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Syringe Pump Operator's Guide

This document is an operator's manual for syringe infusion pumps made by Wilburn Medical USA, including models SEP-10S Plus, SEP-12S Plus, and SP-12S Pro. It provides instructions on pump operation, programming infusion parameters, starting and stopping infusion, and advanced features like drug protocols. Key sections cover loading the syringe, purging air bubbles, selecting infusion settings, reviewing/changing programs, and using bolus doses and lockout features. Safety warnings advise reading the full manual before use to ensure proper operation.

Uploaded by

Valeriu Popescu
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
620 views57 pages

Syringe Pump Operator's Guide

This document is an operator's manual for syringe infusion pumps made by Wilburn Medical USA, including models SEP-10S Plus, SEP-12S Plus, and SP-12S Pro. It provides instructions on pump operation, programming infusion parameters, starting and stopping infusion, and advanced features like drug protocols. Key sections cover loading the syringe, purging air bubbles, selecting infusion settings, reviewing/changing programs, and using bolus doses and lockout features. Safety warnings advise reading the full manual before use to ensure proper operation.

Uploaded by

Valeriu Popescu
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Document History
  • Introduction
  • Pump Description
  • Basic Operation
  • Programming of Infusion Parameters
  • Infusion
  • Advanced Features
  • Setup Menu
  • Visual and Audible Alarm Signals
  • Maintenance and Storage
  • Technical Specifications
  • Electromagnetic Emissions
  • Drawing of Cables
  • Warranty and Service Information
  • Accessories

Shop for Syringe Pump Products at www.WilburnMedicalUSA.

com

Operator’s Manual

SEP-10S Plus
SEP-12S Plus
SP-12S Pro
SYRINGE INFUSION PUMPS

Prior to using this pump, read this manual carefully to fully


understand the pump’s functionality and to ensure safe and
proper operation.
Document history

Original issue (BN037047EN): September 2006, firmware version: SPP02.


Revision 1.0 (BN037047EN-P01): November 2006, firmware version: SPP02.
Revision 2.0 (BN037047EN-P02): March 2007, firmware version: SPP03.

2 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
CONTENTS
Document history .........................................................................................................................................................2

CONTENTS ....................................................................................................................................................................3
Compliance ..................................................................................................................................................................6
Material Specifications ................................................................................................................................................7
Hazardous components to be separated at the end of life............................................................................................7

INTRODUCTION ..........................................................................................................................................................8
Overview ......................................................................................................................................................................8
Pump description .........................................................................................................................................................8
Serial Number Description ..........................................................................................................................................8
Items supplied with pump.............................................................................................................................................9
Operational Warnings and Cautions ...........................................................................................................................9
Symbol definition .......................................................................................................................................................10
Warnings....................................................................................................................................................................11
Cautions.....................................................................................................................................................................12
Notes ..........................................................................................................................................................................14

1. PUMP DESCRIPTION ............................................................................................................................................15


Front view of SEP-10S Plus.......................................................................................................................................15
Front view of SEP-12S Plus, SP-12S Pro ..................................................................................................................15
Rear Panel Assembly .................................................................................................................................................16
Keypad indicators reference guide ............................................................................................................................17
Keypad keys reference guide......................................................................................................................................17

2. BASIC OPERATION...............................................................................................................................................18
Switching pump on.....................................................................................................................................................18
Switching pump off.....................................................................................................................................................19
Loading the syringe....................................................................................................................................................19
Syringe removal .........................................................................................................................................................21
Purging ......................................................................................................................................................................21
Recommended Syringes .............................................................................................................................................23

3. PROGRAMMING OF INFUSION PARAMETERS ............................................................................................24


Selecting drug name...................................................................................................................................................24
Selecting dose mode (only in SEP-12S Plus and SP-12S Pro)...................................................................................24
Programming drug concentration (only in SEP-12S Plus and SP-12S Pro) .............................................................25
Programming patient’s weight (only in SEP-12S Plus and SP-12S Pro) ..................................................................25
Programming infusion rate or volume over time .......................................................................................................25
Programming volume to be infused (VTBI) ...............................................................................................................26

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 3


PUMP MANUAL
Programming bolus rate ............................................................................................................................................26
Programming bolus dose ...........................................................................................................................................27
Programming occlusion pressure level......................................................................................................................27

4. INFUSION.................................................................................................................................................................28
Starting and stopping infusion ...................................................................................................................................28
Bolus dose injection ...................................................................................................................................................28
Review of programmed parameters ...........................................................................................................................29
Change of programmed parameters ..........................................................................................................................29
Standby mode.............................................................................................................................................................30
Clearing infused drug volume, total infused volume..................................................................................................30
Locking and unlocking keypad...................................................................................................................................31
Viewing date and time................................................................................................................................................31
Turning off/on the display backlight (night mode).....................................................................................................31

5. ADVANCED FEATURES .......................................................................................................................................32


Drug protocols (optional in SEP-12S Plus and SP-12S Pro, unavailable in SEP-10S Plus) ....................................32
Parameters used to configure drug protocol .............................................................................................................32
Creating drug protocol ..............................................................................................................................................32
Modyfing drug protocol .............................................................................................................................................34
Infusion of drug with protocol ...................................................................................................................................34
Drug protocol review.................................................................................................................................................34

6. SETUP MENU ..........................................................................................................................................................35


Pump mode ................................................................................................................................................................35
Event history review (optional)..................................................................................................................................35
Syringe set..................................................................................................................................................................35
Drug set .....................................................................................................................................................................35
Default drug set .........................................................................................................................................................36
Language set ..............................................................................................................................................................36
Date and Time setting ................................................................................................................................................36
Parameter set.............................................................................................................................................................36

7. VISUAL AND AUDIBLE ALARM SIGNALS ......................................................................................................38

8. MAINTENANCE AND STORAGE........................................................................................................................40


Cleaning Overview.....................................................................................................................................................40
Preventive Maintenance.............................................................................................................................................41
Battery Operation Overview ......................................................................................................................................41
Storage.......................................................................................................................................................................41
Test routines...............................................................................................................................................................42
Repair ........................................................................................................................................................................42

9. TECHNICAL SPECIFICATIONS .........................................................................................................................43

4 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Volumetric Accuracy of the System............................................................................................................................45
Startup Graph Description ........................................................................................................................................45
How Trumpet Curve Graphs are Interpreted.............................................................................................................46
How Trumpet Curves Can Be Used ...........................................................................................................................46
Startup and Trumpet Curves ......................................................................................................................................47
Influences of Back Pressure at 5 ml/h........................................................................................................................47
Maximum Infusion Pressure Generated.....................................................................................................................48
Alarm Delay at Occlusion..........................................................................................................................................48
Bolus Volume at Occlusion ........................................................................................................................................48
Automatic Bolus volume accuracy .............................................................................................................................48

10. GUIDANCE AND MANUFACTURER'S DECLARATION ON ELECTROMAGNETIC EMISSIONS.....49


Electromagnetic Compatibility Statement..................................................................................................................49

11. DRAWING OF CABLES FOR MULTIFUNCTIONAL CONNECTOR (MFC).............................................55

12. WARRANTY AND SERVICE INFORMATION................................................................................................56


Warranty ....................................................................................................................................................................56
Service Information....................................................................................................................................................56

13. ACCESSORIES ......................................................................................................................................................57

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 5


PUMP MANUAL
This symbol represents compliance with the essential requirements according to MDD 93/42/EEC (14 June
1993) of the European Communities concerning medical devices.

Compliance
The pumps comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-24 standards.

SEP-10S Plus and SP-12S Pro intended for use in road ambulances comply with EN 1789:1999.

SEP-10S Plus and SP-12S Pro - FDA approved.

The pumps have been manufactured by the company, which has implemented and maintains a Quality
Assurance System meeting the requirements of the standards EN ISO 9001:2000 and EN ISO 13485:2003.

Devices: SEP-10S Plus, SEP-12S Plus, SP-12S Pro (hereinafter – the pump)

Manufacturer: Viltechmeda, 125 Kalvariju Str., 08221 Vilnius, Lithuania.

6 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Material Specifications
Steel
Stainless Steel
Copper
Aluminium
Bronze
Brass
Polyamide PA6 (PA)
Polycarbonate (PC)
Composition of Polycarbonate and ABS (PC+ABS)
Battery NiMH

Hazardous components to be separated at the end of life

Battery NiMH
Printed circuit boards containing brominated flame retardant
(TBBA 79-94-7) and lead
Electrolyte capacitors
AC power lead

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 7


PUMP MANUAL
INTRODUCTION

Overview
- The pump is designed to meet the fluid and drug delivery
requirements of today’s changing clinical environment.

- The pump is indicated for infusion via intravenous (IV), intra-


arterial (IA), epidural, or subcutaneous routes of administration.
Infusion rates are programmable from 0.1 to 1500 ml/h.

- The pump accepts wide range, single-use syringes with volumes


from 10 to 100 ml, optional – 5 ml.

- The pump can be custom-configured to select key features that


meet specific requirements. The selected options can be easily
reviewed and the chosen configuration can be changed to meet
new or different requirements.

