Rapid Infuser RI-2 Operators Manual Rev 002

The Belmont® Rapid Infuser RI-2 Operator’s Manual Table of Contents Page No. Chapter 1: Introduction – System Overview Introduction ...6 User Environment ...6 Indications for Use ...6 Contraindications ...7 Overview of the Belmont® Rapid Infuser RI-2 ...7 Major Components of the Control System ...8 Control Panel: Display and Keys ...9 Chapter 2: Operation Introduction ...10 Warnings… ...10 Cautions…………………………………………………………………………………11 Compatible Fluids ...12 Step-by-Step Operating Procedures ...13 Inspecting the System ...13 IV Pole Mounting ...13 Installing the Disposable Set ...14 Installing the Optional Large Reservoir ...15 Powering on the System ...16 Installing Fluid Bag ...17 Priming the Main System ...18 Priming the Patient Line ...18 Connecting to Patient ...19 Initiating Infusion ...20 Maintaining Infusion...20 Pressure Control ...21 Automatic Air Purging ...21 Bolus Infusion (Infuse a Fixed Volume) ...22 Recirculation...22 Stop...22 Battery Operation ...23 Low Battery ...23 Accidental Power Off ...23 End of Procedure ...24 System Error ...24

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Page No. Chapter 3: Alarms and Troubleshooting Guide Introduction ...25 Information Signals ...25 Operational Alarms ...26 Air Detection ...26 Door Open ...26 Fluid Out...27 High Pressure...28 Missing Disposable...28 Heating Alarms ...29 System Error #101 (Heating Fault) ...29 System Error #102 (Over Temperature) ...29 Hardware Alarms ...30 System Error #201 (Air Detector Failure) ...30 System Error #202 (Fluid Out Detector Failure) ...30 System Error #203 (Heater Fault) ...30 System Error #204 (Heater Feedback Fault) ...30 System Error #205 (Heater Hardware Fault)...30 System Error #206 (Power Driver Module Overheating) ...30 System Error #207 (Pump Failure) ...30 System Error #208 (Valve Failure)...31 System Error #209 (Board Overheating)...31 System Error #210 (Internal Computer Malfunction) ...31 Troubleshooting Other Operational Difficulties ...32 Chapter 4: Parameter Setting and Preventive Maintenance Introduction ...34 System Setup ...35 1. Date/Time...36 2. Display Brightness ...37 3. Language Setup ...37 4. Key Rate ...37 5. Bolus Volume ...37 6. Pressure Limit ...37 Service and Preventive Maintenance Schedule ...38 Schedule 1...38 Schedule 2...38 Routine Maintenance ...39 1. Clean and/or Disinfect Exterior ...39 2. Fluid Out and In-Line Air Detectors...39 3. Power Cord ...39 4. Temperature Probes...39 5. Fan Guards ...39 702-00190 Rev. 002

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Page No. Testing the System and Operational Check-Out ...40 Materials Required...40 1. Visual Inspection ...40 2. Seals ...41 3. Instrument Door and Ceramic Disks ...41 4. Rubber Feet ...41 5. System Operational Checkout ...41 6. Battery Run Time ...42 7. Electrical Safety Test - Leakage Current ...42 8. Hardware Verification ...44 9. Clean the pump head ...49 Checklist ...50 Electromagnetic Compatibility ...52 Fuse...53 Calling for Service ...53 Chapter 5: Technical Specifications of the Belmont® Rapid Infuser RI-2 Dimensions ...54 Portability ...54 Power AC...54 Battery ...54 Environment...55 Operating Parameters ...55 Operating Panel ...56 Safety and Monitoring ...56 Alarm States and Controls ...57 Disposable Sets ...57 Disposable Environment ...57 Disposable Symbols and Definitions ...57 Classifications ...58 Symbols and Definitions...59 Waste Electrical and Electronic Equipment ...60

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Chapter 1: System Overview

It is essential that you read and understand this manual before operating the system. INTRODUCTION The Belmont® Rapid Infuser RI-2, warms blood, colloid, and crystalloid to physiologic temperature at user-set rates from 10 to 750 milliliters per minute (mL/min) with 1000 mL/min as an option. 2.5 and 5.0 mL/min (150 and 300 mL/hr) are also available to keep the venous line open. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. Keys appropriate to a particular point in the operation are displayed on the touch screen. A battery backup allows for mobile transport of the patient. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active. The builtin rechargeable battery automatically charges whenever the system is connected to line power. NOTE: Federal law (USA) restricts this device to sale by or on the order of a physician.

