SUNRAY SRF618B6 User manual

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Manufacturer’s Statement
This manual should be used as a reference for operating this instrument only. This company will not
undertake any consequence and responsibility produced by using this manual for other purposes.
This manual contains proprietary information, which is copyright protected and all rights reserved. Any
part of this manual shall not be copied, duplicated or translated into other languages without prior written
approval by our company.
The information contained in this manual is subject to change without notice.
As a result of technical update or user’s special requirement, some parts or components may be somewhat
different from the standard configuration specified in this manual as long as the performance indexes of the
instrument are not affected. Please keep this in mind.
Caution: Federal law restricts this device sale by or on the order of a physician
Manufacturer
Sunray Medical Apparatus Co., Ltd.
Head Office: 4/F No.242 Tianhe Dong Road, Guangzhou,
People’s Republic of China
Postal code: 510620
Tel: [phone]
Fax: [phone]
Website: www.sunra
y
-cn.com
EU REPRESENTATIVE:
Shanghai International Holding Corp. GmbH(Europe)
ADDRESS: Eiffestrasse 80, 20537 Hamburg Germany
Tel: [phone] Fax: [phone]
E-mail: [e-mail]
Copyright © Guangzhou Sunray Medical Apparatus Co., Ltd
Version number: US1.0
Date: Nov. 2015
0123

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Commitment
Our company guarantees that this instrument will not have any quality problem in material and technology
within the guarantee period promised by our company. If the product purchased by the user has such a kind
of quality problem, please notice our company. Our company will provide warranty for the user free of
charge, and will repair or replace the product that is proved to be defective according to actual
circumstances. Please see the “Stipulations for Warranty” specified on the “Warranty Card” for details.
The warranty is void in cases of:
a) damage caused by mishandling during shipping;
b) subsequent damage caused by improper use or maintenance;
c) damage caused by alteration or repair by anyone not authorized by Sunray;
d) damage caused by accidents;
e) replacement or removal of serial number label and manufacture label;
If a product covered by this warranty is determined to be defective because of defective materials,
components, or workmanship, and the warranty claim is made within the warranty period, Sunray will, at
its discretion, repair or replace the defective part(s) free of charge. Sunray will not provide a substitute
product for use when the defective product is being repaired.
The designed service life of this product is 5 years. This company will provide repair service for the user
within the term of the service life.
Note: Consumables such as recorder paper, ultrasonic coupling agent, and recorder cartridge etc. are
out of the scope of warranty.
Caution: Federal law restricts this device sale by or on the order of a physician
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate
data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

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Table of Contents
Manufacturer’s Statement...........................................................................................................................2
Chapter 1Safety guidance ..........................................................................................................................1
1.1Indications for Use .....................................................................................................................1
1.2Contraindication .........................................................................................................................1
1.3Patient Populations.....................................................................................................................1
1.4Warning ......................................................................................................................................1
1.5Safety Notes ...............................................................................................................................3
1.6Definition and Symbols..............................................................................................................4
Chapter 2Overview of the Instrument........................................................................................................6
2.1Expected Functions and Purposes ..............................................................................................6
2.2Configurations............................................................................................................................6
2.3Overview ....................................................................................................................................6
2.4Accessories.................................................................................................................................9
2.5Screen .......................................................................................................................................10
2.6Ordering Information ...............................................................................................................12
Chapter 3Installation Guide .....................................................................................................................14
3.1Unpacking and checking ..........................................................................................................14
3.2Installing Battery ......................................................................................................................14
3.3Installation................................................................................................................................15
3.4Connecting Power Cable..........................................................................................................15
Chapter 4Alarm........................................................................................................................................16
4.1Alarm classification..................................................................................................................16
4.2Audible Alarm ..........................................................................................................................16
4.3Visual Alarm.............................................................................................................................17
4.4Reviewing Alarms ....................................................................................................................17
4.5Alarm Treatment Measures ......................................................................................................18
4.6Testing Alarms..........................................................................................................................19
4.7Physiological Alarm Defaults...................................................................................................19
4.8Alarm information....................................................................................................................20
Chapter 5Printing .....................................................................................................................................21
5.1Function Description ................................................................................................................21
5.2Loading Recorder paper ...........................................................................................................21
5.3Choosing Paper Speed..............................................................................................................22
5.4Print Self-Check .......................................................................................................................22
5.5Select the printing range...........................................................................................................22
5.6Print the traces..........................................................................................................................23
5.7Understanding Recorder Paper Printout...................................................................................24
5.8Tearing Off the Paper ...............................................................................................................25
Chapter 6Settings.....................................................................................................................................26

