Gaymar FW400 Operator`s Manual
Contents
1. FW400 Series 50 48 46 44 o e 42 SA e 2 38 KI 36 34 32 30 0 50 100 150 200 250 300 Flow ml min Figure 6 Typical fluid temperature vs flow values 4 3 Control Alarm hl oa GAYMAF H a fluid temperature over 45 C is sensed by the Warmer it turns the heaters off and activates an audible alarm The display will alternately indicate the word hl and the temperature The audible alarm may be silenced during this condition by turning the unit off then on again H the fluid temperature drops below 45 C the unit will resume normal operation Refer to section 5 1 page 8 4 4 Over Temperature Safety Thermostats em GAYMAF In the event of Warmer failure there are two mechanical thermostats that will interrupt power to the heaters The first thermostat will turn off the heaters activate the audible alarm and turn the display blank The second thermostat will interrupt power to the Warmer if the first one fails Cold fluid through the Warming Set can be used to reset the thermostats The unit must be turned off then back on to reset the alarm circuits Refer to section 5 1 page 8 4 5 Control Alarm LO o Gre GAYMAR H the sensed fluid temperature drops below 34 C the Warmer will activate an audible alarm and the display will alternately indicate the word LO and the temperature Refer to section 5 1 page 8 Operator s Manual FW402. Flexible Cassette Male Luer to Patient Manual Air Eliminator F Female Luer to Relief Valve Blood Fluid Source Bubble Trap G Blue Guide Rail o fom Figure 2 Medi Temp II FW400 Series Blood Fluid Warmer Standard Warming Set Operator s Manual FW400 Series Blood Fluid Warmer Instructions for Use Setup Figure 3 Operator s Manual FW400 Series Blood Fluid Warmer 3 0 Instructions for Use Setup Stretch the flexible cassette slightly and insert the j front end into the front of the Warmer aligning the Select a site for placement of the Warmer If the Warmer is rails to each edge of the slotted opening attached to a pole ensure the pole clamp is securely l tightened Move hands to the rail protrusions and continue to insert the cassette until the clear guide rail is flush CAUTION with the front of the unit The blue guide rail will protrude slightly for easy removal Do not attempt to transport the f Warmer while mounted to an IV pole Close Warming Set input clamp Remove the protector It could tip over Remove the Warmer from the female luer of the Warming Set and connect for transport it to the male luer on the IV administration set Remove the protector from the male luer of the Plug the power cord into a properly grounded electrical outlet Warming Set To minimize temperature drop and ae priming volume remove unnecessary lead extensions NO
3. understand this Operators Manual and the SAFETY PRECAUTIONS prior to each application If you have any questions please contact your local dealer for assistance Warranty The Medi Temp II FW400 Series Blood Fluid Warmer is warranted free of defects in material and workmanship for a period of one 1 year The Disposable Warming Sets are warranted free of defects in material and workmanship for a single application A copy of the warranty is available upon request Gaymar disclaims all implied warranties including but not limited to the implied warranties of merchantability and of fitness for a particular purpose Medi Temp II is a trademark of Gaymar Industries Inc 2000 Gaymar Industries Inc All rights reserved www gaymar com Operator s Manual FW400 Series Blood Fluid Warmer 1 0 Indications for Use This device is intended to aid in the prevention of inadvertent hypothermia during administration of blood blood products and other fluids Ab 1 1 Safety Precautions DANGER Risk of electric shock Refer servicing to qualified medical service personnel WARNING All air must be removed from the fluid lines prior to connection to the patient Monitor the fluid lines to insure they are air free Never administer fluids if there are air bubbles in the line between the bubble trap and the patient connector Monitor the fluid level in the bubble trap frequently Bubbles released during heating ar
