Infusomat Space Instructions for Use Sw 586U Aug 2015

CONTENTS

Infusomat® Space Overview ...3 Symbols on Product...9 Patient Safety ...11 Menu Structure / Navigation...13 Entering values ...15 Chapter 1 Operation...18 1.1 Inserting and Priming line in Pump...18 1.2 Drug Library...20 1.3 Programming a PRIMary Infusion in the Drug Library ...25 1.4 Programming a SECondary Infusion in the Drug Library ...28 1.5 Programming an Intermittent Dose Over Time Infusion ...32 1.6 Programming a Loading Dose in the Drug Library...33 1.7 Programming a Bolus with Dose and Time in the Drug Library ...35 1.8 Manual Bolus...36 1.9 Changing Care Unit ...37 1.10 Changing display while pump is running ...38 1.11 Basic Infusion (programming the pump outside of the drug library) ...38 1.12 IV Line Change and New Therapy Start...40 1.13 End of Infusion...41 1.14 Standby Mode ...42

Chapter 2

Pump Menus...43 2.1 Infusion Totals...43 2.2 Options ...44 2.2.1 Downstream Occlusion Pressure...44 2.2.2 Upstream Pressure ...44 2.2.3 Alarm Volume ...44 2.2.4 Dose Rate Calculator...44 2.2.5 Data Lock ...48 2.2.6 KVO Mode...48 2.2.7 Contrast / Display Light / Keypad Light...48 2.2.8 Bolus Rate...49 2.2.9 Date / Time...49 2.2.10 Macro mode ...49 2.3.11 Wireless Activation ...49 2.3 Status Menu...49

Chapter 3

Alarms...51 3.1 Device Alarms ...51 3.2 Pre-Alarms and Operating Alarms...51 3.3 Reminder Alarms ...53 3.4 Alarm Prompts...54

Chapter 4 Chapter 5 Chapter 6

*The availability of the listed features depends on the configuration of the pump's biomed file. **Technical Safety Check.

Wireless Drug Library Upload...55 AutoProgramming and Barcoding...58 Battery Operation and Maintenance...61 6.1 General...61 6.2 Safety Instructions...62 6.3 Battery with WiFi ...62 6.4 Battery maintenance...63

Chapter 7 Chapter 8 Chapter 9 Chapter 10 Ordering

Start Up Graphs and Trumpet Curves ...66 Technical Data...67 Warranty / Training / TSC** / Service / Disinfection / Disposal ...76 Optional Space Accessories...80 ...84

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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 Follow on screen prompts using arrow keys to navigate menus, select parameters, change values and respond to on screen prompts.

q

Press to clear values in programming screens or to go back one screen.

Press to open the pump door.

c

x

Yellow LED: Pre-alarm, reminder alarm Press to initiate bolus.

Green or Red LED: or Green LED: Infusing Red LED: Operating or Device Alarm Blue LED:

B n o

Initiating connection to wireless battery or SpaceStation

k Press to select and/or confirm values/settings/alarms/messages.

Press to turn pump on/off and initiate stand by mode.

m

f S

Press to initiate auto-programming orders when prompted.

Press to Start/Stop infusion.

Cover of Battery Compartment Before changing the battery, always disconnect the pump from the patient and switch the device off. To remove the battery cover, push the button below the battery compartment with the point of a pen and pull the cover away from the device. Slide the green locking mechanism on the back of the battery up and take out the battery pack for repalcement. A crank key used to open the pump door, which is stuck closed, is attached to the inside of the battery compartment cover (for more information see subchapter 1.12).

Port P3 for future options

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Port P2 for power supply, SpaceStation, combi lead and additional accessory leads (staff call, service plug)

INFUSOMAT® SPACE OVERVIEW

Anti-free flow clip (set based free flow protection)

Opening lever

Downstream pressure sensor

Pump based free flow prevention safety clamp

Air sensor

Line Loading Guide

Yellow caution light

Line guide cover

Upstream pressure sensor

Pole Clamp SP (model 8713130)

Rotation lever

Pole clamp release button

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Attaching Pole Clamp to IV Pole Position the opening of the Pole Clamp on pole and turn the grey locking knob clockwise until pole clamp is secured to IV pole. Turn grey knob counter clockwise to release. For vertical positioning of Pole Clamp push rotation lever down and rotate pump either way until lever clicks into notch. Push lever for rotation. Caution: Do not lean on pump when attached to pole! Caution: A maximum of three B. Braun Space pumps can be stacked together when used with the PoleClamp SP.

