Infusomat Space and Accessories Instructions For Use Sw 686N June 2017

CONTENTS

Infusomat® Space Overview ...3 Symbols on Product...5 Patient Safety ...6 Menu Structure / Navigation ...11 Chapter 1 Operation...14 1.1 Start of Infusion ...14 1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time...17 1.3 Bolus Application ...18 1.4 Infusion Line Change and New Therapy Start...18 1.5 End of Infusion...20 1.6 Standby Mode...21

Chapter 2

Advanced Operations ...22 2.1 Status Request of Pump when Infusion is Running...22 2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset of Status Menu Data...22

Chapter 3

Special Functions*...23 3.1 Dosing Units and Dose Rate Calculation (Overview)...23 3.2 Dose Rate Calculation (Operation)...23 3.3 Drug Library...24 3.4 Patient Controlled Analgesia (PCA) (optional) ...27 3.5 Target Controlled Infusion (TCI) (optional)...28 3.6 Barcoding...35 3.7 Piggyback Function...35 3.8 Ramp and Taper Mode...38 3.9 Program Mode...40 3.10 Intermittent Mode...42 3.11 Dose Over Time ...45

Chapter 4 Chapter 5

Autoprogramming...47 Options ...51 5.1 Occlusion Pressure ...51 5.2 Upstream Occlusion Pressure ...52 5.3 Data Lock ...52 5.4 Bolus Rate...54 5.5 KVO-Mode ...54 5.6 Contrast / Display Light / Keypad Light...54 5.7 Alarm Volume ...54 5.8 Date / Time...54 5.9 Macro Mode...55 5.10 Language...55

Chapter 6

Alarms...56 6.1 Device Alarms...56 6.2 Pre-Alarms and Operating Alarms ...56 6.3 Reminder Alarms ...59 6.4 Alarm Hints ...60

*The availability of the listed features is depending on the configuration of the pump. **Technical Safety Check.

Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Ordering

Battery Operation and Maintenance...61 Start Up Graphs and Trumpet Curves ...63 Technical Data...64 Warranty / Training / TSC** / Service / Disinfecting / Disposal ...71 Instructions for Use Accessory...75 ...80

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INFUSOMAT SPACE® OVERVIEW

I N F U S O M AT ® S PA C E O V E R V I E W Arrow up and -down Scroll through menus, change setting of numbers from 0-9, answer Yes/No questions. Arrow left and -right Select data from a scale and switch between digits when numbers are entered. Open a function while pump is running or stopped with the left arrow key.

Press to reset single values to zero and switch back to the previous screen/menu level.

Press to open the pump door.

c

x

q Yellow LED: Green LED: Red LED: Blue LED:

Press to initiate bolus.

Pre-alarm, reminder alarm Infusing Operating or device alarm Initiating connection to wireless battery or Space Station

k

m

Open certain functions and press to confirm values/settings/alarms.

Press to initiate auto-programming orders when prompted.

Press to turn pump on/off.

B n o

f S Press to Start/Stop infusion.

Cover of Battery Compartment Before changing the battery, always disconnect the pump from the patient and switch off the device. To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange. A crank in order to open the pump door in case of emergency is attached to the inside of the battery compartment cover (for closer information see 1.4).

Port for drop sensor

Port P3 for future options

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Port P2 for power supply, SpaceStation, connection lead (12V), combi lead and further accessory leads (staff call, service)

INFUSOMAT® SPACE OVERVIEW Downstream pressure sensor

Air sensor

Opening lever Pump based free flow prevention safety clamp Pole clamp handle Pole clamp release button Pump slots

Green locking button

Yellow caution light

Line guide cover

Upstream pressure sensor

Fixaton of PoleClamp (Universal Clamp) Line up bar of pump with bar of PoleClamp and slide PoleClamp forward until locking mechanism clicks. To remove, press release button on frame, push handle down and pull PoleClamp backwards.

Transport A maximum of three pumps (Infusomat® Space or Perfusor® Space) plus one SpaceControl may be stacked together (in ambulance cars and helicopters only one pump). Avoid external mechanical influence. Locking Devices Together Line up the bar of the lower pump with the bar of the pump above and slide the lower pump backwards until the lock clicks and the green buttons are above each other. To disconnect, push green locking buttons of top pump device and slide bottom pump forward. Caution: Avoid external mechanical action. Pole Fixation Push the opening of PoleClamp against the vertical pole and lock the screw tightly. Unscrew to release. For vertical position push lever down and rotate either way until lever clicks into notch. Push lever for rotation. Caution: A maximum of three B. Braun Space pumps can be stacked together only in horizontal pump position when used with the PoleClamp SP.

