Huntleigh OBIX BeCA - 2.2. Contraindications; 2.3. Unpacking; Preliminary Checks; 2.4. Operator Positioning

Safety Instructions
6
777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
Do not use if there is any damage to the
device or its accessories.
OBIX BeCA can be isolated from the power
outlet by unplugging the power cord. Ensure
the power cord plug is fully accessible at all
times.
The fetal monitor is a Class 1 product that
relies for safety on its protective earth.
Ensure it is connected to a grounded,
hospital-grade AC power outlet.
If this product is connected to another item
of electrical equipment, ensure that the
system is fully compliant with IEC 60601-
1:2005.
Do not use in the home environment. Do not use in vehicles or in aircraft.
Do not use with electrosurgical devices. Do not expose to excessive heat, including
prolonged exposure to sunlight.
Do not modify the device or its
accessories.
This equipment is for use only by suitably
qualified healthcare practitioners.
When setting up the fetal monitor, consider
and minimize the risk of persons tripping
over cables.
Do not use during magnetic resonance
imaging (MRI) scanning.
The OBIX Freedom will not operate when
OBIX BeCA is running on battery power.
Do not use the fetal monitor on more than
one patient at a time.
Cover the fetal monitor if there is a risk of
fluid ingress when moving or storing OBIX
BeCA.
The risk of cyber attack on the fetal monitor
is negligible. No special means are required
to secure the device or its updates.
The emissions characteristics of this equipment make it suitable for use in individual areas and
hospitals (CISPR 11 Class A). If it is used in a residential environment, (for which CISPR 11 Class
B is normally required), this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as re-locating or
re-orienting the equipment.
1.2. Infection Control
Single use transducer belts are for single patient use only and must not be re-used. For other single use
accessories refer to the user instructions supplied with them.
1.3. Patient Applied Parts
AsdenedinIEC60601-1:2005,thepatientappliedpartsoftheOBIXBeCAFetalMonitorarethe:
• TOCO Transducer • MSpO
2
Sensor • NIBPCu󰀨
• Ultrasound Transducer • MECG Electrodes • FECG Scalp Electrodes
• Patient Event Marker