9.3 Returning the peristaltic pump unit for repair
10 System chart
11 Specifications
11.1 Pump tube characteristics
11.2 Technical data
12 Electromagnetic compatibility (EMC)
12.1 Guidance and manufacturer’s declaration – electromagnetic emissions
12.2 Guidance and manufacturer’s declaration – electromagnetic immunity
12.3 Recommended separation distances between portable and mobile high
frequency communication equipment and the peristaltic pump unit
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WB135745-W10
Olympus AFU-100 ENInstructions for Use
1 Important information
1.1 Intended use
The AFU-100 is a peristaltic pump unit intended for irrigation of instruments or irrigation
/ flushing / cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or
therapy.
Contraindications:
The peristaltic pump unit must not be applied for intravenous fluid administration.
1.2 Instructions for use
These instructions for use contain essential information on using this peristaltic pump
unit safely and effectively. Before use, thoroughly review these instructions for use and
the instructions for use of all equipment which will be used during the procedure. Use
the equipment as instructed. Keep this and all related instructions for use in a safe,
accessible location. If you have any questions or comments about any information in
these instructions for use, please contact Olympus or your distributor.
1.3 User qualification
The user must be a physician or medical personnel under supervision of a physician
and must have received appropriate training in using this peristaltic pump unit. These
instructions for use, therefore, do not explain or discuss medical procedures.
In addition, the user must undergo an instruction / training for the use of this unit. The
instruction / training will be provided by authorised representatives of Olympus or your
distributor during installation and commissioning.
Federal Law of the USA restricts this device to use by, or on the order of, a
physician.
1.4 Peristaltic pump unit compatibility
Refer to chapter 10 (System chart) to confirm that this peristaltic pump unit is
compatible with the ancillary equipment being used. Using incompatible equipment can
result in patient injury and / or equipment damage.
1.5 Repair and modification
This peristaltic pump unit does not contain any user-serviceable parts. Do not
disassemble, modify, or attempt to repair it; patient or user injury and / or equipment
damage may result. Repairs must only be carried out by Olympus or a firm authorised
by Olympus. Some problems that appear to be malfunctions may be corrected by
referring to chapter 9 (Troubleshooting). If the problem cannot be resolved using the
information in chapter 9, contact Olympus or your distributor.
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Instructions for Use ENOlympus AFU-100
1.6 Signal words
The following signal words are used throughout these instructions for use:
DANGER
d
WARNING
CAUTION
Indicates an imminently hazardous situation which, if not avoided, will
result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could
result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury. It may also be used to alert against
unsafe practices or potential equipment damage.
NOTE
Indicates additional helpful information.
1.7 Danger, warnings and cautions
Follow the dangers, warnings and cautions given below when handling this peristaltic
pump unit. This information is to be supplemented by the dangers, warnings and
cautions given in each chapter.
User-related error prevention
WARNING Improper use
The safety and effectiveness of medical procedures depends not only on the design of
the equipment used, but also to a major extent on factors which are under the control of
the user. It is therefore extremely important to read, understand and follow the
instructions supplied with the peristaltic pump unit and the accessories in order to
ensure safety and effectiveness.
Always use the peristaltic pump unit as outlined in these instructions for use. Improper
use will not only impede functions and prevent optimum performance, but may cause
equipment damage and / or complications. Before each use, always inspect the
equipment as outlined in these instructions for use.
6
WB135745-W10
Olympus AFU-100 ENInstructions for Use
with e
Environmental conditions
CAUTION Interference of the unit with other equipment
Be sure that this peristaltic pump unit is not used adjacent to or stacked with other
equipment (other than the components of this peristaltic pump unit or system) to avoid
electromagnetic interference.
Before use, thoroughly confirm the compatibility of all equipment.
To ensure electrical safety, the peristaltic pump unit should not be used in conjunction
quipment whose safety in combined use is not guaranteed.
The peristaltic pump unit complies with the electromagnetic compatibility (EMC)
standard. Nevertheless, when the peristaltic pump unit is active it may disturb
neighboring electronic equipment. Follow the instructions in chapter 12 (Electromagnetic
compatibility) regarding electromagnetic ambient conditions.
Do not use the peristaltic pump unit in a location exposed to strong electromagnetic
radiation (microwave or short-wave medical treatment equipment, Magnetic Resonance
Imaging, radio or mobile phone equipment). Peristaltic pump unit malfunction can occur.
CAUTION Unsuitable temperature and humidity
The peristaltic pump unit should only be used under the conditions as described in
chapter 11.2 (Technical data). Use under other conditions may impede normal
performance and / or result in equipment damage.
