SonoSite ECG User manual

ECG Slave Cable & Adapter Kit
User Guide

Sonosite and the Sonosite logo are trademarks and registered trademarks of FUJIFILM Sonosite, Inc. in various jurisdictions.
All other trademarks are the property of their respective owners.
Part Number: P20162-01
Publication Date: October 2015
Copyright © 2015 FUJIFILM SonoSite, Inc. All Rights reserved
Manufacturer
FUJIFILM SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021 USA
T: 1-888-482-9449 or 1-425-951-1200
F: 1-425-951-1201
EC Authorized Representative
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Australia Sponsor
FUJIFILM SonoSite Australasia Pty Ltd
114 Old Pittwater Road
BROOKVALE, NSW, 2100
Australia

iii
CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
About the user guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warranty statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
About the ECG slave cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Inspecting contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Setup and use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Setting up the ECG slave cable and adapter cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Operating the ECG slave cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Pre-exam Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Cleaning, disinfecting, and storage . . . . . . . . . . . . . . . . . . . . . . . 11
Cleaning and disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Storing and transporting the ECG slave cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Disposing of the ECG slave cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ECG slave cable labeling symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

iv

1
CHAPTER 1
Introduction
The ECG slave cable and adapter kit is an optional medical accessory used for connecting
with a facility’s existing physiological/ECG patient monitor to display an ECG trace on the
screen of a SonoSite ultrasound system, without having to add extra leads/sensors to the
patient.
The ECG slave cable and adapter kit contains the ECG slave cable and ECG adapter cable.The
ECG slave cable and adapter kit are approved for use with the SonoSite ECG module and
SonoSite ultrasound products.
The ECG slave cable can be used on multiple SonoSite Ultrasound products.
About the user guide
This user guide provides information on the SonoSite ECG slave cable and adapter cable. It
is intended for a reader familiar with ultrasound and other diagnostic equipment; it does not
provide training in sonography, cardiology, or clinical practices. For information about the
ultrasound system, see its user guide and other appropriate literature.
To aid in safeguarding the patient and ensuring reliable operation of the equipment,
FUJIFILM SonoSite recommends having this user guide available for reference during all
stages of ECG module and slave cable operation.
Conventions
The user guide follows these conventions:
A WARNING describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
WARNING
To help avoid conditions that may cause harm to the patient or
damage to the cable, it is important that personnel using or
handling this cable read and understand the instructions,
warnings, cautions, and training material contained in this user
guide. If you have questions about any of the information
contained in this user guide, contact FUJIFILM SonoSite or your
local representative.

2Chapter 1
Numbered steps in procedures must be performed in order.
Single-step procedures begin with .
Items in bulleted lists do not require performance in sequence.
For labeling symbols used, see the ultrasound system user guide.
Warranty statement
The ECG slave cable and adapter cable are warranted for material and workmanship only, for a period of 12
months from date of shipment from FUJIFILM SonoSite.
The warranty does not cover damage caused by misuse by the end user, disinfecting or sterilizing incorrectly
or with chemicals not recommended by FUJIFILM SonoSite, or circumstances beyond what is considered
normal for the product’s intended application.
Technical Support
For technical support, 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 [phone]
E-mail [email protected]
Web www.sonosite.com
Europe Service Center Main: [phone]
English support: [phone]
French support: [phone]
German support: [phone]
Italian support: [phone]
Spanish support: [phone]
Asia Service Center [phone]

3
CHAPTER 2
Getting Started
About the ECG slave cable
The ECG slave cable includes the following components:
Figure 2-1 ECG slave cable components and part numbers
Intended uses
The ECG slave cable is intended to work with SonoSite ultrasound equipment and the
SonoSite ECG module.
Caution To avoid inadvertent damage to the cable, read this user guide
before handling and cleaning the ECG slave cable.
Adapter cable
P06917-50
ECG slave cable
P19958-01

4Chapter 2
Figure 2-2 ECG module
The ECG Slave Cable Kit shall be able to receive an ECG signal from the following physiological/ECG patient
monitors:
Philips Intellivue MP70, including ECG cables. (1/4” phone connector)
GE Solar 8000i, with TRAM-RAC 4A and TRAM 451N, and ECG cables. (7 pin connector)
The ECG slave cable & adapter kit is designed to function in the following operating environment:
Temperature: 10 ºC to 40 ºC
Humidity: 15% RH to 95% RH
Atmospheric pressure: 700 hPa (approximately 3011 meters or 9879 ft) to 1060 hPa.(-382 meters or -1253
ft)
Contraindications
There are no contraindications for using the ECG slave cable.
Unpacking
Follow the unpacking procedures. Contact FUJIFILM SonoSite or your local representative immediately to
report any damage or discrepancies.
To unpack the ECG slave cable
1Visually examine the shipping box, shipping case, and the ECG slave cable for any damage.
2Note any breakage or other apparent damage, retain the evidence, and notify the carrier or shipping
agency.
Caution Use the ECG slave cable only with ECG monitors or physiological equipment that has
been approved for use with the ECG slave cable kit.

