Entermed B.V.
Enthermo water irrigators
Series 301 & 304
User/Service Manual
REF.: CE-O1S111-98
Edition I
Entermed BV
De Bouw 141
3991 SZ Houten
The Netherlands
Tel: +31 30 - 221 9600
Fax: +31 30 - 221 9609
Email: postmaster@[Link]
Contents
1. INTRODUCTION ................................................................................................................................. 3
1.1 Introduction ................................................................................................................................. 3
1.2 Applications ................................................................................................................................. 3
1.3 The technical workings of the Enthermo .................................................................................. 4
2. OPERATING THE ENTHERMO ......................................................................................................... 6
2.1 Explanation of the operating components ............................................................................... 6
2.2 Explanation of the operating components (table top models only) ...................................... 6
2.3 Operating the Enthermo ............................................................................................................. 7
3. INSTALLATION AND TESTING ......................................................................................................... 9
3.1 Installation of the Enthermo....................................................................................................... 9
3.2 Testing the Enthermo ................................................................................................................. 9
4. MAINTENANCE .................................................................................................................................. 9
4.1 Cleaning procedure .................................................................................................................... 9
5. WARRANTY ...................................................................................................................................... 10
5.1 Safety requirements and standards ........................................................................................ 10
6. Technical specifications ................................................................................................................. 11
7. Trouble-shooting ............................................................................................................................. 12
Appendix A: Stuklijst .......................................................................................................................... 13
Appendix B: Technical drawings ....................................................................................................... 14
I M P O R T A N T .................................................................................................................................. 27
1. INTRODUCTION
1.1 Introduction
The Enthermo 301 series is a warm water irrigator for cleaning the auditory canal of the ear. The
Enthermo 304 series is suitable for both cleaning the ear and caloric simulation (vestibulum
stimulating). The 301 series is factory set to warm the water to a temperature of 37°C (Degrees
Celsius). The 304 series is equipped with 3 settings 30°C, 37°C and 44°C allowing the user to select
the required temperature. When none of the temperature selection buttons are engaged cold water is
emitted from the device. The Enthermo is produced in accordance with the current IEC regulations
and has been approved and certified by KEMA (0344) notified body in accordance with the European
Directive 93/42/EEC.
1.2 Applications
The Enthermo emits a stream of water at the set temperature. The two applications of the device are
as follows:
-301 series for cleaning the auditory canal of the ear
-304 series for cleaning the auditory canal and caloric testing (caloric simulation)
Both series are available in the form of a table-top model or for integration in Entermed treatment
units. Two autoclavable cannulas are supplied with each device: a bayonet and straight type.
1.3 The technical workings of the Enthermo
Diag. 1
The Enthermo is connected to the water supply and drain. It uses the tap water pressure as a means
of forcing the water under pressure through the cannula. It is therefore vital that the tap water
pressure is at least 2.0 bar and constant but it must not exceed 6 bars. The Enthermo
incorporates a continuous water flow system. This means that the water continuously flows through
the device when it is switched on, even when the triggers is released at which time the water is
diverted down the drain. The tap water enters through the inlet in the back of the Enthermo (or
treatment unit). The water travels through the system via the various components as follows: cold
water inlet -solenoid valve -pressure switch -regulator -manometer -heating element -(when the lever
is pushed) handpiece or via the outlet down the drain.
When the device is switched off the solenoid valve closes off the water circuit. The pressure switch
protects the device against fluctuating tap water pressure or a drop in tap water pressure by shutting
down the power supply. The regulator must only be used to set the water pressure to 1.8 bar, which is
the correct operating water pressure. The manometer gauges the working water pressure and read
1.8 bar when the device is switched on. The heating element is equipped with a safety thermostat that
ensures the device automatically cuts out should the water become too warm. If the thermostat is
activated it will reset itself after approx 15 minutes when the heating element has cooled down. In
normal use this should not occur. A sensitive sensor is incorporated in the heating element for precise
regulation of the water temperature.
Diag. 2
The water flows through the circuit from the heating element to the handpiece. The handpiece
incorporates two tubes, a black one and a blue one. The blue tube carries the water to the three-way
valve. When the lever in the handpiece is pressed the water is diverted through cannula under
pressure. When the lever is released the black tube carries the water away to the drain. The
handpiece is equipped with a light for use in a dark room to locate the auditory canal.
2. OPERATING THE ENTHERMO
2.1 Explanation of the operating components
When the temperature setting is changed by pressing one of the temperature selection buttons
located in the front of the device or the control panel of the Entermed treatment unit, the Enthermo 304
series requires approx one minute to reach the selected temperature.
