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Fresenius Kabi Agilia Series, Инструкция по эксплуатации

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11.  TECHNICAL CHARACTERISTICS............................................................................................................

 

56

Power supply ..............................................................................................................................................

 

56 

Battery ........................................................................................................................................................

 

56 

Communication port....................................................................................................................................

 

56 

Infrared communication ..............................................................................................................................

 

56 

Compliance.................................................................................................................................................

 

56 

Dimensions - Weight...................................................................................................................................

 

57 

Trumpet curves...........................................................................................................................................

 

57

12.  GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ..........................................................

 

59

Electromagnetic emissions - Table 201......................................................................................................

 

59 

Electromagnetic immunity - Table 202 .......................................................................................................

 

59 

Electromagnetic immunity - Table 204 .......................................................................................................

 

60 

Recommended separation distances between portable and mobile RF communication equipment and 
Volumat MC Agilia - Table  206 ..................................................................................................................

 

61

13.  CLEANING AND USE CONDITIONS ........................................................................................................

 

62

Cleaning and disinfecting............................................................................................................................

 

62 

Environmental conditions............................................................................................................................

 

62 

Use of the internal battery...........................................................................................................................

 

63 

Recommendations......................................................................................................................................

 

64 

Special recommendations linked to the use of Volumat Lines: ..................................................................

 

64

14.  SERVICES..................................................................................................................................................

 

66

Conditions of guarantee..............................................................................................................................

 

66 

Quality control.............................................................................................................................................

 

66 

Preventive maintenance .............................................................................................................................

 

66 

Servicing .....................................................................................................................................................

 

66 

Data racks, accessories and maintenance tools ........................................................................................

 

67

Data 

management

 . ....................................................................................................................................

 

68

M

aintenance CD and 

tools .........................................................................................................................

 

68

Содержание Agilia Series

Страница 1: ...Volumat MC Agilia Volumetric Infusion Pump Instructions for Use...

Страница 2: ...Special features 27 General operations 30 History 32 5 DISPLAY AND SYMBOLS 36 6 ALARMS AND SAFETY FEATURES 39 7 MENU 42 Permanent menu 42 Menu selected in option mode 43 8 OPTIONS 45 9 USER TEST 50 10...

Страница 3: ...4 60 Recommended separation distances between portable and mobile RF communication equipment and Volumat MC Agilia Table 206 61 13 CLEANING AND USE CONDITIONS 62 Cleaning and disinfecting 62 Environme...

Страница 4: ...s are defined in a drug library drug name default flow rate units and values authorised infusion modes authorised boluses and bolus parameters maximum flow rate and soft limit values etc The drug libr...

Страница 5: ...ease contact our After Sales Department The pump must be used in a horizontal and stable position to work correctly The physiological effects of medicine can be influenced by the characteristics of th...

Страница 6: ...n 1 Handle 5 Infrared cell 9 Fixing button 2 Pump door 6 Mains power 10 Drop sensor connection socket 3 Door lever 7 Communication port and DC power input output 4 Assembly bolt 8 Fixing clamp 1 2 3 8...

Страница 7: ...E 12 SILENCE ALARM 18 Indicator lights LEDs 24 ON OFF 13 MENU 19 Fast decrement 25 Monitoring screen 14 Graphic Function 20 Decrement see page 12 15 Correction Back 21 Increment 16 STOP PAUSE 22 Fast...

Страница 8: ...rder When devices are stacked together on a pole the assembly bolts must be in the closed position When two Agilia devices are stacked together the Agilia Duo accessory can be used to centralise the p...

Страница 9: ...l position n Unscrew the clamp screw A and disengage the device from the pole Push the fixing button B o Fold the fixing clamp against the pump This is the recommended position for the fixing clamp wh...

Страница 10: ...ttle with its associated infusion line according to local facility procedures Caution The infusion set and the solution container must be in normal temperature conditions 18 30 C Purging the set used...

Страница 11: ...sitioned to the right green and the blue clamp is positioned in front of the clamp guide blue 2 Insert the green connector in the green slot 3 Position the blue clamp in its blue slot and then push th...

Страница 12: ...progress Infusion indicator Speed is related to flow rate VI Volume infused It increases during infusion To clear it press the key then select ml Battery level Pressure level The arrow indicates the p...

Страница 13: ...g must be the closest less or equal possible to the actual volume of the container All added or removed volumes must be taken into account including the volumes of fluids contained in the set and lost...

Страница 14: ...ows to select ml h Press Enter In the Infusion mode screen use the arrows to select a new infusion mode then press OK Note New is displayed on the screen if you choose the current mode Press this key...

Страница 15: ...et the drop sensor and restart the pump Note 2 When no more drops are detected it indicates that the container is empty The infusion will be stopped and an alarm generated Drops minute mode This infus...

Страница 16: ...the total infusion time in minutes with and in hours with and Confirm by pressing OK Adjust the rise time in minutes and in hours with the arrows Confirm by pressing OK Do the same for the fall time...

Страница 17: ...ence by selecting end for the last volume to be infused Check the sequential programming and confirm with OK Press Start to start the infusion Changes made in a sequential program become effective onl...

