Mortara Ambulo 2400 User manual

REF 9516-182-50-ENG Rev C1
AMBULO 2400
AMULATORY BLOOD PRESSURE MONITOR
SERVICEMANUAL
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 © 2018
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. E-Scribe, ELI,
and VERITAS are trademarks of Mortara Instrument, Inc. Cisco® is the registered trademark of Cisco Systems,
Inc. DICOM® is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information.

TECHNICAL SUPPORT AND SERVICE
1
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
Via Cimarosa, 103/105
40033 Casalecchio di Reno (Bologna)
Italia
Tel: [phone]
Fax: [phone]
E-mail: clienti.mortarait @ welchallyn.com
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) (USA)
Fax: [phone]
E-mail: [e-mail]
24-hour Technical Support
Same-day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Hospital Customers: [e-mail]
Physician Practice:[e-mail]
U.S. Distribution: [e-mail]
Mortara Instrument Germany
Hofgartenstraße 16
72379 Hechingen
Deutschland
Tel.: [phone]
Fax: [phone]
E-Mail: info @ welchallyn.com
Mortara Instrument Netherlands
“Amerika” Gebouw– 7e verdieping
Hoogoorddreef 15
1101 BA Amsterdam
Nederland
Tel.: [phone]
E-mail: infonl @ welchallyn.com
Mortara Instrument Australia
Head Office
Suite 4.01, 2-4 Lyonpark Road
Macquarie Park, Sydney
NSW 2113 Australia
Tel: [phone]
Fax: [phone]
Mortara Instrument UK
Clinitron House, Excelsior Road
Ashby de la Zouch
Leicester LE65 1JG
Tel: [phone]
Fax: [phone]

NOTICES
2
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.

WARRANTY INFORMATION
3
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 twenty-four (24) 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 there from 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 Mortara shall be limited to the lesser of the actual loss, harm, or
damage, or the original purchase price of the Product/s when sold.

WARRANTY INFORMATION
4
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.

USER SAFETY INFORMATION
5
Warning: Means there is the possibility of personal injury to you or others.
Caution: Means there is the possibility of damage to the device.
Note: Provides information to further assist in the use of the device.
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 captures and presents data reflecting a patient’s physiological condition 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 this device for clinical
applications, 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 Technical Service for additional training options.
● To avoid the potential for spread of disease or infection, blood pressure cuffs should be cleaned after each
patient use.
• This device is intended for use with ambulatory patients. This device is not intended for use with unconscious
or sedated patients.
• Warning: During device configuration using the HDS (Hypertension Diagnostic Suite) Software if a “Top
Inflation Pressure” above 300mmHg is entered the system will automatically enter the value of 300mmHg.
Further, if a “Top Inflation Pressure” above 285mmHg is entered and sent to an AMBULO 2400 device the
HDS software returned an error message. If the AMBULO 2400 device is then disconnected from the system
running the HDS software, the device displays an error “SE 18” indicating “Data memory area is unexpectedly
erased” and the “Top Inflation Pressure” defaults to 180mmHg automatically.
• Use only approved blood pressure (BP) cuffs specifically intended for use with the Ambulo 2400.
• Do not fold, clamp, cut, or alter the pressure hose of the cuff or the monitor.
• Instruct the patients to check the limb connected to the cuff for adequate perfusion, circulation, and function.
Repeated NIBP measurements can lead to hematomas, limb ischemia, and other limb injuries. Kinked or
blocked hoses can lead to prolonged impairment of blood circulation and lead to injury.
• Educate the patient to relax, rest, and lie still during inflation and pressure measurements. Patient movement can
lead to artifacts or errors.

