Opera 3ft Low Classic Profiling Bed Installation Guide
- June 9, 2024
- opera
Table of Contents
- Explanations of Symbols
- Installation and Commissioning
- Before you begin, you will also need:
- Remove the Mattress Platforms
- Bed Operation and Maintenance
- Troubleshooting
- Safety Instructions
- General Information
- Servicing
- Technical Specifications
- Service Life and Disposal
- Guarantee
- Opera Warranty Terms and Conditions
- Documents / Resources
3ft Low Classic Profiling Bed Installation Guide
Explanations of Symbols
| Read information with this symbol carefully and urgently follow
instructions. This information is safety-relevant.
---|---
| This symbol indicates hazards due to electrical voltage. There is mortal
danger!
| This symbol indicates general hazards. There is danger to life and health.
| Conformity mark in accordance with the Medical Device Directives 93/42
EEC.
| The electrical equipment is splash-proof.
| Symbol for Protection Class II device, double shock-proof.
| Symbol for type B device according to DIN EN 60601-1.
| This care bed may only be used indoors.
| This product must be disposed of in a separate refuse collection in
the European Union. Do not dispose of as normal domestic waste.
| Symbol for direct current.
| Symbol for alternating current.
| Maximum permissible load.
| Maximum patient weight.
| Read instructions.
Installation and Commissioning
- These items are already fitted to the Head/Foot Board
** These items are already fitted to the Mattress Platform Sections
Please note that styles may vary depending upon purchase.
(D) Mattress Backrest Platform x 1
N.B. Easily identifiable because it has both an actuator and the black control
box.| (E) Mattress Legrest Platform x 1
N.B. Easily identifiable because it only has one actuator.
---|---
Before you begin, you will also need:
- Wall space with a plug socket nearby.
- Tools: 4mm & 6mm Allen Key, A cross head screw driver, Pair of scissors.
Read before you begin!
We recommend that two people install and unpack this bed to avoid injury –
Observe the general manual handling guidelines.
1. Position the Bed
Move the bed into the centre of the room and remove the packaging from the
bed.
Place the side rail box to one side.
2. Place Accessories to One Side
Detach the following accessories and place to one side.
(H) Side Rail End Caps x 8
Remove the Mattress Platforms
With two people, carefully hold the backrest mattress platform (D) at both
ends and pull it up and out of the transport bracket. Carefully place to one
side with the actuator on top (1). Repeat these steps to remove the leg rest
mattress platform (E) from the transport bracket.
Attention: The mattress platforms are heavy, please observe the general
rules of manual handling to prevent strain and injury.
1 Mattress platform lifted out of the transport bracket.| 2 Mattress platforms
removed from transport bracket.
---|---
3 Mattress backrest platform facing up.
4. Position the Head/Footboards
Move the head/footboards over towards a wall. Position so that one of the
head/footboards is placed against the wall (this will become the headboard).
Apply the brakes on the two castors of the headboard. Push down on the brake
pedal to brake/lock the castors.
5. Detach the Transport Bracket
Release the two securing bolts (2) on the transport bracket by pulling out the
bolt (as per the photos below). The securing bolts are on the inside frame of
the head/footboards, with one at each side.
6. Detach the Head and Footboards
With two hands at either side of the board (the one that is not against the
wall) carefully lift it up and out of the transport bracket. Place this to one
side, this will become the footboard of the bed.
Repeat the steps above to remove the headboard, place the headboard against
the wall and place the detached transport bracket to one side.
Transport Bracket with Footboard Removed
7. Secure the Actuator Motors
Lay down the mattress leg rest platform (E) with the actuator motor facing
upwards (3).
On the actuator securing bracket (4) pull back the metal guard and remove the
pin (5). Align the holes in the actuator to the bracket (this is where the pin
was). Insert the pin through the holes and pull the metal guard back over the
pin to secure the actuator in place. Repeat for the mattress backrest
platform.
8. Attach the Headboard to the Backrest
Place the mattress backrest platform (D) down in front of that headrest (A).
Slide the metal prongs (with the two holes in) on the mattress platform side
channels of the mattress backrest platform (D) into the metal plates on the
headboard (as per the photos below).
Secure the headboard to the mattress backrest platform with the securing
bolts. Push the securing bolts back through the headboards metal prongs and
into the mattress backrest platform prongs.
1 | Mattress backrest platform lined up to headboard.| 2 | Mattress backrest
platform side channels lined up to the headboard.
---|---
3 | Mattress backrest platform and headboard secured by securing bolt.| 4 |
Securing bolt securing the mattress backrest platform to the headboard.
9. Connect the Mattress Platforms
Feed the metal prongs on the mattress backrest platform (D) into the mattress
platform side channels of the mattress leggiest platform (E) until the
platforms are joined.
Make sure that the actuator on the mattress largest platform is at the centre
of the bed, located near the control box (circled).
Secure the platforms together by tightening the black thumb screws (C) on the
mattress largest platform (see photos below).
1 | Backrest platform lined up with the mattress largest platform.| 2 |
Backrest platform inserted into the mattress largest platform.
---|---
3 | Thumb screw tightened.| 4 | Loose thumb screws on the mattress largest
platform.
10. Attach the Footboard
Follow step 7 to attach the footboard to the end of the mattress largest
platform.
11. Remove the Cable Ties
Using a pair of scissors, carefully remove the cable ties from the actuator
motors, handset and the mattress platform. Be careful, ensure that no wires
are cut or damaged.
12. Plug in the Actuators
Lift the backrest profiling section fully up, this should remain upright
without support, giving you access to the control box.