User Environment The operating environment for the Belmont® Rapid Infuser RI-2 is general operation in hospital or alternate care environments. The Belmont® Rapid Infuser RI-2 will be subject to the temperature, humidity, and pressure typical of a health care environment. Sources of shock, drop, and vibration are also those typically found in a health care environment. The Belmont® Rapid Infuser RI-2 is intended to be used by trained healthcare professionals.

INDICATIONS FOR USE •

Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.

•

Infusion of warmed fluid to re-warm patients after surgery or for hypothermia.

•

Infusion of warmed fluid for irrigation in urology procedures.

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Chapter 1: System Overview

CONTRAINDICATIONS The Belmont® Rapid Infuser RI-2 is designed to provide warmed blood and fluids from 2.5 mL/min to 1000 mL/min and should not be used where rapid infusion is medically contraindicated. •

mLmLThe system should not be used to warm platelets, cryo-precipitates, or granulocyte suspensions or unprocessed / non-anticoagulated blood products.

•

This system is not intended for drug administration.

•

Calcium containing solutions (ex. Lactated Ringer's solution), dextrose in water, and hypotonic sodium chloride solutions should not be added to blood components. Use only anticoagulated blood products.

OVERVIEW OF THE BELMONT® RAPID INFUSER RI-2 The complete system consists of the Belmont® Rapid Infuser RI-2 Control System, which can be 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 15. The Disposable Set is preassembled and has a sterile fluid path. It is intended for single patient use only. Disclaimer: the IV pole is not required for use; it is not considered a critical-detachable component and ordering an IV pole from Belmont is optional.

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Chapter 1: System Overview

Major Components of the Control System:

1. Fluid Out Detector detects and alarms at an out of fluid situation. 2. Power Switch turns system power on and off. 3. Roller Pump is designed for pumping accuracy and reliability.

IR (5) Probe

Display (4)

Air (6) Detector Valve (7) Wand

IR Probe (8)

Fluid Out (1) Detector Power (2) Switch

5. IR Temperature Probe (Output Probe) monitors output fluid temperature as it exits the Heat Exchanger.

6. Air Detector detects air in the line. If air is detected the valve wand is closed immediately to prevent air into the patient. Pumping and heating stop, alarm sounds Roller Pump and “Air Detection” message is displayed (3) on screen. 7. Valve wand closes off the recirculation line when the system is in the infusion mode and closes off the infusion line when the system is in the recirculation mode. It immediately closes the infusion line to the patient when an error condition occurs which may require user intervention.

System Diagram Showing Main Components

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4. Display and control panel show status and alarm messages with touch keys at the bottom of the screen.

8. IR Temperature Probe (Input Probe) monitors input fluid temperature as it enters the Heat Exchanger.

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Chapter 1: System Overview

CONTROL PANEL: DISPLAY AND KEYS The control panel consists of the touch screen display, which incorporates a bright graphical display with touch pad keys. The display shows status and alarm messages at the top and middle and contains the touch keys at the bottom. 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

•

Infusate Temperature in ºC

•

Pressure in the Fluid Line in mmHg

•

Bolus Volume (when infusion of a fixed bolus of fluid is desired).

Function Keys: The keys that control all system functions are displayed on the screen. The screen is changed each time a function key is pressed. Only keys that are relevant to the desired function are presented. The active key is highlighted. There are three (3) different levels of sensitivity: Fast, Medium, and Slow. The key sensitivity is set at the factory to medium but can be adjusted by the operator in SERVICE MODE. See Chapter 4, page 37 for ‘Key Rate’ sensitivity setup.

Alarm Display: Graphical alarm messages indicating where errors have occurred and suggested operator action.

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Chapter 2: Operation

INTRODUCTION 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.

WARNINGS •

Use a dedicated circuit breaker to avoid risk of supply interruption and for proper function of The Belmont Rapid Infuser RI-2. The Belmont draws maximum current under normal operating conditions and should be the only device operating on the circuit breaker.

•

Do not use with pressure infusers or “bag squeezers”. The system pump provides adequate pressure to infuse fluid.

•

Do not use this product in the presence of flammable anesthetics.

•

Do not use this product in an Oxygen rich environment.

•

Do not use this product in the presence of Nitrous Oxide.

•

The Belmont Rapid Infuser RI-2 should not be left unattended while in operation.

•

Disposable set is for single patient use only. Do not reuse.

•

Inspect and make certain that the patient line is completely primed and free of air. Any air bubbles after the valve wand in the patient line must be removed before the procedure can safely continue.

