DreamLine Instructions for Use and Maintenance Rev B Sept 2012

Gebrauchsanweisung Instructions for use and maintenance

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Gebrauchsanweisung Instructions for use and maintenance

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Gebrauchsanweisung Instructions for use and maintenance

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Gebrauchsanweisung Instructions for use and maintenance

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Gebrauchsanweisung Instructions for use and maintenance

A. Unpacking The DreamLine is designed to be stored and used at temperatures between 5° and 45°C and relative humidity between 30% and 75% rel.F. The DreamLine is almost completely assembled when delivered. Only the headboard, footrest and armrests (optional) needs to be mounted.

B. Assembly 1. Mounting the headboard The headboard is mounted easily on the adapters of the lying surface frame. Afterwards the two levers have to be closed. Both sides of the headboard have to be placed simultaneously to avoid tilting the headboard.

2. Mounting the footrest Insert the footrest from the front into the guidance of the frame until the end position is reached. Then connect the footrest to the motor with the Allen screw.

Allen screw

Footrest guidance

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Gebrauchsanweisung Instructions for use and maintenance 3. Electrical Outlet The plug on the power cord is to be connected to a 230 Volt / 50/60 HZ outlet fused by 16 A depending on the data on the rating plate. Passing over the power cord with the wheels should be avoided by appropriate installation. To avoid any damage, the net cable has to be rolled up before moving the chair and has to be laid on the mattress or hung up over the armrest in the rolled up condition. 4. On/Off switch The On/Off switch is located at the head part of the frame underneath the lying area. The mains connection should be switched off if the dialysis chair is not in use. After switching off please ensure that all buttons of the remote control are locked. 5. Equipotential bonding The DreamLine includes an equipotential bonding as standard. The connection bolt according to the DIN 42801 standard for potential adjustment is located on the head side of the frame. 6. Accessories the chair can be equipped with: 6.1 6.2 6.3 6.4 6.5

Armrests LED lamp IV-pole Held-up support Guard rails

Assembling of accessories only by authorised personnel. All accessories should only be used in combination with the DreamLine.

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Gebrauchsanweisung Instructions for use and maintenance

C. Instructions for handling Intended use for Bionic therapy chairs is the temporary sitting or lying position of patients or donors during treatment under medical supervision. By using the chair for x-ray diagnostics please consider that it is opaque to radiation. The chair is designed for people of normal size. It can be adjusted to the patient size by pulling out the head rest and/or adjusting the footrest. The chair does probably not meet the needs of (especially mentally) handicapped people. In case of doubts medically skilled staff should judge whether the chair can be used or not. All users of the chair, especially personnel, patients or donors have to be instructed in the handling of the chair and have to be made aware of the risks. We recommend to hand out this instruction to all users and to make sure that it is read and well understood. Please make sure that the notches of the seat segment are locked and secured with the three notches on the corresponding bolts of the seat frame. When not using the chair it should be moved into the lowest position to avoid the risk of injuries when getting in or out of the chair. Please make sure that movements of the chair are not restricted by architectural facts i.e. window sills, maintenance cables etc. Damage of the back segment motor or of the joints can occur. If you use lifter please take into consideration that its legs should not be higher than 110 mm. The ground clearance is 30 mm. If the chair is used in combination with a table, height adjustment may only be engaged when the table is removed. If the sitting patient is to be moved in the chair over a long distance the most upright position is to be adjusted. 1. Functions of Remote Control The DreamLine chair is equipped with five setting motors, permitting the patient to adjust the chair to the most comfortable sitting or relaxing position by finger tip control. The motors can be activated either by the patient or the staff through the remote control. Two motors adjust the inclination of the single segments and also two motors vary the sitting height from 55 cm to 95 cm. The fifth motor allows adjustment of the footrest. When released, the pressed switches automatically return to inactive position and the initiated movement stops immediately. The motors stop automatically once the end position is reached. The green light indicates that the DreamLine is properly connected to the power supply. The orange light shows that the remote control is used and the motor is moving.

