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SunTech CT40 User Manual

SunTech CT40
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80-0067-00-MO-RevF 2017-10-03 SunTech CT40 User Manual | 1
Spot-check Vital Signs Device
User Manual

Table of Contents

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SunTech CT40 Specifications

General IconGeneral
TechnologyOscillometric
ConnectivityUSB
Parameters MeasuredSystolic BP, Diastolic BP
PowerAC adapter
Memory Capacity99 readings

Summary

SunTech CT40 Description and Operation

Safety Considerations

Intended Use

Defines the clinical grade, automated blood pressure measurement device with optional temperature and pulse oximetry modules.

Indications for Use

Specifies the device's capability to measure and display blood pressure, heart rate, SpO2, and body temperature for specific patient groups.

User Responsibility

Outlines the user's responsibility for proper assembly, operation, maintenance, and repair of the device.

Use of SunTech CT40

Provides guidelines on using specific cuffs, monitoring patients, and understanding factors affecting measurement accuracy.

Pulse Oximetry (SpO2) Safety

Specifies the use of approved SpO2 sensors and cables to ensure compatibility and prevent patient injury.

Warnings and Cautions

Lists critical safety warnings regarding IV lines, limb circulation, wounds, defibrillator protection, and flammables.

Icons, Symbols, and Abbreviations

Icons and Symbols Guide

Illustrates common icons and symbols used on the device and in the manual for various functions and warnings.

Commonly Used Abbreviations

Provides a list of common abbreviations used in the manual, such as BP, BPM, EMR, SYS, DIA, etc.

Setting Up the SunTech CT40

Unpacking the Monitor

Instructions for checking all proper components upon unpacking the SunTech CT40 device.

Rear Panel Configuration

Details the connections available on the rear panel of the SunTech CT40 device, including power and USB ports.

Side Panel Configuration

Explains how to attach side panels for temperature or SpO2 modules using a Phillips-head screwdriver.

Install Batteries

Guidance on installing the rechargeable lithium-ion battery, including charging time and precautions.

Battery Disposal

Instructions for environmentally responsible disposal of the device's lithium-ion battery.

Attach Connections to the Device

Steps for connecting power, BP cable, SpO2 sensor, temperature sensor, and other accessories.

Mounting Options

Information on using the device on a tabletop or mounting it to a wall or mobile stand.

System Configuration

Details on configuring the device using the Advanced Configuration Application for network or EMR connectivity.

Getting to Know the SunTech CT40

Measurement Display Overview

Explains the various elements and icons displayed on the SunTech CT40's measurement screen.

Patient Identification and Date/Time Stamp

Describes how patient ID and time stamps are displayed and managed on the device.

Memory Mode Information

Explains the memory icon and memory delete icon for managing saved measurements.

Connections to Ancillary Devices and Networks

Details icons indicating Wi-Fi, AC power, printer, and barcode scanner connectivity.

Error Alert Symbol

Indicates a warning symbol that prompts the user to take immediate action for errors.

Battery Level Indicator

Describes the battery symbol and its segments indicating the device's remaining battery power.

Blood Pressure Measurement Mode Selection Icons

Explains icons related to selecting measurement modes like Averaging and Auscultatory.

Blood Pressure Results (DIA and SYS)

Defines the display of Diastolic (DIA) and Systolic (SYS) blood pressure values.

EMR Transmission Icons

Illustrates icons indicating EMR connectivity status and successful data transmission.

Adult or Child Patient Selection

Details how to switch between Adult and Pediatric BP measurement modes.

Heart Rate and MAP Measurements

Explains how heart rate (BPM) and Mean Arterial Pressure (MAP) are displayed.

Pulse Oximetry Measurement Display

Describes the SpO2 display indicating arterial oxygen saturation percentage.

Temperature Measurement Settings and Results Display

Details icons for temperature units, modes (Cold, Predictive, Direct), and measurement sites.

Control Panel Overview

Control Panel Buttons

Describes the functions of the Memory, Toggle Mode, Selection Knob, Start/Stop, and Home buttons.

