INSTRUCTIONS FOR USE
PERISTALTIC PUMP UNIT
AFU-100
REF: WB950167 (100…240 V~)
WB135745-W10
Olympus AFU-100 |
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Instructions for Use |
Contents
1Important information
1.1Intended use
1.2Instructions for use
1.3User qualification
1.4Peristaltic pump unit compatibility
1.5Repair and modification
1.6Signal words
1.7Danger, warnings and cautions
2General description
3Inspection prior to use
4Symbols, definitions and functions
4.1Symbols and descriptions
4.1.1Front panel
4.1.2Rear panel
4.1.3Packaging
4.1.4Pump tube
4.2Front panel
4.2.1Buttons / Switches
4.2.2Indicators
4.2.3Displays
4.3Rear panel
5Accessories
5.1Footswitch
5.2Pump tube
6Installation and commissioning
6.1Installation of equipment
6.2Connection / disconnection of pump head
6.3Connection to an AC mains power supply
6.4Equipotential bonding
6.5Connection of footswitch
6.6Connection to an electrosurgical unit
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7Operation
7.1Power supply
7.2Acoustic signals and tone volume adjustments
7.3Pump tube insertion and connection
7.4Flow selection
7.5Store and recall flow levels
7.6Activation / deactivation of the flow
7.7Procedure after use
8Cleaning, storage and disposal
8.1Cleaning
8.2Storage
8.3Disposal of the unit
9Troubleshooting
9.1Error codes and measures
9.2Periodic safety checks
9.3Returning the peristaltic pump unit for repair
10System chart
11Specifications
11.1Pump tube characteristics
11.2Technical data
12Electromagnetic compatibility (EMC)
12.1Guidance and manufacturer’s declaration – electromagnetic emissions
12.2Guidance and manufacturer’s declaration – electromagnetic immunity
12.3Recommended separation distances between portable and mobile high frequency communication equipment and the peristaltic pump unit
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WB135745-W10 |
Olympus AFU-100 |
EN |
Instructions for Use |
1Important information
1.1Intended 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.
1.2Instructions 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.
1.3User 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.
1.4Peristaltic 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.
1.5Repair 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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1.6Signal words
The following signal words are used throughout these instructions for use:
DANGER Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION 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.
1.7Danger, 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.
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Instructions for Use |
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 with equipment 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.
WARNING User 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.
CAUTION Injury 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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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.
WARNING Ignitable cleaningand 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.
WARNING Flow 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.
CAUTION Unit defect
In the event of a defect or malfunction in the unit, an undesirably high flow output may occur.
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Instructions for Use |
2General 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.
3Inspection 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 |
Pump head |
Instructions for use Communication cable |
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 |
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4Symbols, definitions and functions
4.1Symbols and descriptions
4.1.1 Front panel
M1
M2
M3
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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Instructions 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
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