GEM FLOW COUPLER User manual
FLOW COUPLER Monitor
Global Excellence in Microsurgery
Global Excellence in Microsurgery
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1.
SymbolGlossary per US FD&C Act:
Symbols referenced on labeling
Standard Symbol Symbol Title Symbol Meaning Symbol No.
ISO 15223-1* Manufacturer Manufacturer 5.1.1
ISO 15223-1 Date of manufacture Date of manufacture 5.1.3
ISO 15223-1 Catalogue number Catalogue Number 5.1.6
ISO 15223-1 Serial number Serial number 5.1.7
ISO 15223-1 Temperature Limit Store at controlled room
temperature
5.3.7
ISO 7010** Refer to instruction booklet
(symbol white on blue)
Refer to instruction booklet M002
IEC 60417*** Direct Current Direct Current 5031
IEC 60417 Non-ionizing
electromagnetic radiation
RF Transmitter 5140
IEC 60417 Type CF Applied Part Type CF applied part 5335
Content
Caution: Federal (USA) law restricts
this device to sale by or on the order
of a physician
*ISO 15223-1: Medical Devices – Symbols to be used with medical device labels, labeling and information to be
supplied – Part 1: General requirements
**ISO 7010: Graphical symbols – Safety colours and safety signs – Registered safety signs
***IEC 60417: Graphical symbols for use on equipment
SN
Symbol Symbol Description
Manufacturer part number
Indicates a separate waste
collection is required for
Waste of Electrical and
Electronic Equipment (WEEE)
GTIN number
Power on/o
Made in USA
See IFU for symbol denitions
Additional symbols and graphics on the product labeling that are
not required by the US FD&C Act:
MADE IN THE U.S.A.
PN
GTIN
5012669
Conforms to AAMI STD ES60601-1,
IEC STDS 60601-2-37 & 60601-1-6
Certied to CSASTD C22.2#60601-1
Contains Transmitter Module
FCC ID: VRA-SG9011203
IC: 7420A-SG9011203
SEE IFU FOR SYMBOL DEFINITIONS
2.
Description
The FLOW COUPLER System consists of a FLOW COUPLER Device and a FLOW COUPLER
Monitor. The FLOW COUPLER Monitor is apulsed Dopplerultrasound system designed
for the detection of blood ow in vessels. The FLOW COUPLER Device includes a20MHz
ultrasonic Dopplertransducer (probe) attached to one of the FLOW COUPLER rings, and an
external lead. The probe connects to the Monitor via the external lead and emits a pulsed
ultrasonic signal. An audible signal of varying volume strength is produced when the probe
detects ow.
Indications For Use:
The FLOW COUPLER Device is a single use, implantable device that is intended to be used
in the end-to-end anastomosis of vein and arteries normally encountered in microsurgical
and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of
permanently implanted rings which secure the anastomosis and a removable Doppler
probe that is press-t onto one of the rings. Whenthe FLOW COUPLER Device is used in
conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to
detect bloodow and conrm vessel patency intra-operatively and post-operatively at the
anastomoticsite. Post-operatively, blood ow can be detected on an as-neededbasis for up
to 7 days. The FLOW COUPLER Doppler probe isnot intended to be apermanent implant
and shouldbe removed 3 to 14 days post-operatively.
Contraindications:
The FLOW COUPLER Monitor isnot intended specically to diagnose, monitor or correct a
defect of the heart or the central circulatory system.
WARNINGS:
• If procedures are not followed, injury may occur.
• Do notperform servicing and maintenance while the Monitor is in use. Severe device
damage may occur.
• FLOW COUPLER Monitor is not sterilizable. Never sterilize the FLOW COUPLER Monitor
with autoclave, ultraviolet, gamma radiation, gas, steam, or heat sterilization techniques.
Severe device damage and/or injury may occur.
• The Monitor should not contact mucus membranes, blood, or compromised tissue, and is
not used insterile elds. Severe device damage may occur.
• Not for use in OXYGEN ENRICHED atmospheres to reduce re and explosion risk.
• Do not remove internal rechargeable lithium ion battery pack. Severe device damage
may occur. If required, return the Monitor to the manufacturer for the battery replacement.
• Monitor not suitable for use in the presence of a ammable anesthetic mixture with air
or with oxygen ornitrous oxide. Fire or explosion may occur.
