PhysioMem PM 100 4G

Nom de l'organisation

GETEMED Medizin- und Informationstechnik AG

SRN

DE-MF-000012384

Statut du fabricant

Actif

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  WARNING MIXING UP RECORDINGS The patient’s life or health may be put at risk if the pa-tient is assigned a different patient’s ECG recording thus resulting in an incorrectly assigned diagnosis. Take special care to always select the correct examina-tion and the correct patient. Before the device is given to another patient, check that there are no more recordings stored on the device. WARNING STRANGULATION BY THE NECK LANYARD Neck lanyards present a possible strangulation risk. Do not wear the device with the neck lanyard around your neck while you are sleeping. WARNING RISK OF CONTAMINATION OR INFECTION Device and accessories may be contaminated with bacte-ria or viruses after use. If any contamination of the device or accessories has oc-curred, observe the standard procedures for handling contaminated objects and the following precautions: • Use protective gloves to handle the equipment. • Isolate the material by using suitable packaging and labeling. • Contact the addressee before sending the equipment. • Clean the device and accessories after every use. WARNING NOT A MONITORING DEVICE The PhysioMem PM 100 4G is not a monitoring device and is not intended for monitoring the clinical condition of a patient. Do NOT use the PhysioMem PM 100 4G as a monitoring device. WARNING EXPLOSION HAZARD Electrical sparks can cause explosions in the presence of certain gases. Do not use device in an oxygen-enriched environment or around other flammable or explosive gases. Establish whether the patient is liable to be in such an environment, possibly for job-related reasons.
• CW999

  CAUTION ELECTROMAGNETIC EMISSIONS While acquiring data do not use mobile phones or other electrical equipment such as computers or electrical tools close to the device. That may cause interference. CAUTION ELECTROMAGNETIC EMISSIONS Switch off the device in locations where the use of mobile network devices is totally or at times forbidden (e.g., in-tensive care unit, airplane). CAUTION HUMID ENVIRONMENTS The temperature of the device must not go below 5 °C or above 45 °C. Do not expose the device to sudden temper-ature or humidity changes. Quick changes in tempera-ture or humidity can cause condensation. Do not bring the device into the proximity of heat sources, such as heaters and ovens, and do not expose it to direct sun-light. CAUTION DAMAGE OF DEVICE AND ACCESSORIES Protect the device against mechanical damage by shocks, pressure and scratches. Otherwise, the correct functioning of the device can no longer be guaranteed. CAUTION DAMAGE OF DEVICE AND ACCESSORIES Do not use the device in the event of the packaging being damaged, unintentionally opened before use or if the packaging is exposed to environmental conditions outside of those specified in this manual. Otherwise, the correct functioning of the device can no longer be guaranteed. CAUTION MALFUNCTION Do not use the device if it has been damaged or has mal-functions. CAUTION UNAUTHORIZED ACCESS In order to avoid a wrong assigning of ECG data, keep the device protected against unauthorized access by third persons. CAUTION CONDUCTIVITY When wearing the device, ensure that the electrodes do not contact other conductive parts including earth. CAUTION PROPER MAINTENANCE Proper maintenance is vital for long-term safety and re-liability of the device. Each time before giving the device to a patient, visually check the device for damage.
• CW999

  WARNING MALFUNCTION OF PACEMAKERS AND ICD The device has an integrated mobile transmission mod-ule. Active mobile transmission devices in the close vi-cinity of pacemakers and implantable cardioverters/de-fibrillators (ICD) can cause malfunctioning of these de-vices. Do not place the device in the breast pocket of your shirt. Keep it at least 15 cm away from your implanted device after the recording. Patients with pacemakers or ICDs must not use the supplied neck lanyard to carry the device. WARNING EXTREME TEMPERATURES The device performance may be compromised at ex-treme temperatures. If the device has been stored at a temperature close to the extreme hot or cold limit, wait at least 4 hours for the device to reach ambient temperature before use. WARNING HOUSEHOLD PETS AND VERMIN Household pets and vermin may pose a risk to patient safety. Protect the device and accessories against contact with household pets, pests and children, as they could cause safety related damage to it, e.g., by biting it, letting it drop, exposing it to fluids or dirt.
• CW999

  Contraindications: The device 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.
• CW999

  CAUTION SERVICE AND REPAIR Repairs must be carried out only by persons authorized by the manufacturer. If you find or even suspect a mal-function, send the device for testing to the manufacturer or a facility authorized by the manufacturer. Please add a detailed description of the observed malfunction. CAUTION APPROVED ACCESSORIES Safe and reliable operation of the device is only possible when using the supplied and approved accessories. CAUTION INFECTION RISK Returning parts and products that have not been disin-fected exposes our service personnel to a risk of infec-tion. For hygienic reasons, and especially to help protect our service personnel, please disinfect the device before returning them to us for inspection or maintenance. CAUTION ACCIDENTAL ACTIVATION If the device is not in use, switch it off and store it with care to prevent accidental activation. This could result in incorrect ECG interpretation. Also, switch off the device before shipping to prevent inadvertent data transmission.

Marché principal en Allemagne ; disponible dans 8 pays au total.

Dénomination commerciale

PhysioMem PM 100 4G

Code d'UDI-DI

04250903202513

Basic UDI-DI

0425090320243N8

Numéro de référence/catalogue

77214001

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The PM 100 device is a two-channel cardiac event recorder for transmitting multiple event recordings via cellular telephony networks to a compatible receiving system, such as ReSTA from GETEMED. The device is intended for patient activated recordings. The PM 100 is intended to be used in both home environments and clinical environments. Home environments include ur-ban/suburban/ rural, school/office/retail environments, and vehicles like trains and cars. Airplanes are excluded as long as the use of cellular radio equipment is not allowed during flight. The device is battery-driven and utilizes a FLASH memory to store ECG data. The PM 100 is not intended to be used as a critical care monitoring system and should not be used in emergency situations. The PM 100 is indicated for the diagnostic evaluation of adult and pediatric (over 10 kg body weight) patients with asymptomatic and symptomatic disturbances of the cardiac rhythm and for the evaluation of recurrent unexplained episodes of racing heart, syncope, palpitations or dizziness. Patients with an age of less than 14 years need support from adults.

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• Z12050499HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS – OTHER

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