instructions may only be given by persons who were authorized by G. Heinemann Medizintechnik GmbH. -
Page 6: Indications / Contraindications
G. Heinemann Medizintechnik GmbH MODULA Europa 1.2 Indications / Contraindications The treatment unit is for use in all transient examinations of the ear, nose and throat in hospitals or medical practices. The following table provides an overview of potential indications and contraindications:... -
Page 7: Claims
2.2 Installation Caution! G. Heinemann Medizintechnik accepts no liability for the safety or proper function of the device where it has been installed, extended or repaired by persons who have not been authorized by the manufacturer! - Page 8 G. Heinemann Medizintechnik GmbH MODULA Europa Water connection / water inflow: To an easily accessible ½“ angle valve with a 3/8“ x 10 mm compression fitting or a ½“ WAS valve with ¾“ outlet It must be possible to easily turn off the water flow (without tools) ...
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Page 9: Safety Instructions
Rooms used for medical purposes must be equipped with residual current circuit breakers The power cord may only be replaced or repaired by authorized technical staff from G. Heinemann Medizintechnik GmbH or local authorized representatives ... - Page 10 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 authorized by G.
- Page 11 Suction system: When fluids or solids are vacuumed into the vacuum pump due to a failure, you must contact Heinemann Medizintechnik authorized technical staff. In this case, the suction system must be repaired by authorized technical staff, incl. replacement of vacuum pump and tubes.
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Page 12: Operation Instructions
G. Heinemann Medizintechnik GmbH MODULA Europa 4 Operation instructions The treatment unit should be inspected and its proper function checked daily prior to being used with patients (tubes, cable connectors, display instruments, cleanliness, etc.) Proper power and water connections of... -
Page 13: Suction System With Manual Emptying
G. Heinemann Medizintechnik GmbH MODULA Europa Should a high temperature be detected, a safety thermostat will deactivate the mirror heater. Caution! Do not place any objects or body parts directly over the opening, as the metal grid can become very hot! Fig. -
Page 14: Suction System With Automatic Emptying „Sekretomatik" (Option)
LED (Fig. 11). Please check the suction bottle (open side cover, Fig. 12) and empty Fig. 11 the suction bottle manually. If the defect occurs again, please contact Heinemann Medizintechnik authorized technical staff. HM_TK_GA-Europa_07042020_15_EN... -
Page 15: Tube Rinsing System (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa Optional manual suction pressure control, allowing the required suction pressure to be controlled using a control knob. Caution! If you use the extraction system to remove cerumen, pay attention to the choice of the appropriate cannula, and to the noise level in the patient's ear. -
Page 16: Cannula Rinsing System With Disinfection Solution (Option)
(only possible with original Heinemann accessories). This second suction hose is located separately, in the space provided in the swivel arm (Fig. 16). -
Page 17: Compressed Air System (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa 4.9 Compressed air system (option) The compressor is activated when the unit is switched on. It compresses air into a compressed air reservoir until the fixed or required pressure is achieved. The air pressure (bar) is displayed on the right manometer (Fig. -
Page 18: Autonomous Ear Irrigation With Water Tank (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa Caution! The water jet must not be directed directly at the eardrum. Flow rate (max. 500 ml/min) is adjusted using the lever on the ear irrigation handle (Fig. 21). You have to change the water cannula... -
Page 19: Cold Light Sources, Halogen (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa Caution! The water jet must not be directed directly at the eardrum. Flow rate is adjusted using the lever on the water handle, max. 500 ml/min. (Fig. 24). You have to change the water cannula after... -
Page 20: Cold Light Sources, Led (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa Caution! Never direct the light beam directly into the eyes! Always use a light output adapter (Storz, Olympus, Pentax, Wolf) on the light source side, otherwise the heat-absorbing glass or the lens could be damaged. -
Page 21: Sensor Control For The Light Sources (Option)
Endoscope holders are preheated to a preset temperature of +37° C. Adjustment of temperature can and only may be performed by authorized technical staff of G. Heinemann Medizintechnik GmbH or local representatives. Endoscope holders are also available without preheating system (optional). -
Page 22: Storage Quivers For Used Endoscopes
G. Heinemann Medizintechnik GmbH MODULA Europa 4.16 Storage quivers for used endoscopes The storage quivers can be filled with liquids (for example cleaning/ disinfecting solutions) and Endoscopes can be stored in. The particular shape of the quivers avoids contamination of endoscopes and surroundings. -
Page 23: Pre-Heated Instrument Level (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa 4.17 Pre-heated instrument level (option) If your unit has a preheated instrument level, you can store your instruments in the tray and warm them (Fig. 34). The preheating takes place only at the top instrument level, and is factory set to approx. -
Page 24: Uv-Hygiene Drawer (Option)
The disinfecting effect of the UVC sterilization drawer has not been validated by Heinemann Medizintechnik. It is based on the manufacturer's information (in the case Purion® GmbH) and theoretical basics of UV light treatment. - Page 25 G. Heinemann Medizintechnik GmbH MODULA Europa Note! Place the instruments behind and next to each other and do not stack them, otherwise the UVC radiation will reach surfaces! instruments to be treated should not exceed a height of 3.8 cm, otherwise they will hit the upper...
