Huntleigh LP110-S User manual

ENGLISH
LP110/LP110-S
Trigger Monitor
Instructions for Use
Medical Devices Directive 93/42/EEC
as amended by 2007/47/EC
Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development
programme the company reserves the right to modify specifications and materials of the
Lifepulse range without notice.
Lifepulse and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2009.
© Huntleigh Healthcare Ltd. 2009
Manufactured by Huntleigh Healthcare Ltd for CANON Medical Systems.

2
Table of Contents
Contents
1. Quality, Reliability & Safety ...............................................4
1.1 Cautions..................................................................................................4
2. Introduction........................................................................7
2.1 Intended Use ..........................................................................................7
2.2 Preliminary Checks................................................................................8
2.2.1 Installation .............................................................................................................. 8
2.2.2 Line Power Operation............................................................................................. 8
2.2.3 Battery Operation and Low Battery Alarm (LP110 only)......................................... 9
2.2.4 Fuses...................................................................................................................... 9
2.3 Front Panel Controls and Indicators....................................................9
2.4 Rear Panel Features ..............................................................................10
2.4.1 External Pin Out Connections ................................................................................ 10
2.5 Patient Inputs ........................................................................................11
2.6 Display ...................................................................................................12
2.7 Alarms.....................................................................................................12
3. Specifications ....................................................................13
3.1 Equipment Classification .....................................................................13
3.2 Environmental........................................................................................13
3.3 General ...................................................................................................14
3.4 ECG Monitoring Functions ...................................................................14
3.5 Accessories ...........................................................................................15
3.6 Equipment Markings .............................................................................16
4. Operation ...........................................................................17
4.1 General ...................................................................................................17
4.1.1 Switching On ......................................................................................................... 17
4.1.2 Displays.................................................................................................................. 17
4.1.3 Menu ...................................................................................................................... 18
4.1.4 Start / Stop / Clear Counter.................................................................................... 19
4.1.5 Pause ..................................................................................................................... 20
4.1.6 Size ........................................................................................................................ 20
4.1.7 Lead ....................................................................................................................... 20
4.2 ECG Monitoring......................................................................................20
4.2.1 Patient Preparation................................................................................................. 21
4.2.2 ECG SETUP........................................................................................................... 21
4.2.3 Starting the HR counter.......................................................................................... 21
4.2.4 PAUSING the ECG waveform ................................................................................ 22
4.2.5 Adjusting the ECG waveform amplitude................................................................. 22
4.2.6 Adjusting the Lead selection .................................................................................. 22
4.2.7 Locking and unlocking the touch screen ................................................................ 22
4.2.8 Pacer ID .................................................................................................................22
4.3 Synchronised Output ............................................................................23
4.3.1 Synch Pulse ID....................................................................................................... 23
4.4 ECG Simulator........................................................................................24

3
Table of Contents
5. Trouble Shooting ................................................................25
6. Maintenance.......................................................................26
6.1 Care of your Equipment........................................................................26
6.2 Cleaning and Disinfecting.....................................................................27
6.3 Further Maintenance..............................................................................27
7. Warranty & Service............................................................28

4
1. Quality, Reliability & Safety
Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, display features and operating
techniques. Ensure each user fully understands the safety and operation
of the unit, as mis-use may cause damage to the unit or injury to the user
or the patient.
This equipment has been manufactured using quality components and
designed to operate safely and reliably.
If the integrity of the protective earth conductor is in doubt, the equipment
should be operated from its internal electrical power source.
All modifications and repairs to the equipment must carried out by qualified
service engineers, agents or hospital technicians authorised by Huntleigh
Healthcare Ltd.
CE MARKING
This equipment carries a CE mark but this is only fully valid if it is used in
conjunction with cables and accessories approved by Huntleigh Healthcare Ltd.
1.1 Cautions
Note The following are descriptions of general hazards and unsafe
practices that could result in death, severe injury or product
damage. Specific warnings and cautions not appearing in
this section are found throughout the manual.
Possible Fire
or Explosion A possible explosion hazard exists if used in the presence of flammable anaesthetics. Explosion or fire can result.
Possible
Safety
Hazard
Do not mount the equipment directly above the patient.
Place the equipment in a location where it cannot harm the
patient should it fall from its shelf or other mount.
Possible
Electrical
Hazard
Do not operate the equipment using damaged cables and
wires, or loose snap fittings, which may cause interference or
loss of signal.
Perform frequent electrical and visual inspections on cables
and wires.
Possible
Shock or
Fire Hazard
Do not immerse any portion of the instrument in water. Fluid
spills may damage the instrument’s electrical components.
Quality, Reliability & Safety

