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  9. Salter Labs INTUBRITE VLS 6600 Series User manual

Salter Labs INTUBRITE VLS 6600 Series User manual

1
IntuBrite VLS 6600 Series Edge Video
Laryngoscope Operating Instructions
Salter Labs
30 Spur Drive
El Paso, TX 79906 USA
www.salterlabs.com
800-421-0024
customercare@salterlabs.com
L093-0215 Rev E
2
Index
I. Device Assembly and Disassembly 3
II. Operating the VLS 6600 Series Edge Monitor 3
III. VLS 6600 Series Edge System Operation 4
IV. Cleaning Instructions 7
V. Batteries and Battery Maintenance 9
VI. Troubleshooting 10
VII. Warranty Information and Registration 10
3
IntuBrite VLS 6600 Series Edge Video Laryngoscope Operating
Instructions
Intended Use: The rigid laryngoscope is intended for use in
laryngoscopy to examine and visualize the upper airway and glottis.
Please read the instructions carefully before attempting to operate the
VLS 66xx Edge.
I. Device Assembly and Disassembly
1. Select the appropriate VLS video blade or video wand for the
patient.
2. Position the blade or wand connection point to the video handle
mounting block and snap into position by pushing down on the tip of
the blade or wand.
3. If using video wand, slide disposable sheath over wand until it
clicks into place. To remove sheath, unhook from locking tabs and
slide off.
4. Removal of the video blade and wand from handles is
accomplished through reverse of action in Step 2: pulling up on the
tip of the blade and separating the blade connection point from the
handle mounting block.
5. VLS 6630 EDGE PLUS (ONLY) WITH REMOVABLE MONITOR:
Attach monitor to handle by aligning the arrow on the monitor stem
with the blue mark on the handle connector. Gently push- do not
force- the stem into the connector. The stem will lock into position
when fully inserted. Disassembly involves pulling back on the
movable sleeve of the stem and gently separating the monitor from
the handle.
II. Operating the VLS 66xx Edge Monitor
Startup
1. Press, briefly hold and then release the PWR key in the lower left
hand corner of the monitor. The system will then power up and
display the IntuBrite logo for a few seconds, and will then be fully
functional. If a video blade is appropriately fitted to the handle,
an image from the camera will appear on the screen.
2. Upon turning on the monitor, for a few seconds the screen will
project in the lower left hand corner a small battery symbol icon
4
indicating the power level of the handle’s internal rechargeable
lithium battery. The date and time will also be displayed along
with an SD card icon if the SD card is inserted.
3. If the battery is fully charged, the icon will soon disappear. If the
battery is low in power and in need of recharging, the icon will
remain on the screen until the device is either recharged with the
external charger power cord, or power is eventually exhausted
and the monitor turns itself off. The icon will flash when the
battery nears depletion of its power.
III. VLS 66xx Edge System Operation
The VLS Edge is designed to be used with standard laryngoscopy
technique similar to that of direct laryngoscopy. Please refer to
qualified instructors who provide specialized training in endotracheal
intubation techniques before attempting to use this device with human
subjects.
Video Blades and Wands
1.Cleaning: The video blade, wand and handle should be
appropriately cleaned and/or sterilized before use (see cleaning
instructions in PART IV).
2. Anti-Fog: The sapphire lens of the VLS video blade features an
electrical lens heating element which helps eliminate lens fogging
in the warm and humid conditions of the airway. The heating
element is powered by the handle battery, and begins functioning
when the blade is fully engaged with the handle as indicated by
the illumination of the LEDs on the blade. Depending upon the
initial temperature of the blade and other conditions, the lens
should be fully fog-resistant within 45-90 seconds of the
connection of the blade to the handle.
A. Recording, saving and viewing images and video
Still images and video of the airway and intubation procedures
can be recorded and automatically saved to the monitor’s
removable SD card.
