WORLD OF MEDICINE A127 User manual

A127
Pump for Arthroscopy A127
Instructions for Use en

Manufacturer:
W.O.M. WORLD OF MEDICINE GmbH
Salzufer 8
10587 Berlin, Germany
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
W.O.M. WORLD OF MEDICINE GmbH
Alte Poststraße 11
96337 Ludwigsstadt, Germany
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
CE marking according to Directive 93/42/EEC
Type: A127 / 1201161 / 10000012999 07 Issued: 2020-01
en This instructions for use contains information that is subject
to copyright. All rights reserved. This instructions for use
should not be photocopied, duplicated on microfilm or other-
wise copied or distributed, completely or in part, without the
approval of W.O.M. WORLD OF MEDICINE GmbH.
We reserve the right to technical changes without prior notification due to
the continuous further development of our products. Function or design
may partially differ from the description in the instructions for use. Please
contact us for additional information about this or any of our other
products.
Some of the parts and equipment referred to in this instructions for use
bear registered trademarks but are not identified as such. It should there-
fore not be assumed that the absence of the trademark symbol indicates
that any given designation is not subject to trademark protection.
Users of this product should not hesitate to point out to us any errors or
unclarities in this instructions for use.
Copyright © W.O.M. WORLD OF MEDICINE GmbH

Symbols and Description
Symbols and Description
Follow instructions for use
(white image on a blue back-
ground)
Caution
Consult instructions for use
Authorized for Sale or use by
Physician only
Type BF applied part
Equipotentiality
Degrees of protection
provided by enclosures (IP-
Code)
Protective earth (Ground)
Alternating current
Service
Service
Catalogue number
Batch code
Serial number
Do not reuse
Do not resterilize
Sterilized using ethylene ox-
ide
Non sterile
Date of manufacture (YYYY-
MM-DD)
Manufacturer
Use by date (YYYY-MM-DD)
Quantity
Not made with phthalates
Number of autoclaving
cycles
Keep dry
Top-Bottom
Fragile
Keep away from sunlight
Protect from heat and radio-
active sources
en

Temperature limit
Humidity limitation
Atmospheric pressure limita-
tion
Do not use if package is
damaged
Waste management
Transport conditions
Storage conditions
Recyclable packaging
(Greendot symbol)
Recycling PAP PE
RFID tag, general
Non-ionizing electomagnetic
radiation
Symbols and Description
en

