Braun SpaceControl User manual

for automated glucose control
Instructions for use
Valid for software I93050A
SpaceControl
g

2
Contents
Contents
1 About this document........................................................................................4
1.1 Purpose ......................................................................................................................... 4
1.2 Additional valid instructions for use .................................................................... 4
1.3 Markings and symbols .............................................................................................. 4
1.4 Abbreviations .............................................................................................................. 4
2 Safety instructions ...........................................................................................5
2.1 Intended use ............................................................................................................... 5
2.2 Safe handling of the device .................................................................................... 5
2.3 Safe application of the automated glucose monitoring ................................ 7
2.4 Other components ..................................................................................................... 8
2.5 Safety standards ........................................................................................................ 8
3 Description of the device .................................................................................9
3.1 Displays and controls ................................................................................................ 9
3.2 Interfaces ...................................................................................................................10
3.3 Symbols on the device ...........................................................................................10
3.4 Application of the automated glucose monitoring .........................................11
3.4.1 Positioning of the device within the SGC system /
compatible components .............................................................................11
3.4.2 Tasks of the device within the SGC system ..........................................12
4 Description of the functions / Operation .................................................... 13
4.1 Screen design ............................................................................................................13
4.1.1 Overview screen (example) .......................................................................14
4.1.2 Display of alarm states ...............................................................................15
4.2 Navigation and input elements ...........................................................................16
5 Menu structure / Overview of functions .................................................... 18
5.1 Main menu ................................................................................................................18
5.2 Nutrition .....................................................................................................................18
5.3 Options........................................................................................................................19
5.3.1 Options > Patient data ...............................................................................19
5.3.2 Options > System Data > System Data .................................................19
5.3.3 Options > System Data > SpaceCom .....................................................20
5.3.4 Options > Conguration SGC ...................................................................20
5.3.5 Options > Conguration SpaceControl .................................................21
5.4 Start / Stop and Overview .....................................................................................21
6 Start-up and self-test................................................................................... 22

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Contents
7 Operation ...................................................................................................... 23
7.1 Starting a new therapy ..........................................................................................23
7.2 Calculation of new suggested values ................................................................26
7.2.1 Hypoglycaemia warning ...........................................................................27
7.2.2 Blood glucose value is not plausible .....................................................27
7.2.3 Error in calculation .....................................................................................27
7.3 Conrming the suggested insulin dose rate / SGC mode.............................28
7.4 Entering the blood glucose value ........................................................................28
7.5 Overruling the insulin dose rate / manual mode ............................................29
7.6 Returning to the SGC mode ..................................................................................30
7.7 Changing the nutrition rate (enteral / parenteral) ........................................30
7.8 Stopping nutrition (enteral / parenteral) / interrupting
for short period ........................................................................................................30
7.9 Entering parenteral bolus ...................................................................................... 31
7.10 Entering a meal ........................................................................................................31
7.11 Enabling standby mode on the device as well as insulin and
nutrition pumps .......................................................................................................32
7.12 Data Lock ...................................................................................................................32
7.13 Displaying the insulin pump settings .................................................................32
7.14 Displaying the nutrition pump settings (enteral / parenteral) ...................33
7.15 Stopping the insulin pump ....................................................................................33
7.16 Ceasing the therapy ................................................................................................34
7.17 Continuing the therapy ..........................................................................................34
7.18 Starting a new therapy after a therapy has been ceased ............................34
7.19 Steps to be taken if the SGC therapy does not start .....................................35
8 Alarms .......................................................................................................... 37
9 Cleaning and care / Disposal ........................................................................ 38
9.1 Cleaning and care ....................................................................................................38
9.2 Disposal ......................................................................................................................38
10 Technical Safety Check (TSC) / Service ....................................................... 39
11 Guarantee ...................................................................................................... 39
12 Technical data ................................................................................................ 40
13 Instructions on electromagnetic compatibility (EMC)............................... 41
14 Order data ...................................................................................................... 43
Contents
1 About this document........................................................................................4
1.1 Purpose ......................................................................................................................... 4
1.2 Additional valid instructions for use .................................................................... 4
1.3 Markings and symbols .............................................................................................. 4
1.4 Abbreviations .............................................................................................................. 4
2 Safety instructions ...........................................................................................5
2.1 Intended use ............................................................................................................... 5
2.2 Safe handling of the device .................................................................................... 5
2.3 Safe application of the automated glucose monitoring ................................ 7
2.4 Other components ..................................................................................................... 8
2.5 Safety standards ........................................................................................................ 8
3 Description of the device .................................................................................9
3.1 Displays and controls ................................................................................................ 9
3.2 Interfaces ...................................................................................................................10
3.3 Symbols on the device ...........................................................................................10
3.4 Application of the automated glucose monitoring .........................................11
3.4.1 Positioning of the device within the SGC system /
compatible components .............................................................................11
3.4.2 Tasks of the device within the SGC system ..........................................12
4 Description of the functions / Operation .................................................... 13
4.1 Screen design ............................................................................................................13
4.1.1 Overview screen (example) .......................................................................14
4.1.2 Display of alarm states ...............................................................................15
4.2 Navigation and input elements ...........................................................................16
5 Menu structure / Overview of functions .................................................... 18
5.1 Main menu ................................................................................................................18
5.2 Nutrition .....................................................................................................................18
5.3 Options........................................................................................................................19
5.3.1 Options > Patient data ...............................................................................19
5.3.2 Options > System Data > System Data .................................................19
5.3.3 Options > System Data > SpaceCom .....................................................20
5.3.4 Options > Conguration SGC ...................................................................20
5.3.5 Options > Conguration SpaceControl .................................................21
5.4 Start / Stop and Overview .....................................................................................21
6 Start-up and self-test................................................................................... 22

