GE Healthcare MINITEL2010 Mini Telemetry System Tx User Manual

GE Healthcare Mini Telemetry System Tx

User Manual

Mini Telemetry
Operation and Maintenance Manual
GE Healthcare
To order this manual, please refer Appendix A for
correct language listing.
Copyright 2010 by General Electric Company.
All rights reserved.
2049809-001 Rev B.
All rights reserved. General Electric Company reserves the right to make changes in specications and features
shown herein, or discontinue the product described at any time without notice or obligation. Contact your GE
Representative for the most current information, Corometrics is a trade mark owned by GE Healthcare and GE
monogram are trademarks of General Electric Company. All other company and product names mentioned may
be trademarks of the companies with which they are associated.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B iii
Contents
About this Manual ........................................................................................................... vii
User Responsibility .................................................................................................................................................... vii
Conventions ................................................................................................................................................................. viii
Denition of Terms Used ....................................................................................................................................... viii
Symbol Denitions ...................................................................................................................................................... ix
Chapter 1: Product Description ...................................................................................... 1
Product Denition ........................................................................................................................................................ 1
Indications for Use .......................................................................................................................................................1
Product Features .......................................................................................................................................................... 2
Chapter 2: Safety ............................................................................................................... 3
General Information .................................................................................................................................................. 3
General Use ....................................................................................................................................................................3
Responsibility of the Manufacturer ....................................................................................................................3
Equipment Safety Information...............................................................................................................................4
FCC Information (USA) ................................................................................................................................................8
FCC Rules Compliance ......................................................................................................................................8
FCC RF Exposure Compliance .......................................................................................................................8
FCC Service Information .................................................................................................................................. 8
Wireless Medical Telemetry Service (USA) ...............................................................................................8
Industry Canada Information ................................................................................................................................9
Transmitter Antenna ........................................................................................................................................ 9
Interference ..........................................................................................................................................................9
Wireless Medical Telemetry Service ..........................................................................................................9
CE Marking Information Compliance ..................................................................................................................9
R&TTE directive .......................................................................................................................................................... 10
Chapter 3: Mini Telemetry Components .....................................................................11
Transmitter ................................................................................................................................................................. 11
Oblique View ...................................................................................................................................................... 11
Side View .............................................................................................................................................................. 13
Battery Compartment.................................................................................................................................... 14
Display GUI .......................................................................................................................................................... 15
iv 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Table of Contents
Display Indications .......................................................................................................................................... 15
Receiver ......................................................................................................................................................................... 16
Receiver Front Panel ....................................................................................................................................... 16
Receiver Rear Panel ........................................................................................................................................ 17
Chapter 4: Installation and Setup ................................................................................19
Connecting the Receiver and Monitor ........................................................................................................... 19
Setting up the Transmitter ................................................................................................................................... 21
Connecting Battery to Circuit Board ....................................................................................................... 21
Connecting Power Adaptor ......................................................................................................................... 22
Replacing the Plug Attachments .............................................................................................................. 23
Attaching the Carrying Strap ...................................................................................................................... 23
Performing a Functional Checkout .................................................................................................................. 24
Initial Conditions .............................................................................................................................................. 24
Testing the Radio Frequency ...................................................................................................................... 24
Testing the Ultrasound Functions ........................................................................................................... 25
Testing the ECG Functions ........................................................................................................................... 26
Testing the UA Functions .............................................................................................................................. 27
Testing the Event Marker Function .......................................................................................................... 29
Testing the Environment ............................................................................................................................. 29
Monitoring via Telemetry ....................................................................................................................................... 30
Suggestions for Ambulatory Monitoring ............................................................................................... 30
Monitoring Reminders ............................................................................................................................................ 31
General ................................................................................................................................................................. 31
Ultrasound ......................................................................................................................................................... 32
FECG ...................................................................................................................................................................... 32
Tocotransducer ................................................................................................................................................ 32
IUPC ....................................................................................................................................................................... 32
Chapter 5: Maintenance and Cleaning .......................................................................33
Maintenance ............................................................................................................................................................... 33
Storage ................................................................................................................................................................. 33
General Cleaning Precautions ................................................................................................................... 33
Cleaning the Transmitter and Receiver ................................................................................................. 33
Shoulder Strap Cleaning ............................................................................................................................... 34
Chapter 6: Troubleshooting ..........................................................................................35
Problem Chart............................................................................................................................................................. 35
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B v
Table of Contents
Appendix A: Supplies and Accessories ........................................................................41
Appendix B: Technical Specications ..........................................................................43
B.1 Transmitter ........................................................................................................................................................... 43
B.2 Receiver ................................................................................................................................................................. 48
Appendix C: Electromagnetic Compatibility ..............................................................51
C.1 Electromagnetic compatibility (EMC) guidance................................................................................... 51
C.2 Manufacturer’s guidance and declaration regarding electromagnetic immunity ............ 51
Appendix D: Warranty ....................................................................................................55
vi 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Table of Contents
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© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B vii
About this Manual
Before using the Mini Telemetry System with your Corometrics Fetal Monitor, read this entire manual. As with all
medical equipment, attempting to use this device without a thorough understanding of its operation may result
in patient or user injury. This device should only be operated by personnel trained in its operation and familiar
with the risks and benets of this type of device. Additional precautions specic to certain procedures are found
in the text of this manual.
User Responsibility
This Product will perform in conformity with the description contained in this Operation and Maintenance manual
and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance
with the instructions provided. This Product must be checked periodically. A defective Product should not be
used. Parts that are broken, missing, partially worn, distorted, or contaminated should be replaced immediately.
Should such repair or replacement become necessary, GE Healthcare recommends that a telephonic or written
request for service advice be made to the nearest GE Healthcare Regional Service Center. This Product or any of
its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare
and by GE Healthcare trained personnel. The Product must not be altered without GE Healthcare’s prior written
approval. The user of this Product shall have the sole responsibility for any malfunction that results from improper
use, faulty maintenance, improper repair, damage, or alteration by anyone other than GE Healthcare. Do not
use this product without prior site survey and awareness of the standard medical frequency bands that can be
congured for this Telemetry system.
GE Healthcare has declared that this product conforms with the
European Council Directive 93/42/EEC Medical Device Directive when
used in accordance with the instructions provided in this Operation and
Maintenance Manual.
U.S. Federal law restricts this device to sale by or on the order of a licensed
medical practitioner.
viii 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
About this Manual
Conventions
Various types of pictures or icons are used in this manual wherever they reinforce the printed message to alert
you to potential safety hazards.
The warnings and cautions in this section relate to the equipment in general and apply to all aspects of the
equipment. Be sure to read the other chapters as they contain additional warnings and cautions that relate to
specic features of the equipment.
When grouped, warnings and cautions are listed alphabetically and do not imply any order of importance.
WARNING:
A DANGER notice indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
CAUTION:
A CAUTION indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury. Cautions are also used to avoid damage
to equipment.
SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION
An Electrostatic Discharge (ESD) Susceptibility symbol is displayed to alert service
personnel that the part(s) are sensitive to electrostatic discharge and that ESD
control guidelines must be followed to prevent damage to the equipment.
NOTE: A Note provides important information about an item or a procedure. Information contained in Notes can
often save you time or eort.
Denition of Terms Used
The denitions of terms used in this manual are listed in the following table:
Term Denition
ECG Electrocardiogram
MECG Maternal Electrocardiogram
FHR Fetal Heart Rate
UA Uterine Activity
TOCO Non invasive method of measuring uterine activity
IUPC Intra-Uterine Pressure Catheter
RF Radio Frequency
BPM Beats Per Minute
FECG Fetal Electrocardiogram
WMTS Wireless Medical Telemetry System
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B ix
About this Manual
Term Denition
ESD Electro Static Discharge
BNC Bayonet Nut Connector
Symbol Denitions
This section identies the symbols that are displayed on the Mini Telemetry.
Symbol Denition
Refer to instruction manual / booklet.
Protective earth terminal
Alternating current
European Union representative
Serial number
Manufacturer
Equipment shall be used only by qualied, trained medical personnel
Non-sterile
Waste of electrical and electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately
Ground Equalization Potential Post
E CR E P
SN
x 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
About this Manual
Symbol Denition
Battery Runtime Indicator
IEC TYPE B EQUIPMENT. Type B equipment is suitable for intentional, external
and internal application to the patient, excluding direct cardiac application.
IEC TYPE BF EQUIPMENT. Type BF equipment is suitable for intentional external
and internal application to the patient, excluding direct cardiac application.
Type BF equipment has an F-type applied part.
IEC TYPE CF EQUIPMENT: Type CF equipments provide the highest degree of
patient protection. This degree of protection is achieved by increased isolation
from earthed parts and other accessible parts of the equipment, further limiting
the magnitude of possible current ow through the patient. Type CF applied
parts are suitable for direct cardiac application.
DEFIBRILLATOR-PROOF TYPE BF EQUIPMENT: Type BF equipment is suitable for
intentional external and internal application to the patient, excluding direct
cardiac appliction. Type BF equipment is type B equipment with an F-type
isolated (oating) part. The paddles indicate the equipment is debrillator proof.
0POWER OFF: disconnection from the mains.
IPOWER ON: connection to the mains.
1. Use Transducer in a watery environment only when connected to a telemetry
system. Do not allow the telemetry system to get wet.
