MD2-SD2 Instructions for Use

CONTENTS CONTENU, INHALT, CONTENUTO, INNEHÅLL, INHOUD, CONTENIDOS, INDHOLD, SISÄLLYS

IN RU FOR ST USE CTIONS

BATTERY PILE, BATTERIE, BATTERIA, BATTERI, BATTERIJ, BATERÍA, BATTERI, PARISTO

1

Jugular Vein VP4HS, VP5HS

2

Subclavian Vein VP4HS, VP5HS

3

Fetus OP2HS, OP3HS

4

Femoral Vein VP4HS, VP5HS

5

6

11 Subclavian Artery VP4HS, VP5HS 12 Brachial Artery VP8HS, EZ8

9

1

10

13 Ulnar Artery VP8HS, EZ8

11

2

14 Radial Artery VP8HS, EZ8

12

Great Saphenous Vein VP5HS,VP8HS, EZ8

13

3

14 16

Small Saphenous Vein VP8HS, EZ8

4

17

15 Femoral Artery VP4HS, VP5HS 16 Digital Artery VP8HS, VP10HS, EZ8

15 7

Posterior Tibial Veins VP8HS, VP10HS, EZ8

8

Posterial Tibial Artery VP8HS, EZ8

9

Vertebral Artery VP4HS, VP5HS

10 Carotid Artery VP5HS, VP8HS, EZ8

17 Penis VP8HS, VP10HS, EZ8

5

18 Popliteal Artery VP5HS

18 6 7

8

20

19

19 Metatarsal Artery VP8HS, VP10HS, EZ8 20 Dorsalis Pedis Artery VP8HS, VP10HS, EZ8

Do not use Dopplers in the presence of flammable gases such as anaesthetic agents.

Refer to diagram on inside front cover for Doppler Measuring sites and Recommended Probes.

Do not use in the sterile field unless additional barrier precautions are taken.

During Use An automatic noise reduction feature operates on low level signals to improve sound quality.

Do Not : • Immerse in any liquid, • use solvent cleaner, • use high temperature sterilising processes (such as autoclaving), • use E-beam or gamma radiation sterilisation.

To replace battery see diagram. After Use

This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated. Do not use in the eye. If outputs 1 and 2 are used simultaneously, the system should comply with EN60601-1. Any equipment connected to outputs 1 or 2 should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010.

1.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 3 minutes.

2.

Refer to the cleaning section before storing or using the unit on another patient.

3.

Store unit together with probe and accessories in the soft carry case provided.

The control unit and the body of the probe are robust and require no special handling. However, the probe tip is delicate and must be handled with care.

Do not dispose of batteries in fire as this can cause them to explode.

Cleaning

Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode.

Remove excess gel before parking the probe. Clean with a damp cloth impregnated with mild detergent. Do not allow fluid to seep into either unit.

Dopplex Dopplers are screening tools to aid the healthcare professional and should not be used in place of normal vascular or fetal monitoring. If there is doubt as to vascularity or fetal well-being after using the unit, further investigations should be undertaken immediately using alternative techniques.

For disinfection use a soft cloth with Sodium Hypochlorite 1000ppm or alcohol. Alcohol saturated swabs can be used on the probe tip. Please be sure to check your local control of infection policies, or any equipment cleaning procedures.

We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA guidelines). This is considered to be good practice and should be observed at all times.

Phenolic, detergent based disinfectants containing cationic surfactants, ammonia based compounds, or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system.

Attention, consult accompanying documents / Instructions to Use

Coupling Gel

Means Attention consult this manual. Refer to safety section.

Use water based ultrasound gel ONLY. 3

ENGLISH

GENERAL OPERATION & MAINTENANCE

WARNING/CAUTIONS & SAFETY

ENGLISH

OPERATING INSTRUCTIONS VASCULAR

OPERATING INSTRUCTIONS VASCULAR The Multi Dopplex II/Super Dopplex II Dopplers (MD2/SD2) will select vascular mode when a vascular probe is connected to the control unit. In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

Gain Control To cope with the wide variety of signals detectable using your MD2/SD2, a gain control allows you to optimise the bar-graph display and increase the height of the waveforms. Using the Mode button on the MD2 (Gain button for SD2), gain can be set to x1, x2, x4, x8.

