KINCISE System 4-Port Battery Charger Instructions for Use PDF download

KINCISE™ System 4-Port Battery Charger

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Contents General Information... 1 Symbols Glossary... 4 System Operation... 5 Cleaning... 8 Inspection and Functional Testing... 9 Environmental Conditions

10

Troubleshooting... 11 Maintenance and Repair... 12 Disposal and Recycling... 12 Technical Specifications... 13

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General Information List of Devices Reference No.

Description

Countries Used In

1003-00-101

KINCISE™ System 4-Port Battery Charger

All

1002-00-102

KINCISE™ System Rechargeable Lithium-ion Battery

All

1003-00-001

KINCISE™ System Power Cord, three-pole, IL

Israel

1003-00-002

KINCISE™ System Power Cord, three-pole, GB/SG

United Kingdom, Singapore

1003-00-004

KINCISE™ System Power Cord, three-pole, AU/NZ

Australia, New Zealand

1003-00-005

KINCISE™ System Power Cord, three-pole, Europe/KR

Europe, Korea

1003-00-006

KINCISE™ System Power Cord, three-pole, CH

Switzerland

1003-00-009

KINCISE™ System Power Cord, three-pole, JP/TH

Japan, Thailand

Device Description The KINCISE System 4-Port Battery Charger is a reusable device that charges and provides diagnostic feedback for the KINCISE System Rechargeable Lithium-ion Battery.

Indications for Use The KINCISE Surgical Automated System is intended for use in delivering power to accessories to impact hard tissue or bone during surgical procedures.

Intended User The KINCISE System 4-Port Battery Charger is intended to be used by Physicians, licensed health care providers, Operating Room Staff and Central Processing Personnel.

Intended Use The KINCISE System 4-Port Battery Charger is intended for charging KINCISE System Batteries. The KINCISE Surgical Automated System is intended for use in delivering power to accessories to impact hard tissue or bone during surgical procedures.

Patient Target Group There are no restrictions on patient population or medical conditions, as the KINCISE 4-Port Battery Charger is not intended for use near the patient or in a clinical setting.

Contraindications There are no device specific contraindications associated with the KINCISE 4-Port Battery Charger as it is not intended for use near the patient or in a clinical setting.

Latex Information Not made with natural rubber latex.

Warranty & Return Policies Warranty and return policies are available upon request. Warning: A ll Instrument System components returned should be properly cleaned and sterilized as applicable prior to shipping.

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Warning: T ransmissible Spongiform Encephalopathies (TSE) DePuy Synthes will not authorize or accept the return of products that have been in directly contact with a patient or contaminated with a patient’s body fluids who is suspected or confirmed with a Transmissible Spongiform Encephalopathies/ Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. DePuy Synthes recommends that all devices used on an affected or possibly affected patient be safely disposed of in accordance with local procedures and guidelines. It is recommended to treat the patient using single-use instruments.

Customer Service Contact the manufacturers Customer Service for Troubleshooting. For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices): if during the use of this device or as a result of its use, a serious incident has occurred, please report to the manufacturer and /or authorized representative and to your national authority.

Warning •

Read and understand the manufacturer’s instructions for all devices used. Failure to follow instructions may result in injury.

•

Do not use if product package has been damaged or opened.

•

Do not use if sterilization barrier has been or its packaging is compromised.

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Visually inspect device/component for damage before using: do not use if damage or wear is evident (Unrecognizable markings, missing or removed part numbers, corrosion, etc.)

•

Always keep Mains Power Cord and Battery Charger away from heat to prevent damage to housing, internal parts and power cord insulation which may result in risk of electric shock or fire.

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Employ a regular care regimen for the Battery Charger that includes routine cleaning and inspection for damage.

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Any protective covers and films must be removed before cleaning and use.

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Do not use if damage, wear, corrosion, or missing parts are apparent or the inspection or functional testing criteria are not met.

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Do not operate the Battery Charger in the surgical field or in any area where the patient is or may be present.

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Do not operate in an explosive flammable environment.

• •

the cord or Battery Charger and create an electric shock hazard. •

Always have a second fully charged battery back readily available during use.

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Do not use any other chemicals than those recommended in these instructions.

