LIFEPULSE 10 Models LP10 and LP10B Operating Manual Oct 2007

LP10 and LP10/B

ii

QUALITY, RELIABILITY AND SAFETY This equipment has been manufactured using quality components and designed to operate safely and reliably. Huntleigh Healthcare Ltd can accept responsibility only if the following conditions are observed. 1.

The equipment is used in accordance with the instructions for use provided by Huntleigh Healthcare Ltd.

2.

The equipment is used in a building whose electrical installations conform to the standards specified by the country in which the building is situated.

3.

If the integrity of the protective earth conductor arrangement is in doubt, the equipment should be operated from its internal electrical power source.

4

All modifications and repairs to the equipment are carried out by 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 other accessories approved by HUNTLEIGH HEALTHCARE Ltd.

Your local HUNTLEIGH HEALTHCARE LTD agent is:

Manufactured by Huntleigh Healthcare Ltd, 35 Portmanmoor Road, Cardiff, CF24 5HN United Kingdom.

LP10 and LP10/B

Telephone: +44 (0)29 20485885 Fax: +44 (0)29 20492520 Email:[email protected]

iii

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.

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.

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

When several equipments 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.

LP10 and LP10/B

iv

PORTABLE SINGLE TRACE CARDIAC MONITOR LIFEPULSE 10 OPERATING MANUAL CONTENTS 1.

INTRODUCTION... 1-1

1.1 FRONT PANEL ... 1-1 1.2 FRONT PANEL OPERATED CONTROLS ... 1-1 1.2.1 Monitor Section ... 1-1 1.2.2 Rear Panel Controls... 1-2 2.

PRELIMINARY CHECKS ... 2-1

2.1 2.2 2.3 2.4

INSTALLATION ... 2-1 LINE POWER OPERATION ... 2-1 FUSES ... 2-1 BATTERY OPERATION (LP10/B) ... 2-1

3.

TECHNICAL SPECIFICATION... 3-1

4.

OPERATING INSTRUCTIONS... 4-1

4.1 USING THE LIFEPULSE 10 CARDIAC MONITOR ... 4-1 4.2 ECG MONITORING... 4-2 4.2.1 Heart Rate Indication ... 4-3 4.2.2 Pacemaker indication... 4-3 4.2.3 Warning Messages ... 4-3 4.2.4 Battery State ... 4-3 4.3 REAR PANEL CONTROLS ... 4-3 4.3.1 QRS bleep on/off and volume... 4-3 4.3.2 Brilliance... 4-3 4.4 OPERATOR FIRST LINE TROUBLE SHOOTING ... 4-5 4.5 CLEANING AND MAINTENANCE BY THE USER ... 4-6 4.5.1 Cleaning ... 4-6 4.5.2 Battery (LP10/B only)... 4-6 4.5.3 Further Maintenance... 4-6 5.

RECOMMENDED SPARE PARTS ... 5-1

5.1 ELECTRONIC AND ELECTRO-MECHANICAL SPARES ... 5-1 5.1.1 Ordering Spare Parts ... 5-1 6.

EQUIPMENT CHANGES... 6-1

7.

WARRANTY ... 7-1

LP10 and LP10/B

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LP10 and LP10/B

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1. INTRODUCTION The LifePulse 10 is a portable lightweight single trace cardiac monitor, powered directly from the mains supply or by the optional built in rechargeable battery pack (LP10/B). The monitor provides display of heart rate, QRS indication, low and high heart rate alarm levels, lead selected and trace size displayed on the tube face. Pacemaker and lead off indication will be displayed if the appropriate condition occurs. Protection is provided to prevent patient burning when this equipment is used with high frequency surgical equipment. The patient input is fully isolated, ECG pickup is obtained via conventional electrodes and a standard 3 way patient cable, or optional 5 way patient cable (LP10/5L).

1.1 Front Panel

LifePulse

~

CHG LOW BAT

1mV

SIZE

ECG LEAD

LO

HI

ON STBY

1.2 Front Panel Operated Controls 1.2.1 Monitor Section

1mV

(1mV calibration pulse

SIZE

(3 position amplitude

LEAD

(3 way lead selector or optional 5 lead selector (ECG waveform freeze

LO

LP10 and LP10/B

(Set low alarm levels

1-1

(Set high alarm levels

HI

(Alarms on/off (Unit on/standby

ON STBY

Front panel indicators

~

~

Green “ ” ON Indicates mains power connected. Yellow “CHG” ON Indicates that the internal battery is charging. Red “LOW BAT” ON Indicates the internal battery is LOW and requires charging.

