by Mindray authorized personnel.

Return Policy
 the electrical installation of the relevant room complies
Rigid Endoscope
with the applicable national and local requirements, Return Procedure
The device bears CE mark indicating its conformity with the
M 01000A/M 01030A/M 01000 and Product Description
provisions of the Council Directive 93/42/EEC concerning In the event that it becomes necessary to return this device
/M 01030  the device is used in accordance with the instructions
The product is composed of the following parts:
medical devices and fulfills the essential requirements of or part of this device to Mindray, the following procedure
for use.
Rigid Endoscope Annex I of this directive. should be followed:
The device complies with the requirements of EN/IEC Return authorization: Contact the Customer Service
60601-1-2 “Electromagnetic Compatibility – Medical Department and obtain a Customer Service Authorization
Electrical Equipment”.  It is important for the hospital or organization that number. This number must appear on the outside of the
th
Operator's Manual employs this device to carry out a reasonable Figure 1Rigid Endoscope
© 2018 Nanjing Mindray Bio-Medical Electronics Co., Ltd. All shipping container. Returned shipments will not be accepted
rights Reserved. service/maintenance plan. Neglect of this may if the number is not clearly visible. Please provide the model
For this Operator’s Manual, the issued date is 2018-05 result in machine breakdown or personal injury. number, serial number, and a brief description of the reason 1. Objective lens 2. Eyepiece
(Version: 2.0). for return. 3. Beam channel interface 4. Richard-wolf beam
Freight policy: The customer is responsible for freight
(used for the ACMI system) channel connection adapter
Intellectual Property Statement  This device must be operated by skilled/trained
charges
arges when this device is shipped to Mindray for service
system
(this includes customs charges).
NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., clinical professionals.
Return address: Please send the part(s) or device to the 5. Storz beam channel 6. Lens
LTD. (hereinafter called Mindray) owns the intellectual
address offered by the Customer Service Department. connection adapter system
property rights to this Mindray device and this manual. This Warranty
manual may refer to information protected by copyrights or
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL Contact Information
patents and does not convey any license under the patent Safety Instructions
OTHER WARRANTIES, EXPRESSED OR IMPLIED,
rights or copyright of Mindray, or of others. Manufacturer: Nanjing Mindray Bio-Medical Safety Markings
INCLUDING WARRANTIES OF MERCHANTABILITY OR
Mindray intends to maintain the contents of this manual as Electronics Co., Ltd. Markings Meaning
FITNESS FOR ANY PARTICULAR PURPOSE.
confidential information. Disclosure of the information in this Address: 666# Middle Zhengfang Road, Jiangning, Indicates the existence of hazards, which, if
manual in any manner whatsoever without the written 211100 Nanjing, Jiangsu, P.R.China not avoided, may cause death or serious
Exemptions
permission of Mindray is strictly forbidden. Tel: +86 25 66082666 injury.
Release, amendment, reproduction, distribution, rental, Mindray's obligation or liability under this warranty does not Indicates the existence of potential
Fax: +86 755 26582680--26666
adaption and translation or any other derivative work of this include any transportation or other charges or liability for hazards, which, if not avoided, may cause
manual in any manner whatsoever without the written direct, indirect or consequential damages or delay resulting personal injury or product/property loss and
permission of Mindray is strictly forbidden. from the improper use or application of the device or the use EC-Representative: Shanghai International Holding damage.
of parts or accessories not approved by Mindray or repairs by Corp. GmbH (Europe) "Caution" indicates an issue that should be
, , are the trademarks, people other than Mindray authorized personnel. Address: Eiffestrasse 80, 20537 Hamburg, noted. Please read the manual carefully
registered or otherwise, owned by Shenzhen Mindray This warranty shall not extend to: Germany before using the system.
Bio-Medical Electronics Co., Ltd. All other trademarks that  Malfunction or damage caused by improper use or Tel: 0049-40-2513175
2513175 CF type application part
appear in this manual are used only for informational or man-made failure.
CE logo complies with medical device
Fax: 0049-40-255726
255726
editorial purposes. They are the property of their respective  Malfunction or damage caused by unstable or
Directive EEC.
owners. out-of-range power input.
Indicates that the product may be sterilized
 Malfunction or damage caused by force majeure
with high pressure and high temperature,
Responsibility on the Manufacturer Party such as fire and earthquake.
including steam sterilization.
 Malfunction or damage caused by improper
Contents of this manual are subject to change without prior Manufacturer
operation or repair by unqualified or unauthorized
notice. Date of production
service people.
All information contained in this manual is believed to be
 Malfunction of the device or part whose serial
correct. Mindray shall not be liable for errors contained herein Temperature limitations
number is not legible enough.
or for incidental or consequential damages in connection with
 Others not caused by device or part itself.
the furnishing, performance, or use of this manual. Storage and transport humidity

