HEINEMANN MODULA MINI User manual

USER`S MANUAL

ENT Diagnostic & Treatment Unit

MODULA mini

0482

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

Introduction

Thank you for choosing to purchase the MODULA mini 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.

Signs and symbols

Attention!

Attention! Hot!

Dangerous

voltage!

Pull plug before

opening!

Note

Appliance type

Type label for MODULA units

Manufacturer:

G. Heinemann Medizintechnik GmbH, Leibnizstraße 13-15, D-24568 Kaltenkirchen

Phone: +49 4191-95379-0, Fax: +49 4191-9537937, E-mail: [email protected]

Web: www.heinemann-ent.de

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

Contents

Introduction.........................................................................................................................................................3

Signs and symbols..............................................................................................................................................3

1General notes for usage.............................................................................................................................5

1.1 Purpose of the device........................................................................................................................ 5

1.2 Indications / Contraindications........................................................................................................... 6

2Delivery and unpacking ..............................................................................................................................7

2.1 Returns .............................................................................................................................................. 7

2.2 Connecting and setting up the unit.................................................................................................... 7

3Safety instructions ......................................................................................................................................8

4Note on operation.......................................................................................................................................9

4.1 Main power switch ............................................................................................................................. 9

4.2 Mirror warmer .................................................................................................................................. 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

5Maintenance and repair............................................................................................................................17

5.1 Cleaning........................................................................................................................................... 17

5.2 Changing the bacteria filter.............................................................................................................. 18

5.3 Emptying the suction reservoir ........................................................................................................ 18

5.4 Optical cable.................................................................................................................................... 19

5.5 Replacing the halogen lamp............................................................................................................ 19

5.6 Cleaning the water filter................................................................................................................... 20

5.7 Replacing fuses ............................................................................................................................... 22

6Hygiene.....................................................................................................................................................23

7Guarantee.................................................................................................................................................24

8Annex........................................................................................................................................................25

8.1 Technical details.............................................................................................................................. 25

8.2 Figures............................................................................................................................................. 25

8.3 Consumables & spare parts ............................................................................................................ 27

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

1 General notes for usage

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 authorised 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 in Hamburg. Telephone:

+49 4191-95379-0

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 authorised by the manufacturer or if the device is used incorrectly or other

than as described in the operating instructions.

1.1 Purpose of the device

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.

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

1.2 Indications / Contraindications

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:

Ear irrigation:

Cleaning the auditory canal

Vestibular investigations (caloric stimulation of the vestibular system)

Suction:

Suctioning blood (emergency, haemorrhage, post-op)

Suctioning wound exudate post-op

Suctioning of secretions

Cleaning the auditory canal

Cleaning the nostrils and sinuses

Oral suctioning (tonsilar calculi/pus)

Compressed air:

Application of medications (nebulisation), including to surfaces

Performing politzerisation

Light sources:

Illumination during endoscopy, microscopy, investigations involving a

headlight

Ear irrigation:

Perforated eardrum

Cholesteatoma

Chronic otitis media

Episodes of acute vertigo

Otitis externa

Tympanoplasties

Compressed air:

Intracranial injuries

Orbit (eye socket) injuries

CSF fistula

Following middle ear surgery

Sinusitis

Purulent rhinorrhoea

Petrous fracture

Should you require any further information, please contact our sales and service office.

Telephone: +49 4191-95379-0

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

2 Delivery and unpacking

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.

2.2 Connecting and setting up the unit

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 authorised by the manufacturer.

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.

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

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.

Please be aware of the risk of crushing injuries from moving parts.

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.

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

4 Note on operation

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.)

Power and water connections for the treatment

unit must be secure!

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

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.

Fig. 1: Glass display

4.1 Main power switch

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.

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.

Note: always deactivate the unit by touching the

stand-by button before turning off at the main

power switch.

Fig. 2: Main switch

Fig. 3: Glass display

G. Heinemann Medizintechnik GmbH

MODULA mini

User`s manual MODULA mini (HM_TK_GA-mini_28062013_06_EN)

4.2 Mirror warmer

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 warmer 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. Should an excess temperature be detected, a safety

thermostat will deactivate the mirror warmer.

Caution! Do not place any objects or body parts

directly over the opening, as the metal grid can

become very hot.

Fig. 4: Glass display

4.3 Suction with manual emptying (option)

Suction is activated automatically when the suction tube is

removed.

Caution! Please use suitable suction catheters for

suctioning and regulate the volume of flow to

prevent any risk of injury as a result of excessive

pressure focused at a single point.

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

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.

For reasons of hygiene, this reservoir should be emptied daily. The

reservoir will otherwise continue to fill until the overflow prevention

mechanism is triggered. A red warning light on the control panel

indicates that the reservoir is full. The reservoir must be emptied

when this warning light is illuminated.

Fig. 5: Glass display

Fig. 6: Right cover with the

reservoir

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