Arjo Prioma User manual

INSTRUCTIONS FOR USE
Prioma Birthing Bed
PBB-IFU-REV13-020622

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Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
CONTENTS
Page
1. WARNINGS & CAUTIONS 2 - 3
2. INTRODUCTION 4 - 5
2.1 Prioma Birthing Bed Key Features 4
2.2 Product Overview 5
3. CLINICAL APPLICATION 6
3.1 Intended Area of Use 6
3.2 Application Environment 6
3.3 Maximum Patient Weight 6
4. INSTALLATION 7 - 8
4.1 Electricity Supply 7
4.2 Mattress 8
4.3 Mattress and Side Rails 8
5. ELECTRONIC CONTROLS 8 - 9
5.1 Control Handset - Optional 8
5.2 Nurse Side Control Panel 9
5.3 Patient Side Control Panel 9
6. ELECTRONIC CONTROLS DESCRIBED 10 - 12
6.1 Backrest Adjustment 10
6.2 Mattress Platform Height 10
6.3 Tilt Positioning - Trendelenburg / Reverse Trendelenburg 10
6.4 Cardiopulmonary Resuscitation (CPR) 11
6.5 Emergency Trendelenburg (head down tilt) Function 11
6.6 Lock Out Function 11
6.7 Battery Charge Indicator - Battery Backup 11
6.8 Mains Power Indicator 12
6.9 Backrest Angle Indicator 12
6.10 Under Bed Lighting (not Included on any control devices) 12
7. GENERAL OPERATION 13 - 17
7.1 Castor System 13
7.2 Head and Foot Panels 14
7.3 Bed Extension 15
7.4 Manual Cardiopulmonary Resuscitation (CPR) Function 16
7.5 Drop Down Side Rails 17
8. STANDARD ACCESSORIES 18 - 20
8.1 Under Tray 18
8.2 Grab Handle 18
8.3 Footrest Plate 19
8.4 Upper and Lower Leg Supports 19
8.5 Stirrups 20
8.6 Mattress Sections 21
9. POSITIONING EXAMPLES 22
10. BED SPECIFICATIONS 23
11. CLEANING 24
12. MAINTENANCE 25 - 26
13. TROUBLE SHOOTING 27
14. TRANSPORTATION AND STORAGE 27
15. PRODUCT LIFETIME & END OF LIFE DISPOSAL 29
16. BED LABELS AND WARNINGS 30 - 31
17. PRIOMA BIRTHING BED ACCESSORIES 32
18. WARRANTY AND SERVICE 32
19. REGULATORY INFORMATION 32

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1. WARNINGS & CAUTIONS
WARNING
Indicates possible hazard in procedures or conditions which, if not correctly followed,
could result in death, injury, or other serious adverse reactions.
CAUTION
Indicates possible hazard in procedures or conditions which, if not correctly followed,
could result in equipment damage or failure.
Important that this Information for Use Manual is read in its entirety prior to the operation of the
bed. The manual is designed to ensure that users are equipped with the information required to
competently and responsibly operate the bed and its accessories.
It is recommended that the Information for Use Manual be kept in an easily assessable place for
quick reference. If required Arjo product specialists can provide additional training.
All warnings and cautions within this manual should be strictly adhered to. Failure to do so could
result in harm to the patient, or operator.
Warnings highlighted throughout this manual identify possible hazards in procedures or conditions,
which if not followed correctly could result in serious injury or fatality.
Cautions highlighted throughout this manual identify possible hazards in procedures or conditions,
which if not followed correctly could result in equipment damage or failure.
GENERAL WARNINGS
 Electrical equipment can be hazardous if used incorrectly.
 Do not use electrically operated beds in the presence of flammable gases.
 Do not use electrically operated beds in operating theatres.
 Use the bed to support one patient only. The Prioma Birthing Bed is intended for one
person use and may become unstable if used incorrectly.
 It is recommended that the bed be positioned at its lowest height when unattended by
caregivers to minimise the risk of patient injury from falls when getting in and out of the
bed.
 Residual current devices (RCD) are not supplied with the Prioma Birthing Bed. Please
consult with your Biomedical Engineer/advisor concerning RCD requirements.
 The full safe working load (SWL) of the Prioma Birthing Bed is 200Kg with a maximum
patient weight of 135Kg. The 200Kg SWL includes the mass of the patient, mattress and
any accessories fitted to the bed.
 Do not place the handset if fitted, or the power cord across the mattress surface of the
bed. When the bed is not connected to mains power always store the mains power cord
within the power cord fixtures fitted to the bed.
 Do not use accessories that are not designed or approved for use with the Prioma bed.

