MICROTYPE SURGICAL POWER TOOLS

System 3600

Operating manual

1
 Index

1 Product introduction Page 3

2 Product classification Page 3
3 Labels and symbols Page 4
4 Indications for use Page 4
5 Dangers and precautions Page 4
6 Technical specification Page 5
6.1 Control unit BJ36006-V Page 5
6.2 Foot pedal BJ36012 Page 7
6.3 Micro-handpiece BJ3600 Page 7
6.4 Bur attachments Page 8
6.5 Craniotomy attachment BJ3605 Page 8
6.6 Sagittal and reciprocating attachments BJ3601 – BJ3609 Page 9
6.7 Dedicated cranial perforator BJ3604 Page 9
7 Instructions for use Page 10
8 Cleaning and sterilization procedure Page 11
9 Fault handling Page 13
10 Electromagnetic Requirements Page 13
11 Transport and storage conditions Page 18
12 Operating conditions Page 18
13 Manufacturing date and period of use Page 19
14 Commitment Page 19

2
Surgical micromotor

1. Product introduction

Description
The device is an electrical surgical product for a wide range of operations for neuro, column and
orthopedics.

Main models and components

Model: BJWJZ-1

Main components: micro-handpiece, straight attachment, angled attachment, sagittal saw

attachment, reciprocating saw attachment, craniotomy attachment, control unit and pedals.
Furthermore, it is also possible to connect a handpiece with classical pistol grip handle (5000
series)

Note: to simplify, angled and straight attacks are collectively called bur attachments

2. Product classification

Based on the classification of the protection against electric shock, the device is considered a
general device belonging to the application part of the Ⅰ BF class.

It cannot be used when the flammable anesthetic gas is mixed with flammable air or narcotic or
mixed with oxygen or nitrous oxide.

Operating system: continuous operation with intermittent loading. Starting from cold, operate for
2 minutes in charging condition. Please stop the continuous use, allowing the device to cool down.
After the break, you can continue the operation.

3
 Spiegazione dei simboli generali usati

Attenzione Questo dispositivo contiene batterie Li-Ion

Leggere le Istruzioni per l’uso fornite prima che devono essere smaltite in modo ecolo-
3 Labels anddisymbols
usare il dispositivo. Li-Ion gico. A questo dispositivo si applica la diret-
Introduzione Introduzione tiva europea sulle batterie 2006/66/CE. Vedi
InformazioniConsultare
generali le Istruzioni per l’uso
Informazioni fornite
generali capitolo «Smaltimento» a pagina 47 .
prima di usare il dispositivo.

