Arcomed Volumed uVP-7000 Maintenance manual

Maintenance Manual

Volumed® µVP7000

Swiss Made

O N	RATE ML/H		VOLUME ML	2 MIN	START
				BOLUS
OFF				OPTION	STOP
				volumed
				µVP7000
RATE	KVO	INF	DEFECT
		COMPL

ARCOMED AG

8105 Regensdorf / Zürich (an ISO 9001 company)

Important

This manual is exclusively intended for authorized personnel who have been instructed by Arcomed AG in the maintenance and repair of the Infusion Pump indicated above.

Arcomed AG shall assume no liability for tampering by unauthorized persons.

Caution: The manufacturer reserves the right to improve the specifications of this product without prior notice.

Edition 02/03 -VA-TM-7000-E

	Contents
		Page
	Index numbers	0
1.	Introduction	1
1.2.2	Service Intervals	2
2.	Specifications	3
3.	Operation	4
3.18	Parallel / Multiple Infusions	10
4.	Alarm Supervision System	11
5.	Warranty	13
	Design Changes	13
6.	Inspection and Maintenance Intervals	14
7.	Significance of Trumpet Curves	15
8.	Technical description	17
9.	Trouble shooting	21
10.	Replacement of parts	22
11.	Spare parts list 7000	23
Annex A	Drawings
Annex B	Schematics
Annex C	Component layout

Index Numbers

1Administration set

2Drip chamber

3Stop flow clamp (internal or robson clamp)

4Empty container detector (ECD)

5Door

6Door latch

7On / OFF key

8Rate display

9Volume display

10Start / Stop key

11Tube guides

12Pumping-peristaltic

13Occlusion detector

14Stop flow device

15Air detector

16Rate keys

17Volume keys

18Option key, Alarm tone-mute key

19Prime / Bolus key

20Alphanumeric LCD display

21Alarm window

22Information window

23Mains supply socket

24Fuses

25Connector nurse call

26Connector empty container detector (ECD)

27External power supply (12 DC)

28Infra red interface

29Pole clamp

30Carrying handle

4	11
	12	7	11	14	3
2	1
					15
					11

6	5							6
				30
			8		9	18	19	10
	7	16		13
6	ON	RATE ML/H		VOLUME ML		2 MIN		START
							BOLUS
	OFF					OPTION		STOP
						volumed
22						µVP7000
								ag
	RATE	KVO	COMPL		DEFECT			arcomed
			INF
								20
	21			Volumed µVP7000
				Front view

29

30

25

23

24

25

26

27

28

Volumed µVP7000

Rear view

1.Introduction

1.0Introduction

The Volumed® µVP7000 Volumetric Infusion Pump has been developed using the latest state-of-the-art technology. This microprocessor-controlled volumetric pump operates by pumping the infusate using a peristaltic system. 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 meets the performance requirements of the MDA (UK) for neonatal and high risk infusions. It can be used in both stationary and transportable applications as it has a battery life up to 6 hours duration. Applications include neonatology, intensive and cardiac care, paediatrics, gynaecology and osbstetrics, surgery and general medicine. It can also be used in ambulances or for laboratory use. For infusions with very small rates and small volumes it is recommended to use a syringe pump such as the Syramed® µSP6000 as the the remaining volume in the administration set can become significant compared to the infused volume.

The Volumed µVP7000 meets the Medical Device Directive (MDD) requirements of the EC Guideline 93/42 EEC and is marked CE.

Classification: Class IIb

The manufacturer according to MDD is Arcomed AG, Althardstrasse 146, CH 8105 Regensdorf, Zurich, Switzerland. Responsible for the EC is Arcomedical Infusion Ltd., West Horndon, Essex CM13 3XS, UK.

The Volumed µVP7000 may be operated only on mains power installed to DIN 57107 VDE 0107 or the appropriate national standards. If the integrity of the mains power supply protective earth system is in doubt, the pump should be operated on battery power. Mobile telephones should not be used anywhere near this equipment.

1.1Mounting the pump

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.

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

The pump should normally be operated from a mains power supply. The internal batteries will automatically operate the pump in the event of a power failure.

CAUTION: 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. Do not operate this pump in an environment with high levels of electromagnetic radiation such as surgical diathermy or mobile telephones. For further information contact the official distributor in your country or the Customer Service Department in Switzerland:

Switzerland: a r c o m e d a g, Althardstr. 146, CH-8105 Regensdorf Tel. [phone]’47’40, Fax. [phone]’06’49

United Kingdom: Arcomedical Infusion Ltd., 5g West Horndon Industrial Estate, West Horndon, Essex CM13 3X

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Tel. [phone]’81’04’32 Fax. [phone]’81’19’67

The technical manual and the list of spares and used materials can be requested from Arcomed.