v
Table of Contents
1 Important User Notes ...............................................................................................................................................................................................7
2 Safety Information..................................................................................................................................................................................................... 8
3 General Information..................................................................................................................................................................................................9
3.1 Description of the Device........................................................................................................................................................................ 9
3.2 Intended Use and Contraindications................................................................................................................................................... 9
3.2.1 Intended Use............................................................................................................................................................................................... 9
3.2.2 Contraindications....................................................................................................................................................................................10
3.3 General Warnings and Precautions ...................................................................................................................................................10
3.3.1 General Warnings ...................................................................................................................................................................................10
3.3.2 Precautions................................................................................................................................................................................................13
3.4 Device-Specific Warnings: Arthroscopy Indication .......................................................................................................................15
4 Device Setup...............................................................................................................................................................................................................17
4.1 Scope of Delivery .....................................................................................................................................................................................17
4.2 Setting up and Connecting the Device..............................................................................................................................................17
4.3 Mounting the Pump ...............................................................................................................................................................................20
4.3.1 Mounting on Stand.................................................................................................................................................................................20
4.3.2 Positioning in Device Rack ....................................................................................................................................................................21
5 Operating the Device...............................................................................................................................................................................................22
5.1 Front of the Device..................................................................................................................................................................................22
5.2 Device Side ................................................................................................................................................................................................22
5.3 Rear of the Device ...................................................................................................................................................................................22
5.4 Turning the Device On ...........................................................................................................................................................................23
5.5 Irrigation Tube Sets Overview .............................................................................................................................................................23
5.6 Using the Irrigation Tube Sets.............................................................................................................................................................24
5.7 Inserting the Irrigation Tube Sets.......................................................................................................................................................25
5.8 Connecting the Irrigation Fluid Bags.................................................................................................................................................28
5.9 Setting Nominal Values.........................................................................................................................................................................29
5.10 Starting the Device .................................................................................................................................................................................29
5.11 Using the WASH Function ....................................................................................................................................................................30
5.12 Switching the Device Off.......................................................................................................................................................................30
6 Safety Functions........................................................................................................................................................................................................32
6.1 Device Self-Test........................................................................................................................................................................................32
6.2 Exceeding Nominal Pressure................................................................................................................................................................32
7 Function Test .............................................................................................................................................................................................................33
7.1 Preparing the Function Test.................................................................................................................................................................33
7.2 Performing the Function Test..............................................................................................................................................................33
7.3 Checking the WASH Function.............................................................................................................................................................. 34
7.4 Ending the Function Test ......................................................................................................................................................................34
8 Using the Device during Surgery .........................................................................................................................................................................35
9 Care and Maintenance............................................................................................................................................................................................37
9.1 Maintenance Intervals...........................................................................................................................................................................37
9.2 Cleaning the Device................................................................................................................................................................................37
9.3 Maintenance by Authorized Service Technician ............................................................................................................................37
9.4 Replacing the Fuse ..................................................................................................................................................................................38
9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA)................................................................................................................39
9.5.1 General Notes...........................................................................................................................................................................................39
9.5.2 Reprocessing.............................................................................................................................................................................................40
10 Annual Inspection.....................................................................................................................................................................................................46
10.1 Electrical Safety Test...............................................................................................................................................................................46
10.2 Basic Function Test .................................................................................................................................................................................46
10.3 Pressure Measuring Test.......................................................................................................................................................................47
11 Accessory List.............................................................................................................................................................................................................48
12 Electromagnetic Compatibility.............................................................................................................................................................................49
12.1 Electrical Connections............................................................................................................................................................................49
12.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ..............................................................................49
12.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity .....................................................50
en

vi
13 Technical Data...........................................................................................................................................................................................................52
14 Error and Warning Messages................................................................................................................................................................................54
15 Appendix.....................................................................................................................................................................................................................56
15.1 Test log .......................................................................................................................................................................................................56
Glossary.......................................................................................................................................................................................................................58
Index.............................................................................................................................................................................................................................60
en

Important User Notes
7 / 62
1 Important User Notes
Read the manual carefully and become familiar with the operation and function of
the device and the accessories before use during surgical procedures. Non-observ-
ance of the instructions listed in this manual can lead
• to life-threatening injuries of the patient,
• to severe injuries of the surgical team, nursing or service personnel, or
• damages or malfunction of device and/or accessories.
Subject to technical changes
The manufacturer reserves the right to modify the appearance, graphics, and tech-
nical data of the product through continued development of its products.
Please note
Paragraphs marked with the words WARNING, CAUTION, and NOTE carry special
meanings. Sections marked with these words must be given special attention.
WARNING!
The safety and/or health of the patient, user, or a third party are at risk. Comply
with this warning to avoid injury to the patient, user, or third party.
CAUTION!
These paragraphs include information provided to the operator concerning the in-
tended and proper use of the device or accessories.
NOTE!
These paragraphs contain information to clarify the instructions or provide addi-
tional useful information.
en

Safety Information
8 / 62
2 Safety Information
Federal Law (only for U.S. market) CAUTION!Federal law restricts this device to sale by or on the order of a physician.
Exclusion of liability The manufacturer is not liable for direct or consequential damages, and the war-
ranty becomes null and void if:
• the device and/or the accessories are improperly used, transported, stored,
prepared, or maintained;
• the instructions and rules in the instructions for use are not adhered to;
• unauthorized persons perform repairs, adjustments, or alterations on the
device or accessories;
• unauthorized persons open the device;
• the prescribed inspection and maintenance schedules are not adhered to.
The handing over of technical documents does not constitute authorization to
make repairs or alterations to the device or accessories.
WARNING! Modification of the devices A127 is not permitted.
Authorized service technician Only an authorized service technician may perform repairs, adjustments, or altera-
tions on the device or accessories and use the service menu. Any violation will void
the manufacturer's warranty. Authorized service technicians are only trained and
certified by the manufacturer.
Care and maintenance The service and maintenance of the device and its accessories has to be carried out
as per instructions to ensure the safe operation of the device. For the protection of
the patient and the operating team, check that the device is complete and func-
tional before each use. Maintenance of the device may not be performed during
the operation.
NOTE!Service or maintenance work may not be carried out during surgery.
Contamination Before shipping, decontaminate device and accessories in order to protect the ser-
vice personnel. Follow the instructions listed in these instructions for use. If this is
not possible,
• the product must be clearly marked with a contamination warning and
• is to be double-sealed in safety foil.
The manufacturer has the right to reject contaminated products for repair.
Waste management This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately. For
disposal of the device and its accessories, please consult the manufacturer or an
authorized disposal company, in compliance with legal or national regulations.
en

