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Table of Contents
Related Manuals for Belmont RI-2
Summary of Contents for Belmont RI-2
- Page 1 OPERATOR’S MANUAL...
- Page 2 OPERATOR’S MANUAL Belmont Medical Technologies 780 Boston Road Billerica, MA 01821, USA Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands +31 (0) 70 345 8570 780 BOSTON ROAD BILLERICA, MA 01821, USA All service calls & questions should be directed to: T: 866.663.0212...
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Page 3: Table Of Contents
Introduction ...................... 1-1 Indications for Use ................... 1-1 Contraindications ..................... 1-1 ® Overview of the Belmont Rapid Infuser RI-2 ........... 1-2 Control Panel: Display and Keys ..............1-3 Chapter 2: Operation Introduction ...................... 2-1 Step-by-Step Operating Procedures ..............2-2 Inspecting the System ................2-2 IV Pole Mounting .................. - Page 4 Page No. Chapter 3: Alarms and Troubleshooting Guide Introduction ...................... 3-1 Operational Alarms ..................3-1 Air Detection ..................3-1 Door Open .................... 3-2 Fluid Out ....................3-2 High Pressure ..................3-3 Low Battery ..................3-3 Missing Disposable................3-3 Heating Alarms ....................3-4 System Error #101 (Heating Fault) ............
- Page 5 6. Clean the pump head ................. 4-17 Checklist ......................4-18 Electromagnetic Compatibility ................ 4-20 Fuse ....................... 4-22 Calling for Service ..................4-22 ® Chapter 5: Technical Specifications of the Belmont Rapid Infuser RI-2 Dimensions ...................... 5-1 Portability ......................5-1 Power AC ......................5-1 Battery ......................5-1 Environment .....................
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Page 6: Introduction
This system is not intended for drug administration. • ® The Belmont Rapid Infuser RI-2 should not be used where rapid infusion is • medically contraindicated. Lactated Ringer’s solution, dextrose in water, and hypotonic sodium chloride • solutions should not be added to blood components (AABB Technical Manual... -
Page 7: Overview Of The Belmont ® Rapid Infuser Ri-2
The complete system consists of the Belmont Rapid Infuser RI-2 Control System, which ® is mounted on an IV pole, and the Disposable Set. The Belmont Rapid Infuser RI-2 can be used only with the supplied disposables. A large volume 3-liter reservoir is available as an optional accessory for convenience in cases involving very large infusion volumes, see page 2-4. -
Page 8: Control Panel: Display And Keys
CONTROL PANEL SUMMARY Status Display: ® Flow Rate in ml/min (The Belmont Rapid Infuser RI-2 • displays both the user Set Flow Rate and the Actual Flow Rate) Volume Infused •... -
Page 9: Chapter 2: Operation
This chapter explains the procedure for setting up and initiating safe and effective operation of ® the Belmont Rapid Infuser RI-2. To change screens’ language, select language at start-up or go to Chapter 4 “LANGUAGE SETUP” to setup your preferred language. WARNING! Do not use this product in the presence of flammable anesthetics. -
Page 10: Step-By-Step Operating Procedures
Check that the system is locked in place before proceeding. Clamp the reservoir support onto the IV pole approximately 9" above the Belmont ® Rapid Infuser RI-2. Make certain that there is nothing obstructing •... -
Page 11: Installing The Disposable Set
Chapter 2: Operation INSTALLING THE DISPOSABLE SET 1. Snap reservoir chamber into the reservoir support clamp. WARNING: The disposable set is for single patient use only. Do not reuse. 2. Open the door. Insert heat exchanger with red arrow Store the disposable set in a dry well- pointing up (Red tinted ventilated area free from exposure to tubing to red stripe on unit.) -
Page 12: Installing The Optional Large Reservoir