Mindray is responsible for the effects on safety, reliability and

P/N: 046-010632-00(2.0) Storage and transport pressure
performance of this device, only if:
 all installation operations, expansions, changes,
modifications and repairs of this device are conducted

Sterilization is required before each use
IPX7 IPX7 waterproofing rating
WEEE label
The following definition of the WEEE label
applies to EU member states only: the use
of this symbol indicates that this product
should not be treated as household waste.
By ensuring that this product is disposed of
correctly, you will help prevent bringing
potential negative consequences to the
environment and human health. For more
detailed information with regard
returning and recycling this product, please
consult the distributor from whom you
purchased the product.
Intended Use
 The product can be used for the following purposes
only.
 It is used in the operating room of hospital.
The product is used for the observation and imaging of
minimally invasive surgery in the abdomen, used in medical
institutions
Contraindication: It is prohibited to use this product in
circumstances not suitable for endoscopic therapy.
Safety Warning
 The product must be operated by a trained operator
with the necessary knowledge and experience to do
so. All operators should read the manual carefully
before using the product.
 The product must be used in the manner shown
within the manual. Any operations of the product
that do not comply with the instructions, warnings
and precautions may result in risk and other serious
consequences. Check the product and
accessories before use to ensure they
functioning correctly.
 Ensure that all devices operating nearby meet
related requirements for electromagnetic
compatibility (EMC).
 This product cannot be safely used in a magnetic
resonance imaging environment.
 All devices that connect with this piece of equipment
must be certified with the designated IEC standards
(such as IEC 60601-1 Medical Device Standards).
The operator is responsible for connecting and
configuring additional equipment and that the
system is IEC 60601-1 compliant. For any
questions, please contact the supplier.
 Non-sterile components must be disinfected and
sterilized before use.
to  Improper use or maintenance of the product or use
beyond the intended purpose may increase risks to
patients and result in premature wear and tear of
the product.
 After the product has been cleaned, disinfected, and
sterilized the product shall be cooled down before
use. Do not use the product at high-temperatures.
 High energy radiated light may be transmitted from
objective lens of the endoscope, please do not look
directly at the light outlet in case of causing eye
burn.
 Do not modify this equipment without authorization
of the manufacturer
 Reagents and equipment applied for cleaning,
disinfection and sterilization procedures must be
checked and accepted, and the intended use must
be ensured within the period of validity.
 Protect the product's original packaging in case the
product needs to be returned to the factory for
repair.
 Bending, twisting, pulling or compression may
easily damage the product. These types of actions
may further damage the optical elements and
results in surgical failures. Note: Only use the
product in designated environments.
 When disposing of the product and its accessories
do so strictly follow local regulations.
its
Getting Started
are
Installation
According to guide beam interface forms, select the
appropriate adapter, connect the cold light source beam into
the endoscope-guided beam interface.
Testing
Before cleaning, disinfecting, or sterilizing the product, test
the product using the following steps:
 Testing of fiber optics
1. Point the far end of the endoscope at a bright
light source (not a cold light source) like an
indoor lighting source and move the endoscope,
and then bring the near end up to the eye.
2. The brightness of the fiber optics will change, in
the even that the fiber has been damaged or
broken. A single broken fiber will not cause any
danger. If 10-20% of the fibers become broken, it
is suggested you send the endoscope in for
repair.
 Inspection of glass surfaces
1. Make a visual inspection of lens surfaces,
ensuring they are both clean and smooth.
2. If damage is found during inspection, the
damage may be remedied by consulting the
"Common Faults and Solutions" section
 Inspection of lens surfaces
1. Make a visual inspection of lens surfaces,
ensuring they are both clean and smooth.
2. If bends, depressions, cracks, or other forms of
damage are found during inspection, it is
suggested that you send the endoscope in for
repair.
 Using this product with any sharp edges or broken
surfaces will put patients at risk. So before each
use, please check to ensure there are no
unintended rough surfaces, sharp edges or
protrusions which may cause harm.
 Do not use the fiber optics if the glass surface has
been damaged or if there are stains on it that cannot
be removed with cleaning. Return damaged
products to the manufacturer or authorized repair
center. Information about authorized repair centers
may be obtained from the manufacturer.
Disassembly of Component