CHG LOW BAT

1.2.2 Rear Panel Controls MODEL NO. SERIAL NO.

INPUT RATING POWER 50VA 40VA FREQ. 50/60 Hz SUPPLY 115/ 220- 240V ~

POWER ON

I O

MANUFACTURED IN ENGLAND BY HME LTD. Manufactured By Huntleigh Healthcare Ltd

THIS EQUIPMENT CONNECTED FOR USE ON :V

SYSTEM CONNECTOR OFF

OFF

DANGER HIGH VOLTAGE DISCONNECT POWER BEFORE REMOVING CASE FUSES 115V - T500mA 220V - T250mA 240V TYPE IEC 127 20mm x 5mm

DEFIB SYNC CONNECTOR

I O

LP10 and LP10/B

(Brilliance (QRS bleep on/off, volume (Mains power ON I / OFF 0

1-2

2. PRELIMINARY CHECKS 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 prior to installation. 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 degrees C, and relative humidity of 0 -99% (noncondensing).

2.1 Installation LifePulse monitors are supplied with a 3 core plug-in mains lead, which must be fitted with a corresponding 3 pin mains plug. The cores are coloured in the European colour code Brown Live Blue Neutral Green/Yellow Earth Fit the mains plug to the cable taking 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 5 amp fuse should be fitted.

2.2 Line Power Operation Check that the factory set voltage setting (see input rating panel on rear of unit) matches the local mains power supply. If this needs to be changed the unit has an internal voltage selector switch which can be adjusted for either 115 Volts or 230 Volts (for 240V set the selector to 230V). Connect the equipotential earth terminal to a potential equalisation conductor where provided or mandatory. Connect the power cable to the line power socket.

2.3 Fuses Fuses are fitted in both the power live and neutral lines. The correctly rated fuses for the operating voltage selected must be fitted. Type IEC 127 20mm x 5mm 115V T.500mA 220V- 240V T.250mA

250V 250V

2.4 Battery Operation (LP10/B) A fully charged battery provides approximately 2 hours continuous use. A low battery indicator light illuminates when battery power is low (sufficient power for 15 minutes operation). The battery is charged when the LP10/B is connected to the mains and the main power switch (back panel) is in the ‘ON’ position.

LP10 and LP10/B

2-1

3. Technical Specification 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. This equipment is defibrillator 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 or WITH OXYGEN OR NITROUS OXIDE

General Supply voltage

115 or 220-240V

Power input

40VA

Screen

80mm x 100mm non-fade CRT display

Sensitivity

Selectable .5, 1 and 2cm/mV. Sensitivity selected indicated on tube face.

1mV calibration

By pressing and releasing the calibration button a 1mV step is displayed.

Trace speed

25mm per second

Freeze

Front panel button freezes trace, QRS indication and heart rate display remain active.

Lead selector

Leads I, II and III, and aVR, aVL, aVF, V, STD with 5 lead option (LP10/5L). Lead selected is displayed on tube face.

Lead off indicator

Lead off or electrode fault indicated on tube face by flashing "lead off", and if the alarms are enabled, an intermittent audible tone.

Pacemaker

Indication on tube face "P". Pacemaker pulses suppressed from heart rate counter and reconstituted as negative spike (2cm amplitude) on ECG waveform.

Heart rate display

The heart rate is digitally displayed on the tube face. Range 15 - 250 BPM.

Accuracy

±1% ±1 digit

QRS indicator

Visual indication on tube face with audible bleep (volume adjustment and audio on/off switch on rear panel)

Heart rate alarm

The low and high alarm levels selected are displayed on the tube face. Low range 30 to 100 BPM High range 60 to 250 BPM

LP10 and LP10/B

50/60Hz.

3-1

Asystole alarm

If within 4 seconds of last R wave no further R wave is detected, "asystole" will be displayed on the tube face. If alarms are selected a continuous bleep will sound. Normal rhythm cancels asystole alarm.

Input impedance

Greater than 20M Ohm per lead

Frequency response

0.1 to 30Hz

Patient input leakage current

Less than 10uA at 240V 50Hz

Battery (LP10/B)

Rechargeable. With mains power connected and mains switch in on position battery is being charged. From a fully charged battery the unit will run for approximately 2 hours. When the battery low indicator is illuminated approximately 15 minutes monitoring remains. Battery recharge time 14 hours.

Outputs

All standard outputs are available from the optional rear mounted 25 way "D" connector. Separate socket for defibrillator synchronisation.

Equipotential earth

Terminal fitted to rear panel.

Electro-surgery immunity

The input is protected and screened against RF interference from electrosurgery equipment. The ECG trace is normally interference free. NOTE Severe RF levels and bad electrode placement may cause trace disturbance.

