MicroAire 7500-700 Manual de usuario

7500-700 Battery Charger

Instructions for Use

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Technical Description ........................................................................ 2

Intended Use and Introduction............................................................... 2

General Warnings.......................................................................... 3-4

Symbol Definitions......................................................................... 4-5

Compatible Instruments ..................................................................... 6

Setup and Operation......................................................................... 6

Cleaning/Decontamination .................................................................. 7

Shipping and Environmental Parameters ..................................................... 7

Troubleshooting ............................................................................. 7

Disposal/Recycle............................................................................. 8

Services and Repair .......................................................................... 8

Warranty .................................................................................... 8

Electromagnetic Compatibility ............................................................9-10

Table of Contents

REF 7500-700 Battery Charger Instruction Manual

Technical Description

REF 7500-700

Ratings:

• Class 1 Equipment

• Input Rating: 100-240 V~, 50-60 Hz, 0.30 Kw

Output Rating: 24 V DC, 150 W

Intended Use

The MicroAire REF 7500-700 Battery Charger is intended to charge all MicroAire 14.4 volt NiMH battery packs.

Introduction

This manual was written to help describe the procedures required to keep the MicroAire Battery Charger system

operating properly. Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and

NOTE carry special meanings and should be carefully reviewed.

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WARNING: Used to indicate that the safety of the patient and hospital personnel could be involved.

CAUTION: Used to indicate special procedures or precautions that must be followed to avoid damaging the

system and instruments.

NOTE: Used to indicate the easiest means of carrying out techniques.

General Warnings:

WARNING: Risk of re. Replace fuse with T5A/250V.

WARNING: Risk of re. Replace battery pack only with a MicroAire REF 6640-710 Battery Pack, REF 7505-710 or

REF 7500-620 Aseptic Battery Pack. Always use the REF 7500-625 Charger Adapter for the Aseptic Pack.

WARNING: Explosion hazard. Not suitable for use in the presence of ammable anesthetics or oxygen.

WARNING: Electric shock. Do not remove cover. Refer servicing to authorized MicroAire personnel only.

WARNING: Main disconnect must be achieved by removing cord from wall outlet.

WARNING: Use of the REF 7500-700 Battery Charger adjacent to or stacked with other equipment should

be avoided because it could result in improper operation. If such use is necessary, the REF 7500-700

Battery Charger and the adjacent equipment should be observed to verify that they are operating

normally.

WARNING: Use only with a medically approved Type SJT or equivalent three-wire grounded power cord rated for

125V or 250V AC, 10A, constructed with 18/3 AWG wires and an IEC 320 appliance connector and a

Hospital Grade outlet plug. The cord length shall not exceed 10ft (3.05m).

WARNING: Grounding reliability can only be achieved when the equipment is connected to an equipment

receptacle marked“Hospital Only”or “Hospital Grade”.

WARNING: No modication of this equipment is allowed.

WARNING: Prior to use system components should be inspected and operated to detect any damage or

malfunction. Do not use if damage is apparent.

WARNING: Medical electrical equipment may be aected by electromagnetic interference. It should be installed

and used in accordance with the electromagnetic compatibility information provided herein.

WARNING: Portable RF communications equipment should be used no closer than 30 cm (12 inches) away from

any part of the REF 7500-700 Battery Charger, the batteries being charged, or its power cable. Other

wise degradation of the performance of battery charger could result.

WARNING: Use with Battery Packs other than the REF 6640-710, REF 7505-710, or REF 7500-620 used with a

REF 7500-625 Charger Adapter could result in increased electromagnetic emissions or decreased

electromagnetic immunity, resulting in improper operation of the REF 7500-700 Battery Charger.

WARNING: The following items should be periodically inspected for signs of damage and repaired or replaced as

needed to ensure continued safety with regard to electromagnetic disturbances over the life of the

REF 7500-700 Battery Charger:

• Verify that all enclosure panels are securely fastened in place.

• Test that the Protective Earth Connection meets ES60601-1 Requirements.

WARNING: The REF 7500-700 Battery Charger is suitable for use in hospitals and surgery centers. The Battery

Charger should not be used near High Frequency Surgical equipment or Magnetic Resonance

Imaging equipment.