L’apparecchio è stato classificato come dispo-

2 Non riutilizzare
I prodotti monouso non devono essere riuti-
sitivo di classe BF in relazione a folgorazioni lizzati.
elettriche e correnti di dispersione. L’apparec-
chio è adatto per essere utilizzato sui pa- Il riutilizzo o la rigenerazione (p. es. pulizia e
zienti ai sensi delle direttive definite da CSA sterilizzazione) possono compromettere l’in-
601.1, IEC 60601-1 e UL 60601. IEC 60601- tegrità strutturale e/o causare il malfunziona-
1:2005, ANSI/AAMI ES60601-1 (2005), CAN/ mento del dispositivo, provocando lesioni,
CSA-C22.2 No. 60601-1 (2008) malattia o causando la morte del paziente.
Pressione atmosferica Pressione atmosferica
Spiegazione dei simboli generali usati
Inoltre, il riutilizzo o la rigenerazione di un
Non immergere il dispositivo in liquidi. Attenzione dispositivo monouso può generare il rischio
: typeTipo
B di ciclo di funzionamentoTipo conforme
di cicloalla
di funzionamentoLeggere le
di Istruzioni
conforme alla per l’uso
contaminazione, p. fornite
es. a causa primadi trasmis-
S9
Spiegazione dei simboli S9
generali usati di usare il dispositivo.
norma CEI 60034-1 norma CEI 60034-1 sione di materiale infettivo da un paziente Li-Ion
In relazione a folgorazioni elettriche, incen-
Attenzione all’altro.dispositivo
Questo Ciò può provocare
contiene lesionibatterieo Li-Ion
morte
dio, pericoli meccanici solo in conformità a Consultare le Istruzioni per l’uso fornite
10PB Grado
Leggere di protezione
le Istruzioni ingresso
per l’uso Grado
conforme di protezione
alla
fornite prima ingresso del
conforme paziente
alla o dell’utente.
che devono essere smaltite in modo ecolo-
IPX4 EN 60601-1
Warning. Read e ANSI/AAMI
the instructions
IPX4 ES60601-1
for use. (2005) Read the instructions
prima for use
di usare il dispositivo.
norma
di usareCEIil 60529
dispositivo.
e CAN/CSA C22.2 N. 60601.1 (2008). norma CEI 60529 Li-Ion gico. A questo dispositivo si applica la diret-
tiva europea sulle di
Synthes
contaminati.
L’apparecchio è
consiglia
stato Ogni
non rigenerare
batterie
prodotto
classificato
2006/66/CE.
come Synthes
dispo-
2
i prodotti
Vedi
contami-
Questo dispositivo
Consultare è conforme
le Istruzioni per l’usoaifornite
requisiti SM_109761 capitolo «Smaltimento» a pagina 47 .
CE Mark eManufacturer nato da BFsangue, tessuti e/o fluidi/materiali
Data
delladidirettiva
prima difabbricazione
usare 93/42/CEE perData
produttore
il dispositivo.
di fabbricazione
i dispositivi me- e sitivo
produttore
di classe in relazione a folgorazioni
elettriche corporei
e correnti nondi deve essere
dispersione. riutilizzato
L’apparec-e deve
dici. E’ stato autorizzato da un organo notifi-
cato esterno eèpertanto
L’apparecchio riporta ilcome
stato classificato simbolo CE.
dispo-
2chio è
Non riutilizzare
essere
adatto permaneggiato
essere in conformità
utilizzato
I prodotti monouso non devono sui alle diret-
pa-essere riuti-
zienti ai tive
sensi ospedaliere.
lizzati. delle direttive definite da CSA
Manufacturing
Data date.BF in relazioneData
sitivodidifabbricazione
classe di fabbricazione
a folgorazioni
601.1, IEC 60601-1 e UL 60601. IEC 60601-
elettriche e correnti di dispersione. L’apparec-
chio è adatto per essere utilizzato sui pa- IlAnche
1:2005, ANSI/AAMI se possono
riutilizzo o ES60601-1 sembrare
la rigenerazione (2005), integri,
(p.CAN/ i pro- e
es. pulizia
Fuse: T2AL250V CSA-C22.2 dotti possono
No. 60601-1
sterilizzazione)
presentare
(2008) compromettereol’in-
possono
piccoli difetti
non sterile Non ai sensi dellenon
zientisterile sterile definite
direttive da CSA
Non sterile avere subito sollecitazioni interne con conse-
601.1, IEC 60601-1 e UL 60601. IEC 60601- tegrità strutturale e/o causare il malfunziona-
guente indebolimento del materiale.
1:2005, ANSI/AAMI ES60601-1 (2005), CAN/ mento del dispositivo, provocando lesioni,
Non immergere il dispositivo in liquidi.
4 Indications for
CSA-C22.2
Non
use
sterile No. 60601-1 (2008) Non sterile
malattia o causando la morte del paziente.
Temperatura
Inoltre,
In relazione il riutilizzo o
a folgorazioni la rigenerazione
elettriche, incen- di un
Minimally
Precauzione: invasive operations,
Rischio di fuoco, extremity,
esplosione
SM_109761 Non immergere il dispositivo in liquidi.
column, neuro, orthopedic.
e ustioni. dio, dispositivo
pericoli meccanici monouso
solo in può generare
conformità a il rischio
Non utilizzare se la scaldare
confezione Nonè utilizzare10PBse la confezione è
Non smontare, frantumare, a temperatura EN 60601-1 e ANSI/AAMI ES60601-1 (2005)trasmis-
di contaminazione, p. es. a causa di
danneggiata. danneggiata.
superiore a 60 °C/140 °F o incenerire le celle della
5batteria.
Dangers and precautions
In relazione a folgorazioni elettriche, incen-
e CAN/CSA sione di materiale
C22.2
Umidità N. 60601.1
relativa infettivo
(2008). da un paziente
all’altro. Ciò può provocare lesioni o morte
1.Connect the dio,attachment to the micro
pericoli meccanici solo inhandpiece
conformità before
a operating the instrument.
10PB Questo dispositivo
del paziente è conforme
o dell’utente. ai requisiti SM_10976
2. The instrument must be
EN 60601-1 sterilized before
e ANSI/AAMI use. (2005)
ES60601-1
della direttiva 93/42/CEE per i dispositivi me-
3. The user muste CAN/CSA C22.2 N.the
have acquired 60601.1
technical(2008).
experience necessary tostato
operate this device.
dici. E’ Synthesautorizzato
consiglia da
di un
nonorgano
rigenerarenotifi-
i prodotti
4. Try the instrument before using it. cato esterno e pertanto
contaminati. Ogniriporta
prodottoil simbolo
Synthes CE. contami-
Questo dispositivo è conforme ai requisiti SM_109761
nato da sangue, tessuti e/o fluidi/materiali
della direttiva 93/42/CEE per i dispositivi me-
a) Burs and dici.saw E’blades
stato must be securely
autorizzato fastened
da un organo to the device in acorporei
notifi- safe manner.non deve No essere
vibrations riutilizzato e deve
4 CE.
essere maneggiato in conformità alle diret-
cato esterno e pertanto riporta il simbolo Colibri II Istruzioni per l’uso DePuy Synthes 5
tive ospedaliere.

