Belmont Medical Technologies BUDDY LITE AC Operator's Manual

Blood/fluid warmer

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BUDDY LITE

BLOOD/FLUID WARMER

OPERATOR'S MANUAL

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Page 1 ® BUDDY LITE BLOOD/FLUID WARMER OPERATOR’S MANUAL...
Page 2 BUDDY LITE BLOOD/FLUID WARMER OPERATOR’S MANUAL CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Belmont Medical Technologies 780 Boston Road All service calls & questions Billerica, MA 01821, USA should be directed to:...
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………………………………………………………………………………………………………. Indications for Use and Contraindications………………………………………………………..………….. System Overview……………………………………………………………………………………………….. System and Temperature Monitoring………………………………………………………….….………….. Information Signals……………………………………………………………………...……………..……….. Battery Pack………………………………………………………………………………………….…………..
Page 4: System Overview
Chapter System Overview I N T R O D U C T I O N : ® The buddy lit AC 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 (3.0 L/hr) for packed red cells at 10°C.
Page 5 WARNING The control system can only be used with the Belmont supplied disposable. Do not alter the disposable, Heater Unit, or battery pack or AC/DC supply. Use only with crystalloid or anticoagulated blood products. Do not use in the presence of flammable anesthetics. CAUTION The system should not be used with pressure infusers.
Page 6: System And Temperature Monitoring
The AC/DC supply is a medical switch-mode power supply with universal 100VAC – 240VAC input, and an 18 VDC output. It connects to the housing via an AC Adapter. The disposable set has a sterile fluid path and is Check Valve intended for single-use only.
Page 7: Battery Pack
B A T T E R Y P A C K ® The Battery Housing of the buddy lite AC Blood/Fluid Warmer is shown below: ON/OFF Switch Adapter 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 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 buddy lite AC Blood/Fluid Warmer to ensure safe and effective operation of the system. CAUTION: Use of this device requires detailed familiarity with its operating procedures.
Page 9 WARNINGS: Use only the Belmont supplied disposable. The disposable set is a single- use, sterile, non-pyrogenic Blood/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 Procedures
Step-by-step summary of operating procedures Operating Steps Detailed Information Set-up Make sure that you have all the necessary supplies. Make sure that the battery is • fully charged, 5-segment shown on the battery LCD or 4 LED if using alternate battery. If battery needs to be recharged, see the “Charging Procedure”, at the end of this section.
Page 11: 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. Connect the fluid administration •...
Page 12: Establish Power To The Heater Unit
Operating Steps Detailed Information Establish Power to the Heater Unit If AC/DC power is needed, plug the AC/DC input to the wall outlet and the output to the AC adapter on the A/C Adaptor battery housing. Depress the Heater Unit ON/OFF switch, on the battery Disposable Set housing, to supply power to the...
Page 13: 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 power is ON. You may see some condensation around the outer edge of The GREEN LED, on the •...
Page 14: Flow Characteristics
F L O W C H A R A C T E R I S T I C S ® The buddy lite AC Blood/Fluid Warmer is designed for gravity flow. The maximum flow rates achievable will be determined by the size of the catheter employed. The disposable has been designed to withstand up to 300 mmHg infusion pressure, provided the disposable set is within the Heater Unit and latched.
Page 15: Information Signals And Troubleshooting
I N F O R M A T I O N S I G N A L S A N D T R O U B L E S H O O T I N G The chart below details information signals, the system response and the recommended user actions.
Page 16: Introduction
Chapter Service and Maintenance I N T R O D U C T I O N The buddy lite ® AC Blood/Fluid Warmer has no internal user serviceable parts and does not require calibration except for the battery fuel gauge. Routine maintenance consists of cleaning and inspecting the Heater Unit, recharge the battery after each use, recalibrate the battery fuel gauge, and testing the system operational.
Page 17: 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. 1.
Page 18: Charging The Battery
3. Charging the battery: (If using alternate charger, 50 Watt SMBUS desktop mini battery charger by RRC Power Solutions, refer to section 3.2 instruction) Charger with recalibrator Material required: Charger/Calibrator (Calibrator not included with 12V Charger) • 24V 2.5A DC power supply with universal mains input (90 to 260 VAC) •...
Page 19: Charger
Recharge Time: It will take approximately 2.5 hours from fully discharged to fully charged. 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.
Page 20 Procedure: a. Place the “Charger” on a flat, level surface away from sources of heat and moisture. b. Plug the DC connector from the power supply into the back of the charger. c. Connect the power supply to the mains AC supply. d.
Page 21: System Operational Checkout
SYSTEM OPERATIONAL CHECKOUT This system operational checkout including the information signal 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 22: Electromagnetic Compatibility
ELECTROMAGNETIC COMPATIBILITY The buddy lite ® AC 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 IEC ®...
Page 23: Technical Specifications
Chapter Technical Specifications DIMENSIONS Size Battery Housing: 3.33" x 7.26" x 1.36" (W x L x H) AC/DC supply: 4.25” x 8.4” x 1.85” 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 AC/DC supply: 2.64 lbs.
Page 24 OPERATING PARAMETERS Flow Rate Input temperature 20°C: Max 80 ml/min Input temperature 10°C: Max 50 ml/min Output Temperature: 38º ± 2ºC 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 25 CLASSIFICATION Type of Protection Against Electrical Class II Shock Degree of Protection Against Electric CF defibrillator-proof Shock Degree of Protection Against Harmful On battery power: IP54, Protected against water splashes Ingress of Water On AC power: IPX1, Drip proof Degree of Safety in Presence of Not suitable Flammable Anesthetics Mode of Operation...
Page 26 SYMBOLS AND DEFINITIONS Symbol Description Compliance to Medical Device Directive 93/42/EEC as amended by 2007/47/EC Attention, consult accompanying documents/refer to manual Defibrillator-proof type CF equipment Protected against dripping water IPX1 Protected against 1mm or larger objects and water IP54 splashes Serial Number Do not immerse into water or any other liquid Manufactured by...
Page 27: Ordering Information
To order parts for the buddy lite buddy lite ® ® ® ® AC Blood/Fluid Warmer System, call or write to the following: buddy lite buddy lite Belmont Medical Technologies 780 Boston Road Billerica, MA 01821, USA USA: 855.397.4547 Worldwide: +1.978.663.0212 WWW.BELMONTMEDTECH.COM...

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