Stryker 0940-000-000 User manual

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Instructions For Use

0940-001-025 L

2016-10 0940-001-025 Rev-L www.stryker.com

Cast Cutter

0940-000-000

0941-000-000

Instructions For Use

ENGLISH (EN)

2 www.stryker.com

EN 0940-001-025 Rev-L

Introduction

This Instructions For Use manual is the most comprehensive source of

information for the safe and effective use of your product. This manual may

be used by in-service trainers, physicians, nurses, surgical technologists,

biomedical equipment technicians, and central supply/sterile processing

technicians. Keep and consult this reference manual during the life of the

product.

The following conventions are used in this manual:

▪ A WARNING highlights a safety-related issue. ALWAYS comply with this

information to prevent patient and/or healthcare staff injury.

▪ A CAUTION highlights a product reliability issue. ALWAYS comply with this

information to prevent product damage.

▪ A NOTE supplements and/or clarifies procedural information.

For additional information, especially safety information, or in-service training,

contact your Stryker sales representative or call Stryker customer service.

Outside the US, contact your nearest Stryker subsidiary.

Indications For Use

The Stryker Cast Cutter is intended to section and remove synthetic and

plaster casts.

Contraindications

None known.

For Use With

This section describes system components that must be used with the

equipment described in this manual to create a safe and effective system.

DESCRIPTION REF

Cast Cutter Blades 0940-XXX-XXX series

WARNING: ALWAYS select and install a blade that is appropriate for

the cast material to be cut.

CAST MATERIAL BLADE TYPE BLADE REF

Plaster or Synthetic Ion Nitrided 0940-023-000

Plaster Stainless Steel 0940-025-000

Synthetic Titanium Nitrided 0940-035-000

User/Patient Safety

WARNINGS:

▪ Before using any system component, or any component compatible with

this system, read and understand the instructions. Pay particular attention

to WARNING information. Become familiar with the system components

prior to use.

▪ Only trained and experienced healthcare professionals should use this

equipment.

▪ The healthcare professional performing any procedure is responsible

for determining the appropriateness of this equipment and the specific

technique used for each patient. Stryker, as a manufacturer, does not

recommend surgical procedure or technique.

▪ Upon initial receipt and before each use, operate the equipment and

inspect each component for damage. DO NOT use any equipment if

damage is apparent or the inspection criteria are not met. See the

Inspection, Testing, and Maintenance section.

▪ Only individuals trained and experienced in the maintenance of reusable

medical devices should install, inspect, service, and test this equipment as

described in this manual.

▪ DO NOT modify any system component or accessory, including the power

cord and power cord plug.

▪ ALWAYS position the equipment so that the power cord plug may be easily

disconnected from the power supply.

▪ DO NOT use this equipment in areas in which flammable anesthetics or

flammable agents are mixed with air, oxygen or nitrous oxide.

▪ Take special precautions regarding electromagnetic compatibility (EMC)

when using medical electrical equipment like this system. Install and

place this system into service according to the EMC information contained

in this manual. Portable and mobile RF communications equipment can

affect the function of this system.

0940-001-025 Rev-L EN

www.stryker.com 3

Accessories

WARNINGS:

▪ Use only Stryker-approved system components and accessories, unless

otherwise specified. Failure to comply may result in fire, electric shock,

or injury.

▪ Using other electronic components and accessories may result in

increased electromagnetic emissions or decreased electromagnetic

immunity of the system.

NOTE: For a complete list of accessories, contact your Stryker sales

representative or call Stryker customer service. Outside the US, contact your

nearest Stryker subsidiary.

This section describes system components that may be ordered to replace

original equipment that is damaged, worn, or must be replaced. This section

may also contain optional components used with the system.

