INFU Box - Defence Industries
Contents
1. Description Article no Electronics unit 299 000122 PCB Infusion heat controller 382 000250 Voltage Guard 382 000252 Heat sensor 382 000251 Heat cool unit 299 000120 28 299 000122 ELECTRONICS UNIT 382 000252 382 000250 INFUSION HEAT VOLTAGE GUARD CONT ROLLER MAIN SWITCH 382 000251 OVERTEMP SWITCH HEAT SENSOR Opens at 100 C 299 000120 HEAT COOL UNIT 12 DC INPUT POWER Figur TI 1 Overview of the electronics system MAIN FUSE 29 The main mechanical function of the heating cooling system is shown in Figure TI 2 The peltier elements are controlled by the electronics to produce a temperature difference between the inner and external airflow During heating of the inner compartment the hot sides of the peltier elements are facing the heat flanges of the inner airflow During a cooling process the voltage potential is reversed over the peltier element thus cooling the side in contact with the inner air heat flanges e 3 i r External upper airflow Ll GC Internal lower airflow Figure TI 2 Airflow in INFU Box The main system is powered by a 12 V DC source The Fan outside drives the external airflow in the upper part of the INFU Box and the Fan inside drives the internal airflow The Infusion heat controller regulates the power through the peltier elements and also controls the LCD display and information feedback2. INFU Box Type 0412A Temperature regulation box for IV liquids Mounting Manual NOTE mounting is only to be made by personnel authorized by the manufacturer which also have authorization to perform electrical installations in ambulance vehicles 36 1 Checking the INFU Box After the INFU Box is unpacked control the unit for any visual damage If any visual damage is recognized please notify your local supplier immediately 2 Door hinge position The door hinge position is left handed as viewed towards the front panel if not agreed otherwise according to the purchase order If the door hinge position needs to be changed from left to right or vice versa this should be done by designated service personnel The following procedure describes the change of door position 1 If mounted in a vehicle remove the INFU Box out the wall frame and disconnect the power cord 2 Unscrew the four screws that hold the Quick Guide plate on the inside of the door turn the plate upside down and re mount it using the same screws 3 At the bottom of the INFU Box below the hinge axis locate the steel rod and unscrew the rod using a screwdriver see Figure MM 1 A Figure MM 1 Unscrew the steel rod axis the picture shows a right hand side hinge location 37 4 Pull the steel rod completely out of the INFU Box see Figure MM 2 The door is now released from its former hinge axis wm Figure MM 2 Removal of door hi
3. Target temperature and high temperature alarm can be manually regulated Recommendations for target temperature because of intended use are body temperature Alarm temperature is set to warn before temperature is dangerously high Size Height about 545 mm Width about 500 mm Depth about 175 mm Weight 9 kg for INFU Box only and 11 kg for INFU Box with packaging Drive 12V DC max 180W Figure 12 1 INFU Box 26 Appendix Technical information and properties of INFU Box 1 Overview An overview of the INFU Box is shown in Figure TI 1 Front cover for electronics Front folio Label 12 V DC Label tech data Label MRE shelf section Figure TI 1 Overview of INFU Box and its components 27 2 Main components The main components of the INFU Box type 0412 are listed in Table TI 1 The main system function is shown in 299 000122 ELECTRONICS UNIT 382 000252 382 000250 INFUSION HEAT VOLTAGE GUARD CONTROLLER MAIN SWITCH AR 382 000251 FUSE OVERTEMP SWITCH HEAT SENSOR Opens at 100 C 299 000120 HEAT COOL UNIT 12 DC INPUT POWER Figur TI 1 Circuit diagrams are available from the manufacturer only on demand and only if necessary for performing the service as intended in the service manual only Table TI 1 Main components of INFU Box
4. the main fuse is ok If normal heating times also have been reported the voltage guards are also OK Otherwise see 4 Trouble shooting d Front panel Check that the foil of the front panel is intact Try pressing each regulation button and check that they are working intact Check that the diodes no 1 no 2 and power button are working Check that all elements of the display are intact that every letter number can be read Check that INFU Box is robustly mounted in vehicle may have to be improved because of transport induced mechanical stress e ww f Check that shelves inside INFU Box door and other loose parts are robustly mounted g Check that the alarm function works set a low target temperature to save time and then set an even lower alarm temperature After some time the alarm function should give an audible alarm and indication on diode no 2 h Check that reached target temperature is indicated by diode no 1 set a low target temperature to save time i Confirm that the display temperature of the INFU Box roughly correspond to the expected temperature of the liquid bags For example this can be made by placing new bags in the INFU Box and after some minute compare the displayed temperature with what could be expected from the non heated bags 46 j Remember to re set target temperature and high temperature value to desired values after maintenance procedure NOTE 10 years after the
5. Handling of TY Guid Da es 5 eene 11 3 5 1 Restrictions for IV liquid vessel and volume 11 3 5 2 Restrictions for kind of IV Woud ee esceeeseecesseeeesneeeeeeeeeeseeeeeteeeeeaeees 11 3 5 3 Restrictions for procedure handling of IV liquid bags eeeeeeeeeeee 11 3 6 NIE 11 Environmental ere egene EE Sne 12 4 1 HEH 12 4 2 Storage EE 12 Electrical ratings sneren eege 13 5 1 e a ERE ETSA A 13 5 2 geg teste EE Ee 13 5 3 Emission and immunity 255 ceisigsnees ciesccetende Gesaeridede ns meecars rises oeeses lea nase 13 WISE PROCECUPE EE 15 6 1 The product and interface ege teste Eed eet 15 6 2 ONT CK SUI A ad wes tctoostannga soneutun sone conaegne son T AE 15 6 3 Mi manual snes aaen a E E R ENEE EE 15 6 4 Control paneleran a aae a a a eE EEEE En a eTa A 16 6 4 1 TOAL BAALE REESE EEEE T EE ie RS Eee 16 6 4 2 Display EE 16 6 4 3 Re 17 6 4 4 Control kuttong sean e dE Deg ee DEE EEN 17 6 5 Errors atid Warni Ss coves cc asatikeiiekt cede ane eile aa ae 17 6 5 1 High temperature Eeer Bee 17 6 5 2 Sensor error alarm seen e leed ase Vener edd See ed 18 6 6 Temperature regulation with INFU Box sessssesssesssesesssesseressersseressresseesseessee 19 6 6 1 SEINES oee ar e a e a ea aA A O a SeA EE E a T 20 Troubl SKOON TA iii ai E E E TE E EE PERE E 21 7 1 Alarm and rror E 21 7 2 Display turns blanks turns eegene e 21 7 3 INFU Box does mot stat 21 7 4 Slow temperature regulating process eege errereen ect ee gegen eege 22 8 Mai
