User Manual
44 Pages
Preview
Page 1
AQUASTAR Water Irrigator
User manual* 1639 Instrumentation Difra Version 2.03-E
www.difra.be December 2015
NOTICE
•
(*)Contents of this publication are subject to change without notice.
•
For any informations, comments or suggestions about this manual or any other manual, please contact : INSTRUMENTATION DIFRA Industriestrasse 33 B-4700 Eupen BELGIUM Tel : +32 (0)87 89 80 80 Fax : +32 (0)87 89 80 89 Email : [email protected] Web site : www.difra.be
•
Companies, names, and data used in examples herein are fictitious unless otherwise noted.
•
All rights reserved.
•
No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, unless its entire contents are included.
•
Trademarks are the property of their respective owners.
•
Copyright © 2013 Instrumentation DIFRA
•
Printed in Belgium.
INDEX
INTRODUCTION
4
AVERTISING INTENDED USE AVAILABLE MODELS QUALITY CONTROL CONTACT INFORMATIONS SAFETY INFORMATION
UNPACKING INSTRUCTIONS
7
EXAMINATION OF THE PACKING PACKING LIST EXAMINATION OF THE DEVICE
DESCRIPTION / INSTALLATION / USE
10
DESCRIPTION HARDWARE INSTALLATION
Position in the room
13
USE THE AQUASTAR Cleaning ADVANCED INSTRUCTIONS SOFTWARE INSTALLATION DEVICE STATUS AND CONTROL PANEL
OTHER
34
GUARANTEE AND SERVICE SUPPORT AND SERVICE
APPENDIX LIST OF SYMBOL TECHNICAL SPECIFICATIONS REGISTRATION RETURN REPORT FORM MANUFACTURED BY
37
4
INTRODUCTION
INTRODUCTION AVERTISING You should carefully read this User”s Manual. This User’s Manual contains important notes on how to operate your AQUASTAR water irrigator safely, correctly and effectively. It is intended not only for first time users, but also as a daily reference manual. Familiarizing yourself with the instructions contained in this manual will help you avoid malfunctions, reduce down time and repair costs, and operate the device safely. For these reasons, keep this User’s Manual nearby the AQUASTAR water irrigator at all times. Following the recommended regular maintenance and yearly service will ensure the correct performance of the AQUASTAR water irrigator. Other than regular cleaning, all maintenance and repair work must be carried out only by expert personnel authorized by Instrumentation DIFRA.
INTENDED USE The AQUASTAR water irrigator is a medical device manufactured in Belgium by Instrumentation DIFRA and it is designed to allow qualified personnel to perform bi-thermal caloric irrigations of the patient’s vestibular system. It is designed for caloric stimulation in settings where fresh clean water and proper drainage are available. Its micro-controller based technology makes it very flexible and provides the highest possible accuracy in regulating the temperature of the water media.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
5
INTRODUCTION
AVAILABLE MODELS he AQUASTAR water irrigator comes in two different models, depending on the power supply of the destination country. Ref.
Description
DI 090120-115-I
AQUASTAR 2.0 Water Irrigator 115V
DI 090120-230-I
AQUASTAR 2.0 Water Irrigator 230V
DI 09120-230-F
AQUASTAR 2.0 Water Irrigator 230V, with filter Germlyser
QUALITY CONTROL The AQUASTAR water irrigator bears CE markings 1639 according to the EEC guidelines of the council for medical products 93/42/EEC and meets the basic requirements of this guidelines. The quality management system applied at Instrumentation DIFRA has been certified according to international standards ISO 13485.
CONTACT INFORMATIONS Contact your local distributor or refer to the last page of this User’s Manual for the contact information of the manufacturer. SAFETY INFORMATION The AQUASTAR water irrigator is produced according to IEC 601/EN60601. The irrigator must be connected only to a power outlet with ground contact that has been properly installed and connected. If used in the EU, the AQUASTAR water irrigator must be subjected to a safety-technical inspection according to Instrumentation DIFRA instructions. The AQUASTAR water irrigator is designed to be used in supervised operation by qualified personnel who have been properly trained in the operation of the device (EN60601-1 Ed. 3).
