Mortara X12 Plus User Manual

REF 9515-164-50-ENG Rev D1

X12+

AMBULATORY TRANSMITTER

USER MANUAL

Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Copyright © 2015

by Mortara Instrument, Inc.

7865 N. 86th Street

Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. X12+ is a
trademark of Mortara Instrument, Inc.

TECHNICAL SUPPORT AND SERVICE

Headquarters

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www.mortara.com

European Union
Representative

Mortara Instrument Europe, s.r.l.

(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italy
Tel: [phone]
Fax: [phone]

Service/Technical
Support Group

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
Fax: [phone]
E-mail: [e-mail]

Sales Support/
Supplies & Accessories

Mortara Instrument, Inc.

7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Fax: [phone]

Hospital Customers: [e-mail]
Physician Practice: [e-mail]
U.S. Distribution: [e-mail]

Mortara Instrument Germany

Bonifaciusring 15
45309 Essen
Germany
Tel: [phone]
Fax: [phone]

Mortara Instrument Netherlands

Postbus 324
5680 AH Best
Industrieweg 160b
5683 CG Best
Netherlands
Tel: [phone]
Fax: [phone]

Mortara Instrument Australia

PO Box 7568
Baulkham Hills NSW 2153
Unit 28, 9 Hoyle Avenue
Castle Hill NSW 2154
Australia
Tel: [phone]
Fax: [phone]

Mortara Dolby UK Ltd.

Units 11 & 12, Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Scotland
Tel: [phone]
Fax: [phone]

i

NOTICES

Manufacturer’s Responsibility

Mortara Instrument, Inc. is responsible for the effects on safety and performance only if:

• Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons
authorized by Mortara Instrument, Inc.

• The device is used in accordance with the instructions for use.

Responsibility of the Customer

The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
Failure to do so may cause undue failure and possible health hazards.

Equipment Identification

Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device. Care
should be taken so that these numbers are not defaced.

Copyright and Trademark Notices

This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated to another language without prior written consent of
Mortara Instrument, Inc.

Other Important Information

The information in this document is subject to change without notice.

Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited to,
implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes no
responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes no
commitment to update or to keep current the information contained in this document.

ii

WARRANTY INFORMATION

Your Mortara Warranty

MORTARA INSTRUMENT, INC. (hereafter referred to as “Mortara”) warrants that components within Mortara
products (hereafter referred to as “Product/s”) will be free from defects in workmanship and materials for the
number of years specified on documentation accompanying the product, or previously agreed to by the purchaser
and Mortara, or if not otherwise noted, for a period of twelve (12) months from the date of shipment.

Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are warranted
to be free from defects in workmanship and materials for a period of 90 days from the date of shipment or the date
of first use, whichever is sooner.

Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD PRESSURE
HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES, MAGNETIC STORAGE
MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects in workmanship and materials for
a period of 90 days. This warranty does not apply to damage to the Product/s caused by any or all of the following
circumstances or conditions:

a) Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information

guides;

d) Accident; a disaster affecting the Product/s;
e) Alterations and/or modifications to the Product/s not authorized by Mortara;
f) Other events outside of Mortara’s reasonable control or not arising under normal operating conditions.

THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT
CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY
MORTARA TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by Mortara
of any alleged defects promptly after discovery thereof within the warranty period. Mortara’s obligations under the
foregoing warranty will further be conditioned upon the assumption by the purchaser of the Product/s (i) of all
carrier charges with respect to any Product/s returned to Mortara’s principal place or any other place as specifically
designated by Mortara or an authorized distributor or representative of Mortara, and (ii) all risk of loss in transit. It
is expressly agreed that the liability of Mortara is limited and that Mortara does not function as an insurer. A
purchaser of a Product/s, by its acceptance and purchase thereof, acknowledges and agrees that Mortara is not liable
for loss, harm, or damage due directly or indirectly to an occurrence or consequence therefrom relating to the
Product/s. If Mortara should be found liable to anyone under any theory (except the expressed warranty set forth
herein) for loss, harm, or damage, the liability of Mo rtara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.

iii

WARRANTY INFORMATION

EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST MORTARA FOR CLAIMS RELATING TO THE
PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE SHALL BE
THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT THE DEFECT IS
NOTICED AND MORTARA IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN NO EVENT,
INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL MORTARA BE LIABLE FOR INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR EXPENSE OF
ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE OR STRICT
LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN LIEU OF ANY
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED
WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE.

iv

USER SAFETY INFORMATION

Warning:

Caution:

Note:

Warning(s)

 This manual gives important information about the use and safety of this device. Deviating from operating

procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.

