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Arcomed Volumed uVP7000 Premium Скачать руководство пользователя страница 49

48

GA 7000C-E-0313

© 2013 by arcomed ag, Switzerland

5

Risks and Side Effects

The correct function of the pump can only be assured if used with the correct infusion set and
approved accessories. If other than the infusion sets mentioned on a sticker on top of the
pump shall be used, get in contact with your

arcomed

distributor.

Warning: Improper usage can cause the pump to deliver too slow or too fast.
Depending on the medication this can mean harm to the patient.

6

Warranty

arcomed ag

offers a twelve-month warranty with every Volumed® µVP7000 Chroma series

infusion pump, effective from date of delivery.

The warranty covers the installation and replacement of faulty parts if caused by faulty
assembly or materials. The warranty is rendered null and void if persons who have not been
trained and authorized in writing by

arcomed ag

or Arcomedical Infusion Ltd carry out

changes or repairs and if the inspection and maintenance intervals are not observed.

The warranty does not cover faults, which are caused by normal wear, incorrect operation or
inappropriate handling.

The supplier only accepts responsibility for the safety, functional reliability and performance
of the equipment providing that:



Assembly, extension work, resetting, modification or installations are carried out by
personnel authorized by him.



The electrical system at the operating site meets IEC requirements.



The unit is used in accordance with these instructions for use.

If parts are to be exchanged under warranty, it is not absolutely necessary to send in the
pump to

arcomed ag

. Every technician who has received the technical training by

arcomed

ag

may do warranty repairs.

arcomed ag

will send a new part as quickly as possible.

However, it is necessary to send in the defect parts to receive the warranty exchange. If the
defect part is not sent to

arcomed ag

, the part will be invoiced.

The information provided in this manual applies to the currently prevailing situation and is
given in good faith. The manufacturer reserves the right to make modifications in the interest
of technical progress.

arcomed ag

will endeavour to ensure that future improvements and modifications are

compatible with earlier models.

NOTE:

Always state the model, serial number and where applicable the colour of the unit in

question when ordering spares.

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Содержание Volumed uVP7000 Premium

Страница 1: ...Edition 03 2013 ...

Страница 2: ...indow 9 Information window 10 Alarm window 11 LCD 12 Door 13 Door handle 14 Tube guides 15 Stop flow mechanism here Robson clamp the other option is internal 16 Air in line detector 17 Pressure sensor 18 Peristaltic mechanism 19 Easy Clip empty bag detector 20 Tubing 21 Drip chamber 22 Robson clamp 30 Carrying handle see also page 56 4 3 13 13 12 11 8 6 10 9 7 5 2 1 Volumed µVP7000 Chroma Front vi...

Страница 3: ...brary 12 3 3 Starting the Infusion 15 3 3 1 Menu Controlled Selection of Infusion Modes 15 3 3 2 Individual Program Set up of Rate and VTBI 16 3 3 3 Time over Volume Function 16 3 3 4 Choosing a Drug from the Drug Library 17 3 3 5 Rate Calculation Using Drug Concentration and Patient Weight 19 3 3 6 Special Infusion Modes 24 3 3 7 PCA EPCA Mode 24 3 3 8 TCI Modus general information 29 3 4 During ...

Страница 4: ...ors 43 4 2 Alarm Causes 43 4 3 Cancelling the Alarm Condition 44 4 4 Battery Alarm 44 4 5 Air in Line Alarm 45 4 6 Occlusion Alarm 45 4 7 Empty Bag Alarm 46 4 8 Nurse Call System 47 4 9 Internal Alarm 47 5 Risks and Side Effects 48 6 Warranty 48 7 Performance Data 50 7 1 The Significance of Trumpet Graphs in Clinical Practice 50 7 2 Typical Trumpet Curves of the Volumed µVP7000 Chroma 50 8 51 9 Ma...

Страница 5: ...e customer service department of the company arcomed ag 1 1 Abbreviations Relevant abbreviations which are used in this manual and or in the menu of the pump are listed here Abbreviation Text CE Concentration effect CET Concentration effect target CP Concentration plasma CPT Concentration plasma target KOR Keep open rate KVO Keep vein open PCA Patient controlled analgesia PCEA Patient controlled e...