For safety reasons the Enthermo is equipped with a thermostat to protect against overheating and a
pressure sensitive cut-out switch.
2.2 Explanation of the operating components (table top models only)
The front and back of the Enthermo 304T table-top mode! are illustrated below and the various
components are labelled. Model 301 T is similar except for the temperature selection switches and the
digital temperature display which are excluded. The 301 T is fitted with a power indication light.
Diag. 3
2.3 Operating the Enthermo
Function controls
1 .Syringe lever
The syringe lever is used to adjust the water pressure.
2. Syringe handpiece
A three-way valve in the syringe handpiece allows the water to be diverted through the cannula
whenever the lever is pressed. When the lever is released, the water flows through the circuit and
exits the device through the outlet down the drain. The continuous flow system prevents bacteria
growth and ensures that the water remains at the set temperature at all times.
3. Pressure manometer
The pressure manometer indicates the working pressure (pressure of the water released from the
handpiece). The working pressure is factory set at 1.8 bar. The reduction valve keeps the pressure
constant. The minimum tap water pressure required to operate the Enthermo is 1.8 bar.
4. Digital display (304 series) / power indicator light (301 T)
The digital display indicates the actual water temperature. The power indicator light indicates that the
mains power is on.
5. Temperature selection buttons
Temperature can be selected as follows: 30°C, 37°C, 44°C.
6. 230V/50 Hz power entrance
Mains connector for power lead. Only the power lead supplied should be used.
7. Fuse holder (slow blow 6.3 A, 250 V)
Should a fuse require replacing, the fuse cover should be removed with a flat screwdriver to reveal the
two fuses located behind the cover. The fuses should be replaced with ones of the same type and
rating (slow blow 6.3 A, 250 V).
8. On/off power switch
Power switch for switching the device on and off.
9. Potential equalisation terminal
The potential equalisation terminal can be connected to the hospital's central equalisation circuitry if
this is available.
10. Cold water inlet
Cold water inlet for connection to a cold water supply. Supplied hose is fitted with a 3/8" threaded
connector.
11. Water outlet
Water outlet for connection to the drain. Supplied hose is fitted with a 3/8" threaded connector.
3. INSTALLATION AND TESTING
IMPORTANT
Before switching on the device make sure the water supply is connected to the Enthermo and
there is sufficient water pressure (min. 2.0 bar). The device will not function if the tap water
pressure is insufficient.
3.1 Installation of the Enthermo
Connect the Enthermo to a cold water supply and drain with the hoses provided. Make sure the water
supply is clean and free from particles and air bubbles. An in-line filter and anti lime-scale device are
recommended. These are available from Entermed. Pay special attention to water purity in new
buildings. If drinking water supply is available, the device should be connected to this. Plug the power
lead into a 230V/50 Hz earthed socket. Only use the power lead supplied with the device. If required
the Enthermo can be connected to the hospital's potential equalisation circuitry.
3.2 Testing the Enthermo
Turn on the water supply and check for leaks. Switch on the mains power on the back of the device.
The manometer should now read 1.8 bar. An intermittent audio signal will sound until the device has
reached the set temperature, which this takes about one minute. When the Enthermo is in use the
cannula supplied with the device must be in place. Only use the supplied cannula, otherwise the water
flow (300 ml/min) will not be correct for the factory setting of the device and a change in temperature
may occur.
4. MAINTENANCE
The cannula needs to be de-scaled regularly by placing it in a suitable and non-toxic de-scaling
solution in accordance with the manufacturer's instructions. De-scaling should be done more often in
areas where the tap water is particularly hard. Lime scale deposits can have an effect on the rate of
water flow through the device. This can effect the temperature accuracy and in some case can cause
the device to malfunction.
4.1 Cleaning procedure
301 T /304 T models:
The outer casing consists of a metal chassis with a poly-urethane cover.
301-i/304-i model:
The outer casing consists of metal with an epoxy finish.
All models should only be cleaned with a damp cloth. A mild domestic detergent or soap may be used
to remove stains and dirt.
Do not drench the device with water. Abrasive and aggressive cleaning chemicals must be
avoided.
5. WARRANTY
The Enthermo carries a 12 month warranty in compliance with the supplier's general conditions of
sale.
5.1 Safety requirements and standards
WARNING
The Enthermo does not contain any user serviceable parts.
Only technical personnel authorised by the manufacturer may perform repairs and calibrate Enthermo
devices. Never attempt to repair the Enthermo yourself.
This type of equipment must be earthed.