Monitor Setup Procedure

Guides through the initial power-up process, including setting the date and time.

Good to Know Before You Begin

Power Modes

Explains Initial Power-up, Nominal Power-up, Power-down, and Automatic Power-down modes.

Documenting Measurements

Details the importance of documenting patient ID, including using a barcode scanner.

Printing

Instructions on connecting and using the optional SunTech thermal printer for measurement results.

Saving Measurements

Describes how to save measurements to the device memory or send them to an EMR system.

Using SunTech CT40 for BP Measurement

Step 1: Preparing the Patient

Covers patient positioning and selecting and positioning the appropriate BP cuff.

Step 2: Select Between Adult Vs Pediatric Mode

Explains how to switch between Adult and Pediatric measurement modes for different patient age groups.

Step 3: Select Measurement Mode

Details the three BP measurement modes: Single, Averaged, and Auscultatory SphygMode.

Averaging Measurement Mode

Guides on setting the number of measurements to average and time intervals.

Auscultatory SphygMode

Instructions for setting up and using the Auscultatory SphygMode for manual BP verification.

Step 4: How to Measure BP in Each Mode

Provides step-by-step instructions for performing BP measurements in Single, Averaging, and Auscultatory modes.

Step 5: Record Results

Explains how to record, print, or digitally save the blood pressure and heart rate measurements.

Step 6: Prepare for New Patient

Details steps for clearing data and preparing the device for the next patient.

Heart Rate Measurement

BP Heart Rate Measurement

Describes how heart rate is captured automatically during BP measurement.

SpO2 Heart Rate Measurement

Explains measuring heart rate using the optional SpO2 sensor.

Pulse Oximetry

General Principle of Operation

Explains how pulse oximeters use light absorption to measure arterial oxygen saturation (SpO2).

CAUTION: Inaccurate measurements may be caused by:

Lists factors that can cause inaccurate SpO2 readings, such as sensor application and patient condition.

CAUTION: Pulse rate measurement...

Warns that pulse rate measurement is based on peripheral flow and may not detect certain arrhythmias.

CAUTION: SpO2 is empirically calibrated...

Explains SpO2 calibration and how COHb/MetHb levels affect accuracy.

System Description

Describes the CT40 device, SpO2 modules (Masimo SET, ChipOx), and reusable probes.

Taking SpO2 Measurements

Step-by-step instructions for correctly applying the SpO2 sensor and obtaining readings.

Special Notes for Masimo® SET SpO2 module

Notes on Masimo SET module, including patent information and sensor compatibility.

Additional Masimo® Information

Provides detailed information on the Masimo SET MS board pulse oximeter principles and DST plot.

Masimo® Graphical Plot

Presents a graphical plot of ARMS values for Masimo SET Oximetry accuracy.

Special Notes for ChipOx SpO2 module

Notes on ChipOx module, including sensor usage and compatibility verification.

Chipox Graphical Plot

Shows a graphical plot of ARMS values for ChipOx Oximetry accuracy.

Temperature Measurement

Covidien® FILAC® 3000 Thermometry Module

Describes the FILAC 3000 module for oral, axillary, or rectal temperature readings and probe cover usage.

Oral Temperature Taking

Instructions for performing oral temperature measurements using the thermometer probe.

Axillary Temperature Taking

Steps for conducting axillary temperature measurements under the arm.

Rectal Temperature Taking

Guidance for performing rectal temperature measurements with the thermometer probe.

Other FILAC® 3000 Temperature Settings

Details various modes (Quick, Predictive, Direct, Cold) of the FILAC 3000 thermometer.

Touchless Thermometry Module

Instructions for using the optional touchless infrared temporal thermometer.

EMR and Memory Functions

Memory Mode

Explains how to save, recall, and manage measurements using the device's memory function.

Clearing Measurements from Memory

Provides steps for clearing single or all measurements from the device memory.

EMR Transmissions

Details on sending measurements to an EMR system, including validation and transmission processes.

