CM-350C User's Manual

CM-350C User’s Manual 1282
CM-350C
User’s Manual
Beijing Render Medical Equipment Co., Ltd.
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Statement
Please do read this page before using the equipment
Our company has the right to modify this User manual without previous noticing the
end users.
No copy or translating version is legal without our company’s permission.
Notice: Please disconnect the power before open the machine casing.

Add.: Room 619 1th Building No. 27 Ke’yuan Road
Daxing Economic Industry Park, Beijing, China.
Tel.: 0086 10 56180066
Fax: 0086 10 60216066
Email: Office@Render.HK
Web.: www.Render.HK
RENDER MEDICAL HOLDINGS LIMITED

419, HARBORNE ROAD, EDGBASTON, BIRMINGHAM,
ENGLAND B15 3LB United Kingdom
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1.Product features:
Class that equipment belongs to: Class I
Type that equipment belongs to: Type BF
Power supply: AC 220V±10% or AC 110V±10%
Power capacity: 1100VA±10%
Equipment application condition: Disconnect with the ground when working at high
frequency.
The Equipment is designed to defense from defibrillation.
General type machine
Working mode: Intermittent loading, working continuously
Non-perpetual installation equipment
2. Symbols
Manufacturer：Beijing Render Medical Equipment Co., Ltd.

Model ：CM-350C
Power supply：110/220V～ 50/60HZ
Power capacity： 1100VA
Classify：Class I Type BF
Working mode: Intermittent loading, working continuously
Fuse：BGXP5×20 5A 3pcs
Highest frequency：400W 500Ω
Packing: Handle with care, upward, keep dry etc.
TYPE BF, The Equipment is designed to defense from defibrillation.
Disconnect with the ground when working at high frequency.
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Power off Power on Power increase Power

decrease
Here is for grounding
3. Technical Parameters
3.1 Environment requirement.
a) Temperature ：5℃～40℃；
b) Relative humidity ：≤80；
c) Barometric pressure ：86.0～106.0kPa；
e) Power supply ：220V±22V/110V±11V， 50/60Hz±1Hz。
Working frequency ：360～512kHz
3.2 Output Rating:
a) CUT： 1W~350W（500Ω）
b）Blend 1 ： 1W～250W（500Ω）；
c）Blend 2 ： 1W～200W（500Ω）；
d）COAG 1： 1W～150W (500Ω）；
e）COAG 2： 1W～80W （500Ω）；
f) BIOPOLAR: 1W~ 70W(100Ω)
3.3 Power supply：5A 220V/110V∽±10％，50/60Hz。
3.4 Machine power dissipation：≤1000VA。（CUT 400W、BIOPOLAR 70W output）
3.5 Transportation and storage
Environment temperature：一 40℃～55℃；
Relative humidity：≤95％；
Barometric pressure：500hPa～1060hPa。
Glossary explanation
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4.1 Peak power system PPS

The initial cut in the cutting process is a particular problem, especially before the start
of high-frequency generator, a cutting electrode is pressed the body tissue. Since at
this time, the surface of the electrode contact with tissue, and make lower resistance.
For example, transurethral resection (TUR) surgery and endoscopic polypectomy are
in this case. In this case, the high-frequency generator provides power should be
higher than usual condition, in order to make the initial cut quickly. Otherwise the cut
point may produce a large area of tissue coagulation necrosis. The electrosurgical
devices equipped with automatic power compensation system, it can identify
low-impedance load, and make high-frequency generator to provide enough power in
short time to ensure the good cutting quality and the required high voltage, which is
the electric arc strength. Besides, low-resistance load can be guaranteed. The device
can limit the average power in a relatively small magnitude, this is an improvement to
prevent the patient suffering thermal damage.
4.2 NEUTRAL ELECTRODE
Neutral electrode is connected with the patient's body relatively large area of the
electrodes to provide a low density of high-frequency current loop, in order to avoid
the human tissues burns and such harmful physical effects.
Other names of Neutral electrode are Plate electrode, or deposited electrode.
4.3 Efficient bipolar coagulation

Efficient bipolar coagulation has the different waveform output with normal bipolar
coagulation.
4.4 Neutral electrode safety system NESSY

Neutral electrode safety system is to monitor the size that neutral electrodes stick on
the patient's body, to ensure the area is bigger than 75%. In this way, it can effectively
prevent the patients’ hurt due to poor contact, poor electric conduction and the small
contact area.
The difference between high-frequency output parameters and the current settings of
the Electrosurgical unit is only caused by the load resistance is too low, for example,
coagulation electrode is too large, the short circuit between the electrode in use and
the neutral electrodes, or equipment failure. The Electrosurgical unit has a neutral
electrode safety system (NESSY), to monitor equipment and electrical connection
between the neutral electrodes and neutral electrode sticks on the patient in right way.
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5. The part names and the functions of machine
5.1 Front panel

The main control section and output section of HF electrosurgical unit are in the front
panel. For security reasons, CUT and COAG functions cannot start simultaneously,
but can be adjusted respectively.
The front panel includes: the power display (green LED), alarm display (red LED),
output display (yellow LED), power switch, power control button, select, CUT
(yellow LED), no blood CUT ( yellow LED), COAG (blue LED), and unipolar
Electrosurgical unit outlet. When use, please refer to the following contents.
5.2 functional areas
5.2.1 failure alarm