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SYMBOLS ON PRODUCT

SYMBOLS ON PRODUCT Symbol

Explanation Mandatory action: see instruction for use. See accompanying documents. Type CF unit with defibrillation protection Protection class II device Symbol indicating separate collection for electrical and electronic equipment (2002/96/EC) only for valid for Europe, not applicable for US CE mark compliant to Directive 93/42/EEC Temperature Limit Moisture Limit Limitation of the atmospheric pressure Non-ionizing electromagnetic radiation General warning sign (e.g. Caution) Unsafe symbol (Do not use in MRI environment)

LOT

Batch number

SN

Serial number

REF

Catalogue number Manufacturer Date of manufacture

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PATIENT SAFETY

PAT I E N T S A F E T Y

w

Intended use

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration Read Instructions sets, and pump accessories. The system is intended for use on adults, pediatrics, for Use prior to use. and neonates for the intermittent or continuous delivery of parenteral and The infusion device enteral fluids through clinically accepted routes of administration. These routes should only be include, but are not limited to intravenous, irrigation/epidural, and enteral. The used by specially system is used for the delivery of medications indicated for infusion therapy trained staff. including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. Using TCI the scope of patients is: Weight [kg] Height [cm] Age [Yrs]

Minimum 30 130 16

Maximum 200 220 100

Some parameter sets are using the Lean Body Mass (LBM) to individualize the parameterization. The LBM calculation may furthermore restrict the scope of patients as it will not allow TCI for obese patients. Using TCI the scope of procedures is: • Propofol: Anaesthesia and Conscious Sedation • Remifentanil: Anaesthesia Qualified medical staff should decide how the device should be used based on its features and specifications. For more details, please read the Instructions for Use. Operation • The initial training of the Infusomat® Space is to be performed by B. Braun sales personnel or other authorized persons. After each software update, the user is required to inform himself about the changes to the device and accessories in the instructions for use. w Caution: Ensure the unit is properly positioned and secured. Do not position 4 pump unit above patient or in a position where a patient could come to harm, should the pump fall.

• Prior to administration, visibly inspect the pump for damage, missing parts or contamination and check audible and visible alarms during selftest. 6

PATIENT SAFETY

• Not be used adjacent and stacked with other equipment except B. Braun Space devices. • Only connect to patient once the line has been correctly inserted and completley primed. Interrupt connection during line change to prevent incorrect dose delivery. • During priming and bolusing the pressure limits are set to the maximum level. • Select infusion line/catheter suitable for use with the intended medical application. w Caution: Position the infusion line free of kinks. 4

• Recommended change of disposable every 96 h (or as per national hygiene regulations). • Installation in medically used rooms must comply with the appropriate regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national specifications and deviations. w Caution: Operate the pump at least 25 cm from flammable anaesthetics to 4

prevent explosion. • Compare the displayed value with the entered value prior to starting infusion. • If staff call is used we recommend checking the equipment once after connecting the pump. • Protect the device and the power supply against moisture. • If the pump falls down or is exposed to force, it must be checked by the service department. • The displayed data must always be checked by the user prior to making further medical decisions. • During mobile use (homecare, patient transport inside and outside the hospital): Make sure the device is securely fixed and positioned. Positioning changes and severe shock can lead to minor changes in the delivery accuracy and/or unintentional bolus administration. • A supplemental patient monitoring must be carried out if life-saving medication is performed. • The air detector cannot detect air diffusing in the following components: three-way stopcocks, infusion adapters and further lines placed between pump and patient. • In case high potent drugs are given be sure to have a second infusion pump for that drug at hand. The therapy documentation should be suitable to continue the therapy at the second infusion pump. • Independant of the soft limits the selected values have to be the medically correct ones for the given patient. 7

