BRASSELER USA BSP MAX II User manual

PM-X12-700-IR-12.13
SURGICAL POWER & ACCESSORIES
Rx Only

3
able of Contents
ntroduction Page 4
ntended Use Page 4
Warnings Page 4
Cautions Page 6
Explanation of Symbols Page 7
Features Page 8
Battery Pack - nstallation & Removal Page 9
Saw Blade - nstallation & Removal Page 10
Handpiece Operation Page 11
Troubleshooting Page 12
Care and Maintenance Page 14
Cleaning Recommendations Page 15
Sterilization Recommendations Page 16
Specifications Page 18
Repair Service Page 24
Warranty Page 25
Return Goods Policy Page 26
Product Disposal Page 27
Product Ordering nformation Page 27

4
Thank you for choosing Brasseler USA® Surgical Power & Accessories as supplier of your large bone power system.
The information and procedures described in this manual are intended to assist medical professionals in
the safe and effective use, care, cleaning, sterilization and long-term maintenance of BSPMAX™ II Large
Bone Power System.
Introduction
The BSPMAX™ II handpieces are designed for surgical applications in: Orthopaedics, Total Joint Reconstruction,
Osteotomies, Trauma and Thoracic.
The BSPMAX™ II Sagittal/Oscillator Saw, PM-X12-700, is designed for cutting bone and bone related tissue
most common to large bone orthopaedic surgical procedures.
Intended Use
Warnings
• Only trained and experienced medical professionals
should use this equipment. Failure to comply with
the BSPMAX™ II Instructions for Use may result in
patient and/or medical staff injury.
• Use of eye protection is required while operating
equipment.
• To prevent accidental activation of the handpiece,
the trigger should always be in the SAFE mode
when attachment, battery pack and cutting
accessory (saw blade) are being installed or
removed.
• To ensure safety and optimum performance, use
Brasseler USA® Surgical Power & Accessories
cutting accessories (drills, wires and pins).
• Before each use, test the equipment and inspect
each device (handpiece and accessory) for damage.
Do not use any device if damage or malfunctioning is
apparent. Return device for service.
• Continually check handpiece for excessive heat. If
overheating is noticed, discontinue use and return
device for service.

5
• Clean and sterilize handpiece, battery packs and
accessories before every use.
• Perform recommended preventive maintenance
as indicated in the Care and Maintenance section.
• Do not sterilize 4-Bay Power Unit, Charging Bay
Cover and Charging Bay.
• DANGER - Explosion Hazard. DO NOT use in
atmospheres containing flammable gasses
(anesthetics, etc) with concentrations within
explosive limits.
• DO NOT expose battery packs to fire or incineration.
• DO NOT allow battery pack contacts to contact
metal objects. Contact with metal objects may
result in an electrical shock or a burn injury to the user.
• DO NOT install or remove saw blade while the
handpiece is operating. Always place the
handpiece in the SAFE mode while the handpiece
is idle, before installing or removing saw blade, or
when passing the handpiece to another person.
• DO NOT apply excessive force on a saw blade
when installed in the handpiece, such as bending
or prying. Using excessive force may damage the
device or saw blade and may cause injury to
patient and/or user.
• DO NOT reuse single use products. Failure to
comply may result in patient and/or health care
staff injury.
• Inspect saw blades for damage before each use.
Do not attempt to straighten or sharpen.
• Install and place the handpiece into service according
to the EMC information in this manual. Portable and
Mobile RF communications equipment can affect the
function of the handpiece.
• 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.
Warnings (continued)