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Always locate the Mains Power Cord to an area that it will not be stepped on, tripped over, come in contact with sharp edges, moving parts and/or otherwise subjected to damage, water, or stress.

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Always disconnect the Battery Charger from the power outlet when not in use and before cleaning and inspecting. This will reduce the risk of electric shock or damage to the Battery Charger.

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Only operate Battery Charger in a well-ventilated area. To allow proper ventilation, do not block Battery Charger vents.

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Only use the Battery Charger for its intended use.

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To avoid the risk of electric shock do not use accessories, transducers, and cables other than those specified and sold by the Manufacturer of this device as replacement parts for internal components, may result in increased Emissions or decreased Immunity of the KINCISE System 4-Port Battery Charger. This equipment must only be connected to supply mains with protective earth.

•

Use of damaged or improperly maintained power equipment and/or misused powered equipment can result in excessive temperatures.

Do not use in oxygen rich environment.

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Do not use with accessories or devices other than those specified in these instructions.

Use caution when handling sharp instruments to avoid cutting or tearing gloves.

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Only use clean and dry Battery with the Battery Charger.

Use standard protocol for disposal of sharp instruments.

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Do not modify ground or power cord.

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Always grasp the Mains Power Cord by the plug when disconnecting from receptacle. Do not use the Mains Power Cord to carry the Battery Charger. Pulling on the Mains Power Cord itself may damage

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Use of accessories or cables other than those provided by DePuy Synthes Power Tools and specified for use with KINCISE Surgical Automated

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System may result in increased emissions or decreased immunity. •

•

• •

Use of the KINCISE Surgical Automated System adjacent to or stacked with other equipment should be avoided because it could result in improper • operation. If such uses are necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The KINCISE Surgical Automated System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this accompanying documentation.

•

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 area (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 reorienting the equipment. Portable and Mobile RF communications equipment • can affect Medical Electrical Equipment.

The use of accessories, transducers, and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic Immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the KNICISE Surgical Automated System including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Power source should comply with applicable IEC, CEC, and NEC requirements. Grounding reliability can only be achieved when this equipment is connected to a receptacle marked “HOSPITAL GRADE.” No modification of this equipment is allowed. Modifications could result in loss of electrical safety. Dispose of items contaminated with body fluids with other biohazardous waste. Always avoid contact with the Battery Charger terminals while its connected to a power supply. Contacting the terminals with metal objects such as rings and other jewelry could result in a burn injury, fire and/or product damage.

Cautions •

Always maintain a firm grip on the Battery Charger • and accessories to prevent damage due to dropping.

Do not store the Battery Charger with an attached Battery.

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Do not expose the Battery Charger to environmental conditions outside the limitations specified in these instructions.

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United States Federal law restricts this device to sale by or on order of a physician or other licensed healthcare provider.

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Do not sterilize the Battery Charger.

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Do not disassemble or attempt to repair the Battery Charger.

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Symbols Glossary

V

Catalogue Number (Ref. 5.1.6 ISO 15223-1)

Serial Number (Ref. 5.1.7 ISO 15223-1)

Humidity Limitation (Ref. 5.3.8 ISO15223-1)

Authorized Representative in the European Community (Ref. 5.1.2 ISO 15223-1)

Atmospheric Pressure Limitation (Ref. 5.3.9 15223-1)

Manufacturer and Date of Manufacture (Ref. 5.1.1 ISO 15223-1)

Temperature Limit (Ref. 5.3.7 ISO 15223-1)

Date of Manufacture (Ref. 5.1.3 ISO 15223-1)

Consult Instructions for Use (Ref. 5.4.3 ISO15223-1)

Keep Dry (A.K.A. Protect from Moisture) (Ref. 5.3.4 ISO 15223-1)

Prescription only (21 CFR 801.109) United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider

CE Mark Conformité Européenne (MDR 2017/745)

Indicates position or location

DO NOT THROW IN TRASH (EN 50419)

Volts

VA

Volt Amperes

CAUTION: Refer to accompanying documentation (Ref. 5.4.4 ISO 15223-1)

Hz

Hertz

W

Watt

Alternating Current (IEC 60417-5031) Direct Current (IEC 60417-5032)

W/port

Class II equipment per (IEC 60417-5172) BFP

Back Feed Protection

Watts per port Certified/Accredited Test House

GTIN

Global Trade Item Number

Packaging Unit (ISO 7000-2794) Indicates the number of pieces in the package

Medical Device

Do not open if package is damaged (Ref. 5.2.8 ISO 15223-1)

Unique Device Identifier

Batch Code (Ref. 5.1.5 ISO 15223-1)

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System Operation Warning: •

Only use clean and dry Battery with the Battery Charger.

