St. Jude Medical TactiSys Quartz Gebrauchsanweisung Seite 2

DESCRIPTION
The TactiSys™ Quartz Equipment Mounting Bracket (also described as the
"mounting bracket") and the bedrail clamp are used to secure the TactiSys™ Quartz
Equipment to the bedrail of a procedure table. The mounting bracket is available in
two configurations for mounting the TactiSys™ Quartz Equipment above or beside
the EnSite Precision™ Link, Sensor Enabled™ (see Figures 1a and 1b).
The mounting bracket consists of one (1) bracket, and four (4) screws.
The bedrail clamp is available in assorted sizes.
Figure 1a: Above mounting
Mounting Bracket/Bedrail clamp Specifications:
Model Number
TSM-ABV-GBL
TSM-BSD-GBL
BED-CLP-NA
BED-CLP-WE
BED-CLP-JP
BED-CLP-UK
INTENDED PURPOSE
The TactiSys™ Quartz Equipment mounting bracket and bedrail clamp Class I
accessories are intended to be used with the TactiSys™ Quartz Equipment. The
mounting bracket and bedrail clamps are intended to mount the TactiSys™ Quartz
Equipment to a bedrail. The TactiSys™ Quartz Equipment is intended to be used
for visualization of force information coming from the catheter tip when used in
conjunction with an EP contact force-enabled ablation catheter.
INDICATION FOR USE
The TactiSys™ Quartz Equipment Mounting Bracket and bedrail clamps are
intended to mount the TactiSys™ Quartz Equipment to a bedrail.
CLINICAL BENEFIT
As accessories, these products contribute to the realization of the intended clinical
benefit of the primary, compatible TactiSys™ Quartz equipment that they support.
PERFORMANCE CHARACTERISTICS
• Bedrail clamp: The bedrail clamp connects the TactiSys™ Quartz equipment
mounting bracket to the bedrail of a procedure table.
• Mounting bracket: The TactiSys™ mounting bracket allows the TactiSys™
Quartz epuipment to be mounted above or beside the EnSite Precision™ Link,
Sensor Enabled™ on the procedure table.
PRECAUTIONS
• Read directions prior to use.
• Ensure bedrail clamp is secure.
• Ensure mounting bracket is securely fastened to the TactiSys™ Quartz
Equipment using the screws provided.
• Federal law restricts the use of this device to sale by or on the order of a physician.
WARNINGS
• Ensure security of entire assembly prior to start of procedure.
• Failure to secure mounting bracket may result in product falling from mounting
position.
CONTRAINDICATIONS
The bedrail clamp/mounting bracket have no known contraindications.
DIRECTIONS FOR USE
1. Affix the TactiSys™ Quartz Equipment to the mounting bracket.
1.1. Align the TactiSys™ Quartz Equipment with the mounting bracket.
1.2 Affix the TactiSys™ Quartz Equipment to the mounting bracket using the
four screws provided with the mounting bracket (Figure 2).
For all other bedrail sizes, use a bedrail clamp capable of accepting 1" x 1/4"
1
(2.5 cm x 0.6 cm) TactiSys™ Quartz mounting bracket.
Instructions for Use
Geography
Mounting bracket secures TactiSys™ Quartz
Global
Mounting bracket secures TactiSys™ Quartz
Global
North America
Western
Europe
Japan Bedrail clamp, 6.35 x 31.75 mm bedrail size
UK
Figure 1b: Beside mounting
Description
Equipment above EnSite Precision™ Link,
Sensor Enabled™
Equipment beside EnSite Precision™ Link,
Sensor Enabled™
Bedrail clamp, 3/8" x 1 1/8" bedrail size
Bedrail clamp, 10 x 25 mm bedrail size
Bedrail clamp, 9 x 32 mm bedrail size
2
EN
1
1
1
1