• Handpieces are factory sealed. Do not disassemble
or lubricate handpieces, as this may void warranty.
There are no service requirements expected of the
medical or bio-med staff.
• DO NOT stall the handpiece, stalling may damage
electrical and/or mechanical components. If the
handpiece jams, release the trigger immediately
and remove any obstructions before continuing.
• DO NOT use handpieces or battery packs while
warm. Allow adequate time for cooling prior to
use. Do not immerse in liquid or cover handpiece
with a damp cloth to cool. Cool by exposure to
room temperature.
• DO NOT store battery packs on handpieces.
Batteries will discharge if they are connected to
the handpiece even though the handpiece is not
running or irreparable damage to battery pack may
occur.
• Handpiece with attachment and or accessory may
cause vibration and fatigue if duty cycle is
exceeded.
• Prior to each use, perform the following:
- Inspect all devices for proper set up and
operation.
- Ensure the battery pack installs properly onto the
handpiece.
- Ensure the saw blade installs properly.
- Ensure there are no loose or missing
components.
- Ensure there are no cracks in the battery pack
case.
- Remove the blade, then test the handpiece and
battery pack to ensure that they are working
properly.
- Check all moving parts for free movement.
- Check for unusual sounds or vibrations.
- Check for proper operating speed.
- Check for rapid temperature rise or unacceptable
heat with handpiece.
• After each use, perform the following:
- Remove battery pack from handpiece or
irreparable damage to battery pack may occur. If
battery is not removed, the charge will be
depleted and irreparable damage to battery cells
may occur.
- Thoroughly clean and disinfect all devices.
- Sterilize handpiece.
6
Cautions

7
Explanation of Symbols
Catalog number.
Caution.
Date of manufacture.
Do not discard. Dispose of product or recycle in accordance
with local laws and regulations.
Do not immerse.
h
Y
N
Interference.
Manufacturer.
Serial Number.
Steam sterilizable.
Temperature limit.
M
f
l

8
Features
Battery Pack Latch
Battery Pack
•Battery Pack - Rechargeable sterilizable battery pack provides power to the handpiece.
•Battery Pack Latch – Secures the battery pack to the handpiece. Depress the battery latch to release the
battery pack from the handpiece.
•Battery Receptacle – Battery pack connecting location.
•Blade Alignment Tabs – Alignment tabs that serve as a guide to position saw blade hub on the sagittal head.
•Blade Lock Button – Locking mechanism that retains saw blade securely on Sagittal Head.
•Sagittal Head – Open design for easier cleaning and saw blade placement.
•Sagittal Head Release Collar – Retracting the collar allows the rotation of the sagittal head to 12 different
positions (30° increments) to desired cutting angle.
•Trigger – Pressure sensitive switch for variable speed operation.
(RUN Mode) – Rotate the trigger to the vertical position. Depress trigger to operate handpiece.
(SAFE Mode) – Rotate the trigger to the horizontal position. Trigger cannot be depressed
to activate the handpiece.
Sagittal Head Release Collar
Battery
Receptacle
Blade Align ent Tabs
Sagittal Head
Blade Lock Button
Trigger*
*Shown in RU position
RUN Mode
SAFE Mode)(

Battery
Receptacle
9
Battery Pack Installation:
• Rotate trigger to the SAFE mode.
• Align the battery pack contacts on the top of the
battery pack with the battery receptacle on the
handpiece.
• Slide a battery pack into the battery receptacle until
the battery pack latch snaps indicating the battery
pack is secure.
• Rotate trigger to the RUN mode.
• Test the handpiece and battery pack by depressing
the trigger.
• Rotate trigger to the SAFE mode when not in
operation.
Battery Pack Removal:
• Rotate trigger to the SAFE mode.
• Press down on the battery pack latch and slide
battery pack out of the handpiece.
• Always remove battery pack when not in use.
Battery Pack - Installation & Removal
Battery Pack
Latch
Battery Pack
Contacts
Battery Pack
Latch

10
Saw Blade Installation:
• Rotate trigger to the SAFE mode.
• Align the saw blade hub notches with the blade
alignment tabs on the sagittal head.
• Press the hub of the saw blade down firmly on the
blade lock button.
• Slide the saw blade onto the sagittal head until fully
seated.
• Tug firmly on the saw blade to ensure it is installed
properly and will not pull out.
Saw Blade Removal:
• Rotate trigger to the SAFE mode.
• Press down firmly on the blade lock button.
• Slide blade out.
Saw Blade - Installation & Removal
Blade Lock
Button
Blade Align ent
Tabs

