Voluson Station User Manual Rev 3 Oct 2010

Revision history

Change of Company Name The company name of GE Medical Systems Kretztechnik GmbH & Co OHG will change. The new name becomes effective on November 1st, 2010. Please be advised that the new company name will replace the old company name wherever used in the manuals. New Company Name: GE Healthcare Austria GmbH & Co OG

4

Revision

Date

Revision 1

April 2009

Revision 2

May 2009

Revision 3

October 2010

Voluson® Station User Manual H48671ZD Revision 3

Table of Contents

Chapter 1 - Safety Safety Symbols and labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9 Symbols and Labels on the System - - - - - - - - - - - - - - - - - - - - - - - - 10 Important Instructions for Safety- - - - - - - - - - - - - - - - - - - - - - - - - - 16 Electric Installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19 Remarks for safe use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20 Patient Population- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 21 Safety Test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 21 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22

Chapter 2 - Voluson® Station Voluson® Station

Part description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 25 Setting up the Voluson® Station - - - - - - - - - - - - - - - - - - - - - - - - - - 30 Using the Voluson® Station - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 35 Probe Box - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 37 Patient monitor- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 38 Using peripheral devices with the Voluson® Station - - - - - - - - - - - - 41 Moving the Voluson® Station with mounted system - - - - - - - - - - - - 43

Chapter 3 - Technical Data & Maintenance Technical Data

Identification plate and labeling - - - - - - - - - - - - - - - - - - - - - - - - - - 48 Power Supply - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 49 Weight and Dimensions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 49 Environmental Conditions for Operation- - - - - - - - - - - - - - - - - - - - - 50 Inputs and Outputs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 50 Patient Monitor (optional) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 51 Maintenance and Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 51

Voluson® Station User Manual H48671ZD Revision 3

5

6

Voluson® Station User Manual H48671ZD Revision 3

Chapter 1 Safety Describes the safe handling of the Voluson® Station and the warning signs

Safety

1. Safety

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

The use of the system outside the described conditions or intended use, and disregarding safety related information is considered as abnormal use.

The screen graphics and illustrations in this manual are for illustrational purposes only and may be different from what you see on the screen or device.

8

Voluson® Station User Manual H48671ZD Revision 3

Symbols and labels 1.1 Symbols and labels Description of all symbols and labels used on the system and in the Basic User Manual.

1.1.1 Warning labels used in the Basic User Manual

Notice: Describes important information that has to be read before proceeding.

Caution: Describes general precautions necessary to protect health and equipment.

Electric Hazard: Describes precautions necessary to prevent the risk of injury through electric hazards.

Explosion Hazard: Describes precautions necessary to prevent the risk of injury through explosion hazards!

Mechanical Hazard: Describes precautions necessary to prevent the risk of injury through mechanical hazards.

Voluson® Station User Manual H48671ZD Revision 3

9

Safety 1.2 Symbols and Labels on the System Some symbols used with electrical medical equipment have been accepted as standard by IEC. They serve for marking connections, accessories and as warnings.

10

Mains power switch ON/OFF

This symbol indicates that in the United States of America, federal law restricts this device to sale by or on the order of a physician.

Consult accompanying documents. This symbol advises the reader to consult the accompanying documents.

Caution, consult accompanying documents. This symbol advises the reader to consult the accompanying documents for important safetyrelated information such as warnings and pre-cautions that cannot be presented on the device itself.

CE Conformity mark according to Medical Device Directive 93/42/EEC.

Tipping danger. Do not lean on the cart and take special care when moving. See ‘Moving the Voluson® Station with mounted system’ on page 43 for more information.

This symbol is followed by the serial number of the device.

This symbol is followed by the manufacturing date of the device in the form YYYY-MM.

Voluson® Station User Manual H48671ZD Revision 3

Symbols and Labels on the System This symbol is followed by the name and address of the manufacturer of the device.

NRTL Classification Label

This text indicates the voltages that the device is built for. Please note that either the first voltage range OR the second voltage (OR the third voltage range) is applicable – depending on your country’s voltage. This device uses alternating current. For actual voltage range used for your device see symbol to the right.

The voltage shown in this area, is the voltage actually required for the device (country specific). See also symbol to the left.