General Information
9 / 62
3 General Information
3.1 Description of the Device
The device itself is non-invasive and designed for use in non-sterile areas. It pumps
medically sterile irrigation fluids through a sterile tube. These fluids are used to dis-
tend and irrigate corresponding body cavities to provide space and improve visibil-
ity for the attending physician. The device can be used with electrolyte-free media
(e.g., glycine 1.5% or sorbitol 3.0%) and with isotonic, electrolyte-containing me-
dia (e.g., saline 0.9 % or Ringer's lactate). The device functions only with the tube
sets described in the accessory list (see Chapter Accessory List [}48]).
During arthroscopic procedures the device can be operated at nominal flow rates
of up to 1.5l/min and a maximum pressure of 150mmHg can be selected.
The device operates with a completely non-contact pressure measurement of the
irrigation medium. The contact-free pressure measurement is achieved by integrat-
ing the pressure membrane into the tube set. The pressure membrane transfers
the tube pressure to the electronics of the device via a pressure sensor. The pres-
sure control circuit continuously compares the actual pressure with the nominal
pressure. The function of the device is to maintain the nominal pressure.
3.2 Intended Use and Contraindications
3.2.1 Intended Use
WARNING!
Use only with necessary training
The device is intended to be used only by surgeons and support personnel with the
necessary training in arthroscopic procedures.
The product A127 is an irrigation pump for diagnostic and/or surgical arthroscopic
procedures. Such procedures may include:
• Ligament injuries
• Meniscus injures
• Cartilage injures
• Operating planning and re-examination
The irrigation pump serves to distend and irrigate joints in the knee, shoulder, hip
and elbow, as well the wrist and ankle joint.
The user can select the desired joint pressure.
The pump attempts to reach and maintain the preset pressure in the joint by sup-
plying irrigation fluid. If the joint cannot be drained (e.g., because closed valve at
instrument), and if the pre-selected pressure has been reached, the pump reduces
the inflow of the fluid and attempts to maintain the preset pressure. If the intraar-
ticular pressure falls below the selected value, fluid automatically continues to be
supplied.
The device is used in the non-sterile area of a lit or darkened operating room and
can be attached with a toggle bolt to the rear side of the device on a tripod, or can
be set up in an equipment rack as well. The positioning should be at the height of
the joint to be irrigate.
Patient population
There are no restrictions to consider specifically concerning the patient population.
Recommended pressure
The nominal pressure can be preset to between 5 and 150mmHg. The preset pres-
sure should be based on the average blood pressure of the patient to prevent
bleeding in the joint. The manufacturer recommends the following pressure set-
tings for the following application areas:
Knee joint 50mmHg
Shoulder joint 50mmHg
Hip joint 60mmHg
Elbow joint 30mmHg
Ankle joint 70mmHg
en