PATIENT SAFETY

• In case values relevant for the dose rate calculation are changing always the flow rate will be updated and the dose rate will be fix. • Consider startup characteristics before using low infusion rates (0.1ml/h) with critical drugs. Enteral Nutrition The Infusomat® Space may be used for enteral nutrition. Do not use enteral fluids for intravenous infusion as this may harm your patient. For this reason only use disposables dedicated and labeled for enteral nutrition. Transfusion The Infusomat® Space may be used for blood transfusion, too. For this therapy only use disposables dedicated and labelled for transfusion. Other components • Use only pressure-proof and compatible disposable items (min. 2 bar/ 1500 mm Hg) to avoid influencing performance data - which would result in impairing patient safety. • Where several infusion lines are connected on one single vascular access, the possibility of the lines exerting a mutual influence over each other cannot be excluded. • Refer to respective manufacturer’s information for possible incompatibilities of equipment with respect to drugs. • Use only compatible combinations of equipment, accessories, working parts and disposables with luer lock connectors. • Connected electrical equipment must comply with the relevant IEC/ENspecifications (e.g. IEC/EN 60950 for data-processing equipment). The user/operator is responsible for the system configuration if additional equipment is connected. The international standard IEC/EN 60601-1-1 has to be taken into account. Safety Standards Infusomat® Space satisfies all safety standards for medical electrical devices in compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24. • The EMC-limits (electro-magnetic compatibility) according to IEC 60601-1-2:2007 and IEC 60601-2-24: 2012 are maintained. If the equipment is operated in the vicinity of other equipment which may cause high levels of interference (e.g. HF surgical equipment, nuclear spin tomography units, mobile telephones etc.) may be disturbed. Maintain the protective distances recommended by the manufacturers of these devices.

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• The Infusomat® Space fulfils the applicable requirements of EN 13718 to be used in the air, on the water and in difficult terrain. During transport the Infusomat® Space needs to be fixed on a suitable restraint system by means

PATIENT SAFETY

of SpaceStation or Pole Clamp SP. When stored under temperature conditions beyond the defined operating conditions the Infusomat® Space needs to remain under room temperature at least one hour before usage. • As there is no dedicated norm existing for enteral feeding pumps the safety features of Infusomat Space are also for enteral nutrition according to the a.m. norms. Safety instructions for using PCA • In case the demand button is used with SpaceStation the PCA pump has to be placed in the lowest slot of the lowest SpaceStation. • Access to the pump settings can be prohibited by DataLock 3. The code for DataLock level 3 should differ from the one for levels 1 and 2 in case the pump is only allowed to be used by pain management professionals. • When ending PCA and starting it again the therapy data are set to default values. • Using the demand button also the patient is a permitted user. With the demand button only a PCA-bolus can be requested. This is limited to predefined doses by drug list and pump settings. Safety instructions for using TCI • TCI should only be performed by experienced anaesthetists being familiar with the principles of TCI and properly trained in using the present device. • The use of TCI with B. Braun Space does not limit the responsibility of the anaesthetist for administration of drugs. They need to be fully aware of the available literature for any parameter set used in association with a drug and need to refer to the prescribed information for rate and dosing limits. • Pharmacokinetic and pharmacodynamic interactions among anaesthetic drugs are known, but are not taken into account into the calculation of the plasma and effect site concentrations. They have to be taken into account by the user. • In particular, the user must be aware that starting the TCI will result in the automatic infusion of a pre-calculated bolus dose followed by an infusion to achieve the selected target concentration. • It is essential that the user verifies that the patient characteristics and the selected target concentration as well as the resulting dosages conform to the prescribing information of the relevant country. • B. Braun has verified the accuracy of the mathematical model implementation, the usability as well as pump delivery accuracy. • While using TCI an appropriate patient monitoring is mandatory. • Take care of using the right dilution/concentration of the drug and make sure the right dilution is selected at the pump. 9

PATIENT SAFETY

• Never administer Propofol or Remifentanil by a second infusion as long as you use TCI. • It is possible to completely switch off the TCI mode to avoid the use of TCI accidentally. • By using Infusomat® Space a change of drug concentration will not be possible within the same therapy.

Safety Instructions for using Pole Clamp 1. Line pump up with the Pole Clamp guide rails. 2. Slide pump fully into place onto the guide rails. 3. An audible “Click” should heard. 4. Test the pump is secure.

W The pump ist now securely attached to Pole Clamp. • Do not lean on the pump when attached to the Pole Clamp. • Do not position the pump unit above the patient.

Underside view Clamp grids

W • DO NOT use any Pole Clamp that shows signs of damage. • DO NOT use Pole Clamp with missing clamp grids.

