SENZIME TetraGraph SEN 2001 User manual

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07
Neuromuscular Transmission Monitor
Operang Instrucons
TetraGraph Model SEN 2001

2 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
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1. Baery symbol with charge status indicaon light.
2. ON switch
3. Cable connector for the TetraCord paent cable.
4. Aachment for the TetraGraph pole clamp.
5. RS 232 port interface for mul-parameter paent monitors.
6. USB-port for the USB cable (power supply and data upload).
Device layout

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 3
Start screen layout
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810
7. Baery capacity symbol and precentage
8. External monitor indicaon
9. Seng symbol
10. OFF switch
11. Auto start buon
12. Manual start buon
13. Sensor indicaon symbol
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4 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
Contents
1. Introducon....................................................................................................... 5
2. Warnings and Cauons...................................................................................... 5
3. Scope of Use and Contraindicaons.................................................................. 5
4. Intended Users .................................................................................................. 6
5. Modes of Operaon .......................................................................................... 6
6. Train of Four (TOF), TOF Rao (TOFR) and TOF Count (TOFC) ........................... 7
7. Post-Tetanic Count (PTC) ................................................................................... 8
8. Single Twitch (ST)............................................................................................... 9
9. Associated Devices and Accessories.................................................................. 9
10. Summary of Warnings, Cauons and Side-Eects........................................... 11
11. Symbols and Icons........................................................................................... 12
12. Geng Started ................................................................................................ 14
13. Seng Up........................................................................................................ 15
14. TetraSens Electrodes ....................................................................................... 16
15. Operaon ........................................................................................................ 19
16. Data output and cybersecurity controls .......................................................... 30
17. Troubleshoong .............................................................................................. 30
18. Maintenance and Baery Charging................................................................. 32
19. Cleaning and Disinfecng ................................................................................ 34
20. Performance and Technical Specicaons ...................................................... 35
21. Environment.................................................................................................... 37
22. Electromagnec Compability Informaon .................................................... 37
23. Product Warranty............................................................................................ 39
24. Disposal of Waste Electrical and Electronic Equipment .................................. 39

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 5
1. Introducon
These instrucons are intended to assist with the operaon of the TetraGraph Neuro-
muscular Transmission (NMT) monitor and its TetraSens electrodes.
A NMT monitor such as the TetraGraph is intended to supplement clinical informaon
obtained with other monitors, such as peripheral oxygen saturaon (SpO2), end-dal
carbon dioxide (ETCO2), as well as clinical assessment, to determine the adequacy of
venlaon.
Always check the TetraGraph monitor and ensure it is able to complete the self-check
sequence when rst turned on. Inspect the device and associated accessories for any
physical damage or missing parts.
2. Warnings and Cauons
Internaonal Medical Device Standards require all manufacturers to include appropri-
ate warnings and cauons for their equipment and many of the warnings and cau-
ons shown here also apply to similar devices.
To make sure that all users are well informed, various warnings and cauons are
made throughout these instrucons.
A WARNING is given when the personal safety of the paent or user may be aected and
when disregarding this informaon could result in injury.
A CAUTION is given when special instrucons must be followed. Disregarding this informa-
on could cause damage to the device.
3. Scope of Use and Contraindicaons
The Intended Use of the TetraGraph is to deliver smulaons to a nerve and record,
measure, analyse and report muscle electrical acvity to determine muscle funcon.
TetraGraph is a Neuromuscular Transmission (NMT) monitor intended for use in
hospital sengs including operang rooms, subsequent recovery areas and in crical
care sengs. The device is for use with paents (excluding neonates), and where the
paent is mechanically venlated and when a neuromuscular block has been admin-
istered.
Neuromuscular Transmission is the transfer of an electrical impulse between a motor
nerve and its associated muscle. NMT is blocked by neuromuscular blocking agents
(NMBA) which cause transient muscle paralysis, prevenng the paent from moving
and breathing spontaneously.
Muscle relaxaon is used during general anaesthesia to enable endotracheal intuba-
on and to provide opmal surgical condions. In crical care, muscle relaxaon may
be used during mechanical venlaon. In these sengs, TetraGraph can be used as
an objecve monitor of neuromuscular transmission.
Paents with pre-exisng neuromuscular disease (Myasthenia Gravis, Dystrophy etc.)
or paents with cerebrovascular accidents (CVAs or Stroke) may have unexpected

