INSTRUCTIONS FOR USE (IFU)
MB1000 BATTERY PACK
1002-00-102
Rx ONLY
English (EN)
1 — English
TABLE OF CONTENTS
INTRODUCTION ..................................................................................................................................................................... 3
GENERAL PRODUCT INFORMATION ................................................................................................................................. 4
HOW SUPPLIED ................................................................................................................................................................. 4
DEVICE DESCRIPTION ..................................................................................................................................................... 4
INTENDED USE.................................................................................................................................................................. 4
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS .................................................................................................... 4
PERMITTED APPLICATIONS ............................................................................................................................................ 4
SYMBOLS GLOSSARY ......................................................................................................................................................... 5
SIGNAL WORDS .................................................................................................................................................................... 5
GENERAL SAFETY INFORMATION ..................................................................................................................................... 6
SAFETY INSTRUCTIONS .................................................................................................................................................. 6
PRODUCT FEATURES AND SPECIFICATIONS .................................................................................................................. 7
PRODUCT FEATURES ...................................................................................................................................................... 7
PRODUCT SPECIFICATIONS ........................................................................................................................................... 7
ENVIRONMENTAL CONDITIONS ......................................................................................................................................... 7
OPERATING INSTRUCTIONS ............................................................................................................................................... 9
SAFETY INSTRUCTIONS .................................................................................................................................................. 9
MC1000 4-PORT BATTERY CHARGER ATTACHMENT & REMOVAL .......................................................................... 10
ME1000 SURGICAL IMPACTOR ATTACHMENT & REMOVAL ..................................................................................... 10
CLEANING ............................................................................................................................................................................ 11
SAFETY INSTRUCTIONS ................................................................................................................................................ 11
POINT OF USE INSTRUCTIONS ..................................................................................................................................... 13
CONTAINMENT INSTRUCTIONS .................................................................................................................................... 14
MANUAL CLEANING INSTRUCTIONS ............................................................................................................................ 16
INSPECTION & FUNCTIONAL TESTING ........................................................................................................................... 19
SAFETY INSTRUCTIONS ................................................................................................................................................ 19
PACKAGING ........................................................................................................................................................................ 21
SAFETY INSTRUCTIONS ................................................................................................................................................ 21
PACKAGING METHODS .................................................................................................................................................. 22
PACKAGING INSTRUCTIONS ......................................................................................................................................... 22
STERILIZATION ................................................................................................................................................................... 25
SAFETY INSTRUCTIONS ................................................................................................................................................ 25
STERILIZATION INSTRUCTIONS ................................................................................................................................... 26
STORAGE AND HANDLING................................................................................................................................................ 27
SAFETY INSTRUCTIONS ................................................................................................................................................ 27
TROUBLESHOOTING.......................................................................................................................................................... 27
MAINTENANCE AND REPAIR ............................................................................................................................................ 29
DISPOSAL AND RECYCLING ............................................................................................................................................. 30
ORDERING INFORMATION ................................................................................................................................................ 31
2 — English
INTRODUCTION
These Instructions for Use are intended to provide:
• Detailed instructions for safe, effective, and proper
operation, processing, and care for the MB1000
Battery Pack, referred to henceforth as the Battery
Pack, device, or product.
• Instructions for inspection and functional testing to
determine that the device is safe for reuse.
These Instructions for Use are intended for physicians,
trained medical personnel, in-service trainers,
biomedical equipment technicians, and central
supply/sterile processing technicians. Keep and consult
these Instructions for Use during the service life of
the product.
The information contained in these Instructions for Use
is accurate at time of distribution. Medical Enterprises
Distribution, referred henceforth as Medical Enterprises
or MED, reserves the right to make changes to the
product described in the document without notice and
without incorporating those changes to products already
sold. Released documents are available to view or print
at www.medistribution.com.
The MB1000 Battery Pack is part of the ME1000 Impact
System, which consists of the following products:
• ME1000 Surgical Impactor
• MB1000 Battery Pack
• MC1000 4-Port Battery Charger
• ME1000 Adapters
• Rigid Sterilization Containers and Trays
Only use the Battery Pack with devices specified in the
PERMITTED APPLICATIONS section of these
Instructions for Use.
MED recommends the use of the Case Medical
SteriTite® Sealed Container 4” for ME04 (ME04SC) and
the Medical Enterprises Dual Battery Tray (ME04T),
designed specifically to sterilize and store the Battery
Pack. No other Trays or Containers may be used. Other
rigid containers and trays may cause product damage or
have a negative impact on the cleaning and sterilization
results. The recommended Tray and Container are laser
etched with the words MEDICAL ENTERPRISES
DISTRIBUTION. Reference the PACKAGING section of
these Instructions for Use for further information.
The cleaning and sterilization instructions provided in these
Instructions for Use were validated as being capable of
preparing this product for use. It is the responsibility of the
health care facility to ensure that reprocessing is performed
using the appropriate equipment and materials, and that
designated personnel have been adequately trained in order to
achieve the proper result. Always verify the cleaning and
sterilization processes using your actual equipment and
designated personnel to ensure proper results are achieved.
The final responsibility for verification of sterilization
techniques lies directly with the healthcare facility. To
ensure the efficacy of health care facility processing, all
cycles and methods should be verified for different
sterilization chambers, packaging method(s), and/or
various loading configurations.
Under certain classifications of risk, the World Health
Organization (WHO), or local regulatory authorities
recommend special CJD (Creutzfeldt-Jakob Disease)
inactivation processing procedures. Consult WHO and
local regulations for further information.
MED recommends an alternative manual system to be readily
available during each use of the ME1000 Impact System.
The warranty for the Battery Pack is voided by damage
from any usage other than those recommended in these
Instruction for Use, including but not limited to:
• abnormal wear,
• improper use,
• use of unauthorized sterilization trays or containers,
• non-permitted applications,
• use of unauthorized cleaning processes or
sterilization cycles and methods,
• use of unauthorized cleaning agents or lubricants,
• improper storage or transport,
• failure to perform recommended inspection,
operation, and functional checks,
• unauthorized maintenance, modification, or
disassembly.
Further, MED shall assume no responsibility for damage
resulting from usage that deviates from these
Instructions for Use. For further information on the
warranty, contact your MED representative or MED
directly.
