TIM, VELVET and SWANN Relaxation and Rest Chairs User Manual May 2022

TABLE DES MATIERES FRANÇAIS ... 2 1 INTRODUCTION SPECIFICATIONS ... 5 1.1 PRESENTATION DU PRODUIT ... 5

2

1.1.1

FAUTEUIL DE SOINS POLYVALENT HAUTEUR FIXE TIM ... 6

1.1.2

FAUTEUIL DE SOINS POLYVALENT HAUTEUR FIXE VELVET ... 7

1.1.3

FAUTEUIL DE SOINS POLYVALENT HAUTEUR FIXE SWANN ... 8

1.2

OBJECTIF DU MANUEL D’UTILISATION ... 9

1.3

UTILISATEURS ... 9

1.4

CONSERVATION ... 9

1.5

PARTIES APPLIQUEES ... 9

1.6

SYMBOLES ET NORMES UTILISES... 10

MODE D’EMPLOI... 12 2.1 CONDITIONS D’UTILISATION ... 12 2.2

PROCEDURE D’INSTALLATION ... 12

2.3

BATTERIE (OPTION) & CONNEXION AU RESEAU ELECTRIQUE ... 12

2.4

TELECOMMANDE (VELVET & SWANN) ... 14

2.5

POSITIONS PROGRAMMEES ... 15

2.5.1

DECLIVE ... 15

2.5.2

HAUTEUR VARIABLE (option) ... 15

2.6

RELEVE-BUSTE & REVELE-JAMBE ... 16

2.6.1

RELEVE-BUSTE & REVELE-JAMBE À RÉGLAGE SYNCHRONISÉ (TIM) ... 16

2.6.2

RELEVE-BUSTE MANUEL (TIM) ... 16

2.6.3

RELEVE-BUSTE ELECTRIQUE (VELVET & SWANN) ... 17

2.6.4

RELEVE-JAMBES ELECTRIQUE (VELVET & SWANN)... 17

2.7

TÊTIERE PIVOTANTE ... 17

2.8

FREIN ET GUIDAGE ... 18

2.8.1

FREINAGE INDEPENDANT ... 18

2.8.2

FREINAGE CENTRALISE ET GUIDAGE LATERAL (OPTION) ... 18

2.9

ACCOUDOIRS ... 19

2.9.1

ACCOUDOIRS CONFORTS AMOVIBLES ... 19

2.9.2

ACCOUDOIRS ALUMINIUM FIXE ... 19

2.9.3

ACCOUDOIRS ESCAMOTABLES ... 19

2.10 OPTIONS ... 20 2.10.1

TIGE PORTE SERUM ... 20

2.10.2

SUPPORT ROULEAU PAPIER... 20

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3

4

2.10.3

LAMPE DE LECTURE + PORT USB... 21

2.10.4

COUSSIN CYLINDRIQUE DE CALAGE DE LA NUQUE ... 21

2.10.5

TABLETTE REPAS ... 21

2.10.6

GOUTTIERE POUR PRELEVEMENT ... 22

2.10.7

BARRES DE POUSSEE... 22

2.10.8

PIETEMENT SOCLE INOX ... 22

2.10.9

PROTECTION CRYSTAL AMOVIBLE ... 23

2.10.10

OPTION RELEVEUR ... 23

NETTOYAGE ET DESINFECTION ... 25 3.1 INTRODUCTION ... 25 3.2

PERIODICITE... 25

3.3

CONSEILS DE NETTOYAGE ET DE DESINFECTION ... 25

3.3.1

OPERATION DE NETTOYAGE ... 25

3.3.2

MATERIEL ET PRODUITS RECOMMANDES ... 26

PRECAUTIONS ... 28 4.1 PRECAUTIONS RELATIVES A CE DISPOSITIF ... 28 4.1.1

AVERTISSEMENTS... 28

4.1.2

CONTRE-INDICATIONS... 30

4.1.3

PRECAUTION LIEE A L’ENTRETIEN ET LE MAINTIEN EN L’ETAT DU MATERIEL ... 30

4.1.4

INFORMATIONS RELATIVES A LA CEM... 30

4.2

TRANSPORT ET STOCKAGE ... 32

4.2.1

TRANSPORT ... 32

4.2.2

STOCKAGE ... 32

4.3

GARANTIE ... 33

4.4

SERVICE APRES VENTE ... 34

4.5

ENVIRONNEMENT ... 34

4.5.1

MATERIEL USAGE ... 34

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ENGLISH BMB MEDICAL 100 Avenue du Formans CS 11001 01604 TRÉVOUX CEDEX Tel.: +33(0)4 74 08 71 71 Fax: +33(0)4 74 08 71 72 www.bmb-medical.com

The purpose of this manual is to familiarize you with the use, maintenance and safety of your new medical device. We encourage you to read this document carefully and to follow the guidelines for optimum and safe use.

