Squirrel Medical Dormir 8535 MRS User manual

Squirrel Dormir 8535 MRS
Dormir 8535 MRS / Dormir 8535 Plus MRS
Instructions for Use
IMPORTANT! Read the instructions in this booklet thoroughly prior to use.
Keep these instructions for future reference.

Page 2 of 41 Copyright Squirrel Medical® 2017 - E&OE
Contents
1. Introduction _______________________________________________________________________________________3
1.1 Foreword ________________________________________________________________________________________________3
1.2 Product Models & SWL _________________________________________________________________________________4
1.3 Warning Symbols _______________________________________________________________________________________5
2. Intended Use______________________________________________________________________________________6
2.1 Contra Indications ______________________________________________________________________________________6
2.2 General warnings _______________________________________________________________________________________7
3. General Product Description______________________________________________________________________8
3.1 The Dormir 8535 Mattress Replacement Systems _____________________________________________________8
3.2 Product Description_____________________________________________________________________________________8
3.2.1 Identification of Pump Pa rts ___________________________________________________________________________ 9
3.2.2 Identification of Mattress Pa rts ______________________________________________________________________ 10
4. Installation ______________________________________________________________________________________ 11
4.1 Unpacking_____________________________________________________________________________________________ 11
4.2 Assemble the Dormir _________________________________________________________________________________ 11
5. Dormir 8535 MRS Operation____________________________________________________________________ 14
5.1 Pre-Use Routine_______________________________________________________________________________________ 14
5.2 The Dormir 8535 Pump Controls _____________________________________________________________________ 15
5.2.1 8535 Control Panel – PUMP8535 ___________________________________________________________________ 15
5.2.2 8535 Plus Pump Control Panel - PUMP8535CLP ___________________________________________________ 15
5.3 Using the Dormir 8535 MRS __________________________________________________________________________ 16
5.4 User Weight Guide ____________________________________________________________________________________ 17
5.5 Alarms & Indicators ___________________________________________________________________________________ 17
5.6 CPR Valve ______________________________________________________________________________________________ 18
5.7 Mattress Transfer Mode ______________________________________________________________________________ 19
6. Storage & Transport ____________________________________________________________________________ 20
6.1 Preparing the Mattress for storage ___________________________________________________________________ 20
7. Cleaning and Decontamination _________________________________________________________________ 21
7.1 Cleaning Precautions _________________________________________________________________________________ 21
7.2 Cleaning the Mattress _________________________________________________________________________________ 22
7.2.1 Disinfecting the Ma ttress _____________________________________________________________________________ 23
7.2.2 La under ing Ma ttr ess Cover __________________________________________________________________________ 23
7.3 Cleaning the Pump____________________________________________________________________________________ 24
7.3.1 Disinfecting the Pump _______________________________________________________________________________ 24
8. Routine Maintenance ___________________________________________________________________________ 25
8.1 Spare Parts ____________________________________________________________________________________________ 26
8.2 Changing the Air Filter ________________________________________________________________________________ 27
8.3 Changing the Fuses ___________________________________________________________________________________ 28
8.4 Service Manual________________________________________________________________________________________ 29
8.5 Decommissioning Procedures ________________________________________________________________________ 29
8.6 Warranty ______________________________________________________________________________________________ 29
8.7 Product Returns_______________________________________________________________________________________ 29
8.8 Returns Procedure____________________________________________________________________________________ 30
9. Troubleshooting_________________________________________________________________________________ 31
10. Technical Specifications _________________________________________________________________________ 33
10.1 Safe Working Conditions ______________________________________________________________________________ 33
11. Appendix ________________________________________________________________________________________ 35
11.1 Guidance and manufacturer’s declaration – electromagnetic emissions ____________________________ 35
11.2 Guidance and manufacturer’s declaration – electromagnetic immunity_____________________________ 36
12. Dormir 8535 MRS: Weekly Checklist ____________________________________________________________ 39
13. Contact Squirrel Medical ________________________________________________________________________ 40

