GE Healthcare MINITEL2010 User Manual

Download

Page 1

GE Healthcare

Mini Telemetry

Operation and Maintenance Manual

Page 2

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.

Page 3

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

Page 4

Table of Contents

Chapter 4: Installation and Setup ................................................................................ 19

Display Indications .......................................................................................................................................... 15

Receiver ......................................................................................................................................................................... 16

Receiver Front Panel ....................................................................................................................................... 16

Receiver Rear Panel ........................................................................................................................................ 17

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

Page 5

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

Page 6

Table of Contents

This page is left blank intentionally.

Page 7

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.

Page 8

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

Page 9

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

About this Manual

E C R E P

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

Page 10

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.

POWER OFF: disconnection from the mains.

POWER 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

Page 11

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).

About this Manual

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).

Page 12

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.

Page 13

Pressure limitations in which the transport package has to be kept and handled.

NOTE: Mini-telemetry system is not made with natural rubber latex.

About this Manual

Page 14

About this Manual

This page is left blank intentionally,

Page 15

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.

Page 16

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.

• 170 Series: Transducers are interchangeable.

• 250 Series: Transducers are interchangeable.

• 250cx Series: Transducers are interchangeable.

• 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.

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.

Page 17

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.

Page 18

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.

Page 19

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).

Page 20

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.

Page 21

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.

Page 22

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

Page 23

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.

Page 24

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.

Page 25

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.

Page 26

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.

Page 27

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.

Page 28

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.

Page 29

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.

Chapter3 :Mini Telemetry Components

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.

Page 30

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.

Page 31

Chapter3 :Mini Telemetry Components

Component Description

5. Channel Number:

The channel number is the customerdesignated 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.

Page 32

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.

Page 33

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.

Page 34

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.

Page 35

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.

Page 36

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.

Page 37

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.

Chapter4: Installation and Setup

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.

Page 38

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.

Page 39

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.

Page 40

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.

Page 41

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,

Chapter4: Installation and Setup

• 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.

Page 42

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.

Page 43

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.

Chapter4: Installation and Setup

• : 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.

Page 44

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.

Page 45

Illustration Description

2. Shorten the length of the transducer cables by winding it around the transmitter as seen in the

gure to avoid tripping.

Chapter4: Installation and Setup

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.

Page 46

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.

Page 47

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.

Page 48

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 clothnot 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

Page 49

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.

• Defective AC power cord.

• Connect to AC receptacle.

• Replace AC power cord.

• Use a dierent AC outlet.

• Transmitter antenna detached. • Contact your Service Representative.

Signal indicator

ashes with

transmitter turned on.

• Receiver antenna not attached. • Connect receiver antenna as instructed

(Reattach transmitter antenna as instructed in Antenna Replacement Chapter of Service Manual).

in Chapter 4: Installation and Setup on page 19.

• If problem persists, contact your Information Technologies Service Representative.

Page 50

Chapter 6: Troubleshooting

Troubleshooting

Problem Probable Cause Solution

• Mom is ambulating at the edge

• Reduced range due to shielding

Signal indicator

• Transmitter antenna detached. • Contact your Service Representative. flashes intermittently as patient ambulates.

of transmitter range.

eect of hospital infrastructure.

• Instruct patient to stay within signal

range and designated areas where reception is clear.

• Install optional ceiling antenna system.

(Reattach transmitter antenna as instructed in Antenna Replacement Chapter of Service Manual)

• If problem persists, contact your Information Technologies Service Representative.

• External source of radio frequency interference is present.

Signal and/ or Low Battery indicators light

• Another transmitter with the same frequency is in use within the same facility.

with transmitter

turned o.

• Service required.

Low Battery indicator on the receiver lights continuously and Low Battery indicator is

Battery is low displayed on the transmitter screen and audio alarm can be heard periodically.

• Contact your Information Technologies Service Representative.

• 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.

• Discontinue use of one of the transmitters.

• If problem persists, contact your Information Technologies Service Representative.

Recharge battery by connecting to the GE recommended power adaptor.

Page 51

Troubleshooting

Problem Probable Cause Solution

• Transducer not properly

• Reposition transducer.

positioned on mother’s abdomen.