USER SAFETY INFORMATION
6
• The pressure measurement might be influenced by patient position, physical conditions, and other factors.
• Avoid placing the blood pressure cuff on the arm next to where a patient has had a mastectomy.
• Avoid applying the cuff to a wounded limb as this can cause further injury. Use with caution in patients with
dermatological disease, subcutaneous laceration, or other integumentary compromise as there may exist a skin
damage hazard during electronic NIBP measurements. Follow prudent evidence-based clinical practice to
determine if an electronic blood pressure is safe for these patients.
• There may be an increased risk of hematomas in patients with serious coagulation problems.
• Avoid applying the cuff to a limb with a catheter, arterio-venous shunt or infusion pump applied. The cuff
pressure could produce damage to the tissues surrounding the catheter, shunt or the infusion needle, or
compromise the infusion flow.
• NIBP measurements may be inaccurate or be adversely affected in the presence of arrhythmias, arterial
sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, motion artifacts, shivering, or
trembling patients.
• NIBP cuffs and hoses supplied with the Ambulo 2400 do NOT contain any Latex. If the patient develops an
allergic reaction or rashes, immediately remove the cuff.
• Inflation of the NIBP cuff can cause a temporary degradation of monitoring of other parameters derived from
the same limb, including invasive pressure and SpO2 measurements. If applicable, place the SpO2 sensor and
the NIBP cuff on different limbs.
• The Ambulo 2400 should not be used for measurement of blood pressure in neonate patients.
Caution(s)
• Do not attempt to clean the device, patient cuffs or tubing by submersing into a liquid, autoclaving, or steam
cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm water
and mild detergent solution and then dry with a clean cloth. 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.
• No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
• No calibration or special equipments are needed for the proper operation or maintenance of the device.
●When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.
• Do not connect the device to any unauthorized devices or use any third-party accessories. This may cause
inaccurate measurements or harm the patient.

7
USER SAFETY INFORMATION
• Do not operate the device in conjunction with or in close proximity to other devices such as high frequency
surgical instruments, defibrillators, imaging systems, or other diagnostic or therapeutic devices. Simultaneous
operation may damage the device or lead to erroneous results.
• It is recommended to keep proper functioning backup items such as a spare patient cuff, extension hose,
interface cable, batteries and other equipment on hand to prevent delayed treatment due to an inoperable
device.
• While the Hypertension Diagnostics Suite software can operate in a multi-user networked-environment and
support hundreds of patient records, its performance may degrade with increasing database file size. In such
situations or perhaps on a regular basis, it is recommended that patient records be archived and a new patient
database be created. Refer to the Software Operation section of this User Manual for further information on
how to archive existing and create new databases.
Note(s)
• 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.
• As defined by IEC 60601-1, the device is classified as follows:
• Class I equipment or internally powered.
• Type BF and defibrillation-proof applied part.
• Ordinary equipment.
• Equipment not suitable for use in the presence of flammable or explosive environments including
anesthetic mixtures.
• Continuous operation.
• This device is intended to be used in an ambulatory setting as prescribed by a licensed physician, and should be
used and stored according to the environmental conditions specified below:
Operating temperature: +5° to +40°C (+41° to +104°F)
Operating humidity: 30% to 95% RH, non-condensing
Atmospheric pressure: 1033 hPa to 550 hPa
Storage temperature: -20° to +55°C (-4° to +131°F)
Storage humidity: 15% to 95% RH, non-condensing
Atmospheric pressure: 1059 hPa to 550 hPa
CAUTION: The device may not provide accurate results or may be damaged if operated or stored
beyond the specifications.
• The device is CSA classified:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 No. 601.1, IEC 60601-1-1, CAN/CSA C22.2 No.
60601-1-1-02, IEC60601-2-30 AND CAN/CSA C22.2 No. 601.2.30-99

8
EQUIPMENT SYMBOLS AND MARKINGS
Symbol Delineation
IPX1
Attention, consult accompanying documents.
Indicates device has been tested for safety from vertically dripping water;
specifically, it indicates DRIP PROOF, a higher than ordinary level of
protection from drips, leaks, and spills.
Defibrillator-proof type BF applied part.
Tested for safety by the Canadian Standards Association according to
applicable U.S. and Canadian standards and requirements.
Do not dispose as unsorted municipal waste. Per European Union
Directive 2002/96, requires separate handling for waste disposal according
to national requirements.
Indicates compliance to applicable European Union directives.
Consult accompanying documents

