Space Plus Infusomat Instructions for Use Ver 1.0

Elements for automatic InDesign functions: See section 1 Figure 1 Table 1

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Table of contents 1 1.1 1.2 1.3

About these instructions for use...5 Purpose of these instructions for use... 5 Warnings... 6 Abbreviations... 6

2 2.1 2.2

Symbols...7 Symbols on the product and packaging... 7 Status indicators on the display and housing... 8

3

Intended purpose...9

4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15

Safety instructions...10 General use... 10 Inspection on delivery... 10 Before and during use... 10 Cleaning... 11 Protecting patients... 11 Alarm volume and patient call... 12 Setting up the device... 12 Device environment... 13 Using the infusion line correctly... 14 Transporting the device... 14 Avoiding damage to the device... 15 Accessories... 15 Maintenance, servicing and spare parts... 15 Software and updates... 15 Safety standards... 16

5 5.1 5.2

Device overview...17 Front... 17 Back... 18

6 6.1 6.2 6.3 6.3.1 6.3.2 6.4 6.5

Ports and connections...19 Attaching/detaching the pump clamp... 19 Connecting/disconnecting pumps... 19 Connecting cables... 20 Power cable... 20 Accessory cable for bolus button and patient call... 20 Short stand SP (8713135)... 20 Attaching / Removing pump to Lockbox... 20

7 7.1 7.2 7.3

Operating the device...22 Categories... 22 Entering values... 22 Deleting values... 22

7.4

Disabled controls... 22

8 8.1 8.2 8.3 8.3.1 8.3.2 8.3.3 8.4

Display screens...23 General status displays... 23 Home menu... 23 Menus... 23 Drug data menu... 24 Patient data menu... 24 Infusion data menu... 24 Run screen... 24

9 Main functions...26 9.1 Switching on, switching off and standby... 26 9.2 Programming an infusion... 26 9.3 Starting an infusion... 26 9.4 Pausing/ending an infusion... 26 9.5 Locking/unlocking the display... 26 9.6 Administering a bolus... 27 9.6.1 The bolus menu... 27 9.6.2 Programming a bolus... 27 9.6.3 Reusing a programmed bolus... 27 9.6.4 Administering a manual bolus... 27 9.6.5 The bolus run screen... 28 9.7 Changing the infusion line... 28 9.7.1 Inserting the infusion line... 28 9.8 Priming the line... 30 9.9 Totals & Info... 30 9.9.1 Totals... 30 9.9.2 Infusion status... 31 9.9.3 Infusion history... 31 9.10 Keep vein open (KVO mode)... 31 9.11 Changing the device settings... 32 9.11.1 Activating or deactivating the code lock... 32 9.11.2 Selecting pressure level... 33 10 10.1 10.2 10.3 10.4 10.5

The drug library...34 Accessing the drug library... 34 Programming an infusion with the library... 34 The limits... 36 The review screen... 37 Changing the drug data during an infusion... 37

11 11.1

Description of the infusion profiles...38 Rate/volume/time... 38

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Table of contents 11.1.1 11.1.2 11.1.3 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9

Overview of infusion parameters... 38 Use with an ­Infusomat® Space Line SafeSet... 38 Changing the infusion parameters... 39 Dose calculation... 39 Dose over Time... 39 Autoprogramming ... 40 Secondary / Piggyback... 41 Pain controlled Analgesia (PCA) ... 42 Programmed intermittent Bolus (PIB)... 42 Patient Data Synchronization... 43 Distributed Alarm System... 43

12 Hints & alarms...45 12.1 Hints... 45 12.2 Service hints... 45 12.3 Alarm display... 45 12.4 Alarm priorities... 45 12.5 Alarm types... 46 12.5.1 Notifications... 46 12.5.2 Reminders... 47 12.5.3 Pre-alarms... 47 12.5.4 Operating alarms... 48 12.5.5 Device alarms... 50 13 13.1 13.2

Software & updates...51 Updating the drug library... 51 Activating additional updates ... 51

