B. Braun Space GlucoseControl (SGC) Quick Reference Guide Valid for software I9305_C Automated Infusion Systems
Starting a new insulin therapy SpaceControl cannot be switched on and off by itself. It is switched on and off via the insulin pump. To start, switch on the insulin pump, select insulin from the drug library and wait for the connection with the SpaceControl to be established. 1. Press On to confirm the SGC mode 2. Enter the patient s actual weight and confirm with OK 3. Press ID, to introduce the patients ID and confirm with OK 4. Press Yes to SGC Mode: Confirm data? Check that the SGC profile is displayed on the insulin pump and that the blue LED light is on both the SpaceControl and insulin pump.
Starting a new insulin therapy 1. Enter the blood glucose value and confirm with OK, the insulin rate and sampling time will now be calculated Entering an incorrect blood glucose value has a long term effect on the SGC algorithm even if the correct value is subsequently entered. If necessary, correct an incorrect value with correct last value, pressing Main menu > Blood Glucose > Correct last value 2. Confirm the suggested insulin rate and sampling time, the insulin rate will now be transferred to the insulin pump 3. Press Start on the screen or press on the insulin pump to commence therapy The overview screen is now displayed: 4. The insulin therapy has been started. The actual status is shown on the overview screen Any nutritional products running are also displayed on the overview screen and the SGC profile is displayed on the corresponding pump. Starting a new insulin therapy
Next glucose level/ changing insulin syringe 1 2 3 4 Overview Screen 5 6 7 1. Name of the insulin drug used 2. Time until next blood glucose measurement 3. Last measured blood glucose value (press to edit) 4 Time curve of previous blood glucose values and insulin dose rates; 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 soft limit symbol as in the display of the insulin pump
Introducing next glucose level After the calculated sampling time has ran out the new blood glucose concentration has to be introduced. The system will give a yellow prealarm (see alarms). 1. Confirm the alarm by pressing on the insulin pump or by pressing on the overview screen 2. Press Blood Glucose on the overview screen or Main menu > Blood Glucose > Blood Glucose 3. Enter the new measured blood glucose value confirm blood glucose value with OK 4. Confirm the suggested insulin dose rate and sampling time Changing the insulin syringe Clamp the infusion line to the patient to avoid dosage errors during syringe change. Never leave the pump unattended during a syringe change. 1. Press on the insulin pump to stop the infusion 2. Main menu is displayed 3. Open the syringe holder to replace insulin syringe and follow the instructions on the display 4. Recommence therapy by pressing on the insulin pump Therapy will continue with the same insulin rate. Next glucose level/ changing insulin syringe
Manual mode/reducing sampling time/continuing/interrupting insulin therapy Overruling the insulin rate (manual mode) If you don t want to confirm the suggested insulin rate: 1. Press Dose rate 2. Change to the desired value and confirm with OK to 3. Confirm your new chosen insulin delivery rate If the entered value lies outside the defined hard or soft limits, a corresponding message is displayed. Only the soft limit can be confirmed. The sampling interval will automatically be set at the minimum of 30 minutes. The manual mode is displayed in the overview screen by the following symbol: You can go back in SGC mode anytime by introducing a new blood glucose level and confirming the suggested insulin rate and sampling time. Reducing the sampling interval If you want to return to SGC mode without entering a new blood glucose value, please select: Main menu > Blood Glucose > Recalculate insulin dose rate in the blood glucose menu. If the patient s clinical situation significatly changes this may require to reduce the current proposed blood sampling time. 1. Press Main menu > Blood Glucose to access the Blood Glucose screen 2. Press Measure in 3. Press -30 min to reduce the sampling time to the desired value and confirm with OK (see the corresponding screen on the left)
