Depuy Mitek 227214 Wireless Footswitch User Manual
Depuy Mitek Wireless Footswitch Users Manual
Users Manual
Manufactured for DePuy Mitek by:
Gyrus Medical P/N: 192055-DC
VAPR VUE®
Wireless
Footswitches
P/N: 110008
Rev: H Revised 08/2017
© DePuy Synthes 2010-2017.
All rights reserved.
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ENGLISH
VAPR VUE®
Wireless Footswitch
INSTRUCTIONS FOR USE
Please read the VAPR VUE® User Manual carefully
prior to using the device. The User’s Manual is
provided with the VAPR VUE Generator. The various
components of the VAPR System are designed to
be used together as a single unit. Failure to properly
follow instructions may lead to electrical or thermal
injury and result in improper functioning of device.
IMPORTANT: This package insert is designed
to provide instructions for use of the VAPR VUE
Wireless Footswitch. It is not a reference to
electrosurgical technique.
IMPORTANT: Use only DePuy Mitek VAPR
Electrodes and accessories with the DePuy Mitek
VAPR VUE System.
INDICATIONS
The VAPR VUE Wireless Footswitch (transmitter)
is wirelessly paired with the VAPR VUE Generator
(receiver) to activate the electrosurgical system.
WARNINGS
1. Explosion hazard – Do not use this equipment in
the presence of flammable anesthetics.
2. Explosion hazard – Because of battery operation,
there is always the chance of spark generation.
Do not sterilize this equipment with ethylene oxide
or other explosive agents.
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3. The use of ACCESSORY equipment not complying
with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of
the resulting system. Consideration relating to the
choice shall include:
– use of the accessory in the PATIENT VICINITY
– evidence that the safety certification of the
ACCESSORY has been performed in accordance
to the appropriate IEC 60601-1 harmonized
national standard.
4. Periodically, whenever the integrity of the switch is
in doubt, test all functions.
PRECAUTIONS
1. For continued safety and performance of the
footswitch, it is recommended that the functionality
and electrical safety of the footswitch be verified
on an annual basis by an authorized DePuy Mitek
representative.
2. The footswitch should be inspected every day or
before use.
3. The VAPR VUE Wireless Footswitch operates on a
frequency range of 2.405-2.480 GHz. It should be
tested to assure compatibility with the environment
it is working in.
4. Replace the batteries in the transmitter with
high quality “AA” size 1.5-volt alkaline batteries
(IEC LR6) with a rated capacity of no more than
2000mAh. Do not fit Lithium, Zinc or re-chargeable
batteries. Never mix manufacturers when replacing
the batteries. Never mix old and new batteries.
Care must be taken when replacing the batteries
not to damage the O-ring seal on the battery cover.
5. The O-ring seal should be replaced whenever it
is damaged or its integrity is in question. DePuy
Mitek recommends the seal should be replaced at
a minimum every third time batteries are replaced.
When replacing the seal lubricate it with petroleum
jelly.
6. If the VAPR VUE Wireless Footswitch will not be
used for an extended period of time, remove the
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batteries to prevent damage due to possible battery
leakage.
7. Follow the battery manufacturer’s recommendations
or your health care facility’s policy for the disposal
of used batteries.
Report all problems experienced with the footswitch.
If the footswitch is not working properly, contact your
DePuy Mitek service representative for service. The
footswitch should not be used if it is not working
properly.
Changes or modifications not expressly approved by
DePuy Mitek could void the user’s authority to operate
the equipment.
IMPORTANT
1. If the receiver (part of the VAPR VUE Generator)
does not receive a signal from the transmitter
(part of the VAPR VUE Wireless Footswitch) for a
period of 525 milliseconds, RF activation will no
longer be possible. However, once reception is
restored, the VAPR VUE Wireless Footswitch will
function normally.
2. The VAPR VUE Wireless Footswitch transmits in
all directions. However, every application is different
and you may need to adjust the positions of the
VAPR VUE Wireless Footswitch or VAPR VUE
Generator to obtain optimal performance.
3. Multiple VAPR VUE Wireless Footswitches and
VAPR VUE generators may be used in the same
vicinity. At any one time, each VAPR VUE Wireless
Footswitch can be paired with one and only one
VAPR VUE generator.
4. If the footswitch is tipped 60 degrees or more or
disturbed in such a way as to activate the internal
tip switch, the footswitch will be inoperable until it is
stabilized (in 2 seconds).
5. A backup means for activation should be available
(i.e., second wireless footswitch, wired footswitch,
or electrode with hand controls).
6. The footswitch should be stored with the pedals
facing up. The battery life is significantly reduced if
the footswitch is stored upside down or sideways.
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7. Ensure the pedals and mode button are not
depressed when stored. Battery life will be
significantly reduced.
INSTRUCTIONS FOR USE
Place the wireless footswitch in a clear, sealable
plastic bag prior to use. Refer to the VAPR VUE User
Manual on how to pair and operate the VAPR VUE
Wireless Footswitch with the VAPR VUE Generator.
Cleaning the VAPR VUE WIRELESS
Footswitch
The wireless footswitch is IP68 rated and can be
completely immersed briefly. Do not use abrasive
cloths, sharp objects, or abrasive cleaners. Dampen a
non-abrasive cloth with one of the following products;
then wring out until slightly wet and gently rub soiled
area until clean.
– Soap and water
– Cidex
– Sodium Hypochlorite 5.25% (Bleach) diluted 10:1
DO NOT AUTOCLAVE OR USE ETHYLENE OXIDE
on Wireless Footswitch
General Information
If the foot switch is cold to the touch or below ambient
temperature, allow it to reach room temperature
before use.
