Model 1500 Patient Monitor Directions for Use Sw Ver 1.0.X

ii

Welch Allyn 1500 Patient Monitor

© 2010 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, precautions, warnings, or statement of intended use published in this manual. Welch Allyn, Acuity, Smartcuf, FlexNet, and Flexible Monitoring are registered trademarks of Welch Allyn. Nellcor and Oximax are trademarks of Nellcor Puritan Bennett. NOTICE: Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use this instrument with any oximetry sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Microstream is a registered trademark of Oridion. NO IMPLIED LICENSE: Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized consumable CO2 sampling consumable products which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling consumable products Software in this product is copyrighted by Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, call the nearest Welch Allyn representative. :

USA

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Sweden

REF 103700 (CD) Manual 2.510865 Ver A, 2010-10

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www.welchallyn.com

SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland

+ 46 8 58 53 65 51

Directions for use

Contents

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Contents 1 - Safety... 1 User responsibility... 1 Intended use... 1 Organizational measures... 2 Safety... 2 Safety equipment... 3 Alarms... 3 Operation with other devices... 4 Networks and internet... 4 Maintenance... 5 Symbols... 5 Additional terms... 7

2 - Introduction... 9 Standard features... 9 Options... 9 The Welch Allyn® 1500 Patient Monitor... 10 Function buttons... 12 Setup menu overview... 13 Display overview... 14

3 - Operation... 15 Startup and initial preparation... 15 Turn the monitor on or off... 16 Power supply... 16 Inserting recorder paper... 18 Initial settings... 19 Standby mode... 20 Trend data... 21 Defining display waveforms... 22 Settings via a parameter field... 22

4 - Alarms... 23 Display of alarms... 23 Silencing an alarm... 24 Suspend all alarms... 24 Turning off an individual parameter alarm... 25 Alarm limit setting... 25 Physiological Alarms... 26

5 - Monitoring... 27 General... 27 ECG... 28 Arrhythmia... 38 Respiration rate... 40 etCO2 measurement... 42 NIBP monitoring... 46 Start a single NIBP measurement... 47 SpO2 monitoring... 50 IBP monitoring... 54 Preparing IBP measurement... 55 Temperature monitoring... 57

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Contents

Welch Allyn 1500 patient monitor

6 - Acuity Central Station... 59 Safety... 59 Introduction... 60 Connect to the Acuity Central Station... 60

7 - Maintenance... 61 Maintenance interval... 61 Visual inspection... 62 Button check... 62 Speaker check... 62 LED check... 62 Alarm check... 62 Battery maintenance... 63 Inspecting and cleaning the monitor and accessories... 64 Inspection and checklist report... 66 Replacing the fuses... 68 Troubleshooting... 69 EMC compliance... 70 Mounting on a wall or stand... 71 Recycling monitor components... 71

8 - Settings... 73 Parameter settings... 73 General and alarm settings... 74

9 - Accessories... 83 Miscellaneous... 83 Mounting... 83 Batteries... 83 Cables... 84 Nellcor SpO2... 84 ECG... 84 IBP... 84 Temperature... 85 NIBP... 85

A - Technical data... 87 System data... 87 Safety standards... 90 Measured values... 91

Index... 95

1

1 Safety User responsibility •

The numerical and graphical results and any interpretation given must be examined with respect to the overall clinical condition of the patient and the general recorded data quality.

•

The indications given by this equipment are not a substitute for regular checking of vital functions.

•

This monitor is only to be used by those trained in its operation or repair.

•

Ensure that the personnel have read and understood these operating instructions and in particular this chapter “Safety.”

•

Damaged or missing components must be replaced immediately.

•

It is the owner's responsibility that the valid regulations for safety and prevention of accidents are observed.

Intended use •

The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature and respiration of a patient.

•

The device is intended to be used by qualified doctors or trained medical personnel.

•

The device is not suitable for transport.

•

There is no danger for patients with pacemaker.

•

The device is intended for the monitoring of one patient at a time.

