Midmark 8014, 8015 User Manual

003-2981-00 Rev. B (2/21/17)

Software Version 1.2V

User Guide

For Models:

8014

Blood Pressure

8015

Blood Pressure,
Pulse Oximetry

Cardell Insight

Veterinary Monitor

®

i

Product Information

Dealer:

Date of Purchase:

Model / Serial Number:

Midmark Authorized
Service Company:

Model & Serial
Number Label

ii

Table of Contents

Product Information .............................................. i

Important Information ............................... 4

1.1 Operating Environment ............................. 4

1.2 Electromagnetic Interference .................... 4

1.3 Authorized CE Representative ................. 4

1.4 Disposal of Equipment .............................. 4

Introduction ............................................... 5

2.1 Indications for Use .................................... 5

2.2 Contraindications ...................................... 5

2.3 Brief Description ....................................... 5

2.4 Patient Environment ................................. 7

Unpacking the Monitor ............................. 8

3.1 Initial Inspection ........................................ 8

3.2 Monitor Checklist ...................................... 8

3.3 Optional Mounting Accessories ................ 9

Symbols ................................................... 10

4.1 Safety Symbols ....................................... 10

4.2 Symbols on the Monitor .......................... 10

Symbols near Patient Connection .. 12

Symbols on Front Panel ................. 12

4.3 Symbols on Packaging ........................... 12

4.4 Touchscreen Keys on Display ................ 13

4.5 Alarms/Audio State Icons ....................... 13

4.6 Patient Mode Icons ................................. 14

4.7 Workflow Icons ....................................... 14

4.8 Touchscreen Controls on Display ........... 14

Monitor Safety Measures ........................ 18

5.1 Overview – Dangers ............................... 18

5.2 Overview – Warnings .............................. 18

5.3 Overview – Cautions ............................... 21

5.4 Overview – Notes ................................... 22

5.5 Installation and Functional Verification ... 23

Monitor Overview .................................... 24

6.1 Front Panel ............................................. 24

Front Panel Controls ....................... 24

6.2 Rear Panel .............................................. 25

Rear Panel Ports & Connections: ... 25

6.3 Left Side View ......................................... 26

6.4 Right Side View ...................................... 27

6.5 Patient Connections ................................ 27

NIBP Cuff Hose Connection .......... 27

SpO

2

Patient Connection ............... 27

Speaker .......................................... 28

6.6 Battery .................................................... 28

Monitor Operation................................... 30

7.1 Operating Modes ................................... 30

7.2 Turning the Monitor “On”........................ 30

7.3 Turning the Monitor “Off”........................ 32

7.4 Power Up Screen ................................... 32

7.5 Workflow ................................................ 33

7.6 Monitor ID Selection ............................... 35

7.7 Main Screen Display .............................. 36

Date and Time ............................... 37

Screen Lock Icon ........................... 37

Patient Mode (Type) ...................... 38

Patient Information Button ............. 40

Clinician Information ...................... 41

NIBP Numeric Field ....................... 42

SpO

2

Fields .................................... 43

Waveforms ..................................... 43

7.8 Alarms and Messages ........................... 46

Message Area (Alarms) ................. 47

Numeric Area (Alarms) .................. 48

Alarm Log ....................................... 48

Audio Silence ................................. 49

Alarm Pause .................................. 49

Alarm Limits and Settings .............. 50

Audible and Visual Indicators......... 53

7.9 Error Messages on the Display .............. 54

Menu Setup ............................................. 58

8.1 Entering the Setup Menu ....................... 58

8.2 Alarm Pause .......................................... 58

8.3 Audio ...................................................... 59

8.4 Save Trends ........................................... 60

8.5 Patient Setup ......................................... 60

Patient Information ......................... 60

Clinician Information ...................... 62

8.6 Restore User Defaults............................ 63

8.7 Clear Trends .......................................... 64

8.8 Administrator .......................................... 64

Alarms ............................................ 64

System ........................................... 66

iii

Service ............................................ 73

Configuration .................................. 73

Factory ............................................ 73

