SpaceControl for automated glucose control

Transcription

1 SpaceControl for automated glucose control Instructions for use g Valid for software I9305_C

2 Contents Contents 1 About this document Purpose Additional valid instructions for use Markings and symbols Abbreviations Safety instructions Intended use Safe handling of the device Safe application of the automated glucose monitoring Other components Safety standards Description of the device Displays and controls Interfaces Symbols on the device Application of the automated glucose monitoring Positioning of the device within the SGC system / compatible components Tasks of the device within the SGC system Description of the functions / Operation Screen design Overview screen (example) Display of alarm states Navigation and input elements Menu structure / Overview of functions Main menu Nutrition Options Options > Patient data Options > System Data > System Data Options > System Data > SpaceCom Options > Configuration SGC Options > Configuration SpaceControl Start / Stop and Overview Start-up and self-test

3 Contents 7 Operation Starting a new therapy Calculation of new suggested values Hypoglycaemia warning Blood glucose value is not plausible Error in calculation Confirming the suggested insulin dose rate / SGC mode Entering the blood glucose value Overruling the insulin dose rate / manual mode Changing the insulin dose rate at the pump / manual mode Returning to the SGC mode Changing the nutrition rate (enteral / parenteral) Stopping nutrition (enteral / parenteral) / interrupting for short period Entering parenteral bolus Entering a meal Enabling standby mode on the device as well as insulin and nutrition pumps Data Lock Displaying the insulin pump settings Displaying the nutrition pump settings (enteral / parenteral) Stopping the insulin pump Ceasing the therapy Continuing the therapy Starting a new therapy after a therapy has been ceased Steps to be taken if the SGC therapy does not start Alarms Cleaning and care / Disposal Cleaning and care Disposal Technical Safety Check (TSC) / Service Guarantee Technical data Instructions on electromagnetic compatibility (EMC) Order data

4 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 Perfusor Space Infusomat Space SpaceStation SGC module 1.3 Markings and symbols Marking WARNING! Attention: Note: Information Safe operation of the infusion pump Safe operation of the volumetric pump Use and removal of the pump and the device Mounting of the SGC module onto the device Meaning Instruction to prevent dangers to the patient or the user Instruction to prevent damage to the device or operating error 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 Button > Button Refers to a navigation or input element Press the buttons indicated in the order given. 1.4 Abbreviations Abbreviation SGC Meaning Space GlucoseControl 4

5 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 staff 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 flammable 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 fixed 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 off 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. 5

6 Safety instructions 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 defined 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 fixing 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 influenced by mobile HF communication equipment (e.g. mobile phones, radios). The device must be operated at a sufficient 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. 6

7 Safety instructions 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 insufficient 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 influence 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 effect 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 confirming 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. 7

8 Safety instructions 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. It is recommended to use insulin infusion lines of adequate material in order to avoid saturation effects of the infusion line material. Connected electrical components must comply with the IEC/EN specification (e.g. IEC/EN for data-processing devices). Anyone connecting additional devices must be system installer and is therefore responsible for compliance to system standard IEC/EN Safety standards The device meets all safety standards for medical electrical equipment in compliance with IEC/EN and IEC/EN EMC thresholds (electromagnetic compatibility) compliant to IEC/EN and IEC/EN are observed. The device complies with the appropriate requirements of DIN EN 1789 for use in Medical Vehicles and their equipment. 8

9 Description of the device 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 9

10 Description of the device 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 defibrillator-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 10

11 Description of the device 3.4 Application of the automated glucose monitoring 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 configuration for insulin therapy. 11

12 Description of the device Only the following components are compatible with each other as of the software versions specified: Component Software version C SpaceStation Not relevant SpaceCom 695J, L or greater Perfusor Space 688J, L, M, N, P Infusomat Space 686J, L, M, N, P 687J, L, M, N, P SpaceControl I9305_C SGC module I9307_B 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 confirm 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. 12

13 Description of the functions / Operation 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 different from the pictures shown in these instructions for use. The colours shown may be different 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. 13

14 Description of the functions / Operation 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 configured) 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). 14

15 Description of the functions / Operation 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: Specific 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. 15

