Novis Premium9 User manual

user guide
9 digital

Important Notice
Before operating this medical equipment, it is
important to read this User Guide and understand
the operating instructions and safety precautions.
Failure to do so could result in patient injury and/or
damage to the product.

page
Safety Precautions 4-6
Product Overview 7
Installation & Operation 8-15
Troubleshooting 16 - 17
Cleaning 18-19
Maintenance 20
Technical Specifications 21-26
Warranty Information 27

4
safety precautions
The purpose of the following safety precautions are to
direct your attention to possible dangers. The safety
symbols and their explanations, require your careful
attention and understanding.
The safety warnings by themselves do not eliminate any
danger. The instructions or warnings they give are not
substitutes for proper accident prevention measures.
The following symbols may appear in this User Guide,
on the Control Unit, or on its accessories. Some of
the symbols represent standards and compliances
associated with its use.
SAFETY ALERT SYMBOL: Indicates caution or
warning.
WARNING: Failure to obey a safety warning can
result in serious injury to yourself or to others.
Always follow the safety precautions to reduce
the risk of fire, electric shock and personal injury.
DOUBLE INSULATION
Double insulation is a safety concept of electrical
equipment which eliminates the need for earth
grounding. Whenever there is electric current
in the Control Unit there are two complete sets
of insulation to protect the user. All exposed
metal parts are isolated from the internal metal
components with protecting insulation.
WARNING: The double insulated system is
intended to protect the user from shock resulting
from a break in the Control Unit’s internal wiring.
Observe all normal safety precautions related to
avoiding electrical shock.
WARNING: Servicing a Control Unit with double
insulation requires extreme care and knowledge
of the system and should only be performed by
a qualified service technician. For service we
recommend you return the Control Unit to your
nearest Novis Healthcare Authorised Service
Centre for repair. When servicing, use only
identical replacement parts.
OPERATING INSTRUCTIONS
WARNING: Do not attempt to operate this
product until you have thoroughly read and
completely understand the safety precautions
contained in this User Guide. Failure to comply
can result in accidents involving fire, electric
shock or serious personal injury. Save the User
Guide and review frequently for continual safe
operation and for instructing others who may use
this product.
Maximum recommended patient weight for this
system is 180 kg.
Only use the combination of Control Unit and
Mattress as specified by Novis Healthcare,
otherwise the correct function of this product
cannot be guaranteed.

5
safety precautions
WARNING: This device is not suitable for use
in the presence of a flammable anaesthetic
mixture with air, or in the presence of a
flammable anaesthetic mixture with oxygen
or nitrous oxide.
WARNING: Bed frames used with the
systems can vary greatly depending on the
specific health care setting (ie hospitals,
nursing homes, home care, etc). It is the
responsibility of the caregiver to take the
necessary precautions to ensure the safety
of the patient. This includes, but is not
limited to, the appropriate use of side rails to
prevent falls and/or patient entrapment.
IMPORTANT: Minimise articles between
the system surface and patient, and secure
bed sheets loosely so as not to affect the
alternating cell movement.
WARNING: Significant risks of reciprocal
interference may be posed by the Control
Unit during specific investigations or
treatments. Potential electromagnetic or
other interference between the Control Unit
and other devices may occur. If interference
is suspected, move equipment from sensitive
devices or contact Novis Healthcare.
Only plug into a grounded power outlet
using the power cord supplied with the
system.
Exposure of the electronic Control Unit to
any liquid while it is plugged in could result
in a severe electrical hazard.
Preventive inspection and calibration is not
required.
Do not modify this equipment without
authorisation of the manufacturer.
The Mattress is treated as the applied part of
a medical electrical (ME) system.
Do not position the system so that it is
difficult to disconnect.
Keep the equipment away from children and
animals.
Long power cord and air hose. To avoid
strangulation and entanglement, keep cable
and hoses out of reach of young children and
animals.
Novis Healthcare recommends running the
cord through the cord retention loops on
the mattress and attaching it to an electrical
outlet by the head of the bed.
The power cord to the Control Unit should be
positioned to avoid a tripping hazard and/or
damage to the cord.
control unitin general