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About this document
1 About this document
1.1 Purpose
These instructions for use are part of the device.
 Read these instructions for use before starting up.
 Always keep the instructions for use available with the device.
 Read and observe all additional valid instructions for use.
1.2 Additional valid instructions for use
Instructions for use Information
Perfusor®Space Safe operation of the infusion pump
Infusomat®Space Safe operation of the volumetric pump
SpaceStation Use and removal of the pump and the device
SGC module Mounting of the SGC module onto the device
1.3 Markings and symbols
Marking Meaning
WARNING! Instruction to prevent dangers to the patient or the user
Attention: Instruction to prevent damage to the device or operating
error
Note: Information to better understand or to optimize work
processes
 Handling instruction: You must do something here.
1. Handling instruction for several steps.
2.  Observe the correct order.
Bold print Refers to a navigation or input element
Button > Button  Press the buttons indicated in the order given.
1.4 Abbreviations
Abbreviation Meaning
SGC Space GlucoseControl

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Safety instructions
2 Safety instructions
2.1 Intended use
SGC is a decision supporting system for optimised insulin therapy for critically
ill patients in a closely monitored environment, e. g. intensive care units (ICU)
or operating theatres. Based on the data of patient's glucose level and optional
carbohydrate feeding coming from enteral and parenteral nutrition pumps the
system suggests an insulin dose rate.
The medical expert then decides on the applicability of the insulin dose rate
suggested.
Additional descriptions are contained in these instructions for use.
2.2 Safe handling of the device
 Initial training at the device must be carried out by the sales sta of B. Braun
or another authorised person. The user is instructed to inform himself of the
most recent changes to the device and its additional equipment after each
software update. These details are in the instructions for use.
 Do not use the device in potentially explosive areas such as, in operating
theatres, when ammable anaesthetic gases are used.
 Only use the device under regular control by trained personnel.
 The system must have a sure footing during operation or must be xed by a
suitable tool to a stand or a wall mount.
 The system – especially the terminal block contacts and the connection
cable – and the patient must not be touched simultaneously.
 The device can only be used together with an insulin pump; it does not have
an independent power supply.
 Do not remove the insulin pump above the device. The device would then
loose its power supply and all stored values would be lost.
 If the mains supply fails then the battery from the insulin pump located
above it supplies the device with power. Running the insulin pump on
batteries can therefore shorten the operating time.
 Do not switch o the insulin pump above the device if the mains supply
fails. The device would then loose its power supply and all stored values
would be lost.
 Make sure that the device is correctly positioned and secured. Do not
position the device above the patient.
 Before starting up the device, check for any damages or missing parts.
 Installation in medically used rooms must comply with the appropriate
regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe all
national regulations and deviations from these instructions.

