Stryker Isolibrium 2971, Isolibrium 2972 Operation Manual

Isolibrium™ Support Surface

Integrated with InTouch® FL27 (2131 / 2141 / 2151 / 2152)

version 4.0

2971 2972

Operations Manual

International - EN | FR

2017/08 C.3

2971-209-001 REV C

www.stryker.com

sample text

Symbols

Refer to instruction manual/booklet

Operating instructions/Consult instructions for use

General warning

Caution

Warning; electricity

Alternating current

Catalogue number

English

IPX4

87VL

Serial number

Manufacturer

Date of manufacture

Safe working load

Mass of equipment

Protective earth terminal

Protection from liquid splash

Defibrillation proof type B applied part

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, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately. Contact your local distributor for disposal information.

www.stryker.com 2971-209-001 REV C

English

Symbols

Wash by hand

Do not tumble dry

Do not dry-clean

Do not iron

Allow to completely air dry

Chlorinated bleach

For US Patents see www.stryker.com/patents

Pressure redistribution

Moisture management, Low Air Loss

Lateral rotation

Shear

Turn assist

2971-209-001 REV C www.stryker.com

Isolibrium™ Support Surface

Integrated with InTouch® FL27 (2131 / 2141 / 2151 / 2152)

version 4.0

2971 2972

Operations Manual

2017/08 C.3

2971-209-001 REV C

www.stryker.com

sample text

Symbols

Refer to instruction manual/booklet

Operating instructions/Consult instructions for use

General warning

Caution

Warning; electricity

Alternating current

Catalogue number

English

IPX4

87VL

Serial number

Manufacturer

Date of manufacture

Safe working load

Mass of equipment

Protective earth terminal

Protection from liquid splash

Defibrillation proof type B applied part

www.stryker.com 2971-209-001 REV C

English

Symbols

Wash by hand

Do not tumble dry

Do not dry-clean

Do not iron

Allow to completely air dry

Chlorinated bleach

For US Patents see www.stryker.com/patents

Pressure redistribution

Moisture management, Low Air Loss

Lateral rotation

Shear

Turn assist

2971-209-001 REV C www.stryker.com

Table of Contents

Warning/Caution/Note Definition ............................................................................................................... 1-2

Summary of safety precautions........................................................................................................... 1-2

Introduction........................................................................................................................................... 1-4

Product description........................................................................................................................... 1-4

Intended use ................................................................................................................................... 1-4

Expected service life......................................................................................................................... 1-4

Contraindications ............................................................................................................................. 1-5

Specifications.................................................................................................................................. 1-5

Contact information .......................................................................................................................... 1-6

Serial number location ...................................................................................................................... 1-6

Date of manufacture......................................................................................................................... 1-7

Product illustration............................................................................................................................ 1-8

Isolibrium features............................................................................................................................ 1-8

Installation .......................................................................................................................................... 1-10

Operation ........................................................................................................................................... 1-13

Applying the linens ......................................................................................................................... 1-13

Positioning a patient on the support surface......................................................................................... 1-13

Managing incontinence and drainage ................................................................................................. 1-14

Activating and resetting CPR ............................................................................................................ 1-14

Relocating the support surface ......................................................................................................... 1-15

Transferring of patient from one patient support platform to another ......................................................... 1-16

Storing the product ......................................................................................................................... 1-16

Cleaning............................................................................................................................................. 1-17

Disinfecting......................................................................................................................................... 1-18

Preventive maintenance ........................................................................................................................ 1-19

Cover replacement, top ................................................................................................................... 1-20

Quick reference replacement parts.......................................................................................................... 1-22

EMC Information .................................................................................................................................. 1-23

Warranty ............................................................................................................................................ 1-27

Warranty exclusion and damage limitations ......................................................................................... 1-27

To obtain parts and service .............................................................................................................. 1-27

Return authorization........................................................................................................................ 1-27

Damaged product........................................................................................................................... 1-28

International warranty clause ............................................................................................................ 1-28

English

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Warning/Caution/Note Definition

English

The words WARNING, CAUTION, and NOTE carry special meanings and should be carefully reviewed.