6 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
electromyographic responses that may aect the results of the monitoring. Place the
EMG responses in appropriate clinical context.
NOTE: TetraGraph is not for use in MRI environment (it is not MRI compable).
WARNING Paents with an implanted electronic device such as a cardiac pacemaker must
not be subjected to electrical smulaon unl specialist medical opinion has been obtained
WARNING Do not use in a ammable atmosphere or in places where ammable anesthecs
may concentrate.
3.1 Indicaons for use statement
The TetraGraph Neuromuscular Transmission (NMT) monitor is indicated for monitor-
ing the relaxaon of the paent when neuromuscular blockade is administered.
The TetraGraph device is for prescripon use only. (US only)
3.2 Clinical Benets
The major benet to the paent, provided by TetraGraph, is the ability to monitor the
degree of neuromuscular block when NMBAs are administered in conjuncon with
surgery and/or mechanical venlaon and assistance in detecng residual neuromus-
cular weakness.
The use of TetraGraph is intended to supplement clinical informaon obtained with
other monitors, such as peripheral oxygen saturaon (SpO2), end-dal carbon dioxide
(ETCO2), as well as clinical assessment, and these must remain the main paent
monitors to determine the adequacy of venlaon. Clinical decisions are never based
solely on data from TetraGraph. Thus, informaon obtained from TetraGraph should
be considered as supplementary for paent management decisions.
4. Intended Users
TetraGraph must be operated by trained and competent clinical sta and used in ac-
cordance with approved clinical pracce and local guidelines and recommendaons.
5. Modes of Operaon
A Neuromuscular Transmission (NMT) monitor shows the presence of a neuromuscu-
lar block by smulang a peripheral motor nerve and evaluang the evoked muscle
response. TetraGraph undertakes this funcon by periodically applying electrical
smulaon to the peripheral nerve and directly measuring the evoked electromyo-
graphic (EMG) response of the muscles. This provides a quantave and automac
measurement of muscle response to a smulus.
TOF mode, TetraGraph’s main mode of operaon, is the delivery of a sequence of
four smuli called a Train of Four (TOF) and calculang the Train of Four Rao (TOFR,
which is the rao of the amplitude of the fourth response to the amplitude of the rst
response) and TOF Count (TOFC) from the evoked EMG responses. TOF smulaon is

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 7
commonly used in assessing depth of neuromuscular blockade and recovery during
reversal. The rst response in the TOF sequence (T1) (before the administraon of
any neuromuscular block) is stored as a T1 baseline against which further measure-
ments may be compared. A T1 baseline above 5 mV indicates an adequate response
to provide a good EMG measurement throughout the procedure.
The four evoked response amplitudes are displayed as a sequenal bar graph, along
with the calculated TOFR or TOFC. The four underlying EMG waveforms recorded by
the TetraGraph may alternavely be displayed. In both cases, the vercal axis of the
bar graph is automacally scaled.
In bar graph display mode, where no EMG response can be idened by the moni-
tor, the posion of the response will be marked by a red rectangle indicang that a
measurement was aempted but no response was idened.
Other operang modes available are Post-Tetanic Count (PTC) and Single Twitch (ST).
PTC mode executes a tetanic smulaon protocol, in which a high frequency smulus
is applied, followed by a sequence of 1 Hz smuli. PTC mode may only be used when
the TOFC is zero.
ST Mode delivers a single smulus and displays a single response, repeated every
10 seconds. The rst measurement, commonly at the start of the procedure (before
the administraon of any neuromuscular block) is stored as a baseline against which
further measurements may be compared. The sequence of responses is displayed as
a scrolling sequence of bars, with the most recent measurement being adjacent to
the baseline amplitude bar.
The ST baseline may be reset by pressing on the base line value and the arrow next to
the value.
6. Train of Four (TOF), TOF Rao (TOFR) and TOF
Count (TOFC)
The baseline Train of Four Rao (TOFR) is determined before administraon of neu-
romuscular blocking agents, but aer inducon of general anesthesia. The base-
line TOFR (before administraon of a neuromuscular block) is displayed as 100%,
represenng a rao of 1.0. During a paral non-depolarizing block, the percentage
decreases as the degree of block increases.
Thus, as the degree of block increases, the rao decreases from 100%. As the TOFR
approaches 0%, the fourth response in the train (T4) disappears, and only three
responses remain - a TOF Count (TOFC) of 3. Decreases in amplitudes connue as the
depth of neuromuscular block increases, unl T3 disappears, and the TOFC is 2. When
T2 disappears and only T1 remains, the TOFC is 1, and when T1 disappears, the TOFC
becomes 0.