4. 0 Series Blood Fluid Warmer 5 0 Troubleshooting and Maintenance 5 1 Troubleshooting and Servicing Use the following checklist to identify and solve Warmer problems If after following these guidelines the problem persists have unit serviced by a qualified medical service person in accordance with the Medi Temp I FW400 Series Blood Fluid Warmer Service Manual contact your local dealer or Gaymar to obtain the Service Manual On off circuit breaker is not lighted Display indicates a flashing hl and audible alarm is activated Display is off on off circuit breaker is lighted and audible alarm is either on or off Display indicates a flashing LO and audible alarm is activated Display indicates ER2 e Check if on off circuit breaker is on e Check if power cord is securely attached and plugged in e Service required Send unit for servicing OVER TEMPERATURE CONDITION e An alarm may occur if the Warmer has been turned on prior to inserting a Warming Cassette 1 Turn unit off 2 Insert Warming Set and prime the Set 3 Turn unit back on e An alarm may occur if flow rate is stopped abruptly 1 Silence the alarm by turning the on off circuit breaker off then on again 2 Restart flow of fluid to reduce sensor temperature Proceed with use when the indicated sensor temperature is under 45 C e ifan alarm condition persists remove from use Send unit for servicing OVER TEMPERATURE CONDITIO
5. GAYMAT Medi Temp II FW400 Blood Fluid Warmer FW401 Blood Fluid Warmer REF FW403 Blood Fluid Warmer R chauffeur de sang liquide REF FW403 FRANGAIS Riscaldatore per sangue fluidi REF FW403 ITALIANO Recalentador de sangre y fluidos REF FW403 ESPANOL Aquecedor de Sangue Liquidos REF FW403 PORTUGUES REF FW403 Blut Flussigkeitswarmer DEUTSCH REF FW403 Bloed vloeistofverwarmer NEDERLANDS REF FW403 Varmeaggregat til blod veeske DANSK REF FW403 Varmeaggregat f r blod vatska SVENSKA REF FW403 Veren nesteenlammitin SUOMI REF FW403 Blod vaskevarmer NORSK Lvotnwa O epuavons Atwatoc Yypav REF FW403 EAAHNIKA Operator s Manual Manuel d utilisation Manuale per l operatore Manual del operador Manual do Utilizador Bedienungshandbuch Bedieningshandboek Operat h ndbog Operat rshandbok K ytt j n K sikirja Brukerhandbok 0086 Eyxe pi ro Xphong P N 11080 000 12 00 Operator s Manual FW400 Series Blood Fluid Warmer Table of Contents Section Description Page 1 0 Indications for Use Safety Precautions 1 2 0 Product Description ccccceseeseeeeeeens 2 3 0 Instructions fOr USE c eeeeeeeeeeseeeeeees 5 4 0 Safety Systems n se 7 5 0 Troubleshooting and Maintenance 8 6 0 Technical Specifications cccecceeeeeeeees 9 Before you begin A Important Before using the Medi Temp Il FW400 FW401 REF FW403 FW400 Series Blood Fluid Warmer please read and
6. N e Backup thermostats were activated 1 Reduce flow rate 2 Turn power off 3 Run cold fluid through the Warming Set to reset the thermostat with power off 4 Turn power on e H condition reoccurs remove Warmer from use and send for servicing If condition doesn t reoccur it may have occurred due to excessively high flow rate with very cold fluid LOWER TEMPERATURE CONDITION e An alarm may occur if a very high flow of cold fluid is present The alarm should last no more than 20 seconds e H alarm is continuous heater circuit may be inoperative Remove from use Send unit for servicing Temperature sensor has failed Remove from use Send unit for servicing Operator s Manual FW400 Series Blood Fluid Warmer 5 2 Cleaning bottom to facilitate cleaning Use the thin brush supplied with the Warmer to clean the inside of slot Rinse slot with CAUTION warm water Wipe Warmer dry with a clean dry cloth Do not immerse Warmer in cleaning and or sterilization solution Do not submerge or soak unit Apply a disinfectant such as 10 chlorinated bleach it is fluid resistant not fluid proof solution chlorinated bleach with 5 25 sodium hypochlorite to the external surfaces of the Warmer and allow to dry Perform the following care and cleaning between patient use or per hospital protocol 5 3 Function Check Unplug unit prior to cleaning A function check should be performed every three 3 To clean the exter