Anche se possono sembrare integri, i pro-

dotti possono presentare piccoli difetti o
avere subito sollecitazioni interne con conse-
guente indebolimento del materiale.
Precauzione:
SM_109761
Rischio di fuoco, esplosione e ustioni.
Non smontare, frantumare, scaldare a temperatura
should be visible from attachments or cutting tools. Check the radial movement of the tips. Do not
use if the radial movement is too wide. Check if the cutter is sharp, if it is not sharp enough, it must
be replaced in time.
b) If the bur breaks, replace it immediately.
c) The bur is a consumable product and its duration is generally 10 uses.
d) The control unit has a short-circuit protection device. When a short circuit fault occurs, the
device automatically interrupts the output power.
e) After the product has completed its life cycle, please dispose of it according to the relevant
regulations.

6 Technical specification

6.1 Control unit BJ36006-V

1. Power supply: AC 110V/220V 50HZ

2. Input power: 450VA

Image: Control unit BJ36006-V

5
1. Button for switching on / off
2. Connection port for micro-handpiece BJ3600
3. Connection port for BJ5000 series handgun modular gun, or dedicated handpiece for cranial
drilling BJ3604
4. Connection port for BJ36012 pedal board
5. On-screen button to choose between activation by footswitch or by screen
6. Direction of rotation
7. Increase and decrease speed (indication of same on screen in rpm)
8. Blade mode (for micro-handpiece BJ3600)
9. Milling (bur) mode (for micro-handpiece BJ3600)
10. Cranial perforator mode (for dedicated BJ3604 handpiece)
6
6.2 Foot pedal BJ36012

Image: Foot pedal BJ36012

Cable: 3 meters
Water resistant IPX6

6.3 Micro-handpiece BJ3600

Input voltage: DC 12V
Output power: ≥100W
Noise: ＜65dB

Image: Micro-handpiece BJ3600

1. Handpiece connector
2. Motor control connector
3. Handpiece
3. Cable

7
6.4 Bur attachments

Speed: 1000rpm-100000rpm
Error：±8%
Torque: 0.10 Nm
Connection type: standard round shank 2,35mm

6.5 Craniotomy attachment BJ3605

Speed: 1000rpm-100000rpm
Error：±8%
Torque: 0.10 Nm

8
6.6 Sagittal and reciprocating attachments BJ3601 – BJ3609

Speed: 1000rpm-15000rpm
Error：±8%
Connection type for sagittal saw blades: code BJ3501
Connection type for reciprocating saw blades: code WF

6.7 Dedicated cranial perforator BJ3604

Speed: 100rpm - 1100rpm

Torque: 2.24Nm
Connection type for cranial drill bit: code BJP007

9
NOTE: THIS USER MANUAL WILL FOCUS ON THE USE OF THE CONTROL UNIT WITH THE BJ3600 HIGH-SPEED
MICRO-HANDPIECE. FOR THE INSTRUCTIONS FOR USING THE BJ5000 SERIES, REFER TO THE MANUAL FOR USE OF THE
SAME SERIES.

7 Instructions for use

1. Connect the electric cable to the instrument console, the light indicator indicates the power on and by pressing the
start key, the monitor indicates the icons of the different and optional operations.
2. Once activated, the instrument shows the PEDAL mode and shows the minimum operating speed; the MANUAL mode
is not shown with the icon.
3. In the pedal control mode, the screen rotation change buttons are not accessible. Press the speed button to change it,
setting the maximum reachable. By pressing the pedal, the rotary speed of the motor increases linearly from the lowest
point to the highest point that was previously set.
4. In manual control mode, press the activation button. Manual control mode is shown with the button icon. The pedal
switch is not accessible. Then, adjust the parameters on the control panel to set the speed and direction of the motor,
press the manual control mode activation button again, the motor will run in the current speed and direction.
5. When the instrument is not in use, please disconnect the power cord.