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Chapter 7Pre-monitoring Preparation ......................................................................................................32
7.1Switching On............................................................................................................................32
7.2Adjusting Screen Angle............................................................................................................32
7.3Setting Date and Time ..............................................................................................................32
7.4Connecting Transducers ...........................................................................................................32
7.5Placing Transducers in the Holder............................................................................................33
Chapter 8Fetal Monitoring.......................................................................................................................35
8.1Confirming Fetal Life...............................................................................................................35
8.2Monitoring FHR with Ultrasound ............................................................................................35
8.3Monitoring Twin FHRs ............................................................................................................37
8.4Monitoring Triple FHRs...........................................................................................................37
8.5Monitoring Uterine Activity Externally ...................................................................................38
8.6Monitoring Fetal Movement ....................................................................................................39
8.7Start Monitoring .......................................................................................................................40
8.8Inputting Maternal Information................................................................................................40
8.9Reviewing.................................................................................................................................41
8.10Delete Files...............................................................................................................................42
8.11Fetal Monitoring Display .........................................................................................................43
Chapter 9After Monitoring ......................................................................................................................47
Chapter 10Maintenance and Cleaning ...............................................................................................48
10.3Cleaning and Disinfecting of Reusable Belts...........................................................................50
10.4Cleaning of Recorder................................................................................................................51
10.5Sterilizing .................................................................................................................................51
Chapter 11Product Specifications......................................................................................................52
Chapter 12Abbreviation.....................................................................................................................55
Chapter 13EMC Information .............................................................................................................56
Chapter 14Ultrasonic Related Information ........................................................................................60
Chapter 15Troubleshooting................................................................................................................66

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Chapter 1 Safety guidance
NOTE:
1. In order to ensure the operator and patient’s safety, read through this chapter before using this monitor.
2. This user manual is written to cover the maximum configuration. Therefore, your model may not have
some of the parameters and functions described, depending on what you have ordered.
1.1Indications for Use
The SRF618B6 Fetal Monitor is intended for non-invasive monitoring of the Fetal Heart Rate (FHRs),
Uterine Activity (UA), and Fetal Movement (FM). It also provides the fetal heart beat sound with
internal speaker.
It is intended for antepartum use by trained healthcare personnel. It is not intended for home use.
1.2Contraindication
The Sunray Fetal Monitor is NOT intended for:
use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).
1.3Patient Populations
Pregnant women
1.4Warning
This monitor cannot be used for monitoring neonate.
To avoid the risk of electric shock, this equipment must only be connected with the supply mains
with protective earth. For this purpose, this instrument is equipped with a three-wire power cord.
When this cord is plugged into a suitable three-wire socket, the casing of this instrument is
connected to the earth wire. The operator shall check whether this instrument is properly earthed
before using this instrument every time. Whenever there is a possibility that the protective earth is
damaged, the use of this instrument shall be stopped, and measures shall be taken to avoid this
instrument being operated by someone accidentally. If GND is not available, this socket shall not
be used, but rechargeable battery can be used to supply power for monitor.
No unauthorized modification of this monitor is allowed.
The monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all
transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI,
otherwise harm to the patient or the user can result.
You must check that the equipment, cables and transducers do not have visible evidence of damage
that may affect patient safety or monitoring capability before use. If damage is evident,

