wissner-bosserhoff carisma bed instruction & safety manual · wissner-bosserhoff carisma bed,...

1T 08 9351 7500 E [email protected] W www.unicarehealth.com.au

Wissner-Bosserhoff Carisma BedInstruction & Safety Manual

Please read this manual before operation, for maintenance instructions and safe usage

The enabling power of applied knowledge

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Wissner-Bosserhoff Carisma Bed, Instruction & Safety Manual

T 08 9351 7500 E [email protected] W www.unicarehealth.com.au

Index1. Table of Contents ..........................................................................................................................2 Important Safety Note ...................................................................................................................32. Notes on Instructions for use / Explanation of Symbols ...............................................................43. Area of Use / Intended Use ..........................................................................................................44. Setting up the Bed ........................................................................................................................55. Technical Data for the Bed / Nameplate .......................................................................................55.1. Electromotor Patient Surface .............................................................................................65.2. Electric motor height adjustment........................................................................................66. Product Safety / Extract from applied Standards ..........................................................................77. Product Overview (Example Wood Décor T10) ............................................................................88. Description of electrical Functions ................................................................................................88.1. Backrest Function (BR) ......................................................................................................98.2. Legs up position (LU) .......................................................................................................108.3. Comfortable sitting position (CS) .....................................................................................108.4. Auto contour Function (AC) .............................................................................................108.5. Height adjustment Function (HA) .....................................................................................109. Safety Notes for Height Adjustment ............................................................................................ 1110. Control box (Optional).................................................................................................................1211. Delivery .......................................................................................................................................1212. Assembly ....................................................................................................................................1312.1. Patient Surface ................................................................................................................1312.2. Patient Surface Motor ......................................................................................................1313. Transport / Moving Bed ..............................................................................................................1414. Function Test ..............................................................................................................................1514.1. Handset “Carisma 07 JPF“ Function Description.............................................................1514.2. Handset – Rear Side with Locking Function ....................................................................1614.3. Calf rest / Mechanical ......................................................................................................1714.4. Braking / Moving ..............................................................................................................1814.5. Adjusting Side rails (Model 06) ........................................................................................1814.6. Adjusting Side rails (Release Catch 09) ..........................................................................1914.7. Adjusting Side rails (Model 09) ........................................................................................2015. Permitted Accessories ................................................................................................................2115.1. Lifting Pole (Accessories) ................................................................................................2115.2. Infusion Holder (Accessories) ..........................................................................................2215.3. Patient Surface Extension (Option)..................................................................................2215.4. Mattress (Accessories) ....................................................................................................2315.5. Urine Bottle Basket / Urine Bag Container Model 09 (Accessory) ......................................................................................................................2315.6. Handset holder (Accessory) .......................................................................................................2415.7. Side rail exntension for 06/09 Side rail (Accessories) ................................................................2516. Cleaning and Disinfection ...........................................................................................................2716.1. Initial Cleaning .................................................................................................................27


16.2. Disinfection / Sterilisation ..................................................................................................2816.3. Care Instructions for Wooden Parts ..................................................................................2816.4. Use of Cleaning Agents.....................................................................................................2916.5. Use of Disinfection Agents ................................................................................................2916.6. Damage to Wooden Parts .................................................................................................2916.7. Environmental Compatibility..............................................................................................2916.8. Quality ...............................................................................................................................2917. Help in case of Malfunctions .......................................................................................................3018. Storage .......................................................................................................................................3019. Safety Notes and Residual Risks ...............................................................................................3020. Maintenance and servicing .........................................................................................................3620.1. Completeness and Accessories ........................................................................................3620.2. Wear and Tear ...................................................................................................................3720.3. Functionality ......................................................................................................................3720.4. BGV A3/VDE 0751– Inspections of the Electrical Components of he Handset ....................................................................................................................3720.5. Castors ..............................................................................................................................3721. Useful Life ...................................................................................................................................3722. Disposal ......................................................................................................................................3823. Spare parts, Spare part lists and Service manuals.....................................................................3824. Nameplate and Labels ................................................................................................................3825. Guarantee and Service ...............................................................................................................3926. Contact Partner...........................................................................................................................3927. EC Declaration of Conformity .....................................................................................................40

Wissner-Bosserhoff GmbHTÜV CERT- Zertifi zierungsstelle der TÜV Rheinland Industrieservice GmbHAppendix C: Important safety and usage notes for nursing home beds ................................................45Intended Use and Purpose of Nursing Home Beds...............................................................................45Basic Functions and Uses of Nursing Home Beds ................................................................................46Use of Original Accessories and Released Product Combinations .......................................................49Setting up the Nursing Home Bed (Safety Clearances) ........................................................................50Cleaning and Disinfection of the Bed ....................................................................................................50Appendixes:Appendix A: Spare parts list carisma 09/10Appendix B: Nameplate – explanation of details using an exampleAppendix C: Important safety and usage notes for nursing home bedsAppendix D: Battery operation (option) - additional notesIMPORTANT SAFETY NOTE:Please make sure that you read the safety-relevant passages marked with a in the individual chapters of the instructions for use very carefully, and observe the details of Chapter 18 and of Appendix C. Non-observance of such instructions could lead to damage or injuries.

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Dear CustomersWe thank you for the trust that you have shown in purchasing one of our products. We are convinced that our product is fully able to cope with the requirements of everyday hospital life. The careful choice of materials, the use of highly modern technologies and not least, the thoroughness and team spirit of our employees, mean that our products have a large benefi t and a solid quality. We are sure that this will mean care is made easier for you.

2. Notes On Instructions For Use / Explanation Of Symbols This symbol indicates safety-relevant instructions, the non-observance of which could

have serious consequences (e.g. damage, injuries). For this reason it is essential that such instructions and notes are observed.

These instructions for use are intended for trained nursing staff or for those persons who are in charge of the commissioning and operation of this product.

Caution! A precise knowledge and observation of these instructions for use is a prerequisite for handling this product. They should therefore be kept carefully until the product is disposed of. To avoid operating errors and to guarantee operation without malfunction, the instructions for use must be available to operating personnel at all times. It is recommended that they are stored in the bed or in the bedside cabinet.

The texts and graphic representations in these instructions for use do not necessarily match the exact scope of delivery, as they are designed for all variations of the model series. The drawings and graphics are not to scale.

3. Area Of Use / Intended UseThe nursing home bed is normally used in the area of nursing and care for the elderly. This bed is used exclusively for this purpose.

It is used to compensate and ease handicaps for people in nursing institutes and care homes for the elderly, as well as to simplify nursing tasks.

Any other applications must be agreed beforehand in writing with the company Wissner-Bosserhoff GmbH. The product must be used as a utility for nursing, and is subject to the regulations of the relevant professional organisation.

This nursing bed is a medical product in the sense of the regulations and standards named in the following Chapter, „Product Safety / Extract from Applied Standards“. Accordingly this product may only be used under medical supervision. The decisive factor in whether nursing is medically supervised or not depends on whether this nursing takes place on the instructions of medical personnel or not (see EN60601-2-38:2000)


4. Setting Up The Bed• Make sure that the fl oor surface is suitable, so that no damage can occur to the fl oor. Floors that

are, for example, too soft, unsealed or with imperfections are not suitable. These fl oors are often not suitable: soft wooden fl oors, porous and soft stone fl oors, carpets with foam backing, soft linoleum or similar fl oor covering. If in doubt, please contact your fl ooring company and the Technical Customer Service of Wissner-Bosserhoff GmbH.

• Ensure that the bed stands freely in the room so that there is a suffi cient safety clearance all around the bed for all adjustment positions (including the tilting function). For the extreme positions of the bed, an additional safety clearance of 2.5cm from objects, walls and installations must be taken into account, as protection from entrapment. The safety clearance of the head end from objects, walls and installations is at least 20cm.