CAUTIONS:
• If procedures are not followed, possible equipment or software damage may occur.
• The FLOW COUPLER System may be susceptible to picking up interference through the
coaxial cable that connects the probe to the Monitor. Do not use in the presence of any
highfrequency equipment, including highfrequency surgical generators.
• The FLOW COUPLER Monitor may turn o or lose LCD touch screenfunction due to
electrostatic discharge interference. Turn on the Monitor and Monitor’s function to
generate audible sounds and hardware control using buttons should not be impacted.
• Only use Monitor with FLOW COUPLER devices. Monitor may not function properly
and device damage may occur.
•
Only use FLOW COUPLER AC Power Supply included with the COUPLER Monitor (GEM1020M-2)
or Power Supply sold separately (GEM1020PS-2). Severe device damage may occur.
• During the use of all ultrasound devices, the operator shouldminimize the exposure of
ultrasound energy to the patient using the principle of ALARA (As Low As Reasonably
Achievable).
• No modication of this equipment is allowed. Severe device damage may occur.
• The FLOW COUPLER Monitor isintended for use by healthcare professionals only.
• The FLOW COUPLER Monitor and System may cause radio interference or may disrupt the
operation of nearbyequipment.
•
•
Avoid obstructing with the audio output from the speakers located on sides of the Monitor.
Audio volume and quality may be negatively aected.
Do not use any chemicals other than those listed within the cleaning instruction of this IFU
for cleaning of the Monitor. Severe device damage may occur.
• Avoid usage of the FLOW COUPLER Monitor adjacent to or stacked with other equipment
because it may result in inoperable Monitor. If such use is necessary, observe to verify
FLOW COUPLER Monitor and the other equipment are operating normally.
• Only use accessories (FLOW COUPLER Device and FLOW COUPLER Monitor Power Supply)
as specied in this Instruction For Use with the FLOW COUPLER Monitor because usage with
unspecied accessories may lead to increased electromagnetic emissions or decreased
electromagnetic immunity of the Monitor.
• Do not use portable RF communications equipment (including peripherals such as antenna
cables and external antennas) no closer than 30cm (12 inches) to any part of the FLOW
COUPLER Monitor and accessories (FLOW COUPLER Device and FLOW COUPLER Monitor
Power Supply). Otherwise, degradation of the performance of the Monitor may occur.
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Figure 1: FLOW COUPLER Monitor Description
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2
3
9
45
8
710
PRODUCT SPECIFICATIONS
Hardware Controls (see Figure 1):
(1) Power Button:Turns the unit ON. Power ON is indicated by illumination of buttons
and the LCD screen. When the push-button is depressed (and momentarily held) a second
time the unit is turned OFF.
(2) Audio Volume Increase Button: Increase the volume of the audible Doppler signal.
Output from the speakers located on sides of the Monitor.
Output from the speakers located on sides of the Monitor.
(3) Audio VolumeDecrease Button: Decrease the volume of the audible Doppler signal.
(4) Mute Button:Mutes the sound.
(5) Channel SelectionButtons: Setsthe Doppler to a channel. The selected channel button will
be illuminated.
(10) Settings Menu:
(11) Visual Indicator of Audible Sound
Touch the icon to access the Settings menu.
LCD Controls (See Figure 1):
(6) Volume Indicator:A graduated scale in the LCD screen indicates the volume of the audible
Dopplersignal. Volume can be changed by touch-and-drag the scale on the touchscreen.
Component Interfaces (See Figure 1):
(12) Power Supply connector: Connect Power Supply to the Monitor.
(13) External lead connector: Connect external lead(s) to the Monitor. Up to 2 external leads
can be connected to the Monitor.
(7) Mute Indicator:The icon indicates the mute status. Touch the icon to change the mute status.
(8) Channel Selection Indicator: Conrms the channel selected. Touch the icon to change the channel.
(9) Battery Indicator:Displays the battery charge level.
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1
12
50%
Channel B
11
3.
During the battery charge,
a charging status icon is
displayed.
When the battery level is
below 10%, critically low
battery screen appears and
Monitor beeps. Monitor will
automatically shut OFF
shortly after reaching the
battery charge level of 10%.
NOTE: Immediately plug
Monitor into power supply
and wall outlet to charge
the battery.
Settings: Touch the settings mode icon
on the screen to display and/or change
additional settings for: Volume settings
Display settings, System information and
Language section.
