Acelrx Pharmaceuticals ARX2006 Zalviso hand-held patient controlled analgesia (PCA) system User Manual Manual 4 4

AcelRx Pharmaceuticals Inc. Zalviso hand-held patient controlled analgesia (PCA) system Manual 4 4

Manual 4/4

AcelRx Pharmaceuticals, Inc. –Zalviso™ sufentanil sublingual tablet system 114
Instructions for Use –PL-1678 Rev. K
STEP 4 Disconnect and Clean Controller
1. Squeeze the side release latches on the end
of the Charger to unlock and remove the end
of the Charger from the bottom of the
Controller.
2. Power off the Controller by pressing the
Power Button.
3. Wipe the Controller with alcohol wipes and
allow to dry.
4. Place the Controller in a clean storage bag.
5. Disconnect the Charger from the AC power
outlet.
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Instructions for Use –PL-1678 Rev. K
19. Transferring Patient Use Data
The Data Cable is available for transferring data from the Controller to other electronic media, if
desired. To conduct downloading of the patient use data, which may be performed after a
System Discontinuation for each patient, the Healthcare Professional can access the “Transfer
Data” feature via an AAC or TAB.
NOTE
No patient identification information is recorded in the Controller data. Patient’s
usage history is recorded in the Controller data by date and time of use by the
patient.
STEP 1 Access Transfer Data Screen
System Menu
(AAC)
Utility Menu
(TAB)
1. The Healthcare Professional must turn the
System on by holding down the Power
Button for 3 to 4 seconds.
2. The first screen they will see will ask them
to touch the AAC or TAB to the Blue
Dose Button. This action will present
the System Menu or Utility Menu options.
3. Scroll to the Transfer Data option then
select it by pressing the Enter/Select
Button.
STEP 2 Connect Cable
1. Follow the instructions on-screen.
2. Connect the custom Data Cable to the
Controller’s Charging/Data connector and
Computer’s USB port (the Computer must
be running Windows 7 operating system).
Ensure the Data Cable’s connector snaps
into the Controller’s Charging/Data Port
connector.
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Instructions for Use –PL-1678 Rev. K
STEP 3 Launch PC Application
1. To start or launch the PC application software that transfers the patient use data from the
sufentanil sublingual tablet system, double click on the “Zalviso™(sufentanil tablet
system) Event Log Download Utility” icon on the desktop (present after software
installation). If the Windows Open File -Security Warning window is displayed, select
“Run”.
2.
A similar Download Utility application window should be displayed, as shown above.
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Instructions for Use –PL-1678 Rev. K
STEP 4 Make New Folder or Select Folder on PC
1. The System should display Device
ready to start transfer
2. Using the PC mouse, click on the PC
application’s Download Folder
Location field to activate the “Browse
For Folder” window to display, as shown
at left. Make New Folder according to
the institution’s procedure or select a
folder on the PC to transfer the Patient
Use Data file to. Then click on OK
tablet.
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Instructions for Use –PL-1678 Rev. K
STEP 5 Start Transfer on PC
The PC application’s Download Folder field should display the folder path selected, as shown
below. Using the PC mouse, click on the PC application’s Start Transfer button.
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STEP 6 Await Transfer
The System will display Do NOT Disconnect, Transfer in progress…..
DO NOT disconnect the System during the data transfer. The PC application will display
Downloading event log… and the download status by updating the green status bar.
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STEP 7 Confirm Transfer Complete
1. The System will display Transfer Complete once the Patient Use Data is
successfully downloaded.
2. Disconnect the Data Cable (by squeezing on the sides) from the Controller.
3. The PC application should display a Transfer complete and 100% green status bar once
the Patient Use Data is downloaded successfully. Click on the red “X” on the upper right-
hand corner of the PC application window to close the application.
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Instructions for Use –PL-1678 Rev. K
Did you receive a Transfer Failed error message?
If any error occurs at this point, follow the on screen instructions to disconnect the
Data Cable and try again. Ensure the Data Cable’s connector snaps into the
Controller’s Charging/Data Port.
If this error continues to occur, replace the Data Cable and try again. If the error
continues after replacing the Data Cable, contact the biomedical technician or
contact the manufacturer to arrange for the return of the Controller.
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Instructions for Use –PL-1678 Rev. K
20. Reviewing Former Patient Data
Former patient data can only be accessed using an AAC or TAB before the System has been
setup for the next planned patient. It must be selected from the display screen immediately after
powering on. Former patient data cannot be accessed while in patient use mode. The System
will retain use history for five patients. The System memory follows the “first in first out” principle
for memory allocation,meaning that the first patient’s data is erased as the sixth patient starts to
use the System.
NOTE
No patient identification information is recorded in the Controller data. Patient’s
usage history is recorded in the Controller data by date and time of use by the
patient.
STEP 1 Access Former Patient Data Screen
System Menu (AAC) Utility Menu (TAB)
To view a former patient’s data, select the
patient by their date and time of first dose.
Scroll up or down using the Left or Right
button, then pressing the Enter/Select button
to select the patient. Press the menu button to
return to the previous menu.
STEP 2 View Patient Data Screen
The patient’s first dose date and time is displayed in the header (e.g.
6/03/2013 11:14, shown in display below). The first display of the
patient data initially summarizes the total quantity of tablets and
cumulative doses for the selected patient below the header (e.g. 21
Tablets, 315 mcg taken, shown in display below).