16 Description of the functions / Operation 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 / confirm the value of a parameter Displays the permissible value range of the parameter (in this example, ) 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. 16

17 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 configurations: 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. 17

18 Menu structure / Overview of functions 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. Correct last entered blood glucose value if incorrect. The value is cleared in the SGC algorithm but remains in the documentation. Recalculate insulin dose rate to change from manual mode to SGC-mode. 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 off. Functions > SGC Mode 5.2 Nutrition Menu Purpose See Enteral P. 33 Nutrition Parenteral Nutrition Displaying the nutrition pump settings (enteral / parenteral): Drug, delivery rate, concentration and supply of carbohydrate. Parenteral Bolus Meal 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. Enter additional meal. Enter the moment of the meal administration. P. 31 P

19 Menu structure / Overview of functions 5.3 Options Menu Purpose See Patient Data Display therapy-relevant patient data. P. 19 Standby Enabling standby mode on the device as P. 32 well as insulin and nutrition pumps. System Data Display and modify system data. P. 19 Configuration Set therapy-relevant parameters. P. 20 SGC Configuration Set and display device-specific parameters. P. 21 SpaceControl 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 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. 19

20 Menu structure / Overview of functions 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 flash drive Delete all therapies In order to delete all therapy history data, the question "Do you want to delete all therapy data?" has to be confirmed. Note: This feature is during a running therapy inactive Options > Configuration SGC Parameter Purpose See Target Set the target 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. Maximum Interval Blood glucose measurement interval can be limited to 1, 2 or 3 hours (requires the entry of the SGC code). 4 hours is the default setting and is the maximum interval time for blood glucose measurement. 20

21 Menu structure / Overview of functions Options > Configuration SpaceControl Menu Purpose See Graphic Display and change future and history settings in overview screen. Set colour of drug in overview screen. Display Set brightness, contrast, colour set and key panel beep. Disable touch screen function for cleaning. P. 38 Service / Diagnosis Display device settings, e.g. language, software version. Only accessible to technical service (password protected). Note: Inactive during current SGC therapy. 5.4 Start/Stop and Overview Button Purpose See Start Start insulin pump. After pressing the button, the display changes to the Stop and Overview buttons. Stop Stop insulin pump. P. 33 Overview Call up the overview screen for the course of the therapy. P

22 Start-up and self-test 6 Start-up and self-test The device itself cannot be switched on and off. It is switched on and off via the insulin pump or alternatively its power supply. The device runs a self-test immediately after start-up. Note: In normal system operating condition, i.e. completely assembled, mains plug inserted and insulin pump switched on, the device is already switched on; the following description of the self-test has therefore normally been completed. Display during the course of the self-test The self-test runs successfully if the following conditions are met in the display: The status bar is completely full. The switch-on screen with version and colour test fields is evident. Display after successful self-test A pause screen is displayed with the message that the device is waiting to connect to other components. The pause screen is displayed until the requirements to start therapy have been met (see Chapter 7, P. 23). Measures to be taken if self-test is unsuccessful Submit the device to the technical service. 22

23 Operation 7 Operation 7.1 Starting a new therapy To start the therapy on the system, the following requirements must be met (for additional information, see separate instructions for use): The SGC module must be connected to the device and operational, i.e. the green LED lights. The nutrition pumps are using the drug library. A drug has been selected at the nutrition pumps that has been approved for use as a SGC nutrition drug. The insulin pump is switched on and is not in standby mode. The insulin pump is in continuous mode, i.e. no other therapy such as PCA, TCI is active. The insulin pump is using the drug library. A drug has been selected at the insulin pump that has been approved for use as a SGC insulin drug. The concentration of the drug is 100 IU/ml. The insulin pump is not protected against entries by Data Lock Level 3 The insulin pump is not in KVO mode Note: It may take a few seconds to establish a connection and to transfer the parameters from the pumps. 1. Press On to confirm the SGC mode. 23

