AIR+ Pump for SPR Plus Air Support Mattress Operations Manual Sept 2019

Symbols Refer to instruction manual/booklet Operating instructions/Consult instructions for use

General warning

Caution Cardiopulmonary resuscitation (CPR) Catalogue number



Serial number Manufacturer Mass of product 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. 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. 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 provisions for protective earthing or reliance upon installation conditions. Type B applied part – S P R P l u s ® 2790-100-000 and I s o F l e x L A L ® Support Surface 2860 Fuse

E347196 MEDICAL ELECTRICAL EQUIPMENT

IP21

Medical Equipment Classified by Underwriters Laboratories Inc. With Respect to Electric Shock, Fire, and Mechanical Hazards Only in Accordance with ANSI/AAMI ES60601-1:2012 and CAN/ CSA-C22.2 No. 60601-1:14.

Solids: Protection from touch by fingers and objects greater than 12 mm Liquids: Protection from the fall of vertical water drops

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For US Patents see www.stryker.com/patents

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Keep dry

6

Do not stack more than 6 high

This side up

Fragile Do not use sharp objects to open the package

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2863-009-001 Rev B.2

Table of Contents Warning/Caution/Note Definition ...2 Summary of safety precautions ...2 Introduction ...3 Product description ...3 Intended use...3 Expected service life...3 Contraindications ...3 Specifications ...4 Environmental conditions ...4 Product illustration...5 Button and icon descriptions ...5 Features...6 Contact information ...6 Serial number ...7 Date of manufacture ...7 Setup ...8 Connecting the power cord ...8 Connecting the hose...8 Operation ...9 Powering ON the pump...9 Increasing or decreasing pressure for SPR Plus ...9 Activating CPR release...9 Turn the lock ON or OFF...9 Powering OFF the pump ...10 Troubleshooting...11 Preventive maintenance ...12 Product alarms ...13 Cleaning and disinfecting with wipes ...14 Cleaning ...15 Disinfecting ...16 EMC information ...17

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Warning/Caution/Note Definition The words W A R N I N G , C A U T I O N , and N O T E 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. N o t e - Provides special information to make maintenance easier or important instructions clearer.

Summary of safety precautions Always read and strictly follow the warnings and cautions listed on this page. Service only by qualified personnel. WARNING • Consult the operations manual for the support surface before you attach the pump. • Always connect this product to a hospital grade receptacle. Failure to provide proper grounding could result in electrical shock. • Never plug the power cord for this product into an extension cord. • Do not expose this product to liquids while powered as this could result in a severe electrical hazard. • Do not modify or change this device. Service should only be completed by qualified personnel. Failure could result in injury and void your warranty. • Always unplug the product before you begin cleaning or disinfecting. • Do not immerse the product in cleaning or disinfectant solutions. • Do not spray or allow liquids to enter the power cord ports or the hose ports. • Always make sure that you wipe each product with clean water and dry each product after you clean. Some cleaning agents are corrosive in nature and may cause damage to the product. Failure to follow the cleaning and disinfecting instructions may void your warranty. • 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. • Portable RF communications equipment, including peripherals such as antenna cables and external antennas, should be no closer than 12 inches (30 cm) to any part of A I R + , including cables specified by the manufacturer. • Avoid stacking or placing equipment adjacent with other equipment to prevent improper operation of the products. If such use is necessary, carefully observe stacked or adjacent equipment to make sure that they are operating properly. 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. • Always allow the product to come to room temperature after exposure to extreme high or low temperatures. • Always check the power cord for cuts, exposed wires, worn insulation, or other damage that could result in electrical hazards. • Do not over expose the product to higher concentration chemical solutions as these may degrade the product. • Failure to follow manufacturing instructions may also affect useful life of the product.

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Introduction 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. • 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. Note • 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 The Stryker Model 2863 A I R + ™ Pump is an electric pump for use with Model 2860 I s o F l e x L A L ® support surface or Model 2790-100-000 S P R P l u s ® overlay. This pump provides Low Air Loss (LAL) for I s o F l e x L A L support surface and continuous air to the S P R P l u s overlay. LAL provides air flow to help manage microclimate of the skin. The hooks on the back of this product allows you to attach the pump to the footboard of the compatible bed frames.