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1. WARNINGS & CAUTIONS - Continued
GENERAL SAFETY WARNINGS
 Always use the mattress sections designed for use with the Prioma Birthing Bed.
 Before operating the bed make sure that the patient is safely positioned to avoid
entrapment.
 Before transporting the bed make sure the power cable is disconnected from mains power
and stored within the power cord fixtures at the head end of the bed. Adjust the bed to a
suitable height to move without stooping, or straining.
 Always apply the brakes when the bed is stationary.
 When the patient's condition could lead to patient entrapment the mattress support
platform should be left in the flat position whilst unattended.
 The clinically qualified person responsible should consider the age, size and condition of
the patient before using the bed and its accessories.
 Always ensure that all hospital lines and power cables are free from possible
entanglement with mechanical parts of the bed.
 Always ensure that attendant and patient limbs are free from potential entrapment areas
before operating any functions.
WARNING
 Ensure that the patient, care givers and bedside equipment is not positioned to become
either trapped or crushed during bed adjustment.
 Ensure that the power lead is not being stretched.
 Ensure that the handset cable (if fitted) and electrical supply cable cannot become
entangled with moving parts of the bed.
 DISCONNECT the electrical power cable from the mains and store before transporting the
bed.
 If the power cable shows any sign of damage, replace immediately.
 Some functions may cause injury to the patient if unintentional movement occurs. See
Nurse Control Panel instructions for handset lockout to avoid unintentional movement.
CAUTION
 Do not operate the bed controls for more than the control systems prescribed duty cycle
(i.e., no more than 6 minutes within a 60-minute period).
If in the event of a serious incident occurring in relation to the use of this medical
device, affecting user, or patient then the user or patient should report the serious
incident to the medical device manufacturer or the nominated distributor of the
product. In the European Union, the user should also report the serious incident to the
Competent Authority in the member state where they are located.

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2. INTRODUCTION
These instructions contain information for the installation, use and maintenance of the Prioma
Birthing Bed. The bed includes a range of functions and positional movements that assist
caregivers and provide for patient comfort. Ease of use, functionality, serviceability, and cleaning
practicality are key features of the Prioma Birthing Bed. The bed has a fabricated steel structure
with a powder coated finish. The plastic components are made from urethane, PP and POM nylon,
ABS and HDPE plastic.
2.1 Prioma Birthing Bed Key Features
 The Prioma bed has as adjustable height range (fitted with twin 150mm diameter
castors) of 48.5 cm low height to a maximum high height of 84.0 cm.
 Electrically actuated mattress platform Trendelenburg tilt (14°) and reverse Trendelenburg
tilt (12°), which includes an electronic horizontal timed stop function on electric models.
 Castors: Central locking with foot pedal operated braking and steering function. Central
locking castors are either 150mm, or 125mm diameter twin wheeled.
 Retracting backrest to help reduce abdominal squeezing.
 Integral mattress platform extension.
 Head end side rails: Light weight and durable HDPE (High-density polyethylene) blow
moulded side rails.
 Light weight, strong and durable interchangeable HDPE blow moulded head and foot
panels.
 If fitted: Under bed light.
NOTE: The battery back-up unit should be charged for 24 hours prior to first use. This
requires the bed to be plugged into mains power.
The model and serial numbers can be found on the specification label; this is located at the head
end of the bed below the moulded head panel.
CAUTION
 Before using the Prioma Birthing Bed, ensure that the “Power in” rating on the
specification label is compatible with the local electricity supply.