24 Operation 2. Enter weight of patient and confirm with OK. 3. To enter the patient ID when required: Press the ID button. Enter the patient ID and confirm with OK. 4. Check all the parameters. The profile symbol for SGC is displayed on the display of all pumps in the system. The blue LEDs light up on the device and on the insulin pump. 5. Confirm correct parameters with Yes. Note: If nutritional therapy has already been started, set the nutrition pumps within the system to the appropriate rates and drugs before entering the first blood glucose values and then switch on. This allows the nutritional data to be included in the first calculation of the insulin dose rate. Attention: The blood glucose measuring device used must be validated for use in an intensive care unit. 24

25 Operation WARNING! Entering an incorrect blood glucose value has a long term effect on the SGC algorithm even if the correct value is subsequently entered. Never enter incorrect values, e.g. for test purposes. Check all the entries carefully before confirming them. If necessary, correct an incorrect value with Correct last value. 6. Enter the blood glucose value. 7. To correct the displayed time of the blood glucose measurement that was taken, if necessary: Press Test time. Change the value and confirm with OK. 8. Confirm blood glucose value with OK. The new suggested values are calculated (see Chapter 7.2, P. 26). 9. Confirm the suggested insulin dose rate (see Chapter 7.3, P. 28). The insulin dose rate is set at the insulin pump. 10. Press Start to start the infusion at the insulin pump. The overview screen is displayed. 25

26 Operation 7.2 Calculation of new suggested values The following events result in calculation of the new suggested values by the stored SGC algorithm: Blood glucose value entered (see Chapter 7.4, P. 28) Current rate of nutrition pump (enteral / parenteral) is changed (see Chapter 7.7, P. 30) Nutrition pump (enteral / parenteral) is stopped (see Chapter 7.8, P. 30) Parenteral bolus entered manually (see Chapter 7.9, P. 31) Meal entered manually (see Chapter 7.10, P. 31) Standby mode is exited (see Chapter 7.11, P. 32) Recalculate insulin dose rate Display in the course of the calculation The following suggested values are calculated: Insulin dose rate Time of next blood glucose measurement Display after successful calculation The suggested values are displayed after successful calculation. In the top area of the screen, the values upon which the calculation was based are displayed. An arrow indicates the value that has been changed. In case of additional meals and parenteral boluses, no arrow is displayed and there is therefore no change in the nutritional data. 26

27 Operation Confirm the suggested insulin dose rate (see Chapter 7.3, P. 28). -or- Suggested insulin dose rate fits (see Chapter 7.5, P. 29). Note: The suggested time until the next blood glucose measurement can be reduced Hypoglycaemia warning The blood glucose value entered is less than or equal to the preset threshold. 1. Observe instructions in the display. 2. Confirm the message with OK. The calculated suggested values are displayed (see Chapter 7.2, P. 26). 3. Confirm the suggested insulin dose rate. Note: If no parenteral bolus is entered within 10 minutes, a yellow reminder alarm is displayed. 4. In case of glucose injection to treat hypoglycaemia: Enter the parenteral bolus (see Chapter 7.9, P. 31) Blood glucose value is not plausible The SGC algorithm has classified the entered blood glucose value as implausible. Correct the blood glucose value (see Chapter 7.4, P. 28). or Accept the blood glucose value. The calculated suggested values are displayed (see Chapter 7.2, P. 26) Error in calculation An error has occurred in the calculation. 1. Observe instructions in the display. 2. If necessary, check the insulin dose rate. 3. Confirm the message. The system changes to manual mode. The time until the next blood glucose measurement is set to the minimum of 30 minutes. 27

28 Operation 7.3 Confirming the suggested insulin dose rate / SGC mode Requirement: Calculation of the new suggested values carried out successfully (see Chapter 7.2, P. 26). Note: If the entry is not made within 5 minutes, a red operating alarm is displayed and the SGC therapy is ceased. 1. To reduce the suggested time until the next blood glucose measurement: Press Measure in. Change the value and confirm with OK. 2. Confirm the suggested insulin dose rate. The insulin dose rate is set at the insulin pump. The overview screen is displayed. 3. Press Start to start the insulin pump. 7.4 Entering the blood glucose value Attention: The blood glucose measuring device used must be validated for use in an intensive care unit. WARNING! Entering an incorrect blood glucose value has a long term effect on the SGC algorithm even if the correct value is subsequently entered. Never enter incorrect values, e.g. for test purposes. Check all the entries carefully before confirming them. If necessary, correct an incorrect value with Change last value. 1. In the overview screen, press Blood Glucose. or Press Main menu > Blood Glucose > Blood Glucose. 2. Enter the blood glucose value. 3. To correct the displayed time of the blood glucose measurement that was taken: Press Measure in. Change the value and confirm with OK. 4. Confirm blood glucose value with OK. The new suggested values are calculated (see Chapter 7.2, P. 26). Note: After the input of a new blood glucose value, it is impossible to press the blood glucose button for 15 min. Within these 15 min., it is only possible to use Correct last value. You can reach this button using Main menu -> Blood Glucose 28