 Device transmits data reflecting a patient’s physiological condition to a properly equipped receiving device that

when reviewed by a trained physician or clinician, can be useful in determining a diagnosis; however, the data
should not be used as a sole means for determining a patient’s diagnosis.

 Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient

care, and adequately trained in the use of this device. Before attempting to use th is device for clinical
application, the operator must read and understand the contents of the user manual and other accompanying
documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and
bystanders, or damage to the device. Contact Mortara service for additional training options.

 To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in

direct patient contact must be in compliance with UL 60601-1, IEC 60601-1 and IEC 60601-2-25. Only use
parts and accessories supplied with the device and available through Mortara Instrument, Inc.

 Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for

defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.

 Conductive parts of the patient cable, electrodes, and associated connections of type CF applied parts, including

the neutral conductor of the patient cable and electrodes, should not come into contact with other conductive
parts including earth ground.

 ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.

 To avoid the possibility of serious injury or death during patient defibrillation, do no t co me into co ntact with

device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.

 Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of this device

may alter defibrillator protection.

 This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be

employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
other adverse reactions.

Means there is the possibility of personal injury to you or others.

Means there is the possibility of damage to the device.
Provides information to further assist in the use of the device.

v

USER SAFETY INFORMATION

 To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must

not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.

 FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for

compliance could void the user’s authority to operate the device.

 A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
 The device has not been designed for use with high-frequency (HF) surgical equipment and does not provide a

protective means against hazards to the patient.

 The quality of the signal produced by the device may be adversely affected by the use of other medical

equipment, including but not limited to defibrillators and ultrasound machines.

 There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used

simultaneously with the device; however, disturbance to the signal may occur.

 Operations may be affected in the presence of strong electromagnetic sources such as electrosurgery equipment.
 The battery operated device transmits data reflecting a patient’s physiological condition to a receiving device.

During operation failure, data transmission and LCD information will cease to occur. In mission critical
conditions, it is advisable to have a backup device available.

 There is a potential pinch hazard when applying the battery compartment cover to the device that could result in

minor injury. Care should be taken to avoid entrapment of fingers when performing this operation.

 The device is restricted to use on one patient at a time.
 The performance of the device may be compromised by excessive motion.
 Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.

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USER SAFETY INFORMATION

Caution(s)

 To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use fingertips.

 Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning

as this may damage equipment or reduce its usable life. Use of unspecified cleaning/disinfecting agents, failure
to follow recommended procedures, or contact with unspecified materials could result in increased risk of harm
to users, patients and bystanders, or damage to the device. Do not sterilize the device or patient cables with
Ethylene Oxide (EtO) gas.

 The device and patient cable should be cleaned between each use. Inspect cable and connections for damage or

excessive wear prior to each use. Replace cable if damage or excessive wear is noted.

 Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patien t cab les

should be stored after forming them into a loose loop.

 The device will only work with receiving devices that are equipped with the appropriate option.
 No user-serviceable parts are inside. Damaged or suspected inoperative equipment must be immediately

removed from use and must be checked/repaired by qualified service personnel prior to continued use.

 This device is not recommended for use in the presence of imaging equipment such as Magnetic Resonance

Imaging (MRI) and Computed Tomography (CT) devices, etc.

 The following equipment may cause interference with the RF channel: microwave ovens, diathermy units with

LANs (spread spectrum), amateur radios, and government radar.

 When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),

and/or packing materials in accordance with local regulations.

 Wipe the exterior surface of the device and patient cables with a sterilizing disinfectant and then dry with a

clean cloth.

 AA batteries are known to leak their contents when stored in unused equipment. Remove battery from device

when not used for an extended period of time.

