Operators Manual
92 Pages
Preview
Page 1
L IEBEL- F LARSHEIM Liebel-Flarsheim
Optistar LE TM
Digital Injection System
A
10/15
60 ml ml /20 30 ml
B 60 50ml ml 125 ml
Operator's Manual 802700-A
ii
0-Introduction
FOREWORD Congratulations on the purchase of your Liebel-Flarsheim Optistar LE Injection System. The Optistar LE represents our effort to provide a quality product to support better health care throughout the world. 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 LE. Retain this manual for future reference. LIEBEL-FLARSHEIM TECHNICAL SUPPORT Phone No. 1-800-877-0791
RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS To facilitate requests for information, replacement parts or optional accessories, please record the serial numbers (S/N) located on the components along with the listed data. Unit S/N (located on powerpack and pedestal) Powerhead S/N Console S/N Date of Installation
/
/
Installing Company ___________________________________ Address _____________________________________________ Phone Number _______________________________________ Software version numbers may be accessed via the System Informtion key on the Injection Results Screen (refer to Chapter 3). Console ______________________________________________ Power Control ________________________________________
Optistar™ LE is a trademark of Mallinckrodt, Inc. 802700-A July 2002
iii MEANINGS OF SYMBOLS USED IN THIS MANUAL
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.
WARNING! - Electrical hazards which could result in personal injury.
Non-Anesthetic proof
! 115V
Attention, consult accompanying documents.
115 V.A.C. (alternating current).
Protective earth (ground).
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0-Introduction
Please regard any message that follows the word Danger, Warning or Caution!
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0-Introduction
MEANINGS OF SYMBOLS USED ON THE INJECTOR Console connection identifier. Powerhead connection identifier. Power Control connection identifier.
Hand Start switch connection identifier.
System OFF/ON (only for the Console).
Power ON/OFF.
Ram movement identifier: A-side/B-side Light On=Enabled Light Flashing=power up, injecting or ram is moving Check to ensure that no air is in syringe and tubing before injecting.
Start Injection
Stop Injection Power Supply.
Fluid Detect Symbol Remote Stand Elevation Lock
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v CLASSIFICATION IN ACCORDANCE WITH I.E.C. 601 0-Introduction
Type of protection against electric shock Class I equipment
Degree of protection against electric shock Type CF applied part (Powerhead).
Type B applied part (Console and Power Control)
C
LA
SSIFIE
D
C
Degree of Protection against ingress of water Ordinary Equipment.
¨
US
33SL
Optistar LE CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601-1 33SL Optistar LE CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/ CSA C22.2 NO. 601.1, 33SL 0123
Conforms to the European Medical Device Directive (MDD)
EMISSION’S STANDARD The Optistar LE meets emission’s standard IEC 601-1-2 Class B
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TABLE OF CONTENTS RECORDING SERIAL NUMBERS AND SOFTWARE VERSIONS ... II MEANINGS OF SYMBOLS USED IN THIS MANUAL ... III MEANINGS OF SYMBOLS USED ON THE INJECTOR ...IV CLASSIFICATION IN ACCORDANCE WITH I.E.C. 601 ...V Type of protection against electric shock ... v Degree of protection against electric shock ... v Degree of Protection against ingress of water ... v EMISSION’S STANDARD ...V