Sep 2023 Issue 4.5 Page 3 of 41
1. Introduction
1.1 Foreword
Thank you for purchasing a
Squirrel Medical Mattress
Replacement System. In doing so, you have chosen a quality
MRS
which has been designed to provide excellent
functionality in a safe manner.
To ensure the MRS
is always operated correctly and safely
please read this document thoroughly and strictly follow all
the assembly, operating, cleaning and maintenance
instructions.
ALWAYS keep these instructions with the Dormir 8535 MRS for
reference
•Do ensure that you fully read & understand these Instructions for Use
•Do ensure the Dormir 8535 MRS is assembled and installed in accordance with
these Instructions for Use
•Ensure the Dormir 8535 MRS is always used as intended, see 2 -
Intended Use ,
Page 6
•Always ensure the Dormir 8535 MRS
is installed and commissioned as
intended. See 2 - Intended Use , Page 6
•The manufacturer reserves the right to change the information contained in
this document without previous notice

Page 4 of 41 Copyright Squirrel Medical® 2017 - E&OE
1.2 Product Models & SWL
The Dormir 8535 MRS is a pressure redistributing (active) mattress replacement system. It
is comprised primarily of two components – the Pump and the Mattress.
These instructions cover the following models;
Systems
Model Description
Safe Working
Load
DOR090200BD
Dormir 8535 Mattress Replacement System (MRS)
PUMP8535 + DOR303
Active Mattress system for preventing and treating
pressure ulcers. 90cm wide. Comfort settings and
temporary static mode functionality.
MIN: 30KG
MAX: 150KG
DORPLUS090200
Dormir 8535 Plus Mattress Replacement System
(MRS)
PUMP8535CLP + DOR303
Active Mattress system for preventing and treating
pressure ulcers. 90cm wide. Comfort settings and CLP
mode functionality.
MIN: 30KG
MAX: 150KG
Components
Model Description
PUMP8535
Dormir 8535 Pump
The Pump is responsible for the inflation cycle of the system. Includes
temporary static mode functionality.
PUMP8535CLP
Dormir 8535 Plus Pump
The Pump is responsible for the inflation cycle of the system. Includes
Continuous Low Pressure (CLP) functionality.
DOR303
Dormir Mattress, 90cm
This is the standard supplied mattress with the Dormir 8535 MRS.
Size: W 88cm x L 198 cm x D 13cm

Sep 2023 Issue 4.5 Page 5 of 41
1.3 Warning Symbols
WARNINGS
given in this manual identify possible hazards in procedures or
conditions, which if not correctly followed, could result in death, injury or other
serious adverse reactions.
Cautions
given in this manual identify possible hazards in procedures or
conditions, which if not followed, could result in equipment damage or failure,
and indicate moderate risk.
Electrical Hazard symbol indicates a hazard due to electrical voltage, which if
not correctly followed could result in death, serious injury or fire.
Weight Hazard
symbol appears when there is a potential weight related
hazard. This could be a component/packaging weight, or a caution about
Patient/User weight or loading.
Biological Hazard symbols appear wherever there is a risk of infection, cross-
contamination or disinfection.
Indicates the Model Number of the device (Note – this will be different between
pump and mattress)
Indicates the Serial Number of the device (Note – this will be different between
pump and mattress)
Indicates the date when the medical device was manufactured
Indicates the medical device manufacturer
Indicates that the user must read this document (the Instructions for Use)
before using or operating the device.

Page 6 of 41 Copyright Squirrel Medical® 2017 - E&OE
2. Intended Use
The Squirrel Medical Active Mattress Systems are intended to be used as an aid to assist in
the managed treatment and prevention of pressure ulcers when used in conjunction with a
patient care plan and/or pressure ulcer prevention program and must not be considered
or relied upon as an independent curative device.
All patients must be clinically risk assessed before being prescribed any Squirrel Medical
Active Mattress Systems and used with clinical guidance.
The Care Provider is responsible for ensuring that the person(s) setting up and using any
Squirrel Medical Active Mattress Systems are trained and competent in its use.
Support surfaces alone neither prevent nor heal pressure ulcers. They
are to be used as part of a total management plan for the prevention and
treatment of pressure ulcers (NPUAP, EPUAP & PPPIA 2014)
2.1 Contra Indications
The Squirrel Medical Active Mattress Systems provide alternating therapy and
should not be used with patients that have spinal injuries and/or unstable
fractures of the spine. Patients with other fractures and burns should undergo a
thorough medical examination/risk assessment before being prescribed its use.
The clinical evidence relating to the effectiveness of Squirrel Medical Active Mattresses can
be obtained at: www.squirrelmedical.com.
Squirrel Medical Ltd.
Unit 14, Trevol Business Park,
Trevol Road,
Torpoint,
Cornwall,
PL11 2TB
www.squirrelmedical.com
[email protected]om
0845 003 7979

