Syramed µSP6000 User Manual

Displays and Control Elements 2 16

4 1

6

3

15

7

11

8 17 5 14

9

12

10

13

Syramed® µSP6000 Chroma Front view

Index Numbers 1

Door latch

10

DATA display

2

Syringe clamp

11

On / Off & Standby key

3

Drive head

12

Rate keys

4

Syringe

13

DATA keys

5

„II“-key [5, SELECT]

14

Alarm indicator

6

LCD window

15

Door

7

Start / Stop key

16

Carrying handle

8

„I“-key [8, ESC]

17

Power and running indicators (see also page 55)

9

RATE display

Table of Contents 1

Introduction ... 4 1.1

Abbreviations ... 4

1.2

General information ... 5

1.3

General information, Contraindications ... 5

1.4

Cleaning and Disinfections ... 7

1.5

Key to symbols ... 8

1.6

Power and running indicators: ... 8

2

Specifications:... 9

3

Operation ... 10 3.1

General remarks ... 10

3.1.1

Basic concept of navigation: ...11

3.1.2

Setting of paramters: ...12

3.2

Preparing the pump for infusion... 13

3.2.1

Installation Information ...13

3.2.2

Inserting the syringe and choosing the drug ...14

3.3

Starting the Infusion ... 15

3.3.1

Menu controlled selection of infusion modes ...15

3.3.2

Individual program - Set up of rate and VTBI ...16

3.3.3

Time over Volume function ...16

3.3.4

Choosing a drug from the drug library ...17

3.3.5

Rate calculation using drug concentration and patient weight ...19

3.3.6

Special Infusion modes ...22

3.3.7

PCA / EPCA Mode ...23

3.3.7.1

Setting up the pump in PCA mode ... 24

3.3.7.2

Options while pump is running in PCA Mode ... 28

3.3.8

3.4

TCI Mode ...28

3.3.8.1

General information ... 28

3.3.8.2

Entering the infusion parameter ... 29

3.3.8.3

Functions while the pump is running in TCI mode... 32

3.3.8.4

Stopping the TCI infusion ... 34

During infusion ... 34

3.4.1

Display options in LCD – Help Menu ...34

3.4.2

Dynamic Rate Change ...35

3.4.3

How to Change the syringe and continue with infusion ...35

3.4.4

Reset the Volume infused ...35

3.4.5

Infusing a Bolus ...36

3.4.5.1

Manual Bolus ... 36

3.4.5.2

3.5

Stopping the Infusion ... 38

3.5.1

4

Automatic Bolus ... 36

Standby Mode ...39

3.6

Keep – Vein - Open (KVO) – Rate ... 39

3.7

Setting the occlusion limit ... 39

3.8

Options for external connections to the pump ... 40

3.9

Accessories and consumables ... 41

3.10

Using pump in parallel or multiple infusions ... 41

The Alarm System ... 42 4.1

Alarm indicators ... 42

4.2

Alarm causes ... 42

4.3

Cancelling the Alarm condition ... 43

4.4

Battery alarm ... 43

4.5

Occlusion Alarm ... 44

4.6

Nurse Call System ... 45

4.7

Near end of syringe alarm ... 45

4.8

Clutch Open Alarm ... 45

4.9

Internal Alarm ... 46

5

Risks and Side effects ... 46

6

Warranty ... 46

7

Trumpet curves ... 47 7.1

The significance of trumpet graphs in clinical practice ... 47

7.2

Typical trumpet curves of the Syramed® µSP6000 ... 48

8

EMC Behaviour ... 49

9

Maintenance ... 52 9.1 Scope and schedule of safety checks of the Syramed® µSP6000 Chroma syringe pump 53 9.2

Repairs ... 54

10 History ... 54

1 Introduction Dear Customer Congratulations, you have chosen a pump from arcomed ag. For optimum performance and safety, please read these instructions carefully before using the equipment. The pump must be taken in operation only after reading this user manual.

