TwitchView IFU
TwitchView IFU
TWITCHVIEW SYSTEM
OPERATING MANUAL
Intended Use
The TwitchView System is used for the quantitative monitoring of
neuromuscular transmission by means of electromyography (EMG).
Caution
Federal law restricts this device to use by or on the order of a physician.
MONITOR
The TwitchView Monitor stimulates a peripheral nerve and measures
the resulting electromyographic (EMG) response. The user interacts with
the TwitchView Monitor via a touchscreen LCD and a Power button. The
TwitchView Monitor includes a cable to connect the Electrode Array to the
Monitor. When the Monitor is docked in the Charging Station, the Monitor’s
lithium ion battery is charged inductively, and the Monitor transmits
neuromuscular monitoring data to the Charging Station by means of an
infrared communications port.
CHARGING STATION
The Charging Station charges the Monitor and outputs
neuromuscular monitoring data from the Monitor via an RJ45
connector. The Charging Station plugs into a standard wall
outlet and includes hardware for mounting to a pole or other
piece of equipment.
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TWITCHVIEW SYSTEM COMPONENTS
ELECTRODE ARRAY
The single-patient use Electrode Arrays contain five independent electrodes— two for nerve stimulation and three
for EMG. The Arrays have been designed to work on either the left or right hand. Use the Array size that best fits
the patient’s hand.
LARGE ADULTS
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PATIENT MONITORING
1 Remove the release liner from the Stimulation portion of the Electrode Array and position the
two stimulation electrodes over the ulnar nerve at the patient’s wrist. Preparing the skin with
an alcohol wipe or mild skin abrasion will improve signal quality. Placement over dense hair or
scars should be avoided.
LARGE
ulnar groove
2 Remove the release liner from the EMG portion of the Electrode Array. For the large array, secure electrode 1
or 2 over the adductor pollicis, with the other electrode over the first dorsal interosseous muscle. The ground
electrode (G) should be secured to the patient’s index finger. For the medium/small arrays, secure electrode 1 and
2 over the adductor pollicis and the ground electrode (G) to the index finger.
RIGHT HAND
LARGE MEDIUM/SMALL
LEFT HAND
LARGE MEDIUM/SMALL
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PATIENT MONITORING
3 Insert the Electrode Array Tab into the Monitor Cable. Use tape to secure the array/cable
connection to the patient’s arm.
4 Touch anywhere on the Monitor screen to wake up the device and then press the Start button.
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PATIENT MONITORING
5 The system automatically selects the optimal EMG recording electrode and determines the
supramaximal stimulation current. If the patient is already paralyzed, automated electrode
selection and/or supramaximal current determination may not be possible, in which case the
system uses default values.
response
height
E1 E2 current (mA)
CANCEL CANCEL OK
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PATIENT MONITORING
6 The system begins Train-of-Four (TOF) monitoring. The user can toggle between a time plot (left panel
below) and the EMG signal (right panel) by touching the screen over the smaller plot (lower left corner of
screen). The stimulating current can be adjusted by touching the blue current icon, whereas the repeat
frequency of the TOF sequence can be adjusted by touching the orange Set Repeat timer.
1hr
30%
2hr
8hr
Note: If the supramaximal stimulating current has been determined, the height of the calibration pulse
will be displayed in blue to the left of the train-of-four bars.
Note: If the signal quality is too poor to accurately determine a TOF count or a TOF ratio (e.g. due to
excessive electrocautery noise or extreme physical motion), the screen will display “Excessive Noise.”
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PATIENT MONITORING
7 Auto PTC causes the system to switch between train-of-four stimulation and post-tetanic count (PTC)
stimulation depending on the patient’s degree of neuromuscular block. When enabled, if the TOF count
decreases to zero during ongoing TOF monitoring, the user will be prompted to switch to PTC to monitor
deep blockade.
1hr
30%
2hrs
8hrs
60 mA 00:10
If selected, PTC is then repeated every 5 minutes as long as the patient continues to be in deep neuromuscular
blockade (defined as a TOF Count of zero). If the TOF Count recovers to 1 or higher, the system switches back to
TOF stimulation.
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PATIENT MONITORING
8 The x-axis (time) can be scaled using the five buttons (15m, 30m, 1hr, 2hr, 8hr) or shifted using the left and
right scroll arrows. Events can be annotated on the time plot by pressing the event marker button( ).
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MENU | STIMULATION PARAMETERS
MENU
The menu can be accessed at any time by touching the menu icon in the upper left-hand
corner of the display. Main menu choices include: Stimulation Parameters, Electrode Array, New
Session, and Device Settings.
