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PROFESSIONAL MEDICAL PRODUCTS
PROCTOSCOPIO
PROCTOSCOPE
Manuale d’uso - User manual
È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi fornito al
fabbricante e all’autorità competente dello Stato membro in cui si ha sede.
All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and
competent authority of the member state where your registered ofce is located.
29405
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Pakistan
M29405-M-Rev.1-07.20
ITALIANO
Leggere attentamente queste istruzioni prima di utilizzare il proctoscopio e conservarle per una futura
consultazione.
Attenzione
L’utilizzatore deve leggere attentamente le istruzioni contenute in questo manuale al ne di ottenere
sempre prestazioni ottimali dallo strumento e per mantenere lo stesso afdabile nel tempo.
Controllare il contenuto della scatola contenente il proctoscopio, per assicurarsi che tutti i componenti
necessari siano presenti e che siano in perfette condizioni.
INDICAZIONI D’USO
Il proctoscopio è uno strumento utilizzato per esaminare e per il trattamento del passaggio anale.
CARATTERISTICHE DEL PRODOTTO
Questi proctoscopi sono dotati di un’illuminazione a bre ottiche, che consente la costante illuminazione
del passaggio anale e ne facilita l’esaminazione.
Questo proctoscopio può essere utilizzato sia con fonte di luce alogena da 120 watt, oppure con un più
compatto ed economico manico porta luce da 6,0 volt.
Lo strumento è realizzato in acciaio inox 18/8 inossidabile ed è stato testato durante tutte le operazioni
di pulizia e disinfezione standard.
Avvertenze
Il proctoscopio deve essere montato con l’otturatore, che successivamente deve essere bloccato. Il
cono dell’otturatore e il tubo devono essere accuratamente lubricati, prima dell’utilizzo.
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Read these instructions carefully before using the proctoscope and keep them in a safe place for future
reference.
Attention
The operator/user must carefully read and understand this manual thoroughly to keep the product performance durable and reliable for longer period.
After opening the packaging, rst of all it is necessary to check all the components against the standard
conguration. Check that they are all present and in perfect conditions.
INDICATIONS FOR USE
Proctoscope is an instrument primarily used for examination and treatment of the anal passage.
FEATURE
These proctoscopes have anular F/O illumination hence the anal passage is evenly illuminated for
easier examination.
These proctoscope can be powered either with a powerful 120 watt Halogen light source, or by a more
compact and economical 6.0 volt lamp handle. These proctoscopes are made from 18/8 type stainless
steel making them rust proof and most stable under cleaning and disinfection process.
Cautions
Proctoscope must be inserted with obturator, securely locked. The cone of the obturator and the tube
must be lubricated with suitable lubricant before use.
USAGE
Check that all parts are correctly attached before usage. All proctoscopes are supplied with ACMI and
Wolf connection. The instrument must be used by qualied medical personnel within a professional
health facility.
A STORZ connector is also supplied in the package, allowing multiple connect ability options.
Attach a F/O cable to a light source and then attach the coupling adaptor to the proximal end of the
adaptor on this proctoscope as shown in g. 1.
If a light source is not available, a lamp handle with a direct main adaptor and a 6.0 volt halogen lamp
can be used as shown in g. 2. An add-on type F/O handle can also be used with the F/O cable which
can then act as the handle for these proctoscopes. Align the black mark on the handle with a similar
mark on the proctoscope to achieve proper locking. The handle is locked onto the proctoscope by
twisting the knob towards right. For unlocking, twisting the knob towards left and pull down the handle.
Attach the Tube to the front side of head and make sure tube is rmly screwed in as illustrated in Fig 3.
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Black mark
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Lamp handle
Fig. 2
Insert the obturator in the proctoscope tube by aligning the Distal end slot onto the ber optic guide
inside head part & x it in F.O. head as show in g 4. Apply a lubricant to the cone and insert in anal
passage way. Remove the obturator by aligning the slot again and pull out the obturator. Now the instru-
ment is ready for use. Turn on the light to light up the passage and perform examination and treatment.