•

The device is not designed for sterile use nor is it designed for outdoor use.

•

Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases.

•

© The device is classified CF . It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation.

•

This product is not designed for direct cardiac application.

•

The arrhythmia module is not intended for use with neonatal patients.

•

The ST-analysis module is not intended for use with neonatal patients.

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Safety

Welch Allyn 1500 Patient Monitor

Organizational measures •

Before using the monitor, ensure that an introduction regarding the monitor functions and the safety precautions has been provided by a medical product representative..

•

Observe the operating instructions and maintenance instructions.

•

These operating instructions do not override any statutory or local regulations, or procedures for the prevention of accidents and environmental protection.

Safety WARNING Mount the monitor securely so that there is no possibility of it falling on the patient or floor. WARNING If uncertain about the accuracy of any measurement, first check the patient’s vital signs by alternate means, and then make sure the monitor is functioning correctly. WARNING Do not touch the monitor during defibrillation.

WARNING To ensure patient safety, none of the ECG electrodes including the neutral electrode, nor the patient or any person with simultaneous patient contact, must come in contact with conductive parts, even when these are earthed. WARNING Immediately report any changes that impair safety (including operating behavior) to the person responsible for servicing the monitor. WARNING Do not place any liquids on the monitor. If liquid is spilled over the monitor, immediately disconnect the monitor from the mains and dry. The monitor must be serviced before reusing. Caution This manual, and especially these safety notes, must be read and observed. Caution Electrical installation of the room or the building in which the monitor is to be used must comply with regulations specified by the country in which the equipment is to be used Caution Ensure the monitor is always mounted on a Welch Allyn approved bracket or stand. The monitor is unstable at angles greater than 5 degrees when not secured.

Directions for use

Safety

Safety equipment Operating the monitor without the correctly rated fuse, or with defective cables, constitutes a danger to patient safety. Therefore: Caution Do not operate the monitor if the ground connection is suspect or if the mains lead is damaged or suspected of being damaged. Caution Damaged cables and connections must immediately be replaced.

Caution Electrical safety devices, such as fuses, must not be modified.

Caution Blown fuses must only be replaced with the same type and rating as the original

Alarms WARNING Do not silence the audible alarm if patient safety may be compromised. WARNING Always respond immediately to an equipment alert because the patient may not be monitored during certain alarm conditions. WARNING Before each use, verify that the alarm limits are appropriate for the patient being monitored. WARNING Check the audible alarm silence duration before temporarily silencing the audible alarms.

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4

Safety

Welch Allyn 1500 Patient Monitor

Operation with other devices Caution Do not use the monitor in or near an MRI suite. •

Only use accessories and other parts recommended or supplied by Welch Allyn. Use of other than recommended or supplied parts may result in injury, inaccurate information and/or damage to the monitor.

•

Accessory equipment connected to the analogue and digital interfaces must be certified according to the respective IEC standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service department or your local representative.

•

Any other equipment used with the patient must use the same common earth as the monitor.

•

Precautions must be observed when using high frequency devices. Operating high frequency electro-surgical equipment in the vicinity of the monitor can produce interference in the monitor and cause incorrect measurements. Use patient cables recommended by Welch Allyn to avoid possible signal interference during ECG acquisition.

•

There is no danger when using the ECG monitor simultaneously with electrical stimulation equipment. However, during defibrillation, keep discharge paddles away from the monitor ECG lead wires, electrodes, any other monitor sensors, and other conductive parts in contact with the patient.

•

If the patient cable should become defective after defibrillation, a lead-off indication is displayed and an audible alarm is issued.

•

Portable communication equipment, HF two-way radios and devices marked with the symbol can affect this monitor (see “EMC compliance” on page 70).

Networks and internet •

When the monitor is part of a network, (LAN, HIS, etc.), transmitting over a telephone network or any other transmission /reception medium, or if exposed to the Internet or other networks that are not secure, appropriate security measures must be provided to protect the patient data stored.