The following are trademarks or registered trademarks of
MED in the United States. ME®, ME1000®, Medical
Enterprises®, Medical Enterprises Distribution®, and
ME1000 Impact System™. All other trademarks, service
marks, registered trademarks, or registered service
marks are the property of their respective owners in the
United States and other countries.
3 — English
GENERAL PRODUCT INFORMATION
HOW SUPPLIED
The MB1000 Battery Pack is provided fully assembled, non-sterile, and at a low state of charge. The Battery Pack must
be cleaned, inspected, functional tested, fully charged and sterilized prior to first use. Any protective covers and films must
be completely removed before processing. Reference MC1000 4-Port Charger Instructions for Use for properly charging the
MB1000 Battery Pack.
Due to lithium battery shipping regulations, the Battery Pack is shipped at a low state of charge. The Battery Pack must
be properly cleaned and fully charged upon initial receipt. For complete cleaning and charging instructions, reference the
CLEANING and INSPECTION & FUNCTION TESTING sections of these Instructions for Use.
NOTE: If the Battery Pack is damaged, please contact your MED Representative for assistance.
DEVICE DESCRIPTION
The MB1000 Battery Pack is a reusable and rechargeable lithium-ion battery power source for the ME1000 Surgical
Impactor.
INTENDED USE
The MB1000 Battery Pack is the power source for the ME1000 Surgical Impactor.
The MB1000 Battery Pack is intended for patient use ONLY after careful consideration of the Instructions for Use. It is
designed for use by physicians and trained medical personnel ONLY.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS
The surgeon must evaluate if the ME1000 Impact System is appropriate for the intended procedure, based on the
designed capabilities of the ME1000 Impact System with regards to bone density, bone strength, bone size, surgical
approach, and anatomical situation.
Additionally, the manufacturer’s contraindications and use considerations for the surgical instrument or device which MED
has designated for use with the ME1000 Impact System, must be fully understood and considered prior to use.
The warnings and cautions contained within these Instructions for Use relate to the operation, processing, and care of the
MB1000 Battery Pack in addition to its use with permitted device applications.
PERMITTED APPLICATIONS
The MB1000 Battery Pack is to be used exclusively with specific devices. The only permitted devices to be connected to the
Battery Pack are provided in Table 1 below. For further information, contact your MED representative or MED directly.
Table 1 – The ONLY devices permitted for use with the MB1000 Battery Pack.
CHARGER
SURGICAL INSTRUMENT
MC1000 4-PORT BATTERY CHARGER
REF 1003-00-101
ME1000 SURGICAL IMPACTOR
REF 1000-00-101
4 — English
SYMBOLS GLOSSARY
The symbols located on the ME1000 Impact System devices or its labeling are provided and defined in this section. It is
recommended that each are studied and understood for proper interpretation.
SYMBOL
DEFINITION
SYMBOL
DEFINITION
Rx ONLY
Federal law
restricts this
device to sale
by or on the
order of a
licensed
healthcare
practitioner.
Caution
Consult
Instructions for
Use
Device is
classified as
type B against
electrical shock
and leakage
current.
Lock/Unlock
Manufacturer
Temperature
Limitation
Humidity
Limitation
Non-sterile
SYMBOL
UL Classified
Direct Current
Alternating
Current
W
Watts
V
Volt
Hz
Hertz
dB
Decibel
Ah
Ampere-hour
Wh
Watt-hour
Orientation
Atmospheric
Pressure
Limitation
Date of
Manufacture
PPE (Personal
Protective
Equipment)
BFP
UL Listed
This device
should be
disposed of in
accordance with
environmental
protection
requirements.
Back Feed
Protection
Double
Insulation
Catalog number
Serial Number
DEFINITION
IPX6
I/O
Ingress
Protection
Rating
ON/OFF
SIGNAL WORDS
The signal words located on the ME1000 Impact System devices or its labeling are provided and defined in this section. It is
recommended that each are studied and understood for proper interpretation.
STATEMENT
WARNING
MEANING
Identifies a safety-related issue. ALWAYS comply with this information to prevent patient and/or
healthcare worker injury.
CAUTION
Identifies a product reliability issue. ALWAYS comply with this information to prevent product
damage.
NOTE
Supplements and/or clarifies procedural information.
5 — English
GENERAL SAFETY INFORMATION
SAFETY INSTRUCTIONS
WARNINGS:
CALIFORNIA PROPOSITION 65
• Before using the Battery Pack, READ, and
•
•
•
•
•
•
•
•
•
•
UNDERSTAND all instructions contained in these
Instructions for Use. Pay particular attention to safety
information. Failure to comply with these instructions may
result in electric shock, fire and/or injury.
Before using the Battery Pack with other MED compatible
products, READ and UNDERSTAND the Instructions for
Use provided with each product to be used. Pay particular
attention to safety information. Failure to comply with those
instructions may result in electric shock, fire and/or injury.
Risk of fire, explosion, and burns. DO NOT open, crush,
shred, heat above 138° C, short-circuit, or incinerate the
Battery Pack.
DO NOT modify or disassemble the Battery Pack.
Modification or disassembly is considered misuse and
could result in injury.
DO NOT expose the Battery Pack to conditions in excess
of the limitations indicated in the ENVIRONMENTAL
CONDITIONS section of these Instructions for Use.
The Battery Pack must be cleaned, inspected, functional
tested, fully charged, and sterilized prior to first use and
after every subsequent use as indicated in these
Instructions for Use. Any protective covers and films must
be completely removed before reprocessing.
Unless otherwise indicated, ONLY use the recommended
packaging as indicated in the PACKAGING section of
these Instructions for Use for the storage, sterilization, and
transportation of the Battery Pack. The use of other
packaging may lead to extended cleaning times,
inadequate sterilization, and product damage.
DO NOT use the Battery Pack if it has been dropped and
appears damaged or is not functioning properly. Contact
your MED Representative for disposition and replacement.
DO NOT use or charge the MB1000 Battery Pack if
damage, wear, corrosion, or missing parts are apparent or
the inspection and functional testing criteria are not met.
Contact your MED Representative for disposition and
replacement.
In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
ONLY use Battery Packs with MED permitted devices as
indicated in the PERMITTED APPLICATIONS section of
these Instructions for Use. Use with other devices is
considered improper use and may result in injury and/or
damage to the device or its attachments.
6 — English
WARNING: This product may contain
chemicals, including lead, known to
the State of California to cause
cancer, birth defects or other
reproductive harm. Wash hands
after handling.
