0197

Medical Electric Saw Drill

Instructions for Use

Shanghai Bojin Medical Instrument Co., Ltd

Revision date: 2018-12-25

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 Table of Contents
1.0 INTRODUCTION.........................................................................................................4
1.1 Operating Principle..................................................................................................4
1.2 Indications.................................................................................................................4
1.3 Intended Use.............................................................................................................4
1.4 Contraindication.......................................................................................................4
1.5 Warnings and Precautions......................................................................................4
1.5.1 Warnings...................................................................................................................................5
1.5.2 Precautions................................................................................................................................6

1.6 Environmental Directives........................................................................................6

1.7 Warnings and Information Symbols......................................................................7
2.0 SYSTEM INSTALLATION AND OPERATION..................................................10
2.1 Product Description...............................................................................................10
2.1.1 Multi-functional Battery Handpiece.......................................................................................10
2.1.2 Composition............................................................................................................................14

2.2 Assembly/Installation Instructions.......................................................................15

2.2.1 Battery Installation..................................................................................................................15
2.2.2 Installation and removal of saw and drill attachments...........................................................17
2.2.3 Connecting and Removing Oscillating Saw Blades...............................................................18
2.2.4 Connecting and Removing Reciprocating Saw Blades..........................................................18
2.2.5 Installation and removal of drill bit........................................................................................18
2.2.6 Installation and removal of milling.........................................................................................18

2.3 Operating Instructions and Warnings.................................................................18

2.3.1 Trigger operation....................................................................................................................18
2.3.2 Change the direction of rotation.............................................................................................19
2.3.3 Warnings.................................................................................................................................19

3. RISK ANALYSIS........................................................................................................20
Remaining risks...............................................................................................................................20

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4.0 GENERAL INFORMATION..................................................................................21
Precautions....................................................................................................................21
4.1 Processing instructions...........................................................................................21
4.2 Limitations and restrictions on processing..........................................................27
4.3 Pre-treatment at the point of use before processing...........................................27
4.4 Preparation before cleaning..................................................................................28
4.5 Cleaning...................................................................................................................28
4.5.1 Manual cleaning......................................................................................................................28
4.5.2 Automated cleaning................................................................................................................29

4.6 Wipe.........................................................................................................................30
4.7 Drying......................................................................................................................31
4.8 Inspection, maintenance and functionality testing..............................................31
4.8.1 Maintenance and lubrication...................................................................................................31
4.8.2 Inspection and function test....................................................................................................31

4.9 Packaging................................................................................................................32
4.10 Sterilization...........................................................................................................32
4.11 Storage...................................................................................................................33
4.12 Transportation......................................................................................................34
4.13 Maintenance Schedule.........................................................................................34
5.0 TROUBLESHOOTING............................................................................................34
6.0 TECHNICAL SPECIFICATIONS..........................................................................34
6.1 Product Technical Specifications..........................................................................34
6.2 Product Environmental Requirements................................................................35
6.2.1 Environmental Technical Specifications................................................................................35
6.2.2 Electromagnetic Requirements...............................................................................................35

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 7.0 CUSTOMER SERVICE..............................................................................................40

1.0 INTRODUCTION

It is recommended that personnel study this manual before attempting to operate, clean, or sterilize
the devices or associated equipment. The safe and effective use of this equipment requires the
understanding of and compliance with all warnings, precautionary notices, and instructions marked on
the product, and included in this manual.

This equipment is designed for use by medical professionals completely familiar with the required
techniques and instructions for use of the equipment.

Service intervals, as listed in Section “4.13 Maintenance Schedule”, are required to keep the equipment
at its optimum operating performance.

1.1 Operating Principle

The medical electric saw and drill are powered by a detachable, rechargeable battery to provide rotary,
reciprocating, or oscillating force to the accessory (drill bits, saw blades, reamers or other attachments)
for bone cutting, drilling and milling. The handpieces are controlled by an activation trigger and switch
on the handpieces. The handpieces and accessories (including the batteries) may come into physical
contact with the patient (applied part).

1.2 Indications

The medical electric saw and drill perform cutting and drilling of soft tissue and bones. The fields of
application include: orthopedic, neurosurgical, cardiothoracic, hand and foot surgical procedures.

1.3 Intended Use

Same as Indications for Use above.

1.4 Contraindication

No.

1.5 Warnings and Precautions !

Do not bypass this section. It contains warnings and precautions that must be thoroughly understood
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before operating any of the equipment. Lack of understanding or adherence to these warnings and
precautions may result in injury or even death to the patient and/or surgical staff.

The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. !

WARNING: A warning contains critical information regarding serious adverse reactions and potential
safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the
information or procedures presented in a Warning may result in injury or other serious adverse
reactions to the patient and/or surgical staff.
PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner
for the safe and effective use of the equipment. Failure to observe the information or procedures
presented in a Precaution may result in damage to the equipment. !
NOTE: A note is added to provide additional focused information. This information has no critical effect
on the patient or equipment.

1.5.1 Warnings !
1. Eye protection is recommended when operating equipment. Eye injury may result.
2. It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use
of the equipment and its associated accessories.
3. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of
tampering.
4. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents,
cleaning solutions, or any material susceptible to ignition due to electrical sparking.
5. Do not use sterile equipment beyond the expiration date listed on the label. Sterility of the
product cannot be assured beyond the expiration date.
6. The device can only be used after sterilization according to the hospital standards, test and can
meet all requirements.
7. Do not contact the moving parts on the handpieces. Injury to the operator may occur.
8. Continually check handpiece for overheating. If overheating is sensed, immediately discontinue
use and return equipment for service. Overheating of the blade or bur may cause damage to the
blade or bur and may cause burns or thermal necrosis.
9. While handpiece is not in use do not place on patient/surgical drapes. Place handpiece on mayo
stand or sterile table.
10. Failure to follow the specified service interval could result in reduced instrument performance or
overheating of the handpiece. Overheating can lead to possible burn injury to the patient or
medical personnel. Rotation of handpiece usage per day will assist with proper performance.
(Refer to section “4.13 Maintenance Schedule”).
11. Do not attach, insert or remove accessories or attachments while the handpiece is operating.
Injury to the operator and/or damage to the equipment may occur. Place the handpiece safety
mechanism in the “safe” position prior to installation or removal of items.
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12. Avoid contact with cutting tip of blade, drill bit or bur when locking into handpiece. Tips are sharp
and may cause injury.
13. After use, blades, burs and drill bits may be a potential biohazard and should be handled and
disposed in accordance with acceptable medical practice and applicable local and national
requirements.
14. Do not use burs for plunge cutting. Injury or damage may occur.
15. Do not operate the Oscillating, Reciprocating Saws without a blade locked securely in place.
16. Do not use saw blades to pry, remove bone grafts, or as a leverage point. Patient or user injury
could occur.
17. Do not short circuit battery terminals, or allow them to contact metal objects. This could cause a
shock or burn injury and also damage the battery.
18. Do not expose batteries to fire or incineration. Exposure may cause injuries.
19. Inspect battery pack for damage (e.g., cracks in battery case) prior to use. Do not use damaged
battery packs. If battery pack is damaged and leakage or residue is noticed, do not allow it to come
in contact with skin, eyes or clothing. Burns may result. If contact occurs, flush area with copious
amounts of water and seek medical attention immediately. Dispose of or recycle properly.
20. Do not operate the Oscillating, Reciprocating Saw with the collet in the “open” position or without
a blade locked in the collet. Damage to the handpiece may occur.

