Made In France - medimec.it · The emergency lowering function allows the Shado ® E to be swiftly lowered in case the patient needs to be transferred out of the trolley or if control

DOMA019EN v8_10-2015– Shado® User Manual Page 1 / 24

Shado ®

Shower Trolley

Made In France

User Manual


General Information

This user manual contains important safety instruct ions and information regarding installing, using and servicing the Sha do shower trolley

Please read carefully this manual and refer to the sections of the manual relating to

your own SHADO Shower Trolley. Options and features may vary depending on the mode l (160, 180, 200, 240, 350) and

options (centralized or independent brakes, hand re mote, size of the tray …)

This user manual applies to all SHADO shower trolle y range. For a safe and comfortable use of the device, pleas e read carefully the sections relating to your model.

Explanation of symbols used in this manual:

This symbol is used to point out instructions and i nformation related to safety where injuries may occur if the information is disr egarded or ignored. Follow these instructions and be careful and attent ive at all times.

This symbol indicates important information regardi ng the use of the equipment. If not taken into consideration, it may lead to dam ages or functional defects to the lifter or other equipments.

This symbol indicates important and useful informat ion. If taken into consideration, it will help the opera tor of the lifter to work efficiently. It may help simplify routines and explain complicat ed facts.

This manual is dedicated to the users of the Shado shower trolley and is protected by copyright. It should not be handed over, or made available to, any unauthorised third party, without a prior written consent from SCALEO Medical.


Content

About the Shado ® shower trolley range ........................................................................... 4

Warnings and safety notes ............................................................................................... 5

Head and foot rail mounting ............................................................................................. 6

Identifuying the parts of the Shado(r) trolley .................................................................. 7

Using the Shado ® shower trolley ..................................................................................... 9

Brakes and directional lock castors ........................................................................ 9

Safety features of the electric models ................................................................ 10

Charging and discharging the battery .................................................................. 10

Raising and lowering the tray ............................................................................... 12

Slope command ................................................................................................... 13

Handheld remote control...................................................................................... 13

Opening and closing the side rails ....................................................................... 14

Taking care of the patient .................................................................................... 15

Servicing, periodical inspection and preventive mai ntenance .................................... 17

Technical specifications ................................................................................................ 20

Terms of Warranty ........................................................................................................... 22

Liability ............................................................................................................................ 22

Disposal ........................................................................................................................... 22

EC Declaration of Conformity ......................................................................................... 23

How to contact us ........................................................................................................... 24


About the Shado shower trolley range

You have recently purchased a Shado ® shower trolley. We would like to thank you for the trust you have p laced in our company.

The Shado® shower trolleys are made for cleaning dependent or bedridden patients. They combine comfort and safety for both the patient and the caregiver. SCALEO Medical offers a complete range of shower tr olleys, with five maximum safety loads available : 160kg, 180 kg, 200 kg, 240kg, 350 kg. The model name states the maximum safety load. 160kg, 180kg and 200kg are available in hydraulic « H » and electric « E » versions. 240 and 350 are only available with electric actuators. Each model has been developed for specific needs an d offers many user friendly options:

- Shado® 160 is designed for children and small people, and can be used in small rooms, due to its extra short tray and mattress.

- The Shado® 180 models are the "standard" range, designed to deal with most situations. The Shado® 180 shower trolley is available in three sizes: adult, medium, and child and has many opportunities for equipment: stainless steel tray, hand held remote control for the electric models, centralized or independent wheel brakes…

- The Shado® 200 has a wide tray for the care of patients with particular pathologies not allowing the use of standard width shower trolleys.

- The Shado® 240 and 350 are designed for bariatric care and use a reinforced structure. All Shado ® shower trolleys are manufactured and tested in our workshops in France, under ISO 9001 and ISO 13485 certified quality management system. Using SCALEO Medical Shado® shower trolleys gives insure using products with guarantees of safety and quality. For more details on available equipments depending on models, please refer to the technical specifications of different models in the "Technical specifications" section of this manual. The device comes in a cardboard pallet containing:

• 1 shower trolley • 1 hemicylindrical (standard) or triangular (on demand) headrest, as selected

when ordering. The dimensions of the headrest are tailored to the mattress. • 1 User Manual • 1 battery and a charger for the electric models • 1 spare battery (optional for the electric models) • 1 wall charger (optional for the electric models) • 1 remote control (optional for the electric models)


Warnings and safety notes

Packaging elements (plastic, polystyrene wrappings etc.) must not be left within reach of children as they can be potentially harmfu l.