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2. INTRODUCTION - Continued
2.2 Product Overview
Note: Mattress - The single sided two part mattress is a standard accessory to the
Prioma Birthing Bed. It is not shown in the below overview for illustration purposes. For
further information see sections 4.2 Mattress, 4.3 Mattress and Side Rails and 8.6
Mattress Sections.
A. Leg Stirrup L. Backrest CPR Release Handle
B. Seat Panel M. Castors
C. Grab Handle N. Drainage Bag Rail
D. Upper Leg Support O. IV Pole / Self Help Pole Socket
E. Lower Leg Support P. Side Rail Release Handle
F. Base Extension Q. Nurse Control Panel
G. Under Tray R. Interchangeable Head/Foot Panels
H. Footrest Plate S. Drop Down Side Rail
I. Roller Buffer T. Backrest Panel
J. Brake/Steer Pedal U. Patient Control Panel
K. Accessory Sockets

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3. CLINICAL APPLICATION
3.1 Intended Area of Use
The Prioma Birthing Bed is appropriate for use in pre and post-natal ward and delivery rooms.
The use of the Prioma Birthing Bed is appropriate for all stages of childbirth, pre and post-delivery
and during delivery.
WARNING
To ensure the patient can use the bed safely, their age, size and condition should be
assessed by a clinically qualified person.
The Prioma Birthing Bed is a platform that transforms from bed to Obstetric
configuration by retraction of the foot end base extension. The bed configurations are
intended for patients that are not typically sick or ill and therefore are not at risk from
falls.
3.2 Application Environment
The bed is suitable for use in Application Environment 2 as defined in IEC 60601-2-52.
Application Environment 2
Acute care provided in a hospital or other medical facility where medical supervision and monitoring
is required, e.g., general medical and surgical wards.
3.3 Maximum Patient Weight
The safe working load (SWL) of the bed is calculated as follows:
(In accordance with IEC60601-2-52)
Maximum Patient Weight 135Kg
Mattress 14Kg
Accessories (including attached permanent side rails) 50Kg
TOTAL SAFE WORKING LOAD (SWL) 200Kg
WARNING
If the combined weight of the mattress and accessories exceeds 65kg, the maximum patient
weight must be reduced accordingly

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4. INSTALLATION
The following chapter describes how to install the bed.
WARNING
 If the power supply cord or plug is damaged, the complete assembly must be replaced by
authorised service personnel. Do not remove the fitted plug or use a rewireable plug or
adapter.
 Make sure the power supply cord is not stretched, kinked, or crushed.
 Do not allow the power supply cord to trail on the floor where it may cause a trip hazard.
 Make sure the power supply cord does not become entangled with moving parts of the
bed or trapped between the beds frame and moving parts.
 Disconnect the power cord from mains supply, and store as shown before moving the bed.
CAUTION
Before the first use, or if the bed has been unused for more than three months, connect the
bed to the electricity supply for at least 24 hours to allow the backup battery to recharge fully;
failure to do this may reduce the life of the battery. After charging, check that the battery is
fully serviceable by carrying out a battery test as shown in the Maintenance section of this
manual.
4.1 Electricity Supply
Connect the mains plug to a suitable socket outlet. Make sure the plug is easily accessible so it can
be disconnected quickly in an emergency.
The power supply cable should be wrapped
around the Cable Retainer (1) when the bed
is not in use or before moving the bed.
To isolate the bed from the electricity supply,
disconnect the power plug from the mains
socket outlet.
A potential equalisation terminal is located
behind the backrest fitted to the beds head
end rail tube. When other electrical
equipment is within reach of the patient or
caregiver, potential differences between the
equipment can be minimised by connecting
together their potential equalisation
terminals.