Accessories
WARNING Mechanical stress
Do not apply excessive bending, straining, or squeezing force to any cords or tubes. It
may cause malfunction.
CAUTION Non-compatible accessories and accessory damage
The peristaltic pump unit may only be used with compatible accessories.
Before use, the peristaltic pump unit and accessories must be examined for damage. All
communication cables and its plugs must be free of scratches and cracks. Cables and
accessories with damaged insulation or connections must not be used.
Electric shock
WARNING Grounding failure
To prevent the risk of electric shock, the housing of the peristaltic pump unit must be
grounded. Always connect the power cord plug to a properly grounded wall outlet. Do
not use a 3-pin / 2-pin adapter, as it can impair safe operation of the unit.
WARNINGUser shock
To prevent user shock, malfunction and damage of the peristaltic pump unit, keep
liquids away from all electrical equipment. If liquid gets on or into the peristaltic pump
unit, terminate operation immediately and contact Olympus or your distributor.
CAUTIONInjury during servicing
When the housing is opened, there is a danger of electric shock. The unit must only be
serviced by authorised technicians.
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7
Instructions for Use ENOlympus AFU-100
Fire / Explosion
DANGER Explosion
This peristaltic pump unit is not explosion-proof. Do not use the unit within an explosion
zone.
WARNING Risk of fire
Disconnect the power plug before changing the fuses! Replace fuses as marked. The
fuses must only be replaced by authorised technicians.
WARNINGIgnitable cleaning- and disinfection agents
Flammable agents used for cleaning and disinfection must be allowed to evaporate
before the peristaltic pump unit is used.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
Procedural hazards and complications
DANGER Procedural hazards and complications
The safety of medical procedures will be greatly enhanced by a thorough knowledge of
the medical literature on the subject. Study of specific information on the hazards and
complications of the procedure in question is especially recommended.
WARNINGFlow performance
If the peristaltic pump unit fails and the flow is stopped during treatment, it may be
impossible to finish the treatment.
Should any abnormal flow be suspected during operation, immediately terminate the
use of the peristaltic pump unit. If deactivation is not possible, switch off the peristaltic
pump unit. Otherwise, malfunction of the equipment may cause an unintended increase
in the flow.
CAUTIONUnit defect
In the event of a defect or malfunction in the unit, an undesirably high flow output may
occur.
8
WB135745-W10
Olympus AFU-100 ENInstructions for Use
2 General description
The AFU-100 peristaltic pump unit is a roller pump. The rollers of the pump rotors
squeeze the inserted pump tube so that the liquid in the pump tube is transported. This
enables liquid media to be transported without coming into contact with the peristaltic
pump unit. Sterile liquids (e.g. isotonic saline solution) thus remain sterile, provided that
a sterile tube set is used.
The maximum flow rate is 270 ml and 600 ml per minute with two different tube sets
(see chapter 11.1, Pump tube characteristics) offered as single use items. In addition,
three memory buttons provide fast access to preset flow levels. The peristaltic pump
unit can be connected to an electrosurgical unit by an interface, allowing operation of
the peristaltic pump unit by a special button on the electrosurgical unit’s footswitch.
The pump rotor is equipped with a protective cover, which automatically stops the
rollers from rotating if it is opened while the peristaltic pump unit is activated, and thus
prevents possible injuries.
3 Inspection prior to use
Verify that all items shown below are contained in the package. Inspect each item for
damage. If the peristaltic pump unit is damaged, a component is missing or you have
any questions, do not use the peristaltic pump unit. Contact Olympus or your distributor
immediately.
Peristaltic pump unit
Instructions for use
Communication cable
Pump head
Power cord
The following items are optional and may be purchased separately from Olympus or
your distributor:
• Footswitch
• Pump tube
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Instructions for Use ENOlympus AFU-100
M2
4 Symbols, definitions and functions
4.1 Symbols and descriptions
4.1.1 Front panel
Power on / off
Caution
Defibrillation proof type CF applied part
(cardiac application)
Up (increase flow level)
Down (decrease flow level)
Flow on / off
Flow activation
Communication assignment with an
electrosurgical unit
Communication assignment with footswitch
Do not allow fingers to contact moving parts
Memory 1
Memory 2
Memory 3
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WB135745-W10
Olympus AFU-100 ENInstructions for Use
4.1.2 Rear panel
Manufacturer
Date of manufacture
Serial number
Reference number
Indication of the direction of higher volume
Loudspeaker
Footswitch connection
Interface for electrosurgical unit connection
Operating instructions
Waste electrical and electronic equipment
Fuse
Product carries the CE mark
WB135745-W10
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