• Transducer not properly connected to transmitter.

• In case of erratic UA reading, check if TOCO/IUP switch on the receiver matches the

• Ensure the transducer is securely attached to the transmitter.

• Ensure TOCO/IUP switch on the receiver matches the UA transducer connected to transmitter.

UA transducer connected to transmitter.

• Receiver interconnection cable(s) not properly attached.

• Ensure interconnection cable(s) is rmly

attached to both monitor and receiver.

Chapter 6: Troubleshooting

• Receiver interconnection

Erratic FHR/MHR/UA reading.

cable(s) defective.

• Wrong interconnection cable(s) in use.

• Radio frequency interference. • Instruct patient to stay within signal

• Another transmitter with the

same frequency is in use within the same facility.

• Exceeding transmission range. • Install optional ceiling antenna system.

• Shielding eect of hospital

structure.

• Transmitter front-end circuitry not working.

• Faulty transducer. • Contact your Information technologies

• Transmitter and/or receiver o. • Ensure all three devices are turned on.

• Receiver interconnection

FHR/MHR or UA values are not displayed on the corometrics monitor when transducers are plugged into transmitter.

cable(s) not properly attached.

• Receiver interconnection cable(s) defective.

• Wrong interconnection cable(s) in use.

• Faulty transducer. • Contact your Information Technologies

• Replace interconnection cable(s).

• Verify interconnection method.

range and designated areas where reception is clear.

• Discontinue use of one of the transmitters. NOTE: Mini Telemetry can

be re-programmed to an alternative frequency.

• If problem persists, contact your Information Technologies Service Representative.

service representative.

• Ensure interconnection cable(s) rmly

attached to both monitor and receiver.

• Replace interconnection cable(s).

• Verify interconnection method.

Service Representative.

Page 52

Chapter 6: Troubleshooting

Troubleshooting

Problem Probable Cause Solution

Noisy FHR/MHR waveforms are displayed on the corometrics monitor.

• Mom is ambulating at the edge

• Instruct patient to stay within strong

of the transmitter range.

• Receiver interconnection

• Ensure interconnection cable(s) rmly

cable(s) not properly attached.

• Receiver interconnection cable(s) defective.

• Wrong interconnection cable(s) in use.

• Replace interconnection cable(s).

• Verify interconnection method.

signal range and designated areas where reception is clear.

attached to both monitor and receiver.

• Program the transmitter and/or receiver

No data received in the receiver even though both receiver and transmitter are ON

• Transmitter and receiver tuned to dierent frequencies.

• Transmitter antenna detached.

to the required channel number using the procedure listed in Appendix B of Service Manual after consultation with a frequency coordinator designated by FCC.

• 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.

• Battery is low. • Recharge battery by connecting to the

Mini Telemetry transmitter

switches o automatically

• Battery overheating • Contact your Information Technologies

“E1” is displayed on the transmitter screen on

RAM error

startup “E2” is displayed on the

transmitter screen on

FLASH error

startup Mini Telemetry transmitter

display is blank or shows

• Defective display

• Software issue

junk data No audio beep is heard

when EVENT or VOLUME key

• Audio hardware failure

• Software issue

on the transmitter is pressed

GE recommended power adaptor.

Service Representative.

Contact your Information Technologies Service Representative.

Page 53

Troubleshooting

Problem Probable Cause Solution

• Currently congured radio

channel number is outside the

Radio channel number does not appear in the normal user screen on transmitter display

supported range as specied

in service manual.

• Communication between the system and the radio module is not established.

Contact your Information Technologies Service Representative.

• Radio module is defective.

• Transmitter frequency is

Bad Radio Icon appears on the transmitter screen

outside the range of the radio module.

• Communication between the system and the radio module

Contact your Information Technologies Service Representative.

is not established.

• Radio module is defective.

Chapter 6: Troubleshooting

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

Page 54

Chapter 6: Troubleshooting

This page is left blank intentionally,

Page 55

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

Page 56

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.