6. Type 0412A Temperature regulation box for IV liquids Service Manual Recycling instructions Cleaning and contamination 42 1 Requirements and Information 1 1 Requirements Service on this device is only to be performed by service personnel authorized by the manufacturer Furthermore these personnel must be authorized to perform electrical installations in the intended ambulance vehicles 1 2 Information The position of the door can be changed left or right hinge location The following procedure describes the change of door position 1 If mounted in a vehicle remove the INFU Box out the wall frame and disconnect the power cord 2 Unscrew the four screws that hold the Quick Guide plate on the inside of the door turn the plate upside down and re mount it using the same screws 3 At the bottom of the INFU Box below the hinge axis locate the steel rod and unscrew the rod using a screwdriver see Figure SM 1 D Figure SM 1 Unscrew the steel rod axis the picture shows a right hand side hinge location 4 Pull the steel rod completely out of the INFU Box see Figure SM 2 The door is now released from its former hinge axis 43 Figure SM 2 Removal of door hinge axis 5 Move the door to the other side Mount the steel rod axis again and finally tighten the fixation using the screw driver Make sure the door moves freely 6 Ifthe INFU Box unit was taken out of a wall mounted location connect t
7. until measured INFU Box temperature has gone below the set alarm temperature x _ asi X Trt Figure 6 5 Press one of the buttons 1 4 to quiet the audible alarm 18 6 5 2 Sensor error alarm If the INFU Box display shows SENSOR ERROR this is an indication of that something has gone wrong with the sensor regulation After displayed message all temperature regulation will stop In order to re set the functioning switch off the INFU Box wait 10 seconds and then turn it on again If the SENSOR ERROR message still is shown again change to another INFU Box and contact the manufacturer 19 6 6 Temperature regulation with INFU Box 1 In climate controlled area 2 Set check target amp alarm temperature Turn INFU Box on with the power button according to instructions in Mini manual and or 6 6 1 Settings in User manual L KEE Recommended temperatures Target temperature 38 C 100 4 F Alarm temperature 42 C 107 6 F 3 Insert 3 IV bags in INFU Box 4 Close door amp wait for target temperature to be reached gt AIl h th le shelf Mavs SIAE Wine ide Sie This is indicated by the orange diode next to the display diode 5 Bring out IV bag with reached target 6 Verify that temperature is ok by temperature holding IV bag with bare hands Always double check the display temperature Always leave middle bag to last IV bag is now ready to be used in inf
8. C 60601 Compliance Electromagnetic environment test level level guidance The INFU Box Type 0412A is Electrostatic 6 kV contact 6 kV contact intended to be mounted in a discharge ESD ground based field operating 8 kV air 8 kV air vehicle such as ambulance or IEC 61000 4 2 military vehicle compliant with the requirements of SS EN 1789_2007 32 Electrical fast 2 kV for power 2 kV for power The INFU Box Type 0412A is intended to be mounted in a transient burst supply lines supply lines ground based field operating vehicle such as ambulance or IEC 61000 4 4 1 kV for Not Applicable military vehicle Hence the mains input output power quality should be that of lines such a vehicle Surge 1 kV line s to Not Applicable The INFU box is DC powered line s IEC 61000 4 5 2 kV line s to earth Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5s Not Applicable The INFU box is DC powered Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m The INFU Box Type 0412A is intended to be mounted in a ground based field operating vehicle such as ambulance or military vehicle Hence the power frequency magnetic fiel
9. MS that are not LIFE SUPPORTING The INFU Box Type 0412A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the INFU Box Type 0412A can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the INFU Box Type 0412A as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 0 35 P d 0 175VP d 0 35 P 0 01 0 035m 0 018m 0 035m 0 1 0 11m 0 055m 0 11m 1 0 35m 0 18m 0 35m 10 1 1m 0 55m 1 11m 100 3 50m 1 8m 3 50m For transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 35 Appendix Il Mounting Manual INFU Box
10. SV ONIOIDH el OR INFU Box Type 0412A Temperature regulation box for IV liquids User Manual including Service manual Mounting manual A A Rx only INFU Box is manufactured by Medical Rescue Equipment MRE Holding AS INFU Box bears the C marking and complies with the provisions of the Medical Device Directive 93 42 EEC and harmonized standards of the directive The Device is also compliant with the Swedish LVFS 2003 11 the Norweigan FOR 2005 12 15 nr 1690 and SS EN 1789 2007 Medical vehicles and their equipment Road ambulances Additionally the device complies with all applicable parts of the standards listed in Appendix II Applicable standards This manual reflects INFU Box type 0412A Revision 1 14 MRE Holding AS Contents 1 2 3 ETE TA ee en e ee Ee 6 1 1 Medical device classfcapon 6 1 2 Electrical safety Classification scscecctsicessiscgyssacssuedevataudeduhvscnicigen totewes EE 6 1 3 Label with technical information cccccccccceessssssccecccceeeessssseeeeecceseseestsaeees 6 1 4 Intension OF 6 V1Ce tege geed egen 7 Meaning of symbols deele ed ee 8 Instructions before W864 Agegg e ger geed ENEE deed 9 3 1 IN EES ANN Wy ATMEL 5 ee 9 3 2 VE Ee le EE 10 3 3 Restrictions regarding temperature eeceesceceeseeceeneeeeeeeeeeeeeeeeeeeeeseeeeeeeeees 10 3 4 Temper t r EE 10 3 5