The following Stryker-approved accessories are sold separately:

DESCRIPTION REF

Small Cast Spreader 0082-000-000

Large Cast Spreader 0083-000-000

Cast Cutter Blades 0940-XXX-XXX series

Blade Tool 0940-050-000

Vacuum Line Cap 0940-001-135

CastVac™ 0986-000-000

0987-000-000

0996-000-000

Adaptor Hose with Cord (to connect Cast

Cutter REF 0940-000-000 to Stryker

PlasterVac™ REF 0886-000-000)

0940-886-000

Adaptor Hose with Cord (to connect Cast

Cutter REF 0940-000-000 to Stryker

PlasterVac REF 0846-000-000 or

0856-000-000)

0940-855-000

Adaptor Hose with Cord (to connect Cast

Cutter REF 0940-000-000 to Stryker

OrthoVac™ REF 0864-000-000)

0940-864-000

Cast Cutter Repair Kit 0940-001-140Q

WARNING: When using a Stryker CastVac, ALWAYS connect the Cast

Cutter to a CastVac with an appropriate voltage. Failure to comply may

result in fire, electric shock, or injury.

CAST CUTTER REF VOLTAGE CASTVAC REF

0940-000-000 100-120 V 0986-000-000

0987-000-000

0941-000-000 220-240 V 0996-000-000

Definitions

The symbols located on the equipment and/or labeling are defined in this

section or in the Symbol Definition Chart. See the Symbol Definition Chart

supplied with the equipment.

SYMBOL DEFINITION

High Speed Mode

Standby Mode

Standard Speed Mode

Class II equipment (Double Insulation)

Type BF Applied Part

Alternating current (AC)

Non-ionizing electromagnetic radiation

General warning sign

Refer to instruction manual/booklet

Consult instructions for use

This symbol is intended to alert service personnel of the

presence of voltage that may cause injury or fatal electric

shock. Disconnect the device from the electrical supply

before servicing.

4 www.stryker.com

EN 0940-001-025 Rev-L

Features

Cast Cutter

AVacuum Line Cap

BPower Cord

CBrush Cap

DFunction Switch

EBlade Tool

FBlade

GBlade Retention Screw

HBlade Guide Posts (4)

IVacuum Hood

Model REF 0940-000-000 Only:

JPower Cord Plug

Model REF 0941-000-000 Only:

KPower Source Cord Plug

LPower Source Cord

MAppliance Inlet Connector Plug

NAppliance Inlet Connector

Function Switch

High Speed Mode – The Cast Cutter blade will oscillate

at high speed.

Standby Mode – The Cast Cutter blade will not

oscillate.

NOTE: When the Cast Cutter is not in use, set the

function switch to the standby mode position.

Standard Speed Mode – The Cast Cutter blade will

oscillate at standard speed.

0940-001-025 Rev-L EN

www.stryker.com 5

Instructions

To Install a Blade

WARNINGS:

▪ ALWAYS disconnect the power cord plug from the facility power outlet

or CastVac power outlet before installing a blade. Failure to comply may

cause fire, electric shock, or injury.

▪ Before each use, inspect the blade for wear. DO NOT use a dull blade.

Using a dull blade may cause a burn injury.

CAUTIONS:

▪ To ensure safe and efficient cutting and avoid damaging the equipment,

ALWAYS install the blade as indicated in these instructions.

▪ The blade retention screw is captive and cannot be removed from the

Cast Cutter. DO NOT attempt to remove the screw or loosen the screw

beyond the point when it no longer turns.

1. Use the blade tool supplied with the Cast Cutter to loosen the blade

retention screw. Turn the screw counterclockwise until it no longer turns.

2. Slide a blade over the screw and the top two blade guide posts.

3. Pull the blade down behind the screw and over the bottom two blade

guide posts. Make sure that all four posts are engaged with the blade.

4. Use the blade tool to tighten the blade retention screw against the blade.

WARNING: Before operating the equipment, ALWAYS make sure the

blade is securely installed and the blade retention screw is tight. An

improperly tightened screw may come loose and cause the blade to

fracture.

5. Confirm that the blade is securely installed and the blade retention screw

is tight against the blade.

To Connect the Cast Cutter to a Power Source

WARNING: ALWAYS set the function switch to the standby mode

position before connecting the Cast Cutter to a facility power outlet or

CastVac power outlet.

CAUTION: ALWAYS place the power cord where it will not be stepped on,

tripped over, or otherwise subjected to damage or stress.