Page 57

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

Physical Characteristics

Height:

Width:

Depth:

Weight:

Environmental Conditions

Ambient Temperature:

100-240VAC

50-60Hz

15W

4000VAC, 5656VDC Primary-Secondary

1.9” ( 4.7cm)

4.7” (11.9cm)

4.8” (12.1cm)

1lb (0.45kg)

Storage and Transport

14°F to 131°F (–10°C to 55°C)

Operating

50°F to 104°F (10°C to 40°C)

Relative Humidity:

Atmospheric Pressure:

Altitude:

5% to 95%, non-condensing

700–1060 mbar (525–795 mmHg)

5% to 95%, non-condensing

700–1060 mbar (525–795 mmHg)

Up to 3000m

Page 58

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:

Ultrasound (US) and FECG

External Tocotransducer (TOCO) or Internal Intrauterine Pressure Catheter (IUPC)

Maternal Heart Rate:

Maternal ECG (MECG)

Ultrasound Mode

Technique: Pulsed Doppler with autocorrelation processing

Transducer Type: 9-crystal

Leakage Current: < 100 µA, isolated by transducer (TYPE BF)

at the transducer face

(sata)

Entrance beam dimensions (A

Center frequency (fc)

aprt

2.7 mW/cm2*

10.18 cm2

)

1.151 MHz ± 40 Hz

Pulse duration 92.5 µs

Pulse repetition frequency 2 kHz ± 8 Hz

Global maximum value of total

27.5 mW*

acoustic power (W0)

Spatial-average pulse-average

14.6 mW/cm2 < 20 mW/cm2 ( FDA limit)

intensity

Measurement uncertainties

- I

(sata)

- Ultrasonic power (W0)

- Center frequency (fc)

*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).

± 7%

± 5%

Page 59

Transmitter Category Technical Specications ECG Mode

Appendix B

Input Impedance:

DC Tolerance:

Common Mode Rejection Ratio:

FECG Sensitivity:

MECG Sensitivity:

Leakage Current:

TOCO Mode

Type:

Sensitivity:

Range:

IUPC Mode

Type:

>1 GΩ

±1 V

>90 dB

30 µ V to 1 mV

0.5 mV to 5 mV

< 10 µA (TYPE CF)

Tocotransducer

20 µ V/relative unit

0 to +100 relative units

DC Strain Gauge

Sensitivity

Range:

Leakage Current:

20 µ V/mmHg

0 to +100 mmHg

< 10 µA (TYPE CF)

Antenna Type: Internal , helical

Power Key

Control:

Mark key

Speaker volume key (internal speaker and head set)

Page 60

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

Internal speaker

Audio output:

Audio head set Audio alarm for every 1.6s if battery is LOW

Alarms

Audio alarm for every 0.8s if battery is critical. 132x32 resolutions in pixels.

Display

Pixel 0.35x0.40mm

Page 61

Transmitter Category Technical Specications RF Section

Appendix B

Power Output:

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

Channel Bandwidth:

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

(Line of Sight*)

Transmission Range:

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

DC inlet for charger

Connectors:

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

* Un-obstructed path between transmitter and receiver antenna. Actual range may vary depending on the hospital infrastructure.

Page 62

Appendix B

B.2 Receiver

Receiver Category Technical Specications Power Requirements

Nominal Line Voltage:

Line Frequency:

Power Consumption (maximum):

Touch current:

Physical Characteristics

Height:

Width:

Depth:

Weight:

Environmental Conditions

Ambient Temperature:

100-120VAC 220-240VAC

Fuse 0.25A T Fuse 0.25A T

50/60Hz

30 W

<300µA

4” (10.2cm)

8.1” (20.6cm)

11.9” ( 30.2cm)

5.6 lbs (2.55kg)

Storage and Transport

14°F to 131°F (–10°C to 55°C)

Operating

50°F to 104°F (10°C to 40°C)

Relative Humidity:

Atmospheric Pressure:

Altitude:

Certication and Compliance

UL:

FCC:

Industry Canada:

EN: Output Signals: US, FECG, MECG, TOCO, IUPC and Mark

5% to 95%, non-condensing

700–1060 mbar (525–795 mmHg)

UL 60601-1

United States FCC 47 CFR part 95

Canadian RSS-210

European EN 300-220-1

5% to 95%, non-condensing

700–1060 mbar (525–795 mmHg)

