VeinViewer Vision Field Service Guide

Quick Reference Tips for

Use Vision’s exclusive ASSESSTM Imaging Suite to find the optimal vessel while keeping your Eyes On Patient.TM

Powering (Chapter 4, Page 18) • Power up the unit by flipping the Projector Power Switch located on the Battery Cover to

the “On” position. • Press the On/Standby button located on the Control Panel to preserve battery life when not in use.

Focusing (Chapter 4, Page 20) • The proper focal distance from the Head Unit to the assessment area is 13 inches (33cm).

There is a 1-inch focal window in either direction. • Position the Head Unit as close to perpendicular (90°) as possible with the assessment area. • Placing the Head Unit close to the patient skin, move away until the border text becomes legible.

Imaging (Chapter 4, Page 22) • Once in focus, choose the desired imaging mode by pressing the Mode button:

- Universal - baseline imaging mode for all patients. - Fine Detail - adjusts contrast to view finer detail. Helpful for pediatrics, neonates or sclerotherapy patients. • Size - adjusts the image window to three different sizes. • Inverse - inverts the colors within the image field to project green veins on a dark background. For further assistance with VeinViewer®, refer to the Troubleshooting section (Chapter 6) of this User Guide. Or call Christie Medical Holdings, Inc. Customer Service at 1-877-SEE-VEIN (1-877-733-8346) toll-free (+01-901-252-3700 international), or e-mail [email protected].

V E IN V IE WER VI S I O N US ER GUI D E

TABLE OF CONTENTS

CHAPTER ONE: INTRODUCTION...3 Conventions Used... 3 Safety... 3 ELECTRICAL Safety... 4 EQUIPMENT Safety... 5 RISK ANALYSIS... 6 Intended Use... 6 Symbol Definitions... 7 CHAPTER TWO: PRODUCT DESCRIPTION...8 Detachable Parts... 8 SOFTWARE VERSION... 8 ® VeinViewer Unit: Front view... 9 VeinViewer Unit: back view... 10 Control Panel... 12 imaging field... 13 CHAPTER THREE: GETTING STARTED ...14 MOVING VEINVIEWER... 14 MOVING PROCEDURE... 15 CHAPTER FOUR: OPERATING INSTRUCTIONS...17 Powering VeinViewer... 17 POWERING PROCEDURE... 18 OPERATING BY AC and battery POWER... 18 FOCUSING procedure... 20 Actual size reference image... 21 IMAGING... 22 CHAPTER FIVE: MAINTENANCE...24 CLEANINg... 24 SYSTEM PROCEDURES... 25 SYSTEM SURFACES... 25 VEINVIEWER LENS... 25 battery care... 26 installing and removing battery... 27

V E I N V I E W E R V I SION FIE L D SE RVIC E GUID E

TABLE OF CONTENTS (CONTINUED)

CHAPTER SIX: SERVICING VEINVIEWER ...28 TOOLS... 28 TROUBLESHOOTING... 29 HEAD... 32 POWER SUPPLY... 36 INTERFACE CABLE... 40 head pivot JOINT... 47 upper joint... 51 WHEELS... 55 LOCKING PIN REMOVAL... 58 CHAPTER SEVEN: SERVICEABILITY ...63 CHAPTER EIGHT: TECHNICAL SPECIFICATIONS ...64 INTERFERENCE... 69 EQUIPMENT CLASSIFICATION... 71 PATENTS... 71 CHAPTER NINE: LIMITED WARRANTY ...72 CHAPTER TEN: PREVENTATIVE MAINTENANCE ...73 NOTES ...74

VE I N V I E W E R V I SION FIEL D SE RVIC E GUID E

CHAPTER ONE: INTRODUCTION

Please carefully read the information in this User Guide in its entirety and review these materials periodically to ensure that you will ® be able to use VeinViewer Vision confidently and correctly. This User Guide is a reference for using ® VeinViewer . It does not provide training in venous identification or clinical practices. The User Guide covers the preparation and use of VeinViewer and includes a Table of Contents to help you find the information you need. If additional information is needed, contact Christie Medical Holdings at www.veinviewer.com, e-mail info@ veinviewer.com or call the VeinViewer Support Center toll-free at 1-877-SEEVEIN (1-877-733-8346). For international calls, dial +01-901-252-3700.

! CAUTION • Please read through all cautions and warnings prior to moving or operating VeinViewer. • Read and review all instructions in this User Guide prior to using VeinViewer. • Federal (USA) law restricts this device to sale by, or on the order of, a physician/healthcare professional.

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

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Conventions Used

! WARNING

3

Indicates a potentially hazardous situation which, if not avoided, could result in serious injury or loss of life.

! CAUTION Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury or damage.

note: • Describes a situation with potential errors in procedure. • Numeric steps indicate references for parts identification or procedural instructions, which must be performed in a specific order. • Bulleted lists indicate information provided in list format, but they do not indicate a sequence of events.