5
Quality, Reliability & Safety
Possible
Equipment
Damage
Do not sterilise this product. Sterilisation environments can
cause severe damage.
Do not autoclave or gas sterilise accessories unless
manufacturer instructions clearly approve it.
The unit is equipped with a touchscreen designed to be
operated by fingertouch. Do not use sharp instruments to
operate.
Possible
Safety Risk Do not substitute accessories. Use only recommended accessories listed in this manual. Substitution may cause
the instrument to work improperly. The correct accessories
are shielded to prevent conductive parts of the electrodes
contacting other conductive parts or earth. No action should
be taken which permits this to happen.
Warning All interconnecting equipment must meet their relevant
safety standards i.e. EN60601-1. When several pieces
of equipment of various origins are interconnected, the
summation of leakage currents may constitute a hazard.
Warning The accuracy of the readings obtained from this equipment
may be affected by the presence of a pacemaker or by
cardiac arrhythmia
Warning If it is thought that interference is occurring from or with other
equipment, such as that used for Diathermy, then either shut-
off, or move, the offending devices, increase the separation
or reduce lead lengths.
Caution Electromagnetic Compatibility (EMC). This product complies
with the requirements of applicable EMC Standards. The use
of accessories not specified by the manufacturer may result
in increased emissions by, or decreased immunity of, the
equipment, affecting its performance.

6
Quality, Reliability & Safety
Do not use this equipment in the presence of flammable gases.
Do not immerse any part of the equipment in any liquids.
Do not use solvent cleaner on any part of the system.
Do not use high temperature sterilising or E-beam / gamma sterilisation
processes.
If any doubt exists concerning the use of this equipment, an alternative
method should be used.
This product contains sensitive electronics; strong radio
frequency fields could interfere with the operation of the system.
In the event where this occurs, we suggest that the source of
interference is identified and the equipment is used ‘out of range’.

7
2. Introduction
The LP110/LP110-S is a compact Trigger monitor which provides the user with
a single or dual channel presentation of the patients ECG complex.
The monitor is of fully moulded construction in a tough flame retardant ABS
material.
The liquid crystal display (LCD), with touch screen, provides a clear
presentation of patient information.
All controls, with the exception of the front panel ON/OFF switch, are software-
controlled.
The LP110 series weighs 2.7Kg, and may be powered from an AC mains supply
or from the integral rechargeable battery pack.
The LP110-S series weighs 2.0Kg and is powered from an AC mains supply
only.
An optional mounting plate can be fitted to the underside of the LP110/LP110-S
to enable the monitor to be mounted on a wall bracket, stand or gantry.
Introduction
2.1 Intended Use
The LifePulse LP110/LP110-S monitor is intended to monitor the ECG cardiac
output of adult and pediatric patients. It provides a display of the ECG waveform
and heart rate. It can also be configured to display the maximum and minimum
recorded heart rate.
It is intended to be used in conjunction with a CT scanner and powered from a
mains supply.

