Volumed μVP7000 User Manual Edition 12-07 GA-7000-E

Displays and control elements

GA7000 - E 0807.doc

2

Index numbers Keys: 1 2 3 4 5 6

On/Off Start/Stop Option / Alarm Silence (2 Minutes) Bolus Rate keys Volume keys

Windows: 7 Rate window 8 Volume window 9 Power and running indicators 10 Alarm window 11 LCD information window Mechanical elements relevant for the infusion: 12 Door 13 Door handle 14 Tube guides 15 Stop flow mechanism (here: Robson clamp, the other option is internal) 16 Air detector 17 Pressure Sensor 18 Peristaltic mechanism 19 Easy Clip, empty bag detector Elements of the infusion set: 20 Tubing 21 Drip chamber 22 Robson Clamp Connectors and handling devices: 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

GA7000 - E 0807.doc

3

1 Introduction 1.1 Preamble The Volumed® µVP7000 is a volumetric infusion pump for medical applications. To assure highest standards in quality and user-friendliness latest technology in R&D and production are used. This microprocessor controlled volumetric infusion pump operates by pumping the infusate using a peristaltic mechanism. The sterility of the infusate is not affected. The pump is designed to infuse drugs or other infusates into the patient by controlled means under pressure. The Volumed® µVP7000 can be used in both stationary and transportable applications due to a long battery life span up to 5 hours of duration. Applications include Neonatology, Intensive and Cardiac Care, Paediatrics, Gynaecology and Obstetrics, Surgery and General Medicine. It can also be used in Ambulances and Air rescue. To be informed about technical changes and incidents related to this device, please consult the Arcomed Homepage under www.arcomed.com once a year. The Volumed® µVP7000 may be operated only on mains power installed to DIN VDE 0100-710:2002-11 or the appropriate national standards. The Volumed® µVP7000 meets the Medical Device Directive (MDD) requirements of the EC Guideline 93/42 EEC and is marked CE 0123 (TUV Süd PS Munich, Germany). The manufacturer according to MDD is Arcomed AG, Althardstrasse 150, CH - 8105 Regensdorf, Switzerland. Classification according to MDD: IIb

1.2 General information The Volumed® µVP7000 may only be used by trained staff. Attention should be paid to all security measures and issues as stated in the user manual: -

Warning: The Volumed® µVP7000 infusion pump may only be used for intravenous application of medicine. Using the pump for enteral feeding purposes is not allowed. The correct function of the pump can only be guaranteed if the pump is used with the specified infusions devices. Otherwise, harming of patients, nurses or other people might happen.

-

If the pump shall be operated at very low rates, Arcomed recommends the use of the Syramed® µSP6000 syringe pump.

GA7000 - E 0807.doc

5

-

Warning: The Volumed® µVP7000 must not be used for patients, which are generally contra indicated to intravenous application of medicine.

-

Check the pump and accompanying accessories for damage when unpacking. The pump must not be operated if damaged. Should the pump be damaged contact our Service Department.

-

The correct function of the pump can only be guaranteed if the pump is used 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 should not be installed more than 50 cm above the patient to avoid negative pressure.

-

The Volumed® µVP7000 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, take a bath or similar whilst connected to the pump.

-

Do not operate this pump in an environment with high levels of electromagnetic radiation such as surgical diathermy. Mobile telephones may never be used anywhere near the pump. For additional information also see chapter 9.

-

This pump is not designed for use in areas where there is an explosion hazard. Environmental requirements as per IEC601-1-2 must be observed. For further information contact the official distributor in your country or the Customer Service Department in Switzerland: Arcomed AG, Althardstrasse 150, CH-8105 Regensdorf, Switzerland Tel. +41 (0)43 388 90 30, Fax. +41 (0)43 388 90 40

-

Warning: To avoid a Free Flow situation, always close the roller clamp when changing infusion devices.

