User Guide
198 Pages
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Page 1
P11x Transducer
User Guide
Manufacturer
EC Authorized Representative
Australia Sponsor
FUJIFILM SonoSite, Inc.
FUJIFILM SonoSite B.V.
FUJIFILM SonoSite Australasia Pty Ltd
21919 30th Drive SE
Joop Geesinkweg 140
114 Old Pittwater Road
Bothell, WA 98021 USA
1114 AB Amsterdam,
BROOKVALE, NSW, 2100
T: 1-888-482-9449 or 1-425-951-1200
The Netherlands
Australia
F: 1-425-951-1201
Caution
United States federal law restricts this device to sale by or on the order of a physician.
SonoSite, SonoSite SII, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. AxoTrack is a trademark and registered trademark of Soma Access Systems, LLC in various jurisdictions. All other trademarks are the property of their respective owners. Patents: US 8,805,047; US 8,858,436; US 8,861,822; US 8,355,554; US 8,147,408; US 7,588,541; US 6,371,918: US 6,043,590: CN 1149395; CN103237499; DE 602004027882 D1; DE 60021552 D1; DE 69837416 D1; FR 1552792; FR 1175173 GB 1552792; CA 2,373,065; GB 1175173; JP3865928 and pending.
Part Number: P16677-06 Publication Date: November 2017 Copyright © 2017 FUJIFILM SonoSite, Inc. All Rights reserved.
English
P11x Transducer User Guide
Deutsch
Introduction ... 1 Document conventions ... 1 Getting Help ... 2 Intended use ... 2 Imaging modes ... 3 Cleaning and disinfecting ... 3 Preparing to use the P11x transducer ... 4 Imaging with the P11x transducer ... 4 Training mode ... 7 Measurements and calculations ... 8 Measurement accuracy ... 8 Safety ... 9 Electrostatic discharge ... 9 Guidelines for reducing MI and TI ... 9 Output display ... 10 Acoustic output tables ... 11
Español Français
Introduction
Document conventions The document follows these conventions: A WARNING describes precautions necessary to prevent injury or loss of life.
Introduction
1
Nederlands
Refer to your SonoSite ultrasound system instructions on system operations and connecting the transducer. Refer to Disinfectants for SonoSite Products for a list of products approved for cleaning and disinfecting the P11x transducer. See www.sonosite.com. For information on preparing the P11x transducer for use, see AxoTrack I Sterile Procedure Kit: Instructions for Use. The P11x transducer is designed for needle guidance procedures specifically with the AxoTrack I Sterile Procedure Kit (manufactured by Soma Access Systems, LLC).
Português
The user guide is for a reader familiar with ultrasound techniques. It does not provide training in sonography or clinical practices. Before using the system, you must have ultrasound training. To aid in safeguarding the patient and ensuring reliable transducer operation, SonoSite recommends users be trained in the use of the AxoTrack technology. See the following documents.
Italiano
This P11x Transducer User Guide provides information specific to using the P11x/10-5 MHz transducer with the AxoTrack® I Sterile Procedure Kit on the AxoTrack feature-enabled SonoSite ultrasound systems. Contact your SonoSite representative if the AxoTrack feature is not enabled.
A Caution describes precautions necessary to protect the products. A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. For a description of labeling symbols that appear on the product, see "Labeling Symbols" in the user guide.
Getting Help For technical support, please contact FUJIFILM SonoSite as follows: Phone (U.S. or Canada)
877-657-8118
Phone (outside U.S. or Canada)
425-951-1330, or call your local representative
Fax
425-951-6700
Web
www.sonosite.com
Europe Service Center
Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451
Asia Service Center
+65 6380-5581
Printed in the U.S.
Intended use The P11x transducer is intended for use in the identification of vascular structures and for use with the AxoTrack I Sterile Procedure Kit in the placement of needles and catheters in vascular structures.
2
Intended use
English
Imaging modes Table 1-1 includes the imaging modes and exam types available with the P11x transducer.
Deutsch
Table 1-1: Available exam types and imaging modes Imaging mode Exam type
2D a M Mode
CPDb
Colorb
PW Doppler
CW Doppler Español
Arterial Venous
Note
Français
a. The optimization settings for 2D are Res, Gen, and Pen. b. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a range of PRF settings for Color depending on the setting selected.
A special training mode is available for use with Blue Phantom models. See “To set up training mode” on page 7.
The P11x transducer must be cleaned and disinfected before each exam. In addition to protecting the patients and employees from disease transmission, the disinfectant you choose must be safe for the transducer. Exposing the P11x transducer to non-recommended chemical sterilants or submersion of the transducer beyond recommended levels may result in transducer degradation over time, leading to poor image quality or transducer failure. See Disinfectants for SonoSite Products.