Do not put hands or fingers anywhere close to the s tructure or the chassis of the Shado ® during while using the height adjustment mechanism .

The following actions should be banned because that can cause serious injury to patient and/or the user:

• Failure to meet the recommendations for installatio n and use of this manual, • Failure to meet the recommendations for care and ma intenance of this manual.

• Using the Shado ® E while the “low battery” alarm is heard. • Trying to connect the Shado ® E to an incompatible electric plug or voltage

source • Using the Shado without prior explanation by a pati ent or anyone else or by a

child. • Using the Shado ® with a patient weighting more than the maximum loa d

capacity. • Using the Shado ® outdoors.

• Using the Shado ® on a slope, with or without a patient on it. • Moving the Shado ® on a non clear surface or carpeted floor.

• Plugging non standard electrical components, modify ing the electrical components, using spare parts other than original S CALEO Medical spare parts,

• Cleaning the shower trolley with a hose or with pre ssurised water.

• Manipulating the shower trolley by the railings, th e tray or by any other element that is not made for manipulations.

• Using a torn or damaged mattress.

Overall Failure to follow installation, operation, maintenance, preventive maintenance of the device as described in this manu al or under good care practices and hygiene

In the case of a mechanical or electrical problem, please contact SCALEO Medical who will either deal with your problem dire ctly or will communicate it to the closest authorized dealer. In all cases, you should ask for original spare par ts.

The trolley is designed t be used at room temperature, +10 to +40 °C. This should be taken into consideration when transporting the trolley, and therefore keeping it in a temperate part of the vehicle. Alternatively, the trolley must rest in a

Safety devices must never be taken out or modified. The Shado ® shower trolley should only be used once those devi ces are in place and in good working order.


temperate room until the equipment has achieved proper working temperature.

Head rail and foot rail mounting Unpacking Unpack the parcel with the usual care, Take off the trolley from the parcel after having unlocked the brake pedals.

One N°5 Allen wrench and one 13mm flat wrench (not provided) are necessary.

Head rail mounting Screw off the 4 locking nuts from the screws. Adjust the head rail and tighten the 4 screws until the rail is completely blocked.

Please pay attention to the command cable during this assembly: do not pinch it or catch it under the rail.

Foot rail mounting With the help of the fixing bolts, secure the foot rail and the draining hose holder hook to the stretcher.

Head Rail

Locking nuts

Foot rail Locking nuts

Draining hose holder hook

Locking nuts


Identifying the parts of a Shado ®

Hydraulic « H » versions

The picture above is only intended to show and name the main parts. For maintenance purposes detailed drawings and spar e parts list are available on demand or in our website for registered customers.

Rep. Description Nb.

1 PVC Mattress 1

2 Side rail 2

3 Side rails unlocking handle 4

4 Stretcher tilting control 1

5 Foot rail 1

6a Head rail mount locking nuts 4

6b Foot rail mount locking nuts 4

7 Draining plug 1

8 Draining hose 1

9 Trendelenburg position jack (slope actuator) 1

12 Stretcher raising jack (actuator) 1

13 Stretcher raising pedals 2

14 Pedals for multifunctional wheels (centralized brakes versions)

4

15 Castors (single or double tired depending on the model) 4

2 1 5 4

9

14

15

7 6a

8

12

13

3 3

6b


Electric « E » versions

The picture above is only intended to show and name the main parts. For maintenance purposes detailed drawings and spar e parts list are available on demand or in our website for registered customers.

Rep. Désignation Nb.

