Interacoustics TRV chair User manual

Instructions for Use – EN
TRV chair
Science
made
smarter
8522633 - D-0125111-A – 2020/04

Contents
1Introduction.......................................................................................................................................... 1
1.1 About this manual ......................................................................................................................... 1
1.2 Intended use ................................................................................................................................. 1
1.3 Contraindications .......................................................................................................................... 1
1.4 Product description ....................................................................................................................... 1
1.5 Notes on safety............................................................................................................................. 2
1.6 Safety precautions ........................................................................................................................ 2
1.7 Meaning of symbols used ............................................................................................................. 4
2System description and performance............................................................................................... 5
3Using the chair................................................................................................................................... 13
3.1 Precautions for use – basic safety rules..................................................................................... 13
3.2 Seating the patient...................................................................................................................... 15
3.2.1 Fitting the harness: ................................................................................................................. 16
3.2.2 Placing the headrest: .............................................................................................................. 17
3.3 Emergency exit ........................................................................................................................... 19
3.4 Charging the battery ................................................................................................................... 19
4Diagnostic maneuvers protocol proposal ...................................................................................... 23
4.1 General ....................................................................................................................................... 23
4.2 Characteristics of positional nystagmus ..................................................................................... 28
4.3 Therapeutic maneuvers: protocol proposal for the right posterior canal .................................... 29
4.3.1 Therapeutic maneuvers: protocol proposal for lateral canal cupulolithiasis........................... 31
4.3.2 Therapeutic maneuvers: protocol proposal for the anterior canal .......................................... 32
5Maintenance and care....................................................................................................................... 33
5.1 Liability ........................................................................................................................................ 34
5.2 Guarantee................................................................................................................................... 34
6Technical specifications................................................................................................................... 35
6.1 Electromagnetic Compatibility (EMC) ......................................................................................... 36

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 1
1Introduction
1.1 About this manual
This manual is valid for the TRV chair. The equipment is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
1.2 Intended use
The TRV chair is intended to assist in the diagnosis and treatment of balance disorders and vertigo,
including benign paroxysmal positional vertigo (BPPV).
Intended user
The TRV chair is intended to be used by an audiologist, ENT, physiotherapist and/or hearing healthcare
professional or technician. Every user must be certified as a trained user.
1.3 Contraindications
The TRV chair must not be used if the patient presents with unusual headache symptoms, uncontrolled
high blood pressure, some associated neurological symptoms or any other atypical findings. It must not
be used if the patient has undergone neurosurgery or cardiac surgery within the past month.
For US only: Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a
licensed medical practitioner.
1.4 Product description
The Vertigo Treatment and Rehabilitation (TRV) chair is designed for diagnostic and therapeutic
maneuvers in positional vertigo. The chair is manually handled by a health professional specialized in
balance/vertigo troubles.
The chair allows for 360° rotation around the vertical and horizontal axes with lockable pre-set positions,
in order to place the patient’s head in certain angles for specific maneuvers.