6
Unplug the Control Unit from the mains power
supply to disconnect the power when not in use.
The Control Unit is tested and approved
according to ISO-EN 60601-1 Rev.3 & EMC
Repairs and service should be conducted by
the manufacturer or authorised personnel. If
the Control Unit is not functioning properly, or
has been damaged, unplug the unit and take
it out of service immediately. (See contact
information on cover for repair and service
information).
Do not place any objects or items, such as
blankets, on or over the Control Unit.
The electronic Control Unit is a precision
product. Use care when handling or
transporting. Dropping or other sudden impacts
may result in damage to the unit. Before
attaching the Control Unit to the foot board
of the bed, ensure the mounting surface is
sufficiently robust and free of damage.
WARNING: Risk of electrical shock: do not
open and/or attempt to repair or service the
Control Unit. If parts need to be repaired, circuit
diagrams and parts lists can be provided by
Novis Healthcare to suitably qualified service
personnel.
WARNING: Only use fuses that have the same
specified rating (see Technical Specifications).
Using fuses with higher ratings could result in
damage and/or injury.
NOTE: No special skills, training or knowledge are
required to operate the Control Unit.
safety precautions

7
The 9 Digital is an Alternating Mattress System
providing pressure application and relief for patients
with, or vulnerable to pressure injuries. It is designed
to be used on either standard or profiling single bed
frames.
The 9 Digital Alternating Mattress System consists of
the following:
• Control Unit
• Mattress
• Power Cord
• User Guide
• Carry Bag
The Control Unit provides the air supply to the
Mattress. It is controlled by a digital touch membrane
on the front panel which controls eight comfort
settings, Alternating or Static Mode for treatment
or transfers respectively, and Max Inflate function
to facilitate quick Mattress inflation. The Alarm LED
indicator and Alarm Mute completes the profile.
The visible and audible alarm function has a number of
indications depending on the cause of the failure.
On the side of the Control Unit are four male air
connectors for quick connection of air hoses. The
connectors include a locking lever on the handle for
safety and ease of use.
The mains supply to the Control Unit can be easily
disconnected and is designed to detach if pulled too
firmly – protecting the internal wiring of the unit.
The mattress comprises 19 air cells including 3
static head cells to provide static ‘pillow’ support
for optimum comfort. Air pressure in the other 16
cells including the heel zone is alternated over a
12 minute cycle. This provides regular periods of
pressure reduction to aid blood and lymphatic flow to
vulnerable tissues.
The system includes a rapid release CPR tag for
emergency deflation.
product overview

8
unpacking & inspection
NOTE: It is recommended that all packing materials
and instructions be kept in the carry bag provided,
in the event the product has to be shipped to an
approved Novis Healthcare Service Centre.
Carefully remove the Control Unit, Mattress and
accessories from the shipping cartons. Inspect all
items for any damage that may have occurred during
shipping. Any damage or missing components
should be reported to a Novis Healthcare Service
Centre as soon as possible.
The box should contain the following items:
• Completely assembled 9 Digital Mattress System
• Carry Bag
• Digital Control Unit
• Medical Grade Power Cord
• User Guide
The Mattress is treated as an applied part of this
Medical Electrical (ME) system.
installation & operation