Remove the control box cover with a cross head screwdriver.
Plug in all four actuator cables into the correct color coded sockets (as per
the photo below), plug the handset control in and replace the control box
cover.
1 | Backrest platform lifted up.| 2 | Control box under the bed platform.
---|---
3 | Control box with cover attached.| 4 | Control box with actuators plugged
in.
13. Fit the Side Rail End Caps
Unpack the side rails (B) from their box. Lay all four side rails on the
floor.
Fit the plastic end caps (H) to both ends of the individual side rails. To do
this use the bottom of the side rail as a leading edge and push on the cap
(see photo below).
14. Fit the Side Rails to the Headboard
At the head of the bed, press down on the triangular latch in the side rail
runner channel to release the side rail runner (circled in photo 3).
Fit the wooden side rails onto the side rail runner by sliding the rail
runners (I) all the way into the side rail end caps (H) and into the wood of
the side rails (B). The side rail runners go into the top and bottom holes of
the side rail end caps.
1 | Side rail runners lined up with side rail.| 2 | Side rail runners inserted
into side rail.
---|---
3 | Side rail attached to headboard.
15. Fit the Side Rails to the Footboard
Release the black securing bolts that secure the footboard to the mattress
largest platform and pull the footboard slightly away (as per the photos
below).
Repeat step 14 to fit the side rails to the footboard.
Slide the footboard back into the mattress platform mounting channels and
secure with the black securing bolts.
1 Securing bolt released and footboard pulled away.| 2 Side rail runners
inserted into side rail.
---|---
3 Footboard secured to mattress leggiest platform.| 4 Side rails attached.
16. Secure the Side Rail Channels
Tighten the side rail channel fixing bolts (circled) with a cross head
screwdriver. The fixing bolts go through the bottom of the side rail channels
at both sides of the head and footboards, securing the side rail runners in
place.
To detach the side rails remove the side rail channel fixing bolt, as you
remove the bolt make sure to hold the side rails to prevent them dropping out
onto the floor.
To replace the side rails, slide the runners back into the side rail channels.
The footboard may need to be removed as per step 15 to fit the side rails back
on to the footboard. After replacing the side rails, secure the side rails
with the side rail channel fixing bolts.
Side rail channel fixing bolts circled
17. Clip on the Mattress Retainers
Clip in place the mattress retainers (J), 2 slats down from the top of the
backrest, and 2 slats up from the bottom of the leg rest. Repeat for the other
side of the bed.
18. Test Functions
To test that the controls on the bed are working correctly, perform the
following steps:
I. Test the height adjustment
II. Test the backrest elevation
III. Test the largest elevation
IV. Test the tilt feature
V. Test the tilt feature in the opposite direction
VI. Test that the bed lowers into its lowest position
Please refer to page 21 on how to use the handset to perform the above tests.
Attention: Ensure that there are no cables caught when adjusting the bed
height.
Before lowering the bed check that the area underneath is clear, any
obstructions could damage the bed.
19. Position the Bed
Move the bed into the desired position and plug into a mains socket (unbroke
the castors before moving). Position the bed and apply the brakes to the
castors.
Place the mattress onto the bed, make sure that the mattress is secure and all
mattress holders are in place.
20. Confirm Compliance
Mattresses used with the Opera Classic Profiling Beds must meet the following
requirements:
- The side rail height from the top of the mattress in an uncompressed condition and top edge of the upper side rail must be a minimum of 220mm.
- The mattress must meet the requirements outlined in the technical specifications.
Bed Operation and Maintenance
3.1 Overview
- Headboard with integrated height adjustment
- Footboard with integrated height adjustment
- Electrically adjustable backrest
- Electrically adjustable legrest
- Mechanically adjustable legrest
- Handset with locking key
- Backrest actuator
- Legrest actuator
- Control box
- Height adjustment actuator for headboard
- Height adjustment actuator for footboard
- Mains power coiled cable with SMPS power supply box and plug
- Mattress holder
- Side rails
- Side rail channel and runner
- Brake able castors
3.2 Handset with Locking Function
The motorized bed functions can be operated via the handset. All functions can
be locked with the nurses’ key.
To avoid damage, the handset should always be hung up (e.g. on the mattress
base or side rail) when not in use.
Attention: Press only one button at a time, pressing multiple buttons at
one time, may overload and damage the system.
3.3 Tilt Function
Caution: Risk of Fatal Injury
Using the tilt feature can have fatal effects on the user if they are
sensitive to increased blood pressure in the upper part of their body.
The following points are guidance for the tilt function:
- Only medically trained persons must operate the tilt function.
- A medical evaluation must be performed prior to tilting the bed with the users upper body positioned below their heart.
3.4 Locking Function
All electric adjustment functions can be locked by using the nurses’ key (the
blue key).
To lock the adjusting functions, insert the nurses’ key into the locking
device and turn the key so that the locked padlock setting is selected (see
photos above).
The switching positions I and II are testing settings, used to check the
safety of the bed during annual inspections, after repair work or each time
the bed is put into storage. Please refer to page 36 for further information.
3.5 Operation of the Side Rails
To use the side rails, lift the upper side rail until it locks into place in
its highest position.
To lower the side rails, lift the upper side rail and at the same time push
the triangular release catch in the side rail runner (circled) and lower the
side rails down carefully.
The side rails are designed to only prevent the occupant from falling out of
the bed. Leaning or climbing on the side rail may result in injury.
When the side rails are in their highest position, ensure that they are securely locked into place, failing to do this may result in injury.