Intended use The A I R + pump when used with the I s o F l e x L A L support surface or the S P R P l u s overlay assists in the prevention and treatment of pressure injuries or pressure ulcers (all stages, Unstageable injury, and Deep tissue injury). We recommend you implement this product in combination with clinical evaluation of risk factors and skin assessments made by a healthcare professional. This pump is for use in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this pump include healthcare professionals (such as caregivers, nurses, physicians, patient transporters, and other healthcare providers). This product is not intended to be sterile, does not include a measuring function, and is not for use in a home healthcare environment.

Expected service life The A I R + pump has a 5 year expected service life under normal use, conditions, and with appropriate periodic maintenance.

Contraindications A I R + pump when used with S P R P l u s overlay, air support therapy is not recommended when spinal stability is a concern.

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Specifications Height

17.25 in.

43.8 cm

Width

9.25 in.

23.5 cm

Depth

7.25 in.

18.4 cm

Weight

13.2 lb

6.0 kg

Interface control panel

LED

Input voltage

120 V

Electric current

0.6 A

Input frequency

60 Hz

Peak noise level

<50 dba

Mode of operation

Continuous

Power cord

Short

3.2 ft

1m

Long

16.4 ft

5m

Compliance

IEC 60601-1 3.1 Edition; RoHS Directive 2002/95/EC Reach; IEC 60601-1-8:2012, IEC 60601-1-2:2014; CAN/ CSA C22.2 No. 601.1

Compatible with bed frame

3002 S3™, 3005 S3™, InTouch®, Spirit Select™

Environmental conditions Environmental conditions

Operation

Storage and transportation

Ambient temperature

Relative humidity (non-condensing)

Atmospheric pressure

Stryker reserves the right to change specifications without notice.

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Product illustration

A

I

B C H

D J E B F G

A

User interface

F

Power inlet

B

Bumpers

G

Anti-vibration foot

C

Transport handle

H

Hose port

D

Hooks

I

Back pump housing

E

HEPA filter

J

Front pump housing

Button and icon descriptions Icon

Name

Description

Power button on, green

Press once to power ON

Power button off

Press and hold 2 seconds to power OFF

Lock off icon

Lock is off and allows you to change settings

Lock on icon

Lock on locks the screen and does not allow you to change settings

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Icon

18, 21, 24, 27, 30

Name

Description

Decrease or increase firmness buttons

Press down to decrease or press up to increase firmness for S P R Plus

Firmness level icons

5 levels to set firmness in mmHg. Icons are green when active.

Pressure alarm on icon

Pressure alarm on when pressure is too low or too high

Pressure alarm off icon

Pressure alarm off

S P R P l u s button

Activates S P R P l u s and allows selection of the firmness levels when selected

I s o F l e x L A L button

Activates Low Air Loss for I s o F l e x when selected

SPR PLUS IsoFlex LAL

SPR PLUS IsoFlex LAL

Features Low Air Loss (LAL)

Provides air flow to help manage microclimate of the skin.

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.

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Serial number

A

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

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Setup Unpack the cartons and check all items. Make sure that the product operates before you place into service. WARNING • Consult the operations manual for the support surface before you attach the pump. • Always connect this product to a hospital grade receptacle. Failure to provide proper grounding could result in electrical shock. • Never plug the power cord for this product into an extension cord. • Do not expose this product to liquids while powered as this could result in a severe electrical hazard. CAUTION • Always allow the product to come to room temperature after exposure to extreme high or low temperatures. • Always check the power cord for cuts, exposed wires, worn insulation, or other damage that could result in electrical hazards. 1. Bring the product to room temperature. 2. Place the pump in a secure location. Allow space around the pump to connect and disconnect the hoses and power cord. Optional placements: a. Option 1: Hang the pump on a compatible bed. Make sure that the pump is secure. b. Option 2: Place the pump on the floor. Make sure that the pump is away from foot traffic to avoid the risk of a trip hazard.