BMB MEDICAL offers a broad variety of options for the products covered by this user manual. Consequently, some features described in this manual may not apply to your chair.

Some illustrations are provided for information purposes and do not accurately represent the device in your possession.

Stick the Product reference label here

The information in this document are subject to change without notice and in no way engage the responsibility of BMB MEDICAL. This document may not be reproduced, in whole or in part, without prior written consent by BMB MEDICAL. This illicit representation or reproduction, by any means, constitutes counterfeiting. The illustrations in this document are not binding.

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TABLE OF CONTENTS ENGLISH ... 36 1 INTRODUCTION SPECIFICATIONS ... 39 1.1 PRODUCT PRESENTATION ... 39

2

1.1.1

TIM VERSATILE FIXED-HEIGHT CARE CHAIR ... 40

1.1.2

VELVET VERSATILE FIXED-HEIGHT CARE CHAIR ... 41

1.1.3

SWANN VERSATILE FIXED-HEIGHT CARE CHAIR ... 42

1.2

PURPOSE OF THE USER MANUAL ... 43

1.3

USERS ... 43

1.4

STORAGE ... 43

1.5

APPLIED PARTS ... 43

1.6

SYMBOLS AND STANDARDS USED ... 44

INSTRUCTIONS FOR USE ... 46 2.1 OPERATING CONDITIONS... 46 2.2

INSTALLATION PROCEDURE ... 46

2.3

BATTERY (OPTIONAL) & CONNECTION TO MAINS POWER ... 46

2.4

REMOTE CONTROL ... 48

2.5

PROGRAMMED POSITIONS... 48

2.5.1

TRENDELENBURG POSITION ... 48

2.5.2

VARIABLE HEIGHT (optional) ... 49

2.6

BACKREST & LEGREST ... 49

2.6.1

SYNCHRONIZED ADJUSTMENT OF BACKREST & LEGREST (TIM) ... 49

2.6.2

MANUAL BACKREST (TIM) ... 50

2.6.3

ELECTRIC BACKREST (VELVET& SWANN) ... 50

2.6.4

ELECTRIC LEGREST ... 50

2.7

PIVOTING HEADREST ... 51

2.8

BRAKE AND GUIDE PEDAL ... 51

2.8.1 2.9

CENTRAL BRAKING AND SIDE GUIDES (OPTIONAL)... 52

ARMRESTS ... 52

2.9.1

REMOVABLE COMFORT ARMRESTS... 52

2.9.2

FIXED ALUMINUM ARMRESTS... 52

2.9.3

RETRACTABLE ARMRESTS ... 53

2.10 OPTIONS ... 53 2.10.1

IV POLE ... 53

2.10.2

PAPER ROLL HOLDER ... 54

2.10.3

READING LAMP + USB PORT ... 54

2.10.4

ANATOMICAL ARMREST FOR SAMPLING ... 54

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3

4

2.10.5

CYLINDRICAL NECK CUSHION ... 55

2.10.6

MEAL TRAY ... 55

2.10.7

PUSH BARS ... 55

2.10.8

STAINLESS STEEL BASE... 55

2.10.9

CRYSTAL PROTECTION ... 56

2.10.10

LIFTER OPTION ... 56

CLEANING AND DISINFECTION ... 58 3.1 INTRODUCTION ... 58 3.2

FREQUENCY ... 58

3.3

CLEANING AND DISINFECTION ADVICE ... 58

3.3.1

CLEANING OPERATION ... 58

3.3.2

RECOMMENDED EQUIPMENT AND PRODUCTS ... 59

PRECAUTIONS ... 60 4.1 DEVICE-RELATED PRECAUTIONS ... 60 4.1.1

WARNINGS ... 60

4.1.2

CONTRAINDICATIONS ... 61

4.1.3

PRECAUTION ASSOCIATED WITH EQUIPMENT CARE AND MAINTENANCE ... 61

4.1.4

EMC-RELATED INFORMATION ... 62

4.2

TRANSPORT AND STORAGE ... 64

4.2.1

TRANSPORT ... 64

4.2.2

STORAGE ... 64

4.3

WARRANTY ... 64

4.4

AFTER-SALES SERVICE ... 66

4.5

ENVIRONMENT ... 66

4.5.1

SPENT EQUIPMENT ... 66

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1 INTRODUCTION SPECIFICATIONS 1.1 PRODUCT PRESENTATION This patient support device consists of a backrest and seat fitted onto a chassis with wheels. The device is equipped with armrests and, optionally, allows the temporary fitting of IV poles. The device allows an operator to convey the patient within a healthcare establishment. The chair is braked by a mechanical system actuated by pressing a pedal. The device is equipped with an electrically assisted actuator system actuated by a remote control to manage the movements of the following elements: - backrest, - legrest, - electrical column used to adjust the product’s height. The products are designed to ensure that there are no unacceptable risks (essential performance) associated with patient support or caused by accidental movements.

