COOK Medical Hemospray Series Manual - Page 5

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POTENTIAL COMPLICATIONS

Those associated with gastrointestinal endoscopy include, but are not

limited to: perforation, hemorrhage, aspiration, fever, infection, allergic

reaction to medication, hypotension, respiratory depression or arrest,

cardiac arrhythmia or arrest.

Use of Hemospray in the presence of bowel obstruction and/or an

anastomosis may pose a risk of injury due to over-distention.

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.

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.

1. Remove device from package and attach catheter to handle, ensuring

connection is secure (See Fig 1).

2. Activate CO2 cartridge by turning red activation knob until it stops.

Note: Do not over rotate knob as this could damage the device (See

Fig. 2). Note: Do not test device prior to insertion into endoscope

accessory channel as this may increase risk of catheter occlusion.

INSTRUCTIONS FOR USE

1. Before inserting catheter into accessory channel, identify bleeding site,

remove as much blood as possible, then flush accessory channel with

air. Caution: Ensure gastrointestinal lumen is not distended because

Hemospray adds volume during procedure.

2. Slowly advance catheter through accessory channel in short

increments until catheter tip is visualized endoscopically (See Fig. 3).

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.

3. To ensure proper visibility, catheter tip should be 1-2 cm away from

bleeding site at all times (See Fig. 4).

4. To allow powder deployment, turn red valve to open position (See Fig.

5). Note: Device is now active and ready for use. Do not press trigger

button until powder deployment is desired.

5. To deploy powder, hold handle upright and depress red trigger

button for 1-2 seconds and release (See Fig. 6). Continue applying