Clinical Use

Connection to Printa II (MD2 Only)

Apply a liberal amount of gel on the site to be examined. Place the probe at 45° to the skin surface over the vessel to be examined. Adjust the position of the probe to obtain the loudest audio signal. High pitched pulsatile sounds are emitted from arteries while veins emit a non-pulsatile sound similar to a rushing wind.

Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button. Connection to Software (MD2 Only)

For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required.

The MD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex Reporter software package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

Waveform Recording (MD2 only) Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Pin-out details on request).

Probes Five probes are available for vascular examinations: VP4HS

4MHz ±1% for deep lying vessels VP5HS 5MHz ±1% for deep lying vessels and oedematous limbs VP8HS 8MHz ±1% for peripheral vessels VP10HS 10MHz ±1% for specialist superficial applications. EZ8 8MHZ ±1% "Widebeam" for peripheral vessels.

Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa II or for communicating with Dopplex Reporter software package. Cal Function The baseline and sensitivity of the chart recorder can be set up using the Cal function. This generates a zero velocity baseline and a sequence of bi-directional pulses as shown below: Cal Pulses

4

Obstetric mode is automatically selected when an obstetric probe (OP2HS/OP3HS) is connected. In this mode, MD2 provides fetal heart rate (FHR) display with 3 operating modes, and outputs FHR for printing on the Printa II. The SD2 in obstetric mode provides audio only.

Use of Manual Mode

Clinical Use

1.

Apply a liberal amount of gel to the abdomen. Place the faceplate of the probe flat against the abdomen above the symphysis pubis. Adjust the probe to obtain an optimum audio signal ideally by angling the probe around. Avoid sliding it over the skin.

Press and hold Start/Stop button and immediately count the audible heart beats, counting the first beat as the button is pressed. The LCD displays the flashing clock symbol and the FHR reading is shown as three dashes.

2.

Release the Start/Stop button immediately on the count of 10 (i.e. After nine beat intervals). The MD2 will automatically calculate the derived FHR averaged over the 10 beat period and display the result. This rate value is retained until the measurement is repeated or the unit is switched off. If the button is held for a period less than about 3 seconds the display will clear the previous rate value and reset.

Mode Selection

In early pregnancy a full bladder may improve sound detection. In later pregnancy the best signals are generally located higher on the abdomen. The fetal heart sounds like a galloping horse at approximately twice the maternal rate. A wind-like sound is heard from the placenta. Standard Mode - MD2 Only In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit readout. The LCD displays an outline heart symbol.

Probes

Smoothed Mode - MD2 Only

OP2HS OP3HS

This mode is used to obtain more stable heart rate readings. In this mode, FHR is averaged over 8 beats. The LCD displays a solid heart symbol. Manual Mode - MD2 Only This mode is used when a fetal heart beat is audible in the loudspeaker or headphones but, due to noise or a low signal level, the MD2 cannot reliably calculate the heart rate. In this mode, the heart rate can be manually counted over a period of 10 audible heart beats (see below). The MD2 will automatically calculate and display the derived FHR on the LCD. The LCD displays a clock symbol.

5

2MHz ±1% 3MHz ±1%

ENGLISH

OPERATING INSTRUCTIONS OBSTETRICS

OPERATING INSTRUCTIONS OBSTETRICS

ENGLISH

WARRANTY & SERVICE

END OF LIFE DISPOSAL

Huntleigh Healthcare's standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns

This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures.

If for any reason your Dopplex Unit is being returned, please: 1.

Clean the product, as described in the cleaning section.

2.

Pack it in suitable packing.

3.

Attach the decontamination certificate (or other written statement declaring that the product has been cleaned) to the outside of the package.

4.

Mark the package "Service Department Multi/Super Dopplex II".

UK For further details refer to the NHS document HSG(93) 26. For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN UK Tel : +44 (0)29 20485885 Fax: +44 (0)29 20492520 Or your local distributor.

