Injectomat mc agilia инструкция на русском

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• Syringe PumpInstructions for Use

  Injectomat Agilia

• 21. INTRODUCTION
  …………………………………………………………………………………………………………………………
  4Intended use
  ……………………………………………………………………………………………………………………………….
  4Precautions to be taken
  ………………………………………………………………………………………………………………..
  4

  2. DESCRIPTION OF INJECTOMAT AGILIA
  …………………………………………………………………………………..
  5

  3. OPERATIONS FOR
  USE……………………………………………………………………………………………………………..
  7

  4. DISPLAY AND
  SYMBOLS………………………………………………………………………………………………………….
  12

  5. ALARM AND SAF

  6. MENU ………………Permanent menu .Menu to be selecte

  7. OPTION……………

  8. DRUGS…………….Introduction ……….Infusion mode:
  VolDisplay and symboSafety features andService Options …Drug
  library ……….

  9. USER TEST………

  10. PERFORMANCESRates range ………Volume Limit
  ……..Volume/Time……..Syringe list ………..Accuracy
  …………..Programmable pauPressure managemOcclusion alarm
  re

  11. TECHNICAL CHAElectrical powers..Battery
  ……………..Communication poInfrared
  communicCompliance……….Dimensions — WeigTrumpet curves….

  12. GUIDANCE AND MElectromagnetic emElectromagnetic
  imElectromagnetic imRecommended seInjectomat Agilia

  Contents2309-11_nu_injectomat_agilia_INT

  ETY FEATURES
  …………………………………………………………………………………………….
  14

  ………………………………………………………………………………………………………………………
  16

  ………………………………………………………………………………………………………………………
  16d in option
  mode……………………………………………………………………………………………..
  17

  ………………………………………………………………………………………………………………………
  18

  ………………………………………………………………………………………………………………………
  20

  ………………………………………………………………………………………………………………………
  20ume/time and limit volume
  ………………………………………………………………………………..
  21ls…………………………………………………………………………………………………………………..
  23 warnings
  ………………………………………………………………………………………………………
  23

  ………………………………………………………………………………………………………………………
  23

  ………………………………………………………………………………………………………………………
  24

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  25

  …………………………………………………………………………………………………………………….
  26………………………………………………………………………………………………………………………
  26………………………………………………………………………………………………………………………
  26………………………………………………………………………………………………………………………
  26………………………………………………………………………………………………………………………
  27………………………………………………………………………………………………………………………
  27se
  …………………………………………………………………………………………………………………
  27ent
  ……………………………………………………………………………………………………………….
  28

  sponse time and Bolus volume at occlusion release
  ……………………………………………. 29

  RACTERISTICS………………………………………………………………………………………………
  30………………………………………………………………………………………………………………………
  30………………………………………………………………………………………………………………………
  30rt……………………………………………………………………………………………………………………
  30ation
  ………………………………………………………………………………………………………………
  30………………………………………………………………………………………………………………………
  30ht…………………………………………………………………………………………………………………..
  31………………………………………………………………………………………………………………………
  31

  ANUFACTURERS DECLARATION ON EMC
  ………………………………………………….
  32issions — Table
  201…………………………………………………………………………………………
  32

  munity — Table 202
  ………………………………………………………………………………………….
  32munity — Table 204
  ………………………………………………………………………………………….
  33

  paration distances between portable and mobile RF communication
  equipment and — Table
  206…………………………………………………………………………………………………….
  34

• 2309-11_nu_injectomat_agilia

  13. CLEANING AND USE CONDITIONS
  …………………………………………………………………………………………..
  35Cleaning and
  disinfecting…………………………………………………………………………………………………………….
  35Environmental
  conditions…………………………………………………………………………………………………………….
  35Use of the internal
  battery……………………………………………………………………………………………………………
  35Recommendations……………………………………………………………………………………………………………………..
  36

  14.
  SERVICES………………………………………………………………………………………………………………………………..
  37Conditions of guarQuality control……Preventive
  maintenServicing …………..Data racks, access_INT 3

  antee………………………………………………………………………………………………………………
  37………………………………………………………………………………………………………………………
  37ance
  ……………………………………………………………………………………………………………..
  37

  ………………………………………………………………………………………………………………………
  37ories and maintenance tools
  …………………………………………………………………………….
  38

• 41. Introduction

  Injectomat Agilia is the first syringe pump of the Agilia range,
  our new generation of infusion pump.It is simple to use and
  training is fast thanks to its ergonomics and interactive
  screens.Very intuitive, Injectomat Agilia was also developed to
  promote safety. The pusher protection «Push-guard»offers a maximum
  safety in case the pump falls.The monitoring of pressure as well as
  many safety features optimize the operation of Injectomat
  Agilia.Robust and adaptable thanks to a wide choice of options,
  Injectomat Agilia makes it possible to answer thewhole of your
  needs.

  Intended use Injectomat Agilia is This pump must be

  Precautions to The symbol vis Injectomat Agilia wof the medical
  devicesradiations avoids the uis placed near devicedistances
  between equ The device must noshould always be used The device can
  be etc. If you wish to use tmust be used in a horiz The
  physiological esyringe. Check that thealarm setting times in r In
  case of unexpecalarm, to stop infusionChapter 6). In case whthe
  user should consid2309-11_nu_injectomat_agilia_INT

  a syringe pump for intravenous drug infusion. used by
  professionals working in hospitals.

  be takenible on the device, recommends this user guide should be
  completely read.as tested in accordance with the applicable
  standards of electromagnetic compatibility

  . Its immunity makes it possible to ensure correct operation.
  The limitation of the emittedndesirable interference with other
  equipments such EEG, ECG, If Injectomat Agilias like surgical
  equipment HF, X-rays, NMR, mobile phones, Wifi points…,
  minimalipment are essential (see page 33).t be used in presence of
  inflammable anaesthetic agents due to a risk of explosion. It away
  from all risk areas.disturbed by pressure or pressure variations,
  mechanical shocks, heat ignition sources,he devices in a specific
  condition, please contact our After-Sales Department. The pumpontal
  and stable position to work correctly.

  ffects of medicine can be influenced by the characteristics of
  the device and disposabley are compatible with prescriptions, the
  characteristics of trumpet curves and occlusionelation to the
  programmed flow rate.ted situation in the pump controls or
  environment, the state of the art safe-design is to and to display
  an error code. The user is invited to be aware of those alarms
  (seeere the device is used to deliver life sustaining therapies,
  like short half-life medications,er adequate provisions for back-up
  therapy delivery solutions.

• 2309-11_nu_injectomat_agilia

  2. Description of Injectomat Agilia

  1 — Syringe barrel cl2 — Syringe flange c3 — Pusher4 —
  «Push-guard»

  10_INT 5

  asp 5 — Handle 9 — Mains connectionradle 6 — Assembly bolt 10 —
  Fixing button

  7 — Infrared cell 11 — «Swinglock clamp»8 — Communication
  port

  and DC power input-output

  11 9 8

  7

  65

  1 2 3 4

• 612 — Mains warning13 — Screen14 — Silence Alarm15 — ON/OFF16 —
  Bolus or Prime

  15 16

  122309-11_nu_injectomat_agilia_INT

  17 — 22 — Validationto Value selection 23 — Stop: infusion
  stop

  20 — 24 — Menu / Exit21 — Functioning, pre-alarm

  and alarm warnings

  17 1918

  24232221

  20

  13 14

• 2309-11_nu_injectomat_agilia

  3. Operations for use

  Installation of Injectomat Agilia

  Injectomat Agilia can be used on a table, pole or rail.

  On table

  Two » Injectomat Agassembled together _INT 7

  On pole On rail

  ilia » maximum can be during infusion

  Three devices maximum can be assembled on a pole or during
  transportation

  When the devices are assembled, the assembly bolts must be in
  closed position.

  3 pumps on a pole: at least 2 fixing clamps must be locked.

• 8Using the fixing clamp

  The swinglock clamp is only orientable when closed against the
  pump. It is maintained in its vertical or horizontal position with
  the fixing button. The following images show how to modify the pump
  installation, from a pole to a rail position.

