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User Manual / Technical Manual

Version: INT/R683-EN-3-10-17

Summary of Contents for Fluido Compact

Page 1: ...User Manual Technical Manual Version INT R683 EN 3 10 17...

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Page 3: ...15 3 4 Overview of the disposable sets 15 3 4 1 Standard Set REF 672000 15 3 4 2 Standard Set with drip chamber REF 672100 16 3 5 Overview of the control panel 16 3 6 Indicator LED behaviour 17 3 6 1...

Page 4: ...7 2 2 Disconnect interface cable 33 7 2 3 Connect interface cable 33 7 2 4 Connect power supply cord 34 7 3 Fuse 34 7 3 1 Remove fuse holder 34 7 3 2 Remove fuse 34 7 3 3 Place fuse 35 7 3 4 Place fu...

Page 5: ...9 Specifications 43 9 1 Specifications of the device 43 9 2 Specifications of the disposable sets 44 10 Electromagnetic compatibility 46 10 1 Electromagnetic immunity 46 10 2 Electromagnetic emission...

Page 6: ...Fluido Compact Standard Set with drip chamber hereafter referred to as standard set with drip chamber The manual helps you with the operation and the maintenance of the device in a safe and responsib...

Page 7: ...mechanically in print photographic print on microfilm or by any other means whatsoever without the explicit consent of The 37Company The content of this document has been compiled with the greatest po...

Page 8: ...evice in any of the following cases Clean and dry the warming surface if the warming surface is wet e g leaked IV fluids blood cleaning agents the warming surface is dirty e g coagulated blood Use a n...

Page 9: ...gulations Take care that the device is not dropped to reduce the risk of damage When dis connecting the interface cable make sure the mains plug is disconnected from the electrical outlet 2 1 3 Notes...

Page 10: ...5 min According to IEC 60529 Pressure Do not use the device if the package is damaged Caution Federal US law restricts this device to sale by or on order of a physician As to electrical shock fire an...

Page 11: ...e Transport and storage relative humidity range Transport and storage atmospheric pressure range Keep away from sunlight Keep away from rain AC voltage Type BF applied parts according to IEC 60601 1 E...

Page 12: ...for use for important cautionary Standby on Upper limit temperature Check the device and the power cords for damage Do not use the device if it is damaged Do not use a damaged disposable set to preve...

Page 13: ...cator Modification update example MOD 6 Plug the device into an earthed mains socket Do not move the device on a pole during use Remove the device from the pole before you move it Class II equipment w...

Page 14: ...2 Warming module see Overview of the warming module REF 650200 on page 15 3 Disposable set see Overview of the disposable sets on page 15 3 2 Overview of the control module REF 650100 1 Control panel...

Page 15: ...of the warming module REF 650200 1 Slider 2 Warming interface 3 Status indicator LED 4 Interface cable 5 Cable clamp 3 4 Overview of the disposable sets 3 4 1 Standard Set REF 672000 1 Luer Lock male...

Page 16: ...mber 6 Cassette with Luer Lock female Standard Set with drip chamber 672100 is not available in the U S The drip chamber on the standard set with drip chamber is meant to be used as a deaeration chamb...

Page 17: ...ure at the outlet of the disposable cassette is out of set point range Repair required Yellow continuous An error is detected The device cannot be used When the system is warming an audible alarm repe...

Page 18: ...depends on the fluid flow rate and environmental conditions If the fluid inlet temperature and environmental temperature are 20 C the temperature at the end of the patient line is 39 2 C at flow rates...

Page 19: ...on page 25 Check if the warming surface of the warming module is wet or contaminated If wet or contaminated clean and dry the surface see Cleaning on page 30 Reset the device Disconnect the power sup...

Page 20: ...ications on page 43 4 2 Install the cables 4 2 1 Remove the hatch 1 Remove the bolt A from the hatch using a 2 mm hex key The used bolt is M3X8 A2 70 DIN7984 A 2 Remove the hatch B 4 2 2 Install the i...

Page 21: ...h upwards until it is closed 3 Fasten the bolt in the hatch 4 3 Change the rotation of the universal clamps optional Turn the universal clamp 90 if you want to install the universal clamp to a bed rai...

Page 22: ...ice make sure that the operator can read the control panel from his normal working position 1 Open the universal clamp A 2 Position the control module such that universal clamp encloses the IV pole B...

Page 23: ...rgency To remove all power disconnect the power supply cord Check the patient s condition and temperature at least every 15 minutes Do not maintain the device while it is in use with a patient Make su...

