otometrics HORTMANN Aquamatic II User manual

Aquamatic II
User Guide
Doc. No. 7-50-7500-EN/02
Part No. 7-50-75000-EN

Copyrightnotice
No part of this documentation or program may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any
means, electronic,mechanical, photocopying, recording, or otherwise, without the prior written consent of GNOtometricsA/S.
Copyright© 2015, GNOtometricsA/S
Published in Denmark by GNOtometricsA/S, Denmark
All information, illustrations, and specifications in this manual are based on the latest productinformation available atthe time of
publication. GNOtometricsA/S reserves the right to make changes at any time without notice.
Registered trademarks and Trademarks
MADSENIteraII,MADSENOTOflex 100, OTOsuite, AURICALFreeFit, AURICAL VisibleSpeech, MADSEN Astera², MADSENXeta, ICS
Chartr 200 VNG/ENG, ICSChartr EP, OTOcam300,MADSENAccuScreen, MADSENAccuLink,ICSAirCal, AURICALAud,AURICALHIT,
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Versionrelease date
2015-05-01
107359
Technicalsupport
Please contact your supplier.
2 Otometrics - Aquamatic II

Table of Contents
1 Introduction 5
2 Safety advice 7
3 Installation and start-up 9
4 Operation 16
5 Cleaning 20
6 Maintenance and service 21
7 Troubleshooting 25
8 Accessories and spare parts 26
9 Specifications 27
10 Disposal 29
Otometrics - Aquamatic II 3

4 Otometrics - Aquamatic II

1 Introduction
1.1 Notes on operating instructions
The operating instructions contain important information on how to operate the Aquamatic™ II safely, correctly and effect-
ively. The operating instructions are intended for new operating personnel and also should be continued to be used as a
reference manual. Reading and understanding the operating instructions will assit the user in avoiding risks, reducing repair
costs, lowering down-time, increasing reliability and extending the service life of the equipment. The operating instruc-
tions must always be kept available and near the equipment.
Prior to first use, please read the chapter “Safety advice” to be prepared for any possible dangerous situations. The basic
principles are:
Judicious and careful work provides the best protection against accidents!
Operational safety and readiness for use depend not only on your capabilities, but also on care and maintenance given to
the Aquamatic™ II. Regular cleaning and service work are a must. Major maintenance and repair work should be carried
out only by expert personnel authorized by producer. For repairs, only use the Producer spare parts to preserve the equip-
ment warranty and ensure operational safety, readiness for work and to maintain the value of the equipment.
• The product Aquamatic™ II bears CE Marking CE-0124 according to the EEC guideline of the council for medical
products 93/42/EEC and meets the basic requirements of this guideline.
• The quality management system applied at producer has been certified according to international standards EN ISO
9001 and EN 13485.
• Reprints and text extracts are allowed only with written permission from Producer.
Abbreviations / symbols in these operating instructions
Important•Indicating particularly important advice!
The recommended sequence must be followed in each case!
• Indicating a list
– Subdivision of a list/activity
Describing the effect of an activity.
1.2 Intended use
• Compact unit for stimulation of the vestibule.
Distinguished by its easy operation, it can be used in a hospital and in a practice.
• May also be used for irrigation of the auditory canal during examinations.
• The unit is available with different water flow rates for the stimulation mode and for the irrigation mode. The respect-
ive flow rates are stated on the type plate.
• This unit may not be used if the auditory canal is inflamed or contaminated.
Otometrics - Aquamatic II 5
1 Introduction

• This unit is designed for short-time use on patients.
1.3 Function
• Operating the main switch (Fig. 1 ►10) automatically activates the thermal process for reducing bacterial count (see
Description of modes ►18).
• The unit automaticaly switches to the irrigation mode where the autitory canal can be rinsed with water warmed up
to 37° C.
• The unit operation can be changed to the stimulation mode for stimulating the vestibule with a reduced flow of
water. The Aquamatic™ II is equipped with a timer for preselecting the stimulation time.
1.4 Explanation of symbols
Pay attention to operating instructions ! as to ISO /7000/0434 DIN 30600/1008 IEC 348
Type B equipment as to IEC 417
Fuse as to IEC 417/5016, DIN 30600/0186
Temperature in degree centigrade
Timer adjustment in seconds
Start
Stop
Timer
Cold stimulation level
Warm stimulation level
37°C
37° C Irrigation level (water at a temperature value of 37° C)
6 Otometrics - Aquamatic II
1 Introduction