•

Patient security and security of the network is the sole responsibility of the user.

Directions for use

Safety

5

Maintenance WARNING Danger of electric shock. Do not open the monitor case. There are no user serviceable parts inside. Servicing may only be carried out by a qualified technician authorized by Welch Allyn. WARNING Before cleaning and to isolate the mains power supply, switch the monitor off and disconnect it from the mains by removing the plug. Caution Do not use high temperature sterilization processes (such as autoclaving). Do not use E-beam or gamma radiation sterilization. Caution Do not use solvent or abrasive cleaners on either the monitor or cable assemblies. Caution Do not immerse the monitor or cable assemblies in liquid.

Symbols These symbols appear in this user guide. WARNING Warning statements in this user guide identify conditions or practices that could result in personal injury. Caution Caution statements in this user guide identify conditions or practices that could result in damage to the equipment or other property.

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Safety

Welch Allyn 1500 Patient Monitor

The following symbols appear on the monitor, or accessories. Symbol

Definition

Symbol

Definition

Potential equalization (earth ground)

©

CF symbol. This monitor is classified safe for internal and external use. However, it is only defibrillation protected when used with the original Welch Allyn patient cable!

The monitor can be recycled.

Recycle the monitor and battery separately from other waste. Refer to www.welchallyn.com/weee for collection point and additional information.

Notified body of the CE certification (TÜV P.S.).

Note accompanying documents.

Altitude limits

Humidity limits

Keep away from sunlight

Stacking limit

Temperature limits

Keep away from rain

This way up

Fragile

CO2 in

CO2 out

Temperature

NIBP

The following symbols appear on the screen. Symbol

Definition

Symbol

Definition

Alarm off

Patient mode symbols; neonate, pediatric, adult

Acuity connected

Acuity not connected

Directions for use

Safety

7

Additional terms Implied authorization Possession or purchase of this monitor does not convey any express or implied license to use the monitor with replacement parts which would alone, or in combination with this monitor, fall within the scope of one or more patents relating to this monitor.

Terms of warranty Your monitor is warranted against defects in material and manufacture for the duration of one year (from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles free replacement and labor of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorized or unqualified persons attempt to make repairs. In case of a defect, send the apparatus to your dealer or an authorized Welch Allyn service center. The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if: •

assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by the manufacturer.

•

the monitor and approved attached equipment is used in accordance with the manufacturer's instructions.

Note

There are no express or implied warranties which extend beyond the warranties hereinabove set forth. Welch Allyn makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

Note

This equipment has been tested and found to comply with the limits for a class A digital device, pursuant to both Part 15 of the FCC (Federal Communications Commission) rules and the radio interference regulations of the Canadian Department of Communications. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with this instruction user guide, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. WHEN USED IN CANADA: To prevent radio interference to the licensed service, this device is intended to be operated indoors and away from windows to provide maximum shielding. Equipment (or its transmit antenna) that is installed outdoors is subject to licensing.

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2 Introduction The monitor is designed for adult, pediatric and neonatal use. It has a 15-inch screen for comprehensive vital data monitoring. The monitor can be used with mains power (100 – 240 VAC) or with an internal battery.

Standard features •

Function buttons and trim knob for easy operation

•

15-inch color screen

•

Measuring results and trends can be printed automatically or manually

•

Vital parameters such as: •

ECG (3, 5 or 12 lead)

•

Heart rate

•

Respiration

•

SpO2

•

Invasive blood pressure

•

Temperature

•

Non Invasive Blood Pressure

Options •

Printer

•

etCO2

•

Central Station via Ethernet (Welch Allyn Acuity)

•

Resting ECG with interpretation

•

Resting ECG with interpretation and measurements

•

Arrhythmia analysis

•

ST analysis

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Introduction

Welch Allyn 1500 Patient Monitor

The Welch Allyn® 1500 Patient Monitor Front panel Visual alarm indicator

Patient connection panel

Function button panel

Trim knob

Back panel Ethernet (RJ45) connector Potential equalization (ground) Nurse call connector* Mains connector (100-240 VAC)

Printer

USB connector (lift door)

*The nurse call can be used to give an external indication of a parameter alarm.