  Unscrew the clamdevice from the p

  Rotate the fixing c90 degrees.

  A

  B2309-11_nu_injectomat_agilia_INT

  p screw (A) and disengage the ole. Push the fixing button
  (B).

  Fold the fixing clamp against the pump. This is the recommended
  position for the swinglock clamp when the device is placed on a
  flat surface.

  lamp downward through Move the fixing clamp outward (A). The
  fixing button is released automatically. Engage the device on the
  rail and use the clamp screw (B) to secure it.

  BA

• 2309-11_nu_injectomat_agilia

  Installing a syringe (patient not connected)

  Connect the extension set to the syringe according to proper
  practices.Check that there is no air bubble left in the
  syringe.

  Place the syringe in its cradle, the flanges correctly inserted
  in the provided slot . Secure the syringe with the syringe barrel
  clasp.

  Move the pusher f_INT 9

  orward to the syringe head. Check the general installation.

• 10

  1 — Operations for use 2 — Syringe selection

  Check Injectomat Connect the powersource and to the syrinlights
  up. Press the ke For the first startupinternal battery. Press the
  kpump OFF. To disconsupply, disconnect maunplugging the device

  3 — Prime

  Connect the extens Check the patient i To start the prime, pone
  short press, then air bubbles are elimina To stop the prime,
  Connect the patienNote: During priming, set to its maximum
  va2309-11_nu_injectomat_agilia_INT

  Agilia is not damaged. supply cord to the main ge pump: the
  mains warning

  y to turn the pump ON., refer on page 35: Use of the

  ey continuously to turn the nect the device from mains ins-wise
  plug first before power inlet.

  The installed syringe must correspond to the syringe displayed.
  OK: to confirm syringe,or, C: to change syringe selection then
  confirm.

  4 — Flow rate selection/start

  ion set to the syringe.s not connected.ress the key twice:

  one continuous press until all ted from the line.

  release the key.t.the occlusion pressure level is lue (900
  mmHg).

  Select flow rate. Check the infusion parameters (syringe, flow
  rate, ). Start: press the key to start infusion.

• 2309-11_nu_injectomat_agilia

  Silence alarm Access to the menu

  Press the key until the flow rate

  te (ml/h) and confirm.e occlusion pressure level is set (900
  mmHg).

  Press the key: the infusion stops. Start infusion pressing the
  key. Pause programming: press the key twice. Select the pause
  duration. The pause can also be programmed from the menu. When the
  pause duration is finished, press the key to start infusion.

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• 12

  4. Display and symbols

  Injectomat Agilia displays the infusion parameters in progress
  through specific symbols.

  Continuous display

  Infusion in progressMain indicator lights provide information on
  status of the infusion in progress.

  Pause The symbol flashes when activated.

  Indicator lights

  Help

  Alarms and safeties features

  or2309-11_nu_injectomat_agilia_INT

  Battery lifeAppears when the device is operating on
  battery.Three different levels of charge are symbolized.

  Mainsconstant yellow

  Main indicator lights provide information on status of the
  infusion in progress.

  Infusion in progressflashing green

  Pre-alarmflashing orange

  Alarmflashing red

  Start

  These symbols help the user in programming the pump.

  Validation

  Access to function

  Previous screen

  Cancel

  Change syringe selection

  Selected

  Not selected

  Mains disconnection alarm

  Main symbols for alarm and safety features.Pressure increase

  Pressure drop

• 2309-11_nu_injectomat_agilia

  Selection keys

  Fast increment key

  Increment key

  MENU_INT 13

  Keys for selection of flow rate(ml/h), volume limit (ml),
  values.

  Decrement key

  Fast decrement key

  Fast access to maximum values +

  Fast access to minimum values +

  Infused volume

  The menu is dedicated to infusion options that are selected by
  the user.

  Battery life

  Keyboard locking

  Maintenance

  Date/Hour

  Data event log

  Syringe

  Sound level

  Volume limit

  Volume/Time

  Pause

  Pressure

  Night mode

• 14

  5. Alarm and safety features

  Injectomat Agilia has a continuous inspection system that
  functions as soon as the pump is in use. Visualmessages are
  displayed to understand the alarm cause. Press on to silence alarm
  according to tablebelow.

  Control Visual message Infusion stop

  Silence alarm Activation

  Battery

  BATTERPRE-ALA

  BATTER

  Mains POWER DISCON

  Installed syringe

  SYRINGINSTALL

  Infusion

  END OF PRE-ALA

  END OF ALARM

  Volume Limit

  END OF VOLUMEPREALA

  END OF VOLUMEThe max2309-11_nu_injectomat_agilia_INT

  Y RM

  NO YES Low battery. Note: Battery alarm activated when at least
  30 minutes battery life remaining. (If the battery has previously
  been charged).

  Y ALARM YES YES (2 min) Discharged battery.Note: The pump will
  turn OFF automatically within 5 minutes. Connect the pump to the
  mains.

  NECTIONNO YES Mains disconnection. (Alarm Selection :

  refer [Par 13], page 19.E ATION

  YES YES (2 min) Pusher or syringe barrel clasp or flange
  detection.

  YES YES (2 min) Syringe not correctly installed.Note: The alarm
  goes OFF as soon as the installation is correct. A silence alarm of
  2 min is automatically activated when the pump is switched on.

  INFUSION RM

  NO YES The pre-alarm is triggered when the time before end of
  infusion is less than 5 min and the remaining volume in the syringe
  is less than 10% of the syringe capacity.

  INFUSION YES YES Empty syringe.

  LIMIT RM

  NO YES The pre-alarm is triggered when the time before end of
  volume limit is less than 5 min and the remaining volume in the
  syringe is less than 10% of the syringe capacity.

  LIMIT ALARM

  Stop/KVO/continuous

  YES (*) Limit volume reached.(*) Silence duration for KVO: page
  18

  imum volume that may be infused under single fault condition is
  1 ml.

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• 2309-11_nu_injectomat_agilia

  V/T

  END OF VOL./TIME PREALARM

  NO YES 5 minutes before V/T alarm or 10% of the total syringe
  capacity.

  END OF VOL./TIME ALARM

  Stop/KVO/ YES (*) V/T limit reached.

  Pressure

  OCCLUSPRE-ALAOCCLUS

  PRESSU

  PRESSUINCREA

  Other alarms

  PLUNGEALARMDISENGMECHANALARMFLASHINRATE

  NO VALI

  Audible

  STOP m

  Er — mes(Er01, ErIn case ostop the persists wtechnicia

  Control Visual message Infusion stop

  Silence alarm Activation_INT 15

  continuous mode

  (*) Silence duration for KVO: page 18

  ION RM

  NO YES — 50 mmHg from the programmed limit.

  ION ALARM YES YES (2 min) Programmed limit reached.

  RE DROP NO YES Pressure drop in the infusion line.(This alarm
  can be selected in options).

  RE SE

  NO YES Pressure increase in the infusion line.(This alarm can be
  selected in options).

  R HEAD YES YES Pusher incorrectly inserted.

  AGEMENT ISM

  YES YES Disengaged mechanism.

  G FLOW NO — Flashing starts 3 seconds after no confirmation of
  selection. An audible alarm is activated 15 seconds afterwards.

  DATION NO YES Flashing starts 3 seconds after no confirmation of
  selection. An audible alarm is activated 15 seconds afterwards.

  signal — — No syringe selection > 2 minutes.

  — — Unauthorized key.

  essage — — End of pause duration.

  sage 02)

  YES — Technical alarm. Press the key.

  f malfunction alarm, note the error message (ErXX). Disconnect
  from the mains and device by pressing the OFF key (10 — 15 seconds
  can be necessary). If the alarm

  hen the device is switched on again, without use on patient,
  contact the qualified ns in your establishment or our After-Sales
  Department.

• 16

  6. Menu

  Permanent me

  Operation Key

  Access menu/previous menu:

  Select with:

  Confirm with:

  Selected / Not sel

  FunctionInfused volume

  Pressure

  Battery life

  Pause

  Locking

  SyringeDisplay only if [Par 15] «syringe display» not
  selected2309-11_nu_injectomat_agilia_INT

  nu

  ___

  ected

  Description Operation SymbolDisplay of infused volume and total
  infused volume reset

  Clear the infused volume

  Pressure limit adjustment and DPS mode activation

  Pressure limit DPS mode activation

  Battery life display Display in hour and minute for a selected
  rate

  Pause duration adjustment

  Hours and minutes adjustment

  Keyboard locking and unlocking

  LockingThe and keys are never locked.