3.6 Operation of the Castors
All castors on the bed can be braked, to brake the castors push down on the
brake peddle. The castors must always be in the braked position during normal
operation.
The brakes must only be released to move the bed into a new position. The bed is not intended to be used to transport occupants, doing so may result in injury.
3.7 Electric Emergency Lowering
The power supply unit fitted on the bed frame is equipped with a 9V block
battery. This makes it possible to make a CPR emergency lowering in accordance
with EN 60601- 2-52 in the event of a power failure.
Please note that CPR emergency lowering is limited to one time per 9V battery
and should be replaced after an emergency lowering. If the battery is not used
in a two year period, it should be replaced. Replace the battery with a 9V
type 6LR61 alkaline battery.
3.8 9V Battery Change
To replace, check or remove the 9V battery, open the battery compartment on
the power supply unit, this is attached to the headrest motor.
Follow the below instructions to carry out a battery change:
-
Turn off the power supply and unplug the mains plug, failure to do this may result in electric shock and injury.
-
Take off the control box cover by removing the two screws with a cross head screw driver.
-
Carefully pull out the battery holder and replace the 9V battery with a new one.
Connect the new battery and slide the battery holder back into the control box. -
Replace the cover and secure.
3.9 Adjusting the Knee Break Angle
To adjust the knee break angle manually, follow the below steps:
- Use the handset to adjust the knee break angle electronically (see the handset controls on page 21).
- To further alter the knee break angle, lift the footrest section up. Audible clicks confirm when the platform is locked into a new position.
- To lower the footrest section manually, lift it to its highest position and then slowly lower it back down.
To allow the occupant of the care bed to electronically adjust the knee break angle further, carry out the following steps:
- Manually lift the footrest section up by three clicks. Using the handset, lower the knee break angle back down to its flat position. Use the handset to raise the knee break angle back up. This will allow the occupant to further adjust the knee break angle with the handset.
Troubleshooting
Fault | Possible cause | Remedy |
---|---|---|
No response | Mains plug not plugged in | Insert the mains plug into a mains |
socket
Locking function on the handset has been activated| Unlock the handset (see
page 34 on how to do this)
Handset not plugged in| Insert the handset plug into the correct control box
socket
Actuator motor/s not plugged in| Plug actuator motor/s into the correct
control box socket/s
Handset functions do not perform the correct actions| Actuator motor cables in
the wrong sockets on the control box| Ensure the color coded plugs match the
correct color on the socket*
No function after power failure| 9V block battery is discharged| Replace the
9V block battery (See page 21 on how to do this)
Bed moves very slowly| Bed only adjusted via the battery. Mains plug not
plugged in| Plug in mains plug and replace the 9V block
battery as a precaution (See page 19 on how to do this)
- The control box is located underneath the mattress platform
Safety Instructions
5.1 General Safety Instructions
**** During the briefing, specific attention must be drawn to any potential
dangers. Prior to the first use, the Instruction Manual must be read
conscientiously and in detail by the user / care personnel.
Any incidents or issues must be reported to Opera at,
support@operabeds.com.
When operating the adjusting functions, there must not be any objects or limbs
in the movement paths of the bed due to the risk of entrapment and crushing.
Do not sit on the leg section of the bed when operating the raise function.
Ensure that children cannot operate the control system and check if pets are
under the bed before operating any of the functions. Never store anything
under the bed.
If the physical or mental state of the patient requires, the handset can be
locked on the reverse side of the handset when not in use (nurse’s key). See
detailed description of the locking operation in section 3.3 (it may be
advisable to keep the handset out of reach of such a patient to avoid the risk
of strangulation with the handset cord).
Adjustments to the bed must only be carried out by suitably instructed persons
or in the presence of an instructed person.
The side rails have been designed in accordance with IEC 606012-52 to reduce
entrapment risks and falls.
When the side rails are used, the following instructions must be adhered to,
to ensure compliance with IEC 60601-2-52:
- Use only approved side rails supplied as an option by Opera.
- Only suitably instructed personnel are allowed to operate the side rails.
- Lower the side rails slowly and take care not to let them drop down.
- When operating the adjusting functions, the patient’s limbs must not protrude beyond the mattress base or touch the side rails.
- The side rails are only designed to prevent a person falling out of the bed; under no circumstances should they be climbed or leaned on.
- The side rails only provide protection against rolling out of the care bed if the backrest and lower leg adjustments are in the horizontal position.
- The side rail height from the top of the mattress in uncompressed condition must be at least 220mm. If the height is less than 220mm, increase the side rail height with an extension side rail kit.
- During use, ensure that the side rails are level.
- Do not allow children to use the side rails, this may result in entrapment, injury and/or asphyxiation.
- Exercise caution when using the side rails with a disabled occupant, always conduct a risk assessment to ensure that the side rails are suitable for use.
Disconnect the mains plug from the socket before moving the bed, and take care
to avoid dragging the mains plug across the floor when moving the bed.
The mains plug must always remain accessible to enable immediate cut-off by
unplugging the mains plug from the wall socket in case of emergency.
The mains cable must be free and not caught up in anything, as it gets carried
along when the bed height is adjusted, the mains plug may be pulled out of its
socket and electric leads exposed as a result.
If the mains cable or the mains plug are damaged, the relevant part must be
replaced. This work should only be carried out by the manufacturer or
authorised professionals.
When connecting the mains plug, do not use multiple sockets since liquids may
penetrate into the sockets causing a fire hazard and a possible electric
shock.
Before cleaning and disinfection, the mains plug must be disconnected and hung
up safely. Plugs for the handset and the motors which are inserted into the
mattress base, control box and motor unit must remain plugged in. This is
necessary to prevent water ingress into the control box.
