OptiVantage DH Operators Manual Rev A Dec 2004

0-Introduction

844960-A Dec. 2004

I-1

FOREWORD Congratulations on the purchase of your Liebel-Flarsheim OptiVantage® DH Injection System. The OptiVantage DH represents our effort to provide a quality product to support better health care throughout the world.

LIEBEL-FLARSHEIM TECHNICAL SUPPORT Phone No. 1-800-877-0791

RECORDING MODEL NUMBER, PART NUMBERS, AND SERIAL NUMBERS The model number (Mod. No.), part numbers (P/N), and serial numbers (S/N) must be supplied when requesting replacement parts or optional accessories. For convenience, record the requested information below: Power Supply Mod.No.

-

P/N

-

S/N Powerhead

CI

B

P/N S/N

CI

B

Console S/N P/N S/N Date of Installation

CI

B /

/

Installing Company _________________________________________ Address ___________________________________________________ Phone No. __________________________________________________ OptiVantage® is a registered trademark of the Liebel-Flarsheim Co. 844960-2 Sept 2004

I-Introduction

Regardless of how well equipment is designed, misuse or abuse will deny its owner the expected quality of service. Misuse or abuse may occur unintentionally because the proper method of operating the equipment is unknown. Read this manual carefully before operating the OptiVantage DH. Retain this manual for future reference.

I-2

MEANINGS OF SYMBOLS

I-Introduction

SYMBOLS LOCATED IN THE MANUAL Please regard any message that follows a Danger, Warning, or Caution symbol.

DANGER! DANGER!-Hazards which could result in severe personal injury or death.

WARNING! WARNING!-Hazards which could result in personal injury. CAUTION! CAUTION!-Hazards which could result in equipment or property damage.

844960-2 Sept 2004

I-3

SYMBOLS LOCATED ON THE POWER CONTROL Connection

Symbol

Definition Powerhead Cable Connector

J2

Startswitch Cable Connector

J3

Ethernet Port

J5

I-Introduction

J1

RS232/RS422 Port

RS232/ RS422

J6

Universal Interface Connector

J10A

Console Cable Connector TM

J10B

P4

OptiBolus™ Console Cable Connector

CAN

Controller Area Network Port Equipment sensitive to Electrostatic Discharge. DO NOT TOUCH exposed connectors.

!

ATTENTION! Consult User's/Service Manual. CAUTION! Risk of electrical shock. Do not remove cover. Refer servicing to qualified personnel.

250 V 4 AMP SLO-BLO

Controller Area Network Port

Mod. No.

Model Number

S/N

Serial Number

P/N

Part Number

V/A

Volts Amps

844960-2 Sept 2004

I-4

SYMBOLS LOCATED ON THE CONSOLE Connection

Symbol

Definition

I-Introduction

Push Push ON/OFF ANG

IOM

AT ILLU

MEN

J1

A

J2

Power Control Cable Connector Handswitch Cable Connector Console classified IEC 601-1, Type B

SYMBOLS LOCATED ON THE POWERHEAD

Connection

Symbol

Definition Manual Knob Light Status Flashing Blue: Injector Powering Up Solid Purple/Yellow: Enabled or injecting contrast (purple) or saline (yellow) Flashing Yellow: Drip Mode injecting saline Flashing Purple and Yellow: Injector Paused Flashing Red: Alarm condition Flashing Purple quickly: Injector rotated vertically or 30 degrees below horizontal. Heater Blanket Cable Connector

Powerhead classified IEC 601-1, Type CF

844960-2 Sept 2004

I-5

CLASSIFICATION IN ACCORDANCE WITH EN 60601-1 TYPE OF PROTECTION AGAINST ELECTRIC SHOCK Class I equipment I-Introduction

DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK Type CF applied part. DEGREE OF PROTECTION AGAINST INGRESS OF WATER Ordinary Equipment

OptiVantage

C

SSIFIE

LA

SSIFIE

D

LA

D

C

UL/CSA CLASSIFICATION

UL 2601-1

®

33SL

C

®

OptiVantage™ DH Injection System CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1 33SL OptiVantage™ DH Injection System CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/ CSA C22.2 NO. 601.1, 33SL

CE MARK INFORMATION

Conforms to the European Medical Device Directive (MDD) 0123

844960-2 Sept 2004

I-Introduction

I-6

This manual originally written in English.

Copyright © 2004 by Liebel-Flarsheim, Inc., All Rights Reserved. All software used with this device and its related documentation (“Software”) are owned by Liebel-Flarsheim, Inc. The Software was designed specifically for this device and may not be used with any other device or for any other purpose. The Software is protected by United States and International Copyright Laws. The Software may not be copied, modified, or adapted for any other use without express written permission from Liebel-Flarsheim. The Software code is a trade secret of Liebel-Flarsheim. The Software code may not be reverse engineered, decompiled, disassembled or otherwise discovered. 844960-2 Sept 2004

i

Table Of Contents REVISIONS ... 2 Recording Model Number, Part Numbers, and Serial Numbers ... I-1 Meanings of Symbols... I-2 Symbols Located in the Manual ... I-2 Symbols Located on the Power Control ... I-3 Symbols Located on the Console ... I-4 Symbols Located on the Powerhead ... I-4 Classification in accordance with EN 60601-1 ... I-5 Type of protection against electric shock ... I-5 Degree of protection against electric shock... I-5 Degree of protection against ingress of water ... I-5 UL/CSA Classification ... I-5 CE Mark Information ... I-5