This indicates the maximum rated power consumption of the system.

This indicates the electrical frequency that the device is built for. Please note that either the first frequency OR the second frequency is applicable – depending on your country’s frequency.

Voluson® Station User Manual H48671ZD Revision 3

11

Safety This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display, contain mercury.)

12

Green dot on power cable plug

Indicates that the power cable is hospital grade. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital only” or “Hospital grade” Applicable depending on local regulatory requirements.

Indicates a connector that allows for output only

Indicates a connector that allows for input only

Indicates a USB connector

Indicates a VGA output connector

Indicates a network connector

Indicates a VGA input connector

Indicates a power connector for direct current

Indicates audio input and output connectors

Voluson® Station User Manual H48671ZD Revision 3

Symbols and Labels on the System

Indicates left and right audio output connector

Indicates a composite video connector

Indicates an S-Video connector

Indicates the selected Video Standard

Protective earth (ground) connection

Potential equilibrium connection

System passed the quality control (optional)

This table explains the properties of the different fuses.

Push this lever up, in order to unlock the height adjustment mechanism, then push or pull the upper part of the station up or down.

This label indicates a power output connector and describes its properties. The sum of the devices connected must not exceed 150VA.

All labels looking similar to the label on the left are a marker used during manufacturing and have no meaning relevant to the usage of the device.

This symbol indicates the power connector for the USB hub.

Voluson® Station User Manual H48671ZD Revision 3

13

Safety Patient Monitor: These symbols are used on the Patient Monitor User Interface: From left to right: Menu up Menu down Open/close menu Select/confirm Patient Monitor: 8" LCD-Monitor TNO: KTI301405 Model: MPM1 Typ (Type): PKM080M-D623 Spannung (Voltage): 12V DC Strom (Current): 650 mA Serien-Nr. (Serial-No.) :XX-XX-XXXXXXXX-XXX manufactured by creco gmbh www.creco-gmbh.de This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment according to local regulations.

14

Voluson® Station User Manual H48671ZD Revision 3

Symbols and Labels on the System

10 20

These symbols indicate that at least one of the six hazardous substances of the China RoHS Labelling Standard is above RoHS limitations. The number inside the circle is referred to as the Environmental Friendly Use Period (EFUP). It indicates number of years that the product, under normal use, will remain harmless to health of humans or the environment. EFUP = 10 for Short Use Products EFUP = 20 for Medium Use Products

Instructions for mounting and releasing the Voluson® i/e to/ from the Voluson® Station See ‘Mounting a system to the Voluson® Station’ on page 35 for more information.

Voluson® Station User Manual H48671ZD Revision 3

15

Safety 1.3 Important Instructions for Safety This equipment must not be used in the presence of inflammable gases (e.g. anesthetic gases) or in oxygen enriched environment.

• The leakage current of the entire system including any / all auxiliary equipment must not exceed the limit values as per EN60 601-1-1 (IEC 60601-1-1) resp. other valid national or international standards. • All equipment must comply with UL, CSA and IEC requirements. • In this case the only way to operate the system safely is to use an isolated signal link with minimum air clearance and creepage distance of the isolation device inagreement with IEC60601 incl. national deviations.

This cart is not an emergency device.

This equipment is not to be used in sterile environment.

This equipment is not to be used during transportation (e.g. ambulance cars, aircrafts).

Use care when handling and protect from damage also when not in use. DO NOT use a damaged or defective system. Failure to follow these precautions can result in serious injury and equipment damage.

Do not touch the patient and the Signal Input/Output lines at the same time.

16

Voluson® Station User Manual H48671ZD Revision 3

Important Instructions for Safety It is not allowed to remove covers or panels from the system. Only GE Healthcare-authorized personnel must perform service and repair tasks. Attempts of do-it-yourself repairs invalidate the warranty and are an infringement to regulations and inadmissible acc. to IEC 60601.

Disconnect mains from power supply to make device electroless.

Do not pour liquids onto the cart or the transformer.

Do not use with defibrillator. This equipment does not have a defibrillator approved applied part.

Adequate Ventilation for the transformer is required.