When the bed is stationary, the castors must always be in the braked position.
If the castors are not in the braked position, the bed can move when the
occupant gets in and out of the bed, since the occupant uses the bed for
support. Injury can result if the care bed rolls away.
In order to move the care bed, the brakes on all four castors must be released
and the mattress base be adjusted to the lowest horizontal position.
The maximum duty cycle and the safe working load must not be exceeded,
otherwise safe operation cannot be guaranteed (please refer to Technical
Data).
Do not exceed the maximum weight limitation of the care bed. The maximum safe
working load (SWL) is 220kg/34st 6lb for the Opera Classic Profiling Bed and
Opera Classic Low Profiling Bed.
The bed must only be taken apart if there is no patient or occupant in it.
The bed must not be used in rooms where there is a risk of explosion.
5.2 Safety Information for the Operator
With the help of this Instruction Manual, instruct each user in the safe
operation of the care bed before it is put into service for the first time.
Advise the user of any hazards which may occur if not handled correctly.
Only persons who have been properly instructed may operate the bed. This also
applies for persons who only operate the care bed on a temporary basis.
The bed outlined in this manual is a Class I Medical Device as defined by the
Medical Device Directive 93/42/EEC.
Please observe your obligations as the operator, see section 7.1.
5.3 Safety Information for the User
Ensure that the operator instructs you in the safe operation of this bed.
In addition, pay particular attention to the general safety information laid
out in Section 5.1.
Adjustments of the bed must only be carried out by suitably instructed persons
or in the presence of an instructed person.
Make sure that the mattress base has travelled to its lowest position before
leaving the patient unattended. This will minimise the risk of injury to the
patient when getting in or out of bed.
If there is a suspected fault or damage, disconnect the mains plug from the
socket. Clearly mark the care bed as “Out of Order” and take it immediately
out of service. Then inform the person responsible for the bed immediately.
5.4 Cleaning and Disinfection
Before cleaning and disinfection, the mains plug must be disconnected and
hung up safely. Plugs for the handset and the motors that are plugged into the
control box must remain in their sockets. This is necessary to prevent water
from getting into the control system.
Do not immerse electrical components in water but wipe them with a damp cloth.
The electrical components must not be cleaned with a high pressure cleaner or
a water jet. Only disinfection by wiping is permitted.
Attention: In the event of disinfection by large scale spraying with
products containing alcohol, there is a danger of explosion and fire.
5.5 Servicing and Maintenance
Servicing work must only be carried out by persons who have at least read the
safety regulations and are qualified to the MPBetreibV (Operators of Medical
Products Ordinance) § 4 and 6.
A technical check and/or safety inspection must be conducted at least once a
year, after a lengthy break in use and before each further use. Refer to
section 7.1. Any defects, damage or signs of wear must be rectified without
delay. Only original spare parts from Opera may be used, otherwise all
guarantees or warranties will be excluded.
Please check all fixings on your bed at least once a month. Pay special
attention to side rail components and mattress platform connections.
The 9V block battery is the energy store for electrical emergency lowering in
the event of a power failure. The energy store is sufficient for one emergency
lowering and must then be replaced. If the expiry date of the battery has
passed it must be replaced. Since batteries are subject to self-discharging,
it is recommended to use a 6LR61 alkaline manganese battery and to replace it
every two years. Used batteries must be disposed of in an environmentally
compatible way, contact your local waste recycling facility for further
details.
5.6 Accessories
The optional accessories available include a patients lifting pole (product
code: BOA011) of which the safe working load is 80kg and must not be exceeded.
The patients lifting pole may only be used within its admissible adjusting
range which is defined by the sleeve on the bed. Otherwise the bed may tip up,
resulting in serious injury.
Only the supplied side rails (BOA003) can be used with the Opera Classic
Profiling Beds, please see the specifications for further details on the side
rails.
Use only mattresses compatible with the supplier side rails. The dimension
between upper surface in an uncompressed condition and the top edge of the
upper side rail must be 220mm minimum. If the dimension is less than 220mm,
an extension side rail kit should be fitted.
5.7 Electromagnetic Compatibility
Regarding their emitted interference and interference resistance, the electric
motor units comply with the requirements of EN 60601-1-2:2007 (see section
8.8). However it is possible that electrical devices can interfere with each
other. In this case, switch off the bed for a short time or remove the
interference source.
5.8 Storage
If the care bed is stored for a lengthy period, the 9V block battery should be
removed as it will be subject to a higher rate of self-discharge. The bed
should be stored between -10°C to 60°C in a room with a relative humidity
between 30% to 75%. Keep the bed dry and out of direct sunlight.
5.9 Service Life and Disposal
The normal service life for care beds in domestic use is approximately 5
years.
Please refer to chapter 9 for further instructions.
General Information
6.1 Definitions of Users
Operator
An operator is any natural or legal person who uses the care bed or on whose
instruction it is used (e.g. nursing homes, specialized retailers, health
insurance companies and medical product suppliers).
Users
Users are persons who as a result of their vocational training, experience or
briefing are authorised to operate the care bed, carry out work on it, or are
instructed in handling the bed. Furthermore, they recognize and avoid
potential dangers and assess the clinical condition of the patient.
Patient / Occupant
Persons in need of care; handicapped or infirm; and occupying a care bed.
Qualified Personnel
Qualified personnel are employees of the operator, who as a result of their
vocational training or briefing, are entitled to deliver, assemble,
disassemble and transport the care bed. In addition, these persons are
instructed in the cleaning and disinfection regulations for the care bed.