2. Do not use transducer in a watery environment when directly connected to
a fetal/maternal monitor that is directly connected to AC line power.
Date of Manufacture (in “YYYY-MM” format)
Elevated, potentially hazardous levels of non-ionizing radiation.
Ultrasound
ECG
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B xi
About this Manual
Symbol Denition
Uterine Activity
Class II equipment according to IEC 61140.
CE Mark for devices to be sold in the EU.
Electrical equipment which is not suitable for a residential area (e.g. equipment
which produces radio interference when in operation).
Prescription Device Label for United States.
Unique Identication number from FCC and Industry Canada.
Medical Equipment
With respect to electric shock, re and mechanical hazard only in accordance
with UL.
Direct Current for products to be powered from DC supply.
Mark key symbol.
Speaker Symbol ( IEC 5080 symbol).
xii 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
About this Manual
Transmitter Power ON / OFF (IEC 5010 symbol).
Audio head set (IEC 5077 symbol).
Fuse Symbol (IEC 5016 symbol).
Antenna Symbol (IEC 5039 symbol).
To identify a connector for a serial data connection.
Named as “ J2 “ on the Receiver back panel (IEC 5850 symbol).
To identify an output terminal when it is necessary to distinguish between inputs
and outputs.
Named as “J1 “on the Receiver back panel (IEC 5035 symbol).
Signal Strength Indicator on receiver front panel.
Battery Symbol on Receiver front panel (ISO 0247 symbol).
Temperature limitations in which the transport package has to be kept and
handled.
Humidity limitations in which the transport package has to be kept and handled.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B xiii
About this Manual
Pressure limitations in which the transport package has to be kept and handled.
NOTE: Mini-telemetry system is not made with natural rubber latex.
xiv 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
About this Manual
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© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 1
Chapter 1: Product Description
Product Denition
The Mini Telemetry System includes receiver and transmitter. It provides a wireless means of transmitting heart
rate and uterine activity signals from an ambulatory1 mother to a fetal or maternal/fetal monitor. The system
operates with the following Corometrics brand monitors:
• 120 Series
• 170 Series
• 250 Series
• 250cx Series
The transmitter is also sold separately, it is compatible with 340 telemetry receiver. All the connections remain
the same.
NOTE: The operator will identify fetal movements with the MARK button instead of the automatic fetal movement
detection support of the fetal monitor system. The system monitors fetal heart rate through ultrasound doppler
technology, ECG (FECG or MECG), and uterine activity (TOCO or IUPC) signals individually or in combination—
depending on the available parameter in the fetal or maternal/ fetal monitor. Refer to your monitor’s operation
manual as needed.
Indications for Use
The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory
mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows
ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination.
The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner
in a dened coverage area.
The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other
vehicles associated with health care facilities.
1 Walking/resting or on an emergency shifting process within hospitals.
2 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 1: Product Description
Product Features
The Mini Telemetry oers the following features:
• Battery operated transmitter which provides up to 12 hours2 of continuous transmission when charged for
a period of 4 hours.
• Low Battery indicator accompanied by an audio indicator which signals an impending low-battery condition.
• Transmitter headset which allows the patient or sta to hear the heartbeats detected ultrasonically for
reassurance as well as to verify proper transducer placement.
• Signal strength indicator that veries the strength of the radio transmission signal.
• Interchangeable Transducers: Transducers are quickly and easily interchangeable amongst the Mini
Telemetry System and Corometrics brand monitors. Following is the list of monitors:
• 120 Series: Transducers are interchangeable.3
• 170 Series: Transducers are interchangeable.
• 250 Series: Transducers are interchangeable.3
• 250cx Series: Transducers are interchangeable.3
• Simultaneous monitoring of two heart rates (twins) when used with a monitor supporting parameters:
Ultrasound FHR and FECG.
• Display to view the battery charge status, audio volume status and channel frequency.
• External power adaptor to charge the internal battery.
• Groove on the transmitter for cable management.
• In-built Mark key on the transmitter to transmit fetal movement information.
• Quick charge feature which provides up to 150 minutes of continuous transmission with just 30 minutes of
charging.
• Can be used during laboring in water/showers.4
2 Use of the headset and the speakers will deplete the battery charge more rapidly.
3 Round connector cables are compatible whereas ECG rectangular connector cables are not compatible.
4 Refer to Warnings, Cautions and Notes section.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 3
Chapter 2: Safety
The information presented in this section is important for the safety of both the patient and operator and also
serves to enhance equipment reliability. This chapter describes how the terms Danger, Warning, Caution,
Important and Note are used throughout the manual. In addition, standard equipment symbols are dened.
General Information
General Use
If any equipment is cold to the touch or below ambient temperature, allow it to stabilize to ambient temperature
before use.
To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems
Information Technologies. Parts and accessories used shall meet the requirements of IEC 60601-1.
Disposable devices are intended for single use only. They should not be reused.
Periodically and whenever the integrity of the equipment is in doubt, test all functions as indicated under the
section “Chapter 4: Installation and Setup” on page 19.
Refer to the “Maternal/Fetal Monitoring Operator’s Manual” for information concerning the limitations of internal
and external fetal heart rate monitoring techniques.
Responsibility of the Manufacturer
GE Medical Systems Information Technologies (hereafter Information Technologies) is responsible for the eects
on safety, reliability and performance if:
• Assembly operations, extensions, readjustments, modications, or repairs are carried out by persons
authorized by Information Technologies.
• The electrical installation of the relevant room complies with appropriate regulations.
• The equipment is used in accordance with the instructions for use.
4 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 2: Safety
Equipment Safety Information
The following table contains warnings for this manual. A Warning statement is used when the possibility of injury
to the patient or the operator exists.
WARNING
Do not place Mini-telemetry Transmitter on Receiver’s cavity while using Telemetry. There are
chances of faulty/erratic parametric readings being displayed on the monitor.
WARNING
Periodically check for ECG QRS complex trace if the monitor has an option for displaying waveform.
If random FHR / MHR / UA is observed on the strip chart paper /monitor display, please re-check the
transducer position. If the base line noise of ECG trace is observed to be high, there are chances of
faulty random FHR being displayed on the monitor.
WARNING
ACCIDENTAL SPILLS—In the event that uids are accidentally spilled on the equipment, take the
equipment out of operation and inspect for damage.
WARNING
CONDUCTIVE CONNECTIONS—Avoid making any conductive connections to applied parts (patient
connection) which are likely to degrade safety.
WARNING
CONDUCTIVE PARTS—Ensure that the conductive parts of the lead electrodes and associated
connectors do not contact other conductive parts including earth.
WARNING
DEFIBRILLATION—This equipment is not designed for use with debrillators.
WARNING
ELECTRICAL SHOCK—To reduce the risk of electrical shock, do not remove equipment covers.
Contact qualied personnel for servicing.
WARNING
ELECTROMAGNETIC INTERFERENCE—Be aware that strong electromagnetic elds may interfere
with equipment operation. Interference prevents the clear reception of signals by the device. If the
hospital is close to a strong transmitter such as TV, AM or FM radio, police or re stations, a HAM
radio operator, an airport, pager or cellular phone, their signals could be picked up as signals by the
equipment. If you feel interference is aecting the equipment, contact your Service Representative
to check the equipment in your environment.
WARNING
ELECTROSURGERY—The equipment is not designed for use with high-frequency surgical devices. In
addition, measurements may be aected in the presence of strong electromagnetic sources such
as electrosurgery equipment.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 5
Chapter 2: Safety
WARNING
EXPLOSION HAZARD—Do not use this equipment in the presence of ammable anesthetics or inside
an oxygen tent.
WARNING
FREQUENCY ALLOCATION- Frequencies of the receiver and transmitter have to be allocated. Refer to
Service Manual for the list of channel numbers.
WARNING
INSTRUCTIONS—For continued and safe use of this equipment, it is necessary to follow all listed
instructions. However, the instructions provided in this manual in no way supersede established
medical procedures concerning patient care. The device does not replace observation and
evaluation of the patient, at regular intervals, by a qualied care provider who will make diagnoses
and decide on treatments and interventions.
WARNING
INTERFACING OTHER EQUIPMENT—Monitoring equipment must be interfaced with other types
of medical equipment by qualied biomedical engineering personnel. Be certain to consult
manufacturers’ specications to maintain safe operation.
WARNING
BATTERY- Check battery low audio alarm and timely recharge the battery.
WARNING
ACCESSORY- Use GE recommended accessories/power adaptor as listed in the accessory list.
WARNING
RECEIVER PLACEMENT- Receiver has to be placed on at surface.
WARNING
TRANSDUCER CABLES- Remove transducer cables while transmitter is placed on the receiver.
WARNING
CLEANING AGENTS- Use recommended cleaning agents.
WARNING
MONITORING THROUGH CENTRAL NURSING STATION - Periodic monitoring of the mother has to be
done while monitoring through central nursing station.
WARNING
INTENDED USE- Intended use of telemetry is for ambulating mother.
WARNING
SPEAKER- Do not block speaker vents.
WARNING
LINE ISOLATION MONITOR TRANSIENTS—Line isolation monitor transients may resemble actual
cardiac waveforms and thus cause incorrect heart rate determination and alarm activation (or
inhibition).