  Brand capacity and type of the used syringe

  Syringe used

• 2309-11_nu_injectomat_agilia

  Menu to be selected in option modeFunction Description Operation
  Symbol

  Volume/TimeFunction accessible in STOP mode only

  Volume/time programming Volume Time End VTI (stop, KVO,
  continuous)

  Maintenance Information on Maintenance date

  Data Event logFunction accessible in STOP mode onlySound
  level

  Volume limitFunction accessible in STOP mode

  Date/hour

  Night modeOnly if «Manual mode» selected in Ward option [Par
  18]

  CAUTION: the menu_INT 17

  maintenance, version, functioning duration, etc.

  SN (serial number) Software version

  Up to 1500 events recorded

  Syringe Pressure limit Flow rate

  Audible level adjustment 7 accessible levels

  Volume limit programming Select VL or OFF End VL (stop, KVO,
  continuous)

  Date and hour dd/mm/yyyy h/minManual Mode change:night/day or
  day/night

  Manual mode interrupts auto-mode. Night mode is re-activated on
  next defined night cycle [Par 18]

  can change depending on the selected infusion options.

• 18

  7. Option

  Operation Key

  Options access: when device is turned off

  Option selection:

  Confirm by:

  Previous menu

  Selected / Not sel

  Selected values on us

  Option FuUser [Util 1] Sc

  Display ofsymbols

  [Util 2] MeInsertion ooptions in

  [Util 3] Co[Util 4] PrPressure mDynamic PSystem

  [Util 5] KV(Keep Vei

  [Util 7] Da[Util 8] La2309-11_nu_injectomat_agilia_INT

  ___

  ected

  e are memorized when the device is turned OFF at end of
  programming.

  nction Choice Description / reen options the different

  Battery Permanent display of battery symbol Pressure Display of
  pressure symbol Volume info. (or) Display of infused volume Time
  info. (or) Display of remaining time of infusion Battery life info.
  (or) Display of battery life Man Choice of symbol «infusion in

  progress» Moonnu options f the different the menu

  Volume limit Volume limit selection Volume/time V/T selection
  Sound level Audible signal selection Maintenance Maintenance
  selection Data event log Display of event log Date/hour Date/hour
  selection

  ntrast Screen contrast adjustmentessure

  ode Variable mode (with maximum and limit)

  3 level mode (with thresholds and limit)

  ressure DPS with drop threshold and pressure increase
  threshold

  No DPS mode activation

  On Open)

  KVO1: OFF, 0.1 to 5 ml/h KVO2: OFF, 0.1 to 5 ml/h Continuous:
  YES/NO

  Silence duration: delay for end of V/T or end of VL
  re-activation alarm (60 minutes maximum)

  Continuous mode: at the end of V/T or VL mode, infusion
  continues at the current selected rate.

  te/hour Date selection: dd/mm/yyyy Hour selection: h/minnguage
  Franais / English

  tamnguyenHighlight

  tamnguyenHighlight

• 2309-11_nu_injectomat_agilia

  Option Functions Option choiceWard Ward code Code: 0000 (default
  code: 0200).

  [Par 1] Beep level 1 tonality 2 tonalities Key Bip Preventive
  silence : refer page 11 «Silence alarm» Silence duration : between
  2 alarm bips (0 to 5 seconds)

  [Par 2] So

  [Par 3] In

  [Par 4] M

  [Par 5] Sy

  [Par 6] Sy

  [Par 7] In

  [Par 8] Em

  [Par 9] Bo

  [Par 10] W

  [Par 11] B

  [Par 12] U

  [Par 13] Mdisconne[Par 14] B

  [Par 15] Sdisplay [Par 18] N! manual mon
  auto-mre-activatecycle

  Maint. Maintena_INT 19

  und level 7 available audible levels.itial rate If option
  selected: on turning on the pump, the initial rate will be

  the last selected during the last infusion. If option not
  selected : 0.00 ml/h display.

  aximum rate Per syringe capacity (50cc / 30cc )ringe selection
  Auto confirmation of the syringe or not

  (available only with a single syringe selected — refer to [Par
  6])ringes Available syringe list (activation/disactivation).

  fusion start Mandatory prime or advised primepty syringe «OK»
  flashes at end of infusion pre-alarm or alarm. If confirmed

  the infusion goes on until the syringe is emptylus rates Per
  syringe capacity (50cc / 30cc ).ard name Ward name (press OK for
  each letter or — until reaching the last

  position).io name Biomedical name (press OK for each letter or —
  until reaching

  the last position).ser code User code: mandatory code to modify
  user optionsains supply

  ction alarm Warning beep and message «device operating on
  battery» when the pump is turned on.

  attery life Maximum battery life mode: allow the increase of the
  battery autonomy.

  yringe/ward Syringe brand and capacity or ward name display.

  ight modeode has priority

  ode. Auto-mode d next night

  Screen brightness low

  Green lights low Key beep off

  Manual mode: manual switch from one mode to another Auto mode:
  automatic switch from one mode to another according to the time
  range settings

  nce Code: please contact our technical team.

  tamnguyenHighlight

• 20

  8. Drugs

  Introduction The «drug» function makes the infusion safe,
  incorporating the drug parameters. The drug library can be created
  with our Vigilant Drug’Lib system which makes drug administration
  safe.Vigilant Drug’Lib in particular allows the drug concentration,
  default flow rate, «hard» flow rate limits (limits whichcannot be
  exceeded during the infusion) and «soft» flow rates limits (limits
  which can be exceeded during theinfusion after a user warning
  message) the permitted infusion modes (Ml/h, V/T) and the bolus
  parameter settingto be added.

  Start-up: Start-u

  3 — No drug sele

  No drug : Select «no drug» Ok: Press . set up procedure (page
  10)

  Select drug Select the drug. Ok: Press to confirm the choice of
  drug.

  nal) 5 — Select flow rate/start

  ion to the syringe.ent is not connected.ress the key twice:

  one continuous press until all ted from the line.

  release the key.t.the occlusion pressure level is lue (900
  mmHg).

  Select the flow rate with the increment keys. Check the infusion
  parameters (syringe drug name and parameters, flow rate etc.) Start
  Press to start the infusion.

• 2309-11_nu_injectomat_agilia

  Infusion mode: Volume/time and limit volumeThe infusion with a
  drug name and associated parameters can also be programmed in
  Mode/Time or LimitVolume mode.

  Start-up: Start-up procedures 1 and 2 page 10.

  3 — Drug selecti

  Select drug : Select the drug. Ok: Press to access and
  rameters.

  TION> to confirm the

  Check the infusion parameters (syringe, drug name and
  parameters, flow rate etc.) Start: Press to start the infusion.

• 22

  Access to information in the drug library

  Drug library Press

• 2309-11_nu_injectomat_agilia

  Display and symbols

  Safety feature

  Service Option

  Menu Access to the drug library Access to the drug library.

  Drug information «EYE»: Access to the drug information

  Access to drug name, concentration and drug comments which are
  modifiable with

  Soft limit

  Reset of Volume Infused and V/T and VL Parameters

  OptionService(code 0200)

  Vigilant

  Drug lib

  _INT 23

  s and warnings

  s

  Vigilant Drug’Lib.

  Flow rate limit that is allowed to be exceeded after a warning
  and being validated by the user.

  Upper soft limit exceeded Warning message that upper soft limit
  has been exceeded.

  Lower soft limit exceeded Warning message that lower soft limit
  has been exceeded.

  Confirmation that the soft limits have been passed WARNING

  The user must confirm that he/she is authorizing passing the
  soft limit.

  Warning message WARNING

  Drug changed CLEAR: VI and VL

  If a drug or concentration of drug is changed, the volume
  infused and V/T and VL parameters are reset.

