Front Back - Acutus Medical AcQMap Bedienungsanleitung

Instructions for Use
AcQMap® Patient Electrode Kit
The AcQMap Patient Electrode Kit is designed to be used with the AcQMap® High
Resolution Imaging and Mapping Systems 900000 and 900100 to provide cardiac
signals, AcQMap localization and system reference.
The AcQMap Patient Electrode Kit, Model 800605, includes the following components:
• Monitoring Electrodes (15)
- 3M Red Dot™ 2670-5 (3)
• Localization Electrodes (6) and System Reference (1)
- Acutus Medical®
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
WARNINGS AND PRECAUTIONS
Patient Electrodes - To avoid patient injury, use care in applying and removing Patient
Electrodes (Monitoring and Localization).
• To avoid patient injury, the System Reference Electrode must be the first Patient
Electrode connected to the AcQMap Console at the beginning of the study and
the last Patient Electrode to be disconnected at the end of the study. Remove the
System Reference Electrode from the patient's skin prior to disconnecting the
electrode lead-wire from the AcQMap Console.
• Ensure that all Patient Electrodes and connections are not in contact with each
other or any other surface electrodes from other equipment (e.g., ablation return
electrodes, defibrillation electrodes), electrical ground or metallic objects.
• Do not warm the Monitoring Electrodes or the Localization Electrodes prior to
application to the patient.
• Do not use any Patient Electrodes if the packaging seal is not intact, the conductive
adhesive is dry, or the "Use By" date has passed.
• Before applying Patient Electrodes, ensure the application site is hair-free, clean
and dry.
• Re-use and repositioning of disposable electrodes may result in degradation of
performance of the AcQMap High Resolution Imaging and Mapping System.
• Do not place electrodes on skin folds, dry or damaged skin.
• Do not modify electrodes prior to use.
• MRI compatibility for the electrodes contained in the AcQMap Patient Electrode Kit
has not been tested by Acutus Medical.
• Any serious incident, including but not limited to death or serious deterioration of
a patient's health, that has occurred in relation to the device should be reported to
the manufacturer and the Competent Authority of the Member State in which the
user and/or patient is established.
PATIENT ELECTRODE PLACEMENT
Refer to Figure 1 and align the electrodes per the gridlines for the correct placement of
the Patient Electrodes. When placing the electrodes, ensure that the cables are directed
to the side of the table where the AcQMap Console is located. Start with the patient
sitting upright on the fluoroscopy table.
a. Place the System Reference Electrode on the lower right back. (Figure 1) Con-
nect the System Reference Electrode to the front panel of the AcQMap Console.
b. Place Localization Electrode 5 (yellow) on the patient's back in a horizontal position
with the superior border of the patch at the level of T3. (Figure 1)
c. Place Localization Electrode 3 (red) in a horizontal position across the lower back. (Figure 1) This electrode will be parallel to Electrode 6. (see Step f)
d. Ensure that both Localization Electrodes are flat and have adequate adhesion to the patient's skin. Help the patient lay down and route the connector cables to the same side as the AcQMap Console.
e. Place Localization Electrode 4 (green) in a horizontal position with the superior edge at the level of the sternal notch. (Figure 1)
f. Place Localization Electrode 6 (orange) in a horizontal position across the abdomen midway between the xyphoid process and umbilicus. (Figure 1)
g. Place Localization Electrode 2 (gray) in a vertical position across the right ribs. (Figure 1) This electrode should be centered on the heart.
h. Place Localization Electrode 1 (black) in a vertical position across the left ribs. (Figure 1) This electrode should be centered on the heart.
i. Connect all Localization Electrodes 1 through 6 to their color-coded receptacles on the front panel of the AcQMap Console.
j. Place the ten Monitoring Electrodes as shown in Figure 1.
k. Connect the Monitoring Electrodes to the AcQMap Console using the AcQMap EGM Input Cable.
NOTE: If at any time during the study, the AcQMap Catheter appears flat (i.e., 2 dimensional), the most likely cause is a poorly attached or poorly located Localization Electrodes.
The Localization Electrodes should be inspected as soon as possible and replaced if necessary. After replacing any Localization Electrode, a new anatomy should be generated.
NOTE: AcQMap System 900000 does not require a right leg electrode.
RIGHT SIDE FRONT
SIDES FRONT BACK
Acutus Medical®
Not made with natural rubber latex.
1 BLACK
2 GRAY
3 RED
4 GREEN
5 YELLOW
6 ORANGE
*
/
AG
BLUE
Figure 1. Placement of Localization and Monitoring Electrodes.
*The Blue Arrow symbol replaces the AG symbol previously used in system 900000.
en
BACK LEFT SIDE
MONITORING
SYSTEM
REFERENCE
3M Red Dot™
2670-5
Upper left side torso mid-axillary line at level of 4th
intercostal space
Upper right side torso mid-axillary line at level of 4th
intercostal space
Lower back, opposite 6 – (Orange) on abdomen
Upper chest, top edge at level of sternal notch, opposite
5 (Yellow) on upper back
Upper back, top edge at level of T3, opposite 4 (Green)
on upper chest
Abdomen, midway between xyphoid process and
umbilicus, opposite 3 (Red) on lower back
Lower back, rightward between spine and 2 – (Gray)
and below level of 3 – (Red)
Pg. 3