Arcomed Syramed uSP-6000 Maintenance manual

Maintenance Manual

syramed

syringe pump

Swiss Made

ARCOMED AG

8105 Regensdorf / Zürich

an ISO 9001 company

®

µSP6000

0123

CAUTION: This manual is exclusively intended for authorised personnel who

have been instructed by ARCOMED AG in the use, maintenance and repair of

the infusion pump indicated above.

ARCOMED AG shall assume no liability for tampering by unauthorised

persons.

Note: No amendment service is provided for this manual.

Edition 43/03 -VA-TM-6000-E

16

RATE ML/H

9

17

12

ON

OFF

13

10

4

1

2

8

7

syramed

µSP6000

14

5

START

2 MIN

DEFECT

RATE

KVO

STOP

OPTION

ALARM

PRIME

BOLUS

6

15

arcomed ag

3

11

VOLUME ML

syramed 6000

Front view

22

16

18

20 21

19

syramed µSP6000

Rear View

Index numbers

1 Door latch
2 Syringe clamp
3 Drive head
4 Syringe
5 ALARM SILENCE/OPTION key
6 LCD window for messages and infusion parameters
7 START/STOP key
8 PRIME/BOLUS key
9 RATE display
10 VOLUME display
11 ON/OFF key
12 RATE keys
13 VOLUME keys
14 Alarm indicators
15 Door
16 Carrying handle
17 Power and running indicators
18 Mains power connector
19 Mains fuse
20 Nurse call connector
21 IR interface
22 Pole clamp

CONTENTS

Page

1 Introduction 1

1.1 Mounting the pump 1

1.2.1 Cleaning and disinfection 2

1.2.2 Annual safety check 2

1.3 Key to symbols 2
2 Specifications 3

3 Operation 4 - 9

3.18. Using the pump in parallel or
multiple infusions 9

4 Alarm system 10 - 12

5.1 Warranty 12

5.2 Design changes 12
6 Saftey checks 13
7 Performance data 13
8 Technical description 16
9 Trouble shooting 19
10 Replacement of parts 20
11 List of spare parts 21

Annex A Drawings
Annex B Schematics
Annex C Component layouts

1. Introduction

1.0 Introduction

The Syramed µSP6000 is a syringe pump using the latest technology. This
microprocessor-controlled syringe pump operates by pumping the infusate in the
syringe using a controlled single action pumping stroke. 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 Syramed µSP6000 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 long battery life up to 12 hours duration.
Applications include neonatology, intensive and cardiac care, paediatrics,
gynaecology and osbstetrics, surgery and general medicine. It can also be used
in ambulances and air rescue. It is not recommended for blood infusion (unless
the dose requirement is small) due to the limitations in syringe size accoodated
(50/60ml maximum).

The Syramed µSP6000 meets the Medical Device Directive (MDD) requirements
of the EC Guideline 93/42 EEC and is marked CE 0123 (TUV PS Munich,
Germany).

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 3XL, UK.

The Syramed µSP6000 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.

1.1 Mounting 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. ++41 (0)43 388 90 30, Fax. ++41 (0)43 388 90 40

United Kingdom: Arcomedical Infusion Ltd., 5j West Horndon Industrial

Estate, West Horndon, Essex CM13 3XL, UK

Tel. ++44 (1) 277’81’04’32 Fax. ++44 (1) 277’81’19’67

Page 1

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 steal, 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:

IR

!

Nurse call

Interface RS232
(Infrared)

CF (cardiac floating) part

CAUTION: consult accompanying

documents

IPX 1

Drip-proof

class II double insulated

Page 2

2. Specifications

CE Marking No. G5 01 08 13006 010
Classification IIb
Software revision 1.xx
Flow rate range (ml/h) 0.1 - 500 (750 max)
Flow rate increments (ml/h) 0.1
Volume range (ml) 0.1 - 999.9
Volume increments (ml) 0.1
Syringe size (ml) 5, 10, 20, 30, 50/60

(Automatic size recognition)