11. atmospheric pressure on ground anywhere on earth 4 2 Storage transport When the INFU Box is not mounted in the vehicle during storing or transport the original packaging shall be used The manufacturer only takes responsibility for the function of the device when stored transported in its original packaging in situations which fulfil the conditions of Table 4 II Table 4 II Environmental requirements for storage and transport Ambient temperature 45 C 70 C 49 F 158 F Relative humidity No specifications Atmospheric pressure Normal atmospheric pressure on ground anywhere on earth If transporting with flight it is recommended to use a pressurized cabin 12 5 Electrical ratings The INFU Box is intended to be used with 12 V DC direct current Max current 16A The maximum effect of the device is 180 W 5 1 Voltage guard INFU Box has a built in voltage guard to prevent the device from emptying the vehicle battery for further information see appended Service manual If power supply goes below 11 V two out of three peltier elements cut out The power consumption is reduced to 30 The IV liquid is kept at temperature but warming process is slowed down When power supply again exceeds 12 5 V all elements are re activated If power goes lower than 6 V INFU Box will turn itself off until enough power is supplied again 5 2 Fuses Further information about fuses is found
12. declaration Electromagnetic emissions Table TI 2 Guidance Electromagnetic emissions Guidance and Manufacturers declaration Electromagnetic emissions The INFU Box Type 0412A is intended for use in the electromagnetic environment specified below The customer or the user of the INFU Box should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The INFU Box Type 0412A uses RF energy RF emissions only for its internal function Therefore its Group 1 RF emissions are very low and are not CISPR 11 likely to cause any interference in nearby electronic equipment The INFU Box Type 0412A is suitable for RF emissions use in all establishments other than Class B domestic and those directly connected to CISPR 11 the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Not Applicable IEC 61000 3 2 Voltage fluctuations flicker emissions Not Applicable IEC 61000 3 3 3 2 Guidance and Manufacturers declaration Electromagnetic immunity Table TI 3 Guidance Electromagnetic immunity Guidance and Manufacturers declaration Electromagnetic immunity The INFU Box Type 0412A is intended for use in the electromagnetic environment specified below The customer or the user of the INFU Box Type 0412A should assure that it is used in such an environment Immunity test IE
13. ds should be at levels characteristic of such a vehicle NOTE Uzis the a c mains voltage prior to application of the test level 33 3 3 Guidance and Manufacturers declaration Electromagnetic immunity Table TI 4 Guidance Electromagnetic immunity Guidance and Manufacturers declaration Electromagnetic immunity The INFU Box Type 0412A is intended for use in the electromagnetic environment specified below The customer or the user of the INFU Box Type 0412A should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the INFU Box Type 0412A including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms 10 Vrms IEC 61000 4 6 150 kHz to 80 d 0 35VP MHz d 0175VP 80 MHz to 800 MHz Radiated RF 3 V m 20 V m _ electromagnetic 80 MHz to 2 5 According to d 0 35 P 800 MHz 1o 2 5 GHz fields GHz requirements of IEC 61000 4 3 SS EN 1789_2007 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be les
14. e may have blown For each of the three heating elements there is a fuse If a fuse blows the corresponding element will stop the heating process Only contact service personnel authorized by the manufacturer for changing a blown fuse If the cooling regulation process is slow make sure that the environmental temperature is low enough to cool down the interior temperature The INFU Box is designed to use the environmental air for cooling and thus the compartment inside the vehicle should be close to normal room temperature 8 Maintenance cleaning and contamination 8 1 Maintenance For INFU Box to function fully the maintenance procedure included in the appended service manual should be performed at least once a year Daily confirm the regulation temperature of bags that are stored inside INFU Box maintained at body temperature by temporarily holding bags in hands The bags should feel warm but not uncomfortable in temperature Weekly check IV Liquid fluids so that solution clarity is normal that and expiration date has not been exceeded Yearly or at the designated service intervals maintenance routines described in the appended service manual will be performed by service personnel authorized by the manufacturer 10 years after the latest programming of the INFU Box processor the manufacturer should be contacted for a product update 23 8 2 Cleaning device clean the INFU Box with disinfectant detergent according to inst
15. essereseressressreeseeesseresseesseesse 41 1 1 edere WEE 41 dek MARL RYAN ANCA i ofa A A E Ee EN 41 1 3 Voltage guard voltage watch NEE 43 2 Change gn EE 43 3 Maintenance cleaning and contamnaton cece eeeeeeseeeseeeeeeeseeeeeeeseeeeaeees 44 3 1 Maintenance seision eerst 44 3 2 Clanin OG e o e a a oa aa a ear eae eera aaan aae 45 3 3 EH een 45 A Trouble Shooting earen oiio tee EEN Gi en ene 46 4 1 Alarm and error INC SS AS Coo ee EN 46 4 2 Display turns blank turns off EE 46 4 3 INEU Box does tat eieiei eege 47 4 4 Slow temperature regulating process ssesesssseseseeesseressressetsseressetsseresseesseresee 47 5 Recycling instructions siseses e ar rE EEE ERE EE RE ESS 47 G Se rviceand Spare Parts rnern e a A E TE E EEAS 47 6 1 Cable C ta irion nran en e atts oe EE EREE E REEE abot item 47 7 Contact information to Manufacturer ecceeeecceesceceeseeeeeseeceeneeeeeneeeeeeeeeeaeeees 50 1 General Please read this manual thoroughly before starting to use this equipment Federal law restricts this device to sale by or on the order of a physician 1 1 Medical device classification Table 1 Medical device classification Classification EU CE mark Class I USA FDA Class II 1 2 Electrical safety classification According to IEC 60601 1 Electrical safety INFU Box is classified as shown in Table 2 Table 2 Electrical safety classification Classification Protection against electr
