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D-0125111-A – 2020/04  

TRV chair – Instructions for Use - EN 

 

 

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 36

 

 

6.1  Electromagnetic Compatibility (EMC)  

This instrument is suitable in hospital environments except for near-active HF surgical equipment and 

RF-shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic 

disturbance is high. 

Use of this instrument adjacent to other equipment should be avoided because it could result in improper 

operation. If such use is necessary, this instrument and the other equipment should be observed to verify 

that they are operating normally. 

Use of accessories and cables other than those specified or provided by the manufacturer of this 

equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of 

this equipment and result in improper operation. The list of accessories and cables can be found in this 

appendix. 

Portable RF communications equipment (including peripherals such as antenna cables and external 

antennas) should be used no closer than 30 cm (12 inches) to any part of this instrument, including 

cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could 

occur. 

NOTICE ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as: 

This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL 

PERFORMANCE cannot lead to any unacceptable immediate risk. 

Final diagnosis shall always be based on clinical knowledge.  

This instrument complies with IEC60601-1-2:2014, emission class B group 1. 

NOTICE: There are no deviations from the collateral standard and allowances uses.  

NOTICE: All necessary instructions for maintenance comply with EMC and can be found in the general 

maintenance section in this instruction. No further steps required. 

 

 

Summary of Contents for TRV chair

Page 1: ...Instructions for Use EN TRV chair Science made smarter 8522633 D 0125111 A 2020 04...

Page 2: ......

Page 3: ...s 16 3 2 2 Placing the headrest 17 3 3 Emergency exit 19 3 4 Charging the battery 19 4 Diagnostic maneuvers protocol proposal 23 4 1 General 23 4 2 Characteristics of positional nystagmus 28 4 3 Thera...

Page 4: ......

Page 5: ...r 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 atypic...

Page 6: ...ith 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 pers...

Page 7: ...ipment 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 essentia...

Page 8: ...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 Ke...

Page 9: ...re 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 a...

Page 10: ...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 but...

Page 11: ...ular 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 ar...

Page 12: ...Repositioning Maneuvers DPRM also known as the TRV maneuver At 45 below the horizontal plane for S mont and Epley maneuvers to increase therapeutic efficacy Stop position for horizontal canal DPRM Sto...

Page 13: ...r 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 a...

Page 14: ...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...

Page 15: ...ystem 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...

Page 16: ...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...

Page 17: ...ck 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...

Page 18: ...gles 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 Vide...

Page 19: ...r 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...

Page 20: ...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 wi...

Page 21: ...the headrest so that the head strap leaves a space of approximately 2 cm above the eyebrows for the VNG goggles The VNG goggles should be fitted before adjusting the head strap The purpose of this str...

Page 22: ...frame are on the magnetic locking system will be released by a slight pull or push of the primary frame The vertical axle is released by pulling the lock button downwards It is automatically brought b...

Page 23: ...d if the patient cannot be release safely the operator can pull on a manual release system back of the column to free the shaft and put the patient upright 3 4 Charging the battery The TRV chair is eq...

Page 24: ...D 0125111 A 2020 04 TRV chair Instructions for Use EN Page 20 A B G I C D E F H J K L M N...

Page 25: ...S mont and accentuated Epley maneuver E Foot switch for the electromagnetic locking system primary frame F Carrying handle on the primary frame G Manual mechanical locking system to lock the secondary...

Page 26: ...D 0125111 A 2020 04 TRV chair Instructions for Use EN Page 22...

Page 27: ...ol proposal IMPORTANT Always check the supports before setting the chair in motion see green arrows below 4 1 General The primary frame must not be released until the patient is in the correct positio...

Page 28: ...the secondary frame is pointing in the direction of the intended movement Lock the vertical arm by releasing the lock knob Check that the lock engages fully and in the correct notch for the Dix Hallp...

Page 29: ...ob until the left handle on the secondary frame is pointing in the direction of the intended movement Lock the secondary frame by releasing the lock knob Verify that the lock engages fully and in the...

Page 30: ...tal position with the patient s left ear pointing to the floor Lock the primary frame in the horizontal position by means of the foot switch Observe that the magnetic lock engages correctly and that t...

Page 31: ...nature and characteristics of the horizontal positional nystagmus are sufficiently documented to determine which side needs treatment The examiner may refer to Ewald s 2nd law Paganni Mc Clure maneuv...

Page 32: ...e Sidelying Left Ear Down 60 seconds Left Torsional Upbeating Left Posterior Cupololithiasis Dix Hallpike Sidelying Left Ear Down 30 seconds Left Torsional Downbeating Right Anterior Canalithiasis Dix...

Page 33: ...complemented with rapid deceleration using a limit stop against a hydraulic shock absorber potentiated S mont maneuver It is essential to lock the system in the working position for the undermost shoc...

Page 34: ...rior canal up beating w torsional component towards affected ear After a pause of about one minute the potentiated S mont maneuver can be performed at 270 with brisk deceleration against the purpose d...

Page 35: ...is tilted backwards to put the patient in the side lying position with the involved ear towards the floor The first series of eight to twelve shocks is performed with the abutment moving against the...

Page 36: ...n the same way as in the Dix Hallpike maneuver except that it is extended until the patient s head is fully downwards This position is held for 30 seconds after which the patient is raised 45 in the o...

Page 37: ...ect the magnetic lock and cylinder Inspect all the chair nuts for tightness Inspect and test the four shock absorbers Inspect and test the electromagnetic lock Inspect and test the two manual locks In...

Page 38: ...f a fluid or conductive particle into the electrical components The use of sharp objects on the soft parts of the chair Loading and unloading without proper equipment In case of a warranty issue pleas...

Page 39: ...ndards Safety IEC 60601 1 2005 A1 2012 Type B applied parts EMC IEC 60601 1 2 2014 Dimensions Length 160 cm Width 120 cm Height 190 cm Weight 640 kg Operation conditions The chair should be used in an...

Page 40: ...in improper operation The list of accessories and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be...

Page 41: ...11 Class B The TRV is suitable for use in all commercial industrial business and residential environments Harmonic emissions IEC 61000 3 2 Complies Class A Category Voltage fluctuations flicker emiss...

Page 42: ...that of a typical commercial or residential environment Surge IEC 61000 4 5 1 kV Line to line 2 kV Line to ground 1 kV 2 kV Mains power quality should be that of a typical commercial or residential e...

Page 43: ...1 kHz 6 Vrms Radiated RF 3 V m 3 V m 80 MHz to 800 MHz IEC EN 61000 4 3 80 MHz to 2 7 GHz 80 AM at 1 kHz 800 MHz to 2 7 GHz Where P is the maximum output power rating of the transmitter in watts W acc...

Page 44: ...e observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the TRV b Over the frequency range 150 kHz to 80 MHz fi...

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