OVERVIEW OF THE OPTISTAR LE ... 1-1-1 1.1 INDICATIONS FOR USE ...1-1-1 1.2 CONFIGURATION OF UNIT ...1-1-1 1.3 USER QUALIFICATIONS ...1-1-1 Figure 1-1-1 Overview of System ...1-1-2 1.4 SYSTEM FEATURES ...1-1-3 1.4.1 CONSOLE ...1-1-3 1.4.2 HANDSWITCH ...1-1-4 1.4.3 POWERHEAD ...1-1-4 1.4.4 REMOTE STAND...1-1-4 1.4.5 POWER SYSTEM ...1-1-4 1.5 SAFETY FEATURES ...1-1-5 1.5.1 SELF-TESTING DESIGN ...1-1-5 1.5.2 ELECTRICALLY ISOLATED SYRINGE ...1-1-5 1.5.3 SYRINGE CLARITY ...1-1-5 1.5.4 POSITIVE POSITIONING OF THE POWERHEAD ...1-1-5 1.5.5 HAND START SWITCH OPERATION ...1-1-5 1.5.6 PHYSICAL STABILITY ... 1-1-5
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0-Introduction
FOREWORD ... II
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0-Introduction
1.6 SPECIFICATIONS ...1-1-6 1.6.1 DIMENSIONS ...1-1-6 1.6.2 WEIGHT ... 1-1-6 1.6.3 POWER REQUIREMENTS ... 1-1-7 1.6.4 ELECTRICAL LEAKAGE ...1-1-7 1.6.5 ENVIRONMENTAL ...1-1-8 1.6.6 SYRINGE SIZES ... 1-1-9 1.6.7 PROGRAMMABLE FLOW RATE (A-SIDE) ...1-1-9 1.6.8 PROGRAMMABLE FLOW RATE (B-SIDE) ...1-1-9 1.6.9 PROGRAMMABLE VOLUME (A-SIDE) ...1-1-9 1.6.10 PROGRAMMABLE VOLUME (B-SIDE) ... 1-1-9 1.6.11 PROGRAMMABLE PRESSURE LIMIT (A-SIDE) ...1-1-9 1.6.12 PRESSURE LIMIT (B-SIDE) ... 1-1-9 1.6.13 PROGRAMMABLE SCAN DELAY ... 1-1-10 1.6.14 PROTOCOL MEMORY ... 1-1-10 1.6.15 INJECT RESULTS ...1-1-10 1.7 CONSUMABLES ...1-1-10 1.7.1 SYRINGES ...1-1-10 1.7.2 LOW PRESSURE TUBING ... 1-1-10 1.7.3 MULTIPAK DISPOSABLES ... 1-1-10
POWER ON/OFF ... 2-1-1 2.1 TURNING THE SYSTEM POWER ON ...2-1-1 2.2 TURNING THE SYSTEM POWER OFF ... 2-1-1 Figure 2-1-1 Turning the System Power ON ... 2-1-2
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ix CONSOLE SCREENS ... 3-1-1 Figure 3-1-1 Location of the System ON/OFF key ...3-1-1 3.2 SELECTING THE INJECT MODE ...3-2-1 Figure 3-2-1 Location of the Console’s Inject Mode Key ...3-2-1 3.3 DESCRIPTION OF INJECT MODES ...3-3-1 3.3.1 SINGLE PHASE INJECTION (A-SIDE) WITH SALINE FLUSH (B-SIDE): SET UP SCREEN ...3-3-1 Figure 3-3-1 Single Phase Injection with Saline Flush: Set Up Screen ...3-3-1 3.3.2 TWO PHASE INJECTION (A-SIDE) WITH SALINE FLUSH (B-SIDE): SET UP SCREEN ...3-3-2 Figure 3-3-2 Two Phase Injection with Saline Flush: Set Up Screen ...3-3-2 3.3.3 SINGLE PHASE INJECTION (A-SIDE) WITHOUT SALINE FLUSH: SET UP SCREEN ...3-3-3 Figure 3-3-3 Single Phase Injection only-no flush: Set Up Screen ...3-3-3 3.3.4 DESCRIPTION OF PARAMETER KEYS/INFORMATION ON THE SET UP SCREENS ...3-3-4 Figure 3-3-4 Description of Parameter Keys and Information on the Set Up Screen ...3-3-5 3.4 DESCRIPTION OF PROGRESS SCREENS ...3-4-1 Figure 3-4-1 Location of the Start key ...3-4-1 3.4.1 SINGLE PHASE INJECTION (A-SIDE) WITH SALINE FLUSH (B-SIDE): PROGRESS SCREEN ... 3-4-2 Figure 3-4-2 Single Phase Injection with Saline Flush: Progress Screen ...3-4-2 3.4.2 TWO PHASE INJECTION (A-SIDE) WITH SALINE FLUSH (B-SIDE): PROGRESS SCREEN ... 3-4-2 Figure 3-4-3 Two Phase Injection with Saline Flush: Progress Screen ...3-4-2 3.4.3 SINGLE PHASE INJECTION (A-SIDE) WITHOUT SALINE FLUSH: PROGRESS SCREEN ...3-4-3 Figure 3-4-4 Single Phase Injection only-no flush: Progress Screen ...3-4-3
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3.1 TURNING THE SYSTEM ON ...3-1-1
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0-Introduction
