Device Description - Smith & Nephew SPIDER2 Modo De Empleo

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SPIDER2 Limb Positioner

Device Description

The SPIDER2 combines strength and flexibility to provide optimal intraoperative positioning.
The SPIDER2 has been designed to attach to the rail on all standard operating room tables, as
well as the rail on the back of the T-MAX Beach Chair Positioner.
Intended Use
The Smith & Nephew Limb Positioner is intended for use during surgical procedures to attach
to the rail of standard operating room tables, or T-MAX Beach Chair Positioner to maintain
patient limb position during surgical procedures.
Indications for Use
The SPIDER2 is used to position limbs during surgical procedures.
Contraindications
None
Warnings
• Failure to do the following may result in injury to the patient and/or health care
professional.
• It is the responsibility of health care professionals to be familiar with appropriate
surgical techniques. Prior to using SPIDER2 the Instructions for Use must be read
and understood, paying special attention to warning information. Failure to take
adequate care may result in injury to the patient and/or health care professional.
• Read and understand the particulars of the Instructions for Use for the specific
accessory being used. Do not use the system without having read and understood
all relevant Instructions for Use.
• Surgery specific Instructions for Use contain further warnings; refer to appropriate
Instructions for Use prior to use of the product.
• The SPIDER2 system has been tested and found to comply with the emission
and immunity limits for medical devices to the IEC 60601-1-2 and Medical Device
Directive 93/42/EEC. Compliance to the limits is intended to provide reasonable
protection against harmful interference in a hospital environment. There is no
guarantee that interference will not occur in an installation. If the SPIDER2 does
cause harmful interference to other devices, it is recommended that the user
attempt to correct the interference by one or more of the following actions:
Reorient or relocate this equipment, the other equipment, or both.
–
– Increase the separation between the pieces of equipment.
– Consult a biomedical engineer.
• Prior to each use equipment and components are to be inspected for damage.
• Prior to each use inspect plastic enclosure for any damage that could result in fluid
entry.
• Do not use any damaged components. Damaged equipment or components may
result in injury to the patient and/or health care professional.
• Load on SPIDER2 is not to exceed 50 lbs (23kg). Failure to comply may result
in patient and/or health care staff injury. Specific SPIDER2 orientations can
accommodate higher loads; contact Smith & Nephew.
• Joints of SPIDER2 cannot be locked or unlocked without a battery in place.
• The SPIDER2 Setup Button is disabled when the switch drape and/or foot pedal are
plugged in.
• If Switch Drape Button is connected to the limb, do not disconnect patient's limb
from SPIDER2.
• Always hold the SPIDER2 and/or patient's limb while positioning the SPIDER2.
• No modifications to this equipment are allowed.
• If changing batteries during a surgical procedure, do not change the state of the
Power Switch. Doing so during surgery may cause the SPIDER2 to release pressure
causing unwanted movement.
• Do not change the state of power switch if the patient is connected to the SPIDER2.
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126-99-01 Rev. H
• Do not grasp the SPIDER2 over the quick connect release buttons as this can
disengage the quick connect locks and disconnect the patient's limb from the
SPIDER2.
• Do not release the SPIDER2 and/or patient's limb until you are certain the SPIDER2
has locked.
• Ensure all cables are routed to avoid damage. Damaged cables must be replaced.
Failure to replace cables may result in injury to patient and/or health care staff.
• Single use stabilization kits are not to be reused or used if packaging has been
damaged. Failure to comply may result in patient injury and/or infection.
• If SPIDER2 motor runs continuously, or runs more than once per minute while in
locked state, disconnect patient and have product serviced.
• Do not allow fluids to enter the switch drape connection receptacle or the foot
pedal connection receptacle.
• Use Foot Pedal with Smith & Nephew products only.
• Do not use in AP = Anaesthesia proofed and G = Gas (AP, APG, IEC 60601-1), and
OEA = oxygen-enriched atmosphere environments.
• Do not use solvents, lubricants, or other chemicals unless otherwise specified.
• Use SPIDER2 battery charger with SPIDER2 battery pack REF 72203301. Other types
of batteries may burst, causing personal injury and damage to charger.
• The SPIDER2 battery charger is not permitted to be used in patient care areas due
to leakage current. Failure to comply could result in injury to the patient and/or
health care professional.
• The SPIDER2 battery charger is not suitable for the use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• The SPIDER2 battery charger is for indoor use only.
• Replace defective SPIDER2 battery charger cords and wires immediately.
• The socket-outlet shall be installed near the SPIDER2 battery charger and shall be
easily accessible.
• Use of accessories or cables with this equipment, other than those specified
or provided by the Smith & Nephew, could result in increased electromagnetic
emissions or decreased electromagnetic immunity and result in improper operation.
• Electrical Interference. This equipment is designed to be used as a stand-alone,
in proximity too, and with other medical equipment. This equipment and the other
equipment should be observed to verify that they are operating normally.
• Abnormal performance, due to Electromagnetic Disturbances, may be manifested
by a failure to properly maintain positioning of the limb.
• High Frequency (HF) Interference: This equipment was designed and tested to be
used with HF Electrical Surgical Unit (ESU) equipment.
• Essential Performance. Hydraulic pressure cannot drop unexpectedly without
adequate notice so that practitioner has time to switch to a more traditional means
of maintaining damaged joints or bone fractures separated during the surgical
procedure.
Precautions
U.S. Federal law restricts this device to sale by or on the order of a physician.
• Do not store SPIDER2 in locked position as this will drastically reduce the life expectancy
of device. Depressurize before storing by turning Power Switch to the DEPRESSURIZE
Position for 1 second and then allowing the Switch to return to the OFF Position.
SPIDER2™ Limb Positioner
Instructions for Use