1.2.1 Cleaning and disinfection

CAUTION: 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.

The unit is disinfected by wiping over with a cloth which has been damped slightly with an alcohol-based disinfectant. Take care when cleaning that no liquid enters the inside of the pump case. Wait at least 30 seconds after disinfecting before switching the pump on. Use only disinfectant that are compliant with:

- ABS, POM, stainless steel, PVC, aluminum, silicone

Please check with your supplier of disinfectant.

1.2.2 Annual safety check

Battery power is provided by a nickel metal hydride (NiMH) battery which must be checked annually. Battery condition is checked by connecting the pump to the mains power supply for 15 hours in a switched off condition so that the battery may be fully charged. Disconnect the mains power supply and switch the pump on using battery power. Determine the operating time when the low battery alarm activates. This should be at least 3 hours - if not the battery must be replaced. Repeated charging and discharging may in certain circumstances cause degeneration of the battery (memory effect).

Used batteries must be disposed of in an environmentally friendly manner or returned to the manufacturer.

Safety checks (see chapter 6) may be performed only by qualified staff.

1.3.Key to symbols

The pictograms and symbols shown on the reverse of the pump have the following meanings or functions:

Nurse Call

Empty bag detector	!

IPX 1

12 VDC External 12 VDC supply

IR	Interface RS232
	(Infrared Interface)

CF (cardiac floating) part

CAUTION: consult accompanying documents

Drip-proof

class II double insulated

Page 2

2.Specifications

CE Mark

Classification

Software revision

Flow rate range (ml/h)

Volume range (ml)

Deviation in flow-rate with 8101P series administration set Deviation in flow-rate with 3101P series administration set

Overinfusion in case of electrical or mechanical defect

Keep vein open rate (KVO) Bolus rate, Prime rate Infusion pressure min. Infusion pressure max.

Alarm pressure limit

Bolus volume after occlusion

Time to alarm after occlusion

Air detection

Sensitivity

Battery operation time (1.85Ah) 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 contact switch

Degree of protection against electric shock Dimensions

Housing

Weight

A23 02 04 07000 01 IIb

1.xx

0.1 - 999.0 ml/h, increments: 0.1 ml/h

0.1 - 9999.9 ml, increments: 0.1 ml

typ. +/- 3% (Silicone insert)

typ. +/- 5% (PVC line)

1.5 ml max.

3.0 ml/h, adjustable

1000 ml/h, adjustable

60 kPa / 450 mmHg / 0.6 bar

120-250 kPa / 900-1875 mmHg

1.5-2.5 bar (according to IV set)

0 - 999 mbar/mmHg

Automatic bolus reduction (see also 3.9) Depending on rate, pressure limit setting and set, see also table below.

ultrasonic

typ. 100 µl, adjustable from 50 to 250 µl Cumulated 15 min adjustable from 500 to 5000 µl

3 - 5 hrs (dependent on rate and mode)

15 hours/20 hours

230 VAC+10%-15%, 50/60 Hz

12 VDC

9.3 VA

T200 mA/IEC127/III/SEV 1064

Class II

IPX 1, drip proof < 40µA CE-Class A 24V/0.2A

CF (cardiac floating) 245x90x180 mm (WxHxD) ABS plastic, UL listed

2.6 kg (approx.)

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Max. storage period	3 months without charging
Permitted temperature range	15°C - 35°C / 0°C- 40°C
(operation/storage)
Permitted relative humidity	20-90% max. (no vapor deposit)
Atmospheric pressure	500-1000 hPa
Safety certification	DIN IEC 601 Part 1
	EN55011 Radio interference
	IEC60601-1-2 Susceptibility
	IEC60601-2-24
Operating modes	Continual, manual bolus, automatic bolus, priming.
Labeling of the pump	12 alpha numeric caracters.
	Configured through IR interface.
History	Up to 1500 data logs with real time stamps.
	Read out and printout through IR interface and PC.

Time to alarm after occlusion (PVC set), volume of bolus without bolus reduction:

Pressure
Rate	1.0 bar	500 mbar	100 mbar
1 ml/h	>60 min	45 min	8 min
20 ml/h	3.5 min	100 sec	20 sec
100 ml/h	50 sec	25 sec	5 sec
999 ml/h	6 sec	2.5 sec	0.5 sec
Bolus	0.9 ml	0.45 ml	0.09 ml

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3.Operation

The figures in brackets refer to the illustrations of front and rear views shown in the appendices.

CAUTION: Use only approved disposable adiministration sets! (cf. leaflet "Accessories and Consumables")

The performance of the pump depends on both pump and administration set. The volumed 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 IV 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. The IV-set should be replaced every 24 hours.