NOTE: The Cast Cutter may be connected to a facility power outlet or a

CastVac with an appropriate voltage rating. For more information, see the

Accessories section and the instructions for use supplied with the CastVac.

1. Set the function switch to the standby mode.

2. Connect the power cord plug to a facility power outlet or CastVac power

outlet.

NOTE: To connect Cast Cutter REF 0941-000-000 to a facility power outlet,

first connect the appliance inlet connector plug to the appliance inlet

connector. See the Features section.

To Operate the Cast Cutter

WARNINGS:

▪ ALWAYS follow the recommended duty cycle to prevent the equipment

from overheating. See the Specifications section.

▪ ALWAYS operate the equipment within the specified environmental

condition values. See the Specifications section.

▪ DO NOT use this equipment in the presence of fluids.

▪ ALWAYS set the function switch to the standby mode position before

passing the Cast Cutter to another person.

▪ DO NOT apply excessive pressure, such as bending or prying, with the

blade. Excessive pressure may cause the blade to fracture. If prying on

the cast is required, use a cast spreader tool.

6 www.stryker.com

EN 0940-001-025 Rev-L

▪ ALWAYS use extreme caution when cutting synthetic cast material. The

blade may overheat and cause a burn injury.

▪ DO NOT remove a non-padded cast with the Cast Cutter. Skin may

adhere to the cast material and result in a cut or burn injury.

▪ DO NOT operate this equipment with a damaged power cord or power

cord plug.

▪ DO NOT use Stainless Steel Cast Cutter Blade REF 0940-025-000 to cut

synthetic cast material.

1. Set the function switch to the desired speed mode. The blade will begin

to oscillate.

WARNING: To reduce the spray of cast debris, ALWAYS align the Cast

Cutter blade in a vertical orientation, perpendicular to the cast when

cutting.

2. Grasp the Cast Cutter as shown, and align the blade in a vertical

orientation, perpendicular to the cast.

3. Gently push the oscillating blade through the cast material.

NOTES:

▪ Cutting action is achieved by high speed oscillation of the blade. The

blade cuts on both the backward and forward strokes of the excursion. To

engage more blade teeth and allow for more efficient cutting, the blade

should be moved slightly up and down as the cut progresses.

▪ You should feel resistance as the blade cuts through the cast material.

When the blade fully penetrates the cast, this resistance ends, and you

should withdraw the blade.

▪ Use your index finger as a depth gauge to control the blade as it reaches

the padding beneath the cast.

WARNING: DO NOT use a continuous, linear motion to cut the cast.

Continuous contact of the blade against the skin or cast padding may

cause a cut or burn injury.

4. Withdraw and advance the blade in the direction of the cut.

5. Repeat this motion of alternating pressure along the direction of the cut

until the cut is complete.

NOTE: Use a cast spreader to remove the cast, if necessary.

6. Upon completion, set the function switch to the standby mode.

To Disconnect the Cast Cutter from the Power

Source

WARNINGS:

▪ ALWAYS set the function switch to the standby mode position before

disconnecting the Cast Cutter from the facility power outlet or CastVac

power outlet.

▪ The function switch does not remove electrical power from the Cast

Cutter. To remove the electrical power, you must disconnect the power

cord plug from the facility power outlet or CastVac power outlet.

CAUTION: To reduce the risk of damage to the power cord, ALWAYS grasp the

power cord plug, not the power cord, when disconnecting the Cast Cutter.

1. Verify the function switch is in the standby mode.

2. Disconnect the power cord plug from the facility power outlet or CastVac

power outlet.

To Remove the Blade

WARNING: ALWAYS disconnect the power cord plug from the facility

power outlet or CastVac power outlet before removing the blade.

Failure to comply may cause fire, electric shock, or injury.

CAUTION: The blade retention screw is captive and cannot be removed from

the Cast Cutter. DO NOT attempt to remove the screw or loosen the screw

beyond the point when it no longer turns.

NOTE: It is not necessary to remove the blade after each use. Blade removal

is required when installing a blade that is appropriate for the cast material or

when replacing a worn blade.