8 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
When depolarizing agents such as succinylcholine (suxamethonium) are used, there is
usually no fading, and the TOFR remains close to 100% unl all responses disappear.
7. Post-Tetanic Count (PTC)
When the Train of Four Count (TOFC) reaches 0, TetraGraph enables its Post Tetanic
Count (PTC) mode. PTC mode is only operable when the TOFC is 0.
When PTC mode is selected, TetraGraph takes a new TOF reading to check the Train
of Four Count (TOFC) equals zero. When this requirement is sased, PTC sequence
commences.
The tetanic smulaon consists of a 50 Hz tetanic smulus with a current amplitude
of 50 mA and a pulse duraon of 200 µs lasng for 5 seconds, followed 3 seconds
later by up to 20 separate single response smulaons at 1 Hz.
PTC is the number of responses detected following a Tetanic smulaon. The monitor
will stop the smulang and counng when a response is no longer detected. Thus,
the PTC may be a number between zero and 20, zero indicang a complete level of
neuromuscular block.
Aer delivery of a PTC sequence, the TetraGraph disables PTC mode for at least 2
minutes. PTC interval of 2, 3 or 5 minutes can be selected by pressing the icon interval.
Repeon of PTC measurements faster than every 2 minutes may result in an inaccu-
rate measurement because of post-tetanic potenaon (amplicaon) of responses.
On demand PTC or repeated PTC can be selected in sengs.
On demand PTC selected
When on demand PTC is selected, the unit will run one PTC measurement sequence.
Thereaer the device will return to TOF mode. To run another PTC sequence, the PTC
buon should be pressed.
Repeated PTC selected
When Repeated PTC is selected, the unit will run PTC sequences repeatedly unl the
precondions for PTC is not fullled (TOFC is not zero). To re-iniate repeated PTC,
the PTC buon should be pressed.

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 9
8. Single Twitch (ST)
Single Twitch (ST) is a single smulus used by the monitor to display the peak-to-peak
amplitude of the muscle response in millivolts (mV). The frequency of smulaon is
0.1 Hz, corresponding to one smulus every 10 seconds. ST at a frequency of 1 Hz
(one smulus per second) is delivered as part of the PTC sequence (see above).
Single Twitch (ST) is used in two dierent sengs:
1. To determine the onset of paralysis during neuromuscular relaxaon as a guide
for readiness for tracheal intubaon.
2. As part of the PTC sequence (see secon 7).
9. Associated Devices and Accessories
The associated devices and accessories supplied with the TetraGraph are the Tetra-
Cord Paent Cable and the power supply with USB cable. The required TetraSens
Electrodes are sold separately.
NOTE: Only TetraSens Electrodes should be used with the TetraGraph.
WARNING: Reuse of TetraSens may lead to inaccurate measurement due the drying or loss
of hydrogel and adhesive properes. Addionally, electrode re-use may lead to cross-con-
taminaon or supercial burns.
WARNING: Use of other electrodes than TetraSens can causeinaccurate measurement and/
or supercial burns.

10 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
The rechargeable baery is charged using the AC Adapter. This Adapter is congured
for local power outlets and connects to the TetraGraph using a USB cable.
NOTE: The TetraGraph may not be operated, nor connected to a paent to perform
monitoring, whilst connected to a computer. The TetraGraph must only be used with
the supplied power supply adapter.
The USB port is also an interface for transferring data to a PC running the TetraCon-
nect.*
The RS-232 port allows connecon to external mul-parameter monitors or commu-
nicaon hubs. For connecon to Philips IntelliVUE monitors, the TetraGraph Philips
Interface cable is needed and for connecon to CapsuleTech´s connecvity hubs Axon
and Neuron the TetraGraph xcom is needed.
In addion, the user may also require: SEN 2101 TetraGraph Pole Clamp Kit (Oponal)
for aachment of the TetraGraph to a IV pole.
*A cloud-based service for use on computers, tablets and smartphones intended for
import, view and search in data records generated with TetraGraph.