This summary is not displayed after scrolling up or down. However, the
summary can be displayed again by pressing the Enter/Select
button to exit, and then reselect the former patient from the Select
Patient menu.
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Instructions for Use –PL-1678 Rev. K
STEP 3 Browse Patient Data
The former patient’s data history is viewed by scrolling up or down using
the Left or Right button, respectively.
The former patient’s data displays an event time stamp and a
description of the event. A summary of events displayed:
Priming Cap Dispensed
Cartridge unique ID number
Setup Complete
New Pat ID: Patient ID Thumb Tag unique ID scanned at setup
or at Change Thumb Tag
Battery Level: battery level capacity percentage remaining and
battery voltage in millivolts (mV)
Tablet Sense Test Passed (or Failed)
Doses Given: Displayed in green colored text when a dose is
dispensed followed by Patient Thumb Tag ID number in black
colored text
Request in Lockout: Displayed in blue colored text when a dose
was requested during the lockout period
Summary of events (continued):
AAC Access followed by its unique card ID number
Tether Locked/Unlocked
Dispenser Unlatched/Removed
Changed Cartridge: Displayed as Cartridge Changed followed
by its unique ID number
Shift Reset followed by shift’s total tablets
Training Screens Used: Patient training demo selected
Error and error code: Displayed in red text as Error or Assert
and corresponding error code or assert error information
Power Down and Power Up
Tablets Disp: Total quantity of tablets dispensed by patient
when System is discontinued
Discontinue
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Instructions for Use –PL-1678 Rev. K
1. If the Controller goes to sleep when at viewing Former Patient
Data, wake up the Controller by pressing the menu button and
access using the AAC to return the Former Patient Data screen.
2. Press the Enter/Select button to return to the Former Patient
data select menu.
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Instructions for Use –PL-1678 Rev. K
21. Device Information Screen
In the event that it is necessary for the Healthcare Professional to retrieve the sufentanil
sublingual tablet system’s software version or the Controller Serial number, it can be
accomplished by accessing the System Menu and selecting the “Device Information”. When the
System is not in patient use, the biomedical technician can access the Utility Menu using the
Technician Access Badge (TAB) and select “Device Information”.
STEP 1 Access Device Information
System Menu
(AAC)
Utility menu (TAB)
1. Access the System Menu via the AAC
or access the Utility Menu via the TAB.
2. The first screen they will see will ask
them to touch their AAC or TAB to the
Blue Dose Button. This action will
present the Menu options.
3. Scroll to the Device Information
option in the System Menu or Utility
Menu then select it by pressing the
Enter/Select Button.
STEP 2 View Device Information
The sufentanil sublingual tablet system’s software version and the
Controller serial number are displayed.
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Instructions for Use –PL-1678 Rev. K
22. Troubleshooting
WARNING
System components are not serviceable. Tampering, modifying or opening of
the System or its components may lead to hazardous conditions.
DO NOT attempt to service the Controller. Opening a System component to
attempt troubleshooting or repair will void the manufacturer’s warranty.
NOTE
If any problems are encountered or questions arise during troubleshooting,
please call: 1-855-ZALVISO (1-855-925-8476) for assistance. Refer to Section
16 for more information related to System Notifications, Alerts/Errors and
Alarms.
NOTE
If the Controller displays a message “Error System Cannot Be Used”, along with
a 3 or 4 digit error cod , please call: 1-855-ZALVISO (1-855-925-8476) for
assistance. Depending on the error code and other system details provided to
the Call Center, the Controller may be acceptable to return to service after
reprocessing/recharging, or may need to be returned to the manufacturer.
22.1. Patient Cannot Dose, but System Appears Normal
Check to see that the green light is illuminated indicating that dosing is available.
Check basic Dose History screen to see if patient has been receiving doses. Refer to Section 11,
Basic Dose History and Detailed History.
Check to see that the patient is dosing in an upright orientation. Refer to Section 7, Patient Use.
While the System’s dose available green light is illuminated and the System is in an upright
orientation, have the patient place his thumb with the Thumb Tag on the Dose Button and
observe if Dose Button light flashes. Refer to Section 7, Patient Use.
If the patient’s System orientation during the dose attempt is appropriate and the Dose Button
does not flash green, replace the Patient ID Thumb Tag. Refer to Section 8, Replacing the
Patient ID Thumb Tag).
oIf replacing the patient’s Thumb Tag still does not result in the System permitting the
patient to dose, Discontinue the System and set the patient up with a replacement
System.
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22.2. Patient Cannot Dose, System Appears Unresponsive
Press Enter/Select button to see if screen will wake-up.
Check to see that the green or blue dosing indicator light is illuminated indicating that the System
is on.
If the System does not wake-up, or a dose light is not on, remove the System from the patient,
and set up the patient with a replacement System.
22.3. Cartridge is not Recognized during Setup or Replacing Cartridge
(Receive “No Cartridge” Notification)
Ensure that a Cartridge has indeed been inserted by removing the Dispenser.
Re-insert Dispenser with Cartridge loaded.
If the same notification appears, remove Dispenser and replace the Cartridge with a new one.
22.4. Authorized Access Card (AAC) or Technician Access Badge (TAB) is
not Recognized by System
Ensure that the Display is requesting to “Touch access card” for menu.