1. Use the blade tool to loosen the blade retention screw. Turn the screw

counterclockwise until it no longer turns.

2. Pull the blade off of the bottom two blade guide posts.

3. Slide the blade up behind the screw and remove the blade.

4. Save or dispose of the blade as required.

0940-001-025 Rev-L EN

www.stryker.com 7

Cleaning

WARNINGS:

▪ ALWAYS disconnect the power cord plug from the facility power outlet or

CastVac power outlet before cleaning the equipment. Failure to comply

may cause fire, electric shock, or injury.

▪ Upon initial receipt and before each use, clean and disinfect the

equipment as indicated.

▪ DO NOT sterilize the equipment.

▪ DO NOT immerse or soak the equipment in liquid. DO NOT flush the

internal vacuum line with liquid. DO NOT allow moisture or liquid to soak

into electrical plugs, receptacles, or openings. Moisture or liquid inside the

equipment may create an unsafe electrical condition, cause corrosion,

and/or damage the electrical and/or mechanical components.

▪ Before each use, make sure the equipment is completely dry. DO NOT

use any equipment if moisture is present.

▪ DO NOT use solvents, lubricants, or other chemicals, unless otherwise

specified.

To Clean the Equipment

1. Disconnect the power cord plug from the facility power outlet or CastVac

power outlet.

2. If the vacuum hood is blocked with debris, perform the following steps:

2.1. Use a standard slotted screwdriver to remove the captive screw,

Belleville washer, and vacuum hood.

2.2. Remove any blockage and wipe away the debris.

2.3. Reinstall the vacuum hood and Belleville washer, and securely

tighten the captive screw.

NOTE: Make sure the Belleville washer is oriented correctly during

reassembly. See the illustration above.

3. Wipe the external surfaces of the equipment with a soft cloth moistened

with a non-abrasive, mild detergent and water.

4. Thoroughly dry the equipment with a soft, absorbent cloth.

To Disinfect the Equipment

1. Wipe the external surfaces of the equipment with a soft cloth moistened

with isopropyl alcohol. Blades can be disinfected with a standard

disinfectant.

2. Thoroughly dry the equipment with a soft, absorbent cloth.

Inspection, Testing, and Maintenance

WARNINGS:

▪ Only individuals trained and experienced in the maintenance of reusable

medical devices should inspect, test, and maintain this equipment.

▪ DO NOT disassemble or service this equipment, unless otherwise

specified. Failure to comply may cause fire, electric shock, or injury.

▪ ALWAYS disconnect the power cord plug from the facility power outlet or

CastVac power outlet before performing maintenance procedures on the

equipment. Failure to comply may cause fire, electric shock, or injury.

▪ Only the components listed in the Inspection, Testing, and Maintenance

section are serviceable.

▪ When servicing or maintaining this equipment, use only Stryker-approved,

identical replacement parts.

▪ DO NOT use the Cast Cutter if the leakage current exceeds the

appropriate specification. See the Specifications section.

NOTES:

▪ The Cast Cutter has a lifetime lubrication system. No additional lubrication

is required.

▪ Calibration adjustments for the Cast Cutter were made during

manufacturing. No additional calibration is required.

▪ Maintenance documentation for this equipment is available upon request

to Stryker-authorized service personnel only.

▪ For service, contact your Stryker sales representative or call Stryker

customer service. Outside the US, contact your nearest Stryker subsidiary.

INTERVAL ACTION INSPECTION CRITERIA

Upon initial

receipt and

before each

use.

Inspect the

equipment.

If damage or excessive wear is

apparent, contact Stryker for repair.

If any components are loose or

missing, contact Stryker for repair.

Inspect the

power cord

and/or power

source cord.

If cracks, cuts, or damage is apparent,

contact Stryker for repair.

Inspect the

blade.

If the blade is dull, replace the blade.

See the Instructions section.

Operate the

equipment.

If unusual sound, excessive noise, or

vibration is apparent, contact Stryker

for repair.

Annually. Actuate the

function switch

five times.

If the equipment does not operate

normally, contact Stryker for repair.