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 Multi Dopplex II or Super Dopplex II without notice. Dopplex, Huntleigh and 'H' logo are registered trademarks of Huntleigh Technology Ltd 2004. ©Huntleigh Healthcare Ltd. 2004

6

Product Name:

Multi/Super Dopplex® II

Model No.:

MD2/SD2

Physical Characteristics:

Weight : 295 gms Height : 140mm

Max. Audio Output:

Width : 74mm

Depth : 27mm

500mW rms typical

Max Headphones Output Power: 25 mW rms (32Ω headphones) (max. applied voltage +9Vdc) Auto Shut-Off: RS232 (MD2 Only):

After 10 minutes continuous operation or 3 minutes no signal RS232C, 8 pin sub-miniature DIN connector (max. applied voltage +5Vdc)

Waveform Outputs (MD2 only): Analogue:

Zero crosser, 3.5V full scale per channel (forward and reverse). Conversion factor automatically adjusted to give full scale outputs at ±0.1% (±10%) of probe frequency (e.g. ±8kHz for VP8)

Digital:

Data formatted to interface with Printa II or Recorder software running on compatible computer. Conversion factors automatically set as per analogue outputs.

CAL Function:

Automatic sequence of CAL levels set to ±0.05% (±10%) and ±0.1% (±10%) of probe frequency (e.g. ±4kHz & ±8kHz for VP8) with zero baseline at start and end of sequence.

Battery Type Recommended: 9 volt alkaline manganese (e.g. MN1604) Battery Life:

Typically, 250 x 1 minute examinations

Complies With:

BS5724: Part 1 : 1989, IEC 601-1: 1988, EN60601-1

FHR Performance :

Standard Mode Range - 60-210bpm Resolution - 1bpm Averaging - 4 beats Accuracy - ±3bpm

IEC601-1 Classification:

Type of shock protection Degree of shock protection Protection against water ingress Degree or safety in presence of flammable gases Mode of operation

Manual Mode Range - 60-210bpm Resolution - 1bpm Averaging - 10 beats Accuracy -±3bpm

Smoothed Mode Range - 60-210bpm Resolution - 1bpm Averaging - 8 beats Accuracy - ±3bpm

(excluding user error)

Environmental:

Internally powered equipment Type B equipment Ordinary equipment Equipment not suitable for use in presence of flammable gases Continuous

Operation

Transport and Storage

+10°C to +30°C

Temperature

-10°C to +40°C

10% to 90% (non condensing)

Relative Humidity

93% maximum

860 to 1060hPa

Pressure

860 to 1060hPa

A full technical description is provided in the Service Manual 726374.

Medical Devices Directive 93/42/EEC

7

ENGLISH

TECHNICAL SPECIFICATION

WARNING! Federal law restricts this device to sale by or on the order of a licensed practitioner. IMPORTANT

Before using your Multi/Super Dopplex, please study this manual carefully and familiarize yourself with the controls, displays, features and operating techniques. Do not use Dopplers in the presence of flammable gases such as anesthetic agents.

Attention, consult accompanying documents / Instructions to Use

Do not use in the sterile field unless additional barrier precautions are taken.

Attention! Consult this manual. Refer to Safety Section.

Do not :

• Immerse in any liquid • Use solvent cleaner • Use high temperature sterilizing processes (such as autoclaving) • Use E- beam or gamma radiation sterilization

Acoustic Safety Continuous wave Doppler ultrasound instruments such as the MD2/SD2 have been used extensively for medical diagnosis in the United States for over 25 years. Throughout this period, there have been no reports of adverse effects to patients or instrument operators at the acoustic intensities recommended for diagnostic use. Despite this highly favorable safety experience, available data are not conclusive and the possibility remains that unwanted biological effects might be identified in the future. Authorities therefore recommend that ultrasound procedures be performed in accordance with the "ALARA" principle, which states that the energy delivered to the patient should always be kept As Low As Reasonably Achievable. With the MD2/SD2, the transmitted acoustic power is fixed and cannot be adjusted by the operator. Therefore, the user can best observe the ALARA principle by ensuring that each examination is medically indicated and by limiting the duration of the study to the extent appropriate for the clinical objectives.

This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference be identified and eliminated. Do not use on the eyes or scrotum. If outputs 1 and 2 are used simultaneously, the system should comply with EN60601-1. Any equipment connected to outputs 1 or 2 should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010. Do not dispose of batteries in fire as this can cause them to explode. Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode. Dopplex Dopplers are screening tools to aid the healthcare professional and should not be used in place of normal vascular or fetal monitoring. If there is doubt as to vascularity or fetal well-being after using the unit, further investigations should be undertaken immediately using alternative techniques.

