Specifications. Welch Allyn 42MTB, 420TB, 42NTB, 42NOB, 42MOB, 4200B

9

Specifications

Patient Population

The Welch Allyn Spot Vital Signs is designed for use with adult and pediatric patients.

Welch Allyn defines a pediatric patient as 29 days or more of age.

THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATES

.

Welch Allyn defines neonates as children 28 days or less of age, born at term (37 weeks gestation or more), otherwise up to 44 gestational weeks.

Blood Pressure

Cuff Pressure Range

Cuff Inflation Factory

Default

Systolic Range

Diastolic Range

Accuracy

Determination Time

Pulse Rate Range

Pulse Rate Accuracy

Overpressure Cutoff

0 mmHg to 300 mmHg

160 mmHg

60 mmHg to 250 mmHg

30 mmHg to 160 mmHg

Blood pressure accuracy meets or exceeds SP10-1992 AAMI standards for non-invasive blood pressure accuracy (AAMI standard: ± 5 mmHg mean error,

8 mmHg standard deviation). Blood pressure accuracy is validated for pressure measurement using the upper arm only.

Typical: 20 to 45 seconds

Maximum: 165 seconds

40 bpm to 200 bpm

±5.0%

305 mmHg -0/+15 mmHg

Temperature

Accuracy

Range

Determination Time

Calibration accuracy: + 0.2° F (+ 0.1° C).

Maximum: 109.4° F/43.0° C

Minimum:

86.0° F/30.0° C

Oral: approximately 4 seconds

Axillary: approximately 10 seconds

Rectal: approximately 15 seconds

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Welch Allyn Spot Vital Signs

Pulse Oximetry

Masimo Sensor Accuracy Guide

Accuracy specified when used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules using Masimo patient cables, during no motion. Numbers present ± 1 standard deviation. Plus or minus one standard deviation represents 68% of the population. SpO

2

accuracy from 70% to 100%. Pulse rate accuracy from 25 to 240 bpm.

Performance Measurement Range

Perfusion

SpO

2

Accuracy

Pulse Rate Accuracy

SpO

2

: 70 to 100%

Pulse Rate: 25 - 240 beats per minute (BPM)

0.02% to 20%

Saturation: 70% to 100%

No Motion: Adults, Pediatrics ± 2 digits

Motion: Adults, Pediatrics ± 3 digits

Low Perfusion: Adults, Pediatrics ± 2 digits

Pulse Rate: 25 to 240 bpm

No Motion: Adults and Pediatrics ± 3 digits

Motion: Adults and Pediatrics ± 5 digits

Low Perfusion: Adults and Pediatrics ± 3 digits

Table 14. Masimo Sensor Accuracy Guide

Sensor

LNCS-DCI

LNCS-DCIP

LNCS-ADTX

LNCS-PDTX

LNCS INF-L

LNOP-DCI

LNOP-DCIP

LNOP-ADT

LNOP-PDT

LNOP INF-L

Weight Range

> 30 kg

10 to 50 kg

> 30 kg

10 to 50 kg

3 to 20 kg

> 30 kg

10 to 50 kg

> 30 kg

10 to 50 kg

3 to 20 kg

Saturation Accuracy

No Motion

± 2%

± 2%

± 2%

± 2%

± 2%

± 2%

± 2%

± 2%

± 2%

± 2%

Motion

± 3%

± 3%

± 3%

± 3%

± 3%

± 3%

± 3%

± 3%

± 3%

± 3%

Pulse Rate Accuracy

No Motion

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

± 3 bpm

Motion

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

± 5 bpm

Masimo Patents

The Masimo sensors and cables are covered under one or more of the following U.S.A. patents: 5,758,644; 5,823,950; 6,011,986; 6,157,850; 6,263,222; 6,501,975; and other applicable patents listed at www.masimo.com/patents.htm.

Directions for Use

45

Nellcor

®

Sensor Accuracy Guide

Accuracy specifications are based on controlled hypoxia studies with healthy, non-smoking adult volunteers over the specified saturation SpO

2 range. Pulse oximeter

SpO

2

readings were compared to SaO

2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as + “X” digits. This variation equals plus one standard deviation (+ 1 SD), which encompasses 68% of the population.

Pulse Rate Range

Pulse Rate Accuracy

25 to 240 bpm

±3 bpm

±3 bpm (low perfusion)

Table 15. OxiMax Sensor Models, Single Patient Use

Sensor Models

MAX-AI

MAX-PI

MAX-II

MAX-RI

1

1

The accuracy specification has been determined between saturations of 80% to 100%.

SpO

2

Range

70% to 100%

± 2

± 2

± 2

± 3.5

Table 16. OxiCliq Sensor Models, Single Patient Use

Sensor Models

OXICLIQ-PI

SpO

2

Range

70% to 100%

± 2.5

Table 17. Reusable Sensor Models

Sensor Models

D-YS (Infant to Adult)

D-YS and D-YSE

D-YS and D-YSPD

DS-100A

OXI-A/N (Adult)

OXI-P/I (Pediatric/infant)

SpO

2

Range

70% to 100%

± 3

± 3.5

± 3.5

± 3

Adult: ± 3

± 3

Nellcor Patents

Covered by one or more of the following US Patents: 4,802,486; 4,869,254; 4,928,692;

4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364;

5,865,736; 6,083,172; 6,708,049; Re. 35,122 and foreign equivalents.