-

Every 24 months an annual safety check needs do be done. For further information consult chapter 7

1.3 Cleaning and Disinfections Warning: The pump must be switched off and disconnected from the mains power supply before cleaning and disinfecting. The pump must be kept clean and dry. Remove any spillage immediately. The pump must not be placed in an autoclave. Wipe over with a cloth, which has been damped slightly with an alcohol-based disinfectant, to clean the unit. Take care when cleaning that no liquid enters the inside of the pump case. Wait at least 30 seconds after disinfections before switching GA7000 - E 0807.doc

6

the pump on. Use only disinfectants that are compliant with: ABS, POM, stainless steel, PVC, Aluminium, Silicone (Please check with your supplier of disinfectant).

1.4

Key to symbols

The pictograms and symbols shown on the reverse of the pump have the following meanings or functions: Device of type CF (cardiac float) Caution: consult accompanying documents Nurse Call IPX 1 drip proof Double insulation Infrared interface (RS 232)

1.5 Power and Running indicators (9) The following symbols indicate:

Drop is falling Operation on mains Operation on battery

GA7000 - E 0807.doc

7

2 Specifications Classification Software revision CE certification number Flow rate range Flow rate increments Volume range Volume increments Deviation of flow rate with approved Infusion set (3101 P - PVC) Deviation of flow rate with approved Infusion set (8101 P - Silicone) Over infusion in case of error (electrical or mechanical error) Air detection Sensitivity Keep Open Rate „KVO“ Bolus rate, Prime rate Infusion pressure minimal: Infusion pressure maximal: Alarm pressure limit pressure sensor Resolution pressure sensor Battery operation time (2.15Ah) Charging time Supply voltage External power supply (optional) Input power Mains fuse Type of protection against electric shock Protection against ingress of liquids Leakage current: Radio interference: Nurse call, potential-free Degree of protection against electric shock:

Dimensions Housing: Weight Maximum storage period: Atmospheric pressure Permitted temperature range: Permitted relative humidity: Safety certification

GA7000 - E 0807.doc

IIb 1.xx (Classic), 2.xx (Deluxe) A23 02 04 07000 01 0,1 – 999,9 ml/h 0,1 ml/h 0,1 – 9999,9 ml 0,1 ml typical +/- 5% (PVC tubing) typical +/- 3% (Silicone tubing) max 1,5ml ultrasonic typical 150 µl, adjustable from 50 µl to 250 µl 3 ml/h (adjustable) 999 ml/h (adjustable) 60 kPa / 450 mmHg / 0,6 Bar 120-150 kPa/ 900-1875 mmHg/ 1.2-2.5 bar (depending on set) 0 - 999 mbar (mmHg, adjustable) 10 mbar (mmHg, adjustable) > 3h (up to 5 hours) 15 hours turned off / 20 hours running 230 VAC+10%-15%, 50/60 Hz 12-15V AD/DC 9.3 VA 200 mAT/IEC127/III/SEV 1064 Class II IPX 1, drip proof < 40 µA CE-Class A 24 V/ 0,2 A CF (cardiac floating) (LxHxW) 245x90x180 mm ABS plastic, UL listed ca. 2,6 kg max. 3 months without charging 500-1000 hPa 15°C - 35°C / 0°C- 40°C (operation/storage) 20-90% max. (no vapor deposit) IEC 60601-1 IEC 60601-2-24 IEC 60601-1-2 8

Dispose old pumps according to the national guidelines. Old batteries must be disposed of in an environmentally friendly manner or returned to the manufacturer.

3 Operation 3.1 General remarks The figures in brackets refer to the illustrations of front and rear views shown on pages 2 and 3. Warning: Use only approved infusion sets. The performance of the pump depends on both pump and administration set. The Volumed® µVP7000 must only be used with the sets the pump has been calibrated to. The functional safety of the pump cannot be guaranteed if non-approved infusion sets are used. The safety of the patient may be compromised as a result. Disposable IV sets are for single-use only. Single-use needles carry an infection hazard and must be disposed of in accordance with local guidelines. PVC infusion sets should be replaced every 24 hours, silicon infusion sets after 72 hours. The brand of infusion set the pump is calibrated to is indicated by a sticker on top of the pump.