3.4.4 DESCRIPTION OF INFORMATION ON THE PROGRESS SCREENS ...3-4-4 Figure 3-4-5 Description of Information on the Progress Screens ... 3-4-5 3.5 DRIP MODE...3-5-1 3.5.1 ACCESSING THE DRIP MODE ... 3-5-1 Figure 3-5-1 Location of the Drip Mode key on the Single Phase Injection Setup Screen ...3-5-1 Figure 3-5-2 Drip Mode Set up Screen ... 3-5-2 Figure 3-5-3 Description of Parameter Keys and Information on the Drip Mode Screen ...3-5-2 3.5.2 DESCRIPTION OF PARAMETERS/INFORMATION ON THE DRIP MODE SET UP SCREEN ...3-5-3 3.5.3 ACCESSING THE DRIP INFUSION SCREEN ...3-5-4 Figure 3-5-4 Drip Infusion Screen ...3-5-4 3.5.4 DESCRIPTION OF PARAMETERS/INFORMATION ON THE DRIP INFUSION SCREEN ... 3-5-4 Figure 3-5-5 Description of Parameter Keys and Information on the Drip Infusion Screen ...3-5-5 3.6 PROTOCOL MEMORY ... 3-6-1 Figure 3-6-1 Location of the Memory key ...3-6-1 Figure 3-6-2 Memory List Screen ... 3-6-2 3.6.1 RETRIEVING A PROTOCOL FROM MEMORY ... 3-6-3 Figure 3-6-3 Retrieving a Protocol from Memory ...3-6-3 3.6.2 DELETING A PROTOCOL FROM MEMORY ... 3-6-4 Figure 3-6-4 Deleting a Protocol from Memory ... 3-6-4 3.6.3 STORING A PROTOCOL IN MEMORY ...3-6-5 Figure 3-6-5 Storing a Protocol in Memory ... 3-6-6 3.6.4 EDITING A PROTOCOL NAME ...3-6-7 Figure 3-6-6 Editing a Protocol Name ... 3-6-7 3.7 INJECTION RESULTS SCREEN ...3-7-1 Figure 3-7-1 Accessing the Injection Results Screen ...3-7-1 3.8 SYSTEM INFORMATION SCREEN ... 3-8-1 Figure 3-8-1 Accessing the System Information Screen ... 3-8-2
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xi POWERHEAD ... 4-1-1 4.1.1 FEATURES ...4-1-2 Figure 4-1-1 Powerhead ...4-1-3 4.1.2 DESCRIPTION OF POWERHEAD KEYS ...4-1-4 Figure 4-1-2 Powerhead (Repeated) ...4-1-5 4.2 FILLING SYRINGES ...4-2-1 Figure 4-2-1 Remove the Spike Cover ...4-2-1 Figure 4-2-2 Fill the Syringe ...4-2-1 4.3 REMOVING AIR FROM THE SYRINGE AND TUBING ...4-3-1 4.3.1 TYPES OF INJECTIONS...4-3-1 4.3.2 METHODS FOR REMOVING AIR ...4-3-1 Figure 4-3-1 Remove the Spike ...4-3-1 Figure 4-3-2 Attaching the Tubing to A-side Syringe ...4-3-2 Figure 4-3-3 Installing the A-side Syringe ...4-3-3 Figure 4-3-4 Attaching the Y-Tubing to the A-side Syringe and B-side Syringe ...4-3-4 Figure 4-3-5 Purging Air from the Tubing ...4-3-5 Figure 4-3-6 Installing the Syringes ... 4-3-6
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4.1 DESCRIPTION OF POWERHEAD ...4-1-1
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0-Introduction
DELIVERING AN INJECTION ... 5-1-1 5.1 SAFETY INSTRUCTIONS ...5-1-1 5.2 DELIVERING AN INJECTION ... 5-2-1 Figure 5-2-1 Air Check key located on the Powerhead ...5-2-2 Figure 5-2-2 Location of the Start key on the Console Screen ...5-2-2 Figure 5-2-3 Start Key on the Powerhead ... 5-2-2 Figure 5-2-4 Pressing the Hand Start switch to start an injection ...5-2-3 5.3 PREMATURELY STOPPING AN INJECTION ...5-3-1 Figure 5-3-1 Pressing the Stop key on the Console will stop an injection ...5-3-1 Figure 5-3-2 Pressing the Stop key, or any key, on the Powerhead will stop an injection...5-3-2 Figure 5-3-3 Pressing the Hand Start switch will stop an injection ...5-3-2 5.4 RESTARTING AN PREMATURELY STOPPED INJECTION ...5-4-1
SYSTEM GENERATED ALARMS ... 6-1-1 Figure 6-1-1 Location of Alarm Message on the Console ... 6-1-1
INDEX ... I-1-1
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1-1-1
The purpose of this manual is to provide instructions for using the Optistar LE 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 LE is designed to inject LE contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans. Contraindications for the use of this device are determined by the prescribing physician at the time of use and upon the contrast media package inserts. Not to be used in a magnetic field greater than 1.5 Tesla.