6 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 2: Safety
WARNING
MRI USE—Do not use the equipment during MRI scanning, conducted current could potentially
cause burns.
WARNING
Do not charge transmitter during shower/laboring in water.
WARNING
SHOWER- Keep the transmitter away from water source.
WARNING
LEAKAGE CURRENT TEST—The interconnection of auxiliary equipment with this device may increase
the total leakage current. When interfacing with other equipment, a test for leakage current must
be performed by qualied biomedical engineering personnel before using with patients. Serious
injury or death could result if the leakage current exceeds applicable standards. The use of
accessory equipment not complying with the equivalent safety requirements of this equipment
may lead to a reduced level of safety of the resulting system. Consideration relating to the choice
shall include: use of the accessory in the patient vicinity and evidence that the safety certication
of the accessory has been performed in accordance with the appropriate IEC 60601-1 harmonized
national standard.
WARNING
PATIENT CABLES AND LEADWIRES—Do not use patient cables and electrode leads that permit direct
connection to electrical sources. Use only “safety” cables and lead wires . Use of non-safety patient
cables and lead wires creates risk of inappropriate electrical connection which may cause patient
shock or death.
WARNING
PACEMAKER PATIENTS—Rate meters may continue to count the pacemaker rate during occurrences
of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker
patients under close surveillance. Refer to your monitor’s operation manual for disclosure of the
pacemaker pulse rejection capability.
WARNING
SIMULTANEOUS DEVICES—Do not simultaneously connect more than one device that uses electrodes
to detect ECG and/or respiration to the same patient. Use of more than one device in this manner
may cause improper operation of one or more of the devices.
WARNING
STRANGULATION—Make sure all patient cables, leadwires and tubing are positioned away from the
patient’s head to minimize the risk of accidental strangulation.
WARNING
Not suggested to connect the transducer to mother while transmitter is placed on receiver/and
charging, as it may result in accidental drop of the transmitter from the receivers’ location
WARNING
LABORING IN WATER— Ensure that Mini Telemetry transmitter (excluding transducer) does not come
in direct contact with water. Failure to do so may result in electrical shock hazard.
WARNING
EQUIPMENT MODIFICATION: No modication of this equipment is allowed. Do not modify this
equipment without authorization of the manufacturer. If this equipment is modied, appropriate
inspection and testing must be conducted to ensure continued safe use of the equipment.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 7
Chapter 2: Safety
WARNING
RECEIVER CONNECTORS: Operator shall not touch the J1 and J2 connector at the back plate of the
Receiver and the patient simultaneously
WARNING
INTERFERENCE: The use of TENS (Transcutaneous Electrical Nerve Stimulation) used for pain relief
in labor can interfere with fetal/maternal monitoring with Coro monitors.
WARNING
APPLIED PARTS: Audio headset and the transducer cables can also come in contact with the patient
other than the labeled applied parts. These are classied as Type B.
WARNING
BATTERY: Only GE authorized / recommended battery pack shall be used to avoid wrong mounting
of battery, dangers related to polarity reversal, short circuit or ames.
The following table contains cautions for this manual. A Caution statement is used when the possibility of
damage to the equipment exists.
CAUTION
Mini Telemetry services shall be done only by authorized service personnel.
CAUTION
ANNUAL SERVICING—For continued safety and performance of the equipment, it is recommended
that the calibration, accuracy and electrical safety of the equipment be veried on an annual basis
by an Information Technologies Service Representative.
CAUTION
DAILY INSPECTION—It is essential that the equipment and accessories be inspected prior to every
use.
CAUTION
ENVIRONMENT—The performance of the equipment has not been tested in certain areas, such as
x-ray and imaging suites. The equipment is not recommended for use in these environments.
CAUTION
PERFORMANCE—Report all problems experienced with the equipment. If the equipment is not
working properly, contact your Service Representative for service. The equipment should not be
used if it is not working properly.
CAUTION
Check the health of the line voltage. Few hospital sites may nd noise in FECG/MECG when used
with power adaptor.
CAUTION
Periodic check needs to be done for mother’s parameter by the caregiver to ensure uninterrupted
monitoring.
CAUTION
Avoid over charging the battery or shorting the battery terminals.
CAUTION
STANDARD MAINTENANCE: Standard maintenance must be performed by authorized service
personnel for the lifetime of the product (7 years).
CAUTION
ULTRASOUND TRANSDUCER: Visually inspect the ultrasound transducer on a regular basis to ensure
there are no cracks or damages around the transducer face, cable, strain relief and connector pins.
8 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 2: Safety
FCC Information (USA)
FCC Rules Compliance
Telemetry FCC Rules Compliance
Mini Telemetry System FCC 47 CFR Part 95
This equipment complies with the FCC rules shown in above Table. Operation is subject to the condition that this
device does not cause harmful interference.
FCC RF Exposure Compliance
Important : RF EXPOSURE—To comply with FCC RF exposure compliance requirements, users should avoid
grasping the antenna for any extended period of time while the device is in operation.
FCC Service Information
Servicing the radio frequency transmitter and receiver sections of the Mini Telemetry System requires an FCC
General Radio Telephone License.
Any changes or modications made to the Mini Telemetry System that are not expressly approved by Information
Technologies, could void the user’s authority to operate this equipment.
Wireless Medical Telemetry Service (USA)
This section applies to Mini Telemetry Systems used in USA only.
IMPORTANT:
FREQUENCY COORDINATOR—Operation of a Mini Telemetry System requires prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
In June 2000, the FCC allocated new spectrum and established rules for Wireless Medical Telemetry Service
(WMTS) allowing potentially life-critical equipment to operate on an interference-protected basis.
The frequency allocation for WMTS provides spectrum where the equipment can operate on a primary basis
increasing the reliability of this important service. The FCC allocated 14 MHz of spectrum for use by medical
telemetry equipment in the 608–614 MHz, 1395–1400 MHz and 1429–1432 MHz bands. This allocation was
based on a needs assessment conducted by the American Hospital Association (AHA).
The 608–614 MHz band, which corresponds to TV channel 37 had been reserved for radio astronomy uses, so
this action elevates medical telemetry to a co-primary status with radio astronomy in this band. The 1395–1400
MHz and 1429–1432 MHz bands were government bands reallocated for non-government use.
WMTS is designated as one of the Citizen’s Band Services in Part 95 of the rules and licensed by rule to eliminate
the possible costs and delays to obtain individual operator’s licenses. The medical telemetry equipment is
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 9
Chapter 2: Safety
authorized under the certication procedure in Part 2 of the rules. One or more frequency coordinators maintain
a database of all equipment used in conjunction with WMTS.
For more information visit http://www.fcc.gov
Industry Canada Information
The Mini Telemetry System complies with Industry Canada RSS-210 .
Transmitter Antenna
The Mini Telemetry Transmitter has been designed to operate with an antenna having a maximum gain of 6 dBi.
Antenna having a higher gain is strictly prohibited as per regulations of Industry Canada. The required antenna
impedance is 50 Ω.
Interference
Mini-telemetry System operation is subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired operation of the
device.
Wireless Medical Telemetry Service
The Mini Telemetry System is only permitted for installation in hospitals and health care facilities. Devices shall
not be operated in mobile vehicles (even ambulances and other vehicles associated with health care facilities).
The installer/user of this device shall ensure that it is at least 80 km from the Penticton radio astronomy station
(British Columbia latitude: 49° 19’ 12” N: longitude: 118° 59’ 56” W). For medical telemetry systems not meeting
this 80 km separation (e.g. the Okinagan valley, British Columbia) the installer/user must coordinate with and
obtain the written concurrence of the Director of the Penticton radio astronomy station before the equipment
can be installed or operated. The Penticton contact is Tel: 250-493-2277/fax: 250-493-7767.
CE Marking Information Compliance
The Mini Telemetry System bears CE mark CE-0459 indicating conformity with the provisions of the Council
Directive 93/42/EEC concerning medical devices and fullls the essential requirements of Annex I of this directive.
The product is radio-interference protection class A in accordance with EN 55011
The country of manufacture can be found on the equipment labeling.
10 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 2: Safety
The product complies with the requirements of the standard EN 60601-1-2 “Medical Electrical Equipment - Part
1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirement and
tests.”
The safety and eectiveness of this device has been veried against previously distributed devices. Although all
standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic
compatibility standards),this device will not impair the safe and eective use of those previously distributed
devices.
R&TTE directive
The Mini Telemetry transmitter and receiver system conform to the R&TTE Directive 1999/5/EC.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 11
Chapter 3: Mini Telemetry Components
This section describes all controls, indicators and connectors on a Mini Telemetry System.
Transmitter
Oblique View
The following table describes the components of the Transmitter front panel:
Component Description
1. Display:
A display to show the charge status of battery, volume,
connectors connectivity, Channel number and mark
key.
2. Mark Key:
When the Mark key is pressed, one of the following
mark prints (depending on the type and/or setting of
the Corometrics monitor) on the strip chart paper of
Corometrics monitor:
• : The event marker is commonly used to
record an “event.” This mark is available on all
Corometrics brand monitors.
• : The fetal movement marker (default setting)
is commonly used as an indication that the
mother has perceived fetal movement. (Refer
to your monitor’s operator’s manual to learn if
your monitor supports this feature. Refer to your
monitor’s service manual for information about
enabling the option.)