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MENU STRUCTURE / NAVIGATION

MENU STRUCTURE / NAVIGATION Cutline o x f s b n

On/Off button Door open button Start/Stop button Bolus button

C Clear button K OK button Q Keypad with arrow up, -down, -left, -right button

m Connection button All display screen shots are examples and may be different when related to an individual patient and individualized therapy. Display

Meaning At the top of the screen the last therapy is indicated. Yes/No question can be answered by pressing u for yes or d for no.

Parameters which can be changed (e.g. rate in ml/h) are opened with l or k. When editing parameters, switch digits/levels using l r. White background indicates current digit/ level. Use u or d to change current setting. Help text on the bottom/top of the screen indicates options how to proceed (e.g. confirm rate with k, start infusion with f s or clear rate by pressing c). Typical display during infusion: Battery Connection to SpaceCom status in SpaceStation Mains connection

Set pressure limit and current pressure Therapy profile Active VTBI- or time preselection Scrolling arrows indicate pump is infusing Set rate can be opened with l

Unit of drug application Total volume infused. Alternatively the intermediate volume can be displayed. Remaining time Remaining VTBI

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MENU STRUCTURE / NAVIGATION

Display

Meaning All status information is available in the bottom line of the display. The desired information can be selected by using d u and will be displayed permanently thereafter (e. g. drug long name, current system pressure etc.).

b n has been pressed while the pump is infusing. Start manual bolus at 1200 ml/h by pressing k (see top of display) or proceed to set bolus limit with l (see bottom of display).

This hint pops up if a user tries to edit or change a parameter by pressing l when that parameter is unable to be changed.

Set pressure level with l or r and confirm by pressing k. Cancel to edit pressure by using c.

Pre-alarms are indicated by a message on the display (e.g. “VTBI near end”), an audible tone and the yellow LED is constantly on. To confirm a pre-alarm press k. In case of an operating alarm (e.g. "VTBI infused") the infusion stops, an audible tone sounds and the red LED flashes. Confirm alarm by using k. Confirming does not activate an acoustic feedback.

Press and hold o for 3 sec to turn pump off. A white bar stretches from left to right and counts down the 3 sec. As long there is an infusion line inserted the pump will not turn off but will use standby.

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MENU STRUCTURE / NAVIGATION

Start Up Menu

Main Menu

Special Functions

Options Menu

Status Menu

Line selection

Dose

Dose Rate Calculation

Occlusion Pressure

Intermediate volume

Prime ?

Concentration

Drug Library

Data Lock

Intermediate amount

Use last therapy ?

Weight

Change-over from continuous mode to PCA

Bolus Rate

Intermediate time

Use drug library ?

Rate

KVOMode

Total volume

Use dose rate calculation ?

VTBI

Contrast

Total amount

Time

Display Light

Total time

Special Functions

Keypad Light

Line

Options

Alarm Volume

Battery capacity

Status

Date

WLan

Time

Version

Macro Mode

Drug info

In Dose Mode: Display of flow rate in large scale

Language

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OPERATION Chapter 1

OPERATION 1.1 Start of Infusion • Ensure that the pump is properly installed. Check the equipment for completeness and damages. Do not attach the infusion bottle below the pump level. • Put the spike vertically into the infusion bottle. Fill the bottom part of the drop chamber by max. 2/3. w Caution: Close the roller clamp before inserting the IV line and do not 4 connect to patient until properly loaded and primed.

• If the device is connected to the mains, the display indicates the battery status, the mains connection symbol and the last therapy. • Press o to switch on the device. Observe the automatic self-test: The message “Self-test active” and the software version are displayed, two audible tones sound and all three LEDs (yellow, green/red and blue) flash once. Information about the power supply (mains or battery operation) and the set pressure level are indicated. In addition, the line type appears at first (provided that the line is already inserted). Then, the accumulated air volume and the max. size of air bubbles is indicated which is triggering the air alarm of the device. The pump offers the possibility to load up to four languages into the pump (depending on the number of the language specific characters), among which the user can choose during the operation of the pump. During the first ever start-up of the device, the user is requested to select the languages and to mark them with l. After that, the selection has to be confirmed by choosing the last menu item at the bottom of the list and pressing k. Then the desired language must be selected with t and confirmed with k. Answer the following question with d in order to activate the selected language. • Press c to start the direct entry of therapy parameters, or press x and u to open the pump door in order to continue with inserting the line. w Caution: Close the roller clamp before inserting the IV line and do not 4 connect to patient until properly loaded and primed.