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CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician (or properly

licensed practitioner).

CAUTION: Do not autoclave.

CAUTION: Do not immerse in liquids to cool.

CAUTION: Do not ash sterilize.

CAUTION: Do not use Ethylene Oxide Sterilization.

CAUTION: Do not use a washer sterilizer.

CAUTION: Do not process in equipment using peracetic acid.

NOTE: The emissions characteristics of this product make it suitable for use in industrial areas and hospitals

(CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class Bis normally

required) this equipment might not offer adequate protection to radio frequency communication

services. The user might be required to take mitigation measures, such as relocating or re-orienting

the equipment.

NOTE: The Battery Charger is designed for use only with MicroAire Batteries REF 6640-710, REF 7505-710

and REF 7500-620 Aseptic Battery using a REF 7500-625 charger adapter.

NOTE: All personnel should become familiar with the power equipment before it is set-up for use in any

procedure. Personnel in-serviced should include, but not limited to, central processing personnel,

members of the surgical team, and the bioengineering department.

NOTE: DO NOT return equipment without an RMA number. Doing so could cause delays in service, and/or

problems tracking your equipment.outside the U.S. unless specied otherwise.

Name Ref#

(ISO 7000)2Symbol Description Use Standard

Refer to Instruction

Manual / Booklet

ISO-7010

M002

• Indicates a MANDATORY action for the user to consult the

Instructions For Use (IFU).

• Symbol must be blue, as shown.

IEC 60601-1:20051

Consult

Instructions For

Use (IFU)

1641

Indicates the need for the user to consult the Instructions For Use

(IFU). Not required in conjunction with the Caution

symbol, if applicable.

ISO 15223-1:20121

Caution

0434A /

0434B CIndicates the need for the user to consult the Instructions For Use

(IFU) for important cautionary information such as warnings and

precautions that cannot, for a variety of reasons, be presented on

the device itself.

ISO 15223-1:20121

UL symbol N/A

E494242

MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC SHOCK,

FIRE, AND MECHANICAL HAZARDS ONLY. IN ACCORDANCE WITH

ANSI/AAMI ES 60601-1 (2005) + A1 (2012) + CAN/CSA C22.2 No.

60601-1 (2014) | Control Number: E494242

Charge Complete

(Battery) N/A Indicates that charging of battery has completed. N/A

Charge Failed

(Battery) N/A Indicates that charging of battery has failed. N/A

Charging (Battery) N/A Indicates that charging of battery is in progress. N/A

REF (Catalog #) 2493

• Indicates the manufacturer’s catalog number so that the medical

device can be identied.

• Per EN980:2008, the REF symbol may be used without

surrounding box.

ISO 15223-1:20121

Non-Sterile 2609

• Indicates a medical device that has not been subjected to a

sterilization process. This symbol should only be used to

distinguish between identical or similar medical devices sold in

both sterile and non-sterile conditions.

• Also indicates a medical device that is provided non-sterile but

must be sterilized prior to use.

IEC 60601-1:20051

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Authorized

Representative

in the European

Community

N/A

Indicates the authorized representative in the European

Community. This symbol shall be accompanied by the name and

address of the authorized representative, adjacent to the symbol.

ISO 15223-1:20121

Serial # 2498

• Indicates the manufacturer’s serial number so that a specic

medical device can be identied.

• Per EN980:2008, the SN symbol may be used without

surrounding box.

ISO 15223-1:20121

Lot / Batch Code 2492 Indicates the manufacturer’s batch code so that the batch or lot

can be identied. ISO 15223-1:20121

Standby 5266 Indicates stand-by or preparatory state for a part of a piece of

equipment. IEC 60878:2015

Humidity Limita-

tion 2620

Indicates the range of humidity to which the medical device can be

safely exposed. The humidity limitations shall be indicated

adjacent to the upper and lower horizontal lines.

ISO 15223-1:20121

Atmospheric

Pressure

Limitation

2621

Indicates the range of atmospheric pressure to which the medical

device can be safely exposed. The atmospheric pressure

limitations shall be indicated adjacent to the upper and lower

horizontal lines.