Interrupting the insulin therapy To place the insulin therapy into Standby Mode follow these instructions on the Insulin Pump 1. Press on the insulin pump 2. Press the once to access the insulin pump standby function 3. Answer Yes with the arrow key to Use standby? Nutrition pumps should be also in Standby Mode or turned off. To End the insulin therapy follow these instructions on the Insulin Pump: 1. Press on the insulin pump and remove the insulin syringe Continuing the insulin therapy after interruption After an interruption the therapy can be continued if the following two requirements are met: The SGC therapy data, as well as the body weight, are identical. The duration of the interruption was less than one hour. 1. If the system is in Standby Mode please follow the instruction on the SpaceControl screen to continue the insulin therapy 2. If the insulin syringe has been removed and the insulin pump has been turned off, to continue the same insulin therapy, start insulin therapy in the usual way and carry out the instructions given on the SpaceControl display. This option to continue the therapy is only available for 60 minutes after pump is turned off. Manual mode/reducing sampling time/continuing/interrupting insulin therapy
Nutrition Changing the nutrition rate 1. Change the rate at the respective nutrition pump (enteral or parenteral) The new suggested values are calculated by the SGC 2. Confirm the suggested insulin dose rate. The new insulin rate will now be transferred to the insulin pump Stopping nutrition or interrupting for short period 1. Stop the respective nutrition pump (enteral/parenteral) manually 2. Observe instructions on the SpaceControl display 3. Choose suspend nutrition temporarily only if intend to interrupt the nutrition for less than 5 minutes, for anything greater choose stop nutrition If no entry or action has been carried out within five minutes (e.g. for the disposable replacement), the new suggested values will be recalculated. 4. If a new insulin rate is calculated Confirm the new rate Note: If the new insulin rate is not confirmed within 5 minutes, the insulin infusion will be stopped and the red alarm will go off.
Entering a parenteral bolus Via drug and volume administered: 1. Press nutrition > parenteral bolus 2. Select the carbohydrate drug using or and confirm with OK 3. Enter volume administered and confirm with OK The new suggested values will now be calculated Via amount of carbohydrate: 1. Press nutrition > parenteral bolus 2. Using or select drug Others 3. Enter amount of carbohydrate and confirm with OK The new suggested values will now be calculated Entering a meal 1. Press nutrition > meal 2. Enter the estimated amount of carbohydrate and confirm with OK The new suggested values will now be calculated Nutrition
Alarms An alarm can be confirmed on the SpaceControl screen with the button or directly at the insulin pump. Please observe the alarm reasons on the information window before confirming the alarm. The following alarms may occur during a therapy: Alarm Icon Cause and corrective measure Alarms/ Oberservations Operating alarm, SGC end The SGC therapy currently running cannot be continued Continue the therapy (see continuing the insunlin therapy) Prealarm, blood glucose measurement Reminder alarm, hypoglycemia The time for the next blood glucose measurement has been exceeded Confirm the alarm Measure and enter the blood glucose value (see introducing next glucose level ) A parametral bolus has not been entered within 10 minutes after an hypoglycemia alarm Confirm the alarm In case of glucose injection to treat hypoglycemia: enter the parametral bolus
Oberservations 1. The active/interaction fields on SpaceControl unit are yellow 2. The blood glucose measurement device must be validated for use in intensive care 3. If the insulin 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, Main menu > Bloodglucose > Measure in > -30 min > OK 4. If the patient s clinical situation significatly changes this may require to reduce the current proposed blood sampling time, Main menu > Blood glucose > Measure in > -30 min > OK 5. Changes of the insulin dose may influence the potassium level of the patient. Please regularly check the blood potassium level. If the insulin dose rate exceeds 10 IU/h a message to check the potassium concentration is displayed on the SpaceControl screen when insulin pump stops 6. SGC automatically collects the information from insulin and nutrition pumps and calculates the insulin rate and sampling time but is the user responsibility to confirm the suggested insulin rate and start/stop insulin pump 7. It is recommended to use insulin infusion lines of adequate material in order to avoid saturation effects of the infusion line material. Alarms/ Oberservations
! Attention: The Quick Reference Guide gives you a short overview of the main operation functions but does not replace the Instructions for Use of Space GlucoseControl and does not release the user to read the IFU in detail. Space Station Enteral Nutrition Parenteral Nutrition Insulin Pump SGC Module SpaceControl Pen for Touch Screen B. Braun Melsungen AG Hospital Care 34209 Melsungen Germany Tel. +49 5661 71-0 www.space.bbraun.com www.bbraun.com