Coloplast Isiris a Bedienungsanleitung Seite 10

5. Be careful when handling the distal tip of the insertion cord and do not allow it
to strike other objects, as this may result in damage to the equipment. The lens
surface of the distal tip is fragile and visual distortion may occur.
6. The scope connector must not be twisted when inserted into the monitor plug -
this could potentially damage the scope connector or the monitor plug.
7. Do not exert excessive force on the bending section, as this may result in
damage to the equipment. Examples of inappropriate handling of the bending
section include:
– Manual manipulation and bending such as performing retrograde vision
inside bladder.
– Operating it in any case where resistance is felt.
8. Be sure to connect the irrigation line properly to the irrigation connector
before introducing fluid. Failure to do so may result in the fluid spilling from the
irrigation connector, which may harm the device.
9. Secure syringes properly on the irrigation connector before aspiration is
applied to avoid leakage.
10. This device contains the following substance defined as CMR 1B in a concentration
above 0.1 % weight by weight: Cobalt; (CAS No. 7440-48-4; EC No. 231-158-0).
Current scientific evidence supports that medical devices manufactured from
stainless steel alloys containing cobalt do not cause an increased risk of cancer or
adverse reproductive effects for all patient populations.
11. US federal law restricts this device to sale by or on the order of a licensed health
care practitioner.
NOTES
• The manufacture is not responsible for any damage to the system or patient
resulting from incorrect use.
2. System description
The Isiris α can be connected to the Isiris Monitor. For information about the Isiris
Monitor, please refer to the Isiris Monitor Instructions for use.
2.1. System parts
Isiris α
The Isiris System consists of Isiris α and Isiris Monitor. Isiris α is a sterile single use device.
Isiris Monitor is reusable.
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