General Information
10 / 62
Wrist joint 30mmHg
Each surgery and each patient require different parameters. The values indicated
by manufacturer are therefore only recommendations and are not intended to sub-
stitute or replace the expertise of the surgeon.
The maximum flow is limited to 1.5l/min on the device side and is automatically
reduced by the pump once the nominal pressure has been reached.
Clinical use When performing monopolar electrosurgery, only non-conductive irrigation fluids
may be used. Examples include glycine, sorbitol, mannitol, sorbitol plus mannitol,
and dextran.
3.2.2 Contraindications
Use of this device to inject fluid into a joint is prohibited whenever arthroscopy is
contraindicated. Refer to your endoscope’s manual for absolute and relative con-
traindications.
Arthroscopy is contraindicated in the following cases:
• Ankylosis
• Inflammation or bacterial contamination
The device may not be used to inject medication.
The device is not designed or intended for use with gas.
3.3 General Warnings and Precautions
3.3.1 General Warnings
WARNING!
Risk of electrical shock
To prevent electrical shock, do not open this device. Never open this device your-
self. Notify the authorized service technicians of any required repairs.
WARNING!
Risk of electrical shock
To avoid the risk of electrical shock, only use this device when connected to a prop-
erly grounded power supply network.
WARNING!
Maintenance and calibration
Do not open the device. The device may not be opened or calibrated by the user.
Only authorized service technicians are permitted to repair, calibrate, or modify the
device or its equipment.
WARNING!
Power supply
Disconnection from the power supply is only guaranteed if the mains plug is pulled
from the mains wall socket.
WARNING!
Technique and procedures
Only the physician can evaluate the clinical factors involved with each patient and
determine if the use of this device is indicated. The physician must determine the
specific technique and procedure that will accomplish the desired clinical effect.
en

General Information
11 / 62
WARNING!
Check all factory settings
Factory settings are not mandatory settings for the physician. The physician is re-
sponsible for all settings affecting the surgical procedure.
WARNING!
Original accessories
For your own safety and that of your patient, use only original accessories.
WARNING!
Acoustic signals
Different default settings of the warning message for identical or similar devices in
the operating room may cause a risk due to conflicting acoustic signals.
WARNING!
Checking the warning signals
The warning signals must be checking prior to each device use. The system is to be
set up so that all warning signals can be perceived.
WARNING!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environments.
WARNING!
Professional qualification
The instructions for use do not include descriptions or instructions for surgical pro-
cedures/techniques. It is not suitable for training physicians in the use of surgical
techniques. Medical peripherals and devices may be used only by physicians or
medical assistants with the appropriate technical/medical qualifications working
under the direction and supervision of a physician.
WARNING!
Functional test
The functional test must be performed by the user prior to each surgery.
WARNING!
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and
sterile accessories if so indicated.
WARNING!
Replacement device and accessories
In case the device or any of the accessories fail during surgery, a replacement
device and replacement accessories should be kept within close proximity to be
able to finish the operation with the replacement components.
en

General Information
12 / 62
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected. Make
sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.
WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
WARNING!
Replace the fuse
Replace the fuse only with a fuse of the same type and rating (see ChapterTech-
nical Data [}52]).
WARNING!
Touching patient and device
The operating team must not touch both patient and device while the patient is in
sterile area and device is in non sterile area of the operating theatre.
WARNING!
Touching patient and device
Do not touch patient and the Standby/ON key at the same time.
WARNING!
ME System (Medical Electrical System)
Use only parts and/or devices from ME systems (see ChapterGlossary) in patient
environments in compliance with the standard IEC60601-1 in the respective cur-
rently valid version.
WARNING!
ME System (Medical Electrical System)
Connect only items that have been specified as part of the ME system or specified
as being compatible with ME system.
WARNING!
Additional equipment
Additional equipment connected to medical electrical devices must be demon-
strated to be compliant with their respective IEC or ISO standards (IEC 60601-1,
IEC60950 or IEC62368 for data processing equipment). Furthermore, all configura-
tions must comply with the normative requirements for medical systems (see sec-
tion 16 of the last valid edition of IEC60601-1). Anyone who connects additional
devices to medical electrical equipment is a system configurator and as such is re-
sponsible for the system's compliance with the normative requirements for sys-
tems. Please contact the technical service if you have additional questions.
en