CAUTION: ALWAYS handle the Battery Pack with care
to prevent product damage. DO NOT drop the Battery
Pack.
PRODUCT FEATURES AND SPECIFICATIONS
PRODUCT FEATURES
See Figure 1
The safe use of the Battery Pack requires an understanding of the information in these Instructions for Use as well as
knowledge of the procedure to be performed. Before use of this product, familiarize yourself with all operating features and
safety instructions.
RAISED RIB: Design feature allowing proper electrical connection to the ME1000 Surgical Impactor or MC1000 4-Port
Battery Charger.
TERMINALS: Electrical interface for the ME1000 Surgical Impactor or MC1000 4-Port Battery Charger.
Fig. 1
PRODUCT SPECIFICATIONS
Weight ........................................................................................................................................................... 1.2 lbs. (0.55 kg)
Voltage ....................................................................................................................................................................... 18 V DC
Type ....................................................................................................................................................................... Lithium-Ion
Capacity ................................................................................................................................................................ 1Ah, 18 Wh
Charging Time ...................................................................................... Charge time is approximately 1 hour for a full charge
Battery Pack Life ....................................................................................................................................... 100 Charge Cycles
PRODUCT IDENTIFICATION AND SAFETY INFORMATION
The product label is located on the bottom of the Battery Pack and contains product identification and safety information.
Reference this label for product name, catalog number, serial number, operational ratings, and important safety
information.
ENVIRONMENTAL CONDITIONS
7 — English
USE
TRANSPORTATION
40°C
104°F
STORAGE
60°C
140°F
Temperature
40°C
104°F
for max. 72 h
10°C
50°F
–29°C
–20°F
10°C
50°F
90%
90%
90%
Relative
Humidity
30%
10%
30%
1060 hPa
1060 hPa
1060 hPa
Atmospheric
Pressure
506 hPa
Altitude
506 hPa
-1,300 – 18,000 ft.
506 hPa
—
-1,300 – 18,000 ft.
NOTE: Transportation conditions were tested according to ASTM D4169-16
Maximum Temperature Limitation: 138° C (280° F)
• WARNING: Following sterilization, allow the Battery Pack to cool for at least one (1) hour before use.
NOTES:
• The Battery Pack will not operate when its internal temperature is above 70° C (158° F). Operation will automatically
resume once the device cools.
Battery Charging Conditions: Charge the MB1000 Battery Pack according to the USE temperature values indicated
above.
8 — English
OPERATING INSTRUCTIONS
SAFETY INSTRUCTIONS
WARNINGS:
• Risk of fire, explosion, and burns. DO NOT open, crush,
•
•
•
•
•
•
•
•
•
•
•
•
•
• Normally, one fully charged Battery Pack has sufficient
shred, heat above 138° C, short-circuit, or incinerate the
Battery Pack.
DO NOT modify or disassemble the Battery Pack.
Modification or disassembly is considered misuse and could
result in injury.
ALWAYS avoid contacting the Battery Pack Terminals with
metal objects. Contacting the Terminals with metal objects
such as rings and other jewelry could result in a burn injury,
fire and/or product damage.
The Battery Pack must be cleaned, inspected, functional
tested, fully charged, and sterilized prior to first use and after
every subsequent use as indicated in these Instructions for
Use. Any protective covers and films must be completely
removed before reprocessing.
ALWAYS remove the MB1000 Battery Pack from the
ME1000 Surgical Impactor before attaching or removing
ME1000 Adapters (including surgical instruments or other
devices designated for use with the Adapters), processing,
lubricating and/or performing inspection. Removing the
MB1000 Battery Pack will prevent unexpected operation that
could cause injury. Reference the ME1000 Surgical
Impactor Instructions for Use for Battery Pack removal
instructions.
Following sterilization, allow the Battery Pack to cool for at
least 1 hour before use.
ONLY use the Battery Pack for its intended use.
DO NOT use the Battery Pack if it has been dropped and
appears damaged or is not functioning properly. Contact your
MED Representative for disposition and replacement.
DO NOT use or charge the MB1000 Battery Pack if damage,
wear, corrosion, or missing parts are apparent or the
inspection and functional testing criteria are not met. Contact
your MED Representative for disposition and replacement.
In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case of
contact, wash the affected area with copious amounts of
water and seek medical advice.
MED recommends an alternative manual system to be readily
available during each use of the ME1000 Impact System.
ONLY use Battery Packs with MED permitted devices as
indicated in the PERMITTED APPLICATIONS section of
these Instructions for Use. Use with other devices is
considered improper use and may result in injury and/or
damage to the device or its attachments.
MED recommends ONLY using MB1000 Battery Packs that
have been charged within the last 30 days.
Immediate-use steam sterilization is NOT recommended for
the MB1000 Battery Pack.
capacity for an entire operation. As a precaution, it is
recommended that a second fully charged and sterilized
Battery Pack is readily available for use so that it can be
quickly exchanged under sterile conditions during the surgical
procedure, if necessary.
• To avoid injury, DO NOT use a Defective Battery Pack.
Defective Battery Packs are identified by following the
Inspection and Functional Testing instructions of these
Instructions for Use.
• When handling the Battery Pack,
ALWAYS use personal protective
equipment (PPE) including safety goggles
as recommended by the healthcare facility guidelines and
cleaning agent Safety Data Sheets (SDS).
• DO NOT allow petroleum-based products, penetrating
oils, solvents, lubricants, or other chemicals to come in
contact with the Battery Pack. These chemicals can
lead to inadequate sterilization and/or damage, weaken,
or destroy device parts that may result in injury.
•
•
•
•
•
•
CAUTIONS:
Upon receipt of initial purchase, the Battery Pack must be
cleaned and fully charged prior to storage.
Remove Battery Packs from the MC1000 4-Port Battery
Charger upon receiving a full charge. DO NOT leave fully
charged Battery Packs on the Charger for prolonged time
periods.
ALWAYS handle the Battery Pack with care to prevent
product damage. DO NOT drop the Battery Pack.
ALWAYS follow the recommended operating conditions
when using or charging the Battery Pack. Reference
the ENVIRONMENTAL CONDITIONS section of these
Instructions for Use.
DO NOT use tools to remove ME1000 Impact System
permitted devices or to operate ME1000 Impact System
movable parts (e.g. locks, latches, etc.)
To prevent over-discharge, ALWAYS remove the
Battery Pack from the ME1000 Surgical Impactor
following use.
