cos30004-01va02

Nom de l'organisation

h/p/cosmos sports & medical gmbh

SRN

DE-MF-000006147

Statut du fabricant

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• CW273

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  Contraindications Absolute contraindications (have to be excluded before the treadmill is used) • Acute myocardial infarction (within 2 days) • Instable angina pectoris • Cardiac arrhythmia pathology and/or limited hemodynamics • Symptomatic massive aortic stenosis • Uncompensated / uncontrolled heart insufficiency • Acute pulmonary embolism or pulmonary infarction • Acute endocarditis, myocarditis, pericarditis • Acute aortic dissection • Acute coronary syndrome • Acute phlebothrombosis of the lower extremities • Febrile infections • Pregnancy • Acute thrombosis • Fresh wounds e.g. after surgery • Acute fracture • Damaged disc or traumatic disease of the spine • Epilepsy • Inflammations • Acute migraine • uncontrolled heart failure • dissecting aneurysm • recent aortic surgery and ECG abnormalities, such as abnormal ST-segment response (horizontal, planar or downslopingdepression of >1 mm, T-wave elevation of > 1 mm in leads without Q-waves, and Twavechanges such as inversion and pseudo-normalization when an inverted T-wave becomes upright. Relative contraindications (The application may be started if the possible benefits exceed the risks. The decision has to be made by the medical doctor before the treadmill is used) • Left main coronary stenosis • Main artery disease • Cardiac valve disease of moderate severity • Known electrolyte imbalance • Arterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.) • Tachyarrhythmia or bradyarrhythmia • Hypertrophic cardiomyopathy and other forms of outflow tract obstruction • Higher degree atrioventricular AV-blocking • Anemia • Physical and/or mental disabilities leading to inability to exercise adequately • Partially invasive medical devices (probes, infusions, catheters, external fixators, etc.)

Marché principal en Allemagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

40505880030812

Basic UDI-DI

4050588cos30003-015X

Numéro de référence/catalogue

cos30004-01va02

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

h/p/cosmos medical treadmills are intended for walking or running in place for - Recreational fitness training (incl. athletes) - Gait training (with or without body weight support) h/p/cosmos medical treadmills can be used in combination with external devices for walking or running in place as - Stressing devices for neuromuscular and biomechanical measurements (e.g. EEG, EMG, motion analysis) - Stressing devices for cardiovascular measurements (e.g. ECG) - Stressing devices for cardiopulmonary measurements (e.g. ergospirometry) Prescribed fall prevention device for any application where falling might cause an unacceptable risk (osteoporosis, high speed or special applications, applications with subjects not able to jump off the running belt such as children, physically impaired, etc.). product family: treadmill h/p/cosmos 170-190/65 MCU6 (quasar, pulsar)

URL des informations complémentaires

https://www.hpcosmos.com/sites/default/files/uploads/documents/20210922_hpcosmos_treadmill_manual_ifu_170-190_65_mcu6_sport-med_en.pdf

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel