13. DISPOSAL OF PARTS & ENVIRONMENTAL CONSIDERATIONS 44
14. ELECTROMAGNETIC COMPATIBILITY (EMC) 45
15. SPECIFICATION 46
15.1 Bed Specification 46
15.2 Performance Characteristics 47
16. ACCESSORIES 48
16.1 Mattress / Side Rail Compatibility Chart 49
17. WARRANTY 50
18. NOTES 51
5
1. INTRODUCTION
Thank you for purchasing a Drive DeVilbiss Healthcare Innov8 Low general ward
bed. For safety reasons it is imperative that these instructions are read and fully
understood before the bed is used for the first time. For assistance in setting up, using
or maintaining your bed or to report unexpected operation refer to the contact details
found in section 2.
2. CONTACT INFORMATION
For any service, warranty, sales or customer service information on this product
please contact your provider or if in doubt contact Drive DeVilbiss Healthcare Ltd.
at the following address:
Drive DeVilbiss Healthcare Ltd.
Heathfield Lane
Birkenshaw
West Yorkshire
BD11 2HW
UK
Please quote the product serial number on all correspondence.
For Service & Support outside the UK & Northern Ireland please contact the local
distribution company from where this equipment was purchased. Failure to do so
may result in the product warranty becoming void.
6
3. PRODUCT DESCRIPTION
3.1 Environment
The Innov8 Low bed is intended for use in a hospital where acute/intensive care is
provided and medical supervision and monitoring is required.
3.2 Intended Patient Group
The bed frame is intended for an adult who is up to 190kg in weight. A lower (or
upper) age limit is not defined as it depends on the physical size of the patient in
relation to the various proportions and gaps around the bed frame. Patients must be
in excess of 146cm in height ranging up to 205cm (bed extended) and have a BMI
greater than 17.
3.3 Intended Use
The intended use of the bed is for sleeping / resting and it is intended to assist in
diagnosis, monitoring, prevention, treatment, alleviation of disease or compensation
for an injury or handicap, as determined by the end user and care staff.
The bed frame is intended to support a single adult. A risk assessment must always
be performed on the suitability of the patient to the bed frame and any ancillary
accessories.
The patient is only defined as such when situated in the bed. Both the professional user
and patient are intended to operate the bed. It is the professional user’s responsibility
to determine that the patient is both mentally and physically capable of operating the
bed functions with minimal risk of personal injury.
The bed is intended to provide patients with optimum independence and freedom of
movement and carers with greatly reduced manual handling needs via the electrically
operated movable sections.
For assistance in setting up, using or maintaining your bed or to report unexpected
operation refer to the contact details found in section 2.
7
3.4 Product Overview
The Innov8 Low bed is intended to be plugged into a permanent mains supply however
it also has a battery backup system for such times that a mains supply is not available.
The bed has two separate handsets, one for the carer with full control capability and
one for the patient with limited functionality and limited height adjustment. The carer
has the ability to lock out individual functions to reduce the risk of accidental operation.
The handsets operate an electronic linear actuator system which is controlled via a
central control box. The actuators are attached to the moving parts of the bed frame
allowing the bed to be operated via the use of either handset.
The powder coated platform supports the full electrical system, five removable plastic
platform panels, two plastic bed end boards and a set of side rails to provide patient
protection; the bed has a safe working load of 255kg. The bed is manoeuvrable via
the aid of four linked castors attached to the base frame of the bed which in turn is
attached to the platform frame via two lift arms.
3.5 Features
• Electrically operated height, backrest and leg section adjustment.
• Auto regressing backrest.
• Electrically operated head and foot down tilt (Trendelenburg & reverse
Trendelenburg).
• Auto-contour – simultaneous adjustment of the backrest and knee-break.
• Cardiac chair position.
• Battery backup.
• Patient handset and carer handset with integral function lockout.
• Removable head and foot ends.
• Removable mattress platform panels.
• Mattress platform extension.
• Castor system with brake, free and tracking modes.
8
4. SAFETY
4.1 Warnings & Cautions
Warnings in this user manual highlight potential hazards that if
disregarded could lead to injury or death.
Warning
Cautions in this user manual highlight potential hazards that if
disregarded could lead to equipment damage or failure.
Caution
4.2 Risk Assessment
Before a patient uses the bed a risk assessment must be performed on a patient by
patient basis. The risk assessment should include, but is not limited to:
• Entrapment.
• Falling out of the bed.
• Small adults (and children).
• Patients with learning difficulties.
• Very active patients.
• Unauthorised people.
• Use of side rails.
• Items/equipment/cables under the bed.
Warning
Bed functions must be locked out if there is any doubt about the ability
of the patient to operate the bed safely.
9
4.3 Contraindications
Patient conditions for which the use of the bed is a contraindication are as follows:
• Cervical or skeletal traction – If bed functions remain unlocked.
• Unstable spinal fractures – If bed functions remain unlocked.
• General skeletal fractures – If relevant bed functions remain unlocked.
• Mental capacity not sufficient to operate handset functions safely – If bed functions
remain unlocked.
• Confused, agitated or restless – If side rails fitted and/or in raised position.
• Exceeds maximum patient weight of bed.
• Less than 146cm in length.
Other contraindications may be relevant which are specific to the patient or care
environment.
4.4 Bed Loading
• The safe working load of the bed is: 255kg (40 stone)
• The maximum patient weight of the bed is: 190kg (30 stone)
Safe Working Load is the sum of:
• Patient mass
• Mattress mass
• Accessories mass
• Mass supported by the accessories (excluding patient mass)
Warning
The maximum loads shown above are for the bed to be occupied by one
person only. The bed is not designed to take the weight of visitors sitting
on the side of the bed. Additional weight could damage components or
cause the bed to overturn, causing injury.
10
4.5 Training
All users of this bed are to be suitably trained prior to use and patients are to be
familiarised with handset and bed functionality at the earliest opportunity. It is the
responsibility of the end user to ensure they have received sufficient training to use the
bed and any associated accessories safely and correctly.
For further information in regards to training options please contact Drive DeVilbiss
Healthcare Ltd. or your local provider (see section 2).
4.6 General Warnings
• The bed is to be installed and put into service in accordance with
the information provided in these instructions for use.
• The bed is typically not suitable for child use, if it is to be used
for child occupancy ensure a risk assessment has been undertaken
taking into account the proportions of the child and dimensions of
the bed frame.
• The bed is designed for occupants who are 146cm or longer in
length; if a person shorter than this length is put on the bed a full
and detailed patient specific risk assessment must be carried out,
taking the proportions of the bed frame and side rails into particular
consideration.
• Misused electrical equipment can be hazardous.
• Accessories that have not been approved or designed for use with
the bed are not be used.
Warning
• Modification of the bed frame is not allowed without the permission
of Drive DeVilbiss Healthcare Ltd.
• The bed is not to be used in the presence of flammable gasses or
used in oxygen rich environments.
• The bed is not to be used in an operating theatre.
• If children or adults with learning difficulties pose a potential risk
of intentional or unintentional tampering with the bed its suitability
for use is to be considered during the initial patient / product risk
assessment.
• The RF emissions from the electrical system are very low and are
not likely to cause any interference to nearby electronic equipment,
however interference to sensitive equipment is possible (see
section 14 for further detail).
11
5. TRANSPORT & STORAGE
The following conditions should be followed when transporting and storing the Innov8
Low bed. Note, this does not apply to the transfer of the bed between wards and / or
when the bed is in use (see section 9.4).
• Bed set to lowest height.
• Bed always to be stored on a flat and level floor.
• Platform extension retracted.
• Brakes applied.
• All profiling sections secured (transport only).
• All functions locked out.