1 PVC Mattress 1

2 Side rail 2

3 Side rails unlocking handle 4

4 Stretcher tilting control 1

5 Foot rail 1

6a Head rail mount locking nuts 4

6b Foot rail mount locking nuts 4

7 Draining plug 1

8 Draining hose 1

9 Slope actuator 1

10 Emergency stop button 1

11 Control and power pack (battery) 1

12 Stretcher raising jack ( actuator) 1

13 Stretcher raising pedals 2

14 Pedals for multifunctional wheels 4

15 Castors (single or double tired depending on the model) 4

2 1 5 4

9

11

14

15

7 6a

8

10

12

13

3 3

6b


Using the Shado ® trolley

In order to use the Shado ® shower trolley safely, please carefully follow the instructions below. Please refer to the sections relating to the model you use. You can also contact SCALEO Medical or your local d istributor for further information.

Brakes and directional lock castors. Centralized brakes versions

Possible position of the brake pedals are:

� Press on 1 (YELLOW dot position): blocked direction � Press on 2 (RED dot position): brakes on � Horizontal position (GREEN dot position): free wheel

Pressing the pedal release the two corresponding castors (front or rear) Independant brakes Each wheel can be locked independently: directional blocking and rolling.

1

2

Brake lever up: freewheel Press the brake lever down: the wheel is blocked


Security features of the electric models Emergency stop and lowering According to European standards all SCALEO Medical devices have a RED emergency stop button which cuts the power off when set in the “ON “ position. To stop all the functions: simply press on the red button until it is lowered. To put the functions back on: turn the button clockwise until it is raised again. The emergency lowering function allows the Shado® E to be swiftly lowered in case the patient needs to be transferred out of the trolley or if control box is failing. With a ball-point pen press strongly on the button marked "Emergency" to make the tray go down.

Be sure that your hand remains out of the way of th e moving mechanical parts during the lowering of the tray. This function requires that the battery has not bee n removed and NOT fully discharged

Contact SCALEO Medical if one of these elements has a dysfunction or if some of the parts are damaged.

Charging and discharging the battery

The Shado® E is equipped with a 24 Vcc battery/power pack and security devices which protect the users of this equipment : - Emergency stop button. (RED button) - Voltage limitation with alarm in case of

battery unloading. - Emergency lowering button in case of

battery unloading.( marked EMERGENCY) SCALEO Medical ships the Shado ® E with the emergency button placed in “ON” position. So before any use, make sure that the emergency stop button is released to “OFF” position.

When the battery is about to be completely discharged, a sound signal warns the user that the battery should be charged. If the battery is not charged quickly, the unit turns itself off and the raising/lowering functions are not active anymore. The battery should be charged regularly. To do so, connect the main 24/Vcc transformer to the Shado® connection current collector and then to the AC outlet.

A reserve allows the Shado ® to be operated if the sound signal rings during th e showering of a patient enabling it to finish the tr ansfer.

The battery must be recharged only with the charger s provided by SCALEO Medical. Charging a battery with a non adapted charger may c ause over heating, damage the different components and cause a fire hazard .


Charge of the battery

• Plug the AC plug into the main plug. • The green light turns on. • The orange light turns on when the battery is plugged correctly. • If the battery is completely discharged, charge it for at least 8 hours before using it again.

After a charge cycle, do not forget to cut out the main/24Vcc transformer from the main circuit then from the Shado ® connection current collector. The transformer is not guaranteed if the feeding cord i s cut (even partially).

It is not possible to over-charge the batteries. Ho wever, in order to guarantee good performance of the equipment, it is recommende d to apply a few minutes break after having charged the battery and before u se. It is also important to completely charge the battery.

We advise you to use a wall charger and a replaceme nt battery in order to insure permanent use of the Shado ®.

The wall charger for the electric Shado ® The battery is fixed on these supports (unit / wall charger). To withdraw, grab the handle A and pull as indicated by the C arrow. The stop motion device of the handle should release itself from the support joggles. To replace the battery, go through these steps in reverse order while taking care that the battery is properly positioned.

The green light is on when the wall charger is plugged in. The orange light is on when the battery is being charged. If the battery is completely discharged, charge it for at least 8 hours before using it again

.