When connected, the device automatically checks the performance. If find out the
device or accessories in error, the alarm will sound and the corresponding error
number is displayed with a detected error. If no errors are found, the device will work.
a) The device has a high-frequency output parameters of automatic monitoring
function, it can monitor the actual value and the current set of high-frequency output
of the deviation between the parameter settings. When the deviation is too large to
ensure that the required quality of cutting or coagulation, they will send alarm signals
and / or close the high-frequency generator. Deviations occur or fail to meet
requirements in effect in the case, it shows the output error with the device, allowing
operators to immediately check whether the deviation caused by the device.
b) The deviation between the high-frequency electrosurgical unit output parameters
and the current settings can only be caused by the low load resistance. For example,
the short circuit between the application electrode and the neutral electrode, or
equipment failure.
c) Neutral electrode safety system
The device is equipped with neutral electrode safety system (NESSY), to monitor the
electrical connection between the equipment and the neutral electrode and the neutral
electrode on the patient's right applicator.
When use the neutral electrode with one contact surface, it can only monitor the
electrical connections between the equipment and the neutral electrode automatically.
If the connection is good, the green LED of NESSY lights on, then you can start all
modes of operation. If the connection is interrupted, the red LED of NESSY lights on,
and then you cannot start a unipolar mode of operation.
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When use the neutral electrode with two contact surfaces, not only to monitor the
electrical connections between the equipment and the neutral electrode automatically,
but also to monitor the neutral electrode on the patient's right applicator.
In addition, it can do the automatic continuous measurement to the electrical
conductivity of two contact surfaces on the neutral electrode and the skin of patients,
and automatically compare the measurement results and the high frequency current
strength flowing through the neutral electrode.
If the high-frequency current intensity greater than the corresponding measured
conductivity of the permitted value NESSY will be issued the visual and audible
alarm signal, if the electrical conductivity between the measured neutral electrodes
and the patient is too weak, then you cannot start a unipolar mode of operation.
There are many various neutral electrodes in the high-frequency surgery, but so far
the best ideal neutral electrodes for all applications do not exist. In order to ensure that
when users select the most suitable neutral electrodes with greater freedom, NESSY
provides a flexible security system. It can be in the best way to apply for the users’
neutral electrode.
Warning
For security reasons, only if properly inform all the equipment user about the revision
that users could modify NESSY settings. In addition, modifications of NESSY must
be made appropriate records and archives.
d) If some key on the electrode is on a short circuit or low resistance due to some fault.
(such as the moisture inside the electrode handle )., Or is pressed when connect with
power. The machine will alarm and display the error code when connect with power.
e) If the foot switch happen to a short circuit or Pedal stuck or was pressed in the
process of connecting with power. The machine will sound alarm and display a error
code on the screen when connect with power.
Warning
Only starts after all the function are setted completely.

If try to operate a function area not setted completely. The machine will alarm
intermittently and display a error code.
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f) the machine will test the performance automatically after connecting with the
power. If some function is error, machine will alarm, and display the corresponding
the error code. The machine could identify the below error of the device and relevant
accessories.
--If some key on the front of the panel is short circuit or pressed incorrectly. The
alarm and error code will show where the error is after connecting with the power,
--If some key on the electrode is on a short circuit or low resistance due to some fault.
(such as the moisture inside the electrode handle )., Or is pressed when connect with
power. The machine will alarm and display the error code when connect with power
--e) If the foot switch happen to a short circuit or Pedal stuck or was pressed in the
process of connecting with power. The machine will sound alarm and display a error
code on the screen when connect with power.
--automatically test when the start the machine.
The service will test the performance automatically every start.

The machine will alarm and display the corresponding error code if the find the some
function is error. The machine could identify the below error of the device and
relevant accessories. Check the high-frequency output voltage
--When starting an operation mode, such as cutting or coagulation of soft, if the

high-frequency output voltage deviates from its set value, the device will send a visual
alarm signals and audible alarm signals.
Automatically checks the neutral electrode
--If the connection of the neutral electrode is disconnected, or contact resistance (only
two-sided contact with the surface of the neutral electrode is concerned), the device
will cut off the high-frequency generator, sound the alarm, and shows the error wrong
number
5.2.2 plate detection
Thermal damage caused by the improperly used of the the neutral electrode or non use
the neutral electrode.
If the neutral electrode used improperly, or not even use, there will e dangerous of
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causing the patients’ body great danger of thermal damage on the role point of the
neutral point. Neutral electrode must be close to the surface, and reliably attached to
the patient's body muscle fullness.
Warning
Effective contact surface-Conductivity between the neutral electrode and patient must
be same to the intensity of high-frequency power capacity(high-frequency current).
Effective contact surface means the surface of neutral electrode which can have
conductive contact with the patient's skin during the operation.
Thermal damage surgery caused by improper or faulty attachment using must be

ensured that the accessories are used in good condition. And It can only use the
attachments which can be compatible with or has be tested and qualified by
manufacturers .This applies both to the application of electrodes which include the
cable and plugs and to the neutral electrode also including the cable and plugs.
Using Electrical insulation equipment must be ensured that the insulation function
will not be damaged and overloaded due to high voltage. The using manual contains
the output voltage of high-frequency surgical device should be set in the modes of
cutting and coagulation. The insulation strength can be found in the the technical data
of the equipment. If any other question, please contact the manufacturers of relative
equipments.
Electrode, the electrode handle, cable and plugs, etc. all insulation must be in good
conditions. The risk of thermal injury which caused by wrong output is proportional
to the intensity and time of cutting and coagulation setting in the device.
The intensity of cutting and coagulation should be setting according to the function of
the device. Meanwhile, the time should be just enough. For example, the effect is not
good when the device is setting according to the standard. The reason may be the poor
neutral electrode attachment, poor contact with electrical connectors,faulty cable or
vestigial electrical insulation tissues in the application of electrodes.
Neutral electrode connector
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Monopolar cutting and / or coagulation must use the appropriate neutral electrode.
The neutral electrode should be not only connected with the device, but also sticked to
the patients carefully.
The Electrosurgical Unit is equipped with a neutral electrode safety system (NESSY).
It can automatically monitor the connected condition between the neutral electrode
and the device, and sticking states of patients
Warning
If you use the neutral electrode which has a single contact with the surface, NESSY
only can monitor the electrical connections between devices and neutral electrode, not
monitoring sticking states of patients.
NESSY: neutral socket is a neutral pole pad socket. Its mark means the following
item:
Normal Neutral Electrode
This Electrosurgical Unit suits demand of Chapter 19.101b of GB9706.4-2009,
Isolated from the ground when the neutral pole pad stays in high frequency status.
Based on GB9706.4-2009, our unit suits the demand of BF. Besides, NESSY also
indicates that the neutral pad could cling to the patient’s body during the no-fiber
shake.
NESSY = Neutral Electrode Security System
Neutral Electrode Security System .
Electrosurgical Unit has been set with NESSY, which could monitor the electrical
links between unit and neutral electrode.
When using a whole piece of neutral pad, it could only automatically monitor the
electronic link with pole pad. If the pad is connect well, then green color diode
Neutral indicator light, we could start all of the operation modes.; If the connection
break off, then red color diode neutral indicator light, we cannot start the monopole
mode.
When using two pieces of neutral pad, it could not only automatically monitor the
electronic link with pole pad, but also the cling situation with the patient’s body.
Besides, it could automatically test the electric conductivity between 2 pads and
patient’s body, and makes a automatically compare between the test result and the
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high frequency currency of neutral pad.
If the high frequency currency is much stronger than the permission of the tested
electric conduction, then NESSY will give a visual and audio alarm, then we cannot
start the Monopole operation mode.
There are various kinds of neutral pad, but there is no ideal model which could suit all
users’ demand. In order to ensure each user could use our machine freely, NESSY
supply a flexible neutral pad security system, which could give us the best choice to
use the neutral pole pad.
Security Note: Revising NESSY could only be done after informing all the users.
Meanwhile, NESSY Revising must be recorded and saved.
Before cling the two pieces of neutral pad to the patients’ body, we must first check if
the green color diode Neutral indicator light or not.
Automatically checking of the connection of neutral pad
If the connection is break off after start, or the contact resistance is too big (only for
the divided pad), then the unit will give audio alarm of cutting the current, and give us
the mistake codes.
5.3 Cut
5.3.1
3 Cut Modes: Pure Cut, Blend Cut 1, Blend Cut 2. Every once pressing the button, the
modes changed.
5.3.2
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Power key for increase and reduce.
Switch on the power between 1-40w, pressing once to add or reduce 1w.
Switch on the power between 40-100w, pressing once to add or reduce 5w.
Switch on the power above 100w, pressing once to add or reduce 10w.
Switch on the power above for a long time, it will be add or reduce power quickly.
5.3.3 Power for Cutting
Power for Cutting should between 1-400w (limited 500Ω)