Attaching a Battery 1. Align Battery raised ribs with Charger Port grooves. 2. Slide Battery into Charger Port (see Fig. 1). Note: •

Ensure the Battery contacts are engaged with the contacts in the Charger Port.

•

Only use KINCISE Rechargeable Lithium-ion Battery (1002-00-102). See IFU provided with Battery for instructions.

Removing a Battery 1. While holding the Battery Charger in place, pull the Battery out of the Charger Port to remove. See Fig. 2

Fig. 1

Fig. 2

Display Panel Indicators The Indicators located on the Display Panel of the Battery Charger are defined in this section. Display Panel Indicator

Definition EVALUATE Flashes to indicate the Battery Charger is communicating with the Battery to determine compatibility. TEMPERATURE Flashes to indicate the internal Battery temperature sensor is too hot or too cold for charging. Note: When the Battery internal temperature reaches an acceptable level, charging will start automatically. DEFECTIVE BATTERY Flashes to indicate the inserted Battery is defective. Note: • The Battery Charger will not charge a defective Battery. •

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Do not use a defective Battery. Contact your Sales Representative for disposition and replacement.

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Display Panel Indicator

Definition CHARGE CYCLE COUNT Indicates the count of charge cycles a Battery has incurred. Note: • The Charge Cycle Count increments by 1 (one), once charging begins. •

Following 100 charge cycles, the Battery will not allow additional charging and must be properly disposed. Reference the Disposal and Recycle section of the Battery Instructions for Use.

•

The Charge Cycle Count of a fully charged Battery will not increment when inserted into the Battery Charger.

STATE OF CHARGE Indicates Battery state of charge: • First bar flashing: <25% charge •

Second bar flashing: 25% - 49% charge

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Third bar flashing: 50% - 74% charge

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Fourth bar flashing: 75% - 99% charge

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Four bars ON (not flashing): 100% charge

Initial Use Follow the instruction below before using the Battery Charger for the first time. 1. The Operator should stand in front of the Battery Charger such that the Charger Ports are easily accessible and display panel is clearly visible. 2. Place the product on a non-slip surface that is even and of sufficient strength to hold the Battery Charger and Battery. Do not position the Battery Charger such that it is difficult to disconnect the power cord. 3. To power the Battery Charger ON, connect the Battery Charger to a grounded 100-240V AC wall receptacle using only the supplied Mains Power Cord. 4. The display panel backlight on the front of the Battery Charger will illuminate blue when the device is powered on. 5. Consult the Troubleshooting section of these Instructions for Use if the Battery Charger display panel backlight does not illuminate. 6. To Power the Battery Charger OFF, remove the Mains Power Cord from the wall receptacle.

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Battery Charging Follow the instruction below for charging the Battery with the Battery Charger. 1. Connect Battery Charger to power source. •

Remove all Batteries from Battery Charger before connecting to power source.

•

Insert appropriate end of the country specific Mains Power Cord into the Battery Charger Power Cord Socket.

•

Insert the Mains Power Cord plug into grounded wall outlet.

•

All four displays will be blank with back-light ON. See Fig. 3. AMBER LED

GREEN LED

OFF

CHARGING PORT DISPLAY PANEL

BLANK DISPLAY PANEL

Fig. 3 2. Insert Battery into Charger Port. •

Slide the Battery into Charger Port.

•

Ensure the Battery contacts are engaged with the contacts in the Charger Port.

•

The Amber LED and Evaluate indicator will flash. See Fig. 4. AMBER LED

GREEN LED

FLASHING

OFF

CHARGING PORT DISPLAY PANEL

Fig. 4 Note: The Amber LED and Evaluate indicator flash quickly and may be difficult to detect. 3. Charge Battery. •

Charging is initiated following successful communication between Battery Charger and Battery.

•

The Green LED will flash during charging. See Fig. 5.