ECG Slave Cable & Adapter Kit User Guide 5
3Verify that the shipping case contains the components listed on the packing list:
ECG slave cable
Adapter cable
ECG Slave Cable and Adapter Kit User Guide
Inspecting contents
After unpacking the contents, perform a visual and tactile inspection of the ECG slave cable and adapter cable.
Contact FUJIFILM SonoSite or your local representative immediately to report any damage or discrepancies.

6Chapter 2

7
CHAPTER 3
Setup and use
Setting up the ECG slave cable and adapter cable
To connect the ECG slave cable
1Plug the SonoSite ECG module into the ultrasound system.
2Plug the ECG slave cable into the ECG module.
Caution Only use the ECG slave cable and adapter kit with an approved
SonoSite ECG module.
Caution
Use the ECG slave cable only with ECG monitors or physiological
equipment that has been approved for use with the ECG slave
cable kit. For a list of approved equipment, see “Intended uses” on
page 3

8Chapter 3
3If connecting to a Philips Intellivue MP70 patient monitor, plug the ECG slave cable into the patient monitor.
4If connecting to a GE Solar 8000i patient monitor, do the following:
aPlug the ECG slave cable in to the adapter cable.
bPlug the adapter cable in to the patient monitor.

ECG Slave Cable & Adapter Kit User Guide 9
Operating the ECG slave cable
For best results when using the ECG slave cable, the output of the patient monitor should be 5V peak-to-peak
AC-coupled.
Pre-exam Inspection
Perform a visual and operational pre-exam inspection of the ECG slave cable and adapter cable prior to each
use.
To perform a pre-exam inspection
1Examine the ECG slave cable and adapter cable for damage, such as cracks or splitting.
2Once the ECG slave cable is connected, verify proper display of ECG on the FUJIFILM SonoSite ultrasound
system.
WARNING To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms. The
FUJIFILM SonoSite ECG module and slave cable is a non-diagnostic accessory.
WARNING Do not allow patient contact with the ECG Module, slave cable, or adapter cable.
Caution Excessive bending or twisting of ECG slave cable can cause failure or intermittent
operation.
Caution
Defibrillation of a patient while the ECG module is connected to the ultrasound
system may cause the ECG signal to display incorrectly or render the ECG module
inoperable.
Caution Be sure to disconnect the ECG slave cable from the patient monitor before
transporting the ultrasound system.
Note When using an ECG slave cable, the temporal alignment between the ECG display
and the displayed ultrasound 2D image or scrolling data may vary depending on the
latency imposed by the patient monitor.

10 Chapter 3

11
CHAPTER 4
Cleaning, disinfecting, and storage
Cleaning and disinfecting
Use the following approved cleaners and disinfectants on the ECG slave cable and adapter
cable:
To clean and disinfect the ECG slave cable and adapter cable (wipe method)
1Remove the cable from the system.
2Examine the ECG slave cable and adapter cable for damage, such as cracks or splitting.
3Clean the surface using a pre-moistened wipe, or a soft cloth lightly dampened with a
mild cleaning solution. Apply the cleaning solution to the cloth rather than to the cable.
4Wipe the cable surfaces with a FUJIFILM SonoSite-approved disinfectant
5Allow the cable to air dry.
Storing and transporting the ECG slave cable
Do not exceed the following environmental conditions when transporting or storing the
ECG slave cable.
Caution To avoid damaging the ECG slave cable and adapter cable, do not
sterilize.
SaniCloth Plus
Isopropanol
Caviwipes
Super SaniCloth
Hydrogen Peroxide 3%

12 Chapter 4
Temperature: -35 º C to 65 º C
Humidity: 15% to 95%
Atmospheric pressure: 500 hPa to 1060 hPa.
Disposing of the ECG slave cable
Contact FUJIFILM SonoSite or your authorized representative for disposal instructions.

13
CHAPTER 5
Safety
Patient safety is ensured only when a well-designed product is used in a safe and responsible
manner.
The ECG slave cable & adapter kit is designed to function in the following operating
environment:
Temperature: 10 ºC to 40 ºC
Humidity: 15% RH to 95% RH
Atmospheric pressure: 700 hPa (approximately 3011 meters or 9879 ft) to 1060 hPa.(-382
meters or -1253 ft)
ECG slave cable labeling symbols
The following symbols are used on the products, packaging, and containers.
Symbol Definition
Class 1 device requiring verification by the Notified Body of
sterilization or measurement features, or to a Class IIa, IIb, or
III device requiring verification or auditing by the Notified
Body to applicable Annex(es) of 93/42/EEC.
Attention, see the user guide.
Catalog number.
Authorized representative in the European Community.
Collect separately from other household waste (see European
Commission Directive 93/86/EEC). Refer to local regulations
for disposal.
REF

14 Chapter 5
Corrugated recycle.
Manufacturer.
Do not get wet.
Fragile.
Paper recycle.
Temperature limitation.
Atmospheric pressure limitation.
Humidity limitation.
Follow instructions for use.
Symbol Definition

P20162-01
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