COOK Medical Hemospray Endoscopic Hemostat, Инструкция по эксплуатации

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Hemospray may occlude ducts and orifices which communicate with the main bowel lumen. Use
caution when using Hemospray in the vicinity of these orifices.
Others include, but are not limited to: powder impaction in colon or embolization.
When spraying in retroflexed position, Hemospray powder may adhere to the outside of the
endoscope. This may result in difficulty repositioning/removing the endoscope, particularly if
passing through a strictured area.
MRI SAFETY INFORMATION
While Adverse Effects related to MR safety have not been observed in clinical use, Hemospray has
not been evaluated for safety and compatibility in the MR environment. It has not been tested for
heating, migration, or image artifact in the MR environment. The safety of Hemospray in the MR
environment is unknown. Scanning a patient who has this device may result in patient injury.
SYSTEM PREPARATION
1. Remove device from package.
NOTES
Do not over rotate knob as this could damage the device (See Fig. 1) .
Do not test device prior to insertion into endoscope accessory channel as this may increase risk
of catheter occlusion.
2. Activate CO2 cartridge by turning red activation knob until it stops.
INSTRUCTIONS FOR USE
CAUTION
Ensure gastrointestinal lumen is not distended because Hemospray adds volume during
procedure.
1. Before inserting catheter into accessory channel, identify bleeding site, remove as much
blood as possible, then flush accessory channel with air.
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.
NOTE
To limit fluid from entering the working channel of the catheter, temporarily occlude the proximal
end of the catheter by placing a thumb over the red catheter hub, while advancing the catheter
down the accessory channel
(See Fig. 2) .
2. Slowly advance catheter through accessory channel in short increments until catheter tip is
visualized endoscopically (See Fig. 3) .
3. To ensure proper visibility, catheter tip should be 1-2 cm away from bleeding site at all
times (See Fig. 4) .
4. Attach the catheter to the handle, ensuring the connection is secure (See Fig. 5) .
NOTE
Device is now active and ready for use. Do not press trigger button until powder deployment
is desired.
5. To allow powder deployment, turn red valve to open position such that the valve is parallel
with the direction of spray (See Fig. 6) .
PRECAUTION
The first press of the trigger may not deploy an adequate amount of powder to achieve
hemostasis; press again to continue the movement of powder through the system.
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