Ensure that the AAC or TAB access card is being touched to the large Blue Dose Button on the
back of the Controller and that roughly the middle of the access card is over the Dose Button.
If the System still doesn’t recognize the AAC or TAB, retry with a different AAC or TAB and set
malfunctioning AAC or TAB aside.
NOTE
If any error or problem results in the System, AAC or TAB being replaced,
please notify the biomedical technician.
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Instructions for Use –PL-1678 Rev. K
22.5. During Change Cartridge or Initial Set Up, the Priming Cap is not
observed as being ejected from the System
1. If you did not see the green Priming Cap eject, examine the Dispenser Tip and the
surrounding area. If you find the green Priming Cap in the Dispenser Tip remove it and
select YES.
2. If you find it in the surrounding area select YES.
3. Select NO (Right Button) if the green Priming Cap failed to eject and then follow the
screen instructions to exit setup and discontinue the System.
4. Start over with a new Controller, Dispenser and Cartridge.
WARNING
The Priming Cap is not for patient use, should not be ingested and should be
discarded.
22.6. System Does Not Power On
Check that the Controller is charged. Refer to Section 18, Recharging the Controller.
Press and hold the Controller’s Power Button for at least 5 seconds until the power on tone
and display turns on.
If the Controller powers on, then powers off and is followed by 3 audible beeps and the Controller
powersdown, this indicates the Controller has failed Power-On Self-Test. If this occurs, notify the
biomedical technician.
22.7. System screen is on but System appears unresponsive
Check to see if pressing the Menu button causes the Display to request to “Touch access card”
for menu.
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Instructions for Use –PL-1678 Rev. K
If the System is unresponsive to accessing the Menu, contact Biomedical Engineering to arrange
for removal of the System from the patient’s room.
Place the System away from the patient until it is removed.
22.8. Controller cannot be powered off when not in Patient Use
If the Controller is displaying the Touch access card screen or upon waking up, displays the
Touch access card screen, scan the AAC to display the System menu.
Press and hold the Power Button for about 5 seconds until the Controller powers off.
If the Controller is unresponsive to accessing the System menu or does not power off after
pressing the Power Button for 5 seconds, contact Biomedical Engineering for removal.
22.9. Dispenser cannot be removed after System is Discontinued
Power on the Controller by pressing on the Power Button for about 5 seconds.
A System Error should be displayed. Proceed to System Discontinue.
Retry removing the Dispenser.
If Dispenser cannot be removed,contact Biomedical Engineering for removal.
22.10.Controller powers on then powers off
If during Controller power on, 3 audible beeps are generated then the Controller powers off, this
indicates the Controller has failed the Power-On Self-Test.
Contact Biomedical Engineering for removal of the Controller.
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Instructions for Use –PL-1678 Rev. K
23. General Information
23.1. System Information
Manufacturing and System Use
Manufacturer: AcelRx Pharmaceuticals
Address: 351 Galveston Drive, Redwood City, California USA 94063
Phone: 855-ZALVISO (855-925-8476)
Model: Zalviso Sufentanil Sublingual Tablet System
Classification: Class II equipment, Type BF applied part
Operating Conditions: 15°C to 40°C, 20% to 75% relative humidity
System Use Period: Once set up for patient use, each System can be used for a
maximum of 72 hours per patient. System notifications are generatedwhen the 72-hour
limit is approaching and when 72-hour limit is reached (refer to Section 16, Notifications,
Alerts, Alarms and Errors). If additional therapy is required past 72 hours, a new System
has to be set up for the patient.
System Use Life: Each Controller has a minimum use life of 30,000 doses.
Certifications
The Zalviso sufentanil sublingual tablet system complies with the applicable
requirements of IEC 60601-1: 2012 and its applicable collateral standards
The Zalviso sufentanil sublingual tabletsystem complies with the applicable
requirements of FCC Part 15 subpart C (15.225)
System Power Source
Rechargeable Li-Ion battery, 3.6Vdc, 0.5A peak, 2900mAh
Not serviceable
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Charger:
Input: 100-240VAC, 50-60Hz, single phase, nominal input current 0.15Amps @
max load
Output: 5V DC ±5%, 0.6A
Approved for Medical application. Charger is compliant to the applicable
requirements of IEC 60601-1, ES 60601-1 and EN 60601-1
Charger’s Cord length: 1.8m (72 inches)
Interfaces:
Display: 1.8-inch LCD,176 x 220, TFT, color, white backlight
Indicators: Green and blue indicators, Dose Available and No Dose Available
indicators, respectively
Data port: RS-232 (transmit and receive only)
Audio notification tones, alerts and high priority alarm: Internal audio speaker
RFID and RFID tags: 13.56 MHz, ISO 15693
Alarm:
One high priority alarm, refer to section 16.3
Sound pressure level (SPL) range at the operator’s position (0.3m (1-foot)):
50dB(A) to 60dB(A)
Radiated Emissions Information
Operating Frequency: single frequency, 13.56MHz
Number of Channels: One
Type of Modulation: OOK modulation
Field strength: 36.9 dB(uV/m) at 30 meters
Antenna Type: Multi-turn electrical small loop
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Electromagnetic Compatibility
Table 1 –Guidance and Manufacturer’s Declaration –Electromagnetic Emissions
All ME Equipment and ME Systems
Guidance and manufacturer’s declaration –electromagnetic emissions
The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1 The Zalviso sufentanil sublingual tablet system
uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A The Zalviso sufentanil sublingual tablet system is
suitable for use in all establishments other than
domestic and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
Flicker emissions
Complies
Table 2 –Guidance and Manufacturer’s Declaration –Electromagnetic Immunity
All ME Equipment and ME Systems
Guidance and manufacturer’s declaration
electromagnetic immunity
The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure
that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
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Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Voltage Dips 30%
reduction, 25/30
periods
At 0°
Voltage Dips 30%
reduction, 25/30
periods
At 0°
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
Zalviso sufentanil sublingual tablet
system requires continued
operation during power mains
interruptions, it is recommended
that the Zalviso sufentanil
sublingual tablet system be
powered from an uninterruptible
power supply or a battery.