9
ELECTROMAGNETIC COMPATIBILITY (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device according to the international standard for EMC for medical
devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be used adjacent
to or stacked on top of other equipment, verify that the device operates in an acceptable manner in the configuration
in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical
equipment. See the appropriate table for recommended separation distances between the radio equipment and the
device.
Operation of the equipment beyond its specified ranges, or beyond normal physiological conditions of human
subjects, may cause inaccurate results.
The use of accessories, transducers, and cables other than those specified by Mortara Instrument may result in
increased emissions or decreased immunity of the equipment.
The essential performances of the Ambulo 2400 are:
Measurement Ranges
Systolic: 60 to 280 mmHg
Diastolic: 40 to 160 mmHg
Pulse Rate: 30 to 180 bpm
Measurement Accuracy
Blood pressure: ±3 mmHg mean difference ±8 mmHg standard deviation
Pulse rate: ±3 bpm
According to ANSI/AAMI SP-10 & BHS (Grade A/A) and ANSI/AAMI/ISO 81060-2
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions CISPR 11 Group 1 The equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause
any interference in nearby electronic equipment.
RF Emissions CISPR 11 Class B The equipment is suitable for use in all establishments, including
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic Emissions
IEC 61000-3-2 Not Applicable
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Not Applicable

ELECTROMAGNETIC COMPATIBILITY (EMC)
10
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Compliance Level Electromagnetic Environment: Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air +/- 6 kV contact +/- 8 kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
Not Applicable Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5 +/- 1 kV differential
mode
+/- 2 kV common
mode
Not Applicable Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips,
short
interruptions,
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Not Applicable Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the equipment requires continued
operation during power mains interruptions, it
is recommended that the equipment be
powered from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.

ELECTROMAGNETIC COMPATIBILITY (EMC)
11
)
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test IEC 60601 Test
Level Compliance Level
Electromagnetic Environment: Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d =1.17 P
d =1.17 P 80 MHz to 800 MHz
d = 2.34 P 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 from fixed RF transmitters, as
determined by an electromagnetic site surveya, should
be less than the compliance level in each frequency
rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

ELECTROMAGNETIC COMPATIBILITY (EMC)
12
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the Equipment
The equipment is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
equipment as recommended in the table below, according to the maximum output power of the communications
equipment.
Rated Maximum Output
Power
of Transmitter W
Separation Distance According to Frequency of Transmitter (m)
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d =1.17 P d =1.17 P
d = 2.34 P
0.01 0.12 m 0.12 m 0.23m
0.1 0.37 m 0.37 m 0.74m
1 1.17 m 1.17 m 2.33m
10 3.69 m 3.69 m 7.38m
100 11.67 m 11.67 m 23.33m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated 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 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by the
absorption and reflection from structures, objects, and people.
NOTE 3: If the equipment exceeds the applicable RF compliance level above, the equipment should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the equipment.

13
TABLE OF CONTENTS
GENERAL INFORMATION
Notices...........................................................................................................................................................................2
Warranty Information....................................................................................................................................................3
User Safety Information ................................................................................................................................................5
Equipment Symbols and Markings................................................................................................................................8
Electromagnetic Compatibility (EMC)..........................................................................................................................9
DEVICE CONFIGURATION
Configuration Commands ...........................................................................................................................................15
Summary of Configuration .........................................................................................................................................15
Configuration Settings ................................................................................................................................................15
MAINTENANCE, CALIBRATION & TESTING
Device Cleaning & Disinfecting .................................................................................................................................16
Maintenance and Calibration Procedure .....................................................................................................................18
Calibration & Test Record ..........................................................................................................................................25
CONFORMANCE TESTING
Conformance Testing .................................................................................................................................................26
Conformance Test Data Record ..................................................................................................................................38
UNIT DISASSEMBLY
Ambulo 2400 Unit Disassembly .................................................................................................................................40
Ambulo 2400 Item Identification Table ......................................................................................................................43
Sub-Assembly BOM Listing ......................................................................................................................................45
Screw Identification Table. .........................................................................................................................................45
DEVICE SPECIFICATIONS
Ambulo 2400 Specifications .......................................................................................................................................46
TROUBLESHOOTING
System Troubleshooting Chart ...................................................................................................................................47
DEVICE PROGRAMMING
Main Processor Programming ....................................................................................................................................48
Safety Processor Programming ...................................................................................................................................50