The pump must be taken in operation only after reading this user manual. About this user manual This device is equipped with a powerful software application which allows multiple combinations of, and modification to, all available functions according to your particular needs. To ensure this user manual is easily understood, we have not shown all possible configurations. For further information contact the official distributor in your country or the Customer Service Department in Switzerland. (Address, see chapter 1.5) Numbers in squared brackets refer to the illustrations of front and rear views shown in the beginning and of the end of this manual.

1.1 Abbreviations Relevant abbreviations which are used in this manual and/or in the menu of the pump, are listed here: Abbreviation

Text

CE

Concentration effect

CET

Concentration effect target

CP

Concentration plasma

CPT

Concentration plasma target

KOR

Keep open rate

KVO

Keep vein open

PCA

Patient controlled analgesia

PCEA

Patient controlled epidural analgesia

TCI

Target controlled infusion

TIVA

Total intravenous anaesthesia

TOV

Time over volume

TTBI

Time to be infused

VTBI

Volume to be infused

„II“-key [5, SELECT]

Select key on touch screen or indicated key (normally II key), allows to confirm a selection

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

4

ESC

Escape key on touch screen or indicated key (normally I key), allows exiting a menu or cancelling a selection Also used for short cuts.

1.2 General information The Syramed® µSP6000 Chroma is a syringe pump for medical application. To assure highest standards in quality and user-friendliness latest technology in R&D and production are used. This microprocessor-controlled syringe pump operates by pumping the infusate in the syringe using a controlled single action-pumping stroke. The sterility of the infusate is not affected. The pump is designed to infuse drugs or other infusates into the patient by controlled means under pressure. The pump can be used in both stationary and transportable applications due to a long battery life span up to 10 hours of duration. Warning: It is forbidden to use Syramed® µSP6000 Chroma for enteral application. To be informed about technical changes and incidents related to this device, please consult the arcomed Homepage under www.arcomed.com once a year. Due to the limited volume of syringes the infusion of blood or blood products with a syringe pump is not advisable. For such applications where high infusion volumes or speeds are required it is recommended to use volumetric infusion pumps such as the arcomed models Volumed® µVP7000 or Volumed® µVP50xx. NOTE: Physical parameters may introduce significant short-term variations at very low rates and volumes. It is therefore not recommended to operate the pump at very low infusion rates and volumes unless short-term variations are clinically irrelevant. The Syramed® µSP6000 Chroma is a medical device and meets the Medical Device Directive (MDD) requirements of the EC Guideline 93/42 EEC and is marked CE 0123 (TUV Süd PS Munich, Germany). The manufacturer according to MDD is arcomed ag, (address, see chapter 1.5) Classification according to MDD: IIb. The Syramed® µSP6000 Chroma may be operated only on mains power installed to DIN VDE 0100-710:2002-11 or the appropriate national standards. Mobile telephones should not be used anywhere near this equipment. If 3 pole mains cables are used the earth is only a functional earth.

1.3 General information, Contraindications The Syramed® µSP6000 Chroma syringe pump may only be used by trained staff. Attention should be paid to all security measures and issues as stated in the user manual: Warning: The Syramed® µSP6000 must not be used for patients, which are generally contra indicated to intravenous application of medicine. Warning: The Syramed® µSP6000 Chroma is a multifunctional infusion device which can be operated in various functional modes. It is only allowed that the user is GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

5

applying a functional mode where he is aware of risks and side effects. In uncertainties always the ESC button can be pressed and the input of parameters can be cancelled. This allows to switch directly to the individual mode. -

Check the pump and accompanying accessories for damage when unpacking and anytime when the device is in use. The pump must not be operated if damaged. Should the pump be damaged contact our Service Department.

-

The correct function of the pump can only be guaranteed if the pump is used with the specified infusions devices. If you want to use any other syringes, please get into contact with your arcomed distributor.

