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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
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ON |
RATE ML/H |
VOLUME ML |
2 MIN |
START |
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syramed |
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PRIME |
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µSP6000 |
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BOLUS |
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OFF |
OPTION |
STOP |
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ALARM |
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RATE |
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arcomed |
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syramed 6000 Front view
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20 21
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syramed µSP6000 Rear View
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Index numbers |
1 |
Door latch |
2 |
Syringe clamp |
3 |
Drive head |
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Syringe |
5 |
ALARM SILENCE/OPTION key |
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LCD window for messages and infusion parameters |
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START/STOP key |
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PRIME/BOLUS key |
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RATE display |
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VOLUME display |
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ON/OFF key |
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RATE keys |
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VOLUME keys |
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Alarm indicators |
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Door |
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Carrying handle |
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Power and running indicators |
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Mains power connector |
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Mains fuse |
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Nurse call connector |
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IR interface |
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Pole clamp |
CONTENTS |
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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
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multiple infusions |
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Alarm system |
10 - 12 |
5.1 |
Warranty |
12 |
5.2 |
Design changes |
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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 |
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Annex A |
Drawings |
Annex B |
Schematics |
Annex C |
Component layouts |
1.Introduction
1.0Introduction
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.
1.1Mounting 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. ++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
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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
!
IPX 1
Nurse call
Interface RS232 (Infrared)
CF (cardiac floating) part
CAUTION: consult accompanying documents
Drip-proof
class II double insulated
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2.Specifications
CE Marking
Classification
Software revision
Flow rate range (ml/h)
Flow rate increments (ml/h)
Volume range (ml)
Volume increments (ml)
Syringe size (ml)
Syringe brands
Syringe nearly empty alarm Bolus volume after occlusion Overinfusion in case of electrical or mechanical defect
Keep vein open rate (KVO) Bolus rate, Prime rate Alarm pressure limit
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
Max. storage period
Permitted temperature range (operation/storage) Permitted relative humidity Safety certification
No. G5 01 08 13006 010 IIb
1.xx
0.1 - 500 (750 max)
0.1
0.1 - 999.9
0.1 5, 10, 20, 30, 50/60
(Automatic size recognition)
B Braun, Fresenius, BD, Monoject, Terumo, Codan, other brands on request 3 mins (adjustable)
Automatic bolus reduction (see also 3.9) 1.5 ml max.
0.3 ml/h, adjustable
1500 ml/h (50/60 ml syringe), adjustable
0 - 999 mbar/mmHg
3 - 12 hours (dependent on rate set)
15 hours/20 hours
230 VAC+10%-15%, 50/60 Hz
12-15V AD/DC
8.5 VA
T200 mA Class II
IPX 1, drip proof < 40µA CE-Class A 24V/0.2A
CF (cardiac floating) 245x90x180 mm (WxHxD) ABS plastic, UL listed
2.3 kg (approx.)
3 months without charging
15°C - 35°C / 0°C- 40°C
20-90% max. (no vapor deposit) DIN IEC 601 Part 1
EN55011 Radio interference IEC601-1-2 Susceptibility IEC601-2-24
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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 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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