7. TE Do not turn unit on without first inserting a at this time Warming Set Doing so may activate the Over Temperature Safety Thermostats Also do not prime met the bubble trap the Warming Set prior to inserting it into the Warmer Open Warming Set input clamp Allow fluid to prime the Set Follow the instructions below see corresponding f illustrations numbered 1 through 8 on page 4 When the bubble trap fills to approximately two thirds 2 3 full close output clamp NOTE Warming Sets are designed for use below SS 300 mm Hg 5 Re invert the bubble trap and mount it in the bubble trap holder so it is in a vertical position 1 Remove the Warming Set from its sterile packaging WARNING WARNING The bubble trap must be mounted and kept in Do not use the contents of the package if any the vertical position at all times Failure to do part of the contents is damaged distorted or so could result in the introduction of air to the contaminated Contents are sterile and non patient The introduction of air to the patient pyrogenic in unopened undamaged package could result in death or serious injury NOTE The flexible cassette is designed so it can be inserted into the Warmer in only one orientation see O Turn the on off circuit breaker on The Warmer will figure 1 page 2 The blue guide rail on the cassette perform a two second self check before turning on lines up with the blue guide rail indicator on t
8. e captured in the trap To refill the trap insert a sterile syringe into the valve and draw air out until the trap is two thirds 2 3 full Do not allow the bubble trap to go below one quarter 1 4 full See figure 5 page 6 The bubble trap must be mounted and kept in a vertical position at all times Failure to follow the above warnings could result in the introduction of air to the patient Introduction of air to the patient could result in death or serious injury WARNING e Repairs should be performed only by qualified medical service personnel in accordance with this product s service manual Otherwise damage to the Blood Fluid Warmer and improper therapy may result CAUTION U S Federal law restricts this device to sale by or on the order of a physician Do not immerse in cleaning and or sterilization solution Do not submerge or soak unit it is fluid resistant not fluid proof For grounding reliability of the Blood Fluid Warmer plug only into a properly grounded outlet Do not attempt to transport the Blood Fluid Warmer while mounted to an IV pole It could tip over Remove the Blood Fluid Warmer for transport Operator s Manual FW400 Series Blood Fluid Warmer 2 0 Product Description The Medi Temp II FW400 Series Blood Fluid Warmer is a simple dry heat device designed for safe and rapid in line warming of blood blood products and other fluids through the utilization of disposable Blood F
9. he front the display of the Warmer If required connect an extension for patient Grasp each rail see figure 4 below with the blue connection guide rail in the left hand Purge air from remaining length of tubing by opening output clamp and allowing fluid to flow WARNING Air must be removed from the fluid lines prior to connection to the patient Failure to do so A IN N could result in the introduction of air to the CA INA patient The introduction of air to the patient H EOS could result in death or serious injury Figure 4 Grasp and stretch flexible cassette Operator s Manual FW400 Series Blood Fluid Warmer 3 1 During Use 3 2 Warming Set Removal The flexible cassette of the Warming Set cannot be removed WARNING from the Warmer when there is fluid within it e Monitor the fluid lines to insure they are air free 1 Drain the Warming Set of fluid Never administer fluids if there are air bubbles in the line between the bubble trap and the patient 2 Remove bubble trap from holder connector 3 Pull blue guide rail to remove flexible cassette from Monitor the fluid level in the bubble trap frequently Warmer Bubbles released during heating are captured in 4 Dispose of Warming Set per hospital protocol the trap Do not allow the bubble trap to go below one quarter 1 4 full Air can be removed from the bubble trap by inserting a sterile syr
10. inge into the Manual Air Eliminator see figure 2 page 3 and withdrawing air until the trap is two thirds 2 3 full See figure 5 below Failure to follow the above warnings could result in the introduction of air to the patient Introduction of air to the patient could result in death or serious injury t F Ay 5 j gei Figure 5 Monitoring Fluid Level During normal operation the Warmer will indicate approximately 43 0 C on its display If the audible alarm sounds during operation the Warmer may not be heating Refer to section 4 0 Operator s Manual FW400 Series Blood Fluid Warmer N 40 4 1 Electronic System Self Check Each time the Warmer is turned on it performs a self check about 2 seconds before lighting the display If a problem is detected an error code will be displayed and the Warmer must be removed from use Safety Systems az GAYMAF 4 2 Temperature Control The Medi Temp II FW400 Series Blood Fluid Warmer noninvasively senses fluid temperature on the surface of the Warming Cassette At steady state the Warmer indicates approximately 43 0 C on its display Output fluid temperature will be 36 C 43 C for 10 C input fluid temperature Fluid temperature is affected by fluid flow rate as shown in figure 6 below Room temperature fluid may be warmed at flow rates up to 500 ml min Typical Fluid Temperature