Pump description
SEP-10S Plus – General ward syringe pump

SEP-12S Plus – Anaesthesia syringe pump

SP-12S Pro – Universal syringe pump

Serial Number Description

XXXX yy

year the pump was manufactured

sequential number (0001 – 9999)

8 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Items supplied with pump
1. The pump
2. Operator‘s manual
3. AC power cord
4. Packaging
5. Spare parts: cap B8123009 – 2 pcs.

Additional items supplied with pump to be used in ambulance:


1. The pump with clamp for Draeger bar mounting
2. 12VDC cable

Operational Warnings and Cautions

General
- If a software change occurs and the operation/specification for
the device changes, new or additional operating instructions will
be issued, if needed.

- Although the pumps have been designed and manufactured to


exact specifications, it is not intended to replace trained personnel
in the supervision of IV infusions.

- In accordance with the international standard, IEC 60601-1


Medical Electrical Equipment – Part 1: General Requirements for
Safety, the pump is classified as:
• Class II
• Type CF
• IPX4 (splashproof)
• Not suitable for use with flammable anesthetic mixtures with air,
oxygen or nitrous oxide
• Continuous operation

- Prior to operating the pump, the user should carefully read this
manual to fully understand the functionality and to ensure safe and
proper operation.
- This manual has been developed with consideration to the
requirements in the International Standard, IEC 60601-2-24
Medical Electrical Equipment – Part 2-24: Particular Requirements
for Safety of Infusion Pumps and Controllers. Data presented in
the Technical Specifications reflect specific test conditions defined
in this standard. Other external factors such as, varying back
pressure, temperature, head height, set usage, fluid restrictions,
solution viscosity, or combinations of these factors, may result in
deviations from the performance data enclosed.

Definitions:
Warning messages indicate a possible hazard which, if not
avoided, could result in severe personal injury or death.
Caution messages indicate a problem or unsafe practice which, if
not avoided, could result in minor or moderate personal injury,
product or property damage.
Note messages provide supplemental information to the
accompanying text.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 9


PUMP MANUAL
Symbol definition

Attention consult accompanying documents

Protection Class II

CF type device (leak currents protection)

IPX4 Splashing water protected

Complies with MDD 93/42/EEC directive

Nurse call connector (optional)

RS 232 RS232 interface

Do not dispose of this product as unsorted municipal waste.


Follow local municipal waste ordinances for proper disposal provisions
to reduce the environmental impact of waste electrical and electronic
equipment (WEEE).

Complies with the directive 95/54/EEC concerning the suppression of


radio interference in road ambulances (optional in SEP-10S Plus and SP-
12S Pro).

10 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Warnings
Possible explosion hazard if used in the presence of flammable
anesthetics.

Always read and follow the instructions which accompany the


syringe and extension sets you are using. Carefully follow the
instructions for priming the set, as well as the recommended set
change interval. Set use should not exceed the label set change
interval.

Viltechmeda will assume no responsibility for incidents which


may occur if the product is not used in accordance with product
labeling.

The pump has no means to detect air presence in the extension


set. The pump operator shall ensure there is no air in the
extension set

Do not mount the pump in a vertical position with the syringe


pointing upwards as this could lead to an infusion of air which
may be in the syringe.

Do not connect the IV extension set to the patient when purging.

This device should be used only with Viltechmeda accessories


specified for this device. There are risks associated with using
anything other than the recommended accessories with this
device.

The specified accuracy of the syringe pump can only be


maintained when recommended syringe and accessories are
used.

Inter-connection of several devices into a single infusion system


can have substantial influence on the accuracy of the infusion
rate, at least for one of these devices. In such situations, the
operation of devices using gravitational forces can be unstable
or impossible at all.

The syringe should be disposed of in an appropriate manner,


considering the nature of the residual fluid that may be
contained within, in accordance with the hospital disposal
practices.

Though the factory-supplied configuration settings are suitable


for most therapies, the operator and hospital professionals
should verify that the pump settings are appropriate for the
clinical application.

Do not use hard or sharp objects on the keypad.

Be sure to PURGE THE SYSTEM OF ALL AIR BEFORE


ADMINISTERING ANY MEDICATION. Failure to follow this normal
infusion procedure could precipitate serious consequences.

Remember that the volume of fluid contained in the connecting


tubing is a residual amount and cannot be infused. Allow for this
extra volume of fluid when initially filling the syringe.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 11


PUMP MANUAL
CAUTION must be employed to assure that the pump
is in good working order before putting it into use. If the pump is
being operated on battery power alone, ensure
that the battery has been charged as described in this manual.

Verify all program data before pressing START.

Wipe off spills immediately. Do not allow fluid or residues to


remain on the pump.

Caution must be exercised in the selection of drugs intended to


be delivered via any infusion pump. If the drug contained in the
syringe will be exposed to extreme environmental conditions for
prolonged time periods, IT IS IMPORTANT TO SELECT DRUGS
THAT WILL NOT CHANGE PHARMACOLOGICALLY UPON SUCH
EXPOSURE.

Epidural administration of drugs other than those indicated for


epidural use could result in serious injury to the patient.

• Epidural administration of anesthetics is limited to short term


infusion (not to exceed 96 hours) with indwelling catheters
specifically indicated for short term anesthetic epidural drug
delivery.
• Epidural administration of analgesics is limited to use with
indwelling catheters specifically indicated for either short term
or long term analgesic epidural drug delivery.
• To prevent infusion of drugs not indicated for epidural use, do
not use IV administration sets incorporating injection sites
during epidural delivery.
• Clearly distinguish pumps used for epidural drug delivery from
pumps used for other routes of administration.

Cautions

As with all medical electronic equipment, care must be


exercised to avoid exposing this device to powerful sources of
electromagnetic interference. This device design has been
tested to current European standards and guidelines for medical
devices. The device was not found to be affected adversely by
these susceptibility tests and will perform safely. The device’s
emissions also were found to be acceptable.
Using the pump near operating equipment which radiate high
energy radio frequencies (such as electrosurgical/cauterising
equipment, two-way radios, or cellular telephones)
may cause false alarm conditions. If this happens, reposition
the pump away from the source of interference; or
turn off the pump.

This unit emits a certain level of electromagnetic radiation, which


is within the levels specified by IEC 60601-2-24 and IEC 60601-1-
2.

12 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
The RS232 is a standard (optional – SEP-10S Plus) feature on the
syringe pump. Connection to the computer while pump is
connected to the patient is prohibited.

Accessory equipment connected to the analog and digital


interfaces must be certified according to the respective IEC
standards (e.g. IEC 950 for data processing equipment and IEC
60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the system standard IEC
60601-1-1. Everybody who connects additional equipment to the
signal output configures a medical system, and is therefore
responsible that the system complies with the requirements of
the valid version of the system standard IEC 60601-1-1. If in
doubt, consult manufacturer’s service department.

Refer to the Service Manual for further information regarding the


RS232 interface.

The assessment for suitability of any software used in the


clinical environment to receive data from syringe pump lies with
the user of the equipment.

When infusing through a central line catheter, Viltechmeda


recommends using sets with a Luer lock adaptor.

Follow the cleaning schedule and methods defined under


Chapter 8 Maintenance and Storage, to ensure proper
maintenance of the device.

Do not clean, disinfect, or sterilise any part of the device by


autoclaving or with ethylene oxide gas. Doing so may damage
the device and void the warranty. Only external parts of the
device should be disinfected.

Do not use the following chemicals on the device, as they will


damage the front panel: acetone, acetoaldehyde, ammonia,
benzene, hydroxytoluene, methylene chloride, and ozone. Do not
use cleaners containing n-alkyl dimethyl ethylbenzyl ammonium
chloride unless they appear in the list of recommended cleaners
in chapter 8.
When attaching the pump to an IV pole or other
mounting locations, ensure it has been securely clamped.

Ensure device is mounted where main body is easily accessible


and syringe can be installed in the loading mechanism without
stretching or kinking the tubing.

To avoid personal injury, ensure that the IV pole is stable and


secure. Ensure that the pole is able to support the pump, along
with any other devices, without tipping or falling.

Only use approved and pressure proved syringes with Luer lock
connections and lines in accordance with chapter 2.

It is recommended that the extension lines are changed


according to hospital protocols.

It is recommended to minimize number of parameters, types of


syringes, drug names and other functions leaving only that

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 13


PUMP MANUAL
necessary for work. It will help to avoid errors in parameters
programming and thereby decrease patient’s risk.
Notes
Before initially powering on the device, charge the battery.

14 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
1. PUMP DESCRIPTION

Front view of SEP-10S Plus

1. Display 2. Indicators 3. Keypad

Front view of SEP-12S Plus, SP-12S Pro

1. Display 2. Indicators 3. Keypad 4. Key to select dimensions


of parameters

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 15


PUMP MANUAL
Rear Panel Assembly

1. Syringe driver arm 7. Cap


2. Slot for inserting the push-button of 8. Mounting pole clamp
the syringe plunger 9. Fuse holder
3. Rubber bellows 10. Mains inlet
4. Slot for inserting the finger grips of 11. MFC*
the syringe barrel 12. Audio volume control
5. Syringe clamp
6. Mounting clamp handle

* - optional in SEP-10S Plus

16 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Keypad indicators reference guide
The green BATTERY LED lights when the pump is
operating on battery power. Flashing if LOW BATTERY
alarm condition occurs.
The green MAINS LED lights when the pump is connected
to the AC and battery is charging.
During infusion, three yellow LEDs are sequentially
flashing. If the rightmost LED is on permanently – the
infusion is stopped.
Keypad keys reference guide
Key to switch the pump on/off; keep it pressed for several
seconds in order to switch off.

