RuiJin S Series User manual
RJ--Rev:
Please read this manual carefully before
use and keep it properly
Revised date: Apr,
Version/Times: B/
MEDICAL ELECTRIC SAW DRILL
Operating Manual S Series
SS- Oscillating Saw SS- Sternum Saw SS-Reciprocating Saw
SM
0553-2673688
RJ-MP
RJ-PS
Model
Registrant/manufacturer name：Wuhu Ruijin Medical Instrument & Device Co., Ltd.
Registrants Residence/ Production Address: 33rd , East Wanchun Road, Wuhu
Economic and Technological Development Zone, Wuhu , Anhui Province, P.R.C.
After-sales service unit: Wuhu Ruijin Medical Instrument & Device Co., Ltd
TEL: 0553-2673688 FAX: 0553-2672513 Zip Code: 241000
Production License: W.X.Z.Z.XU NO.: 20160013
Medical Device Registration Certificate: W.X.Z.Z. No.: 20162284
®
01
01
01
02
03
04
Product information
Corporate information
Main performance parameters
The structural composition
The scope of application
Contraindications, precautions,
warnings and explanatory notes
Product introduction
Product introduction
01
Sequence
RJ-PS
RJ-MP
Performance parameters
Model No.:
FOREWORD
Thank you for using this product！This manual contains important contents that must be
understood for safe and proper use of the product.
The instruction manual is a part of the product. Therefore, this manual should be placed
in a proper position for easy reference at any time for the whole lifetime.The product must
be operated by trained personnel with relevant knowledge and experience. All personnel
must read this instruction carefully before using this product.
This manual shall be transmitted to subsequent owners or users of the product.Any
duplication, photogrammetry, digital post-processing or duplication is prohibited without
consent of Wuhu Ruijin Medical Instrument & Device Co.,ltd.
This product is safe and reliable to use, except for the risk s arising from special factors like
operated by non-professionals or used for other purposes,etc.Therefore, please follow strictly
the following rules to avoid accidental use. The product must be operated by professionals.
Product maintenance must be carried out by professional technicians or skilled users of
Wuhu Ruijin Medical Instrument & Device Co.,ltd and the authorized
person.
If there are any operation problems not mentioned, please contact WuhuRuijin Medical
Instrument & Device Co.,ltd.
Instructions are subject to change without prior notice.Please put the manual in a proper
position for reference.
I.Product information
II.Corporate information
Registrant/manufacturer name：Wuhu Ruijin Medical Instrument & Device Co., Ltd.
Registrants Residence/ Production Address: 33rd , East Wanchun Road, Wuhu
Economic and Technological Development Zone, Wuhu , Anhui Province, P.R.C.
After-sales service unit: Wuhu Ruijin Medical Instrument & Device Co., Ltd
TEL: 0553-2673688 FAX: 0553-2672513 Zip Code: 241000
Production License: W.X.Z.Z.XU NO.: 20160013
Medical Device Registration Certificate: W.X.Z.Z. No.: 20162284
III.Main performance parameters
Product Name: Medical Electric Saw Drill
Product Model No.: RJ-MP RJ-PS
Product technical requirement No.: W.X.Z.Z No.:20162284
Main performance parameters:
Non-loading rotation speed or frequency of electricsaw and drill:
i. Drill rotating speed 120rpm
ii. Saw frequency: ≥ times/min
iii.Output power: ≥50W
iv. Temperature rise: the temperature rise of the shell is no
more than 0°C after 5min of non-loading operation;
v. Non-loading noise: drill saw non-loading noise ≤75dB(A);
vi. Electric saw & drill saw blades shall be heat treated and its hardness
shall be no less than 30 HRC.
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
i.RJ—MP
(i).SM
IV.The structural composition
0302
This product is mainly composed of handpiece, drill components, saw components,
accessories, battery and charger.
All instructions in this manual are for the purpose of explanation only. If the appearance and function
are inconsistent with the real object, the real object shall prevail.
Note
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
Applied in bone drilling and cutting in orthopedic surgeries for medical
organization.
V.The scope of application
ii.RJ—PS
0504
VI.Contraindications, precautions, warnings and explanatory
notes
i.Contraindications
NO
ii.Precautions
(i)Check whether the radial run-out of the bit is intact before use. The bit with large
radial run-out cannot be used. Check the sharpness of the drill bit. The drill body
should be fixed during drilling without loosening according to conventional
surgical methods.
