COOK Medical Hemospray Manual Del Usuario página 4

relevant clinical guidelines for management of antithrombotic agents for
endoscopic procedures.
This device is designed for single use only. Attempts to reprocess,
resterilize, and/or reuse may lead to device failure and/or transmission of
disease.
If package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an
abnormality is detected that would prohibit proper working conditions, do
not use. Please notify Cook for return authorization.
PRECAUTIONS
For best results, Hemospray must be delivered to the source of bleeding.
Ensure gastrointestinal lumen is not distended because Hemospray
adds volume in excess of insufflation volumes during procedure. Closely
monitor bowel distension and balance insufflation and Hemospray
volumes as necessary.
Use of more than (3) Hemospray devices per patient may result in
impaction in colon and is not recommended.
Product contains 16 g CO2 cartridge. Contents under pressure. Do not
puncture or heat above 120° F/ 49° C. Do not inhale or discharge towards
face/body. Keep CO2 dispenser and cartridge out of reach of children.
Hemospray is inert and non-toxic.
As a granular material, unintentional exposure to the powder may cause
potential irritation to the skin, eyes and lungs.
In the event of unintended exposure to the powder refer to the following
First Aid measures:
Skin: Wash with soap and water until clean.
Eyes: Flush with water until irritation ceases.
Inhalation: Move to area free from powder. If symptoms of irritation
persist, contact physician. Inhalation may aggravate existing respiratory
illness.
Refer to package label for minimum channel size required for this device.
All endoscopic hemostatic therapies, including Hemospray, have an
associated risk of rebleeding, particularly in situations where the cause
of bleeding is an unresolved underlying disease. After hemostasis has
been achieved, monitor patients for rebleeding per the relevant Clinical
Guidelines.
Although not seen in clinical practice, there remains a theoretical risk of
aspiration of Hemospray powder resulting in respiratory complications. It is
prudent to restrict the use of Hemospray to 5 cm below the UES.
PROCEDURAL PRECAUTIONS
Like other modalities, Hemospray may not be effective for all types of
bleeds. Gastrointestinal bleeding may exacerbate existing comorbidities,
increasing the potential for adverse events including patient mortality.
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