User's Manual Part 1

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Precautions Prior to Using VS-XHR Heart Rate
Sensor
Read before administering VS-XHR Heart Rate Sensor!
Description
VS-XHR is a cardiac monitor sensor, used to detect, measure, and
transmit Heart Rate and Respiration Rate values to the VitalSense
Integrated Physiological Monitoring System (VS-IPMS). VS-XHR
attaches directly to the chest surface using standard disposable ECG
(EKG) electrodes. VS-XHR is powered from its own internal rechargeable
lithium coin cell; there is no external power source. There are no ECG
leads. VS-XHR is not equipped with any alarm function.
Intended Use
VS-XHR Sensor is intended to be used as an HR and/or RR monitor, in
conjunction with the VS-IPMS. VS-XHR is not equipped with alarms to
signal tachycardia or any other cardiac arrhythmias.
Indications
An indication is a sign or circumstance that indicates proper treatment.
• VS-XHR Sensor is an ambulatory, wireless, chest-worn, dermally
affixed, Heart Rate and Respiration Rate Sensor.
• The VS-XHR Sensor is to be used for monitoring vital signs (heart rate
and respiration rate) as part of a complete physiological sensor and
monitoring system.
• The subject is not restricted to a medical environment. The subject may
participate in normal activities while the VS-XHR Sensor is in place.
• The VS-XHR Sensor is a multi-use sensor.
• VS-XHR, in combination with VitalSense Physiological Monitoring
System, may be used where quantifiable measurement of human Heart
Rate and/or Respiration Rate are needed.