C A


Raising and lowering the stretcher Electric models The stretcher can be raised by keeping the raising pedal pressed, which is the left one. The actuator will automatically stop when it reaches the high position. The stretcher can be lowered by keeping the lowering pedal pressed which is the right one. The actuator will automatically stop when it reaches the low position. In order to stop the raising or lowering process, stop pressing the pedal. Up and down directions of the movements are figured by red arrows on the pedals. Hydraulic models The stretcher can be raised by pressing several times on the raising side of the pedal, which is the longest side. The stretcher can be lowered by keeping the lowering pedal pressed, which is the shortest side

Raising side = long side

Lowering side = short side

Raising pedal

Lowering pedal


Slope command The stretcher can be tilted around the middle axis . There is an important positive slope so as to drain the water during showering. Use the handle close to the head rail and release it once the desired position is obtained. Electric models The command is bidirectional and assisted by an actuator. Hold the head rail, positive slope is obtained by pressing the front button with the thumb, negative slope is obtained by pressing the rear button with the index finger. Hydraulic models Hold the head rail with both hands, press the command lever, adjust manually the slope of the trolley, set free the lever in order to keep the chosen position. Handheld remote control (option only for electric models) The wired remote control allows manual remote control of the raise and lowering, and the slope of Shado® electric models. The remote control of Shado® is IP65, perfectly sealed against spray water.

Lowering button

Raising button

Head down Head up


Opening and closing side rails Opening: Pull at the same time the left and right handles according to the picture below. During this operation, (the side rail must “go down/fall” freely onto your forearms). Then fold it back under the stretcher. Closing: Lift the rail up again till the limit stop, locking of the rails is automatic. A “click” sound must be heard.

Each time you use the trolley, please check that t he locks are fulfilling their function: the patient may fall off the trolle y if the rail opens unexpectedly

NEVER use the side rail for moving the trolley, the rail attachment could be deteriorated, and the rail fail unexpectedly

Pulling the handle for side rail opening

The rail is prop erly locked : the trolley is safe

The rail is not properly locked : DANGER

The rail may open unexpectedly


Taking care of the patient

Set the trolley next to the patient’s bed, either on the right hand side or on the left hand side, with the drain hole towards the feet of the patient. Fold back the removable rail on the bed side. Position the Shado® next to the bed. Adjust the height and tilting of the stretcher. Lower the mattress edge on the bed.

Do not bend over the mattress against the bed side: it could be

damaged Put the brakes of the trolley on. Roll over the patient on the Shado®. Raise the back of the stretcher with the pedal. Release the wheels and pull the trolley a step further from the bed. Raise the side rail back Set the head rest under the nape of the neck of the patient.

Transfer to the shower room Position the stretcher to the most convenient height to operate the Shado® comfortably. Select the guiding type for the wheels (centralized brakes option only)

- Free wheels for difficult operations.

- Unidirectional wheels for simple movements. One side is enough and always have to be opposite to the user.

Tilt the stretcher for the patient’s comfort

Transfers must be made in the lying down position a nd on the central section of the trolley in such a way that the weight of the patien t is spread according to his weight. It is absolutely forbidden to sit the patient at th e extremities of the trolley, this could damage the equipment and cause a fall. The use of technical aids such as sliding sheets or transfer boards is highly recommended, even essential to avoid the risk of mu sculoskeletal disorders of caregivers.


Always make sure you have properly raised the rails during transport. Always keep body parts away from the mobile structu re during the positioning of the stretcher. The shower trolley must not be used solely for the transport of people, do not ever use it to transfer objects, or on slopes or a carpeted floor. Assure yourself that you have enough room to manipu late the shower trolley: 80 cm wide for 160 and 180 models, 90cm for 200 and 240 models, 110 cm for 350 models.

Showering Block the wheels. Position the draining hose above a draining outlet. Adjust the slope of the stretcher to obtain efficient draining.

When the shower is over

Dry the patient

Put back the draining hose on its holder.

Unlock the wheels.

Bring the patient back to his room.

Perform an “after use” servicing routine before using the Shado® with another patient.

Refer to the “servicing and maintenance” section of this manual.