Recording still images:
Press the “Snap” icon button on the front of the display. Images
are automatically saved to the SD card under IMGxxxx.JPG
(xxxx starts from 0001 to 9999). If the SD card is full and the
same file name already exists, the old file will be overwritten by
the new file.
5
NOTE: Still images cannot be recorded and saved while the device is
recording video.
Recording Video loops:
• Press the “Rec” icon button once to initiate recording. The
action is noted by an ongoing blinking RED notification on the
display. A recording time counter will also be displayed.
• Press the same button a second time to end the recording. The
video file will automatically be saved to the SD card under an
“.AVI” format.
• If the video recording button is not pushed a second time, the
recording will automatically end after 10 minutes of recording
and the monitor will move to “Preview” mode.
• If the memory card is full prior to recording, the display will
state “Memory Full.” In this case, the user should enter
playback mode to delete files or reformat the card manually.
(See Below)
Accessing images and videos:
• Both still images and video loops can be accessed by pressing
the “Mode” button on the display, and advancing through them
in chronological order by pressing arrow buttons on the display.
• Each file is individually identified by a date/time stamp.
• Video files can be played on the display by pressing the “OK”
button.
• If there are no files on the SD card the screen will display “NO
FILE”.
Deleting Files from SD Card:
Press and release the Mode key, Press and hold the OK key for
approximately 4 seconds. Use arrow buttons to navigate left and
right. Choose “Delete Single”, “Delete All” or “Format.” Press OK
key to confirm.
Brightness Control:
By default, brightness is set at the highest level. By pressing the
OK button on the front of the display, the image will become
dimmer until the desired brightness is reached.
Playing SD Card Files on PC:
6
Remove the micro SD card from the display and insert into the SD
card holder supplied with the unit. Then insert SD card holder into
the PC, using your browser to view the SD card locate files called
DVID. By clicking on the selected file you will be able to view the
file.
The Edge Monitor can also be utilized as a mass storage device.
Simply connect the monitor to a PC with the USB cable. Do not
remove the SD card during this use.
Date/ Time Set Up:
In normal screen mode, press and hold the OK key for 4 seconds
to enter Date/Time setup. Use RT/LF arrow keys to increase or
decrease to desired number, and press OK to advance to the next
numeric value. Press the MODE key to exit the operation.
File Number Reset:
At power up, press and hold the MODE key to reset file number to
IMG0001. xxx. Note that any duplicate files with that number on
the SD Card will be automatically replaced with the new file.
Auto Record Setup:
To enable Auto Record feature hold down the PWR and OK
buttons together while turning on the display. The display will read
AUTO REC ENABLE.
To disable Auto Record feature press and hold down PWR and
OK buttons together while turning on the display. The display will
read AUTO REC DISABLE.
To power off the display in Auto Record mode first press the REC
button which will turn off the record mode, then power down the
display by holding the PWR button for a few seconds then release
and the display will show the message “Goodbye”.
Auto Shut Off:
The VLS 66xx Edge Series comes with an Auto Shut Off feature
preprogrammed into the unit. After 15 minutes of non-use the unit
will automatically shut down to save battery life. However if the
VLS blade or wand is still connected the unit will continue to
illuminate the lights and camera after the monitor shuts down.
7
If the Auto Record feature is enabled the unit will Auto Rec for 10
minutes then revert to the normal 15 minute cycle then shut down.
IV. Cleaning Instructions
Video Handle, Blades and Wands
Reusable laryngoscope video blades must undergo high level
disinfection or sterilization between uses. Laryngoscope video handles
and wands should be cleaned with low level disinfectant between
patients; high level disinfection is optional. Always follow hospital
protocol for cleaning reusable laryngoscope components.
•Detach the video blade or wand from the laryngoscope handle.
If applicable, detach video display from handle prior to cleaning.
•Remove batteries from the handle and replace the cap of
handle.