NOTES:
• The user of the Battery Pack is responsible for its
proper use during surgery.
• The Battery Pack is intended for patient use ONLY after
careful consideration of these Instructions for Use.
• The Battery Pack is designed for use by physicians and
trained medical personnel ONLY.
• Battery Packs should be used in the date order in which
they were sterilized.
9 — English
MC1000 4-PORT BATTERY CHARGER ATTACHMENT & REMOVAL
The Battery Pack must be properly cleaned and inspected prior to being inserted into the MC1000 4-Port Battery Charger.
Reference the CLEANING and INSPECTION AND FUNCTIONAL TESTING sections of these Instructions for Use.
For complete instructions regarding Battery Pack use with the MC1000 4-Port Charger, reference the MC1000 4-Port
Charger Instructions for Use.
ME1000 SURGICAL IMPACTOR ATTACHMENT & REMOVAL
For complete instructions regarding Battery Pack use with the ME1000 Surgical Impactor, reference the ME1000 Surgical
Impactor Instructions for Use.
10 — English
CLEANING
SAFETY INSTRUCTIONS
WARNINGS:
• Risk of fire, explosion, and burns. DO NOT open, crush,
•
•
•
•
•
•
•
•
• In the event of Battery Pack leakage, DO NOT allow the
shred, heat above 138° C, short-circuit, or incinerate the
Battery Pack.
The Battery Pack must be cleaned, inspected, functional
tested, fully charged, and sterilized prior to first use and
after every subsequent use as indicated in these
Instructions for Use. Any protective covers and films must
be completely removed before reprocessing.
Failure to properly clean instruments prior to sterilization
may lead to inadequate sterilization. Surgical instruments
are used with or on patients who may harbor both
recognized and unrecognized infections. To prevent the
spread of infection, all reusable instruments must be
thoroughly cleaned and sterilized prior to initial use and
after each patient use. Instruments may have sharp edges
or features. Users and reprocessors must be cautious
when handling instruments.
ONLY clean the Battery Pack using the validated cleaning
instructions indicated in these Instructions for Use. Using
other cleaning methods may lead to inadequate cleaning,
sterilization and/or product damage.
ONLY individuals trained and experienced in the
processing of reusable medical devices should clean the
Battery Pack.
Brushes and other cleaning tools should either be
single-use disposable items or, if reusable,
decontaminated prior to use. Contaminants could
otherwise be transferred from one device to the next
during cleaning and pose health risks to healthcare
workers.
ALWAYS make sure the detergent solution is
completely rinsed from the Battery Pack before drying
the device.
DO NOT allow petroleum-based products,
penetrating oils, solvents, lubricants, or other
chemicals to come in contact with the Battery Pack.
These chemicals can lead to inadequate sterilization
and/or damage, weaken, or destroy device parts that
may result in injury.
ALWAYS remove the MB1000 Battery Pack from the
ME1000 Surgical Impactor before attaching or removing
ME1000 Adapters (including surgical instruments or other
devices designated for use with the Adapters), processing,
lubricating and/or performing inspection. Removing the
Battery Pack will prevent unexpected operation that could
cause injury. Reference the ME1000 Surgical Impactor
Instructions for Use for Battery Pack removal instructions.
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
• When handling the Battery Pack,
ALWAYS use personal protective
equipment (PPE) including safety goggles
as recommended by the healthcare facility guidelines
and cleaning agent SDS.
CAUTIONS:
• To avoid physical damage with other equipment, ONLY
•
•
•
•
•
•
•
•
•
•
•
11 — English
transport the Battery Pack in its recommended packaging.
Reference the PACKAGING section of these Instructions
for Use.
DO NOT allow soil to dry on the Battery Packs. Maintain
moisture on the devices as indicated in these Instructions
for Use to prevent drying and facilitate cleaning.
DO NOT use pressurized water as this may cause
damage to the Battery Pack.
DO NOT immerse the Battery Pack or allow liquid to soak
into terminals or openings. During cleaning, the device and
its Terminals may be placed under running water to
thoroughly rinse all surfaces.
MED recommends the Battery Pack to be cleaned using
fresh detergent solution.
Detergents with a pH of 7.5–8.5 are recommended,
higher or lower pH values can cause damage to Battery
Pack materials.
ALWAYS prepare detergent solution according to the
detergent manufacturer’s recommendations.
ALWAYS handle the Battery Pack with care to
prevent product damage. DO NOT drop the Battery
Pack.
DO NOT use sharp, hard, abrasive, pointed or metal
cleaning aids (e.g. pipe cleaning, wire bristle brushes, etc.)
to clean the Battery Pack.
DO NOT bend the Battery Pack terminals during
cleaning.
DO NOT use automated or ultrasonic equipment to
clean the Battery Pack.
DO NOT use tools to remove ME1000 Impact System
permitted devices or to operate ME1000 Impact System
movable parts (e.g. locks, latches, etc.).
NOTES:
• The cleaning and sterilization instructions provided in
these Instructions for Use were validated as being
capable of preparing this product for use. It is the
responsibility of the health care facility to ensure that
reprocessing is performed using the appropriate
equipment and materials, and that designated
personnel have been adequately trained in order to
achieve the proper result. ALWAYS verify the cleaning
and sterilization processes using your actual equipment
and designated personnel to ensure proper results are
achieved.
• The cleaning instructions in these Instructions for Use
apply ONLY to the MB1000 Battery Pack.
• Repeated processing according to these Instructions for
Use has minimal effect on and should not compromise the
performance or service life of the Battery Pack.
• MED used the following cleaning agents during validation
of the manual cleaning instructions. These cleaning agents
are not listed in preference to other available cleaning
agents which may perform satisfactorily.
Type: Neutral pH Enzymatic Detergent
Product Name: EmPower® Dual Enzymatic
Detergent
Product Catalog Number: 10-4100
• Detergents used on the MB1000 Battery Pack will be in
contact with the following product materials:
 Gold and Plastic
12 — English
POINT OF USE INSTRUCTIONS
Recommended Point of Use Supplies for Battery Packs:
• Soft lint-free cloth(s)
• Tap water
Point of Use Steps for Battery Pack:
See Figure 2
WARNING: ALWAYS remove the MB1000 Battery
Pack from the ME1000 Surgical Impactor before
attaching or removing ME1000 Adapters (including
surgical instruments or other devices permitted for use
with the Adapters), processing, lubricating and/or
performing inspection. Removing the Battery Pack will
prevent unexpected operation that could cause injury.