Heating ON
Heating OFF (energy saving mode)
Control output for connecting a nystagmograph (graphical recorder as to DIN 30600, IEC 417 5192)
Equipotentiality DIN 30600 495, ISO 417 5021
Connection for waste water
Connection for water
Low Reduced flow rate for stimulation of the vestibule
High High flow rate for rinsing the auditory canal
2 Safety advice
• The Aquamatic™ II unit is produced according to IEC 601/EN 60601 and listed in the following classes:
– VDE Class of protection 1
– Class IIa (EEC 93/42).
• The equipment must only be connected to a power outlet with a correctly installed ground/earthing contact accord-
ing to local and state regulations.
• The unit must be installed by a specialist authorized by GN Otometrics (see Connections ►14).
• The Aquamatic™ II may be used in supervised operation by qualified personnel which have been authorized by GN
Otometrics and which have been trained in the operation of the equipment (IEC 601-1/EN 60601-1).
• The mains voltage specified on the type plate must match the power supply system.
• Prior to every use of the equipment, verify that the device is technically safe and in proper working condition.
Damaged leads must be replaced immediately!
• Correct configuration in assembly of country-specific connections
green/yellow protective conductor (PE)
blue neutral conductor (N)
black resp. brown phase (L)
• The control panel must be visible and in reach of the operator. Ensure the equipment is stable prior to use.
• In the thermal process for reducing bacterial count hot water is being ducted through the irrigation handle. Please do
not take the handle from its holder or spray water!
• Metal parts can be hot!
• Prior to spraying, the water temperature must be checked by the user!
Otometrics - Aquamatic II 7
2 Safety advice

• Switch off main power switch after use and close the water valve of water supply.
• The Aquamatic™ II should only be operated in rooms used for medical purposes, and never in areas subject to explo-
sion hazards.
• All additional equipment, which is connected to the analog and digital interfaces of the unit, must meet the require-
ments of relevant EN specifications (for inst. EN 60950 for data processing equipment and EN 60601 for electrical med-
ical appliances). In addition, configurations must satisfy system specification EN 60601-1-1. When additional equipment
is connected to the signal input or signal output section on the unit, the person making the connection is deemed "a
system configuration operator" and as such is responsible for meeting the requirements of system specification EN
60601-1-1. For answers to additional questions, please contact your local specialist supplier or GN Otometrics tech-
nical service.
• The irrigation jet must not come into contact with contaminated material.
• Only use the warm water jet when a tube tip is installed!
• Take caution to avoid injury to the eardrum when introducing the water jet!
• For hygienic reasons jet connections must be changed after each patient. This also prevents retrograde germination of
the warm water system.
• Use only for irrigation of auditory canal!
• GN Otometrics is not liable for personal injury and damage to property if
– original GN Otometrics parts are not used,
– the operating instructions are not completely followed,
– assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorized by
GN Otometrics.
2.1 Important instructions for the maintenance of the hygiene status of warm
water irrigation units
For loosening cerumen in the auditory meatus and for the stimulation of the labyrinthine system, GN Otometrics offers the
warm water unit Aquamatic™ II (20° - 47° C).
The unit, connected to a typical household faucet, heats the drinking water to the preselected temperature. The oper-
ating instructions must be followed, or the increased number of pathogens in the rinse water can affect the health of sens-
itive patients.
Requirement for water used
The water provided by the household faucet must, at minimum, meet the WHO guidelines or the country-specific
guidelines for drinking water.
Connection1
Fresh water must flow through the water faucet for a period of approx. 1 minute prior to the unit being connected.
Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70% alcohol before screw-
ing them into place.
Wear disposable gloves when carrying out maintenance work on parts which come into contact with the water.
Carry out thermal cleaning at least 3 times before patient use.
1This work is carried out by the GN Otometrics service technician.
8 Otometrics - Aquamatic II
2 Safety advice