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 Protect the device from moisture.
 If the device is dropped / falls, or subjected to shock, then it must be
checked by the service workshop.
 The device and the patient must not be touched simultaneously.
 If the device is stored in temperature areas below the dened operating
conditions then allow the device to sit for at least one hour at room
temperature before starting it up.
 When used for mobile applications (homecare, transporting patients within
and outside the clinic) secure the device and the insulin pump with the
supplied xing clip and lock the control panel.
 Make sure that the software version on the device is the same as the
software version referred to in these instructions for use (see title page).
 If there are contradictory or dubious values displayed on the device and the
pump, then only those values displayed on the pump are valid.
 Always check the plausibility of the values displayed before making any
further medical decisions.
 Check optical alarms and displays during the self-test.
 The device is subject to special safety measures with regard to
electromagnetic compatibility (EMC). Observe the electromagnetic
compatibility (EMC) instructions during installation and operation
(see Chapter 13, P. 41).
 The device can be inuenced by mobile HF communication equipment
(e.g. mobile phones, radios).
 The device must be operated at a sucient distance from other electrical
devices. An exception to this is operation of the device in a SpaceStation
together with several insulin and nutrition pumps. Otherwise, function in
accordance to the instructions must be checked.
 The use of additional equipment not intended for use with the device may
result in increased emission or a reduction in the immunity of the device.
 The device's functions may be impaired by the use of devices with high
electromagnetic radiation (e.g. mobile / cordless phones, X-ray machines,
HF surgical apparatus). In these cases, the displayed values may be incorrect.
 When using in the environment of devices that may increase emitted
interference (e.g. HF surgical apparatus, MRT, mobile phones), observe the
safety clearances recommended for the device.
Safety instructions

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2.3 Safe application of the automated glucose monitoring
 The SGC system may only be used by persons who have been trained for use
of the system and who are experienced in the insulin therapy of critically ill
patients.
 The values displayed on the system are insucient to make therapeutic or
diagnostic decisions regarding the condition of the patient. The device is
only a tool and does not replace monitoring / control by medical personnel.
 As in all therapies, interactions with other medication must be considered
during insulin therapy with this device.
 Changes of the insulin dose may inuence the potassium level of the patient.
During an insulin therapy it therefore is necessary to regularly check the
potassium level.
 Check whether the entered values really are the same as the displayed
values in order to detect typing errors and to prevent incorrect entries. Only
start infusion when the values are identical.
 The blood glucose measuring device used must be validated for use in an
intensive care unit.
 The insulin and nutrition pumps used in the system can be controlled (and
stopped) at all times from their control panels.
 Entering an incorrect blood glucose value has a long term eect on the SGC
algorithm even if the correct value is subsequently entered. Never enter
incorrect values, e.g. for test purposes. Check all entries carefully before
conrming them.
 When calculating the new suggested values by the SGC algorithm, only the
current rates of the nutrition pumps (enteral / parenteral) contained in the
system are automatically considered. Enter additional parenteral boluses
and feeds for the patient manually at the device.
 When calculating the new suggested values by the SGC algorithm, only
the insulin pump contained in the system is automatically considered. Any
additional administration of insulin is forbidden.
 When treating forms of hypoglycaemia when using the system, always
consider the current state of medical knowledge and the local standards.
 If the insulin pump stops due to a pressure alarm or a syringe change, it is
recommended to reduce the time until the next blood glucose measurement
to the minimum of 30 minutes.
Safety instructions

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2.4 Other components
 Please observe the instructions for use of the other components with regard
to their technical data.
 Possible incompatibilities of devices and drugs are contained in the
respective information from the manufacturer.
 Only use compatible combinations of devices, additional equipment and
wearing parts.
 Connected electrical components must comply with the IEC/EN specication
(e.g. IEC/EN 60950 for data-processing devices). Anyone connecting
additional devices must be system installer and is therefore responsible for
compliance to system standard IEC/EN 60601-1-1.
2.5 Safety standards
 The device meets all safety standards for medical electrical equipment in
compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24.
 EMC thresholds (electromagnetic compatibility) compliant to
IEC/EN 60601-1-2 and IEC/EN 60601-2-24 are observed.
 The device complies with the appropriate requirements of DIN EN 1789 for
use in Medical Vehicles and their equipment.
Safety instructions

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3 Description of the device
3.1 Displays and controls
No. Name / Function
1 Control panel: Display / Touch screen for entries
 Can be released easily with slight pressure and then pulled out; locks
into position when pushed in
  Can be adjusted and locked at various viewing angles
2 Control panel lock / Mouse pen for touch screen entry
 Control panel can be locked and unlocked
  Control panel must be locked during mobile use
 Lock can be pulled out and used as a mouse pen
 Mouse pen must lock in position when inserted to allow the
control panel to be pushed in
3 Blue LED: Lights when SGC mode is active
Description of the device

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3.2 Interfaces
No. Symbol Interface
1 – To insulin pump for power supply and data communication
2 For expansions, e.g. SGC module
3 Without function in this software version
4 – Infrared (IrDA)
3.3 Symbols on the device
Symbol Meaning
Attention! Observe accompanying documents.
Observe disposal instructions.
 Type CF debrillator-protected part
 The device has increased protection against electrical
shock, especially with regard to operating currents
 Protection class II device
 The device does not require an earth conductor
 CE mark compliant to Directive 93/42/EEC
Description of the device