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replacement is recommended before use.
Make sure that the power is turned off and the power cord is disconnected from the AC socket
before connecting or disconnecting equipment. Otherwise, the patient or operator may receive
electrical shock or other injury.
Check everyday if the skin is irritated from attachment of cardiograph electrodes, if so, change for
new electrodes or change their sites every 24 hours.
Do not subject the transducer to autoclaving.
The lower limit and the upper limit of parameter must be set based on clinical practices and general
clinical experiences.
Before cleaning the monitor or the transducers, make sure that the equipment is switched off and
disconnected with the power line.
Do not use EtO gas or formaldehyde to disinfect the monitor.
According to the requirements for application environmental safety, this instrument cannot be used
at a place where an inflammable anesthetic or gas mixture exists.
If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the
limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.
Please pay attention to the ultrasonic energy radiation and reduce the time of ultrasonic radiation
during the diagnoses
Do not apply this monitor simultaneously with other PATIENT-connected equipment, such as, a
cardiac pacemaker or other electrical stimulators, on the same patient.
SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make
certain that your hands are clean and dry before touching a power cord.
Accessory equipment connected to the analog and digital interfaces must be certified according to
the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN
60601-1 for medical equipment). Furthermore all configurations shall comply with the valid
version of the system standard IEC/EN 60601-1-1. Anybody who connects additional equipment to
the signal input connector or signal output connector to configure a medical system must ensure
that the system complies with the requirements of the valid version of the system standard IEC/EN
60601-1-1. If in doubt, consult our technical service department or your local distributor.
The disposable accessories are intended to be used only once. Dispose of them properly after use
and do not reuse them.
Clinical decision making based on the output of the device is left to the discretion of the provider.
For Using The Battery:
Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the
user manual and safety precautions thoroughly.
Unplug the monitor before installing and removing the battery.
Do not short-circuit the battery by connecting the battery cable connector or battery socket with
metal objects or solder.
Do not connect the battery directly to an electric outlet or cigarette lighter charger.
Do not heat or throw the battery into a fire.
Do not use or leave battery close to fire or other places where temperatures may be above +60 ºC
(+140 ºF).
Do not immerse, throw or wet the battery in water/ seawater.
Do not destroy the battery: Do not pierce battery with a sharp object such as a needle; Do not hit

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with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the
battery.
1.5Safety Notes
This instrument is a conventionally sealed device, which cannot prevent water from intruding.
All the transducers, buttons and their connecting cables shall not be soaked in water or other liquid
materials, and shall be cleaned, sterilized and operated according to the methods specified in this
manual.
This instrument is a continuously working device.
Do not posit the instrument to make it difficult to operate the power plug which uses to isolate the
instrument circuits electrically form the supply mains.
The AC input at the back panel of the instrument can be connected with the 100V~240V AC Power
by electrical wires supplied with this instrument.
It shall be ensured that there is no condensed water with the instrument when it is being operated.
The cable connecting the patient to the instrument shall not contact with other electrical equipment,
and it shall be ensured that there is no electrolyte on it.
Please place the monitor on level and stable supporting plane, not on the places that can easily
shock or wake. Enough space should be left around the monitor so as to guarantee normal
ventilation.
A dedicated medical ultrasound jelly shall be used for the FHR transducer under normal operation,
and cannot be replaced by water or other liquids.
The uterine contraction pressure transducer shall not be coated with any ultrasound jelly or other
liquid materials under normal operation, and shall be prevented from moisture at any other time.
The monitor does not contain any parts for self-repair by users. The repair of the instrument must
be conducted by the technical personnel authorized by the manufacturer.
The recorder paper should be stored in a cool, shady and dry environment.
When an alarm occurs, you should always check the patient’s condition firstly.
Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area,
high-temperature and humid environment.
When installing the unit into a cabinet, allow for adequate ventilation, accessibility for servicing,
and room for adequate visualization and operation.
Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the
equipment immediately after moving it from a cold environment to a warm, humid location.
Switch off the system power before cleaning. Cleaning consists of removing all dust from the
exterior surface of the equipment with a soft brush or cloth.
Electromagnetic Interference - Ensure that the environment in which the monitor is installed is
not subject to any source of strong electromagnetic interference, such as CT, radio transmitters,
mobile phone base stations, etc.
Do not use mobile phones nearby in the process of monitoring.
If the terminals of the battery become dirty, wipe with a dry cloth before using the battery.
For information on installing and removing the battery from the monitor, thoroughly read the user
manual.
The device and accessories are to be disposed of according to local regulations after their useful
lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper
disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage.