ISO 15223-1:20121

Do Not Immerse in

any Liquid 5995 Indicates a medical device that is not to be immersed in any liquid. IEC 60335-2-15

Do Not Lubricate N/A Indicates a medical device that is not to be lubricated. N/A

Date of

Manufacture 2497

• Indicates the date when the medical device was

manufactured. The date is expressed as YYYY-MM (e.g. 2015-11)

or YYYY-MM-DD (e.g. 2015-11-29).

• If the symbol is lled (see Manufacturer symbol), both

the date of manufacture and the name/address of the

manufacturer may be combined in one symbol.

ISO 15223-1:20121

Manufacturer 3082

• Indicates the medical device manufacturer. This symbol shall be

accompanied by the name and address of the manufacturer. The

date of manufacture may be combined with this symbol.

• When using MicroAire as the manufacturer, use the MicroAire

LLC symbol.

ISO 15223-1:20121

CE Mark with NB N/A

2797

Indicates the European Conformity Mark with Notied Body

Number. 2797 is the BSI-NL-registered Notied Body.

Council Directive

93/42/EEC

Prescription N/A Caution: Federal Law (U.S.A.) restricts this device to sale by or on

the order of a physician (or properly licensed practitioner).

FDA Title 21,

Chapter 1,

Subchapter H,

Part 801.15(F)

Dispose of per

WEEE Directive

2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as

unsorted municipal waste. Medical device is to be disposed of per

WEEE Directive 2012/19/EU.

Council Directive

2012/19/EU

Dispose of per

WEEE Directive

2012/19/EU

N/A

Indicates a medical device that is not to be disposed of as

unsorted municipal waste. Medical device is to be disposed of per

WEEE Directive 2012/19/EU. This symbol is used in place of the

above symbol if the product entered the market after 13 August,

2005.

Council Directive

2012/19/EU

(Symbol: European

Standard EN 50419)

Packaging is

Recyclable 1135 Indicates that the marked item or its material is part of a recovery

or recycling process. IEC 60878:2015

1 ISO 15223-1:2012 – “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements”

2 ISO 7000/IEC 60417 – “Graphical symbols for use on equipment – Registered symbols”

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BATTERY CHARGER SETUP AND OPERATION

1. Plug in the Charger to a standard wall power supply.

All LED lights will turn on for 10 seconds, o ten seconds,

and on for ten seconds again, except for the Standby LED

in the center.

2. At the end of the LED test sequence, the single Green

Standby LED in the center will turn on to indicate that

the charger is ready. This light will remain on until the

charger is unplugged from the power source.

OPERATION

1. Verify that the“Standby” LED is on.

2. Insert a MicroAire REF 6640-710 or REF 7505-710 Battery into any slot. The battery can only be inserted into the

charger in one position.

3. If charging the REF 7500-620 Aseptic Battery, rst place the REF 7500-625 Charger Adapter into the charger. Then

place the REF 7500-620 into the REF 7500-625.

4. The“Charging” LED corresponding to that slot will blink until the battery is ready for fast charge. If the battery is

hot, or has a very low charge, the“Charging”LED may blink for some time. When fast charge begins the“

Charging” LED will be on continuously.

5. When the charging sequence is complete, the “Charge Complete”LED will illuminate.

6. The“Charge Failed” LED will illuminate if the battery takes too long to begin or complete fast charge. Remove and

re-insert the battery in a dierent slot to attempt charging again. If three consecutive“Charge Failed”

indications are received, the battery should be replaced.

WARNING: Prior to use, system components should be inspected and operated to detect any damage or

malfunction. Do not use if damage is apparent.

NOTE: The Battery Charger is designed for use only with MicroAire Batteries REF 6640-710, REF 7505-710

and REF 7500-620 Aseptic Battery using a REF 7500-625 charger adapter.

NOTE: All personnel should become familiar with the power equipment before it is set-up for use in any

procedure. Personnel in-serviced should include, but not limited to, central processing personnel,

members of the surgical team, and the bioengineering department.