Caution: You may only insert the line while the device is switched on and the line guide element is inserted. Otherwise, there is the danger of freeflow. Pay attention to keep the roller clamp closed before inserting the infusion line especially at a temperature scale of 10 - 15 °C. Never leave the pump unattended when inserting the tube. Caution: Inserting different lines into the pump is identical. Please see instructions and packaging of the different lines (standard, transfusion, opaque, enterel nutrition etc.) to receive information about preparation and usage of these lines.

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OPERATION Chapter 1 Insert the infusion line from right to the left. Make sure that the line is routed straight. At first, route the line through the upstream sensor. Then, insert the two-hole clip.

Next attach the white clip. Insure silicone segment is not stretched or twisted, stars on tubing must be in straight line and should not be twisted.

Insert the freeflow clamp (see red arrow) in the opened aperture, in the direction indicated by the arrow, until the opening lever locks in and the safety clamp squeezes the lines (flashing signal lamp goes out).

• Firmly press tubing into the air sensor guide to make sure the line is properly inserted into the sensors. Thread the tubing through the notches on the right and left side of the pump. • Close the pump door by firmly placing pressure with both hands on each side of the pump door, continue to press firmly until you hear and feel the motorized door latch pull the door shut. Do not open roller clamp until the pump directs you to do so when self test is completed. Then select the inserted line with t and confirm it with l. Open the roller clamp. Caution: Do not force door closed – If door is difficult to close, please check IV set and anti free-flow slide clamp (green) for proper installation. Caution: Before opening door, please close roller clamp and ensure door does not fall open. If door opens to the horizontal position, please check that the slide clamp (green) is properly occluding the IV set and the door extension hook is not broken. If the door hook is found damaged or broken remove the pump from service. 15

OPERATION Chapter 1 Caution: If a wrong line is selected the time until the pump goes into a pressure alarm may be prolonged. Also a wrong delivery rate is possible. • Press u if the prime function is enabled to prime the infusion line with the rate displayed. Cancel priming with k. Repeat the procedure until the line is completely primed. Then press d to proceed. Note: During priming, all air and drop alarms are switched off. • Establish the patient connection. • Answer the question whether the old therapy is to be used either with u or d (the question can be deactivated via the service manual). If you select u, the pump jumps to the Main Menu. Note: At rates smaller 10 ml/h the detection of a closed roller clamp cannot always be ensured due to physical reasons. A drop sensor may be used to avoid this risk. Adjusting the delivey rate: • In the Main Menu, open the rate with l and set it with q. s to start the infusion. VTBI is required to start the infusion. Time will • Press f be calculated when rate is entered. When time is entered, rate/doserate will be calculated. Running arrows on the display and the green LED indicate that the pump is infusing. Note: The running infusion can be cancelled at any time by pressing f s. The pump can be turned off at any time by pressing o for 3 sec (Exception: Data lock level 2) and as long a disposable is inserted. Handling with Infusomat® Space Line SafeSet Note: If Infusomat® Space Line SafeSet is used, VTBI is not required. A unique airtight filter membrane acts as a barrier, protecting against air-in-line situation. As the fluid level reaches the membrane, the upstream alarm will occur and the pump stops delivery whereas no air will pass the AirStop filter. For this reason a fast switch over to next container requires no aditionally workload for priming. In case of a "Check upstream" alarm, the upstream sensor detects an underpressure situation in the IV set between the pump and the drip chamber. Therefore check always if the roller clamp is open, if the line is kinked or if the bag and/or drip chamber is empty. Please do not start the pump again by not fixing the "Check upstream" alarm situation. If too many times, the pump is started without fixing the situation, the upstream sensor calibrates on the current existing underpressure in the line and air might pass the AirStop membrane. In this case please ensure that the the drip chamber is refilled and then open the door for recalibration of the upstream sensor. 16