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At the end of their life hand the batteries over to the applicable collection points for the recycling
of waste batteries. For more detailed information about recycling of this product or battery, please
contact your local Civic Office, or the shop where you purchased the product.
The equipment does not include elastic cotton band in end product package. The user must buy the
suitable FDA listed or cleared band by themselves.
1.6 Definition and Symbols
Symbol Symbol description
Type B Applied Part
Caution
IP68
This symbol is located on the FHR (Doppler ultrasound) transducer and
the uterine contraction pressure transducer, indicating that this transducer
is waterproof device. Waterproof device: Impervious to or unaffected by
water. The Transducer can work normally in the one-meter deep water for
an hour.
This symbol is located on the instrument’s protective earth terminal,
indicating an Equipotentiality symbol.
Specifies serial number
Equipotential GND
This label is on protective GND terminal of monitor, and it means
protective GND
AC
Label for electric and electronic equipment waste needing separate
disposal (please comply with requirements of local laws)
Refer to instruction manual
NET Communication port
Power indicator
Battery charging indicator
When lithium battery is charging, this indicator will be ON.

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Power key
Press down this key to turn on monitor.
Pressing down this key for certain period will turn off monitor.
Manufacturer

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Chapter 2 Overview of the Instrument
2.1Expected Functions and Purposes
The SRF618B6 Fetal Monitor provides Non-Stress testing for pregnant women from the approximately 28th
week of gestation.
The SRF618B6 Fetal Monitor is intended for non-invasive monitoring of the Fetal Heart Rate (FHRs),
Uterine Activity (UA), and Fetal Movement (FM) during antepartum testing.
Information about fetal heart rate, uterine activity, and fetal movement are all displayed on the monitor and
recorded on recording paper in the form of trajectory graphic.
2.2Configurations
This user manual is written to cover the maximum configuration. The below table list the parameters and
functions that are optional.
2.3Overview
[Fig. 2-1: Front view]
Model Wireless transducers and
the holder Monitoring twin FHRs Monitoring Triplet FHRs Built-in battery
SRF618B6 Optional Optional Optional Optional
1Alarm indicator
2Display screen
3Keys
4Control knob
5Charge, Power indicator
6Paper drawer
7Power key
8Connectors (see Left Side view)

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[Fig.2-2: Left side view]
[Fig. 2-3: Rear view]
[Fig. 2-4: Bottom view]
2.3.1.Keys and Control Knob
Fig. 2-5: Keys
9FHR3 Socket
10 FHR2 Socket
11 FHR1 Socket
12 Fetal Movement Marker (FM) Socket
13 TOCO Socket
14 Wired Transducer Holder(optional)
15 Power cord connector
16 Fuse-holder
17 Handle
18 RS-232 Interface
19 RS-485 Interface
20 RJ45 Interface
21 USB Socket
22 Antenna Interface
23 Battery Component
24 Wall-mounting Holes
23
24

