Stryker Isolibrium PE User manual

IIssoolliibbrriiuumm®® PPEE ssuuppppoorrtt ssuurrffaaccee
MMaaiinntteennaannccee MMaannuuaall
297300000000
EN
2973-009-002 Rev AB.0 2021/06
2797

SSyymmbboollss
Refer to instruction manual/booklet
Consult instructions for use
General warning
Caution
Patient stability and siderails coverage may be compromised with the use of an overlay
Warning; electricity
Indicates that this product does not contain toxic and hazardous substances or elements above
the maximum concentration of all 6 values defined by the China RoHS legislation. This product is
an environmentally friendly product which can be recycled and reused.
Catalogue number

Serial number
European medical device
2797
CE mark
Authorized representative in the European Community
 
For US Patents see www.stryker.com/patents
Manufacturer
Safe working load
Mass of equipment
IIPPXX44 Protection from liquid splash
Class II electrical equipment: equipment in which protection against electric shock does not rely
on basic insulation only, but in which additional safety precautions such as double insulation or
reinforced insulation are provided, there being no provision for protective earthing or reliance
upon installation conditions.
Defibrillation proof type B applied part
2973-009-002 Rev AB.0 EN

87VL
Medical Equipment recognized by UL LLC with respect to electric shock, fire, and mechanical
hazards in accordance with ANSI/AAMI ES60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012,
A2:2010/(R)2012, and CAN/CSA-C22.2 No. 60601-1 (2008)
In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic
Equipment (WEEE) as amended, this symbol indicates that the product should be collected
separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor
for disposal information. Ensure infected equipment is decontaminated prior to recycling.
Wash by hand
Do not tumble dry
Do not dry-clean
Do not iron
CL
Chlorinated bleach
Keep dry
Stacking limit by number
This side up
Fragile
Do not use sharp objects to open the package
Center of gravity/weight distribution
Two person lift
EN 2973-009-002 Rev AB.0

TTaabbllee ooff CCoonntteennttss
Warning/Caution/Note Definition ..............................................................................................................................2
Summary of safety precautions ................................................................................................................................2
Introduction for service .............................................................................................................................................3
Product description .................................................................................................................................................3
Indications for use...................................................................................................................................................3
Clinical benefits ......................................................................................................................................................3
Contraindications....................................................................................................................................................3
Expected service life ...............................................................................................................................................3
Disposal/recycle .....................................................................................................................................................3
Specifications .........................................................................................................................................................4
European REACH...................................................................................................................................................4
Product illustration ..................................................................................................................................................6
Contact information.................................................................................................................................................6
Serial number .........................................................................................................................................................7
Preventive maintenance ...........................................................................................................................................8
Block diagram .........................................................................................................................................................10
Isolibrium wiring....................................................................................................................................................10
Pneumatic............................................................................................................................................................11
Circuit boards..........................................................................................................................................................12
Power supply assembly.........................................................................................................................................12
Main power board assembly ..................................................................................................................................13
Cables.....................................................................................................................................................................16
Fans and cable assembly ......................................................................................................................................16
SPI cables (main board to foot box) assembly .........................................................................................................16
Jumper from bed to Isolibrium PE mattress box cable assembly - 297100560801 ......................................................16
Troubleshooting ......................................................................................................................................................17
Service ....................................................................................................................................................................22
Protecting against electrostatic discharge (ESD) .....................................................................................................22
Cover replacement, top .........................................................................................................................................22
Cover replacement, bottom....................................................................................................................................23
Pod assembly replacement....................................................................................................................................25
Accessing the foot box cover .................................................................................................................................28
Solenoid valve replacement...................................................................................................................................31
Power board replacement......................................................................................................................................32
Main board replacement........................................................................................................................................33
Power/data cable connector replacement ...............................................................................................................34
Power/data cable replacement...............................................................................................................................35
Pump assembly replacement.................................................................................................................................37
Low Air Loss (LAL) fan replacement .......................................................................................................................39
Foot box cooling fan replacement...........................................................................................................................41
Sensor board replacement.....................................................................................................................................42
Resonator replacement .........................................................................................................................................43
Turn bladder assembly replacement.......................................................................................................................45
Isolibrium PE assembly ..........................................................................................................................................47
Footbox assembly...................................................................................................................................................54
Pump assembly kit - 297307000001 ......................................................................................................................65
Valve manifold assembly kit - 2971-700-007 .........................................................................................................66
EMC Information.....................................................................................................................................................67
Recycling passport .................................................................................................................................................69
297300220008 .....................................................................................................................................................69
297300220008........................................................................................................................................................70
297300220008........................................................................................................................................................71
2973-009-002 Rev AB.0 1 EN

