BMB Medical CLAVIA System Surgery Electric Transfer Bed V10 User Manual

Contents I.

PRESENTATION/SPECIFICATIONS ...1 1.1 PRODUCT PRESENTATION ...1 1.1.1 Multi-purpose stretcher chair for ambulatory care CLAVIA LSA ...1 1.1.2 CLAVIA FSP Multi-purpose care stretcher chair ...3 1.1.3 Chemotherapy and dialysis stretcher chair CLAVIA FCD ...5 1.1.4 Stretcher bed for one-day surgery CLAVIA LSA SURGERY ...7 1.2 PURPOSE OF THE HANDBOOK ...9 1.3 STORAGE ...9 1.4 SYMBOLS AND STANDARDS USED ...9 II. INSTRUCTIONS FOR USE...10 2.1 – BATTERY ...10 2.2 – REMOTE CONTROL ...11 2.3 – HEIGHT ADJUSTMENT AND LOWERING ...12 2.4 – BACKREST ...13 2.5 – LEG REST ...13 2.6 – FOOTREST (CLAVIA I-line FCD and FSP model)...14 2.7 – TRENDELENBURG POSITION ...14 2.8 – SIDERAILS ...14 2.8.1 CLAVIA and CLAVIA I-LINE LSA and FSP models ...15 2.8.2 CLAVIA LSA SURGERY MODEL ...16 2.9 – ARMRESTS ...17 2.10 – BRAKE AND STEERING PEDAL ...18 2.11 – HEADREST ...18 2.12 –HEADREST (CLAVIA LSA SURGERY) ...19 2.13 – SIDE TECHNICAL RAILS (CLAVIA LSA SURGERY) ...21 2.14 – OPTIONS...21 2.14.1 The directional 5th wheel...21 2.14.2 Collapsible push handles:...22 2.14.3 IV pole...23 2.14.4 Remote control holder ...23 2.14.5 Blood sampling trough, mounted on side technical rails (LSA and LSA surgery model) ...24 2.14.6 Paper roll dispenser ...24 2.14.7 Push handles under backrest (LSA model) ...24 2.14.8 Paediatric Kit (CLAVIA LSA) ...25 2.14.9 Accessory basket under the backrest (LSA model) ...26 2.14.10 Meal tray ...27 III. CLEANING AND DISINFECTING ...28 3.1 - INTRODUCTION ...28 3.2 - FREQUENCY ...28 3.3 – RECOMMENDED EQUIPMENT AND PRODUCTS ...28 3.4 – RECOMMENDATIONS FOR CLEANING AND DISINFECTION ...29 3.4.1 Cleaning process for the specific elements ...29 3.4.2 Rules to respect ...29 IV. PRECAUTIONS ...30 4.1 – PRECAUTIONS CONCERNING THIS DEVICE * ...30 4.1.1 Precautions related to the use of the stretcher chair ...30 4.1.2 Precautions related to equipment cleaning and maintenance ...30 4.2 – MISUSE ...31 4.3 – TRANSPORTATION AND STORAGE ...31 4.3.1 Transportation ...31 4.3.2 Storage ...32 4.4 – GUARANTEE ...32 4.5 – CUSTOMER SERVICE ...32 4.6 – ENVIRONMENTAL INFORMATION ...33 End-of-life Equipment ...33

___________________________________________________________________ The information in this document may be changed without notice and is not in any way binding on BMB MEDICAL. Any representation or reproduction, in whole or in part, without permission from BMB MEDICAL, is unlawful. Such unlawful representation or reproduction, by any means whatever, would constitute an infringement of copyright. The illustrations in this document are not contractual.

I.

PRESENTATION/SPECIFICATIONS

1.1 PRODUCT PRESENTATION The CLAVIA product line features an electrical height adjustment based on a parallelogram-shaped construction, whereas the CLAVIA I-Line features an electrical height adjustment based on columns.