Use a

tachometer

to determine

the operating

speed.

If the equipment does not operate at

the proper speed, contact Stryker for

repair. For speed information, see the

Specifications section.

8 www.stryker.com

EN 0940-001-025 Rev-L

To Replace the Motor Brushes and Springs

WARNINGS:

▪ ALWAYS disconnect the power cord plug from the facility power outlet or

CastVac power outlet before performing maintenance procedures on the

equipment. Failure to comply may cause fire, electric shock, or injury.

▪ DO NOT insert a metal tool or object into the Cast Cutter. To remove the

spring and brush, turn the Cast Cutter upside down.

Required Parts

ITEM DESCRIPTION QUANTITY REF

ABrush 2 0940-001-113

BSpring 2 0038-049-000

CBrush Cap 2 0058-018-000

Required Tools

DESCRIPTION QUANTITY

Standard Slot Screwdriver 1

Torque Wrench 1

Leakage Current Measuring Device 1

1. Disconnect the power cord plug from the facility power outlet or CastVac

power outlet.

WARNING: When installed, the brush cap is under pressure from the

spring. Hold the brush cap to prevent the spring from ejecting the

brush cap upon removal.

2. Loosen and remove the brush cap, spring and brush.

3. Dispose of the used spring and brush.

CAUTION: To ensure proper contact, install the brush so that the concave

surface of the brush is oriented as shown.

4. Orient the concave surface of the brush as shown.

5. Insert the brush into the Cast Cutter.

6. Place the spring onto the brush.

CAUTION: During installation, DO NOT overtighten the brush cap.

7. Install and carefully tighten the brush cap to 0.45-0.90 N·m [4-8 lb·in].

8. Repeat the steps to replace the other motor brush and spring.

WARNING: ALWAYS test the leakage current after replacing the motor

brushes and springs.

9. Test the Cast Cutter to verify the leakage current is within the appropriate

specification. See the Product Safety Certification standards in the

Specifications section for leakage current test procedures and limits.

Storage and Handling

CAUTION: ALWAYS store the equipment within the specified environmental

condition values throughout its useful life. See the Specifications section.

To ensure the longevity, performance and safety of this equipment, use of the

original packaging material is recommended when storing or transporting this

equipment.

Disposal/Recycle

WARNING: 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.

To comply with European Community Waste Electrical and

Electronic Equipment (WEEE) Directive 2012/19/EU, this

device 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.

0940-001-025 Rev-L EN

www.stryker.com 9

Troubleshooting

WARNING: DO NOT disassemble or service this equipment, unless

otherwise specified.

NOTE: For service, contact your Stryker sales representative or call Stryker

customer service. Outside the US, contact your nearest Stryker subsidiary.

PROBLEM CAUSE SOLUTION

The Cast Cutter does

not operate.

The Cast Cutter is not

connected to facility

power.

See the To Connect the

Cast Cutter to a Power

Source section.

The motor brushes are

installed in the wrong

orientation.

Remove and install the

motor brushes. See the

Inspection, Testing, and

Maintenance section.

The function switch is

broken.

Return the Cast Cutter

to Stryker for repair.

The fuse is blown. Return the Cast Cutter

to Stryker for repair.

The Cast Cutter

operates at a very low

speed.

The motor brushes are

installed in the wrong

orientation.

Remove and install the

motor brushes. See the

Inspection, Testing, and

Maintenance section.

The Cast Cutter does

not operate smoothly,

or operates with

excessive noise.

The motor brushes are

worn.

Replace the motor

brushes and springs.

See the Inspection,

Testing, and

Maintenance section.

The roller bearing is

worn.

Return the Cast Cutter

to Stryker for repair.

The blade does not cut

smoothly.

The blade is worn. Replace the blade. See

the Instructions section.

The blade slips. The blade guide posts

are worn.

Return the Cast Cutter

to Stryker for repair.

When used with a

CastVac, the level of

suction is reduced.

The vacuum hood is

blocked with debris.

Remove the debris from

the vacuum hood. See

the Cleaning section.

The equipment

experiences sporadic

electrical interference.