Syringe brands B Braun, Fresenius, BD, Monoject,

Terumo, Codan, other brands on request
Syringe nearly empty alarm 3 mins (adjustable)
Bolus volume after occlusion Automatic bolus reduction (see also 3.9)
Overinfusion in case of electrical 1.5 ml max.
or mechanical defect
Keep vein open rate (KVO) 0.3 ml/h, adjustable
Bolus rate, Prime rate 1500 ml/h (50/60 ml syringe), adjustable
Alarm pressure limit 0 - 999 mbar/mmHg
Battery operation time (1.85Ah) 3 - 12 hours (dependent on rate set)
Charging time 15 hours/20 hours
Supply voltage 230 VAC+10%-15%, 50/60 Hz
External power supply (optional) 12-15V AD/DC
Input power 8.5 VA
Mains fuse T200 mA
Type of protection against electric shock Class II
Protection against ingress of liquids IPX 1, drip proof
Leakage current < 40µA
Radio interference CE-Class A
Nurse call, potential-free 24V/0.2A
contact switch
Degree of protection against electric shock CF (cardiac floating)
Dimensions 245x90x180 mm (WxHxD)
Housing ABS plastic, UL listed
Weight 2.3 kg (approx.)
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)
Safety certification DIN IEC 601 Part 1

EN55011 Radio interference

IEC601-1-2 Susceptibility

IEC601-2-24

Page 3

3. Operation

The figures in brackets refer to the illustrations of front and rear views shown in
the appendices.
CAUTION: Use only approved disposable syringes!
(cf. leaflet "Accessories and Consumables")

The pump may be configured for one or several brands of disposable syringe:

B. Braun, Fresenius, Becton Dickinson, Monoject, Terumo.

Permitted syringe sizes:
5, 10, 20, 30 and 50/60 ml. The size is identified automatically by the pump.

The functional safety of the pump cannot be guaranteed if non-approved
syringes are used. The safety of the patient may be compromised as a result.

Disposable syringes are for single-use only. Single-use needles carry an
infection hazard and must be disposed of in accordance with local guidelines.
Remark: To avoid air infusion, air filters can be used as there is no obligation to
have an air in line detector on syringe pumps.

Important:

- The patient must be disconnected during the loading and the removal or
change of the syringe.

- The user must check that the pump and drive is not damaged and that the
syringe plunger latch is in its home position before loading the syringe. In case of
damage the syramed must not be used.

- The syramed must not be placed more than 50 cm above the patient and
negative pressures must be avoided.

- In case of multiple or parallel infusions high pressures or negative pressures
can influence the accuracy of the rate (see also 3.18). In the case of strong
negative pressure siphoning can occur and the plunger can be pulled with
considerable forces. It is important to know that these forces can also pull the
plunger after the syringe latch is opened and the pump is not in control of the
syringe.

3.1. Preparation and loading of syringe

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.

b) The pump may be fixed to the infusion stand by means of the pole clamp (22)

on the rear of the unit.

c) 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.

d) Draw up the infusate into the syringe using an aseptic technique and make

sure there is sufficient excess volume to prime the extension set. Connect the

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extension set.

e) Press the ON/OFF key (11). The audible alarm beeps and all indicators

illuminate. The software revision number (rx.xx) and then the pump
configuration (C.xxx) illuminate briefly.

f) Open the pump door (15) by releasing the latch (1). Open the syringe clamp

(2). The drive head (3) is powered automatically to extend fully to the right.

g) Locate the syringe (4) in the pump with the Luer connector to the left so that

the ears of the syringe are positioned in the slot in the pump body. THIS IS
IMPORTANT. Push the syringe ears to the left so that they engage the front
edge of the slot.

Controlled automatic syringe loading:

After closing the syringe clamp (2) the drive head stays extended to the right.
Press the PRIME key (8) and hold it down so that the drive head is powered to
engage the syringe and to lock onto the syringe plunger. When the infusion is
finished press the PRIME key (8) to move the drive head to the parking
position.

CAUTION

During the loading process, the user must check that infusion lines electrode
leads or any other obstructions do not get caught up in the drive system and
that the syringe plunger latch is in its correct home position to allow a correct
syringe loading. Check that the plunger is correctly secured after loading.

h) The LCD window (6) indicates the brand and size of syringe. Press the

START/STOP key (7) to confirm this. If the pump is configured for several
syringe brands, the OPTION key (5) must be pressed sequentially to select the
brand. When the correct brand is displayed, press the START/STOP key (7) to
confirm.

i) The LCD window now indicates "purge". Press and hold the PRIME/BOLUS

key (8) to prime the extension set. For safety reasons connect the patient only
after correct loading and purging of the syringe.

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

Use the UP/DOWN keys (12) to select the required rate in ml/h indicated in the
RATE display (9). 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 the full volume of the syringe is to be infused, make the patient connection and
press the START key (7) to commence the infusion.

If a specific volume 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.