Sep 2023 Issue 4.5 Page 7 of 41
2.2 General warnings
WARNING: DO NOT
modify your Dormir 8535 MRS, its components or any of
its accessories in any way; doing so could result a potential hazard.
Do not use mattress transfer mode with a patient in the bed.
The transport mode is designed to transport a semi inflated mattress NOT a
patient.
Do not use as an overlay.
The Squirrel Dormir 8535 MRS is a mattress replacement and must not be
used as an overlay.
The intended Safe Working Load (SWL) of a Dormir 8535 MRS is up to 150Kg.
There should only every be a single occupant on a Dormir 8535 MRS.
The Dormir 8535 MRS is designed for use only in the UK.
Particular caution should be given to the tampering with the con
trols by
unsupervised children.
The Dormir 8535 MRS is not intended for use in the proximity of high-
frequency surgical equipment and/or defibrillators.
The Dormir 8535 MRS is not intended to be sterile.
Never smoke in bed, and always keep naked flames away from the Dormir
8535 MRS.
External sources of heat or cold (direct sunlight, environmental conditions,
air conditioners, etc.) can impact the surface temperature of the Dormir
8535 MRS.
Do not use an additional mattress ‘Squab’ or mattress extender with the
Dormir System.
In the event of a power cut, do not disconnect the mattress Tubeset from the
Pump. This will rapidly deflate the mattress.

Page 8 of 41 Copyright Squirrel Medical® 2017 - E&OE
3. General Product Description
3.1 The Dormir 8535 Mattress Replacement Systems
The Squirrel Dormir 8535 MRS is a medical support surface designed for persons up to
150Kg, consisting of a mattress with multiple air cells that can be filled and emptied in an
alternating pattern by a Pump with controls to provide regular, frequent, and automatic
changes to the distribution of pressure applied to the body.
UKCA Compliance
The Squirrel Dormir 8535 MRS complies with the ‘UK Medical Device Regulation 2002’
concerning medical devices and has been designed and manufactured to comply with the
following standards:
IEC 60601-1:2005 Medical electrical equipment
0120
Genera l requirements for basic sa fety a nd essentia l performa nce.
EN 60601-1-2:2007 Medical electrical equipment
Genera l requirements for basic sa fety a nd essentia l performa nce.
Collatera l standa rd. Electromagnetic compa tibility. Requirements and tests.
3.2 Product Description
The Dormir 8535 MRS is comprised of two main parts, the mattress and the pump. Both
parts are identifiable by a serial number and part number or name.
The model of compatible Dormir 8535 pumps are: PUMP8535
PUMP8535CLP
The model of this Dormir Mattress is: DOR303
The serial number of the 8535 Pumps can be found on the back of the pump housing.
The mattress serial number can be found on the white label, which is located on the
inside of the mattress base at the head end.

Sep 2023 Issue 4.5 Page 9 of 41
3.2.1 Identification of Pump Parts
Dormir 8535 Pumps (PUMP8535 illustrated)
1 8535 Pump unit 6 Hook Covers
2
Control Panel
7
Air Filter
3
Tube Set Connector Socket
8
Extra Deep Pump Hook
4
Fuse Holders
9
Serial Number Label
5 Standard Pump Hooks (fitted) 10 Power Cord
Pump Model Identification
PUMP8535 - Dormir 8535 Pump PUMP8535CLP - Dormir 8535 Plus Pump
1 10
3 2
4
8
5
6
7
9