9
installation & operation
A. power button
Turns system power on and off by pressing the power
button for at least three seconds.
B. alarm LED
This red light flashes, and an audible alarm sounds, to
alert when Control Unit or Mattress pressure fails. The
alarm has five different signals to indicate the cause of
the failure.
The audible alarm also sounds when power is
disconnected – press Alarm Mute to silence. Refer to
Alarm Function [page 14] and Troubleshooting [page
16-17], or Alarm Indication Guide on the right side of
Control Unit for cause of alarm and resolution
C. alarm mute button
Silences the audible alarm. Audible alarm will resume
after 20 minutes if cause of error is not resolved.
D. mode button
Once initialisation is complete, press to toggle
between Alternation Mode (alternative cells cyclically
inflating and deflating) and Static Mode (all cells fully
inflated with no dynamic alternation). Static mode
will automatically revert to Alternation Mode after 20
minutes for patient safety.
E. comfort setting buttons
Press arrows to increase or decrease pressure setting.
Eight pressure settings from soft to hard are available
(18mmHg to 60mmHg; 6mmHg per step). The green
LEDs illuminate to indicate which of the eight settings is
selected. Press the right arrow to increase firmness, left
arrow to decrease firmness.
F. max inflate button
Press to facilitate rapid inflation to maximum pressure
setting (60mmHg). After 20 minutes, the system
automatically reverts back to the previous pressure
setting for patient safety.
G. control unit lock/unlock button
To prevent tampering and unintended operation,
press for at least three seconds to lock the Control
Unit settings – a beep sounds and the amber LED
illuminates to indicate system is locked. When locked,
only the Alarm Mute and Lock/Unlock buttons remain
operational.
Press again for at least three seconds to unlock (beep sounds
and amber LED turns off).
The Control Unit will automatically unlock in the
event of a power failure.
control unit panel D AE FB CG

10
installation & operation
The following describes the procedures to follow when
setting up the system for the first time.
a) Remove all blankets, bedding, sheets and mattress
from the existing bed.
b) Position Mattress Replacement, with its top cover,
on top of bed frame and position hose ends at foot
of bed for Control Unit. The feet symbol on the
Mattress Replacement indicates location of the foot
end.
c) In a profiling bed, secure the side straps around the
moveable sections of the bed base. DO NOT SECURE
TO THE SIDE RAILS – THE STRAPS WILL TEAR OFF!
d) Unzip top cover and check CPR sealing plugs are
pushed fully onto the connectors.
[for details see page 13]
e) Confirm there are no sharp objects in the immediate
area which may cause damage to the Mattress
Replacement.
IMPORTANT: Make sure that the attachment of the
Mattress Replacement does not interfere with the
movement or operation of the bed.
The system is designed to operate in a controlled
environment free from extreme temperatures, high
humidity and/or excessive amounts of airborne particles,
such as dust and smoke.
setting up mattress replacement
a) Position Control Unit by its hanging hooks over foot
board of the bed or on the floor under the bed.
b) i. Depress the lever on the top of the handle.
ii. Aligning the connectors on the handle with those
on the Control Unit, firmly push the handle into
position.
iii. Release the lever, ensuring this has engaged onto
the catch connected to the Control Unit.
iv. Ensure air hoses do not kink between bed frame
and Control Unit.
c) Position the power cord through the cord retention
loops along the side of the Mattress base and insert
power cord into Control Unit, then into a grounded
240 V AC 50 Hz electrical outlet.
1
23
setting up control unit

11
installation & operation
d) Press the power button for more than three seconds
to activate Control Unit. The pressure LEDs will flash in
sequence indicating that the system has activated.
Allow up to 40 minutes for initialisation, alarm will
sound if mattress fails to reach operating pressure
after 50 minutes.
e) Once ready, the fourth pressure LED as well as
the alternating LED will illuminate to indicate that
the system is ready for use (system automatically
defaults to alternation mode after initialisation).
f) Once the Mattress Replacement is fully inflated,
bedding can be placed. Secure sheets loosely
enough to ensure they do not interfere with cell
alternation. Do not use thick mattress covers or
blankets which will interfere with cell alternation.
g) Transfer the patient to the Mattress Replacement
and perform a ‘Bottoming Out’ test to ensure that
the patient is properly suspended. Refer to page 12
for more details.