-

The Syramed® µSP6000 Chroma should normally be operated from a mains power supply. The internal batteries will automatically operate the pump in the event of a power failure.

-

For safety reasons the pump continuously monitors the keys and will trigger an internal alarm if any one of the keys is pressed by more than 60 sec or 3 keys are pressed together at the same time.

Warning: The pump continuously checks its hardware and internal functions and might stop and trigger an alarm if problems are detected. The user has to assure that for critical infusions a replacement pump is available to continue the infusion. It is the responsibility of nursing staff to station a replacement infusion pump near the patient if a temporary failure of the pump would create a not acceptable risk for the patient. Warning: The patient is not allowed to be in a water tub, take a bath or similar whilst connected to the pump. -

If the pump is operated in an area with strong vibrations the continuous flow might be interrupted. Small boluses of up to 50 µl may be given to the patient. The average rate of the pump is not influenced by that.

-

Do not operate this pump in an environment with high levels of electromagnetic radiation such as MRT. Portable and mobile RF communication equipment can affect medical equipment unless used with the arcomed Unique MRI Shield. Refer to the instructions and setup guidelines of the Unique MRI Shield manual. Mobile telephones may never be used anywhere near the pump. For additional information also see chapter 8.

-

This pump is not designed for use in areas where there is an explosion hazard. Environmental requirements as per IEC601-1-2 must be observed. For further information contact the official distributor in your country or the Customer Service Department in Switzerland (address see chapter 1.5)

-

Every 24 months a safety check needs to be done. For further information consult chapter 9.

-

The user must always verify that the set rate does not exceed the maximum flow capability of the catheter or the canola.

It is the responsibility of the nursing staff to deploy a replacement unit near the patient if a temporary shutdown of the infusion due to a defect of the infusion pump should lead to an unacceptable risk of the patient. GA-6000C-4L-E-0318 6 -

© 2018 by arcomed ag, Switzerland

-

Using syringes or connecting accessories that have not been tested and released by arcomed ag for the use with this pump can harm patients, users and other people and therefore is not allowed.

-

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

-

Immersing the pump in liquids is prohibited.

The expected life time of infusion devices is approximately 10 years.

1.4 Cleaning and Disinfections Warning: The pump must be switched off and disconnected from the mains power supply before cleaning and disinfecting. The pump must be kept clean and dry. Remove any spillage immediately. The pump must not be placed in an autoclave. Fogging is permitted. Make sure there’s no moist before taking the pump into operation. It is not allowed to disinfect the pump by means of UV irradiation! Wipe over with a cloth, which has been damped slightly with an alcohol-based disinfectant, cleans the unit. Take care when cleaning that no liquid enters the inside of the pump case. Wait at least 30 seconds after disinfections before switching the pump on. Use only disinfectants that are compliant with: ABS, POM, Polyamide, Stainless Steel, PVC, Aluminium, Silicone, (Please check with your supplier of disinfectant). Disinfections, methylated Spirits and Alcohol with a concentration of more than 80 percent are not allowed. Damages caused by misuse of cleaning agents are not covered by warranty. Please check the user manual that comes with the disinfection agent to find out about the correct application (residence time, dilution) Extra care must be exercised when cleaning the arm, located on the Drive-Head [3]. This arm must not be manually or physically pushed downwards when cleaning the pump. Contact between the cleaning agent and skin, eyes, mouth, or other body openings must be avoided. In such a case the affected parts must be cleaned with a lot of clear water. A doctor should be consulted in every case.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

7

1.5 Key to symbols The pictograms and symbols shown on the reverse of the pump have the following meanings or functions: Device of Type CF (Cardiac Float), defibrillator proof

Connection to automatic nurse call station

Electrical safety class 2 (double Insulation)

Declaration of conformity

IP32 protection against ingress of liquids and objects

Consult user manual before using the pump!