844960-2 Sept 2004

0-Introduction

Foreword ... I-1

ii

SYSTEM OVERVIEW ...1-1-1 1.1 Indications for Use ...1-1-2 1.2 User Qualification...1-2-1

0-Introduction

1.3 System Features ... 1-3-1 1.3.1 Versatility ... 1-3-1 1.3.2 Touch-Screen Displays ...1-3-1 1.3.3 Protocol Memory With Password Protection ... 1-3-1 1.4 Safety Features ... 1-4-1 1.4.1 Self-testing Design ...1-4-1 1.4.2 Electrically Isolated Syringe ...1-4-1 1.4.3 Syringe Clarity ...1-4-1 1.4.4 Positive Positioning of the Powerhead ...1-4-1 1.4.5 Physical Stability ... 1-4-1 1.4.6 Pointing Powerhead Downward prior to Starting an Injection ... 1-4-1 1.4.7 Air Embolism Hazard Check...1-4-2 1.4.8 Start/Stop Key on Powerhead ...1-4-2 1.4.9 Remote Control Operation ...1-4-2 1.5 Specifications ...1-5-1 1.5.1 Dimensions ...1-5-1 1.5.2 Weight ... 1-5-1 1.5.3 Power Requirements ...1-5-1 1.5.4 Voltage Requirements ...1-5-1 1.5.5 Electrical Leakage ... 1-5-1 1.5.6 Environmental ...1-5-2 1.5.7 Syringe Sizes ...1-5-3 1.5.8 Syringe Heater ...1-5-3 1.5.9 Flow Rate ...1-5-3 1.5.10 Pressure ...1-5-3 1.5.11 Phase Delay ...1-5-3 1.5.12 Inject Delay ...1-5-3 1.5.13 Scan Delay ...1-5-3 1.5.14 Total Time ...1-5-4 1.5.15 Stored Protocols ... 1-5-4

844960-2 Sept 2004

iii

1.6 Consumables ...1-6-1 1.6.1 Syringes ...1-6-1 1.6.2 Low Pressure Tubing ...1-6-1 1.6.3 Catheters, Connectors and Tubing ...1-6-2

POWER ON/POWER OFF ...2-1-1 2.1 Turning the System Power ON ...2-1-1 2.2 Turning the System Power OFF ...2-1-1 CONSOLE AND POWERHEAD INTERFACES ...3-1-1 3.1 Console Interfaces ...3-1-3 3.1.1 Indicators ...3-1-3 3.1.2 Modes of Operation ...3-1-3 3.1.3 Main Screen Parameters and Symbols ...3-1-4 3.1.4 Memory Screen Parameters and Symbols ... 3-1-7 3.1.5 Setup Screen Parameters and Symbols ...3-1-8 Parameters ...3-1-8 Time/Date ...3-1-12 Language ...3-1-13 3.1.6 Results Screen Parameters and Symbols ...3-1-14 3.2 Powerhead Interfaces ...3-2-1 3.2.1 Fill/Expel Arrows ...3-2-2 3.2.2 Manual Knobs ...3-2-3 Description...3-2-3 Light Status...3-2-3 3.2.3 Heater Blanket Connection ...3-2-4 3.2.4 Display ...3-2-5 Main Screen Parameters and Symbols ...3-2-7 Protocol Parameter Entry Screen ...3-2-9 Memory Screen Keys and Definitions ...3-2-11 Results Screen Parameters and Symbols ...3-2-11

844960-2 Sept 2004

0-Introduction

1.7 Accessories ...1-7-1

iv

PROGRAMMING PARAMETERS ...4-1-1 4.1 Programming Protocols ...4-1-1 4.1.1 Entering Numeric Parameters ... 4-1-1

0-Introduction

Console ...4-1-1 Powerhead ...4-1-2 4.1.2 Selecting the Side ... 4-1-4 4.1.3 Programming a Timing Bolus Protocol ...4-1-4 4.1.4 Programming a Drip Mode Injection ... 4-1-4 4.1.5 Programming an OptiBolus Injection ...4-1-6 4.2 Protocol Memory Management ...4-2-1 4.2.1 Storing a Protocol in Memory ...4-2-1 4.2.2 Recalling a Protocol ... 4-2-1 From the Powerhead ...4-2-1 From the Console ... 4-2-1 4.2.3 Deleting a Protocol ...4-2-2 4.2.4 Renaming a Protocol ... 4-2-2