1.5.2 Precautions
1. This device should only be used in compliance with its intended use.
2. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it
immediately for service.
3. Prior to each use, perform the following:
 Ensure all accessories are correctly and completely attached. (Refer to section “2.2
Assembly/Installation Instructions”).
 Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to
section “4.8 Functionality testing”).
4. Clean and sterilize all equipment according to instructions for use. (Refer to section “4.5 Cleaning”
and section “4.10 Sterilization”).
5. Always inspect for bent, dull or damaged blades, or drill bits before each use. Do not attempt to
straighten or sharpen. Do not use if damaged.
6. After each use, thoroughly clean and inspect the handpiece, attachments and accessories (Refer to
section “4.8 Maintenance”).
7. Do not stall handpieces, damage can occur.
8. Depletion of the battery charge will result if the battery pack is attached to a handpiece while the
handpiece is stored or is not being used.
9. Avoid contact of blades and drill bits with cutting blocks, retractors or other instrumentation.
Damage to blade, drill bit or instrumentation may occur.
10. Cutting tools are not installed in place: operate in strictly accordance with the steps described in
IFU.
11. In use of the device, if you find its noise is abnormal or it is overheated, you should immediately

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 stop using it, and contact the manufacturer or distributor, return the device back to the
manufacturer for repair.
12. It is not allowed to sterilize the battery in high temperature and pressure, nor can be put in the
hand piece for a long time. The battery should be removed right after the operation. If power off
happened during operation (the power tool does not work), the battery should be replaced
immediately.

1.6 Environmental Directives

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

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

1.7 Warnings and Information Symbols

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2.0 SYSTEM INSTALLATION AND OPERATION

2.1 Product Description

2.1.1 Multi-functional Battery Handpiece

The multi-functional Battery Handpiece is designed to be used as an all-purpose driver for reaming,
drilling, wire and pin driving, and with the proper attachments (reciprocator and sagittal only) will
perform sawing applications. This handpiece is designed to accept attachments.

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1. Attachment Quick Cup-Link — push backward to unlock and remove attachments from the
handpiece. It is not necessary to twist for insertion of attachment. Simply insert and push
attachment to lock in place.
2. Activation Trigger — Used to activate the handpiece. Depress when the switch is in the
“forward” or “reverse” position to operate.
3. Switch — To operate the handpiece, place in either the “forward” or “reverse” position. Place in the
“safe” position prior to connecting or removing any attachment or accessory and during non-use of
the handpiece.
4. Cover — Bottom cover.
5. Battery— Inside is battery.

2.1.2 Composition

The device is classified into three types of products: BYJZ-Ⅰ, BYJ-Ⅰ, BYZ-Ⅰaccording to different
purposes. BYJZ-Ⅰ is multi-functional drill and saw, BYJ-Ⅰ- electric saw, BYZ-Ⅰ- electric drill. Saw
attachments include oscillating (sagittal) saw attachment and reciprocating saw attachment, which are
used to hold sagittal saw blade and reciprocating saw blade respectively, and mainly perform sawing
function. Drill attachments are divided into high-speed drill attachment, medium-speed drill
attachment, low speed drill attachment, they are used to clamp drill bits and mainly perform drilling
function. Please see the composition of medical electric saw and drill in Table 1:
Table 1: Main components of each type
Type Main components
BJJZ-Ⅰ Hand piece, saw attachment (sagittal saw attachment and reciprocating saw
attachment), drill attachment (high-speed, medium-speed and low-speed),
milling attachment, charger, battery.
BJJ -Ⅰ Hand piece, saw attachment (sagittal saw attachment and reciprocating saw
attachment), charger, battery.
BJZ–Ⅰ Hand piece, drill attachment (high-speed, medium-speed and low-speed),
charger, battery.
The standards of BYJZ-Ⅰ, such as performance, safety, electromagnetic compatibility, cover those of
BJJ-I , BYZ-Ⅰ.
2.2 Assembly/Installation Instructions

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2.2.1 Battery Installation

1. Installation and removal of battery:

Open the bottom cover (rotate the knob clockwise in place), put the aseptic transfer kit(battery
protector) on the hand piece, hold the battery (with its head down) with a disinfected gauze, align the
concave groove of battery with convex groove of hand piece and insert the battery, remove the gauze
and close the battery cover (turn the knob counterclockwise). When the operation is completed, open
the bottom cover, hold the handpiece and shake until the battery automatically falls.
Caution: Do not drop the battery to the ground in case of breaking.
2. Instructions for charging and use of battery:

Warning! The battery must be charged before use to ensure adequate power. Battery laid
aside will loose power, and it will affect the power when doing operation.

Note: when charging, the battery is separated from the handpiece, so the hand piece cannot be used.
Note: The charger does not contain replaceable fuses.

Both power indicator and charging indicator lights are bright when the charger is connected to power
supply outside the operating room. Put the small head of battery down (as shown in Figure 4), align pin
sockets of the battery and charger, then insert the battery, the charging indicator turns from green to
yellow, which shows the charging begins. It takes about 3 hours to finish charging, when yellow light
turns to green, it shows that the charging is completed. The new fully charged battery cannot be used
immediately, it needs to wait until the battery becomes cool thoroughly, then put it into the aseptic
transfer kit (battery protector) and take them to the operating room before use. The fully charged
battery can be used at least 40 minutes at full load. This battery has no memory, so no need to
discharge before charging.
Caution: maintenance of the battery - it should be removed when will not be used for a long time, and
it should be charged regularly (once every 15 days) to ensure the battery life.
Caution: The detection of battery power - connect the charger to the power supply, align pin sockets of
the battery and charger and insert battery, if the indicator light turns to green, it means that the battery
is fully charged. Under normal circumstances, the battery can be charged and discharged for
approximately 500 times.
Caution: If the indicator does not turn green or the power of battery is low in use, it means that the
battery capacity is low, it needs to be recharged or replaced.
Caution: The battery cannot be placed in fire, otherwise it will cause an explosion. It should be put into
special box for batteries waste.
Caution: it should be inspected prior to use after long-term suspension.
Take out the battery from the device, and recharge;
Insert the battery into the device and check if it is working again according to the inspection procedures
prior to use.
WARNING: The battery is not automatically in a fully usable status. Please recharge it before use
especially when it has not been in use for a long time.