MENU
Place Electrode Array on Patient
Stimulation Parameters
Electrode Array
New Session
Device Settings
Press Start to Begin TOF
STIMULATION PARAMETERS
The user can select the Stimulus Type from the MENU Stimulation Parameters
Stimulation Parameters menu, as well as adjust the Stimulus Type TOF
Current, the Pulse Width, and the Repeat Frequency.
Current 60 mA
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MENU | STIMULUS TYPE
STIMULUS TYPE
Four stimulation sequences are available: Train-of-Four, Post-Tetanic Count, Single Twitch, and Tetanus.
Train-of-Four (TOF)
Four stimulation pulses are delivered at 0.5-second intervals. The muscle response is measured after each pulse
and the ratio of the fourth to the first response (T4/T1) is calculated, resulting in a displayed TOF Ratio between
0–100%. If the fourth twitch is below the detection threshold, the TOF Count (the number of detectable twitches)
will be displayed instead of the TOF Ratio.
1hr
30%
2hr
8hr
60 mA 00:10 60 mA 00:10
Note: When the TOF Ratio is ≥ 90% the screen surrounding the TOF Ratio will be displayed in green.
Note: If all four twitches are small, a TOF Count of 4 will be displayed with the TOF Ratio in parenthesis to
indicate poor signal quality.
Note: If the displayed TOF data is over 15 minutes old, a timer will indicate the amount of time elapsed
since the data was obtained.
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MENU | STIMULUS TYPE
Set Repeat 60 mA
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MENU | STIMULUS TYPE
Tetanus
The system delivers a 5-second, 50 Hz tetanic stimulation. EMG is not active. Additional tetanic stimuli are prohibited
for 2 minutes following the last tetanic stimulation.
CANCEL OK
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MENU | CURRENT
CURRENT
The stimulation amplitude can be adjusted from 0 mA to 80 mA in 1 mA increments. If the supramaximal
current (the current required to activate the maximal number of fibers in the stimulated muscle) has
been determined, the value will be displayed above the current adjustment slider (left figure below). If
the supramaximal current has NOT been set, the user will be able to perform a supramaximal current
determination by selecting the Set Supramaximal Current button (right figure below).
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MENU | CURRENT
The Set Supramaximal Current sequence begins at 10mA and increases in 5mA increments until
the increase in current does not increase the measured response. The selected current is increased
by 20% resulting in a supramaximal current.
System Calibrated
S upram ax im al C urrent = 48 m A
CANCEL
Cancel OK
Note: The supramaximal sequence should be performed prior to the administration of neuromuscular blocking agents.
Note: The supramaximal sequence is aborted if the signal is unstable (e.g. the patient is paralyzed) and the current
defaults to 60mA.
Note: Changes in hand or wrist position during patient positioning can alter the current required to elicit a
supramaximal response. To prevent under stimulation, the monitor sets the minimum stimulation current to 48 mA if
the supramaximal current is determined to be less than 48 mA.
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MENU | PULSE WIDTH
PULSE WIDTH
The pulse width can be selected as 100, 200 (default), or 300 μs using the Pulse Width menu.
Stimulus Type
100 us
Current
200 us
Repeat Frequency
Note: A 300 μs pulse width may improve signal quality in select patients (e.g. bariatric patients
or patients with significant edema).
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MENU | REPEAT FREQUENCY
REPEAT FREQUENCY
The repetition frequency of the stimulation sequence can be adjusted (or turned off ) in Repeat Frequency.
The Repeat Frequency ranges are dependent on the specific stimulus type selected:
Tetanus No repeat
10:23 10:23
Current Current
30 sec 30 sec
Pulse Width Pulse Width
10sec
SEC 60min
MIN 10sec
SEC 60min
MIN
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MENU | ELECTRODE ARRAY
ELECTRODE ARRAY
The Electrode Array page shows the status of the
electrode array (green indicates that the lead impedance
is within expected values, whereas red means there
is a problem with the electrode array). The electrode G
impedances are measured prior to each stimulation, and
if a problem is detected, the system will automatically
display the Electrode Array page. Refresh Exit
G
Note: During Quick Start, the system selects the optimal
EMG electrode recording site by measuring the EMG signal 2
EMG
strength at each site and selecting the recording site with the Refresh
largest signal.
Switch EMG
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MENU | NEW SESSION | DEVICE SETTINGS | CLOCK
NEW SESSION
Selecting New Session clears all previous data and returns the system to the Start page.
DEVICE SETTINGS
The device settings menu has the following MENU Device Settings
selections: Clock, Auto PTC, and Screen
Clock OFF
Brightness. Changes to device settings are not
Auto PTC OFF
reset by a new session.
Screen Brightness
Clock 30%
If the clock feature is enabled, the user will be
0% 100%
prompted to set the date and time.
Screen Brightness
Screen brightness can be adjusted between 0 to 100%.
