ConMed Linvatec The PowerPro Model PRO 3600 Instruction Manual Rev AA July 2010

Proprietary Information This manual contains information deemed proprietary to Linvatec Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed Linvatec. ConMed Linvatec reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.

Linvatec, Hall, SureCharge, PowerPro, PowerProMax, MPower and MPower 2 are trademarks or registered trademarks of Linvatec Corporation.

 Linvatec Corporation 2005, 2010. All Rights Reserved. Printed in USA

Record the Model and Serial Numbers of the charger and date received. Retain for future reference. Charger Model No. Charger Model No.

Serial No Serial No

Date Date

Table of Contents

1.0

2.0

3.0

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Warnings and Precautions... 2 1.2.1

Warnings... 2

1.2.2

Precautions... 3

1.3

Symbol Definitions... 4

1.4

Environmental Directives... 6

1.5

Product Photographs... 6

1.6

Battery Charger... 7 1.6.1

Front Panel... 7

1.6.2

Rear Panel... 8

BATTERY CHARGER OPERATION 2.1

Charging Battery Packs without the SureCharge Sterilization/Charging Case... 11

2.2

Charging Standard Large (PRO3010) and Small (PRO3020) Battery Packs using the SureCharge Sterilization/Charging Case... 12

2.3

Charging Sterile Transfer Batteries... 16

MAINTENANCE 3.1

Cleaning and Sterilizing... 21 3.1.1

Cleaning Precautions... 21

3.1.2

Cleaning Instructions for the Battery Charger... 22

3.1.3

Cleaning Instructions for the Charging Platform... 23

3.1.4

Cleaning Instructions for the Sterile Transfer Shroud, Sterile Transfer Battery Case and Sterile Transfer Battery... 23

3.1.5

Cleaning Instructions for Battery Packs... 24

3.1.6

Cleaning Instructions for the Charging Case... 25

3.1.7

Sterilization Information... 25

i

Table of Contents

Page

3.2

Troubleshooting... 29

3.3

Fuse Replacement... 32

3.4

Ground Bond Test... 32

3.5

Leakage Test... 33

3.6

Technical Specifications... 34 3.6.1

Battery Charger (PRO3600)... 34

3.6.2

System Environmental Requirements... 35

3.6.3

Power Cord Requirements for Battery Charger... 35

3.6.4

Batteries... 36

3.7

Accessories... 42

3.8

Customer Service... 43 3.8.1

Assistance... 43

ii

1.0 INTRODUCTION

The Standard Large Battery Pack (PRO3010) and Standard Small Battery Pack (PRO3020) can be charged after sterilization by placing them in the SureCharge® Sterilization/Charging Case. Charging the battery packs after sterilization prevents a loss of charge in the battery due to the extreme heat of the sterilization environment, thus allowing for longer use during surgery. When battery packs are charged after sterilization, they can either be transferred to the sterile field via the use of the SureCharge Sterilization/Charging Case or stored ready for use.

It is recommended that personnel study this manual before attempting to operate, clean and/ or sterilize the Hall® PowerPro® Battery Charger (PRO3600), batteries and accessories. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices and instructions marked on the product, and included in this manual and any associated information insert.

1.1

Intended Use

The PowerPro Battery Charger is used to charge all PowerPro batteries, which includes the following: • Sterile Transfer Batteries (PRO3115 and PRO3520) • Standard Large Battery Pack (PRO3010) • Standard Small Battery Pack (PRO3020) • Trauma Battery Pack (PRO3030) • Large 12 Volt Battery Pack (PRO3011) All batteries may be charged prior to sterilization by placing the battery pack directly on the battery charger. The Sterile Transfer System requires that only the Sterile Transfer Battery Case (PRO3110 and PRO3521) and Sterile Transfer Shrouds (PRO3130 and PRO3531) be sterilized, not the battery. The battery only needs to be cleaned, and then charged using the Charging Platform (PRO3135 or PRO3535). This eliminates the loss of charge in the battery due to the extreme heat of the sterilization environment. Once charged, the battery is transferred into the sterile battery case within the surgical field. 1

1.2

Warnings and Precautions

1.2.1 1.

This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Prior to using the device, read and follow all warning and precautionary notices and instructions marked on the product and included in this manual.

2.

Do not open or attempt to service the battery charger, as this may void the warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks. If the system malfunctions, return it for service.