3.2 Preparing the pump for infusion 3.2.1 Installation Information If the pump is to be operated with an infusion stand, care must be taken that the pump is not positioned more than 1.4m above the ground to ensure stability. Ideally use an "Arco Luxe" or "Arco Standard" infusion stand. If several pumps are mounted one above the other the maximum permitted height from the floor must be observed and measures taken to prevent instability. -

The pump must not be fixed on poles with a diameter of more than 30 mm.

-

The pump may be fixed to the infusion stand by means of the pole clamp (22) on the rear of the unit. The screw must not be tightened by means of tools. Hand tighten the screw only, do not apply an excessive amount of force.

-

Permitted mounting: positioned on a flat horizontal surface or pole mounted on an infusion stand or rail mounted.

-

Where possible mains power should be used. Plug the mains power cable into the connector socket (18) at the rear of the pump. The mains pictogram illuminates as soon as the mains supply is connected. The battery is charged automatically.

GA7000 - E 0807.doc

9

3.2.2 Drug Library The Volumed® µVP7000 CLASSIC and DELUXE have a drug library for 80 drug labels. Pumps fitted with software revisions prior to 2.24 and 1.24 have Drug Library with 20 drug labels. The drug Library is downloaded into the pump via the Infrared Interface Adapter (order number 5305) with aid of software. To receive further information on setting up the pumps drug library, contact your Arcomed dealer. 3.2.3 Retrieving further information when starting up the pump Display of Software Revision: By pressing the „Total 10ml down“ – key while turning on the pump with the ON/OFF - key (1) the pump displays the software revision and the configuration (2.xx, c.xxx) of the pump. After 3 seconds the pump goes into normal mode. Display of the Serial Number: By pressing the „Total 1 ml down“ – key while turning on the pump with the ON/OFF key (1) the pump displays the serial number (P.nr xx.xx xxxx). After 3 seconds the pump goes into normal mode. Display of User Number: By pressing the „Total 0,1 ml down“ – key while turning on the pump with the ON/OFF - key (1) the pump displays the individual user number (nr xxxx). After 3 seconds the pump goes into normal mode. 3.2.4 Inserting the infusion set and choosing the drug from the drug library 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 the roller clamp. -

Insert the infusion set an the appropriate place into the container and fill the drip chamber to one third. Purge the line by slightly opening the roller clamp until the tubing is completely purged.

-

Open the pump door (12) by pulling the latch (13).

-

Pump with internal clamp: Starting with the left side, insert the IV set into the left and right tube guides (14). Ensure that the flow direction of the pump from the left to the right is respected and the tubing is in a straight line. In case of a silicon insert tubing verify the correct position of the silicon insert as shown in the front view of this manual.

-

Pump with Robson Clamp: Position the Robson clamp (22) on the tubing. In case of a silicon insert tubing, position the Robson clamp just left of the silicone segment. Close the Robson clamp. Hold the tubing with your right hand with your thumb positioned on the Robson clamp. Starting with the left side, insert the IV set into the left tube guide (14). Ensure that the flow direction of the pump from the left to the right is respected and the tubing is in a straight line. Put the Robson

GA7000 - E 0807.doc

10

clamp with your thumb into the Stop Flow device (15) and insert the remaining tubing onto the right tube guide (14). -

Slot the drip chamber (21) into the empty container detector (19). Make sure that there are no large ribs or joints in the passage of the empty container detector and that fallen drops are detected by the drop-detector‘s light-barrier.

-

Close the door (12) and push the latch (13) firmly against the pump. Open the tubing roller clamp.

