syramed μSP6000 PCA - EPCA Instructions for Use Edition 26-01-VA-GA-6000-PCA-E

-> Initial charge bolus. The administration is started with an initial charge bolus. After the initial charge bolus, further patient bolus can be requested by pressing the patient bolus key with respect to the lockout time.

initial charge bolus

bolus delivered

-> Physician bolus. A physician bolus can be requested at any time using the access password.

bolus delivered

surgeon bolus

PCA Configurations Nine configurations can be selected after start up: -> Individual configuration: the individual program allows to freely program the current administration and can be adapted at a later stage of the application. The initial values are always set to zero after start up. -> PCA 1 ... 8: Up to eight configurations can be freely set up and stored for later administration. After the selection of a stored configuration, the parameters can be adjusted for the current administration if needed. The values are reset to the stored configuration after the next start up. The eight stored configurations can be labeled with an alphanumeric text (12 characters) through the IR interface.

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Configuration of the pump Each configuration contains the following parameters: -> Unit:

ml, mg/ml or µg/ml

-> Concentration:

1 (unit = ml), 0.1 mg/ml - 100.0 mg/ml, 1 - 1000 µg/ml

-> Charge bolus dose:

0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg

-> Charge bolus time:

Flash or 1 - 100 min

-> Patient bolus dose:

0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg

-> Patient bolus time:

Flash or 1 - 100 min

-> Lockout time:

1 min - 24:00 h

-> Physician bolus dose: 0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg -> Physician bolus time: Flash or 1 - 100 min -> Continuous basal rate:0.1 ml/h - 500 ml/h, 0.1 mg/h - 999.9 mg/h, 1 µg/h - 9999 µg/h -> Continuous basal time: 1 min - 24:00 h -> Maximum time:

1 min - 72:00 h

-> Maximum dose:

0.1 ml - 999.9 ml, 0.1 mg - 999.9 mg, 1 µg - 9999 µg

Remarks: -

Setting the bolus time to flash will infuse the bolus at the maximum bolus rate (1500ml/h).

-

The range of the rate of the syramed µSP6000 is 0.1 ml/h to 500.0 ml/h (optional 750 ml/h) and the maximum bolus rate is 1500 ml/h. The resolution of the rate is 0.1 ml/h. The range of the volume is 0.1 ml to 999.9 ml and the resolution of the volume is 0.1 ml. Depending on the unit and concentration setting, the maximum rate and dose are limited accordingly. The final infusion rate/dose might be rounded if the corresponding volume is a fraction of 0.1 ml.

-

Disable the resetting of the volume and time after infusion complete (Service Mode Address 3 and 4), if the pump should not be allowed to continue the infusion after reaching the maximum time or dose.

-

The password can be configured (4 digits) freely in the service mode (Address 42). If the password has been set to zero, the values can only be accessed with the supervisor key. The supervisor key is inserted at the rear side of the pump in the PCA connector.

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History log and traceability: The syramed SP6000 PCA/EPCA stores an extensive history log to trace all events during an administration. Up to 1500 history logs can be stored in the pump. The history can be viewed, stored and printed by downloading the history over the IR interface during or after the application. The history can also be viewed graphically to allow a rapid and complete overview of the administration.

Syramed µSP6000 History File Date: 01/03/26, Time: 17:42:44 Pump Serial Number: 0023904 Patient Information: Patient : 3245 Long term hospitalization 15:53h 15:53h

Stop Infusion at Infused 11.2 ml. Stop patient Bolus at Infused 11.1 ml.

15:52h 15:42h 15:41h 15:36h

Start patient Bolus at Infused 8.1 ml. Unsuccessfull patient bolus at Infused 8.1 ml. Halt continuous basal rate at Infused 8.1 ml. Stop physician Bolus at Infused 7.3 ml.

15:32h 15:31h 15:31h

Stop charge Bolus at Infused 2.0 ml. Start charge Bolus at Infused 0.0 ml. Current PCA setup: Selected PCA Program: 3 Concentration Unit: ug Concentration: 10 ug Charge Bolus Dose: 20 ug; Charge Bolus Time: 1 min Patient Bolus Dose: 30 ug; Patient Bolus Time: 1 min Continuous basal Rate: 100 ug/h Continues Total: 2000 ug Lockout Time: 0:15 h Continuous basal Time: 0:05 h

The LED and LCD display on the pump show the current values and a summary of the history (current rate and volume infused, successful and unsuccessful demands, total time and dose, page 4/8

Setting up the pump - The LCD display guides through the whole set up with help comments. - After the pump has been switched on with the ON/OFF key, the syramed automatically enters the set up mode and asks for the password. - The pump can be configured to be used with a 4 digit password or with a supervisor key only. - The selections and values are entered in the Volume ML window. - To confirm a selection or value press the START/STOP key. Automatically the next step is displayed. - To go back to a previous setting, lower the program step in the Rate ML/H window with the down key. - All the configuration parameters have to be viewed and confirmed. After confirming the last parameter (Pr. 14: surgeon bolus time) with the START/STOP key, the syramed switches to the running mode. If the set up mode has been interrupted (e.g. by a syringe loading action), the pump will automatically re-enter the set up mode when starting the pump. For safety reasons, the administration can only be started after all the settings have been entered and confirmed. - The loading of the syringe is done similar to the standard syringe loading procedure of the syramed (refer to the syramed 6000 instructions for use).