!!! BATTERY CRITICALLY LOW !!!
Battery Charge Required
4.
Selecting Volume button in
the settings screen opens
Volume Settings screen.
Volume Settings Screen
contains two sliderswhere
you can change the volume
of the keyboard tone when
the Monitor volume is
active (top bar) and when
the Monitor volume is
muted (bottom bar).
Wi-Fi Selection
Home
Home255
Home748
Press to select.
Press and hold to edit.
Volume Settings
Keyboard Tone Volume
Keyboard Tone Volume (muted)
Settings
Display
System
Language
Volume
When the battery level falls
below 20%, the icon turns
orange.
NOTE: Immediately plug
Monitor into power supply
and wall outlet to charge
the battery.
95%
Channel B
20%
Channel B
Selecting Display button in the
settings screen opens Display
Settings screen. Display
Settings Screen contains two
sliderswhere you can change
the Normal Brightness or the
Dimmed Brightness and the
duration of the brightness(Dim
Timeout Seconds) by toggling
the Seconds Button (10, 15, 20,
30, 45, 60, 90, or 120).
Selecting System button in the
settings screen opens System
screen. System Screen contains
technical specications including
versions of the hardware and
software, and the date and time.
Display Settings
Normal Brightness
Dimmed Brightness
Dim Timeout 60 Seconds
System
K70 Ver:
BL Ver:
Date / Time:
0.0.0.0
0.0.0.0
2021-02-16 22:23:24Z
Visual Indicator of
Audible Sound:
The visual indicator is a
secondary feedback of the
audible sound, which is the
primary indicator of the
blood ow.
Visual Indicator of Audible Sound
5.
Language
EN ES TR PL
FR NL NO
DE DA PT
IT SV EL
Selecting Language button
in the settings screen opens
Language Screen. Language
Screen allows user to select
language for the device
screen. (Currently only
English is available.)
Operation:
Icons of states:
Battery
Transmission Frequency: 20 MHz
Charging
Using battery
Need charging
TransmissionCharacteristic: Pulsed transmission, continuous reception
Sensitivity: See FLOW COUPLER Device and System IFU
Environment:
Recommended shipping and storage temperature: 50C to 40, non-condensing.
Avoid direct sunlight
IPX 0 (Monitor): No special protection
Power:
Class II External Power Supply shippedwith the Monitor or sold separately (GEM1020PS-2),
A/C to D/C Power Supply Internally rechargeable Lithium Ion Battery, Power Requirements:
12 VDC
Physical:
Dimensions: 8.2inL x5.7in W x 2.8inH. (216 mm x 127 mm x 99 mm)
Weight: 1.84 lb, (0.835 kg)
100%
90%
20%
Instructions for Use (Intraoperative Monitoring):
6.
1. Carefully unpack your FLOW COUPLER Monitor. Inspect the Monitor for damage. If the
Monitor isdamaged, contact the manufacturer for furtherinstructions.
Handle the Monitor with caution to prevent damages and the handle is provided for safe
handling of the Monitor.
2.
Place the Monitor on a suitable stand, cart or table outside the sterile eld, near the
physician who will be using the FLOW COUPLER System, and within 4 feet of the patient.
Avoid using the Monitor in the presence of any high frequency equipment (e.g. High
frequency surgical generator, cordless phone). The Monitor has a rating of IPX-0. Keep the
Monitor away from all open liquids.
NOTE:If the external leadis nearelectrically active conductors, suchas electro-surgery
cables orelectronic equipment, signals from the cables or electronic equipment may be
picked up by the Monitor and produce undesired audible signals. This interference is easily
distinguished from bloodow andis remedied by moving the external leadaway from the
source of the interference.
3.
Connect the Power Supply provided withthe Monitor or sold separately
(GEM1020PS-2) to the Monitor. Connect the Power Supply to the appropriate adaptor
plugs suppliedwith the Power Supply. Connect the adaptor plug to a grounded
hospital grade outlet. The Monitor contains internally rechargeable batteries.
If charged, use of the Power Supply is not required, but recommended, for the
operation of the Monitor.
NOTE:Patient isolationfrom the AC power is accomplished inthe following ways: The DC
power output lines from the power supply are isolated from the mains in the DC power
supply. There is no connection between the “green” safety ground and the Monitor. The
nal isolation mechanismis the cable insulationand potting of the probe that provides an
additional insulation layer betweenthe isolated electrical signals and the patient.
