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

SSeerriiaall nnuummbbeerr
The serial number (A) for your support surface is located on the patient right side of the foot box on the specification label.
Unzip the support surface top cover to access the specification label. The serial number (B) is for the support surface cover.
A
B
2973-009-002 Rev AB.0 7 EN

PPrreevveennttiivvee mmaaiinntteennaannccee
Remove product from service before you perform preventive maintenance inspection. Check all items listed during annual
preventive maintenance for all Stryker Medical products. You may need to perform preventive maintenance checks more
frequently based on your level of product usage. Service only by qualified personnel.
NNoottee
• Clean and disinfect the exterior of the support surface before inspection, if applicable.
• If excessive wear is observed on the cover or the fire barrier, the recommendation is to replace the cover.
Inspect the following items:
All fasteners are secure
Zipper, snaps, and covers (top, bottom, and fire barrier) are free of tears, cuts, holes, or any other damage
Support surface cover labels are legible, adhere, and free of damage
Handles are free of rips or cracks
Power/data cable is free of damage
**Perform a functional test of the IIssoolliibbrriiuumm PE functions
**Perform system diagnostics and confirm there are no errors
*Internal components for signs of stains from fluid ingress or contamination by fully unzipping the cover
Pods do not leak or are not cracked
Hose connections to the manifold and sensor tubes (both ends) are seated
Foam is free from large tears or large gouges
Turn bladders are free of excessive wear and function
Low Air Loss fans rotate freely and are free of debris and dust
Left and right CPR releases function
Both foot box cooling fans rotate and are free of debris and dust
Pump spring mount has visible clearance from the foot box bottom
Listen for abnormal pump vibration and noise level
Clean the foot box intake metal screen
Clean the mesh on the bottom cover
Clean the fan filter screen on the foot box
Standoffs (feet of the foot box) are present
Cable tie is present on the power/data cable
NNoottee
• *A zipper pull tool or equivalent is required to access the internal components of the support surface.
• **You cannot perform these preventive maintenance checks without the footboard, see the PPrrooCCuuiittyy Maintenance
Manual.
• The zipper overlaps at the end and may appear to be misaligned per design.
Replace the following items every two years:
• Top cover assembly
• Bottom cover assembly
EN 8 2973-009-002 Rev AB.0

Product serial number:
Completed by:
Date:
2973-009-002 Rev AB.0 9 EN

BBlloocckk ddiiaaggrraamm
IIssoolliibbrriiuumm wwiirriinngg
2971-022-188
Revive Main Board
2971-022-140
EHDD-021
ES-0670
Size: 5" x 10"
Software
MC51AC256
2971-022-145
DC
Pump
P
T
Revive Sensor Board
2971-021-160
EHDD-023
ES-0671
Size: 2.25" x 6.5"
PP PP
Back Right Back Left
Seat Right Seat Left
PP Turn Left
Turn Right
Inflate
Back Left Inflate
Seat Left Inflate
Turn Left Exhaust
Back Right Inflate
Seat Right Inflate
Turn Right Exhaust
Exhaust
Tilt Sensor
Patient Left
Foot Box
Foot Box
CAN + Power / 6
297100560801
0015-092-000 (retaining nut)
Right CPR
Strap
Switch
/2
2971-022-117
LAL
Fan1
LAL
Fan2
Back Left Exhaust
Back Right Exhaust
Turn Left Inflate
Turn Right Inflate
Seat Left Exhaust
Seat Right Exhaust
J2/6:
PRGM
/2 /2
/2
/2 /2 /2 /2 /2 /2 /2
/4 Fans/4
2971-022-150
SPI via RS-422 /10
Q
CAN /3
297100560802
Software
MC9S08PT60
2971-021-165
PRGM RS-232
/3
Serial
Debug1
24V
5V
Pressure Sensor
P
Legend
Temp Sensor
T
Valve
For Future Use
36V DC 24V DC 12V DC
5V DC
12V
Bed
/3
Serial
Debug2
RS-232 RS-232
COMP
TEMP / 2
T
Left CPR
Strap
Switch
/2
2971-022-117
/2 /2 /2 /2
3.3V DC
/2
/2
D
Add Valve3 Add Valve4
R
J
2971-022-132
2971-022-002
Valve
Manifold
2971-022-006
Mattress Seat Section
/2
2971-021-189
/2
2971-021-189
Earth
Ground
12 to 5V
Linear Regulator
USB1
/2
/2
B
Add Valve1 Add Valve2
FCPR SGCPR
K
X
W
C
A E
V
DC to DC Power Supply
36V to 5,12,24V
297100220910
On board Temp
Sensor
Regulator
Isolation
Isolated CAN Tx
On board
Pressure Sensor
Do not scale from drawing
Sensor Assembly
2971-021-0 33ES-0671
2971-022-162 (Normally Closed)
2971-022-163 (Normally Closed) 2971-022-162 (Normally Closed)
2971-022-164
(Normally Open)
PTC
PTCPTC PTC
PTC
PTC
Resettable Fuse
2971-022-185
2971-022-184 2971-022-183
Cooling
Fan
-12V
Y
PTC
Label
PTC
Low Air Loss
ProCuity
(Integrated)
BED
Main
Controller
Display
Controller
2971-022-188
Cooling
Fan
Y
PTC
36V / 4
Mattress Present tied to
Mattress uC
297100560803
EN 10 2973-009-002 Rev AB.0