6.2 General Notice
Clean and disinfect the care bed before using it for the first time. Please
note that the various safety instructions must be observed. Refer to Chapter
5.4 on how to clean and care for the bed.
Opera Beds bear the CE mark and meet all general safety and performance
requirements. The beds have been tested in accordance with international
standards.
The safety and performance requirements can only be met if the user uses the
care bed as outlined in this manual.
6.3 Intended Use
The Opera Classic Profiling Beds (enclosed and unenclosed variants) and the
Classic Low Beds (enclosed and unenclosed variants) are intended for
accommodating occupants in residential homes, nursing homes and the domestic
environment. The care beds may only be used under the conditions for use
described in this Instruction Manual.
The Opera Classic Profiling Beds and Classic Low Beds are designed to
accommodate adults weighing up to 185kg/29st 1lb.
The beds are intended to be used for occupants who have a condition where care
from the bed is required, this may be to alleviate or compensate for handicaps
and/or disabilities and to facilitate the working conditions of the carer.
Any other use shall be regarded as non-compliant with the intended uses. This
will void the warranty terms and conditions.
Under certain conditions the care beds may be used with other medical devices,
such as antidecubitus/pressure relieving mattresses, aerators and alimentation
systems. Always conduct a risk assessment when using the bed with
accessories, equipment and other medical devices.
The mattress must meet the technical specifications and requirements outlined
in Sections 5 and 8.
If electrical devices are used in the care bed and/or near the care bed, a
risk assessment must be conducted and measures taken to ensure that any cables
do not interfere with the bed.
6.4 Non-Intended Use
A non-intended use is a use that deviates from the intended purpose.
Non-intended uses include, but are not limited to the following:
- Loading the care bed beyond the safe admissible working load (refer to specifications in Section 8).
- Operation of the care bed by occupants who have not been instructed on its use.
- Use of the care bed for children.
- Attempting to move the care bed when in its braked position.
- Using the care bed for transporting occupants.
- Use of the care bed on a non-horizontal surface (max incline of 5°).
- Use as a hospital bed or in hospitals.
- Use with electrical applications which involve intravascular or intracardiac processes with the occupant.
- Use with any devices that will compromise the general safety and performance requirements of the care beds.
Using the care beds for any of the above uses or a use that is not outlined in this instruction manual will be regarded as a non-intended, this will void the warranty terms and conditions.
6.5 General Regulations
The care beds must only be used for the purpose intended. When setting up,
operating and using the care bed, respect the regulations in your country, the
general recognised rules of technology, the occupational health and safety,
and accident prevention regulations.
If the care bed is faulty, operation must not be stated. Any issues or
incidents must be reported to Opera Beds. Please refer to the back cover for
contact details.
6.6 Qualification of Users
The care bed must only be operated by persons who have the corresponding
training or experience to enable them to handle the care bed correctly.
Servicing
Operators of care beds are obliged to conform to servicing regulations in your
country.
The test according to the regulation EN 62353 contains the following minimum
requirements:
- Visual checks
- Functional tests
- Overall evaluation
A visual and functional test, including an electrical test must be carried out
at least once a year. For this purpose, proceed according to the technical
safety checklist as per regulation EN 62353.
Important: If you have any doubts about the safety or functioning of the
care bed or a component as a result of the checks performed below, the bed
should under no circumstances be placed into service again. Contact Opera
when there is any uncertainty.
7.1 Technical Safety Checks According to EN 62353
Care Bed: ………………………………………………………………………………………………………………..
Serial No.: ………………………………………………………………………………………………………………..
Location: …………………………………………………………………………………………………………………
Person Responsible: ………………………………………………………………………………………………
Inspected by: …………………………………………………………………………………………………………
Item | Instruction for Testing | Comment | Yes | No |
---|---|---|---|---|
1. | Is the general condition ok? | |||
2. | Are the type plates for the bed and the motors legible? | |||
3. | Is the Instruction Manual available to staff? | |||
4. | Is the use one for which it was intended and is it safe? | |||
5. | No surface damage or corrosion? | |||
6. | Mechanical components and welded joints without faults? | |||
7. | Are all mechanical connecting elements securely fixed? | |||
8. | Mattress base underside undamaged? | |||
9. | Can all adjustment options for the bed be operated without hindrance on | |||
site? | ||||
10. | Is the mechanism for locking the thigh rest in place in working order? | |||
11. | Are the side guard beams free of any fractures, cracks or other damage? | |||
12. | Do the side guard beams sit securely in their anchorage? | |||
13. | Has the load test been carried out successfully according to the | |||
regulations? | ||||
14. | Are the patient’s lifting pole and pole sleeve undamaged without any | |||
signs of wear? | ||||
15. | Do the side rails lock safely into place? | |||
16. | Max. distance between the side rails 120mm? | |||
Item | Instruction for Testing | Comment | Yes | No |
--- | --- | --- | --- | --- |
17. | Height of side rails above the mattress at least 220mm? | |||
18. | Height of side guards above the mattress at least 220mm? | |||
19. | Have castors including locking brake been tested for safe functioning? | |||
20. | Mains cable, connecting cables and handset securely attached? | |||
21. | Fixture available for safe transportation of mains plug? | |||
22. | Strain relief of the mains cable and handset securely attached? | |||
23. | Are all plug-in connections securely attached? (Washers without damage?) | |||
24. | Are cables laid correctly and safely? (No damage) | |||
25. | Motor housing and SMPS housing, mains plug housing without damage? | |||
26. | Are the thrust pipes of the height | |||
adjustment motors undamaged? | ||||
27. | Functional test of the handset: can the buttons be operated properly? | |||
28. | Functional test of handset locking | |||
device: On/Off working correctly? | ||||
29. | Testing of initial fault safety by means of integrated blocking box in | |||
handset. | ||||
30. | 9V block battery ok/expiry date sufficient until next test? | |||
31. | Is the safe working load adhered to? |
Comments: ……………………………………………………………………………………………………………….