•

Once the door is opened, all safety features of the system may be bypassed. Clamp off the patient line to ensure that air is not allowed to enter the patient prior to opening the door to the RI-2.

•

WARNING: Do not infuse blood that is in the disposable set when over temperature condition occurs. Red cells that have been subjected to high temperature may not be safe to infuse.

•

Do not access SERVICE mode to adjust settings while the instrument is connected to patient.

•

Excessive or prolonged recirculation may damage red blood cells by exposing them repeatedly to the rollers inside the pump head.

•

Practice standard precautions when handling blood products. Treat all blood as if it were infected and clean up all spills immediately.

•

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.

•

Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.

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Chapter 2: Operation

Cautions •

If an IV pole is used, check that the system is securely clamped to the IV pole and will not tip over.

•

Do not pressurize the reservoir.

•

Do not apply a vacuum to the reservoir.

•

Ensure the tubing and the reservoir and the interlock block is not bent, kinked, or pulled too tight.

•

Immediately wipe any spills from the device.

•

Prime the main system with solutions compatible with blood products. Do not prime with blood or blood products.

•

A dedicated intravenous access site should be used for infusing blood components and solutions compatible with blood per AABB guidelines.

•

Replace reservoir chamber or disposable set if the filter becomes clogged. If it becomes occluded the fluid sensor will activate, an audible alarm will sound, a message "Fluid Out, Check inlet tubing and Filter. Add more fluid" will appear and the pump will stop.

•

Excessive or prolonged recirculation may damage red blood cells by exposing them repeatedly to the rollers inside the pump head.

•

Battery operation should be used only briefly or at very low flow rates because there is no heating.

•

With fluid in the disposable set and the system not powered on, keep the patient line clamped closed when opening the door to prevent uncontrolled fluid flow.

•

Do not infuse blood that is in the disposable set when over temperature condition occurs. Red cells that have been subjected to high temperature may not be safe to infuse.

•

Turn the system OFF and unplug the power cord before cleaning to avoid electric shock.

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Chapter 2: Operation

Compatible Fluids

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Chapter 2: Operation

STEP-BY-STEP OPERATING PROCEDURES SET-UP INSPECTING THE SYSTEM • • • •

Power cord Reservoir Support Disposable Set Large Reservoir and holder, if needed

Inspect the system to ensure that you have all necessary components. Ensure that circuit breaker is easily accessible to turn off in an emergency situation. Use only supplied power cord.

IV POLE MOUNTING

RESERVOIR SUPPORT

•

IV Pole: 5 wheel, maximum diameter 1 1/4"

•

Install the Support Assembly 30" from the ground, if not already installed.

•

Mount the Belmont® Rapid Infuser RI-2 on the IV Pole above the Support Assembly

•

Install the Reservoir Support app. 9" above the top of the system

SUPPORT CLAMP

OPTIONAL PLASTIC WASHER

1. DISCLAIMER: THE IV POLE IS NOT REQUIRED FOR USE; IT IS NOT CONSIDERED A CRITICALDETACHABLE COMPONENT AND ORDERING AN IV POLE FROM BELMONT IS OPTIONAL. CAUTION:

Install the support assembly (support clamp and washer) approximately 30" from the ground. •

While holding clamp closed, loosen the screw to open up the clamp. Install clamp on the IV pole, holding clamp close and tighten screw using the supplied 3/16 Allen wrench.

•

Optional: Snap the plastic washer onto the IV pole above the support clamp. Not all IV Poles are supplied with the plastic washer as it is optional and does not affect functionality.

If an IV Pole is used, check that the system is securely clamped to the IV pole and will not tip over 2.

Lift up on the “Pole Clamp Release Handle” to open. Mount the system onto the IV pole, above the support assembly, by pushing down on the pole clamp release handle. Check that the system is locked in place before proceeding.

3.

Clamp the reservoir support onto the IV pole approximately 9" above the Belmont® Rapid Infuser RI-2. •

Device Set-up without IV Pole

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Make certain that there is nothing obstructing the air vents at the bottom of the system.

1. Ensure all 4 feet are securely attached to the device 2. Place device on a sturdy, flat surface that will not obstruct the fan guards. 3. Ensure there is space to hang fluids bags above the reservoir to avoid kinked or twisted tubing. Belmont Medical Technologies

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Chapter 2: Operation INSTALLING THE DISPOSABLE SET

1. Snap reservoir chamber into the reservoir support clamp.

Store the disposable set, in the sealed original packaging, in a dry well-ventilated area free from exposure to chemical vapors.