3.

Do not short circuit the battery terminals or allow them to come into contact with metal objects. This could cause a shock or burn injury and also damage the battery.

4.

Do not expose batteries to fire or incineration. Exposure can cause injuries.

5.

Use only one battery and one shroud per battery case per procedure. Do not reuse the shroud without sterilizing it first. Do not put a second battery into the battery case without sterilizing the case first. Sterility may be compromised and patient infection may occur.

STOP DO NOT bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or damage. The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a Warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment. NOTE: Supplementary information may be given in a NOTE. This information has no critical effect on the patient or equipment.

2

Warnings

6.

7.

8.

9.

Inspect battery pack for damage (i.e., cracks in battery case or cell casing) prior to use or charging. Do not use or charge damaged battery packs. If battery pack is damaged and leakage or residue is noticed, do not allow it to come in contact with skin, eyes or clothing. These materials could contain Potassium Hydroxide (KOH) which is an alkaline and can burn. If leakage or residue comes in contact with skin or eyes, flush affected area with copious amounts of water and seek medical attention immediately.

1.2.2

Inspect the Sterile Transfer Battery Case for any damage, such as: cracks in the case or damaged, broken, or worn gasket, latch, and/or hinge. If damage is found, do not use. Sterility may be compromised and patient infection may occur. Do not use any equipment, especially the battery charger, in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking.

1.

United States Federal law restricts sale of this device to or on the order of a physician.

2.

Do not expose the battery charger to moisture, operate in wet areas, or place liquids on or above the unit.

3.

Prior to use, inspect all equipment for proper operation.

4.

Do not handle the battery charger by the cord. Do not pull on the power cord or accessory cord to remove it from the battery charger or the power outlet.

5.

Do not excessively bend or kink the battery charger power cord or accessory cord. Always inspect cords for signs of excessive wear or damage. If wear or damage is found, discontinue use and replace immediately.

6.

Allow adequate air ventilation below and behind the battery charger. Do not block air vents located on the back of the charger. Ensure there are at least 8 inches of free air-space along the back of the charger for proper ventilation. Do not block air vents on the underside of the battery charger by placing a towel or anything under the charger. Do not drape or cover charger. Impeding air flow will cause the charger to overheat and shut down.

7.

Do not immerse battery pack in any liquid or solution. Contact corrosion may occur resulting in decreased performance of the battery and/or handpiece.

Equipment grounding is vital to ensure safe operation. Plug the power cord of the battery charger into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices defeat the safety ground and could cause injury.

3

Precautions

Rx ONLY

8.

9.

Battery packs contain nickel cadmium or nickel metal hydride, which must be recycled or disposed of properly. The disposal of nickel cadmium or nickel metal hydride batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and government regulations. In the U.S. call 1-800-925-4255 for additional information on battery pack disposal or recycling. Outside the U.S. contact your local ConMed Linvatec representative.

1.3

Symbol Definitions Power “ON”, connected to mains. Power “OFF”, disconnected from mains. Power on, Stand-by mode.

Follow instructions for use.

If a battery pack is being returned to the manufacturer, it must be completely discharged prior to shipping.

Precaution or warning notice

10. Do not process battery packs in a washer / sanitizer. Contact corrosion may occur resulting in decreased battery and / or handpiece performance.

Warning - For continued protection against risk of fire, replace only with the same type and rating fuse.

11. Thoroughly clean the battery charger as needed (See “3.1 Cleaning and Sterilizing” on page 21).

Mains Fuse. Type BF equipment. Pertains to the Battery Pack.

12. The service interval is required to keep the PowerPro Battery Charger at its optimum operating performance. (See “3.0 MAINTENANCE” on page 21).

~

Alternating Current. Protective earth ground. Electrical hazard. Dangerous voltages are present. Never attempt to repair the equipment. Only trained service personnel may remove the cover, or obtain access to the system components.

No user service recommended. Refer servicing to qualified ConMed Linvatec service personnel.

4

Indicates product component should not be sterilized.

Humidity limits for storage and transport

Indicates product component should not be immersed in any type of fluid.

Pressure limits for storage and transport

Warning: Burn potential. Caustic materials.

Waste Electronics and Electrical Equipment (WEEE) Symbol. Regarding European Union endof-life of product.

