AGA Medical Amplatzer TorqVue LP Скачать руководство пользователя страница 4

4

Symbol Definitions

The following symbols may appear on the device packaging:

Symbol

Definition

Manufacturer

EU authorized representative

Product serial number

Product lot number

Use By date

Do not reuse

Sterilized using ethylene oxide

Consult operating instructions

Caution, consult accompanying documents

Keep dry

Federal law (USA) restricts this device to 
sale by or on the order of a physician (or 
properly licensed practitioner).

Contents/Quantity

Latex-free

Indication of conformity with the essential 
health and safety requirements set out in 
European Directives

Содержание Amplatzer TorqVue LP

Страница 1: ...eter Provides a pathway through which a device is delivered D Delivery wire optional Attaches to a device for controlling its movement through the delivery catheter E Plastic vise optional Attaches to the delivery wire serving as a handle for detaching unscrewing the delivery wire from a device Indications for Use The AMPLATZER TorqVue LP delivery system is intended to provide a pathway through wh...

Страница 2: ...clude but are not limited to Device Compatibility The AMPLATZER devices compatible with the TorqVue LP delivery system are identified in Table 1 CAUTION No devices other than those listed in these tables have been tested for use with the delivery system Using untested devices with the delivery system may result in technical failures and or adverse events Air embolism Infection Arrhythmia Myocardia...

Страница 3: ...rom the delivery catheter 7 Flush all parts of the hemostasis valve Connect the distal end of the hemostasis valve to the delivery catheter Remember to close the stopcock on the sidearm of the hemostasis valve 8 Flush the loader with sterile saline 9 Capture the device in the loader according to the device s instructions for use 10 Insert the distal end of the loader into the proximal end of the h...

Страница 4: ...e By date Do not reuse Sterilized using ethylene oxide Consult operating instructions Caution consult accompanying documents Keep dry Federal law USA restricts this device to sale by or on the order of a physician or properly licensed practitioner Contents Quantity Latex free Indication of conformity with the essential health and safety requirements set out in European Directives ...

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