INFUSOMAT® SPACE OVERVIEW

Attaching Pump to Pole Clamp Line up slots on top sides of pump with grooves of Pole Clamp and slide pump into Pole Clamp until locking mechanism clicks. To remove, simultaneously press release button on frame and push handle down while pulling pump out from pole clamp.

Pole clamp handle Pole clamp release button

Pump slots

Locking Devices Together A maximum of three pumps (Infusomat® Space or Perfusor® Space) may be inter-locked on a single pole clamp. Caution: Avoid external mechanical action. Line up the grooves of the lower pump with the slots of the upper pump and slide the lower pump in until the lock clicks and the green buttons are aligned with each other. To disconnect, push green locking button of upper pump and slide lower pump out.

The pump is now securely attached to Pole Clamp. • Do not position the pump unit over the patient.

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

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INFUSOMAT® SPACE OVERVIEW

Space Pole Clamp (speed clamp) (model 8713131)

Attaching Pole Clamp to IV Pole Position the opening of the Pole Clamp on pole and turn black knob clockwise until pole clamp is secured to IV pole. Turn black knob counter clockwise to release from IV pole.

Attaching Pump to Pole Clamp Line up slots on top sides of pump with grooves of Pole Clamp and slide pump into Pole Clamp until locking mechanism clicks.

The pump is now securely attached to the pole clamp. • Do not position the pump unit over the patient.

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INFUSOMAT® SPACE OVERVIEW

Locking Devices Together Line up the grooves of the lower pump with the slots of the upper pump and slide the lower pump until the lock clicks and the green buttons are aligned with each other. To disconnect, push green locking button of the upper pump and slide lower pump out. A maximum of three pumps (Infusomat® Space or Perfusor® Space) may be interlocked on a single pole clamp.

Caution: Avoid external mechanical action. Removing Pump from Pole Clamp Pull both end tabs simultaneously to gently eject/release the pump from pole clamp. Slide pump out by hand to remove fully from pole clamp.

➀

➁

Vertical Positioning Simply turn the pump either way until it clicks into notch at 90 degree/vertical position.

➂

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INFUSOMAT® SPACE OVERVIEW

Caution: Do not lean on pump when attached to pole! Caution: A maximum of three B. Braun Space pumps can be stacked together when used with the Space Pole Clamp (speed clamp).

Power supply holder The Space Pole Clamp (speed clamp) can hold up to 2 Space Power Supplies (8713112D) on the rear of the pole clamp.

DO NOT use any Pole Clamp that shows signs of damage.

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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

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SYMBOLS ON PRODUCT

List of abbreviations KVO = Keep Vein Open LED = Light-Emitting Diode (indicator lamps) TPN = Total Parenteral Nutrition

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VTBI = Volume To Be Infused MRI = Magnetic Resonance Imaging BSA = Body Surface Area

PATIENT SAFETY

PAT I E N T S A F E T Y Indications for Use Read Instructions for Use prior to operation. The infusion device should only be used by trained healthcare professionals.

The Infusomat® Space Volumetric Infusion Pump System is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes include intravenous, intraarterial, subcutaneous, and epidural. Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities. Dedicated Disposables The Infusomat Space is intended to be used with only dedicated disposables labeled for the different routes of administration. Warnings and Cautions • The initial training of the Infusomat® Space is to be performed by B. Braun sales and/or clinical personnel or other authorized persons. After each software update, the user must refer to the Instructions for Use to review changes to the device and software. Caution: Ensure the unit is properly positioned and secured (see ch. Infusomat® Space Overview). Do not position pump above patient or in a position where a patient could be harmed , 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. • Only connect to patient once the line has been correctly inserted and completely primed (chapter 1.1). Disconnect from patient during line change to prevent unintended delivery. Caution: Insure the infusion line is free of kinks. Caution: Do not operate in the presence of flammable anesthetics or in a hyperbaric oxygen chamber. • Not be used adjacent and stacked with other equipment except B. Braun Space devices. Caution: The Infusomat Space System is unsafe to use in proximity to magnetic resonance imaging (MRI) equipment. • Compare the displayed value with the entered value prior to starting infusion. 11