Reference the ME1000 Surgical Impactor Instructions for
Use for Battery Pack removal instructions.
1. Remove the Battery Pack from the ME1000
Surgical Impactor, if attached.
Fig. 2
2. Wipe the device using a clean soft lint-free cloth
dampened tap water to remove gross soil and
debris. See Fig. 2.
13 — English
CONTAINMENT INSTRUCTIONS
Recommended Containment Supplies & Devices
for Battery Packs:
•
•
•
•
Soft lint-free cloth(s)
Tap water
SteriTite Sealed Container 4” for ME04 (ME04SC)
Medical Enterprises Dual Battery Tray (ME04T)
Fig. 3
Containment Steps for Battery Pack:
See Figures 3-6
• WARNING: ONLY load the Medical Enterprises Dual
Battery Tray (ME04T) according to its specified load
plan located in the PACKAGING section of these
Instructions for Use.
1. Load each Battery Pack into the brackets of its
designated tray. See Fig. 3 and Table 2 (pg. 24)
 Position the Battery Pack with the terminals facing
down. See Fig. 3.
2. Place the loaded Tray into its designated
Container. See Fig. 4.
3. Cover the Battery Packs with clean soft lint-free
cloths(s) dampened with tap water to prevent
drying of soil and debris on the devices prior to
cleaning. See Fig. 5.
Fig. 4
4. Place the Container Lid over the Container and
latch securely for transport. See Fig. 6.
5. It is recommended that the Battery Pack is
reprocessed as soon as is reasonably practical
following each use.
Fig. 5
Fig. 6
14 — English
PREPARATION FOR CLEANING INSTRUCTIONS
Preparation for Cleaning Steps for Battery Pack:
See Figure 7
NOTES:
• Reference the POINT OF USE section of these
Instructions for Use for the removal of any attached
devices.
• Reference the OPERATING INSTRUCTIONS section
of the ME1000 Surgical Impactor Instructions for Use
for properly removing the Battery Pack from the
ME1000 Surgical Impactor.
1. Remove the Lid from the Container. See Fig. 7.
2. Remove the Battery Packs from the Tray.
3. Clean the SteriTite Sealed Container 4” for ME04
(ME04SC) and the Medical Enterprises Dual Battery
Tray (ME04T) according to the Case Medical
SteriTite Instructions for Use provided with those
devices.
15 — English
Fig. 7
MANUAL CLEANING INSTRUCTIONS
Recommended Containment Supplies & Devices for Battery Packs:
•
•
•
•
•
•
•
•
Neutral pH Enzymatic Detergent (pH of 7.5–8.5)
Soft lint-free cloth(s)
Lint-free absorbent cloth
Various sized soft bristle nylon brushes
Syringe
Tap Water
De-ionized (DI) water
Filtered pressurized compressed air (20 psi)
Manual Cleaning Steps for Battery Pack:
See Figures 8-17
CAUTIONS:
• DO NOT immerse the Battery Pack or allow liquid to soak
into terminals or openings. During cleaning, the device and
its Terminals may be placed under running water to
thoroughly rinse all surfaces.
• DO NOT bend the Battery Pack terminals during
cleaning.
Fig. 8
1. Rinse the device for at least three (3) minutes under
cool running tap water. Use a clean soft lint-free
cloth, soft bristle nylon brush or syringe filled with
tap water to assist in removing gross soil from the
device. See Fig. 8.
2. Prepare a fresh batch of neutral pH enzymatic
detergent solution according to the detergent
manufacturer’s written instructions.
Fig. 9
3. Using a soft bristled nylon brush soaked with
detergent solution, brush the device for at least
five (5) minutes to remove visible soil. See Fig’s.
9,10.
Fig. 10
16 — English
4. Rinse the device thoroughly under lukewarm
running tap water for at least two (2) minutes to
remove all traces of detergent solution. See Fig’s.
11,12.
 Use a syringe filled with tap water to flush any hardto-reach areas. See Fig. 12.
5. Visually inspect the device remaining soil. If soil
is observed, repeat steps 1-5 using new brush and
a fresh batch of detergent solution.
 Pay close attention to crevices, grooves, and any
hard to reach areas. See Fig. 13.
NOTE: De-ionized (DI) water is recommended for the
final rinse of the Battery Pack. Mineral residues from
hard water can stain the device and/or prevent effective
cleaning.
Fig. 11
6. Rinse the device thoroughly under de-ionized (DI)
water for at least two (2) minutes. See Fig’s. 14,15.
 Use a syringe filled with de-ionized (DI) water to
flush any hard-to-reach areas. See Fig. 15.
Fig. 12
Fig. 13
De-ionized (DI) Water Rinse
Fig. 14
De-ionized (DI) Water Rinse
Fig. 15
17 — English
7. Positon the device on a clean absorbent lint-free
cloth with the Terminals oriented downwards to
assist in drainage. Allow the device to drain for at
least two (2) minutes. See Fig.16.
8. Dry the device using a clean soft lint-free cloth or
filtered pressurized compressed air. See Fig. 17.
 Pay close attention to crevices, grooves, and any
hard-to-reach areas where moisture can
accumulate. See Fig. 13.
Fig. 16
Fig. 17
18 — English
INSPECTION & FUNCTIONAL TESTING
SAFETY INSTRUCTIONS
WARNINGS:
• Risk of fire, explosion, and burns. DO NOT open, crush,
•
•
•
•
•
•
•
•
•
•
•
•
• ALWAYS make sure the Battery Pack has been properly
shred, heat above 138° C, short-circuit, or incinerate the
Battery Pack.
DO NOT modify or disassemble the Battery Pack.
Modification or disassembly is considered misuse and
could result in injury.
The Battery Pack must be cleaned, inspected, functional
tested, fully charged, and sterilized prior to first use and
after every subsequent use as indicated in these
Instructions for Use. Any protective covers and films must
be completely removed before reprocessing.
ONLY use the Battery Pack for its intended use.
DO NOT use the Battery Pack if it has been dropped and
appears damaged or is not functioning properly. Contact
your MED Representative for disposition and replacement.
DO NOT use or charge the MB1000 Battery Pack if
damage, wear, corrosion, or missing parts are apparent or
the inspection and functional testing criteria are not met.
Contact your MED Representative for disposition and
replacement.