  Function Choice Druglib [Par16] Selection Activation of drug
  functions and

  parameters. Storage Memorize last drug used when

  device was switched on.rary [Par17] Library stored in the device
  and modifiable

  with Vigilant Drug ‘Lib.

  High flow rate

  Low flow rate

• 24

  Drug libraryOption Function Type of option

  Loaded library

  Loading of a library is acknowledged when the instrument is
  switched on or a syringe is changed

  Vigilant Drug’Lib

  Library pwhich arwith Vigi

  Error messages

  The devi»Error mdrug
  librcompatibdevice2309-11_nu_injectomat_agilia_INT

  *

  Ok: Press to confirm change of new drug library.(*) WARNING: The
  library must be changed after disconnecting the device from the
  patient.

  arameters e modifiable lant Drug ‘Lib

  The drug library must be created using Vigilant Drug’Lib, the IV
  Medication Safety Solution by Fresenius Kabi. This software allows
  you to adjust the dilution, the authorised and default infusion
  modes, the flow rate and bolus limits (in ml/h) and can manage up
  to 50 drugs.

  ce will display essage» if the ary is not le with the

  These messages should not appear during normal operation. They
  allow the instrument to self-check consistency between the Vigilant
  Drug’ Lib parameters and the instrument infusion parameters.For
  example: If the instrument incorporates a flow rate limit of 1500
  ml/h, which is not compatible with its maximum performance (1200
  ml/h), the instrument will display an error message.

  tamnguyenHighlight

• 2309-11_nu_injectomat_agilia

  9. User test

  This protocol allows a quick check of pump functionality.

  Injectomat Agilia serial number
  (ID/N):_____________________________

  Name: ________________________________Ward:
  ________________________________Date:
  ________________________________

  Check the state of upside down), presen Connect the device key:-
  check the good funcluminous indicators.- functioning on mains Open
  the syringe bsyringe).

  Install a 50cc syrinpusher in infusion posConfirm the syringe
  an- the infusion in progre Open the syringe balarm activated.

  Close the syringe bDisengage and move and plunger head
  alarReturn pusher to infus Note the stopper p5 ml bolus: Check the
  0.5 ml. Disconnect mains OFF.The battery symbol in

  Signature_INT 25

  Actions YES NO the device: absence of impact marks and noises
  (turn the device ce of all labels as well as their legibility,
  mains lead. to the mains and press the

  tionality of the display and

  signaled by:

  arrel clasp (do not install the

  ge — syringe barrel clasp and ition.d select a flow rate of 0.1
  ml/h.ss is signaled by man or moon.

  or

  arrel clasp: syringe installation

  arrel clasp.pusher backward. Disengagement ms activated (visible
  on schemes). ion.

  osition/syringe volume and start a syringe stopper has moved to
  5 ml BOLUS lead, the mains indicator turns

  dicates a functioning on battery.

  The device is operational when all the controls are OK.

  Test OK

• 26

  10.Performances

  Rates range

  Volume Limit

  Volume/TimeFlow rate calculation programmed infusion calculated
  at 0.00001

  Syringes (ml) Infusion rateInfusion rate increment: 0.1
  ml/h.Indicated value corresponds to the initial device
  configuration and can be changed.Bolus rate

  50/60 30 20 10 5

  Infusion rate (ml/h) 0.1 to 2000.1 to 120

  0.1 to 120

  0.1 to 60

  0.1 to 60

  Bolus rate (ml/h)

  Prime rate (ml/h)

  Volume Limit (ml)

  Volume to infuse

  Infusion duration2309-11_nu_injectomat_agilia_INT

  at volume/time programming: displayed flow rate = programmed
  volume to infuse /duration, the flow rate is displayed rounded off
  at 0.05 ml/h. The real flow rate is ml/h.

  Bolus rate increment: 50 ml/h.50 to 1200

  50 to 600

  50 to600

  50 to350

  50 to250

  1200 600 600 350 250

  Syringes (ml) 0.1 ml increments.KVO (keep vein open) rate: from
  0.1 ml/h to 5 ml/h, stop or selected flow rate (continuous)
  depending on the device configuration. Note: if KVO rate exceeds
  the selected flow rate the device infuses at the selected flow
  rate.

  50/60 30 20 10 5

  From 0.1 to 999.9

  Syringes (ml) 0.1 ml increments.KVO (keep vein open) rate: from
  0.1 ml/h to 5 ml/h, stop or selected flow rate (continuous)
  depending on the device configuration. Note: if KVO rate exceeds
  the selected flow rate the device infuses at the selected flow
  rate.

  50/60 30 20 10 5

  From 0.1 to 99.9 (with 0.1 ml increments)

  From 0h01 to 96h00 (with 0h01 increments)

  tamnguyenHighlight

  tamnguyenHighlight

  tamnguyenHighlight

• 2309-11_nu_injectomat_agilia

  Syringe listInjectomat Agilia offers maximum 50 syringes of
  different types, brands and sizes.

  Accuracy

  Programmable

  Brand and type Syringe capacity (ml) This syringe list is
  indicative of most current product codes. To know the exact list of
  your product code, please contact our Sales

  50/60 30 20 10 5BD PLASTIPAK BD PLASTIPAK WWD BD PERFUSION

  BRAUN OMNIFIX

  BRAUN PERFUSOR

  FRESENIUS INJECT

  FRESENIUS MED. CA

  FRESENIUS P-SPRIT

  MONOJECT

  TERUMO

  Flow rate accuracy (

  Device accuracy

  Syringe accuracyAccuracy with back pressure of 13.33 k

  Programmable paus_INT 27

  pause

  Department. This information can be checked directly in Ward
  Option [Par 6], page 19.

  CAUTION: Fresenius Kabi cannot accept any responsibility for
  errors in flow due to modifications of the specifications of the
  syringes introduced by the manufacturer.

  OMAT RE ZE

  *) 3 %(*) with selectable syringes, following NF EN/IEC
  60601-2-24 standard.

  1 % 2 %

  Pa 3 %

  e From 1 minute to 24 h 1 minute increments.

  tamnguyenHighlight

  tamnguyenHighlight

  tamnguyenHighlight

• 28

  Pressure management (refer to user option [Util 4])

  Variable modeMaximum pressure From 500 to 900 mmHg

  50 mmHg increments.Defines the authorized maximum pressure
  during infusion.

  Limit From 100 to maximum — — — : memorization of the
  pressure

  3 levels mode

  DPS(Dynamic Pressure System)2309-11_nu_injectomat_agilia_INT

  limit at the device switch OFF.High From 250 to 900 mmHg

  — — — : memorization of the limit (high/middle/low) at the
  device switch OFF.

  Middle From 150 to 700 mmHg

  Low From 50 to 300 mmHg

  Limit Low, middle, high determined level valuesPressure increase
  Anticipates an occlusion during infusion.

  Pressure decrease

  A pressure decrease indication may be a warning of
  disconnection.

  Drop threshold From 100 to 500 mmHg Threshold — — -:
  Deactivation of

  pressure decrease management.Increase threshold From 100 to 200
  mmHg

  Accuracy: the accuracy on the pressure threshold activation is
  75 mmHg or 15%.Note: 1 bar = 750 mmHg = 1000 hPa.

  tamnguyenHighlight

• 2309-11_nu_injectomat_agilia

  Occlusion alarm response time and Bolus volume at occlusion
  releaseDevice accuracy is linked to the syringe used. Values are
  representative of used syringes during trials and aregiven as
  indicators.Syringes used: B-D Plastipak Luer Lok.B-D Plastipak and
  Luer Lok are registered trademarks of Becton Dickinson.Extension
  sets used: tyNote: No other pressu

  = Mean = Standard deviation

  Syringe

  50 ml

  1

  5

  2

  20 ml

  1

  5

  2

  Syringe

  50 ml5

  2

  20 ml5

  2

  m_INT 29

  pe SE1400Sre measuring device was connected.

  RateOcclusion alarm threshold

  Values are calculated from 10 to 20 measures.