The event marker is displayed on the transmitter
display as long as the Mark key is pressed.
NOTE: Mark key functionality will work only if atleast
one transducer is connected to the transmitter.
12 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 3:Mini Telemetry Components
Component Description
3. Volume Key:
If ultrasound transducer is connected, this key controls
the volume of fetal heartbeat, heard on the speaker/
headphone. Multiple presses of this key will cycle the
volume from mute to 5 volume levels.
4. Power Key:
Pressing the key once turns on the transmitter.
Pressing the key for more than 2 seconds turns o the
transmitter.
5. Ultrasound Input:
Connect a Corometrics 5700 Series pulsed Doppler
ultrasound transducer to this light grey receptacle.
6. ECG Input:
Connect an FECG cable/legplate or MECG cable plug
to this grey receptacle. This connector is compatible
with all round-connector FECG/MECG patient cables
used with Corometrics-brand monitors.
7. UA Input:
Connect a tocotransducer or IUPC transducer
connector to this white receptacle. Contact your Sales
Representative about compatibility.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 13
Chapter3 :Mini Telemetry Components
Side View
The following table describes the components of the Transmitter side panel:
Component Description
1. O ring:
Ring for attaching the carrying strap.
2. DC in-let Connector:
Connect the GE recommended power adaptor to this
connector for charging the transmitter battery.
WARNING:
Always use only GE recommended power adaptor.
3. Headset Connector:
Connect the headset to this receptacle to listen to the
fetal heart rate derived from ultrasound.
The transmitter has an option to wind transducer cables
on the enclosure as a part of cable management.
1. A groove provided on the sides of transmitter to
wind the long cables, especially used while mother
is ambulating.
14 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 3:Mini Telemetry Components
Battery Compartment
The following table describes the components of the Transmitter battery compartment:
Component Description
The battery compartment holds 1 Lithium ion battery.
Only authorized, trained personal shall open the
battery compartment for any service related actions.
CAUTION
BATTERY STRENGTH—The transmitter emits an audible
alarm when the transmitter battery is low. The onset
of audio alarm indicates that, unless the transmitter
battery is recharged, the transmitter will switch
o in approximately 5 minutes. If the transmitter
battery is not recharged, the alarm continues until the
transmitter switches o.
WARNING
Do not block the speaker vents.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 15
Chapter3 :Mini Telemetry Components
Display GUI
The following table describes the Transmitter display GUI:
Figure Description
1. Battery Charge Status:
Indicates battery level and charge status. Indications
continuously move while the battery is being charged.
2. Speaker Volume Status:
5 levels of volume and mute are indicated.
3. Mark Indicator:
Arrow mark is visible for an additional second after the
Mark key is released.
4. Channel Number:
Channel number of the transmitter is displayed. Refer
to the frequency chart in the service manual.
5. Transducer Connection Status:
Indicates the connection status of the parametric
connectors. Filled circle indicates connector plugged
in, empty circle indicates connector not plugged in.
Display Indications
The following table shows the transmitter display indications:
Indication Description
Indicates speaker is mute.
Indicates battery error.
Indicates radio module error.
16 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 3:Mini Telemetry Components
The transmitter unit generates three distinct audio alerts in case of low battery conditions. A short beep alarm
is generated when the battery charge goes below the low-charge limit. A long beep alarm is generated when
the battery charge level is critical and immediate recharging is required. The alarm will be generated at a faster
rate when the battery run-time left is about one minute until the battery is completely depleted and the unit
automatically turns o. Alarm tones will be deactivated when the Mini Telemetry transmitter is connected to the
external power adaptor for charging.
Receiver
Receiver Front Panel
The following table describes the components of the Receiver front panel:
Component Description
1. Signal Indicator
The green Signal indicator lights
continuously when the receiver is
accepting radio frequency signals from the
transmitter. The Signal indicator ashes if
the signal strength is weak or marginal.
2. UA Mode Selector :
This switch communicates the active
uterine activity mode to the fetal or
maternal/fetal monitor:
• When monitoring with a
tocotransducer, set the switch to
the TOCO position.
• When monitoring with an
intrauterine pressure catheter, set
the switch to the IUP position.
3. Low Battery Indicator
The red battery indicator shows that the
transmitter’s battery is low.
4. Power Switch
The Power switch turns the receiver on (I)
and o (O). When it is set to on, the green
Power indicator illuminates.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 17
Chapter3 :Mini Telemetry Components
Component Description
5. Channel Number:
The channel number is the customer-
designated frequency of the receiver.
For each telemetry system, the channel
number of the receiver must be identical
to the channel number of the transmitter.
Also, if you have more than one telemetry
system, or other RF devices, each system
must have a unique channel number.
Receiver Rear Panel
The following table describes the components of the Receiver rear panel:
Component Description
1. Equipotential Lug:
Binding post terminal, which is directly connected
to chassis, for use as an equipotentiality connector.
2. Transmitter Placeholder:
Placeholder provided for the transmitter.
3. Antenna Connector:
Twist-on connector for attaching the receiver
antenna.
4. AC Line Connector and Fuseholder Module:
This module houses the AC-line input connector
and the main fuses for the receiver:
• 100-120 VAC: requires two, 0.25 A slow-
blow fuses.
• 220-240 VAC: requires two, 0.25 A slow-
blow fuses.
18 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 3:Mini Telemetry Components
Component Description
5. Power cord holder clamp:
To hold the power cord.
6. Auxiliary Output Connector
This connector outputs the US, ECG, UA and Mark
signals acquired by telemetry to a compatible
fetal/fetal-maternal Monitor. See “Connecting the
Receiver and Monitor” on page 19 for complete
interconnection details.
As soon as any telemetry mode is detected, the
front panel of the compatible fetal/fetal-maternal
monitor is disabled and all front panel inputs are
ignored. In other words, telemetry and monitor
modes cannot be mixed and matched, you must
use either telemetry or direct monitoring only.
For proper operation with 120, 170, 250 or 250cx
Series monitors, disconnect all transducers from
the front panel of the monitor.
7. Programming Connector
The channel number of receiver can be changed
through the transmitter using programming
connector. For more details, refer to Appendix B.2
of Mini-telemetry service manual.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 19
Chapter 4: Installation and Setup
This section contains step-by-step instructions for connecting and testing your Mini Telemetry System.
IMPORTANT
CHANNEL NUMBERS—Ensure that the receiver and transmitter are operating on the same frequency, the channel
numbers must be identical. The channel number label is located on the top of the receiver and on the back panel
of the transmitter.
If you have more than one Telemetry system, make sure that each transmitter/receiver pair operates on a unique
frequency.
Connecting the Receiver and Monitor
There is a single way of interconnection method between Telemetry receiver and fetal or maternal/fetal monitor.
Check your monitor model number prior to making any connections.
Models 126, 128, 129, 171, 172, 173, 174, 256, 259, 256cx, 259cx
IMPORTANT: 120 SERIES COMMUNICATIONS OPTION — A 120 series monitor requires a communications Board
in order to interface to a Mini Telemetry system. If your monitor does not have this option, an upgrade kit is
available as cat. no. (REF) 1559BAO. Contact your service representative for more information.
Perform the following steps to connect the receiver and monitor:
Step Instructions
Instructions to position the Receiver:
1. Turn o both the monitor and the receiver.
2. Place the receiver on the cart, or on top of, or near,
the monitor.
Note: Model 250/250cx shown.
20 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Step Instructions
Instructions to attach the Receiver Antenna:
1. Insert the receiver antenna into the antenna
connector on the receiver rear panel as shown
in the gure. Rotate the attachment collar in a
clockwise direction until snug.
NOTE: A Remote Antenna Bracket, cat. no. (REF)
1441AAO, is available for attaching the antenna when
the receiver will be enclosed in a cart or cabinet. Refer
to the Installation Instructions, part no. (REF) 14153AA,
included with the bracket or contact your Biomedical
Engineering Department for assistance. To attach the
antenna to the BNC connector on the bracket, rotate
the antenna attachment collar in a clockwise direction
until snug.
Instructions to attach the Monitor Interconnect
Cable to a 120, 250 or 250cx Series Monitor:
1. Plug one end of the interconnection cable into the
Auxiliary Output connector on the receiver rear
panel.
2. Plug the other end into J101 telemetry connector
on the rear panel of the monitor.
Instructions to attach the Monitor Interconnect
Cable to a 170 Series Monitor:
1. Connect to the receptacle labeled
Note: Use 1563AAO interconnect cable.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 21
Chapter4: Installation and Setup
Setting up the Transmitter
Connecting Battery to Circuit Board
NOTE: The battery of Mini-telemetry transmitter is shipped without being connected to the circuit board.
Before using the telemetry transmitter, ensure that battery is connected to the circuit board.
SENSITIVE TO ELECTROSTATIC DISCHARGE CAUTION
This procedure involves handling of ESD sensitive parts. ESD control guidelines must be followed
during this procedure to ensure that static charges are safely conducted to the ground and not
through the sensitive device, to prevent damage to the equipment.
Step Instructions
Instructions to connect battery to circuit board:
1. Use a T10 Torx screwdriver to remove the battery
compartment screw and washer.
2. Slide the battery cover out.
22 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Step Instructions
3. Connect the battery to the Battery Connector on the
circuit board. Perform step 2 and 1 in reverse order to
complete the battery installation.