Voltage Dips > 95%
reduction, 0.5 period
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
Voltage Dips > 95%
reduction, 0.5 period
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
Voltage Dips > 95%
reduction, 1 period
At 0°
Voltage Dips > 95%
reduction, 1 period
At 0°
Voltage Interruptions >
95% reduction,
250/300 periods
Voltage Interruptions >
95% reduction,
250/300 periods
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m Power frequency magnetic fields
should be at levels characteristic of
atypical location in a typical
commercial or hospital
environment.
Caution: Be Cautious
Near MRI and X-ray
Equipment
Keep the Zalviso sufentanil sublingual tablet system away
from MRI and X-ray equipment. Strong magnetic fields
(those beyond the levels tested) may cause the device to
operate improperly.
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Table 3 – Guidance and Manufacturer’s Declaration –Electromagnetic Immunity
ME Equipment and ME Systems that are NOT Life-supporting
Guidance and manufacturer’s declaration –electromagnetic immunity
The Zalviso sufentanil sublingual tablet system is intended for use in the electromagnetic environment
specified below. The customer or the user of the Zalviso sufentanil sublingual tablet system should assure
that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment –
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
(6 Vrms in ISM radio
Bands within 150kHz
–80MHz)
3 V/m
80 MHz to 2.7 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Zalviso sufentanil sublingual
tablet system, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.2P
d = 1.2P 80 MHz to 800 MHz
d = 2.3P 800 MHz to 2.7 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency range.b
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
Zalviso sufentanil sublingual tablet system is used exceeds the applicable RF compliance level above, the
Zalviso sufentanil sublingual tablet system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the
Zalviso sufentanil sublingual tablet system.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Table 4 – Recommended Separation Distances between portable and mobile RF Communications
equipment and the Zalviso sufentanil sublingual tablet system
ME Equipment and ME Systems that are NOT Life-supporting
Recommended separation distances between portable and mobile RF communications equipment
and the Zalviso sufentanil sublingual tablet system
The Zalviso sufentanil sublingual tablet system is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the Zalviso sufentanil
sublingual tablet system can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Zalviso sufentanil
sublingual tablet system as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2P
80 MHz to 800 MHz
d = 1.2P
800 MHz to 2.7 GHz
d = 2.3P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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Table 5 – Immunity to RF Wireless Communications Equipment
Immunity to RF Wireless Communications Equipment
Test
Frequency
(MHz)
Band a)
(MHz)
Service a) Modulation b)
Maximum
Power
(W)
Distance
(m)
IMMUNITY
TEST
LEVEL
(V/m)
385 380 –390 TETRA 400
Pulse
modulation b)
18 Hz
1.8 0.3 27
450 430 –470 GMRS 460,
FRS 460
FM
± 5 kHz
deviation
1 kHz sine
20.3 28
710
704 –787 LTE Band 13,
17
Pulse
modulation b)
217 Hz
0.2 0.3 9745
780
810
800 –960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
20.3 28
870
930
1720
1700 –1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
20.3 28
1845
1970
2450 2400 –2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
20.3 28
5240
5100 –5800 WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0.2 0.3 95500
5785
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
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FCC Compliance Statements
This device is certified under FCC ID: 2AA4P-ARX2006
Part 15.19
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Part 15.105
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This device generates uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation.
Part 15.21
Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
23.2. Inspect Packaging and Components
Make sure to inspect the packaging and components as follows:
Inspect all shipping packages and individual packages for damage.
Remove the primary packages from the shipping boxes. DO NOT remove components
from their primary boxes or primary plastic bags until ready for use.
WARNING
DO NOT remove Cartridges from pouches until ready for use.
23.3. Storage and Handling
All components should be stored at room temperature in a secure location per institutional
guidelines.
Access should be limited to authorized users.
Drug Cartridges contain a Controlled Substance (CII Opioid) and should be stored in an
appropriate secure location at controlled room temperature (15 -30°C).
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24. Use of Cartridge Label RFID Reader
The Cartridge Label RFID Reader enables the Healthcare Professional to read and display the
number of remaining tabletsin used Cartridges, as electronically recorded on the Cartridge RFID
Label. If necessary, the Cartridge Label RFID Reader can also be used to display the Cartridge’s
detailed information,such as drug name, dosage strength and Drug Cartridge’s unique RFID
number. To read the RFID information on the Cartridge Label,refer to the instructions in this
section.