8
Introduction
2.2 Preliminary Checks
Contents (supplied with each system)
Item
1 x LP110 / LP110-S Lifepulse Trigger Monitor
1 x ECG Trunk Cable with 900mm chest leads
1 x Trigger Interface cable (10M)
1 x Pack of 30 Adult Ag/AgCL electrodes
1 x Instructions for Use 1 x NUPREP Skin preparation gel (114g)
Delivery Inspection
Huntleigh Healthcare Ltd takes every precaution to ensure that their goods
reach you in perfect condition. However, accidental damage can occur in transit
and storage. For this reason we recommend that a thorough visual inspection
is made immediately the unit is received. Should any damage be evident or any
parts missing, ensure that Huntleigh Healthcare Ltd is informed at once.
Storage
Should the unit not be required for immediate use, it should be re-sealed in
its original packing, after carrying out the initial delivery inspection, and stored
under covered conditions at a temperature between -10 and 50 °C, and relative
humidity of 0-99% (non-condensing)
2.2.1 Installation
LP110/LP110-S monitors are supplied with a plug-in mains lead, fitted with a 3
pin mains plug. The cores use the European colour code :
BROWN LIVE
BLUE NEUTRAL
GREEN/YELLOW EARTH
If it becomes necessary to fit a new mains plug take care that the wires have
correct lengths, so that in the event of extreme strain, the earth wire will be the
last to break. Make sure that the cable clamp secures the outer sheathing so
that there is no direct strain on any individual wires at the terminals.
Where the plug is fused, a 5A fuse should be fitted.
2.2.2 Line Power Operation
No alterations are required to change between 100 and 240 Volt operation.
Connect the equipotential earth terminal to a potential equalisation conductor
where provided. Connect the power cable to the line power socket.
Note: To isolate the LP110/LP110-S from the mains or line supply, disconnect
the power cable from the mains inlet at the rear of the unit

9
Introduction
2.3 Front Panel Controls and Indicators
1~Green “~ “ ON Indicates mains power connected.
2 CHG Yellow “CHG” ON Indicates that the internal battery is charging.*
3Yellow above the “On” / Off” button indicates the unit is switched
on.
3
1
2
2.2.4 Fuses
Fuses are fitted in both the live and neutral lines. Correctly rated fuses must be
fitted as below:-
T2AH 250VAC
2.2.3 Battery Operation and Low Battery Alarm
(LP110 only)
The battery, when fully charged will provide approximately 6 hours continuous
use. An on-screen battery indicator shows the state of charge at all times.
Battery charging takes place whenever the monitor is connected to the mains.
When the battery is discharging two flashing arrows >> point away from the
battery symbol. When the battery is charging two flashing arrows << point
towards the symbol. If the battery charge drops below 15% the indicator will
change colour to red and an alarm will sound.
It is recommended to connect the monitor to a mains supply for 12 hours prior to
first use or after prolonged storage to ensure the battery is fully charged.
* LP110 Only

10
Introduction
2.4 Rear Panel Features
1Mains Input Socket
2I/O Sockets (from the top) : • RS232,Trigger O/P, ECG O/P • External Monitor Socket
• Equipotential Earth Connector
3Integral Battery Access Cover
4Serial Number Label
5Rating Label
1
2
3
4
2.4.1 External Pin Out Connections
Note: External connections are to be made to IEC60601-1 compliant
equipment only.
VGA Monitor Connection
Pin No. Description
1 Red
2 Green
3 Blue
4, 5, 6, 7, 8, 10, 11, 12 GND
13 H SYNC
14 V SYNC
5

11
Introduction
25 Way ‘D’ Type Socket
Pin No. Description
1, 7 GND
9 sync pulse output
12 ECG output 1V/mV
2.5 Patient Inputs
All patient inputs are fully isolated from electrical earth. ECG rate is achieved
via conventional electrodes and a 3 way patient cable.
The side panel of the LP110/LP110-S has the patient input connector (1).
1ECG Input
The LP110/LP110-S is supplied with an integrated ECG Simulator (2,3,4).
This should only be used to verify system integrity (patient cable and system
connections). The simulator is software controlled.
The terminals located on the right hand side of the monitor are colour coded
according to AHA and IEC protocol.
2Simulator Output (R)
3Simulator Output (L)
4Simulator Output (F)
1
2
3
4

12
Introducion
2.6 Display
The display comprises a waveform for ECG, either single or dual trace.
10:40 23/03/10
25 mm/s
I6184
48
I
85 %*
P
X2
X2
The readouts are displayed as follows:
Lifesign Trace Description
ECG The trace is displayed either as a single or cascaded trace. The
HR is presented as a large numeric display in the central area of
the screen. Also displayed is the selected lead and gain setting.
2.7 Alarms
Alarm Description
LEAD OFF LEAD OFF message displayed if any ECG chest lead is
disconnected from patient.
ASYSTOLE If within 10 seconds of last R Wave no further R Wave is
detected, ‘ASYSTOLE’ will be displayed.
LOW
BATTERY*
If the battery capacity falls to 15%, the battery symbol
changes colour to red & and an audible alarm sounds.
* Battery
Status
Lead ID
CAL
Pulse HR Time & Date
Max/Min
Counter
Menu
Size
(Gain) Lead
Start/Stop/Clear
counter (when
enabled)
Freeze
Waveform Touchscreen
Lock
Cascaded
Waveform
(Setup
Option)
Pacer
* LP110 Only