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Gebrauchsanweisung Instructions for use and maintenance

Tilt seat segment up Back segment up Leg segment up Back segment down

Leg segment down

Tilt seat segment down

DreamLine up

Footrest up

Footrest down Sitting position

DreamLine down Lying position

2. Shock position The shock position of > 12° is set using the foot switch on the front part of the base structure. The foot pedal offers the benefit that nursing assistants’ hands remain free in an emergency. When the foot pedal is actuated, the backrest and height adjustment are lowered and the seat and leg sections moved upwards. 3. Adjusting the footrest Precise adjustment of the footrest is performed by the electrical motor operated by the hand switch. This precise adjustment should be set only after the patient has been seated and the desired seating position is fixed. Once the footrest is set correctly, the entire sole of each foot should rest comfortable on the upholstered surface. Readjusting the angle between the leg and seat section naturally changes the angle of the knee joints, so that major changes in the seating position usually also require slight adjustment of the footrest position. Handbuch_Deutsch_Englisch_DL_2012-09-25.doc

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Gebrauchsanweisung Instructions for use and maintenance 4. Height Adjustment For fistula or graft punctures and other medical procedures it is often advantageous to have the patient elevated in the chair. Also patients with impaired mobility can transfer more comfortable and safely if the height can be adjusted. During treatment and transport, however, the lowest sitting level should be used for better tilt resistance and psychological comfort. 5. Central fixing brake The DreamLine includes a central fixing brake as well as a steering lock. All 4 wheels are braked or the right wheel in the front is locked for easy moving of the chair by using one central lever located at the front part of the base frame.

Picture1: all wheels braked

Picture2: all wheels free

Picture3: Steering lock

6. Entry and Exit During entry and exit of a patient the central brake should always be in blocked position. For entry and exit, both armrests should be swung backwards or should be removed.

The footrest is not intended to be used as a step. Stepping on it with full body weight can tip over the chair. The armrests are not intended to be used for the entry. If the armrest is stressed excessively especially in the front it could brake.

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Gebrauchsanweisung Instructions for use and maintenance 7. Armrests (optional) Before using the armrests, the adapter as well as the adjusting mechanism has to be mounted to the DreamLine.

Armrest adapter

Adjusting mechanism

7.1 Mounting the armrests To insert the armrests into the adapter the back segment should be in upright position and the armrest in vertical position. Turn the armrest with slight counter-pressure to achieve locking by the slide catch. Once the armrest is fully inserted and secured, it can be moved up- and backwards as desired.

7.2 Removing the armrests In order to facilitate the entrance from a wheelchair into the therapy chair, the armrests can be removed. For this it is necessary to swing the armrest easily backwards to reach the slide catch and the armrest can be pulled off the chair.

During the transport of the therapy chair through doors or in elevators the armrests have to be removed to avoid damages.

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Gebrauchsanweisung Instructions for use and maintenance 7.3 Adjustment of Armrests At the front part of the armrest there is a ball and socket joint. To adjust the armrest loosen the locking lever underneath the ball and socket joint. Then move the armrest into the desired position and screw tightly the locking lever to fix the armrest position.

Ball and socket joint Locking lever 8. Guard rails (optional) If necessary four guard rails can be easily attached to the mattress holders using the plastic adapters. The base frame shell can be used as a storage area while the guard rails are not in use. Besides it is possible to mount hooks to the head segment to store the guard rails.

By using the guard rails together with the armrests, the armrests have to be adjusted parallel to the mattress to avoid any damages. 9. Held-up support, IV-pole and LED lamp (optional) For mounting the held-up support and/or the IV-pole there is a receptacle (optional) at the head part of the frame underneath the lying surface. The LED lamp is mounted on the movable part of the back segment frame.

Held-up support or IV-pole should not be placed at the same side as the LED lamp!

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Gebrauchsanweisung Instructions for use and maintenance 10. Tipping over and inadmissible load The chair can be used for patients up to 200 kg. For regular use the chair has enough stability. Leaning or sitting of the patient or a second person on the backrest or the leg segment in horizontal position as well as on the armrests is inadmissible. The footrest is not designed as a step; stepping on it might also tip over the chair. Extreme dynamic stress from falling back or rocking may also overload the construction. The armrests are not intended to be stressed excessively in the front. This could lead to a damage of the armrests.

The maximum load for each armrest is 40 kg.

11. Electrical Safety The ComfortLine is designed for maximum safety against electrical shock hazard. Drive and remote control are powered with low voltage of approx. 40 V DC, supplied by an enclosed isolation transformer, according VDE 0551/IEC 14D. The power supply ought not to be grounded and the plug (including primary fuse – A 1.6 T) has to have only two pins for this reason. Electrical safety is ensured by low voltage and the isolating transformer and therefore does not depend on the presence of a protective conductor system. The chair is secured against spray water by full casing of the control unit and motors. The chair includes a potential adjustment. The dialysis chair is fitted with an equipotential bonding.

Though the chair complies with electro magnetic standard for medical devices you should avoid the usage of high electro magnetic radiating devices (e.g. mobile phones, wireless LAN devices).