Connection for doctor key (only PCA)

Manufacturer address: Althardstrasse 150, CH 8105 Regensdorf, Switzerland. Phone.: + 41 (0) 43 388 90 30 Fax. +41 (0)43 388 90 40 Connection for optional 12-15 V AC/DC supply

Dispose old pumps according to the national guidelines. In particular printed circuit boards, batteries and the piezo-plates (containing lead oxide) of the air detection device must be disposed off in an environmentally friendly manner or returned to the manufacturer.

1.6 Power and running indicators: The window below the „ON/OFF“ key is used to indicate the following states: Pump infusing

If on: Pump on Mains operation Else Pump on battery operation

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

Furthermore the LCD displays the following: Pump stopped Pump infusing

8

2 Specifications: Classification:

IIb

Flow rate range:

0 – bis 1500 ml/h

Flow rate increments:

0.1 ml/h, optional 0.01 ml/h

Volume range:

0 - 999 ml

Volume increments:

0.1 ml, optional 0.01 ml

Syringe sizes

5, 10, 20, 30, 50, 60ml (automatic detection of size)

Syringe types:

BBraun Omnifix, Perfusor, BD Plastipak, Codan, Dispomed, Fresenius Injectomat, Terumo, IMI Syramed, Sherwood Monoject, All Pro, Terumo;

Precision:

+/- 3%

Syringe empty pre alarm:

3 min, adjustable

Bolus volume after occlusion:

automatic bolus reduction

Response time in case of occlusion:

depending on rate, pressure limit, syringe and syringe line

Maximum infusion pressure:

1.3 – 1.5 bar (depending on configuration)

Bolus rate, Prime rate (Purge):

1500 ml/h (50/60 ml syringe), adjustable

Alarm pressure limit (pressure sensor):

0 - 999 mbar / (adjustable also to mmHg scale)

KVO Rate:

0.3 ml/h, adjustable

Over infusion in case of error (Electr./Mech. error): max. 1.5 ml Resolution of pressure sensor:

10 mbar (adjustable also to mmHg scale)

Number of events saved:

1500 (resist in memory after pump is turned off

Battery operation time (2.15Ah):

3 - 12 h, depending on rate and mode

Charging time:

10 h

Mains supply voltage:

110 - 230 VAC, 50-60 Hz

External power supply (optional):

12-15V AC/DC

Input power:

8.5 VA / 80 mA

Mains fuse:

500 mAT/IEC127/III/SEV 1064

Electrical safety class:

II (double insulation)

Protection against ingress of liquids and objects:

IP32

Leakage current:

< 40 µA

Radio interference:

CE-Class B

Nurse call, potential-free

24 V/ 0.2 A

Classification:

CF (cardiac floating), defibrillator proof

Dimensions:

(W x H x D) 245 mm x 90 mm x 180 mm

Housing:

ABS plastic, UL listed

Weight:

ca. 1980 g

Max. storage time (without charging):

3 months

Atmospheric pressure:

600 hpa – 1300 hpa

Permitted temperature range:

15°C - 35°C / 0°C- 40°C (operation/storage)

Permitted relative humidity:

20-90% (no vapour deposit)

Safety certification according to:

IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2 (EMV)