Connecting Power Adaptor
Perform the following steps to connect the power adaptor.
Step Instructions
Instructions to connect the power adaptor:
1. Turn o the transmitter.
2. Locate the DC inlet jack and connect the DC
adaptor and plug the adaptor to AC mains
socket.
3. Switch on the AC mains with specied AC voltage
indicated in the specications. Charge the internal
battery for 4hrs before using the Transmitter.
Check for battery charge/full indication on the
display.
IMPORTANT : Power Adaptor —Use only the appropriate
country specic plug attachments to the Adaptor. The
Mini Telemetry system’s Adaptor comes with global
plugin options.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 23
Chapter4: Installation and Setup
Replacing the Plug Attachments
Perform the following steps to replace the plug attachments.
Step Instructions
Instructions to replace the plug attachment:
1. Press and hold the Release button as shown
in gure 1 and rotate the plug attachment anti-
clockwise to release it from the adaptor.
2. Place the desired plug attachment on the adaptor.
Press and hold the Release button as shown in
gure 2 and rotate clockwise to attach the plug to
the adaptor.
Attaching the Carrying Strap
Perform the following steps to attach the carrying strap.
Step Instructions
Instructions to attach the carrying strap:
1. Secure the metal clips at each end of the carrying
strap to the belt attachment loops on each side of
the transmitter as shown in gures 1 and 2.
2. Adjust the strap length as per mother’s comfort
for easy carrying.
24 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Performing a Functional Checkout
Initial Conditions
Step Instructions
Connect the receiver to the monitor as described in
“Connecting the Receiver and Monitor” section earlier
in this chapter.
Turn on the transmitter, receiver and monitor attached
to the receiver.
Testing the Radio Frequency
Perform the following steps to test the radio frequency.
Step Instructions
Instructions to Test the Radio Frequency:
1. Check the status of the Signal indicator on
the receiver:
• Continuous Green: Indicates that the receiver
is accepting the radio frequency signals from
the transmitter and the signal strength is
good.
• Flashing Green: Indicates the signal strength
is weak or marginal.
2. Check the status of the Battery indicator on
the receiver:
• O : The transmitter battery is adequately
charged.
• Blinking/Continuous Red: The transmitter
battery is low and should be recharged before
further patient use.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 25
Chapter4: Installation and Setup
Testing the Ultrasound Functions
NOTE: TRANSDUCER TYPE—Use only Corometrics 5700 Series Ultrasound Transducers with the Mini Telemetry
System.
Perform the following steps to test the ultrasound functions:
Step Instructions
Instructions to Test Ultrasound Functions:
1. Plug an ultrasound transducer into the Ultrasound
connector on the transmitter as shown in the
gure.
2. Verify the following:
• Ultrasound transducer connector status
indication is reected on the transmitter
display.
• FHR value on the monitor shows “– – –”.
• Telemetry connected symbol will be printed on
the strip chart paper. Additionally, Telemetry
symbol will be displayed on Corometrics 120,
250 and 250cx series monitor.
If “_ _ _” is not displayed on the monitor, ensure that
the corresponding interconnection cable is rmly
attached to both the monitor and the receiver.
3. Use your nger to gently rub the ultrasound
transducer surface in a rhythmic manner to
simulate a FHR. Try to maintain a steady rate and
verify the following on the monitor: (Alternative
method – place the transducer in the palm of your
hand and rhythmically tap the top of your hand to
simulate heartbeat.)
• The corresponding FHR display value responds
to the rubbing.
• The corresponding FHR heartbeat indicator
responds to the input.
• The ultrasound audio tones are synchronous
with the transducer stroking.
26 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Step Instructions
4. Plug the headset into the transmitter’s headset
connector
5. Rub the face of the ultrasound transducer. Verify
that you hear ultrasound audio tones from both
sides of the headset or in the internal speakers (if
head set is not connected)
Testing the ECG Functions
Perform the following steps to test the ECG functions.
Step Instructions
Instructions to test the ECG functions:
1. Plug an ECG transducer into the ECG connector on
the transmitter as shown in the gure.
2. Verify the following on the monitor:
• ECG transducer connector status indication is
reected on the transmitter display.
• Telemetry connected symbol will be printed on
the strip chart paper. Additionally, Telemetry
symbol will be displayed on Corometrics 120,
250 and 250cx series monitor.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 27
Chapter4: Installation and Setup
Testing the UA Functions
Perform the following steps to test the UA functions.
Step Instructions
Instructions to test UA functions:
1. Place the receiver’s UA Mode Selector switch in
the TOCO position.
IMPORTANT :
TRIMLINE TOCOTRANSDUCERS—If the monitor is
on when you connect or re-connect a Trimline
Tocotransducer to the UA connector, you must wait
at least 10 seconds before pressing the UA Reference
button. If the monitor is o, you must wait at least 10
seconds from the time the monitor is powered on.
2. Plug a tocotransducer into the transmitter’s UA
connector as shown in the gure. Verify that,
• UA transducer connector status indication is
reected on the transmitter display.
• Telemetry connected symbol will be printed on
the strip chart paper. Additionally, Telemetry
symbol will be displayed on Corometrics 120,
250 and 250cx series monitor.
• An arbitrary pressure value is displayed on the
monitor.
IMPORTANT:
DEFAULT REFERENCE VALUE—Most monitors have
a default UA reference of 10 relative units. Take into
consideration that newer model monitor’s can be
congured to store a custom default value.
3. Press the monitor’s UA Reference button to set the
UA value to 10 relative units. Verify that Toco value
on the monitor display shows 10 relative units.
28 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Step Instructions
4. Apply gentle pressure to the tocotransducer
pressure sensing button and verify that the
monitor (display or uterine activity trace) responds
to the pressure input. Increasing force should
produce an increasing value and vice versa. If
no pressure changes are recorded, ensure that
the corresponding interconnection cable is rmly
attached to both the monitor and the receiver.
NOTE: Refer respective operator manual of the fetal
monitor.
5. This step applies to monitors which support IUP
monitoring. Place the receiver’s UA Mode Selector
switch in the IUP position. Verify the following on
the monitor:
• Corometrics 120, 250, 250cx series monitor :
“IUP” will be displayed on the monitor as the
UA mode.
• Corometrics 170 series monitor: Turn on the
strip chart recorder and check that the “IUP”
annotation is printed on the paper.
NOTE: Place the UA Mode Selector switch back in the
TOCO position unless you plan to monitor with an IUPC.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 29
Chapter4: Installation and Setup
Testing the Event Marker Function
Perform the following steps to test the event marker function.
Step Instructions
Instructions to test the event marker function:
1. Connect any transducer to the Mini-telemetry
transmitter. Turn on the monitor’s strip chart
recorder.
NOTE: Mark key functionality will work only if atleast
one transducer is connected to the transmitter.
2. Press the Mark key on the transmitter for at least
one second. Verify that an appropriate mark is
printed on the paper and appears on the
transmitter display.
NOTE: The settings for the mark should to be done in
the monitor.
• : This annotation is commonly used to
record an event. This mark is available on all
Corometrics-brand monitors.
• : This annotation is commonly used as an
indication that the mother has perceived fetal
movement. (Refer to the operator’s manual for
your monitor to learn if your monitor supports
this feature. Refer to the service manual of
your monitor for information about enabling
the option.)
Testing the Environment
Decide on which areas of your facility will be used for ambulatory monitoring. Test each location separately
to rule out rooms that are restricted due to solid concrete walls, metal structures blocking signal transmission.
Biomedical engineer or installation team will identify and manage distance measurements to ensure optimal
signal clarity.
30 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Monitoring via Telemetry
This section provides a brief overview of telemetry monitoring procedures. Refer to the “Maternal/Fetal
Monitoring Operator’s Manual” for patient application information. Also refer to your monitor’s operator manual.
Suggestions for Ambulatory Monitoring
IMPORTANT :
DESIGNATED AREAS—Show the patient the areas that are within signal range and where signal reception is
clear. The designated area is determined at the time of installation.
Following are the suggestions for ambulatory monitoring:
1. Instruct the patient to wear the transmitter with the enclosure faced towards the receiver when possible.
2. Adjust the carrying strap to a comfortable length.
3. Encourage the patient to walk in a smooth, gliding motion. It is preferable to slide feet instead of moving
quickly which may cause bouncing and artifact.
4. Instruct the patient, following each fetal movement, to listen via the headset or speaker, for continued
“pickup” of fetal heart rate tones.
NOTE: Transducers with short cables are available. Contact your Information Technologies Sales representative
Perform the following precautionary measures during ambulatory monitoring:
Illustration Description
1. Make sure the transducer cables are not hanging
loosely, the patient is in danger of tripping over
the cables.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 31
Chapter4: Installation and Setup
Illustration Description
2. Shorten the length of the transducer cables by
winding it around the transmitter as seen in the
gure to avoid tripping.
3. For additional transducer cable management
use the velcro strips provided to arrest the
transducer cables as shown in the gure.
Monitoring Reminders
General
• Use the correct interconnection method according to your monitor model. See page 19.
• Remember to apply power to all three devices: monitor, receiver and transmitter.
• Check that each interconnection cable is rmly attached to both the receiver and the monitor.