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
6
INTRODUCTION
The AQUASTAR water irrigator must be installed on a flat and stable supporting surface. The front panel of the AQUASTAR water irrigator must be visible by the operator at all times during operation and within easy reach. The main voltage specified on the AQUASTAR water irrigator label must match the voltage of the power supply system. Before each use, make sure that the AQUASTAR water irrigator is in technically safe and good working conditions.
Prior to any irrigation, check the water temperature and pressure. Always switch off the AQUASTAR water irrigator and turn off the water supply when the device is not in use.
WARNING! Do not use the AQUASTAR water irrigator in any areas where there is any risk of explosion, such as areas where oxygen is in use.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
7
UNPACKING INSTRUCTIONS
UNPACKING INSTRUCTIONS EXAMINATION OF THE PACKING The AQUASTAR water irrigator is shipped in a box specifically designed to guarantee the instrument’s safety during shipment. Please keep the original box and packing material to ship back the AQUASTAR water irrigator for scheduled maintenance or for any necessary service. Please inspect the shipping box for evidence of damage. If there is evident damage to the package, you should immediately advise the carrier and your Instrumentation DIFRA representative (refer to the last page of this User’s Manual for the contact information) of the damage and be sure to keep the package in case it is needed in order to substantiate any claim for damage to its contents. Refer to Warranty section for more information.
PACKING LIST 115V Model Quantity
Designation
Part number
1
AQUASTAR water irrigator
DI 090120-115
1
Power cable IEC60320 C19 15A/125VAC
0380,120 (US market)
1
ؾ” pipe for irrigator water supply
X420 TUYAUPLAST
1
ؽ” pipe for irrigator water drainage
X420 FLEXIBLE B
1
Water irrigation handle
DI 140013
1
Accessories Set :
1
1
cannula
ADI 090024
1
Deflector
ADI 090010
1
Silicone tips (50pcs)
ADI 090015
User's manual
Aquastar – User Manual
DI 090120/UM
DI 090120/UM/02.3-E
Instrumentation Difra
8
UNPACKING INSTRUCTIONS
230V Model Quantity
Designation
Part number
1
AQUASTAR water irrigator
DI 090120-230
1
Power cable IEC60320 C13 10A/230VAC
X016 ALIM
1
ؾ” pipe for irrigator water supply
X420 TUYAUPLAST
1
ؽ” pipe for irrigator water drainage
X420 FLEXIBLE B
1
Water irrigation handle
DI 140013
1
Accessories Set :
1
1
cannula
ADI 090024cc
1
Deflector
ADI 090010
1
Silicone tips (50pcs)
ADI 090015
User's manual
DI 090120/UM
230V Model with filter Quantity
Designation
Part number
1
AQUASTAR water irrigator
DI 090120-230
1
Power cable IEC60320 C13 10A/230VAC
X016 ALIM
1
ؾ” pipe for irrigator water supply
X420 TUYAUPLAST
1
ؽ” pipe for irrigator water drainage
X420 FLEXIBLE B
1
Water irrigation handle
DI 140013
1
Accessories Set :
1
2
cannula
ADI 090017
1
Deflector
ADI 090010
2
Filtre Germlyser
ADI 090018
1
Silicone tips (50pcs)
ADI 090015
User's manual
Aquastar – User Manual
DI 090120/UM DI 090120/UM/02.3-E
Instrumentation Difra
9
UNPACKING INSTRUCTIONS
EXAMINATION OF THE DEVICE After opening the shipping box, you should carefully inspect the AQUASTAR water irrigator and all its accessories for evidence of any damage, defect or missing part. If you observe any damage, defect or missing part you should immediately contact the carrier and your Instrumentation DIFRA representative (refer to the last page of this User’s Manual for the contact information). Refer to Warranty section for more information.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