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 2
1.5 Notes on safety
Throughout this manual, the following meanings of warnings, cautions and notices apply:
The WARNING label identifies conditions or practices that may present
danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
1.6 Safety precautions
Follow Instructions for Use - To ensure correct use of the medical device,
it is essential to read this documentation and all the instructions and labels
carefully and thoroughly.
This device must not be used with patients smaller than 140 cm nor taller
than 195 cm, or with patients that weigh more than 150 kg.
The system should not be used in areas of high humidity.
The system should not be exposed to explosive or flammable gases.
The system should only be used by persons who have been trained in its
use and who are medically qualified in the field of vestibulometry.
In the event of damage to the system or any of its components, it must be
repaired before further use.
The device must be cleaned after each utilization.
After/before every manipulation, the user must clean every part in contact
with the patient (shoulders, shims, seat, headrest, head strap) with the
specified cleaning agent.
Always switch the system off before cleaning.
The device must be powered off after each utilization.
After every manipulation, the user must switch off the device to avoid any
unintended activation of the frame, which could hurt the user and the
patient.
WARNING
CAUTION
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 3
Always use the handles to manipulate the device.
Failure to use the handles during maneuvers may incur pinch / trapping
danger and potential damages.
The device may only be used for patients between 140 and 195 cm.
The device is designed to manipulate patients within a certain range of
size (140 cm < S < 195 cm), in order to ensure safe use.
The device must NOT be used for patients that weigh more than 150 kg.
The device is designed to manipulate patients within a certain range of
weight (W < 150 kg), in order to ensure safe use.
In case of a serious incident, the manufacturer should be notified as well
as the competent authority in the patient’s home country.
No modification of this equipment is allowed without authorization from
Interacoustics.
No parts of the equipment can be serviced or maintained while in use with
the patient.
Risk of dizziness.
As the chair allows for 360° rotation.
The use, sale and distribution of the system may be regulated, so it is
essential to ensure that the device is compliant with any local regulations
before being put to use.
Within the European Union, it is illegal to dispose of electrical and
electronic waste as unsorted municipal waste. Electrical and electronic
waste may contain hazardous substances and must therefore be
disposed of separately. Such products will be marked with the crossed-out
wheelie-bin image shown to the left. User cooperation is important in
order to ensure a high level of reuse and recycling of electrical and
electronic waste. Failure to recycle such waste products in an appropriate
way may endanger the environment and consequently the health of
human beings.
Outside the European Union, local regulations should be followed when
disposing of the product.
WARNING
WARNING
WARNING
CAUTION
CAUTION
WARNING
WARNING
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 4
1.7 Meaning of symbols used
SYMBOL
DESCRIPTION
Follow Instructions for Use
General warning sign
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive 93/42/EEC
Manufacturer
Date of manufacture
Serial number
Fragile, handle with care
Transport and storage temperature range
Transport and storage humidity limitations
Keep dry
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to dispose of
this product, it must be sent to separate collection facilities for
recovery and recycling.
Direct Current
GREEN indicator
Primary frame is unlocked

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 5
2System description and performance
The TRV chair has a seat equipped with supports (four-point harness, headrest with headband and leg
strap) and has two axes of rotation, which are lockable in pre-set positions.
The horizontal axis is locked by the means of an electromagnetic lock (footswitch operated), with the
patient in one of the following positions:
1. Standard (vertical, head at top).
2. 30° above the horizontal plane for caloric tests.
3. 0° or 180° (supine decubitus, left or right decubitus or ventral decubitus).
)
4. Immobilization -45° or +225° (45° below the horizontal plane, head to left or right) for ‘potentiated’
Epley maneuver:

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 6
The vertical axis can be locked by the means of a manually operated lock, with the patient in the standard
position (facing the operator) and then locked at every subsequent 45°:
A movable counterweight under the patient’s seat can be moved to align the patient’s center of gravity
with the vertical axis of rotation:
This will ensure a well-balanced rotation during diagnostic procedures and during the barbecue
maneuvers.
The height position of the headrest and the headband can be adjusted to the patient’s height by means of
a pneumatic lift. The operator pushes a release button and raises or lowers the headrest so that it is in
line with the patient’s head position:
On very light patients: Slide the
counterweight towards the patient’s
knees.
On very heavy patients: Slide the
counterweight away from the patient’s
knees.
Counterweight with manual lock
to lock the counterweight in the
optimal position for each patient.
The counterweight must be in
the central position for patients
of average weight (60-90 kg).

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 7
The chair enables the operator to rotate the patient in planes that are very close to the planes of each of
the semicircular canals:
Rotations 45° from the sagittal plane will stimulate the anterior or posterior canals, and barbecue rotations
along the vertical plane will stimulate the horizontal canals.
These maneuvers are possible in more than full-circle rotations (+360°).
Rotation must only be performed on one axis at a time.
CAUTION
Release button:
Press and hold to
adjust the position of
the headrest.

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 8
Maneuvers on the horizontal axis can be arrested in two positions by means of a retractable stop:
•In the horizontal plane (for Dynamic Particle Repositioning Maneuvers (DPRM), also known as
the TRV maneuver).
•At 45º below the horizontal plane (for Sémont and Epley maneuvers) to increase therapeutic
efficacy:
Stop position for horizontal
canal DPRM.
Stop will engage with upper
hydraulic shock absorber during
horizontal canal DPRM.
Stop position for Sémont
and Epley maneuvers.
Stop will engage with lower
hydraulic shock absorber
during vertical canal DPRM.

