MMO 5000 and 5000 + User and Technical Manual - Parts List Ver 3.2 May 2016

Summary

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1

Symbols

4

2

Intended Use Of Bed

5

3 3.1 3.1.2 3.2 3.3 3.3.1 3.4 3.5

General Information General precautions for use Potential Risk of Entrapment Transport and storage Installation and commissioning Label Identifications Warranty terms / After Sales Service Certified Characteristics

5 6-7 8-9 10 10 11 12 12

4 4.1 4.2

General Cleaning Of Bed Recommendation Procedures

12 12 13-15

5 5.1 5.2 5.3 5.3.2 5.4 5.5

Bed Features Symbols & pictograms on remote control Accessories Removal of Head/Foot boards Metal tube Head/Foot boards ¾ Side rails Split side rails

16-17 18-19 20 20 20 21 21

6 6.1 6.2 6.3 6.4

Description of Product Dimensions Technical specifications List of parts covered by ISO 60601 Maintenance specification for electronic parts and actuator (LINAK)

22 23 24 25 25-26

7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.3 7.3.1 7.4 7,4.1 7.4.2 7.4.3 7.4.4 7.5 7.6 7.7 7.8 7.9 7,10 7.11 7.12

Use of different product features Variable height Articulation of bed deck Electric backrest Operating the Safety flat position of the bed (without power) Operating CPR function with a patient in bed Electric thigh section and manual calf section Comfort position Storing the bed exit height in electronic memory Chair position – 1 button operation Trendelenburg /reverse Trendelenburg Electric CPR Function Under bed night light Wall protection and position indicator Brakes Transferring patients in the bed Moving the bed Patient restraint Reset Procedure Calibration procedure - loss of variable height position Calibration procedure when overloaded Side rails

26 27 28 28 28 28 29 29 30 30 30 31 31 31 32 32 32 33 33 33 33 34

Summary

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8 8.1 8.1.2 8.1.3 8.2 8.3 8.4 8.5

Accessories Gap filler Flexible holder for hand control Head /Foot board support Side rail padding Patient Lifting Pole IV pole Remote control and hand control holder

35 35 35 35 36 36 36 36

9 9.1 9.2

Warranty & Installation Warranty Installation and commissioning

37 37 38

10 10.1 10.2 10.3

After Sales Service Troubleshooting Conditions of onsite assistance and spare parts supplier Bed identification label

38 38 39 39

11

Exploded view of the bed

40-47

12

Spare Parts List

48

13

Maintenance Guide for Medical Beds

49-51

13.1

Preventative Maintenance

52-54

14 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 14.9 14.10 14.11 14.12

Servicing Troubleshooting, 1st level - Diagnosis Audible Warnings Wiring Diagram Replacement of the patient hand control Replacing the control box Replacing electrical actuator Replacing backrest actuator Replacing thigh section actuator Replacing variable height actuator Replacing castors Replacing CPR cable Replacing a backup battery

55 55-57 58-59 60 60 61 61 61 61 62 62 62 63

15 15.1 15.2 15.3 15.4 15.5

Data Electromagnetic compatibility Disposal at end of product life Earthing Life of the device After sales services demand sheet

63 63-66 66 66 66 67

16

Changes to User/ Service Manual

61

17

Manufacturer Details

62

1 – Symbols Used In This Manual Warning, please read this instruction regarding safety.