10
DESCRIPTION / INSTALLATION / USE
DESCRIPTION / INSTALLATION / USE DESCRIPTION FRONT PANEL
D
27.0
B2
Aquastar
P
TB TA
M
Ma
TC TD
R Ra
B1
Figure 1 ID Description
Possible values (if applicable)
B1 Temperature selection knob
TA, TB, TC, TD
B2 Irrigation time selection knob
OFF, 20, 30, 40, 50 or 60s
D
Digital display
4 digits
M
Irrigator handle holder
Ma Irrigation water pressure manometer P
Programming button and knob
Time: 0s to 60s Temperature: 0°C to 48°C
R
Pressure regulator
0.5bar to 3bar
Ra Double connector for the irrigator handle
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
11
DESCRIPTION / INSTALLATION / USE
BACK PANEL – 115V Model
E
L
A C1
C2
I
P1
Figure 2 ID Description A Water supply connector, ؾ” C1 NAC bus connector C2 NAC bus connector E
Water discharge connector, ؽ”
I
Main power switch
P1 Receptacle for a IEC 60320 C19 Plug L
Identification label
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
12
DESCRIPTION / INSTALLATION / USE
BACK PANEL – 230V Model
E
A
I C1
C2
L
0
1
F
P1
Figure 3 ID Description A Water supply connector, ؾ” C1 NAC bus connector C2 NAC bus connector E Water discharge connector, ؽ” F
Two fuses (8AT)
I
Main power switch
P1 Receptacle for a IEC 60320 C13 Plug L Identification label
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
13
DESCRIPTION / INSTALLATION / USE
HARDWARE INSTALLATION The irrigator handle and its accessories are very delicate. Be careful when handling them.
Position in the room The Aquastar has to be placed in such a position that when the patient is lied at 30° from the horizontal, both ears are easily reachable with the handle of the Aquastar The examiner should be able to move on each side of the patient to the other side without patient movement to access to both ears. The examiner should have a good view on the computer screen to check results of irrigation in real time. We recommend to install the Aquastar at +- 0.75m of the patient's head in the same axis. This allow a better handling. The maximum distance between the device and ears of the patient should not reach 1.75m. The handle is fixed to the device by a 1.8m coiled pipe. CONNECT THE IRRIGATOR HANDLE Connect the irrigator handle to the AQUASTAR water irrigator via the double connector: align the plug on the handle pipes with the connector on the irrigator (indicated by Ra in Figure 1) and gently push until they engage each other (a “click” sound will confirm the connection).
When not in use, make sure the irrigator handle rests in its support.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
14
Position in the room
INSTALL THE IRRIGATOR HANDLE ACCESSORIES Gently align the irrigator cannula with the tip of the irrigator handle and lock it in place by rotating the cannula clockwise (approximately half a turn) until you start feeling some resistance. DO NOT OVER-TIGHTEN the cannula.
Only use the specific and dedicated cannula for Aquastar. Utilization of other cannula may result in hazardous situations. Gently align the hole in the deflector with the tip of the irrigator cannula and push the deflector towards the irrigator handle until it stops (approximately 13 mm (½”) past the tip of the irrigator cannula).
Do not drop the irrigator handle. If you do, the handle might break, and such damage is considered misuse and is NOT covered by any warranty.