Страница 6: ...n up to 6 hours of duration Applications include Neonatology Intensive and Cardiac Care Paediatrics Gynaecology and Obstetrics Surgery Pain Treatment Anaesthesia and General Medicine It can also be used in Ambulances and Air rescue Warning It is forbidden to use Volumed µVP7000 Chroma for enteral application To be informed about technical changes and incidents related to this device please consult...

Страница 7: ...with the specified infusions devices If you want to use any other infusion lines than specified on top of the pump please get into contact with your arcomed distributor The Volumed µVP7000 Chroma should normally be operated from a mains power supply The internal batteries will automatically operate the pump in the event of a power failure Warning The patient is not allowed to be in a water tub tak...

Страница 8: ...t comes with the disinfection agent to find out about the correct application residence time dilution Contact between the cleaning agent and skin eyes mouth or other body openings must be avoided In such a case the affected parts must be cleaned with a lot of clear water A doctor should be consulted in every case 1 5 Key to Symbols The pictograms and symbols shown on the reverse of the pump have t...

Страница 9: ...ution pressure sensor 10 mbar It is possible to choose between mbar and mmHg Battery operation time 2 15Ah 3h up to 6 hours Charging time turned off running 10 h Supply voltage 110 230 VAC 50 60 Hz External supply optional 12 15 V AC DC Current consumption 80 mA Mains Fuse 500 mAT L IEC127 III SEV 1064 Electrical safety class II double insulation Protection against ingress of liquids and objects I...

Страница 10: ...terval and initial pitch and sound level can be configured to the customers needs Check if the current setting of the audible alarm is appropriated to the environment before connecting the pump to the patient The Volumed pump can be configured to the customers needs please contact the arcomed representative for detailed information on you pumps configuration settings Very important The infusion se...

Страница 11: ...ed with gloves You might notice a very short delay between the press on the screen and the reaction of the pump This is normal and increases the accuracy of the touch screen The touch screen does only support single presses Multi finger gestures are not supported by resistive technology When swiping or pressing over the screen no action will happen until the finger is removed The pump will activat...

Страница 12: ...ns can be accessed with the keys on the panel Icons with the indication I can also be accessed with the key I 8 on the panel Icons with the indication II can also be accessed with the key II 5 on the panel If several selections are available scroll between the selections with the up down keys in the DATA window This mode is indicated by to alternating v and symbols in the DATA window When changing...

Страница 13: ...F key 1 An acoustic alarm is emitted and all displays are illuminated Make sure the acoustic alarm and displays are working otherwise refrain from using the device Make sure the label of the infusion set corresponds to infusion set the pump is calibrated to Make sure the packaging is in good condition so sterility of the infusion set is given Take the infusion set out of the packaging and close th...

Страница 14: ...fallen drops are detected by the drop detector s light barrier Figure 2 Pump with PVC infusion set Figure 3 Pump with silicon infusion set Warning Pumps calibrated to a silicon infusion set may only be used with a infusion set with silicon segment Always insert the silicon segment in such pumps and not the PVC tubing consider picture above The connectors where the silicone is attached to the PVC m...

Страница 15: ...ays the actual SW Version If the audible sound is not emitted or any displays are defective the pumps must not be used If the test was passed the menu can be displayed by pressing the SELECT key Choose the option Prime Bolus by pressing the DATA keys Figure 5 Overview of functions After confirming with SELECT the infusion line can be purged by pressing and holding the II key on the panel Note The ...

Страница 16: ...ared as described earlier the infusion can be started Several ways to enter the infusion parameter are possible 3 3 1 Menu Controlled Selection of Infusion Modes To access to the overview of all menus press MENU and chose either the touch screen to select directly the function of your choice or press the DATA keys as described in chapter 3 1 1 If you use only DATA keys the menu has the following s...

Страница 17: ...in accordance with the input sequence In case that only a certain amount shall be infused the DATA keys can be used to set the desired volume in ml The infusion is started by pressing the START STOP key If the pump is used together with the empty bottle detector Easy Clip the pump can be started without entering a VTBI Is the empty bag detector not installed a target volume VTBI must be entered be...

Страница 18: ...ug Library HINTS The Volumed µVP7000 Chroma has almost unlimited possibilities of configurations As a pump administrator it s highly recommend to KEEP IT SIMPLE Many nurses are still used to simple ml h infusions and before getting into complicated drug schemes make sure the staff is trained to master and most importantly not confuses e g drug dose calculation or TCI with classic ml h infusions Th...