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 11
10. Summary of Warnings, Cauons and Side-Eects
In common with all medical devices of this nature there are inherent risks and side
eects. Whilst every eort has been made to eliminate these risks, care should be
taken when using the device. It is important that the user familiarizes himself/herself
with all of the warnings and cauons contained within this document.
WARNINGS
Do not use in a ammable atmosphere or in places where ammable anesthecs may concen-
trate.
Paents with an implanted electronic device such as a cardiac pacemaker must not be sub-
jected to electrical smulaon unl specialist medical opinion has been obtained.
TetraGraph is not for use near shortwave or microwave therapy equipment as this can cause
unwanted smulaon in the electrodes and incorrect operaon.
If the electrosurgical grounding fails, skin burns may occur at the site of the electrodes.
Reuse of TetraSens may lead to inaccurate measurement due the drying or loss of hydrogel
and adhesive properes. Addionally, electrode re-use may lead to cross-contaminaon or
supercial burns.
Use of other electrodes than TetraSens can cause inaccurate measurement and/or supercial
burns.
Only apply electrodes to clean, dry skin without signs of damage such as burns or inamma-
on.
Some taoo pigments are ferromagnec and can, when subjected to electrical smulaon,
cause skin burns.
The Device should be used only with the leads and electrodes recommended for use by the
manufacturer.
The long-term eects of chronic electrical smulaon are unknown.
Smulaon should not be applied over the carod sinus nerves, parcularly in paents with a
known sensivity to the carod sinus reex.
Smulaon should not be applied over the neck or mouth. Severe spasm of the laryngeal and
pharyngeal muscles may occur and the contracons may be strong enough to close the airway
or cause diculty in breathing.
Smulaon should not be applied transthoracically in that the introducon of electrical current
into the heart may cause cardiac arrhythmias.
Smulaon should not be applied transcerebrally.
Smulaon should not be applied over swollen, infected, or inamed areas or skin erupons,
e.g., phlebis, thrombophlebis, varicose veins, etc.
Smulaon should not be applied over, or in proximity to, cancerous lesions.
Cauon should be used for paents with suspected or diagnosed heart problems.
Cauon should be used for paents with suspected or diagnosed epilepsy.
Cauon should be used in the presence of the following:
a. Over the menstruang or pregnant uterus; and
b. Over areas of the skin which lack normal sensaon.
Some paents may experience skin irritaon or hypersensivity due to electrical smulaon
or electrical conducve medium, such as clinical adhesive or hydrogel. The irritaon may be
reduced by using an alternate electrode placement.

12 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
CAUTIONS
Before use, ensure the monitor is intact and the baery is fully charged or connected to power
supply. Also visually inspect the device and the TetraCord cable for any loose or damaged parts.
If the performance of the device changes from that specied, required or expected, take the
device out of service immediately.
Maintenance work must be conducted by trained personnel following the manufacturer’s
guidelines.
Do not use abrasive cleaners on the display.
Before cleaning, disconnect the power unit from the mains electrical supply. The TetraGraph
and its cables must NOT be immersed in water or other liquids during cleaning or disinfecon.
Twisng the cable or pulling violently when disconnecng from the TetraGraph monitor may
cause damage to the TetraCord paent cable.
SIDE EFFECTS
The side eects that can occur from use of TetraGraph and its TetraSens Electrodes are the
following:
Allergic reacon to clinical adhesive or hydrogel.
Localised irritaon if smulaon electrodes are not securely ed or are reused.
Neurosmulaon using maximal currents may induce pain in un-anaesthesed paents.
Paent may experience skin irritaon and burns beneath the smulaon electrodes applied to
the skin.
11. Symbols and Icons
The following symbols are used on the TetraGraph device and its display, and on the
TetraSens electrode.
The following symbols are seen on the labels of the TetraGraph.
2797
CE mark and
noed body
number
Indicates compliance with European Medical Device regulaons.
Symbol is associated with a number indicang the Noed Body.
SN Serial number The unique serial number allocated to the device.
Reference
number The catalogue or model number of the device.
Operang
instrucons
The device has instrucons for use.
Consult the instrucons for use.
Refer to instruc-
on manual You must read the instrucons for use.
General warning
sign Shows important informaon.
Keep dry Product should be kept dry.

