OptiStar Elite Operators Manual May 2017

I-INTRODUCTION

ii

CONTACT INFORMATION Liebel-Flarsheim Company LLC 1034 S Brentwood Blvd. Suite 800 Richmond Heights, MO 63117 1-314-376-4901 1-855-266-4944 [email protected] ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________

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iii FOREWORD

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 OptiStar Elite MR Contrast Delivery System. Retain this manual for future reference.

RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS The reference number (Ref. No.) and serial numbers (S/N) must be supplied when requesting replacement parts or optional accessories. For convenience, record the requested information below:

Ref. No. ________________________________(located on Power control) Power Control S/N ___________________________ Powerhead S/N

___________________________

Console S/N

___________________________

Power Supply S/N

___________________________

Date of Installation

/

/

Installing Company___________________________________________ Address_____________________________________________________ Phone No. ___________________________________________________ Software version numbers may be accessed via the System Info key on the Results screen Console_____________________________________________________ Powerpack___________________________________________________

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I-INTRODUCTION

Congratulations on the purchase of your OptiStar® Elite MR Contrast Delivery System. The OptiStar Elite MR Contrast Delivery System represents our effort to provide a quality product to support better health care throughout the world.

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I-INTRODUCTION

PATENT INFORMATION U.S. patents protecting this product are listed at this website: www.guerbet.com/patents

MEANINGS OF SYMBOLS USED IN THIS MANUAL Please regard any message that follows the word Danger, Warning or Caution!

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

WARNING! Hazards which could result in personal injury.

CAUTION! Hazards which could result in equipment or property damage.

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v MEANINGS OF SYMBOLS USED ON THE INJECTOR I-INTRODUCTION

Symbol

Definition Console Connection identifier

Powerhead Connection identifier

Power Control identifier

Power Supply identifier

Hand start switch connection identifier System OFF/ON (only for the Console) Power OFF/ON Ram movement/injector status identifier: A-side Light and B-side Light OFF = Injector Disabled A-side Light and B-side Light ON = Injector Enabled A-side Light ON ; B-side Light Flashing = Patency Check Ready A-side Light Flashing ; B-side Light OFF = A-side Ram moving A-side Light OFF ; B-side Light Flashing = B-side Ram moving Check to ensure air is removed from syringe and tubing before injecting. Start Injection

P

Start Patency Check Injection Stop Injection Fluid Detect Pinch Point possible. Keep fingers away from this area. Refer to instruction manual / booklet

(01) 1074619000XXXX (21) 123ABCdefG

UDI (Unique Device Identification) located on rating label

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I-INTRODUCTION

Symbol

Definition Equipment sensitive to Electrostatic Discharge. DO NOT TOUCH exposed connectors.

MR

MR Unsafe--an item that is known to pose hazards in all MR environments.

MR

MR Conditional--an item that has been demonstrated to pose no know hazards in a specified MR environment with specified conditions of use.

MR

MR Safe--an item that poses no known hazards in all MR environments.

<300G

Locate in an area with magneticfields less than or equal to 300 Gauss.

!

ATTENTION! Consult User's/Service Manual. European Union’s Waste Electrical and Electric Equipment (WEEE). CAUTION! Risk of electrical shock. Do not remove cover. Refer servicing to qualified personnel.

T 4AH , 250 V

Fuse Rating (Voltage, Amperage, Type)

REF

Reference

S/N

Serial Number

P/N

Part Number

V/A

Volts Amps [Reverse] key. Retracts the Powerhead Ram. [Accelerator] key. Increases the speed of the ram when held down with [Forward] or [Reverse] key. [Forward] key. Advances the Powerhead Ram.

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vii CLASSIFICATION IN ACCORDANCE WITH EN60601 I-INTRODUCTION

TYPE OF PROTECTION AGAINST ELECTRIC SHOCK Class I equipment DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK Type CF applied part (Syringes and Tubing) DEGREE OF PROTECTION AGAINST INGRESS OF WATER Ordinary equipment DEGREE OF SAFETY OF APPLICATION IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. EMISSION STANDARD The OptiStar Elite MR Contrast Delivery System meets emission standard EN60601-1-2 Class B

UL/CSA CLASSIFICATION

33SL

OPTISTAR® ELITE MR CONTRAST DELIVERY SYSTEM (MEDICAL EQUIPMENT) WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 60601-1:2005, CAN/CSA-C22.2 No. 60601-1 (2008), IEC 60601-1:2005, UL 60601-1, IEC 60601-1:1998, A1:1991, A2:1995