WWaarrnniinngg//CCaauuttiioonn//NNoottee DDeeffiinniittiioonn
The words WWAARRNNIINNGG,CCAAUUTTIIOONN, and NNOOTTEE carry special meanings and should be carefully reviewed.
WWAARRNNIINNGG
Alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe
potential serious adverse reactions and safety hazards.
CCAAUUTTIIOONN
Alerts the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the
user or patient or damage to the product or other property. This includes special care necessary for the safe and effective
use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse.
NNoottee -- Provides special information to make maintenance easier or important instructions clearer.
SSuummmmaarryy ooff ssaaffeettyy pprreeccaauuttiioonnss
Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.
CCAAUUTTIIOONN
• Always use ESD protective equipment before you open antistatic bags and service electronic parts.
• Do not place unprotected circuit boards on the floor.
• Avoid stacking or placing equipment adjacent with other equipment to prevent improper operation of the product. If such
use is necessary, carefully observe stacked or adjacent equipment to make sure that they operate properly.
• The use of accessories, transducers, and cables, other than those specified or provided by the manufacturer, could
result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation.
EN 2 2973-009-002 Rev AB.0

IInnttrroodduuccttiioonn ffoorr sseerrvviiccee
This manual assists you with the service of your Stryker product. Read this manual to service this product. This manual
does not address the operation of this product. See the Operations Manual for operating and use instructions. To view your
Operations Manual online, see https://techweb.stryker.com/.
PPrroodduucctt ddeessccrriippttiioonn
The Stryker Model 297300000000 IIssoolliibbrriiuumm PE is a powered support surface with features that provide pressure
redistribution, low air loss, turn assist, max inflate, and lateral rotation. The IIssoolliibbrriiuumm PE powered support surface is for
use with the Stryker Model 300900000000 PPrrooCCuuiittyy™ bed frame.
IInnddiiccaattiioonnss ffoorr uussee
The Stryker Model 297300000000 IIssoolliibbrriiuumm PE support surface is intended to assist in the prevention and treatment of all
pressure injury or pressure ulcers (includes all stages, unstageable and deep tissue pressure injury). As a
recommendation, healthcare professional should complete a clinical evaluation of risk factors and skin assessments. The
intended users is both healthcare HCPs (nurses, nurse aids, and medical doctors), transporters, and human patients. This
product is for use by human patients in a health delivery organization (HDO).
The IIssoolliibbrriiuumm PE patient-specific immersion is intended to assist in the management of microclimate of the patient’s skin,
patient repositioning, and the support in prevention of early mobility and pulmonary complications.
The IIssoolliibbrriiuumm PE powered support surface is not intended for use in or with:
• Oxygen rich environments
• Sterile environments
• Home care or long-term care facility settings
• Behavioral health populations
CClliinniiccaall bbeenneeffiittss
Assists in the prevention and treatment of all pressure ulcers or pressure injuries
CCoonnttrraaiinnddiiccaattiioonnss
IIssoolliibbrriiuumm PPEE is contraindicated for use on patients with:
• Unstable fractures
• Unstable spinal cord injuries
EExxppeecctteedd sseerrvviiccee lliiffee
IIssoolliibbrriiuumm PE support surface has a five year expected service life under normal use, conditions, and with appropriate
periodic maintenance.
IIssoolliibbrriiuumm PE covers (top and bottom) have a two year expected service life under normal use, and conditions.
DDiissppoossaall//rreeccyyccllee
Always follow the current local recommendations and/or regulations governing environmental protection and the risks
associated with recycling or disposing of the equipment at the end of its useful life.
2973-009-002 Rev AB.0 3 EN