1.2 CONFIGURATION OF UNIT The Optistar LE is specially designed to be used in conjunction with MRI equipment. The unit consists of the components shown in Figure 1-1-1. 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. 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.
WARNING! The console and the power supply are not designed to be placed in the MRI area and must be set up in a separate viewing room.
1.3 USER QUALIFICATIONS The Optistar LE Injector should ONLY be operated by qualified health care professionals who are completely familiar with the unit, have read and understand this Operator’s Manual, and are otherwise trained in the use of equipment and procedures of this type.
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 LE
1
OVERVIEW OF THE Optistar LE
1-1-2
1-Overview of the Optistar LE
C A
ml 10/15 30 60 /20 ml ml
B 60 50ml ml 125 ml
E1 D E2
A
E3
B
Figure 1-1-1 Overview of System
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1-1-3 1.4 SYSTEM FEATURES 1.4.1 CONSOLE A
Inject Modes through use of the Console The unit can be configured for the following injection modes: • Single phase injection A-side (contrast) with single phase flush B-side (saline) • Two phase injection A-side (contrast) with single phase flush B-side (saline) • Single phase injection A-side (contrast) without saline flush • Drip Mode Changeable Parameters • Flow Rate • Volume • Pressure Limit • Drip Interval • Scan Delay Timer Protocol Memory/Inject Results Screens The Optistar LE can store up to 20 protocols in memory. This information will remain in memory even after the unit has been turned off. Information about accessing the Protocol Memory screen is found in Chapter 3-Console Screens. The results of the last 12 injected protocols is also stored in memory. Information about accessing the Inject Results screen is found in Chapter 3-Console Screens.
WARNING! The console and the power supply are not designed to be placed in the MRI area and must be set up in a separate viewing room.
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1-Overview of the Optistar LE
The Console contains a touch-sensitive display screen which provides the ability to change values of the injection parameters, store protocols and retrieve protocols. Information about accessing these features is found in Chapter 3-Console Screens.
1-1-4
1-Overview of the Optistar LE
1.4.2 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. 1.4.3 POWERHEAD C The powerhead is specifically designed from materials which will not affect nor be affected by the magnetic fields of the MR scanner. Information about the Powerhead is found in Chapter 4-Description of the Powerhead. 1.4.4 REMOTE STAND D The remote stand is included to allow easy placement of the powerhead for operator and patient convenience. 1.4.5 POWER SYSTEM E The power system consists of one Power Control E1 , one Power Supply E2 and one EFI/RFI Filter E3 . More information about the power system is found in Chapter 2-Power ON/Power OFF.
WARNING! The console and the power supply are not designed to remain in the MRI area and should be set up in a separate viewing room.