Connecting the power cord 1. Attach the power cord to the pump. 2. Plug the power cord into an accessible receptacle.

Connecting the hose 1. Attach the hose to the pump hose port. 2. Attach the hose to the support surface hose port.

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Operation Powering ON the pump 1. See Setup (page 8) to prepare the pump for operation. 2. Press the power button once to turn on the product. (Figure 1).

30

SPR PLUS

27 24

IsoFlex LAL

21 18 mmHg

Figure 1 – Status view, operator view N o t e - The pump will power ON with either S P R P l u s or I s o F l e x L A L based on last use.

Increasing or decreasing pressure for SPR Plus You can increase or decrease the pressure by 3 mmHg increments when the S P R P l u s mode is selected. To increase pressure, press the up arrow.

30

SPR PLUS

27 24

IsoFlex LAL

21 18 mmHg

Figure 2 – Increase or decrease To decrease pressure, press the down arrow.

Activating CPR release Unscrew the hose from the S P R P l u s overlay to deflate the support surface for CPR. N o t e - You do not need to remove the hose from I s o F l e x L A L support surface to perform CPR.

Turn the lock ON or OFF To turn the ON or OFF. 1. Press and hold the lock button for 1 second to turn ON the lock.

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30

SPR PLUS

27 24

IsoFlex LAL

21 18 mmHg

Figure 3 – Lock ON N o t e - Lock ON locks the screen and does not allow you to change settings. 2. Press and hold the lock button for 2 seconds to turn OFF the lock.

30

SPR PLUS

27 24

IsoFlex LAL

21 18 mmHg

Figure 4 – Lock OFF

Powering OFF the pump Press the power button and hold for 2 seconds to power OFF the pump.

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Troubleshooting Problem

Screen

Power loss, product does not turn ON 30

SPR PLUS

27 24

IsoFlex LAL

Cause

Recommended action

Power cord not seated, power cord unplugged from outlet, or possible internal damage

Make sure that the power cord is plugged into the product and the outlet.

Lock is ON

Press and hold the lock button for 2 seconds to turn lock OFF.

Pressure alert

Check air hose for kink.

21 18 mmHg

Button not responsive 30

SPR PLUS

27 24 21

IsoFlex LAL

18 mmHg

Alarm icon is ON 30

SPR PLUS

27 24

IsoFlex LAL

Check the hose for connection.

21 18 mmHg

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If not resolved, call service.

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Preventive maintenance W A R N I N G - Do not modify or change this device. Service should only be completed by qualified personnel. Failure could result in injury and void your warranty. Note • At a minimum, check all items listed during annual preventive maintenance for all Stryker Medical products. You may need to perform preventive maintenance checks more often based on your level of product usage. • Remove product from service before you perform preventive maintenance. • Consult your local regulations to dispose of electronic equipment. Inspect the following items: All fasteners are secure Pump housing or components (hose, power cords, or case) for cracks, holes, or damaged Hooks that hang the pump on the bed frame are not damaged Check for secure hose connections User interface is not cracked or damaged HEPA filter (replace each year) Product serial number: Completed by: Date:

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Product alarms The product alarm for this product is display only, no audible alarms. Icon

Priority alarm

Name

Delay

Therapy interrupted

Low

Pressure alarm

15 minutes

Yes

Note • Alarm displays on the interface control panel of the pump. • Alarm resets if there is power loss to the pump.