General Information
13 / 62
WARNING!
Obvious defects
Never use the device if it has suspected or confirmed defects, especially if these in-
volve the power plugs or the mains power supply connection cables. In this case
have the device repaired by authorized service personnel.
WARNING!
Instrument replacement
Stop the device using the START/STOP key if replacing the instrument during sur-
gery.
WARNING!
Preventing infections
Sterilize reusable instruments and reusable tubes sets (NOT FOR SALE IN USA) be-
fore surgery to prevent infections. Check all the single-use/disposable items before
removing them from the package to ensure that the packaging is intact and that
the expiration date is still valid.
WARNING!
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product functionality
due to reuse. Risk of injury, illness or death due to contamination and/or impaired
functionality of the product! Do not reprocess the product.
WARNING!
Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.
3.3.2 Precautions
CAUTION!
Incorrect voltage
Check to make sure the available mains voltage matches the data listed on the type
label attached to the back of the device. Incorrect voltage can cause errors and mal-
functions and may destroy the device.
CAUTION!
ME systems
The medical electrical (ME) device is suitable for integration in ME equipment sys-
tems (see Chapter Glossary). Operation of the ME device in vicinity of non-ME
devices may result in voiding the intended use of the ME device.
CAUTION!
ME Device in Rack
The ME device may not be used when stacked or stored directly adjacent to or with
other devices. If it should be necessary to operate the device close to stacked with
other devices, the ME device or ME system should be monitored to ensure it works
properly as configured.
en

General Information
14 / 62
CAUTION!
Endoscope
The device may only be connected with endoscopes designed for and featuring the
technical specification permitting such a combined use. Any utilized endoscopes
must comply with the most recent versions of EC60601-2-18 and ISO8600. Com-
bining/connecting with other devices generates a medical electrical system (MES).
The system configurator is responsible for compliance with the standard
IEC60601-1 / EN60601-1 in its latest version.
CAUTION!
Peripheral Devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications in the respective cur-
rent valid version: IEC 60601-2-18 / EN 60601-2-18 for endoscopic devices and
IEC60601-1 / EN60601-1 for electrical medical devices. All configurations have to
comply with IEC60601-1 / EN60601-1 specifications. Whoever connects additional
equipment to signal output or signal input is considered the system configurator
and as such is responsible for complying with requirements of the standard
IEC60601-1 / EN60601-1.
CAUTION!
Electrical interference
(See ChapterElectromagnetic Compatibility [}49]). Care was taken during the de-
velopment and testing of this device that electrical interference of or from other
devices or instruments was practically eliminated. However, if you still detect or
suspect such interference, please follow these suggestions:
• Move this, the other, or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert
CAUTION!
Use of other accessories, other transducers and cables
The device may only be connected with endoscopes designed for and featuring the
technical specification permitting such a combined use. Any utilized endoscope
must comply with the most recent versions of IEC60601-2-18 and ISO8600. Com-
bining/connecting with other devices generates a medical electrical system (MES).
The system configurator is responsible for compliance with the standard
IEC60601-1 / EN 60601-1 in its last version. The use of accessories, transducers,
and cables other than those specified, with the exception of transducers and cables
sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM (see
ChapterGlossary) as replacement parts for internal components, may result in in-
creased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
CAUTION!
Not to be used with a defibrillator
The device may not be used in conjunction with a defibrillator since it is not
equipped with corresponding safety elements. The manufacturer accepts no liabil-
ity in this case for ensuing damage.
CAUTION!
Indoor climate
Before switching on the device, sufficient time must have passed to adjust to the
indoor climate.
en

General Information
15 / 62
CAUTION!
Ventilation of the device
• Avoid device overheating.
• Ensure free air circulation especially to the bottom and rear of the device (rear
panel distance of at least 10cm).
CAUTION!
Patient group
There are no restrictions as to the specification of the patient group when using
the device as intended and its use does not endanger the patient's health.
CAUTION!
Cleaning the Device
Do not sterilize the device.
CAUTION!
Overheating
To avoid overheating,
• the device must not be operated for more than 10 minutes at maximum
speed.
• the device must not be operated without fluid in the tube system.
CAUTION!
Mains Power Cable
Any power cables employed by the user that are not provided by the manufacturer
must meet the safety requirements of the national standards in the respective cur-
rent valid version.
CAUTION!
Device setup
Device should be positioned outside of the sterile area in such a way that
• it can be easily disconnected,
• it is easy to use and switch off and on,
• it allows an easy monitoring of the display values, device functions, and access
to the control elements.
3.4 Device-Specific Warnings: Arthroscopy Indication
WARNING!
Irrigation fluid bags
The device is only intended for use with flexible fluid bags. Do not use glass con-
tainers as they might break. With rigid containers, fluid cannot flow quickly
enough due to the vacuum being generated inside of the containers. Risk of implo-
sion with rigid containers.
en

