Squirrel Medical Dormir Digital MRS Instructions For Use Manual

Squirrel Dormir Digital MRS
Instructions for Use
IMPORTANT!
Read the instructions in this booklet thoroughly prior to use.
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Copyright Squirrel Medical® 2017 - E&OE
Contents
1. Introduction ____________________________________________________________________________ 3
1.1 Foreword ________________________________________________________________________________________________ 3
1.2 Warning Symbols _______________________________________________________________________________________ 4
2. Intended Use ___________________________________________________________________________ 5
2.1 Contra Indications ______________________________________________________________________________________ 5
2.2 General warnings _______________________________________________________________________________________ 6
3. General Product Description ___________________________________________________________ 7
3.1 The Dormir Digital System ______________________________________________________________________________ 7
3.2 Product Description _____________________________________________________________________________________ 7
3.2.1 Identification of Pump Parts _________________________________________________________________ 8
3.2.2 Identification of Mattress Parts ______________________________________________________________ 9
4. Installation _____________________________________________________________________________ 10
4.1 Unpacking _____________________________________________________________________________________________ 10
4.2 Assemble the Dormir _________________________________________________________________________________ 10
5. Dormir Digital MRS Operation _________________________________________________________ 13
5.1 Pre-Use Routine _______________________________________________________________________________________ 13
5.2 The Dormir Digital Controls ___________________________________________________________________________ 14
5.3 Using the Dormir Digital MRS _________________________________________________________________________ 14
5.4 User Weight Guide ____________________________________________________________________________________ 15
5.5 Alarms & Indicators ___________________________________________________________________________________ 15
5.6 CPR Valve ______________________________________________________________________________________________ 16
5.7 Mattress Transfer Mode ______________________________________________________________________________ 17
6. Storage & Transport ___________________________________________________________________ 18
6.1 Preparing the Mattress for storage ___________________________________________________________________ 18
7. Cleaning and Decontamination ________________________________________________________ 19
7.1 Cleaning Precautions _________________________________________________________________________________ 19
7.2 Cleaning the Mattress _________________________________________________________________________________ 20
7.2.1 Disinfecting the Mattress ____________________________________________________________________ 21
7.2.2 Laundering Mattress Cover __________________________________________________________________ 21
7.3 Cleaning the Pump ____________________________________________________________________________________ 22
7.3.1 Disinfecting the Pump _______________________________________________________________________ 22
8. Routine Maintenance __________________________________________________________________ 23
8.1 Spare Parts ____________________________________________________________________________________________ 24
8.2 Changing the Air Filter ________________________________________________________________________________ 25
8.3 Changing the Fuses ___________________________________________________________________________________ 26
8.4 Service Manual ________________________________________________________________________________________ 27
8.5 Decommissioning Procedures ________________________________________________________________________ 27
8.6 Warranty ______________________________________________________________________________________________ 27
8.7 Product Returns_______________________________________________________________________________________ 27
8.8 Returns Procedure ____________________________________________________________________________________ 28
9. Troubleshooting _______________________________________________________________________ 29
10. Technical Specifications________________________________________________________________ 31
10.1 Safe Working Conditions ______________________________________________________________________________ 31
11. Appendix ______________________________________________________________________________ 33
11.1 Guidance and manufacturer’s declaration – electromagnetic emissions ____________________________ 33
11.2 Guidance and manufacturer’s declaration – electromagnetic immunity _____________________________ 34
12. Contact Squirrel Medical _______________________________________________________________ 37
March 2019
Issue 1.9
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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.
These instructions cover the following models;
Model
Description
Safe Working
Load
DOR090200BD
Dormir Digital Mattress Replacement System
The Dormir Digital MRS is a pressure redistributing
(active) mattress replacement system, with a Semi-
Automatic digital pump.
MAX: 150KG
ALWAYS keep these instructions with the Dormir Digital MRS for
reference
Do ensure that you fully read & understand these Instructions for Use
Do ensure the Dormir Digital is assembled and installed in accordance with
these Instructions for Use
Ensure the Dormir Digital MRS is always used as intended, see 2 - Intended
Use, Page 5
Always ensure the Dormir Digital MRS is installed and commissioned as
intended. See 2 - Intended Use, Page 5
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Copyright Squirrel Medical® 2017 - E&OE
1.2 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.
March 2019
Issue 1.9
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2. Intended Use
The Dormir Digital Mattress Replacement System is 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 the Dormir Digital
Mattress Replacement System and used with clinical guidance.
The Care Provider is responsible for ensuring that the person(s) setting up and using the
Dormir System 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
SPINAL INJURIES
The Dormir Digital MRS provides 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 this product can be found in Squirrel
Medicals Guide to Pressure Area Care. This can be obtained at: www.squirrelmedical.com
Web:
www.squirrelmedical.com
Email:
sales@squirrelmedical.com
Tel:
0044 (0)845 003 7979
Address:
Squirrel Medical Ltd, Road Five, Winsford Industrial Estate, Winsford, Cheshire, CW7 3RB
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Copyright Squirrel Medical® 2017 - E&OE
2.2 General warnings
WARNING: DO NOT modify your Dormir Digital 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 Digital MRS is a mattress replacement and must not be
used as an overlay.
The intended Safe Working Load (SWL) of a Dormir Digital MRS is up to
150Kg.
The Dormir Digital MRS’s are designed for use only in the UK and Ireland.
Particular caution should be given to the tampering with the controls by
unsupervised children.
The Dormir Digital is not intended for use in the proximity of high-frequency
surgical equipment and/or defibrillators.
The Dormir Digital MRS is not intended to be sterile.
Never smoke in bed, and always keep naked flames away from the Dormir
Digital MRS.
March 2019
Issue 1.9
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3. General Product Description
3.1 The Dormir Digital System
The Squirrel Dormir Digital 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 Digital Pump with controls to provide regular, frequent, and
automatic changes to the distribution of pressure applied to the body.
CE Compliance
The Squirrel Dormir Digital MRS complies with European Directive 93/42/EEC concerning
medical devices and has been designed and manufactured to comply with the following
standards:
IEC 60601-1:2005 Medical electrical equipment
General requirements for basic safety and essential performance.
EN 60601-1-2:2007 Medical electrical equipment
General requirements for basic safety and essential performance.
Collateral standard. Electromagnetic compatibility. Requirements
and tests.
3.2 Product Description
The Dormir Digital 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 this Dormir Digital pump is: PUMP8535
The model of this Dormir Mattress is: DOR303
The serial number of the 8535 Pump 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.
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Copyright Squirrel Medical® 2017 - E&OE
3.2.1 Identification of Pump Parts
Dormir Digital Pump
1
Dormir Digital 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 with Plug
1
10 3 2 4 8 5 6 7 9
March 2019
Issue 1.9
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3.2.2 Identification of Mattress Parts
Dormir Mattress
1
Dormir Mattress Top Cover
5
Transport Cap
2
Tube Set
6
“O” Ring
3
CPR Valve
7
Air Cells
4
Tube Set Connector Plug
8
Foam Mattress Base
1 2 3 8 7 4 6 5
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Copyright Squirrel Medical® 2017 - E&OE
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
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 Digital Pump 8535
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.
March 2019
Issue 1.9
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Each time the Dormir Digital MRS is set up, specific attention must be drawn to
any potential dangers which can occur despite correct operation. Before putting
the Dormir Digital 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
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Copyright Squirrel Medical® 2017 - E&OE
Make sure that the power cable and tube set are 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.
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