-

Switch the pump on: Press ON/OFF key (1). The audible alarm beeps. The software version number (µVP7000, rx.xx) and the configuration of the pump (µVP7000, c.xxx) light up briefly.

-

Wait until the automatic Stop Flow test is terminated.

-

The Volumed® µVP7000 has the possibility to prime the line with the pump. Press the bolus key (4) until the LCD display (11) shows: “priming?” Press and hold the bolus key until the priming is finished. To terminate the priming mode press the Start/Stop key (2). Important: during priming both air alarm and empty bag alarm are ignored. The prime rate is displayed in the rate window (7). After priming is finished press the Start/Stop key. Warning: Make sure the patient is always disconnected when priming.

-

Now you can connect the infusion set to the patient.

-

If a drug library has been transferred to the pump (chapter 3.2.2) the drug can be chosen by double pressing the Bolus key (4). The LCD (11) displays the actual drug. The Volume window (8) displays „dr.xx“. By pressing the volume keys „0,1 ml up“ and „0,1 ml down“ the drug can be selected. By selecting the drug, also the corresponding soft limits and hard limits are activated. The drug selection can be confirmed by pressing the Option key or the Bolus key.

3.3 Starting the infusion There are three ways to enter the infusion parameters: 3.3.1 Setting rate and volume Use the UP/DOWN keys (5) to select the required rate in ml/h indicated in the RATE ML/H display (7). Use arrow up keys to increase rate, arrow down keys to decrease rate. Note each key press produces single digit change. The least significant digit (smallest size) indicated is 0.1 (units). If a specific volume is to be infused, the required volume in ml may be selected in the VOLUME window (8) using the UP/DOWN keys (6) before starting the pump. Otherwise the infusion can be started by pressing the “Start/Stop” key. Note: To detect a possible malfunction of the display it is necessary to verify that the display changes its values according to the input. GA7000 - E 0807.doc

11

3.3.2 Setting volume over infusion time (automatic rate calculation) If the volume to be infused (VTBI) by the pump and the duration of the infusion are known the pump can calculate the rate automatically, after the infusion set has been inserted and primed properly. When the pump is ready for entering rate and VTBI, press and hold the “Option” key (3) until the RATE ML/H window (7) displays message “h 00.00”. Enter the infusion time in the RATE window and the VTBI in the VOLUME window, observe as data is entered it is simultaneously displayed on the LCD (11). Once all values have been correctly entered, press the “Start/Stop” key (2) to commence infusion 3.3.3 Recall of previous data If a pump is accidentally switched off or there is a loss of power due to depleted battery, infusion data will be lost. Ensure mains power is applied to the pump in case of flat battery. Press & hold the “Start/Stop” key (2) and then press ON/OFF key (1), initially the entire front display will illuminate and pump then performs a display test. Once the test is finished all data from the last infusion will be displayed and the pump can be restarted with the old infusion settings. 3.3.4 Primary and Secondary Infusion The pump gives the user the option for a Primary / Secondary infusion mode. This allows infusion therapies as such the following can be given with 7000 series pump: Flush the infusion set with NaCl or Glucose after a highly potent medication has been given Administer a loading dose of a medication Administer antibiotics to a patient receiving already a primary infusion To switch on the pump in the Primary/ Secondary infusion mode, press and hold the 0.1 ml up key while the pump is powered on. Press the OPTION key to switch from the Secondary to the Primary mode. Procedure: 1. Ensure that on both, the Primary and Secondary set the rollers clamp are closed Attach Easy Clip to Drip chamber of the Primary set. 2. Switch pump on in Primary / Secondary mode - see above 3. Load Primary set in the pump, close door and open roller clamp on the Primary set. 4. Pump will perform self test, once completed, note then the pump will be in Primary infusion mode. 5. Observe the VOLUME window for flashing message “PrI.” simultaneously LCD displaying "Set PRI Rate" message. Enter the desired Primary rate in the RATE window, the Primary volume in the VOLUME window. 6. Press the OPTION key to switch over to Secondary mode. 7. Observe the VOLUME window for flashing message “SEC.” simultaneously the LCD is displaying "Set SEC Rate" message. Enter the desired Secondary rate in the RATE window, the Secondary volume in the VOLUME window. 8. Press the OPTION key to switch over to Primary mode.