• Covered to protect from fluid ingress, dirt, dust etc.
• Instructions for use retained with bed.
• Environmental conditions for transport and storage:
Ambient temperature: -10°C to +50°C
Humidity: 20% - 90% at 30°C - not condensing
• To prevent the risk of cross infection, when removing a bed from
use ensure that all activities in relation to the bed and its ancillary
parts are carried out using disposable gloves and that they are then
discarded appropriately, unless it can be verified that the bed and
the ancillary parts have been suitably cleaned and disinfected prior
Warning
to collection.
• Prior to putting into storage ensure the bed has been cleaned and
disinfected in line with the local infection control policy and / or as
defined in section 11 of these instructions for use.
Caution
• Beds must not be stored one on top of another or on their side.
• Care is to be taken when pushing the bed over thresholds.
• Do not use the side rails to move the bed – Risk of product damage.
12
6. SYMBOL DEFINITION
The following symbols are found on this bed:
(See section 9.12 for handset symbols)
Symbol
Description
Warning
Beware of potential hazard
Caution
Beware of potential product damage
Refer to instructions for use - Recommended
Failure to read the instructions for use could introduce a hazard
Refer to instructions for use - Mandatory
Failure to read the instructions for use could introduce a hazard
Maximum patient weight
Refer to section 4.4
Safe working load
Refer to section 4.4
Mattress suitability
Refer to section 16
Dynamic mattress strapping suitability
Refer to section 16
Low height warning
13
Symbol
40 kg
BMI 17
146 cm
Description
Equipotential stud
Minimum patient weight
Minimum patient BMI
Minimum patient height
Type B applied part
Lot number
REF
Product code
Date of manufacture
Manufacturer
W.E.E.E Label - Found on individual parts of electrical system
(Waste Electrical and Electronic Equipment) Refer to section 13
14
7. PARTS IDENTIFICATION
Accessory
mounting points
Patient
handset
Manual CPR
handle
Removable
mattress panels
Bed extension
release plunger
Mattress
retainers
Safety side
rails
Removable head
and foot ends
Carer handset
Brake bar
15
8. INSTALLATION & PREPARING FOR USE
Prior to operating the bed for the first time the following simple steps must be
performed:
• Ensure the wooden packing boards are removed from the bed prior to connecting
to the mains supply – See section 13 for disposal of the packing boards.
• Ensure the bed and all accessories are at room temperature.
• Ensure the bed has been cleaned and disinfected (see section 11).
• Ensure the brakes have been applied (see section 9.3).
• Connect the mains cable to an appropriate mains socket outlet.
• With the bed plugged into the mains supply allow it to remain inactive for 6hrs.
This is to allow the bed frame and electronic system to adjust to the environmental
conditions of the room.
• The bed is to be left in its lowest position when the patient is
unattended in order to reduce the risk of injury due to a fall.
• Before operating the bed ensure the patient is positioned
appropriately ensuring all limbs are clear of moving parts.
• The mains plug is the disconnect device for the means of isolating
the bed from the mains supply, the plug must be accessible at all
times.
• Ensure the mains cable is plugged into an appropriate power
source at all times.
• To avoid the risk of an electric shock, this equipment must only be
connected to a supply mains with protective earth.
• Ensure the electrical cables are not in tension, paying particular
attention to the mains cable.
Warning
• Ensure that all cables are clear of all moving parts to prevent
damage to the electrical components.
• Inappropriate handling/positioning of the mains cable could cause
kinking or shearing of the cable which may lead to exposed live
wires, creating an increased risk of electrocution.
• Precautions are to be taken when routing cables from external
equipment around the bed to ensure that they do not become
squeezed, trapped or damaged.
• A CE marked extension cable must only be used when it is not
possible to reach a wall socket with the mains cable – Contact
Drive DeVilbiss Healthcare Ltd. for detail with regards to the safe
use of extension cables.
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