  100 mmHg 500 mmHg 900 mmHg

  ml/h = 25 = 4 = 1h10 = 5

  = 1h40 = 10

  ml/h = 415 = 50 = 12 = 2

  = 20 = 4

  0 ml/h = 45 = 15 = 240 = 20

  = 430 = 40

  ml/h = 12 = 2 = 25 = 4

  = 40 = 6

  ml/h = 130 = 20 = 440 = 50

  = 7 = 1

  0 ml/h = 20 = 5 = 50

  = 11 = 130 = 20

  RateBolus volume at occlusion release

  Values are calculated from 20 measures after completion of the
  automatic anti-bolus function.

  100 mmHg 500 mmHg 900 mmHg

  ml/h = 0.04 ml = 0.02 ml = 0.1 ml

  = 0.04 ml = 0.15 ml

  = 0.05 ml0 ml/h = 0.04 ml = 0.016 ml

  = 0.11 ml = 0.04 ml

  = 0.15 ml = 0.07 ml

  ml/h = 0.06 ml = 0.017 ml = 0.14 ml

  = 0.07 ml = 0.25 ml

  = 0.08 ml0 ml/h = 0.05 ml = 0.015 ml

  = 0.12 ml = 0.06 ml

  = 0.16 ml = 0.07 ml

  m m m

  m m m

  m m m

  m m m

  m m m

  m m m

  m m m

  m m m

  m m m

  m m m

• 30

  11.Technical characteristics

  Electrical powers Use the main lead supplied with Injectomat
  Agilia.

  Battery Disconnect battery

  Parameters are storedthis can be update by u

  CommunicatioThe connector situatedpower and nurse call c

  Infrared commInjectomat Agilia is einformation with the AgThe
  information can th

  Compliance

  Mains power Mains supply : 100 V — 240 V ~ / 50-60 Hz with
  functional earth.

  Maximum consumption: 180 mAMaximum power 15 VA

  External power

  CharacteristicsWeightBattery life

  Battery recharge

  Nurse callSerial cableExternal powerPower output

  Safety of ElectroMedEquipmentsEMC
  (ElectroMagnetCompatibility)2309-11_nu_injectomat_agilia_INT

  before opening device. Avoid short circuits and excessive
  temperatures. in the device flash memory. If the battery is totally
  discharged, the date may be lost butser following mains power
  connection.

  n port at the back of the device allows different functions
  using the communication, mains

  ables.

  unicationquipped with an infrared cell located at the back of
  the device. It permits exchange ofilia Link+ rack.en be transmitted
  by dedicated communication cables.

  consumption:Protective fuses: T2AH 250 V included in power
  supply.

  9 Volts continuous / Power > 15 Watts.Via a specific
  Fresenius Kabi accessory connected to an 8 pins connector.

  6 V 1.8 Ah — NiMH battery.Approximately 140 gMinimum 10 h at a
  rate of 5 ml/h.Minimum 5 h at a rate of 120 ml/h.Pump OFF: < 5
  h. Pump ON: < 15 h.

  Nurse call relay output command.TTL output.9 V / 15 W input.5 V
  / 150 mA to power Nurse Call or Serial Link accessories.

  Conform to the 93/42/CE Medical Directive.

  IP22 Protection against splashing liquid.

  Protection against leakage current:Defibrillation-proof type CF
  applied part.

  Protection against electric shocks: class II.

  Functional earth.

  ical Conform to EN/IEC 60601-1 and EN/IEC 60601-2-24.

  ic Conform to EN/IEC 60601-1-2 and EN/IEC 60601-2-24.

  tamnguyenHighlight

  tamnguyenHighlight

• 2309-11_nu_injectomat_agilia

  Dimensions — Weight

  Trumpet curveTrumpet curves demoncombination.The test protocol
  usedplease refer to this pubThis graph is therefore overall
  performance.

  H / L / W 135 x 345 x 160 mm

  Weight around 2.1 Kg

  Screen size 70 x 35 mm

  Tru

  O

  % v

  ariance fro

  m

  no

  min

  al flo

  w r

  ate

  O

  % v

  ariance fro

  m

  no

  min

  al flo

  w r

  ate

  O

  % v

  ariance fro

  m

  no

  min

  al flo

  w r

  ate_INT 31

  sstrate the evolution of the minimum and maximum variance of the
  Syringe/Syringe-Pump

  to obtain these results is described in the EN/IEC 60601-2-24.
  For further information,lication.representative of syringes used
  during trials and serve as an indication only of the pump’s

  mpet curves Start-up and instantaneous nominate curves

  Used syringes: B-D Plastipak 50 ml Luer Lok.

  bservation window (minutes)

  Flow rate 1 ml/h

  Maximum authorized %

  Minimum authorized %

  Max

  Min

  bservation window (minutes)

  Flow rate 5 ml/h

  Maximum authorized %

  Minimum authorized %

  Max

  Min

  bservation window (minutes)

  Flow rate 20 ml/h

  Maximum authorized %

  Minimum authorized %

  Max

  Min

  Flo

  w r

  ate

  (m

  l/h

  ) Flow rate 1 ml/h

  Duration (minutes)

  Flo

  w r

  ate

  (m

  l/h

  ) Flow rate 5 ml/h

  Duration (minutes)

  Flo

  w r

  ate

  (m

  l/h

  ) Flow rate 20 ml/h

  Duration (minutes)

• 32

  12.Guidance and manufacturers declaration on EMC

  Electromagnetic emissions — Table 201Injectomat Agilia is
  intended for use in the electromagnetic environment specified
  below. The user ofInjectomat Agilia should make sure it is used in
  such an environment.

  ElectromagneInjectomat Agilia is inThe user of Injectomat

  Emissions testCompliance

  obtained by the device

  Electromagnetic environment — guidance

  RF emissionsCISPR 11

  Group 1 Injectomat Agilia uses RF energy only for its internal
  function. Therefore, its RF emissions are

  RF emissionsCISPR 11

  Harmonic emissionsIEC 61000-3-2

  Voltage fluctuationsFlicker emissionsIEC 61000-3-3

  D

  Immunity testIE

  IE

  Electrostatic Discharge (ESD)IEC 61000-4-2

  Electrical fastTransient / burstIEC 61000-4-4

  2

  for in

  SurgeIEC 61000-4-5 dif

  co

  Voltage dips, short interruptions and voltage variations on
  power supply input linesIEC 61000-4-11

  (>

  (6

  (3f

  (>

  Power frequency (50/60 Hz)magnetic fieldIEC 61000-4-8

  Note: Ut is the a/c. main
  volta2309-11_nu_injectomat_agilia_INT

  tic immunity — Table 202tended for use in the electromagnetic
  environment specified below. Agilia should make sure it is used in
  such environment.

  very low and are not likely to cause any interference in nearby
  electronic equipment.

  Class B Injectomat Agilia is suitable for use in all
  establishments, including domestic and hospital

  establishments and those directly connected to the public
  low-voltage power supply network that supplies buildings used for
  domestic purposes.

  Class A

  oes not apply

  C 60601-1-2C 60601-2-24Test level

  Compliance level obtained by the

  deviceElectromagnetic environment — guidance

  8 kV contact 15 kV air

  8 kV contact 15 kV air

  Coatings of the floors out of wooden, tilling, and concrete,
  with a relative humidity level at least 30 %, make it possible to
  guarantee the level of necessary conformity. If it is not possible
  to guarantee this environment, additional precautions must be
  taken, such as: anti-static material usage, preliminary user
  discharge and the wearing of anti-static clothing.

  kV for power supply lines

  1 kV put output lines

  2 kV for power supply lines

  1 kV for input output lines

  Mains power quality should be that of a typical domestic,
  commercial or hospital environment.

  1 kV ferential mode

  2 kVmmon mode

  1 kV differential mode

  2 kV common mode

  Mains power quality should be that of a typical domestic,
  commercial or hospital environment.

  < 5 % Ut95 % dip in Ut)for 0.5 cycle

  < 5 % Ut(> 95 % dip in Ut)

  for 0.5 cycle

  Mains power quality should be that of a typical domestic,
  commercial or hospital environment.

  For short and long interruptions (< than battery life) of
  power mains, the internal battery provides the continuity of
  service.