Using a lower screen brightness will prolong battery life
when the Monitor is not in the Charging Station.
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DATA OUTPUT AND CYBERSECURITY CONTROLS | MONITOR CHARGING
The TwitchView System cannot be controlled or otherwise accessed via the external connection. The TwitchView
does transmit data over its ethernet/serial cable, including the TOF Ratio, TOF Count, and PTC Count. The
TwitchView System never contains or transmits Protected Health Information. Transmitted data could be
intercepted by external devices. To avoid unauthorized access to the data, ensure that any external devices to
which the TwitchView are connected are on a trusted network.
MONITOR CHARGING
The TwitchView System uses an inductive charging system that requires no direct electrical contact between the
Monitor and the Charging Station. Charging begins automatically when the Monitor is docked in the Charging
Station, and active charging is indicated by a charging symbol ( ).
If the inductive charging fails, the user will notice the charging symbol does not appear on the Monitor.
Reseat the Monitor in the Charging Station, and if charging does not resume, contact the Manufacturer.
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POWER BUTTON | INFRARED DATA TRANSMISSION
POWER BUTTON
The Monitor has three power states (ON/OFF/STANDBY) that can be accessed via the Power button.
If the device is ON and the Power button is held down, the device enters either STANDBY (if docked in the Charging Station)
or the OFF state (if undocked). If the screen is touched in STANDBY, the device enters the ON state. If the Monitor is removed
from the charging station in STANDBY mode, it enters the OFF state if the screen is not touched within 30 seconds. If the
device is OFF, pressing the Power button causes the unit to enter the STANDBY state.
IR Communication
IR Communication
Location of IR Communication
Port on the back of the Monitor
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TECHNICAL SPECIFICATIONS | CLEANING
Use of EMG leads other than those supplied with the TwitchView may result in serious injury.
Apply supplied electrode to patient’s arm and hand as described in the IFU. Do not place the electrode on the patient’s chest or allow
the stimulating current to pass through the patient’s chest. Do not apply stimulation across or through the head, directly on the eyes,
covering the mouth, on the front of the neck (especially the carotid sinus), or from electrodes placed on the chest and the upper back
or crossing over the heart.
Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
Always make sure that no other equipment can touch the stimulation electrodes.
Electrodes should be applied only to normal, intact, clean skin. Electrodes should not be applied over open wounds or over swollen,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.). Placing electrodes over disrupted
skin may lead to skin irritation, edema, or cellulitis.
Some persons may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel).
Never touch the electrodes unless the stimulation has been stopped.
Do not use in patients with implanted electrical devices, such as cardiac pacemakers, without first consulting an appropriate
medical specialist.
Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes
and possible damage to the stimulator.
Operation in close proximity (e.g. 1 m) to shortwave or microwave therapy equipment may produce instability in the stimulator output.
When removing electrode from patients with sensitive skin (e.g. infants or elderly patients) peel electrode off skin slowly and gently
with a moisteneded gauze sponge. Rapid removal of electrode may tear the skin and increase the risk of cellulitis.
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SHIPPING, STORAGE, AND OPERATING ENVIRONMENT | SYMBOLS
Humidity of all components should be kept between 0% to 95% (non-condensing). Protect the Monitor and Charging Station
from sudden temperature changes that can lead to condensation within the instruments. To minimize condensation, avoid
moving the system between heated buildings and outside storage.
SYMBOLS
Manufacturer name and address Degree of protection against ingress of water (non-protected)
Complies with medical device directive, 93/42/EEC Attention: consult accompanying documents
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DISPOSAL | ELECTROMAGNETIC COMPATIBILITY GUIDANCE
Caution: The TwitchView System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the TwitchView Monitor should be observed to verify normal operation in the configuration in which it will be used.
Caution: Using accessories other than those specified may result in increased electromagnetic emissions or decreased
electromagnetic immunity of the TwitchView System.
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The TwitchView Monitor and Charging Station are intended for use in the electromagnetic environment specified below. The customer or user of the TwitchView Monitor
and Charging Station should ensure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment- Guidance
Floors should be wood, concrete or ceramic tile. If floors are
Electrostatic Discharge IEC Contact +/- 8kV Contact +/- 8kV
covered with synthetic material, the relative humidity should
61000-4-2 Air: +/- 2kV, +/-4kV, +/-8kV, +/-15kV Air: +/- 2kV, +/-4kV, +/-8kV, +/-15kV
be at least 30%.