Remove all adapters.
Guide on Use with Other Medical Products
This product can meet the requirements of type CF
applications. If the medical appliances or accessories being
used with this product meet CF requirements, then the whole
endoscopic system can meet the protection requirements for
CF application.
Medical appliances
pliances or accessories used with this product
should at least meet the requirements for BF applications.
Products with this symbol meet
requirements for CF applications.
 The beam connection port and the endoscopic
metal hood on the front of the cold light source will
have a surface temperature of over 41 ° c after a
long period of use, avoid contact with these parts to
avoid burns.
 Using magnetic resonance imaging (NMR),
endoscopic and accessories can lead to danger and
produce man-made artifacts;
s; please follow the
manufacturer's instructions and safety precautions.
 This product may be used in coordination with a
laser and high frequency surgical instruments,
pneumatic or electro-hydraulic
hydraulic endoscopic
accessories in many therapeutic areas. Please
follow the safety instructions of the product and any
accessories used with the product.
 If the product is used together with an endoscope
camera system or a cold light source which fails to
meet the requirements for BF or CF applications,
the possibility of current leakage may increase.
 Before use, the operator must check the equipment,
cables and accessories, to ensure they work
properly and safely.
 Risks associated with the use of a cold light source:
 Cause irreversible damage to a patient's tissues or
unnecessary coagulation.
 Cause the combustion or burning-out
burning of surgical
instruments (such as surgical drapes, plastic
materials, etc.).
 If the light source is damaged during use, it may be
a danger to patients. Therefore, a standby light
source should be provided or a light source with
extra bulbs is used.
 Safety precautions:
 Avoid using strong light sources for an extended
period of time.
 Use the minimum brightness required to illuminate
the target area.
 Do not let the far end of endoscope or the beam
connectors touch a patient's tissues, combustible
materials, or heat-sensitive materials.
 Do not touch the far end of the endoscope or the
beam connectors.
 Prevent the surface of the endoscope's far end from
becoming contaminated, especially the light
the emitting surface.
 The applied part is the metal part of rigid
endoscope.
Routine Maintenance
Surgery Cleaning and
Disassembly Sterilization
pretreatment disinfection
Endoscope reprocessing steps are as follows:
The endoscope should be cleaned, disinfected and sterilized
before and after each use; otherwise it may cause bacterial
infection. The disinfection and sterilization methods should
be used only after they are validated by the application unit.
Disassembly
The endoscope should be removed from the camera system
before cleaning, disinfection, and sterilization while the beam
connectors should be pulled out of the endoscope. If the
endoscope is cleaned, disinfected, and sterilized without
disassembly, it may fail to reach the desired effect.
Pretreatment of Operation Room
The time from cleaning and disinfection to operation should
not exceed 6 hours; otherwise deep stains from operation will
increase the difficulty of cleaning or result in ineffective
disinfection or the corrosion of the stainless steel.
 Immerse endoscope into demineralized or distilled
water. Wipe the surface soil of device with disposable
soft clothes.
 Put the device in the fixed tray to avoid be damaged.
Cleaning and Disinfection
Manual cleaning
1. Cleaning
 Disassemble adapter and immerse the adapter and
endoscope into the neutral multienzyme cleaning
agent(3M multienzyme cleaning agent).The
 recommended reagent concentration is (5-10)mL/1L may worsen stains, such as ethanol and alcohol. regulations. 285 and tested in accordance with DIN EN ISO 17665. image not clean surface as per the
distilled water, immersed for (2-10)min at (25-40) °C.  Only cleaning agents and disinfectants permitted for  High-temperature disinfection should be performed Steam Sterlizaiton Parameters steps described in
 Completely immerse the device into cleaning water use with the product should be used. Follow the with fully demineralized water and the A value must Sterilizaiton Temperature Exposure Pressure "Cleaning and
and clean the inside surface of adapter and connect manufacturer's instructions. Follow the reach above 3,000. process time Disinfection".
o
parts of lens and endoscope rod with a short cleaning manufacturer's instructions for recommended  Maintain and inspect the endoscope cleaning and Gravity 121 C 30min 102.9kPa Remove the residues
brush. concentrations, temperature, period of usage. disinfection machine regularly. displacement using the steps
o
 Wipe the surface of device with disposable soft clothes,  Do not use a metal cleaning brush as it may  Put the product in a meshed tray (to ensure all parts Pulsation 132 C 4min 205.8kPa There are deep stains described in
until no visible soil can be observed. damage the product surface and cause corrosion. can be flushed). Vacuum on a glass surface "Cleaning and

