User's Manual
EN-3
DRAFT
Please read this manual and follow its instructions carefully� The words warning, caution, and note
carry special meanings and should be carefully reviewed:
• Warning: Indicates risks to the safety of the patient or user� Failure to follow warnings may result
in injury to the patient or user�
• Caution: Indicates risks to the equipment� Failure to follow cautions may result in product
damage�
• Note: Provides special information to clarify instructions or present additional useful information�
Warnings
Operator Prole
1� Federal (USA) law restricts this device to sale by or on the order of a physician�
2� The operator of the CrossFlow™ system should be a qualied health care professional having complete
knowledge of the use of this equipment and awareness of the risks associated with arthroscopic
procedures�
3� The operator of the system should be experienced in arthroscopic practices and techniques�
4� The operator of the system should read this manual thoroughly and be familiar with its contents prior to
operating the equipment�
Prior to Surgery
1� Carefully unpack the CrossFlow Integrated Arthroscopy Pump and ensure that all components listed in
the “Package Contents” section of this manual are accounted for and remain undamaged from shipment�
If damage to any component is detected, refer to the standard warranty�
2� Install the system in an operating room that complies with all applicable IEC, CEC, and NEC requirements
for safety of electrical devices�
3� Install and use the system according to the information provided in the “Electromagnetic Compatibility”
section of this manual�
4� If the pump is installed with other equipment in a stacked conguration, observe the pump to verify
normal operation�
5� Portable and mobile RF communications equipment may interrupt system operation� When the
pump is in use, the conducted and radiated electrical elds may interfere with other electrical medical
equipment� If this occurs, power down all electrical equipment not in use, increase distance of other
electrical equipment, and/or connect the pump and other equipment into dierent outlets�
6� Place the pump at the same height as the joint to ensure accurate pressure readings.
7� Ensure the proper connection of the primary power cord of the pump to a grounded receptacle with
the correct mains voltage� To prevent the risk of electric shock, do not use extension cords or portable
multiple socket outlets that are not a part of a certied hospital cart� The use of a portable multiple
socket outlet can lead to a reduced level of safety�
8� Position any cables extending from the pump to avoid contact with the patient, electrodes, other cables,
and any electrical leads which provide paths for high frequency current�
9� Do not connect items which are not specied as part of the system� The use of accessories, transducers,
and cables other than those specied in this manual may result in increased emissions, decreased
immunity of the equipment, or unintended, unsafe operation of the system�
10� Examine all electrical connections to the pump before use� Improper connection may result in
malfunction or unintended surgical eects�
11� Do not touch or insert any objects, other than the cassettes, inside of the cassette holders as this may