Single Use Only. Flammable Anesthetics - Risk of explosion if used in the presence of flammable anesthetics

Indicates battery is being charged when illuminated.

Batteries contain either nickel cadmium or nickel metal hydride which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-925-4255, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling.

Indicates battery is fully charged when illuminated.

Indicates a battery fault. See “3.2 Troubleshooting” on page 29 for more information. Indicates that a battery is going through a quick-discharge cycle when blinking, and remains constantly lit when completely discharged. Rx ONLY

Caution: Federal Law restricts this device to sale by or on the order of a physician. Temperature limits for storage and transport

5

1.4

Environmental Directives

1.5

WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive.

Product Photographs

The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed Linvatec.

6

❶ ❷ ❸ ❹

❺ ❻

1.6

Battery Charger

1.6.1

Front Panel

❹ Battery Fault Indicator Light -

Steadily illuminates when there is a battery fault. See “3.2 Troubleshooting” on page 29 for more information.

❶ Battery Receptacle Platform (4) - Accepts the Charging Platform (PRO3135 and PRO3535) used for charging Sterile Transfer Batteries (PRO3115 and PRO3520); Standard Large Battery Pack (PRO3010); Large 12 Volt Battery Pack (PRO3011); Standard Small Battery Pack (PRO3020); Trauma Battery Pack (PRO3030); and SureCharge Sterilization/Charging Case (PRO3200) used to charge standard battery packs after sterilization.

NOTE: During initial power up, all indicator lights will flash during the selfdiagnostic test.

❺ Discharge Button and Indicator -

Used to discharge standard battery packs prior to sterilization when using the SureCharge Sterilization/Charging Case. Depletes any residual charge that may be remaining in the battery. For discharge of the battery to occur, the discharge button must be activated within the first minute after the SureCharge Sterilization/Charging Case is attached to the battery charger. The indicator will blink during the discharge cycle and stop blinking when discharging is complete.

❷ Charging Indicator Light - Steadily

illuminates to indicate the battery pack is connected and charging.

NOTE: Battery pack must be cooled to room temperature prior to charging. Failure to do this will result in increased charge time.

❻ Power Indicator Light - Illuminates

❸ Charged Indicator Light - Steadily

when the power is in stand-by mode.

illuminates when the battery pack is charged and the charging cycle is complete.

7

❶

❷

❺

❸

❹

1.6.2

❹ Fuse Holder - Contains two fuses. To

Rear Panel

replace fuses see “3.3 Fuse Replacement” on page 32.

❶ Cooling Fan - Removes heat build-up

❺ Mains Power Switch - Place this switch

within the unit.

to the ON position to activate the charger.

PRECAUTION: Do not impede air flow at the rear of the unit. Do not cover or drape. Leave at least 8 inches behind the unit. Do not place directly against a solid surface.

❷ Accessory Outlet - Allows

for a second battery charger to be plugged into the primary charger using the accessory cord (PRO2601). Do not connect more than one charger.

❸ Mains Receptacle - Accepts the supplied hospital grade power cord to provide AC power.

8

2.0

BATTERY CHARGER OPERATION

3.

Any of the above conditions could shorten the life of the batteries and/or compromise the seal integrity, resulting in leakage of Potassium Hydroxide (KOH) which is alkaline and can burn skin, eyes or clothing.

4.

Do not allow battery leakage or residue to come in contact with your skin, eyes or clothing. If leakage does contact your skin, eyes or clothing, flush affected areas with copious amounts of water and seek medical assistance immediately. If there is any evidence of case cracking, white residue or fluid leakage, follow these guidelines:

NOTES: 1.

Batteries are shipped uncharged and non-sterile.

2.

Always clean and sterilize batteries prior to charging. Refer to “3.1 Cleaning and Sterilizing” on page 21 or the information insert supplied with the battery pack for sterilization guidelines and parameters.

3.

Charge batteries before initial use using only the PowerPro Battery Charger (PRO3600).

4.

(a) Handle product with protective gloves.

Do not charge batteries unless they are at room temperature. Failure to do this will result in increased charging time.

(b) Place battery in a leak-proof double bag, lined with absorbent material such as paper toweling. Secure the bag. If battery is damaged, package any loose parts in a separate bag to prevent short-circuiting.

WARNINGS: 1.