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

9

3 Operation 3.1 General remarks The figures in brackets refer to the illustrations of front and rear views shown in the beginning of this manual. Warning: Use only approved disposable syringes! (see also Chapter 3.9) The performance characteristics depend on the system syringe / syringe extension line / pump. Only syringes may be used which correspond with the technical set up of the pump. The functional safety of the pump cannot be guaranteed if non-approved syringes are used. The safety of the patient may be compromised as a result. Warning: Only CE marked syringes with Luer Lock may be used with the pump. The pump may be configured for one or several brands of disposable syringe: Fresenius Injectomat, BD Plastipak, BBraun Perfusor, BBraun Omnifix, Nipro, Monoject, Terumo, Codan, Syrasend, Dispomed. Warning: Perfusor Syringe: if the Perfusor Syringe type is used at high pressure levels (500 mbar plus) with the Syramed Syringe pump, the user has to position the syringe plunger of the Perfusor syringe in the way that the rigid end of the plunger is directly positioned in front of the silver pressure sensor of the drive head of the pump. Otherwise longer delays in triggering an alarm are encountered at higher pressure levels. Alternatively other syringes types can be recommended by your arcomed representative. If you wish to use other syringes, please contact arcomed ag. Permitted syringe sizes are 5 ml, 10 ml, 20 ml, 30 ml and 50/60 ml. The size is identified automatically by the pump but has to be confirmed by the user. NOTE: In order to reduce the probability of choosing a wrong syringe it is recommended to enable only syringes that are actually in use in the hospital. Warning: During operation of the device, it could be that the device releases some warmness to the environment, which might influence the temperature of the fluid in the syringe. It is the users’ responsibility to ensure that the given fluid is administered to the patient in the temperature range according the guidelines from the fluid manufacturer/supplier. Be aware, that the audible alarm interval and initial pitch and sound level can be configured to the customers’ needs. Check if the current setting of the audible alarm is appropriated to the environment before connecting the pump to the patient. The Syramed® µSP6000 Chroma can be configured to the customer’s needs, please contact the arcomed representative for detailed information on you pumps configuration settings. GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

10

To avoid infusion of air, air filters can be attached to the extension line, as there is no obligation to have an air in line detector on syringe pumps. Further remarks: Disposable syringes are for single-use only. Single-use needles carry an infection hazard and must be disposed of in accordance with local guidelines. The patient must be disconnected during the loading and the removal or change of the syringe. The user must check that the pump and drive is not damaged and that the syringe plunger latch is in its home position before loading the syringe. In case of damage the Syramed® µSP6000 Chroma must not be used. The pump must not be placed more than 50 cm above the patient and negative pressures must be avoided. In case of multiple or parallel infusions high pressures or negative pressures can influence the accuracy of the rate (see also 3.13). Warning: In the case of strong negative pressure siphoning can occur and the plunger can be pulled with considerable forces. Therefore Syramed® µSP6000 has an anti-siphoning device (Syringe plunger latch) incorporated in the Drive head (see also chapter 4.8). It is important to know that these forces can also pull the plunger after the syringe latch is opened and the pump is not in control of the syringe.

3.1.1 Basic concept of navigation: The Syramed® µSP6000 Chroma is equipped with a large high definition color LCD display. A bottom line splits the LCD in two parts (see Figure 1). The upper part contains icons of functions and modes. The lower part contains the „II“-key [5, SELECT] button to confirm, the ESC button to get back and if available several scrolling arrows to the left or right might be available. This allows scrolling to the previous or next page of selection.

Upper Part

Bottom line Lower Part

Figure 1: Structur of LCD display

All functions can also be accessed by the key panel, using I, II and DATA keys. Data is entered / changed in the DATA and the RATE window.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

11

Further characteristics of the LCD: The large size of the display allows to display the vital values in large fonts so they can be read easily from a large distance The color display allows labelling drugs not only with names but also with colors (Med Marker). If consistent color labelling is used drugs or drug classes can be easily identified which is especially helpful if a large number of drugs are used on the same stack. Both text color and background color can be configured. Contact your pump administrator for customized drug labelling. Alarm messages are displayed with a RED background (Alert Scout). Alert (pre alarm state) can be displayed in colors (Alert Scout). Colored icons allow to easily and quickly find the application or selection desired. Values that can be changed in the RATE or DATA window are displayed in RED for easy identification of the setting parameters.

