X-Porte PowePark User Guide Ver 03

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.

PowerPark, SonoSite, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation. All other trademarks are the property of their respective owners. Patents: US 7,591,786; D625014; D625015; and pending.

Part Number: P13405-06 Publication date: June 2019 Copyright © 2019 FUJIFILM SonoSite, Inc. All rights reserved.

English

Contents

Deutsch

Introduction ... 1 Document conventions ... 1 Changes in this version -03 ... 2 Getting Help ... 2 About the PowerPark ... 3 Docking the stand ... 3 Troubleshooting ... 5 Cleaning and disinfecting ... 7 Safety ... 9 Electrical safety ... 9 Equipment Safety ... 10 Electromagnetic compatibility (EMC) ... 10 Electrostatic discharge ... 10 Labeling symbols ... 11 Specifications ... 12

Español

WARNING

To avoid the risk of patient injury, misdiagnosis, or user injury, read all the warnings in the user guide, supplemental guides, or the ultrasound system onboard help.

Português

Document conventions The document follows these conventions: A WARNING describes precautions necessary to prevent injury or loss of life. 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” on page 11.

Contents

Italiano

The PowerPark User Guide explains how to use, clean, and disinfect the PowerPark. It also provides information on safety and specifications. To attach or remove the PowerPark from the stand, refer to the PowerPark Assembly Instructions. For information on the stand or ultrasound system, see the user guide or the ultrasound system on-board help.

Français

Introduction

1

Changes in this version -03 Feature

Description

Improved design

Design changes to the dock and stand-mounted assembly necessitate changes to the procedure for resetting breakers. For more information, see “To reset the stand module circuit breakers” on page 6.

Updated cleaning and disinfection instructions

Cleaning and disinfection instructions have been updated to comply with the latest FDA guidelines. For more information, see “Cleaning and disinfecting” on page 7.

Getting Help For technical support, please contact FUJIFILM SonoSite as follows: Phone (U.S. or Canada)

+1-877-657-8118

Phone (outside U.S. or Canada)

+1-425-951-1330, or call your local representative

Fax

+1-425-951-6700

Email

[email protected]

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.

2

PowerPark User Guide

English

About the PowerPark

The PowerPark includes two parts: the dock (which remains on the floor against the wall) and the standmounted module (which attaches to the underside of the stand).

Español

Ultrasound system stand

Deutsch

The PowerPark is a power docking station for the SonoSite X-Porte ultrasound system, SonoSite SII stand, the SonoSite Edge stand, the V-Universal Stand, and the H-Universal Stand. It lets you dock the stand-without manually connecting the power cord-to charge the PowerPack battery (if present) and the ultrasound system battery.

Français

Stand-mounted module Dock

Italiano

Figure 1 PowerPark includes two main components.

Docking the stand Português

To dock the stand 1 Make sure the AC power cord is disconnected from the system stand.

About the PowerPark

3

2 Wheel the stand backward into the dock. See Figure 2 on page 4. The stand module (on the underside of the stand) snaps into place as it connects with the dock, and the connection indicator glows green.

Figure 2 Wheel the stand into the dock to connect (shown with the H-Universal Stand). To undock the stand 1 Make sure the AC power cord is disconnected from the system stand. 2 Wheel the stand away from the dock. The connection indicator turns off. To manually connect to AC power If necessary, you can manually connect to AC power, for example, if you need to use the system despite a depleted battery.  Connect the system power cord to the AC power cord socket on the stand module and to the electrical

outlet.

4

WARNING

To avoid the risk of electrical shock, make sure the AC power cord is disconnected from the PowerPark stand module whenever the stand is docked.

Caution

To avoid a possible trip hazard, do not connect to AC power manually if the stand is docked.

PowerPark User Guide

English Deutsch Español

Figure 3 The AC adapter enables you to manually connect to AC power (shown with the H-Universal Stand).

Troubleshooting Solution

PowerPark does not charge the battery

Make sure that the electrical outlet has power. Make sure that the dock circuit breaker is turned on. Reset the stand-module circuit breaker if tripped. Make sure that the stand module is fully connected to the dock.

