Instructions for Use
52 Pages
Preview
Page 1
MD200
DESKTOP DOPPLER
CONTENTS CONTENU, INHALT, CONTENUTO, INNEHÅLL, INHOUD, CONTENIDOS, INHOLD
T AR / ST OP ST L CA
DE MO
- + - +
IN FOR SUTSRUCTIONS E
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
15 Femoral Artery VP4HS, VP5HS
14 16
Small Saphenous Vein VP8HS, EZ8
4
17
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 The product will automatically switch off after 5 minutes of no signal, except when connected to Dopplex Reporter software.
Do Not : • Immerse in any liquid, • use solvent cleaner, • use high temperature sterilising processes (such as autoclaving), • use E-beam or gamma radiation sterilisation.
When the battery symbol appears on LCD display, the battery needs recharging. MD200 can be powered by the mains when the battery is low. A standard IEC type socket is mounted on the rear panel. The internal batteries cannot be overcharged.
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.
After Use 1.
Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut- off.
Do not use in the eye. 2. Do not use vascular probes to detect the fetal heart.
Refer to the cleaning section before storing or using the unit on another patient.
3.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth. Avoid positioning the equipment such that access to the IEC power connector becomes difficult.
Probes and gel can be stored in the MD200.
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.
Any equipment connected to the serial port should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010.
Cleaning 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.
Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance.
Coupling Gel Use water based ultrasound gel ONLY.
3
ENGLISH
GENERAL OPERATION & MAINTENANCE
WARNING/CAUTIONS & SAFETY
ENGLISH
OPERATING INSTRUCTIONS VASCULAR
OPERATING INSTRUCTIONS VASCULAR The MD200 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. Flow towards the probe is in the left speaker and flow away from the probe is in the right speaker. The same applies to the stereo headphones when used. Probe frequency is displayed together with the bar graphs.
Gain Control To cope with the wide variety of signals detectable using your MD200, a gain control allows you to optimise the bar-graph display and increase the height of the waveforms. Using the Mode button on the MD200, gain can be set to x1, x2, x4, x8. Connection to Printa II 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 MD200. Printing is then initiated by using the Start/Stop button.
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 nonpulsatile sound similar to a rushing wind.
Note: Do not switch off the MD200 during printing as this will erase any information stored in the buffer box.
For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required.
Connection to Software
Waveform Recording
The MD200 can be connected to the Dopplex Reporter Software Package, via the RS232 interface. The Dopplex Reporter software package is available as an accessory. Communicating is then initiated by using the Start/Stop button.
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 Six probes are available for vascular examinations:
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.
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. IOP8 8MHz +-1% for Intraoperative use.
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, MD200 provides fetal heart rate (FHR) display with 3 operating modes, and outputs FHR for printing on the Printa II.
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.
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.
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.
2.
Standard Mode In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit readout. The LCD displays an outline heart symbol. Smoothed Mode
Release the Start/Stop button immediately on the count of 10 (i.e. After nine beat intervals). The MD200 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.
Probes
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.
OP2HS OP3HS
Manual Mode 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 MD200 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 MD200 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 - MD200”
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 MD200 without notice. Dopplex, Huntleigh and 'H' logo are registered trademarks of Huntleigh Technology Ltd 2004. ©Huntleigh Healthcare Ltd. 2004
6
ENGLISH
TECHNICAL SPECIFICATION Product Name:
MD200 Desktop Doppler
Model No.:
MD200
Physical Characteristics:
Weight : 1448 gms Height : 240mm
Width : 227mm
Speaker:
500mW rms typical
Headphones :
25 mW rms (32Ω headphones) (max applied voltage +9Vdc)
Audio Output:
Depth : 79mm
RS232:
8 pin sub miniature DIN socket, provides analogue and digital waveform outputs (max Applied voltage +5Vdc).
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 VP8HS)
Digital:
RS232C, 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 VP8HS) with zerobaseline at start and end of sequence.