PPnneeuummaattiicc
Back/ Thigh
Section
Right
BR
Seat
Section
Right
SR
LEGEND
Exhaust line Pressure Line
ISOLIBRIUM PNEUMATIC DIAGRAM
Back/ Thigh
Section
Left
BL
Seat
Section
Left
SL
Turn
Right
Section
TR
Turn
Left
Section
TL
Valve Manifold
Quick
Disconnect
2971-022-162
VALVE, MB3E1
2971-022-162
VALVE, MB3E1
CPR/Relief
Valve
Quick
Disconnect
2971-022-162
VALVE, MB3E1
2971-022-162
VALVE, MB3E1
CPR/Relief
Valve
Quick
Disconnect
2971-022-163
VALVE, 310 SERIES, NC
CPR/Relief
Valve
2971-022-163
VALVE, 310 SERIES, NC
Quick
Disconnect
2971-022-162
VALVE, MB3E1
2971-022-162
VALVE, MB3E1
CPR/Relief
Valve
Quick
Disconnect
2971-022-162
VALVE, MB3E1
2971-022-162
VALVE, MB3E1
CPR/Relief
Valve
2971-022-164
VALVE, 310 SERIES, NO
Quick
Disconnect
2971-022-163
VALVE, 310 SERIES, NC
2971-022-163
VALVE, 310 SERIES, NC
CPR/Relief
Valve
2971-022-163
VALVE, 310 SERIES, NC
Air Intake/
Exhaust
Thomas
6025SE
24VDC M
Pressure Sensor Board
2973-009-002 Rev AB.0 11 EN

CCiirrccuuiitt bbooaarrddss
PPoowweerr ssuuppppllyy aasssseemmbbllyy
297100220910 Rev AF (Reference only)
C52
C53
J2
C51 C47
C50
C46
C49
C45
C48 C44
R18
C43
TP4
D6
F4
F3
TP5
D5 R17
C42 C41
F2
C38 C40
L3
L2
C37 C39
R16 R14 C36
R15 R13 C35
C33 C32 C34
U2
R10 R11 R12
R9
C31
C30
C28
R8
C29
C27
R7
C26
TP3
C25
FB2
C24
TP2
C23 C22
C19
R6
C21 C20
D4
C18
L1
C17
R5
C16
C15
C13
U1
C12
C14
C11
R4
C9
R3 R2
C10
C8
FB1
D2 R1
D3
TP1
C7 D1
F1
C5 C4
C3
C6
C1
C2
J1
A
+36V
B
+5V
+12V
+24V
GND
ISOLIBRIUM POWER SUPPLY
+24V
297100220910
REV
1
K
K
K
K
1
CD
A
B
C
LLooccaattiioonn VVoollttaaggee PPoossiittiivvee lleeaadd NNeeggaattiivvee lleeaadd LLEEDD iinnddiiccaattoorr
A +12VDC TP5 GND D5
B +5VDC TP4 GND D6
C +24VDC TP3 GND D4 (location E)
D +36VDC TP1 GND D2
EN 12 2973-009-002 Rev AB.0