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How to use the charger

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2.2.2 Installation and removal of saw and drill attachments

The device must be sterilized prior to use (for detailed information see 3.2 Sterilization information).
After sterilization and before use, the device must be tested. The test method is to put a battery into
the hand piece (do not put the working components), push the trigger slightly, and the motor should
work, switch the forward/reverse switch, the motor changes its direction accordingly, otherwise, the
hand piece has a problem, in this case please stop using immediately, and contact the manufacturer or
dealer, and send it back to the manufacturer for maintenance.
Any blunt tools should be replaced timely, otherwise it will affect the sawing, drilling and other
functions.
This equipment needs customers to install and remove saw, drill attachments and tools according to
their requirements. Please read this instruction carefully before use.

To connect an attachment:
1. Place the switch in the “safe” position.
2. Pull the collet-lock in the front of the handpiece backward, then insert the drill attachment or saw attachment
into the handpiece, press to the bottom, release the collet-lock, then turn the attachments left to right gently to
completely reset. When the attachments are tightened, the installation is completed.
To disconnect an attachment:
1. Place the switch in the “safe” position.
2. Twist the attachment collet-lock. Remove the attachment (See image)

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2.2.3 Connecting and Removing Oscillating Saw Blades

To attach a blade:
1. Place the switch in the “safe” position.
2. Press down the locking button.
3. Insert the saw blade into the blade holder,
4. Release the locking button,
5. Carefully pull on the blade to ensure it is securely in place.

WARNING: The blade locking button must be completely closed to hold the blade firmly in place.
To remove the blade:
1. Ensure the switch is in the “safe” position.
2. Press the blade locking button to the “open” position.
3. Remove the blade.

2.2.4 Connecting and Removing Reciprocating Saw Blades

To attach a blade:
1. Place the switch in the “safe” position.
2. Rotate the blade locking knob counterclockwise to open the blade collet.
3. Completely insert the blade shank.
4. Carefully pull on the blade to ensure it is securely in place.

WARNING: The blade locking knob must be completely closed to hold the blade firmly in place.
To operate the handpiece, move the switch to the “run” position and depress the trigger.
To remove the blade:
1. Ensure the switch is in the “safe” position.
2. Rotate the blade locking knob counterclockwise. The blade locking collet will disengage.
3. Remove the saw blade.

2.2.5 Installation and removal of drill bit

1. Loosen the jacob chuck.

2. Insert the drill bit into the jacob chuck.
3. Tighten the jacob chuck, and use the jacob chuck key to clamp the drill bit.
4. Depress the trigger to work.
To remove the drill bit, loosen the jacob chuck with the key.

2.2.6 Installation and removal of milling

Insert the milling by pushing the lock of milling backward.

Push the lock of milling guard backward to load the guard.
Perform the steps backwards to remove it. When used, it should be washed with saline solution.
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 Caution: Continuous working time shoud be no more than 3 minutes.
WARNING: Do not run the handpiece without milling.

2.3 Operating Instructions and Warnings

2.3.1 Trigger operation

1. Push the trigger, the saw or drill start working, release the trigger, the saw or drill stop running.
2. The rotating speed of saw and drill can be controlled by changing the trigger amplitude. When
the amplitude is small, the speed is low, when the amplitude is big, the speed is high.

2.3.2 Change the direction of rotation

For drilling: The drill does not work when the arrow "" on the switch points to "OFF". Turn the

switch to the " " direction and the drill bit rotates counterclockwise. Turn the switch to the "
" direction and the bit rotates clockwise.
For sawing: To use the saw, turn the switch to the" "direction. The saw does not work
when the switch is right in the direction of "OFF" or is turned to " " direction.

Directions of the switch

Note: It is allowed to change the direction of rotation only when the drill is not working.

2.3.3 Warnings

Warning: It is not allowed to sterilize the battery in high temperature and pressure, nor can
be put in the hand piece for a long time. The battery should be removed right after the operation. If
power is cut during the operation (the power tool does not work), the battery should be replaced
immediately.
1. Check the radial run-out of a drill bit if it is good or not before use. A drill bit that shows a larger
than usual radial run-out can not be used. Check if the drill bit is sharp, otherwise change with a
new one. According to conventional surgical methods, the drilled object should be fixed without
being loose when drilled. The user should hold the drill steadily. If the drill bit breaks, it should be
replaced immediately.
2. The drill bit or the saw blade must be fixed firmly. It is necessary to lock the drill bit with a key.

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 After the saw blade is fixed, try to pull it hardly to ensure that the saw blade is firmly fixed to
prevent any accident.
3. The device and accessories should be placed in a dry place to prevent any corrosion, which will
affect operation performance.
4. In use of the device, if you find its noise is abnormal or it is overheated, you should immediately
stop using it, and contact the manufacturer or distributor, return the device back to the
manufacturer for repair.
5. The waste generated should be recycled or disposed of according to the provisions to avoid
affecting the environment.

3. RISK ANALYSIS
1. Cutting tools are not installed in place: operate in strictly accordance with the steps described in IFU.
2. Battery failure: regular inspection of battery.
3. Battery is not charged: charge the battery before an operation.
4. Battery is not fully charged: please check if the battery is fully charged before an operation.

Remaining risks

Rotation speed of the motor:

According to common bone drilling procedures, if the drilling speed is too high, it may cause burn the
bone. If drilling speed is too low, the operation time will be too long therefore, choose the appropriate
drilling speed. The speed at 500 rpm can achieve good performance after tests.