16. ging the main fuse or resetting the thermo switch can cause more damage to the INFU box Call for proper service or contact the manufacturer 4 4 Slow temperature regulating process If the process to reach the target temperature is slower than normal the power supply is less than 11V or a fuse for one or more of the heating cooling elements are blown The INFU box is still operational but change the unit at first possibility Do not attempt to change the fuses as the heating element can be destroyed If the cooling regulation process is slow make sure that the environmental temperature is low enough to cool down the interior temperature The INFU Box is designed to use the environmental air for cooling and thus the compartment inside the vehicle should be close to normal room temperature 5 Recycling instructions When disposed INFU Box shall be de mounted and distributed to appropriate waste management All polymeric materials shall be wasted according to national recommendations All electronic parts shall be de mounted and returned to national authorities responsible for electronic waste Other parts shall be recycled according to national recommendations All packaging material shall be wasted according to national recommendations All materials can be sent to manufacturer for recycling see contact information below 6 Service and Spare parts 6 1 Cable cord The INFU box shall be connected to a 12V battery using the po
17. he power cord again and mount the unit back at its location 44 1 3 Voltage guard voltage watch In order not to discharge the battery of a non running ambulance vehicle the INFU Box is equipped with a voltage guard The unit is designed to work at a nominal voltage of 12 V DC If the voltage source drops below 11 V the power consumption goes down The INFU Box controls this by cutting out 2 of 3 peltier elements All peltier elements will again be activated if the source voltage reaches higher than 12 5 V or if the INFU Box is shut off and then restarted while connected to an accurate 12 V DC source If the voltage source should go even further down below 6 V the INFU Box shuts down completely 2 Change of fuses Fuses shall not be changed unless there is a full service test facility available Table SM 1 Fuses of the INFU Box Number Main Fuse F1 FST6 3X32 20 A 1 Fuses Voltage Guard Circuit Board F1 T1A 250V 1 A No 372K TRS 1 F2 F4 T5A 250V 5 A No 372K TR5 4 45 3 Maintenance cleaning and contamination 3 1 Maintenance For INFU Box to function fully the following procedure should be performed at least once a year a Cleaning Clean INFU Box according to the description in the next section b Ocular inspection Do an ocular check of INFU Box and see that no rust or unsmooth surfaces are discovered c Check fuses Turn INFU Box on If display and diodes are working
18. ical shock Class I Protection against harmful ingress of water P20 The device has class 2 protection against solid foreign objects and class 0 for water tightness The device is protected against solid objects with a diameter of 12 5 Ceo mm and a pressure of 30 N 10 and has no protection against water 1 3 Label with technical information On the inside of INFU Box door a label is placed with technical information of the device see Figure 1 1 Wa Type INFU Box 0412A 12V 180W Manufactured by Medical Rescue Equipment AS Postboks 186 3901 Porsgrunn Norway Phone 47 90610425 Fax 47 35515014 SR IP20 E mail Info mre holding com Ba Rx only Homepage www mre holding com EEHEHE CAL pennos ____ CE Figure 1 1 Label with technical information for INFU Box 1 4 Intension of device The INFU Box is intended for the regulation of temperature of intravenous fluids bags prior to administration The device is intended for bags with crystalloid fluids only Intended users are health care professionals The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle such as ambulance or military vehicle 2 Meaning of symbols Existing symbols on the INFU Box unit are shown in Table 3 Table 3 symbols on the INFU Box Symbol Meaning CE mark Indicates that the product complies with the Medica
19. ill only stabilize around the set target temperature See further information is 3 3 Restrictions regarding temperature gt Warning Too high target temperatures might be dangerous to the patient See further information in 3 3 Restrictions regarding temperature gt Warning Whenever using a pre tempered IV liquid bag from INFU Box verify suitable temperature by holding bag with bare hands and estimate the bag temperature gt Warning The internal temperature indicated on the INFU Box display may differ some degrees from the actual temperatures in the infusion bags See further information in 3 4 Temperature deviations gt Warning INFU Box may not be used more than 10 years after last programming date Contact manufacturer for a new product update See further information in 8 1 Maintenance and the appended Service Manual gt Note There might appear warnings messages on the INFU Box display A description of these can be found in 6 5 Errors and warnings gt Note INFU Box is only to be used together with a functioning climate system in the ambulance See description in 6 6 A Note INFU Box is intended to perform temperature control on 3 IV bags simultaneously all bags having the same original temperature In order to achieve accurate temperature control always make sure that the middle shelf carries an IV bag Make sure the INFU Box is fully emptied before new IV bags are