• Be aware of the existence of any mechanical and electrotechnical protective measures, such as wall-mounted bumpers and corner guards, RCB switches etc.

• Pay attention to the whereabouts of useful wall sockets for the mains connection for the bed. Positions are unsuitable that could lead to collisions or stretching when the bed is adjusted, or in which the mains cable stretches too far across the fl oor or even under the bed.

• In general, the use of extension cables or multiple adapters that may lie unsecured on the fl oor of the room should be avoided.

• Magnetic objects or magnetic fi elds must be kept at a distance

5. Technical Data For The Bed / Nameplate1For an explanation of the respective nameplate details – see Appendix B

• Outer dimensions: approx. 208 x 106 cm (depending on the wooden linning)• Nominal dimension of patient surface : 90 x 200 cm• Height adjustment: 36 to 80 cm depending on the model (measured central section)• Backrest adjustment: 70° / electric sliding backrest SBR 11.5 cm• Thigh section adjustment: 32° / electrical sliding thigh rest 4 cm• Safe workload LF: Up to 225 kg (175kg patient +30kg mattress + 20 kg linen and accessories) depending on model and fi ttings• Tilting: approx. sitting position 13° /legs up position 15°• Bed weight: approx. 125 kg depending on model and fi ttings• Protection type: IPX4• Noise level: approx 57 dB/A• Anwendungsumgebung: • the environment temperature lies in the range from + 10°C to + 40°C • the relative humidity lies in the range from 30% to 75% • the atmospheric pressure lies in the range from 700 hPa to 1060 hPa

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5.1. Electromotor Patient Surface• Electrical connection: 230 V 1,25 A 50 Hz• Protection type IPX4• Class of protection II• Output voltage 24 V / 32 V depending on model variant (please read nameplate)• Operating time of motors max. 2 min. adjustment operation, 18 min. pause• Power consumption up to approx. 320VA peak load• Adjustment speed approx. 5.4 mm/sec. 2

• Pressure force before redirection max. 3500N

1 All technical data are nominal data. Construction and manufacturing tolerances are in accordance with EN ISO 14253-1 and GUM-1:95

2 Approximate values according to the model design and load value

5.2. Electric Motor Height Adjustment• Max. voltage in idling mode 24 V Current limiting (ÜSA) max.10 A• Max. lifting force, direct 2x6000 N• Max. tensile load 3,000N• Adjustment speedv 10 – 14 mm/s (depending on model fi ttings and load)• Protection type2 IPX4• Class of protection III protective extra-low voltage• Operating time of motors max. 2 min. adjustment operation, 18 min. pause


6. Product Safety / Extract From Applied StandardsThe product bears the mark and thus complies with the German and European safety regulations to be applied to the product.

Since a hospital bed in the standard is not equipped with a so-called equipotential connection, a combination with other electro-medical appliances is not permitted without further safety measures being taken. Get in touch with our Technical Customer Service for further information. An equipotential connection can be optionally provided, if required.

2 in assembled condition

Standard Comment Standard Comment

Medical product acc. to93/42/EEC

MDD CE- Symbol DIN 33402 Body mass of people

Law on Medical Devices

MPG DIN 50967 Nickel-chrome and coppernickel-chrome coating

EN ISO 14971 Risk management applied to medical products

DIN 68861-1/ EN12720

Furniture surfaces

DIN EN12 182- relevant sections

Technical aids for handicapped people

EN 60529 IP code (protection from humidity)

In compliance with EN1970 :2004/A1- relevant sections

Adjustable beds for handicapped people

DIN EN 60601-1-2 EMV electromagnetic compatibility

In compliance with DINEN 60601-1- relevant sections

Medical electrical appliances

In compliance with DINEN 60601-2-38:2000/A1 - relevant sections

Medical electrical appliances and accessories

BfArM – recommendation:from 07-2000

Recommendations of Fed. Institute for Drugs and Medical Products

In compliance with EN12530

Castors for hospital beds

DIN EN 980 Graphical symbols for marking medical products

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7. Product Overview (Example Wood Décor T10)

8. Description Of Electrical FunctionsDepending on the model, the nursing home bed can be moved to the following positions by adjusting the backrest, the thigh rest and calf rest, and the height position:

Overview of handset pictogramsFig. 2

1. Head end2. Side rail3. Undercarriage4. Handset5. Foot end6. Backrest7. Thighrest8. Calfrest9. Castor brake


8.1. Backrest Function (Br)

The adjustment is made via the corresponding buttons of the handset.The BR moves towards the head end of the bed during the upward motion. This function enables patients/residents to fi nd a comfortable position without the feeling of becoming restricted in the upper body area.The natural movement of the body is thus supported by this technology.

Caution! Do not operate under load. When operating the mechanical emergency lowering of the backrest, (optional) this must always be fi xed to the mattress restricting bar or lifting pole to avoid a sudden lowering.

Recommendation: Handling can be simplifi ed by having the patient/resident fi rmly hold the lifting pole trapeze (if available) so that there is no load at all on the backrest.

Handling: Hold the BR in the set position and remove the load from it slightly. Turn the red lever (on the side of the motor unit covering) in the direction of the backrest.

Handling: Hold the thigh rest in the set position and remove the load from it slightly. Turn the red lever (on the side of the motor unit covering) in the direction of the thigh rest.

Caution! All electrical functions could have faults - unless you lock them and just release them for the duration of the function.

Caution! Other devices that emit electromagnetic radiation (e.g. radio telephones) can have an infl uence on electrical bed functions. For this reason in general it applies that bed functions not required have to be locked for reasons of safety. The use of such devices in the vicinity should be avoided as far as possible.

Caution! When moving the bed to different positions, it must be ensured that no persons, body parts or objects are in the adjustment area or between the head / foot end and the fl oor.

Caution! Since the system can be run via battery operation (optional), it is not enough just to pull out the plug in case of the motors functioning incorrectly. If an incorrect function occurs, please switch off functions via the control box and contact our Customer Service (battery operation option).

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8.2. Legs Up Position (Lu) +The adjustment is made via the above mentioned buttons of the handset.

Caution! For reasons of safety, this position may only be released by medical staff, or only “under medical supervision“! The handset keys are released via the safety key!

Due to the intended use, a Trendelenburg position is not necessary!

Caution! The legs up position is not used for elderly care beds for acute care in an emergency/shock position. Primarily this function is used only for effortlessly setting the legs up position for therapeutic reasons!

To avoid the risk of getting into an unintended shock position, it is strongly recommended that the (BR) is raised approx. synchronously with the legs up position (preset). It is important here that the head of the patient remains higher than the orthostatic point of the body (the liver).

8.3. Comfortable Sitting + Position (Cs)The adjustment is made via the above mentioned buttons of the handset.

Caution! In conjunction with a bed extension there is a danger of entrapment between extension and fl oor. Prior to every adjustment of the comfort sitting position it is essential that the patient surface is moved to an appropriate height!

The same applies when a linen holder is used!

Caution! For reasons of safety, this position may only be released by medical staff, or only “under medical supervision“! The handset keys are released via the safety key! (Chapter “Rear Side of Handset with Locking Function“)

8.4. Auto Contour Function (Ac) +The adjustment is made via the above mentioned buttons of the handset.

8.5. Height Adjustment Function (Ha) +The height adjustment is made via the above mentioned buttons of the handset.


Caution! Because two power units independent of one another are used for the height adjustment in the “carisma“ model, it is important, depending on the adjustment cycle, to move the patient surface at least once per day to the end position (highest or lowest position). This causes potential height differences in the patient surface to be equalled out.

Caution! The height of the patient surface must be adjusted to the size of the resident/patient to avoid the risk of a fall.