14

Cleaning & disinfection...51

15 15.1 15.2

Battery operation and care...53 Notes on battery life... 53 Battery change... 53

16

Decommissioning...53

17

Warranty...53

18

Maintenance and repair...54

19

Disposal...54

20 20.1

Technical Safety Check (TSC)/service...54 Electrical Safety Inspection... 54

21 21.1 21.2

Start-up and trumpet curves...55 Significance for clinical practice... 55 Typical start-up and trumpet curves... 56

22

Time to alarm...57

23 23.1 23.2

Technical data...58 Pump... 58 WiFi interface... 63

24 24.1 24.2 24.3

Electromagnetic compatibility...65 Electromagnetic interference emissions... 67 Electromagnetic immunity... 68 Recommended safe distances... 72

25 25.1 25.2

Instructions for use for accessories...73 12 V interface cable (871923112)... 73 Staff call interface cable (8718031)... 73

26 Ordering data...75 26.1 Infusion pump... 75 26.2 Interface cable... 75 26.3 Recommended accessories... 75 26.4 Power cord... 75 26.5 Disposables... 76 26.5.1 ­Infusomat® Space lines... 76 Index ...80

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About these instructions for use 1 About these instructions for use 1.1

Purpose of these instructions for use

These instructions for use are part of the device and describe how to use the device safely and correctly. – Read these instructions for use before using the pump! – Keep the instructions for use near the pump! – Please read and follow the accompanying documents! An electronic instructions for use (eIFU) of all medical devices can be found on the manufacturer’s eIFU website: www.eifu.bbraun.com. By typing the document article number and language code into the search field, the required revision will be available. You can view, save or print the IFU. All previous versions of the IFU are available. A printed version can be provided by the manufacturer on request free of charge within 7 days in the respective language.

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About these instructions for use 1.2

Warnings

Various warnings are used in these instructions for use with the following meaning: Symbol

Meaning Danger for people. Non-compliance will lead to death or serious injuries.

DANGER Danger for people. Non-compliance could lead to death or serious injuries. WARNING Danger for people. Non-compliance could lead to minor injuries. CAUTION

1.3

Abbreviations

Abbreviation

Meaning

BSA

Body surface area

EMC

Electromagnetic compatibility

ESD

Electrostatic discharge

HF

High frequency

KVO

Keep vein open

LED

Light emitting diode

ME device

Medical electrical device

MRI

Magnetic Resonance Imaging

PCA

Patient controlled analgesia

TSC

Technical safety check

VTBI

Volume to be infused

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Symbols 2 Symbols 2.1

Symbols on the product and packaging

Symbol

Meaning Caution Consult instructions for use Mandatory action: see instruction for use

Symbol

Meaning Date of manufacture Manufacturer Moisture limit Temperature limit

Marking of electrical and electronic equipment in accordance with Directive 2012/19/EC (WEEE)

Atmospheric pressure limitation

CE marking

Federal Communications Commission Registration

Alternating current Protective insulation; class II equipment Defibrillation-proof type CF applied part

For a safe use of the Spaceplus infusion pump in MRI environment follow the instructions for use “Spaceplus MRI Station” Battery recycling

Catalogue number Batch code

Non-ionising electro­ magnetic radiation

Serial number

Medical device

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Symbols 2.2

Status indicators on the display and housing

Symbol

Description Takes you to the main menu (home menu); All central functions can be accessed here Switches the pump on and off, or puts it in standby Infusion running Bolus or loading dose running Infusion has been paused WiFi connected, incl. strength WiFi not connected or not available Connected to OnlineSuiteplus, incl. strength Software or drug library update available Pump is in service mode; Do not use with patients! Pump is in battery mode; battery level. Battery is red if 20% or less remains Pump is connected to mains power; Battery level Battery is missing or defective Alarm Alarm sound is temporarily muted Alarm sound is permanently muted Parameter is above the upper soft limit Parameter is below the lower soft limit The pump is too cold Connected to OnlineSuiteplus; Alarm is distributed to other system Connected to OnlineSuiteplus; Alarm is distributed to other system; Alarm at Spaceplus pump / Station is silent