Key to start/stop the infusion.

Key to move the syringe driver arm rapidly to the left-hand


side during syringe insertion or to initiate the Bolus mode;
it is also intended for air removal from the extension set
after syringe insertion.

Key to move the syringe driver arm to the right-hand side.

Keys to scroll up/down the list of parameters and syringe


brands or answer positively or negatively the dialog
questions.

Key to select dimensions of parameters when programming


(only in SEP-12S Plus and SP-12S Pro).

Key to program (modify) parameters. Pressing it once more


restores previous values.

Key to confirm the selected parameter.

Numerical keys to enter digits of the parameter being


programmed.

Key to select additional functions or to review programmed


parameters.

Key to cancel the numerical value or the meaning of the


parameter or silence the alarm signal. It deletes TOTAL
INFUSED and INFUSED DOSE values and clears the
numerical value on display when programming.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 17


PUMP MANUAL
2. BASIC OPERATION

Switching pump on
1. Fasten the pump to the stand by turning the pole clamp handle.
2. Connect the power cord to the corresponding socket on the
pump.
3. Secure the power cord to the pump by means of the metal
clamp.

4. Connect the power cord into the mains receptacle. The green
indicator will light on.

5. Switch the pump on by pressing the ON/OFF key.

There are three possible situations:


a) the following message is displayed:
Insert SYRINGE
into SLOTS!

Insert the syringe filled and with the extension set connected (see
Section - Loading the syringe);

or b) the following message is displayed:


Close CLAMP!

Remove air from the extension set and fasten the syringe by means
of the clamp (see Section - Loading the syringe);
or c) the following message is displayed (if syringe inserted prior
to switching the pump on):
Syringe:
XX ml (syringe brand name)

Confirm syringe size and name (see Section - Loading the syringe)

NOTES:
1. If the following message is displayed:

18 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
NO MAINS!!!
Check power cord

after pressing the ON/OFF key, it means the pump is not


connected to the mains. Either connect the pump to the mains or
confirm by pressing the C key that the pump will be powered with
the internal battery.
2. If the message:

VERY LOW BATTERY

is displayed after pressing the ON/OFF key when the pump is


connected to the mains, then switch it off by pressing the ON/OFF
key once more and wait for approximately 15 min to allow the
internal battery to charge. Then the pump will be prepared for
syringe insertion and infusion parameter programming.
The internal battery may be charged permanently because
it is protected against overcharging. In order to have the battery
fully charged, keep the pump constantly connected to the mains.

Switching pump off


The pump is switched off by keeping the ON/OFF key pressed for
3 sec.

Loading the syringe

1. Lift the syringe clamp to its upper position.


2. Turn the syringe clamp counter-clockwise by 90°.

3. Pressing the key move the syringe driver arm to the right
to the distance needed for syringe insertion.

Insert the filled syringe into the pump when the following message
is displayed:

Insert SYRINGE
into SLOTS!

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 19


PUMP MANUAL
4. Insert the syringe push-button into the syringe driver arm slot to
the depth to ensure minimal distance between the syringe barrel
and the pump body.
5. Holding the syringe by hand, keep pressing the BOLUS key
until the syringe finger grips will fit into the corresponding pump
slot.

6. By pressing the syringe barrel and push-button down, insert


fully the syringe finger grips and push-button into corresponding
pump slots.
The cylindrical syringe barrel shall lay on the pump body with no
gap. Axes of the syringe barrel and its plunger shall be on the
same line.

The following message is displayed:

Close CLAMP!

7. Turn the syringe clamp clockwise by 90°.


8. Lower the syringe clamp onto the syringe barrel.

The syringe size sensor determines the syringe size automatically.


The following message is displayed:

Syringe:
XX ml(syringe brand name)

where: XX – syringe size.

9. If the syringe size and brand are correct, press the ENTER key.
10. Otherwise press the PROG key.
11. Select the required syringe name with the scrolling keys.
12. Confirm the selected syringe name and size selected by
pressing the ENTER key.

Use of syringes not pre-programmed or incorrect insertion of the


syringe increase patient’s risk.

20 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
NOTES:
1. When you insert a syringe having a diameter not complying with
any syringe installed, the following message is displayed:

ILLEGAL SYRINGE!
Change SYRINGE!
2. When you insert a syringe of different type (brand or size) than
used previously, the following message is displayed:

CHECK SYRINGE!
(syringe size and brand)?

If inserted syringe size and brand are the same as displayed, press
the YES key or the ENTER key. Otherwise press the PROG key and
select different syringe type or check the correctness of syringe
insertion.
3. User can minimize syringe list through setup menu in
accordance with the chapter 6.

Syringe removal

13. Lift the syringe clamp to its upper position.


14. Turn the syringe clamp counter-clockwise by 90°.

15. Remove the syringe.

Purging
Air can be removed from the extension set after syringe is inserted
and brand confirmed, before entering the STOP mode (before
pressing the YES key when the message

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 21


PUMP MANUAL
Total: XXX ml
Ready to run?
is displayed.)
In order to remove air from the extension set press the BOLUS
key. The following message is displayed:

PURGE?
press BOLUS

The syringe extension set should not be connected to the


patient during air removal.

22 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Recommended Syringes
5 ml
10 ml 20 ml 30 ml 50/60 ml 100 ml
(optional)
BD PLASTIPAK √ √ √ √ √
BD PRECISE √ √
BD PrecisG √
BD PERFUSOR √
BD USA √
MONOJECT (Kendall) √ √ √ √ √
OMNIFIX (BBraun) √ √
PERFUSOR (BBraun) √
IVAC √
INJECTOMAT (Fresenius) √
TERUMO (Europe) √ √ √
TERUMO (USA) √ √ √ √
NIPRO √ √ √ √
JMS √
KD-JECT III √ √ √ √
ELVIONY √
EXELMED √
DIMES √ √
DISPOMED √
PolfaBol √
PolfaLub √ √
JANPOL √
HAYAT PERF √
HAYAT 10, 20, 50 √ √ √
MAYBOD YAS √
WEIHAI √ √ √
XINHUA √ √ √
HONGDA √
HUI CHUN √ √ √
YAZD √
POMAT √
MEDIZ √
SHIFA √ √ √
INFUJECT √ √
PENTAFERTE √
ONCE √ √ √
MK BG √
USC √
DISPO VAN √ √ √
VITTA √ √ √
ROMSONS √ √ √
V.MED √
NOTE:
The Manufacturer of the pump can change the syringe list, including syringes of new brands or removing
the included ones. The list of syringe brands is dependant on the software version of the pump.
Only use approved and pressure proved syringes with Luer lock
connections and lines.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 23


PUMP MANUAL
3. PROGRAMMING OF INFUSION
PARAMETERS
3

All parameters can be programmed after syringe is loaded and


syringe make confirmed. When all the parameters are programmed
and infusion started pump keypad can be locked.

Previously programmed parameters are reviewed using the


scrolling up/down keys. It is necessary to confirm all the
parameters. To confirm the parameter press the ENTER key or the
scrolling up key. Only then the pump will switch to STOP mode.

In order to modify the selected parameter, press the PROG


key. Enter the parameter value using the numerical keys and press
the ENTER key to confirm it. Using the ml↔mg, during
programming of parameter value, it is possible to select the
required measurement unit (only in SEP-12S Plus and SP-12S
Pro).
When the parameter has no numerical value, then select the
required message by means of the scroll keys and confirm it by
pressing the ENTER key. To cancel newly entered (selected) value
and restore previous value press the PROG.

Selecting drug name


1. After syringe is inserted and brand confirmed, press the PROG
key.
2. Select the required drug name by the scrolling keys.
3. Press the ENTER key to confirm selected drug name.

NOTES:
1. If you don’t want the drug name to be displayed select
“NONE” from the drug list and press ENTER.
2. You can enter new drug name to the list in accordance with
instruction given in the chapter 6 of this manual.

Selecting dose mode (only in SEP-12S Plus and SP-12S Pro)


Select the message

Dose mode:
1. Press the PROG key.
2. Select the required infusion rate unit by pressing the ml↔mg
key.
3. Press the Enter key to confirm the selected dose mode.

24 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
NOTE:
Available only if mass units enabled in setup menu.

Programming drug concentration (only in SEP-12S Plus and SP-12S Pro)


Select the message

Concentration:
on the display.
1. Press the PROG key.
2. Select the required drug concentration measurement unit using
the ml↔mg key.
3. Enter the required value of drug concentration using the
numerical keypad.
4. Confirm drug concentration by pressing the ENTER key.

NOTES:
1. In order to have drug concentration calculated from entered
drug mass and diluent volume, select the message
Calculate
concentration?
using the ml↔mg key.
Press the YES key. Enter drug mass and diluent volume
analogously to concentration programming above.
2. Drug concentration can be programmed only if infusion rate is
set in mass units.
3. Drug concentration value can not be set to 0.

Programming patient’s weight (only in SEP-12S Plus and SP-12S Pro)


Select the message

Patient weight:
on the display.
1. Press the PROG key.
2. Enter the patient weight using the numerical keypad.
3. Press the ENTER key to confirm the selected patient weight.