11
• Rotate trigger to the SAFE mode.
• Install battery pack and saw blade.
• Position the sagittal head at the desired cutting angle
by retracting the sagittal release collar and rotating the
head.
• If using cutting guide, place blade in guide prior to
activation and use irrigation.
• Rotate trigger to the RUN mode.
• Depress trigger to operate the handpiece.
• If power loss occurs during use, replace the battery
pack with a fully charged sterilized battery pack.
• Rotate trigger to the SAFE mode when not in
operation.
Handpiece Operation
Sagittal Release
Collar
Trigger*
*Shown in RU position
RUN Mode
SAFE Mode)(
Warning:
• Irrigation is required during resection in order to
prevent heat buildup which could cause bone
necrosis.

12
roubleshooting
Sagittal/Oscillator Saw – PM-X12-700
Sy pto Potential Cause Solution
Handpiece does not
start.
Trigger is in safe mode. Rotate trigger to run mode.
Battery pack is not installed. nstall battery pack.
Battery pack is not installed fully. Remove and reinstall battery pack.
Battery pack is discharged. Charge battery pack.
Trigger is activated too slowly. ncrease activation rate.
Handpiece has electrical/mechanical
malfunction.
Send handpiece to Brasseler U.S.A. Medical, LLC, for service.
Handpiece lacks
power.
Battery pack is discharged. Charge battery pack.
Battery pack is malfunctioning. Replace battery pack.
Variable speed throttle is out of adjustment. Send handpiece to Brasseler U.S.A. Medical, LLC, for service.
Handpiece stops
during use.
Battery pack is discharged. Charge or replace battery.
Circuit protection is activated due to
excessive loading.
Release trigger to reset circuit protection.
Handpiece runs after
trigger is released.
Trigger is malfunctioning. Send handpiece to Brasseler U.S.A. Medical, LLC, for service.
Handpiece will not
accept or retain saw
blade.
ncorrect blade used. Use only Brasseler USA® saw blades.

13
roubleshooting (continued)
Sy pto Potential Cause Solution
Saw blade cannot be removed. Blade is worn or damaged. Send handpiece to Brasseler U.S.A. Medical,
LLC, for service.
Blade lock button not depressed. See saw blade installation and removal.
f condition continues, send handpiece to
Brasseler U.S.A. Medical, LLC, for service.
Sagittal saw head won’t rotate. Release collar was not retracted. Retract release collar.
There is debris in collar. See cleaning recommendations.
Battery pack will not connect properly to
handpiece.
There is debris in the battery receptacle. See cleaning recommendations.
Battery pack contacts are damaged. Replace battery pack.
Battery pack latch is damaged. Replace battery pack.
Handpiece battery receptacle is damaged. Send handpiece to Brasseler U.S.A. Medical,
LLC, for service.
Battery pack cannot be removed from
handpiece.
Battery pack latch is damaged. Send handpiece and battery pack to Brasseler
U.S.A. Medical, LLC, for service.
Handpiece battery receptacle is damaged. Send handpiece and battery pack to Brasseler
U.S.A. Medical, LLC, for service.