(ii).The drill bit must be firmly fixed well with drill chuck key to avoid accidents.
Products and accessories should be placed in a dry place to prevent corrosion
after use.
(iii).The battery shall not be disinfected by high temperature, high pressure or stay
in the machine for a long time, take out battery after the operation.If power is cut
off during the operation (the handpiece does not work), the backup battery should
be replaced immediately.
(iv).If there is abnormal sound when using,stop using it immediately. Please contact
with the manufacturer or distributor immediately and return the machine to the
manufacturer for repairing.
(v).Charge the battery immediately after use. If the battery is not used, charge it every
three months to prevent battery loss.
iii.Warning and suggestive notes
Supplementary external mark： Working schedule：Short time operation
Each starup time shall not exceed 5min.
Marking pattern description:
B-type equipment
Battery cover marking:
Unlock Lock
Recycling marks for electronic products at the end of their life:
The medical electric drill saw is classified according to the protection of electronic
equipment from shock and vibration. The motor belongs to B-type equipment of
internal power supply, and the charger belongs to class Ⅱ B-type ordinary equipment;
The equipment shall not be used with a mixture of flammable anesthetic gas or carbon
oxide; Sterilization must be carried out before use.
Rotation mark: F: Forward R: Reverse S: Stop
Operation
VII.Installation and dis-assembly
This product is professional medical device, the installation and dis-assembly
must be performed by medical personnel with appropriate technology or with
appropriate professional training.
Instructions
i.Installation and dis-assembly of drill bits
( i).Loosen the chuck by turning counterclockwise
with the drill chuck key;
(ii). Insert the prepared bit into the three-jaw hole
(iii).Turn the drill chuck key clockwise and tighten
it vigorously.
(vi).Conversely, the drill bit can be removed
ii.Installation and removal of oscillating saw blade
( i). Turn the knob counterclockwise to lift the
pressure bar;
(ii). Insert the blade into the interface along
the guide direction. Align the seven holes
of the blade with the seven lugs of the product.
Press down gently to make the lugs pass
through the saw blades holes.
(iii).Turn the knob clockwise and pull down the
pressure bar Locking saw blade;
(vi).Conversely, the saw blade can be removed.
Drill chuck
Drill bit
Key
Compressive bar
Saw blade
Knob
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
0706
iv.Installation and removal of cranial milling cutter
iii.Installation and removal of sternal saw/reciprocating saw blade
Saw blade knob
Protective rack
Limit screw
( i).Hold the knob with one hand, apply force to the limit
screw, and rotate the knob;
(ii). Pull the protective rack with the other hand, and the
protective rack can be removed;
(iii).Rotate the saw blade knob;
(iv).Aim the saw blade at the installation slot, loosen the
saw blade knob, and then saw blades is installed well.
(v). Repeat the operation with serial number 1, insert the
protection frame into the slot;
(vi).Release the knob, the protection frame is fixed, and
the installation is completed;
(vii).Conversely, the saw blade can be removed.
Knob
Saw blade
Saw blade knob
Saw blade
v.Opening and closing of the bottom cover
vi.Battery installation
Type B
Attachment
Knob
( i) .When opening the bottom lid, turn the safety
knobs to the position the arrow point , and
press to open.
(ii).After installing the battery, press the bottom lid
until the bottom cover is closed, and then turn the
safety knobs to the position the arrow points.
( i) .The battery should not be in direct contact
with the handpiece to prevent pollution;
(ii). To install the battery, first install the battery
aseptic transfer ring on the handle, install
the battery into the battery bin through the
battery aseptic transfer ring,press into position,
close the bottom cover, and move the dial
block to lock the bottom cover.
( i) .Align the assembly installation position with the
handpiece,and pay attention to the phase position;
(ii). Turn the knob on the handpiece;
(iii).Release the knob after insertion, jam the drill
or saw adapter and complete installation;
(iv).Converse to detach components.