Yellow button on monopole pencil is for Cutting.
Blue button on monopole pencil is for coagulation.
Cutting mode has no function of cruor.
Note: In general type surgery, cutting mini watt mode should be employed, and
enlarge the power gradually if necessary. A depth 2~3cm knife edge should be cut by
a steel knife firstly, and then dip in the blood with gauze, at the same time keep
cutting and Coagulation. When the cut organization shows yellow, it indicates that the
output power is over than the required, you can improve the cutting speed or reduce
the output power. The best effect after cutting is that the organization shows white
with slight yellow, at this time, the hemostasis at good effect and body tissue burnt
slightly.
Cutting under the auto-control of high-frequency voltage (CUT)

Electrosurgical unit device is equipped with automatic power compensation loop
control system to control and adjust cutting, and to ensure that the selected cutting
quality and stable.
The adjustable power limits under the Cutting mode. Because the the electrosurgical
cutting operation mode has adopted high frequency voltage automatic-control
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function, so you don't have to set the power for the cutting quality. Adjustable power
limit is to ensure patient safety, prevent unintended thermal damage to tissue. At the
same time, it can prevent the damage of precise cutting devices, such as needle
electrodes, because if they are contacted with other metal parts when the device has
been initiated and cause high-frequency current, the devices will be easily broken.
This damage may occur in laparoscopic surgery. Don’t mistaken adjustable power
limit as the power setting of conventional high-frequency surgical device. The cutting
quality of the conventional device directly depends on the setting of power.
Cutting is particularly suitable for the human tissue for its poor conductivity.
However, the high frequency voltage of applied electrode, under the cutting model,
can achieve very high value, so cut with good electric insulation instruments, when
operate on poor conductive body tissue. We don’t recommend the cutting function for
Bipolar or quasi bipolar equipment, for their insulation is weak generally and can not
be connected with high voltage. You can adopt the other functions for the bipolar or
quasi bipolar devices.
5.3.4 Blend cut 1

Range of blend cut 1 power output: 1W ~ 250W (load 500Ω)
with peak power system (PPS)
On the unipolar electrode, the yellow button in front is for CUT, the blue button is for
COAGULATION. During the surgical procedures, the doctor use cut or coagulation
according to different human tissue. Press the yellow button for cut, press the blue
button for coagulation. The output power is adjustable, and accompanied by an
audible alert. Generally 1 mm vessel did not need to clamp. Cut and coagulation have
different audio alert to distinguish between the work of cutting and coagulation.
5.3.5 Blend cut 2

Blend cut 2 power range: 1W ~ 200 W load 500Ω
During the surgical procedures, the doctor use cut or coagulation according to
different human tissue. Press the yellow button for cut, press the blue button for
coagulation. The output power is adjustable, and accompanied by an audible alert.
The machine can also work with the endoscope.
5.4 Coagulation function area
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When the displayed value is between 1-40, pressing Increase or decrease button each
time the value will plus or minus 1. When the displayed value is between 40-100,
pressing Increase or decrease button each time the value will plus or minus 5. When
the displayed value is above 100, pressing the buttons will plus or minus 10. If you
press the button continuously, the value will be increase or decrease quickly.
5.4.1 Coagulation 1 ~ 1W ~ 150W (load 500Ω)
Coagulation power output