Auto Shut-Off:
After 5 minutes of no signal
Battery Charging:
Recharge time, approximately 2 hours
Battery Life:
Typically, 400 x 1 minute examinations from full charge (depending on use)
Fuse:
T250mAH, 250V
Power Supply:
European version only - 230V ~ 50Hz 10VA USA version only - 120V ~ 60Hz 10VA Saudi Arabia Version Only - 220V ~ 50/60Hz 10VA ~ : Alternating Current Refer to rear panel for details of power supply option.
Probe Transmiter Frequencies:
OP2HS : OP3HS : VP4HS : VP5HS : VP8HS : VP10HS : EZ8 : IOP8:
Effective Area of Active Transmitter Element:
OP2HS, OP3HS : VP4HS, VP5HS : VP8HS, VP10HS : EZ8 : IOP8:
2.0MHz ± 1% 3.0MHz ± 1% 4.0MHz ± 1% 5.0MHz ± 1% 8.0MHz ± 1% 10.0MHz ± 1% 8.0MHz ± 1% 8.0MHz ± 1% 233 mm² (± 15%) 22 mm² (± 15%) 8 mm² (± 20%) 16 mm² (± 20%) 12.5 mm² (± 20%)
7
TECHNICAL SPECIFICATION FHR Performance :
Standard Mode Range - 60-210bpm Resolution - 1bpm Averaging - 4 beats Accuracy - ±3bpm
Complies With:
IEC 60601-1:1988/A2:1995, EN 60601-1:1990/A13:1996, UL 60601-1 1st Edition, CAN/CSA C22.2 No. 601.1-M90
Medical Electrical Equipment 25EA
Classification:
Environmental:
Smoothed Mode Range - 60-210bpm Resolution - 1bpm Averaging - 8 beats Accuracy - ±3bpm
Manual Mode Range - 60-210bpm Resolution - 1bpm Averaging - 10 beats Accuracy -±3bpm (excluding user error)
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY, IN ACCORDANCE WITH UL60601-1 and CAN/CSA C22.2 No 601.1. Type of shock protection
Class 1 mains powered equipment
Degree of shock protection
Type B equipment
Protection against water ingress
Not Protected - IPX0
Degree of safety in presence of flammable gases
Equipment not suitable for use in presence of flammable gases
Mode of operation
Continuous
Operation Temperature Relative Humidity Pressure
: : :
+10°C to +30°C 30% to 75% (non condensing) 700 to 1060hPa
: : :
-10°C to +40°C 20% to 90% (non condensing) 700 to 1060hPa
Transport and Storage Temperature Relative Humidity Pressure
A full technical description is provided in the Service Manual 752333.
Medical Devices Directive 93/42/EEC
Attention, consult accompanying documents / Instructions to Use
Attention: consult this manual. Refer to safety section.
8
MD200 7
8
4 10 START STOP/ CAL
3 - +
5
- + MODE
9
11
2
14
T AR / ST OP ST L CA
6
E MOD
- + - +
12
1
13
Huntleigh HEALTHCARE Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN Tel: +44 (0) 29 20485885 Fax: +44 (0) 29 20492520 www.huntleigh-diagnostics.com
DISTRIBUTED IN THE USA BY: ArjoHuntleigh, Inc. 2349 West Lake Street, ADDISON IL 60101 USA TEL: 800 223-1218
5 UL60601-1, CAN/CSA C22.2 No 601.1
VOLTAGE RATING
0088
IO
T250mAH 250V Medical Electrical Equipment 25EA
SERIAL No
MODEL No MD200
Manufactured in: UK
...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 Vertrieben in Deutschland durch: HNE Huntleigh Nesbit Evans Healthcare GmbH Industriering Ost 66, 47906 Kempen, Germany T: 02152-5511-10 F: 02152-5511-20 E: [email protected] Distributed in the USA by: ArjoHuntleigh Inc 2349 West Lake Street, Addison IL. 60101, USA T: 800 223-1218 www.huntleigh-healthcare.com Registered No: 942245 England. Registered Office: 310-312 Dallow Road, Luton, Beds, LU1 1TD
© Huntleigh Healthcare Limited 2004 AN ARJOHUNTLEIGH COMPANY. 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.
752321-8