GA7000 - E 0807.doc

12

9. Press START key to begin Primary infusion, press STOP key to halt the infusion at anytime. 10. To administrate Secondary infusion, stop the pump. Then press the OPTION key, to switch over to the secondary infusion settings. Ensure that roller clamp is closed on the Primary set and open the roller clamp on Secondary set. Move the Easy Clip from the Primary set drip chamber to Secondary set drip chamber. Press START key to administrate Secondary infusion. 11. If any time primary infusion is required, follow these step: - Halt Secondary infusion, close roller clamp, move the Easy Clip to Primary set - Open roller clamp on Primary set, press OPTION key and start Primary infusion. Note: Switching over from Primary to Secondary infusion and visa versa is only possible when the pump is stopped.

3.4 During infusion 3.4.1 Information of infusion available on the LCD When the pump is running, the green drop symbol flashes (9). The VOLUME display now indicates the volume infused in ml. In order to display various data, such as pump condition, volume to be infused, infusion time, time to end of infusion, battery condition, pressure and pressure limit, press the OPTION key (3) sequentially and observe the LCD window (11) until the required data is displayed. 3.4.2 Dynamic Rate change Note: This feature is not enabled on pump on standard settings. Contact your Technical Depart. or your Arcomed distributor to enable this feature. Rate or VTBI can be changed during an infusion without stopping the pump. Whilst the pump is running, press one of the keys in RATE or VOLUME, this will result both displays to flash. Select the new rate or VTBI and press “Start/Stop” key to accept the change. Observe the pump, it will automatically switch over to the new infusion parameters. 3.4.3 Changing the infusion container and continuing with the infusion When changing the plastic container or bottle, infusion can be interrupted at any time by means of the „Start / Stop“ key (2) without affecting the set or displayed values. In this state, handling operations such as changing the container or IV set and rate changes can be implemented without activating the alarm. In the stop mode, KVO operation is automatically activated (chapter 3.6). If the pump remains in the stop mode for more than 2 minutes, the audible reminder alarm will sound. Warning: Always close the roller clamp before opening the door.

GA7000 - E 0807.doc

13

3.4.4 Resetting the infused volume Note: This function is only accessible when the pump is in stop mode. If pump is running stop the pump pressing the „Start / Stop“ key (2). Ensure the LCD displays the infused volume. Press and hold “Option” key until the VOLUME window begins to flash, observe the LCD displays: “Reset Volume infused ?”. Press the „Start / Stop“ key to reset the infused volume or the “Option” key to abort the function. In cases where resetting the infused volume was not successful, press the “Option” key several times until the infused volume is displayed in the LCD, then repeat the above. 3.4.5 Infusing a Bolus A Manual or an Automatic Bolus can be given when the pump is infusing as described below: Manual Bolus Press and hold the “Option” key (3) and the “Bolus” key (4) together until the desired bolus volume has been given. The Bolus rate is displayed in the RATE window (7) and the bolus volume infused in the VOLUME window (8). Simultaneously the LCD display (11) will show "Bolus Manual". Keep the keys depressed until the required bolus volume has been infused. As soon as the keys are released the pump reverts to the normal infusion mode. Automatic Bolus with default rate Press and hold the “Bolus” key (4) until the display in the VOLUME window (8) flashes. Enter desired bolus volume in the VOLUME keys (6). Press the “Bolus” key to deliver the bolus volume, indicated by the bolus volume infused in the VOLUME display, bolus rate in RATE window and “Bolus Automatic” message in the LCD display. After the delivery of the bolus volume the pump will automatically switch to normal delivery mode. During the bolus function, it can be terminated anytime by pressing STOP key (2). To exit bolus function press the Option key (3). Automatic Bolus with adjustable rate Press and hold the “Bolus” key (4) until the display in the VOLUME window (8) flashes. Enter desired bolus volume in the VOLUME keys (6). Press “Start/Stop” key (2), the RATE display will flash, then enter the desired Bolus rate. Press the “Start/Stop” key again, the delivery of the bolus volume starts. It is indicated by the bolus volume infused in the VOLUME display, the bolus rate in RATE window and the message “Bolus Automatic” in the LCD. Note: Once a bolus volume is given it is added to the total volume infused.