9. Safety Notes For Height Adjustment

Caution! Prior to every height adjustment of the bed, you must make sure that there are no objects, persons, animals or anything else in the danger area!

Always leave the handset in the locked position so that no unauthorised persons may manipulate the height of the bed! (see Chapter 14.2)

When tilting to the sitting position, make sure the tips of the feet do not get too close to the sides of the bed feet.

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10. Control Box (Optional)The electrical system represents state-of-the-art technology and meets the principles of initial fault tolerance. One of these safety precautions to guarantee initial fault tolerance is the control box. When using initial fault tolerance handsets, such as the Carisma 07 NPF with integrated locking mode, the control box is not necessary. Handling the locking device with the handset is described in the Handset chapters. Depending on requirements, the control box is located to the right or left of the patient surface.In case of malfunction of the electrical system, functions can be stopped via the corresponding rotary switch.

Handling:1. By turning the rotary switch to the “lock open“ symbol, the handset functions are released.2. By turning the rotary switch to the “lock closed“ symbol, the handset functions are locked.

11. DeliveryThe nursing home bed is generally completely assembled when delivered, or is assembled by specialists on-site.

The delivery papers should be used to make sure that all components have been delivered! Possible defects or damage should immediately be reported to the haulage company and to the supplier, and noted on the delivery note.


12. AssemblyIf required, for example for the purpose of replacement, simple assembly procedures can be carried out by technically authorised persons.

12.1. Patient Surface1. Position the undercarriage.2. With the help of a second person, place the patient surface on to the lifting elements so that the

screws are at the height of the frame.3. Twist the remaining screws into the holes intended for them and screw them fi rmly to the frame.

12.2. Patient Surface Motor1. Placed the motor beneath the patient surface into the sockets provided for it and fi x in place with the

slider (Fig.4).2. Connect the slot connections according to the diagram shown below. (Fig. 5)

Caution! The handset should be in the so-called “Resident Mode“. This means that the comfort sitting position (CS) and legs up position (LU) are unavailable! To release the above-mentioned positions, rotate the locking switch on the rear of the handset. (Chapter: Handset – Rear Side with Locking Functions)

Caution! Prior to every adjustment of the CS and LU positions it is essential that the patient surface is moved to an appropriate height! The same applies when a linen holder is used!

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13. Transport / Moving BedBring bed into mobile position and move bed (see Chapter Brakes / Moving). Hold only the head and foot ends when moving the bed (see Fig. 2). Under no circumstances may the bed be pulled/pushed with the side rails!

Caution! When transporting the bed, do not push it over the handset cable or over the mains connection cable. Use the cable hooks fi xed to the cable!

When moving the bed, make sure that the feet do not get caught in the moving castors or in the undercarriage covering.


14. Function TestBefore a nursing home bed is used for the fi rst time, several function tests must be performed and checks be made to ensure that the adjustments corresponding to the model have been achieved and are made without interruption.

These are explained in more detail in the following chapter.

14.1. Handset “Carisma 07 Jpf“ Function Description

Caution: set the locking switch before you start. (13.4)

Function 1 Backrest (BR) up / down

Function 2 Thighrest (TR) up / down

Function 3 Patient surface height

(HA) up / down

Arrow 4 Adjustment direction up

Arrow 5 Adjustment direction down

Function 6 Comfortable sitting position

Function 7 Legs up position

Diode (B) = green light fl ashing indicates currently activated function key Function key remains activated for approx. 10 sec. before moving automatically to locking mode

Diode (A) = Initial fault tolerance check If locking areas are released => LED lights up green

If power units are in operation => LED lights up red, as long as one of the action keys up/down (key 4 or 5) is pressed.

Error function is displayed if

a) red LED is permanently on

b) when key is pressed, if no LED display / beep occurs

c) Continuous beep

LED does not light up + beep when key is pressed (end position has been reached)

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14.2. Handset – Rear Side With Locking Function

Locking switch for various modes:

By turning the safety key, 3 modes can

be adjusted.

1. Locking mode = All functions are locked

2. Care mode = All functions are free to be used

3. Locking switch = Turn in desired direction

4. Resident mode = Functions 1 to 3 are free to be used

Replacing the handset holding hook:

Press holding straps inwards at points A and B and twist out handset holding hook upwards.

Caution! Be aware of any loose parts when replacing the handset holding hook.

Caution! Clip safety key into the groove provided for this! (with force) Clipping it into the ring below this will break the key!


Initial fault tolerance of the handset:When operating the keys, a short signal can be heard. This means that the handset function is being performed correctly. If a continuous sound is heard when the key is not pressed, either the handset function is locked by the control box (optional) or there is an error.

If there is an error here, please disconnect the bed from the mains supply (remove plug) and contact our Customer Service (see Chapter Contact Partners on page 38)

Handset : Caution! Without the release via the safety key, no individual functions for the comfort

seating adjustment (6+4 , 6+5) and for the legs up position (7+4 , 7+5) are possible, for safety reasons!

Since these positions may only be performed under „medical supervision“ (e.g. by a male nurse), it is essential to ensure that the safety key is not kept in the vicinity of the resident.

We recommend that the key is kept on the keyring of the nursing staff so that the key is quickly to hand if required.

14.3. Calf Rest / MechanicalHeight adjustment of calf rest.

The height of the calf rest can be adjustedvia ratchets.

Handling:

Raising:Hold the calf rest on the mattress holder(possibly on both sides) and allow it toclick into the desired position

Lowering:Pull calf rest to highest position and let itdown slowly.

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14.4. Braking/ Moving Caution! : Due to the intended use of the bed, its movability is limited. The bed is not

intended to transport patients, but only to move it to a fl oor suitable for it. Normally a level fl oor in the nursing room.

Operating the castor brake

Position (A) “STOP“The castor brake is in the brake position

Position (B) “RELEASED“The castor brake is in the released position

14.5. Adjusting Side Rails (Model 06)Side rails up/down

Operation:

Lowering (A):Raise and hold top side rail as far as itwill go. Press slider (C) sideways as faras it will go, hold tight it and let downthe side rail at the same time.

Raising (B):Push the top side rail upwards until button(C) clicks into place.

Caution! The central locking mechanism of the side rail does not provide suffi cient side protection. It serves only to ensure correct usage in accordance with instructions to the nursing staff.


14.6. Adjusting Side Rails (Release Catch 09)Side rails up/down

Operation:

Lowering (A):

Pull up side rail (C) and simultaneously pressin button (D) and hold.Slowly let side rail glide into the lowest position(A).

Raising (B):

Hold side rail (C) on the lower edge and pullupwards (towards B) until the button (D) hasclicked into position.

Caution! For some model variants there is a locking mechanism for the side rail in the “central position“. This position does not provide suffi cient protection from falling out.

Caution! Ensure that the locking mechanism of the side rail is in place by shaking it to and fro after adjustment. Adjustment – shake to and fro.

Caution! When lowering/raising the side sections (side rails) you must be very careful not to get fi ngers, hands or other body parts trapped between the side rails and the patient surface frame.

Caution! Restless or disoriented patients/residents could become entangled between the safety gaps of the side rails. For this reason we strongly recommend that side rail cushioning is used. This protects the patient/resident from potential injury risks.

Caution! Please use an extension if necessary for side protections to increase the height when using raised mattress systems, as well as the side protection cushioning available for this (accessories) as an important additional safety and protection feature.

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14.7. Adjusting Side Rails (Model 09)Raising/Lowering side rails

Operation:

1st level:Side rail is in lowered position.

2nd level:To restrict the patient surface, simply pull thehandrail of the side rail upwards until a “click“signals that the side rail is correctly in place.To continue adjusting the side rail, press bothrelease buttons (E) briefl y until the catch is releasedand then pull the side rail upwards simultaneouslyin one movement until the 3rd level(360mm from the patient surface seat section)clicks into place.