Display ............................................ 74

Blood Pressure Monitoring .................... 75

9.1 General Information ................................ 75

9.2 Safety Measures ..................................... 75

9.3 Tips ......................................................... 77

9.4 Cuff Selection and Application ................ 78

Cuff Placement for Cats .................. 79

Cuff Placement for Dogs ................. 80

Cuff Placement for Large Animals .. 80

9.5 NIBP Measurement ................................ 81

NIBP Alarm Limits ........................... 82

Manual Mode .................................. 83

Automatic (AUTO) Mode ................ 83

STAT Mode ..................................... 83

Pulse Oximetry Monitoring .................. 85

10.1 Safety Measures ..................................... 85

10.2 Alarm Limit Values .................................. 90

10.3 SpO2 Measurement ................................ 91

Attachment Procedure .................... 91

Removing the Interface Cable ........ 92

10.4 Plethysmograph ...................................... 93

10.5 SpO2 Messages ...................................... 94

Trends ................................................... 95

Cleaning ................................................ 96

12.1 Overview ................................................. 96

12.2 Display .................................................... 96

12.3 Monitor .................................................... 96

12.4 Blood Pressure Cuffs .............................. 97

12.5 Pneumatic Tubing ................................... 98

12.6 SpO2 Interconnect Cable ........................ 98

12.7 SpO2 Sensors (Reusable) ...................... 98

Maintenance .......................................... 99

13.1 Maintenance Intervals ............................. 99

Preventative Maintenance .............. 99

Painted Metal / Plastic Surfaces

.... 99

13.2 Oximetry Calibration Check .................... 99

13.3 NIBP Calibration Check ........................ 100

13.4 Monitor Battery ..................................... 101

Replacing the Monitor Battery ...... 101

Accessories ........................................ 104

Specifications ..................................... 106

15.1 Monitor Configuration Examples .......... 106

15.2 NIBP Measurement .............................. 106

15.3 Oximetry ............................................... 107

15.4 Patient Alarms ...................................... 108

15.5 Control Panel ....................................... 109

15.6 Power ................................................... 109

15.7 Storage/Transport Environment ........... 109

15.8 Physical Dimensions & Weight ............ 110

15.9 Settings and Defaults ........................... 110

Initial Inflation Pressure ................ 110

Main Screen ................................. 111

Setup Screen ............................... 111

Administrator Screen ................... 112

15.10 Standards ............................................. 113

Electromagnetic Compatibility .......... 114

Warranty Information ........................ 117

After-sale Service and Support ......... 120

4

Important Information

1.1 Operating Environment

1.2 Electromagnetic Interference

This product is designed and built to minimize electromagnetic interference with other devices.
However, if interference is noticed between another device and this product:

 Remove interfering device from room
 Increase separation between monitor and interfering device
 Contact Midmark if interference persists

1.3 Authorized CE Representative

Countries in the EU should direct all questions, incidents, and complaints to Midmark’s Authorized CE
representative listed below:

Estan AB
Prastgarden
Ostra Stenby
S-61032 Vikbolandet
Sweden

1.4 Disposal of Equipment

At the end of product life, the monitor, accessories, and other consumable goods may become
contaminated from normal use. Consult local codes and ordinances for proper disposal of equipment,
accessories and other consumable goods. EU distributors and treatment facility personnel may contact
the manufacturer to obtain relevant information concerning WEEE Selective Treatment and Recycling.

Characteristic

Specification

Temperature:

-20°C to 60°C (-4°F to 140°F)

Humidity:

15 to 95% RH, non-condensing

Altitude:

0 to 40,000 ft (101 to 19 kPa)

WARNING

The monitor may not meet performance specifications if stored or used outside temperature and
humidity ranges. When moving the monitor from a storage location, wait at least one-hour or more
prior to use to allow the monitor to adjust to room temperature.

5

Introduction

The Cardell Insight is a multi-parameter monitor measuring Blood Pressure and Oxygen Saturation.
Non-invasive Blood Pressure is measured using the oscillometric step-deflation technique determining
systolic, diastolic, mean arterial pressure (MAP) and pulse rate. The Pulse Oximeter function
continuously monitors and displays values for functional arterial hemoglobin saturation and a pulse

rate.

