2092504-270

Organization name

GETEMED Medizin- und Informationstechnik AG

SRN

DE-MF-000012384

Manufacturer status

Active

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• CW999

  WARNING: GENERAL RISK TO PATIENT HEALTH AND LIFE - The life or health of a patient may be put at risk if the medical personnel do not have all the information contained in the operator manual. Carefully read the operator manual. It contains important in-formation for a correct ECG analysis. WARNING: MIXING UP RECORDINGS - The life or health of a patient may be put at risk if a different patient's examination is assigned to this patient, thus resulting in an incorrect diagnosis. Take special care to always select the correct examination and correct patient in the software. To ensure that a recording is not assigned to the wrong patient, always enter the pa-tient's ID into the recording medium or write the patient's ID on the medium before starting the recording. WARNING: USING THE RESULTS OF THE AUTOMATIC ANALYSIS FOR DIAG-NOSIS - Using the results of the automatic analysis for diagno-sis without first validating them may put the patient's life or health at risk. The ECG morphology classification and events resulting from the automatic analysis of the ECG data by CardioDay must not be used for diagnostic purposes before they have been validated by a trained physician or healthcare professional experienced in Holter ECG analysis. In addition, it is extremely important that you view and validate the raw ECG data (Full disclosure tab) and that you do not rely solely on the analysis results generated by the software itself. For example, strong interference fields, movement artifacts, or loose electrodes may influence the signal morphology and produce classes or events that are not consistent with the patient’s actual heart condition.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04250903202520

Basic UDI-DI

0425090320240N2

Reference / catalog number

2092504-270

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric human patients. CardioDay provides the user arrhythmia study and Holter analysis capabilities.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

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• Z12050492HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE

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