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Intended purpose 3 Intended purpose The Spaceplus ­Infusomat® is a transportable volumetric infusion pump which is used in combination with approved infusion lines and accessories. The pump is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids, enteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes of administration include intravenous, intra arterial, subcutaneous, epidural, and enteral. The pump must be considered suitable for the infusion perscription and the route of administration by a qualified medical professional based on the technical data of the pump. The Spaceplus ­Infusomat® is intended to be used by trained healthcare professionals in healthcare facilities, in outpatient and home patient settings, as well as in medical ground and air transport situations (road ambulances, fixed-wing and rotary-wing air ambulances). The user must have received training on the device.

The use of the Spaceplus ­Infusomat® is dependent on the environmental conditions specified in the technical data. The storage conditions are detailed in the technical data. Contraindications are determined by the contraindications of the drug being administered. There are no implied contraindications for the use of the Spaceplus Infusomat®. There are no product specific side effects. Infusion therapy and the use of infusion pumps in general bare several risks: Infusion delivery error and medication error (incl. programming error, medication over- und undersupply, free flow); air infusion leading to air embolism; mechanical hazards (incl. device drop, jamming of fingers); microbial contamination of the infusion pump; electric hazard including thermal hazards; infusion of contaminants into patient; acoustic hazards (by alarms); leaking or disconnection of infusion tube (leading to blood loss, air infusion, micro­ biological contamination and contamination by leaking infusion solution).

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Safety instructions 4 Safety instructions WARNING! Read all the safety instructions before using the device and observe them. 4.1

General use

The device should only be used by trained staff. Training on the device must be given by a person authorised by B. Braun. All serious incidents related to this product must be reported to B. Braun and the competent authority in the country where the product is being used. 4.2

Inspection on delivery

Check the contents of the delivery for ­completeness and damage immediately after unpacking. Transport damage may occur even if the device has been carefully packaged. Do not use damaged devices or cables. Inform a trained technician.

4.3

Before and during use Fully charge the battery before the first use without an external power supply! This extends lifetime of the battery and prevents damage. Check pump and accessories for damage and heavy soiling (especially the air sensor)! Do not use damaged cables!

When switching the pump on – Check that the display is working correctly (e.g. no pixel errors) – Check that the status LEDs are working correctly – Check the alarm signals Observe the expiry date on the packaging for all accessories and disposables!

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Safety instructions When multiple pumps/infusion lines are connected (parallel infusion), mutual interference cannot be ruled out. If the display fails (e.g. touch screen stays dark) while an infusion is in progress (green LED illuminated), do not use the touch screen to operate the pump. Give the pump to a trained technician. 4.4

Cleaning Clean and disinfect the pump before using it with a new patient!

4.5

Protecting patients Disconnect from the patient before inserting or removing infusion lines! Risk of overdose from free flow. If the pump has fallen/ been dropped or has been subjected to another violent impact, do not use it with patients! Have the pump checked by trained technician.

Only use small quantities of cleaning fluid!

Do not move the pump during delivery! A change in height while the infusion is in progress can affect the flow rate.

Protect electrical plugs from excessive moisture!

Risk of inaccurate delivery!

Disconnect from mains power before cleaning!

When administering high risk medications, have a second device ready for the drug. The plausibility of the displayed and transferred data must always be crosschecked by the user before any further medical decisions are taken. It has to be expected that reported data is incomplete. In case of connectivity issues, pump can always programmed at the device.

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Safety instructions Make sure that the infusion lines and cables cannot strangle the patient.