3rd level:To continue adjusting the side rail, press bothrelease buttons (E) briefl y until the catch is releasedand then pull the side rail upwards simultaneouslyin one movement until the 4th stage(400mm from the patient surface seat section)clicks into place.

4th level:The side rail is at its highest level. To lower theside rail, press both release buttons (E) briefl yuntil the catch is released and then press theside rail simultaneously in one movement untilthe next desired position clicks into place or untilthe 1st level is reached.

Caution! Ensure that the locking mechanism of the side rail is in place by shaking the side rail to and fro.

Caution! For the model with the Comfort patient surface the side rail must be adjusted to the 4th level (400mm).


The patient lifting pole is attached to thehead end on the frame of the patient surface.

Handling:1. Place lifting pole in the direction of the

arrow into the socket (A) provided on the patient surface frame.

2. Lock lifting pole by twisting it so that the bolt lies in one of the notches provided in the socket.

Adjustment of the lifting pole is possiblevertically (with tilting range) and horizontally.

Caution! The max. load capacity of the lifting pole is 750N.

Caution! When lowering /raising the side sections (side rails) you must be very careful not to get fi ngers, hands or other body parts trapped between the side rails and the patient surface frame.

Caution! Restless or disoriented patients/residents could become entangled between the safety gaps of the side rails. For this reason we strongly recommend that side rail cushioning is used. This protects the patient/resident from potential injury risks.

15. Permitted 3 Accessories 4

15.1. Lifting Pole (Accessories)

Caution! Since plastics are not unconditionally resistant to ageing, we strongly recommend that safety-relevant parts (in this case the grab handle and belt) are replaced with new ones after 4 – 5 years at the latest. The year of manufacture is imprinted on the product.

3 No liability is assumed for damage caused by the use of accessories not permitted4 Permitted accessories are those accessories recommended by the manufacturer

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15.2. Infusion Holder (Accessories)The infusion holder (like the lifting pole) isfi xed to the socket provided on the patientsurface frame.

The infusion stand is only intended for attachinginfusions, not for attaching infusionpumps or similar.

Caution! The max. load is 8 kg (2 kg per hook).

15.3. Patient Surface Extension (Option)The bed can be extended by 20 cm usingthe additional fi tting “patient surface extension“.

Caution! The patient surface extension may only be assembled in the factory or by authorised specialist personnel!

Caution! When the tilting function is operated (see Chapter 13.1 Function Description of Handset), you must ensure that there is suffi cient space between the foot end and the fl oor.

Caution! After operating the tilting function, the handset must be reset to the locking mode (see Chapter 13.2).


15.4. Mattress (Accessories)Our Universal mattresses (dimensions: 87x200x12cm) have special incisions on theirlower side. When the mattress is laid on thebed, it must be ensured that the incisionsmatch the rotation points of the patient surface.Only in this way can an optimum lyingcontour be guaranteed.

Caution! For safety reasons the mattress thickness (together with the standard

safety clearance of the side rails) may not exceed 12 cm, and should not be less than 10 cm!

Caution! We recommend that mattresses are used that are manufactured with a

min. volume weight of 40kg/m3 (RG 40)!

15.5. Urine Bottle Basket / Urine Bag Container Model 09 (Accessory)The accessories holder SD09 (A) is attached to theside rail or to the side panel.

Urine bag holders, bottle holders or handset holderscan be placed in the accessories holder.

Caution! Before you fi x the accessories holder, make sure that it cannot collide with other bed parts or fi ttings in the room.

Caution! The maximum permitted load on the accessories holder (A) is 2 kg !

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15.6. Handset Holder (Accessory)The handset holder (B) is used to placethe handset where the resident can reachit. It is placed in the accessories holder(A) Fig.23.

Positioning options

Caution! Since the handset is fl exible, it may not be used as assistance in getting up or as a handle.

The handset holder (B) is used to placethe handset where the resident can reachit. It is placed into the respective accessoriesholder (A) Fig.24/25.

Positioning options

Caution! Since the handset is fl exible, it may not be used as assistance in getting up or as a handle.


15.7. Side Rail Extension For 06/09 Side Rail (Accessories)1. Side rail2. Tilting arm3. Mushroom head bolt4. Clamping lever

Assembly:

1. Pull up the side rails of the nursing home bed to the highest position.2. Release the clamping lever (Fig. 27, Item 4) by turning it 90° and twisting out the mushroom head

bolt3. Place the side rail extension onto the side rail of the nursing home bed as shown in Fig. 28.

Caution! the side safety clearance from the head and foot ends must each be approx. 6 cm. Rule of thumb: The clearance must be equally distributed at both ends. For nursing home beds of special length (longer than 2 m) a side rail extension of special length must be used.

4. Twist in the mushroom head bolt and screw the clamping lever tight (Fig. 27 Item 4) by turning it 90°5. Perform a function test of the side rail, including the assembled side rail extension. (If there are

problems with the function, please contact our Customer Service at the phone number 02377-784-456).

Caution! You must pay special attention when adjusting the side rail. The risk of entrapment of body parts of the resident is especially high during adjustment procedures.

Caution! Placing the side rails at an inclination does not provide suitable or suffi cient protection from falling out of the bed.

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Caution! For side rail protections with extensions, please use the available side protection cushioning (accessory), which is an important additional safety and protection feature.


16. Cleaning And Disinfection16.1. Initial CleaningPrior to fi rst-time use the nursing home bed must be cleaned in accordance with the IP protection level.

Identifi cationletter

Protection level for protection from contact and impurities

protection level for protection from water

Cleaning and Disinfection

IP

1 code No.

Designation of extent of protection

2 code No.

Designation of extent of protection

0 No protection 0 No protection Cleaning with slightly damp cloth, spray and wipe disinfection

1 Protection from large (>50mm Ø ) impurities

1 Protection from verticallydripping water

Cleaning with slightly damp cloth, spray and wipe disinfection

2 Protection from mediumsized(>12 mm Ø ) impurities

2 Protection from obliquelydripping water (up to 15°from vertical)


3 Protection from small(>2.5 mm Ø ) impurities

3 Protection from spraywater (up to 60° fromvertical)


4 Protection from grainshaped(>1 mm Ø )impurities

4 Protection from splashesof water


5 Protection from dustdeposits

5 Protection from hosewater

with water and brush, without hard jet of water

6 Protection from infi ltration of dust

6 Protection from fl ooding with water and brush; stronger jet of water; no high pressure cleaner; cleaning in washing units permitted, depending on bed licence

7 Protection from immersion

with water and brush; stronger jet of water; no high pressure cleaner; cleaning in washing units permitted, depending on bed licence

IP protection types in accordance with DIN 40050 / EN 60529The digits following the letters IP specify how the current-carrying or moving interior parts of an electrical device are protected from solids or water penetrating from outside.

28



Caution! For safety reasons it is essential that the penetration or appliance of fl uids (e.g. water, solvents, oils, lyes, cleaning agents, etc.) into or on parts of the nursing home bed are avoided.

Caution! Housing that provides protection from the penetration of water does not necessarily provide the same protection from other fl uids!

Caution! For this reason the nursing home bed must generally be protected as much as possible from any kind of dampness! Cleaning should only be carried out with a slightly damp cloth.

16.2. Disinfection / SterilisationThe nursing home bed must be disinfected regularly, and at least before every change ofresident. The bed may not be disinfected in automatic washing units or with spray water. The following agents are recommended for the disinfection of the nursing home bed, and may only be replaced by equivalent agents:

Terralin, Perform and Sagrotan Med (Schülke & Mayr GmbH, Norderstedt).