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Fig. 2-6: Control Knob
The Monitor is a user-friendly device with operation conducted by a few keys on the front panel and the
control knob. Their functions are as follows.
1) Keys
Key Name Function Description
Zero key Adjust the external TOCO contractions trace/value to preset unit.
Alarm reset key Disable or enable the ALARM RESET.
Menu key Press this key to enter the main setup menu, including the Fetal
setting, System setting and so forth.
Bed key Press this key to enter the Fetal Monitoring Shortcut Menus
Start/Stop key
Start/Stop monitoring or return to the main interface. Press this key
to start monitoring or stop monitoring.
Print key Start / stop printing
Press this key to start or stop printing.
2) Control knob
Function: Adjust volume, setup and review control.
It can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations on the
screen or in the menu are completed by using the control knob.
The highlighted rectangular mark on the screen that moves with the rotation of the control knob is called
“cursor”. Operations can be performed in the position on the screen where the cursor stays.
When the cursor is located on a certain item, you can press the control knob to enter its submenu or confirm
the operation. Press the control knob again, and the cursor will be able to move around on the
interface/menus.
Operation Procedure:
a) Rotate the control knob to move the cursor to the item you want;
b) Press the control knob;
c) You can rotate the control knob to select the submenu;
d) Press the control knob again, the cursor will move to the next item.
CAUTION:
This monitor is a normal medical device. Please avoid violent operations such as continuously pressing the
keys or control knob.

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2.4Accessories
The accessories should be connected to the monitor via the sockets on the left side and right side panels.
Each accessory has a tab on the connector housing to ensure proper insertion into the appropriate socket on
the monitor.
2.4.1Ultrasound (US) Transducers
Fig 2-7: Wired US Transducer
Front view Back view
Fig 2-8: Wireless US Transducer
2.4.2TOCO Transducers
Fig 2-9: Wired TOCO Transducer
1. Transducer cable
2. US Transducer Sensor
3. Transducer Connector
1
1. Transducer cable
2. TOCO Transducer Sensor
3. Transducer Connector
1
2
3
2
3
Wireless US
Transducer Sensor

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Frontview Backview
Fig 2-10: Wireless TOCO Transducer
2.4.3Fetal Movement Marker
Fig 2-11: Fetal Movement Marker
2.5Screen
2.5.1 Main Interface
Fig 2-12: Main Interface
1. Marker Connector
2. Press key
2
3
4
1. Alarm message window 2. Numeric window
3. Status window 4. Trace/Menu window 5. Fetal monitoring shortcut menus
1
1
2
5
Wireless TOCO
Transducer Sensor

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The main interface of the monitor displays numbers, traces, menus and monitor status information. The
screen background color has three choices: black, green and pink. To change the screen color, please refer to
the section 6.1 System setting 2) Screen Color.
According to the content, the main interface is divided into four windows: (1) Alarm Message Window (2)
Numeric Window (3) Status Window (4) Trace/ Menu Window.
1) Alarm Message Window
Alarm messages displaying area. When an alarm is active, the message will be displayed here. Physiological
alarms will be displayed on the left and technical alarms in the center.
2) Numeric Window
The fetal monitoring numerics are displayed here.
3) Status Window
4) Trace/Menu Window
The trace/menu window occupies most space of the screen. During monitoring or reviewing, it displays
traces; during setting, it displays setup menus.
The background pane bar supports two standards: 30 ~ 240 (American standard) and 50 ~ 210 (International
standard).
The grey band in between the fetal heart rate panes indicates the preset alarm range (the top edge is not
higher than 160 and the bottom edge is not lower than 110). It makes it easy to observe if the FHR exceeds
the normal range. So you can easily tell if the fetal heart rate is too low or too high.
5) Fetal monitoring shortcut menus
Besides, some other symbols appear among the traces:
Zoom in or out
Increase or decrease the FHR traces speed on the scree
Show the traces on the screen forth or back
a) Bed No.
b) Print
c) FHR traces speed on the screen
d) Power indication status
e) Alarm status
f) Operation prompt information
g) System date/time
a b c d e f g