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
Safety knobs
Hanger
Bottom lid
Handle
Battery aseptic
transfer ring
Battery
0908
Maintenance and cleaning
i.Battery charging
ii.Forward and reverse operation
iii.Trigger operation
( i) .Plug the charger into the power supply, and the
blue green light flashes alternately to indicate
that the self-test is qualified and the charger
enters the standby state;
(ii). Insert the battery into the charger base. The
blue light is always on to indicate charging,
the green light indicates full,and the blue light
flashes to indicate an error.
( i) .When you need forward rotation, please adjust
the knob mark to the corresponding F mark.
(ii). When you need reverse rotation, please adjust
the knob mark to the corresponding R mark.
(iii).Turn the mark to postion S to show stop.
The adjustment of the speed is linear and depends
on the extent of pressing the trigger. When turning
on the trigger for the first time, you should lightly
touch the trigger until it starts, and then press it
slowly until it reaches the maximum speed.
Quick release of trigger triggers the emergency
stop function.
VIII.Operating instructions
This product is maintenance-free. It contains no parts that require
maintenance by the user or manufacturer. However, the manufacturer
recommends that the function and safety of the product be checked
regularly by a professional or hospital technician.It must be checked
once before each operation, and be recorded, analyzed and evaluated
in time to ensure that the product is in good condition and guarantee
the use quality.
X.Cleaning and sterilization
A.Cleaning: the protection of cleaning after use is same as sterilization,
and the handpiece can be wiped clean with gauze soaked in water or
alcohol and then store.
B.Disinfection: Product can be used only when passing inspection after
disinfection and sterilization according to the hospital standards.
Note: Do not soak any part of the medical electric saw drill in liquid.
Recommended handpiece disinfection method
Disinfection
method Operating conditions
and environment
Scope of
application Limitation
Moist heat
sterilization
Sterilization conditions
are generally are:
℃*min,℃*min
or ℃*min
and humid product
High temperature
sterilization
.High temperature
.High humidity
.It is easy to breed
bacteria again when
the product is wet
i:This instrument has no parts that can be disassembled and repaired by
non- professionals. If it fails, please contact the companys after- sales
service department.
ii: If you need technical information about this medical electric drill,
please write to us.。
IX.Maintenance
Commitment
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
Forward and
reverse switch
Trigger
Battery
Charger
This product must be disinfected before use and tested before use after
disinfection.The method is: insert the corresponding battery for the handpiece,
press the trigger gently, the motor shall rotate,switch forward and reverse,
the motor work, or else, the handpiece has a problem, then please stop
using immediately, contact the manufacturer or distributor to send product
back to the manufacturer for maintenance.
% UT; , cycle g) At
0°, 45°, 90°, 135°, 180°
°, ° and °
% UT; cycle and
% UT; / cycles
Single phase: at °
% UT; / cycle
± kV for power
supply lines
% UT; , cycle g) At
0°, 45°, 90°, 135°, 180°
°, ° and °
% UT; cycle and
% UT; / cycles
Single phase: at °
% UT; / cycle
± kV for power
supply lines
Service Guide
-10℃〜+40℃
≤90%
500hPa〜1060hPa
5℃〜40℃
≤70%
860hPa〜1060hPa
-V±％；/Hz±Hz
.V±％
XXXX
XXXX
XXXX
1110
Ambient temperature range
Relatively moderate range
Atmospheric pressure range
Ambient temperature range
Relatively moderate range
Atmospheric pressure range
Charger power
Main power supply (DC)
Transport and
storage
conditions
Equipment
operating
conditions
Production date: Refer to product certificate
Service life: two years short-time running times
Note: According to YY- battery-powered bone tissue surgery equipment
XII.Accessories list
Prepare standard configuration and accessories according to product model
number and product customer need, such as such as saw blade, drill bits,
battery aseptic transfer ring, drill chuck keys,etc.
XI.Transport and storage conditions
Parts List
No.Name Model No. Quantity Note
Handpiece
Battery
Charger
Charger base
Manual
Certificate of conformity
Three certificates
pcs According to
customer needs
According to the
handpiece model
According to the
handpiece model
According to the
handpiece model
pcs
pcs
pcs
pcs
pcs
pcs
XIII.Electromagnetic compatibility
Guidance and manufacturer´s declaration ‒ electromagnetic emission
The RJ-MP(RJ-PS;RJ-PD) is intended for use in the electromagnetic environment specified
below. The customer or the user should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions GB
RF emissions GB
Harmonic emissions
GB.