• As soon as any telemetry mode is detected, the front panel of the 250 or 170 Series Monitor is disabled
and all front panel inputs are ignored. In other words, telemetry and monitor modes cannot be “mixed and
matched”, you must use telemetry only or direct monitoring only.
IMPORTANT :
170 SERIES—For proper operation with a 170 Series Monitor, disconnect all transducers from the front panel of
the monitor.
32 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 4: Installation and Setup
Ultrasound
• Use only Corometrics 5700 Series ultrasound transducers with a Mini Telemetry System.
• Remind the patient to use the headset / speaker to check for continual pickup of the fetal heart rate signal
following each fetal movement.
FECG
• You may need to tape the transducer cable to the patient to prevent excessive tension on the legplate or
attachment pad.
• Though it is not suggested to use FECG during ambulation, the recommended position for the legplate is on
top of the upper thigh instead of the inner thigh. This facilitates walking and minimizes uid contacting the
legplate.
Tocotransducer
• Remember to place the receiver’s UA Mode Selector switch in the TOCO position.
• When connecting or re-connecting a Corometrics Trimline Tocotransducer to the transmitter’s UA connector,
you must wait at least 10 seconds before pressing the monitor’s UA Reference button. If any device (monitor,
receiver, transmitter) is o, you must wait at least ten seconds from the time the last device is powered on.
IUPC
• Remember to place the receiver’s UA Mode Selector switch in the IUP position.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 33
Chapter 5: Maintenance and Cleaning
Maintenance
This section describes general care and cleaning instructions for the Mini Telemetry System.
Storage
Place the transmitter on the placeholder of the receiver when it is not used.
NOTE: The transmitter can be charged when placed on the receiver.
CAUTION:
Do not connect the transducer cables to the transmitter when it is placed on the receiver, this may cause the
transmitter to fall o the receiver.
Use care while carrying the receiver and transmitter.
General Cleaning Precautions
NOTE: Refer to your monitor’s operator manual for cleaning instructions for the monitor and transducers.
CAUTION
SHOCK—Unplug the fetal or maternal/fetal monitor and the receiver from the AC power source and detach all
accessories. Do not immerse accessories in any liquid. Do not use abrasive cloth or cleaners on the monitor, the
receiver, the transmitter, or any accessories. Do not spray cleaning solutions into the vents.
Cleaning the Transmitter and Receiver
1. Wipe any uids from the surface of each unit.
2. Dampen a soft cloth with cleaning solution and gently rub soiled area until clean.
3. Dry with a soft, dry cloth.
34 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 5: Maintenance and Cleaning
The following table lists approved cleaning solutions.
Generic Formulation Maximum concentration level
Hydrogen peroxide 6 %
Sodium hypochlorite 100 parts per million (ppm)
CaviCide® 100 % spray (apply on equipment sprayed on cloth-
not directly on equipment.
Shoulder Strap Cleaning
1. Wipe any uids from the surface of the shoulder strap.
2. Dampen a soft cloth with cleaning solution and gently clean the strap.
3. Wipe with cotton cloth dipped in water to remove any traces of cleaning agent.
4. Dry with a soft, dry cloth.
The following table lists approved cleaning solutions.
Generic Formulation Maximum concentration level Expected life of the belt
Hydrogen peroxide 6 % Minimum 1000 cleanings
Sodium hypochlorite 100 parts per million (ppm) Minimum 1000 cleanings
CaviWipes™ Not applicable for CaviWipes™ Minimum 300 cleanings
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 35
Chapter 6: Troubleshooting
This section of the manual provides a troubleshooting guide for the Mini Telemetry System’s operational
problems. If the response to a specic question is not found, contact service department. Refer to contact
details mentioned in the back cover.
Problem Chart
Troubleshooting
Problem Probable Cause Solution
Receiver Power indicator
does not light when the
receiver is turned on.
• Receiver not connected to AC
receptacle.
• Connect to AC receptacle.
• Defective AC power cord. • Replace AC power cord.
• Use a dierent AC outlet.
Signal indicator
ashes with
transmitter turned
on.
• Transmitter antenna detached. • Contact your Service Representative.
(Reattach transmitter antenna as
instructed in Antenna Replacement
Chapter of Service Manual).
• Receiver antenna not attached. • Connect receiver antenna as instructed
in Chapter 4: Installation and Setup on
page 19.
• If problem persists, contact your
Information Technologies Service
Representative.
36 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 6: Troubleshooting
Troubleshooting
Problem Probable Cause Solution
Signal indicator
flashes
intermittently as
patient ambulates.
• Mom is ambulating at the edge
of transmitter range.
• Instruct patient to stay within signal
range and designated areas where
reception is clear.
• Reduced range due to shielding
eect of hospital infrastructure. • Install optional ceiling antenna system.
• Transmitter antenna detached. • Contact your Service Representative.
(Reattach transmitter antenna as
instructed in Antenna Replacement
Chapter of Service Manual)
• If problem persists, contact your
Information Technologies Service
Representative.
Signal and/
or Low Battery
indicators light
with transmitter
turned o.
• External source of radio
frequency interference is
present.
• Contact your Information Technologies
Service Representative.
• Another transmitter with the
same frequency is in use within
the same facility.
• Reprogram the transmitter and/or
receiver to a dierent frequency using
the procedure listed in “Appendix C”
after consultation with a frequency
coordinator designated by FCC.
• Service required. • Discontinue use of one of the
transmitters.
• If problem persists, contact your
Information Technologies Service
Representative.
Low Battery
indicator on the
receiver lights
continuously
and Low Battery
indicator is
displayed on the
transmitter screen
and audio alarm
can be heard
periodically.
Battery is low Recharge battery by connecting to the GE
recommended power adaptor.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 37
Chapter 6: Troubleshooting
Troubleshooting
Problem Probable Cause Solution
Erratic FHR/MHR/UA
reading.
• Transducer not properly
positioned on mother’s
abdomen.
• Reposition transducer.
• Transducer not properly
connected to transmitter.
• Ensure the transducer is securely
attached to the transmitter.
• In case of erratic UA reading,
check if TOCO/IUP switch
on the receiver matches the
UA transducer connected to
transmitter.
• Ensure TOCO/IUP switch on the receiver
matches the UA transducer connected
to transmitter.
• Receiver interconnection
cable(s) not properly attached.
• Ensure interconnection cable(s) is rmly
attached to both monitor and receiver.
• Receiver interconnection
cable(s) defective.
• Replace interconnection cable(s).
• Wrong interconnection cable(s)
in use.
• Verify interconnection method.
• Radio frequency interference. • Instruct patient to stay within signal
range and designated areas where
reception is clear.
• Another transmitter with the
same frequency is in use within
the same facility.
• Discontinue use of one of the
transmitters. NOTE: Mini Telemetry can
be re-programmed to an alternative
frequency.
• Exceeding transmission range. • Install optional ceiling antenna system.
• Shielding eect of hospital
structure. • If problem persists, contact your
Information Technologies Service
Representative.
• Transmitter front-end circuitry
not working.
• Faulty transducer. • Contact your Information technologies
service representative.
FHR/MHR or UA values
are not displayed on the
corometrics monitor when
transducers are plugged
into transmitter.
• Transmitter and/or receiver o. • Ensure all three devices are turned on.
• Receiver interconnection
cable(s) not properly attached.
• Ensure interconnection cable(s) rmly
attached to both monitor and receiver.
• Receiver interconnection
cable(s) defective.
• Replace interconnection cable(s).
• Wrong interconnection cable(s)
in use.
• Verify interconnection method.
• Faulty transducer. • Contact your Information Technologies
Service Representative.
38 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 6: Troubleshooting
Troubleshooting
Problem Probable Cause Solution
Noisy FHR/MHR waveforms
are displayed on the
corometrics monitor.
• Mom is ambulating at the edge
of the transmitter range.
• Instruct patient to stay within strong
signal range and designated areas
where reception is clear.
No data received in the
receiver even though both
receiver and transmitter are
ON
• Receiver interconnection
cable(s) not properly attached.
• Ensure interconnection cable(s) rmly
attached to both monitor and receiver.
• Receiver interconnection
cable(s) defective. • Replace interconnection cable(s).
• Wrong interconnection cable(s)
in use. • Verify interconnection method.
• Transmitter and receiver tuned
to dierent frequencies.
• Program the transmitter and/or receiver
to the required channel number using
the procedure listed in Appendix B of
Service Manual after consultation with
a frequency coordinator designated by
FCC.
• Transmitter antenna detached. • Contact your Service Representative.
(Reattach transmitter antenna as
instructed in Antenna Replacement
Chapter of Service Manual)
• If problem persists, contact your
Information Technologies Service
Representative.
Mini Telemetry transmitter
switches o automatically
• Battery is low. • Recharge battery by connecting to the
GE recommended power adaptor.
• Battery overheating • Contact your Information Technologies
Service Representative.
“E1” is displayed on the
transmitter screen on
startup
RAM error Contact your Information Technologies
Service Representative.
“E2” is displayed on the
transmitter screen on
startup
FLASH error Contact your Information Technologies
Service Representative.
Mini Telemetry transmitter
display is blank or shows
junk data
• Defective display
• Software issue Contact your Information Technologies
Service Representative.