These agents may only be used in accordance with the manufacturer‘s regulations! These refer particularly to the dosage of the agents and possible hazards in combination with other agents.The wooden lining must not come into contact with these agents.

16.3. Care Instructions For Wooden PartsWe have used materials of the highest quality to create a product for you with a high level of benefi ts and homely real wood character.

In order that you can gain pleasure for as long as possible from your Wissner-Bosserhoff product, we recommend that you clean with a slightly damp, soft cloth.

Each real wood material (veneer, solid wood) is subject to unnatural ageing process, even when varnished. Over the course of time, environmental infl uences such as UV radiation, humidity or warmth cause changes to the colouring of the real wood surfaces. In addition, wood as a natural material has, by its nature, a wide variety of shadings. The textures of veneers can basically only be generally specifi ed, since each trunk of a particular species of tree has its own characteristics. Slight variations in colour and contrast in deliveries from Wissner-Bosserhoff are natural, and technically unavoidable. This is particularly the case for refurnishing or replenishment deliveries.

For the reasons mentioned, relative differences in tone, contrast and colour between veneer surfaces, solid wood parts or patterned surfaces (melamin, HPL), as well as growth-dependent inclusions in real wood materials, do not represent defects, and Wissner-Bosserhoff GmbH cannot assume any liability or guarantees for this.

Through careful selection, consulting and colour coordination of veneers and varnish, Wissner- Bosserhoff guarantees a high-quality in the coloration of products.


16.4. Use Of Cleaning AgentsFor particularly stubborn stains, commercially available, environmentally friendly all-round household cleaners can of course be used. The furniture surfaces of Wissner-Bosserhoff products meet the requirements of Standard DIN 68861 - 1A for furniture surfaces subjected to chemicals, and thus have an excellent resistance to normal pollution.

No cleaners or cleaning agents may be used, however, that contain mechanically abrasive components and that have the effect of scouring agents. It must be ensured that no wetness or fl uid stains remain on the real wood and veneer surfaces when in use and when being cleaned. Wood is a natural product which has the property of absorbing moisture, and which expands in doing so. This can cause damage to the surface sealing.

For this reason the use and storage of wooden products under the infl uence of high levels of humidity must be avoided.

After cleaning, it is recommended that the real wood and veneer surfaces are wiped down with a dry cloth to avoid damage to the product through moisture as far as possible.

16.5. Use Of Disinfection AgentsOnly disinfection agents may be used that correspond to the disinfection agents described in Appendix 1 of DIN 68861 Part 1:a) Phenolderivates, 0.5-% aqueous solution: Chlorinated alkyl aryl-phenol, cycloalkyl - aryl-phenolb) Chloramin T, 2.5-% aqueous solution: p-Toluolsulfonchloramide-sodium

16.6. Damage To Wooden PartsIf the veneer or surface sealing is damaged by bumps, scratches or incisions, the surface must immediately be protected from the penetration of humidity by suitable repair materials. Please contact the Wissner-Bosserhoff Customer Service or a specialist company.

16.7. Environmental CompatibilityAll wooden materials used comply with strict German laws and regulations and are harmless in terms of health. The focus of our operation is on people and their environment.

16.8. QualityOur products are subject to strict controls through our quality assurance system in compliance with international standards DIN EN ISO 9001:2000 and DIN EN ISO 13485:2003 for the manufacture and distribution of medical products.

For all properties guaranteed, Wissner-Bosserhoff assumes a one-year manufacturing warranty. Claims that originate from improper or non-standard use or care are excluded from this. If you have grounds for complaint, please contact our Customer Service.

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17. Help In Case Of MalfunctionsMalfunction Possible Cause Remedy

E- Motor adjustments notmade correctly

• Mechanics are locked Check moving parts and remove any foreign bodies

E- Motor adjustments arenot performed

• Handset is defective Contact our Customer Service and request spare part

• Bed not plugged in to powersupply

Connect plug to power supply

• The system was overloadedand temperature safeguard hasswitched off

Wait for cooling down phase (at least 20 min., depending on overload). If the system still does not function, contact our Customer Service

The side rail cannot beproperly adjusted

• Mechanics are locked Check moving parts and remove any foreign bodies

• Mechanical parts are bent Contact our Customer Service

Castors do not brake or donot roll

• Impurities have become caughtin castors over time

Remove impurities

• The castor system is defective Contact our Customer Service

18. StorageThe following activities must be performed when storing the bed:1. Remove mains plug.2. Remove accessories such as lifting pole, serving tray, etc.3. Cover nursing home bed so that damage or scratches to paint cannot occur.4. Apply date of storage (for the purpose of maintenance intervals).

Caution! The same conditions apply for storage as for the working environment (see Section Application Environment).

19. Safety Notes And Residual Risks1) These instructions for use must be read and observed before the nursing home bed is used.2) The details of the nameplate must be observed.3) Because two power units independent of one another are used for the height adjustment, it is important, depending on the adjustment cycle, to move the patient surface at least once per day to the end position (highest – lowest position). This causes potential height differences in the patient surface to be equalled out.4) The bed may not be operated if it displays malfunctions that could cause a hazard to persons, employees or third parties.


5) The bed may only be operated by persons who can guarantee correct handling because of their training or knowledge and practical experience.

6) Before operating the bed, the person doing this must be satisfi ed with the functional safety and the proper condition of the bed.

7) The bed must be subject to a function test, possibly daily or with each change of shift, so that it is guaranteed that the bed can be used as intended without danger for the patient or the operator.

8) Do not repair and reuse lifting poles that have become distorted, but replace them.

9) The bed may only be moved on level and fi rm fl oor covering.

10) If the bed is occupied the castors must always be in braked position – otherwise there is a risk of the patient falling when getting in or out, since he may support himself on the bed-.

11) The height of the patient surface must be adjusted to the size of the patient to avoid the risk of a fall.

12) When operating the mechanical emergency lowering of the backrest, (optional) this must always be fi xed to the mattress restricting bar or lifting pole to avoid a sudden lowering.

13) When moving the bed to different positions, it must be ensured that no children, body parts or other objects are in the adjustment area.

14) Adjustments to the side sections (side rails) may only be made by nursing staff. When adjusting the patient surface positions, nursing staff must be satisfi ed that the patient will not come into contact with the side rails, to avoid entrapment of hands, legs or other body parts.

15) Extreme leaning out sideways of the upper body must be avoided.

16) Do not alone the side rails more than 75 kg in a vertical direction and more than 50 kg in a horizontal direction.

17) Depending on the physical and mental state of the patient, functions on the handset must be locked or released via a control box. The effectiveness of the locking functions must be tested with the handset.

32



18) Since the system can be run via battery operation, it is not enough just to pull out the plug in case of the motors functioning incorrectly. If an incorrect function occurs, please switch off functions via the control box and contact our Customer Service (battery operation option).

19) For adjustments via the handset, it is recommended that the operator remains in the vicinity of the control box so that possible incorrect functions can be immediately switched off.

20) Caution! All electrical functions can be faulty – unless they are locked through the control box.

21) For the power source, a 220 / 230 volt, 50 Hz mains plug in accordance with VDE stipulations must be used.

22) Do not touch the plug with wet hands. Only hold the mains connection cable on the plug and pull out from the mains socket.

23) Lay the mains connection cable without loops, do not bend or pull around sharp edges.

24) Generally protect connection cable and supply cable from mechanical stress.

25) Position the mains connection cable and supply cable to the handset so that they are safe from being squashed and do not place any objects on the connection or extension cable.

26) When setting up the bed in the room provided for it, safety clearances from the wall, windowsills and other objects must be maintained. Safety clearances depend on the design and model of the bed, for which extreme height adjustment and tilting movements are performed and at least 25 mm space for fi ngers must be maintained.