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 9
When the electromagnetic lock is locked, the green indicator light is off.
To be able to change the position of the primary frame, the operator must
press the foot switch, after which the green light switches on and it is then
possible to move the chair on its axis.
Always keep a hand on the handles to secure the device and always use
the handles for the maneuvers.
WARNING
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 10
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 11
Key to picture on page 10:
A Secondary frame rotation axis
B Secondary frame lock - lockable every 45°
C Headrest forward travel locking screw
D Headrest locking system
E Handle for patient
F Manually sliding counterweight
G Leg strap
H Secondary frame
I Green light on when electromagnetic locking system of the primary frame is unlocked
J Headrest left temporal support locking screw
K Secondary frame and carrying handle
L Headrest upward and downward travel locking button
M Primary frame shock absorber for Sémont maneuvers
N Shoulder support
O Primary frame and carrying handle

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 12
Safety Release Mechanism
In case the battery should run out of power, the battery-powered lock for the main arm can be manually
released by pulling the handle knob away from the main arm, and it can be locked in the released position.

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 13
3Using the chair
3.1 Precautions for use – basic safety rules
Before seating a
patient, make sure that both axle locks are in their locked
positions
.
Always gently seat the patient in the chair. Do not let the patient fall into the
chair. It can result
in damaging or unbalancing the medical device and can
result in
the patient falling on the ground. Never release the primary frame
lock when there is no patient in the chair
.
Be aware that the worst mechanical position is secondary frame horizontal
with the
patient facing the primary frame. In this position, be careful that the
patient doesn’t
move excessively and do not apply strong shocks on the
medical device.
Whenever a position is selected following rotation of the secondary frame,
it is
important to check that the mechanical locking system is correctly
engaged. Before the primary frame is released, the patient should be
informed what type of movement to expect as well as of the probability of
vertigo during the maneuver. Throughout the va
rious maneuvers, it is
recommended that the operator keeps talking with the patient to provide
reassurance.
Never release both axles of rotation at the same time
.
The operator must never be alone in the room with the patient
when using
the chair. In case of inability
on behalf of the operator during a session, a
secondary operator
will have some instructions fixed to the wall to explain
how to free the patient
.
Always use the handles to manipulate the device. Failure to use the
handles during maneuvers
may incur pinch / trapping danger and potential
damages.
During maneuvers
, mind not to pull out the wire of the foot switch.
No one except the operator and the patient
may stand closer than 2 meters
from the chair
.
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 14
Even th
ough all the materials are skin-friendly, it is recommended to use
normal clothing covering arms, legs and feet during the examination.
There
might be a
minimal risk of skin reactions with bare skin in contact with the
safety harness, pads or s
traps.
Potential side effects:
•Patients presenting with moderate headache may experience a worsened condition after the
treatment.
•Patients presenting with nausea may be at risk of vomiting during the diagnostic and therapeutic
maneuvers. They must be requested to alert the operator as early as possible if they are about to
vomit so the operator can terminate the procedure, put the patient in the upright position, remove
the goggles and open the harness and leg strap. A container must be kept available to collect any
vomit.
Connection to other medical devices:
•The TRV chair is constructed for use with the IEE1394a FireWire™ Video Frenzel or VNG
systems from Interacoustics A/S. Eye images are recorded by means of infra-red video cameras
mounted on the goggles. A cable connection with two sets of slip-rings conducts the video signal
from the cameras, through the two axles, to a computer. The eye images are analyzed and
displayed on an external screen for optimal observation of nystagmus during the diagnostic and
therapeutic procedures.
Precautions to be taken in the event of changes in the performance of the device:
•The manufacturer should be advised of any change in the performance of the device. The device
should be taken out of use and not returned to use until the necessary corrective actions, as
specified by the manufacturer, have been carried out.
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 15
3.2 Seating the patient
Once the patient is seated, if the chair is only to be used for a conventional consultation in which only the
vertical axis is released, for example in order to examine one ear and then the other without the operator
needing to move, no supporting device is necessary.
If the patient is due to be diagnosed and treated for positional vertigo, supporting devices are essential
and should be placed as follows:
Adjust the headrest according to the height of the upper body by means of the release button.
Leave enough space above the eyebrows to allow the head strap to be tightened without interfering with
the VNG goggles.
Always unleash the headrest before the googles.
WARNING

D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 16
3.2.1 Fitting the harness:
To fit the harness, start with the abdominal strap; this should be placed as low as possible, below the
abdomen, at the root of the thighs, to immobilize the pelvis. Pull the strap as tight as possible.
The central buckle should remain in the middle and the strap adjusted alternately to the left and right to
keep it in that position. Maximum tightness can be obtained by pressing the strap with the flat of the hand
against the side of the pelvis, using the other hand to pull on the free end of the strap; do this on each
side in turn.
Next, the two shoulder straps are fitted and tightened by pulling the free end of the strap downwards to
ensure full patient support.