Voltage fluctuations
flicker emissions GB.
Group
Class A
Not applicable
The RJ-MP(RJ-PS;RJ-PD) uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
The RJ-MP(RJ-PS;RJ-PD) 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.
Guidance and manufacturer´s declaration ‒ electromagnetic immunity
The RJ-MP(RJ-PS;RJ-PD) is intended for use in the electromagnetic environment specified
below. The customer or the usershould assure that it is used in such an environment.
Immunity test IEC test level Compliance level Electromagnetic
environment -guidance
Not applicable
Electrostatic
discharge
GB/T .
Electrostatic
transient / burst
GB/T .
Surge
GB/T .
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
GB/T .
Power frequency
( Hz)
magnetic field
± kV contact
± kV air
± kV wire to wire
3A/m
± kV contact
± kV air
± kV wire to wire
3A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the RJ-MP
(RJ-PS;RJ-PD) requires continued
operation during power mains
interruptions, it is recommended
that the RJ-MP(RJ-PS;RJ-PD) be
powered from an uninterruptible
power supply or a battery.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least %.
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
Aseptic Battery Housing XXXX pcs According to the
handpiece model
1312
kHz～MHz
d=.
MHz～MHz
d=.
MHz～.GHz
d=.
.
.
.
.
.
.
.
.
.
.
.
. . .
Guidance and manufacturer´s declaration ‒ electromagnetic immunity
The RJ-MP(RJ-PS;RJ-PD) is intended for use in the electromagnetic environment specified
below. The customer or the user should assure that it is used in such an environment.
Immunity test IEC test level Compliance
level Electromagnetic environment -guidance
Conducted RF
GB/T .
Radiated RF
GB/T .
V(Effective value)
kHz to MHz
V(Effective value)
MHz to . GHz
V
(Effective value)
V/m
Portable and mobile radio frequency communication
equipment should not be used in any part of
RJ-MP (RJ-PS, RJ-PD), including cables, than the
recommended isolation distance. The distance should
be calculated by the formula corresponding to the
transmitter frequency.
Recommended isolation distance d=.
d=. MHz~MHz
d=. MHz~.GHz
Where:
p-----According to the maximum output power of the
transmitter provided by the transmitter manufacturer,
in watts (w);
d-----Recommended isolation distance, in meters (m)
The field strength of the fixed RF transmitter is
determined by surveying the electromagnetic field a,
and in each frequency range b should be lower than
the compliance level.Interference may occur near
equipment marked with symbols as beside.
NOTE At MHz and MHz, the higher frequency range applies.
NOTE These guidelines may not apply in all situations. Electromagnetic is affected by absorption and
reflection from structures, objects and people.
b 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 measuredfield strength in the location in which
the RJ-MP(RJ-PS;RJ-PD) is used exceeds the applicable RF compliance level above, the RJ-MP
(RJ-PS;RJ-PD) should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the RJ-MP(RJ-PS;RJ-PD).
c Over the frequency range kHz to MHz, field strengths should be less than V/m.
Recommended isolation distance betweenportable and mobile video
communication equipment and RJ-MP (RJ-PS, RJ-PD)
RJ-MP (RJ-PS, RJ-PD) is expected to be used in anelectromagnetic environment with
controlled radio frequency radiation disturbance. According to the maximum rated
output power of communication equipment, the purchaser or user can prevent electro
magnetic waves by maintaining the minimum distance between portable and mobile
radio frequency communication equipment (transmitter) and RJ-MP (RJ-PS, RJ-PD) as
recommended below interference.
Interference test IEC test level Coincidence level Electromagnetic
Environment---Guide
Corresponding to the isolation distance of the transmitter at different frequencies/m
Maximum rated
output power
of the transmitter
For the maximum rated output power of the transmitter not listed in the above table, the recommended isolation
distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency column,
where P is the emission provided by the transmitter manufacturer The maximum rated output power of the machine,
in watts (w).
NOTE At MHz and MHz, the separation distance for the higher frequency range applies.
NOTE These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
from structures, objects and people.
Product
Introduction
InstructionsMaintenance
And Cleaning
Service Guide
Product
Introduction
Instructions
Maintenance
And Cleaning
Service Guide
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