How to start up the pump - Programmed modes PCA 1 - 8 1) 2) 3) 4) 5) 6) 7) 8)

Switch on the pump with the ON/OFF key. Enter the password and press the START/STOP key or plug in the supervisor key. Select the desired program with the up/down keys in the Total ML window. Press the START/STOP key. Confirm all the values (Pr. 2 - 14) with the START/STOP key until the pump switches to the running mode. Load the syringe and start the pump with the START/STOP key. The LCD display is showing the current status of the pump (running). The green syringe pictogram below the ON/OFF key is flashing when the pump is running. Make sure the door is mechanically locked.

How to start up the pump - Individual (titration) mode 1) 2) 3) 4) 5)

Switch on the pump with the ON/OFF key. Enter the password and press the START/STOP key Press the START/STOP key (confirm Individual mode). Set all the values (Pr. 2 - 14) with the keys in the Total ML window and confirm with the START/STOP key until the pump switches to the running mode. To disable undesired options leave the setting values at zero, eg: - no charge bolus -> leave the charge bolus dose at zero - no continuous basal rate -> leave continuous basal rate at zero - no limitation of continuous basal rate -> leave continuous basal time at zero - no total volume limitation -> leave total dose at zero page 5/8

How to stop the pump The pump can be stopped at any time by pressing the START/STOP key. If the pump is infusing a bolus (charge-, patient- or physician) the bolus is abandoned immediately. The administration can be continued by pressing the START/STOP key. Important: An interrupted bolus is not continued after restarting the pump (safety).

How to give an initial charging bolus dose: After start up of the pump, make sure the charge bolus dose and the charge bolus time have been set correctly. The initial charge dose is automatically administrated after starting the pump. Important: The initial charge dose is only given once at the very first start. If the pump had been stopped with the START/STOP key, no further initial charge dose is given after restarting the administration.

How to give a patient bolus: The patient bolus can be requested by pressing the patient bolus key. As an alternative the patient bolus can also be started by pressing the Option key and the BOLUS key simultaneously on the front panel of the pump. Each patient bolus is counted and accumulated. After each bolus (charge-, patient- or physician) the lockout time is activated. During the lockout time, the patient bolus demands are rejected and counted as unsuccessful patient bolus demands.

bolus delivered

accepted bolus demands

lockout time

physician bolus

refused bolus demands

The PCA history window (LCD display) gives information on the timing. The time elapsed since the last bolus had been given is displayed as well as the remaining lockout time until the next patient bolus will be accepted. Furthermore the amount of successful and unsuccessful patient bolus demands are displayed in the PCA history window.

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How to give a physician bolus: The physician bolus can be requested by holding the BOLUS key on the front panel of the pump. The LCD display will ask for the password which has to be entered in the Volume ML window. Press the START/STOP key to confirm the physician bolus. The physician bolus can also be given using the supervisor key when asked for the password.

How to change the configuration 1) 2) 3) 4) 5) 6)

Stop the pump with the START/STOP key. Double click the BOLUS key. Enter the password and press the START/STOP key or plug in the supervisor key. Press the START/STOP key and change the desired values Press the START/STOP key until the pump switches to the running mode. Press the START/STOP key to start the pump.

How to program and store the configuration PCA 1 - 8 1) 2) 3) 4) 5) 6) 7)

Switch on the pump with the ON/OFF key. Enter the password and press the START/STOP key or plug in the supervisor key. Select the desired program with the up/down keys in the Total ML window. Press the START/STOP key. Set all the values (Pr. 2 - 14) with the keys in the Total ML window and confirm with the START/STOP key until the pump switches to the running mode. Hold the OPTION key when switching off the pump with the ON/OFF key (save). Repeat this procedure for each configuration

How to continue a PCA administration (memory key) If the syramed has been swiched off, the PCA administration can be continued by recalling all the values at start up: 1) 2) 3) 4)

Hold the START/STOP key (5 sec) while switching on the pump with the ON/OFF key. The pump will go through the display test. Enter the password and press the START/STOP key or plug in the supervisor key. Confirm all the values (Pr. 2 - 14) with the START/STOP key until the pump switches to the running mode. Press the START/STOP key to continue the administration.

How to start a new PCA administration To start a new PCA administation, switch off the pump. After switching on the pump, all the values will be reset to zero.

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Specifications: Continuous rate:

0.1 ml/h - 500 ml/h (759 ml/h), 0.1 mg/h - 999.9 mg/h, 1 µg/h - 9999 µg/h

Maximum bolus rate:

1500 ml/h

Maximum dose:

0.1 ml - 999.9 ml, 0.1 mg - 999.9 mg, 1 µg - 9999 µg

Unit: Concentration:

ml, mg/ml or µg/ml 1 (unit = ml), 0.1 mg/ml - 100.0 mg/ml, 1 - 1000 µg/ml

Charge bolus dose: Charge bolus time:

0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg Flash or 1 - 100 min

Patient bolus dose: Patient bolus time: Lockout time:

0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg Flash or 1 - 100 min 1 min - 24:00 h

Physician bolus dose: Physician bolus time:

0.1 ml - 100.0 ml, 0.1 - 100.0 mg, 1 - 1000 µg Flash or 1 - 100 min

Continuous basal time:

1 min - 24:00 h

Maximum time:

1 min - 72:00 h

PCA Modes

Bolus only, Bolus and continuous basal rate, Bolus and limited continuous basal rate

Configurations

1 Individual (titration) and 8 programmed

Configuration labeling

12 characters for each programmed configuration. Programming through the IR Interface.

History log

up to 1500 events, all events and current configuration with real time clock. Read out of the history through the IR interface.

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