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Page 26: Maintenance And Repair
G. Heinemann Medizintechnik GmbH MODULA Europa 5 Maintenance and Repair The treatment unit should be serviced annually! As a medical device user, you are required to have a safety inspection carried out once a year by us or by one of our authorized companies. -
Page 27: Emptying The Secretion Glass
G. Heinemann Medizintechnik GmbH MODULA Europa The filter are to be found near the secretion glass, behind the left side door (Fig. 41). To change the filter, remove the two silicone hoses from the filter and then connect the hoses to the new filter. -
Page 28: Replacing The Waste Bin
G. Heinemann Medizintechnik GmbH MODULA Europa 5.4 Replacing the waste bin For hygiene reasons, check the waste bag at the end of every day and dispose it even when it is only partly filled. Caution! Pay attention to the proper disposal of contaminated waste! Always use glove when handling waste. -
Page 29: Replacing Halogen Light Bulbs (Option)
G. Heinemann Medizintechnik GmbH MODULA Europa There is a pre-set locking screw beneath the light 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. -
Page 30: Hygiene
the treatment unit is used in accordance with these operating instructions Caution! Repair and maintenance of the MODULA treatment unit may only be carried out by G. Heinemann Medizintechnik GmbH or agents expressly authorized to carry out such work. HM_TK_GA-Europa_07042020_15_EN... -
Page 31: Annex
G. Heinemann Medizintechnik GmbH MODULA Europa 8 Annex 8.1 Technical data Power supply 230 V, 50 Hz Current consumption: max. 10A Power consumption: max. 2,3 kVA Classification acc. 93/42/EEC: Protection class: B: ear irrigation handle, suction handle; BF: compressed air handle,... -
Page 32: Pictures
G. Heinemann Medizintechnik GmbH MODULA Europa 8.2 Pictures 1: Ear irrigation handle, 2: Compressed air handle, 3: Suction handle, 4: Endoscope holders, 5: Quivers for used endoscopes, 6: Control panel, 7: Mirror heater, 8: Tray for used instruments, 9: Waste bin, 10:... -
Page 33: Consumables And Spare Parts
G. Heinemann Medizintechnik GmbH MODULA Europa 8.3 Consumables and spare parts Product description Light system Replacement lamp 150 VA (halogen) MOD10-02701 Cold light cable, 90°, l = 180 cm 0150-30000 Cold light cable, 0°, l = 180 cm 0150-30100 Light cable adapter, endoscope side (Storz, Wolf…), 1 pc 0150-31000 Light cable adapter, light source side (Storz, Wolf…), 1 pc... - Page 34 G. Heinemann Medizintechnik GmbH MODULA Europa 0120-50300 Overflow-/ bacterial filter (for units after 2011), 1 pc Adapter for suction hoses (autoclavable) 0120-50250 Fingertips for the temporary reduction of the suction performance 0120-50100 (100 pcs.) Nose olives (metal), adapted on the suction hose, small...
- Page 35 G. Heinemann Medizintechnik GmbH MODULA Europa Splash guard for the ear irrigation handle 0130-50030 Ear rinsing bowl, adaptable to suction hose 0130-50000 Spit bowl, adaptable to the suction hose 0130-50010 Air pressure system Politzer olives (plastic) for adaption to the handle for compressed...
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Page 36: Electromagnetic Compatibility (Emc)
It is highly unlikely that other electric devices are interfered by Modula Europa. RF emissions CISPR 11 Class B Modula Europa is suitable for use in all facilities which are connected to public power networks which also supply Harmonic emissions IEC 61000-3-2 Class B residential buildings. -
Page 37: Guideline And Declaration - Electromagnetic Compatibility
(60% dip in U industrial/healthcare facilities short interruptions, voltage for 5 cycles for 5 cycles If the user wishes to use Modula Europa variations on power supply input during power interruptions, the Modula lines according to IEC 61000-4- 70% U... -
Page 38: Recommended Separation Distances Between Portable And Mobile Rf Communications
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the locations in which the Modula Europa is used exceeds the applicable RF compliance level above, the Modula Europa should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Modula Europa. -
Page 39: Disposal
G. Heinemann Medizintechnik GmbH MODULA Europa Separation distance (d) according to frequency of transmitter in (m) Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz of transmitter (W) d = [3,5 / 3] √P d = [3,5 / 3] √P... - Page 40 (see hygiene management brochure). As an alternative, the device may be returned to the manufacturer (G. Heinemann Medizintechnik GmbH) who will take care of proper disposal. Inappropriate handling of used devices can have negative effects on the environment and on human health.
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