Perfusor Space Instruction for Use Sw 688M April 2015

CONTENTS

Perfusor® 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...15 1.3 Bolus Application ...16 1.4 Syringe Change and New Therapy Start ...17 1.5 End of Infusion...18 1.6 Standby Mode ...18

Chapter 2

Advanced Operations ...19 2.1 Status Request of Pump when Infusion is Running...19 2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset of Status Menu Data...19

Chapter 3

Special Functions* ...20 3.1 Dosing Units and Dose Rate Calculation (Overview)...20 3.2 Dose Rate Calculation (Operation)...21 3.3 Drug Library...21 3.4 Patient Controlled Analgesia (PCA) (optional) ...24 3.5 Target Controlled Infusion (TCI) (optional)...26 3.6 Barcoding...32 3.7 Ramp and Taper Mode...32 3.8 Program Mode...34 3.9 Intermittent Mode ...36 3.10 Dose Over Time ...39 3.11 Take Over Mode (TOM) (optional)...41

Chapter 4 Chapter 5

Autoprogramming ...46 Options ...50 5.1 Occlusion Pressure ...50 5.2 OccluGuard & Pressure Leap/Drop detection (optional)...50 5.3 Data Lock ...53 5.4 Bolus Rate...54 5.5 KVO-Mode ...54 5.6 Contrast / Display Light / Keypad Light...54 5.7 Alarm Volume ...55 5.8 Date / Time...55 5.9 Macro Mode...55 5.10 Language...55

Chapter6

Alarms...56 6.1 Device Alarm...56 6.2 Pre-Alarms and Operating Alarms ...56 6.3 Reminder Alarms ...60 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 Chapter10 Chapter 11 Chapter 12 Ordering

Battery Operation and Maintenance...61 Compatible Syringes...63 Start Up Graphs and Trumpet Curves ...68 Technical Data...69 Warranty / TSC** / Service / Training / Cleaning / Disposal ...76 Instructions for Use Accessory ...79 ...84

2

PERFUSOR SPACE® OVERVIEW

P E R F U S O R ® 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.

c

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.

Drive head with claws to hold the syringe plunger plate and emergency release button.

Press to turn pump on/off.

B n o

f S Press to Start/Stop infusion.

Syringe holder locks syringe in position. The drive will automatically move back.

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.

Port P3 for future options

3

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

PERFUSOR® SPACE OVERVIEW

Syringe Fixation Pull and turn the syringe holder to the right to open the green axial fixation (see red arrow). Syringe must be fixed with wings upright in the slot (found to the left hand side of the axial fixation) before closing syringe holder. Make sure that syringe is properly inserted. Caution: Don't touch piston brake when moving forward. Pole clamp handle Pole clamp release button Pump slots

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 (Perfusor® Space or Infusomat® Space) plus one SpaceControl may be stacked together (in ambulance cars or 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.

4

Pole Fixation Push the opening of PoleClamp against the vertical pole and lock the screw tightly. Unscrew to release. For vertical fixation of PoleClamp 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 when used with the PoleClamp SP.

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) 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)

5

PATIENT SAFETY

PAT I E N T S A F E T Y

w

Intended use

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is Read Instructions intended for use on adults, pediatrics, and neonates for the intermittent or confor Use prior to use. tinuous delivery of parenteral and enteral fluids through clinically accepted The infusion device routes of administration. These routes include, but are not limited to intrashould only be venous, intra-arterial, subcutaneous, epidural, and enteral. The system is used used by specially for the delivery of medications indicated for infusion therapy including but not trained staff. limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc.; blood and blood components; Total Parenteral Nutrition (TPN); lipids, and enteral fluids. The Perfusor® Space Infusion Syringe 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 The medical specialist must decide on suitability for application on the basis of the warranted properties and the technical data. Operation • The initial training of the Perfusor® 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 of the changes to the device and accessories by referring to 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 and the accessories (especially the axial fixation) for damage, missing parts or contamination and check audible and visible alarms during selftest. 6

• Not be used adjacent and stacked with other equipment except B. Braun Space devices.