Defibrillator protection

The input is protected against defibrillation.

Size

192mm (7.6 inches) wide 155mm (6.1 inches) high, 262mm (10.3 inches) deep.

Weight

3.6Kg (7.9 lbs), 4.5Kg (10.lbs) with battery fitted.

Environmental Operating Temperature range Relative Humidity Pressure Storage Temperature range Relative Humidity Pressure

LP10 and LP10/B

10°C - 40°C 30% - 90% (non condensing) 860mb - 1060mb -10°C - 50°C 0% - 99% (non condensing) 860mb - 1060mb

3-2

Equipment Markings and Classification

The following is an explanation of the markings that may be found on the equipment. Signifies the presence of high voltages during use. Type CF equipment, and the inputs are protected against defibrillation damage. Off (power disconnected from supply)

I

On (power connected to supply) Protective earth (ground) Equipotentiality

~

Alternating current Attention - Consult accompanying documents

Standard Accessories

Mains input lead UK Mains input lead Continental 3 way patient cable (complete with fly leads with pinch clip ends) 5.way patient cable (LP10/5L only) Complete with electrodes Operators manual

XC0019 XC0015 XC0033 XC0007 745309-2

General Accessories

Rechargeable battery pack (LP10/B only) Rechargeable battery pack including fixing hardware Maintenance Manual Patient cable - no fly leads Fly lead press stud end - red Fly lead press stud end - green Fly lead press stud end - yellow Fly lead press stud end - black Fly lead press stud end - white Fly lead pinch clip end - red Fly lead pinch clip end - green Fly lead pinch clip end - yellow Fly lead pinch clip end - black Fly lead pinch clip end - white Adult single use pre-gelled electrodes Paediatric single use pre-gelled electrodes

LP10 and LP10/B

810 034 010 360 910 008 XC0041 XC0027 XC0028 XC0029 XC0030 XC0031 XC0036 XC0037 XC0038 XC0039 XC0040 EA0001 EA0002

3-3

Defibrillator Sync Connector

Socket: 5 way DIN 45322 socket (60 degree type) Pin 1 2 3 4 5

Function Sync in QRS out 0V common ECG out 0V common

Level 0-5V (>5mS) 8V (180mS) 0V 1V/mV 0V

(Max) (0-12V) (+12V) (0V) (+5V) (0V)

The sync socket conforms to the following pin view connection. 0V EC 0V

4

3

5

2

QR S Sync

1

System Connector (optional)

25 Way "D" Type 1 2 3 4 5 7 9 10 11 12 19 20 21 22 25

Description Digital GND TxD RxD RTS CTS Digital GND * Gamma camera sync (Option) Analogue GND Delayed ECG ECG Heart Rate ALM off QRS ALM alarm Unit on

Signal Level

(Max)

+8V +8V +8V +8V 0V +5V

(+12V) (+12V) (+12V) (+12V) (0V)

0V +/- 4V 1V/mV 2V/100 BPM Active low Active high +8V Active low Active high +5V

(0V) (+5V) (+5V) (+15V) (+10V) (+15V) (+5V)

NOTE: System Connector, Defibrillator Sync Socket Connection should be made only to equipment tested to comply with BS5724 Part I or equivalent. The LifePulse 10 must be separately earthed.

LP10 and LP10/B

3-4

4. OPERATING INSTRUCTIONS 4.1 Using the LifePulse 10 Cardiac Monitor Power supply - connect unit to local mains supply using the mains input lead supplied. Switch rear mounted I-O (on/off) switch to I (on). The green ~ LED on the front panel will now be illuminated. The LifePulse LP10/B is fitted with a rechargeable battery pack. If this pack is fitted then the amber, CHG, LED on the front panel will be illuminated showing battery pack is charging. Once the above conditions are met, the unit is ready for use. Switch on - depress on/standby button on front panel to switch unit on. When on the adjacent amber LED will be illuminated, a short bleep will be heard and a trace will appear on the tube within 10 seconds. Certain default or initial control settings are displayed on the tube. They are as follows: Lead Selected Sensitivity Alarm condition

Lead 1 1cm/mV Off

The above initial settings can now be altered if desired by using the following controls. With the exception of 1mV cal button, a short bleep indicates changed function when control button is depressed. Lead selection