844960-2 Sept 2004

v

DELIVERING AN INJECTION ...5-1-1 5.1 Enabling Sequence ... 5-1-1 5.1.1 Types of Injections ...5-1-1 5.1.2 Load Syringe(s) ... 5-1-2 Load 200 mL Syringe (A-side Only) ...5-1-5 Load 125 mL/200 mL Syringe ...5-1-7 Load 200 mL/200 mL Syringe ...5-1-10 5.1.3 Fill Syringe (200 mL Only) ...5-1-11 Auto Fill Technique... 5-1-11 Manual Fill Technique ...5-1-13 5.1.4 Attach Tubing to Syringe...5-1-14 5.1.5 Purge Air/Prime Tubing ...5-1-14 Purge Air 125 mL Prefill Syringe ...5-1-14 Purge Air 200 mL Disposable Syringe ...5-1-15 Prime Tubing with Saline ...5-1-15 5.1.6 Recall/Enter Protocol Parameters ...5-1-15 5.1.7 Connect to Patient ...5-1-15 5.1.8 Enable Injector ...5-1-16 5.1.9 Check Patency of I.V. Site ...5-1-16 Using the [Patency] key ...5-1-17 Using the Manual Knob ...5-1-18 5.2 Delivering an Injection ...5-2-1 5.2.1 Dangers/Warnings/Cautions...5-2-1 5.2.2 Starting The Drip Injection ...5-2-2 5.2.3 Starting the Main Injection ...5-2-2 5.2.4 Changing the Flow Rate During an Injection ... 5-2-2 5.2.5 Pausing an Injection ...5-2-2 5.2.6 Restarting a Paused Injection ...5-2-3 5.2.7 Displaying Results Screen...5-2-3 5.2.8 Terminating an Injection...5-2-3

844960-2 Sept 2004

0-Introduction

Load 125 mL Syringe (A-side Only) ...5-1-3

vi

SYSTEM GENERATED MESSAGES ...6-1-1 6.1 Operator Messages ... 6-1-2 6.1.1 Programming Messages...6-1-2 Automatic Prefill Syringe Size Sensor ...6-1-2 0-Introduction

Heater Blanket ...6-1-2 Insert Syringe SIDE A ...6-1-2 Insert Syringe SIDE B ...6-1-3 OEM Interface Connection ...6-1-3 Programmed to Deliver more than 125 mL ...6-1-3 Programmed to Deliver more than 200 mL ...6-1-4 Unreadable Data on Powerhead or Display ...6-1-4 6.1.2 Auto Fill Messages ...6-1-5 Rotate Powerhead ...6-1-5 6.1.3 Enable Process Messages ...6-1-6 125 ml Purge Sequence not completed ... 6-1-6 200 mL Fill Sequence not completed ...6-1-6 Handswitch is closed. ...6-1-7 Rotate Powerhead Down ... 6-1-7 Used Syringe ...6-1-7 6.1.5 Injector Disabled Messages ...6-1-8 Drip Expired ...6-1-8 Injector Stalled ...6-1-8 Insufficient Volume ...6-1-8 Pressure Limited ...6-1-8 Syringe Clamp Open. ... 6-1-9 6.1.6 Achieved Values Messages ...6-1-9 Pressure Limited ...6-1-9 6.2 Fault Messages ...6-2-1 Console PIC detected a fault. ...6-2-1

844960-2 Sept 2004

vii

CARE OF UNIT ...7-1-1 7.1 Daily Inspection ... 7-1-1 7.1.1 200 ml Pressure Sleeve ...7-1-1 7.2 Cleaning ...7-2-1 7.2.2 Console ...7-2-1 7.2.3 Power supply ...7-2-1 7.3 Replacing the Pressure Sleeve ...7-3-1 7.3.1 Removing/Replacing the 200 ml Pressure Sleeve ...7-3-1

844960-2 Sept 2004

0-Introduction

7.2.1 200 ml Pressure Sleeve and Base ...7-2-1

0-Introduction

viii

844960-2 Sept 2004

1-1-1

SYSTEM OVERVIEW

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1-Overview of the OptiVantage DH

A

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A: 125 B:

125

121 ml

121

Phase

Side

PH1

:

PH2

:

PH4

:

PH5

A

B -

:

ml Flow ml/sec

1.5 5.5

Volum e ml

Check for air syring in e and tubing

LIVE Durati

R

on sec 70 46 23

Total Time

4

PH6

Inject

:

258 Delay

0:00 Scan

Delay

30 Peak

300

Memo

ry Setup

PSI

Enabl

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Resul

ts

Main

Figure 1-1-1 OptiVantage DH Injection System

844960-A Dec. 2004

1-1-2 1.1 INDICATIONS FOR USE

1-Overview of the OptiVantage DH

The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient’s vascular system to obtain diagnostic images when used with computed tomography (i.e. “CT”) equipment.

844960-A Dec. 2004

1-2-1 1.2 USER QUALIFICATION The OptiVantage Injection System should be operated ONLY by qualified personnel who: • are completely familiar with the unit,

• have been trained concerning the process of how to stop an injection in the case of an emergency (described in Chapter 5 of this manual), and • are otherwise properly trained in the use of equipment and procedures of this type. Failure to follow these guidelines could result in serious injury to the patient or the operator.

CAUTION! Federal law restricts this device to sale by or on the order of a physician.

844960-A Dec. 2004

1-Overview of the OptiVantage DH

• have read and understood this Operator's Manual,

1-Overview of the OptiVantage DH

1-2-2

844960-A Dec. 2004