To use the Cartridge Label RFID Reader to display the “tabletsremaining”recorded on the
Cartridge RFID Label:
STEP 1 Connect to PC
1. Connect the Cartridge Label RFID Reader to a
computer’s (PC) USB port. The RFID Reader’s
indicator should illuminate indicating power and
connection to the USB port.
2. If not already completed, install the Cartridge
Label RFID Reader application software that
was provided with the Cartridge Label RFID
Reader.
STEP 2 Launch PC Software
1. Execute the Cartridge Label RFID
Reader application software.
2. The following screen appears on the
computer screen, with “Place the
Zalviso™Cartridge onto the
Cartridge RFID Reader”.
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STEP 3 Introduce Drug Cartridge to RFID Reader
Place the used Drug Cartridge onto the Cartridge Label RFID Reader.
STEP 4 View “Tablets Remaining” as recorded on Cartridge Label RFID
1. The number of tablets remaining, as recorded on the Cartridge RFID Label, is displayed
on the Cartridge Label RFID Reader application. The sample screen above displays the
RFID scan status from a detected Cartridge RFID Label and indicates 14 tablets
remaining read from the Cartridge RFID Label.
2. If desired, print the information presented on the Cartridge Label RFID Reader
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application screen by clicking the “Print” button located on the upper right of the
application screen.
WARNING
If it appears that the “tablets remaining”as recorded on the Cartridge
Label RFID is different than the number of tablets ACTUALLY
REMAINING in the Cartridge, diversion may have occurred. See Section
14.2 for manual tablet accounting & reconciliation.
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25. Biomedical Technician Utility Menu
When not in patient use, the biomedical technician can use a Technician Access Badge (TAB) to
access the Controller’s utility features consisting of:
Diagnostics (Refer to Section 26)
Transfer Data (refer to Section 19)
Power Down (Refer to Section 27)
Set Time and Date (Refer to Section 28)
Former Patient Data (Refer to Section 20)
Device Information (Refer to Section 21)
Use Life (Refer to Section 29)
The utility menu is accessible by the biomedical technician with the use of a Technician Access
Badge (TAB).
The user will use the TAB to gain access to the System Controller’s technician utility
menu.
The System Controller prompts the user to touch the gray circle of the TAB access card
to the blue Dose Button located on the back of the Controller.
The TAB does not allow the user to setup the System for its intended use.
When the System is in patient use, menu access via the TAB is not allowed by the
System.
The TAB should not be exposed to X-rays, MRI, or other strong electromagnetic fields.
NOTE
If any problems are encountered or questions arise during use of the Biomedical
Technician Utility Menu, diagnostics or troubleshooting, or if an Error has
occurred, please call: 1-855-ZALVISO (1-855-925-8476) for assistance.
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25.1. Accessing the Technician Utility Menu
STEP 1 Power-On Device
Turn on the Controller by pressing and holding the
Power button for approximately 3 to 5 seconds until
the System turns on. The AcelRx startup screen will
appear. Ensure that the Controller’s battery is fully
charged. Refer to Section 18, Recharging the
Controller.
If the AcelRx startup screen is not displayed and is
followed by a 3 audible beeps or if the Controller
powers off after the AcelRx startup screen appears,
then followed by the display turning off and followed by
a 3 audible beeps, this indicates the Controller has
failed Power-On Self-Test. If Power-On Self-Test fails,
proceed to the “What To Do If a Diagnostics Test or
Power-On Self-Test Fails” section instructions
described later in this section.
STEP 2 Touch Access Card to Controller
1. The screen will prompt you to touch the circle
of the Access Card to the blue Dose Button on
the BACK of the Controller.
2. Touch the gray circle of the TAB access card
to the Blue Dose button on the Controller.
The System will announce a tone to confirm
that the System has successfully read the
card.
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STEP 3 View Utility Menu
The Utility Menu will be displayed on the Controller
screen on the front of the Controller.
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26. Diagnostics
The Utility menu “Diagnostics”feature provides capabilities for the biomedical technician to check
the Controller’s functions if there is an operational issue during normal System use by the nurse
or patient.
26.1. Accessing the Diagnostics Screen
STEP 1 Navigate to the Diagnostics Screen
1. To access the Diagnostics menu from the Utility menu, scroll to
Diagnostics then press the Enter/Select button.
2. The Diagnostics Menu will be displayed on the Controller
screen on the front of the Controller.
STEP 2 View the Diagnostics Screen
The Diagnostics Menu displays a list of functional tests:
Tether motor test
LED indicators
Dispense motor test
Sound test
RFID check
Accelerometer test
Buttons
When in the Diagnostics Menu, select a functional test by using the
Left/Right button to scroll to a functional test until highlighted in bold
then press the Enter/Select button.To return to the Utility Menu
from the Diagnostics Menu, press the Menu button.
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26.2. Diagnostic Test Descriptions
NOTE
If any of the following diagnostic tests fail or do not operate as indicated please
proceed to the “What To Do If a Diagnostics Test or Power-On Self-Test
Fails” instructions described later in this section.
TETHER MOTOR TEST
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Runs the Controller’s tether
motor to Tether latch
position then returns to
Tether unlatch position.
Do not install a Tether into
the Controller during the
Tether motor test.
Verify the Controller’s Tether
motor sound and feel as the
motor runs to the Tether latch
and Tether unlatch positions.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
The Controller is
defective if theTether
Motor Test fails.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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LED INDICATORS
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Lights and flashes the
Controller’s Dose Available,
No Dose Available and
Blue Dose Button
indicators in sequence.