GA7000 - E 0807.doc

14

3.5 Stopping the Infusion The infusion is stopped if one of the following events occurs: -

When the selected VTBI has been infused, the pump will display on the LCD “infusion complete”, further more audible and visual alarms are emitted, pump switches to infuse at KVO rate (keep vein open - see: 3.6).

-

When a user alarms occurs, for example: occlusion, open door, rate change, etc, pump will stop and alarm. Descriptions of user alarms and how to eliminate them are found in chapter 4

-

Whenever the “Start/Stop” key is pressed the infusion is stopped and the pump will infuse at KVO rate.

To switch off the pump, press and hold the “On/Off” key (1) for at least 2 seconds, this is only possible when the pump is in stopped mode. When the “On/Off” key (1) is pressed momentarily the pump will shut down in Standby mode, observe the RATE and VOLUME windows will display a message “Standby”. All the infusion parameters will be held in a stationary condition. Anytime one of the keys in the RATE or VOLUME windows is pressed, this will activate the pump and then by pressing the “Start/Stop” key the infusion is resumed. Note: This function is not enabled on standard settings. Contact your Technical Department or your Arcomed distributor to enable this function.

3.6 Keep – Vein - Open (KVO) – Rate The KVO rate is set at 3 ml/h. Whenever the user stops the infusion, it remain at this rate, as long the rate was set higher for infusion. If the rate is set less than 3 ml/h then KVO rate will be same when infusion is stopped. The KVO rate can be adjusted higher or lower than 3 ml/h or set to zero (no KVO), this can be configured in the service mode. Contact your technical department or your Arcomed distributor to adjust the KVO rate. Note: The KVO is also referred as Keep-Open-Rate (KOR).

3.7 Setting up the Occlusion pressure limit The Volumed® µVP7000 is fitted with a pressure monitoring system. The occlusion pressure limit is set to a default factory setting; this value can be adjusted in the service mode. Contact your Technical Department or your Arcomed distributor to adjust the default pressure Occlusion limit.

GA7000 - E 0807.doc

15

Press the “Option” key (3) twice rapidly to display pressure in LCD and pressure limit in the VOLUME window. Using the up/down keys in the VOLUME ML keys to change the pressure limit. OR Press and hold “Option” key till the VOLUME ML window (8) flashes "L XXXX", Occlusion Pressure Limit. Using the up/down keys in the VOLUME ML window and the Occlusion pressure limit can be changed accordingly. There is the possibility to have a dynamic adjusting of the pressure limit depending on the rate. In this case the pump will decrease the occlusion limit if the rate decreases.

3.8 Setting time and date Time Adjustment Press the OPTION key (3) in sequence till the date and time are displayed in the LCD (11). Press and hold the OPTION key down until the VOLUME ML window (8) flashes the time. Using the keys in the VOLUME ML window, time can be changed. This can also be done while the infusion is in progress. The pump has the intelligence to adjust automatically for summer/ winter time. Caution: If message ‘Clock !’ should appear on LCD, then the Lithium battery needs replacing on the Main PCB. Date Adjustment Switch pump on in Service Mode. Enter value in the RATE ML/H window as shown table below and corresponding data in the VOLUME window. Press the START/STOP key each time to confirm each setting:^ Rate 145 144 143 142

Volume 0 to 99 1 to 12 1 to 31 1 to 7

Function Year Month day weekday (Mo = 1, Su = 7)

Once the changes have been made, press ON/OFF key (1) to switch the pump off. Note: Incorrect setting of date or time do not affect the function of the pump.