Runningoperation
Before beginning the surgical operation, switch on the unit and wait for the thermal cleaning process to complete.
After the device had been idle for a long period of time (weekend, during holidays, etc.), the thermal cleaning process
must be initiated and repeated.
We recommend that the device be switched off and on every 2 hours and not longer than 4 hours to start the thermal
cleaning mode.
Immediately replace and autoclave contact parts such as the jet connection each time it is used for a different patient (for
prevention of retrograde contamination).
Before every use, spray water and check the temperature.
Service
Ensure that the suspended particle filter is hygienically changed (see commissioning) (dispose of filter and carefully clean
the filter glass). Ensure that no contact is made with the contaminated parts.
Carry out thermal cleaning after each service.
We recommend that the germ count in the water be regularly determined at the input and output of the unit.
3 Installation and start-up
3.1 Standard delivery
Quantity
1 Aquamatic™ II basic unit
1 Irrigation handle
1 Double-barreled hose
3 Jet connection short, straight (80 mm)
1 Splash protection
1 Rubber bush for splash protection
2 Three-hole gasket
1 Hose tips for jet connection (30 Pcs)
1 G3/4i-G1/4a-screwing (water-tap G3/4 on filter G1/4)
1 Cap nut G3/4
1 Water filter complete
2 Gasket (f.G1/4a) 13x18x1
1 G1/4a-G3/4a-reducer (filter G1/4 on water hose G3/4)
1 Water supply hose G3/4i, L = 3 m
1 Waste water hose G1/4i, L = 3 m
Otometrics - Aquamatic II 9
3 Installation and start-up

2 Gasket (f. G1/4i) 10x15x1
1 Cardboard 455 x 340 x 250 mm
1 Padding for cardboard
1 User Guide
3.2 Illustration
Fig. 1 Front view
A. Main switch
B. Key switch for heating ON/OFF (energy saving mode)
C. Coding switch for warm-stimulation level
D. Coding switch for cold-stimulation level
E. Coding switch for stimulation time
F. Key switch for selecting the irrigation level (37° C)
G. Key switch for selecting the warm-stimulation
level (e.g. 44° C)
H. Key switch for selecting the cold-stimulation level
(e.g. 30° C)
I. Key switch for start/stop of the stimulation
J. Temperature display (two-figure number, res-
olution 1° C), current value indication
K. Display of stimulation time (two-figure number,
resolution 1s)
10 Otometrics - Aquamatic II
3 Installation and start-up

Fig. 2 Rear view
A. Type plate
B. Control output for a nystagmograph
C. Unit plug with fuse compartment
D. Equipotentiality connection
Otometrics - Aquamatic II 11
3 Installation and start-up

Fig. 3 Side view
A. Support for irrigation handle
B. Connection for double-barreled hose
C. Connection for waste water hose*
D. Connection for water supply hose
12 Otometrics - Aquamatic II
3 Installation and start-up

Fig. 4 Irrigation handle
A. Handle
B. Connection for double-barreled hose
C. Three-hole gasket
D. Knurled screw
E. Release lever
F. Valve plunger
G. Jet connection
H. Splash protection
I. Cap
J. Double-barreled hose
K. Lever for water flow
Otometrics - Aquamatic II 13
3 Installation and start-up

3.3 Connections
Fig. 5 Connections
A. Water supply G3/4"
B. Drainage fittings
C. Cold water
D. Min. 20
3.3.1 Electrical connection
• Connect the power cable to the socket on the unit (Fig. 2 ►11, item C).
• Insert the power plug in a correctly installed socket with a ground/earthing contact.
3.3.2 Connecting a nystagmograph
• When controlling an ENG (electro-nystagmograph) or a CNG (computer-nystagmograph) at output (Fig. 2 ►11, item
B), please connect only recording equipment approved by GN Otometrics. Connecting cable available from GN Oto-
metrics (see Accessories and spare parts ►26).
14 Otometrics - Aquamatic II
3 Installation and start-up