Note:
• After following the instructions, now described, please pay attention that there are no noises or imperfections of the
instrument.
• In manual control mode, do not touch the pedal control mode activation button, otherwise it will turn into the pedal
control mode.
• Depending on the different surgical needs, it is possible to select different drill attachments (straight or angled) and
insert boring bits. To lock the cutter, insert it up to the bottom with the locking system in the open position. Once the
cutter is inserted, rotate the locking system in the opposite direction. To make sure that the cutter is firm, pull it slightly.
• To connect the sagittal blade, press the button on the attachment. Keeping the same pressed, insert the blade and
make the holes of the blade correspond with the teeth of the locking system. Once the connection has been made,
release the button and check that the blade is firmly in place by pulling it slightly.
• To connect the blade to each other, rotate the locking system and align the blade inlet line. Insert the blade, as the
locking system rotates. Once the blade is inserted, release the rotating part. Check that the blade is firm, pulling it
slightly.

10
8 Cleaning and sterilization procedure

The devices must be cleaned and sterilized before each use. Use protective equipment every time even such operations
are performed.

Use a neutral pH detergent, not exceeding 10.5. Fill the sink with water and detergent, mix gently by hand. Before
cleaning the device, remove all accessories, battery connections and shells. Rinse the device under warm running water
(between 27 ° C and 44 ° C) using a soft, lint-free cloth and a soft bristle brush. Remove coarse dirt. Be careful to move
all moving parts, such as triggers, bushings and selectors under running water to remove debris. Do not use sharp
objects.

Never immerse the devices in an aqueous solution or in an ultrasonic bath. Also, do not allow moisture to remain inside
the cannulated parts, in the selectors or in the electrical connection areas. Do not rinse the handpiece from the front or
use pressurized water to avoid damaging the system.

Use a soft brush with a diameter suitable for the cannulated part to clean it. Pay attention that the brush passes through
the total length of the affected area. Move all the moving parts to clean the residual debris. Keep the device tilted, with
the head pointing downwards, under running water. Be careful to completely remove the detergent under running
water.

Visually inspect the device, including cannulations to check for traces of dirt. If present, repeat the previous steps. I
would place inclined devices on absorbent cloths to dry them. Or use compressed air (medical use).

To clean a connection cable, hold it by both ends and clean the cable using a soft cloth dampened with detergent. Finally
dry with compressed air.

11
 .

When sterilizing, perform the following sterilization cycle validated by Bojin to obtain optimum performance. Steam
sterilization

Wrapping method Cycle Minimum temperature Maximum Temperature Minimum Exposure Minimum dry time

Wrapped Pre-vacuum 129°C 134°C 4 minutes 8 minutes

Note: The Operator must ensure that the affected parts have been sterilized, before use.

12
9 Fault handling

Maintenance
For safety reasons, electrical microsurgery devices must be inspected once a year. For
maintenance operations, please contact your dealer or contact the Bojin after-sales service directly
for maintenance, performed by the instrument's experts.

Removing the problem

The device is equipped with short-circuit protection. In case of connection or other abnormal use
of the pause button, please restart the power supply and check if this returns the instruments to
normal functionality. If the problem is not resolved, contact the after-sales service for the
maintenance of the instruments.

Repair of the problem

In addition to the fuse, the equipment contains no repairable parts inside, so do not attempt to
open the enclosure, the foot switch, the control box and other components. If other problems
persist, contact the after-sales service for instrument maintenance.

For maintenance performed by skilled and qualified figures, please turn off the power switch,
check if the fuse is blown. If it is, replace it with the one from the T2AL250V specifications.

10 Electromagnetic Requirements

Operation is subject to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that
may cause undesired operation.
Use of accessories other than those recommended may result in non-compliance with
electromagnetic compatibility and immunity standards.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

13
3600 Handpieces are intended for use in the electromagnetic environment specified below.
The customer or the user of the 3600 Handpieces should assure that they are used in such
an environment
Emissions test Complian Electromagnetic environment - guidance
RF Emissions CISPR 11 ce
Group 1 The 3600 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 The 3600 Handpieces are intended for use by
healthcare professionals only and 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

14
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The 3600 Handpieces are intended for use in the electromagnetic environment specified
below. The customer or the user of the 3600 Handpieces should assure that it is used in
Immunity Test
such an environment. IEC 60601 Compliance Level Electromagnetic
Test Level Environment
Electrostatic ± 6 kV contact ± 6 kV contact Floors
Guidanceshould be
discharge (ESD) IEC ± 8 kV air ± 8 kV air wood, concrete or
61000-4-2 ceramic tile. If floors
are covered with
Electrical fast ± 2 kV for power ± 2 kV for power Mains powermaterial,
synthetic quality
supply lines supply lines should
the relative humidity
should be at least
transients/bursts be that of a typical
30%.

