Belmont buddy 2 Operator's Manual
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Belmont buddy 2 Operator's Manual

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  • Page 1 buddy™2...
  • Page 2 BELMONT INSTRUMENT C ORPORATION ‘ ’ buddy Blood/Fluid Warmer Operator’s Manual Belmont Instrument Corp. 780 Boston Road Billerica, MA 01821 EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Tel +31(0) 70 345 8570 Fax +31(0) 70 346 7299...

  • Page 3: 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…………………………………………………………………………………….. 1 Indications for Use and Contraindications……………………………………………………….. 1 System Overview………………………………………………………………………………… 2 System and Temperature Monitoring………………………………………………………….…. 3 Alarms and Alarm Messages……………………………………………………………………...

  • Page 4: Introduction

    Chapter System Overview I N T R O D U C T I O N : The Belmont buddy™2 in-line Blood/Fluid Warmer combines advanced microprocessor ® technology with an efficient heating system to provide a safe and simple system for low flow fluid warming in a miniature package.

  • Page 5: System Overview

    WARNING The control system can only be used with the Belmont supplied disposable. Do not alter the disposable, Heater Unit or Power Module. Use only with crystalloid or anticoagulated blood product. Not for infusion of drugs Do not use in the presence of flammable anesthetic.

  • Page 6: System And Temperature Monitoring

    The disposable set has a sterile fluid path, and is intended for single use only. The disposable set has standard luer connectors and can be connected to any standard catheter. It contains two thin films, which contact the heater plates BLUE (INPUT ) for rapid heating of the fluid, and...

  • Page 7: Control Panel: Display And Keys

    C O N T R O L P A N E L : D I S P L A Y A N D K E Y S The Power Module of the Blood/Fluid Warmer is shown below: buddy™2 POWER The display is illuminated when the unit is plugged into the AC outlet.

  • Page 8: 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™2 Blood/Fluid Warmer ® to ensure safe and effective operation of the system.
  • Page 9 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 10: Step-By-Step Summary Of Operating Procedure

    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 11: Connecting The Heater Unit

    Operating Steps Detailed Information Connect Heater Unit to Power Module Heater Unit Connect the to the Power Module by aligning the dot Align the dot on receptacle to the pointed line To the pointed line on the plug. To disconnect, twist the plug toward the arrow to release.

  • Page 12: Connect To Fluid Bag And Administration Set

    Operating Steps Detailed Information Heater Unit will not close if the disposable is not installed properly. BLUE (INPUT ) P AT IENT MALE LUE R Close and latch the case. FEMALE LUE R CONNECT T O FLUID Connect to the Fluid Bag and Administration Set ...

  • Page 13: Initiate Infusion

    Operating Steps Detailed Information  Select appropriate Initiate Infusion catheter size intended flow rate.  Using aseptic technique, make patient connection without entrapping air.  P AT IENT Adjust the roller clamp to the desired flow rate. MALE LUER  Heater Unit Secure the in a horizontal position,...

  • Page 14: End Of Procedure

    Operating Steps Detailed Information  Clamp roller clamp on the End of Procedure administration set off.  Clamp the input end of disposable set off using the blue slide clamp.  Heater Unit Turn off by pressing ON/STANDBY button power module.

  • Page 15: Flow Characteristics

    F L O W C H A R A C T E R I S T I C S The Belmont Blood/Fluid Warmer is designed for gravity flow. The maximum flow buddy™2 ® rates achievable will be determined by the size of the catheter employed.

  • Page 16: 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 Belmont Blood/Fluid Warmer detects and displays the following alarm ®...
  • Page 17 Alarm Message Condition and System Probable Causes Actions Response Low Temperature System detects fluid Flow rate is set too fast. Slow the flow rate using roller clamp on the temperature below 31C for administration set. 10 sec. Display message, no audible alarm.
  • Page 18 Alarm Message Condition and System Probable Causes Actions Response **System Reset Internal computer Loose watchdog Unplug power malfunction. Alarm function on the Power module from wall continuously and display Module Processor. outlet, and re-power. If message. not successful, call service. ** At these four (4) alarms, system stops heating, flashes a red LED, alarms, and displays message.
  • Page 19 U S E R M A N A G E M E N T O F A L A R M S To silence an audible alarm, depress the ALARM MUTE key. If the alarm condition persists, the audible alarm will resume after 60 seconds, except the EMPTY SET/CHECK FOR AIR alarm, which will remain disabled until air disappears and flow resumes for at least 1 minute after which it can again be activated automatically.