• At the end of the stimulation time, a trigger signal for a nystagmograph is available at the rear 3-pole DIN socket. This
outlet is an electrically isolated photo transistor. The emitter connection which has to be connected to the ground
line of the trigger inlet at the nystagmograph is attached to pin 3. The open-collector connection is located on pin 1
and is to be connected to the positive supply voltage (+5 V or +12 V) by means of a pull-up resistance. The maximum
collector voltage of the transistor may not exceed 80 MA.
3.3.3 Equipotentiality connection
• Connection for potential compensation (Fig. 2 ►11, item D).
– Connecting cable available from GN Otometrics (see Accessories and spare parts ►26).
3.3.4 Water connection
• Local requirements:
– Waterfaucet with G3/4" external thread.
– Drinking-water!
– Input water pressure: +2000...+6000 hPa.
– Feed temperature: +7...+19.5° C (recommended), but at least 0.5° C below the required lowest cold stimulation
value.
– Drainage fittings (Art.No. 502.0880.0) as to DIN 1988.
• Connection to water supply and waste water:
– Prior to connecting the unit to the water supply, the feed line must be flushed clean by opening the water faucet
for a minute and allowing free flow of the water.
– Connect the filter unit to the water faucet by means of adapter and gasket.
• Insert the gaskets in the cap nuts of the water supply hose.
• Join the nuts with the filter connection and the unit connection (Fig. 3 ►12, item D).
• Insert the gaskets in the cap nuts of the waste water hose
• Join the nuts with the unit connection (Fig. 3 ►12, item C) and the drainage fittings.
3.3.5 Connecting the irrigation handle
• Insert a "three-hole gasket" (Fig. 4 ►13, item C) in the double-barreled hose and screw the hose (Fig. 4 ►13, item
J) on the unit connection (Fig. 3 ►12, item B).
Important•Use only "three-hole gaskets" or the unit will not function correctly!
• Insert a"three-hole gasket" in the irrigation handle and screw it on the free end of the double-barreled hose.
• Open the water faucet.
Check that all connections are tight.
3.4 Start-up
• Insert the handle in its holder; the jet must point to the rear of the unit.
• Switch on the unit (Fig. 1 ►10, item A).
• The unit will display a test mode with digital numbers "8 8" and an audible signal.
Otometrics - Aquamatic II 15
3 Installation and start-up

• Automatic activation of the thermal process for reducing bacterial count starts. Duration: 5 min.
• When the thermal process is complete, the unit will switch to the irrigation mode (37° C).
• When the irrigation mode is not used (handle is not removed from its support), the unit changes into the energy-sav-
ing mode after 5 min.
Fig. 6 Irrigation handle
A. Lever for water flow
B. Adjusting screw
4 Operation
Before switching on the unit, make sure that the handle is in its holder (jet must point to the rear of the unit).
4.1 Adjusting temperatures
• Number of temperature levels: 3
– One level fixed to 37° C irrigation temperature.
keys below the left and right switches (+)
– Two variable temperature levels (20° C - 47° C) (48° C + 49° C only for testing purposes).
16 Otometrics - Aquamatic II
4 Operation

• Temperate setting by coding switches (Fig. 1 ►10, items Cand D).
– left switch for adjusting the "ten" partition
– right switch for adjusting the "one" par-
tition
– lower keys (+) (keys below the
switches)
increase temperature
– upper keys (-) (keys above the
switches)
decrease temperature
• Standard settings:
Level for irrigation mode 37° C fixed
Level for cold stimulation 30° C
Level for warm stimulation 44° C
4.2 Selecting temperature levels
• After operating the main power switch, the automatic activation of the thermal process begins for reducing bacterial
count, followed by the automatic activation of the temperature level "irrigation mode" (37° C).
• For selecting the desired temperature level, use the respective key (Fig. 1 ►10, items F,G, and H).
Display of the active level by illuminated diodes.
Display of the water temperature (current value) in °C.
4.3 Adjusting stimulation time
• By means of coding switch (Fig. 1 ►10, item E).
4.4 Adjusting flow quantity
• With the lever for water flow (Fig. 6 ►16, item A) you can adjust the flow quantity at the irrigation handle.
• 2 adjusting possibilities:
High Flow quantity for rinsing the auditory canal
Low Flow quantity for stimulating the vestibular organ
• With the adjusting screw (Fig. 6 ►16, item B) you can precisely pre-select the flow quantity.
Important•Periodically check the water flow for the stimulation of the vestibular organ and readjust if necessary.
Otometrics - Aquamatic II 17
4 Operation

4.5 Description of modes
4.5.1 Thermal process for reducing bacterial count
Purpose
Reduction of bacteria count in the warm water circuit to prevent or clear a contaminated system.
Activation
Occurs each time the unit is switched on.
• Condition for starting the correct thermal process for reducing bacterial count:
– The irrigation handle must be inserted in the holder on the side (jet pointing to reverse side of the unit).
If not, a warning signal is given (warning also sounds when the handle is removed during the thermal cleaning
procedure).
Additionally, the error code "F0" is shown (disappears when handle is returned).
Important•In the thermal process for reducing bacterial count, hot water is passing through the irrigation
handle. Please do not take handle from its holder or splash off water!
Important•Metal parts of the irrigation handle and of the double-barreled hose will be hot! Please do not touch
metal parts during the thermal cleaning procedure!
– During the thermal process for reducing bacterial count, the temperature display shows a 'd' on the first segment
and the remaining time (in minutes) on the second segment.
• After cooling down to 37° C the unit will automatically switch into irrigation mode.
4.5.2 Irrigation mode
Purpose
Rinsing of the auditory canal.
Properties
• Temperature: 37° C, permanently set.
• Position of the irrigation handle: High (see Fig. 6 ►16, item A).
Activation
• Automatically after completion of thermal cleaning procedure and taking out the handle or by key (Fig. 1 ►10, item
F).
• When the irrigation mode is not used (handle remainsin holder) the Aquamatic™ II changes into the energy
saving mode after 5 min.
• Reactivation of the irrigation mode by taking the handle out of the holder or activating a key on the temperature con-
trol unit.
18 Otometrics - Aquamatic II
4 Operation