49

ENGLISH (USA)

WARNING/CAUTIONS & SAFETY

ENGLISH (USA)

WARNING/CAUTIONS & SAFETY Acoustic Safety (continued) Acoustic intensity data (ISPTA.3) for probes available for use with the MD/SD2 are summarized in the following table. The values cited are based on measurements in water using a calibrated hydrophone and are stated as the estimated derated intensities. The derated intensity constitutes the most biologically relevant parameter available since true determinations of actual absorbed dose in tissue would require invasive measurement techniques. The derated intensity is therefore calculated mathematically using a derating factor consisting of a constant (the assumed attenuation coefficient) and allowing for the frequency of the probe and the distance from the probe face to the hydrophone. The calculated derated intensity values for the MD/SD2 compare very favorably with previously reported acoustic safety data for Doppler ultrasound instruments and are appropriate for all clinical applications recommended in this manual. As the operating mode of the Dopplex range of probes is continuous wave, ISPPA figures are not applicable.

Acoustic Output Table, Track1, Non-Auto-Scanning Mode Model

Max. Value ISPTA.3

Wo

fc

Zsp

A-6, (Zsp)

EBD

OP2 HS

55

41

2.0

2.5

1.1

1.2 x 2.5

OP3 HS

55

32

3.0

2.0

1.2

1.2 x 2.5

VP4 HS

92

7.5

4.0

0.8

0.14

0.365 x 0.8

VP5 HS

92

8.2

5.0

0.8

0.12

0.365 x 0.8

VP8 HS

92

4.0

8.0

0.48

0.026

0.215 x 0.5

EZ8

92

14.3

8.0

0.67

0.064

0.635 x 0.22

VP10 HS

92

1.4

10.0

0.48

0.022

0.215 x 0.5

NOTES 1. Measurement uncertainty: varies with probe and measurement Random - typically ±20% (max. ±32%) Systematic - typically ±6.5% (max. ±8%)

Definition of Terms ISPTA.3

is the derated spatial-peak, temporal-average intensity (milliwatts per square centimeter) Wo is the ultrasonic power (milliwatts) fc is the center frequency (MegaHertz) Zsp is the axial distance used to calculate the derated intensity (centimeters) A-6 (Zsp) is ( /4) x (X-6 x Y-6) where X-6, Y-6 are respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the X-Y plane where Zsp is found (centimeters) EBD are the entrance beam dimensions for the azimuthal and elevational planes (centimeters)

50

Refer to diagram on inside front cover for Doppler Measuring Sites and Recommended Probes.

Cleaning Remove excess gel before replacing the probe. Clean with a damp cloth impregnated with mild detergent. Do not allow fluid to seep into either unit. For disinfection use a soft cloth with Sodium Hypochlorite 1000ppm or alcohol. Alcohol saturated swabs can be used on the probe tip.

During Use An automatic noise reduction feature operates on low level signals to improve sound quality. To replace battery see diagram on page 2.

Please be sure to check your local control of infection policies, or any equipment cleaning procedures. Phenolic, detergent based disinfectants containing cationic surfactants, ammonia based compounds, or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system.

After Use 1.

2.

3.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically switch off after 3 minutes. Refer to the cleaning section before storing or using the unit on another patient. Store unit together with probe and accessories in the soft carry case provided.

Coupling Gel Use water-based ultrasound gel ONLY.

The control unit and the body of the probe are robust and require no special handling. However, the probe tip is delicate and must be handled with care.

OPERATING INSTRUCTIONS VASCULAR The Multi Dopplex II/Super Dopplex II Dopplers (MD2/SD2) will select vascular mode when a vascular probe is connected to the control unit. In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required. Waveform Recording (MD2 Only) Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Connection details on request).

Clinical Use Apply a liberal amount of gel on the site to be examined. Place the probe at 45° to the skin surface over the vessel to be examined. Adjust the position of the probe to obtain the loudest audio signal. High pitched pulsatile sounds are emitted from arteries while veins emit a non-pulsatile sound similar to a rushing wind.

Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa or for communicating with Dopplex Reporter software package. 51

ENGLISH (USA)

GENERAL OPERATION & MAINTENANCE

ENGLISH (USA)

OPERATING INSTRUCTIONS VASCULAR

OPERATING INSTRUCTIONS OBSTETRICS

Cal Function The baseline and sensitivity of the chart recorder can be set up using the Cal function. This generates a zero velocity baseline and a sequence of bi-directional pulses as shown below:

IMPORTANT! READ THIS SECTION BEFORE USING YOUR Multi Dopplex.

Cal Pulses

Although the Multi Dopplex will calculate the rate as early in pregnancy as fetal pulse signals of good quality can be elicited, generally from about the 9th or 10th week after the last menstrual period, fetal heart rhythm may not be sufficiently stable to permit accurate rate computation until well after the first trimester.

Gain Control To cope with the wide variety of signals detectable using your MD2/SD2, a gain control allows you to optimize the bar-graph display and increase the height of the waveforms. Using the Mode button on the MD2, (Gain button for SD2), gain can be set to x1, x2, x4, x8.

Similarly, no attempt to apply nonstress test (NST) interpretation criteria should be made until after the 25th week of gestation, when neurological development is usually sufficient to obtain a reactive pattern. To be considered reactive, two accelerations at least 15 bpm in amplitude and at least 15 seconds in duration should occur in a 10 minute period.

Connection to Printa™ (MD2 only) Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button. Connection to Software (MD2 only) The MD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex Reporter Software Package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

If the fetus is found to be non-reactive using the Multi Dopplex hand-held sampling technique, consideration should be given to repeating the test using a conventional fetal monitor.

Probes Five probes are available for vascular examinations: VP4 HS

4MHz ±1% for deep lying vessels

VP5 HS

5MHz ±1% for deep lying vessels and edematous limbs

VP8 HS

8MHz ±1% for peripheral vessels

The Multi Dopplex is suitable for intermittent auscultation during the intrapartum period, but not recommended for long term intrapartum monitoring, where Cardiotocographic equipment, including contractions measurement capability should be employed.

VP10 HS 10MHz ±1% for specialist superficial applications. EZ8

8MHz ±1% “Widebeam” for peripheral vessels 52

Obstetric mode is automatically selected when an obstetric probe (OP2/OP3) is connected. In this mode, MD2 provides fetal heart rate (FHR) display with 3 operating modes, and outputs FHR for printing on the Printa™. The SD2 in obstetric mode provides audio only.

Mode Selection

Clinical Use

Use of Manual Mode

Apply a liberal amount of gel to the abdomen. Place the faceplate of the probe flat against the abdomen above the symphysis pubis. Adjust the probe to obtain an optimum audio signal ideally by angling the probe around. Avoid sliding it over the skin. In early pregnancy a full bladder may improve sound detection. In later pregnancy the best signals are generally located higher on the abdomen. The fetal heart sounds like a galloping horse at approximately twice the maternal rate. A wind-like sound is heard from the placenta. Standard Mode - MD2 only In this mode the FHR, averaged over 4heart beats, is displayed on the 3-digit readout. The LCD displays an outline heart symbol. Smoothed Mode - MD2 Only This mode is used to obtain more stable heart rate readings. In this mode, FHR is averaged over 8 beats. The LCD displays a solid heart symbol.

1.

Press and hold Start/stop button and immediately count the audible heart beats, counting the first beat as the button is pressed. The LCD displays the flashing clock symbol and the FHR reading is shown as three dashes.

2.

Release the Start/Stop button immediately on the count of 10 (i.e. after nine beat intervals). The MD2 will automatically calculate the derived FHR averaged over the 10 beat period and display the result. This rate value is retained until the measurement is repeated or the unit is switched off. If the button is held for a period less than about 3 seconds the display will clear the previous rate value and reset.

Connection to Printa™ (MD2 Only) Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button.

Manual Mode - MD2 Only This mode is used when a fetal heart beat is audible in the loadspeaker or headphones but, due to noise or a low signal level, the MD2 cannot reliably calculate the heart rate. In this mode, the heart rate can be manually counted over a period of 10 audible heart beats (see opposite). The MD2 will automatically calculate and display the derived FHR on the LCD. The LCD displays a clock symbol.