No audio beep is heard
when EVENT or VOLUME key
on the transmitter is pressed
• Audio hardware failure
• Software issue Contact your Information Technologies
Service Representative.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 39
Chapter 6: Troubleshooting
Troubleshooting
Problem Probable Cause Solution
Radio channel number does
not appear in the normal
user screen on transmitter
display
• Currently congured radio
channel number is outside the
supported range as specied
in service manual.
• Communication between the
system and the radio module
is not established.
• Radio module is defective.
Contact your Information Technologies
Service Representative.
Bad Radio Icon
appears on the
transmitter screen
• Transmitter frequency is
outside the range of the radio
module.
• Communication between the
system and the radio module
is not established.
• Radio module is defective.
Contact your Information Technologies
Service Representative.
Bad battery icon
appears on the
transmitter screen
• Transmitter battery pack over
discharged
• Connect the power adaptor to the
transmitter and charge for 15 minutes.
Disconnect the power adaptor and
reconnect. Switch on the transmitter
and check if bad battery symbol is
replaced with the battery status.
• Disconnect the battery from the
battery compartment. Refer to section
6.1.1 of Mini-telemetry service manual
for battery replacement procedure.
Reconnect the battery and repeat the
previous step.
• Disconnect the battery from the
battery compartment. Refer to section
6.1.1 of Mini-telemetry service manual
for battery replacement procedure.
Using an external DC source (8.5V and
current limited to 1000mA), charge the
battery for 5 minutes. Reconnect the
battery and repeat the previous step.
• Defective battery
• Battery not able to charge • Contact your Information Technologies
Service Representative.
• Replace the battery
40 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Chapter 6: Troubleshooting
This page is left blank intentionally,
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 41
Appendix A
Appendix A: Supplies and Accessories
This section provides an overall listing of supplies and accessories for use with a Corometrics Mini Telemetry
System and with Corometrics Fetal or Maternal/Fetal Monitors. To order any of the supplies and accessories
listed in this manual, refer to the addresses listed in the back cover.
General Supplies
Item Catalog Number (REF)
TX Power Adaptor 2042491-001
TX Adaptor kit 2050315-001
Carrying strap 4426AAO
Transmitter to Receiver PROG Cable ASSY 2049878-001
Velcro strips 2051975-001
Base Plate for Mini Telemetry Wall Mount 2051641-001
Mini Telemetry Wall mount Assembly 2052779-001
Headset for Mini Telemetry System 3316AAO
System Interconnect Cable 1563AAO
RXR 425MHZ MINI ANTENNA 2052722-001
RXR 435 MHz MINI ANTENNA 2049802-001
RXR 445 MHz MINI ANTENNA 2049803-001
RXR 611 MHz MINI ANTENNA 2049804-001
Power cord -UK 2037674-001
Power cord- EU 2037672-001
Power cord- US 2037671-001
Power cord- ANZ 2037673-001
Power cord-Japan 405535-014
Power cord-Italian 2037677-001
Power cord- Swiss 401855-107
Power cord- Indian 2037676-001
Mini Telemetry Service manual-English 2049821-001
Mini Telemetry Operation manual-English 2049809-001
Mini Telemetry Operation manual-German 2049810-001
Mini Telemetry Operation manual-Dutch 2049811-001
Mini Telemetry Operation manual-Italian 2049812-001
42 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix A
General Supplies
Item Catalog Number (REF)
Mini Telemetry Operation manual-Spanish 2049813-001
Mini Telemetry Operation manual-Greek 2049814-001
Mini Telemetry Operation manual-Polish 2049815-001
Mini Telemetry Operation manual-Russian 2049816-001
Mini Telemetry Operation manual-Japan 2049817-001
Mini Telemetry Operation manual-Korean 2049818-001
Mini Telemetry Operation manual-Portuguese 2049819-001
Mini Telemetry Operation manual- French 2049820-001
Quick Ref Guide – English 2049966-001
Quick Ref Guide - German 2049967-001
Quick Ref Guide – Dutch 2049968-001
Quick Ref Guide – Italian 2049969-001
Quick Ref Guide - Spanish 2049970-001
Quick Ref Guide – Greek 2049971-001
Quick Ref Guide – Polish 2049972-001
Quick Ref Guide - Russian 2049973-001
Quick Ref Guide – Japan 2049974-001
Quick Ref Guide – Korean 2049975-001
Quick Ref Guide - Portuguese 2049976-001
Quick Ref Guide - French 2049977-001
Please refer to operator manuals of respective monitors for part numbers of the transducers.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 43
Appendix B: Technical Specications
NOTE: Specications are subject to change without notice.
This section contains a detailed list of the technical specications for the Mini Telemetry System.
B.1 Transmitter
Transmitter
Category Technical Specications
Power adaptor requirements
Input voltage range :
Line frequency
Power consumption (maximum)
During charging
Mains isolation
100-240VAC
50-60Hz
15W
4000VAC, 5656VDC
Primary-Secondary
Physical Characteristics
Height:
Width:
Depth:
Weight:
1.9” ( 4.7cm)
4.7” (11.9cm)
4.8” (12.1cm)
1lb (0.45kg)
Environmental Conditions
Ambient Temperature:
Relative Humidity:
Atmospheric Pressure:
Altitude:
Storage and Transport
14°F to 131°F (–10°C to 55°C)
5% to 95%, non-condensing
700–1060 mbar (525–795 mmHg)
Operating
50°F to 104°F (10°C to 40°C)
5% to 95%, non-condensing
700–1060 mbar (525–795 mmHg)
Up to 3000m
44 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix B
Transmitter
Category Technical Specications
Certication and Compliance
UL:
FCC:
Industry Canada:
EN:
UL 60601-1
United States FCC 47 CFR Part 95
Canadian RSS-210
European EN 300-220-1
Monitoring Modes
Fetal Heart Rate:
Uterine Activity:
Maternal Heart Rate:
Ultrasound (US) and FECG
External Tocotransducer (TOCO) or Internal Intrauterine Pressure
Catheter (IUPC)
Maternal ECG (MECG)
Ultrasound Mode
Technique: Pulsed Doppler with autocorrelation processing
Transducer Type: 9-crystal
Leakage Current: < 100 µA, isolated by transducer (TYPE BF)
I(sata) at the transducer face 2.7 mW/cm2*
Entrance beam dimensions (Aaprt)10.18 cm2
Center frequency (fc)1.151 MHz ± 40 Hz
Pulse duration 92.5 µs
Pulse repetition frequency 2 kHz ± 8 Hz
Global maximum value of total
acoustic power (W0)
27.5 mW*
Spatial-average pulse-average
intensity
14.6 mW/cm2 < 20 mW/cm2 ( FDA limit)
Measurement uncertainties
- I(sata) ± 7%
- Ultrasonic power (W0)± 7%
- Center frequency (fc)± 5%
*These parameters calculated as X + Ks where X is the mean value of the measurement, s = the standard deviation of the
measured values, and K = 4.258 (K chosen for 90% condence for 90% of the population for a sample size of 3).
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 45
Appendix B
Transmitter
Category Technical Specications
ECG Mode
Input Impedance:
DC Tolerance:
Common Mode Rejection Ratio:
FECG Sensitivity:
MECG Sensitivity:
Leakage Current:
>1 GΩ
±1 V
>90 dB
30 µ V to 1 mV
0.5 mV to 5 mV
< 10 µA (TYPE CF)
TOCO Mode
Type:
Sensitivity:
Range:
Tocotransducer
20 µ V/relative unit
0 to +100 relative units
IUPC Mode
Type:
Sensitivity
Range:
Leakage Current:
DC Strain Gauge
20 µ V/mmHg
0 to +100 mmHg
< 10 µA (TYPE CF)
Antenna Type: Internal , helical
Control:
Power Key
Mark key
Speaker volume key (internal speaker and head set)
46 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix B
Transmitter
Category Technical Specications
Battery
Technology:
Capacity:
Recharge time:
Backup:
Quick charge:
Li-Ion battery pack (2 cells) 7.2 VDC nominal
2600mAh
4 hours
Approximately 12 hours when fully charged
2.5 hours backup when recharged for 30 min
Audio Indicator: Low Battery
Audio output:
Internal speaker
Audio head set
Alarms
Audio alarm for every 1.6s if battery is LOW
Audio alarm for every 0.8s if battery is critical.
Display
132x32 resolutions in pixels.
Pixel 0.35x0.40mm
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 47
Appendix B
Transmitter
Category Technical Specications
RF Section
Power Output:
Channel Bandwidth:
Transmission Range:
Frequency Band : Power Output
420.0500 - 429.7375 MHz: 1mW
432.0000 - 438.0000 MHz: 4mW
440.5625 - 449.6625 MHz: 1mW
608.0250 - 613.9750 MHz: 4mW
Frequency Band : Channel Bandwidth
420.0500 - 429.7375 MHz : 12.5kHz
432.0000 - 438.0000 MHz : 25kHz
440.5625 - 449.6625 MHz : 12.5kHz
608.0250 - 613.9750 MHz : 25kHz
Frequency Band : Distance Coverage
420.0500 - 429.7375 MHz : 100m
432.0000 - 438.0000 MHz : 500m
440.5625 - 449.6625 MHz : 100m
608.0250 - 613.9750 MHz : 500m
Connectors:
DC inlet for charger
Audio head set
3 parametric connector ( US-FHR, UA, MECG/FECG )
Classication Class IIb device under Rule 10 of Annex IX of the Council Directive 93/42/
EEC
(Line of Sight*)
* Un-obstructed path between transmitter and receiver antenna. Actual range may vary depending on the hospital infrastructure.
