Edwards VLV6R416 Bedienungsanleitung

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Français . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Deutsch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Nederlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Dansk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Svenska . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Ελληνικά . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

English

VolumeView Set
The devices described herein may not all be licensed in accordance with Canadian law or approved for sale
in your specific region.
For single use only
Carefully read these instructions for use, which address the warnings, precautions, and
residual risks for this medical device.
1.0 VolumeView Set Components
• Edwards VolumeView femoral arterial catheter with insertion kit
• Edwards VolumeView venous injectate kit: TruWave disposable pressure transducer (DPT) and
VolumeView thermistor manifold.
• Edwards VolumeView sensor
2.0 Additional Components Required
• Cooled normal saline filled luer lock syringe(s)
• Central venous catheter (CVC)
• EV1000 clinical platform
These are general instructions for setting up the disposable components of the VolumeView system. Kit
configurations and procedures may vary according to institutional preferences.
3.0 Intended Use/Purpose
The VolumeView set, when used in conjunction with the Edwards EV1000 clinical platform, is designed for
measurement of continuous and intermittent transpulmonary thermodilution (TPTD) parameters. The
VolumeView set enables measurement of intermittent cardiac output (iCO) and a range of volumetric
parameters including extravascular lung water (EVLW) and global end-diastolic volume (GEDV).
4.0 Description
The VolumeView set from Edwards Lifesciences in combination with the applicable Edwards hemodynamic
monitoring platform enables the display of valuable volumetric parameters. The VolumeView set is able to
offer you a unique clear, visual depiction of patient physiologic status.
The benefits of hemodynamic monitoring may lead to improved data driven clinical decision making for
medically necessary intervention and/or clinical re-evaluation.
Device risks include thrombosis, sepsis/infection, bleeding, peripheral ischemia, inappropriate/unintended
treatment, hematoma, tissue damage, vessel perforation, embolism, adverse reaction to device materials,
and/or delay in treatment.
Device performance, including functional characteristics, have been verified in a comprehensive series of
testing to support the safety and performance of the device for its intended use when used in accordance
with the established Instructions For Use.
This device is used by medical professionals who have been trained in the safe use of invasive
hemodynamic technologies in accordance with their institutional guidelines.
5.0 MRI Information
MR Conditional
Non-clinical testing has demonstrated that the VolumeView catheter is MR Conditional.
It can be scanned safely under the following conditions:
• Static magnetic field of 1.5 Tesla (T) or 3.0 Tesla (T)
• Highest spatial gradient field of 720 gauss/cm or less
Edwards, Edwards Lifesciences, the stylized E logo, EV1000, TruWave, and VolumeView are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
DIRECTORY
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Česky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Suomi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Български . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Română . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
• Maximum whole-body-averaged specific absorption rate (SAR) of 2.9 W/kg for 15 minutes of
scanning.
• Normal mode operation, as defined in IEC 60601-2-33, of the MR system.
In non-clinical testing and analysis, the VolumeView catheter was determined to produce a maximum
temperature rise of 2.0 °C above background for a SAR of 2.0 W/kg for 15 minutes of scanning in a 1.5 T
whole body cylindrical bore MR system. The projected rise above background was 2.4 °C for a SAR of
2.0 W/kg in a 3.0 T whole body cylindrical bore MR system. These calculations overestimate the true in vivo
rise, since the cooling effects of blood are not considered.
The maximum image artifact extends as far as 10 mm from the catheter for spin echo images and gradient
echo images.
The catheter has not been evaluated in MR systems other than 1.5 T or 3.0 T .
Non-clinical testing has demonstrated that the VolumeView venous injectate kit is MR Conditional
according to the following conditions:
• Static magnetic field of 3 Tesla or less
• Spatial gradient field of 720 gauss/cm or less
Note: The VolumeView injectate kit has minor metallic components that do not come into
contact with patients during the intended use. Furthermore, the metallic components are
insulated and isolated from the patient during their intended use and as such, it was only
necessary to evaluate this product for magnetic field interactions. MRI-related heating and
artifacts were not characterized for this product because it is not a medical implant.
6.0 Indications
The EV1000 clinical platform (including the VolumeView set) is indicated for use primarily for critical care
patients in which the balance between cardiac function, fluid status and vascular resistance needs
continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time
and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an
Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 clinical
platform (including the VolumeView set) may be used in all settings in which critical care is provided.
The VolumeView catheter is indicated for femoral artery insertion.
7.0 Contraindications
The VolumeView femoral arterial catheter is contraindicated for venous insertion. Relative
contraindications include: placement of a central venous catheter or of a femoral arterial catheter in
patients who have severe coagulation abnormalities, burned or infected skin at insertion point, or severe
atherosclerosis.
8.0 Warnings
• Please read this manual before use. Retain for future reference.
• Use sterile technique when connecting the fluid path components of the system.
• Do not use if expiration date is passed.
• This device is designed, intended and distributed for SINGLE USE ONLY. DO NOT
RE-STERILIZE OR REUSE this device. There are no data to support the sterility,
non-pyrogenicity and functionality of the device after reprocessing. Such action could lead
to illness or an adverse event as the device may not function as originally intended.
9.0 Cautions
• Femoral catheter usage may be associated with thrombotic, infectious or hemorrhagic
complications and distal limb ischemia.
• Assess limb distal to femoral arterial catheter before and after placement for potential
compromised limb perfusion per institutional policies.
• You may receive erroneous results if pressure transducer is not "zeroed" .
• Erroneous measurements can be caused by an incorrect catheter position or by
electromagnetic disturbance (such as an electric blanket).
• Repeat the measurement if the results are implausible.
• Do not withdraw a PTFE-coated guidewire through a metal cannula needle as this may
damage the guidewire coating.
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Eesti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Lietuvių . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Latviešu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Русский . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Srpski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
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Hrvatski