  • Page 20: Introduction

    Chapter Service and Maintenance I N T R O D U C T I O N The Belmont Blood/Fluid Warmer has no user serviceable parts, and does not require ® buddy™2 calibration. Routine maintenance consists of cleaning and inspecting the Heater Unit after each use and testing the system operational and routinely test for leakage current to ensure against electrical shock hazard.

  • Page 21: 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 heater to STANDBY, unplug the power cord from the wall outlet. Clean and/or Disinfect Exterior: Power Module The Power Module may be wiped down with water or a 10% bleach solution...

  • Page 22: 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 supplied on hand:  IV Pole  Saline or other crystalloid for testing  Disposable Set ...

  • Page 23: Periodic Maintenance

    PERIODIC MAINTENANCE An electrical safety test should be performed at least once a year by a qualified technician. Prior to performing the electrical safety test, have the following equipment and supplied on hand:  Electrical Safety Analyzer  Saline or other crystalloid for testing ...
  • Page 24 Patient Leakage Current Install the disposable set. Attach 12 to 16 gauge stainless steel catheter to the end of the disposable set tubing. Install saline solution and the administration set. . Open the roller clamp and adjust for maximum flow. Turn the Safety Analyzer power on.

  • Page 25: Electromagnetic Compatibility

    ELECTROMAGNETIC COMPATIBILITY ® buddy™2 The Belmont is intended for use in the electromagnetic environment specified below. You should assure that it is used in such environment. Test Compliance Electromagnetic environment - guidance RF emissions, CISPR 11 Harmonic emissions may emit electromagnetic energy so...

  • Page 26: Technical Specifications

    Chapter Technical Specifications DIMENSIONS Size (W x H x D) Power Module: 4.33” x 7.48” x 2.39” AC/DC Supply: 4.25” x 8.42” x 1.85” Heater Unit 5.1” x 0.89” x 1.7” Weight Power Module: 1.00 lbs AC/DC Supply: 2.65 lbs Heater Unit 3.5 oz POWER...
  • Page 27 ENVIRONMENTAL Operating Temperature 10° to 35°C Relative Humidity 10% to 90% RH Pressure 49 to 103 kPa Storage Temperature -10° C to 40°C Shock and Vibration ISTA Pre-shipment Test Procedure, Test procedure 1, 1996 Electromagnetic Compatibility EN 60601-1-2 OPERATING PARAMETERS Flow Rate Input temperature 20°C: Max 100 ml/min Input temperature 10°C: Max 50 ml/min...
  • Page 28 SAFETY AND MONTORING Infusate Temperature Heater power shut off if fluid temperature exceeds specified limits Independent Safety Circuit Shut off the heater if temperature exceeds a limiting value ALARMS/ALERTS System Status (Alert, no audible LOW FLOW alarm) LOW TEMPERATURE Operator Setting, User Correctable EMPTY SET/CHECK FOR AIR (Alarm and display message) NO HEAT, CHECK CONNECTION...
  • Page 29 CLASSIFICATION Type of Protection Against Electrical Class I 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 30 SYMBOLS AND DEFINITIONS Symbol Description Compliance to Medical Device Directive 93/42/EEC and 2011/65/EU Alternating current Attention, consult accompanying documents/refer to manual Defibrillator-proof type CF equipment IPX1 Protected against dripping water Serial Number Class I equipment: the protection against electric shock is provided by a combination of basic insulation and the use of the EARTH connection Do not immerse into water or any other liquid...

  • Page 31: Ordering Information

    Chapter Ordering Information To order buddy System and the Disposable Set call or write the following: Belmont Instrument Corporation 780 Boston Road Billerica, MA 10821, USA (866) 663-0212 US/Canada (978) 663-0212 Worldwide (978) 663.0212 Email: sales@belmontinstrument.com REF: 905-00037 buddy™2 System, 100-240 VAC, English...

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