14
Care & Maintenance
Brasseler USA® Surgical Power & Accessories
recommends that all BSPMAX™ II components
(handpieces, attachments and accessories
excluding battery packs) be returned to Brasseler
U.S.A. Medical, LLC, Service Department for routine
preventative maintenance every twelve (12) months.
Follow a regular care regimen that includes routine
cleaning and a thorough inspection for damage.
Routine preventive maintenance performed every
twelve (12) months by the Brasseler U.S.A. Medical,
LLC, Service Department can increase the reliability and
extend the life of your BSPMAX™ II Large Bone Power
System.
Checklist:
• Inspect all BSPMAX™ II components (handpieces
and accessories) to verify all components are
present.
• Ensure all handpieces and accessories have been
properly cleaned as outlined in the Cleaning
Recommendations section.
• Inspect all devices for proper set up and operation.
• Ensure the battery pack installs properly onto the
handpiece.
• Ensure the saw blade installs properly.
• Ensure there are no loose or missing components.
• Ensure there are no cracks in the battery pack case.
• Test* the handpiece and battery pack to ensure
that they are working properly.
• Check all moving parts for free movement.
• Check for unusual sounds or vibrations.
• Check for proper operating speed.
• If the recommended solutions provided in the
Troubleshooting section do not solve problem(s),
send the device(s) to Brasseler U.S.A. Medical, LLC,
Service Department as outlined in the Repair Service
section.
• Remove battery pack from handpiece when test is
completed.
* This maintenance test may be completed under
non-sterile conditions with a battery pack that has
not been sterilized.

15
Warnings:
• Clean and sterilize handpieces, battery packs and
accessories before every use.
• Prior to cleaning and sterilization, remove saw
blade and battery pack from the handpiece.
• DO NOT use solvents, lubricants, or other
chemicals, unless otherwise specified.
Cautions:
• Follow universal precautions and protective apparel
when handling and cleaning contaminated
instruments.
• Dispose of all saw blades properly after each use.
• DO NOT lubricate handpieces.
• DO NOT immerse handpieces and battery packs
in liquid. Contaminants will enter the equipment
and damage the device.
• DO NOT clean handpieces or battery packs in an
automated washer or ultrasonic cleaner.
• DO NOT clean handpieces with bleach, chlorine
based detergents, liquid or chemical disinfectants, or
any products containing sodium hydroxide (i.e.
INSTRU- LENZ®or Buell®Cleaner). They will
degrade the anodized aluminum coating.
Cleaning Procedures:
1. Remove battery pack and saw blade from the
handpiece.
2. Scrub debris from the handpiece using a brush
with stiff, non-metallic bristles and mild pH
balanced enzymatic cleaner. Manipulate all
moving parts of the handpiece to ensure all
debris is removed.
3. Rinse all external surfaces of the handpiece
under running tap water. Hold the handpiece
upright to prevent water from running into the
battery receptacle.
4. If water leaks into the handpiece, hold the
handpiece upright to allow drainage from the
battery receptacle area.
5. Visually inspect the handpiece for any remaining
debris. If any debris is present, repeat the
cleaning and rinsing procedure.
6. Gently shake the handpiece free of water.
7. Dry the handpiece with a clean lint-free soft cloth.
8. Inspect handpiece for damage and
malfunctioning. Return damaged components to
Brasseler U.S.A. Medical, LLC, Service Department.
9. Place handpieces into designated locations in the
tray and place tray into sterilization case. Fasten
sterilization case lid.
10. Sterilize as directed. See Sterilization
Recommendations section.
Cleaning Recommendations

16
Sterilization Recommendations
Steam sterilization has been found both safe and
effective for the sterilization of Brasseler USA®
BSPMAX™ II Large Bone Power System handpieces,
attachments and battery packs.
The instruments are capable of withstanding the
recommended exposure times and temperatures of
steam sterilization.
Warnings:
• The use of disinfecting solutions for an exterior
instrument wipe will not sterilize equipment and is
not recommended.
Cautions:
• DO NOT sterilize handpieces with Ethylene
Oxide (ETO).
• DO NOT sterilize handpieces in a STERIS®System,
STERRAD®System or comparable sterilization
methods.
• DO NOT sterilize handpieces in cold sterilization
like CIDEX®.
• DO NOT “peel pack” handpieces or attachments
for sterilization. Sterilization in a sealed pouch traps
moisture which can cause damage.
• DO NOT sterilize battery pack while connected to
the handpiece.
• Do not Flash Sterilize. It can decrease the life of
the device and may cause premature failure of the
device. Flash sterilization will void the warranty.
Notes:
• These processes have been validated as being
capable of cleaning and sterilizing the BSPMAX™ II
Sagittal/Oscillator Saw.
• The sterilizer manufacturer’s written instruction for
cycle parameters, load configuration and AAMI
guidelines for steam sterilization should be
followed.