29 Operation 7.5 Overruling the insulin dose rate / manual mode Requirement: Calculation of the new suggested values carried out successfully (see Chapter 7.2, P. 26). Note: If the entry is not made within 5 minutes, a red operating alarm is displayed and the SGC therapy is ceased. 1. Press Dose Rate. 2. Change the value and confirm with OK. Note: If the entered value lies outside the defined Hardlimits of the pump or outside the Softlimits for the insulin drug, a corresponding message is displayed here. Only the Softlimits can be exceeded by confirming the message with Yes. 3. Confirm the changed insulin dose rate. The insulin dose rate is set at the insulin pump. After confirmation, the system changes to manual mode. The time until the next blood glucose measurement is set to the minimum of 30 minutes. The manual mode is displayed in the overview screen by the following symbol: In addition to the insulin dose rate, Abb.1 a hand symbol is also shown. The SGC profile symbol for manual mode is displayed. Note: As long SGC is operated in manual mode all changes of the insulin dose rate are taken over without further notification Changing the insulin dose rate at the pump / manual mode You can change the insulin dose rate at the pump at any time. - Enter into the dose rate editor at the pump - Change the dose rate and confirm with OK 29

30 Operation At SpaceControl you will see the following screen: After confirmation, the system changes to manual mode. The time until the next blood glucose measurement is set to the minimum of 30 minutes. The manual mode is displayed in the overview screen by the following symbol: In addition to the insulin dose rate, a hand symbol is also shown. The SGC profile symbol for manual mode is displayed. Note: As long SGC is operated in the manual mode all rate changes will be taken over without further notification. 7.6 Returning to the SGC mode 1. In the overview screen, press Blood Glucose. or Press Main menu > Blood Glucose. 2. Enter a new value. This can be a new blood glucose value or a correction of the last entered glucose value. The new suggested values are calculated (see Chapter 7.2, P. 26). 3. Confirm the suggested insulin dose rate. The insulin dose rate is set at the insulin pump. The system changes to the SGC mode. The overview screen is displayed. 4. Press Start to start the insulin pump. Note: If you want to return to SGC mode without entering a new blood glucose value, please select "Recalculate insulin dose rate" in the blood glucose menu. In this case, last entered blood glucose value is used for calculation. 30

31 Operation 7.7 Changing the nutrition rate (enteral / parenteral) 1. Change the rate at the respective nutrition pump (enteral / parenteral) (see separate instructions for use). The new suggested values are calculated (see Chapter 7.2, P. 26). 2. Confirm the suggested insulin dose rate (see Chapter 7.3, P. 28). or Suggested insulin dose rate fits (see Chapter 7.5, P. 29). 7.8 Stopping nutrition (enteral / parenteral) / interrupting for short period Note: If no entry or action has been carried out within 5 minutes (e.g. replacement of disposables), then the new suggested values are recalculated. 1. Stop the respective nutrition pump (enteral / parenteral) manually (see separate instructions for use). 2. Observe instructions in the display. 7.9 Entering parenteral bolus Making the entry via drug and volume administered 1. Press Nutrition > Parenteral Bolus. 2. Using the or button, select the carbohydrate drug and confirm with OK. 3. Enter volume administered and the time (if necessary) of the bolus and confirm with OK. The new suggested values are calculated (see Chapter 7.2, P. 26). Entry via amount of carbohydrate 1. Press Nutrition > Parenteral Bolus. 2. Select drug Others. 3. Enter amount of carbohydrate and the time (if necessary) of the bolus and confirm with OK. The new suggested values are calculated (see Chapter 7.2, P. 26) Entering a meal 1. Press Nutrition > Meal. 2. Enter the estimated amount of carbohydrate and the time (if necessary) of the meal and confirm with OK. The new suggested values are calculated (see Chapter 7.2, P. 26). 31