SSppeecciiffiiccaattiioonnss
NNoottee -- Do not exceed the safe
working load of the product.
460 lb 208.6 kg
Minimum patient weight 60 lb 27.2 kg
Length 84 in. 213.4 cm
Width 35 in. 88.9 cm
Thickness 8 - 10.5 in. 20.3 - 26.7 cm
Weight < 90 lb < 40.8 kg
Electrical safety IEC 60601-1-2 Ed. 4.0b:2014, BS EN 60601-1-2:2015, IEC 60601-1-2 Ed. 3.0
b:2007. CAN/CSA C22.2 NO. 60601-1-2:16, AIM 7351731
DC Voltage 36V +/- 10%
Current 3.35A
Maximum noise level 50 dBA
Flammability 16CFR 1632, 16CFR 1633, California Technical Bulletin 129, BFD IX-11, BS
6807:2006 Clause 9, Method 27.7-1979 of CAN 2-4.2 M77, BS EN 597-1:2015,
BS EN 597-2:2015, Italy UNI 9175:2008 Clause 9
Compatible bed frame Model 300900000000 PPrrooCCuuiittyy bed frame
Stryker reserves the right to change specifications without notice.
EEnnvviirroonnmmeennttaall ccoonnddiittiioonnss OOppeerraattiioonn SSttoorraaggee aanndd ttrraannssppoorrttaattiioonn
Ambient temperature
86 °F
(30 °C)
50 °F
(10 °C)
140 °F
(60 °C)
-40 °F
(-40 °C)
Relative humidity (non-condensing)
95%
10%
Atmospheric pressure
1060 hPa
700 hPa
EEuurrooppeeaann RREEAACCHH
In accordance with the European REACH regulation and other environmental regulatory requirements, the components that
contain declarable substances are listed.
DDeessccrriippttiioonn NNuummbbeerr SSuubbssttaannccee ooff vveerryy hhiigghh ccoonncceerrnn
((SSVVHHCC)) cchheemmiiccaall nnaammee
Sensor assembly 2971-021-033 1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-
triazinane-2,4,6-trione (TGIC)
2-Ethoxyethyl acetate
EN 4 2973-009-002 Rev AB.0

DDeessccrriippttiioonn NNuummbbeerr SSuubbssttaannccee ooff vveerryy hhiigghh ccoonncceerrnn
((SSVVHHCC)) cchheemmiiccaall nnaammee
Cadmium
Diboron-trioxide
Lead-monoxide
Main board PCB assembly 2971-022-140 Cadmium
Diboron-trioxide
Lead-monoxide
Footbox bottom weldment 2971-022-009 Tris(2,3-epoxypropyl) isocyanurate
Footbox top 2971-022-200 Tris(2,3-epoxypropyl) isocyanurate
Pump assembly 297300220010 Lead-steel
Lead-brass
Lead-aluminum
Power supply 297100220910 Lead (Pb) Cas#7439-92-1
2973-009-002 Rev AB.0 5 EN

PPrroodduucctt iilllluussttrraattiioonn
A
H
F
C
G
C
C
B
D
D
E
A Head end F Top support surface cover
B Foot end G Bottom support cover
CD-ring H Retainer strap (D-ring not shown)
DCPR strap I Four handles on the support surface (not
shown)
EPower/data cable
CCoonnttaacctt iinnffoorrmmaattiioonn
Contact Stryker Customer Service or Technical Support at: 1-800-327-0770.
Stryker Medical
3800 E. Centre Avenue
Portage, MI 49002
USA
NNoottee -- The user and/or the patient should report any serious product-related incident to both the manufacturer and the
Competent authority of the European Member State where the user and/or patient is established.
To view your operations or maintenance manual online, see https://techweb.stryker.com/.
Have the serial number (A) of your Stryker product available when calling Stryker Customer Service or Technical Support.
Include the serial number in all written communication.
EN 6 2973-009-002 Rev AB.0