3.1.2 Setting of paramters: The Syramed® µSP6000 Chroma is equipped with the possibility of touch screen operation. -

-

-

The touch screen may be activated or disabled, depending on the options and settings of your pump The touch screen is a resistive technology and needs a certain amount of pressure to be activated. This increases the safety of the pump and avoids accidental touch presses e.g. by drips falling on the pump. On the other hand, the touch screen can also be operated with gloves. You might notice a very short delay between the press on the screen and the reaction of the pump. This is normal and increases the accuracy of the touch screen. The touch screen does only support single presses. Multi finger gestures are not supported by resistive technology. When swiping or pressing over the screen, no action will happen until the finger is removed. The pump will activate the last item selected. You will see most icons shortly changing its size when it’s pressed. If audible feedback is activated, a short beep also confirms a touch selection. For safety reasons some functions CAN NOT be accessed through the touch screen, e.g starting a bolus must be confirmed with a key on the panel. The Icon on the screen will indicate this with an arrow which key has to be activated. If the user still tries to access the function through the touch screen, a warning message will appear to indicate the key to be pressed. The pump can only be started or stopped with the START/STOP key on the panel for safety reasons. The stop and running icon on the screen will not start or stop the pump. The bottom line of the screen contains in most windows the navigation icons. In the main window the menu can be accessed with the MENU icon that will a list of applications that are available.

NOTE: The pump can be configured to hide certain functions. Therefore, depending to the configuration of your pump some functions might not be visible. Contact your administrator of pumps if functions needed are not visible. -

-

The pumps can be furthermore configured with additional icons at the bottom line of the main window, so called short cuts. These short cuts will bring you directly to a desired function or information with one press (see also Fig. 49). The short cuts might be different whether the pump is stopped or running or depending on the drug selected, e.g if functions are disabled or make no sense for a particular drug.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

12

Some of these icons might have interactive text, such as the current pressure or remaining time until the infusion/syringe is terminated. WARNING: Do not force the touch screen with extreme pressure or sharp items, this might damage the touch screen or even break the glass of the display. Watch out for unintended touch screen presses e.g. when you put the device loosely on a bed on transport. -

If you feel uncomfortable with touch screen operation, all functions can be accessed with the keys on the panel. -

-

Icons with the indication ‘I’ can also be accessed with the ‘I’ [8, ESC] on the panel. Icons with the indication ‘II’ can also be accessed with the key ‘II’ [5, SELECT] on the panel. If several selections are available, scroll between the selections with the up / down keys in the DATA window. This mode is indicated by to alternating ‘v’ and ‘^’ symbols in the DATA window. When changing the selection, the icon that is selected will show with a yellow underlay of the text. If several rows are available, continue pressing the up/down key until you reach the row desired. If several pages are available, continue pressing the up/down key until you reach the page desired. Once the desired icon is selection, you can confirm it with the „II“-key [5, SELECT], most of the time the „II“-key [5, SELECT]. Press ESC or Cancel, most of the time the „I“-key [8, ESC] to exit a selection or to get back to the main window.

3.2 Preparing the pump for infusion 3.2.1 Installation Information •

If the pump is to be operated with an infusion stand, care must be taken that the pump is not positioned more than 1.4m above the ground to ensure stability. Ideally use an "Arco Luxe" or "Arco Standard" infusion stand. If several pumps are mounted one above the other the maximum permitted height from the floor must be observed and measures taken to prevent instability.

•

The pump must not be fixed on poles with a diameter of more than 30 mm.

•

The pump may be fixed to the infusion stand by means of the pole clamp [22] on the rear of the unit. The screw must not be tightened by means of tools. Hand tighten the screw only, do not apply an excessive amount of force!

•

The Syramed® µSP6000 Chroma should not be installed more than 50 cm above the patient, to prevent negative pressure.

•

Permitted mounting: positioned on a flat horizontal surface or pole mounted on an infusion stand or rail mounted

•

Where possible mains power should be used. Plug the mains power cable into the connector socket [18] at the rear of the pump. The mains pictogram illuminates as soon as the mains supply is connected. The battery is charged automatically.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

13

3.2.2 Inserting the syringe and choosing the drug -

Draw up the infusate into the syringe using an aseptic technique and make sure there is sufficient excess volume to prime the extension set. Connect the extension set.

