Bedienungsanleitung SunTech CT40 (Seite 5 von 52) (Englisch)

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80-0067-00-MO-RevJ 2019-01-30 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 (SpO2) 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.

The device is intended to be used in outpatient departments, emergency treatment rooms, low-acuity areas of

hospitals, community clinics, private clinics, and other medical institutions. It is not intended for helicopter transport,

hospital ambulance or home use. It is not intended for near active HF SURGICAL EQUIPMENT and the RF shielded

room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.

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,

SpO2 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.

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