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  9. COOK Medical Hemospray User manual

COOK Medical Hemospray User manual

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Prep 1 Prep 2
Remove device from package and attach
catheter to handle, ensuring connection
is secure.
Activate CO2cartridge by turning red activation
knob until it stops.
Step 1
Before inserting catheter into accessory
channel, identify bleeding site, remove as
much blood as possible, then flush accessory
channel with air.
Step 2
Slowly advance catheter through accessory
channel in short increments until catheter tip
is visualized endoscopically. Precaution: To
avoid catheter occlusion, do not place catheter
directly in contact with blood and/or mucosa,
including any pooled blood and do not aspirate
blood while catheter is in accessory channel. To
ensure proper visibility, catheter tip should be
1-2 cm away from bleeding site at all times.
Hemospray
®
ENDOSC
OPIC HEMOSTAT
QUICK REFERENCE GUIDE
Step 3
To allow powder deployment, turn red valve to
open position. Note: Device is now active and
ready for use. Do not press trigger button until
powder deployment is desired.
MEDICAL
Step 6
Upon completion of procedure, depressurize
device by rotating red activation knob
counterclockwise until CO2cartridge
depressurizes completely.
Step 5
Prior to removing Hemospray device from
patient, turn red valve to closed position. To
remove device from endoscope, grasp catheter
and pull slowly.
Dispose of device per institutional guidelines
for biohazardous medical waste.
Refer to current instructions for detailed system use.
Summary of Clinical Data:
Clinical data summary information that was,
in part, the basis for granting the de novo
can be found on the Cook Medical website at
CookMedical.com/HemosprayData
Step 4
To deploy powder, depress red trigger
button for 1-2 seconds and release. Continue
applying in short bursts until site is completely
covered with powder and no active bleeding
is visualized. Multiple applications may be
required; however, no more than (3) Hemospray
devices should be applied per patient.
Note: Allow time for hemostasis before
aspirating. Irrigation of treated site is not
required after powder deployment. If irrigation
is desired, allow time for hemostasis before
irrigating with water. To avoid potential
endoscope occlusion, do not aspirate powder
into endoscope channel. If catheter becomes
occluded during procedure, turn red valve
to closed position, remove catheter from
endoscope and replace with extra catheter
provided in package. Then repeat steps 1-4.
If more powder is needed and spray canister
and/or CO2cartridge is empty, a new device
is required.
MEDICAL
© COOK 05/2018 ESC-D43164-EN-F
AI, ESC, IR, OHNS, PI, RH, SUR-8.5X11