•

The state of charge indicator will show flashing bar(s) during charging. See Fig. 5.

•

The Charge Cycle Count Indicator will show the current charge cycle count of the Battery. AMBER LED

GREEN LED

OFF

FLASHING

CHARGING PORT DISPLAY PANEL

Fig. 5

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Note: •

Communication should take place shortly after Battery Insertion.

•

Charging will normally complete in less than one hour.

•

The Battery may become slightly warm to the touch while charging; this is normal and does not indicate a problem.

4. Charge Complete. •

When charge is complete, all four bars will be ON (none flashing) in the state of charge indicator. See Fig. 6.

•

Remove Battery from Battery Charger. Remove the Battery from Charger Port upon completion of charge. The back-light will remain ON. See Fig. 3.

Note: If the Battery is removed prior to charge completion, the display and LED may continue flashing for several seconds before the display is blank and the LEDs turn OFF. AMBER LED

GREEN LED

OFF

ON

CHARGING PORT DISPLAY PANEL

Fig. 6

Cleaning DePuy Synthes recommends facilities using the Battery Charger employ a regular care regimen that includes routine cleaning and inspection for damage.

Warning: •

Do not use any other chemicals than those recommended in these instructions.(See recommended chemicals below.)

•

Only use the manual cleaning method in these instructions to clean the Battery Charger.

•

Always remove any Battery from the Battery Charger before cleaning.

•

Always perform the inspection and functional testing procedure as specified in these instructions after cleaning.

Caution: •

Always maintain a firm grip on the Battery Charger and accessories to prevent damage due to dropping.

•

Always prepare the detergent solution per the detergent manufacturer’s Instructions for Use.

•

Do not use sharp, hard, abrasive, pointed or metal cleaning aids (e.g. pipe cleaners, wire bristle brushes, etc.) to clean the Battery Charger.

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Do not bend Battery Charger Terminals during cleaning.

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Do not use ultrasonic equipment.

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Do not use automated washer.

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Do not immerse.

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Do not allow liquid to soak into the terminals or openings.

Recommended Supplies •

Neutral pH Enzymatic Detergent (pH 7.5 and 9.5)

•

Soft lint-free cloth(s)

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•

Various sized soft bristle nylon brushes

•

Critical water (high purity water generated by processes such as RO, deionization or distillation)

1. Disconnect the Battery Charger from power source. See Fig. 7 and 8.

Fig. 7

Fig. 8

2. Remove all Batteries from the Battery Charger. 3. Prepare a fresh batch of neutral pH enzymatic detergent solution according to the detergent manufacturer’s instructions. 4. Using lint free cloth(s) presoaked in detergent solution, wipe all device surfaces with cloth for a minimum of two (2) minutes to remove all visible soil. Brush crevices and mating surfaces using a soft bristled nylon brush soaked in detergent solution. 5. Using lint free cloth(s) presoaked in critical water (high purity water generated by processes such as RO, deionization or distillation), wipe all device surfaces for a minimum of two (2) minutes to remove residual soil, debris, and detergent. Brush crevices and mating surfaces using a soft bristled nylon brush soaked in critical water (high purity water generated by processes such as Reverse Osmosis, deionization or distillation). 6. Visually inspect Battery Charger surfaces for any remaining soil. If soil is observed, repeat steps 3-6 using a new presoaked cloth, brush, and fresh batch of detergent solution. •

Pay close attention to crevices, mating surfaces and any hard-to-reach areas.

7. Dry each Battery Charger using a clean soft lint-free cloth. •

Pay close attention to crevices, mating surfaces and any hard-to-reach areas where moisture can accumulate.

8. Ensure the Battery Charger is completely dry before reconnecting to power source.

Inspection and Functional Testing Warning: •

Do not use if damage, wear, corrosion, or missing parts are apparent or the inspection of functional testing criteria are not met.

•

Only use a clean and dry Battery with the Battery Charger.

•

All products returned to DePuy Synthes should be properly cleaned, disinfected and sterilized as applicable prior to shipping.

Note: •

Contact your Sales Representative for instructions on returning product to DePuy Synthes Power Tools.