PATIENT SAFETY

• Only connect to patient once the syringe has been inserted correctly and there is proper fixation of the syringe pressure plate by the claws of the drive head. Interrupt connection during syringe change to prevent incorrect dose delivery. • Select syringe/catheter suitable for use with the intended medical application. w Caution: Position the infusion line free of kinks. 4

• Recommended change of disposable each 24 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 4 to 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. • Do not carry the pump device by it's drive mechanism during transportation. • If the pump device falls or is exposed to force it needs to be examined 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. • Avoid applying external force on the drive mechanism during administration. • 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. • In case values relevant for the dose rate calculation (e.g. body weight) 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. 7

PATIENT SAFETY

Enteral Nutrition The Perfusor® 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. 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 the according 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. • The use of incompatible disposables may influence the technical specifications of the device. • 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 Perfusor® 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 distancesrecommended by the manufacturers of these devices. • The Perfusor® Space fulfils the applicable requirements of EN 13718 to be used in the air, on the water and in difficult terrain. During transport the Perfusor® Space needs to be fixed on a suitable restraint system by means of SpaceStation or Pole Clamp SP. When stored under temperature conditions beyond the defined operating conditions the Perfusor® Space needs to remain under room temperature at least one hour before usage. Safety Instructions for using PCA 8

• In case the demand button is used with SpaceStation the PCA pump has to be placed in the lowest slot of the lowest SpaceStation.

PATIENT SAFETY

• 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. • For additional safety the removal of the syringe can be prevented by the use of the Syringe Anti Removal Cap (see accessories) and the locking of the syringe holder. The Syringe Anti Removal Cap is usable for the following syringes: B. Braun Original Perfusor Syringe 50 ml, B. Braun Omnifix 50 ml, BD Plastipak 50/60 ml and Tyco Monoject 50 ml. The locking of the syringe holder is under the pump and is locked by a clockwise turn of 90°. Make sure the syringe holder is safely locked. Opening of the syringe holder may not be possible after locking. • In case opioids are administered and the Syringe Anti Removal Cap is not in use and the syringe holder is not locked the therapy only should be performed under surveillance of medical staff. This especially is necessary in case non-authorised access to the drug can be anticipated. • 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. • Consider startup characteristics before using low infusion rates (0.1ml/h) with critical drugs. 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. 9

PATIENT SAFETY

• 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. • 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.

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.

10

MENU STRUCTURE / NAVIGATION

MENU STRUCTURE / NAVIGATION Cutline o

On/Off button

k

OK button

f s

Start/Stop button

q

b n

Bolus button

Keypad with arrow up, -down, -left, -right button

c

Clear 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: Mains connection Battery status

Set pressure limit and current pressure* *See also OccluGuard

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

11

MENU STRUCTURE / NAVIGATION

Display

Meaning All status information is available in the bottom line of the dislplay. The desired information can be selected by using d u and will be displayed permanently thereafter (e. g. drug long name, time until syringe empty, 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 the message on the display (e.g. “Syringe nearly empty”), 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. "Syringe empty") the infusion stops, an audible tone sounds and the red LED is flashing. 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 a syringe inserted the pump will not turn off but will use standby.

12

MENU STRUCTURE / NAVIGATION

Start Up Menu

Main Menu

Special Functions

Options Menu

Status Menu

Syringe selection

Dose

Dose Rate Calculation

Occlusion Pressure

Intermediate volume

Prime ?

Concentration

Drug Library

OccluGuard

Intermediate amount

Use last therapy ?

Weight

Change-over from continuous mode to PCA

Pressure Leap/Drop

Intermediate time

Use dose rate calculation ?

Rate

Data Lock

Total volume

Use drug library ?