4.
Turn the Monitor on by depressing the Power Button located on the back of the Monitor.5.
6. Check for the batterylevel shown in upper right portion of the LCD screen. Connect the
Power Supply to the Monitor as instructed in Step 4, if desired.
NOTE: If the battery level is below 20%, it is recommended to recharge the Monitor using the
Power Supply.
7. Refer to FLOW COUPLER Device and System Instructions for Use for handling of the
FLOW COUPLER Device.
8. Transfer the free connector of the external lead (supplied with the FLOW COUPLER
device) outside the sterile eld. Insert this free connector into either Channel
receptacle A or Channel receptacle B on the front side of the Monitor.
NOTE: If more than one lead is to be used, it may be helpful to label the leads to facilitate
identication (e.g. Lead A, Lead B)
9. Ensure that correct Channel Selection Button is illuminated, and Channel Selection
Indicator on the LCD screenisdisplayed.
10. Listen for blood ow. Some background noise may be audible.
NOTE: If blood ow is not detected withthe Monitor, rely onclinical indications for patient
status. Ischemia or reperfusion rate may delay or aect the initial Doppler signal.
11. Adjust the volume by depressing and holding the Volume Increase Button or Volume
Decrease Button to the desired level. If a strong audible signal is not identied, irrigate
the anastomotic site with saline and ensure the probe tip is in contact with the vessel.
During irrigation, an audible signal from the Monitor veries properfunction of the
device.
12. Turn o the Monitor after use by depressing the Power Button.
NOTE:It is advised that the Monitor be connected to the Power Supply whenever possible.
Instructions for Use (Postoperative Bedside Monitoring):
7.
Disconnect the Power Supply from the electrical outlet.
Transport the patient with the Monitor and the Power Supply to postoperative care area:
use the handle on the Monitor to prevent damages and for safe handling of the Monitor.
Repeat steps 3 to 7 outlined in Intraoperative Monitoring Instructions for use.
Ensure the external lead is connected to the probe and the Monitor and the Power
Supply is connected to the Monitor or battery power is used during the transportation of
the Monitor.
NOTE: It is advised that the Monitor is connected to Power Supply whenever possible.
Ensure that correct Channel Selection Button is illuminated, and Channel Selection
Indicator on the LCD screen is displayed.
Listen for blood ow. Some background noise artifacts from the Monitor may be audible.
NOTE: If blood ow is not detected with the Monitor, rely on clinical indications for patient status.
NOTE: Doppler signal may vary during monitoring period.
When Monitor is not being used to detect ow, external lead may be disconnected from
the probe by pulling probe connectors apart and external lead remain connected to the
Monitor.
Turn o the Monitor after use by depressing the Power Button.
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2.
3.
4.
5.
6.
7.
8.
Special instructions:
Maintenance and Cleaning: The Monitor has a useful life of 5 years. The Monitor contains no user
serviceable components and requires no maintenance or calibration. Keep itcleanand free of dust.
The exterior may be cleaned using the following steps:
1. After every use, check the Monitor for any sign of damage or wear. Remove any external lead still
connected in the A or B ports and discard per local procedures.
2.
Wipe the Monitor with a dry or water-moistened soft cloth, Isopropyl Alcohol, Ammonium
Hydroxide based surface cleanser, Ammonium Chloride based surface cleanser or 2% bleach solution.
Ensure any residual organic material is removed. Do not pour or spray liquid directly on the Monitor.
Allow to air dry before use.
3. Do not put liquid near the speaker.
4. The FLOW COUPLER Monitor is no longer usable when hardware buttons, LCD screens are
inoperable, or audible signal is not generated when connected to the FLOW COUPLER probe.
The Following Sections apply to the FLOW COUPLER 20MHz Doppler Probe
Acoustic Output: There are no user controls meant to aect acoustic outputs. All acoustic outputs are
below the application specic pre-amendments acoustical output limit of anIspta of 94 mW/cm2and
a MIof 1.9.
Explanation of Derivation of Derating Factor: The derated intensity calculations are basedon
measured center frequency of the acoustical signal (f, MHz) and the distance from the transducer
under test to the hydrophone (z, cm)using the derating factor e.