Chapter 2: Operation INSTALLING THE OPTIONAL LARGE RESERVOIR Install large reservoir holder • Install large reservoir • Using aseptic techniques, remove the reservoir chamber from the 3-Spike disposable set by disconnecting the luer connectors. Disconnect the larger pump tubing by pressing •... -
Page 13: Powering On The System
Chapter 2: Operation POWERING ON THE SYSTEM Turn power on by firmly pressing the circuit breaker Check that the detachable power cable • to the ON position. The system will perform a self- is securely seated in the main power check to check the integrity of system parameters. -
Page 14: Priming The Main System
Chapter 2: Operation PRIMING THE MAIN SYSTEM Press PRIME to recirculate 100 ml of fluid at 500 Prime the main system with solution ml/min to remove air and replace the main system compatible with blood. Do not prime with with fluid. blood. -
Page 15: Connecting To Patient
Normal Saline (60% Hematocrit) and solutions compatible with blood. *All catheters are plastic material +Data on file at Belmont INITIATING INFUSION Press INFUSE to start infusing at 10 ml/min. Press 500 ML/MIN key to infuse at 500 ml/min or adjust flow rate, as needed, by pressing INFUSE RATE ▲/INFUSE RATE ▼... -
Page 16: Maintaining Infusion
Chapter 2: Operation MAINTAINING INFUSION Routinely check patient and system parameters, on screen. Respond to and correct system alarms. CAUTION: Replace reservoir chamber or disposable set when the filter becomes clogged. If it becomes occluded the fluid out sensor will activate, an audible alarm will sound, a message “Fluid Out, Check inlet tubing and Filter. -
Page 17: Bolus Infusion (Infuse A Fixed Volume)
Chapter 2: Operation BOLUS INFUSION (INFUSE A FIXED VOLUME) Deliver fixed volume, factory set to 200 ml, at a rate of 200 ml/min. To change the flow rate during the bolus infusion, press the INFUSE RATE ▲ or INFUSE RATE ▼ or 500 ml/min RATE key. -
Page 18: Battery Operation
Chapter 2: Operation BATTERY OPERATION Press RECIRC key to preheat fluid in the reservoir chamber. Unplug the system from the wall outlet. The status line that displays temperature will be flashing BATTERY NO HEATING to indicate the system is now in battery mode, the maximum flow rate is 50 ml/min, and heating is suspended. -
Page 19: End Of Procedure
Chapter 2: Operation END OF PROCEDURE If the pump is on, press STOP. Clamp off the patient line and bag spikes. CAUTION: Turn the system to STANDBY, using the circuit With fluid in the disposable set and the breaker. system not powered on, keep the patient line clamped closed when opening the Open the door and remove the disposable set from the door to prevent uncontrolled fluid flow. -
Page 20: Introduction
® actions. When the Belmont Rapid Infuser RI-2 recognizes a situation that is compromising effective infusing, it stops pumping, heating, moves the valve wand into recirculate position, displays alarm message, instructions for corrective measure, and sounds an audible alarm. To mute an alarm and return to normal operation, select the MUTE key on the alarm message screen and follow the on-screen instructions. -
Page 21: Fluid Out
Chapter 3: Alarms and Troubleshooting Guide ALARM MESSAGE POSSIBLE OPERATOR ACTION CONDITION FLUID OUT Press MUTE to silence the alarm. Out of fluid. If out of fluid, add additional fluid and Bag clamps not press REPRIME. fully opened or fully spiked. Open bag clamp or fully spike the bag. -
Page 22: High Pressure
Chapter 3: Alarms and Troubleshooting Guide ALARM MESSAGE POSSIBLE OPERATOR ACTION CONDITION HIGH PRESSURE Patient line is Make certain that the flow path is not blocked. blocked. Recirculate line is Check that the recirculate line is not blocked. obstructed. Infusion site is not Check that the infusion site is well well placed. -
Page 23: Heating Alarms
Chapter 3: Alarms and Troubleshooting Guide HEATING ALARMS Heating alarms which may occur are: ALARM MESSAGE POSSIBLE CONDITION OPERATOR ACTION Check disposable set and flow path for SYSTEM ERROR #101 Heater Fault occlusions. Make certain the windows on the disposable set and the IR probes are clean CHECK Wet, dirty or blocked and dry. -
Page 24: Hardware Alarms