Português
Caution
Italiano
Cleaning and disinfecting
Please follow the cleaning and disinfection instructions available at www.sonosite.com. Nederlands
Imaging modes
3
Preparing to use the P11x transducer Make sure that the AxoTrack I Sterile Procedure Kit packaging has not been opened prior to use. Before using the P11x transducer with the AxoTrack I Sterile Procedure Kit, read the warnings and the instructions in the AxoTrack I Sterile Procedure Kit: Instructions for Use. WARNINGS
Before use, inspect the needle guide receiver on the P11x transducer for excessive wear. If you notice excessive wear, contact FUJIFILM SonoSite. The magnet attached to the needle hub may cause electrical interference due to its proximity with other electronic equipment. The magnet must be kept at least 15 cm (6 in) away from an implanted or attached medical device. See AxoTrack I Sterile Procedure Kit: Instructions for Use for more information. To avoid device damage or patient injury, do not use the P11x compatible AxoTrack I Sterile Procedure Kit on patients in proximity to pacemakers or medical electronic implants. The needle includes a magnetic hub that is used to track the position of the needle when the sterile procedure kit is attached to the P11x . The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect. Bacterial or viral contamination can be caused by: Removing the sterile needle guide plug before the transducer is placed in the bottom shield Assembling the kit parts in the incorrect order Not using sterile gel When using the P11x transducer with the disposable kit, ensure that the disposable shield is properly attached.
Imaging with the P11x transducer WARNING
When using the P11x transducer with the disposable kit, ensure that the sterile field is maintained throughout the disposable kit assembly procedure.
Before imaging with the P11x transducer, read these warnings and the instructions in the AxoTrack I Sterile Procedure Kit: Instructions for Use. WARNING
4
Failure to make contact between the magnet and the surface of the sterile shield may lead to inaccurate needle tracking and loss of the needle graphic on the ultrasound system.
Preparing to use the P11x transducer
English
WARNINGS
Applying too much force with the needle clamp engaged may lead to needle bending, needle breakage, inaccurate needle tracking, or loss of the needle graphic on the ultrasound system.
Deutsch
Twisting the syringe to disengage from the needle hub can cause the needle to spin in the clamp, resulting in misorientation of the needle bevel. This misorientation can direct the guide wire into the vessel wall, leading to procedure delay, patient discomfort, or patient injury. Needle bending due to torquing to reposition the needle in tissue may lead to procedure delay from feed wire difficulties or an inability to aspirate.
Español
Application of too much needle force with the needle clamp engaged, or attempting to reposition the needle in tissue, may lead to needle breakage, and, subsequently, procedure delay, patient discomfort, or patient injury. Failure to orient the needle bevel correctly can lead to difficulty advancing the guide wire, procedure delay, patient discomfort, or patient injury.
Français
Virtual needle position error due to transducer, kit, or ultrasound system failure can lead to procedure delay, patient discomfort, or patient injury. Stop the procedure and contact FUJIFILM SonoSite if the system displays warnings or if you notice atypical virtual needle behavior, such as needle image misalignment to the ultrasound image, flashing, or disappearing.
Italiano
Attempting to reorient the transducer with the needle inserted can lead to procedural delay, patient discomfort, or patient injury. Partial engagement of the needle clamp or failure to fully set the needle clamp can lead to procedure delay, patient discomfort, or patient injury.
Português
Inserting the needle at too steep of an angle may lead to procedure delay due to difficulty feeding a guide wire or having to restart the procedure. To turn on the guideline
Do not rely solely on the visibility of the needle tip on the system display. Use other tactile or visual indicators to confirm you are at or in the vessel. (Example: indentation of anterior wall, decreased resistance as the needle enters the vessel lumen, or blood return in the needle.) 1 Choose an exam type: Press the EXAM key, and select from the menu. 2 Press Guide. A dotted guideline appears on the display.
Imaging with the P11x transducer
5
Nederlands
Before imaging with the P11x transducer, consider using a standard transducer to visualize the anatomy that includes the intended target. For more information, see the ultrasound system user guide.
Figure 1-1 Guideline on an ultrasound system 3 Image with the P11x transducer until the guideline on the display is aligned with the intended target. Note
Follow the instructions in the AxoTrack I Sterile Procedure Kit: Instructions for Use for holding the probe properly. Failure to do so can lead to unstable positioning on the patient’s skin and unintended lateral movement of the needle.
4 Insert the needle. The virtual needle image appears superimposed on the guideline. The system displays the virtual depth in centimeters in the lower-right corner of the display. Note
6
When inserting the needle in Color Mode, the initial entry of the needle may be obscured by the color bars.
Imaging with the P11x transducer
English Deutsch Español Français Italiano
Figure 1-2 Virtual needle image and depth (lower-right corner of the display) on an ultrasound system 5 Follow the instructions in the AxoTrack I Sterile Procedure Kit: Instructions for Use to insert the needle to the desired target and complete the procedure.
Note
Maintain the magnet in contact with the magnet rail. Movement of the magnet away from the rail will cause the virtual needle to disappear from the display.