6. Technical specifications
Classification : Class I
Type : B
(according to IEC 601-1)
Classification : Class IIa
(according to European Directive 93/42/EEC)
Norm : IEC 601-1
Power supply : 230 V 1 60 Hz
Power consumption : 1400 W
Temp. Tolerance : :!: 0.6 °C
Min. water pressure : 2.0 bar
Max. water pressure : 6.0 bar
Working pressure : 1.8 bar (180 kPa)
Max. water flow : 300 ml/min
Time to reach set temperature : 60 seconds max.
Water hose fittings : 318"
Dimensions : W x H x D = 250 x 120 x 400 mm
Weight : 4500 g
Transport and storage the environmental conditions:
Ambient temperature : min. 0 °C -max. 50 °C min.
Relative humidity : 30 % -max. 90 %
Atmospheric pressure : min. 700 hPa -max. 1060 hPa
After transport and storage allow the device to acclimatize for at least 24 hours before use.
7. Trouble-shooting
A) No pressure reading on manometer:
Check:
1) fuses rating: slow blow 6.3 A, 250 V
2) mains power supply 230 V I 50 Hz
3) water supply pressure Should be min 2.0 bar
B) Water does not reach set temperature:
Check:
1) water inlet Should be min 2.0 bar
2) outlet for blockage
3) water pressure stability
C) Water temperature fluctuates
Check:
1) manometer Should be 1.8 bar
2) cannula for blockage (correctly in place)
3) water pressure stability
D) When "73" appears in the digital display, the sensor is malfunctioning and your the device should
be returned to your local Entermed service centre.
In the event that none of the above suggestions are the cause of the problem, contact your
local supplier. Do not attempt to repair the device yourself. A copy of the circuit diagrams for
the Enthermo are available upon request.
Appendix A: Parts list
ENTHERMO PARTS LIST
Position Order code Description
1 ENTH0006 Complete housing
2 793308 Screws (Stainless steel m3*8)
3 108615 Main printed circuit board
4 108616 Filter circuit
5 431002 Nylon support
6 439002 MSTB 2.5 / 4 pieces
7 572200 Buzzer (SL11)
8 793206 Screws (stainless steel M2*6)
9 511001 Crimp sleeve 1.6 mm black
10 548602 Crimp terminal
11 548601 Crimp housing 2 way
12 474004 Clip (heat sink)
13 659046 Adaptor nipple
14 108005 Cooling plate
15 577005 Cable ring 9.5*15.9
16 577004 Cable ring 4*9.5
17 793306 Screw (stainless steel M3*6)
18 797003 Hex nut (Stainless M3)
19 903059 Spacer AZT-5-VM-M3-70
20 108619 Heating element assembly
21 108620 Solenoid valve assembly
22 578001 Cable tie 150*3.5
23 806004 Flat sealing ring
24 789408 Countersunk screw (M4*8)
25 673154 O-ring NBR 36624 8*2
26 653002 Brass filter
27 673218 O-ring NBR 36624 11*2
28 108044 Nickel plated connector
29 676004 PU tube 4*2 blue
30 676005 PU tube 6*4 blue
31 646050 KIKIP 6*1/8
32 646060 TKI 6
33 646108 RIKIP 6*1/4
34 -- RIKIP 4*1/8
35 646028 ROKI 4*1/8
36 688005 One way valve
37 108041 Filter holder nickel plate
38 646027 RIKIP 6*1/8
39 108040 Filter closer
40 789308 Counter sunk screw M3*8
41 659011 Connector ring
42 659038 Nut ¼
43 548209 Filter 6A medical
44 401001 Earth potentiel terminal
45 405017 Cup black 17.5 mm Heyco
46 646051 KIPI 4*1/8
47 656001 Manometer 4 bar
47 656001 Bracket for manometer
48 789408 Counter sunk screw
49 108623 Display connection
Appendix B: Technical drawings
Entermed BV
IMPORTANT
ENTHERMO ear irrigation devices (all models)
1. Before plugging the ENTHERMO into the mains power supply make sure the inlet
and outlet water hoses are connected to the water supply and drain outlet. Then turn
on the water supply.
2. Check the hoses for leaks.
3. The supply water pressure should be at around 2.5 bar (min. 1.8 bar) and constant.
4. Incorporated in the device are two safety switches: a pressure safety switch for water
pressure deficiency and a thermostat for protection against overheating of the
element. If either of these switches are activated it will take approx 30 minutes before
the device resets automatically.
5. Always use the ENTHERMO with one of the cannulas supplied in place because the
device is calibrated for this specific cannula. The standard cannula has a gauge of
0.8 mm internal diameter.
6. Never attempt to repair or calibrate the ENTHERMO yourself. It has been calibrated
using special equipment.
In the event of a breakdown contact your local Entermed dealer.