Index of waterproof resistance of the electrical components

Protection against electric shock. Type B device according to EN 60 601-1

DC power AC power

250 kg: Symbol for safe working load of 250kg

215 kg: Symbol for maximum patient weight of 215kg (i.e. 35kg for mattresses and accessories)

Device of Class II double insulated

Risk of crushing feet

Risk of crushing hands

Read user manual

Max working load in kg

Dimensions of mattress compatible with the bed

Compliance: Following European Directive No. 93/42/EEC (medical devices). 20/05/2016 DOC 14 21 012

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2 Intended Use of The Bed This bed is designed for use in hospital and nursing homes. It is designed to enable comfortable sleeping and smooth traveling in or out of bed. This bed ensures the best provision of care for both patients and staff. This type of bed is made for use in an environment of class 2 (short term care services or other medical infrastructure). This bed is designed for short term care in medical institutions. Where medical care, medical supervision and control is provided if necessary and where Electro Medical devices used in medical procedures can be provided to help maintain or improve the patient's condition. Such institution are, hospitals, nursing homes for long durations, rehabilitation centres, geriatric centres and other specialised care centres. This bed is intended to be moved only in the patient room for cleaning or for care giving.

3. General Information We hope that this product will give you complete satisfaction. In order to use the bed in the best conditions of safety, we advise you to read this manual before commissioning. Parts of the bed that may come into direct or indirect contact with the tissues, cells or biological fluid of the body are head and footboard as well as protective barriers. This bed meets the requirements of NF EN 150 10993. The mattress used must also meet the requirements of this standard.

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3.1 General Precautions for use The use and handling of a medical bed can cause injury. It is essential that the person who is handling the bed is authorised and trained to use the MMO 5000/5000+. This person must know the consequences of all actions and how not to cause involuntary movements. Any maintenance must be undertaken by qualified personnel. Upon moving the bed in to a designated room, allow sufficient space for the movement of the bed to avoid damaging the surroundings or injuring a person during movement. To avoid risk of fire, when the actuators of the bed are used too intensively, the bed can go into "safe mode" and shutdown. The bed will return to its normal functions after returning to normal temperature. This return to normal may take several hours. Time of usage taken into account for the thermal safety is 10% or 6 minutes use per hour. DANGER: The MMO bed is an electrical device with a risk of electric shock. Personnel using the bed must be authorised and trained on potential risks related to electrical appliances. It is essential to know how the product works to achieve the desired result during handling. It is essential to comply with the use and recommendations described in this manual to ensure the security and integrity of the different users. The bed is not explosion-proof equipment and cannot be used in explosive areas. Motorised or mechanical bed components can cause serious injury. Do not put arms or legs in the side rails. During operation of the bed make sure that there are no obstructions under the bed, this includes persons or pets etc. Adopt special measures for safety during use of bed with confused patients (i.e. bed at lower position, safety mats, protective covers barriers, enhanced surveillance). The side rail should be fully up and locked or fully folded to avoid risk of entrapment. Avoid floor coverings that are not suitable for the bed. WARNING: during the use of the bed with other medical equipment, it is necessary to check compatibility. It is also important to check that the equipment is compatible with the official medical regulations. It is necessary to keep the plug accessible at all times to be able to unplug the bed quickly, in case of emergency. It is necessary to use only MMO accessories

IT IS STRONGLY RECOMMENDED NOT TO: • Smoke in or near the bed • Use the bed for a child under 12 years of age or smaller than 146 cm • Sit on the bed if that section of the bed is not completely flat • Load the bed beyond the safe working load of 250kg, also not to operate under these conditions • Use electric functions permanently or too intensively and without respecting the duty factor of 10% or 6 minutes usage per hour. 20/05/2016 DOC 14 21 012

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IT IS STRONGLY RECOMMENDED NOT TO: • Use accessories that do not come from the manufacturer of without a specific agreement • Pass the power cord into the moving parts of the bed or castor areas (to avoid entrapment or damage) • Use the bed if the power cord is damaged • Clean the bed with water under pressure • To carry out cleaning or maintenance without the bed being unplugged from power supply • Use any electrical functions on the bed if potential presence of flammable gases such as anaesthetic agents etc. • To use the electrical functions of the bed in an surgery operating room • To use the bed if it has a mechanical or electrical malfunction

Ensure that the use of the bed is compatible with the medical condition of the patient. See conditions for use of various functions of the bed in the corresponding chapters. Regular use of the bed with a load greater than the safe working load of 250kg can degrade components prematurely and cause serious failures. Please ensure any power cables are not trailing beneath the bed, especially during transportation of the bed, this could result in damage to the cable.