When a compact Voluson® ultrasound scanner is used with the cart, make sure the unit is firmly secured in the correct position on the cart otherwise it might become unstable and tip over.

The maximum load of a shelf is 6.5 kg (14.3 lbs).

Voluson® Station User Manual H48671ZD Revision 3

17

Safety Daily cleaning of the scanner, the probes and the probe holders from coupling gel, etc., is recommended; wet cloth and soap are allowed. Before cleaning the scanner switch off the mains power. Do not use disinfection spray nor gas disinfection. Electrical parts must be protected from drip water. Read all safety information located in your Voluson® i or Voluson® e Basic User Manual in chapter ’Safety’. This chapter contains information regarding: • Owner responsibility • Important safety considerations • Regulatory information • Standards used • Device labels and label icon description • Classifications • Acoustic Output • ALARA • System controls affecting acoustic power • Patient safety • Mechanical hazards • Electrical hazard • Personnel and equipment safety • Electrical safety • Allergic reactions to latex-containing medical devices • Electromagnetic compatibility (EMC)

18

Voluson® Station User Manual H48671ZD Revision 3

Electric Installation 1.4 Electric Installation The system has to be connected to a fully intact mains socket with a grounded guard wire via an appropriate mains cable. The ground wire must never be removed or disconnected.

The system must be exclusively installed in medically used rooms. The equipment conforms with regulations for electrical safety (IEC 60601) for use on human patients. Probes are rated Type BF. The minimum required house installation must have 10A.

It is not allowed to use an additional portable multiple-socket-outlet. Always use the power cords that are delivered with the system.

Before switching on the first time, the local mains voltage and frequency are to be checked against the values indicated on the cart nameplate on the rear panel. Only authorized personnel must perform any change to the system. Unauthorized modifications may result in hazardous situations.

Voluson® Station User Manual H48671ZD Revision 3

19

Safety 1.5 Remarks for safe use • • • •

•

• • •

• • • •

20

Follow these safety instructions as well as the clinically adopted precautions and measures for hygiene. The manufacturer is not liable for damage caused by improper or inexpert use of the device! The device is intended for indoor use in clinical environments such as hospitals and physician’s offices. A specialist acquainted with the handling and use of the system shall perform installation and first switch-on and check-up of the system. The user must have read and understood the user manual. The system must only be operated by trained and qualified personnel. The user manual must always be with the scanner system. It is the user’s duty to ensure this! Place the unit always on horizontal ground. Mains power quality should be that of a typical commercial and/or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptable power source (UPS) The cart has been tested for EMC and complies with IEC 60601. It is expected that the user has medical experience and is well informed with the user manual. Avoid kinking, bending or twisting of probe cables and take care to guard them against mechanical stress (e.g., wheels or heels). For safety reasons, avoid handling fluids in the vicinity of the system. Fluids leaking into the user interface can damage the cart.

Voluson® Station User Manual H48671ZD Revision 3

Patient Population 1.6 Patient Population • • • •

Age: no age limit Location: worldwide Sex: male and female Weight: all weight categories

1.7 Safety Test Visual inspection:

Housing, connection, operating elements, display facilities, labels, accessories, user manual.

Functional test:

Checking of functions (acc. to user manual), check also modular combinations and common operability of system and accessories.

Electric test:

Checking of the electric safety of system combinations acc. to VDE 0751 or respective national regulations. To perform electrical safety tests, follow instructions provided in the Voluson® i/e Basic Service Manual. For further instructions for care and maintenance of Voluson® i/e compact systems, see the respective user manual. Under the condition of regular maintenance by the authorized service personnel a lifetime of 7 years for the equipment and 5 years for the probes may be expected. Have the system checked and serviced in regular intervals (once per year) by authorized service personnel.

Voluson® Station User Manual H48671ZD Revision 3

21

Safety 1.8 Manufacturer Responsibility The manufacturer, assembler, importer or installer considers himself/herself responsible regarding safety, reliability and performance of the instrument under the following conditions: •

•

22

when assembling the system, when adding options, when new settings or modifications or repairs were performed by personnel authorized by him/her, also that the local electric installation complies to the national regulations, and that the equipment is only used according to the user manual.

Voluson® Station User Manual H48671ZD Revision 3