C H A PT E R ON E : I N TRODUCTION

CHAPTER one: Introduction

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SAFETY

electrical safety

Observe the following safety precautions to obtain maximum personal safety and to protect your ® VeinViewer .

Cord-connected equipment employing “Hospital Only” or “Hospital Grade” attachment is provided with instructions to indicate that the grounding reliability can be achieved only when the equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.” The necessary instructions will be included on the equipment itself or on a tag attached to the Power Cord of the equipment.

VeinViewer produces a bright light; however, it does not use a laser-based illumination system.

! CAUTION • Do not look directly into the imaging light source when the Head Unit power is on. • Due to the bright light output, use proper eye protection when imaging vasculature around the eyes. Refer to your institution’s guidelines concerning ocular safety procedures. • VeinViewer should be powered off and unplugged from the AC outlet after a power failure. Turn Unit off for 20 seconds, and then back on again. • The Power Cord acts as a MAINS disconnect device.

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

Note: The VeinViewer product is shipped with a detachable Power Cord and a removable Battery inside the container. The Power Cord supplied herein is compliant for North American use. For destinations other than North America, the distributor country or sales representative in the destination country is required to provide the appropriate, detachable medical-grade Power Cord. This medicalgrade cord must be compliant with both the destination country’s power requirements, and the electrical requirements specified in the User Guide.

CHAPTER ONE: INTRODUCTION

CHAPTER ONE: INTRODUCTION

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equipment safety

! WARNING

! CAUTION

• Do not power on the Unit if there is any visible damage. • Do not place, hang, or otherwise apply weight to the Unit Arm. ® • Do not attempt to lift the VeinViewer in any way. • Always put the Head Unit in the travel position before moving. • Do not expose VeinViewer to excessive moisture, temperature, or direct energy sources such as heat lamps.

• Do not touch, strike, or otherwise damage the glass lens of the Head Unit.

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

Note: Cleaning methods listed are recommended for compatibility with Unit materials. Use cleaning methods in accordance with your individual institution’s infection control guidelines.

CHAPTER ONE: INTRODUCTION

CHAPTER one: introduction

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Risk Analysis

Intended Use

There are no known long-term risks associated with use of VeinViewer®.

VeinViewer is a non-invasive electronic visual aid device designed to project an image of superficial subcutaneous vascular structures on the surface of the skin.

• As VeinViewer projects a bright light, the operator must instruct patients not to look or stare directly into the VeinViewer imaging light source. • VeinViewer does not contain light sources with enough intensity to cause body heating or skin damage with prolonged use.

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VeinViewer is not intended to enable direct or indirect medical procedures. VeinViewer is not intended to be used to diagnose or verify the presence of a medical condition. It is not to be used outside or near outside windows. VeinViewer is not intended to be used near equipment that may emit strong magnetic fields (i.e., MRI equipment). It is not intended to be used for imaging of veins in the eyes, in tissue differentiation, as a diagnostic device or as a form of treatment.

CHAPTER ONE: INTRODUCTION

CHAPTER ONE: INTRODUCTION

Symbol Definitions

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SN

Caution: Consult accompanying documents

SN

Date of manufacture

I 0

Caution: Risk of electrical shock

On/Off system power switch

On/Standby

Manufacturer

SN SN SN

SN SN

EC

SN: Serial Number

EC

Protective Earth

REP

Authorized representative in the European community

Transport symbol

Consult instructions for use Battery symbol

SN

Equipotential

EC

EC EC

REP

REP REP

EC

REP

EC

REP

EC

REP

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

CHAPTER ONE: INTRODUCTION

CHAPTER Two: Product Description

VeinViewer® is designed for ease of use. VeinViewer utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure directly onto a patient’s skin. AVINTM (Active Vascular Imaging Navigation) allows the user to assess multiple access points with a real-time digital image. The adjustable head can be positioned over any part of the anatomy, leaving the clinician’s hands free through our trademarked EOPTM (Eyes On Patient) technique.

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Detachable Parts • Power Cord • Battery software version The VeinViewer software version is displayed by simultaneously pressing the Mode button and the Size button located on the control panel.

Controls, indicators, and receptacles are illustrated and described in this section.

! CAUTION Please refer to statement of Intended Use on page 6. To exit the Software Version Screen press the Mode button.

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER Two: Product Description

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®

VeinViewer Unit: Front View 1

Control Panel: Location of unit imaging and feature controls.

2

Head Unit: Controls VeinViewer imaging and user functions located in the Head Unit Control Panel.

3

Head Pivot Joint: Enables user to position the Head Unit by rotating through 6 degrees of motion.

4

Arm: Enables the user to extend the Head Unit vertically to the desired location.

5

Upper Joint: Allows user to move the Arm vertically.

6

Lower Joint: Allows user to move the Arm horizontally.

7

Post: Supports the Yoke of the Unit and Unit accessories.

8

Cable Holder: Provides storage of the User Guide and Power Cord when not in use.

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5 2 1

4 3 6 7

8

9

Power Cord: Conducts power to Unit through insertion into a properly grounded receptacle.