2. Intermediate cleaning  Strictly follow the processing parameters Sterilization tolerance cycle: 500 times. Disinfection" and

 Rinse the device with demineralized or distilled water. recommended by the chemical manufacturers, such check water quality.
Sterilization 2. Gas sterilization
 Dry the device external surface with disposable soft as temperature, concentration, exposure time, etc. The lens system is Send back the faulted
Before sterilizing the endoscope, make sure it functions It is recommended to use the following validated ethylene
cloths. Otherwise, the following problems may result: damaged or not endoscope system
normally and goes through the complete cleaning and oxide sterilization parameters:
 Wipe the surface of eye lens, objective lens and light  The optical performance of materials will decline, sealed properly for repair.
disinfection process, please conduct testing as per the EO concentration Temperature Humidity Dwell time
transmitting lens with sterile swab soaked 70%-alcohol such as tarnishing or fading of titanium or Clean the glass
requirements of "Getting Started" chapter ("Testing" section). 100% 54 oC 50%RH 360min
clockwise direction. aluminum surfaces. For aluminum surfaces, the surface as per the
To ensure the ethylene oxide residues at a level that does no The glass surface is
 Rinse the surface of eye lens, objective lens and light chemicals with pH>8 used for processing will steps described in
 Endoscopes marked "AUTOCLAVE" may be given harm to the human body, the sterilized endoscope should go not clean
transmitting lens with demineralized or distilled water. cause surface changes. "Cleaning and
priority for using pressure steam sterilization. through a 12-hour resolution at a well- ventilated room with a
 Dry the device surface with disposable soft clothes.  Material damage, such as corrosion, cracking, Disinfection".
 It is not recommended to use several sterilization temperature no less than 40℃ before reuse.
3. Disinfection fracturing, premature aging, or expansion. Remove the residues
methods because it may cause a significant decline Sterilization tolerance cycle: 500 times.
 Do not use the preparations that could lead to the using the steps
 Only use disinfectants that have been identified to be
of equipment performance. Only use one Note: after long time sterilization, the color of the color ring
synthetic materials splitting, or make the materials There are deep stains described in
effective and compatible with an endoscope. The
recognized method. will fade, which is a normal phenomenon. It will not affect the
brittle. on a glass surface "Cleaning and
recommended sterilization parameters for reference:
 The endoscope may be damaged if it is cooled sealing performance and the whole machine function.
 After manually cleaning/disinfecting, check whether Disinfection" and
-- 2% glutaraldehyde, disinfection time 20-30 min,
quickly after autoclave sterilization, so it should
there are stains remaining on the visible surfaces. If The image check water quality.
solution temperature 20-25°C;
naturally cool to room temperature after autoclave Maintenance
necessary, repeat the cleaning steps. is too dark Problems with light Use the beams with a
-- 0.55% o-Phthalaldehyde, disinfection time 12 min,
sterilization.
 Please use the cleaning, disinfection and The product is maintenance-free and contains no with low beams reliable connection
solution temperature 20-25°C;
 The product is very sensitive to impacts at high
sterilization procedure recommended in this components requiring maintenance by the user and brightness. The light beams are
 Fully immerse the endoscope in the disinfectant to
temperature, so avoid impacting and vibrating the
manual. not connected with Check the connection
ensure all accessible surfaces are moistened; manufacturer.
product at high temperatures.
 Flush the internal cavities and guide slots with a the endoscope of light beams