12
installation & operation
Establishing Pressure (supine patient)
With the patient lying supine (on his/her back, face
upwards), use the comfort arrows to cycle through the
eight available pressure settings.
Based on patient weight and comfort requirements,
establish the best setting for effective alternation,
support and comfort.
Before changing or lowering the pressure, ensure
the system is working effectively by performing a
‘Bottoming Out’ test:
a. Ensure system is in alternation mode but is not
undergoing an alternation (cells inflating or
deflating).
b. With the patient lying supine, unzip one side of the
top cover just past sacral region (lower spine).
c. Slide your hand underneath the patient and feel for
a deflated cell under the patient’s lower spine. The
inner static cell will remain inflated, however your
hand should easily slide between patient and base.
d. If a hand can pass under patient then the patient
is adequately suspended and pressure can be
lowered if desired.
e. Repeat Bottoming Out test at least 12 minutes
after pressure has been adjusted.
After approximately 20 minutes, reassess system
function and patient comfort. In the event of a system
error, the alarm will activate and pressure LEDs will
flash indicating a fault.
For quick reference, a comfort setting guide can
be found on the right side of the Control Unit, with
indicative settings according to the approximate
weight of the patient.
Establishing Pressure (inclined patient)
When moving the patient to a sitting or more upright
position, pressure may need to be increased (by
approximately 20% or up to two levels on the comfort
setting) to provide added support and to avoid
‘Bottoming Out’.
IMPORTANT: It is important to return to the original
pressure setting when the patient returns to the supine
position.
IMPORTANT: Wait a minimum of 12 minutes between
pressure adjustment and patient assessment, as it may
take a full cycle for the system to adjust.
CPR function
Rapid deflation of the Mattress Replacement may be
required for emergency treatment or to decommission
the unit. The CPR tag located at mattress head should
be used in the event that patient CPR or emergency
treatment is required.
1.Firmly pull the CPR tag outwards and upwards to
rapidly deflate the entire system, ensuring all four
sealing plugs are fully detached from the connectors.
mattress function

13
2. Remove patient prior to re-inflation. Power off
Control Unit. To re-inflate the system after the CPR
tag has been pulled, unzip the top cover to reveal
the CPR connectors, undo the air cell press studs
above the CPR connectors to gain access. Align the
CPR seals with the corresponding connectors.
3. Press firmly to ensure an airtight seal.
IMPORTANT: Do not position the system to make it
difficult to operate the CPR Tag. Perform a Bottoming
Out test after re-inflating the mattress following rapid
deflation (see page 12).
4. Ensure the CPR tag is correctly fed through
the opening in the left side bolster and through
the zippered opening in the mattress base when
reattaching. Zip up the opening when done.
5. Power on Control Unit. Wait for initialisation to
complete before placing patient back on Mattress
Replacement.
installation & operation

14
Initialisation Mattress has failed to reach minimum
Failure operational pressure within 50 minutes
Low Pressure Pressure has fallen 5mmHg or more
below the setting minimum
High Pressure Pressure has exceeded the setting
maximum by 10mmHg or more
Alternating Mattress has failed to commence alternation
Mode failure
AC power failure No pressure output due to mains power failure
alarm function
The red Alarm LED flashes, and an audible alert
sounds, to indicate the Control Unit or Mattress is
experiencing a fault. The LED will remain illuminated
until the fault is cleared. The audible alarm
can be silenced for 20 minutes by pressing the
Alarm Mute button.
The system has five different alarm signals, identified
by five different Pressure Setting illumination
sequences. The signals and corresponding Pressure
Setting LED displays are illustrated below.
If alarm activates and the system fails to inflate or
loses pressure, refer to Troubleshooting on
page 16-17.
display alarm/fault
installation & operation

15
transport function
1. Before patient transport, press the Max Inflate
button and wait at least five minutes for all cells to
inflate to maximum pressure.
2. Once Mattress pressure has reached maximum
inflation, press the Power button for at least three
seconds to switch off the Control Unit. Switch off
the mains supply and unplug the
power cord.
3. Remove the ‘D’ handle from the
Control Unit and seal with the attached handle
cap. The length of time the air
is retained in the Mattress will depend on the
weight and height of the individual patient.
If the patient is responsive, check
comfort level based on current pressure and adjust
accordingly.
IMPORTANT: Always perform a ‘bottoming out’ test
(see page 12) to ensure the patient is adequately
supported and not touching bed base.
mattress deflation and storage
1. Press the power button for at least three seconds
to switch off the Control Unit. Switch off the mains
supply and unplug the power cord.
WARNING: Unplug the Control Unit from the
mains power supply to disconnect the power.
2. Pull the handle to disconnect air hoses from the
Control Unit. This will deflate all cells except the
three static head cells.
3. To deflate the head cells, firmly pull the CPR tag to
disconnect the sealing plugs from the connectors.
4. Place Control Unit and power cord on top of the
Mattress and detach Mattress from bed.
5. Once fully deflated, roll up the Mattress and return
all items to Carry Bag for safe keeping.
IMPORTANT: Prior to re-starting the system, ensure
the CPR tag is reattached and connectors are fully
resealed.
installation & operationC