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1.1.1

TIM VERSATILE FIXED-HEIGHT CARE CHAIR

TECHNICAL DATA REFERENCE DESIGNATION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS

EQUIPMENT

AVAILABLE OPTIONS

TIM TIM MANUAL RELAXATION AND REST CHAIR 130 kg (indicates the maximum admissible load including the total weight of the patient and accessories) 35 kg depending on the model Width: 73 cm Seat width: 57 cm Overall length: from 85 cm in sitting position to 153 cm in reclined position. Overall height: 115 cm. * Assisted synchronized backrest and legrest until the confort position (Gas assist cylinder) * The backrest goes independently of the legrest until the recovery position * Reinforced steel frame * Rack adjustment headrest * Seat on coil springs * Removable comfort armrests * Front exit * Retractable footrest under the seat * Tubular frame : - Front: 2 adjustable support pads - Back : 2 casters (Ø50 mm) * Seat and back cushions in HR 35 Kg density foam, fireproof, and covered * VALENCIA color range: M2 fireproof coating, 10 colors Reading lamp + USB Port Fixed aluminium armrests 4 self lockable casters (Ø50 mm) Inox base Ø 690mm Star base : 3 back casters + 2 front fixed pads Neck cylindrical cushion Legrest crystal protection

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1.1.2

VELVET VERSATILE FIXED-HEIGHT CARE CHAIR

TECHNICAL DATA REFERENCE DESIGNATION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS

EQUIPMENT

AVAILABLE OPTIONS

VELVET VELVET ELECTRIC CHAIR 160 kg (indicates the maximum admissible load including the total weight of the patient and accessories) 40 kg depending on the model Width (with ALU armrests) : 82 cm Width (with comfort armrests) : 74 cm Seat width: 57 cm. Overall length: from 100 cm in sitting position to 177 cm in reclined position. Overall height: 125 cm. Electric independant backrest and legrest (Electric cylinder) Reinforced steel frame, epoxy coated Rack adjustment headrest Seat on coil springs Foamed fireproof M1 vinyl, with silicone dacron Armrests with 7 cm HR foam padding and memory foam Front exit Retractable footrest under the seat Fixed height Star base with self lockable casters ø 75 mm Remote control holder Seat and back cushions in HR 35 Kg density foam, fireproof VALENCIA color range: M2 fireproof coating, 10 colors * Emergency electric recovery position on remote control * Reading lamp + USB Port * Bilateral holder for IV Pole (incompatible FA022) * Paper roll dispenser * Removable aluminium armrests 2 positions * Removable comfort armrests - incompatible with FA018V-G/D * Neck cylindrical cushion * Small Shelf : 42 x 32 cm (FA018V-D or FA018V-G necessary) * Large Shelf : 81 x 41 cm (FA018V-D or FA018V-G necessary) * Support for meal tray on the right side of the patient (compatible with the FA018V-G) * Support for meal tray on the right side of the patient (compatible with the FA018V-D) * 4 self lockable casters (Ø50 mm) * 2 back casters + 2 front fixed pads * Inox base Ø 690mm * Legrest crystal protection * Removable IV pole, 2-stage, 2 hooks (FA0088VE mandatory) * Removable IV pole, 2-stage, 4 hooks (FA0088VE mandatory)

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1.1.3

SWANN VERSATILE FIXED-HEIGHT CARE CHAIR

TECHNICAL DATA REFERENCE DESIGNATION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS

EQUIPMENT

AVAILABLE OPTIONS

SWANN SWANN ELECTRIC CHAIR 160 kg (indicates the maximum admissible load including the total weight of the patient and accessories) 80 kg depending on the model Width: 80 cm Seat width: 57 cm. Overall length: from 104 cm in sitting position to 183 cm in reclined position. Overall height: 131 cm. Fixed height tubular frame 2 pivoting self lockable back casters ø 125 mm 2 fixed front casters ø 125 mm Emergency electric recovery position on the remote control Aluminium armrest Rack adjustment headrest 2 holders for IV pole Electric backrest and legrest (Electric cylinders) Push bar PVC coated jersey VALENCIA color range: M2 fireproof coating, 10 colors * Reading lamp + USB Port * IV Pole * Battery * Paper roll dispenser * Phlebotomy armrest - Dimensions 400/200/40 mm (FA012S + FA015 or FA015B required) * Support for Phlebotomy armrest- The pair (FA015 or FA015B required) * Electric height adjustment (Electric cylinders) * Variable height with lift (Electric cylinders) * Two-sided foot pedals for Trendelenburg adjustment (Electric height adjustment necessary FA014) * Retractable armrests 3 positions (FA014 necessary) * Retractable aluminium armrests 2 positions * Small Shelf : 42 x 32 cm (FA018S-D or FA018S-G necessary) * Large Shelf : 81 x 41 cm (FA018S-D or FA018S-G necessary) * Support for meal tray on the right side of the patient (compatible with the FA018S-G) * Support for meal tray on the right side of the patient (compatible with the FA018S-D) * Back double running castors Ø 150 mm with central lock. * 2 pivoting self lockable front casters ø 100 mm * Beam of light * Neck cylindrical cushion * Removable legrest crystal protection

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1.2 PURPOSE OF THE USER MANUAL Healthcare professionals, this user manual was created for you to provide you with the necessary information and precautions to observe for autonomous and safe use. The product’s service life is dependent upon observance of the maintenance and tracking instructions. It is thus essential that all staff has access to and be informed of the handling procedures and risks associated with the use of this chair. The latter should be handled by a qualified person who is aware of the risks inherent to improper use. Additional training is not required as we consider that knowledge of the user manual is sufficient.

1.3 USERS Healthcare professionals: physicians, caregivers and agents approved by Technical Services can operate all functions. In use cases where the patient is the operator, the caregivers must first ascertain the patient’s ability to use the product. The caregivers must also teach the patient how to safely use the product: adjustment to low position to step off the product.

1.4 STORAGE This user manual should be kept near the product, in a place provided for this purpose. It must be shielded from all elements and substance that could compromise its perfect legibility.

1.5 APPLIED PARTS The applied parts, according to the EN 60601-1 standard, are as follows: - upholstery - armrests - remote control - reading lamp

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1.6 SYMBOLS AND STANDARDS USED Type B appliance Electrical class II equipment Electrical hazard, do not open

IPX4

Duty cycle (motor cycle) 2 min. operation / 18 min. stop Splash-resistant See the manual / instruction brochure Indicates the maximum permissible load, including the total weight of the patient, mattress (where applicable) and accessories. Conforms to the essential requirements of directive 93/42/EEC on medical devices. Serial number

REF

Product reference Manufacture date Manufacturer Alternating current Electronic waste: this symbol indicates that the product must not be discarded with unsorted municipal waste, but rather to a selective waste collection channel. Contact the local distributor for information concerning the return and/or collection systems available in the country. Protéger de l’humidité / keep dry Haut, tenir debout / stand up Fragile / fragile Recyclable / recycling Temperature range Humidity limit

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General safety sign: -

Information highlighted by this symbol must be read and scrupulously observed. Indicates that failure to observe the guideline could endanger the patient or user, or damage the equipment. Sitting on the backrest is prohibited Sitting on the legrest is prohibited Sitting on the armrests is prohibited

Leaning against the chair is prohibited The chair must be set to its low position before being moved

“WARNING: This appliance must not be altered without the manufacturer’s written consent.” Caution: only purpose-built accessories provided for this MD by BMB MEDICAL may be used. The TIM is a Class I non-invasive and non-active medical device. The VELVET is a Class I non-invasive and active medical device. The SWANN is a Class I non-invasive and active medical device.

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2 INSTRUCTIONS FOR USE 2.1 OPERATING CONDITIONS AMBIENT CONDITIONS Ambient temperature Relative humidity Atmospheric pressure

OPERATION +5 °C to +40 °C 20 to 90% at 30 °C - no condensation 700 to 1060 ha

2.2 INSTALLATION PROCEDURE Before commissioning the chair and depending on the model, check that the following are operational: -

Remote control Variable height Backrest Legrest Armrests Brake and guide pedals

Clean the product according to your establishment’s internal protocol.

2.3 BATTERY (OPTIONAL) & CONNECTION TO MAINS POWER The electronic unit is equipped with its own charger (the battery is charged with the chair cable). Before initial use, leave the product to stand for 12 h in a temperate environment (to allow the electrical and electronic components to reach normal operating temperature), then charge the battery for 12 hours from a mains outlet. In routine use, we strongly recommend keeping the chair plugged into the mains during sedentary use. The battery, with its limited operating life, can be used to operate the chair in the event of a power outage, or during transfer. Once the manipulations are complete, remember to re-connect the chair to the mains (at least 12 hours per day). Never allow the battery to drain fully (risk of reduced battery performance).