8
•Clean external surface of the blade, wand and handle with a
damp cloth or soft brush using warm water and soap, isopropyl
alcohol solution or other anti-microbial disinfectant to remove
any deposits. A pH neutral cleaning solutions recommended.
•For high-level disinfection use Cidex® 2.4% glutaraldehyde
solution or similar disinfectant. Follow manufacturer’s usage
instructions. To avoid damage, do not soak handles in
disinfectant or washing solutions for ≥ 20 minutes.
•For sterilization, use Steris® or STERRAD® low temperature
sterilization processing. Temperatures should not exceed 140°F
(53°C) and/or 28 minute cycles. Refer to Table 1.
NOTE:
•Given the electrical componentry, the video blade should not be
exposed to extreme temperatures during cleaning.
•DO NOT AUTOCLAVE THE VIDEO HANDLE, BLADE OR WAND.
•Do not use abrasive cleaning techniques or ultrasonically clean.
•Ensure the handle, blade and wand are dry & fully checked prior
to storage
Handles, blades and wands should always be tested after cleaning
and prior to use.
Disposable Sheath
The sheath is disposable and intended for single patient use. Do not
reuse or sterilize. Dispose of after each use.
Video Accessories
All cables and other ancillary devices should be cleaned by wiping with a
70% isopropyl alcohol solution, or a mild detergent and water.
Do not immerse these items in fluids. Care should be taken to prevent
excessive moisture from penetrating transmitter and display housings
VLS 66xx Edge Display
The VLS 66xx Edge display is not waterproof. Do not spray, submerge or
expose display to excessive amount of fluid. The face of the unit,
9
including the front control buttons, is sealed and can be cleaned with
anti-microbial solution wipes. Cleaning of the remainder of the unit
should be done carefully to avoid introducing liquids into the interior of
the monitor.
The above listed cleaning guidelines are intended as suggestions only. They are
based on procedures compatible with specific materials. Disinfection must be
performed to approved hospital protocol. Salter Labs cannot warrant that any of
the recommended methods will guarantee sterility. This must be validated by the
hospital and/or sterilization equipment manufacturer.
Table 1
V. Batteries and Battery Maintenance
The VLS 66xx Edge system is equipped with rechargeable lithium ion
batteries. These batteries are designed to independently provide
optimal power to the monitor and the video blades or wands. The
batteries can be fully recharged many times.
Battery
The 3.7v lithium ion (18650) rechargeable battery in the VLS video
handle powers the monitor, camera, LEDs and lens heating element in
the video blade. It is accessible by removing the cap on the top of the
handle, and can be recharged through the use of a wall charger.
Suggested Battery Protocol:
It is suggested that an additional battery be kept fully charged and
accessible in an independent charger. At shift changes as part of normal
10
protocol the battery power level should be tested by powering up the
VLS 66xx Edge Series unit with a video blade attached; if two yellow
bars are present in the battery icon on the display, it is recommended
that the handle be changed out with a fully charged battery from the
independent battery charger.
• Battery Characteristics: 3.7 volt rechargeable lithium ion, 3400
mAH
• Life of one full charge in continuous use: up to 1.5 hours
(average)
• Time to recharge: approximately 5 hours from fully discharged
state
• Working life: up to 3 years (average)
The 3.7 volt rechargeable handle battery can be continuously installed in
the independent charger for long periods of time. These batteries also do
not exhibit “memory” characteristics, and do not require deep cycle
depletion and recharging regimens to maintain peak functionality.
Note: Allowing rechargeable lithium batteries to fully discharge can damage the
battery and reduce performance significantly. Full discharge of the batteries
should be avoided.
Battery Charging through the Monitor:
The VLS 66xx Edge battery may be more conveniently recharged
through the monitor charger. This is accomplished by plugging the USB
charger into the monitor with the handle and monitor attached, and the
battery installed in the handle as normal.
Circuitry in the monitor will direct current to charge the battery, as
indicated by a RED illumination of the LED on face of the monitor. When
the handle battery is fully charged, the LED will illuminate GREEN.
