PowerPark User Guide

English

PowerPark User Guide for Sonosite PX and Sonosite LX

Deutsch

Introduction... 1 Document conventions ... 1 Getting help... 2 About the PowerPark ... 2 Docking the stand ... 3 Troubleshooting ... 4 Cleaning and disinfecting... 6 Safety ... 7 Electrical safety... 7 Equipment safety... 8 Hazardous materials... 9 Electromagnetic compatibility (EMC)... 9 Electrostatic discharge ... 9 Labeling symbols... 10 Specifications... 14 Dimensions... 14 Environmental limits... 14 Electrical... 14

Español Français

Introduction

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 on-board help.

Nederlands

Document conventions The user guide follows these conventions: WARNING describes precautions necessary to prevent injury or loss of life.

A

Caution describes precautions necessary to protect the products.

Introduction

한국어

A

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.

1

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. Single-step procedures begin with . For a description of labeling symbols that appear on the product, see “Labeling symbols” on page 10.

Getting help For technical support, please contact FUJIFILM Sonosite as follows: United States and Canada

+1 877-657-8118

Europe and Middle East

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 and Pacific

+61 2 9938 8700

Other regions

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

Fax

+1 425-951-6700

Email

Main: [email protected] United Kingdom: [email protected] Europe, Middle East, and Africa: [email protected] Asia and Pacific: [email protected]

Web

www.sonosite.com

About the PowerPark The PowerPark is a power docking station for the Sonosite PX and Sonosite LX ultrasound systems and stand. It lets you dock the stand-without manually connecting the power cord-to charge the stand battery (if present) and the ultrasound system battery.

2

About the PowerPark

The PowerPark includes two parts: the dock (which remains on the floor against the wall) and the stand-mounted module (model P25003) which attaches to the underside of the stand. English

Stand-mounted module

Deutsch

Ultrasound system stand

Dock

Español

Figure 1 PowerPark includes two main components: the stand-mounted module, and the dock.

Français

Docking the stand To dock the stand 1 Make sure that the system’s power cord is disconnected from AC power. 2 Wheel the stand backward into the dock.

Italiano

The stand module (on the underside of the stand) snaps into place as it connects with the dock.

Nederlands 한국어

3 To keep the stand in its place, lock one or more of the wheels.

Docking the stand

3

4 Verify PowerPark is charging by confirming that the connection indicator on the stand base glows green.

To undock the stand 1 Unlock the stand’s wheels. 2 Wheel the stand away from the dock. The connection indicator turns off.

Troubleshooting Table 1: Symptoms and solutions Symptom

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.

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.

4

Troubleshooting

2 Disconnect the power cord from the wall outlet, and pull the PowerPark dock away from the wall. The circuit breaker is now accessible. English

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

Deutsch

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.

Español

1 Locate the two breakers on the end of the power module under the stand base, near the stand height adjustment pedal. 2 Press in on each circuit breaker switch until it closes. See the following figure. On a correctly closed circuit breaker, the switch is pressed in.

Français

On a tripped circuit breaker, the switch is popped up and exposes a white plastic area. Note If you cannot press down the switch and if no white area is exposed, the circuit breaker is closed.

Italiano Nederlands

Troubleshooting

Breaker tripped

한국어

Breaker closed

5

Cleaning and disinfecting WARNINGS To avoid electrical shock, before cleaning, always disconnect the PowerPark dock from AC power. 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. The level of disinfection required for a product is determined by the type of tissue it has contacted or will contact 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. Caution Use only approved cleaners or disinfectants on surfaces.

The exterior surfaces of the PowerPark stand module and the PowerPark dock should be kept clean. Whenever you clean the system stand, be sure to also clean the attached PowerPark stand module. Clean and disinfect the PowerPark dock periodically, or whenever it appears dirty or comes into contact with biomatter. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a list of approved cleaners and disinfectants. Caution Do not allow cleaning solution or disinfectant to come into contact with the PowerPark electrical connectors.

To clean the PowerPark stand module and dock 1 Disconnect the PowerPark components from any power source: For the PowerPark stand module, turn off the ultrasound system and any accessory equipment. Disconnect the stand from the PowerPark dock or unplug the power cord. For the PowerPark dock, disconnect it from its AC power.

6

Cleaning and disinfecting

2 Clean the stand module and PowerPark dock surfaces to remove any gel or debris. Use the following procedure: English

a Use either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. b Remove all gel and debris from the PowerPark components. 3 With a new wipe, clean all parts of the PowerPark components by wiping from the clean areas to the soiled areas. This method helps to avoid cross-contamination.

4 Allow the PowerPark components to air dry in a clean, well-ventilated space.

Deutsch

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.