NOTE:
The programmed patient’s weight shall not exceed the value of
200 kg.

Programming infusion rate or volume over time


Select the message

Infusion rate:
on the display.
1. Press the PROG key.

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PUMP MANUAL
2. Enter the required value of infusion rate using the numerical
keypad.
3. Press the Enter key to confirm the selected infusion rate.

NOTE:
In order to have infusion rate calculated from entered volume to
be infused (VTBI) value and time, press the F key during
infusion rate programming (i.e. after pressing the PROG key).
The following message is displayed:

Volume over
time?

Press the YES key. Enter VTBI value and Time analogously to
infusion rate programming above.

Programming volume to be infused (VTBI)


Select the message

VTBI:
on the display.
1. Press the PROG key.
2. Enter VTBI value using the numerical keypad.
3. Press the ENTER key to confirm VTBI value.

NOTE:
To reset previously entered value and execute the infusion without
the preset VTBI, set the VTBI value to 0.

Programming bolus rate


Select the message

BOLUS rate:
on the display.
1. Press the PROG key.
2. Enter the required value of Bolus rate with the numeric keypad.
When Bolus function is not required, the Bolus rate value will be
set to zero.
3. Press the ENTER key to confirm the selected Bolus rate.

NOTE:
Bolus rate can be programmed only if BOLUS RATE
PROGRAMMING feature enabled in Setup menu (see chapter 6).

26 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Programming bolus dose
Select the message

BOLUS dose:
on the display.

1. Press the PROG key.


2. Select the required Bolus dose measurement unit using the
ml↔mg key (only in SEP-12S Plus and SP-12S Pro).
3. Enter the required value of Bolus dose using the numeric
keypad.
4. Press the ENTER key to confirm the selected Bolus dose.

NOTE:
When the Bolus rate value is set to zero, the Bolus dose can not be
programmed as well.

Programming occlusion pressure level


Occlusion pressure level can only be programmed for 50/60 and
100 ml syringes. For syringes from 5 to 30 ml only HIGH
occlusion pressure level is available.

Select the message

Occlusion level:
on the display.

1. Press the PROG key.


2. Select the required occlusion pressure level using the scroll
keys.
3. Confirm selected occlusion pressure level by pressing the
ENTER key.

NOTE:
The pump has an anti-bolus function which reduces the pressure
in the syringe and the extension set in case of occlusion and at the
same time diminishes the volume of unwanted Bolus injected to the
patient after removal of the occlusion cause.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 27


PUMP MANUAL
4. INFUSION

Starting and stopping infusion

The infusion is started from the STOP mode when the following
message is displayed:

Stop ... X.X ml


XX ml/h
(X.X – amount of drug in ml, mg or µg, infused during observation
time, i.e. period from the last clearing of this parameter by means
of the C key or by switching the pump off; XX – programmed
infusion rate.)

1. Press the START/STOP key.


Segments of the indicator begin to flash sequentially.
2. You may review the following parameters using the scroll keys:

(drug name)
XXX ml/h
(XXX– infusion rate);

VTBI: XX ml
TIME: XX:XX.XX
(X – Volume to be infused;
XX:XX.XX – time remaining to the end of VTBI);

Infused: X.X ml
Total: XX ml
(X.X – amount of drug infused during current session;
XX – total infused amount of drug);

3. Press the START/STOP key when you wish to stop the infusion.
Segments of the indicator stop flashing and the rightmost
segment only is left on.

Bolus dose injection


Bolus may be injected during infusion only.

1. Press the BOLUS key.


The following message is displayed:

BOLUS?
Press YES/BOLUS

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PUMP MANUAL
NOTE:
While the keypad lock is active bolus injection is prevented. To
inject bolus, first unlock the keypad.

2. If you want to inject the programmed Bolus dose, press the YES
key.
During Bolus performance the following message is displayed:

BOLUS ...X.X ml
XXX ml/h
(X.X – amount of drug injected in Bolus mode,
XXX – Bolus rate).

3. If you want to inject Bolus manually, press and keep the


BOLUS key depressed. Infusion is performed at the Bolus rate
until BOLUS key is released and is accompanied by short beeps.

Review of programmed parameters


Programmed parameters may be reviewed during the infusion or
after stopping it.
1. Press the F key.
2. Select the following message by the scrolling keys:

SETTINGS
REVIEW
or
SETTINGS

3. Press the ENTER key.


4. It is possible to review all the programmed parameters by
pressing the scroll up key.
5. It is possible to exit REVIEW mode by pressing the C key.

Change of programmed parameters


Programmed parameters may be modified only when the
infusion is stopped (Infusion rate can be changed
(Titration) during infusion as well as in the stop mode).

1. Press the F key.


2. Select the following message using the scroll keys:

SETTINGS
3. Press the ENTER key.
4. Select the parameter to be modified by the scroll keys.
5. Press the PROG key.
Enter or select the new value of the parameter (see chapter 3).
6. Confirm the new value of the parameter by pressing the
ENTER key.

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PUMP MANUAL
NOTES:
1. It is possible to change following parameters:
Infusion rate
Bolus rate
Bolus dose
VTBI
Occlusion pressure level
2. Another way to change parameters in the stop mode is as
follows:
Open and close the syringe clamp. When the message

Continue
infusion?
is displayed, press the NO key.
3. If keypad locked, first unlock the keypad to change the
parameters.

Standby mode
Standby mode can be activated if such feature is enabled in
setup menu.
1. Stop the infusion by pressing the START/STOP key.
2. Press the ENTER key.

The following message is displayed:

STANDBY!
Duration: min
3. Enter the pause duration using the numeric keys.
4. Confirm the pause duration by pressing the ENTER key.
The following message is displayed:

STANDBY!
Rest: XX:XX.XX
(X:XX.XX – time remaining to the end of pause).
5. Press the C key to cancel the pause.

Clearing infused drug volume, total infused volume


(available only when infusion is stopped)

1. Select the parameter to be cleared with the scroll keys:

Stop ... X.X ml


XX ml/h
or
Total infused:
X X ml

2. Press the C key.

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PUMP MANUAL
The appropriate question is displayed:

CLEAR infused
volume?
or
CLEAR total
infused volume?
3. Press the YES key, and the corresponding parameter value is
cleared.

Locking and unlocking keypad


Keypad lock feature is enabled/disabled through the setup menu.
When keypad lock feature enabled in setup menu:
1. After infusion parameters have been set and the infusion started
or following the bolus infusion (or after parameter change) the
following message is displayed:

Lock keypad?
Press YES/NO
To enable the keypad lock function press the YES key. Press the
NO key if the keypad lock is not required.

NOTE:
The keypad is locked automatically if none of keys is pressed in
response to above message within 10 sec.

2. In order to disable keypad lock (if enabled) first press the F key,
when message

Keypad LOCKED!
ENTER to unlock

is displayed, press the ENTER key.


3. In order to enable keypad lock (if disabled) first press the F key,
when message

Keypad UNLOCKED!
ENTER to lock
is displayed, press the ENTER key.

Viewing date and time


Date and time can be selected for temporary viewing by means of
the F key and scroll keys in STOP mode and during infusion.

Turning off/on the display backlight (night mode)


Display backlight can be turned off/on using the key. When
running from the internal battery, display backlight is turned off
automatically.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 31


PUMP MANUAL
5. ADVANCED FEATURES

Drug protocols (optional in SEP-12S Plus and SP-12S Pro, unavailable in SEP-10S Plus)
There is a possibility to configure 5 profiles with up to 10 steps
each. Profile scheme can be custom configured for various
applications, i.e. it is possible to set (or disable if unnecessary)
induction dose and pause time after it, program each step rate in
different units and duration, set post profile rate. The profile mode
can be used for Propofol, Dobutamine, Remifentanil and other
drugs infusion requiring special drug administration schemes,
using the best hospital practice.

Parameters used to configure drug protocol


- Drug name
- Dose mode (ml/h, mg/h, mg/min, mg/kg/h, mg/kg/min,
µg/h, µg/min, µg/kg/h, µg/kg/min)
- Concentration (mg/ml, µg/ml)
- Maximum patient weight
- Induction/Loading dose/Initial bolus (mg(µg)/kg, mg, µg, ml)
- Duration
- Step count (0-10)
- Rate N (ml/h, mg/h, mg/min, mg/kg/h, mg/kg/min, µg/h,
µg/min, µg/kg/h, µg/kg/min)
- Time N
- Post-profile mode

Creating drug protocol


To create drug name with protocol enter Drug Set (code 147).

Drug name
Press the PROG key, the following message is displayed:

Replace
drug name?
Press the YES key to edit selected drug name or the NO key and
afterwards the YES key in response to message (to add drug
name):

Add
drug name?
- Enter the new drug name using keys in accordance with the table
shown in chapter 6.
- Having entered required drug name press the F key to place
symbol at the end of drug name ( symbol initiates programming
of protocol).
- Confirm the new drug name by pressing the ENTER key.

32 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Dose mode
Press the PROG key. Select the required rate units using the
ml↔mg key and press the ENTER key.

Concentration (available if dose mode in mass


units)
Press the PROG key. Select the required units using the ml↔mg
key and enter concentration value using the numerical keypad.
Press the ENTER key to confirm.

