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Welch Allyn Connex ECG Module, Инструкция по применению

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Contraindications

The Welch Allyn ECG/Impedance Respiration module is not intended for infants

weighing less than 10 Kg (22 lbs) or neonatal patients.

This module is not designed for direct cardiac application.

This module is not suitable for transport.

Computer-assisted ECG data acquisition and interpretation is a valuable tool when used

properly. However, no automated interpretation is completely reliable. Interpretations

should be reviewed by a qualified physician before treatment, or non-treatment, of any

patient.

2  Introduction

Welch Allyn Connex

®

 Devices ECG Module

Содержание Connex ECG Module

Страница 1: ...Welch Allyn Connex Devices ECG Module Directions for use For use with compatible Connex devices running software version 2 3X or higher...

Страница 2: ...oftware may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and o...

Страница 3: ...d connect the ECG module 16 Alarms 17 Physiological alarm summary 17 ECG acquisition 19 Lead placement overview 19 Attach the leads to the patient 22 Maintenance 25 Clean the equipment 25 Inspect the...

Страница 4: ...iv Contents Welch Allyn Connex Devices ECG Module...

Страница 5: ...restricts this device to sale distribution or use by or on the order of a physician or licensed healthcare professional The ECG Impedance Respiration module is intended for continuous measurement of...

Страница 6: ...ect cardiac application This module is not suitable for transport Computer assisted ECG data acquisition and interpretation is a valuable tool when used properly However no automated interpretation is...

Страница 7: ...her property or loss of data This definition applies to both yellow and black and white symbols Follow the operating instructions directions for use DFU mandatory action A copy of the DFU is available...

Страница 8: ...ngs for control of pollution caused by electronic information products XX indicates Environmentally Friendly Use Period in years Reorder number Serial number Defibrillation proof Type CF applied parts...

Страница 9: ...rate and Impedance respiration ECG frame and lead selector Heart rate Pulse rate Beats per minute to represent heart rate pulse rate Saved waveform icon Review tab Saved waveform icon alarm condition...

Страница 10: ...6 Screen elements Welch Allyn Connex Devices ECG Module...

Страница 11: ...ons WARNING Many environmental variables including patient physiology and clinical application can affect the accuracy and performance of the Connex device and ECG module Therefore you must verify all...

Страница 12: ...properly if dropped or damaged Protect it from severe impact and shock Do not use the ECG module if you notice any signs of damage Qualified service personnel must check any ECG module that is dropped...

Страница 13: ...Federal law restricts this equipment to sale distribution or use by or on the order of a physician or licensed healthcare professional CAUTION Electromagnetic interference risk The equipment complies...

Страница 14: ...e not true to scale Make manual measurements of ECG intervals and magnitudes on printed ECG reports only WARNING The arrhythmia analysis program is intended to detect V Tach V Fib and asystole It is n...

Страница 15: ...rate and failure to detect cardiac arrest and some life threatening arrhythmias V Tach V Fib and asystole If your patient has a pacemaker turn pacemaker detection ON to avoid this hazard WARNING Inacc...

Страница 16: ...n negate defibrillator protection and can create a risk of patient injury due to shock WARNING To avoid serious injury or death take precautions consistent with good clinical practice during patient d...

Страница 17: ...de placement is employed for the lead configuration selected WARNING The ECG module should not be used on patients who are linked to heart lung machines WARNING If an electrosurgical unit is used plac...

Страница 18: ...o ensure professional installation safety and reliability of any mounting accessory CAUTION Position the wall mount so that the screen controls and connectors are accessible and support optimal and er...

Страница 19: ...p to facilitate mounting the module and a USB cable to connect to the host device No Feature Description 1 USB cable Connects module to the Connex Vital Signs Monitor provides power to the ECG module...

Страница 20: ...ion CAUTION Connect the USB cable to the Connex device in a manner that minimizes entangling CAUTION To prevent accidental loosening of the USB cable and the potential loss of ECG connection to the de...