3.1.Preparation and loading of the administration set

a)If the pump is to be operated on 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 may be fixed to the infusion stand by means of the pole clamp (29) on the rear of the unit.

b) Slot the drip chamber (2) into the empty container detector (4). 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.

c)Carefully purge the infusion set (1), without allowing any air bubbles to enter, until the drip chamber (2) is 1/4 to 1/3 full. If air has entered, repeat purge-procedure.

d)Close the tubing roller clamp.

e)Open the pump door (5) by pulling the latch (6).

f)Pump with Robson Clamp:

Position the Robson clamp (3) 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 (11). 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 clamp with your thumb into the Stop Flow device (14) and insert the remaining tubing onto the right tube guide (11).

Pump with internal clamp:

Starting with the left side, insert the IV set into the left and right tube guides (11). 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.

g)Close the door (5) and push the latch (6) firmly against the pump. Open the tubing roller clamp.

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h) Switch the pump on: Press ON/OFF key ( ) (10). The audible alarm beeps once together with the indication < ! > in the alarm window (21). 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.

i)Check if there is no free flow. 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.

j)The Volumed µVP7000 has the possibility to prime the line with the pump. Make sure the patient is always disconnected when priming:

Press the bolus key (19) until the LCD display (20) shows: priming? Press and hold the bolus key until the priming is finished. To terminate the piming mode press the Start/Stop key (10). Important: during priming both air alarm and empty bag alarm are ignored. The prime rate is displayed in the rate window

(8).

k)Connect set to the patient.

Important: Before the door is opened, close the roller clamp!

3.2.Setting rate (ml/h) and volume (ml)

Use the UP/DOWN keys (16) to select the required rate in ml/h indicated in the RATE display (8). Arrow up keys provide rate increase, arrow down keys provide rate decrease. Check that each key stroke changes one digit. The least significant digit (small size) indicates 0.1 (units).

If a specific volume (VTBI) is to be infused, the required volume in mls may be selected in the VOLUME window (10) using the UP/DOWN keys (13) before starting the pump (optional). Once the VTBI is reached, the pump gives and audible alarm and displays <INF COMPL> (infusion complete) in the Alarm window (21). The pump switches to the KVO rate.

Remark: With the empty bag detector (4) the pump stops automatically after the last drop in the bag. If no empty bag detector is used, the volume (VTBI) has to be set to stop before the bag is completely emptied. Otherwise the pump the pump continues infusing until air is detected in the air detector (18). Hence, it is strongly recommended to use the empty bag detector.

3.3.Pump running

When the pump is running, the green drop symbol flashes (22). The VOLUME display now indicates the volume infused in mls. 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 (18) sequentially and observe the LCD window (20) until the required data is displayed.

If a specific volume to be infused was selected the pump automatically switches to KVO operation when this volume has been infused and an audible and visual alarm (21) activates.

Press the ALARM SILENCE key (5) to silence the audible alarm for 2 minutes.

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3.4.Resetting the volume infused

In order to reset the volume infused, stop the pump by pressing the STOP key (10). Press the OPTION key (18) for 2 seconds until the VOLUME display (9) flashes. When the LCD window (20) displays "000", confirm this by pressing the START/STOP key (10) to reset the volume infused to zero. If it is not desired to reset the volume infused, press the OPTION key (18) until the normal display appears.

3.5.Infusing a bolus

When the pump is infusing, a manual or an automatic bolus can be given.

To infuse a manual bolus:

Press the OPTION key (18) and the BOLUS key (19) together.

The bolus rate is displayed in the RATE window (8) and the bolus volume infused is displayed in the VOLUME window (9). The LCD window (20) indicates "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.

To infuse an automatic bolus:

Press the Bolus key (19) for 2 seconds until the display in the VOLUME window

(9) flashes. The desired bolus volume in mls can then be preset in the VOLUME display using the VOLUME keys (13). Press the BOLUS key (19) to deliver the bolus automatically. If no bolus is required, press the OPTION key (18) to cancel.

During automatic bolus delivery, the RATE display (8) indicates the bolus rate and the VOLUME display (9) indicates the bolus volume infused. The LCD window (20) indicates "Bolus automatic".

To stop the pump at any time press the STOP key (10).

After the selected bolus volume has been delivered, the pump switches automatically to normal delivery mode.

Following bolus infusion, the bolus volume is added to the total ml infused.

3.6.IV container exchange

When changing the plastic container or bottle, infusion can be interrupted at any time by means of the 'Start/Stop' key (18) 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.

If the pump remains in the stop mode for more than 4 minutes, the audible reminder alarm will sound.