2.1 Indications for Use

The Cardell Insight monitor is indicated for use on animals as a portable, multi-parameter, variable
acuity device for use by qualified veterinarians and technicians in a variety of veterinary centers, for
non-invasive spot checking, and/or continuous monitoring and/or recording of:

 Blood pressure and pulse rate;
 Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate

2.2 Contraindications

 Do not use on a limb with a vascular shunt
 Do not use in a hyperbaric chamber
 Do not use near an MRI machine
 Do not use near flammable anesthetics
 Do not place SpO2 sensors near electro-cauterization
 Do not use on patients connected to a cardiopulmonary bypass device
 Do not use on patients connected to intra-aortic balloon pump device
 Do not use on patients with peripheral convulsions, tremors or seizures
 Not intended for use with severe arrhythmia
 For contraindications of SpO2 sensors, consult the manufacturer’s directions for use
 No other contraindications are known at this time

2.3 Brief Description

The Cardell Insight multi-parameter monitor is compact, lightweight and portable, allowing it to be easily
carried and used in a variety of clinical settings. The monitor is powered by AC Line Power or by an
internal Lithium Ion (Li-ion) rechargeable battery pack. The internal battery pack charges when the
monitor is plugged into an AC Line power source. The monitor is equipped with a touchscreen
interface. The touchscreen presents touch targets allowing the monitor to be configured for various type
patients and clinical settings. The LCD screen displays various system alarm messages (physiologic

6

and equipment). These messages direct the user to check conditions such as limit violations, sensor
attachment, battery state, air leaks and measurement problems.

The non-invasive Cardell blood pressure technology (NIBP) parameter automatically inflates an
occluding cuff and, using the oscillometric measurement technique, determines systolic, diastolic and
mean arterial pressure and pulse rate. Measurement results along with user prompts and error
messages are displayed on the front panel. The frequency of NIBP determination can be selected by
the user in varied times between one and ninety minutes. The Auto and Manual operating modes
cover a variety of clinical uses. The Start BP Options feature provides the user with a selection of
inflation pressures for use while in Spot-Check workflow mode or adaptive blood pressure typically
used during continuous patient monitoring. The Signal Quality Status (SQS) indicator provides an
assessment of signal quality and level of motion artifact present during the NIBP measurement.

The Cardell Insight monitor provides the option of Covidien OxiMax pulse oximetry technology. The
pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the
absorption of red and infrared light passing through the tissue. Changes in absorption caused by
pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The
oximeter requires no routine calibration or maintenance.

Oxygen saturation and heart rate are displayed on the LCD screen. A bar graph gives the user a

relative signal quality indication. An audio “beep” can be enabled that is generated each time the SpO

2

module detects a pulse. The display screen can be configured to display the SpO2 Plethysmograph.
The Cardell Insight monitor provides the flexibility to easily configure the monitor for use in various

clinical workflows. The monitor can be specifically configured to operate in either Spot-Check or
Continuous Monitoring Mode.

The monitor configuration can be saved as user Defaults (institutional settings) and subsequently
copied to a USB flash drive for cloning additional Cardell Insight monitors to the same configuration.

Safety features include the ability for clinicians to lock (and un-lock) the main screen to prevent an
unauthorized user from accessing and changing monitor settings. Higher level administration screens
typically used to establish institutional and hospital settings are password protected.

Upper and lower alarm limits are provided for all parameters: NIBP, SpO2, PR. Active alarms can be
managed using Audio Silence and Alarm Pause features. Active alarms are easily distinguished on the
display screen by the flashing parameter field.

The Cardell Insight monitor provides an extensive list of high end features in a highly compact and
portable design. Features specifically designed to enhance workflow, efficiency, and patient safety
include:

 Standby Mode for enhanced patient workflow and alarm management
 Alarm Log for recall and display of patient and equipment alarms, alarm limit settings

changes

 Screen Lock/Unlock to prevent unauthorized users from accessing the monitor
 SpO2 alarm acknowledgement for management of equipment alarms (e.g., SpO2 check

sensor placement)

 Auto Dim display screen for enhanced nighttime operation

7

 Save Snapshots available in Spot-Check and Continuous Monitoring workflow modes

 Start BP Options allow the Clinician to select the appropriate Initial Inflation Pressure from a

list while operating in Spot-Check workflow mode

 Automatic trend capture – 1 minute average of continuously monitored physiologic

parameters as well as interval capture of non-continuously monitored parameters (e.g.
NIBP)

 Second speaker tone to inform the clinician an alarm has persisted for an extended period

of time and provide back-up to the primary speaker

 Li-ion battery for extended operational use and transport
 Light weight for ease of use during transport
 Rugged design: Rated for use during professional transport

2.4 Patient Environment

The Cardell Insight monitor has been tested with specific parts of the “system” used within the Patient
Environment (refer to Figure 1). The parts of the “system” that can be used in the Patient Environment
are defined in Table 1:

Figure 1: Patient Environment

Table 1: Parts of the System

Cardell Insight multi-parameter monitor

Appropriate Accessories, Refer to Section 14: Accessories

Power Supply and AC Line Cord

1.5 m

Caution

If the monitor has been configured for use in Spot-Check workflow mode, selecting OK from the

“Save snapshot? Screen” will automatically clear patient information, and restore the monitor to

user established default settings

8

Unpacking the Monitor

3.1 Initial Inspection

Before unpacking the monitor, inspect the packaging for damage. If there are any signs of damage to
the package, a claim should be filed immediately with the shipping agent. It is the receiver's
responsibility to notify the carrier's local office to arrange for the pickup of the damaged items. Save
the damaged shipping carton as evidence.