WARNING

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.

CAUTION

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.

Note: Provides special information to make maintenance easier or important instructions clearer.

Summary of safety precautions

Carefully read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel.

WARNING

• Risk of Shock. This product must only be connected to a supply mains with protective earth. Grounding reliability can be achieved only when a hospital grade receptacle is used.

• Explosion risk. This product is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide other than nasal, mask type, or half bed-length tent type.

• Do not move the support surface without assistance.

• Do not operate the support surface without the Isolibrium top and bottom covers and linens.

• Always position the support surface on the InTouch bed frame to that the support surface does not contact the headboard.

• Do not use when gaps between the support surface and the bed frame are present to prevent the risk of entrapment. Only use the Isolibrium support surface with InTouch bed frames.

• Do not attach the power cord to any moving parts of the InTouch bed frame. Improper routing of the power cord could cause the risk of electric shock, pinching the power cord, or interfere with bed functions.

• Always confirm proper functionality of the scale system after you install the support surface to prevent product malfunction.

• Do not use extension cords with Isolibrium. It is only intended to be powered by InTouch with the power cord supplied.

• Always use the power source provided by the InTouch foot end auxiliary power outlet with Isolibrium.

• Always make sure that the operator has access to the CPR straps.

• Do not stick needles into a support surface through the support surface cover. Holes may allow body fluids to enter the inside (inner core) of the support surface and could cause cross-contamination, product damage, or product malfunction.

• Do not use fitted sheets with this support surface.

• Always center the patient on the support surface. Align the patient’s head toward the headboard before starting functions. Check the patient frequently to make sure that you maintain the proper positioning.

• Always make sure that the tubing and wiring that is connected to the patient is long enough, stable, and secure during Lateral Rotation or Turn Assist.

• Always raise all of the InTouch bed siderails before starting Turn Assist or Lateral Rotation functions.

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Warning/Caution/Note Definition

Summary of safety precautions (Continued)

WARNING (CONTINUED)

• Do not exceed the safe working load of the Isolibrium support surface. Excess weight could cause unpredictable safety and performance of this system.

• Always use extra caution when reading radiology images taken of a patient on a support surface because internal components can cause artifacts and distort readings.

• Always monitor the patient condition at regular intervals for patient safety.

• Do not use the support surface as a transfer device to avoid the risk of patient injury.

• Do not immerse the support surface or foot box in cleaning or disinfectant solutions.

• Do not allow fluid to pool on the support surface. Fluids may cause degradation of components and may cause unpredictable safety and performance of this product.

• Always inspect the support surface covers (top and bottom) for tears, punctures, excessive wear, and misaligned zippers as you clean the covers. If the cover is compromised, remove the support surface from service immediately and replace the cover to prevent cross-contamination.

• Always perform preventive maintenance based on the usage level of the product. An increase in usage which may include more frequent cleaning and disinfection, may adversely affect the life of the support surface.

• Always disinfect the support surface between patients, to avoid the risk of cross-contamination and infection.

• Always make sure that you wipe each product with clean water and thoroughly dry each product after cleaning or disinfecting. Some cleaning and disinfecting agents are corrosive in nature and may cause damage to the product if you use them improperly. If you do not properly rinse and dry the product, a corrosive residue may be left on the surface of the product that could cause premature degradation of critical components. Failure to follow these cleaning or disinfecting instructions may void your warranty.

• Always unplug the product power cord before cleaning or disinfecting to avoid the risk of shock.

• Do not service or perform maintenance while the product is in use.

English

CAUTION

• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in this manual.

• Do not modify the product or any components of the product. Modifying the product can cause unpredictable operation resulting in injury to patient or operator. Modifying the product also voids its warranty.

• Do not allow sharp objects to come into contact with the support surface that could puncture, tear, or cut the cover.

• Do not allow sharp edges from the X-ray plate to come in contact with the support surface cover. The recommendation is you cover the X-ray plate with a pillow case or other device before placement under the patient. If damaged, remove the support surface cover from service immediately to prevent cross contamination.