3.7.Recall of previous data

If the pump has been accidentally switched off, data such as rate, volume to be infused and volume infused may be recalled during start up. Press the START/STOP key (10) and the ON/OFF key (7) together to recall all data.

3.8.Setting volume and time

If a specific volume is to be infused in a given time the RATE display must be left at zero. After inserting the IV set, closing the door and finishing the automatic test press and hold the OPTION key (18) until the RATE and VOLUME displays flash.

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The time in hours and minutes may be selected in the RATE display (9) and the volume selected in the VOLUME display (9). The pump automatically calculates the infusion rate. Check this carefully in the LCD window (20) before starting the infusion.

3.9.Pressure system

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.

Automatic setting:

If the pump is configured for this mode, the alarm pressure limit is automatically matched to the set rate, the lower the rate, the lower the alarm pressure limit. The time to alarm can be viewed in the table of section 2.

Manual setting:

Press the OPTION key (18) sequentially to display pressure and alarm pressure limit in the LCD window (20). Hold down the OPTION key (18) until the VOLUME display (9) flashes "Lxxx". The pressure limit may be manually set using the VOLUME keys (17) in the VOLUME display (9) and the data in the LCD window changes accordingly. This can also be done while the infusion is in progress. NOTE: Manual setting of pressure deactivates the automatic pressure setting, i.e. the pressure remains at the current level independent of the rate selected.

If the pressure rises beyond the limit set, the pump stops and the stored bolus is automatically reduced to virtually zero volume. An audible and visual alarm is activated. Check the IV carefully for the cause of the alarm. Do not restart the pump until the occlusion is released.

3.10. Setting time and date

Press the OPTION key (18) sequentially to display date and time in the LCD window (20). Hold the OPTION key (18) down until the display flashes. The time may be set using the volume keys (17) in the Volume display (9), e.g. h9.45 = 9:45 am. This can also be done while the infusion is in progress.

The Volumed has the possibility to automatically adjust the daylight save time (summer time). The adjustments can be done as per EU, US or Australian regulations. If the text ‘Clock !’ should appear, replace the Lithium backup battery on the main PCB.

To set the date, first switch the pump off. Press the VOLUME 0.1 ml DOWN and VOLUME 100 ml DOWN keys (17) together whilst switching the pump on. This enables the Service Mode. Select the RATE display (8) according to the following table using the RATE keys (16). Then select the corresponding data in the VOLUME display (9) using the VOLUME keys (17). Press the START key (10) each time to confirm each setting:

Rate	Volume	Function
display (9)	display (10)
145	0 - 99	Year
144	1 - 12	Month
143	1 - 31	Date
142	1 - 7	Weekday (Monday = 1, Sunday = 7)

Press the ON/OFF key (7) to switch the pump off.

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Note: Incorrect setting of date or time does not affect the correct functioning of the pump.

3.11. Different configurations

If a different configuration is required, please contact our Customer Service Department or the official ARCOMED distributor in your country.

3.12. 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. Sets, filters and extension sets must be CE marked. The ordering numbers can be found on the leaflet "Accessories and Consumables"

The Instructions for Use, the mains power supply cable and the empty bag detector (optional) are included as standard equipment with the Volumed µVP7000. For accessories see also 3.19.

3.13. START/STOP key (10)

The START/STOP key (10) is used to start the pump after the rate has been selected. The pump may be stopped at any time using this key. An additional function of this key is to confirm various parameters.

3.14. Prime / Bolus key (19)

The PRIME/BOLUS key (19) key is used to prime the extension set. It is also used to initiate a manual or automatic bolus (3.5).

3.15. AUDIBLE ALARM SILENCE/ OPTION key (18)

The audible alarm may be silenced for 2 minutes using the ALARM SILENCE/OPTION key (18). The audible alarm is re-activated after this period.

If there is no audible alarm, the key serves as an OPTION key which enables selection of any option.

3.16. ON/OFF key (7)

The pump may be switched off using the ON/OFF key (7) if the infusion has been completed. All data displayed (rate and volume) is lost when the pump is switched off. In order to avoid switching the pump off accidentally, the ON/OFF key (7) must be pressed for at least one second before the pump switches off.

If the pump is connected to the mains, the STANDBY mode will switch in when the pump is switched off. This means that the battery will be charged and the charge condition indicated in the LCD window.

3.17. Keep-Vein-Open (KVO) - Rate

The pump may be configured to infuse at the keep vein open rate when the volume to be infused has been delivered. The KVO rate is preset at 3.0 ml/h and may be set (by a technician) to suite individual requirements if necessary. If the set rate is smaller than than the KVO rate, this rate becomes the KVO rate.

Remark: The latest standard uses the new wording Keep-Open-Rate (KOR). The meaning is identical to the KVO-rate.

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