Contact Midmark to report external damage and to arrange for repair or replacement of damaged
equipment.

The shipping carton should contain the items listed below. Unpack the monitor and account for each
item. Inspect each item for signs of external damage, dents, cracks, scratches, etc. If an item is
missing or damaged, contact Midmark within 15 days of delivery.

Record the monitor model, serial number and date of purchase at the front of this Manual.

3.2 Monitor Checklist

Qty.

Description

1

Cardell Insight monitor w/Lithium-ion battery (installed)

1

Power Supply

1

AC Power Cord (*)

1

Cardell Insight User Manual

1

Veterinary Blood Pressure Start Up Kit
Includes: 2m Hose, Vet Blood Pressure Cuffs and Cuff Selector Guide- Applied Part

For models with SpO2 (Nellcor OxiMax) option installed:

1

SpO2 Interconnect Cable

1

Vet SpO2 Sensor - Applied Part

(*) The monitor is shipped with the appropriate line cord for the country and or voltage being used.

Note

Actual shipping carton contents will vary depending on monitor configuration, accessories and
software options ordered

9

3.3 Optional Mounting Accessories

Several mounting configurations are available to fit your needs. Refer to Section 14: Accessories for
part number information. Contact Midmark for further information.

Caution

Do not use any other power supply other than the one supplied by Midmark. Refer to Section 14:
Accessories for power supply part number information

10

Symbols

The following is a summary of all symbols used on the monitor and accessories. Symbols may occur
on the product or on its packaging.

4.1 Safety Symbols

4.2 Symbols on the Monitor

Caution

Input

Indicates the polarity of the DC power input

Note

Directions that make it easier to use the monitor.

Caution

Indicates a potentially hazardous situation which may result in minor or moderate injury. It may also
be used to alert against unsafe practices.

WARNING

Indicates a potentially hazardous situation which could result in serious injury.

DANGER

Indicates an imminently hazardous situation which will result in serious or fatal injury. This symbol
is used only in the most extreme conditions.

Equipment Alert

Indicates a potentially hazardous situation which could result in equipment damage.

11

Direct Current

European CE Mark according to Council Directives 2014/30/EU and 2014/35/EU

Indicates this monitor is subject to the Waste Electrical and Electronic Equipment
Directive in the European Union

Keep dry
IPX1

Protected against dripping water (refer to IEC 60529)

Connection for USB Memory stick

Ethernet connection (future use)

Two-way Communication and/or Cardell Insight Printer Port (Future Use)

Federal law restricts this device to sale by or on the order of a veterinarian or licensed
practitioner

Follow instructions for use

Product has been independently tested and certified by a Nationally Recognized
Testing Laboratory (NRTL)

Part Number Reference

Manufacturer

Manufacture Date

12

Symbols near Patient Connection

Indicates protection against the effects of the discharge of a cardiac defibrillator.
Patient connections are Type BF and protected against defibrillation

®

NIBP Hose and Blood Pressure Cuff Connector, CASMED MAXNIBP NIBP (Motion
Artifact eXtraction Technology)

SpO2

Pulse Oximeter Input Connector, accompanied by one of the following:

Nellcor SpO2 Technology

Symbols on Front Panel

ON/Off – Turns the monitor On or Off

4.3 Symbols on Packaging

Symbol used to indicate the minimum and maximum storage and transport
Temperatures. Refer to Section 1.1:Operating Environment

.

Symbol used to indicate the minimum and maximum relative humidity for storage
and transport. Refer to Section 1.1:Operating Environment

.

Symbol used to indicate the minimum and maximum atmospheric pressure for
storage and transport. Refer to Section 1.1: Operating Environment

.

Fragile, handle with care

This end up

13

4.4 Touchscreen Keys on Display

The monitor uses touchscreen keys to facilitate monitoring functions. Touch keys are located on the far
right-hand side of the display screen in a vertical fashion. The keys are fixed and cannot be changed or
reconfigured.