• Do not iron, dry-clean, or tumble dry the support surface covers.

• Do not power wash the support surface.

• Always completely dry the support surface covers before storing, adding linens, or placing a patient on the surface.

• Do not over expose the covers to higher concentration disinfectant solutions as these may degrade the covers.

• Do not use accelerated hydrogen peroxides or quaternaries that contain glycol ethers as they may damage the cover or the CPR strap print.

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Introduction

English

This manual assists you with the operation or maintenance of your Stryker product. Read this manual before operating or maintaining this product. Set methods and procedures to educate and train your staff on the safe operation or maintenance of this product.

CAUTION

• Improper usage of the product can cause injury to the patient or operator. Operate the product only as described in this manual.

Notes

• This manual is a permanent part of the product and should remain with the product even if the product is sold.

• Stryker continually seeks advancements in product design and quality. This manual contains the most current product information available at the time of printing. There may be minor discrepancies between your product and this manual. If you have any questions, contact Stryker Customer Service or Technical Support at 1-800-327-0770.

Product description

Isolibrium™, Stryker model 2971/2972, is a powered support surface with features that provide Pressure Redistribution, Low Air Loss, and Lateral Rotation. Isolibrium is for use with the InTouch® (revisions 4.0 or higher software) bed frame. Isolibrium and InTouch are an integrated bed and surface system that caregivers use to assist in patient care.

Intended use

The Isolibrium support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury). Before implementing Isolibrium, a healthcare professional should complete a clinical evaluation of risk factors and skin assessments. The Isolibrium patient-specific immersion to assist in managing microclimate of the patient skin, patient repositioning, early mobility, and the prevention of pulmonary complications.

The InTouch and Isolibrium system is for use by patients in an acute care setting. The acute care settings may include critical care, step down, progressive care, medical / surgical, sub-acute care, and post anesthesia care unit (PACU), or other locations as prescribed. The patient, accessories, and any extra loading must not exceed the safe working load of InTouch or Isolibrium.

The operators for the system are healthcare professionals (nurses, nurse aids, and doctors) who can use all system operations (for example: bed motion functions, nurse call, siderail communications, bed exit, or therapy options). Patients and bystanders can use the bed motion functions, nurse call, and siderail communications but are restricted from the use of the powered support surface functions. Trained professionals install, service, and calibrate the InTouch and Isolibrium system.

Expected service life

Isolibrium support surface has a five year expected service life under normal use, conditions, and with appropriate

periodic maintenance.

Isolibrium covers (top and bottom) have a two year expected service life under normal use, and conditions.

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Introduction

Contraindications

Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.

The InTouch and Isolibrium system is not intended:

• for use with patients 35 inches or less in height

• for use with patients that weigh less than 50 pounds

• for use with a full oxygen tent

• to support more than one individual at a time

• for use with a patient less than two years old

• in a home healthcare environment

• as a sterile product

• for use in the presence of flammable anesthetic mixture with air rich in oxygen or nitrous oxide Note: When Isolibrium is on the InTouch bed, a half-oxygen tent within the sidreails is allowable. Do not enclose

any part of the support surface foot box with the half-oxygen tent.

Isolibrium is not intended for use on patients with the following:

• unstable fractures

• unstable spinal cord injuries

Isolibrium Lateral Rotation and Turn Assist features are for use only after you complete a clinical assessment. This is to make sure that no adverse reaction would result in patients with the following:

English

• spinal cord injury

• skeletal traction

• significant hemoptysis

• bleeding disorders

• rib fractures

• for whom the techniques cause increased dyspnea or wheezing

• hemodynamic instable

• increased intracranial pressure

• skeletal traction

Specifications

Model 2971/2972 Isolibrium

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

Therapeutic weight 50 lb to 350 lb 22.7 kg to 158.7 kg

460 lb 208.6 kg

Safe working load Isolibrium (Sum of the patient and accessory weight)

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Introduction

86 °F (30 °C)

50 °F

(10 °C)

140 °F (60 °C)

-40 °F

(-40 °C)

75%

30%

95%

10%

1060 hPa

700 hPa

1060 hPa

500 hPa

English

Specifications (Continued)

Electrical requirements

Power cord

Low Air Loss flow rate Leakage current 300 uA Maximum

Noise level 50 dBA maximum

Stryker reserves the right to change specifications without notice.