20. in the appended Service manual Note Not to be changed in field 5 3 Emission and immunity The electromagnetic compatibility of the INFU Box has been tested and approved according to the standard IEC 60601 1 2 2007 13 Table 5 I Performed EMC tests Emission Conducted emission Radiated emission Interference immunity Electrostatic discharge Electromagnetic field Electrical Fast Transient Burst Conducted disturbances induced by RF fields Magnetic field power frequency A summary of the results of the tests in 14 Table 5 I and related recommendations is included in 3INFU Box properties For special precautions regarding EMC the INFU Box shall be installed and put into service according to the EMC information provided in Appendix I Technical information and properties of the INFU Box Portable and mobile RF communications equipment can effect medical electrical equipment such as the INFU Box 15 6 Use Procedure 6 1 The product and interface The product is intended to regulate the temperature of IV liquid bags prior to infusion The box is electronically regulated to obtain and maintain a preset temperature Control panel Mini manual Quick Pe EE 7 A guide Compartment for maximum 3 IV liquid bags of 1000 ml infusion each Figure 6 1 INFU Box 6 2 Quick guide There is a Quick guide that describes how to use INFU Box The Quick guide is fo
21. indication that internal temperature reaches the pre set alarm temperature This is indicated by a display message a diode light and an audible beep signal See 6 5 Errors and warnings 7 2 Display turns blank turns off If the supplied voltage source goes lower than 6 V the INFU Box will turn itself off until enough voltage is supplied again over 6 V If the display is blank it can also be a sign that the main fuse is broken Service personnel is then required 7 3 INFU Box does not start If INFU Box does not start at all e Check that contacts and cables are connected and that power is supplied from external source e Ifthe INFU Box has been exposed to extreme temperatures leave the unit in room temperature for 10 minutes and then try to start it again e If none of above mentioned steps works service personnel authorized by the manufacturer should be contacted 22 7 4 Slow temperature regulating process There are three heating elements in the INFU Box for temperature regulation To prevent the vehicle battery from emptying the INFU Box has a built in voltage guard If power supply goes below 11 V two out of three heating elements cut out IV liquid is kept in temperature but warming process is slowed down When the voltage supply becomes 12 5 V or higher all elements are again activated If the process to reach target temperature is slower than normal the power supply can have dropped below 11 V or a peltier element fus
22. ions When disposed INFU Box shall be de mounted and distributed to appropriate waste management All polymeric materials shall be wasted according to national recommendations Al electronic parts shall be de mounted and returned to national authorities responsible for electronic waste Other parts shall be recycled according to national recommendations All packaging material shall be wasted according to national recommendations All materials can be sent to manufacturer for recycling see contact information below 11 Manufacturers contact information MRE Medical Rescue Equipment Holding AS Postboks 186 3901 Porsgrunn Norway Phone 47 90610425 a Fax 47 35515014 Gaza E mail info mre holding com Homepage www mre holding com 25 SV ONIOIDH 12 Product data sheet Company name Medical Rescue Equipment MRE Holding AS Product name INFU Box Model designation 0412A Military IN warmer A first release version Description INFU Box is a temperature regulation box for bags with infusion liquid The device is intended to be used mainly in acute medicine and military fields The box is intended to be mounted in a vehicle for example ambulance or military vehicle The device is electrically regulated and intended to obtain and maintain correct temperature body temperature for bags with IV liquid before infusion The box has room for three IV bags of 1000 ml liquid each
23. ise with INFU Box described In case of further problems please contact manufacturer 4 1 Alarm and error message In normal use the only alarm message on the device is indication that internal temperature reaches the pre set alarm temperature This is indicated by a display message ALARM a diode light and an audible beep signal If the INFU Box display shows SENSOR ERROR this is an indication of that something has gone wrong with the sensor regulation After displayed message all temperature regulation will stop In order to re set the functioning switch off the INFU Box wait 10 seconds and then turn it on again If the SENSOR ERROR message still is shown again contact the manufacturer 4 2 Display turns blank turns off If the supplied voltage source goes lower than 6 V the INFU Box will turn itself off until enough voltage is supplied again over 6 V If the display is blank it can also be a sign that the main fuse is broken chapter 4 3 below 48 4 3 INFU Box does not start If the INFU box does not start at all Check the power cable and that the 12V DC is present If power is ok the problems can be one of the following 1 Main fuse blown probably caused by an internal short circuit 2 The 100 dgr thermo switch is released due to high temperature on the heat sink Probable caused by stopped fan s or faulty electronics Any of these causes are reason to have a complete check out of the equipment Chan
24. l CC Device Directive 93 42 EEC General warning sign Warning Caution or Note This symbol indicates need for extra observance Consult user manual for further information A A BE Consult instructions for use IPN N IP class N indicates the dust sand tightness protection against ingression of dust sand of the device N2 indicates the ability of the device to withstand intrusion of water protection against the ingression of water Serial number A unique number for every manufactured INFU Box unit Number can be used for traceability Manufacturing date Indicates the date of manufacture for the unit sei ON power OFF power Direct current al WEEE symbol Indicates that the product complies with the WEEE directive 2002 96 EG waste electrical and electronic equipment Rx only Federal law restricts this device to sale by or on the order of a physician 3 Instructions before use The device is only intended to be operated by personnel with medical education that have read the User Manual Service and mounting installation for device is only to be performed by qualified service personnel according to descriptions in the appended service and mounting manual 3 1 Notes and warnings gt Warning Avoid setting the target temperature to other than approximately the normal body temperature The interior temperature w