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Inspection 1. Visually inspect the cleaned Battery Charger and Mains Power Cord for damage and wear. Reference the following bulleted examples: •

Damage: (e.g. cracked, dented, or separated housing, physical imperfections that can cause damage or injury, nicked, or cut Mains Power Cord, etc.)

•

Wear: (e.g. corrosion, removed or illegible part numbers, symbols, and markings, etc.)

2. If damage or wear is detected, contact your Sales Representative for disposition and replacement. Do Not use a Battery Charger with damage or wear. 3. If no damage or wear is detected, immediately proceed to the functional testing instructions below.

Functional Testing 1. Insert the Battery into the left Charger Port of the Battery Charger. 2. Verify the Display Panel and LEDs operate as indicated in the System Operation section of these Instructions for Use. 3. If the Charger Port does not operate properly, consult the Troubleshooting section of these Instructions for Use. 4. Repeat the functional testing steps 1-3 for the remaining three Charger Ports.

Environmental Conditions Caution: •

Always follow the recommended operating, transportation and storage conditions from Table 1.

Table 1: E nvironmental Conditions Environmental Conditions Operating: 10-27°C

Temperature

Transportation and Storage: -29-60°C for max 72h Operating: 30-90%

Relative Humidity

Transportation and Storage: 10-90%

Atmospheric Pressure

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Operating: 700-1060 hPa Transportation and Storage: 595-1060hPa

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Troubleshooting Problem

Possible Cause

Solution

No LED lights appear and display panel backlight is OFF

Mains Power Cord is not plugged in.

Connect Mains Power Cord to Battery Charger and plug into the wall receptacle.

Wall receptacle power is interrupted.

Verify power is present at wall receptacle. Unplug Battery Charger for 60 seconds and plug into the wall receptacle.

Mains Power Cord or Battery Charger is damaged.

Contact your Sales Representative for assistance.

Battery is not fully seated in Charger Port.

Press Battery to ensure contacts on Battery are properly engaged with contacts in Charger.

Battery Charger requires power off reset.

Unplug Charger for 60 seconds and plug into the wall receptacle.

Contacts are dirty.

Carefully clean contacts.

Battery not recognized.

Only use a KINCISE System Rechargeable Lithium-ion Battery.

Charger or Charger Port is defective.

Move Battery to a different Charger Port for charging. Charge a different Battery on the same Charger Port. If none of the Batteries will charge, contact your Sales Representative for assistance.

Battery has reached 100 Battery Charger Cycles (End of Service Life).

Contact your Sales Representative for Battery replacement.

Battery is defective (indicator is flashing).

Move Battery to a different Charger Port for charging. Charge a different Battery on the same Charger Port. If the different Charger Port doesn’t charge and the different Battery charges, Contact your Sales Representative for assistance.

Wrong Battery orientation.

Reorient Battery with Battery contacts facing Battery Charger contacts.

Unauthorized Battery.

Only use a KINCISE System Rechargeable Lithium-ion Battery.

Battery Charger contacts or housing is damaged.

Unplug Mains Power Cord from wall outlet and do not use Battery Charger. Contact Sales Representative for assistance.

Battery contacts or housing is damaged.

Do not use Battery. Contact your Sales Representative for assistance.

Battery does not charge.

Battery will not insert into Charger Port.

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Note: •

For further technical support and product related questions, contact your Sales Representative.

•

Always have the product catalog number and serial number available when communicating with your Sales Representative or Depuy Synthes Power Tools Customer Service Department regarding your KINCISE Surgical Automated System products.

Maintenance and Repair Warning: •

All products returned to DePuy Synthes should be properly cleaned, disinfected and sterilized as applicable prior to shipping.

•

No modification of this equipment is allowed. Modifications could result in loss of electrical safety.

Caution: Do not disassemble or attempt to repair the Battery Charger.

Note: •

Other than the instructions identified in these Instructions for Use, no further maintenance or repair work may be carried out independently or by third parties.

•

Contact your Sales Representative for instructions on returning product to DePuy Synthes Power Tools.

Disposal and Recycling Warning: •

Dispose of items contaminated with body fluids with other biohazardous waste.

•

At end of life recycle or dispose of device in accordance with local and national regulations.

•

All products returned to DePuy Synthes should be properly cleaned, disinfected and sterilized as applicable prior to shipping.