Compatible Instruments

PRODUCT CATALOG NUMBER (REF) DESCRIPTION INSTRUCTIONS FOR USE WITH

COMPLETE LIST OF ACCESSORIES

REF 6640-710 Small NiMH Battery Pack IM-PWRBATT

REF 7505-710 Large NiMH Battery Pack IM-PWRBATT

REF 7500-620 Aseptic Battery Pack IM-ASEPBATT

REF 7500-625 Aseptic Battery Charger Adapter IM-ASEPBATT

Instruments and their accessories are sold separately. Contact your MicroAire® Sales representative or MicroAire® Customer Service

at 1-800-722-0822 for a complete list of accessories and instruments available. Outside the USA, contact your nearest MicroAire

authorized distributor.

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ENVIRONMENTAL PARAMETERS

OPERATING CONDITIONS

Devices have been tested and proven to operate within the following conditions:

Temperature Humidity Atmospheric

106kPa

50° F/10° C

86° F/30° C

15%

60%

70kPa

STORAGE CONDITIONS

Devices have been tested and proven to operate within the following conditions:

Temperature Humidity

0° F/-17° C

120° F/49° C

15%

90%

SHIPPING CONDITIONS

The REF 7500-700 may be shipped by any standard commercial method without special handling conditions.

CLEANING / DECONTAMINATION

1. Unplug charger from wall outlet prior to cleaning. External surfaces of the unit should be periodically wiped down

with a mild pH enzyme disinfectant. Charger should not be kept in patient vicinity.

CAUTION: Do not autoclave.

CAUTION: Do not immerse in liquids to cool.

CAUTION: Do not ash sterilize.

CAUTION: Do not use Ethylene Oxide Sterilization.

CAUTION: Do not use a washer sterilizer.

CAUTION: Do not process in equipment using peracetic acid.

TROUBLESHOOTING

If the unit fails to operate properly, check the following:

1. The unit is connected to a functional power outlet.

2. The Standby LED is on.

3. The unit is connected to an operational battery pack.

4. Check that ventilation holes at top and bottom of the unit are not obstructed.

If the Standby LED is o, it indicates that the charger is not ready for service. Unplug the charger, and plug it into a

functional power outlet. The test sequence described in the SETUP section should occur. The fans should run while

all the LED’s are on. If the charger feels warm to the touch, allow it to cool, then repeat SETUP test. If the Standby LED

does not illuminate at this time, contact MicroAire Customer Service for repair service.

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IN HOSPITAL INSPECTION

All MicroAire equipment should be inspected and tested periodically in accordance with the facility’s Bio-Engineering

policy. Such service should be documented within the Bio-Engineering Department.

MICROAIRE REPAIR SERVICE

Responsive service comes with every MicroAire® product. If a problem with your equipment should arise,

contact our Customer Service Department at:

Telephone: Fax: E-Mail:

USA 800-722-0822 800-648-4309 inquiry@microaire.com

Outside USA 434-975-8000 434-975-4134 intlsvc@microaire.com

MicroAire® may be able to solve the problem quickly without requiring return of the item for service. Do not

disassemble or attempt to service the equipment. It can only be serviced by MicroAire® or an Authorized MicroAire®

Repair Facility. Unauthorized service will void the warranty. MicroAire recommends that all equipment be

returned to the factory for routine inspection and service at least once a year. There is no charge for service during

the warranty period.

To return an item for service, contact MicroAire® Customer Service for a Return Material Authorization (RMA) number.

NOTE: DO NOT return equipment without an RMA number. Doing so could cause delays in service, and/or

problems tracking your equipment.outside the U.S. unless specied otherwise.

DISPOSAL/RECYCLE

Always follow the current local reccomendations and/or regulations governing environmental protection and the risks

associated with recycling or disposing of the equipment at the end of its useful life.

WARRANTY

MicroAire Surgical Instruments warrants its REF 7500-700 Battery Charger to be free from defects in material and

workmanship in their manufacture for a period of one year from the original purchase date by the end customer.

The warranty is limited to the repair or replacement of the product without charge.

This warranty is void in the event of abuse, misuse, or use in other than normal surgical environment, or in the event of

disassembly, alteration, or repair of the product not authorized by the manufacturer, or in the event that the product

has not been used in a reasonable manner and in compliance with the written instructions furnished by Manufacturer.

All other expressed or implied warranties of tness and merchantability are excluded here from, and manufacturer

shall have no liability of any kind for incidental or consequential damages.