16
troubleshooting
alarm/fault display solution
Control Unit does not
operate; no display lights
illuminate
The Control Unit may
not be attached to a
power source or a fuse
may need replacing
1. Check the Control Unit is connected to mains
power outlet with the correct voltage.
2. Check the Control Unit is switched on. Switch off
and unplug the unit before restarting.
3. Check the Control Unit fuse (1 AMP) – fuse can be
released using a screwdriver to push and turn.
(see page 20)
WARNING: Do not try to open the Control
Unit. Opening the unit could cause personal injury or
equipment damage.
Alarm LED Initial failure 1. Reset the alarm – turn off Power and press the
Alarm Mute button.
2. Check all air hoses along the inside of the Mattress
– each should be firmly connected. Check each air
cell is securely attached to its connecting air pipe.
3. Check all cells, pipes and hoses for any air leakage.
4. Switch on Power.
+ audible alarm
Alarm LED Pressure too low 1. Reset the alarm – turn off Power and press the
Alarm Mute button.
2. Check the CPR tag is intact, ensuring the sealing
plugs are firmly fitted to the connectors.
3. Check all air hoses along the inside of the Mattress
– each should be firmly connected. Check each air
cell is securely attached to its connecting air hose.
4. Check all cells, pipes and hoses for any air leakage.
5. Check that the air filter cover is correctly secured
and the air filter is clean.
6. Switch on Power.
+ audible alarm

17
troubleshooting
Alarm LED AC power failure 1. Press the Alarm Mute button to silence the audible
alarm.
2. Check the power cord is firmly plugged into the
mains outlet and the Control Unit; and check the
mains power is switched on.
3. Check the Control Unit fuse (1 AMP) – fuse can be
released using a screwdriver to push and turn.
+ audible alarm
Patient is sinking or
‘bottoming out’
whilst lying flat
on the Mattress
The pressure maybe
set too low for the
patient’s weight
1. Increase the pressure setting by pressing up the
Pressure arrow.
2. To check effective system performance, conduct a
‘bottoming out’ test as described on page 12.
NOTE: If the problem is not resolved, please contact
an authorised Novis Healthcare Service Centre.
alarm/fault display solution
Alarm LED Pressure too high 1. Reset the alarm – turn off Power and press the
Alarm Mute button.
2. Detach the handle from Control Unit to reduce
pressure – reconnect when pressure
has decreased.
3. Check for twists in the air hoses between Mattress
and Control Unit.
4. Switch on Power.
+ audible alarm
Alarm LED Alternating
Mode Failure
(no alternation)
1. Reset the alarm – turn off Power and press the
Alarm Mute button.
2. Disconnect the air hoses to reduce pressure –
reconnect when pressure
has decreased.
+ audible alarm