Adequate monitoring of vital signs is required when administering high risk medications. When multiple infusions are administered through the same infusion lines (e.g. concurrent infusions, secondary ­infusions), consider issues related to chemical interactions and incompatibilities of the medication which can potentially result in precipitants and other issues. 4.6

Alarm volume and patient call

Make sure that the alarm volume is high enough! The alarms must be adapted to the physical environment and the ambient noise level. This also applies when using a secondary alarm systems or when connected to a staff call system. Check the staff call after connection and before the first use of the pump! Supervise pump alarms locally at the device unless all devices at the bedside are indicating a successfull connection to a distributed alarm system.

4.7

Setting up the device Set the pump up level!

Attach horizontally to the bracket! Do not secure the pump clamp to the wall rail at the points where the wall rail is attached to the wall. Do not position above a patient! Risk of injury if the pump or its components fall. Position all cables and infusion lines so that they do not present a trip hazard! Avoid unconnected power plug sockets connected to AC voltage. Set up the pump so that the mechanism for disconnecting the mains power is easily accessible (i.e. by unplugging the pump or the mains power plug).

Refer to Instruction for Use ConAct

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Safety instructions Ensure the pumps fully lock in when connecting them. Listen for the click! When using in an inpatient setting, secure a maximum of 3 pumps to each pump clamp.

When using in road and air ambulances only attach one pump to each pump clamp. Ensure single pump is properly placed on a flat surface before attaching fluid bag to short stand and connecting to patient to assure pump cannot fall and harm patient. Use only one infusion bag with max. 1000 ml on the short stand. Do not use the short tripod in road and air ambulances. Secure all pumps and do not rely on stacking mechanism in road and air ambulances! Observe the stability of the IV pole when loaded with devices.

4.8

Device environment Comply with the ­recommended distances (at least 30 cm) to devices with higher interference signals (see section 24). (e.g. electrosurgical equipment, MRI units, mobile phones etc.) Portable and mobile RF communications equipment should not be permanently used closer than 30 cm to any part of the Spaceplus System or it’s components, including cables, e.g. placing a mobile phone directly onto the pump should be avoided as it could lead to a decrease in the device’s performance. Do not use the pump near corrosive or flammable gases. Operate the pump at least 20 cm away from the patient.

Only store and operate the pump within the specified temperature range! (See section 23)

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Safety instructions If the pump has been stored outside the specified operating temperature range, store the pump within the specified temperature range for at least one hour before being powered on. The use of this pump immediately next to other devices or when stacked with other devices should be avoided as this could lead to a malfunction.

4.9

Using the infusion line correctly

It is recommended that disposable items are changed at least after 96 hours (see hygiene rules). Make sure that the line is not kinked.

Nevertheless, if the pump has to be used as described above, it (and the other devices) should be monitored to ensure that they are working correctly. Note: A list of devices that the Spaceplus ­Infusomat® has been tested next to or when stacked with, and which have no effect on the proper operation of the Spaceplus ­Infusomat® when used in the immediate vicinity or when stacked with it, can be found in section 26.3. When using the pump at home, make sure that the pump is not placed next to any heat sources (fireplace, oven, central heater). The pump can be operated at temperatures from 10 … 40°C (50 … 104°F).

4.10 Transporting the device

Always carry by the handle!

Carry a maximum of 3 stacked devices by the handle!

Do not carry by the front flap!

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Safety instructions 4.11 Avoiding damage

to the device

Protect against water and dirt!

4.12 Accessories

Only use together with accessories approved by the manufacturer B. Braun Melsungen AG! Otherwise, function may be impaired. Only accessories, disposables and spare parts that comply with the EU Medical Device Regulation (MDD/MDR), and have the appropriate certification may be used. To ensure B. Braun Spaceplus pumps function correctly, we recommend using B. Braun Melsungen AG accessories. Electrical devices connected to interfaces must meet the requirements of the corresponding IEC specification! (e.g. IEC 60950 for using the staff call)

4.13 Maintenance, servicing

and spare parts

Only use original spare parts! Carry out technical safety check on the pumps. These may only be carried out by trained technicians. If changes are made to the ME device, the appropriate inspections and tests must be carried out to ensure that it is still safe to use. 4.14 Software and updates

