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Summary of Contents for Braun SpaceControl
- Page 1 SpaceControl for automated glucose control Instructions for use Valid for software I93050A...
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Page 2: Table Of Contents
5.3.2 Options > System Data > System Data ..........19 5.3.3 Options > System Data > SpaceCom .............20 5.3.4 Options > Configuration SGC ..............20 5.3.5 Options > Configuration SpaceControl ..........21 5.4 Start / Stop and Overview ..................21 6 Start-up and self-test................... 22... - Page 3 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 Confirming 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...
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Page 4: About This Document
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... -
Page 5: Safety Instructions
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. - Page 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 ...
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Page 7: Safe Application Of The Automated Glucose Monitoring
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 ... -
Page 8: Other Components
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 ... -
Page 9: Description Of The Device
Description of the device 3 Description of the device 3.1 Displays and controls No. Name / Function 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 ... -
Page 10: Interfaces
Description of the device 3.2 Interfaces No. Symbol Interface – To insulin pump for power supply and data communication For expansions, e.g. SGC module Without function in this software version – Infrared (IrDA) 3.3 Symbols on the device Symbol Meaning Attention! Observe accompanying documents. Observe disposal instructions. Type CF defibrillator-protected part ... -
Page 11: Application Of The Automated Glucose Monitoring
As a combination at any slots in the SpaceControl SpaceStation. Only one SpaceControl 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. -
Page 12: Tasks Of The Device Within The Sgc System
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. -
Page 13: Description Of The Functions / Operation
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. -
Page 14: Overview Screen (Example)
Description of the functions / Operation 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 ... -
Page 15: Display Of Alarm States
Reminder alarms for incomplete entries at the insulin pump and at the SpaceControl can be acknowledged by pressing anywhere on the touch screen. -
Page 16: Navigation And Input Elements
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... - Page 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 / ...
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Page 18: Menu Structure / Overview Of Functions
Menu structure / Overview of functions 5 Menu structure / Overview of functions 5.1 Main menu Menu Purpose 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 ... -
Page 19: Options
Export therapy data to an external data medium. Configuration Set therapy-relevant parameters. P. 20 Configuration Set and display device-specific parameters. P. 21 SpaceControl 5 .3.1 Options > Patient Data Parameter Purpose Display patient ID. – Only active during running SGC therapy. Weight Display the patient weight. -
Page 20: Options > System Data > Spacecom
Menu structure / Overview of functions 5 .3.3 O ptions > System Data > SpaceCom Parameter Purpose 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. –... -
Page 21: Options > Configuration Spacecontrol
Menu structure / Overview of functions 5 .3.5 O ptions > Configuration SpaceControl Menu Purpose 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. -
Page 22: Start-Up And Self-Test
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;... -
Page 23: Operation
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. - Page 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.
- Page 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 ...
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Page 26: Calculation Of New Suggested Values
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. -
Page 27: Hypoglycaemia Warning
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. 7 .2.1 Hypoglycaemia warning The blood glucose value entered is less than or equal to the preset threshold. -
Page 28: Confirming The Suggested Insulin Dose Rate / Sgc Mode
Operation 7.3 C onfirming 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. To reduce the suggested time until the next blood glucose measurement: –... -
Page 29: Overruling The Insulin Dose Rate / Manual Mode
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. Press Dose Rate. -
Page 30: Returning To The Sgc Mode
Operation 7.6 Returning to the SGC mode In the overview screen, press Blood Glucose. –or– Press Main menu > Blood Glucose > Blood Glucose. Confirm the blood glucose value or enter the new value. The new suggested values are calculated (see Chapter 7.2, P. 26). Confirm the suggested insulin dose rate. The insulin dose rate is set at the insulin pump. The system changes to the SGC mode. -
Page 31: Entering Parenteral Bolus
Operation 7.9 Entering parenteral bolus Making the entry via drug and volume administered Press Nutrition > Parenteral Bolus. Using the button, select the carbohydrate drug and confirm with 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 Press Nutrition > Parenteral Bolus. -
Page 32: Enabling Standby Mode On The Device As Well As Insulin And Nutrition Pumps
Operation 7 .11 E nabling 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. Press Options > Standby. Carry out the instructions in the display. Note: To cancel standby mode, please follow the instructions in the display. -
Page 33: Displaying The Nutrition Pump Settings (Enteral / Parenteral)
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. -
Page 34: Ceasing The Therapy
Operation 7 .16 Ceasing the therapy Press Main menu > Special Functions > SGC Mode > Off. Switch off the insulin pump or enable the standby mode (see separate instructions for use). 7 .17 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. -
Page 35: Steps To Be Taken If The Sgc Therapy Does Not Start
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... - Page 36 - 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.
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Page 37: Alarms
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 Cause and corrective measure... -
Page 38: Cleaning And Care / Disposal
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. ... -
Page 39: Technical Safety Check (Tsc) / Service
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. -
Page 40: Technical Data
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 60601-1: Protection class II For Type CF defibrillator-protected parts IP 21 moisture protection (drip-proof when used ... -
Page 41: Instructions On Electromagnetic Compatibility (Emc)
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 Electromagnetic environment – Guidelines HF emissions according to CISPR 11 Group 1... - Page 42 Instructions on electromagnetic compatibility (EMC) Immunity tests IEC 60601 test level Compliance level Electromagnetic environment – Guidelines Derived HF disturbance Portable and mobile radios should not be used at a closer eff. value variables according to 150 kHz … 80 MHz distance to the device, including the lines, than the recom- IEC 61000-4-6 mended protective clearance distance calculated using the equation appropriate to the transmission frequency.
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Page 43: Order Data
Order data 14 Order data Designation Article No. SpaceControl (incl. software) 871 3090 Recommended additional equipment: Designation Article No. SpaceStation 871 3140 SpaceCom 871 3160 SpaceStation with integrated SpaceCom 871 3142 SpaceCover Standard 871 3147 SpaceCover Comfort 871 3145 Perfusor®Space 871 3030 Infusomat®Space 871 3050 Infusomat®Space P 871 3070 SGC module (incl. - Page 44 Manufactured by B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany Tel.: +49 (0) 56 61 71-0 | www.bbraun.com | www.space.bbraun.com 7700117 • 1210 | Date of last Revision: December 2010...
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