  40 % Ut0 % dip in Ut)for 5 cycles

  40 % Ut(60 % dip in Ut)

  for 5 cycles

  70 % Ut0 % dip in Ut)or 25 cycles

  70 % Ut(30 % dip in Ut)

  for 25 cycles

  < 5 % Ut95 % dip in Ut)

  for 5 sec

  < 5 % Ut(> 95 % dip in Ut)

  for 5 sec

  400 A / m 400 A / m If necessary, the power magnetic field
  should be measured in the intended installation location to assure
  that it is lower than compliance level.If the measured field in the
  location where the Injectomat Agilia is used exceeds the applicable
  magnetic field compliance level above, the Injectomat Agilia should
  be observed to verify normal operation. If abnormal performance is
  observed, additional measures may be necessary, such as
  re-orienting or re-locating Injectomat Agilia, or install magnetic
  shielding.

  ge prior to application of the test level.

• 2309-11_nu_injectomat_agilia

  Electromagnetic immunity — Table 204Injectomat Agilia is
  intended for use in the electromagnetic environment specified
  below. The user of Injectomat

  Agilia should make sure it is used in such an environment.

  Note 1: At 80 MHz and 8Note 2: these guidelines

  electromagnetic

  (a) Field strengtmobile radiosaccuracy. Tosurvey shoulexceeds
  the operation. If re-locating In

  (b) Over the freq

  Immunity testIEC 60601-1-2

  IEC 60601-2-24Test level

  Compliance level obtained by the

  deviceElectromagnetic environment — guidance

  Conducted RFIEC 61000-4-6

  10 Vrms150 k

  10 Vrms Portable and mobile RF communications equipment should
  be used no

  Radiated RFIEC 61000-4-3

  10 V80 M_INT 33

  00 MHz, the highest frequency range applies.may not apply to all
  situations. Absorption and reflection from structures, objects and
  people affect propagation.

  hs from fixed transmitters, such as base stations for radio
  (cellular/cordless) telephones and land, amateur radio, AM and FM
  radio broadcast and TV broadcast cannot be predicted theoretically
  with access the electromagnetic environment due to the fixed RF
  transmitters, an electromagnetic sited be considered. If the
  measured field strength in the location where Injectomat Agilia is
  usedapplicable RF compliance level above, Injectomat Agilia should
  be observed to verify normal

  abnormal performance is observed, additional measures may be
  necessary, such as re-orienting orjectomat Agilia, or install
  magnetic shielding.uency range 150 kHz to 80 MHz, field strengths
  should be less than 10 V/m.

  Hz to 80 MHz closer to any part of the Injectomat Agilia
  including cables, than the recommended separation distance
  calculated from the equation applicable to the frequency of
  transmitter.

  Recommended separation distance:D = 0.35 P, for a frequency of
  150 kHz to 80 MHzD = 0.35 P, for a frequency of 80 MHz to 800 MHzD
  = 0.7 P, for a frequency of 800 MHz to 2.5 GHz

  Where P is the maximum output power rating of the transmitter in
  Watts (W) according to the transmitter manufacturer and D is the
  recommended separation distance in meter (m).

  /mHz to 2.5 GHz

  10 V/m

  Field strengths from fixed RF transmitters, as determined by an
  electromagnetic site survey (a), should be less than compliance
  level. (b)Interference may occur in the vicinity of equipment
  marked with the following symbol:

• 34

  Recommended separation distances between portable and mobileRF
  communication equipment and Injectomat Agilia — Table 206Injectomat
  Agilia is intended for use in an electromagnetic environment in
  which radiated RF disturbances arecontrolled. The user of
  Injectomat Agilia can help prevent electromagnetic interference by
  maintaining aminimum distance between portable and mobile RF
  communications equipment (transmitters) and InjectomatAgilia as
  recommended below, according to the maximum output power of the
  communication equipment.

  For transmitters rated at(m) can be estimated uspower rating of
  the trans

  Note 1: At 80 MHz and 8Note 2: These guidelines

  electromagnetic

  The use of accesimmunity of the dThe device shoube monitored to
  vcable).

  Rated maximumpower of trans

  (W)

  0.01

  0.1

  1

  10

  1002309-11_nu_injectomat_agilia_INT

  a maximum output power not listed above, the recommended
  separation distance d in metersing the equation applicable to the
  frequency of transmitter, where P is the maximum outputmitter in
  watts (W) according to the transmitter manufacturer.

  00 MHz, the separation distance for the highest frequency range
  applies. may not apply to all situations. Absorption and reflection
  from structures, objects and people affect propagation.

  sories and cables, other than those specified, can result in
  increased emissions or decreased evice.

  ld not be used adjacent to other equipment. However, if adjacent
  use is necessary, the device should erify normal operation in the
  configuration in which it will be used (pump with a mains cable, an
  RS232

  output mitter

  Separation distance according to frequency of transmitter in
  meters (m)

  150 kHz to 80 MHzd = 0.35 P

  80 MHz to 800 MHzd = 0.35 P

  800 MHz to 2.5 GHzd = 0.7 P

  0.04 0.04 0.07

  0.11 0.11 0.22

  0.3 0.3 0.7

  1.1 1.1 2.2

  3.5 3.5 7

• 2309-11_nu_injectomat_agilia

  13.Cleaning and use conditions

  Cleaning and disinfecting Injectomat Agilia is part of the
  patients immediate environment. It is advisable to clean and
  disinfect thedevices external surfaces regularly and especially
  before connecting a new patient and before any maintenanceoperation
  in order to protect patient and staff.

  1. Prepare the detergent-disinfectant solution.2. Disconnect the
  device from the power supply.3. Moisten the dispos

  each stage of the c4. Start by cleaning th

  the mobile parts. P5. Continue the clean6. Clean the keyboar7.
  Complete the clean8. Do not rinse, leave9. Protect and keep t

  10. Validate the mainte Do not place in an A Do not use:
  TRICCHLORINE and AROCETONE. These aggre Take care also withcracks
  in the plastic, anbe used, in accordancethe accumulation of the
  Please contact theestablishment for furth

  EnvironmentaThe device should bedisconnected via the
  btechnician.

  Use of the inteThis device is providedswitches to battery
  moBefore starting for the without using the devicThe maximum life
  of thIn case of frequent mathe device on the batte

  Storage conditionTemperature: — 10C tPressure : 500 hPHumidity :
  10% to _INT 35

  able cloth with the detergent-disinfectant solution, carefully
  wring out the cloth. Repeat at leaning process.e bottom side of the
  device. Then carefully turn the device upside down without touching
  ut down the device on a clean surface.ing on sides of the device
  without wetting the sockets.d.ing of the most exposed surfaces, the
  most critical zones and the mains cord.

  to dry.he device clean before reuse.nance protocol by simple
  bacteriological checking.UTOCLAVE nor IMMERSE the device. Do not
  let liquids enter the devices casing.

  HLOROETHYLENE-DICHLOROETHYLENE — AMMONIA — AMMONIUM CHLORIDE
  -MATIC HYDROCARBON — ETHYLENE DICHLORIDE-METHYLENE CHLORIDE -ssive
  agents could damage the plastic parts and cause device
  malfunction.