27) If the bedding and height adjustment functions are performed, it must be ensured that the safety key is not in the lock or in the vicinity of the handset (in the range of the patient resident). Through improper release via the safety key, positions can be achieved that may represent a risk to the patient/resident, such as a wrongly applied Trendelenburg position.

28) Place the handset in the holder provided for this (option) or on the bed so that the keys can not be pressed through being caught between two objects, e.g. between side rail and bedside cabinet.


29) Cleaning of the bed may only be carried out with a damp cloth.

30) If the bed is not used properly, dangers can occur through: • Unauthorised operation of electrical functions during the uncontrolled positioning of the bed,

• Using the bed for children under the age of 12,

• Operating functions of the bed by the patient without previous instruction,

• Simultaneous operation of electrical functions by different people,

• Connecting electrical devices to the bed that are not intended,

• Moving the bed by pulling the mains cable or side rails,

• Pulling the mains cable to remove the mains plug from the power supply,

• Lack of protection for the connection and supplied cables from sharp edges or other mechanical strains (e.g. running over the mains cable),

• Moving the bed on an unstable surface,

• Using the bed on a sloping surface with an angle of 10° or more,

• Devices that create strong electromagnetic fi elds and that may possibly infl uence the control of the bed are not permitted in the direct vicinity of the bed (e.g. mobile phones).

• Before cleaning or servicing the bed the mains plug must always be removed from the power supply.

• For safety reasons the lifting handle (trapeze) together with the strap must be completely replaced after 5 years at the latest.

• The mattress to be used must meet valid safety standards and may not be thicker than 120 mm.

• Continuously dripping fl uid in the motor unit area (e.g. in case of incontinence)

• Improper repair work on electrical installations

31) Safety notes – measures for the safe operation of hospital and nursing home beds:

• Electrical components on hospital and nursing home beds may only be repaired and serviced by the manufacturer or by specialist personnel trained specifi cally by the manufacturer. Otherwise there is a danger that specifi c procedures will not be performed directly through lack of knowledge of product functionalities, leading to an increased risk of electrical shock or fi re.

• Electrical components on hospital and nursing home beds may be replaced only with the original spare parts from the manufacturer, since replacement with incorrect components can lead to a highly increased risk of electrical shock or fi re.

• A safe location on the bed must be specifi ed for the hand controls, so that playing with the hand controls can be prevented.

34



• Cleaning the bed may only be carried out in accordance with the specifi cations in Section “Cleaning and Disinfection“ of these instructions for use, since increased risks could otherwise occur for which the manufacturer can take no responsibility.

• If incontinent patients occupy the bed, an incontinence protection for the mattress must always be used.

• If immobile patients/residents lie in the bed permanently, bed sores can occur if additional lying aids (e.g. pressure sore mattresses) and other special nursing measures for pressure sore prevention are not employed. Under no circumstances is this the responsibility of the manufacturer of the bed.

• The product is explicitly not suitable for permanent use. If the specifi ed operating time is exceeded, the power unit can heat up, causing it to switch off automatically. The power unit must then cool down for at least two hours, and can only be put into operation again after this time has expired.

• It is absolutely essential that a blockage of the bed or of parts of the bed mechanics is avoided, since this can lead to damage and to the total failure of the power unit through overheating.

• It is absolutely essential that the safe working load is not exceeded, since this can lead to damage and to the total failure of the power unit through overheating.

32) Servicing notes – Technical Safety Inspections – Notes on Rectifying

Errors:

• Electrically-operated hospital and nursing home beds are medical products and are subject to the so-called Technical Safety Inspections (TSI) in accordance with the Law on Medical Products (MPG) and the Medical Products Operator Decree § 6 (MedProdBetrV). This regular TSI should be carried out at least once a year. When this is done the functional and electrical safety in accordance with VDE0751, including a visual and function inspection (inspection of the resource in operation) must be performed, as well as an inspection of possible measuring functions

• In general the accessories and other devices that are combined with the product must also be inspected for technical safety. It must be ensured when doing this that only accessories authorised by the manufacturer and permitted combinations of appliances are used. These TSIs may only be undertaken by specialised electricians or persons instructed in electrotechnical matters using a special measuring and test device, who have been trained specifi cally by the manufacturer for the product and the permitted accessories and combinations of appliances. The person performing the inspections may not accept any instructions from the operator. Special test records must be written for each of the TSIs. The product itself should be marked with a test sticker displaying the next test date.


• Furthermore, electrically-operated hospital and nursing home beds are electrical resources, for the safety of which the employer is responsible. The monitoring function for this obligation is the responsibility of the German professional association for health service and welfare care (BGW) and the German industrial inspectorate. The regulations of the professional associations for Health and Safety at the Workplace (abbreviated BGV, formerly VBG) apply. In particular, BGV A3 (formerly VBG “Electrical Facilities and Resources“ (BGV A2)) applies to repeat inspections of movable electrical resources with a guideline of six months, but at least once per year. These inspections may only be performed by a qualifi ed electrician or a person instructed in electrotechnical matters, using a special measuring and testing device. The inspections in accordance with BGV A3 may also be performed by specialist staff trained by the manufacturer, in the context of the Technical Safety Inspections for Medical Devices, since these BGV inspections form a part of the Technical Safety Inspections.

• Electrically-operated hospital and nursing home beds are active medical products and must be maintained, in accordance with the German Medical Products Operator Directive (MedProdBetrV) in an inventory sheet for each premises. It is recommended that the correct implementation of the stipulated TSIs are also documented in this inventory sheet and that the next test date is specifi ed. The required records for the technical safety inspections already performed should be attached to the inventory sheet.

• The proper implementation and traceable documentation of the technical inspections, maintenance and service work specifi ed by the manufacturer, as well as the technical safety inspections, is a necessary prerequisite on the part of the purchaser that he may acquire rights of guarantee. If the operator of a medical product does not meet his obligations, risk of damage and accident may arise from this that are explicitly not the responsibility of the manufacturer.

• Servicing work must be performed in accordance with VDE0751-1 and be concluded with a documented technical safety inspection

36



20. Maintenance And ServicingThe nursing home beds of Wissner-Bosserhoff GmbH are generally designed for a useful life of 10-15 years. The beds here are extremely low in maintenance. This is because attention was paid during the development of the products to ensure that maintenance work was reduced to a minimum, with low operating costs.

In daily use, however, experience shows that there is also careless handling of products, and rough handling can also contribute to them ageing quicker and to the wear of certain components, on which the manufacturer can have no direct infl uence.

For this reason, routine servicing examinations should be performed by the operator – also to guarantee the availability of beds, which is in his own interest.

The Technical Customer Service of Wissner-Bosserhoff offers servicing and necessary training covering all aspects of the product. Wissner-Bosserhoff certainly places great emphasis on training for customers, since only trained operators and maintenance technicians can ensure proper handling and use of the beds.

Maintenance should be performed exclusively by competent specialists who have been trained for the product by Wissner-Bosserhoff.

The manufacturer assumes liability for the safety and reliability of the product only if it is regularly maintained and used in accordance with the operating, usage and safety notes in these instructions for use.

If a function control, an inspection, measurement or maintenance reveals serious defects that cannot be rectifi ed, the product must be suspended from further use.

Wissner-Bosserhoff GmbH recommends a simple mechanical servicing at yearly intervals.

In general the manufacturer assumes a servicing in accordance with the currently valid rules of technology, since a nursing home bed is equipment that is subject to the accident prevention regulations (UVV) of the professional association. For this reason, BGV A3 in conjunction with the VDE 0751 standard applies for safety inspections. Our Customer Service is available to you for any enquiries and to provide training andtest lists for individual products. (To make contact, see Sections 22 and 25)

20.1. Completeness And AccessoriesIt must be determined, by means of the delivery note, the instructions for use and a visual inspection, whether parts are missing, and therefore need to be ordered or replaced. In general the accessories and other devices that are combined with the product must also be checked. It must be ensured when doing this that only accessories authorised by the manufacturer and permitted combinations of appliances are used.