Validating Patient ID with EMR

Explains the process of scanning a patient's barcode ID to validate it with the EMR system.

Sending Measurements to EMR

Describes the procedure for sending measurements to an EMR, including troubleshooting error messages.

Taking Care of the SunTech CT40

Cleaning the Device

Instructions for cleaning the SunTech CT40 monitor using mild disinfectants.

SpO2 Sensors and Thermometers

Guidelines for cleaning and caring for SpO2 sensors and thermometer probes.

Preventative Maintenance

Covers system self-checks and inspection of replaceable parts like cuffs and hoses.

Replaceable Parts

Advises on inspecting and replacing monitor parts like cuffs and hoses for damage.

Replacing and Disposal of the Battery

Information on replacing the battery and the hazards associated with it.

Battery Disposal

Instructions for environmentally responsible disposal of the device's lithium-ion battery.

Product Disposal

Guidance on disposing of the product according to WEEE directive.

Cuff Disposal

Instructions for proper disposal of used blood pressure cuffs.

Routine Calibration

Recommends bi-annual checking of blood pressure function accuracy by a biomedical technician.

Accessories and Replacement Parts

Main Unit Accessories

Lists part numbers and descriptions for main unit accessories like BP hoses and cuffs.

SpO2 Modules

Details Masimo SET and ChipOx SpO2 modules, including reusable sensors and patient cables.

Temperature Modules

Lists Covidien FILAC 3000 and Touchless IR thermometer modules and related accessories.

Stands, Printers, and Scanners

Includes accessories like mobile stands, printer mounts, thermal printers, and barcode scanners.

Status Messages and Alarms

Status Messages

Explains how error codes are displayed and provides actions for BP, Temperature, SpO2, and EMR status messages.

Status Message Codes by Category

Lists specific status codes for Temperature, SpO2, EMR, CT40 System, Powering Device, and Barcode Scanner issues.

Out of Range Measurement Parameters

Specifies the normal measurement ranges for BP, Heart Rate, Temperature, and SpO2.

Frequently Asked Questions

What is the expected battery life for the SunTech CT40?

Details the battery life in measurement cycles and remaining power indicators.

Will the device automatically power down?

Explains the automatic power-down feature after a period of inactivity.

What is the significance of different beeps I hear during operation?

Describes the meaning of various beeps, including long beeps for measurement completion and short beeps for errors.

Technical Information

EMC Statement

Provides essential electromagnetic compatibility (EMC) information and precautions for installation and use.

Guidance and manufacturer's declaration - electromagnetic emissions

Details compliance with emissions standards and guidance for the electromagnetic environment.

Guidance and manufacturer's declaration - electromagnetic immunity

Outlines immunity test levels and guidance for the electromagnetic environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

Specifies immunity requirements for voltage variations on power supply lines.

Power frequency (50/60 Hz) magnetic field

Details immunity requirements for power frequency magnetic fields.

Conducted RF

Specifies immunity requirements for conducted radio frequency (RF) disturbances.

Radiated RF

Provides immunity requirements and recommended separation distances for radiated RF fields.

Recommended separation distances between portable and mobile RF communications equipment and the CT40

Calculates recommended separation distances based on transmitter output power to prevent RF interference.

Specifications, General

Lists general specifications including operating conditions, power, dimensions, standards, and classifications.

Specifications, Blood Pressure Measurement

Details specifications for BP measurement, including measurement method, range, and accuracy.

Notes on Blood Pressure Data

Discusses factors that can affect blood pressure readings, such as patient condition and environmental factors.

SPO2 Sensor Specifications

Provides technical specifications for ChipOx and Masimo SET SpO2 sensors, including accuracy and saturation ranges.

Temperature Sensor Specifications

Details specifications for Touchless IR and Covidien FILAC thermometers, including accuracy and response time.

Limited Warranty

Outlines the limited warranty provided by SunTech Medical, Inc. for the device and its components.

Conflict Minerals

Provides a link to SunTech's current Conflict Minerals Statement.