Stand module does not connect to the dock

Make sure that the floor is clean, flat, and rigid. Avoid thick carpeting.

Italiano

Symptom

Français

Table 1: Symptoms and solutions

Português

To turn the dock circuit breaker on or off The circuit breaker on the PowerPark dock is typically set to the ON position but trips if there is a power event (for example, a power surge). The circuit breaker is a means of disconnection from mains power. 1 Undock the stand. 2 Disconnect the power cord from the wall outlet, and pull the PowerPark dock away from the wall. The circuit breaker is now accessible. See Figure 4 on page 6.

Troubleshooting

5

3 Press the circuit breaker to the desired position: ON ( | ) or OFF (O).

Figure 4 The dock circuit breaker is on the side toward the wall. To reset the stand module circuit breakers One or both of the circuit breakers on the stand module trip if there is a power event (for example, a power surge) and may need to be reset. 1 Undock the stand, and remove the ultrasound system and any loose items. 2 Lock the wheels, and tip the stand onto its side, allowing access to its underside. WARNING

For SonoSite X-Porte, we recommend keeping the system upright and accessing the circuit breakers from underneath. Tipping the system could cause injury.

3 Press in on each circuit breaker switch until it closes. See Figure 5 on page 7. On a correctly closed circuit breaker, the switch is pressed in. On a tripped circuit breaker, the switch is popped up and exposes a white plastic area. Note

6

If you cannot press down the switch and if no white area is exposed, the circuit breaker is closed.

PowerPark User Guide

English

Breaker location

Deutsch

Breaker tripped

Español

Breaker closed

Français

Figure 5 The stand-module circuit breakers are on the stand’s underside.

Cleaning and disinfecting WARNINGS To avoid electrical shock, before cleaning, always disconnect the PowerPark dock

from AC power.

Italiano

To avoid injury, always use protective eyewear and gloves when performing cleaning and disinfecting procedures. To avoid infection: Ensure that the solution expiration date has not passed.

Caution

Use only recommended cleaners or disinfectants on surfaces. Immersion-type disinfectants are not tested for use on surfaces.

To clean and disinfect the PowerPark stand module Whenever you clean the system stand, be sure to also clean the attached PowerPark stand module.

Cleaning and disinfecting

7

Português

The level of disinfection required for a product is dictated by the type of bodily fluids or tissue it comes into contact with during use. Ensure that the solution strength and duration of contact are appropriate for the equipment. For information, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology (APIC) and FDA.

You can clean and disinfect the exterior surface of the PowerPark stand module using a recommended cleaner or disinfectant. For the most recent list of approved products, see Cleaning and Disinfecting FUJIFILM SonoSite Products, available at www.sonosite.com. Caution

Do not allow cleaning solution or disinfectant to contact the PowerPark electrical connectors.

1 Turn off the ultrasound system and any accessory equipment. Disconnect the stand from the PowerPark dock or unplug the power cord. 2 Clean the stand module surfaces to remove any debris or bodily fluids. Use the following procedure: a Use either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. b Remove all gel, debris, and bodily fluids from the PowerPark stand module. 3 With a new wipe, clean all parts of the PowerPark stand module by wiping from the clean areas to the soiled areas. This method helps to avoid cross-contamination. Follow the chemical manufacturer’s instructions regarding temperature and wet contact time. Monitor the PowerPark parts for wet appearance, and reapply with a new wipe if no longer wet. 4 Allow the PowerPark stand module to air dry in a clean, well-ventilated space. To clean the PowerPark dock Clean the PowerPark dock periodically, or whenever it appears dirty or comes into contact with biomatter or bodily fluids. Caution

Do not allow cleaning solution or disinfectant to come into contact with the PowerPark electrical connectors.