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4. INSTALLATION - Continued
4.2 Mattress
WARNING
Always use the mattress designed for use with the Prioma Birthing Bed. Incompatible
mattresses can create hazards.
4.3 Mattress and Side Rails.
It is important to consider the use of side rails based on clinical assessment of each individual
patient and in line with local policy. When assessing the suitability of the use of side rails, the
following factors should be considered.
 The bed is designed to provide an acceptable side rail height when used with a mattress of up
to 170mm thick.
 Mattress overlays are not recommended for use with this bed.
 To ensure compliance with IEC 60601-2-52, the specifically designed mattress designed for
use with the Prioma Birthing Bed is to be used.
5. ELECTRONIC CONTROLS
5.1 Control Handset - Optional
The Prioma Birthing Bed has the option of including a factory fitted control handset that is
connected to the beds control system by an extendable curly cord. The handset can be used
around the perimeter of the bed and can be hooked over the beds rails, or head and foot panels for
storage.
Adjustment occurs only while a button is pressed. Adjustment will stop when the button is released,
or the movement selection reaches the end of its range of adjustment.

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5. ELECTRONIC CONTROLS - continued
5.2 Nurse Side Control Panel
Single button press, to go for all functions. Lock out to hi-low, back rest and tilt positions.
Emergency assist functions include Trendelenburg and bed levelling (CPR). Angle gauge is a ball
bearing gravity movement type. Visual symbols include Power connected and battery indicator
lights. Example is of the left-hand side controller.
5.3 Patient Side Control Panel
Single button press, to go for all functions. Limited functions for patient safety are back rest and hi-
low positioning. Visual symbols for function locked out.
The Prioma Birthing Bed adjustments are powered by three electronic actuators which are either
controlled by handset, or by the inset buttons on both sides of the head end side rail panels.
NOTE: The following categories cover the range of electronic control devices and functions that are
available to the Prioma Birthing Bed.
NOTE: Adjustment occurs only while a button is pressed. Adjustment will stop when the button is
released, or the movement selection reaches the end of its range of adjustment.

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6. ELECTRONIC CONTROLS DESCRIBED
6.1 Backrest Adjustment
WARNING
Care should be taken whilst operating the backrest function to ensure hands and
fingers are away from potential squeeze hazards.
NOTE: This control function is available to all control devices fitted to the bed.
To move the backrest up or down, press and hold the appropriate button on the control
device. The backrest can be adjusted through a range of between 0° and 70°
The retracting backrest provides additional comfort for the patient by allowing the mattress
to expand. When operating the backrest buttons, the backrest slides progressively
towards the head end of the bed. This action enlarges the seat section of the bed and
helps prevent compression of the abdomen reducing shearing and risk of tissue damage.
The backrest adjustment actuator includes an inbuilt manual quick release CPR function
as well as a disengaging spline drive that only uses force in the push direction.
6.2 Mattress Platform Height Adjustment
WARNING
It is recommended that the bed be positioned at its lowest height when unattended by
caregivers to minimise the risk of patient injury from falls when getting in and out of the
bed.
To move the mattress platform up or down, press and hold the appropriate button on the
control device. The beds platform height can be adjusted through a range (fitted with
twin 150mm diameter castors) of 48.5 cm low height to a high height of 84.0 cm.
The mattress frame height adjustment uses two actuators working in conjunction and
separate to each other creating the vertical lift and enabling the bed to tilt in opposite
directions.
6.3 Tilt Positioning – Trendelenburg / Reverse Trendelenburg
CAUTION
Trendelenburg function should only be used under professional supervision.
To move the tilt positioning press and hold the appropriate button on the control device.
The tilt button allows the bed to be positioned in a foot or head down tilt position. Tilt
positioning achievable is between 0° and 14° for head down tilt and between 0° and 12°
for foot down tilt.
 In use the mattress platform may initially rise before tilting. The bed will automatically
adjust to ensure that there is adequate clearance between the mattress platform and
the mechanical structure of the bed before tilting.
 When reversing the tilt angle of the bed with the tilt button remaining depressed, the
mattress platform will pause at horizontal for two seconds before continuing with the
tilting movement.