14
TABLE OF CONTENTS

15
DEVICE CONFIGURATION
Configuration Commands
The configuration pages define all operational conditions that do not change on a daily or patient-to-patient basis.
The device configuration settings are entered by Mortara Instrument at the time of device manufacture and
are not intended to be changed by the user. Configuration settings should only be changed by authorized Mortara
service personnel if a new main circuit board is being installed during service operations.
Summary of Configuration
Communication port will need to be verified through device manager, as this is needed for all CCT commands.
COM5 is used below as an example. For CCT installation and setup information, see the “Maintenance, Calibration
and Testing” section of this manual.
cct.py –s com5 –d
Device Configuration
Enter the following as prompted:
-Manufacturing Lot – Enter current manufacturing lot, Enter ‘6’
-Hardware Version – Enter current hardware version, Enter '1’
-S/N of the device – 5 digit number as read from the back label of the device
(may also be scanned off the barcode and must not be larger than 65565)
-Manufacturer Code (Location) – Enter “3” for Milwaukee
- Device ID – Enter ‘1’ for 010-2400-01 model number ; enter ‘2’ for 010-2400-02.
Configuration Settings
Software Version
Software Version
Identifies the version of the Hypertension Diagnostics Suite software. In the
Hypertension Diagnostics Suite software, click the “Help” menu at the top, then
“About Hypertension Diagnostics Suite Software”. Version will be displayed, for
example “Version 2.50”
Device Firmware Version
Identifies the firmware version of an Ambulo 2400 device. Install batteries in
the Ambulo 2400 device, as device powers up, it will display the 3 digit
firmware version. For example, “1 49”. Is also displayed in the Hypertension
Diagnostics Suite software during device diagnostics, or at the table view
under “Device Information”
Calibration Date / Time
Identifies the last calibration date and time of an Ambulo 2400 device. Is
displayed in the Hypertension Diagnostics Suite software during device
diagnostics, or at the table view under “Device Information”

16
MAINTENANCE & CALIBRATION
Device Cleaning & Disinfecting
Warning
• Remove the batteries from the device before inspecting or cleaning.
• Do not get the device wet or immerse in water.
• Do not drop the device or subject it to shock and/or vibration.
• Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may damage
equipment surfaces.
Recommended Supplies
• Clean lint free cloth
• Mild detergent
• Luke warm water
• 10% Household bleach and water solution (Sodium Hypochlorite solution consisting of a minimum 1:500
dilution and maximum of 1:10 dilution for disinfecting use only)
Device Cleaning
Clean the exterior surface of the device with a damp, soft, lint-free cloth using a solution of mild detergent diluted in
water. After cleaning thoroughly dry off the device with a clean, soft cloth or paper towel.
Device Disinfecting
Clean the device per the instructions defined above, then wipe the exterior of the device with a damp (not wet), soft,
lint-free cloth using a solution of 10% bleach and water. Allow the device to air dry after disinfecting before
returning to use.
Cleaning the Cuffs
1. Prior to washing, remove any internal cuff bladders and engage the Velcro hook and loop fasteners to prevent
lint from collecting in the hooks.
2. For general cleaning of cuffs, use a soft, lint-free cloth lightly moistened with a mild soap and water solution.
Be careful not to get liquid inside of the tubes. Allow to air dry.
3. For excessive perspiration marks or odor, the exterior of the cuff can be hand-washed under running water with
a mild detergent. Do not allow water to enter the bladder including with single-piece cuffs without an internal
bladder. Allow to air dry.
4. If required, use of non-chlorine bleach is recommended. Chlorine bleach solutions will shorten the service life
of the cuff.
5. Sterilize the cuff and bladder using commercially available disinfectants. Note that some disinfectants may
cause skin irritation and dark colored disinfectants may stain the cuff. Test a single cuff to ensure that no
damage or staining will occur. Follow the manufacturer’s instructions and thoroughly rinse each component to
remove any residual disinfectants. Allow the components to air dry and then insert the bladder.
6. Cuffs can be sterilized with Ethylene Oxide. Do not autoclave or iron the cuff as the hook and loop fasteners
will melt at temperatures above 325°F (162°C).