Coagulation is generally used in vascular coagulation. If we cut off the blood vessels
within 1 ~ 2mm, in order to avoid multiple use of gauze dipped in blood, We can use
the blade electrode to point the ends of blood vessels, then cut off it from the middle
when the color turn into slightly white and yellow.
5.4.2 Electro-Coagulation 2 ~ 1W ~ 80W (load 500Ω)
Since the endoscopic surgery has very strict rule about power output control, it is also
called low-voltage coagulation. Therefore it is mainly used in endoscopic surgery.
Generally been used for vascular coagulation. When cutting off the blood vessels,
which are about 1-2mm or less, the blood vessels can be points by the plane blade in
order to avoiding multiple use of gauze dipping in blood. When the white with a little
yellow color occurs, cut off the vessel from the middle.、
5.4.3 Bipolar coagulation 1-70W（load 100Ω）
It’s a kind of automatic stop function of blood coagulation,the computer monitors the
bleeding tissue to reduce the adhesion. It turns off the output when seeing the blood is
stopped.
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It’s applied in the Orthopaedic, Microsurgery, Brain surgery, etc. Clamping tissue
with the bipolar forceps as less as possible in order to ensure the coagulation effect.
5.5 Rear Panel
The rear panel of the computer high-frequency electrosurgical unit includes: outlet,
fuse block, foot switch jack, protective earth terminal, the product nameplate and fans.
5.5.1 Power Insurance 5 A (BGXP5 × 20) glass insurance, 4A (BGXP5 × 20) glass
insurance. Because when the maximum power output of the electrosurgical unit begin,
there will be the impulse current, 5 A insurance should be used.
5.5.2 AC outlet, rated 5A/220V ~, 50/60 Hz power frequency
5.5.3, The product nameplate.
5.5.4 Footswitch socket: Five pole function foot switch and hand control handle
simultaneously. Bipolar function only under the control of the foot switch.
6. The methods of operation
6.1 Disinfection
Before using this machine, please connect the grounding wire. And also, please
disinfect the head, shank, bipolar forceps, cable and other parts of the application.
Disinfection methods: wipe off dirt with alcohol gauze, then placed in formalin
fumigation liquid container at room temperature, not less than 10 hours.
6.2 Initial operation

During the process of development, production of the high-frequency surgical
equipment, accepted and relative technical requirements and occupational safety and
accident prevention regulations in validity have been considered. Thus, when using
this device according to its purpose, within the allowable range of applications, will
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be able to protect patients, operators and third-party from life and health hazards.
Prior to delivery of equipments, each device's functionality and security shall be
tested by the manufacturer. This is in order to ensure the reliability and security of
equipment performance after transportation and field installation. An operator can
operate the equipment only after field performance test by manufacturer or supplier
performance and introductions of how to operate according to the instructions by the
party responsible for equipment operations.
6.3 Output
6.3.1 Monopole Mode: Using handle pencil to make output. Handle output sockets:
Handle switches and foot switch could be used at the same time effectively.
6.3.2 Bipolar Mode: when using Bipolar output, only Foot Switch could be used.
Note: Handle pencil, Bipolar Needle and other accessories is prohibited to contact
with the liquid directly, nor soaked with medical liquid and other liquids.
6.4 Power On, Checking the initial state.

①No insert the negative pad : After the self-test, the device alarms with Audio and
Video---machine is defective.
② insert the negative pad: Pre-set device into the previous working state, device is
normal.
Note: During working, negative pad must be inserted, otherwise, device cannot work
normally. And give or can not work, and give audio and video alarm.
6.5 The machine has pure cut, no blood cut(blend 1), cautery(blend 2), coagulation1,
coagulation2, high efficient bipolar coagulation modes for the efficient operation:
6.5.1 Cutting 1W ~ 400W (load 500Ω);

Monopole output : Press the yellow button of the handle pencil which have no
coagulation function.
Note: General surgery should be used started from low-power output state, gradually
increase the output power if in need. Using steel knife to open a incision with depth of
2 ~ 3mm, Dipping blood with medical gauze, and at the same time ,cutting along the
incision and stanch bleeding. Yellow color of the incision indicates the power is too
large, can increase the cutting speed or reduce power output. White and light yellow
color indicates the best state of incision, stanch bleeding and less burn.
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Cut under Automatic control of high frequency voltage (CUT)
Electrosurgical unit is equipped with an automatic open and close loop control system
to control and adjust the cut to ensure that the selected cutting quality and stability.
The electrosurgical unit is with high voltage automatic control, thus we do not need to
set the output power of cutting quality. In the cutting operation mode with high
voltage automatic control, so do not set the power of cutting quality. Adjustable
power limit is to ensure patient safety, prevent unintended thermal damage to human
tissue, while preventing the needle electrodes and the like, such as precision cutting
instruments have been activated in case of equipment and other metal equipment in
contact due to high frequency current is too high and cause damage, such damage
may occur in laparoscopic surgery. Adjustable power limit must not be confused with
conventional high-frequency surgical equipment, conventional cutting device is
directly dependent on the quality of the power settings.
Cut especially suit for human tissue with poor conductive. However, the application
of cutting mode on the high voltage electrode can reach very high values, therefore,
performance in the conductive tissues when doing the cutting, we must make sure to
use use good electrical insulation equipment. For the bipolar or quasi-bipolar devices,
cutting function is not recommended, because the devices are generally relatively
small insulated channel, cannot connect with high pressure voltage. For the bipolar or
quasi-bipolar devices, other functions recommended
6.5.2 Bloodless cutting(blend 1)

Bloodless cutting bears PPS (Power Peak System) when its power is within 1W～
250W（Loading 500Ω）. There are two buttons of different colors on the
Monopolar handle: Yellow button: cutting (You can press this yellow button when
you need to cut); Blue button: coagulation (You can press this blue button when you
need to coagulate). You can cut or coagulate when the patient body needs during the
operation.
The output power is adjustable and accompanied by an audible alert.
Generally, vessels, with dimensions of 1 mm or less, did not need to clamp.
Different sounds to distinguish between the work of cutting and coagulation are also
available.
6.5.3 Coagulation one

Generally, when the Coagulation power range is 1W ~ 150W (loading 500Ω), it is for
Vascular coagulation.
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If we cut off the blood vessels of 1 ~ 2mm or less and to avoid multiple dipping the
blood with Gaze, you can use the plane blade ends click both ends of the
vessels. When the color turns white and slightly yellow, please cut off from
the middle. Press this button to choose one of the following coagulation modes.
6.5.4 Coagulation Two

Generally, when the Coagulation power range is 1W ~ 80W (loading 500Ω), it is for
Vascular coagulation.
If we cut off the blood vessels of 1 ~ 2mm or less and to avoid multiple dipping the
blood with Gaze, you can use the plane blade ends click both ends of the
vessels. When the color turns white and slightly yellow, please cut off from
the middle. Press this button to choose one of the following coagulation modes.
6.5.6 Foot Switch