Internal Time Clock for DVR:
Since the VLS 66xx Edge puts a date and time stamp on each picture or
video, it must maintain the correct time. During periods of non-operation,
this clock will be maintained by a battery within the handle. Once the
handle battery is drained, then the small watch battery within the display
will take over. It is suggested that the handle charge be checked at least
once a week when not in use.
VI. Troubleshooting
Salter Labs VLS systems are generally reliable and simple to operate,
requiring minimal maintenance for extended periods. However, the
following is offered to help deal with unexpected device conditions:
11
1) Monitor is non-functional, shows no sign of power
•Check for proper charging of battery.
•Hold down the On/Off button for 2 seconds before release.
2) Monitor is powered, but shows blue screen
• Ensure that the monitor connector is properly aligned with
and fully inserted in the handle connection point
• Check connection of video blade to handle
• Ensure blade is properly fitted to the handle mount and the
connection is solid
• LEDs on video blade should be fully illuminated
• Verify battery is charged and installed correctly with positive
terminal inserted first/down in handle.
3) Image appears on screen, but is grainy or dim
• Ensure that handle battery is adequately charged
• Check all blade and handle connections
• Ensure that lenses on camera and LEDs on blade are
clean, and not contaminated
4) Unit Turns on but then shuts down
If the display turns on, flashes a blue bar and then displays
“Shutting Down” it is likely that the battery has fallen below the
required voltage to run both the monitor and the VLS blade.
Even though the lights are illuminated on the blade or wand,
exchange the handle battery with a fully charged replacement.
12
IntuBrite VLS Limited Warranty
Salter warrants its IntuBrite VLS Products to be free of defects in
materials and workmanship under normal use and service of the
instruments for twelve (12) months from date of purchase.
What is covered: Replacement of Parts and associated Labor.
What is not covered: Transportation charges to and from Salter
warehouse, damage caused by abuse, misuse, accident or negligence.
To Obtain Warranty Service: Please contact
Customercare@salterlabs.com. The Customer Care representative
will need the part number(s) and serial number(s) of the items for
which repair is being requested under the warranty. The Customer
Care Representative will review the situation, and if appropriate,
issue a Repair Order Number. This Repair Order Number should be
provided with the item(s) being returned for repair.
A Repair Order Number is valid for thirty (30) days after issuance.
Any returns after the thirty (30) day period has expired are not
authorized and will not be accepted.
At the date of original order, you may opt to purchase an Extended
Warranty for IntuBrite VLS Products which extends your warranty
for either one (1) year or three (3) years beyond expiration of the
original one (1) year warranty.
13
Salter Extended Warranty for IntuBrite VLS Products
Salter’s Extended Warranty covers all VLS products against defects in
material and workmanship for a period of up to six (6) years from
date of original purchase. This extended warranty is available only to
the original purchaser of the VLS system or components, and is not
transferable. A one (1) year extended warranty or a three (3) year
extended warranty may be purchased in advance and may also be
extended for up to three (3) additional years after the completion of
the initial Extended Warranty period, accumulating a maximum of six
(6) years of coverage.
If additional equipment is added to the original VLS system, an
extended warranty package can be purchased separately and
independently for each item under the above terms.
If a VLS system fails for any reason during the extended warranty
period, Salter will repair or replace the failed component of the VLS
system. If requested, Salter can provide a loaner unit. The customer
agrees to return the damaged VLS product to IntuBrite upon receipt
of the loaner unit and agrees to return the loaner unit within three
(3) business days after return receipt of the repaired unit.
This extended warranty does not apply to product that has been
damaged due to obvious mishandling or as a result of modification
by an unauthorized repair station or person.
Salter Labs
30 Spur Drive
El Paso, TX 79906 USA
www.salterlabs.com
MT Promedt Consulting GmbH
Altenhofstraße 80
D-66386 St. Ingbert
Germany

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