After pressing the
Enter/Select button, look
at the indicators on the back
side of the Controller. Verify
the Controller’s Dose
Available, No Dose Available
and Blue Dose Button
indicators light and flashes.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
If the technician verifies
the Controller’s LED
indicators do not light and
flash, then the LED
Indicators Test has failed.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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DISPENSE MOTOR TEST
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Runs the Controller’s
dispense motor to the
Dispenser latch position
then returns to Dispenser
unlatch position.
DO NOT install a Dispenser
into the Controller during
the Dispenser motor test.
Verify the Controller’s
dispense motor sound and
feel as the motor runs to the
Dispenser latch to Dispenser
unlatch positions.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
The Controller is
defective if the Dispense
Motor Test fails.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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SOUND TEST
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Generates the Controller’s
six audible tones in
sequence.
Verify six audible tones are
generated in sequence (i.e.
Power On, Power Down,
Confirmation, Negative, Low
Level Alert and Dose tones).
Press on the Enter/Select
button to return to the
Diagnostics Menu.
If the technician verifies
the Controller does not
generate all six audible
tones, then the Sound
Test has failed.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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RFID CHECK
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Scans for a System secure
access component such as
the AAC, TAB and Patient
ID Thumb Tag.
When Scan an ID is
displayed, technician places
System secure access
component against the
Controller’s Blue Dose
Button.
Verify the System secure
access component (i.e. AAC,
TAB or Patient ID Thumb
Tag) is found and displayed
when placed against the
Controller’s Blue Dose
Button.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
If the technician verifies
the Controller does not
detect and display the
secure access
component against the
Controller’s Blue Dose
Button (i.e. AAC, TAB
or Patient ID Thumb
Tag), then the RFID
Check has failed.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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ACCELEROMETER TEST
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Checks the Controller’s
orientation accelerometer is
functional.
Accelerometer test displays
an orientation circle. When
the Controller is in the
proper dosing position (i.e.
upright) the orientation cicle
should be green.
When the Controller’s in the
improper dosing position
(i.e. sideways) the
orientation cicle should be
blue.
Technician starts with the
Controller’s orientation in the
upright position and verify the
orientation cicle is green.
Rotate the Controller in a
circular motion through
various orientations and
verify the orientation cicle
changes from green to blue
then back to green.
Verifying the orientation circle
color while rotating the
Controller 360° in the vertical
axis is one method to check
the accelerometer
functionality.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
If the technician verifies
one of the following:
The orientation circle
does not change to green
when the Controller is an
upright position.
When the Controller is
rotated 360° in the
vertical axis the
orientation circle does not
change color.
Then the Accelerometer
Test has failed.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer. Refer to
Section 23, General
Information, for the
manufacturer’s contact
information.
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BUTTONS TEST
Diagnostic Test Functional Test
Description
Technician Functional
Check
If Functional Check
Fails
Checks the Controller’s
buttons are functional.
When the Push a button
is displayed, press one of
the Controller’s Menu
button, Power button,
Left button, Right button,
Blue Dose Button or
the Enter/Select
(Center) button.
While pressing the
Controller’s Menu button,
Power button, Left button,
Right button, Blue Dose
Button or the
Enter/Select button, verify
the corresponding button
name is displayed.
Press on the Enter/Select
button to return to the
Diagnostics Menu.
If the technician verifies a
Controller’s button is not
detected when pressed,
then the Buttons Test has
failed.
Contact the manufacturer
to arrange the return of
the Controller to the
manufacturer.
Refer to Section 23,
General Information, for
the manufacturer’s
contact information.
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What To Do If a Diagnostics Test or Power-On Self-Test Fails
If during Controller power on, 3 audible beeps are generated then the Controller powers off, this
indicates the Controller has failed the Power-On Self-Test.
If the biomedical technician verifies that a Controller repeatedly has a System Error, fails
Diagnostics or fails Power-On Self-Test, contact the manufacturer to arrange the return of the
Controller to the manufacturer. Refer to Section 23, General Information, for the manufacturer’s
contact information.
WARNING
System components are not serviceable. Tampering, modifying or opening of
the System or its components may lead to a hazardous condition, and will void
the manufacturer’s warranty.
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27. Power Down from Utility Menu
The Utility menu “Power Down”feature provides capabilities for the biomedical technician to
power off the Controller.
Power Down
To power off the Controller from the Utility menu, scroll to Power Down
then press the Enter/Select button.
The Controller’s display and indicators should turn off, and the power
down tone should be audible during power down.
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28. Set Time and Date
The Utility menu “Set Time and Date”feature provides capabilities for the biomedical technician
to set the Controller’s time and date when not in normal use.
Setting the Controller’s 24-hour format time and date should be performed by the biomedical
technician:
Upon receipt of Controller from the manufacturer,
Upon applicable annual standard and daylight time changes, or
When Controller’s displayed time and/or date does not correspond to the institution’s
time and/or date
STEP 1 Navigate to Time & Date Screen
1. To set the Controller’s time and date from the Utility menu, scroll
to Set Time & Date then press the Enter/Select button.