Page 10 of 41 Copyright Squirrel Medical® 2017 - E&OE
3.2.2 Identification of Ma ttr ess Parts
Dormir Mattress
1
Dormir Mattress Top Cover
5
Transport Cap
2
Tube Set
6
“O ” R in g
3 CPR Valve 7 Air Cells
4
Tube Set Connector Plug
8
Foam Mattress Base
1
2
3
8
7
4
6
5

Sep 2023 Issue 4.5 Page 11 of 41
4. Installation
4.1 Unpacking
Carefully open the boxes and unpack all components.
While unpacking, be aware some of the larger components are heavy. See
33 Technical Specifications.
If required, please take precautions before
attempting to lift or move any items.
To avoid danger of suffocation, keep packaging and plastic bags away from
babies and children.
4.2 Assemble the Dormir
1
Check that you have the parts
1 x Dormir Mattress
1 x Squirrel pump 8535 or 8535 Plus
1 x Instructions for Use
1 x Standard Pump Hook (pre-attached to pump)
1 x Extra Deep Pump Hook
2
Mount the pump to the foot board of the bed
Unfold the Standard Pump Hooks and hang the
pump over the foot board of the bed. It should be a
snug fit. If they are too loose there is a risk of the
pump falling to the floor and suffering impact
damage.
2b
OPTIONAL STEP – Exchange as required
If the Standard Pump Hooks are not deep enough
to fit the footboard of your bed
, fit the optional
Extra Deep Pump Hook.
Remove 8 x screws in hook covers, illustrated
Remove hook covers
Exchange Pump Brackets as required
Replace covers and all 8 screws securely.

Page 12 of 41 Copyright Squirrel Medical® 2017 - E&OE
Each time the Dormir 8535 MRS
is set up, specific attention must be drawn to
any potential dangers which can occur despite correct operation. Before putting
the Dormir 8535 MRS into service for the first time, the Instructions for Use must
be read conscientiously and in detail by the User / Care personnel.
3
Fit the Mattress
Correct Mattress orientation on a Bed 
Position the Mattress onto the bed with the tube set towards the foot end of the bed.
Also, the print on the mattress should be face up, with the image of ‘feet’ towards the
foot end.
Correct Mattress strap locations 
Secure the mattress on to the bed frame using the black nylon straps that are located
on the mattress base (shown in
RED
, above)
. Ensure that the straps do not impede
moving parts. Pull straps to tighten and tuck the loose end of the nylon strap up and out
of the way. Once fitted, check that the Bed still profiles without the straps snagging on
any framework.
Foot
End
Head
End

Sep 2023 Issue 4.5 Page 13 of 41
Make sure tha t the power cable a nd tube set a re routed so it does not snag the bed or
cause a trip hazard.
NEVER
route the tube set on the floor between the castors at the Head or Foot
Ends of an adjustable height Bed. Doing so and raising a bed will pull the tubes
apart and damage your unit.
ALWAYS
route any cabling around the sides of the bed, or around the castors
4
Connect the Pump and Mattress
Push the male tube set connector into the female
port (situated at the side of the pump) until it clicks
into place. To detach simply press the outside of the
tube set connector and pull outwards. Never
release the tube set connector whilst a patient is on
the mattress.
5
Check CPR Valve
Ensure that the CPR valve on the tube set is closed.
To do this, press the plastic caps attached to the
yellow CPR tag down tightly onto the red connector
opening in the tube set.
6
Check Mattress Assembly
Ensure that the mattress cover is zipped into place.
There are zips all the way around the mattress
cover, and they should all be fastened.
7
Setup Complete!
Plug the pump into a power socket ensuring
that electric cables are routed so they do not
pose a trip hazard.

Page 14 of 41 Copyright Squirrel Medical® 2017 - E&OE
5. Dormir 8535 MRS Operation
5.1 Pre-Use Routine
Each time after you have set up the Dormir 8535 MRS, check the following before
proceeding with normal operation:
Pre-Use Checklist
1 Check that these Instructions for Use (IFU) are easily accessible.

2 Check that the pump hooks are the correct size for the footboard and that
the pump is attached to the footboard of the bed.