Probes for obstetric applications OP2 HS : 2MHz ±1% OP3 HS : 3MHz ±1%

53

ENGLISH (USA)

OPERATING INSTRUCTIONS OBSTETRICS

ENGLISH (USA)

WARRANTY a) ARJOHUNTLEIGH INC. HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES (INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) AND ANY AGREEMENTS, REPRESENTATIONS, AFFIRMATIONS, OR WARRANTIES, WHETHER ORAL OR WRITTEN, MADE BY ANY AGENT, EMPLOYEE OR REPRESENTATIVE OF ARJOHUNTLEIGH INC., UNLESS SPECIFICALLY SET FORTH IN THIS PARAGRAPH. ARJOHUNTLEIGH INC. SHALL NOT BE LIABLE FOR BREACH OF CONTRACT ARISING FROM ANY DEFECT IN MATERIAL OR WORKMANSHIP OF THE GOODS. ALL LEGISLATION RELATING TO EXPRESS AND IMPLIED WARRANTIES OR OTHER OBLIGATIONS ON THE PART OF ARJOHUNTLEIGH INC. THAT MAY BE LAWFULLY EXCLUDED ARE HEREBY EXCLUDED.

b) Notwithstanding the foregoing, ArjoHuntleigh Inc.’s sole warranty is that the Goods shall be free from defects in material and workmanship for a period of three (3) years (excluding probe head and retractile cable which are warranted for one (1) year, following delivery of such Goods to the original purchaser; provided that the Goods were used in an appropriate and reasonable manner during such period and provided further that ArjoHuntleigh Inc. shall be in no event be liable to Customer for defective Goods if: (i) the Goods are damaged in the course of shipping; (ii) any defect is caused wholly or to any material extent by customer’s negligence, misuse, failure to use the Goods properly or use of the Goods in conjunction with any accessory not approved for use with the Goods by ArjoHuntleigh Inc.; (iii) the Goods are damaged as a result of improper maintenance, failure to follow manufacturer’s instructions, including without limitation those on washing and cleaning, or failure to follow necessary routine maintenance procedures; or (iv) the Goods are altered, repaired or dismantled other than with manufacturer’s written authorization using its approved procedures or by any party other than manufacturer’s properly qualified and trained technicians.

c) Customer must provide written notice to ArjoHuntleigh Inc., within said warranty period of any defect in the Goods. Upon ArjoHuntleigh Inc.’s written request, Customer must return such Goods adequately packed (in their original packing) and fully insured to ArjoHuntleigh Inc.’s place of business and shall be responsible for all shipping costs incurred therein. Customer’s exclusive remedy and ArjoHuntleigh Inc.’s exclusive liability for any claim for loss, damage or destruction resulting from any defects in materials and workmanship shall be limited to repair, service, adjustment or replacement (at ArjoHuntleigh Inc.’s option) of any nonconforming or defective Goods. ArjoHuntleigh Inc. will have a reasonable time to repair, service or replace such Goods. Any Goods returned to ArjoHuntleigh Inc. which are found not to be defective in breach of the warranty in Subsection (b) above, shall be returned to the Customer in the manner described in this subsection.

d) IN NO EVENT SHALL ARJOHUNTLEIGH INC. BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES (INCLUDING BUT NOT LIMITED TO ECONOMIC LOSS, LOSS OF PROFITS OR SPECIAL DAMAGES) ARISING OUT OF OR INCURRED BY CUSTOMER IN CONNECTION WITH THE PURCHASE OF ARJOHUNTLEIGH INC.’S GOODS EVEN IF ARJOHUNTLEIGH INC. HAS BEEN ADVISED OR HAS KNOWLEDGE OF THE POSSIBILITY OR EXTENT OF SUCH DAMAGES SUFFERED OR INCURRED BY CUSTOMER OR ANY END USER AS A RESULT OF OR IN CONNECTION WITH ANY BREACH OF THESE TERMS AND CONDITIONS BY ARJOHUNTLEIGH INC. OR ANY TORT (INCLUDING BUT NOT LIMITED TO STRICT LIABILITY OR NEGLIGENCE) COMMITTED BY ARJOHUNTLEIGH INC., ITS AGENTS OR REPRESENTATIVES IN CONNECTION WITH THESE TERMS AND CONDITIONS OR ANY CONTRACT WITH CUSTOMER FOR THE SUPPLY OF GOODS.