1.1.1 Multi-purpose stretcher chair for ambulatory care CLAVIA LSA Technical specifications MODEL DESCRIPTION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS SIDERAILS TRENDELENBURG POSITION BACKREST

STANDARD FEATURES

OPTIONAL FEATURES

CLAVIA & CLAVIA I-LINE LSA Multi-purpose stretcher chair for ambulatory care CLAVIA LSA CLAVIA: 200 kg CLAVIA I-Line: 250 kg (max. load including total patient weight, mattress weight and accessories)

80 kg (CLAVIA I-Line 60), 85 kg (CLAVIA I-Line 70), 90 kg (CLAVIA ILine 80). 215 x 73, 83, 93 cm (bed position) / 155 x 73, 83, 93 cm (chair position) 110 x 28 cm (height above mattress) Electric 11° 0 - 90 ° - Electric – manual CPR function - Removable mattress made of high resilience foam (35 kg/m3), width 10 cm.* - Removable cover of PVC-coated Jersey fabric. - Electric height adjustment on columns: 55 - 90 cm (55 – 95 cm for CLAVIA I-Line). - Electric backrest adjustment with manual CPR. - Electric leg rest adjustment, LINAK actuators. Battery. - Digital actuators allowing the following programmed positions:  CLAVIA, 2 programmed positions: stretcher, chair.  CLAVIA I-Line, 4 programmed positions: stretcher, chair, CPR and bed position. - Epoxy-coated steel frame. - Frame protection cover. - 4 casters with central braking system Ø 125 mm incl. 2 directional ones. - Bumpers at every corner fitted with holder for accessories. - 2 holders for IV pole on the seat. - Push bars foot-end in one single part. - Double running wheels Ø 150 mm. - Double running wheels Ø 150 mm with anti-static system. - 5th wheel - Holder for remote control. - 2- stage removable IV pole, 2 hooks. - Retractable push bars head-end. - Push bars below backrest. - Sliding head-support. - Side technical rails. Only compatible with side rails with vertical bars - Armrest for blood sampling. - Paper roll dispenser head-end. - Accessory basket Under the backrest. Lockable. - Fixation clamp for armrest (on technical rails) - Mattress protection at foot end - High comfort Mattress. High-quality foam (35 kg/m3) + 2 cm viscoelastic layer, total width: 12 cm *

* BMB MEDICAL shall not under any circumstances be held liable for any problems arising if the mattress used does not match the mattress catalogue numbers recommended by BMB MEDICAL.

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– FIELD OF APPLICATION This multi-purpose stretcher chair is, according to its technical specifications, options and accessories, suitable for ambulatory care and surgery in a hospital.

Product overview CLAVIA I-Line LSA

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1.1.2 CLAVIA FSP Multi-purpose care stretcher chair Technical specifications MODEL DESCRIPTION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS FOLDABLE SIDERAILS TRENDELENBURG POSITION BACKREST

STANDARD FEATURES

OPTIONAL FEATURES

CLAVIA & CLAVIA I-line FSP CLAVIA FSP Multi-purpose care stretcher chair CLAVIA: 200 kg CLAVIA I-Line: 250 kg (max. load including total patient weight, mattress weight and accessories)

80 kg (CLAVIA I-Line 60), 85 kg (CLAVIA I-Line 70). 200 x 73, 83 cm (bed) / 145 x 73, 83 cm (chair) 110 x 28 cm (height above mattress) Electric 11° 0 - 90 ° - Electric – with manual CPR function - Fixed mattress made of high resilience foam (35 kg/m3), width 10 cm.* - Removable cover of PVC-coated Jersey fabric. - Adjustable headrest. - Electric height adjustment on columns: 55 - 90 cm (55 – 95 cm for CLAVIA I-Line). - Electric backrest adjustment with manual CPR. - Electric leg rest adjustment, LINAK actuators. Battery. - Digital actuators allowing the following programmed positions:  CLAVIA, 2 programmed positions: stretcher, chair.  CLAVIA I-Line, 4 programmed positions: stretcher, chair, CPR and bed position. - Epoxy-coated steel frame. - Frame protection cover. - 4 casters with central braking system Ø 125 mm incl. 2 directional ones. - Foldable side-guards. Length 110 x Height 28 cm above mattress. - 2 holders for IV pole on the seat. - Push bars. - Double running wheels Ø 150 mm. - Anti-static system - 5th wheel - Paper roll dispenser head-end. - Holder for remote control. - 2- stage, removable IV pole, 2 hooks. - Adjustable footrest. - Technical rails - Armrest for blood sampling. - Removable crystal protection for leg rest. - Removable crystal protection for footrest. - High comfort Mattress. High-quality foam (35 kg/m3) + 2 cm viscoelastic layer, total width: 12 cm *

* BMB MEDICAL shall not under any circumstances be held liable for any problems arising if the mattress used does not match the mattress catalogue numbers recommended by BMB MEDICAL.

