Arcomed syramed mSP6000 User manual

Maintenance Manual
syramed®µSP6000
syringe pump
0123
Swiss Made
ARCOMED AG
8105 Regensdorf / Zürich
an ISO 9001 company
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

VOLUME ML
syramed 6000
Front view
16
11
RATE ML/H
9
17 12
ON
OFF
13 10
4
1
2
87
syramed
µSP6000
14 5
START
2 MIN
DEFECT
RATE
KVO
STOP
OPTION ALARM
PRIME
BOLUS
6
15
arcomed ag
3

syramed µSP6000
Rear View
16
20 21
22
18
19

Index numbers
1Door latch
2Syringe clamp
3Drive head
4Syringe
5ALARM SILENCE/OPTION key
6LCD window for messages and infusion parameters
7START/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
1Introduction 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
2Specifications 3
3Operation 4 - 9
3.18. Using the pump in parallel or
multiple infusions 9
4Alarm system 10 - 12
5.1 Warranty 12
5.2 Design changes 12
6Saftey checks 13
7Performance data 13
8Technical description 16
9Trouble 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, EssexCM13 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:
Nurse call
IR Interface RS232
(Infrared)
IPX 1
CF (cardiac floating) part
CAUTION: consult accompanying
documents
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
Page 4

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
Page 5