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 13
Keep away from
sunlight Do not leave in direct sunlight or close to sources of excessive heat.
Date of manu-
facture Date of manufacture, shown as year and month.
Manufacturer Name and address of the manufacturer.
FCC mark
FCC mark is a cercaon mark employed on electronic products sold
in the United States which ceres that the electromagnec interfer-
ence from the device is under limits approved by the Federal Communi-
caons Commission.
UL mark TetraGraph is cered by UL.
MR unsafe The TetraGraph instrument is not MRI safe.
Medical Device TetraGraph is a medical device.
Unique Device
Idencaon
The Unique Device Idencaon (UDI) is a system used to mark and
idenfy medical devices within the healthcare supply chain.
For prescripon
use only
Federal law in U.S. restricts this device to sale by or on the order of
a medical praconer licensed by the law of the state in which he
pracces.
WEEE Do not dispose of in domesc waste, see chapter 24.
Humidity Transport and storage humidity limits
Pressure Transport and storage pressure limits
Temperature Storage temperature limits
Temperature Transport temperature limits
BF Debrillator
Applied Part
Protecon against the eects of the discharge of a cardiac debrillator
is dependent on the use of the specied cable and electrodes.
Universal Serial
Bus (USB) USB port for charging and downloading les.
Monitor Connec-
on Port for monitor cable see chapter 9.

14 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
The following addional symbols are used on the electrodes.
CE mark
The CE Mark w/o any numbers indicated the product is a
self-cered Class I Medical Device. This symbol applies to
TetraSens Electrode.
UKCA mark
The UKCA Mark w/o any numbers indicated the product is
a self-cered Class I Medical Device. This symbol applies
to TetraSens Electrode.
Batch Code Lot number of the device.
Do not use if package
is damaged For the TetraSens Electrode pouch.
Do not reuse For the TetraSens Electrode – single use only.
Non-sterile For the TetraSens Electrode
Use by date For the TetraSens Electrode
The following symbols are used on the TetraGraph power supply.
IEC 60417-5172 Class II equipment.
IEC 60417-5032 Alternang current.
IEC 60417-5031 Direct current.
12. Geng Started
The system as delivered includes the following items:
SEN 2001 TetraGraph monitor
SEN 2100 TetraCord Paent Cable / SEN 2111 TetraCord Paent Cable
SEN 2201 USB power supply adapter (FRIWO model No. FW8002.1MUSB/05)
SEN 2202 Baery, installed in the TetraGraph (Varta part No. 56456 702 099)
SEN 2207 USB cable, 3m (type A plug to type B plug) to connect the power supply
SEN 008 Operang Instrucons (this document)
Accessories:
SEN 2002 Box of 20 TetraSens electrodes (each SEN 1002)
SEN 2009 Box of 15 TetraSens Pediatric electrodes (each SEN 1009)
SEN 2014 Box of 15 TetraSensive electrodes (each SEN 1012)
Oponal accessories:
SEN 2101 TetraGraph Pole Clamp Kit
SEN 2007 TetraGraph Philips Interface
SEN 2010 TetraGraph Xcom cable
On receipt and aer periods of storage, clean and disinfect the TetraGraph before us-
ing it. Further instrucons are detailed in chapter 19.

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 15
CAUTION Before use, ensure the monitor is intact and the baery is fully charged or con-
nected to power supply. Also visually inspect the device and the TetraCord cable for any
loose or damaged parts.
13. Seng Up
Do the following:
Connect the TetraGraph to power using the USB cable and AC Adapter included in the
system. Connect the USB cable to the USB port on top of the TetraGraph.
Alternavely charge the installed rechargeable baery before use with the supplied
power supply.
Turn the TetraGraph on by pressing the ON switch on the front panel.
The screen illuminates, and the monitor performs a brief self-test.
The blue bar lls from le to right, the soware version of the device is displayed,
and the display progresses to the next screen.
Soware version may also be displayed when the device is switched o. See secon
15.
SW Version xxx.xxx.xxx

