HS80G-L1 12 channel ECG device

Nom de l'organisation

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság

SRN

HU-MF-000017747

Statut du fabricant

Actif

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

• CW010

  Read the instructions for use carefully before using the device!
• CW138

  inserting the device into a measurement system, make sure that only properly isolated and IEC 60601 tested devices are connected and that patient should not touch any device connected to the mains. If the device is used connected to a computer, make sure that patient cannot get closer than 1.5m to the computer or it should be operated from an isolating transformer. The device’s defibrillator protection is only ensured with one of the following manufacturer specified defibrillator-protected cables. Cable type: KPACDF It is strictly FORBIDDEN to use high-frequency (HF) surgical devices with this device! The ECG evaluation program offers a recommended diagnosis, final decision is physician’s responsibility! Be sure any not connected electrode to patient should not be contact to any other conductive part including heart. The serious incident occurring during operation of the equipment shall be reported to the competent authority or to the manufacturer. A serious incident shall mean any incident which, indirectly or directly, has led, could have led or might led to the following cases: death of the patient, user or other individual; serious temporary or permanent damage to the health of the patient, user or other individual; serious public health risk.
• CW036

  Only the 10 pcs electrodes can be connected to the patient, application of separate grounding is FORBIDDEN!
• CW273

  HeartScreen80G-L1 is a safety class no. I. ECG device (with CF class patient protection). The power supply of the device can only be connected to grounded mains outlet. It is FORBIDDEN to cover the adapter of the charger!
• CW011

  Device cover can only be removed or fuse can only be changed after unplugging the device from the mains. Repairs can only be performed by qualified personnel.

Marché principal en Hongrie ; disponible dans 14 pays au total.

Dénomination commerciale

HS80G-L1 12 channel ECG device

Code d'UDI-DI

D-HS80G-L1BE

Basic UDI-DI

B-HS80G-L1BE

Numéro de référence/catalogue

KHS80GL1

Entité d'attribution

EUDAMED

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://www.innomed.hu/en/#contact

Dimensions cliniques

• 12 leads, simultaneous
• Under 0,3 Hz: full suppression; over 0,9 Hz: full transfer
• 1000 Hz / channel
• 24 bit
• 2100mAh Ni-MH
• min. 20 MOhm
• min. +/- 320 mV DC
• 1 mV / 300 ms
• 35 Hz +0/-3 dB
• 50 / 60 Hz
• 50 Hz filter: 48,5 … 51,5 Hz; 60 Hz filter: 59 … 61 Hz
• +/-1 BPM or +/-2%
• 50 / 60 Hz
• Mains voltage — 100–240 MU114
• Mains power consumption — 0.3–0.6 MU107
• +/-10 mVp
• Battery nominal voltage — 9.6 MU114
• Battery charging current (informative) — 1.3 MU107
• Heart frequency measurement - Range — 30–240 MU999
• 0,05 Hz…150 Hz +0, -3 dB
• 2, 5, 5, 10, 20 mm/mV
• max. 30 µVpp
• min. +/- 2 mV/0,5 ms; max. +/- 700mV/2ms
• min. 100 dB
• max. +/- 700mV/2ms
• max. 360 J, 5000 V
• max. 10 µA
• 2,5 µV/bit
• 500 Hz 10 µV/bit
• 500 Hz 10 µV/bit
• 40 mm, overlapping allowed
• 80 mm +0; -1 mm
• In amplitude direction: 8 points / mm; On the time axis: 8 or 16 points / mm
• 5, 25, 50 mm/s
• Max. paper speed (in case of 60 bpm, informative) — 2.5 MU11
• max. 50 mm
• Printer lifetime — 50000 MU36
• automatic threading
• 1+0.3 kg
• 240 x 320 points
• USB; virtual RS232
• 250 MU50
• 15 MU50
• 70 MU50

• Z12050302ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS

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