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CE MARK INFORMATION

0123 GUERBET BP 57400 95943 Roissy CdG Cedex France (located at : 15 rue des Vanesses, 93420 Villepinte, France) Liebel-Flarsheim Company LLC, 2111 E. Galbraith Road, Cincinnati, OH 45237

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ix TABLE OF CONTENTS

Foreword...iii Recording Serial Numbers and Software Versions...iii Patent Information...iv Meanings of Symbols used in this Manual...iv Meanings of Symbols used on the Injector...v Classification in accordance with EN60601...vii Type of protection against electric shock...vii Degree of protection against electric shock...vii Degree of Protection against ingress of water...vii Degree of Safety of Application in the presence of a Flammable anaesthetic Mixture with Air or with Oxygen or Nitrous Oxide...vii Emission Standard...vii UL/CSA Classification...vii CE Mark Information... viii

OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM... 1-1-1 1.1 Indications for Use...1-1-1 1.1.1 Contraindications... 1-1-1 1.2 User Qualifications...1-2-1 1.3 Configuration of Unit...1-3-1 1.4 Safety Features...1-4-1 1.4.1 Self-testing Design... 1-4-1 1.4.2 Patency CheckTM Feature ... 1-4-1 1.4.3 Timing BolusTM Feature... 1-4-1 1.4.4 Drip Mode Feature... 1-4-1 1.4.5 Electrically Isolated Syringe... 1-4-1 1.4.6 Syringe Clarity... 1-4-1 1.4.7 Positive Positioning of the Powerhead... 1-4-1 1.4.8 Hand Start switch Operation... 1-4-1 1.4.9 Physical Stability of Remote Stand... 1-4-2

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Contact Information...ii

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I-INTRODUCTION

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 Electrical Leakage... 1-5-1 1.5.5 Environmental... 1-5-2 1.5.6 Compatible Syringe Sizes... 1-5-4 1.5.7 Programmable Flow Rate (A-side)... 1-5-4 1.5.8 Programmable Flow Rate (B-side)... 1-5-4 1.5.9 Programmable Volume (A-side)... 1-5-4 1.5.10 Programmable Volume (B-side)... 1-5-4 1.5.11 Programmable Pressure Limit ... 1-5-5 1.5.12 Programmable Scan Delay... 1-5-5 1.5.13 Programmable Inject Delay... 1-5-5 1.5.14 Programmable Phase Delay... 1-5-5 1.5.15 Programmable Drip Injection Parameters (B-Side)... 1-5-6 1.5.16 Protocol Memory... 1-5-6 1.5.17 Inject Results... 1-5-6 1.6 Consumables...1-6-1 1.6.1 Compatible Syringe... 1-6-3 1.6.2 Low Pressure Tubing... 1-6-3 1.6.3 Multipack Disposables... 1-6-3 1.6.4 OptiMARK (gadoversetamide injection) Prefilled Syringes... 1-6-3 1.6.5 Dotarem (gadoterate meglumine) Prefilled Syringes... 1-6-4 1.6.6 Prefilled Saline Syringe... 1-6-4 1.7 Accessories AND cOMPONENTS...1-7-1 Accessories... 1-7-1 Components... 1-7-1

POWER ON / POWER OFF... 2-1-1 2.1 Turning System Power ON...2-1-1 2.2 Turning System Power OFF...2-2-1

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xi CONSOLE... 3-1-1 3.2 Console Display Modes of Operation...3-2-1 3.2.1 Main Screen... 3-2-1 3.2.2 Memory Screen, System Info Screen, Results Screen and [Enable] Key... 3-2-1 3.3 Description of Screens...3-3-1 3.3.1 Main Screen... 3-3-1 3.3.2 Memory Screen ... 3-3-5 Retrieving a Protocol from Memory...3-3-6 Deleting a Protocol from Memory...3-3-7 Storing a Protocol in Memory...3-3-9 Editing a Protocol Name... 3-3-11 3.3.3 System Information Screen...3-3-13 Selectable Features... 3-3-13 Information Displayed... 3-3-14 3.3.4 Injection Results Screen...3-3-16 3.3.5 Enabled Screen...3-3-18 3.3.6 Drip Mode Screen...3-3-19 3.3.7 Accessing the Drip Infusion Progress Screen...3-3-22 3.3.8 Drip Infusion Completed Screen...3-3-24

POWERHEAD... 4-1-1 4.1 Description of Powerhead...4-1-1 4.1.1 Powerhead Features... 4-1-1 4.1.2 Description of Powerhead Keys... 4-1-4 4.2 Filling Syringes...4-2-1 4.3 Purge Air from Syringe and Tubing/Install Syringe(s)...4-3-1 4.3.1 Contrast Only Injection... 4-3-1 4.3.2 Begin injecting contrast followed with a saline flush... 4-3-4 Using 50 ml / 60 ml Saline Syringe...4-3-4 Using 125 ml Saline Syringe...4-3-8 4.3.3 Begin injection with Drip Mode, Patency Check, or Timing Bolus ...4-3-11 Using 125 ml Saline Syringe... 4-3-13

