D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN
Page
19
3.12 Charging and powering Sera
TM
3.12.1 The battery
The instrument is powered by a rechargeable Lithium-ion (Li-ion) battery. The battery is charged by placing
the instrument in the AC powered cradle.
The battery can also be charged by:
•
Connecting the instrument to a powered PC using the supplied USB cable. Charging this way will be
slower than charging with the cradle.
•
Connecting the device to mains using the power supply from the cradle directly plugged into the micro
USB port of the Sera
TM
.
•
It is advised not do any testing while device is in the cradle, as this may introduce artifacts to the test,
impacting the quality of the test result.
This equipment is intended to be connected to other equipment thus forming a
Medical Electrical System. External equipment intended for connection to signal
input, signal output or other connectors shall comply with the relevant product
standard e.g., IEC 60950-1 for IT equipment and the IEC 60601-series for medical
electrical equipment. In addition, all such combinations – Medical Electrical
Systems – shall comply with the safety requirements stated the general standard IEC 60601-1, edition 3,
clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e., at least 1.5 m from the patient support or shall be supplied via a
separation transformer to reduce the leakage currents. Any person who connects external equipment to
signal input, signal output or other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If in doubt, contact qualified medical technician
or your local representative. If the instrument is connected to a PC (IT equipment forming a system), ensure
not to touch the patient while operating the PC.
If the instrument is connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.
Note! The USB connection on the instrument has insulation protections to the patient connections.
The consequence of not following this precaution could be a too high leakage current to the patient.
IMPORTANT NOTE:
The internal battery should only be replaced by an authorized service representative.
Damage to the electronics resulting from an attempt to change the battery by someone other than an
authorized representative will not qualify for repair under the product warranty.
3.13 Battery lifetime and charging time
Please note:
Please observe the following precautions:
The battery can only be maintained by service personnel.
•
Keep the battery fully charged
•
Do not let the battery get fully depleted
•
Do not place the battery in a fire or apply heat to the battery
•
Do not damage the battery or use a damaged battery
•
Do not expose the battery to water
•
Do not short circuit the battery or reverse the polarity
•
The battery automatically starts charging when the Sera
TM
is placed properly into
the AC-powered cradle or when connected via USB to the PC
•
Use only the charger provided with the Sera
TM
•
The Sera
TM
will shut down automatically when the battery charge is too low to
support continued operation.