General Information
16 / 62
WARNING!
Pressure settings
The nominal pressure of the described device can be preset to values described in
these Instructions for Use. Select the optimum pressure based on the patient pro-
file, including but not limited to blood pressure, height, weight and age. The manu-
facturer recommends pressure settings for different areas of application; however
these are suggestions only and are not intended to substitute or replace the ex-
pertise of the surgeon.
WARNING!
In case of an overpressure
In case of an overpressure situation, the here described device is equipped with
safety measures to assist in reducing the overpressure. The pump may display
warning signs and start turning the inflow spindle backwards, in an attempt to de-
crease the intra-articular pressure by removing fluid from the joint. Please refer to
the descriptions of various warnings described in these Instructions for Use.
WARNING!
Loss of distension
Distension may be lost when resetting the nominal flow or nominal pressure set-
tings.
WARNING!
Fluid extravasation
Fluid irrigation pumps used in Arthroscopy may cause fluid extravasation into the
surrounding tissue. In severe cases, the resulting pulmonary edema may result in a
serious adverse patient event which may include compartment syndrome, neuro-
praxia, tachycardia, pneumothorax, tissue tearing or nerve compromise. Should ex-
travasation be observed, it is recommended to reduce pressure settings and closely
observe the excess fluid build up.
WARNING!
Height difference
The height difference between the device and the patient must be adjusted cor-
rectly in order to ensure exact pressure measurement.
WARNING!
Keep fluid bags ready for use
Always keep a full fluid bag on hand to replace an empty one. This avoid having to
interrupt surgery due to a lack of distention fluid.
en

Device Setup
17 / 62
4 Device Setup
Setting up
The operation of the device is reserved for medical staff with the relevant profes-
sional qualifications trained to use the device.
4.1 Scope of Delivery
• Device A127
• Instructions for Use
• Power cable
Delivery inspection
WARNING!
Check for defects
Check the product and the packaging for defects prior to use. Do not use if package
is damaged.
CAUTION!
Premature unpacking
Do not premature unpack the devices, until sufficient time must have passed to ad-
apt to the room climate
Always check all parts and accessories of the device immediately after receiving the
shipment. The manufacturer considers only replacement claims that have been im-
mediately submitted or reported to a sales representative or an authorized service
company.
WARNING!
Preventing infections
Sterilize reusable instruments and reusable tubes sets (NOT FOR SALE IN USA) be-
fore surgery to prevent infections. Check all the single-use/disposable items before
removing them from the package to ensure that the packaging is intact and that
the expiration date is still valid.
Returning the device
If it becomes necessary to return the device, always use the original packaging. The
manufacturer does not take responsibility for damage that has occurred during
transportation if the damage was caused by inadequate transport packaging.
Please fill out the return form enclosed at the end of these Instructions for Use. En-
close the Instructions for Use with the device.
Please make sure that all required information has been supplied:
• Name of owner
• Address of owner
• Device type and model
• Serial number (see identification plate)
• Description of defect
4.2 Setting up and Connecting the Device
NOTE!
Locations
The device may be used only in the hospital or operating rooms.
After unpacking, place the device A127 on a flat surface free of vibration located in
a dry environment. The ambient temperature and humidity must meet the require-
ments mentioned in Chapter Technical Data [}52].
en

