Site-Rite Prevue and Site-Rite Prevue + System Technical Manual Rev Date Jan 2014

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System Technical Manual

Table of Contents Section 1

Statement of Purpose

2

System Overview

2.1 2.2 2.3

Controls and Connections Hardware Software

3

Mounting Hardware

4

Cleaning and Disinfection

5

Technical Specifications

6

Repair and Troubleshooting

7

Disposal Information

Table of Contents

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System Technical Manual

1

Statement of Purpose This Technical Manual is intended to provide technical specifications for the Site~Rite Prevue™ Ultrasound System and Site~Rite Prevue+™ Ultrasound System. For service requests, call Bard Access Systems’ Technical/Clinical Support at (800) 443-3385. Please refer to the IFU for all indications, contraindications, hazards, warnings, cautions, adverse events and indications for use.

2

System Overv iew

2.1

Controls and Connections The hardware is composed of user accessible features on the unit and ultrasound probe connection at the back.

2.1.1

Front/Side Panel

Figure 2.1.1 Front/Side Panel Press and hold the power button on the display for three seconds to turn the system on or off. The power LED indicates that the system is on when lit. Insert USB flash drive and A/C power adapter into designated ports on the ultrasound display as shown in Figure 2.1.1. Note:

In standby mode the system remains powered and battery life will be depleted. Standby mode allows the system to power up into ultrasound imaging more quickly than returning from a full shutdown.

Note: Holding the Power Button down for 8 seconds can be used to power the system down via a “Hard” shutdown. Powering the system down in this manner may cause system malfunction and should only be used when appropriate shutdown methods are unavailable.

Statement of Purpose / System Overview

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System Technical Manual

2.1.2

Back Panel

Figure 2.1.2 Back Panel Hold probe body for insertion/removal as shown in Figure 2.1.2. Do not pull the cable.

2.2

Hardware

System Overview

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System Technical Manual

2.2.1

Component Overview

Figure 2.2.1 Power System

The Ultrasound System is composed of several major components as depicted in Figure 2.2.1. See Table 2.2.1 for a functional description. Table 2.2.1 Major Components of the Ultrasound System Component

Functional Description

Location

Plastic Housing (Cycoloy Resin)

Contain parts, mechanical support, aesthetics

Exterior

Charging Circuitry

Power management and distribution, battery charging

Within plastic housing. Part of motherboard assembly.

USB Module

USB 2.0

Within plastic housing. Part of motherboard assembly.

Lithium Ion Battery

Power storage, charge status

Within plastic housing, rear enclosure.

Motherboard and Beamformer Platform

Processing, display data, provide user interface, application management

Within plastic housing

Power Button

On / off signal

Switch is directly mounted on the mother board assembly

Touch Screen

Resistive touch

Outermost layer of screen. Mounted on front enclosure.

Probe

52 element 7.5 MHz

PCB board to board connector to the beamformer assembly.

Component Overview

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2.2.2 System Hardware The software needs to interface to the beamformer hardware via USB 2.0 interface to receive the beam formed ultrasound data. The system also supplies power to the beamformer via an internal USB port. The beamformer electronics drive the ultrasound probe. The ultrasound system monitors and displays the remaining battery charge level as well as if the battery is actively charging. The external USB ports interface and power USB flash drives.

2.3

Software: The system runs on a Linux® based operating system. The software consists of an application, the resident platform operating system, and firmware to interface with the hardware. The application software may be updated by following the upgrade directions in the instruction for use.