LEAD

Sensitivity

SIZE Calibration

1mV Alarms

- By depressing the "lead" push button the lead selected for monitoring the ECG will change to Lead II. Further operations of this push button will select the leads available and the standardise position. When standardise is selected, all alarms are inoperative. Note When the 3 way patient cable (Part No. XC0033) is used, only Leads I, II, III and STD are available. When the 5 way patient cable (Part No. XC0007) is connected, Leads I, II, III, avR, avL, avf, V and STD are available. By depressing the sensitivity push button the sensitivity will change to 2cm/mV. Depressing this button again will give a sensitivity of 1/2cm/mV. Further operation of this button will select 1cm/mV again. 1mV

Should a cal signal be required, pressing and releasing the control will display a 1mV step. For clarity of measurement the lead button can be pressed to reach the standardise position

button will activate the If alarms are required, depressing the alarms and display pre-set limits on the tube face. Low heart rate alarm level : 50 High heart rate alarm level : 150 If alternative alarm levels are desired they may be changed as follows. LO

Continuous pressure on the button will decrease the low alarm limit. Once the required level is reached, remove pressure

LP10 and LP10/B

4-1

from the button. The low alarm limit can be raised by carrying out the same operation on the

LO

button. Identical operations can be

HI

high alarm limits until both the low and carried out on the high alarm levels are set to the values required. If alarms are no longer required, they can be de-activated by re depressing the button. alarm off indicator " Freeze

The pre-set limits will be removed and " will be displayed on the tube.

By depressing the button the ECG trace is frozen. The QRS indicator and heart rate are not affected. Press

again to un “freeze” the trace.

4.2 ECG Monitoring Apply appropriate electrodes to patient as shown below, and attach to either 3 way patient cable (Part No. XC0033) or 5 way patient cable (Part No. XC0007). Connect input plug to ECG input socket on front panel. ECG electrode application - There are several acceptable arrangements for positioning ECG electrodes. Optimum sites may vary with the patient's particular physiological characteristics and conditions. In most cases, ECG signal deficiencies may be improved by repositioning one or more of the electrodes. For the best monitoring results, chest placement of the electrodes is preferred because there are fewer skeletal muscles to cause artefact. Fig. 1 shows typical electrode positions for 3 lead ECG monitoring (Leads I, II, III).

RA

LA

LL

Fig 1 Under certain conditions it may be preferred to place the electrodes on the limbs. This electrode configuration would normally be used only on a short term basis or to monitor an anaesthetised patient during surgery. It is not recommended for continuous long term monitoring because of excessive muscle artefact caused by movement of the limbs. Use the following steps to apply ECG electrodes:

LP10 and LP10/B

4-2

1. 2.

3. 4. 5. 6.

If necessary, shave the area where the electrode is to be placed. The skin should be abraded slightly with a gauze pad or, alternatively, commercially available electrode preparation solutions may be used in place of abrasion. Clean the area with an alcohol pad to remove all abrading residues and baby oils (not necessary with prep solutions). Dry the skin. Snap the ECG lead wire to the electrodes prior to placement on the patient's chest. If reusable or non-gelled electrodes are used, apply gel to the electrodes. If pre-gelled disposable electrodes are used, peel the backing from the electrode adhesive and apply the electrodes.

4.2.1 Heart Rate Indication The patient's heart rate will be displayed between the low and high alarm levels. Each QRS detected will cause a ♥ to be seen adjacent to the heart rate display.

4.2.2 Pacemaker indication If the patient connected to the LifePulse 10 Cardiac Monitor is fitted with a pacemaker which is working, the ECG display will show a 2cm negative spike superimposed on the ECG waveform. The symbol adjacent to the heart rate display will change to a letter "P" for each pacemaker pulse detected.

4.2.3 Warning Messages MESSAGE

CAUSE

LEAD OFF

A lead has fallen off, is faulty or has bad contact.

INOP

Generally as a result of a defibrillator discharge the monitor electronics may be briefly saturated and the trace is unreliable until the message disappears, usually after a few seconds. Alternatively if the warning persists it may be caused by an incorrect type of electrode or a faulty lead or connection.

ASYSTOLE

No heart activity is detected.

4.2.4 Battery State When the unit is fitted with its rechargeable battery pack and both mains power “~“ (green indicator) and "CHG" (amber indicator) are illuminated, the battery is being charged. If no mains is applied the unit will automatically run from the battery pack. From a fully charged battery the unit will run for approximately 2.0 hours,. When approximately 15 minutes of battery life remains the "low" (red indicator) will be illuminated. When the mains is restored the battery will be charged and the red indicator will be extinguished.

