Welch Allyn EarlySense System 1.0 - Equivalent to model EverOn 1.0 - User Manual - Manual (Page 12)

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Mode 2: The unit is internally powered, continuously powered, ordinary portable
equipment with applied part (IPX4).
Only equipment specified in this manual and complying with requirements of EN60601
should be connected to the system
The system complies with IEC 60601-1, IEC 60601-1-2 and IEC60601-1-4 EMC class A
device.
Intended Use
The EarlySense system is intended for continuous measurement of respiration rate, heart
rate and movement, in an automatic contact-less manner, at home, hospital or clinic
setting. The system is indicated for use in children, adolescents and adults. The operation
of the EarlySense System has been studied in children (weight ≥ 10 Kg) and adults
(weight ≤111 Kg) during sleep and resting condition.
Note
Definition of Age for Children: Children aged 2 and above
Contraindications for Use
The EarlySense System is contraindicated for use in:
• Patients in whom proper positioning cannot be achieved or maintained.
• Patients who do not meet the weight limits tested or specified.
• Situations where a dry environment cannot be ensured.
• An MR environment
• An explosive atmosphere or in the presence of flammable anesthetics or gases
Warnings and Cautions
• The EarlySense System should be installed and serviced only by qualified service
personnel, authorized by EarlySense Ltd.
• Mounting bed-side unit to the wall should be performed while exercising out-
most caution. DO NOT place the bed-side unit over patient’s head, to avoid
safety related conditions.