Extended Warranty

An extended warranty is available on all MicroAire instruments. If the instrument is out of warranty, it must rst be

restored, if necessary, to full serviceable condition before being eligible for the extended warranty.

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WARNING:The REF 7500-700 Battery Charger is suitable for use in hospitals and surgery centers. The Battery

Charger should not be used near High Frequency Surgical Equipment or Magnetic Resonance

Imaging equipment.

NOTE: The emissions characteristics of this product make it suitable for use in industrial areas and hospitals

(CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class Bis normally

required) this equipment might not offer adequate protection to radio frequency communication

services. The user might be required to take mitigation measures, such as relocating or re-orienting

the equipment.

ELECTROMAGNETIC COMPATIBILITY

Guidance and manufacturer’s declaration –

power output, vibration exposure, noise emission value and mass weight information

Power Output

kW - KiloWatts

Vibration Exposure

ahv(m/s2) Uncertainty K (m/s2)

Noise Emission Value

LPA (dB(A)) LC,peak (dB(C)) LWA (dB(A)) Mass Weight (kg)

0.15 - - - - - 8.2

EMC Test and Standard Test Levels / Limits Compliance

Mains terminal disturbance voltage

(conducted emissions): CISPR 11 CISPR 11 Class A Complies with Class A Limits

Electromagnetic radiation disturbance

(radiated emissions): CISPR 11 CISPR 11 Class A Complies with Class A Limits

Harmonic distortion: IEC 61000-3-2 IEC 61000-3-2 Class A Complies with Class A Limits

Voltage uctuations and icker: IEC 61000-3-3 IEC 61000-3-3 Class A Complies with Class A Limits

Electrostatic discharge immunity:

IEC 61000-4-2

Discharge Level (kV)

Contact - Direct: +/- 6

Contact - Indirect: +/- 6

Air +/- 2, 4, 8

Complies Per Note *

Radiated RF electromagnetic eld immunity:

IEC 61000-4-3

3V/m

80MHz to 2700 MHz

80% AM at 1 KHz

Complies Per Note*

Immunity to proximity elds from RF wireless

communications equipment: IEC 61000-4-3 IEC 60601-1-2 Table 9 Complies Per Note*

Electrical fast transient/burst immunity -

IEC 61000-4-4

AC mains: +/- 2KV l00KHz Repetition Frequency Complies Per Note*

Surge Immunity: IEC 61000-4-5

Input Power Ports (Line to Line)

0.5kV and 1.0kV Combination Wave (2µs x

50µs Voltage, 8µs x 20µs Current) Complies Per Note*

(Line to Earth)

0.SkV, 1.0kV and 2.0kV

Combination Wave

(2µs x S0µs Voltage, 8µs x 20µs Current)

Complies Per Note*

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EMC Test and Standard Test Levels / Limits Compliance

Immunity to conducted disturbances induced

by RF elds (conducted RF disturbance

immunity)- a.c. mains: IEC 61000-4-6

Input AC Power Cord

Frequency range: lS0kHz to 80MHz

Level: 3 V outside the ISM band, 6 Vin the ISM

bands between 0.15 MHz and 80 MHz

Frequency step: 1%

Modulation: 80% Am at lkHz

Dwell Time: Minimum 1 s

Complies Per Note*

Power Frequency Magnetic Field Immunity:

IEC 61000-4-8 Frequency: 50 Hz or 60 Hz Test Level: 30 A/m Complies Per Note*

Voltage Dips: IEC 61000-4-11

Dip to 0V for 1 Cycle with 0 Degree Sync Angle.

Dip to 0V for 0.5 Cycles with Sync Angles of

0,45,90,135,180,225,270,315 degrees

Dip to 70% of 240V for 25 Cycles at 50Hz

Dip to 70% of 100V for 30 Cycles at 60Hz

Complies Per Note*

Voltage Interruptions Immunity:

IEC 61000-4-11

Dip to 0V for Sms. (250 Cycles at (S0Hz) or 300

Cycles at 60 Hz) Complies Per Note*

*NOTE: The 7500-700 Battery Charger has no Essential Performance as dened by ANSI/AAMI/ES60601-1. Compliance

with Immunity Testing is dened as: at least one charger output will remain functional after the test.

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