Inspect batteries for damage prior to use, i.e., cracks in battery case. DO NOT use or charge damaged batteries. Discard or recycle properly.

2.

Do not autoclave batteries above the recommended temperature, or leave them in the autoclave longer than recommended. See “3.1.7 Sterilization Information” on page 25 or the information insert supplied with the battery pack for sterilization guidelines and parameters. Damage to the battery pack could result, possibly causing injury.

5.

9

Improper fuse size in the charger could result in fire. Replace only with time delay fuses as marked on the charger or listed in “3.6.1 Battery Charger (PRO3600)” on page 34 in the Technical Specifications section.

1.

2.

space along the back of the charger for proper ventilation. Do not block air vents on the underside of the battery charger by placing a towel or anything under the charger. Do not drape or cover charger. Impeding air flow will cause the charger to overheat and shut down.

Ensure the charger is turned off. Plug the power cord into the receptacle on the rear of the charger and a properly earthed mains supply outlet.

A second charger may be powered from the primary charger by connecting the accessory cord (PRO2601) from the second charger to the primary charger’s accessory output.

NOTE: Do not connect more than one charger.

PRECAUTION: Allow adequate air ventilation below and behind the battery charger. Do not block air vents located on the back of the charger. Ensure there is at least 8 inches of free air 10

3.

Using the power switch located on the back of the charger, turn the charger on. The green indicator light on the front of the charger will illuminate.

4.

When initially turned on, the charger will perform a self-diagnostic test, at which time the LED’s will blink and the charger fan will cycle on and off several times. When the charger has satisfactorily completed its diagnostic test, all LED’s will go off indicating that the charger is ready for use. If any LEDs stay illuminated, see “3.2 Troubleshooting” on page 29 for more information.

5.

The charger icons and indicator light colors designate the following:

•

Yellow: Battery is charging.

•

Green: Battery is fully charged.

•

Red:

Battery fault. If the red LED illuminates, see “3.2 Troubleshooting” on page 29 for more information.

2.1

Charging Battery Packs without the SureCharge Sterilization/Charging Case

NOTES: •

This applies to the following Battery Packs: PRO3010 Standard Large Battery Pack; PRO3011 Large 12 Volt Battery Pack; PRO3020 Standard Small Battery Pack; PRO3030 Trauma Battery Pack.

•

Always clean the battery pack prior to charging. Refer to “3.1.5 Cleaning Instructions for Battery Packs” on page 24, or the information insert supplied with the battery pack. Charging must be performed prior to sterilization.

•

1.

Battery packs must be cooled to room temperature prior to charging. Failure to do this will result in increased charging time.

To charge a battery pack, perform the following: (a) Slide the battery pack onto one of the charger receptacles. Ensure it is seated completely in the receptacle. If it is not completely seated, a battery fault (red LED will illuminate) will result (see “3.2 Troubleshooting” on page 29 for more information). Up to four battery packs may be placed on each charger. 11

2.

Charging of the battery pack will begin automatically. During the charge cycle, the yellow “charging” LED will illuminate.

3.

When the battery pack has completed its charge cycle, the yellow “charging” LED will go out and the green “charge complete” LED will illuminate. It takes approximately 55 minutes to obtain a complete charge.

4.

If the red LED illuminates, or no LED illuminates, see “3.2 Troubleshooting” on page 29 for more information.

5.

After charging, sterilize the battery packs. Refer to “3.1.7 Sterilization Information” on page 25 or the information insert supplied with the battery pack for sterilization guidelines and parameters.

6.

To remove the battery pack from the charger, simply slide it off.

2.2

2.

Charging Standard Large (PRO3010) and Small (PRO3020) Battery Packs using the SureCharge Sterilization/ Charging Case

PRECAUTION: Do not charge the PRO3011 Large 12 Volt Battery Pack or PRO3030 Trauma Battery Pack with the SureCharge Sterilization/ Charging Case.

Prior to sterilization, inspect the lid of the case. Ensure the seal is not damaged or missing. Ensure the filter is placed correctly within the designated area of the lid, and the filter bracket is latched correctly. Also ensure there are no tears or holes in the filter, as sterility of the batteries will be compromised and patient infection may occur. If there are any tears or holes, replace the filter. Seal

When using the SureCharge Sterilization/ Charging Case, cleaning and sterilization are performed on the battery packs prior to charging. Reference “3.1 Cleaning and Sterilizing” on page 21. WARNINGS: 1.

