AS 60601.2.20:2018 Medical electrical equipment
The instructions for use shall contain the following additional items:
* a) A statement that a INFANT TRANSPORT INCUBATOR should be used only by appropriately trained personnel and under the direction of qualified medical personnel familiar with currently known RISKS and benefits of INFANT TRANSPORT INCUBATOR use.
* b) A warning that direct sunlight or other radiant heat sources can cause an increase in TRANSPORT INCUBATOR TEMPERATURE to dangerous levels.
* c) A statement that the use of oxygen increases the danger of fire and that auxiliary equipment producing sparks shall not be placed in the INFANT TRANSPORT INCUBATOR .
* d) A warning that even small quantities of flammable agents, such as ether and alcohol,left in the INFANT TRANSPORT INCUBATOR can cause fire in connection with oxygen.
e) A warning against possible use of the SKIN TEMPERATURE SENSOR as a rectal temperature sensor, if such a warning is applicable.
f) A statement of the maximum loads which can be applied to all supports and mounting brackets for ACCESSORIES and ancillary equipment.
g) For TYPE B APPLIED PARTS , where the INFANT may not be isolated from earth, a warning that particular care must be taken to ensure that additional ME EQUIPMENT connected to the INFANT is electrically safe.
h) An information on how and when to verify the functionality of the ALARM SYSTEM .
i) For oxygen administration into the COMPARTMENT :
– a warning stating that administration of oxygen may increase the noise level for the INFANT within the INFANT TRANSPORT INCUBATOR ;
– an explanation of the operation of supplementary oxygen equipment supplied for use with the INFANT TRANSPORT INCUBATOR or as specified in the ACCOMPANYING DOCUMENTS ;
– a statement that an oxygen analyzer shall be used when oxygen is delivered to the INFANT .
j) Details of any specified combinations of ME EQUIPMENT (see 201 .4.1 ).
*k) A statement that the INFANT TRANSPORT INCUBATOR cannot differentiate between an increase in core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE (hypothermia), and a recommendation to monitor the temperature of the
PATIENT.