CapsoVision CVR1 Instrucciones De Uso página 2

1. Retrieval Pan
2
Directions for Use – Patients
For patients who need help with the retrieval process, please ask your caregiver for assistance.
Read these instructions in their entirety before you use the kit. The kit contains a retrieval pan, a magnetic wand, a cup and a storage vial.
2. Magnetic Wand to
pick up the capsule
Place the kit in the bathroom you plan to use until the capsule is excreted.
*Do not remove the desiccant pouch from the retrieval vial
Step 1:
Place the pan on the back half of the toilet rim,
as shown, and lower the toilet seat. It may be
temporarily removed for non-patients.
Step 2:
Defecate into the pan until the capsule is excreted.
Throw toilet paper directly into the toilet bowl.
Step 3:
Rinse the pan with water to find the capsule.
Once the capsule is found, rinse it.
Do not yet flush the toilet if you suspect
the capsule may have accidentally been
excreted outside the pan into the toilet
bowl! See Step 4.
Step 4:
Grasp the wand by the blue handle and pick up the
capsule with the magnetic tip. If you suspect the
capsule may be in the toilet bowl but you cannot see
it, probe the drain of the bowl with the wand.
Manufacturer
CapsoVision, Inc.
18805 Cox Ave, Suite 250
Saratoga, CA 95070 USA
Tel: +1 408 624 1488
Email: customerservice@capsovision.com
3. Cup for rinsing
European Authorized Representative
MedDevConsult GmbH
Airport Center (Building C)
Flughafenstrasse 52a
22335 Hamburg, Germany
ec-rep@meddevconsult.de
IFU-1461-ENG Rev U 04/2020
4. Retrieval Vial with desiccant pouch
Step 5:
With the capsule attached to the tip of the
wand, place it into the vial. Close the vial
lid over the wand and pull the wand away,
stripping off the capsule. Lock the vial by
lowering and snapping the lid tab.
Step 6:
Place pan and wand into the plastic bag.
Dispose of the kit in the trash or recycling
in accordance with local laws.
Step 7:
Follow your physician's instructions
for returning the vial to the clinic or office.
OR
In the United States, the healthcare
provider may provide a prepaid FedEx
mailing envelope for the vial to be mailed
directly to a download center.
Place the vial in the envelope, seal and
place in a FedEx Drop Box or take to a
FedEx store.
Conformity Assessment Body
TÜV Rheinland LGA Products GmbH
Tillystrasse 2
90431 Nuremburg, Germany