MMaaiinn ppoowweerr bbooaarrdd aasssseemmbbllyy
2971-022-140 Rev L (Reference only)
2973-009-002 Rev AB.0 13 EN

CCaabbllee aanndd tteesstt ppooiinntt
((LLEEDD)) llooccaattiioonn
VVoollttaaggee PPoossiittiivvee lleeaadd NNeeggaattiivvee lleeaadd DDeessccrriippttiioonn
D43 +5VDC N/A N/A +5VDC from power
supply to main board
D60 +12VDC N/A N/A +12VDC from power
supply to main board
D56 +24VDC N/A N/A +24VDC from power
supply to main board
CPR (left) +5VDC Pin 2 red Pin 3 black +5VDC power out to
CPR switch
CPR (right) +5VDC Pin 2 red Pin 3 black +5VDC power out to
CPR switch
TLI (D30) +24VDC TP11 TP24 GND +24VDC from main
board to solenoid
valve (Turn Left
Inflate)
TLD (D31) +24VDC TP18 TP24 GND +24VDC from main
board to solenoid
valve (Turn Left
Deflate)
TRI (D26) +24VDC TP9 TP24 GND +24VDC from main
board to solenoid
valve (Turn Right
Inflate)
TRD (D27) +24VDC TP16 TP24 GND +24VDC from main
board to solenoid
valve (Turn Right
Deflate)
BLI (D34) +24VDC TP13 TP24 GND +24VDC from main
board to solenoid
valve (Back Left
Inflate)
BLD (D36) +24VDC TP20 TP24 GND +24VDC from main
board to solenoid
valve (Back Left
Deflate)
BRI (D22) +24VDC TP7 TP24 GND +24VDC from main
board to solenoid
valve (Back Right
Inflate)
BRD (D23) +24VDC TP14 TP24 GND +24VDC from main
board to solenoid
valve (Back Right
Deflate)
SLI (D33) +24VDC TP12 TP24 GND +24VDC from main
board to solenoid
valve (Seat Left
Inflate)
EN 14 2973-009-002 Rev AB.0

CCaabbllee aanndd tteesstt ppooiinntt
((LLEEDD)) llooccaattiioonn
VVoollttaaggee PPoossiittiivvee lleeaadd NNeeggaattiivvee lleeaadd DDeessccrriippttiioonn
SLD (D32) +24VDC TP19 TP24 GND +24VDC from main
board to solenoid
valve (Seat Left
Deflate)
SRI (D25) +24VDC TP8 TP24 GND +24VDC from main
board to solenoid
valve (Seat Right
Inflate)
SRD (D24) +24VDC TP15 TP24 GND +24VDC from main
board to solenoid
valve (Seat Right
Deflate)
IN (D28) +24VDC TP10 TP24 GND +24VDC from main
board to solenoid
valve (Air Intake)
EX (D29) +24VDC TP17 TP24 GND +24VDC from main
board to solenoid
valve (Air Exhaust)
J14 +12VDC Pin 1 red Pin 6 black +12VDC out to sensor
board from main
board
J6 +24VDC Pin 1 yellow Pin 2 black +24VDC out to
compressor from
main board (variable
voltage) - D65 =
24.4% - D66 = 48.8%
- D67 = 73.2% - D68 =
97.6% - D71 = 110%
2973-009-002 Rev AB.0 15 EN

CCaabblleess
FFaannss aanndd ccaabbllee aasssseemmbbllyy
2971-021-188 Rev C (Reference only)
IItteemm CCoolloorr
1 Red
2 Blue
SSPPII ccaabblleess ((mmaaiinn bbooaarrdd ttoo ffoooott bbooxx)) aasssseemmbbllyy
2971-022-132 Rev D (Reference only)
IItteemm CCoolloorr
1 Red
6 Black
2 Black
3 Green
4 Black
5 White
7 Blue
8 Black
9 Brown
10 Black
JJuummppeerr ffrroomm bbeedd ttoo IIssoolliibbrriiuumm PPEE mmaattttrreessss bbooxx ccaabbllee aasssseemmbbllyy -- 229977110000556600880011
Rev AD
EN 16 2973-009-002 Rev AB.0