Always keep software up to date! Only use the instructions for use that correspond to the software version! Inform yourself of new device functions after software updates! To maintain IT security, software updates might be necessary. Always keep passwords, PINs and other credentials secret; use them according to the policies of your organization! In case you observe or suspect a security problem including B.Braun devices, please contact your B.Braun representative, the B.Braun Product Security Team (­productsecurity@bbraun.com) or visit https://www.bbraun.com/productsecurity. 15

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Safety instructions 4.15 Safety standards

The device meets all of the following safety standards for medical electrical equipment in compliance with: IEC 60601-1:2005 + A1:2012 and IEC 60601-2-24:2012. The EMC (electromagnetic compatibility) limits according to IEC 60601-1-2:2014 and IEC 60601-2-24:2012 are complied with.

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Device overview 5 Device overview Front

5.1

2

3

4

5 6

1

No.

Element

Meaning

1

Pump locking button

2

Brightness sensor Lights up green when the pump is delivering Lights up yellow if there are low priority alarms Lights up red if there are high priority alarms Lights up white if pump is connected to the mains power

3

Home menu    

4

On/off button: also stops the infusion if a delivery is in progress   

5

Stop button

6

Open front door   

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Device overview Back

5.2

6

1

2

3

4

5

No.

Name

1

Guide rails for connecting pumps

2

Cooling element with the option of attaching the Spaceplus Pump Clamp

3

Mains connection (connection for mains power; in the event of mains power failure, the pump automatically switches to battery operation)

4

Accessory port (e.g. staff call, connection for 12 V cable)

5

Infrared interface (communication in Spaceplus Station)

6

Carry handle

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Ports and connections 6 Ports and connections 6.1

Attaching/detaching the pump clamp

Pull the ring of the pump clamp back in order to use the quick-release mechanism and position the clamp on the wall rail/ the infusion stand. The pump clamp will cover a diameter of 20 mm to 40 mm and is compatible to rectangular rails that have shapes of 10x25 mm to 10x35 mm. Release the ring and turn the pump clamp clockwise to secure. Please observe the load capacity of the infusion stand / ceiling unit / wall rail. Attach the pump clamp to the pump as shown in the picture. The pump clamp is safely locked when you hear a clear click.

6.2

Connecting/ disconnecting pumps

Slide the pumps together using the guide rails on the top and bottom of each pump. The pumps have been safely locked in place when you hear a clear click and the locking button on the side of the top pump no longer sticks out. To release the pump lock, press the locking button on the left side of the top pump and slide this pump backwards.

Remove the clamp from the pump and turn the pump clamp 90° to attach the pump to a vertical or horizontal bracket. To release the pump, push the lever on the pump clamp backwards and remove the pump upwards. 19

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Ports and connections 6.3

Connecting cables

6.3.1 Power cable

Plug the power cable into the socket for the mains connection on the back of the pump.

6.4

When the pump is being powered by mains power, the plug symbol on the front of the pump lights up white and a mains plug is shown on the display. 6.3.2 Accessory cable for bolus button

and patient call

Plug the accessory cable for the PCA Handset or the staff call into the accessory port on the back of the pump or at the Cover of the Spaceplus Station when the pump is inserted. The accessory cable is safely connected when you hear a clear click. The PCA Handset can be in physical contact with the patient and may also be operated by the patient as it can only be used to deliver a PCA bolus. Limits for the PCA bolus need to be set to therapeutically sensible and safe values in the drug library.

Short stand SP (8713135)

Use the short infusion stand to attach an infusion container to the pump. Caution! Note that the pump con­ nected to the short infusion stand can only be used on a flat surface and must not be carried by the handle. Only use infusion containers with max. 1000 ml with the short infusion stand. 6.5

Attaching / Removing pump to Lockbox

The usage of the Lockbox is limited to pain medication and not for high risk medications. Attaching the Lockbox 1 |  Position the Lockbox so that the Lockbox slides into the guide rails at the upper side of the pump. 2 |  Open the door to hang up a bag up to a size of 500 mL.

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