Страница 18: ...Press OK to confirm the parameters of the primary mode and access the secondary mode 1 Define the infusion 2 Secondary infusion start In V R mode use the arrows to select the secondary volume to be in...

Страница 19: ...eters of the primary infusion Note at the end of the secondary infusion the end of infusion pre alarm is not activated it is therefore recommended to adjust carefully the VTBI of the secondary infusio...

Страница 20: ...Use the arrows to select the dilution units Note You can select unit ml or unit Xml For the list of units see page 55 These units are preselected in the Ward option Par 20 see page 48 Press OK to val...

Страница 21: ...flow rate unit of mg kg h Weight adjustment or mg m2 h Surface area adjustment type The default weight is set in the Ward option Par 23 see page 48 Select a value Press OK to validate your choice 6 Vo...

Страница 22: ...set according to local facility procedures Press Start to initiate the infusion Loading dose Once the parameters are entered a loading dose can be infused Note This operation is available in dose rate...

Страница 23: ...is deleted Press Start to continue with the infusion Answer the question Continue If you press no the loading dose is deleted Press Start to continue with the infusion If you press Start the loading...

Страница 24: ...ection Press the key to display the Infusion mode screen If it does not appear at first place use the arrows to select DR Press Enter In the Infusion mode screen use the arrows to select a new infusio...

Страница 25: ...hut down the pump set the drop sensor and restart the pump Note 2 When no more drops are detected it indicates that the container is empty The infusion will be stopped and an alarm generated Drug labe...

Страница 26: ...e infusion provided press OK Infusion adjustments can be made as described in Operations on page 13 Note Fields and selected values may be limited according to drug parameters defined by the Vigilant...

Страница 27: ...screen appears Go to step 1 Press the key Select Programmed bolus in the menu Press Enter 1 Bolus unit 2 Bolus parameters Select the bolus unit Note This screen is displayed only in Dose rate mode Ad...

Страница 28: ...cclusion pressure level is set to its maximum value 750 mmHg Manual bolus To start a bolus press twice on the key one short press then one continuous press activates bolus check volume infused on scre...

Страница 29: ...hout having to open the pump door Press the key to reach See air bubble function Press OK to confirm or C to cancel the selection Press the key continuously to force the air out of the pump Note This...

Страница 30: ...flow rate values by pressing OK for each value and finally Start Press the key to interrupt the infusion Press the key continuously until the Switch off screen disappears To disconnect the pump disco...

Страница 31: ...on can be defined from the pressure management menu Press the key use the selection keys and enter button to access the Pressure management parameters Maximum pressure DPS Use the selection keys to de...

Страница 32: ...Circle Pressure history Curve Flow rate history Loop n Go to more detailed period Loop o Go to less detailed period Right arrow p Displace the event marker to the right side Left arrow q Displace the...

Страница 33: ...ing infusion The history is cancelled on drug change and patient change The history runs over 2 hours Note On boluses and purge the pressure limit alarms are increased to their maximum level Example o...

Страница 34: ...e pre programmed before installing the tubing set Switch on the device door closed and without set and select the prog button Infusion adjustments can be made as described in Operations on page 13 Whe...

Страница 35: ...for more details see page 15 and page 25 and to detect the container end Using a drop sensor is recommended if the actual volume of the container bag or bottle is not known accurately 1 Connect the dr...

Страница 36: ...attery life Appears when the device is operating on battery Three different levels of charge are symbolised Indicator lights Mains When the device is attached to an active mains supply the icon is a c...

Страница 37: ...values Note Fast increment and decrement keys have been programmed with different levels corresponding to standardised volumes of bags and bottles Fast increment key Increment key Decrement key Fast d...

Страница 38: ...ser Volume to be infused Patient Battery life Macro Micro History Programming mode Maintenance Sound level Date time Locking keyboard Pause Drug library Night mode Warning OTHER Drops per minute This...

Страница 39: ...r sensor Check set installation in front of air sensor and close the door Air bubble Alarm YES At start up or stop mode air bubble detected Remove air bubble by priming set Air alarm Alarm YES During...

Страница 40: ...too low Check the roller clamp Check the container and line Check the container height Check air inlet cap if a bottle is used folded line Pressure drop DPS Warning NO Pressure drop in infusion line...

Страница 41: ...drop sensor is compulsory see page 48 During infusion or stop mode drop sensor not connected Connect the drop sensor to the pump and the drip chamber see page 35 Underflow Alarm YES Flow rate detecte...

Страница 42: ...ion New setting Volume infused Total infused volume Clearing of volume infused Pressure Pressure limit adjustment and DPS mode activation Pressure limit DPS mode activation Battery life Display of bat...

Страница 43: ...ate from 0 1 to 100 ml h values with one decimal Date time Date and time programming dd mm yyyy h min Night mode Reduces the brightness of the display and light indicators For night mode configuration...

Страница 44: ...ody surface when the unit is in m2 Drug library Function accessible in STOP mode only Information on preselected drug library Library name author drugs number List of drugs with predefined parameters...

Страница 45: ...splayed on the screen Battery Permanent display of battery symbol Pressure Display of pressure symbol Priority for Vigilant logo Vigilant logo is prior to pressure symbol User 2 Menu options Choice of...