16 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
14. TetraSens Electrodes
Before the electrodes are placed on the skin, make sure the skin surface is clean and
dry.
Place the electrode on the hand before connecng the electrodes to the TetraGraph
monitor using the cable provided.
The electrodes can be applied to either hand, with the smulang electrodes over
the ulnar nerve at the wrist and the evoked response recorded from either the
hypothenar muscle below the lile nger (abductor digi minimi muscle), the thenar
muscle below the thumb (adductor pollicis muscle) or the rst dorsal interosseous
muscle on the back of the hand as illustrated below.
If surgery is being conducted on an arm, place the TetraSens electrodes on the oppo-
site arm avoiding nonsterile electrodes in the proximity of the surgical site and in the
case of high frequency (HF) electrocautery reducing the eect of potenal interfer-
ence.
To aach the electrodes, do the following:
Clip to remove hair if necessary, and lightly abrade with a clean gauze sponge. Tear
the pouch open (do not use scissors) and remove the TetraSens Electrodes from the
pouch.
Remove the smulang (proximal, square) electrodes from the liner by liing the
edge of the electrodes and then apply them over the ulnar nerve (nervus ulnaris) as
illustrated below.
{
1 cm
Place the oval smulang
electrodes over the ulnar nerve
Wrist crease

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 17
Remove the recording (distal, round) electrodes from the liner by liing the edge of
the electrodes and then apply them as illustrated below.
Connect the TetraCord cable to the electrodes. On SEN 2100 by squeezing the tabs on
the side of the cable connector and fully inserng the blue poron of the TetraSens
electrode connector into the cable connector, ensuring the correct orientaon as
illustrated; then, release the tabs. On SEN 2111 by opening the lid, fully inserng the
blue poron of the electrode into the connector and close the lid.
Part number SEN 2100
Part number SEN 2111

18 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
Correct versus Incorrect posioning of the
TetraSens electrode inserted into the connector
Correct versus Incorrect posioning of the
TetraSens Pediatric and TetraSensive electrode
inserted into the connector
Note: It is important to overcome the resistance and fully insert the sensor into the
cable connector. When correctly posioned, the blue line on the sensor is no longer
visible.
Electrodes must be discarded if they no longer sck rmly to the skin. Ensure that no
other equipment gets in contact with the smulang or recording electrodes.
Connect the TetraCord cable to the TetraGraph monitor by inserng the cable straight
into the monitor, DO NOT TWIST the cable. The black arrow mark on the cable con-
nector should line up with the cutout on the connector/port in the monitor.
As illustrated below, secure the cable to the forearm with tape to reduce stress on
the connecon as a result of movement.

INSTRUCTIONS FOR USE TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 19
To remove the electrodes, do the following:
Turn the TetraGraph monitor o.
Disconnect the TetraCord cable from the TetraSens electrodes by squeezing the tabs
on the side (SEN 2100) or by opening the lid (SEN 2111) of the cable connector.
Remove the electrode from the skin by gently peeling from the edge.
Remove possible gel residue from the skin.
Dispose of used electrodes as clinical waste.
15. Operaon
Check that the unit has adequate baery life, as
indicated in the top le corner of the screen, or is
connected to power supply. A 100% baery charge
gives approximately 8 hours of connuous use with a
new baery in good condion.
Press Sengs to set Brightness, Sound, PTC mode,
Date/Time, Paent Reference.
The screen indicates the eecveness of the elec-
trode in contact with the skin by changing the colour
of the icons for the smulang electrodes and
evoked response sensors.
GREY indicates that the paent cable or the smulang or recording electrode pairs
are not connected to the paent and the monitor will pause smulaon unl con-
nected correctly.
GREEN indicates that the electrode is correctly connected, and the impedance is
within acceptable limits to deliver the requested smulus current or to record the
response.
For troubleshoong see secon 17.
WARNING TetraGraph is not for use near shortwave or microwave therapy equipment as this
can cause unwanted smulaon in the electrodes and incorrect operaon

20 TetraGraph Model SEN 2001, SEN 008, Issue 14.0, 2023-11-07 INSTRUCTIONS FOR USE
If Sengs is selected, the screen to the le appears.
Press + or – to increase or decrease the brightness.
To turn the sound on/o press
To select PTC mode, press
To select Date and Time press the arrow and press YY/
MM/DD to alternate between the date and format
opons. Date format are available in three opons:
YY/MM/DD, DD/MM/YY, MM/DD/YY.
To add Paent Reference, press the arrow and insert
Paent Reference ID.
Press Paent Data and Delete Data to delete all Pa-
ent Data.
Before use, ensure the monitor is intact and the baery is fully charged or connected to
power supply. Also visually inspect the device and the TetraCord cable for any loose or dam-
aged parts