Optional equipments: - Wall mounted sanitary box: Allows patient showering and equipment disinfection. - Stainless steel waste disposer: Used to collect the Shado® water.


Servicing, periodical inspection, and preventive ma intenance

To maintain the performance of your Shado® trolley and ensure the comfort and safety of your patients, you should perform a regular maintenance operations including: Daily servicing After each use The Shado® must be cleaned and disinfected , like any device having direct contact with the patient skin. Depending on the frequency of use, and imperatively once in a day, a complete cleaning/ disinfection/ drying operation must be performed on the whole unit in order to maintain safety and perfect operation. For cleaning, use standard products approved by sanitary authorities. It should be made with liquid soap or non abrasive and chlorine free cleaning products. After use servicing The mattress and the cushion should be cleaned in the same way, without the use of solvent products, and rinsed extensively. The material used for the manufacturing of the mattress resists to most disinfection products if used at recommended dosages. Using chlorinated products at certain dosages may alter the colour of the mattress. Adjust the slope of the stretcher to obtain efficient draining and avoid any stagnation under the mattress. Daily servicing Cleaning the structure of the Shado ® and the bottom surface of the mattress should alwa ys be done with the mattress off. Unscrew the draining hose and the inferior part of the hole which is under the stretcher. Unhook the mattress slings from under the stretcher Adjust the slope of the stretcher to obtain efficient draining and avoid any stagnation. Dry or wipe the surface of the tray in order to eliminate any residue.

For the electrical models, before going through any kind of maintenance, cleaning, or transport, make sure to unplug the trolley if it is being charged. If the trolley breaks down or if you observe any ki nd of problems, do not try to repair it by yourself. To get it repaired, get in contact with SCALEO Medi cal customer services, a qualified technician or your authorised dealer. In all cases, insist on using original spare parts. The use of the electrical model, just as any electr ical equipment requires the abidance to a certain amount of fundamental and log ical rules like for instance not to pull on the cable to unplug the cable. When not in use, make sure the brakes are on, and c heck the immobilization of the Shado ®.


Annual periodical inspection The Shado® shower trolley is a medical device – regulated by the amended 93/42/EEC European Directive – classified in the category of “patient lifters”. The Shado® shower trolley is therefore submitted to a mandatory annual preventive inspection in order to remain efficient and safe. The check list of the preventive visit inspection can be found in the B annex of the EN ISO 10535 standard relative to patient lifters requirements. Competent health authorities insist on periodical inspections and maintenance of medical devices in order to insure the safety of patients and caregivers. Please do not hesitate to contact SCALEO Medical after-sales services or your distributor in order to plan inspection and maintenance visits.

Preventive maintenance Preventive maintenance keeps the equipment fully operational in order to ensure a better life time of use and user comfort. Please refer to the following checklist in order to be aware of what preventive maintenance requires.


� Periodical inspection (PI) � Preventive Maintenance (PM)

Model : Serial number :

PI PM Checks made OK ?

Remarks/ cause of non conformity

� � Cleaning and decontamination � Base framework inspection: � � Geometry and flatness of base � � Axis and brakes � � Wheels cleaning and lubrification � � � Brake adjustement (depending on the model) �

Structure inspection � � Axis articulations � � Stretcher raising actuator attachments � � Slope actuator attachments � � � Good condition of all pins and screws �

Tray inspection � � Visual inspection and planarity � � Inspection of the accessories and rails �

Rails � � Good closing, opening and locking of side rails � � Head and foot rails inspection �

Commands and actuator inspection and testing � Battery support inspection ( E model) � � Electronics control box inspection ( E model) � � Charger inspection ( E model) � � Raising and lowering pedals test � � Slope function test � � Battery check ( E model) �

Mattress, cushion, � Inspection of attachment straps � � Good sealing � � Draining hose en plug and inspection and test �

Functional tests : � � Wheels: inspection, rolling test, brake test � � � Raising and lowering function without load � � � Raising and lowering function with maximum load