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3.4 Application of the automated glucose monitoring
3.4.1 Positioning of the device within the SGC system / compatible components
Note: Mounting of the SGC module onto the device is described in the
instructions for use of the SGC module. Insertion of the nutrition pump and
the combination of insulin pump, device and SGC module is described in
the instructions for use of the SpaceStation. The SGC module can also be
subsequently assembled onto the device used. A maximum of one parenteral and
one enteral nutrition pump are included in the SGC therapy. If there are further
nutrition pumps in the system, a corresponding note is issued.
The SGC system is comprised of the following components:
No. Component Comment:
1 SpaceStation with or A maximum of 6 SpaceStations can
without SpaceCom be connected to each other.
2 Enteral nutrition pump Positioning at any slots in the
3 Parenteral nutrition pump
SpaceStation (maximum of 24 pumps).
A maximum of one enteral and
one parenteral nutrition pump
are included in the SGC therapy.
Additional nutrition pumps are
recognised but not included.
4 Insulin pump As a combination at any slots in the
5 SpaceControl SpaceStation. Only one SpaceControl
6 SGC module is allowed in the SpaceStation.
Note: A combination of insulin pump, SpaceControl and SGC module can also be
operated without SpaceStation as the minimum conguration for insulin therapy.
Description of the device
1
2
3
4
5
6

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Only the following components are compatible with each other as of the
software versions specied:
Component Software version
SpaceStation Not relevant
SpaceCom 695J
Perfusor®Space 688J
Infusomat®Space 686J, 687J
SpaceControl I93050A
SGC module I93070A
3.4.2 Tasks of the device within the SGC system
The device automatically collects the information from the insulin pump and the
nutrition pumps (e.g. history and current infusion status) and additional data
from meals and blood glucose measurements, displays the current delivery rates
and provides the user interface for SGC therapy.
Parameters relevant to therapy, as well as the course of therapy, are shown on
the display. All entries are made on the touch screen.
The device carries out alarm and time monitoring until the next blood glucose
measurement.
The device initiates new calculations of the insulin dose rate using the SGC
algorithm in the SGC module.
The user is responsible for operation of the insulin pump. He / She must conrm
the suggested insulin dose rate and also make all settings relevant to the therapy
(e.g. start, stop, setting of the rate).
The settings can be made on the touch screen of the device or via the control
panel of the pump.
Description of the device

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4 Description of the functions / Operation
Note: The basic functions of the individual displays and controls are described in
the following section. These are not visible at all times.
Depending on the current software version, individual items on the displays on the
screen may be slightly dierent from the pictures shown in these instructions for
use.
The colours shown may be dierent depending on the settings at the device.
4.1 Screen design
No. Name / Function
1 Navigation window
 Contains buttons for calling up menus or to initiate actions
2 Control window
 Contains menus with the appropriate controls and displays
  Automatically displays the overview screen if no menu is overlaid during
therapy (see Chapter 4.1.1, P. 14)
3 Status window

Displays status information of the insulin pump, e.g. battery capacity,
delivery rate, date and time (for additional information, see separate
instructions for use)
4 Information window
 Displays explanations on the content of the Control window
 Displays alarm states (see Chapter 4.1.2, P. 15)
 To enlarge (zoom out) the Information window: Press the Info button in
the Navigation window.
Description of the functions / Operation

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4.1.1 Overview screen (example)
WARNING! If there are contradictory or dubious values displayed on the
device and the pump, then only those values displayed on the pump are valid.
The overview screen is displayed:
 Automatically if no menu has been overlaid during therapy
 Automatically 30 s after the last entry
 During therapy if the Overview button is pressed in the Navigation window
No. Display / Function
1 Name of the insulin drug used (text colour of the drug library can be
congured)
2 Time until next blood glucose measurement
3 Last measured blood glucose value
  Press button to enter a new blood glucose value.
4 Previous blood glucose values and insulin dose rates in a time curve, and
intended insulin dose rate until the next blood glucose measurement
5 Nutrition pumps delivery rates
6 Insulin pump delivery rate
7 Current insulin dose rate optionally with Softlimit symbol as in the display
of the insulin pump (text colour as for No. 1).
Description of the functions / Operation

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4.1.2 Display of alarm states
Note: The alarms from the individual system components are basically retained
active (for a description, see separate instructions for use).
Additionally, alarms are displayed by changing the colour of the Information
window and the frame colour of the Control window:
Yellow: Reminder alarm / Prealarm
Red: Operating alarm
Note: Specic alarms for the SGC therapy (see Chapter 8, P. 37) must be
acknowledged with the button or at the insulin pump to be able to continue
to make entries.
Reminder alarms for incomplete entries at the insulin pump and at the
SpaceControl can be acknowledged by pressing anywhere on the touch screen.
Description of the functions / Operation