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 4.0 GENERAL INFORMATION
Precautions
1.Reprocessing must be performed immediately after each use. Clean within 30 minutes after use to minimize
the potential of blood and debris drying.
2.Cannulations, unlocking sleeves and other narrow sites require special attention during cleaning.
3.Cleaners with a pH of 7–9.5 are recommended. The use of cleaners with higher pH-values can –depending on
the cleaner – cause dissolution of the surface of aluminum, plastics or compound materials. The use of such
cleaners should be subject to the data regarding material compatibility in the corresponding data sheet.
4.At pH values higher than 11, the surface of stain-less steel can be affected.
5.For detailed information about material compatibility, refer to the technology document .
6.Follow the enzymatic cleaner instructions for use for correct dilution/concentration, temperature and water
quality. Devices should be cleaned in a fresh, newly-made solution.
7.Detergents used on the products will be in contact with the following materials: stainless steel, aluminum,
plastic, and rubber seals.
8.Never immerse the hand piece, batteries, battery case or attachments in aqueous solutions or in an ultrasonic
bath. Do not use pressurized water as this will cause damage to the system. Never wash (neither manual nor
automated cleaning are allowed) or sterilize the battery. This would destroy it with possible secondary damage.
9.Bojin recommends using new sterile cutting tools for each operation.
4.1 Processing instructions
Table A.1 — Processing steps performed in the sterile processing area of medical electric saw and drill
Process Process Stage Relevant Aspect Information to be provided by the Indicate if a
manufacturer, where applicable, including recommended
warnings and cautions step YES / NO /
N/A

All All • All • If specific protection of the processing NO

personnel is required, describe appropriate
personal protective equipment
Pre-treatment at Remove • Remove gross • Wipe clean YES
point of use contamination soiling • Rinse with water YES
before processing
• Flush channels N/A
• Other N/A
Prepare for • Prevent organics • Place in container with specified soaking N/A
transportation from drying solution
• Use appropriate pretreatments With cloth
• Containment for • Method(s) needed for protection of the Put in a Bojin
safe transportation medical device, environment and health sterilization case
care personnel (place in puncture proof
container, use of tip guards, holders and
brackets to secure items, specific
containment or labelling requirements etc.)
• Mode of transportation (any special By cart
carts, racks, or other delivery methods)

Preparation Preparation • Disassembly • If disassembly is required, provide device See 2.2.2 Installation
and removal of saw and
before cleaning specific disassembly instructions with
drill attachments
pictures

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 Process Process Stage Relevant Aspect Information to be provided by the Indicate if a
manufacturer, where applicable, including recommended
warnings and cautions step YES / NO /
N/A

• Gross debris • Use of shower or spray gun or other rinsing YES

removal mechanism
• Any special tools or equipment e.g. YES
brushes
• Testing • Leak testing of flexible endoscopes N/A
Procedures

Cleaning Manual cleaning • Accessories • Brushes (specify type, brush dimensions, YES
filament types etc. where relevant)

• Spray gun or other flushing accessories YES

(including any minimum and/or maximum
pressure)
• Any required dimensions for sinks, sink YES
configuration, etc.

• Other special accessories NO

• Water • Water quality Running cold tap

water
• Any maximum temperature the medical Yes
device can withstand

• Volume requirements No

• Process chemicals • Type of process chemicals to use (alkaline, Yes

acidic, neutral pH, enzymatic solution,
enzymatic foam, or water only etc.)

• Any special parameters that may be pH 7-9.5

different to those recommended or not
specified by the process chemical
• Rinsing manufacturer
• Any special parameters that may be different Yes
to those recommended or not specified by the
process chemical manufacturer such as methods
for determining adequate rinsing (minimum
volume of water, time, etc.)

Ultrasonic cleaning • Process chemicals • Whether detergent solution is to be used N/A

and if so, specify type

• Time • Duration of exposure of medical device to N/A

ultrasonic cleaning (if applicable)

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 Process Process Stage Relevant Aspect Information to be provided by the Indicate if a
manufacturer, where applicable, including recommended
warnings and cautions step YES / NO /
N/A

• Parameters • Required processing conditions for example N/A

time, temperature, ultrasonic power density and
frequency
• Connectors • Racks, connectors and load carriers N/A

Automated • Process chemicals • Type of process chemicals to (alkaline, Yes

cleaning acidic, neutral pH, enzymatic solution, rinse
aids)

• Water • Water quality Running cold tap

water
• Maximum temperature (if applicable) Yes
that medical device can withstand

• Cycle parameters • Cycle parameters (time, temperature or cycle type such as Yes
“instrument cycle” “basin cycle” etc.) for each stage, including
any minimum and/or maximum permissible values

• Connectors • Racks, connectors and load carriers Yes

• Lumen rack or dedicated washer Yes

• Basin rack Yes

• Other

Wipe Liquid • Automated or • Compatible liquid chemicals that can be Alcohol cotton
chemical manual used wipe
• Validated exposure time to liquid chemical N/A

• Water quality for rinse and minimum N/A

volume for rinsing
Thermal • Automated only • Maximum time and temperature that N/A
medical device can withstand

• Water quality for final rinse N/A

Drying • How the medical device should be dried Dry device using a
(pressurized air at recommended maximum air cleaning, soft lint-
pressure, manual wiping, heat, etc.) free cloth or
medical grade
compressed air

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 Process Process Stage Relevant Aspect Information to be provided by the Indicate if a
manufacturer, where applicable, including recommended
warnings and cautions step YES / NO /
N/A

• If wiping is advised, use low-linting wipes Use lint-free cloth

to wipe
• Maximum temperature the medical 134℃
device can withstand
Inspection, • Any requirements for ensuring functionality Yes
maintenance and such as sharpening, lubrication, testing device
functionality function, testing sheath integrity
testing

Packaging Reassembly • Whether device is not to be reassembled Partially

(or only partially reassembled) prior to reassembled
sterilization

• Device-specific reassembly instructions Take out battery

with pictures
Packaging • Type of sterile • Sterilization wrap N/A
barrier system (SBS)
if a particular
specification and/or
configuration of SBS
is required

• Preformed SBS N/A

• Rigid reusable container YES

• Other systems • Endoscope vacuum package systems N/A

• Endoscope transport containers with lids N/A

and/or disposable covers

Sterilization Moist heat • Air removal • Where it is necessary for attainment of YES
process sterilizing conditions, air removal require-
ments such as pulse high and low points, pulse
depth and number of pulses for which the
medical device has been validated
• Sterilization stage • Critical parameters such as time and YES
temperature for which sterilization of the
medical device has been validated
• Other parameters and/or accessories that YES
may be relevant to particular medical devices
such as pressure and density/mass (See
ISO/TS 17665-3)
• Required time and temperature for N/A
aeration (see ISO 10993-7)

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 Process Process Stage Relevant Aspect Information to be provided by the Indicate if a
manufacturer, where applicable, including recommended
warnings and cautions step YES / NO /
N/A

Vaporised • Cycle(s) and model/type of equipment N/A

Hydrogen for which the medical device has been
Peroxide (VHP) validated

• Accessories required N/A

Low temperature • Formaldehyde concentration, time, N/A

steam and temperature for which the medical device
Formaldehyde has been validated
• Required time and temperature for N/A
aeration
Other sterilization • Sterilization process including cycle and N/A
processes conditions for which the medical device has
been validated
Storage • Special storage conditions including Humidity: ≤85 ℃
duration, temperature and humidity.