13
Specifications
3. Specifications
3.1 Equipment Classification
Type of protection
against electric shock. Class 1 and Internally powered equipment
Degree of
protection
against electric
shock
Type CF - equipment with an applied part, intended for
direct electrical connection to the heart. The equipment
is defibrillation discharge protected.
Mode of operation. Continuous
Degree of protection
against harmful ingress
of water.
IPX0
Degree of safety of
application in the
presence of a flammable
anaesthetic
Equipment not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR,
OXYGEN OR NITROUS OXIDE
Electrosurgery Surgical
Equipment This unit does not provide protection against HF burning from other surgical equipment.
Complies with
LP110-S Only
Medical
Electrical
Equipment
25EA
IEC 60601-1:1988/A2:1995, EN 60601-1:1990/A2:1995,
UL 60601-1 1st Edition, CAN/CSA C22.2 No. 601.1-M90
IEC 60601-2-27 2nd Edition 2005 excluding Section 8
‘ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT’
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY, IN ACCORDANCE
WITH UL60601-1, CAN/CSA C22.2 No 601.1
3.2 Environmental
Operating Storage
10°C to 40°C Temperature range -10°C to 50°C
15% to 90% (non condensing) Relative Humidity 0% to 99% (non condensing)
860mb to 1060mb Pressure 860mb to 1060mb

14
Specifications
3.3 General
Supply voltage 100 to 240V 50/60Hz.
Fuse Type T2AH 250VAC
Power input 55 VA
Screen 8.4 inch diagonal high brightness TFT SVGA flat panel display
Trace speed 25mm / 50mm per second.
Battery
(LP110 Only) 12V 4.5Ah NiMH type with smart charger and fuel gauge type indication of battery status. Approximately 6 hours of continuous
monitoring is available from a fully charged battery.
A fully discharged battery will take approximately 4 hours to
recharge to 90% capacity.
Size 240mm wide, 223mm high (including feet), 160mm deep (including
equipotential earth connector)
Weight 2.7Kg (LP110) 2.0Kg (LP110-S)
3.4 ECG Monitoring Functions
Heart Rate range 15 – 260 BPM ±1% ±1 digit
Selectable leads I, II, or III
Selectable display
gain 0.5, 1, 2 or 4.
Lead fault detection Displays LEAD OFF warning for any of the leads.
QRS indication Flashing heart symbol. Audible tone with volume control off
Synch ID Trigger mark on ECG Complex
Esis/defibrillator
protection Yes
Bandwidth 3Hz - 25Hz (Filter ON)
0.5 – 45Hz (Filter OFF)
Filter 50Hz and 60Hz notch (automatic)
Input impedance > 20MΩat 10Hz
CMMR >90db
Lead off sensing
current 100nA
Active Leg Drive
Current < 2μA
Pacemaker
indication ‘P’ symbol appears in place of ‘Heart’ symbol and the trace displays a vertical marker.
Pacer Pulse
Rejection Width: 0.1 to 2ms at ±2 to ±700mV Overshoot: <120ms
Alarms ‘Lead Off’ and ‘Asystole’ alarms

15
Specifications
3.5 Accessories
Item Part No.
ECG Electrodes - box 300 ACC-OBS-027
3 Way IEC Patient Cable (complete with 900mm chest leads) ACC-VSM-213
Chest Leads - 600mm (IEC) ACC-VSM-214
Chest Leads - 900mm (IEC) ACC-VSM-215
3 Way Trunk ACC-VSM-216
Fixing Kit (a) ACC-VSM-152
Mobile cart with intergrated storage basket (b) ACC-VSM-153
Table Pedestal (c) ACC-VSM-212
Trigger Interface Cable (5M) ACC-VSM-217
Trigger Interface Cable (10M) ACC-VSM-218
Trigger Interface Cable (15M) ACC-VSM-219
Multi Lingual Instructions for Use ACC-VSM-220
NUPREP Skin preparation gel (3 x 114g) ACC-VSM-242
(a) + (b) - Items must be purchased together
(a) + (c) - Items must be purchased together