This instrument uses the feet switch and can control all functions. It can be used
simultaneously with the handle under the Monopole mode.
7. Matters need attention:

Handle cable, negative plate cables, and bipolar cables are all
special high-frequency cables. You can also contact the manufacturer to replace them.
7.1 In order to prevent interference to other equipments or the machine shell

being charged for induction, this machine must be grounded, when using.
If the low-frequency current caused from the high-frequency surgical equipment is

too strong or the strong low-frequency current flow from another voltage
source into high-frequency surgical equipment through the patient, then it will
cause electric shock.
7.2 Do not open the cabinet and don’t insert the metal objects into the pore when
using, if there are high-voltage inside the machine. Don’t let the liquid flow into the
machine, so as to avoid accidents.
7.3 Don’t use the knife handle and the electrodes for the "fight the plate experiment",
because the plate is thin or disposable negative plate.
7.4 Accessories in good condition must be used in surgical operation.

Only compatible accessories or eligible accessories tested by manufacture can be used.
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This requirement is not only suitable for application electrodes including cables and
plugs, but also suitable for neutral electrodes including cables and plugs. （6.8.2 aa in
GB9706.4）
When electricity-isolating apparatus is used, it is to ensure that the isolation should

not be overloaded and damaged due to higher voltage. This operation manual
describes output voltage values for all the cutting and electro coagulation operation
modes, their isolating intensities can be found in the technical data of apparatus. If
there is any question, please contact with the manufacturer for technical data.
All the isolations of electrode, handle of electrode, cable and plug etc. should be kept
in good conditions.
7.5 Polar Plate (Neutral electrode)
The whole area of polar plate (electrode plate) must closely attach to the body of
patient (beneath buttocks), and should be as close as possible to operation area.[ 6.8.2
bb）1）in GB9706.4]
Effective contact surface i.e. electric conductivity between neutral electrode and
patient should be equal to high frequency capacity applied namely the intensity of
high frequency current. Here, effective contacting surface means neutral electrode
surface contacting electric conduction contacting with patient’s skin during
operations.
If it is misused or even not used, then there would be a great risk to tissues of human
body by accidental heat trauma at point of neutral electrode as well as on the other
parts of patient.
There are two types of plate, metal polar plate, one-off skin application plate.
The metal polar plate must be packed in two layers. It should be wet by saline before
using. The whole area of polar plate must closely attach to the body of patient
(beneath buttocks), and should be as close as possible to operation area, in order to get
the good return circuit. One-off skin application plate electric conduction should be
gumming to the body of the patient (beneath buttocks).
7.6 Patient should not touch any metal parts (such as: operating-table, bracket etc.)
that are connected with grounding or the metal parts with considerable capacitance of
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grounding. Thus, it is suggested to use antistatic plate.【 6.8.2 bb）2）in GB9706.4】
7.7 To avoid skin-to-skin contacting (i.e. arm to body of patient), put a piece of dry
gauze in between. [6.8.2 bb）in 3GB9706.4]
Between the contacting points of four limbs or skin while lying, there should be put a
piece of dry gauze in between to isolate them each other.
7.8 When the high frequency surgical equipment and the physiological monitor are
used for the same patient, all monitoring poles shall be kept as far as possible from the
surgical pole. It is not recommended to use the needle-style monitoring pole. In any
case, it is recommended to use the monitoring system with high frequency current
limiter.
In any case it is recommended to use with high-frequency current limiter monitoring
system. [6.8.2 bb）4）in GB9706.4]
Do not use the electrocardiogram (ECG) electrodes within 15 com away from the
surgical area
7.9 The cables of the surgical pole shall be kept away from the patient or other cables.
For those surgical poles are not used temporarily, they shall be placed away from the
patient. [6.8.2 bb）5）in GB9706.4]
Like the scalpel, high-frequency surgery is a potential risk if Negligence, it should
always be cautious when using the cutting electrode and coagulation electrode, put it
far away from the patient or other staff during intermittent.
It is forbidden to make the hilt, bipolar forceps and other accessories contact the
solution directly, especially to immerge them in the solution or other liquids.
7.10 In the surgery process, when the high frequency current flows through the
smaller part of the body, the bipolar technology is preferred to avoid unnecessary
concretion.
20
human tissue, smallest diameter area always feel the heat firstly. If the high frequency
current flows through the same diameter in a long distance (a), the tissue will be
coagulated in the entire distance. If the diameter of tissue which is near by the
coagulation point is smaller than the diameter of the coagulation point, then, in the
area nearby point (b) can also be coagulated.
Any time the doctor needs to to ensure that high-frequency current does not flow
through a small organization or small-diameter vascular
7.11 The target shall be achieved at a power output as low as possible. [6.8.2 bb）7）
in GB9706.4]
7.12 In the normal setting mode, if the output is lowered obviously or the bistoury
can’t work normally, it indicates that poor contact or improper use occurs on the pole
pads. [6.8.2 bb）8）in GB9706.4]
7.13 If the surgery is made on the chest or head, the flammable anesthetic, giggle gas
and oxygen shall not be used unless the anesthetic gas is exhausted or the
anti-anesthetic equipment is employed. Before the high frequency surgery is carried
out, the solvent of the flammable detergent, disinfector or bond shall be vaporized out.
Before using the bistoury, wipe the flammable fluids remained on the patient’s lower
body, body concave (e.g. bellybutton) and body cavity (vagina). Great attention shall
be paid on the fire risk due to the inside gas. Some materials (e.g. absorbent cotton
and gauze filled with oxygen) may be ignited by the spark produced by the device.
[6.8.2 bb）9）in GB9706.4]
The application electrodes of high frequency surgical equipment make