Transportation • Transportation to • Special instructions for transportation of Yes

point of use the medical device for its intended use

• Shipping to out- • Special instructions for safe transportation Yes

side facility of a medical device to an outside repair
facility
• Special processing instructions for Yes
compromised medical device to render the
device safe for shipping and handling

• Method(s) needed for protection of the Yes

medical device, environment and personnel
(place in puncture proof container, use of tip
guards, holders and brackets to secure items,
specific containment or labelling requirements
etc.)

Table B.2
Manufacturer: Shanghai Bojin Electric Instrument&Device Co., Ltd. Method: Moist heat sterilization
Device(s): All reusable surgical instruments supplied by Shanghai Bojin Medical Instrument Co., Ltd. comprising
fixed assemblies (no moving parts) and single-use cutting and drilling tools.
NOTE：Aluminium alloy might be recognized by bright coloured (red, blue, green, yellow) coatings on metallic components.

Limitations on processing Repeated processing has minimal effect on these instruments. End of life is normally
determined by wear and damage due to use.

27
INSTRUCTIONS
Pre-treatment at the point Remove gross soil with disposable lint-free cloth /paper
of use:

Containment and No particular requirements.

transportation:
It is recommended that these instruments are processed as soon as is reasonably
practical following use.

Preparation before cleaning: No particular requirements. Disassembly not required.

Cleaning: Automated
Note: The washer should fulfill requirements specified in ISO 15883.
Step Duration(minimum) Cleaning Instructions
Rinse 2 minutes Cold tap water
Pre-wash 1 minute Warm water(≥ 40°C);
use detergent

Clean 2 minutes Warm water

(≥ 45°C);
use detergent

Rinse 5 minutes Rinse with de-ionized

(DI) or purified
water
(PURW)

Dry 40 minutes ≥ 90°C

If necessary, repeat cycle or use manual cleaning.

Cleaning: Manual Equipment: Neutral Detergent, brush, running water

1 Rinse gross soil from instrument.
2 Use soft brush, apply detergent solution to all surfaces ensuring that hinged
instruments are cleaned in both open and closed positions.
NOTE: Clean cannulations and blind ends using a soft bristled, 3.2 mm diameter
brush ensuring that full depth of the feature is reached.
3 Rinse using water for 5 minutes. Ensure that water passes through cannulations,
and that blind ends are repeatedly filled and emptied.
Wipe: Alcohol should be used in accordance with label instructions.

28
Drying: When drying is achieved as part of a washer cycle do not exceed 120°C.

Maintenance: Apply a small quantity of surgical grade lubrication oil to hinges. Discard blunt
or damaged instruments.
Inspection and Function Hinged instruments: Check for smooth movement of hinge without excessive “play”.
Testing: Locking (ratchet) mechanisms should be checked for action.
All instruments: Visually inspect for damage and wear. Cutting edges should be free
of nicks and present a continuous edge.
Check instruments with long slender features (particularly rotating instruments) for
distortion. Where instruments form part of a larger assembly, check assembly with
mating components.
Packaging: A standard sterile barrier system may be used. Ensure that the pack is large enough
to contain the instrument without stressing the seals.
In sets: Instruments may be loaded into dedicated instrument trays, or general-
purpose sterilization trays. Ensure that cutting edges are protected, and do not
exceed 10 Kg per tray. Wrap the trays using appropriate method.
Sterilization: Pre -vacuum steam sterilize, minimum of 3 minutes at 134 °C.
Do not exceed 136 °C.

Storage: No particular requirements.

Additional Information: When sterilising reusable instruments in one autoclave cycle ensure that the
sterilizer’s maximum load is not exceeded.
Manufacturer contact: See brochure for telephone and address of local representative or telephone +86-
021 39908516

The instructions provided above have been validated by the manufacturer of the medical device as being
capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the
processing, as actually performed using equipment, materials and personnel in the processing facility, achieves
the desired result. This requires verification and/or validation and routine monitoring of the process.
4.2 Limitations and restrictions on processing
Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and
damage due to use.
4.3 Pre-treatment at the point of use before processing
Remove gross soil with disposable lint-free cloth /paper, then wrap.

4.4 Preparation before cleaning

Disassembly
Before cleaning, remove all instruments and attachments from the power tool. Remove the battery case from
the handpiece and then remove the battery itself.
To clean the battery and the charger, wipe them off with a clean, soft and lint-free cloth dampened with
deionized water. Then wipe the battery and charger with a clean, soft and lint-free cloth dampened with an
alcohol based disinfectant that is either VAH listed, EPA registered or locally recognized. Follow the instructions
provided by the manufacturer.
Note: If the batteries are contaminated, spray disinfectant on an absorbent cloth and wipe clean. Take
care not to spray the contacts or touch both contacts at the same time with the damp cloth due to danger

29
of short circuiting.
Upon completion of charging the battery, wipe the battery with disinfectant prior to returning to use.

Handpieces and attachments may be processed using:

• Manual cleaning
• Automated cleaning with manual pre-cleaning

Note: Clean all movable parts in opened or unlocked position.

4.5 Cleaning
4.5.1 Manual cleaning
1. Remove debris
Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft lint-free cloth or
soft-bristled brush to assist in removing gross soil for cannulations of the hand piece and attachments.
Notes:
• Do not use pointed objects for cleaning.
• Brushes and other cleaning tools shall be either single-use items or, if reusable, be decontaminated at least
daily using a solution as detailed in section “3. Spray and wipe”.
• Brushes shall be inspected before daily use and discarded if they have degraded to the point where they may
scratch instrument surfaces or be ineffective due to worn or missing bristles.
Precaution: Never immerse the hand piece, batteries, battery case or attachments in aqueous solutions or in an
ultrasonic bath. Do not use pressurized water as this will cause damage to the system. The battery may never be
cleaned following the manual cleaning instructions.
2. Manipulate moving parts
Manipulate all moving parts such as triggers, sliding sleeves, attachment release rings, saw blade coupling and
switches under running tap water to loosen and remove gross debris.
3. Spray and wipe
Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes. Follow the
enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and
concentration/dilution.