3.1.2 Potential Risk of Entrapment

The bed has been designed in accordance to ISO 60601 standards to reduce or eliminate risk of entrapment and/or injury.

The space between the floor and the underside of the side rail is approx. 120mm

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The space between the calf section an the leg section is approx. 25mm

The space between bed and bar on the four bar side rail is approx. 25mm

3.1.2 Potential Risk of Entrapment cont.

The space between the underside of the side rail and the floor is approx. 120mm

The space between bed and bar on the four bar side rail is approx. 25mm

The space between the leg section and the foot board is approx. 25mm

The Space between the steer lock and the floor is approx. 25mm (with 100 mm castor fitted)

The space between the mattress retainer and side rail is approx. 25mm

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The Space between the brake pedal and the floor is approx. 25mm (with 100 mm castor fitted)

3.1.2 Potential Risk of Entrapment cont.

The space between head board and side rail is approx. 25mm

The space between the split side rails and the floor is approx. 120mm

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The space between corner of the bed and the floor is approx. 120mm

3.2 Transport and storage The bed is designed to operate at a temperature between 5°C and 40°C. These conditions should be applied during storage and transport. During transportation the deck must be flat, in the low position with all functions locked and the castors braked. The bed should be protected from impact and friction. It should be strapped. Do not use a fork lift truck to maneuverer the bed. The bed must have paddings. Beds should not be stacked on top of each other. There should be no load of any type on the bed during storage. It is recommended after a storage period and before the first use, to leave the bed at room temperature for a set time (approx. 5 hours) before verifying its operational state.

3.3 Installation and Commissioning A new bed arrives with the backrest and accessories dismantled, bed sections securely strapped, packaged in protective wrapping. If the installation is not done by us, please proceed as follows: 1. Remove the protective wrapping and securing straps (red cable ties). 2. Set backrest and accessories (as shown in the corresponding chapters). 3. Check all pin connections are present, that the cables are not pinched and that the power cable is not strained. 4. Connect the power cord (located at the head end of the bed) to the mains power socket. 5. Perform a thorough cleaning of bed before the first use (see Section 4, Cleaning). 6. Upon placing the bed in a room, ensure there is sufficient space to accommodate different movements of the bed and to avoid damaging the environment and/or injuring to patient or caregiver.

Grid Connection: Make sure the power supply complies with the safety standards enforced, especially as the supply voltage is 230V/50Hz + / - 10V and that there is a ground plug. Check that the power plug is properly connected. It is strongly recommended to connect the bed via a protective 30mA RCD ≤ to identify any electrical failure of the product. An equipotential terminal to ground the bed is situated under the deck.

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3.3.1 Label Identifications

Reference label, manufacturer and model

Entrapment Label: risk of crushing feet

Respect 35 cm between wall and board

Dimensions of compatible mattress For 3 bars side rail, mattress max thickness is 17 cm For 4 bars side rail, mattress max thickness 26 cm Width of mattress : 90 cm Length of mattress: 200 cm

Identification of a removable element (side rails)

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Entrapment Label: risk of crushing fingers

3.4 Warranty Terms / After Sales Service Our products are guaranteed for a period of 10 years. Excluded from this warranty are as follows; control box, gas struts, actuators, remote control, hand control, castors, sleep deck. All of these parts are guaranteed for 5 years. A technical team are available 24/7, 365 days a year to advise you, and decide the appropriate response to a problem.

INVALID WARRANTY IN THE FOLLOWING cases: • Disassembly of mechanical or electrical parts of the bed without consultation and approval from the manufacturer • Use of replacement parts that are not supplied by the manufacturer. • Rework on any electrical parts or gas cylinders. • Degradation of coatings or materials from shock, friction and scratches. • Abnormal use of bed, not following the precautions and recommendations which result in degradation of the bed or its environment. • Using cleaning or disinfecting products discouraged by the manufacturer (see chapter 4, Cleaning) • Using washing machine or washing with excessive amount of water or using a pressure jet. • Crushing or cutting the power or the control box cords. • Intensive use of electric bed functions beyond the recommended service interval.