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Gebrauchsanweisung Instructions for use and maintenance 12. Battery reset in case of power failure Three exchangeable 9-Volt dry cell are placed in a box in the middle underneath the mattress. In case of power failure, the batteries supply power to return a patient into a safe and convenient position. The batteries have only capacity for a few adjustments and should be replaced after such an emergency operation. Please take care of local regulations when disposing the old batteries. Head segment

Box with batteries

D. Maintenance, Inspection and Care Although all mechanical components of the chair are maintenance free, we propose an annual inspection of the chair. Please see the following pages. The bearings of the drive are filled with a permanent greasing and must not be greased or lubricated. For disinfection of the dialysis chair, we recommend the disinfectant Meliseptol® from the company B. Braun in Melsungen (Germany). Please observe the Meliseptol® use instructions. Leave the dialysis chair to air after disinfection to prevent undesired reaction with the chair materials. The mattress of the DreamLine is waterproof. Because of hygienic reasons we additionally recommend the use of a separate cover. The upholstery is largely resilient to many alcohol-based cleaning and disinfection agents, but also to mild soaps. In case of doubt, a test on a small surface outside the visible area is advisable.

Strong acidic or alkaline disinfectants or disinfectants comprising aggressive substances (e.g. peroxide) can cause irreversible damage to the chair materials. Handbuch_Deutsch_Englisch_DL_2012-09-25.doc

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Gebrauchsanweisung Instructions for use and maintenance Depending on your usage, we recommend wipe disinfection of all surfaces in contact with the patient after every use. You should a least wipe-disinfect the chair once a day. Please use a wet cloth for cleaning. Every kind of maintenance and service on the chairs has to be done by authorized personnel. If you are interested in getting authorised contact [email protected], your local distributor or our international sales department directly.

E. Type Plate The type plate with serial number is attached to the cover of the power supply unit underneath the seat. For technical questions and spare part orders please indicate type of chair and serial number. The symbol

indicates that the therapy chair contains a functional bonding.

The symbol marks equipment of type class B, referring to the approved leakage current, features a high degree of protection against electrical shock. The sign  stands for product compliance with EC medial device directive (MDD) 93/42. The symbol marks equipment with special safety requirements to prevent electrical shock. The protection against electrical shock is not only secured through base-insulation, but there is also additional doubled or reinforced insulation. In consequence, equipment of this type is extremely safe for patients and medical staff. The

sign shows that it is necessary to pay attention to the accompanying documents.

The sign

stands for the equipotential bonding.

The data for intermittent service refer to the approved load period of the motors. Long time operation results in temperature rise of the motor winding, which can lead to damages. Intermittent service “2 min/18 min” means that after continuous motor operation of two minute, a recovery cycle of 18 minutes is mandatory.

Bionic Medizintechnik GmbH 61381 Friedrichsdorf, Germany www.bionic-jms.com



Typ: DreamLine

s/n: 11K21-001

Pri. Volt: 230 V 50/60 Hz AC Auf./Con.: 260 W Class: IP X4 Sich. Arbeitsl./Max. Load: 200 kg

Sek. Volt: 24 V DC Si./Fuse: 2,0 A Ausetzb./Interm.-Op.: 2 Min./18 Min.

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Gebrauchsanweisung Instructions for use and maintenance

F. Others The dialysis chair is designed for a typical economic life-time of 10 years. Please take care of your local waste regulations when disposing the chair.

Manufacturer's Recommendations for the Inspection of Dialysis Chairs The inspection should be performed at least once a year and should only be made by staff that is well educated, has the corresponding skills and is trained practically. In the respect of this inspection the inspecting staff must decide free of any disciplinarian instructions. A safety-related check (measurement of the leakage current according DIN EN 62353) is also possible. We recommend inclusion of the following points in the inspection: External Damage -

Damage to casings (hand switch, motor casing, mains plug) Damage to cables (insulation, pressure and pinch points) Damage to plug contacts (bend pins) Damage to frame parts (deformation, wear and tear) Damage to accessories connected to the product (deformation, wear and tear) Damage to O-rings (if present) of plug contacts Function order of the mains plug

Functional Examination First switch all drives to end position. When the end position is reached the drives have to stop. Check the operation of the traction relief in the sites where cables emerge from the casings / the dialysis chair. Take care that the cables do not cross squeezing and shearing points. Check plug connections for firm fit. This way, major repairs can be avoided. You should therefore also train your staff to be attentive to visible or audible irregularities.