3.9 Options for external connections to the pump Accessory equipment connected to the analogue and digital interfaces RS232 interface (IR interface) must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC 601-1-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the GA7000 - E 0807.doc

16

system standard IEC 601-1-1. If in doubt, consult the technical service department or your local representative. To connect Devices to plugs on the back of the pump, please follow the following directions: -

Use cable number 94070 to connect the Nurse call system (26). If an external 12 V – 15A AC/DC power supply is used and is linked to other equipment, ensure that the safety of the system complies with IEC601-1. Please contact the Customer Service Department of ARCOMED AG for details of the RS232 interface (IR interface) and how to link it to external systems. Empty Bag detector “Easy Clip” Nr. 98502 must be used.

3.10 Accessories and consumables Accessories, expendable parts and single-use items may only be used if they comply with the appropriate international standard and national approvals. Infusion sets, filters and extension sets must be CE marked. Warning: Infusion sets, expendable parts and single use items which are not approved by Arcomed must not be used in combination with this infusion device. If there are any new infusion sets to be used in combination with the Volumed® µVP7000 please contact your local Arcomed distributor for further information. Warning: Every pump is adjusted to only one type of infusion set. Only with this type of infusion set the pump achieves the specified precision regarding flow rate and measuring of pressure. The type of infusion set the pump is calibrated to can be seen on a sticker on top of the pump. The Instructions for Use, the mains power supply cable and the empty bag detector are included as standard equipment with the Volumed® µVP7000. For further accessories see also 3.9 .

GA7000 - E 0807.doc

17

3.11 Using the pump in parallel or multiple infusions If additional infusion systems are connected to the patient's vascular system, this may lead to complications e.g. infusion of air, reverse-flow, interruptions due to alarms and inaccurate flow. To prevent such incidents, please observe the recommendations as stipulated in DIN VDE 0753, Part 5 or contact your distributor.

4 The Alarm system 4.1 Alarm indicators (10) All alarms condition are indicated using illuminated pictograms as shown below. Enter rate

Infusion complete

Pump in KVO Mode

Air alarm

Occlusion alarm

Battery empty

Empty Bag

Pump defect

4.2 Alarm causes The electronic 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. The Volumed® µVP7000 will not start: -

If the infusion set is not inserted correctly in the air in line detector and the stop flow mechanism if no rate has been entered, where it is still at 0ml/h. if the door is open,

The pump only switches to KVO rate during infusion accompanied with an audible GA7000 - E 0807.doc

18

alarm when: -

the “Start/Stop” key is pressed, the pump has infused the VTBI set (infusion complete) attempts are made to alter the rate during operation (only if dynamic rate change is disabled)

The pump will halt and alarm immediately during an infusion when: -

the roller clamp is not opened, the infusion bag is empty, the battery capacity is low and therefore does not allow a safe function of the pump on battery, the pressure exceeds the maximum rating, there are air bubbles in the tubing, the door is opened an internal defect is detected the number of falling drops does not correspond to the set rate there is too much liquid in the drip chamber or the drip chamber is not vertically inserted into the drip chamber the vent on the drip chamber is not opened

4.3 Cancelling the alarm condition An acoustic alarm can be suppressed with the “Alarm Silence” key (“Option” key, 3) 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 determine and eliminate the cause of an alarm before restarting the pump.