The bed should be installed and put into service according to EMC requirements specified in Chapter 15. Unused connections are sealed to prevent damage from electrostatic discharge. Do not change the configuration of the bed without the permission of the manufacturer. Do not pull at the power cable to remove the plug from the mains power supply. Users (patients and their families) should be informed of safety requirements to comply with when using the bed. The manufacturer, assembler or installer does not consider itself responsible for the effects on safety, reliability and features of the device if the electrical wiring of the building does not comply with the relevant requirements and if the bed is not used in accordance with the instructions for use.

3.5 Certified Characteristics Certified characteristics are safety, electromagnetic compatibility, mechanical safety and fitness for use of the bed and its accessories.

4 General Cleaning of Bed The bed is not designed for automatic cleaning, manual cleaning only

4.1 Recommendations

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Whenever cleaning the bed, it is advisable to follow the following recommendations: • Unplug the bed and lock all functions if the bed is equipped with a battery (if the bed is unplugged, check that the plug does not come into contact with liquids). • Check that electrical connections are secure. • Check that electrical components do not show any signs of wear likely to allow the penetration of liquid. • Do not wash the bed in a wash tunnel, using a water jet or with any sort of pressure equipment. • Avoid saturating areas containing electrical connections or electrical components. • Be sure to carefully dry areas cleaned to avoid any risk of moisture remaining, in particular in the area of electrical connections.

If there is any doubt about the penetration of liquid into the electrics, it is strongly recommended that the bed should not be reconnected to the mains electrical supply and the maintenance department should be advised. • • • • • • •

Clean surfaces with a soft cloth, warm water and a mild detergent/disinfectant (Ideally use the cleaning/disinfection solution recommended by the hospital, following the dilution instructions carefully). The use of abrasive products or materials is forbidden. Products such as petrol, ketonic solvents, concentrated alkali or acid products, chlorine based solvents or dissolvent risk causing permanent damage to the surface. Non-ionic detergents diluted to 5%, bleach diluted to 10%, ammonia based products diluted to 5% may be used. Stains left by coloured substances such as eosin, betadine, etc. as well as food products should be cleaned as quickly as possible so as to avoid the risk of impregnation. For stubborn stains, the use of pure disinfection products is possible locally as long as the necessary precautions are taken. Areas showing traces of cuts or deep scratches should be repaired so as to avoid the risk of infiltration and deterioration of the protective surface.

4.2 Procedure • • • •

Healthcare establishments are divided into sectors in terms of the risk of infection. Frequency and methods of cleaning and disinfection are adapted according to the evaluated risk. The level of infection risk in one room with a patient being cared for is moderate. It is much higher if the patient presents an identifiable infection risk. Cleaning or disinfection of a medical bed, although not in direct contact with the patient and in particular damaged areas, should be cleaned regularly. Certain areas of the bed are more subject to contamination given the frequency of contact with carer’s and patient’s hands. The bed can be broken down into 3 types of area:

High Contamination level • Bars of the head/foot boards. • Side protection devices • Manual and electrical control handles. • Accessories (arm, intravenous stand, urine sac support, etc.) Moderate Contamination level • Bed head/foot boards • Upper surface of the bed • Brake control pedals • Corner protectors Low Contamination level • Metal structure of the bed • Inside surface of the bed • Electric actuators • Castors

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Sources of dirt and contamination of a medical bed in use are: fabric dust coming from the bedding, food residues, ink, antiseptic liquid, vomit, urine, excrement, blood, etc. It is therefore necessary to take 3 types of cleaning/disinfection or bio-cleaning of the bed into consideration. Daily bio-cleaning of the areas of high risk. Bio-cleaning at the start and on the transfer of the patient and as a minimum, every month for high and moderate risk areas. Full bio-cleaning of the bed after the departure of a patient presenting risk of infection and as a minimum, every two months.