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4.2 Navigation and input elements
WARNING! Only use menu or command buttons that are described in
these instructions for use.
Menu buttons
 For navigation (in this example,
blue)
 The menu button pressed in each
case is marked by a white border
(in this example, black)
Command buttons
  To select a parameter and change
its value in the Input window (in
this example, yellow)
 To display the value of a parameter
(in this example, brown)
  To display additional command
buttons:
Press the or button.
Input window
  To change / conrm the value of a
parameter
 Displays the permissible value
range of the parameter (in this
example, 18..720)
 May contain additional command
buttons (in this example, Test
Time)
Note: If no entry is made within
20 s then a yellow reminder alarm
appears.
Description of the functions / Operation

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Description of the functions / Operation
Numeric keypad
 To enter digits / numbers
 To delete and re-enter a value
already entered: Press the C
button.
 To quit the Input window
without changing the value:
Press the button.
 To accept the entry:
Press the OK button.
Alphanumeric keypad
 To enter characters and digits /
numbers
 To select one of the keypad
congurations: Press the
respective button repeatedly
(similar to when entering text
messages on a mobile phone).
 To switch between lower and
upper case: Press the ABC | abc
button.
 To move the cursor: Press the
or button.
 To delete an entry: Press the
button.
 To quit the Input window
without changing the value:
Press the button.
 To accept the entry:
Press the OK button.

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5 Menu structure / Overview of functions
5.1 Main menu
Menu Purpose See
Infusion  Displaying the insulin pump settings. P. 32
Settings  Change the insulin dose rate.
Blood Glucose  Enter blood glucose value. P. 28
 Correct time of blood glucose
measurement.
 Display or reduce time until next blood glucose
measurement.
 Change last entered blood glucose value if
incorrect.
The value is cleared in the SGC algorithm but
remains in the documentation.
Status  Display information on the course of therapy.
 Delete intermediate value (dosage / volume / time).
 Display battery capacity of insulin pump.
Special  Switch SGC mode on or o. –
Functions >
SGC Mode
5.2 Nutrition
Menu Purpose See
Enteral
Nutrition
 Displaying the nutrition pump settings
(enteral / parenteral): Drug, delivery rate,
concentration and supply of carbohydrate.
P. 33
Parenteral
Nutrition
Parenteral
Bolus
 Entering parenteral bolus, e.g. glucose injection,
after hypoglycaemia. Enter the volume
referenced to the nutritional drug or amount of
carbohydrates.
 Enter the moment of the bolus administration.
P. 31
Meal  Enter additional meal.
 Enter the moment of the meal administration.
P. 31
Menu structure / Overview of functions

19
5.3 Options
Menu Purpose See
Patient Data  Display therapy-relevant patient data. P. 19
Standby  Enabling standby mode on the device as well
as insulin and nutrition pumps.
P. 32
System Data  Display and modify system data.
 Export therapy data to an external data
medium.
P. 19
Conguration
SGC
 Set therapy-relevant parameters. P. 20
Conguration
SpaceControl
 Set and display device-specic parameters. P. 21
5.3.1 Options > Patient Data
Parameter Purpose See
ID  Display patient ID.
 Only active during running SGC therapy.
–
Weight  Display the patient weight.
 Only active during running SGC therapy.
–
5.3.2 Options > System Data > System Data
Note: Adjusting the time or the date may result in the time until the next blood
glucose measurement being reduced or to a running SGC therapy being aborted.
Parameter Purpose See
Time  Display and set time. –
Date  Display and set date. –
Menu structure / Overview of functions

20
5.3.3 Options > System Data > SpaceCom
Parameter Purpose See
Documentation  Select a therapy stored in the SGC module for
documentation (for additional information, see
separate instructions for use).
 Values: #1 (current SGC therapy) … #21
(oldest SGC therapy)
–
Transfer  Start data transfer to SpaceCom.
From SpaceCom, the data can be stored on a
USB ash drive (for additional information, see
separate instructions for use).
–
5.3.4 Options > Conguration SGC
Parameter Purpose See
Target  Set the target area of the blood glucose
(requires the entry of the SGC code).
–
Hypoglycaemia  Set threshold for hypoglycaemia warning
(requires the entry of the SGC code).
–
Gluc. Unit  Set unit for blood glucose value. –
Gluc. Color  Set colour of blood glucose value in main
screen.
–
Menu structure / Overview of functions