3

Mounting Hardware

3.1

Tripod/Clamp Attachment

Step 1. Locate female attachment location

TRIPOD / CLAMP

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System Technical Manual

Step 2. Insert tripod and extend legs for proper balance

OR: Insert clamp and tighten vise for proper balance

TRIPOD / CLAMP

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Cleaning and Disinfection

4.1

Cleaning Procedure To clean the console, probe and A/C adapter: Note: When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices. Warning: Do not allow liquid to enter the system, A/C adapter, or connectors. Damage to the equipment may occur. Warning: Do not attempt to sterilize the System. Damage to the equipment may occur. Caution: Use only cleaning and disinfection procedures recommended by Bard Access Systems. Failure to do so may damage the device. 1. Turn off the system. 2. Dampen a nonabrasive cloth with either warm water or isopropyl alcohol. For a list of additional disinfectants recommended for use on the Site~Rite Prevue™ Ultrasound System and Site~Rite Prevue+™ Ultrasound System and probe, contact Bard Access Systems for the “Site~Rite™ Ultrasound System Compatible Disinfectants” document. (800) 545-0890 3. Gently wipe the dampened cloth over the exterior surfaces that require cleaning.

5

Technical Specifications

5.1

General Specifications

5.1.1

Operating and Storage Conditions

Operating Temperature:

50°F to 104°F (10°C to 40°C)

Storage Temperature:

0°F to 104°F (-18°C to 40°C)

Operating Humidity:

5% to 90% Relative Humidity (non-condensing)

Storage Humidity:

5% to 95% Relative Humidity (non-condensing)

Dimensions:

5.9” x 4.6” x 2.0” (149 x 117 x 52 mm)

Weight:

2 lbs (0.9 kg)

Power Sources:

Internal battery, AC adapter

Power Consumption:

45 Watts Max

IEC 60601-1:

Class II, Type BF Applied Part, Continuous Operation, Internally Powered Equipment, Not Category AP or APG Equipment, IPX1

Cleaning and Technical Specifications

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5.1.2

A/C Adapter Specifications

Manufacturer:

SINPRO

Model Number:

MPU60B-106

Input Voltage:

100-240 VAC, 50/60 Hz

Input Current (Max):

1.60A

Output Voltage:

15V

Output Current (Max):

4.2A

5.1.3

System Battery Specifications

Battery Chemistry:

Lithium Ion

System Run Time on Full Charge:

3.0 Hours

Charge Time (Full):

4.0 Hours

Technical Specifications

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System Technical Manual

5.2

EMC Tables The ultrasound system is intended for use in the electromagnetic environment specified below. The customer or user of the ultrasound system should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration - Emissions Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF Emissions CISPR 11

Group 1

The ultrasound system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The ultrasound system is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

RF Emissions CISPR 11

Class A

Harmonics IEC 61000-3-2

Class A

Flicker IEC 61000-3-3

Complies

Note: The ultrasound system is not classified to be used in a domestic enviroment. Caution: This system, with it applicable accessories, is intended for use by healthcare professionals only. If used in a domestic environment, this system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures such as re-orienting or relocating the ultrasound system or shielding the location.

EMC Tables

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Guidance and Manufacturer’s Declaration – Immunity The ultrasound system is intended for use in the electromagnetic environment specified below. The customer or user of the ultrasound system should ensure that it is used in such an environment. Immunity Test

EN/IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

ESD EN/IEC 61000-4-2

±6kV Contact ±8kV Air

±6kV Contact ±8kV Air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.

EFT EN/IEC 61000-4-4

±2kV Mains ±1kV Input/Output Lines

±2kV Mains ±1kV Input/Output Lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge EN/IEC 61000-4-5

±1kV Differential ±2kV Common

±1kV Differential ±2kV Common

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips/Dropout EN/IEC 61000-4-11

>95% Dip for 0.5 Cycle

>95% Dip for 0.5 Cycle

60% Dip for 5 Cycles

60% Dip for 5 Cycles

30% Dip for 25 Cycles

30% Dip for 25 Cycles

>95% Dip for 5 Seconds

>95% Dip for 5 Seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ultrasound system requires continued operation during power main interruptions, it is recommended that the ultrasound system be powered from an uninterruptible power supply or battery.

