Savina, test instructions flow measurement

Note: Please follow these instructions step by step. Document all tested values on the
feedback form located at the end of this document.

1 Information

1.1 Test equipment for test set-ups used during these instructions

• Adult tubing system according to Savina Instructions for Use / Operating Instructions

and

• Dräger adult test lung P/N 8403201 including catheter connector ISO no. 7 (the use of this
test lung is recommended)

or

• Siemens test lung (if no Dräger test lung is available)

2 Documentation of device data

Enter the following information into the feedback form:

• Savina S/N
• Installed SW version
• Total operating hours
• Avarage setting for O2 concentration used (if possible please ask user)

2.1 Test in the ventilation mode IPPV (US = CMV)

Note: The VT set value of 500mL is compared with the measured value Vte. The measured value
VTe is displayed is the menu “Values“.

• Assemble Savina ready for operation

• Test set-up: Connect adult tubing system according to Instructions for Use / Operating
Instructions.
• Connect test lung to Y piece
• Connect Savina to mains
• Switch on Savina
• Settings:
Ventilation mode = IPPV (US = CMV)
VT = 500 mL
Tinsp = 2s
f = 10 bpm
O2 = 21 Vol. %

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 PEEP = 4 mbar

In menu “Settings“:
Trigger = OFF
FlowACC = 50 mbar/s
AutoFlow = OFF

In menu “Alarms“:
Paw = max
MVmin = min
MVmax = max

In menu “Configuration 2/4“:

Flow monitoring = ON
Pmax = OFF
Plateau = ON

• Calibrate expiratory flow measurement by moving flow sensor to the left and back to the right.
Note: Alarm “Flow sensor? !!!“ must be displayed when flow sensor is detected in the left
position.
• Wait 1 minute
• Read out displayed value VTe in menu “Values“.
Test value VTe = 480 +/- 75 mL
• Document displayed value VTe in feedback form.
• Use a different exp. flow sensor.
• Calibrate expiratory flow measurement by moving flow sensor to the left and back to the right.
Note: Alarm “Flow sensor? !!!“ must be displayed when flow sensor is detected in the left
position.
• Wait 1 minute
• Read out displayed value VTe in menu “Values“.
Test value VTe = 480 +/- 75 mL
• Document displayed values VTe in feedback form.
• If both displayed values VTe are out of tolerance replace TSI flow sensor P/N 8413579 in step
3.
• End of instructions if both displayed values VTe are within tolerance. Return feedback form.

3 Install new TSI flow sensor and test of flow measurements

3.1 Install new TSI flow sensor

Electrostatic discharge may damage electrostatic sensitive devices. Use an

antistatic mat and a wrist strap when handling electrostatic sensitive devices.!

Note: For further information please refer to the Savina Repair Instructions on DORIS.

• Remove blue fuse in power pack on the back side

• Remove all filters from Savina
• Open Savina back plate
• Enter S/N of new TSI flow sensor on feedback form

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• Renew TSI flow sensor
• Enter S/N of removed TSI sensor on feedback form
• Close back plate and install all filters.
• Connect blue fuse in power pack

Note: The following test is identical to test 2.1.

3.2 Test in the ventilation mode IPPV (US = CMV)

Note: The VT set value of 500mL is compared with the measured value Vte. The measured value
VTe is displayed is the menu “Values“.

• Assemble Savina ready for operation

• Test set-up: Connect adult tubing system according to Instructions for Use / Operating
Instructions.
• Connect test lung to Y piece
• Connect Savina to mains
• Switch on Savina
• Settings:
Ventilation mode = IPPV (US = CMV)
VT = 500 mL
Tinsp = 2s
f = 10 bpm
O2 = 21 Vol. %
PEEP = 4 mbar

In menu “Settings“:
Trigger = OFF
FlowACC = 50 mbar/s
AutoFlow = OFF

In menu “Alarms“:
Paw = max
MVmin = min
MVmax = max

In menu “Configuration 2/4“:

Flow monitoring = ON
Pmax = OFF
Plateau = ON

• Calibrate expiratory flow measurement by moving flow sensor to the left and back to the right.
Note: Alarm “Flow sensor? !!!“ must be displayed when flow sensor is detected in the left
position.
• Wait 1 minute
• Read out displayed value VTe in menu “Values“.
Test value VTe = 480 +/- 75 mL
• Document displayed value VTe in feedback form.
• Use a different exp. flow sensor.

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• Calibrate expiratory flow measurement by moving flow sensor to the left and back to the right.
Note: Alarm “Flow sensor? !!!“ must be displayed when flow sensor is detected in the left
position.
• Wait 1 minute
• Read out displayed value VTe in menu “Values“.
Test value VTe = 480 +/- 75 mL
• Document displayed values VTe in feedback form.

4 Final Test

Check Savina according to Savina PMS (Test Certificate) including electrical safety test.

5 Return removed TSI flow sensor

Please return all removed parts to the address shown on the delivey note. Return feedback form.

Note: Use the original packeging with end caps for returning the TSI flow sensor.

End of instructions

Savina Test instructions flow measurement April 23, 2002 4/5

To:

Draeger Medical AG & Co. KGaA

Andreas Lenke
Cost Center 2170
Moislinger Allee 53-55
D-23542 Lübeck

FAX: + 49 – 451 – 882 - 4179

Feedback form Savina

Enter Savina S/N: A R __ __ - __ __ __ __ Installed SW version: ____________

Savina Operating hours: ________________ hours Avarage O2 conc. used: _____ Vol. %

2 Test of insp. and exp. flow measurement

2.1 Test in the ventilation mode IPPV with set VT = 500 mL

VTe = ___________ mL (first Spirolog sensor)

VTe = ___________ mL (second Spirolog sensor)

Alarm “Flow mesurement inop“ occured?: Yes: q No: q

3 Replacing TSI flow sensor and tests

3.1 S/Nos of installed and replaced TSI flow sensors

S/N of new TSI sensor: ______________________________

S/N of replaced TSI sensor: ______________________________

3.2 Test in the ventilation mode IPPV with set VT = 500 mL

VTe = ___________ mL (first Spirolog sensor)

VTe = ___________ mL (second Spirolog sensor)

4 Savina passed all tests described in the PMS (Test Certificate): Yes:q No: q

Additional pages for commets attached: Yes:q No: q

Your Name (please print): Subsiduary: Date: Signature:

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