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Welch Allyn Spot Vital Signs

Mechanical

Dimensions

Weight

Mounting

Height: 9.7 inches (24.6 cm)

Length: 5.7 inches (14.5 cm)

Depth: 4.7 inches (12.0 cm)

Approximately 4.6 pounds (2.2 kg)

Self-supporting on rubber feet

Custom Mobile Stand

Custom Wall Mount

Custom IV Pole Mount

May be hand-carried when held by the rear handle.

Portability

Electrical

Power Requirements

Battery

Patient-rated isolation transformer is connected to AC mains:

North American Version:120VAC, 60Hz. 0.13A Input, 7.2VDC, 1.0A Output

International Version:240VAC, 50Hz 0.065A Input, 7.2VDC, 1.0A Output

Australian Version:240VAC, 50Hz, 13VA Input, 7.2VDC, 1.0A Output

Lead acid, with external charger.

A fully charged battery supports 130 typical blood pressure determinations taken at

7-minute intervals. The battery is 90-100% charged after 12 hours of charging. The battery automatically charges when the Spot Vital Signs is powered through the AC power transformer. The battery charges faster when the instrument is not in operation.

Environmental

Operating Temperature

Storage Temperature

Transport Temperature

Relative Humidity

Operating Altitude

+10

°

to +40

°

C (Thermometer operating temperature 16° to 40° C)

+50

°

to +104

°

F (Thermometer operating temperature 61° to 104° F)

-20

°

to +50

°

C

-4

°

to +122

°

F

-20

°

to +49

°

C

-4

°

to +122

°

F

15 to 90% (non-condensing)

-170 to +4877 m

-557 to +16,000 ft.

Directions for Use

Guidance and Manufacturer’s Declaration

Emissions and Immunity Information

Electromagnetic Emissions

The 420 Series Spot Vital Signs is intended for use in the electromagnetic environment specified below. The customer or user of the 420 Series

Spot Vital Signs should assure that it is used in such an environment.

Emissions Test

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Compliance

Group 1

Class B

Class A

Complies

Electromagnetic Environment - Guidance

The 420 Series Spot Vital Signs uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The 420 Series Spot Vital Signs is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Welch Allyn Spot Vital Signs

Electromagnetic Immunity

The 420 Series Spot Vital Signs is intended for use in the electromagnetic environment specified below. The customer or user of the 420 Series

Spot Vital Signs should assure that it is used in such an environment.

Immunity Test IEC 60601

Test Level

± 6 kV contact Electrostatic discharge

(ESD)

± 8 kV air

IEC 61000-4-2

Electrical fast transient/ burst

±2 kV for power supply lines

Compliance Level

± 6 kV contact

± 8 kV air

±2 kV for power supply lines

Electromagnetic Environment - Guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines.

IEC 61000-4-11

Power frequency

(50/60Hz) magnetic field

IEC 61000-4-8

±1 kV for input/output lines

±1 kV differential mode

±1 kV for input/output lines

±1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment.

±2 kV common mode

>95% dip in 0.5 cycle

±2 kV common mode

>95% dip in 0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

60% dip in 5 cycles

30% dip for 25 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the 420 Series Spot Vital

Signs requires continued operation during power mains interruptions, it is recommended that the 420 Series Spot Vital

Signs be powered from an uninterruptible power supply or battery.

>95% dip in 5 seconds

3 A/m

>95% dip in 5 seconds

3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Directions for Use

49

Electromagnetic Immunity

The 420 Series Spot Vital Signs is intended for use in the electromagnetic environment specified below. The customer or user of the 420 Series

Spot Vital Signs should assure that it is used in such an environment.

Immunity Test IEC 60601

Test Level

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Compliance

Level

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the 420 Series Spot Vital Signs including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

V1 = 3 Vrms

d

= (1.17)

P

E1 = 3 V/m

d

= (1.17)

P

80 MHz to 800 MHz

d

= (2.33)

P

800 MHz to 2.5 GHz where

P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and

d

is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a

should be less than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 420

Series Spot Vital Signs is used exceeds the applicable RF compliance level above, the 420 Series Spot Vital Signs should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 420 Series

Spot Vital Signs.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Welch Allyn Spot Vital Signs

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the 420 Series Spot

Vital Signs

The 420 Series Spot Vital Signs is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the 420 Series Spot Vital Signs can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 420 Series Spot Vital Signs as recommended below, according to the maximum output power of the communications equipment.

Rated Max. Output

Power of Transmitter

(W)

0.01

0.1

1

10

100

Separation Distance According to Frequency of Transmitter (m)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d

= (1.17)

P

0.11667

0.36894

1.1667

3.6894

11.667

d

= (1.17)

0.11667

0.36894

1.1667

3.6894

11.667

P

d

= (2.33)

0.23333

0.73785

2.3333

7.3785

23.333

P

For transmitters rated at a maximum output power not listed above, the recommended separation distance

d

in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where

P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Directions for Use

Patents

D392,043 and other patents pending.

Agency Approvals

CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1

CONFORMS TO: IEC 60601, UL STD 60601-1

Welch Allyn PTY, Ltd - Australia

Metro Centre

Unit 5/38 South Street

Rydalmere NSW 2116, Australia

EMC Framework of Australia

The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/

EEC Medical Device Directive.

EC REP

Authorized European Representative Address:

European Regulatory Manager

Welch Allyn Ltd.

Navan Business Park

Dublin Road

Navan, County Meath, Republic of Ireland

Tel.: +353 46 90 67700 • Fax: +353 46 90 67756

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Welch Allyn Spot Vital Signs