The following checklist for the annual inspection with the documentation of the safetyrelated check is just a reference and not obligatory.

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Gebrauchsanweisung Instructions for use and maintenance

Checklist for BGV A3-Inspection DreamLine, Ser.-No.: Groups

Page 1: Visual Inspection

Part

OK

def. Possible damages

Handswitch

Housing

Cables

Motor housing breakings, lacerations, cuts, crushing, abrasion

Controls casing Main plug (optional: rechargeable battery) Power cord (optional: rechargeable battery) Handswitch cable Motor connection cable Handswitch

Plugs

Frames Connections

Motor connection Main plug (optional: rechargeable battery) Height levelling

breakings, cracks, cuts, sharp bends, discoloration of cable sheaths, abrasion, indentations, brittle parts, visible isolation inside or metal contacts, bended contacts / break off not connected, bended tiller or dented shielding, snapped base, damages on socket-rims and plug-Oseals, bolt clip damaged or not existent deformation, indentations, laceration or breakings, abrasion, sign of wear, rust

Hinges of slatted frame Back / sitting segment

deformations, cracks or breakings sign of wear, rust

Sitting / leg segment Armrests

Accessories

IV-pole

deformations, sign of wear, breakings or cracks

Reading lamp Sit up help

Shells

Base frame

deformations, indentations, breakings or cracks, abrasion or sign of wear

Lying area Of/off switch

Power supply Central brake Hand switch 9-Volt-Battery

function flawless

Foot pedal for shock position Traction relief / bend protection

cable slips, damages of PG-fittings

All 4 wheels

notches of the brake/function of the wheel

Handswitch reset

zero position

main supply cut off (2 each)

function flawless

Cable

breakings, cracks, cuts, sharp bends, discoloration of cable sheaths, abrasion, indentations, brittle parts, visible isolation inside or metal contacts, bended contacts / break off

Plug

not connected, bended tiller or dented shielding, snapped base, damages on socket-rims and plug-Oseals, bolt clip damaged or not existent

Charger

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Checklist for BGV A3-Inspection DreamLine, Ser.-No.: Functional Test

Page 2: Functional and Electrical Test OK

def.

Remarks upper limit switch

Back segment motor

lower limit switch unusual noise upper limit switch

Leg segment motor

lower limit switch unusual noise

Motors

upper limit switch

Height adjustable motor (head side)

lower limit switch unusual noise upper limit switch

Height adjustable motor (leg side)

lower limit switch unusual noise upper limit switch

Foot rest motor

lower limit switch unusual noise

Leak currents (DIN EN 62353)

Test instrument (model):

Test certificate

Test passed

Security related labelling readable?

yes

no

yes

no

(Enclose data sheet)

Position / Room: Test passed. The chair is conforming to the safety requirements. Minor changes. Minor non-conformities. The chair can be only used under restriction of a person in charge. Test failed. The chair must not be used before repair / reinspection. Date, Signature::

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G. Technical Data Dimensions (without armrests) Sitting height (incl. mattress) Armrest dimensions Adjustable angles

Width Length Height max. Height min. Length Width Back rest Leg rest Thigh segment Footrest by motor

ca. 900 mm ca. 2300 mm ca. 950 mm ca. 550 mm ca. 470 mm ca. 130 mm ca. 0° - 75° ca. 0° - 25° ca. 0° - 25° ca. 230 mm 200 kg ca. 123 kg

Maximum load Weight net

Features:

Adjustment of back segment and leg segment with two independent motors, two motors for height adjustment as well as lying area and one motor for foot rest adjustment, emergency foot pedal for shock position, central brake system.

Equipotential bonding Type of protection in case of electric shock Degree of protection in case of electric shock Degree of protection against ingress of water Noise level Storage

corresponding DIN 42801 II (double insulated) Type B (limited leakage current) IP X4 (splash proof) LPA <65 (DIN 45 635-19 - 01 - KL2) dB(A) relative humidity 30% / 75% r.F

Intermittent Service Nominal voltage Nominal power consumption Primary fuse Rated frequency

2 Min. / 18 Min. 230 VAC 260 W 2 A slow fuse 50/60 Hz

_______________________________________________________________________________________________________________

For technical information, service and spare part orders: ________________________________________________________________________________________________________________

Bionic Medizintechnik GmbH Tel.: + 49 (0) 6172 / 7576-0 Fax.: + 49 (0) 6172 / 7576-10

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Max-Planck-Straße 21 61381 Friedrichsdorf /Ts. email: [email protected] www.therapychair.com

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