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– FIELD OF APPLICATION This stretcher chair is, according to its technical specifications, options and accessories, suitable for ambulatory care in a hospital. It is used for patient admission, transport, recovery, post-anaesthesia, blood sampling and examination.

Product overview CLAVIA I-Line FSP

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1.1.3 Chemotherapy and dialysis stretcher chair CLAVIA FCD Technical specifications MODEL DESCRIPTION

CLAVIA & CLAVIA I-LINE FCD 60 and 70 (width in cm)

SAFE WORKING LOAD

CLAVIA: 200 kg CLAVIA I-Line: 250 kg (max. load including total patient weight, mattress weight and accessories)

WEIGHT OVERALL DIMENSIONS TRENDELENBURG POSITION BACKREST

80 kg (CLAVIA I-Line 60), 85 kg (CLAVIA I-Line 70).

Chemotherapy and dialysis stretcher chair

200 x 96 or 106 cm (bed) / 145 x 96 or 106 (chair) Electric 0 to 90° – Electric – with manual CPR function.

- Fixed mattress made of high-resilience foam (35 kg/m3), width 10 cm.* - Removable cover of PVC-coated Jersey fabric. - Adjustable headrest.

STANDARD FEATURES

OPTIONAL FEATURES

- Electric height adjustment on columns: 55 - 90 cm (55 – 95 cm for CLAVIA I-Line). - Electric backrest adjustment with manual CPR. - Electric leg rest adjustment: 0 - 60° - Digital actuators allowing the following programmed positions:  CLAVIA, 2 programmed positions: stretcher, chair.  CLAVIA I-Line, 4 programmed positions: stretcher, chair, CPR and bed position. - Epoxy-coated steel frame. - Frame protection cover. - 4 casters with central braking system Ø 125 mm incl. 2 directional ones. - Anatomic shaped armrest following the backrest inclination. Adjustable in all directions. Retractable behind the backrest for lateral patient transfer. - 2 holders for IV pole on the seat. - Castors Ø 125 mm with central brake - Double running wheels Ø 150 mm - Anti-static system - 5th wheel - Battery (50 cycles) - Foldable push bars head-end - Holder for remote control. - 2- stage, removable IV pole, 2 hooks. - 2 additional holders for accessory (IV pole, holder for remote control) - Paper roll dispenser - Electric adjustable footrest. - Removable crystal protection for leg rest. - Removable crystal protection for footrest. - High comfort Mattress. High-quality foam (35 kg/m3) + 2 cm viscoelastic layer, total width: 12 cm *

- FIELD OF APPLICATION This stretcher chair is, according to its technical specifications, options and accessories, suitable for chemotherapy and dialysis care.

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Product overview CLAVIA I-Line FCD

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1.1.4 Stretcher bed for one-day surgery CLAVIA LSA SURGERY Technical Specifications MODEL DESCRIPTION SAFE WORKING LOAD WEIGHT OVERALL DIMENSIONS FOLDABLE SIDERAILS TRENDELENBURG POSITION BACKREST

STANDARD FEATURES

OPTIONAL FEATURES

CLAVIA LSA SURGERY Stretcher bed for one-day surgery 200 kg (max. load including total patient weight, mattress weight and accessories) 110 kg (CLAVIA I-Line 70), 120 kg (CLAVIA I-Line 80). 215 x 83, 93 cm (bed) / 155 x 83 or 93 cm (chair) 100 x 25 cm (height above mattress) Electric 11°. 0 to 90° – Electric – with manual CPR Function - Removable mattress made of high resilience foam (35 kg/m3), width 10 cm.* - Removable cover of PVC-coated Jersey fabric. - 2 section backrest with a removable head section to fasten a surgery head rest for ophthalmology, stomatology and ENT. - Electric height adjustment on columns: 55 - 95 cm. - Electrically (LINAK) assisted Trendelenburg (11°). - Electric backrest adjustment with manual CPR. - Electrically (LINAK) assisted leg rest 0 - 60°. - Digital actuators allowing the following four programmed positions: stretcher, chair, CPR and bed position. - Epoxy-coated steel frame. - Frame protection cover. - 4 casters with central braking system Ø 125 mm incl. 2 directional ones. - Foldable 4 vertical bars side guards. Length 100 x Height 25 cm above mattress. - Bumpers on 2 corners at foot end fitted with holder for accessories. - Technical rails at both sides - 2 holders for IV pole on the seat. - Foldable push bars in 2 single parts at foot end. -

