Testing patient monitors according to IEC 62353

VITAL SIGNS SIMULATION FOR FUNCTIONAL TESTING OF ECG RECORDERS AND PATIENT MONITORS

PATIENT MONITORING SYSTEMS - VITAL SIGNS MONITORING

In clinics, there is a need for seamless recording of high-resolution medical data (vital signs: e.g. heart rate, blood pres-sure and primary signals: e.g. ECG) from surveillance monitors. This enables a quick overview of the patient's current status, taking the history into account. By recording over a longer period of time, individual events can be analyzed more precisely in retrospect. This data is used for current patient monitoring (e.g. in intensive care medicine), for patient documentation and for data analysis in the field of medical research.

A patient monitor is a medical device used to monitor important physiological parameters of a patient during medical examinations, operations or in medical facilities. The main function of a patient monitor is to record information about a patient´s state of health continuously and accurately and pass it on to medical staff.

A typical patient monitor measures and monitors several parameters, including

Heart rate: The monitor displays the patient's heart rate in beats per minute. This information is important for monitoring the heart rhythm and detecting changes or deviations.

Blood pressure: The monitor measures the patient's systolic and diastolic blood pressure. This enables medical staff to read the blood pressure curve and react to possible problems such as hypertension (high blood pressure) or hypotension (low blood pressure).

Oxygen saturation: Oxygen saturation in the blood, also known as SpO2, is measured using a sensor placed over the patient's finger or ear. A low oxygen level can indicate breathing problems or an insufficient oxygen supply.

Respiratory rate: The patient monitor counts the patient's breaths per minute. This helps to detect changes in bre-athing, especially rapid or shallow breathing, which may indicate respiratory disorders or complaints.

ECG: An ECG (electrocardiogram) measures the electrical activity of the heart and indicates any existing cardiac arrhyth-mia. The monitor displays the ECG graphic pattern and thus enables the cardiac function to be assessed.

 

Use of a patient monitor in the OR

 

MONITORING THE PATIENT

In addition to these basic parameters, patient monitors can also monitor other measurements such as body temperature, respiratory carbon dioxide levels, invasive blood pressure (via arterial catheterization), brain pressure (intracranial pressure) and other specific values that vary according to the patient's needs and the requirements of the medical facility.

The patient monitor displays the measured data in real time on a screen that is clearly visible to medical staff. Audible and visual alarms can also be set to alert staff to critical or out-of-range values. This enables early detection of complications or changes in the patient's state of health, supporting appropriate treatment and monitoring.

Electrocardiogram (ECG)

ECG

The electrocardiogram (ECG) (from the ancient Greek καρδία kardía, meaning 'heart', and γράμμα grámma, meaning 'written') is the recording of the sum of the electrical activity of all heart muscle fibers using an electrocardiograph (also known as an ECG device). The recording process is called electrocardiography. The electrocardiogram is also known in German as cardiac current and cardiac voltage curve, and is sometimes also called heart writing.

Every contraction of the heart muscle is preceded by an electrical excitation, which normally originates from the sinus node. It travels to the other heart muscle cells via the heart's own electrical conduction system of specialized heart muscle cells. These electrical voltage changes in the heart can be measured on the surface of the body and recorded over time. The result is a recurring image of the heart's electrical action. The ECG can be used to make a variety of statements about the characteristics and health of the heart. It should be noted that the surface ECG only shows the electrical activity of the heart muscle, but does not reflect the actual ejection capacity. In most cases, the ECG is evaluated by increasingly reliable computer programs, but this does not make the assessment of the recording on paper or on the screen by the doctor unnecessary.¹

STANDARDS

DIN EN 60601-2-27 is part of the DIN EN 60601 series of standards and deals with specific requirements for the safety and performance of electromyographic devices (EMG). It comprises various sections:

• Scope of application and normative references
• Normative specifications
• General requirements for the safety of EMG devices
• Specific requirements for the safety of EMG devices
• Tests
• Labeling and instructions

DIN EN 60601-2-34 contains particular specifications, including the relevant performance characteristics, for the safety of invasive blood pressure monitoring devices. These include requirements for accuracy, as invasive blood pressure monitors are used in areas where a high degree of accuracy is required. This normally involves vascular access to the patient's blood.

For pulse oximeters, DIN EN ISO 9919 contains special specifications for the safety and essential performance characteristics of pulse oximeters for medical use. According to standard, the accuracy of a pulse oximeter should have an RMS difference (root mean square deviation) of less than or equal to 4.0% SpO2 over the range from 70% to 100% SaO2.

DIN EN 60601-2-25:2016 IEC 60601-2-25:2011	Medical electrical equipment – Part 2-25: Particular requirements for the safety, including essential performance, of electrocardiographs
DIN EN 60601-2-27:2015 IEC 60601-2-25:2011	Medical electrical equipment – Part 2-27: Particular requirements for the safety including essential performance of electrocardiographic monitoring equipment
DIN EN 80601-2-30:2020 DIN EN 80601-2-30:2016 IEC 80601-2-30:2009 / AMD1:2013 IEC 80601-2-30:2018	Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automated non-invasive blood pressure monitors
DIN EN 60601-2-34:2015 IEC 60601-2-34:2011	Medizinische elektrische Geräte – Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von invasiven BlutdruckÜberwachungsgeräten
DIN EN IEC 80601-2-49:2020 IEC 80601-2-49:2018 DIN EN 60601-2-49:2016 IEC 60601-2-49:2011	Medical electrical equipment - Part 2-49: Particular requirements for the safety, including essential performance, of multifunctional patient monitoring equipment
DIN EN ISO 80601-2-55:2019 ISO 80601-2-55:2018	Medical electrical equipment - Part 2-55: Particular requirements for the safety, including essential performance, of monitoring devices for breathing gases
DIN EN ISO 80601-2-56:2020 ISO80601-2-56:2017/AMD1:2018	Medical electrical equipment - Part 2-56: Particular requirements for the safety including essential performance of medical thermometers for measuring body temperature
DIN EN ISO 80601-2-61:2019 ISO 80601-2-61:2017	Medical electrical equipment - Part 2-61: Particular requirements for the safety including essential performance of pulse oximetry equipment

 

Patient Simulator	NIBP Tester	SpO2 Tester	NIBP Tester	Patient Simulator
Seculife PS100 / 200 / 300	Seculife BP PRO	SECULIFE SP BASE	Rigel UNI-Sim	Rigel PAT-Sim 200 / 400

 

¹ Wikipedia

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