MAXIMUM PATIENT WEIGHT (available if dose


mode based on patient weight)
Press the PROG key. Enter maximum patient weight using the
numerical keypad and press the ENTER key.

Induction/Loading dose/Initial bolus


Press the PROG key. Select the required units using the ml↔mg
key and enter required value using the numerical keypad.
NOTE:
Using the F key during programming it is possible to select the
naming of parameter: Induction, Loading dose or Initial Bolus.

Duration
Press the PROG key. Enter the Induction/Loading dose/Initial
bolus duration (h:min.sec) using the numerical keypad. Use the
key to skip between hours, minutes and seconds.
NOTES:
1) When duration is disabled (set to 0), Induction/Loading
dose/Initial bolus will be infused at the bolus rate.
2) In order to set the pause after Induction/Loading dose/Initial
bolus it is necessary to leave profile first step rate 0 and set the
step duration conforming to the required pause time (see below 8.
Rate N, Time N).

Step count
Press the PROG key and enter the number of steps using the
numerical keypad. Confirm the entered value by pressing the
ENTER key.

Rate N, Time N
Select one by one and program parameters of each step, pressing
the PROG key and having entered required value confirm it
pressing the ENTER key.

Post profile mode


Press the PROG key, set the post profile rate and press the ENTER
key to confirm (set 0 to stop the infusion after profile completion).

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 33


PUMP MANUAL
NOTES:
1) It is possible to exit drug protocol programming by pressing the
START key and afterwards the YES key. In such case all previous
settings are discarded.
2) To review the programmed protocol, select the drug name with
symbol and press the F key. When the message

PROTOCOL review
is indicated, press the ENTER key and review the drug protocol
using the scroll keys. Press the C key to exit review mode.

Modyfing drug protocol


Enter Drug set and select the drug name with symbol. Press the
PROG key. Following message will be displayed:

Modify protocol?
Press the YES key to start modifying protocol as described above.
Pressing the NO key allows to add new drug name to library.

Infusion of drug with protocol


Infusion of drug protocol can be started after confirmation of
loaded syringe, selection drug name with symbol, setting patient
weight (if rate units based on patient weight), programming of
bolus rate and/or dose (if enabled in set up menu) and setting the
occlusion level.
User is able to change rate and duration of the current step of the
drug profile during infusion.
Use the scroll keys to review current parameters during infusion.
NOTES:
1. Having achieved the required therapeutic level it is possible to
terminate the profile by pressing the STOP key. The following
message will appear:

End Profile?
YES/NO
1.1. Press the YES key. If you press the START key afterwards
infusion will be continued with the rate profile was terminated at
until syringe is emptied.
1.2. Press the NO key. If you press the START key afterwards
infusion will be continued from the point profile was terminated.
2. To stop the Induction/Loading dose/Initial bolus during their
delivery and switch to the first step execution, press the STOP key
and afterwards the START.

Drug protocol review


To review drug protocol parameters, press the F key (available
only having selected and confirmed drug name). The following
message will be displayed:
Protocol review
Press the ENTER key. Review the protocol profile parameters
using the scroll keys.

34 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
6. SETUP MENU

In order to access optional functions or certain parameters, keep


the START key in pressed position and switch the pump on by
pressing the ON/OFF key. When short beep is heard, release the
START key, enter appropriate code (see codes below) using the
numerical keys. Confirm it by pressing the ENTER key.
List of optional functions may be reviewed using the scroll keys. If
displayed name is marked with the asterisk, it means that function
is active. To activate an inactive function press the ENTER key,
and the asterisk will appear in front of the item name.
To deactivate a function, press the C key. The asterisk shall
disappear.
To exit setup menu press the START/STOP key.

Pump mode
(code: 100)
This option is used to set the infusion mode the pump will operate
in. Following infusion modes are available: Continuous rate mode,
Easy pump mode.

Event history review (optional)


(code:111)
This option is used to review the event history. Use the scroll keys
to review the events. In order to get more detailed information on
events use the Event History utility to upload the event history to
PC.
Syringe set
(code: 137)
This option is used to configure the type and size of syringe
permitted for use on the pump. Select all possible syringes, which
may be used, and disable any that should not be used.

Drug set
(code: 147)
This option allows to compose drug library to be used on the
pump. Drug library can comprise up to 30 drug names.

To replace drug name open the drug list and select the drug name
to be replaced by the new one. Press the PROG key, the following
message is displayed:

Replace
drug name?

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 35


PUMP MANUAL
Press the YES key to edit selected drug name or the NO key and
afterwards the YES key in response to message (to add drug
name):

Add
drug name?
Enter the new drug name using keys in accordance with the table
below (e.g. to enter letter Z press the 9 key four times):
Key 1 2 3 4 5 6 7 8 9 0 . YES NO, C
Character 1 A,B, D,E, G,H, J, K, M, N, P,Q, T, U, W, X, 0, /, -, . Space Backspace
C,2 F, 3 I, 4 L, 5 O, 6 R, S, 7 V, 8 Y, Z, 9 #, %

Confirm the new drug name by pressing the ENTER key.

NOTES:
1. Entered character can be reset by means of the C or NO keys.
2. Old drug name can be restored by means of the PROG key until
new name is confirmed.

Default drug set


(code: 157)
This option restores default (manufacturer‘s) drug set.

Language set
(code: 337)
This option allows the language of the pump to be set.

Date and Time setting


(code: 637)
This option allows to set of date and time.

Parameter set
(code: 237)

Factory
SEP-10S SEP-12S SP-12S
Function name Enables/disables default Notes
Plus Plus Pro
VTBI programming of volume to be infused
* √ √ √
VOLUME OVER programming of VTBI over time
TIME - √ √ √
INFUSION RATE programming of infusion rate upper
LIMIT: XXXX ml/h limit
1500 ml/h √ √ √ 1,5
MANUAL BOLUS manual bolus infusion * √ √ √ 2
AUTOMATIC BOLUS delivery of preprogrammed bolus
volume * √ √ √ 2
BOLUS RATE programming of bolus rate
PROGRAMMING - √ √ √

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PUMP MANUAL
BOLUS RATE programming of bolus rate upper
LIMIT:XXXX ml/h limit
1500 ml/h √ √ √ 1
40, 80, 120 kPa programming occlusion pressure
level 40, 80, 120
X X √
for 50/60 and 100 ml syringes kPa
30, 60, 90 kPa –“–
RATE: mg (µg)/h programming of infusion rate in mass
units * X √ √
RATE: programming of infusion rate in
mg (µg)/kg/h (min) mg/kg/h;µg/kg/h; mg/kg/min; * X √ √
µg/kg/min
CALCULATION OF calculation of concentration from
CONCENTRATION entered drug mass and diluent - X √ √
volume
TOTAL VOLUME displaying of total infused volume
DISPLAY * √ √ √
AUTOSAVE saving of settings and total infused
volume after switching the pump off * √ √ √
DRUG NAME display of drug name
DISPLAY * √ √ √
TITRATION programming of infusion rate without
stopping the infusion * √ √ √
STANDBY programming of standby time - √ √ √
KEYPAD LOCK protection of the keypad against
accidental or unauthorized usage - √ √ √
QUIET MODE short beep accompanying any
keystroke - √ √ √
NO MAINS ALARM alarm on condition the pump is
AT POWER UP powered * √ √ √
up while not connected to the mains
KOR FUNCTION executing of KOR function * √ √ √
KOR RATE: programming of KOR rate 1, 3,
XX ml/h - √ √ √
4
DATE and TIME displaying of date and time
DISPLAY * √ √ √

* – enabled
- – disabled
√ – available
X – unavailable

NOTES:
1. To modify the value of parameter, press the PROG key, enter the new value using the numerical
keypad and confirm it by pressing the ENTER key.
2. These parameters are not displayed when both Manual and Automatic boluses disabled.
3. Parameter is not indicated when KOR FUNCTION disabled.
4. If parameter disabled, default KOR rate is 5.0 ml/h.
5. Does not affect infusion rates set in drug protocols.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 37


PUMP MANUAL
7. VISUAL AND AUDIBLE ALARM
SIGNALS
Alarm signals are issued by means of sound, flashing display
backlight and corresponding message displayed. Alarm signals
are cancelled by pressing the C key. Sound volume can be
adjusted with rotary switch (optional) on the bottom of the
pump.

Table 1 Troubleshooting Pump Alarm Messages

MESSAGE CAUSE CORRECTION CHECKING


Reconnect the pump to AC Connect the mains cable to the
The pump has been
power supply or press the pump. Switch on the pump and
NO MAINS disconnected from the AC
CANCEL key to silence the launch infusion. After few
Check power cord power supply and is
alarm and continue operation seconds disconnect the mains
operating on internal battery.
on internal battery. cable.

LOW BATTERY* Connect the pump to AC


Run the pump on battery until
(and BATTERY LED Battery charge low. power supply and charge the
alarm signal is generated.
flashing) internal battery.

The internal battery is Connect the pump to AC Run the pump on battery until it is
VERY LOW BATTERY depleted power supply. depleted completely.