Portable and mobile communications equipment should be
3V/m 3V/m separated from the TwitchView System by no less than the
80MHz to 2.7GHz 80MHz to 2.7GHz distances calculated below:
Radiated Immunity IEC
D = (3.5/3)*(Sqrt P): 80 to 800 MHz
61000-4-3
AC Mains: AC Mains: D = (7/3)*(Sqrt P): 800 MHz to 2.5 GHz
3 Vrms & 6Vrms 3 Vrms & 6Vrms
Conducted Immunity IEC 150kHz to 80MHz 150kHz to 80MHz Where P is the max power in watts and D is the recommended
61000-4-6 separation distance in meters. Field strengths from fixed
IO lines: IO lines: transmitters as determined by an electromagnetic site surveya
3 Vrms & 6Vrms 3 Vrms & 6Vrms should be less than the compliance levels in each frequency
150kHz to 80MHz 150kHz to 80MHz rangeb. Interference may occur in the vicinity of equipment
containing a transmitter.
Electrical Fast Transient Burst AC Mains: 2kV, 100kHz PRF AC Mains: 2kV, 100kHz PRF Mains power should be that of a typical commercial or
IEC 61000-4-4 DC Mains: NA DC Mains: NA hospital environment.
AC Mains: +/- 0.5kV and +/-1kV line
to line AC Mains: +/- 0.5kV and +/-1kV Mains power should be that of a typical commercial or
Surge IEC 61000-4-5
DC Mains : NA line to line hospital environment.
IO Mains : NA
Power frequency magnetic fields should be at levels
Magnetic Immunity IEC
30A/m; 50Hz and 60Hz 30A/m; 50Hz and 60Hz characteristic of a typical location in a typical commercial or
61000-4-8
hospital environment.
0% for 0.5 cycle
Voltage Dips and Interrupts 0% for 1 cycle Mains power should be that of a typical commercial or
No effect
IEC 61000-4-11 70% for 25/30 cycles hospital environment.
0% for 250/300 cycles
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.
a
Field 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 TwitchView system is used exceeds the applicable RF compliance level above, the TwitchView
system should be observed to verify normal operation. If abnormal performance is observed, additional measures may by be necessary, such as reorienting or relocating the
TwitchView System
b
Over the frequency ranges 150kHz to 80 MHz field strength should be less than 3 V/m.
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ELECTROMAGNETIC COMPATIBILITY GUIDANCE
The TwitchView Monitor and Charging Station are intended for use in the electromagnetic environment in which RF disturbances are
controlled. The customer or user of the TwitchView System can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the TwitchView System as recommended
below, according to the maximum output power of the communications equipment.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency ranges 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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SOFTWARE LICENSE
The computer software (“Licensed Software”) loaded on the TwitchView Monitor (“System”) is licensed,
not sold, to you for use only under the terms of this license. Blink Device Company (Blink) reserves any
rights not expressly granted to you. You own the System, but Blink retains all ownership rights and title to
the Licensed Software itself.
Customer is hereby granted a non-exclusive, limited, non-transferable license to use the programmed
logic, computer programs and/or software (“Software”) supplied by Blink, in connection with, and
incorporated into, the System internally, but only in the form in which delivered to customer and for
the sole purpose of operating in accordance with written instructions provided to customer(and for no
other product or purpose). The Software, and all modifications, enhancements and upgrades thereto,
will, at all times, remain the property of Blink. Customer may not, and may not permit anyone else to,
duplicate, copy, reverse-engineer, de-compile, or disassemble the Software or in any way modify the
Software. Customer has no right to, and may not, create derivatives of the Software, and customer may
not attempt to copy, create or re-create the source code of the Software. Any and all such modifications
or enhancements to the Software in contravention of this license will immediately become the sole
property of Blink and Customer hereby assigns all title, ownership and interest in such modifications and
assignments to Blink. In the event of a failure by customer, or its agents, employees or representatives,
or third-party end-users, to comply with any terms and conditions of the License herein granted, the
License will, without any further action by Blink or any other party, immediately terminate. If you transfer
the System, you have the right to transfer the Licensed Software provided that the transferee agrees to
be bound by the terms and conditions of this License Agreement.
This License Agreement will be construed under the laws of the State of Washington. If any provision
of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law, that
provision will be enforced to the maximum extent permissible, and the remaining provisions of this
Agreement will remain in full force and effect.
Should you have any questions concerning this License Agreement, you may contact Blink by writing to
the address listed on the back cover of this manual.
THIS LICENSE AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE SOFTWARE LICENSE
AGREEMENT BETWEEN YOU AND BLINK AND SUPERSEDES ANY PROPOSAL OR PRIOR AGREEMENT, ORAL
OR WRITTEN, AND ANY OTHER COMMUNICATIONS BETWEEN YOU AND BLINK RELATING TO THE SUBJECT
MATTER OF THIS SOFTWARE LICENSE AGREEMENT.
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Blink Device Company
1530 Westlake Ave N. # 600
Seattle, WA 98109
U.S.A.
(Tel) 206.708.6043
www.blinkdc.com