If magnication of the object is required, insert the swivel lens in to one hole provided.
Important
Obturator can be used as a protection against any unwanted material falling inside the proctoscope. So
if the examination is not being conducted and the proctoscope is still inserted, it is highly recommended
to put the obturator in tube.
Connector
F/O Cable
Fig. 1
Fig. 3
Fig. 4
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INSUFFLATION BULB
(NOT INCLUDED IN THE PRODUCT)
COD. 29427
Use of the rubber insufation bulb
Always use the Hygiene Filter (2) when connecting
the rubber insufation (1) bulb to the Proctoscope
/ Anoscope / Sigmoidoscope. These lters are
intended for single use only and prevent internal
contamination of the rubber insufation bulb. For
sufation port on the Proctoscope / Anoscope / Sigmoidoscope. Control the connection between the
transparent hose and the Hygiene Filter. If it isn’t securely attached, x it more tightly. Then connect the
Hygiene Filter to the rubber insufation bulb.
Caution! Don’t disassemble the insufation bulb.
Caution! Infection! The use of the instrument without the Hygiene Filter may lead to contamination of
the rubber insufation bulb and thereby to an infection of the following patients.
Therefore, always use the lter. If you have forgotten to use the lter, replace the rubber insufation
bulb. If there is a risk of contamination inside the twin bellow insufator, the twin bellow insufator has
to be replaced and disposed.
Risk of allergic shock: The rubber double bellows contain natural rubber latex. Do not use it in patients
with a latex allergy.
Caution! Infection! The lter is a single use product. If it is reused, the risk of infection increases. The
lter is not suitable for being cleaned, disinfected and sterilized.
Cleaning / Disinfection of insufation bulb
1. Residues and other deposits must be removed immediately after use to avoid any residues drying
on to the surface
2. Autoclave is not recommended, this may damage the insufation bulb
3. Use surface cleaner e.g. Isopropyl alcohol (IPA), for the disinfection of insufation bulb.
this, connect the transparent hose (3) to the in-
CARE AND MAINTENANCE OF OBTURATOR
Cleaning
Clean immediately after use to prevent the drying-on of residues. We recommend washing with a soft
brush and soapy or plain water. If machine washing or chemical cleaners are used, the manufacturer’s
instructions regarding duration and concentration must be followed. No ultrasonic cleaning. After clean-
ing, rinse thoroughly with demineralised water and dry at 65°C max.
Disinfection
We recommend soaking in disinfectant or thermochemical disinfection at up to 65°C in a washer sterilizer. Adhere strictly to manufacturer’s instructions regarding concentration and duration. After disinfection,
rinse with sterile water and wipe dry with a sterile cloth.
STERILIZATION
After cleaning the components can be gas-sterilized with ethylene oxide at up to 65°C. Autoclaving can
be used occasionally, but repeated autoclaving will reduce light transmission and life expectancy of the
optical bers. Flash autoclaving and hot air sterilization are not recommended.
Gas Sterilization
Gas sterilization by Ethylene oxide up to a maximum temperature of 65°C and 8 psi may be performed,
which is preferred especially if sterilization is to be performed regularly.
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Autoclave
In order to perform Autoclave kindly refer to below mentioned table:
Temperature 121°C (250 °F) 134°C (270 °F)
Cycle Time 30 Min 5 Min
Dry Time 15 Min 20 Min
(A) GRAVITY DISPLACEMENT STEAM B) PRE-VACUUM STEAM
Recommended operating environments
Operation
Altitude 0-13123 feet (0-4000 meters)
Storage & Transport
Temperature 10°C - 35°C
Humidity 30% - 75%
Air pressure 700 hPa – 1060 hPa
Temperature -20°C - 50°C
Humidity 10% - 90% (without condensation))
Air pressure 500 hPa – 1060 hPa
INDEX OF SYMBOLS
Caution: read instructions (warnings)
carefully
Keep in a cool, dry place Keep away from sunlight
Product code Lot number
Manufacturer Date of manufacture
Consult instructions for use Medical Device
Medical Device compliant
with Regulation (EU) 2017/745
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GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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