Identify and remove the


Pressure in the extension set While infusion is in progress
cause of the blockage in the
OCCLUSION!!! and the syringe has reached
extension set, syringe or
block the extension line and wait
the alarm limit. until alarm is generated.
drive.
If the cause of stopping is an
The pump ceased its
occlusion, remove the cause
operation due to blockage in
of blockage and resume
the extension set, syringe or Use BD Plastipak 50 ml syringe.
infusion by pressing the
drive or if the syringe Pull out syringe plunger to the
OCCLUSION or END plunger has reached the end
START / STOP key.
value of 1 ml. Launch the infusion
When the cause of stopping
of its travel. It may happen and wait until alarm is generated.
is the syringe plunger
when syringe was not fully
reaching the end of its travel,
filled.
the syringe shall be replaced.
Use BD Plastipak 50 ml syringe.
Pull out syringe plunger to the
Replace the syringe or turn
SYRINGE EMPTY!* The syringe is empty.
the pump off.
value of 20 ml. Launch the
infusion and wait until syringe is
emptied.
In the setup menu switch on the
Infusion has been stopped Resume the infusion or press KOR FUNCTION. Launch the
Stop X.X ml
and not resumed within 2 the CANCEL key to silence infusion and after few seconds
KOR XX ml/h** min. the alarm. stop it. Wait until alarm is
generated.
In the setup menu switch on the
KOR FUNCTION. Set the
END OF INFUSION! The pump has reached the Replace the syringe or turn
Volume limit. Launch the infusion
KOR XX ml/h** end of infusion. the pump off.
and wait until preset volume limit
is infused.

38 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Table 1 Troubleshooting Pump Alarm Messages-continued

MESSAGE CAUSE CORRECTION CHECKING


In the setup menu switch on the
SYRINGE EMPTY! Replace the syringe or turn KOR FUNCTION. Launch the
The syringe is empty.
KOR XX ml/h** the pump off. infusion and wait until syringe is
emptied.

The pump is left for 2 min


ATTENTION! Switch on the pump and wait for 2
without starting the Press the CANCEL key.
2 min INACTIVE! min.
operation.
In the setup menu switch on the
STANDBY function. Launch
STANDBY TIME The preprogrammed standby
Press the CANCEL key. infusion, and after few seconds
ELAPSED time interval elapsed.
stop it. Set standby time to 3 min
and wait until it is elapsed.
Use BD Plastipak 50 ml syringe.
Pull out syringe plunger to the
The pump is nearing the end
X min. PREALARM! of infusion.
Press the CANCEL key. value of 20 ml. Launch the
infusion and wait until alarm is
generated.
Loaded syringe having a Load BD Plastipak 50 ml syringe.
ILLEGAL SYRINGE! diameter not complying with Slowly lift up the syringe barrel
Load the proper syringe.
Change SYRINGE! any syringe from the pump clamp until message is indicated
syringe library. on the display.
CLAMP The syringe barrel clamp has Close the clamp and resume While infusion is in progress lift
OPENED! been opened during infusion. the infusion. up the syringe barrel clamp.
Load syringe barrel without
plunger. Insert fixture between the
PLUNGER The syringe plunger has been Check the correctness of grippers to keep them in plunger
NOT FITTED! displaced during infusion. syringe position. inserted position. Launch infusion
and after few seconds pull the
fixture out of grippers.
Remove the pump from
ERROR: XX The pump has detected an service and have the pump
internal malfunction. checked by qualified
---------------------
(XX-error code)
personnel.

* - Audible signal accompanying these messages is an intermittent one.


** - The purpose of the function KOR (Keep Open Rate) is to continue infusion of very small amount of
drug after the end of infusion.

SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO 39


PUMP MANUAL
8. MAINTENANCE AND STORAGE

The pump has to be switched off and must be


unplugged from the line for cleaning.

Do not clean, disinfect, or sterilise any part of the device by


autoclaving or with ethylene oxide gas. Doing so may
damage the device and void the warranty. Only external
parts of the device should be disinfected.

Do not use the following chemicals on the device, as they


will damage the front panel: acetone, acetoaldehyde,
ammonia, benzene, hydroxytoluene, methylene, chloride,
and ozone.
Do not use cleaners containing n-alkyl, dimethyl,
ethylbenzyl, ammonium chloride unless they appear in the
list of recommended cleaners overleaf.

Keep the syringe pump clean and dry.

After cleaning, check for the absence of liquid in the mains


inlet. The presence of liquid can cause shortening of the
contacts. Clean the mains inlet using a dry pad of gauze
and only then reconnect the pump to the mains.

Cleaning Overview
The exterior of the device may be cleaned with a soft cloth,
sparingly dampened with any of the cleaners listed below. Do not
spray cleaners directly into the syringe mechanism, the area
where the power cord enters the device or the interface
connectors. Do not use hard instruments for cleaning. Follow
the manufacturer’s dilution instructions for concentrated cleaners.
Always clean/disinfect the device after each use. For a device that
has been in an Isolation Area, select those agents from the list
below that both clean and disinfect.

While the product design safeguards against fluid spillage, if fluid


enters the pump, contact your dealer or manufacturer’s servicing
department for assistance. This should be done immediately to
minimise any potential difficulties with the solutions pooling and
drying on the mechanism.

Recommended cleaners
Before using a cleaner on the pump, it should be tested on a
small area beforehand.
- A solution of 3% hydrogen peroxide
- Soapy water
- Ethyl alcohol

40 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Preventive Maintenance
The table below contains a schedule of basic maintenance tasks
that should be performed on the device. If the device cannot be
cleaned using the basic methods described earlier or components
are missing or damaged, discontinue use and notify the appropriate
authorised service personnel.

Check Action
Perform as required but recommended after every use
Housings Clean housing and front panel as recommended in the cleaning instructions in this section.
Check for cracks and large dents.
Labels Clean as recommended in the cleaning instructions. Check for scratches, cuts or
obliterated words.
Power cord Verify that the power cord is undamaged over the entire length of the cord and the
moulded plug.
Rear housing accessory Verify that there are no loose or missing parts and that connectors and accessories are
undamaged.
Battery Recharge by plugging into mains power outlet. Check that the MAINS LED is
illuminated during this time.
Perform as required but recommended every 24 months.
Entire device Schedule operational checkout by qualified biomedical personnel or authorised service
representative.

Battery Operation Overview


The device can be battery operated in emergency situations and for
temporary portable applications. When operating on battery the
Battery LED lights.

Battery Charging
The battery is charging whenever the device is plugged into mains
outlet, regardless of whether the device is on or off. If the pump is
not used for a long time, the battery should be charged at least
once in a 2 months.

In general, the more often a battery is discharged and recharged,


the sooner it will need to be replaced. Notify a authorised service
person for replacement. Batteries should only be replaced by
authorized service personnel.

Battery Disposal
Battery should be disposed of as outlined by the local country
regulation.

Storage
It is recommended that the device remain plugged in during
storage to maintain the battery at full charge. Do not store the
device with the key ON and the device unplugged.
When unpackaged, ensure the product is stored in a clean and dry

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PUMP MANUAL
(20-95%, RH, non-condensing) environment to safeguard against
prolonged exposure to dust and moisture. In conditions falling
outside the Environmental Operating Limits (see the Technical
Specifications Table in chapter 9), Viltechmeda recommends that
the device be repackaged in the original shipping materials.

Test routines
The test routines are designed to allow confirmation of many of
pump parameters, functions and calibration without requiring
internal inspection. Refer to Service Manual for a complete list of
test and calibration procedures.

Repair
The right to repair the pump or carry out periodical part
replacements is reserved only to the Manufacturer authorised service
representative.

The pump as well as its replaceable spare parts shall be disposed of


taking local legislation into consideration. Do not send back to the
manufacturer. None of the pump’s components does not pose
hazard to environment and can be safely disposed of in accordance
with hospital protocols.

Table 1 Pump part to be periodically replaced

Part Part Name Periodicity of Criterion for


Number Replacement* Replacement
B6640001 Battery 3–4 years Cordless work time has
diminished more than twice
(check at 25 oC)
B8123009 Cap 3–4 years Damages (cracks, etc.)
* - periodicity of replacement depends mainly on the frequency
of use for each part

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PUMP MANUAL
9. TECHNICAL SPECIFICATIONS
Description
Component
SEP-10S Plus SEP-12S Plus, SP-12S Pro

Syringe sizes 10-100 ml of main brands;


5 ml – optional.

Infusion rates 0.1 to 99.9 ml/h in 0.1 ml/h steps;


100 to 1500 ml/h in 1 ml/h steps.
Note:
Maximal infusion and Bolus rates:
– 200 ml/h for syringe 5 ml;
– 450 ml/h for syringe 10 ml;
– 750 ml/h for syringe 20 ml;
– 950 ml/h for syringe 30 ml;
– 1500 ml/h for syringes 50/60 ml and 100 ml.

Volumetric accuracy +/- 2% or +/- 0.1 ml/h (the greater of these values) – with approved
syringes

Mechanical accuracy +/- 1%

Volume To Be Infused (VTBI) 0.1 to 99.9 ml 0.1 ml steps;


100 to 999 ml in 1 ml steps;
unlimited volume.

Bolus rates 0; 10 to 1500 ml/h in 1 ml/h steps;

KOR (Keep Open Rate) rate 0.1 - 10.0 ml/h in 0.1 ml/h steps (or set rate if lower than KOR).

KOR volume 1.0 % of syringe volume.

Standby time 1 to 999 min in 1min steps.