32 Operation 7.11 Enabling standby mode on the device as well as insulin and nutrition pumps In case of longer interruptions, the values set at the device and on the pumps can be maintained. Note: It is recommended that standby mode for the pumps be enabled via the device. 1. Press Options > Standby. Carry out the instructions in the display. Note: To cancel standby mode, please follow the instructions in the display. After deactivation of Standby (press the C-Button at the pump and confirm the question on SpaceControl with YES) you are directly forwarded into the menu for blood glucose entry. 2. Enter a blood glucose value 3. Press Start Attention: In case you start SGC without entering a glucose value (Start button on SpaceControl) SGC will continue in the manual mode. Note: After 15 minutes a pre-alarm to enter a new blood glucose value will be given. Confirming this without entering a value an additional alarm will rise after 10 minutes. Now you have 5 minutes left to enter a value before SGC will stop operation Data Lock The device follows the same Data Lock settings as the connected insulin pump (see separate instructions for use) Displaying the insulin pump settings 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 data can only be correctly recognised when the following requirements have been fulfilled (see separate instructions for use): The insulin pump is in correct operation. The insulin pump is using the drug library. Press Main menu > Infusion Settings. Note: Here the insulin dose rate can be changed and thus changed to the manual mode (see Chapter 7.5, P. 29). 32

33 Operation 7.14 Displaying the nutrition pump settings (enteral / parenteral) 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 data can only be correctly recognised when the following requirements have been fulfilled (see separate instructions for use): The nutrition pumps are in correct operation. The nutrition pumps are using the drug library. A drug has been selected at the nutrition pumps that has been approved for use as a SGC nutrition drug. To display the settings of the enteral nutrition pump: Press Nutrition > Enteral Nutrition. To display the settings of the parenteral nutrition pump: Press Nutrition > Parenteral Nutrition Stopping the insulin pump Attention: If the infusion 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. Press Stop If the dose rate exceeds 10 IU/h, an additional message to check the potassium concentration is displayed. Main menu > Special Functions is displayed. In case syringe holder is opened in order to change the disposable, carry out the intructions in the display. 33

34 Operation 7.16 Ceasing the therapy 1. Press Main menu > Special Functions > SGC Mode > Off. 2. Switch off the insulin pump or enable the standby mode (see separate instructions for use) Continuing the therapy The therapy can be continued, for example after standby or a restart of the system if the following requirements are met: It is the same patient, i.e. the current patient and the patient ID stored in the SGC therapy data, as well as the body weight, are identical. The duration of the interruption was < 1 h. 1. Terminate the standby mode at the insulin pump. 2. Press Main menu > Special Functions > SGC Mode > On. 3. Carry out the instructions in the display Starting a new therapy after a therapy has been ceased 1. Start a new therapy at the insulin pump (see separate instructions for use). 2. Press Main menu > Special Functions > SGC Mode > On. 3. Enter the weight of the patient and patient ID if necessary. 4. Check all the parameters. 5. Confirm correct parameters with Yes. 6. Enter the blood glucose value (see Chapter 7.4, P. 28). 34

35 Operation 7.19 Steps to be taken if the SGC-Therapy does not start The following window appears: It is not possible to start the SGC-Therapy. Insulin pump: pump not found or communication problems pump has incorrect software version pump is switched off pump already running with another therapy the date set in the pump is incorrect pump is on standby pump running in KVO operation unknown patient weight Data lock Level 3 is active incorrect Hardlimit for dose rate the preset drug is not suitable for SGC incorrect insulin concentration (>100 IE/ml) SpaceControl: SGC module not found or communication problems SGC module has incorrect software version For further information refer to the SGC manual under Error message (Troubleshooting) Then depending on the error message check the following: is the insulin pump connected correctly to SpaceControl and the SGC module (the insulin pump must be positioned directly above SpaceControl, the connector between SpaceControl and the SGC module must not be damaged and must be plugged into the SGC module), is the pump switched on correctly and has insulin been selected from the drug database, or set up the insulin pump, switch it on again and make a note of the correct software version (688J or 688L) when it starts up. when switching on the pump, the self-test will be carried out and the pump s software version (688J or 688L) is displayed. If the pump is switched off, press the o button on the insulin pump to switch it on. Has the pump been started with another drug other than insulin 35