Страница 19: ...oaded Press the DATA keys to scroll to the menu point Drug Classic ml h If the touch screen is enabled you can directly press on the Drug Classic ml h icon without scrolling Figure 11 Menu for selecting the classic drug library By pressing SELECT again the mode is started The saved drugs can be chosen with the DATA keys and are confirmed with the SELECT key The pump can also be set up to have drug...

Страница 20: ... high definition drug Figure 13 High precision mode Rate 6 25 ml h VTBI 3 78ml already infused 0 59ml 3 3 5 Rate Calculation Using Drug Concentration and Patient Weight The automatic rate calculation allows nursing staff to deliver drugs that are applied in dependence of drug concentration and patient weight optional The drugs have to be previously loaded into the pumps drug library To run the pum...

Страница 21: ...th the SELECT key In general it is possible to set the rate independent from the patient weight in mg h g h and units h or depending on the patient weight in mg kg h g kg h IU kg h mg kg min g kg min IU kg min or mmol h It s also possible to set the rate 24h Example 1 Ebrantil Delivered in mg h 1 Choosing the drug Ebrantil by pressing the key SELECT Figure 15 Selecting the Drug Ebrantil from the d...

Страница 22: ... concentration 5 00 mg ml 3 The rate is set in the corresponding unit in the DATA window The rate window displays the calculated rate in ml h Figure 17 Setting the rate 10 0 mg h this corresponds to 2 0 ml h 4 The rate in ml h can always be checked by using the following formula ml mg ion Concentrat h mg Rate h ml Rate 5 The pump is started with the START STOP key ...

Страница 23: ...kg min 1 Choosing the drug Suprarenin by pressing the key SELECT Figure 18 Choosing the drug Suprarenin from the drug library 2 Input of patient weight Figure 19 Entering the patient weight 50 0 kg 3 Input of concentration in the DATA window Figure 20 Entering drug concentration 0 50 mg ml ...

Страница 24: ...g formula 1000 60 min ml mg ion concentrat kg weight patient kg g Rate h ml Rate 7 The pump is started with the START STOP key NOTE When the pump is infusing rate window will display the rate in ml h The LCD displays the rate alternating in the corresponding unit and in ml h Pressing SELECT twice will display additional information about the ongoing infusion in the LCD To change the rate while the...

Страница 25: ...e first pump has finished its infusion The infusion parameters of the two pumps can be independently selected The second pump can be placed either above or below the first pump Synchronisation up down With this function a second pump can be automatically started after the first pump has finished its infusion During the synchronisation process all infusion parameters will be transferred from the fi...

Страница 26: ...word 1001 in the DATA window confirm with SELECT Figure 22 Entering the password for PCA mode 1001 Next the drug concentration is entered confirm with SELECT Figure 23 Entering the drug concentration 1 00 mg ml Now the charging dose can be set confirm with SELECT Figure 24 Entering the charging dose 0 50 mg ...

Страница 27: ...d patient bolus time in seconds Figure 25 Entering the drug charging time 0 00h maximum speed Now the patient bolus dose can be set NOTE Some parameters might be limited for safety reasons E g you might not be able to set the patient bolus dose above 5 mg Contact your pump administrator for information on limits on your drug modes Figure 26 Entering the patient bolus dose 4 00 mg ...

Страница 28: ...me 0 00h maximum speed The lockout time is the time the patient has to wait from one bolus until the next Figure 27a Entering the patient lockout time 0 04h 4 minutes In case a maximum amount of drugs shall not be exceeded during a certain time period such a time period is entered in the next step Figure 28 Entering the time window 0 10 hour 10 min ...

Страница 29: ...stant rate is set Figure 30 Entering the continuous rate 4 0 mg h which equals with the set concentration 4 0 ml h If the constant rate shall only run for a certain time the continuous time can be set Figure 31 Entering the continuous time 15 min When all parameters are entered the infusion giving set can be loaded After that the roller clamp can be opened and the pump can be started by pressing t...

Страница 30: ... site as precisely as possible Warning Using the pump in TCI mode profound knowledge about the different infusion parameters and how they depend on each other are necessary The user must be aware of TCI specific wording such as effect site concentration plasma site concentration and their interactions In case you do not have profound understanding of TCI you must not use the pump in this mode The ...

Страница 31: ...A keys the different drugs can be chosen to confirm the drug mode press SELECT The different infusion parameters are adjusted with the DATA keys NOTE Depending on the configuration of your pump some parameter windows might be skipped to accelerate the setup of your pump In some modes the entries are limted e g the Schnider and Minto models will only allow certain patient weight and height ratios I...