Note: •

Contact your Sales Representative for instructions on returning product to DePuy Synthes Power Tools.

Device Lifetime If the Battery Charger fails to meet the criteria defined in the Inspection and Functional Testing Section, it has reached its end of life and shall not be used.

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Technical Specifications The device complies with the following standards: AAMI ES60601-1 Issued: 2006/03/09 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, Amendment 1 – 2012 CSA C22.2#60601-1 Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) EN 60601-1: 2005 + A1:2013, IEC 60601-1 / EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (CB Scheme) IEC 60601-1-6:2010 (Third Edition) + A1:2013 for use in conjunction with IEC62366:2007 (First Edition) + A1:2014 and IEC 60601-1:2005 (Third Edition) + Corr.1 (2006) + Corr.2 (2007) + A1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Ad.3.1), Medical electrical equipment Part 1-6 General requirements for safety Collateral Standard: Usability IEC 60601-1-6 Issued: 2013/10/29 Ed: 3 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability; Amendment 1 IEC 60601-1-2:2014 (Edition 4) Collateral Standard: Electromagnetic Compatibility- Medical Electrical Equipment. IEC 62366 Medical devices – Application of usability engineering to medical devices IEC 62366: 2007 (First Edition) + A1: 2014 (CB Scheme) Battery Charger (1003-00-101) Specifications Primary: 100-240V~, 50/60Hz, 250 – 190 VA Class II ME Equipment Protection against harmful ingress of water or particulate matter: IPX0 (Ordinary Equipment, no protection) Applied Part Classification: No applied parts. Mode of Operation: Continuous Duty Guidance and manufacturer’s declaration – electromagnetic emissions The KINCISE System is intended for use in the electromagnetic environment specified below. The customer or the user of the KINCISE System should assure that it is used in such an environment. Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Emissions test

Group 1

The KINCISE System 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.

Conducted RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

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The KINCISE System is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes.

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Guidance and manufacturer’s declaration – electromagnetic immunity The KINCISE System is intended for use in the electromagnetic environment specified below. The customer or the user of the KINCISE System should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

±8 kV contact

±15 kV air

±2 kV for AC lines ±1 kV for I/O lines 100kHz Pulse Repetition Frequency

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-5

±0.5, 1kV line to line ±0.5, 1, 2 kV line to earth

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

0% UT (100% dip in UT) for 0.5 periods) at 0°, 45°, 90°,135°, 180°, 225°, 270°, 315°

IEC 61000-4-11

0% UT (100% dip in UT) for 1 period)

70% UT (30% dip in UT) for 25 periods (50Hz) 30 periods (60Hz)

Interruptions 0% UT (100% dip in UT) for 250 periods (50Hz) 320 periods (60Hz)

Interruptions 0% UT (100% dip in UT) for 250 periods (50Hz) 320 periods (60Hz) *

30 A / m

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge

Power frequency (50/60 Hz) Magnetic field IEC 61000-4-8

Mains power quality should be that of a typical commercial or hospital environment. (*) If the user of the KINCISE System requires continued operation during power mains interruptions, it is recommended that the KINCISE system be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the A.C. mains voltage prior to application of the test level.

2020-09-02 05:38:39

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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English

Guidance and manufacturer’s declaration – electromagnetic immunity The KINCISE System is intended for use in the electromagnetic environment specified below. The customer or the user of the KINCISE System should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the KINCISE System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

6 Vrms in ISM bands 150 kHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz

80% at 1kHZ (AM modulation)

Recommended separation distance

d 1. 2 P 80 MHz to 800 MHz d 2.3 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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. a

ield strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land F 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 KINCISE System is used exceeds the applicable RF compliance level above, the KINCISE System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the KINCISE System.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.

2020-09-02 05:38:39

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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English

Recommended separation distances between portable and mobile RF communications equipment and the Kincise System The KINCISE System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KINCISE System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KINCISE System 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

80 MHz to 800 MHz

W

800 MHz to 2,5 GHz

d 2.3 P

0,01

0.12

0.23

0,1

0.38

0.73

1

1.2

2.3

10

3.8

7.3

100

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is 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.

2020-09-02 05:38:39

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Anspach

KINCISE Surgical Automated System

KINCISE System 4-Port Battery Charger Instructions for Use