IEC 61000-4-4 ± 1 kV for ± 1 kV for commercial or

input/output lines input/output lines hospital
environment.

Surge ± 1 kV line to line ± 1 kV line to line Mains power quality

should

IEC 61000-4-5 be that of a typical

± 2 kV lines to earth ± 2 kV lines to earth commercial or
hospital

environment.
Power frequency 3 A/m 3 A/m Power frequency
(50/60 Hz) magnetic fields
magnetic field should be at levels
IEC 61000-4-8 characteristic of a
typical location in a
typical commercial or
15 hospital
environment.
Voltage dips, short <5% Ut (>95% dip in <5% Ut (>95% dip in Mains power quality
interruptions and Ut) Ut) should be that of a
input linesvariations
voltage 40%
for 0.5Utcycle
(60% dip in 40%
for 0.5Utcycle
(60% dip in environment. If the
typical commercial or
IEC 61000-4-11
on power supply Ut) Ut) user of
hospital the 3600
70% Ut (30% dip in
for 5 cycles 70% Ut (30% dip in
for 5 cycles during powerrequires
Handpieces mains
Ut) Ut) interruptions, it is
continued operation
for 25 cycles for 25 cycles recommended that
the 3600

<5% Ut (>95% dip in <5% Ut (>95% dip in Handpieces be

Ut) Ut) powered from an
for 5 seconds for 5 seconds uninterruptable
power supply or
battery.
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
3600 Handpieces, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.

16
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

The 3600 Handpieces are intended for use in the electromagnetic environment specified
below. The customer or the user of the 3600 Handpieces should assure that it is used in
Immunity Test
such an environment. IEC 60601 Compliance Level Electromagnetic
Test Level Environment
Recommended
Guidance
Separation Distance
Conducted RF IEC 150 kHz to 80 MHz 3 Vrms
61000-4-6RF
Radiated 80 MHz to 2.5 GHz 3 V/m d = 1.2 √√ PP 80 MHz to
IEC 61000-4-3 800 MHz
Where P is the maximum output where P is the maximum output dpower = 2.3 √rating
P 800ofMHz
the
transmitter in watts (W) according to the transmitter manufacturer and d is the
to 2.5 GHz
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 each1:frequency
NOTE At 80 MHzrange b. MHz, the higher frequency range applies.
and 800
Interference
NOTE 2: These mayguidelines
occur nearmay
the not
equipment
apply inmarked with the Electromagnetic
all situations. following symbol: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 3600 Handpieces is
used exceeds the applicable RF compliance level above, 3600 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 3600 Handpieces.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

17
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the 3600 Handpieces @ 3Vrms

3600 Handpieces are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of 3600 Handpieces can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the 3600
Separation Distance
Handpieces as recommended Accordingto
below, according to the
Frequency
maximumof Transmitter (meters)
output power of the
Rated Maximumequipment.
communications m
Output Power of 150 kHz to 80 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter MHz d 3.5 P d 7 P
(Watts) d 3.5 P E E
0.01 0.12 0.12 1 0.23 1
0.1 0.34
v1 0.34 0.74
1 1.7 1.7 2.3
10 3.7 3.7 7.4
100 11.7 11.7 23.3
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
Note 1: (W) according
At 80 MHz and to 800
the transmitter manufacturer.
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.

11 Transport and storage conditions

1.ambient temperature range: -10℃～40℃

2.relative humidity range: ≤90%
3.Kpa: 500hPa～1060hPa

12 Operating conditions
normal working conditions:
ambient temperature：5 ℃～35℃
relative humidity：35%～75%
Kpa: 860hPa～1060hPa
Supply voltage：AC 110V/220V，tolerance±10%；frequency：50Hz，tolerance±1Hz
motor power：（DC）12 V
There is no conductive dust, explosive gas, and corrosive gases
13 Manufacturing date and period of use

Production date: see label

Duration: 5 years

14 Commitment

A) This device has no removable parts for non-professional personnel, in case of failure,
please contact the after-sales service.

B) If you need technical information (such as circuit diagram, list of components, illustrations,
correction details, etc.) you can request it at the Technical Assistance Center.

Shanghai Bojin Electric Instrument & Device Co., Ltd. Bojin Europe srls
Add: Room 606, No. 3388, Gonghexin Road, Shanghai City. China,200436 Via Ortana 20, Vitorchiano 01030
Web: http://www.bojin-medical.com Italy
Tel: 0086 21 66308078 eurosales@bojin-medical.com
Fax: 0086 21 66527013

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