D-0128227-A – 2020/12
Aqua Stim Water Irrigator – Instructions for Use - US
Page
3
2
Unpacking and installation
2.1 Unpacking and inspection
Check for damage
When the instrument is received, ensure that you have received all the components on the shipping
checklist. All the components should be checked visually for scratches and missing parts before use. All the
contents of the shipment have to be checked for their mechanical and electrical functioning. If the equipment
is found faulty, please contact your local distributor immediately. Keep the shipping materials for the carrier’s
inspection and insurance claim.
Keep carton for future shipment
The instrument comes with shipping cartons, which are specifically designed for the components. It is
recommended to keep the cartons for future shipments in case of any need for return or service.
Reporting and returning procedure
Any missing part or malfunction or any damaged components (due to shipment) should be reported
immediately to the supplier/local distributor along with the invoice, serial number and a detailed report of the
issue. For any on-site service-related information, please contact your local distributor. If the system/
components are to be returned for service, please fill all the details related to product issues in the
‘Return
Report’
, which is attached to this manual. It is very important that you describe all the known facts about the
issue in the return report, as this will help the engineer to understand and solve the problem to your
satisfaction. Your local distributor holds the responsibility for coordinating any service/return procedure and
related formalities.
2.2 Storage
Environmental conditions
The Aqua Stim is not suitable for use in the presence of flammable
anesthetic mixtures with air or oxygen or nitrous oxide as there may be an
explosion risk.
Standards Compliance
•
Class I device for protection against electric shock
•
Type B Applied Part for degree of protection against electric shock
•
IPX0 rating for degree of protection against the ingress of water
(I. e. the system will be damaged if any water is absorbed by the electronic equipment)
The Aqua Stim was tested according to IEC60601-1-2 regarding EMC. Thus, one can install and use the
Aqua Stim in a clinical exam room where other medical equipment is located.
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided.
•
Portable and mobile radio frequency (RF) communications equipment (e. g. cell phones, personal
data assistants, etc.) can affect medical electrical equipment. This equipment should not be used at
close distances to the equipment
•
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment
Performance Conditions
Storage
Transport
Temperature
20°C ~ 30°C
68°F ~ 86°F
1°C ~ 50°C
34°F ~ 122°F
-15°C ~ 50°C
5°F ~ 122°F
Relative Humidity
10% ~ 90%
10% ~ 90%
10% ~ 95%
Non-condensing
Non-condensing
Non-condensing