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1-1-5 1.5 SAFETY FEATURES The Optistar LE has been designed to ensure the safety of both patient and operator. Specific safety features include:
When the Optistar LE is switched ON, it automatically performs a series of power-up tests to monitor the system status. If a problem is detected, an error code message will appear in the system display. Also, during the enable process and during an injection, all necessary functions are constantly checked. If a fault is detected, the system will automatically shut down and an error code message will be displayed. Refer to Chapter 7-Care of Unit for error code messages. 1.5.2 ELECTRICALLY ISOLATED SYRINGE All syringes are isolated from any electrical contact with the injector. 1.5.3 SYRINGE CLARITY Semitransparent syringes are used on the Optistar LE. If small air bubbles are present, they can be seen by visual inspection. 1.5.4 POSITIVE POSITIONING OF THE POWERHEAD A preset friction device in the powerhead holds the syringe in the desired position during injection. 1.5.5 HAND START SWITCH OPERATION Use of the hand start switch allows the operator to start and stop injections from within the view/control room. 1.5.6 PHYSICAL STABILITY The weighted base of the remote stand along with large casters reduces the possibility of tipping and increases its ability to roll over small cords. Looping the cables over the cable hangar helps keep the cables away from the wheels.
CAUTION! To prevent operator injury or equipment damage, the remote stand must be transported with the powerhead placed at the lowest position.
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1-Overview of the Optistar LE
1.5.1 SELF-TESTING DESIGN
1-1-6 1.6 SPECIFICATIONS
1-Overview of the Optistar LE
1.6.1 DIMENSIONS • Console Console Base
12.25” W X 8.5” H X 2.5” D (311.15mm W X 215.9mm H X 63.5mm D) 9.5” W X 2.5” H X 7” D (241.3mm W X 63.5mm H X 177.8mm D)
• Powerhead
7” W X 21.5” H X 5.5” D (177.8mm W X 546.1mm H X 139.7mm D)
• Remote Stand
27” diameter (base) X 43” H to 53” H (adjustable) (685.8mm diameter X 1092.2mm H to 1346.2mm H adjustable)
• Power Control
10” W X 4.25” H X 15.25” D (254mm W X 107.95mm H X 387.35mm D)
• Power Supply
10” W X 4.25” H X 9.5” D (254mm W X 107.95mm H X 241.3mm D)
• Filter
4”W X 10.0”H X 3”D (101.6mm x 254.0mm x 76.2mm)
1.6.2 WEIGHT • Console
5.8 lb. (2.6 kg)
• Power Control
16 lb. (7.26 kg)
• Powerhead (w/arm and cable)
14.5 lb. (6.57 kg)
• Remote Stand
29 lb. (13.00 kg)
• Power Supply
11.5 lb. (5.21 kg)
• Filter
10 lb. (4.54 kg)
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1-1-7 1.6.3 POWER REQUIREMENTS • Console 115 VAC ± 10% 230 VAC ± 10%
Frequency
50/60 Hz
Current
0.5 Amp.
1-Overview of the Optistar LE
Voltage
• Power Supply Voltage
115 VAC ± 10% 230 VAC ± 10%
Frequency
50/60 Hz ± 3Hz
Current
4 Amp.
1.6.4 ELECTRICAL LEAKAGE Chassis
less than 300 microamps
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1-1-8 1.6.5 ENVIRONMENTAL
1-Overview of the Optistar LE
• Transport and Storage: -4°F to +140°F (-20°C to +60°C) for 4 days; 10% to 100% relative humidity • Operation: +59°F to +95°F (+15°C to +35°C); 30% to 75% relative humidity, non-condensing; 700kPa to 1060kPa atmospheric pressure • Biohazard Disposal: Dispose of biohazards in accordance with the requirements of your hospital, facility or local regulations. • Electromagnetic Compatibility (EMC): The Optistar LE meets EN60601-1-2 for level B conducted and radiated emissions and EMI immunity. NOTE: If any anomalies in the injector performance are noticed, identify devices within the immediate area that are capable of producing electromagnetic interference and call a qualified service representative.
DANGER! Possible explosion hazard if used in the presence of flammable anesthetics.
WARNING! The injector console and power supply may only be operated in an area that is located outside of the 5 gauss limit. Operating the console or power supply within magnetic fields that are higher than this limit may cause the unit to malfunction, resulting in operator or patient injury. CAUTION!
Only the powerhead is considered spill proof. If fluid is spilled on the console or power control, remove the unit from operation and contact your authorized service personnel.
802700-A July 2002