Volume infused 0.1 to 99999 ml

Occlusion alarm pressure high – 120 kPa ± 25 kPa;


medium – 80 kPa ± 20 kPa ;
low – 40 kPa ± 15 kPa;

or (only for SP-12S Pro)

high – 90 kPa ± 20 kPa


medium – 60 kPa ± 15 kPa
low – 30 kPa ± 15 kPa

Medium and low levels for 50/60 ml and 100 ml syringes only.

Concentration 0.01 to 9.99 (µg)mg/ml in 0.01


(µg)mg/ml steps;
____________
10.0 to 99.9 (µg)mg/ml in 0.1
(µg)mg/ml steps;
100 to 999 (µg)mg/ml in 1
(µg)mg/ml steps.

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PUMP MANUAL
Infusion rate in mass units 0.01 to 9.99 (µg)mg/h,
(µg)mg/kg/h(min) in 0.01 (µg)mg/h,
(µg)mg/kg/h(min) steps;
____________ 10.0 to 99.9 (µg)mg/h,
(µg)mg/kg/h(min) in 0.1 (µg)mg/h,
(µg)mg/kg/h(min) steps;
100 to 999 (µg)mg/h,
(µg)mg/kg/h(min) in 1 (µg)mg/h,
(µg)mg/kg/h(min) steps;

Bolus doses 0.1 to 99.9 ml in 0.1 ml steps; 0.1 to 99.9 ml in 0.1 ml steps;

0.01 to 9.99 µg,mg,(µg)mg/kg in 0.01


µg,mg,(µg)mg/kg steps;
10.0 to 99.9 µg,mg,(µg)mg/kg in 0.1
µg,mg,(µg)mg/kg steps;
100 to 999 µg,mg,(µg)mg/kg in 1
µg,mg,(µg)mg/kg steps;
no automatic bolus.

Patient weight __________ 0.4 to 99.9 kg in 0.1 kg steps;


100 to 200 kg in 1 kg steps.

Mounting - table top operation


- universal pole clamp
- Draeger bar (optional)
- Mains splitter (optional)

AC power supply 220-230 VAC ±10%, 50/60 Hz, or


115 VAC (optional) ±10%, 50/60 Hz

External DC power supply 12 VDC

Battery:
Battery type NiMH, 9.6 V / 1300 mAh

Battery operation 8 h @ 5 ml/h

Battery charging time Up to 24 hours to 100% charge

Power consumption 10 VA (max).

Fuses
T80 mA/L250 V (for 220-230 VAC);
T160 mA/L250 V (for 115 VAC).

Protection against current leakage Type CF equipment

Protection against electrical shocks Class II

Protection against splashing liquid IPX4 (splashing water protected)

CE 0408 Council Directive 93/42/EEC (14 June 1993) concerning medical devices

Electrical safety and EMC IEC 60601-(1, 1-2, 2-24)

Maximum volume under single fault condition <0.5 ml

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PUMP MANUAL
Operating temperature range +5°C – +40°C

Transport and storage temperature -20°C – +40°C

Operating atmospheric pressure 60 kPa – 106 kPa

Permissible relative humidity 20 - 90%, no condensation

Memory retention For more than 10 years when not powered up.

Event log up to 2000 events

Infusion modes Continuous, Profile (optional in SEP-12S Plus, SP-12S Pro)

Use in ambulances Optional in SEP-10S Plus and SP-12S Pro

Interfaces RS 232 (optional in SEP-10S Plus)


Nursecall (optional)

Dimensions (WxHxD) 305 x 135 x 195 mm

Weight 2.6 kg

Transport In the original packaging

Volumetric Accuracy of the System


The pump, using the appropriate syringe (identified in
Chapter 2), maintains a volumetric accuracy with delivery errors
not exceeding ±2% for any one hour period over 72 hours at 5
ml/h.

Note that flow fluctuations can be caused by unusual conditions or


combinations of conditions that may involve, but are not limited
to, the following: fluid density, positive and negative pressure and
the environment. Flow fluctuations are most likely to occur when
the conditions mentioned above are exacerbated or when the
device is operated in conditions outside of its normal limits.

The accuracy figures as stated are based upon operation at a room


temperature of 22°C.

NOTE:
The all data shown is for the BD Plastipak 50 ml syringe with
BALTON, PPI/LL – 120 cm extension set

Startup Graph Description


The Startup Graph was developed in accordance with IEC 60601-
2-24.
The Startup data shown in the graph illustrates the startup
performance of the pump during the first 120 minutes of operation
with a sampling period of 30 seconds.

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PUMP MANUAL
A Startup graph of flow versus time illustrates initial stability with
time.
Even with the proper components and set up, the flow of any
manufacturer’s pump may be erratic during the 120-minute startup
period. Therefore, we have included the startup, or stabilisation
data. It should be noted that as the time interval over which
accuracy is measured is lengthened, all pumps show considerable
improvement in flow accuracy.
Startup Graph Example

How Trumpet Curve Graphs are Interpreted


The trumpet curve provides a graphical view of the maximum
deviation in flow rate from the programmed delivery rate for
specific segments of delivery time. The horizontal axis does not
represent elapsed delivery time, but rather acts as a graphical
reference for selecting specific observation time intervals. The
widest area of the trumpet curve (greatest deviation) reflects the
smallest sampling intervals or observation windows. As the sizes
of the sampling intervals increase (in minutes), the deviations in
flow from the programmed delivery rate are reduced as the
Trumpet Graph Example deviations are spread out over the longer periods of time. This
results in the narrowing of the trumpet curve giving a more
realistic representation of the device’s average flow rate accuracy
over longer intervals of time.

For example, if you were to look at the maximum and minimum


percentage error points corresponding to the 5-minute interval
point on the Observation Interval axis, you would be looking at the
average flow variance for any 5-minute period throughout the
infusion.

Similarly, if you were to look at the 60-minute interval point on


the Observation Interval axis, you would be looking at the average
flow variance for any 60-minute period throughout the infusion.

How Trumpet Curves Can Be Used


Trumpet curves can be important sources of information for the
medical professional who must decide whether a certain infusion
pump can be used with a particular drug. For example, when
delivering a drug with a short half-life, very small deviations in
flow over the course of an infusion would be desirable to ensure
that the deviations in plasma level also remained small. The
device’s ability to deliver very closely to the programmed rate
would ensure that the drug’s efficacy was being maintained. In this
example, the medical professional would be wise to select a device
whose trumpet curve indicated a small or narrow range of
deviations in flow rate.

46 SEP-10S PLUS, SEP-12S PLUS, SP-12S PRO


PUMP MANUAL
Startup and Trumpet Curves

Startup graph. BD Plastipak 50 ml @ 1 ml/h Startup graph. BD Plastipak 50 ml @ 5 ml/h

Trumpet graph. BD Plastipak 50 ml @ 1 ml/h Trumpet graph. BD Plastipak 50 ml @ 5 ml/h

Influences of Back Pressure at 5 ml/h


Startup graph. BD Plastipak 50 ml (+100 mmHg) Startup graph. BD Plastipak 50 ml (-100 mmHg)

Trumpet graph. BD Plastipak 50 ml (+100 mmHg) Trumpet graph. BD Plastipak 50 ml (-100 mmHg)

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PUMP MANUAL
Maximum Infusion Pressure Generated
The maximum infusion pressure prior to alarm activation is 145 kPa.

Alarm Delay at Occlusion

Time to Alarm activation (max)


Occlusion alarm
Rate
pressure level
low – 40 kPa ± 15 kPa; low – 30 kPa ± 15 kPa;
high – 120 kPa ± 25 kPa. high – 90 kPa ± 20 kPa.

Low 1 h 20 min 1h
1 ml/h
High 2h 1 h 40 min
Low 15 min 10 min
5 ml/h
High 25 min 20 min

Bolus Volume at Occlusion

Rate Occlusion alarm pressure level Bolus volume (max)

Low 0.3 ml
5 ml/h
High 0.5 ml

Automatic Bolus volume accuracy


The information in the following table represents laboratory testing
conducted per Sub-Clause 50.106 of IEC 60601-2-24 Part 2.

Deviation
Set value
Mean Maximum positive Maximum negative

0.1 ml - 0.6 % + 2.0 % - 4.0 %

1 ml + 0.5 % + 1.2 % - 0.2 %

20 ml + 0.3 % + 1.4 % - 0.3 %

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10. GUIDANCE AND MANUFACTURER'S
DECLARATION ON ELECTROMAGNETIC
EMISSIONS

Electromagnetic Compatibility Statement


This statement and the information provided in the following
tables are required by IEC 60601-1-2:2001. The tables can be
used to identify what EMC (electromagnetic compatibility)
standards SEP-10S Plus, SEP-12S Plus, SP-12S Pro syringe
pumps (hereinafter – Syringe pump) were subjected to, the
minimum test level identified in the standard, the level that the
pump meets and general guidance on the EMC environment. The
pump is intended for use in the electromagnetic environment
specified in the following tables. As with most microprocessor-
based electronic products, syringe pump creates RF (radio
frequency) energy as a side effect of its internal functions.

Precautions should be taken to avoid exposing syringe pump to


powerful sources of electromagnetic radiation such as MRI
(magnetic resonance imaging) and ESU (electro-surgical
equipment).

Note that portable and mobile communications equipment such as


cell phones can affect MEDICAL ELECTRICAL EQUIPMENT
such as syringe pump.