Daily Bio-Cleaning Procedure •

This procedure can be carried out with the patient still in the bed, the objective being to ensure good hygiene of the parts regularly in contact with caregivers and/or patients hands.

•

Carefully clean the bars of the head and foot boards, side rails, manual control handles, electric controls handles and their cable, arm, intravenous stand and the urine bag support. Eliminate all traces of dirt apparent on other parts of the bed.

•

Using detergent/disinfectant products does involve some risk. Always wear Personal Protective Equipment (PPE), follow the instructions and avoid mixing products.

Bio-Cleaning Procedure Monthly or on the departure of a patient • • •

This procedure is carried out without a patient in the bed. The objective being to disinfect all parts of the bed that regularly come into contact with hands, as well as areas dirtied by liquid deposits, secretions, dust and food residue etc. Use a swab and the detergent/disinfectant solution approved by the establishment. Put the bed in the flat position and the bed base at the pelvis height (using the neutral position control if the bed has one), unplug the bed and lock all electrical functions, unlock the brake, move the bed away from the wall to give access all around the bed, then reapply the brake.

Cleaning the bottom part of the bed: • The foot board, cross-member taking the foot board, all stops, caregivers control and the tidy tray. • Lift one half of the mattress and fold over the other part, clean the upper surface of the bed as well as the sides, then underside of the mattress and fold it. Carry out the same procedure for the other half. • Clean the top of the mattress, electric control unit handle and cable, orange handles and urine bag supports on either side. Cleaning the top part of the bed: • The bed head, cross-member taking the head board, all stops, arms, and the intravenous stand. • Unlock the brakes, reposition the bed against the wall, lock the brakes again and clean the brake control bar. • Reconnect the bed and unlock the electrical functions.

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Full Bio-Cleaning Procedure for the bed • This operation is carried out without the patient in the bed. The objective is to disinfect the whole bed after it has been occupied by a contaminated patient or periodically every two months. • This operation should also be carried out before first using the bed • Use a swab and the detergent/disinfectant solution approved by the establishment. • Remove the mattress, various plastic parts of the bed (warning: the central part protects the power supply unit, its connections and two sensors) and the head/foot rests. • Adjust the bed base to pelvis height and raise all the hinged sections using the control handle. Unplug the bed and lock all the electrical functions, unlock the brake, move the bed away from the wall to give access all around the bed and reapply the brake. Cleaning the bottom part of the bed: • The cross-member taking the foot board, all stops, caregivers control, tidy tray, and bed extension. • Clean the curved tubes that make up the bed, bed base, grey power supply unit (be careful not to disturb the sensor settings or disconnect any cables), grey sheathing, electric actuators, orange handles, urine bag support, control unit and cables. Cleaning the upper part of the bed: • • • • • • •

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The head rest, the cross-member that takes the head rest, the stops, the arm and the intravenous stand. Clean the bed chassis, elevation arms, castors, base cover and the wall stop. Clean both surfaces of the various plastic parts of the bed base and put them back in place (be careful to make sure they are positioned correctly on the curved tubing). Clean the head/foot boards and reposition them on the bed. Unlock the brakes, reposition the bed against the wall, lock the brakes and clean the brake control bar. Reconnect the bed to the mains power supply, unlock the electrical functions and return the bed to the flat position using the control handle. Clean the mattress and replace it on the bed.