25. latest programming of the INFU Box processor the manufacturer should be contacted for a product update 3 2 Cleaning e When cleaning the INFU Box on the door and front use a moist cloth and any typical nonabrasive cleaning detergents available for households If contaminated use a disinfectant cleaning detergent such as DAX Ytdesinfektion Plus Alcohol 45vol or Gigasept Instru AF 3 solution Apply according to detergent product specification e Do not soak the unit Be especially careful around air inlets see Figure SM 3 No liquid whatsoever is allowed to penetrate into the unit e For cleaning the interior compartment of the device use the same procedure as on outside At the bottom of INFU Box a small brush is required for example a toothbrush to be able to clean below bottom shelf e If IV bag has leaked thorough cleaning may be required due rests from NaCl solutions 3 3 Contamination If there is danger of contamination of the device clean INFU Box with disinfectant detergent according to instructions above 47 Air in and outlet P 24 AEE ee GEET EE Figure SM 3 Air inlet and outlet of INFU Box 4 Trouble Shooting Below are a number of problems that may ar
26. nge axis 5 Move the door to the other side Mount the steel rod axis again and finally tighten the fixation using the screw driver Make sure the door moves freely 6 Ifthe INFU Box unit was taken out of a wall mounted location connect the power cord again and mount the unit back at its location see Section 3 and 4 38 3 INFU Box location in ambulance vehicle When the location for installation of the INFU Box is determined please note the following requirements prior to installation 1 Free depth behind the inner wall to be at minimum 170 mm 7 inch 2 Ensure that the door may be opened without interfering with existing equipment or equipment to be installed 4 Installation of INFU Box in ambulance vehicle 1 Mark the opening area to be removed according to the following dimensions see Figure MM 3 Opening height 497 mm Opening width 452 mm Width 452 mm Height 497 mm T z Figure MM 3 Opening dimensions of wall opening 2 Cut the area to be removed with an electrical saw or similar 3 Place the INFU Box into the opening and make sure the dimensions are correct 4 Mark the holes for screws in the wall using the premade holes in the INFU Box frame as a template Remove the INFU Box and drill 3 mm holes through the 39 marks on the wall These holes will now act as positioning holes for the screws 5 Connect the INFU Box power supply according to the following sections 5 Electrical power suppl
27. ngs EE HOHE Hi EE Er Figure 6 3 Example of display with temperature in Celsius 17 TES fe Figure 6 4 Example of display with temperature in Fahrenheit 6 4 3 Diodes Diode 1 Indicator for reached target temperature is lit with an orange light when INFU Box reaches target temperature corresponding to the surface temperature on IV bag on middle shelf Diode 2 Warning for reached alarm temperature is lit with an orange light when the set alarm temperature is exceeded There will also be an audible alarm For further information see 6 5 Errors and warnings 6 4 4 Control buttons The control buttons under the display are used to set the target and alarm temperatures for changing between temperature units and for shutting down the audible feedback when the alarm temperature is reached however Control button 2 has no operator function When setting the temperature the device gives audible feed back in form of beep signals For further information about the settings see 6 6 1 Settings 6 5 Errors and warnings 6 5 1 High temperature alarm If INFU Box exceeds the set alarm temperature diode 2 is lit and an audible alarm is heard The display also shows a warning message ALARM and shows the set alarm temperature The audible alarm can be silenced by pushing one of the control buttons 1 4 under the display see Figure 6 5 Diode 2 maintains lit and the error message on the display remains
28. ntenance cleaning and contamnaton 22 8 1 Eupen 22 8 2 E EE 23 8 3 Re E NON EE 23 9 Seryice and enn 23 TO Recycling Instructions sns Sue 24 11 Manufacturers contact pformatton 24 12 Prod ctdata Sheet EE 25 Appendix I Technical information and properties of INFU Box 26 Je a eet 26 2 gt EIERE gedet eege eg EE tes taka 27 erer 29 3 ENO BOK Propere Sea cca thas ps e A a Ee a E EOE E TESE EIES 30 3 1 Guidance and Manufacturers declaration Electromagnetic emissions 30 3 2 Guidance and Manufacturers declaration Electromagnetic immunity Error Bookmark not defined 3 3 Guidance and Manufacturers declaration Electromagnetic immunity Error Bookmark not defined 3 4 Guidance and Manufacturers declaration Electromagnetic immunity Error Bookmark not defined Appendix II Mounting Manual INFU BOX cece eeeeeeeseeceseeeeeseeceeeeeeeeneeceeaeeeeeaeeees 34 k Checking the INFU Box Attest EE EEN 35 2 DOOR MMS ENEE Ee E Eege ug 35 3 INFU Box location in ambulance vehicle eeeeceeeseeceeseeeeeeeeeeeneeeeeaeeeeeaeeees 37 4 Installation of INFU Box in ambulance Vehicle 0 eee eeeceeeeseeeeeeeeeeeneeeeeneeees 37 5 Electrical power supply and connection ccsecccessresereresenetessnenerenensesscsones 38 Appendix II Service Manual INFU BOX sesseessesseseesereressersessresressrssresrersessresereseesrese 40 1 Requirements and Information ssssseseseeeeseeesseesseessee