-

To turn on the pump, press the ON/OFF displays are illuminated.

key. An acoustic alarm is emitted and all

NOTE: During the ON/OFF cycle the pump emits an audible alarm and all alarm indicators, all status indicators and all LED displays (8888) are illuminated. Additionally the LCD displays the actual SW Version. If the audible sound is not emitted or any displays are defective, the pumps must not be used. -

Open the pump door [15] by releasing the Door latch [1]. Pull back the syringe clamp [2]. The Drive-Head [3] is powered automatically to extend fully to the right Make sure the syringe fixation is opened all the way.

-

Locate the syringe [4] in the pump with the Luer-lock connector to the left so that the ears of the syringe are positioned in the slot in the pump body. Push the syringe ears to the left so that they engage the front edge of the slot. If the patient is left of the pump, the syringe line (up to 2.5 mm diameter) can be placed in the groove in the door.

-

Controlled automatic loading of syringe: With the controlled automatic loading of the syringe, the drive head stays at its position all the way to the left after the door is closed. By pressing and holding „I“-key [8, ESC] the drive head moves to the syringe and locks the syringe plunger automatically. You can also load the syringe by pressing on the icon on the screen.

Figure 2: Request for loading the syringe

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

The LCD window [6] indicates the brand and size of syringe. Press „II“-key [5, SELECT], to confirm or „I“-key [8, ESC] to toggle between the types of syringes if the pump is configured for several syringe brands. When the correct syringe is chosen, confirm by pressing the “START/STOP” key or „II“-key [5, SELECT].

Warning: It is absolutely necessary to make sure the syringe size and syringe brand are confirmed correctly. GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

14

Figure 3: Menu for choosing the syringe -

If enabled: The LCD window will display "PRIME". Press and hold „II“-key [5, SELECT] to prime the extension set. For safety reasons connect the patient only after correct loading and purging of the syringe.

Figure 4: Request for priming the syringe (only if enabled)

Important: For safety reasons priming can only be done by pressing the „II“-key [5, SELECT] on the panel. Priming cannot be done by pressing the touch screen. Warning: After the procedure of loading the syringe is completed, the syringe pump can be connected to the patient.

3.3 Starting the Infusion After the pump was prepared as described earlier the infusion can be started. Several ways to enter the infusion parameter are possible.

3.3.1 Menu controlled selection of infusion modes To access to the overview of all menus, press MENU and chose either the touch screen to select directly the function of your choice or press the DATA keys as described in chapter 3.1.1.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

15

If you use only DATA keys, the menu has the following structure:

Figure 5: Menu options

3.3.2 Individual program - Set up of rate and VTBI To use the syringe pump in the simple individual mode, after priming rate in ml/h and VTBI can be entered by pressing the rate and DATA keys. Use arrow up keys to increase rate or VTBI, arrow down keys to decrease rate or VTBI. Each key press produces a single digit change. The least significant digit (smallest size) indicated is 0.1 ml/h if the rate does not exceed 1500 ml/h, otherwise the least significant digit indicated is 0.1 ml/h.

Figure 6: Pump infusing at a rate of 6.0 ml/h

If the full volume of the syringe is to be infused, make the patient connection and press the “START/STOP” key [7] to commence the infusion. If a specific volume is to be infused, the required volume in ml may be selected in the DATA window [10] by using the DATA keys (13) before starting the pump. If a VTBI is entered, the pump will show it below the infused ml. NOTE: To recognize a possible malfunction of display elements, it is necessary to verify that the displayed rate is changing in accordance with the input sequence.

3.3.3 Time over Volume function This function allows infusing a specific volume in a certain time. The calculation of the rate is done by the pump. To enter this function press „II“-key and scroll by pressing the DATA keys GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

16

to the menu point „TOV“. To confirm, press „II“-key. If the touch screen is enabled, you can directly press on the TOV icon without scrolling.