5. Bed Features The bed has a number of features as standard: • Electric or manual backrest with CPR function • Electric or manual thigh section with fixed manual calf section • ¾ Folding siderail - three or four bars (MMO 5000), or split siderail (MMO 5000+) • Hand control, and / or satellite control box and/or caregiver control box at the foot of the bed with or without infrared remote control (Not available in the UK or EIRE). • Castors 100 mm with or without fairing for cleanliness • Bed weight without accessories, with type A boards and side rail : 123 kg • Basic version has straight castors 100mm on head and/ or mono block manual leg section

MMO 5000

7 1 5 4 9 3

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8

Number

Name

1

Backrest

2

Thigh section

3

Calf section

4

Footboard

5

Headboard

6

Steer lock

7

CPR handles

8

Side rail supports

9

Brake pedal

2

8

6

•

Weight of the bed without accessories, with type A head and foot board and split siderails: 132 kg (291 lb)

•

Bed version with split siderail and castor protector for hygiene

3

1

MMO 5000+

2

4 5 Number 1 2 3 4 5

Name

Satellite control box (optional) Split siderail head Split siderail foot Castor protector for castor size 100 mm (optional) Split sideraile handle

Standard version with directional castors 100mm and manual backrest and/or mono block leg rest

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5.1 Symbols & Pictograms on remote control Remote hand control

Hand control with lockout function

Child safety CPR electric Back rest

Back rest

Thigh rest

height Thigh rest

height

Comfort position

Comfort position

Trendelenbourg/ reverse Trendelenbourg

Trendelenbourg

Remote hand control not available in the UK or EIRE

Satellite Hand Control Backrest

Thigh

Height UP/DOWN

Under bed light

Control panel at the foot of the bed for caregiver with central lockout Backrest

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Height UP/DOWN

Thigh

Comfort Chair position

Trendelenburg/ reverse Trendelenburg

Battery LED

Under bed light

Lockout

Lockout

CPR electric

Set Patient exit height

NOTE: The wireless remote control is universal. It allows controlling of all MMO 5000 or MMO 5000/+ that are equipped with an infrared receiver. The use of two different types of remote control is also possible on the same bed. (Not available in the UK or EIRE).

Caution: Do not use wireless remote control in rooms with more than one bed fitted with a infrared receiver. If wireless remote control is operated with 2 or more beds within the same room, this will result in all the beds simultaneously operating at the same time. This may presents a risk to other patient. For proper operation of the remote no obstacle must interfere with the infrared receiver located at he head section of the bed. For use, aim the remote control toward the head section direction, then select the desired function. (Not available in the UK or EIRE). The hand control has a manually selective lockout function allowing you to independently lock any function of the bed. Warning: for irregularly monitored patients, it is advisable to leave the bed in a low position to reduce the risk of injury in case of falls. Under certain circumstances it may be necessary to prevent operation of the bed controls, therefore we recommend you use the lockout functions. To selectively disable bed functions on the handset: use key supplied, engage key in desired lock location point. Turn clockwise to lock desired function. Turn anti-clockwise to unlock.

Key

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The manual lockout on the patient handset can be overridden by the caregiver handset, but not vice-versa. This allows the patient to control certain function of the bed but not all. Warning: for irregularly monitored patients, it is advisable to leave the bed in a low position to reduce the risk of injury in case of falls.

Example : Backrest + Lock

5.2 Accessories MMO beds are equipped with sockets for accessories: • 2 x sockets for patient helper between the headboard and backrest. • 4 x sockets for IV pole located at the head and foot section of the bed (2 at head section and 2 at foot section) These sockets are designed for the accessories from the manufacturer. The use of non-approved accessories may result in increased emissions or reduced immunity of the equipment. A list of approved accessories is included in the user manual.

5.3 Removal of head/foot board

Socket for accessories

Patient helper socket

The plastic head and foot boards can be removed. To remove, grab the board with 2 hands and pull upward (fig.1). To fit to the bed, engage rods at the bottom of the board into the socket on the frame (Fig.2) and press until it stops.

For some patient conditions, permanently fixing the boards to the bed frame is necessary. A set of screws can provided for that purpose.

Fig 1

5.3.2 Metal tube head and foot board The head board is to be used like the plastic board, the foot board is fixed with knurled knobs.

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