(180kg) �

� � Positive and negative slope test � � � Emergency stop and emergency lowering functions

tests �

Labeling: � � Identification plate inspection � � Periodical maintenance label �

According to the EN ISO 10535 standard, this equipme nt must be submitted to an annual inspection Controls done by : Date : C = Conform NC = Non Conform The cause of non conformity must be indicated One copy of this form should be handed to the customer, one copy held by SCALEO Medical or by the authorized distributor


Technical specifications

Electric Shado ® E

Hydraulic Shado ®

Maximum load capacity 160 180, 200, 240, 350, 350kg 180 kg ou 200kg

Tilting degree of stretcher- Depends on the height of the tray

Maximum values : +12° / - 3° , Minimum values : +7° / - 0.4°

Minimum distance from the floor (ground clearance)

55 mm

Wheels/castors Four 3 positions castors, operated by pairs or

Four independant 2 positions castors

∅ 150 mm single tired, except Shado® 350 models

∅ 150 mm double tired for the Shado® 350 models

Power Pack/ charger Voltage 24 VDC

2.9Ah

N.A.

Standard charger

Voltage

240V 50/60 Hz (1) Charging voltage 27,6VDC ± 2% Charging current Max. 300mA

Charging time 8 hours maxi

N.A.

Wall charger Tension 240V 50/60Hz (1) Charging voltage 27.6VDC ± 2%

Charging current 650mA Charging time, 4 hours max

N.A.

Number of cycles; Up and down with full battery

≈ 40 cycles N.A.

IP protection IP65 (protected against splashing water)

Temperature of storage and use + 5° C mini to + 40° maxi

Fire resistance Tray, mattress and cushion : M2 ( NF P92503 standard) and BS7177

Actuator plastic case UL94V0

Electric box UL94V1

Tray, mattress and cushion : M2 ( NF P92503 standard)

and BS7177

Total weight 103 kg to 140kg dependign on the model and options

# 83 kg

Compliance with norms and regulation

All the Shado® shower trolleys models are compliant with essential requirements of the 93/42/EEC Directive relating to Medical Devices.

All the Shado® shower trolleys models meet the requirements of European standard EN 10535 relating to hoists for disabled persons and EN 12182 relating to technical aids for disabled persons

Electro Magnetic Compatibility All models are conform to European standard EN 60601-1-2

N.A.

Safety of electromedical devices All models conform to European standard EN 60601.

Electrical Protection Class 2.

N.A.


Shado ® tray, mattress and cushion specification Material The tray of the Shado® is made out of a material with properties ideally suited to intensive use: PVC. This is a flat panel manufactured by extrusion, completely homogeneous and nonporous. The mattress is made of polyurethane foam coated with protective PVC fabric. Humidity resistance PVC is versatile and ideally suited for wet areas. Thanks to its very dense and homogeneous composition, PVC gives the tray and the mattress of the Shado® an exceptional resistance to moisture. The material is resistant to mildew and rot, as for the heart than to its surface. Impact and scratch resistance The tray of Shado

® has excellent flexural strength and impact resistance.

It is for heavy use and has exceptional resistance to scratching. Fire resistance The tray has an excellent resistance to fire: the material does not melt, does not drip, does not explode under the effect of flame or heat and remains stable for very long. The tray material was classified M2 / F0 by an accredited laboratory. The mattress and cushion are also classified M2, and conform to the BS7177 standard, level of protection "medium" ( BS7177 is a standard relating to resistance to ignition for bed mattresses). Chemical resistance PVC has excellent resistance to chemical products and some solvents. In doubt, consult the product data sheet on its compatibility with PVC, and try it on a small area before use. The panel is also resistant to dyes, disinfectants and cleaning chemicals, even if frequent use of acids. They do not alter or properties or appearance.. Biocompatibility : PVC is approved for human consumption and medical, so contact with the skin is allowed without any risk of allergic reaction. Ease of maintenance The closed surface and non-porous structure of the panel surface prevents the adhesion of dust and dirt, and facilitates maintenance. The remarkable durability, resistance to abrasion, moisture, and chemicals allows an easy maintenance. Easily cleaned using conventional cleaning products, it also supports the application of aggressive disinfectants due to its excellent chemical resistance. Dirty trays can be easily cleaned using an organic solvent without alteration.