The use of ACCESSORIES and cables other than those


specified in the Operator’s Manual may result in increased
EMISSIONS or decreased IMMUNITY of syringe pump.

Syringe pump should not be used adjacent to or stacked


with other equipment and if adjacent or stacked use is
necessary, syringe pump should be observed to verify
normal operation in the configuration in which it will be
used.

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Table 1 Guidance and manufacturer's declaration - electromagnetic emissions

Syringe pump is intended for use in the electromagnetic environment specified below. The customer or the user of
syringe pump should assure that it is used in such an environment.

Electromagnetic environment -
Emission test Compliance
guidance
RF emissions Group 1 Syringe pump uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions Class B Syringe pump is suitable for use in all


CISPR 11 establishments including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Harmonic emissions Class A
IEC 61000-3-2

Voltage fluctuations/flicker Complies


emissions
IEC 61000-3-3

Table 2 Guidance and manufacturer's declaration – electromagnetic immunity

Syringe pump is intended for use in the electromagnetic environment specified below. The customer or the user of
syringe pump should assure that it is used in such an environment.

IEC 60601 Compliance


Immunity test Electromagnetic environment - guidance
test level level
Electrostatic +/- 6 kV contact +/- 8 kV contact (1) Floors should be wood, concrete, or ceramic tile. If the
discharge (ESD) floors are covered with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
+/- 8 kV air +/- 15 kV air (1)
Electrical fast +/- 2 kV for power +/- 2 kV for power Mains power quality should be that of a typical
transient burst supply lines supply lines commercial or hospital environment.
IEC 61000-4-4
+/- 1kV for +/- 1kV for
input/output lines input/output lines
Surge +/- 1kV +/- 1kV Mains power quality should be that of a typical
IEC 61000-4-5 differential mode differential mode commercial or hospital environment.

+/- 2 kV common +/- 2 kV common


mode mode

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Table 2 Guidance and manufacturer's declaration – electromagnetic immunity – continued

Syringe pump is intended for use in the electromagnetic environment specified below. The customer or the user of
syringe pump should assure that it is used in such an environment.

IEC 60601 Compliance


Immunity test Electromagnetic environment - guidance
test level level
Voltage dips, short <5% UT (> 95% <5% UT (> 95% Mains power quality should be that of a typical
interruptions and dip in UT) for 0.5 dip in UT) for 0.5 commercial or hospital environment. If the user of the
voltage variations cycle cycle syringe pump requires continued operation during
on power supply power mains interruptions, it is recommended that the
input lines 40% UT (60% dip 40% UT (60% dip syringe pump be powered from an uninterruptible
IEC 61000-4-11 in UT) for 5 cycles in UT) for 5 cycles power supply or a battery.

70% UT (30%dip 70% UT (30%dip


in UT ) for 25 in UT ) for 25
cycles cycles

< 5% UT (>95% < 5% UT (>95% User should always have battery installed per
dip in UT ) for 5 dip in UT ) for 5 Operator’s Manual.
sec sec (2)
Power frequency 3 A/m 3 A/m Power frequency magnetic characteristic of a typical
(50/60 Hz) location in a typical commercial or hospital
magnetic field environment.
IEC 61000-4-8
400 A/m (1) The pump functions normally when exposed to power
frequency magnetic fields of 400 A/m.

Note 1: Syringe pump was designed to meet the requirements of EN 60601-1-2: 2001 and IEC 60601-2-24: 1998

Note 2: Pump automatically transfers to battery operation if there is a loss of main power.

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Table 3 Guidance and manufacturer's declaration - electromagnetic immunity - for
LIFE-SUPPORTING EQUIPMENT and SYSTEMS

Syringe pump is intended for use in the electromagnetic environment specified below. The customer or
the user of syringe pump should assure that it is used in such an environment.

Immunity test IEC 60601 Compliance Electromagnetic environment - guidance


test level level
Portable and mobile RF communications equipment should
be used no closer to any part of syringe pump, including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.

Recommended separation distance


Conducted RF 3 Vrms 3 Vrms d=1.17√P
150 KHz TO 80
IEC 61000-4-6 MHz outside ISM
bandsa

10 Vrms 10 Vrms d=1.2√P


150 kHz to 80 MHz
in ISM bandsb

Radiated RF 10 V/m 10 V/m d=1.2√P 80 MHz to 800 MHz


d=2.3√P 800 MHz to 2.5 GHz
IEC 61000-4-3 80 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).b

Field strengths from fixed RF transmitters, as determined


by an electromagnetic site survey, c should be less than the
compliance level in each frequency range.d

Interference may occur in the vicinity of equipment marked


with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these frequency ranges.

52
Table 3 Guidance and manufacturer's declaration - electromagnetic immunity - for LIFE-
SUPPORTING EQUIPMENT and SYSTEMS – continued

Syringe pump is intended for use in the electromagnetic environment specified below. The customer or the user of
syringe pump should assure that it is used in such an environment.

Immunity test IEC 60601 Compliance Electromagnetic environment - guidance


test level level

c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which syringe pump is used exceeds
the applicable RF compliance level above, syringe pump should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
syringe pump.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 4 Recommended separation distances between portable and mobile RF


communications equipment and syringe pump - for LIFE - SUPPORTING EQUIPMENT and
SYSTEMS

Syringe pump is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of syringe pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
syringe pump as recommended below, according to the maximum output power of the communications
equipment.
Rated Separation distance according to frequency of transmitter
maximum m
output power
of transmitter
150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
W outside ISM bands in ISM bands MHz GHz
d=1.17√P d=1.2√P d=1.2√P d=2.3√P

0.01 0.12 0.12 0.12 0.23

0.1 0.37 0.38 0.38 0.73

1 1.17 1.20 1.20 2.30

10 3.70 3.80 3.80 7.28

100 11.70 12.00 12.00 23.00

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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PUMP MANUAL
Table 4 Recommended separation distances between portable and mobile RF
communications equipment and syringe pump - for LIFE - SUPPORTING EQUIPMENT and
SYSTEMS – continued

Syringe pump is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of syringe pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
syringe pump as recommended below, according to the maximum output power of the communications
equipment.
Rated Separation distance according to frequency of transmitter
maximum m
output power
of transmitter
150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
W outside ISM bands in ISM bands MHz GHz
d=1.17√P d=1.2√P d=1.2√P d=2.3√P

NOTE 1 At 80 MHz and 800 MHz, the separation distance of the higher frequency range applies.

NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

54
11. DRAWING OF CABLES FOR
MULTIFUNCTIONAL CONNECTOR
(MFC)

Connection Data:
Ground (GND)
Normally Closed (NC)
Common (COM)
Normally Open (NO)

NOTE:
Use standard D Type - 9 Pin connectors.

* – the internal batteries are not fully charged when operating


from 12VDC. When operating pump from 12 VDC permanently
recharge the internal batteries (connect pump to the MAINS)
after 1 week of operation.

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12. WARRANTY AND SERVICE
INFORMATION

Warranty
The Manufacturer warrants that pump is free from defects in
material and workmanship under normal use and service for a
period of 12 months after the purchase date.
The Manufacturer or its authorised representative takes
obligation to carry out the warranty repair of the pump or to
replace the pump with an operational one in case the Manufacturer
or its authorised representative determines that the cause of the
pump’s failure was related to the manufacturing process.
If the customer finds a defect in the pump during the
Warranty period, he must report it and inform the Manufacturer or
its authorised representative within 30 days.
A pump sent for testing, repair or replacement shall be
submitted to the Manufacturer or its authorised representative in its
original or equivalent packaging. The pump is sent for repair and
back at customer expense.
If no defect is found during testing, the Manufacturer or its
authorised representative reserves the right to submit the invoice to
the customer for the work carried out.
This Warranty is not applicable to pumps with damaged seal
or when failure was caused by violations of requirements of this
Operation Manual, by mains voltage non-conformity to the
requirements of IEC, by spills of liquids, by mechanical damages
caused by shocks or a pump being dropped, by pump damages
caused during transportation, or when packaging is damaged.

Service Information
For service and repair contact manufacturer:
Viltechmeda, 125 Kalvariju Str., 08221 Vilnius, Lithuania.
Tel.: (+370 5) 2776 745, 2737 508, 2737 506
Fax: (+370 5) 2763 867
E-mail: [email protected]

Shipping costs for all units returned to Viltechmeda shall be paid


for by the customer. The unit must be packed in its original
container or in another Viltechmeda approved container that will
provide adequate protection during shipment. To ensure prompt
return, a Viltechmeda’s authorised dealer must be notified before
shipping any unit for repair.
When calling for service, please be prepared to provide model and
serial number of the unit. A brief written description of the
problem should be attached to the instrument when it is returned
for service.
Viltechmeda will not be responsible for unauthorised returns or for
units damaged in shipment due to improper packing.

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13. ACCESSORIES
Description Part Number

Headboard/footboard mounting
B6302003
clamp

Clamp for mounting in ambulance


cars, required by EN B6090003
1789:1999+A1:2003

RS 232 cable B6650007

12VDC cable B6650008

Mains splitter MS-04 B2087019

IV stand I-235

Clamp for Draeger bar mounting B6302019-01


Nurse Call cable B6650009

Model:

Serial No:

Delivery date:

Quality inspector:

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