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER Two: Product Description

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VeinViewer® Unit: BACK View 10 Battery Cover: Location of the Projector

Power Switch.

11 Projector Power Switch: Allows the user to

toggle the VeinViewer power between “On” and “Off” mode.

12 Base 13 Wheel: Enables transport of VeinViewer.

The Wheel Lock allows the user to lock the Wheel in order to halt movement of the Unit.

10 11

12 13

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER Two: Product Description

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VeinViewer® Unit: BACK View (CONTINUED) 15 Yoke: Supports the Arm and Head Unit. 16 Interface Cable: Delivers power to the Head Unit. 17 Battery Case: Protects the Battery. Location of the

Power Inlet and Ground Stud.

18 Power Inlet: Connects to the Power Cord for

conducting power to the Unit.

19 Ground Stud: For biomedical department testing.

15

16

18 17

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER Two: Product Description

CONTROL PANEL 1

On/Standby: Toggles the Head Unit between “On” and “Standby” Modes. The Indicator illuminates when power is supplied and the Head Unit is turned on.

2

Mode: Toggles between the Universal and Fine Detail Modes.

3

Inverse: Inverts the colors within the image field to project green veins on a dark background.

4

Size: Adjusts the size of the projected image field.

5

Battery Indicator: Alerts the user to the charge level of the Battery. Illuminates solid red when the Battery charge level is at 25%. The indicator blinks red when the Battery charge level reaches 10%.

12

w

1

4

5

2

3

NOTE: The Mode and Size buttons access the Device Information screen when pressed simultaneously.

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER TWO: PRODUCT DESCRIPTION

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IMAGING FIELD NOTE: Wall Power Icon appears when Unit is plugged into wall. Inverse Mode Icon

Current Mode Current Mode Product Name Product Name

Inverse Mode Icon Battery Charge Level

Wall Power Icon Wall Power Icon

Company Name

Company Name

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CHAPTER TWO: PRODUCT DESCRIPTION

CHAPTER Three: Getting Started

Moving VeinViewer® Follow the procedure on next page to prepare VeinViewer for moving from location to location.

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! CAUTION • Do not stand on the Base of VeinViewer.

! WARNING Before attempting to move VeinViewer, make sure it is not plugged into any receptacle and the Power Cord is wrapped around the Cable Holder.

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CHAPTER THREE: GETTING STARTED

CHAPTER Three: Getting Started

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moving Procedure 1

2

w

Center the Yoke so that it is in line with the Post. Ensure that the Head Unit is in line with the Arm, and fold the Arm against the Post. Move the lever upward on all Wheel locks to unlock the Wheels. All Wheels should turn freely and smoothly.

w

2

3 Holding the Post below the Lower Joint

move VeinViewer to the desired location. 3

1

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CHAPTER THREE: GETTING STARTED

CHAPTER Three: Getting Started

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moving Procedure (CONTINUED) w

4

Raise the Arm to the desired height. NOTE: When VeinViewer® is not in use, ensure Unit is in traveling position (Arm folded down, Head Aligned with Arm).

4

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

CHAPTER THREE: GETTING STARTED

CHAPTER Four: Operating Instructions

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Powering VeinViewer ® The Projector Power Switch is located on the VeinViewer Battery Cover. The Unit is off when the Projector Power Switch is in the off position and the Unit is unplugged. If the Projector Power Switch is off and the Unit is plugged into a power outlet, the system is charging.

! WARNING • To avoid the risk of electrical shock, the plug must be inserted into receptacles marked “Hospital Grade” or “Hospital Only.” The Protective Earth wire must not be removed or defeated. • The Power Cord acts as the MAINS disconnect device. • To avoid the risk of electrical shock and fire hazard, inspect the Power Cord and plug on a regular basis. If they are damaged in any way, contact Christie Medical Holdings at www.veinviewer.com, e-mail [email protected], or call the VeinViewer Support Center toll-free at 1-877-SEE-VEIN for repair or replacement. For international calls, dial +01-901-252-3700.

! CAUTION Ensure the Projector Power Switch is in the off position before inserting the plug into the wall receptacle.

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

CHAPTER FOUR: OPERATING INSTRUCTIONS

CHAPTER Four: Operating Instructions

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powering procedure w

The VeinViewer® Vision Battery comes partially charged and should be immediately ready for training purposes. It is recommended that you charge VeinViewer overnight before beginning regular continued use.

w

VeinViewer may be operated by AC (electrical outlet) or battery power. Operating by AC and battery Power: 1

Unwrap the Power Cord from the Cable Holder, insert the receiver power plug into the port located at the back of the Base of the Battery Case, and insert the pronged plug into a properly grounded electrical outlet.

1 2

If operating by battery power, skip step 1. 2

Press the top of the black Projector Power Switch (symbol 1) located on the Battery Cover. The VeinViewer image will project in Universal mode.

V E IN V IEW E R VI S I O N F I E L D S E R VI C E GU I DE

CHAPTER FOUR: OPERATING INSTRUCTIONS