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

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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.

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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

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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

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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

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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:

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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).