16
Specifications
3.6 Equipment Markings
The following is an explanation of the equipment markings and classification as
defined in BS5724: Part 1: 1989 (IEC 601-1:1988), ISO 8790 and BS ISO/IEC
8878:1992.
Symbol Description
Type CF and the input is protected against defibrillation
damage.
On/Off
Equipotentiality
Alternating current
Attention - consult accompanying documents / Instructions
for Use
Trigger O/P, ECG O/P
Monitor
Battery
This product may be disposed of only through a
government approved collection scheme or treatment
facility. Do not dispose of in the domestic refuse. If in doubt
contact your local Huntleigh Healthcare Ltd representative.

17
Operation
4. Operation
4.1 General
4.1.1 Switching On
To switch the LP110/LP110-S ON, press the main ON / OFF button on the unit
front panel. The amber Led will illuminate followed by a short tone.
4.1.2 Displays
At switch ON, the LP110/LP110-S will carry out a system self test and display
the following welcome screen:
Version X.X
After a few seconds, the monitor will display the main application screen.
10:40 23/03/10
25 mm/s
X2
X2
I6184
48
I
85 %*
P
10:40 23/03/10
25 mm/s
X2
I
6184
48
I
85 %*
P
Single Trace Dual Trace (Cascade)

18
Operation
The LP110/LP110-S is controlled from a series of touch sensitive programmable
soft keys which are located along the bottom of the screen. Pressing these will
enable the user to access a function or sub menu level.
I
MENU START/STOP/CLEAR PAUSE SIZE LEAD
4.1.3 Menu
Pressing the MENU button will enable the user to access the following settings:
(Note : BOLD text = default setting)
ECG Display (single or dual)
Synch pulse ID (ON, OFF)
Size (1/2, 1, 2, 4)
Speed (25 / 50 mm/s)
Counter (ON / OFF)
Processing (4, 6, 8 beats)
PACER (ON/OFF)
Tone (ON, OFF)
EXIT
System Language (English, Spanish, French, Italian, German,
Flemish / Dutch, Russian),
Time (HH:MM)
Date format (DD:MM:YY / MM:DD:YY)
Brightness 1, 2, 3
EXIT
Simulator ON / OFF
Rate 30,35,40,45,50,55,60,65,70,75,80,85,90,95,100,105,
110,115,120,125,130,135,140,145,150,155,160,165,170,
175,180

19
Operation
Service (requires access code)
Application
Firmware version
Battery voltage *
Battery charge / discharge cycles *
Max run time
USB Upgrade
Calibrate TS
Filter ON
ALD ON
Reset to factory default settings (Y/N)
Exit
4.1.4 Start / Stop / Clear Counter
60 72
55
MAX
MIN
The start / stop / clear counter
softkey is only available if the
COUNTER setting is switched
ON in the ECG set up option. This
softkey is dynamic and performs
three functions.
With the feature switched ON, pressing the soft key once starts
the heart rate counter. The small digits alongside the main
HR display will automatically store the max and min heart rate
values (range).
Pressing the soft key will stop the counter.
Pressing the softkey again will clear the counter display.
* LP110 Only

20
Operation
4.1.5 Pause
X1
Pressing the PAUSE soft key will
freeze the waveform on the screen,
other background applications will
continue.
Press the PAUSE soft key again to
un-freeze the waveform
4.1.6 Size
Pressing the SIZE soft key will enable the user to change the size of the
waveform (½, 1, 2, 4) on the screen.
4.1.7 Lead
Pressing the LEAD soft key will enable the user to change the selected lead (I,
II, III) on the screen.
4.2 ECG Monitoring
GREEN
RED YELLOW
RL
F
To monitor the patient’s ECG, apply the electrodes
as shown in the diagram.
Optimum sites may vary with the patient’s individual
physiological characteristics and condition.
The best monitoring results will be obtained by
placing the electrodes on the chest.
(IEC Colour scheme shown)