 To prevent possible damage to the device during transport and storage (while in original packaging) the

following environmental conditions must be adhered to:

Ambient Temperature Range: -20°C to 65°C (-4°F to 149°F)
Relative Humidity Range: 5% to 95% (non-condensing)
Atmosphere Pressure: 700 hPa to 1060 hPa

 Allow the device to stabilize within its intended operating environment for a minimum of two hours prior to

use. The allowable operating environment is as follows:

Ambient Temperature Range: 0°C to 45°C (32°F to 113°F)
Relative Humidity Range: 5% to 95% (non-condensing)
Atmosphere Pressure: 700 hPa to 1060 hPa

vii

USER SAFETY INFORMATION

FCC Compliance Statement

In the United States use of this device is regulated by the Federal Communications Commission (FCC). The device
with its antenna complies with FCC’s RF exposure limits for general population/uncontrolled exposure.

FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the device.

X12+ (600) FCC ID: HJR-X12-600-15
X12+ (2500) FCC ID: HJR-X12P-2500
X12+ (915) FCC ID: HJR-X12P-915

These devices comply with Part 15 of the FCC rules. Operation is subject to the followin g conditions:

1. This device may not cause harmful interference, and

2. This device must accept any interference received, including interference that may cause undesired operation.

 The X12+ (600) must be used solely on the premises of healthcare facilities (see Part 15, section 15.242a).
 A healthcare facility operating the X12+ (600) must coordinate with the directors of existing nearby TV

stations and radio astronomy observatories to ensure compatible use. Minimum separation distances from such
facilities may apply. It may be necessary to obtain written authorization from such facilities prior to installation
and use of the X12+ (Part 15, section 15.242d,e).

Industry Canada Compliance Statement

These devices comply with RSS-210 of the Industry Canada rules. Operation is subject to the following two
conditions:

1. This device may not cause interference, and

2. This device must accept any interference, including interference that may cause undesired operation of the

device.

X12+ (915) IC: 3758-X12P915
The term "IC:" before the certification/registration number only signifies that the Industry Canada technical

specifications were met.

X12+ (600) Certification Number: 3758A - 104616
This telemetry device is only permitted for installation in hospitals and healthcare facilities. Devices shall not be

operated in mobile vehicles (even
installer/user of this
Columbia latitude: 49° 19' 12" N, longitude: 118° 59' 56" W). For medical telemetry systems
80 km separation (e.g., the Okinagan valley, British Columbia), the installer/user
the written concurrence of the Director of the Penticton radio
installed or operated. The Penticton contact is Tel: [phone]/Fax: [phone].

device shall ensure that it is at least 80 km from the Penticton radio astronomy station (British

ambulances and other vehicles associated with healthcare facilities). The

not meeting this

must coordinate with and obtain

astronomy station before the equipment can be

viii

USER SAFETY INFORMATION

Note(s)

 Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
 If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is damaged,

display will indicate a lead fault for the lead(s) where the condition is present.

 For additional instructions and warnings, refer to the user manual of the receiving monitoring device.
 As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:

- Class I equipment or internally powered

- Type CF defibrillation-proof applied parts

- Ordinary equipment

- Equipment not suitable for use in the presence of a flammable anesthetic mixture

- Continuous operation

 Th e device will automatically turn off (blank screen) if the batteries have been severely discharged.
 The device is UL classified:

Medical Equipment

WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND MECHANICAL HAZARDS
ONLY, IN ACCORDANCE WITH UL 60601-1, CAN/CSA C22.2 No. 601.1,
IEC60601-1 AND IEC60601-2-25.

ix

USER SAFETY INFORMATION

x

EQUIPMENT SYMBOLS AND MARKINGS

Symbol Delineation

Attention, consult accompanying documents

Defibrillator-proof, Type CF input

Battery

Indicates compliance to applicable European Union directives

Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements

xi

GENERAL CARE

Precautions

 Turn off the device before inspecting or cleaning.
 Do not immerse the device in water.
 Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage

equipment surfaces.

Inspection

Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an authorized
service person to make the repairs.

 Verify that all cables and connectors are securely seated.
 Check the case for any visible damage.
 Inspect cables and connectors for any visible damage.
 Inspect buttons and controls for proper function and appearance.

Cleaning and Disinfection

Refer to section 3 for proper cleaning and disinfection procedures.

Sterilization

EtO sterilization is not recommended but may be required for cables and lead wires. Frequent sterilization will
reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a maximum
temperature of 50°C/122°F. After EtO sterilization, follow the recommendations from the sterilizer manufacturer
for required aeration.

Cautions

Improper cleaning products and processes can damage the device, produce brittle lead wires and cables, corrode the
metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining the device.

xii