WATER CONNECTIONS The device requests a water inlet and outlet and a power outlet. Pipes provided with the device for the outlet and the inlet request those connexions to be maximum at 1m from the rear of the device. A stop cock will be installed on the water inlet to facilitate the installation and maintenance of the device. The output of the stop cock will be a ¾'' male. In some countries, a anti-reflow/anti-backflow device will be requested between the device and the stop cock.. The water pressure on the Aquastar has to be between 3 and 6 bars. The recommended hardness of water is 15°F. Harder water will generate more calcaerous deposit and the device will request to be cleaned more often. Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
15
Position in the room
A filter (20µm or 5µm) between the device and the water supply is recommended. Pay attention to get minimal pressure of water at the output of the filter. A continuous water flowrate of +-350ml / minute will run through the device, once the device is turn on. The water outlet of the device has to be connected to a water evacuation. This evacuation can be considered as a typical one for a washing machine or dishwasher. The minimum inside diameter of the evacuation pipe of your installation sould be of 25mm to be able to slide to the drain of the Aquastar on a height of a dozen cm. This evacuation should be maximum at the same level as the Aquastar to ensure the water evacuation. Note: some countries require that an anti-reflow/anti-backflow device (indicated by Ar in Figure 4) must be installed between the main water supply and your AQUASTAR water irrigator. If you have any question about whether this requirement is applicable in your country, you should contact your water distribution company. Instrumentation DIFRA also recommends that you install a stop-cock (shut-off) valve (indicated by Ro in Figure 4) between your water supply and your AQUASTAR water irrigator, to allow you to quickly and easily isolate the irrigator from the water supply system.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
16
Position in the room
E
A
0
1
Ro
J2 T
TE
Ar
J1
Figure 4 Use the supplied X420 TUYAUPLAST ؾ” pipe (indicated by T in Figure 4) to connect the AQUASTAR water irrigator to the main cold water supply system (¾” fitting). In order to enable the AQUASTAR to deliver water at 27°C, the maximum input water temperature is 25°C. The pipe is provided with 2 ؾ” standard female connectors (if you need an adapter, they are readily available in most hardware stores). Connect the straight female connector to your main water supply and the L shaped female connector to the AQUASTAR water irrigator inlet connector (indicated by A in Figure 4). Each connector is supplied with a gasket (indicated by J1 and J2 in Figure 4). To prevent any leakage, make sure each gasket is centred in the connector so you do not pinch it while screwing in the connector. NOTE: handtighten the connectors, using care not to cross-thread the connections. Use the supplied X420 FLEXIBLE B ؽ” pipe (indicated by TE in Figure 4) to connect the AQUASTAR water irrigator to the drainage water system (½” fitting). The pipe is provided with 2 ؽ” standard female connector connectors (if you need an adapter, they are readily available in most hardware stores). Connect either connector to your drainage water system and the other to the AQUASTAR water irrigator outlet connector (indicated by E in Figure 4). Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
17
Position in the room
NOTE: hand-tighten the connectors, using care not to cross-thread the connections.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
18
Position in the room
POWER CONNECTION – 115V Model
P1
P2
C
Figure 5 Before connecting your AQUASTAR water irrigator to the electric power supply, make sure you have a properly operating wall outlet that will supply the correct voltage, equipped with an earth plot and protected by a residual-current circuit breaker with overload protection of type A 30mA 16A. The socket will be at maximum 1,5m of the device.
The AQUASTAR water irrigator must be connected to a 115V-60Hz wall outlet (indicated by P2 in Figure 5), with ground connector. Fully insert the IEC 60320 C19 female plug of the supplied 0380.120 power cable (indicated by C in Figure 5) into the appropriate socket of the AQUASTAR water irrigator (indicated by P1 in Figure 5) matching the metal contacts of the socket with the slots in the plug. The maximum power consumption of the AQUASTAR water irrigator is 1500W, 15A. Connect the other end of the power cable to the main power supply outlet.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
19
Position in the room
Aquastar has to be powered through an wall socket with working earth connection. This socket has to be protected by a residual-current circuit breaker with overload protection of type A 30mA 16A
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra
20
Position in the room
POWER CONNECTION – 230V Model
0
1
P1
P2
C
Figure 6 Before connecting your AQUASTAR water irrigator to the electric power supply, make sure you have a properly operating wall outlet that will supply the correct voltage v equipped with an earth plot and protected by a residual-current circuit breaker with overload protection of type A 30mA 16A.
The AQUASTAR water irrigator must be connected to a 230V-50Hz wall outlet (indicated by P2 in Figure 6), with ground connector. Fully insert the IEC 60320 C13 female plug of the supplied X016 ALIM power cable (indicated by C in Figure 6) into the appropriate socket of the AQUASTAR water irrigator (indicated by P1 in Figure 6), matching the metal contacts of the socket with the slots in the plug as well as the shape of both enclosures. Connect the other end of the power cable to the main power supply outlet.
Aquastar – User Manual
DI 090120/UM/02.3-E
Instrumentation Difra