Place / Date: ……………………………………………………………………………………………………………
Inspected by: …………………………………………………………………………………………………………..
Next Inspection: ………………………………………………………………………………………………………
Signature: …………………………………………………………………………………………………………………
7.2 Checking the Initial Fault Safety
To check the safety equipment, proceed as follows:
The switching positions I and II are testing settings only used to check the
safety during the annual inspection, after repair work, or each time a bed is
put back into service after being out of service.
-
Select setting switch position 4 (padlock symbol closed). Set all bed adjustments to slightly raised positions.
-
Select setting switch position 3 (padlock symbol closed). When operating the adjustment buttons, no motorized adjustments should be possible.
-
Select the switch on the back of the handset to testing position 1 (symbol
When operating the adjustment buttons no motorized adjustments should be possible. -
Select the switch on the back of the handset to position 2 (symbol II).
When operating the adjustment buttons, no motorized adjustments should be possible.
Technical Specifications
8.1 Technical Data
Measurement | |
---|---|
Specification | Classic |
Max. Weight of
Occupants| 185kg/29st llb
Height Range (Floor to Top of Mattress Platform)| 400- 800mm/16″| – 31″ 220 –
620mm/8.25″ – 23″
External Length| 2180mm/86″
External Width| 1055mm/41.5″
External Height (In
Lowest Position)| 890mm/35″| 815mm/32″
External Height (In
Highest Position)| 1295mm/51″| 1225mm/48.2″
Specification| Classic I Classic Low
---|---
Internal Length| 2000mm/78.7″
Internal Width| 900mm/35.4″
Upper Level of Head Section/Foot Section| 70°, 30
Height Adjustment of Mattress Base (range) from| 400 – 800mm/16″ – 31″| 220 –
620mm/8.25″ – 23″
Backrest Adjustment Adjustable Electronically up to| Approx. 70° (Electric,
Stepless)
Thigh Rest Adjustment Adjustable Electronically up to| Approx. 30° (Electric,
Stepless)
Foot Rest in Raised Position (Raised Mechanically) to| -25° to 0° Degrees in
Five Stages
Mattress Base Surface| Powder-Coated Steel
Wooden Side Guards (with plastic ends)| 1973 X 115 X 28mm (77.8″ X 4.5″ X
1.1″)
Castors with Individual Lockable Brake| 4 of 4
Max. Castor Loading Capacity| 100kg pcs/15st 71b
Operating Noise| < 53 db(A) at a distance of lm
Maximum Mattress Depth| 120mm – 200mm/4.7″ – 7.9″
Recommended Mattress Length| 2000mm/78.7″
Recommended Mattress Width| 870mm to 900mm/35.4″
Backrest Length| 745mm/29.25″
Thigh rest Length| 350mm/13.75″
Largest Length| 540mm/21.25″
Maximum Backrest Angle| Approx. 70°
Maximum Largest Angle| Approx. 30°
Specification| Classic| Classic Low
---|---|---
Safe Working Load – SWL (Max Weight of Patient + Mattress + Accessories)| Max.
Weight of Patient: 185kg/29st 1lb Advisory Weight of Mattress: 20kg/3st 1lb
Advisory Weight of Accessories: 15kg/2st 4lb SWL: 220kg/34st 6lb
| Split Side Rails
Length| 1973mm/77.7”
Height in Lowest and Highest Position| 84mm – 425mm/3.3” – 16.7”
Weight| 11kg for 4 pieces
Safe Working Load (SWL)| 220kg/34st 6lb
8.2 Technical Data (Electrical)
Power Supply Unit | SMPS |
---|---|
Voltage Rating | Input Voltage: 100 – 240V AC and Voltage: 29V DC |
Frequency Rating | 50 – 60Hz |
Type of Current | Input Voltage: AC and Output Voltage: DC |
Nominal Consumption During Operation | Approx. 70W |
Nominal Consumption in Idle State | Approx. 0.5W |
Nominal Operating Time | Max. 2 minutes (Max. 5 Switch Cycles/ Minutes) |
Nominal Idle Time | 18 Minutes |
Primary Safety Fuse | 2A |
Battery for Emergency Lowering | x1 6LR61 |
Mattress Base Motor Units (Back/Leg) | MD125 (Limoss) |
Height Adjustment Motor Unit | MD121 (Limoss) |
Motor Unit Protection Class | III |
8.3 Classification
Medical Device Class (MDD 93/42 EEC) | Class 1 |
---|---|
Degree of protection to DIN EN 60601-2 | Group1, Class B (CISPR11) |
Housing degree of protection to EN 60529 | Power supply unit: IPX6 Motor units: |
IPX4 Control box: IPX6 Hand switch: IPX4
Max. duty rating| max. 2 minutes
Max. switching cycles/mins| max. 5 switch cycles/minutes
Safety inspections| Annually
8.4 Technical Data (Environmental)
Temperature range during operation | +10°C to + 40°C |
---|---|
Temperature range for storage/transport | -10°C to 60°C |
Humidity of the air for storage/transportation | 30% to 75% rel. |
Air pressure for storage/transportation | 700 to 1060 hPa |
8.5 Weights of the Individual Components
Mattress platform – head section | 24kg |
---|---|
Mattress platform – leg section | 20.5kg |
Bed chassis – head section | 27kg |
Bed chassis – leg section | 27kg |
Wooden side rails | Approx 2.8kg each |
Transportation bracket | 5kg |
8.6 Information about Electromagnetic Emissions
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The care bed is intended for use in the electromagnetic environment specified
below. The customer or user of the care bed should ensure that it is used in
such an environment.