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6. ELECTRONIC CONTROLS DESCRIBED - Continued
6.4 Cardiopulmonary Resuscitation (CPR)
Note: For the electronically activated emergency patient positioning function, it is NOT
necessary to press the ‘up/down’ buttons as the operation is programmed to operate
directly from the associated button.
CAUTION
When electronic emergency patient positioning functions are activated, care should
be taken over the potential of the beds moving parts to either trap or crush the
patient, caregivers and or other equipment.
Pressing the SINGLE BUTTON PRESS button, the bed will automatically level all
positioning functions back to a flat deck position whilst lowering the bed to a safe working
height.
6.5 Emergency Trendelenburg (head down tilt) Function
Note: For the electronically activated emergency patient positioning function, it is NOT
necessary to press the ‘up/down’ buttons as the operation is programmed to operate
directly from the associated button.
Pressing the “EMERGENCY TRENDELENBURG” button will lower the head and raise
the foot of the bed to the maximum tilt of 14°, while simultaneously lowering the back rest
and knee break back to a flat deck position – NO pause if passing through horizontal.
6.6 Lock Out Functions
This facility allows users to selectively disable some of the electrical features of the bed. In
normal operation the key functions of the bed should be in an (unlocked) state of use. This
is indicated on the ACC panel by LED lights above the function buttons.
To lock and unlock each function hold the “key” or “lock” button and at the same time
press the function button that is required to be locked or unlocked. An LED light will
illuminate when the function is in the locked position.
6.7 Battery Charge Indicator - Battery Backup
LED light illuminates when the battery is in charge mode.
The battery backup system allows the electrically operated functions to be used for short
periods when the bed is disconnected from mains power. The bed switches between
mains and battery power automatically.
The battery is lead-acid and should be charged regularly and not be allowed to discharge
fully. Fully discharging the battery will cause a reduction in battery life.
To charge the battery connect the power cord to the mains supply. This should be done as
often as possible to maximise battery life. If the bed is not used for a long period of time, it
is recommended that the batteries are charged in accordance with the section on
Transportation and Storage within this manual.

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6. ELECTRONIC CONTROLS DESCRIBED - Continued
WARNING
Do not expose the battery to open flame or immerse in liquid.
NOTE: The beds batteries should be charged for 24 hours prior to first use.
NOTE: Keep the bed plugged to mains power source for optimum performance.
NOTE: Bed adjustment will be slower when the power cord is unplugged, and the bed
is powered from its batteries only.
6.8 Mains Power Indicator
NOTE: Power cord storage is located at the head end of the bed. The cable should be
stowed when the bed is unplugged or in transport by wrapping around the “cord
minder” hooks.
6.9 Backrest Angle Indicator
The backrest angle indicator is a ball bearing gravity-based indication of the backrest
angle. When the back rest is in its flat position the angle indicator also provides an
approximate tilt degree indication also.
6.10 Under Bed Lighting - Option
NOTE: IF FITTED the LED under bed light will be permanently on when
connected to mains power.
The under-bed lighting feature provides a soft LED illumination of the floor beneath the
bed carriage. This safety feature provides floor illumination for patients at night when
getting in and out of bed. In the event the bed is operating on battery power (e.g., during
transport) the lights will power down after approximately 2-3 minutes of no button use.

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7. GENERAL BED OPERATION
7.1 Castor System
NOTE: The Prioma Birthing Bed has two castor options available (150mm twin or 125mm twin
wheeled). This section covers the locking and steering mechanism that is used.
Central Locking Castors – Brake & Steer
The central locking castor system is operated by use of foot pedals found at the head and foot end
of the bed. The pedal movement from horizontal is 30° both ways.
 With the pedals in the Red - Down Brake position the brakes are applied to all four castors of the
bed simultaneously and the bed is immobilised.
 With the pedals in the Horizontal Free position the brakes are released, and the bed can be
moved in any direction.
 With the pedals in the Green - Down Steer/Track position, a single steering castor at the head
end of the bed is engaged to provide better control when pushing the bed in a straight line.
 When moving the bed, push from the foot end holding the panels top push rail.
CAUTION
 Disconnect the bed power cord before moving the bed.
 Do not remove the power cord from the source by pulling on the cord.
 Do not use the beds side rails to manoeuvre the bed.
 Do not pull on the power cord, or handset cord to manoeuvre the bed.
 Always apply the brakes when the bed is in a stationary position.