29. of IV liquid bags Whenever there are bags kept in INFU Box make sure a bag is placed on the middle shelf where the temperature sensor is located INFU Box has to be emptied before new bags are mounted All IN bags mounted have to have the same original temperature Do not use IV liquid that is blurry or non transparent Only use new sealed IN liquid bags nor earlier used on patients Beside these restrictions follow the standard handling procedure of IV liquid bags 3 6 Noise level The INFU box noise level at 1 0 meter distance is 50 55 dB 11 4 Environmental requirements 4 1 Operating The device is designed to be operated in a room tempered environment The device uses environmental air to cool down the IV liquid If during a cooling process the difference between target temperature and environmental temperature becomes too small the cooling process of the INFU Box will be insufficient and the target temperature not reached The manufacturer only takes responsibility for the function of the device when used in situations which fulfil the conditions of Table 4 I Table 4 I Environmental requirements for operation Ambient temperature 15 30 C 59 86 F In order to work satisfyingly INFU Box is not to be used without a climate system controlled environment Relative humidity Room temperature 20 2 C 30 75 in combination with temperature RH 64 72 F 30 75 RH Atmospheric pressure Normal
30. placed on the shelves See description in 3 5 3 3 2 Contraindications e Do not use device with infusion bags containing blood or other protein based liquids e Do not use device outside recommended temperature range e Do not use device in other environmental situations than those specified in 4 e Do not use device in other electrical setup than the one specified in 0 3 3 Restrictions regarding temperature The INFU Box is intended to regulate and maintain the temperature of IV liquid The operator does this by setting a target temperature on the INFU Box The device then adjusts the temperature inside the INFU Box compartment until the set target temperature is reached and maintains that temperature Recommended target temperature is normal body temperature Temperatures over body temperature endeavour the patient safety due to the risk of coagulation and thrombosis or hyperthermia Too cold temperatures endeavour the patient safety due to the risk of hypothermia To achieve a better control of unwanted temperature limits the operator can also set an alarm temperature If the interior temperature reaches the set alarm temperature the operator is given audible as well as visual feedback The intended use of the INFU Box is to set the target temperature close to normal body temperature and the alarm temperature to typically some degrees higher It is possible to set both the target temperature and the alarm temperature to othe
31. r temperatures but this is NOT RECOMMENDED The manufacturer takes no responsible for use outside recommendations 3 4 Temperature deviations During a heating process from room temperature when the device is equipped with 3 bags the INFU Box display value reaches body temperature after about hour if recommended power supply to the device is provided sufficiently The display temperature corresponds to the surface temperature of the IV bag in the middle shelf The core temperature of the bag can deviate from its surface temperature and the bag temperature may also deviate between the bags in different positions in INFU Box Longer time of temperature control inside the INFU Box gives less deviation between bags 10 During a cooling process the temperature change is not as fast as during warming As an example the cooling of 3 IV bags from 50 C 120 F down to normal body temperature typically takes 3 hours 3 5 Handling of IV liquid bags 3 5 1 Restrictions for IV liquid vessel and volume Intended IV liquid bags are soft plastic bags with 1000 ml IV liquid INFU Box is designed to regulate three liquid bags simultaneously 3 5 2 Restrictions for kind of IV liquid This device is intended for use with crystalloid fluids only such as normal saline and Ringer s lactate solutions Do not warm any proteins based fluids or nutrition in the device Do not use device to heat blood 3 5 3 Restrictions for procedure handling
32. ructions above INFU Box does not guarantee protection from blood infections When cleaning the INFU Box on the door and front use a moist cloth and any typical nonabrasive cleaning detergents available for households If contaminated use a disinfectant cleaning detergent such as DAX Ytdesinfektion Plus Alcohol 45vol or Gigasept Instru AF 3 solution Apply according to detergent product specification Do not soak the unit Be especially careful around air inlets see Figure 8 1 No liquid whatsoever is allowed to penetrate into the unit For cleaning the interior compartment of the device use the same procedure as on outside At the bottom of INFU Box a small brush is required for example a toothbrush to be able to clean below bottom shelf If IV bag has leaked thorough cleaning may be required due rests from NaCl solutions 8 3 Contamination In and out If there is danger of let contamination of the for air Figure 8 1 INFU Box 9 Service and Spare parts INFU Box cable cord is a spare part and can be exchanged by authorized service personnel The INFU Box door is reversible mounted on the left or the right side and changing the hinge location shall also be performed by authorized service personnel For further information se appended Service Manual or contact manufacturer Detailed service instructions are found in the attached Service manual 24 ge d 10 Recycling Instruct
33. s than the compliance level in each frequency range Interference may occur in the vicinity surroundings of equipment marked with the following symbol UG NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 34 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To asses the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the INFUBox Type 0412A is used exceeds the applicable RF compliance level above the INFUBox Type 0412A should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the INFUBox Type 0412A Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 3 4 Guidance and Manufacturers declaration Electromagnetic immunity Table TI 5 Guidance Electromagnetic immunity Recommended separation distances between portable and mobile RF communications equipment and the InfuBOX for ME EQUIPMENT and ME SYSTE