3 A/m

3 A/m

Power Frequency 50/60 Hz Magnetic Field EN/IEC 61000-4-8

EMC Tables

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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System Technical Manual

Guidance and Manufacturer’s Declaration – Emissions The ultrasound system is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ultrasound system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the ultrasound system as recommended below, according to the maximum output power of the communications equipment. Immunity Test

EN/IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF EN/IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

Portable and mobile communications equipment should be separated from the ultrasound system by no less than the distances calculated/ listed below:

Radiated RF EN/IEC 61000-4-3

3 V/m 3 V/m 80 MHz to 2.5 GHz

D = 1.2 (√ P) D = 1.2 ( √ P) 80 to 800 MHz D = 2.3 ( √ P) 800 MHz to 2.5 GHz where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels. Interference may occur in the vicinity of equipment containing a transmitter.

Recommended Separation Distances between portable and mobile RF Communications equipment and the ultrasound system

Max Output Power (Watts)

Separation (m) 150 kHz to 80 MHz D = 1.2( √ P)

Separation (m) 80 to 800 MHz D = 1.2 ( √ P)

Separation (m) 800 MHz to 2.5 GHz D =2.3( √ P)

0.01

.1166

.1166

.2333

0.1

.3689

.3689

.7378

1

1.1666

1.1666

2.3333

10

3.6893

3.6893

7.3786

100

11.6666

11.6666

23.3333

EMC Tables

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Repair and Troubleshooting There is no periodic or preventive maintenance required for the Site~Rite Prevue™ Ultrasound System or Site~Rite Prevue+™ Ultrasound System, probe or approved accessories. For service information or to return your ultrasound system for repair, please contact Bard Access Systems Technical / Clinical Support at (800) 545-0890. Warning: Only qualified personnel should attempt to service this equipment. The ultrasound system contains static sensitive components and circuits. Failure to observe proper static control procedures may result in damage to the system. Warning: Opening or servicing the system, probe, or A/C adapter by anyone other than Bard Access Systems Inc. authorized service personnel will void the warranty and may result in injury or equipment damage.

SYMPTOM

DESCRIPTION

SOLUTIONS

Error Code EC: 101 – 108

Ultrasound Hardware Failure

Reboot the System. Note: If error persists, call Customer Service at 1-800-545-0890.

Error Code EC: 201

Software Failure

Call Customer Service at 1-800-545-0890.

Error Code EC: 301

System temperature too high

Shut down the system and allow to cool. Note: If error persists, call Customer Service at 1-800-545-0890.

System plays a sound every minute

Low Battery

Connect system to an A/C outlet for operation and battery recharge.

Battery Error

Connect AC adapter for operation. Note: If error persists, Call Customer Service at 1-800-545-0890.

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Power Problem

System will not turn on or powers on but immediately turns off.

1. Connect system to an A/C outlet for operation and battery recharge. 2. Press and hold the power button for at least 3 seconds to power on. Note: If error persists, call Customer Service at 1-800-545-0890.

A/C adapter indicator does not change states

Connection error

1. Shutdown the system. 2. Unplug the A/C adapter and plug it back in. 3. Turn the system on. Note: If error persists, call Customer Service at 1-800-545-0890.

Can’t save an image

The USB Storage device may be full or not an approved USB Storage Device. Replace the USB Storage Device. Note: If error persists, call Customer Service at 1-800-545-0890.

Poor image

1. Refer to Image Settings, Section 5 of the Instructions for use. 2. Apply sterile saline to both surfaces of the Pinpoint* Gel Cap. 3. If error persists, call Customer Service at 1-800-545-0890.

Repair and Troubleshooting

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Disposal Information To return the ultrasound system for end of life recycling, please contact your nearest Bard sales or distributor office in the country of purchase. Note: Always properly dispose of dead battery packs in accordance with local regulations. Improper disposal may present an environmental hazard.

Manufacturer: Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 U.S.A. (801) 522-5000 Customer Service: (800) 545-0890 Technical/Clinical Support: (800) 443-3385 Fax: (801) 522-4948 www.bardaccess.com

An issued or revision date for these instructions is included for the user's information. In the event two years have elapsed between this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available. Revision date: January 2014 *Bard, Site~Rite, Site~Rite Prevue and Site~Rite Prevue+ are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © 2014 C. R. Bard, Inc. All rights reserved. 0731460 1401R

Disposal / Contact Information