3.3. Pump running

When the pump is running, the green syringe symbol flashes. 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, syringe brand and size, pressure and pressure limit,
press the OPTION key (5) sequentially and observe the LCD window (6) until the
required data is displayed.

If a specific volume to be infused was selected the pump automatically switches

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to KVO operation when this volume has been infused and an audible and visual
alarm (14) activates.

The near end of syringe alarm activates three minutes before the syringe is
empty (audible and visual warning). The time before end of syringe may be
adjusted (by a technician) as required. Press the ALARM SILENCE key (5) to
silence the audible alarm for 2 minutes.

3.4. Resetting the volume infused

In order to reset the volume infused, stop the pump by pressing the STOP key (7).
Press the OPTION key (5) for 2 seconds until the VOLUME display (10) flashes.
When the LCD window (6) displays "000", confirm this by pressing the
START/STOP key (7) to reset the volume infused to zero. If it is not desired to
reset the volume infused, press the OPTION key (5) 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 (5) and the BOLUS key (8) together.
The bolus rate is displayed in the RATE window (9) and the bolus volume infused
is displayed in the VOLUME window (10). The LCD window (6) 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 (8) for 2 seconds until the display in the VOLUME window
(10) flashes. The desired bolus volume in mls can then be preset in the VOLUME
display using the VOLUME keys (13). Press the BOLUS key (8) to deliver the
bolus automatically. If no bolus is required, press the OPTION key (5) to cancel.

During automatic bolus delivery, the RATE display (9) indicates the bolus rate
and the VOLUME display (10) indicates the bolus volume infused. The LCD
window (6) indicates "Bolus automatic".

To stop the pump at any time press the STOP key (7).
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. Removing or changing a syringe

Press the START/STOP key (7) to stop the pump. Open the door (15) and open
the syringe clamp (2). The syringe plunger unlocks automatically and the drive
head (3) extends fully to the right.

If a new syringe is to be fitted to continue the infusion, it can be loaded as in
section 3.1 without switching the pump off. Rate, volume to be infused and
volume infused data are stored.

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 (7) and the ON/OFF key (11) together to recall all data.

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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. When the syringe has been primed, press the START/STOP key (7) to
confirm. Then press and hold the OPTION key (5) until the RATE and VOLUME
displays flash. The time in hours and minutes may be selected in the RATE
display (9) and the volume selected in the VOLUME display (10). The pump
automatically calculates the infusion rate. Check this carefully in the LCD window
(6) before starting the infusion.

3.9. Pressure system

The Syramed SP6000 has automatic pressure monitoring whereby the pressure
in the system is measured via the syringe plunger. 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.
Example (Injectomat):

- 50 ml syringe, 25 ml/h, press. limit 800 mBar, Time to alarm: 160 sec.

- 10 ml syringe, 5 ml/h, press. limit 300 mBar, Time to alarm: 100 sec.

Manual setting:

Press the OPTION key (5) sequentially to display pressure and alarm pressure
limit in the LCD window (6). Hold down the OPTION key (5) until the VOLUME
display (10) flashes "Lxxx". The pressure limit may be manually set using the
VOLUME keys (13) in the VOLUME display (10) 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.

Example (Injectomat):

- 50 ml syringe, 25 ml/h, press. limit 500 mBar, Time to alarm: 100 sec.

- 10 ml syringe, 5 ml/h, press. limit 200 mBar, Time to alarm: 70 sec.

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 (5) sequentially to display date and time in the LCD
window (6). Hold the OPTION key (5) down until the display flashes. The time
may be set using the volume keys (13) in the Volume display (10), e.g. h9.45 =
9:45 am. This can also be done while the infusion is in progress.
The syramed 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 (13) together whilst switching the pump on. This
enables the Service Mode. Select the RATE display (9) according to the
following table using the RATE keys (12). Then select the corresponding data in
the VOLUME display (10) using the VOLUME keys (13). Press the START key (7)
each time to confirm each setting:

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Rate display (9) Volume display (10) Function

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 (11) to switch the pump off.
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.
Syringes, filters and extension sets must be CE marked.

The Instructions for Use and the mains power supply cable are included as
standard equipment with the Syramed µSP6000.

3.13. START/STOP key (7)

The START/STOP key (7) 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 (8)

The PRIME/BOLUS key (8) 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 (5)

The audible alarm may be silenced for 2 minutes using the ALARM
SILENCE/OPTION key (5). 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 (11)

The pump may be switched off using the ON/OFF key (11) 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 (11) 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 0.3 ml/h and

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