34. to the user The peltier element regulation is based on information from the Temperature sensor The Voltage guard controls how much power the INFU Box uses based on measuring the supply voltage level If the voltage gets lower for example from a weak vehicle battery the Voltage guard shuts down 2 out of 3 peltier element in order not to empty the battery The full capacity is restored when the supply voltage level returns to normal Performance heating process The figure below shows the time to heat three IV bags from room temperature of 24 to a body temperature of 38 C With an environmental temperature of 24 C the heating time is approximately 1 hour Following a 24 hour period of INFU Box storage in 45 C the heating time is approximately 2 hours and 15 minutes Note the warming should always be done in a room tempered environment for example in a climate controlled vehicle ine BK 3 20 40 60 80 100 120 140 160 Minutes to reach body temp infusion bags initially room tempered INFUBox environment temp CH Figure TI 3 Time for three Infusion bags to reach body temperature in INFU Box starting from room tempered state The upper bar shows the time when the INFU Box was stored in room temperature 24 hours before warming and the lower bar shows the warming time after 24 hours of storage in 45 C 3 INFU Box properties 3 1 Guidance and Manufacturers
35. und in a pocket inside INFU Box door see Figure 6 1 The Quick guide information is also available in 6 6 Temperature regulation with INFU Box and 6 6 1 Settings 6 3 Mini manual Inside the INFU Box door just below the front panel there is a Settings manual or Mini manual see Figure 6 1 The Mini manual briefly explains how to set the target temperature and the alarm temperature 16 6 4 Control panel The control panel see Figure 6 2 is the interface where the user can set target temperature alarm temperature and get feedback on the temperature control process Display Indicator for reached target temperature Power switch INFL BOX ree oz EH JME H D 3 D WARNING e a Control buttons Warning for reached alarm temperature Figure 6 2 Product interface 6 4 1 Power switch Above and below the power switch there are symbols to show if the INFU Box is turned on or off See below ON power OFF power 6 4 2 Display When the INFU Box is turned on the display shows a starting message consisting of the unit number The display shows the set target temperature to the left and the actual temperature to the right An arrow in the display indicates if the temperature is rising or sinking see Figure 6 3 and Figure 6 4 for example The temperature can be displayed in Celsius or in Fahrenheit For information on how to change between C and F see instructions in 6 6 1 Setti
36. usion treatment co a If INFU Box is left ON in a non running vehicle there is a risk of emptying the vehicle battery 20 6 6 1 Settings Below follows a description of how to regulate target temperature alarm temperature and changing between Celsius and Fahrenheit with the control buttons Setting target temperature 1 Press the 1 button 4 seconds for entering a 2 3 4 programming mode oa 3 Press the 3 button for adjusting temp down Sg 2 Press the 4 button for adjusting temp up aN 4 Press the 1 button for exit gee Setting the alarm temperature 1 Press the 1 and 4 button 4 seconds for entering programming mode C CW 3 Press the 3 button for adjusting temp down H WW 2 Press the 4 button for adjusting temp up aN 4 Press the 1 button to exit gee 21 Changing between C and F 1 Press the 1 3 and 4 2 Press the 4 button button and hold for switching 4seconds Gm between Dt to enter C and F programming 2 D 2 G mode E N ee 3 Or press the 3 4 Press the 1 button button for to exit between C C and F DLA a 7 Trouble Shooting Below are a number of problems that may arise with INFU Box described In case of further problems please contact manufacturer 7 1 Alarm and error message In normal use the only alarm message on the device is
37. wer supply cord If needed this power cord can be replaced by service personnel Only use original power cords from the manufacturer 49 When changing the power cord take the cabinet first out of the panel wall in the ambulance vehicle To dismount the old cord from the socket lift the metallic sleeve as shown in Figure SM 4 Remove the other end from the 12 V DC supply and connect the new cord to the same power source see Figure SM 5 connect the positive supply to the cable end marked and the negative supply to the cable end marked When mounting the new cord on to the INFU Box make sure the red marking is placed in line with the red marking of the socket see Figure SM 6 Figure SM 4 Lift the sleeve to dismount the cord from the socket Figure SM 5 The end of the power cable shall be mounted to the vehicle 12 V DC power supply 50 Figure SM 6 Place the red marking on the cord in line with the red marking on socket 51 7 Contact information to Manufacturer MR MRE Medical Rescue Equipment Holding AS Postboks 186 3901 Porsgrunn Norway SV SNIGIOH Phone 47 90610425 Fax 47 35515014 E mail info mre holding com Homepage www mre holding com 52
38. y and connection Power requirement The INFU Box is engineered for a power requirement supply of 12 V DC from the vehicle 20A fuse Max current 16A If any other voltage is to be connected it is mandatory to install a DC converter between the existing power source and the INFU Box 1 Mount the Power Connector cable at the top connector location Make sure the red dot of the connector orients towards the red dot at the insertion see Figure MM 4 Figure MM 4 Mounting the Power Connector to the INFU Box 2 Connect the 12 V DC positive power supply to the cable end marked and the negative to the cable end marked For max fuse see table below Table MM 1 Fuses of the INFU Box Number Main Fuse F1 FST6 3X32 20 A 1 Fuses Voltage Guard Circuit Board F1 T1A 250V 1 A No 372K TRS 1 F2 F4 T5A 250V 5 A No 372K TRS 4 40 3 4 For testing the unit please turn on the switch located at the upper right on the front panel The INFU Box display shows the start up message If the INFU Box does not start please check the power supply again If the INFU Box still not operates contact the manufacturer After positive function test mount the INFU Box back in the designated location in the panel Make sure that the power cable is not jammed or stressed Fixate the INFU Box to the panel using 8 screws of appropriate sizes 41 Appendix Ill Service Manual INFU Box INFU Box
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