Page 24: ...the slider C of the warming module 5 Put the cassette of the disposable set D in the warming module The cassette fits in only one way 6 Close the slider The status indicator LED on the warming module...

Page 25: ...standard set Prime the hospital administration set and the standard set 1 Hold the standard set in the upright position Make sure that the slide clamp A of the standard set and the roller clamp B of...

Page 26: ...A of the disposable set is closed and the roller clamp B of the hospital administration set is open 2 Hold the drip chamber C upside down 3 Remove the cap D from the T connector E and connect to a syr...

Page 27: ...ut the warming module near the patient Warning Do not position the warming module close to the head of the patient if inhaler therapy is used Only use a syringe at an injection point A at the end of t...

Page 28: ...chnical Manual Operation 28 of 49 2 Close the roller clamp B of the hospital administration set 3 Close the slide clamp C of the patient line 4 Disconnect the patient line D from the IV catheter 5 Ope...

Page 29: ...e disposable set F from the warming module Warning If it is necessary clean the warming module according to hospital guidelines See Cleaning on page 30 7 Close the slider G 8 Put the warming module H...

Page 30: ...the device on page 40 The essential performance of the device is to warm fluids within the safe temperature and time limits according to ASTM F2172 2 Testing is required to validate if the device sti...

Page 31: ...use the device and replace the warming module 6 1 3 Cleaning of the control module Caution To clean the control module Use solutions with less than 2 4 glutaraldehyde Obey the manufacturer s recommend...

Page 32: ...d After repair always test the device according to Test the device on page 40 Caution Place the device on a soft and stable surface Wear latex gloves and static discharger when handling internal compo...

Page 33: ...le 1 Remove the hatch see Remove hatch on page 32 2 Turn the connector ring on the interface cable A to the open position 3 Disconnect the interface cable 7 2 3 Connect interface cable 1 Turn the conn...

Page 34: ...upply cord see Disconnect power supply cord on page 33 and interface cable see Disconnect interface cable on page 33 3 Push the locking pin inward and remove the fuse holder A 7 3 2 Remove fuse 1 Remo...

Page 35: ...Place fuse holder 1 Place the fuse holder A 2 Connect the interface cable see Connect interface cable on page 33 and power supply cord see Connect power supply cord on page 34 3 Place the hatch see P...

Page 36: ...r supply cord on page 34 4 Place the hatch see Place hatch on page 32 7 5 Front cover and control panel 7 5 1 Remove front cover and control panel 1 Remove the hatch see Remove hatch on page 32 2 Disc...

Page 37: ...s C using a Torx T9 key 7 Disconnect the user interface flat cable D from the controller board E 8 Remove the front cover with user interface F 7 5 2 Place front cover and control panel 1 Connect the...

Page 38: ...board F Do the same with the controller cable G 5 Carefully place the front cover on the back cover Caution Make sure no cables are clamped when the front cover is placed on the back cover 6 Align the...

Page 39: ...Technical Manual Repair 39 of 49 8 Connect the interface cable see Connect interface cable on page 33 and power supply cord see Connect power supply cord on page 34 9 Place the hatch see Place hatch...

Page 40: ...reparation 1 Connect a metal catheter to the end of the patient line 2 Open the clamps on the hospital administration set and the patient line 3 Make sure that the complete standard set and the cathet...

Page 41: ...e increase in volume millilitre IV fluid in the measuring cup over a period of time 4 Make sure that the IV fluid temperature at the end of the patient line 40 centimetre is between 37 41 C after temp...

Page 42: ...patient line 8 3 3 Procedure 1 Push the standby on button to put the device in on mode 2 Open the slider a few millimetres until the set point indicator LED is off 3 Flush the hot water into the stand...

Page 43: ...ngth power cable 400 cm Length interface cable 180 cm Weight control module 1700 g Weight warming module 450 g Class IEC 60529 control module IPX1 Class IEC 60529 warming module IPX4 Class IEC 60601 1...

Page 44: ...ming volume standard set with drip chamber 15 ml 16 ml with 300 mmHg pressure Patient line length standard set 40 cm Patient line length standard set with drip chamber 70 cm Free flow 300mmHg no IV ca...

Page 45: ...User Manual Technical Manual Specifications 45 of 49 Atmospheric pressure 50 kPa to 106 kPa...

Page 46: ...y this equipment and the other equipment should be observed to verify that they are operating normally The Emissions characteristics of this equipment make it suitable for use in industrial areas and...

Page 47: ...test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable the device is suitable...

Page 48: ...d at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum...

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Page 52: ...The 37Company Beeldschermweg 6F NL 3821 AH Amersfoort 31 0 33 450 72 50 www the37company com info the37company com...

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