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Cleaning and disinfecting with wipes For United States only. Confirm availability for your configuration or region. Call Stryker Customer Service: 1-800-3270770. Stryker’s preferred wipes (2060-000-001 6'' x 10'' or 2060-000-002 9'' x 12'') include the following active ingredients: •

n-Alkyl (60% C14, 30% C16, 5% C12, 5% C18) dimethyl benzyl ammonium chloride - 0.154%

•

n-Alkyl (68% C12, 32% C14) dimethyl ethylbenzyl ammonium chloride - 0.154%

•

Isopropanol - 21.000%

Non-active ingredient: Ethylene Glycol Monobutyl Ether – < 3% N o t e - For safety information, read the product label. To clean or disinfect the external product surface: 1. To clean, wipe external surfaces with a fresh, clean wipe to remove all visible soils. Repeat as necessary until the product is clean. Note • Use as many wipes as necessary. • Complete step 1 before you disinfect. 2. To disinfect, wipe external surfaces with a fresh, clean wipe until wet. Allow the external surface to remain wet for two minutes at room temperature. 3. Allow the product to dry before you return it to service.

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Cleaning WARNING • Always unplug the product before you clean or disinfect. • Do not immerse the product in cleaning or disinfectant solutions. • Do not spray or allow liquids to enter the power cord ports or the hose ports. • Always make sure that you wipe each product with clean water and dry each product after you clean. Some cleaning agents are corrosive in nature and may cause damage to the product. Failure to follow the cleaning and disinfecting instructions may void your warranty. CAUTION • Do not over expose the product to higher concentration chemical solutions as these may degrade the product. • Failure to follow manufacturing instructions may also affect useful life of the product. Recommended cleaning agents include: •

A clean damp cloth and mild soapy water

To clean the external side of the pump: 1. Unplug the controller. 2. Wipe the outside of the product with a clean, soft cloth moistened with a mild soap and water solution to remove foreign material. 3. Follow specified contact time in accordance with the manufacturer’s instructions for use. 4. Using a clean, soft cloth, wipe the outside of the product with water. 5. Dry the external surface with a clean, dry cloth.

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Disinfecting WARNING • Always unplug the product before you clean or disinfect. • Do not immerse the product in cleaning or disinfectant solutions. • Do not spray or allow liquids to enter the power cord ports or the hose ports. • Always make sure that you wipe each product with clean water and dry each product after you clean. Some cleaning agents are corrosive in nature and may cause damage to the product. Failure to follow the cleaning and disinfecting instructions may void your warranty. CAUTION • Do not over expose the product to higher concentration chemical solutions as these may degrade the product. • Failure to follow manufacturing instructions may also affect useful life of the product. Recommended chemical solutions: •

Quaternaries (active ingredient - ammonium chloride) that contain less than 3% glycol ether

•

Phenolic solution (Matar)

•

Chlorinated bleach solution (6500 ppm)

•

Accelerated hydrogen peroxide

•

Potassium peroxymonosulfate

•

70% isopropyl alcohol

Follow hospital protocol for support surface care between patients to avoid the risk of cross-contamination and infection. N o t e - Make sure that you unplug the product before you clean or disinfect.

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EMC information W A R N I N G - 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. Note • The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. • This equipment is suitable for use in hospitals except for near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Guidance and manufacturer’s declaration - electromagnetic emissions The 2863 S P R + pump is intended for use in the electromagnetic environment specified below. The customer or the user of the 2863 S P R + pump should assure that it is used in such an environment. Compliance

Electromagnetic environment

Group 1

The 2863 A I R + pump uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class A

The 2863 A I R + pump is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Harmonic Emissions IEC 61000-3-2

Class A

Voltage Fluctuations Flicker Emissions IEC 61000-3-3

Complies

Emissions test

RF Emissions CISPR 11

WARNING • Portable RF communications equipment, including peripherals such as antenna cables and external antennas, should be no closer than 12 inches (30 cm) to any part of A I R + , including cables specified by the manufacturer. • Avoid stacking or placing equipment adjacent with other equipment to prevent improper operation of the products. If such use is necessary, carefully observe stacked or adjacent equipment to make sure that they are operating properly. Recommended separation distances between portable and mobile RF communication equipment and the 2863 AIR+ pump The 2863 A I R + pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 2863 A I R + pump can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 2863 A I R + pump as recommended below, according to the maximum output power of the communications equipment.

Band (MHz)

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Maximum Power

Minimum Separation Distance

(W)

(m)

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