Nom de l'organisation

Integra LifeSciences (Ireland) Limited

SRN

IE-MF-000003849

Statut du fabricant

Actif

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

• Temperature measurements may be inaccurate if the connector of the temperature sensing probe is subjected to considerable changes in ambient temperature or if the ambient temperature of the Integra Licox PtO2 Monitor lies outside the defined range of 15©°C to 30©°C.

  AUTRE

• The calculations for PtO2 measurements require tissue temperature compensation. If you are not measuring the tissue temperature with a probe, the temperature has to be entered manually. Make sure to measure the patient's tissue temperature either hourly or prior to recording the PtO2 values for intervention. If any changes in temperature occur, use the Manual Temperature Input arrows to specify the new temperature value accordingly.

  AUTRE

• The Integra Licox PtO2 Monitor is a sensitive electronic device. When using the monitor, always handle with care. If damage is suspected, contact Integra.

  AUTRE

• Danger - Possible explosion hazard if used in the presence of flammable anaesthetics. Not suitable for use in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.

  AUTRE

• Connect the monitor to an AC power supply immediately if the low battery alarm is activated.

  AUTRE

• Do not autoclave or immerse the Integra Licox PtO2 Monitor in liquid as damage may occur. If the monitor is exposed to liquids, turn off the unit, remove the AC power adapter, remove the battery, dry the unit thoroughly, and send to biomed staff for evaluation before reapplying power.

  AUTRE

• Do not block the alarm speaker with any materials that might muffle the alarm sound.

  AUTRE

• When using the battery:- Do not heat above 80©°C.- Do not open battery.- Do not dispose of in fire.- Do not short circuit as battery may ignite, explode, leak, or get hot causing personal injury.- Replace battery with same part number only (REF # BAT1001).- Use of a battery not supplied by Integra may present a risk of fire or explosion.

  AUTRE

• There is a necessity to perform periodic checking of the MONPWR for safety.

  AUTRE

• The Integra Licox PtO2 Monitor will only store the PtO2 data from the most recent 5 days. All stored trend data older than 5 days will be lost. If monitoring is continued for more than 5 days, placement of a new PtO2 probe and Smart Card under sterile conditions is recommended. Note that replacing a probe and Smart Card with a new probe and Smart Card will reset the trend data. Please extract any data that you wish to retain prior to replacing the probe and Smart Card.

  AUTRE

• This equipment is not a blood gas device.

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• To prevent electrical shock, only use the AC power adapter supplied by Integra (REF# MONPWR). Using a different AC power adapter may not provide protection against electric shock.

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• To prevent injury to the patient, user, or other persons, make sure that the battery cover is closed securely during monitor use.

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• No modification of the Integra Licox PtO2 Monitor is allowed.

  AUTRE

• Halothane interferes with polarographic PtO2 probe measurements. It causes an overestimation, which is usually reversible within 20 minutes after discontinuation. Other commonly used anesthetic gases (e.g. N2O, Enflurane or Isoflurane) are not known to interfere with polarographic PtO2 probe measurements.

  AUTRE

• If an alarm is triggered for an overheating monitor while a Licox temperature probe is being used, the excessive heat from inside the monitor may affect the monitor's temperature measurements. If this condition occurs, the calculations for the PtO2 measurements - which require temperature compensation values - may be unreliable until the overheating monitor condition has been resolved.

  AUTRE

• If the Integra Licox PtO2 Monitor loses power and shuts down while it is connected to a patient bedside monitor, do not use the PtO2 values on the patient bedside monitor for patient measurements; the PtO2 values on the patient bedside monitor will be invalid.

  AUTRE

• To reduce the risk of electric shock, do not disassemble the Integra Licox PtO2 Monitor. Refer all servicing to qualified service personnel at Integra.

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• To prevent injury to the patient, user, or other persons, or to prevent damage to the monitor, always verify that the monitor is clamped securely to the equipment pole.

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• To prevent injury to the patient, user, or other persons, or to prevent damage to the monitor, make sure to position the cables so that they are free from all foot traffic.

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• To reduce the risk of electric shock, only connect to IEC 60601 certified bedside monitors.

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• Use of accessories, probes and cables other than those specified or provided by Integra could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

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• Use of the Integra Licox PtO2 Monitor is restricted to one patient at a time.

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• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Licox Pt02 Monitor, including cables specified by Integra. Otherwise, degradation of the performance of this equipment could result.

  AUTRE

• Only use Integra supplied accessories on the Integra Licox PtO2 Monitor. This applies in particular to probes, probe cables, battery, AC power adapter, and USB-to-RS232 adapter cable.

  AUTRE

• Only use the cleaning agents listed in Chapter 8 for cleaning and disinfecting the Integra Licox PtO2 Monitor system. Using solvents or cleaning agents not listed in Chapter 8 may damage the plastic exterior of the Integra Licox PtO2 Monitor.

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• Only use the designated Smart Card supplied with the PtO2 probe. Using the wrong Smart Card will produce incorrect PtO2 measurements.

  AUTRE

• Selecting the Alarm Off feature on the Alarm panel will disable the low PtO2 alarm limit indefinitely. Use caution if this feature is selected. To re-enable this alarm, select the Alarm On and Accept buttons.

  AUTRE

Marché principal en Belgique ; disponible dans 15 pays au total.

Dénomination commerciale

CUSA® Excel

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

10381780039792

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

038178B0036CSS3D

Numéro de référence/catalogue

ICP-90

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Monitor Adapter Cable,  Intracranial Pressure, ICP-90

URL des informations complémentaires

https://labeling.integralife.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• L99SURGICAL INSTRUMENTS, REUSABLE - OTHER

• Dispositifs médicaux de Classe I dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.