Device Description; Indications For Use; Prior To First Use - smith&nephew SPIDER2 Modo De Empleo

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.

Indications for Use

The SPIDER2 is used to position limbs during surgical procedures.
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 the affected device(s)
– Increase separation between SPIDER2 and affected device(s)
• 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.
• 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, APG and OEA environments.
SPIDER2 Limb Positioner Instructions for Use
• 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 must not be used in the vicinity of flammable
anesthesia gases.
• 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.
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. Always 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.
Components
Figure 1. SPIDER2
1. Quick Connect Release Button
3. Indicator Light
5. Drape Clips
7. Switch Drape Connection Receptacle
9. Dumbbell Joint
11. Battery
13. Clamp Indexing Handle
15. Power Switch

Prior to First Use

1. Charge SPIDER2 battery prior to first use, batteries provided are not fully charged.
2. Once fully charged, attach battery to SPIDER2.
3. Turn Power Switch to ON Position (Figure 1); SPIDER2 will be activated and all joints will
lock.
English
2. Female Quick Connect
4. Battery Release Button
6. Foot Pedal Connection Receptacle
8. Set Up Button
10. Hinge Joint
12. Clamp Actuating Knob
14. Distal Joint
126-99-01 Rev. C
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