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3.1 Turning the System ON...3-1-1

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xii DELIVERING AN INJECTION... 5-1-1 5.1 Safety Instructions...5-1-1 5.2 Load Syringe(s) / Enter Parameters / Connect Patient...5-2-1 5.3 Check Patency of I.V. Site...5-3-1 5.4 Delivering a Drip Mode Injection...5-4-1 5.5 Delivering the Main Protocol...5-5-1 5.6 Prematurely Stopping an Injection...5-6-1 5.7 Restarting a Prematurely Stopped Injection...5-7-1

SYSTEM GENERATED MESSAGES AND ALARMS... 6-1-1 6.1 System Generated Messages/Indications...6-1-1 6.1.1 * Asterisk: Protocol Retrieved from Memory has been Modified... 6-1-1 6.1.2 Volume Key Flashing a Magenta Color... 6-1-1 6.1.3 Pressure Limited Injection... 6-1-2 6.2 System Generated Alarms...6-2-1

CARE OF UNIT... 7-1-1 7.1 Preventive Maintenance and Service...7-1-1 7.2 Daily Inspection...7-2-1 7.3 Cleaning ...7-3-1 7.3.1 Syringe Holder... 7-3-1 7.3.2 Powerhead ... 7-3-2 7.3.3 Console... 7-3-2 7.3.4 Power Control... 7-3-2 7.3.5 Power supply... 7-3-2

ELECTROMAGNETIC COMPATIBILITY GUIDANCE... A-1 INDEX

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I-1-1

1-1-1

The purpose of this manual is to provide instructions for using the OptiStar Elite MR Contrast Delivery System in order to ensure patient safety. For safe operation, it is important that this manual be read carefully and its recommended procedures followed.

1.1 INDICATIONS FOR USE The OptiStar Elite MR Contrast Delivery System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient’s vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.

1.1.1 CONTRAINDICATIONS Contraindications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

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1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

1

OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

1-1-2

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1-2-1 1.2 USER QUALIFICATIONS

Training made available upon installation by the manufacturer and repeat of training available upon request.

CAUTION!

.

Federal (USA) law restricts this device to sale by or on the order of a physician. (21CFR 801.109(6)(1).

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1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

The OptiStar Elite MR Contrast Delivery System Injection System should ONLY be operated by qualified health care professionals who have been trained in the use of this equipment and have read and understand this manual.

1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

1-2-2

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1-3-1 1.3 CONFIGURATION OF UNIT

The console, filter, and the power supply are not designed to be placed in the MRI area and must be set up in a separate viewing room. The power control, powerhead and remote stand have been specifically designed so that they may remain in the MRI area throughout the procedure without interference. NOTE: Refer to section 1.5.5 Environmental for further information concerning component location. WARNING! No modification of this equipment is allowed.

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1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

The OptiStar Elite MR Contrast Delivery System is specially designed to be used in conjunction with MRI equipment. The unit consists of the components shown in Figure 1-3-1.

1-3-2

1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

The console A contains a touch-sensitive display screen which provides the ability to change the injection parameters, store protocols and retrieve protocols. Information about the console is found in Chapter 3-Console Screens. A hand start switch B , a remote control device which attaches to the rear of the console, is included so that the injection process may be started and stopped from outside the MRI area. The powerhead C is specifically designed from materials which will not affect nor be affected by the magnetic fields of the MR scanner. Note, however, the Powerhead Cable Connector (connects into the Power Control) is MR conditional. Information about the Powerhead is found in Chapter 4- Description of the Powerhead. The remote stand D allows easy placement of the powerhead for operator and patient convenience. The power system consists of one Power Control E 1 , one Power Supply (with mounting bracket) E 2 and one EFI/RFI Filter E 3 . Both the Power Control and the Communication Cable (from the filter to the Power Control) are MR Conditional. More information about the power system is found in Chapter 2- Power ON / Power OFF.

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1-3-3

MR

C A

60 ml 10/15/2 30 ml 0 ml

B 60 ml50 ml 125 ml

A E1

E2

B

Control and Equipment Rooms

AC Outlet

D

Dividing Wall

Magnet Room

Figure 1-3-1 Overview of System

NOTE: Refer to section 1.5.5 Environmental for further information concerning component location and safety conditions.

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1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

E3

MR

MR

1-OVERVIEW OF THE OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM

1-3-4

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