Safety Español

For maximum safety, observe all of the warnings and cautions in this section. Please report any serious safety incident that occurs in relation to the PowerPark and the system to FUJIFILM Sonosite and to the competent authority of the country in which the user and patient are located.

Electrical safety Class I equipment

The PowerPark is classified as Class I equipment.

Non AP/APG

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

Français

Table 2: Electrical safety classification

Italiano Nederlands 한국어

Safety

7

WARNINGS 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. 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. 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.

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. Refer to the cleaners and disinfection tool available at www.sonosite.com/support/cleaners-disinfectants for a list of approved cleaners and disinfectants

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Safety

Hazardous materials English

WARNING Products and accessories may contain hazardous materials. When disposing of products and accessories, be environmentally responsible and meet federal and local regulations for disposing hazardous materials.

Electromagnetic compatibility (EMC) Deutsch

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 Español

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:

Français

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:

Italiano

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.

Nederlands

Ground yourself to discharge any static charge. Use a wrist strap to bond yourself to earth ground.

한국어

Safety

9

Labeling symbols The following symbols are used on the products, packaging, and containers.

Table 3: Standards labeling symbols Symbol

Title

Standards development Reference organization (SDO) number

Description

Manufacturer

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.1.1

Indicates the medical device manufacturer, as EU directives 90/385/EEC, 93/42/EEC and 98/79/EC

SN

Serial Number

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.1.7

Indicates the manufacturer’s serial number so that a specific medical device can be identified

REF

Catalog Number

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.1.6

Indicates the manufacturer’s catalogue number so that the medical device can be identified

Consult instructions for use

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.4.3

Indicates the need for the user to consult the instructions for use

10

Safety

Table 3: Standards labeling symbols Symbol

Description

ISO 7000 / IEC 60417 Graphical symbols for use on equipment

5032

Indicates on the rating plate, that the equipment is suitable for alternating current only, in order to identify appropriate terminals

Fragile handle with care

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.3.1

Indicates a medical device that can be broken or damaged if not handled carefully

Keep dry

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.3.4

Indicates a medical device that needs to be protected from moisture

Medical Device

EU MDR

EU MDR Annex I, 23.2 (q)

Indicates the item the label is adhered to is categorized as a medical device per the MDR, Annex 1, 23.2, q.

11

한국어

Alternating current

Nederlands

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons, be presented on the medical device itself

Italiano

5.4.4

Français

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

Español

Caution

Deutsch

Safety

Standards development Reference organization (SDO) number

English

MD

Title

Table 3: Standards labeling symbols Symbol

12

Title

Standards development Reference organization (SDO) number

Description

Temperature limit

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.3.7

Indicates the temperature limits to which the medical device can be safely exposed

Atmospheric pressure limitations

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.3.9

Indicates the range of atmospheric pressure to which the medical device can be safely exposed

Humidity limitation

ISO 15223-1 Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

5.3.8

Indicates the range of humidity to which the medical device can be safely exposed

Stacking limit by number

ISO 7000 Graphical symbols for use on equipment

2403

Do not stack over n high, where n represents the number on the label.

Corrugated recycle

-

-

Shipping box is made of corrugated cardboard and should be recycled accordingly

RESY – Recycling Symbol

-

-

Paper recycle

CE Marking

-

-

Signifies European Technical Conformity

Safety

Table 3: Standards labeling symbols Symbol

Title

Description English

Standards development Reference organization (SDO) number BS EN 50419 Marking of Electrical and Electronic Equipment in accordance with Directive 2012/19/EU for the Waste of Electrical and Electronic Equipment (WEEE) and Directive 2006/66/EC on Batteries and Accumulators and Waste Batteries and Accumulators

Annex IX

Do Not Throw in Trash

Canadian Standard Association Certification Mark

-

-

CSA certification mark signifying that the product complies with the applicable CSA and ANSI/UL requirements and is authorized for use in Canada and the US

Deutsch

Recycle: Electronic Equipment

European community authorized representative

ISO 15223-1 Medical devices symbols to be used with medical device labels, labeling and information to be supplied

5.1.2

Indicates the Authorized representative in the European Community

Nederlands

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.)

Italiano

1135

Français

ISO 7000 Graphical symbols for use on equipment

Español

China Pollution Control (10)

한국어

Safety

13

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, 8.0–3.3 A PowerPark Stand-Module Supply Input: 100–240 VAC, 50–60 Hz, 6.0–2.5 A

14

Specifications

English

Deutsch

Español

Français

Italiano Nederlands

한국어

15

Specifications

16

Specifications

96

Specificaties

P23655-02

*P23655-02*