VTBI

Bolus Rate

Total amount

Time

KVOMode

Total time

Special Functions

Contrast

Pressure

Options

Display Light

OccluGuard Status

Status

Keypad Light

Syringe

Alarm Volume

Battery capacity

Date

WLan

Time

Version

Macro Mode

Drug info

In Dose Mode: Display of flow rate in large scale

Language

13

OPERATION Chapter 1

OPERATION 1.1 Start of Infusion • Ensure correct installation of the pump device. If the pump is connected to mains, the display states information such as the battery status, the mains connection symbol and the last therapy. • Press o to switch on unit. Note the automatic selfcheck: “Selftest active” and the software version are displayed, two audible tones sound and all three LEDs (yellow, green/red and blue) flash once. Information on power supply (battery or mains connection), the set pressure level and the syringe (if syringe already inserted) are displayed. Hence the drive moves backwards. 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 with direct entry of therapy parameters or open pump cover and syringe holder to start with syringe insertion. • Insert syringe with wings of the syringe upright in the slot to the right of the housing. Close syringe holder and pump door. Piston brake moves forward. Caution: Never leave the pump unattended during syringe loading. • Confirm syringe type with k. Type of syringe indicated must coincide with syringe inserted. • Drive will advance and grip pressure plate of syringe. Caution: Keep your hands away from advancing device. Note: Make sure that the piston brake moves back into the syringe holder. • If the prime function is activated, press U to prime infusion set at 1200 ml/h (pressing key once = 1 ml). Interrupt prime function with k. Repeat procedure until infusion line is fully primed. Then press d to proceed. • Connect with patient. • Respectively answer questions in Start Up Menu with u and d, until the rate is displayed in the Main Menu. Enter infusion rate: • Press l and set rate using q. 14

OPERATION Chapter 1 • Press f s to commence infusion. Running arrows on display and green LED above display indicate pump is infusing. Note: Stop the infusion 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.

1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time The Perfusor® 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 at the bottom of the display. Target: VTBI 3.) Infusion with time limit Enter rate and time: The infusion volume will be calculated and displayed at 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): 15

OPERATION Chapter 1 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 Note: Changing VTBI/time is only possible while the pump has been stopped.

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: n. Then press k and hold button. Fluid is 1.) Manual Bolus: Press b administered as long as button is held down. The infused bolus volume is displayed. The max. bolus volume 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 u 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. 16

OPERATION Chapter 1

1.4 Syringe Change and New Therapy Start Note: To avoid incorrect dosing, always disconnect the pump from the patient when changing the syringe. Never leave the pump device unattended during syringe change. Before inserting a new syringe check if the axial fixation is properly working. s to stop the infusion. The green LED will disappear. • Press f Disconnect the pump from the patient. • Either the drive mechanism moves backwards into starting position when opening syringe holder or the question "Perfom change?" must be first answered before the drive moves backwards. • Open pump door, remove syringe and insert new syringe. Note: In case the plunger head of the syringe is not released anymore by the claws when performing a syringe change, the emergency release button needs to be pressed to release the claws of the drive head. The emergency release button is placed on the outside of the drive head. It can be released with a pointed pen. Then manually open the claws and take out the syringe. • Close the syringe holder (Note: Piston brake must move forward!) and the pump door and confirm the inserted syringe type with k. Drive advances and grips pressure plate of syringe. Note: Do not block advancing drive unit with any objects. Piston brake must move backwards into the syringe holder. • Prime pump if necessary with u then press d to continue. • Connect the patient to the pump and check set parameters using t. s to start infusion. • Press f To start a new therapy after a syringe change: • Press c when pump is in the Main Menu. • Press d and continue to set new therapy parameters with q. • Press f s to start infusion. Note: A new therapy can be started at any time during a stopped infusion. Press c (repeatedly) when the pump is in the Main-, Status- or Options Menu and proceed to follow instructions as described.