Electrical noise is

present.

Turn off all electrical

equipment not in use.

Relocate electrical

equipment; increase

spatial distance

between devices.

Connect electrical

equipment to different

facility power outlets.

10 www.stryker.com

EN 0940-001-025 Rev-L

Specifications

Model: Stryker Cast Cutter (REF 0940-000-000) Stryker Cast Cutter (REF 0941-000-000)

Electrical: 100-120 V , 50-60 Hz, 1.5 A input 220-240 V , 50-60 Hz, 0.75 A input

Speed: 100 V Nominal 120 V Nominal 230 V , 50 Hz Nominal

High: 12,800 CPM (cycles per minute) 15,900 CPM 15,900 CPM

Standard: 7,700 CPM 10,700 CPM 10,700 CPM

Power Cord: 3.1 m [10.25 ft] length, fitted with NEMA 1-15P plug 3.1 m [10.25 ft] length

Power Source Cord: None 2.5 m [8.2 ft] length, fitted with CEE 7/7 Schucko plug

Dimensions: 25.4 cm [10 inch] length 25.4 cm [10 inch] length

7.6 cm [3 inch] height 7.6 cm [3 inch] height

Mass: 1.3 kg [2.8 lb] 1.3 kg [2.8 lb]

Excursion: 3.2 mm [0.125 inch] 3.2 mm [0.125 inch]

Mode of Operation: Continuous with Intermittent Loading Continuous with Intermittent Loading

Duty Cycle: 15 minutes on, 1 time 15 minutes on, 1 time

Rest Between Cycles: 20 minutes 20 minutes

Maximum Temperature of

Applied Part:

Less than 48 °C [118 °F] (Maximum surface temperature as tested

to the standards listed under Product Safety Certification.)

Less than 48 °C [118 °F] (Maximum surface temperature as tested

to the standards listed under Product Safety Certification.)

Equipment Type: Class II (Double Insulation) Class II (Double Insulation)

Type BF Applied Part Type BF Applied Part

Ingress Protection: IPX0 Ordinary Equipment IPX0 Ordinary Equipment

Means of Isolation from

Supply Mains:

Disconnection of the power cord plug from the facility power

outlet or CastVac power outlet

Disconnection of the power cord plug from the facility power

outlet or CastVac power outlet

Environmental Conditions: Operation Storage and Transportation Operation Storage and Transportation

Temperature Limitation:

Humidity Limitation:

Atmospheric Pressure

Limitation:

0940-001-025 Rev-L EN

www.stryker.com 11

Model: Stryker Cast Cutter (REF 0940-000-000) Stryker Cast Cutter (REF 0941-000-000)

European

Conformity: Not applicable

Product Safety

Certification: CSA International

Canadian Standards Association (CSA)

CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment

— Part 1: General Requirements for Safety

Underwriters Laboratories (UL)

UL 60601-1, Medical Electrical Equipment, Part 1: General

Requirements for Safety — First Edition; Revisions through and

including April 26, 2006

Canadian Standards Association (CSA)

CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment

— Part 1: General Requirements for Safety

Underwriters Laboratories (UL)

UL 60601-1, Medical Electrical Equipment, Part 1: General

Requirements for Safety — First Edition; Revisions through and

including April 26, 2006

International Electrotechnical Commission (IEC)

IEC 60601-1:1988, Medical Electrical Equipment — Part 1:

General Requirements for Safety - Second Edition; Amendment

1 (1991); Amendment 2 (1995); Corrigendum 1 (1995)

European Committee for Electrotechnical Standardization

(CENELEC)

EN 60601-1:1990, Medical Electrical Equipment — Part 1:

General Requirements for Safety; Amendment 1 (1993);

Amendment 11 (1993); Amendment 12 (1993); Amendment 2

(1995); Amendment 13 (1996)

International Electrotechnical Commission (IEC)

IEC 60601-1:2005, Medical Electrical Equipment — Part

1: General Requirements for Basic Safety and Essential

Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2

(2007)

IEC 60601-1:1988, Medical Electrical Equipment — Part 1:

