Arjo Prioma User manual

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

Page | 1
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

Page | 2
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.

Page | 3
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.

Page | 4
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.

Page | 5
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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

Page | 6
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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

Page | 7
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.

Page | 8
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.

Page | 9
Commercial in confidence. Instructions for Use Manual Revision PBB-IFU-REV13-020622
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.