2. Open the door. Insert heat exchanger with red arrow pointing up (Red tinted tubing to red stripe on unit.)

It is recommended to load and prime the disposable set just prior to the procedure. WARNING: The disposable set is for single patient use only. Do not reuse. Bag Clamps

3. Firmly position the interlock block into the fluid out detector.

4. Guide the curved piece of pump tubing (Blue tinted tubing) over the pump head. Check that the thinner recirculate line is in the grove to the right.

Air Vent

Bag Spikes Coarse Filter

Reservoir Chamber

Heat Exchanger Red Tinted Tubing Pressure Chamber

Check Valve

Do not kink or twist the tubing

Interlock Block

5. Place the pressure chamber into the pressure chamber well. Firmly insert the wider infuse line into the air detector and to the left of valve wand.

Pump Tubing Infuse Line

Recirculate Line

Roller Clamp

Do not apply excessive pressure to the pressure transducer. The pressure transducer can be damaged with excessive force. Do not use the system if the pressure transducer is damaged.

Patient Line

3-Spike Disposable set with key components

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6.

Place the thinner recirculate line to the right of the air detector, and to the right of the valve wand.

7.

Close and latch the door. Make certain the pump tubing is not caught. Connect the patient line.

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Chapter 2: Operation INSTALLING THE OPTIONAL LARGE RESERVOIR •

Install large reservoir holder

•

Install large reservoir

1.

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 in the luer lock tab and pulling out the connector.

•

Disconnect the thinner recirculate line by unscrewing the connector.

2.

Attach the large reservoir holder onto the IV pole, if used, and place the reservoir into the holder.

3.

Assemble the large reservoir using aseptic techniques by attaching the three fluid supply tails onto the top of the reservoir.

4.

Connect the large reservoir to the fitting of the 3Spike disposable set.

5.

Adjust the reservoir holder to make sure that the two connection leads underneath the reservoir are not stretched or kinked.

CAUTION: Do not pressurize the reservoir Do not apply a vacuum to the reservoir Ensure the tubing between the reservoir and the interlock block is not bent, kinked, or pulled too tight. Adjustment of the reservoir or reservoir holder may be needed.

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Stretched or kinked connection leads can cause flow restrictions and frequent Fluid Out alarms.

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Chapter 2: Operation POWERING ON THE SYSTEM • • •

• •

Check that the detachable power cable is securely seated in the main power receptacle. Check that the moisture guard is flush against the Rapid Infuser if present. Plug the system power cord into a grounded, 3-prong, 20 Amp, AC receptacle (120V device) or into appropriate grounded, 3-prong, minimum 10 Amp, AC receptacle (230V device) on a dedicated circuit breaker. Do not use an adaptor for ungrounded outlets. Ensure that circuit breaker is easily accessible to turn off in an emergency situation.

1. Plug system into a dedicated AC power source (breaker). 2.

Turn power on by firmly pressing the circuit breaker to the ON position. The system will perform a self-check to check the integrity of system parameters.

3.

Ensure AC POWER PRESENT appears at the logo screen when the system first powers up. Check the power cord and AC receptacle connections if the statement does not appear.

4.

PRIME screen will appear.

5.

Press NEXT to go to the PRIME screen. •

If screen language is not your preferred language, turn power off and back on.

•

Press SERVICE to go to CALIBRATION/SETUP screen.

•

Press LANG SETUP → choose your preferred language → NEXT → EXIT SERVICE.

•

If you turn power ON without the disposable set, INSTALLATION screen appears.

•

Open the door and follow instructions on screen to install the disposable set.

•

Close the door. PRIME screen will automatically appear.

Power-Up Screen

WARNING: The RI-2 should not be left unattended while in operation.

Installation Screen

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WARNING: Use a dedicated circuit breaker to avoid risk of supply interruption and for proper function of The Belmont Rapid Infuser RI-2. The Belmont draws maximum current under normal operating conditions and should be the only device operating on the circuit breaker.

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Chapter 2: Operation INSTALLING FLUID BAG

1.

Hang fluid bag(s) on the IV pole, if used.

Install solution compatible with blood for the main system prime.

2.

Completely close bag clamps and remove the bag spike cap(s). Spike the fluid bag(s), piercing it fully to ensure that fluids flow freely.

3.

Open bag clamps.

