Belmont buddy lite Operator's Manual

Belmont buddy lite Operator's Manual

Blood/fluid warmer

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Blood/Fluid Warmer
Operator's Manual
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician
Belmont Instrument Corp.
780 Boston Road Billerica MA 01821 USA
USA Technical Support 855-397-4547
Fax 978-663-0214
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: +31 (0) 70 345 8570
Fax: +31 (0) 70 346 7299
702-00091/Rev M

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Summary of Contents for Belmont buddy lite

  • Page 1 Blood/Fluid Warmer Operator’s Manual Belmont Instrument Corp. 780 Boston Road Billerica MA 01821 USA USA Technical Support 855-397-4547 Fax 978-663-0214 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Tel: +31 (0) 70 345 8570 Fax: +31 (0) 70 346 7299...
  • Page 2: Table Of Contents

    Table of Contents C H A P T E R 1 : S Y S T E M O V E R V I E W Introduction………………………………………………………………………………………….. Indications for Use and Contraindications……………………………………………………….. System Overview…………………………………………………………………………………… System and Temperature Monitoring………………………………………………………….…. Alarms and Alarm Messages……………………………………………………………………... Battery Pack………………………………………………………………………………………….
  • Page 3: Introduction

    Chapter System Overview I N T R O D U C T I O N : The Belmont buddy lite in-line Blood/Fluid warmer is a miniature portable fluid warmer and ® ™ sensing device that warms intra-venous fluids (including blood products) to physiological temperature at flow rates up to 80 ml/min (4.8 L/hr) for crystalloids at 20°C and up to 50 ml/min...
  • Page 4: System Overview

    WARNING The control system can only be used with the Belmont supplied disposable. Do not alter the disposable, Heater Unit, or battery pack. Use only with crystalloid or anticoagulated blood products. Do not use in the presence of flammable anesthetics.
  • Page 5: System And Temperature Monitoring

    (INPUT ) that is generated during heating, see Figure 2. Figure 2: The buddy lite Disposable Set ™ The set is color-coded and keyed to ensure proper placement in the Heater Unit, blue at the input from a fluid administration set.
  • Page 6: Battery Pack

    B A T T E R Y P A C K The Battery Housing of the Belmont buddy lite Blood/Fluid Warmer is shown below: ™ ® Strain ON/OFF Relief Switch Blue/Red Battery Housing Battery 5 Segment LCD Figure 3: Battery in the Battery Housing POWER The battery capacity is displayed via a 5-segment LCD panel on the battery pack.
  • Page 7: Introduction

    Chapter Operation of the System I N T R O D U C T I O N This section reviews the set up and operation of the Belmont buddy lite Blood/Fluid Warmer to ™ ® ensure safe and effective operation of the system.
  • Page 8 WARNINGS: Use only the Belmont supplied disposable. The disposable set is a single-use, sterile, non-pyrogenic fluid path. Do not change or alter the disposable. Use extreme caution when handling the disposable; do not expose the disposable to sharp objects. Do not use in the presence of flammable anesthetics.
  • Page 9: Step-By-Step Summary Of Operating Procedures

    S T E P - B Y - S T E P S U M M A R Y O F O P E R A T I N G P R O C E D U R E S Operating Steps Detailed Information Set-up...
  • Page 10: Connect To Fluid Bag And Administration Set

    Operating Steps Detailed Information The Heater Unit will not close if the disposable is not installed properly. BLUE (INPUT ) Close and latch the case. Connect to the Fluid Bag and Administration Set • Hang a fluid bag and administration set. •...
  • Page 11: Initiate Infusion

    Operating Steps Detailed Information Establish Power to the Heater Unit Depress the ON/OFF switch, on the battery housing, to supply power to the Heater Unit. Blue LED turns ON and Red LED flashes once, if the Heater Unit is functioning normally. If not, return for service.
  • Page 12: End Of Procedure

    Operating Steps Detailed Information Maintain Infusion • Observe the LED, on the battery housing. The LED is There are no adjustments on the Heater Unit. BLUE when the battery power is ON. You may see some condensation around the outer-edge of •...
  • Page 13: Flow Characteristics