3 The power cable is not being strained, cut or crushed. Also check it has not
been damaged prior to use.

4 The pump has power.

5 The pump is set to a reasonable comfort setting.

6 The mattress is attached correctly to the bed frame and
check that the
mattress straps are not impeding moving parts of the bed.

7 Check that the CPR valve is closed.

8 Check that the tube set connector that attaches to pump is sealed. A click
should be heard when the connector is inserted correctly.

9 Check the mattress tubing is not damaged, and is routed correctly without
kinks.

10 The mattress cells are inflating alternately.

11 The Power Failure Alarm Sounds

The Power Failure Alarm must be tested at least once per year, and also after
any prolonged period of storage before commissioning the Pump for use. See
5.5 - Alarms & Indicators, Page 17.

Sep 2023 Issue 4.5 Page 15 of 41
5.2 The Dormir 8535 Pump Controls
5.2.1 8535 Control Panel – PUMP8535
5.2.2 8535 Plus Pump Control Panel - PUMP8535CLP
1 On / Off Button This button toggles the power off and on.
2 Comfort Adjust Buttons These buttons set the pressure in the mattress.
3 Comfort Level Indicator These lights indicate the current Comfort level setting.
4 Normal LED (GREEN) This indicator lets the user know that the Mattress is
ready for use.
1
32
6 7 5
42
1
32
6 8 5
42

Page 16 of 41 Copyright Squirrel Medical® 2017 - E&OE
5 Low Pressure LED (RED) This indicator is lit when the pressure in the mattress
is too low.
6 Power Failure Indicator
This indicator will light if there is a mains power
failure.
7 * Alternating/Static Select
Pump Model Dormir 8535 Only PUMP8535
Pressing this button will toggle between alternating
and Static modes of operation.
8 * CLP Mode Select
Pump Model Dormir 8535 Plus Only PUMP8535CLP
Pressing this button will toggle between alternating
and Continuous Low Pressure modes of operation.
5.3 Using the Dormir 8535 MRS
1. Turn on the power at the wall socket, and the pump should begin to run
automatically. Pressing the on/off button on the pump will toggle the pump
between On and Off states. The ‘On/Off’ light should illuminate when running.
2. The Pump will now begin to inflate the Mattress; this initial inflation takes
approximately 20 minutes. The Dormir 8535 MRS is ready for use when the Normal
LED is lit, and when the Low Pressure LED has gone out.
3. The Dormir 8535 (semi automatic) pump is designed with a safe working patient
weight range of 30Kg-150Kg in supine position. There is no weight guide/setting
needed.
Comfort setting: There is adjustment to make the mattress softer or firmer if the
patient desires. Depending on physiology of the patient and the adjustment of the
bed, the care team may want to manually adjust pump to a softer or firmer setting.
The Comfort Level Indicator will indicate softer or firmer setting.
NOTE: The Dormir 8535 MRS has been designed to aid in the managed care and
prevention of pressure ulcers and must be used with sound clinical judgment
4. To use Static Mode (Dormir 8535 MRS only) , press the Alternating/Static Mode button
so that the ‘Static’ LED is illuminated. All the cells will inflate to the current comfort
level, and alternation will stop. To exit Static mode, press the Static/Alternating
mode button again. The Dormir 8535 Pump will automatically revert to Alternating
mode after 20 minutes in Static mode.
5. To use Static Mode (Dormir 8535 Plus MRS only) , press the CLP Mode button so that
the ‘CLP’ LED is illuminated. All the cells will inflate to the current comfort level, and
alternation will stop. To exit CLP mode, press the CLP/Alternating mode button
again. The Dormir 8535CLP Pump will remain in CLP mode until alternating is
reselected.