sparks or arcing during the operation which can ignite flammable liquids, gases or
vapors. During the high-frequency operation, we must ensure that
the use of anesthetic, skin cleansers and disinfectants are all non-flammable. We also
must make ensure that no flammablegas is in the body, otherwise there is risk
21
of explosion
Therefore, before surgery, We must remove flammable gases and / or use CO2-blown
spray the affected body cavity, to remove flammable gas.
During the surgery of Transurethral resection (TUR), in the electric arc between
the removal ring and the wash liquid, the H2O molecules crack into H2
and O2. These gases will be gathered at the top of the bladder, making
a high-explosive gas mixture. If we do the surgery in the mixture, there may be a risky
explosion.
7.14 For patients who are with pacemakers or pacemaker electrode, there may be a
danger, because it may interfere with the work of the pacemaker or the pacemaker
may be damaged,. If anything is abnormal, we should go and find
a cardiologist to get help. [6.8.2 bb) 10) in GB9706.4]
7.15 The interference caused by High-frequency surgical equipment may have bad
effect on the work of other medical electrical equipment. [6.8.2 bb) 11) in GB9706.4]
High-frequency surgical equipment usually have a high frequency voltage and current
which make interference with other electronic devices. When installed sensitive
electronic equipment in the operating room, we need to consider this issue. In
principle, sensitive electronic equipment should be placed as far as possible away
from the high-frequency surgical equipment, especially high-frequency
current transmission
cables. In addition, the high-frequency current cable works as
the radio antenna cable, so its length should not exceed the actual needs, and
certainly not parallel to the sensitive electronic equipment, or be too close.
Taking into account its interference for the sensitive electronic devices, this device
has been equipped with a dedicated generator. Compared with
conventional high-frequency surgical equipment, it produces a relatively low level of
interference.
22
7.16 Users should check the accessories before using the machine every time,
especially check the electrode cable insulation. [6.8.2 dd in GB9706.4]
7.17 Equipment under normal operating conditions:
7.17.1 Pencil shank has no fixed number of uses. It may be damaged once it exceeds
its life. Pencil head can be use repeatedly.
7.17.2 Metal negative plate can be used repeatedly while disposal negative plate can
be used only once. When the wire of the negative plate is used repeatedly, please do
not use it more than 3 months. Once the plate surface damages, it should
be immediately replaced. It may be damaged at any time once it exceeds the limit of
usage.
Please make sure to clean the connector usually which connects the plate wire and
plate.
Make sure that we clean the conducting resin or liquid which flows into the connector
on time to avoid the damage to the machine.
7.17.3 There is no fixed times of uses for the cable of the bipolar forceps and cable
plugs. They may be damaged once they exceed the usage life.
Once the insulation of the bipolar drops, it should be replaced immediately.
7.17.4 Foot switch is designed for long-term usage.
7.17.5 Once there is any damage for the power cable of the main unit, it should be
replaced immediately.
7.18 After each operation, attachment should be cleaned carefully by absorbent

cotton, gauze dipped in salt water or alcohol, and then safe keeping.
The prepared device should be placed in room which has no corrosive gas and good
ventilation.
Make sure that the main unit and attachment are working well and effective before
each surgery.
7.19 Disassemble parts and its manual for assemble and disassemble
The replacement manual for consumable material
23
7.19.1 Hilt and blade

If the hilt button is damaged (e.g. hilt blocked) and the cables are damaged, they shall
be replaced immediately.
The hilt is made of special high frequency cable and shell and the head is made of
stainless steel. The hilt cable plug and the bistoury output socket are molded and the
three-core plug is inserted in to the output socket in a parallel method. When
disassembling the hilt, draw the plug out of the socket by holding its rear end. The
head is connected to the hilt and the rear end of the head is aligned and inserted to the
socket. Remove the head and draw it out by holding its middle part.
7.19.2 Skin application plate, plate lead and connection of the machine
If there is any evidence that the burning occurs on its surface, poor contact between
the plug and the socket or false cable connection, they shall be replaced immediately.
Cables of metal polar plate, one-off skin application plate, and tow bipolar plates, skin
application plate leads are made of special high frequency cable. At rear parts of
metal polar place and one-off skin plate, there is a rectangular place for sockets for
inserting skin application plate lead, pull it out in reverse direction. The plug for
connecting skin application plate blade and machine is Φ6.5mm, insert Φ6.5mm plug
into the socket of PATILENT PLATE, and Pull it out in reverse direction.
7.19.3 Connection between footswitch and Machine
Footswitch is in normal open; replace lead when it is broken
The footswitch is made of special high frequency cables. There is foot pedal socket at
rear part of machine. A gap is located at the front of plug, level the gap of socket and
insert it into the socket by pushing it rear end. Remove it by holding the front part of
plug and press down the square lock and take it out.
7.19.4 Fuse
The fuse is installed on the back panel of the equipment, and integrated with power
supply socket , Pull off the power cables, pull fuse fixture slightly with hand, take
fuse box out for replacement. Insert the replaced fuse parallelly into fuse fixture to
finish replacement
7.19.5 Power supply Lead
If the two terminals of the power cable has poor contact or are damaged, or the
surface of the cable is damaged, they shall be replaced immediately. For the power
cable, one end is a round external three-core power plug and the other end is a square
internal three-core main unit power plug, which is inserted into the power socket at
the back panel of the equipment. To remove it, draw it out holding its head.
7.19.6 Dustproof cover of fan
The machine is equipped with a fan for lowering temperature, the fan is fixed with a
dustproof cover, and there is much of dust accumulated after operating for a long time.
24
There are 4 positioning locks within dustproof cover, hold one side of dustproof cover
with hand, take off it with force, wash and clean it with sponge, put it under natural
condition for drying after cleaning, and replace it within dustproof cover, relocate it
into the original place parallelly
7.20 Safety regular maintenance The main unit shall be run in unloaded status at the
normal temperature not less than 20 hours every month, check if the accessories run
normally and effectively.
7.21 The main unit shall be checked by professional technician at least four times
every year. mainly including removing dust in the machine, checking if the machine
works normally, safety inspection, condition of isolation, and checking if the
accessories are correct and effective. . .
7.22 When there are sound prompts such as, no power output or audio and light alarm
during operation of this machine, the machine cannot operate normally, please stop
the machine and check if high voltage fuse is damaged. If the high voltage fuse is not
damaged, please check if skin application plate and cable are in good condition;
replace them if they are damaged.
7.23 ★ Note that the product’s plug shall be kept in connection with the power
supply in a good status when it runs with power output.
★ To avoid accident, never leave the product unloaded running in the surgery
process.
7.24 In case that the power supply doesn’t comply the requirements (220V±10％,
supply frequency 50Hz ), please use regulated power supply. Note that when it runs
with power output, the product’s plug shall be kept in connection with the power
supply in a good status .In case that the power supply doesn’t comply the
requirements (220V±10％, supply frequency 50/60±1Hz ), please use regulated
power supply. To avoid accident, never leave the product unloaded running in the
surgery process.
7.25 It is crucial to check the ground wire of the power is reliable before start up the
product. Before using the product, please make sterilization on its head, hilt, bipolar
forceps, cables and other working parts.
Method of Sterilization: First, wipe off the filth on all parts with the alcohol gauze;
then fumigate them in formalin solution at the normal temperature not less than 10
hours.
7.26 Unintentional thermal damage to human body