  ALCOHOL BASED SPRAYS (20% — 40% alcohol). They lead to
  tarnishing of and smalld do not provide the necessary cleaning
  prior to disinfecting. Disinfecting SPRAYS may with the
  manufacturer recommendation, from a distance of 30 cm of the
  device, avoid product in liquid form. appropriate service,
  responsible for cleaning and disinfecting products, in your

  er details.

  l conditions stored in a dry and cool place. In case of
  prolonged storage, the battery should beattery access flap situated
  underneath the device. This should be done by a qualified

  rnal battery with a NiMH battery. When the device is
  disconnected from the main, it automatically

  de. first time, charge the battery for approx. 5 hours by
  connecting the power supply corde. e battery achieved after several
  charge/discharge cycles.in operations, battery life may be
  decrease. To limit this risk, it is recommended to usery mode,
  approximately every 4 weeks, until getting a PRE-ALARM BATTERY
  signal.

  s and carryingo +60C.a to 1060 hPa.90%, no condensation

  Use conditionsTemperature: 5C to 40C.Pressure : 700 hPa to 1060
  hPa.Humidity : 20% to 90%, no condensation.

  tamnguyenHighlight

• 36

  Recommendations Fresenius Kabi will not be liable for any
  damages or claims, medical or otherwise, of any nature
  whatsoever,whether direct or consequential, caused by improper use
  of this device. Use only 3 parts syringes from the preprogrammed
  syringes type list on the device, otherwise the specifiedaccuracy
  and functioning level can not be guaranteed. Use only sterile
  catheter extensions, which can resistpressures of up to 2000 hPa.
  Use of certified syringes according to international standards
  avoid introduction ofair in the syringe. Use of a syringe not
  corresponding to one selectable on the device means that accuracy
  levelscannot be guaranteed. The use of non-screflow rates and/or
  high pand good medical pracprecaution should be (e.g. syringes,
  extensio While in use, negatthe injection site or by High
  depression maused (possible leakage Pressure variation minfusion
  system charabacklash. Anti-siphon vsyringe with a line not Do not
  use in conjuthan 2 000 hPa suscep Fresenius Kabi repressure
  infusion devic If there is no one winfusion, this will makeand
  could result in accwhich could later be infreleased. Place the
  connectioas near to the start of tspace and consequentline. When
  the device iattention to correctly sethe extension set is cla In
  order to ensure turned ON when connfor a while, use the
  Pa2309-11_nu_injectomat_agilia_INT

  wable extension lines or syringes may result in spillage if
  infusions are carried out at highressure. Connect the infusion line
  in accordance with procedures in your establishmenttices. Fresenius
  Kabi recommends the use of Luer Lok type infusion lines.
  Standard

  taken to prevent contamination or injuries while discarding the
  associated disposablen sets, needles, etc.).

  ive pressure variation may occur in the syringe, by the relative
  height from the device tocombined infusion devices such as blood
  pump, alternative clamp, etc.y create syringe siphoning. In this
  situation, you must check the integrity if the syringe), and if
  necessary insert anti-siphon valves.ay generate flow discontinuity
  mainly noticeable at low flow rates and depending of the

  cteristics such as friction force, stickiness, compliance of
  syringes and mechanicalalves will also eliminate any risk of free
  flow during syringe changes. An air leakage in a

  equipped with an anti-siphon valve may generate an uncontrolled
  flow delivery.nction with positive pressure infusion devices that
  could generate back pressure highertible to damage infusion
  disposable and the device.commends the use of one way valves or
  positivees for multi-line infusions.ay valve on a gravity infusion
  line during a multi-line it impossible to detect occlusions on the
  patient side,umulation of the drug being infused in the gravity
  line,used in an uncontrolled manner when the occlusion is

  n between the feeder line and the syringe-driver linehe catheter
  as possible in order to minimize the deadly the impact of any
  change in flow rate on the feeder

  s placed higher than the injection site, please paycure the
  syringe and manipulate the syringe only whenmped or disconnected
  from patient side.all the safety features, the pump must always
  remainected to the patient. Should the pump not being useduse
  function.

  Anti-reflux valve

  DO NOT USE THIS ASSEMBLY

  PREFERRED INSTALLATION

• 2309-11_nu_injectomat_agilia

  14.Services

  Conditions of guaranteeFresenius Kabi guarantees that this
  product is free from defects in material and workmanship during
  theperiod defined by the accepted sales conditions, except for the
  batteries and the accessories.To benefit from the materials and
  workmanship guarantee from our After-Sales Service or agent
  authorized byFresenius Kabi, the following conditions must be
  respected: The device must have been used according to the
  instructions in this Operators Guide. The device must nohandling.
  The device must no The serial number ( In case of non-respparts and
  labor require When return and reDepartment.

  Quality controUpon the hospital requA regular control
  checTechnical manual. Theby any contract or agre

  Preventive maTo ensure normal perevery 3 years. This incThe
  qualified techniciadropped or if any of maCAUTION: Failure to
  functional failure. Internto the pump or user.

  ServicingFor further informatioCustomer service.If a device is
  returnedcarefully, if possible inFresenius Kabi is no

  At the end of the delectrical and electroncompetent recycling
  o_INT 37

  t have been damaged when in storage, at the time of repair, or
  show signs of improper

  t have been altered or repaired by non-qualified personnel.ID/N)
  must not have been altered, changed, or erased.ect of these
  conditions, Fresenius Kabi will prepare an estimate for repair
  covering thed.pair of a device is necessary, please contact
  Fresenius Kabi Customer or After-Sales

  lest, a control check of the device may be performed every 12
  months.k (not included in the guarantee) consists of various
  inspection operations listed in these control checks must be
  performed by an experienced technician and are not coveredement
  provided by Fresenius Kabi.

  intenanceformance of the device, it is recommended that
  preventive maintenance is performedludes battery replacement and it
  should be performed by a qualified technician.ns in your
  establishment or our After-Sales Service should be informed if the
  device islfunctions occurs. In this case, the device must not be
  used.comply with these maintenance procedures can damage the device
  and lead to aal inspection of the device requires the respect of
  particular procedures to void damages

  n concerning the device servicing or use, please contact our
  After-Sales Service or our

  to our After-Sales Department, it is essential to clean and
  disinfect it, then, pack it very its original packaging, before
  sending it.

  t liable for loss or damage to the device during transport to
  our After-Sales Department.

  evice life, return it to an organization competent in the
  treatment of the ic equipment waste. Remove the battery from the
  device and return it to a rganization.

• 38

  Data racks, accessories and maintenance toolsInjectomat Agilia
  is compatible with the Agilia accessories range.For further
  information, please contact our Commercial Department.

  Data managemen

  Maintenance CD

  Vigilant, the IV M

  Ref.

  Duo Agilia 2 channels accessory for power supply centralisation
  073495

  Y Duo Agilia cable

  DC-DC converter Agili

  Nurse call Agilia

  Link 4 Agilia

  Link 6 Agilia

  Link 8 Agilia

  Link 4 + Agilia

  Link 6 + Agilia

  Link 8 + Agilia

  RS 232 cable for Agilia

  USB cable for Agilia

  Vigilant Ethernet cable

  Vigilant WIFI cable for

  Partner Agilia

  Maintenance kit Agilia

  Vigilant Drug Lib for 2309-11_nu_injectomat_agilia_INT

  t

  & tools

  edication Safety Solution

  2 channels cable for DC/DC power centralisation 073497

  a Cable for transportation (ambulances) 073494

  Nurse call cable (4000 V isolated) 073496

  Rack 4 slots for power centralisation 073480

  Rack 6 slots for power centralisation 073481

  Rack 8 slots for power centralisation 073498

  Rack 4 slots for power centralisation and communication
  capabilities

  073482

  Rack 6 slots for power centralisation and communication
  capabilities

  073483

  Rack 8 slots for power centralisation and communication
  capabilities

  073499

  Communication cable for RS232 connection (4000V isolated)
  073493

  Communication cable for USB connection (4000V isolated)
  073491

  for Agilia Communication cable for Ethernet connection(4000V
  isolated)

  073490

  Agilia Communication cable for WIFI connection (4000V isolated)
  073492

  Maintenance CD 067037

  Maintenance tool box 178950

  Agilia Software for drugs adjustment 073473

• 2309-11_nu_injectomat_agilia

  This user guide may contain inModifications may thus be
  maBecause of the evolution of theapplicable only for the device
  This user guide may not be reregistered trademarks in the n

  Revision date: July 2010_INT 39

  accuracies or typographical errors. de and will be included in
  later editions. standards, lawful texts and material, the
  characteristics indicated by the text and the images of this
  document are

  that it accompanies.produced in whole or in part without the
  written consent of Fresenius Kabi. Injectomat, Vigilant and Agilia
  are ame of Fresenius Kabi in selected countries.