4. Clean with detergent

Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum of
5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth
to remove all visible soil and debris Follow the enzymatic cleaner or detergent manufacturer’s instructions for
use for correct temperature, water quality and concentration/dilution.
5. Rinse with tap water
Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes. Use a syringe or
pipette to flush lumen and channels. Actuate joints, handles and other movable device features in order to rinse
thoroughly under running water.
6. Visually inspect device
Inspect the cannulations, sliding sleeves, attachment release rings, etc. for visible soil. Repeat steps 1–6 if visible
soil remains.
7. Final rinse with deionized/purified water
Final rinse with deionized or purified water for a minimum of 2 minutes.
8. Dry
Dry device using a clean, soft lint-free cloth or medical grade compressed air .

30
Cleaning brush

4.5.2 Automated cleaning

AUTOMATED CLEANING INSTRUCTIONS WITH MANUAL PRE-CLEANING
Notes:
• Manual pre-cleaning prior to automated cleaning is important to ensure cannulations and other difficult to
access areas are clean.
• Alternative cleaning procedures other than in the procedure described below (including manual pre-cleaning)
have not been validated by Bojin.
1. Remove debris
Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft lint-free cloth or
soft-bristled brush to assist in removing gross soil. For cannulations of the handpiece and attachments, the
cleaning brush shown should be used.
Notes:
• Do not use pointed objects for cleaning.
• Brushes and other cleaning tools shall be either single-use items or, if reusable, be decontaminated at least
daily using a neutral pH enzymatic solution for a minimum of 2 minutes.
Brushes shall be inspected before daily use and discarded if they have degraded to the point where they may
scratch instrument surfaces or be ineffective due to worn or missing bristles.
Precaution: Never immerse the handpiece, batteries, battery casing or attachments in aqueous solutions or in an
ultrasonic bath. Do not use pressurized water as this will cause damage to the system. The battery may never be
cleaned following the automated cleaning with manual pre-cleaning instructions.
2. Manipulate moving parts
Manipulate all moving parts such as triggers, sliding sleeves, attachment release rings, saw blade coupling
and switches under running tap water to loosen and remove gross debris.
3. Spray and wipe
Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes. Follow the
enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and
concentration/dilution.
4. Clean with detergent
Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum
of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free
cloth
to remove all visible soil and debris. Follow the enzymatic cleaner or detergent manufacturer’s instructions for
use for correct temperature, water quality and concentration/dilution.
5. Rinse with tap water
Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes. Use a syringe or
pipette to flush lumens and channels. Actuate joints, handles and other movable device features in order to
rinse thoroughly under running water.
6. Visually inspect device
Inspect the cannulations, sliding sleeves, attachment release rings, etc. for visible soil. Repeat steps 1–6 if visible
soil remains.

31
7. Load Washing Basket
Please use the specially designed tray for machine washing. Ensure that the attachments are positioned in an
upright position as shown and fully opened. This will ensure that the water can flow off any surfaces. Damage
due to improper reprocessing is not covered by the warranty.
8. Automated cleaning cycle parameters
Note: The washer should fulfill requirements specified in ISO 15883.

Step Duration(minimum) Cleaning Instructions

Rinse 2 minutes Cold tap water
Pre-wash 1 minute Warm water(≥ 40°C);
use detergent

Clean 2 minutes Warm water

(≥ 45°C);
use detergent
Rinse 5 minutes Rinse with de-ionized
(DI) or purified water
(PURW)
Dry 40 minutes ≥ 90°C

9. Inspect device
Inspect the cannulations, sliding sleeves, etc. for visible soil. If necessary, repeat the manual pre-
cleaning/automated cleaning cycle. Confirm that all parts are completely dry.
Precaution: Mechanical cleaning is an additional stress for power equipment, especially for seals and bearings.
Therefore, devices must be properly lubricated after automated cleaning. Furthermore, the device must be
serviced at least once per year.
4.6 Wipe
Use alcohol cotton to wipe the surface of handpiece, attachments.
4.7 Drying
See the instructions of recommended sterilization methods.
4.8 Inspection, maintenance and functionality testing
4.8.1 Maintenance and lubrication
To ensure a long service life and smooth operation, we recommend that the accessible moving parts of the
handpiece, battery casing and attachments are lubricated after each use with 1 drop of paraffine oil.
Spread the oil by moving the components. Wipe off excess oil with a cloth.
Failing to lubricate the parts will lead to damage and malfunction, increasing the risk of harm to the user and
patient.

Reamer/Drill
The following individual parts must be lubricated with 1 drop oil:
1 Attachment release ring
2 Trigger shaft
3 Rear end of the cannulation
Turn the attachment release ring clockwise and insert 1 drop of oil, then turn the release ring several times.
Insert 1 drop of oil in the gap between the seal ring and shaft. Insert the battery pack and run handpiece to

32
ensure oil is evenly distributed.
Lubricate battery casing release buttons from the inside, after which the buttons should be pressed several
times.
The following individual parts must be lubricated with 1 drop of oil:
Oscillating saw
1 Saw blade coupling
2 Locking knob for the saw blade quick coupling
3 Sliding sleeve for positioning the saw blade
4 Trigger shaft
Pull the sliding sleeve back and put 1 drop of paraffine oil on the exposed area. Then push the sleeve forward
and put 1 drop of oil on the other exposed area . To lubricate push the sleeve forward and backwards several
times. Then pull back the sliding sleeve and rotate the saw head several times.
Lubricate battery casing release buttons from the inside, after which the buttons should be pressed several
times.
Lubricating the battery casing
Place oil on the complete inside edge of the battery casing and distribute it evenly. Open and close the lid
several times to lubricate the sealing. Wipe off excess oil with a cloth.
Lubricating the attachments
After each use lubricate all moving parts of the attachment with 1 drop of oil (Use 1:100 RUHOF concentrate
lubricant to thoroughly lubricate). Spread the oil by moving the components. Wipe off excess oil with a cloth.
Insert 1 drop of oil in the gap between the seal ring and shaft of the attachment coupling. Connect the
attachment to the Reamer/Drill and let it run while the attachment tip is facing downward.