Environmental conditions

Ambient temperature

Relative humidity (non-condensing)

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 CAN/CSA-C22.2 No. 60601-1 (2008)

3 foot, 16 AWG cord with hospital grade plug for use with the InTouch foot end auxiliary power outlet

100 LPM

Operation Storage and transportation

120VAC 50/60Hz, 2.5A

Atmospheric pressure

See the InTouch manual for bed specifications.

Contact information

Contact Stryker Customer Service or Technical Support at: 1-800-327-0770. Stryker Medical

3800 E. Centre Avenue Portage, MI 49002 USA

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.

Serial number location

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 (see Cover replacement, top on page 1-20).

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Introduction

Serial number location (Continued)

English

Date of manufacture

The year of manufacture is the first four digits of the serial number.

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Introduction

English

Product illustration

A Head end F Integration cable

B Foot end C

E Power cord K Retainer straps (D-rings not shown)

Note: To view the power cord label, the operator must position the cord by rotating it until the label is legible from a distance of up to 1m.

D-rings H

CPR straps

Isolibrium features

Physical Concepts Pressure Redistribution The ability of a support surface to distribute load over the

contact areas of the human body.

Pressure Redistribution setpoint Allows the operator to input patient weight range resulting

in automatic change of zoned sensor technology allowing immersion and envelopment.

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Handles Top support surface cover

Bottom support surface cover

Introduction

Isolibrium features (Continued)

Lateral Rotation Therapy

BackSmart® Turn Assist A feature of a support surface that provides a single

Max Inflate Allows maximum firmness inflation for use when boosting

Moisture management

Low Air Loss (LAL)

HeelGel™

Patient Specific Immersion™ Assists in managing microclimate of the patient skin,

Intelli-Gel® hollow column configuration licensed by EdiZONE LLC of Alpine, UT

Technology A feature of the support surface to address pressure

A feature of a support surface that provides rotation about a longitudinal axis as characterized by degree of patient turn, duration, and frequency.

position turn about a longitudinal axis.

a patient and on lateral transfer, Promotes patient ease with dangling, egress, and ingress.

The top surface cover draws excess moisture away from the patients skin and support surface interface.

Provides air flow to assist in the management of

(microclimate) the skin.

redistribution in the heel area.

patient repositioning, early mobility, and prevention of pulmonary complications.

English

www.stryker.com 2971-209-001 REV C 1-9

Installation

English

The product must reach the ambient operating temperature before installation or operation to avoid the risk of permanent damage to this product. Upon initial installation, reset the CPR.

WARNING

• Risk of Shock. This product must only be connected to a supply mains with protective earth. Grounding reliability can be achieved only when a hospital grade receptacle is used.

• Do not move the support surface without assistance.

• Do not operate the support surface without the Isolibrium top and bottom covers and linens.

• Always position the support surface on the InTouch bed frame to that the support surface does not contact the headboard.

• Do not use when gaps between the support surface and the bed frame are present to prevent the risk of entrapment. Only use the Isolibrium support surface with InTouch bed frames.

• Do not use fitted sheets with this support surface.

• Always confirm proper functionality of the scale system after you install the support surface to prevent product malfunction.

• Do not use extension cords with Isolibrium. It is only intended to be powered by InTouch with the power cord supplied.

• Always use the power source provided by the InTouch foot end auxiliary power outlet with Isolibrium.

Note: Do not plug into the power source until the assembly is complete.

Prerequisite: Minimum of two operators are required to install the support surface.

1. Put the InTouch bed into the flat position before installing the support surface.

2. If powered, unplug the InTouch from the wall outlet and turn the battery switch to off.

3. Remove the InTouch headboard and footboard from the bed.

4. Position an operator at each end of the support surface and lift onto the InTouch bed frame.

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Installation

5. Thread the retainer straps (A), down through the InTouch Fowler retainer holes (B) (Figure 1-1 on page 1-11).

English

Figure 1-1: Insert retainer straps

Note: The reverse side of the support surface is shown for reference. Make sure that the support surface is

installed with the top cover facing up.