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7. GENERAL BED OPERATION - Continued
7.2 Head & Foot Panels
The head and foot panels are easily removable from the bed allowing quick access to the patient.
There are no clamps or screws that are required to be adjusted before removal.
Installation & Removal
The panel includes a decorative infill to one side. There is no specific way in which the panels are to
be fitted as they are both interchangeable and therefore cannot be placed incorrectly. Generally, the
infill face of the panel is fitted to face towards the foot of the bed providing a more pleasing
aesthetic appearance.
To Install:
Using two hands align the panels bottom tubes with the beds corner sockets as shown in the below
diagram (A). Lower the panel gently until it seats at the bottom of the beds moulded corner sockets.
To Remove:
Reverse the above procedure.
CAUTION
Always install and remove the head and foot panels in line with the facilities Manual
Handling Procedures and Policies.

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7. GENERAL BED OPERATION - Continued
7.3 Bed Extension
To Retract: Apply the central locking brake system (refer page 13) raise the mattress platform to a
comfortable working height and remove the foot panel from the bed (refer page 14).
Next step is to remove the mattress leg section.
Grip both yellow coloured levers (A) at the foot end of the bed and lift upward (1) and begin pushing
towards the head end of the bed (2). The bed extension automatically locks in position when fully
retracted.
To Extend: Prepare the bed as described above.
Grip both yellow coloured levers (A) at the foot end of the bed, lift upward (1) and pull towards you
(2) to fully extend. The bed extension automatically locks in position when fully extended.
WARNING
To ensure maximum stability, do not sit or place loads greater than 90kg on the foot end of
the mattress platform in the area indicated by this label.

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7. GENERAL BED OPERATION - Continued
7.4 Manual Cardiopulmonary Resuscitation (CPR) Function
A clearly marked emergency CPR release handle is available on both sides of the bed. The manual
release function returns the beds backrest to a level position in the event of an emergency
resuscitation being required.
Emergency Lowering: To lower the backrest in an emergency, pull up on the red CPR release
handle. The handles are positioned at the side and towards the middle of the bed when the bed is
fully extended. The lowering movement is assisted by a gas damper, but CAUTION is required as
the backrest may lower quickly under patient weight.
WARNING
The backrest can fall quickly on release - keep hands clear to avoid trapping.

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7. GENERAL BED OPERATION - Continued
7.5 Drop Down Side Rails
The drop down side rails have two positions, either fully raised or fully lowered. When the side rail is
raised to its full height position it will automatically lock to its fully raised position. The lock position
is clearly audible.
WARNING
Do not operate side rails when there is potential of entrapment or crushing to the patient,
caregivers, visitors and/or other equipment.
WARNING
 Care should be taken whilst operating the side rails to ensure hands and fingers are kept
away from potential squeeze hazards.
 Side rails should only be used after clinical assessment and within organisational policy
and guidelines.
Side Rail Operation
To raise the side: Grip the top
of the rail (1) and lift until the
spring loaded lock mechanism
automatically clicks into its
locked position at maximum
height.
To lower the side: Hold the top
of the rail near the middle (1)
and gently pull forward the rail
release handle (2). As the rail
begins to lower the handle can
be released and the rail can be
gently lowered to its down
position. The rails are
mechanically dampened for
safety and ease of use.

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8. STANDARD ACCESSORIES
The Prioma Birthing Bed is supplied with a range of standard accessories.
For installation locations on the bed, refer to product overview page 5.
8.1 Under Tray
To use or for removal of the stainless steel tray (A), using two hands to give even leverage, pull
towards using the lip of the tray as the handle (B) and extend out until it comes to a stop position.
For complete removal of the tray, lift upwards and out from the underside steel support frame (C).
8.2 Grab Handle
Both Handles fit in the accessory sockets (A) at the foot of the bed.
Unscrew accessory socket locking handwheel (B) if necessary and fully insert Handles (C) inside
the socket. Lock in position via handwheel (B).