Figure 7: Menu for selecting the TOV function

The infusion time is entered in the rate window, the VTBI in the DATA window. As data is entered it is simultaneously displayed on the LCD. Once all values are entered, the „START/STOP” key may be pressed to start the infusion. (9 hours, 30 minutes are entered as 9.30 in the rate window.) NOTE: If the complete syringe shall be infused the VTBI must be left at “0”.

Figure 8: Input screen for infusion time (rate window) and VTBI (DATA window).

3.3.4 Choosing a drug from the drug library NOTE: The Syramed® µSP6000 Chroma has almost unlimited possibilities of configurations. As a pump administrator it’s highly recommend to KEEP IT SIMPLE. Many nurses are still used to simple ml/h infusions and before getting into complicated drug schemes make sure the staff is trained to master and most importantly not confuses e.g. drug dose calculation or TCI with classic ml/h infusions. The Syramed® µSP6000 Chroma also allows to have various configurations, typically a configuration for general ward, ICU or OR. With adequate startup drugs and short cuts the risk of wrong entries (drug dose errors) can be significantly reduced. Take advantage of these features where ever possible. Furthermore the Syramed® µSP6000 Chroma has a very powerfull interface combined with the Unique Concept. This allows not only to monitor the pumps and record the events but also to update automatically patient data or the latest drug mode libraries. GA-6000C-4L-E-0318 17 © 2018 by arcomed ag, Switzerland

Drug mode libraries allow nursing staff to deliver a certain drug without any rate calculation in ml/h. The drug library must be programmed into the pump previously. Choosing a drug will also load the drug specific infusion parameters like VTBI, rate, hardlimits and softlimits. To run the pump in this mode „II“-key is pressed after the syringe was loaded. Press the DATA keys to scroll to the menu point „Drug Classic ml/h“. If the touch screen is enabled, you can directly press on the Drug Classic ml/h icon without scrolling.

Figure 9: Menu for selecting the classic drug library.

By pressing „II“-key [5, SELECT] again, the mode is started. The saved drugs can be chosen with the DATA keys and are confirmed with „II“-key [5, SELECT]. The pump can also be set up to have drug classes or folders containing a sub set of drug mode selections. This allows having a better overview if the drug mode library contains many drug modes. To access a folder select it by pressing on the icon or scrolling until the folder is selected (yellow text underlay) and press „II“-key [5, SELECT]. To exit a folder or subclass continue scrolling passing the last or first drug in the class. To get back to the main window press ESC. This aborts the drug selection.

Figure 10: Choosing the drug Glucose from the internal drug library

Furthermore it is possible to run the pump in a high precision mode (“High Def Mode”), which allows entering rate and volume in steps of 0.01 ml/h (0.01 ml). The High Def Mode is activated by selecting a drug defined as high definition drug.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

18

Figure 11: High precision mode, Rate 1.25 ml/h, already infused: 3.78 ml

3.3.5 Rate calculation using drug concentration and patient weight The automatic rate calculation allows nursing staff to deliver drugs that are applied in dependence of drug concentration and patient weight (optional). The drugs have to be previously loaded into the pumps drug library. To run the pump in this mode „II“-key [5, SELECT] is pressed after the syringe was loaded. Press the DATA keys to scroll to the menu point „Drug Calculation“.

Figure 12: Selecting the Drug Calculation Mode

By pressing „II“-key [5, SELECT] again, the mode is started. The saved drugs can be chosen with the DATA keys and are confirmed with „II“-key [5, SELECT]. In general it is possible to set the rate independent from the patient weight in mg/h, µg/h and units/h, or depending on the patient weight in mg/kg/h, µg/kg/h, IU/kg/h, mg/kg/min, µg/kg/min IU/kg/min or mmol/h. It’s also possible to set the rate /24h.

GA-6000C-4L-E-0318 © 2018 by arcomed ag, Switzerland

19