washing gun at least five times. correctly

Mechanical cleaning
Before sterilization, please place the endoscope in the Repair Check fiber optics as
4. Final cleaning
Fully flush and wipe the endoscope with demineralized water sterilization tray, and then wrap with two polypropylene If you need repair service, please contact the manufacturer per the requirements
 After disinfection, flush the product thoroughly with Defects of fiber optics
after use to remove blood, mucus, and other residues, and sterilization wrap.
or designated repair center. Information about authorized of "Getting Started"
demineralized water three times (including all
then put it in an endoscope cleaning and disinfection Recommended sterilization methods that have been verified:
("Testing" section)
accessible surfaces). Flush each time for at least 2 repair centers may be obtained from the manufacturer. In
Sterilization Type Applicable Model
machine for cleaning and disinfection as per the operating Replace the light
minutes. New water should be used for flushing each order to process your repair request more efficiently, please Faults of light beams
Steam sterilization M 01030A, M 01000A
beams and clear the
time. instructions of the machine. and light sources
Gas sterilization M 01030A, M 01000A, M 01030， provide the following product information:
bulb.
 Clean all unseen surfaces with a washing gun at least For the best results, use an alkaline cleaner with a pH of at M 01000  Product reference (REF)
Clean the glass
five times and leave enough time to let all the water The light exiting or
least 10 for automatic cleaning.  Serial number (SN)
surface as per the
drain out. incoming surface of
1. Steam sterilization  Detailed description of faults
steps described in
5. Drying fiber optics is not
 Only products marked with "autoclave sterilization For the loading method of autoclave sterilization, please refer The "Cleaning and
 Wipe the product with lint free cloth; clean
allowed" may receive high temperature disinfection. to the operating instructions of the corresponding sterilizer.  Choose appropriate and firm packaging (the original lighting is Disinfection".
 Blow dry the parts which cannot be cleaned with lint
 After manually cleaning/disinfecting the product, As the sterilizer and its operating conditions may affect package is preferred). yellow. Check the light
free cloth with medical grade filtered compressed air
check whether there are stains remaining on the sterilization, it is suggested that the sterilization process be Light beams are not beams (such as
(maximum pressure =0.5 bar).
visible surfaces. If necessary, repeat the cleaning reconfirmed and monitored before sterilization in accordance clean or fail illuminating on white

steps. with the international standards (such as ISO 17665), surface).

 Do not put the product in an ultrasonic cleaner for
 Please select an automatic endoscope cleaning and national standards, or hospital sterilization management Troubleshooting Patches Insufficient cleaning Clean again and wipe
cleaning and/or disinfection. rules related to autoclave sterilization. Faults Possible cause Solution and color (such as residual thoroughly if
disinfection machine that is certified to meet local
 Do not use cleaning agents or disinfectants that The sterilizer must be certified in accordance with DIN EN Blurring The glass surface is Clean the glass
fading protein) necessary (mm) Product Standard
3 1
Flushing between certificate configuration

cleaning and Standard

Ensure adequate M 4 Warranty card 1
disinfection or configuration
flushing is made
sterilization each time 01000A/M 80 0 321 Φ10
between each
is not sufficient
treatment. 01000
(especially before
sterilization). M01030A/
80 30 321 Φ10
The chlorine
Check the water M 01030
concentration is too
quality
high

The water or Table of Optical Performance Parameters

sterilization steam
Check the water Item Basic parameters
contains heavy metal
quality, and use
ions and/or silicate Designed optical working distance d0 50 mm
distilled water
and results in the
(deionized water) Central angle resolution of field of view 7.0C/(°)
increased content of
only if necessary
iron ions, copper ions Range of effective depth of field 3～200 mm
and magnesium ions.
Color rendering index Ra under A
Check the water 91
The concentration of standard illuminant
quality, and use
minerals (such as Color rendering index Ra under D65
distilled water 91
calcium) or organic standard illuminant
(deionized water)
matters is too high Synthetical relative effect of edge light
only if necessary 0.18
energy SLe-Z
The disinfectant or Replace the
cleaning agent is disinfectant or
contaminated or used cleaning agent Operating Environment
too frequently regularly 1. Temperature: 10ºC ~+40ºC

The external surface Inspect and maintain 2. Humidity: 5%～95%, non-condensing

is rusty (for example, the system; check the 3. Atmospheric pressure: 70 kPa~106 kPa
damaged instruments compatibility and
or those susceptible damage of materials
to rusting are used to during general
Storage and Transportation
pass through steam treatment and Environment
or for equipment prevent overlapping 1. Temperature: -40ºC ~ +70ºC
preparation) contact. 2. Humidity: 5%～95%, non-condensing
Avoid contact with
3. Atmospheric pressure: 70 kPa~106 kPa
Contact corrosion other corrosive
Put clean and disinfected products in packages capable of
products
isolating the products from bacteria and store them in a dark,

Product Specifications cool, and suitable room.

Basic Parameters and Performance Packing List

No. Name Quantity Remarks
Table of Basic Parameters
Rigid optical Standard
Field Aspect Working Maximum width of 1 1
laparoscope configuration
Model
angle (°) angle (°) length insertion (mm) Operator's Standard
2 1
manual configuration