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Print
Turn on the Voice for FHR
Turn off the Voice for FHR
Tools menu, including the submenus of Patient information, Record List, Alarm list and Analysis
result
2.6Ordering Information
Repair parts, along with part numbers, are listed in the tables that follow.
Description Part No.
Monitor:
Power Supply Assembly P4902-03017
Loudspeaker Assembly P4501-08019
Stepper Motor Assembly P4909-03006
Bottom Housing Assembly P2226-04004
Top Cover Housing P2226-04003
Display Assembly P4603-16026
Paper Drawer Assembly P2263-04026
Main CPU Board P1226-02031
Power Cord P5301-00011
Fuse T2AL250V P4904-00004
Rechargeable Lithium-ion Battery of the equipment P4901-01014
Transducers:
Wired Ultrasound Transducer P1221-05031
Wired TOCO Transducer P1224-05040
Wired Fetal Movement Marker P1221-12003
Wireless Ultrasound Transducer P1271-05021
Wireless TOCO Transducer P1271-02055
Rechargeable Lithium-ion Battery of the wireless transducer P4901-01013
Accessories:
Aquasonic Coupling Gel (0.25ltr bottle) P7001-00030
Paper for Recorder(30-240 FHR Scale) P8105-00004
Paper for Recorder(50-210 FHR Scale) P8105-00003
The parts employed by the manufacturer, such as the rechargeable battery, are products have the
characteristics specified by their manufacturers. The materials with which the patient or any other person can
come into contact conform with the standard of ISO 10993.

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CAUTION
Replacement of all above accessories can be performed by the operator. But only the accessories supplied or
recommended by the manufacturer are allowed connected to the monitor.

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Chapter 3 Installation Guide
NOTE:
Installation must be carried out by qualified personnel authorized by the manufacturer.
3.1Unpacking and checking
1) Unpack all external packing for the monitor and its accessories.
2) Check all items according to the Packing List.
3) Check the monitor and its accessories for any damage.
4) If any item is missing or damaged, please contact the consignment unit and our company.
3.2Installing Battery
WARNING:
Switch off the monitor and unplug it before installing or removing the battery.
If your monitor has been configured with a rechargeable lithium-ion battery, follow these steps to install the
battery:
1. Battery Installation
1) Carefully place the monitor upside down on a flat surface covered with cloth or other type of
protecting pad.
2) Remove the screws of the battery compartment using a cross-head screw driver. Remove the
battery compartment cover, and take out the case 1(“1”, shown as Fig.3-1).
3) Plug the battery (2) to the case 1, and then put it into the battery compartment.
4) Shut the battery compartment cover and fix the screws.
Fig.3-1
2. Battery Removal
Fold the LCD display completely flat before turning the monitor upside down. Remove the battery in reverse
order.
NOTE:
If a rechargeable battery is outfitted, charge it fully each time after using the device to ensure the electric
power is enough.
1
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When the battery configuration is provided, after the device is transported or stored, the battery must be
charged. Connecting to power supply will charge the battery no matter if the monitor is powered on.
3.3Installation
The monitor can be placed on a flat surface, or be installed on a wall or a trolley. The service engineer should
install the monitor properly.
NOTE:
When you use this instrument you shall keep a certain distance (more than 300mm) away from other
equipment around, so as to ensure the convenience and safety of the use of this instrument.
3.4Connecting Power Cable
1) Make sure the AC power supply of the monitor complies with the following specification: 100V-240V,
50Hz/60Hz.
2) Apply the power cable provided with the monitor. Plug one end of the power cable to the power socket
of the monitor. Connect the other end to a three-slot power output special for hospital usage.
3) The equipotential grounding terminal is provided for the connection of a potential equalization
conductor. Therefore, it is recommended to connect the grounding terminal of the monitor and the
power outlet with the grounding wire, making sure the monitor is grounded.
WARNING:
If the protective grounding (protective earth) system is doubtful, the power of the monitor must be supplied
by inner power only.
NOTE:
1) Make sure the monitor and the power outlet are placed at a place where it is easy to connect and
disconnect the power cord.
2) When the supply mains is interrupted, the device switches to inner power and operates normally if the
battery is installed. If the battery is not installed, the monitor shuts down and resumes the previous
settings at the subsequent operation.