ReSTA

Organization name

GETEMED Medizin- und Informationstechnik AG

SRN

DE-MF-000012384

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW999

  The ReSTA software must not be used in connection with devices other than specified in this manual.
• CW999

  ReSTA is not intended to be used as a critical care monitoring system and it is not intended for direct monitoring of physiological processes.
• CW999

  Do not change other configurations than mentioned in this manual. Otherwise, the correct function of ReSTA cannot be assured.
• CW011

  The ReSTA system and client workstations should be protected against viruses and malware. A virus scanner should be installed on each server and workstation. Updates should be carried out on a regular basis. Automatic Updates should be switched off on Windows servers and the installed software to avoid unintended system reboots. Updates should be installed during routine maintenance windows instead. The ReSTA software must only be used combined with third-party software after prior approval by the manufacturer. If other than the approved software is used, a correct functioning of the system can no longer be guaranteed. For a potential internet failure a backup internet connection should be established. Otherwise, system failure and data loss could occur.
• CW999

  The RESTA software is not a monitoring system for emergency situations and it is not indicated for patients whose clinical condition requires continuous monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient.

Primary placement in Germany; available across 2 countries total.

Trade name

ReSTA

UDI-DI code

04250903202575

Basic UDI-DI

0425090320269NS

Reference / catalog number

75313011

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The ReSTA software is intended to support remote patient monitoring by receiving, storing, forwarding and visualizing externally acquired electrocardiogram (ECG) data. The ReSTA software is intended to support the physician in the interpretation of the ECG data. The ReSTA software is intended to be used for patients who could benefit from remote ECG monitoring.The ReSTA software has no patient related limitations, such as age, gender, skin pigmentation, etc. However, devices used to acquire the raw data may have. Therefore, it is the responsibility of the medical professional prescribing the devices to check the intended uses of such devices. The ReSTA software does not have direct contact with the patients. The ReSTA software is intended to be used by medical professionals. The ReSTA software operates on a server running a Microsoft Windows operating system. The ReSTA software is used to create a report for review and validation by a medical professional. The ReSTA software does not make any direct diagnostic or therapeutic decisions. The ReSTA software is not intended to be used as a critical care monitoring system and should not be used in emergency situations.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12050492HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE

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