-0.069 fz
Track 1summary
System:FLOW COUPLER Monitor and Probe System
Monitor: FLOW COUPLER Monitor
Symbol Index
PWD: Pulsed Wave Doppler
MI Mechanical Index
TIS Soft Tissue Thermal Index
TIB Bone Thermal Index
TIC Cranial Bone Thermal Index
Pr,a Attenuated Peak-Rarefractional Acoustic Pressure
PPower Output
P1x1 Power Output through 1cm2of area
zsDepth for TIS
zbDepth for TIB
ZMI Depth for Mechanical Index
Zpii,a Depth for Peak Attenuated Pulse Intensity Integral
fawf Acoustic Working Frequency
prr Pulse Repetition Rate
srr Scan Repetition Rate
npps Number of Pulses per Ultrasonic Scan Line
Ipa,a Attenuated Pulse-Average Intensity
Ispta,α Attenuated Spatial-Peak Temporal Average Intensity
zsii,α Depth for Peak Sum of Attenuated Pulse
Ispta Spatial-Peak, Temporal-Average Intensity
zpii Depth for Peak Pulse-Intensity Integral
zsii Depth for Peak Sum of Pulse-Intensity Integral
prPeak-Rarefractional Acoustic Pressure
Clinical Application B M PWD CWD Color
Doppler
Combined
(Specify)
Other
(Specify)
Ophthalmic
Other (intra-operative
and post-operative) X
Cardiac
Clinical Application
Mode of Operation
8.
STORAGE CONDITIONS:
Recommended shipping and storage at 5°C - 40°C, non-condensing
Avoid direct sunlight
Acoustic output format for track 1:
Non-Autoscanning Mode
System:FLOW COUPLER Monitor and Probe System
Operating Mode:PW Doppler
Transducer Model: 20 MHz Doppler Probe
Application(s): Other (intra-operative and post-operative)
Index Label
Maximum index value
Index component value
Associated
acoustic
parameter
Other
Information
Operating
Control
Conditions
Single mode XX X X X
MI TIS TIB TIC
At
Surface
Below
Surface
At
Surface
Below
Surface
0.0105
0.0470
9.80E-4 5.14E-3
9.80E-4 7.98E-4 5.14E-3 1.90E-3
1.03E-2
1.03E-2
1.03E-2
1.03E-2
-
-
-
0.15
0.15
0.15
0.15
20.0 20.0 20.0 -
78000
78000
1
3.44
4.24
4.24
0.0470
(cm)
(cm)
(cm)
(cm)
(MHz)
(Hz)
(Hz)
(mW)
(mW)
(MPa)
(MPa)
(W/cm2)
(mW/cm2)
(mW/cm2)
P
P1x1
Pr,a at ZMI
zs
zb
ZMI
Zppi, a
fawf
prr
srr
npps
Ipa, a at zpii, a
Ispta, a at zppi, a or zsii, a
Ispta at zpii or zsii
Prat zpii
9.
Performance Criteria
Failures include any time the unit does not produce an audible signalwhen detectable ow is present.
In addition to component malfunction, failures also include units that produce afalse audible that is
indistinguishable from a signalproduced by ow. Non-intentional audible signal tones are allowed to be
produced by the unit, solong as they cannot be easily mistaken for ow.
The equipment or system may exhibitperformance degradation (e.g., deviation from specications) that does
not aect essential performance or safety.
Guidance and manufacturer’s declaration – electromagnetic emissions
in such an environment.
Emission Test Compliance Electromagnetic Environment - guidance
RF Emissions, CISPR 11:2015 +A1:2016 Group 1 The FLOW COUPLER Monitor system uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions, CISPR 11:2015 +A1:2016
Harmonic Current Emissions
IEC 61000-3-2:2014
Voltage Fluctuations and Flicker
IEC 61000-3-3:2013
Class A
Class A
Complies
The FLOW COUPLER Monitor meets the conducted and radiated performance requirements for non-life supporting
supporting equipment pursuant to IEC 60601-1-2:2014.
NOTE: The EMISSIONS characteristics of the FLOW COUPLER Monitor make it suitable for use in industrial areas and
hospitals (CISPR 11 class A).
10.
Guidance and manufacturer’s declaration – electromagnetic immunity
in such an environment.