• Repeated activation of the 37° C key affects switching-off of the heating system.
Water with feed temperature is available.
4.5.3 Stimulation mode
Purpose
Stimulation of the vestibule.
Properties
• Temperature: according to pre-set cold or warm water stimulation level
• Position of the adjusting lever: Low (Fig. 6 ►16, item A)
• Duration: as pre-set by means of timer.
Activation
• Initial selection of the type of stimulation is done by actuating either warm-stimulation or cold-stimulation key (Fig. 1
►10, items Cand D) (see Adjusting temperatures ►16 for pre-setting of temperature).
Water with pre-set temperature value flows to handle.
• Wait for 20 seconds.
• Operate the "timer-start-key".
• Preparation for stimulation:
– Operate unit 15 seconds in holding position so that the jet can be positioned correctly in the auditory canal.
Important•During this period, the water is directed, via the handle, into the drain in order to guarantee an optimum
temperature stability; with an optical indication by the flashing figure in temperature display. Do not start stim-
ulation by operating the release lever at the handle until you hear the audible signal!
• Carrying out the thermo-stimulation by actuating release lever at handle (Fig. 4 ►13, item E).
• At the end of the stimulation period a control signal for a recording unit is issued at the nystagmograph output.
• After completion of the stimulation the unit remainsin a holding position for 15 seconds so that the handle may be
removed from the auditory canal.
During this time, water flows into the drain; again an optical indication is made by flashing temperature value.
• Repeated actuation of the "timer-start-key" leads to stopping the timer operation.
• Second actuation of the currently active key affects deactivation of the applicable stage.
Heating is switched off completely.
Stimulation with cold water (feed temperature).
4.5.4 Energy saving mode
Purpose
• Reduction of energy consumption.
Activation
• Actuation of key "heating on/off" (Fig. 1 ►10, item B).
• Heating is switched off after five minutes of non-use of the unit.
Otometrics - Aquamatic II 19
4 Operation

5 Cleaning
5.1 General information on cleaning and disinfection
After use, all parts which come into contact with the patient (rinsing connection, jet connection, hose tips) must be
removed and disinfected or autoclaved! You may use all cleansers and disinfectants listed in section 5.2.
The surfaces of the Aquamatic™ II resist most of the common surface disinfectants.
However, do not use
– disinfectants containing concentrated organic or inorganic acids or bases, since these may cause corrosion damage;
– disinfectants containing chloramides, phenol derivatives or anionic tensides, since these may cause stress cracks in
the plastic material used for the housing of the unit.
For cleaning and disinfection, you may also use disinfectant sprays or disinfectant tissues.
Important•Switch off the unit by the main power switch before starting cleaning and disinfection.
Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. Make sure that no liquid penetrates
the unit. You may use all cleansers and disinfectants listed in Recommended surface disinfectants ►21.
Important•Always observe the instructions for use by the manufacturer of the disinfectants, above all, concentration
specifications.
Important•The above measures for cleaning and sterilizing do not replace the respective precautions for operating
the unit.
5.2 Recommended instrument disinfectants
Disinfectant Ingredients (in 100 g) Manufacturer
GIGASEPT FF
(Application concentrate)
succinic acid dialdehyde 11.0 g Schülke & Mayr,
Norderstedt
dimethoxy tetrahydrofurane 3.0 g
corrosion protection components
non-ionic tensides and odoriphores
Sekusept PLUS (Application
concentrate)
glucoprotamine
non-ionical tensides dissolvents, com-
plexing agents
25.0 g Henkel, Düsseldorf
20 Otometrics - Aquamatic II
5 Cleaning