Precautions:
1. To ensure a long service life and reduce repairs, the handpieces, attachments and battery casings should be
lubricated after each use.
2. Only lubricate the handpieces, battery casings and attachments when clean.
3. The power tools and attachments may only be lubricated with 1 drop of oil. Lubricants with other
compositions may cause jamming, have a toxic effect or have a negative impact on the sterilization results.
4.8.2 Inspection and function test
Instructions
Visually inspect for damage and wear (e.g. unrecognizable markings, missing or removed part numbers,
corrosion, etc.). Check the handpiece controls for smooth operation and function.All movable parts should be
moving smoothly. Check that the triggers do not remain blocked in the handpiece when pressing on them.
Check that no residuals prevent the movable parts from moving smoothly. Check the release ring of the
handpiece and attachments for smooth operation, and check for function together with cutting tools. Check
instruments and cuttings tools for correct adjustment and functioning prior to every use. Do not use damaged,
worn or corroded components but send them instead to the Bojin Service Center. Failing to follow these
instructions will lead to damage and malfunction, increasing the risk of harm to the user and patient.
Preoperative Functional Test
Prior to each use, perform the following preoperative functional test:
1.Attach battery to handpiece.
2.Insert an attachment or blade into the handpiece. Gently pull on the attachment or cutting accessory to ensure
it is properly seated.
3.Run the handpiece for less than 5 seconds to observe any abnormal noises, vibrations or heat rise.
4.If any operating difficulties occur, return the handpiece for service.
4.9 Packaging

33
Put cleaned and dry products into their proper places in the Bojin sterilization case. Additionally, use an
appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier
System according to ISO11607. Care should be taken to prevent pointed and sharp instruments from contact
with other objects that may damage the surface or the Sterile Barrier System.

Dimensions (Length x Width x Height): According to the size of the product, different types of sterilization boxes
are customized.
4.10 Sterilization
Precaution:
Remove batteries from battery cases. Do not sterilize batteries as they will be damaged and no longer function.

Notes:
1. If the sterilization case is sterilized in a sterilization wrap, use the lid.
2. If the sterilization case is sterilized in a rigid container, the lid is not required.
Bojin Power Tool system may be re-sterilized using validated steam sterilization methods (ISO 13060 or national
standards). Bojin recommendations for packed devices and cases are as follows.
Cycle type Sterilization Sterilization Dry time (minutes)
exposure time exposure
(minutes) temperature
Saturated steam Minimum 4 Minimum 134°C 20–60
(pre-vacuum) Minimum 3 Minimum 134°C 20–60

Drying times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier
System, e.g., wraps or re-usable rigid container systems), steam quality, device materials, total mass, sterilizer
performance and varying cool-down time.

Precautions:
• The following maximum values may not be exceeded: 136°C over a maximum of 18 minutes.
Higher values can damage the sterilized products.
• Observe the packages prior to storage for visual moisture or dampness and if found on or within the pack, the
product should be repackaged and sterilized with an increased drying time.
• Do not accelerate the cooling process as it will damage the electronic components of the power tool and could
result in harm to the user and patient.
• Do not perform hot air, ethylene oxide, plasma and formaldehyde sterilization processes.

Note:
The device is composed of handpiece, saw and drill attachments, charger and battery.

34
The handpiece, saw and drill attachments can be cleaned, sterilized.
The charger, battery can only be wiped and clean, but can not be sterilized.

Handpiece saw and drill attachments

Battery Battery charger

4.11 Storage
Packaged and sterilized products should be stored in a dry, clean environment, protected from direct
sunlight,pests, and extremes of temperature and humidity. Use products in the order in which they are received
(“first-in, first-out principle“), taking note of any expiration date on the label.
4.12 Transportation
Avoid mechanical damage. It is recommended to reprocess instruments as soon as possible after use.
4.13 Maintenance Schedule
Regular and proper maintenance of your equipment is the best way to protect your investment. It is essential
that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability,

35
which will reward you with safer, less problematic product performance over time.
We advise you to conduct a dielectric strength and leakage current test every year to ensure that the equipment
is in compliance with safety requirements. The test should be performed according to GB9706.1 standards.
CAUTION: Electrical safety testing should be performed by Bio-medical engineer or qualified personnel.
To replace / return damaged or defect device or parts, please contact after-sales service department of Bojin.
The hand piece should be autoclaved in accordance with hospital standards, while the battery is not
autoclavable.

5.0 TROUBLESHOOTING
Table: Troubleshooting Guide
Symptoms Possible Cause Corrective Action
Handpiece does not • Handpiece mode switch • Move handpiece mode switch to an
operate. in “safe” position. operating position.
• Battery is not charged. • Replace with a charged battery.
• Battery faulty. • Connect another, fully charged battery to the
handpiece. If handpiece works, battery was either
not charged or faulty. Recharge battery and
reconnect to handpiece. If handpiece still does
not operate, the battery is faulty. Discard battery.

Excessive vibration, • Handpiece faulty. • Return handpiece for service.

noise or heat
Blade does not • Collet contains debris. • Thoroughly clean collet to remove all debris.
insert easily. • Blade is bent. • Do not use. Replace blade.
Collet stuck in the
open position or • Debris in collet. • Thoroughly clean collet to remove all debris.
difficult to turn.
Attachment does not • Debris in cannulation. • Thoroughly clean cannulation to remove all
fit into handpiece. debris.

6.0 TECHNICAL SPECIFICATIONS

6.1 Product Technical Specifications

Performance
The tolerance of speed or frequency of drills and saws of this equipment under non-load status is no more than
± 10%:
a) High-speed drill: 1100 r/min
b) Medium-speed drill: 600 r/min
c) Low-speed drill: 270 r/min
d) Milling drill: 17000 r/min
e) Sagittal saw: 15000 times/min
f) Reciprocating saw: 11000 times/min

The maximum output torque of electric drill:

High-speed drill : ≥2 N·m
Medium-speed drill: ≥3 N•m

36
Low-speed drill: ≥6 N•m
Milling drill: ≥0.1 N•m

Clamping force：
When medical electric saw and drill withstand axial tension of 30 N after clamping the blade and drill bit, they
must not be pulled out.
When medical electric saw and drill withstand 1.5 times of nominal torque after clamping the blade and drill bit,
they must not slip.
The main technical performance indicators
Hand piece Battery
Operating Working
Type Output power Voltage
Voltage current

BYJZ-Ⅰ ≥20W ≤20A

14.4v/12v
BYJ-Ⅰ ≥20W ≤20A 14.4v/12v/9.6V
/9.6V
BJZ–I ≥20W ≤20A
Charger
Output Recharging Recharging
Input voltage Input power
voltage current time
14.4v/12v/
AC 220V，50Hz 700mA About 3h 30VA
9.6V
Battery 1800mAh/1.2V×12
6.2 Product Environmental Requirements

6.2.1 Environmental Technical Specifications

Environmental Conditions Operating Storage and Transport
Temperature:
5℃～35℃ -10℃～+40℃
Relative Humidity:
30 %～75 % ≤90%
Atmospheric Pressure:
760 kPa～1060 kPa 500hPa～1060hPa

6.2.2 Electromagnetic Requirements

This chapter is about electromagnetic compatibility. The installation and use of medical electric saw and drill
must be performed in accordance with the information of electromagnetic compatibility shown below.