Terms of warantee

The Shado ® shower trolley and its accessories are guaranteed during 2 years . The battery pack is guaranteed during 1 year.

- Any intervention on the machine contrary to this manual will entirely void the guarantee.

- Any abnormal use or non compliant usage will entirely void the guarantee.

- Any modifications to the device will entirely void the guarantee.

- Any technical intervention made by non qualified personnel or a non authorized distributor will entirely void the guarantee

Liability

SCALEO Medical assumes no liability for any injury or harm and consequences thereof directly or indirectly caused to operators, patients, or any third party in the following cases:

- Non compliance to the instructions or recommendations supplied within this User Manual,

- Using maladjusted spare parts or accessories,

- Assembling, adjusting and repairing carried out by non qualified personnel,

- Abnormal use of the equipment, negligence, accident, human error, or maintenance and cleaning with non-adapted products

- Non compliance to servicing and annual preventive maintenance requirements according to EN 10535 B annex requirements, and requirements from local health authorities..

SCALEO Medical products and accessories are at least 90% recyclable. The end of life disposal of the device must be done respecting the recycling circuit and local relevant regulation. This particularly concerns the electrical and electronic equipment (WEEE) and the lead battery (B A). For waste management that respects the environment, please kindly contact the sales manager in your area.

All technical information, data and instructions for operations contained in this User Manual were up to date at the time of print and are compiled on the basis of our experience and knowledge. We reserve the right to incorporate technical modifications within the scope of further development of the product described in this manual.

Disposal


Manufacturer / Fabricant

SCALEO MEDICAL 107 rue Dassin, Parc 2000, 34080 Montpellier – France

We hereby declare that the following product:

Déclarons sous notre entière responsabilité que le produit suivant :

SHADO® shower trolley Le chariot douche SHADO ®

Class I , according with article 4 first paragraph of the appendix IX in the European directive 93/42/EEC, “All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies” Classe I, suivant le premier paragraphe de l’article 4 , annexe IX de la Directive Européenne 93/42/CEE, « Tous les dispositifs non invasifs font partie de la classe I, sauf si l’une des règles suivantes est d’application »

Is compliant with / est en conformité avec :

The council directives concerning medical devices 93/42/EEC, electromagnetic compatibility

2004/108/EC, electric equipment 2006/95/EC , the French Public Health code, By conformity to the Harmonized European standards réf: NF EN 10535:2007, NF EN 60601-1: 2007,

NF EN 14971:2009

Les Directives et leurs amendements du conseil relatives aux dispositifs médicaux 93/42/CEE, à la Compatibilité Electro Magnétique 2004/108/CE, aux équipements « basse tension » 2006/95/CE, le

Code de la Santé Publique Par conformité à la norme harmonisée européenne réf : NF EN 10535:2007, NF EN 60601-1: 2007,

NF EN 14971:2009

This declaration is based on following elements : Cette déclaration est basée sur les éléments suivants :

• Technical folder proving conformity to the 93/42/EEC Directive Essential Requirements • Documentation technique démontrant la conformité du produit aux exigences essentielles de la

Directive.93/42/CEE Montpellier, October 06, 2015 / 06 Octobre 2015 Expiration date 10/06 2020 date d’expiration : 06/10/2020 Michel MALGOUYRES, Managing Director, Michel MALGOUYRES, gérant

EC declaration of conformity

Déclaration CE de conformité


The information and advices provided in this user m anual are also intended to inform you of the importance of paying attention to securi ty measures and the necessity of

regular maintenance of your shower trolley.

This is a matter of responsibility for your establishment, and a question of safety for your patients and staff.

Please do not hesitate to contact us if you require electrical diagrams, lists of spare parts, descriptions and/or any infor mation that could be useful

for your qualified technicians.

Parc 2000,

107 rue Dassin, 34080 MONTPELLIER - FRANCE

Tél : + 33 467 72 94 86 - Fax : + 33 499 74 01 79

http://www.scaleomedical.com

Email : [email protected]

Documents

Made In France - medimec.it · The emergency lowering function allows the Shado ® E to be swiftly lowered in case the patient needs to be transferred out of the trolley or if control