This chapter provides information about the annual inspection, and information and instructions for performing the safety tests.
Annual Inspection
The Manufacturer stipulates that these tests are performed annually to assess its functionality and technical safety. These inspections must be
carried out annually. Regular inspections will assist in early detection of possible malfunctions. This helps maintain the system and increases its
safety and service life.
WARNING!
If the specified parameters and tolerances are exceeded, the system must be returned to Hologic for evaluation.
Load Cell Calibration Check
The fluid deficit measurement test checks the fluid bag load cell and the waste bag load cell and the accurate measurement of weight pressure
(and differential) to ensure that all elements are functioning properly. This test requires a 500 gram weight.
1.
Turn the system ON.
2.
Touch ( ) button for settings screen.
3.
Press the 'Load Cell Calibration Check' button.
4.
Press the 'Zero Load Cells' button. Follow the on-screen prompts to zero the load cells (i.e., scales).
5.
Once the load cells have been zeroed, the 'Supply Weight' and 'Collection Weight' should read 0±25g. If either weight is not within the
acceptable range, contact Technical Support.
6.
Hang the 500 gram weight on one of the fluid bag hooks. The 'Supply Weight' should read 500±25g. If the reading is not within the acceptable
range, contact Technical Support.
7.
Remove the 500 gram weight from the fluid bag hooks and hang it on one of the waste bag hooks. The 'Collection Weight' should read
500±25g. If the reading is not within the acceptable range, contact Technical Support.
8.
Remove the weight from the waste bag hook.
9.
Select 'Exit' to return to the settings screen, then select 'Exit' to return to the setup screen.
Pressure Calibration Check
The pressure measuring test checks the pressure chamber, pressure sensor and the accurate measurement of pressure to ensure that all
elements are functioning properly. This test requires an in-FloPak and 3000mL fluid bag and an under buttocks drape or bucket. The fluid bag is
placed on the supply load cell hanger to produce the hydrostatic pressure that is used to test the pressure sensor.
1.
Turn the system ON.
2.
Place the in-FloPak onto the console.
3.
Touch ( ) button for settings screen.
4.
Choose 'Pressure calibration check'.
5.
Choose 'Lock'.
6.
Hang the 3000mL of fluid bag on one fluid bag hook. Make sure that bag clamp is pinched. (Fluid will spill out if not done).
7.
Fully pinch both inflow clamps.
8.
Remove bag spike cap and spike bag with one inflow spike, leave other spike capped.
9.
Place a bucket onto the ground and place the Hysteroscope Inflow Channel Luer lock into the bucket.
10.
Open clamp connected to full bag.
11.
Open clamp connected to the in-FloPak.
12.
Open clamp connected to the Hysteroscope Inflow Channel Luer Lock.
13.
Touch 'Start' to fill tube with fluid. When tube is filled and air bubbles in line are gone, touch 'Stop'.
14.
Remove the Luer Lock from the bucket and hold it even with the tip of the fluid bag bracket.
15.
Apply firm, even pressure on the In-FloPak to ensure it is seated properly.
16.
Number displayed for pressure reading should be 20±5 inH20.
17.
Place the Luer Lock back into the bucket.
18.
Select 'Exit' to return to the settings screen, then select 'Exit' to return to the setup screen.
19.
Pinch fluid bag clamp.
20.
Remove bag spike from the fluid bag. Then remove cartridge from the console to allow fluid to drain into the bucket.
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Fluent Fluid Management System
Chapter 11: Annual Inspection and Testing
Chapter 11: Annual Inspection and Testing
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