11. isposable Warming Sets see figure 2 The Medi Temp II FW400 Series Blood Fluid Warmer is designed to be used with Gaymar D25000 Series Blood Fluid Warming Sets only The following Blood Fluid Warming Sets are available for use at this time Check with your local dealer for more details Each Warming Set consists of a flexible cassette for insertion into the warmer and a bubble trap with a manual air eliminator They are designed for use below 300 mm Hg pressure with hospital standard intravenous IV administration sets and venipuncture sets utilizing luer type connectors Each Warming Set also has input and output pinch clamps See figure 2 The Standard Warming Set is designed for use at 300 ml min or lower flow rates The Standard Warming Set with Extensions provides the user with added patient lead length The priming volume of the Standard Warming Set is 39 ml The priming volume of the Standard Warming Set with Extensions is 48 ml The Pediatric Warming Set has a lower priming volume of 30 ml Its patient connection lead utilizes thicker walled tubing to provide added insulation at the lower pediatric warming flow rates The High Flow Warming Set uses leads having a larger inner diameter This reduces restriction during circumstances requiring rapid infusion The priming volume of the High Flow Warming Set is 79 ml Standard with Extensions D25310CE Standard with Extensions 60 D25315CE High Flow D25330CE
12. luid Warming Sets The Warmer does not provide fluid flow rate control Blood blood products and other fluids at temperatures 10 C and below will be warmed to temperatures between 36 C and 43 C at flow rates of 10 to 300 ml min Room temperature fluids 20 C can be warmed at flow rates up to 500 ml min The disposable Blood Fluid Warming Sets are available in Standard Standard with Extensions Pediatric and High Flow models Disposable Flexible Warming Cassette Slot D Bubble Trap Holder Detachable Power Cord 2 1 Warmer see figure 1 The Medi Temp II FW400 Series Blood Fluid Warmer is a sealed fluid resistant device A lighted on off circuit breaker is located on the side panel An LED temperature display is located on the front panel Fluid temperature is indicated in degrees Celsius on the display Also located on the front of the unit is a slot for insertion of the Blood Fluid Warming Set s flexible cassette On the side of the unit is a holder for the bubble trap The Blood Fluid Warmer can be placed in an X Ray cassette slot within an operating room table or on horizontal surfaces An integral pole clamp also allows the unit to be pole mounted Lighted On Off Circuit Breaker Test Switch Access Screw Refer to Gaymar Medi Temp II FW400 Series Blood Fluid Warmer Service Manual Figure 1 Medi Temp II FW400 Series Blood Fluid Warmer Operator s Manual FW400 Series Blood Fluid Warmer 2 2 D
13. nal surfaces of the Warmer use a months oras per hospital protocol by qualified medical We cigani luti h as warm water service personnel in accordance with the Medi Temp ll lee Bee ged eege ee FW400 Series Blood Fluid Warmer Service Manual contact your local dealer or Gaymar to obtain the Service Manual To clean the inside of the Warmer flush the cassette slot with cleaning solution over a sink The slot is open at the 6 0 Technical Specifications Voltage 120V 100V 220 V 240V Capacity 1200 W Frequency 50 60 Hz 50 Hz Ambient Temperature 15 6 C 29 4 C 60 F 85 F Detachable 15 feet long Use only UL listed type SJT Detachable 4 6 meters 16 AWG 3 conductor cord with molded on grounding long Use only an type hospital grade attachment plug international harmonized 3 wire cord using cordage approved to HD 21 conductor size 1 00 mm2 HOSVVF3G1 00 Classification Class 1 grounded splash proof equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide IPX4 Weight 4 5 kg 10 pounds Size 35 mm x 235 mm x 275 mm 1 3 8 x 9 1 4 x 10 3 4 Power Cord
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