G&N SIGMOLUX 701000 Instructions For Use Manual

SIGMOIDOSCOPE
WITH LIGHT GUIDE, LENS AND INSUFFLATOR
Product Description
Description
SIGMOLUX®
SIGMOLUX™ is a single use, fully disposable and self-illuminating rigid Sigmoidoscope.
These devices are used during either rectal examination or rectal surgery, for use in
examination, diagnosis and treatment of the large intestine. SIGMOLUX™ is supplied with
an attached insufflator, a pre-loaded introducer and a hinged lens. The insufflator
incorporates a hand squeeze pump with a one-way
valve and reservoir (bladder) and is intended to inflate the colon during procedures according
to standard clinical practice All SIGMOLUX™ devices are shipped ready for use.
Should the light output become obscured due to debris, the end of the light guide can be
cleared by re-inserting the introducer.
Re-use of this device represents an unnecessary and avoidable risk of cross infection to the
patient.
Application
The G+N Medical SIGMOLUX™ and associated Illuminator are intended to provide a means
of endoscopic access to the patient's large intestine and to supply effective illumination,
thus permitting direct visual examination by a suitably qualified and experienced
Healthcare Professional.
The devices key functions are:
To enable trained Healthcare Professionals, to effectively view patients' large intestine to
1.
perform invasive investigational procedures.
Reduce the complexity and increase the ease of use by having a light source directly attached
2.
to the device, enabling the large intestine to be viewed by the operator. The internal light
source illuminates the area without the need for extra equipment.
Intended Use
The G+N Medical SIGMOLUX™ is intended to provide a means of rigid endoscopic access to the
patient's rectum and large intestine. SIGMOLUX™ supplies effective illumination thus
permitting direct visual examination by qualified medical personnel within a professional
health facility. An insufflator is attached to assist in this procedure accordingly.
Indication and Patient Group
SIGMOLUX™ is indicated for use when a suitably qualified and experienced Healthcare
Professional is required to perform a direct examination of the large intestine of a non-
contraindicated adult
Not For Paediatric Use
Instructions for Use
1. Examine the pack before use. Remove the device from its packaging by separating the peel
pouch and removing the product. Discard the package. The pack shall not be issued nor the
Sigmoidoscope used if the wrapper or seal is broken. DO NOT USE IF PACKAGING OR
SIGMOIDOSCOPE IS DAMAGED.
2. Check that all parts are correctly attached before usage
3. Pull out the blue tab in the light pack located in the device handle to activate the light
source, before insertion into the patient. Maximum illumination intensity is maintained for a
minimum of 30 minutes. The light pack will operate for a considerably longer period, with
gradually diminishing intensity.
4. Lubricate SIGMOLUX™ with a suitable lubricant starting from the tip of the introducer before
use on the patient.
5. It is advised and may be necessary to empty the rectum with an enema prior to
performing the procedure. The patient should be informed when the Sigmoidoscope is to be
introduced and removed.
6. Hold SIGMOLUX™ by the handle, with your thumb press against the introducer to avoid
introducer shifting back and gently insert the instrument.
7. Once SIGMOLUX™ is placed in position, remove the introducer, close the lens and lock using
the lens latch.
8. The instrument will be airtight when the lens is successfully closed.
9. Start insufflating and move SIGMOLUX™ towards the patient with lateral movements.
10. The lens window can be opened and closed at any time
11. On completion of the investigational procedure, press the button on the insufflator
to release air from the colon. Remove SIGMOLUX™ from the patient with a gentle, lateral
movement.
12. Dispose of the device in an appropriate way as described in the disposal section.
IMPORTANT The lens can be used as protection against any unwanted material falling inside
the Sigmoidoscope. If the examination is not being conducted and the Sigmoidoscope is still
inserted, it is highly recommended to close the window. IMPORTANT Any serious incident that
has occurred in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
Contraindications
Acute peritonitis Acute Severe Diverticulitis
Recent Colonic Surgery
Colonic Necrosis
Fulminant Colitis Toxic Megacolon
Griffiths and Nielsen Ltd.
Maydwell Avenue, Stane Street, Slinfold,
Horsham, RH13 0GN, UK
INSTRUCTIONS FOR USE
Model Size Product Code
One SIze 701000
Diverticular Abscess
Anal Fissure
T: +44 (0)1403 799190
E: medsales@gandn.com
www.gandn.com
Do not re-use
Catalogue number
Batch number
Use by date
Date of manufacture
Direct electrical current at voltage
shown
Not made with natural rubber
latex
Do not look directly into the light
source
Fragile – handle package
carefully
No DEHP
Medical Device
GMDN 15058
Global Medical Device Nomenclature
Disposal
Discard SIGMOLUX™ with the light pack still attached, as "clinical waste" according to
hospital, or local protocols. Note: If required the light pack can be removed by firmly pulling
the entire pack downwards. Do be careful as it may well release suddenly. Dispose of the light
pack responsibly.
Warnings
Before each use carefully examine the instrument to ensure that there are no visible scratches,
chips, voids, etc. These could cause the instrument to lose its stability potentially
compromising safety. The patient should be informed when the Sigmoidoscope is to be
introduced and removed.
Adjustments may be necessary to provide improved comfort.
WARNING Inspect each device and packaging for damage prior to use
For hygienic reasons always wear surgical gloves when handling the
WARNING
device before and after use. The device will come into contact with
biological fluids which are potentially infectious.
When in transit or storage, device may be subject to damage
WARNING
beyond the control of the manufacturer or supplier.
WARNING Never use device with laser equipment.
Treat used devices as biohazardous infectious material. Dispose of used
WARNING
devices in suitable disposal unit or in accordance with local regulations.
WARNING Device is not compatible with any sterilization method.
WARNING No modification of this equipment is allowed.
Never use an ultrasonic cleaner for the device, the device should not be
WARNING
cleaned or sterilised in any way as it provided in clean hygienic form for
single use only.
FOR SINGLEUSEONLY:
The G&N Medical device is designed for single use only; do not reuse device. G&N does not
have data regarding reuse of this device. Reuse may cause device failure or procedural
complications including device damage, compromised device biocompatibility, and device
contamination. Reuse may result in infection, serious injury, or patient death. After use,
this product may be a potential biohazard. Handle and dispose of in accordance with
accepted medical practice and applicable laws and regulations.
Cautions:
For use by trained healthcare personnel only
Federal (USA), UK and European Union Law restricts this device to sale, distribution and use by
or on the order of a physician.
Storage
Store devices in their original packaging at room temperature and normal air humidity.
CS Lifesciences Europe Limited 3 Inns
Quay, Dublin 7, Ireland
SIGMOLUX
®
Do not use if package is
damaged
Keep dry
Shock protection (Type BF
Applied Part)
Federal or EU Law restricts this
device to be sold by or on the
order of a licensed Health
Practitioner
Warning/caution consult
accompanying documents
Consult instructions for
use/consult operating
instructions
Non-sterile
Manufacturer and address of
the manufacturer
Number of items per
pack
IP rating
Medical Device in conformity with
Regulation (EU) 2017/745
110001/3
05/2021