    F L O W C H A R A C T E R I S T I C S The Belmont buddy lite Blood/Fluid Warmer is designed for gravity flow. The maximum ™ ® flow rates achievable will be determined by the size of the catheter employed.
  • Page 14: Operational Alarms And Troubleshooting

    O P E R A T I O N A L A L A R M S A N D T R O U B L E S H O O T I N G The chart below details alarm conditions, the system response and the recommended user actions.
  • Page 15: Introduction

    The heater plates in the Heater Unit are sealed. Inspect the seals to insure their integrity after each use. If the seal is not intact, do not use. Do not try to open or to service the Heater Unit. WARNING Do not submerge the buddy lite system. ™...
  • Page 16: Cleaning, Disinfection, And Maintenance

    C L E A N I N G , D I S I N F E C T I O N A N D M A I N T E N A N C E ROUTINE MAINTAINENCE Turn the ON/OFF switch to OFF. Clean and/or Disinfect Exterior: Battery Housing The housing may be wiped down with water or a 10% bleach solution using a...
  • Page 17: Charging The Battery

    Charging the battery: Material required: • Charger/Calibrator • 24V 2.5A DC power supply with universal mains input (90 to 260 VAC) • Mains cable Figure 4: Battery Charger and Calibrator Power Supply Calibration button Status window Procedure: Place the “Charger and Calibrator” on a flat, level surface away from sources of heat and moisture.
  • Page 18: Re-Calibrate The Fuel Gauge

    Recalibrate the Battery Fuel Gauge: If the battery fuel gauge needs to be recalibrated, the red LED indicator, on the battery charger, will flash. The recalibration is used to ensure the reliability of the battery capacity. Procedure: Place the battery into the battery charger bay ensuring that the 5-way connector is fully seated.
  • Page 19: System Operational Checkout

    SYSTEM OPERATIONAL CHECKOUT This system operational checkout including the alarm test should be done periodically. Prior to performing the test, have the following equipment and supplies on hand: • Saline or other crystalloid for testing • Disposable Set • Administration set •...
  • Page 20: Electromagnetic Compatibility

    80 IEC 61000-4-3 single frequency. MHz to 2.5 GHz Power Frequency If interference occurs, it may be Magnetic Field necessary to position the buddy lite 3 A/m Immunity further from sources of power frequency IEC 61000-4-8 magnetic field.
  • Page 21: Technical Specifications

    Chapter Technical Specifications DIMENSIONS Size Battery Housing: 3.33” x 7.26” x 1.36” (W x L x H) Battery: 3.1” x 5.9” x 0.89” Heater Unit: 1.5” x 5.2” x 0.87” Weight Battery Housing : 4.4 oz Battery: 0.97 lbs Heater Unit: 3.5 oz POWER Battery Nominal Voltage...
  • Page 22 OPERATING PARAMETERS Flow Rate Input temperature 20°C: Max 80 ml/min Input temperature 10°C: Max 50 ml/min Output Temperature: 38° ± 2°C Prime Volume 4 ml without tubing, 7.5 ml with valves and tubing at the input and output OPERATING PANEL Control Keys (On Battery Housing On/off Switch –...
  • Page 23 CLASSIFICATION Type of Protection Against Electrical Class II Shock Degree of Protection Against Electric CF defibrillator-proof Shock Degree of Protection Against IPX1, Drip proof Harmful Ingress of Water Degree of Safety in Presence of Not suitable Flammable Anesthetics Mode of Operation Continuous Medical Equipment Medical –...
  • Page 24 SYMBOLS AND DEFINITIONS Symbol Description Compliance to Medical Device Directive 93/42/EEC Attention, consult accompanying documents/refer to manual Defibrillator-proof type CF equipment IPX1 Protected against dripping water Serial Number Do not immerse into water or any other liquid Manufactured by Authorized European Representative...
  • Page 25: Ordering Information

    Chapter Ordering Information The Belmont ® buddy lite ™ Blood/Fluid Warmer System, European P/N 905-00016 The Belmont ® buddy lite ™ Blood/Fluid Warmer System, N. America P/N 905-00017 The Belmont ® buddy lite ™ Blood/Fluid Warmer System, UK P/N 905-00018 The Belmont ®...

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