10.2. REPAIR AND SERVICE OPERATIONS
Repairs and service can be only done by a GCE certifi ed person who also holds all necessary
certifi cates in compliance with national standards for mounting and repair of dedicated gas
devices.
For information about a service in your area please contact GCE or distributor of GCE product.
Usually the combination valves can be repaired while fi tted on the cylinder.
Repair that do not need to be done by certifi ed personnel include exchange of the below
mentioned components:
•
guard,
•
labels,
•
protective covers and separable hose adaptors.
No parts of the equipment shall be serviced whilst in use with the patient.
All labels on the equipment must be kept in good, legible condition by the provider and the
user during the entire product life time.
Use only genuine GCE components.
Any product sent back to GCE (or GCE authorised centre) for repair or maintenancea shall be
properly packaged to prevent contamination or damage during storage, transportation and
handling.
For product to be repaired, the fault short description or some reference to a claim nr. should
be indicated.
11. TECHNICAL INFORMATION
The device Manómetro Digital compiles with the following electrical standards
Electrical safety:
EMC:
Ingress protection:
The valve E-Ministar is adequate for use in hospital and ambulance care, etc. Avoid use in
the vicinity of devices with high intensity of electromagnetic disturbance, such as magnetic
resonance, VF surgical tools, etc. Device does not included any wires or transmitters which
would lead to increase of EM emissions or decrease of EM endurance of the device. Essential
performance of the device may be worsened by the electromagnetic disturbance.
Essential performance of the device may be worsened by the electromagnetic disturbance.
Medical electrical devices require special safety measures concerning electromagnetic com-
patibility and it is necessary to install them and put them into operation according to the
information on electromagnetic compatibility stated in this document.
Portable and mobile radio frequency communication equipment may negatively a ect medi-
cal devices.
The Manómetro Digital may be interfered with by other equipment, even if that other equip-
ment complies with CISPR emission requirements.
The Manómetro Digital should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the E-Ministar should be observed to verify normal op-
eration in the confi guration in which it will be used.
The device provides indication only and is not intended to provide monitoring or alarm func-
tions in a life-sustaining context. The monitoring functions can fail without producing an unac-
ceptable risk and therefore the device does not contain any essential performance which is
required to be maintained under fault conditions.
EN 60601-1 as amended
EN 60601-1-2 as amended
EN ISO 60529, IP 65
13/56
EN