Страница 46: ...essure is below this level If DPS YES Increase threshold Select a pressure level an indication is generated if pressure is above this level compared to the average pressure of the set Note For details...

Страница 47: ...d secondary mode Macro infusion ml h Micro infusion ml h Par 9 Bolus and loading dose rates Manual bolus Maxi macro ml h Maxi micro ml h Storage select option to store last bolus rates Macro flow rate...

Страница 48: ...een Same therapy screen appears to restart infusion with last parameters at the end of infusion This function is available in Dose Rate mode Par 27 Air parameters Macro parameters see below Micro para...

Страница 49: ...s Duration from 0 to 30 min before the end of the infusion Note Adjusting down to 0 disabling is possible with Partner Agilia software only Volume from 0 to 15 of remaining VTBI Volume from 0 to 50 ml...

Страница 50: ...oor and check message air bubble 4 Remove set Fill set with liquid Install set incorrectly with pumping segment outside the pump check message Install set 5 Re install set correctly as described in th...

Страница 51: ...rom 100 to 1500 ml h Infusion rate for a Secondary infusion Macro From 1 to 1000 ml h with 1 ml h increments Maximum infusion rate can be configured in ward option Par 4 page 47 Micro From 0 1 to 1000...

Страница 52: ...iological reasons unless local policy or regulation may be applicable The set should be disconnected from the IV site according to local facility procedures Setting range Patient data Weight kg Increm...

Страница 53: ...e alarm level A 50 mmHg below maximum pressure Note If max pressure is set to 50 mmHg then the pre alarm is not activated 3 levels mode High 750 mmHg These values are given as examples and can be conf...

Страница 54: ...V R R is modified and T is calculated according to T V R Modify R T is calculated according to T V R T R Modify T V is calculated according to V R x T R is modified and T is calculated according to T...

Страница 55: ...h kcal kg h kcal kg 24h Conversion rules 1 unit 1000 n unit 1 m unit 1000 unit 1 k unit 1000 unit 1 unit h 24 unit 24h 1 unit min 60 unit h ml h unit kg h dose rate x kg weight unit ml dilution Conver...

Страница 56: ...x 1AT accessible in the battery compartment External power supply 9 VDC Power 15 W Via a specific Fresenius Kabi accessory connected to an 8 pin connector Characteristics 7 4 V 2 2 Ah Li ion battery W...

Страница 57: ...2 5 11 19 31 minutes observation windows Flow rate Time curves start up and instantaneous flow rate volume is measured every 30 seconds 1 ml h 1 ml h 25 ml h 25 ml h Observation windows minutes varian...

Страница 58: ...0 5 0 5 10 15 Accuracy upper limit 5 Accuracy lower limit 5 11 5 2 19 31 Time minutes Flow rate ml h 20 0 20 40 60 80 100 120 140 160 180 200 0 20 40 60 80 100 120 Programmed flow rate 0 0 20 0 40 0 6...

Страница 59: ...l precautions must be taken such as anti static material usage preliminary user discharge and the wearing of anti static clothing Electrical fast Transient burst IEC 61000 4 4 2 kV for power supply li...

Страница 60: ...y be necessary such as re orienting or re locating Volumat MC Agilia or install magnetic shielding b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Immunity test...

Страница 61: ...ting of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the highest frequency range applies Note 2 These guidelines may no...

Страница 62: ...OCLAVE or IMMERSE the device Do not let liquids enter the device s casing DO NOT USE TRICHLOROETHYLENE DICHLOROETHYLENE AMMONIA AMMONIUM CHLORIDE CHLORINE and AROMATIC HYDROCARBON ETHYLENE DICHLORIDE...

Страница 63: ...ce connected to the mains for at least 8 hours device off You can also recharge a Lithium ion battery whenever convenient without observing the full charge discharge cycle that is required to get full...

Страница 64: ...erneath the device Do not exceed the permitted voltage on the different external connections The pump should be used with accessories listed on page 67 only Excessive lowering of pressure in the line...

Страница 65: ...itable for the fluid or drug to be administered The infusion set may be equipped with ports K nect needle free access or 3 way stopcock These ports should be accessed by respecting aseptic procedures...

Страница 66: ...e performed by an experienced technician and are not covered by any contract or agreement provided by Fresenius Kabi Preventive maintenance To ensure normal performance of the device it is recommended...

Страница 67: ...nces 073494 Nurse call Agilia Nurse call cable 4000 V isolated 073496 Link 4 Agilia Rack 4 slots for power centralisation 073480 Link 6 Agilia Rack 6 slots for power centralisation 073481 Link 8 Agili...

Страница 68: ...panies This user guide may not be reproduced in whole or in part without the written consent of Fresenius Kabi Australia Pty Limited Vigilant and Agilia are registered trademarks in the name of Fresen...

Страница 69: ...69 Notes...

Страница 70: ...Fresenius Kabi Australia Pty Limited 964 Pacific Highway Pymble NSW 2073 Tel 1300 732 001 Fax 1300 304 384 www fresenius kabi com au PM2010 218...

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