Страница 32: ...ep is to enter the patient weight in kg Figure 34 Entering the patient weight 65 0 kg Next the height of the patient must be entered Figure 35 Entering the height of the patient 170 cm NOTE With the Schnider and Minto protocol this window shows the current BMI and the maximum values permitted for this protocol ...

Страница 33: ...t age 50 years Next step is to enter the gender of the patient Figure 37 Entering the gender of the patient 1 male 2 female Now the target mode must be selected 1 plasma concentration target mode 2 effect site concentration target mode Figure 38 Entering the TCI Target Mode 2 effect site concentration target mode ...

Страница 34: ...can cause a big drop of the patient s blood pressure It is in the responsibility of the nurses to be prepared for taking counter measures The last step is to enter the necessary target concentration in g ml Figure 39 entering the effect site concentration target cet cet 4 00 g ml ce 0 00 g ml Induction volume 59 mg and Induction time 65 Seconds are displayed for verification purposes of the entere...

Страница 35: ... volume 89 4 mg remaining time until syringe is depleted 29 min 48 sec LCD This lower display alters with the patient data weight height age The short cut Awake conc optional allows to change the awake concentration the syringe short cut will show all infusion parameters Besides the functions described in chapter 3 4 and 3 5 the following TCI specific functions are available by pressing ESC Figure...

Страница 36: ...play the time until the patient should wake up more precise until the ce has fallen below the wake up concentration You can also set the TCI target concentration to zero to stop the TCI infusion This has the advantage that the pump will not issue a standby reminder alarm However make sure this is really what you want Crosscheck the displayed rate in the RATE window to see if the pump is infusing o...

Страница 37: ...both displays flashing Select the new rate or VTBI and press START STOP key to accept the change Observe pump will automatically switch over to the new changes NOTE This feature is not enabled on pump on standard settings Contact your Technical Department or your arcomed distributor to enable this feature 3 4 3 Changing the Infusion Bag and Continue the Infusion While the pump is running it is pos...

Страница 38: ...fused volume the pump must not be stopped However the volume can only be reset with the II key on the panel for safety reasons 3 4 5 Infusing a Bolus While the pump is infusing a manual or automatic bolus can be delivered There are several ways to start the bolus Be aware that for safety reasons the bolus can only be started with the II key 3 4 5 1 Manual Bolus Either the Menu icon and Bolus icon ...

Страница 39: ... 5 2 Automatic Bolus You will have also three possibilities to start an automatic bolus using the Touch screen by pressing MENU and Bolus Prime icons or using DATA keys and navigating to the corresponding icon Activate the bolus function by pressing II To go to automatic bolus press I Thereafter the bolus speed is entered in the DATA window and confirmed by pressing SELECT or II Figure 47 Menu for...

Страница 40: ... at any time by pressing the START STOP key After the desired volume is delivered the pump continues with normal operation mode the delivered bolus volume is added to the volume already infused HINT The pump can be configured with a quick access short cut to the bolus function This allows speeding up and decreasing the number of key presses to enter the bolus menu E g if the bolus is configured to...

Страница 41: ...urned off but all programmed infusion settings remain saved By pressing the ON OFF key shortly again the pump will turn back on with all earlier programmed parameters NOTE This function is by default disabled To enable it get in contact with your arcomed distributor If the pump is connected to mains the battery is charged and the battery condition is displayed on the LCD 3 6 Standby Mode Furthermo...

Страница 42: ... SELECT key Figure 52 Window to change occlusion pressure limit 600 mbar actual rate 5 0 ml h The volume display begins flashing To change the pressure limit press the DATA keys manually It is not necessary to confirm the changes Changing the pressure limit can be done while the pump is running or when it is stopped The new pressure limit is valid until a new infusion is started or until it is cha...

Страница 43: ...presentative for further information Empty bag detector Easy Clip Nr 98502 3 10 Accessories and Consumables It is possible to calibrate the Volumed µVP7000 Chroma pump to infusion sets of other brands than arcomed ag With certain IV sets it cannot be excluded that increased repair costs can arise Furthermore the following safety note should be considered Safety note regarding disposable products a...