6. Put the retainer strap through both D-Rings (C), both sides.

7. Thread the retainer strap through the bottom D-Ring, both sides.

8. Pull the retainer strap until the loop around the Fowler is tight, both sides.

9. Insert the loose end of the retainer straps behind the Fowler.

10. Reinstall the InTouch headboard and footboard.

11. Position the support surface against the footboard. Allow a small air gap at the headboard.

12. Connect the integration cable from the support surface foot end to the InTouch cable adapter (B) (Figure 1-2 on

13. Turn the locking collars clockwise to secure the connection.

14. Place the linens on the support surface as loose as possible to avoid creating a hammocking effect and increasing

page 1-12).

interface pressures.

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Installation

A B

English

15. Plug the power cord for the support surface into the InTouch foot end auxiliary power outlet (A) (Figure 1-2 on

page 1-12).

Figure 1-2: InTouch foot end auxiliary power outlet and mattress connector

16. Make sure that the power cord is routed to the side of the bed and not out the foot end of the InTouch.

17. Plug in the InTouch power cord into a properly grounded hospital grade three-prong power outlet.

18. Calibrate the bed following the procedures in the InTouch maintenance manual.

Notes

• Isolibrium is only operational when the power cord for the InTouch bed is in a 120v wall outlet.

• When the support surface is plugged into the InTouch bed, the InTouch footboard will respond. See the InTouch manual for more information.

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Operation

Applying the linens

WARNING

• Always make sure that the operator has access to the CPR straps.

• Do not use fitted sheets with this support surface.

To apply the linens:

1. Apply the linens using the “D” rings for the flat sheet.

2. Thread the four linen corners through the “D” rings (C) attached to the bottom cover to secure the linens (A) to the

support surface (B).

English

Figure 1-3: Apply linens

Note: Do not pull the linens tight. Keep the linens loose and as smooth as possible on top of the support surface to

effectively use the Turn Assist and Lateral Rotation functions.

Positioning a patient on the support surface

WARNING

• Always make sure that the tubing and wiring that is connected to the patient is long enough, stable, and secure during Lateral Rotation or Turn Assist.

• Always raise all of the InTouch bed siderails before starting Turn Assist or Lateral Rotation functions.

• Do not exceed the safe working load of the Isolibrium support surface. Excess weight could cause unpredictable safety and performance of this system.

• Always use extra caution when reading radiology images taken of a patient on a support surface because internal components can cause artifacts and distort readings.

CAUTION

• Do not allow sharp objects to come into contact with the support surface that could puncture, tear, or cut the cover.

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Operation

English

Positioning a patient on the support surface (Continued)

To position the patient:

1. Max Inflate the support surface.

2. Position the patient in the center of the support surface, align the patient’s head toward the head board (Figure 1-

4 on page 1-14).

3. Check the patient frequently during Lateral Rotation for proper positioning and support surface inflation (Figure 1-

5 on page 1-14 and Figure 1-6 on page 1-14).

Figure 1-4: Center the patient

Figure 1-5: Correct patient positioning

Figure 1-6: Incorrect patient positioning

Managing incontinence and drainage

WARNING

Always monitor the patient condition at regular intervals for patient safety.

You can use disposable diapers or incontinence pads to manage incontinence. Always provide appropriate skin care after each incontinence episode.

Activating and resetting CPR

When you activate for CPR, the system deflates and the InTouch control display will change.

WARNING

Always make sure that the operator has access to the CPR straps.

To activate for CPR, pull the red CPR strap straight out from the support surface (Figure 1-7 on page 1-15). The CPR straps are located on the left and right side of the foot end of the support surface. You can activate either one or both CPR straps.

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+ 50 hidden pages

Stryker Isolibrium 2971, Isolibrium 2972 Operation Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Operations Manual

Warning/Caution/Note Definition

Introduction

Installation

Operation