STEP 2 Set Hours & Minutes
1. The Controller’s time is displayed in a 24-hour format. An
example of 24-hour time format compared to 12-hour time format
is shown in the table below. To set the Controller’s hour, use the
right and left buttons to set the hour value. Then press the
Enter/Select button.
12 Hour Time Format 24 hour Time Format
12:30 AM 00:30
4:14 AM 04:14
7:45 PM 19:45
11:59 PM 23:59
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2. To set the Controller’s minutes, use the right and left buttons to
set the minute value. Then press the Enter/Select button.
STEP 3 Set Year, Month & Day
1. To set the Controller’s year, use the right and left buttons to set
the year. Then press the Enter/Select button.
2. To set the Controller’s month, use the right and left buttons to set
the month value. Then press the Enter/Select button.
3. To set the Controller’s day, use the right and left buttons to set
the day value. Then press the Enter/Select button.
4. Press the Enter/Select button to return to the Utility menu.
NOTE
If an error was made in setting any of the values, access the Utility Menu and
select Set Time and Date and start over.
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29. Use Life
The Utility menu “Use Life”feature provides capabilities for the biomedical technician to display
the cumulative dose count and total doses remaining until end of use life of the sufentanil
sublingual tablet system Controller. A total count of 30,000 doses dispensed is the end of use life
limit of the Controller. The Controller software will not allow the System to be set up for a new
patient if the end of use life could possibly be reached during patient use, i.e., the end of use life
of 30,000 doses could be reached in 3 cartridges of 40 tablets each. At the end of use life, the
Controller should be disposed of according to hospital procedures for battery and electronic
waste.
Refer to “End of Use Life Approaching” and “End of Use Life Reached” notifications in Section
16.1.
STEP 1 Navigate to Use Life Screen
To view the Use Life from the Utility menu, scroll to Use Life then press
the Enter/Select button.
STEP 2 View Use Life
1. The Use Life screen displays the use life of the sufentanil
sublingual tablet system. The example Use Life display
indicates the sufentanil sublingual tablet system has 13,000
doses given and 17,000 doses remaining until end of use life of
the Controller is reached.
2. Press the Enter/Select button to return to the Utility menu.
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ATTACHMENT 1:
Patient Reference Sheet
PL-1752 Rev. E
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Patient Reference Sheet
Zalviso™ (sufentanil sublingual tablet system)
Take a dose when needed for pain relief or before an activity that may increase your pain.
For your safety, the System will make you wait at least 20 minutes between doses.
DO NOT share this medication. DO NOT dispense tablets into your hand and take them later.
DO NOT take into the shower or submerge in liquid. Call a nurse if you spill liquid on the System.
When can I take a dose?
Dose Available
(Green Light)
You may take a dose
if needed.
Dose Unavailable
(Blue Light)
You cannot take a dose.
How do I take my dose?
Remove the Cap and hold the System in your hand that
has the Patient ID Thumb Tag.
Do not touch or press the Blue Dose Button with your
thumb until the Dispenser tip is under the tongue.
Keep the System relatively upright to dose.
First place the Dispenser tip UNDER your tongue and
THEN press the Dose Button with your thumb.
Do not apply downward pressure on the Dispenser tip when
dosing.
Keep the Dispenser tip under your tongue until you hear the
dosing tone and feel the motor vibration stop.
Store the System in its Holster in between doses to
minimize the chance of inadvertent dispensing of a
tablet.
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DO NOT chew or swallow the tablet.
DO NOT eat or drink and minimize talking for 10
minutes after taking a dose.
Call the nurse if the System is continuously beeping
and flashing between doses.
Call the nurse if you have any trouble taking a dose or
keeping the tablet under your tongue.
Call the nurse if you accidentally dispense a tablet
when you are not taking a dose, or if you see one or
more loose tablets.
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Signature Manifest
Document Number: PL-1678 Revision: K
Title: PL-1678 ZALVISO sufentanil sublingual tablet system - Instructions For Use
All dates and times are in Pacific Standard Time.
PL-1678 Rev J to K Zalviso IFU
Change Request
Name/Signature Title Date Meaning/Reason
David Freed (DFREED) Executive Director, Quality
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality
Kathy Wilson (KWILSON) Sr. Manager, Document Control 14 Jan 2019, 12:45:26 PM Approved
Collaboration
Name/Signature Title Date Meaning/Reason
Tammy Le (TLE) Manager, Quality
Brandon Pe (BPE) Manufacturing Buyer/Planner
Anil Dasu (ADASU) CHIEF ENGINEERING OFFICER
Bill Callahan (BCALLAHAN) Sr. Director Manufacturing Ops
Casidy Domingo (CDOMINGO) Director, Engineering In Process
David Freed (DFREED) Executive Director, Quality
Kimberly Gaumer (KGAUMER) VP Regulatory & Quality Assura
Lana Chin (LCHIN) Assoc Dir Regulatory Affairs
Noel Singh (NSINGH) Director, Supply Chain
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality In Process
Angie Griffin (AGRIFFIN) Sr Director Project Management
Majella Dooley (MDOOLEY) SENIOR DIRECTOR
REGULATORY AFF 16 Jan 2019, 11:30:11 AM Complete
Mark Curtiss (MCURTISS) Senior Manager, Quality 18 Jan 2019, 11:49:54 AM Complete
Samir Shah (SSHAH) Manager, Product Manufacturing 04 Feb 2019, 09:48:42 AM Complete
Al Landas (ALANDAS) Director, Elect., Software Eng 04 Feb 2019, 03:41:51 PM Complete
Kathy Wilson (KWILSON) Sr. Manager, Document Control 05 Feb 2019, 11:06:02 AM Complete
ENG-MGR Approval
Name/Signature Title Date Meaning/Reason
Bill Callahan (BCALLAHAN) Sr. Director Manufacturing Ops
Casidy Domingo (CDOMINGO) Director, Engineering
Noel Singh (NSINGH) Director, Supply Chain
Angie Griffin (AGRIFFIN) Sr Director Project Management
Brandon Pe (BPE) Manufacturing Buyer/Planner
Samir Shah (SSHAH) Manager, Product Manufacturing
Anil Dasu (ADASU) CHIEF ENGINEERING OFFICER 13 Feb 2019, 12:48:19 PM Approved
QA-MGR Approval
Name/Signature Title Date Meaning/Reason
Printed on: ; Printed by: .