48 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix B
B.2 Receiver
Receiver
Category Technical Specications
Power Requirements
Nominal Line Voltage:
Line Frequency:
Power Consumption (maximum):
Touch current:
100-120VAC 220-240VAC
Fuse 0.25A T Fuse 0.25A T
50/60Hz
30 W
<300µA
Physical Characteristics
Height:
Width:
Depth:
Weight:
4” (10.2cm)
8.1” (20.6cm)
11.9” ( 30.2cm)
5.6 lbs (2.55kg)
Environmental Conditions
Ambient Temperature:
Relative Humidity:
Atmospheric Pressure:
Altitude:
Storage and Transport
14°F to 131°F (–10°C to 55°C)
5% to 95%, non-condensing
700–1060 mbar (525–795
mmHg)
Operating
50°F to 104°F (10°C to 40°C)
5% to 95%, non-condensing
700–1060 mbar (525–795 mmHg)
Up to 3000m
Certication and Compliance
UL:
FCC:
Industry Canada:
EN:
UL 60601-1
United States FCC 47 CFR part 95
Canadian RSS-210
European EN 300-220-1
Output Signals: US, FECG, MECG, TOCO, IUPC and Mark
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 49
Appendix B
Receiver
Category Technical Specications
RF Section
Input Impedance:
Input Sensitivity:
50 Ω
<0.4 µ V for 12 dB SINAD
Antenna Type: Flexible, detachable, BNC interconnect
(Other factory-approved external antennas or antenna systems
may be used. Contact your Information Technologies Service
Representative for more information.)
Controls: Power Switch, UA Mode Switch
Visual Indicators:
Power:
Signal Strength:
Transmitter Low/Depleted Battery:
Green LED
Green LED
Red LED
Connectors:
AC Line Input:
Auxiliary Output:
3-Prong, IEC-Style
Use only with Series 250 and 170 Monitors.
Classication Class IIb device under Rule 10 of Annex IX of the Council Directive
93/42/EEC
Product Compatibility
The system operates with the following Corometrics brand monitors. If your monitor is not listed, check with your
salesperson or service representative for a more current list.
• 120 Series
• 170 Series
• 250 Series
• 250cx Series
50 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix B
This page is left blank intentionally.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 51
Appendix C: Electromagnetic Compatibility
C.1 Electromagnetic compatibility (EMC) guidance
Safety Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-2-49
EMC Standards: IEC 60601-1-2
WARNING:
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided below.
WARNING:
Portable and mobile RF communication equipment can aect Medical Electrical Equipment.
Caution should be use when operating such devices around Medical Electrical Equipment
WARNING:
This equipment/system is intended for use by healthcare professionals only. This equipment system
may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary
to take mitigation measures, such as re-orienting or relocating the equipment/system or shielding the
location.
C.2 Manufacturer’s guidance and declaration regarding electromagnetic
immunity
The unit is intended for use in the electronic environment specied below. The user of the unit should ensure that
it is used in such an environment.
Electromagnetic immunity
Immunity Test IEC 60601 Test Level Compliance level Electromagnetic environment
guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic
material the relative humidity should be at
least 30%.
52 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix C
Electromagnetic immunity
Immunity Test IEC 60601 Test Level Compliance level Electromagnetic environment
guidance
Electrical fast
transient/burst IEC
61000-4-4
± 2kV for power supply
line.
± 1kV for input/output
line.
± 2kV for power supply
line.
± 1kV for input/output
line.
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1kV dierential Mode.
± 2kV common mode
line.
± 1kV dierential Mode.
± 2kV common mode
line.
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
<5 % Ut(>95 % dip in Ut)
for 0.5 cycle
40 %Ut (60 % dip in Ut)
for 5 cycles
70 % Ut(30 % dip in Ut)
for 25 cycles
<5% Ut(>95% dip in Ut)
for 5 sec.
<5 % Ut(>95 % dip in Ut)
for 0.5 cycle
40 %Ut(60 % dip in Ut)
for 5 cycles
70 % Ut (30 % dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the unit requires continued
operation during power mains interruptions,
it is recommended that the unit be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic eld
environment
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should be
at levels characteristic of a typical location in
a typical commercial or hospital.
NOTE: Ut is the main voltage before application of the test level.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 53
Appendix C
International Electrotechnical Commission (IEC) guidance and manufacturer’s declaration regarding
electronic immunity
The unit is intended for use in the electronic environment specied below. The user of the unit should ensure that
it is used in such an environment.
Electromagnetic immunity
Immunity
Test
IEC 60601
Test Level
Compliance
level Electromagnetic environment guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the unit, including cables, than the
recommended separation distance calculated from the equation
applicable for the frequency of the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 KHz to 80
MHz
3V
Recommended separation distance
P2.1d =
Radiated RF can aect the accuracy of in-bed-scale readings.
However, the in-bed-scale is not critical to the performance of the
unit (see Note 1, below).
P2.1d =
= 26 MHz to 800 MHz
P2.1d =
= 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths for xed RF transmitters as determined by an
electromagnetic site survey (see Note a) should be less than
the compliance level in each frequency range (see Note b on the
following page).
Interference may occur in the vicinity of equipment. Marked with the
following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 6
GHz
3 V/m
IEC 60601-2-37
3 V/m
80 MHz to 6
GHz
3V/m
NOTE 1: Portable and mobile equipment can aect medical electronic equipment.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption
and reection from structures, objects and people.
NOTE a: Field strengths from xed transmitters such as base stations for radio, cellular/cordless telephones
and land mobile radios, amateur radios, AM and FM radio broadcasts and TV broadcasts cannot be predicted
54 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix C
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
unit is used exceeds the applicable RF compliance level above, the unit should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the unit.
NOTE b: Over the frequency range 150 KHz to 80 MHz eld strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the
Mini Telemetry
The unit is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the unit can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communica tions equipment (transmitters) and the unit as
recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
(W)
Separation distance in meters (m) according to frequency of transmitter
150 kHz to 80 MHz
P2.1d =
80 MHz to 800 MHz
P2.1d =
800 MHz to 2.5 GHz
P2.1d =
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1.0 1.2 1.2 2.3
10.0 3.8 3.8 7.3
100.0 12.0 12.0 23.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d)
in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption
and reection from structures, objects and people.
© 2010 by General Electric Company. All rights reserved. 2049809-001 Rev B 55
Appendix D: Warranty
This Product is sold by GE Healthcare under the warranties set forth in the following paragraphs.
Such warranties are extended only with respect to the purchase of this Product directly from GE Healthcare or GE
Healthcare’s Authorized Dealers as new merchandise and are extended to the Buyer thereof, other than for the
purpose of resale. For a period of twelve (12) months for the product from the date of original delivery to Buyer
or to Buyer’s order, but in no event for a period of more than two years from the date of original delivery by GE
Healthcare to an GE Healthcare Authorized Dealer, this Product, other than its expendable parts, is warranted to
be free from functional defects in materials and workmanship and to conform to the description of the Product
contained in this operation manual and accompanying labels and/or inserts, provided that the same is properly
operated under the conditions of normal use, that regular periodic maintenance and service is performed and
that replacements and repairs are made in accordance with the instructions provided. This same warranty is
made for a period of thirty (30) days with respect to expendable parts such as batteries.
The foregoing warranties shall not apply if the Product has been repaired other than by GE Healthcare or in
accordance with written instructions provided by GE Healthcare, or altered by anyone other than GE Healthcare,
or if the Product has been subject to abuse, misuse, negligence, or accident. GE Healthcare’s sole and exclusive
obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing,
free of charge, at GE Healthcare’s option, a Product, which is telephonically reported to the nearest GE Healthcare
Regional Service Oce and which, if so advised by GE Healthcare, is thereafter returned with a statement of the
observed deciency, not later than seven (7) days after the expiration date of the applicable warranty, to the
designated GE Healthcare Service Center during normal business hours, transportation charges prepaid and
which, upon GE Healthcare’s examination, is found not to conform with above warranties.
GE Healthcare shall not be otherwise liable for any damages including but not limited to incidental damages,
consequential damages, or special damages. There are no express or implied warranties that extend beyond the
warranties hereinabove set forth. GE Healthcare makes no warranty of merchantability or tness for a particular
purpose with respect to the product or parts thereof.
56 2049809-001 Rev B © 2010 by General Electric Company. All rights reserved.
Appendix D
This page is left blank intentionally.
E CR E P
EC Representative
GE Medical Systems
Information Technologies GmbH
Munzingerstrasse 5
79111 Freiburg
Germany
Tel: +49 761 45 43 -0
Fax:+49 761 45 43 -233
Asia Representative
GE Medical Systems
Information Technologies Asia
GE (China) Co., Ltd
No. 1 Huatuo Road
Zhangjiang Hi-Tech Park Pudong
Shanghai, People’s Republic of China 201203
Tel: +86 21 5257 4650
Fax: +86 21 5208 2008
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue Milwaukee, WI 53223 USA
Tel: + 1 414 355 50001 800 558 5120 (US Only)
Fax:+ 1 414 355 3790
Made in India
www.gehealthcare.com

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