Страница 21: ...scriptions of alarm behavior controls and messages Physiological alarm summary Alarm condition Alarm threshold Asystole No detectable beat for 4 seconds Ventricular tachycardia Default 120 bpm 3 bpm f...

Страница 22: ...18 Alarms Welch Allyn Connex Devices ECG Module...

Страница 23: ...e that the electrosurgical return conductor neutral is properly attached to the patient and makes a good contact Proper lead placement is important for a successful ECG The most common ECG problems ar...

Страница 24: ...Lead placement 3 lead IEC R Red L Yellow F Green AHA RA White LA Black LL Red Lead placement 5 lead IEC N Black R Red L Yellow C White F Green 20 ECG acquisition Welch Allyn Connex Devices ECG Module...

Страница 25: ...tandard ECG electrode placement In these cases change the LL and RA electrode placement to the mid axillary line on each side of the chest as shown in the illustrations Note Respiration can only be ac...

Страница 26: ...ries approved by Welch Allyn including electrodes lead wires and patient cables These approved accessories are required for electrical protection of the patient during cardiac defibrillation Refer to...

Страница 27: ...ctrode 4 Apply the electrodes disposable or reusable to the patient according to the Lead placement overview presented earlier in this section For reusable electrodes Use electrode paste gel or cream...

Страница 28: ...Over longer periods the electrode gel can dry out and the patient s skin can be irritated by the gel or adhesive When replacing the electrodes do not position the new electrodes on exactly the same lo...

Страница 29: ...ning wipes or solutions Clorox HP Hydrogen Peroxide Cleaner Disinfectant Wipes Clorox Healthcare Dispatch Hospital Cleaner Disinfectant Towels with Bleach Clorox Healthcare CleanCide Wipes Wexford Lab...

Страница 30: ...that are identified in the product specifications Discard the equipment Discard the ECG module cables and accessories according to local laws Do not dispose of this product as unsorted municipal wast...

Страница 31: ...arby equipment and devices It is not normally affected by nearby equipment and devices It is not safe to operate the monitor in the presence of high frequency surgical equipment However it is good pra...

Страница 32: ...28 EMC guidance and manufacturer s declarations Welch Allyn Connex Devices ECG Module...

Страница 33: ...on against liquid ingress Device classification EMC Class Class IIB IEC Type Type CF Environmental specifications Characteristic Specification Operating temperature 50 F to 104 F 10 to 40 C Storage te...

Страница 34: ...er to change in heart rate Increasing from 80 to 120 beats minute 10 sec Decreasing from 80 to 40 beats minute 10 sec Time to alarm for tachycardia Waveform B1 Amplitude Average time to alarm 0 5 mV 1...

Страница 35: ...n Connector at ECG module 80 in 1 shielded cable to a 24 in 1 lead fan out to electrode connection ECG cables 3 lead or 5 lead to snap connection Patient cables Conforms to ANSI AAMI EC53 Impedance re...

Страница 36: ...f consecutively detected beats 10 Heart rate 60 average of last 10 detected consecutive R R intervals 2 and 10 Heart rate 60 average of the detected consecutive R R intervals Response to change in Hea...

Страница 37: ...t heart rate Device classification ECG device will operate per table below after startup and after changes to parameter configurations e g filter on off or lead off recovery Parameter Initial report a...

Страница 38: ...omplies with the following standards1 IEC 60601 1 IEC 60601 1 2 IEC 60601 1 6 IEC 60601 2 272 ISO 10993 IEC 62304 IEC 62366 1 Standard is essentially the IEC 60601 1 General standard plus the listed c...

Страница 39: ...CBL5A Patient cable 5L AHA 6000 ECG3I Module USB Patient cable 3L IEC 6000 ECG3A Module USB Patient cable 3L AHA 6000 ECG5I Module USB Patient cable 5L IEC 6000 ECG5A Module USB Patient cable 5L AHA 1...

Страница 40: ...accidents If a product or accessory covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty p...

Страница 41: ......

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