Silence

Alarm Silence touch area - Pauses Audio for 1, 1.5, or 2 minutes

Standby

Standby touch area - Places the monitor into standby mode; touching the screen
will return the monitor to full operation (NO alarms are generated while in Standby)

Save

Save touch area - Saves snapshot of patient values to trend storage

Trends

Trends touch area - Display a record of trends and Saved Snapshots in
tabular form

Setup

Setup touch area - Enter the Setup screens to configure the monitor

Home

Home touch area - Returns the monitor’s display to the Main screen

4.5 Alarms/Audio State Icons

Alarms Pause - Indicates the generation of all Alarms has been temporarily paused

(by pressing “Alarm Pause” in the Setup menu).

Audio Pause - Indicates the audio associated with current Alarms has been

temporarily paused by pressing “Silence”

Note

Standby is used to enhance clinical workflows:

o Allows attachment of patient interface cables to the monitor in advance of patient
o The monitor automatically reverts to active monitoring when patient data is detected
o Provides the user with the option to suspend all patient monitoring

14

4.6 Patient Mode Icons

Horse: Sets the Cardell Insight alarm defaults to horse.

Dog: Sets the Cardell Insight alarm defaults to dog.

Cat: Sets the Cardell Insight alarm defaults to cat.

4.7 Workflow Icons

CONT

CONT - Continuous mode

SPOT

SPOT - Spot Check mode

4.8 Touchscreen Controls on Display

Provides the user with interactive touchscreen monitor controls and activity buttons used to configure
monitor settings, limits etc.

Touchscreen
Control:

Example:

Description:

Alarm Log
Arrows (right or

left)

Allows user to navigate to the right or left to
view the entire table/log.

Alarms Log
Review

Allows user to navigate to the beginning or
end of the Alarm log.

Backspace

Used to move the cursor back one space or
more.

Cancel

Located in all Setup screens. Used to exit a
screen without making a change.

Clear

Used to remove current entry in a data field.

15

Clear Trends

Located in the Setup menu.
Allows the user the ability to remove

all current Trends stored on the monitor.

Close

Select to exit the screen being viewed.

Copy Settings to
and from USB
Flash Drive

Allows user to copy settings/defaults from one
monitor to another or to retain a copy of the
current monitor default settings for future
reference.

Demo Mode

Indicates the monitor has been placed into
Demonstration Mode from a password
protected screen.

No active monitoring while in Demo Mode.

Drop-down

Selection keys typically appearing in the
Setup menu.

Numeric Keypad

Used to enter information (passwords, patient
weight, etc.).

OK Located in all Setup screens. Used to confirm
a setting and return to prior screen.

On/Off

Used to turn a feature or setting On or Off.

Patient
Identification

Used to enter the current patient ID. When
selected opens a screen allowing patient
specific information to be entered using an on
screen QWERTY keyboard.

Restore user
Defaults

Allows the user to reset the monitor to the
previously saved user Defaults.

16

Screen Lock
Screen Unlock

Used to limit access to menus by
unauthorized users.

When padlock icon is selected (upper right
hand corner of display screen) the Enter
password screen is opened.

User is required to enter a password to lock
access to menus or unlock access to menus.

Password is the current date displayed on the
main menu (MM/DD/YY).

Example:
Current date: 12/10/2016
Enter: 12102016

SpO2 Alarm
Acknowledge

Selecting this button silences the audible
SpO2 equipment alarm and clears the alarm
messages (e.g., SpO2 check sensor
placement)

Start BP

* Typically used for Spot-Check workflow
mode Start BP Options provide workflow
flexibility (Spot-Check, Continuous Monitoring
workflow modes – adaptive measurements).

Start/Stop NIBP

* Typically used during continuous monitoring
Used to start or stop an NIBP measurement

(Start changes to Stop when selected).

Touch screen to
resume
monitoring

When the monitor is in Standby Mode, allows
user the option to initiate patient monitoring at
any time by touching the monitor display
screen.

Up and Down
Arrow

Typically used for setting adjustment or
navigation (e.g. increase audio volume or
scroll through Trends log)

17

User Defaults

Located in the password protected Setup
System menu.

Allows the institution to establish and save
settings and monitor features (profile) as user
Defaults.

Yes / No

Yes - Used to express agreement with a
posed question. (e.g., “New Patient?”).

No - Used to express disagreement of a
posed question. (e.g., “New Patient?”).