1.5 End of Infusion • Press f s to stop the infusion. The green LED disappears. Disconnect the pump from the patient. • Open the syringe holder. Answer the question whether a syringe change should be performed with u. The drive moves backwards into the starting position. 17

OPERATION Chapter 1 • Open pump cover. Remove the syringe, move the syringe holder into an upright position and close the front door. • Press o for 3 sec. to switch the pump off. The drive moves into parking position. Note: The settings will be permanently saved by the switched off device. Note: Pump cannot be powered off with syringe inserted.

1.6 Standby Mode In the case of extended interruption, the user has the option to maintain the set values. s to stop the infusion. Then press o for less than 3 sec. • Press f • Confirm that the pump is supposed to switch into standby by pressing u. • The pump is now in Standby. While the pump is in the standby mode, it’s display shows the drug and the remaining time for this mode. Change of remaining time by pressing l. Exit standby by pressing c . As long as a disposable is inserted in the pump will use standby also in case o is pressed for at least or more than 3 sec.

18

OPERATION Chapter 1

ADVANCED OPERATIONS 2.1 Status Request of Pump when Infusion is Running Press c to switch between run display and Main Menu while the device is infusing. Navigate through the menu using t to check parameters. In order to check the menu parameters in the Status-/Options Menu, select "Status" respectively "Options" in the Main Menu, open menu with l and scroll through menu with t.

2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset of Status Menu Data • Press c when the pump is in the run display in order to switch to the Main Menu. Select rate/VTBI/time with t and press l in order to open the parameter. • Enter new value with q and confirm with k. Reset Status Menu Data: The parameters intermediate volume and -time can be reset when the pump is infusing or when the pump is stopped. • Select “Status” in Main Menu with t and press l. • Highlight intermediate volume (in ml) or intermediate time (in h:min) with t and open parameter with l. • Reset values by pressing u. Both parameter total volume and -time, are displayed in the pump as "Total" with the according unit and can be reset by starting a new therapy. A second way to reset the parameters when the pump is in the Main Menu: Press c, answer question if the last therapy is to be used with u and reset the values with u. The type of the inserted syringe is displayed in menu item „Syringe“ and cannot be changed once it has been confirmed at the beginning of the infusion. The drug info states the drug name, the name of the drug list and its date of origin. The current battery capacity in hours and minutes is displayed in the menu item “Battery Cap.” and the current software version in menu item "Version". In-line pressure can also be read in the Status menu in mmHg or Bar depending on the service settings.

19

ADVANCED OPERATIONS Chapter 2

SPECIAL FUNCTIONS 3.1 Dosing Units and Dose Rate Calculation (Overview) The following list shows the units used in the pump: Gram family: ng, mcg, mg, g Unit family: mIU, IU, kIU, MIU Equivalents family: mEq Mole family: mmol Kilocalorie family: kcal Millitliter family: ml, ml/kg In addition to these dosing units the user can choose: • •

Feeding: kcal, mEq, mmol Surface related amount units: m2

Infusion rate [ml/h] =

Dose x Concentration

[ Patient weight (optional) ]

The pump is calculating the body surface area with the “Dubois” formula (DuBois D, DuBois EF. A formula. Arch Intern Med 1916; 17: 863): BSA(m2) = 0.007184 x weight(kg)0.425 x height(cm)0.725. Check plausibility of calculated body surface area value and resulting delivery rate before starting the infusion, also, if body surface area related dose rate is set by Barcode. The dose rate calculation enables a calculation of the rate in ml/h based on the entered dose parameters. Setting parameters: 1. Concentration as the amount of the active ingredient per volume. - Amount of the active ingredient - Volume in ml 2. Where necessary: Patient weight or Patient height Note: - Patient weight can be entered in kg, lbs or grams. - Patient hight is entered in m (is used to calculate BSA) 3. Dose prescription: - time related as the amount of the active ingredient per min, h or 24h. - time and patient weight related as the amount of the active ingredient per kg per min, h or 24h or BSA. 4. Where necessary: VTBI in ml.

20