ELECTROMAGNETIC INTERFERENCE
• This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
– This device may not cause harmful interference
and
– This device must accept any interference
received, including interference that may cause
undesired operation.
• This equipment complies with FCC radiation
exposure limits set forth for an uncontrolled
environment. End users must follow the specific
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operating instructions for satisfying RF exposure
compliance. This transmitter must not be co-located
or operating in conjunction with any other antenna
or transmitter.
• Changes or modifications not expressly approved by
the party responsible for compliance could void the
user’s authority to operate the equipment.
• This device has been tested and found to comply
with the limits for medical devices to the EN 60601-
1-2, Medical Device Directive 93/42/EEC. These
limits are designed to provide reasonable protection
against harmful interference in a typical medical
installation. However, because of the proliferation of
radio-frequency transmitting equipment and other
sources of electrical noise in the health-care and
home environments it is possible that high levels of
such interference due to close proximity or strength
of a source may result in disruption of performance
of this device.
• This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used
in accordance with these instructions, may cause
harmful interference with other devices in the vicinity.
Disruption or interference may be evidenced by
erratic or incorrect functioning. If this occurs, the site
of use should be surveyed to determine the source
of this disruption, and actions taken to eliminate the
source. The user is encouraged to try to correct the
interference by one of the following measures:
– Turn equipment in the vicinity off and on to
isolate the offending equipment.
– Reorient or relocate the other receiving device.
– Increase the separation between the interfering
equipment and this equipment.
– If assistance is required, contact your
DePuy Mitek Representative.
• The wireless footswitch, in conjunction with the
DePuy Mitek VAPR VUE generator, has been tested
and found to properly operate in the presence of the
following potentially interfering devices:
– Electrosurgery generators – located on the same
cart as the VAPR VUE generator
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– Wi-Fi devices – minimum 3 feet away from
VAPR VUE generator and wireless footswitch
– Bluetooth device – minimum 3 feet away from
VAPR VUE generator and wireless footswitch
– Wireless phones (2.4 GHz) – minimum 3 feet
away from VAPR VUE generator and wireless
footswitch
– Microwave ovens – minimum 20 feet away from
VAPR VUE generator and wireless footswitch
– Other VAPR VUE Wireless footswitches – no
minimum distance from VAPR VUE generator
and wireless footswitch
Battery Replacement Transmitter
A
BC
D
E
F
G
Name Description
A 2X Locking Tabs
B Battery Cover
C Slotted drive ¼ turn fastener
D O-Ring seal
E 3X “AA” Alkaline batteries
F Recessed area for cover removal. Gently
pry with flat tip device to remove cover
G 3X Battery polarity indicator on bottom
face of holder
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BATTERY REPLACEMENT
1. Turn the slotted screw (C) ¼ turn counter-clockwise.
2. Remove the battery cover (B) by gently prying with a
flat tip device in the recessed area near the screw.
Be careful to not damage the O-ring seal (D).
3. Remove and properly dispose of old batteries.
4. Insert 3 fresh “AA” alkaline batteries, observing the
polarity markings on the battery holder (G).
5. Observe the O-ring seal for any damage and
replace if necessary.
6. Carefully replace the battery cover, ensuring the
2 locking tabs (A) go into their seating position.
7. Press the battery cover down so it is flush with the
recessed lip.
8. Turn the slotted screw (C) ¼ turn clockwise.
9. Pairing of the footswitch to the VAPR VUE
generator should not be required after changing
batteries. If pairing is necessary, follow pairing
directions in the VAPR VUE User Manual.
SPECIFICATIONS
• Range: Typically 50 feet
• 2.405 - 2.480 GHz, Channels 1-15
• Latency: Typically 50 milliseconds
• Transmitter battery life: 400 hours @ 50% Duty
cycle. Typical Transmitter Stand-by current: 20μA.
Typical battery life is 1 year, based on average use.
• Degree of Ingress Protection: IP68 per EN 60529
• Transport & Storage Conditions
– Ambient Temperature Range:
14 to 104°F (–10 to 40°C)
– Relative Humidity:
10% to 85%, non-condensing
– Atmospheric Pressure:
500 to 1060 millibars
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• Operating Conditions
– Ambient Temperature Range:
50 to 104°F (10 to 40°C)
– Relative Humidity:
30 – 75%, non-condensing
– Atmospheric Pressure:
700 to 1060 millibars
SAFETY COMPLIANCE
• EN 60601-1 Medical Electrical Equipment,
Part 1: General requirements for basic safety and
essential performance
EMC STANDARDS
• EN 60601-1-2 General requirements for basic safety
and essential performance – Collateral standard:
Electromagnetic compatibility – Requirements and
tests
SIZE
14.0 in (35.6 cm) x 10.0 in (25.4 cm) x 3.0 in (7.6 cm)
WEIGHT
5.5 lbs (2.5 kg) with batteries
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Number of Units
Producto no estéril
Refer to instruction manual/booklet
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US Representative
DePuy Mitek, Inc.
325 Paramount Drive
Raynham, MA 02767, USA
1-800-356-4835
DePuy International Ltd.
St Anthony’s Road
Leeds LS11 8DT England
Tel: +44 113 270 0461
Fax: +44 113 272 4101
*
*
DePuy Mitek, Inc. Medos International SARL
325 Paramount Drive Chemin-Blanc 38
Raynham, MA 02767, USA 2400 Le Locle, Switzerland
1-800-356-4835
* For recognized manufacturer, refer to product label.
P/N: 110008 Rev: H