Страница 44: ...tronic self monitoring system continuously monitors the correct function of the pump and displays system whilst the pump is in operation If a fault condition should occur the infusion stops immediately and the alarm is activated An appropriate alarm symbol red coloured is illuminated continuously accompanied with a continuous audible alarm The nurse call alarm is activated at the same time By pres...

Страница 45: ...Condition An acoustic alarm can be suppressed with the Alarm Silence key SELECT 4 for two minutes before it will reactivate again After rectifying the cause of the alarm or the rate change the alarm condition is cancelled and infusion resumed by pressing the Start Stop key 2 After changing the rate the alarm condition can be cancelled by starting the pump with the Start Stop key Warning Be sure to...

Страница 46: ...arning For safety reasons only batteries supplied by arcomed ag may be used as replacement 4 5 Air in Line Alarm The air in line detector can detect air bubbles of a size of 50 l and bigger Not every air bubble causes an air in line alarm If the pump is operated with default settings air bubbles smaller than 150 l will not cause an air in line alarm The volume of all detected air bubbles is added ...

Страница 47: ...d the pump may be restarted After the cause of the alarm is removed the alarm symbol starts flashing and the pump can be restarted again In general the pumps should not be used to infuse in systems with very high internal pressure for the following reasons If the pump runs with a low rate it takes some time until the pump builds up enough force to overcome the high pressure It is not always possib...

Страница 48: ...20 on the rear of the unit using cable part number 94070 All alarms are transmitted to the nurse call station Warning Even though it is possible to forward the alarm to the external nurse call system the alarms of the pumps have to be observed by the user locally 4 9 Internal Alarm The Volumed µVP7000 continuously monitors the correct functionality of the pump For safety reasons the pump will trig...

Страница 49: ...ppropriate handling The supplier only accepts responsibility for the safety functional reliability and performance of the equipment providing that Assembly extension work resetting modification or installations are carried out by personnel authorized by him The electrical system at the operating site meets IEC requirements The unit is used in accordance with these instructions for use If parts are...

Страница 50: ...49 GA 7000C E 0313 2013 by arcomed ag Switzerland Warning After a pump was returned from arcomed ag the customer must check that all user specific settings are correct ...

Страница 51: ...peutic limits of the drug to be exceeded It has been observed that cardiac stability can be disturbed by excessive fluctuations in pump output over short time periods Fluctuations in pump output depend to a great extent on the rate set and decrease as the rate is increased 7 2 Typical Trumpet Curves of the Volumed µVP7000 Chroma Typical trumpet curves with infusion set Volumed Set Silicone at a Ra...

Страница 52: ... special precautions regarding EMC and needs to be installed according to the EMC information provided in this document Essential performance for Volumed µVP7000 Chroma series are the following infusing a certain volume of a medication at a certain rate Warning Portable and mobile RF communication equipment can affect medical electrical equipment The Volumed µVP7000 Chroma should not be used adjac...

Страница 53: ... that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 610004 4 2...

Страница 54: ...the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 7 MHz b The compliance levels i...

Страница 55: ...er in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 7 MHz NOTE 3 An additional factor of 10 3 is used in calculating the reco...

Страница 56: ...0 ml h volume to 10 ml Start the pump and check volume with a scale or similar device The cumulated volume must be between 9 7 and 10 3 ml V 5 Test run Rate 100 ml h 30 min PVC set precision max 5 Silicon set precision max 3 ok 6 Occlusion test Insert filled set into the pump and start it with a rate of 100 ml h Kinking the tube on the patient side simulates an occlusion After a short while the oc...

Страница 57: ...r batteries than the ones supplied by arcomed ag are used safe operation of the pump cannot be guaranteed Old batteries must be disposed in accordance with national laws arcomed article number of the battery is 71160 9 2 Repairs The Volumed µVP7000 Chroma infusion pump may only be serviced or repaired by employees of arcomed ag or by people that were trained by arcomed employees Please contact you...

Страница 58: ...Switzerland Displays and Control Elements Index Numbers 23 Mains supply socket 24 Fuse 25 IR Interface 26 Nurse Call Connector 27 Connector for Easy Clip 28 Optional external Power Supply 12 to 15 Volt AC DC 29 Pole Clamp 30 Carrying handle ...

Страница 59: ...58 GA 7000C E 0313 2013 by arcomed ag Switzerland A Adapter for PVC Infusion Set B StopFlow housing C Silicon Infusion Set D Intern Adapter E Robson Adapter C H R O M A C H R O M A ...

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