COOK Medical Hemospray Endoscopic Hemostat, Инструкция по эксплуатации

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WARNING
Keep catheter tip at least 1 cm away from bleeding site to minimize risk of embolization.
Hemospray has not been approved for use in pediatric populations, no safety or effectiveness
data exists and would be considered off-label usage, to do so is at the professional risk of the
surgeon/healthcare professional.
Patients with gastrointestinal bleeding that are on antithrombotic medication may be at
an increased risk of rebleeding. Follow the 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.
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.
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