17
Sterilization Type Mini u
Te perature
Mini u Exposure
Ti e
Dry Ti e
Pre Vacuum (Wrapped) 270° F (132° C) 4 Minutes 15-30 Minutes
Pre Vacuum (Wrapped) 273° F (134° C) 3 Minutes 15-30 Minutes
Gravity (Wrapped) 250° F (121° C) 100 Minutes 15-30 Minutes
Gravity (Wrapped) 270° F (132° C) 60 Minutes 15-30 Minutes
Parameters for Sterilizing BSPMAX™ II
Sagittal/Oscillator Saw
o Sterilize Battery Packs
See instructions for use provided with battery packs.
Sterilization Recommendations (continued)

18
Specifications
Operating:
• Ambient temperature : 50°F to 70°F (10°C to 21°C)
• Relative Humidity 30% - 75%
• Atmospheric Pressure: 700hPa to 1060hPa
ransport :
• Ambient temperature : -4°F to 158°F (-20°C to 70°C)
• Relative Humidity 10% - 100%
• Atmospheric Pressure: 500hPa to 1060hPa
With 9.6V Battery Pack
PM-X00-710
With 12V Battery Pack
PM-X00-715
Size (L x W x H) 6.9 x 1.25 x 6.3 in (175 x 32 x 160 mm)
Weight 2.3 lbs. (1.1 kg)
1. Perfor ance
2. Physical Characteristics
3. Environ ental Require ents
Speed Range 0-14,000 cpm 0-17,000 cpm
Oscillation Arc 5°
Duty Cycle 1 minute ON/ 5 minutes OFF, 5 times with a 3 hour rest.
Electrical Safety nternally powered equipment.

19
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
4. Electro agnetic Co patibility Require ents
Specifications (continued)
The BSPMAX™ II handpiece is intended for use in the electromagnetic environment specified below.
The user of the BSPMAX™ II handpiece should assure that it is used in such an environment.
E issions test Co pliance Electro agnetic environ ent - guidance
RF emissions
C SPR 11
Group 1 The BSPMAX™ handpiece uses RF energy only for its internal function.
Therefore its RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
C SPR 11
Class B The BSPMAX™ handpiece is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
EC 61000-3-2
N/A
Voltage fluctuations
Flicker emissions
EC 61000-3-3
N/A

20
NOTE 1: At 80MHz and 800MHz the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
I unity test IEC 60601
test level
Co pliance
level
Electro agnetic environ ent - guidance
Conducted RF
EC 61000-4-6
Radiated RF
EC 61000-4-3
3 Vrms
150 KHz to 80 MHz
3 V/m
80MHz to 2.5 GHz
N/A
N/A
3 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the BSPMAX™
handpiece, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d=1.67√P
d=1.67√P
80 MHz to 800 MHz
d=2.33√P
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
nterference may occur in the vicinity
of equipment marked with the
following symbol:
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Specifications (continued) 4. Electro agnetic Co patibility Require ents continued

21
The BSPMAX™ II handpiece is intended for use in the electromagnetic environment specified below.
The user of the BSPMAX™ II handpiece should assure that it is used in such an environment.
I unity test IEC 60601
test level
Co pliance
level
Electro agnetic environ ent - guidance
Electrostatic discharge
(ESD)
EC 61000-4-2
±6 KV contact
±8 KV air
±2, 4, 6 KV contact
±2, 4, 8 KV air
Floors should be wood, concrete or ceramic tile. f floors
are covered with synthetic material, the relative humidity
should be at least 30%
Electrical fast
transient/burst
EC 61000-4-4
±2 KV for power
supply lines
±1 KV for
input/output lines
n/a
n/a
Surge
EC 61000-4-5
±1 KV
differential mode
±2 KV
common mode
n/a
n/a
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Specifications (continued) 4. Electro agnetic Co patibility Require ents continued