54

e) Customer shall not create, directly or indirectly, any warranty obligations on the part of ArjoHuntleigh Inc. to the customers of Customer, and in particular, without limiting the foregoing, Customer agrees not to pass on to its customers any warrantiesbeyond or in addition to those given by ArjoHuntleigh Inc. to Customer hereunder. Where the Customer is a dealer in the Goods, it shall be responsible for the labor cost of all repairs and ArjoHuntleigh Inc. shall be responsible for providing all repair parts during said three (3) year (excluding probe head and retractivel cable which are warranted for one (1) year). The dealer shall provide written verification of warranty repairs including the original invoice number, date of purchase, description of repairs, name of its customer and date of sale to such customer.

f) Customer shall be deemed to have full knowledge of the nature and properties of the Goods ordered and of any hazards they involve and the proper treatment, storage and handling thereof. Any technical advice furnished by ArjoHuntleigh Inc. or its representatives or agents is given only on the basis that it is followed at the Customer’s own risk.

55

ENGLISH (USA)

WARRANTY

ENGLISH (USA)

SERVICE

END OF LIFE DISPOSAL

Service Returns There are NO USER SERVICEABLE PARTS inside the control unit or probe. If for any reason your Dopplex Unit is being returned, please: 1.

Clean the product, as described in the cleaning section.

2.

Pack in suitable packing.

3.

Attach the decontamination certificate, (or other written statement declaring that the product has been cleaned), to the outside of the package.

4.

Call Huntleigh in Addison, IL for a return authorization number.

This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures.

For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Service Department ArjoHuntleigh Inc. 2349 West Lake Street, Addison, IL 60101, USA T: (800) 223-1218 Or your local distributor.

Manufactured in the UK by Huntleigh Healthcare. As part of the ongoing development programme, the company reserves the right to modify specifications and materials of the Multi Dopplex II and Super Dopplex II without notice. Dopplex, Huntleigh and ‘H’ logo are registered trademarks of Huntleigh Technology Ltd. 2003. ©Huntleigh Healthcare 2003

56

Product Name:

Multi/Super Dopplex® II

Model No.:

MD2/SD2

Physical Characteristics:

Weight : Height :

Max. Audio Output:

500mW rms typical

Max Headphones Output Power:

10oz including probe and battery 5.5” Width : 2.9” Depth : 1.1”

25 mW rms max. (32Ω headphones) (max. applied voltage +9Vdc)

Auto Shut-Off:

After 10 minutes continuous operation or 3 minutes no signal

RS232 (MD2 Only):

RS232C, 8 pin sub-miniature DIN connector (max. applied voltage +5Vdc)

Waveform Outputs (MD2 only): Analogue:

Zero crosser, 3.5V full scale per channel (forward and reverse). Conversion factor automatically adjusted to give full scale outputs at ±0.1% (±10%) of probe frequency (e.g. ±8kHz for VP8)

Digital:

Data formatted to interface with Printa or Recorder software running on compatible computer. Conversion factors automatically set as per analogue outputs.

CAL Function:

Automatic sequence of CAL levels set to ±0.05% (±10%) and ±0.1% (±10%) of probe frequency (e.g. ±4kHz & ±8kHz for VP8) with zero baseline at start and end of sequence.

Battery Type Recommended:

9 volt alkaline manganese (e.g. MN1604)

Battery Life:

Typically, 250 x 1 minute examinations

Complies With:

BS5724: Part 1 : 1989, IEC 601-1: 1988, EN60601-1

FHR Performance :

Standard Mode Smoothed Mode Range Range 60-210bpm 60-210bpm Resolution - 1bpm Resolution - 1bpm Averaging Averaging 4 beats 8 beats Accuracy - ±3bpm Accuracy - ±3bpm

IEC601-1 Classification:

Type of shock protection Internally powered equipment Degree of shock protection Type B equipment Protection against water ingress Ordinary equipment Degree of safety in presence Equipment not suitable for use in of flammable gases presence of flammable gases Mode of operation Continuous

Environmental:

Operation

Manual Mode Range 60-210bpm Resolution - 1bpm Averaging 10 beats Accuracy - ±3bpm (excluding user error)

Transport and Storage

+10°C to +30°C

Temperature

-10°C to +40°C

10% to 90% (non condensing)