In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
ONLY use the Battery Pack with the MC1000 4-Port
Battery Charger and ME1000 Surgical Impactor as
indicated in the PERMITTED USE section of these
Instructions for Use. Use with other equipment may result
in injury and/or product damage.
ONLY use clean and dry Battery Packs with the MC1000
4-Port Battery Charger.
To avoid injury, DO NOT process a Defective Battery
Pack for use. Defective Battery Packs are identified
by following the Inspection and Functional Testing
instructions of these Instructions for Use.
ALWAYS avoid contacting the Battery Pack Terminals with
metal objects. Contacting the Terminals with metal objects
such as rings and other jewelry could result in a burn injury,
fire and/or product damage.
Following each cleaning, ALWAYS perform the
inspection and functional testing instructions as indicated
in these Instructions for Use. Failing to follow these
instructions will lead to damage and malfunction,
increasing the risk of injury.
ONLY individuals trained and experienced in the
maintenance of reusable medical devices should inspect
and test the Battery Pack.
cleaned, inspected, fully charged, functional tested and is
completely dry prior to sterile packaging.
• When handling the Battery Pack,
ALWAYS use personal protective
equipment (PPE) including safety goggles
as recommended by the healthcare facility guidelines
and cleaning agent SDS.
• DO NOT allow petroleum-based products,
penetrating oils, solvents, lubricants, or other
chemicals to come in contact with the Battery Pack.
These chemicals can lead to inadequate sterilization
and/or damage, weaken, or destroy device parts that
may result in injury.
CAUTIONS:
• ALWAYS handle the Battery Pack with care to
prevent product damage. DO NOT drop the Battery
Pack.
• ALWAYS follow the recommended operating
conditions when using or charging the Battery Pack.
Reference the ENVIRONMENTAL CONDITIONS
section of these Instructions for Use.
• DO NOT use tools to remove ME1000 Impact System
permitted devices or to operate ME1000 Impact System
movable parts (e.g. locks, latches, etc.).
NOTE: The routine inspection, functional testing and
charging as indicated in the following instructions, are
the best methods for ensuring the device is ready for
safe operation.
INSPECTION INSTRUCTIONS
19 — English
Inspection Steps for Battery Pack:
1. Visually inspect each cleaned Battery Pack 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, etc.)
 Wear: (e.g. corrosion, removed or illegible part
numbers, symbols, and markings, etc.)
2. If damage or wear is detected, contact your MED
Representative for disposition and replacement.
DO NOT process a Battery Pack with damage or
wear for reuse.
3. If no damage or wear is detected, immediately
proceed to the functional testing instructions
below.
FUNCTIONAL TESTING INSTRUCTIONS
Functional Testing Steps for Battery Pack:
The function of each Battery Pack is tested during the charge cycle while connected to the MC1000 4-Port Battery Charger.
• WARNING: ONLY use clean and dry Battery Packs with
the MC1000 4-Port Battery Charger.
1. Fully charge the Battery Pack as indicated in the
BATTERY PACK CHARGING INSTRUCTIONS
section of the MC1000 4-Port Battery Charger
Instructions for Use.
20 — English
PACKAGING
SAFETY INSTRUCTIONS
CAUTION:ALWAYS handle the Battery Pack with
care to prevent product damage. DO NOT drop the
Battery Pack.
WARNINGS:
• Unless otherwise indicated, ONLY use the recommended
•
•
•
•
•
•
•
packaging as indicated in the PACKAGING section of
these Instructions for Use for the storage, sterilization, and
transportation of the Battery Pack. The use of other
packaging may lead to extended cleaning times,
inadequate sterilization, and product damage.
DO NOT process the MB1000 Battery Pack for use if
damage, wear, or corrosion are apparent or the inspection
and functional testing criteria are not met. Contact your
MED Representative for disposition and replacement.
In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
When handling the Battery Pack,
ALWAYS use personal protective
equipment (PPE) including safety goggles
as recommended by the healthcare facility guidelines
and cleaning agent SDS.
ALWAYS make sure the Battery Pack has been properly
cleaned, inspected, charged, functional tested and is
completely dry prior to sterile packaging.
ONLY Trays and Containers manufactured for, distributed
by, and/or designated by MED shall be used for the storage
and sterilization of the ME1000 Surgical Impactor as
indicated in the PACKAGING section of these Instructions
for Use. Use of other containment devices are not
recommended and may lead to extended cleaning
times, inadequate sterilization, and/or device
damage.
For Preconfigured Tray and Container layouts, areas
designated for specific devices shall contain ONLY the
devices as indicated in the MED load plan(s) and
packaging instructions for the specified Tray or Container.
Overcrowding and/or incorrect loading can result in device
damage and/or negatively impact the effectiveness of
cleaning and sterilization.
ONLY load the Medical Enterprises Dual Battery Tray
(ME04T) according to its specified load plan located in the
PACKAGING section of these Instructions for Use.
NOTE: The validated sterilization instructions provided in
these Instructions for Use are ONLY applicable to the product
configurations and packaging methods as indicated in the
PACKAGING section of these Instructions for Use.
21 — English
PACKAGING METHODS
The packaging method recommended for the sterilization, sterile storage, and transport of the MB1000 Battery Packs are provided in
the PACKAGING INSTRUCTIONS below. No other packaging method is recommended for use with these devices.
Packaging Method: SteriTite Sealed Container 4” for ME04 (ME04SC). See Figures 19,20.
NOTE: The SteriTite Sealed Container 4” for ME04 (ME04SC) is supplied with the Container Lid.
For non-sterile storage of the MB1000 Battery Packs, use the SteriTite Container with enclosed Medical Enterprises Dual
Battery Tray packaging method or if in good condition, the original product packaging or its equivalent.
PACKAGING INSTRUCTIONS
Recommended Packaging for Battery Pack:
• SteriTite Sealed Container 4” for ME04
REF: ME04SC
• SteriTite Filters Polypro 10"x4" 1000/pk.
REF: SCFM02
• Medical Enterprises Dual Battery Tray
REF: ME04T
NOTE: SteriTite Disposable Polypro filters are validated for
use in both Saturated Steam Forced Air Removal (PreVacuum) and STERRAD® 100NX® STANDARD Cycle
sterilization.
Packaging Steps for Battery Pack:
See Figures 18-22 and Tables 2,3
WARNINGS:
• ALWAYS make sure the Battery Pack has been properly
cleaned, inspected, charged, functional tested and is
completely dry prior to sterile packaging.