Sep 2023 Issue 4.5 Page 17 of 41
Ensure all users are familiar with the subtle differences in operation between
the PUMP8535 ‘S tatic’ and PUMP8535CLP ‘CL P’ m od es .
5.4 User Weight Guide
The Dormir 8535 pumps are designed with a safe working patient weight range of 30Kg-
150Kg in prone position. There is no weight guide/setting needed.
The Dormir 8535 MRS
has been designed to aid in the managed care and
prevention of pressure ulcers and must be used with sound clinical judgment.
5.5 Alarms & Indicators
There will be an audible alarm sound for the following reasons:
Power Failure Alarm
In the event of a power failure an audible alarm will sound.
This will be accompanied by the red ‘Failure’ light flashing on the pump control panel.
Check that:
•The power socket has not been turned off.
•The plug has not been pulled out or partially out of the power socket.
•There has not been a general power cut to the building or the patient’s bedroom.
Restore the power by replacing the plug in the socket.
Note - when power is restored the pump will automatically turn itself back on and starts to
re-inflate the mattress to the previous settings.
The Power Failure Alarm must be tested at least once per year, and also after
any prolonged period of storage before commissioning the Pump for use.
TO TEST:
With the Pump powered and operating, switch off at the wall socket. If
no alarm sounds, leave the pump running for 60 minutes to recharge internal
batteries, then repeat the test. If the alarm still fails to sound, inform service
personnel and schedule the Pump for service immediately.
NOTE:
If a replacement pump o
r alternative ma ttress system is not a vailable, the
pump ca n continue to be used providing a qua lified engineer ha s been ca lled to
service the pump and suita ble risk a ssessment ha s be ca rried out. All other pump
features and alarms will continue to operate, but there will be no wa rning of a power
failure!! Regula rly check the pump is powered, and exercise increa sed ca ution while
using.

Page 18 of 41 Copyright Squirrel Medical® 2017 - E&OE
Low Pressure Alarm
In the event of low pressure within the mattress an audible alarm will sound.
This will be accompanied by the Low Pressure light flashing on the pump control panel.
Check that:
•The tube set connector is securely located into the Dormir 8535 Pump and no air is
escaping. Check there are two ‘O’ Rings present on the connector if air is escaping.
•The CPR valve on the tube set is held firmly in place and that no air is escaping.
If the mattress continues to indicate low pressure, it will be unable to alternate
the pressure in the cells. This could lead to a pressure ulcer. The patient should
be transferred to an alternative operational MRS whilst the mattres
s is
inspected and/or repaired.
5.6 CPR Valve
In the event of cardiac arrest:
The CPR is a
mechanism that allows for the rapid
deflation of the mattress. It is within the tube set. It can
be identified by a bright yellow nylon Strap
that is
connected to a valve on the Tube Set.
If the mattress is to be deflated pull the yellow CPR Strap
firmly ensuring that air flows freely from this area.
Press down to seal before each use
In an emergency, pull CPR Strap to open
valves and quickly deflate mattress



Sep 2023 Issue 4.5 Page 19 of 41
5.7 Mattress Transfer Mode
This mode allows for some air to be sealed inside the mattress base allowing the mattress
to be transferred to different locations (e.g. for cleaning and servicing) without deflating.
Do not use mattress transfer mode with a patient in the bed.
The transfer mode must not be used if a patient is using the mattress.
Disconnect the male tube set connector from the pump and clip the transport cap into
place.

Page 20 of 41 Copyright Squirrel Medical® 2017 - E&OE
6. Storage & Transport
When storing the Pump and Mattress, following the guidance below will help to ensure the
working life of the Dormir 8535 MRS. Also see 10 - Technical Specifications, page 33.
Before the Dormir 8535 MRS is stored or transported, please ensure;
The pump and the mattress have been cleaned and are fully dry

Fitted with dust covers

In a clean, dry and well ventilated area

Between -5°C and +70°C

In relative humidity between 10% and 90%

In an atmospheric pressure between 900 hPa to 1010 hPa

6.1 Preparing the Mattress for storage
Turn off the Dormir 8535 Pump.
Unplug the Pump from the power socket.
Clean and disinfect the Mattress and Pump (whilst inflated).
Disconnect the Mattress tube set connector from the pump by pressing the release
arrows on the tube set connector.
Release the black straps that secure the mattress to the bed frame.
Roll the Mattress from the head end towards the foot end gently forcing the air
through the CPR valve.
Leaving the CPR valve open, use the straps on the base of the mattress to tie the
mattress neatly into a roll.
Store the Mattress and Pump.