18
cleaning
Infection Control and routine cleaning must be carried
out in accordance with your local Infection Control
Policy.
It is suggested that all disinfection be done with a high
grade disinfectant in accordance with manufacturer’s
instructions.
NOTE: The top cover seams are sealed to help prevent
moisture ingress and bacterial growth in the seam
stitching.
WARNING: Do not use high temperature
autoclave, or use phenolic based products for cleaning.
IMPORTANT: It is recommended the system is cleaned
between patients and every two weeks if in constant
use.
mattress base
Swab the mattress base and cells with a solution of
Sodium Hypochlorite or similar (up to 10,000ppm
available chlorine). Dry thoroughly before refastening.
CAUTION: Do not machine wash or dry the air cells or
Mattress base.
IMPORTANT: Do not disassemble the Mattress unless
cleaning is required. If cleaning or disinfecting is
required, do not disconnect the hoses from the air cells.
Never or allow fluid and moisture to enter air cells and
air hoses.
NOTE: Refer to the top cover wash tag for cleaning
instructions.
If there are visible signs of body fluids or other
substances, the top cover should be washed. The top
cover can be machine washed (up to 70°C) using
disinfectant according to manufacturer’s instructions.
Some surface wrinkling may result from cleaning
procedures. This has no adverse effect on the fabric’s
properties.
In washing machines, it may be difficult to wet out full
covers. Correspondingly, spinning and tumbling may not
remove water trapped between layers. It may be helpful
to interrupt the washing or drying cycles to alleviate
this.
Corrosive or abrasive cleaning agents must not be used.
CAUTION: Do not dry the top cover using the heat cycle
or a dryer. Air dry or select a non heat dry cycle.
If there are no visible signs of body fluids or other
substances, the top cover should be sanitised.
top cover: machine laundering

19
cleaning
light soilage
Superficial dirt on the coating may be removed
by wiping with a soft cloth moistened with water
containing a neutral detergent. More persistent
contamination may be treated by wiping with alcohols
or turpentine substitute, followed by hot water and
detergent.
Routine cleaning and disinfection in situ may be
carried out on the cover with warm water and a
neutral detergent or with a sodium hypochlorite
solution (0.1% or 1,000 parts per million available
chlorine).
Decontamination: For the decontamination of blood
spills or heavy soilage
The material is compatible with 10,000 ppm available
chlorine in solution. After the 2 minute required dwell,
excess solution must be removed and the surface
thoroughly rinsed and dried prior to reuse or storage.
Proprietary disinfectants may be used provided
manufacturer’s instructions are followed.
All cleaning agents, and disinfectants, must be
thoroughly rinsed off and the item dried before
storage. Failure to do this may result in the
accumulation of reagent that could damage the
polyurethane coating, react with the bed frame, or
negate the biocompatibility properties of the fabric.
storage
Store in a cool, dry area. Avoid excessive pressure and
contact with non-colourfast materials.
control unit
WARNING: Ensure the Control Unit is
disconnected from the mains electricity supply before
cleaning.
WARNING: Do not spray disinfectant directly on
to the Control Unit, or immerse the Control Unit in any
type of fluid. This could pose a severe electrical hazard
as this equipment has no protection against ingress
of water.
Wipe down Control Unit with warm water containing
detergent (or with a solution up to 10,000 ppm of
Sodium Hypochlorite or similar) and dry thoroughly
before use.
top cover: wiping by hand and disinfection

20
air filter
1. Switch off the power supply to the Control Unit.
2. Disconnect the power cord and
air hoses.
3. Place the Control Unit on a flat surface with back
panel uppermost (place soft cloth under unit to
prevent scratches).
4. Carefully remove air filter cover, remove and
discard the filter material and fit new filter (there
may be a small locking screw – use a small small
flat head screwdriver to remove}.
5. Refit the air filter cover to the Control Unit. The
Control Unit is now ready for re-connection.
NOTE: Good filter maintenance is critical
to maintain your system in optimal operating
condition. Failure to keep the filters clean will result in
system downtime and increase repair costs.
It is recommended that the air filter be replaced
annually. Air filters are available from a Novis
Healthcare Service Centre. Preventative inspection and
calibration is not required.
fuse
1. Switch off the power supply to the Control Unit.
2. Remove the power cord from the electrical socket
on the side of the base of the Control Unit.
3. Insert a small flat head screwdriver into the groove
and turn anti-clockwise (quarter turn).
4. Remove the “blown” fuse from the fuse holder clip
and discard.
5. Insert a new fuse into the plug.
Push against the force of the spring and turn
clockwise with the screwdriver (quarter turn).
maintenance