Device Setup
18 / 62
WARNING!
Falls and crashes
Place the device on a stable and level surface. Cables must be laid safely. Tubes
between the device and the patient must not create any obstruction.
WARNING!
Condensation / Water penetration
Protect device from moisture. Do not use if moisture has penetrated the device.
WARNING!
Not explosion-proof
The device is not explosion-proof. Do not operate the device in the vicinity of ex-
plosive anesthetic gases and not in the vicinity of oxygen-enriched environments.
WARNING!
Functional test
The functional test must be performed by the user prior to each surgery.
WARNING!
Original accessories
For your own safety and that of your patient, use only original accessories.
WARNING!
ME System (Medical Electrical System)
Use only parts and/or devices from ME systems (see ChapterGlossary) in patient
environments in compliance with the standard IEC60601-1 in the respective cur-
rently valid version.
CAUTION!
ME systems
The medical electrical (ME) device is suitable for integration in ME equipment sys-
tems (see Chapter Glossary). Operation of the ME device in vicinity of non-ME
devices may result in voiding the intended use of the ME device.
CAUTION!
ME Device in Rack
The ME device may not be used when stacked or stored directly adjacent to or with
other devices. If it should be necessary to operate the device close to stacked with
other devices, the ME device or ME system should be monitored to ensure it works
properly as configured.
CAUTION!
Switching on the device
Before switching on the device, sufficient time must have passed to adapt to the
room climate.
en

Device Setup
19 / 62
CAUTION!
Ventilation of the device
• Avoid device overheating.
• Ensure free air circulation especially to the bottom and rear of the device (rear
panel distance of at least 10cm).
CAUTION!
Device setup
Device should be positioned outside of the sterile area in such a way that
• it can be easily disconnected,
• it is easy to use and switch off and on,
• it allows an easy monitoring of the display values, device functions, and access
to the control elements.
CAUTION!
Position of the user
To avoid a malfunction, the user must be positioned correctly
• within a display viewing angle of ±50° to operate the device,
• up to 2 m/6.5 ft from the device front for monitoring the actual values.
CAUTION!
To avoid malfunctions
The device A127 should not be used directly next to other devices as this could res-
ult in malfunctions. The device A127 was tested for compliance with IEC60601-1-2
as a stand alone system. Therefore, do not stack other devices on the system or the
pump. If usage in the manner described above is nevertheless required, this system
and the other devices should be monitored to make sure they function properly.
Mains connection
WARNING!
Cable pulling
Always grasp the plug of the power cable when unplugging; never pull on the cable
itself.
CAUTION!
Connection to mains
Do not connect this device or system to a multiple socket-outlet or an extension
cord.
en

Device Setup
20 / 62
CAUTION!
Mains connection
• Make sure the available mains voltage matches the data listed on the type la-
bel attached to the back of the device. Incorrect voltage can cause errors and
malfunctions and may destroy the device.
• Make sure the connection data and technical specifications of the power sup-
ply comply with DIN VDE or national requirements. The mains connection
cable may be plugged only into a properly installed, grounded safety wall
socket (shockproof socket) (see DIN VDE 0100-710).
• Read the device label located in rear of device (type plate) to determine the op-
erating voltage of the device.
Grounding contact The power connection must be equipped with a grounding contact. Use the ori-
ginal power cable to establish a connection between the mains wall socket and the
non-heating device plug located in the rear of the device.
The grounded, shockproof safety wall socket should be near the device and within
easy reach. Disconnect the device from the mains power supply (pull cable out off
the grounded safety wall socket) if the device is not being used for several days or
an extended period. The device is ready for use as soon as all connections are es-
tablished and all cables have been plugged in.
Only for U.S. operators Only use a certified (UL-listed), removable mains connection cable, type SJT, min-
imal 18 AWG, 3 leads. The plug connectors must comply with NEMA 5-15 and
IEC60320-C13. Grounding will only be reliable if the equipment is connected to a
corresponding hospital grade socket.
Potential equalization The equipotential bonding is used as a protective measure against the failure of
the protective conductor according to requirements of IEC60601-1 in the respect-
ively valid version. The installation must be according to the relevant local safety
regulations.
4.3 Mounting the Pump
The device is designed to be suspended from a portable stand or upright placement
in a device rack. Installation and initial startup of the device are to be carried out by
a correspondingly trained service technician authorized by the manufacturer. The
device is installed horizontally with the upper side of the device pointing up. The
height of the installation position of the device above the floor should correspond
with height of the joint.
4.3.1 Mounting on Stand
CAUTION!
Read instructions
Please read the instruction manual for the stand before mounting the pump on the
stand.
CAUTION!
Stability
The position of the device on the stand can affect the stand's stability. If the device
is mounted too high on the stand, the stand may tilt or topple. The user/operator
of the device is responsible for making sure the device cannot be tipped over or
otherwise become unstable.
en