Directions for use

Introduction

11

Connection panel Temperature 1

etCO2 sampling input SVC (service only)

etCO2 sampling exhaust

ECG

NIBP SpO2

IBP 1

IBP 2

Note

The connection panel layout will vary according to the options installed.

Patient connection panel options Two connection panels for the monitor are available depending on the options specified. The panels are as follows: SpO2 (Nellcor)

NIBP

IBP (x2)

ECG

Temp

Panel 1

•

•

•

•

•

Panel 2

•

•

•

•

•

CO2 (Oridion)

•

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Introduction

Welch Allyn 1500 Patient Monitor

Function buttons Print Printout of three waveforms and all parameters. The waveforms and print settings are defined in the Printer menu (see “Recorder” on page 75). Note that an auto printout can also be obtained when a limit is violated. This is also defined in system setup. Alarm silence Silence Icon of an audible alarm or confirmation of displayed messages. The silence icon time is defined in the Setup/Administrator menu (see “General and alarm settings” on page 74). NIBP measurement interval Interval setup for non-invasive blood pressure measurement or switch-off of the interval measurement (see “Automatic blood pressure measurement” on page 47). Saves patient data. NIBP measurement Start or stop of the non-invasive blood pressure measurement (see “Start a single NIBP measurement” on page 47). Standby In standby mode patient monitoring is interrupted and the screen is blank. Monitoring is resumed when any button is pressed. Note when the monitor is connected to Acuity, different options are given. Setup Display of the Setup menu. The required menu item can be selected by turning the trim knob and pressing. Saves patient data. Trend Displays trend data (see “Trend data” on page 21). Saves patient data. Home Pressing this button closes opened dialogues and returns to the monitoring screen. Any settings that were changed in the opened dialogue screen are saved. Pressing this button is the same as selecting OK on the opened dialogue screen. ON/OFF Press to switch the monitor on. Press and hold for 4 seconds to switch the monitor off. The LEDs below this button indicate: • Left LED - mains power is connected to the monitor. • Right LED - mains connected to the monitor and internal battery being charged. Trim knob The trim knob is used for navigation, value selection and value change. Use as follows: 1. Turn the trim knob to the left or right to select a field or value. A white frame appears around the field. 2. Press the trim knob to open the menu of the selected parameter field or value. 3. Turning the trim knob to the left or right to select the desired value. 4. Press the trim knob to apply the changed value.

Directions for use

Introduction

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Setup menu overview Press

to enter the Setup menu and adjust the following settings and options:

Parameter

Settings/Submenus

Alarm Suspend

Silences all alarms for a set period. The silence time is defined in the Administrator menu (alarms).

Arrhythmia1

Arrhythmia limits and alarm levels. Pacer Display and analysis (on/off).

Alarms

Alarm overview. All alarm limits and Print on Alarm settings.

Speaker Volume

Speaker volume.

HR/PR Tone Volume

Heart beat volume.

Waveforms

Defines the wave forms to be displayed and the size and sweep speed.

Recorder2

Defines the data on the printout.

Parameters

Enable/disable ETCO2 and invasive blood pressure.

12-lead Resting ECG3

View electrode status, and take a resting ECG. After the resting ECG has been taken, the option to obtain a printout is given.

Patient Information4

Enter/edit patient ID and patient data.

Patient Mode

Adult/Pediatric/Neonatal.

Restore User Defaults Reset all setting to user defaults (see next entry). Administrator

Close 1. 2. 3. 4.

Configuration Display of monitor ID, network settings, options, etc. This is for information only. Alarms Alarm settings - silence time, suspend time, etc. This requires a password to enter (see “Settings” on page 73). System Time date settings, volume, units (cm/in, kg/lb), etc. and also the event log and CO2 calibration timer. This screen requires a password to enter (see “Settings” on page 73). Communications, Service and Factory These menu options are for service and factory personnel and can only be accessed by password only. Details are given in the service handbook. Exits the setup menu.