• ONLY load the Medical Enterprises Dual Battery Tray
(ME04T) according to its specified load plan located in the
PACKAGING section of these Instructions for Use.
NOTE: Reference the Case Medical SteriTite Instructions for
Use for the recommended use of disposable sterilization
accessories. (i.e. Chemical Indicators, Load Cards, Tamper
Evident Seals, etc.) with the SteriTite Sealed Container 4” for
ME04 (ME04SC) and the Medical Enterprises Dual Battery
Tray (ME04T).
1. Load clean and dry Battery Packs into the
brackets of its designated Tray.
 Load the Battery Pack with the terminals facing
down. See Fig. 18.
Fig. 18
22 — English
2. Place new filters into the filter housings located in
the Container base and Lid as indicated in the
Case Medical SteriTite Instructions for Use.
Container Base and Loaded Tray
3. Place the loaded Tray into the Container.
See Fig. 19.
Medical Enterprises Dual Battery
Tray (ME04T)
SteriTite Sealed Container
4” for ME04 (ME04SC)
Fig. 19
4. Place the Container lid over the Container and
latch securely. See Fig. 20.
Container Base, Lid, and Enclosed Tray
Lid for SteriTite Sealed Container
4” for ME04 (ME04SC)
Medical Enterprises Dual Battery
Tray (ME04T)
SteriTite Sealed Container
4” for ME04 (ME04SC)
Fig. 20
23 — English
NOTE: A circle symbol containing a numerical value is
provided to locate the items in Table 2 within Figure 22.
See Fig. 21.
ITEM NUMBER
1
Fig. 21
Table 2: Load Plan for Medical Enterprises Dual Battery Tray (ME04T)
ITEM
2
REF
PRODUCT DESCRIPTION
QTY
1
ME04T
MEDICAL ENTERPRISES DUAL BATTERY TRAY
1
2
1002-00-102
MB1000 BATTERY PACK
2
LOAD PLAN ILLUSTRATION FOR
MEDICAL ENTERPRISES DUAL BATTERY TRAY (ME04T)
1
2
2
Fig. 22
MB1000 BATTERY PACK
(1002-00-102)
Table 3: Load Dimensions for SteriTite Sealed Container 4” for ME04 (ME04SC) and Medical Enterprises
Dual Battery Tray (M0E4T).
REF
Product Description
Dimensions
ME04SC
STERITITE SEALED CONTAINER 4” FOR ME04
12” x 6” x 4” (30.5 x 15.24 x 10 cm)
ME04T
MEDICAL ENTERPRISES DUAL BATTERY TRAY
11.8” x 5.8” x 3” (30 x 14.7 x 7.6 cm)
24 — English
STERILIZATION
SAFETY INSTRUCTIONS
•
•
•
•
•
•
•
•
•
•
•
WARNINGS:
Risk of fire, explosion, and burns. DO NOT open, crush,
shred, heat above 138° C, short-circuit, or incinerate the
Battery Pack.
The Battery Pack must be cleaned, inspected, functional
tested, fully charged, and sterilized prior to first use and
after every subsequent use as indicated in these
Instructions for Use. Any protective covers and films must
be completely removed before reprocessing.
DO NOT use or charge the MB1000 Battery Pack if
damage, wear, corrosion, or missing parts are apparent or
the inspection and functional testing criteria are not met.
Contact your MED Representative for disposition and
replacement.
ALWAYS make sure the Battery Pack has been properly
cleaned, inspected, charged, functional tested and is
completely dry prior to sterilization.
ONLY sterilize the MB1000 Battery Pack using the
validated sterilization cycles indicated in these Instructions
for Use. Using other cycles may lead to inadequate
sterilization and/or product damage.
ONLY individuals trained and experienced in the
processing of reusable medical devices should sterilize the
Battery Pack.
ALWAYS follow the recommended Dry Time to achieve
proper sterilization and to prevent moisture accumulation.
Following sterilization, allow the Battery Pack to cool for at
least 1 hour before use.
In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
When handling the Battery Pack,
ALWAYS use personal protective
equipment (PPE) including safety goggles
as recommended by the healthcare facility guidelines
and cleaning agent SDS.
Immediate-use steam sterilization is NOT recommended
for the MB1000 Battery Pack.
CAUTIONS:
• DO NOT dry the Battery Pack in an oven. ONLY filtered
pressurized compressed air and/or clean soft lint-free cloth
are recommended for drying the Battery Pack.
• DO NOT expose the Battery Pack to conditions in
excess of the Sterilization Exposure Time and
Temperature indicated in these Instructions for Use.
• Exceeding recommended steam sterilization exposure
times or temperatures for the Battery Pack will reduce
Battery life, performance and/or damage the product.
NOTES:
• The cleaning and sterilization instructions provided in these
Instructions for Use were validated as being capable of
preparing this product for use. It is the responsibility of the
health care facility to ensure that reprocessing is performed
using the appropriate equipment and materials, and that
designated personnel have been adequately trained in
order to achieve the proper result. ALWAYS verify the
cleaning and sterilization processes using your actual
equipment and designated personnel to ensure proper
results are achieved.
• The final responsibility for verification of sterilization
techniques lies directly with the healthcare facility. To
ensure the efficacy of health care facility processing,
all cycles and methods should be verified for different
sterilization chambers, packaging methods, and/or
various loading configurations.
• Under certain classifications of risk, the World Health
Organization (WHO), or local regulatory authorities
recommend special CJD (Creutzfeldt-Jakob Disease)
inactivation processing procedures. Consult WHO
and local regulations for further information.
• The sterilization instructions provided in these
Instructions for Use apply ONLY to the MB1000
Battery Pack.
• Autoclave design and performance can affect the
sterilization process. ALWAYS verify the process using
your actual equipment and designated personnel.
• Repeated processing according to these Instructions for
Use has minimal effect on and should not compromise the
performance or service life of the Battery Pack.
25 — English
STERILIZATION INSTRUCTIONS
Sterilization Steps for Battery Pack:
NOTE: Prior to sterilization, make sure the Medical
Enterprises Dual Battery Tray (ME04T) is loaded according to
its load plan.
1. Place the loaded Container into the sterilizer
following load instructions specified in the
sterilizer manufacturer’s Instructions for Use.