36 Operation That no other therapy other than SGC is activated. SGC is shown in the display on the insulin pump. The current therapy must be ended before SGC can be started. That the correct date has been set. To do this, go to Menu -> Options -> Date. Enter today s date and confirm by pressing K If the pump is in standby mode, press the "C" button on the pump. This will take it off standby mode. If "the pump is running in KVO mode" appears, then stop KVO mode by pressing the stop button and if necessary select insulin specified for SGC therapy. Has the patient s weight been entered? If not, then enter the patient s weight in SpaceControl, so that the SGC therapy can be started Is the pump in Data Lock 3 mode? In this instance, deactivate Data Lock 3 mode by selecting the "Off" function in Menu -> Options-> Data lock, confirm by pressing K, then enter the code for Data Lock 3 and confirm by pressing K again. The proposed insulin value is lower than the minimum rate for the pump. Arrange for a technician to set the minimum rate to 0.1 ml or lower. Also check: that an SGC drug has been selected, that the insulin concentration is not set higher than 100 IE/ml, that SGC module is present under SpaceControl, SpaceControl is connected to the SGC module, that the cable between SpaceControl and the SGC module is not damaged, the blue control LED is lit on SpaceControl and the green control LED is lit on the SGC module If these steps do not resolve the problem in question, contact a service technician for assistance. 36

37 Alarms 8 Alarms Note: The alarms from the individual system components are basically retained active (for a description, see separate instructions for use). Note: An alarm can be confirmed either at the device with the button or at the insulin pump. The following alarms may occur during a therapy: Alarm Operating alarm, SGC end Prealarm, blood glucose measurement Reminder alarm hypoglycaemia Cause and corrective measure The SGC therapy currently running cannot be continued. Continue the therapy (see Chapter 7.17, P. 34). The time for the next blood glucose measurement has been exceeded. Confirm the alarm with the button or at the pump. Measure and enter the blood glucose value (see Chapter 7.4, P. 28). Note: After confirmation of the first pre-alarm a second pre-alarm will rise 15 minutes later. Confirming this pre-alarm an additional reminder will rise 10 minutes later. Now you have 5 minutes to enter a value before SGC will stop. A parenteral bolus has not been entered within 10 minutes after an hypoglycaemia alarm. Confirm the alarm with the button or at the pump. In case of glucose injection to treat hypoglycaemia: Enter the parenteral bolus (see Chapter 7.9, P. 31). 37

38 Cleaning and care / Disposal 9 Cleaning and care / Disposal 9.1 Cleaning and care Clean device with a mild soap. Do not use disinfectant sprays at the electrical connections. Recommendation: Use disinfectant agent for wiping disinfection from B. Braun (e.g. Meliseptol). Allow to evaporate for at least 1 minute before operation. Do not spray into the device's openings (e.g. openings for required cooling, mains inlet, interfaces). Observe hygiene regulations. Regularly check plug connectors and contacts for dirt (e.g. overflow of liquids), and clean if necessary. WARNING! When cleaning, the system must be disconnected from the mains for safety reasons. To clean the touch screen: Press Options > Configuration SpaceControl > Display > Cleaning > Yes, in order to deactivate the touch screen function for 30 s. The remaining time until reactivation is displayed. Only wipe off the touch screen using a soft cloth. Do not use Hexaquart. 9.2 Disposal Return the device to B. Braun for disposal. When disposing of the device on location, observe the national regulations. 38