PATIENT SAFETY

• Compare physician order to programming parameters including drug name, patient profile and dosing prior to starting infusion. • Check default values pre-populated from drug library with physician order prior to starting infusion. • Consider additional monitoring which may be required when infusing high risk medications. • Consider plausibility of calculated flow rate for infusions programmed with BSA to assist in determining accuracy of patient height and weight values. • If staff call is used, it is recommended to check the equipment once after connecting the pump to insure staff call is working. • If the pump is dropped or is exposed to force, it must be checked by the service department. • The default values and limits of the Drug Library provide a safety net and are not intended to be used to define treatment. • Changes in position of pump height in relation to patient during infusion may lead to minor changes in flow accuracy. • Do not allow liquids to enter into or come into contact with any openings or electrical connections on the pump or power supply. Fluid exposure in these areas may result in the risk of short circuit, corrosion or breakdown of sensitive electrical components, and/or electrical shock. If fluid exposure occurs, the device should be swapped out with another device in a manner that presents minimal interruption to patient care. The device should remain unplugged until it can be inspected by a trained technician for any evidence of damage and/or residual moisture which may impair the function of the device. Safety Standards Infusomat® Space satisfies all safety standards for medical electrical devices in compliance with IEC 60601-1:2005 and IEC 60601-2-24: 2012. • The EMC-limits (electro-magnetic compatibility) according to IEC 60601-12:2007 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. • During transport of patients within the facility the Infusomat® Space needs to be fixed on a suitable restraint system by means of SpaceStation, Pole Clamp SP or Space Pole Clamp (speed clamp). • 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. 12

MENU STRUCTURE / NAVIGATION

MENU STRUCTURE / NAVIGATION Overview of Keys and Displays o x f s b n

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

C K Q m

Clear and/or back key OK key Keypad with arrows Initiation of Auto-programming order

All display screen shots are examples and may be different depending on pump configuration and infusion settings. Display

Meaning At the top of the screen the last infusion is indicated. "Continue last infusion" question can be answered with Yes/No question by pressing u for yes or d for no. Pressing yes recalls all parameters of the last infusion prior to power off, both the last primary and secondary therapies are retained. Parameters can be changed (e.g. rate in ml/h) by opening the editor screen with with l or k. When editing parameters, use the l or r to move to the digit to be programmed. The white background indicates current digit. Use u or d to change current setting or C key to clear the values. Text on the bottom or top of the screen indicates infusion mode, soft limit symbol.

Typical display during infusion: Wireless Current Set pressure limit pressure level Infusion mode

Connected to Power/Battery Status Scrolling arrows indicate pump is infusing Set rate can be opened with l to edit

Soft limit indicator Drug name

Unit of drug delivery Infusion status information

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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 (e. g. care area, drug long name, time/ VTBI remaining drug concentration, total volume, infused totals for PRIMary and SECondary) until changed by user. This prompt appears 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 a flashing yellow LED. To confirm a pre-alarm press k. Operating alarms stop the infusion, an audible tone sounds and the red LED flashes. Confirm alarm by pressing k. Confirming does not provide 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. The IV line must be removed to power the pump off. Pump will go into stand-by if the IV line is not removed.

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ENTERING VALUES

ENTERING VALUES For an infusion parameter to be entered and/or edited, the pump displays the name of the value being edited (rate, doserate, etc), format and unit of measure (dosing unit, volume, time, etc). In the screen below, a Doserate value is to be entered, which in this case is specified as mcg/kg/h. The underbars indicate the places which can be entered both to the left and right side of the decimal point. The value to be entered must be selected by using the arrow buttons to move the cursor so the desired numerical value to be changed is highlighted. Use the Left and Right arrows buttons to move the cursor and the Up and Down arrows keys to increase or decrease the number. Entering a new value: For example, a value of 9.5 can be entered by pressing the Up arrow button u in the “ones” place 9 times and then press the Right arrow button r once to move the cursor to the “tenths” decimal place and pressing the Up arrow button u 5 times. Press the OK button k to confirm the value, as indicated in the title bar of the display.

Titrate an existing value: Select the value to be changed by using the right r and left arrow l keys to highlight desired number, in this case the “ones” place. To Titrate to another value, e.g. 11.5 press the Down arrow button d eight times to get 1.5 Then press the Left arrow button l to move the cursor to the “tens” place and press the Up arrow button u once .