Emitted Interference| Compliance| Electromagnetic Environment – Guidelines
RF emissions according to CISPR11| Class 1| The care bed uses RF energy only
for its internal functioning. Therefore the RF emissions are very low and it
is unlikely that nearby electronic devices will be disturbed.
RF emissions according to CISPR11| Class B| The care bed is designed for use
in all establishments including domestic establishments and those determined
to be directly connected to a public supply network that supplies buildings
used for residential purposes.
Emissions of harmonics according to IEC 61000-3-2| Class A|
Emissions of voltage fluctuations/flicker according to IEC 61000-3-3|
Complies|
8.7 Information about Electromagnetic Interference Immunity
Guidance and Manufacturer’s Declarations – Electromagnetic Interference Immunity
The care bed is intended for use in the electromagnetic environment specified
below. The customer or user of the care bed should ensure that it is used in
such an environment.
Interference Immunity Certification| IEC 60601 Test Level| Compliance Level|
Electromagnetic Environment – Guidelines
Electrostatic Discharge (ESD) according to IEC 61000-4-2| ± 6 kV Contact
discharge
± 8 kV Air discharge| ± 6 kV Contact discharge
± 8 kV Air discharge| Floors should be wood, concrete or ceramic tile floors.
If the floor is covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast transients/bursts according to IEC 61000-4-4| ± 2 kV For power
lines
± 1 kV for input and output lines| ± 2 kV For power lines
± 1 kV For input and output lines| The quality of the supply voltage should be
equivalent to that of a typical business or hospital environment.
Surges according to IEC 61000-4-5| ± 1 kV Voltage phase- phase conductor 1 kV
Voltage phase-ground conductor| ± 1 kV Voltage phase-phase conductor”
1 kV Voltage phase- ground conductor| The quality of the supply voltage should
be equivalent to that of a typical business or hospital environment.
Magnetic field of power frequency (50/60Hz) according to IEC 61000-4-8| 3 A/m|
0.3 A/m| Magnetic fields of power supply frequency should comply with the
typical values, as can be found in a business and hospital environment.
Voltage dips, short interruptions and supply voltage variations according to
IEC 61000-4-11| < 5% UT for 1/2 cycle (>95% dip)
40% UT for 5 cyckes (60% dip)
70% UT for 25 cycles (30% dip)
<5% UT for 5s (>95% dip)| <5% UT for 1/2 cycle, 10ms (>95% dip)
40% UT for 5 cycles 100ms (60% dip)
70% UT for 25 cycles 500ms (30% dip)
<5% UT for 5s (>95% dip)| The quality of the supply voltage should be
equivalent to that of a typical business or hospital environment.
If the user of the care bed also requires continued operation during
interruptions in energy supply demands, it is recommended to feed the care bed
from an uninterruptible power supply or a battery.
---|---|---|---
8.8 Information about Non Life Support Devices
Guidance and Manufacturer’s Declarations – Non-Life- Support-Devices Electromagnetic Interference Immunity.
The care bed is intended for use in the electromagnetic environment specified
below. The customer or user of the care bed should ensure that it is used in
such an environment.
Interference Immunity Certification| IEC 60601 Test Level| Compliance Level|
Electromagnetic Environment- Guidelines
Conducted RF interferences according to IEC 61000-4-6
Emitted RF interferences according to IEC 61000-4-3| 3 V eff
150 kHz-80
MHz 3 V/m
80 MHz-2.5 GHz| 3 V eff
3 V/m| Portable and mobile radios, including cables, should not be used closer
to the care bed than the recommended working clearance that is calculated by
the equation for the appropriate frequency.
Where P is the Power of the transmitter in Watts (W) according to
specifications of the transmitter manufacturer and D is the recommended
working clearance in meters.
Field strengths from fixed RF transmitters should, at all frequencies,
accordng to a site survey, a-Note p.5 be lower than the level of agreement be
b- Note.p.5.
In the vincinity of equipment, bearing the following symbol, interference.
Note 1: At 80 and 800 MHz, the higher frequency range must be taken.
Note 2: These guidelines may not apply in all situations. The propagation of
electromagnetic waves is affected by absorption and reflection from
structures, objects and persons.
a) Field strengths from fixed transmitters, such as base stations of mobile
telephones and land mobile radios, amateur radio, AM, FM radio and TV
broadcast can not be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey is recommended. If the field strength at the location of the care
bed exceeds the specified compliance level above then the care bed should be
monitored with respect to its normal operation. If abnormal performance is
observed, it may be necessary to take additional measures, such as reorienting
or relocating the care bed.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.
8.9 Working Clearances between Communications
Recommended working clearances between portable and mobile RF communications equipment and the care bed.
The care bed is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the care bed
can help to prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the care bed as recommended below, according to the maximum
output power of the communication device.
Output Power of Transmitter in Watts (W)| Working clearance according to
transmission frequency (In meters – M)
150 kHz to 80 MHz at 3 V/m| 80 MHz to 800 MHz at 3 V/m| 800 MHz to 2.5 GHz at
3 V/m
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
For transmitters not rated in the list above, the working clearance can be
determined using the equation, which belongs to the transmitter, where P is
the nominal output of the transmitter in Watts (W) according to
specifications of the transmitter manufacturer.
