49
8
Guidance and Manufacturer's
Declaration on EMC
8.1
EMC and essential performance
The
Ambix
activ
pump is intended to be used in electromagnetic
environments such as those specified below:
- Homecare
- Nursing home
- Ambulatory care department in hospital.
The customer or user of the
Ambix
activ
pump must ensure that it is
used in such environments.
The
Ambix
activ
pump is used for parenteral nutrition or for antibiotic
treatments.
Excluded medical and special electromagnetic environments:
- Pediatric, neonatal, adult intensive care units
- Emergency services
- Operating rooms, surgery
- MRI (magnetic resonance imaging)
- X-rays imaging including CT scanner and radioscopy
- Nuclear imaging including PET scanner
- Internal or external radiotherapy
- Curietherapy with implantable radio sources
- Air and ground ambulances
- Proximity with electrosurgical unit, cables and electrodes
The customer or user of the
Ambix
activ
pump must ensure that it is not
used in such environments.
Excluding the cases described in this manual, the pump operation must
systematically be checked by a qualified operator, should the pump be
installed in the vicinity of other electrical devices.
In standard operating conditions (homecare, nursing home and
ambulatory care department in hospital), the essential performance of
the
Ambix
activ
pump is defined as follows:
- Flow rate accuracy
- Occlusion detection
- High priority alarms (empty bag/air detection), door open detection.
In the event of electromagnetic disturbances above the limits defined in
the applicable EMC standards, if the essential performance is lost or
degraded, the consequences for the patient are under infusion.
It is the responsability of the customer or user to check the equipment
before use as described in Section 6, page 40 and to consider the EMC
guidance of Section 8.2, page 50.