The arrhythmia option is only viewable when the arrhythmia option is installed. The recorder option is only viewable when the printer is installed The 12-lead resting ECG option is only viewable when the resting ECG option is installed The patient Information menu option is not available when an Acuity enabled monitor is not connected to Acuity.

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Introduction

Welch Allyn 1500 Patient Monitor

Display overview Waveform fields

Time of last blood pressure measurement

Parameter fields

Alarm and system messages Blood pressure

Temperature

Information field See“Information field” below

Information field Top line The left box displays the patient’s room number (entered in the patient data screen). If the monitor is connected to the Acuity, the room number is taken from Acuity. The middle box displays the patient mode (Neonatal, Pediatric, or Adult) indicated by the highlighted icon. The right box indicates the monitor’s network connection: Connected to Acuity. Acuity enabled but no connection. When the Acuity option is not installed, this box remains blank.

Middle line Displays the patient name. If the monitor is connected to the Acuity, the patient name is taken from Acuity.

Bottom line Displays the current time. When mains is not connected a battery symbol is also displayed to the left of the time see “Battery operation” on page 17.

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3 Operation Startup and initial preparation WARNING Danger of electrical shock. Do not operate the monitor if the ground connection is suspect or if the mains lead is damaged or suspected of being damaged.

Connect and power up a

1.

b

Connect the mains cable to the rear of the monitor (a).

2. Connect the potential equalization (ground) cable to the central potential equalization lug (b). 3. Press the On/Off button

(confirmed by a beep).

4. Confirm the New Patient dialogue with Yes or No. •

Yes: Previous patient data is deleted. The patient data can be entered via the setup menu (Setup > Patient data) see “Patient information” on page 76.

•

No: Previous patient data, if any, is used.

5. Check the settings. Caution Ensure that the patient or any person with simultaneous patient contact does not come in contact with conductive parts of any connectors including the RJ45 connector and the USB connector when the cover is opened.

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Operation

Welch Allyn 1500 Patient Monitor

Turn the monitor on or off To turn the monitor on, press the On/Off button

.

To turn the monitor off, press the On/Off button for approximately 4 seconds. The following message is displayed when the monitor is shutting down.

Monitor is shutting down

please wait.

Power supply Mains connected When the mains supply is connected, the mains LED is illuminated (a). When the mains supply is connected, and the battery is recharging both mains LED (a) and the battery LED (b) are illuminated. For battery recharging see “Recharging the battery” on page 63.

a

b

Mains interrupted Note

If the mains supply is interrupted, the monitor automatically switches over to battery operation. The user settings are maintained.

Disconnect from the mains To isolate the monitor from the mains, disconnect the mains cable.

Directions for use

Operation

17

Battery operation Two batteries are available for the monitor: •

Lithium-Ion battery. This type of battery will provide power for approximately two hours when fully charged.

•

Lead acid battery: This type of battery will provide power for approximately one hour when fully charged.

When running on battery power the battery symbol is displayed next to the time. The battery indicator gives an approximate guide to the capacity of the battery: •

Full = between 87.5% and 100% capacity.

•

3/4 full = between 62.5% and 87.5% capacity.

•

Half full = between 37.5% and 62.5% capacity.

•

1/4 full = between 12.5% and 37.5% capacity

•

Empty = between 0% and 12.5% capacity.

When the battery capacity is close to depletion: •

the alarm message Battery low appears

•

the battery symbol flashes

•

an audible alarm beep is heard

•

the visual alarm indicator flashes blue Visual Alarm Indicator

•

After a few minutes if the monitor is not connected to the mains supply, the message Battery nearly depleted is displayed and a continuous beep is heard; the monitor switches off. If mains is connected during this period the monitor remains on.

Connect the monitor to the mains supply. For battery recharging see “Recharging the battery” on page 63.