18

Monitor Safety Measures

5.1 Overview – Dangers

5.2 Overview – Warnings

DANGER

The Li-Ion battery should not be incinerated.

WARNING

 The monitor needs special precautions regarding EMC and needs to be installed and put

to service according to the EMC information provided in the Electromagnetic Compliance
section.

 Portable and mobile RF communications equipment may affect the monitor and should be

used no closer to any part of the monitor, including cables, than the recommended
separation distance calculated in the Electromagnetic Compliance Section.

 The monitor is intended only as an adjunct in patient assessment. It must be used in

conjunction with clinical signs and symptoms.

 The monitor Alarm Volume should be verified suitable for the area in which they are used.
 Do not use this instrument for any purpose other than specified in this Manual. Doing so

will invalidate the monitor’s warranty.

 Do not connect more than one (1) patient to the monitor.
 To remove all power from the monitor, the AC plug must be disconnected from the wall

outlet or the power cord must be removed from the rear of the monitor and the battery
pack must be removed.

 Do not plug the monitor into an outlet controlled by a wall switch.
 Before each use, verify that the alarm limits are appropriate for the patient being

monitored.

 Before each use, make sure that the monitor default alarm settings are appropriate for the

specific patient being monitored.

 The position of patient, physiological condition, and other factors affect the readings.

19

WARNING

 Occasionally, electrical signals at the heart do not produce a peripheral pulse
 If a patient’s beat-to-beat pulse amplitude varies significantly (for example, pulsus

alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and pulse rate
readings can be erratic and an alternate measuring method should be used for
confirmation.

 Where the integrity of the external protective conductor in the installation or its

arrangement is in doubt, EQUIPMENT shall be operated from its INTERNAL
ELECTRICAL POWER SOURCE.

 Do not, under any circumstances, perform any testing or maintenance on the monitor,

power supply or power cords while the unit is being used to monitor a patient. Unplug the
power cords before cleaning or servicing the monitor. The user should not perform any
servicing except as specifically stated in this Manual.

 Do not touch part of non-medical electrical equipment in the patient environment after

removal of covers, connectors, etc. without the use of a tool which operate at voltages not
exceeding 25 VAC or 60 VDC and the patient at the same time.

 Do not use a frayed or damaged power cords, or any accessory if you notice any sign of

damage. Contact Midmark for assistance.

 Equipment is not suitable for use in the presence of FLAMMABLE ANESTHETICS.
 Equipment is not intended to be used in Oxygen Enriched Atmospheres.
 Do not gas sterilize or autoclave the monitor.
 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: 1) Use of the accessory in the Patient
Environment; and 2) Evidence that the safety certification of the accessory has been
performed in accordance with the appropriate IEC 60601-1 collateral and particular
harmonized national standard.

 Do not use the monitor in the presence of Magnetic Resonance Imaging (MRI)

equipment.

 Do not place liquids on top of the monitor. Do not immerse the monitor, power supply or

power cords in water or any liquid. If unit is accidentally wetted it should be thoroughly
dried. The rear and bottom cover can be removed by a qualified service technician to
verify absence of water.

 ELECTRICAL SHOCK – To reduce the risk of electrical shock, do not remove the back or

bottom cover. Refer all servicing to qualified personnel.

20

WARNING

 ELECTROMAGNETIC COMPATIBILITY (EMC) – The equipment needs special

precautions regarding EMC. Refer to the Electromagnetic Compliance section for
additional information regarding EMC. Be aware that strong electromagnetic fields may
interfere with monitor operation. Interference prevents the clear reception of signals by
the monitor. If the hospital is close to a strong transmitter such as TV, AM, or FM radio,
police or fire stations, a HAM radio, an airport, or cellular phone, their signals could be
picked up as signals by the monitor.

 ACCURACY – If the accuracy of any measurement does not seem reasonable, first

check the patient’s vital signs by alternate means and then check the monitor for proper

functioning.

 CABLES - Route all cables away from patient’s throat to avoid possible strangulation.
 ACCESSORIES – The use of accessories and cables other than those specified, with the

exception of the accessories and cables sold by Midmark as replacement parts, may
result in increased emissions or decreased immunity of the monitor.

 ACCESSORIES – It is the responsibility of the organization and/or user to verify the

compatibility of the monitor, probes, and cables before use, otherwise patient injury can
result.

 DEFIBRILLATION – Do not come in contact with patients during defibrillation. Serious

injury or death could result.

 DISPOSAL – Dispose of the packaging material, observing the applicable waste control

regulations.