Tammy Le (TLE)
Manager, Quality
David Freed (DFREED) Executive Director, Quality
Kimberly Gaumer (KGAUMER) VP Regulatory & Quality Assura
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality
Mark Curtiss (MCURTISS) Senior Manager, Quality 06 Feb 2019, 09:22:22 AM Approved
Originator Approval
Name/Signature Title Date Meaning/Reason
Al Landas (ALANDAS) Director, Elect., Software Eng 05 Feb 2019, 11:18:23 AM Approved
DOC-MGR Approval
Name/Signature Title Date Meaning/Reason
David Freed (DFREED) Executive Director, Quality
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality
Kathy Wilson (KWILSON) Sr. Manager, Document Control 05 Feb 2019, 11:06:28 AM Approved
REG-MGR Approval
Name/Signature Title Date Meaning/Reason
Kimberly Gaumer (KGAUMER) VP Regulatory & Quality Assura
Lana Chin (LCHIN) Assoc Dir Regulatory Affairs
Majella Dooley (MDOOLEY) SENIOR DIRECTOR
REGULATORY AFF 05 Feb 2019, 08:14:20 PM Approved
Doc Control Set Date Collaboration Step
Name/Signature Title Date Meaning/Reason
David Freed (DFREED) Executive Director, Quality
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality
Kathy Wilson (KWILSON) Sr. Manager, Document Control 13 Feb 2019, 01:51:57 PM Complete
DOC-MGR Final Approval
Name/Signature Title Date Meaning/Reason
David Freed (DFREED) Executive Director, Quality
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality
Kathy Wilson (KWILSON) Sr. Manager, Document Control 13 Feb 2019, 01:52:23 PM Approved
Notify
Name/Signature Title Date Meaning/Reason
Tammy Le (TLE) Manager, Quality 13 Feb 2019, 01:52:24 PM Email Sent
Brandon Pe (BPE) Manufacturing Buyer/Planner 13 Feb 2019, 01:52:24 PM Email Sent
Samir Shah (SSHAH) Manager, Product Manufacturing 13 Feb 2019, 01:52:24 PM Email Sent
Anil Dasu (ADASU) CHIEF ENGINEERING OFFICER 13 Feb 2019, 01:52:24 PM Email Sent
Angie Fuentes (AFUENTES) Material's Testing Logistics 13 Feb 2019, 01:52:24 PM Email Sent
Al Landas (ALANDAS) Director, Elect., Software Eng 13 Feb 2019, 01:52:24 PM Email Sent
Bill Callahan (BCALLAHAN) Sr. Director Manufacturing Ops 13 Feb 2019, 01:52:24 PM Email Sent
Ben Yaffe (BYAFFE) CONTRACTOR, ENGINEERING 13 Feb 2019, 01:52:24 PM Email Sent
Casidy Domingo (CDOMINGO) Director, Engineering 13 Feb 2019, 01:52:24 PM Email Sent
David Freed (DFREED) Executive Director, Quality 13 Feb 2019, 01:52:24 PM Email Sent
Printed on: ; Printed by: .
Kimberly Gaumer (KGAUMER)
VP Regulatory & Quality Assura
13 Feb 2019, 01:52:24 PM
Email Sent
Kathy Wilson (KWILSON) Sr. Manager, Document Control 13 Feb 2019, 01:52:24 PM Email Sent
Lana Chin (LCHIN) Assoc Dir Regulatory Affairs 13 Feb 2019, 01:52:24 PM Email Sent
Mark Curtiss (MCURTISS) Senior Manager, Quality 13 Feb 2019, 01:52:24 PM Email Sent
Majella Dooley (MDOOLEY) SENIOR DIRECTOR
REGULATORY AFF 13 Feb 2019, 01:52:24 PM Email Sent
Noel Singh (NSINGH) Director, Supply Chain 13 Feb 2019, 01:52:24 PM Email Sent
Sundaravel Ananthavel
(SANANTHAVEL) Director, Quality 13 Feb 2019, 01:52:24 PM Email Sent
Angie Griffin (AGRIFFIN) Sr Director Project Management 13 Feb 2019, 01:52:24 PM Email Sent
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Name/Signature Title Date Meaning/Reason
Kathy Wilson (KWILSON) Sr. Manager, Document Control 15 Feb 2019, 03:01:12 PM Approved
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