Note 1: An additional factor of 10/3 is applied when calculating the
recommended working clearance between transmitters in the 80 MHz to 2.5 GHz
frequency range in order to reduce the probability that a mobile/portable
communications device unintentionally brought into the patient area could lead
to interference.
Note 2: These guidelines may not apply in all situations. Propagation of
electromagnetic waves is affected by absorption and reflection from
structures, objects and persons.
Service Life and Disposal
**** The service life of the care bed is approximately 5 years. This is dependent upon the manner of use. The care bed is suitable to be put into service again if all measures of Sections 2 and 7 are taken. Frequent transport, setting up and adjustment, reduce the service life, as does improper treatment, irregular servicing and exceeding the safe working load or the admissible load cycle of the electric motors. When the service life has ended, do not dispose as normal domestic waste, please contact your local waste recycling facility for further instructions.
Guarantee
As stated in the Warranty Terms and Conditions, below, Opera provides a manufacturer’s warranty of 3 years from the date of purchase.
Opera Warranty Terms and Conditions
11.1 Warranty Terms
11.1.1 Subject to the terms and conditions set out below, Opera agrees to
repair or replace the product within the United Kingdom at its own cost.
In circumstances where the product does not perform in accordance with Opera’s
specifications during the warranty period of 3 years, commencing on the date
of delivery (or deemed delivery) of the product.
11.1.2 This contractual product warranty does not operate to limit rights
under the statutory warranties referred to in clause 11.3.1 below.
11.2 Warranty Conditions
11.2.1 Proof of purchase (invoice) must be provided when requesting service
under warranty.
11.2.2 Opera requires any customer requesting service under the warranty to
comply with directions from Opera staff in relation to troubleshooting any
issue and facilitating any repair or replacement under these Warranty Terms
and Conditions.
11.2.3 The customer is responsible for inspecting all goods received from
Opera upon arrival. In instances where goods have been damaged in transit, the
customer must report this to Opera within three working days of receipt of
the product. Failure to report physical damage on arrival within three working
days of receipt may result in denial of warranty for physical damage.
11.2.4 Opera reserves the right to replace the product or relevant part with
the same or equivalent product or part, rather than repair it. Where a
replacement is provided, Opera will determine, in its discretion, the closest
product within the current range of products offered by Opera with which to
replace the faulty or damaged product. The replacement product may differ
with the replaced product in size and specifications, at the reasonable
election of Opera. Opera may replace parts with refurbished parts.
Replacement of the product or a part under the warranty does not extend or
restart the warranty period.
11.2.5 If Opera is unable to repair or replace the product, the customer will
be provided with credit for Opera products or may be refunded the price of the
product (at Operas election). This credit or refund will be for the amount of
the purchase price of the product, excluding the associated delivery cost.
11.2.6 In the event that a replacement, refund, or store credit is provided as
per section 11.2.5, the faulty item will become the property of Opera.
11.2.7 Opera may seek reimbursement of any costs incurred by you where the
product is found to be in good working order.
11.2.8 Opera reserves reasonable discretion to determine whether any product
is or is not performing in accordance with Opera specifications, subject to
applicable law.
11.3 General
11.3.1 Legislation may imply warranties or conditions or imposes obligations
on Opera, which cannot be excluded, restricted or modified in relation to
consumer goods.
11.3.2 To the full extent permitted by law, but subject always to clause
11.3.1, the warranty will not apply in respect of a product:
(a) If the product has not been installed, operated, maintained or used in
accordance with the Opera instructions or specifications provided with the
product;
(b) If the factory-applied serial number has been altered or removed from the
product;
(c) To damage, malfunction or failure resulting from alterations, accident,
misuse, abuse, fire, liquid spillage, mis-adjustment of customer controls, use
on an incorrect voltage, power surges and dips, thunderstorm activity, force
majeure, voltage supply problems, tampering or unauthorised repairs by any
persons, use of defective or incompatible accessories, exposure to abnormally
corrosive conditions or entry by any insect, vermin or foreign object in the
product.
(d) To damage arising during transportation, installation or while moving the
product or to any transportation costs of the product or any parts thereof to
and from the customer, unless otherwise specified in these warranty terms and
conditions;
(e) To any third-party software or hardware not contained in the product as
originally configured by Opera.
(f) To any failure, to the extent that the failure is not a failure of the
product to perform in accordance with its specifications.
(g) To service of any product whilst it is outside the United Kingdom.
11.3.3 To the full extent permitted by law, but subject always to clause
11.3.1:
(a) Opera will not be liable for any loss, damage or alterations to third
party products, no matter how occurring; or for any loss or damage arising
from loss of use, loss of profits or revenue, or for any resulting indirect
or consequential loss of damage.
(b) Opera’s aggregate liability in respect of all claims under the warranty
shall not exceed the original purchase price of the product or, at Opera’s
option, the replacement of the product with a like or similar product.
(c) Opera excludes all other warranties, conditions, terms, representations
and undertakings whether express or implied.
Azure House, Connaught Road, Kingswood, Hull, HU7 3AP
0333 222 8584 | support@operabeds.com |
operabeds.com
Version 4 | Published in October 2022
Documents / Resources
|
Opera 3ft Low Classic Profiling
Bed
[pdf] Installation Guide
3ft Low Classic Profiling Bed, 3ft Low, Classic Profiling Bed, Profiling Bed,
Bed
---|---
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>