Double running wheels Ø 150 mm. Anti-static system 5th wheel Holder for remote control. Cable reel 2- stage, removable IV pole, 2 hooks. Removable surgery head rest for ophthalmology Removable surgery head rest for stomatology and ENT Head rest support. Fixation on technical rails. Fixation clamp for accessories (on technical rails) Fixation clamp with height adjustment for accessories (on technical rails) Holder for operating field, with connection for oxygen Armrest for blood sampling. 2 additional holders for accessory (IV pole, holder for remote control) Pivoting meal tray to be fixed on the right side or on left side of the chair I-Pad support High Comfort mattress, high quality foam (35 kg/m3) + 2 cm thick viscoelastic layer (total height: 12 cm)

* BMB MEDICAL shall not under any circumstances be held liable for any problems arising if the mattress used does not match the mattress catalogue numbers recommended by BMB MEDICAL.

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- FIELD OF APPLICATION This stretcher chair is, according to its technical specifications, options and accessories, suitable for ophthalmologic examinations and minor ophthalmic surgical procedures.

Overview CLAVIA LSA SURGERY

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1.2 PURPOSE OF THE HANDBOOK This handbook is intended for healthcare professionals, and aims to give them all the information required and the precautions to apply for completely autonomous and safe use. The instructions concerning product maintenance and tracking guarantee its long working life. It is therefore essential for this guide to be accessible to all personnel, so that they will be aware of the handling procedures and the risks involved in using this stretcher chair. The stretcher chair must be handled by a qualified person who is aware of the risks inherent in incorrect use.

1.3 STORAGE This handbook must be kept near the product, in a location especially designated for the purpose. It must be protected from any conditions or substance likely to compromise its perfect legibility.

1.4 SYMBOLS AND STANDARDS USED

Type B medical equipment Indicates that failure to apply the recommendation could place the patient or user in danger, or damage the equipment. Compliant with the essential requirements of Directive 93/42/EEC concerning medical devices.

IPx4

Protection against water splash and water spray.

Indicate the safe working load

This stretcher chair is a Class I non-invasive, active medical device.

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II.

INSTRUCTIONS FOR USE

2.1 – BATTERY The battery housing is equipped with its own charger. The battery should be kept in temperate environment for twelve hours before its first use. Then, charge the battery for twelve hours by connecting it to an AC power supply outlet. We strongly recommend keeping the chair connected to the AC power supply in case of stationary use. The battery, with limited battery life, maintains the stretcher chair in operation in the event of a power cut or during a transfer. The battery maintains the stretcher chair in operation in the event of a power cut, or allows the chair to continue operating when disconnected from the electrical power supply for a transfer. Once any handling operations are finished, however, it is essential to remember to reconnect the stretcher chair to the power supply, to maintain an acceptable charge level. Never allow the battery to become completely discharged (risk of reduced battery performance). When charged, the battery can last for 25 cycles (raising + lowering of a function). When the audible signal indicates that the battery is low, immediately connect the chair to the AC power supply. Conditions for connection to the electrical network and electromagnetic compatibility: - The connection to the electrical network must comply with the NF C 15-100 and NF C 15211 (230-V electrical outlet) standards. The network used must be protected by a 30-mA (maximum) differential circuit breaker. - Servicing of the electrical parts must be performed by qualified, authorised personnel. - Although the chair satisfies the EN 60-601-1-2 standard, it can cause non-negligible electromagnetic interference. In that case, we recommend inhibiting the functions of the chair and removing devices subject to disturbance to a sufficiently remote location.