2. Expose the load to one (1) of the validated
sterilization cycles shown in Table 4 below:
Table 4: Validated Sterilization Cycles
Cycle Type
Saturated Steam Forced Air
Removal (Pre-Vacuum)
STERRAD® 100NX®
STANDARD Cycle
Sterilization
Exposure
Time
4 minutes
Sterilization
Exposure
Temperature
Dry
Time
Packaging Method
132° C (270° F)
Minimum
20 min.
SteriTite Sealed Container 4” for
ME04 (ME04SC) and enclosed
Medical Enterprises Dual Battery
Tray (ME04T)
Follow sterilization instructions provided by
STERRAD. Contact STERRAD
representative for more information.
NOTE: Equipment compatible with
STERRAD systems is listed on the
STERRAD Sterility Guide (SSG) website.
3. The actual drying time may vary due to steam
quality, device materials, sterilizer performance,
etc. The sterilization container should not have
any visible moisture or dampness when dry.
4. Allow the load to cool prior to handling according
to guidance outlined in ANSI/AAMI ST79, Section
8.8.1, which states, “During cooling, the sterilizer
cart should be placed in a low-traffic area where
there are no air-conditioning or other cold-air
vents in close proximity. Warm items should
NEVER be transferred from the cart to cold metal
racks or shelves for cooling or placed within dust
covers before completion of the cooling process.”
5. Allow the Battery Pack to cool for at least one (1)
hour before use.
6. Following cooling, transfer the sterilized packages
to the appropriate storage location or point of use.
Transport sterilized products with care to prevent
damage to the sterile barrier. Avoid excessive
handling.
26 — English
SteriTite Sealed Container 4” for
ME04 (ME04SC) and enclosed
Medical Enterprises Dual Battery
Tray (ME04T)
STORAGE AND HANDLING
SAFETY INSTRUCTIONS
WARNINGS:
CAUTIONS:
• Unless otherwise indicated, ONLY use the recommended
packaging as indicated in the PACKAGING section of
these Instructions for Use for the storage, sterilization, and
transportation of the Battery Pack. The use of other
packaging may lead to extended cleaning times,
inadequate sterilization, and product damage.
• A fully charged Battery Pack in sterile storage must be
charged every 30 days to maintain a full state of charge.
• ALWAYS transport sterilized products with care to
prevent damage to the sterile barrier. Avoid excessive
handling.
• In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
• To prevent over-discharge, Battery Packs which have
•
•
•
•
been fully charged and placed in non-sterile storage,
should be fully recharged every 6 months.
To prevent over-discharge, ALWAYS remove the
Battery Pack from the ME1000 Surgical Impactor
following use.
ALWAYS follow the recommended storage conditions
when storing the Battery Pack. Reference the
ENVIRONMENTAL CONDITIONS section of these
Instructions for Use.
ALWAYS handle the Battery Pack with care to
prevent product damage. DO NOT drop the Battery
Pack.
ONLY store or transport the Battery Pack in its
recommended packaging. Reference the
PACKAGING section of these Instructions for Use.
STORAGE INSTRUCTIONS
Storage Steps for Battery Pack:
NOTES:
• ALWAYS store the Battery Pack at a full state of charge
for maximum battery life.
• For maximum shelf-life information, reference the Case
Medical SteriTite Instructions for Use.
1. Transport the sterile Container containing the
Battery Packs with care to prevent damaging the
sterile barrier. Avoid excessive handling.
2. Store the sterilized Battery Pack in a clean, dry,
and controlled environment protected from
temperature extremes, moisture, and direct
sunlight. Battery Packs should be used in the
date order in which they were sterilized.
TROUBLESHOOTING
27 — English
Troubleshooting Instruction for Battery Pack:
For problems relating to Battery Pack use with the ME1000 Surgical Impactor, reference the Surgical Impactor Instructions for Use. For
problems relating to Battery Pack use with MC1000 4-Port Battery Charger, reference the MC1000 4-Port Battery Charger Instructions
for Use.
For further technical support and product related questions, Contact your MED Representative.
ALWAYS have the product catalog number and serial number available when communicating with your MED
Representative and/or MED regarding your ME1000 Impact System products.
28 — English
MAINTENANCE AND REPAIR
WARNINGS:
• Risk of fire, explosion, and burns. DO NOT open, crush,
shred, heat above 138° C, short-circuit or incinerate the
Battery Pack.
• DO NOT modify or disassemble the Battery Pack.
Modification or disassembly is considered misuse and
could result in injury.
NOTE: Repeated processing according to these Instructions
for Use has minimal effect on and should not compromise the
performance of the MB1000 Battery Pack.
Maintenance and Repair Instruction for Battery Pack
For safety reasons, the Battery Pack cannot be serviced or repaired. Please refer to the DISPOSAL AND RECYCLING section within
these Instructions for Use for product disposition at the end of its service life.
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.
29 — English
DISPOSAL AND RECYCLING
WARNINGS:
• Risk of fire, explosion, and burns. DO NOT open, crush,
• ALWAYS follow the current local regulations governing
shred, heat above 138° C, short-circuit or incinerate the
Battery Pack.
• DO NOT expose the Battery Pack to conditions in excess
of the limitations indicated in the ENVIRONMENTAL
CONDITIONS section of these Instructions for Use.
• ALWAYS follow the current local recommendations and/or
regulations governing environmental protection and the
risks associated with recycling or disposing of batteries.
biohazard waste to safely handle and dispose of surgical
waste.
• ALWAYS follow the current regulations governing the
shipping of Lithium-Ion Batteries.
• In the event of Battery Pack leakage, DO NOT allow the
leaking fluid to come into contact with skin or eyes. In case
of contact, wash the affected area with copious amounts of
water and seek medical advice.
Disposal and Recycle Instructions for Battery Pack:
The MB1000 Battery Pack has been designed to provide maximum trouble-free life. However, like all products, it will
eventually wear out. DO NOT disassemble or attempt to repair the Battery Pack.
Contact your MED Representative or MED directly for disposition instructions for MED products at the end of their service life.
30 — English
ORDERING INFORMATION
For a current listing of all ME1000 Impact System products or for further information about our products, please visit our
website at: www.medistribution.com.
31 — English
Manufactured for:
Medical Enterprises Distribution, LLC
5875 Peachtree Industrial Boulevard
Suite 160
Norcross, GA 30092
1-800-207-0611
www.medistribution.com
991000586 REV 04 - 2017-04-20
32 — English
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