OPERATION Chapter 1

1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time The Infusomat® Space offers the possibility to enter a volume- and time limit in addition to an infusion rate. When two of these parameters are entered, the third is calculated by the pump. If a volume and/or time is preselected, an arrow symbol is placed in front of one of these parameters in the Main Menu. It is called the “target”. During the infusion of the pump, this target symbol is displayed next to the moving arrows in the run display (this symbol is not visible in case TCI is used). This indicates that the pump has been programmed, either with a volume- or time limit. The assignment of the target symbol, apparent in the Main Menu, shows the established parameter for the application (VTBI or time). When the rate is changed, the so-called target parameter is principally not adjusted to the new rate but to the parameter which does not have the target symbol in front. After the infusion has started, the remaining VTBI and time are displayed in the status menu and the run display (values are counting down). 1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the bottom of the display. Target: Volume • Select VTBI with t and open with l. • Enter VTBI with q and confirm with k. • Select time with t and open with l. • Enter time with q and confirm with k. Check calculated rate on plausibility. Proceed in the same way to calculate 2.) and 3.). 2.) Infusion with volume limit Enter rate and VTBI: The infusion time will be calculated and displayed on the bottom of the display. Target: VTBI 3.) Infusion with time limit Enter rate and time: The infusion volume will be calculated and displayed on the bottom of the display. Target: Time Changing already entered values of VTBI and time (rate, VTBI and time already exist at the point of change): a) Target symbol is placed in front of VTBI: • Change of VTBI => Adjustment of time. Old and new target: VTBI • Change of time => Adjustment of rate. Old and new target: VTBI b) Target symbol is placed in front of time: • Change of time => Adjustment of VTBI. Old and new target: Time • Change of VTBI => Adjustment of time. New target: VTBI 17

OPERATION Chapter 1

1.3 Bolus Application After pressing the button b n, the bolus unit can be selected by using d. Note: The selected unit will not be stored. It is possible to administer a bolus in ml. There are three ways to administer a bolus: 1.) Manual Bolus: Press b n. Then press k and hold button. Fluid is administered for as long as the button is held down.. The infused bolus volume is displayed. The max. bolus time is limited to 10 sec. Reaching this limit is indicated by an acoustic signal. 2.) Bolus with volume preselection: Press b n. Then press l and set bolus dose limit by using q. Press b n to confirm and start bolus. Depending on the service tool settings an acoustic signal will sound after finishing the bolus volume. 3.) Bolus with rate calculation: Press b n. Then press l and set bolus dose by using q. Press k to confirm bolus dose. Set time with q in which a bolus is to be delivered. Calculated bolus rate is shown on top of the display. Press b n to confirm and start bolus. You can use the service program to enter a default and a maximum bolus rate. Once a new therapy is started the device always returns to the default rate - even if the bolus rate was manually changed beforehand. Note: If the bolus limit is not entered after pressing b n, the pump switches back into the run display automatically. Note: The infused volume during bolus with volume preselection counts up. n. In order to purge the line at any time while the pump is stopped press b Answer the following question by pressing u in order to start the purge process. Cancel by pressing k or any other key. Caution: Take care not to overdose! Given a bolus rate of 1200 ml/h, 1 ml will be administered in just 3 sec. To cancel bolus infusion at any time press k. At low bolus volumes, under dosages due to the start up characteristic of the pump and the tolerances in the infusion system cannot be excluded. Disconnect patient while purging.

1.4 Infusion Line Change and New Therapy Start Note: Always interrupt the patient connection before changing a line to avoid dosing errors. Never let the pump run unattended when changing the line. Check and clean the safety clamp regularly. 18

OPERATION Chapter 1 • Press f s to stop the delivery. The green LED goes out. Close the roller clamp and interrupt the patient connection. • Press x and open the pump door with u. Press down the green opening lever completely until it locks in place, remove the line and insert a new line. Note: In the unlikely event the pump door cannot be opened remove the allen key from the inside of the battery compartment cover. Use this key to remove the emergency aperture cover of the pump. Place the crank in the aperture and turn it clockwise until the pump door opens.

Push cover opening with pen.

Remove crank from inside of battery cover.

Turn crank to remove emergency aperture cover.

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OPERATION Chapter 1 Remove emergency aperture cover.

Turn crank inside aperture to open the door.

• Close the pump door, confirm the inserted line with k and open the roller clamp. • If required, prime the pump with u. Then press d to proceed when priming is complete. • Establish the patient connection and check the parameters with t. s. • Start the infusion by pressing f Note: A new therapy can be started at any time during a stopped infusion. If the pump is in the Main, Status or Options Menu, press C (repeatedly) and follow the instructions as described.

1.5 End of Infusion • Press f s to stop the infusion. The green LED goes out. Close the roller clamp and interrupt the patient connection. • Press x. Answer the question whether the pump door is to be opened with u. • Press down the green opening lever completely until it locks in place. Remove the line and close the pump door. • Press o for 3 sec to switch off the pump. Note: The settings will be permanently saved by the switched off device. Note: Pump cannot be powered off with IV line inserted.

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