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic Discharge
IEC 61000-4-2:2008
± 8kV contact
± 2kV, ± 4kV, ± 8kV, and ± 15kV air
± 8kV contact
± 15kV air synthetic material, the relative humidity should be at least 30%. The Monitor
LCD screen may icker or restart. The function of generating audible signal is
not impacted. The Monitor may turn o or lose LCD touch screen function due
to electrostatic discharge interference functioning. Turn on the Monitor and
Monitor’s function to generate audible sounds and hardware control using
buttons should not be impacted.
Radiated RF Immunity
IEC 61000-4-3:2006/AMD2:2010
Proximity elds from
RF wireless equipment
IEC 61000-4-3:2006/AMD2:2010
3V/m, 80-2700MHz,
80% 1kHz AM,
80-2700MHz,
80% 1kHz AM
Section 8.10, Table 9
of the IEC 60601-1-2:
Edition 4.1 standard
Section 8.10, Table 9
of the IEC 60601-1-2:
Edition 4.1 standard
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be no closer than 30cm
(12 inches) to any part of the FLOW COUPLER Monitor and accessories
(FLOW COUPLER Device and FLOW COUPLER Monitor Power Supply).
Field strengths from xed RF transmitters, as determined by an
electromagnetic site survey,
ashould be less than the compliance level in each
frequency range.bInterference may occur in the vicinity of equipment marked
with the following symbol:
Electrical Fast Transients and
Bursts Immunity
IEC 61000-4-4:2012
2kV, 100kHz repetition rate 2kV Mains power quality should be that of a typical commercial or hospital envi-
ronment. The FLOW COUPLER Monitor may go into the charging state due to
transient disturbance. It will require manual reset of the Monitor by pressing
power ON button. It does not impact the Monitor’s function to generate
Surge Immunity
IEC 61000-4-5:2014/AMD1:2017
± 0.5kV, ± 1kV for line-to-line
± 0.5kV, ± 1kV, ± 2kV
for line-to-ground
± 0.5kV, ± 1kV for line-to-line
± 0.5kV, ± 1kV, ± 2kV
for line-to-ground
Mains power quality should be that of a typical commercial or hospital
environment.
Conducted Disturbances,
Induced by RF Fields Immunity
IEC 61000-4-6:2013
3V, 0.15-80MHz, 80% 1kHz AM
6V in ISM Band within 0.15-80MHz,
80% 1kHz AM
3V Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be no closer than 30cm (12 inches) to any
part of the FLOW COUPLER Monitor and accessories (FLOW COUPLER Device and
FLOW COUPLER Monitor Power Supply).
Power Frequency Magnetic Field
Immunity
IEC 61000-4-8:2009
30A/m, 50Hz or 60Hz 30A/m, 50Hz and 60Hz
locationina typical commercial or hospital environment.
11.
3V/m, 80-2700MHz,
80% 1kHz AM,
80-2700MHz,
80% 1kHz AM
Voltage Dips Immunity
IEC 61000-4-11:2004 / AMD1:2017
Voltage Interruptions Immunity
IEC 61000-4-11:2004 / AMD1:2017
Immunity to Proximity Magnetic Fields
0% (100% reduction), 0.5 cycle
0% (100% reduction), 1 cycle
70% (30% reduction) UT, 0.5 sec
0% (100% reduction), 5 sec
Section 8.11, Table 11 of the
IEC 60601-1-2: Edition 4.1 standard
0% (100% reduction), 0.5 cycle
0% (100% reduction), 1 cycle
70% (30% reduction) UT, 0.5 sec
0% (100% reduction), 5 sec
Section 8.11, Table 11 of the
IEC 60601-1-2: Edition 4.1
standard
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the FLOW COUPLER Monitor requires continued
operation during power mains interruptions, it is recommended that the
FLOW COUPLER Monitor system be powered from an uninterruptible power
supply or the built-in battery.
Immunity to proximity magnetic elds in the frequency range 9kHz to
13.56MHz was evaluated.
NOTE 1: UT is the a.c. mains voltage prior to application of the test level.
NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.
a
strength in the location in which the Doppler system is used exceeds the applicable RF compliance level above, the Doppler system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Doppler system.
b
Protocol: 802.11b/g/n
Modulation: DSSS, OFDM
Wireless band: 2.4GHz
Max data rate possible: 72.2Mbps
Max power output possible: 16dBm
Sensitivity: -98dBm
12.
