80-0067-00-MO-RevF 2017-10-03 SunTech CT40 User Manual | 5
1.
Safety Considerations
Intended Use
The SunTech CT40 is a clinical grade, automated blood pressure measurement device with optional
temperature and pulse oximetry modules for spot-check vital sign measurements in physician offices, long-
term care facilities, and low-acuity areas in hospitals. The CT40 can be used in combination with a clinical IT
network to transfer and store patient measurement data on an EMR system.
Indications for Use
The SunTech CT40 is a non-invasive oscillometric spot-check vital signs device. The CT40 is capable of measuring
and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO
2
) and
body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it
is necessary to take a single or a series of vital signs measurements on a patient. The CT40 is only for measurement,
recording and display. It makes no specific diagnoses.
The SunTech CT40 is intended to be used on adult and pediatric patients using appropriately-sized SunTech One-
piece Durable (OPD) BP cuffs.
User Responsibility
Your SunTech CT40 is designed to perform in conformity with the description thereof contained in this operation
manual and accompanying labels and inserts, when assembled, operated, maintained and repaired in accordance
with the instructions provided.
Further, the user of this device bears sole responsibility for any malfunction that results from improper use, faulty
maintenance, improper repair, damage or alteration by anyone other than SunTech Medical or authorized service
personnel.
Use of SunTech CT40
Use only One-piece Durable (OPD) BP cuffs supplied by SunTech Medical.
Observe the patient carefully during the measurement. Ensure pressure compatibility to all patients. If any
abnormality occurs, either in the unit or the patient, suspend the operation immediately and disconnect the BP cuff,
SpO
2
sensor and thermometer (if applicable) from the patient.
Accuracy of any BP reading or oxygen saturation measurement may be affected by the position of the patient, their
physical condition and use outside of the operating instructions detailed in this guide. The interpretation of BP and
oxygen saturation measurements should only be made by a physician.
Safety and effectiveness when used with pregnant women, children under 3 years of age and neonates have not been
established.
Pulse Oximetry (SpO
2
)
ChipOx SpO
2
Module: Use only pulse oximeter (SpO
2
) sensors supplied by SunTech Medical or original Nellcor
®
pulse
oximeter (SpO
2
) sensors supplied by Covidien
®
(except for forehead reflectance sensors).
Masimo
®
SpO
2
Module: Use only original Masimo
®
pulse oximeter (SpO
2
) sensors and cables.