20.2. Wear And TearThe individual components of the nursing home bed must be examined for scouring, scratches or other types of wear in the context of an inspection and function control, and the cause must be determined and rectifi ed by the replacement of the individual parts involved. It must be possible to perform all locking mechanisms and adjustments in the correct manner. Pay particular attention to safety-relevant parts of the nursing home beds.

20.3. FunctionalityTest of whether all adjustments can be made to their maximum positions. Perform a function control using the Sections “Function Control“ and “Description of Nursing Home Beds – Functions“ in these instructions for use.

20.4. BGV A3/VDE 0751– INSPECTIONS OF THE ELECTRICAL COMPONENTS OF THE HANDSET• Test of whether the power units move in and out correctly, and whether the unit andhandset remain

in fl awless condition with respect to:• Checking of mechanics (screws, bolts etc. are tight, parts, labels undamaged, etc.)• Condition of cables, housing, etc. (cables crossed, squashed, etc.)• Function Test• Visual inspection• Suffi cient cable relief and protection from buckling• Discharge current test• PE conductor test for models in class of protection I• Insulation test if necessary

Our Customer Service is available to you for any enquiries and to provide training and test lists for individual products. (To make contact, see Sections 22 and 25).

20.5. CastorsTest of functionality of castors (moving – braking) and the removal of possibly accumulated dust, threads, hair or similar that may have been caught in the castors. If necessary the castor brakes must be readjusted. Please ask Wissner-Bosserhoff Customer Service.

21. Useful LifeIf used, cleaned, serviced and repaired correctly, a useful life for our products of 10 to 15 years can be expected. Excluded from this are wearing parts such as castors, pneumatic springs, electrical components, etc.

38



22. DisposalThe bed may optionally contain lead batteries, metal, wood and plastic parts made of ABS, PA, PUR, PE. (cf. scope of delivery and model).

The metal and plastic parts that accumulate during servicing and repairs must be disposed of properly and professionally in accordance with valid laws and regulations. Specifi cally the electric motors and electrical controls may only be disposed of through specialist fi rms authorised to do this.

23. Spare Parts, Spare Part Lists And Service ManualsOnly Wissner-Bosserhoff original parts may be used.

Customer Service, Sales and the technical consultation department provide information concerning spare part deliveries, etc. (for the address, see Contact Partners).

Spare part lists, current price lists and servicing instructions with exploded diagrams can be requested if required from Wissner-Bosserhoff, Technical Customer Service, by specifying the nameplate data of the bed or the relevant article number, order number and delivery date.

Customer Service T 08 9351 750024. Nameplate And LabelsIn order to handle enquiries or spare part orders, details of the nameplate are required.

An example explanation of the details on the nameplate can be found in Appendix B of these instructions for use.

The nameplates and labels of individual components (e.g. motor, pneumatic spring, hydraulics, handset) are also very useful.


25. Guarantee And ServiceWith the “charisma“ nursing home bed you have bought a Wissner-Bosserhoff quality product. This bed was manufactured with great care using high-quality materials and modern production techniques.

The “carisma“ nursing home bed“ has a 36-month guarantee

from the date of purchase. This guarantee covers all malfunctions and defects in materials and manufacture. Malfunctions and defects arising from incorrect handling and external infl uences are excluded from this. If there should be cause for justifi ed complaints within the guarantee period, however, these will be rectifi ed free of charge. This guarantee can be claimed with the purchase slip, which bears the date of purchase. Our general terms and conditions of delivery apply.

26. Contact PartnerManufacturer:Wissner-Bosserhoff GmbHHauptstr. 4-658739 Wickede (Ruhr)

For enquiries we can be reached at the following numbers:Customer Service T 089351 7500Email [email protected]

If you make enquiries, we would like to ask you to prepare for a phone conversation by noting the details on the delivery notes and the nameplates (see Appendix B of these instructions for use) so that the Wissner-Bosserhoff customer consultant can be notifi ed of these. If these data are not available, guarantee services in particular cannot be treated free of charge.

Service partners:

(Please stick reminder stickers here.)

40



27. Ec Declaration Of Conformity


Appendix A: Spare Parts List “Carisma“ 09/10

42



Enter important ordering details from the bed nameplate!Article No.Series No.Enter important ordering details from the control motor name plate!Article No.Series No.

44



Appendix B: Nameplate – Explanation Of Details Using An Example


Pendix C: Important Safety And Usage Notes For Nursing Home BedsIntended Use And Purpose Of Nursing Home Beds

A nursing home bed may only be operated and used in accordance with its intended purpose, in compliance with the regulations of the Law on Medical Products (MPG), the accompanying orders, the generally recognised rules of technology and the regulations on work safety and accident prevention. A nursing home bed may not be operated in a defective condition in which the bed could be a hazard to patients, nursing staff or third parties.

The conditions of the respective instructions for use of the product shall apply:

The following points must be observed: The nursing home beds of Wissner-Bosserhoff GmbH are intended exclusively for the

occupancy of persons from the age of 12 and above. This must be ensured, since persons with a body size or weight deviating from the normal average are exposed to an increased risk under certain circumstances. As the recommended standard range, persons in a range from a woman of 146 cm in height to a man of 185 cm in height (with a non-critical state of health and capable of acting independently at least to a certain extent) can occupy the bed without additional risks or restrictions in performance (in accordance with Standard EN 60601-2-38:1996 + A1:2000). Beyond this range, additional accessories must be used if necessary, or use is not possible. Bed extensions (accessories) should be used for larger persons, and it is essential that additional protective measures such as side rail protection covers (accessories) are used for emaciated persons. Individual application cases that deviate from this must be co-ordinated with Wissner-Bosserhoff GmbH.

In general the professional judgment of the nursing person responsible (medical supervision) is necessary to guarantee safe use of the nursing home beds. The physical, psychological and medical needs and conditions of patients must be observed. Accordingly the bed functions must be individually released or locked for each patient/resident. This applies particularly to products with special tilting options for the patient surface, and when using side guards.

The maximum working load of the nursing home bed is 225 kg. Higher loads are possible and must be taken from the instructions for use for the respective product! The bed may not be used for patients with a weight of more than 175 kg. The safe working load of 225 kg includes the patient weight, the mattress and the accessories located on the bed (lifting pole, linen etc.)!

46



The operation of nursing home dates is allowed exclusively from mains sockets installed in the building that are up-to-date and that are inspected regularly for the correct function of safety installations (RCD protection, insulation error detectors, power fuse, etc.) in accordance with valid regulations.

The nursing home beds are not protected from explosions and may not be used in application rooms in which fl ammable anaesthetics, cleaning or solvent agents or possible ignitable substances mixed with air and can be found. The regulations of the professional associations must be observed in this respect.

Possible use deviating from this intended purpose represents a non-intended use and is excluded from all claims of liability.

Basic Functions And Uses Of Nursing Home Beds

Modern nursing home beds have numerous bedding functions, which are described in detail in the instructions for use for the respective product. The full benefi ts of a nursing home bed can only be achieved through careful training of the users and inhabitants of a nursing home. Please repeat these training sessions as regularly as possible and pay particular attention to the necessary safety regulations that must be observed.

In general there is always a risk of unintended or wrong adjustment of the bed. For example, pressing switches accidentally or unintended release of functions can be a hazard to certain patients/residents! To ensure a high degree of protection, it is absolutely essential to use locking facilities and/or the release keys selectively. Under no circumstances may release keys remain on the handset or on the bed! Release keys are intended exclusively for use by nursing staff.