,

Prime Screen

•

When hanging the fluid bag above the machine, the pump tubing that is seated in the fluid out detector should not be stretched. Stretching the pump tubing may cause false Fluid Out alarms.

•

The recirculate line must not be kinked or restricted. The Belmont® Rapid Infuser RI-2, is not for use in warming platelets, cryo-precipitates, granulocyte suspensions, pharmaceutical agents, unprocessed whole blood. DO NOT combine any substances that contain calcium with blood products. This will cause clotting and occlusion of the unit and could cause overheating occurrence. Calcium-containing solutions, such as Lactated Ringer’s solution, Hartmann’s solution, dextrose in water, and hypotonic sodium chloride solutions, should not be added to blood components per AABB (American Association of Blood Banks). See the compatible fluids list on page 12. Caution: Prime the main system with solutions compatible with blood products. Do NOT prime with blood or blood products.

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Chapter 2: Operation PRIMING THE MAIN SYSTEM 2.

2.

System Priming Screen

The prime volume, 100 mL, countdown is displayed on the screen. Priming will stop automatically when countdown reaches 0 mL. SYSTEM PRIMED screen appears. •

If after 30 seconds the prime volume remains at 100 mL, the system will stop, alarm and instruct the user to unclamp the lines and resume prime.

•

If prime has to be stopped, press STOP. The prime volume countdown will remain on the screen. Press RESUME PRIME to continue prime.

CAUTION: Immediately wipe any spills from the device

PRIMING THE PATIENT LINE

Press PRIME to recirculate 100 mL of fluid at 500 mL/min to remove air and fill the main system with fluid.

To remove air from the patient line. 2.

2.

Open the roller clamp and remove the luer cap from the patient line.

Press PT. LINE PRIME Press once, prime at 50 mL/min. Press and hold, prime at 200 mL/min. 2.

Press STOP after no air remains in patient line.

System Primed Screen WARNING: Inspect and make certain that the patient line is completely primed and free of air. Any air bubbles after the valve wand in the patient line must be removed before the procedure can safely continue.

Patient Line Primed Screen

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Chapter 2: Operation CONNECTING TO THE PATIENT 1. Match infusion set to flow rate and fluid type, see chart.

Select an appropriate cannula size for desired flow rate.

2.

Using aseptic technique, make patient connection without entrapping air.

CAUTION: A dedicated intravenous access site should be used for infusing blood components and solutions compatible with blood per AABB guidelines.

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Chapter 2: Operation INITIATING INFUSION 2.

2.

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 ▼ key (increase/decrease by 10 mL/min).

Patient Line Primed and Infuse Screen

Do not mix solutions containing calcium such as Lactated Ringer’s, or Hartmann’s solution with citrated blood products. See the compatible fluids list on page 12. Use only anticoagulated blood products.

Infuse Screen

MAINTAINING INFUSION

Routinely check patient and system parameters on screen. Respond to and correct system alarms. Disposable set should be replaced after 24 hours of use. CAUTION: Replace reservoir chamber or disposable set if the filter becomes clogged. If it becomes occluded, the Fluid Out sensor will activate, an audible alarm will sound, and a message saying “Fluid Out, Check inlet tubing and Filter. Add more fluid” will appear, and the pump will stop.

Infuse Screen

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Chapter 2: Operation PRESSURE CONTROL Regulate the pump speed to keep line pressure under the user-set pressure limit.

The pressure limit is set at the factory to the maximum limit of 300 mmHg. Limit can be changed, see Chapter 4, page 37. While the system is under pressure control, the system displays “Infusing-Pressure Control. Press Set Rate to match Actual Rate” message, pressure status line flashes and a tone beeps at 10 second interval. Pressure control may be automatically initiated due mainly to the small orifice of the infusion set or any occlusions in the line.

Pressure Control Screen AUTOMATIC AIR PURGING

To eliminate the pressure control, press SET RATE key to match the actual rate that the system is able to maintain without alarming or use a properly sized cannula for the desired flow rate and fluid type. See chart to match infusion set to flow rate and fluid type, page 19.

After every 500 mL of fluid infused, the system automatically purges air from the system by closing the infusion line and opening the recirculation line for a few seconds. The recirculate rate is temporarily set to 500 mL/min, if the flow rate is at or below 500 mL/min, and at the actual flow rate, if the flow rate is above 500 mL/min. The RATE status line displays REMOVING AIR during this process. The volume readout (VOL) remains unchanged during automatic air purging and resumes counting when infusion resumes.

Automatic Air Purging Screen

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When infusion resumes, the system returns to the previously set rate.

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