Chapter 3: Alarms and Troubleshooting Guide HARDWARE ALARMS ALARM MESSAGE POSSIBLE CONDITION OPERATOR ACTION SYSTEM ERROR #201 Air detector failure Power off and restart. Service machine if error persists. POWER OFF AND RESTART. SERVICE MACHINE IF ERROR PERSISTS. SYSTEM ERROR #202 Fluid out detector failure Power off and restart. -
Page 25: System Error #208 Valve Failure
Chapter 3: Alarms and Troubleshooting Guide ALARM MESSAGE POSSIBLE CONDITION OPERATOR ACTION SYSTEM ERROR #208 Valve failure Check that the valve is not blocked. CHECK VALVE FOR Valve position sensor Power off and restart. Service machine if BLOCKAGE. POWER malfunction error persists. -
Page 26: Troubleshooting Other Operational Difficulties
Chapter 3: Alarms and Troubleshooting Guide TROUBLESHOOTING OTHER OPERATIONAL DIFFICULTIES Problems may occur that are outside the surveillance system due to improper setup, faulty accessory equipment, or internal failure of a component. Table below describes several of these potential problems, the alarm that might be generated (if any), and the corrective actions to take. - Page 27 Chapter 3: Alarms and Troubleshooting Guide PROBLEM POSSIBLE CONDITION OPERATOR ACTION Power off IGBT’s on Driver ‘A’ and ‘B’ If the problem persists, power off and service immediately after shorted. machine. switch to ON. System turns on for EPROM is not seated in Service machine.
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Page 28: Chapter 4: Parameter Setting And Preventive Maintenance
® The Belmont Rapid Infuser RI-2, requires minimal service and care. Preventive maintenance should be performed regularly to optimize performance and reduce the likelihood of downtime. Listed below are routine maintenance (as needed), periodic maintenance (at least once a year), and parameters setting. -
Page 29: System Setup
Parameter Setup changes is performed in the Service mode. Pressing the SERVICE key accesses the Calibration/Set-up mode. This key appears on the BELMONT logo screen only at system powered-up. This screen remains active for 4.5 seconds before the system enters the Prime mode. -
Page 30: Date/Time
Chapter 4: Parameters Setting and Preventative Maintenance Date/Time Press DATE TIME in the CALIBRATION/SET-UP screen to set the time and date. Press either the TIME or DATE key. Screen after pressing DATE TIME key A numerical keypad will be displayed. Enter the appropriate time or date information. Enter the appropriate time in 24-hour clock format (i.e. -
Page 31: Display Brightness
Chapter 4: Parameters Setting and Preventative Maintenance Display Brightness There are four (4) levels of display brightness. Press DISPLAY BRIGHT to change the present level of brightness to the next level. Language Setup Press this key to set screens to your preferred language. Key Rate The key rate sets up the sensitivity of the touch keys. -
Page 32: Service And Preventive Maintenance Schedule
Chapter 4: Parameters Setting and Preventative Maintenance SERVICE AND PREVENTIVE MAINTENANCE SCHEDULE Schedule 1 To be performed by either the Clinical User or a Biomedical Technician (BMET). Interval Routine Maintenance Before or After Every Every 6 Each Use Month Months 1. -
Page 33: Routine Maintenance
Chapter 4: Parameters Setting and Preventative Maintenance ROUTINE MAINTENANCE Clean and/or Disinfect Exterior Clean the outside surfaces of the system and inside the door after each use. Turn the pump to STANDBY and unplug the power cord. Wipe the surface with a cloth moistened with water or isopropyl alcohol. Note: Avoid the use of acetone or other solvents that might damage the surface. -
Page 34: Instrument Door And Ceramic Disks
Chapter 4: Parameters Setting and Preventative Maintenance Instrument Door and Ceramic Disks The instrument door must fit properly for the system to operate correctly. The platen part of the roller pump is located on the door. The platen must line up properly with the pump. Check hinges for blood build-up, clean any dried blood from hinge area. -
Page 35: Testing The System And Operational Check-Out