13.
Troubleshooting Guide (Bedside Monitoring)
Symptom Possible Problem Solution
Weak sound output
No sound output
LCD touch
screen malfunction
Monitor not functioning
Monitor power is o
Power Supply disconnected and the
Battery level critically low
Volume is too low
Monitor not functioning
LCD touch screen unresponsive
Volume is muted
Wrong channel is being used
Probe Disconnected
There are no user serviceable components inside this device. Disassembly of the internal components of this unit may result in circuit damage.
Signal Interference/
feedback
Monitor location is too close to electrosurgical generator
Monitor speaker outputs noise from interfering equipment
If Monitor does not power on, connect the Power Supply to the Monitor.
Check connections:
• Monitor to Power Supply
• Power Supply to Adaptor Plug
• Adaptor Plug to outlet
Unmute the Monitor by pressing Mute button or Mute Indicator on the LCD screen.
Increase volume by pressing Volume Increase Button or touch-and-drag Volume Indicator on the LCD screen.
Verify the correct channel button is illuminated and the correct channel is displayed on the LCD screen.
Check connections:
• Probe Connector to External Lead
• External Lead to Monitor
Connect a dierent FLOW COUPLER Monitor.
Contact Synovis Micro Companies Alliance Customer Service (Ph. +1 205.941.0111 or +1 800.510.3318 (U.S. only).
Increase volume by pressing Volume Increase Button or touch-and-drag Volume Indicator on the LCD screen.
Connect a dierent FLOW COUPLER Monitor.
Contact Synovis Micro Companies Alliance Customer Service (Ph. +1 205.941.0111 or +1 800.510.3318 (U.S. only).
Power o and on the Monitor.
Contact Synovis Micro Companies Alliance Customer Service (Ph. +1 205.941.0111 or +1 800.510.3318 (U.S. only).
Turn on Monitor.
Move Monitor away from generator to location that does not result in interference.
Move Monitor to new location in room.
14.
SERVICE:
For Customer or Technicalservice, contact:
Phone: +1 205.941.0111 or1.800.510.3318 (U.S. only) • Fax: + 205.941.1522
Website: synovismicro.com
ACCESSORIES & PARTS
LIMITED WARRANTY
The FLOW COUPLER Monitor is warrantied for one yearfrom the date of shipment from Synovis MCA against defects in materials and workmanship. Defective GEM FLOW COUPLER
Monitorswill be repaired or replaced, at Synovis MCA’s option, when returned prepaid to Synovis MCA within this year. The customer assumesfull responsibility that this equipment
meets the specications, capabilities and other requirements of the customer. SynovisMCA makes no warranty of tness for aparticular purpose except as providedherein. The customer
assumesfull responsibility for the proper installation, operationand maintenance of this equipment as described in this manual as well as other instructions that may be provided by
Synovis MCA. This warranty is voidif the equipment has been mishandled, operated outside of its specied operating or environmental limits or otherwise subjected to improper or
abnormaluse.
Item
FLOW COUPLER Monitor GEM1020M-2
Power Supply GEM1020PS-2
FLOW COUPLER Device 2.0 GEM2752-FC
FLOW COUPLER Device 2.5 GEM2753-FC
FLOW COUPLER Device 3.0 GEM2754-FC
FLOW COUPLER Device 3.5 GEM2755-FC
FLOW COUPLER Device 4.0 GEM2756-FC
External Lead, 4-pack GEM1003EXT-FC
Monitor and power supply may be returned to manufacturer for proper disposal or dispose of in accordance with local ordinance.
MONITOR AND POWER SUPPLY DISPOSAL:
NA
245cm (96.5 inches)
43cm (17 inches)
43cm (17 inches)
43cm (17 inches)
43cm (17 inches)
43cm (17 inches)
198cm (78 inches)
Cable Length
15.
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16.
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Global Excellence in Microsurgery
17.
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Global Excellence in Microsurgery
Global Excellence in Microsurgery
Global Excellence in Microsurgery
Flow Coupler and the GEM design are trademarks of Baxter International Inc., or its subsidiaries. MS-14093, Rev H
2022-10-30
Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International Inc.), 439 Industrial Lane,
Birmingham, AL 35211-4464 USA. (Tel) 205.941.0111 (Toll free) 800.510.3318 (Fax) 205.941.1522
www.synovismicro.com
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