  Fresenius Vial S.A.SLe Grand CheminF-38590
  Brzinswww.fresenius-kabi.com

• 2309

  -11_

  nu_i

  njec

  tom

  at_a

  gilia

  _IN

  T

  Injectomat AgiliaIntroductionIntended usePrecautions to be
  taken

  Description of Injectomat AgiliaOperations for useDisplay and
  symbolsAlarm and safety featuresMenuPermanent menuMenu to be
  selected in option mode

  OptionDrugsIntroductionInfusion mode: Volume/time and limit
  volumeDisplay and symbolsSafety features and warningsService
  OptionsDrug library

  User testPerformancesRates rangeVolume LimitVolume/TimeSyringe
  listAccuracyProgrammable pausePressure managementOcclusion alarm
  response time and Bolus volume at occlusion release

  Technical characteristicsElectrical powersBatteryCommunication
  portInfrared communicationComplianceDimensions — WeightTrumpet
  curves

  Guidance and manufacturers declaration on EMCElectromagnetic
  emissions — Table 201Electromagnetic immunity — Table
  202Electromagnetic immunity — Table 204Recommended separation
  distances between portable and mobile RF communication equipment
  and Injectomat Agilia — Table 206

  Cleaning and use conditionsCleaning and
  disinfectingEnvironmental conditionsUse of the internal
  batteryRecommendations

  ServicesConditions of guaranteeQuality controlPreventive
  maintenanceServicingData racks, accessories and maintenance
  tools

INJECTOMAT MC AGILIA

ИНФУЗИЯ

СКОРОСТЬ ИНФУЗИИ 0.1 — 1200 мл/час в обычном режиме, в зависимости от объема шприца (0.1мл/час шаг).

0,1-9,99 мл/час в микро режиме.

ТОЧНОСТЬ ИНФУЗИИ ± 1% механизм; ± 2 % шприц.

ОБЪЕМ ШПРИЦЕВ 5, 10, 20, 30/35, 50/60 мл.

ТИПЫ ШПРИЦЕВ (ПРОИЗВОДИТЕЛЬ) До 50 типов.

РЕЖИМЫ ИНФУЗИИ • мл/час.

• Доза

Единицы дозировки: ng, μg, mg, cal, kcal, U, kU, mmol, mol, Kmol / kg.

Единицы времени: 24ч / ч / мин.

Разведение: X единиц / мл или X единиц / Y мл.

• Объем или доза / время: 0.1 — 99.9 единиц ; 00 ч 01 — 96 ч 00.

• Предел объема 0.1 — 999.9 мл.

ВВЕДЕННЫЙ ОБЪЕМ/ДОЗА Объем: 0.1 — 999.9 мл.

ПРОМЫВКА 3 режима: обязательный, не обязательный, рекомендованный / скорость:1200 мл/час.

БОЛЮС Ручной болюс: скорость: 50 — 1200 мл/час (50 мл/час шаг).

Программируемый болюс (доза или объем / время): 0.1 — 99.9 единиц / 0.1 — 1200 мл время автоматический

расчет.

ДОЗА ИНДУКЦИИ Доза или объем / время: 0.1 — 99.9 единиц / 00 мин 01 — 59 час 59 автоматический расчет скорости.

ОКОНЧАНИЕ ИНФУЗИИ (О/В &ПО) ПВО 1 и ПВО 2: 0.1 — 5 мл/час регулируемая и сохраняемая, продолжительная инфузия, остановка.

БЫСТРОЕ НАЧАЛО ИНФУЗИИ Как стандарт.

ПАУЗА Программируемая от 1 мин до 24 часов, шаг 1 минута.

ИСТОРИЯ СОБЫТИЙ 1500 последних событий.

ГРАФИЧЕСКАЯ ИСТОРИЯ Объем / доза введенная, давление, скорость..

НОЧНОЙ РЕЖИМ В ночном режиме уменьшается яркость дисплея и зеленых индикаторов. Выключение звука кнопок. Ночной

режим может быть включен непосредственно, либо запрограммирован по времени.

ПРОГРАММИРУЕМЫЕ РЕЖИМЫ Без названия лекарства: инфузия без отображения названия лекарства на дисплее.

Маркировка лекарств: инфузия с отображением названия лекарства.

Vigilant Drug’Lib: режим введения лекарств с дополнительными параметрами.

МАРКИРОВКА ЛЕКАРСТВ Вывод на дисплей одного из 50 лекарств из предустановленного списка.

БИБЛИОТЕКА ЛЕКАРСТВ Программируемая с помощью Vigilant® библиотека лекарств для повышения безопасности инфузии.

До 120 лекарств (зависит от размера комментариев) разделенных на 4 библиотеки.

УПРАВЛЕНИЕ ДАВЛЕНИЕМ

КОНТРОЛЬ ДАВЛЕНИЯ 2 доступных режима: изменяемый (от 50 до 750 мм Hg, 25-50 мм Hg шаг) либо выбор из 3 предустановленных.

ДСД Динамическая Система Давления ДСД – предупреждение об изменениях давления.

Быстрое определение повышения давления, падения давления (отсоединение магистрали, утечка).

МОНИТОРИНГ ДАВЛЕНИЯ Графическое изображение давления в инфузионной линии и выбранного предела давления в виде

пиктограммы.

СИСТЕМА АНТИ-БОЛЮС Снижение болюса после устранения причины окклюзии до 0.2 мл макс.

ТРЕВОГИ/ПРЕТРЕВОГИ/БЕЗОПАСНОСТЬ

СТАТУС Зеленые индикаторы для нормальной работы, оранжевые – претревога и предупреждения, красные – тревога.

Сигналы видны с расстояния 5 м.

Все тревоги разъясняются специальными символами , текстовыми сообщениями и звуковым сигналом.

КОНТРОЛЬ УСТАНОВКИ ШПРИЦА Контроль установки кромки шприца, определение головки поршня, проверка анти-сифонной системы, контроль

фиксации корпуса шприца.

КОНТРОЛЬ ИНФУЗИИ Претревога окклюзии, тревога окклюзии, претревога окончания инфузии, тревога окончания инфузии,

претревога достижения предела объема, тревога достижения предела объема, блок кнопок, жесткие и мягкие

ограничения скорости.

КОНТРОЛЬ НАСОСА Тревога механизма, претревога по заряду батареи, тревога разряженной батареи, время заряда батареи в часах

и минутах для выбранной скорости, не подтвержденные установки, технические тревоги с кодами (авто-тест,

вращение мотора), проверка приводящего механизма, проверка прибора, ошибка коммуникации

СЕРВИС Предупреждение о необходимости планового сервиса.

ТЕХНИЧЕСКИЕ ХАРАКТЕРИСТИКИ

ЗАЩИТА ПОРШНЯ Защита поршня шприца от механических ударов “Push-Guard”.

ЭКРАН Монохромный (голубой) LCD дисплей, размер 66 мм x 33 мм (128 x 64 пикселей).

ПОВОРАЧИВАЕМЫЙ ЗАЖИМ Поворачиваемый зажим, позволяющий крепить насос на стойку либо рельсу /стойка: 20-40мм максимум; рельса:

25-35 x 10 мм.

СОВМЕСТИМОСТЬ Возможность комбинации 3-х насосов между собой без дополнительных приспособлений.

РАЗМЕРЫ (В/Ш/Г)/ВЕС 160 x 345 x 135 мм/2150 г.

БАТАРЕЯ Батарея: NI/MH / Минимальный заряд: 10 часов при скорости 5 мл/час.

Замена батареи: независимый компонент– не требует проведения специфических тестов.

СООТВЕТСТВИЕ СТАНДАРТАМ EN/IEC 60601-1 и EN/IEC 60601-2-24 / CE 0459 маркировано в соответствии EEC 93/42 Европейская Директива по

мед. оборудованию / ЭМС.

ВЛАГОЗАЩИТА IP 22.

ЭЛЕКТРО СОВМЕСТИМОСТЬ Защита от утечки напряжения: CF тип – защита от электрошока: класс II.

ЭЛЕКТРОПИТАНИЕ 100 — 240 Vac / 15 VA, внешний источник 9 Vdc.

Modification: 20 October 2023

Техническая документация (Technical Documentation/Manual) на Инфузомат Pilot A, CE [Fresenius] Разное

Техническая документация (Technical Documentation/Manual) на Инфузомат Pilot C2, CE2 [Fresenius] Разное

Техническая документация (Technical Documentation/Manual) на Инфузомат Pilot Delta [Fresenius] Разное

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