Relative Humidity

93% maximum

860 to 1060hPa

Pressure

860 to 1060hPa

A full technical description is provided in the Service Manual 726374. 57

ENGLISH (USA)

TECHNICAL SPECIFICATIONS

6

5

4

1 2

14

3

12

MD2/SD2

11

10

9

8

7

13

Ein/ Ausschalter Volume Control Lautstärkeregler CAL-Schalter

Bouton Marche/Arrêt

Contrôle du volume

Bouton Marche/ Arrêt

Bouton calibrage

Bouton mode

Bouton de gain

On/Off Button

Volume Control

Start/Stop Button

Cal Button

Mode Button

Gain Button

7

8

9

10

11

Pocket Clip Attachment

Probe Holder

14

Fermaglio da taschino Reggi-sonda

Zub. Taschenclip Sondenhalterung

Rangement sonde

Vano batteria

Tasto Guadagno

Verstärkerknopf

sensor holder

Compartimento para sonda Positie van sonde Probeparkering

Lomme clips

Clip para bolsillo

Batteri rum

Compartimento para pila

Zakclip

Vahvistuspainike

volumen knap Botón de ganancia

Fästanordning för ficka

Toimintatilapainike

Indstillingsknap Botón de modo

Koettimen pidin

Taskupidikeliitin

Paristolokero

Kal-painike

Kalibre-rings knap Botón de Calibrado

Äänenvoimak -kuussäädin Start/Stoppainike

Volume kontrol start/stop knap

Botón de Inicio y detención

Kaiutin

Nestekidenäyttö (LCD)

RS232-portti

Aaltomuotovastake

Kuulokevastake

SUOMI

tænd og sluk On/Off-painike knap

højtaler

LCD Panel

RS232 port

wawe form holder

Hoved-telefon holder

DANSK

Batterij-holte

Versterkinksknop

Functie-knop

Cal-knop

Start/Stopknop

Control du Volumen

Botón de Encendido/ Apagado

Altavoz

Panel LCD

RS232

Salida para gráfica

Entrada de auriculares

ESPAÑOL

Batterifack

Volym-knop

Inställings knapp

Tasto Modalità

Modus-knopf

Start/Stopknapp Kalibreringsknapp

Tasta Avviamento /Arresto Pulsante Cal

Batteriefach

Aan/uitschakelaar

Luid-sprecker

Högtalare

På/Av knapp

LCD-Paneel

Poort RS232

RS232 Ingång LCD indikatkor

Golvformcontact

Hoofdstelcontact

NEDERLANDS

Vågformsuttag

Uttag för hörlurar

SVENSKA

Regolatore di Volym-kontroll Volume-knop volume

Interruttore on/off

Alto-parlante

Clip

Battery Compartment Logement pile

13

12

6

Laut-sprecher

Haut-parler

Loud-speaker

5

Panello a cristalli liquidi

LCD-Feld

Affichage à cristaux liquides

LCD Panel

4

Porta RS232

RS232 Schnittstelle

Port RS232

RS232 Port

3

Presa segnale

Buchse Meßkurven

Prise générateur d’ondes

Waveform Socket

2

Presa cuffia

Buchse Kopfhörer

Head-phone Socket

1

Prise casque

FRANÇAIS

ENGLISH

ITALIANO

SD 2 DEUTSCH

MD 2

Visit our Website for downloadable clinical & educational material and product information

...with people in mind Huntleigh Healthcare Ltd. - Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 F: +44 (0)29 20492520 E: [email protected] W: www.huntleigh-diagnostics.com DISTRIBUTED IN GERMANY BY: HNE Huntleigh Nesbit Evans Healthcare GmbH Industriering Ost 66, 47906 Kempen T: 02152 551110 F: 02152 551120 E: [email protected] DISTRIBUTED IN THE USA BY: ArjoHuntleigh Inc. 2349 West Lake Street, Addison, IL 60101, USA T: 800-223-1218 Registered No: 942245 England. Registered Office: 310-312 Dallow Road, Luton, Beds, LU1 1TD

© Huntleigh Healthcare Limited 2004

MEMBER OF THE GETINGE GROUP ® and ™ are trademarks of Huntleigh Technology Limited As our policy is one of continous improvement, we reserve the right to modify designs without prior notice.

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