1 Undock the stand, and disconnect the PowerPark dock from the AC power. 2 Clean the outside surface of the PowerPark dock to remove any debris or bodily fluids. Use either a premoistened wipe or a soft cloth dampened with cleaner or disinfectant. 3 With a new wipe, clean all parts of the PowerPark dock by wiping from the clean areas to the soiled areas. This method helps avoid cross-contamination. Follow the chemical manufacturer’s instructions regarding temperature and wet contact time. Monitor the PowerPark parts for wet appearance and reapply with a new wipe if they are no longer wet. 4 Allow the PowerPark dock to air dry in a clean, well-ventilated space.

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PowerPark User Guide

English

Safety For maximum safety, observe all of the warnings and cautions in this section.

Deutsch

Electrical safety Table 2: Electrical safety classification The PowerPark is classified as Class I equipment.

Non AP/APG

The PowerPark is not suitable for use in the presence of flammable anesthetics.

WARNINGS

Español

Class I equipment

Français

To avoid the risk of a shock hazard: Do not plug the power cord of the PowerPark dock or PowerPark stand module into a multiple portable socket outlet (MPSO) or use an extension cord. Make sure the AC power cord is disconnected from the PowerPark stand module whenever the stand is docked.

Italiano

To avoid the risk of electrical shock and possible fire: Use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can only be achieved when the equipment is connected to a receptacle marked “Hospital Only,” “Hospital Grade,” or the equivalent. The grounding wire must not be removed or circumvented.

Português

Use only accessories and peripherals recommended by FUJIFILM SonoSite, including the power supply. Use the PowerPark only within the voltage and current limits specified on its ratings label. Inspect the power supply, plugs, cables, and power cords on a regular basis for damage. Do not place the PowerPark dock in a wet environment. To avoid system malfunction and the risk of electrical shock, follow the PowerPark assembly instructions.

Safety

9

Equipment Safety Cautions

Excessive bending or twisting of cables can cause a failure or intermittent operation. Improper cleaning or disinfecting of any part of the accessories and peripherals can cause permanent damage. For cleaning and disinfecting instructions, see Cleaning and Disinfecting FUJIFILM SonoSite Products, available at www.sonosite.com.

Electromagnetic compatibility (EMC) See the Safety section of the ultrasound system user guide for information on electromagnetic compatibility with IEC 60601-1-2, including the Manufacturer’s Declaration.

Electrostatic discharge WARNINGS

Unless following ESD precautionary procedures, all users and staff must be instructed not to connect or to touch (with body or hand-held tools) the pins of connectors that have the ESD Sensitive Devices symbol: 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, non-synthetic clothing, ionizers, and minimizing insulating materials. Ground yourself to discharge any static charge. Use a wrist strap to bond yourself to earth ground.

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PowerPark User Guide

English

Labeling symbols For additional labeling symbols used, see the ultrasound system on-board help or user guide. Definition

Deutsch

Symbol

Follow instructions for use.

Electrostatic sensitive devices Español

Class 1 device indicating manufacturer’s declaration of conformance with Annex VII of 93/42/EEC.

Français

Attention, refer to the user guide.

Collect separately from other household waste (refer to European Commission Directive 93/86/EEC). Refer to local regulations for disposal.

Português

Manufacturer, or Manufacturer and date of manufacturer Alternating current Protective earth (ground)

On (power)

Safety

Italiano

Pollution Control Logo. (Applies to all parts/products listed in the China RoHS disclosure table. May not appear on the exterior of some parts/products because of space limitations.)

11

Symbol

Definition Off (power)

Specifications Dimensions Approximate dimensions of the PowerPark dock are as follows: Width: 15.00 in (38.1 cm) Depth: 4.88 in. (12.4 cm) Length: 4.88 in. (12.4 cm) Weight (including cord): 11.3 lbs. (5.1 kg)

Environmental limits Operating: 10 to 40°C; 15 to 95% R.H.; 700 hPa to 1060 hPa Shipping/Storage: -35 to 65°C; 15 to 95% R.H.; 500 hPa to 1060 hPa

Electrical PowerPark Dock Supply Input: 100-240 VAC, 50/60 Hz, 8-3.3 A PowerPark Stand-Module Supply Input: 100-240 VAC, 50/60 Hz, 8-3.3 A

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PowerPark User Guide

P13405-06

*P13405-06*