General Requirements for Safety - Second Edition; Amendment

1 (1991); Amendment 2 (1995); Corrigendum 1 (1995)

Canadian Standards Association (CSA)

CAN/CSA-C22.2 No. 60601-1:08, Medical Electrical Equipment

— Part 1: General Requirements for Basic Safety and Essential

Performance

American National Standards Institute (ANSI)/Association for

the Advancement of Medical Instrumentation (AAMI)

ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment —

Part 1: General Requirements for Basic Safety and Essential

Performance; Consolidated Reprint (2009); Amendment 2

(2010)

European Committee for Electrotechnical Standardization

(CENELEC)

EN 60601-1:2006, Medical Electrical Equipment — Part

1: General Requirements for Basic Safety and Essential

Performance; IEC Corrigendum 1 (2006); IEC Corrigendum 2

(2007); CENELEC Corrigendum (2010); CENELEC Amendment

A11 (2011)

12 www.stryker.com

EN 0940-001-025 Rev-L

Guidance and manufacturer’s declaration - electromagnetic emissions

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Cast Cutter (REF

0941-000-000) should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The Cast Cutter (REF 0941-000-000) 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 Cast Cutter (REF 0941-000-000) is suitable for use in all establishments other than domestic

establishments 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

Guidance and manufacturer’s declaration - electromagnetic immunity

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Cast Cutter (REF

0941-000-000) should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

Portable and mobile RF communications equipment should be used no closer

to any part of the Cast Cutter (REF 0941-000-000), including cables, than the

recommended separation distance calculated from the equation applicable to the

frequency of the transmitter.

Recommended separation distance:

d=1.2√P

150 kHz to 80 MHz

d=1.2√P

80 MHz to 800 MHz

d=2.3√P

800 MHz to 2.5 GHz

Where Pis the maximum output power rating of the transmitter in watts (W)

according to the transmitter manufacturer and dis the recommended separation

distance in meters (m). Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey,ashould be less than the compliance level

in each frequency range.bInterference may occur in the vicinity of equipment

marked with the following symbol:

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio

broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an

electromagnetic site survey should be considered. If the measured field strength in the location in which the Cast Cutter (REF 0941-000-000) is used exceeds the

applicable RF compliance level above, the Cast Cutter (REF 0941-000-000) should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as re-orienting or relocating Cast Cutter (REF 0941-000-000).

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

0940-001-025 Rev-L EN

www.stryker.com 13

Guidance and manufacturer’s declaration - electromagnetic immunity

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the Cast Cutter (REF

0941-000-000) should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment -

guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±2, ±4, ±6 kV contact

±2, ±4, ±8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

±2 kV for power supply lines

±1 kV for input/output lines

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that

of a typical commercial or hospital

environment.

Voltage dips, short interruptions and

voltage variations on power supply

input lines

IEC 61000-4-11

<5% UT

(>95% dip in UT)

for 0,5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95% dip in UT)

for 5 sec

95% Reduction (10ms)

60% Reduction (100ms)

30% Reduction (500ms)

95% Reduction (5s)

Mains power quality should be that

of a typical commercial or hospital

environment. If the user of the Cast

Cutter (REF 0941-000-000) requires

continued operation during power

mains interruptions, it is recommended

that the Cast Cutter (REF 0941-

000-000) be powered from an

uninterruptible power supply or a

battery.

Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m 3 A/m

@ 50Hz

CRT 1A/m

Power frequency magnetic fields

should be at levels characteristics of a

typical location in a typical commercial

or hospital environment.

NOTE: UTis the alternating current mains voltage prior to application of the test level.

Recommended separation distances between portable and mobile RF communications equipment and the Cast Cutter (REF 0941-000-000)

The Cast Cutter (REF 0941-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or

the user of the Cast Cutter (REF 0941-000-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile

RF communications equipment (transmitters) and the Cast Cutter (REF 0941-000-000) as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum output

power of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

d=1.2√P

80 MHz to 800 MHz

d=1.2√P

800 MHz to 2.5 GHz

d=2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

11. 2 1. 2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using the equation

applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.