SEP-10SPlus, SER -12S Plus and SP-12S Pro Operators Manual Rev 2.0 March 2007

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.

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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

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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

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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

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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.

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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

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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), intraarterial (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)

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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.

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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 SP12S Pro).

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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.

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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 60601-12.

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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

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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.

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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

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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

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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.

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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:

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

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

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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.

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