 SITE REQUIREMENTS – For safety reasons, all connectors for patient cables and

sensor leads are designed to prevent inadvertent disconnection, should someone pull on
them. Do not route cables in a way that they may present a stumbling hazard. For
devices installed above the patient, adequate precautions must be taken to prevent them
from dropping on the patient.

 STACKING – Where a monitor is used adjacent to or stacked with other equipment, the

monitor should be observed to verify normal operation in the configuration in which it will
be used.

 Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or

methemoglobin, may affect the accuracy of the measurement.

 For data accuracy and consistency, as well as patient comfort, adhere to the guidance in

Section 9.3: Tips.

 Cardiogreen and other intravascular dyes, depending on the concentration, may affect

the accuracy of the oximeter measurement.

21

5.3 Overview – Cautions

WARNING

 A NIBP monitor does not operate effectively if a patient is having seizure activity,

convulsions or tremors. When a patient is experiencing arrhythmias during a NIBP
measurement, the accuracy of the pulse determination may be affected or the time
needed to complete a measurement may be extended. The monitor will not make a
determination beyond 120 seconds.

 Setting the Upper Alarm limit to the extreme high value can render the Upper Alarm Limit

detection ineffective.

 Setting the Lower Alarm limit to the extreme low value can render the Lower Alarm Limit

detection ineffective.

Caution

 Pressing the touchscreen with a sharp or pointed instrument may permanently damage

the touchscreen. Press the touchscreen using only your finger.

 Inspect the monitor, air hose, and sensors for any damage prior to operation. If any

damage is noted, the monitor should not be used until it has been serviced. The monitor
should be repaired only by authorized personnel

 Use only Midmark approved accessories and sensors to preserve the integrity, accuracy

and the electromagnetic compatibility of the monitor.

 The oximeter is factory calibrated to determine the percentage of arterial oxygen

saturation of functional hemoglobin.

 Some sensors may not be appropriate for particular patients. If at least ten (10) seconds

of adequate height pulse on the Plethysmograph waveform cannot be observed for a
given sensor, change sensor location or sensor type until this condition is achieved.

 If the monitor fails to respond (including the display and touchscreen), do not use it until

the situation has been corrected by qualified personnel.

 ACCIDENTAL SPILLS – In the event fluids are accidentally spilled on the monitor, take

the monitor out of operation and inspect for damage.

 ELECTROSURGERY – Measurements may be affected in the presence of strong

electromagnetic sources such as electro surgery equipment.

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5.4 Overview – Notes

Notes

 There are no known risks with common disposal of equipment or accessories; however,

the disposing of accessories should follow in accordance with local hospital policies. The
user should ensure these policies do not conflict with any local, state or federal
guidelines.

 The monitor is suitable to be connected to public AC mains power.
 The monitor is not “Category AP or APG Equipment”.
 The monitor is for “Continuous Operation”.
 The applied parts are “Type BF Defibrillation Proof”.

Caution

 GROUNDING – Do not defeat the three-wire grounding feature of the AC power cord by

means of adaptors, plug modifications, or other methods. Do not use extension cords of
any type. Do not connect the monitor to an electrical outlet controlled by a wall switch or
dimmer.

 INTERFACING OTHER EQUIPMENT – Monitoring equipment must be interfaced with

other types of medical equipment by qualified biomedical engineering personnel. Be
certain to consult manufacturers’ specifications to maintain safe operation.

 The monitor may not meet performance specifications if stored or used outside

temperature and humidity ranges. When moving a monitor from a storage location, wait at
least one hour prior to use to allow it to adjust to room temperature.

 Remove the battery if the monitor is not likely to be used for some time.
 Under certain conditions, the monitor provides “DRIP-PROOF” level of protection from

ingress to moisture. Do not expose the monitor to extreme moisture levels such as direct
exposure to rain. Exposure to extreme moisture levels may cause incorrect or inaccurate
performance or monitor failure during or after exposure.

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5.5 Installation and Functional Verification

The user should be positioned in front of the monitor, within arm’s length to allow operation of the
touchscreen as well as connection/disconnection of cables. The user should be positioned to allow
hearing of audible alarm tones generated by the monitor.

Perform the following steps to set up the monitor.
Table Top

1) Position the monitor on a flat surface, away for the any edge.

2) Route the patient cables so that if pulled the monitor will not fall.

Perform the following steps to power on the monitor and test the Alarm Operation:

1) Connect the supplied AC power cord to the power supply.