The use of the locking facilities and if required, the intentional separation of the bed from the power supply – as an absolute locking measure for the maximum protection of a possibly jeopardised patient/resident– lies exclusively at the discretion of and in the responsibility of the medical supervision and nursing staff in charge. Corresponding measures should be noted in the shift report to guarantee a correct shift handover.

The use of special positions, such as Trendelenburg anti-Trendelenburg, layered bedding or relative lowered head position as a shock position is explicitly allowed only by medical supervision staff. These functions must be locked for patients and residents, since this could otherwise result in hazards.


The safety notes in the specifi c product instructions for use must be observed, since hazards could otherwise occur.

When using the side guards, particular care and caution should be taken: - side guards are used fi rst and foremost to protect the patient from rolling out. On no account may

the side rails be used as a means to hold the patient fi rm. - As soon as the mobility of the patient/resident is restricted, a court order is required to use the

side guards. Only divided side guards or side guards that can be individually lowered, in which only the head and section is assembled, and which can be used as a help in getting in and out, are just one permissible exception for mobile residents/patients here.

Overloading caused by sitting, leaning or pulling on the side rail can result in serious damage to this and cause hazards. It is essential that such overloading is avoided.

When using side guards, their suitability should be checked, taking into account the peculiarities of the respective patient/resident. In particular the clearances between the panels and supports in relation to the body shape of the patient/resident must be taken into account, so that entrapment or slipping through is ruled out. If necessary, additional side guard cushioning must be used which reduces the size of the gap or closes it. This decision is exclusively the responsibility of the medical supervision in charge. The details on the restriction of the intended use in these instructions for use are referred to as an orientation, as well as the specifi c product instructions for use for the bed and for the side rail.

Only side guards may be used on the beds which are also permitted for that particular bed type, since increased risk of accident could otherwise occur.

The side rails/side guards must be checked each time before they are used for possible damage, and checked that they are securely attached to the bed and that the safety lock functions correctly! Details on the correct handling of the side guard can be found in the respective product instructions for use.

The use of the manual remote control by the resident/patient himself lies exclusively at the discretion of and in the responsibility of the medical supervision and nursing staff in charge. Corresponding measures should be noted in the shift report or in the nursing documentation to guarantee a correct shift handover and traceability of usage rights.

If the manual remote control is not to be used by the resident/patient himself, then it must be protected from being accessed by this person and from becoming trapped, for example by attaching it to the foot end of the bed.

48



The manual remote control must not fall on the ground, be subject to heavy weight or have liquids poured on it. It should be cleaned with cleaning cloths used for PC keyboards. If there is damage to the mechanics or from dampness, the remote control must be replaced immediately. The cables must also be checked at frequent regular intervals.

The mains connection cables must be protected from damage during operation and when the bed is transported/moved:

The cable must be safely prevented from being badly twisted, pulled, bent, folded or even squashed. When moving the height adjustment of a bed, make sure that the connection cable is free and can freely follow the movement of the bed at all times. The cable may not be stretched tight. The cable may not become trapped, for example under or behind another item of furniture or under the legs/castors of the bed. Otherwise damage could be caused to the mains supply cable or to parts of the covering. For this purpose, unused mains cable should be folded together in a fi gure of eight loop and held together with a strong rubber band. Alternatively the Wissner-Bosserhoff GmbH mains cable hook can be used. (see following diagrams). Under no account may fi xed cable binders be used, since these could damage the mains cable if it is subject to unintentional tension.


It is essential that the cable is prevented from being dragged across the fl oor or even being squashed or run over with the bed castors when the bed is transported. For this purpose the Wissner-Bosserhoff GmbH mains cable hook can be used. (see following fi gure)

The mains cables must undergo a precautionary visual inspection at brief intervals, for example if mechanical load has been detected, if the cable is relayed or monthly, so that any hazards can be ruled out. The checklist in Appendix A can be used here as a guideline. In particular the critical points of inserting the mains plug, the mains plug cover and protecting the cable from traction or housing openings on the bed must be observed.

USE OF ORIGINAL ACCESSORIES AND RELEASED PRODUCT COMBINATIONS

The use of accessories and combinations of products not authorised for the product can lead to serious hazards. This is why only accessories released by Wissner-Bosserhoff GmbH and products released for combination may be used.

Examples:

Using lifting poles with an insuffi cient diameter can lead to the failure of the lifting pole sockets.

The use of very heavy water mattresses leads to the safe working load being exceeded. This can cause failure of components, including the power units. Hazards arise from this that can lead to accidents.

50



Setting Up The Nursing Home Bed (Safety Clearances) The bed must be set up in such a way that when implementing all adjustment functions of the

bed, collision of bed parts with other objects in the room or with parts of the room is not possible (e.g. mains cable, windowsills, slanting ceilings, pipes, surface-mounted installations, wall boards etc.). A safety clearance from walls and other objects of at least 2.5 cm should be maintained in all possible bed positions when doing this. Caution: Equally no collision may occur for tilting and height adjustments!

Cleaning And Disinfection Of The Bed The nursing home bed must be cleaned and disinfected regularly, and at least before

every change of resident. The nursing home bed may not be cleaned or disinfected in automatic washing units, nor with splash water, jet water or water spray. Only spray and wiping disinfection is permitted.

The following agents are recommended for the disinfection of the nursing home bed, and may only be replaced by equivalent agents: Terralin, Perform and Sagrotan Med (Schülke & Mayr GmbH, Norderstedt). These agents may only be used in accordance with the manufacturer‘s regulations! These refer particularly to the dosage of the agents and possible hazards in combination with other agents.

The wooden linning must not come into contact with these agents. For particularly stubborn stains, commercially available, environmentally friendly all-round household cleaners can of course be used.

No cleaners or cleaning agents may be used, however, that contain mechanically abrasive components and that have the effect of scouring agents.

It must be ensured that no wetness or fl uid stains remain on the real wood and veneer surfaces when in use and when being cleaned. Wood is a natural product which has the property of absorbing moisture, and which expands in doing so. This can cause damage to the surface sealing. Damage to varnished services should be rectifi ed after cleaning with appropriate repair varnish. Pleas ask Wissner-Bosserhoff Customer Service.

Manual remote controls may only be cleaned with cleaning cloths for PC keyboards. If dampness has penetrated, if the unit is heavily soiled or if the keys stick due to dirt particles, the hand controls must be replaced if necessary


Appendix D: Battery Operation (Option) – Additional NotesAs a special fi tting, the bed power unit can be equipped with an additional battery function allowing the bed to be moved multiple times with its electrical functions independently of the mains supply.

The number of adjustments possible depends on the charge status of the battery. To prevent the batteries from excessive discharge, the bed should remain connected to the mains if possible.

Battery charging will then take place fully automatically via a specially integrated PCB.

Normally the battery is delivered fully loaded and mounted on the main power unit; assembly by an untrained operator is not intended.

Important features

• The battery is maintenance-free• Permanently installed in the connection box• Lead gel battery – can be operated irrespective of its location• Nominal data: 24V, 1.2Ah• Lifetime of battery: at least 5 years• Disposal permitted only at special collection points

For safety reasons the battery box must not be opened.

If you want to acquire the battery later on, we urge you to contact Technical Customer Service, since not every power unit is suitable for combination with the battery. Replacement of the battery box should only be performed by trained personnel to avoid possible damage through incorrect handling.

The lifetime of the battery is strongly dependent on usage and on the fact that possible harmful excessive discharge may have occurred.

It is also possible to use a fourfold external charging unit (accessory for parallel charging of four battery boxes), which can be obtained separately: We strongly urge you to observe the separate instructions for use for the battery charging unit in such a case.

52



PO Box 82 Bentley WA 6982

T 08 9351 7500 F 08 9350 5299

[email protected]

www.unicarehealth.com.au

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