4.3 Rear Panel Controls 4.3.1 QRS bleep on/off and volume Turning this control clockwise the audible QRS bleep is turned on, further clockwise rotation will increase the volume of the bleep 4.3.2 Brilliance

LP10 and LP10/B

4-3

Should the brilliance of the display require changing, clockwise rotation of the control will increase brilliance and anti-clockwise rotation will decrease brilliance. In order to prolong the life of the tube display the brilliance level should be set to give a clear trace without being too bright.

LP10 and LP10/B

4-4

4.4 Operator First Line Trouble Shooting This section gives some of the more common problems encountered during use and possible causes. If the operator cannot locate the problem after consulting the tables in this section, the monitor should be switched off, disconnected from mains power source and a qualified technician should be consulted. Before attempting trouble shooting verify that the power cable is properly connected to both the monitor and mains power source.

SYMPTOM

POSSIBLE CAUSE 1.

Power cable not connected to live power source

2.

Rear panel AC power switch in OFF position

3.

Defective power cable

4.

Mains input fuses blown

Amber unit "ON" indicator not illuminated

1.

Unit not switched on

Green power indicator and amber unit "ON" indicator illuminated but no display present

1.

Rear panel brilliance control set too low

No signal on trace

1.

Defective patient cable

1.

Electrode site not properly prepared

2.

Poor electrode contact

3.

Defective patient cable

No heart rate display or flashing heart symbol

1.

Patient electrodes incorrectly sited. Try repositioning the electrodes

No QRS bleep

1.

Switch on rear panel in OFF position or volume set too low

No alarm digits displayed

1.

Alarms switched off

Continuous alarm indications. No ECG signal on display ("lead off" displayed)

1.

Defective patient cable

2.

Electrode or lead off

Green power indicator not illuminated

Excessively noisy trace

LP10 and LP10/B

4-5

4.5 Cleaning and Maintenance by the User 4.5.1 Cleaning The unit and patient lead should be kept clean and free from electrode gel. It is recommended that they are wiped clean with a cloth or tissue dampened with water and detergent. Repeated cleaning with hot water and detergent should remove even heavy soiling. Do not autoclave the unit or patient cable. Cleaning (weekly)

The unit and power lead should be kept clean and checked for signs of damage. It is recommended that they be wiped clean with a cloth or tissue dampened with water and detergent. Check mains power connections weekly and examine outer sheath of power lead for signs of damage. Note

Electrical connectors must not be immersed in any fluid.

4.5.2 Battery (LP10/B only) If the unit is not in constant use the state of battery charge should be checked periodically and recharged if necessary. Recharging a flat battery will take approximately 14 hours and is achieved by connecting the unit to the mains power and switching the rear power switch to I (on). Observe that the green

~ indicator and amber "CHG" are illuminated.

Note: The monitor does not have to be in operation for battery charging.

4.5.3 Further Maintenance HUNTLEIGH HEALTHCARE LTD recommend that preventative maintenance checks are carried out on the unit 6 monthly under a HUNTLEIGH HEALTHCARE LTD Service Contract. Alternatively, the maintenance may be carried out by suitably qualified personnel. Details of the procedure are provided in the maintenance manual (available as an optional accessory as part no 910 008). Further technical information is available from Huntleigh Healthcare Ltd upon request.

LP10 and LP10/B

4-6

5. Recommended Spare Parts 5.1 Electronic and Electro-Mechanical Spares Certain items have a long shelf life but a limited life in use. Items in this category are mains power leads, patient input cables, which are subject to physical damage in use, and fuses.

5.1.1 Ordering Spare Parts Due to developments improving the product, over the years certain spare parts may not be readily interchangeable between early and late production units. Always quote the serial number of the unit and date of purchase, if known. This information is in addition to the circuit reference and the reference number and issue of the PCB required. Items returned for replacement under guarantee should be labelled with the unit type, serial number, date of purchase, if known, and written details of the symptoms or fault found. Orders for spare parts may be sent by post, telex, fax or telephoned to HUNTLEIGH HEALTHCARE LTD or approved agents or distributors. Spare Parts Recommended as Essential

Number of units to be maintained Patient cable 3 way Flying leads – red/yellow & green (Pinch clip) Mains lead UK Mains lead Continental

Stock No XC0041 ACC-VSM-06

1 1 1

5 2 2

10 3 3

248502/UK-3 248502/EUR-3

1 1

2 2

3 3

1 -

5 1 1 1 1 1 1

10 2 1 1 2 2 2

Spare Parts Recommended as Desirable

Number of units to be maintained Battery pack (LP10/B only) Mains switch Cathode ray tube Processor assembly ECG amplifier assembly CRT interface assembly

LP10 and LP10/B

Stock No ACC-VSM-155 LR0021 DC0003 010-321 010-323 010-322

5-1