4.4 Battery alarm The pump may be operated independently of the mains power supply using the internal battery. If the mains power supply fails, the pump switches automatically to battery operation to continue the infusion without interruption. Battery operation is indicated by illumination of the battery symbol (9). Battery capacity permits from 3 up to 12 hours operation (2.15 Ah battery) depending on the infusion rate set. After approximately 3 to 12 hours operation the battery symbol in the alarm display (10) illuminates and an audible alarm activates. Alarms are cancelled automatically as soon as mains power is restored.

GA7000 - E 0807.doc

19

A low battery alert is activated approximately 30 minutes before the battery is depleted. The battery symbol (9) flashes and an audible alarm activate. To silence the audible alarm, press the “Alarm Silence” key (3). The battery symbol continues to flash until the pump is reconnected to the mains. Warning: It is not allowed to use a pump with a defect battery or a battery which does not pass the battery test (point 8 of safety check – chapter 7.1) on a patient. In case of a mains failure the pump might switch off and stop infusing without any alarm or warning. Defect batteries or batteries which do not pass the battery test (point 8 of safety check – chapter 7.1) must be replaced. Warning: 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 µl 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 µl will not cause an air in line alarm. The volume of all detected air bubbles is add up continuously. If more than 1000 µl of air pass the air in line detector within 15 minutes a cumulated air alarm is triggered. This way it can be assured that a large number of small air bubbles (smaller than 150 µl) will not harm a patient. To rectify the air alarm it is necessary to disconnect the patient. Then take the set out of the pump and prime it again.

4.6 Occlusion alarm The Volumed® µVP7000 has automatic pressure monitoring whereby the pressure in the system is measured via the pressure transducer. The alarm pressure limit can be set automatically or manually. The alarm delay depends on a system consisting of infusion line, canula, pressure limit and the rate

Rate

100 mbar

Pressure limit 500 mbar

1 ml/h 20 ml/h 100 ml/h 999 ml/h

8 min 20 sec 5 sec 0.5 sec

45 min 100 sec 25 sec 2.5 sec

1 bar > 60 min 3.5 min 50 sec 6 sec

Once the pressure exceeds beyond the occlusion pressure limit set either to a total or partial occlusion, the pump stops and residual bolus is automatically reduced to virtually zero volume – this is known as Bolus reduction. An audible and visual alarm is activated. GA7000 - E 0807.doc

20

Warning: Check the IV system carefully for the cause of the alarm. Do not restart the pump until the occlusion is released. Keep in mind that not always an occlusion causes the occlusion alarm. Therefore it is necessary to check that the line is not kinked and that it can be moved freely. After the cause of the alarm is removed, the alarm symbol starts flashing and the pump can be restarted again. It is possible to choose between pressure units “mbar” and “mmHg”. 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 possible to detect an occlusion in such systems. Therefore it can be that the patient does not receive medication for a longer period of time.

4.7 Empty Bag Alarm Every Volumed® µVP7000 is equipped with an Empty Bag Detector – the Easy Clip. The Easy Clip is an optical sensor which detects the falling drops in the drip chamber. The Easy Clip only checks and monitors internal functions of the pump. The pump is not controlled by this device. By detecting when the bag is empty it is possible to use infusion sets for more than one infusion. The Empty Bag alarm is triggered if the actual amounts of drops falling does not correspond to the set rate. In this event the pump stops, an audible and visual alarm is emitted. In general the cause of such an alarm is an empty infusion container. In case the infusion container is not empty, please check the following points: -

The roller clamp is open? Is the drip chamber placed in the Easy Clip in a way that the drops can be seen? Is there no condensed water in the drip chamber? Is the Drip chamber vertically? Is the drip chamber not filled more than half? If there is more than one infusion pump in one stack, attention must be paid to make sure the easy clip is placed at the correct drip chamber. Is the vent on the drip chamber opened? Is the Easy Clip plugged in the right plug? (for more info consult page 2)

Note: The Easy Clip is a safety element which drastically improves patient safety. By monitoring the falling drops several test of internal functions can be made. Arcomed recommends to always use the Easy Clip.

GA7000 - E 0807.doc

21