Chapter 4: Parameters Setting and Preventative Maintenance TESTING THE SYSTEM AND OPERATIONAL CHECK-OUT The device should be serviced periodically, in accordance to schedule 1 and 2, by a qualified technician. Material Required: Rapid Infuser Disposable Set, REF 903-00006 • Bio-Tek Safety Analyzer or equivalent •... -
Page 36: System Operational Checkout
Chapter 4: Parameters Setting and Preventative Maintenance System Operational Check-Out Install Disposable set. Turn power switch ON. Wait for PRIME screen to appear. Close bag clamps. Hang and spike fluid bag. Open bag clamp(s). Press PRIME to prime the system (circulate 100 ml of fluid at 500 ml/min.) Prime volume (100 ml) countdown is displayed on screen. -
Page 37: Electrical Safety Test - Leakage Current
Switch selector on Analyzer to CHASSIS or LEAKAGE (µA). Connect a single red lead to the SINGLE LEAD input jack and ® attach large clamp to equipotential ground terminal on the Belmont Rapid Infuser RI-2. iii. Record the leakage current displayed for each of the following conditions, with Neutral switch in NORM position. - Page 38 ® iii. Prime the Belmont Rapid Infuser RI-2 with saline. Make sure that the entire patient line including the cannula has been primed. ® Repeat a.iii, and a.iv with the Belmont Rapid Infuser RI-2 in the STANDBY (ON) and pumping at 750 ml/min modes.
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Page 39: Hardware Verification
Chapter 4: Parameters Setting and Preventative Maintenance Hardware Verification Install and prime the disposable set before beginning the Hardware Verification process. Hardware mode verifies: Valve operation Fluid Out and Air Detectors Battery voltage. Flow Rate (Pump speed) Input and Output Temperature Probes including “Over Temperature” alarm test, and Pressure sensor. - Page 40 Chapter 4: Parameters Setting and Preventative Maintenance Hardware Status Screen Status Line Reading Pump Speed 0, 10, 100, 500, 750, and an optional 1000 ml/min Input Temperature Temperature in ºC, probe ambient reference in parentheses Output Temperature Temperature in ºC, probe ambient reference in parentheses Pressure Pressure in mmHg Fluid Out Detector Status Air or Fluid...
- Page 41 Chapter 4: Parameters Setting and Preventative Maintenance Hardware Verification: Valve Press LEFT VALVE, confirm that the valve wand (valve pincher) moves to the left. Press OPEN VALVE, confirm that valve wand moves to the middle position. iii. Press RIGHT VALVE, confirm that the valve wand moves to the right. Leave the valve in the LEFT VALVE position before continuing to the next step.
- Page 42 Chapter 4: Parameters Setting and Preventative Maintenance Press PUMP SPEED again to change the pump speed to 100 ml/min. The accepted tolerance is 19.65 rpm ± 10%. iii. Press once more to change speed to 500 ml/min and repeat the measurement. The accepted tolerance is 97 rpm ±...
- Page 43 Chapter 4: Parameters Setting and Preventative Maintenance Pressure Transducer WARNING! Do not apply excessive pressure to the pressure chamber or pressure transducer. The pressure transducer is a precision electromechanical device and can be damaged with excessive force. Do not use the system if the pressure transducer is damaged.
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Page 44: Clean The Pump Head
Chapter 4: Parameters Setting and Preventative Maintenance Clean the Pump Head Roller Pump Retaining Screw The pump head can be removed and cleaned if needed. Turn the pump to STANDBY and unplug the power cord. Unscrew the retaining screw that holds the pump head. Remove the pump head and clean with water and soap. -
Page 45: Checklist
Chapter 4: Parameters Setting and Preventative Maintenance CHECKLIST RI-2 S/N: Tested By: Date: Equipment Safety Analyzer S/N: Cal Due Date: Used: Pressure Source S/N: Cal Due Date: Thermometer S/N: Cal Due Date: Tachometer S/N: Cal Due Date: Results 1. Visual Inspection: Right Hand Side √... - Page 46 Chapter 4: Parameters Setting and Preventative Maintenance Electrical Safety Test - Leakage Current Results Sheet Earth Leakage Currents (all measurements are in μA) Polarity - N; Polarity - R; Polarity - R; Polarity - N; Ground - N Ground - N Ground - O Ground - O Unit in STANDBY...