“Warning: Do not short-circuit the batteries and do not leave the system unused and without charging for extensive periods of time as this could cause self-discharge, leading to mediumterm damage. This will also have an environmental impact. »

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Battery characteristics

Battery safety symbols

Battery type: Capacity:

Lead gel 1.2 Ah

Input supply voltage:

24 VDC, 1.2 A

IPX6

Protection rating CE marking Indoor use Electronic waste

Power grid connection conditions and electromagnetic compatibility: This medical device’s power cord may represent an obstacle that could cause a fall. Be mindful of its presence when moving around the appliance, when the latter is connected to the mains. Position the chair such that it can be easily unplugged. Unplug the product before moving it. Do not leave the cables in contact with the floor or the casters, Do not knot the cables, Periodically check the condition of the cables. Mains connection: Frequency: Rated current: Protection rating / degree of electric shock protection: Power input:

220 V 50 Hz 3.5 A Class 2 appliance

770 W 10%, i.e. 2 minutes of continuous operation Intermittent operating mode: followed by 18 minutes of rest. The mains plug is the electrical grid insulation device. Work on electrical parts should only be performed by qualified and authorized staff. Electromagnetic interference caused by the chair cannot be excluded. In this case, the chair’s functions should be inhibited and those instruments subject to interference should be moved away. You can view the EMC information here.

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2.4 REMOTE CONTROL When using the remote control, all movements can be interrupted by simply releasing the corresponding key. Only activate the various positions after having ensured that no-one is touching any mechanical parts and that there are no objects under the seat, or between any of the moving structures.

VELVET

SWANN

SWANN with Variable height with lift

2.5 PROGRAMMED POSITIONS Sitting position

2.5.1

Reclining position

TRENDELENBURG POSITION

The Trendelenburg position is obtained by a long press on

2.5.1.1

BILATERAL TRENDELENBURG FOOT PEDAL (OPTIONAL)

Before activating Trendelenburg, check that nothing hinders the movement (accessories, cables, etc.) Press the blue pedal to move to the Trendelenburg position.

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2.5.2

VARIABLE HEIGHT (optional)

Before using these functions, ensure that there are no objects or persons under the patient surface. Height is adjusted using the remote control:

2.6 BACKREST & LEGREST

Before actuating the legrest and backrest, check that there are no obstacles to their movement (accessories, cables, etc.)

2.6.1

SYNCHRONIZED ADJUSTMENT OF BACKREST & LEGREST (TIM)

 The transition from patient installation position to the comfort position is done by gravitydriven by leaning back and pushing on the armrests.  Transition from the comfort position to the patient installation position is done by moving the legs to fold the leg rest under the seat.





Patient installation position

Comfort position

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2.6.2

MANUAL BACKREST (TIM)

The backrest is adjusted by tilting the torso back and pushing on the armrests.

2.6.3

ELECTRIC BACKREST (VELVET& SWANN)

Before actuating the backrest, ensure that there are no obstacles to its movement (accessories, cables, etc.) The backrest is adjusted with the remote control:

2.6.4

ELECTRIC LEGREST

Before actuating the legrest, ensure that there are no obstacles to its movement (accessories, cables, etc.) The legrest is controlled using the remote control:

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2.7 PIVOTING HEADREST The position of the headrest is adjusted manually: Pull the headrest forwards to tilt it. To tilt it backwards, move it forwards, then backwards.





2.8 BRAKE AND GUIDE PEDAL Except during transport, always ensure that the chair's brake Check whether the brake is engaged by attempting to move the chair.

is

engaged.

Do not park the chair on a sloping floor.

Star base on casters with independent brakes

Wheel in locked position

Tubular base 2 casters with independent brakes + 2 front glides

Wheel in free position

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To move the TIM: manually unfold the legrest and disengage the rear wheel brakes. The wheels are free.

2.8.1

CENTRAL BRAKING AND SIDE GUIDES (OPTIONAL)

Except during transport, always ensure that the chair's brake is engaged. Check whether the brake is engaged by attempting to move the chair. Do not park the chair on a sloping floor. Brake and side guide pedals: -

Brake engaged - red side lowered. Chair in directional guidance mode - green side lowered. Chair in free guidance mode - pedal in median position. 





2.9 ARMRESTS

2.9.1

REMOVABLE COMFORT ARMRESTS

2.9.2

FIXED ALUMINUM ARMRESTS

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