2) Connect the AC power cord plug to a wall outlet. The wall outlet should not be controlled by
a switch.

3) Connect the power supply’s DC power cord into the DC Connection in the rear of the
monitor

4) Power on the monitor.

5) Verify the monitor is configured for the proper type patient: Horse, Dog or Cat

User-initiated Testing of Alarm Signal Generation
Once the monitor is on, verify the unit is functioning properly by performing the following functions:

1) Set the NIBPs Lower Alarm Limit to Off, and the NIBPs Upper Alarm Limit to 40 mmHg.

2) Attach the NIBP Cuff to a NIBP Simulator or your finger.

3) Start a NIBP Measurement and allow it to complete.

4) Verify a NIBPs Upper Alarm Limit violation is created; Visual and Audio annunciation.

5) Remove and Silence the NIBPs Upper Alarm Limit violation.

Caution

Testing of the Alarm operation should be done at least once every 6 months. The recommended
functional verification may be completed by a qualified user.

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Monitor Overview

6.1 Front Panel

Figure 2: Front Panel View

Front Panel Controls

On/Off:

Press once, to turn “ON” (if it was Off). The button is illuminated
when power is on.

To turn “Off”, press and hold for two (2) seconds.

POWER LED:
Indicates External A/C Power is connected.

TOUCHSCREEN:
Provides Graphical user Interface (GUI) for controlling and

configuring the monitor.

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6.2 Rear Panel

Figure 3: Rear Panel View

Rear Panel Ports & Connections:

Figure 4: Rear Input Panel

DC Connection

Receptacle for the DC power supply is located on the rear panel. Use only PN 015-3604-00 Power
Supply.

Note

The serial number label is located on the back side of the monitor, next to the SN symbol.

Battery

Compartment

Model, Serial

Number Label

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USB Connection

Note: Not all flash drives are supported.

The USB connection allows for the following:

 Perform software upgrades via USB Flash Drive
 Copy monitor Settings to or from USB Flash Drive
 Copy monitor Logs to USB Flash Drive
 Download Trend Data

Ethernet Connection (Future)

Receptacle for Ethernet connectivity.

External Device Interface (Future)

Receptacle for serial communication.

6.3 Left Side View

SpO2 Connector (if equipped)

NIBP Connector

Figure 5: Left Side Panel View and Connectors

SpO2 connector
(if equipped)

Speaker
NIBP

Connector

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6.4 Right Side View

Figure 6: Right Side Panel View

6.5 Patient Connections

NIBP Cuff Hose Connection

The NIBP inflation hose is connected to the monitor. (Refer to Figure 5). An appropriately sized cuff
for the patient’s limb must be connected to the hose prior to use. Pull on the connector sleeve at the
end of the hose to release hose from monitor.

SpO2 Patient Connection

*For Monitors equipped with SpO2:

The SpO2 Patient cable is connected to the monitor where the SpO2 logo is located (refer to Figure 5).
The SpO2 Sensor is then connected to the SpO2 Patient cable.

Note

The SpO2 Patient cable is keyed and can only be inserted one way.

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Speaker

The monitor is equipped with an internal speaker to indicate the presence of alarm conditions.

6.6 Battery

The monitor is equipped with an internal rechargeable battery. The battery is charging whenever the
monitor is plugged into a power source. A green Battery Charging Visual Indicator (located to the right
of the On/Off button) on the front panel is lit when the battery is charging.

Batteries will self-discharge when they are not used. It is recommended that the battery be maintained
at full charge by leaving the monitor connected to a power source whenever possible.

The standard 10.8 Volt 7800 mAhr battery pack, when new, fully charged, is capable of approximately
10 hours of operation when the monitor is set in the 5-minute Automatic Mode (Continuous SpO2
measurements).

The battery icon appears when the monitor is disconnected from the mains power. The icon
provides an indication of relative battery change level remaining.

WARNING

Do not place the monitor left side speaker grill against a solid surface. This will cause the alarm
tones to be muffled.

Equipment Alert

Dispose of battery per the manufacturer’s instructions.

Note

Charge battery fully before initial use.

Caution

This product contains a rechargeable Li-ion battery that is recyclable. Under various state and
local laws, it may be illegal to dispose of this battery into the municipal waste stream. Check with
your local authorities for instructions on recycling options in your area.

DANGER

Risk of fire, explosion, or burns. Do not short circuit, crush or expose battery to high temperature,
incinerate or disassemble the battery.