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Page 47: Electromagnetic Compatibility
Chapter 4: Parameters Setting and Preventative Maintenance ELECTROMAGNETIC COMPATIBILITY WARNING! Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility [EMC] information provided in the accompanying documents. WARNING! Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. - Page 48 Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems ® The Belmont Rapid Infuser RI-2 is intended for use in the electromagnetic environment specified below. The ® customer or user of the Belmont Rapid Infuser RI-2 should assure that it is used in such an environment.
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Page 49: Fuse
Chapter 4: Parameters Setting and Preventative Maintenance FUSE The fuse on the AC/DC supply marked F1 is rated as 1.25A, 250V, fast acting, 5x20mm with interrupting rating (breaking capacity) of 35A@250VAC. CALLING FOR SERVICE USA: 855.397.4547 Worldwide: 1.978.663.0212 Prior to returning any product, please obtain a Return Goods Authorization (RGA) number. Before calling, please have the serial number of the unit. -
Page 50: Chapter 5: Technical Specifications Of The Belmont
Chapter 5: Technical Specifications ® Technical Specifications of the Belmont Rapid Infuser RI-2 DIMENSIONS Size 13.5" x 12" x 7.5" (34.29cm x 30.48cm x 19.05cm) Weight 28 lbs (12.7 Kg) PORTABILITY Hand Carry Handle on top of unit for easy transport IV Pole Mount IV pole mountable or free standing. -
Page 51: Environment
Chapter 5: Technical Specifications ENVIRONMENT Operating Temperature 10ºC to 32ºC (50ºF to 90ºF) Relative Humidity 10% to 90% Pressure 49-103 kPa Shock and Vibration Meet MIL STD.810E method 514.4 (Basic Transportation) OPERATING PARAMETERS Flow Rate 10 - 750 ml/min, with a 1000 ml/min as an option, in 10 ml/min steps plus 2.5 and 5.0 ml/min with fluids of viscosity 1 to 8 centipoise (Water and crystalloid fluids through packed red cells) -
Page 52: Operating Panel
Chapter 5: Technical Specifications OPERATING PANEL Control Panel and Display Splash proof touch screen display Display Area Diagonal screen 5.7” (14.5 cm) Status Display Flow rate (ml/min) Total volume infused (ml) Line pressure (mmHg) Output infusate temperature (ºC) Bolus volume (ml) Alarm messages Functional Keys Keys are displayed appropriate to the particular point in... -
Page 53: Alarm States And Controls
Chapter 5: Technical Specifications ALARM STATES AND ALARM MESSAGES CONTROLS Operator Setting, User- MISSING DISPOSABLE correctable DOOR OPEN FLUID OUT AIR DETECTION HIGH PRESSURE System Status LOW BATTERY Heating Alarms SYSTEM ERROR #101 & 102 Hardware Alarms SYSTEM ERROR #201, 202, 203, 204, 205, 206, 207, 208, 209 &... -
Page 54: Classifications
Chapter 5: Technical Specifications CLASSIFICATIONS Type of Protection Against Electric Class I, or internally powered Shock Degree of Protection Against Electric CF defibrillator-proof at the end of patient line Shock for applied part Degree of Protection Against IPX2 Harmful Ingress of Water Method of Sterilization Ethylene Oxide. -
Page 55: Symbols And Definitions
Chapter 5: Technical Specifications SYMBOLS AND DEFINITIONS Symbol Description Compliance to Medical Device Directive 93/42/EEC and 2011/65/EU Alternating current Equipotentiality Standby Caution Consult accompanying documents/refer to manual Defibrillator-proof type CF equipment IPX2 Protected against dripping water Serial Number Manufactured by Authorized European Representative Waste Electrical and Electronic Equipment... -
Page 56: Waste Electrical And Electronic Equipment
Chapter 5: Technical Specifications Waste Electrical and Electronic Equipment (WEEE) The crossed-out wheel bin symbol on the product, literature, or packaging reminds you that all electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies to the European Union and other locations where separate collection systems are available.
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