Do not short circuit the SureCharge Sterilization/ Charging Case contacts or allow them to come into contact with metal objects. This could cause a shock or burn injury, damage the battery pack and/or the charger.

Latch

12

3.

Do not reuse filters. Filters are single-use only. Whenever the case is opened after sterilization the filter must be removed and disposed of properly.

4.

Inspect the SureCharge Sterilization/ Charging Case for any damage, such as: damaged or worn connectors on the underside or within the case, faulty and/ or missing battery clips, cracks, dents, or broken latches. If damage is found, do not use. Sterility may be compromised and patient infection may occur.

1.

Prior to sterilizing battery packs, remove them from the handpiece and clean them according to “3.1 Cleaning and Sterilizing” on page 21.

2.

Place a new disposable filter onto the underside of the lid: (a) Remove the filter plate by pressing inward on the release knobs.

PRECAUTIONS: 1.

Always clean battery packs prior to placing in the SureCharge Sterilization/Charging Case.

2.

Do not immerse any part of the SureCharge Sterilization/Charging Case in any fluids.

3.

Charge batteries only on the PowerPro Battery Charger (PRO3600).

(b) After removing the filter plate, install a filter by aligning the cutouts in the filter with the brackets on the underside of the lid.

13

(c) Insert the flange of the filter plate behind the metal bar on the underside of the lid.

4.

Slide the metal contacts of the battery pack into the receiving receptacle of the inner basket.

5.

Attach and secure the lid to the case by engaging both side latches of the case lid.

(d) Firmly press on the side tabs until both latches lock into place. A clicking sound must be heard from each latch. 3.

Insert the inner basket into the outer case.

14

(a) During the discharge cycle, the associated yellow LED will blink. When the battery packs are completely discharged, the associated yellow LED will illuminate steadily.

Important: Battery packs must be cooled to room temperature prior to discharging them on the battery charger. Failure to do this will result in an increased discharge time. 6.

7.

Prior to placing the SureCharge Battery Sterilization/Charging Case in the autoclave, and after the battery packs have cooled to room temperature, slide the case onto the PowerPro Battery Charger. Press the discharge button to deplete any residual charge remaining in the battery pack(s).

8.

Remove the SureCharge Battery Sterilization/Charging Case from the battery charger and place it in the autoclave. See “3.1.7 Sterilization Information” on page 25.

9.

After sterilization is complete, and the battery packs have cooled to room temperature, they can be charged. To charge the battery packs:

Important: Battery packs must be cooled to room temperature prior to charging them on the battery charger. Failure to do this will result in increased charging time. (a) Slide the SureCharge Battery Sterilization/Charging Case onto the PowerPro Battery Charger. (b) Charging of battery packs begins automatically. During the charge cycle the yellow “charging” LED will illuminate. (c) When battery packs are completely charged, the yellow “charging” LED will go out and the green “charging complete” LED will illuminate. It will take approximately 55 minutes to obtain a full charge.

NOTE: For discharge of the battery packs to occur, the discharge button must be activated within the first minute after the case is attached to the charger. Once the charging process begins, the discharge button becomes inoperative.

(d) If no LED illuminates, or the red (replace) LED illuminates, see “3.2 Troubleshooting” on page 29 for more information.

15

(e) If all three LEDs flash, this is a system fault. See “3.2 Troubleshooting” on page 29 for more information.

2.3

(f) After battery packs are charged, the case may be removed from the charger and stored ready for use.

Charging Sterile Transfer Batteries

This process applies to the Standard Sterile Transfer System, consisting of: PRO3110 Case, PRO3115 Battery, PRO3130 Shroud, and PRO3135 Charging Platform, and the Small 12 Volt Sterile Transfer System, consisting of: PRO3521 Case, PRO3520 Battery, PRO3531 Shroud, and PRO3535 Charging Platform.

(g) Note that nickel cadmium batteries lose approximately 15 - 20% of their charge per month during storage in nominal room temperature. Recharge periodically to ensure use of a fully charged battery. 10. The circulator will remove the case from the charger, remove the lid from the case, then present the case to the scrub person. 11. The scrub will grasp the handle of the inner basket, remove it from the case, and place it within the sterile field. 12. The scrub will remove the battery pack(s) from the basket and attach one to the handpiece.

16