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ENTERING VALUES

Arithmetic logic: An alternative method for entering and titrating values uses arithmetic logic:

Pressing the Up arrow u one time in the “ones” place increases the value to 10.5

Pressing the Down arrow button d from the “ones” place decreases the value to 9.5 Pressing the Up arrow button u from the “ones” place 2 times increases the value to 11.5

Hard Limits: The editor function keeps the displayed values between the minimum and maximum hard limits for the selected infusion parameter. This can be either general pump limits or drug specific limits defined in the drug library. In case an increase of a value would exceed a hard limit, the pump displays the highest acceptable value presuming the user wanted a maximum value. Example: Assume the selected drug has a hard limit set at 15 mcg/kg/h. Trying to titrate from 9.5 to 19.5. Press the Left button l to move the cursor to the “tens” place. Press the Up button u in order to increment to 19.5. As 19.5 is above the limit, the value displayed is 15, as the hard limit is the highest acceptable value.

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ENTERING VALUES

IMPORTANT: If a value increase or decrease is not possible due to a hard limit (as 19.5 could be expected in this case), the value of the hard limit is displayed as the highest acceptable value. If the down arrow d is pressed on the above screen, the pump displays the previous value i.e. 9.5. If the up arrow u is pressed on the above screen, the pump displays a clear message that the value entered exceeds the hard limit. After the user confirms the message by pressing the OK button k, the pump prefills the programming editor field with the last value programmed and confirmed prior to the value that created the alert. While in the editor function the arrow buttons Q and the OK button k are used to define and confirm a value, the C (clear) button c can be used to reset the value to 0. To exit the editor function, press the C button c again. The value of the infusion parameter reverts to the last confirmed value.

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OPERATION Chapter 1

OPERATION 1.1 Inserting IV Line and Priming in Pump • Ensure that the pump is properly installed (see Infusomat Space Overview above). Check the equipment for completeness and damages. • Spike infusion bag and fill drip chamber to 2/3 full. • Press o to power on. 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. The power supply indicator and the set pressure level are displayed followed by the set limit for the accumulated air volume and the max. size of air bubbles. • Observe B. Braun landing page and press k to enter infusion parameters followed by IV line insertion, or press x and then press u to open the pump door and insert the line.

Note: Observe message indicating the roller clamp should be closed during set change. Caution: Close the roller clamp before inserting the IV line and do not connect to patient until properly loaded and primed.

Insert the IV line from right to the left starting with the 2 hole clip.

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OPERATION Chapter 1 Next attach the white clip. Insure silicone segment is not stretched or twisted, stars on tubing must be in straight line and line loading guide should not be twisted.

Anti-Free Flow clip insertion Safety clamp Door hook

Insert the green anti-freeflow clip in the green slot, in the direction indicated by the arrow, until the opening lever snaps out, yellow light goes out and pump based free flow protection safety clamp occludes the lines.

Air sensor guide

• 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. Caution: Pump door will not close if the anti free flow clip is not properly inserted. Do not force door closed - if door is too difficult to close, check IV line and anti free-flow clip (green) for proper loading. Caution: Before opening door, close roller clamp. If the door hook appears damaged or broken remove the pump from service. • If priming is activated, press u to select yes to prime IV line and note prompt to disconnect IV line from patient before priming. Press k to confirm and begin priming. Respond to "priming stopped" message by confirming with k. Respond to "repeat priming" prompt with u for yes if line is not fully primed or d for no if fully primed. Please refer to the priming volume on each disposable label.

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OPERATION Chapter 1

Note: During priming, all air in line alarms are inactive. • Connect IV line to the patient and observe B. Braun landing page. Press k to program infusion. Note: Pump automatically powers up in the drug library for all new infusions.

Note: Last infusion, if any, will be displayed with prompt "Continue last infusion?". Press u for yes or d for no. If yes, confirm each infusion parameter by scrolling with t and pressing k to confirm values. If no, press k on B. Braun landing page to program new infusion.

1.2 Drug Library The Space Infusomat powers up in the drug library, providing a safety net for clinicians during programming. The drug library allows for up to 1200 drug names in up to 10 concentrations per drug to be sub-divided into 30 categories. These drugs can be assigned to 50 care units and 16 Patient Profiles. Drug categories allow the drug names to be subdivided, such as by drug type. Patient profiles allow one drug to have different settings such as dose limits, concentration, clinical advisories, pressure limits, and infusion type based on patient type or condition. Care Units allow drugs to have different settings based on location or classes of patients. • The pump will prompt user to enter weight for weight based dosing and BSA for m2 dosing.

Note: Changing the weight during a weight based infusion or BSA during a m2 infusion will result in a change in the infusion rate to deliver the programmed dose at the new weight. 20