Nederlands
Training mode To set up training mode 1 Press the PATIENT key. 2 Select New/End. 3 Type @AXOTRACK in the Last Name field.
Training mode
Português
If the image quality is not adequate, review the instructions in the AxoTrack I Sterile Procedure Kit: Instructions for Use to confirm the correct assembly and alignment of the kit components.
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4 Leave all other fields blank. 5 Select Done. The guideline is blue when training mode is active. To exit training mode 1 Press the PATIENT key. 2 Select New/End. 3 Type any name other than @AXOTRACK in the Last Name field. 4 Select Done.
Measurements and calculations The distance between the tip of the graphic overlay (center of needle graphic ellipse) and the sonographic tip is within 2 mm plus 1% of the depth of the needle tip. Only calculations related to 2D, M Mode, and Color apply to the P11x transducer.
Measurement accuracy The measurements provided by the system are verified on a static bench model and do not account for acoustic anomalies of the body. The 2D linear distance measurement results are displayed in centimeters with two places past the decimal point. The linear distance measurement components for the P11x transducer have the accuracy of +/- 0.4 cm.
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Measurements and calculations
English
Safety Electrostatic discharge Unless following ESD precautionary procedures, all users and staff must be instructed not to connect to or to touch (with body or hand-held tools) pins of connectors that have the ESD Sensitive Devices symbol:
Deutsch
WARNING
Español
If the symbol is on a border surrounding multiple connectors, the symbol pertains to all connectors within the border. ESD precautionary procedures include the following: Receive training about ESD, including the following at a minimum: an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice, and the damage that can occur to electronic components if equipment is touched by an individual who is electrostatically charged. Prevent the buildup of electrostatic charge. For example, use humidification, conductive floor coverings, nonsynthetic clothing, ionizers, and minimizing insulating materials. Discharge your body to earth. Use a wrist strap to bond yourself to the ultrasound system or to earth.
Français Italiano
Guidelines for reducing MI and TI Table 1-2: MI Transducer
Depth Português
P11x
Nederlands
Decrease or lower setting of parameter to reduce MI. increase or raise setting of parameter to reduce MI.
Safety
9
Table 1-3: TI (TIS, TIC, TIB) CPD Settings Transducer
Box Width
Box Height
Box Depth
PRF
Depth
Optimize
P11x
Decrease or lower setting of parameter to reduce MI. increase or raise setting of parameter to reduce MI.
Output display Table 1-4: TI or MI ≥1.0 Transducer
Index
2D/ M Mode
CPD/ Color
PW Doppler
CW Doppler
P11x
MI
No
Yes
-
-
TIC, TIB, or TIS
No
No
-
-
Table 1-5: Transducer Surface Temperature Rise, Internal Use (°C ) Test
AxoTrack
Still air
17.0
Simulated use
8.9
10
Safety
English
Acoustic output tables Table 1-6 indicates the acoustic output for the SonoSite Edge, M-Turbo, and S Series ultrasound systems. Table 1-6: Transducer Model: P11x Operating Mode: Color
Index Label
Aaprt≤1 Aaprt>1
(a)
-
#
-
-
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
deq@Pllmax
(cm)
Focal Length
-
(b)
-
#
- -
4.76
#
-
-
-
#
# #
- -
- -
- -
# #
0.675 1425 3.64 -
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
(W/cm2)
Português
IPA.3@MImax
TIC
Italiano
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
2.0
Non-scan
Français
Associated Acoustic Parameter
Non-scan Scan
W0
Dim of Aaprt
Other Information
(MPa)
1.2 2.64
TIB
Español
Global Maximum Index Value pr.3
M.I.
Deutsch
TIS
417
Safety
Nederlands
Operating Control Conditions
Control 1: Exam Type Ven Control 2: Mode Color/CPD Control 3: 2D Optimization/Depth Any/3.3cm Control 4: Color Optimization/PRF Low/434Hz Control 5: Color Box Position/Size Any/Tall (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
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Table 1-7 indicates the acoustic output for SonoSite Edge II and SonoSite SII ultrasound systems. Table 1-7: Transducer Model: P11x Operating Mode: Color TIS Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
(MPa)
1.2 2.64
Non-scan Scan
Aaprt≤1 Aaprt>1
(a)
-
#
-
-
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
Other Information
M.I.
TIB
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
deq@Pllmax
(cm)
Focal Length IPA.3@MImax
2.0
Non-scan
TIC
-
(b)
-
#
- -
4.76
#
-
-
-
#
# #
- -
- -
- -
# #
0.675 1425 3.64 -
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
(W/cm2)
417
Operating Control Conditions
Control 1: Exam Type Ven Control 2: Mode Color/CPD Control 3: 2D Optimization/Depth Gen/5.6 cm Control 4: Color Optimization/PRF Low/374Hz Control 5: Color Box Position/Size Any/Tall (a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. # No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
12
Safety
P16677-06
*P16677-06*