It has kinds of risks to patients, doctors and surrounding during high frequency
25
surgical operations. To avoid the risks during the operation, surgeons and their
assistants shall be aware of the risks and follow the rules so that can prevent. The
following explains the risks and the rules in detail.
7.26.1 Due to the High frequency leakage caused thermal damage

During the operation, patients will inevitably conduct high-frequency current to
ground. If during that time, patient contacts one conductive object, then it will
produce high frequency current between patient and the object, which shall leads the
patient to thermal damage.
Not only metal, but the wet cloth is conductive object.
Electrical insulation surface Earthing Operation Table
Warning
In the high frequency surgery, it shall isolate the patient from conductive objects. The
black cover on operation table has conductivity which can split partial electronic
charge, so during the operation, to be safety, it shall sheet an insulating layer between
patient and black cover, like died cloth.
If the insulating layer is getting wet during the operation due to sweating, irrigation,
urine and etc., it shall adapt water-proof plastic layer and use catheter.
7.26.2 Due to turning on the machine accidentally caused thermal damage
If you turn on the machine accidentally, and electrode conductor contact with the
patient directly or a damp cloth contact with patients indirectly, then it may result in
burning patients.
For instance, the following reasons may lead to turn on the machine inadvertently:
● Press the footswitch inadvertently
● Press the manual control switch inadvertently
● Fault in footswitch, manual control switch or cable
26
●Conductive liquids (such as blood, amniotic fluid, urine, saline, wash fluid, etc.) into
the footswitch or manual control switch
● internal fault in high frequency unit
In order to prevent patients from thermal damage due to turning on the unit
inadvertently and pay more attention to the following usage rules:
●Never put electrode on patient’s body or aside them casually and never let electrical
conductor, or wet cloth contact with the patient indirectly.
●The cables of the surgical pole shall be kept away from the patient or other cables.
●Set sound signal can be recognized easily, which could prompt working condition of
high-frequency unit.
●In some operations, such as endoscope surgery, even if they do not work, cutting
electrode or forceps have to contact with the patient inevitably. At that time, surgical
shall use this instrument with great care.
The instruments shall be turn off when be removed from the body. Otherwise, all the
body parts that contact the instruments will be burned. Therefore, when that kind of
mistake happen surgical shall immediately cut off the power of high-frequency unit
and try to remove electrodes from human body.
7.26.3 Thermal damage caused by device output error

The risk of thermal damage is proportional to the intensity and time of cutting or
coagulation settled on the device.
The intensity of cutting or coagulation should be set according to the purpose, and in
the mean time, actuation duration should be just enough.
For example, if the result is not good enough when you set it according to the
standard setting, the reason may be the neutral electrode doesn't attach well, poor
contact in electrical connectors, faulty cable, or electrical insulation tissue have
residue on the application electrodes. So, please check before increasing the power.
7.26.4 thermal damage caused by the hot electrode

In the process of cutting or coagulation, electrodes will get very hot due to arc and
tissue's high temperature. Shortly after cutting or coagulation, if the electrode that still
very hot is exposed to human tissue, then it may accidentally burn tissue. In
endoscopic surgery, such as tubal coagulation in pelvic surgery or endoscopic
resection of polyps, we must pay special attention to this problem.
7.26.5 Nerve and muscle stimulation

A high surgical risk that has been known is unintentional nerve and muscle
stimulation to the patients. This stimulation comes from the effect of low-frequency
27
current ; and low-frequency current may be caused by the low-frequency current

source, or by the arc between the application electrode and the patient's body
tissue.AC over 300KHZ will not stimulate the nerves and muscles.
In the process of cutting, strong coagulation or jet coagulation, the arc inevitably
caused between the tissue and the application electrode will rectified part of high
current ,producing a low-frequency current component that will be highly modulated
to a certain extent .This current component will stimulate the body parts that is
vulnerable to electrical stimulation, such as nerve and muscle. The results will cause
severe spasticity, or muscle contraction to some extent.
When implementing high-frequency operation on human body structure that can be
affected by electrical stimulation, the contraction of the affected muscle must be
considered. For example, when implementing the bladder endoscopic surgery near the
obdurate muscle nerves ,or an operation in the facial nerve area, this will happen.
8. output data
8.1 cutting, no blood cutting, fulguration, coagulation, coagulation
8.2 High-frequency leakage current
8.2.1 neutral electrode (deposited plates) should be isolated from ground at high
frequencies, and application part must be isolated from ground both in the high and
low frequency , to ensure that the high-frequency leakage current passing thru 200Ω
resistor from each electrode to ground will not exceed 150mA when you do
experiment as per the following the requirements.
Must use the following test to verify compliance with requirements:

In the test, the device must set electrode cables and electrodes according to the layout
shown in Figure 102 GB9706.4 .
Keep the electrode away from the cable by 0.5m, place them on the insulated surface
which is 1m above the ground or any conductor surface , output port unloaded, and all
metal housing of Ⅱ type equipment and internal power supply device must be
grounded.
Device with insulated enclosure must be placed at a grounded metal plate whose area
at least equal to the device's basel area (see Figure 104 below).
Equipment operates at each work's maximum output setting, measuring the
28
high-frequency leakage current from each electrode in turn.
8.2.2 bipolar electrode application:
Any application part specially designed for the use of bipolar must be isolated from
ground and other application part, no matter at high and low frequencies.
9. special parameters in order to use it safely
Continuous leakage current and patient auxiliary current
leakage current CF style
In the Normal condition In the single-fault

condition
Earth leakage current ≤0.5mA ≤1mA
≤0.1mA ≤0.5mA
Enclosure leakage
current
Patient leakage current ≤0.01mA ≤0.05mA
Patient leakage current ≤5mA ----------

when the voltage is
applied to the working
parts
patient dc ≤0.01mA ≤0.05mA

auxiliary
current
ac ≤0.1mA ≤0.5mA
High frequency ≤150mA -------------

leakage current
29
10、The measures which must be taken when the equipment comes into use
10.1 please connect the additional ground wire. The end of the power cable which is
connected to the network power supply has three cores ,and the long one in the middle
should be connected to earth when the product is used.
10.2 Before using the product ，please make sterilization on its head, hilt, bipolar
forceps, and the working part of the high frequency cable.
Method of Sterilization: First, wipe off the filth on all parts with the alcohol gauze;
then fumigate them in formalin solution at the normal temperature not less than 10
hours.
11、Transport & Storage
11.1 Transport: As per the purchase contract.
11.2 Storage: The packed unite should be kept in a ventilated room without any
corrosive gas (Temperature: -40℃~ 55℃, RH≤95%).
10. Common Problems and Solutions

1. Common Problems: The machine has the error recognition, error code is as follows:
ERR-1 Return factory, maintenance
ERR-3 2 keys pressed
Description: There are two keys pressed simultaneously.
ERR-4 Mode error
Description: mode errors, such as: bipolar mode, press the cut button.
ERR-5 Operation Error
Description: There is a working key then press another key work.
ERR-7 Self Test Error
Description: When a key is pressed or there is interference signal around
ERR-8 Plate to monitor
Description: plate is not connected
2. Solutions：
ERR-3 : Check the keys of pen knife and pedal, reset. Or change pen knife and
pedal.
ERR-4: Make sure that the current mode (Bipolar bipolar light for Bipolar bipolar
mode, light off for Unipolar mode)
ERR-5: attention the operate
30
ERR-7: Check all accessories

ERR-8: Check the plate connect closely with the machine, Plate and the plate
cable connected close, Do not reuse disposable plate, check the circuit plate is in close
contact with the patient.
NOTE: circuit plate is not contact with the patient. Shows ERR-8
SHOWS ERR-1，ERR-2，ERR-6, please Return factory to repair, non-professionals
prohibit to repair!

Add.: Room 619 1th Building No. 27 Ke’yuan Road
Daxing Economic Industry Park, Beijing, China.
Tel.: 0086 10 56180066
Fax: 0086 10 60216066
Email: Office@Render.HK
Web.: www.Render.HK
RENDER MEDICAL HOLDINGS LIMITED

419, HARBORNE ROAD, EDGBASTON, BIRMINGHAM,
ENGLAND B15 3LB United Kingdom
31

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CM-350C User’s Manual 1282

Beijing Render Medical Equipment Co., Ltd.

Please do read this page before using the equipment

Beijing Render Medical Equipment Co., Ltd.

RENDER MEDICAL HOLDINGS LIMITED

Manufacturer：Beijing Render Medical Equipment Co., Ltd.

TYPE BF, The Equipment is designed to defense from defibrillation.

Disconnect with the ground when working at high frequency.

Power off Power on Power increase Power

Here is for grounding

4.1 Peak power system PPS

4.2 NEUTRAL ELECTRODE

4.3 Efficient bipolar coagulation

4.4 Neutral electrode safety system NESSY

5. The part names and the functions of machine

5.1 Front panel

5.2 functional areas

5.2.1 failure alarm

Only starts after all the function are setted completely.

--automatically test when the start the machine.

The service will test the performance automatically every start.

--When starting an operation mode, such as cutting or coagulation of soft, if the

5.2.2 plate detection

Thermal damage surgery caused by improper or faulty attachment using must be

Neutral electrode connector

high frequency currency of neutral pad.

Automatically checking of the connection of neutral pad

Power key for increase and reduce.

5.3.3 Power for Cutting

Power for Cutting should between 1-400w (limited 500Ω)

Cutting under the auto-control of high-frequency voltage (CUT)

5.3.4 Blend cut 1

5.3.5 Blend cut 2

5.4 Coagulation function area

5.4.1 Coagulation 1 ~ 1W ~ 150W (load 500Ω)

Coagulation power output

5.4.2 Electro-Coagulation 2 ~ 1W ~ 80W (load 500Ω)

5.4.3 Bipolar coagulation 1-70W（load 100Ω）

5.5 Rear Panel

6. The methods of operation

6.2 Initial operation

6.4 Power On, Checking the initial state.

6.5.1 Cutting 1W ~ 400W (load 500Ω);

Cut under Automatic control of high frequency voltage (CUT)

6.5.2 Bloodless cutting(blend 1)

6.5.3 Coagulation one

6.5.4 Coagulation Two

6.5.6 Foot Switch

7. Matters need attention:

7.1 In order to prevent interference to other equipments or the machine shell

If the low-frequency current caused from the high-frequency surgical equipment is

7.4 Accessories in good condition must be used in surgical operation.

When electricity-isolating apparatus is used, it is to ensure that the isolation should

7.5 Polar Plate (Neutral electrode)

grounding. Thus, it is suggested to use antistatic plate.【 6.8.2 bb）2）in GB9706.4】

The application electrodes of high frequency surgical equipment make

7.17 Equipment under normal operating conditions:

7.17.4 Foot switch is designed for long-term usage.

7.18 After each operation, attachment should be cleaned carefully by absorbent

7.19.1 Hilt and blade

7.26 Unintentional thermal damage to human body

7.26.1 Due to the High frequency leakage caused thermal damage

Electrical insulation surface Earthing Operation Table

7.26.2 Due to turning on the machine accidentally caused thermal damage

CM-350C User's Manual

CM-350C User's Manual