Up to 3000m

Page 63

Receiver Category Technical Specications RF Section

Appendix B

Input Impedance:

Input Sensitivity: Antenna Type: Flexible, detachable, BNC interconnect

Controls: Power Switch, UA Mode Switch

Visual Indicators:

Power:

Signal Strength:

Transmitter Low/Depleted Battery:

Connectors:

AC Line Input:

Auxiliary Output: Classication Class IIb device under Rule 10 of Annex IX of the Council Directive

50 Ω

<0.4 µ V for 12 dB SINAD

(Other factory-approved external antennas or antenna systems may be used. Contact your Information Technologies Service Representative for more information.)

Green LED

Red LED

3-Prong, IEC-Style

Use only with Series 250 and 170 Monitors.

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

Page 64

Appendix B

This page is left blank intentionally.

Page 65

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

Electrostatic discharge (ESD) IEC 61000-4-2

± 6kV contact ± 8kV air

Electromagnetic environment guidance

Floors should be wood, concrete or ceramic

tile. If oors are covered with synthetic

material the relative humidity should be at least 30%.

Page 66

Appendix C

Electromagnetic immunity

Immunity Test IEC 60601 Test Level Compliance level

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz)

magnetic eld

environment IEC 61000-4-8

± 2kV for power supply line. ± 1kV for input/output line.

± 1kV dierential Mode. ± 2kV common mode line.

<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.

3 A/m 3 A/m

± 2kV for power supply line. ± 1kV for input/output line.

± 1kV dierential Mode. ± 2kV common mode line.

<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.

Electromagnetic environment guidance

Mains power quality should be that of a typical commercial or hospital environment.

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 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.

Page 67

Appendix C

P2.1d =

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

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601-2-37

IEC 60601 Test Level

3 V

rms

150 KHz to 80 MHz

3 V/m 80 MHz to 6 GHz

Compliance level

3 V/m

3V/m

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.

Recommended separation distance

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).

= 26 MHz to 800 MHz

= 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:

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

Page 68

Appendix C

P2.1d =

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

Separation distance in meters (m) according to frequency of transmitter

maximum output power

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

of transmitter (W)

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.

Page 69

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.

Page 70

Appendix D

This page is left blank intentionally.

Page 71

E C R 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

GE Healthcare MINITEL2010 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

User Responsibility

Conventions

Chapter 1: Product Description

Indications for Use

Product Features

Chapter 2: Safety

General Information

General Use

Responsibility of the Manufacturer

Equipment Safety Information

FCC Information (USA)

FCC Rules Compliance

FCC RF Exposure Compliance

FCC Service Information

Wireless Medical Telemetry Service (USA)

Industry Canada Information

Transmitter Antenna

Interference

Wireless Medical Telemetry Service

CE Marking Information Compliance

R&TTE directive

Chapter 3: Mini Telemetry Components

Transmitter

Oblique View

Side View

Battery Compartment

Display GUI

Display Indications

Receiver

Receiver Front Panel

Receiver Rear Panel

Chapter 4: Installation and Setup

Connecting the Receiver and Monitor

Setting up the Transmitter

Connecting Battery to Circuit Board

Connecting Power Adaptor

Replacing the Plug Attachments

Attaching the Carrying Strap

Performing a Functional Checkout

Initial Conditions

Testing the Radio Frequency

Testing the Ultrasound Functions

Testing the ECG Functions

Testing the UA Functions

Testing the Event Marker Function

Testing the Environment

Monitoring via Telemetry

Suggestions for Ambulatory Monitoring

Monitoring Reminders

General

Ultrasound

FECG

Tocotransducer

IUPC

Chapter 5: Maintenance and Cleaning

Maintenance

Storage

General Cleaning Precautions

Cleaning the Transmitter and Receiver

Shoulder Strap Cleaning

Chapter 6: Troubleshooting

Problem Chart

Appendix A: Supplies and Accessories

B.1 Transmitter

B.2 Receiver

Appendix C: Electromagnetic Compatibility

C.1 Electromagnetic compatibility (EMC) guidance

C.2 Manufacturer’s guidance and declaration regarding electromagnetic immunity

Appendix D: Warranty