Welch Allyn Connex VSM 6000 series - Indications for Use

Note Some product features described in this publication might not be available
in your country. For the latest information about products and features,
please call Welch Allyn Customer Care.
Indications for use
The Connex VSM 6000 series of monitors is intended to be used by clinicians and
medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for
• noninvasive blood pressure (NIBP)
• pulse rate (PR)
• noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2)
• body temperature in normal and axillary modes
The most likely locations for patients to be monitored are general medical and surgical
floors, general hospital, and alternate care environments. Monitoring can be
accomplished on the VSM 6000 series bedside monitor itself, and the VSM 6000 series
bedside monitor also can transmit data continuously for secondary remote viewing and
alarming (e.g., at a central station). Secondary remote viewing and alarming features are
intended to supplement and not replace any patient bedside monitoring procedures.
The optional Masimo rainbow
®
SET Pulse CO-Oximeter
™
and accessories are indicated
for the continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate (PR), total hemoglobin concentration (SpHb
®
), and/or
respiration rate (RRa
™
). The Masimo rainbow SET Radical-7R
™
Pulse CO-Oximeter and
accessories are indicated for use with adult, pediatric, and neonatal patients during both
motion and no-motion conditions, and for patients who are well or poorly perfused in
hospitals and hospital-type facilities.
The optional Oridion
®
module and accessories are intended for the continuous
noninvasive measurement and monitoring of carbon dioxide concentration of the expired
and inspired breath (etCO2 and FiCO2) and respiration rate (RR). It is intended for use
with neonatal, pediatric, and adult patients in hospitals and hospital-type facilities.
The optional Oridion module also provides the clinician with an Integrated Pulmonary
Index
™
(IPI). The IPI is based on four parameters provided by the monitor: end-tidal
carbon dioxide (etCO2), respiration rate (RR), oxygen saturation (SpO2), and pulse rate
(PR). The IPI is a single index of an adult or pediatric patient's ventilatory status displayed
on a scale of 1–10, where 10 indicates optimal pulmonary status. IPI monitoring displays
a single value that represents the patient's pulmonary parameters and alerts clinicians to
changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital signs monitoring.
Optional compatible weight scales (e.g., Health o meter
®
) can be used for height,
weight, and BMI input.
The optional EarlySense
®
(Everon) System is intended for continuous measurement of
respiration rate, heart rate, and movement in an automatic contact-less manner, in a
hospital or clinic setting. The system is indicated for use in children, adolescents, and
adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg)
and adults (weight <111 Kg) during sleep and resting condition.
This product is available for sale only upon the order of a physician or licensed healthcare
professional.
2
Introduction Welch Allyn Connex
®
Devices