MAINTENANCE & CALIBRATION
17
7. Use caution with excess liquid.
8. Do not use excessive drying techniques such as forced heat.
WARNING: Prevent liquid from penetrating the device and do not attempt to clean/disinfect the
device or cuff by submerging into a liquid, autoclaving, or steam cleaning.
WARNING: Certain maintenance and calibration operations of the Ambulo 2400 system, such as
safety processor calibration and deflation rate calibration, should only be performed by Mortara authorized
service personnel.
Confidence Test
• Place 2 AA batteries in the device, and verify that it successfully powers on, making note if the software version
displayed on the screen is not current (example “1 49”). If the device display eventually alternates between the
time and “PAUSE”, proceed to the next step. If the device displays “HE##”, “SE##” or something other than
PAUSE/time, refer to the “System Troubleshooting Chart”.
• If firmware is version 1.49 or older, it is recommended that the main processor receive software upgrade (to the
current version) and calibration. But first, verify that the device passes communication testing below.

MAINTENANCE & CALIBRATION
18
Maintenance and Calibration Procedure
Preventive maintenance and Calibration of the Ambulo 2400 is recommended to be performed at least once per
year.
In order to configure, calibrate and test the Ambulo 2400 ABPM system, a set of custom-developed utilities –
henceforth referred to as CCT (Command & Control Terminal) - must be installed and used on a computer.
Developed using the Python programming language, these utilities can run under Microsoft Windows using the MS-
DOS Command Prompt or in a Linux-based environment.
NOTE: Before proceeding with any CCT commands, you must first install and setup the Hypertension
Diagnostics Suite software, as well as Python and CCT with the following instructions.
1. Install current Mortara Hypertension Diagnostics Suite software. This will install the Ambulo 2400 USB driver,
which is necessary for the device to be recognized by the PC.
2. Download and install Python 2.6.1 (location to be determined). Make note of install folder for next steps. For
example, C:\Python26.
3. Download Pyserial 2.5 (Python Serial Extension) (location to be determined) to Python install folder (from
previous step) and install.
4. Download Pywin32-210 (location to be determined) to Python install folder and install.
5. Download and install CCT application software (file location to be determined) to local directory (for
example, C:\CCT).
Perform a Visual Inspection of the Following Items:
• Device outer casing, coupler and LCD faceplate. Make note of any heavy wear, damage or signs of drop. If
faceplate is cracked, this is likely an early version of this part (which was prone to cracking) and it is
recommended that the entire top cover be replaced (the revised LCD faceplate is more durable). Some early
Tiba devices also have a plastic air socket, which has since been replaced with a more durable metal design. In
the event that a Tiba branded Ambulo 2400 needs service of the outer case, it is recommended that the complete
case be replaced with Mortara branded plastics.
• If a customer has included accessories with their Ambulo 2400 system, inspect hoses and cuffs for excessive
wear or leaks. If accessories are noted as being in questionable condition, or if the device is suspected of having
leaks, these accessories will be identified during the “leak test” portion of this procedure. If a puncture is
discovered in the hose, it may be possible to trim the damaged piece and salvage the accessory. Otherwise it is
recommended that the customer replace the accessory.