39 Technical Safety Check (TSC) / Service 10 Technical Safety Check (TSC) / Service The device must be subjected to a Technical Safety Check (TSC) every two years and the results must be entered in the medical products log according to the check list. Service work may only be carried out by personnel instructed by B. Braun. 11 Guarantee B. Braun provides 24 months guarantee on all devices from date of delivery. This guarantee includes repairs or replacements of defective parts caused by faults in design, fabrication or material. The guarantee becomes invalid if the user or a third party makes independent changes or repairs to the device. Excluded from the guarantee: Remedying of faults caused as a result of faulty operation, improper handling or normal wear. 39

40 Technical data 12 Technical data Device type Control monitor for B. Braun Space Product classification Compliant to Directive 93/42 EEC: Class IIb Conforming to EN : Protection class II For Type CF defibrillator-protected parts IP 21 moisture protection (drip-proof when used on the horizontal) No AP or APG classification Operated continuously Conforming to EN : Class B Cooling method Convection Power supply Via the Perfusor Space insulin pump Power consumption Typ. 4 VA Interfaces Interface to pump Interface to SGC module Display / Input 5.7" colour LCD, LED for connection display / touch screen Operating conditions: Temperature Relative humidity Atm. pressure Storage conditions: Temperature Relative humidity Atm. pressure Weight Dimensions (W x H x D) Technical Safety Check (TSC) Disposal C 30%... 90% (without condensation) mbar C 10%... 90% (without condensation) mbar Approx. 0.9 kg Approx. 210 x 145 x 65 mm Every 2 years By manufacturer or compliant to local regulations 40

41 Instructions on electromagnetic compatibility (EMC) 13 Instructions on electromagnetic compatibility (EMC) Guidelines and declaration of the manufacturer Electromagnetic emissions The device has been designed for use in an electromagnetic environment as listed below. The customer or the user of the device should make sure that it is only operated in such an environment. Emission measurements Compliance HF emissions according to CISPR 11 Group 1 Electromagnetic environment Guidelines The device uses HF energy exclusively for its internal functions. Its HF emission is therefore very low and it is improbable that adjacent electronic devices will be disturbed. HF emissions according to CISPR 11 Emission of harmonics according to IEC Class B Class A The device is suitable for use in all facilities, including those in living areas and those directly connected to a public network that also supplies buildings used for residential purposes. Emission of voltage fluctuations / flicker according to IEC Complies Guidelines and declaration of the manufacturer Electromagnetic immunity The device has been designed for use in an electromagnetic environment as listed below. The customer or the user of the device should make sure that it is only operated in such an environment. Immunity tests IEC test level Compliance level Electromagnetic environment Guidelines Discharge of static electricity (ESD) according to IEC Fast transient electrical disturbances / bursts according to IEC Surges according to IEC Voltage drops, short-term interruptions and fluctuations of supply voltage according to IEC Magnetic field of supply frequency (50/60 Hz) according to IEC ±6 kv contact discharge ±8 kv air discharge ±2 kv for mains lines ±1 kv for input and output powers ±1 kv voltage outer conductor outer conductor ±2 kv voltage outer conductor earth < 5% U T (> 95% interruption of U T) for ½ period 40% U T (60% interruption of U T) for 5 periods 70% U T (30% interruption of U T) for 25 periods < 5% U T (> 95% interruption of U T) for 5 s ±8 kv contact discharge ±15 kv air discharge ±2 kv for mains lines ±1 kv for input and output powers ±1 kv voltage outer conductor outer conductor ±2 kv voltage outer conductor earth < 5% U T (> 95% interruption of U T) for ½ period 40% U T (60% interruption of U T) for 5 periods 70% U T (30% interruption of U T) for 25 periods < 5% U T (> 95% interruption of U T) for 5 s Floors should be made of wood or concrete or ceramic tiles must be laid. If the floor is made or covered with synthetic material then the relative humidity must be at least 30%. The quality of the supply voltage should accord with that of a typical environment of a commercial building or hospital. The quality of the supply voltage should accord with that of a typical environment of a commercial building or hospital. The quality of the supply voltage should accord with that of a typical environment of a commercial building or hospital. 3 A/m 400 A/m Magnetic fields at the mains frequency should accord with that of a typical environment of a commercial building or hospital COMMENT: U T is the mains alternating voltage before using the test level 41