Optional device: cable reel with remote control

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2.2 – REMOTE CONTROL -

CLAVIA I-Line Range a) Positions programmed for the CLAVIA I-Line Range

1

2

3

4

1) 2) 3) 4)

Patient reception chair Patient transport CPR (emergency position) Trendelenburg position

Do not activate the various positions until you have checked that nobody is touching the mechanical parts

b) Reset This function should be used when the chair no longer responds to the orders issued by the remote control. To reinitialise the controls: 1) Connect the product to an AC power supply outlet 2) Press the 'CPR' and 'Trendelenburg position' keys at the same time, and hold until the audible signal stops. 3) Long-press the 'height adjustment' key to raise the chair to its maximum height. 4) Long-press the 'backrest' key and raise the backrest of the chair to its maximum height. 5) Resume normal use of the remote control.

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-

CLAVIA Range a) Automatic Positions of the CLAVIA range

Bed position

Chair position

2.3 – HEIGHT ADJUSTMENT AND LOWERING Before using these features: - Ensure that no objects or people are under the patient surface.

Use the remote control to adjust the height:

Top position*

or

Bottom position*

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2.4 – BACKREST Before actuating the backrest, ensure that nothing is impeding its movement (accessories, cables, etc.) J

The backrest is controlled using the remote control:

or

*Model shown: CLAVIA Standard FSP

If you need to lower the backrest quickly, pull the red handle and guide the backrest by pulling it down.

CLAVIA I LINE Range

CLAVIA Range

If the manual emergency unlocking is used, lower the backrest is the lowest position with the remote control to reset its functioning.

2.5 – LEG REST Function actuated by the remote control:

Leg rest in bottom position*

or

Leg rest at mid-height*

Leg rest in raised position*

*Model shown: CLAVIA I-Line Ophthalmology

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2.6 – FOOTREST (CLAVIA I-line FCD and FSP model) To activate the footrest, use the remote control:

Do not use the footrest to climb on the product. . It is a comfort element for the patient.

2.7 – TRENDELENBURG POSITION Use the remote control for the Trendelenburg position:

or

Model shown : CLAVIA FSP

2.8 – SIDERAILS

The siderails are intended to reduce the risk of the patient accidentally falling. They are absolutely not designed to immobilise or hold the patient using immobilisation devices such as straps. Before handling the siderails, ensure that nothing is impeding their movement. Do not use the siderails for moving the product.

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2.8.1 CLAVIA and CLAVIA I-LINE LSA and FSP models Lowering the siderails: To unlock, hold the handle down and push the siderail .

 

Raising the siderails: 1) Hold the handle down and lift the siderail . 2) Locking is automatic.

 

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2.8.2 CLAVIA LSA SURGERY MODEL Lowering the siderails: To unlock, hold the handle down and push the siderail  sideways. For easier handling, we recommend keeping one hand on the handle and placing the other hand on the horizontal railing to guide the movement. If the handle is stiff, do not force it. Use the play in the siderail to move it slightly and unlock the handle.

 

Raising the siderails: 3) Grasp the horizontal railing and pull it up until the handle locks in position. You should hear a ‘clic’. Locking is automatic 

To avoid any risk of trapped fingers, do not grasp the handle. If you don’t hear the ‘click’, you must maintain the siderails.

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2.9 – ARMRESTS To lower or raise the armrests, press the paddle located under the armrests.

You can also adjust the height of the armrest (❶ & ❸). To put it down, pull the locking bolts and lift the armrest up in same time (❷).

To put it up, pull the armrest (❷). Don’t pull the locking bolts.

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2.10 – BRAKE AND STEERING PEDAL Always keep the chair brake pedal applied, except when transporting a patient. Check that the brake is active by trying to move the chair. Do not park the chair on a sloping floor. You can find the brake and steering pedals at the head end and on the sides. Refer to the general views. The brake and steering pedal at the head end provides three functions:  Chair locked- pedal down.  Chair in directional steering mode (facilitating movement in a straight line) – pedal up . (except for the option 5th wheel)  Free-steering chair (allowing multi-directional movement) – pedal in mid position.







Lateral brake and steering pedals:  Chair locked- red side down.  Chair in directional steering mode – green side down. (except for the option 5th wheel)  Free-steering chair – pedal in mid position (horizontal). 





2.11 – HEADREST The headrest is easily adjustable, thanks to its counterweight system located behind the backrest.

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