Electromagnetic compatibility of medical electric saw and drill comply with the requirements of YY 0505-2012.

All components of this device as a whole can meet the requirements of YY 0505-2012 after tests. The use of
unspecified chargers or cables other than chargers and cables provided by manufacturer may result in an
increase in the transmission of the equipment or a reduction in immunity, which may result in being unable to
meet the requirements of electromagnetic compatibility.

Portable and mobile RF communication equipment may have an impact on the use of medical electric saws and

37
drills.

WARNING: Medical electric saws and drills should not be used in close contact, or stacked with other
equipment. If it is necessary to be close or stacked, then it should be verified that they can function properly
under the used configurations.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Guidance and Manufacturer’s Declaration - Electromagnetic emissions

Handpieces are intended for use in the electromagnetic environment specified below. The
customer
or the user of the handpieces should assure that they are used in such an environment
Emissions test Compliance Electromagnetic environment - guidance
RF Emissions CISPR 11 Group 1 Handpieces use RF energy only for internal
functions; therefore, RF emissions are very
low and are not
likely to cause any interference in nearby
electronic
equipment.
RF Emissions CISPR 11 Class A Handpiece is suitable for use in all
establishments other than domestic and
those directly connected to the public low-
voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emissions IEC N/A Not applicable
61000-3-2
Voltage Fluctuations/Flicker N/A Not applicable
Emissions IEC 61000-3-3

38
 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Handpieces are intended for use in the electromagnetic environment specified below. The
customer or the user of the Hall 50 Handpieces should assure that it is used in such an
environment.
Immunity Test IEC60601Test level Compliance Level Electromagnetic
Environment Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
discharge ± 8 kV air ± 8 kV air concrete or ceramic
(ESD) IEC 61000-4-2 tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality
transients/bursts supply lines supply lines should be that of a
IEC 61000-4-4 ±1 kV for ±1 kV for typical commercial or
input/output lines input/output lines hospital environment.
Surge IEC 61000-4-5 ± 1 kV line to line ± 1 kV line to line Mains power quality
± 2 kV lines to earth ± 2 kV lines to earth should be that of a
typical commercial or
hospital environment.
Voltage dips, short <5% Ut (>95% dip in <5% Ut (>95% dip in Mains power quality
interruptions and Ut ) for 0.5 cycle Ut) for 0.5 cycle should be that of a
voltage variations on 40% Ut (60% dip in 40% Ut (60% dip in typical commercial or
power supply input Ut ) for 5 cycles Ut) for 5 cycles hospital environment.
lines IEC 61000-4-11 70% Ut (30% dip in 70% Ut (30% dip in If the user of
Ut ) for 25 cycles Ut) for 25 cycles handpieces
<5% Ut (>95% dip in <5% Ut (>95% dip in requires continued
Ut ) for 5 seconds Ut) for 5 seconds operation during
power mains
interruptions, it is
recommended that the
handpieces be
powered
from an
uninterruptable
power supply or
battery.
Power frequency 3A/m 0.8A/m Power frequency
(50/60 Hz) magnetic fields should
magnetic field be at levels
IEC 61000-4-8 characteristic of a
typical location in a
typical commercial or
hospital environment.

39
NOTE: Ut is the a.c. mains voltage prior to application of the test level.

Portable and mobile RF communications equipment should be no closer to any part of the
handpieces, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.

40
 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Handpieces are intended for use in the electromagnetic environment specified below. The
customer or the user of the Hall 50 Handpieces should assure that it is used in such an
environment.
Immunity Test IEC60601 Compliance Electromagnetic
Test Level Level Environment Guidance
Conducted RF 150KHz-80MHz 3 Vrms Recommended Separation Distance
IEC 61000-4-6 d=1.2√p

d=1.2√p 80MHz-800MHz
d=2.3√p 800MHz-2.5GHz

3V/m Where P is the maximum output where

Radiated RF 80 MHz to 2.5 3V/m P is the maximum output power rating
IEC 61000-4-3 GHz of the transmitter in watts (W) according
to the transmitter manufacturer and d is
the recommended separation distance
in meters (m). Field strengths from fixed
RF transmitters, as determined by an
electromagnetic site survey a , should
be less than the compliance level in
each frequency range b .
Interference may occur in the vicinity of
equipment marked with the following

symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by
absorption and reflection from structures, objects, and/or people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the handpiece is used exceeds the applicable RF
compliance level above, Hall 50 Handpieces should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the Hall 50 Handpieces.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

41
 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and
the Hall 50 Hand pieces @ 3Vrms
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the Hand pieces @ 3Vrms
Hand pieces are intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of handpieces can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the handpieces as recommended
below, according to the maximum output power of the communications equipment.
Rated Maximum Separation Distance According to Frequency of Transmitter (meters)
Output Power of 150kHz-80MHz 80MHz-800MHz 800MHz-2.5GHz
Transmitter (Watts) d=1.2 d=1.2 d=2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distances d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

42
7.0 CUSTOMER SERVICE

Assistance and Repair

If you need technical assistance regarding the use or application of this product, or you encounter a problem that
requires servicing or repair, contact your Bojin Sales Representative. Outside the P.R.C contact your local Bojin
Representative or your local Bojin Service Center (refer to www.bojin-medical.com for the proper contact
information).
Report any events involving injuries or malfunctions to the Bojin Regulatory Product Support.
Products returned for repair must have an authorized Service Request (SR) number prominently displayed on the
box and included on all paperwork. Refer to this number if making inquiries about the repair status. Please call
Bojin Customer Service and provide the following information to obtain an S.R. number prior to returning any
product for repair:

• Product Number
• Serial/Lot Number
• Reason for Return
• Original Invoice Number
• Date of Purchase
• Detailed description of the problem

Shanghai Bojin Medical Instrument Co., Ltd

Address: A Zone of F2, C Zone of F1, No.125, Longpan Road, Jiading District, Shanghai, China
Post code: 201800 Tel: 0086-21-39908516 Fax: 0086-21-39908016

BOJIN EUROPE SRLS

Via Ortana 20, 01030 Vitorchiano VT-Italy
Tel: 00 39 348 3307115 Fax: 00 39 348 3307115

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